Entecavir Zentiva 1 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

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

Beschikbaar vanaf:

Alvogen Malta Operations (ROW) Ltd. Malta Life Sciences Park, Building 1, Level 4, Sir Temi Zammit Buildings SGN 3000 SAN GW

ATC-code:

J05AF10

INN (Algemene Internationale Benaming):

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

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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),

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); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYSORBAAT 80 (E 433); TITAANDIOXIDE (E 171);

Autorisatie datum:

2017-06-12

Bijsluiter

ENTECAVIR MONOHYDRATE_film-coated tablet_NL_en_NL-H-3828-001-002_name
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ENTECAVIR ZENTIVA 0.5 MG FILMOMHULDE TABLETTEN
ENTECAVIR ZENTIVA 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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC
(LONG TERM)
HEPATITIS B VIRUS (HBV) INFECTION IN ADULTS.
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).
TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV
INFECTION IN
CHILDREN AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS.
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.
reduces the
amount of virus in your body, and improves the condition of the liver.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE
-
if you are allergic to entecavir or any of the other ingredients of
this medicine (listed in
section 6).

Productkenmerken

ENTECAVIR MONOHYDRATE_film-coated tablet_NL_en_NL-H-3828-001-002_name
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SUMMARY OF PRODUCT CHARACTERISTICS
ENTECAVIR MONOHYDRATE_film-coated tablet_NL_en_NL-H-3828-001-002_name
change_2021_09
1.
NAME OF THE MEDICINAL PRODUCT
Entecavir Zentiva 0.5 mg filmomhulde tabletten
Entecavir Zentiva 1 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Entecavir Zentiva 0.5 mg film-coated tablets
Each tablet contains entecavir monohydrate corresponding to 0.5 mg
entecavir.
Entecavir Zentiva 1 mg film-coated tablets
Each tablet contains entecavir monohydrate corresponding to 1 mg
entecavir.
Excipients with known effect:
Each 0.5 mg film-coated tablet contains 121 mg lactose monohydrate.
Each 1 mg film-coated tablet contains 242 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Entecavir Zentiva 0.5 mg film-coated tablets
White oval shaped tablet with a size of about 10.1 mm x 3.7 mm with
break line on both sides.
The tablet can be divided into equal halves.
Entecavir Zentiva 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 halves.
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