Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-1490/11
Trade NameDose FormStrengthIdentifier
0.5% Marcain Dental with Adrenaline 1:200,000Solution for injection.
SponsorApplication dateRegistration situationClassification
Dentsply Sirona (NZ) Limited
P O Box 5966
Auckland 1141
10/10/1991Approval lapsed
Approval date: 29/9/1992
Notification date: 30/10/2012
Prescription
 

Composition

ComponentIngredientManufacturer
Formulation to 06-05-2005, solution for injectionActive 
 Adrenaline acid tartrate 1:200000Boehringer 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 injectionActive 
 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 stepManufacturer
Secondary PackagingContract 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 ReleaseNot in New Zealand

Packaging

PackageContentsShelf Life
Cartridge, glass, (dental) 50 x 2.2ml50 dose units18 months from date of manufacture stored at or below 25°C
0 1 2 4 5 6 7 9 [ /