PEGETRON CAPSULE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

RIBAVIRIN; PEGINTERFERON ALFA-2B

Disponibil de la:

MERCK CANADA INC

Codul ATC:

L03AB60

INN (nume internaţional):

PEGINTERFERON ALFA-2B, COMBINATIONS

Dozare:

200MG; 100MCG

Forma farmaceutică:

CAPSULE

Compoziție:

RIBAVIRIN 200MG; PEGINTERFERON ALFA-2B 100MCG

Calea de administrare:

ORAL

Unități în pachet:

2X0.675ML-56CAPS

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

INTERFERONS

Rezumat produs:

Active ingredient group (AIG) number: 0247602001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2017-10-05

Caracteristicilor produsului

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