מדינה: ישראל
שפה: אנגלית
מקור: Ministry of Health
PONATINIB AS HYDROCHLORIDE
MEDISON PHARMA LTD
L01XE24
COATED TABLETS
PONATINIB AS HYDROCHLORIDE 15 MG
PER OS
Required
INCYTE BIOSCIENCES DISTRIBUTION B.V., NETHERLANDS
PONATINIB
Iclusig is indicated in adult patients with: • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation • Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
2020-02-29
Iclusig- PIL-0522-V1 Iclusig-15_30_45mg-PIL-ENG-D14-F PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine can be sold with a doctor's prescription only ICLUSIG 15 MG COATED TABLETS ICLUSIG 30 MG COATED TABLETS ICLUSIG 45 MG COATED TABLETS EACH 15 MG ICLUSIG TABLET CONTAINS 15 MG OF PONATINIB (AS HYDROCHLORIDE). EACH 30 MG ICLUSIG TABLET CONTAINS 30 MG OF PONATINIB (AS HYDROCHLORIDE). EACH 45 MG ICLUSIG TABLET CONTAINS 45 MG OF PONATINIB (AS HYDROCHLORIDE). WARNING: VASCULAR OCCLUSION, HEART FAILURE AND HEPATOTOXICITY. VASCULAR OCCLUSION: BLOOD CLOTS IN THE ARTERIES AND VEINS, AND VASCULAR OCCLUSION OCCURRED IN APPROXIMATELY 27% OF PATIENTS TREATED WITH ICLUSIG, INCLUDING FATAL MYOCARDIAL INFARCTION, STROKE, STENOSIS OF LARGE ARTERIAL VESSELS OF THE BRAIN, SEVERE PERIPHERAL VASCULAR DISEASE AND THE NEED FOR URGENT REVASCULARIZATION PROCEDURES. PATIENTS WITH AND WITHOUT CARDIAC RISK FACTORS, INCLUDING THOSE UNDER 50 YEARS OF AGE, HAVE EXPERIENCED THESE SYMPTOMS. HEART FAILURE, INCLUDING CASES THAT CAUSED DEATH, OCCURRED IN 8% OF PATIENTS TREATED WITH ICLUSIG. HEPATOTOXICITY, LIVER FAILURE AND DEATH OCCURRED IN PATIENTS TREATED WITH ICLUSIG. Excipients and allergens: see section 2 under 'Important information about some of this medicine's ingredients' and section 6 'Additional information'. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for your illness. Do not pass it on to others. It may harm them even if you think that their illness is the same as yours. This medicine is intended for use in adults above age 18 only. 1. WHAT IS THE MEDICINE INTENDED FOR? THIS MEDICINE IS INTENDED TO TREAT ADULTS with the following LEUKEMIA types, when other treatments are no longer effective or who have a genetic alteration known as a T315I mutation: • Chronic myeloid leukemia (CML) • קרא את המסמך השלם
1 PHYSICIAN PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT ICLUSIG 15 MG COATED TABLETS ICLUSIG 30 MG COATED TABLETS ICLUSIG 45 MG COATED TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Iclusig 15 mg film-coated tablets Each film-coated tablet contains 15 mg of ponatinib (as hydrochloride). _Excipients with known effect _ Each film-coated tablet contains 40 mg of lactose monohydrate. Iclusig 30 mg film-coated tablets Each film-coated tablet contains 30 mg of ponatinib (as hydrochloride). _Excipients with known effect _ Each film-coated tablet contains 80 mg of lactose monohydrate. Iclusig 45 mg film-coated tablets Each film-coated tablet contains 45 mg of ponatinib (as hydrochloride). _Excipients with known effect _ Each film-coated tablet contains 120 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Iclusig 15 mg film-coated tablets White, biconvex, round film-coated tablet that is approximately 6 mm in diameter, with "A5" debossed on one side. Iclusig 30 mg film-coated tablets White, biconvex, round film-coated tablet that is approximately 8 mm in diameter, with "C7" debossed on one side. Iclusig 45 mg film-coated tablets White, biconvex, round film-coated tablet that is approximately 9 mm in diameter, with “AP4” debossed on one side. WARNING: VASCULAR OCCLUSION, HEART FAILURE, AND HEPATOTOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING _ VASCULAR OCCLUSION: ARTERIAL AND VENOUS THROMBOSIS AND OCCLUSIONS HAVE OCCURRED IN AT LEAST 27% OF ICLUSIG TREATED PATIENTS, INCLUDING FATAL MYOCARDIAL INFARCTION, STROKE, STENOSIS OF LARGE ARTERIAL VESSELS OF THE BRAIN, SEVERE PERIPHERAL VASCULAR 2 DISEASE, AND THE NEED FOR URGENT REVASCULARIZATION PROCEDURES. PATIENTS WITH AND WITHOUT CARDIO VASCULAR RISK FACTORS, INCLUDING PATIENTS LESS THAN 50 YEARS OLD, EXPERIENCED THESE EVENTS. MONITOR FOR EVIDENCE OF THROMBOEMBOLISM AND VASCULAR OCCLUSION. INTERRUPT OR STOP ICLUSIG IMMEDIATELY FOR VASCULAR OCCLUSION. HEA קרא את המסמך השלם