IMODIUM CALMING LIQUID SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

LOPERAMIDE HYDROCHLORIDE

Доступна з:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

Код атс:

A07DA03

ІПН (Міжнародна Ім'я):

LOPERAMIDE

Дозування:

2MG

Фармацевтична форма:

SOLUTION

Склад:

LOPERAMIDE HYDROCHLORIDE 2MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

240ML

Тип рецепту:

OTC

Терапевтична области:

ANTIDIARRHEA AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0111332003; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2011-05-05

Характеристики продукта

_Product Monograph Master Template _
_Template Date: September 2020 _
_IMODIUM_
®
_Quick Dissolve, Loperamide Hydrochloride Tablets _
_IMODIUM_
®
_Calming Liquid, Loperamide Hydrochloride Oral Solution _
_IMODIUM_
®
_ LIQUI-GELS_
®
_, Loperamide Hydrochloride Capsules _
_Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
IMODIUM
® QUICK DISSOLVE
Loperamide Hydrochloride Tablets
Tablet (Orally Disintegrating), 2 mg, Oral
McNeil Std
and
IMODIUM
®
CALMING LIQUID
Loperamide Hydrochloride Oral Solution
Solution, 2 mg / 15 mL, Oral
McNeil Std
and
IMODIUM
® LIQUI-GELS
®
Loperamide Hydrochloride Capsules,
Capsule, 2 mg, Oral
McNeil Std
Antidiarrheal agent
McNeil Consumer Healthcare,
Division of Johnson & Johnson Inc.
88 McNabb Street
Markham, Ontario
L3R 5L2
Date of Initial Authorization:
IMODIUM
®
Quick Dissolve:
January 15, 1997
IMODIUM
®
Calming Liquid:
February 07, 2007
IMODIUM
®
LIQUI-GELS
®
:
November 10, 2011
Date of Revision:
December 2, 2022
Submission Control Number: 265788
LIQUI-GELS
®
is a registered trademark of Catalent Pharma Solutions, Inc., used
under license
_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_IMODIUM_
®
_Quick Dissolve, Loperamide Hydrochloride Tablets _
_IMODIUM_
®
_Calming Liquid, Loperamide Hydrochloride Oral Solution _
_IMODIUM_
®
_ LIQUI-GELS_
®
_, Loperamide Hydrochloride Capsules _
_Page 2 of 40_
RECENT MAJOR LABEL CHANGES
Section 4: Dosage and Administration – Addition of drug
withdrawal syndrome
Section 5: Overdosage – Addition of drug withdrawal
syndrome
Section 7: Warnings and Precautions – Addition of drug
withdrawal syndrome
Section 14: Clinical Trials – Addition of drug withdrawal
syndrome
06/2022
06/2022
06/2022
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 ...................................................