PEGETRON CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

RIBAVIRIN; PEGINTERFERON ALFA-2B

Disponible depuis:

MERCK CANADA INC

Code ATC:

L03AB60

DCI (Dénomination commune internationale):

PEGINTERFERON ALFA-2B, COMBINATIONS

Dosage:

200MG; 120MCG

forme pharmaceutique:

CAPSULE

Composition:

RIBAVIRIN 200MG; PEGINTERFERON ALFA-2B 120MCG

Mode d'administration:

ORAL

Unités en paquet:

2X0.7ML-35CAPS

Type d'ordonnance:

Prescription

Domaine thérapeutique:

INTERFERONS

Descriptif du produit:

Active ingredient group (AIG) number: 0247602004; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2013-01-23

Résumé des caractéristiques du produit

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
....................................