Disclaimer:

Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.

fibrinogen human and thrombin human

×

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


×

Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

RAPLIXA contains a spray-dried mixture of human plasma-derived fibrinogen and human plasma-derived thrombin powders that are designed to mimic the final steps in the coagulation cascade. RAPLIXA dissolves readily on contact with aqueous fluids (e.g., blood) activating thrombin which triggers an immediate conversion of fibrinogen into fibrin, and subsequent clot formation.

Non-Clinical Toxicology
Intravascularly.

For the treatment of severe or brisk arterial bleeding.

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

Ranitidine has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P450 enzymes.









Ranitidine may alter the absorption of drugs in which gastric pH is an important determinant of bioavailability. This can result in either an increase in absorption (e.g., triazolam, midazolam, glipizide) or a decrease in absorption (e.g., ketoconazole, atazanavir, delavirdine, gefitinib). Appropriate clinical monitoring is recommended.





























Life-threatening thromboembolic events may result from intravascular application of RAPLIXA.

The most commonly reported adverse reactions (> 5% subjects) were procedural pain, nausea, constipation, pyrexia, and hypotension.

×

Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

×

Review

Rate this treatment and share your opinion


Learn about User Reviews

Helpful tips to write a good review:

  1. Only share your first hand experience as a consumer or a care giver.
  2. Describe your experience in the Comments area including the benefits, side effects and how it has worked for you. Do not provide personal information like email addresses or telephone numbers.
  3. Fill in the optional information to help other users benefit from your review.

Reason for Taking This Treatment

(required)

Click the stars to rate this treatment

Effectiveness (required)

This medication has worked for me.




Ease of Use (required)

This medication has been easy for me to use.




Satisfaction (required)

Overall, I have been satisfied with my experience.




Write a brief description of your experience with this treatment:

2000 characters remaining

Optional Information

Help others benefit from your review by filling in the information below.
I am a:
Gender:
×

Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
×

Tips

Tips

×

Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).