e adapter will snap over the vial cap. Do not remove the adapter housing at this step.
3BB
4. Holding the syringe by the barrel, snap the syringe cap off the tip (C). Do not touch the syringe tip with your hand or any surface. Set the syringe aside for further use.
4CC
5. Now remove and discard the adapter plastic housing (D).
5DD
6. Attach the prefilled syringe to the vial adapter thread by turning clockwise (E).
6EE
7. Remove the clear plastic plunger rod from the carton. Grasp the plunger rod by the top plate. Avoid touching the sides and threads of the plunger rod. Attach the plunger rod by turning it clockwise into the threaded rubber stopper of the prefilled syringe (F).
7FF
8. Inject the diluent slowly by pushing down on the plunger rod (G).
8GG
9. Swirl vial gently until all powder on all sides of the vial is dissolved (H). Do not shake vial. Be sure that all powder is completely dissolved. Do not use if solution contains visible particles or is cloudy.
9HH
10. Push down on the plunger to push all air back into the vial. Then while holding the plunger down, turn the vial with syringe upside-down (invert) so the vial is now above the syringe (I).
10II
11. Withdraw all the solution into the syringe by pulling the plunger rod back slowly and smoothly (J). Tilt the vial to the side and back to make sure all the solution has been drawn toward the large opening in the rubber stopper and into the syringe. Remove as much air as possible before removing the syringe from the vial by slowly and carefully pushing the air back into the vial.
11JJ
12. Detach the syringe with plunger rod from the vial adapter by turning counter-clockwise. Attach the syringe to the administration set provided and inject intravenously (K). NOTE: follow instructions for infusion set provided.
12KK
Pooling
If the dose requires more than one vial, reconstitute each vial as described above with the diluent syringe provided. To combine the content of the vials, use a larger plastic syringe (not provided) to pool the solution into the syringe and administer as usual.
Rate of Administration
The entire dose of KOVALTRY can usually be infused within 1 to 15 minutes. Your healthcare provider will determine the rate of administration that is best for you.
Resources at Bayer available to the patient:
For Adverse Reaction Reporting, contact Bayer Medical Communications 1-888-84-BAYER (1-888-842-2937)
To receive more product information, contact KOVALTRY Customer Service 1-888-606-3780
Bayer Reimbursement HELPline 1-800-288-8374
For more information, visit WWW.KOVALTRY-US.COM
Bayer HealthCare LLC
Whippany, NJ 07981 USA
U.S. License No. 8
PRINCIPAL DISPLAY PANEL
NDC 0026-3821-25
Kovaltry 250 IU Range
Antihemophilic Factor (Recombinant)
Recombinant Factor VIII
with Vial Adapter
For Intravenous Use Only
Needleless Reconstitution Set
250 Carton
PRINCIPAL DISPLAY PANEL
NDC 0026-3822-25
Kovaltry 500 IU Range
Antihemophilic Factor (Recombinant)
Recombinant Factor VIII
with Vial Adapter
For Intravenous Use Only
Needleless Reconstitution Set
500 Carton
PRINCIPAL DISPLAY PANEL
NDC 0026-3824-25
Kovaltry 1000 IU Range
Antihemophilic Factor (Recombinant)
Recombinant Factor VIII
with Vial Adapter
For Intravenous Use Only
Needleless Reconstitution Set
1000 Carton
PRINCIPAL DISPLAY PANEL
NDC 0026-3826-50
Kovaltry 2000 IU Range
Antihemophilic Fac |
