Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Warfarin sodium 5mg
Viatris Limited
Warfarin sodium 5 mg
5 mg
Tablet
Active: Warfarin sodium 5mg Excipient: Brilliant blue FCF Lactose Magnesium stearate Maize starch Quinoline yellow Stearic acid
Blister pack, 50 tablets
Prescription
Prescription
Chemoswed AB
COUMADIN is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, thromboembolism associated with atrial fibrillation, and as an adjunct in the prophylaxis of systemic embolism after myocardial infarction.
Package - Contents - Shelf Life: Blister pack, - 50 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, glass, - 50 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, HDPE with Clic loc II 33 mm child resistant cap - 50 tablets - 36 months from date of manufacture stored at or below 30°C protect from light
1991-10-09
Page 1 of 5 NEW ZEALAND CONSUMER MEDICINE INFORMATION COUMADIN ® _WARFARIN SODIUM TABLETS 1MG, 2 MG AND 5 MG._ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Coumadin. This leaflet answers some common questions about Coumadin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Coumadin against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT COUMADIN IS USED FOR Coumadin contains an active ingredient called “warfarin”. It helps to prevent blood from excessive clotting or forming harmful clots. This medicine belongs to a group of medicines called anticoagulants. Some people refer to anticoagulants as ‘blood thinners’. Excessive clotting sometimes occurs when physical mobility is low. If excessive clotting is not treated, it can lead to serious health problems such as strokes or heart attacks. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY COUMADIN HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Coumadin for another reason. THERE ARE OTHER BRANDS OF WARFARIN TABLETS. DO NOT CHANGE FROM ONE BRAND TO THE OTHER WITHOUT TALKING TO YOUR DOCTOR OR PHARMACIST. IT MAY NOT BE SAFE TO CHANGE AND DO NOT COMBINE DIFFERENT BRANDS TOGETHER. There is no evidence that Coumadin is addictive. Coumadin is available only with a doctor’s prescription. BEFORE YOU USE COUMADIN _WHEN YOU MUST NOT TAKE _ _IT_ DO NOT TAKE COUMADIN DURING PREGNANCY Taking Coumadin during pregnancy may harm the developing baby. If you are considering becoming pregnant while taking Coumadin, tell your doctor who can help you weigh the benefits of taking Coumadin against the possible risks. DO NOT TAKE COUMADIN IF YOU HAVE AN ALLERGY TO: • warfarin • any of the ingredients in Coumadin list Đọc toàn bộ tài liệu
Page 1 of 17 NEW ZEALAND DATA SHEET COUMADIN ® 1. PRODUCT NAME Coumadin 1 mg, 2 mg and 5 mg tablets Coumadin is not to be marketed as substitutable for any other warfarin product as if the two products were bioequivalent 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Coumadin tablet contains 1 mg, 2 mg or 5 mg of warfarin. Excipients with known effect: lactose and maize starch. Allergen declaration: Sulfites and sugars as lactose. For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Tablets, 1 mg - A light tan coloured biconvex tablet debossed with “Coumadin” above the line and “1” below the line on one side and plain on the other side. Tablets, 2 mg - A lavender coloured biconvex tablet debossed with “Coumadin” above the line and “2” below the line on one side and plain on the other side. Tablets, 5 mg - A green coloured biconvex tablet debossed with “Coumadin” above the line and “5” below the line on one side and plain on the other side. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Coumadin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, thromboembolism associated with atrial fibrillation, and as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ ADMINISTRATION: The administration and dosage of Coumadin must be individualised for each patient according to the particular patient's sensitivity to the drug. The dosage should be adjusted based upon the results of the one stage prothrombin time (PT). Different thromboplastin reagents vary substantially in their responsiveness to sodium warfarin-induced effects on prothrombin time. To define the appropriate therapeutic regimen, it is important to be familiar with the sensitivity of the thromboplastin reagent used in the laboratory and its relationship to the International Reference Preparation (IRP)*, a sensitive thromboplastin reagent prepared from human brain Page 2 of 17 * A Đọc toàn bộ tài liệu