Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-2988/2 |
| Trade Name | Dose Form | Strength | Identifier |
| 5% Dextrose Injection USP (Biomed) | Solution for infusion | 5 % | |
| Sponsor | Application date | Registration situation | Classification |
| Biomed Limited P O Box 44069 Point Chevalier AUCKLAND | 1/5/1992 | Approval lapsed Approval date: 1/5/1992 Notification date: 2/8/2013 | General sale |
Composition
| Component | Ingredient | Manufacturer |
| solution for infusion | Active | |
| Glucose 5% | ||
| Excipient | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Manufacture of Final Dose Form | Kendall-McGaw Laboratories Inc. 2525 McGaw Avenue Irvine California 92714-5895 UNITED STATES OF AMERICA |
| Packing | Kendall-McGaw Laboratories Inc. 2525 McGaw Avenue Irvine California 92714-5895 UNITED STATES OF AMERICA |
| NZ Site of Product Release | Biomed Limited 52 Carrington Road Point Chevalier AUCKLAND |
Packaging
| Package | Contents | Shelf Life |
| Bag, plastic, | 25 mL | 12 months from date of manufacture stored at or below 25°C |
| Bag, plastic, | 50 mL | 15 months from date of manufacture stored at or below 25°C |
| Bag, plastic, | 100 mL | 15 months from date of manufacture stored at or below 25°C |
