Nazione: Canada
Lingua: inglese
Fonte: Health Canada
CEFTAZIDIME (CEFTAZIDIME PENTAHYDRATE)
STERIMAX INC
J01DD02
CEFTAZIDIME
6G
POWDER FOR SOLUTION
CEFTAZIDIME (CEFTAZIDIME PENTAHYDRATE) 6G
INTRAVENOUS
30ML
Prescription
THIRD GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0116900009; AHFS:
APPROVED
2015-02-27
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR CEFTAZIDIME FOR INJECTION BP Powder for Solution,1 g, 2 g, 3 g and 6 g of ceftazidime (as ceftazidime pentahydrate) per vial Intravenous, Intramuscular BP Antibiotic STERIMAX INC. 2770 Portland Drive Oakville, ON L6H 6R4 Date of Initial Authorization: February 23, 2015 Date of Revision: May 2, 2023 Control No.: 269730 Ceftazidime for Injection BP Page 2 of 60 _ _ RECENT MAJOR LABEL CHANGES SECTIONS DATE 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 05/2023 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Consideration, 4.2 Recommended Dose and Dosage Adjustment, 4.3 Reconstitution, 4.4 Administration 05/2023 7 WARNINGS AND PRECAUTIONS, Clostridium difficile-Associated Disease, Immune, Neurologic, Renal, Skin 05/2023 8 ADVERSE REACTIONS, 8.2 Clinical Trial Adverse Reactions 05/2023 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 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................ 6 4 DOSAGE AND ADMINISTRATION ............................................................................... Leggi il documento completo