Krajina: Arménsko
Jazyk: angličtina
Zdroj: 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
2017-08-28
_ _ _ _ _Clean_SmPC_Warfarin 2-5 mg -_ _Page 1 of 13 _ 02 MAY 2018 SUMMARY OF PRODUCT CHARACTERISTICS FOR WARFARIN NYCOMED TABLETS 0. D.SP.NO. 02686 1. NAME OF THE MEDICINAL PRODUCT Warfarin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Warfarin sodium 2.5 mg Excipient: lactose (50 mg). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Light blue tablets with a marked cross. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prevention of blood vessels thrombosis and embolism: acute and relapsing venous thrombosis, pulmonary artery embolism; secondary prevention of myocardial in- farction and prevention of thromboembolic complications after myocardial infarction; pre- vention of thromboembolic complications in patients, atrial fibrillation valvular disease or prosthetic heart valves; treatment and prevention of transient ischemic attacks and strokes; prevention of postoperative thrombosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Warfarin should be administered once a day. The duration of treatment depends on the in- dication. ADULTS Patients who have not previously been treated with warfarin: The recommended starting dose is 2 tablets (5 mg) once daily for 4 days. On day 5 INR is measured and then the dose is adjusted individually. The usual maintenance dose is 2.5-7.5 mg daily (1-3 tablets daily). In patients who have previously been treated with warfarin, it is recommended to start with a double dose of the previous maintenance dose for 2 days, and to continue with the prior maintenance dose until the first INR measurement on day 5. _ _ _ _ _Clean_SmPC_Warfarin 2-5 mg -_ _Page 2 of 13 _ Loading doses higher than those listed are not recommended and in most clinical situations not justified. Higher loading doses do not lead to reaching an anticoagulant effect faster, but instead in an increased risk of bleeding. Control of anticoagulant treatment: Coagulation tests should be performed before starting treatment. Warfarin has a narrow therapeutic index and warfarin se Prečítajte si celý dokument