FrancophonIA/ELRC3.0 huggingface dataset:
English: By blocking these proteins, Enpaxiq is expected to slow down the production of immature blood cells and thereby help reduce the symptoms of the disease.
Danish: Ved at blokere disse proteiner forventes Enpaxiq at bremse dannelsen af umodne blodceller og derved medvirke til at nedsætte symptomerne på sygdommen.
English: The study compared Enpaxiq with ‘best available therapy', which included treatments that do not act on JAK proteins such as hydroxyurea or supportive care.
Danish: I undersøgelsen blev Enpaxiq sammenlignet med "bedste tilgængelige behandling", som bestod i behandlinger, der ikke virker på JAK-proteiner, såsom hydroxyurea eller støttende behandling.
English: The active substance in Enpaxiq, pacritinib, blocks the action of JAK2 and FLT3, two proteins involved in the production and growth of blood cells.
Danish: Det aktive stof i Enpaxiq, pacritinib, blokerer virkningen af de to proteiner JAK2 og FLT3, der medvirker ved blodcellernes dannelse og vækst.
English: Enpaxiq was expected to be used to treat patients with an enlarged spleen or other symptoms of myelofibrosis - a disorder in which scar tissue builds up in the bone marrow where blood cells are produced.
Danish: Enpaxiq forventedes anvendt til behandling af patienter med forstørret milt eller andre symptomer på myelofibrose - en sygdom, hvor der ophobes arvæv i knoglemarven, hvor blodcellerne dannes.
English: What is Enpaxiq?
Danish: Hvad er Enpaxiq?
English: The company said that it intends to integrate the new data from the study into its current dossier before approaching EMA to discuss a new application.
Danish: Virksomheden bemærkede, at den vil integrere de nye data fra undersøgelsen i sin nuværende dokumentation, før den kontakter EMA for at drøfte en ny ansøgning Brevet om tilbagetrækningen kan ses her.
English: Enpaxiq was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 25 August 2010 for different types of myelofibrosis.
Danish: Enpaxiq blev udpeget som "lægemiddel til sjældne sygdomme" den 25. august 2010 mod forskellige former for myelofibrose.
English: At the time of the withdrawal of application, the CHMP was of the provisional opinion that Enpaxiq could not have been approved for myelofibrosis.
Danish: CHMP var på tidspunktet for tilbagetrækningen af den foreløbige opfattelse, at Enpaxiq ikke kunne være blevet godkendt mod myelofibrose.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Enpaxiq.
Danish: Virksomheden har til CHMP oplyst, at der ikke er nogen konsekvenser for patienter, som i øjeblikket deltager i kliniske undersøgelser med Enpaxiq eller i programmer for anvendelse af Enpaxiq med særlig udleveringstilladelse.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Enpaxiq eller i programmer for anvendelse af Enpaxiq med særlig udleveringstilladelse?
English: How does Enpaxiq work?
Danish: Hvordan virker Enpaxiq?
English: Mulpleo received a marketing authorisation valid throughout the EU on 18 February 2019.
Danish: Mulpleo fik en markedsføringstilladelse med gyldighed i hele EU den 18. februar 2019.
English: Further information on Mulpleo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/mulpleo.
Danish: Yderligere information om Mulpleo findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/mulpleo.
English: Other information about Mulpleo
Danish: Andre oplysninger om Mulpleo
English: As for all medicines, data on the use of Mulpleo are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Mulpleo løbende overvåget.
English: Treatment with Mulpleo should start at least 8 days before the procedure and the recommended dose is 1 tablet daily for 7 days.
Danish: Behandling med Mulpleo bør starte mindst 8 dage før indgrebet, og den anbefalede dosis er 1 tablet dagligt i 7 dage.
English: Similar effects occurred in patients receiving placebo.
Danish: Lignende virkninger sås hos patienter, der fik placebo.
English: What measures are being taken to ensure the safe and effective use of Mulpleo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Mulpleo?
English: The European Medicines Agency decided that Mulpleo's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Mulpleo opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: An overview of Mulpleo and why it is authorised in the EU
Danish: En oversigt over Mulpleo, og hvorfor det er godkendt i EU
English: What is Mulpleo and what is it used for?
Danish: Hvad er Mulpleo, og hvad anvendes det til?
English: Why is Mulpleo authorised in the EU?
Danish: Hvorfor er Mulpleo godkendt i EU?
English: For more information about using Mulpleo, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Mulpleo, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: 1 Previously known as Lusutrombopag Shionogi.
Danish: 1 Tidligere kaldet Lusutrombopag Shionogi.
English: Mulpleo is available as 3 mg tablets.
Danish: Mulpleo leveres som 3-mg-tabletter.
English: Side effects reported with Mulpleo are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Mulpleo vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Mulpleo contains the active substance lusutrombopag.
Danish: Mulpleo indeholder det aktive stof lusutrombopag.
English: What are the risks associated with Mulpleo?
Danish: Hvilke risici er der forbundet med Mulpleo?
English: Unwanted effects that occurred in studies are thought to result from patients' medical condition and the nature of the invasive procedure for which Mulpleo was used.
Danish: De uønskede virkninger, der forekom i studierne, menes at skyldes patientens sygdom og karakteren af det invasive indgreb, som Mulpleo anvendes til.
English: Mulpleo is a medicine used to prevent excessive bleeding in adults with thrombocytopenia due to longstanding liver disease.
Danish: Mulpleo er et lægemiddel, der anvendes til at forebygge kraftig blødning hos voksne med trombocytopeni som følge af langvarig leversygdom.
English: Studies have found that Mulpleo increases platelet count, thereby lowering the risk of excessive bleeding during or after an invasive procedure and reducing the need for transfusing platelets.
Danish: Studier har vist, at Mulpleo øger blodpladetallet og dermed sænker risikoen for kraftig blødning under eller efter et invasivt indgreb, og at det reducerer behovet for transfusion af blodplader.
English: The second study involving 215 adults found that 65% of patients who took Mulpleo did not require platelet transfusion before their procedure, compared with 29% of patients who received placebo.
Danish: Det andet studie, hvori 215 voksne deltog, viste, at 65 % af de patienter, der fik Mulpleo, ikke havde behov for transfusion af blodplader før proceduren sammenholdt med 29 % af de patienter, der fik placebo.
English: The active substance in Mulpleo, lusutrombopag, attaches to the same receptors as thrombopoietin, helping to increase the platelet count.
Danish: Det aktive stof i Mulpleo, lusutrombopag, binder sig til de samme receptorer som trombopoietin og bidrager dermed til at øge blodpladetallet.
English: Unwanted effects that occurred in studies involving patients taking Mulpleo were headache, nausea (feeling sick), portal vein thrombosis (a blockage in the blood vessel that carries blood from the intestines to the liver) and rash.
Danish: De uønskede virkninger, der forekom i studier hos patienter, der tog Mulpleo, var hovedpine, kvalme, portalåretrombose (blokering af de blodkar, der fører blodet fra tarmene til leveren) og udslæt.
English: The first study, involving 96 adults, found that 79% of patients who took Mulpleo did not require a transfusion of platelets before their procedure, compared with 13% of patients who received placebo (a dummy treatment).
Danish: Det første studie, hvori 96 voksne deltog, viste, at 79 % af de patienter, der fik Mulpleo, ikke havde behov for transfusion af blodplader før indgrebet, sammenholdt med 13 % af de patienter, der fik placebo (en uvirksom behandling).
English: In two main studies involving adults with low levels of platelets due to long-standing liver disease, Mulpleo increased platelet count before an invasive procedure and reduced the need for transfusions.
Danish: I to hovedstudier hos voksne med lave niveauer af blodplader som følge af langvarig leversygdom øgede Mulpleo blodpladetallet før et invasivt indgreb og reducerede behovet for transfusioner.
English: What benefits of Mulpleo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Mulpleo?
English: Mulpleo1 (lusutrombopag)
Danish: (lusutrombopag)
English: How is Mulpleo used?
Danish: Hvordan anvendes Mulpleo?
English: For more information on the side effects and restrictions of Mulpleo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Mulpleo fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mulpleo have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Mulpleo.
English: How does Mulpleo work?
Danish: Hvordan virker Mulpleo?
English: You do not need to do anything about it.
Danish: Du behøver ikke at gøre noget ved det.
English: This generally takes 30 minutes.
Danish: Dette tager normalt 30 minutter.
English: Common Not known
Danish: Almindelig Ikke kendt
English: Wash your hands well with soap and water.
Danish: Vask hænderne grundigt med sæbe og vand.
English: Let it air dry.
Danish: Lad det lufttørre.
English: This creates a firmer surface.
Danish: Dette skaber en fastere overflade.
English: Date of first authorisation: 8 January 2018
Danish: Dato for første markedsføringstilladelse: 8. januar 2018
English: Not known (the frequency cannot be determined from the available data):
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data):
English: Open the carton.
Danish: Åbn kartonen.
English: Elderly patients (≥65 years old)
Danish: Ældre patienter (≥65 år)
English: Important!
Danish: Vigtigt!
English: Such reactions may happen within hours or days after the injection.
Danish: Sådanne reaktioner kan forekomme inden for timer eller dage efter injektionen.
English: Allergic reactions have occurred in patients receiving this medicine.
Danish: Allergiske reaktioner er forekommet hos patienter, der får denne medicin.
English: Median percent reduction
Danish: Median procentvis reduktion
English: n= number of patients with data at timepoint.
Danish: n = antal patienter med data ved tidspunkt.
English: • through clothing
Danish: • gennem tøj
English: Individual day and night time scores were similar.
Danish: De individuelle scorer for dag og nat var ens.
English: • fever (high temperature)
Danish: • feber (høj temperatur)
English: • it has been frozen
Danish: • den har været frossen
English: It is there to prevent you from touching the needle.
Danish: Den er der for at forhindre dig i at berøre nålen.
English: However, no data are available in patients over 75 years of age.
Danish: Der er imidlertid ingen tilgængelige data for patienter over 75 år.
English: No dedicated animal studies have been conducted.
Danish: Der er ikke udført decideret dyrestudier.
English: There may be a small amount of blood or liquid where you injected.
Danish: Der kan være en lille mængde blod eller væske, hvor du injicerede.
English: Total duration of treatment: 104 - 112 weeks
Danish: Samlet behandlingstid: 104-112 uger
English: Keep pushing until it is down as far as it will go.
Danish: Bliv ved med at trykke, indtil det er så langt nede, som det kan komme.
English: You will hear a click.
Danish: Du vil høre et klik.
English: Long-term safety
Danish: Langsigtet sikkerhed
English: Most antibodies were neutralising and persistent.
Danish: De fleste antistoffer var neutraliserende og vedvarende.
English: Do not try to inject yourself in the arm.
Danish: Forsøg ikke at injicere dig selv i armen.
English: Results shown based on last available data for each variable.
Danish: De viste resultater er baseret på de sidst tilgængelige data for hver variabel.
English: This should be done gradually, under the direct supervision of your doctor.
Danish: Dette skal ske gradvist under direkte overvågning af din læge.
English: This is to make sure you inject all of the medication.
Danish: Dette er for at sikre, at du injicerer alt medicinen.
English: Gender, Race
Danish: Køn og race
English: You may also use the lower part of your abdomen.
Danish: Du kan også bruge den nederste del af din mave.
English: These reactions may occur within hours of administration, but in some instances have a delayed onset (i.e. days).
Danish: Disse reaktioner kan opstå inden for timer efter administrationen, men i nogle tilfælde indsætter de senere (dvs. efter nogle dage).
English: It may contain particles.
Danish: Den kan indeholde partikler.
English: It is important that you talk to your doctor about how to recognise early symptoms of serious allergic reactions and how to manage these reactions if they occur.
Danish: Det er vigtigt, at du snakker med din læge om, hvordan du genkender tidlige symptomer på alvorlige allergiske reaktioner, og hvordan du håndterer disse reaktioner, hvis de opstår.
English: For each injection, choose a different site that is at least 3 cm away from where you last injected.
Danish: For hver injektion skal du vælge et nyt sted, der er mindst 3 cm væk fra hvor du sidst fik injektion.
English: If the green plunger does not fill the viewing window, you may not have received the full dose.
Danish: Hvis det grønne stempel ikke udfylder vinduet, har du muligvis ikke fået den fulde dosis.
English: For example, do not warm it in a microwave or hot water, or put it near other heat sources.
Danish: Varm den for eksempel ikke i en mikrobølgeovn eller i varmt vand, og læg den ikke tæt på andre varmekilder.
English: Table 5 summarizes the study results for Trial 3.
Danish: Tabel 5 sammenfatter studieresultaterne fra Studie 3.
English: It may contain small white particles.
Danish: Den kan indeholde små hvide partikler.
English: Week(s)
Danish: Uge(r)
English: Its administration 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 til gravide kvinder bør kun overvejes, hvis den forventede fordel for moderen er større end en eventuel risiko for fostret.
English: The results summarised below are those for the recommended dosing regimen.
Danish: De opsummerede resultater nedenfor gælder for det anbefalede doseringsregime.
English: Number of patients (n) varies slightly due to the number of patients for whom data were available for each variable.
Danish: Antal patienter (n) varierer en smule på grund af antallet af patienter med tilgængelige data for hver variabel.
English: You will hear a second ‘click'.
Danish: Du hører et andet "klik".
English: This medicine may weaken your ability to fight certain types of parasitic infections,
Danish: Dette lægemiddel kan svække din evne til at bekæmpe visse typer parasitinfektioner.
English: Risk to the breast-fed child cannot be excluded.
Danish: En risiko for det ammede barn kan ikke udelukkes.
English: d. EOT for Trial 4 was Week 48 (the last timepoint for adults and adolescent data).
Danish: d. EOT for studie 4 var uge 48 (sidste tidspunkt for data for voksne og unge).
English: Nijmegen, 6545CG Netherlands
Danish: Nijmegen, 6545CG Holland
English: Efficacy and safety were consistent with the predecessor trials.
Danish: Effekt og sikkerhed var i overensstemmelse med de tidligere studier.
English: If your response to the treatment allows it, your doctor may try to reduce the dose of some of these medicines, especially ones called ‘corticosteroids'.
Danish: Hvis din reaktion på behandlingen tillader det, kan lægen forsøge at reducere dosis af nogle af disse lægemidler, især dem, der kaldes ”kortikosteroider”.
English: The most commonly reported adverse reactions during treatment are headache (8%) and pharyngitis (3%).
Danish: De mest almindeligt rapporterede bivirkninger under behandlingen er hovedpine (8 %) og pharyngitis (3 %).
English: If an injection is missed on the planned date, dosing should resume as soon as possible on the indicated regimen; a double dose must not be administered.
Danish: Hvis en injektion glemmes på den planlagte dato, skal doseringen genoptages hurtigst muligt i det angivne regime; der må ikke indgives en dobbeltdosis.
English: Make sure you can see the viewing window.
Danish: Sørg for, at du kan se vinduet.
English: Press down firmly.
Danish: Pres fast ned.
English: Hold down firmly for 15 seconds.
Danish: Tryk fast nedad i 15 sekunder.
English: • the security seal on the carton has been broken
Danish: • forseglingen på kartonen er brudt
English: Difference
Danish: Forskel
English: Seek medical attention immediately if you think you may be having an allergic reaction.
Danish: Søg straks lægehjælp, hvis du tror, at du har fået en allergisk reaktion.
English: • if your asthma remains uncontrolled or worsens during treatment with this medicine.
Danish: • hvis din astma forbliver ukontrolleret eller forværres under behandling med dette lægemiddel.
English: • it has been dropped or damaged
Danish: • den har været tabt eller er ødelagt
English: Follow your healthcare provider's instructions on how to inject.
Danish: Følg sundhedspersonalets anvisninger om, hvordan du injicerer.
English: It is not known whether Fasenra could harm your unborn baby.
Danish: Det er ukendt, om Fasenra kan skade dit ufødte barn.
English: There are no fertility data in humans.
Danish: Der findes ingen data om fertilitet hos mennesker.
English: Serious allergic reactions
Danish: Alvorlige allergiske reaktioner
English: No data are available for children aged 6 to 11 years old.
Danish: Der foreligger ingen data for børn i alderen 6-11 år.
English: b. Integrated analysis of Trial 1 and 2 baseline includes adults and adolescents.
Danish: b. Integreret analyse af studie 1 og 2 baseline inkluderer voksne og unge.
English: If the healthcare professional or caregiver administers the injection, the upper arm can also be used.
Danish: Hvis sundhedspersonalet eller en omsorgsperson administrerer injektionen, kan overarmen også anvendes.
English: Do not use if the expiry date has passed.
Danish: Du må ikke bruge den, hvis udløbsdatoen er overskredet.
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Danish: Hvis der gives en overdosis, skal patienten behandles understøttende med passende monitoring efter behov.
English: Gently hold pressure over your skin with a cotton ball or gauze until the bleeding stops.
Danish: Pres forsigtigt på din hud med en bomuldstot eller gaze, indtil blødningen stopper.
English: Children and adolescents The safety and benefits of this medicine are not known in children below the age of 18.
Danish: Børn og unge Sikkerhed og virkning af denne medicin er ikke kendt hos børn og unge under 18 år.
English: Do not use Fasenra if you are pregnant unless your doctor tells you otherwise.
Danish: Brug ikke Fasenra, hvis du er gravid, medmindre din læge siger andet.
English: The second click tells you the injection has finished.
Danish: Det andet klik fortæller dig, at injektionen er færdig.
English: Reduction in corticosteroid doses, if appropriate, should be gradual and performed under the supervision of a physician.
Danish: Reduktion af doser af kortikosteroider skal, hvis hensigtmæssigt, ske gradvist og foregå under opsyn af en læge.
English: Animal toxicology and/or pharmacology
Danish: Dyretoksikologi og/eller farmakologi
English: The frequency, type and severity of adverse reactions in the adolescent population were observed to be similar to those seen in adults.
Danish: Det blev observeret, at frekvens, type og sværhedsgrad af bivirkningerne i den unge population var den samme som blev set hos voksne.
English: • if you have a parasitic infection or if you live in an area where parasitic infections are common or you are travelling to such a region.
Danish: • hvis du har en parasitinfektion eller hvis du bor i et område, hvor parasitinfektioner er almindelige, eller hvis du rejser til en sådan region.
English: Go straight on to the next steps, without delay.
Danish: Gå straks videre til de næste trin uden ophold.
English: Exacerbations over an extended treatment period
Danish: Eksacerbationer over en forlænget behandlingsperiode
English: The first 3 injections are every 4 weeks.
Danish: De første 3 injektioner gives hver 4. uge.
English: A ‘click' tells you the injection has started.
Danish: Et "klik" fortæller dig, at injektionen er startet.
English: In line with clinical practice, patients should be monitored for an appropriate time after administration of Fasenra.
Danish: I overensstemmelse med klinisk praksis skal patienterne overvåges i en passende tid efter administration af Fasenra.
English: By attaching to the eosinophils, Fasenra helps to reduce their numbers.
Danish: Ved at binde sig til de eosinofile celler hjælper Fasenra med at reducere deres antal.
English: There is a limited amount of data (less than 300 pregnancy outcomes) from the use of benralizumab in pregnant women.
Danish: Der er utilstrækkelige data (mindre end 300 graviditeter) fra anvendelse af benralizumab til gravide kvinder.
English: MedImmune UK Ltd 6 Renaissance Way Liverpool, L24 9JW United Kingdom
Danish: MedImmune UK Ltd 6 Renaissance Way Liverpool, L24 9JW Storbritannien
English: Following subcutaneous administration, the elimination half-life was approximately 15.5 days.
Danish: Efter subkutan administration var eliminationshalveringstiden ca. 15,5 dage.
English: Common (these may affect up to 1 in 10 people)
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 personer)
English: There is no evidence of IL-5Rα expression on hepatocytes.
Danish: Der findes intet bevis for ekspression af IL-5Rα på hepatocytter.
English: Other medicines for asthma
Danish: Brug af anden medicin mod astma
English: Parasitic (Helminth) Infection
Danish: Parasitinfektion (Helminth-infektion)
English: Patients were permitted to enter a second extension trial after a minimum of 8 weeks in Trial 4 without completing the 56-week extension period.
Danish: Patienterne fik lov til at fortsætte i et andet forlængelsesstudie efter mindst 8 uger i studie 4 uden at fuldføre den 56 ugers forlængelsesperiode.
English: Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment.
Danish: Patienterne skal instrueres i at søge lægehjælp, hvis deres astma forbliver ukontrolleret eller forværres efter initiering af behandlingen.
English: Hypersensitivity reactions** Anaphylactic reaction
Danish: Overfølsomhedsreaktioner** Anafylaktisk reaktion
English: If needed, cover the injection site with a small bandage.
Danish: Om nødvendigt kan du dække injektionsstedet med et lille plaster.