Testosterone Compound Injection 250mg Taj Pharma

Testosterone Compound Injection 250mg Taj Pharma

1. Name of the medicinal product

Testosterone Compound Injection 250mg, 250mg/ml solution for injection

2.Qualitative and quantitative composition

Testosterone Compound Injection 250mg is a solution in oil.

Each ampoule contains:

1 ml arachis oil containing the following active substances:

Testosterone propionate              30mg

Testosterone phenylpropionate   60mg

Testosterone isocaproate             60 mg

Testosterone decanoate               100 mg

Excipients                                    q.s.

All four components are esters of the natural hormone testosterone. The total amount of testosterone per ml is 176 mg.

For the full list of excipients, see section 6.1.

3.Pharmaceutical form

Solution for injection

A clear, pale yellow solution

4.Clinical particulars

4.1 Therapeutic indications

Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.

Testosterone administration may also be used as supportive therapy for female-to-male transsexuals.

4.2 Posology and method of administration

Posology

In general, the dose should be adjusted to the response of the individual patient.

Adults (incl. elderly):

Usually, one injection of 1ml per 3 weeks is adequate.

Paediatric population

Safety and efficacy have not been adequately determined in children and adolescents. Pre-pubertal children treated with Testosterone Compound Injection 250mg should be treated with caution (see section 4.4).

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

Testosterone Compound Injection 250mg should be administered by deep intramuscular injection.

4.3 Contraindications

• Pregnancy (see section 4.6).
• Known or suspected carcinoma of the prostate or breast (see section 4.4.).
• Breast-feeding.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, including arachis oil. Testosterone Compound Injection 250mg is therefore contraindicated in patients allergic to peanuts or soya (see section 4.4).

4.4 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 Testosterone Compound Injection 250mg 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 (see section 4.3),
• 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 Testosterone Compound Injection 250mg 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 Testosterone Compound Injection 250mg can improve glucose tolerance in diabetic patients (see section 4.5).
• Anti-coagulant therapy – Androgens in general and Testosterone Compound Injection 250mg can enhance the anti-coagulant action of coumarin-type agents (see also section 4.5).
• 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 (see section 4.8), treatment with Testosterone Compound Injection 250mg 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 Testosterone Compound Injection 250mg can interfere with anti-doping testing. The misuse of androgens to enhance ability in sports carries serious health risks and is to be discouraged.

Drug abuse and dependence:

Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication(s) and in combination with other anabolic androgenic steroids. Abuse of testosterone and other anabolic androgenic steroids can lead to serious adverse reactions including: cardiovascular (with fatal outcomes in some cases), hepatic and/or psychiatric events. Testosterone abuse may result in dependence and withdrawal symptoms upon significant dose reduction or abrupt discontinuation of use. The abuse of testosterone and other anabolic androgenic steroids carries serious health risks and is to be discouraged.

Excipients:

Testosterone Compound Injection 250mg 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 Testosterone Compound Injection 250mg (see section 4.3).

Testosterone Compound Injection 250mg 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 Testosterone Compound Injection 250mg 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 Testosterone Compound Injection 250mg 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 Testosterone Compound Injection 250mg 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.

Clotting disorders:

Testosterone should be used with caution in patients with thrombophilia, as there have been post-marketing studies and reports of thrombotic events in these patients during testosterone therapy.

4.5 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 Testosterone Compound Injection 250mg 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 (see section 4.4).

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

Anti-coagulant therapy:

High doses of androgens may enhance the anticoagulant action of coumarin type agents (see section 4.4). 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 (see section 4.4).

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.

4.6 Fertility, pregnancy and lactation

Testosterone Compound Injection 250mg is contra-indicated in women who are pregnant (see section 4.3).

Pregnancy

There are no adequate data for the use of Testosterone Compound Injection 250mg in pregnant women. In view of the risk of virilisation of the foetus, Testosterone Compound Injection 250mg should not be used during pregnancy (see section 4.3). Treatment with Sustanon should be discontinued when pregnancy occurs.

Breastfeeding

There are no adequate data for the use of Testosterone Compound Injection 250mg during lactation. Therefore, Testosterone Compound Injection 250mg should not be used during lactation.

Fertility

In men treatment with androgens can lead to fertility disorders by repressing sperm-formation (see section 4.8).

In women treatment with androgens can lead to an infrequent or repressed menstrual cycle (see section 4.8).

4.7 Effects on ability to drive and use machines

Testosterone Compound Injection 250mg has no influence on the ability to drive and use machines.

4.8 Undesirable effects

Due to the nature of Testosterone Compound Injection 250mg 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).

The terms used to describe the undesirable effects above are also meant to include synonyms and related terms.

Treatment in women

Treatment with Testosterone Compound Injection 250mg may induce signs of virilisation in women (see section 4.4). 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 (see section 4.4): precocious sexual development, an increased frequency of erections, phallic enlargement and premature epiphyseal closure.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 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.

5.Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Androgens.

Treatment of hypogonadal men with Testosterone Compound Injection 250mg 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 Testosterone Compound Injection 250mg 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 insulin sensitivity 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 Testosterone Compound Injection 250mg accelerates growth and induces development of secondary sex characteristics. In female-to-male transsexuals, treatment with Testosterone Compound Injection 250mg induces masculinisation.

5.2 Pharmacokinetic properties

Testosterone Compound Injection 250mg 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 Testosterone Compound Injection 250mg 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 Testosterone Compound Injection 250mg 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.

5.3 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.

6.Pharmaceutical particulars

6.1 List of excipients

Arachis Oil

Benzyl Alcohol

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store below 30°C

Do not refrigerate or freeze

Store in the original package in order to protect from light

6.5 Nature and contents of container

Each colourless glass ampoule is filled with 1 ml of Testosterone Compound Injection 250mg.

A box of Testosterone Compound Injection 250mg contains 1 ampoule. Not all pack sizes may be marketed. In correspondence please quote batch number.

6.6 Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Testosterone Compound Injection 250mg Taj Pharma

(testosterone esters)

Package Leaflet: Information for the patient

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Testosterone Compound Injection 250mg is and what it is used for
2. What you need to know before Testosterone Compound Injection 250mg is administered
3. How Testosterone Compound Injection 250mg is administered
4. Possible side effects
5. How to store Testosterone compound Injection 250
6. Contents of the pack and other Information

1.What is Testosterone Compound Injection 250mg  is and what it is used for

Testosterone Compound Injection 250mg is a clear paleyellow solution for injection containing the active ingredient testosterone in 4 (250 mg/ml) separate forms. The active substances of Testosterone Compound Injection 250mg (see section 6 “What Testosterone Compound Injection 250mg contains”) are turned into testosterone by your body. Testosterone is a natural male hormone known as an androgen.

In men, testosterone is produced by the testicles. It is necessary for the normal growth, development and function of the male sex organs and for secondary male sex characteristics. It is necessary for the growth of body hair, the development of bones and muscles, and it stimulates the production of red blood cells. It also makes men’s voices deepen.

Testosterone Compound Injection 250mg is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism). This should be confirmed by two separate blood testosterone measurements and also include clinical symptoms such as impotence, infertility, low sex drive, tiredness, depressive moods and bone loss caused by low hormone levels.

Testosterone Compound Injection 250mg may also be used as supportive therapy for female-to-male transsexuals.

2.What you need to know before Testosterone Compound Injection 250mg  is administered

 Do not take Testosterone Compound Injection 250mg:

• If you are pregnant or think you may be pregnant (see “Pregnancy, breast-feeding and fertility”).
• If you have or have had a tumour of your prostate or breast, or are suspected to have one of these tumours.
• In children under the age of 3 years.
• If you are allergic to testosterone or to any of the other ingredients of this medicine (listed in section 6)
• If you are allergic to peanuts or soya (see Section 2 “Important information about some of the ingredients of Testosterone Compound Injection 250mg “).

Warnings and precautions

If you notice any signs of masculinisation (for instance lowering of the voice or increase in body or facial hair), consult your doctor immediately.

Treatment with male hormones like testosterone may increase the size of the prostate gland, especially in elderly men. Therefore your doctor will examine your prostate gland at regular intervals by digital rectal examination (DRE) and blood tests for prostate-specific antigen (PSA).

Additionally, at regular intervals, blood tests will be done to check the oxygen-carrying substance in your red blood cells (haemoglobin). In very rare cases the number of red blood cells will increase too much leading to complications.

The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count.

Medical checks may also be necessary in some other conditions.

Talk to your doctor or pharmacist before you start using this medicine if you ever had, still have or are suspected to have:

• Breast cancer which has spread to the bones;
• Kidney or lung cancer;
• Heart disease;
• Kidney disease;
• Liver disease;
• High blood pressure;
• Diabetes mellitus;
• Epilepsy;
• Migraine, headaches;
• Prostatic complaints, such as problems with passing urine;
• Blood clotting problems – thrombophilia (an abnormality of blood coagulation that increases the risk of thrombosis – blood clots in blood vessels).

If you are suffering from severe heart, liver or kidney disease, treatment with Testosterone Compound Injection 250mg  may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure.

Tell your doctor if you have high blood pressure or if you are treated for high blood pressure as testosterone may cause a rise in blood pressure.

If you have sleep apnoea (temporarily stopping breathing during your sleep), it may get worse if you are using testosterone-containing products. Let your doctor know if you are worried about this. Extra supervision by your doctor may be necessary in case you are overweight or suffer from chronic lung disease.

During treatment you should also tell your doctor:

• if you are a female-to-male transsexual. You should have special assessments, including psychiatric assessment, before treatment is started.
• if you are a female-to-male transsexual and have a personal or family history of breast cancer and a personal history of endometrial

Children and adolescents

The safety and efficacy of this medicine has not been adequately determined in children and adolescents. Extra supervision by your doctor is necessary in the treatment of children and adolescents since testosterone administration in general may cause early sexual development and limits growth (see section 4 “Children and adolescents”).

Blood tests may be affected.

For female-to-male transsexuals, Testosterone Compound Injection 250mg may be given as part of a programme of treatment, including surgery.

Other medicines and Testosterone Compound Injection 250mg

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines – even those not prescribed.

Other medicines may influence the effects of Testosterone Compound Injection 250mg, or Testosterone Compound Injection 250mg may affect other medicines. Therefore, you must tell your doctor or pharmacist if you are using, or are about to use:

• Insulin and/or other medicines to control blood sugar levels;
• Medicines to reduce the clotting of your blood (anti-coagulants);
• Certain medicines that change the amount of enzymes to be made in the liver e.g. medicines used to treat epilepsy (phenobarbital).

These drugs may affect the levels of testosterone in your body and your doctor may need to adjust the dose or frequency of your Testosterone Compound Injection 250mg.

The use of androgens like Testosterone Compound Injection 250mg may lead to a reduction of the doses of these medicines.

Tell your doctor or pharmacist if you are using or about to use the hormone ACTH or corticosteroids (used to treat various conditions such as rheumatism, arthritis, allergic conditions and asthma). The use of androgens like Testosterone Compound Injection 250mg may increase the risk of water retention especially if your heart and liver are not working properly.

Androgens may also affect the results of some laboratory tests (e.g. thyroid gland). Therefore, you must tell your doctor or the laboratory staff performing the tests that you are using this medicine.

Testosterone Compound Injection 250mg with food and drink

This medicine can be injected without taking consideration of meals and drinks.

Pregnancy, breast-feeding and fertility

Testosterone Compound Injection 250mg must not be taken by women who are pregnant or think they are pregnant (see section 2 “Do not use Testosterone Compound Injection 250mg”), or by women who are breast-feeding.

In men, treatment with Testosterone Compound Injection 250mg can lead to fertility disorders by repressing sperm formation. In women, treatment with this medicine can lead to an irregular or absent menstrual cycle.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

As far as is known this medicine has no influence on driving and using machines.

Testosterone Compound Injection 250mg contains Arachis oil (peanut oil) and Benzyl alcohol
This medicine also contains:

• Arachis oil (peanut oil) – If you are allergic to peanut or soya, do not use this medicinal product (see “Do not use Sustanon 250”).
• Benzyl alcohol (100 mg per ml of solution) – Products containing benzyl alcohol must not be given to premature babies or neonates. Benzyl alcohol may cause toxic reactions and allergic reactions in infants and children up to 3 years

Improper use

If you are a patient who participates in competitions governed by the World Anti-Doping Agency (WADA), then you should consult the WADA-code before using this medicine as Testosterone Compound Injection 250mg can interfere with anti-doping testing.

The misuse of this medicine to enhance ability in sports carries serious health risks and is discouraged.

Drug abuse and dependence

This medicine should only be given by a doctor or nurse and used exactly as your doctor has told you. Abuse of testosterone, especially if you use too much of this medicine alone or with other anabolic androgenic steroids, can cause serious health problems to your heart and blood vessels (that can lead to death), mental health and/or the liver. Individuals who have abused testosterone may become dependent and experience withdrawal symptoms when the dosage changes significantly or is stopped immediately. You should not abuse this medicine alone or with other anabolic androgenic steroids because it carries serious health risks.

3. How Testosterone Compound Injection 250mg  is administered

This medicine should only be given by a doctor or a nurse. The injections are given deeply into a muscle (for instance in the buttock, upper leg or upper arm). The dose depends on your illness and how bad it is. Your doctor will decide the dose.

Usually, the dosage is one injection of 1 ml every three weeks.

If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or nurse immediately.

Use in children and adolescents

The safety and efficacy of this medicine have not been adequately determined in children and adolescents.

Pre-pubertal children using this medicine will be monitored by your doctor (see section 2 “Take special care with Testosterone Compound Injection 250mg”).

If you use more Testosterone Compound Injection 250mg than you should

Your doctor or nurse will inject this medicine into you. If you have the impression that the effect of this medicine is too strong then please talk to your doctor or nurse immediately.

The following effects may happen:

• Frequent erections in men;
• Changes in your red blood cells (polycythaemia), which your doctor may monitor you

If you forgot to get your injection of Testosterone Compound Injection 250mg

Your doctor or nurse will inject this medicine into you. Should you miss a scheduled injection then please talk to your doctor or nurse as soon as possible. No double dose should be injected to make up for forgotten individual doses.

If you stop treatment with Testosterone Compound Injection 250mg

The effects of this medicine do not stop immediately after discontinuation, but gradually subside.

When treatment with this medicine is stopped, complaints such as those experienced before treatment may re-occur within a few weeks.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Adults (female-to-male transsexuals)

Testosterone Compound Injection 250mg:

Doses vary from one injection of 1 ml every two weeks to one injection of 1 ml every four weeks.

4. Possible side effects

Like all medicines, this medicine can cause side effects although not everybody gets them. In general, the side effects which are reported with testosterone therapy include:

Common (may affect up to 1 in 10 people)

• Increase in red blood cell count (the cells which carry the oxygen in your blood); haematocrit (percentage of red blood cells in blood) and haemoglobin (the component of red blood cells that carries oxygen), identified by periodic blood

Not known (cannot be estimated from available data)

• Itching (pruritus);
• Acne;
• Nausea;
• Changes in liver function tests;
• Changes in cholesterol levels (changes in lipid metabolism);
• Depression, nervousness, mood alterations;
• Muscle pain (myalgia);
• Fluid retention in the tissues, usually marked by swelling of ankles or feet;
• High blood pressure (hypertension);
• Changes in sexual desire;
• Prolonged abnormal, painful erection of the penis;
• Ejaculation disorder;
• Disturbed formation of sperm;
• Feminisation (gynaecomastia);
• Prostatic growth to a size representative for the concerned age group;
• Increased levels of a blood marker which is associated with prostate cancer (PSA increased);
• Increased growth of a small prostate cancer which has not been detected yet (progression of a sub- clinical prostatic cancer).

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

Side effects in women:

In women, this product may induce signs of masculinisation (for example, lowering of the voice, and increase in body or facial hair.)

Children and adolescents:

The following side effects have been reported in pre-pubertal children using androgens:

• Early sexual development;
• Penis enlargement;
• An increased frequency of erections;
• Growth limitation (limited body height)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5.How to store Testosterone Compound Injection 250mg

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton or label after the term “exp” (expiry date). The expiry date refers to the last day of that month.

Store below 30°C. Do not refrigerate or freeze.

Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your Pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.Contents of the pack and other information What Testosterone Compound Injection 250mg  contains

Testosterone Compound Injection 250mg is a solution in oil.

Each ampoule contains:

1 ml arachis oil containing the following active substances:

Testosterone propionate              30mg

Testosterone phenylpropionate   60mg

Testosterone isocaproate             60 mg

Testosterone decanoate               100 mg

Excipients                                    q.s.

All four components are esters of the natural hormone testosterone. The total amount of testosterone per ml is 176 mg.

The other ingredients are:

The solution for injection contains Arachis oil and Benzyl Alcohol.

What Testosterone Compound Injection 250mg  looks like and contents of the pack

Testosterone Compound Injection 250mg  is a clear, pale yellow solution for deep intramuscular injection. Each colourless glass ampoule is filled with 1 ml of Testosterone Compound Injection 250mg

A box of Testosterone Compound Injection 250mg contains 1 ampoule. Not all pack sizes are marketed.

If you have any further questions or require the full prescribing information for this medicine please consult your doctor or pharmacist.

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com