RIVA-CLARITHROMYCIN TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

CLARITHROMYCIN

可用日期:

LABORATOIRE RIVA INC.

ATC代码:

J01FA09

INN（国际名称）:

CLARITHROMYCIN

剂量:

250MG

药物剂型:

TABLET

组成:

CLARITHROMYCIN 250MG

给药途径:

ORAL

每包单位数:

100

处方类型:

Prescription

治疗领域:

OTHER MACROLIDES

產品總結:

Active ingredient group (AIG) number: 0123752001; AHFS:

授权状态:

CANCELLED PRE MARKET

授权日期:

2023-07-21

产品特点

_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