ARIXTRA 2.5MG0.5ML SOLUTION FOR INJECTION

Country: Malaysia

Language: English

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

Active ingredient:

FONDAPARINUX SODIUM

Available from:

Aspen Medical Products Malaysia Sdn Bhd

INN (International Name):

FONDAPARINUX SODIUM

Units in package:

0.5 ml 2 Units mL Pre-Filled Syringes; 0.5ml 10 Units mL Pre-Filled Syringes

Manufactured by:

Aspen Notre Dame De Bondeville

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
1
ARIXTRA
2.5 MG/0.5 ML SOLUTION
FOR INJECTION
Fondaparinux sodium (2.5 mg/0.5 ml)
WHAT IS IN THIS LEAFLET
1.
What ARIXTRA is used for
2.
How ARIXTRA works
3.
Before you use ARIXTRA
4.
How to use
ARIXTRA
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
ARIXTRA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ARIXTRA IS USED FOR
Arixtra is used to:
•
prevent the formation of blood
clots in the blood vessels of the
legs or lungs after orthopaedic
surgery (such as hip or knee
surgery) or abdominal surgery
•
prevent the formation of blood
clots during, and shortly after a
period of restricted movement
due to illness
•
treat some types of heart attack
or severe angina (pain caused
by narrowing of the arteries in
the heart)
HOW ARIXTRA WORKS
Arixtra is a medicine that helps to
prevent blood clots from forming
in the blood vessels (
_thromboses_
),
or treats blood clots if they have
already formed (
_an antithrombotic _
_agent_
). It does this by stopping a
clotting factor called Xa (“ten-A”)
from working in the blood.
BEFORE YOU USE ARIXTRA
-
_When you must not use it_
Do not use Arixtra:
•
if you are allergic
(
_hypersensitive_
) to fondaparinux
sodium or to any of the other
ingredients of Arixtra
•
if you are bleeding excessively
•
if you have a bacterial heart
infection
•
if you have severe kidney
impairment
Check with your doctor if you
think any of these may apply to
you.
Arixtra should not be prescribed
to pregnant women unless clearly
necessary. If you are pregnant, or
think you could be, tell your
doctor.
Breast-feeding is not
recommended during treatment
with Arixtra.
-
_Before you start to use it_
Before you are given Arixtra your
doctor needs to know:
•
if you have a risk of
uncontrolled bleeding
(
_haemorrhage_
) including:
-
stomach ulcer
-
bleeding disorders
-
recent bleeding in the brain
(
_intracranial bleeding_
)
-
recent surgery on the brain,
spine or eye
•
if yo

Summary of Product characteristics

- Arixtra Logo -
Fondaparinux sodium
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each syringe contains 2.5 mg of fondaparinux sodium in 0.5 ml solution for injection. The
solution is a clear and colourless liquid.
PHARMACEUTICAL FORM
Injectable solution for subcutaneous and intravenous use.
CLINICAL PARTICULARS
INDICATIONS
Prevention of Venous Thromboembolic Events (VT E) in patients undergoing major
orthopaedic surgery of the lower limbs such as:
• hip fracture;
• knee replacement surgery;
• hip replacement surgery.
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal
surgery who are at risk of thromboembolic complications.
Prevention of Venous Thromboembolic Events (VTE) in medical patients who are at risk of
thromb oembolic complications due to restricted mobility during acute illness.
Treatment of unstable angina or non -ST segment elevation myocardial infarction (UA/
NSTEMI) in patients for whom an urgent (< 120 mins) invasive management (PCI) is not
indicated ( see sections Warnings and Precautions & Pharmacological Properties ).
Treatment of ST segment elevation myocardial infarction (STEMI) in patients who are
managed with thrombolytics or who initially are to receive no other form of reperfusion therapy
( see sect ions Warnings and Precautions & Pharmacological Properties ).
DOSAGE AND ADMINISTRATION
METHOD OF ADMINISTRATION
Subcutaneous administration
The sites of subcutaneous injection should alternate between the left and the right
anterolateral and left and right posterolateral abdominal wall. To avoid the loss of medicinal
product when using the pre -filled syringe do not expel the air bubble from the syringe
before the injection. The whole length of the needle should be inserted perpendicularly into a
skin fold held between the thumb and the forefinger. The skin fold should be held throughout
the injection.
ARIXTRA is intended for use under a physician’s guidance. Patients may self -inject only if
their physician determines that it is appropriate, and with medical