Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data Sheet
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/vEsco France SAS
Saline de Dombasle
1 rue de la saline
Dombasle 54110
France
 Excipient 
 Water for injection

Production

Manufacturing stepManufacturer
Finished Product TestingBieffe Medital SA
Ctra de Biescas - Senegue
Sabinanigo (Huesca) 22666
Spain
Manufacture of Final Dose FormBieffe Medital SA
Ctra de Biescas - Senegue
Sabinanigo (Huesca) 22666
Spain
PackingBieffe Medital SA
Ctra de Biescas - Senegue
Sabinanigo (Huesca) 22666
Spain
NZ Site of Product ReleaseBaxter Healthcare Ltd
33 Vestey Drive
Mt Wellington
AUCKLAND

Packaging

PackageContentsShelf Life
Bag, plastic, Viaflo50 mL15 months from date of manufacture stored at or below 25°C
Bag, plastic, Viaflo100 mL18 months from date of manufacture stored at or below 25°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
28/8/2019CMN 24(5)Active ingredient manufacturing site; Finished product manufacturing process - Grade 2; Container/closure/packaging - Grade 4; Data sheet - miscellaneous changesGranted 21/5/20204/9/2019 
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 [ /