AURO-CEFPROZIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-09-2020
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Active ingredient:
CEFPROZIL
Available from:
AURO PHARMA INC
ATC code:
J01DC10
INN (International Name):
CEFPROZIL
Dosage:
250MG
Pharmaceutical form:
TABLET
Composition:
CEFPROZIL 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:
2010-04-09
Summary of Product characteristics
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
............
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