Amgevita
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
18-01-2023
Valmisteyhteenveto
(SPC)
18-01-2023
Julkisesta arviointikertomuksesta
(PAR)
06-04-2017
Aktiivinen ainesosa:
adalimumab
Saatavilla:
Amgen Europe B.V.
ATC-koodi:
L04AB04
INN (Kansainvälinen yleisnimi):
adalimumab
Terapeuttinen ryhmä:
Immunosuppressants
Terapeuttinen alue:
Arthritis, Psoriatic; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Käyttöaiheet:
Rheumatoid arthritis Amgevita 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. , Amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Amgevita reduces the rate of progression of joint damage as measured by x-ray and improves physical function, when given in combination with methotrexate. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Amgevita 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). Amgevita 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 arthritis Amgevita 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 spondyloarthritis Ankylosing spondylitis (AS) Amgevita 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 AS Amgevita 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 non-steroidal anti-inflammatory drugs. Psoriatic arthritis Amgevita 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. Amgevita reduces 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 improves physical function. Psoriasis Amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Amgevita 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. Hidradenitis suppurativa (HS) Amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2). Crohn’s disease Amgevita 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 disease Amgevita 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 colitis Amgevita 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. Uveitis Amgevita 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 uveitis Amgevita 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.,
Tuoteyhteenveto:
Revision: 11
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2017-03-21
Pakkausseloste
78
B. PACKAGE LEAFLET
79
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMGEVITA 20 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
AMGEVITA 40 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
adalimumab
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 AMGEVITA
and during
treatment with AMGEVITA. Keep this
PATIENT REMINDER CARD
with you.
-
If you have any further questions, 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 AMGEVITA is and what it is used for
2.
What you need to know before you use AMGEVITA
3.
How to use AMGEVITA
4.
Possible side effects
5.
How to store AMGEVITA
6.
Contents of the pack and other information
1.
WHAT AMGEVITA IS AND WHAT IT IS USED FOR
AMGEVITA contains the active substance adalimumab, a medicine that
acts on your body’s immune
(defence) system.
AMGEVITA is intended for the treatment of the inflammatory diseases
described below:
•
Rheumatoid arthritis
•
Polyarticular juvenile idiopathic arthritis
•
Enthesitis-related arthritis
•
Ankylosing spondylitis
•
Axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis
•
Psoriatic arthritis
•
Plaque psoriasis
•
Hidradenitis suppurativa
•
Crohn’s disease
•
Ulcerative colitis
•
Non-infectious uveitis
The active ingredient in AMGEVITA, adalimumab, is a human monoclonal
antibody. Monoclonal
antibodies are proteins that attach to a specific target.
The target of adalimumab is a protein called tumour necrosis factor
(TNFα),
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
AMGEVITA 20 mg solution for injection in pre-filled syringe
AMGEVITA 40 mg solution for injection in pre-filled syringe
AMGEVITA 40 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AMGEVITA 20 mg solution for injection in pre-filled syringe
Each single dose pre-filled syringe contains 20 mg of adalimumab in
0.4 mL solution (50 mg/mL).
AMGEVITA 40 mg solution for injection in pre-filled syringe
Each single dose pre-filled syringe contains 40 mg of adalimumab in
0.8 mL solution (50 mg/mL).
AMGEVITA 40 mg solution for injection in pre-filled pen
Each single dose pre-filled pen contains 40 mg of adalimumab in 0.8 mL
solution (50 mg/mL).
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)
Solution for injection (injection) in pre-filled pen (SureClick)
Clear and colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
AMGEVITA 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 (DMARDs) including
methotrexate has
been inadequate.
•
the treatment of severe, active and progressive rheumatoid arthritis
in adults not previously
treated with methotrexate.
AMGEVITA can be given as monotherapy in case of intolerance to
methotrexate or when continued
treatment with methotrexate is inappropriate.
AMGEVITA reduces the rate of progression of joint damage as measured
by x-ray and improves
physical function, when given in combination with methotrexate.
3
Juvenile idiopathic arthritis
_Polyarticular juvenile idiopathic arthritis _
AMGEVITA in combination with methotrexate is indicated for the
treatment of active polyarticular
juvenile idiopathic arthritis, in pa
Lue koko asiakirja
