WARFARIN TEVA
מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
מאפייני מוצר
(SPC)
09-05-2024
מסמכים מסוימים עבור מוצר זה אינם זמינים כרגע, אתה יכול לשלוח בקשה לשירות הלקוחות שלנו ואנחנו נודיע לך ברגע שנוכל להשיג אותם.
שלח בקשה.
שלח בקשה.
מרכיב פעיל:
WARFARIN SODIUM CLATHRATE
זמין מ:
Taro Pharmaceuticals UK Ltd.
כמות:
0.5 Milligram
טופס פרצבטיות:
Tablets
תאריך אישור:
2008-07-25
מאפייני מוצר
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Warfarin Teva 0.5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains warfarin sodium clathrate equivalent to 0.5mg warfarin sodium.
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Oblong, flat, white tablet with ‘WARFARIN’ engraved on one side and ‘TARO 0.5’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of venous thrombosis and pulmonary embolism, and for use in the treatment of these conditions to prevent
their extension.
Prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Warfarin Tablets are for oral administration.
Adults: The usual induction dose of warfarin is 10mg daily for 2 days, but this should be tailored to individual
requirements. A baseline coagulation screen and liver function tests should be performed before initiating warfarin
therapy. Subsequent daily doses should be adjusted according to the results of the prothrombin time, usually reported as
the INR (international normalised ratio).
The daily maintenance dose of warfarin is usually in the range 3 to 9mg, taken at the same time each day. The
maintenance dose is omitted if the INR is excessively high.
Elderly patients: The elderly are generally more sensitive to the effects of warfarin and often require a smaller dose on
a weight-for-weight basis than younger patients.
Children: The safety and efficacy of warfarin in children have not been established.
4.3 CONTRAINDICATIONS
Pregnancy (see section 4.6 Pregnancy and lactation).
Warfarin should not be given within 3 days of surgery.
Known hypersensitivity to warfarin or to any of the excipients.
Use of herbal prepa
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