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
3,6 MG/DEPOT
CAIRAN INJEKSI
DUS, 1 SYRINGE @ 3,6 MG
ASTRAZENECA UK LIMITED
2017-10-07
- 1 - Page 1 of 9 ZOLADEX ® _ _ _goserelin _ IMPLANT/DEPOT 3.6 MG QUALITATIVE AND QUANTITATIVE COMPOSITION Goserelin acetate (equivalent to 3.6 mg goserelin) PHARMACEUTICAL FORM ZOLADEX is presented as a sterile, white to cream coloured cylindrical depot in which goserelin acetate (equivalent to 3.6 mg of goserelin) is dispersed in a biodegradable matrix of lactide-glycolide copolymer. It is supplied as a single dose SafeSystem ™ syringe applicator with a protective sleeve in a sealed pouch which contains a desiccant. THERAPEUTIC INDICATIONS i) Prostate cancer: ZOLADEX is indicated in the management of prostate cancer suitable for hormonal manipulation. ii) Breast cancer: ZOLADEX is indicated in the management of breast cancer in premenopausal and perimenopausal women suitable for hormonal manipulation. iii) Endometriosis: In the management of endometriosis, ZOLADEX alleviates symptoms, including pain, and reduces the size and number of endometrial lesions. iv) Endometrial thinning : ZOLADEX is indicated for the prethinning of the uterine endometrium prior to endometrial ablation or resection and endometrial biopsy prior to using Zoladex is not showing malignancy or atypical endometrial hyperplasia or pelvic inflammatory disease. v) Assited reproduction : Pituitary downregulation in preparation for superovulation. POSOLOGY AND METHOD OF ADMINISTRATION ADULTS 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 3.6 mg depot of ZOLADEX injected subcutaneously into the anterior abdominal wall every 28 days. DISETUJUI BPOM: 15/10/2019 ID: EREG10042211900037 - 2 - Page 2 of 9 Assisted reproduction: ZOLADEX is administered to downre Baca dokumen lengkapnya