Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
warfarin (warfarin sodium)
Takeda Pharma Sp.z o.o.
B01AA03
warfarin (warfarin sodium)
2,5mg
tablets
(50) and (100) in plastic container, (50/1x50/) and (100/1x100/) in plastic container
Prescription
Registered
2022-05-16
_Clean_SmPC_Warfarin 2-5 mg - _ _Page 1 of _ _10 _ SUMMARY OF PRODUCT CHARACTERISTICS FOR WARFARIN STADA TABLETS 1. D.SP.NO. 02686 2. NAME OF THE MEDICINAL PRODUCT Warfarin STADA 3. QUALITATIVE AND QUANTITATIVE COMPOSITION Warfarin sodium 2.5 mg Excipient: lactose (50 mg). For the full list of excipients, see section 6.1. 4. PHARMACEUTICAL FORM Tablets. Light blue tablets with a marked cross. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of systemic embolism in rheumatic heart disease and atrial fibrillation. Prophy- laxis and treatment of venous thrombosis and pulmonary embolism. Transient cerebral ischaemic attacks. Prophylaxis of thromboembolism after insertion of prosthetic heart valve. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Warfarin should be administered orally once a day. The duration of treatment depends on the indication. ADULTS Whenever possible, base-line prothrombin time should be determined before the initial dose is given. An initial loading dose for warfarin is usually 10mg daily for adults, tailored to individual requirements for the desired degree of anticoagulant effect. The maintenance dose is usually started after 48 hours and depends upon the prothrombin time - reported as international normalised ratio (INR). Currently recommended ranges of therapeutic antico- agulation are the following: - Prophylaxis of deep-vein thrombosis including surgery in high risk patients: INR 2-2.5; - Prophylaxis in hip surgery and fractured femur operations, treatment of deep vein thrombosis, pulmonary and systemic embolism, prevention of venous thromboembo- lism in myocardial infarction, transient ischaemic attacks, mitral stenosis with embo- lism, tissue prosthetic heart valves: INR 2-3; _Clean_SmPC_Warfarin 2-5 mg _ _Page 2 of 10 _ - Recurrent deep-vein thrombosis and pulmonary embolism, mechanical prosthetic heart valves, arterial disease including myocardial infarction: INR 3-4.5. The daily maintenance dose, taken at the same time each day, is usually between 3 mg and 9 mg. In the early Прочитать полный документ