AERIUS DOUBLE ACTION 12 HOUR TABLET (EXTENDED-RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

DESLORATADINE; PSEUDOEPHEDRINE SULFATE

Disponibil de la:

BAYER INC

Codul ATC:

R01BA52

INN (nume internaţional):

PSEUDOEPHEDRINE, COMBINATIONS

Dozare:

2.5MG; 120MG

Forma farmaceutică:

TABLET (EXTENDED-RELEASE)

Compoziție:

DESLORATADINE 2.5MG; PSEUDOEPHEDRINE SULFATE 120MG

Calea de administrare:

ORAL

Unități în pachet:

2/4/7/10/14/20/30

Tip de prescriptie medicala:

OTC

Zonă Terapeutică:

SECOND GENERATION ANTIHISTAMINES

Rezumat produs:

Active ingredient group (AIG) number: 0252460001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2014-12-05

Caracteristicilor produsului

_< AERIUS® SINUS + ALLERGY > _
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_< Desloratadine 2.5 mg & Pseudoephedrine sulfate 120 mg> _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
AERIUS® SINUS + ALLERGY
Desloratadine and Pseudoephedrine sulfate Extended-Release Tablets
Extended-release tablets, Desloratadine 2.5 mg / Pseudoephedrine
Sulfate 120 mg, Oral
Histamine H1 Receptor Antagonist / Sympathomimetic Amine
Bayer Inc
Date of Authorization: February 1
st
, 2010
2920 Matheson Blvd. E
Date of Revision: February 20
th
, 2024
Mississauga, ON
L4W 5R6
Submission Control Number: 278741
® TM see www.bayer.ca/tm-mc
_ _
_< AERIUS® SINUS + ALLERGY > _
_ _
_<_
_Desloratadine 2.5 mg & Pseudoephedrine sulfate 120 mg> _
_Page 2 of 36_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4
1 INDICATIONS ...........................................................................................................................
4
1.1 Pediatrics
...............................................................................................................................
4
1.2 Geriatrics
...............................................................................................................................
4
2 CONTRAINDICATIONS .............................................................................................................
4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX ......................................................................
4
4 DOSAGE AND ADMINISTRATION ............................................................................................
5
4.1 Dosing Considerations
..........................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
.....................................................................
5
4.4 Administration
...............................