Entecavir Vocate 1 mg, filmomhulde tabletten

Land: Nederländerna

Språk: nederländska

Källa: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktiva substanser:

ENTECAVIR 1-WATER 1 mg/stuk SAMENSTELLING overeenkomend met ; ENTECAVIR 0,94 mg/stuk

Tillgänglig från:

Vocate Pharmaceuticals SA 150 Gounari street 16674 GLYFADA (GRIEKENLAND)

ATC-kod:

J05AF10

INN (International namn):

ENTECAVIR 1-WATER 1 mg/stuk SAMENSTELLING overeenkomend met ; ENTECAVIR 0,94 mg/stuk

Läkemedelsform:

Filmomhulde tablet

Sammansättning:

CALCIUMCARBONAAT (E 170) ; CARMELLOSE NATRIUM (E 466) ; CITROENZUUR 1-WATER (E 330) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 400 ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; POLYSACCHARIDEN VAN SOJA ; TITAANDIOXIDE (E 171), CALCIUMCARBONAAT (E 170) ; CARMELLOSE NATRIUM (E 466) ; CITROENZUUR 1-WATER (E 330) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 400 ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; POLYSACCHARIDEN VAN SOJA ; TITAANDIOXIDE (E 171),

Administreringssätt:

Oraal gebruik

Terapiområde:

Entecavir

Produktsammanfattning:

Hulpstoffen: CALCIUMCARBONAAT (E 170); CARMELLOSE NATRIUM (E 466); CITROENZUUR 1-WATER (E 330); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE ROOD (E 172); MACROGOL 400; MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMSTEARYLFUMARAAT; POLYSACCHARIDEN VAN SOJA; TITAANDIOXIDE (E 171);

Tillstånd datum:

2018-04-12

Bipacksedel

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENTECAVIR VOCATE 0,5 MG, FILMOMHULDE TABLETTEN
ENTECAVIR VOCATE 1 MG, FILMOMHULDE TABLETTEN
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 Vocate is and what it is used for
2.
What you need to know before you take Entecavir Vocate
3.
How to take Entecavir Vocate
4.
Possible side effects
5.
How to store Entecavir Vocate
6.
Contents of the pack and other information
1.
WHAT ENTECAVIR VOCATE IS AND WHAT IT IS USED FOR
ENTECAVIR VOCATE TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT
CHRONIC (LONG TERM) HEPATITIS B
VIRUS (HBV) INFECTION IN ADULTS.
Entecavir Vocate 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 VOCATE TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM)
HBV INFECTION IN CHILDREN
AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS.
ENTECAVIR VOCATE
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 Vocate 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 VOCATE
DO NOT TAKE ENTECAVIR VOCATE
•
IF YOU ARE ALLERGIC (HYPERSENSITIVE)
to entecavir or any of the other ingredients of this medicine
(listed in section 6).
WARNING AN

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Entecavir Vocate 0,5 mg, filmomhulde tabletten
Entecavir Vocate 1 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Entecavir Vocate 0.5 mg film-coated tablets
Each tablet contains 0.5 mg entecavir (as monohydrate).
Entecavir Vocate 1 mg film-coated tablets
Each tablet contains 1 mg entecavir (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Entecavir Vocate 0.5 mg film-coated tablets
White to off white, triangle shaped, approx. 8.7 x 8.40 mm, biconvex
film- coated tablets debossed
with ‘J' on one
side and ‘110’ on other side.
Entecavir Vocate 1 mg film-coated tablets
Pink, triangle shaped, approx. 11.0 x 10.60 mm, biconvex film - coated
tablets debossed with 'J' on
one side and '111' on
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Entecavir Vocate 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.
Entecavir Vocate 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, and 5.1.
4.2
POSOLOGY AND