DORIBAX POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

DORIPENEM (DORIPENEM MONOHYDRATE)

Sẵn có từ:

JANSSEN INC

Mã ATC:

J01DH04

INN (Tên quốc tế):

DORIPENEM

Liều dùng:

500MG

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

DORIPENEM (DORIPENEM MONOHYDRATE) 500MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

500ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

CARBAPENEMS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0152649001; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2013-07-03

Đặc tính sản phẩm

_DORIBAX 163140 APM.doc _
_ _
_Page 1 of 47 _
PRODUCT MONOGRAPH
PR
DORIBAX
®
Doripenem for Injection
500 mg/vial doripenem (as doripenem monohydrate)
Antibacterial Agent
ATC code: J01DH04
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.ca
Date of Revision:
June 14, 2013
Submission Control No: 163140
All trademarks used under license.
© 2013 Janssen Inc.
_DORIBAX 163140 APM.doc _
_ _
_Page 2 of 47 _
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
............................................................................................................................................
12
DOSAGE AND ADMINISTRATION
........................................................................................................................
13
OVERDOSAGE
..........................................................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
......................................................................................................
17
STORAGE AND STABILITY
.........................................................................................