TEVA-CIPROFLOXACIN TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)

Disponible des:

TEVA CANADA LIMITED

Codi ATC:

J01MA02

Designació comuna internacional (DCI):

CIPROFLOXACIN

Dosis:

750MG

formulario farmacéutico:

TABLET

Composición:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 750MG

Vía de administración:

ORAL

Unidades en paquete:

100/500/1000

tipo de receta:

Prescription

Área terapéutica:

QUINOLONES

Resumen del producto:

Active ingredient group (AIG) number: 0123207002; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2018-06-19

Fitxa tècnica

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