Active Ingredient: Coagulation factor X
Coagulation factor X is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
30 - 50 [iU] per kg of body weight
From 30 To 50 [iU] per kg of body weight once every day
For on-demand control of bleeding in children aged less than 12 years:__ 30 IU/kg Coagadex should be injected when the first sign of bleeding occurs. Repeat at intervals of 24 hours until the bleed stops. Judge each individual bleed on its own severity.
For secondary prophylaxis against re-bleeding or short-term prophylaxis prior to anticipated physical activity or dental appointments: 30 IU/kg Coagadex should be injected and repeated as required.
For routine prophylaxis of bleeding episodes in children aged less than 12 years: 40 IU/kg twice weekly. Due to inter-and intra-patient variability, it is recommended that trough blood levels of Factor X should be monitored at intervals, especially in the first weeks of therapy or after dosage changes. Adjust dosage regimen to clinical response and trough levels of Factor X of at least 5 IU/dL. Some patients may achieve desired FX trough levels on once weekly prophylactic therapy (see section 5.1).
For perioperative management in children aged less than 12 years: Pre-surgery: calculate dose of Coagadex to raise plasma factor X levels to 70-90 IU/dL. The careful control of dose and duration of treatment is especially important in cases of major surgery.
The expected in vivo peak increase in factor X level expressed as IU/dL (or % of normal) can be estimated using the following formulae:
Dose (IU) = body weight (kg) x desired factor X rise (IU/dL or % of normal) x 0.6
OR
Increase in factor X level (IU/dL or % of normal) = [total dose (IU)/body weight (kg)] x 1.7
Post-surgery: dose as necessary to maintain plasma factor X levels at a minimum of 50 IU/dL until the subject is no longer at risk of bleeding due to surgery.
It is recommended that post-infusion plasma factor X levels are measured for each patient before and after surgery, to ensure that haemostatic levels are obtained and maintained.
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