CEFTAZIDIME FOR INJECTION BP POWDER FOR SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

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Productkenmerken Productkenmerken (SPC)
02-05-2023

Werkstoffen:

CEFTAZIDIME (CEFTAZIDIME PENTAHYDRATE)

Beschikbaar vanaf:

STERIMAX INC

ATC-code:

J01DD02

INN (Algemene Internationale Benaming):

CEFTAZIDIME

Dosering:

6G

farmaceutische vorm:

POWDER FOR SOLUTION

Samenstelling:

CEFTAZIDIME (CEFTAZIDIME PENTAHYDRATE) 6G

Toedieningsweg:

INTRAVENOUS

Eenheden in pakket:

30ML

Prescription-type:

Prescription

Therapeutisch gebied:

THIRD GENERATION CEPHALOSPORINS

Product samenvatting:

Active ingredient group (AIG) number: 0116900009; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2015-02-27

Productkenmerken

                                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
_ _
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
.............................................................................................
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................ 6
4
DOSAGE AND ADMINISTRATION
...............................................................................
                                
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