FrancophonIA/ELRC3.0 huggingface dataset:
English: Eylea was shown to be as effective as ranibizumab in maintaining vision in patients with wet AMD: looking at the results of the two studies together, the proportions of patients who maintained vision were 96.1% (517 out of 538), 95.4% (533 out of 559) and 95.3% (510 out of 535) for 0.5 mg Eylea every four weeks, 2 mg Eylea every four weeks and 2 mg Eylea every eight weeks, respectively, compared with 94.4% (508 out of 538) of patients treated with ranibizumab every four weeks.
Danish: I begge studier tilsammen var andelen af patienter, der bevarede synsevnen, henholdsvis 96,1 % (517 ud af 538), 95,4 % (533 ud af 559) og 95,3 % (510 ud af 535) for 0,5 mg Eylea hver fjerde uge, 2 mg Eylea hver fjerde uge og 2 mg Eylea hver ottende uge.
English: • the ‘wet' form of age-related macular degeneration (AMD), a disease which affects the central part of the retina (called the macula) at the back of the eye.
Danish: • den "våde" form for aldersbetinget makulær degeneration (AMD), der er en sygdom, som angriber den gule plet (nethindens centrale del, der kaldes makula) i den bageste del af øjet.
English: The wet form of AMD is caused by choroidal neovascularisation (the abnormal growth of blood vessels under the macula), which may leak fluid and blood and cause swelling;
Danish: Den våde form for AMD skyldes koroidal neovaskularisering (unormal dannelse af blodkar under den gule plet), som kan afgive væske og blod og medføre hævelse
English: For the full list of side effects of Eylea, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Eylea fremgår af indlægssedlen.
English: The European Medicines Agency noted that for wet AMD Eylea was as effective as ranibizumab in maintaining patients' vision after the first year of treatment.
Danish: Det Europæiske Lægemiddelagentur konstaterede, at Eylea var lige så effektivt som ranibizumab til at opretholde synsevnen efter det første års behandling hos patienter med den våde form for AMD.
English: The benefit was largely maintained with as-needed treatment up to 52 weeks, although some of the benefit seemed to be lost when patients were treated and followed up for longer periods than this.
Danish: Virkningen varede i høj grad ved i behandlinger, hvor der blev givet injektioner efter behov i op til 52 uger, selvom noget af fordelen lod til at gå tabt, når patienterne blev behandlet og opfulgt i mere end 52 uger.
English: The pre-filled syringe contains more than the recommended dose, therefore when preparing the injection, the doctor must expel the excess volume from the syringe and ensure the injection of the correct dose.
Danish: Når injektionsvæsken gøres klar, skal lægen derfor trykke den overskydende mængde ud af sprøjten og sørge for at injicere den korrekte dosis.
English: Eylea was also investigated in two other main studies involving 366 patients with macular oedema following CRVO.
Danish: Eylea blev desuden undersøgt i to andre hovedstudier af 366 patienter med makulært ødem som følge af CRVO.
English: In addition the Agency considered that Eylea was beneficial in improving vision of patients with macular oedema resulting from CRVO, BRVO or diabetes as well as patients with myopic choroidal neovascularisation.
Danish: Desuden konkluderede agenturet, at Eylea var effektivt til at forbedre synsevnen hos patienter med makulært ødem som følge af CRVO, BRVO eller diabetes samt hos patienter med koroidal neovaskularisering forårsaget af myopi.
English: Two further main studies involving 872 patients with diabetic macular oedema looked at the effect of Eylea compared with laser treatment.
Danish: I to yderligere hovedstudier, der omfattede 872 patienter med makulært ødem forårsaget af diabetes, blev der set nærmere på virkningen af Eylea sammenlignet med laserbehandling.
English: The main measure of effectiveness was the change in the number of letters that could be read in an eye test after 24 weeks of treatment.
Danish: Det primære mål for virkningen var ændringen i antallet af bogstaver, som kunne læses i en synsprøve efter 24 ugers behandling.
English: In addition, the company will carry out a study investigating extended treatment intervals with Eylea in diabetic macular oedema, as well as a study looking at the effects of Eylea treatment when given on an as-needed basis in wet AMD.
Danish: Derudover skal virksomheden gennemføre et studie, der ser nærmere på øgede intervaller i behandlingen med Eylea hos patienter med makulært ødem, som skyldes diabetes, og et studie, der ser nærmere på virkningen af behandlingen, når Eylea gives efter behov hos patienter med den våde form for AMD.
English: VEGF-A and PlGF are involved in stimulating the abnormal growth of blood vessels in patients with AMD, certain types of macular oedema and myopic choroidal neovascularisation.
Danish: VEGF-A og PlGF medvirker begge til stimulationen af den unormale karvækst hos patienter med AMD, visse typer af makulært ødem og koroidal neovaskularisering forårsaget af myopi.
English: Another main study involving 181 patients with macular oedema due to BRVO compared monthly injections of Eylea 2 mg with laser treatment.
Danish: I et andet hovedstudie, der omfattede 181 patienter med makulært ødem forårsaget af BRVO, blev månedlige injektioner af Eylea på 2 mg sammenlignet med laserbehandling.
English: These compared monthly injections of Eylea 2 mg with a sham injection using a syringe without a needle.
Danish: I denne forbindelse blev månedlige injektioner af Eylea på 2 mg sammenlignet med en skininjektion, hvor der blev anvendt en sprøjte uden kanyle.
English: Eylea also produced a significant improvement in vision in patients with macular oedema following CRVO and BRVO.
Danish: Eylea medførte også en væsentlig forbedring af synsevnen hos patienter med makulært ødem som følge af CRMV og BRVO.
English: Serious injection-related side effects (which have occurred in less than 1 in around 2,000 injections) include blindness, endophthalmitis (serious infection or inflammation inside the eye), cataracts, increased intraocular pressure, vitreous haemorrhage (bleeding into the jelly-like fluid in the eye, causing temporary loss of vision) and vitreous or retinal detachment.
Danish: Alvorlige injektionsrelaterede bivirkninger (som optræder efter mindre end 1 ud af ca. 2 200 injektioner) omfatter blindhed, endoftalmitis (alvorlig infektion eller inflammation i øjet), grå stær, forhøjet tryk i øjet, blødning i glaslegemet (blødning ind i den geléagtige væske i øjet, hvilket forårsager midlertidigt tab af synsevnen) og løsning af glaslegemet eller nethinden.
English: The pre-filled syringe and the vial are for single use only.
Danish: Den fyldte sprøjte og hætteglasset er kun til engangsbrug.
English: • impaired vision due to macular oedema (swelling) that follows blockage of either the main vein carrying blood from the retina (known as central retinal vein occlusion, CRVO) or of smaller branch veins (known as branch retinal vein occlusion, BRVO);
Danish: • nedsat synsevne som følge af makulært ødem (hævelse) efter blokering af enten hovedvenen, der fører blodet væk fra nethinden (dette kaldes retinal centralveneokklusion (CRVO)), eller af mindre grenvener (dette kaldes retinal grenveneokklusion (BRVO))
English: The studies in patients with macular oedema following CRVO also looked at the effects of treatment on an as-needed basis after 24 weeks.
Danish: Studierne af patienter med makulært ødem forårsaget af CRVO så også nærmere på virkningen efter 24 uger af behandling efter behov.
English: In all the studies, the main measure of effectiveness was the proportion of patients who responded and whose vision improved by 15 or more letters on an eye test after 24 weeks of treatment.
Danish: I alle studierne var det primære mål for virkningen andelen af patienter, der responderede og havde opnået en forbedring af synsevnen med mindst 15 bogstaver ved en synsprøve efter 24 ugers behandling.
English: For BRVO, around 53% of patients given Eylea had an improvement of 15 letters or more in the eye test at week 24, compared with 27% of patients who received laser treatment.
Danish: Hvad angår BRVO, var synsevnen hos cirka 53 % af de patienter, som fik Eylea, forbedret med 15 bogstaver eller mere ved en synsprøve i den 24. uge, sammenholdt med 27 % hos de patienter, der fik laserbehandling.
English: Myopic choroidal neovascularisation
Danish: Koroidal neovaskularisering forårsaget af myopi
English: How is Eylea used?
Danish: Hvordan anvendes Eylea?
English: The most common side effects (affecting at least 1 in 20 patients) reported with Eylea are conjunctival haemorrhage (bleeding from the small blood vessels on the surface of the eye at the site of injection), reduced vision, eye pain, vitreous detachment (detachment of the jelly-like substance inside the eye), cataract (clouding of the lens), vitreous floaters (small particles or spots in the vision) and increased intraocular pressure (increased pressure inside the eye).
Danish: De hyppigste bivirkninger ved Eylea (som optræder hos mindst 1 ud af 20 patienter) er konjunktival blødning (blødning fra de små blodkar på øjets overflade på injektionsstedet), nedsat synsevne, smerter i øjnene, løsning af glaslegemet, grå stær (uklarhed af linsen), flydere i glaslegemet og forhøjet intraokulært tryk (forhøjet tryk i øjet).
English: Eylea must not be used in patients who have or are thought to have ocular or periocular infections (infections in or around the eyes), or in patients who have severe inflammation inside the eye. For the full list of restrictions,see the package leaflet.
Danish: Eylea må ikke anvendes hos patienter, der har eller menes at have infektioner i eller omkring øjnene eller alvorlig inflammation i øjet.
English: What benefits of Eylea have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Eylea?
English: The main measure of effectiveness in both studies was the change in the number of letters that could be read in an eye test after one year of treatment.
Danish: I begge studier var det primære mål for virkningen ændringen i antallet af bogstaver, som patienten kunne læse i en synsprøve efter ét års behandling.
English: How does Eylea work?
Danish: Hvordan virker Eylea?
English: Eylea is available as prefilled syringes or vials containing a solution for intravitreal injection (injection into the vitreous humour, the jelly-like fluid inside the eye).
Danish: Eylea fås som fyldt sprøjte eller hætteglas med en opløsning til intravitreal injektion (injektion i glaslegemet, den geléagtige væske inden i øjet).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eylea have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Eylea.
English: Macular oedema following retinal vein occlusion
Danish: Makulært ødem som følge af retinalveneokklusion
English: For CRVO, overall about 60% of patients given Eylea had an improvement of 15 letters or more in the eye test at week 24, compared with 17% of those given sham injections.
Danish: Eylea, samlet set forbedret med 15 bogstaver eller mere ved en synsprøve i den 24. uge, sammenlignet med 17 % hos de patienter, der fik skininjektioner.
English: Diabetic macular oedema
Danish: Diabetisk makulært ødem
English: In myopic choroidal neovascularisation, Eylea was investigated in a main study involving 122 patients, which compared Eylea with a sham injection.
Danish: I et hovedstudie af 122 patienter med koroidal neovaskularisering forårsaget af myopi blev Eylea sammenlignet med en skininjektion.
English: In the study in myopic choroidal neovascularisation, the average number of letters patients could read in an eye test before treatment was about 56; patients given Eylea could read on average 12 more letters after 24 weeks of treatment whereas in patients given sham injections the total number of letters they could read decreased on average by 2.
Danish: Patienter, der fik Eylea, kunne i gennemsnit læse 12 bogstaver mere efter 24 ugers behandling, mens antallet af bogstaver, der kunne læses af patienter, der fik skininjektioner, i gennemsnit faldt med 2.
English: In patients with diabetic macular oedema, the average number of letters they could read in an eye test before treatment was about 59 to 60; in patients given Eylea monthly this improved by around 12 letters, and in those given Eylea every other month by around 11 letters.
Danish: Hos patienter med makulært ødem forårsaget af diabetes var det gennemsnitlige antal bogstaver, som de inden behandlingen kunne læse i en synsprøve, ca. 59-60.
English: Strength Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform Administration Emballage Indhold Pakningsstørrelse
English: Content Pack size
Danish: EMA's procedurenr
English: 1/1 M
Danish: 1/1 L
English: For all bisphosphonates
Danish: For alle bisfosfonater
English: Annex IV Conditions of the marketing authorisation
Danish: Bilag IV Betingelser for markedsføringstilladelsen
English: The communication should be based on the “key communication messages document” agreed by CHMP and annexed to the assessment report.
Danish: Kommunikationen skal være baseret på det "nøgleinformationsdokument", som CHMP har vedtaget, og som er vedlagt evalueringsrapporten.
English: National Competent Authorities, coordinated by the Reference Member State as applicable, should ensure the following:
Danish: De nationale kompetente myndigheder, evt. koordineret af referencemedlemsstaten, skal sikre følgende:
English: The MAHs should submit/update the Risk Management Plans to reflect "atypical femoral fractures" as potential risk.
Danish: Indehaverne skal sende/opdatere risikostyringsplanerne, så de afspejler "atypiske femurfrakturer" som potentiel risiko.
English: National Competent Authorities should ensure that Health Care Professionals will be informed of the measures agreed by CHMP to minimise the risk of atypical femoral fractures.
Danish: De nationale kompetente myndigheder skal sikre, at sundhedspersonale informeres om de foranstaltninger, der er blevet vedtaget af CHMP for at minimere risikoen for atypiske femurfrakturer.
English: The MAHs within 2 months of the Commission Decision should liaise with the National Competent Authorities to agree on the timelines for submission of the Risk Management Plans.
Danish: Indehaverne af markedsføringstilladelserne skal, senest 2 måneder efter Kommissionens afgørelse, samarbejde med de nationale kompetente myndigheder for at aftale tidsfristerne for indsendelse af risikostyringsplaner.
English: Content (concentration)
Danish: Emballage Indhold (koncentration)
English: 7 multi-dose vials
Danish: 7 hætteglas til multi-dosis
English: 1 ml
Danish: Hætteglas (glas) 1 ml
English: MA (EU) number (Invented) name
Danish: Nummer i EFregistret
English: Immediate Packaging
Danish: Okulær brug
English: EU (MA) Number
Danish: EU (MF) Nummer
English: Cutaneous use tube (alu)
Danish: Tube (alu)
English: What you need to know before you take <active substance>:
Danish: Hvad du skal vide, før du begynder at tage <aktivt indholdsstof>:
English: By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Ved at rapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen vil eventuelt efterfølgende blive opdateret af myndighederne i medlemslandet, i samarbejde med referencemedlemslandet og i overensstemmelse med procedurerne i kapitel 4, afsnit III i Direktiv 2001/83/EC, hvis det er relevant.
English: These amendments to the relevant sections of the Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure.
Danish: Ændringerne til de relevante afsnit i produktresuméet, etiketteringen og indlægssedlen er resultatet af referralproceduren.
English: Rare: hypersensitivity reactions
Danish: Sjælden: overfølsomhedsreaktioner
English: Healthcare professionals are asked to report any suspected adverse reactions via [the national reporting system listed in Appendix V*].
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via [det nationale indberetningssystem anført i Appendiks V*].
English: If symptoms or signs of a progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, <active substance> treatment should be discontinued immediately and medical advice should be sought.
Danish: Hvis der er symptomer eller tegn på progressiv hududslæt (sommetider med blærer eller slimhindelæsioner), skal behandlingen med <aktivt indholdsstof> stoppes med det samme, og der skal søges lægelig rådgivning.
English: Rash, urticaria
Danish: Udslæt, urticaria
English: [The following sub-heading should appear at the end of this section] Reporting of side effects
Danish: [Følgende undertitel skal forekomme i slutningen af dette afsnit] Indberetning af formodede bivirkninger
English: 4.4 Warning and precautions
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: If you develop a skin rash (including lesions of the mucous membranes such as mouth, throat, nose, eyes, genitals), stop using <invented name> and contact your doctor immediately.
Danish: Hvis du udvikler hududslæt (herunder forandringer i slimhinderne i f.eks. munden, halsen, næsen, øjnene eller på kønsorganerne), skal du stoppe med at tage <særnavn> og omgående kontakte din læge.
English: A. Summary of Product Characteristics [For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Danish: A. Produktresumé [For alle produkter anført i Bilag I skal den eksisterende produktinformation ændres (tilføjelse, erstatning eller sletning af tekst afhængigt af, hvad der er relevant) med henblik på at afspejle nedenstående ordlyd]
English: B. Package Leaflet [For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Danish: B. Indlægsseddel [For alle produkter anført i Bilag I skal den eksisterende produktinformation ændres (tilføjelse, erstatning eller sletning af tekst afhængigt af, hvad der er relevant) med henblik på at afspejle nedenstående ordlyd]
English: Rare: rash, urticaria
Danish: Sjælden: udslæt, urticaria
English: You can also report side effects directly via [the national reporting system listed in Appendix V*].
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via [det nationale indberetningssystem anført i Appendiks V*].
English: Not known: anaphylactic reactions including anaphylactic shock, angioedema and pruritus Skin and subcutaneous tissue disorders
Danish: Ikke kendt: anafylaktiske reaktioner, herunder anafylaktisk shock, angioødem og pruritus Hud og subkutane væv
English: Not known: frequency cannot be estimated from the available data Anaphylactic reactions including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous, mucosa or submucosal tissues) and pruritus Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis).
Danish: Ikke kendt: Hyppigheden kan ikke bestemmes ud fra de tilgængelige data Anafylaktiske reaktioner, herunder anafylaktisk shock, angioødem (allergisk reaktion med hurtig udvikling af hævelse i ansigt, læber, mund, tunge og/eller hals) og kløe Alvorlige bivirkninger i huden (herunder erythema multiforme, Stevens-Johnsons syndrom/toksisk epidermal nekrolyse og akut generaliseret eksematøs pustulose).
English: Not known: Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis).
Danish: Ikke kendt: Alvorlige kutane reaktioner (herunder erythema multiforme, Stevens-Johnsons syndrom/toksisk epidermal nekrolyse og akut generaliseret eksantematøs pustulose).
English: There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP) associated with the administration of <active substance>.
Danish: I forbindelse med indtagelse af <aktiv stof> er der set tilfælde af alvorlige hudlæsioner, såsom erythema multiforme, Stevens-Johnsons syndrom (SJS)/toksisk epidermal nekrolyse (TEN) og akut generaliseret eksantematøs pustulose (AGEP).
English: [The below paragraph should be reflected in this section for all ambroxol- and bromhexine-containing medicinal products]
Danish: [For alle ambroxol- og bromhexinholdige lægemidler skal nedenstående paragraf afspejles i dette afsnit]
English: [The following warning should be reflected in this section for all ambroxol- and bromhexine-containing medicinal products]
Danish: [For alle ambroxol- og bromhexinholdige lægemidler skal følgende advarsel afspejles i dette afsnit] Der er set alvorlige hudreaktioner, der kan være forårsaget af <aktivt indholdsstof>.
English: Rare: may affect up to 1 in 1,000 people:
Danish: [For ambroxol- og bromhexinholdige lægemidler skal de anførte bivirkninger angives i dette afsnit] Sjælden: Forekommer hos op til 1 ud af 1000 personer:
English: Possible side effects
Danish: Indberetning af bivirkninger
English: • Your doctor will decide how many treatments you need.
Danish: • Din læge bestemmer, hvor mange behandlinger, du har brug for.
English: • It is very important that you do not miss a dose of this medicine.
Danish: • Det er meget vigtigt, at du ikke går glip af en dosis af denne medicin.
English: Date of first authorisation: 21 September 2018
Danish: Dato for første markedsføringstilladelse: 21. september 2018
English: It is used when your NSCLC:
Danish: Det bruges, når NSCLC:
English: Your doctor may give you other medicines that prevent more severe complications and to help reduce your symptoms.
Danish: Din læge vil måske give dig andre lægemidler, som forhindrer mere alvorlige komplikationer og for at hjælpe med at mindske dine symptomer.
English: The analysis of OS was performed approximately 13 months after the primary analysis of PFS.
Danish: Analysen af OS blev udført ca. 13 måneder efter den primære analyse af PFS.
English: The storage details are as follows:
Danish: Opbevaringsbetingelserne er som følger:
English: • you have an autoimmune disease (an illness where the body's immune system attacks its own cells);
Danish: • du har en autoimmun sygdom (en sygdom, hvor kroppens immunsystem angriber sine egne celler)
English: Grade 2 for > 1 week
Danish: Grad 2 i >1 uge
English: NR: Not Reached
Danish: NR: Ikke opnået.
English: See Table 3 and Figures 1 and 2.
Danish: Se tabel 3 og figur 1 og 2.
English: All Patients
Danish: Alle patienter
English: Steady state was achieved at approximately 16 weeks.
Danish: Steady-state blev opnået ved ca. 16. uge.
English: In the absence of data, durvalumab should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis.
Danish: I mangel på data bør durvalumab anvendes med forsigtighed til disse populationer efter nøje overvejelse af den potentielle fordel/risiko på individuel basis.
English: • you have liver problems.
Danish: • du har leverproblemer.
English: The presence of ADAs did not have a clinically relevant effect on safety.
Danish: Tilstedeværelsen af ADA'er havde ingen klinisk relevant effekt på sikkerheden.
English: However, a potential risk to the breast-fed child cannot be excluded.
Danish: En potentiel risiko for det ammede barn kan dog ikke udelukkes.
English: PD-L1 Unknown
Danish: PD-L1 ukendt