M-CLARITHROMYCIN TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

CLARITHROMYCIN

Доступна з:

MANTRA PHARMA INC

Код атс:

J01FA09

ІПН (Міжнародна Ім'я):

CLARITHROMYCIN

Дозування:

250MG

Фармацевтична форма:

TABLET

Склад:

CLARITHROMYCIN 250MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

OTHER MACROLIDES

Огляд продуктів:

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

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2023-07-13

Характеристики продукта

_M-CLARITHROMYCIN (Clarithromycin tablets), Product Monograph _
_Page 1 of 69 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
M-CLARITHROMYCIN
Clarithromycin Tablets
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.
Mantra Pharma Inc.,
9150 Leduc Blvd., Suite 201
Brossard, Quebec
J4Y 0E3
Date of Initial Authorization:
January 03, 2018
_ _
Date of revision:
DEC 15, 2022
Submission Control Number: 270062
_ _
_M-CLARITHROMYCIN (Clarithromycin tablets), Product Monograph _
_Page 2 of 69 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
12/2022
7 WARNINGS AND PRECAUTIONS; 7.1.1 Pregnant Women; 7.1.2 Breast-
feeding
12/2022
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
.................................................................................
6
4.1
Dosing C