MYLAN-CIPROFLOXACIN XL TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN)

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

J01MA02

INN (International Name):

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

Product summary:

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

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2016-11-02

Summary of Product characteristics

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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
...................................................