CEFAZOLIN FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFAZOLIN (CEFAZOLIN SODIUM)

Available from:

TEVA CANADA LIMITED

ATC code:

J01DB04

INN (International Name):

CEFAZOLIN

Dosage:

10G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFAZOLIN (CEFAZOLIN SODIUM) 10G

Administration route:

INTRAVENOUS

Units in package:

1

Prescription type:

Prescription

Therapeutic area:

FIRST GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0109442003; AHFS:

Authorization status:

APPROVED

Authorization date:

2013-04-12

Summary of Product characteristics

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_CEFAZOLIN FOR INJECTION Product Monograph Page 1 of 21 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CEFAZOLIN FOR INJECTION
POWDER FOR SOLUTION, 500 MG, 1.0 G AND 10.0 G, CEFAZOLIN (AS CEFAZOLIN
SODIUM) PER VIAL
Intravenous, Intramuscular
USP
Antibiotic
Teva Canada Limited
Date of Initial Authorization:
30 Novopharm Court
January 19, 1995
Toronto, Ontario
M1B 2K9
Date of Revision:
Canada
MAR 15, 2024
www.tevacanada.com
Submission Control Number: 265641
_Pr_
_CEFAZOLIN FOR INJECTION (Cefazolin Sodium) Product Monograph Page 2
of 21 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
11/2020
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
......................................................... 3
1 INDICATIONS
..........................................................................................................................
3
2 CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.2 Recommended Dose and Dosage Adjustment
......................................................................
4
4.3 Reconstitution
.......................................................................................................................
6
4.4 Administration
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8
5 OVERDOSAGE
.........................................................................................................................
8
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKA