Revolade

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Eltrombopag

Saatavilla:

Novartis Europharm Limited

ATC-koodi:

B02BX05

INN (Kansainvälinen yleisnimi):

eltrombopag

Terapeuttinen ryhmä:

Other systemic hemostatics, Antihemorrhagics

Terapeuttinen alue:

Purpura, Thrombocytopenic, Idiopathic

Käyttöaiheet:

Revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).Revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4.4 and 5.1).Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.1).

Tuoteyhteenveto:

Revision: 34

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2010-03-11

Pakkausseloste

108
B. PACKAGE LEAFLET
109
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
REVOLADE 12.5 MG FILM-COATED TABLETS
REVOLADE 25 MG FILM-COATED TABLETS
REVOLADE 50 MG FILM-COATED TABLETS
REVOLADE 75 MG FILM-COATED TABLETS
eltrombopag
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 of the 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 Revolade is and what it is used for
2.
What you need to know before you take Revolade
3.
How to take Revolade
4.
Possible side effects
5.
How to store Revolade
6.
Contents of the pack and other information
1.
WHAT REVOLADE IS AND WHAT IT IS USED FOR
Revolade contains eltrombopag, which belongs to a group of medicines
called
thrombopoietin-receptor agonists
_. _
It is used to help increase the number of platelets in your blood.
Platelets are blood cells that help to reduce or prevent bleeding.
•
Revolade is used to treat a bleeding disorder
called immune (primary) thrombocytopenia (ITP)
in patients aged 1 year and above who have already taken other
medicines (corticosteroids or
immunoglobulins), which have not worked.
ITP is caused by a low blood platelet count (thrombocytopenia). People
with ITP have an
increased risk of bleeding. Symptoms patients with ITP may notice
include petechiae (pinpoint-
sized flat round red spots under the skin), bruising, nosebleeds,
bleeding gums and not being
able to control bleeding if they are cut or injured.
•
Revolade can also be used to treat low platelet count
(thrombocytopenia) in adults with
hepatitis C virus (HCV) infections, if they have had problems with
side effects while on

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Revolade 12.5 mg film-coated tablets
Revolade 25 mg film-coated tablets
Revolade 50 mg film-coated tablets
Revolade 75 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Revolade 12.5 mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to
12.5 mg eltrombopag.
Revolade 25 mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 25
mg eltrombopag.
Revolade 50 mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 50
mg eltrombopag.
Revolade 75 mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to 75
mg eltrombopag.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Revolade 12.5 mg film-coated tablets
White, round, biconvex film-coated tablet (approximately 7.9 mm in
diameter) debossed with ‘GS
MZ1’ and ‘12.5’ on one side.
Revolade 25 mg film-coated tablets
White, round, biconvex film-coated tablet (approximately 10.3 mm in
diameter) debossed with ‘GS
NX3’ and ‘25’ on one side.
Revolade 50 mg film-coated tablets
Brown, round, biconvex film-coated tablet (approximately 10.3 mm in
diameter) debossed with ‘GS
UFU’ and ‘50’ on one side.
Revolade 75 mg film-coated tablets
Pink, round, biconvex film-coated tablet (approximately 10.3 mm in
diameter) debossed with ‘GS
FFS’ and ‘75’ on one side.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Revolade is indicated for the treatment of adult patients with primary
immune thrombocytopenia (ITP)
who are refractory to other treatments (e.g. corticosteroids,
immunoglobulins) (see sections 4.2 and
5.1).
Revolade is indicated for the treatment of paediatric patients aged 1
year and above with primary
immune thrombocytopenia (ITP) lasting 6 months or longer from
diagnosis and who are refractory to
other treatments (e.g. corticosteroids, immunoglobulins) (see sections
4.2 an