TEVA-CIPROFLOXACIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
05-04-2018
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Active ingredient:
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)
Available from:
TEVA CANADA LIMITED
ATC code:
J01MA02
INN (International Name):
CIPROFLOXACIN
Dosage:
750MG
Pharmaceutical form:
TABLET
Composition:
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 750MG
Administration route:
ORAL
Units in package:
100/500/1000
Prescription type:
Prescription
Therapeutic area:
QUINOLONES
Product summary:
Active ingredient group (AIG) number: 0123207002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-06-19
Summary of Product characteristics
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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