• Grasp the plunger rod as shown. Avoid contact with the shaft of the plunger rod.

• Screw plunger rod fi rmly into opening in fi nger rest of SOLOFUSE.

• Turn plunger fi rmly until you feel resistance (about 2 turns).

• Advance plunger gently and slowly until both stoppers inside SOLOFUSE meet and all diluent has transferred to the XYNTHA powder chamber.

• Hold SOLOFUSE upright and remove white tamper-evident seal by bending it right to left to break cap perforation and expose grey rubber tip cap.

• Keep syringe upright throughout reconstitution process.

• Keeping SOLOFUSE upright, swirl gently until the powder is dissolved.

• Remove blue vented cap from package.

• Remove grey rubber tip cap from SOLOFUSE and replace with blue cap.

• Avoid touching open end of both SOLOFUSE and blue cap.

• Advance plunger rod slowly until most but not all air is removed from XYNTHA chamber.

• Remove blue vented cap and attach infusion set.

XYNTHA (moroctocog alfa) is used for the control and treatment of bleeding and the routine and surgical prevention of bleeding in people with hemophilia A. XYNTHA should not be used for the treatment of other clotting factor defi ciencies such as von Willebrand’s disease or hemophilia B.

XYNTHA may cause allergic reactions. Signs of allergy include hives (rash with itching), chest tightness, diffi culty 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 heartbeat, sweating, drowsiness, muscle weakness, loss of appetite, muscle pain, pain, coughing, shortness of breath, diarrhea, stomach cramps, altered taste, injection site pain or infl ammation and weakness. Uncommon or rare side effects are headache, fever, nausea, vomiting, chills, and fl ushing (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.

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Use this placemat for general guidelines on using XYNTHA SOLOFUSE, and on combining a XYNTHA Rapid Reconstitution (R2) vial kit with SOLOFUSE or combining multiple SOLOFUSE syringes. Always follow the specifi c preparation and administration procedures provided by your hemophilia treatment centre.

Whether you are using XYNTHA SOLOFUSE on its own or combining it with an R2 vial or another SOLOFUSE syringe, you must:

Always use germ-free methods when preparing and infusing XYNTHA. Use all XYNTHA kit materials as soon as possible after opening the sterile containers.

ADDING another XYNTHA SOLOFUSE or a XYNTHA R2 vial? Turn over for guidance.!

PREPARING

✓ Remove XYNTHA from the refrigerator and allow it to come to room temperature.

✓ Wash your hands with good soapy lather for at least 30 seconds.

✓ Infuse reconstituted XYNTHA within 3 hours of mixing. If not used immediately, the syringe should be stored upright and the protective blue vent cap should remain on the device until ready to infuse.

✓ Dispose of all unused solution, SOLOFUSE syringes, vials, and other medical supplies in an appropriate container used for throwing away waste that might hurt others if not handled properly.

✓ Ensure the XYNTHA solution is colourless, clear to slightly pearly, and contains no particulate matter. If it is not, the solution should be discarded and a new kit should be used.

D000051640E

You may need to combine a XYNTHA vial and a XYNTHA SOLOFUSE syringe to achieve your required dose. These instructions are for combining one vial and one SOLOFUSE.

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Combining XYNTHA SOLOFUSE with XYNTHA R2 vial

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© 2015 P� zer Canada Inc.Kirkland, Quebec H9J 2M5www.p� zer.ca

XYNTHA ® Wyeth LLC, owner/P� zer Canada Inc., Licensee SOLOFUSE ® Wyeth LLC, owner/P� zer Canada Inc., Licensee® P� zer Inc., used under license

• Reconstitute all required XYNTHA SOLOFUSE syringes following steps 1–6 on the front of this placemat.

• Remove luer-to-luer syringe connector from package.

• Remove blue vented cap from SOLOFUSE.• Connect sterile 10 cc (or larger)

luer lock syringe to one opening (port) in syringe connector.

• Connect SOLOFUSE to other port.

• With SOLOFUSE on top, depress plunger slowly until contents empty into the 10 cc (or larger) luer lock syringe.

• Remove empty SOLOFUSE and repeat steps 2 and 3 with remaining reconstituted SOLOFUSE syringes.

• Remove luer-to-luer syringe connector from 10 cc (or larger) luer lock syringe.

• Attach infusion set.

Combining multiple XYNTHA SOLOFUSE syringes

You may need to combine multiple XYNTHA SOLOFUSE syringes to achieve your required dose.

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STARTING preparation? Turn over for guidance.

Luer-to-luer syringe connectors are readily available at your Hemophilia Treatment Centre, or you can order them free of charge by calling Shoppers Drug Mart Specialty Health Network at 1-855-212-3788.

• Reconstitute XYNTHA vial following instructions on package insert.

• Detach empty syringe from vial adapter (gently turn and pull syringe counter-clockwise).

• Leave vial contents and vial adapter in place.

• Detach empty SOLOFUSE from vial and discard it.

• If syringe turns but does not detach, grasp white collar and turn.

• Connect sterile 10 cc (or larger) luer lock syringe to vial adapter.

• Inject some air into vial to facilitate withdrawal of contents.

• Invert vial and slowly draw solution into the 10 cc (or larger) luer lock syringe.

• Gently turn and pull syringe counter-clockwise to detach syringe from vial adapter.

• Discard vial with adapter attached.

• Attach infusion set to 10 cc (or larger) luer lock syringe for infusion.

• Reconstitute XYNTHA SOLOFUSE using steps 1 to 6 on the other side of this placemat, and remove blue vented cap.

• Connect SOLOFUSE to vial adapter by inserting tip into adapter opening while turning syringe clockwise until secured.

• Depress SOLOFUSE plunger slowly until contents empty into vial.

• Plunger rod may move back slightly after release.