FrancophonIA/ELRC3.0 huggingface dataset:
English: Serum ranibizumab concentrations are predicted to be approximately 90,000-fold lower than vitreal ranibizumab concentrations.
Danish: Serumranibizumab koncentrationer forudsiges at være ca. 90.000 gange lavere end corpus vitreumranibizumab koncentrationer.
English: In patients with <3 months disease duration an increase in visual acuity of 13.3 and 10.0 letters was seen at Month 1; and 17.7 and 13.2 letters at Month 24 in BRIGHTER and CRYSTAL, respectively.
Danish: For patienter med en sygdomsvarighed < 3 måneder blev der set en stigning i synsskarphed på 13,3 og 10,0 bogstaver ved måned 1 samt 17,7 og 13,2 bogstaver ved måned 24 i henholdsvis BRIGHTER og CRYSTAL.
English: • What are the steps following treatment with Lucentis
Danish: • Hvad sker der efter behandlingen med Lucentis
English: In this study 178 adult patients were randomised in a 2:1 ratio to receive:
Danish: I dette studie blev 178 voksne patienter randomiseret i forholdet 2:1 til at få:
English: The mean number of injections given over 12 months was 5.8 in the ranibizumab arm versus 5.4 in those patients in the sham arm who were eligible to receive ranibizumab from Month 2 onwards.
Danish: Det gennemsnitlige antal injektioner givet over 12 måneder var 5,8 i ranibizumab-armen versus 5,4 hos de patienter i sham-armen, som var egnede til at få ranibizumab fra måned 2 og frem.
English: In RVO patients, 48.2% (253 of 525) had renal impairment (36.4% mild, 9.5% moderate and 2.3% severe).
Danish: Hos patienter med RVO havde 48,2 % (253 af 525) nyreinsufficiens (36,4 % let, 9,5 % moderat og 2,3 % svær).
English: - Inform your doctor if you have a prior history of eye conditions or eye treatments, or if you have had a stroke or experienced transient signs of stroke (weakness or paralysis of limbs or face, difficulty speaking or understanding).
Danish: - Fortæl det til din læge, hvis du har haft tidligere tilfælde af øjensygdomme eller øjenbehandlinger, eller hvis du har haft et slagtilfælde eller oplevet forbigående tegn på slagtilfælde (svaghed eller lammelse af arme, ben eller ansigt, besvær med at tale eller opfatte).
English: Lucentis is indicated in preterm infants for:
Danish: Lucentis er indiceret hos præmature spædbørn til:
English: - Lucentis is not recommended during breast-feeding because it is not known whether Lucentis passes into human milk.
Danish: - Lucentis anbefales ikke under amning, da det ikke vides, om Lucentis går over i modermælken.
English: Hold the syringe at eye level and carefully push the plunger until the edge below the dome of the rubber stopper is aligned with the dose mark (see Figure 7).
Danish: Hold sprøjten i niveau med øjnene og tryk forsigtigt stemplet ind, indtil kanten under gummistopperens runding er på linje med doseringsmærket (se figur 7).
English: Nevertheless, a case was described with high maternal ranibizumab serum levels and presence of ranibizumab in foetal serum, suggesting that the anti-ranibizumab antibody acted as (Fc region containing) carrier protein for ranibizumab, thereby decreasing its maternal serum clearance and enabling its placental transfer.
Danish: Der er dog beskrevet et tilfælde med høje maternelle serumværdier af ranibizumab og tilstedeværelse af ranibizumab i føtalt serum, indikerende at anti-ranibizumab-antistof virkede som (Fc-region indeholdende) proteinbærer for ranibizumab, hvorved den maternelle serum-clearence blev sænket, og overførsel over placenta blev muliggjort.
English: • Zone I, stage 1+, 2+, 3 or 3+ disease, or
Danish: • Sygdom i Zone I, stadie 1+, 2+, 3 eller 3+, eller
English: Unfavourable structural outcomes were less frequently reported for ranibizumab 0.2 mg (1 patient, 1.4%) compared with laser therapy (7 patients, 10.1%).
Danish: Ugunstige strukturelle udfald blev mindre hyppigt rapporteret for ranibizumab 0,2 mg (1 patient, 1,4 %) sammenlignet med laserbehandling (7 patienter, 10,1 %).
English: Your baby's doctor will advise you and decide how long your baby should be treated with Lucentis.
Danish: Dit barns læge vil rådgive dig og beslutte, hvor længe dit barn bør behandles med Lucentis.
English: During the 24 weeks of the study, fewer patients in the ranibizumab 0.2 mg group switched to another treatment modality due to lack of response compared with the laser group (14.9% vs. 24.3%).
Danish: Undervejs i forsøgets 24 uger skiftede færre patienter i ranibizumab 0,2 mg gruppen til en anden behandlingsmodalitet på grund af manglende respons sammenlignet med laserbehandlingsgruppen (14,9 % vs. 24,3 %).
English: Limited data from sham subjects who later received ranibizumab suggested that early initiation of treatment may be associated with better preservation of visual acuity.
Danish: Begrænsede data fra patienter, der fik sham, og som senere fik ranibizumab, viste, at tidlig opstart af behandling kan være forbundet med bedre synsbevarelse.
English: Lucentis should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Lucentis skal inspiceres visuelt for partikler og misfarvning før administration.
English: The filter needle should be discarded after withdrawal of the vial contents and should not be used for the intravitreal injection.
Danish: Filterkanylen skal kasseres efter optrækning af hætteglasindholdet og må ikke anvendes til den intravitreale injektion.
English: The injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required).
Danish: Injektionsproceduren skal udføres under aseptiske forhold, hvilket omfatter brug af kirurgisk hånddesinfektion, sterile handsker, et sterilt afdækningsstykke og et sterilt øjenlågsspekel (eller tilsvarende) og mulighed for steril paracentese (hvis påkrævet).
English: In total, up to three injections per eye may be administered within six months of treatment initiation if there are signs of disease activity.
Danish: I alt kan der gives op til tre injektioner per øje indenfor seks måneder efter behandlingsstart, hvis der er tegn på sygdomsaktivitet.
English: Intraocularly, there were dose-dependent increases in anterior chamber flare and cells with a peak 2 days after injection.
Danish: Intraokulært var der dosisafhængig forøgelse af lysvej og celler i forreste kammer, med maksimum 2 dage efter injektion.
English: If any of the above is not true, discard the pre-filled syringe and use a new one.
Danish: Hvis noget af ovenstående er tilfældet, skal den fyldte injektionssprøjte bortskaffes og en ny anvendes i stedet.
English: The patient's medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure.
Danish: Patientens anamnese mht. overfølsomhedsreaktioner skal vurderes omhyggeligt før udførelse af den intravitreale procedure.
English: One-sided p<0.001 comparison with sham control b
Danish: En-sidet p<0,001 sammenligning med sham-kontrol b
English: Note: Do not wipe the needle at any time.
Danish: Bemærk: Kanylen må på intet tidspunkt aftørres.
English: 6.1 List of excipients α,α-trehalose dihydrate Histidine hydrochloride, monohydrate Histidine
Danish: 6.1 Hjælpestoffer α,α-trehalosedihydrat Histidinhydrochloridmonohydrat Histidin
English: The difference in least square means was 3.5 letters (95% CI: [0.2 to 6.7]).
Danish: Forskellen i mindste kvadraters gennemsnit var 3,5 bogstaver (95 % CI [0,2 til 6,7]).
English: There is a potential for immunogenicity with Lucentis.
Danish: Der er risiko for immunogenicitet ved brug af Lucentis.
English: Gain of ≥15 letters in visual acuity at Month 12 (%) Proportion (%) receiving laser rescue over 12 months
Danish: Forbedring i synsskarphed på ≥15 bogstaver ved måned 12 (%) Andel (%) der fik laser rescue i løbet af 12 måneder
English: Table 8 Outcomes at Month 6 and 12 (BRAVO and CRUISE)
Danish: Tabel 8 Resultater ved måned 6 og 12 (BRAVO og CRUISE)
English: When initiating ranibizumab therapy, caution should be used in patients with these risk factors for retinal pigment epithelial tears.
Danish: Ved opstart af ranibizumab-behandling bør der udvises forsigtighed hos patienter med disse risikofaktorer for rifter i pigmentepitelcellelaget i retina.
English: Also, while a consistent effect was observed in subjects with subfoveal and juxtafoveal lesions, there are insufficient data to conclude on the effect of Lucentis in PM subjects with extrafoveal lesions.
Danish: Derudover er der, på trods af, at der er set en konsistent effekt hos patienter med subfoveale og jukstafoveale læsioner, utilstrækkelige data til at konkludere på Lucentis effekt hos patienter med PM, der har ekstrafoveale læsioner.
English: The doctor will monitor the condition of your baby's eye(s) and, depending on how your baby responds to the treatment, will decide if and when further treatment is needed.
Danish: Lægen vil kontrollere dit barns øje/øjne, og afhængigt af, hvordan dit barn reagerer på behandlingen, vil lægen beslutte, om og hvornår efterfølgende behandling er nødvendig.
English: Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A (VEGF-A).
Danish: Ranibizumab er et humaniseret rekombinant monoklonalt antistoffragment rettet mod human vaskulær endotelial vækstfaktor A (VEGF-A).
English: For CNV secondary to pathologic myopia (PM), many patients may only need one or two injections during the first year.
Danish: Ved CNV som følge af patologisk myopi (PM) vil mange patienter måske kun have behov for en eller to injektioner det første år.
English: However, subjects with a baseline BCVA >73 letters and macular oedema with central retinal thickness <300 µm did not appear to benefit from treatment with ranibizumab compared to laser photocoagulation.
Danish: Dog syntes forsøgspersoner med baseline-BCVA >73 bogstaver og maculaødem med central retinatykkelse <300 µm ikke at have gavn af behandling med ranibizumab sammenlignet med laserbehandling.
English: Read all of this leaflet carefully before your baby is given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden dit barn begynder at få dette lægemiddel, da den indeholder vigtige oplysninger.
English: Patients randomised to vPDT were allowed to receive ranibizumab treatment as of Month 3 (in Group III, 38 patients received ranibizumab as of Month 3)
Danish: Det var tilladt, at patienter randomiseret til vPDT fik ranibizumab fra og med måned 3 (i gruppe III fik 38 patienter ranibizumab fra og med måned 3).
English: A total of 88 eyes (22.3%) had baseline DME: 42 (22.0%) and 46 (22.7%) eyes in the ranibizumab and PRP groups, respectively.
Danish: Et total på 88 øjne (22,3 %) havde DME ved baseline: 42 (22,0 %) og 46 (22,7 %) øjne i henholdsvis ranibizumab og PRP-gruppen.
English: All injections will be administered by your eye doctor.
Danish: Alle indsprøjtninger vil blive givet af din øjenlæge.
English: What Lucentis is
Danish: Hvad Lucentis er
English: Based on analysis of population pharmacokinetics and disappearance of ranibizumab from serum for patients with neovascular AMD treated with the 0.5 mg dose, the average vitreous elimination half-life of ranibizumab is approximately 9 days.
Danish: På basis af analyse af populationsfarmakokinetik og ranibizumabs forsvinden fra serum for patienter med neovaskulær AMD behandlet med dosen på 0,5 mg er den gennemsnitlige corpus vitreumeliminationshalveringstid for ranibizumab ca. 9 dage.
English: A low incidence rate of arterial thromboembolic events was observed in the Lucentis clinical trials in patients with AMD, DME, PDR, RVO and CNV and there were no major differences between the groups treated with ranibizumab compared to control.
Danish: Der blev observeret en lav forekomst af arterielle tromboemboliske tilfælde i de kliniske studier med Lucentis hos patienter med AMD, DME, PDR, RVO og CNV og der var ingen større forskel mellem de grupper, der blev behandlet med ranibizumab, og kontrolgrupperne.
English: • ranibizumab 0.5 mg at baseline, followed by an individualised dosing regimen driven by disease activity as assessed by visual acuity and/or anatomical parameters (e.g. VA impairment, intra/sub-retinal fluid, haemorrhage or leakage);
Danish: • ranibizumab 0,5 mg ved baseline, efterfulgt af et individualiseret doseringsregime bestemt af sygdomsaktivitet vurderet ved synsskarphed og/eller anatomiske parametre (fx nedsat synsskarphed, intra/subretinal væske, blødning og lækage);
English: In this study, the mean visual acuity change at year 2 was +2.7 letters in the ranibizumab group compared to -0.7 letters in the PRP group.
Danish: I dette studie var den gennemsnitlige ændring i synsskarphed ved år 2 +2,7 bogstaver i ranibizumabgruppen sammenlignet med -0,7 bogstaver i PRP-gruppen.
English: All components are sterile and for single use only.
Danish: Alle komponenter er sterile og udelukkende til engangsbrug.
English: • the solution looks clear, colourless to pale yellow and does not contain any particles.
Danish: • Injektionsvæsken er klar, farveløs til svagt gul og ikke indeholder partikler.
English: In a population pharmacokinetic analysis of neovascular AMD patients, 68% (136 of 200) of patients had renal impairment (46.5% mild [50-80 ml/min], 20% moderate [30-50 ml/min], and 1.5% severe [<30 ml/min]).
Danish: I en farmakokinetisk populationsanalyse af patienter med neovaskulær AMD havde 68 procent (136 ud af 200) af patienterne nyreinsufficiens (46,5 % let [50-80 ml/min], 20 % moderat [30-50 ml/min] og 1,5 % svær [<30 ml/min]).
English: Attach a 30G x ½″ sterile injection needle firmly onto the syringe by screwing it tightly onto the Luer lock (see Figure 4).
Danish: Sæt en 30G x ½″ steril injektionskanyle fast på sprøjten ved at skrue den godt fast på Luer-lock-adapteren (se figur 4).
English: All injections will be administered by the eye doctor.
Danish: Alle indsprøjtninger vil blive givet af øjenlægen.
English: intraocular inflammation, retinal detachment & retinal tear and infectious endophthalmitis
Danish: intraokulær inflammation, nethindeløsning & nethinderift og infektiøs endophthalmitis
English: What Lucentis is used for
Danish: Hvad Lucentis bruges til
English: Table 1 Outcomes at Month 12 and Month 24 in study FVF2598g (MARINA) and FVF2587g (ANCHOR)
Danish: Tabel 1 Resultater efter måned 12 og måned 24 i studie FVF2598g (MARINA) og FVF2587g (ANCHOR)
English: In Group II, which is the recommended posology (see section 4.2), 50.9% of patients required 1 or 2 injections, 34.5% required 3 to 5 injections and 14.7% required 6 to 12 injections over the 12-month study period.
Danish: 4.2), havde 50,9 % af patienterne behov for 1 eller 2 injektioner, 34,5 % havde behov for 3 til 5 injektioner, og 14,7 % havde behov for 6 til 12 injektioner i studieperioden på 12 måneder.
English: The majority of adverse reactions reported following administration of Lucentis are related to the intravitreal injection procedure.
Danish: Størstedelen af bivirkninger, som er rapporteret efter behandling med Lucentis, er relateret til den intravitreale injektionsprocedure.
English: • How to prepare for Lucentis treatment
Danish: • Forberedelse til Lucentis-behandling
English: In the 405 DRSS gradable patients with moderate NPDR or better, a ≥2-step DRSS improvement was observed in 1.4% and 0.9% of the ranibizumab and laser groups, respectively.
Danish: For de 405 DRSS-graduerede patienter med moderat NPDR eller bedre, blev der observeret en ≥2-trins DRSS forbedring hos 1,4 % og 0,9 % i henholdsvis ranibizumab- og lasergruppen.
English: The clinical safety and efficacy of Lucentis in patients with PDR have been assessed in Protocol S which evaluated the treatment with ranibizumab 0.5 mg intravitreal injections compared with panretinal photocoagulation (PRP).
Danish: Den kliniske sikkerhed og virkning af Lucentis til patienter med PDR er blevet undersøgt i Protokol S, som evaluerede behandling med ranibizumab 0,5 mg intravitreale injektioner sammenlignet med panretinal fotokoagulation (PRP).
English: • the syringe cap is not detached from the Luer lock.
Danish: • Sprøjte-hætten ikke er adskilt fra Luerlock-adapteren.
English: Uncommon serious side effects (may affect up to 1 in 100 people): Blindness, infection of the eyeball (endophthalmitis) with inflammation of the inside of the eye.
Danish: Ikke almindelige bivirkninger, der er alvorlige (kan forekomme hos op til 1 ud af 100 personer): Blindhed, infektion i øjenæblet (endoftalmit) med inflammation indeni øjet.
English: The filter needle is not for injection.
Danish: Filterkanylen må ikke anvendes til injektion.
English: You must not receive Lucentis - If you are allergic to ranibizumab or any of the other ingredients of this medicine (listed in section 6).
Danish: Du bør ikke få Lucentis - Hvis du er allergisk over for ranizumab eller et af de øvrige indholdsstoffer i Lucentis (angivet i punkt 6).
English: Renal impairment Dose adjustment is not needed in patients with renal impairment (see section 5.2).
Danish: Nyreinsufficiens Der er ikke behov for dosisjustering hos patienter med nyreinsufficiens (se pkt.
English: Injecting the entire volume of the pre-filled syringe could result in overdose.
Danish: Hvis hele det udtagelige volumen injiceres, kan det medføre overdosering.
English: In clinical studies for the treatment of visual impairment due to DME, the outcome with regard to visual acuity or central retinal subfield thickness (CSFT) in patients treated with Lucentis was not affected by concomitant treatment with thiazolidinediones.
Danish: I kliniske studier vedrørende behandling af nedsat syn grundet DME var resultatet med hensyn til synsskarphed eller central retinadelfelttykkelse (CSFT) hos patienter, der blev behandlet med Lucentis, ikke påvirket af samtidig behandling med thiazolidindioner.
English: Cmax was dose proportional over the dose range of 0.05 to 1.0 mg/eye.
Danish: Cmax var dosisproportional gennem dosisintervallet på 0,05-1,0 mg/øje.
English: Key outcome measures from BRIGHTER and CRYSTAL are shown in Table 9.
Danish: Hovedresultaterne fra BRIGHTER og CRYSTAL er vist i tabel 9.
English: The key outcome measures are summarised in Table 6.
Danish: De vigtigste resultatmål er opsummeret i Tabel 6.
English: Hold the syringe upright.
Danish: Hold sprøjten lodret.
English: For CNV secondary to pathologic myopia (PM), many patients may only need one or two injections during the first year (see section 5.1).
Danish: Ved CNV som følge af patologisk myopi (PM) vil mange patienter måske kun have behov for en eller to injektioner det første år (se pkt.
English: In the wet AMD phase III studies, the overall frequency of non-ocular haemorrhages, an adverse event potentially related to systemic VEGF (vascular endothelial growth factor) inhibition, was slightly increased in ranibizumab-treated patients.
Danish: I våd AMD fase III-studierne var den samlede frekvens af ikke-okulære blødninger, en bivirkning som potentielt er relateret til VEGF (vaskulær endotelial vækstfaktor)-hæmning, let øget hos ranibizumabbehandlede patienter.
English: Preterm infants
Danish: Præmature spædbørn
English: • The treatment of neovascular (wet) age-related macular degeneration (AMD)
Danish: • Behandling af neovaskulær (våd) aldersrelateret maculadegeneration (AMD)
English: The study compared ranibizumab 0.5 mg intravitreal injections to standard treatment with PRP.
Danish: Studiet sammenlignede ranibizumab 0,5 mg intravitreale injektioner med standardbehandling med PRP.
English: For the intravitreal injection, a 30G x ½″ sterile injection needle should be used.
Danish: Til den intravitreale injektion skal en 30G x ½″ steril injektionskanyle anvendes.
English: • Zone II, stage 3+ disease, or
Danish: • Sygdom i Zone II, stadie 3+, eller
English: There is a theoretical risk of arterial thromboembolic events, including stroke and myocardial infarction, following intravitreal use of VEGF inhibitors.
Danish: Der er en teoretisk risiko for arterielle tromboemboliske hændelser inklusive apopleksi og myokardieinfarkt ved intravitreal anvendelse af VEGF-hæmmere.
English: Please find information for babies born prematurely on the other side of this leaflet.
Danish: Se venligst information til for tidligt fødte småbørn på bagsiden af denne indlægsseddel.
English: In both studies, subjects received either 0.3 mg or 0.5 mg ranibizumab or sham injections.
Danish: I begge studier fik patienterne enten 0,3 mg eller 0,5 mg ranibizumab eller shaminjektion.
English: In preterm infants treatment of ROP is initiated with a single injection per eye and may be given bilaterally on the same day.
Danish: Behandlingen af ROP hos præmature spædbørn initieres med en enkelt injektion per øje, og kan gives i begge øjne den samme dag.
English: How Lucentis works
Danish: Hvordan Lucentis virker
English: Withholding Lucentis in adults
Danish: Tilbageholdelse af Lucentis hos voksne
English: Group II Ranibizumab 0.5 mg “disease activity” (n=116)
Danish: Gruppe II ranibizumab 0,5 mg “sygdomsaktivitet” (n=116)
English: Overall and per baseline aetiology
Danish: Generelt og i henhold til ætiologi ved baseline
English: Key outcome measures from MINERVA are summarised in Table 3 and Figure 3.
Danish: Hovedresultaterne fra MINERVA er opsummeret i Tabel 3 og Figur 3.
English: There are insufficient data to conclude on the effect of Lucentis in patients with RVO presenting irreversible ischaemic visual function loss.
Danish: Der er utilstrækkelige data til at kunne konkludere på effekten af Lucentis hos patienter med RVO, som har irreversibelt, iskæmisk synstab.
English: a p<0.00001 comparison with vPDT control b
Danish: Ikke relevant a p<0,00001 sammenlignet med vPDT-kontrol b
English: Serum ranibizumab concentrations in RVO patients were similar or slightly higher compared to those observed in neovascular AMD patients.
Danish: Serumkoncentrationer af ranibizumab hos RVO-patienter var tilsvarende eller lidt højere end koncentrationer, observeret hos patienter med neovaskulær AMD.
English: The effect in terms of visual improvement was observed in all patients treated with 0.5 mg ranibizumab monotherapy regardless of their disease duration in both BRIGHTER and CRYSTAL.
Danish: Effekten, i form af forbedring af synet, blev observeret hos alle patienter, der fik behandling med 0,5 mg ranibizumab monoterapi i både BRIGHTER og CRYSTAL, uanset deres sygdomsvarighed.
English: Also contains: α,α-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections.
Danish: Indeholder også: α, α-trehalosedihydrat; histidinhydrochlorid, monohydrat; histidin; polysorbat 20; vand til injektionsvæsker.
English: The patient's medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see section 4.4).
Danish: Patientens anamnese mht. overfølsomhedsreaktioner skal vurderes omhyggeligt før udførelse af den intravitreale procedure (se pkt.
English: Treatment of wet AMD
Danish: Behandling af våd AMD
English: Key outcome measures are summarised in Table 1 and Figure 1.
Danish: De vigtigste resultater er sammenfattet i Tabel 1 og Figur 1.
English: Single dose for babies born prematurely: 0.2 mg/0.02 ml.
Danish: Enkeltdosis til for tidligt fødte småbørn: 0,2 mg/0,02 ml.
English: It may also be associated with choroidal neovascularisation (CNV) due to pathologic myopia (PM), angioid streaks, central serous chorioretinopathy or inflammatory CNV.
Danish: Det kan også være forbundet med koroidal neovaskularisation (CNV) som følge af patologisk myopi (PM), karlignende striber, central serøs korioretinopati eller inflammatorisk (betændelseslignende) CNV.
English: Intraocular pressure increases
Danish: Forhøjet intraokulært tryk
English: In wet AMD, in CNV, in PDR and in visual impairment due to DME or to macular oedema secondary to RVO the recommended dose for Lucentis is 0.5 mg given as a single intravitreal injection.
Danish: Ved våd AMD, ved CNV, ved PDR og ved synsnedsættelse grundet DME eller maculaødem som følge af RVO er den anbefalede dosis Lucentis 0,5 mg givet som en enkelt intravitreal injektion.