Exaccord

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Exemestane 25mg

Boleh didapati daripada:

Teva Pharma (New Zealand) Limited

INN (Nama Antarabangsa):

Exemestane 25 mg

Dos:

25 mg

Borang farmaseutikal:

Film coated tablet

Komposisi:

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

Unit dalam pakej:

Blister pack, PVC/PVdC-Alu, 15 tablets

Kelas:

Prescription

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

Sterling Srl

Tanda-tanda terapeutik:

· 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.

Ringkasan produk:

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

Tarikh kebenaran:

2010-08-17

Ciri produk

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