CLEXANE 40 INJECTION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Sanofi-Aventis South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

INJECTION

Composition:

EACH 0,4 ml SOLUTION CONTAINS ENOXAPARIN 40 mg

Authorization status:

Registered

Authorization date:

1991-02-08

Patient Information leaflet

Page 1 of 6
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you are given CLEXANE.

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or
pharmacist.

CLEXANE has been prescribed for you personally.
SCHEDULING STATUS:
S4
NAME OF MEDICINAL PRODUCT:
CLEXANE
 20 (Injection)
CLEXANE
 40 (Injection)
CLEXANE
 60 (Injection)
CLEXANE

80 (Injection)
CLEXANE

100 (Injection)
CLEXANE

300 (Injection)
WHAT CLEXANE CONTAINS
The active ingredient in CLEXANE is enoxaparin sodium.
Each prefilled syringe contains:
CLEXANE 20: 20 mg enoxaparin sodium per 0,2 ml
CLEXANE 40: 40 mg enoxaparin sodium per 0,4 ml
CLEXANE 60: 60 mg enoxaparin sodium per 0,6 ml
CLEXANE 80: 80 mg enoxaparin sodium per 0,8 ml
CLEXANE 100: 100 mg enoxaparin sodium per 1,0 ml
The only other ingredient in the prefilled syringes is: water for
injection.
The multidose vial contains:
CLEXANE 300: 300 mg enoxaparin sodium per 3 ml.
The other ingredients in the multidose vial are: benzyl alcohol
(preservative) and water for
injection.
WHAT CLEXANE IS USED FOR
Page 2 of 6
CLEXANE is one of a group of medicines called low molecular weight
heparins (LMWH). These
medicines work by reducing blood clotting activity.
CLEXANE is used in a number of medical conditions. It is used to:

treat blood clots in veins

treat certain types of heart disease (e.g. angina and heart attacks),
when used with aspirin

prevent blood clots forming after an operation, during hospitalisation
or extended bed rest or
during purification of the blood by an artificial kidney
(haemodialysis).
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CLEXANE HAS BEEN
PRESCRIBED FOR
YOU.
CLEXANE is only available with a doctor’s prescription.
BEFORE YOU USE CLEXANE
YOU SHOULD NOT RECEIVE CLEXANE IF YOU HAVE OR HAVE EVER HAD:

an allergy to CLEXANE, heparin or its derivatives including other
LMWHs or benzyl
alcohol. Some signs and symptoms of an allergic reaction can include
swelling o

Summary of Product characteristics

Page 1 of 16
SCHEDULING STATUS:
S4
PROPRIETARY NAME AND DOSAGE FORM:
CLEXANE

20 (Injection)
CLEXANE

40 (Injection)
CLEXANE

60 (Injection)
CLEXANE

80 (Injection)
CLEXANE

100 (Injection)
CLEXANE

300 (Injection)
COMPOSITION:
CLEXANE
20: Enoxaparin sodium 20 mg per 0,2 ml
CLEXANE
40: Enoxaparin sodium 40 mg per 0,4 ml
CLEXANE
60: Enoxaparin sodium 60 mg per 0,6 ml
CLEXANE
80: Enoxaparin sodium 80 mg per 0,8 ml
CLEXANE
100: Enoxaparin sodium 100 mg per 1,0 ml
CLEXANE
300: Per multidose vial:
Enoxaparin sodium 300 mg
Benzyl alcohol (preservative) 1,5 % m/v
Water for injection to 3,0 ml
PHARMACOLOGICAL CLASSIFICATION:
A 8.2 Anticoagulants
PHARMACOLOGICAL ACTION:
Enoxaparin sodium is a low molecular weight heparin which has a
greater antithrombotic
(anti-
Factor Xa) activity than a thrombolytic effect (anti-Factor IIa
activity)_ in vivo_.
It is well absorbed after subcutaneous injection, with a half-life of
the anti-Factor Xa
activity of
4,5 hours. This is increased to 6,7 hours in the elderly.
The anti-Factor Xa activity disappears within 24 hours after
administration of the
recommended
dose.
Page 2 of 16
Heparins are metabolised in the liver by the enzyme heparinase. The
heparin half-life is
significantly prolonged in patients with cirrhosis of the liver.
A 30 mg IV bolus immediately followed by a 1 mg/kg SC every 12 hours
provided initial
peak
anti-Factor Xa levels of 1,16 IU/ml and average exposure corresponding
to 88 % of steady-state
levels. Steady-state is achieved on the second day of treatment.
_CHARACTERISTICS IN SPECIAL POPULATIONS: _
ELDERLY: Since renal function is known to decline with age, elderly
patients may show
reduced
elimination of enoxaparin sodium (refer to Special Precautions –
Haemorrhage in
the elderly;
DOSAGE AND DIRECTIONS FOR USE – Elderly & Pharmacological Action -
Renal
impairment).
RENAL IMPAIRMENT: A linear relationship between anti-Xa plasma
clearance and creatinine
clearance at steady-state has been observed, which indicates decreased
clearance of
enoxaparin