Terumo Bct Ltd

Terumo Bct Ltd Drugs

• Isoplate
  

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  Isoplate

  

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  2.1 General Dosing Information

  ISOPLATE SOLUTION is added to hyperconcentrated platelets after the apheresis procedure is complete. It is not intended for direct intravenous infusion.

  ISOPLATE SOLUTION may only be used with the Trima Accel system for automated blood collection. For instructions on the use of the solution with the Trima Accel system, see the Trima Accel system operator's manual.

  2.2 Administration

  Ensure solution is the ISOPLATE SOLUTION and is within the expiration date. Inspect the bag. Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. Use only if solution is clear and free of particulate matter. Protect from sharp objects.

  Directions for Connecting the ISOPLATE SOLUTION Bag to the Trima Accel System

  At the prompt to connect the platelet additive solution to the Trima Accel system tubing set:

  Remove the overwrap by pulling down at notch, and remove the ISOPLATE SOLUTION bag. Before use, perform the following checks [See Warnings and Precautions (5).]: Check for leaks by squeezing the bag. If leaks are found, discard bag. Ensure the solution is the ISOPLATE SOLUTION and is within the expiration date. Inspect the solution in good light. Bags showing cloudiness, haze, or particulate matter should not be used. Remove the protective cap from the port on the bag. Connect the bag to the Trima Accel system tubing set using aseptic technique and hang the solution. Break the frangible connector. When you break frangible connectors, bend them in both directions to ensure that you break them completely. Failure to do so may result in restricted flow. Proceed per the Trima Accel system operator's manual.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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