Entecavir Klinge 1 mg filmomhulde tabletten

Land: Niederlande

Sprache: Niederländisch

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

Wirkstoff:

ENTECAVIR 1-WATER SAMENSTELLING overeenkomend met ; ENTECAVIR

Verfügbar ab:

Klinge Pharma GmbH

ATC-Code:

J05AF10

INN (Internationale Bezeichnung):

ENTECAVIR 1-WATER COMPOSITION corresponding to ; ENTECAVIR

Darreichungsform:

Filmomhulde tablet

Zusammensetzung:

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) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171),

Verabreichungsweg:

Oraal gebruik

Therapiebereich:

Entecavir

Produktbesonderheiten:

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); MAÏSZETMEEL, GEPREGELATINEERD; POLYSORBAAT 80 (E 433); TITAANDIOXIDE (E 171);

Berechtigungsdatum:

2017-04-20

Gebrauchsinformation

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

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Entecavir Klinge 0,5 mg filmomhulde tabletten
Entecavir Klinge 1 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Entecavir Klinge 0.5 mg film-coated tablets
Each tablet contains 0.5 mg entecavir (as monohydrate).
Entecavir Klinge 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).
Entecavir Klinge 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.
Entecavir Klinge 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 initiate
treatm