Olumiant
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
30-10-2023
Valmisteyhteenveto
(SPC)
30-10-2023
Julkisesta arviointikertomuksesta
(PAR)
21-11-2023
Aktiivinen ainesosa:
Baricitinib
Saatavilla:
Eli Lilly Nederland B.V.
ATC-koodi:
L04AA37
INN (Kansainvälinen yleisnimi):
baricitinib
Terapeuttinen ryhmä:
Immunosuppressants
Terapeuttinen alue:
Arthritis, Rheumatoid
Käyttöaiheet:
Rheumatoid arthritisBaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Olumiant may be used as monotherapy or in combination with methotrexate.Atopic DermatitisOlumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy.Alopecia areataBaricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5.1).Juvenile idiopathic arthritisBaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs:- Polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular),- Enthesitis related arthritis, and- Juvenile psoriatic arthritis.Baricitinib may be used as monotherapy or in combination with methotrexate.
Tuoteyhteenveto:
Revision: 17
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2017-02-13
Pakkausseloste
53
B. PACKAGE LEAFLET
54
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OLUMIANT 1
MG FILM-COATED TABLETS
OLUMIANT 2
MG FILM-COATED TABLETS
OLUMIANT 4
MG FILM-COATED TABLETS
baricitinib
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 or
nurse.
-
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 or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Olumiant is and what it is used for
2.
What you need to know before you take Olumiant
3.
How to take Olumiant
4.
Possible side effects
5.
How to store Olumiant
6.
Contents of the pack and other information
1.
WHAT OLUMIANT IS AND WHAT IT IS USED FOR
Olumiant contains the active substance baricitinib. It belongs to a
group of medicines called Janus
kinase inhibitors, which help to reduce inflammation.
RHEUMATOID ARTHRITIS
Olumiant is used to treat adults with moderate to severe rheumatoid
arthritis, an inflammatory disease
of the joints, if previous therapy did not work well enough or was not
tolerated. Olumiant can be used
alone or together with some other medicines, such as methotrexate.
Olumiant works by reducing the activity of an enzyme in the body
called ‘Janus kinase’, which is
involved in inflammation. By reducing the activity of this enzyme,
Olumiant helps to reduce pain,
stiffness and swelling in your joints, tiredness, and helps to slow
damage to the bone and cartilage in
the joints. These effects can help you to do normal daily activities
and so improve the health-related
quality of life for patients with rheumatoid arthritis.
ATOPIC DERMATITIS
Olumiant is used to treat children from the age of 2 years,
adolescents and adults with mo
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Olumiant 1 mg film-coated tablets
Olumiant 2 mg film-coated tablets
Olumiant 4 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olumiant 1 mg film-coated tablets
Each film-coated tablet contains 1 mg baricitinib.
Olumiant 2 mg film-coated tablets
Each film-coated tablet contains 2 mg baricitinib.
Olumiant 4 mg film-coated tablets
Each film-coated tablet contains 4 mg baricitinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Olumiant 1 mg film-coated tablets
Very light pink, 6.75 mm round tablets, debossed with “Lilly” on
one side and “1” on the other.
Olumiant 2 mg film-coated tablets
Light pink, 9 x 7.5 mm oblong tablets, debossed with “Lilly” on
one side and “2” on the other.
Olumiant 4 mg film-coated tablets
Medium pink, 8.5 mm round tablets, debossed with “Lilly” on one
side and “4” on the other.
The tablets contain a recessed area on each side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Baricitinib is indicated for the treatment of moderate to severe
active rheumatoid arthritis in adult
patients who have responded inadequately to, or who are intolerant to
one or more disease-modifying
anti-rheumatic drugs (DMARDs). Baricitinib may be used as monotherapy
or in combination with
methotrexate (see sections 4.4, 4.5 and 5.1 for available data on
different combinations).
3
Atopic dermatitis
Baricitinib is indicated for the treatment of moderate to severe
atopic dermatitis in adult and paediatric
patients 2 years of age and older who are candidates for systemic
therapy.
Alopecia areata
Baricitinib is indicated for the treatment of severe alopecia areata
in adult patients (see section 5.1).
Juvenile idiopathic arthritis
Baricitinib is indicated for the treatment of active juvenile
idiopathic arthritis in patients 2 years of age
and older who have had an inadequate response or intolerance to one or
more prior con
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