Virormone Injection

Each ampoule contains testosterone propionate BP, 100mg in 2ml.

For excipients, see section 6.1 (list of excipients).

Solution for Injection.

In the male

Replacement therapy in castrated adults and in those who are hypogonadal due to either pituitary or testicular disease.

In the female

Control of carcinoma of the breast in post-menopausal women.

In the male

Hypogonadism 50mg 2-3 time weekly

Delayed puberty and cryptorchidism 50mg weekly

In the female

Carcinoma of the breast 100mg 2-3 times weekly.

Intramuscular use.

Breast cancer in men.

Prostatic carcinoma.

Pregnancy.

Breast feeding.

Nephrosis.

History of primary liver tumours.

Hypercalcaemia or hypercalciuria.

Known hypersensitivity to any of the ingredients.

Tumours of the liver have been reported (rarely) in patients subjected to prolonged treatment with high doses of androgenic-anabolic steroids. The possibility that these compounds may induce or enhance the development of hepatic tumours cannot at present be excluded and this should be considered when the use of this product is proposed, especially in young people who are not suffering with life threatening disorders.

Do not use before puberty in males, unless for treatment of delayed puberty. In any case caution is advised since the fusion of the epiphyses is hastened and may lead to short stature or precocious sexual development.

Use with care in patients with cardiac, renal or hepatic impairment, circulatory failure, hypertension, epilepsy, diabetes mellitus, skeletal metastases (risk of hypercalcaemia) or a history of migraine. A reduced dosage may be advised in elderly male patients since hyperstimulation can occur.

In male patients, regular examination of the prostate should be undertaken.

High dose or long term administration of testosterone occasionally increases tendency to water retention and oedema. Caution should be exercised in patients predisposed to oedema.

Virilism may occur in female patients on high doses.

Androgens may interfere with a number of clinical laboratory tests such as those for glucose tolerance and thyroid function.

Testosterone may enhance the effect of anti-coagulants (warfarin, acenocoumarol and phenindione).

The hypoglycaemic effect of anti-diabetics may be enhanced by testosterone.

Plasma levels of testosterone may be affected by enzyme-inducing agents with possible impairment of efficacy.

Testosterone is contraindicated in pregnancy and lactation.

None known.

The following adverse events have been reported in association with testosterone therapy:-

Signs of virilisation (acne, hirsutism, voice changes, male pattern baldness).

Precocious sexual development in pre-pubertal boys, increased frequency and duration of erections, premature closure of the epiphyses.

Suppression of spermatogenesis. Priapism, changes in libido and other signs of excessive sexual stimulation.

Electrolyte disturbances including sodium retention with oedema and hypercalceamia.

Headache, depression, gastro-intestinal disturbances, gynaecomastia, anxiety, asthenia, generalised paraesthesia and increased bone growth.

Rarely prostatic abnormalities and hepatic tumours.

Acute toxicity of intramuscular testosterone is very low. In the event of inadvertent administration of multiple doses, no acute toxicity risk is to be anticipated.

The hormone testosterone and its derivatives have anabolic and androgenic properties.

Testosterone Propionate when injected intramuscularly in oil is absorbed more slowly than the free steroid and is therefore more active.

Testosterone is about 80% bound to sex-hormone binding globulin. It is largely metabolised in the liver by oxidation; the metabolites are excreted in urine mainly as glucuronides and sulphates. About 6% is excreted unchanged in the faeces after undergoing enterohepatic recirculation.

None stated.

Ethyl oleate BP

None stated

60 months

Protect from light. Store in the original container.

Each pack contains 10 x 2ml clear glass type I ampoules. Each ampoule contains a sterile pale yellow solution of Testosterone Propionate BP in ethyl oleate (100mg/2ml)

Not applicable.

Nordic Pharma Limited

Abbey House

1650 Arlington Business Park

Theale

Reading

RG7 4SA

United Kingdom

PL 05827/0014

1^st October 2002

August 2003