Profibrix Bv

Profibrix Bv Drugs

• Hand Therape Sanitizer
  

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  Hand Therape Sanitizer

  

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  For topical use only.

  Do not reconstitute. Use within one hour of opening.

  2.1 Dose

  The 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 Administration

  Applying 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).

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