Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data Sheet
File ref: TT50-9241
Trade NameDose FormStrengthIdentifier
5% GlucoseSolution for infusion5 %Baxter
SponsorApplication dateRegistration situationClassification
Baxter Healthcare Ltd
P O Box 14062
Panmure
AUCKLAND 1741
13/3/2013Consent given
Approval date: 15/5/2014
General sale
 

Composition

ComponentIngredientManufacturer
solution for infusionActive 
 Glucose monohydrate 50 g/LIngredion Incorporated
6400 South Archer Avenue
Bedford Park
lll 60501
United States of America
 Excipient 
 Water for injection

Production

Manufacturing stepManufacturer
Finished Product TestingBaxter Healthcare Corporation
Highway 221 N
Marion
North Carolina 18752
United States of America
 Baxter Healthcare Corporation
Route 120 and Wilson Road
Round Lake
Illinois 60073
United States of America
Manufacture of Final Dose FormBaxter Healthcare Corporation
Highway 221 N
Marion
North Carolina 18752
United States of America
PackingBaxter Healthcare Corporation
Highway 221 N
Marion
North Carolina 18752
United States of America
Secondary PackagingBaxter Healthcare Pty Ltd
1 Baxter Drive
Old Toongabbie
NSW 2146
Australia
NZ Site of Product ReleaseBaxter Healthcare Ltd
33 Vestey Drive
Mt Wellington
AUCKLAND

Packaging

PackageContentsShelf Life
Bag, plastic, AVIVA (PL 2408-6) polyolefin plastic and over-pouch250 mL15 months from date of manufacture stored at or below 25°C
Bag, plastic, AVIVA (PL 2408-6) polyolefin plastic and over-pouch500 mL22 months from date of manufacture stored at or below 25°C
Bag, plastic, AVIVA (PL 2408-6) polyolefin plastic and over-pouch1000 mL24 months from date of manufacture stored at or below 25°C

Indications

Glucose (5%) Intravenous Infusions are mainly indicated:

Whenever non-electrolyte fluid replacement is required.
As a vehicle for drug delivery, provided that the added components are compatible with glucose.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
15/5/2017Self-Assessable Change NotificationFinished product specifications/test methods - Grade 3 (Self assessable); Data sheet - reformatting only (Self assessable)Notified31/5/2017 
13/3/2013New Intermediate-risk Medicine ApplicationNew intermediate-risk non-prescription medicineGranted 15/5/20144/4/2013 
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