Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data Sheet
File ref: TT50-10414
Trade NameDose FormStrengthIdentifier
5% GlucoseSolution for infusion5% w/vViaflo
SponsorApplication dateRegistration situationClassification
Baxter Healthcare Ltd
P O Box 14062
Panmure
AUCKLAND 1741
7/5/2018Consent given
Approval date: 20/12/2018
General sale
Reference product: Glucose Injection (Baxter) Solution for infusion 5 %

Composition

ComponentIngredientManufacturer
solution for infusionActive 
 Glucose monohydrate 5% w/vRoquette Freres
Rue de la Haute Loge
Lestrem 62136
France
  Ingredion Incorporated
6400 South Archer Avenue
Bedford Park
lll 60501
United States of America
 Excipient 
 Water for injection

Production

Manufacturing stepManufacturer
Finished Product TestingBaxter Healthcare Pty Ltd
1 Baxter Drive
Old Toongabbie
NSW 2146
Australia
Manufacture of Final Dose FormBaxter Healthcare Pty Ltd
1 Baxter Drive
Old Toongabbie
NSW 2146
Australia
PackingBaxter 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, viaflex (PVC)50 mL24 months from date of manufacture stored at or below 30°C
Bag, plastic, viaflex (PVC)100 mL24 months from date of manufacture stored at or below 30°C
Bag, plastic, viaflex (PVC)250 mL24 months from date of manufacture stored at or below 30°C
Bag, plastic, viaflex (PVC)500 mL24 months from date of manufacture stored at or below 30°C
Bag, plastic, viaflex (PVC)1000 mL24 months from date of manufacture stored at or below 30°C

Indications

Whenever non-electrolyte infusion 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
25/1/2019CMN 24(5)Active ingredient manufacturing site; Finished product packing site - Grade 1; Finished product manufacturing process - Grade 1; Container/closure/packaging - Grade 4; Data sheet - miscellaneous changes; Labelling - Grade 1Initial evaluation15/2/2019 
7/5/2018New Lower-risk Medicine ApplicationAdditional name - Grade 2Granted 20/12/20186/6/2018 
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