Aybintio

Țară: Uniunea Europeană

Limbă: lituaniană

Sursă: EMA (European Medicines Agency)

Prospect Prospect (PIL)
11-04-2023

Ingredient activ:

bevacizumabas

Disponibil de la:

Samsung Bioepis NL B.V.

Codul ATC:

L01FG01

INN (nume internaţional):

bevacizumab

Grupul Terapeutică:

Antinavikiniai vaistai

Zonă Terapeutică:

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

Indicații terapeutice:

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. Daugiau informacijos apie žmogaus epidermio augimo faktoriaus receptorių 2 (HER2) būklę rasite 5 skyriuje. 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. Daugiau informacijos apie HER2 statusą rasite 5 skyriuje. 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).

Rezumat produs:

Revision: 7

Statutul autorizaţiei:

Įgaliotas

Data de autorizare:

2020-08-19

Prospect

                                63
INFORMACIJA ANT IŠORINĖS
PAKUOTĖS
DĖŽUTĖ
1.
VAISTINIO PREPARATO PAVADINIMAS
Aybintio 25 mg/ml koncentratas infuziniam tirpalui
bevacizumabas
2.
VEIKLIOJI (-IOS) MEDŽIAGA (-OS) IR JOS (-Ų) KIEKIS (-IAI)
Kiekviename flakone yra 100 mg bevacizumabo.
3.
PAGALBINIŲ MEDŽIAGŲ SĄRAŠAS
Trehalozė dihidratas, natrio acetatas trihidratas, acto rūgštis,
polisorbatas 20, injekcinis vanduo.
4.
FARMACINĖ FORMA IR KIEKIS PAKUOTĖJE
Koncentratas infuziniam tirpalui
1 flakone yra 4 ml koncentrato
100 mg/4 ml
5.
VARTOJIMO METODAS IR BŪDAS (-AI)
Praskiedus leisti į veną
Prieš vartojimą perskaitykite pakuotės lapelį.
6.
SPECIALUS ĮSPĖJIMAS
,
KAD VAISTINĮ PREPARATĄ BŪTINA LAIKYTI
VAIKAMS NEPASTEBIMOJE IR NEPASIEKIAMOJE VIETOJE
Laikyti vaikams nepastebimoje ir nepasiekiamoje vietoje.
7.
KITAS (-I) SPECIALUS (-ŪS) ĮSPĖJIMAS (-AI) (JEI REIKIA)
8.
TINKAMUMO LAIKAS
Tinka iki
9.
SPECIALIOS LAIKYMO SĄLYGOS
Laikyti šaldytuve.
Negalima užšaldyti.
Flakoną laikyti išorinėje dėžutėje.
64
10.
SPECIALIOS ATSARGUMO PRIEMONĖS DĖL NESUVARTOTO VAISTINIO
PREPARATO AR JO ATLIEKŲ
TVARKYMO (JEI REIKIA)
11.
REGISTRUOTOJO PAVADINIMAS IR ADRESAS
Samsung Bioepis NL B.V.
Olof Palmestraat 10, 2616 LR Delft
Nyderlandai
12.
REGISTRACIJOS PAŽYMĖJIMO NUMERIS (-IAI)
EU/1/20/1454/001
13.
SERIJOS NUMERIS
Serija
14.
PARDAVIMO (IŠDAVIMO) TVARKA
15.
VARTOJIMO INSTRUKCIJA
16.
INFORMACIJA BRAILIO RAŠTU
Priimtas pagrindimas informacijos Brailio raštu nepateikti.
17.
UNIKALUS IDENTIFIKATORIUS – 2D BRŪKŠNINIS KODAS
2D brūkšninis kodas su nurodytu unikaliu identifikatoriumi.
18.
UNIKALUS IDENTIFIKATORIUS – ŽMONĖMS SUPRANTAMI DUOMENYS
PC
SN
NN
65
MINIMALI INFORMACIJA ANT MAŽŲ VIDINIŲ
PAKUOČIŲ
FLAKONAS
1.
VAISTINIO PREPARATO PAVADINIMAS IR VARTOJIMO BŪDAS (-AI)
Aybintio 25 mg/ml sterilus koncentratas
bevacizumabas
Praskiedus i.v.
2.
VARTOJIMO METODAS
3.
TINKAMUMO LAIKAS
EXP
4.
SERIJOS NUMERIS
Lot
5.
KIEKIS (MASĖ, TŪRIS ARBA VIENETAI)
100 mg/4 ml
6.
KITA
66
INFORMACIJA ANT IŠORINĖS PAKUOTĖS
DĖŽUTĖ
1.
VAIST
                                
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Caracteristicilor produsului

                                1
I PRIEDAS
PREPARATO CHARAKTERISTIKŲ SANTRAUKA
2
Vykdoma papildoma šio vaistinio preparato stebėsena. Tai padės
greitai nustatyti naują saugumo
informaciją. Sveikatos priežiūros specialistai turi pranešti apie
bet kokias įtariamas nepageidaujamas
reakcijas. Apie tai, kaip pranešti apie nepageidaujamas reakcijas,
žr. 4.8 skyriuje.
1.
VAISTINIO PREPARATO PAVADINIMAS
Aybintio 25 mg/ml koncentratas infuziniam tirpalui
2.
KOKYBINĖ IR KIEKYBINĖ SUDĖTIS
Kiekviename koncentrato mililitre yra 25 mg bevacizumabo*.
Kiekviename 4 ml tūrio flakone yra 100 mg bevacizumabo.
Kiekviename 16 ml tūrio flakone yra 400 mg bevacizumabo.
Vaistinio preparato skiedimo ir ruošimo rekomendacijos pateikiamos
6.6 skyriuje.
*Bevacizumabas yra rekombinantinis humanizuotas monokloninis
antikūnas, pagamintas
rekombinantinės DNR technologijos būdu kininio žiurkėno
kiaušidžių ląstelėse.
Visos pagalbinės medžiagos išvardytos 6.1 skyriuje.
3.
FARMACINĖ FORMA
Koncentratas infuziniam tirpalui (sterilus koncentratas).
Skaidrus ar šiek tiek opalescuojantis, bespalvis ar rusvas skystis.
4.
KLINIKINĖ INFORMACIJA
4.1
TERAPINĖS INDIKACIJOS
Aybintio derinant su chemoterapija, kurios pagrindas -
fluoropirimidino dariniai, skiriama
suaugusiems pacientams, sergantiems metastazavusia gaubtinės arba
tiesiosios žarnos karcinoma,
gydyti.
Aybintio derinant su paklitakseliu skiriama kaip pirmojo pasirinkimo
vaistinio preparato suaugusiems
pacientams, sergantiems metastazavusiu krūties vėžiu, gydyti. Kitos
informacijos, pvz., apie žmogaus
epidermio augimo faktoriaus receptoriaus 2 (angl.
_human epidermal growth factor recepter 2_
– HER2)
rodmenį, prašome žiūrėti 5.1 skyriuje.
Aybintio derinant su kapecitabinu skiriama kaip pirmojo pasirinkimo
vaistinio preparato gydyti
metastazavusiu krūties vėžiu sergančius suaugusius pacientus,
kuriems kiti chemoterapijos preparatai,
įskaitant taksanus ir antraciklinus, laikomi netinkamais. Pacientams,
kurie per pastaruosius 12 mėnesių
vartojo pagalbinę taksanų ir antraciklin
                                
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