Страна: Нова Зеландия
Език: английски
Източник: Medsafe (Medicines Safety Authority)
Testosterone cipionate 100 mg/mL (101mg with manucturers overage.)
Pfizer New Zealand Limited
Testosterone cipionate 100 mg/mL (101mg with manucturers overage.)
100 mg/mL
Solution for injection
Active: Testosterone cipionate 100 mg/mL (101mg with manucturers overage.) Excipient: Benzyl alcohol Benzyl benzoate Cottonseed oil
Vial, 10 mL
Prescription
Prescription
Pharmacia & Upjohn Company LLC
DEPO-TESTOSTERONE Sterile Solution is indicated for replacement therapy in males in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
Package - Contents - Shelf Life: Vial, - 10 mL - 36 months from date of manufacture stored at or below 25°C protect from light
1969-12-31
Version: pfdtesti10221 Supercedes: pfdtesti10119 Page 1 of 10 NEW ZEALAND DATA SHEET 1. PRODUCT NAME DEPO-TESTOSTERONE ® 100mg/mL Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL solution for injection contains 100 mg/mL testosterone cypionate. Excipients with known effects: Benzyl alcohol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection DEPO-TESTOSTERONE is a slightly yellow viscous solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DEPO-TESTOSTERONE is indicated for replacement therapy in males in conditions associated with symptoms of deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumours, trauma, or radiation. 4.2 DOSE AND METHOD OF ADMINISTRATION Prior to initiating DEPO-TESTOSTERONE, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. DEPO-TESTOSTERONE is for intramuscular use only. It should not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle. DOSE The suggested dosage for DEPO-TESTOSTERONE varies depending on the age, sex, and diagnosis of the individual patient. Dosage is adjusted according to the patient’s response and the appearance of adverse reactions. Version: pfdtesti10221 Supercedes: pfdtesti10119 Page 2 of 10 Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses, with or without a decrease to maintenance levels. Other experts emphasise that higher dosages a Прочетете целия документ