HYRIMOZ

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ADALIMUMAB

متاح من:

NOVARTIS ISRAEL LTD

ATC رمز:

L04AB04

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

ADALIMUMAB 50 MG/ML

طريقة التعاطي:

S.C

نوع الوصفة الطبية :

Required

المصنعة من قبل:

SANDOZ GMBH SCHAFTENAU, AUSTRIA

المجال العلاجي:

ADALIMUMAB

الخصائص العلاجية:

Rheumatoid arthritis Hyrimoz in combination with methotrexate is indicated for:  The treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. The treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Hyrimoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate. Juvenile idiopathic arthritisPolyarticular juvenile idiopathic arthritis:Hyrimoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Hyrimoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate . Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis:Hyrimoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapyAxial spondyloarthritisAnkylosing spondylitis (AS): Hyrimoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Axial spondyloarthritis without radiographic evidence of AS: Hyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS, but with objective signs of inflammation by radiological and/or laboratory tests including MRI and serum CRP levels , who have had an inadequate response to, or are intolerant to, non - steroidal anti-inflammatory drugs. Psoriatic arthritis Hyrimoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Psoriasis Hyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. Paediatric plaque psoriasis Hyrimoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.Hidradenitis suppurativa (HS)Hyrimoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. Crohn’s disease Hyrimoz is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Hyrimoz is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.Paediatric Crohn's disease Hyrimoz is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6- years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and corticosteroid, and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies Ulcerative colitis Hyrimoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6- mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.Paediatric ulcerative colitis Hyrimoz is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.Uveitis Hyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.Paediatric Uveitis Hyrimoz is indicated for the treatment of chronic non-infectious uveitis in paediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.Intestinal Behcet’s diseaseHyrimoz is indicated for the treatment of intestinal Behcet’s disease in patients who have had an inadequate response to conventional therapy.

تاريخ الترخيص:

2020-06-07

نشرة المعلومات

HYRIMOZ
PATIENT SAFETY INFORMATION CARD
זומירייה
לפוטמל יתוחיטב עדימ סיטרכ
באמומילאדא זומירייה
החגשהב םיברועמה יאופרה תווצה ישנא
רובעו ךרובע עדימ
.ךב לופיטב וא תיאופרה
.הז סיטרכב תונייוצמ תוירשפאה יאוולה
תועפות לכ אל
חחושל וא רישכתב שומישה תליחת םרטב
ןכרצל ןולעב ןייעל שי
.יאוולה תועפות לע ףסונ עדימ לבקל ידכ
,ךלש אפורה םע תעדל ךילעש בושחו רחבנ יתוחיטב עדימ
ליכמ הז סיטרכ
זומירייהב לופיטה ךלהמבו ינפל
תקירז רחאל םימי 70 ךשמלו תע לכב ךתיא הז
סיטרכ רומש
ךלש הנורחאה זומירייהה
ותיא יאופר עוצקמ שיא וא אפור לכ ינפב הז
סיטרכ גצה
שגפנ התא
בג לע תרבעש תפחשל לופיט וא הקידב לכ
תודוא עדימ דעת
הז סיטרכ
המדקה
תומיוסמ תולחמב לופיטל תדעוימה הפורת
הניה זומירייה
.תינוסיחה תכרעמהמ קלח לע תועיפשמה
קלחב ,ולא תולחמב לופיטב הליעי תויהל
הלוכי זומירייהש דועב
בושח .רתוי וא תחא יאוול תעפות עיפוהל
הלולע םישנאהמ
תועפות לעו םיירשפאה תונורתיה לע ךלש
אפורה םע חחושתש
תונוש תויהל תויושע ולא .זומירייה
תליטנב תוירשפאה יאוולה
.םדאל םדאמ
תועפות רפסמ יבגל ךתוא עדייל איה הז
סיטרכ לש ותרטמ
זומירייה לש תוירשפאה יאוולה
תוללוכ שחרתהל תולולעש תורומחה יאוולה
תועפותמ קלח
םיבצעה תכרעמב תויעבו ןטרס ,םימוהיז
זומירייה לש תוירשפאה יאוולה תועפות לכ
ןניא ולא זומירייהב לופיטה ינפל
הפ�

خصائص المنتج

1.
NAME OF THE MEDICINAL PRODUCT
Hyrimoz 20 mg solution for injection in pre-filled syringe
Hyrimoz 40 mg solution for injection in pre-filled syringe
Hyrimoz 40 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hyrimoz 20 mg solution for injection in pre-filled syringe:
Each 0.4 ml single-dose pre-filled syringe contains 20 mg of
adalimumab.
Hyrimoz 40 mg solution for injection in pre-filled syringe:
Each 0.8 ml single-dose pre-filled syringe contains 40 mg of
adalimumab.
Hyrimoz 40 mg solution for injection in pre-filled pen:
Each 0.8 ml single-dose pre-filled pen contains 40 mg of adalimumab.
Adalimumab is a recombinant human monoclonal antibody produced in
Chinese Hamster Ovary cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear to slightly opalescent, colourless to slightly yellowish
solution.
Hyrimoz
®
is a biosimilar medicinal product that has been demonstrated to be
similar in quality, safety
and efficacy to the reference medicinal product Humira. 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/Biosimilars.aspx
4.
CLINICAL PARTICULARS
PATIENT SAFETY INFORMATION CARD
The marketing of Hyrimoz is subject to a risk management plan (RMP)
including 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.
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Hyrimoz in combination with methotrexate, is indicated for:
•
the treatment of