Baraclude

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Entecavir

Saatavilla:

Bristol-Myers Squibb Pharma EEIG

ATC-koodi:

J05AF10

INN (Kansainvälinen yleisnimi):

entecavir

Terapeuttinen ryhmä:

Antivirals for systemic use

Terapeuttinen alue:

Hepatitis B, Chronic

Käyttöaiheet:

Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis;decompensated liver disease.For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.

Tuoteyhteenveto:

Revision: 27

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2006-06-26

Pakkausseloste

54
B. PACKAGE LEAFLET
55
PACKAGE LEAFLET: INFORMATION FOR THE USER
BARACLUDE 0.5 MG FILM-COATED TABLETS
Entecavir
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 Baraclude is and what it is used for
2.
What you need to know before you take Baraclude
3.
How to take Baraclude
4.
Possible side effects
5.
How to store Baraclude
6.
Contents of the pack and other information
1.
WHAT BARACLUDE IS AND WHAT IT IS USED FOR
BARACLUDE TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC
(LONG TERM) HEPATITIS B VIRUS
(HBV) INFECTION IN ADULTS.
Baraclude can be used in people whose liver is damaged but still
functions
properly (compensated liver disease) and in people whose liver is
damaged and does not function
properly (decompensated liver disease).
BARACLUDE TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV
INFECTION IN CHILDREN AND
ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS.
Baraclude can be used in children whose liver is
damaged but still functions properly (compensated liver disease).
Infection by the hepatitis B virus can lead to damage to the liver.
Baraclude reduces the amount of
virus in your body, and improves the condition of the liver.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BARACLUDE
DO NOT TAKE BARACLUDE

IF YOU ARE ALLERGIC (HYPERSENSITIVE)
to entecavir or any of the other ingredients of this medicine
(listed in section 6).
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Baraclude

IF YOU HAVE EVER HAD PROBLEMS WITH YOUR KIDNEYS
, tell your d

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Baraclude 0.5 mg film-coated tablets
Baraclude 1 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Baraclude 0.5 mg film-coated tablets
Each tablet contains 0.5 mg entecavir (as monohydrate).
Baraclude 1 mg film-coated tablets
Each tablet contains 1 mg entecavir (as monohydrate).
Excipients with known effect
Each 0.5 mg film-coated tablet contains 120.5 mg lactose.
Each 1 mg film-coated tablet contains 241 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Baraclude 0.5 mg film-coated tablets
White to off-white and triangular-shaped tablet with “BMS”
debossed on one side and “1611” on the
other.
Baraclude 1 mg film-coated tablets
Pink and triangular-shaped tablet with “BMS” debossed on one side
and “1612” on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Baraclude is indicated for the treatment of chronic hepatitis B virus
(HBV) infection (see section 5.1)
in adults with:

compensated liver disease and evidence of active viral replication,
persistently elevated serum
alanine aminotransferase (ALT) levels and histological evidence of
active inflammation and/or
fibrosis.

decompensated liver disease (see section 4.4)
For both compensated and decompensated liver disease, this indication
is based on clinical trial data in
nucleoside naive patients with HBeAg positive and HBeAg negative HBV
infection. With respect to
patients with lamivudine-refractory hepatitis B, see sections 4.2, 4.4
and 5.1.
Baraclude is also indicated for the treatment of chronic HBV infection
in nucleoside naive paediatric
patients from 2 to < 18 years of age with compensated liver disease
who have evidence of active viral
replication and persistently elevated serum ALT levels, or
histological evidence of moderate to severe
inflammation and/or fibrosis. With respect to the decision to initiate
treatment in paediatric patients,
see sections 4.2, 4.4, an