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U.S. Department of Health and Human Services

Safety

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Delflex Peritoneal Dialysis (PD) Solutions

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

including:

  • Delflex Peritoneal Dialysis (PD) Solutions (1.5%, 2.5% and 4.25% Dextrose with Standard Calcium/Standard Magnesium and with Standard Calcium/Low Magnesium)
  • Delflex PD Solutions (1.5%, 2.5% and 4.25% Dextrose with Low Calcium/Low Magnesium)

 

April 2014

Summary View

For Conventional Delflex Single Bag and Double Bag:

WARNINGS

  • After removing the outerwrap, check for minute leaks by squeezing the solution bag firmly. If leaks are found, discard the solution because the sterility may be impaired. (A small amount of moisture may be present inside the outerwrap, which is normal condensation from the sterilization process).

PRECAUTIONS

Information for Patients
  • Administer only if the solution is clear, all seals are intact, and there is no evidence of leaking
  • Care should be taken to ensure that there is not any leakage around the catheter, since if not controlled, the leakage can create edema from subcutaneous infiltration of the dialysis solution. The leakage will also create an inaccurate fluid balance measurement. If any leakage is identified do not proceed with infusion and notify your physician.
  • The outerwrap should remain intact until time of use
  • Do not heat in a microwave oven. Microwave ovens heat unevenly and can leave hot spots, which can burn the peritoneum.


Additionally - for Conventional DELFLEX Double Bag only:

PRECAUTIONS

  • Chronic patients that have been stabilized on peritoneal dialysis therapy should have routine evaluation of electrolyte blood chemistries and hematologic factors measured in order to determine the patient's ongoing condition.
  • Disconnect from disk only when knob is in position 4 (••••) to ensure patient connector is sealed
  • Additives may be incompatible. Please refer to manufacturer’s product insert. Do not store solutions containing additives