Pays: Canada
Langue: anglais
Source: Health Canada
CEFAZOLIN (CEFAZOLIN SODIUM)
SANDOZ CANADA INCORPORATED
J01DB04
CEFAZOLIN
500MG
POWDER FOR SOLUTION
CEFAZOLIN (CEFAZOLIN SODIUM) 500MG
INTRAMUSCULAR
10X500MG
Prescription
FIRST GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0109442002; AHFS:
APPROVED
2008-04-18
_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 ......................... Lire le document complet