CEFPROZIL POWDER FOR ORAL SUSPENSION POWDER FOR SUSPENSION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
09-10-2019
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Active ingredient:
CEFPROZIL (CEFPROZIL MONOHYDRATE)
Available from:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC code:
J01DC10
INN (International Name):
CEFPROZIL
Dosage:
250MG
Pharmaceutical form:
POWDER FOR SUSPENSION
Composition:
CEFPROZIL (CEFPROZIL MONOHYDRATE) 250MG
Administration route:
ORAL
Units in package:
50/75/100ML
Prescription type:
Prescription
Therapeutic area:
SECOND GENERATION CEPHALOSPORINS
Product summary:
Active ingredient group (AIG) number: 0127613004; AHFS:
Authorization status:
APPROVED
Authorization date:
2009-08-20
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
CEFPROZIL POWDER FOR ORAL SUSPENSION
CEFPROZIL POWDER FOR ORAL SUSPENSION USP
(250 MG/5 ML OF CEFPROZIL AS CEFPROZIL MONOHYDRATE, WHEN
RECONSTITUTED)
USP
ANTIBIOTIC
Ranbaxy Pharmaceuticals Canada Inc.
126 East Drive,
Brampton, Ontario
L6T 1C1
Date of Revision:
October 9, 2019
Submission Control No.: 230902
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 4
SUMMARY PRODUCT INFORMATION
.................................................................................
4
INDICATIONS AND CLINICAL USE
.......................................................................................
4
CONTRAINDICATIONS
............................................................................................................
5
WARNINGS AND PRECAUTIONS
...........................................................................................
5
ADVERSE REACTIONS
.............................................................................................................
7
DRUG INTERACTIONS
.............................................................................................................
9
DOSAGE AND ADMINISTRATION
.........................................................................................
9
OVERDOSAGE
.........................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
11
STORAGE AND STABILITY
...................................................................................................
12
STORAGE OF RECONSTITUTED SUSPENSION
................................................................. 12
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................... 13
PART II: SCIENTIFIC INFORMATION
.....................................................................................
14
PHARMACEUTICAL INFORMATION
...................
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