Aybintio

البلد: الاتحاد الأوروبي

اللغة: المالطية

المصدر: EMA (European Medicines Agency)

العنصر النشط:

bevacizumab

متاح من:

Samsung Bioepis NL B.V.

ATC رمز:

L01FG01

INN (الاسم الدولي):

bevacizumab

المجموعة العلاجية:

Aġenti antineoplastiċi

المجال العلاجي:

Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms

الخصائص العلاجية:

Aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. Għal aktar informazzjoni dwar l-istatus tal-fattur tat-tkabbir tal-epidermide tal-bniedem 2 (HER2), jekk jogħġbok irreferi għat-taqsima 5. 1 of the SmPC. Aybintio in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Aybintio in combination with capecitabine. Għal aktar informazzjoni dwar l-istatus ta 'HER2, jekk jogħġbok irreferi għat-taqsima 5. 1 of the SmPC. Aybintio, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Aybintio, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5. 1 of the SmPC). Aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Aybintio, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. 1 of the SmPC). Aybintio, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Aybintio, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents (see section 5. 1 of the SmPC). Aybintio, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5. 1 of the SmPC).

ملخص المنتج:

Revision: 7

الوضع إذن:

Awtorizzat

تاريخ الترخيص:

2020-08-19

نشرة المعلومات

65
B. FULJETT TA’ TAGĦRIF
66
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
AYBINTIO 25 MG/ML KONĊENTRAT GĦAL SOLUZZJONI GĦALL-INFUŻJONI
bevacizumab
Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Inti tista’ tgħin billi tirrapporta
kwalunkwe effett sekondarju li jista’ jkollok. Ara t-tmiem ta’
sezzjoni 4 biex tara kif għandek
tirrapporta effetti sekondarji.
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TUŻA DIN IL-MEDIĊINA
PERESS LI FIH INFORMAZZJONI
IMPORTANTI GĦALIK.
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib, lill-ispiżjar jew
lill-infermier tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib, lill-ispiżjar jew
lill-infermier tiegħek. Dan
jinkludi xi effett sekondarju possibbli li mhuwiex elenkat f’dan
il-fuljett. Ara sezzjoni 4.
F’DAN IL-FULJETT:
1.
X’inhu Aybintio u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tuża Aybintio
3.
Kif għandek tuża Aybintio
4.
Effetti sekondarji possibbli
5.
Kif taħżen Aybintio
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU AYBINTIO U GĦALXIEX JINTUŻA
Aybintio fih is-sustanza attiva bevacizumab, li hija antikorp
monoklonali umanizzat (tip ta’ proteina li
normalment tiġi magħmula mis-sistema immuni biex tgħin tiddefendi
lill-ġisem minn infezzjoni u
kanċer). Bevacizumab jingħaqad b’mod selettiv ma’ proteina
msejħa fattur tal-iżvilupp tal-endotelju
vaskulari uman (VEGF), li tinstab fuq il-kisja ta’ ġewwa ta’
vini/arterji tad-demm u tal-kanali tal-limfa
fil-ġisem. Il-proteina VEGF tikkawża l-iżvilupp ta’ kanali
tad-demm ġo tumuri; dawn il-kanali tad-
demm jipprovdu nutrijenti u ossiġnu lit-tumur. Kif bevacizumab
jingħaqad ma’ VEGF, it-tkabbir tat-
tumur jiġi mwaqqaf billi jimblokka l-iżvilupp tal-kanali tad-demm li
jipprovdu n-nutrijenti u l-ossiġnu
lit-tumur.
Aybintio huwa mediċina li tintuża

خصائص المنتج

1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Il-professjonisti tal-kura tas-saħħa
huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata. Ara
sezzjoni 4.8 dwar kif
għandhom jiġu rappurtati reazzjonijiet avversi.
1.
ISEM IL-PRODOTT MEDIĊINALI
Aybintio 25 mg/ml konċentrat għal soluzzjoni għall-infużjoni.
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
_ _
Kull ml ta’ konċentrat fih 25 mg ta’ bevacizumab*.
Kull kunjett ta’ 4 ml fih 100 mg ta’ bevacizumab.
Kull kunjett ta’ 16 ml fih 400 mg ta’ bevacizumab.
Għad-dilwizzjoni u rakkomandazzjonijiet oħra dwar l-immaniġġar,
ara sezzjoni 6.6.
*Bevacizumab huwa antikorp monoklonali rikombinanti umanizzat, prodott
permezz ta’ teknoloġija
ta’ DNA f’ċelluli tal-Ovarji tal-Ħamster Ċiniż.
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Konċentrat għal soluzzjoni għall-infużjoni (konċentrat sterili).
Likwidu ċar għal kemxejn ikanġi, bla kulur għal kannella ċar.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Aybintio flimkien ma’ kimoterapija bbażata fuq fluoropyrimidine
huwa indikat għat-trattament ta’
pazjenti adulti b’karċinoma metastatika tal-kolon jew tar-rektum.
Aybintio flimkien ma’ paclitaxel huwa indikat għat-trattament
primarju ta’ pazjenti adulti b’kanċer
metastatiku tas-sider. Għal aktar tagħrif dwar l-istat tar-riċettur
tal-fattur ta’ tkabbir epidermali
uman 2 (HER2 -
_human epidermal growth factor receptor 2_
), jekk jogħġbok irreferi għal sezzjoni 5.1.
Aybintio flimkien ma’ capecitabine huwa indikat għat-trattament
primarju ta’ pazjenti adulti b’kanċer
metastatiku tas-sider li għalihom trattament b’għażliet
kimoterapewtiċi oħra inklużi taxanes jew
anthracyclines mhuwiex ikkunsidrat xieraq. Pazjenti li rċevew
korsijiet li fihom taxane u anthracycline
f’ambjen