PEGETRON CAPSULE

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

RIBAVIRIN; PEGINTERFERON ALFA-2B

Saadav alates:

MERCK CANADA INC

ATC kood:

L03AB60

INN (Rahvusvaheline Nimetus):

PEGINTERFERON ALFA-2B, COMBINATIONS

Annus:

200MG; 150MCG

Ravimvorm:

CAPSULE

Koostis:

RIBAVIRIN 200MG; PEGINTERFERON ALFA-2B 150MCG

Manustamisviis:

ORAL

Ühikuid pakis:

2X0.7ML-84CAPS/2X0.7ML-98CAPS

Retsepti tüüp:

Prescription

Terapeutiline ala:

INTERFERONS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0247602005; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2017-04-04

Toote omadused

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