M-BETAHISTINE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

BETAHISTINE HYDROCHLORIDE

Disponible desde:

MANTRA PHARMA INC

Código ATC:

N07CA01

Designación común internacional (DCI):

BETAHISTINE

Dosis:

8MG

formulario farmacéutico:

TABLET

Composición:

BETAHISTINE HYDROCHLORIDE 8MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS THERAPEUTIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0103555002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2021-08-30

Ficha técnica

_M-Betahistine Product Monograph_
Page 1 of 20
PRODUCT MONOGRAPH
PR
M-BETAHISTINE
BETAHISTINE DIHYDROCHLORIDE TABLETS BP
8 MG, 16 MG AND 24 MG
ANTI-VERTIGO AGENT
MANTRA PHARMA INC.
9150 Boulevard Leduc, Suite 201
Brossard, QC, Canada
J4Y 0E3
DATE OF PREPARATION:
August 25, 2021
SUBMISSION CONTROL NO: 254780
_M-Betahistine Product Monograph_
Page 2 of 20
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
.......................................................................................
6
DOSAGE AND ADMINISTRATION
................................................................... 7
OVERDOSAGE
.....................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
................................................. 8
STORAGE AND STABILITY
.............................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................ 11
PART II: SCIENTIFIC INFORMATION
................................................................. 12
PHARMACEUTICAL INFORMATION
............................................................. 12
CLINICAL TRIALS
.............................................................................................
13
DETAILED PHARMACOLOGY
........................................................................
13
TOXICOLOGY
............................................................................................