Recombinate

Product Specs	Description
Manufacturer Name	Takeda
Indications	RECOMBINATE is recombinant Factor VIII, a clotting factor that is deficient in people with hemophilia A. RECOMBINATE is used to help control bleeds when they occur and prevent future bleeds.
Indications for Adults:
Control and Prevention of Bleeding Episodes	Yes
Perioperative Management	Yes
Routine Prophylaxis to Prevent or Reduce the Frequency of Bleeding Episodes	Yes
Indications for Children:
Control and Prevention of Bleeding Episodes	Yes
Perioperative Management	Yes
Routine Prophylaxis to Prevent or Reduce the Frequency of Bleeding Episodes	Yes
Contraindications Nutrient in Cell Culture	Contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including bovine, mouse or hamster proteins.
Stabilizer in Final Formulation	Albumin (Human), calcium, polyethylene glycol,sodium, histidine, polysorbate 80
Viral Safety Process	Immunoaffinity chromatography
Product Half-Life	14.6 ± 4.9 hours
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg)	123.9 ± 47.7
Storage Requirements/Shelf Life	Can be refrigerated [2° – 8°C (36° – 46°F)] or stored at room temperature, not to exceed 30°C (86°F). Avoid freezing to prevent damage to the diluent vial. Do not use beyond the expiration date printed on the box.
Nominal Vial Size & Diluent Volume	250, 500, 1000, 1500, and 2000 IU/5mL

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