国家: 加拿大
语言: 英文
来源: Health Canada
CLARITHROMYCIN
SUN PHARMA CANADA INC
J01FA09
CLARITHROMYCIN
250MG
TABLET
CLARITHROMYCIN 250MG
ORAL
100/500
Prescription
OTHER MACROLIDES
Active ingredient group (AIG) number: 0123752001; AHFS:
APPROVED
2022-06-02
TARO-CLARITHROMYCIN (Clarithromycin Tablets), TARO-CLARITHROMYCIN XL (Clarithromycin Extended-Release Tablets), RAN-CLARITHROMYCIN (Clarithromycin for Oral Suspension) Page 1 of 117 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TARO-CLARITHROMYCIN Clarithromycin Tablets Tablets, 250 mg and 500 mg, Oral USP PR TARO-CLARITHROMYCIN XL Clarithromycin Extended-Release Tablets Extended-Release Tablets, 500 mg, Oral Mfr. Std. PR RAN ™ -CLARITHROMYCIN Clarithromycin for Oral Suspension Powder for Suspension, 125 mg / 5 mL and 250 mg / 5 mL when reconstituted, 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. Sun Pharma Canada Inc., 126 East Drive Brampton, ON L6T 1C1 Date of Initial Authorization: December 04, 2014 Date of Revision: June 1, 2022 Submission Control Number: 259707 TARO-CLARITHROMYCIN (Clarithromycin Tablets), TARO-CLARITHROMYCIN XL (Clarithromycin Extended-Release Tablets), RAN-CLARITHROMYCIN (Clarithromycin for Oral Suspension) Page 2 of 117 RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 06/2022 7 WARNINGS AND PRECAUTIONS; 7.1.1 Pregnant Women; 7.1.2 Breast- feeding 06/2022 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 .......................................................................5 1 INDICATIONS.........................................................................................................................5 1.1 Pediatrics .........................................................................................................................7 1.2 Geriatrics .. 阅读完整的文件