Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
FIBRINOGEN HUMAN (UNII: N94833051K) (FIBRINOGEN HUMAN - UNII:N94833051K)
ProFibrix BV
FIBRINOGEN HUMAN
FIBRINOGEN HUMAN 79 mg in 1 g
PRESCRIPTION DRUG
Biologic Licensing Application
RAPLIXA- FIBRINOGEN HUMAN AND THROMBIN HUMAN POWDER PROFIBRIX BV ---------- 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 Lugege kogu dokumenti