Simponi
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
13-11-2023
Produktets egenskaber
(SPC)
13-11-2023
Offentlige vurderingsrapport
(PAR)
13-03-2019
Aktiv bestanddel:
Golimumab
Tilgængelig fra:
Janssen Biologics B.V.
ATC-kode:
L04AB06
INN (International Name):
golimumab
Terapeutisk gruppe:
Immunosuppressants
Terapeutisk område:
Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Arthritis, Rheumatoid
Terapeutiske indikationer:
Rheumatoid arthritis (RA)Simponi, in combination with methotrexate (MTX), is indicated for:the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease modifying anti rheumatic drug (DMARD) therapy including MTX has been inadequate.the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX.Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function.For information regarding the polyarticular juvenile idiopathic arthritis indication, please see the Simponi 50 mg SmPC.Psoriatic arthritis (PsA)Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Simponi 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.Axial spondyloarthritisAnkylosing spondylitis (AS)Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.Non radiographic axial spondyloarthritis (nr Axial SpA)Simponi is indicated for the treatment of adults with severe, active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).Ulcerative colitis (UC)Simponi 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.Juvenile idiopathic arthritisPolyarticular juvenile idiopathic arthritis (pJIA)Simponi in combination with methotrexate (MTX) is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX.Rheumatoid arthritis (RA)Simponi, in combination with methotrexate (MTX), is indicated for:the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease modifying anti rheumatic drug (DMARD) therapy including MTX has been inadequate.the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX.Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function.Juvenile idiopathic arthritisPolyarticular juvenile idiopathic arthritis (pJIA)Simponi in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX.Psoriatic arthritis (PsA)Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Simponi 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.Axial spondyloarthritisAnkylosing spondylitis (AS)Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.Non radiographic axial spondyloarthritis (nr Axial SpA)Simponi is indicated for the treatment of adults with severe, active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).Ulcerative colitis (UC)Simponi 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.
Produkt oversigt:
Revision: 48
Autorisation status:
Authorised
Autorisation dato:
2009-10-01
Indlægsseddel
129
B. PACKAGE LEAFLET
130
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIMPONI 45 MG/0.45 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
For paediatric patients below 40 kg
golimumab
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.
-
If you have any further questions, ask your doctor, 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
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 Simponi.
WHAT IS IN THIS LEAFLET
1.
What Simponi is and what it is used for
2.
What you need to know before you use Simponi
3.
How to use Simponi
4.
Possible side effects
5.
How to store Simponi
6.
Contents of the pack and other information
1.
WHAT SIMPONI IS AND WHAT IT IS USED FOR
Simponi contains the active substance called golimumab.
Simponi belongs to a group of medicines called ‘TNF blockers’. It
is used IN CHILDREN 2 years of age
and older for the treatment of polyarticular juvenile idiopathic
arthritis.
Simponi works by blocking the action of a protein called ‘tumour
necrosis factor alpha’ (TNF-α). This
protein is involved in inflammatory processes of the body, and
blocking it can reduce the
inflammation in your body.
POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS
Polyarticular juvenile idiopathic arthritis is an inflammatory disease
that causes joint pain and swelling
in children. If you have polyarticular juvenile idiopathic arthritis
you will first be given other
medicines. If you do not respond well enough to these medicines, you
will be given Simponi in
combination with methotrexate to treat the disease.
2.
WHAT YO
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Simponi 45 mg/0.45 mL solution for injection in pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One pre-filled pen contains 45 mg golimumab* in 0.45 mL. 1 mL solution
contains 100 mg
golimumab.
Each pre-filled pen can deliver 0.1 mL to 0.45 mL (corresponding to 10
mg to 45 mg golimumab) in
increments of 0.05 mL.
*
Human IgG1κ monoclonal antibody produced by a murine hybridoma cell
line with
recombinant DNA technology.
Excipient with known effect
Each pre-filled pen contains 18.45 mg sorbitol (E420) per 45 mg dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled pen (injection), VarioJect
The solution is clear to slightly opalescent, colourless to light
yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Juvenile idiopathic arthritis
_Polyarticular juvenile idiopathic arthritis (pJIA)_
Simponi in combination with methotrexate (MTX) is indicated for the
treatment of polyarticular
juvenile idiopathic arthritis in children 2 years of age and older,
who have responded inadequately to
previous therapy with MTX.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment is to be initiated and supervised by qualified physicians
experienced in the diagnosis and
treatment of conditions for which Simponi is indicated. Patients
treated with Simponi should be given
the Patient Reminder Card which is included in the pack.
Posology
The 45 mg/0.45 mL pre-filled pen is for paediatric patients. Each
pre-filled pen is for single use in a
single patient, and should be discarded immediately after use.
Paediatric population
Juvenile idiopathic arthritis
_Polyarticular juvenile idiopathic arthritis in children with body
weight less than 40 kg_
The recommended dose of Simponi for children with a body weight less
than 40 kg with polyarticular
juvenile idiopathic arthritis is 30 mg/m
2
body surface area up to maximum single dose of 40 mg
3
administered once a month, on the same date ea
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