Reconstitution

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Mix2Vial™ Instructions for Use

Before handling the components, wash your hands with soap and hot water.

Place the package on a clean, flat surface.

Remove the Flip-Off® buttons from the sterile water and drug product vials.

Disinfect the injection sites with an alcohol swab.

  1. Step 1
    • Remove the top of the Mix2Vial package.
    • Do not remove the device from the package.
  2. Step 2
    • Seat the blue end of the device on the water vial, pushing down until the spike penetrates the rubber stopper and the device snaps in place.
  3. Step 3
    • Remove the plastic package and discard it. Take care not to touch the exposed end of the device.
  4. Step 4
    • Turn the water vial upside down and insert the clear end into the powdered drug vial, pushing down until the spike penetrates the rubber stopper and the device snaps in place.
    • The water will automatically flow into the drug vial.
  5. Step 4b
    • Gently swirl the vial to make sure the product is thoroughly mixed.
  6. Step 5
    • Remove the water vial by turning it counterclockwise.
  7. Step 6
    • Pull back on the syringe plunger and insert it into the luer lock by turning it clockwise.
    • Push down on the plunger to pressurize the vial.
    • Turn the drug vial upside down and withdraw the solution into the syringe.
    • Remove the syringe by turning the barrel counterclockwise.
    • The drug is now ready for administration.
    • Follow normal safety practices to administer the drug.

Flip-Off® is a registered trademark and Mix2Vial™ is a trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.

Indications and Usage for COAGADEX

COAGADEX, a plasma-derived blood coagulation factor X concentrate, is indicated in adults and children with hereditary factor X deficiency for:

Limitation of Use

Perioperative management of bleeding in major surgery in patients with severe hereditary factor X deficiency has not been studied.

Contraindication for COAGADEX

COAGADEX is contraindicated in patients who have had life-threatening hypersensitivity reactions to COAGADEX.

Important Safety Information for COAGADEX

Allergic type hypersensitivity reactions, including anaphylaxis, are possible with COAGADEX. If symptoms occur, patients should discontinue use of the product immediately, contact their physician, and administer appropriate treatment.

The formation of neutralizing antibodies (inhibitors) to factor X is a possible complication in the management of individuals with factor X deficiency. Carefully monitor patients taking COAGADEX for the development of inhibitors by appropriate clinical observations and laboratory tests.

COAGADEX is made from human plasma and may contain infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases, vCJD or CJD, have been associated with the use of COAGADEX.

In clinical studies, the most common adverse reactions (frequency ≥5% of subjects) with COAGADEX were infusion site erythema, infusion site pain, fatigue and back pain.

Please see complete Prescribing Information for COAGADEX.

©Bio Products Laboratory Limited. 2019
COAGADEX® is a registered trademark of Bio Products Laboratory Limited.
Manufactured by: Bio Products Laboratory Limited, Dagger Lane, Elstree, Borehamwood, WD6 3BX, United Kingdom
U.S. License No. 1811 | Code: US/X/0319/0026, Date of Preparation: March 2019

Intended for a U.S. audience only.

IMPORTANT SAFETY INFORMATION