CEFTAZIDIME FOR INJECTION, USP POWDER FOR SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Preparatomtale Preparatomtale (SPC)
17-02-2022

Aktiv ingrediens:

CEFTAZIDIME

Tilgjengelig fra:

FRESENIUS KABI CANADA LTD

ATC-kode:

J01DD02

INN (International Name):

CEFTAZIDIME

Dosering :

6G

Legemiddelform:

POWDER FOR SOLUTION

Sammensetning:

CEFTAZIDIME 6G

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

30/60ML-(200-100MG/ML)

Resept typen:

Prescription

Terapeutisk område:

THIRD GENERATION CEPHALOSPORINS

Produkt oppsummering:

Active ingredient group (AIG) number: 0116900003; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2006-10-05

Preparatomtale

                                _ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CEFTAZIDIME FOR INJECTION, USP
1 g / vial, 2 g / vial, 6 g / vial
Sterile Powder for Solution
For Intramuscular or Intravenous Use
Antibiotic
ATC Code: J01DD02
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Initial Authorization:
MAR 24, 2015
Date of Revision:
FEB 17, 2022
Submission Control Number: 254560
_Product Monograph Master Template _
_ _
_Template Date: September 2020 _
_Ceftazidime for Injection, USP _
_ _
_Page 2 of 45 _
RECENT MAJOR LABEL CHANGES
SECTION
DATE
1 INDICATIONS
[02/2022]
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
[02/2022]
7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis,
Sensitivity/Resistance, Skin and Sodium Content
[02/2022]
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
[02/2022]
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
..................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................................4
1
INDICATIONS
..................................................................................................................4
1.1
Pediatrics
..............................................................................................................5
1.2
Geriatrics
..............................................................................................................5
2
CONTRAINDICATIONS......................................................................................................5
4
DOSAGE AND ADMINISTRATION
.......................................................................................5
4.1
Dosing Considerations
...............................................
                                
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