PROPOFOL EMULSION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

PROPOFOL

Sẵn có từ:

BAXTER CORPORATION

Mã ATC:

N01AX10

INN (Tên quốc tế):

PROPOFOL

Liều dùng:

10MG

Dạng dược phẩm:

EMULSION

Thành phần:

PROPOFOL 10MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

20ML/50ML/100ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

MISCELLANEOUS GENERAL ANESTHETICS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2024-01-30

Đặc tính sản phẩm

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