Land: Canada
Språk: engelsk
Kilde: Health Canada
CEFPROZIL (CEFPROZIL MONOHYDRATE)
SUN PHARMA CANADA INC
J01DC10
CEFPROZIL
250MG
POWDER FOR SUSPENSION
CEFPROZIL (CEFPROZIL MONOHYDRATE) 250MG
ORAL
15G/50G
Prescription
SECOND GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0127613004; AHFS:
APPROVED
2007-04-10
Page 1 of 27 PRODUCT MONOGRAPH PR TARO-CEFPROZIL CEFPROZIL FOR ORAL SUSPENSION USP (125 MG/5 ML AND 250 MG/5 ML OF CEFPROZIL AS CEFPROZIL MONOHYDRATE, WHEN RECONSTITUTED) USP ANTIBIOTIC Sun Pharma Canada Inc. 126 East Drive Brampton, ON L6T 1C1 Date of Revision: September 21, 2020 Submission Control No: 242740 Page 2 of 27 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 ............................................................................................................... 6 DRUG INTERACTIONS ............................................................................................................... 8 DOSAGE AND ADMINISTRATION ........................................................................................... 8 OVERDOSAGE ........................................................................................................................... 10 ACTION AND CLINICAL PHARMACOLOGY ....................................................................... 10 STORAGE AND STABILITY ..................................................................................................... 11 STORAGE OF RECONSTITUTED SUSPENSION ................................................................... 12 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................................ 12 PART II: SCIENTIFIC INFORMATION ............................................................................... 13 PHARMACEUTICAL INFORMATION ............ read_full_document