Revised: 31 May 2019
Medicines
Medsafe Product Detail |  | |
|---|---|---|
| File ref: TT50-10413 |
| Trade Name | Dose Form | Strength | Identifier |
| 0.9% Sodium Chloride | Solution for infusion | 0.9% w/v | Viaflo |
| Sponsor | Application date | Registration situation | Classification |
| Baxter Healthcare Ltd P O Box 14062 Panmure AUCKLAND 1741 | 7/5/2018 | Consent given Approval date: 31/1/2019 | General sale |
| Reference product: Sodium Chloride Solution for infusion 0.9 % (Baxter) | |||
Composition
| Component | Ingredient | Manufacturer |
| solution for infusion | Active | |
| Sodium chloride 0.9%{relative} | 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 | 50 mL | 15 months from date of manufacture stored at or below 25°C |
| Bag, plastic, Viaflo | 100 mL | 18 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 Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 13/12/2023 | Changed Medicine Notification | Finished product manufacture - G1; Administrative fee (CMN) | Granted 19/1/2024 | 27/12/2023 | |
| 7/5/2018 | New Lower-risk Medicine Application | Additional name - Grade 2 | Granted 31/1/2019 | 6/6/2018 |
