Страна: Канада
Язык: английский
Источник: Health Canada
APREPITANT
MERCK CANADA INC
A04AD12
APREPITANT
80MG
CAPSULE
APREPITANT 80MG
ORAL
2
Prescription
NEUROKININ-1 RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0152292001; AHFS:
APPROVED
2007-08-24
_ _ _EMEND_ ® _(aprepitant capsules)_ _ _ _Page 1 of 40_ PRODUCT MONOGRAPH EMEND ® aprepitant capsules 80 and 125 mg Neurokinin 1 (NK 1 ) receptor antagonist MERCK CANADA INC. 16750 route Transcanadienne Kirkland, QC H9H 4M7 Canada www.merck.ca Date of Revision: January 22, 2014 SUBMISSION CONTROL NO: 168159 _ _ _EMEND_ ® _(aprepitant capsules)_ _ _ _Page 2 of 40_ 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 ..................................................................................................10 DOSAGE AND ADMINISTRATION ..............................................................................13 OVERDOSAGE ................................................................................................................15 ACTION AND CLINICAL PHARMACOLOGY ............................................................16 STORAGE AND STABILITY ..........................................................................................18 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................19 PART II: SCIENTIFIC INFORMATION ................................................................................20 PHARMACEUTICAL INFORMATION ..........................................................................20 CLINICAL TRIALS ..........................................................................................................20 DETAIL Прочитать полный документ