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Show table of contents. Hide table of contents. Name of the medicinal product 2. Qualitative and quantitative composition 3, fempro 2.5 mg antiestrogens 34 0 femara. Marketing authorisation holder 8. Marketing authorisation number(s) 9. Date of first authorisation/renewal of the authorisation 10. Date of revision of the text. This information is intended for use by health professionals. Testosterone Enantate 250 mg/ ml Solution for Injection. Each 1ml ampoule contains 250mg Testosterone Enantate (the equivalent of about 180 mg testosterone) in oily solution. Also contains 342 mg benzyl benzoate per ampoule. For the full list of excipients, see section 6. Clear, yellowish oily solution. Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests. To stimulate development of underdeveloped androgen-dependent organs and for initial treatment of deficiency symptoms, 250mg Testosterone Enantate intramuscularly every two to three weeks. For maintenance treatment: 250mg Testosterone Enantate intramuscularly every three to six weeks, according to individual requirement. Serum testosterone levels should be measured before start of treatment and occasionally during the treatment at the end of an injection interval. 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. Testosterone Enantate is not indicated for use in children and adolescents (see 4. Safety and efficacy have not been adequately determined in children and adolescents. Limited data do not suggest the need for a dosage adjustment in elderly patients (see 4. Patients with hepatic impairment. No formal studies have been performed in patients with hepatic impairment.
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