PROPOFOL-II INJECTION EMULSION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PROPOFOL

Tersedia dari:

PFIZER CANADA ULC

Kode ATC:

N01AX10

INN (Nama Internasional):

PROPOFOL

Dosis:

10MG

Bentuk farmasi:

EMULSION

Komposisi:

PROPOFOL 10MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

20ML

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS GENERAL ANESTHETICS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2020-02-24

Karakteristik produk

_Product Monograph – _
_Pr_
_Propofol-II Injection _
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_Page 1 of 54_
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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 _
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_Page 2 of 54_
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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
.....................................................................