Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-10413
Trade NameDose FormStrengthIdentifier
0.9% Sodium ChlorideSolution for infusion0.9% w/vViaflo
SponsorApplication dateRegistration situationClassification
Baxter Healthcare Ltd
P O Box 14062
Panmure
AUCKLAND 1741
7/5/2018Consent given
Approval date: 31/1/2019
General sale
Reference product: Sodium Chloride Solution for infusion 0.9 % (Baxter)

Composition

ComponentIngredientManufacturer
solution for infusionActive 
 Sodium chloride 0.9% w/vDominion Salt Ltd
89 Totara Street
Mount Maunganui
  US Salt
Salt Point Road
Watkins Glen
NY 14891
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, viaflex50 mL18 months from date of manufacture stored at or below 30°C
Bag, plastic, viaflex100 mL18 months from date of manufacture stored at or below 30°C

Indications

- As a vehichle for the administration of parenteral drugs
- Also utilised as an extracellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium chloride ions

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
28/8/2019Changed Medicine NotificationActive ingredient manufacturing site; Finished product manufacturing process - Grade 2; Container/closure/packaging - Grade 4Additional evaluation started 23/10/20194/9/2019 
7/5/2018New Lower-risk Medicine ApplicationAdditional name - Grade 2Granted 31/1/20196/6/2018 
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /