Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-3711b |
| Trade Name | Dose Form | Strength | Identifier |
| Gastrolyte Electrolyte Hydration | Powder for oral solution | . | |
| Sponsor | Application date | Registration situation | Classification |
| sanofi-aventis new zealand limited P O Box 12851 Penrose AUCKLAND 1642 | 5/12/1989 | Approval lapsed Approval date: 5/4/1990 | General sale |
Composition
| Component | Ingredient | Manufacturer |
| powder for oral solution | Active | |
| Glucose monohydrate 3.56 g | TEREOS Starch & Sweeteners IBERIA SAU Avenida Salvador Allende 76-78 Zaragoza 50015 Spain | |
| Cargill SLU C/Marie Curie 6 Barcelona 08760 Spain | ||
| Tate & Lyle Tunnel Refinneries Aalst Belgium | ||
| Potassium chloride 0.3 g | K+S Minerals and Agriculture GmbH Plant Werra, Site Wintershall, In der Aue Heringen Werra 36266 Germany | |
| Klinge Chemicals Ltd 5 - 7 Albion Way Kelvin Industrial Estate East Kilbride Glasgow G750YN United Kingdom | ||
| Sodium acid citrate 0.53 g | Dr Paul Lohmann GmbH KG Hauptstrasse 2 Emmerthal 31860 Germany | |
| Sodium chloride 0.47 g | Dansk Salt A/S Hadsundvej 17 Mariager 9550 Denmark | |
| Sudwestdeutsche Salzwerke AG Saline Bad Friedrichshall Bergrat-Bilfinger-Strasse 3 Bad Friedreichshall 74177 Germany | ||
| Excipient | ||
| Hydrated silica | ||
| Orange flavour | ||
| Saccharin sodium |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | A Nattermann & Cie GmbH Nattermannallee 1 Koln 50829 Germany |
| Aspen Pharma Pty Ltd 96 Merrindale Drive Croydon VIC 3136 Australia | |
| Phytolab GmbH & Co. KG Dutendorferstr. 5-7 Vestenbergsgreuth 91487 Germany | |
| Manufacture of Final Dose Form | A Nattermann & Cie GmbH Nattermannallee 1 Koln 50829 Germany |
| Packing | A Nattermann & Cie GmbH Nattermannallee 1 Koln 50829 Germany |
| Secondary Packaging | Contract Pharmaceutical Services of Australia Pty Ltd 5 Eden Park Drive North Ryde NSW 2113 Australia |
| DHL Exel Supply Chain (Australia) Pty Ltd 16 Picrite Close Greystanes NSW 2145 Australia | |
| DHL Exel Supply Chain (Australia) Pty Ltd 227 Walters Road Arndell Park NSW 2148 Australia | |
| DHL Exel Supply Chain (Australia) Pty Ltd 52 Holbeche Rd Arndell Park NSW 2148 Australia | |
| DHL Exel Supply Chain (Australia) Pty Ltd 52 Huntingwood Drive Huntingwood New South Wales 2148 Australia | |
| Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 | |
| NZ Site of Product Release | No site specified |
Packaging
| Package | Contents | Shelf Life |
| Sachet, laminate, orange flavour, sample pack- 5g | 2 dose units | 36 months from date of manufacture stored at or below 25°C |
| Sachet, laminate, orange flavour,5g | 10 dose units | 36 months from date of manufacture stored at or below 25°C |
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 28/10/2020 | CMN 24(5) | Active ingredient specifications/test methods - Grade 3; Finished product packing site - Grade 2 | Withdrawn 4/10/2021 | 16/9/2021 |
