PROPOFOL EMULSION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

PROPOFOL

Saadav alates:

BAXTER CORPORATION

ATC kood:

N01AX10

INN (Rahvusvaheline Nimetus):

PROPOFOL

Annus:

10MG

Ravimvorm:

EMULSION

Koostis:

PROPOFOL 10MG

Manustamisviis:

INTRAVENOUS

Ühikuid pakis:

20ML/50ML/100ML

Retsepti tüüp:

Prescription

Terapeutiline ala:

MISCELLANEOUS GENERAL ANESTHETICS

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2024-01-30

Toote omadused

_PROPOFOL Product Monograph _
_Page 1 of 48_
_ _
PRODUCT MONOGRAPH
PR
PROPOFOL
Propofol Injectable Emulsion, BP
1% w/v
10 mg/mL
Intravenous Emulsion – Anaesthetic - Sedative
Baxter Corporation
7125 Mississauga Road
Mississauga, Ontario
L5N 0C2
Date of Revision:
September 29, 2017
Submission Control No: 207653
_PROPOFOL Product Monograph _
_Page 2 of 48_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
................................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
DETAILED PHARMACOLOGY
.....................................................................................27
TOXICOLOGY
..................