FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment lasts around 6 months, but not all the medicines are given every month.
Danish: Behandlingen varer ca. seks måneder, men ikke alle lægemidlerne gives hver måned.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Unituxin on 14 August 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Unituxin den 14. august 2015.
English: Unituxin is given on four consecutive days each month, in the first 5 months.
Danish: Unituxin gives i fire på hinanden følgende dage hver måned i de første fem måneder.
English: The daily dose depends on the child's body surface area, and infusions are given over 10 hours.
Danish: Den daglige dosis afhænger af barnets legemsoverflade, og infusionerne gives over 10 timer.
English: This is a summary of the European public assessment report (EPAR) for Unituxin.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Unituxin.
English: The number of patients who have to stop treatment because of side effects appears low and the side effects can be managed with appropriate measures.
Danish: Antallet af patienter, der bliver nødt til at stoppe behandlingen på grund af bivirkninger, synes at være lavt, og bivirkningerne kan håndteres med passende forholdsregler.
English: In addition, the company that markets Unituxin will carry out two studies to get more information about the safety of the medicine, including its long-term safety.
Danish: Desuden vil den virksomhed, der markedsfører Unituxin, gennemføre to undersøgelser for at få yderligere information om lægemidlets sikkerhed, herunder dets langtidssikkerhed.
English: After around 3 years, 80% of patients receiving Unituxin were alive compared with 67% of patients receiving isotretinoin alone.
Danish: Efter ca. tre år var 80 % af de patienter, som fik Unituxin, i live, sammenlignet med 67 % af de patienter, der fik isotretinoin alene.
English: Other information about Unituxin
Danish: Andre oplysninger om Unituxin
English: A risk management plan has been developed to ensure that Unituxin is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Unituxin anvendes så sikkert som muligt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Unituxin'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 Unituxin opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Because the number of patients with neuroblastoma is low, the disease is considered ‘rare', and Unituxin was designated an ‘orphan medicine' (a medicine used in rare diseases) on 21 June 2011.
Danish: Da antallet af patienter med neuroblastom er lavt, betragtes sygdommen som "sjælden", og Unituxin blev udpeget som "lægemiddel til sjældne sygdomme" den 21. juni 2011.
English: The most common side effects with Unituxin (seen in more than 30% of patients) are: pain affecting any part of the body, hypotension (low blood pressure), hypersensitivity (allergic reactions), fever, urticaria (hives), capillary leak syndrome (a condition whereby fluid leaks from the blood vessels causing swelling and a fall in blood pressure), anaemia (low red blood cell counts), low platelet counts, low sodium and potassium levels, raised liver enzymes and low levels of white blood cells.
Danish: De hyppigste bivirkninger ved Unituxin (som optræder hos mere end 30 % af patienterne) er smerter, der påvirker en hvilken som helst kropsdel, hypotension (lavt blodtryk), overfølsomhed (allergiske reaktioner), feber, hududslæt (nældefeber), kapillærlækagesyndrom (en tilstand, hvor væskelækager fra blodkarrene forårsager hævelse og blodtryksfald), anæmi (lavt antal røde blodlegemer), lavt antal blodplader, lave natrium- og kaliumniveauer, forhøjede leverenzymer og lavt niveau af hvide blodlegemer.
English: Unituxin is only for hospital use and treatment should be supervised by a doctor experienced in cancer treatments.
Danish: Unituxin er kun til hospitalsbrug, og behandling bør overvåges af en læge med erfaring i kræftbehandlinger.
English: Patients with high-risk neuroblastoma need aggressive therapy, which is often not sufficient to prevent the cancer from returning.
Danish: Patienter med højrisiko-neuroblastom har behov for en aggressiv behandling, som ofte ikke er tilstrækkelig til at forebygge, at kræften vender tilbage.
English: Although side effects with Unituxin can be severe, and medication is required to prevent allergic reactions and pain, the medicine's risks are considered acceptable given the severity of the disease.
Danish: Selvom bivirkningerne ved Unituxin kan være alvorlige, og medicinering er nødvendig for at forhindre allergiske reaktioner og smerte, anses lægemidlets risici for at være acceptable i betragtning af sygdommens sværhedsgrad.
English: What measures are being taken to ensure the safe and effective use of Unituxin?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Unituxin?
English: What is Unituxin and what is it used for?
Danish: Hvad er Unituxin, og hvad anvendes det til?
English: Children treated with Unituxin will first have responded to chemotherapy and then received an additional treatment to clear out their bone marrow (myeloablative therapy) and a stemcell transplantation.
Danish: Børn, som behandles med Unituxin, vil forinden have responderet på kemoterapi og derefter fået en yderligere behandling for at rense deres knoglemarv (myeloablativ terapi) og en stamcelletransplantation.
English: Unituxin is a cancer medicine used to treat neuroblastoma, a nerve cell cancer, in children aged 12 months to 17 years.
Danish: Unituxin er et kræftlægemiddel, der anvendes til behandling af neuroblastom, en nervecellekræft, hos børn i alderen 12 måneder til 17 år.
English: Unituxin contains the active substance dinutuximab.
Danish: Unituxin indeholder det aktive stof dinutuximab.
English: The full EPAR and risk management plan summary for Unituxin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Unituxin findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A study of Unituxin in combination with isotretinoin, GM-CSF and interleukin-2 showed that the combination can improve outcomes in these patients, keeping them alive for longer and helping to prevent the disease from returning or getting worse.
Danish: En undersøgelse af Unituxin i kombination med isotretinoin, GM-CSF og interleukin-2 viste, at kombinationen kan forbedre resultaterne hos disse patienter ved at holde dem i live i længere tid og hjælpe med at forebygge, at sygdommen vender tilbage eller forværres.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Unituxin, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Unituxin, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Because pain is a common side of Unituxin treatment, patients are also given pain killers.
Danish: Fordi smerte er en almindelig bivirkning ved behandling med Unituxin, får patienterne også smertestillende medicin.
English: Why is Unituxin approved?
Danish: Hvorfor blev Unituxin godkendt?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Unituxin 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 Unituxin findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Because of the risk of severe allergic reactions with Unituxin, equipment and staff should be immediately available to resuscitate the patient if reactions occur.
Danish: På grund af risikoen for alvorlige allergiske reaktioner med Unituxin skal der være umiddelbar adgang til genoplivningsudstyr og personale, som kan genoplive patienten, hvis der forekommer allergiske reaktioner.
English: Unituxin is given as an infusion (drip) into a vein.
Danish: Unituxin gives som infusionsvæske (drop) i en vene.
English: The active substance in Unituxin, dinutuximab, is a monoclonal antibody, designed to recognise and attach to a substance present at high levels in neuroblastoma cancer cells known as ganglioside GD2.
Danish: Det aktive stof i Unituxin, dinutuximab, er et monoklonalt antistof, der er udviklet til at genkende og binde sig til et stof kaldet gangliosid GD2, som er til stede i høje niveauer i neuroblastomkræftceller.
English: It is not intended to provide practical advice on how to use Unituxin.
Danish: Det er ikke en praktisk vejledning i, hvordan Unituxin bør anvendes.
English: For more information about treatment with Unituxin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Unituxin, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: A main study conducted in 230 patients with high-risk neuroblastoma showed that Unituxin (given with isotretinoin, GM-CSF and interleukin-2) was more effective than isotretinoin alone at keeping patients alive and preventing the re-emergence of their cancer.
Danish: En hovedundersøgelse omfattende 230 patienter med højrisiko-neuroblastom viste, at Unituxin (givet sammen med isotretinoin, GM-CSF og interleukin-2) var mere effektivt end isotretinoin alene til at holde patienterne i live og forhindre, at deres kræft vendte tilbage.
English: Unituxin is given in combination with 3 other medicines: GM-CSF, interleukin-2 and isotretinoin.
Danish: Unituxin gives i kombination med følgende tre andre lægemidler: GM-CSF, interleukin-2 og isotretinoin.
English: What are the risks associated with Unituxin?
Danish: Hvilke risici er der forbundet med Unituxin?
English: Unituxin is used to treat children with ‘high-risk' neuroblastoma, the form of the cancer that has a high chance of returning.
Danish: Unituxin anvendes til behandling af børn med højrisiko-neuroblastom, dvs. den form for neuroblastom, som har en høj risiko for at vende tilbage.
English: Patients should also be given an antihistamine medicine before the start of each Unituxin infusion to reduce the risk of a reaction.
Danish: For at reducere risikoen for en reaktion bør patienterne også gives antihistamin, før hver infusion med Unituxin påbegyndes.
English: When dinutuximab attaches to the gangliosides on neuroblastoma cells, it marks the cells out as targets for the immune system (the body's natural defences), which then attacks them.
Danish: Når dinutuximab binder sig til gangliosiderne på neuroblastomceller, markerer det cellerne som mål for immunsystemet (kroppens naturlige forsvar), som så angriber dem. På denne måde kan lægemidlet hjælpe med at fjerne kræftceller, som stadig er tilbage i kroppen efter andre behandlinger.
English: For practical information about using Unituxin, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Unituxin, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Unituxin used?
Danish: Hvordan anvendes Unituxin?
English: What benefits of Unituxin have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Unituxin?
English: How does Unituxin work?
Danish: Hvordan virker Unituxin?
English: The patient also receives 3 other medicines: isotretinoin,
Danish: Patienten får også følgende tre andre lægemidler: isotretinoin, GM-CSF og interleukin-2.
English: This overview was last updated in April 2019.
Danish: Denne oversigt blev sidst ajourført i april 2019.
English: In the future, the immune system will be able to react against the virus more quickly.
Danish: Herefter vil immunsystemet være i stand til at reagere hurtigere på virussen.
English: This will help protect the pig against the disease.
Danish: Dette hjælper med at beskytte svinet mod sygdommen.
English: There may also be disease of the airways which can lead to high death rates in suckling and weaned pigs.
Danish: Der kan ligeledes opstå sygdom i luftvejene, som kan føre til høj dødelighed hos pattegrise og fravænnede svin.
English: Suvaxyn PRRS MLV received a marketing authorisation valid throughout the EU on 24 August 2017.
Danish: Suvaxyn PRRS MLV fik en markedsføringstilladelse med gyldighed i hele EU den 24. august 2017.
English: When a pig is given the vaccine, the pig's immune system recognises the virus as ‘foreign' and makes antibodies against it.
Danish: Når et svin får vaccinen, opfatter svinets immunsystem virussen som "fremmed" og danner antistoffer mod den.
English: Further information on Suvaxyn PRRS MLV can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/suvaxyn-prrs-mlv.
Danish: Yderligere information om Suvaxyn PRRS MLV findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/suvaxyn-prrs-mlv.
English: The withdrawal period for meat from pigs treated with Suvaxyn PRRS MLV is ‘zero' days, which means there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød fra svin, der behandles med Suvaxyn PRRS MLV, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: The most common side effects with Suvaxyn PRRS MLV are a short lived increase in body temperature (0.5-0.8 °C on average), which may affect more than 1 in 10 pigs within 4 days of vaccination, and local reactions in the form of swellings which resolve without treatment in 5 to 9 days.
Danish: De hyppigste bivirkninger ved Suvaxyn PRRS MLV er en forbigående stigning i kropstemperaturen (0,5-0,8 °C i gennemsnit), som kan forekomme hos mere end 1 ud af 10 svin inden for 4 dage efter vaccinationen, og lokale reaktioner i form af hævelser, der er forsvinder uden behandling i løbet af 5-9 dage.
English: This viral disease of pigs may result in lowered farrowing (birth) rates, increase in abortions, stillborn, mummified as well as weak live born piglets and deaths.
Danish: Denne virussygdom hos svin kan resultere i en lavere faringshyppighed (fødselshyppighed) og i en stigning i antallet af aborter, dødfødsler, mumificerede fostre samt svage levendefødte smågrise og dødsfald.
English: Mass vaccination can take place in herds in which presence of European PRRS virus is known.
Danish: Massevaccination kan finde sted i besætninger, hvor tilstedeværelsen af europæisk PRRS-virus er fastslået.
English: In pregnant gilts and sows with no prior exposure to PRRS virus, Suvaxyn PRRS MLV must not be used in the second half of pregnancy because the virus in the vaccine may cross the placenta and affect the birth rate.
Danish: Hos drægtige gylte og søer uden forudgående eksponering for PRRS-virus må Suvaxyn PRRS MLV ikke anvendes i anden halvdel af drægtighedsperioden, fordi virusset i vaccinen kan krydse moderkagen og påvirke fødselsraten.
English: Gilts (female pigs that have not yet had piglets) and sows (female pigs that have had piglets) are given a single injection before introduction into the sow herd, about 4 weeks before breeding, and a booster injection every 6 months.
Danish: Gylte (hungrise, som endnu ikke har fået unger) og søer (hungrise, som har fået unger) får en enkelt injektion, inden de indføres i besætningen af søer ca. 4 uger før avl, og en opfølgende injektion hver 6. måned.
English: Suvaxyn PRRS MLV contains a modified strain of live PRRS virus, strain 96V198, that has been weakened so that it does not cause disease.
Danish: Suvaxyn PRRS MLV indeholder en modificeret stamme af levende PRRS-virus, stamme 96V198, som er blevet svækket, så den ikke forårsager sygdom.
English: The European Medicines Agency decided that Suvaxyn PRRS MLV's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Suvaxyn PRRS MLV opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: For further information about using Suvaxyn PRRS MLV, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Suvaxyn PRRS MLV, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: The second study in sows showed that a booster vaccination 6 months after the initial vaccination, with mating performed 4 months after the second vaccination, gave protection for 7 months.
Danish: Det andet studie hos søer viste, at en opfølgende vaccination 6 måneder efter den indledende vaccination, hvor parringen skete 4 måneder efter den anden vaccination, gav beskyttelse i 7 måneder.
English: Suvaxyn PRRS MLV must not be used in herds where European PRRS virus has not been detected by reliable diagnostic methods.
Danish: Suvaxyn PRRS MLV må ikke anvendes i besætninger, hvor der ikke er påvist europæisk PRRS-virus ved hjælp af pålidelige diagnosticeringsmetoder.
English: Protection starts to be effective 21 days after vaccination and lasts for 26 weeks after vaccination.
Danish: Vaccinens beskyttende virkning indtræder 21 dage efter vaccination og varer i 26 dage efter vaccinationen.
English: Suvaxyn PRRS MLV is a veterinary vaccine used to protect pigs against porcine respiratory and reproductive syndrome (PRRS).
Danish: Suvaxyn PRRS MLV er et veterinærlægemiddel, der anvendes til at beskytte svin mod porcin reproduktions- og respirationssygdom (PRRS).
English: An overview of Suvaxyn PRRS MLV and why it is authorised in the EU
Danish: En oversigt over Suvaxyn PRRS MLV, og hvorfor det er godkendt i EU
English: Suvaxyn PRRS MLV is available as lyophilisate (a freeze-dried pellet) and solvent to make a suspension for injection and can only be obtained with a prescription.
Danish: Suvaxyn PRRS MLV fås som lyofilisat (en frysetørret pille) og solvens til injektionsvæske, suspension, og det udleveres kun på recept.
English: The effectiveness of Suvaxyn PRRS MLV was supported by laboratory studies.
Danish: Virkningen af Suvaxyn PRRS MLV blev underbygget af laboratoriestudier.
English: A study in piglets showed the vaccine starts to be effective 21 days after vaccination and four studies in piglets showed protection lasts up to 26 weeks.
Danish: To studier hos smågrise viste, at vaccinens virkning indtræder 21 dage efter vaccinationen, og fire studier hos smågrise viste, at beskyttelsen varer i op til 26 uger.
English: Suvaxyn PRRS MLV must also not be used in boars producing semen, as PRRS virus can be shed in semen.
Danish: Suvaxyn PRRS MLV må heller ikke anvendes hos orner, der producerer sæd, da PRRS-virus kan udskilles i sæd.
English: Other information about Suvaxyn PRRS MLV
Danish: Andre oplysninger om Suvaxyn PRRS MLV
English: Suvaxyn PRRS MLV is a vaccine.
Danish: Suvaxyn PRRS MLV er en vaccine.
English: Why is Suvaxyn PRRS MLV authorised in the EU?
Danish: Hvorfor blev Suvaxyn PRRS MLV godkendt i EU?
English: Suvaxyn PRRS MLV contains a weakened strain of PRRS virus.
Danish: Suvaxyn PRRS MLV indeholder en svækket stamme af PRRS-virus.
English: What is Suvaxyn PRRS MLV and what is it used for?
Danish: Hvad er Suvaxyn PRRS MLV, og hvad anvendes det til?
English: Two studies were conducted in female pigs, one which showed that single vaccination of female pigs 10 to 11 weeks before mating protected them against disease when exposed to the virus 26 weeks after vaccination.
Danish: Det ene viste, at en enkelt vaccination af hungrise 10 til 11 uger inden parring beskyttede dem mod sygdomme, når de blev udsat for virussen 26 uger efter vaccinationen.
English: What are the risks associated with Suvaxyn PRRS MLV?
Danish: Hvilke risici er der forbundet med Suvaxyn PRRS MLV?
English: Suvaxyn PRRS MLV is given as a single injection from 1 day of age to pigs for fattening.
Danish: Suvaxyn PRRS MLV gives som en enkelt injektion til fedesvin, der er én dag gamle eller derover.
English: For the full list of all side effects and restrictions with Suvaxyn PRRS MLV, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Suvaxyn PRRS MLV fremgår af indlægssedlen.
English: How is Suvaxyn PRRS MLV used?
Danish: Hvordan anvendes Suvaxyn PRRS MLV?
English: How does Suvaxyn PRRS MLV work?
Danish: Hvordan virker Suvaxyn PRRS MLV?
English: What benefits of Suvaxyn PRRS MLV have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Suvaxyn PRRS MLV?
English: In addition, the clear reference to the patient population (postmenopausal women) intended to treat should be added.
Danish: Desuden bør der indsættes en klar angivelse af den patientpopulation (postmenopausale kvinder), der tilsigtes behandlet.
English: The main studies supporting intravaginal application are Studies SCO 5109 and SCO 5174.
Danish: Hovedundersøgelserne til dokumentation af intravaginal påføring er SCO 5109 og SCO 5174.
English: Linoladiol N and Linoladiol HN are approved via national procedures in different member states.
Danish: Linoladiol N og Linoladiol HN er via nationale procedurer godkendt i en række medlemsstater.
English: The CHMP therefore recommended the deletion of this indication from the product information.
Danish: CHMP anbefalede derfor, at denne indikation slettes fra produktinformationen.
English: Whether twice weekly administration (with high oestrogen systemic exposure occurring twice a week) translates into lower risk than daily administration is currently unknown and represents an important matter of concern.
Danish: Hvorvidt administration to gange om ugen (med deraf følgende høj systemisk østrogeneksponering to gange om ugen) er ensbetydende med lavere risiko end daglig administration, vides på nuværende tidspunkt ikke og er et vigtigt spørgsmål.
English: Overall summary of the scientific evaluation of high concentration estradiol containing medicinal products for topical use
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler indeholdende estradiol til topisk anvendelse
English: The peak concentration of estradiol was reached 6 hours after application (median).
Danish: Spidskoncentrationen af estradiol blev nået 6 timer efter påføring (medianværdi).
English: In terms of pharmacovigilance data, a total of 11 cases were reported including spontaneous reports and literature cases.
Danish: Af lægemiddelovervågningsdata er der i alt 11 spontane indberetninger og tilfælde fra litteraturen.
English: In addition the restriction to 4 weeks use of these products is justified by the clinical data currently available.
Danish: Foruden begrænsningen af anvendelsen til fire uger bygger anvendelsen af disse produkter på de foreliggende kliniske data.
English: The CHMP noted that the available data on the safety of Linoladiol is limited and no prospective evaluation of safety, in particular endometrial safety was available.
Danish: CHMP bemærkede, at de foreliggende data om sikkerheden af Linoladiol var begrænsede, og at der ikke forelå en prospektiv vurdering af sikkerheden, navnlig den endometrielle sikkerhed.
English: Germany was concerned that these products containing estradiol, which are indicated only for local use, exhibit high blood concentration upon application, which is seen only with products authorised for systemic use.
Danish: Tyskland fandt det betænkeligt, at disse produkter, der indeholder estradiol og udelukkende er indiceret til lokal anvendelse, ved påføring medfører en høj blodkoncentration, som kun ses med produkter, der er godkendt til systemisk anvendelse.