Երկիր: Նոր Զելանդիա
Լեզու: անգլերեն
Աղբյուրը: Medsafe (Medicines Safety Authority)
Everolimus 5mg; ;
Novartis New Zealand Ltd
Everolimus 5 mg
5 mg
Tablet
Active: Everolimus 5mg Excipient: Butylated hydroxytoluene Crospovidone Hypromellose Lactose Lactose monohydrate Magnesium stearate
Blister pack, PA/AL/PVC, 30 tablets
Prescription
Prescription
Lek Pharmaceuticals d.d.
The treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery. The evidence is based on change in SEGA volume. Further clinical benefit, such as improvement of disease-related symptoms, has not been demonstrated.
Package - Contents - Shelf Life: Blister pack, PA/AL/PVC - 30 tablets - 36 months from date of manufacture stored at or below 30°C protect from light and moisture - Blister pack, PA/AL/PVC - 60 tablets - 36 months from date of manufacture stored at or below 30°C protect from light and moisture - Blister pack, PA/AL/PVC - 90 tablets - 36 months from date of manufacture stored at or below 30°C protect from light and moisture
2008-07-31
_ _ _Afinitor® _ _ _ _ _ _ Page 1 of 5_ _ _ _ _ _ _ _ _ Afinitor _2.5MG, 5MG AND 10MG TABLETS _ _EVEROLIMUS _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Afinitor. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.MEDSAFE.GOVT.NZ Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits . Your doctor has weighed the risks of you taking Afinitor against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. _ _ You may need to read it again. WHAT AFINITOR IS USED FOR Afinitor is used in the treatment of renal cell carcinoma, a type of kidney cancer; pancreatic neuroendocrine tumours (pNET), a type of cancer located in the pancreas; or subependymal giant cell astrocytoma (sometimes called ‘SEGA’), a specific type of brain tumour) associated with a disease called tuberous sclerosis. Everolimus is the active substance in Afinitor. Treatment of kidney cancer Afinitor stops the cancer from making new cells and cuts off the blood supply. This slows the growth and spread of the cancer. Treatment of pNET Afinitor is used to control the growth of these tumours located in the pancreas. Treatment of SEGA Afinitor reduces the size of brain s (SEGA) that are caused by a genetic disorder called tuberous sclerosis. This may stop the tumours from causing problems as they grow, such as hydrocephalus (excessive accumulation of fluid within the brain). THE MEDICINE IS STARTED BY A Կարդացեք ամբողջական փաստաթուղթը
NEW ZEALAND DATA SHEET 1 1. PRODUCT NAME Afinitor 2.5 mg tablets Afinitor 5 mg tablets Afinitor 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient of Afinitor 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. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White to slightly yellow, elongated tablets with a bevelled edge and no score. 2.5 MG: The tablets are engraved with “LCL” on one side and “NVR” on the other. 5 MG : The tablets are engraved with “5” on one side and “NVR” on the other. 10 MG: The tablets are engraved with “UHE” on one side and “NVR” on the other. ACTIVE SUBSTANCE Tablets 2.5 MG: Each tablet contains 2.5 mg everolimus. 5 MG : Each tablet contains 5 mg everolimus. 10 MG: Each tablet contains 10 mg everolimus. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Afinitor is indicated for the treatment of patients with: • Progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (NETs) of pancreatic origin • Advanced renal cell carcinoma in patients who have received prior VEGF-targeted therapy • Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery. The evidence is based on change in SEGA volume. Further clinical benefit, such as improvement in disease- related symptoms, has not been demonstrated. 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Afinitor should be administered orally once daily at the same time every day, either consistently with or consistently without food (see section 5 Pharmacological properties). Afinitor tablets should be swallowed whole with a glass of water. The tablets should not be chewed or crushed. For patients unable to swallow tablets, Afinitor tablet(s) should be dispersed completely in a glass of water (conta Կարդացեք ամբողջական փաստաթուղթը