ACT BETAHISTINE TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

BETAHISTINE HYDROCHLORIDE

Dostupné z:

ACTAVIS PHARMA COMPANY

ATC kód:

N07CA01

INN (Medzinárodný Name):

BETAHISTINE

Dávkovanie:

16MG

Forma lieku:

TABLET

Zloženie:

BETAHISTINE HYDROCHLORIDE 16MG

Spôsob podávania:

ORAL

Počet v balení:

100

Typ predpisu:

Prescription

Terapeutické oblasti:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Prehľad produktov:

Active ingredient group (AIG) number: 0103555003; AHFS:

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2018-06-12

Súhrn charakteristických

_ _
_Product Monograph - _
ACT
_ _
BETAHISTINE
_ _
_Page 1 of 21_
PRODUCT MONOGRAPH
PR ACT BETAHISTINE
Betahistine dihydrochloride tablets, BP
16 MG AND 24 MG
ANTI-VERTIGO AGENT
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Date of Revision:
November 6, 2017
Submission Control No.: 210611
_ _
_Product Monograph - _
ACT
_ _
BETAHISTINE
_ _
_Page 2 of 21_
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
......................................................................................