CLEXANE enoxaparin sodium 60mg/0.6mL injection syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

enoxaparin sodium, Quantity: 60 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; nitrogen

Administration route:

Subcutaneous, Extracorporeal Circulation - Haemodialysis

Units in package:

10 x 0.6mL prefilled syringe, 6 x 0.6mL prefilled syringe, 15 x 0.6mL prefilled syringe, 1 x 0.6mL prefilled syringe

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prevention of thrombo-embolic disorders of venous origin in patients undergoing orthopaedic and general surgery. Prophylaxis of venous thromboembolism in medical patients bedridden due to acute illness. Prevention of thrombosis in extra-corporeal circulation during haemodialysis. Treatment of established deep vein thrombosis. Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin. Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI) as an adjunctive to thrombolytic treatment, including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).

Product summary:

Visual Identification: Clear, colourless to pale yellow solution.; Container Type: Syringe; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1996-11-01

Patient Information leaflet

CLEXANE
® AND CLEXANE
® FORTE*
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CLEXANE?
Clexane contains the active ingredient enoxaparin sodium. Clexane is
used to prevent clots from getting bigger or stopping new
clots from forming following hospital procedures or illness. Clexane
is also used to treat DVT and heart problems including unstable
angina and heart attack when taken with aspirin. Clexane is used to
stop blood clots forming in the tubes of your kidney dialysis
machine.
For more information, see Section 1. Why am I using Clexane? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CLEXANE?
Do not use if you have ever had an allergic reaction to Clexane,
heparin or any medicine derived from heparin, or any of the
ingredients listed at the end of the CMI. Do not take Clexane if you
have or have had major bleeding disorders, injury to the brain,
stomach or bowel problems, or bacterial infections of the heart.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Clexane? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Clexane and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE CLEXANE?
•
Your doctor will decide what dose you will receive.
•
Clexane is usually administered by injection under the skin. It can
also be injected into the tubing of a dialysis machine or into a
vein by a doctor or nurse.
More instructions and how to use Clexane can be found in Section 4.
How do I use Clexane? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CLEXANE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, or pharmacist you

Summary of Product characteristics

clexane-ccdsv13-piv27-27aug20
Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION – CLEXANE AND
CLEXANE FORTE (ENOXAPARIN SODIUM)
1
NAME OF THE MEDICINE
Enoxaparin sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CLEXANE
Ready-to-use, prefilled syringes:
20 mg injection: enoxaparin sodium 20 mg/0.2 mL (anti-Xa: 2,000 IU)
40 mg injection: enoxaparin sodium 40 mg/0.4 mL (anti-Xa: 4,000 IU)
Ready-to-use, prefilled syringes with graduated markings:
60 mg injection: enoxaparin sodium 60 mg/0.6 mL (anti-Xa: 6,000 IU)
80 mg injection: enoxaparin sodium 80 mg/0.8 mL (anti-Xa: 8,000 IU)
100 mg injection: enoxaparin sodium 100 mg/1 mL (anti-Xa: 10,000 IU)
CLEXANE (WITH SAFETY LOCK SYSTEM)
Ready-to-use, prefilled syringes:
20 mg injection: enoxaparin sodium 20 mg/0.2 mL (anti-Xa: 2,000 IU)
40 mg injection: enoxaparin sodium 40 mg/0.4 mL (anti-Xa: 4,000 IU)
Ready-to-use, prefilled syringes with graduated markings
60 mg injection: enoxaparin sodium 60 mg/0.6 mL (anti-Xa: 6,000 IU)
80 mg injection: enoxaparin sodium 80 mg/0.8 mL (anti-Xa: 8,000 IU)
100 mg injection: enoxaparin sodium 100 mg/1 mL (anti-Xa: 10,000 IU)
CLEXANE FORTE
Ready-to-use, prefilled syringes with double graduated markings:
120 mg injection: 120 mg/0.8 mL (anti-Xa: 12,000 IU)
150 mg injection: 150 mg/1 mL (anti-Xa: 15,000 IU)
clexane-ccdsv13-piv27-27aug20
Page 2 of 27
CLEXANE FORTE (WITH SAFETY LOCK SYSTEM)
Ready-to-use, prefilled syringes with double graduated markings:
120 mg injection: 120 mg/0.8 mL (anti-Xa: 12,000 IU)
150 mg injection: 150 mg/1 mL (anti-Xa: 15,000 IU)
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
Injection, solution
Clear, colourless to pale yellow solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Prevention of thrombo-embolic disorders of venous origin in patients
undergoing
orthopaedic and general surgery.
•
Prophylaxis of venous thromboembolism in medical patients bedridden
due to acute
illness.
•
Prevention of thrombosis in extra-corporeal circulation during
haemodialysis.
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