Neonatal Intensive Care Drug Manual




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Recombinant Factor VIIa


Revision Date : 27/10/2020

Approved: TCo, KOH




Indication :


Ongoing microvascular bleeding and coagulopathy from any cause refractory to other corrective measures. Requires active participation of both a Consultant Neonatologist and the On-Call Haematologist in management (via the Paediatric Massive Transfusion Protocol). Supplies should come from transfusion service.

Dose :

90 micrograms/kg.

Interval :

Usually a single dose, but may be repeated 2 hourly if bleeding persists.

Route :

I.V. bolus injection over 2-5 minutes. DO NOT filter

Total Daily Dose :

Guided by Haematologist, repeated dosing may be reasonable if ongoing bleeding and treatment futility not yet reached

Comments :

Complications to rFVIIa are rare. Thrombosis is uncommon. Hypersensitvity may occur, rash, fever, nausea and increased LFT’s have been reported.

rFVIIa should only be considered when there is ongoing bleeding (failure to obtain haemostasis), and where:



  • Adequate blood component replacement has occurred (and Platelets >50, Fibrinogen >2g/L have been achieved); AND

  • All appropriate surgical and embolisation procedures have been attempted; AND

  • pH>7.2, temperature >34°C, actively correct acidosis and hypothermia prior to administration; AND

  • Patient continues to have a treatable condition (further treatment is not considered futile)

Supplied as :

Novoseven or Eptacog alfa 1mg vial (powder) plus prefilled solvent syringe (1mg = 50,000IU)

Dilution :

Reconstitute 1mg vial with provided prefilled solvent syringe; final concentration of 1mg/ml. Swirl gently to dissolve and mix. Draw up 0.09mL/kg for administration to patient.

The remainder of the solution may be used within 24 hours if repeat doses are required.



Stability :

24 hours after reconstitution

Storage :

Store in refrigerator. Protect from light. Do not freeze. Do not use after expiry date.

Incompatibility :

Do not mix with infusion solutions, bolus injection only as close to patient as feasible

Serum Levels :

Not applicable

References:

Australian Product Information NovoSeven RT (eptacog alfa (activated)(bhk)) powder and solvent for solution for injection, Novo Nordisk 2018 https://www.novonordisk.com.au/content/dam/nncorp/au/en/pdfs/NovoSeven%20RT%20pi8.pdf




Original version Date: 9/1/2014

Author: AK, JD

Current Version number: 2

Current Version Date: 27/10/2020

Risk Rating: Medium

Due for Review: 27/10/2025

Approval by: DTC

Approval Date: TBA


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Neonatal Intensive Care Drug Manual

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