Idacio

Country: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

adalimumab

Fáanlegur frá:

Fresenius Kabi Deutschland GmbH

ATC númer:

L04AB04

INN (Alþjóðlegt nafn):

adalimumab

Meðferðarhópur:

Immunosuppressants

Lækningarsvæði:

Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid

Ábendingar:

Rheumatoid arthritisIdacio 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.Idacio 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 arthritisIdacio 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 arthritisIdacio 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)Idacio 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 ASIdacio 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 arthritisIdacio 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.PsoriasisIdacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.Paediatric plaque psoriasisIdacio 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)Idacio 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.Crohn’s diseaseIdacio 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 diseaseIdacio 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 colitisIdacio 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.UveitisIdacio 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 UveitisIdacio 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.

Vörulýsing:

Revision: 11

Leyfisstaða:

Authorised

Leyfisdagur:

2019-04-02

Upplýsingar fylgiseðill

123
B. PACKAGE LEAFLET
124
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IDACIO 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 Idacio
and during treatment with
Idacio. Keep this patient reminder card with you during your treatment
and for 4 months after
your (or your child’s) last injection of Idacio.
-
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 Idacio is and what it is used for
2.
What you need to know before you use Idacio
3.
How to use Idacio
4.
Possible side effects
5.
How to store Idacio
6.
Contents of the pack and other information
7.
Instructions for use
1.
WHAT IDACIO IS AND WHAT IT IS USED FOR
Idacio contains the active substance adalimumab, a medicine that acts
on your body’s immune
(defence) system.
Idacio 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,
•
hidradenitis suppurativa,
•
Crohn’s disease,
•
ulcerative colitis and
•
non-infectious uveitis
The active substance in Idacio, adalimumab, is a monoclonal antibody.
Monoclonal antibodies are
proteins that attach to a specific target in the body.
The target of adalimuma

Vara einkenni

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Idacio 40 mg solution for injection in pre-filled syringe
Idacio 40 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Idacio 40 mg solution for injection in pre-filled syringe
Each 0.8 ml single dose pre-filled syringe contains 40 mg of
adalimumab.
Idacio 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
Idacio 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.
Idacio 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.
3
Juvenile idiopathic arthritis
_Polyarticular juvenile idiopathic arthritis_
Idacio 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 pa