Šalis: Indonezija
kalba: indoneziečių
Šaltinis: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TAKEDA INDONESIA - Indonesia
3,75 MG/VIAL
SERBUK INJEKSI
DUS, 200 AMPUL @ 2 ML (BULK)
TAKEDA PHARMACEUTICAL COMPANY - Japan
2018-09-12
Page 1 of 11 TAPROS DEPOT 3.75 mg LEUPRORELIN ACETATE 1 NAME OF THE MEDICINAL PRODUCT TAPROS DEPOT 3.75 mg 2 COMPOSITION Each vial contains 3.75 mg Leuprorelin Acetate For excipients, see section 6.1. 3 PHARMACEUTICAL FORM White powder and clear, colorless solvent for suspension for injection. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications - Treatment of prostatic cancer with metastase. - Treatment of endometriosis at genital and extragenital localization (from stage I to stage IV). The clinical knowledge concerning the endometriosis treatment is limited to women over 18 years old. The treatment duration is limited to 6 months. - Pre-operative management of uterine myoma (fibroid) to reduce their size and associated bleeding. - Treatment of central precocious puberty. - Breast cancer in pre-menopausal and peri-menopausal women, provided endocrine treatment is indicated. It is not recommended to start a second treatment period with Tapros or with another Gn-RH analogue. 4.2 Posology and method of administration - Prostatic cancer and breast cancer One subcutaneous injection which will be renewed every four weeks. - Endometriosis Usually, for adults, 3.75 mg of leuprorelin acetate is administered subcutaneously or intramuscularly once every 4 weeks for a period of 6 months only. However, when the patient’s weight is less than 50 kg, 1.88 preparation may be used. The treatment should start during the five first days of the menstrual cycle. - Uterine myoma (fibroid) One subcutaneous or intramuscular injection will be renewed every 4 weeks. The treatment should start during the five first days of the menstrual cycle. - Central precocious puberty Usually, a dose of 30 µg/kg administer subcutaneously once every 4 weeks. Depending upon the patient’s condition, the dosage may be increased up to 90 µg/kg. The safety of Tapros in prematures, newborns, and nursing infants has not been established. 4.3 Contraindications All patient populations - Hypersensitivity to Gn-RH, to Gn-RH analogues or to one of the Perskaitykite visą dokumentą