IMODIUM COMPLETE CHEWABLE TABLETS TABLET (CHEWABLE)

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

Dostupné z:

MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC

ATC kód:

A07DA53

INN (Medzinárodný Name):

LOPERAMIDE, COMBINATIONS

Dávkovanie:

2MG; 125MG

Forma lieku:

TABLET (CHEWABLE)

Zloženie:

LOPERAMIDE HYDROCHLORIDE 2MG; SIMETHICONE 125MG

Spôsob podávania:

ORAL

Počet v balení:

5/10/20

Typ predpisu:

OTC

Terapeutické oblasti:

ANTIDIARRHEA AGENTS

Prehľad produktov:

Active ingredient group (AIG) number: 0231812001; AHFS:

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2014-05-21

Súhrn charakteristických

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PRODUCT MONOGRAPH
IMODIUM
®
Complete
Loperamide Hydrochloride, 2 mg/ Simethicone, 125 mg
Oral antidiarrheal/antiflatulent agent
McNeil Consumer Healthcare,
Division of Johnson & Johnson Inc.
88 McNabb St.
Markham, Ontario
L3R 5L2
Date of Revision:
May 22, 2019
Submission Control No: 225986
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
5
DRUG INTERACTIONS
...................................................................................................
8
DOSAGE AND ADMINISTRATION
...............................................................................
8
OVERDOSAGE
..................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 10
STORAGE AND STABILITY
.........................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 11
PART II: SCIENTIFIC INFORMATION
..............................................................................
12
PHARMACEUTICAL INFORMATION
.........................................................................
12
CLINICAL TRIALS
...........................................................................................