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RECOMBINATE
Bleeding disorders
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Drug Name:

RECOMBINATE Rx

Generic Name and Formulations:
Antihemophilic Factor VIII (recombinant) 250 IU, 500 IU, 1000 IU; per bottle; lyophilized pwd for IV infusion after reconstitution; contains albumin; preservative-free.

Company:
Baxter

Therapeutic Use:

Indications for RECOMBINATE:

Prevention and control of hemorrhagic episodes and perioperative management in Hemophilia A.

Adults and Children:

Dosage Required (IU) = Body Weight (kg) × Desired % Factor VIII Increase × 0.5. Infuse at rate of up to 10mL/min. Monitor pulse rate; if increased significantly, reduce infusion rate or hold. Hemorrhage: Mild: obtain 20–40% FVIII increase; give every 12–24hrs for 1–3 days until resolved. Moderate: obtain 30–60% FVIII increase; give every 12–24hrs for 3 days or until pain or disability resolved. Life-threatening: obtain 60–100% FVIII increase; give every 8–24hrs until resolved. Surgery: Minor: obtain 60–80% FVIII increase; give single infusion plus oral antifibrinolytic therapy within 1 hour; Major: pre- and post-op: obtain 80–100% FVIII increase; repeat every 8–24hrs based on healing.

Contraindications:

Mouse, hamster, or bovine protein sensitivity.

Warnings/Precautions:

Not for von Willebrand's disease. Confirm Factor VIII deficiency prior to treatment. Monitor for development of Factor VIII inhibitors. Latex allergy. Pregnancy (Cat.C).

Pharmacological Class:

Clotting factor.

Adverse Reactions:

Allergic reactions, nausea, fever, chills, urticaria, antibody formation.

How Supplied:

Single-dose bottle—1 (w. diluent)

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