Zepatier
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
07-07-2022
Charakterystyka produktu
(SPC)
07-07-2022
Sprawozdanie z oceny publicznego
(PAR)
09-02-2022
Składnik aktywny:
elbasvir, grazoprevir
Dostępny od:
Merck Sharp & Dohme B.V.
Kod ATC:
J05AP54
INN (International Nazwa):
elbasvir, grazoprevir
Grupa terapeutyczna:
Direct acting antivirals, Antivirals for systemic use, , Antivirals for treatment of HCV infections
Dziedzina terapeutyczna:
Hepatitis C, Chronic
Wskazania:
ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.,
Podsumowanie produktu:
Revision: 12
Status autoryzacji:
Authorised
Data autoryzacji:
2016-07-22
Ulotka dla pacjenta
45
B. PACKAGE LEAFLET
46
PACKAGE LEAF
LET: IN
FORMATION FOR THE U
SER
ZEPATIER 50 MG/100 MG FILM-
COATED TABLETS
elbasvir/grazoprevir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING TH
IS MEDICINE B
ECAUSE IT CONTAINS
IMPORTANT INFORMATI
ON FOR YOU.
Keep th
is leaflet. You may
need to read it again.
If you have
any fur
ther questions, ask
your doctor or pharmacist.
This
medicine has been pres
cribed for you only. Do not pass it on to others.
It may harm
them,
even if their signs of illness a
re the same a
s yours.
If you get any s
ide effects, talk to your doctor or p
harmaci
st. This includes a
ny p
ossible side
effects not lis
ted in this leaflet. Se
e section 4.
WHAT IS IN THIS LEAFLET
1.
What ZEPATIER is and what it is used for
2.
What you need
to know befo
re you take
ZEPATIER
3.
How to take
ZEPATIER
4.
Possible side
effects
5.
How to store
ZEPATIER
6.
Contents of the pack
and other information
1.
WHAT ZEPATIER IS AND WHAT IT IS USED FOR
WHAT
ZEPATIER IS
ZEPATIER is an antiviral medicine that contains the acti
ve substances elbas
vir and grazoprevir.
WHAT
ZEPATIER IS USED FOR
ZEPATIER
is used to treat long-term hepatitis C
infection in adult
s and children aged 12 years and
older who weigh at least 30 kilograms.
HOW ZEPATIER WORKS
Hepatitis C is a virus that infects the liver. The ac
tive substances in the medi
cine work together by
blocking two different pro
teins that the hepatitis C virus needs to grow and reproduce. This
allows the
infection to be permanently removed from the body.
ZEPATIER is sometimes taken with ano
ther medicine
, ribavirin.
It is very imp
ortant that yo
u also read the leaflets for the o
ther medicines
that you will be t
aking with
ZEPATIER. If you have any questions about your medicines, please ask
your doctor or pharmacist.
2.
WHAT YOU NEED TO KNOW
BEFORE YOU TA
KE
ZEPATIER
DO NOT TAKE
ZEPATIER IF
:
you
are allergic to
elbasvir, grazopre
vir or any of
the other ingredien
ts of this medicine (listed in
section 6)
you have certain moderate or severe
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACT
ERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ZEPATIER
50 mg/100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COM
POSITION
Each film-
coated tablet con
tains 50
mg elbasvir and
100 mg grazoprevir.
Excipie
nts with known effect
Each film-coated
tablet contains 87.02
mg of lactose
(as monohydrate)
and 69.85 mg of sodium.
For the fu
ll list of excipients, see section
6.1.
3.
PHA
RMACEUT
ICAL FORM
Film-coated tablet.
Beige, oval tablet of dimensions 21 mm x 10
mm debossed with “770” on one side an
d plain on the
other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICAT
IONS
ZEPATIER i
s indicated for the treatment of chro
nic hepatitis C (C
HC) in adult
and paediatric patients
12 years of age and older who weigh at least 30 kg
(see sections
4.2, 4.4 and 5.1).
For hepatitis C virus (
HCV) genotype
-
specific activity
see sections 4.4 and 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ZEPATIER
treatment should b
e initiated and monitored
by a physician experienced in the
management of patients with
CHC.
Posology
The recommended dose is
one tablet once daily.
Recommended reg
imens and treatm
ent durations are provided in Table
1 below (see section
s 4.4
and 5.1):
3
TABLE
1: RECOMMENDED ZEPA
TIER THERAPY FOR TREATMENT OF
CHRONIC HEPATITIS C INFECTION IN
PATIENTS WITH OR WITHOUT C
OMPENSATED C
IRRHOSIS (CHILD
-
PUGH A ONLY)
HCV GENOTYP
E
TREATMENT AND DURATION
1a
ZEPATIER
for 12 weeks
ZEPATIER
for 16
weeks plus r
ibavirin
A
should be consid
ered in
patients with baseline
HCV RNA level
>800,000 IU/
mL and/or the
presence of specific NS5A polymorphism
s causing at least a 5
-fold
reduction in activit
y of elbasvir to minimi
s
e the risk of treatment failure
(see section 5.1).
1b
ZEPATIER
for 12 weeks
4
ZEPATIER for 12 weeks
ZEPATIER
for 16 weeks plus ribavirin
A
should be considered in
pa
tients with baseline
HCV RNA level
>800,000 IU/mL to minimise
the risk of treatment failure (see section 5.1)
.
A
In the adult clinical studies, the dose of ribavirin was weight-based
(< 66 kg
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