Entecavir ALIUD PHARMA 0,5 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ENTECAVIR 1-WATER SAMENSTELLING overeenkomend met ; ENTECAVIR

Beschikbaar vanaf:

Aliud Pharma GmbH & Co. KG Gottlieb-Daimler-Strasse 19 89150 LAICHINGEN (DUITSLAND)

ATC-code:

J05AF10

INN (Algemene Internationale Benaming):

ENTECAVIR 1-WATER COMPOSITION corresponding to ; ENTECAVIR

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Entecavir

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYSORBAAT 80 (E 433); TITAANDIOXIDE (E 171);

Autorisatie datum:

2017-04-20

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
ENTECAVIR ALIUD PHARMA GMBH 0,5 MG, FILMOMHULDE TABLETTEN
ENTECAVIR ALIUD PHARMA GMBH 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 ALIUD PHARMA GmbH is and what it is used for
2.
What you need to know before you take Entecavir ALIUD PHARMA GmbH
3.
How to take Entecavir ALIUD PHARMA GmbH
4.
Possible side effects
5.
How to store Entecavir ALIUD PHARMA GmbH
6.
Contents of the pack and other information
1.
WHAT ENTECAVIR ALIUD PHARMA GMBH IS AND WHAT IT IS USED FOR
ENTECAVIR ALIUD PHARMA GMBH TABLETS ARE ANTI-VIRAL MEDICINES, USED TO
TREAT CHRONIC
(LONG TERM) HEPATITIS B VIRUS (HBV) INFECTION IN ADULTS.
Entecavir ALIUD PHARMA GmbH 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 ALIUD PHARMA GMBH TABLETS ARE ALSO USED TO TREAT CHRONIC
(LONG TERM)
HBV INFECTION IN CHILDREN AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18
YEARS.
Entecavir ALIUD PHARMA GmbH 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 ALIUD PHARMA
GmbH 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 ALIUD PHARMA GMBH
DO NOT TAKE ENTECAVIR ALIUD PHARMA GMBH
-
if you are a

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Entecavir ALIUD PHARMA GmbH 0,5 mg, filmomhulde tabletten
Entecavir ALIUD PHARMA GmbH 1 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
0.5 mg film-coated tablets
Each tablet contains 0.5 mg entecavir (as monohydrate).
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 120.97 mg lactose monohydrate.
Each 1 mg film-coated tablet contains 241.94 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
0.5 mg film-coated tablets
White oval shaped tablet with a size of about10.1 mm x 3.7 mm with
break line on both sides.
1 mg film-coated tablets
Pink oval shaped tablet with a size of about 12.8 mm x 4.8 mm with
break line on both sides.
The
tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
ADULT INDICATION
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.
PAEDIATRIC POPULATION
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