FRAGMIN 10.000 IU Solution for injection Ref.[10846] Active ingredients: Dalteparin

Recommended dosage for adults

• Prevention of clotting during haemodialysis and haemofiltration*

In chronic renal insufficiency for patients with no known additional bleeding risk, the dosage is:

(a) Long-term haemodialysis or haemofiltration – duration of haemodialysis/haemofiltration more than 4 hours;

An iv bolus injection of Fragmin 30-40 IU (anti-Factor Xa)/kg bodyweight, followed by an infusion of 10-15 IU (anti-Factor Xa)/kg bodyweight/hour.

(b) Short-term haemodialysis or haemofiltration – duration of haemodialysis/haemofiltration less than 4 hours:

Either as above, or, a single iv bolus injection of Fragmin 5000 IU (anti-Factor Xa).

Both for long and short-term haemodialysis and haemofiltration, the plasma anti-Factor Xa levels should be within the range 0.5-1.0 IU (anti-Factor Xa)/ml.

In acute renal failure, or chronic renal failure in patients with a high risk of bleeding, the dosage is:

An iv bolus injection of Fragmin 5-10 IU (anti-Factor Xa)/kg bodyweight, followed by an infusion of 4-5 IU (anti-Factor Xa)/kg bodyweight/hour.

The plasma anti-Factor Xa levels should be within the range 0.2-0.4 IU (anti-Factor Xa)/ml.

When considered necessary, it is recommended that the antithrombotic effect of Fragmin be monitored by analysing anti-Factor Xa activity using a suitable chromogenic substrate assay. This is because Fragmin has only a moderate prolonging effect on clotting time assays such as APTT or thrombin time.

Paediatric population

The safety and efficacy of dalteparin sodium in children has not been established. Currently available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.

Monitoring Anti-Xa levels in children

Measurement of peak anti-Xa levels at about 4 hours post-dose should be considered for certain special populations receiving Fragmin, such as children. For therapeutic treatment with doses administered once daily, peak anti-Xa levels should generally be maintained between 0.5 and 1.0 IU/mL measured at 4 hours post-dose. In the case of low and changing physiologic renal function such as in neonates, close monitoring of anti-Xa levels is warranted. For prophylaxis treatment the anti-Xa levels should generally be maintained between 0.2-0.4 IU/mL.

As with all antithrombotic agents, there is a risk of systemic bleeding with Fragmin administration. Care should be taken with Fragmin use in high dose treatment of newly operated patients. After treatment is initiated patients should be carefully monitored for bleeding complications. This may be done by regular physical examination of the patients, close observation of the surgical drain and periodic measurements of hemoglobin, and anti-Xa determinations.

Elderly

Fragmin has been used safely in elderly patients without the need for dosage adjustment.

The anticoagulant effect (i.e. prolongation of the APTT) induced by Fragmin is inhibited by protamine. Since protamine itself has an inhibiting effect on primary haemostasis it should be used only in an emergency.

The prolongation of the clotting time induced by Fragmin may be fully neutralised by protamine, but the anti-Factor Xa activity is only neutralised to about 25-50%. 1 mg of protamine inhibits the effect of 100 IU (anti-Factor Xa) of Fragmin.

3 years.

Store below 30°C.

Clear glass ampoules (Ph Eur Type 1) containing dalteparin sodium, 10,000 IU (anti-factor Xa) in 4 ml.

Fragmin solution for injection is compatible with isotonic sodium chloride (9 mg/ml) or isotonic glucose (50 mg/ml) infusion solutions in glass bottles and plastic containers for up to 24 hours. Compatibility between Fragmin and other products has not been studied.