Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
PROPOFOL
PFIZER CANADA ULC
N01AX10
PROPOFOL
10MG
EMULSION
PROPOFOL 10MG
INTRAVENOUS
20ML
Prescription
MISCELLANEOUS GENERAL ANESTHETICS
Active ingredient group (AIG) number: 0121833001; AHFS:
CANCELLED POST MARKET
2020-02-21
PRODUCT MONOGRAPH PR PROPOFOL INJECTION 1% w/v 10 mg/mL Pfizer Standard _Intravenous Emulsion - Anaesthetic - Sedative _ Pfizer Canada Inc. 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 DATE OF REVISION: October 2, 2018 Submission Control No.: 219681 _Product Monograph – _ _Pr_ _Propofol Injection_ _ _ _Page 2 of 45_ _ _ PRODUCT MONOGRAPH PR PROPOFOL INJECTION 1% w/v 10 mg/mL Pfizer Standard Intravenous Emulsion - Anaesthetic - Sedative ACTIONS AND CLINICAL PHARMACOLOGY Propofol is an intravenous hypnotic agent for use in the induction and maintenance of general anaesthesia or sedation. The drug, an alkylphenol formulated in an oil-in-water emulsion, is chemically distinct from currently available intravenous anaesthetic agents. Intravenous injection of a therapeutic dose of propofol produces hypnosis rapidly and smoothly, usually within 40 seconds from the start of an injection (one arm-brain circulation time), although induction times >60 seconds have been observed. PHARMACOKINETICS IN ADULTS The pharmacokinetic profile of propofol can be described by a 3-compartment open model. After a single bolus dose, there is fast distribution from blood into tissues (t ½ α: 1.8 to 8.3 min), high metabolic clearance (t ½ β : 34 to 66 min) and a terminal slow elimination from poorly perfused tissues (t ½ γ : 184-480 min). With 12 and 24 hour samplings, t ½ γ values of 502 and 674 min, respectively, were observed. Propofol has large volumes of distribution as would be expected with a highly lipophilic anaesthetic agent. The volume of central compartment (V c ) is between 21 and 56 L (0.35 - 0.93 L/kg based on a 60 kg patient), and the volume of distribution at steady state (V ss ) is between 171 and 364 L (2.85 - 6.07 L/kg). Values for volume of distribution during the terminal phase (V d ) are two to three times the corresponding V ss values. The termination of the anaesthetic or sedative effects of propofol after a single i.v. bolus or a maintenance infusion is due to extensive redistribution from the CNS Aqra d-dokument sħiħ