VICTRELIS TRIPLE CAPSULE

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

BOCEPREVIR; RIBAVIRIN; PEGINTERFERON ALFA-2B

Dostupné s:

MERCK CANADA INC

ATC kód:

L03AB60

INN (Mezinárodní Name):

PEGINTERFERON ALFA-2B, COMBINATIONS

Dávkování:

200MG; 200MG; 80MCG

Léková forma:

CAPSULE

Složení:

BOCEPREVIR 200MG; RIBAVIRIN 200MG; PEGINTERFERON ALFA-2B 80MCG

Podání:

ORAL

Jednotky v balení:

168 BOC CAPS 56 RBV CAPS AND 2 REDIPEN

Druh předpisu:

Prescription

Terapeutické oblasti:

INTERFERONS

Přehled produktů:

Active ingredient group (AIG) number: 0352956001; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2017-01-10

Charakteristika produktu

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