FrancophonIA/ELRC3.0 huggingface dataset:
English: Beromun treatment should only be carried out in special centres by surgical teams who have experience in the treatment of this type of cancer and ILP.
Danish: Behandling med Beromun bør kun udføres på en specialafdeling af et operationshold med erfaring i behandling af denne kræfttype og i anvendelse af ILP.
English: The independent reviewers agreed that 62% of the patients receiving Beromun and melphalan (90 out of 145) had a better outcome than predicted, since their limb was saved without surgery to remove the tumour or their tumour was removed without causing significant loss of function.
Danish: De uafhængige bedømmere var enige om, at 62 % af de patienter (90 af 145), der fik Beromun og melfalan, fik et bedre udfald end ventet, idet deres arm eller ben blev reddet, uden at de behøvede at blive opereret for at få fjernet svulsten, eller svulsten blev fjernet uden væsentligt funktionstab.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Beromun's benefits are greater than its risks as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic ILP.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at fordelene ved Beromun opvejer risiciene som tillægsbehandling til operation med henblik på at forhindre eller forsinke amputation ved efterfølgende fjernelse af svulsten, samt til symptomlindrende behandling af ikke opererbart bløddelssarkom i lemmerne, anvendt i kombination med melfalan via let hypertermisk ILP.
English: Other side effects seen very commonly (in more than 1 patient in 10) are infection, cardiac arrhythmia (unstable heartbeat), nausea (feeling sick), vomiting, liver damage, fatigue (tiredness), chills, pain in the limb, nerve injury, skin reactions, oedema (swelling) and wound infection.
Danish: Andre bivirkninger, der er meget almindelige (hos flere end 1 ud af hver 10 patienter), er infektion, uregelmæssig hjerterytme, kvalme, opkastning, beskadigelse af leveren, træthed, kulderystelser, smerte i det pågældende lem, nervelæsioner, hudreaktioner, hævelse og sårinfektion.
English: Beromun should not be used in people who may be hypersensitive (allergic) to tasonermin or any of the other ingredients.
Danish: Beromun bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for tasonermin eller andre af indholdsstofferne.
English: It must not be used in patients with significant cardiovascular (heart and blood vessel) disease, severe lung disease, a recent or active stomach ulcer, severe ascites (fluid accumulation in the abdomen), blood disorders, kidney or liver disease, or hypercalcaemia (high blood calcium levels), or in women who are pregnant or breast-feeding.
Danish: Det må ikke anvendes hos patienter med hjertekarsygdomme af væsentligt omfang, svære lungesygdomme, nyligt eller aktivt mavesår, svær væskeansamling i bughulen, blodsygdomme, nyre- eller leversygdom eller for højt kalciumindhold i blodet, eller hos kvinder, der er gravide eller ammer.
English: The centres must also have intensive care units readily available and facilities to continuously look out for leakage of the medicine into the rest of the body using radioactive tracers.
Danish: Behandlingsstedet skal desuden råde over en intensivafdeling og udstyr, som ved hjælp af radioaktive sporstoffer gør det muligt løbende at kontrollere, om der sker udsivning af lægemidlet til resten af kroppen.
English: Before Beromun is given, the limb is first isolated: while the patient is under general anaesthetic, a tight band is placed around the top of the limb to isolate its blood supply and prevent the medicine reaching the rest of the body.
Danish: Før Beromun gives, isoleres det pågældende lem: Under fuld bedøvelse lægges der en stram bandage om øverste del af lemmet, så dets blodforsyning afbrydes og medicinen forhindres i at sprede sig til resten af kroppen.
English: For a more complete list of the side effects reported with Beromun, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Beromun fremgår af indlægssedlen.
English: What is Beromun?
Danish: Hvad er Beromun?
English: Beromun is then injected into the perfusion solution at a dose of 3 mg for an arm and 4 mg for a leg, given over 90 minutes.
Danish: Derefter indsprøjtes Beromun gennem perfusionsvæsken i en dosis af 3 mg til en arm og 4 mg til et ben.
English: What benefit has Beromun shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved Beromun?
English: What is Beromun used for?
Danish: Hvad anvendes Beromun til?
English: Beromun is a powder and solvent that are made up into a solution for infusion.
Danish: Beromun består af et pulver og en opløsning, der blandes til en injektionsvæske (opløsning).
English: How has Beromun been studied?
Danish: Hvordan blev Beromun undersøgt?
English: How is Beromun used?
Danish: Hvordan anvendes Beromun?
English: Beromun is used in patients with soft tissue sarcoma (a type of cancer) of the limb (arm or leg), together with melphalan (an anticancer medicine), using a technique called ‘isolated limb perfusion' (ILP): both medicines are injected into the limb while the blood circulation in the limb is kept isolated (cut off) from the rest of the body.
Danish: Det anvendes i kombination med melfalan (et kræftmiddel) med brug af en teknik, der kaldes isoleret ekstremitetsperfusion (ILP): De to lægemidler indsprøjtes i det pågældende lem.
English: See the Summary of Product Characteristics (also part of the EPAR) for the full list of restrictions.
Danish: En fuldstændig liste over begrænsningerne for anvendelsen fremgår af produktresuméet, der ligeledes er en del af EPAR.
English: The blood circulation in the limb is then replaced by the ‘perfusion' of a special liquid and the limb is warmed to a temperature of between 38 and 39°C.
Danish: Blodgennemstrømningen i lemmet erstattes derefter med perfusion (gennemskylning) med en særlig væske.
English: The dose of melphalan depends on the size of the arm or leg. At the end of the 90-minute procedure, the medicines are flushed out of the limb using a suitable fluid.
Danish: Når de 90 minutter er gået, skylles medicinen ud af lemmet med en passende væske.
English: How does Beromun work?
Danish: Hvordan virker Beromun?
English: 1 vial + 1 syringe
Danish: 1 hætteglas + 1 sprøjte
English: 2 vials + 2 syringes
Danish: 2 hætteglas sprøjter
English: What is Besponsa and what is it used for?
Danish: Hvad er Besponsa, og hvad anvendes det til?
English: The infusions are given on days 1, 8 and 15 of a 3 or 4 week treatment cycle.
Danish: Infusionerne gives på dag 1, 8 og 15 i et 3- eller 4-ugers behandlingsforløb.
English: This is a summary of the European public assessment report (EPAR) for Besponsa.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Besponsa.
English: What measures are being taken to ensure the safe and effective use of Besponsa?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Besponsa?
English: It is not intended to provide practical advice on how to use Besponsa.
Danish: Det er ikke en praktisk vejledning i, hvordan Besponsa bør anvendes.
English: An analysis of the first 218 patients treated showed that after at least 2 cycles of treatment, 81% (88 out of 109) of patients receiving Besponsa responded to treatment compared with 29% (32 out of 109) of patients receiving other chemotherapy.
Danish: En analyse af de første 218 behandlede patienter viste, at behandlingen efter mindst 2 behandlingsforløb virkede hos 81 % (88 ud af 109) af dem, der fik Besponsa, sammenholdt med 29 % (32 ud af 109) af dem, der fik anden kemoterapi.
English: This means that patients' have a particular protein (CD22) on the surface of their white blood cells.
Danish: Det betyder, at patienterne har et særligt protein (CD22) på overfladen af de hvide blodlegemer.
English: Besponsa is given as an infusion (drip) into a vein lasting for at least one hour.
Danish: Besponsa gives med drop (som infusion) i en vene over mindst én time.
English: Besponsa must not be used in patients who have VOD/SOS or have had severe VOD/SOS or have other serious liver diseases.
Danish: Besponsa må ikke anvendes til patienter, der har VOD/SOS, har haft svær VOD/SOS eller har andre alvorlige leversygdomme.
English: Why is Besponsa approved?
Danish: Hvorfor blev Besponsa godkendt?
English: Because the number of patients with B-cell precursor ALL is low, the disease is considered ‘rare', and Besponsa was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 June 2013.
Danish: Da antallet af patienter med precursor B-celle ALL er lavt, betragtes sygdommen som "sjælden", og Besponsa blev udpeget som "lægemiddel til sjældne sygdomme" den 7. juni 2013.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Besponsa's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Besponsa opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The full EPAR for Besponsa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Besponsa findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Besponsa can only be obtained with a prescription, and treatment should be given under the supervision of a doctor who has experience in the use of cancer treatments.
Danish: Besponsa udleveres kun efter recept, og behandlingen bør gives under opsyn af en læge med erfaring i kræftbehandling.
English: The CHMP considered that although there have been recent advances in the treatment of B-cell precursor ALL, treatment options for patients remain limited.
Danish: CHMP tog i betragtning, at uanset de nylige fremskridt i behandlingen af precursor B-celle ALL er behandlingsmulighederne fortsat begrænsede.
English: Besponsa contains the active substance inotuzumab ozogamicin.
Danish: Besponsa indeholder det aktive stof inotuzumab ozogamicin.
English: Other information aboutBesponsa
Danish: Andre oplysninger om Besponsa
English: Besponsa is used on its own in adults whose cancer has come back or did not respond to previous treatment.
Danish: Besponsa anvendes som enebehandling til voksne, hvis kræft er vendt tilbage eller som ikke har reageret på tidligere behandling.
English: What are the risks associated with Besponsa?
Danish: Hvilke risici er der forbundet med Besponsa?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Besponsa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Besponsa findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Besponsa was shown to be more effective than other chemotherapy (medicines to treat cancer) in one main study involving 326 adults with CD22-positive B-cell precursor ALL, which had come back or had not responded to previous treatment.
Danish: Besponsa er påvist at være mere effektivt end anden kemoterapi (kræftmedicin) i en hovedundersøgelse med 326 voksne med CD22-positiv precursor B-celle ALL, som var vendt tilbage, eller som tidligere behandling ikke havde virket på.
English: Besponsa is only used in patients with ‘CD22-positive B-cell precursor ALL'.
Danish: Besponsa anvendes kun hos patienter med "CD22-positiv precursor B-celle ALL".
English: How is Besponsa used?
Danish: Hvordan anvendes Besponsa?
English: For more information about treatment with Besponsa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Besponsa, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Once attached, the medicine is taken up by the cell where calicheamicin becomes active, causing breaks in the cell's DNA and thereby killing the cancer cell.
Danish: Når lægemidlet har bundet sig dertil, optages det i cellen, hvor calicheamicin bliver aktivt, hvilket medfører brud på kræftcellens DNA, så den dør.
English: Patients in whom Besponsa works well should receive 2 or 3 cycles, after which they can have a stem cell transplant to replace their bone marrow, the only curative treatment.
Danish: Patienter, hos hvem Besponsa virker godt, bør have 2 eller 3 behandlingsforløb, hvorefter de kan få en stamcelletransplantation for at erstatte deres knoglemarv, hvilket er den eneste helbredende behandling.
English: With regard to safety, the side effects with Besponsa are similar to those of other chemotherapy medicines and can usually be managed by dose reduction or treatment interruption.
Danish: Hvad sikkerheden angår, svarer bivirkningerne med Besponsa til anden kemoterapi og kan normalt håndteres ved at nedsætte dosis eller stoppe behandlingen.
English: Besponsa is a cancer medicine used to treat a type of blood cancer which affects B cells (a type of white blood cells) called B-cell precursor acute lymphoblastic leukaemia (ALL).
Danish: Besponsa er et kræftlægemiddel, der anvendes til behandling af en form for blodkræft, der udgår fra hvide blodlegemer af typen B-celler og som kaldes precursor B-celle akut lymfoblastær leukæmi (ALL).
English: The main measure of effectiveness was response to treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på behandlingsresponsen.
English: The most common side effects with Besponsa (which may affect more than 1 in 5 people) are thrombocytopenia (low blood platelet counts), neutropenia and leucopenia (low white blood cell counts), infection, anaemia (low red blood cell counts), tiredness, haemorrhage (bleeding), fever, nausea (feeling sick), headache, febrile neutropenia (low white cell count with fever), abdominal pain (stomach ache), increased levels of liver enzymes called transaminases and gammaglutamyltransferase, and hyperbilirubinaemia (high blood levels of bilirubin, a breakdown product of red blood cells).
Danish: De hyppigste bivirkninger ved Besponsa (som kan forekomme hos mere end 1 ud af 5 personer) er lavt antal blodplader (trombocytopeni), lavt antal hvide blodlegemer (neutropeni og leukopeni), infektioner, lavt antal røde blodlegemer (anæmi), træthed, blødning (hæmoragi), feber, kvalme, hovedpine, lavt antal hvide blodlegemer ledsaget af feber (febril neutropeni), mavesmerter, forhøjet koncentration af leverenzymerne transaminaser og gamma-glutamyltransferase, og høj blodkoncentration af bilirubin (et nedbrydningsprodukt af røde blodlegemer).
English: The monoclonal antibody has been designed to recognise and attach to CD22 on the cancerous B cells.
Danish: Det monoklonale antistof er udformet, så det genkender og bindes til CD22 på B-cellerne, der er kræftceller.
English: The most serious side effects are infection, febrile neutropenia, haemorrhage, abdominal pain, fever, tiredness and veno-occlusive liver disease/sinusoidal obstruction syndrome (VOD/SOS, a serious liver disease).
Danish: De alvorligste bivirkninger er infektioner, febril neutropeni, blødning, mavesmerter, feber, træthed og den alvorlige leversygdom veno-okklusiv leversygdom/sinusobstruktionssyndrom (VOD/SOS).
English: The active substance in Besponsa, inotuzumab ozogamicin, is a monoclonal antibody (a type of protein) that has been linked to a small molecule, N-acetyl-gamma-calicheamicin dimethylhydrazide.
Danish: Det aktive stof i Besponsa, inotuzumab ozogamicin, er et protein af typen monoklonalt antistof, der er kædet sammen med det lille molekyle N-acetyl-gamma-calicheamicin-dimethylhydrazid.
English: Patients were considered to have responded if they had no remaining cancerous B cells in their blood and bone marrow after treatment.
Danish: Behandlingen blev anset for at have virket på patienten, hvis denne ikke havde nogen kræft-B-celler tilbage i blodet eller knoglemarven efter behandlingen.
English: What benefits of Besponsa have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Besponsa?
English: The main study showed that Besponsa was better than other commonly used chemotherapy medicines at inducing a response in patients and allowing them to have a curative stem cell transplant.
Danish: Hovedundersøgelsen viste, at Besponsa gav en bedre virkning hos patienterne end anden almindeligt anvendt kemoterapi, og at det gav dem mulighed for at få en helbredende stamcelletransplantation.
English: Patients whose treatment works well, but who are not going to receive a stem cell transplant, may receive up to a maximum of 6 cycles of treatment.
Danish: Patienter, hos hvem behandlingen virker godt, men som ikke skal have stamcelletransplantation, kan højst få 6 behandlingsforløb.
English: In patients who have a type of chromosome known as Philadelphia-chromosome, treatment with a cancer medicine called a tyrosine kinase inhibitor should have been tried before starting Besponsa.
Danish: Patienter med det særlige Philadelphia-kromosom bør have været forsøgt behandlet med et kræftlægemiddel af typen tyrosinkinasehæmmer før behandlingen med Besponsa.
English: For the full list of all side effects and restrictions reported with Besponsa, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Besponsa fremgår af indlægssedlen.
English: For practical information about using Besponsa, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Besponsa, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Patients who responded to treatment could proceed to have a stem cell transplant.
Danish: Patienter, hos hvem behandlingen virkede, kunne få en stamcelletransplantation.
English: In patients who do not respond to treatment, Besponsa should be stopped after 3 cycles.
Danish: Hvis behandlingen med Besponsa ikke virker, bør den stoppes efter 3 behandlingsforløb.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Besponsa have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er anført anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Besponsa.
English: The doctor may interrupt treatment or reduce the dose, if the patient develops certain serious side effects.
Danish: Hvis patienten får visse alvorlige bivirkninger, kan lægen nedsætte dosis eller helt standse behandlingen.
English: How does Besponsa work?
Danish: Hvordan virker Besponsa?
English: 3 bottles
Danish: 3 flasker
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Danish: EU- nummer Særnavn Styrke Lægemiddelform Indgivelsesvej
English: Package size
Danish: Indhold Pakningsstørrelser
English: This summary was last updated in November 2012.
Danish: Dette sammendrag blev sidst ajourført i november 2012.
English: This medicine is the same as Axura, which is already authorised in the European Union (EU).
Danish: Dette lægemiddel er identisk med Axura, som allerede er godkendt i Den Europæiske Union (EU).
English: It is available as tablets (5 mg, 10 mg, 15 mg and 20 mg).
Danish: Det fås som tabletter (5 mg, 10 mg, 15 mg og 20 mg).
English: If the solution is used, the dose should first be pumped onto a spoon or into a glass of water.
Danish: Hvis opløsningen anvendes, skal dosis først pumpes ud på en ske eller ned i et glas vand.
English: Memantine Merz should be given once a day, at the same time every day.
Danish: Memantine Merz bør gives en gang dagligt på samme tidspunkt hver dag.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Memantine Merz on 22 November 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Memantine Merz den 22. november 2012.
English: The full EPAR for Memantine Merz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Memantine Merz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: To prevent side effects, the dose of Memantine Merz is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Danish: For at undgå bivirkninger øges dosis af Memantine Merz gradvist i løbet af de tre første uger af behandlingen: I den første uge er dosis 5 mg, i den anden uge er den 10 mg, og i den tredje uge er den 15 mg. Fra uge fire og fremover er den anbefalede vedligeholdelsesdosis 20 mg en gang dagligt.
English: The first study involved 252 patients with moderately severe to severe disease, while the other two involved a total of 873 patients with mild to moderate disease.
Danish: Den første undersøgelse omfattede 252 patienter med moderat svær til svær sygdom, mens de to andre undersøgelser tilsammen omfattede 873 patienter med let til moderat sygdom.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Memantine Merz.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Memantine Merz.
English: The tolerance and dose should be assessed within 3 months after starting treatment, and from then on the benefits of continuing treatment with Memantine Merz should be re-assessed on a regular basis.
Danish: Tolerance og dosis bør vurderes inden for 3 måneder efter behandlingens start, og herefter bør fordelene ved at fortsætte behandlingen med Memantine Merz regelmæssigt genvurderes.
English: This is a summary of the European public assessment report (EPAR) for Memantine Merz.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Memantine Merz.
English: For more information about treatment with Memantine Merz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Memantine Merz, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The company that makes Axura has agreed that its scientific data can be used for Memantine Merz (‘informed consent').
Danish: Virksomheden, som fremstiller Axura, har indvilget i, at dens videnskabelige oplysninger kan anvendes for Memantine Merz (‘informeret samtykke').
English: Memantine Merz was compared with placebo (a dummy treatment) over 24 to 28 weeks.
Danish: Memantine Merz blev sammenlignet med placebo (uvirksom behandling) over 24 til 28 uger.
English: The most common side effects with Memantine Merz (seen in between 1 and 10 patients in 100) are somnolence (sleepiness), dizziness, balance disorders, hypertension (high blood pressure), dyspnoea (difficulty breathing), constipation, headache, raised liver function test results and drug hypersensitivity (allergy to the medicine).
Danish: De hyppigste bivirkninger ved Memantine Merz (som optræder hos mellem 1 og 10 patienter ud af 100) er somnolens (søvnighed), svimmelhed, for højt blodtryk, dyspnø (vejrtrækningsbesvær), forstoppelse, hovedpine, forhøjede resultater af leverfunktionsprøver og lægemiddeloverfølsomhed (allergi over for lægemidlet).