Vosevi

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Sofosbuvir, velpatasvir, voxilaprevi

Saatavilla:

Gilead Sciences Ireland UC

ATC-koodi:

J05A

INN (Kansainvälinen yleisnimi):

sofosbuvir, velpatasvir, voxilaprevi

Terapeuttinen ryhmä:

Antivirals for systemic use

Terapeuttinen alue:

Hepatitis C, Chronic

Käyttöaiheet:

Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged 12 years and older and weighing at least 30 kg. (see sections 4.2, 4.4 and 5.1).

Tuoteyhteenveto:

Revision: 16

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2017-07-26

Pakkausseloste

43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE USER
VOSEVI 400 MG/100 MG/100 MG FILM-COATED TABLETS
VOSEVI 200 MG/50 MG/50 MG FILM-COATED TABLETS
sofosbuvir/velpatasvir/voxilaprevir
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 Vosevi is and what it is used for
2.
What you need to know before you take Vosevi
3.
How to take Vosevi
4.
Possible side effects
5.
How to store Vosevi
6.
Contents of the pack and other information
IF VOSEVI HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL THE
INFORMATION IN THIS LEAFLET IS
ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD”
INSTEAD OF “YOU”).
1.
WHAT VOSEVI IS AND WHAT IT IS USED FOR
Vosevi is a medicine that contains the active substances sofosbuvir,
velpatasvir and voxilaprevir in a
single tablet. It is given to treat a chronic (long-term) viral
infection of the liver called hepatitis C in
patients aged 12 years and older and weighing at least 30 kg.
The active substances in this medicine work together by blocking three
different proteins that the
hepatitis C virus needs to grow and reproduce itself, causing the
infection to be eliminated from the
body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VOSEVI
DO NOT TAKE VOSEVI
•
IF YOU ARE ALLERGIC
to sofosbuvir, velpatasvir, voxilaprevir or any of the other
ingredients of this
medicine (listed in section 6 of this leaflet).

If this applies to you,
DO NOT TAKE VOSEVI AND TELL YOUR DOCTOR IMMEDIATELY.
•
IF YOU ARE CURRENTLY TAKING ANY OF THE FOLLOWING MEDICINES

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Vosevi 400 mg/100 mg/100 mg film-coated tablets
Vosevi 200 mg/50 mg/50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vosevi 400 mg/100 mg/100 mg film-coated tablets
Each film-coated tablet contains 400 mg sofosbuvir, 100 mg velpatasvir
and 100 mg voxilaprevir.
Excipients with known effect
Each film-coated tablet contains 111 mg of lactose (as monohydrate).
Vosevi 200 mg/50 mg/50 mg film-coated tablets
Each film-coated tablet contains 200 mg sofosbuvir, 50 mg velpatasvir
and 50 mg voxilaprevir.
Excipients with known effect
Each film-coated tablet contains 55 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Vosevi 400 mg/100 mg/100 mg film-coated tablets
Beige, capsule-shaped, film-coated tablet of dimensions 10 mm x 20 mm,
debossed with “GSI” on one
side and “3” on the other side.
Vosevi 200 mg/50 mg/50 mg film-coated tablets
Beige, oval-shaped, film-coated tablet of dimensions 8 mm x 15 mm,
debossed with “GSI” on one
side and “SVV” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vosevi is indicated for the treatment of chronic hepatitis C virus
(HCV) infection in patients aged
12 years and older and weighing at least 30 kg (see sections 4.2, 4.4
and 5.1).
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Vosevi treatment should be initiated and monitored by a physician
experienced in the management of
patients with HCV infection.
Posology
The recommended dose of Vosevi in patients aged 12 years and older and
weighing at least 30 kg is
one 400 mg/100 mg/100 mg tablet or two 200 mg/50 mg/50 mg tablets,
taken orally, once daily with
food (see section 5.2).
The recommended durations of treatment applicable to all HCV genotypes
are shown in Table 1.
TABLE 1: RECOMMENDED TREATMENT DURATIONS FOR VOSEVI FOR ALL HCV
GENOTYPES IN PATIENTS
12 YEARS AND OLDER AND WEIGHING AT LEAST 30 KG
PATIENT POPULATION
TREATMENT DUR