PRILOTEKAL prilocaine hydrochloride 100 mg/5 mL solution for injection ampoule, B Braun Australia Pty Ltd, CON-1114
Product name
PRILOTEKAL prilocaine hydrochloride 100 mg/5 mL solution for injection ampoule
Sponsor name
B Braun Australia Pty Ltd
Batches
All relevant batches of the product released from the 16 March 2023 until 16 March 2028
Consent start
Consent no.
CON-1114
Standard
The product does not conform with the requirements of official standards, either Prilocaine Injection (British Pharmacopoeia 2023) or Prilocaine Hydrochloride Injection (United States Pharmacopeia 2023). of United States Pharmacopoeia
Non-compliance with standard
The product does not necessarily conform because: ' It has a pH in the range 4.0
'“ 6.0. ' The Prilocaine Injection (British Pharmacopoeia 2023) monograph
requires Acidity: pH 5.0 to 7.0; ' The Prilocaine Hydrochloride Injection
(United States Pharmacopeia 2023) monograph requires pH Œ©791Œª: 6.0'“7.0.
Conditions imposed
The pH of the injection is in the range 4.0 '“ 6.0.
Therapeutic product type
Prescription medicines