ENOXAPARIN WINTHROP enoxaparin sodium 100 mg/1 mL injection syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

enoxaparin sodium

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Enoxaparin sodium

Authorization status:

Registered

Patient Information leaflet

ENOXAPARIN WINTHROP
AND ENOXAPARIN
WINTHROP FORTE*
_enoxaparin sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Enoxaparin
Winthrop.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Enoxaparin
Winthrop against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT ENOXAPARIN
WINTHROP IS USED FOR
Enoxaparin Winthrop is used in a
number of medical conditions. It is
used to:
•
treat blood clots
•
treat certain types of heart disease
(eg. 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).
Enoxaparin Winthrop is one of a
group of medicines called low
molecular weight heparins (LMWH).
These medicines work by reducing
blood clotting activity.
Your doctor may have prescribed
Enoxaparin Winthrop for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ENOXAPARIN
WINTHROP HAS BEEN PRESCRIBED FOR
YOU.
There is no evidence that Enoxaparin
Winthrop is addictive.
This medicine is only available with
a doctor's prescription.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT USE IT_
DO NOT USE ENOXAPARIN WINTHROP
IF YOU HAVE AN ALLERGY TO
ENOXAPARIN WINTHROP (ENOXAPARIN
SODIUM), HEPARIN OR ITS DERIVATIVES
INCLUDING OTHER LMWHS. SOME
SIGNS AND SYMPTOMS OF AN ALLERGIC
REACTION CAN INCLUDE SWELLING OF THE
FACE, LIPS OR TONGUE, WHEEZING OR
TROUBLED BREATHING, SKIN RASH,
ITCHING HIVES, BLISTERS OR PEELING
SKIN.
DO NOT USE ENOXAPARIN WINTHROP
IF YOU HAVE, OR HAVE EVER HAD ANY
OF THE FOLLOWING MEDICAL
CONDITIONS:
•
major blood disorders
•
certain types of stroke
•
stomach or bowel problems

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION – ENOXAPARIN
WINTHROP AND ENOXAPARIN WINTHROP FORTE (ENOXAPARIN
SODIUM)
1
NAME OF THE MEDICINE
Enoxaparin sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ENOXAPARIN WINTHROP
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)
ENOXAPARIN WINTHROP (WITH AUTOMATIC 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)
ENOXAPARIN WINTHROP 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)
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ENOXAPARIN WINTHROP FORTE (WITH AUTOMATIC 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 be