Warfarin Nycomed tablets

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

warfarin (warfarin sodium)

Dostopno od:

Takeda Pharma Sp.z o.o.

Koda artikla:

B01AA03

INN (mednarodno ime):

warfarin (warfarin sodium)

Odmerek:

2,5mg

Farmacevtska oblika:

tablets

Enote v paketu:

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

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2017-08-28

Lastnosti izdelka

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_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.
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_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