COUMADIN 6 MG

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

WARFARIN SODIUM

Διαθέσιμο από:

TARO PHARMACEUTICAL INDUSTRIES LTD

Φαρμακολογική κατηγορία (ATC):

B01AA03

Φαρμακοτεχνική μορφή:

TABLETS

Σύνθεση:

WARFARIN SODIUM 6 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

TARO PHARMACEUTICAL INDUSTRIES LTD

Θεραπευτική ομάδα:

WARFARIN

Θεραπευτική περιοχή:

WARFARIN

Θεραπευτικές ενδείξεις:

Coumadin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonar embolis. Coumadin is indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. Coumadin is indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.

Ημερομηνία της άδειας:

2023-06-30

Αρχείο Π.Χ.Π.

Final Physician Leaflet 08.2020
1
PRESCRIBING INFORMATION
COUMADIN TABLETS
1. NAME OF THE MEDICINAL PRODUCT
COUMADIN 1 mg
COUMADIN 2 mg
COUMADIN 2.5 mg
COUMADIN 5 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Coumadin 1 mg contains 1 mg warfarin sodium.
Each tablet of Coumadin 2 mg contains 2 mg warfarin sodium.
Each tablet of Coumadin 2.5 mg contains 2.5 mg warfarin sodium.
Each tablet of Coumadin 5 mg contains 5 mg warfarin sodium.
For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Tablets.
Presentation:
COUMADIN 1 mg tablets are pink, flat capsule shaped, beveled tablets,
one side engraved
with “WARFARIN” and "TARO", and other side scored and engraved
with “1”.
COUMADIN 2 mg tablets are lavender, flat capsule shaped, beveled
tablets, one side
engraved with “WARFARIN” and "TARO", and other side scored and
engraved with “2”.
COUMADIN 2.5 mg tablets are green, flat capsule shaped, beveled
tablets, one side
engraved with “WARFARIN” and "TARO", and other side scored and
engraved with “2½”.
COUMADIN 5 mg tablets are peach, flat capsule shaped, beveled tablets,
one side engraved
with “WARFARIN” and "TARO", and other side scored and engraved
with “5”.
The tablet can be divided into equal halves.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
COUMADIN is indicated for the prophylaxis and/or treatment of venous
thrombosis and its
extension, and pulmonary embolism.
COUMADIN is indicated for the prophylaxis and/or treatment of the
thromboembolic
complications associated with atrial fibrillation and/or cardiac valve
replacement.
COUMADIN is indicated to reduce the risk of death, recurrent
myocardial infarction, and
thromboembolic events such as stroke or systemic embolization after
myocardial infarction.
Final Physician Leaflet 08.2020
2
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage and administration of COUMADIN must be individualized for
each patient
according to the particular patient's PT/INR response to the drug. The
dosage should be
adjusted based upon the pat