INHIXA 2000iu0.2ML SOLUTION FOR INJECTION IN PREFILLED SYRINGE

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

ENOXAPARIN SODIUM

Dostępny od:

MEDISPEC (M) SDN.BHD

INN (International Nazwa):

ENOXAPARIN SODIUM

Sztuk w opakowaniu:

2 Pre-Filled Syringes; 2 Pre-Filled Syringes; 10 Pre-Filled Syringes; 10 Pre-Filled Syringes

Wyprodukowano przez:

Shenzhen Techdow Pharmaceutical Co., Ltd.

Charakterystyka produktu

INHIXA 2,000 IU (20 MG)/0.2 ML
INHIXA 4,000 IU (40 MG)/0.4 ML
INHIXA 6,000 IU (60 MG)/0.6 ML
enoxaparin sodium
SOLUTION FOR INJECTION IN PREFILLED SYRINGE
The package insert is continually updated: please read carefully
before using a new pack. In case of
any question, please contact your physician or pharmacist.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: enoxaparin sodium
Solvent: water for injections.
Each ml of the solution contains 10000 IU anti-Xa activity equivalent
to 100 mg enoxaparin sodium.
One mg (0.01 ml) of enoxaparin sodium corresponds approximately to 100
IU anti-Xa activity.
Inhixa 2000 IU anti-Xa activity is equivalent to 20 mg,
Inhixa 4000 IU anti-Xa activity is equivalent to 40 mg,
Inhixa 6000 IU anti-Xa activity is equivalent to 60 mg.
PRODUCT DESCRIPTION
A clear, colourless or pale yellow solution IN READY-TO-USE PRE-FILLED SYRINGE
•
Inhixa is a biosimilar medicine to the reference product Clexane
(Enoxaparin Sodium).
•
Inhixa is not interchangeable or automatically substitutable with
Clexane.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Inhixa is indicated in adults for:
_ _
•
Prophylaxis of venous thromboembolic disease in moderate and high risk
surgical patients, in
particular those undergoing orthopaedic or general surgery including
cancer surgery.
•
Prophylaxis of venous thromboembolic disease in medical patients with
an acute illness (such as
acute heart failure, respiratory insufficiency, severe infections or
rheumatic diseases) and reduced
mobility at increased risk of venous thromboembolism.
•
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
excluding PE likely to
require thrombolytic therapy or surgery.
•
Prevention of thrombus formation in extra corporeal circulation during
haemodialysis.
•
Acute coronary syndrome:
-
Treatment
of
unstable
angina
and
Non
ST-segment
elevation
myocardial
infarction
(NSTEMI), in combination with oral acetylsalicylic acid.
-
Treatment of acute ST-segment elevation myocardial infarction (STEMI)
including