MYLAN-CIPROFLOXACIN XL TABLET (EXTENDED-RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN)

Disponibil de la:

MYLAN PHARMACEUTICALS ULC

Codul ATC:

J01MA02

INN (nume internaţional):

CIPROFLOXACIN

Dozare:

500MG

Forma farmaceutică:

TABLET (EXTENDED-RELEASE)

Compoziție:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN) 500MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

QUINOLONES

Rezumat produs:

Active ingredient group (AIG) number: 0123207001; AHFS:

Statutul autorizaţiei:

CANCELLED PRE MARKET

Data de autorizare:

2016-11-02

Caracteristicilor produsului

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