Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
EVEROLIMUS
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
EVEROLIMUS
30tablet Tablets
NOVARTIS PHARMA STEIN AG
_ _ _ _ _Consumer Medication Information Leaflet (RiMUP) _ AFINITOR ® TABLET EVEROLIMUS (2.5MG, 5MG, 10MG) AFINITOR ® DISPERSIBLE TABLET EVEROLIMUS (2 MG, 3 MG, 5 MG) 1 WHAT IS IN THIS LEAFLET 1. WHAT IS AFINITOR/AFINITOR DISPERSIBLE USED FOR 2. HOW AFINITOR/AFINITOR DISPERSIBLE WORKS 3. BEFORE YOU USE AFINITOR/ AFINITOR DISPERSIBLE 4. HOW TO USE AFINITOR/AFINITOR DISPERSIBLE 5. WHILE YOU ARE USING AFINITOR/AFINITOR DISPERSIBLE 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF AFINITOR/AFINITOR DISPERSIBLE 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION WHAT AFINITOR/ AFINITOR DISPERSIBLE IS USED FOR WHAT IS AFINITOR USED FOR? AFINITOR is a prescription medicine used to treat: • Advanced hormone receptor- positive, HER2-negative breast cancer, along with the medicine _exemestane_ , in postmenopausal women who have already received certain other medicines for their cancer. • Adults with a type of pancreatic cancer known as pancreatic neuroendocrine tumor (PNET) that has progressed and cannot be treated with surgery. • Adults with a type of cancer known as neuroendocrine tumor (NET) of the stomach and intestine (gastrointestinal), or lung that has progressed and cannot be treated with surgery. AFINITOR is not for use in people with carcinoid tumors that actively produce hormones. • Adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines have not worked. • People with the following types of tumors that are seen with a genetic condition called tuberous sclerosis complex (TSC): _-_ _ _ Adults with a kidney tumor called angiomyolipoma, when their kidney tumor does not require surgery right away. _-_ _ _ Adults and children 1 year of age and older with a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery. WHAT IS AFINITOR DISPERSIBLE USED FOR? AFINITOR DISPERSIBLE is a prescription medicine used to treat: • Adults and children 1 year of age and older with a genetic co Belgenin tamamını okuyun
Novartis Page 2 Malaysia Package Insert 31-May-2021 Afinitor ® 1 INDICATIONS AND USAGE AFINITOR tablets are indicated for the • treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole. • treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy. • treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease. AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors. • treatment of adult patients with progressive, well-differentiated (Grade 1 or Grade 2), non- functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease. AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors. • treatment of adult and pediatric patients, 1 years of age and older, with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not candidates for curative surgical resection. The effectiveness of AFINITOR is based on an analysis of change in SEGA volume (see section CLINICAL STUDIES). Clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated. • treatment of adult patients with renal angiomyolipoma (AML) and tuberous sclerosis complex (TSC), not requiring immediate surgery. The effectiveness of AFINITOR in the 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. AFINITOR DISPERSIBLE tablets are indicated for the • treatment of adult and pediatric patients, 1 years of age and ol Belgenin tamamını okuyun