MYLAN-AZITHROMYCIN TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE)

Disponible desde:

MYLAN PHARMACEUTICALS ULC

Código ATC:

J01FA10

Designación común internacional (DCI):

AZITHROMYCIN

Dosis:

250MG

formulario farmacéutico:

TABLET

Composición:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE) 250MG

Vía de administración:

ORAL

Unidades en paquete:

6/30

tipo de receta:

Prescription

Área terapéutica:

OTHER MACROLIDES

Resumen del producto:

Active ingredient group (AIG) number: 0126072001; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2018-03-09

Ficha técnica

PRODUCT MONOGRAPH
PR
MYLAN-AZITHROMYCIN
Azithromycin Tablets
250 mg
USP
ANTIBACTERIAL AGENT
MYLAN PHARMACEUTICALS ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Revision:
February 8, 2018
Control number: 213343
_ _
_MYLAN-AZITHROMYCIN Product Monograph _
_Page 2 of 62_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
CLINICAL TRIALS
..........................................................................................................27
DETAILED PHARMACOLOGY
..............................................................................