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RAPLIXA
Bleeding disorders
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Drug Name:

RAPLIXA Rx

Generic Name and Formulations:
Human fibrinogen 79mg, human thrombin 699 IU; per 1g; ready-to-use pwd; preservative-free; contains trehalose, calcium chloride.

Company:
Mallinckrodt, Inc.

Therapeutic Use:

Indications for RAPLIXA:

Adjunct to hemostasis for mild-to-moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques is ineffective or impractical. Use in conjunction with absorbable gelatin sponge or RaplixaSpray device.

Adult:

See full labeling. Apply to surface of bleeding tissue only; give directly from vial using absorbable gelatin sponge or RaplixaSpray device (max 2 vials per device). Individualize dose based on size of bleeding area; max total dose 3g per surgery. Max surface area (25cm2 [vial] or 50cm2 [RaplixaSpray]): use 0.5g; (50cm2 [vial] or 100cm2 [RaplixaSpray]): use 1g; (100cm2 [vial] or 200cm2 [RaplixaSpray]): use 2g.

Children:

Not established.

Contraindications:

Intravascular use. Severe or brisk arterial bleeding. Systemic reactions to human blood products.

Warnings/Precautions:

For topical use only. Life-threatening thrombosis possible from intravascular application. Monitor BP, pulse, oxygen saturation, end tidal CO2 for signs/symptoms of embolism. Contains human plasma; monitor for possible infection transmission (eg, viruses, Creutzfeldt-Jakob disease agent). Discontinue immediately if hypersensitivity reactions occur. Pregnancy. Nursing mothers.

Pharmacological Class:

Topical hemostatic.

Adverse Reactions:

Procedural pain, nausea, constipation, pyrexia, hypotension; infection, possible antibody formation.

Generic Availability:

NO

How Supplied:

Single-use vial (0.5g, 1g, 2g)—1

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