RIVA-CLARITHROMYCIN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

CLARITHROMYCIN

Доступно од:

LABORATOIRE RIVA INC.

АТЦ код:

J01FA09

INN (Међународно име):

CLARITHROMYCIN

Дозирање:

500MG

Фармацеутски облик:

TABLET

Састав:

CLARITHROMYCIN 500MG

Пут администрације:

ORAL

Јединице у пакету:

100/250

Тип рецептора:

Prescription

Терапеутска област:

OTHER MACROLIDES

Резиме производа:

Active ingredient group (AIG) number: 0123752002; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2022-09-02

Карактеристике производа

_RIVA-CLARITHROMYCIN (clarithromycin) _
_Page 1 of 80_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RIVA-CLARITHROMYCIN
Clarithromycin Tablets, USP
Film-Coated Tablets, 250 mg and 500 mg, Oral
USP
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.
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Submission Control Number: 264945
Date of Initial Authorization:
June 16, 2010
Date of Revision:
July
5, 2022
_RIVA-CLARITHROMYCIN (clarithromycin) _
_Page 2 of 80_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
07/2022
7 WARNINGS AND PRECAUTIONS; 7.1.1 Pregnant Women; 7.1.2 Breast-feeding
07/2022
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
................................................................... 7
4
DOSAGE AND ADMINISTRATION
........................................................................................
7
4.1
Dos