SUSTANON Solution for injection Ref.[28068] Active ingredients: Testosterone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: ASPEN PHARMA TRADING LIMITED, 3016 LAKE DRIVE, CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND

4.1. Therapeutic indications

Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.

Testosterone administration may also be used as supportive therapy for female-to-male transsexuals.

4.2. Posology and method of administration

Posology

In general, the dose should be adjusted to the response of the individual patient.

Adults (incl. elderly)

Usually, one injection of 1ml per 3 weeks is adequate.

Paediatric population

Safety and efficacy have not been adequately determined in children and adolescents. Pre-pubertal children treated with Sustanon 250 should be treated with caution (see section 4.4).

Female-to-male transsexuals

Different specialist centres have used doses varying from one injection of 1ml every two weeks to one injection of 1ml every four weeks.

Method of administration

Sustanon 250 should be administered by deep intramuscular injection.

4.9. Overdose

The acute toxicity of testosterone is low.

If symptoms of chronic overdose occur (e.g. polycythaemia, priapism) treatment should be discontinued and after disappearance of the symptoms, be resumed at lower dosage.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 30°C

Do not refrigerate or freeze.

Store in the original package in order to protect from light.

6.5. Nature and contents of container

Each colourless glass ampoule is filled with 1 ml of Sustanon 250.

A box of Sustanon 250 contains 1 ampoule. Not all pack sizes may be marketed. In correspondence please quote batch number.

6.6. Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

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