FRAGMIN 2.500 IU Solution for injection Ref.[8111] Active ingredients: Dalteparin

Adults

Surgical thromboprophylaxis in patients at moderate risk of thrombosis 2,500 IU is administered subcutaneously 1-2 hours before the surgical procedure and thereafter 2,500 IU subcutaneously each morning until the patient is mobilised, in general 5-7 days or longer.

Surgical thromboprophylaxis in patients at high risk of thrombosis 2,500 IU is administered subcutaneously 1-2 hours before the surgical procedure and 2,500 IU subcutaneously 8-12 hours later. On the following days, 5,000 IU subcutaneously each morning.

As an alternative, 5,000 IU is administered subcutaneously the evening before the surgical procedure and 5,000 IU subcutaneously the following evenings.

Treatment is continued until the patient is mobilised, in general 5-7 days or longer.

Prolonged thromboprophylaxis in hip replacement surgery: 5,000IU is given subcutaneously the evening before the operation and 5,000IU subcutaneously the following evenings. Treatment is continued for five post-operative weeks.

If pre-operative administration of Fragmin is not considered appropriate because the patient is at high risk of haemorrhage during the procedure, post-operative Fragmin may be administered (see Section 5.1).

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.

Method of administration

By subcutaneous injection, preferably into the abdominal subcutaneous tissue anterolaterally or posterolaterally, or into the lateral part of the thigh. Patients should be supine and the total length of the needle should be introduced vertically, not at an angle, into the thick part of a skin fold, produced by squeezing the skin between the thumb and forefinger; the skin fold should be held throughout the injection.

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 25°C.

Fragmin 2,500 IU/0.2ml solution for injection is supplied in 0.5ml glass Ph. Eur Type I single dose pre-filled syringes with a latex-free needle shield, chlorobutyl rubber, polypropylene rod and a needle-trap (safety) feature. Each pack contains 10 syringes.

The Needle-Trap consists of a plastic needle “catcher” which is firmly attached to the syringe label. Together, these two components comprise the Needle-Trap (safety) feature. The Needle-Trap is designed to specifically help prevent accidental needle sticks following the proper administration of injectable medications.

The Needle-Trap requires specific actions by the user to “activate” the Needle-Trap, which will render the needle harmless after the injection is administered:

• The user grasps the tip of the plastic needle catcher and bends it away from needle shield.
• The needle shield is removed from the syringe.
• The injection is administered normally.
• The needle is removed from the patient. The Needle-Trap is activated by placing the plastic catcher against a hard, stable surface and with one hand, pivoting the syringe barrel upward against the needle forcing the needle into the catcher where it locks in place (an audible 'click" is heard when the needle is locked in the catcher). The needle is bent until the syringe exceeds a 45 degree angle with the flat surface to render it permanently unusable.
• The syringe is properly disposed of normally.