Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-1937/30
Trade NameDose FormStrengthIdentifier
2% Xylocaine DENTAL with Adrenaline (epinephrine) 1:80,000Solution for injectionDental cartridge
SponsorApplication dateRegistration situationClassification
Dentsply Sirona (NZ) Limited
P O Box 5966
Auckland 1141
31/12/1969Consent given
Approval date: 31/12/1969
Prescription
 

Composition

ComponentIngredientManufacturer
suspension for injectionActive 
 Adrenaline acid tartrate 0.0227 mg (= 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 21.3 mg (= 20 mg Lignocaine hydrochloride anhydrous)Moehs Catalana SL
Poligono 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 stepManufacturer
Finished Product TestingLaboratorios 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 FormLaboratorios 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
PackingLaboratorios 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 ReleaseAgility Logistics Ltd
9 Richard Pearse Drive
Mangere
Auckland

Packaging

PackageContentsShelf Life
Cartridge, glass, 2.2mL auto asp50 dose units24 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 std50 dose units24 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 asp100 dose units24 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 std100 dose units24 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 asp100 dose units24 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 std100 dose units24 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 DateApplication TypeChange(s)StatusPayment DatePriority
17/12/2018Changed Medicine NotificationActive ingredient manufacturing process - Grade 1; Data sheet - reformatting only; Labelling - Grade 1; Sponsor; Product nameGranted 26/3/201925/3/2019 
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