Testoviron Depot (testosterone enanthate) 250 mg/ml solution for injection.
Package contains: Testoviron Depot package contains solution 3 ampules of 1ml (solution for injection).
Composition: 1 ml testosterone enanthate USP 250mg in oily solution. For intramuscular injection.
Indication(s): Male hypogonadism (Male hypogonadism is a condition in which the body doesn’t produce enough of the hormone that plays a key role in masculine growth and development during puberty (testosterone) or enough sperm or both).
Dosage & method of Administration: To be used according to the physician’s advice.
Solution for intramuscular injection. The injection must be administered extremely slowly. The oily solution is injected immediately after its drawing up into the syringe.
Dosage regiment: For the development and stimulation of still underdeveloped androgen dependent target organs and for the initial treatment of deficiency symptoms: 250 mg i.m. every 2-3 weeks.
To maintain an adequate androgenic effect, 250mg i.m. every 3-4 weeks. Shorter injection intervals may be necessary depending on the individual requirement for hormone, but longer intervals of up to 6 weeks are also sufficient in many cases.
Serum testosterone levels should be measured before treatment and occasionally during the treatment at the end of an injection interval. Serum levels below the 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.
Pediatric patients: Testoviron Depot is not indicated for use in children and adolescents. In children testosterone, besides masculinization, can cause accelerated growth and bone maturation and premature epiphyseal closure, thereby reducing final height.
Patients with renal impairment: no formal studies have been performed in patients with renal imperilment.
Androgen-dependent carcinoma of the prostate of the male mammary gland.
Hypercalcemia accompanying malignant tumors past or present liver tumors.
Hypersensitivity to the active substance or to any of the excipients.
Pregnancy & Lactation: Testoviron Depot is intended for use by men only. Testoviron Depot is not indicated in pregnant & breastfeeding women.
Fertility & special warning: testosterone replacement therapy may reversibly reduce spermatogenesis. Testoviron Depot should not be used in women since, depending on the individual sensitivity to androgenic impulse, women may develop signs of virilization, e.g acne, hirsutism, and voice changes.
Special Warnings & precautions to use:
Caution should be exercised in patients predisposed to edema, e.g in case of severe cardiac, hepatic, or renal insufficiency or ischemic heart diseases, as treatment with androgens may increase sodium and water.
In case of severe complications characterized by edema with or without congestive heart failure treatment must be stopped immediately.
Testosterone may cause a rise in blood pressure and should be used with caution in men with hypertension.
Instruction: Store below 30°C. Protect from light. Keep out of reach of children. Direction for use enclosed. To be sold on the prescription of a registered medical practitioner only.
Manufactured by: Bayer Pvt Ltd. https://www.bayer.com
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