PEGETRON CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
01-02-2017
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
RIBAVIRIN; PEGINTERFERON ALFA-2B
Available from:
MERCK CANADA INC
ATC code:
L03AB60
INN (International Name):
PEGINTERFERON ALFA-2B, COMBINATIONS
Dosage:
200MG; 150MCG
Pharmaceutical form:
CAPSULE
Composition:
RIBAVIRIN 200MG; PEGINTERFERON ALFA-2B 150MCG
Administration route:
ORAL
Units in package:
2X0.7ML-84CAPS/2X0.7ML-98CAPS
Prescription type:
Prescription
Therapeutic area:
INTERFERONS
Product summary:
Active ingredient group (AIG) number: 0247602005; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2017-04-04
Summary of Product characteristics
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
...............................................
Read the complete document
