Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-1490/11 |
| Trade Name | Dose Form | Strength | Identifier |
| 0.5% Marcain Dental with Adrenaline 1:200,000 | Solution for injection | . | |
| Sponsor | Application date | Registration situation | Classification |
| Dentsply Sirona (NZ) Limited P O Box 5966 Auckland 1141 | 10/10/1991 | Approval lapsed Approval date: 29/9/1992 Notification date: 30/10/2012 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| Formulation to 06-05-2005, solution for injection | Active | |
| Adrenaline acid tartrate 1:200000 | Boehringer Ingelheim Pharma GmbH & Co KG Binger Strasse 173 Ingelheim am Rhein 55216 GERMANY | |
| Bupivacaine hydrochloride monohydrate 0.528% equivalent to bupivacaine hydrochloride anydrous 5 mg/mL | BASF Pharma (Evionnaz) SA Route Cantonale Evionnaz CH-1902 SWITZERLAND | |
| Cambrex Karlskoga AB Pharma Chemicals Division Bjorkborn Omrade Karlskoga SE-691 85 SWEDEN | ||
| Excipient | ||
| Hydrochloric acid | ||
| Sodium chloride | ||
| Sodium metabisulfite | ||
| Water for injection | ||
| Formulation from 6-05-2005, solution for injection | Active | |
| Adrenaline acid tartrate 1:200000 | ||
| Bupivacaine hydrochloride monohydrate 0.528% equivalent to bupivacaine hydrochloride anydrous 5mg/mL | ||
| Excipient | ||
| Hydrochloric acid | ||
| Sodium chloride | ||
| Sodium hydroxide | ||
| Sodium metabisulfite | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Secondary Packaging | Contract Pharmaceutical Services of Australia Pty Ltd 44 - 48 Waterloo Rd (No longer operational 28.4.06 North Ryde NSW 2113 AUSTRALIA |
| NZ Site of Product Release | Not in New Zealand |
Packaging
| Package | Contents | Shelf Life |
| Cartridge, glass, (dental) 50 x 2.2ml | 50 dose units | 18 months from date of manufacture stored at or below 25°C |
