국가: 캐나다
언어: 영어
출처: Health Canada
DROTRECOGIN ALFA (ACTIVATED)
ELI LILLY CANADA INC
B01AD10
DROTRECOGIN ALFA
5MG
POWDER FOR SOLUTION
DROTRECOGIN ALFA (ACTIVATED) 5MG
INTRAVENOUS
2.5ML
Prescription
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0148944001; AHFS:
CANCELLED POST MARKET
2011-11-14
_ _ _XIGRIS [drotrecogin alfa (activated)] _ _Page 1 of 36 _ _Product Monograph _ _ _ PRODUCT MONOGRAPH Pr XIGRIS ® drotrecogin alfa (activated) Sterile Powder for Intravenous Injection 5 mg or 20 mg drotrecogin alfa (activated) per vial ANTITHROMBOTIC PROFIBRINOLYTIC ANTI-INFLAMMATORY ENZYME © ELI LILLY CANADA INC. 3650 Danforth Avenue Toronto, Ontario M1N 2E8 1-888-545-5972 www.lilly.ca Date of Approval: August 20, 2009 Submission Control No: 128989 _ _ _XIGRIS [drotrecogin alfa (activated)] _ _Page 2 of 36 _ _Product Monograph _ _ _ 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................................................................................................... 8 DRUG INTERACTIONS ................................................................................................. 12 DOSAGE AND ADMINISTRATION ............................................................................. 13 OVERDOSAGE ............................................................................................................... 16 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 16 STORAGE AND STABILITY......................................................................................... 19 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 19 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 20 PART II: SCIENTIFIC INFORMATION ............................................. 전체 문서 읽기