CEFAZOLIN FOR INJECTION USP POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CEFAZOLIN (CEFAZOLIN SODIUM)

Disponibil de la:

SANDOZ CANADA INCORPORATED

Codul ATC:

J01DB04

INN (nume internaţional):

CEFAZOLIN

Dozare:

500MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

CEFAZOLIN (CEFAZOLIN SODIUM) 500MG

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

10X500MG

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

FIRST GENERATION CEPHALOSPORINS

Rezumat produs:

Active ingredient group (AIG) number: 0109442002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2008-04-18

Caracteristicilor produsului

_Cefazolin for Injection USP _
_Page 1 of 23_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR CEFAZOLIN FOR INJECTION USP
Cefazolin for Injection
Powder for Injection, 500 mg, 1 g & 10 g cefazolin (as cefazolin
sodium) per vial, Intravenous,
Intramuscular
USP
Antibiotic
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Initial Authorization:
April 18, 2008
Date of Revision:
September 7, 2022
Submission Control Number: 263209
_Cefazolin for Injection USP _
_Page 2 of 23_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Skin
11/2020
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
...........................................................................
3
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
............................................................. 5
4.3 RECONSTITUTIONS
..........................................................................................................
8
4.4 ADMINISTRATION
.........................