NRA-AZITHROMYCIN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)

Saatavilla:

NORA PHARMA INC

ATC-koodi:

J01FA10

INN (Kansainvälinen yleisnimi):

AZITHROMYCIN

Annos:

600MG

Lääkemuoto:

TABLET

Koostumus:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 600MG

Antoreitti:

ORAL

Kpl paketissa:

(3X10)/30/100/500

Prescription tyyppi:

Prescription

Terapeuttinen alue:

OTHER MACROLIDES

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2018-08-02

Valmisteyhteenveto

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
.................