FDA Label for Extraneal
View Indications, Usage & Precautions
Extraneal Product Label
The following document was submitted to the FDA by the labeler of this product Vantive Us Healthcare Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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