AERIUS SYRUP
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
04-12-2014
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
DESLORATADINE
Fáanlegur frá:
BAYER INC
ATC númer:
R06AX27
INN (Alþjóðlegt nafn):
DESLORATADINE
Skammtar:
0.5MG
Lyfjaform:
SYRUP
Samsetning:
DESLORATADINE 0.5MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
OTC
Lækningarsvæði:
SECOND GENERATION ANTIHISTAMINES
Vörulýsing:
Active ingredient group (AIG) number: 0143961002; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2014-12-18
Vara einkenni
_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
......................
Lestu allt skjalið
