Victrelis

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

Boceprevir

Saadav alates:

Merck Sharp Dohme Ltd

ATC kood:

J05AE

INN (Rahvusvaheline Nimetus):

boceprevir

Terapeutiline rühm:

Antivirals for systemic use

Terapeutiline ala:

Hepatitis C, Chronic

Näidustused:

Victrelis is indicated for the treatment of chronic hepatitis-C (CHC) genotype-1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

Toote kokkuvõte:

Revision: 22

Volitamisolek:

Withdrawn

Loa andmise kuupäev:

2011-07-18

Infovoldik

51
B. PACKAGE LEAFLET
Medicinal product no longer authorised
52
PACKAGE LEAFLET: INFORMATION FOR THE USER
VICTRELIS 200 MG HARD CAPSULES
boceprevir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Victrelis is and what it is used for
2.
What you need to know before you take Victrelis
3.
How to take Victrelis
4.
Possible side effects
5.
How to store Victrelis
6.
Contents of the pack and other information
1.
WHAT VICTRELIS IS AND WHAT IT IS USED FOR
WHAT VICTRELIS IS
Victrelis contains the active ingredient boceprevir which helps to
fight against hepatitis C infection by
stopping the virus multiplying. Victrelis must always be used together
with two other medicines.
These are called peginterferon alfa and ribavirin. Victrelis must not
be used by itself.
WHAT VICTRELIS IS USED FOR
Victrelis, in combination with peginterferon alfa and ribavirin, is
used for chronic hepatitis C virus
infection in adults (also called HCV infection).
Victrelis may be used in adults who are previously untreated for HCV
infection or who have
previously used medicines called ‘interferons’ and ‘pegylated
interferons’.
HOW VICTRELIS WORKS
Victrelis inhibits the direct replication of the virus and contributes
in this way to lowering the amount
of hepatitis C virus in your body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VICTRELIS
DO NOT TAKE VICTRELIS IN COMBINATION WITH PEGINTERFERON ALFA AND
RIBAVIRIN IF YOU:

are ALLERGIC to boceprevir or any of the other ingredients of this
medicine (listed in section 6)

a

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Victrelis 200 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 200 mg of boceprevir.
Excipient with known effect
Each capsule contains 56 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Each capsule has a yellowish-brown, opaque cap with an "MSD" logo
imprinted in red ink and off-
white, opaque body with the code "314" imprinted in red ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Victrelis is indicated for the treatment of chronic hepatitis C (CHC)
genotype 1 infection, in
combination with peginterferon alfa and ribavirin, in adult patients
with compensated liver disease
who are previously untreated or who have failed previous therapy (see
sections 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Victrelis should be initiated and monitored by a
physician experienced in the
management of chronic hepatitis C.
Posology
Victrelis must be administered in combination with peginterferon alfa
and ribavirin. The Summary of
Product Characteristics of peginterferon alfa and ribavirin (PR) must
be consulted prior to initiation of
therapy with Victrelis.
The recommended dose of Victrelis is 800 mg administered orally three
times daily (TID) with food
(a meal or light snack). Maximum daily dose of Victrelis is 2,400 mg.
Administration without food
could be associated with a net loss of efficacy due to sub-optimal
exposure.
_Patients without cirrhosis who are previously untreated or who have
failed previous therapy _
The following dosing recommendations differ for some subgroups from
the dosing studied in the
Phase 3 trials (see section 5.1).
Medicinal product no longer authorised
3
Table 1
Duration of therapy using Response-Guided Therapy (RGT) guidelines in
patients without cirrhosis
who are previously untreated or who have failed previous therapy to
interferon and ribavir