P RODUCTS TO TREAT RARE FACTOR DEFICIENCIES
Product Plasma source Fractionation Viral inactivation Vial size Storage Availability
USA: volunteer, Vapour heat @ 60°C for 10 hr at Available through Special Bebulin VH remunerated Ion exchange 190 mbar, then 80°C for 1 hr @ 600 IUs 2‐8°C Access Programme. Manufactured by plasmapheresis adsorption 375 mbar Shire donors distributed in all provinces. Comments Factor IX complex containing factors II, VII, IX and X, heparin added.
Product Plasma source Fractionation Viral inactivation Vial size Storage Availability
Purification steps: 1) Precipitation/adsorption 250 IUs USA: volunteer, (4 mL of diluent) 2) Ion exchange chromatography Corifact remunerated Multiple Licensed by Health Canada. 1,250 IUs 2‐8°C Manufactured by plasmapheresis precipitation 3) Heat‐treatment (+60°C for 10 (20 mL of diluent) Distributed in all provinces. CSL Behring donors hours in an aqueous solution) 4) Virus filtration over two 20 nm Mix2Vial filters in series Comments Indicated for routine prophylaxis and peri‐operative management of surgical bleeding in patients with congenital factor XIII deficiency.
Product Plasma source Fractionation Viral inactivation Vial size Storage Availability
Factor VII USA: volunteer, Aluminium Vapour heat @ 60°C for 10 hr at Available through Special remunerated concentrate hydroxide 190 mbar, then 80°C for 1 hr @ 600 IUs 2‐8°C Access Programme. Manufactured by plasmapheresis adsorption 375 mbar Distributed in all provinces. Shire donors Comments Used to treat factor VII deficiency.
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Product Plasma source Fractionation Viral inactivation Vial size Storage Availability
Factor XI USA: volunteer, Affinity heparin Available through Special concentrate remunerated sepharose Dry heat @ 80°C, 72 hr 1,000 IUs 2‐8°C Access Programme. Manufactured by plasmapheresis chromatography Bio Products donors Distributed in all provinces. Limited (BPL) Comments
Sometimes used to treat factor XI deficiency, heparin and anti‐thrombin III added.
Product Plasma source Fractionation Viral inactivation Vial size Storage Availability
1.0 mg Production of NiaStase RT® via (50 KIU/vial) Licensed to treat bleeding Recombinant recombinant DNA technology and in surgery for patients NiaStase RT® factor VIIa eliminates the risks of 2.0 mg Manufactured by Not applicable 2‐30°C with hemophilia A or B and (eptacog alfa ‐ transmission of human blood‐ (100 KIU/vial) inhibitors. Novo Nordisk activated) borne pathogens such as HIV, 5.0 mg hepatitis viruses and parvovirus. Distributed in all provinces. (250 KIU/vial) Comments NiaStase is called NovoSeven® elsewhere in world. The European Medicines Agency has approved the use of NovoSeven for congenital factor VII deficiency.
Product Plasma source Fractionation Viral inactivation Vial size Storage Availability
USA: volunteer, Vapour heat @ 60°C for 10 hr at Available through Special Prothromplex‐T remunerated Ion exchange 190 mbar, then 80°C for 1 hr @ 600 IUs 2‐8°C Access Programme. Manufactured by plasmapheresis adsorption 375 mbar Shire donors Distributed in all provinces. Comments Contains factors II, VII, IX and X, used to treat prothrombin (factor II) deficiency and factor X deficiency.
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Product Plasma source Fractionation Viral inactivation Vial size Storage Availability
1 g of human In refrigerator USA: volunteer, Multiple Multiple virus inactivation and fibrinogen, or at room RiaSTAP™ remunerated precipitation removal steps, including Licensed by Health Canada. reconstituted with temperature Manufactured by plasmapheresis absorption pasteurization @ 60°C 50 mL of sterile between 2°C Distributed in all provinces. CSL Behring donors steps 20 hours water and 25°C Comments Used to treat congenital fibrinogen deficiency which comprises congenital afibrinogenemia and hypofibrinogenemia, albumin added.
Product Plasma source Fractionation Viral inactivation Vial size Storage Availability
Recombinant protein Tretten® manufactured Purification through a series of Licensed by Health Canada. Manufactured by Not applicable 2,500 IUs 2‐8°C without the use chromatography steps Distributed in all provinces. Novo Nordisk of human or animal proteins Comments Tretten (catridecacog) is indicated for routine prophylaxis for bleeding in patients with congenital factor XIII A‐subunit deficiency. Should not be used for prophylactic treatment of bleeding in patients with congenital factor XIII B‐subunit deficiency.
Last revised – January 10, 2017
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