Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
GOSERELIN ACETATE
ASTRAZENECA INDONESIA - Indonesia
GOSERELIN ACETATE
10.8 Mg
INJEKSI
DUS, 1 SYRINGE @ 10,8 MG
ASTRAZENECA UK LIMITED - United Kingdom
2020-08-14
Page 1 of 7 ZOLADEX ® LA _goserelin_ IMPLANT/DEPOT 10.8 MG QUALITATIVE AND QUANTITATIVE COMPOSITION Goserelin acetate (equivalent to 10.8 mg goserelin) PHARMACEUTICAL FORM ZOLADEX LA is presented as a sterile, white to cream coloured cylindrical depot in which goserelin acetate (equivalent to 10.8 mg of goserelin) is dispersed in a biodegradable matrix of lactide-glycolide co-polymer. It is supplied as a single dose SafeSystem™ syringe applicator with a protective sleeve in a sealed pouch which contains a desiccant. THERAPEUTIC INDICATIONS PROSTATE CANCER : ZOLADEX LA is indicated in the management of prostate cancer suitable for hormonal manipulation. PREMENOPAUSAL BREAST CANCER : ZOLADEX LA is indicated in the management of premenopausal breast cancer for hormone receptor positive. ENDOMETRIOSIS : ZOLADEX LA is indicated in the management of endometriosis including alleviation of symptoms such as pain. Experience with Zoladex LA for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months. POSOLOGY AND METHOD OF ADMINISTRATION ADULT MALES (INCLUDING THE ELDERLY) Caution should be taken while inserting ZOLADEX into anterior abdominal wall due to the proximity of underlying inferior epigastric artery and its branches Use extra care when administering ZOLADEX to patients with a low body mass index (BMI) and/or who are receiving full anticoagulation medication (_see special warning and special _ _precautions for use_) For correct administration of ZOLADEX, see instructions on the instruction card. One 10.8 mg depot of ZOLADEX LA injected subcutaneously into the anterior abdominal wall, every 12 weeks. No dosage adjustment is necessary for patients with renal impairment. No dosage adjustment is necessary for patients with hepatic impairment. FEMALES One 10.8 mg depot of ZOLADEX LA injected subcutaneously into the anterior abdominal wall, every 12 weeks. DISETUJUI BPOM : 16/03/2020 ID : EREG10042211900038 Page 2 of 7 CHILDREN ZOLADEX LA is not indicated for use in ch Baca dokumen lengkapnya