check for minute leaks by squeezing the container firmly.
Adding Medications
Some drug additives may be incompatible with EXTRANEAL. See DOSAGE AND ADMINISTRATION section for additional information. 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.
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.
Remove pull ring from connector of solution container. If continuous fluid flow from connector is observed, discard solution container.
Remove tip protector from tubing set and immediately attach to connector of solution container.
Continue with therapy set-up as instructed in user manual or directions accompanying tubing sets.
Upon completion of therapy, discard any unused portion.
HOW SUPPLIED
EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is available in the following containers and fill volumes:
Container Fill Volume NDC
ULTRABAG 1.5 L NDC 0941-0679-51
ULTRABAG 2.0 L NDC 0941-0679-52
ULTRABAG 2.5 L NDC 0941-0679-53
AMBU- FLEX III 1.5 L NDC 0941-0679-45
AMBU- FLEX III 2.0 L NDC 0941-0679-47
AMBU- FLEX III 2.5 L NDC 0941-0679-48
AMBU- FLEX II 2.0 L NDC 0941-0679-06
AMBU- FLEX II 2.5 L NDC 0941-0679-05
Each 100 mL of EXTRANEAL contains 7.5 grams of icodextrin in an electrolyte solution with 40 mEq/L lactate.
Store at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature]. Store in moisture barrier overwrap in carton until ready to use. Protect from freezing.
Rx Only
BAXTER, EXTRANEAL, ULTRABAG, and AMBU-FLEX are trademarks of Baxter International Inc.
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
Container Label
L5B4974
NDC 0941-0679-06
2000 mL
(APPROX 80 mL EXCESS)
Baxter
Extraneal (icodextrin)
Peritoneal Dialysis Solution
PD-2 7.5% icodextrin
EACH 100 mL CONTAINS 7.5 g ICODEXTRN 535 mg
SODIUM CHLORIDE USP 448 mg SODIUM LACTATE
25.7 mg CALCIUM CHLORIDE USP 5.08 mg MAGNESIUM
CHLORIDE USP WATER FOR INJECTION USP
mEq/L SODIUM 132 CALCIUM 3.5 MAGNESIUM 0.5
CHLORIDE 96 LACTATE 40
pH 5.0 - 6.0 pH MAY HAVE BEEN ADJUSTED WITH
HYDROCHLORIC ACID OR SODIUM HYDROXIDE
EXTRANEAL SOLUTION CONTAINS NO BACTERIOSTATIC OR
ANTIMICROBIAL AGENTS
OSMOLARITY (CALC) 282 - 286 mOsmol/L
STERILE NONPYROGENIC
POTASSIUM CHLORIDE TO BE ADDED ONLY UNDER
THE DIRECTION OF A PHYSICIAN
SEE PACKAGE INSERT FOR DOSAGE INFORMATION
USE AS DIRECTED BY A PHYSICIAN
FOR INTRAPERITONEAL ADMINISTRATION ONLY
CAUTIONS SQUEEZE AND INSPECT INNER BAG
THAT MAINTAINS PRODUCT STERILITY DISCARD IF
LEAKS ARE FOUND
DO NOT USE UNLESS SOLUTION IS CLEAR
DISCARD UNUSED PORTION
Rx ONLY
STORE IN MOISTURE BARRIER OVERPOUCH IN CARTON
UNTIL READY TO USE
STORE AT 20-25°C (68-77°F