Obizur



Obizur

Product Specs Obizur
Manufacturer Name Takeda
Indications OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence, is an antihemophilic factor indicated for the on-demand treatment and control of bleeding episodes in adults with acquired hemophilia A.
Contraindications Do not use in patients who have had life-threatening hypersensitivity reactions to OBIZUR or its components, including hamster protein.
Manufacturing Methods Genetically engineered baby hamster kidney (BHK) cell line which secretes rpFVIII into the cell culture medium
Viral Safety Process Chromatography, solvent/detergent treatment, nanofiltration
Route of Administration Intravenous
Product Half-Life Range 2.6 to 28.6 hours
Shelf Life Listed on label
Storage Requirements
  • Refrigerated at 2°C to 8°C (36° to 46°F).
  • Do not freeze.
  • Available Formulations When reconstituted with the diluent, the product contains the following components per mL: 8.8 mg sodium chloride, 0.04 mg Tris-base, 0.73 mg Tris-HCl, 1.47 mg trisodium citrate dehydrate, 0.15 mg calcium chloride dehydrate, 1.9 mg sucrose, and 0.05 mg polysorbate 80


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