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PRILOTEKAL prilocaine hydrochloride 100 mg/5 mL solution for injection ampoule, B Braun Australia Pty Ltd , CON-1083
Product name
PRILOTEKAL prilocaine hydrochloride 100 mg/5 mL solution for injection ampoule
Sponsor name
B Braun Australia Pty Ltd
Consent start
Consent no.
CON-1083
Standard
pH requirements of Prilocaine Injection (British Pharmacopoeia 2023) or Prilocaine Hydrochloride Injection (United States Pharmacopeia 2023). of British 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.
Therapeutic product type
Prescription medicines