CEFAZOLIN FOR INJECTION, USP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFAZOLIN (CEFAZOLIN SODIUM)

Available from:

FRESENIUS KABI CANADA LTD

ATC code:

J01DB04

INN (International Name):

CEFAZOLIN

Dosage:

100G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFAZOLIN (CEFAZOLIN SODIUM) 100G

Administration route:

INTRAVENOUS

Units in package:

100G

Prescription type:

Prescription

Therapeutic area:

FIRST GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0109442007; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-02-25

Summary of Product characteristics

_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) _
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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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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5
1.2
Geriatrics
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5
2
CONTRAINDICATIONS
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5
4
DOSAGE AND ADMINISTRATION
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5
4.2
Recommended Dose and Dosage Adjustment
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