VICTRELIS TRIPLE CAPSULE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

BOCEPREVIR; RIBAVIRIN; PEGINTERFERON ALFA-2B

Saatavilla:

MERCK CANADA INC

ATC-koodi:

L03AB60

INN (Kansainvälinen yleisnimi):

PEGINTERFERON ALFA-2B, COMBINATIONS

Annos:

200MG; 200MG; 120MCG

Lääkemuoto:

CAPSULE

Koostumus:

BOCEPREVIR 200MG; RIBAVIRIN 200MG; PEGINTERFERON ALFA-2B 120MCG

Antoreitti:

ORAL

Kpl paketissa:

168 BOC CAPS 70 RBV CAPS AND 2 REDIPEN

Prescription tyyppi:

Prescription

Terapeuttinen alue:

INTERFERONS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0352956003; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2016-09-02

Valmisteyhteenveto

_VICTRELIS TRIPLE_
®
_ (boceprevir, ribavirin plus peginterferon alfa-2b) _
_ Page 1 of 97 _
_ _
PRODUCT MONOGRAPH
VICTRELIS TRIPLE
®
VICTRELIS
®
boceprevir capsules, 200 mg
Hepatitis C Virus (HCV) Protease Inhibitor (PI)
PLUS
PEGETRON
®
ribavirin capsules, 200 mg
Antiviral Agent
plus
peginterferon alfa-2b powder for solution in CLEARCLICK
TM
single dose delivery system:_ _
80 mcg/0.5 mL
100 mcg/0.5 mL
120 mcg/0.5 mL
150 mcg/0.5 mL, when reconstituted
Biological Response Modifier
NOTE: THESE PRODUCTS ARE INTENDED ONLY FOR USE AS DESCRIBED. THE
INDIVIDUAL
PRODUCTS CONTAINED IN VICTRELIS TRIPLE
® SHOULD NOT BE USED ALONE OR IN
COMBINATION FOR OTHER PURPOSES. THE INFORMATION DESCRIBED IN THIS
PRODUCT
MONOGRAPH CONCERNS ONLY THE USE OF THESE PRODUCTS. FOR INFORMATION ON
THE
USE OF THE INDIVIDUAL COMPONENTS WHEN DISPENSED AS INDIVIDUAL
MEDICATIONS
OUTSIDE THIS COMBINED USE FOR THE TREATMENT OF CHRONIC HEPATITIS C
(CHC), THE
RESPECTIVE PRODUCT MONOGRAPHS FOR THESE PRODUCTS SHOULD BE CONSULTED.
MERCK CANADA INC.
16750, route Transcanadienne
Kirkland, QC Canada H9H 4M7
http://www.merck.ca
SUBMISSION CONTROL NO: 185622
Date of Revision:
September 11, 2015
_VICTRELIS TRIPLE_
®
_ (boceprevir, ribavirin plus peginterferon alfa-2b) _
_ Page 2 of 97 _
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
....................................................................................................
4
ADVERSE REACTIONS
...................................................................................................
18
DRUG INTERACTIONS
...................................................................................................
28
DOSAGE AND ADMINISTRATION
.........................................................