Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
---|---|---|
File ref: TT50-1043 |
Trade Name | Dose Form | Strength | Identifier |
3% Citanest DENTAL with Octapressin | Solution for injection | . | |
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, Formulation from 20-08-2014 | Active | |
Felypressin 0.54 µg/mL | PolyPeptide Laboratories AB Hogerudsgaten 21 Limhamn SE-216 13 SWEDEN | |
Prilocaine hydrochloride 3% (30mg/ml.) | Benechim S.R.L. Rue Rene Magritte 163 B-7860 Lessines BELGIUM | |
Siegfried Evionnaz SA Route du Simplon 1, 36 Evionnaz 1902 SWITZERLAND | ||
Excipient | ||
Hydrochloric acid | ||
Sodium chloride | ||
Sodium hydroxide | ||
Water for injection |
Production
Manufacturing step | Manufacturer |
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, 50x1.8mL | 90 mL | 24 months from date of manufacture stored at or below 25°C protect from light |
Cartridge, glass, Self aspirating 50x1.8mL | 90 mL | 24 months from date of manufacture stored at or below 25°C protect from light |
Cartridge, glass, Aspirating, 50x2.2mL | 110 mL | 24 months from date of manufacture stored at or below 25°C protect from light |
Cartridge, glass, 50x2.2mL | 110 mL | 24 months from date of manufacture stored at or below 25°C protect from light |
Cartridge, glass, 100x1.8mL | 180 mL | 24 months from date of manufacture stored at or below 25°C protect from light |
Cartridge, glass, Self aspirating 100x1.8mL | 180 mL | 24 months from date of manufacture stored at or below 25°C protect from light |
Cartridge, glass, Aspirating, 100x2.2mL | 220 mL | 24 months from date of manufacture stored at or below 25°C protect from light |
Cartridge, glass, 100x2.2mL | 220 mL | 24 months from date of manufacture stored at or below 25°C protect from light |
Indications
Infiltration anaesthesia in dentistry, where there is no need for profound ischaemia in the injected area.
Regional nerve block anaesthesia in dentistry.
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
26/7/2023 | Self-Assessable Change Notification | Labelling - G1 (Self assessable) | Notified | 8/8/2023 |