SEX HORMONES

Safety and efficacy have not been adequately determined in children and adolescents. Pre-pubertal children treated with SUST 250 should be treated with caution.

Female-to-male transsexuals:

Different specialist centres have used doses varying from one injection of 1ml every two weeks to one injection of 1ml every four weeks.

Method of administration

SUST 250 should be administered by deep intramuscular injection.

Contraindications

• Pregnancy.

• Known or suspected carcinoma of the prostate or breast.

• Breast-feeding.

• Hypersensitivity to the active substance or to any of the excipients, including arachis oil. SUST 250 is therefore contraindicated in patients allergic to peanuts or soya.

Special warnings and precautions for use

Medical examination:

Testosterone level should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels.

Physicians should consider monitoring patients receiving SUST 250 before the start of treatment, at quarterly intervals for the first 12 months and yearly thereafter for the following parameters:

• Digital rectal examination (DRE) of the prostate and PSA to exclude benign prostate hyperplasia or a sub-clinical prostate cancer,

• Haematocrit and haemoglobin to exclude polycythaemia.

In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin, and haematocrit, liver function tests and lipid profile.

Conditions that need supervision:

Patients, especially the elderly, with the following conditions should be monitored for:

• Tumours - Mammary carcinoma, hypernephroma, bronchial carcinoma and skeletal metastases. In these patients hypercalcaemia or hypercalciuria may develop spontaneously, also during androgen therapy. The latter can be indicative of a positive tumour response to the hormonal treatment. Nevertheless, the hypercalcaemia or hypercalciuria should first be treated appropriately and after restoration of normal calcium levels, hormone therapy can be resumed.

• Pre-existing conditions -

In patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. In such cases treatment must be stopped immediately. Patients who experienced myocardial infarction, cardiac-, hepatic- or renal insufficiency, hypertension, epilepsy, or migraine should be monitored due to the risk of deterioration of or reoccurrence of disease. In such cases treatment must be stopped immediately.

Testosterone may cause a rise in blood pressure and SUST 250 should be used with caution in men with hypertension.

• Epilepsy or Migraine - (or a history of these conditions), since androgens may occasionally induce fluid and sodium retention.

• Diabetes mellitus – Androgens in general and SUST 250 can improve glucose tolerance in diabetic patients

• Anti-coagulant therapy – Androgens in general and SUST 250 can enhance the anti-coagulant action of coumarin-type agents

• Sleep apnoea- Caution should be applied when treating men with sleep apnoea. There have been reports that testosterone can cause or exacerbate pre-existing sleep apnoea. However, there is a lack of evidence regarding the safety of testosterone in men with the condition. Good clinical judgment and caution should be employed in patients with risk factors such as adiposity or chronic lung diseases.

Adverse events:

If androgen-associated adverse reactions occur, treatment with SUST 250 should be discontinued and, upon resolution of complaints, resumed with a lower dose.

Virilisation:

Patients should be informed about the potential occurrence of signs of virilisation. In particular, singers and women with speech professions should be informed about the risk of deepening of the voice. The voice changes may be irreversible.

If signs of virilisation develop, the risk/benefit ratio has to be newly assessed with the individual patient.

(Mis)use in sports:

Patients who participate in competitions governed by the World Anti-Doping Agency (WADA) should consult the WADA-code before using this product as SUST 250 can interfere with anti-doping testing. The misuse of androgens to enhance ability in sports carries serious health risks and is to be discouraged.

Excipients:

SUST 250 contains Arachis oil (peanut oil) and should not be taken / applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid SUST 250

SUST 250 contains 100 mg benzyl alcohol per ml solution and must not be given to premature babies or neonates. Benzyl alcohol may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.

Female-to-male transsexual supportive therapy:

Before initiating SUST 250 for female-to-male transsexuals, specialist assessment should be undertaken, including psychiatric assessment. A complete personal and medical history should be taken. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual. The following should be monitored:

▪ signs of osteoporosis,

▪ changes in lipid profile.

In patients with a personal or family history of breast cancer and with a personal history of endometrial cancer, careful monitoring should be undertaken.

Subject to specialist advice, hysterectomy and bilateral oophorectomy should be considered after 18-24 months of testosterone treatment, to reduce the possible increased risk of endometrial and ovarian cancer.

Continued surveillance is required to detect osteoporosis in patients who have undergone oophorectomy, as testosterone may not fully reverse the decline in bone density in these patients.

Continued surveillance is required to detect endometrial and ovarian cancer in patients on long term treatment who have not proceeded to hysterectomy and bilateral oophorectomy.

Paediatric population:

In pre-pubertal children statural growth and sexual development should be monitored since androgens in general and SUST 250 in high dosages may accelerate epiphyseal closure and sexual maturation.

Older People:

There is limited experience on the safety and efficacy of the use of SUST 250 in patients over 65 years of age. Currently, there is no consensus about age specific testosterone reference values. However, it should be taken into account that physiologically testosterone serum levels are lower with increasing age.

Interaction with other medicinal products and other forms of interaction

Enzyme-inducing agents may decrease and enzyme-inhibiting drugs may increase testosterone levels. Therefore, adjustment of the dose of SUST 250 may be required.

Insulin and other anti-diabetic medicines:

Androgens may improve glucose tolerance and decrease the need for insulin or other anti-diabetic medicines in diabetic patients

Patients with diabetes mellitus should therefore be monitored especially at the beginning or end of treatment and at periodic intervals during SUST 250 treatment.

Anti-coagulant therapy:

High doses of androgens may enhance the anticoagulant action of coumarin type agents. Therefore, close monitoring of prothrombin time and if necessary a dose reduction of the anti-coagulant is required during therapy.

ACTH or Corticosteroids:

The concurrent administration of testosterone with ACTH or corticosteroids may enhance oedema formation therefore these active substances should be administered cautiously, particularly in patients with cardiac or hepatic disease or in patients predisposed to oedema

Laboratory test interactions:

Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, and there is no clinical evidence of thyroid dysfunction.

Fertility, pregnancy and lactation

SUST 250 is contra-indicated in women who are pregnant

Pregnancy:

There are no adequate data for the use of SUST 250 in pregnant women. In view of the risk of virilisation of the foetus, SUST 250 should not be used during pregnancy. Treatment with Sustanon should be discontinued when pregnancy occurs.

Lactation:

There are no adequate data for the use of SUST 250 during lactation. Therefore, SUST 250 should not be used during lactation.

Fertility:

In men treatment with androgens can lead to fertility disorders by repressing sperm-formation

In women treatment with androgens can lead to an infrequent or repressed menstrual cycle

Effects on ability to drive and use machines

SUST 250 has no influence on the ability to drive and use machines.

Undesirable effects

Due to the nature of SUST 250 side effects cannot be quickly reversed by discontinuing medication. Injectables in general, may cause a local reaction at the injection site.

The following adverse reactions have been associated with androgen therapy in general.

All adverse reactions are listed by system organ class and frequency; common (≥ 1/100 to < 1/10) and not known (cannot be estimated from the available data).

Treatment in women:

Treatment with SUST 250 my induce signs of virilisation in women. Symptoms of virilisation may include hoarseness, acne, hirsutism, menstrual irregularity and alopecia.

Paediatric population:

The following undesirable effects have been reported in prepubertal children using androgens: precocious sexual development, an increased frequency of erections, phallic enlargement and premature epiphyseal closure.

Overdose

The acute toxicity of testosterone is low.

If symptoms of chronic overdose occur (e.g. polycythaemia, priapism) treatment should be discontinued and after disappearance of the symptoms, be resumed at lower dosage.

Pharmacodynamic properties

Pharmacotherapeutic group: Androgens. ATC code G03B A03

Treatment of hypogonadal men with SUST 250 results in a clinically significant rise of plasma concentrations of testosterone, dihydrotestosterone, estradiol and androstenedione, as well as decrease of SHBG (Sex hormone binding globulin). Luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are restored to the normal range. In hypogonadal men, treatment with SUST 250 results in an improvement of testosterone deficiency symptoms. Moreover, treatment increases bone mineral density and lean body mass, and decreases body fat mass. Treatment also improves sexual function, including libido and erectile function. Treatment decreases serum LDL-C, HDL-C and triglycerides and increases haemoglobin and haematocrit, which may lead to polycythaemia. No clinically relevant changes in liver enzymes and PSA have been reported. Testosterone also produces systemic effects, such as increasing the retention of sodium, potassium and chloride leading to an increase in water retention. Treatment may result in an increase in prostate size, and worsening of lower urinary tract symptoms, but no adverse effects on prostate symptoms have been observed. In hypogonadal diabeteic patients, improvement of insulinsensitivity and/or reduction in blood glucose have been reported with the use of androgens. In boys with constitutional delay of growth and puberty, treatment with SUST 250 accelerates growth and induces development of secondary sex characteristics. In female-to-male transsexuals, treatment with SUST 250 induces masculinisation.

Pharmacokinetic properties

SUST 250 contains four esters of testosterone with different durations of action. The esters are hydrolysed into the natural hormone testosterone as soon as they enter the general circulation.

Absorption:

A single dose of SUST 250 leads to an increase of total plasma testosterone with peak levels of approximately 70nmol/l (Cmax), which are reached approximately 24-48 h (tmax) after administration. Plasma testosterone levels return to the lower limit of the normal range in males in approximately 21 days.

In female-to-male transsexuals, a single dose of SUST 250 repeated every two weeks resulted in mean trough testosterone levels towards the upper end of the normal male range at 2, 4 and 12 months.

Distribution:

Testosterone displays a high (over 97%) non-specific binding to plasma proteins and sex hormone binding globulin in in vitro tests.

Biotransformation:

Testosterone is metabolised to dihydrotestosterone and estradiol, which are further metabolised via the normal pathways.

Elimination:

Excretion mainly takes place via the urine as conjugates of etiocholanolone and androsterone.

Preclinical safety data

Preclinical data with androgens in general reveal no hazard for humans. The use of androgens in different species has been demonstrated to result in virilisation of the external genitals of female foetuses.

DECA 200 (10 ml/200 mg of nandrolone decanoate in ml)

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Therapeutic indications

For use in osteoporosis in post-menopausal women

Established osteoporosis should have been diagnosed by the following parameters:

i) crush or wedge fractures of the vertebrae

ii) other osteoporotic fractures

iii) established reduction in bone mineral content as measured by accepted BMC measurements.

Posology and method of administration

Posology:

Post-menopausal women

50mg every three weeks

The duration of treatment depends on the clinical response and the possible occurrence of side-effects.

We would recommend that the effectiveness of therapy be monitored with the appropriate methods for osteoporosis on a 6-12 monthly basis.

Method of administration:

DECA 200 should be administered by deep intramuscular injection

Contraindications

• Pregnancy

• Breast-feeding

• Porphyria

• Hypersensitivity to the active substance or to any of the excipients, including arachis oil. DECA 200 is therefore contraindicated in patients allergic to peanuts or soya .

Special warnings and precautions for use

Medical examination:

Physicians should consider monitoring patients receiving DECA 200 before the start of treatment, at quarterly intervals for the first 12 months and yearly thereafter for the following parameters:

• Hematocrit and hemoglobin to exclude polycythemia.

Conditions that need supervision:

Patients, especially the elderly, with the following conditions should be monitored for:

• Tumours - Mammary carcinoma, hypernephroma, bronchial carcinoma and skeletal metastases. In these patients hypercalcaemia or hypercalciuria may develop spontaneously, and also during androgen therapy. Nevertheless, the hypercalcaemia or hypercalciuria should first be treated appropriately and after restoration of normal calcium levels, if judged necessary and taking into account the risks and benefits on a case by case basis, hormone therapy can be resumed, with caution.

• Pre-existing conditions-In patients with pre-existing cardiac, renal or hepatic insufficiency/disease or epilepsy or migraine anabolic steroid treatment may cause complications characterized by oedema with or without congestive heart failure. In such cases treatment must be stopped immediately. Patients who experienced myocardial infarction, cardiac-, hepatic- or renal insufficiency, hypertension, epilepsy, or migraine should be monitored due to the risk of deterioration of or reoccurrence of disease. In such cases treatment must be stopped immediately.

• Diabetes mellitus - DECA 200 can improve glucose tolerance in diabetic patients

• Anti-coagulant therapy - DECA 200 can enhance the anti-coagulant action of coumarin-type agents

• Liver dysfunction - caution should be used in patients with severe hepatic impairment and DECA 200 200mg/ml should only be used if the benefits outweigh the risks.

Adverse events:

If anabolic steroid-associated adverse reactions occur , treatment with DECA 200 should be discontinued and, upon resolution of complaints, treatment can be resumed.

Virilisation:

If signs of virilisation develop, the risk/benefit ratio has to be newly assessed with the individual patient.

(Mis) use in sports:

Nandrolone is classified as a prohibited substance under the Olympic Movement Anti- doping Code (OMAC 1999). The misuse of Nandrolone and other anabolic steroids to enhance ability in sports carries serious health risks and is to be discouraged.

Excipients:

DECA 200 contains arachis oil (peanut oil) and should not be taken/applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid DECA 200

DECA 200 200mg/ml contains 100 mg benzyl alcohol per ml solution and must not be given to premature babies or neonates. Benzyl alcohol may cause anaphylactoid reactions in infants and children up to 3 years old.

Paediatric Population:

Safety and efficacy have not been adequately determined in children and adolescents. In pre-pubertal children statural growth and sexual development should be monitored since anabolic steroids in general and DECA 200 in high dosages may accelerate epiphyseal closure and sexual maturation.

Interaction with other medicinal products and other forms of interaction

Enzyme-inducing agents may decrease and enzyme- inhibiting drugs may increase nandrolone levels. Therefore, adjustment of the dose of DECA 200 may be required.

Insulin and other anti-diabetic medicines:

Anabolic steroids may improve glucose tolerance and decrease the need for insulin or other anti-diabetic drugs in diabetic patients. Patients with diabetes mellitus should therefore be monitored especially at the beginning or end of treatment and at periodic intervals during DECA 200 treatment.

Anti-coagulant therapy:

High doses of DECA 200 may enhance the anti-coagulant action of coumarin-type agents. Therefore close monitoring of prothrombin time and if necessary a dose reduction of the anti-coagulant is required during therapy.

ACTH or corticosteroids:

The concurrent administration of anabolic steroids with ACTH or corticosteroids may enhance edema formations; thus these active substances should be administered cautiously, particularly in patients with cardiac or hepatic disease or in patient predisposed to edema.

Laboratory test interactions:

Anabolic steroids may decrease levels of thyroxine-binding globulin resulting in decreased total T4 serum levels and increases resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Recombinant Human Erythropoietin:

Combination of DECA 200 with rhEPO (recombinant human erythropoietin), especially in females, may enable a reduction of the erythropoietin dose to reduce anemia.

Pregnancy, lactation and fertility

DECA 200 is contra-indicated in women who are pregnant

Pregnancy

There are no adequate data for the use of DECA 200 in pregnant women. In view of the risk of virilisation of the foetus, DECA 200 should not be used during pregnancy. Treatment with DECA 200 should be discontinued when pregnancy occurs.

Lactation:

There are no adequate data for the use of this medicine during lactationto assess potential harm to the infant or a possible influence on milk production. Therefore, DECA 200 should not be used during lactation.

Fertility:

In men treatment with DECA 200 can lead to fertility disorders by repressing sperm-formation. In women treatment with androgens can lead to an infrequent or repressed menstrual cycle

Effects on ability to drive and use machines

DECA 200 has no influence on the ability to drive and use machines.

Undesirable effects

Due to the nature of DECA 200 , side effects cannot be quickly reversed by discontinuing medication. Injectables in general, may cause local reaction at the injection site.

Overdose

The acute toxicity of nandrolone decanoate in animals is very low. There are no reports of acute over dosage with DECA 200 in the human

Pharmacodynamic properties

Pharmacotherapeutic group: Anabolic steroids. ATC code: A14A B01

Nandrolone is chemically related to testosterone and shows enhanced anabolic and a reduced androgenic activity.

In humans DECA 200 has been shown to positively influence calcium metabolism and to increase bone mass in osteoporosis.

Androgenic effects (e.g. virilisation) are relatively uncommon at the recommended dosages. Nandrolone lacks the C17 alpha-alkyl group which is associated with the occurrence of liver dysfunction and cholestasis.

Pharmacokinetic properties

Absorption

Nandrolone decanoate is slowly released from the injection site into the blood with a half-life of 6 days.

Distribution

The ester is rapidly hydrolysed to nandrolone in the blood with a half-life of one hour or less. The half-life for the combined process of hydrolysis of nandrolone decanoate and of distribution and elimination of nandrolone is 4.3 hours.

Biotransformation and excretion

Nandrolone is metabolised by the liver. 19-norandrosterone, 19-noretiocholanolone and 19-norepiandrosterone have been identified as metabolites in the urine. It is not known whether these metabolites display a pharmacological action.

Preclinical safety data

Toxicity studies in animals after repeated dosing did not indicate a safety risk for humans. No formal studies to assess reproduction toxicity, genotoxicity and carcinogenicity have been conducted by the company. As a class, anabolic steroids are considered to be probably carcinogenic to humans (IARC Group 2a).

The use of androgens in different species has resulted in virilisation of the external genitals of female foetuses. Investigations into the genotoxic potential of nandrolone showed it to be positive in an in vitro micronucleus assay and an in vivo micronucleus assay in mouse but not rat, and in the comet assay of mouse and rat. The clinical relevance of these findings is unknown, therefore the risk to patients cannot be ruled out.

PROP 100 (1 ml/100 mg of Testosterone Propionate in ml)

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Uses

This medication is used in men who do not make enough of a natural substance called testosterone. In males, testosterone is responsible for many normal functions, including growth and development of the genitals, muscles, and bones. It also helps cause normal sexual development (puberty) in boys. Testosterone belongs to a class of drugs known as androgens. It works by affecting many body systems so that the body can develop and function normally.

Testosterone may also be used in certain adolescent boys to cause puberty in those with delayed puberty. It may also be used to treat certain types of breast cancer in women.

How to use testosterone propionate intramuscular

This medication is given by injection into the buttock muscle as directed by your doctor, usually every 1 to 4 weeks. Do not inject this medication into a vein. Dosage is based on your medical condition, testosterone blood levels, and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Use this medication regularly in order to get the most benefit from it. To help you remember, use a calendar to mark the days you will receive an injection.

Do not suddenly stop using testosterone if you have been using it regularly for an extended time or if it has been used in high doses. In such cases, your body will no longer make its own testosterone, and withdrawal reactions (such as tiredness, weakness, depression) may occur. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

Abnormal drug-seeking behavior is possible with this medication, and it is frequently misused for its muscle-enhancing effects. Do not increase your dose, use it more frequently, or use it for a longer time than prescribed. Doing so may increase serious side effects (such as increased risk for heart disease, stroke, liver disease, ruptured tendons/ligaments, improper bone development in adolescents). Properly stop the medication when so directed.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Nausea, vomiting, headache, skin color changes, increased/decreased sexual interest, oily skin, hair loss, and acne may occur. Pain and redness at the injection site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects when it is used at normal doses.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as anxiety, depression, increased anger), trouble sleeping/snoring, signs of serious liver disease (such as persistent abdominal pain/nausea, unusual tiredness, yellowing eyes/skin, dark urine), hands/ankles/feet swelling, unusual tiredness, fast/irregular heartbeat.

Get medical help right away if you have any very serious side effects, including: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes.

If you are male, tell your doctor right away if you have any serious side effects, including: trouble urinating, breast swelling/tenderness, too frequent/prolonged erections.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.

If you are female, tell your doctor right away if you have any serious side effects, including: deepening of the voice, hoarseness, unusual facial/body hair growth, enlarged clitoris, irregular menstrual periods.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Before using testosterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as sesame oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer (such as breast cancer in men, prostate cancer), blood clots (such as in the leg, lungs), heart disease (such as heart failure, chest pain, heart attack), stroke, liver problems, kidney problems, high cholesterol, high blood pressure, enlarged prostate, sleep apnea, diabetes.

If you have diabetes, this product may decrease your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor right away if you have symptoms of low blood sugar, such as increased hunger, dizziness, or unusual sweating. Your anti-diabetic medication or diet may need to be adjusted.

This drug may affect your cholesterol and may increase your risk of heart or blood vessel problems (coronary artery disease). Your doctor will monitor your cholesterol level closely.

Tell your doctor if you become bed-ridden (unable to walk) for a prolonged time while using this medication. Your doctor may monitor your blood calcium level to prevent problems.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Caution is advised when using this drug in children because bone growth may be affected, causing shorter adult height. Your child's doctor will monitor growth and bone development during treatment.

Older adults may be more sensitive to the side effects of this drug, especially prostate/liver problems, swelling of arms/legs.

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this drug passes into breast milk. It may affect milk production and it may harm a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: "blood thinners" (such as warfarin).

This medication may interfere with certain laboratory tests (including thyroid tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share or sell this medication to others. It is against the law.

Laboratory and/or medical tests (such as blood testosterone levels, red blood cell counts, liver function tests, blood cholesterol levels, PSA test) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

TEST 250 (1 ml/250 mg of Testosterone enanthate in ml)

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Testosterone enanthate is used for:

Treating symptoms of low testosterone in men when the body does not make any testosterone or not enough testosterone (hypogonadism). It may also be used for other conditions as determined by your doctor. It is also used to treat certain types of breast cancer in women.

Testosterone enanthate is a male sex hormone. It works by replacing or supplementing the testosterone that is naturally made in the body. It also counteracts the effects of estrogen in certain types of breast cancer, which helps to decrease cancer growth

Do NOT use testosterone enanthate if:

you are allergic to any ingredient in testosterone enanthate

you are pregnant, may become pregnant, or are breast-feeding

you have breast cancer and are male; known or suspected prostate cancer; or serious heart, liver, or kidney problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using testosterone enanthate:

Some medical conditions may interact with testosterone enanthate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances (especially sesame oil)

if you have heart disease, heart failure, coronary artery disease, angina (chest pain), high cholesterol levels, swelling (edema), lung disease, or sleep apnea (long pauses in breathing while you sleep)

if you have diabetes, an enlarged prostate, kidney or liver disease, high blood calcium levels, or obesity

if you have a history of blood clots

Some MEDICINES MAY INTERACT with testosterone enanthate. Tell your health care provider if you are taking any other medicines, especially any of the following:

Carbamazepine, corticosteroids (eg, prednisone), macrolide immunosuppressants (eg, tacrolimus), or oxyphenbutazone because their actions and the risk of their side effects may be increased by testosterone enanthate

Anticoagulants (eg, warfarin), insulin, or oral hypoglycemics (eg, glyburide) because their side effects, including risk of bleeding, may be increased by testosterone enanthate

Propranolol because its effectiveness may be decreased by testosterone enanthate

This may not be a complete list of all interactions that may occur. Ask your health care provider if testosterone enanthate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use testosterone enanthate:

Use testosterone enanthate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Testosterone enanthate is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using testosterone enanthate at home, a health care provider will teach you how to use it. Be sure you understand how to use testosterone enanthate. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

Do not use testosterone enanthate if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

If you miss a dose of testosterone enanthate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use testosterone enanthate.

Important safety information:

Tell your doctor or dentist that you take testosterone enanthate before you receive any medical or dental care, emergency care, or surgery.

Testosterone enanthate is not approved for treating low testosterone levels caused by aging. Discuss any questions or concerns with your doctor.

Blood clots have happened in patients using testosterone products such as testosterone enanthate. Tell your doctor if you have ever had a blood clot. Call your doctor right away if you have symptoms of a blood clot (eg, swelling, warmth, numbness, change of color, or pain in a leg or arm; chest pain; shortness of breath; coughing up blood).

Testosterone enanthate may increase the risk of heart attack or stroke. Call your doctor right away if you have chest pain or pressure, confusion, one-sided weakness, or speech or vision problems.

Diabetes patients - Testosterone enanthate may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Testosterone enanthate may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using testosterone enanthate.

Lab tests, including liver function, blood cell counts, blood cholesterol, prostatic specific antigen, bone growth, and blood testosterone, may be performed while you use testosterone enanthate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use testosterone enanthate with caution in the ELDERLY; they may be more sensitive to its effects, especially an enlarged prostate or prostate cancer.

Testosterone enanthate should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: Do not use testosterone enanthate if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if this medicine is found in breast milk. Do not breast-feed while using testosterone enanthate.

Possible side effects of testosterone enanthate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; bitter or strange taste in mouth; change in sex drive; fatigue; gum or mouth irritation; gum pain; gum tenderness or swelling; hair loss; headache.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast growth or pain; change in the size or shape of the testicles; changes in menstrual periods; coughing fit; dark urine or light-colored bowel movements; depression or mood changes; dizziness; facial hair growth; gingivitis; interrupted breathing while sleeping; loss of appetite; nausea; painful or prolonged erection; shortness of breath; stomach pain; swelling of the ankles or legs; urination problems; voice changes or hoarseness; weight gain; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Incidence not known:

Pain, redness, or swelling in the arm or leg

trouble breathing

If any of the following symptoms of overdose occur while taking testosterone, get emergency help immediately:

Symptoms of overdose:

Blurred vision

headache

seizures

slurred speech

sudden and severe inability to speak

temporary blindness

weakness in the arm or leg on one side of the body, sudden and severe

Severity: Minor

Some testosterone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:

Gum or mouth irritation

Less common:

Bad, unusual, or unpleasant (after) taste

bleeding gums

blemishes on the skin

breast pain

change in taste

cough

crying

depersonalization

diarrhea

discouragement

dizziness

dry mouth

dysphoria

enlarged breasts

euphoria

fear or nervousness

feeling sad or empty

gum pain or blisters

hoarseness

indigestion

irritability

itching skin

loss of appetite

loss of interest or pleasure

lower back or side pain

mouth ulcers

nausea

noisy breathing

painful or difficult urination

paranoia

passing of gas

pounding in the ears

quick to react or overreact emotionally

rapidly changing moods

redness and swelling of the gums

slow or fast heartbeat

stinging of the lips

stomach cramps, pain, fullness, or discomfort

swelling of the gums

swelling of the nose

tiredness

toothache

trouble concentrating

trouble sleeping

unusual tiredness or weakness

vomiting

WINS 50 (1 ml/50 mg of Stanozolol in ml)

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WINS 50 Pregnancy Warnings

WINS 50 has been assigned to pregnancy category X. The use of WINS 50 is considered contraindicated during pregnancy. Anabolic steroid use, particularly during the first trimester of pregnancy, may cause virilization of the external genitalia of the female fetus. Reversible oligospermia may occur after prolonged administration or excessive dosage. If this effect occurs, the anabolic steroid can be discontinued and if restarted, a lower dosage should be utilized.

WINS 50 Breastfeeding Warnings

There are no data on the excretion of anabolic steroids into human milk. Because many drugs are excreted into human milk and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the woman.

Side Effects

Cardiovascular

Cardiovascular effects may be precipitated in patients adversely affected by fluid retention. Edema, with and without congestive heart failure, has occurred during anabolic steroid therapy.

Genitourinary

Genitourinary effect following chronic administration and/or large dosages of anabolic steroids can result in oligospermia and decreased ejaculatory volume. Elderly male patients may experience prostatic enlargement resulting in urinary obstruction. Priapism and excessive stimulation may develop.

In female patients the use of anabolic steroids may result in virilization including deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities. Discontinuation of medication at signs of mild virilization may prevent irreversible virilization.

Alterations in libido may occur (increased/decreased).

Hepatic

Life-threatening peliosis hepatis and hepatic abnormalities including hepatic neoplasms and hepatocellular carcinomas have occurred following prolonged therapy with high doses of anabolic steroids. Tumor regression did not occur in all cases following medication withdrawal.

Cholestatic hepatitis, jaundice, and abnormal liver function tests occur at relatively low doses.

Other

In female patients the use of anabolic steroids has resulted in virilization including deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities. Discontinuation of WINS 50 at signs of mild virilization may prevent irreversible virilization.

Musculoskeletal

Androgenic activity associated with anabolic steroids is involved in termination of linear bone growth by closure of the epiphyseal growth centers. Appropriate monitoring of bone age is recommended during WINS 50 use in prepubertal patients.

Oncologic

Oncologic effects following prolonged therapy with large doses of anabolic steroids have included hepatic neoplasms and hepatocellular carcinomas.

Hematologic

Hematologic effects occurring during anabolic steroid therapy include alteration in clotting factors II, V, VII and X , prolonged prothrombin time (PT), and increased red cell production.[Ref]

Endocrine

During exogenous administration of anabolic steroids, endogenous testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). Large doses of exogenous anabolic steroids may suppress spermatogenesis through inhibition of pituitary follicle stimulating hormone (FSH).

Decreased glucose tolerance requiring adjustments in hyperglycemic control has occurred in diabetic patients during anabolic steroid therapy.

Metabolic

Metabolic effects occurring during anabolic steroid therapy in immobilized patients or those with metastatic breast disease include osteolytic-induced hypercalcemia.

Anabolic steroids effect electrolyte balance, nitrogen retention, and urinary calcium excretion. Edema, with and without congestive heart failure, has occurred during anabolic steroid therapy.

The androgenic activity of anabolic steroids may decrease levels of thyroxin-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Significant increases in low density lipoproteins (LDL) and decreases in high density lipoproteins (HDL) have occurred.

Renal

Anabolic steroids cause retention of nitrogen, sodium, potassium, chloride, water and phosphorus, and decrease urinary excretion of calcium. Patients should be instructed to report edema.

Gastrointestinal

Gastrointestinal effects occurring during WINS 50 therapy include nausea and vomiting.

OXA-10 (100 tab/10 mg of Oxandrolone in tablet)

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Oxandrolone is used for:

Promoting weight gain, in combination with other medicines, after weight loss due to major surgery, recurring infections, serious injury, or unknown reasons. It is also used to offset certain side effects of long-term steroid use (protein catabolism), or to relieve bone pain due to osteoarthritis. It may also be used for other conditions as determined by your doctor.

Oxandrolone is an anabolic steroid. It works by helping the body to produce testosterone, which helps build muscle mass.

Do NOT use oxandrolone if:

you are allergic to any ingredient in oxandrolone

you are a man who has known or suspected breast or prostate cancer

you are a woman who has breast cancer and high blood calcium levels

you are pregnant

you have certain kidney problems (nephrosis) or high blood calcium levels

Contact your doctor or health care provider right away if any of these apply to you.

Before using oxandrolone:

Some medical conditions may interact with oxandrolone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are planning to become pregnant or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have an enlarged prostate; heart, blood vessel, kidney, or liver disease; or breast cancer

Some MEDICINES MAY INTERACT with oxandrolone. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin), carbamazepine, or diabetes medicines (eg, glipizide) because the actions and side effects of these medicines may be increased

Corticosteroids (eg, prednisone) or corticotropin because risk of serious side effects, including swelling, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if oxandrolone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use oxandrolone:

Use oxandrolone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Oxandrolone may be taken with or without food.

If you miss a dose of oxandrolone, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use oxandrolone.

Important safety information:

Oxandrolone has not been shown to enhance athletic ability. Do not take oxandrolone for any reason other than that for which it was prescribed.

Oxandrolone may reduce the number of certain clot-forming substances in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.

Diabetes patients - Oxandrolone may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.

LAB TESTS, including liver function tests, blood cell counts, cholesterol levels, or blood calcium levels, may be performed to check for side effects. Be sure to keep all doctor and lab appointments.

Use oxandrolone with caution in the ELDERLY because they may be more sensitive to its effects, especially prostate problems (eg, enlargement, cancer), fluid buildup, or abnormal liver function tests.

Use oxandrolone with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.

Oxandrolone may affect the bone growth rate in CHILDREN. Your child's bone growth should be checked every 6 months while using oxandrolone.

PREGNANCY and BREAST-FEEDING: Do not use oxandrolone if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if oxandrolone is excreted in breast milk. Do not breast-feed while taking oxandrolone.

When used for long periods of time or at high doses, some people develop a need to continue taking oxandrolone. This is known as DEPENDENCE or addiction.

If you suddenly stop taking oxandrolone, you may experience WITHDRAWAL symptoms, including depression, insomnia, loss of appetite, mood swings, reduced sex drive, restlessness, or tiredness.

Possible side effects of oxandrolone:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Difficulty sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne; changes in sexual desire; changes in skin color; confusion; dark urine; deepening of the voice, unusual hair growth (especially facial hair), or hoarseness; depression; easy bruising or bleeding; enlarged genitals or breasts; excitability; frequent or persistent erections; increased urination or thirst; irregular heartbeat; loss of appetite; menstrual irregularities; mental or mood changes; muscle cramps or twitching; nausea or vomiting; stomach pain; swelling of the ankles or hands; unusual tiredness; yellowing of the skin or eyes.

Side Effects

Cardiovascular

Cardiovascular side effects have included edema, with and without congestive heart failure.

Genitourinary

Genitourinary side effects following chronic administration and/or large dosages of anabolic steroids have included oligospermia and decreased ejaculatory volume. Elderly male patients may experience prostatic enlargement resulting in urinary obstruction. Priapism and excessive stimulation may develop. Female patients may experience virilization including deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities. Discontinuation of anabolic steroids at signs of mild virilization may prevent irreversible virilization. Alterations in libido may occur (increased/decreased).

Hepatic

Hepatic side effects have included life-threatening peliosis hepatitis and hepatic abnormalities, such as hepatic neoplasms and hepatocellular carcinomas, following prolonged therapy with high doses of anabolic steroids. Tumor regression did not occur in all cases following medication withdrawal. Cholestatic hepatitis, jaundice, and abnormal liver function tests can occur at relatively low dosages.

Hepatic tumors associated with anabolic steroid use are more vascular than other hepatic tumors and may remain silent until the development of life-threatening abdominal hemorrhage. Peliosis hepatitis may present as mild liver dysfunction, but has resulted in liver failure.

Other

Other side effects have included virilization of female patients including deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities. Discontinuation of anabolic steroids at signs of mild virilization may prevent irreversible virilization

Musculoskeletal

Musculoskeletal effects have included termination of linear bone growth due to closure of the epiphyseal growth centers. Appropriate monitoring of bone age is recommended during use in prepubertal patients.

Hematologic

Hematologic side effects have included alterations in clotting factors II, V, VII and X, prolonged prothrombin time (PT), and increased red cell production.

Endocrine

Endocrine side effects have included inhibition of endogenous testosterone release by means of feedback inhibition of pituitary luteinizing hormone (LH). Large doses of exogenous anabolic steroids may suppress spermatogenesis through inhibition of pituitary follicle stimulating hormone (FSH). The androgenic activity of anabolic steroids may decrease levels of thyroxin-binding globulin and result in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged and there is no clinical evidence of thyroid dysfunction.

Metabolic

Metabolic side effects have included osteolytic-induced hypercalcemia in immobilized patients or those with metastatic breast disease. Anabolic steroids affect electrolyte balance, nitrogen retention, and urinary calcium excretion. Edema, with and without congestive heart failure, has occurred during anabolic steroid therapy. Decreased glucose tolerance requiring adjustments in hyperglycemic control has been noted in diabetic patients. The androgenic activity of anabolic steroids may decrease levels of thyroxin-binding globulin and result in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged and there is no clinical evidence of thyroid dysfunction. Significant increases in low density lipoproteins (LDL) and decreases in high density lipoproteins (HDL) have occurred.

Renal

Renal side effects have included retention of nitrogen, sodium, potassium, chloride, water and phosphorus, and decreased urinary excretion of calcium.

Oncologic

Oncologic side effects have included hepatic neoplasms and hepatocellular carcinomas following prolonged therapy with large doses of anabolic steroids.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, and diarrhea.

Psychiatric

Psychiatric side effects have included habituation, excitation, insomnia, depression, and libido changes.

Dermatologic

Dermatologic side effects have included acne and changes in skin color. The greatest incidence of occurrence has been in women and prepubertal males.

Dosage

Usual Adult Dose for Weight Loss

To promote weight gain following weight loss associated with extensive surgery, chronic infections, or severe trauma, and in select patients who fail to gain or maintain normal weight. It is indicated to counter chronic corticosteroid-induced protein catabolism, and for relief of bone pain associated with osteoporosis.

2.5 to 10 mg orally 2 to 4 times daily. Dose range: 2.5 to 20 mg per day.

Usual Adult Dose for Alcoholic Liver Damage

2.5 to 10 mg orally 2 to 4 times daily. Dose range: 2.5 to 20 mg per day.

Usual Geriatric Dose for Weight Loss

5 mg orally 2 times daily. Dose range: 2.5 to 20 mg per day.

Usual Pediatric Dose for Turner's Syndrome

Maximum dose: 0.1 mg/kg/day orally.

Oxandrolone Pregnancy Warnings

Oxandrolone has been assigned to pregnancy category X by the FDA. Anabolic steroid use, particularly during the first trimester of pregnancy, may cause virilization of the external genitalia of the female fetus. Reversible oligospermia may occur after prolonged administration or excessive dosage in male patients. There are no controlled data in human pregnancy. Oxandrolone use is considered contraindicated during pregnancy.

If reversible oligospermia occurs, the anabolic steroid can be discontinued and if restarted, a lower dosage should be utilized.

Oxandrolone Breastfeeding Warnings

There are no data on the excretion of anabolic steroids into human milk. The manufacturer recommends that due to the potential for adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

OXY-50 (100 tab/50 mg of oxymetholone in tablet)

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Oxymetholone is an anabolic steroid, which is a man-made form of a hormone similar to testosterone.

Oxymetholone is used to treat certain types of anemia (lack of red blood cells), including anemia caused by chemotherapy.

Oxymetholone will not enhance athletic performance and should not be used for that purpose.

Oxymetholone may also be used for purposes not listed in this medication guide.

important information:

You should not use this medicine if you have severe liver or kidney disease, prostate cancer, male breast cancer, or female breast cancer with high levels of calcium in the blood.

Do not use oxymetholone if you are pregnant.

Long-term use of oxymetholone can cause liver tumors or blood-filled cysts in your liver or spleen. Call your doctor at once if you have upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), or rapid weight gain (especially in your face and midsection).

before taking oxymetholone:

You should not use oxymetholone if you are allergic to it, or if you have:

prostate cancer;

male breast cancer;

female breast cancer with high levels of calcium in the blood;

severe liver disease;

severe kidney disease; or

if you are pregnant.

To make sure oxymetholone is safe for you, tell your doctor if you have:

liver or kidney disease;

heart disease, congestive heart failure;

coronary artery disease (hardened arteries);

high cholesterol or triglycerides;

diabetes;

bleeding or blood clotting disorder;

enlarged prostate; or

if you also take a blood thinner (warfarin, Coumadin, Jantoven).

FDA pregnancy category X. This medicine can harm an unborn baby or cause birth defects. Do not use oxymetholone if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medicine.

This medicine may affect fertility (your ability to have children), whether you are a man or a woman.

It is not known whether oxymetholone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medicine to anyone under 18 years old without medical advice. A child using oxymetholone may need x-rays every 6 months to make sure this medicine is not causing harmful effects on bone growth.

Do not share this medicine with another person.

How should take oxymetholone:

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

To be sure this medicine is helping your condition, you may need frequent blood tests. You may not notice any change in your symptoms, but your blood work will help your doctor determine how long to treat you with oxymetholone.

Tell your doctor if you have any changes in weight. Oxymetholone doses are based on weight, and any changes may affect the dose.

It may take 3 to 6 months before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using oxymetholone.

Oxymetholone is only part of a treatment program that may also include blood transfusions and/or using other medicines. Follow your doctor's instructions very closely.

Once your condition is under control, you may be able to stop taking oxymetholone. Some people must continue taking a small amount of oxymetholone to keep their red blood cells from getting too low. You may need to take oxymetholone for the rest of your life. Follow your doctor's instructions.

Store at room temperature away from moisture, heat, and light.

Do not share this medicine with another person. Keep track of the amount of medicine used from each new bottle. Oxymetholone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Oxymetholone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Long-term use of oxymetholone can cause liver tumors or blood-filled cysts in your liver or spleen. Call your doctor at once if you have:

nausea, upper stomach pain;

rapid weight gain, especially in your face and midsection;

loss of appetite, dark urine, clay-colored stools; or

jaundice (yellowing of the skin or eyes).

Also call your doctor at once if you have:

painful or difficult urination;

increased interest in sex, painful or ongoing erection of the penis;

loss of interest in sex, impotence, trouble having an orgasm, decreased amount of semen when you ejaculate;

easy bruising or bleeding (nosebleeds, bleeding gums), any bleeding that will not stop;

painful swelling in your breasts;

changes in skin color; or

shortness of breath (even with mild exertion), swelling in your hands or feet.

Women receiving oxymetholone may develop male features, which could be irreversible if treatment is continued. If you are a woman taking oxymetholone, tell your doctor right away if you have:

hoarse or deepened voice;

increased facial hair, hair growth on the chest;

male pattern baldness;

enlarged clitoris;

changes in your menstrual periods; or

increased or decreased interest in sex.

Common side effects in both men and women may include:

acne;

male pattern baldness;

breast swelling or tenderness (in men or women);

feeling restless or excited;

sleep problems (insomnia); or

nausea, vomiting, diarrhea.

Cardiovascular

Cardiovascular side effects have included fluid retention. Edema, with and without congestive heart failure, has occurred during anabolic steroid therapy.[Ref]

Genitourinary

Genitourinary effects have included oligospermia and decreased ejaculatory volume. Elderly male patients may experience prostatic enlargement resulting in urinary obstruction. Priapism and excessive stimulation may develop. Female patients may experience virilization, including deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities. Discontinuation of anabolic steroids at signs of mild virilization may prevent irreversible virilization. Alterations in libido may occur (increased/decreased).[Ref]

Hepatic

Hepatic side effects have included life-threatening peliosis hepatitis and hepatic abnormalities such as hepatic neoplasms and hepatocellular carcinomas following prolonged therapy with high doses of anabolic steroids. Tumor regression did not occur in all cases following medication withdrawal. Cholestatic hepatitis, jaundice, and abnormal liver function tests can occur at relatively low dosages.[Ref]

Other

Other side effects have included female patients experiencing virilization including deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities. Discontinuation of anabolic steroids at signs of mild virilization may prevent irreversible virilization.[Ref]

Musculoskeletal

Musculoskeletal side effects have included closure of the epiphyseal growth centers by termination of linear bone growth. Appropriate monitoring of bone age is recommended during use in prepubertal patients.[Ref]

Oncologic

Oncologic side effects have included hepatic neoplasms and hepatocellular carcinomas following prolonged therapy with large doses of anabolic steroids[Ref]

Hematologic

Hematologic side effects have included alterations in clotting factors II, V, VII and X , prolonged prothrombin time (PT), and increased red cell production. Leukemia has been reported rarely during oxymetholone therapy in patients with aplastic anemia. A causal relationship has not been established and leukemia has been observed in patients with aplastic anemia who were not treated with oxymetholone.[Ref]

Endocrine

Metabolic

Renal

Renal side effects have included retention of nitrogen, sodium, potassium, chloride, water and phosphorus, and decreased urinary excretion of calcium.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, and diarrhea.[Ref]

Psychiatric

Psychiatric side effects have included habituation, excitation, insomnia, depression, and libido changes.[Ref]

Dermatologic

Dermatologic side effects have frequently included acne. The greatest incidence of occurrence has been in women and prepubertal males.[Ref]

Oxymetholone dosing information

Usual Adult Dose for Anemia:

Anemias caused by deficient red cell production:

1 to 5 mg/kg/day orally. Usual effective dose is 1 to 2 mg/kg/day. Response is often not immediate. Give for a minimum trial of 3 to 6 months.

Usual Pediatric Dose for Anemia:

Anemias caused by deficient red cell production:

1 to 5 mg/kg/day orally. Usual effective dose is 1 to 2 mg/kg/day. Response is often not immediate. Give for a minimum trial of 3 to 6 months.

What other drugs will affect oxymetholone?

Other drugs may interact with oxymetholone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

MET-OXY 15 (100 tab/15 mg in tablet: Methyltestosterone-5 mg, Oxymetholone-10 mg)

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Description of the pharmacological action:

Once inside the cell nucleus, activates the genetic apparatus of cells leading to increased synthesis of DNA, RNA and structural proteins, activates enzymes of tissue respiration chain and enhancing tissue respiration, oxidative phosphorylation, ATP synthesis and accumulation of makroergs inside the cell. Stimulates anabolic and inhibits catabolic processes induced by glucocorticoids. Leads to increase muscle mass, reduce fat and negative nitrogen balance. Hematopoietic effect due to the increased synthesis of erythropoietin. Anti-allergic effect caused by increasing concentrations of C1 fraction of complement inhibitor and the decrease in the content of C2 and C4 fractions of complement. Androgenic activity (moderate) may contribute to the development of secondary sexual characteristics of male type.

Indications for use:

Cachexia, impaired protein metabolism (after severe injuries, operations, burns, radiation therapy); severe infectious diseases accompanied by loss of protein; progressive muscular dystrophy, myopathy glucocorticoidinduced; diabetic angiopathy; the need to accelerate regeneration of fractures, trauma; slowing growth children (syndrome Shereshevsky-Turner, pituitary dwarfism), delayed puberty (sexual infantilism) and physical development in boys; encephalopathy on the background of alcoholic hepatitis.

Pharmacokinetics:

Rapidly and completely absorbed from the gastrointestinal tract, low bioavailability due to the effect of "first passage" through the liver. In the blood with specific globulins-carriers associated 90%. Final undergoes biotransformation in the liver to form inactive metabolites. Excreted by the kidneys. The duration of up to 14 h

Use during pregnancy:

Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Contraindications:

Hypersensitivity, breast cancer (in men), breast cancer, hepatic and/or renal insufficiency, prostate adenoma, hypercalcaemia, nephrosis, glomerulonephritis (nephrotic stage).

Side effects:

From the digestive tract: diarrhoeal phenomenon (nausea, vomiting, diarrhea, abdominal pain), abnormal liver function, jaundice.

Cardio-vascular system and blood (hematopoiesis, hemostasis): hypocoagulation state with bleeding tendency, leukemoid syndrome (leukemia, pain in the long tubular bones), iron deficiency anemia.

Other: the progression of atherosclerosis (increase concentrations of LDL and decreased concentration of HDL), and peripheral edema.

With long-term therapy — gepatonekros (dark feces, vomiting with blood, headache, discomfort, respiratory failure), hepatocellular carcinoma, hepatic purpura (dark urine, stool discoloration, urticaria, petechial or maloletnye hemorrhagic rash on the skin and mucous membranes, pharyngitis or tonsillitis), cholestatic hepatitis (yellow staining skler and skin, pain in the right hypochondrium, dark urine, discolored feces), increased secretion of the sebaceous glands, chills, increased or decreased libido, diarrhea, feeling of fullness of stomach, flatulence, cramps, sleep disturbance. In women: virilization (clitoral enlargement, roughness or hoarseness, DYS - or amenorrhea, hirsutism, steroid acne, oily skin), hypercalcemia (CNS depression, nausea, vomiting, fatigue).

Men: in prepubertal period are manifestations of excessive androgen activity (acne, penis enlargement, priapism, formation of secondary sexual characteristics), idiopathic hyperpigmentation of the skin, slowing or stopping the growth (calcification of epiphyseal growth zones tubular bones); during the period postpubertatne — bladder irritation (increased frequency of urination), mastodynia, gynecomastia, priapism, decreased sexual function; older hyperplasia and/or carcinoma of the prostate.

Method of application and doses:

Inside, the food. Adults — 5 mg 1-2 times per day. The highest dose of 50 mg/day. Children: under 2 years — 0.05–0.1 mg/kg; from 2 to 5 years — 1-2 mg, from 6 to 14 years — 3-5 mg in 1-2 reception. Course — up to 4 weeks. Second course — after 6-8 weeks.

Interaction with other drugs:

Enhances the action of anticoagulants, antiplatelet agents, and hypoglycemic agents, as well as side effects gepatotoksikal drugs.

Special instructions when taking:

In the course of treatment requires systematic monitoring blood concentration of Ca2+ (especially in patients with breast cancer and in the presence of metastases in bone), cholesterol (especially in patients with concomitant pathology SSS), glucose (patients with diabetes), hematocrit, Hb, serum phosphorus concentration, as well as the functional state of the liver. In the course of treatment should be ensured adequate intake of adequate amounts of proteins, fats, carbohydrates, vitamins, minerals. If you experience menstrual irregularities and/or signs of virilization treatment should be discontinued. Suppress lactation. The use of anabolic steroids in order to stimulate athletic qualities can cause serious harm to health and is unacceptable. To monitor the status of the epiphyseal growth zones tubular bones in children and adolescents it is recommended that x-ray examination every 6 months. It should be borne in mind that the use of steroid use of anabolic steroids in elderly patients may contribute to the development of prostatic hyperplasia. The feasibility of using steroid anabolics in osteoporosis is unclear (unproven effectiveness and high risk of serious side effects).

CYP 200 (1 ml/200 mg of Testosterone cypionate in ml)

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Description:

Testosterone Cypionate Injection, for intramuscular injection, contains Testosterone Cypionate, which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone Testosterone.

Testosterone Cypionate, a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils.

The chemical name for Testosterone Cypionate, androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61.

Clinical Pharmacology:

Endogenous androgens are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the prostate, seminal vesicles, penis, and scrotum; development of male hair distribution, such as beard, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, and alterations in body musculature and fat distribution. Drugs in this class also cause retention of nitrogen, sodium, potassium, and phosphorus, and decreased urinary excretion of calcium. Androgens have been reported to increase protein anabolism and decrease protein catabolism. Nitrogen balance is improved only when there is sufficient intake of calories and protein.

Androgens are responsible for the growth spurt of adolescence and for eventual termination of linear growth, brought about by fusion of the epiphyseal growth centers. In children, exogenous androgens accelerate linear growth rates, but may cause disproportionate advancement in bone maturation. Use over long periods may result in fusion of the epiphyseal growth centers and termination of the growth process. Androgens have been reported to stimulate production of red blood cells by enhancing production of erythropoietic stimulation factor.

During exogenous administration of androgens, endogenous Testosterone release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). At large doses of exogenous androgens, spermatogenesis may also be suppressed through feedback inhibition of pituitary follicle stimulating hormone (FSH).

There is a lack of substantial evidence that androgens are effective in fractures, surgery, convalescence, and functional uterine bleeding.

Pharmacokinetics:

Testosterone esters are less polar than free Testosterone. Testosterone esters in oil injected intramuscularly are absorbed slowly from the lipid phase; thus, Testosterone cypionate can be given at intervals of two to four weeks.

Testosterone in plasma is 98 percent bound to a specific Testosterone-estradiol binding globulin, and about 2 percent is free. Generally, the amount of this sex-hormone binding globulin in the plasma will determine the distribution of Testosterone between free and bound forms, and the free Testosterone concentration will determine its half-life.

About 90 percent of a dose of Testosterone is excreted in the urine as glucuronic and sulfuric acid conjugates of Testosterone and its metabolites; about 6 percent of a dose is excreted in the feces, mostly in the unconjugated form. Inactivation of Testosterone occurs primarily in the liver. Testosterone is metabolized to various 17-keto steroids through two different pathways.

The half-life of Testosterone cypionate when injected intramuscularly is approximately eight days.

In many tissues the activity of Testosterone appears to depend on reduction to dihydroTestosterone, which binds to cytosol receptor proteins. The steroid-receptor complex is transported to the nucleus where it initiates transcription events and cellular changes related to androgen action.

Indications and Usage for Testosterone:

Testosterone Cypionate Injection, indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous Testosterone.

Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.

Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.

Safety and efficacy of Testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

Contraindications:

Known hypersensitivity to the drug

Males with carcinoma of the breast

Males with known or suspected carcinoma of the prostate gland

Women who are or who may become pregnant

Patients with serious cardiac, hepatic or renal disease

Warnings:

Hypercalcemia may occur in immobilized patients. If this occurs, the drug should be discontinued.

Prolonged use of high doses of androgens (principally the 17-α alkyl-androgens) has been associated with development of hepatic adenomas, hepatocellular carcinoma, and peliosis hepatis - all potentially life-threatening complications.

Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.

There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using Testosterone products, such as Testosterone cypionate. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with Testosterone cypionate and initiate appropriate workup and management.

Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of Testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of Testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of Testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use Testosterone cypionate.

Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease.

Gynecomastia may develop and occasionally persists in patients being treated for hypogonadism.

The preservative benzyl alcohol has been associated with serious adverse events, including the “gasping syndrome”, and death in pediatric patients. Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity depends on the quantity administered and the hepatic capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity..

Androgen therapy should be used cautiously in healthy males with delayed puberty. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height.

This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.

Precautions:

General

Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. Oligospermia may occur after prolonged administration or excessive dosage. If any of these effects appear, the androgen should be stopped and if restarted, a lower dosage should be utilized.

Testosterone cypionate should not be used interchangeably with Testosterone propionate because of differences in duration of action.

Testosterone cypionate is not for intravenous use.

Information for patients:

Patients should be instructed to report any of the following: nausea, vomiting, changes in skin color, ankle swelling, too frequent or persistent erections of the penis.

Laboratory tests:

Hemoglobin and hematocrit levels (to detect polycythemia) should be checked periodically in patients receiving long-term androgen administration.

Serum cholesterol may increase during androgen therapy.

Drug interactions:

Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia.

Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.

In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

Drug/Laboratory test Interferences:

Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Carcinogenesis:

Animal data

Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of Testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.

Human data

There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.

Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.

Pregnancy

Teratogenic Effects

Pregnancy Category X (See CONTRAINDICATIONS).

Benzyl alcohol can cross the placenta. See WARNINGS.

Nursing mothers

Testosterone cypionate injection is not recommended for use in nursing mothers.

Pediatric use

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Adverse Reactions

The following adverse reactions in the male have occurred with some androgens:

Endocrine and urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages.

Skin and appendages: Hirsutism, male pattern of baldness, seborrhea, and acne.

Cardiovascular Disorders: Myocardial infarction, stroke

Fluid and electrolyte disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.

Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (see WARNINGS).

Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.

Nervous system: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.

Allergic: Hypersensitivity, including skin manifestations and anaphylactoid reactions.

Vascular Disorders: Venous thromboembolism.

Miscellaneous: Inflammation and pain at the site of intramuscular injection.

Drug Abuse and Dependence

Controlled Substance Class

Testosterone is a controlled substance under the Anabolic Steroids Control Act, and Testosterone cypionate injection has been assigned to Schedule III.

Overdosage

There have been no reports of acute overdosage with the androgens.

Testosterone Dosage and Administration

Prior to initiating Testosterone cypionate, confirm the diagnosis of hypogonadism by ensuring that serum Testosterone concentrations have been measured in the morning on at least two separate days and that these serum Testosterone concentrations are below the normal range.

Testosterone cypionate injection is for intramuscular use only.

It should not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle.

The suggested dosage for Testosterone cypionate injection varies depending on the age, sex, and diagnosis of the individual patient. Dosage is adjusted according to the patient's response and the appearance of adverse reactions.

Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses, with or without a decrease to maintenance levels. Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose.

For replacement in the hypogonadal male, 50 to 400 mg should be administered every two to four weeks.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.

DECA 100 (10 ml/100 mg of nandrolone phenylpropionate in ml)

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Therapeutic indications

For use in osteoporosis in post-menopausal women

Established osteoporosis should have been diagnosed by the following parameters:

i) crush or wedge fractures of the vertebrae

ii) other osteoporotic fractures

iii) established reduction in bone mineral content as measured by accepted BMC measurements.

Posology and method of administration

Posology:

Post-menopausal women

50mg every three weeks

The duration of treatment depends on the clinical response and the possible occurrence of side-effects.

We would recommend that the effectiveness of therapy be monitored with the appropriate methods for osteoporosis on a 6-12 monthly basis.

Method of administration:

DECA 100 should be administered by deep intramuscular injection

Contraindications

• Pregnancy

• Breast-feeding

• Porphyria

• Hypersensitivity to the active substance or to any of the excipients, including arachis oil. DECA 100 is therefore contraindicated in patients allergic to peanuts or soya .

Special warnings and precautions for use

Medical examination:

Physicians should consider monitoring patients receiving DECA 100 before the start of treatment, at quarterly intervals for the first 12 months and yearly thereafter for the following parameters:

• Hematocrit and hemoglobin to exclude polycythemia.

Conditions that need supervision:

Patients, especially the elderly, with the following conditions should be monitored for:

• Tumours - Mammary carcinoma, hypernephroma, bronchial carcinoma and skeletal metastases. In these patients hypercalcaemia or hypercalciuria may develop spontaneously, and also during androgen therapy. Nevertheless, the hypercalcaemia or hypercalciuria should first be treated appropriately and after restoration of normal calcium levels, if judged necessary and taking into account the risks and benefits on a case by case basis, hormone therapy can be resumed, with caution.

• Diabetes mellitus - DECA 100 can improve glucose tolerance in diabetic patients

• Anti-coagulant therapy - DECA 100 can enhance the anti-coagulant action of coumarin-type agents

• Liver dysfunction - caution should be used in patients with severe hepatic impairment and DECA 100 100mg/ml should only be used if the benefits outweigh the risks.

Adverse events:

If anabolic steroid-associated adverse reactions occur , treatment with DECA 100 should be discontinued and, upon resolution of complaints, treatment can be resumed.

Virilisation:

If signs of virilisation develop, the risk/benefit ratio has to be newly assessed with the individual patient.

(Mis) use in sports:

Excipients:

DECA 100 contains arachis oil (peanut oil) and should not be taken/applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid DECA 100

DECA 100 100mg/ml contains 100 mg benzyl alcohol per ml solution and must not be given to premature babies or neonates. Benzyl alcohol may cause anaphylactoid reactions in infants and children up to 3 years old.

Paediatric Population:

Safety and efficacy have not been adequately determined in children and adolescents. In pre-pubertal children statural growth and sexual development should be monitored since anabolic steroids in general and DECA 100 in high dosages may accelerate epiphyseal closure and sexual maturation.

Interaction with other medicinal products and other forms of interaction

Enzyme-inducing agents may decrease and enzyme- inhibiting drugs may increase nandrolone levels. Therefore, adjustment of the dose of DECA 100 may be required.

Insulin and other anti-diabetic medicines:

Anti-coagulant therapy:

High doses of DECA 100 may enhance the anti-coagulant action of coumarin-type agents. Therefore close monitoring of prothrombin time and if necessary a dose reduction of the anti-coagulant is required during therapy.

ACTH or corticosteroids:

Laboratory test interactions:

Recombinant Human Erythropoietin:

Combination of DECA 100 with rhEPO (recombinant human erythropoietin), especially in females, may enable a reduction of the erythropoietin dose to reduce anemia.

Pregnancy, lactation and fertility

DECA 100 is contra-indicated in women who are pregnant

Pregnancy

There are no adequate data for the use of DECA 100 in pregnant women. In view of the risk of virilisation of the foetus, DECA 100 should not be used during pregnancy. Treatment with DECA 100 should be discontinued when pregnancy occurs.

Lactation:

There are no adequate data for the use of this medicine during lactationto assess potential harm to the infant or a possible influence on milk production. Therefore, DECA 100 should not be used during lactation.

Fertility:

In men treatment with DECA 100 can lead to fertility disorders by repressing sperm-formation. In women treatment with androgens can lead to an infrequent or repressed menstrual cycle

Effects on ability to drive and use machines

DECA 100 has no influence on the ability to drive and use machines.

Undesirable effects

Due to the nature of DECA 100, side effects cannot be quickly reversed by discontinuing medication. Injectables in general, may cause local reaction at the injection site.

Overdose

The acute toxicity of nandrolone decanoate in animals is very low. There are no reports of acute over dosage with DECA 100 in the human

Pharmacodynamic properties

Pharmacotherapeutic group: Anabolic steroids. ATC code: A14A B01

Nandrolone is chemically related to testosterone and shows enhanced anabolic and a reduced androgenic activity.

In humans DECA 100 has been shown to positively influence calcium metabolism and to increase bone mass in osteoporosis.

Pharmacokinetic properties

Absorption

Nandrolone phenylpropionate is slowly released from the injection site into the blood with a half-life of 1 day.

Distribution

The ester is rapidly hydrolysed to nandrolone in the blood with a half-life of one hour or less. The half-life for the combined process of hydrolysis of nandrolone phenylpropionate and of distribution and elimination of nandrolone is 4.3 hours.

Biotransformation and excretion

Preclinical safety data

STAN-10 (100 tab/10 mg of Stanozolol in tablet)

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STAN-10 Pregnancy Warnings

STAN-10 has been assigned to pregnancy category X. The use of STAN-10 is considered contraindicated during pregnancy. Anabolic steroid use, particularly during the first trimester of pregnancy, may cause virilization of the external genitalia of the female fetus. Reversible oligospermia may occur after prolonged administration or excessive dosage. If this effect occurs, the anabolic steroid can be discontinued and if restarted, a lower dosage should be utilized.

STAN 10 Breastfeeding Warnings

Side Effects

Cardiovascular

Cardiovascular effects may be precipitated in patients adversely affected by fluid retention. Edema, with and without congestive heart failure, has occurred during anabolic steroid therapy.

Genitourinary

Alterations in libido may occur (increased/decreased).

Hepatic

Cholestatic hepatitis, jaundice, and abnormal liver function tests occur at relatively low doses.

Other

In female patients the use of anabolic steroids has resulted in virilization including deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities. Discontinuation of STAN-10 at signs of mild virilization may prevent irreversible virilization.

Musculoskeletal

Oncologic

Oncologic effects following prolonged therapy with large doses of anabolic steroids have included hepatic neoplasms and hepatocellular carcinomas.

Hematologic

Hematologic effects occurring during anabolic steroid therapy include alteration in clotting factors II, V, VII and X , prolonged prothrombin time (PT), and increased red cell production.

Endocrine

Decreased glucose tolerance requiring adjustments in hyperglycemic control has occurred in diabetic patients during anabolic steroid therapy.

Metabolic

Metabolic effects occurring during anabolic steroid therapy in immobilized patients or those with metastatic breast disease include osteolytic-induced hypercalcemia.

Anabolic steroids effect electrolyte balance, nitrogen retention, and urinary calcium excretion. Edema, with and without congestive heart failure, has occurred during anabolic steroid therapy.

Significant increases in low density lipoproteins (LDL) and decreases in high density lipoproteins (HDL) have occurred.

Renal

Anabolic steroids cause retention of nitrogen, sodium, potassium, chloride, water and phosphorus, and decrease urinary excretion of calcium. Patients should be instructed to report edema.

Gastrointestinal

Gastrointestinal effects occurring during STAN-10 therapy include nausea and vomiting.

TUR-10 (100 tab/10 mg of chlorodehydromethyltestosterone in tablet)

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Description of the pharmacological action:

Indications for use:

Pharmacokinetics:

Use during pregnancy:

Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Contraindications:

Hypersensitivity, breast cancer (in men), breast cancer, hepatic and/or renal insufficiency, prostate adenoma, hypercalcaemia, nephrosis, glomerulonephritis (nephrotic stage).

Side effects:

[1] Estrogenic:

The side effects of Oral Turinabol do not include any of an estrogenic nature. This steroid does not aromatize and carries no progestin related traits making side effects like gynecomastia and excess water retention impossible. This should also greatly reduce the risk of high blood pressure as high blood pressure due to steroid use is most commonly linked to severe water retention.

[2] Androgenic:

On a structural basis TUR-10 appears to carry no androgenic activity but the total information we have at our disposal is inconclusive. As the steroid is no longer manufactured legitimately and probably never will be again, more than likely its androgenic nature may always remain a slight mystery. However, we do know that it displays very little androgenic activity but we cannot say as some have attempted to say that it doesn’t posses any. Androgenic side effects of Oral Turinabol are possible, although unlikely. Such side effects may include acne, accelerated hair loss in those predisposed to male pattern baldness and body hair growth. Such effects will be highly dependent on genetics but the androgenic effects will not be affected by inhibitors. 5-alpha reductase inhibitors will have little effect on this steroid’s androgenicity as it is not significantly metabolized by the 5-alpha reductase enzyme.

[3] Cardiovascular:

TUR-10 can have a significant impact on cholesterol in increasing LDL levels (bad cholesterol) and suppressing/reducing HDL levels (good cholesterol). This negative effect on cholesterol will carry a stronger probability than with just about any injectable steroid you could use. Further, while we wouldn’t necessarily call it the unfriendliest oral steroid in this category it is far from the friendliest.

[4] Testosterone:

TUR-10 is suppressive to natural testosterone and should be used in conjunction with exogenous testosterone. Men who use TUR-10 without exogenous testosterone will risk a low testosterone condition. Such a condition can come with a host of possible symptoms ranging from physical, mental and sexually related. However, while physical related symptoms are unlikely when steroids are being used the others are a very real possibility

[5] Hepatotoxic:

As a C17-aa anabolic steroid, TUR-10 is hepatotoxic. Liver enzyme values will increase with use due to the stress it will place on the liver. However, it’s important to remember an increase in enzyme values does not automatically equate to damage, but it is an indicator of stress. This is not the most hepatotoxic C17-aa steroid at our disposal but it is far from the mildest. With proper use it is more than possible to avoid any liver damage, but this will require responsible use.

Method of application and doses:

Interaction with other drugs:

Enhances the action of anticoagulants, antiplatelet agents, and hypoglycemic agents, as well as side effects gepatotoksikal drugs.

Special instructions when taking:

PRIMO 100 (10 ml/100 mg of methenolone enanthate in ml)

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Name: PRIMO 100

Pharmacological action:

Boosts physical activity and appetite, increase body mass, stimulates the synthesis of endogenous (produced in the body) protein, improves the General condition, reduces the secretion of urea.

Indications for use:

To increase physical activity and appetite, increasing body weight, after heavy operations and serious chronic infectious diseases; cachexia (extreme exhaustion), status after radiation and cytostatic (means it suppresses cell division in cancerous tumors) therapy, breast cancer and genital organs in women, disorders of blood formation (hematopoiesis), long-term treatment with corticosteroids, osteoporosis (eating disorders bone accompanied by the increase in its friability), slow formation of callus, chronic hepatitis, cirrhosis, muscular dystrophy (volume reduction and strength of muscles), impaired growth and development of children.

Method of application:

Designate adults and 1 ml intramuscularly 1 every 2 weeks, then 1 ml 1 every 3 weeks, children - 1 mg/kg of body weight, 1 time in 14 days, which corresponds to 0.07 mg/kg of body weight per day.

Contraindications:

Pregnancy, prostate cancer.

Form of issue: bottle volume 10 ml, with a concentration of 100 mg/ml

Storage conditions:

In a dry, protected from light.

Pharmacological group:

Medicinal products used in diseases of the gastrointestinal tract

Drugs different groups

Attention!

Before purchasing or using the medication you should consult with your doctor.

Information about the drug provided solely for informational purposes and should not be used as a guide to self-healing. Only a doctor can make the decision on the appointment of the drug, and to determine the doses and methods of application.

MAST 100 (1 ml/100 mg of drostanolone propionate in ml)

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Name: MAST 100

Pharmacological action:

Boosts physical activity and appetite, increase body mass, stimulates the synthesis of endogenous (produced in the body) protein, improves the General condition, reduces the secretion of urea.

Indications for use:

Method of application:

Designate adults and 1 ml intramuscularly 1 every 1 weeks, then 1 ml 1 every 2 weeks, children - 1 mg/kg of body weight, 1 time in 10 days, which corresponds to 0.07 mg/kg of body weight per day.

Contraindications:

Pregnancy, prostate cancer.

Form of issue: bottle volume 1 ml, with a concentration of 100 mg/ml

Storage conditions:

In a dry, protected from light.

Pharmacological group:

Medicinal products used in diseases of the gastrointestinal tract

Drugs different groups

Attention!

Before purchasing or using the medication you should consult with your doctor.

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