ORFARIN 5MG TABLET

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Δραστική ουσία:

WARFARIN SODIUM

Διαθέσιμο από:

ORION PHARMA (MY) SDN. BHD.

INN (Διεθνής Όνομα):

WARFARIN SODIUM

Μονάδες σε πακέτο:

100 Tablets

Κατασκευάζεται από:

ORION CORP

Φύλλο οδηγιών χρήσης

_CONSUMER_
_ _
_MEDICATION_
_ _
_INFORMATION_
_ _
_LEAFLET_
_ _
_(RIMUP)_
_ _
ORFARIN TABLET
Warfarin Sodium (3mg and 5mg)
1
WHAT IS IN THIS LEAFLET
1.
What Orfarin is used for
2.
How Orfarin works
3.
Before you use Orfarin
4.
How to use Orfarin
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Orfarin
8.
Product
Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT ORFARIN IS USED FOR
Orfarin
tablets
are
used
to
prevent
thromboembolism (blood clots) or to treat
thromboembolism or its complications.
Orfarin tablets reduce the tendency of
blood to form clots.
Your doctor will explain to you, what
disease is treated or prevented by this
medicine. Most commonly, this
medicine is used to:
•
prevent
and
treat
deep
venous
thrombosis of the lower limbs (blood
clots in the blood vessels of lower
limbs)
and
pulmonary
embolism
(blood clots in the blood vessels of
the lung)
•
prevent
formation
of
blood
clots
during
rapid
and
irregular
heart
beating
•
prevent formation or reoccurrence of
blood clots after heart attack
•
prevent
formation
of
blood
clots
after heart valve replacement.
HOW ORFARIN WORKS
Orfarin belongs to a group of medicine
called anticoagulants.
These medicines increase the time it takes
for your blood to clot.
BEFORE YOU USE ORFARIN
-
_When you must not use it _
DO NOT USE ORFARIN IF YOU:
•
are in the first trimester and last four
weeks of pregnancy.
•
suffer
from
a
bleeding
tendency
(haemophilia,
von
Willebrand
disease, deficiency of blood platelets
(thrombocytopenia)
or
platelet
function deficit)
•
suffer from severe liver insufficiency
or liver cirrhosis
•
suffer
from
untreated
high
blood
pressure
•
have had recent intracranial bleeding
•
have tendency to frequent falls due to
neurological or other health- related
conditions
•
have had the surgery of the central
nervous system or the eye recently or
if you may undergo such surgery in
the near future
•
suffer
from
endocarditis
(inflammation of the inner layer of the
heart,
the
endoc

Αρχείο Π.Χ.Π.

1. NAME OF THE MEDICINAL PRODUCT
ORFARIN TABLET 3MG
ORFARIN 5MG TABLET
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Warfarin sodium 3 mg/tablet
Warfarin sodium 5 mg/tablet
Excipients: Orfarin (3 mg) tablet contains
lactose monohydrate equivalent to 85.1 mg
lactose.
Orfarin (5 mg) tablet contains lactose
monohydrate equivalent to 84.6 mg lactose.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
ORFARIN TABLET 3MG: Light blue or light
blue may be spotted, flat bevelled edged and
scored uncoated tablets with a diameter of
7 mm and code ORN 17.
ORFARIN 5MG TABLET: Pink or pink may
be spotted, , flat bevelled edged and scored
uncoated tablets with a diameter of 7 mm and
code ORN 18.
4. CLINICAL PARTICULARS
4.1. INDICATIONS
Treatment and prevention of deep venous
thrombosis and pulmonary embolism.
Prevention of thromboembolic complications
(stroke or systemic embolism) after myocardial
infarct.
Prevention of thromboembolic
complications(stroke or systemic embolism) in
patients with atrial fibrillation, cardiac valvular
disease or prosthetic heart valves.
4.2. POSOLOGY AND METHOD OF
ADMINISTRATION
The target INR range of oral anticoagulant
therapy:
Prophylaxis of thromboembolic complications
in patients with prosthetic heart valves: INR
2.5-3.5
Other indications: INR 2.0-3.0
Adults:
Patients in normal weight and the
spontaneous INR under 1.2 are administered
10 mg of warfarin on three consecutive days.
The dosing is continued according to the table
below, based on the INR-measured on the
fourth day.
In open care and for patients with inherited
protein C or protein S deficiency the
recommended initial dose is 5 mg of warfarin
(*) in three days. The dosing is continued
according to the table below, based on the
INR-measured on the fourth day.
For elderly patients, for those small in size,
for those with the spontaneous INR over
1.2, or for those who have a disease (see
Special warnings and special precautions
for use) or medication (see Interaction with
other medicinal products and other forms
of intera