Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
everolimus, Quantity: 10 mg
Novartis Pharmaceuticals Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: butylated hydroxytoluene; lactose monohydrate; hypromellose; magnesium stearate; crospovidone; lactose
Oral
100 Tablets, 60 Tablets, 50 Tablets, 30 tablets, 120 Tablets
(S4) Prescription Only Medicine
EVEROLIMUS SANDOZ is indicated for the treatment of:,? Postmenopausal women with hormone receptor-positive, HER2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ? Progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (NETs) of pancreatic origin. ? Progressive, unresectable or metastatic, well-differentiated, non-functional neuroendocrine tumours (NET) of gastrointestinal or lung origin in adults. ? 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 to slightly yellowish, elongated tablet with a bevelled edge. One side debossed with 'NVR' and the other side with 'UHE'.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2018-02-01
EVEROLIMUS SANDOZ ® _everolimus_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about EVEROLIMUS SANDOZ. 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.NOVARTIS.COM.AU. 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 EVEROLIMUS SANDOZ 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 EVEROLIMUS SANDOZ IS USED FOR EVEROLIMUS SANDOZ is used in the treatment of renal cell carcinoma, a type of kidney cancer; neuroendocrine tumours (NETs), a type of cancer located in the stomach and intestine, lung or pancreas; tuberous sclerosis complex (TSC) with angiomyolipoma of the kidney (a kidney tumour) not requiring immediate surgery; or TSC with subependymal giant cell astrocytoma (sometimes called 'SEGA'), a specific type of brain tumour not requiring immediate surgery. EVEROLIMUS SANDOZ is also used in the treatment of hormone receptor-positive HER2 negative advanced breast cancer in postmenopausal women, in conjunction with exemestane after failure of letrozole or anastrozole. It is only used in patients whose tumour has tested negative to HER2. Everolimus is the active substance in EVEROLIMUS SANDOZ. TREATMENT OF KIDNEY CANCER EVEROLIMUS SANDOZ stops the cancer from making new cells and cuts off the blood supply. This slows the growth and spread of the cancer. TREATMENT OF NETS Aqra d-dokument sħiħ
1 AUSTRALIAN PI – EVEROLIMUS SANDOZ (EVEROLIMUS) TABLETS 1 NAME OF THE MEDICINE Everolimus. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Everolimus Sandoz tablet contains either 2.5 mg, 5 mg or 10 mg everolimus. Excipients: with known effect: contains sugars as lactose. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM 2.5 mg tablet: White to slightly yellowish, elongated tablet with a bevelled edge and no score engraved with “LCL” on one side and “NVR” on the other. 5 mg tablet: White to slightly yellowish, elongated tablet with a bevelled edge and no score engraved with “5” on one side and “NVR” on the other. 10 mg tablet: White to slightly yellowish, elongated tablet with a bevelled edge and no score engraved with “UHE” on one side and “NVR” on the other. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Everolimus Sandoz is indicated for the: • Treatment of postmenopausal women with hormone receptor-positive, HER2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. • Treatment of progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (NETs) of pancreatic origin. • Treatment of progressive, unresectable or metastatic, well-differentiated, non-functional neuroendocrine tumours (NET) of gastrointestinal or lung origin in adults. • Treatment of advanced renal cell carcinoma after failure of treatment with sorafenib or sunitinib. • Treatment of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not candidates for curative surgical resection. • Treatment of patients with tuberous sclerosis complex (TSC) who have renal angiomyolipoma not requiring immediate surgery. 2 4.2 D OSE AND METHOD OF ADMINISTRATION Treatment with Everolimus Sandoz should be initiated by a physician experienced in the use of anticancer therapies or in the treatment Aqra d-dokument sħiħ