ALLEGRA-D TABLET (IMMEDIATE AND EXTENDED RELEASE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Διαθέσιμο από:

SANOFI CONSUMER HEALTH INC

Φαρμακολογική κατηγορία (ATC):

R01BA52

INN (Διεθνής Όνομα):

PSEUDOEPHEDRINE, COMBINATIONS

Δοσολογία:

60MG; 120MG

Φαρμακοτεχνική μορφή:

TABLET (IMMEDIATE AND EXTENDED RELEASE)

Σύνθεση:

FEXOFENADINE HYDROCHLORIDE 60MG; PSEUDOEPHEDRINE HYDROCHLORIDE 120MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

10/20/30

Τρόπος διάθεσης:

OTC

Θεραπευτική περιοχή:

SECOND GENERATION ANTIHISTAMINES

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0236381001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2000-06-02

Αρχείο Π.Χ.Π.

_ALLEGRA_
_®_
_-D (fexofenadine hydrochloride/pseudoephedrine hydrochloride) _
_Page 1 of 35 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ALLEGRA
®
-D
Fexofenadine hydrochloride and pseudoephedrine hydrochloride caplets
(Sustained-Release)
Caplets, 60 mg & 120 mg, Oral
Manufacturer’s Standard
Histamine H
1
-Receptor Antagonist/Sympathomimetic Amine
Sanofi Consumer Health Inc.
2905 Place Louis-R.-Renaud
Laval, Québec H7V 0A3
Date of Revision:
February 14, 2022
Submission Control Number: 253801
_ _
_ALLEGRA_
_®_
_-D (fexofenadine hydrochloride/pseudoephedrine hydrochloride) _
_Page 2 of 35 _
RECENT MAJOR LABEL CHANGES
Part 1, Health Professional Information
[05/2021]
Part 3, Patient Medication Information
[05/2021]
TABLE OF CONTENTS
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
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.3
Administration
.........................................................................................................
5
4.4
Missed D