País: Indonesia
Idioma: indonesio
Fuente: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LEUPRORELIN ACETATE
TAKEDA INDONESIA - Indonesia
LEUPRORELIN ACETATE
1,88 MG + PELARUT 2 ML
SERBUK INJEKSI
DUS,1 VIAL @ 1,88 MG + 1 AMPUL PELARUT 2 ML
TAKEDA INDONESIA - Indonesia
2018-09-12
Page 1 of 7 TAPROS DEPOT 1.88 mg LEUPRORELIN ACETATE 1 NAME OF THE MEDICINAL PRODUCT TAPROS 2 COMPOSITION Each vial contains 1.88 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 1. 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. 2. Treatment of central precocious puberty. 4.2 Posology and Method of Administration 1. 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. 2. 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 leuprorelin, Gn-RH derivatives, to Gn-RH analogues or to one of the components. All females (adult and pubescent pediatric females) - Vaginal bleedings of non determined origin. - Pregnancy. Do not use when pregnancy. The non pregnancy must be confirmed before treatment. - Nursing. Because of the lack of data regarding TAPROS excretion in milk and its potential effects on nursing mothers, TAPROS will not have to be used in this case. DISETUJUI OLEH BPOM : 20/05/2021 ID : EREG10023512100012 Page 2 of 7 4.4 Special warnings and precautions for use PRECAUTION All patient populations Since Tapros is a sustained release preparation with its action lasting 4 weeks, administration at an in Leer el documento completo