Sovaldi

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

Sofosbuvir

Saadav alates:

Gilead Sciences Ireland UC

ATC kood:

J05AX15

INN (Rahvusvaheline Nimetus):

sofosbuvir

Terapeutiline rühm:

Antivirals for systemic use

Terapeutiline ala:

Hepatitis C, Chronic

Näidustused:

Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.

Toote kokkuvõte:

Revision: 28

Volitamisolek:

Authorised

Loa andmise kuupäev:

2014-01-16

Infovoldik

79
B. PACKAGE LEAFLET
80
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOVALDI 400 MG FILM-COATED TABLETS
SOVALDI 200 MG FILM-COATED TABLETS
sofosbuvir
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 Sovaldi is and what it is used for
2.
What you need to know before you take Sovaldi
3.
How to take Sovaldi
4.
Possible side effects
5.
How to store Sovaldi
6.
Contents of the pack and other information
IF SOVALDI HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL
THE INFORMATION IN THIS LEAFLET IS
APPLICABLE TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD”
INSTEAD OF “YOU”).
1.
WHAT SOVALDI IS AND WHAT IT IS USED FOR
Sovaldi contains the active substance sofosbuvir which is given to
treat hepatitis C virus infection in
adults and children 3 years of age and older.
Hepatitis C is a virus that infects the liver. This medicine works by
lowering the amount of hepatitis C
virus in your body and removing the virus from your blood over a
period of time.
Sovaldi is always taken with other medicines to treat hepatitis C. It
will not work on its own. It is
commonly taken with either:
•
Ribavirin (children and adult patients), or
•
Peginterferon alfa and ribavirin (adult patients)
It is very important that you also read the leaflets for the other
medicines that you will be taking with
Sovaldi. If you have any questions about your medicines, please ask
your doctor or pharmacist.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOVALDI
DO NOT TAKE SOVALDI
•
If you are allergic to sofosbuvir or

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sovaldi 400 mg film-coated tablets
Sovaldi 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sovaldi 400 mg film-coated tablets
Each film-coated tablet contains 400 mg of sofosbuvir.
Sovaldi 200 mg film-coated tablets
Each film-coated tablet contains 200 mg of sofosbuvir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Sovaldi 400 mg film-coated tablets
Yellow, capsule-shaped, film-coated tablet of dimensions of
approximately 20 mm x 9 mm, debossed
on one side with “GSI” and “7977” on the other side.
Sovaldi 200 mg film-coated tablets
Yellow, oval-shaped, film-coated tablet of dimensions of approximately
15 mm x 8 mm, debossed on
one side with “GSI” and “200” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sovaldi is indicated in combination with other medicinal products for
the treatment of chronic
hepatitis C (CHC) in adults and paediatric patients aged 3 years and
above (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
Sovaldi treatment should be initiated and monitored by a physician
experienced in the management of
patients with CHC.
Posology
The recommended dose of Sovaldi in adults is one 400 mg tablet, taken
orally, once daily with food
(see section 5.2).
The recommended dose of Sovaldi in paediatric patients aged 3 years
and above is based on weight (as
detailed in Table 2). Sovaldi should be taken with food (see section
5.2).
3
Sovaldi oral granules are available for the treatment of chronic
HCV-infection in paediatric patients
aged 3 years and above having difficulty in swallowing film-coated
tablets. Please refer to the
Summary of Product Characteristics for Sovaldi 150 mg or 200 mg
granules.
Sovaldi should be used in combination with other medicinal products.
Monotherapy of Sovaldi is not
recommended (see section