TARO-CEFPROZIL POWDER FOR SUSPENSION
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
21-09-2020
Vissa dokument för denna produkt är för närvarande inte tillgängliga, du kan skicka en begäran till vår kundservice och vi kommer att meddela dig så snart vi kan få dem.
Skicka förfrågan.
Skicka förfrågan.
Aktiva substanser:
CEFPROZIL (CEFPROZIL MONOHYDRATE)
Tillgänglig från:
SUN PHARMA CANADA INC
ATC-kod:
J01DC10
INN (International namn):
CEFPROZIL
Dos:
250MG
Läkemedelsform:
POWDER FOR SUSPENSION
Sammansättning:
CEFPROZIL (CEFPROZIL MONOHYDRATE) 250MG
Administreringssätt:
ORAL
Enheter i paketet:
15G/50G
Receptbelagda typ:
Prescription
Terapiområde:
SECOND GENERATION CEPHALOSPORINS
Produktsammanfattning:
Active ingredient group (AIG) number: 0127613004; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2007-04-10
Produktens egenskaper
Page 1 of 27
PRODUCT MONOGRAPH
PR
TARO-CEFPROZIL
CEFPROZIL FOR ORAL SUSPENSION USP
(125 MG/5 ML AND 250 MG/5 ML OF CEFPROZIL AS CEFPROZIL MONOHYDRATE,
WHEN RECONSTITUTED)
USP
ANTIBIOTIC
Sun Pharma Canada Inc.
126 East Drive Brampton, ON
L6T 1C1
Date of Revision:
September 21, 2020
Submission Control No: 242740
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
...........................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
10
STORAGE AND STABILITY
.....................................................................................................
11
STORAGE OF RECONSTITUTED SUSPENSION
................................................................... 12
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 12
PART II: SCIENTIFIC INFORMATION
...............................................................................
13
PHARMACEUTICAL INFORMATION
............
Läs hela dokumentet
