Extraneal

Extraneal Manufacturers

• Baxter Healthcare Corporation
  

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  Extraneal | Baxter Healthcare Corporation

  

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  2.1 Basic Dosing Information

  EXTRANEAL is intended for intraperitoneal administration only. Not for intravenous injection. Administer as a single daily exchange for the long dwell in continuous ambulatory peritoneal dialysis or automated peritoneal dialysis. The recommended dwell time is 8- to 16- hours. Administer over a period of 10-20 minutes at a rate that is comfortable for the patient.

  The mode of therapy, frequency of treatment, exchange volume, duration of dwell, and length of dialysis should be initiated and supervised by the prescribing physician experienced in the treatment of end-stage renal disease with peritoneal dialysis. It is recommended that patients being placed on peritoneal dialysis should be appropriately trained in a program that is under supervision of a physician.

  2.2 Directions for Use

  For complete CAPD and APD system preparation, see directions accompanying ancillary equipment.

  Aseptic technique should be used throughout the peritoneal dialysis procedure.

  For single use only.

  Storage

  Store in moisture barrier overwrap and in carton until ready to use [see How Supplied/Storage and Handling (16)].

  Warming

  For patient comfort, EXTRANEAL can be warmed to 37°C (98.6°F). Only dry heat should be used. It is best to warm solutions within the overwrap using a heating pad. Do not immerse EXTRANEAL in water for warming. Do not use a microwave oven to warm EXTRANEAL. Do not heat above 40°C (104°F).

  To Open

  To open, tear the overwrap down at the slit and remove the solution container. Some opacity of the plastic, due to moisture absorption during the sterilization process, may be observed. This does not affect the solution quality or safety and may often leave a slight amount of moisture within the overwrap.

  Inspect for Container Integrity and Solution Appearance

  Do not use EXTRANEAL if it is cloudy or discolored, if it contains particulate matter, or if the container is leaking.

  Inspect the patient connector to ensure the pull ring is attached. Do not use if pull ring is not attached to the connector. Inspect the EXTRANEAL container for signs of leakage and check for minute leaks by squeezing the container firmly. If the container has frangible(s), inspect that they are positioned correctly and are not broken. Do not use EXTRANEAL if the frangible(s) are broken or leaks are suspected as sterility may be impaired.

  For EXTRANEAL in UltraBag, inspect the tubing and drain container for presence of solution. Small droplets are acceptable, but if solution flows past the frangible prior to use, do not use and discard the units.

  Adding Medications

  The decision to add medication should be made by the physician after careful evaluation of the patient [see Drug Interactions (7), Clinical Pharmacology (12.3)].

  If the re-sealable rubber plug on the medication port is missing or partly removed, do not use the product if medication is to be added.

  To add a medication:

  • Put on mask. Clean and/or disinfect hands. • Prepare medication port site using aseptic technique. • Using a syringe with a 1-inch long, 25- to 19-gauge needle, puncture the medication port and inject additive. • Reposition container with container ports up and evacuate medication port by squeezing and tapping it. • Mix solution and additive thoroughly. Preparation for Administration • Put on mask. Clean and/or disinfect hands. • Place EXTRANEAL on work surface. • For ULTRABAG system for manual exchange, uncoil tubing and drain bag. Ensure the patient transfer set is closed. Break the connector (Y-set) frangible. • Remove pull ring from connector of solution container. If continuous fluid flow from connector is observed, discard solution container. Once the pull ring has been removed, do not reuse the solution or container. • Immediately attach the solution container to patient connector (transfer set) or appropriate peritoneal dialysis set. • For AMBU-FLEX II, continue with therapy set-up as instructed in user manual or directions accompanying tubing sets for automated peritoneal dialysis. • For ULTRABAG, follow the below steps: • Clamp solution line and then break frangible near solution bag. Hang solution container and place the drainage container below the level of the abdomen. • Open transfer set to drain the solution from abdomen. If drainage cannot be established, contact your clinician. When drainage complete, close transfer set. • Remove clamp from solution line and flush new solution to flow into the drainage container for 5 seconds to prime the line. Clamp drain line after flush complete. • Open transfer set to fill. When fill complete, close transfer set. • Disconnect ULTRABAG from transfer set and apply MINICAP.

  Completion of Therapy

  • Following use, the drained fluid should be inspected for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis. • Discard unused portion.

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