ZITHROMAX FOR INTRAVENOUS INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AZITHROMYCIN

Available from:

PFIZER CANADA ULC

ATC code:

J01FA10

INN (International Name):

AZITHROMYCIN

Dosage:

500MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

AZITHROMYCIN 500MG

Administration route:

INTRAVENOUS

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

OTHER MACROLIDES

Product summary:

Active ingredient group (AIG) number: 0126072006; AHFS:

Authorization status:

APPROVED

Authorization date:

1999-04-15

Summary of Product characteristics

_ZITHROMAX (azithromycin dihydrate) - Product Monograph _
_Page 1 of 86_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ZITHROMAX
®
azithromycin dihydrate
Azithromycin tablets USP, 250 mg, 600 mg for oral use
Azithromycin USP, 100 mg/5 mL, 200 mg/5 mL for oral suspension
Azithromycin USP, 500 mg/vial, 100 mg/mL when reconstituted for
Injection
Antibacterial Agent
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Pfizer Canada ULC, Licensee
© Pfizer Canada ULC 2022
Product Licensed from Pliva, Zagreb, Croatia
Date of Initial Authorization:
May 13, 1994
Date of Revision:
April 27, 2023
Submission Control Number: 270217
_ _
_ZITHROMAX (azithromycin dihydrate) - Product Monograph_
_ _
_Page 2 of 86_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.1
Pregnant Women
04/2023
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
..........................................................................................................
6
1.2
Geriatrics...........................................................................................................
7
2
CONTRAINDICATIONS
.................................................................................................
7
4
DOSAGE AND
ADMINISTRATION.................................................................................
7
4.1
Dosing Considerations
.......................................................................................
7