Warfarin STADA tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

warfarin (warfarin sodium)

Available from:

Takeda Pharma Sp.z o.o.

ATC code:

B01AA03

INN (International Name):

warfarin (warfarin sodium)

Dosage:

2,5mg

Pharmaceutical form:

tablets

Units in package:

(50) and (100) in plastic container, (50/1x50/) and (100/1x100/) in plastic container

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-05-16

Summary of Product characteristics

_Clean_SmPC_Warfarin 2-5 mg - _
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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 _
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-
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