Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
---|---|---|
File ref: TT50-1937/30 |
Trade Name | Dose Form | Strength | Identifier |
2% Xylocaine DENTAL with Adrenaline (epinephrine) 1:80,000 | Solution for injection | Dental cartridge | |
Sponsor | Application date | Registration situation | Classification |
Dentsply Sirona (NZ) Limited P O Box 5966 Auckland 1141 | 31/12/1969 | Consent given Approval date: 31/12/1969 | Prescription |
Composition
Component | Ingredient | Manufacturer |
suspension for injection | Active | |
Adrenaline acid tartrate 0.0227mg equivalent to 12.5 µg adrenaline | Cambrex Profarmaco Milano Srl Via Curiel 34 Paullo Milano 20067 ITALY | |
Boehringer Ingelheim Pharma GmbH & Co KG Binger Strasse 173 Ingelheim am Rhein 55216 GERMANY | ||
Lidocaine hydrochloride monohydrate 21.3mg equivalent to 20 mg Lignocaine hydrochloride anhydrous | Moehs Catalana SL Poligono Industrial Rubi Sur Cesar Martinell I Brunet 12A Rubi Barcelona 08191 SPAIN | |
Excipient | ||
Hydrochloric acid | ||
Sodium chloride | ||
Sodium hydroxide | ||
Sodium metabisulfite | ||
Water for injection |
Production
Manufacturing step | Manufacturer |
Finished Product Testing | Laboratorios INIBSA, S.A. Ctra. Sabadell a Granollers, km 14,5 Llica de Vall 08185 Barcelona SPAIN |
Pierrel S.p.A. Strada Statale Appia 46/48 Capua ITALY | |
Manufacture of Final Dose Form | Laboratorios INIBSA, S.A. Ctra. Sabadell a Granollers, km 14,5 Llica de Vall 08185 Barcelona SPAIN |
Pierrel S.p.A. Strada Statale Appia 46/48 Capua ITALY | |
Packing | Laboratorios INIBSA, S.A. Ctra. Sabadell a Granollers, km 14,5 Llica de Vall 08185 Barcelona SPAIN |
Pierrel S.p.A. Strada Statale Appia 46/48 Capua ITALY | |
NZ Site of Product Release | Agility Logistics Ltd 9 Richard Pearse Drive Mangere Auckland |
Packaging
Package | Contents | Shelf Life |
Cartridge, glass, 2.2mL auto asp | 50 dose units | 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Once removed from refrigeration, store below 25°C & use within 4 weeks. Do not re-refrigerate |
Cartridge, glass, 2.2mL std | 50 dose units | 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Once removed from refrigeration, store below 25°C & use within 4 weeks. Do not re-refrigerate |
Cartridge, glass, 2.2mL auto asp | 100 dose units | 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Once removed from refrigeration, store below 25°C & use within 4 weeks. Do not re-refrigerate |
Cartridge, glass, 2.2mL std | 100 dose units | 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Once removed from refrigeration, store below 25°C & use within 4 weeks. Do not re-refrigerate |
Cartridge, glass, 1.8mL auto asp | 100 dose units | 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Once removed from refrigeration, store below 25°C & use within 4 weeks. Do not re-refrigerate |
Cartridge, glass, 1.8mL std | 100 dose units | 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Once removed from refrigeration, store below 25°C & use within 4 weeks. Do not re-refrigerate |
Indications
The product is indicated for the production of local nerve anaesthesia in routine dental procedures and oral surgery by means of infiltration and nerve block techniques. Lidocaine solutions with adrenaline are recommended for oral surgery requiring prolonged duration of anaesthesia and haemostasis.
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
15/6/2021 | Changed Medicine Notification | Container/closure/packaging - Grade 2 | Granted 7/9/2021 | 23/6/2021 |