CEFTAZIDIME FOR INJECTION, USP POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CEFTAZIDIME

Tersedia dari:

FRESENIUS KABI CANADA LTD

Kode ATC:

J01DD02

INN (Nama Internasional):

CEFTAZIDIME

Dosis:

2G

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

CEFTAZIDIME 2G

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

11.2ML

Jenis Resep:

Prescription

Area terapi:

THIRD GENERATION CEPHALOSPORINS

Ringkasan produk:

Active ingredient group (AIG) number: 0116900002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2006-10-05

Karakteristik produk

_ _
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
...............................................