Kraj: Kanada
Język: angielski
Źródło: Health Canada
CEFPROZIL
AURO PHARMA INC
J01DC10
CEFPROZIL
250MG
TABLET
CEFPROZIL 250MG
ORAL
100
Prescription
SECOND GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0127613003; AHFS:
APPROVED
2010-04-09
Page 1 of 28 PRODUCT MONOGRAPH PR AURO-CEFPROZIL (Cefprozil) Tablets 250 mg & 500 mg USP ANTIBIOTIC AURO PHARMA INC. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8, Canada. Date of Revision: September 22, 2020 Submission control No.: 243286 Page 2 of 28 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 MICROBIOLOGY ............ Przeczytaj cały dokument