Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
everolimus, Quantity: 5 mg
Teva Pharma Australia Pty Ltd
Everolimus
Tablet
Excipient Ingredients: butylated hydroxytoluene; hypromellose; lactose monohydrate; lactose; crospovidone; magnesium stearate
Oral
10 tablets, 30 tablets, 50 tablets, 60 tablets, 90 tablets
(S4) Prescription Only Medicine
The treatment of: - Postmenopausal women with hormone receptor-positive, HER2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole and anastrozole - Progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (NETs) of pancreatic origin - Advanced renal cell carcinoma after failure of treatment with sorafenib or sunitinib - Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not candidates for curative surgical resection - Patients with tuberous sclerosis complex (TSC) who have renal angiomyolipoma not requiring immediate surgery.
Visual Identification: White, oblong, flat, bevelled edge tablets, marked with "EV" on one side and "5" on the other; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-04-20
Product Information Page 1 TEVA-EVEROLIMUS 2.5 mg, 5 mg, 7.5 mg & 10 mg Tablets EVEROLIMUS-TEVA (EVEROLIMUS) NAME OF THE MEDICINE The active ingredient of Everolimus-Teva is everolimus. The chemical name is 40-O-(2-hydroxyethyl)-rapamycin or 40-O-(2-hydroxyethyl)-sirolimus. Its molecular formula is C 53 H 83 NO 14 and its molecular weight is 958.2. The structural formula of everolimus is: DESCRIPTION Everolimus is a white to faintly yellow powder practically insoluble in water but soluble in organic solvents such as ethanol and methanol. CAS number: 159351-69-6 Excipients: Butylated hydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone, lactose. Teva Pharma Australia Pty Ltd Version 1.0 2017-04-21 Product Information Page 2 TEVA-EVEROLIMUS 2.5 mg, 5 mg, 7.5 mg & 10 mg Tablets PHARMACOLOGY PHARMACODYNAMIC s MECHANISM OF ACTION Everolimus is a signal transduction inhibitor targeting mTOR (mammalian target of rapamycin), or more specifically, mTORC1 (mammalian 'target of rapamycin' complex 1). mTOR is a key serine-threonine kinase playing a central role in the regulation of cell growth, proliferation and survival. The regulation of mTORC1 signalling is complex, being modulated by mitogens, growth factors, energy and nutrient availability. mTORC1 is an essential regulator of global protein synthesis downstream on the PI3K/AKT pathway, which is dysregulated in the majority of human cancers. Constitutive activation of the PI3K/Akt/mTOR pathway can contribute to endocrine resistance in breast cancer. _In vitro _ studies show that oestrogen-dependent and HER2+ breast cancer cells are sensitive to the inhibitory effects of everolimus, and that combination of everolimus with Akt, HER2, or aromatase inhibitors synergistically enhances the anti-tumour effect of everolimus. Two primary regulators of mTORC1 signaling are the oncogene suppressors tuberin-sclerosis complexes 1 & 2 (TSC1, TSC2). Loss or inactivation of either TSC1 or TSC2 leads to elevated rheb-GTP levels, a ras family GTPase, which Lugege kogu dokumenti