Humira

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

adalimumab

Dostupné z:

AbbVie Deutschland GmbH Co. KG

ATC kód:

L04AB04

INN (Medzinárodný Name):

adalimumab

Terapeutické skupiny:

Immunosuppressants

Terapeutické oblasti:

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

Terapeutické indikácie:

Please refer to the product information document.

Prehľad produktov:

Revision: 89

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2003-09-08

Príbalový leták

317
B. PACKAGE LEAFLET
318
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HUMIRA 20 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
adalimumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION.

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 your child begins
using Humira and during
treatment with Humira. Keep this PATIENT REMINDER CARD with you or
your child.

If you have any questions, ask your doctor or pharmacist.

This medicine has been prescribed for your child only. Do not pass it
on to others. It may harm
them, even if their signs of illness are the same as your child.

If your child gets 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 Humira is and what it is used for
2.
What you need to know before your child uses Humira
3.
How to use Humira
4.
Possible side effects
5
How to store Humira
6.
Contents of the pack and other information
7.
Injecting Humira
1.
WHAT HUMIRA IS AND WHAT IT IS USED FOR
Humira contains the active substance adalimumab.
Humira is intended for the treatment of the inflammatory diseases
described below:

Polyarticular juvenile idiopathic arthritis

Enthesitis-related arthritis

Paediatric plaque psoriasis

Paediatric Crohn’s disease

Paediatric uveitis
The active ingredient in Humira, adalimumab, is a human monoclonal
antibody. Monoclonal antibodies
are proteins that attach to a specific target.
The target of adalimumab is a protein called tumour necrosis factor
(TNFα), which is involved in the
immune (defence) system and is present at increased levels in the
inflammatory diseases listed above. By
attaching to TNFα, Humira decreases the process of inflammation in
these diseases.
Polyarticular juvenile idiopathic arthritis
Poly

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Humira 20 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.2 ml single dose pre-filled syringe contains 20 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
Juvenile idiopathic arthritis
_Polyarticular juvenile idiopathic arthritis_
Humira 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). Humira 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). Humira has not been studied
in patients aged less than 2 years.
_Enthesitis-related arthritis_
Humira 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).
Paediatric plaque psoriasis
Humira 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.
Paediatric Crohn's disease
Humira 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.
3
Paediatric Uveitis
Humira is i