Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
BETAHISTINE HYDROCHLORIDE
BGP PHARMA ULC
N07CA01
BETAHISTINE
24MG
TABLET
BETAHISTINE HYDROCHLORIDE 24MG
ORAL
100
Prescription
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Active ingredient group (AIG) number: 0103555004; AHFS:
APPROVED
2011-01-04
_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 .............. Přečtěte si celý dokument