RIVA AZITHROMYCIN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE)

Disponible depuis:

LABORATOIRE RIVA INC.

Code ATC:

J01FA10

DCI (Dénomination commune internationale):

AZITHROMYCIN

Dosage:

600MG

forme pharmaceutique:

TABLET

Composition:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) 600MG

Mode d'administration:

ORAL

Unités en paquet:

6

Type d'ordonnance:

Prescription

Domaine thérapeutique:

OTHER MACROLIDES

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2013-07-31

Résumé des caractéristiques du produit

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PRODUCT MONOGRAPH
Pr
RIVA-AZITHROMYCIN
Azithromycin Tablets USP
250 mg and 600 mg
Antibiotic
LABORATOIRE RIVA INC.
660 Industriel blvd.
Blainville, Quebec, Canada.
J7C 3V4
www.labriva.com
Control No. 182319
Date of Revision:
March 17, 2015
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_RIVA-Azithromycin _
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_Page 2 of 56 _
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
......................................................................................
19
OVERDOSAGE
........................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
21
STORAGE AND STABILITY
.................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
.................................................................................
25
CLINICAL TRIALS
...................................................