MYLAN-CIPROFLOXACIN XL TABLET (EXTENDED-RELEASE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN)

MAH:

MYLAN PHARMACEUTICALS ULC

ATC_code:

J01MA02

INN:

CIPROFLOXACIN

dosage:

1000MG

pharmaceutical_form:

TABLET (EXTENDED-RELEASE)

composition:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN) 1000MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

QUINOLONES

leaflet_short:

Active ingredient group (AIG) number: 0123207009; AHFS:

authorization_status:

CANCELLED PRE MARKET

authorization_date:

2016-11-02

SPC

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_Page 1 of 54_
PRODUCT MONOGRAPH
Pr
MYLAN-CIPROFLOXACIN XL
(Ciprofloxacin hydrochloride and Ciprofloxacin Extended Release
Tablets)
Ciprofloxacin, 500 mg, 1000 mg
Antibacterial Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
May 25, 2015
Submission Control No: 184540
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_Page 2 of 54_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
10
DRUG INTERACTIONS
.........................................................................................................
15
DOSAGE AND ADMINISTRATION
.....................................................................................
21
OVERDOSAGE
.......................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 23
STORAGE AND STABILITY
.................................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 29
PART II: SCIENTIFIC INFORMATION
...............................................................................
30
PHARMACEUTICAL INFORMATION
.................................................................................
30
CLINICAL TRIALS
...................................................