CEFAZOLIN FOR INJECTION, USP POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

CEFAZOLIN (CEFAZOLIN SODIUM)

Dostępny od:

FRESENIUS KABI CANADA LTD

Kod ATC:

J01DB04

INN (International Nazwa):

CEFAZOLIN

Dawkowanie:

100G

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

CEFAZOLIN (CEFAZOLIN SODIUM) 100G

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

100G

Typ recepty:

Prescription

Dziedzina terapeutyczna:

FIRST GENERATION CEPHALOSPORINS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0109442007; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2015-02-25

Charakterystyka produktu

_CEFAZOLIN FOR INJECTION, USP (Cefazolin for Injection) _
_Page 1 of 26 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CEFAZOLIN FOR INJECTION, USP
Cefazolin for Injection
Powder for Solution, 500 mg and 1 g cefazolin (as cefazolin sodium)
per Vial
Powder for Solution, 10 g and 20 g cefazolin (as cefazolin sodium) per
Pharmacy Bulk Vial
Powder for Solution, 100 g cefazolin (as cefazolin sodium) per
SmartPak
®
Pharmacy Bulk Package
Intramuscular, Intravenous
Antibiotic
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Initial Authorization:
JAN 28, 1998
Date of Revision:
SEP 13, 2022
Submission Control Number: 263265
_CEFAZOLIN FOR INJECTION, USP (Cefazolin for Injection) _
_Page 2 of 26 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Skin
09/2022
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
.............................................................................................................
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
4.2
Recommended Dose and Dosage Adjustment
................................................