AERIUS SYRUP

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

DESLORATADINE

Pieejams no:

BAYER INC

ATĶ kods:

R06AX27

SNN (starptautisko nepatentēto nosaukumu):

DESLORATADINE

Deva:

0.5MG

Zāļu forma:

SYRUP

Kompozīcija:

DESLORATADINE 0.5MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

OTC

Ārstniecības joma:

SECOND GENERATION ANTIHISTAMINES

Produktu pārskats:

Active ingredient group (AIG) number: 0143961002; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2014-12-18

Produkta apraksts

_AERIUS Tablets / AERIUS Syrup / AERIUS KIDS Syrup _
_Page 1 of 37 _
PRODUCT MONOGRAPH
AERIUS
®
DESLORATADINE TABLET 5 MG
DESLORATADINE SYRUP 0.5 MG/ML
AERIUS KIDS
®
DESLORATADINE SYRUP 0.5 MG/ML
HISTAMINE H
1
-RECEPTOR ANTAGONIST
Bayer Inc., Consumer Care
2920 Matheson Blvd. E
Mississauga, ON
L4W 5R6
Date of Preparation:
December 4, 2014
Submission Control No: 179382, 179387
_AERIUS Tablets / AERIUS Syrup / AERIUS KIDS Syrup _
_Page 2 of 37 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................7
OVERDOSAGE
..................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND STABILITY
..........................................................................................11
SPECIAL HANDLING INSTRUCTIONS
.......................................................................11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................11
PART II: SCIENTIFIC INFORMATION
...............................................................................13
PHARMACEUTICAL INFORMATION
......................