Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
EXEMESTANE
ACCORD HEALTHCARE SDN.BHD.
EXEMESTANE
30tablet Tablets
INTAS PHARMACEUTICALS LTD
Consumer Medication Information Leaflet (RiMUP) 1 Exetas 25 mg Tablets Exemestane Tablets (25 mg) What is in this leaflet 1. What Exetas 25mg Tablets is used for. 2. How Exetas works. 3. Before you use Exetas 4. How to take Exetas. 5. While you are using Exetas 6. Side effects. 7. After using Exetas 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision. What Exetas 25mg Tablets is used for Exetas 25mg Tablets is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer, following 2 – 3 years of initial adjuvant tamoxifen therapy. Exetas is indicated for the treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy. Efficacy has not been demonstrated in patients with oestrogen receptor negative status. How Exetas works Exetas belongs to a group of medicines known as aromatase inhibitors. These drugs interfere with a substance called aromatase, which is needed to make the female sex hormones, estrogens, especially in postmenopausal women. Reduction in oestrogen levels in the body is a way of treating hormone dependent breast cancer. Before you use Exetas -When you must not take it You are allergic to exemestane or any of the other ingredients of Exetas tablets. You still have periods, i.e. if you have not yet gone through the menopause. You are pregnant You are breast-feeding -Before you start to take it Before treatment with Exetas, your doctor may want to take blood samples to make sure you have reached the menopause. Tell your doctor if you have problems with your liver or kidneys Tell your doctor if you have a history of osteoporosis (thinning or wasting of bones) or bone fractures. -Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Children and adolescents (b Olvassa el a teljes dokumentumot
EXETAS 25 MG TABLET Exemestane Tablets 25 mg COMPOSITION: EACH FILM COATED TABLET CONTAINS: Exemestane 25 mg DOSAGE FORM: Tablet PRODUCT DESCRIPTION White to off –white , round, biconvex film coated tablets debossed with ‘E25’ on one side and plain on the other. PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: steroidal aromatase inhibitor; anti- neoplastic agent ATC: L02BG06 Exemestane is an irreversible, steroidal aromatase inhibitor, structurally related to the natural substrate androstenedione. In post-menopausal women, oestrogens are produced primarily from the conversion of androgens into oestrogens through the aromatase enzyme in peripheral tissues. Oestrogen deprivation through aromatase inhibition is an effective and selective treatment for hormone dependent breast cancer in postmenopausal women. In postmenopausal women, Exemestane p.o. significantly lowered serum oestrogen concentrations starting from a 5 mg dose, reaching maximal suppression (>90%) with a dose of 10-25 mg. In postmenopausal breast cancer patients treated with the 25 mg daily dose, whole body aromatization was reduced by 98%. Exemestane does not possess any progestogenic or oestrogenic activity. A slight androgenic activity, probably due to the 17-hydro derivative, has been observed mainly at high doses. In multiple daily doses trials, Exemestane had no detectable effects on adrenal biosynthesis of cortisol or aldosterone, measured before or after ACTH challenge, thus demonstrating its selectivity with regard to the other enzymes involved in the steroidogenic pathway. Glucocorticoid or mineralocorticoid replacement are therefore not needed. PHARMACOKINETIC PROPERTIES ABSORPTION: After oral administration of Exemestane tablets, exemestane is absorbed rapidly. The fraction of the dose absorbed from the gastrointestinal tract is high. The absolute bioavailability in humans is unknown, although it is anticipated to be limited by an extensive first pass effect. A similar effect resulted in an absolute bioavailability in rats and d Olvassa el a teljes dokumentumot