Byooviz

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Active ingredient:

ranibizumab

Available from:

Samsung Bioepis NL B.V.

ATC code:

S01LA04

INN (International Name):

ranibizumab

Therapeutic group:

Oftalmologi

Therapeutic area:

Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative

Therapeutic indications:

Byooviz is indicated in adults for:The treatment of neovascular (wet) age-related macular degeneration (AMD)The treatment of visual impairment due to diabetic macular oedema (DME)The treatment of proliferative diabetic retinopathy (PDR)The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)The treatment of visual impairment due to choroidal neovascularisation (CNV).

Product summary:

Revision: 6

Authorization status:

Pooblaščeni

Authorization date:

2021-08-18

Patient Information leaflet

                                34
Uporabno do
Shranjujte v hladilniku (2 °C – 8 °C). Ne zamrzujte.
Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred
svetlobo.
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
Nizozemska
EU/1/21/1572/001
Številka serije
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
13.
ŠTEVILKA SERIJE
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
35
PC
SN
NN
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
36
Byooviz 10 mg/ml
injekcija
ranibizumab
intravitrealna uporaba
EXP
Lot
2,3 mg/0,23 ml
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
NALEPKA
VIALA
1.
IME ZDRAVILA IN POT(I) UPORABE
2.
POSTOPEK UPORABE
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
4.
ŠTEVILKA SERIJE
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
6.
DRUGI PODATKI
37
PODATKI NA ZUNANJI OVOJNINI
ŠKATLA
VIALA
1.
IME ZDRAVILA
Byooviz 10 mg/ml raztopina za injiciranje
ranibizumab
2,3 mg/0,23 ml
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
En ml vsebuje 10 mg ranibizumaba. Ena viala vsebuje 2,3 mg
ranibizumaba v 0,23 ml raztopine.
3.
SEZNAM POMOŽNIH SNOVI
Vsebuje tudi: α,α-trehalozo dihidrat; histidinijev klorid
monohidrat; histidin; polisorbat 20; vodo za
injekcije.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
raztopina za injiciranje
1 x 0,23 ml viala (2,3 mg)
Enkraten odmerek za odrasle: 0,5 mg/0,05 ml. Pred injiciranjem je
treba iztisniti presežni volumen.
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Pred uporabo preberite priloženo navodilo!
intravitrealna uporaba.
Viala samo za enkratno uporabo.
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
Za to zdravilo se izvaja dodatno spremljanje varnosti. Tako bodo
hitreje na voljo nove informacije o
njegovi varnosti. Zdravstvene delavce naprošamo, da poročajo o
katerem koli domnevnem neželenem učinku
zdravila. Glejte poglavje 4.8, kako poročati o neželenih učinkih.
1.
IME ZDRAVILA
Byooviz 10 mg/ml raztopina za injiciranje
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
En mililiter vsebuje 10 mg ranibizumaba*. Ena viala vsebuje 2,3 mg
ranibizumaba v 0,23 ml raztopine. Ta
količina zadošča za injiciranje enkratnega odmerka 0,05 ml, ki
vsebuje 0,5 mg ranibizumaba, za odrasle.
*Ranibizumab je fragment humaniziranega monoklonskega protitelesa,
pridobljen iz celic bakterije
_ _
_Escherichia coli _
s tehnologijo rekombinantne DNA.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
raztopina za injiciranje
bistra, brezbarvna do bledo rumena vodna raztopina
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo Byooviz je indicirano pri odraslih:
•
za zdravljenje neovaskularne (vlažne) oblike starostne degeneracije
makule (AMD - age-related
macular degeneration),
•
za zdravljenje okvare vida zaradi diabetičnega makularnega edema
(DME),
•
za zdravljenje proliferativne diabetične retinopatije (PDR),
•
za zdravljenje okvare vida zaradi makularnega edema, ki nastane kot
posledica zapore mrežnične
vene (pri zapori centralne mrežnične vene ali njene veje) (RVO -
retinal vein occlusion),
•
za zdravljenje okvare vida zaradi horoidalne neovaskularizacije (CNV -
choroidal
neovascularisation).
4.2
ODMERJANJE IN NAČIN UPORABE
Zdravilo Byooviz sme aplicirati samo specialist oftalmolog, ki ima
izkušnje z intravitrealnimi injekcijami.
Odmerjanje
_Odrasli _
Priporočeni odmerek zdravila Byooviz za odrasle je 0,5 mg, kar bolnik
prejme z eno intravitrealno injekcijo
in ustreza injekcijskemu volumnu 0,05 ml. Med injiciranjem dveh
odmerkov v isto oko mora preteči najmanj
štiri tedne.
Odrasel bolnik prejema sprva eno injekcijo na mesec, d
                                
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Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 11-01-2024
Summary of Product characteristics Summary of Product characteristics Bulgarian 11-01-2024
Public Assessment Report Public Assessment Report Bulgarian 08-09-2021
Patient Information leaflet Patient Information leaflet Spanish 11-01-2024
Public Assessment Report Public Assessment Report Spanish 08-09-2021
Patient Information leaflet Patient Information leaflet Czech 11-01-2024
Public Assessment Report Public Assessment Report Czech 08-09-2021
Patient Information leaflet Patient Information leaflet Danish 11-01-2024
Public Assessment Report Public Assessment Report Danish 08-09-2021
Patient Information leaflet Patient Information leaflet German 11-01-2024
Public Assessment Report Public Assessment Report German 08-09-2021
Patient Information leaflet Patient Information leaflet Estonian 11-01-2024
Public Assessment Report Public Assessment Report Estonian 08-09-2021
Patient Information leaflet Patient Information leaflet Greek 11-01-2024
Public Assessment Report Public Assessment Report Greek 08-09-2021
Patient Information leaflet Patient Information leaflet English 11-01-2024
Public Assessment Report Public Assessment Report English 08-09-2021
Patient Information leaflet Patient Information leaflet French 11-01-2024
Public Assessment Report Public Assessment Report French 08-09-2021
Patient Information leaflet Patient Information leaflet Italian 11-01-2024
Public Assessment Report Public Assessment Report Italian 08-09-2021
Patient Information leaflet Patient Information leaflet Latvian 11-01-2024
Public Assessment Report Public Assessment Report Latvian 08-09-2021
Patient Information leaflet Patient Information leaflet Lithuanian 11-01-2024
Summary of Product characteristics Summary of Product characteristics Lithuanian 11-01-2024
Public Assessment Report Public Assessment Report Lithuanian 08-09-2021
Patient Information leaflet Patient Information leaflet Hungarian 11-01-2024
Summary of Product characteristics Summary of Product characteristics Hungarian 11-01-2024
Public Assessment Report Public Assessment Report Hungarian 08-09-2021
Patient Information leaflet Patient Information leaflet Maltese 11-01-2024
Public Assessment Report Public Assessment Report Maltese 08-09-2021
Patient Information leaflet Patient Information leaflet Dutch 11-01-2024
Public Assessment Report Public Assessment Report Dutch 08-09-2021
Patient Information leaflet Patient Information leaflet Polish 11-01-2024
Public Assessment Report Public Assessment Report Polish 08-09-2021
Patient Information leaflet Patient Information leaflet Portuguese 11-01-2024
Summary of Product characteristics Summary of Product characteristics Portuguese 11-01-2024
Public Assessment Report Public Assessment Report Portuguese 08-09-2021
Patient Information leaflet Patient Information leaflet Romanian 11-01-2024
Public Assessment Report Public Assessment Report Romanian 08-09-2021
Patient Information leaflet Patient Information leaflet Slovak 11-01-2024
Public Assessment Report Public Assessment Report Slovak 08-09-2021
Patient Information leaflet Patient Information leaflet Finnish 11-01-2024
Public Assessment Report Public Assessment Report Finnish 08-09-2021
Patient Information leaflet Patient Information leaflet Swedish 11-01-2024
Public Assessment Report Public Assessment Report Swedish 08-09-2021
Patient Information leaflet Patient Information leaflet Norwegian 11-01-2024
Summary of Product characteristics Summary of Product characteristics Norwegian 11-01-2024
Patient Information leaflet Patient Information leaflet Icelandic 11-01-2024
Summary of Product characteristics Summary of Product characteristics Icelandic 11-01-2024
Patient Information leaflet Patient Information leaflet Croatian 11-01-2024
Public Assessment Report Public Assessment Report Croatian 08-09-2021

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