Страна: Канада
Език: английски
Източник: Health Canada
AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)
SANDOZ CANADA INCORPORATED
J01FA10
AZITHROMYCIN
200MG
POWDER FOR SUSPENSION
AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 200MG
ORAL
600/900/1500MG
Prescription
OTHER MACROLIDES
Active ingredient group (AIG) number: 0126072003; AHFS:
APPROVED
2009-09-08
_ _ _Sandoz Azithromycin _ _Page 1 of 90_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR SANDOZ AZITHROMYCIN azithromycin dihydrate Azithromycin, 100 mg / 5 mL, 200 mg / 5 mL for oral suspension Azithromycin tablets, 250 mg for oral use Manufacturer’s Standard Antibacterial Agent Sandoz Canada Inc. Date of Initial Authorization: 110 rue de Lauzon November 2, 2005 Boucherville, QC, Canada J4B 1E6 Date of Revision: October 25, 2023 Submission Control Number: 276289 _ _ _Sandoz Azithromycin _ _Page 2 of 90_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.1 Pregnant Women 10/2023 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 ................................................................................................................. 6 2 CONTRAINDICATIONS ................................................................................................... 6 4 DOSAGE AND ADMINISTRATION .................................................................................. 7 4.1 Dosing Considerations ............................................................................................. 7 4.2 Recommended Dose and Dosage Adjustment ......................................................... 7 4.3 Reconstitution ............................................................. Прочетете целия документ