ILARIS 150 MGML

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

CANAKINUMAB

Dostupné s:

NOVARTIS ISRAEL LTD

ATC kód:

L04AC08

Léková forma:

POWDER FOR SOLUTION FOR INJECTION

Složení:

CANAKINUMAB 150 MG / 1 ML

Podání:

S.C

Druh předpisu:

Required

Výrobce:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Terapeutické skupiny:

CANAKINUMAB

Terapeutické oblasti:

CANAKINUMAB

Terapeutické indikace:

►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 i

Datum autorizace:

2015-09-30

Informace pro uživatele

1
ךיראת 25.10.2016:
תילגנאב רישכת םש
:
ILARIS 150MG/ML רפסמ
ה
:םושיר [1446032964]
:םושירה לעב םש
סיטרבונ
מ"עב ,לארשי
!דבלב תורמחהה טוריפל דעוימ הז ספוט
רוחש טסקט
בוהצב עובצ וניאש
–
רשואמ טסקט
םויכ
ףלחומו
הצוח וק םע טסקט
–
רשואמה ןולעהמ טסקט תקיחמ
והצב ןמוסמה טסקט
ב
–
ו תפסות
הרמחה
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
INDICATION
CONTRAINDICATIONS
POSOLOGY& METHOD OF ADMINISTRATION
ADDITION:
TO
_TRAPS, HIDS/MKD and FMF: Adults, _
_adolescents and children aged 2 years and _
_older………_
Continued treatment with Ilaris in patients
without clinical improvement should be
reconsidered by the treating physician.
ADDITION:
TO
_SJIA _
Continued treatment with Ilaris in patients
without clinical improvement should be
reconsidered by the treating physician.
SPECIAL WARNINGS AND
PRECAUTIONS FOR USE
4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR
USE
Infections
Ilaris is associated with an
increased incidence of serious
infections. Physicians should
exercise caution when
administering Ilaris to patients
with infections, a history of
recurring infections or
underlying conditions which
may predispose them to
infections.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR
USE
Infections
Ilaris is associated with an increased incidence
of serious infections. Therefore patients
should be monitored carefully for signs and
symptoms of infections during and after
treatment with Ilaris. Physicians should
exercise caution when administering Ilaris to
patients with infections, a history of recurring
infections or underlying conditions which
may predispose them to infections.
2
NEUTROPENIA
Neutropenia (absolute
neutrophil count [ANC] < 1.5 x
10
9
/L) has been observed
commonly with another
medicinal product that inhibits
IL-1 used in a patient
population (rheumatoid
arthritis) other than CAPS.
Neutropenia was observed

Charakteristika produktu

ILA API MAR17 CL V6 EMA SmPC Approved 23.2.2017
_The format of this leaflet was determined by the Ministry of Health
and its content was checked and approved in March 2017_
1.
NAME OF THE MEDICINAL PRODUCT
ILARIS
®
150 mg/mL
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.
Each vial contains 92.35 mg of sucrose.
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
P