CEFAZOLIN FOR INJECTION, USP POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

CEFAZOLIN (CEFAZOLIN SODIUM)

Sẵn có từ:

FRESENIUS KABI CANADA LTD

Mã ATC:

J01DB04

INN (Tên quốc tế):

CEFAZOLIN

Liều dùng:

20G

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

CEFAZOLIN (CEFAZOLIN SODIUM) 20G

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

100ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

FIRST GENERATION CEPHALOSPORINS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0109442004; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2023-03-16

Đặc tính sản phẩm

_CEFAZOLIN FOR INJECTION, USP (Cefazolin for Injection) _
_Page 1 of 26 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CEFAZOLIN FOR INJECTION, USP
Cefazolin for Injection
Powder for Solution, 500 mg and 1 g cefazolin (as cefazolin sodium)
per Vial
Powder for Solution, 10 g and 20 g cefazolin (as cefazolin sodium) per
Pharmacy Bulk Vial
Powder for Solution, 100 g cefazolin (as cefazolin sodium) per
SmartPak
®
Pharmacy Bulk Package
Intramuscular, Intravenous
Antibiotic
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Initial Authorization:
JAN 28, 1998
Date of Revision:
SEP 13, 2022
Submission Control Number: 263265
_CEFAZOLIN FOR INJECTION, USP (Cefazolin for Injection) _
_Page 2 of 26 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Skin
09/2022
7 WARNINGS AND PRECAUTIONS, Renal
09/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
5
1.2
Geriatrics
...................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................