ALLEGRA 24 HOUR TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

FEXOFENADINE HYDROCHLORIDE

Disponibil de la:

SANOFI CONSUMER HEALTH INC

Codul ATC:

R06AX26

INN (nume internaţional):

FEXOFENADINE

Dozare:

120MG

Forma farmaceutică:

TABLET

Compoziție:

FEXOFENADINE HYDROCHLORIDE 120MG

Calea de administrare:

ORAL

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

OTC

Zonă Terapeutică:

SECOND GENERATION ANTIHISTAMINES

Rezumat produs:

Active ingredient group (AIG) number: 0131730002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2006-05-11

Caracteristicilor produsului

_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
........................