EXTRANEAL- icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution

EXTRANEAL by

Drug Labeling and Warnings

EXTRANEAL by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation, Baxter Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Health Care Provider Letter

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

JB9923L 2500 mL DIN 02240806

2D barcode
(01)00085412150116

Extraneal 7.5% Icodextrin Peritoneal
Dialysis Solution

FOR INTRAPERITONEAL ADMINISTRATION
APPROX 90 mL EXCESS / EXCES APPROX DE 90 mL
NONPYROGENIC / STERILE / APYROGENE
APPROX pH 5.2

PER/PAR 1000 mL
ICODEXTRIN / ICODEXTRINE – 75 g
SODIUM CHLORIDE / CHLORURE DE SODIUM USP – 5.35 g
SODIUM LACTATE / LACTATE DE SODIUM – 4.48 g
CALCIUM CHLORIDE DIHYDRATE / DIHYRATE DE CHLORURE DE CALCIUM USP -
257 mg
MAGNESIUM CHLORIDE HEXAHYDRATE / HEXAHYDRATE DE CHLORURE DE
MAGNESIUM USP – 51 mg
IN WATER FOR INJECTIONS / DANS DE L’EAU POUR INJECTION USP
THEORETICAL OSMOLARITY 284 mOsmol/L /
OSMOLARITE THEORIQUE 284 mOsmol/L

APPROX mmol/L Na – 132 Ca – 1.75 Mg – 0.25 Cl – 96 LACTATE – 40

NOT TO BE USED FOR INTRAVENOUS INFUSION
FOR DOSAGE ADMINISTRATION AND DETAILED DIRECTIONS FOR USE SEE
PACKAGE INSERT / PRODUCT MONOGRAPH AVAILABLE UPON REQUEST /
DO NOT USE UNLESS SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED
/ DISCARD UNUSED PORTION / STORE AT 15°C TO 25°C / DO NOT FREEZE /
KEEP OUT OF REACH OF CHILDREN

Extraneal Solution d’Icodextrine à 7,5 % pour
Dialyse Péritonéale

POUR ADMINISTRATION PAR VOIE INTRAPERITONEALE

NE PAS ADMINSTRER PAR PERFUSION INTRAEINEUSE / CONSULTER LA
NOTICE D’EMBALLAGE POUR CONNAITRE LES RENSEIGNEMENTS SUR LA
POSOLOGIE L’ADMINISTRATION ET LE MODE D’EMPLOI MONOGRAPHIE DU
PRODUIT DISPONIBLE SUR DEMANDE / NE PAS EMPLOYER SI LA SOLUTION
EST TROUBLE OU SI LE SAC EST ENDOMMAGE / JETER TOUTE PORTION
INUTILISEE / GARDER ENTRE 15 °C / PROTEGER DU GEL / GARDER
HORS DE LA PORTEE DES ENFANTS

PVC CONTAINER / CONTENANT DE PVC

BAXTER AND EXTRANEAL ARE TRADEMARKS OF BAXTER INTERNATIONAL INC
BAXTER ET EXTRANEAL SONT DES MARQUES DE COMMERCE DE BAXTER INTERNATIONAL INC

BaxterLogo
Baxter Corporation
Mississauga ON L5N 0C2

Non Latex Symbol
88-70-20-372

500 500

250 250

Store at/Garder entre 15° C to/et 25° C
5-2500 mL IN/DANS 3000 mL

JB-99-23LP ICODEXTRIN 7.5% ICODEXTRINE

EXTRANEAL™ PD SOLUTION
SOLUTION POR DP

LOT: WWWWWWWWW EXP: 2099 99

2d Barcode
(01)50085412150111

INGREDIENTS AND APPEARANCE

EXTRANEAL 
icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0941-0709
Route of Administration	INTRAPERITONEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ICODEXTRIN (UNII: 2NX48Z0A9G) (ICODEXTRIN - UNII:2NX48Z0A9G)	ICODEXTRIN	75 g  in 1000 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	5.35 g  in 1000 mL
SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT)	SODIUM LACTATE	4.48 g  in 1000 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)	CALCIUM CHLORIDE	257 mg  in 1000 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)	MAGNESIUM CHLORIDE	51 mg  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0941-0709-05	5 in 1 CARTON	11/10/2024
1	NDC: 0941-0709-01	2500 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		11/10/2024

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Corporation		205087968	analysis(0941-0709) , label(0941-0709) , manufacture(0941-0709) , sterilize(0941-0709) , pack(0941-0709)