PROPOFOL-II INJECTION EMULSION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

PROPOFOL

Доступна з:

PFIZER CANADA ULC

Код атс:

N01AX10

ІПН (Міжнародна Ім'я):

PROPOFOL

Дозування:

10MG

Фармацевтична форма:

EMULSION

Склад:

PROPOFOL 10MG

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

20ML

Тип рецепту:

Prescription

Терапевтична области:

MISCELLANEOUS GENERAL ANESTHETICS

Огляд продуктів:

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

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2020-02-24

Характеристики продукта

_Product Monograph – _
_Pr_
_Propofol-II Injection _
_ _
_Page 1 of 54_
_ _
PRODUCT MONOGRAPH
PR
PROPOFOL-II INJECTION 1% w/v
propofol injection
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.: 219498
_Product Monograph – _
_Pr_
_Propofol-II Injection _
_ _
_Page 2 of 54_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
......................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
.................................................................................................
4
WARNINGS AND PRECAUTIONS
...............................................................................
5
ADVERSE REACTIONS
...............................................................................................
10
DRUG INTERACTIONS
...............................................................................................
15
DOSAGE AND ADMINISTRATION
...........................................................................
15
OVERDOSAGE
..............................................................................................................
24
ACTIONS AND CLINICAL
PHARMACOLOGY........................................................
24
STORAGE AND STABILITY
.......................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 28
PART II: SCIENTIFIC INFORMATION
.............................................................................
29
PHARMACEUTICAL INFORMATION
.......................................................................
29
DETAILED PHARMACOLOGY
.....................................................................