Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
RIBAVIRIN; PEGINTERFERON ALFA-2B
MERCK CANADA INC
L03AB60
PEGINTERFERON ALFA-2B, COMBINATIONS
200MG; 150MCG
CAPSULE
RIBAVIRIN 200MG; PEGINTERFERON ALFA-2B 150MCG
ORAL
2X0.7ML-84CAPS/2X0.7ML-98CAPS
Prescription
INTERFERONS
Active ingredient group (AIG) number: 0247602005; AHFS:
CANCELLED POST MARKET
2017-04-04
PR PEGETRON ® (RIBAVIRIN + PEGINTERFERON ALFA-2B) PRODUCT MONOGRAPH PAGE 1 OF 70 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 150 MCG/0.5 ML RIBAVIRIN 200 MG CAPSULES PLUS _ _ PEGINTERFERON ALFA-2B POWDER FOR SOLUTION IN CLEARCLICK™ SINGLE DOSE DELIVERY SYSTEM:_ _ 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 www.merck.ca Submission Control No: 201233 Date of Approval: February 1, 2017 PR PEGETRON ® (RIBAVIRIN + PEGINTERFERON ALFA-2B) PRODUCT MONOGRAPH PAGE 2 OF 70 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 DESCRIPTION................................................................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS ................................................................................. 5 ADVERSE REACTIONS ................................................................................................. 13 DRUG INTERACTIONS ................................................................................................. 23 DOSAGE AND ADMINISTRATION ............................................................................. 26 OVERDOSAGE ............................................................................................................... 34 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 34 STORAGE AND STABILITY ............................................... Izlasiet visu dokumentu