Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
DESLORATADINE; PSEUDOEPHEDRINE SULFATE
BAYER INC
R01BA52
PSEUDOEPHEDRINE, COMBINATIONS
5MG; 240MG
TABLET (IMMEDIATE AND EXTENDED RELEASE)
DESLORATADINE 5MG; PSEUDOEPHEDRINE SULFATE 240MG
ORAL
100
OTC
SECOND GENERATION ANTIHISTAMINES
Active ingredient group (AIG) number: 0252460002; AHFS:
CANCELLED PRE MARKET
2021-07-21
_ _ _AERIUS_ _ DUAL ACTION 24 HOUR _ _Page 1 of 37_ PRODUCT MONOGRAPH AERIUS ® DUAL ACTION 24 HOUR DESLORATADINE 5 MG / PSEUDOEPHEDRINE SULFATE 240 MG MODIFIED RELEASE TABLETS HISTAMINE H1 RECEPTOR ANTAGONIST / SYMPATHOMIMETIC AMINE Bayer Inc., Consumer Care 2920 Matheson Blvd. E Mississauga, ON L4W 5R6 Date of Revision: July 10, 2015 Submission Control No: 184674 _ _ _AERIUS_ _ DUAL ACTION 24 HOUR _ _Page 2 of 37_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ....................................................................................................6 DRUG INTERACTIONS ....................................................................................................9 DOSAGE AND ADMINISTRATION ..............................................................................11 OVERDOSAGE ................................................................................................................11 ACTION AND CLINICAL PHARMACOLOGY ............................................................12 STORAGE AND STABILITY ..........................................................................................16 SPECIAL HANDLING INSTRUCTIONS .......................................................................16 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................16 PART II: SCIENTIFIC INFORMATION ...............................................................................17 PHARMACEUTICAL INFORMATION ............................................... Διαβάστε το πλήρες έγγραφο