CEFTAZIDIME FOR INJECTION BP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFTAZIDIME (CEFTAZIDIME PENTAHYDRATE)

Available from:

STERIMAX INC

ATC code:

J01DD02

INN (International Name):

CEFTAZIDIME

Dosage:

2G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFTAZIDIME (CEFTAZIDIME PENTAHYDRATE) 2G

Administration route:

INTRAVENOUS

Units in package:

11.7ML

Prescription type:

Prescription

Therapeutic area:

THIRD GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0116900008; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-02-27

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CEFTAZIDIME FOR INJECTION BP
Powder for Solution,1 g, 2 g, 3 g and 6 g of ceftazidime (as
ceftazidime pentahydrate) per vial
Intravenous, Intramuscular
BP
Antibiotic
STERIMAX INC.
2770 Portland Drive
Oakville, ON L6H 6R4
Date of Initial Authorization:
February 23, 2015
Date of Revision:
May 2, 2023
Control No.: 269730
Ceftazidime for Injection BP
Page 2 of 60
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RECENT MAJOR LABEL CHANGES
SECTIONS
DATE
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
05/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Consideration, 4.2
Recommended Dose and Dosage Adjustment, 4.3 Reconstitution, 4.4
Administration
05/2023
7 WARNINGS AND PRECAUTIONS, Clostridium difficile-Associated
Disease, Immune, Neurologic, Renal, Skin
05/2023
8 ADVERSE REACTIONS, 8.2 Clinical Trial Adverse Reactions
05/2023
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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