Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-8818 |
| Trade Name | Dose Form | Strength | Identifier |
| Magnesium Sulfate Injection | Solution for injection | 50% w/v | Martindale |
| Sponsor | Application date | Registration situation | Classification |
| Max Health Limited P O Box 44452 Pt Chevalier Auckland 1246 | 6/5/2011 | Consent given Approval date: 7/6/2012 Notification date: 18/7/2017 Labelling exemption expires 22/02/2026 | General sale |
Composition
| Component | Ingredient | Manufacturer |
| solution for injection | Active | |
| Magnesium sulfate heptahydrate 50%{relative} | Macco Organiques sro Zahradni 1938/46c Bruntal 79201 CZECH REPUBLIC | |
| Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 GERMANY | ||
| Excipient | ||
| Hydrochloric acid | ||
| Sodium hydroxide | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | ALS Mikrolab Stockholm AB Kung Hans Väg 3 Sollentuna 19268 SWEDEN |
| Helvic Limited Unit E4, Trentham Business Quarter Bellriger Road Trentham Stoke-on-Trent ST4 8GB UNITED KINGDOM | |
| Macarthys Pharmaceuticals T/A Martindale Pharma Bampton Road Harold Hill Romford Essex RM3 8UG UNITED KINGDOM | |
| Reading Scientific Services Limited 2-3 Millars Business Centre Fishponds Close Wokingham RG41 2TZ UNITED KINGDOM | |
| Manufacture of Final Dose Form | Macarthys Pharmaceuticals T/A Martindale Pharma Bampton Road Harold Hill Romford Essex RM3 8UG UNITED KINGDOM |
| Overlabelling | DHL Supply Chain (New Zealand) Ltd Cnr George Bolt Memorial Drive & Manu Tapu Drive Mangere AUCKLAND |
| Packing | Macarthys Pharmaceuticals T/A Martindale Pharma Bampton Road Harold Hill Romford Essex RM3 8UG UNITED KINGDOM |
| NZ Site of Product Release | Max Health Limited Office 3 Health Support Ltd 2 Segar Ave, Pt Chev Auckland |
Packaging
| Package | Contents | Shelf Life |
| Ampoule, glass, Clear Type I Neutral 10 mL | 10 dose units | 36 months from date of manufacture stored at or below 25°C |
| Ampoule, glass, Clear Type I Neutral 5 mL | 10 dose units | 36 months from date of manufacture stored at or below 25°C |
| Ampoule, glass, Clear Type I Neutral 2 mL | 10 dose units | 36 months from date of manufacture stored at or below 25°C |
Indications
Mineral supplement indicated in the treatment of magnesium deficiency in hypomagnesaemia and to prevent further seizures associated with eclampsia.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 28/11/2023 | Changed Medicine Notification | Labelling - G3 | Granted 21/12/2023 | 30/11/2023 | |
| 6/5/2011 | New Intermediate-risk Medicine Application | New intermediate-risk non-prescription medicine | Granted 7/6/2012 | 6/5/2011 |
