Revised: 31 May 2019
Medicines
Medsafe Product Detail |  | |
|---|---|---|
| File ref: TT50-9242 |
| Trade Name | Dose Form | Strength | Identifier |
| 0.9% Sodium Chloride | Solution for infusion | 0.9 % | Baxter |
| Sponsor | Application date | Registration situation | Classification |
| Baxter Healthcare Ltd P O Box 14062 Panmure AUCKLAND 1741 | 13/3/2013 | Consent given Approval date: 15/5/2014 | General sale |
Composition
| Component | Ingredient | Manufacturer |
| solution for infusion | Active | |
| Sodium chloride 9 g/L | K+S France SAS ZA Solvay Porte Est Route des Digues Dombasle-sur-Meurthe 54110 FRANCE | |
| Excipient | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Bieffe Medital SA Ctra de Biescas - Senegue Sabinanigo (Huesca) 22666 SPAIN |
| Manufacture of Final Dose Form | Bieffe Medital SA Ctra de Biescas - Senegue Sabinanigo (Huesca) 22666 SPAIN |
| Packing | Bieffe Medital SA Ctra de Biescas - Senegue Sabinanigo (Huesca) 22666 SPAIN |
| NZ Site of Product Release | Baxter Healthcare Ltd 33 Vestey Drive Mt Wellington AUCKLAND |
Packaging
| Package | Contents | Shelf Life |
| Bag, plastic, VIAFLO (PL 2442) polyethylene plastic bag | 250 mL | 24 months from date of manufacture stored at or below 25°C |
| Bag, plastic, VIAFLO (PL 2442) polyethylene plastic bag | 500 mL | 24 months from date of manufacture stored at or below 25°C |
| Bag, plastic, VIAFLO (PL 2442) polyethylene plastic bag | 1000 mL | 24 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 Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 15/4/2021 | Changed Medicine Notification | Finished product manufacturing process - Grade 1; Administrative fee (CMN) | Granted 25/5/2021 | 29/4/2021 | |
| 13/3/2013 | New Intermediate-risk Medicine Application | New intermediate-risk non-prescription medicine | Granted 15/5/2014 | 4/4/2013 |
