ILARIS 150 MGML SOLUTION FOR INJECTION

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

CANAKINUMAB

MAH:

NOVARTIS ISRAEL LTD

ATC_code:

L04AC08

pharmaceutical_form:

SOLUTION FOR INJECTION

composition:

CANAKINUMAB 150 MG / 1 ML

administration_route:

S.C

prescription_type:

Required

manufactured_by:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

therapeutic_area:

CANAKINUMAB

therapeutic_indication:

►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 Syndromes (CAPS)Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) in adults, adolescents and children aged 2 years and older with body weight of 7.5 kg or above, 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) in patients in whom colchicine is contraindicated, is not tolerated, or does not provide an adequate response despite the highest tolerable dose of colchicine.Ilaris can be given as monotherapy or in combination with colchicine.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

authorization_date:

2023-11-30

PIL

يبطلا مقاطلل لامعتسلإا تاميلعت
GIVING THE INJECTION
6. Choose an injection site on the upper thigh, abdomen, upper arm or
buttocks. Do not use an area
that has a rash or broken skin, or is bruised or lumpy. Do not inject
into scar tissue as this may mean
the patient does not get all of the medicine. Avoid injecting into a
vein.
7. Clean the injection site with a new alcohol swab. Allow the area to
dry. Uncap the injection needle.
Administer the injection.
8. Afterward, dispose of the needle and syringe in the sharps
container without recapping or removing
the needle.
AFTER THE INJECTION
9. If bleeding occurs, apply a clean, dry cotton swab over the area,
and press gently for 1 to 2 minutes,
or until bleeding stops. Then apply an adhesive bandage
10. Safely dispose of needles and syringe in the sharps container.
Never re-use syringes or needles.
11. Properly dispose of vials containing remaining Ilaris solution )if
any(.
Any unused product or waste material should be disposed of in
accordance
with local requirements. Never re-use the leftover solution.
Keep the sharps container out of reach of children.
Dispose by appropriate procedure in accordance with the local
requirements.
PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( - 1986
The medicine is dispensed with a doctor’s prescription only.
ILARIS 150 MG/ML
SOLUTION FOR INJECTION
ACTIVE INGREDIENT:
Each vial contains 150 mg Canakinumab in 1 mL solution.
Inactive and allergenic ingredients: see section 6 ”Further
Information“.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have
further questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it
on to others. It may harm them, even if it seems to you that their
medical
condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Ilaris contains the active substance canakinumab, a monoclonal
antib

SPC

ILR API Dec21 V4
Based on EU SmPC 28.09.2021
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 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 (CAPS) _
Ilaris is indicated for the treatment of cryopyrin-associated periodic
syndromes (CAPS) in adults,
adolescents and children aged 2 years and older with body weight of
7.5 kg or above, 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) in patients in whom colchicine
is contraindicated, is not tolerated, or does not provide an adequate
response despite the highest tolerable
dose of colchicine.
Ilaris can be given as monotherapy or in combination with colchicin