Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)
MARCAN PHARMACEUTICALS INC
J01FA10
AZITHROMYCIN
600MG
TABLET
AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 600MG
ORAL
30/100/500
Prescription
OTHER MACROLIDES
Active ingredient group (AIG) number: 0126072005; AHFS:
APPROVED
2016-09-08
Page 1 of 63 PRODUCT MONOGRAPH Pr MAR-AZITHROMYCIN Azithromycin Dihydrate Tablets 250 mg and 600 mg Azithromycin (supplied as azithromycin dihydrate), manufacturer’s standard Antibacterial Agent Marcan Pharmaceuticals Inc. Date of Revision: 2 Gurdwara Road, Suite #112 August 12, 2020 Ottawa, Ontario Canada, K2E 1A2 Control Number: 241406 Page 2 of 63 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ............................................................................. 3 SUMMARY PRODUCT INFORMATION .............................................................................................. 3 INDICATIONS AND CLINICAL USE ................................................................................................... 3 CONTRAINDICATIONS ......................................................................................................................... 4 WARNINGS AND PRECAUTIONS ....................................................................................................... 4 ADVERSE REACTIONS ......................................................................................................................... 8 DRUG INTERACTIONS ....................................................................................................................... 14 DOSAGE AND ADMINISTRATION ................................................................................................... 19 OVERDOSAGE ...................................................................................................................................... 20 ACTION AND CLINICAL PHARMACOLOGY .................................................................................. 20 STORAGE AND STABILITY ............................................................................................................... 23 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................................... 23 PART II: SCIENTIFIC INFORMATION .................................................................. Perskaitykite visą dokumentą