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Recombinate
| Manufacturer:
Baxter Corporation |
| Generic Name:
Anti-Hemophilic
Factor VIII (Recombinant)-rAHF |
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Indications:
- The use of Recombinate [Antihemophilic Factor (Recombinant0] is indicated in hemophilia A(classical hemophilia)for the prevention and control of hemorrhagic episodes.
- Recombinate is also indicated in the perioperative management of patients with hemophilia A (classical hemophilia).
- Recombinate can be of therapeutic value in patients with acquired Factor VIII inhibitors not exceeding 10 Bethesda Units per mL. In clinical studies with Recombinate, patients with inhibitors who were entered into the previously treated patient trial and those previously treated patient trial and those previously untreated children who have developed inhibitor activity on study, showed clinical hemostatic response when the titer of inhibitor was less than 10 Bethesda Units per mL. However, in such uses, the dosages of Recombinate should be controlled by frequent
laboratory determinations of circulating Factor VIII levels as well as the clinical status of the patient.
- Recombinate is not indicated in von Willebrand's disease.
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| How Supplied: Factor products are
supplied in vials sizes of varying International Units (iu). Vial
sizes (iu sizes) may change with each new lot of product
manufactured. Vial sizes may range from approximately 200 - 1500 iu
per vial. |
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| Product |
Size |
NDC Numbers |
PI |
MSDS |
| Recombinate |
220-400 unit vial |
00944-2841-10 |
PI |
MSDS |
| Recombinate |
401-800 unit vial |
00944-2842-10 |
PI |
MSDS |
| Recombinate |
801-1240 unit vial |
00944-2843-10 |
PI |
MSDS |
| Recombinate |
1241-1800 unit vial |
00944-2844-10 |
PI |
MSDS |
| Recombinate |
1801-2400 unit vial |
00944-2845-10 |
PI |
MSDS |
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| Clinical Data:
For any questions or for
further information related to
Recombinant, Anti-Hemophilic
Factor VIII (Recombinant)-rAHF, clinical pharmacology, additional indications and
usages, contraindications,
warnings, precautions, adverse
reactions, dosage,
administration and/or storage
of this product, please
contact
BDI Pharma or call 1-800-948-9834. |
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