Kromeya
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
23-10-2019
Karatteristiċi tal-prodott
(SPC)
23-10-2019
Rapport ta 'Valutazzjoni Pubblika
(PAR)
24-03-2020
Ingredjent attiv:
adalimumab
Disponibbli minn:
Fresenius Kabi Deutschland GmbH
Kodiċi ATC:
L04AB04
INN (Isem Internazzjonali):
adalimumab
Grupp terapewtiku:
Immunosuppressants
Żona terapewtika:
Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Psoriasis; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Colitis, Ulcerative; Crohn Disease
Indikazzjonijiet terapewtiċi:
Rheumatoid arthritisKromeya in combination with methotrexate, is indicated for:the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.Kromeya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.Juvenile idiopathic arthritisPolyarticular juvenile idiopathic arthritisKromeya in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years.Enthesitis-related arthritisKromeya is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).Axial spondyloarthritisAnkylosing spondylitis (AS)Kromeya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.Axial spondyloarthritis without radiographic evidence of ASKromeya is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.Psoriatic arthritisKromeya is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.Adalimumab has been shown 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) and to improve physical function.PsoriasisKromeya is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.Paediatric plaque psoriasisKromeya is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.Crohn’s diseaseKromeya 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.Paediatric Crohn's diseaseKromeya is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.Ulcerative colitisKromeya 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.UveitisKromeya is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid- sparing, or in whom corticosteroid treatment is inappropriate.Paediatric UveitisKromeya is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Sommarju tal-prodott:
Revision: 4
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2019-04-02
Fuljett ta 'informazzjoni
109
B. PACKAGE LEAFLET
110
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KROMEYA 40 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
adalimumab
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 that you need to be aware of before you are given Kromeya
and during treatment
with Kromeya. Keep this patient reminder card with you during your
treatment and for 4 months
after your (or your child’s) last injection of Kromeya.
-
If you have any further questions, please 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 side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet (see section 4).
WHAT IS IN THIS LEAFLET
1.
What Kromeya is and what it is used for
2.
What you need to know before you use Kromeya
3.
How to use Kromeya
4.
Possible side effects
5.
How to store Kromeya
6.
Contents of the pack and other information
7.
Instructions for use
1.
WHAT KROMEYA IS AND WHAT IT IS USED FOR
Kromeya contains the active substance adalimumab, a medicine that acts
on your body’s immune
(defence) system.
Kromeya is intended for the treatment of the following inflammatory
diseases:
•
rheumatoid arthritis,
•
polyarticular juvenile idiopathic arthritis,
•
enthesitis-related arthritis,
•
ankylosing spondylitis,
•
axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis,
•
psoriatic arthritis,
•
psoriasis,
•
Crohn’s disease,
•
ulcerative coli
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Kromeya 40 mg solution for injection in pre-filled syringe
Kromeya 40 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kromeya 40 mg solution for injection in pre-filled syringe
Each 0.8 ml single dose pre-filled syringe contains 40 mg of
adalimumab.
Kromeya 40 mg solution for injection in pre-filled pen
Each 0.8 ml single dose pre-filled pen contains 40 mg of adalimumab.
Adalimumab is a recombinant human monoclonal antibody produced in
Chinese Hamster Ovary cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Solution for injection (injection).
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Kromeya in combination with methotrexate, is indicated for:
▪
the treatment of moderate to severe, active rheumatoid arthritis in
adult patients when the response
to disease-modifying anti-rheumatic drugs including methotrexate has
been inadequate.
▪
the treatment of severe, active and progressive rheumatoid arthritis
in adults not previously treated
with methotrexate.
Kromeya can be given as monotherapy in case of intolerance to
methotrexate or when continued
treatment with methotrexate is inappropriate.
Adalimumab has been shown to reduce the rate of progression of joint
damage as measured by X-ray
and to improve physical function, when given in combination with
methotrexate.
Juvenile idiopathic arthritis
_Polyarticular juvenile idiopathic arthritis_
3
Kromeya in combination with methotrexate is indicated for the
treatment of active polyarticular
juvenile idiopathic arthritis, in patients from the age of 2 years who
have had an inadequate response
to one or more disease-mod
Aqra d-dokument sħiħ
