Ilaris 150mg1ml solution for injection vials

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Canakinumab

Tilgængelig fra:

Novartis Pharmaceuticals UK Ltd

ATC-kode:

L04AC08

INN (International Name):

Canakinumab

Dosering:

150mg/1ml

Lægemiddelform:

Solution for injection

Indgivelsesvej:

Subcutaneous

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: ; GTIN: 5010678909036

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
ILARIS
® 150 MG/ML 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.
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:

Muckle-Wells syndrome (MWS),

Produktets egenskaber

OBJECT 1
ILARIS 150MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 30-Apr-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Ilaris
®
150 mg/ml solution for injection
2. Qualitative and quantitative composition
One vial contains 150 mg of canakinumab*.
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
Solution for injection.
The solution is clear to opalescent and colourless to slightly
brownish yellow.
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.
Ilaris is also indicated for the treatment of:
Still's disease
Ilaris is indicated for the treatment of active Still's disease
including adult-