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In case of high serum levels an extension of the injection interval may be considered. 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. Limited data do not suggest the need for a dosage adjustment in elderly patients (see section 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. Patients with renal impairment. No formal studies have been performed in patients with renal impairment. 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. The contents of an ampoule / vial are to be injected intramuscularly immediately after opening. The use of Nebido is contraindicated in men with: ‘ androgen-dependent carcinoma of the prostate or of the male mammary gland. The use of Nebido in women is contraindicated. Nebido is not recommended for use in children and adolescents, bpc 157 5 mg peptides . Nebido should be used only if hypogonadism (hyper- and hypogonadotrophic) has been demonstrated and if other aetiology, responsible for the symptoms, has been excluded before treatment is started. Testosterone insufficiency should be clearly demonstrated by clinical features (regression of secondary sexual characteristics, change in body composition, asthenia, reduced libido, erectile dysfunction etc. There is limited experience on the safety and efficacy of the use of Nebido in patients over 65 years of age. Currently, there is no consensus about age specific testosterone reference values. However, it should be taken into account that physiologically testosterone serum levels are lower with increasing age. Medical examination and laboratory tests. Prior to testosterone initiation, all patients must undergo a detailed examination in order to exclude a risk of pre-existing prostatic cancer. Careful and regular monitoring of the prostate gland and breast must be performed in accordance with recommended methods (digital rectal examination and estimation of serum PSA) in patients receiving testosterone therapy at least once yearly and twice yearly in elderly patients and at risk patients (those with clinical or familial factors). Local guidelines for safety monitoring under testosterone replacement therapy should be taken into consideration.
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