PROPOFOL EMULSION

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

PROPOFOL

Доступно од:

BAXTER CORPORATION

АТЦ код:

N01AX10

INN (Међународно име):

PROPOFOL

Дозирање:

10MG

Фармацеутски облик:

EMULSION

Састав:

PROPOFOL 10MG

Пут администрације:

INTRAVENOUS

Јединице у пакету:

20ML/50ML/100ML

Тип рецептора:

Prescription

Терапеутска област:

MISCELLANEOUS GENERAL ANESTHETICS

Резиме производа:

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

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2024-01-30

Карактеристике производа

_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
..................