Imraldi

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

adalimumab

Dostupné z:

Samsung Bioepis NL B.V.

ATC kód:

L04AB04

INN (Medzinárodný Name):

adalimumab

Terapeutické skupiny:

Immunosuppressants

Terapeutické oblasti:

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

Terapeutické indikácie:

Rheumatoid arthritisImraldi 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.Imraldi 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 arthritisImraldi 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). Imraldi 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 arthritisImraldi 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)Imraldi 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 ASImraldi 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 (NSAIDs).Psoriatic arthritisImraldi 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.PsoriasisImraldi is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.Paediatric plaque psoriasisImraldi 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)Imraldi 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 diseaseImraldi 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 diseaseImraldi 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 haveUlcerative colitisImraldi 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 mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.Paediatric ulcerative colitisImraldi is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.UveitisImraldi 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 corticosteroidsparing, or in whomcorticosteroid treatment is inappropriate.Paediatric UveitisImraldi 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.

Prehľad produktov:

Revision: 20

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2017-08-24

Príbalový leták

184
B. PACKAGE LEAFLET
185
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMRALDI 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 Imraldi
and during treatment with
Imraldi. Keep this Patient Reminder Card with you during your
treatment and for 4 months after
your (or your child’s) last injection of Imraldi.
-
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 Imraldi is and what it is used for
2.
What you need to know before you use Imraldi
3.
How to use Imraldi
4.
Possible side effects
5.
How to store Imraldi
6.
Contents of the pack and other information
7.
Instructions for use
1.
WHAT IMRALDI IS AND WHAT IT IS USED FOR
Imraldi contains the active substance adalimumab, a medicine that acts
on your body’s immune
(defence) system.
Imraldi is intended for treatment of:

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 ingredient in Imraldi, adalimumab, is a monoclonal
antibody. Monoclonal antibodies are
proteins that attach to a specific target.
The target of adalimumab is a protein called tumour necrosis

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Imraldi 40 mg solution for injection in pre-filled syringe
Imraldi 40 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imraldi 40 mg solution for injection in pre-filled syringe
Each 0.8 ml single dose pre-filled syringe contains 40 mg of
adalimumab.
Imraldi
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.
Excipient(s) with known effect
This medicinal product contains 20.0 mg sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
Clear to opalescent, colourless to pale brown solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Imraldi 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.
Imraldi 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 _
Imraldi 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
3
more disease-modifying anti-rheumatic drugs (DMARDs). Imraldi can be
given as monotherapy in
case of intolerance to methotrexate or when continued treatment with
meth