Intervet UK Limited

Orandrone

Presentation

White tablets 8 mm in diameter and

marked

zx 3

on one side. Each tablet contains 5 mg of

methyltestosterone PhEur.

Uses

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

• Stimulates the development of the secondary male sexual characteristics (anatomical and behavioural).
• Has anti-oestrogenic activity.
• Exerts a negative feedback on gonadotrophin release from the pituitary gland.
• Has anabolic effects.

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

• Treatment of deficient sex drive in male animals.
• Treatment of some cases of cryptorchidism in male dogs in which gonadotrophin therapy has failed.
• Reversion of feminisation in male dogs caused by the oestrogenic effects of testicular tumours. Orandrone can be used to antagonise these effects after the tumours have been surgically re-moved.
• Treatment of oestrogen dependent mammary tumours in the bitch. Orandrone may be used concurrently with parenteral androgen therapy.
• Suppression of oestrus in the bitch (particularly in racing greyhounds in which progestagen treatment can reduce performance).
• Treatment of pseudo pregnancy in the bitch.
• Treatment of certain skin conditions in the dog and cat (e.g. feline endocrine alopecia alopecia due to hypogonadism in male dogs and cats senile alopecia in male dogs).
• Supportive anabolic therapy (e.g. in cases of debility senile decline etc).

Dosage and administration

For oral 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 1 mg/kg.

As with therapy with other steroid hormones it may be useful to taper dose at the end of a prolonged course of therapy. This can be achieved by dosing 2 or 3 times weekly rather than daily.

Contra-indications warnings etc

Undesirable virilisation and aggression can occur from overdosage in certain individual male animals and the product may cause masculinisation in female animals.

Deficient sex drive in male animals

Doses above physiological levels may block the endogenous output of GnRH and pituitary gonadotrophin resulting in decline of endogenous testosterone output and cessation of spermatogenesis.

Cryptorchidism

Trapping of the undescended testicle in the canal sometimes occurs as a consequence of androgen therapy for this condition; and prolonged treatment of growing animals may cause stunted growth.

The product should not be given to pregnant animals and should be used with caution in bitches and queens intended for future breeding.

The product should not be given to animals suffering from liver disease or chronic congestive heart failure.

In young animals early epiphyseal closure may occur.

For animal treatment only.

Keep out of reach of children.

Pharmaceutical precautions

Store below 25°C. Protect from light. Store in a dry place.

Legal category

POM.

Package quantities

Plastic containers of 500 tablets (5 mg).

Further information

Should unwanted virilisation occur medication should be discontinued until symptoms regress. A reduced dosage may then be introduced. Perineal swelling may result from prolonged medication. If treatment is continued for more than 6 months liver function should be monitored.

Marketing authorisation number

Vm 01708/4247.