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For Healthcare ProfessionalsIntended for US Audiences

BAXJECT III Reconstitution System

ADVATE and the diluent come prepackaged in the BAXJECT III reconstitution system.1

Easy to use and easy to train*1,3

  • One-step activation
  • Straightforward pooling process—no additional supplies needed

It’s all connected: all-in-one system minimizes opportunities for reconstitution errors

  • Eliminates the need to disinfect, as vials are already assembled in the system housing – Always ensure patients work on a clean surface and wash their hands before reconstituting
  • With fewer steps, reconstitution with ADVATE [Antihemophilic Factor (Recombinant)] takes about half the time as compared with the BAXJECT II needleless transfer device
BAXJECT III Reconstitution System instructions for use: Press firmly and system will be activated Swirl gently to allow for proper mixing Flip and withdraw

*The below videos are not meant to replace patient training by a healthcare professional. The maximum infusion rate is 10 mL/min.

Watch Reconstitution Demonstration Video with BAXJECT III Reconstitution System

Reconstitution information for ADVATE

For detailed step-by-step instructions for reconstituting ADVATE with BAXJECT III Reconstitution System, watch the video or download the instructions for use.

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ADVATE with BAXJECT III Instructional Video – Video Transcript

Place your infusion materials on a clean, flat surface. Check the expiration date and verify the correct potency to be infused. Allow ADVATE to warm to room temperature. (Examine the packaging containing ADVATE to ensure no damage or peeling of the lid is evident. Do not use if the lid is not completely sealed on the blister. Do not remove ADVATE or diluent vials from the external housing.) Wash your hands. Use of exam gloves is optional, if infusing yourself at home. (Use of exam gloves is optional if self-infusing.) Remove ADVATE with BAXJECT III system from the packaging and by peeling away the lid and set it down on the flat surface with the diluent vial on top. You can identify the diluent vial by the blue stripe. (Do not remove the blue cap until instructed in a later step.) With one hand holding the ADVATE housing, press down firmly on the diluent vial with the other hand (Perform on a clean flat surface. Do not tilt the system until the diluent transfer is complete.) until the system is fully collapsed and the diluent flows down into the ADVATE vial. Swirl gently until the ADVATE is completely dissolved. (Do not shake. Do not refrigerate after reconstitution.) The solution should be clear and colorless. (If the solution is not clear and colorless in appearance, do not use the solution, and notify your healthcare provider.) Remove the blue cap. Take the syringe and push the plunger way in. Screw the syringe into the system. (Be careful not to inject air into the ADVATE with BAXJECT III system.) and turn the system over so that the diluent vial with the blue stripe is on the bottom and the vial containing ADVATE solution is on top. Slowly draw the solution into the syringe. Be careful not to inject air into the system. (Reconstituted product (after mixing dry product with diluent) must be used within 3 hours and cannot be stored or refrigerated.) It is acceptable for a small amount of liquid to remain in the vial. Once you’ve collected the reconstituted ADVATE you are ready to continue with the infusion process. (Do not infuse any faster than 10 mL per minute over a period of ≤ 5 minutes. Dispose of the used syringe and BAXJECT III system in a sharps container. Please see ADVATE with BAXJECT III troubleshooting video if you have difficulty with reconstitution. Important: Contact your healthcare provider or local hemophilia treatment center if you experience further problems.)

Watch Reconstitution Troubleshooting Video with BAXJECT III Reconstitution System

Troubleshooting information for ADVATE

Watch the demonstration and download the troubleshooting guide to learn how to recover ADVATE if the initial reconstitution procedure does not work.

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ADVATE with BAXJECT III System Troubleshooting Guide – Video Transcript

The following instructions will guide you through recovering ADVATE with BAXJECT III if the initial reconstitution procedure does not work.

Reasons why there might be a diluent transfer difficulty:

If you activated the ADVATE with BAXJECT III system upside down (blue stripe at bottom). If the system is tilted while diluent is transferring. If the blue cap located on the side of the system is removed before activating the system. If you have injected air into the system in error. If you did not press down hard enough to activate.

First, make sure ADVATE with BAXJECT III system is in the correct orientation on a clean flat surface with the diluent vial on top. (Keep the system on a clean, flat surface.) The diluent vial has the blue stripe. (Make sure that the blue stripe is on top.) Also on a clean flat surface, make sure the product and diluent vials are fully activated and pressed into the white plastic housing. (Push the diluent vial down as far as it will go into the white housing.) Remove from the blue cap on the side. (Do not remove the blue cap until the diluent vial has been pushed all the way into the white housing.) Press the plunger to expel any air from the syringe. Screw the syringe into the system. Pull the plunger back slowly to withdraw air from the vials. (Be careful not to inject air into the ADVATE with BAXJECT III system.) This will force the diluent into the ADVATE vial. Do not tilt the system until the diluent transfer is complete. Disconnect the syringe from the system. Swirl gently until the ADVATE is completely dissolved. (Do not shake. Do not refrigerate after reconstitution.) The solution should be clear and colorless. (If the solution is not clear and colorless in appearance, do not use the solution, and notify your healthcare provider.) Again, press the plunger to expel any air from the syringe. (Do not inject air into the ADVATE with BAXJECT III system.) Reconnect the syringe to the side of the system and turn the system over so that the diluent vial with the blue stripe is at the bottom. (Be careful not to inject air into the ADVATE with BAXJECT III system.) Slowly draw the solution into the syringe. Be careful not to inject air into the system. (Do not inject air into the ADVATE with BAXJECT III system.) It is acceptable for a small amount of liquid to remain in the vial. (Reconstituted product (after mixing dry product with diluent) must be used within 3 hours and cannot be stored or refrigerated.) Once you’ve collected the reconstituted ADVATE, you are ready to continue with the infusion process. (Do not infuse faster than 10 mL per minute over a period of ≤ 5 minutes. Dispose of the used syringe and BAXJECT III system in a sharps container.) If these steps fail to address the problems you are having, please contact your healthcare provider or local hemophilia treatment center.