SANDOZ AZITHROMYCIN POWDER FOR SUSPENSION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)

Tilgængelig fra:

SANDOZ CANADA INCORPORATED

ATC-kode:

J01FA10

INN (International Name):

AZITHROMYCIN

Dosering:

200MG

Lægemiddelform:

POWDER FOR SUSPENSION

Sammensætning:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 200MG

Indgivelsesvej:

ORAL

Enheder i pakken:

600/900/1500MG

Recept type:

Prescription

Terapeutisk område:

OTHER MACROLIDES

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2009-09-08

Produktets egenskaber

_ _
_Sandoz Azithromycin _
_Page 1 of 90_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ AZITHROMYCIN
azithromycin dihydrate
Azithromycin, 100 mg / 5 mL, 200 mg / 5 mL for oral suspension
Azithromycin tablets, 250 mg for oral use
Manufacturer’s Standard
Antibacterial Agent
Sandoz Canada Inc.
Date of Initial Authorization:
110 rue de Lauzon
November 2, 2005
Boucherville, QC, Canada
J4B 1E6
Date of Revision:
October 25, 2023
Submission Control Number: 276289
_ _
_Sandoz Azithromycin _
_Page 2 of 90_
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
TABLE OF CONTENTS
................................................................................................................
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
.............................................................