y elevated glucose readings. For a list of toll free numbers for glucose monitor and test strip
manufacturers, please contact the Baxter Renal Clinical Help Line 1-888-RENAL-HELP or visitwww.glucosesafety.com.
Because of the risk of unrecognized hypoglycemia that could result from a drug-device interaction, EXTRANEAL is
available only through a restricted program (5.2)
1. INDICATIONS AND USAGE
EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell duringcontinuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management ofend-stage renal disease. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell
ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transportcharacteristics, as defined using the peritoneal equilibration test (PET) [see Clinical Pharmacology (12), Clinical
Studies (14)].
2. DOSAGE AND ADMINISTRATION
2.1 Basic Dosing Information
EXTRANEAL is intended for intraperitoneal administration only. Not for intravenous injection. Administer as asingle daily exchange for the long dwell in continuous ambulatory peritoneal dialysis or automated peritonealdialysis. The recommended dwell time is 8- to 16- hours. Administer over a period of 10-20 minutes at a rate that iscomfortable for the patient.
The mode of therapy, frequency of treatment, exchange volume, duration of dwell, and length of dialysis should beinitiated and supervised by the prescribing physician experienced in the treatment of end-stage renal disease withperitoneal dialysis. It is recommended that patients being placed on peritoneal dialysis should be appropriatelytrained 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-dose 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 (e.g., heatingpad, warming plate). 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 tomoisture absorption during the sterilization process, may be observed. This does not affect the solution quality orsafety 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 theconnector. Inspect the EXTRANEAL container for signs of leakage and check for minute leaks by squeezing thecontainer firmly. If the container has frangible(s), inspect that they are positioned correctly and are not broken.
Donot 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. Sma |
