Marevan

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Warfarin sodium 3mg

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Warfarin sodium 3 mg

Dosage:

3 mg

Pharmaceutical form:

Tablet

Composition:

Active: Warfarin sodium 3mg Excipient: Indigo carmine Lactose monohydrate Magnesium stearate Maize starch Pregelatinised maize starch Sodium starch glycolate

Units in package:

Bottle, plastic, 1 x 100, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Chemoswed AB

Therapeutic indications:

Coronary occlusion; deep vein thrombosis; pulmonary embolism; peripheral vascular thromboembolic states.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, - 100 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Patient Information leaflet

MAREVAN™ Tablets
1
MAREVAN™ Tablets
Warfarin Tablets 1 mg, 3 mg and 5 mg
New Zealand Consumer Medicine Information
What is in this leaflet
Please read this leaflet carefully
before you start using MAREVAN.
This leaflet answers some common
questions about MAREVAN. 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 MAREVAN
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 MAREVAN
Tablets are used for
MAREVAN is used for the treatment
and management of conditions
whereby the formation of blood clots
has prevented free-flow of blood,
especially in the veins.
Blood clots in the body can reduce
the amount of oxygen and nutrients
delivered to body tissues and organs
as well as affect the removal of waste
from tissues and organs. This affects
body functions.
MAREVAN contains an active
ingredient called warfarin. It is a
synthetic, anticoagulant agent which
belongs to the coumarin family of
anticoagulants. Some people refer to
anticoagulants as "blood thinners".
Anticoagulants decrease the clotting
ability of the blood and help prevent
a harmful clot (thrombus) from
forming in the blood vessels.
Anticoagulants are used as treatment
for certain blood vessel, heart and
lung conditions.
MAREVAN interferes with the
function of certain factors, which are
responsible for blood clotting.
These factors require a vitamin called
Vitamin K in order to function. The
amount of Vitamin K in your body
influences how well your blood clots.
Your doctor or pharmacist may
advise you on your diet as some
foods such as large amounts of leafy
green vegetables, dairy products
fortified with vitamin K, fats and
oils, contain vitamin K.
MAREVAN tablets are used in
conditions such as:

Coronary occlusions (blockage
in blood vesse

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
MAREVAN Warfarin sodium Tablets 1 mg, 3 mg and 5 mg
MAREVAN Warfarin sodium Tablets are not substitutable for any other
warfarin
product as if the two products were bioequivalent.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MAREVAN Tablet 1 mg:. Each tablet contains 1 mg warfarin sodium.
MAREVAN Tablet 3 mg: Each tablet contains 3 mg warfarin sodium.
MAREVAN Tablet 5 mg: Each tablet contains 5 mg warfarin sodium.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tablet
MAREVAN Tablet 1 mg: brown uncoated round flat bevelled edge tablet, 8
mm in
diameter and 2 mm deep, engraved DF/M1 on one side.
MAREVAN Tablet 3 mg: pale blue uncoated round flat bevelled edge
tablet, 8 mm in
diameter and 2 mm deep, engraved DF/M3 on one side.
MAREVAN Tablet 5 mg: pink uncoated round flat bevelled edge tablet, 8
mm in
diameter and 2 mm deep, engraved DF/M5 on one side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic Indications
Coronary occlusion; deep vein thrombosis; pulmonary embolism;
peripheral vascular
thromboembolic states; mesenteric and retinal thromboembolism.
In emergencies, such as the conditions listed above, anticoagulant
therapy should be
initiated with heparin and MAREVAN together. Where there is less
urgency, as in
patients disposed to or at special risk of thromboembolism,
anticoagulant therapy
may be initiated with MAREVAN alone. Appropriate indications include
predisposition
to thromboembolism following surgery and chronic embolic pulmonary
hypertensive
disease.
4.2
Dosage and method of administration
Dose
10 to 15 mg daily, according to age and body weight, and adjusted with
relation to
the results of daily control tests until the desired level of
anticoagulant activity is
achieved - usually three to six days after the initiation of
treatment.
2
Control tests should be made at regular intervals and the MAREVAN
maintenance
dosage must be adjusted according to the results obtained.
Concomitant heparin therapy affects the results of contro