NRA-AZITHROMYCIN TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)

Disponible desde:

NORA PHARMA INC

Código ATC:

J01FA10

Designación común internacional (DCI):

AZITHROMYCIN

Dosis:

600MG

formulario farmacéutico:

TABLET

Composición:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 600MG

Vía de administración:

ORAL

Unidades en paquete:

(3X10)/30/100/500

tipo de receta:

Prescription

Área terapéutica:

OTHER MACROLIDES

Resumen del producto:

Active ingredient group (AIG) number: 0126072005; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2018-08-02

Ficha técnica

PRODUCT MONOGRAPH
Pr
NRA-AZITHROMYCIN
Azithromycin Dihydrate Tablets
250 mg and 600 mg Azithromycin (supplied as azithromycin dihydrate),
manufacturer’s standard
Antibacterial Agent
Control #: 260531
Nora Pharma Inc.
40 rue Prince-Arthur, Suite 310
Saint-Lambert, Québec, J4P 1X2
Date of Revision:
February 3, 2022
NRA-AZITHROMYCIN Product Monograph
Page 2 of 64
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
..................................................................................................................
9
DRUG INTERACTIONS
................................................................................................................
15
DOSAGE AND ADMINISTRATION
............................................................................................
19
OVERDOSAGE
...............................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................
21
DETAILED PHARMACOLOGY).
.................................................................................................
22
STORAGE AND STABILITY
........................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................... 23
PART II: SCIENTIFIC INFORMATION
.................