REVOLADE FILM-COATED TABLET 50MG

Land: Malaysia

Sprog: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv bestanddel:

ELTROMBOPAG OLAMINE

Tilgængelig fra:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

ELTROMBOPAG OLAMINE

Enheder i pakken:

28Tablet Tablets; 14Tablet Tablets; 84Tablet Tablets

Fremstillet af:

LEK PHARMACEUTICALS D.D.

Indlægsseddel

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_Consumer Medication Information Leaflet (RiMUP) _
_ _
REVOLADE
® FILM-COATED TABLET
_ _
_ _
Eltrombopag olamine (25 mg, 50mg)
1
WHAT IS IN THIS LEAFLET
1.
WHAT REVOLADE IS USED FOR
2.
HOW REVOLADE WORKS
3.
BEFORE YOU USE REVOLADE
4.
HOW TO USE REVOLADE
5.
WHILE YOU ARE USING IT
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF REVOLADE
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
WHAT REVOLADE IS USED FOR
Revolade may be used to treat a
bleeding disorder called immune
(primary) thrombocytopenia (ITP) in
patients (aged 6 years and over) 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
adult with chronic hepatitis C virus
(HCV) infections, if they have any
problems with side effects while on
interferon treatment. Many people with
hepatitis C have low platelet counts, not
only as a result of the disease, but also
due to some of the antiviral medicines
that are used to treat it. Taking Revolade
may make it easier for you to complete a
full course of antiviral medicine
(peginterferon and ribavirin).
Revolade may be used to treat severe
aplastic anaemia (SAA):
•
in combination with standard
immunosuppressive therapy as
first treatment for adults and
adolescent from 12 years of age.
•
in adults when other medicines
to treat SAA have not worked
well enough.
SAA is a disease in which the bone
marrow is damaged causing a deficiency
of the red blood cells (anaemia), white
blood cells (leukopenia), and platelets
(thrombocytopenia).
HOW REVOLADE WORKS
Eltrombopag the active substance in
Revolade belongs to a group of
medicine

Produktets egenskaber

2
REVOLADE
®
1.
NAME OF THE MEDICINAL PRODUCT
Revolade
25
mg film-coated tablets
Revolade
50
mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Revolade 25mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to
25
mg eltrombopag.
Revolade 50mg film-coated tablets
Each film-coated tablet contains eltrombopag olamine equivalent to
50
mg eltrombopag.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
25mg: Round
, biconvex
, white
film-coated tablet (approximately 10.3 mm in diameter) debossed
with ‘GS NX3’ and ‘25’ on one side.
50mg: Round
, biconvex
, brown
film-coated tablet (approximately 10.3 mm in diameter) debossed
with ‘GS UFU’ and ‘50’ on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Revolade is indicated for the treatment of patients aged
6 years
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
).
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 combination with standard immunosuppressive
therapy for the first-line
treatment of adult and adolescent patients 12 years and older with
severe aplastic anemia.
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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Revolade treatment should be initiated by and remain under the
supervision of a physician who is
3
experienced in the treatment of haematological diseases or the
management of chronic hepatitis