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fibrinogen human and thrombin human

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Overview

What is Raplixa?

RAPLIXA is a fibrin sealant comprised of human plasma-derived fibrinogen and thrombin that is designed to be used as an adjunct to surgical hemostasis. Each component is separately spray dried with trehalose followed by blending the two components to provide a ready-to-use, pre-mixed, sterile, dry powder that is filled in sterile medical grade glass vials. RAPLIXA is manufactured aseptically, resulting in a sterile product in a sterile vial. RAPLIXA does not contain any preservatives.

Except for fibrinogen and thrombin, the product contains the following components added during the manufacturing: trehalose – 824 mg/g, calcium chloride – 11 mg/g, and traces of the components from the formulations of fibrinogen and thrombin raw materials: human albumin, sodium chloride, sodium citrate, and L-Arginine hydrochloride.

Viral Clearance

All human plasma used in the manufacture of RAPLIXA is tested for the presence of current specific virus infections using FDA-licensed serological assays and nucleic acid testing (NAT) assays for HBV, HIV-1/2, and HCV and found to be non-reactive (negative). The manufacturing procedures for fibrinogen and thrombin include processing steps designed to reduce the risk of viral transmission, including pasteurization, precipitation and adsorption steps.

Validation studies for fibrinogen and thrombin manufacturing steps were conducted for their capacity to inactivate and/or remove viruses. These validation studies were conducted, using samples from manufacturing intermediates spiked with virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The cumulative virus reduction factors (expressed as log) are shown in Table 3 for each virus tested.



What does Raplixa look like?



What are the available doses of Raplixa?

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. ()

What should I talk to my health care provider before I take Raplixa?

Pregnancy: No human or animal data. Use only if clearly needed. ()

How should I use Raplixa?

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 may be applied directly or using the RaplixaSpray device.

For topical use only.

Do not reconstitute. Use within one hour of opening.


What interacts with Raplixa?

Sorry No Records found


What are the warnings of Raplixa?

Sorry No Records found


What are the precautions of Raplixa?

Sorry No Records found


What are the side effects of Raplixa?

Sorry No records found


What should I look out for while using Raplixa?

Intravascularly.

For the treatment of severe or brisk arterial bleeding.

In patients known to have anaphylactic or severe systemic reactions to human blood products. ()


What might happen if I take too much Raplixa?

Sorry No Records found


How should I store and handle Raplixa?

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light. How SuppliedThe RAPLIXA powder is supplied in sterile medical grade single-use glass vials with rubber stopper and aluminum tear-off crimp seal with a white polypropylene flip-off, packaged in an aluminum pouch, and contains no preservative. RAPLIXA is supplied in three different presentations: 0.5 gram (NDC 62238-008-01), 1 gram (NDC 62238-008-02), and 2 gram (NDC 62238-008-03) vials. Storage and Handling How SuppliedThe RAPLIXA powder is supplied in sterile medical grade single-use glass vials with rubber stopper and aluminum tear-off crimp seal with a white polypropylene flip-off, packaged in an aluminum pouch, and contains no preservative. RAPLIXA is supplied in three different presentations: 0.5 gram (NDC 62238-008-01), 1 gram (NDC 62238-008-02), and 2 gram (NDC 62238-008-03) vials. Storage and Handling How SuppliedThe RAPLIXA powder is supplied in sterile medical grade single-use glass vials with rubber stopper and aluminum tear-off crimp seal with a white polypropylene flip-off, packaged in an aluminum pouch, and contains no preservative. RAPLIXA is supplied in three different presentations: 0.5 gram (NDC 62238-008-01), 1 gram (NDC 62238-008-02), and 2 gram (NDC 62238-008-03) vials. Storage and Handling How SuppliedThe RAPLIXA powder is supplied in sterile medical grade single-use glass vials with rubber stopper and aluminum tear-off crimp seal with a white polypropylene flip-off, packaged in an aluminum pouch, and contains no preservative. RAPLIXA is supplied in three different presentations: 0.5 gram (NDC 62238-008-01), 1 gram (NDC 62238-008-02), and 2 gram (NDC 62238-008-03) vials. Storage and Handling