AZITHROMYCIN TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)

Disponible des:

SANIS HEALTH INC

Codi ATC:

J01FA10

Designació comuna internacional (DCI):

AZITHROMYCIN

Dosis:

250MG

formulario farmacéutico:

TABLET

Composición:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 250MG

Vía de administración:

ORAL

Unidades en paquete:

6/100

tipo de receta:

Prescription

Área terapéutica:

OTHER MACROLIDES

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2017-05-03

Fitxa tècnica

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PRODUCT MONOGRAPH
PR
AZITHROMYCIN
Azithromycin Tablets
250 mg Azithromycin (as Azithromycin Dihydrate)
Manufacturer’s Standard
Antibacterial Agent
Sanis Health Inc.
Date of Revision:
1 President’s Choice Circle
March 5, 2019
Brampton, Ontario
L6Y 5S5
Submission Control No.: 225006
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_AZITHROMYCIN _
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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
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
20
OVERDOSAGE
................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 22
STORAGE AND STABILITY
.........................................................................................
25
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 26
PART II: SCIENTIFIC INFORMATION
..............................................................................
27
PHARMACEUTICAL INFORMATION
.........................................................................
27
CLINICAL TRIALS
.........................................................................................................
28
DETAILED PHARMACOLOG