Testosterone Enantate 250 mg ml Solution for Injection Ampoules Summary of Product Characteristics SmPC emc

Older patients treated with androgens may be at increased risk for the development of prostatic hyperplasia. Although there are no clear indications that androgens actually generate prostatic https://mundogeografia.com/die-bedeutung-der-genetik-fur-den-steroid-3/ carcinoma, these can enhance the growth of any existing prostatic carcinoma. Therefore carcinoma of the prostate has to be excluded before starting therapy with testosterone preparations.

• Cases of benign and malignant liver tumours, which may lead to life-threatening intra-abdominal haemorrhage, have been observed after the use of Testosterone Enantate.
• To stimulate development of underdeveloped androgen-dependent organs and for initial treatment of deficiency symptoms, 250mg Testosterone Enantate intramuscularly every two to three weeks.
• Testosterone level should be monitored at baseline and at regular intervals during treatment.
• There is limited experience on the safety and efficacy of the use of Testosterone Enantate in patients over 65 years of age.
• Caution should be exercised in patients predisposed to oedema, as treatment with androgens may result in increased sodium retention (see 4.8 Undesirable effects).

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. • Peak serum testosterone levels of 1233 ± 484 ng/ml were achieved at 24 hours. Testosterone Enantate replacement therapy may reversibly reduce spermatogenesis (see 4.8 Undesirable effects and 5.3 Preclinical safety data). Testosterone Enantate should not be used in women since, depending on the individual sensitivity to androgenic impulses, women may develop signs of virilisation, e.g. acne, hirsutism, voice changes. To stimulate development of underdeveloped androgen-dependent organs and for initial treatment of deficiency symptoms, 250mg Testosterone Enantate intramuscularly every two to three weeks. Testosterone Enantate is an ester of the natural male sex hormone testosterone and exhibits all the pharmacological effects of the natural hormone.

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Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests. Each 1ml ampoule contains 250mg Testosterone Enantate (the equivalent of about 180 mg testosterone) in oily solution. • Physiological levels of testosterone (approx. 500 ng/ml) were maintained for 11 days.

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Long-term systemic studies showed no evidence of testicular toxicity although a temporary inhibition of spermatogenesis may occur. Testosterone Enantate should not be administered during pregnancy due to the possibility of virilisation of the female foetus. However, investigations into embryotoxic, in particular teratogenic, effects gave no indication that further impairment of organ development may occur.

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High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation of benzyl alcohol and toxicity (metabolic acidosis). There is limited experience on the safety and efficacy of the use of Testosterone Enantate in patients over 65 years of age. Currently, there is no consensus about age specific testosterone reference values.