FRAGMIN 100.000 IU Solution for injection Ref.[10849] Active ingredients: Dalteparin

Recommended dosage for adults

Treatment of venous thromboembolism (VTE).

Fragmin can be administered subcutaneously either as a single daily injection or as twice daily injections.

(a) Once daily administration

200 IU/kg body weight is administered s.c once daily. Monitoring of the anticoagulant effect is not necessary. The single daily dose should not exceed 18,000 IU.

(b) Twice daily administration

A dose of 100 IU/kg body weight administered s.c twice daily can be used for patients with increased risk of bleeding. Monitoring of the treatment is generally not necessary but can be performed with a functional anti-Factor Xa assay. Maximum plasma levels are obtained 3-4 hours after s.c injection, when samples should be taken. Recommended plasma levels are between 0.5-1.0 IU (anti-Factor Xa)/ml.

Simultaneous anticoagulation with oral vitamin K antagonists can be started immediately. Treatment with Fragmin is continued until the prothrombin complex levels (factor II, VII, IX and X) have decreased to a therapeutic level. At least five days of combined treatment is normally required.

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.

2 Years. Once opened, the solution should be used within 14 days.

Store below 30°C.

Multidose vial (Ph Eur Type 1) with bromobutyl rubber stopper, secured with aluminium overseal with flip off cap, containing dalteparin sodium 100,000 IU (anti-Factor Xa) in 4 ml.

As with other multidose preparations, care should be taken to avoid any risk of cross-contamination during use.

Any unused medicinal product should be disposed of in accordance with local requirements.