Country: Indoneżja
Lingwa: Indoneżjan
Sors: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ANASTROZOLE
ASTRAZENECA INDONESIA - Indonesia
ANASTROZOLE
1 MG
TABLET SALUT SELAPUT
DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT
ASTRAZENECA PHARMACEUTICAL COMPANY LTD.
2017-11-09
_Page 1 of 9 _ ARIMIDEX ® _anastrozole _ FILM-COATED TABLETS QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 mg anastrozole. PHARMACEUTICAL FORM Film-coated tablet. White, round, biconvex tablet with logo on one side and strength on the other. THERAPEUTIC INDICATIONS Treatment of advanced breast cancer in post-menopausal women with oestrogen receptor positive and or progesterone receptor positive. Adjuvant treatment of post-menopausal women with hormone receptor positive early invasive breast cancer. Adjuvant treatment of early breast cancer in hormone receptor positive post-menopausal women, who have received 2 to 3 years of adjuvant tamoxifen. POSOLOGY AND METHOD OF ADMINISTRATION Adults including elderly : One 1 mg tablet to be taken orally once a day. For patients with advanced breast cancer, ARIMIDEX should be continued until tumour progression. Children : The use of ARIMIDEX is not recommended in children, as efficacy has not been established. Renal impairment : No dose change is recommended in patients with mild or moderate renal impairment. Hepatic impairment : No dose change is recommended in patients with mild hepatic disease. CONTRAINDICATIONS ARIMIDEX is contraindicated in: - pre-menopausal women - pregnant or lactating women - patients with severe renal impairment (creatinine clearance less than 20 ml/min) - patients with moderate or severe hepatic disease - patients with known hypersensitivity to anastrozole or to any of the excipients as referenced on the _List of Excipients_ Oestrogen – containing therapies should not be co-administered with ARIMIDEX as they would negate its pharmacological action. Concurrent tamoxifen therapy (see section _Interaction with other medicinal products and _ _other forms of interaction_). DISETUJUI OLEH BPOM : 02/11/2021 ID : EREG100422VR12100210 _Page 2 of 9 _ SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE ARIMIDEX is not recommended for use in children, as safety and efficacy have not been established in this group of patients. ARIMI Aqra d-dokument sħiħ