CEFAZOLIN FOR INJECTION USP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFAZOLIN (CEFAZOLIN SODIUM)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

J01DB04

INN (International Name):

CEFAZOLIN

Dosage:

500MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFAZOLIN (CEFAZOLIN SODIUM) 500MG

Administration route:

INTRAMUSCULAR

Units in package:

10X500MG

Prescription type:

Prescription

Therapeutic area:

FIRST GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0109442002; AHFS:

Authorization status:

APPROVED

Authorization date:

2008-04-18

Summary of Product characteristics

_Cefazolin for Injection USP _
_Page 1 of 23_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR CEFAZOLIN FOR INJECTION USP
Cefazolin for Injection
Powder for Injection, 500 mg, 1 g & 10 g cefazolin (as cefazolin
sodium) per vial, Intravenous,
Intramuscular
USP
Antibiotic
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Initial Authorization:
April 18, 2008
Date of Revision:
September 7, 2022
Submission Control Number: 263209
_Cefazolin for Injection USP _
_Page 2 of 23_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Skin
11/2020
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
...........................................................................
3
1
INDICATIONS
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4
1.1 PEDIATRICS
...................................................................................................................
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
............................................................. 5
4.3 RECONSTITUTIONS
..........................................................................................................
8
4.4 ADMINISTRATION
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