Revised: 31 May 2019
Medicines
Medsafe Product Detail |  | |
|---|---|---|
| File ref: TT50-10414 |
| Trade Name | Dose Form | Strength | Identifier |
| 5% Glucose | Solution for infusion | 5% 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: 20/12/2018 | General sale |
| Reference product: Glucose Injection (Baxter) Solution for infusion 5 % | |||
Composition
| Component | Ingredient | Manufacturer |
| solution for infusion | Active | |
| Glucose monohydrate 5.5%{relative} equivalent to 5%w/v Glucose | Roquette Freres 1 Rue de la Haute Loge Lestrem 62136 FRANCE | |
| Cargill SLU C/Marie Curie 6 Barcelona 08760 SPAIN | ||
| 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 |
| Secondary Packaging | Baxter Healthcare Ltd 33 Vestey Drive Mt Wellington AUCKLAND |
| 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 | 50 mL | 17 months from date of manufacture stored at or below 25°C |
| Bag, plastic, VIAFLO (PL 2442) polyethylene plastic bag | 100 mL | 24 months from date of manufacture stored at or below 25°C |
| Bag, plastic, VIAFLO (PL 2442) polyethylene plastic bag | 250 mL | 18 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 | 18 months from date of manufacture stored at or below 25°C |
Indications
Whenever non-electrolyte infusion replacement is required
As a vehicle for drug delivery, provided that the added components are compatible with glucose
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 20/12/2018 | 6/6/2018 |
