Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
FOSAPREPITANT (FOSAPREPITANT DIMEGLUMINE)
MERCK CANADA INC
A04AD
OTHER ANTIEMETICS
115MG
POWDER FOR SOLUTION
FOSAPREPITANT (FOSAPREPITANT DIMEGLUMINE) 115MG
INTRAVENOUS
115ML
Prescription
NEUROKININ-1 RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0152547001; AHFS:
CANCELLED POST MARKET
2010-10-28
_ _ _Product Monograph - EMEND_ ® _ IV _ _Page 1 of 42_ PRODUCT MONOGRAPH PR EMEND ® IV fosaprepitant for injection 115 mg fosaprepitant /vial (as fosaprepitant dimeglumine) Neurokinin 1 (NK 1 ) receptor antagonist MERCK FROSST CANADA LTD. 16711 Trans Canada Highway Kirkland QC H9H 3L1 Canada www.merckfrosst.com Date of Revision: March 23, 2010 SUBMISSION CONTROL NO: 135170 EMEND ® is a Registered Trademark of Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Used under license. _ _ _Product Monograph - EMEND_ ® _ IV _ _Page 2 of 42_ 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....................................................................................................5 DRUG INTERACTIONS ....................................................................................................9 DOSAGE AND ADMINISTRATION..............................................................................14 OVERDOSAGE ................................................................................................................16 ACTION AND CLINICAL PHARMACOLOGY ............................................................17 STORAGE AND STABILITY..........................................................................................20 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................21 PART II: SCIENTIFIC INFORMATION ...............................................................................22 PHARMACEUTICAL INFORMATION............................... Đọc toàn bộ tài liệu