Remsima

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

infliximab

Διαθέσιμο από:

Celltrion Healthcare Hungary Kft.

Φαρμακολογική κατηγορία (ATC):

L04AB02

INN (Διεθνής Όνομα):

infliximab

Θεραπευτική ομάδα:

Immunosuppressants

Θεραπευτική περιοχή:

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

Θεραπευτικές ενδείξεις:

Rheumatoid arthritisRemsima, 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 diseaseRemsima 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 diseaseRemsima 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. Infliximab has been studied only in combination with conventional immunosuppressive therapy.Ulcerative colitisRemsima 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 colitisRemsima is indicated for treatment of severely active ulcerative colitis in children and adolescents 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 spondylitisRemsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.Psoriatic arthritisRemsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.Remsima should be administered:in combination with methotrexate;or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.Infliximab 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.PsoriasisRemsima 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 ultra-violet A (PUVA).

Περίληψη προϊόντος:

Revision: 37

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2013-09-10

Φύλλο οδηγιών χρήσης

93
B. PACKAGE LEAFLET
94
PACKAGE LEAFLET: INFORMATION FOR THE USER
REMSIMA 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 Remsima.
•
When starting a new card, keep this card as a reference for 4 months
after your last dose of
Remsima.
•
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 Remsima is and what it is used for
2.
What you need to know before you use Remsima
3.
How Remsima will be given
4.
Possible side effects
5.
How to store Remsima
6.
Contents of the pack and other information
1.
WHAT REMSIMA IS AND WHAT IT IS USED FOR
Remsima 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.
Remsima 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.
Remsima is also used in adults and children 6 years of age or older
for:
•
Crohn’s disease
•
Ulcerative colitis.
Remsima 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 diseas

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
2
1.
NAME OF THE MEDICINAL PRODUCT
Remsima 100 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 100 mg of infliximab*. After reconstitution each mL
contains 10 mg of infliximab.
* Infliximab is a chimeric human-murine IgG1 monoclonal antibody
produced in murine hybridoma
cells by recombinant DNA technology.
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 white.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Rheumatoid arthritis
Remsima, 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
Remsima 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
Remsima 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 corticosteroid, an
immunomodu