Harvoni

Država: Evropska unija

Jezik: angleščina

Source: EMA (European Medicines Agency)

Aktivna sestavina:

ledipasvir, Sofosbuvir

Dostopno od:

Gilead Sciences Ireland UC

Koda artikla:

J05AX65

INN (mednarodno ime):

ledispavir, sofosbuvir

Terapevtska skupina:

Antivirals for systemic use

Terapevtsko območje:

Hepatitis C, Chronic

Terapevtske indikacije:

Harvoni is indicated 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.

Povzetek izdelek:

Revision: 28

Status dovoljenje:

Authorised

Datum dovoljenje:

2014-11-17

Navodilo za uporabo

93
B. PACKAGE LEAFLET
94
PACKAGE LEAFLET: INFORMATION FOR THE USER
HARVONI 90 MG/400 MG FILM-COATED TABLETS
HARVONI 45 MG/200 MG FILM-COATED TABLETS
ledipasvir/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 Harvoni is and what it is used for
2.
What you need to know before you take Harvoni
3.
How to take Harvoni
4.
Possible side effects
5.
How to store Harvoni
6.
Contents of the pack and other information
IF HARVONI 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 HARVONI IS AND WHAT IT IS USED FOR
Harvoni is a medicine that contains the active substances ledipasvir
and sofosbuvir. Harvoni is given
to treat chronic (long-term) hepatitis C virus infection in
ADULTS
and
CHILDREN 3 YEARS OF AGE AND
OLDER.
Hepatitis C is a virus that infects the liver. The active substances
in the medicine work together by
blocking two different proteins that the virus needs to grow and
reproduce itself, allowing the infection
to be permanently eliminated from the body.
Harvoni is sometimes taken with another medicine, ribavirin.
It is very important that you also read the leaflets for the other
medicines that you will be taking with
Harvoni. If you have any questions about your medicines, please ask
your doctor or pharmacist.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE HARVONI
DO NOT TAKE HARVONI
•
IF YOU ARE ALLERGIC
to ledipasvir, sofosbuvir or any of the other in

Lastnosti izdelka

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Harvoni 90 mg/400 mg film-coated tablets
Harvoni 45 mg/200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Harvoni 90 mg/400 mg film-coated tablets
Each film-coated tablet contains 90 mg ledipasvir and 400 mg
sofosbuvir.
Excipients with known effect
Each film-coated tablet contains 157 mg of lactose (as monohydrate)
and 47 micrograms of sunset
yellow FCF.
Harvoni 45 mg/200 mg film-coated tablets
Each film-coated tablet contains 45 mg ledipasvir and 200 mg
sofosbuvir.
Excipients with known effect
Each film-coated tablet contains 78 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Harvoni 90 mg/400 mg film-coated tablets
Orange, diamond-shaped, film-coated tablet of dimensions of
approximately 19 mm x 10 mm,
debossed with “GSI” on one side and “7985” on the other side.
Harvoni 45 mg/200 mg film-coated tablets
White, capsule-shaped, film-coated tablet of dimensions of
approximately 14 mm x 7 mm, debossed
with “GSI” on one side and “HRV” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Harvoni is indicated 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Harvoni treatment should be initiated and monitored by a physician
experienced in the management of
patients with CHC.
3
Posology
The recommended dose of Harvoni in adults is 90 mg/400 mg once daily
with or without food (see
section 5.2).
The recommended dose of Harvoni in paediatric patients aged 3 years
and above is based on weight
(as detailed in Table 2) and can be taken with or without food (see
section 5.2).
A granule formulation of Harvoni is available for the treatment of
chronic HCV-infection in paediatric
patients aged 3 years and above havin