FrancophonIA/ELRC3.0 huggingface dataset:
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 (<1/10,000); and not known (cannot be estimated from available data).
Danish: Bivirkningernes hyppighed 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 (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The overall adverse event profile was similar to the asthma trials described above.
Danish: Den generelle bivirkningsprofil var ikke anderledes end for astmastudierne beskrevet ovenfor.
English: The green needle guard is now exposed.
Danish: Den grønne nålesikring er nu synlig.
English: It binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with high affinity and specificity.
Danish: Det binder sig til alfa-underenheden af den humane interleukin-5-receptor (IL-5Rα) med høj affinitet og specificitet.
English: • the expiry date (EXP) has passed
Danish: • udløbsdatoen (EXP) er overskredet
English: Its colour may vary from colourless to yellow.
Danish: Farven kan variere fra farveløs til gul.
English: Median percent reductions in daily OCS over time (Trial 3 and 4)
Danish: Median procentvis reduktion i daglig OCS over tid (studie 3 og 4)
English: Do not touch the cleaned area before injecting.
Danish: Rør ikke det rensede område før injektion.
English: Insert the needle at an angle of 45 degrees.
Danish: Indsæt nålen i en vinkel på 45 grader.
English: Fasenra is intended for long-term treatment.
Danish: Fasenra er beregnet til langtidsbehandling.
English: You can either gently pinch at the injection site or give the injection without pinching the skin.
Danish: Du kan enten forsigtigt klemme på injektionsstedet, eller give injektionen uden at klemme om huden.
English: If your asthma symptoms get worse while receiving injections of Fasenra, call your doctor.
Danish: Hvis dine astmasymptomer bliver værre, mens du får injektioner af Fasenra, skal du kontakte lægen.
English: Check the viewing window to make sure all the liquid has been injected.
Danish: Tjek vinduet for at sikre, at al opløsning er blevet injiceret.
English: Check the expiry date (EXP).
Danish: Tjek udløbsdatoen (EXP).
English: The green plunger will move down in the viewing window during the injection.
Danish: Det grønne stempel vil bevæge sig ned i vinduet under injektionen
English: If a dose of Fasenra is missed
Danish: Hvis en dosis Fasenra er blevet glemt
English: The recommended dose is an injection of 30 mg.
Danish: Den anbefalede dosis er en injektion på 30 mg.
English: The estimated systemic clearance (CL) for benralizumab was at 0.29 L/d.
Danish: Den estimerede systemiske clearance (CL) for benralizumab var 0,29 l/d.
English: Do not inject:
Danish: Du må ikke injicere:
English: No conclusion can be drawn regarding asthma efficacy in the paediatric population.
Danish: Der kan ikke drages nogen konklusioner om effekten på astma i den pædiatriske population.
English: Clean the injection site with an alcohol wipe in a circular motion.
Danish: Rens injektionsstedet med en spritserviet i en cirkulær bevægelse.
English: Subgroup analyses from Trials 1 and 2 identified patients with higher prior exacerbation history as a potential predictor of improved treatment response.
Danish: Subgruppeanalyser fra Studie 1 og 2 identificerede patienter med tidligere flere eksacerbationer i anamnesen som potentiel prædiktor af forbedret behandlingsrespons.
English: Do not touch the needle, or let it touch any surface.
Danish: Rør ikke ved nålen, og lad den ikke røre ved nogen overflade.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX10
Danish: Farmakoterapeutisk klassifikation: Lægemidler til obstruktive luftvejssygdomme, andre systemiske lægemidler til obstruktive luftvejssygdomme, ATC-kode: R03DX10
English: Patients with known helminth infections were excluded from participation in clinical trials.
Danish: Patienter med kendte helminth-infektioner blev udelukket fra at deltage i de kliniske studier.
English: Exacerbation rate requiring hospitalisation/emergency room visit
Danish: Eksacerbationsfrekvens, der krævede hospitalsindlæggelse/skadestuebesøg
English: Use a quick, dart-like motion to insert the needle into the pinched skin.
Danish: Brug en hurtig, kort bevægelse for at sætte nålen ind i den sammenklemte hud.
English: You could cause the injection to happen too soon or damage the needle.
Danish: Du kan få injiceringen til at ske for hurtigt eller beskadige nålen.
English: In addition, change from baseline in mean FEV1 showed benefit as early as 4 weeks, which was maintained through to end of treatment (Table 2).
Danish: Desuden viste ændringen fra baseline i gennemsnitlig FEV1 forbedringer så tidligt som 4 uger, hvilket blev opretholdt til slutningen af behandlingen (Tabel 2).
English: You and your doctor or nurse should decide if you should inject Fasenra yourself.
Danish: Du og din læge eller sygeplejerske skal beslutte, om du skal injicere Fasenra selv.
English: Maintenance of the reduction in daily OCS dose was also observed over the extension trial in patients enrolled from Trial 3 (Figure 1).
Danish: Vedligeholdelse af reduktionen i den daglige OCS-dosis blev også observeret i forlængelsesstudierne hos patienter inkluderet fra studie 3 (figur 1).
English: In Trial 2, there were too few events in the placebo treatment arm to draw conclusions for exacerbations requiring hospitalisation or emergency room visits.
Danish: I Studie 2 var der for få hændelser i placebobehandlingsarmen til at drage konklusioner for eksacerbationer, som krævede hospitalsindlæggelse eller skadestuebesøg.
English: It is preferable to avoid the use of Fasenra during pregnancy.
Danish: Fasenra bør undgås under graviditeten.
English: This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
Danish: Disse oplysninger erstatter ikke, at du taler med din læge om din medicinske tilstand eller din behandling.
English: The trial included an 8-week run-in period during which the OCS was titrated to the minimum effective dose without losing asthma control.
Danish: Studiet omfattede en 8-ugers indkøringsperiode, hvor OCS blev titreret til den mindste effektive dosis uden at astmakontrollen gik tabt.
English: Place the needle guard of the Fasenra Pen flat against your skin (90-degree angle).
Danish: Placer nålesikringen på Fasenra Pen fladt mod din hud (90 graders vinkel).
English: The needle guard will slide down and lock into place over the needle.
Danish: Nålesikringen glider ned og låses på plads over nålen.
English: You or your caregiver should receive training on the right way to prepare and inject Fasenra.
Danish: Du eller din omsorgsperson skal oplæres i den rigtige måde at forberede og injicere Fasenra.
English: You may see a small air bubble in the liquid.
Danish: Du kan måske se en lille luftboble i væsken.
English: Eosinophil depletion does not produce chronic systemic alterations of proinflammatory cytokines.
Danish: Eosinofil depletion fremkalder ingen kroniske systemiske ændringer af proinflammatoriske cytokiner.
English: Self-administration should only be considered in patients already experienced with Fasenra treatment.
Danish: Selv-administration bør kun overvejes hos patienter, der allerede har erfaring med behandling med Fasenra.
English: Only patients with an optimised baseline OCS dose of 12.5 mg or less were eligible to achieve a 100% reduction in OCS dose during the study.
Danish: Kun patienter med en optimeret baseline-OCS-dosis på 12,5 mg eller mindre var egnede til at få en reduktion af OCS-dosis på 100 % under studiet.
English: The IL-5 receptor is specifically expressed on the surface of eosinophils and basophils.
Danish: IL-5-receptoren er specifikt udtrykt på overfladen af eosinofilocytter og basofilocytter.
English: e. Baseline is prior to Fasenra treatment in Trial 1 and 2.
Danish: e. Baseline er forud for Fasenra-behandling i studie 1 og 2.
English: Trial 3 evaluated the effect of Fasenra on reducing the use of maintenance oral corticosteroids.
Danish: Studie 3 evaluerede virkningen af Fasenra på reduktion i anvendelsen af vedligeholdelsesbehandling med orale kortikosteroider.
English: c. Integrated analysis at End of Treatment (EOT) of Trial 1(Week 48) and Trial 2 (Week 56).
Danish: c. Integreret analyse ved behandlingens afslutning (EOT) i studie 1 (uge 48) og studie 2 (uge 56).
English: Asthma symptom scale: total score from 0 (least) to 6 (most); day and night time asthma symptom scores from 0 (least) to 3 (most) symptoms.
Danish: Astmasymptomskala: total score fra 0 (færrest) til 6 (flest); astmasymptomscore dag og nat fra 0 (færrest) til 3 (flest) symptomer.
English: Following subcutaneous administration to patients with asthma, the absorption half-life was 3.5 days.
Danish: Efter subkutan administration til patienter med astma var absorptionshalveringstiden 3,5 dage.
English: The trial enrolled 2123 patients, 2037 adults and 86 adolescent patients (aged 12 years and older) from Trials 1, 2 and 3.
Danish: Studiet inkluderende 2123 patienter, 2037 voksne og 86 unge patienter (12 år og ældre) fra studie 1, 2 og 3.
English: Do not remove the cap until you have reached Step 6.
Danish: Fjern ikke hætten før du er nået til trin 6.
English: Inject Fasenra by following the steps in figures a, b, c and d.
Danish: Injicer Fasenra ved at følge trinene i figur a, b, c og d.
English: For patients on maintenance oral corticosteroids, this was defined as a temporary increase in stable oral/systemic corticosteroids for at least 3 days or a single depo-injectable dose of corticosteroids.
Danish: For patienter på vedligeholdelsesbehandling med orale kortikosteroider blev dette defineret som en midlertidig stigning i stabile orale/systemiske kortikosteroider i mindst 3 dage eller en enkelt injicerbar dosis af kortikosteroider i depotformulering.
English: The recommended injection site is the front of your thigh.
Danish: Det anbefalede injektionssted er foran på låret.
English: • into scars or damaged skin
Danish: • i ar eller beskadiget hud
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from using Fasenra taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller brug af Fasenra skal seponeres/undlades, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Effect of Fasenra on OCS dose reduction, Trial 3
Danish: Virkning af Fasenra på OCS-dosisreduktion, Studie 3
English: The primary endpoint was percent reduction from baseline of the final OCS dose during Weeks 24 to 28, while maintaining asthma control.
Danish: Det primære endepunkt var procentvis reduktion fra baseline af den endelige OCS-dosis i uge 24 til 28, mens astmakontrollen opretholdes.
English: Benralizumab has not been studied in children (5 to 11 years old) (see section 4.2).
Danish: Benralizumab er ikke undersøgt hos børn (5 til 11 år) (se pkt.
English: Fasenra treatment should be initiated by a physician experienced in the diagnosis and treatment of severe asthma.
Danish: Behandling med Fasenra bør initieres af en læge med erfaring i diagnosticering og behandling af svær astma.
English: Let Fasenra warm up at room temperature 20°C to 25°C for about 30 minutes before giving the injection.
Danish: Lad Fasenra varme op til stuetemperatur 20°C til 25°C i ca. 30 minutter før injektionen gives.
English: Do not expose to heat.
Danish: Må ikke udsættes for varme.
English: Do not fan or blow on the cleaned area.
Danish: Vift eller pust ikke på det rensede område.
English: • if you have any symptoms of an allergic reaction (see section 4).
Danish: • hvis du har symptomer på en allergisk reaktion (se afsnit 4).
English: Use your other hand to gently pinch and hold the area of skin where you want to inject.
Danish: Brug den anden hånd til forsigtigt at klemme om og holde det område af huden, hvor du vil injicere.
English: The long-term efficacy and safety of Fasenra was evaluated in a phase 3, 56-week extension trial BORA (Trial 4).
Danish: Den langsigtede effekt og sikkerhed af Fasenra blev vurderet i et 56 ugers fase 3-forlængelsesstudie BORA (Studie 4).
English: Fasenra is given as an injection just under the skin (subcutaneously).
Danish: Fasenra gives som en injektion lige under huden (subkutant).
English: Disposal guidelines
Danish: Retningslinjer for bortskaffelse
English: Do not touch the needle guard activation clips to keep from activating the safety device (needle guard) too soon.
Danish: Undgå at berøre aktiveringsklipsen til nålesikring for at undgå at aktivere sikkerhedsanordningen (nålesikringen) for tidligt.
English: Driving and using machines It is unlikely that Fasenra will affect your ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt, at Fasenra vil påvirke din evne til at køre og betjene maskiner.
English: Pre-bronchodilator FEV1 (L)
Danish: Præ-bronkodilator FEV1 (l)
English: There is no specific treatment for an overdose with benralizumab.
Danish: Der findes ingen specifik behandling af en overdosering af benralizumab.
English: Fasenra may reduce the number of asthma attacks you are experiencing, help you breathe better and decrease your asthma symptoms.
Danish: Fasenra kan reducere antallet af astmaanfald, som du får, hjælpe dig til en bedre vejrtrækning og mindske astmasymptomerne.
English: Do not press down on the plunger until the needle is completely inserted into the skin.
Danish: Tryk ikke på stemplet, før nålen er helt indsat i huden.
English: Proportional odds model (sensitivity analysis) Percent reduction in OCS from baseline at Week 28 ≥90% reduction ≥75% reduction ≥50% reduction >0% reduction
Danish: Proportionel odds-model (sensitivitetsanalyse) Procentvis reduktion i OCS fra baseline ved uge 28 ≥ 90 % reduktion ≥ 75 % reduktion ≥ 50 % reduktion > 0 % reduktion
English: * Pharyngitis was defined by the following grouped preferred terms: ‘Pharyngitis', ‘Pharyngitis bacterial', ‘Viral pharyngitis', ‘Pharyngitis streptococcal'.
Danish: * Pharyngitis blev defineret efter følgende grupperede foretrukne termer: "Pharyngitis", "Bakteriel pharyngitis", "Viral pharyngitis" og "Streptokok-pharyngitis".
English: If patients become infected, while receiving treatment with Fasenra and do not respond to anti-helminth treatment, treatment with Fasenra should be discontinued until infection resolves.
Danish: Hvis patienterne bliver smittet, mens de får behandling med Fasenra og de ikke reagerer på anti-helminth-behandling, skal behandling med Fasenra seponeres, indtil infektionen er bekæmpet.
English: Trial 1 & 2 Baseline
Danish: Studie 1 & 2 Baseline
English: It is unknown whether benralizumab or its metabolites are excreted in human or animal milk.
Danish: Det er ukendt, om benralizumab eller dets metabolitter udskilles i human mælk eller mælk hos dyr.
English: • into the 5 cm area around your belly-button
Danish: • indenfor et område på 5 cm rundt om navlen
English: Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology or repeated dose toxicity studies in monkeys.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi eller toksicitet efter gentagne doser til aber.
English: It is unknown if Fasenra may influence a patient's response against helminth infections.
Danish: Det er ikke kendt, om Fasenra kan påvirke en patients respons på helminth-infektioner.
English: • If you are allergic to benralizumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for benralizumab eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: Fasenra is administered as a subcutaneous injection.
Danish: Fasenra administreres som en subkutan injektion.
English: Paediatric population The safety and efficacy of Fasenra in children aged 6 to 18 years have not been established.
Danish: Pædiatrisk population Fasenras sikkerhed og virkning hos børn i alderen 6 til 18 år er ikke klarlagt.
English: Keep Fasenra and all medicines out of the sight and reach of children.
Danish: Hold Fasenra og alle lægemidler ude af syne og rækkevidde for børn.
English: You may see a drop of liquid at the end of the needle.
Danish: Du kan måske se en dråbe væske ved nålens ende.
English: Do not use Fasenra:
Danish: Brug ikke Fasenra:
English: Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of benralizumab.
Danish: Cytokrom P450-enzymer, efflukspumper og proteinbindende mekanismer er ikke involveret i clearance af benralizumab.
English: EU/1/17/1252/001 1 pre-filled syringe EU/1/17/1252/002 1 pre-filled pen
Danish: EU/1/17/1252/001 1 præ-fyldt injektionssprøjte EU/1/17/1252/002 1 præ-fyldt pen
English: Do not try to touch the needle or push on the needle guard with your finger.
Danish: Forsøg ikke at berøre nålen eller trykke på nålesikringen med fingeren.
English: A total of 2,514 patients, out of whom 1,663 patients had severe uncontrolled eosinophilic asthma, received benralizumab during clinical studies of 48 to 56 weeks duration.
Danish: I alt 2.514 patienter, hvoraf 1.663 patienter havde svær ukontrolleret eosinofil astma, fik benralizumab i kliniske studier af 48 til 56 ugers varighed.
English: ** Hypersensitivity reactions were defined by the following grouped preferred terms: ‘Urticaria', ‘Papular urticaria', and ‘Rash'.
Danish: ** Overfølsomhedsreaktioner blev defineret efter følgende grupperede foretrukne termer: "Urticaria", "Papuløs urticaria" og "Udslæt".
English: The absence of fucose in the Fc domain of benralizumab results in high affinity for FcɣRIII receptors on immune effector cells such as natural killer (NK) cells.
Danish: Fraværet af fucose i Fc-domænet for benralizumab medfører høj affinitet for FcɣRIII-receptorer på immun-effektorceller såsom naturlige dræberceller, NK-celler (natural killer cells).
English: You should not inject Fasenra yourself if you have not received Fasenra previously and if you had previous allergic reaction with Fasenra.
Danish: Du må ikke selv injicere Fasenra, hvis du ikke tidligere har fået behandling med Fasenra, og hvis du tidligere har haft en allergisk reaktion i forbindelse med Fasenra.
English: Eosinophils may be involved in the immunological response to some helminth infections.
Danish: Eosinofilocytter kan være involveret i det immunologiske respons over for nogle helminth-infektioner.
English: Treatment with benralizumab results in near complete depletion of blood eosinophils within 24 hours following the first dose which is maintained throughout treatment.
Danish: Behandling med benralizumab resulterer i næsten fuldstændig depletion af eosinofilocytter i blodet inden for 24 timer efter den første dosis, hvilket opretholdes under hele behandlingen.
English: In this study there was a median reduction from baseline in airway mucosa eosinophils of 96% in the benralizumab treated group compared to a 47% reduction in the placebo group (p=0.039).
Danish: I dette studie var den en median reduktion fra baseline i eosinofilocytter i luftvejenes slimhinder på 96 % i gruppen, der blev behandlet med benralizumab, sammenlignet med en 47 % reduktion i placebogruppen (p=0,039).
English: Inject Fasenra by following the steps in figures a, b and c.
Danish: Injicer Fasenra ved at følge trinene i figur a, b og c.
English: Throw away the cap and other used supplies in your household waste.
Danish: Smid hætten og andre brugte dele ud med dit husholdningsaffald.
English: Step 7 - Inject Fasenra
Danish: Trin 7 - Injicer Fasenra
English: Fasenra has no or negligible influence on the ability to drive and use machines.
Danish: Fasenra påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: In a randomized, double-blind parallel-group study of 103 patients aged between 12 and 21 years with severe asthma, the humoral antibody responses induced by seasonal influenza virus vaccination do not appear to be affected by benralizumab treatment.
Danish: I et randomiseret, dobbeltblindet parallelgruppestudie med 103 patienter i alderen mellem 12 og 21 år med svær astma, synes det humorale antistofrespons, der induceres ved vaccination mod sæsoninfluenza, ikke at blive påvirket af behandling med benralizumab.
English: Lift the Fasenra Pen straight up.
Danish: Løft Fasenra Pen lige op.
English: The green plunger will fill the viewing window.
Danish: Det grønne stempel udfylder vinduet.
English: In both Trials 1 and 2, patients receiving Fasenra experienced statistically significant reductions in asthma symptoms (Total Asthma Score) compared to patients receiving placebo.
Danish: I både Studie 1 og 2 oplevede patienterne, der fik Fasenra, statistisk signifikante reduktioner i astmasymptomer (total astmascore) i sammenligning med patienter, der fik placebo.
English: The liquid should be clear and colourless to yellow.
Danish: Opløsningen skal være klar og farveløs til gul.
English: Before Use
Danish: Før brug
English: There are limited data in paediatric patients (see section 5.1).
Danish: Der er begrænsede data med pædiatriske patienter (se pkt.
English: As benralizumab is a monoclonal antibody, no genotoxicity or carcinogenicity studies have been conducted.
Danish: Da benralizumab er et monoklonalt antistof er der ikke udført nogen studier af genotoksicitet eller karcinogenicitet.
English: Based on population pharmacokinetic analysis, the estimated absolute bioavailability was approximately 59% and there was no clinically relevant difference in relative bioavailability in the administration to the abdomen, thigh, or upper arm.
Danish: Ifølge en farmakokinetisk populationsanalyse var den estimerede absolutte biotilgængelighed ca. 59 %, og der var ingen klinisk relevant forskel i relativ biotilgængelighed ved administration i mave, lår eller overarm.
English: Use Fasenra within 14 days of removing from the refrigerator.
Danish: Brug Fasenra inden for 14 dage efter at det er taget ud af køleskabet.
English: It is not known whether the ingredients of Fasenra can pass into breast milk.
Danish: Det vides ikke, om indholdsstofferne i Fasenra kan passere over i modermælk.
English: For examples of the associated manifestations reported and a description of the time to onset, see section 4.4.
Danish: 4.4 for eksempler på de rapporterede associerede manifestationer samt en beskrivelse af tiden til debut.
English: In the event of a hypersensitivity reaction, Fasenra should be discontinued permanently and appropriate therapy initiated.
Danish: I tilfælde af en overfølsomhedsreaktion bør Fasenra seponeres permanent og passende behandling initieres.
English: Hold the pre-filled syringe in 1 hand as shown.
Danish: Hold den præ-fyldte injektionssprøjte i én hånd som vist.
English: Label with expiration date
Danish: Etiket med udløbsdato
English: Do not try to put the cap back on the Fasenra Pen.
Danish: Forsøg ikke at sætte hætten tilbage på Fasenra Pen.
English: Clinically significant asthma exacerbation was defined as worsening of asthma requiring use of oral/systemic corticosteroids for at least 3 days, and/or emergency department visits requiring use of oral/systemic corticosteroids and/or hospitalisation.
Danish: Klinisk signifikant astmaeksacerbation blev defineret som en forværring af astma, som nødvendiggjorde anvendelse af orale/systemiske kortikosteroider i mindst 3 dage og/eller besøg på skadestuen, der nødvendiggjorde anvendelse af orale/systemiske kortikosteroider og/eller hospitalsindlæggelse.
English: Do not:
Danish: Du må ikke: