Intervet UK Limited

Durateston

Presentation

An oily solution for injection. Each ml of the solution contains:

6 mg Testosterone Propionate PhEur.

12 mg Testosterone Phenylpropionate BP.

12 mg Testosterone Isocaproate BP.

20 mg Testosterone Decanoate BP.

The product contains 104 mg/ml Benzyl Alcohol PhEur as the preservative.

Uses

Testosterone is the naturally occurring androgenic hormone. The basic effects of testosterone can be summarised as follows:

• stimulation of the development of the secondary male sexual characteristics (anatomical and behavioural).
• anti-oestrogenic activity.
• negative feedback activity on gonadotrophin release from the pituitary gland.

By means of a controlled release of testosterone from the injection site Durateston is designed to provide androgenic activity over a period of up to 28 days following a single injection.

Androgen therapy has been found to be effective for the following specific indications:

• reversion of feminisation in male dogs (e.g. due to Sertoli cell tumours).
• suppression of oestrus in the bitch (particularly in racing greyhounds in which progestagen treatment can reduce performance).
• treatment of pseudopregnancy in the bitch.
• treatment of certain skin conditions in the dog and cat (e.g. endocrine alopecia alopecia due to hypogonadism in male dogs and senile alopecia in male dogs).

Dosage and administration

As with all physiological hormone therapies there can be considerable variation in response to treatment; the above dosage may need to be adjusted according to clinical response but should not exceed 2 ml/10 kg. For sustained androgen therapy treatment should be repeated every 28 days. Continuation of treatment beyond 6 months would indicate a need for reassessment of the animal's condition.

Administer by subcutaneous or intramuscular injection observing the usual aseptic precautions.

To measure small volumes of less than 1 ml a suitably graduated syringe should be used to ensure accurate administration of the correct dose.

Contra-indications warnings etc

1. Durateston should not be given to animals with cardiac insufficiency or a prior history of liver or kidney disease as medication may be associated with sodium and water retention.
2. Do not use in pregnant animals since female puppies may develop urinogenital abnormalities in utero.
3. Do not administer to dogs with prostate hypertrophy or with androgen dependent neoplastic conditions.
4. In cases of hypogonadism Durateston should only be used to control associated alopecia.
5. Undesirable virilisation such as clitoral enlargement and a low grade vaginitis can occur from overdosage in certain individuals (see under `Further information').
6. Use of Durateston in male cats may cause spraying of urine.

For animal treatment only. Keep out of reach of children.

Pharmaceutical precautions

Store below 25°C. Protect from light.

At low temperatures the product may become viscous. Warming the vial in the hand will return the contents to the normal state.

Following withdrawal of the first dose use the product within 28 days. Discard unused material safely. Avoid the introduction of contamination during use.

Swab the septum before removing each dose. Use a dry sterile needle and syringe.

Unused product should be disposed of in accordance with appropriate waste regulation authority guidelines.

Legal category

POM.

Package quantities

5 ml vial.

Further information

Should unwanted virilisation occur medication should be discontinued until symptoms regress. A reduced dosage may then be introduced.

The administration of androgens to prepubertal animals may result in early epiphyseal closure.

Marketing authorisation number

Vm 01708/4262.