XYNTHA SOLOFUSE /ZIN-tha/ [Antihemophilic Factor (Recombinant)]
XYNTHA SOLOFUSE is supplied as a pre-filled dual-chamber syringe with lyophilized XYNTHA powder in one chamber and 0.9% sodium chloride solution in the other chamber. Before you can infuse it (intravenous injection), you must reconstitute the powder by mixing it with the sodium chloride solution.
Reconstitute and infuse XYNTHA SOLOFUSE using the infusion set provided in this kit. Please follow the directions below for the proper use of this product.
PREPARATION AND RECONSTITUTION OF XYNTHA SOLOFUSE
INFUSION OF XYNTHA
Your healthcare provider will teach you how to infuse XYNTHA yourself. Once you learn how to do this, you can follow the instructions in this insert.
Before XYNTHA can be infused, you must reconstitute it as instructed above in the PREPARATION AND RECONSTITUTION OF XYNTHA SOLOFUSE section.
After reconstitution, be sure to look carefully at the XYNTHA solution. The solution should be clear to slightly opalescent and colorless. If it is not, throw away the solution and use a new kit.
Use the infusion set included in the kit to infuse XYNTHA. Do not infuse XYNTHA in the same tubing or container with other medicines.
XYNTHA is also supplied in kits that include single-use vials with lyophilized powder and prefilled diluent syringes.
If you use one XYNTHA vial and one XYNTHA SOLOFUSE for the infusion, reconstitute the XYNTHA vial and the XYNTHA SOLOFUSE according to the specific directions for that respective product kit. Use a separate, 10 milliliter or larger luer lock syringe (not included in this kit) to draw back the reconstituted contents of the XYNTHA vial and the XYNTHA SOLOFUSE.
If you use multiple XYNTHA SOLOFUSE kits for the infusion, reconstitute each XYNTHA SOLOFUSE according to the directions above. Use a separate, 10 milliliter or larger luer lock syringe (not included in this kit) to draw back the reconstituted contents of any additional XYNTHA SOLOFUSE.
Use of a XYNTHA Vial Kit with a XYNTHA SOLOFUSE Kit
These instructions are for the use of only one XYNTHA vial kit with one XYNTHA SOLOFUSE Kit. For further information, please contact your healthcare provider or call the Medical Information Department at Wyeth Pharmaceuticals, 1-800-438-1985.
Note: Dispose of all unused solution, the empty XYNTHA SOLOFUSE, and other used medical supplies in an appropriate container.
Use of Multiple XYNTHA SOLOFUSE Kits
The instructions below are for the use of multiple XYNTHA SOLOFUSE kits with a 10 milliliter or larger luer lock syringe. For further information, please contact your healthcare provider or call the Medical Information Department at Wyeth Pharmaceuticals, 1-800-438-1985.
Note: Luer-to-luer syringe connectors are not provided in the kits. Contact your XYNTHA supplier to order.
This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
License no: 3 LAB-0500-13.0
Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.
*Contact Medical Information. 8AM-9PM ET Monday to Friday; excluding holidays.
Submit a medical question for Pfizer prescription products.
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are
not part of a clinical trial* for this product, click the link below to submit your
*If you are involved in a clinical trial for this product, adverse
events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related
to a different Pfizer product, please call Pfizer Safety at
You may also contact the U.S. Food and Drug Administration (FDA) directly to report
adverse events or product quality concerns either online at