Land: Canada
Språk: engelsk
Kilde: Health Canada
DESLORATADINE
BAYER INC
R06AX27
DESLORATADINE
0.5MG
SYRUP
DESLORATADINE 0.5MG
ORAL
100
OTC
SECOND GENERATION ANTIHISTAMINES
Active ingredient group (AIG) number: 0143961002; AHFS:
APPROVED
2014-12-18
_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 ...................... Les hele dokumentet