TARO-CEFPROZIL TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
18-09-2020
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Aktiva substanser:
CEFPROZIL (CEFPROZIL MONOHYDRATE)
Tillgänglig från:
SUN PHARMA CANADA INC
ATC-kod:
J01DC10
INN (International namn):
CEFPROZIL
Dos:
250MG
Läkemedelsform:
TABLET
Sammansättning:
CEFPROZIL (CEFPROZIL MONOHYDRATE) 250MG
Administreringssätt:
ORAL
Enheter i paketet:
100
Receptbelagda typ:
Prescription
Terapiområde:
SECOND GENERATION CEPHALOSPORINS
Produktsammanfattning:
Active ingredient group (AIG) number: 0127613003; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2020-01-06
Produktens egenskaper
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_Page 1 of 27_
PRODUCT MONOGRAPH
PR
TARO-CEFPROZIL
CEFPROZIL TABLETS
(250 MG AND 500 MG OF CEFPROZIL AS CEFPROZIL MONOHYDRATE)
USP
ANTIBIOTIC
Sun Pharma Canada Inc.
126 East Drive
Brampton, ON
L6T 1C1
Date of Revision:
September 18, 2020
CONTROL NO: 242660
_ _
_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
.......................................................................................................
7
DRUG INTERACTIONS
........................................................................................................
9
DOSAGE AND ADMINISTRATION
..................................................................................
10
OVERDOSAGE
....................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 11
STORAGE AND STABILITY
..............................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 12
PART II: SCIENTIFIC INFORMATION
..............................................................................
13
PHARMACEUTICAL INFORMATION
..............................................................................
13
CLINICAL TRIALS
..............................................................................................................
14
MICROBIOLOGY
....................
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