FRAXIPARINE INJECTION 0.8ML

Country: Malaysia

Language: English

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

Active ingredient:

HEPARIN GLYCOSAMINOGLYCAN/NADROPARIN CALCIUM

Available from:

Aspen Medical Products Malaysia Sdn Bhd

INN (International Name):

HEPARIN GLYCOSAMINOGLYCAN/NADROPARIN CALCIUM

Units in package:

2Units Units; 10Units Units

Manufactured by:

Aspen Notre Dame De Bondeville

Patient Information leaflet

Not Applicable

Summary of Product characteristics

1
FRAXIPARINE
Nadroparin Calcium
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
-
0.2 ml of solution equivalent to 1,900 anti-Xa IU
-
0.3 ml of solution equivalent to 2,850 anti-Xa IU
-
0.4 ml of solution equivalent to 3,800 anti-Xa IU
Graduated pre-filled syringes:
-
0.6 ml of solution equivalent to 5,700 anti-Xa IU
-
0.8 ml of solution equivalent to 7,600 anti-Xa IU
-
1 ml of solution equivalent to 9,500 anti-Xa IU
PHARMACEUTICAL FORM
Clear to slightly opalescent, colourless or slightly coloured solution
for injection.
CLINICAL INFORMATION
Therapeutic Indications

Prophylaxis of thromboembolic disorders, such as:
•
those associated with general or orthopaedic surgery
•
those in high risk medical patients (respiratory failure and/or
respiratory infection
and/or cardiac failure), immobilised due to acute illness or
hospitalised in an intensive
care unit

Treatment of thromboembolic disorders

Treatment of unstable angina and non-Q wave myocardial infarction

Prevention of clotting during haemodialysis
Posology and Method of Administration
General
Particular attention should be paid to the specific dosing
instructions for each proprietary Low
Molecular Weight Heparin, as different units of measurement (units or
mg) are used to express
doses. Nadroparin should therefore not be used interchangeably with
other low molecular
weight heparins during ongoing treatment. In addition, care should be
taken to use the correct
formulation of nadroparin, either single or double strength, as this
will affect the dosing
regimen.
Graduated syringes are intended for use when dose adjustment for body
weight is necessary.
2
Platelet count must be monitored throughout nadroparin treatment (see
Special warnings and
precautions for use).
Specific
recommendations
regarding
the
timing
of
nadroparin
dosing
surrounding
spinal/epidural anaesthesia or spinal lumbar puncture should be
followed (see Special
warnings and precautions for use).
Posology
Adults
PROPHYLAXIS OF THROMBOEMBOLIC DISORDERS

General Surge