Posology : מינונים

4.2 Posology and method of administration

Posology

One vial of Nebido (corresponding to 1000 mg testosterone undecanoate) is injected every 10 to 14 weeks. Injections with this frequency are capable of maintaining sufficient testosterone levels and do not lead to accumulation.

Start of treatment

Serum testosterone levels should be measured before start and during initiation of treatment. Depending on serum testosterone levels and clinical symptoms, the first injection interval may be reduced to a minimum of 6 weeks as compared to the recommended range of 10 to 14 weeks for maintenance. With this loading dose, sufficient steady state testosterone levels may be achieved more rapidly.
Maintenance and individualisation of treatment

The injection interval should be within the recommended range of 10 to 14 weeks.
Careful monitoring of serum testosterone levels is required during maintenance of treatment. It is advisable to measure testosterone serum levels regularly. Measurements should be performed at the end of an injection interval and clinical symptoms considered.
These serum levels should be within the lower third of the normal range. Serum levels below normal range would indicate the need for a shorter injection interval. In case of high serum levels an extension of the injection interval may be considered.

Special populations

Paediatric population
Nebido is not indicated for use in children and adolescents and it has not been clinically evaluated in males under 18 years of age (see section 4.4).

Geriatric patients

Limited data do not suggest the need for a dosage adjustment in elderly patients (see section 4.4).

Patients with hepatic impairment

No formal studies have been performed in patients with hepatic impairment. The use of Nebido is contraindicated in men with past or present liver tumours (see section 4.3).

Patients with renal impairment

No formal studies have been performed in patients with renal impairment.
Method of administration
For intramuscular use.

The injections must be administered very slowly (over two minutes). Nebido is strictly for intramuscular injection. Care should be taken to inject Nebido deeply into the gluteal muscle following the usual precautions for intramuscular administration. Special care must be taken to avoid intravasal injection (see section 4.4 under “Application”). The contents of a vial are to be injected intramuscularly immediately after opening (see section 6.6 for Special precautions for disposal and other handling).