Incivo

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

telaprevir

Saatavilla:

Janssen-Cilag International N.V.

ATC-koodi:

J05AE

INN (Kansainvälinen yleisnimi):

telaprevir

Terapeuttinen ryhmä:

Antivirals for systemic use

Terapeuttinen alue:

Hepatitis C, Chronic

Käyttöaiheet:

Incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis):who are treatment naïve;who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.

Tuoteyhteenveto:

Revision: 19

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2011-09-19

Pakkausseloste

54
B. PACKAGE LEAFLET
Medicinal product no longer authorised
55
PACKAGE LEAFLET: INFORMATION FOR THE USER
INCIVO 375 MG FILM-COATED TABLETS
telaprevir
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 only. 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 INCIVO is and what it is used for
2.
What you need to know before you take INCIVO
3.
How to take INCIVO
4.
Possible side effects
5.
How to store INCIVO
6.
Contents of the pack and other information
1.
WHAT INCIVO IS AND WHAT IT IS USED FOR
INCIVO acts against the virus that causes hepatitis C infection and is
used to treat chronic hepatitis C
infection in adult patients (aged 18–65 years) in combination with
peginterferon alfa and ribavirin.
INCIVO contains a substance called telaprevir and belongs to a group
of medicines called ‘NS3-4A
protease inhibitors’. The NS3-4A protease inhibitor reduces the
amount of hepatitis C virus in your
body. INCIVO must not be taken alone and must be taken in combination
with peginterferon alfa and
ribavirin to be sure your treatment works. INCIVO can be used for
patients with chronic hepatitis C
infection who have never been treated before or can be used in
patients with chronic hepatitis C
infection who have been treated previously with an interferon-based
regimen.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE INCIVO
DO NOT TAKE INCIVO if yo

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
INCIVO 375 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 375 mg of telaprevir.
Excipient: 2.3 mg of sodium per film-coated tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow caplet shaped tablets of approximately 20 mm in length, marked
with “T375” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INCIVO, in combination with peginterferon alfa and ribavirin, is
indicated for the treatment of
genotype 1 chronic hepatitis C in adult patients with compensated
liver disease (including cirrhosis):
-
who are treatment-naïve;
-
who have previously been treated with interferon alfa (pegylated or
non-pegylated) alone or in
combination with ribavirin, including relapsers, partial responders
and null responders (see
sections 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with INCIVO should be initiated and monitored by a physician
experienced in the
management of chronic hepatitis C.
Posology
INCIVO, 1,125 mg (three 375 mg film-coated tablets) should be taken
orally twice daily (b.i.d.) with
food. Alternatively, 750 mg (two 375 mg tablets) can be taken orally
every 8 hours (q8h) with food.
The total daily dose is 6 tablets (2,250 mg). Taking INCIVO without
food or without regard to the
dosing interval may result in decreased plasma concentrations of
telaprevir which could reduce the
therapeutic effect of INCIVO.
INCIVO should be administered in conjunction with ribavirin and either
peginterferon alfa-2a or -2b.
Please consult sections 4.4 and 5.1 regarding the selection of
peginterferon alfa-2a or -2b. For spe