FrancophonIA/ELRC3.0 huggingface dataset:
English: (<1/10,000); and not known (cannot be estimated from available data).
Danish: (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Wait 30 minutes
Danish: Vent 30 minutter
English: Dispose of it (see Step 9), and start again with a new pen.
Danish: Bortskaf den (se Trin 9), og start igen med en ny pen.
English: Date of first authorisation: 02 December 2015
Danish: Dato for første markedsføringstilladelse: 02. december 2015
English: • Wait 30 minutes (and no more than 8 hours) before use.
Danish: • Vent 30 minutter (og ikke mere end 8 timer) inden brug.
English: **From spontaneous post marketing reporting.
Danish: **Fra spontane post marketing rapporter
English: Administer once every four weeks.
Danish: Indgives én gang hver fjerde uge.
English: Your injection may take up to 15 seconds to complete.
Danish: Din injektion kan tage op til 15 sekunder at fuldføre.
English: If you live in a region where these infections are common or if you are travelling to such a region:
Danish: Hvis du bor i et område, hvor disse infektioner er almindelige, eller hvis du skal rejse til et sådant område:
English: Get ready what you need
Danish: Klargør det, du skal bruge
English: Some people may have allergic or allergic-like reactions.
Danish: Nogle personer kan få allergiske eller allergilignende reaktioner.
English: The safety profile was similar to that seen in adults.
Danish: Sikkerhedsprofilen svarede til den, der blev set hos voksne.
English: Call your doctor.
Danish: Ring til lægen.
English: Small air bubbles, however, are expected and acceptable.
Danish: Det kan dog forventes, at der er små luftbobler, og disse er acceptable.
English: • You should hear the 1st “click” to tell you your injection has started.
Danish: • Du bør høre det første ”klik”, som fortæller dig, at injektionen er startet.
English: Inspect and wait 30 minutes before use
Danish: Inspicér og vent 30 minutter før brug
English: Continue to hold down as you count to 5, then lift off
Danish: Fortsæt med at holde nede, mens du tæller til 5, og løft derefter op
English: In adults, adolescents and children, this magnitude of reduction was observed within 4 weeks of treatment.
Danish: Hos voksne, unge og børn blev omfanget af reduktionen observeret inden for 4 ugers behandling.
English: Secondary endpoints (weeks 20-24)
Danish: Sekundære endepunkter (uge 20-24)
English: • Protected from sunlight
Danish: • beskyttes mod sollys
English: PRESS HERE TO OPEN
Danish: TRYK HER FOR AT ÅBNE
English: Yellow indicator (becomes visible when the injection is complete)
Danish: Gul indikator (bliver synlig, når injektionen er fuldført)
English: Anaphylaxis**
Danish: Anafylaksi**
English: Find a comfortable, well-lit and clean surface.
Danish: Find en egnet, veloplyst og ren overflade.
English: If you do not notice that you have missed a dose until it is already time for your next dose, then just inject the next dose as planned.
Danish: Hvis du ikke bemærker, at du har glemt en dosis, inden det er tid til din næste dosis, skal du blot injicere den næste dosis som planlagt.
English: Then lift the pen away from your skin.
Danish: Løft derefter pennen væk fra din hud.
English: Local injection site reactions occurred mainly at the start of treatment and within the first 3 injections with fewer reports on subsequent injections.
Danish: Lokale reaktioner på injektionsstedet forekom primært i starten af behandlingen og inden for de første 3 injektioner med færre rapporteringer ved de efterfølgende injektioner.
English: These reactions may be common (they can affect up to 1 in 10 people).
Danish: Disse reaktioner kan være almindelige (kan forekomme hos op til 1 ud af 10 personer).
English: St. George's Respiratory Questionnaire (SGRQ) at week 32
Danish: St. Georges Respiratory Questionnaire (SGRQ) ved uge 32
English: There are no fertility data in humans.
Danish: Der foreligger ingen fertilitetsdata hos mennesker.
English: The potential for interactions with mepolizumab is therefore considered low.
Danish: Potentialet for interaktioner med mepolizumab anses derfor for lav.
English: • The yellow indicator will move down through the inspection window as you receive your dose.
Danish: • Den gule indikator vil bevæge sig ned gennem inspektionsvinduet, mens du får din dosis.
English: Tell your doctor or a nurse immediately if you get any of these symptoms.
Danish: Fortæl det omgående til lægen eller en sygeplejerske, hvis du får nogen af disse symptomer.
English: • Continue to hold the pen in place while you count to 5.
Danish: • Fortsæt med at holde pennen på plads, mens du tæller til 5.
English: Patients continued to receive their existing asthma medicine during the studies.
Danish: Patienterne fortsatte med at få deres nuværende astmamedicin under studierne.
English: • Alcohol wipe (not included)
Danish: • Alkoholserviet (ikke inkluderet)
English: • Take the carton out of the refrigerator.
Danish: • Tag kartonen ud af køleskabet.
English: • You may notice a small drop of blood at the injection site.
Danish: • Du vil muligvis bemærke en lille dråbe blod ved injektionsstedet.
English: After a treatment interruption of 8 weeks, 30 of these patients, received mepolizumab for a further 52 weeks.
Danish: Efter en behandlingsafbrydelse på 8 uger, fik 30 af disse patienter mepolizumab i yderligere 52 uger.
English: Examinations for internal or skeletal malformations were not performed.
Danish: Der blev ikke udført undersøgelser for indre eller skeletale misdannelser.
English: Component of a multipack, can't be sold separately.
Danish: Del af multipakning, må ikke sælges enkeltvis.
English: The side effects caused by Nucala are usually mild to moderate but can occasionally be serious.
Danish: De bivirkninger, der forårsages af Nucala, er normalt lette til moderate, men kan i nogle tilfælde være alvorlige.
English: Before administration, the solution should be inspected visually.
Danish: Før administration skal opløsningen inspiceres visuelt.
English: Nucala is intended for long-term treatment.
Danish: Nucala er beregnet til længerevarende behandling.
English: The safety and efficacy of mepolizumab in children less than 6 years old have not yet been established.
Danish: Sikkerhed og virkning af mepolizumab hos børn under 6 år er endnu ikke fastlagt.
English: There is a limited amount of data (less than 300 pregnancy outcomes) from the use of mepolizumab in pregnant women.
Danish: Der er begrænsede data (færre end 300 gravide forsøgspersoner) fra anvendelse af mepolizumab til gravide kvinder.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du får dette lægemiddel, da den indeholder vigtige oplysninger.
English: These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e., typically within several days).
Danish: Disse reaktioner opstår normalt inden for timer efter administration, men er i nogle tilfælde indtrådt senere (dvs. typisk efter flere dage).
English: Other side effects include: Very common side effects
Danish: Andre bivirkninger omfatter: Meget almindelige bivirkninger
English: Do not touch the yellow needle guard with your fingers.
Danish: Du må ikke røre den gule kanylebeskyttelse med dine fingre.
English: Alternatively, another person can inject in your upper arm
Danish: Alternativt kan en anden person injicere dig i din overarm
English: * Systemic reactions including hypersensitivity have been reported at an overall incidence comparable to that of placebo.
Danish: *Systemiske reaktioner, herunder overfølsomhed, er blevet rapporteret med en samlet incidens, der var sammenlignelig med incidensen for placebo.
English: Reconstitution should be carried out under aseptic conditions.
Danish: Rekonstitueringen skal udføres under aseptiske forhold.
English: The mean number of exacerbations in the previous year was 3.6 and the mean predicted pre-bronchodilator FEV1 was 60%.
Danish: Det gennemsnitlige antal eksacerbationer i det foregående år var 3,6, og den gennemsnitlige præ-bronkodilatator FEV1 var 60 %.
English: For children aged 6-11 years, contact your doctor who will prescribe the recommended dose of Nucala which will be administered by a nurse or doctor.
Danish: For børn i alderen 6 - 11 år skal du kontakte din læge, der vil ordinere den anbefalede dosis Nucala, som skal gives af en sygeplejerske eller læge.
English: The frequency of adverse reactions is defined 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
Danish: Bivirkningsfrekvensen er defineret efter følgende konvention: 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
English: - If you are not sure, hold the pen down for another 15 seconds to make sure the injection is complete.
Danish: - Hvis du ikke er sikker, skal du holde pennen nede i yderligere 15 sekunder for at sikre, at injektionen er fuldført.
English: The following information is intended for healthcare professionals only: Step-by-step instructions for use and handling, reconstitution, and administration
Danish: Nedenstående oplysninger er kun til læger og sundhedspersonale: Trin-for-trin instruktioner i brug og håndtering, rekonstitution og administration
English: Exp: Month-Year
Danish: EXP: Måned-År
English: This dosing regimen is considered acceptable due to the wide therapeutic index of mepolizumab.
Danish: Dette doseringsregime anses for acceptabelt på grund af det brede terapeutiske indeks for mepolizumab.
English: Prepare 1.
Danish: Klargør 1.
English: Following repeat subcutaneous administration every 4 weeks, there is approximately a two-fold accumulation at steady state.
Danish: Efter gentagen subkutan administration hver 4. uge er der en omtrent fordoblet akkumulation ved steady state.
English: The yellow needle guard will slide up into the pen.
Danish: Den gule kanylebeskyttelse vil glide op i pennen.
English: Administration of Nucala to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Danish: Administration af Nucala til gravide kvinder bør kun overvejes, hvis den forventede fordel for moderen overstiger den mulige risiko for fostret.
English: Predefined categories included percent reductions ranging from 90-100% reduction, to no decrease in the prednisone dose from the end of the optimisation phase.
Danish: De foruddefinerede kategorier var reduktioner i procent, der gik fra en reduktion på 90-100 % til ingen reduktion af prednisondosis fra afslutningen af optimeringsfasen.
English: If you are pregnant, if you think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
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 du får dette lægemiddel.
English: Do not let the needle touch any surface.
Danish: Du må ikke lade kanylen røre nogen overflade.
English: Press down
Danish: Tryk ned
English: • Inject straight after removing the needle cap, and always within 5 minutes.
Danish: • Injicér lige efter fjernelse af kanylehætten, og altid inden for 5 minutter.
English: Pre-bronchodilator FEV1 (mL) at week 32
Danish: Præ-bronkodilatator FEV1 (ml) ved uge 32
English: A total of 135 patients were enrolled: mean age was 50 years, 55% were female, and 48% had been receiving oral steroid therapy for at least 5 years.
Danish: Der blev inkluderet i alt 135 patienter: gennemsnitsalderen var 50 år, 55 % var kvinder, og 48 % havde fået orale steroider i mindst 5 år.
English: • swelling of eyelids, face, lips, tongue or mouth
Danish: • hævelse af øjenlåg, ansigt, læber, tunge eller mund
English: As a precautionary measure, it is preferable to avoid the use of Nucala during pregnancy.
Danish: Som en sikkerhedsforanstaltning anbefales det at undgå at bruge Nucala under graviditet.
English: They usually occur within minutes to hours after the injection, but sometimes symptoms can start up to several days later.
Danish: De opstår normalt inden for minutter til timer efter injektionen, men nogle gange kan symptomerne starte op til flere dage efter injektionen.
English: Administration-related reactions (systemic non allergic)***
Danish: Injektionsrelaterede reaktioner (systemiske ikke-allergiske)***
English: IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation and survival of eosinophils.
Danish: IL-5 er det cytokin, der primært er ansvarligt for væksten og differentieringen, rekrutteringen, aktiveringen og overlevelsen af eosinofile celler.
English: • Keep refrigerated before use.
Danish: • Opbevares på køl før brug.
English: This could cause a needle injury.
Danish: Dette kan medføre kanyleskader.
English: No children had detectable anti-mepolizumab antibodies during the long-term phase of the study.
Danish: Ingen børn havde målbare anti-mepolizumab-antistoffer i den længerevarende fase af studiet.
English: Children aged 6 to 11 years old
Danish: Børn fra 6 til 11 år
English: Some people with severe asthma have too many eosinophils (a type of white blood cell) in the blood and lungs.
Danish: Nogle personer med svær astma har for mange eosinofile celler (en type hvide blodceller) i blodet og lungerne.
English: Check the medicine
Danish: Kontrollér medicinen
English: The absolute subcutaneous bioavailability appears complete compared to that observed in adults and adolescents of 76%.
Danish: Den absolutte subkutane biotilgængelighed forekommer fuldstændig sammenlignet med den observerede biotilgængelighed hos voksne og unge på 76 %.
English: • Continue to hold the pen down until you hear the 2nd “click”, and the stopper and yellow indicator have stopped moving and fill the inspection window.
Danish: • Fortsæt med at holde pennen nede, indtil du hører det andet ”klik”, og proppen og den gule indikator er stoppet med at bevæge sig og fylder inspektionsvinduet.
English: Human Genome Sciences, Inc. 9911 Belward Campus Drive Rockville, MD 20850
Danish: Human Genome Sciences, Inc. 9911 Belward Campus Drive Rockville, MD 20850 USA
English: These events were all non-serious, mild to moderate in intensity and the majority resolved within a few days.
Danish: Reaktionerne var alle ikke-alvorlige, lette til moderate i sværhedsgrad, og hovedparten forsvandt inden for få dage.
English: • Insert the entire needle into the pinched skin at a 45° angle, as shown.
Danish: • Indsæt hele kanylen i den klemte hud i en vinkel på 45°, som vist.
English: Inspection window
Danish: Inspektionsvindue
English: These reactions may occur for the first time after a long duration of treatment (see section 4.8).
Danish: Disse reaktioner kan forekomme første gang efter længere tids behandling (se pkt.
English: 1st “Click”
Danish: Første “klik”
English: The comparison between mepolizumab and placebo was statistically significant (p=0.008).
Danish: Sammenligningen mellem mepolizumab og placebo var statistisk signifikant (p=0,008).
English: Chemical and physical stability of the reconstituted medicinal product have been demonstrated for 8 hours when stored below 30°C.
Danish: Kemisk og fysisk stabilitet af det rekonstituerede lægemiddel er vist i 8 timer ved temperaturer under 30 °C.
English: Children less than 6 years old
Danish: Børn under 6 år
English: Dispose of the remaining solution.
Danish: Kassér den resterende opløsning.
English: Inspection window (medicine inside)
Danish: Inspektionsvindue (medicin indeni)
English: The need for continued therapy should be considered at least on an annual basis as determined by physician assessment of the patient's disease severity and level of control of exacerbations.
Danish: Behovet for fortsat behandling bør som minimum overvejes en gang årligt på baggrund af lægens vurdering af sygdommens sværhedsgrad, og på hvilket niveau patientens eksacerbationer kontrolleres.
English: If you are taking medicines called oral corticosteroids, Nucala can also help reduce the daily dose you need to control your asthma.
Danish: Hvis du tager lægemidler, der kaldes orale kortikosteroider, kan Nucala også hjælpe med at nedsætte den daglige dosis, som du behøver for at holde din astma under kontrol.
English: Do not expel any air bubbles from the syringe.
Danish: Du må ikke udstøde nogen luftbobler fra sprøjten.
English: In monkeys, mepolizumab had no effect on pregnancy or on embryonic/fetal and postnatal development (including immune function) of the offspring.
Danish: Hos aber havde mepolizumab ingen effekt på drægtigheden eller på den embryonale/føtale og postnatale udvikling (herunder immunfunktion) af afkommet.
English: Subcutaneous use after reconstitution.
Danish: Subkutan anvendelse efter rekonstitution.
English: The proportion of patients on maintenance OCS was 31% and 24%, respectively.
Danish: Andelen af patienter, som fik vedligeholdelsesbehandling med OCS, var henholdsvis 31 % og 24 % i de to studier.
English: If a mechanical reconstitution device (swirler) is used to reconstitute Nucala, reconstitution can be accomplished by swirling at 450 rpm for no longer than 10 minutes.
Danish: Hvis der benyttes mekanisk apparatur (swirler) til at rekonstituere Nucala, kan rekonstitutionen gennemføres ved at rotere ved 450 rpm i højst 10 minutter.
English: Nucala may weaken your resistance to infections caused by parasites.
Danish: Nucala kan nedsætte din modstandskraft mod infektioner forårsaget af parasitter.
English: • Move your thumb to the plunger and place your fingers on the white finger grip, as shown.
Danish: • Flyt din tommelfinger til stemplet og placér dine fingre på det hvide fingergreb, som vist.
English: Do not lift the pen from your skin at this stage, as that may mean you don't get your full dose of medicine.
Danish: Du må ikke løfte pennen fra din hud på dette tidspunkt, da det kan medføre, at du ikke får din fulde dosis medicin.
English: Alternatively, swirling at 1000 rpm for no longer than 5 minutes is acceptable.
Danish: Alternativt er det acceptabelt at rotere ved 1.000 rpm i højst 5 minutter.
English: Other medicines for asthma
Danish: Andre lægemidler mod astma
English: If not used immediately, in-use storage times and conditions are the responsibility of user.
Danish: Anvendelse af andre opbevaringstider ogbetingelser er på brugerens eget ansvar.
English: Nucala may be self-administered by the patient or administered by a caregiver if their healthcare professional determines that it is appropriate, and the patient or caregiver are trained in injection techniques.
Danish: Nucala kan selvadministreres af patienten eller administreres af en plejeperson, hvis lægen vurderer, at det er hensigtsmæssigt, og hvis patienten eller plejepersonen er trænet i injektionsteknik.
English: • Use your free hand to pinch the skin around your injection site.
Danish: • Brug din frie hånd til at klemme huden omkring dit injektionssted.
English: • Slowly lift your thumb up.
Danish: • Løft langsomt din tommelfinger op.
English: Hypersensitivity reactions (systemic allergic)*
Danish: Overfølsomhedsreaktioner (systemiske allergiske)*
English: Primary endpoint Percent reduction in OCS from baseline (weeks 20-24)
Danish: Primært endepunkt Procent reduktion i OCS i forhold til baseline (uge 20-24)
English: Following reconstitution, Nucala should be visually inspected for particulate matter and clarity prior to use.
Danish: Efter rekonstitution skal Nucala inspiceres visuelt for partikler og uklarhed før brug.
English: Your doctor or nurse will decide if you or your caregiver can inject Nucala.
Danish: Din læge eller sygeplejerske vil afgøre, om du eller din plejeperson kan injicere Nucala.
English: You or your caregiver should inject the next dose of Nucala as soon as you remember.
Danish: Du eller din plejeperson skal injicere den næste dosis Nucala, så snart du kommer i tanke om det.
English: • eczema (itchy red patches on the skin)
Danish: • eksem (kløende røde pletter på huden)
English: Concentrations of mepolizumab were about 1.2-2.4 times higher in infants than in mothers for several months post partum and did not affect the immune system of the infants.
Danish: Mepolizumabkoncentrationerne var ca. 1,2-2,4 gange højere hos afkommet end hos mødrene i flere måneder efter fødslen, men påvirkede ikke immunsystemet hos afkommet.
English: Check with your doctor if you think this applies to you.
Danish: Fortæl det til lægen, hvis du mener, at dette gælder for dig.
English: Frequency of exacerbations requiring hospitalisation
Danish: Hyppighed af eksacerbationer, der kræver hospitalsindlæggelse
English: Reconstitution is typically complete within 5 minutes after the sterile water has been added, but it may take additional time.
Danish: Rekonstitutionen er normalt færdig i løbet af 5 minutter, efter at det sterile vand er blevet tilsat, men det kan tage længere tid.
English: • Gauze pad or cotton wool ball (not included) Do not perform the injection if you do not have all these.
Danish: • Et stykke vat eller gaze (ikke inkluderet) Du må ikke udføre injektionen, hvis du ikke har alt dette.
English: Press a cotton wool ball or gauze on the area for a few moments if necessary.
Danish: Tryk om nødvendigt et stykke vat eller gaze på området i lidt tid.
English: Dose-ranging efficacy MEA112997 (DREAM) study
Danish: Dosis-effekt studie MEA112997 (DREAM)
English: Nucala can reduce your number of asthma attacks, if you or your child are already using medicines such as high dose inhalers, but your asthma is not well controlled by these medicines.
Danish: Nucala kan nedsætte antallet af dine astmaanfald, hvis du eller dit barn allerede bruger lægemidler mod astma, for eksempel højdosis-inhalatorer, men hvor disse lægemidler ikke holder din astma under kontrol.
English: Make sure the white plunger is fully down
Danish: Sørg for, at det hvide stempel er helt i bund
English: These patients either remained uncontrolled (at least two severe exacerbations in the previous 12 months) on their current standard of care, including at least high doses of inhaled corticosteroids (ICS) plus an additional maintenance treatment(s), or were dependent on systemic corticosteroids.
Danish: Disse patienter forblev enten ukontrollerede (mindst to svære eksacerbationer i de forudgående 12 måneder) på deres nuværende standardbehandling, som mindst omfattede høje doser af inhalationssteroider (ICS) plus yderligere en eller flere vedligeholdelsesbehandling(er), eller var afhængige af systemiske kortikosteroider.
English: - if you are allergic to mepolizumab or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for mepolizumab eller et af de øvrige indholdsstoffer i Nucala (angivet i punkt 6).
English: Animal toxicology and/or pharmacology
Danish: Toksikologi og/eller farmakologi hos dyr
English: • Slowly push down on the plunger to inject your full dose.
Danish: • Tryk langsomt ned på stemplet for at injicere din fulde dosis.
English: There are limited data available in patients with creatinine clearance values <50 mL/min.
Danish: Der er begrænsede data tilgængelige fra patienter med kreatininclearance < 50 ml/min.
English: Table 4: Results of the primary and secondary endpoints in MEA115575
Danish: Tabel 4: Resultater for de primære og sekundære endepunkter i MEA115575
English: Consistent with the potentially immunogenic properties of protein and peptide therapeutics, patients may develop antibodies to mepolizumab following treatment.
Danish: I overensstemmelse med de potentielt immunogene egenskaber ved protein- og peptidlægemidler kan patienterne udvikle antistoffer mod mepolizumab i forbindelse med behandling.
English: For instructions on the reconstitution of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om rekonstitution af lægemidlet før administration, se pkt.
English: Reduction in corticosteroid doses, if required, should be gradual and performed under the supervision of a physician.
Danish: Hvis reduktion af kortikosteroiddosis er nødvendig, bør det ske gradvist under supervision af en læge.