Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data Sheet
File ref: TT50-9242
Trade NameDose FormStrengthIdentifier
0.9% Sodium ChlorideSolution for infusion0.9 %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 
 Sodium chloride 9 g/LEsco 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, VIAFLO (PL 2442) polyethylene plastic bag250 mL24 months from date of manufacture stored at or below 25°C
Bag, plastic, VIAFLO (PL 2442) polyethylene plastic bag500 mL24 months from date of manufacture stored at or below 25°C
Bag, plastic, VIAFLO (PL 2442) polyethylene plastic bag1000 mL24 months from date of manufacture stored at or below 25°C

Indications

As a vehicle 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 and chloride ions.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
21/8/2019Self-Assessable Change NotificationData sheet - miscellaneous changes (Self assessable)Notified30/8/2019 
13/3/2013New Intermediate-risk Medicine ApplicationNew intermediate-risk non-prescription medicineGranted 15/5/20144/4/2013 
0 1 2 4 5 6 7 9 [ /