FrancophonIA/ELRC3.0 huggingface dataset:
English: Before the injection, your baby's doctor will wash your baby's eyes carefully to prevent infection.
Danish: Før injektionen vil dit barns læge vaske dit barns øjne omhyggeligt for at undgå infektion.
English: Please find information for adults on the other side of this leaflet.
Danish: Se venligst information til voksne på bagsiden af denne indlægsseddel.
English: 240 patients, who had previously completed the 12-month RESTORE study, were enrolled in the open-label, multicentre 24-month extension (RESTORE Extension) study.
Danish: 240 patienter, der tidligere havde gennemført det 12 måneder lange RESTORE-studie, blev indskrevet i det 24 måneder lange, åbne multicenterforlængelsesstudie (RESTORE Extension).
English: If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see Figure 6).
Danish: Hvis der er luftbobler, slås let på sprøjten med en finger, indtil boblerne søger mod toppen (se figur 6).
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.
Danish: I det bageste segment var der vitreal celleinfiltration og mouches volantes, som også havde tendens til at være dosisafhængige, og de varede generelt ved til udgangen af behandlingsperioden.
English: If you are pregnant, think you may be pregnant or planning to become pregnant, discuss this with your doctor before treatment with Lucentis.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds før behandling med Lucentis.
English: 90429 Nuremberg
Danish: 90429 Nürnberg
English: The injection procedure should be carried out under aseptic conditions.
Danish: Injektionen skal udføres under aseptiske betingelser.
English: Each prefilled syringe should only be used for the treatment of a single eye.
Danish: Hver fyldte injektionssprøjte må kun anvendes til behandling af ét øje.
English: 95% CI Comparison Odds ratio (OR)
Danish: Behandling n/M (%) 95% CI Sammenligning Odds ratio (OR)
English: Adverse reactions established for adult indications are considered applicable to preterm infants with ROP, though not all were observed in the RAINBOW trial.
Danish: Bivirkninger klarlagt for de voksne indikationer er anset som værende gældende for præmature spædbørn på trods af, at de ikke alle blev observeret i RAINBOW-forsøget.
English: The efficacy and safety of Lucentis have been assessed in three randomised, controlled studies of at least 12 months duration.
Danish: Lucentis' effekt og sikkerhed blev vurderet i tre randomiserede, kontrollerede studier af mindst 12 måneders varighed.
English: In both studies, a rapid and statistically significant decrease from baseline in central retinal subfield thickness was observed at Month 1.
Danish: I begge studier blev der opbserveret et hurtig og statistisk signifikant fald fra baseline i central retinadelfelttykkelse ved måned 1.
English: In the 26-week study, the severity of the vitreous inflammation increased with the number of injections.
Danish: I studiet på 26 uger steg sværhedsgraden af corpus vitreuminflammationen med antallet af injektioner.
English: (stage 3+) or AP-ROP (aggressive posterior ROP) disease.
Danish: zone II (stadie 3+) eller AP-ROP (aggressiv posterior ROP)
English: Mean number of injections (months 0-23) p<0.0001 for assessment of non-inferiority to PRN
Danish: Gennemsnitligt antal injektioner (måned 0-23) p<0,0001 for vurdering af non-inferioritet i forhold til p.n.
English: Before withdrawal, the outer part of the rubber stopper of the vial should be disinfected.
Danish: Før optrækning skal den udvendige del af hætteglassets gummiprop desinficeres.
English: The treatment procedure may induce temporary visual disturbances, which may affect the ability to drive or use machines (see section 4.8).
Danish: Behandlingsproceduren kan fremkalde midlertidige synsforstyrrelser, som kan påvirke evnen til at føre bil eller betjene maskiner (se pkt.
English: Your doctor will monitor the condition of your eye and, depending on how you respond to the treatment, will decide if and when you need to receive further treatment.
Danish: Din læge vil kontrollere dit øje, og afhængigt af, hvordan du reagerer på behandlingen, vil lægen beslutte, om og hvornår du skal have efterfølgende behandling.
English: The absence of ranibizumab-mediated effects on embryo-foetal development is plausibly related mainly to the inability of the Fab fragment to cross the placenta.
Danish: Fravær af ranibizumab-virkninger på embryonal-/føtaludvikling er sandsynligvis hovedsagligt relateret til Fab-fragmentets manglende evne til at passere placenta.
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.
Danish: Kvinder, der ønsker at blive gravide, og som er blevet behandlet med ranibizumab, anbefales at vente i mindst 3 måneder efter den sidste behandling, før barnet undfanges.
English: Other side effects which may occur following Lucentis treatment are described below: Common side effects
Danish: Andre bivirkninger som kan forekomme efter behandling med Lucentis er beskrevet herunder: Almindelige bivirkninger
English: Serum concentrations in a limited number of DME patients indicate that a slightly higher systemic exposure cannot be excluded compared to those observed in neovascular AMD patients.
Danish: Serumkoncentrationer hos et begrænset antal DME-patienter viser, at en lidt højere systemisk eksponering ikke kan udelukkes sammenlignet med dem, der blev observeret hos patienter med neovaskulær AMD.
English: Serum and vitreous antibodies to ranibizumab were found in a subset of treated animals.
Danish: Serum- og corpus vitreum-antistoffer mod ranibizumab blev fundet i en delmængde af de behandlede dyr.
English: If disease activity recurs, the treatment interval should be shortened accordingly.
Danish: Hvis der igen opstår tegn på sygdomsaktivitet, skal behandlingsintervallerne forkortes tilsvarende.
English: In the phase IIIb study D2304 (RETAIN), 372 patients were randomised in 1:1:1 ratio to receive:
Danish: I fase IIIb-studiet D2304 (RETAIN) blev 372 patienter randomiseret i forholdet 1:1:1 til at få:
English: Your doctor will advise you and decide how long you should be treated with Lucentis.
Danish: Din læge vil rådgive dig og beslutte, hvor længe du bør behandles med Lucentis.
English: The interval between two doses injected into the same eye should be at least four weeks.
Danish: Intervallet mellem to doser, der gives i samme øje, bør være mindst fire uger.
English: Intravitreal use.
Danish: Intravitreal anvendelse.
English: This is observed in diseases such as age-related macular degeneration (AMD) and proliferative diabetic retinopathy (PDR, a disease caused by diabetes).
Danish: Dette ses ved sygdomme såsom alders-relateret maculadegeneration (AMD) og proliferativ diabetisk retinopati (PDR, en sygdom som forårsages af diabetes).
English: The nature and timing of the posterior segment inflammation is suggestive of an immune-mediated antibody response, which may be clinically irrelevant.
Danish: Arten og tidspunktet for inflammationen i det bageste segment tyder på et immunmedieret antistofrespons, som måske er klinisk irrelevant.
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).
Danish: Bivirkningerne er opført efter organsystemklasse og hyppighed: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Lucentis has not been studied in patients who have previously received intravitreal injections, in patients with active systemic infections, or in patients with concurrent eye conditions such as retinal detachment or macular hole.
Danish: Lucentis er ikke blevet undersøgt hos patienter, der tidligere har fået intravitreale injektioner, hos patienter med aktive systemiske infektioner eller hos patienter med samtidig øjensygdom såsom nethindeløsning eller makulært hul.
English: Bilateral intravitreal administration of ranibizumab to cynomolgus monkeys at doses between 0.25 mg/eye and 2.0 mg/eye once every 2 weeks for up to 26 weeks resulted in dose-dependent ocular effects.
Danish: Bilateral intravitreal indgivelse af ranibizumab til cynomolgusaber i doser på mellem 0,25 mg/øje og 2,0 mg/øje en gang hver 2. uge i op til 26 uger resulterede i dosisafhængige øjenvirkninger.
English: Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle.
Danish: Sørg for at stemplet trækkes tilstrækkeligt tilbage, når hætteglasset tømmes for at være sikker på at filterkanylen tømmes helt.
English: The majority of patients treated with ranibizumab 0.2 mg (78.1%) received a single injection per eye.
Danish: Størstedelen af patienterne behandlet med ranibizumab 0,2 mg (78,1 %) modtog en enkelt injektion per øje.
English: Ask your doctor or pharmacist for advice before Lucentis treatment.
Danish: Spørg din læge eller apoteket til råds, før behandling med Lucentis.
English: Table 3 Outcomes at Month 2 (MINERVA)
Danish: Tabel 3 Resultater ved måned 2 (MINERVA)
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.
Danish: Protokol S var et randomiseret, aktivt kontrolleret, non-inferioritets fase III-multicenterstudie med parallelle grupper, hvor 305 patienter (349 forsøgsøjne) med PDR med eller uden DME ved baseline blev inkluderet.
English: Patients not losing >15 letters from baseline at Month 2
Danish: Patienter, som ikke havde forringelse >15 bogstaver fra baseline ved måned 2
English: In patients with wet AMD, DME, PDR and RVO, initially, three or more consecutive, monthly injections may be needed.
Danish: Hos patienter med våd AMD, DME, PDR og RVO kan det initielt være nødvendigt at indgive tre eller flere konsekutive, månedlige injektioner.
English: Allergic reactions (rash, urticaria, pruritus, erythema)
Danish: Allergiske reaktioner (udslæt, urticaria, pruritus, eksem)
English: - Lucentis is given as an injection into the eye.
Danish: - Lucentis gives som en indsprøjtning i øjet.
English: Carefully remove the needle cap by pulling it straight off (see Figure 5).
Danish: Fjern forsigtigt kanyle-hætten ved at trække den lige af (se figur 5).
English: BL=baseline; SE=standard error of mean * Difference in least square means, p0.0001/0.0004 based on two-sided stratified Cochran-MantelHaenszel test
Danish: BL = baseline; SE= standardafvigelse på middelværdi * Forskel i mindste kvadraters middelværdi, p<0,0001/0,0004 baseret på to-sidet stratificeret CochranMantel-Haenszel test
English: Since the volume contained in the vial (0.23 ml) is greater than the recommended dose (0.05 ml for adults and 0.02 ml for preterm infants), a portion of the volume contained in the vial must be discarded prior to administration.
Danish: Da volumet indeholdt i hætteglasset (0,23 ml) er større end den anbefalede dosis (0,05 ml for voksne og 0,02 ml for præmature spædbørn), skal en del af volumet indeholdt i hætteglasset kasseres inden administration.
English: • Group I (ranibizumab 0.5 mg, dosing regimen driven by “stability” criteria defined as no change in BCVA compared to two preceding monthly evaluations).
Danish: • Gruppe I (ranibizumab 0,5 mg, doseringsregime bestemt af kriterier for ”stabilitet”, defineret som ingen ændring i BCVA ved sammenligning med de to foregående månedlige vurderinger)
English: Both intraocular pressure and the perfusion of the optic nerve head must be monitored and managed appropriately.
Danish: Både intraokulært tryk og perfusionen af synsnervepapillen skal monitoreres og behandles på behørig vis.
English: Lucentis should not be used during pregnancy unless the potential benefit outweighs the potential risk to the unborn child.
Danish: Lucentis bør ikke anvendes under graviditet med mindre de mulige fordele overvejer de eventuelle risici for det ufødte barn.
English: The mean number of ranibizumab injections given in the study eye over 12 months was 3 (ranged from 2 to 5).
Danish: Det gennemsnitlige antal injektioner af ranibizumab givet i forsøgsøjet over 12 måneder var 3 (fra 2 til 5 injektioner).
English: • a decrease in best-corrected visual acuity (BCVA) of ≥30 letters compared with the last assessment of visual acuity;
Danish: • Et fald i bedst korrigeret synsskarphed (BCVA) af ≥30 bogstaver sammenlignet med den sidste bestemmelse af synsskarphed;
English: Dispose of the used syringe together with the needle in a sharps disposal container or in accordance with local requirements.
Danish: Bortskaf den brugte sprøjte sammen med kanylen i en kanyleboks eller i henhold til lokale retningslinjer.
English: Therefore, ranibizumab should not be used during pregnancy unless the expected benefit outweighs the potential risk to the foetus.
Danish: Ranibizumab må derfor ikke anvendes under graviditet, medmindre den forventede fordel ved behandlingen opvejer den potentielle risiko for fosteret.
English: Treatment should be discontinued in subjects with rhegmatogenous retinal detachment or stage 3 or 4 macular holes.
Danish: Behandlingen bør afbrydes hos individer med rhegmatogen nethindeløsning eller maculært hul i stadium 3 eller 4.
English: Lucentis is indicated in adults for:
Danish: Lucentis er indiceret hos voksne til:
English: * Starting at Month 6 ranibizumab 0.5 mg treatment was allowed (24 patients were treated with laser only).
Danish: * Fra måned 6 og var behandling med ranibizumab 0,5 mg tilladt (24 patienter blev behandlet med laser alene).
English: A transient increase in post-dose intraocular pressure was observed following intravitreal injections, irrespective of dose.
Danish: Der sås en kortvarig stigning i det intraokulære tryk efter intravitreale injektioner, uanset dosis.
English: Treatment success, as measured by the absence of active ROP and absence of unfavourable structural outcomes in both eyes 24 weeks after the first study treatment, was highest with ranibizumab 0.2 mg (80%) compared to laser therapy (66.2%) (see Table 10).
Danish: Behandlingssuccess, målt som fravær af aktiv ROP og fravær af ugunstige strukturelle udfald i begge øjne 24 uger efter den første studiebehandling, var højest ved ranibizumab 0,2 mg (80 %) sammenlignet med laserbehandling (66,2 %) (se tabel 10).
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.
Danish: Derudover har Det Europæiske Lægemiddelagentur dispenseret fra kravet om at fremlægge resultaterne af studier af ROP med Lucentis i følgende undergrupper af den pædiatriske population: mature nyfødte, spædbørn, børn og unge.
English: The corresponding visual acuity gain in patients with ≥12 months disease duration was 8.6 and 8.4 letters in the respective studies.
Danish: Den tilsvarende forbedring i synsskarphed hos patienter med en sygdomsvarighed ≥ 12 måneder, var 8,6 og 8,4 bogstaver for de respektive studier.
English: *Ranibizumab is a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology.
Danish: *Ranibizumab er et humaniseret monoklonalt antistoffragment fremstillet i Escherichia coli-celler vha. rekombinant dna-teknologi.
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.
Danish: Da der muligvis er øget systemisk eksponering hos patienter med DME, kan en øget risiko for overfølsomhedsreaktioner hos disse patienter ikke udelukkes.
English: Key outcome measures from BRAVO and CRUISE are summarised in Table 8 and Figures 5 and 6.
Danish: De vigtigste resultater fra BRAVO og CRUISE er sammenfattet i Tabel 8 og i Figur 5 og 6.
English: The adverse reactions experienced following administration of Lucentis in clinical trials are summarised in the table below.
Danish: Bivirkninger efter administration af Lucentis i kliniske forsøg er beskrevet i tabellen nedenfor.
English: • Group III (vPDT - patients were allowed to receive ranibizumab treatment as of Month 3).
Danish: • Gruppe III (vPDT - patienterne måtte få ranibizumab-behandling fra og med måned 3).
English: If, in the physician's opinion, visual and anatomical parameters indicate that the patient is not benefiting from continued treatment, Lucentis should be discontinued.
Danish: Hvis lægen vurderer, at visuelle og anatomiske parametre indikerer, at patienten ikke får gavn af fortsat behandling, bør Lucentis seponeres.
English: Table 6 Outcomes in study D2304 (RETAIN)
Danish: Tabel 6 Resultater i studie D2304 (RETAIN)
English: Table 2 Outcomes at Month 3 and 12 (RADIANCE)
Danish: Tabel 2 Resultater ved måned 3 og 12 (RADIANCE)
English: It is important to identify and treat serious side effects such as infection of the eyeball or retinal detachment as soon as possible.
Danish: Det er vigtigt, at identificere og behandle alvorlige bivirkninger, så som infektion i øjeæblet eller løsning af nethinden, hurtigst muligt.
English: 9.5 letters
Danish: 9,5 bogstaver
English: At Month 2, all patients received open-label treatment with ranibizumab as needed.
Danish: Fra måned 2 fik alle patienter åben behandling med ranibizumab efter behov.
English: Caution should be exercised when treating such patients (see section 4.8).
Danish: Der skal udvises forsigtighed ved behandling af sådanne patienter (se pkt.
English: The pre-filled syringe has a plunger rod and a finger grip, and is packed in a sealed tray.
Danish: Den fyldte injektionssprøjte har et stempel og et fingergreb og er pakket i en forseglet bakke.
English: Prior to launch in each Member State the MAH shall agree the final educational material with the National Competent Authority.
Danish: • Yderligere risikominimeringsforanstaltninger Forud for markedsføring i hver enkelt medlemsstat skal markedsføringsindehaveren drøfte det endelige uddannelsesmateriale med den relevante nationale myndighed.
English: • The treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II
Danish: • Behandling af præmatur retinopati (ROP) med sygdommen i zone I (stadie 1+, 2+,3 eller 3+),
English: Data from two studies (MONT BLANC, BPD952A2308 and DENALI, BPD952A2309) conducted post approval confirmed the efficacy of Lucentis but did not demonstrate additional effect of the combined administration of verteporfin (Visudyne PDT) and Lucentis compared to Lucentis monotherapy.
Danish: Data fra to studier (MONT BLANC, BPD952A2308 og DENALI, BPD952A2309), udført efter godkendelse, bekræftede Lucentis' virkning, men viste ikke yderligere effekt ved kombinationsbehandling med verteporfin (Visudyne fotodynamisk terapi) og Lucentis, sammenlignet med Lucentis som monoterapi.
English: Your doctor will also give you a local anaesthetic to reduce or prevent any pain you might have with the injection.
Danish: Din læge vil også give dig lokalbedøvelse for at mindske eller forhindre smerte i forbindelse med injektionen.
English: In this study 277 patients were randomised in a 2:2:1 ratio to the following arms:
Danish: I dette studie blev 277 patienter randomiseret i forholdet 2:2:1 til følgende arme:
English: When comparing ranibizumab versus sham control at Month 2, a consistent treatment effect both overall and across baseline aetiology subgroups was observed:
Danish: Når behandling med ranibizumab sammenlignes med sham-kontrol ved måned 2, blev der observeret en ensartet behandlingseffekt både generelt og på tværs af ætiologiske undergrupper ved baseline:
English: Inject
Danish: Injektion
English: * The proportion of patients who did not require any ranibizumab treatment during the extension phase was 19%, 25% and 20% in the prior ranibizumab, prior ranibizumab + laser and prior laser groups, respectively.
Danish: * Andelen af patienter, der ikke havde behov for behandling med ranibizumab i forlængelsesfasen, var 19 %, 25 % og 20 % i de grupper, der tidligere havde fået henholdsvis ranibizumab, ranibizumab + laser og laser.
English: Outcome measure compared to baseline
Danish: Resultatmål sammenlignet med baseline
English: The MAH shall ensure that, following discussions and agreements with the National Competent Authorities in each Member State where Lucentis is marketed, at launch and after launch all ophthalmological clinics where Lucentis is expected to be used are provided with an up-to-date patient information pack.
Danish: Før og efter markedsføringen skal indehaveren af markedsføringstilladelsen, efter drøftelser og aftale med de relevante nationale myndigheder i hvert medlemsland, hvor Lucentis markedsføres, sikre, at alle oftalmologiske afdelinger og klinikker, hvor Lucentis forventes anvendt, får udleveret en opdateret informationspakke til patienterne.
English: The systemic exposure to ranibizumab is low after ocular administration, but due to its mechanism of action, ranibizumab must be regarded as potentially teratogenic and embryo-/foetotoxic.
Danish: Den systemiske eksponering for ranibizumab er meget lille efter okulær indgivelse, men på grund at dets virkningsmekanisme skal ranibizumab betragtes som potentielt teratogent og embryo-/føtotoksisk.
English: Risk factors associated with the development of a retinal pigment epithelial tear after anti-VEGF therapy for wet AMD and potentially also other forms of CNV, include a large and/or high pigment epithelial retinal detachment.
Danish: Risikofaktorer forbundet med udvikling af en rift i pigmentepitelcellelaget i retina efter anti-VEGFbehandling for våd AMD og muligvis også andre former for CNV inkluderer en stor/eller høj retinal pigmentepitelløsning.
English: - Do not use this medicine after the expiry date which is stated on the carton and pre-filled syringe label after EXP.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og etiketten efter EXP.
English: • The treatment of proliferative diabetic retinopathy (PDR)
Danish: • Behandling af proliferativ diabetisk retinopati (PDR)
English: Additional side effects that have been observed with Lucentis in adults are listed below.
Danish: Yderligere bivirkninger, som er blevet observeret med Lucentis hos voksne, er beskrevet nedenfor.
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)
Danish: Måned 12 -10,5 (16,6) +7,2 (14,4) -9,5 (16,4) +11,3 (14,6) Måned 24 -14,9 (18,7) +6,6 (16,5) -9,8 (17,6) +10,7 (16,5)
English: For information on preparation of Lucentis, see section 6.6.
Danish: For information om tilberedning af Lucentis, se pkt.
English: Before the injection, your doctor will wash your eye carefully to prevent infection.
Danish: Før injektionen vil din læge vaske dit øje forsigtigt for at undgå infektion i øjet.
English: Table 9 Outcomes at Months 6 and 24 (BRIGHTER and CRYSTAL)
Danish: Tabel 9 Resultater ved måned 6 og 24 (BRIGHTER og CRYSTAL)
English: A total of 191 eyes (48.5%) were randomised to ranibizumab 0.5 mg and 203 eyes (51.5%) eyes were randomised to PRP.
Danish: Et total på 191 øjne (48,5 %) blev randomiseret til ranibizumab 0,5 mg og 203 øjne (51,5 %) blev randomiseret til PRP.
English: In the sham arm 7 out of 59 patients did not receive any treatment with ranibizumab in the study eye during the 12-month period.
Danish: I shamarmen fik 7 ud af 59 patienter ingen behandling med ranibizumab i forsøgsøjet i 12-måneders perioden.