CEFPROZIL TABLETS
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
09-10-2019
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Aktiv bestanddel:
CEFPROZIL (CEFPROZIL MONOHYDRATE)
Tilgængelig fra:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC-kode:
J01DC10
INN (International Name):
CEFPROZIL
Dosering:
500MG
Lægemiddelform:
TABLET
Sammensætning:
CEFPROZIL (CEFPROZIL MONOHYDRATE) 500MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
SECOND GENERATION CEPHALOSPORINS
Produkt oversigt:
Active ingredient group (AIG) number: 0127613002; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2009-08-20
Produktets egenskaber
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_Page 1 of 28_
PRODUCT MONOGRAPH
PR
CEFPROZIL TABLETS
CEFPROZIL TABLETS
(250 MG AND 500 MG OF CEFPROZIL AS CEFPROZIL MONOHYDRATE)
USP
ANTIBIOTIC
Ranbaxy Pharmaceuticals Canada Inc.
126 East Drive
Brampton, Ontario
L6T 1C1
DATE OF REVISION:
October 9, 2019
CONTROL NO: 231653
_ _
_ _
_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
...................................................................................................
7
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
10
OVERDOSAGE
...............................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 11
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 12
PART II: SCIENTIFIC INFORMATION
..............................................................................
13
PHARMACEUTICAL INFORMATION
.........................................................................
13
TOXICOLOGY
................................................................................................................
18
REFERENCES
.................................................................................................................
25
PART III: CONSUMER INFORMATION
.............................
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