Ilaris

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

Canakinumab

Saadav alates:

Novartis Europharm Limited

ATC kood:

L04AC08

INN (Rahvusvaheline Nimetus):

canakinumab

Terapeutiline rühm:

Interleukin inhibitors,

Terapeutiline ala:

Cryopyrin-Associated Periodic Syndromes; Arthritis, Juvenile Rheumatoid; Arthritis, Gouty

Näidustused:

Periodic fever syndromesIlaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:Cryopyrin-associated periodic syndromesIlaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including:Muckle-Wells syndrome (MWS),Neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological, cutaneous, articular syndrome (CINCA),Severe forms of familial cold autoinflammatory syndrome (FCAS) / familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash.Tumour necrosis factor receptor associated periodic syndrome (TRAPS)Ilaris is indicated for the treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS).Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD)Ilaris is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD).Familial Mediterranean fever (FMF)Ilaris is indicated for the treatment of Familial Mediterranean Fever (FMF). Ilaris should be given in combination with colchicine, if appropriate.Ilaris is also indicated for the treatment of:Still’s diseaseIlaris is indicated for the treatment of active Still’s disease including adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate.Gouty arthritisIlaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate.

Toote kokkuvõte:

Revision: 30

Volitamisolek:

Authorised

Loa andmise kuupäev:

2009-10-23

Infovoldik

65
B. PACKAGE LEAFLET
66
PACKAGE LEAFLET: INFORMATION FOR THE USER
ILARIS 150 MG POWDER FOR SOLUTION FOR INJECTION
canakinumab
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.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Ilaris is and what it is used for
2.
What you need to know before you use Ilaris
3.
How to use Ilaris
4.
Possible side effects
5.
How to store Ilaris
6.
Contents of the pack and other information
1.
WHAT ILARIS IS AND WHAT IT IS USED FOR
WHAT ILARIS IS
Ilaris contains the active substance canakinumab, a monoclonal
antibody that belongs to a group of
medicines called interleukin inhibitors. It blocks the activity of a
substance called interleukin-1 beta
(IL-1 beta) in the body, which is present at increased levels in
inflammatory diseases.
WHAT ILARIS IS USED FOR
Ilaris is used for treatment of the following inflammatory diseases:
-
Periodic fever syndromes:
•
Cryopyrin-associated periodic syndromes (CAPS),
•
Tumour necrosis factor receptor associated periodic syndrome (TRAPS),
•
Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency
(MKD),
•
Familial Mediterranean fever (FMF).
-
Still’s disease including adult onset Still’s disease (AOSD) and
systemic juvenile idiopathic
arthritis (SJIA)
-
Gouty arthritis
More information on each of these diseases is given below.
67
Periodic fever syndromes
Ilaris is used in adults and children aged 2 years and older to treat
the following:
-
Cryopyrin-associated periodic syndromes (CAPS) – this is a group of
auto-inflammatory
diseases, which include:

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ilaris 150 mg powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 150 mg of canakinumab*.
After reconstitution, each ml of solution contains 150 mg canakinumab.
* human monoclonal antibody produced in mouse myeloma Sp2/0 cells by
recombinant DNA
technology
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
The powder is white.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Periodic fever syndromes
Ilaris is indicated for the treatment of the following
autoinflammatory periodic fever syndromes in
adults, adolescents and children aged 2 years and older:
_Cryopyrin-associated periodic syndromes _
Ilaris is indicated for the treatment of cryopyrin-associated periodic
syndromes (CAPS) including:
•
Muckle-Wells syndrome (MWS),
•
Neonatal-onset multisystem inflammatory disease (NOMID) / chronic
infantile neurological,
cutaneous, articular syndrome (CINCA),
•
Severe forms of familial cold autoinflammatory syndrome (FCAS) /
familial cold urticaria
(FCU) presenting with signs and symptoms beyond cold-induced
urticarial skin rash.
_Tumour necrosis factor receptor associated periodic syndrome (TRAPS)
_
Ilaris is indicated for the treatment of tumour necrosis factor (TNF)
receptor associated periodic
syndrome (TRAPS).
_Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency
(MKD) _
Ilaris is indicated for the treatment of hyperimmunoglobulin D
syndrome (HIDS)/mevalonate kinase
deficiency (MKD).
_Familial Mediterranean fever (FMF) _
Ilaris is indicated for the treatment of Familial Mediterranean Fever
(FMF). Ilaris should be given in
combination with colchicine, if appropriate.
3
Ilaris is also indicated for the treatment of:
Still’s disease
Ilaris is indicated for the treatment of active Still’s disease
including adult-onset Still’s disease
(AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients
aged 2 years