Entecavir Accord

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Entecavir

Διαθέσιμο από:

Accord Healthcare S.L.U.

Φαρμακολογική κατηγορία (ATC):

J05AF10

INN (Διεθνής Όνομα):

entecavir

Θεραπευτική ομάδα:

Antivirals for systemic use

Θεραπευτική περιοχή:

Hepatitis B, Chronic

Θεραπευτικές ενδείξεις:

Entecavir Accord 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. Entecavir Accord is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to

Περίληψη προϊόντος:

Revision: 5

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2017-09-25

Φύλλο οδηγιών χρήσης

37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENTECAVIR ACCORD 0.5 MG FILM-COATED TABLETS
ENTECAVIR ACCORD 1 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 Entecavir Accord is and what it is used for
2.
What you need to know before you take Entecavir Accord
3.
How to take Entecavir Accord
4.
Possible side effects
5.
How to store Entecavir Accord
6.
Contents of the pack and other information
1.
WHAT ENTECAVIR ACCORD IS AND WHAT IT IS USED FOR
ENTECAVIR ACCORD TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT
CHRONIC (LONG TERM) HEPATITIS B
VIRUS (HBV) INFECTION IN ADULTS.
Entecavir Accord 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).
ENTECAVIR ACCORD TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM)
HBV INFECTION IN CHILDREN
AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS.
Entecavir Accord 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.
Entecavir Accord reduces the amount
of virus in your body, and improves the condition of the liver.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENTECAVIR ACCORD
DO NOT TAKE ENTECAVIR ACCORD
-
IF YOU ARE ALLERGIC (HYPERSENSITIVE)
to entecavir or any of the other ingredients of this medicine
(listed in section 6).
WARNING AND PRECAUTIONS

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Entecavir Accord 0.5 mg film-coated tablets
Entecavir Accord 1 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Entecavir Accord 0.5 mg film-coated tablets
Each tablet contains entecavir monohydrate equivalent to 0.5 mg
entecavir .
Entecavir Accord 1 mg film-coated tablets
Each tablet contains entecavir monohydrate equivalent to 1 mg
entecavir.
Excipients with known effect
Each 0.5 mg film-coated tablet contains 26 mg soy polysaccharides.
Each 1 mg film-coated tablet contains 52 mg soy polysaccharides.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Entecavir Accord 0.5 mg film-coated tablets
White to off white, triangle shaped, biconvex film-coated tablets
debossed with ‘J' on one side and
‘110’ on other side.
Dimension: Length 8.70 mm ± 0.20 mm, width 8.40 mm ± 0.20 mm and
thickness 3.40 mm ±
0.30 mm.
Entecavir Accord 1 mg film-coated tablets
Pink, triangle shaped, biconvex film-coated tablets debossed with 'J'
on one side and '111' on other
side.
Dimension: Length 11.00 mm ± 0.20 mm, width 10.60 mm ± 0.20 mm and
thickness 4.20 mm ±
0.30 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Entecavir Accord 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)
3
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.
Entecavir Accord is also indicated for the treatment of chronic HBV
infection in nucleoside naive
paediatric