国: カナダ
言語: 英語
ソース: Health Canada
BOCEPREVIR; RIBAVIRIN; PEGINTERFERON ALFA-2B
MERCK CANADA INC
L03AB60
PEGINTERFERON ALFA-2B, COMBINATIONS
200MG; 200MG; 120MCG
CAPSULE
BOCEPREVIR 200MG; RIBAVIRIN 200MG; PEGINTERFERON ALFA-2B 120MCG
ORAL
168 BOC CAPS 70 RBV CAPS AND 2 REDIPEN
Prescription
INTERFERONS
Active ingredient group (AIG) number: 0352956003; AHFS:
CANCELLED POST MARKET
2016-09-02
_VICTRELIS TRIPLE_ ® _ (boceprevir, ribavirin plus peginterferon alfa-2b) _ _ Page 1 of 97 _ _ _ PRODUCT MONOGRAPH VICTRELIS TRIPLE ® VICTRELIS ® boceprevir capsules, 200 mg Hepatitis C Virus (HCV) Protease Inhibitor (PI) PLUS PEGETRON ® ribavirin capsules, 200 mg Antiviral Agent plus peginterferon alfa-2b powder for solution in CLEARCLICK TM single dose delivery system:_ _ 80 mcg/0.5 mL 100 mcg/0.5 mL 120 mcg/0.5 mL 150 mcg/0.5 mL, when reconstituted Biological Response Modifier NOTE: THESE PRODUCTS ARE INTENDED ONLY FOR USE AS DESCRIBED. THE INDIVIDUAL PRODUCTS CONTAINED IN VICTRELIS TRIPLE ® SHOULD NOT BE USED ALONE OR IN COMBINATION FOR OTHER PURPOSES. THE INFORMATION DESCRIBED IN THIS PRODUCT MONOGRAPH CONCERNS ONLY THE USE OF THESE PRODUCTS. FOR INFORMATION ON THE USE OF THE INDIVIDUAL COMPONENTS WHEN DISPENSED AS INDIVIDUAL MEDICATIONS OUTSIDE THIS COMBINED USE FOR THE TREATMENT OF CHRONIC HEPATITIS C (CHC), THE RESPECTIVE PRODUCT MONOGRAPHS FOR THESE PRODUCTS SHOULD BE CONSULTED. MERCK CANADA INC. 16750, route Transcanadienne Kirkland, QC Canada H9H 4M7 http://www.merck.ca SUBMISSION CONTROL NO: 185622 Date of Revision: September 11, 2015 _VICTRELIS TRIPLE_ ® _ (boceprevir, ribavirin plus peginterferon alfa-2b) _ _ Page 2 of 97 _ _ _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .......................................................... 3 SUMMARY PRODUCT INFORMATION ......................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................... 3 CONTRAINDICATIONS .................................................................................................... 4 ADVERSE REACTIONS ................................................................................................... 18 DRUG INTERACTIONS ................................................................................................... 28 DOSAGE AND ADMINISTRATION ......................................................... 完全なドキュメントを読む