ERELZI 25

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

ETANERCEPT

Disponibbli minn:

NOVARTIS ISRAEL LTD

Kodiċi ATC:

L04AB01

Għamla farmaċewtika:

SOLUTION FOR INJECTION

Kompożizzjoni:

ETANERCEPT 25 MG / 0.5 ML

Rotta amministrattiva:

S.C

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

SANDOZ GMBH SCHAFTENAU, AUSTRIA

Żona terapewtika:

ETANERCEPT

Indikazzjonijiet terapewtiċi:

Rheumatoid arthritisErelzi is indicated for the treatment of active rhematoid arthritis in adults when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate (unless contraindicated) has been inadequate. Erelzi can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. Reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis .Etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.Juvenile idiopathic arthritisTreatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Psoriatic arthritisTreatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.Axial spondyloarthritisAnkylosing spondylitis (AS)Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.Non-radiographic axial spondyloarthritisTreatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs).Plaque psoriasisTreatment of adults patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Paediatric plaque psoriasisTreatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Data ta 'l-awtorizzazzjoni:

2019-12-30

Fuljett ta 'informazzjoni

ת/לפוטמל סיטרכ יזלרא תלחתה ינפל הפורתה תוחיטב לע תעדל שיש
עדימ ליכמ הז סיטרכ .יזלראב לופיטה ךלהמבו יזלראב לופיטה .לפטמה אפורהמ רבסה שקבל שי ,ןבומ וניא
עדימה םא
•
.ךב לופיטב ברועמה אפור לכ ינפב הז סיטרכ
גיצהל שי
•
. ףסונ עדימ תלבקל יזלרא לש ןכרצל ןולעב
ןייעל שי ןורחאה לופיטה רחאל םיישדוח ךשמל הז
סיטרכ רומשל שי לופיטה רחאל יאוול תועפות עיפוהל
תולולעש רחאמ ,יזלראב .יזלראב ןורחאה
,ךביל תמושתל
• ,תחקרמה תיבב הפורתה תא ת/לבקמ ה/תאש םעפ
לכבש בושח אפורה ךל םשרש הפורתה התוא תא ת/לבקמ
ה/תאש י/אדוות וזמ הנוש תיארנ תלביקש הפורתה םא .ךב
לפטמה החמומה ,ונתשה שומישה תויחנהש וא ,ללכ ךרדב
ת/לבקמ ה/תאש .הנוכנה הפורתה תא תלביקש אדוול חקורל
דימ י/הנפ אנא טפסרנטא הליכמה הפורת לש ןונימ יוניש
וא הפלחה לכ החמומה אפורה ידי לע קרו ךא עצבתהל
םיבייח )ETANERCEPT)
.לפטמה אפורה ךל םשרש רישכתה לש ירחסמה ומש יכ
יקדב/קודב אנא
.חקורהמ תלביקש הפורתה םשל ההז וניה
,םשרמב החמומה
•
ירישכת לע ףסונ עדימל .ראלימיס-ויב
רישכת וניה יזלרא
תואירבה דרשמ רתאל תונפל שי ראלימיס-ויב
HTTPS://WWW.HEALTH.GOV.IL/UNITSOFFICE/HD/MTI/
DRUGS/REGISTRATION/PAGES/BIOSIMILARS.ASPX רפסמ תאו ירחסמה םשה תא לפטמה אפורה םע
דחיב דעתל בושח
.ךלש הפורתה לש הווצאה
______________________________________________
______________________________________________
םימוהיז
רשא ,םימוהיזב תולח�

Karatteristiċi tal-prodott

1.
NAME OF THE MEDICINAL PRODUCT
Erelzi
®
25 solution for injection in pre-filled syringe.
Erelzi
®
50 solution for injection in pre-filled syringe.
Erelzi
®
50 solution for injection in pre-filled pen.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Erelzi
®
25 solution for injection in pre-filled syringe
Each pre-filled syringe contains 25 mg of etanercept.
Erelzi
®
50 solution for injection in pre-filled syringe
Each pre-filled syringe contains 50 mg of etanercept.
Erelzi
®
50 solution for injection in pre-filled pen
Each pre-filled pen contains 50 mg of etanercept.
Etanercept is a human tumour necrosis factor receptor p75 Fc fusion
protein produced
by recombinant DNA technology in a Chinese hamster ovary (CHO)
mammalian
expression system.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is clear or slightly opalescent, colorless to slightly
yellowish.
Erelzi
®
is a biosimilar medicinal product that has been demonstrated to be
similar in
quality, safety and efficacy to the reference medicinal product
Enbrel. Please be aware
of any differences in the indications between the biosimilar medicinal
product and the
reference medicinal product. The biosimilar is not to be switched with
the reference
medicinal product unless specifically stated otherwise. More detailed
information
regarding biosimilar medicinal products is available on the website of
the Ministry of
Health:https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/Registration/Pages/Biosi
milars.aspx
PATIENT SAFETY INFORMATION CARD
The marketing of Erelzi
®
is subject to a risk management plan (RMP), which includes a
‘Patient
safety information card’. The ‘Patient safety information card’
emphasizes important safety
information that the patient should be aware of before and during
treatment. Please explain to the
patient the need to review the card before starting treatment.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Erelzi is indicated for the treatment of