国家: 加拿大
语言: 英文
来源: Health Canada
CLARITHROMYCIN
LABORATOIRE RIVA INC.
J01FA09
CLARITHROMYCIN
500MG
TABLET
CLARITHROMYCIN 500MG
ORAL
100/250
Prescription
OTHER MACROLIDES
Active ingredient group (AIG) number: 0123752002; AHFS:
CANCELLED POST MARKET
2022-09-02
_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 阅读完整的文件