País: Israel
Idioma: anglès
Font: Ministry of Health
EVEROLIMUS
ABIC MARKETING LTD, ISRAEL
L04AA18
TABLETS
EVEROLIMUS 5 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
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 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 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 Teva is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. The effectiveness of Everolimus 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 Teva 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
2020-01-08
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only EVEROLIMUS TEVA 2.5 MG EVEROLIMUS TEVA 5 MG EVEROLIMUS TEVA 7.5 MG EVEROLIMUS TEVA 10 MG TABLETS COMPOSITION: Each tablet of Everolimus Teva 2.5 mg contains: Everolimus 2.5 mg Each tablet of Everolimus Teva 5 mg contains: Everolimus 5 mg Each tablet of Everolimus Teva 7.5 mg contains: Everolimus 7.5 mg Each tablet of Everolimus Teva 10 mg contains: Everolimus 10 mg FOR INFORMATION ABOUT INACTIVE INGREDIENTS AND ALLERGENS IN THE PREPARATION see section 2 - “Important information about some ingredients of the medicine” and section 6 - “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING the m e d i c i n e . T h i s l e a f l e t c o n t a i n s c o n c i s e i n f o r m a t i o n a b o u t t h e m e d i c i n e . I f y o u h a v e a d d i t i o n a l q u e s t i o n s , r e f e r t o t h e d o c t o r o r t h e pharmacist. T h i s m e d i c i n e h a s b e e n p r e s c r i b e d f o r t r e a t m e n t o f y o u r i l l n e s s . D o n o t p a s s i t o n t o o t h e r s . I t m a y h a r m t h e m e v e n i f i t s e e m s t o y o u t h a t t h e i r i l l n e s s i s similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Everolimus Teva is intended for: Treatment of patients with a brain tumor of the Subependymal Giant Cell Astrocytoma )SEGA( type 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 connected with a genetic condition known as Tuberous Sclerosis Complex. Treatment of patients with advanced neuroendocrine tumors of pancreatic origin that cannot be surgically removed, that have advanced locally or metastatic disease. Treatment of hormone receptor-positive and HER2-negative advanced breast cancer, in conjunction with exemestane, in postmenopa Llegiu el document complet