SERC TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

BETAHISTINE HYDROCHLORIDE

Boleh didapati daripada:

BGP PHARMA ULC

Kod ATC:

N07CA01

INN (Nama Antarabangsa):

BETAHISTINE

Dos:

24MG

Borang farmaseutikal:

TABLET

Komposisi:

BETAHISTINE HYDROCHLORIDE 24MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0103555004; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2011-01-04

Ciri produk

_SERC_
_® _
_Product Monograph _
_Page 1 of 19 _
_Date of Revision: August 1, 2017 and Control No. 203694 _
PRODUCT MONOGRAPH
PR
SERC
®

betahistine dihydrochloride
tablets (16 mg and 24 mg)
Anti-vertigo Agent
®
Registered Trade-mark Abbott Products Operations AG, Licensed use by
BGP Pharma ULC,
Etobicoke, Ontario, M8Z 2S6
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Revision:
August 1, 2017
Submission Control No: 203694
_SERC_
_® _
_Product Monograph _
_Page 2 of 19 _
_Date of Revision: August 1, 2017 and Control No. 203694 _
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
....................................................................................................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
..............