MYLAN-CIPROFLOXACIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
16-08-2017
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Active ingredient:
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
J01MA02
INN (International Name):
CIPROFLOXACIN
Dosage:
750MG
Pharmaceutical form:
TABLET
Composition:
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 750MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
QUINOLONES
Product summary:
Active ingredient group (AIG) number: 0123207002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-12-12
Summary of Product characteristics
Page 1 of 57
PRODUCT MONOGRAPH
PR
MYLAN-CIPROFLOXACIN
CIPROFLOXACIN TABLETS, USP
250 MG, 500 MG AND 750 MG
(AS CIPROFLOXACIN HYDROCHLORIDE)
ANTIBACTERIAL AGENT
MYLAN PHARMACEUTICALS ULC
85 Advance Road
Etobicoke, Ontario
Canada
M8Z 2S6
Date of Revision: AUGUST 09, 2017
Control No.: 207057
Page 2 of 57
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
.............................................................................................................
13
DRUG
INTERACTIONS
.............................................................................................................
16
DOSAGE
AND
ADMINISTRATION
.........................................................................................
23
OVERDOSAGE
...........................................................................................................................
26
ACTION
AND
CLINICAL
PHARMACOLOGY
........................................................................
26
STORAGE
AND
STABILITY
.....................................................................................................
29
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ......................................................... 29
PART II: SCIENTIFIC INFORMATION
...............................................................................
30
PHARMACEUTICAL
INFORMATION
.....................................................................................
30
CLINICAL
TRIALS
....................................
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