FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, when bleeding did occur, around 90% of bleeding episodes resolved with one injection of Alprolix.
Danish: Når blødninger forekom, blev de desuden i 90 % af tilfældene standset med én injektion af Alprolix.
English: It is not intended to provide practical advice on how to use Alprolix.
Danish: Det er ikke en praktisk vejledning i, hvordan Alprolix bør anvendes.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Alprolix, 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 Alprolix, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Alprolix 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 Alprolix findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: For the full list of all side effects and restrictions with Alprolix, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Alprolix fremgår af indlægssedlen.
English: Factor IX medicines can also potentially cause problems due to the formation of blood clots in the blood vessels.
Danish: Faktor IX-medicin kan også medføre problemer på grund af dannelsen af blodpropper i blodårerne.
English: Alprolix can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.
Danish: Alprolix udleveres kun efter recept, og behandlingen bør finde sted under opsyn af en læge med erfaring i behandling af hæmofili.
English: The dose and frequency of treatment depend on the patient's bodyweight and whether Alprolix is used to treat or prevent bleeding, as well as the severity of the patient's factor IX deficiency, the extent and location of the bleeding and the patient's age and health.
Danish: Dosis og hyppighed af indsprøjtningerne afhænger af patientens legemsvægt og af, om Alprolix skal anvendes til at behandle eller forebygge blødning, og desuden af, hvor alvorlig patientens mangel på faktor IX er, blødningens omfang og beliggenhed samt patientens
English: In the first study involving 123 adults and adolescents aged 12 years or above, patients given Alprolix as a weekly preventive treatment had around 3 bleeding episodes a year, patients given Alprolix as an every 10 days preventive treatment had around 2 bleeding episodes per year, and patients given Alprolix for treating bleedings on demand had around 18 bleeding episodes a year.
Danish: I det første studie, der omfattede 123 voksne og unge i alderen 12 år og derover, sås følgende: Patienter, der fik Alprolix som forebyggende behandling én gang ugentligt, havde ca. 3 blødningsepisoder pr. år, patienter, der fik Alprolix som forebyggende behandling hver 10. dag, havde ca. 2 blødningsepisoder pr. år, og patienter, der fik Alprolix til behandling af blødning efter behov, havde ca. 18 blødningsepisoder pr. år.
English: It replaces the missing factor IX, thereby helping the blood to clot and giving temporary control of bleeding.
Danish: Det erstatter den manglende faktor IX og medvirker derfor til blodets størkning, så der opnås midlertidig kontrol med blødningen.
English: In the second study in 30 children aged below 12 years, Alprolix was similarly effective: 2 bleeding episodes occurred per year on average and around 75% of bleeding episodes resolved with one injection.
Danish: I det andet studie hos 30 børn under 12 år, havde Alprolix en lignende virkning: Der sås i gennemsnit 2 blødningsepisoder pr. år, og 75 % af blødningsepisoderne blev standset med én indsprøjtning.
English: Some patients taking factor IX medicines may develop inhibitors (antibodies) against factor IX, causing the medicine to stop working and resulting in a loss of bleeding control.
Danish: Nogle patienter, der tager faktor IX-medicin, kan danne antistoffer (inhibitorer) mod faktor IX, hvilket medfører, at lægemidlet ikke længere virker, så kontrollen med blødning svigter.
English: What are the risks associated with Alprolix?
Danish: Hvilke risici er der forbundet med Alprolix?
English: Alprolix contains the active substance eftrenonacog alfa.
Danish: Det indeholder det aktive stof eftrenonacog alfa.
English: For more information about treatment with Alprolix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Alprolix, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For further information on how to use this medicine, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger om anvendelsen af Alprolix fremgår af produktresuméet (også en del af denne EPAR).
English: Studies show that Alprolix is effective at preventing and treating bleeding episodes in patients with haemophilia B and its safety is comparable to that of other factor IX products.
Danish: Studier har vist, at Alprolix er effektivt til at forebygge og behandle blødningsepisoder hos patienter med hæmofili B, og sikkerheden ved lægemidlet er sammenlignelig med sikkerheden ved andre faktor IX-lægemidler.
English: Alprolix is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Danish: Alprolix leveres som et pulver med opløsningsvæske (solvens), der blandes sammen til en opløsning, som gives ved injektion i en vene.
English: Alprolix is a medicine used to treat and prevent bleeding in patients with haemophilia B, an inherited bleeding disorder caused by lack of a clotting protein called factor IX.
Danish: Alprolix er et lægemiddel til behandling og forebyggelse af blødning ved den arvelige blødningsforstyrrelse hæmofili B, der skyldes mangel på blodstørkningsproteinet faktor IX.
English: For practical information about using Alprolix, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Alprolix, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Alprolix used?
Danish: Hvordan anvendes Alprolix?
English: What benefits of Alprolix have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Alprolix?
English: Patients with haemophilia B lack factor IX, a protein needed for normal clotting of the blood, and as a result, they bleed readily.
Danish: Patienter med hæmofili B mangler faktor IX, der er et protein, som behøves til blodets normale størkning.
English: How does Alprolix work?
Danish: Hvordan virker Alprolix?
English: Alprolix has been shown to be effective at both preventing and treating bleeding episodes in 2 main studies in patients with haemophilia B.
Danish: I 2 hovedundersøgelser af patienter med hæmofili B er det påvist, at Alprolix er effektivt til både at behandle og forebygge blødningsepisoder.
English: What is Graspa?
Danish: Hvad er Graspa?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom29 June 2018
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom29.
English: What was Graspa expected to be used for?
Danish: Hvad forventedes Graspa anvendt til?
English: It was to be used if the ALL did not improve with standard treatment or if it had come back after such treatment.
Danish: Det skulle anvendes, hvis ALL'en ikke blev forbedret med standardbehandling, eller hvis den vendte tilbage efter standardbehandling.
English: Asparaginase has been used to treat cancer for many years and is authorised in EU countries under several trade names.
Danish: Asparaginase er i mange år blevet anvendt til at behandle kræft, og det er godkendt i en række EU-lande under forskellige handelsnavne.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse med Graspa og har behov for yderligere oplysninger om din behandling, kan du kontakte den læge, der behandler dig.
English: On 22 June 2018, Erytech Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Graspa, for the treatment of acute lymphoblastic leukaemia (ALL).
Danish: Den 22. juni 2018 meddelte Erytech Pharma S.A. officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Graspa til behandling af akut lymfatisk leukæmi (ALL).
English: Withdrawal of the marketing authorisation application for Graspa (L-asparaginase)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Graspa (L-asparaginase)
English: Graspa was expected to be used in combination with other cancer medicines to treat adults and children with ALL that was not related to a particular genetic change (known as ‘Philadelphia chromosome negative').
Danish: Graspa skulle anvendes i kombination med andre kræftlægemidler til at behandle voksne og børn med ALL, som ikke var relateret til en specifik genetisk forandring (såkaldt Philadelphia-kromosom-negativ ALL).
English: The CHMP was concerned that the medicine contains a different type of asparaginase to that used in clinical studies and that the data provided were not sufficient to show how the medicine behaved in the body or how well it worked compared with other asparaginase medicines.
Danish: CHMP var betænkelig ved, at lægemidlet indeholder en anden type asparaginase end den, der var anvendt i kliniske studier, og at de fremlagte data ikke var tilstrækkelige til at påvise, hvordan lægemidlet opfører sig i kroppen, eller hvor godt det virker sammenholdt med andre asparaginase-midler.
English: Also, data were too limited to show how much Graspa's effectiveness was reduced by antibodies or how safe it was in children or after repeated treatments.
Danish: Data var også for begrænsede til at påvise i hvilken grad, antistoffer reducerede virkningen af Graspa, dets sikkerhed hos børn og efter gentagne behandlinger.
English: The company provided data from a main study which compared Graspa with asparaginase (not enclosed in blood cells) in 80 patients aged 1 to 55 years with Philadelphia chromosome negative ALL whose disease had not improved with other treatment or had come back.
Danish: Virksomheden fremlagde data fra et hovedstudie, der sammenlignede Graspa med asparaginase (der ikke var indkapslet i blodlegemer) hos 80 patienter i alderen 1-55 år, som havde Philadelphiakromosom-negativ ALL, der ikke var blevet bedre med anden behandling, eller som var vendt tilbage.
English: However, lymphoblastic leukaemia cells cannot produce the amino acid and therefore they take it from the blood since they need it for their rapid growth.
Danish: Celler med lymfatisk leukæmi kan imidlertid ikke danne aminosyren, og de tager den derfor fra blodet, da de har brug for den for at kunne vokse hurtigt.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Graspa.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, som i øjeblikket deltager i kliniske undersøgelser med Graspa.
English: Asparagine is an amino acid produced by healthy cells in the body.
Danish: Asparagin er en aminosyre, der dannes af raske celler i kroppen.
English: How does Graspa work?
Danish: Hvordan virker Graspa?
English: Further information on the orphan designation can be found here.
Danish: Yderligere oplysninger om lægemidler til sjældne sygdomme kan findes her.
English: Graspa is a cancer medicine that contains the active substance L-asparaginase that has been enclosed in red blood cells.
Danish: Graspa er et kræftlægemiddel, der indeholder det aktive stof L-asparaginase, som er indkapslet i røde blodlegemer.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that the data provided were not sufficient to conclude on Graspa's benefit and risk.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at de fremlagte data ikke var tilstrækkelige til at konkludere, at fordelen opvejer risiciene.
English: In Graspa, L-asparaginase is enclosed in red blood cells because it was expected that this would allow the enzyme to work while protecting it from being broken down in blood and from antibodies that may attach to it and stop it from working.
Danish: Graspa indeholder røde blodlegemer med indkapslet L-asparaginase, da det forventedes, at dette ville gøre det muligt for enzymet at virke, idet det beskyttede enzymet mod at blive nedbrudt i blodet og mod antistoffer, der kunne binde til det og få det til at holde op med at virke.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Graspa could not have been approved for the treatment of ALL.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP haft visse betænkeligheder og var af den foreløbige opfattelse, at Graspa ikke kunne være blevet godkendt til behandling af akut lymfatisk leukæmi.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that, because of lack of proven effectiveness, the benefits of Graspa did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Graspa ikke opvejede risiciene, da virkningen ikke var blevet påvist.
English: Graspa was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 27 October 2006 for ALL.
Danish: Graspa blev udpeget som "lægemiddel til sjældne sygdomme" den 27. oktober 2006 mod akut lymfatisk leukæmi.
English: Giving the enzyme L-asparaginase destroys asparagine in the blood and deprives the leukaemia cells of this amino acid, causing them to die.
Danish: Enzymet L-asparaginase ødelægger asparaginet i blodet; dermed kan leukæmiceller ikke få denne aminosyre, og det får dem til at dø.
English: Graspa was intended to be given by infusion (drip) into a vein.
Danish: Graspa skulle gives ved infusion via et drop i en blodåre.
English: Withdrawal of the marketing authorisation application for Graspa (L-asparaginase) EMA/431413/2018
Danish: EMA/431413/2018
English: This summary was last updated in October 2014.
Danish: Dette sammendrag blev sidst ajourført i oktober 2014.
English: Bovela is a vaccine.
Danish: Bovela er en vaccine.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Bovela on 22 December 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Bovela den 22/12/2014.
English: Other information about Bovela:
Danish: Andre oplysninger om Bovela:
English: The withdrawal period for Bovela for cattle is zero days.
Danish: Tilbageholdelsestiden for Bovela for kvæg er nul dage.
English: Protection starts three weeks after vaccination and lasts for one year.
Danish: Beskyttelsen begynder tre uger efter vaccinationen og vedvarer i et år.
English: Mucosal disease is usually fatal.
Danish: Slimhindesygdommen er sædvanligvis dødelig.
English: To prevent the birth of a PI calf the vaccine should be given at least three weeks before insemination/mating.
Danish: For at undgå fødsel af PI-kalve skal vaccinen gives mindst tre uger før insemination/bedækning.
English: In the future, if the animals are exposed to the virus the immune system will be able to respond more quickly.
Danish: Hvis dyret efterfølgende udsættes for virusset, vil immunsystemet reagere hurtigere.
English: The effectiveness of the vaccine was first studied in a number of laboratory studies in cattle.
Danish: Effektiviteten af vaccinen blev først undersøgt hos kvæg i en række laboratorieundersøgelser.
English: What is the risk associated with Bovela?
Danish: Hvilken risiko er der forbundet med Bovela?
English: However a severe form of BVD can occur, when cattle have a high temperature and bloody diarrhoea.
Danish: BVD kan imidlertid optræde i en svær form, hvor kvæget får høj temperatur og blodig diarré.
English: Bovela contains two BVDV strains (or types) modified by deletion of parts of two genes so that they can no longer cause disease.
Danish: Bovela indeholder to BVDV-stammer (eller -typer), som er modificeret ved, at man har fjernet dele af to af deres gener, så de ikke længere kan forårsage sygdom.
English: Bovine viral diarrhoea vaccine (modified live)
Danish: Bovin viral diarrévaccine (modificeret, levende)
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter indgivelsen af lægemidlet, før dyret kan slagtes, og kødet eller mælken kan anvendes til menneskeligt konsum.
English: Why has Bovela been approved?
Danish: Hvorfor blev Bovela godkendt?
English: The vaccine is given to cattle as a single injection into the muscle.
Danish: Vaccinen gives til kvæg som en enkelt injektion i muskelvæv.
English: The most common side effect (seen in more than 1 in 100 cattle) was an increase in body temperature (within the normal range) within four hours of vaccination, which spontaneously resolves within 24 hours.
Danish: Den hyppigste bivirkning (der optrådte hos mere end 1 ud af 100 stykker kvæg) var forhøjet kropstemperatur (inden for normalområdet) indtil fire timer efter vaccinationen.
English: In the field study 98.5% of vaccinated cattle sampled (range 269-274 animals) developed antibodies to both BVD virus types.
Danish: I feltundersøgelsen dannede 98,5 % af det undersøgte vaccinerede kvæg (269-274 dyr) antistoffer mod begge typer BVD-virus.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Danish: Ved utilsigtet selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: Bovela is a veterinary vaccine that contains two types of a modified live bovine viral diarrhoea (BVD) virus (BVDV-1 and BVDV-2).
Danish: Bovela er en vaccine til dyr indeholdende to typer modificeret levende bovin viral diarré (BVD)-virus (BVDV-1 og BVDV-2).
English: What is Bovela used for?
Danish: Hvad anvendes Bovela til?
English: Approximately half of the cattle were vaccinated with Bovela and the rest received a dummy injection.
Danish: Cirka halvdelen af kalvene blev vaccineret med Bovela, mens resten fik en virkningsløs injektion.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Bovela exceed the risks for the approved indication and recommended that Bovela be given a marketing authorisation.
Danish: Udvalget for Lægemidler til Dyr (CVMP) besluttede, at fordelene ved Bovela opvejer risiciene til den godkendte anvendelse, og anbefalede udstedelse af markedsføringstilladelse for Bovela.
English: The purpose of the studies was to establish how long it took for cattle to be fully protected, the length of time protection against BVD lasts, as well as the influence of maternal antibodies (transmitted from the mother) on the effectiveness of the vaccine in calves.
Danish: Formålet var at finde ud af, hvor længe det tog for kvæg at opnå fuld beskyttelse, hvor længe beskyttelsen mod BVD varede, og hvilken betydning antistoffer, der overføres fra moderdyret, havde på vaccinens virkning hos kalve.
English: It is available as a lyophilisate (freeze dried powder) and solvent for injection.
Danish: Det fås som lyofilisat (frysetørret pulver) og solvens til injektionsvæske.
English: What is Bovela?
Danish: Hvad er Bovela?
English: In pregnant cows, BVD infection can cause abortions or result in the birth of calves that are persistently infected (PI).
Danish: Hos drægtige køer kan infektion med BVD-virus medføre abort eller resultere i fødsel af persistent inficerede (PI) kalve.
English: PI animals tend never to reach their productive potential, have reduced fertility and are more susceptible to other diseases.
Danish: PI-dyr når aldrig op på den forventede produktion, er mindre frugtbare og er mere udsat for andre sygdomme.
English: However, for the vaccinated group the period of infection was either before vaccination or before the start of protection.
Danish: I den vaccinerede gruppe blev dyrene imidlertid smittet, før de blev vaccineret, eller før beskyttelsen fra vaccinen var begyndt at virke.
English: When Bovela is given to cattle the animals' immune system recognises the virus strains as ‘foreign' and makes antibodies against them.
Danish: Når Bovela gives til kvæg, registrerer dyrenes immunsystem virusstammerne som »fremmede« og reagerer ved at danne antistoffer mod dem.
English: In non-pregnant animals the infection is generally mild, with signs affecting the airways such as cough, and reduced milk yield.
Danish: Hos ikke drægtige dyr er infektionen sædvanligvis mild med symptomer fra luftvejene, såsom hoste, og nedsat mælkeydelse.
English: PI animals are a constant source of BVD virus, infecting other cattle in the herd.
Danish: PI-dyr er en konstant kilde til BVD-virus og smitter andre dyr i besætningen.
English: How has Bovela been studied?
Danish: Hvordan blev Bovela undersøgt?
English: This will help protect the cattle against BVD infections.
Danish: Dette beskytter kvæget mod infektioner med BVD.
English: Bovela is used to protect cattle against BVD viral infection.
Danish: Bovela anvendes til at beskytte kvæg mod infektion med BVD-virus.
English: What benefit has Bovela shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Bovela?
English: In the group vaccinated with Bovela five out of 1,216 (0.4%) newborn calves were persistently infected with the virus, whereas in the group given the dummy injection there were ten persistently infected newborn calves out of 1,183 born (0.8%).
Danish: I den gruppe, der fik en virkningsløs injektion, var der 10 nyfødte kalve med persistent infektion ud af 1 183 (0,8 %).
English: In the laboratory studies Bovela prevented PI in 100% of calves while the animals that received no vaccination gave birth to 100% PI calves.
Danish: I laboratorieundersøgelserne forebyggede Bovela PI hos 100 % af kalvene.
English: The main measure of effectiveness was the reduction in the number of persistently infected newborn calves as determined by virus specific identification tests.
Danish: Effektiviteten blev hovedsagelig bedømt på reduktionen i antallet af nyfødte kalve med PI. PI blev påvist ved prøver, der identificerer virusset.
English: They may progress to have mucosal disease which is another form of BVD disease with ulcers and blisters on the snout and inside of the mouth.
Danish: Hos disse dyr kan sygdommen udvikle sig til at angribe slimhinderne, som er en anden form af BVD-sygdommen, der medfører sår og blærer på mulen og i munden.
English: How does Bovela work?
Danish: Hvordan virker Bovela?
English: The effectiveness of Bovela was further investigated in the field in eight dairy cattle herds of which five of them had a history of BVD or persistent infection at the beginning of the study.
Danish: I fem af besætningerne havde der tidligere været BVD-infektion, eller der var persistent infektion, da undersøgelsen blev påbegyndt.
English: • If you are under 18 years of age.
Danish: - Hvis du er under 18 år gammel.
English: These may cause allergic reactions (possibly delayed).
Danish: Disse stoffer kan forårsage allergiske reaktioner (muligvis forsinkede).
English: • Wash your hands thoroughly.
Danish: • Vask hænderne omhyggeligt.
English: • If you have or have had cancer
Danish: - Hvis du har eller tidligere har haft kræft.