ZITHROMAX - PWS ORL 100MG/5ML POWDER FOR SUSPENSION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

AZITHROMYCIN

متاح من:

PFIZER CANADA ULC

ATC رمز:

J01FA10

INN (الاسم الدولي):

AZITHROMYCIN

جرعة:

100MG

الشكل الصيدلاني:

POWDER FOR SUSPENSION

تركيب:

AZITHROMYCIN 100MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

15 ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

OTHER MACROLIDES

ملخص المنتج:

Active ingredient group (AIG) number: 0126072002; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2013-01-15

خصائص المنتج

_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
.....................................................................
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