Hand Therape Sanitizer
Loading...Hand Therape Sanitizer Recall
Get an alert when a recall is issued.
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.
| 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 step | HIV-1 | HSV | BVDV | CPV | HAV |
| Pasteurization, precipitation and adsorption steps | ≥19.6 | ≥21.4 | ≥13.4 | 6.6 | 8.7 |
| Cumulative Reduction Factors for Virus Removal/ Inactivation of Human Fibrinogen | |||||
| Reduction Factors [log10] of Virus a tested | |||||
| Manufacturing step | HIV-1 | HSVb | BVDV | CPV | HAV |
| Pasteurization, precipitation and adsorption steps | ≥9.6 | ≥9.1 | ≥11.2 | ≥4.4 | ≥6.7 |
Sources
Hand Therape Sanitizer Manufacturers
-
Pharmagel International Inc
![Hand Therape Sanitizer (Benzethonium Chloride) Gel [Pharmagel International Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hand Therape Sanitizer | Profibrix Bv
For topical use only.
Do not reconstitute. Use within one hour of opening.
2.1 DoseThe required amount of Raplixa needed to stop bleeding varies and is based on the size of the bleeding area to be treated. The maximum total dose of Raplixa per surgery is 3 grams. In clinical trials, it was demonstrated that smaller bleeding sites covering an area of less than 10 cm2 used 0.5 gram to 1.0 gram of Raplixa. Larger bleeding sites covering an area of 10-100 cm2 used 1.0 to 2.0 grams of Raplixa to stop bleeding. Using the RaplixaSpray device, 1.0 gram can cover a 100 cm2 bleeding surface area.
The required dose of Raplixa depends on the size of the bleeding area to be treated according to Table 1 below.
Table 1: Guideline for Raplixa Application Maximum Surface Area
Direct Application from Vial Maximum Surface Area
Application Using RaplixaSpray Device Raplixa Package Size 25 cm2 50 cm2 0.5 g 50 cm2 100 cm2 1 g 100 cm2 200 cm2 2 g 2.2 AdministrationApplying to the surface of bleeding tissue only, administer Raplixa directly from the vial or using the RaplixaSpray 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.
Direct Application of Raplixa with Absorbable Gelatin Sponge (USP)
Note: Refer to Absorbable Gelatin Sponge (USP) labeling for complete instructions for use.
1. Open the pouch and take out the Raplixa vial following standard sterile technique to ensure that the vial and surgical field remain sterile.
2. Check that the powder is in the bottom of the vial. Remove the flip-off top, leaving the stopper in place until immediately prior to use.
3. Prepare sterile gelatin sponge by trimming to an appropriate size for the bleeding site.
4. Remove stopper and sprinkle a uniform thin coating of Raplixa gently onto bleeding site and apply gentle pressure with gelatin sponge using sterile gauze.
OR
1. Remove stopper and sprinkle a thin layer of Raplixa gently onto a pre-wetted gelatin sponge and place onto the bleeding site with gentle pressure using sterile gauze.
Preparation and Application of Raplixa Using the RaplixaSpray Device with Absorbable Gelatin Sponge (USP)
Note: Refer to the RaplixaSpray Device labeling for complete instructions for use. Refer to Absorbable Gelatin Sponge (USP) labeling for complete instructions for use.
1. Prepare the pressure regulator (Air or CO2) according to the manufacturer’s instructions for use.
2. Open the pouch and take out the Raplixa vial following standard sterile technique to ensure that the vial and surgical field remain sterile.
3. Check that the powder is in the bottom of the vial. Remove the flip-off top, leaving the stopper in place until use.
4. Prepare gelatin sponge by trimming to an appropriate size for the bleeding site.
5. To attach the vial to the RaplixaSpray device, invert the device and place the upright vial into the gray rubber ring on the device, turn the device upright and return the device to the sterile field until use.
6. Activate air or gas flow.
7. Device is now ready for use. DO NOT push button until ready for use.
8. Check that the pressure is 1.5 bar (22 psi).
9. Ensure the vial is kept within 45° of vertical at all times.
10. Hold nozzle at a minimum distance of 5 cm (or 2 inches) from the bleeding site.
11. Start application by gently pressing the operating button.
12. Powder should cover the bleeding surface as a uniform thin coating. Apply Raplixa within 10-60 seconds.
13. Immediately after Raplixa application, place a gelatin sponge, trimmed to the approximate size, on top of the Raplixa powder. The gelatin sponge may be used dry or moistened with sterile saline. A moistened sponge molds more easily to irregularly-shaped and contoured bleeding areas. Hold the gelatin sponge in place with manual pressure using sterile gauze.
14. Hold the device upside down and carefully remove the empty vial. If needed, attach the second vial (repeat steps 1-14). Use no more than two vials of Raplixa with the RaplixaSpray device.
15. To administer a third vial, open a new RaplixaSpray delivery device (repeat steps 1-13).
Login To Your Free Account