Vegzelma

Country: European Union

Language: Latvian

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
19-12-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
19-12-2023
Public Assessment Report Public Assessment Report (PAR)
07-09-2022

Active ingredient:

bevacizumab

Available from:

Celltrion Healthcare Hungary Kft.

ATC code:

L01XC07

INN (International Name):

bevacizumab

Therapeutic group:

Antineoplastiski līdzekļi

Therapeutic area:

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

Therapeutic indications:

VEGZELMA in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. VEGZELMA in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. Papildinformāciju par cilvēka epidermas augšanas faktora 2 receptora (HER2) statusu, lūdzu, skatiet 5. sadaļā. VEGZELMA 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 anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with VEGZELMA in combination with capecitabine. Sīkāku informāciju par HER2 statusu, lūdzu, skatiet 5. sadaļā. VEGZELMA, 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 (NSCLC) other than predominantly squamous cell histology. VEGZELMA, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent NSCLC with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5. VEGZELMA, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. VEGZELMA, 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. VEGZELMA, 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 vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor–targeted agents. VEGZELMA in combination with paclitaxel, 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. VEGZELMA, 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.

Product summary:

Revision: 4

Authorization status:

Autorizēts

Authorization date:

2022-08-17

Patient Information leaflet

                                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
VEGZELMA 25 mg/ml koncentratas infuziniam tirpalui
2.
KOKYBINĖ IR KIEKYBINĖ SUDĖTIS
Kiekviename koncentrato mililitre yra 25 mg bevacizumabo*.
Kiekviename 4 ml flakone yra 100 mg bevacizumabo.
Kiekviename 16 ml flakone yra 400 mg bevacizumabo.
Vaistinio preparato skiedimo ir ruošimo rekomendacijos pateikiamos
6.6 skyriuje.
*Bevacizumabas yra rekombinantinis humanizuotas monokloninis
antikūnas, pagamintas pagal
rekombinantinę DNR technologiją kininio žiurkėnuko 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
VEGZELMA derinant su chemoterapija, kurios pagrindas -
fluoropirimidino dariniai, skirta suaugusių
pacientų, sergančių metastazavusia gaubtinės arba tiesiosios
žarnos karcinoma, gydymui.
VEGZELMA derinant su paklitakseliu skirta kaip pirmojo pasirinkimo
vaistinio preparato suaugusių
pacientų, sergančių metastazavusiu krūties vėžiu, gydymui. Kita
informacija, pvz., apie žmogaus
epidermio augimo faktoriaus receptoriaus 2 (angl.
_human epidermal growth factor recepter 2 _
–
_HER2_
)
rodmenį, pateikiama 5.1 skyriuje.
VEGZELMA derinant su kapecitabinu skirta kaip pirmojo pasirinkimo
vaistinio preparato
metastazavusiu krūties vėžiu sergančius suaugusius pacientus,
kuriems kiti chemoterapijos vaistiniai
preparatai, įskaitant taksanus ir antraciklinus, laikomi netinkamais,
gydymui. Pacientams, kurie per
pastaruosius 12 mėnesių vartojo pagalbinę taksanų ir antraciklinų
darinių che
                                
                                Read the complete document

Summary of Product characteristics

                                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
VEGZELMA 25 mg/ml koncentratas infuziniam tirpalui
2.
KOKYBINĖ IR KIEKYBINĖ SUDĖTIS
Kiekviename koncentrato mililitre yra 25 mg bevacizumabo*.
Kiekviename 4 ml flakone yra 100 mg bevacizumabo.
Kiekviename 16 ml flakone yra 400 mg bevacizumabo.
Vaistinio preparato skiedimo ir ruošimo rekomendacijos pateikiamos
6.6 skyriuje.
*Bevacizumabas yra rekombinantinis humanizuotas monokloninis
antikūnas, pagamintas pagal
rekombinantinę DNR technologiją kininio žiurkėnuko 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
VEGZELMA derinant su chemoterapija, kurios pagrindas -
fluoropirimidino dariniai, skirta suaugusių
pacientų, sergančių metastazavusia gaubtinės arba tiesiosios
žarnos karcinoma, gydymui.
VEGZELMA derinant su paklitakseliu skirta kaip pirmojo pasirinkimo
vaistinio preparato suaugusių
pacientų, sergančių metastazavusiu krūties vėžiu, gydymui. Kita
informacija, pvz., apie žmogaus
epidermio augimo faktoriaus receptoriaus 2 (angl.
_human epidermal growth factor recepter 2 _
–
_HER2_
)
rodmenį, pateikiama 5.1 skyriuje.
VEGZELMA derinant su kapecitabinu skirta kaip pirmojo pasirinkimo
vaistinio preparato
metastazavusiu krūties vėžiu sergančius suaugusius pacientus,
kuriems kiti chemoterapijos vaistiniai
preparatai, įskaitant taksanus ir antraciklinus, laikomi netinkamais,
gydymui. Pacientams, kurie per
pastaruosius 12 mėnesių vartojo pagalbinę taksanų ir antraciklinų
darinių che
                                
                                Read the complete document

Similar products

Active ingredient bevacizumab

bevacizumab

ATC code L01XC07

L01XC07

Marketed by Celltrion Healthcare Hungary Kft.

Celltrion Healthcare Hungary Kft.

INN (International Name) bevacizumab

bevacizumab

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 19-12-2023
Summary of Product characteristics Summary of Product characteristics Bulgarian 19-12-2023
Public Assessment Report Public Assessment Report Bulgarian 07-09-2022
Patient Information leaflet Patient Information leaflet Spanish 19-12-2023
Summary of Product characteristics Summary of Product characteristics Spanish 19-12-2023
Public Assessment Report Public Assessment Report Spanish 07-09-2022
Patient Information leaflet Patient Information leaflet Czech 19-12-2023
Summary of Product characteristics Summary of Product characteristics Czech 19-12-2023
Public Assessment Report Public Assessment Report Czech 07-09-2022
Patient Information leaflet Patient Information leaflet Danish 19-12-2023
Summary of Product characteristics Summary of Product characteristics Danish 19-12-2023
Public Assessment Report Public Assessment Report Danish 07-09-2022
Patient Information leaflet Patient Information leaflet German 19-12-2023
Summary of Product characteristics Summary of Product characteristics German 19-12-2023
Public Assessment Report Public Assessment Report German 07-09-2022
Patient Information leaflet Patient Information leaflet Estonian 19-12-2023
Summary of Product characteristics Summary of Product characteristics Estonian 19-12-2023
Public Assessment Report Public Assessment Report Estonian 07-09-2022
Patient Information leaflet Patient Information leaflet Greek 19-12-2023
Summary of Product characteristics Summary of Product characteristics Greek 19-12-2023
Public Assessment Report Public Assessment Report Greek 07-09-2022
Patient Information leaflet Patient Information leaflet English 19-12-2023
Summary of Product characteristics Summary of Product characteristics English 19-12-2023
Public Assessment Report Public Assessment Report English 07-09-2022
Patient Information leaflet Patient Information leaflet French 19-12-2023
Summary of Product characteristics Summary of Product characteristics French 19-12-2023
Public Assessment Report Public Assessment Report French 07-09-2022
Patient Information leaflet Patient Information leaflet Italian 19-12-2023
Summary of Product characteristics Summary of Product characteristics Italian 19-12-2023
Public Assessment Report Public Assessment Report Italian 07-09-2022
Patient Information leaflet Patient Information leaflet Lithuanian 19-12-2023
Summary of Product characteristics Summary of Product characteristics Lithuanian 19-12-2023
Public Assessment Report Public Assessment Report Lithuanian 07-09-2022
Patient Information leaflet Patient Information leaflet Hungarian 12-09-2023
Summary of Product characteristics Summary of Product characteristics Hungarian 12-09-2023
Public Assessment Report Public Assessment Report Hungarian 07-09-2022
Patient Information leaflet Patient Information leaflet Maltese 19-12-2023
Summary of Product characteristics Summary of Product characteristics Maltese 19-12-2023
Public Assessment Report Public Assessment Report Maltese 07-09-2022
Patient Information leaflet Patient Information leaflet Dutch 19-12-2023
Summary of Product characteristics Summary of Product characteristics Dutch 19-12-2023
Public Assessment Report Public Assessment Report Dutch 07-09-2022
Patient Information leaflet Patient Information leaflet Polish 19-12-2023
Summary of Product characteristics Summary of Product characteristics Polish 19-12-2023
Public Assessment Report Public Assessment Report Polish 07-09-2022
Patient Information leaflet Patient Information leaflet Portuguese 19-12-2023
Summary of Product characteristics Summary of Product characteristics Portuguese 19-12-2023
Public Assessment Report Public Assessment Report Portuguese 07-09-2022
Patient Information leaflet Patient Information leaflet Romanian 19-12-2023
Summary of Product characteristics Summary of Product characteristics Romanian 19-12-2023
Public Assessment Report Public Assessment Report Romanian 07-09-2022
Patient Information leaflet Patient Information leaflet Slovak 19-12-2023
Summary of Product characteristics Summary of Product characteristics Slovak 19-12-2023
Public Assessment Report Public Assessment Report Slovak 07-09-2022
Patient Information leaflet Patient Information leaflet Slovenian 19-12-2023
Summary of Product characteristics Summary of Product characteristics Slovenian 19-12-2023
Public Assessment Report Public Assessment Report Slovenian 07-09-2022
Patient Information leaflet Patient Information leaflet Finnish 19-12-2023
Summary of Product characteristics Summary of Product characteristics Finnish 19-12-2023
Public Assessment Report Public Assessment Report Finnish 07-09-2022
Patient Information leaflet Patient Information leaflet Swedish 19-12-2023
Summary of Product characteristics Summary of Product characteristics Swedish 19-12-2023
Public Assessment Report Public Assessment Report Swedish 07-09-2022
Patient Information leaflet Patient Information leaflet Norwegian 19-12-2023
Summary of Product characteristics Summary of Product characteristics Norwegian 19-12-2023
Patient Information leaflet Patient Information leaflet Icelandic 19-12-2023
Summary of Product characteristics Summary of Product characteristics Icelandic 19-12-2023
Patient Information leaflet Patient Information leaflet Croatian 19-12-2023
Summary of Product characteristics Summary of Product characteristics Croatian 19-12-2023
Public Assessment Report Public Assessment Report Croatian 07-09-2022

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