Revised: 31 May 2019
Medicines
Medsafe Product Detail |  | |
|---|---|---|
| File ref: TT50-1433/2 |
| Trade Name | Dose Form | Strength | Identifier |
| Glucose 5% Sodium Chloride 0.45% | Solution for infusion | (Baxter) | |
| Sponsor | Application date | Registration situation | Classification |
| Baxter Healthcare Ltd P O Box 14062 Panmure AUCKLAND 1741 | 17/5/1991 | Consent given Approval date: 17/5/1991 | General sale |
Composition
| Component | Ingredient | Manufacturer |
| solution for infusion | Active | |
| Glucose 5% | ||
| Sodium chloride 0.45% | ||
| Excipient | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Baxter Healthcare Pty Ltd 1 Baxter Drive Old Toongabbie NSW 2146 AUSTRALIA |
| Manufacture of Final Dose Form | Baxter Healthcare Pty Ltd 1 Baxter Drive Old Toongabbie NSW 2146 AUSTRALIA |
| Packing | Baxter Healthcare Pty Ltd 1 Baxter Drive Old Toongabbie NSW 2146 AUSTRALIA |
| 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, Viaflex | 1000 mL | 24 months from date of manufacture stored at or below 30°C |
Indications
Glucose and sodium chloride infusion solution is indicated for replenishing fluid losses, as an energy source and for restoration or maintenance of sodium and chloride ion concentrations. It may be used as a vehicle of medication delivery where intravenous delivery is appropriate and the medicine is compatible with this solution.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 4/7/2023 | Changed Medicine Notification | Finished product specifications/test methods - G2; Administrative fee (CMN) | Granted 31/8/2023 | 20/7/2023 |
