Coumadin

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Warfarin sodium 5mg

Dostupné z:

Viatris Limited

INN (Medzinárodný Name):

Warfarin sodium 5 mg

Dávkovanie:

5 mg

Forma lieku:

Tablet

Zloženie:

Active: Warfarin sodium 5mg Excipient: Brilliant blue FCF Lactose Magnesium stearate Maize starch Quinoline yellow Stearic acid

Počet v balení:

Blister pack, 50 tablets

Trieda:

Prescription

Typ predpisu:

Prescription

Výrobca:

Chemoswed AB

Terapeutické indikácie:

COUMADIN is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, thromboembolism associated with atrial fibrillation, and as an adjunct in the prophylaxis of systemic embolism after myocardial infarction.

Prehľad produktov:

Package - Contents - Shelf Life: Blister pack, - 50 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, glass, - 50 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, HDPE with Clic loc II 33 mm child resistant cap - 50 tablets - 36 months from date of manufacture stored at or below 30°C protect from light

Dátum Autorizácia:

1991-10-09

Príbalový leták

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
COUMADIN
®
_WARFARIN SODIUM TABLETS 1MG, 2 MG AND 5 MG._
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Coumadin.
This leaflet answers some common
questions about Coumadin.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Coumadin
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT COUMADIN IS
USED FOR
Coumadin contains an active
ingredient called “warfarin”. It helps
to prevent blood from excessive
clotting or forming harmful clots.
This medicine belongs to a group of
medicines called anticoagulants.
Some people refer to anticoagulants
as ‘blood thinners’. Excessive
clotting sometimes occurs when
physical mobility is low. If excessive
clotting is not treated, it can lead to
serious health problems such as
strokes or heart attacks.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY COUMADIN
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Coumadin for another reason.
THERE ARE OTHER BRANDS OF
WARFARIN TABLETS. DO NOT CHANGE
FROM ONE BRAND TO THE OTHER
WITHOUT TALKING TO YOUR DOCTOR OR
PHARMACIST. IT MAY NOT BE SAFE TO
CHANGE AND DO NOT COMBINE
DIFFERENT BRANDS TOGETHER.
There is no evidence that Coumadin
is addictive.
Coumadin is available only with a
doctor’s prescription.
BEFORE YOU USE
COUMADIN
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE COUMADIN DURING
PREGNANCY
Taking Coumadin during pregnancy
may harm the developing baby. If
you are considering becoming
pregnant while taking Coumadin,
tell your doctor who can help you
weigh the benefits of taking
Coumadin against the possible
risks.
DO NOT TAKE COUMADIN IF YOU
HAVE AN ALLERGY TO:
•
warfarin
•
any of the ingredients in
Coumadin list

Súhrn charakteristických

Page 1 of 17
NEW ZEALAND DATA SHEET
COUMADIN
®
1. PRODUCT NAME
Coumadin 1 mg, 2 mg and 5 mg tablets
Coumadin is not to be marketed as substitutable for any other warfarin
product as if the two products
were bioequivalent
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Coumadin tablet contains 1 mg, 2 mg or 5 mg of warfarin.
Excipients with known effect: lactose and maize starch.
Allergen declaration: Sulfites and sugars as lactose.
For the full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Tablets, 1 mg - A light tan coloured biconvex tablet debossed with
“Coumadin” above the line and
“1” below the line on one side and plain on the other side.
Tablets, 2 mg - A lavender coloured biconvex tablet debossed with
“Coumadin” above the line and
“2” below the line on one side and plain on the other side.
Tablets, 5 mg - A green coloured biconvex tablet debossed with
“Coumadin” above the line and “5”
below the line on one side and plain on the other side.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Coumadin is indicated for the prophylaxis and/or treatment of venous
thrombosis and its extension,
pulmonary embolism, thromboembolism associated with atrial
fibrillation, and as an adjunct in the
prophylaxis of systemic embolism after myocardial infarction.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
ADMINISTRATION:
The administration and dosage of Coumadin must be individualised for
each patient according to the
particular patient's sensitivity to the drug. The dosage should be
adjusted based upon the results of
the one stage prothrombin time (PT). Different thromboplastin reagents
vary substantially in their
responsiveness to sodium warfarin-induced effects on prothrombin time.
To define the appropriate
therapeutic regimen, it is important to be familiar with the
sensitivity of the thromboplastin reagent
used in the laboratory and its relationship to the International
Reference Preparation (IRP)*, a
sensitive thromboplastin reagent prepared from human brain
Page 2 of 17
* A