ZITHROMAX FOR INTRAVENOUS INJECTION POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

AZITHROMYCIN

Disponibil de la:

PFIZER CANADA ULC

Codul ATC:

J01FA10

INN (nume internaţional):

AZITHROMYCIN

Dozare:

500MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

AZITHROMYCIN 500MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

5ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

OTHER MACROLIDES

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

1999-04-15

Caracteristicilor produsului

_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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
6
1.2
Geriatrics...........................................................................................................
7
2
CONTRAINDICATIONS
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7
4
DOSAGE AND
ADMINISTRATION.................................................................................
7
4.1
Dosing Considerations
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7