AURO-CEFPROZIL TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

CEFPROZIL

Disponible desde:

AURO PHARMA INC

Código ATC:

J01DC10

Designación común internacional (DCI):

CEFPROZIL

Dosis:

250MG

formulario farmacéutico:

TABLET

Composición:

CEFPROZIL 250MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

SECOND GENERATION CEPHALOSPORINS

Resumen del producto:

Active ingredient group (AIG) number: 0127613003; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2010-04-09

Ficha técnica

Page 1 of 28
PRODUCT MONOGRAPH
PR
AURO-CEFPROZIL
(Cefprozil)
Tablets 250 mg & 500 mg
USP
ANTIBIOTIC
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision:
September 22, 2020
Submission control No.: 243286
Page 2 of 28
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
..............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
6
DRUG INTERACTIONS
.........................................................................................................
8
DOSAGE AND ADMINISTRATION
.....................................................................................
8
OVERDOSAGE
........................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY.
................................................................... 9
STORAGE AND STABILITY
..............................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 11
PART II: SCIENTIFIC INFORMATION
............................................................................
12
PHARMACEUTICAL INFORMATION
..............................................................................
12
CLINICAL TRIALS
..............................................................................................................
13
MICROBIOLOGY
............