PRODUCTS to TREAT RARE FACTOR DEFICIENCIES Riastap
P RODUCTS TO TREAT RARE FACTOR DEFICIENCIES
Viral Product Plasma source Fractionation Vial size Storage Availability Comments inactivation
Multiple virus In Used to treat inactivation and 1 g of human refrigerator congenital fibrinogen USA: volunteer, RiaSTAP™ Multiple removal steps, fibrinogen, or at room Licensed by Health deficiency which remunerated Manufactured by precipitation including reconstituted with temperature Canada, distributed in comprises congenital plasmapheresis CSL Behring absorption steps pasteurization 50 mL of sterile between all provinces afibrinogenemia and donors @ 60°C, 20 water 2°C and hypofibrinogenemia, hours 25°C albumin added Contains factors II, Vapour heat @ USA: volunteer, Available through VII, IX and X, used to Prothromplex‐T 60°C for 10 hr at remunerated Ion exchange Special Access treat prothrombin Manufactured by 190 mbar, then 600 IUs 2‐8°C plasmapheresis adsorption Programme, distributed (factor II) deficiency Baxter 80°C for 1 hr @ donors in all provinces and factor X 375 mbar deficiency
Vapour heat @ USA: volunteer, Available through Bebulin VH 60°C for 10 hr at remunerated Ion exchange Special Access Factor IX complex, Manufactured by 190 mbar, then 600 IUs 2‐8°C plasmapheresis adsorption Programme, distributed heparin added Baxter 80°C for 1 hr @ donors in all provinces 375 mbar
Vapour heat @ Factor VII USA: volunteer, Available through Aluminium 60°C for 10 hr at concentrate remunerated Special Access Used to treat hydroxide 190 mbar, then 600 IUs 2‐8°C Manufactured by plasmapheresis Programme, distributed factor VII deficiency adsorption 80°C for 1 hr @ Baxter donors in all provinces 375 mbar
Factor XI Sometimes used to USA: volunteer, Available through Affinity heparin treat factor XI concentrate remunerated Dry heat @ Special Access sepharose 1,000 IUs 2‐8°C deficiency, heparin Manufactured by plasmapheresis 80°C, 72 hr Programme, distributed chromatography and anti‐thrombin III Bio Products Limited donors in all provinces (BPL) added USA: volunteer, Available through Fibrogammin P Used to treat remunerated Multiple Pasteurization Special Access Manufactured by 250, 1,250 IUs 2‐8°C factor XIII deficiency, plasmapheresis precipitation @ 60°C, 10 hr Programme, distributed CSL Behring albumin added donors in all provinces 1 Tretten (catridecacog) is indicated for routine prophylaxis for bleeding in Recombinant Purification patients with protein Tretten® through a series Licensed by Health congenital factor XIII manufactured Manufactured by Not applicable of 2,500 IUs 2‐8°C Canada, distributed in A‐subunit deficiency. without the use Novo Nordisk chromatography all provinces Should not be used of human or steps for prophylactic animal proteins treatment of bleeding in patients with congenital factor XIII B‐subunit deficiency Production of NiaStase RT® via recombinant NiaStase is called DNA technology NovoSeven® 1.0 mg (50 Licensed to treat eliminates the elsewhere in world. Recombinant KIU/vial) bleeding and in surgery NiaStase RT® risks of The European factor VIIa 2.0 mg (100 for patients with Manufactured by Not applicable transmission of 2‐30°C Medicines Agency has (eptacog alfa ‐ KIU/vial) hemophilia A or B and Novo Nordisk human blood‐ approved the use of activated) 5.0 mg (250 inhibitors, distributed in borne NovoSeven for KIU/vial) all provinces pathogens such congenital factor VII as HIV, hepatitis deficiency. viruses and parvovirus.
Last revised – January 14, 2014
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