Always use germ-free methods during the preparation and administration of Xyntha. This means using all the materials from your R2 kit as soon as possible after opening the sterile containers.

• Remove Xyntha from refrigerator.

• Allow to come to room temperature.

• Wash your hands with good soapy lather for a minimum of 30 seconds.

• Remove plastic flip top cap.

• Wipe top of vial with alcohol swab.

• Remove cover from plastic vial adapter package.

• Place adapter over Xyntha vial, press down firmly until it snaps into place.

• Leave plastic cover on adapter until you are ready to connect the syringe.

• Attach plunger rod to diluent syringe by inserting the rod into the syringe and turning.

• Remove plastic cap from diluent syringe by bending up and down to break the seal.

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• Remove plastic cover on vial adapter.

• Connect the syringe to adapter on Xyntha vial.

• Insert tip of syringe into adapter opening.

• Push firmly and turn in a clockwise direction.

• Slowly push down plunger of syringe to inject all diluent into Xyntha vial.

• Don’t remove syringe.

• Gently swirl vial until all the Xyntha powder is dissolved.

• Solution should be clear to slightly pearly and colourless.

• Invert vial, slowly draw reconstituted Xyntha into syringe.

• Remove syringe from vial by pulling and turning counter clockwise.

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• Prepare all the vials of Xyntha you need, leaving the diluent syringes attached until you are ready to draw back the solution.

• Remove all the diluent syringes from the vial adapters, leaving the vial adapters in place.

• Remove the large luer lock syringe from the packaging and attach it to the vial adapter and draw back the Xyntha solution as in step 11.

• Transfer the large luer lock syringe to the next vial adapter to draw back this Xyntha solution.

• Repeat these steps with as many vials as required.

• After preparing Xyntha it should be injected intravenously over several minutes, as directed by your hemophilia treatment centre.

If using more than one vial:

The following steps are provided as general guidelines for using the Xyntha R2 Kit. Always follow the specific preparation and administration procedures provided by your hemophilia treatment centre.

Talk to your doctor or hemophilia treatment centre if you have any questions about Xyntha.

Preparing XYNTHA using the R2 KitRAPID

RECONSTITUTION

D000055352

© 2016 Pfizer Canada Inc. Kirkland, Quebec H9J 2M5 www.pfizer.ca

XYNTHA®, Wyeth LLC, owner/Pfizer Canada Inc., Licensee

® Pfizer Inc., used under license

Xyntha is indicated for the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia). Xyntha does not contain von Willebrand factor and hence is not indicated in von Willebrand’s disease.

Xyntha may cause allergic reactions. Signs of allergy include hives (rash with itching), chest tightness, difficulty breathing, wheezing, dizziness, faintness, swollen face and rapid heart rate. If any of these symptoms occur, stop using Xyntha immediately and contact your hemophilia doctor or seek emergency medical care. The initial infusions of Xyntha should be administered under proper medical supervision, where proper medical care for allergic reactions could be provided.

Some side effects of Xyntha include cold sensation, chest pain, rapid heart beat, sweating, drowsiness, muscle weakness, loss of appetite, muscle pain, pain, coughing, shortness of breath, diarrhea, stomach cramps, altered taste, injection site pain or inflammation and weakness. Uncommon or rare side effects are headache, fever, nausea, vomiting, chills, and flushing (skin turning red). If any of these symptoms occur, stop using Xyntha and call your hemophilia doctor. If your bleeding does not stop as you expect after using Xyntha, or if you are using increasing amounts of Xyntha to control your bleeding, talk to your hemophilia doctor.

Notify your hemophilia doctor if you are unable to prevent or control episodes of bleeding with your normal dose of Xyntha. Your body may produce inhibitors against Xyntha. Inhibitors are antibodies produced by your immune system that can prevent Xyntha from working properly. Check with your hemophilia doctor to make sure you are closely monitored with blood tests for the presence of inhibitors.