Country: Israel
Language: English
Source: Ministry of Health
SUNITINIB
TARO INTERNATIONAL LTD, ISRAEL
L01XE04
HARD CAPSULE
SUNITINIB 12.5 MG
PER OS
Required
PHARMACARE PREMIUM LTD., MALTA
SUNITINIB
Sunitinib taro is indicated for:• Treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate. • Treatment of advanced renal cell carcinoma.• Treatment of unresectable or metastatic, well differentiated pancreatic neuroendocrine tumours (pNET) with disease progression.
2021-07-28
Page 1 of 6 Sunitinib Taro, PIL, Israel PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only Sunitinib Taro 12.5 mg Sunitinib Taro 25 mg Sunitinib Taro 37.5 mg Sunitinib Taro 50 mg Hard capsules Active ingredient Sunitinib 12.5 mg, 25 mg, 37.5 mg, 50 mg Inactive ingredients and allergens: 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 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. 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) after disease progression on or intolerance to imatinib mesylate. 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 (see section 6). Special warnings about using this medicine Before treatment with Sunitinib Taro, tell the doctor if: You are pregnant or planning to become pregnant, breastfeeding or planning to breastfeed. 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 Page 2 of 6 Sunitinib Taro, PIL, Israel (cardiomyopathy), unstable angina pectoris) and/or pulmonary embolism during the 12 months before commencing Read the complete document