Krajina: Indonézia
Jazyk: indonézština
Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
EXEMESTANE
PFIZER INDONESIA - Indonesia
EXEMESTANE
25 MG
TABLET SALUT GULA
DUS, 2 BLISTER @ 15 TABLET SALUT GULA
PFIZER ITALIA S.R.L - Italy
2021-05-26
Generic Name: Exemestane tablets Trade Name: Aromasin CDS Effective Date: June 03, 2021 Supersedes: September 07, 2017 Approved by BPOM: 2021-0068641, 2021-0068642 Page 1 of 10 PT. PFIZER INDONESIA Local Product Document Generic Name: Exemestane tablets Trade Name: Aromasin ® CDS Effective Date: June 03, 2021 Supersedes: September 07, 2017 DESCRIPTION Aromasin tablets for oral administration contain 25 mg of exemestane, in irreversible, steroidal aromatase inactivator. Exemestane is chemically described as 6-methylenandrosta-1,4-diene-3,17-dione. Its molecular formula is C 20 H 24 O 2 and its structural formula is as follows: The active ingredient is a white to slightly yellow crystalline powder with a molecular weight of 296.41. Exemestane is freely soluble in N,N-dimethylformamide, soluble in methanol and practically insoluble in water. CLINICAL PARTICULARS THERAPEUTIC INDICATION Exemestane is indicated for the treatment of advanced breast cancer in women with natural or induced post-menopausal status whose disease has progressed following anti-oestrogen therapy. Patient selection should be based on positive oestrogen and/or progesterone receptor status, because efficacy has not been demonstrated when it is absent. Exemestane is indicated for the adjuvant treatment of post-menopausal women with estrogen-receptor positive early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy. POSOLOGY AND METHOD OF ADMINISTRATION Adult and Elderly Patients The recommended dose of exemestane is one 25 mg tablet to be taken once daily, preferably after a meal. In patients with advanced breast cancer, treatment with exemestane should continue until tumor progression is evident. In patients with early breast cancer, treatment with exemestane should continue until completion of five years of adjuvant endocrine therapy, or until local or distant recurrence or new contralateral breast cancer. Hepatic or Renal Insufficiency No dose adjustments are required for patients with hepatic or renal insufficiency. C Prečítajte si celý dokument