PROPOFOL INJECTION EMULSION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

PROPOFOL

Tilgængelig fra:

PFIZER CANADA ULC

ATC-kode:

N01AX10

INN (International Name):

PROPOFOL

Dosering:

10MG

Lægemiddelform:

EMULSION

Sammensætning:

PROPOFOL 10MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

20ML

Recept type:

Prescription

Terapeutisk område:

MISCELLANEOUS GENERAL ANESTHETICS

Produkt oversigt:

Active ingredient group (AIG) number: 0121833001; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2020-02-21

Produktets egenskaber

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