Flixabi
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
22-12-2022
Valmisteyhteenveto
(SPC)
22-12-2022
Julkisesta arviointikertomuksesta
(PAR)
09-06-2016
Aktiivinen ainesosa:
infliximab
Saatavilla:
Samsung Bioepis NL B.V.
ATC-koodi:
L04AB02
INN (Kansainvälinen yleisnimi):
infliximab
Terapeuttinen ryhmä:
Immunosuppressants
Terapeuttinen alue:
Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Arthritis, Rheumatoid; Crohn Disease; Psoriasis
Käyttöaiheet:
Rheumatoid arthritisFlixabi, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate.dult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated (see section 5.1).Adult Crohn’s diseaseFlixabi is indicated for:reatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.reatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).Paediatric Crohn’s diseaseFlixabi is indicated for treatment of severe, active Crohn’s disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy.Ulcerative colitisFlixabi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.Paediatric ulcerative colitisFlixabi is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.Ankylosing spondylitisFlixabiis indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.Psoriatic arthritisFlixabi is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.Flixabi should be administered:in combination with methotrexateor alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1).PsoriasisFlixabi is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1).
Tuoteyhteenveto:
Revision: 23
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2016-05-26
Pakkausseloste
47
B. PACKAGE LEAFLET
48
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLIXABI 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
infliximab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
Your doctor will also give you a patient reminder card, which contains
important safety information
you need to be aware of before and during your treatment with Flixabi.
•
If you have any further questions, ask your doctor.
•
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Flixabi is and what it is used for
2.
What you need to know before Flixabi is given
3.
How Flixabi will be given
4.
Possible side effects
5.
How to store Flixabi
6.
Contents of the pack and other information
1.
WHAT FLIXABI IS AND WHAT IT IS USED FOR
Flixabi contains the active substance infliximab. Infliximab is a
monoclonal antibody – a type of protein that
attaches to a specific target in the body called TNF (tumour necrosis
factor) alpha.
Flixabi belongs to a group of medicines called ‘TNF blockers’. It
is used in adults for the following
inflammatory diseases:
•
Rheumatoid arthritis
•
Psoriatic arthritis
•
Ankylosing spondylitis (Bechterew’s disease)
•
Psoriasis.
Flixabi is also used in adults and children 6 years of age or older
for:
•
Crohn’s disease
•
Ulcerative colitis.
Flixabi works by selectively attaching to TNF alpha and blocking its
action. TNF alpha is involved in
inflammatory processes of the body so blocking it can reduce the
inflammation in your body.
RHEUMATOID ARTHRITIS
Rheumatoid arthritis is an inflammatory disease of the joints. If you
have active rheumatoid arthritis you will
first be given other medicines. If these medicines do not work well
enough, you will be given Flixabi which
you will take in combination with another medicine called methotrexate
to:
•
Red
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Flixabi 100 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of infliximab*. After reconstitution, each
mL contains 10 mg of infliximab.
* Infliximab is a chimeric human-murine IgG1 monoclonal antibody
produced in Chinese Hamster Ovary
(CHO) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate)
White powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Flixabi, in combination with methotrexate, is indicated for the
reduction of signs and symptoms as well as
the improvement in physical function in:
adult patients with active disease when the response to
disease-modifying antirheumatic drugs
(DMARDs), including methotrexate, has been inadequate.
adult patients with severe, active and progressive disease not
previously treated with methotrexate or
other DMARDs.
In these patient populations, a reduction in the rate of the
progression of joint damage, as measured by X-ray,
has been demonstrated (see section 5.1).
Adult Crohn’s disease
Flixabi is indicated for:
treatment of moderately to severely active Crohn’s disease, in adult
patients who have not responded
despite a full and adequate course of therapy with a corticosteroid
and/or an immunosuppressant; or
who are intolerant to or have medical contraindications for such
therapies.
treatment of fistulising, active Crohn’s disease, in adult patients
who have not responded despite a full
and adequate course of therapy with conventional treatment (including
antibiotics, drainage and
immunosuppressive therapy).
Paediatric Crohn’s disease
Flixabi is indicated for treatment of severe, active Crohn’s disease
in children and adolescents aged 6 to
17 years, who have not responded to conventional therapy including a
corticosteroid, an immunomodula
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