DIARRHEA RELIEF TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

LOPERAMIDE HYDROCHLORIDE

Tersedia dari:

LABORATOIRE RIVA INC.

Kode ATC:

A07DA03

INN (Nama Internasional):

LOPERAMIDE

Dosis:

2MG

Bentuk farmasi:

TABLET

Komposisi:

LOPERAMIDE HYDROCHLORIDE 2MG

Rute administrasi :

ORAL

Unit dalam paket:

250ML

Jenis Resep:

OTC

Area terapi:

ANTIDIARRHEA AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0111332001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2016-04-04

Karakteristik produk

PRODUCT MONOGRAPH
DIARRHEA RELIEF
Loperamide Hydrochloride Tablets, USP
Caplets: 2 mg
ORAL ANTIDIARRHEAL AGENT
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Québec
Canada J7C 3V4
www.labriva.com
SUBMISSION CONTROL NO: 243682
DATE OF REVISION:
December 7, 2020
_DIARRHEA RELIEF - Product Monograph _
_Page 2 of 30_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
................................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
.........................................................