AURO-AZITHROMYCIN POWDER FOR SUSPENSION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)

Commercializzato da:

AURO PHARMA INC

Codice ATC:

J01FA10

INN (Nome Internazionale):

AZITHROMYCIN

Dosaggio:

200MG

Forma farmaceutica:

POWDER FOR SUSPENSION

Composizione:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 200MG

Via di somministrazione:

ORAL

Confezione:

15/22.5/37.5 ML

Tipo di ricetta:

Prescription

Area terapeutica:

OTHER MACROLIDES

Dettagli prodotto:

Active ingredient group (AIG) number: 0126072003; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2018-11-06

Scheda tecnica

Auro-Azithromycin Product Monograph
Page 1 of 78
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-AZITHROMYCIN
Azithromycin for Oral Suspension
Powder for Oral Suspension, 100 mg / 5 mL and 200 mg / 5 mL
azithromycin (as azithromycin
dihydrate) when reconstituted, for oral use
USP
Antibacterial Agent
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date
of Initial Authorization:
November 06, 2018
Date of Revision:
October 30, 2023
Submission Control Number: 276056
Auro-Azithromycin Product Monograph
Page 2 of 78
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.1 Pregnant
Women
10/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1 INDICATIONS
.......................................................................................................................
4
1.1 Pediatrics
...................................................................................................................
5
1.2
Geriatrics………………………………………………………………………………………………………………..6
2 CONTRAINDICATIONS
.........................................................................................................
6
4 DOSAGE AND ADMINISTRATION
.........................................................................................
7
4.1 Dosing Considerations
...............................................................................................
7
4.2 Recommended Dose and Dosage Adjustment
........................................................... 7
4.3 Reconstitution
.........................................................................................................
1