Country: Canada
Language: English
Source: Health Canada
RIBAVIRIN; PEGINTERFERON ALFA-2B
MERCK CANADA INC
L03AB60
PEGINTERFERON ALFA-2B, COMBINATIONS
200MG; 120MCG
CAPSULE
RIBAVIRIN 200MG; PEGINTERFERON ALFA-2B 120MCG
ORAL
2X0.7ML-35CAPS
Prescription
INTERFERONS
Active ingredient group (AIG) number: 0247602004; AHFS:
CANCELLED POST MARKET
2013-01-23
PR PEGETRON ® (RIBAVIRIN + PEGINTERFERON ALFA-2B) PRODUCT MONOGRAPH PAGE 1 OF 76 PRODUCT MONOGRAPH PEGETRON ® RIBAVIRIN PLUS PEGINTERFERON ALFA-2B RIBAVIRIN 200 MG CAPSULES PLUS PEGINTERFERON ALFA-2B POWDER FOR SOLUTION IN VIALS : 50 MCG/0.5 ML 80 MCG/0.5 ML 100 MCG/0.5 ML 120 MCG/0.5 ML 150 MCG/0.5 ML RIBAVIRIN 200 MG CAPSULES PLUS PEGINTERFERON ALFA-2B POWDER FOR SOLUTION IN REDIPEN ® SINGLE DOSE DELIVERY SYSTEM : _ _ 50 MCG/0.5 ML 80 MCG/0.5 ML 100 MCG/0.5 ML 120 MCG/0.5 ML 150 MCG/0.5 ML ANTIVIRAL AGENT PLUS BIOLOGICAL RESPONSE MODIFIER Merck Canada Inc. 16750 route Transcanadienne Kirkland, Quebec H9H 4M7 Submission Control No: 144506 Date of Approval: March 22, 2011 PEGETRON ® , UNITRON ® and INTRON A ® are registered trademarks of Schering-Plough Ltd., used under license by Schering-Plough Canada Inc. REDIPEN ® is a registered trademark of Schering-Plough Canada Inc. PR PEGETRON ® (RIBAVIRIN + PEGINTERFERON ALFA-2B) PRODUCT MONOGRAPH PAGE 2 OF 76 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION........................................................ 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 DESCRIPTION................................................................................................................... 3 INDICATIONS AND CLINICAL USE............................................................................. 4 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS................................................................................. 5 ADVERSE REACTIONS................................................................................................. 14 DRUG INTERACTIONS ................................................................................................. 25 DOSAGE AND ADMINISTRATION............................................................................. 27 OVERDOSAGE .................................... Read the complete document