ALLEGRA HIVES TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

FEXOFENADINE HYDROCHLORIDE

Disponível em:

SANOFI CONSUMER HEALTH INC

Código ATC:

R06AX26

DCI (Denominação Comum Internacional):

FEXOFENADINE

Dosagem:

60MG

Forma farmacêutica:

TABLET

Composição:

FEXOFENADINE HYDROCHLORIDE 60MG

Via de administração:

ORAL

Unidades em pacote:

15G/50G

Tipo de prescrição:

OTC

Área terapêutica:

SECOND GENERATION ANTIHISTAMINES

Resumo do produto:

Active ingredient group (AIG) number: 0131730001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2021-10-18

Características técnicas

_ALLEGRA_
_®_
_ 12 Hour (fexofenadine hydrochloride) _
_ALLEGRA_
_®_
_ 24 Hour (fexofenadine hydrochloride) _
_ALLEGRA_
_®_
_ HIVES (fexofenadine hydrochloride) _
_Page 1 of 35 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ALLEGRA
® 12 HOUR
Fexofenadine hydrochloride tablets
Tablets, 60 mg, Oral
Manufacturer’s Standard ALLEGRA
® 24 HOUR
Fexofenadine hydrochloride tablets
Tablets, 120 mg, Oral
Manufacturer’s Standard
ALLEGRA
® HIVES
Fexofenadine hydrochloride tablets
Tablets, 60 mg, Oral
Manufacturer’s Standard
Histamine H
1
Receptor Antagonist
Sanofi Consumer Health Inc.
2905 Place Louis-R. Renaud
Laval, QC H7V 0A3
Date of Revision:
October 5, 2021
Submission
Control Number: 252314
_ _
_ALLEGRA_
_®_
_ 12 Hour (fexofenadine hydrochloride) _
_ALLEGRA_
_®_
_ 24 Hour (fexofenadine hydrochloride) _
_ALLEGRA_
_®_
_ HIVES (fexofenadine hydrochloride) _
_Page 2 of 35_
RECENT MAJOR LABEL CHANGES
Patient Medication Information
04/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...............................................................................
2
TABLE OF CONTENTS
......................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 4
1
INDICATIONS .........................................................................................................
4
1.1
Pediatrics
...........................................................................................................
4
1.2
Geriatrics
...........................................................................................................
4
2
CONTRAINDICATIONS .........................................................................................
4
4
DOSAGE AND ADMINISTRATION ............................................................................
5
4.1 Dosing Considerations
........................