RAPLIXA fibrinogen human and thrombin powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K)

Available from:

ProFibrix BV

INN (International Name):

FIBRINOGEN HUMAN

Composition:

FIBRINOGEN HUMAN 79 mg in 1 g

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

RAPLIXA- FIBRINOGEN HUMAN AND THROMBIN HUMAN POWDER
PROFIBRIX BV
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RAPLIXA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR RAPLIXA.
RAPLIXA (FIBRIN SEALANT (HUMAN))
POWDER FOR TOPICAL USE ONLY
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
RAPLIXA is a fibrin sealant indicated as an adjunct to hemostasis for
mild to moderate bleeding in adults undergoing
surgery when control of bleeding by standard surgical techniques (such
as suture, ligature, and cautery) is ineffective or
impractical.
RAPLIXA is used in conjunction with an absorbable gelatin sponge (USP)
and is applied directly or using the
RaplixaSpray™ device. (1)
DOSAGE AND ADMINISTRATION
For topical use only.
Do not reconstitute. Use within one hour after opening.
The required dose of RAPLIXA depends on the size of the bleeding area.
The maximum total dose of RAPLIXA per
surgery is 3 grams. (2)
Applying to the surface of bleeding tissue only, administer RAPLIXA
directly from the vial or using the RaplixaSpray
delivery device. RAPLIXA may be used at multiple bleeding sites in the
same patient. Use no more than two vials of
RAPLIXA with the RaplixaSpray device. To administer a third vial, open
a new device. (2)
DOSAGE FORMS AND STRENGTHS
RAPLIXA is available as dry, ready-to-use powder containing nominally
79 mg human fibrinogen and 699 international
units human thrombin per gram of powder. RAPLIXA is supplied in single
use glass vials in three presentations: 0.5 gram,
1 gram, and 2 grams per vial. (3)
CONTRAINDICATIONS
Do not use:
Intravascularly.
For the treatment of severe or brisk arterial bleeding.
In patients known to have anaphylactic or severe systemic reactions to
human blood products. (4)
WARNINGS AND PRECAUTIONS
Thromboembolic events may result from intravascular application of
RAPLIXA. (5.1)
Air or gas embolism can occur using air- or gas-pressurized sprayers
to administer fibrin sealants. Operate the device
according