Entecavir Sandoz 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:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

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 6000 ; MAGNESIUMSTEARAAT (E 470b) ; TALK (E 553 B) ; 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 6000; MAGNESIUMSTEARAAT (E 470b); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2017-08-03

Bijsluiter

Sandoz B.V.
Page 1/7
Entecavir Sandoz
®
0,5 mg/1 mg, filmomhulde
tabletten
RVG 119703-4
1313-V1
1.3.1.3 Bijsluiter
September 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Entecavir Sandoz
®
0,5 mg, filmomhulde tabletten
Entecavir Sandoz
®
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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[NATIONALLY COMPLETED NAME] TABLETS ARE ANTI-VIRAL MEDICINES, USED TO
TREAT CHRONIC (LONG
TERM) HEPATITIS B
VIRUS
(HBV) INFECTION IN ADULTS.
[Nationally completed name]
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).
[NATIONALLY COMPLETED NAME] TABLETS ARE ALSO USED TO TREAT CHRONIC
(LONG TERM) HBV
INFECTION IN CHILDREN
AND
ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS
. [Nationally
completed name]
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.
[Nationally completed name]
reduces the amount
of
virus in your body, and improves the condition of the
li

Productkenmerken

Sandoz B.V.
Page 1/28
Entecavir Sandoz 0,5 mg/1 mg, filmomhulde tabletten
RVG 119703-4
1311-V1
1.3.1.1 Samenvatting van de Productkenmerken
Februari 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Entecavir Sandoz 0,5 mg, filmomhulde tabletten
Entecavir Sandoz 1 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Nationally completed name] 0.5 mg film-coated tablets
Each film-coated tablet contains 0.5 mg of entecavir (as monohydrate).
Excipient with known effect
Each 0.5 mg film-coated tablet contains 114.4 mg of lactose (as
monohydrate).
[Nationally completed name] 1 mg film-coated tablets
Each film-coated tablet contains 1 mg of entecavir (as
monohydrate).
Excipient with known effect
Each 1 mg film-coated tablet contains 228.9 mg of lactose (as
monohydrate).
For the full list of excipients, see section
6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
[Nationally completed name] 0.5 mg film-coated tablets
White, round, film-coated tablet with debossment on both sides,
“SZ” on one side and “108” on the
other side with diameter approximately 8.0 mm.
[Nationally completed name] 1 mg film-coated tablets
pink, round, film-coated tablet with debossment on both sides,
“SZ” on one side and “109” on the
other side with diameter approximately 10.0 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Entecavir is indicated for the treatment of chronic hepatitis B virus
(HBV) infection (see section
5.1)
in adults
with:
Sandoz B.V.
Page 2/28
Entecavir Sandoz 0,5 mg/1 mg, filmomhulde tabletten
RVG 119703-4
1311-V1
1.3.1.1 Samenvatting van de Productkenmerken
Februari 2021
•
compensated liver disease and evidence of active viral replication,
persistently elevated
s
erum
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 po