देश: सिंगापुर
भाषा: अंग्रेज़ी
स्रोत: HSA (Health Sciences Authority)
Exemestane
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
L02BG06
TABLET, FILM COATED
Exemestane 25 mg
ORAL
Prescription Only
S.C. SINDAN-PHARMA S.R.L.
ACTIVE
2017-05-11
1. NAME OF THE MEDICINAL PRODUCT AROMASTAN F.C. TABLET 25MG 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg exemestane. For List of Excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablets White, round, biconvex film-coated tablets, with uniform appearance and intact edges. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Exemestane is indicated for the adjuvant treatment of post- menopausal women with estrogen-receptor positive invasive early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy. 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- estrogen therapy. 4.2. 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 early breast cancer, treatment with exemestane should continue until completion of five years of combined sequential adjuvant hormonal therapy (tamoxifen followed by exemestane), or earlier if tumor relapse occurs. In patients with advanced breast cancer, treatment with exemestane should continue until tumor progression is evident. Hepatic or Renal Insufficiency No dose adjustments are required for patients with hepatic or renal insufficiency. Children Not recommended for use in children. 4.3. CONTRAINDICATIONS Exemestane is contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Because of its mode of action, exemestane should not be administered to women with pre-menopausal endocrine status. Therefore, whenever clinically appropriate, the post-menopausal status should be ascertained by assessment of LH, FSH and estradiol levels. Exemestane should not be co-administered with estrogen- containing products as these would negate its pharmacological action. Exemestane should be used with caution in patien पूरा दस्तावेज़ पढ़ें