CLEXANE 4000 IU (40 mg) 0.4 ML (PREFILLED SYRINGE FOR INJECTION)

País: Malásia

Língua: inglês

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

Ingredientes ativos:

ENOXAPARIN SODIUM (HEPARIN)

Disponível em:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

DCI (Denominação Comum Internacional):

ENOXAPARIN SODIUM (HEPARIN)

Unidades em pacote:

10 Pre-Filled Syringes; 2 Pre-Filled Syringes

Fabricado por:

SANOFI WINTHROP INDUSTRIE

Folheto informativo - Bula

Not Applicable

Características técnicas

MY/CLE/1121/CCDSv13
1
CLEXANE
® 2000 IU (20 MG)/0.2 ML
CLEXANE
® 4000 IU (40 MG)/0.4 ML
CLEXANE
® 6000 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 equivalent to 100 mg
enoxaparin sodium. One mg (0.01 ml) of
enoxaparin sodium corresponds approximately to 100 anti-Xa IU.
CLEXANE 2000 IU is equivalent to 20 mg,
CLEXANE 4000 IU is equivalent to 40 mg,
CLEXANE 6000 IU is equivalent to 60 mg.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Enoxaparin sodium 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.
•
Prevention of thrombus formation in extracorporeal circulation during
hemodialysis
_ _
•
Prophylaxis of venous thromboembolic disease in medical patients with
an acute illness (such as
acute heart failure , respiratory insufficiency, severe infection 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.
•
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 patients to be
managed medically or with subsequent Percutaneous Coronary
Intervention (PCI).
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Prophylaxis of venous thromboembolic disease in moderate and high
risk surgical patients _
Individual thromboembolic risk for patients can be estimated using
v