Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
CEFAZOLIN (CEFAZOLIN SODIUM)
HIKMA CANADA LIMITED
J01DB04
CEFAZOLIN
500MG
POWDER FOR SOLUTION
CEFAZOLIN (CEFAZOLIN SODIUM) 500MG
INTRAMUSCULAR
15G/50G
Prescription
FIRST GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0109442002; AHFS:
APPROVED
2015-02-04
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR CEFAZOLIN FOR INJECTION Powder for Solution, 500 mg, 1 gram and 10 grams cefazolin (as cefazolin sodium) per vial, Intravenous, Intramuscular Manufacturer’s Standard Antibiotic Hikma Canada Limited 5995 Avebury Road, Suite 804 Mississauga, Ontario L5R 3P9 Date of Initial Authorization: JUN 21, 2023 Submission Control Number: 276118 Page 2 of 23 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 ........................................................................................................... 8 4.4 Administration .......................................................................................................... 9 5 OVERDOSAGE...................................................... Belgenin tamamını okuyun