Ország: Kanada
Nyelv: angol
Forrás: Health Canada
AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)
ANGITA PHARMA INC.
J01FA10
AZITHROMYCIN
250MG
TABLET
AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 250MG
ORAL
6/100
Prescription
OTHER MACROLIDES
Active ingredient group (AIG) number: 0126072001; AHFS:
APPROVED
2018-09-10
Page 1 of 63 PRODUCT MONOGRAPH PR AG-AZITHROMYCIN Azithromycin Dihydrate Tablets 250 mg and 600 mg Azithromycin (supplied as azithromycin dihydrate), manufacturer’s standard Antibacterial Agent ANGITA PHARMA INC. DATE OF REVISION: 1310 RUE NOBEL, AUGUST 31, 2020 BOUCHERVILLE, QUÉBEC J4B 5H3 CONTROL # 241905 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 ................................................................................................ Olvassa el a teljes dokumentumot