البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
EVEROLIMUS
TARO INTERNATIONAL LTD, ISRAEL
L04AA18
TABLETS
EVEROLIMUS 10 MG
PER OS
Required
SYNTHON CHILE LTDA, CHILE
EVEROLIMUS
- For the treatment of patients with SEGA associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not candidates for curative surgical resection. The effectiveness of Everolimus Taro is based on an analysis of change in SEGA volume. Clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated.- Treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease.The safety and effectiveness of Everolimus Taro in the treatment of patients with carcinoid tumors have not been established.- For the treatment of hormone receptor – positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.- Everolimus Taro is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. The effectiveness of Everolimus Taro in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. Further follow-up of patients is required to determine long-term outcomes.- Everolimus Taro is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.- Treatment of unresectable, locally advanced or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.
2021-08-04
Page 1 of 10 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only EVEROLIMUS TARO 2.5 MG, EVEROLIMUS TARO 5 MG, EVEROLIMUS TARO 10 MG TABLETS TABLETS TABLETS ACTIVE INGREDIENT: ACTIVE INGREDIENT: ACTIVE INGREDIENT: Each tablet contains: Each tablet contains: Each tablet contains: everolimus 2.5 mg everolimus 5 mg everolimus 10 mg Inactive ingredients and allergens: See section 2 under 'Important information regarding some of this medicine's ingredients' and section 6 'Further Information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Everolimus Taro 2.5, 5 and 10 mg tablets are intended for: • Treatment of patients with a subependymal giant cell astrocytoma (SEGA), a type of brain tumor associated with tuberous sclerosis complex (TSC) for whom surgery is not appropriate. • Treatment of adult patients with a kidney tumor known as angiomyolipoma (AML) when the kidney tumor does not require immediate surgery. This type of tumor is associated with a genetic condition known as tuberous sclerosis complex. • Treatment of advanced hormone receptor-positive and HER2-negative breast cancer, in conjunction with exemestane, in postmenopausal women without symptomatic metastatic disease spread to internal organs, after recurrence or progression of the disease following treatment with nonsteroidal aromatase inhibitors. • Treatment of advanced kidney cancer [advanced renal cell carcinoma (RCC)], where other treatments that target vascular endothelial growth factor (VEGF-targeted therapy) have not helped stop your disease. • Treatment of locally advanced, metastatic or اقرأ الوثيقة كاملة