KEVZARA 200 MG

Страна: Израел

Език: английски

Източник: Ministry of Health

Активна съставка:

SARILUMAB

Предлага се от:

SANOFI ISRAEL LTD

АТС код:

L04AC14

Лекарствена форма:

SOLUTION FOR INJECTION

Композиция:

SARILUMAB 175 MG / 1 ML

Начин на приложение:

S.C

Вид предписание :

Required

Произведено от:

SANOFI-AVENTIS GROUPE, FRANCE

Терапевтична област:

SARILUMAB

Терапевтични показания:

Kevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.KEVZARA is indicated for treatment of adult patients with polymyalgia rheumatica who cannot tolerate corticosteroid taper

Дата Оторизация:

2023-03-31

Листовка

TECHNISCHE INFORMATION / TECHNICAL INFORMATION
SAP-Nr. / Plant PM code:
858007
Version:
1
Datum / Date:
08.07.2022 AR04
Abmessungen / Dimensions:
420 × 632 mm
DMC-Inhalt / DMC content:
858007
Seite / Page:
1/2
Kontur / Outline
Druckbare Farben / printing Colours:
Black
KEVZ-150 & 200-PIL-V5.0
858007
858007/2 םיחקורה תונקת יפל ןכרצל ןולע
1986 - ו"משתה )םירישכת(
יפ לע תקוושמ הפורתה
דבלב אפור םשרמ
ג"מ 150 הרזבק קרזמ/טעב הקרזהל הסימת
שומישל ןכומ ג"מ 200 הרזבק קרזמ/טעב הקרזהל הסימת
שומישל ןכומ :ליעפ רמוח
ןכומ קרזמ/טע לכ - ג"מ 150 הרזבק
ל"מ 1.14-ב באמולירס ג"מ 150 ליכמ שומישל
(Sarilumab 131.6 mg/ml)
ןכומ קרזמ/טע לכ - ג"מ 200 הרזבק
ל"מ 1.14-ב באמולירס ג"מ 200 ליכמ שומישל
(Sarilumab 175 mg/ml)
.6 ףיעס האר :םיליעפ יתלב םירמוח שמתשת םרטב ופוס דע ןולעה תא ןויעב ארק .הפורתב
.בוש וב אורקל ךרטצתו ןכתיי ,הז ןולע לע
רומש
ךל שי םא .הפורתה לע יתיצמת עדימ ליכמ הז
ןולע
.חקורה לא וא אפורה לא הנפ ,תופסונ תולאש
.םירחאל התוא ריבעת לא .ךרובע המשרנ וז
הפורת
םבצמ יכ ךל הארנ םא וליפא םהל קיזהל
הלולע איה
.המוד יאופרה עדימ סיטרכ םייק הרזבק רישכתל ,ןולעל
ףסונב יתוחיטב עדימ ליכמ הז סיטרכ .לפוטמל
יתוחיטב לופיטה תלחתה ינפל ,תעדל ךילעש ,בושח ןייעל שי .ויפ לע לועפלו הרזבקב לופיטה
ךלהמבו ןכרצל ןולעבו לפוטמל יתוחיטבה עדימה
סיטרכב תא רומשל שי .רישכתב שומישה תליחת םרטב
.
ךרוצה תדימב ףסונ ןויעל סיטרכה
?הרזבק תדעוימ המל .1
םיקרפ תקלד םע םירגו

Данни за продукта

1
KEVZ-150 & 200-SPC-V5.0
1.
NAME OF THE MEDICINAL PRODUCT
KEVZARA 150 MG
solution for injection in pre-filled syringe
KEVZARA 150 MG
solution for injection in pre-filled pen
KEVZARA 200 MG
solution for injection in pre-filled syringe
KEVZARA 200 MG
solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kevzara 150 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 150 mg sarilumab in 1.14 ml solution
(131.6 mg/ml).
Kevzara 150 mg solution for injection in pre-filled pen
Each pre-filled pen contains 150 mg sarilumab in 1.14 ml solution
(131.6 mg/ml).
Kevzara 200 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 200 mg sarilumab in 1.14 ml solution
(175 mg/ml).
Kevzara 200 mg solution for injection in pre-filled pen
Each pre-filled pen contains 200 mg sarilumab in 1.14 ml solution (175
mg/ml).
Sarilumab is a human monoclonal antibody produced in Chinese Hamster
Ovary cells by recombinant
DNA technology.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
Clear, colourless to pale yellow sterile solution of approximately pH
6.0.
4.
CLINICAL PARTICULARS
The marketing of Kevzara 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
Kevzara in combination with methotrexate (MTX) is indicated for the
treatment of moderately to
severely active rheumatoid arthritis (RA) in adult patients who have
responded inadequately to, or who
are intolerant to one or more disease modifying anti rheumatic drugs
(DMARDs). Kevzara can be
given as monotherapy in case of intolerance to MTX or when treatment
with MTX is inappropriate
(see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should