Vosevi 400mg100mg100mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Voxilaprevir; Velpatasvir; Sofosbuvir

Dostupné z:

Gilead Sciences International Ltd

ATC kód:

J05AP56

INN (Medzinárodný Name):

Voxilaprevir; Velpatasvir; Sofosbuvir

Dávkovanie:

100mg ; 100mg ; 400mg

Forma lieku:

Tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Never Valid To Prescribe As A VMP

Prehľad produktov:

BNF:

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VOSEVI 400 MG/100 MG/100 MG FILM-COATED TABLETS
sofosbuvir/velpatasvir/voxilaprevir
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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
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 adults of 18 years and older treat a
chronic (long-term) viral infection of
the liver called hepatitis C.
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:
•
RIFAMPICIN
and
RIFABUTIN
(antibiotics used to treat infections

Súhrn charakteristických

OBJECT 1
VOSEVI 400 MG/100 MG/100 MG FILM COATED TABLETS
Summary of Product Characteristics Updated 15-Jun-2018 | Gilead
Sciences Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Vosevi 400 mg/100 mg/100 mg film-coated tablets
2. Qualitative and quantitative composition
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 lactose
monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Beige, capsule-shaped, film-coated tablet of dimensions 10 mm x 20 mm,
debossed with “GSI” on one
side and “
” 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 adults (see sections
4.2, 4.4 and 5.1).
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 is one tablet, 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
PATIENT POPULATION
TREATMENT DURATION
DAA naïve patients without cirrhosis
8 weeks
DAA naïve patients with compensated cirrhosis
12 weeks
8 weeks may be considered in genotype 3
infected patients (see section 5.1)
DAA experienced patients* without cirrhosis or with
compensated cirrhosis
12 weeks
DAA: direct-acting antiviral agent
* In clinical trials the DAA experienced patients had been exposed to
combination regimens containing
any of the following: daclatasvir, dasabu