Treatment of venous thromboembolism (VTE) presenting clinically as deep vein thrombosis (DVT), pulmonary embolism (PE) or both: Adults A single dose of Fragmin is administered subcutaneously, once daily according to the following weight ranges.
Monitoring of the anticoagulant effect is not usually necessary. Weight (kg) Dose 46-56 10,000 IU 57-68 12,500 IU 69-82 15,000 IU 83 and over 18,000 IU Abbreviations: IU = International Unit The single daily dose should not exceed 18 000 IU.
Simultaneous anti-coagulation with 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.
Patients with solid tumours:
Extended treatment of symptomatic venous thromboembolism (VTE) and prevention of its recurrence. Month 1 Administer Fragmin 200 IU/kg total body weight subcutaneously (SC) once daily for the first 30 days of treatment. The total daily dose should not exceed 18,000 IU daily.
Body Weight (kg) Dose (IU) <46 7 500 46-56 10 000 57-68 12 500 69-82 15 000 83 and over 18 000* * Maximum dose of 18, 000 IU was used in patient weighing up to 132 kg in the CLOT study. In the case of chemotherapy-induced thrombocytopenia, Fragmin dose should be adopted as follows: - In patients receiving Fragmin who experience platelet counts between 50,000 and 100,000/mm3, the daily dose of Fragmin should be reduced by 2,500 IU until the platelet count recovers to ≥100,000/mm3.
- In patients receiving Fragmin who experience platelet counts <50,000/mm3, Fragmin should be discontinued until the platelet count recovers above 50,000/mm3. Months 2-6 Fragmin should be administered at a dose of approximately 150 IU/kg, subcutaneously, once daily using fixed dose syringes and the table shown below.
Body Weight (kg) Dose (IU) ≤56 7 500 57 to 68 10 000 69 to 82 12 500 83 to 98 15 000 ≥99 18 000 Recommended duration of treatment is 6 months (first month of Fragmin treatment is included). Relevance of continuing treatment beyond this period will be evaluated according to individual risk/benefit ratio, taking into account particularly the progression of cancer.
No data is available with dalteparin beyond 6 months of treatment in the CLOT study. In the case of chemotherapy-induced thrombocytopenia, Fragmin dose should be adopted as follows: - With platelet counts <50,000/mm3, Fragmin dosing should be interrupted until the platelet count recovers above 50,000/mm3 - For platelet counts between 50,000 and 100,000/mm3, Fragmin should be reduced as illustrated in the table below depending on the patient’s weight.
Once the platelet count has recovered to ≥100,000/mm3, Fragmin should be re-instituted at full dose. Body Weight (kg) Scheduled Fragmin Dose (IU) Reduced Fragmin Dose (IU) ≤56 7 500 5 000 57 to 68 10 000 7 500 69 to 82 12 500 10 000 83 to 98 15 000 12 500 ≥99 18 000 15 000 Renal failure: In the case of significant renal failure, defined as a creatinine clearance <30 ml/min, the dose of Fragmin should be adjusted based on anti-Factor Xa activity.
If the anti-Factor Xa level is below or above the desired range, the dose of Fragmin should be increased or reduced respectively, and the anti- Factor Xa measurement should be repeated after 3-4 new doses. This dose adjustment should be repeated until the desired anti-Factor Xa level is achieved.
70), respectively, on week 1 and 4 of dalteparin 200 IU/kg OD. Anti-Factor Xa activity determinations were conducted by the chromogenic method. For patients with an increased risk of bleeding, it is recommended that Fragmin be administered according to the twice daily regimen detailed in the Summary of Product Characteristics for Fragmin 10,000 IU/1ml ampoules or Fragmin Multidose Vial.
Paediatric population Treatment of symptomatic venous thromboembolism (VTE) in paediatric patients 1 month of age and older. A concentration of 2,500 IU/ml is recommended to ensure accuracy of dosing for the youngest age cohort. 6). For children under 3 years of age, a presentation without benzyl alcohol should be used.
Treatment of symptomatic venous thromboembolism in paediatric patients The recommended starting dose according to paediatric age is provided in the table below. 0 ml; if it is below/above this range, a less/more concentrated (respectively) solution for administration should be prepared.
0 ml of the solution as supplied and then add diluent (diluent volume is expressed as a multiple of V); administer the correct volume of the diluted solution. For children >20 kg, the 12,500 IU/ml concentration may also be administered directly, without dilution.
** The 10,000 IU/ml (10 ml vial) and 25,000 IU/ml (4 ml vial) multidose vials contain benzyl alcohol. For children under 3 years of age, a presentation without benzyl alcohol should be used. *** […]