TEVA-CIPROFLOXACIN TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
05-04-2018
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Aktiv ingrediens:
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)
Tilgjengelig fra:
TEVA CANADA LIMITED
ATC-kode:
J01MA02
INN (International Name):
CIPROFLOXACIN
Dosering :
750MG
Legemiddelform:
TABLET
Sammensetning:
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 750MG
Administreringsrute:
ORAL
Enheter i pakken:
100/500/1000
Resept typen:
Prescription
Terapeutisk område:
QUINOLONES
Produkt oppsummering:
Active ingredient group (AIG) number: 0123207002; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2018-06-19
Preparatomtale
1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-CIPROFLOXACIN
(Ciprofloxacin Hydrochloride Tablets)
USP
250 mg, 500 mg, 750 mg
Antibacterial Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Date of revision:
April 5, 2018
CONTROL NO.: 214056
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
6
WARNINGS AND PRECAUTIONS
........................................................................................
7
ADVERSE REACTIONS
........................................................................................................
12
DRUG INTERACTIONS
........................................................................................................
14
DOSAGE AND ADMINISTRATION
....................................................................................
20
OVERDOSAGE
.......................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 22
STORAGE AND STABILITY
................................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 24
PART II: SCIENTIFIC INFORMATION
......................................................................................
26
PHARMACEUTICAL INFORMATION
................................................................................
26
CLINICAL TRIALS
..............................................................................
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