REVOLADE 50 MG

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

ELTROMBOPAG AS OLAMINE

Prieinama:

NOVARTIS ISRAEL LTD

ATC kodas:

B02BX05

Vaisto forma:

FILM COATED TABLETS

Sudėtis:

ELTROMBOPAG AS OLAMINE 50 MG

Vartojimo būdas:

PER OS

Recepto tipas:

Required

Pagaminta:

LEK PHARMACEUTICALS D.D., SLOVENIA

Farmakoterapinė grupė:

ELTROMBOPAG

Gydymo sritis:

ELTROMBOPAG

Terapinės indikacijos:

Revolade is indicated for the treatment of patients aged 6 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)Revolade is indicated for the treatment of adult patients with severe aplastic anaemia who have had an insufficient response to immunosuppressive therapy.Revolade is indicated for the treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.Revolade is indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 6 years and older with severe aplastic anemia.

Leidimo data:

2015-05-31

Pakuotės lapelis

REV APL OCT 21 V2.1
EU SmPC 2.21
LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS)
-
1986
This medicine is dispensed with a doctor's prescription only
REVOLADE 25 MG
REVOLADE 50 MG
FILM-COATED TABLETS
EACH FILM-COATED TABLET CONTAINS:
eltrombopag (as olamine) 25 mg or 50 mg
Inactive ingredients and allergens: see section 2 under ‘Important
information
about some of this medicine’s ingredients’, and section 6
‘Additional
information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have any
further questions, consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if it seems to you that their medical condition is
similar to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
•
For the treatment of patients aged 6 years and above with primary
immune
thrombocytopenia (ITP) lasting 6 months or longer from diagnosis,
which
is refractory to other treatments (e.g. corticosteroids,
immunoglobulins).
ITP is caused by a low blood platelet count (thrombocytopenia). People
with ITP have an increased risk of bleeding. Symptoms patients with
ITP
may include petechiae (small flat round red spots under the skin),
bruising,
nosebleeds, bleeding gums and not being able to control bleeding if
they
are cut or injured.
•
For the treatment of thrombocytopenia (low blood platelet count) in
adult
patients with chronic hepatitis C (HCV) to allow the initiation and
maintenance of interferon-based therapy.
•
For the treatment of severe aplastic anaemia (SAA) in combination with
other medicines for treatment of SAA as first-line treatment of adults
and
children 6 years and older.
•
For the treatment of adult patients with severe aplastic anaemia (SAA)
who have had an insufficient response to immunosuppressive therapy.
Severe aplastic anaemia (SAA) is a disease in which the bone marrow is
damaged, causing a deficiency of the red blood cells (ana

Prekės savybės

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REV API SEP23 V3 EU SmPC 6.23
1.
NAME OF THE MEDICINAL PRODUCT
Revolade
®
25 mg
Revolade
®
50 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Revolade 25
mg film-coated tablets
White, round, biconvex, film-coated tablet debossed with ‘GS NX3’
and ‘25’ on one side.
Revolade 50 mg film-coated tablets
Brown, round, biconvex, film-coated tablet 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) (see sections 4.2
and 5.1).
Revolade is indicated for the treatment of thrombocytopenia in adult
patients with chronic hepatitis C
to allow the initiation and maintenance of interferon-based therapy.
Revolade is indicated in combination with standard immunosuppressive
therapy for the first-line
treatment of adult and paediatric patients 6 years and older with
severe aplastic anaemia.
Revolade is indicated for the treatment of adult patients with severe
aplastic anaemia who have had an
insufficient response to immunosuppressive therapy.
4.2
Posology and method of administration
Eltrombopag treatment should be initiated by 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 co