APO-CEFPROZIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-06-2020
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Active ingredient:
CEFPROZIL (CEFPROZIL MONOHYDRATE)
Available from:
APOTEX INC
ATC code:
J01DC10
INN (International Name):
CEFPROZIL
Dosage:
250MG
Pharmaceutical form:
TABLET
Composition:
CEFPROZIL (CEFPROZIL MONOHYDRATE) 250MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
SECOND GENERATION CEPHALOSPORINS
Product summary:
Active ingredient group (AIG) number: 0127613003; AHFS:
Authorization status:
APPROVED
Authorization date:
2007-03-09
Summary of Product characteristics
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
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