ARIXTRA 12.5MG/ML SOLUTION FOR INJECTION

Země: Malajsie

Jazyk: angličtina

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

Aktivní složka:

FONDAPARINUX SODIUM

Dostupné s:

Aspen Medical Products Malaysia Sdn Bhd

INN (Mezinárodní Name):

FONDAPARINUX SODIUM

Jednotky v balení:

0.4ml 2Units mL; 0.6ml 2Units mL; 0.6ml 10 Units mL; 0.4ml 10 Units mL

Výrobce:

Aspen Notre Dame De Bondeville

Informace pro uživatele

_Consumer Medication Information Leaflet (RiMUP)_
_ _
ARIXTRA 12.5 MG/ML SOLUTION FOR
INJECTION
Fondaparinux sodium (12.5 mg/ ml)
1
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

treat blood clots in blood
vessels that are deep in the legs
(deep vein thrombosis) or lungs
(pulmonary thrombosis)
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 you have had blood clotting
problems, or a reduction in the
number of cells necessary for
clotting after previous trea

Charakteristika produktu

CO NFIDENTIAL
1 ARIXTRA 5MG/0.4ML
ARIXTRA 7.5MG/0.6ML Fondaparinux sodium
QUALITATIVE AND Q UANTITATIVE CO MPOSITION
Sterile, pr eservative- free, clear and colourless t o slightly yellow, injectable
solution, i n a single dose pre- filled syringe.
Each syringe contains 5.0 mg o f fondaparinux so dium in 0.4 ml solution for
injection.
Each syringe contains 7.5 mg o f fondaparinux so dium in 0.6 ml solution for
injection.
PHARMACEUTICAL FORM
Injectabl e solution f or subcutaneous use .
CLINICAL PARTICULARS
Indications
Treatment o f a
cute De ep Vein Thrombosis (DVT).
Treatment of acute Pulmonary E mbolism (PE).
Dosage and Administration
Method of a dministration
Subcutaneous a dministration
The sites of administration shoul d alternate between the left an d the right
anterolateral and l eft and right posterolateral abdominal w all. To avoid the l oss of
medicinal pr oduct when using t he pre-filled syringe do not ex pel the ai r bubble
from t he syringe before the injection. The whole lengt h of the needle should be