CLEXANE

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

ENOXAPARIN SODIUM

Tilgjengelig fra:

SANOFI ISRAEL LTD

ATC-kode:

B01AB05

Legemiddelform:

SOLUTION FOR INJECTION

Sammensetning:

ENOXAPARIN SODIUM 100 MG/ML ML

Administreringsrute:

I.V, S.C, EXTRACORPOREAL

Resept typen:

Required

Produsert av:

SANOFI WINTHROP INDUSTRIE, FRANCE

Terapeutisk gruppe:

ENOXAPARIN

Terapeutisk område:

ENOXAPARIN

Indikasjoner:

Clexane 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 patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).

Autorisasjon dato:

2015-02-28

Preparatomtale

1
Clexane - SPC - 11.1
1.
NAME OF THE MEDICINAL PRODUCT
-
Clexane 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled
syringes
-
Clexane 4,000 IU (40 mg)/0.4 mL solution for injection in pre-filled
syringes
-
Clexane 6,000 IU (60 mg)/0.6 mL solution for injection in pre-filled
syringes
-
Clexane 8,000 IU (80 mg)/0.8 mL solution for injection in pre-filled
syringes
-
Clexane 10,000 IU (100 mg)/1 mL solution for injection in pre-filled
syringes
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10,000 IU/mL (100 mg/mL) solution for injection
_2,000 IU (20 mg) /0.2 mL_
Each pre-filled syringe contains enoxaparin sodium 2,000 IU anti-Xa
activity (equivalent to 20 mg) in
0.2 mL water for injections.
_ _
_4,000 IU (40 mg) /0.4 mL_
Each pre-filled syringe contains enoxaparin sodium 4,000 IU anti-Xa
activity (equivalent to 40 mg) in
0.4 mL water for injections.
_ _
_6,000 IU (60 mg) /0.6 mL_
Each pre-filled syringe contains enoxaparin sodium 6,000 IU anti-Xa
activity (equivalent to 60 mg) in
0.6 mL water for injections.
_ _
_8,000 IU (80 mg) /0.8 mL_
Each pre-filled syringe contains enoxaparin sodium 8,000 IU anti-Xa
activity (equivalent to 80 mg) in
0.8 mL wat
er for injections.
_ _
_10,000 IU (100 mg) /1.0 mL_
Each pre-filled syringe contains enoxaparin sodium 10,000 IU anti-Xa
activity (equivalent to 100 mg)
in 1.0
mL water for injections.
For the full list of excipients, see section 6.1.
Enoxaparin sodium is a biological substance obtained by alkaline
depolymerization of heparin benzyl
ester
derived from porcine intestinal mucosa.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringes.
Clear, colourless to yellowish solution, pH-value 5.5–7.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clexane syringes are 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