Maviret
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
02-03-2023
Valmisteyhteenveto
(SPC)
02-03-2023
Julkisesta arviointikertomuksesta
(PAR)
28-07-2021
Aktiivinen ainesosa:
glecaprevir, pibrentasvir
Saatavilla:
AbbVie Deutschland GmbH Co. KG
ATC-koodi:
J05AP57
INN (Kansainvälinen yleisnimi):
glecaprevir, pibrentasvir
Terapeuttinen ryhmä:
Antivirals for systemic use
Terapeuttinen alue:
Hepatitis C, Chronic
Käyttöaiheet:
Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older.Maviret coated granules is indicated for the treatment of chronic hepatitis C virus (HCV) infection in children 3 years and older.
Tuoteyhteenveto:
Revision: 22
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2017-07-26
Pakkausseloste
64
B. PACKAGE LEAFLET
65
PACKAGE LEAFLET: INFORMATION FOR THE USER
MAVIRET 100 MG/40 MG FILM-COATED TABLETS
glecaprevir/pibrentasvir
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 Maviret is and what it is used for
2.
What you need to know before you take Maviret
3.
How to take Maviret
4.
Possible side effects
5.
How to store Maviret
6.
Contents of the pack and other information
1.
WHAT MAVIRET IS AND WHAT IT IS USED FOR
Maviret is an antiviral medicine used to treat adults and children 3
years and older with long-term
(‘chronic’) hepatitis C. This is an infectious disease that
affects the liver, caused by the hepatitis C
virus. Maviret contains the active substances glecaprevir and
pibrentasvir.
Maviret works by stopping the hepatitis C virus from multiplying and
infecting new cells. This allows
the infection to be eliminated from the body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAVIRET
DO NOT TAKE MAVIRET IF:
you are allergic to glecaprevir, pibrentasvir or any of the other
ingredients of this medicine
(listed in section 6).
you have severe liver problems other than from hepatitis C.
you are taking the following medicines:
atazanavir (for HIV infection)
atorvastatin or simvastatin (to lower blood cholesterol)
carbamazepine, phenobarbital, phenytoin, primidone (normally used for
epilepsy)
dabigatran etexilate (to prevent blood clots)
ethinyl oestradiol-containing medicines (such as contraception
medicines, including
vaginal rings, transdermal patch
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Maviret 100 mg/40 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg glecaprevir and 40 mg
pibrentasvir.
Excipient with known effect
Each film-coated tablet contains 7.48 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Pink, oblong, biconvex, film-coated tablet of dimensions 18.8 mm x
10.0 mm, debossed on one side
with ‘NXT’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Maviret is indicated for the treatment of chronic hepatitis C virus
(HCV) infection in adults and
children aged 3 years and older (see sections 4.2, 4.4. and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Maviret treatment should be initiated and monitored by a physician
experienced in the management of
patients with HCV infection.
Posology
_Adults, adolescents aged 12 years and older, or children weighing at
least 45 kg_
The recommended dose of Maviret is 300 mg/120 mg (three 100 mg/40 mg
tablets), taken orally, once
daily at the same time with food (see section 5.2).
The recommended Maviret treatment durations for HCV genotype 1, 2, 3,
4, 5, or 6 infected patients
with compensated liver disease (with or without cirrhosis) are
provided in Table 1 and Table 2.
TABLE 1: RECOMMENDED MAVIRET TREATMENT DURATION FOR PATIENTS WITHOUT
PRIOR HCV THERAPY
GENOTYPE
RECOMMENDED TREATMENT DURATION
NO CIRRHOSIS
CIRRHOSIS
GT 1, 2, 3, 4, 5, 6
8 weeks
8 weeks
3
TABLE 2: RECOMMENDED MAVIRET TREATMENT DURATION FOR PATIENTS WHO
FAILED PRIOR THERAPY WITH
PEG-IFN + RIBAVIRIN +/- SOFOSBUVIR, OR SOFOSBUVIR + RIBAVIRIN
GENOTYPE
RECOMMENDED TREATMENT DURATION
NO CIRRHOSIS
CIRRHOSIS
GT 1, 2, 4-6
8 weeks
12 weeks
GT 3
16 weeks
16 weeks
For patients who failed prior therapy with an NS3/4A- and/or an NS5A
inhibitor, see section 4.4.
_Missed dose_
In case a dose of Maviret is missed, the prescribed dose can be taken
within 18 hours after the time it
w
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