Pays: Canada
Langue: anglais
Source: Health Canada
CEFPROZIL (CEFPROZIL MONOHYDRATE)
APOTEX INC
J01DC10
CEFPROZIL
250MG
TABLET
CEFPROZIL (CEFPROZIL MONOHYDRATE) 250MG
ORAL
100
Prescription
SECOND GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0127613003; AHFS:
APPROVED
2007-03-09
Page 1 of 27 PRODUCT MONOGRAPH PR APO-CEFPROZIL Cefprozil Tablets (cefprozil as cefprozil monohydrate) 250 mg and 500 mg cefprozil (on anhydrous basis) USP Antibiotic APOTEX INC. 150 Signet Drive Toronto, Ontario DATE OF REVISION: M9L 1T9 June 3, 2020 _Control Number: _235587 _ _ 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 ........................................................................................................................ 9 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 9 STORAGE AND STABILITY ............................................................................................... 11 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................. 11 PART II: SCIENTIFIC INFORMATION ............................................................................. 12 PHARMACEUTICAL INFORMATION ............................................................................... 12 CLINICAL TRIALS ............................................................................................................... 13 MIC Lire le document complet