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factor VIII concentrate
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MODEL LIST INFORMATION
SECTION FORMULATION DISEASE/INDICATION RATIONALE FOR INCLUSION
11.02.00.00 Plasma fractions for specific use Dosage form and strength

Dried.



ATC Code
B02BD02

Type of List
Complementary List

Control of haemorrhage in haemophilia A. All plasma fractions should comply with the WHO Requirements for the Collection, Processing and Quality Control of Blood, Blood Components and Plasma Derivatives (Revised 1992). WHO Expert Committee on Biological Standardization Forty-third report, WHO Technical Report Series, No. 840, 1994, Annex 2.

Added to list 1979.

Square box to accommodate cryoprecipitate.

Specific expertise, diagnostic precision, individualization of dosage or special equipment required for proper use.

The use of alternative treatment, in the form of cryoprecipitate or fresh frozen plasma is less effective and less safe.

 

MODEL FORMULARY INFORMATION
GENERAL INFORMATION

Plasma fractions should comply with the WHO Requirements for the Collection, Processing and Quality Control of Blood, Blood Components and Plasma Derivatives (Revised 1992). WHO Technical Report Series, No. 840, 1994, Annex 2

 

Factor VIII concentrate is a complementary preparation and a representative coagulation factor preparation. Various preparations can serve as alternatives

 

Uses: control of haemorrhage in haemophilia A

 

Precautions: intravascular haemolysis after large or frequently repeated doses in patients with blood groups A, B, or AB (less likely with high potency, highly purified concentrates)

 

Dose: Haemophilia A, by slow intravenous infusion, ADULT and CHILD according to patient’s needs

 

Adverse effects: allergic reactions including chills, fever



MEDICINE REFERENCES
WHO Technical Report Series 796: The use of essential drugs.
http://whqlibdoc.who.int/trs/WHO_TRS_796.pdf
14th Expert Committee on the Selection and Use of Essential Medicines 7-11 March 2005, Medicines for possible deletion.
http://mednet3.who.int/EML/expcom/expcom14/expcom05del.htm
Delivery of Treatment for Haemophilia.
http://whqlibdoc.who.int/hq/2002/WHO_WFH_ISTH_WG_02.6.pdf
WHO recommendations for the production, control and regulation of human plasma for fractionation.
http://www.who.int/biologicals/publications/ECBS%202005%20Annex%204%20Human%20Plasma%20Fractionation.pdf
Cochrane review: Recombinant Factor VIIa concentrate versus plasma derived concentrates for the treatment of acute bleeding episodes in people with Haemophilia A and inhibitors.
http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD004449/frame.html