Страна: Нова Зеландія
мова: англійська
Джерело: Medsafe (Medicines Safety Authority)
Exemestane 25mg
Teva Pharma (New Zealand) Limited
Exemestane 25 mg
25 mg
Film coated tablet
Active: Exemestane 25mg Excipient: Colloidal silicon dioxide Crospovidone Hypromellose E-5 Magnesium stearate Mannitol Microcrystalline cellulose Opadry white Polysorbate 80 Purified water Sodium starch glycolate
Blister pack, PVC/PVdC-Alu, 15 tablets
Prescription
Prescription
Sterling Srl
· Exaccord is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive or receptor unknown early breast cancer after initial adjuvant tamoxifen to reduce the risk of recurrence (distant and loco-regional) and contralateral breast cancer.
Package - Contents - Shelf Life: Blister pack, PVC/PVdC-Alu - 15 tablets - 30 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVdC-Alu - 30 tablets - 30 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVdC-Alu - 90 tablets - 30 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVdC-Alu - 120 tablets - 30 months from date of manufacture stored at or below 25°C
2010-08-17
Exaccord Tablets 25mg Version 2.0 -2010- Page 1 of 20 DATA SHEET NAME OF MEDICINE EXACCORD TABLETS 25MG (Exemestane tablets 25mg) PRESENTATION Exaccord Tablets 25 mg are presented as White to off-white, round, biconvex film coated tablets, debossed with 'E25' on one side and plain on the other. Inactive Ingredients: Exaccord Tablets 25mg also contain: microcrystalline cellulose(E460) mannitol,sodium starch glycolate(Type-A),crospovidone(Type A), hypromellose E5, polysorbate 80,Colloidal anhydrous silica (E551), magnesium stearate(E572), hydroxypropyl methylcellulose(E464),titanium dioxide(E171), macrogol. USES Pharmacodynamics 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. Exemestane acts by binding irreversibly to the active site of the enzyme causing its inactivation. 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- Exaccord Tablets 25mg Version 2.0 -2010- Page 2 of 20 90%) with a dose of 10-25 mg. In postmenopausal breast cancer patients treated with the 25 mg daily dose, whole body aromatisation 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 trials with multiple daily doses, exemestane had no detectable effects on adre Прочитайте повний документ