Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
CEFAZOLIN (CEFAZOLIN SODIUM)
STERIMAX INC
J01DB04
CEFAZOLIN
2G
POWDER FOR SOLUTION
CEFAZOLIN (CEFAZOLIN SODIUM) 2G
INTRAMUSCULAR
15G/50G
Prescription
Active ingredient group (AIG) number: 0109442010; AHFS:
APPROVED
2022-02-11
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR CEFAZOLIN SODIUM FOR INJECTION BP Powder for Solution, 1 gram, 2 grams and 10 grams Cefazolin (as cefazolin sodium) per vial Intravenous, Intramuscular BP Antibiotic SteriMax Inc. Date of Initial Authorization: JUN 24, 2020 2770 Portland Drive Oakville, ON Date of Revision: SEP 14, 2022 L6H 6R4 Control No: 263261 Pr CEFAZOLIN SODIUM FOR INJECTION BP Page 2 of 21 RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, SKIN 01/2021 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 .................................................................... 5 4.3 Reconstitution ...................................................................................................................... 7 4.4 Administration ................................................................................. Přečtěte si celý dokument