How to prepare and reconstitute with BIO-SET®

  • Information and instructions on preparing and administering Kogenate FS with BIO-SET.

    Always work on a clean surface and wash your hands before performing the following procedure.

    1
  • Information and instructions on preparing and administering Kogenate FS with BIO-SET Step #2.

    Open
    The easiest way to remove the cap from the vials is to move the top from side-to-side while pulling upward at the same time. This breaks the small plastic tabs that connect the cap to the top of the vial.

    2
  • Information and instructions on preparing and administering Kogenate FS with BIO-SET Step #3.

    Remove Tip Cap
    Remove the tamper-evident tip cap from the syringe. Separate the tip cap from the syringe by gently breaking it off. Hold the syringe in one hand while snapping off the tip cap with the other hand. Do not try to twist it off. Move it from side to side.

    3
  • Information and instructions on preparing and administering Kogenate FS with BIO-SET Step #4.

    Connect Syringe
    Connect the prefilled syringe to the powder vial by gently screwing it on clockwise on to the top of the vial until finger tight. Do not overtighten.

    4
  • Information and instructions on preparing and administering Kogenate FS with BIO-SET Step #5.

    Activate (Spike the Vial)
    Place the vial on a solid, non-skid surface. Hold the vial firmly with one hand. With the other hand, place your thumb and forefinger on the fingerplate of the syringe and press down firmly on the fingerplate until it meets the top of the powder vial. This is the most critical step in the process. If the syringe is not pushed down firmly enough, the system will not be fully activated.

    5
  • Information and instructions on preparing and administering Kogenate FS with BIO-SET Step #6.

    Connect Plunger Rod
    Grasp the plunger rod at the top. Avoid contact with the rest of the plunger rod. Immediately connect it to the syringe by screwing the plunger rod clockwise into the rubber stopper.

    6
  • Information and instructions on preparing and administering Kogenate FS with BIO-SET Step #7.

    Inject
    Inject diluent into the vial by slowly pressing down the plunger rod. Pushing down the syringe too quickly may cause foaming in the vial. If this occurs, wait until the foam subsides before continuing.

    7
  • Information and instructions on preparing and administering Kogenate FS with BIO-SET Step #8.

    Mix
    Mix the diluent and powder by swirling gently and slowly. DO NOT SHAKE THE VIAL. Be sure the powder is completely dissolved before using.

    8
  • Information and instructions on preparing and administering Kogenate FS with BIO-SET Step #9a.

    Transfer
    Invert the vial, with the syringe still attached and smoothly draw all the solution into the syringe.

    9a
  • Information and instructions on preparing and administering Kogenate FS with BIO-SET Step #9b.

    Transfer (continued)
    Tilt the vial to the side and back to check that all remaining solution has been drawn into the large opening in the rubber stopper.

    9b
  • Information and instructions on preparing and administering Kogenate FS with BIO-SET Step #10.

    Disconnect
    Disconnect the syringe from the empty vial by unscrewing it counterclockwise. DO NOT PULL THE SYRINGE FROM THE VIAL WITHOUT UNSCREWING IT FIRST.

    10
  • Information and instructions on preparing and administering Kogenate FS with BIO-SET Step #11.

    Infuse
    Attach the syringe to the butterfly set by screwing it in clockwise and follow the infusion instructions provided with Kogenate FS with BIO-SET.

    11

Kogenate FS with BIO-SET Instructions for Use

These procedures are provided as general guidelines for the reconstitution and administration of Kogenate® FS, Antihemophilic Factor (Recombinant) with BIO-SET, a needleless self-contained reconstitution system. Always work on a clean surface and wash your hands before performing the following procedure. Use only the components for reconstitution and administration that are provided with each package of Kogenate FS. If a package is opened or damaged, do not use this component. If these components cannot be used, please contact your healthcare provider. If you have any questions about Kogenate FS contact Bayer at 1-888-84-BAYER (1-888-842-2937).

Dosing Kogenate FS

Kogenate FS comes in a variety of vial sizes because different people, types of bleeds and circumstances require different dosages. Work with your doctor to determine how much Kogenate FS you need and when.

Learn more about dosing Kogenate FS

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