Entecavir Krka 1 mg filmomhulde tabletten

Country: Netherlands

Language: Dutch

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

Active ingredient:

ENTECAVIR 1-WATER 1,06 mg/stuk SAMENSTELLING overeenkomend met ; ENTECAVIR 1 mg/stuk

Available from:

Krka d.d., Novo mesto Smarjeska cesta 6 8501 NOVO MESTO (SLOVENIË)

ATC code:

J05AF10

INN (International Name):

ENTECAVIR 1-WATER 1,06 mg/stuk SAMENSTELLING overeenkomend met ; ENTECAVIR 1 mg/stuk

Pharmaceutical form:

Filmomhulde tablet

Composition:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; TITAANDIOXIDE (E 171),

Administration route:

Oraal gebruik

Therapeutic area:

Entecavir

Product summary:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); TITAANDIOXIDE (E 171);

Authorization date:

1900-01-01

Patient Information leaflet

1.3.1
Entecavir
SPC, Labeling and Package Leaflet
NL-Netherlands
PI_Text009649_2
- Updated:
Page 27 of 31
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENTECAVIR KRKA 0,5 MG FILMOMHULDE TABLETTEN
ENTECAVIR KRKA 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 Krka is and what it is used for
2.
What you need to know before you take Entecavir Krka
3.
How to take Entecavir Krka
4.
Possible side effects
5.
How to store Entecavir Krka
6.
Contents of the pack and other information
1.
WHAT ENTECAVIR KRKA IS AND WHAT IT IS USED FOR
ENTECAVIR KRKA TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC
(LONG TERM) HEPATITIS B VIRUS
(HBV) INFECTION IN ADULTS.
Entecavir Krka 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 KRKA TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV
INFECTION IN CHILDREN AND
ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS.
Entecavir Krka 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 Krka 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 KRKA
DO NOT TAKE ENTECAVIR KRKA:
-
IF YOU ARE ALLERGIC (HYPERSENSITIVE)
to entecavir or any of the other ingredients of thi

Summary of Product characteristics

1.3.1
Entecavir
SPC, Labeling and Package Leaflet
NL-Netherlands
PI_Text038430_1
- Updated:
Page 1 of 20
1.
NAME OF THE MEDICINAL PRODUCT
Entecavir Krka 0,5 mg filmomhulde tabletten
Entecavir Krka 1 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.5 mg entecavir (as monohydrate).
Each film-coated tablet contains 1 mg entecavir (as monohydrate).
Excipient(s) with known effect
Each 0.5 mg film-coated tablet contains 120.5 mg lactose monohydrate.
Each 1 mg film-coated tablet contains 241.0 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White triangular shaped film coated tablets debossed 'A' on one side
and '88' on the other side of 8.7 x
8.4 mm.
Pink triangular shaped film coated tablets debossed 'A' on one side
and '89' on the other side of 10.9 x
10.5 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULT INDICATION
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.
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 se