国: カナダ
言語: 英語
ソース: Health Canada
AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE)
ACTAVIS PHARMA COMPANY
J01FA10
AZITHROMYCIN
250MG
TABLET
AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) 250MG
ORAL
6/30/100
Prescription
OTHER MACROLIDES
Active ingredient group (AIG) number: 0126072001; AHFS:
CANCELLED POST MARKET
2018-06-12
_ _ _Page 1 of 66 _ PRODUCT MONOGRAPH Pr ACT AZITHROMYCIN Azithromycin Tablets USP 250 mg and 600 mg Antibiotic Actavis Pharma Company 6733 Mississauga Road, Suite 400 Mississauga, Ontario L5N 6J5 Date of Revision: October 07, 2016 Control No: 198611 _ _ _Page 2 of 66 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .......................................................3 SUMMARY PRODUCT INFORMATION ......................................................................................................... 3 INDICATIONS AND CLINICAL USE .............................................................................................................. 3 CONTRAINDICATIONS .................................................................................................................................. 5 WARNINGS AND PRECAUTIONS .................................................................................................................. 5 ADVERSE REACTIONS ................................................................................................................................... 9 DRUG INTERACTIONS ................................................................................................................................. 15 DOSAGE AND ADMINISTRATION .............................................................................................................. 19 OVERDOSAGE ............................................................................................................................................... 20 ACTION AND CLINICAL PHARMACOLOGY ............................................................................................. 21 STORAGE AND STABILITY ......................................................................................................................... 23 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................................................... 24 PART II: SCIENTIFIC INFORMATION .......................................................... 完全なドキュメントを読む