Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
ponatinib hydrochloride, Quantity: 48.1 mg (Equivalent: ponatinib, Qty 45 mg)
Takeda Pharmaceuticals Australia Pty Ltd
ponatinib hydrochloride
Tablet, film coated
Excipient Ingredients: magnesium stearate; sodium starch glycollate; lactose monohydrate; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350
Oral
Bottles of 30 tablets
(S4) Prescription Only Medicine
ICLUSIG is indicated for the treatment of adult patients with:,Chronic phase (CP), accelerated phase (AP), or blast phase (BP) chronic myeloid Ieukaemia (CML) whose disease is resistant to, or who are intolerant of at least two prior tyrosine kinase inhibitors; or where there is a T315I mutation.,Philadelphia chromosome positive acute lymphoblastic Ieukaemia (Ph+ ALL) whose disease is resistant to, or who are intolerant of dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or where there is a T315I mutation.,Therapy with ICLUSIG should be initiated and monitored by a haematologist with expertise in managing adult Ieukaemias.
Visual Identification: Tablets are white, biconvex, round film-coated tablets debossed with 'AP4' on one side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2014-11-26
ICLUSIG ® I C L U S I G C M I V 3 . 0 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. ▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I USING ICLUSIG? ICLUSIG contains the active ingredient ponatinib hydrochloride. ICLUSIG is used to treat adults with certain types of leukaemia. For more information, see Section 1. Why am I using ICLUSIG? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ICLUSIG? Do not use if you have ever had an allergic reaction to ICLUSIG or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use ICLUSIG? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with ICLUSIG and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE ICLUSIG? • You should follow all directions on how to use ICLUSIG given by your doctor or pharmacist More instructions can be found in Section 4. How do I use ICLUSIG? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ICLUSIG? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using ICLUSIG. If you are pregnant, intending to get pregnant or to father a child, tell your doctor immediately. THINGS YOU SHOULD NOT DO • Do not stop using this medicine without talking to your doctor first. DRIVING OR USING MACHINES • Be careful driving or operating machinery until you know how ICLUSIG affects you. DRINKING ALCOHOL • Tell your doctor if you have a history of alcohol abuse. LOOKING AF Đọc toàn bộ tài liệu
ICLUSIG PI V4.0 (CCDS V12.1) _ _ _1 _ AUSTRALIAN PRODUCT INFORMATION ICLUSIG ® (PONATINIB HYDROCHLORIDE) WARNING: ARTERIAL OCCLUSIVE EVENTS, VENOUS THROMBOEMBOLIC EVENTS, HEART FAILURE, HYPERTENSION AND HEPATOTOXICITY • ARTERIAL OCCLUSIVE EVENTS (AOES), INCLUDING FATALITY, HAVE OCCURRED IN ICLUSIG-TREATED PATIENTS. AOES INCLUDING FATAL MYOCARDIAL INFARCTION, STROKE, STENOSIS OF LARGE ARTERIAL VESSELS OF THE BRAIN, SEVERE PERIPHERAL VASCULAR DISEASE (SOMETIMES RESULTING IN AMPUTATION), VISION LOSS, AND THE NEED FOR URGENT REVASCULARISATION PROCEDURES. PATIENTS WITH AND WITHOUT CARDIOVASCULAR RISK FACTORS, INCLUDING PATIENTS LESS THAN 50 YEARS OLD, EXPERIENCED THESE EVENTS. MONITOR FOR EVIDENCE OF AOES. INTERRUPT OR STOP ICLUSIG BASED ON SEVERITY. CONSIDER BENEFIT-RISK TO GUIDE DECISION TO RESTART ICLUSIG • VENOUS THROMBOEMBOLIC EVENTS (VTES) HAVE OCCURRED IN ICLUSIG-TREATED PATIENTS. MONITOR FOR EVIDENCE OF VTES. INTERRUPT OR STOP ICLUSIG BASED ON SEVERITY. • HEART FAILURE, INCLUDING FATALITIES, OCCURRED IN ICLUSIG-TREATED PATIENTS. MONITOR CARDIAC FUNCTION. INTERRUPT OR STOP ICLUSIG FOR NEW OR WORSENING HEART FAILURE • HYPERTENSION, INCLUDING HYPERTENSIVE CRISIS, HAS BEEN OBSERVED IN ICLUSIG-TREATED PATIENTS. • HEPATOTOXICITY, INCLUDING LIVER FAILURE AND DEATH HAVE OCCURRED IN ICLUSIG-TREATED PATIENTS. MONITOR HEPATIC FUNCTION. INTERRUPT ICLUSIG BASED ON SEVERITY. SEE SECTION 4.4 SPECIAL WARNING AND PRECAUTIONS FOR USE – ARTERIAL OCCLUSION, VENOUS THROMBOEMBOLISM, HEART FAILURE, HYPERTENSION AND HEPATOTOXICITY 1 NAME OF THE MEDICINE Ponatinib (as hydrochloride) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains ponatinib hydrochloride equivalent to 10, 15, 30, or 45 mg ponatinib. Excipients with known effect: Lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM ICLUSIG tablets are available for oral administration. 10 mg Tablet: White to off-white, biconvex, oval film-coated tablet with “NZ” debossed on one side. 15 mg Tablet Đọc toàn bộ tài liệu