البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
SUNITINIB AS MALATE
PFIZER PHARMACEUTICALS ISRAEL LTD
L01XE04
CAPSULES
SUNITINIB AS MALATE 12.5 MG
PER OS
Required
PFIZER INC, USA
SUNITINIB
SUNITINIB
Sutent is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate. Sutent is indicated for the treatment of advanced renal cell carcinoma.Treatment of unresectable or metastatic, well differentiated pancreatic neuroendocrine tumours (pNET) with disease progression.
2022-06-30
Sutent, PIL, Israel, CC 310522 2022-0078783 1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only SUTENT ® 12.5 MG SUTENT ® 25 MG SUTENT ® 50 MG CAPSULES SUNITINIB (AS MALATE) 12.5 MG, 25 MG, 50 MG For a list of inactive ingredients and allergens in the preparation: See section 2 under 'Important information about some of this medicine's ingredients' and section 6 'Further information’ . READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar to yours. This medicine is intended for adults above the age of 18. 1. WHAT IS THE MEDICINE INTENDED FOR? • For treatment of gastrointestinal stromal tumor (GIST). • For treatment of advanced renal cell carcinoma (aRCC). • For treatment of differentiated pancreatic neuroendocrine tumors (pNET), that have progressed or cannot be removed with surgery. THERAPEUTIC GROUP: Targeted tyrosine kinase receptor inhibitor. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the other ingredients in this medicine (listed in section 6). Before treatment with Sutent, tell the doctor: • If you are pregnant or planning to become pregnant, breastfeeding or planning to breastfeed. • If you have had a cerebral or cardiac event (e.g., any sort of heart attack, including myocardial infarction, heart failure, bypass surgery, heart muscle disease (cardiomyopathy), unstable angina pectoris) and/or pulmonary embolism during the 12 months before commencing treatment with the medicine. • If you suffer, or have suffered in the past, from impaired function of: the liver, the kidney/urinary tract, the pancreas, the اقرأ الوثيقة كاملة
Sutent 12.5 mg, 25 mg, 50 mg, LPD, Israel, CC 310522 2021-0069992, 2022-0078783 1 SUTENT ® 12.5 MG SUTENT ® 25 MG SUTENT ® 50 MG 1. NAME OF THE MEDICINAL PRODUCT Sutent 12.5 mg, capsules Sutent 25 mg, capsules Sutent 50 mg, capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains sunitinib malate, equivalent to 12.5, 25, 50 mg of sunitinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 12.5 mg capsules gelatin capsule with orange cap and orange body, printed with white ink “Pfizer” on the cap and “STN 12.5 mg” on the body. 25 mg capsules gelatin capsule with caramel cap and orange body, printed with white ink “Pfizer” on the cap and “STN 25 mg” on the body. 50 mg capsules gelatin capsule with caramel top and caramel body, printed with white ink “Pfizer” on the cap and “STN 50 mg” on the body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GASTROINTESTINAL STROMAL TUMOR SUTENT is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate. ADVANCED RENAL CELL CARCINOMA SUTENT is indicated for the treatment of advanced renal cell carcinoma. PANCREATIC NEUROENDOCRINE TUMORS (PNET) Treatment of unresectable or metastatic, well differentiated pancreatic neuroendocrine tumours (pNET) with disease progression. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy with sunitinib should be initiated by a physician experienced in the administration of anti- cancer agents. Posology For GIST and MRCC, the recommended dose of Sutent is 50 mg taken orally once daily, for 4 consecutive weeks, followed by a 2-week rest period (Schedule 4/2) to comprise a complete cycle of 6 weeks. Sutent 12.5 mg, 25 mg, 50 mg, LPD, Israel, CC 310522 2021-0069992, 2022-0078783 2 For pNET, the recommended dose of Sutent is 37.5 mg taken orally once daily without a scheduled rest period. _Dose adjustments _ _Safety and tolerability _ For GIST and MRCC, dose modifications in 12.5 mg steps may be applied based on اقرأ الوثيقة كاملة