Remicade

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

infliximab

Διαθέσιμο από:

Janssen Biologics B.V. 

Φαρμακολογική κατηγορία (ATC):

L04AB02

INN (Διεθνής Όνομα):

infliximab

Θεραπευτική ομάδα:

Immunosuppressants

Θεραπευτική περιοχή:

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

Θεραπευτικές ενδείξεις:

Rheumatoid arthritisRemicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate;adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated.Adult Crohn's diseaseRemicade 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;treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).Paediatric Crohn's diseaseRemicade is indicated for treatment of severe, active Crohn's disease, in children and adolescents aged six to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Remicade has been studied only in combination with conventional immunosuppressive therapy.Ulcerative colitisRemicade 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.Paediatric ulcerative colitisRemicade is indicated for treatment of severely active ulcerative colitis, in paediatric patients aged six to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.Ankylosing spondylitisRemicade is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.Psoriatic arthritisRemicade is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.Remicade should be administered:in combination with methotrexate;or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.Remicade has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.PsoriasisRemicade is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultraviolet A (PUVA).

Περίληψη προϊόντος:

Revision: 61

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

1999-08-13

Φύλλο οδηγιών χρήσης

46
B. PACKAGE LEAFLET
47
PACKAGE LEAFLET: INFORMATION FOR THE USER
REMICADE 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
infliximab
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 you need to be aware of before and during your treatment
with Remicade.

If you have any further questions, ask your doctor.

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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Remicade is and what it is used for
2.
What you need to know before you use Remicade
3.
How Remicade will be given
4.
Possible side effects
5.
How to store Remicade
6.
Contents of the pack and other information
1.
WHAT REMICADE IS AND WHAT IT IS USED FOR
Remicade contains the active substance infliximab. Infliximab is a
monoclonal antibody – a type of
protein that attaches to a specific target in the body called TNF
(tumour necrosis factor) alpha.
Remicade belongs to a group of medicines called ‘TNF blockers’. It
is used in adults for the following
inflammatory diseases:

Rheumatoid arthritis

Psoriatic arthritis

Ankylosing spondylitis (Bechterew’s disease)

Psoriasis.
Remicade is also used in adults and children 6 years of age or older
for:

Crohn’s disease

Ulcerative colitis.
Remicade works by selectively attaching to TNF alpha and blocking its
action. TNF alpha is involved
in inflammatory processes of the body so blocking it can reduce the
inflammation in your body.
RHEUMATOID ARTHRITIS
Rheumatoid arthritis is an inflammatory disease of the joints. If you
have active rheumatoid arthritis
you will first be given other medic

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Remicade 100 mg powder for concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of infliximab. Infliximab is a chimeric
human-murine IgG1 monoclonal
antibody produced in murine hybridoma cells by recombinant DNA
technology. After reconstitution
each ml contains 10 mg of infliximab.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
The powder is a freeze-dried white pellet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Remicade, in combination with methotrexate, is indicated for the
reduction of signs and symptoms as
well as the improvement in physical function in:

adult patients with active disease when the response to
disease-modifying antirheumatic drugs
(DMARDs), including methotrexate, has been inadequate.

adult patients with severe, active and progressive disease not
previously treated with
methotrexate or other DMARDs.
In these patient populations, a reduction in the rate of the
progression of joint damage, as measured by
X-ray, has been demonstrated (see section 5.1).
Adult Crohn’s disease
Remicade 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.

treatment of fistulising, active Crohn’s disease, in adult patients
who have not responded despite
a full and adequate course of therapy with conventional treatment
(including antibiotics,
drainage and immunosuppressive therapy).
Paediatric Crohn’s disease
Remicade is indicated for treatment of severe, active Crohn’s
disease, in children and adolescents aged
6 to 17 years, who have not responded to conventional therapy
including a corticoste