WARFARIN TEVA
Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Produktets egenskaber
(SPC)
27-04-2024
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Aktiv bestanddel:
WARFARIN SODIUM CLATHRATE
Tilgængelig fra:
Taro Pharmaceuticals UK Ltd.
Dosering:
6 Milligram
Lægemiddelform:
Tablets
Autorisation dato:
2008-07-25
Produktets egenskaber
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Warfarin Teva 6 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains warfarin sodium clathrate equivalent to 6 mg warfarin sodium.
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Teal, flat, capsule shaped, scored tablet with ‘WARFARIN’ on top of ‘TARO’ engraved on one side and ‘6’ on the
other side.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
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).
War
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