Country: Kesatuan Eropah
Bahasa: Malta
Sumber: EMA (European Medicines Agency)
bevacizumab
Samsung Bioepis NL B.V.
L01FG01
bevacizumab
Aġenti antineoplastiċi
Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
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).
Revision: 7
Awtorizzat
2020-08-19
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 Baca dokumen lengkap
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 Baca dokumen lengkap