Země: Indonésie
Jazyk: indonéština
Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT
2022-09-10
_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 Přečtěte si celý dokument