CLARITHROMYCIN GRANULES FOR SUSPENSION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

CLARITHROMYCIN

متاح من:

SANIS HEALTH INC

ATC رمز:

J01FA09

INN (الاسم الدولي):

CLARITHROMYCIN

جرعة:

250MG

الشكل الصيدلاني:

GRANULES FOR SUSPENSION

تركيب:

CLARITHROMYCIN 250MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

105ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

OTHER MACROLIDES

ملخص المنتج:

Active ingredient group (AIG) number: 0123752004; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2013-07-26

خصائص المنتج

_CLARITHROMYCIN _
_Page 1 of 84 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CLARITHROMYCIN
Clarithromycin Tablets
Film-coated tablets, 250 mg and 500 mg, Oral
Manufacturer’s Standard
Antibiotic
NOTE: WHEN USED IN COMBINATION WITH ACID ANTISECRETORY DRUGS AND OTHER
ANTIMICROBIALS FOR THE ERADICATION OF HELICOBACTER PYLORI, THE PRODUCT
MONOGRAPH FOR THOSE AGENTS SHOULD BE CONSULTED.
Sanis Health Inc.
1 President’s Choice Circle
Brampton, Ontario
L6Y 5S5
Submission Control Number: 268808
Date of Initial Authorization:
MAR 22, 2021
Date of
Revision:
NOV
8, 2022
_CLARITHROMYCIN _
_Page 2 of 84 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
11/2022
7 WARNINGS AND PRECAUTIONS; 7.1.1 Pregnant Women; 7.1.2
Breast-feeding
11/2022
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
.......................................................................................................................
5
2
CONTRAINDICATIONS
....................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................ 6
4
DOSAGE AND ADMINISTRATION
....................................................................................
7
4.1 Dosing Considerations
............................................