FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment initiation at the time of diagnosis should be considered.
Danish: Det bør overvejes at opstarte behandling ved tidspunktet for diagnosen.
English: If a patient died or switched study treatment before or at week 24, then the patient was considered as having active ROP and unfavourable structural outcomes at week 24.
Danish: Hvis en patient døde eller skiftede studiebehandling før eller ved uge 24 blev patienten anset som havende aktiv ROP og ugunstige strukturelle udfald ved uge 24.
English: p<0.0001for both studies
Danish: p<0,0001 for begge studier
English: ≥50%, of the total lesion area;
Danish: ≥50 % af det totale læsionsareal;
English: 30-Jun-2023
Danish: 30-juni-2023
English: • an intraocular pressure of ≥30 mmHg;
Danish: • Et intraokulært tryk ≥30 mmHg;
English: Microscopic ocular changes were related to inflammation and did not indicate degenerative processes.
Danish: Mikroskopiske øjenforandringer blev relateret til inflammation og indikerede ikke degenerative processer.
English: There are no data available on fertility.
Danish: Der er ingen tilgængelige data vedrørende fertilitet.
English: (maintenance of vision, primary endpoint)
Danish: (Synsbevarelse, primært endepunkt)
English: Overall, ranibizumab treatment was well tolerated.
Danish: Generelt var ranibizumab-behandlingen veltolereret.
English: Please also refer to section 3 “How Lucentis is given”.
Danish: Se også afsnit 3 ”Sådan gives Lucentis”.
English: The warnings and precautions for adults also apply to preterm infants with ROP.
Danish: Advarsler og forsigtighedsregler for voksne er også gældende for præmature spædbørn med ROP.
English: Eligible patients had one of the following retinal findings in each eye:
Danish: De egnede patienter havde et af de følgende retinale fund i hvert øje:
English: 62.9% of Group II patients did not require injections in the second 6 months of the study.
Danish: 62,9 % af patienterne i gruppe II havde ikke behov for injektion i den sidste 6-måneders periode af studiet.
English: In addition, patients should be monitored during the week following the injection to permit early treatment if an infection occurs.
Danish: Desuden skal patienterne monitoreres i ugen efter injektionen for at muliggøre tidlig behandling, hvis der skulle forekomme en infektion.
English: Make sure that the pack contains:
Danish: Kontrollér, at pakningen indeholder:
English: The severity of the inflammatory response generally diminished with subsequent injections or during recovery.
Danish: Sværhedsgraden af det inflammatoriske respons mindskedes generelt ved efterfølgende injektioner eller under restitution.
English: Odds ratio is calculated by using Cochran-Mantel-Haenszel test with ROP zone at baseline (zone I and II; per CRF) as stratum factor.
Danish: Odds ratio er beregnet ved hjælp af Cochran-Mantel-Haenszel test med ROP zone ved baseline (zone I and II; per CRF) som stratum faktor.
English: Patient numbers [n] (treatment +sham)
Danish: Antal patienter [n] (behandling+sham)
English: Reduction in CSFT
Danish: Reduktion i CSFT
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.
Danish: Det binder sig med høj affinitet til isoformer af VEGF-A (f.eks. VEGF110, VEGF121 og VEGF165), hvorved det forhindrer binding af VEGF-A til dets receptorer VEGFR-1 og VEGFR-2.
English: Key outcome measures are summarised in Table 5 (RESTORE and Extension) and Figure 4 (RESTORE).
Danish: De vigtigste resultater er sammenfattet i Tabel 5 (RESTORE og Extension) og Figur 4 (RESTORE).
English: There is limited experience in patients older than 75 years with DME.
Danish: Der er begrænset erfaring med DME-patienter ældre end 75 år.
English: This information will be taken into account to evaluate if Lucentis is the appropriate treatment for you.
Danish: Denne information vil blive medtaget i vurderingen af, om Lucentis er en passende behandling til dig.
English: • the syringe is not damaged.
Danish: • Sprøjten ikke er beskadiget.
English: Treatment success
Danish: Behandlingssuccess
English: The administration of more than three injections per eye has not been studied.
Danish: Administration af mere end tre injektioner per øje er ikke blevet undersøgt.
English: Treatment of PDR
Danish: Behandling af PDR
English: Following intravitreal administration, no signs of systemic toxicity were detected.
Danish: Efter intravitreal indgivelse blev der ikke påvist tegn på systemisk toksicitet.
English: All components are sterile.
Danish: Alle komponenter er sterile.
English: With both TE regimens, more than 70% of patients maintained their BCVA with an average visit frequency of ≥2 months.
Danish: Med begge TE-regimer bevarede mere end 70 % af patienterne deres BCVA med en gennemsnitlig besøgsfrekvens på ≥2 måneder.
English: This is something you may not notice, therefore your doctor may monitor this after each injection.
Danish: Det er noget, som du nok ikke bemærker, hvorfor din læge muligvis vil kontrollere dette efter hver indsprøjtning.
English: • Key signs and symptoms of serious adverse events including increased intraocular pressure,
Danish: • Vigtige tegn og symptomer på alvorlige bivirkninger inklusive forhøjet intraokulært tryk,
English: If this happens, do not drive or use machines until this resolves.
Danish: Hvis det sker, må du ikke køre bil eller betjene maskiner, før det er forsvundet.
English: The long-term safety profile in preterm infants has not been established.
Danish: Langtidssikkerhedsprofilen for præmature spædbørn er ikke klarlagt.
English: Concomitant use of other anti-VEGF (vascular endothelial growth factor)
Danish: Samtidig brug af andre anti-VEGF (vaskulær endotelial vækstfaktor)
English: Difference in proportion (%), CI
Danish: Forskel i forhold (%), CI
English: The patient information pack should be provided in both the form of patient information booklets and an audio-CD that contain following key elements:
Danish: Patientinformationspakken skal præsenteres både i form af patientinformationsfoldere og en CD-rom indeholdende følgende nøgleelementer:
English: Limited data on bilateral use of Lucentis (including same-day administration) do not suggest an increased risk of systemic adverse events compared with unilateral treatment.
Danish: Begrænsede data om bilateral anvendelse af Lucentis (inklusive administration samme dag) tyder ikke på en øget risiko for systemiske bivirkninger sammenlignet med unilateral behandling.
English: A total of 1,323 patients (879 active and 444 control) were enrolled in these studies.
Danish: I alt 1.323 patienter (879 aktiv og 444 kontrol) blev indrulleret i disse studier.
English: The treatment is started with one injection of Lucentis per month.
Danish: Behandlingen indledes med én Lucentis-injektion hver måned.
English: - In some patients the eye pressure may increase for a short period directly after the injection.
Danish: - Hos nogle patienter kan trykket i øjet stige i en kort periode lige efter indsprøjtningen.
English: Lucentis can be used for people of 65 years of age and over without dose adjustment.
Danish: Lucentis kan anvendes til personer på 65 år og derover uden dosisjustering.
English: Your baby's doctor may monitor this after each injection.
Danish: Dit barns læge vil muligvis kontrollere dette efter hver indsprøjtning.
English: Patients with active severe intraocular inflammation.
Danish: Patienter med aktiv svær intraokulær inflammation.
English: However, there was no consistent pattern among the different haemorrhages.
Danish: Der var imidlertid ikke noget fast mønster blandt de forskellige former for blødning.
English: Detailed instructions for use are given at the end of the leaflet under “How to prepare and administer Lucentis”.
Danish: Detaljerede instruktioner for brugen er angivet sidst i denne indlægsseddel under ”Tilberedning og administration af Lucentis”.
English: Women of childbearing potential/contraception in females
Danish: Kvinder i den fertile alder/kontraception til kvinder
English: For the primary endpoint the pre-specified significance level for the one-sided p-value was 0.025.
Danish: Det præspecificerede signifikansniveau for den ensidede p-værdi for det primære endepunkt var 0,025.
English: This lack of information should be considered by the physician when treating such patients.
Danish: Lægen bør tage denne manglende dokumentation i betragtning, ved behandling hos disse patienter.
English: Number of injections up to Month 12:
Danish: Antal injektioner indtil måned 12: Gennemsnit
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.
Danish: Graviditet og amning - Kvinder, der kan blive gravide skal bruge effektiv prævention under behandling, og i mindst 3 måneder efter sidste injektion af Lucentis.
English: Please see section 4 (“Possible side effects”) for more detailed information on side effects that could occur during Lucentis therapy.
Danish: Se punkt 4 (“Bivirkninger”) for at få mere detaljeret information om de bivirkninger, som kan opstå under behandling med Lucentis.
English: These side effects may also occur in babies born prematurely.
Danish: Disse bivirkninger kan også forekomme hos for tidligt fødte småbørn.
English: b from baseline to Month 2
Danish: b fra baseline til måned 2
English: Categorised change from baseline
Danish: Kategoriseret ændring fra baseline
English: It is unknown whether Lucentis is excreted in human milk.
Danish: Det er ukendt, om Lucentis udskilles i human mælk.
English: Post-authorisation efficacy study (PAES): CRFB002H2301E1
Danish: Virkningsundersøgelse efter tilladelse til markedsføring (PAES): CRFB002H2301E1
English: - There is no experience of using Lucentis in pregnant women.
Danish: - Der foreligger ingen erfaring med brug af Lucentis til gravide kvinder.
English: • sham injection at baseline, followed by an individualised treatment regimen driven by disease activity.
Danish: • sham-injektion ved baseline, efterfulgt af et individualiseret doseringsregime bestemt af sygdomsaktivitet.
English: DRSS = diabetic retinopathy severity score, n = number of patients who satisfied the condition at the visit, N = total number of study eyes.
Danish: DRSS = diabetisk retinopati sværhedsgrads-score, n = antallet af patienter, som opfyldte tilstanden ved besøget, N = total antal forsøgsøjne.
English: Lucentis should not be administered concurrently with other anti-VEGF medicinal products (systemic or ocular).
Danish: Lucentis bør ikke administreres samtidig med andre anti-VEGF lægemidler (systemisk eller okulært).
English: Patients with active or suspected ocular or periocular infections.
Danish: Patienter med aktive eller mistænkte okulære eller periokulære infektioner.
English: Note: The plunger rod is not attached to the rubber stopper - this is to prevent air being drawn into the syringe.
Danish: Bemærk: Enden af stemplet er ikke fastgjort til gummistopperen - dette er for at forhindre, at luft trækkes ind i sprøjten.
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).
Danish: Studier på cynomolgusaber indikerer hverken direkte eller indirekte skadelige virkninger hvad angår graviditet eller embryonal/føtal udvikling (se pkt.
English: Lucentis specifically recognises and binds to a protein called human vascular endothelial growth factor A (VEGF-A) present in the eye.
Danish: Lucentis genkender specifikt og bindes til et protein, der kaldes human vaskulær endotel vækstfaktor A (VEGF-A), som findes i øjet.
English: A total of 868 patients (708 active and 160 control) were enrolled in these studies.
Danish: I alt deltog 868 patienter (708 aktive og 160 kontroller) i disse studier.
English: The treatment is started with one injection of Lucentis in each eye (some babies may only need treatment in one eye).
Danish: Behandlingen indledes med én Lucentis-injektion i hvert øje (nogle børn vil muligvis kun have behov for behandling i et øje).
English: A PK/PD analysis showed no clear relationship between systemic ranibizumab concentrations and systemic VEGF concentrations.
Danish: En PK/PDanalyse viste ingen klar sammenhæng mellem systemiske ranibizumab koncentrationer og systemiske VEGF koncentrationer.
English: It is important to identify and treat such an infection or retinal detachment as soon as possible.
Danish: Det er vigtigt at identificere og behandle sådan en infektion eller nethindeløsning så hurtigt som muligt.
English: The treatment interval should be extended by no more than two weeks at a time for wet AMD and may be extended by up to one month at a time for DME.
Danish: Behandlingsintervallerne bør højst øges med to uger ad gangen ved våd AMD og kan øges med op til en måned ad gangen ved DME.
English: b p<0.0001for null hypothesis in CRYSTAL that the mean change at Month 24 from baseline is zero.
Danish: b p<0,0001 for null-hypotesen i CRYSTAL at den gennemsnitlige ændring ved måned 24 fra baseline er nul.
English: Month
Danish: Måned
English: Cataract formation was observed in some animals after a relatively long period of intense inflammation, suggesting that the lens changes were secondary to severe inflammation.
Danish: Kataraktdannelse sås hos nogle dyr efter en relativt lang periode med intens inflammation, hvilket tyder på, at linseforandringerne var sekundære til svær inflammation.
English: Patients who experience these signs must not drive or use machines until these temporary visual disturbances subside.
Danish: Patienter, som får disse symptomer, må ikke føre bil eller betjene maskiner, før disse midlertidige synsforstyrrelser aftager.
English: These medical devices are not included within the Lucentis pack.
Danish: Dette medicinske udstyr er ikke inkluderet i Lucentis-pakningen.
English: • a subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is
Danish: • En subretinal blødning der omfatter centret af fovea, eller hvis størrelsen af blødningen er
English: Introduction Read all the instructions carefully before using the pre-filled syringe.
Danish: Introduktion Læs alle instruktioner omhyggeligt inden anvendelse af den fyldte injektionssprøjte.
English: Table 7 DRSS improvement or worsening of ≥2 or ≥3 steps at year 1 in Protocol S (LOCF Method)
Danish: Tabel 7 DRSS forbedring eller forværring på ≥2 eller ≥3 trin ved 1 år i Protocol S (LOCF metode)
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.
Danish: Derefter skal monitorerings- og behandlingsintervaller afgøres af lægen på basis af sygdomsaktivitet vurderet ved synsskarphed og/eller anatomiske parametre.
English: Treatment of ROP in preterm infants
Danish: Behandling af ROP hos præmature spædbørn
English: Gain of ≥15 letters or
Danish: Forbedring på ≥15 bogstaver eller
English: Cases of accidental overdose have been reported from the clinical studies in wet AMD and postmarketing data.
Danish: Tilfælde af overdosis givet ved uheld er blevet indberettet fra de kliniske studier i våd AMD og fra post-marketing data.
English: Sustained IOP increases have also been identified (see section 4.8).
Danish: Vedvarende forhøjet IOP er også set (se pkt.
English: Please tell your doctor immediately if you develop any of these side effects.
Danish: Fortæl det med det samme til din læge, hvis du oplever nogen af disse bivirkninger.
English: From Month 14 of the study, sham-treated patients were allowed to receive ranibizumab and from Month 19, more frequent treatments were possible.
Danish: Fra studiets måned 14 fik de sham-behandlede patienter tilladelse til at få ranibizumab-behandling, og fra måned 19 var hyppigere behandlinger muligt.
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.
Danish: Ved PDR og RVO kan behandlingsintervallerne ligeledes øges gradvis, der er dog ikke tilstrækkelige data til at konkludere på længden af disse intervaller.
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).
Danish: CI = konfidensinterval, M = samlet antal patienter uden manglende resultater for det primære effektmål (inklusive tilskrevne værdier), n = antallet af patienter med fravær af aktiv ROP og fravær af ugunstige strukturelle udfald i begge øjne 24 uger efter første studiebehandling (inklusive tilskrevne værdier).
English: In all groups, ranibizumab was administered monthly until BCVA was stable for at least three consecutive monthly assessments.
Danish: I alle grupperne blev ranibizumab administreret månedligt, indtil BCVA var stabil ved mindst tre på hinanden følgende månedlige vurderinger.
English: When given on the same day, Lucentis should be administered at least 30 minutes after laser photocoagulation.
Danish: Når det gives samme dag, bør Lucentis administreres mindst 30 minutter efter laserbehandlingen.
English: Intravitreal injection-related reactions
Danish: Intravitreale injektions-relaterede reaktioner
English: Results from both trials indicated that continued ranibizumab treatment may also be of benefit in patients who lost ≥15 letters of best-corrected visual acuity (BCVA) in the first year of treatment.
Danish: Resultater fra begge studier viste, at kontinuerlig ranibizumab-behandling også kan være en fordel hos de patienter, som har mistet ≥15 bogstaver af bedst korrigeret synsskarphed (BCVA) i det første år af behandlingen.
English: In DME studies, the improvement in BCVA was accompanied by a reduction over time in mean CSFT in all the treatment groups.
Danish: I DME-studier var forbedringen i BCVA ledsaget af et fald over tid i gennemsnitlig CSFT i alle behandlingsgrupper.
English: Patients treated with Lucentis in PIER received a mean of 10 total treatments.
Danish: Patienter behandlet med Lucentis i PIER fik i gennemsnit 10 hele behandlinger.
English: Table 4 Treatment effect overall and across baseline aetiology subgroups
Danish: Tabel 4 Behandlingseffekt generelt og på tværs af ætiologiske undergrupper ved baseline
English: Table 10 Outcomes at Week 24 (RAINBOW)
Danish: Tabel 10 Resultater ved uge 24 (RAINBOW)
English: a p<0.0001for both comparisons in BRIGHTER at Month 6: Lucentis 0.5 mg vs Laser and Lucentis 0.5 mg + Laser vs Laser.
Danish: a p<0,0001 for begge sammenligninger i BRIGHTER ved måned 6: Lucentis 0,5 mg vs laser og Lucentis 0,5 mg + laser vs laser.
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.
Danish: Da de embryonale/føtale udviklingsundersøgelser blev udført på raske drægtige dyr, og da sygdom (såsom diabetes) kan påvirke permeabiliteten af placenta over for et Fab-fragment, skal studiet fortolkes med forsigtighed.
English: -0.4 letters
Danish: -0,4 bogstaver
English: Proper aseptic injection techniques must always be used when administering Lucentis.
Danish: Der skal altid anvendes korrekt aseptisk injektionsteknik ved indgivelse af Lucentis.
English: Additionally, change in diabetic retinopathy (DR) severity was assessed based on fundus photographs using the DR severity score (DRSS).
Danish: Yderligere blev ændringen i alvorligheden af diabetisk retinopati (DR) vurderet ud fra fundusfotografering ved brug af DR score for alvorlighedsgrad (DRSS).
English: Treatment effect over sham [letters]
Danish: Behandlingseffekt bedre end sham [bogstaver]
English: The number of scheduled treatment visits after the initial 3 injections, was 13 and 20 for the TE and PRN regimens, respectively.
Danish: Antallet af planlagte behandlingsbesøg efter de første 3 injektioner var 13 og 20 for henholdsvis TEog p.n.-regime.
English: There is limited experience of treatment with Lucentis in diabetic patients with an HbA1c over 108 mmol/mol (12%) and no experience in patients with uncontrolled hypertension.
Danish: Der er begrænset erfaring med Lucentis-behandling hos diabetiske patienter med HbA1c over 108 mmol/mol (12 %) og ingen erfaring hos patienter med ukontrolleret hypertension.
English: Pharmacotherapeutic group: Ophthalmologicals, antineovascularisation agents, ATC code: S01LA04
Danish: Farmakoterapeutisk klassifikation: Oftalmologika, antineovaskulære midler, ATC-kode: S01LA04
English: In all groups, monthly treatment was re-initiated upon a decrease in BCVA due to DME progression and continued until stable BCVA was reached again.
Danish: I alle grupperne blev månedlig behandling gen-initieret ved fald i BCVA som følge af DME-progression og fortsat, indtil stabil BCVA igen blev opnået.
English: Patients should be instructed to report any symptoms suggestive of endophthalmitis or any of the above mentioned events without delay.
Danish: Patienterne skal instrueres i ufortøvet at indberette alle symptomer, der tyder på endoftalmit eller en eller flere af ovennævnte hændelser.
English: After Lucentis treatment you may experience some temporary vision blurring.
Danish: Efter behandling med Lucentis kan du opleve en vis midlertidig sløring af synet.
English: What Lucentis is used for Lucentis is used in adults to treat several eye diseases causing vision impairment.
Danish: Hvad Lucentis bruges til Lucentis bruges hos voksne til at behandle flere forskellige øjensygdomme, der giver synsnedsættelse.
English: The treatment of visual impairment due to CNV should be determined individually per patient based on disease activity.
Danish: Behandling af synsnedsættelse grundet CNV bør fastlægges individuelt baseret på den enkelte patients sygdomsaktivitet.
English: By binding to VEGF-A, Lucentis can block its actions and prevent this abnormal growth and swelling.
Danish: Ved at bindes til VEGF-A kan Lucentis blokere dets funktion og forhindre denne unormale vækst og opsvulmen.
English: Women of childbearing potential should use effective contraception during treatment.
Danish: Kvinder i den fertile alder bør anvende sikker kontraception under behandlingen.
English: On TE, ranibizumab was administered at treatment intervals of 2-3 months.
Danish: Ved TE-regime blev ranibizumab administreret med intervaller på 2-3 måneder.
English: There is only limited experience in the treatment of subjects with DME due to type I diabetes.
Danish: Der er kun begrænset erfaring med behandlingen af patienter med DME, som skyldes type I-diabetes.
English: • When to seek urgent attention from the health care provider
Danish: • Hvornår man omgående skal henvende sig til den behandlende læge
English: The opening of the sealed tray and all subsequent steps should be done under aseptic conditions.
Danish: Åbning af den forseglede bakke og alle efterfølgende trin skal udføres under aseptiske betingelser.
English: The syringe is ready for injection.
Danish: Sprøjten er nu klar til injektion.
English: If an overdose occurs, intraocular pressure should be monitored and treated, if deemed necessary by the attending physician.
Danish: Hvis en overdosis forekommer, skal det intraokulære tryk monitoreres og behandles, i fald den behandlende læge skønner det nødvendigt.
English: The primary endpoint was the mean visual acuity change at year 2.
Danish: Det primære endepunkt var den gennemsnitlige ændring i synsskarphed ved år 2.
English: The effect of ranibizumab treatment was similar irrespective of the presence of retinal ischaemia.
Danish: Effekten af behandlingen med ranibizumab var tilsvarende, uanset tilstædeværelse af retinal iskæmi.
English: The doctor will also give your baby a local anaesthetic to reduce or prevent any pain.
Danish: Lægen vil også give dit barn lokalbedøvelse for at mindske eller forhindre smerte.