NEBIDO Solution

SOLUTION, STERILE

**4.2 Dosage and method of administration** **_Method of administration_** Solution for injection _**Dosage regimen**_ Nebido (1 ampoule / vial 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. The injections must be administered very slowly. 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 given to avoid intravasal injection. The contents of an ampoule or vial are to be injected intramuscularly immediately after opening. See section “Instructions for use/ handling” to avoid injury when opening – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. - _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 individualization 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 level may be considered. _**Additional information on special populations**_ _Paediatric patients_ 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 “Special warnings and precautions for use” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Geriatric patients_ Limited data do not suggest the need for a dosage adjustment in elderly patients (see section “Special warnings and precautions for use” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _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 “Contraindications”). _Patients with renal impairment_ No formal studies have been performed in patients with renal impairment.