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Fraxiparine

Fraxiparine Dosage/Direction for Use

nadroparin

Manufacturer:

Aspen Pharmacare Asia

Distributor:

DCH Auriga - Healthcare
/
Four Star
Full Prescribing Info
Dosage/Direction for Use
Particular attention should be paid to the specific dosing instructions for each proprietary Low Molecular Weight Heparin, as different unit systems (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.
Nadroparin is not intended for IM administration.
Platelet count must be monitored throughout nadroparin treatment (see Precautions).
Specific recommendations regarding the timing of nadroparin dosing surrounding spinal/epidural anaesthesia or spinal lumbar puncture should be followed (see Precautions).
In the prophylaxis or curative treatment, FRAXIPARINE should be administered by the subcutaneous route. In the prevention of clotting during haemodialysis, FRAXIPARINE should be administered into the arterial line at the start of each session.
Subcutaneous injection technique: The usual site for subcutaneous injection is on the right or left side of the abdominal wall, but the thigh may be used as an alternative. To avoid loss of the solution when using pre-filled syringes, the air bubble should not be expelled from the syringe before the injection. The needle should be inserted perpendicularly into a pinched-up fold of skin which should be held gently but firmly until injection has been completed. The injection site should not be rubbed.
Prophylaxis of thromboembolic disorders: General surgery: FRAXIPARINE should be administered as a single daily dose of 0.3 ml for a usual duration of 7 days at least; in all cases prophylaxis should be continued throughout the risk period and at least until the patient is ambulatory. In general surgery the first dose should be given 2 to 4 hours pre-operatively.
Orthopaedic surgery: Initial doses should be given 12 hours before surgery and 12 hours after the end of surgery. These and subsequent once daily doses should be adjusted to body weight based on the table as follows. Treatment should continue for at least 10 days; in all cases, prophylaxis should be continued throughout the risk period and at least until the patient is ambulatory. (See Table 1.)

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Treatment of thromboembolic disorders: Oral anticoagulant therapy is initiated as soon as possible unless there is a contraindication. Treatment with FRAXIPARINE should not be stopped before International Normalised Ratio (INR) target is reached.
FRAXIPARINE should be given subcutaneously twice daily (every 12 hours) for a usual duration of 10 days with the dose adjusted to body weight shown as follows: See Table 2.

Click on icon to see table/diagram/image

Treatment of unstable angina and non-Q wave myocardial infarction: Nadroparin should be administered in 2 daily subcutaneous injection (every 12 hours) of 86 IU anti-Xa/kg each, in combination with aspirin of which the recommended dose is 75-325mg orally, after a loading dose of 160-325mg.
The initial dose of FRAXIPARINE should be given as an IV bolus followed by a SC injection of 86 IU anti-Xa/kg. The usual treatment duration is around 6 days up to clinical stabilisation, with a dose adjusted to body weight shown as follows: See Table 3.

Click on icon to see table/diagram/image

If a thrombolytic treatment is necessary, as there are no clinical data available concerning the concomitant administration of nadroparin and thrombolytic drug, it is recommended to withdraw the treatment with FRAXIPARINE and to follow the patient as usual.
Prevention of clotting during haemodialysis: Optimisation of dosage is required for each individual patient and taking into account the technical conditions of the dialysis. FRAXIPARINE is usually given as a single dose into the arterial line at the start of each session. For patients without increased risk of haemorrhage the following initial doses are suggested according to body weight: See Table 4.

Click on icon to see table/diagram/image

In patients at risk of haemorrhage, dialysis sessions could be done using halved doses.
An additional smaller dose may be given during dialysis for sessions lasting longer than 4 hours. The dose in subsequent dialysis sessions should be adjusted as necessary according to initially observed effect.
Patients should be carefully monitored throughout each dialysis session for signs of bleeding or clotting in the dialysis circuit.
Children and Adolescents: Nadroparin is not recommended in children and adolescents as there are insufficient safety and efficacy data to establish dosage in patients aged less than 18 years.
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