FrancophonIA/ELRC3.0 huggingface dataset:
English: Dyspnoea Productive cough Respiratory failure Wheezing
Danish: Produktiv hoste Respirationsinsufficiens Hvæsende vejrtrækning
English: Grade 3 Interrupt BLINCYTO until no more than grade 1 (mild) and for at least 3 days, then restart BLINCYTO at 9 mcg/day.
Danish: Afbryd BLINCYTO, indtil maksimalt grad 1 (mild) og i mindst 3 dage.
English: CR was defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts (platelets > 100,000/microlitre and absolute neutrophil counts [ANC] > 1,000/microlitre).
Danish: a. CR blev defineret som ≤ 5 % blastceller i knoglemarv; ingen tegn på sygdom og fuld genoprettelse af perifere blodtal (trombocytter > 100.000/mikroliter og absolutte neutrofiler [ANC] > 1.000/mikroliter).
English: Grade 3 If clinically relevant, interrupt BLINCYTO until no more than grade 1 (mild), then restart BLINCYTO at 9 mcg/day.
Danish: Afbryd BLINCYTO, hvis det er klinisk relevant, indtil maksimalt grad 1 (mild).
English: Citric acid monohydrate (E330) Trehalose dihydrate Lysine hydrochloride Polysorbate 80
Danish: Citronsyremonohydrat (E330) Trehalosedihydrat
English: POWDER VIAL
Danish: Lever og galdeveje
English: 5 mcg/m2/day
Danish: 5 mikrog/m dag
English: Paraesthesia Seizure
Danish: Kapillær lækagesyndrom
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Udslæt Knogler, led, muskler og bindevæv
English: 11 Rash includes erythema, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular and rash pruritic.
Danish: Udslæt omfatter erythem, udslæt, erytematøst udslæt, generaliseret udslæt, makulært udslæt, makulopapuløst udslæt og kløende udslæt.
English: 15 mcg/m2/day
Danish: 15 mikrog/m dag
English: Viral infectionsa, b Infections - pathogen unspecified a, b
Danish: Infektioneruspecificeret patogen a, b
English: 5.9 months
Danish: 5,9 mdr.
English: e for CR /CRh* [95% CI]
Danish: CRh*, n (%) [95 % CI]
English: • rash
Danish: • rødme
English: b, n (%) [95% CI] CR, n (%) [95% CI] CRh*, n (%) [95% CI] Complete MRD response for CR /CRh*
Danish: Komplet MRD-respons for CR /CRh*c, n1/n2d (%) [95 % CI] CR, n1/n2
English: Overall
Danish: Samlet
English: - Breast-feeding (see section 4.6).
Danish: - Amning (se pkt.
English: In patients with a history or presence of clinically relevant central nervous system (CNS) pathology (see section 4.4), hospitalisation is recommended at a minimum for the first 14 days of the first cycle.
Danish: Hos patienter med anamnestisk eller aktuel klinisk relevant patologi i centralnervesystemet (CNS) (se pkt.
English: Hepatic impairment
Danish: Encefalopati Afasi
English: Not to be sold separately.
Danish: Må ikke sælges separat.
English: Wash your hands thoroughly with soap and water.
Danish: Vask hænderne grundigt med vand og sæbe.
English: Component of a multipack.
Danish: Del af en multipakning.
English: Date of first authorisation: 17 July 2017
Danish: Dato for første markedsføringstilladelse: 17. juli 2017
English: After that, you will need to have an injection every two weeks.
Danish: Herefter skal du have en injektion hver anden uge.
English: Non-responder imputation is used to impute missing data.
Danish: Non-responder imputation anvendes til at tilskrive manglende data.
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Danish: Din læge vil løbende holde øje med din tilstand for at kontrollere, at behandlingen har den ønskede virkning.
English: AMAGINE-1 was conducted in 661 patients.
Danish: AMAGINE-1 blev gennemført med 661 patienter.
English: Q2W = every 2 weeks
Danish: Q2W = hver 2. uge
English: • Kyntheum is for long-term treatment.
Danish: • Kyntheum er til langtidsbehandling.
English: • if you have tuberculosis (TB), have had a positive TB test, or have been in close contact with someone with TB.
Danish: • hvis du har tuberkulose (TB), har haft en positiv TB-test eller har været i tæt kontakt med nogen, der har TB.
English: • Your doctor will decide how much Kyntheum you need and for how long.
Danish: • Din læge vil beslutte, hvor meget Kyntheum du skal have, og hvor længe du skal have det.
English: No serious infections were associated with neutropenia.
Danish: Ingen alvorlige infektioner var associeret med neutropeni.
English: sPGA 0 or 1 Week 12 sPGA 0 or 1 Week 52
Danish: sPGA 0 eller 1 uge 12 sPGA 0 eller 1 uge 52
English: C. Collect all the materials you need
Danish: C. Find alle de ting frem, du skal bruge
English: Infections Kyntheum may increase the risk of infections.
Danish: Infektioner Kyntheum kan øge risikoen for infektioner.
English: Grade 3 and 4 has been observed occasionally.
Danish: Der er lejlighedsvist set grad 3 og 4.
English: • If you want to use the same injection area each time, make sure it is not exactly the same spot that you used for a previous injection.
Danish: • Hvis du vil bruge det samme injektionsområde hver gang, skal du sørge for, at det ikke er præcis samme sted som den tidligere injektion.
English: Only your caregiver can use:
Danish: Kun din omsorgsperson kan bruge:
English: • Do not try to warm the syringe by using a heat source such as hot water or a microwave.
Danish: • Forsøg ikke at opvarme injektionssprøjten ved at bruge en varmekilde såsom varmt vand eller en mikrobølgeovn.
English: Kyntheum has not been tested in pregnant women and it is not known if this medicine can harm your unborn baby.
Danish: Kyntheum er ikke blevet testet hos gravide kvinder, og det vides ikke, om lægemidlet kan skade dit ufødte barn.
English: If you stop treatment, symptoms of psoriasis may come back.
Danish: Hvis du stopper behandlingen, kan symptomerne på psoriasis komme tilbage.
English: *p-value vs. corresponding placebo, adjusted for stratification factors <0.001
Danish: *p-værdi versus tilsvarende placebo, justeret for stratifikationsfaktorer <0,001
English: Kyntheum is not recommended for children and adolescents (below 18 years of age) because it has not been studied in this age group.
Danish: Kyntheum anbefales ikke til børn og unge (under 18 år), da det ikke er blevet undersøgt hos denne aldersgruppe.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal navn og batchnummer på det administrerede produkt registreres tydeligt.
English: • Do not use after the expiry date on the label.
Danish: • Må ikke anvendes efter udløbsdatoen på etiketten.
English: Cover with plaster if needed.
Danish: Sæt om nødvendigt et plaster på.
English: Important: Needle is inside
Danish: Vigtigt: Nålen er indeni
English: • if you have been told you have tuberculosis.
Danish: • hvis du har fået at vide, at du har tuberkulose.
English: Most of these side effects are mild to moderate.
Danish: De fleste af disse bivirkninger er lette til moderate.
English: You should not stop using Kyntheum without speaking to your doctor first.
Danish: Du må ikke holde op med at bruge Kyntheum uden at have talt med din læge først.
English: You or your caregiver can use:
Danish: Du eller din omsorgsperson kan bruge:
English: • if you have an infection now or often get infections
Danish: • hvis du har en infektion nu, eller hvis du tit får infektioner
English: D. Prepare and clean the area where you will inject
Danish: D. Klargør og rens det område, hvor du vil injicere
English: The maintenance phase in AMAGINE-2 and -3 did not include placebo.
Danish: Vedligeholdelsesfasen i AMAGINE-2 og -3 omfattede ikke placebo.
English: However, Kyntheum should not be given to patients with active tuberculosis.
Danish: Kyntheum må dog ikke gives til patienter med aktiv tuberkulose.
English: Due to re-randomisation to other explored dose regimens, n-in maintenance is substantially lower than n-randomised in several arms.
Danish: På grund af genrandomiseringen til andre undersøgte dosisregimer, er n-i vedligeholdelsesbehandling væsentligt lavere end n-randomiseret i flere arme.
English: PASI 75 Week 52 (%)
Danish: PASI 75 uge 12 (%) PASI 75 uge 52 (%)
English: • if you have an infection which your doctor thinks is important (for example, active tuberculosis).
Danish: • hvis du har en infektion, som efter din læges vurdering er af betydning (for eksempel aktiv tuberkulose).
English: No cases of active tuberculosis were reported from clinical trials.
Danish: Der er ikke rapporteret tilfælde af aktiv tuberkulose fra de kliniske forsøg.
English: • sharps disposal container (colour and appearance of container may differ depending on national requirements).
Danish: • kanyleboks (boksens farve og udseende kan variere afhængigt af de nationale krav).
English: Of these patients, none had neutralising antibodies.
Danish: Ingen af disse patienter havde neutraliserende antistoffer.
English: It is recommended that patients be brought up-to-date with all immunisations in accordance with local immunisation guidelines prior to initiation of treatment with Kyntheum.
Danish: Det anbefales, at patienterne bringes ajour med alle immuniseringer i henhold til de lokale immuniseringsretningslinjer, inden behandling med Kyntheum initieres.
English: You should not be given certain types of vaccines (called ‘live vaccines') while being treated with Kyntheum
Danish: Du må ikke få visse typer vacciner (kaldet "levende vacciner"), når du behandles med Kyntheum
English: • if you have used Kyntheum during the last three months of your pregnancy, you should talk to your doctor before vaccinating your baby
Danish: • hvis du har brugt Kyntheum i de sidste tre måneder af graviditeten, skal du kontakte lægen, før dit barn får en vaccination
English: Immediately tell your doctor or seek medical help if you get any signs of a serious infection.
Danish: Du skal straks fortælle det til lægen eller søge lægehjælp, hvis du oplever nogen tegn på en alvorlig infektion.
English: Ustekinumab n-randomised n-completed Week 12 n-in maintenance
Danish: Ustekinumab n-randomiseret n-fuldført uge 12 n-i vedligeholdelsesbehandling
English: Put the box with any unused syringes back in the refrigerator.
Danish: Læg æsken med ubrugte injektionssprøjter tilbage i køleskabet.
English: Step 3: Injecting
Danish: Trin 3: Injektion
English: PSI responder: total score ≤8 with no item scores >1; SD: standard deviation.
Danish: PSI-respondenter: samlet score ≤8 uden nogen score >1; SD: standardafvigelse.
English: The safety and efficacy of Kyntheum in children and adolescents below the age of 18 years have not yet been established.
Danish: Kyntheums sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: Table 2: Overview of the main efficacy results AMAGINE-1
Danish: Tabel 2: Oversigt over primære virkningsresultater AMAGINE-1
English: AMAGINE-2 and AMAGINE-3
Danish: AMAGINE-2 og AMAGINE-3
English: F. Pinch your skin to create a firm surface
Danish: F. Knib huden sammen for at skabe en fast overflade
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 12-16 weeks of treatment.
Danish: Det bør overvejes at seponere behandlingen hos patienter, som ikke har vist respons efter 12-16 ugers behandling.
English: • if you have a long-term (chronic) infection
Danish: • hvis du har en langvarig (kronisk) infektion
English: Exposure-response analysis indicates that higher brodalumab concentrations are related to better PASI and sPGA response.
Danish: En eksponerings-respons-analyse viser, at højere brodalumab-koncentrationer er forbundet med bedre PASI- og sPGA-respons.
English: If you have forgotten to inject a dose of Kyntheum, inject the next dose as soon as you can after the missed dose.
Danish: Hvis du har glemt at injicere en dosis Kyntheum, skal du injicere den næste dosis hurtigst muligt efter den glemte dosis.
English: • Clean the area where you plan to inject with an alcohol wipe.
Danish: • Rens det område, hvor du ønsker at injicere, med en alkoholserviet.
English: H. Using slow and constant pressure, push the plunger all the way down until it stops moving
Danish: H. Skub stemplet helt i bund med et langsomt og konstant tryk, indtil det holder op med at bevæge sig
English: • Keep in the original carton to protect from light or physical damage.
Danish: • Opbevares i den originale karton for at beskytte mod lys eller fysisk skade.
English: • After the first dose you will need to have a weekly injection at Week 1 (one week after the first dose) and Week 2 (two weeks after the first dose).
Danish: • Efter den første dosis skal du have en ugentlig injektion i uge 1 (en uge efter den første dosis) og uge 2 (to uger efter den første dosis).
English: Laboratoires LEO 39 route de Chartres 28500 Vernouillet France
Danish: Laboratoires LEO 39 route de Chartres 28500 Vernouillet Frankrig
English: Pregnancy There are no or limited amount of data from the use of brodalumab in pregnant women.
Danish: Graviditet Der er ingen eller utilstrækkelige data fra anvendelse af brodalumab til gravide kvinder.
English: Your doctor will then help you decide whether to stop breast-feeding or stop using Kyntheum.
Danish: Din læge vil så hjælpe dig med at beslutte, om du skal holde op med at amme eller holde op med at bruge Kyntheum.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity (including safety pharmacology endpoints and assessment of fertility-related endpoints), and toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser (herunder sikkerhedsfarmakologiske endepunkter og vurdering af fertilitetsrelaterede endepunkter) samt reproduktions- og udviklingstoksicitet.
English: Suicidal ideation and behaviour, including completed suicide, have been reported in patients treated with Kyntheum.
Danish: Selvmordstanker og -adfærd, herunder fuldført selvmord, er blevet rapporteret hos patienter behandlet med Kyntheum.
English: If a patient develops a serious infection, the patient should be closely monitored and Kyntheum should not be administered until the infection resolves.
Danish: Hvis en patient udvikler en alvorlig infektion, skal patienten monitoreres tæt, og Kyntheum må ikke administreres, før infektionen er ophørt.
English: Pinch the skin firmly between your thumb and fingers, creating an area about 5 centimetres wide.
Danish: Knib huden fast sammen mellem din tommelfinger og de andre fingre, så der dannes et område, som er ca. 5 cm bredt.
English: If patients develop active Crohn's disease, treatment should be discontinued permanently.
Danish: Hvis patienterne udvikler aktiv Crohns sygdom, skal behandlingen seponeres permanent.
English: Tell your doctor if you think your signs and symptoms of psoriasis are not improving after using Kyntheum.
Danish: Fortæl det til lægen, hvis du synes, at dine psoriasis tegn og symptomer ikke mindskes efter brug af Kyntheum.
English: Vaccination of infants
Danish: Vaccination af spædbørn
English: Possible serious infections (may affect up to 1 in 100 people), the signs may include:
Danish: Mulige alvorlige infektioner (kan forekomme hos op til 1 ud af 100 personer); tegnene kan omfatte:
English: No dose recommendations can be made.
Danish: Der kan ikke gives nogen anbefalinger vedrørende dosering.
English: The safety and efficacy of Kyntheum in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Danish: Sikkerhed og virkning af Kyntheum i kombination med immunosuppressiver, herunder biologiske, eller lysbehandling er ikke blevet evalueret.
English: Pharmacotherapeutic group: Immunosuppressants, Interleukin inhibitors, ATC code: L04AC12
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, interleukinhæmmere, ATC-kode: L04AC12
English: • any part appears cracked or broken.
Danish: • nogen af delene har revner eller er i stykker.
English: • alcohol wipes
Danish: • alkoholservietter
English: See the detailed “Instructions for Use” that comes with this medicine for information on the right way to store, prepare, and give your injections at home.
Danish: Se den detaljerede "Brugervejledning", som følger med dette lægemiddel, for at få oplysninger om, hvordan du opbevarer, klargør og tager dine injektioner hjemme.
English: How much Kyntheum is given
Danish: Hvor meget Kyntheum gives der
English: No data are available on the response to live vaccines or the risk of infection, or transmission of infection after the administration of live vaccines in patients receiving Kyntheum.
Danish: Der foreligger ingen data om respons på levende vacciner eller risikoen for infektion eller overførsel af infektion efter indgivelsen af levende vacciner hos patienter, der får Kyntheum.
English: Table 1: List of adverse reactions in clinical trials System Organ Class
Danish: Tabel 1: Liste over bivirkninger i kliniske forsøg Systemorganklasse
English: Carcinogenicity studies with brodalumab have not been conducted.
Danish: Der er ikke udført karcinogenicitetsstudier med brodalumab.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: The ‘Instructions for Use' should be consulted for detailed instructions on administration of Kyntheum.
Danish: Se "Brugervejledning" for detaljerede instruktioner om administration af Kyntheum.
English: Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Danish: Patienter med initial partiel respons kan i visse tilfælde efterfølgede opnå bedring ved fortsat behandling ud over 16 uger.
English: You may be treated with another medicine for TB before you begin treatment with Kyntheum
Danish: Du skal måske behandles med et andet lægemiddel for TB, før du begynder behandlingen med Kyntheum
English: G. Hold the pinched skin.
Danish: G. Hold fast i den sammenknebne hud.
English: Your doctor, pharmacist or nurse will tell you how often to inject the medicine.
Danish: Lægen, apotekspersonalet eller sygeplejersken vil fortælle dig, hvor tit du skal injicere lægemidlet.
English: Then, talk to your doctor about when you should inject the next dose.
Danish: Herefter skal du spørge din læge, hvornår du skal injicere den efterfølgende dosis.
English: Doses up to 700 mg intravenously have been administered in clinical trials with no evidence of dose limiting toxicity.
Danish: Doser på op til 700 mg er blevet administreret intravenøst i kliniske forsøg uden evidens for dosisbegrænsende toksicitet.
English: • Do not use the syringe if:
Danish: • Brug ikke injektionssprøjten, hvis:
English: The recommended dose is 210 mg (one injection).
Danish: Den anbefalede dosis er 210 mg (én injektion).
English: Important: When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received a full dose.
Danish: Vigtigt: Hvis det ser ud, som om der stadig er medicin i sprøjtecylinderen, når du fjerner injektionssprøjten, betyder det, at du ikke har fået den fulde dosis.
English: Kyntheum should be visually inspected for particles and discoloration prior to administration.
Danish: Kyntheum skal kontrolleres visuelt for partikler og misfarvning inden administration.
English: IL-17RA is a protein expressed on the cell surface and is a required component of receptor complexes utilized by multiple IL-17 family cytokines.
Danish: IL-17RA er et protein, der er udtrykt på celleoverfladen, og er en nødvendig komponent i de receptorkomplekser, som anvendes af en lang række cytokiner i IL-17-familien.
English: If you use more of this medicine than prescribed or take the dose sooner than required, tell your doctor.
Danish: Hvis du har brugt for meget af dette lægemiddel eller har fået din dosis tidligere end nødvendigt, skal du fortælle det til din læge.
English: Most adverse reactions of Kyntheum-associated neutropenia observed were mild, transient and reversible.
Danish: De fleste af de observerede neutropeni-bivirkninger, associeret med Kyntheum, var lette, forbigående og reversible.
English: • Do not touch this area again before injecting.
Danish: • Rør ikke ved dette område igen inden injektionen.
English: However, brodalumab concentrations below LLOQ (Lower Limit of Quantification) were associated with IL-17 receptor occupancy up to 81%.
Danish: Brodalumab-koncentrationer under LLOQ (nedre kvantificeringsgrænse) var dog forbundet med en IL-17-receptorbinding på op til 81 %.
English: n-completed Week 52
Danish: Ikke relevant n-fuldført uge 52
English: K. Check the injection site
Danish: K. Kontrollér injektionsstedet
English: • if you have recently received or are scheduled to receive a vaccination.
Danish: • hvis du er blevet vaccineret for nylig, eller hvis det er planlagt, at du skal vaccineres.
English: Baseline static Physician Global Assessment (sPGA) score ranged from “3 (moderate)” (58%) to “5 (very severe)”
Danish: sPGA-score (static Physician Global Assessment) ved baseline gik fra "3 (moderat)" (58 %) til "5 (meget svær)" (5 %).
English: • if you have been told by your doctor that you have developed Crohn's disease
Danish: • hvis du har fået at vide af lægen, at du har udviklet Crohns sygdom
English: A causal association between treatment with Kyntheum and increased risk of suicidal ideation and behaviour has not been established.
Danish: Der er ikke fastlagt en årsagssammenhæng mellem behandling med Kyntheum og øget risiko for selvmordstanker og -adfærd.
English: • Do not freeze.
Danish: • Må ikke nedfryses.
English: No evidence of altered pharmacokinetic profile, clinical response, or safety profile was associated with anti-brodalumab antibody development.
Danish: Ingen evidens for en ændret farmakokinetisk profil, klinisk respons eller sikkerhedsprofil blev associeret med udviklingen af anti-brodalumab-antistoffer.
English: Rescue treatment was available at or after Week 16 for patients with an inadequate response single sPGA ≥3 or persistent sPGA of 2 over at least a 4-week period.
Danish: Nødbehandling var tilgængelig ved eller efter uge 16 for patienter med utilstrækkelig respons i form af en enkelt sPGA ≥3 eller en vedvarende sPGA på 2 i løbet af en periode på mindst 4 uger.
English: This medicine works by blocking the activity of IL-17 proteins, which are present at increased levels in diseases such as psoriasis.
Danish: Dette lægemiddel virker ved at modvirke aktiviteten af IL-17-proteiner, der findes i øgede mængder ved sygdomme som psoriasis.
English: Elderly (aged 65 years and over) No dose adjustment is recommended in elderly patients (see section 5.2).
Danish: Ældre (65 år og derover) Dosisjustering anbefales ikke hos ældre patienter (se pkt.
English: • mouth or throat pain
Danish: • ondt i munden eller halsen
English: Brodalumab is a monoclonal antibody and is expected to be present in the first milk and at low levels afterwards.
Danish: Brodalumab er et monoklonalt antistof og forventes at være til stede i den første mælk og i lave niveauer herefter.
English: • low white blood cell count
Danish: • lavt antal hvide blodlegemer
English: AMAGINE-2 and AMAGINE-3 were also active comparator (ustekinumab)-controlled.
Danish: AMAGINE-2 og AMAGINE-3 var også aktiv komparator (ustekinumab)-kontrolleret.
English: Approximately 30% of patients had previously received a biological and 12% of patients were biological failures.
Danish: Ca. 30 % af patienterne havde tidligere fået et biologisk lægemiddel, og 12 % af patienterne havde ikke responderet på biologisk behandling.
English: Patients should be instructed to inject the full amount of Kyntheum according to the instructions provided in the package leaflet.
Danish: Patienterne skal instrueres i at injicere den fulde mængde Kyntheum i henhold til instruktionerne i indlægssedlen.