PMS-LOPERAMIDE HYDROCHLORIDE SOLUTION.2MG/ML

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

LOPERAMIDE HYDROCHLORIDE

Предлага се от:

PHARMASCIENCE INC

АТС код:

A07DA03

INN (Международно Name):

LOPERAMIDE

дозиране:

0.2MG

Лекарствена форма:

SOLUTION

Композиция:

LOPERAMIDE HYDROCHLORIDE 0.2MG

Начин на приложение:

ORAL

Броя в опаковка:

230ML

Вид предписание :

OTC

Терапевтична област:

ANTIDIARRHEA AGENTS

Каталог на резюме:

Active ingredient group (AIG) number: 0111332002; AHFS:

Статус Оторизация:

MARKETED

Дата Оторизация:

1993-12-31

Данни за продукта

_pms-LOPERAMIDE & pms-LOPERAMIDE HYDROCHLORIDE SOLUTION Product
Monograph _
_Page 1 of 38 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PMS-LOPERAMIDE
Loperamide Hydrochloride Tablets
Caplet, 2 mg, oral
USP
and
PMS-LOPERAMIDE HYDROCHLORIDE SOLUTION
Loperamide Hydrochloride Oral Solution
Solution, 0.2 mg / mL, Oral
USP
Antidiarrheal agent
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
pms-LOPERAMIDE HYDROCHLORIDE SOLUTION:
June 2, 1993
pms-LOPERAMIDE
August 2, 1996
Date of Revision:
June 26, 2023
Submission Control Number: 272133
_pms-LOPERAMIDE & pms-LOPERAMIDE HYDROCHLORIDE SOLUTION Product
Monograph _
_Page 2 of 38 _
_ _
RECENT MAJOR LABEL CHANGES
5 OVERDOSAGE, Addition of drug withdrawal syndrome
06/2022
7 WARNINGS AND PRECAUTIONS, Addition of drug withdrawal syndrome
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
................................................................................
4
1
INDICATIONS
........................................................................................................................
4
1.1
Pediatrics
...........................................................................................................................
4
1.2
Geriatrics
............................................................................................................................
4
2
CONTRAINDICATIONS
...........................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.....................................................................