Hand Therape Sanitizer

Hand Therape Sanitizer

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

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 in vitro 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 log10) are shown in Table 3 for each virus tested.

Table 3: Cumulative Virus Reduction Factors for Thrombin and Fibrinogen

a HIV-1: Human Immunodeficiency Virus 1, HSV: Herpes Simplex Virus, BVDV: Bovine Viral Diarrhea Virus, CPV: Canine Parvo Virus: a model for B19V, HAV: Hepatitis A Virus, PRV: Pseudorabies Virus

b Additional reduction factor [log10] of 1.6 for PRV not included in cumulative reduction factor for HSV

Cumulative Reduction Factors for Virus Removal/ Inactivation of Human Thrombin
Reduction Factors [log10] of Virus a tested
Manufacturing stepHIV-1HSVBVDVCPVHAV
Pasteurization, precipitation and adsorption steps≥19.6≥21.4≥13.46.68.7
Cumulative Reduction Factors for Virus Removal/ Inactivation of Human Fibrinogen
Reduction Factors [log10] of Virus a tested
Manufacturing stepHIV-1HSVbBVDVCPVHAV
Pasteurization, precipitation and adsorption steps≥9.6≥9.1≥11.2≥4.4≥6.7

Hand Therape Sanitizer Manufacturers


  • Pharmagel International Inc
    Hand Therape Sanitizer (Benzethonium Chloride) Gel [Pharmagel International Inc]

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