Riik: Kanada
keel: inglise
Allikas: Health Canada
AZITHROMYCIN
PFIZER CANADA ULC
J01FA10
AZITHROMYCIN
500MG
POWDER FOR SOLUTION
AZITHROMYCIN 500MG
INTRAVENOUS
5ML
Prescription
OTHER MACROLIDES
Active ingredient group (AIG) number: 0126072006; AHFS:
APPROVED
1999-04-15
_ZITHROMAX (azithromycin dihydrate) - Product Monograph _ _Page 1 of 86_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ZITHROMAX ® azithromycin dihydrate Azithromycin tablets USP, 250 mg, 600 mg for oral use Azithromycin USP, 100 mg/5 mL, 200 mg/5 mL for oral suspension Azithromycin USP, 500 mg/vial, 100 mg/mL when reconstituted for Injection Antibacterial Agent Pfizer Canada ULC 17300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 Pfizer Canada ULC, Licensee © Pfizer Canada ULC 2022 Product Licensed from Pliva, Zagreb, Croatia Date of Initial Authorization: May 13, 1994 Date of Revision: April 27, 2023 Submission Control Number: 270217 _ _ _ZITHROMAX (azithromycin dihydrate) - Product Monograph_ _ _ _Page 2 of 86_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.1 Pregnant Women 04/2023 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 .......................................................................................................... 6 1.2 Geriatrics........................................................................................................... 7 2 CONTRAINDICATIONS ................................................................................................. 7 4 DOSAGE AND ADMINISTRATION................................................................................. 7 4.1 Dosing Considerations ....................................................................................... 7 Lugege kogu dokumenti