Factor VIIa (recombinant)

maxDose is blank because §4.2 states no absolute ceiling for any NovoSeven regimen — no 'maximum' figure appears anywhere in the bundle; duration and interval are driven by bleed severity. Other §4.2 regimens for this page's stated settings, all verbatim. Mild to moderate bleeds including home therapy — two options: '1) Two to three injections of 90 µg per kg body weight administered at three-hour intervals. If further treatment is required, one additional dose of 90 µg per kg body weight can be administered. 2) One single injection of 270 µg per kg body weight.' with 'The duration of home therapy should not exceed 24 hours' and 'There is no clinical experience with administration of a single dose of 270 µg per kg body weight in elderly patients.' Serious bleeds: 'An initial dose of 90 µg per kg body weight is recommended and could be administered on the way to the hospital ... Dosing frequency should initially be every second hour until clinical improvement is observed.' Invasive procedure or surgery: 'An initial dose of 90 µg per kg body weight should be given immediately before the intervention. The dose should be repeated after 2 hours and then at 2 – 3 hour intervals for the first 24 – 48 hours ... In major surgery, the dose should be continued at 2 – 4 hour intervals for 6 – 7 days.' Glanzmann's thrombasthenia: '90 µg (range 80 – 120 µg) per kg body weight at intervals of two hours (1.5 – 2.5 hours). At least three doses should be administered to secure effective haemostasis. The recommended route of administration is bolus injection as lack of efficacy may appear in connection with continuous infusion. For those patients who are not refractory, platelets is the first line treatment.' Congenital factor VII deficiency: '15 – 30 µg per kg body weight every 4 – 6 hours until haemostasis is achieved.' Severe postpartum haemorrhage: '60 – 90 µg per kg body weight administered by intravenous bolus injection ... in case of insufficient haemostatic response, a second dose can be administered after 30 minutes.' Supportive measures, verbatim: 'Maintenance of adequate fibrinogen concentration and platelet count is recommended in order to optimise the benefit of NovoSeven treatment.' Specialist supervision is required, verbatim: 'Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleeding disorders.'

The SPC applies the adult per-kilogram figure to children, so the same 90 micrograms/kg per-dose figure drives the calculator. §4.2, Paediatric population, verbatim: 'Current clinical experience does not warrant a general differentiation in dosing between children and adults, although children have faster clearance than adults. Therefore, higher doses of rFVIIa may be needed in paediatric patients to achieve similar plasma concentrations as in adult patients.' ⚠️ Read that second sentence before relying on the calculator: it warns that a child may need MORE than the calculated 90 micrograms/kg, and the SPC gives no upward figure — dose to clinical haemostasis under haemophilia-centre direction. maxDose is blank because no ceiling is stated. concentration is null because no reconstituted milligram-per-millilitre strength appears in this bundle (§4.2 refers reconstitution out to §6.6, which was not fetched) — read the strength off the reconstituted vial rather than calculating a volume from this page. §4.4 lists neonates among the groups in whom 'the potential benefit of treatment with NovoSeven should be weighed against the risk' of thromboembolic complications. Verify against a children's formulary and the treating haemophilia centre.