CLARITHROMYCIN GRANULES FOR SUSPENSION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

CLARITHROMYCIN

から入手可能:

SANIS HEALTH INC

ATCコード:

J01FA09

INN（国際名）:

CLARITHROMYCIN

投薬量:

250MG

医薬品形態:

GRANULES FOR SUSPENSION

構図:

CLARITHROMYCIN 250MG

投与経路:

ORAL

パッケージ内のユニット:

105ML

処方タイプ:

Prescription

治療領域:

OTHER MACROLIDES

製品概要:

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

認証ステータス:

APPROVED

承認日:

2013-07-26

製品の特徴

_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
............................................