FrancophonIA/ELRC3.0 huggingface dataset:
English: Two different pack types are available:
Slovenian: Na voljo sta dve različni vrsti pakiranja:
English: Date of first authorisation: 22 January 2007 Date of latest renewal: 11 November 2016
Slovenian: Datum prve odobritve: 22. januar 2007 Datum zadnjega podaljšanja: 11. november 2016
English: Re-use may lead to infection or other illness/injury.
Slovenian: Ponovna uporaba lahko povzroči okužbo ali druge bolezni/poškodbe.
English: This effect was maintained up to Month 24.
Slovenian: Ta učinek je ostal ohranjen do konca 24. meseca.
English: Make sure that the pack contains:
Slovenian: Prepričajte se, da pakiranje vsebuje:
English: • performed or planned intraocular surgery within the previous or next 28 days.
Slovenian: • izvedena ali načrtovana intraokularna operacija v predhodnih ali sledečih 28 dneh.
English: 2870 Puurs Belgium
Slovenian: 2870 Puurs Belgija
English: Systemic clearance was slightly lower, but this was not clinically significant.
Slovenian: Sistemski očistek je bil nekoliko nižji, vendar to ni imelo kliničnega pomena.
English: However, no special considerations are needed in this population.
Slovenian: Vendar za to skupino niso potrebna posebna opozorila.
English: The apparent systemic half-life was approximately 6 days.
Slovenian: Navidezni sistemski razpolovni čas je bil približno 6 dni.
English: Group III vPDT
Slovenian: skupina III vPDT
English: • Aggressive posterior (AP)-ROP
Slovenian: • agresivna posteriorna (AP)-ROP.
English: (maintenance of vision, primary endpoint)
Slovenian: (ohranitev vida, primarni cilj opazovanja)
English: 30-Jun-2020
Slovenian: 30. junij 2020
English: If this happens, do not drive or use machines until this resolves.
Slovenian: Če se to zgodi, ne vozite in ne upravljajte strojev, dokler te težave ne minejo.
English: Final study report:
Slovenian: Zaključno poročilo o študiji:
English: p<0.0001for both studies
Slovenian: p<0,0001 za obe študiji
English: • an intraocular pressure of ≥30 mmHg;
Slovenian: • intraokularni tlak ≥30 mmHg;
English: No carcinogenicity or mutagenicity data are available.
Slovenian: Podatki o kancerogenosti ali mutagenosti niso na voljo.
English: Some patients may only need one injection during the first 12 months; others may need more frequent treatment, including a monthly injection.
Slovenian: Nekateri bolniki bodo morda potrebovali samo eno injekcijo v prvih 12 mesecih, drugi pa bodo morda potrebovali pogostejše zdravljenje, lahko tudi injiciranje enkrat na mesec.
English: Treatment of PDR
Slovenian: Zdravljenje PDR
English: However, evidence of reversibility was observed after recovery.
Slovenian: Vendar so se po okrevanju pokazali znaki reverzibilnosti.
English: • the syringe is not damaged.
Slovenian: • da brizga ni poškodovana,
English: The administration of more than three injections per eye has not been studied.
Slovenian: Odmerjanja več kot treh injekcij na oko niso proučili.
English: • When to seek urgent attention from the health care provider
Slovenian: • v katerih primerih je treba poiskati urgentno zdravstveno pomoč
English: b p-value for pairwise comparison is one-sided.
Slovenian: Vrednost p za parne primerjave je enostranska.
English: Check that:
Slovenian: Prepričajte se:
English: It binds with high affinity to the VEGF-A isoforms (e.g. VEGF110, VEGF121 and VEGF165), thereby preventing binding of VEGF-A to its receptors VEGFR-1 and VEGFR-2.
Slovenian: Z visoko afiniteto se veže na izooblike VEGF-A (npr.VEGF110, VEGF121 in VEGF165) in tako preprečuje vezavo VEGF-A na njegove receptorje VEGFR-1 in VEGFR-2.
English: If any of the above is not true, discard the pre-filled syringe and use a new one.
Slovenian: Če karkoli od zgoraj navedenega ne drži, zavrzite napolnjeno injekcijsko brizgo in vzemite novo.
English: 30-Jun-2023
Slovenian: 30. junij 2023
English: The severity of the inflammatory response generally diminished with subsequent injections or during recovery.
Slovenian: Intenzivnost vnetnega odgovora se je večinoma zmanjšala z naslednjimi injiciranji ali med okrevanjem.
English: Microscopic ocular changes were related to inflammation and did not indicate degenerative processes.
Slovenian: Mikroskopske spremembe v očesu so bile povezane z vnetjem in niso nakazovale degenerativnih procesov.
English: The treatment is started with one injection of Lucentis per month.
Slovenian: Zdravljenje se začne z eno injekcijo zdravila Lucentis na mesec.
English: Following intravitreal administration, no signs of systemic toxicity were detected.
Slovenian: Po intravitrealnem apliciranju niso odkrili nobenih znakov sistemske toksičnosti.
English: Both intraocular pressure and the perfusion of the optic nerve head must be monitored and managed appropriately.
Slovenian: Tako intraokularni tlak kot tudi perfuzijo glave očesnega živca je treba spremljati in ustrezno obravnavati.
English: Women of childbearing potential should use effective contraception during treatment.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem.
English: These side effects may also occur in babies born prematurely.
Slovenian: Ti neželeni učinki se lahko pojavijo tudi pri prezgodaj rojenih otrocih.
English: In patients with wet AMD, DME, PDR and RVO, initially, three or more consecutive, monthly injections may be needed.
Slovenian: Pri bolnikih s SDM, DME, PDR in RVO so na začetku lahko potrebne tri ali več zaporedne mesečne aplikacije.
English: Detailed instructions for use are given at the end of the leaflet under “How to prepare and administer Lucentis”.
Slovenian: Podrobna navodila za uporabo so opisana na koncu teh navodil pod naslovom “Kako pripraviti in aplicirati zdravilo Lucentis”.
English: 9.5 letters
Slovenian: 9,5 črke
English: Pregnancy and breast-feeding - Women who could become pregnant must use effective contraception during treatment and for at least three further months after the last injection of Lucentis.
Slovenian: Nosečnost in dojenje - Ženske, ki lahko zanosijo, morajo uporabljati učinkovito kontracepcijo v času zdravljenja in še najmanj tri mesece po zadnji injekciji zdravila Lucentis.
English: If you are pregnant, think you may be pregnant or planning to become pregnant, discuss this with your doctor before treatment with Lucentis.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se o tem pogovorite z zdravnikom pred zdravljenjem z zdravilom Lucentis.
English: In the 26-week study, the severity of the vitreous inflammation increased with the number of injections.
Slovenian: V 26-tedenski študiji je intenzivnost vnetja v steklovini naraščala s številom injekcij.
English: These posterior segment changes diminished, and in some instances resolved, during the recovery period.
Slovenian: Te spremembe v zadajšnjem segmentu so se v obdobju okrevanja zmanjšale, v nekaterih primerih pa so povsem izginile.
English: The treatment is started with one injection of Lucentis in each eye (some babies may only need treatment in one eye).
Slovenian: Zdravljenje se začne z eno injekcijo zdravila Lucentis v posamezno oko (nekateri otroci potrebujejo zdravljenje samo v enem očesu).
English: 62.9% of Group II patients did not require injections in the second 6 months of the study.
Slovenian: 62,9 % bolnikov iz skupine II v drugem 6-mesečnem obdobju v študiji ni več potrebovalo injekcij.
English: Post-authorisation efficacy study (PAES): CRFB002H2301E1
Slovenian: Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES): CRFB002H2301E1
English: In these diseases, Lucentis can help to stabilise and in many cases improve your vision.
Slovenian: Pri navedenih boleznih lahko zdravilo Lucentis prispeva k stabilizaciji in v veliko primerih k izboljšanju vida.
English: In addition, patients should be monitored during the week following the injection to permit early treatment if an infection occurs.
Slovenian: Razen tega je potrebno bolnike spremljati v tednu po injekciji, da bi lahko v primeru okužbe omogočili čimprejšnje zdravljenje.
English: The treatment of visual impairment due to CNV should be determined individually per patient based on disease activity.
Slovenian: Zdravljenje okvare vida zaradi CNV je treba določiti individualno za vsakega posameznega bolnika glede na aktivnost bolezni.
English: Patients who experience these signs must not drive or use machines until these temporary visual disturbances subside.
Slovenian: Bolniki, pri katerih pride do teh znakov, ne smejo voziti ali upravljati s stroji, dokler se te začasne motnje vida ne umirijo.
English: If disease activity recurs, the treatment interval should be shortened accordingly.
Slovenian: Če bolezen spet postane aktivna, je treba interval med odmerki temu primerno skrajšati.
English: Month 12 -10.5 (16.6) +7.2 (14.4) -9.5 (16.4) +11.3 (14.6) Month 24 -14.9 (18.7) +6.6 (16.5) -9.8 (17.6) +10.7 (16.5)
Slovenian: a po 12 mesecih -10,5 (16,6) +7,2 (14,4) -9,5 (16,4) +11,3 (14,6) po 24 mesecih -14,9 (18,7) +6,6 (16,5) -9,8 (17,6) +10,7 (16,5)
English: A total of 1,323 patients (879 active and 444 control) were enrolled in these studies.
Slovenian: Skupno so v te študije vključili 1.323 bolnikov (879 aktivnih in 444 kontrol).
English: For information on preparation of Lucentis, see section 6.6.
Slovenian: Za pripravo zdravila Lucentis glejte poglavje 6.6.
English: The warnings and precautions for adults also apply to preterm infants with ROP.
Slovenian: Opozorila in previdnostni ukrepi za odrasle veljajo tudi za nedonošenčke z ROP.
English: - In some patients the eye pressure may increase for a short period directly after the injection.
Slovenian: - Pri nekaterih bolnikih lahko pride do povišanja očesnega tlaka za kratek čas takoj po injiciranju.
English: Patients with active severe intraocular inflammation.
Slovenian: Bolniki z aktivnim hudim intraokularnim vnetjem.
English: No dose adjustment is required in the elderly.
Slovenian: Pri starejših prilagajanje odmerkov ni potrebno.
English: Caution should be exercised when treating such patients (see section 4.8).
Slovenian: Pri zdravljenju takih bolnikov je potrebna previdnost (glejte poglavje 4.8).
English: In addition the European Medicines Agency has waived the obligation to submit the results of studies with Lucentis in the following subsets of the paediatric population for ROP: term newborn infants, infants, children and adolescents.
Slovenian: Poleg tega je Evropska agencija za zdravila odstopila od zahteve za predložitev rezultatov študij z zdravilom Lucentis za naslednje podskupine pediatrične populacije za ROP: pri donošenih novorojenčkih, dojenčkih, otrocih in mladostnikih.
English: The doctor will also give your baby a local anaesthetic to reduce or prevent any pain.
Slovenian: Zdravnik bo vašemu otroku dal tudi lokalni anestetik, da bi zmanjšal oziroma preprečil bolečine.
English: Tell your baby's doctor if your baby is receiving, has recently received or might receive any other medicines.
Slovenian: Obvestite otrokovega zdravnika, če vaš otrok prejema, je pred kratkim prejel ali pa bo morda začel prejemati katero koli drugo zdravilo.
English: Patients should also be instructed to report if an intraocular inflammation increases in severity, which may be a clinical sign attributable to intraocular antibody formation.
Slovenian: Bolnikom je treba tudi naročiti, da sporočijo, če se intenzivnost intraokularnega vnetja stopnjuje, kar bi bil lahko klinični znak, ki ga je mogoče pripisati tvorbi intraokularnih protiteles.
English: Studies in cynomolgus monkeys do not indicate direct or indirect harmful effects with respect to pregnancy or embryonal/foetal development (see section 5.3).
Slovenian: Študije na opicah javanski makak ne kažejo neposrednih ali posrednih škodljivih učinkov v nosečnosti ali na razvoj zarodka/plodu (glejte poglavje 5.3).
English: The long-term safety profile in preterm infants has not been established.
Slovenian: Dolgoročnega varnostnega profila pri nedonošenčkih niso ugotavljali.
English: Dispose of the used syringe together with the needle in a sharps disposal container or in accordance with local requirements.
Slovenian: Uporabljeno brizgo skupaj z iglo zavrzite v zabojnik za ostre predmete oziroma v skladu z lokalnimi predpisi.
English: The effect of ranibizumab treatment was similar irrespective of the presence of retinal ischaemia.
Slovenian: Učinek zdravljenja z ranibizumabom je bil približno enak ne glede na prisotnost ishemije mrežnice.
English: All components are sterile.
Slovenian: Vse komponente so sterilne.
English: There are no data available on fertility.
Slovenian: O vplivu na plodnost ni na voljo nobenih podatkov.
English: 90429 Nuremberg
Slovenian: 90429 Nürnberg
English: Populations with limited data
Slovenian: Skupine bolnikov z omejeno količino podatkov
English: The opening of the sealed tray and all subsequent steps should be done under aseptic conditions.
Slovenian: Odpiranje pretisnega omota in vse nadaljnje korake je treba izvajati v aseptičnih pogojih.
English: The adverse reactions are listed by system organ class and frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti po naslednjem dogovoru: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: The following information is intended for healthcare professionals only:
Slovenian: NASLEDNJE INFORMACIJE SO NAMENJENE SAMO ZDRAVSTVENEMU OSEBJU:
English: Do not pull back on the plunger.
Slovenian: Bata ne vlecite nazaj.
English: Before the injection, your doctor will wash your eye carefully to prevent infection.
Slovenian: Pred injiciranjem bo zdravnik vaše oko pazljivo izpral, da bi preprečil okužbo.
English: The safety and efficacy of ranibizumab have not yet been established in paediatric patients.
Slovenian: Varnosti in učinkovitosti ranibizumaba pri pediatričnih bolnikih še nista bili dokazani.
English: DRSS = diabetic retinopathy severity score, n = number of patients who satisfied the condition at the visit, N = total number of study eyes.
Slovenian: DRSS = ocena izraženosti diabetične retinopatije (DRSS - diabetic retinopathy severity score), n = število bolnikov, ki so na obisku ustrezali danemu pogoju, N = skupno število študijskih oči
English: The excess volume should be expelled prior to injection.
Slovenian: Presežni volumen je treba iztisniti pred injiciranjem.
English: The nature and timing of the posterior segment inflammation is suggestive of an immune-mediated antibody response, which may be clinically irrelevant.
Slovenian: Narava in časovno pojavljanje vnetja zadajšnjega segmenta kažeta na imunsko posredovan odgovor protiteles, ki je morda klinično nepomemben.
English: This information will be taken into account to evaluate if Lucentis is the appropriate treatment for you.
Slovenian: Te podatke mora zdravnik upoštevati pri presoji, ali je zdravilo Lucentis primerno za vas.
English: • a decrease in best-corrected visual acuity (BCVA) of ≥30 letters compared with the last assessment of visual acuity;
Slovenian: • poslabšanje najboljše ostrine vida s korekcijo (BCVA - best-corrected visual acuity) za ≥30 črk v primerjavi z zadnjim določanjem ostrine vida;
English: Lucentis should not be used during pregnancy unless the potential benefit outweighs the potential risk to the unborn child.
Slovenian: Zdravila Lucentis se pri nosečnicah ne sme uporabljati, razen če možne koristi presegajo možna tveganja za nerojenega otroka.
English: With both TE regimens, more than 70% of patients maintained their BCVA with an average visit frequency of ≥2 months.
Slovenian: Pri obeh shemah odmerjanja “Zdravi in podaljšaj” je več kot 70 % bolnikov ohranilo svojo BCVA pri povprečni pogostnosti obiskov enkrat na ≥2 meseca.
English: For the treatment of babies born prematurely with retinopathy of prematurity (ROP) please see the other side of this leaflet.
Slovenian: Za zdravljenje prezgodaj rojenih otrok z retinopatijo nedonošenčkov (ROP) glejte drugo stran tega lista.
English: In the posterior segment, there were vitreal cell infiltration and floaters, which also tended to be dose-dependent and generally persisted to the end of the treatment period.
Slovenian: V zadajšnjem segmentu so bili prisotni celična infiltracija in delci v steklovini, ki so ravno tako kazali trend odvisnosti od velikosti odmerka in so večinoma vztrajali do konca obdobja zdravljenja.
English: If an overdose occurs, intraocular pressure should be monitored and treated, if deemed necessary by the attending physician.
Slovenian: Če pride do prevelikega odmerjanja, je treba meriti in uravnati intraokularni tlak, če se to zdi potrebno prisotnemu zdravniku.
English: The difference in least square means was 3.5 letters (95% CI: [0.2 to 6.7]).
Slovenian: Razlika po metodi najmanjših kvadratov je znašala 3,5 črke (95-odstotni IZ: [0,2 do 6,7]).
English: * observed only in DME population
Slovenian: * neželeni učinek so opažali samo v populaciji z DME
English: Intraocular pressure increases
Slovenian: Zvišanje intraokularnega tlaka
English: For PDR and RVO, treatment intervals may also be gradually extended, however there are insufficient data to conclude on the length of these intervals.
Slovenian: Za zdravljenje bolnikov s PDR in RVO se lahko intervali med posameznimi aplikacijami zdravila postopoma podaljšajo, vendar o dolžini teh intervalov ni zadostnih podatkov.
English: Protocol S was a multicentre, randomised, active-controlled, parallel-assignment, non-inferiority phase III study in which 305 patients (394 study eyes) with PDR with or without DME at baseline were enrolled.
Slovenian: Protocol S je bila multicentrična, randomizirana, aktivno kontrolirana študija faze III z vzporednima skupinama za ugotavljanje neinferiornosti, v katero so vključili 305 bolnikov (394 študijskih oči) s PDR in z DME ali brez njega ob izhodišču.
English: BABIES BORN PREMATURELY
Slovenian: PREZGODAJ ROJENI OTROCI (NEDONOŠENČKI)
English: For women who wish to become pregnant and have been treated with ranibizumab, it is recommended to wait at least 3 months after the last dose of ranibizumab before conceiving a child.
Slovenian: Za ženske, ki želijo zanositi in so se zdravile z ranibizumabom, je priporočeno, da po zadnjem odmerku ranibizumaba počakajo najmanj 3 mesece, preden zanosijo.
English: In the phase IIIb study D2304 (RETAIN), 372 patients were randomised in 1:1:1 ratio to receive:
Slovenian: V študiji faze IIIb z oznako D2304 (RETAIN) so 372 bolnikov randomizirali v razmerju 1:1:1 tako, da so prejemali:
English: Package leaflet: Information for guardians of babies born prematurely
Slovenian: Navodilo za uporabo: Informacije za skrbnike prezgodaj rojenih otrok
English: The efficacy and safety of Lucentis have been assessed in three randomised, controlled studies of at least 12 months duration.
Slovenian: Varnost in učinkovitost zdravila Lucentis so ocenjevali v treh randomiziranih, kontroliranih študijah s trajanjem najmanj 12 mesecev.
English: CI = confidence interval, M = total number of patients with non-missing value on primary efficacy outcome (including imputed values), n = number of patients with absence of active ROP and absence of unfavourable structural outcome in both eyes 24 weeks after the first study treatment (including imputed values).
Slovenian: IZ = interval zaupanja, M = skupno število bolnikov z nemanjkajočo vrednostjo primarnega cilja opazovanja (vključno z imputiranimi vrednostmi), n = število bolnikov z odsotno aktivno retinopatijo nedonošenčkov (ROP) in odsotnimi neugodnimi strukturnimi spremembami v obeh očesih 24 tednov po prvem študijskem zdravljenju (vključno z imputiranimi vrednostmi).
English: A PK/PD analysis showed no clear relationship between systemic ranibizumab concentrations and systemic VEGF concentrations.
Slovenian: Farmakokinetična/farmakodinamična analiza ni pokazala jasne povezanosti med sistemskimi koncentracijami ranibizumaba in sistemskimi koncentracijami VEGF.
English: Therefore, ranibizumab should not be used during pregnancy unless the expected benefit outweighs the potential risk to the foetus.
Slovenian: Zato se ranibizumaba ne sme uporabljati med nosečnostjo, razen če je pričakovana korist večja od možne nevarnosti za plod.
English: Monitoring for disease activity may include clinical examination, functional testing or imaging techniques (e.g. optical coherence tomography or fluorescein angiography).
Slovenian: Spremljanje aktivnosti bolezni lahko vključuje klinični pregled, preiskave vidne funkcije ali slikovne metode (na primer optično koherenčno tomografijo ali fluoresceinsko angiografijo).
English: This is observed in diseases such as age-related macular degeneration (AMD) and proliferative diabetic retinopathy (PDR, a disease caused by diabetes).
Slovenian: Ta pojav opažamo pri boleznih, kot sta starostna degeneracija makule (SDM) in proliferativna diabetična retinopatija (PDR, bolezen, ki jo povzroča sladkorna bolezen).
English: For other subscales of this questionnaire no treatment differences could be established.
Slovenian: Pri ostalih podlestvicah tega vprašalnika niso ugotovili razlik med posameznimi načini zdravljenja.
English: Your doctor will also give you a local anaesthetic to reduce or prevent any pain you might have with the injection.
Slovenian: Zdravnik vam bo dal tudi lokalni anestetik, da bi zmanjšal oziroma preprečil bolečino, ki bi jo lahko čutili pri injiciranju.
English: a p<0.00001 comparison with vPDT control b
Slovenian: a p<0,00001 za primerjavo s kontrolno skupino z vPDT
English: Concomitant use of other anti-VEGF (vascular endothelial growth factor)
Slovenian: Sočasna uporaba drugih zdravil, ki delujejo proti VEGF (vaskularnemu endotelijskemu rastnemu dejavniku)
English: Since there is a potential for an increased systemic exposure in subjects with DME, an increased risk for developing hypersensitivity in this patient population cannot be excluded.
Slovenian: Ker pri bolnikih z DME obstaja možnost povečane sistemske izpostavljenosti zdravilu, pri tej skupini bolnikov ni mogoče izključiti povečanega tveganja za razvoj preobčutljivosti.
English: This lack of information should be considered by the physician when treating such patients.
Slovenian: Pri zdravljenju takih bolnikov mora zdravnik upoštevati navedeno pomanjkanje podatkov.
English: Patients treated with Lucentis in PIER received a mean of 10 total treatments.
Slovenian: Bolniki, ki so prejemali zdravilo Lucentis v študiji PIER, so prejeli v povprečju 10 krogov zdravljenja v celoti.
English: The injection procedure should be carried out under aseptic conditions.
Slovenian: Injiciranje morate izvajati v aseptičnih pogojih.
English: Key outcome measures from BRAVO and CRUISE are summarised in Table 8 and Figures 5 and 6.
Slovenian: Glavna merila izidov v študijah BRAVO in CRUISE so prikazana v preglednici 8 in na slikah 5 in 6.
English: As the embryofoetal development investigations were performed in healthy pregnant animals and disease (such as diabetes) may modify the permeability of the placenta towards a Fab fragment, the study should be interpreted with caution.
Slovenian: Ker so raziskave razvoja zarodka oziroma plodu izvajali na zdravih brejih živalih, bolezen (kot je sladkorna bolezen) pa lahko spremeni permeabilnost posteljice za Fab fragment, je pri interpretaciji rezultatov te študije potrebna previdnost.
English: Thereafter, monitoring and treatment intervals should be determined by the physician and should be based on disease activity, as assessed by visual acuity and/or anatomical parameters.
Slovenian: Od te točke dalje naj pogostnost spremljanja in intervale zdravljenja določi zdravnik glede na aktivnost bolezni na osnovi ocene ostrine vida in/ali anatomskih parametrov.
English: Treatment of visual impairment due to DME
Slovenian: Zdravljenje okvare vida zaradi DME
English: Other medicines and Lucentis
Slovenian: Druga zdravila in zdravilo Lucentis