SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Testosterone Propionate 100 mg/2 ml Solution for Injection Virormone (100 mg/2 ml)

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient

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

3    PHARMACEUTICAL FORM

Injection. Ampoules containing a sterile pale yellow solution of Testosterone Propionate in ethyloleate.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

In the male

Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests. It is used as a replacement therapy in castrated adults and in those who are hypogonadal due to either pituitary or testicular disease.

In the female

May also be used for control of carcinoma of the breast in post-menopausal women.

4.2    Posology and method of administration

In the male

Hypogonadism 50 mg 2-3 times weekly.

Delayed puberty and cryptorchidism 50 mg weekly.

In the female

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

By intramuscular injection.

Safety and efficacy have not been adequately determined in children and adolescents.

4.3    Contraindications

Breast cancer in men, prostatic carcinoma, pregnancy, breast feeding and nephrosis.

4.4    Special warnings and precautions for use

Tumours of the liver have been reported occasionally in patients subjected to prolonged treatment with 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.

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 case, treatment must be stopped immediately.

Testosterone may cause a rise in blood pressure and testosterone propionate solution for injection should be used with caution in men with hypertension.

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.

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.

There is limited experience on the safety and efficacy of the use of testosterone propionate solution for injection 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.

A reduced dosage may be advised in elderly male patients since hyperstimulation can occur.

Use with care in patients with circulatory failure or epilepsy.

Virilism may occur in female patients on high doses.

4.5    Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Fertility, Pregnancy and lactation

Contraindicated.

4.7 Effects on ability to drive and use machines

None stated.

4.8    Undesirable effects

The frequencies of adverse events are ranked according to the following: Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100, rare (>1/10,000, <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Common: Haematocrit increased, Red blood cell count increased, Haemoglobin increased

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 of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9    Overdose

None stated.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Androgen

5.2 Pharmacokinetic properties

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

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethyl oleate BP.

6.2 Incompatibilities

None stated.