Land: Canada
Sprog: engelsk
Kilde: Health Canada
AZITHROMYCIN
DOMINION PHARMACAL
J01FA10
AZITHROMYCIN
200MG
POWDER FOR SOLUTION
AZITHROMYCIN 200MG
ORAL
15/22.5ML
Prescription
OTHER MACROLIDES
Active ingredient group (AIG) number: 0126072003; AHFS:
CANCELLED PRE MARKET
2019-06-17
PRODUCT MONOGRAPH PR AZITHROMYCIN Azithromycin dihydrate (Powder for Oral Suspension 100 mg azithromycin/5 mL and 200 mg azithromycin/5 mL) USP Antibacterial Agent DOMINION PHARMACAL 6111 Royalmount Ave., Suite 100 Montréal, Canada H4P 2T4 1-888-550-6060 Date of Preparation: December 17, 2013 Submission Control No: 170490 _ _ AZITHROMYCIN_ Product Monograph _ _Page_ _ _ _2 of 69_ 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 ......................................................................................................... 10 DRUG INTERACTIONS ......................................................................................................... 17 DOSAGE AND ADMINISTRATION ..................................................................................... 21 OVERDOSAGE ........................................................................................................................ 26 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 26 STORAGE AND STABILITY ................................................................................................. 30 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................... 30 PART II: SCIENTIFIC INFORMATION ............................................................................... 31 PHARMACEUTICAL INFORMATION ................................................................................. 31 CLINICAL TRIALS . Læs hele dokumentet