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Rx Item-RAPLIXA (FIBRIN SEALANT (HUMAN)) VL 1 GM

RX585834Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Rx Item-RAPLIXA (FIBRIN SEALANT (HUMAN)) VL 1 GM

$630.00$600.00

RX585834 -RAPLIXA (FIBRIN SEALANT (HUMAN)) VL 1 GM
NDC No. 62238-0008-05 62238-008-05 6223800805 62238000805 UPC/GTIN No.3-62238-00805-1 362238008051 362238-008051 MPN No.000805 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item. for:

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For: Hemostasis

Raplixa (fibrin sealant [human]) is a spray-dried fibrin sealant used to help control bleeding during surgery. HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 onlyInitial U.S. Approval: 2015 __________________INDICATIONS AND USAGE _________________Raplixa is a fibrin sealant indicated as an adjunct to hemostasis formild 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 to the manufacturer's instructions.(5.2) �Raplixa may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agents, despite manufacturing steps designed to reduce the risk of viral transmission. (5.3) �Allergic type hypersensitivity reactions may occur.If allergic type hypersensitivity symptoms occur, discontinue administration immediately. (5.4) _______________ ADVERSE REACTIONS ________________ The most commonly reported adverse reactions (> 5 % subjects) were procedural pain, nausea, constipation, pyrexia, and hypotension,, (6.1) To report SUSPECTED ADVERSE REACTIONS, contact The Medicines Company Support center phone number: 1-888-977-6326or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ___________________________ ___________ USE IN SPECIFIC POPULATIONS ___________ Pregnancy: No human or animal data. Use only if clearly needed. (8.1)See 17 for PATIENT COUNSELING INFORMATIONRevised: 5/2015

RX585834
Rx Item-RAPLIXA (FIBRIN SEALANT (HUMAN))
RX585834

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-RAPLIXA (FIBRIN SEALANT (HUMAN))
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop