Revised: 31 May 2019
Medicines
Medsafe Product Detail |  | |
|---|---|---|
| File ref: TT50-2184/18 |
| Trade Name | Dose Form | Strength | Identifier |
| Potassium Chloride 20mmol in 0.9% Sodium Chloride (1000mL) | Solution for infusion | (Baxter) | |
| Sponsor | Application date | Registration situation | Classification |
| Baxter Healthcare Ltd P O Box 14062 Panmure AUCKLAND 1741 | 29/9/1980 | Consent given Approval date: 29/9/1980 | General sale |
Composition
| Component | Ingredient | Manufacturer |
| solution for infusion | Active | |
| Potassium chloride 0.15%{relative} | ||
| Sodium chloride 0.9%{relative} | ||
| Excipient | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| 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 |
| 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
Indicated as a source of water and to restore electrolyte balance as required by the patient's clinical condition, such as hypokalaemia.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 7/7/2023 | Changed Medicine Notification | Finished product specifications/test methods - G2; Administrative fee (CMN) | Granted 8/9/2023 | 20/7/2023 |
