Revised: 31 May 2019
Medicines
Medsafe Product Detail |  | |
|---|---|---|
| File ref: TT50-9241 |
| Trade Name | Dose Form | Strength | Identifier |
| 5% Glucose | Solution for infusion | 5 % | Baxter |
| Sponsor | Application date | Registration situation | Classification |
| Baxter Healthcare Ltd P O Box 14062 Panmure AUCKLAND 1741 | 13/3/2013 | Not available Approval date: 15/5/2014 Notification date: 20/11/2020 | General sale |
Composition
| Component | Ingredient | Manufacturer |
| solution for infusion | Active | |
| Glucose monohydrate 50 g/L | Ingredion Incorporated 6400 South Archer Avenue Bedford Park lll 60501 UNITED STATES OF AMERICA | |
| Excipient | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Baxter Healthcare Corporation Highway 221 N Marion North Carolina 18752 UNITED STATES OF AMERICA |
| Baxter Healthcare Corporation Route 120 and Wilson Road Round Lake Illinois 60073 UNITED STATES OF AMERICA | |
| Manufacture of Final Dose Form | Baxter Healthcare Corporation Highway 221 N Marion North Carolina 18752 UNITED STATES OF AMERICA |
| Packing | Baxter Healthcare Corporation Highway 221 N Marion North Carolina 18752 UNITED STATES OF AMERICA |
| Secondary Packaging | Baxter Healthcare Pty Ltd 1 Baxter Drive Old Toongabbie NSW 2146 AUSTRALIA |
| NZ Site of Product Release | Baxter Healthcare Ltd 33 Vestey Drive Mt Wellington AUCKLAND |
Packaging
| Package | Contents | Shelf Life |
| Bag, plastic, AVIVA (PL 2408-6) polyolefin plastic and over-pouch | 250 mL | 15 months from date of manufacture stored at or below 25°C |
| Bag, plastic, AVIVA (PL 2408-6) polyolefin plastic and over-pouch | 500 mL | 22 months from date of manufacture stored at or below 25°C |
| Bag, plastic, AVIVA (PL 2408-6) polyolefin plastic and over-pouch | 1000 mL | 24 months from date of manufacture stored at or below 25°C |
Indications
Glucose (5%) Intravenous Infusions are mainly indicated:
Whenever non-electrolyte fluid 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 |
| 15/5/2017 | Self-Assessable Change Notification | Finished product specifications/test methods - Grade 3 (Self assessable); Data sheet - reformatting only (Self assessable) | Notified | 31/5/2017 | |
| 13/3/2013 | New Intermediate-risk Medicine Application | New intermediate-risk non-prescription medicine | Granted 15/5/2014 | 4/4/2013 |
