Revolade

Země: Arménie

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivní složka:

eltrombopag (eltrombopag olamine)

Dostupné s:

Glaxo Wellcome S.A.

INN (Mezinárodní Name):

eltrombopag (eltrombopag olamine)

Dávkování:

25mg

Léková forma:

tablets film-coated

Druh předpisu:

Prescription

Informace pro uživatele

62000000001370
English
Package Leaflet: Information for the
patient
25 MG FILM-COATED TABLETS
50 MG FILM-COATED TABLETS
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.
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
Eltrombopag the active substance in Revolade 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 may be used to treat a bleeding disorder called
_immune_ (_idiopathic) thrombocytopenic purpura_ (ITP) in adult
patients (aged 18 years and over) who have had their spleen
removed and have received prior treatment with corticosteroids
or immunoglobulins, and these medicines did not work. ITP
is caused by a low blood platelet count (_thrombocytopenia_).
People with ITP have an increased risk of bleeding, and may
notice symptoms such as _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 may also be used in previously treated adult
patients (aged 18 years and over) with chronic ITP when
surgery to remove the spleen is not an option.
Revolade may also be used to treat low platelet count
_(thr

Charakteristika produktu

REVOLADE
Summary of Product Characteristics Updated 04-Jun-2014 |
GlaxoSmithKline UK
1. NAME OF THE MEDICINAL PRODUCT
Revolade
®
25 mg and 50 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains eltrombopag olamine equivalent to 25
mg or 50 mg
eltrombopag.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
25 mg: Round, biconvex, white film-coated tablet debossed with 'GS
NX3' and '25' on
one side.
50 mg: Round, biconvex, brown film-coated tablet debossed with 'GS
UFU' and '50' on
one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Revolade is indicated for adult chronic immune (idiopathic)
thrombocytopenic purpura
(ITP) splenectomised patients who are refractory to other treatments
(e.g.
corticosteroids, immunoglobulins). Revolade may be considered as
second line
treatment for adult non-splenectomised patients where surgery is
contraindicated.
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).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Eltrombopag treatment should be initiated and remain under the
supervision of a
physician who is experienced in the treatment of haematological
diseases or the
management of chronic hepatitis C and its complications.
Posology
Eltrombopag dosing requirements must be individualised based on the
patient's platelet
counts. The objective of treatment with eltrombopag should not be to
normalise platelet
counts.
In most patients, measurable elevations in platelet counts take 1-2
weeks (see section
5.1).
Chronic immune (idiopathic) thrombocytopenia
The lowest dose of eltrombopag to achieve and maintain a platelet
count ≥ 50,000/µl
should be used. Dose adjustments are based upon the platelet count
response. Do not
use eltrombopag to normali