FrancophonIA/ELRC3.0 huggingface dataset:
English: Masitinib was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 October 2009 for the treatment of pancreatic cancer.
Danish: Masiviera blev udpeget som "lægemiddel til sjældne sygdomme" den 28. oktober 2009 til behandling af bugspytkirtelkræft.
English: This means that it blocks certain enzymes known as tyrosine kinases.
Danish: Det vil sige, at stoffet blokerer enzymer af typen tyrosinkinaser.
English: The Committee confirmed its opinion that the effectiveness of Masiviera had not been sufficiently demonstrated in pancreatic cancer.
Danish: Udvalget fastholdt sin udtalelse om, at virkningen af Masiviera ved bugspytkirtelkræft ikke var tilfredsstillende påvist.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 22 May 2014.
Danish: CHMP gennemgik begrundelsen for anmodningen og foretog en fornyet overvejelse af den første udtalelse, men bekræftede den 22. maj 2014 afslaget på ansøgningen om markedsføringstilladelse.
English: These enzymes can be found in some receptors on the surface of cells, including the receptors that are involved in stimulating cancer cells to divide
Danish: Disse enzymer findes i visse receptorer på cellernes overflade, bl.a.
English: The company informed the CHMP that there were no consequences for patients in clinical trials or compassionate use programmes.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der deltager i kliniske undersøgelser eller i programmer for anvendelse med særlig udleveringstilladelse.
English: During the re-examination the CHMP looked again at the data from the company, including a proposal for a conditional authorisation in a restricted group of patients, and also consulted a group of experts in the treatment of pancreatic cancer.
Danish: Under den fornyede overvejelse gennemgik CHMP virksomhedens oplysninger, bl.a. forslag til en betinget godkendelse hos en begrænset gruppe patienter.
English: Although the company presented analyses suggesting that there was a benefit in a subgroup of patients with certain genetic changes associated with more aggressive disease, and in a subgroup of patients with pain, the study was not designed to show benefit in these smaller groups, and the Committee considered that further study would be needed to demonstrate such a benefit.
Danish: Virksomheden fremlagde analyser, der tydede på, at lægemidlet var til fordel for en undergruppe af patienter med nogle bestemte ændringer i arvematerialet, der bevirker, at sygdommen er mere aggressiv.
English: Pharmaceutical Form Route of administration Packaging
Danish: Lægemiddelform Indgivelsesvej
English: MA EU Number
Danish: MF (EU)-nummer
English: Immediate Packaging
Danish: Emballage Paknings-størrelse
English: (Invented) name Strength Pharmaceutical form Route of administration
Danish: Styrke Lægemiddelform Administration
English: Further information on Rxulti can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Rxulti findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Rxulti is available as tablets (0.25, 0.5, 1, 2, 3 and 4 mg) to be taken by mouth.
Danish: Rxulti fås som tabletter (0,25, 0,5, 1, 2, 3 og 4 mg), der tages gennem munden.
English: Rxulti (brexpiprazole)
Danish: Rxulti (brexpiprazol)
English: Schizophrenia is a mental illness with symptoms such as delusions, disorganised thinking and speech, suspiciousness and hallucinations (seeing, hearing or feeling things that are not there).
Danish: Skizofreni er en sindslidelse med symptomer som f.eks. vrangforestillinger, desorganiseret tankegang og tale, mistænksomhed og hallucinationer (opfattelsen af at se, høre eller mærke ting, som ikke er der).
English: In patients taking certain other medicines the doctor may need to adjust the dose of Rxulti.
Danish: Hos patienter, der tager visse andre lægemidler, kan lægen være nødt til at justere dosis af Rxulti.
English: The dose is then increased to 2 mg once daily taken on days 5, 6 and 7 and increased again if necessary to 4 mg once daily on day 8.
Danish: Dosen øges derefter til 2 mg én gang dagligt på dag 5, 6 og 7, hvorefter den om nødvendigt igen øges til 4 mg én gang dagligt på dag 8.
English: For more information about using Rxulti, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Rxulti, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Although the reductions in symptoms were not consistent across the studies, this often occurs in studies with antipsychotic medicines and the European Medicines Agency considered that the effects were sufficient to conclude that Rxulti is beneficial to patients with schizophrenia.
Danish: Selvom reduktionerne i symptomer ikke var konsistente mellem studierne, er det noget, som ofte ses i studier af antipsykotiske lægemidler, og Det Europæiske Lægemiddelagentur vurderede, at virkningen var tilstrækkelig til at kunne konkludere, at Rxulti er gavnlig hos patienter med skizofreni.
English: What measures are being taken to ensure the safe and effective use of Rxulti?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rxulti?
English: As for all medicines, data on the use of Rxulti are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Rxulti løbende overvåget.
English: Based on available data, it is not possible to say how Rxulti compares with other medicines of the same type.
Danish: Baseret på tilgængelige data er det ikke muligt at afgøre, hvordan Rxulti virker i forhold til andre lægemidler af samme type.
English: The recommended starting dose is 1 mg once daily for the first 4 days.
Danish: Den anbefalede startdosis er 1 mg én gang dagligt i de første 4 dage.
English: The active substance in Rxulti, brexpiprazole, is thought to attach to receptors (targets) in the brain for several neurotransmitters (substances nerve cells use to communicate with neighbouring cells) including dopamine, serotonin and noradrenaline.
Danish: Det aktive stof i Rxulti, brexpiprazol, menes at binde til receptorer (mål) i hjernen for adskillige neurotransmittere (stoffer, som nervecellerne anvender til at kommunikere med naboceller), herunder dopamin, serotonin og noradrenalin.
English: Side effects reported with Rxulti are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Rxulti vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: In patients with moderately or severely reduced kidney or liver function the dose should be limited to 3 mg once a day.
Danish: Hos patienter med moderat eller svært nedsat nyre- eller leverfunktion bør dosen højest være 3 mg én gang dagligt.
English: Rxulti contains the active substance brexpiprazole.
Danish: Rxulti indeholder det aktive stof brexpiprazol.
English: These neurotransmitters play a role in schizophrenia, and by acting at their receptors, brexpiprazole helps normalise the activity of the brain and reduce symptoms of schizophrenia.
Danish: Disse neurotransmittere spiller en rolle i skizofreni, og ved at påvirke deres receptorer medvirker brexpiprazol til at normalisere hjernens aktivitet og reducere symptomerne på skizofreni.
English: The Agency decided that Rxulti's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet afgjorde, at fordelene ved Rxulti opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Other information about Rxulti
Danish: Andre oplysninger om Rxulti
English: Rxulti has been shown to be effective at reducing symptoms of schizophrenia in 5 main studies involving 2,404 adults with schizophrenia, although there were some inconsistent results.
Danish: Det er påvist, at Rxulti er effektivt til at reducere symptomer på skizofreni i 5 hovedstudier med deltagelse af 2 404 voksne med skizofreni, om end der var nogle inkonsistente resultater.
English: What is Rxulti and what is it used for?
Danish: Hvad er Rxulti, og hvad anvendes det til?
English: Rxulti was more effective than placebo in preventing relapse: after a year, 14% of patients taking Rxulti had relapsed compared with 38% of patients taking placebo.
Danish: Rxulti var mere effektivt end placebo til at forebygge recidiv: Efter et års behandling havde 14 % af de patienter, der fik Rxulti, oplevet tilbagevenden af sygdommen sammenholdt med 38 % af de patienter, der fik placebo.
English: An overview of Rxulti and why it is authorised in the EU
Danish: En oversigt over Rxulti, og hvorfor det er godkendt i EU
English: Why is Rxulti authorised in the EU?
Danish: Hvorfor blev Rxulti godkendt i EU?
English: The recommended dose is between 2 and 4 mg daily and 4 mg is the maximum recommended daily dose.
Danish: Den anbefalede dosis er 2-4 mg dagligt, og 4 mg er den højeste anbefalede daglige dosis.
English: Rxulti can only be obtained with a prescription.
Danish: Rxulti udleveres kun efter recept.
English: The fifth study compared Rxulti with placebo over one year, and the main measure of effectiveness was the risk of relapse (worsening of symptoms).
Danish: Det femte studie sammenlignede Rxulti med placebo over et år, og det primære mål for virkning var risikoen for recidiv (forværring af symptomerne).
English: Rxulti was effective at reducing symptoms of schizophrenia.
Danish: Rxulti var effektivt til at reducere symptomer på skizofreni.
English: In 4 of the studies, Rxulti was compared with placebo (a dummy treatment) and the main measure of effectiveness was reduction of symptoms on a standard rating scale called PANSS (positive and negative syndrome scale) which ranges from a minimum of 30 (no symptoms) to a maximum of 210 (severest symptoms) after 6 weeks of treatment.
Danish: I 4 af studierne blev Rxulti sammenlignet med placebo (et ikke-aktivt stof), og det primære mål for virkning var reduktion af symptomerne på standardskalaen PANSS (positive og negative symptomer på skizofreni), der går fra et minimum på 30 (ingen symptomer) til et maksimum på 210 (sværeste symptomer) efter 6 ugers behandling.
English: Rxulti is an antipsychotic medicine used to treat schizophrenia in adults.
Danish: Rxulti er et antipsykotisk lægemiddel til behandling af skizofreni hos voksne.
English: The most common side effects with Rxulti are akathisia (a constant urge to move, which may affect around 6 in 100 people) and weight gain (which may affect around 4 in 100 people).
Danish: De hyppigste bivirkninger ved Rxulti er akatisi (en konstant trang til at bevæge sig, hvilket kan forekomme hos ca. 6 ud af 100 patienter) og vægtstigning (hvilket kan forekomme hos ca. 4 ud af 100 patienter).
English: What are the risks associated with Rxulti?
Danish: Hvilke risici er der forbundet med Rxulti?
English: Results at 2, 3 and 4 weeks showed improvement in symptoms with Rxulti compared with placebo.
Danish: Resultater efter 2, 3 og 4 uger viste en forbedring af symptomerne med Rxulti sammenholdt med placebo.
English: However, there was not considered to be a difference between 2 mg Rxulti and placebo.
Danish: Der sås dog ingen forskel mellem 2 mg Rxulti og placebo.
English: For the full list of side effects and restrictions with Rxulti, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Rxulti fremgår af indlægssedlen.
English: The safety profile of Rxulti is similar to other antipsychotic medicines.
Danish: Rxultis sikkerhedsprofil er magen til sikkerhedsprofilen ved andre antipsykotiske lægemidler.
English: In the fourth study, doses of Rxulti ranging from 2 to 4 mg were compared with placebo and with another antipsychotic medicine, quetiapine.
Danish: I det fjerde studie blev doser på 2-4 mg Rxulti sammenlignet med placebo og med et andet antipsykotisk middel (quetiapin).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rxulti 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 Rxulti.
English: How is Rxulti used?
Danish: Hvordan anvendes Rxulti?
English: Quetiapine showed improvement in symptoms at 6 weeks compared with placebo.
Danish: Der sås en forbedring af symptomerne efter 6 ugers behandling med quetiapin sammenholdt med placebo.
English: In the third study, the PANSS score fell by around 15 points with 2 mg Rxulti compared with 8 points with placebo and there was not considered to be a difference between 4 mg Rxulti and placebo.
Danish: I det tredje studie faldt PANSS-scoren med ca. 15 point med 2 mg Rxulti sammenholdt med 8 point med placebo, og der sås ingen forskel mellem 4 mg Rxulti og placebo.
English: How does Rxulti work?
Danish: Hvordan virker Rxulti?
English: What benefits of Rxulti have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Rxulti?
English: In the first study, the PANSS score fell by around 21 and 20 points with 2 mg and 4 mg Rxulti respectively compared with 12 points with placebo.
Danish: I det første studie faldt PANSS-scoren med ca. 21 og 20 point ved behandling med hhv. 2 mg og 4 mg Rxulti sammenholdt med 12 point ved behandling med placebo.
English: In the second study, the PANSS score fell by around 20 points with 4 mg Rxulti compared with 14 points with placebo.
Danish: I det andet studie faldt PANSS-scoren med ca. 20 point ved behandling med 4 mg Rxulti sammenholdt med 14 point ved behandling med placebo.
English: After 6 weeks, there was not considered to be a difference between Rxulti and placebo.
Danish: Der sås ingen forskel mellem Rxulti og placebo efter 6 ugers behandling.
English: Annex I List of medicinal products and presentations
Danish: LISTE OVER NATIONALT GODKENDTE LÆGEMIDLER
English: This summary was last updated on 30 August 2007.
Danish: Dette sammendrag blev sidst ajourført den 30. august 2007.
English: This document is a summary of the European Public Assessment Report.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport.
English: These reactions should disappear within two to three days.
Danish: Disse reaktioner forsvinder normalt inden for to til tre dage.
English: Only healthy dogs should be vaccinated.
Danish: Kun raske hunde må vaccineres.
English: This helps to reduce the symptoms of babesiosis.
Danish: Dette er med til at mindske symptomerne på babesiosis.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om grundlaget for CVMP's anbefalinger, kan du læse de faglige drøftelser (også en del af denne EPAR).
English: Re-vaccination is achieved with a single injection every six months.
Danish: Revaccination foretages med en enkelt injektion hver sjette måned.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Danish: Vacciner fungerer ved at 'lære' immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare sig mod sygdomme.
English: In general, these disappear within four days, but in rare cases they can persist for up to 14 days after the second injection.
Danish: Disse bivirkninger forsvinder normalt inden for fire dage, men kan i sjældne tilfælde vare ved i op til 14 dage efter den anden injektion.
English: The vaccine also contains an ‘adjuvant' (a compound called saponin) to stimulate a better response.
Danish: Vaccinen indeholder også en adjuvans (et stof, som kaldes saponin), der har til formål at stimulere en bedre respons.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Danish: Benefit/risk-forholdet fremgår af afsnit 6 i denne EPAR.
English: Dogs that are infected with B. canis but have no symptoms should be treated appropriately before vaccination.
Danish: Hunde, der er inficerede med B. canis, men ikke har symptomer, skal behandles på passende vis inden vaccination.
English: In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to B. canis.
Danish: Fremover vil immunsystemet være i stand til at danne antistoffer hurtigere, når det igen udsættes for B. canis.
English: Immunity starts three weeks after the vaccination course and lasts for at least six months.
Danish: Immuniteten opnås tre uger efter vaccinationsforløbet og varer i mindst seks måneder.
English: If accidental self-injection occurs, seek medical advice immediately and show the Package Leaflet or the label to the doctor.
Danish: Hvis der ved et uheld sker en selvinjektion, skal der omgående søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: When a dog is given the vaccine, the immune system recognises the antigens as ‘foreign' and makes antibodies against them.
Danish: Når en hund får vaccinen, opfatter immunsystemet antigenerne som fremmedlegemer og danner antistoffer mod dem.
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Danish: Formålet er at forklare, hvordan Udvalget for Veterinærlægemidler (CVMP) vurderede den fremlagte dokumentation og nåede frem til sine anbefalinger om, hvordan lægemidlet skal anvendes.
English: If mild symptoms occur and last for more than two days, veterinary advice should be sought.
Danish: Hvis der opstår milde symptomer, og de varer i over to dage, skal dyrlægen kontaktes.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nobivac Piro to Intervet International B.V. on 2 September 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nobivac Piro til Intervet International B.V.
English: Nobivac Piro is a vaccine.
Danish: Nobivac Piro er en vaccine.
English: The effects of vaccination were compared with those of vaccination using a placebo (a dummy treatment).
Danish: Effekterne af vaccinen blev sammenlignet med effekterne af vacciner med placebo (virkningsløs behandling).
English: After vaccination, painful swelling or hardened nodules occur commonly at the site of vaccination.
Danish: Efter vaccinationen opstår der ofte en smertefuld hævelse eller hårde knuder på vaccinationsstedet.
English: Vaccination with Novibac Piro does not prevent infection, so a milder form of disease caused by B. canis can occur.
Danish: Vaccination med Nobivac Piro forhindrer ikke infektion, og der kan derfor opstå en mildere form for sygdom forårsaget af B. canis.
English: Side effects such as lethargy (listlessness) and a reduction in appetite are also common, sometimes accompanied by fever and a stiff gait.
Danish: Andre almindelige bivirkninger er blandt andet letargi (apati) og nedsat appetit, der nogle gange ledsages af feber og en stiv gang.
English: Because the antigens on B. canis are very variable, vaccines against B. canis only work effectively if they also include antigens from B. rossi.
Danish: Da antigenerne på B. canis er meget varierende, er vacciner mod B. canis kun effektive, hvis de også indeholder antigener fra B. rossi.
English: It is recommended that the vaccination is given at least one month before the tick season and exposure to ticks be reduced during the vaccination period.
Danish: Det anbefales, at vaccinen gives mindst én måned før, sæsonen med skovflåter starter, og at hunde udsættes mindst muligt for skovflåter i vaccinationsperioden.
English: The main measure of effectiveness was the proportion of the dogs that developed antibodies against B. canis and B. rossi two weeks after the second injection.
Danish: Det primære mål for vaccinens effekt var den andel af hundene, der udviklede antistoffer mod B. canis og B. rossi to uger efter den anden injektion.
English: The effectiveness of Nobivac Piro has been studied in three laboratory studies in which dogs were vaccinated and then challenged (exposed to wild type Babesia).
Danish: Effekten af Nobivac Piro blev undersøgt i tre laboratorieundersøgelser, hvor hunde blev vaccineret og herefter belastet (udsat for vildtype-Babesia).
English: The vaccine can reduce the severity of symptoms caused by acute (short-lived) babesiosis (the disease caused by infection with B. canis, with weakness, fever and jaundice) and anaemia (low red blood cell counts).
Danish: Vaccinen kan mindske sværhedsgraden af symptomer, som er forårsaget af akut (kortvarig) babesiosis (den sygdom, der skyldes infektion med B. canis, som giver svaghed, feber og gulsot) og anæmi (lavt antal røde blodlegemer).
English: For initial vaccination, Nobivac Piro is given as two 1-ml injections under the skin three to six weeks apart.
Danish: Indledende gives vaccinen med Nobivac Piro i form af to 1 ml-injektioner under huden med tre til seks ugers mellemrum.
English: Nobivac Piro is a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Danish: Nobivac Piro er et lyofilisat (frysetørret pille) og en solvens, der blandes til en suspension til injektion.
English: Further one main field study was performed, including dogs of at least six months of age of various breeds who received two injections of Nobivac Piro three weeks apart.
Danish: Der blev endvidere udført en central praktisk undersøgelse, hvor hunde, som var mindst seks måneder gamle og af forskellige racer, fik to injektioner med Nobivac Piro med tre ugers mellemrum.
English: Nobivac Piro is a vaccine that contains antigens (proteins) from the parasites Babesia canis and Babesia rossi.
Danish: Nobivac Piro er en vaccine, der indeholder antigener (proteiner) fra parasitterne Babesia canis og Babesia rossi.
English: Nobivac Piro was more effective than placebo at stimulating the production of antibodies: more dogs receiving the vaccine developed antibodies than those receiving placebo.
Danish: Nobivac Piro havde større effekt end placebo i forbindelse med at stimulere dannelsen af antistoffer: flere hunde, der fik vaccinen med Nobivac Piro, udviklede antistoffer end hunde, der fik vaccinen med placebo.
English: Nobivac Piro should not be used in bitches that are pregnant or lactating.
Danish: Nobivac Piro må ikke anvendes til drægtige eller diegivende tæver.
English: Nobivac Piro contains small amounts of antigens (soluble parasite antigens) from B. canis and the related species B. rossi that have been extracted from cultures of the parasites in red blood cells.
Danish: Nobivac Piro indeholder små mængder af antigener (opløselige parasitantigener) fra B. canis og den beslægtede art B. rossi, der er blevet ekstraheret fra kulturer af parasitterne i røde blodlegemer.
English: Nobivac Piro is used to vaccinate dogs aged six months or older against B. canis, a protozoan (single-celled organism) transmitted by ticks that lives in red blood cells.
Danish: Nobivac Piro anvendes til vaccination af hunde i alderen seks måneder eller ældre mod B. canis, som er et protozo (encellet organisme), der overføres af skovflåter, og som lever i røde blodlegemer.