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:

2X0.675ML-70 CAPS

Type d'ordonnance:

Prescription

Domaine thérapeutique:

INTERFERONS

Descriptif du produit:

Active ingredient group (AIG) number: 0247602008; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2017-10-05

Résumé des caractéristiques du produit

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