Durateston solution for injection

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Durateston solution for injection Data Sheet

Presentation

A sterile, oily solution for injection. Each ml of the solution contains:

Testosterone Propionate 6 mg

Testosterone Phenylpropionate 12 mg

Testosterone Isocaproate 12 mg

Testosterone Decanoate 20 mg

 

The product contains 104 mg/ml Benzyl alcohol 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

Species dosage

dog and cat 0.5 - 1 ml/10 kg

 

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 intramuscular or subcutaneous injection, observing the usual aseptic precautions.

To measure small volumes of less than 1ml 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.

Warnings:

Use in pregnancy may result in virilisation of the foetus, therefore it is advisable that pregnant women avoid administering this product.

Avoid accidental self-injection of this product. Wash hands after use.

 

FOR ANIMAL TREATMENT ONLY. KEEP OUT OF REACH AND SIGHT OF CHILDREN.

 

Pharmaceutical precautions

Do not store above 25oC. 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. Avoid the introduction of contamination during use.

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

Following withdrawal of the first dose, use the product within 28 days.

When the container is broached (opened) for the first time, use the in-use shelf life which is specified on the package leaflet to calculate the date on which any remaining product should be discarded. This discard date should be written in the space provided on the label.

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

 

Legal category

 

POM-V To be supplied only on veterinary prescription.

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

 

Date of text preparation:

March 2009.