Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-1043
Trade NameDose FormStrengthIdentifier
3% Citanest DENTAL with OctapressinSolution for injection.
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 injection, Formulation to 20-08-2014Active 
 Felypressin 0.03 IU/mL (0.46µg/ml.)PolyPeptide Laboratories AB
Hogerudsgaten 21
Limhamn SE-216 13
Sweden
 Prilocaine hydrochloride 3% (30mg/ml.)BASF Pharma (Evionnaz) SA
Route du Simplon 1, 36
Evionnaz CH-1902
Switzerland
 Excipient 
 Hydrochloric acid
 Sodium chloride
 Sodium hydroxide
 Water for injection
suspension for injection, Formulation from 20-08-2014Active 
 Felypressin 0.54 µg/mL
 Prilocaine hydrochloride 3% (30mg/ml.)
 Excipient 
 Hydrochloric acid
 Sodium chloride
 Sodium hydroxide
 Water for injection

Production

Manufacturing stepManufacturer
Manufacture of Final Dose FormPierrel S.p.A.
Strada Statale Appia 46/48
Capua
Italy
PackingPierrel 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, 100x1.8mL180 mL24 months from date of manufacture stored at or below 25°C protect from light
Cartridge, glass, Self aspirating 100x1.8mL180 mL24 months from date of manufacture stored at or below 25°C protect from light
Cartridge, glass, Aspirating, 100x2.2mL220 mL24 months from date of manufacture stored at or below 25°C protect from light
Cartridge, glass, 100x2.2mL220 mL24 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 DateApplication TypeChange(s)StatusPayment DatePriority
31/5/2019Self-Assessable Change NotificationData sheet - reformatting only (Self assessable)Notified17/6/2019 
19/2/2018CMN 24(5)Active ingredient manufacturing process - Grade 2; Active ingredient specifications/test methods - Grade 3; Finished product manufacturing process - Grade 1; Container/closure/packaging - Grade 1Additional evaluation started 18/06/201916/3/2018 
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