VICTRELIS TRIPLE CAPSULE

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

BOCEPREVIR; RIBAVIRIN; PEGINTERFERON ALFA-2B

Saadav alates:

MERCK CANADA INC

ATC kood:

L03AB60

INN (Rahvusvaheline Nimetus):

PEGINTERFERON ALFA-2B, COMBINATIONS

Annus:

200MG; 200MG; 150MCG

Ravimvorm:

CAPSULE

Koostis:

BOCEPREVIR 200MG; RIBAVIRIN 200MG; PEGINTERFERON ALFA-2B 150MCG

Manustamisviis:

ORAL

Ühikuid pakis:

168 BOC CAPS 84/98 RBV CAPS AND 2 REDIPEN

Retsepti tüüp:

Prescription

Terapeutiline ala:

INTERFERONS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0352956004; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2016-09-02

Toote omadused

_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
.........................................................