How to use it
Patient information
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Summary of Product Characteristics Prescribing Information Patient Information LeafletBIO-SET® is the needleless reconstitution device that you use to mix your KOGENATE® Bayer.
Always follow your haemophilia doctor or nurse's instructions carefully.
Always wash your hands thoroughly with soap and warm water before the following procedure. Clean and germ free conditions are required during reconstitution and infusion.
Open
Step 1
Remove cap from the vial by firmly pressing your thumb against the side of the cap pressing it away from you with a slight upward move to break the small plastic tabs.
Or, move top from side to
side,while pulling upward
at the same time.Remove Tip Cap
Step 2
Connect Syringe
Step 3
Remove tamper-evident
tip cap from the syringe.
Connect pre-filled syringe
to powder vial by gently
screwing it on.
Activate
Step 4
Place vial on a solid non-slip 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 on the fingerplate until it
meets the top of the powder vial.
THIS IS THE MOST CRITICAL STEP IN THE PROCESS
THIS IS THE MOST CRITICAL STEP IN THE PROCESS

Connect Plunger Rod
Step 5
Inject
Step 6
Grasp the plunger rod
at the top and remove it
from the box.Immediately
connect it to the syringe
by screwing it into the
rubber stopper.
Inject water into the vial
by slowly pressing down
the plunger.Mix
Step 7
Transfer
Step 8
Mix by swirling gently
and slowly.DO NOT SHAKE
THE VIAL.
Be sure the powder is completely dissolved before using.
Invert the vial with the
syringe still attached and
draw the solution into
the syringe. Tilt the vial to the side
so remaining solution is
drawn into the opening
in the rubber stopper.
Disconnect
Step 9
Infuse
Step 10
Disconnect the syringe
from the empty vial by
unscrewing it.DO NOT PULL THE SYRINGE FROM THE VIAL WITHOUT UNSCREWING IT.
Attach the syringe to
the butterfly set by
screwing it in clockwise,
and then follow your
normal infusion
procedure.It is necessary to use the butterfly in the BIO-SET® administration kit because it has an inbuilt filter.
BIO-SET® is a needleless reconstitution system and trademark of Biodome SAS.
NEW Safety Butterfly
For more
information on the
new safety butterfly® click here