Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
exemestane, Quantity: 25 mg
Accord Healthcare Pty Ltd
Exemestane
Tablet, film coated
Excipient Ingredients: colloidal anhydrous silica; sodium starch glycollate type A; hypromellose; mannitol; microcrystalline cellulose; magnesium stearate; crospovidone; polysorbate 80; titanium dioxide; macrogol 400
Oral
30 Tablets, 15 Tablets, 90 Tablets
(S4) Prescription Only Medicine
Exemestane is indicated for the sequential adjuvant treatment of oestrogen receptor-positive early breast cancer in post-menopausal women who have received prior adjuvant tamoxifen therapy. . Exemestane is indicated for the treatment of oestrogen receptor-positive advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy.
Visual Identification: White to off-white, round, biconvex film-coated tablets debossed with 'E25' on one side and plain on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-02-09
Exemestane Intas (Exemestane film-coated tablets 25mg) Version: 1.1 2017 Page: 1 of 14 PRODUCT INFORMATION EXEMESTANE INTAS (EXEMESTANE FILM-COATED TABLETS 25 MG) NAME OF THE MEDICINE exemestane Structural formula: Chemical name: 6-methylenandrosta-1,4-diene-3,17-dione. CAS number: CAS-107868-30-4 Exemestane has a molecular formula of C 20 H 24 O 2 and a molecular weight of 296.4. DESCRIPTION Exemestane is a white or yellowish-white powder, which is freely soluble in N,N- dimethylformamide, soluble in methanol and practically insoluble in water. Due to the very low solubility in water, the medicine is micronised. Exemestane Intas are white to off-white, round, biconvex film-coated tablets debossed with ‘E25’ on one side and plain on the other. Exemestane Intas tablets contain the following excipients: Mannitol, Microcrystalline cellulose, Crospovidone, Sodium starch glycollate (Type A), Hypromellose, Polysorbate 80, Colloidal anhydrous silica, Magnesium stearate and Opadry Complete Film Coating System 03B58900 White (Ingredient ID: 106176). PHARMACOLOGY PHARMACODYNAMICS Exemestane is an irreversible, steroidal aromatase inactivator, structurally related to the natural substrate androstenedione. In post-menopausal women, oestrogens are produced Exemestane Intas (Exemestane film-coated tablets 25mg) Version: 1.1 2017 Page: 2 of 14 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. Exemestane acts by binding irreversibly to the active site of the enzyme causing its i nactivation. Such type of inactivation is also known as “suicidal inhibition”. In postmenopausal women, exemestane significantly lowered serum oestrogen concentrations starting from a 5 mg dose, reaching maximal suppression (80-90%) with a dose of 10-25 mg. In postmenopausal breast cancer patients treated with the 25 mg daily dose, whole Přečtěte si celý dokument