FrancophonIA/ELRC3.0 huggingface dataset:
English: The target species are: pigs, chickens, turkeys and rabbits.
Danish: De tilsigtede arter er: Grise, kyllinger, kalkuner og kaniner.
English: The referral procedure started on 15 October 2008.
Danish: Indbringelsesproceduren blev indledt den 15. oktober 2008.
English: Written explanations were provided by the marketing authorisation holders on 20 April 2009 and 16 November 2009.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 20. april 2009 og den 16. november 2009.
English: Tiamulin is used for the treatment and prevention of gastrointestinal and respiratory infections caused by different bacterial pathogens in pigs, poultry and rabbits.
Danish: Tiamulin anvendes til behandling og forebyggelse af gastrointestinale og respiratoriske infektioner forårsaget af forskellige bakterier i grise, fjerkræ og kaniner.
English: The rapporteur and co-rapporteur appointed were: Prof. Stane Srčič and Dr Karolina Törneke respectively.
Danish: Den udpegede rapportør og medrapportør var prof. Stane Srčič og dr. Karolina Törneke.
English: Due to differences among the nationally authorised summaries of product characteristics for Tiamutin premix and associated names across the European Union, especially as regards indications for use, amount to be administered and administration route and withdrawal periods, on 18 September 2008 Ireland and Belgium referred the matter to the European Medicines Agency under Article 34 of Directive 2001/82/EC.
Danish: På grund af forskelle mellem de nationalt godkendte produktresuméer for Tiamutinpremix og tilknyttede navne i Den Europæiske Union hvad angår indikationer for anvendelse, den mængde, der skal anvendes, indgivelsesveje og tilbageholdelsesperioder, indbragte Irland og Belgien sagen for EMA den 18. september 2008 i henhold til artikel 34 i direktiv 2001/82/EF.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP adopted, on 10 March 2010, an opinion recommending the amendment of the marketing authorisations in terms of the summary of the product characteristics and labelling in order to harmonise the indications for use, amount to be administered and administration route and withdrawal periods.
Danish: På grundlag af rapportørernes vurdering af de aktuelt foreliggende data vedtog CVMP den 10. marts 2010 en udtalelse, hvori det anbefalede at ændre markedsføringstilladelserne for så vidt angår produktresuméer og etikettering med henblik på at harmonisere indikationerne for anvendelse, den mængde, der skal anvendes, og tilbagetrækkelsesperioderne.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended summary of product characteristics and labelling in Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II, og det ændrede produktresumé og den ændrede etikettering og indlægsseddel findes i bilag III.
English: Premixes containing tiamulin are marketed across the European Union under a variety of invented names and the authorised premix formulations are based on tiamulin hydrogen fumarate in a variety of concentrations: 0.8%, 2%, 10% and 80%.
Danish: De godkendte forblandinger er baseret på tiamulinhydrogenfumarat i forskellige koncentrationer: 0,8 %, 2 %, 10 % og 80 %.
English: Tiamulin is a semi-synthetic antibiotic belonging to the pleuromutilin group of antibiotics and it is used only in veterinary medicine.
Danish: Det tilhører antibiotika af pleuromutilin-gruppen og anvendes kun i veterinærlægemidler.
English: referral for Tiamutin premix and associated names
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel om Tiamutinpremix og tilknyttede navne
English: This overview was last updated in 12-2018.
Danish: Denne oversigt blev sidst ajourført i 12-2018.
English: Yervoy received a marketing authorisation valid throughout the EU on 13 July 2011.
Danish: Yervoy fik en markedsføringstilladelse med gyldighed i hele EU den 13. juli 2011.
English: Further information on Yervoy can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Yervoy.
Danish: Yderligere information om Yervoy findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Yervoy.
English: Advanced melanoma
Danish: Fremskredent melanom
English: Other information about Yervoy
Danish: Andre oplysninger om Yervoy
English: What measures are being taken to ensure the safe and effective use of Yervoy?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Yervoy?
English: As for all medicines, data on the use of Yervoy are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Yervoy løbende overvåget.
English: Yervoy is given by infusion (drip) into a vein over 90 minutes and the dose depends on the patient's body weight.
Danish: Yervoy gives ved infusion (drop) i en vene over 90 minutter, og dosis afhænger af patientens kropsvægt.
English: However, about one-third of the patients could not complete Yervoy treatment due to side effects.
Danish: Ca. en tredjedel af patienterne kunne dog ikke gennemføre behandlingen med Yervoy på grund af bivirkninger.
English: Why is Yervoy authorised in the EU?
Danish: Hvorfor blev Yervoy godkendt i EU?
English: Therefore, all adolescents treated with Yervoy will be monitored closely.
Danish: Alle unge, der behandles med Yervoy, vil derfor blive overvåget tæt.
English: For more information about using Yervoy, see the package leaflet or contact a doctor or pharmacist.
Danish: For mere information om anvendelse af Yervoy, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: The effects of Yervoy in adolescents are expected to be similar to those in adults.
Danish: Virkningerne af Yervoy hos unge forventes at svare til virkningerne hos voksne.
English: An overview of Yervoy and why it is authorised in the EU
Danish: En oversigt over Yervoy og hvorfor det er godkendt i EU
English: What is Yervoy and what is it used for?
Danish: Hvad er Yervoy, og hvad anvendes det til?
English: The European Medicines Agency noted that Yervoy improves survival in melanoma, a condition where overall survival rates are low.
Danish: Det Europæiske Lægemiddelagentur bemærkede, at Yervoy forbedrer overlevelsen ved melanom, hvor den samlede overlevelsesprocent er lav.
English: The Agency decided that Yervoy's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede, at fordelene ved Yervoy opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Patients will also receive from their doctor an alert card summarising key safety information on the medicine.
Danish: Patienterne skal derudover have udleveret et patientinformationskort af deres læge med en sammenfatning af de vigtigste sikkerhedsoplysninger om lægemidlet.
English: Side effects reported with Yervoy are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Yervoy vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific target in the body.
Danish: Et monoklonalt antistof er en type protein, der er udformet, så det genkender et bestemt mål i kroppen og bindes til det.
English: Because the medicine has been studied in very few adolescents, there is uncertainty about the medicine's side effects.
Danish: Da lægemidlet kun er undersøgt hos meget få unge, hersker der usikkerhed om lægemidlets bivirkninger.
English: In addition, 41.6% of patients (177 out of 423) responded to the treatment with the combination compared with 26.5% (112 out of 416) of those receiving sunitinib.
Danish: Desuden reagerede 41,6 % af patienterne (177 ud af 423) på kombinationsbehandlingen, sammenlignet med 26,5 % (112 ud af 416) af dem, der fik sunitinib.
English: Ipilimumab increases the number and the activity of a type of white blood cells called T cells which form part of the immune system and which can kill cancer cells.
Danish: Ipilimumab øger antallet af og aktiviteten i en type hvide blodlegemer kaldet T-celler, der er en del af immunsystemet, og som kan dræbe kræftceller.
English: It acts on T cells by attaching to and blocking the activity of CTLA-4, a protein that controls the activity of T cells.
Danish: Det virker på T-cellerne ved at binde sig til og blokere aktiviteten af proteinet CTLA-4, som styrer T-cellernes aktivitet.
English: The doctor may delay doses if certain side effects occur, and stop treatment altogether if side effects are severe.
Danish: Lægen kan udsætte doserne, hvis der opstår visse bivirkninger, og helt standse behandlingen, hvis bivirkningerne er svære.
English: As it is not clear how much Yervoy contributes to the benefits when given in combination with nivolumab in patients with advanced renal cell carcinoma, the company must conduct a study to determine the precise contribution of Yervoy and if the risks associated with Yervoy can be further minimised.
Danish: Da det ikke er klart, i hvor høj grad Yervoy bidrager til fordelene, når det gives i kombination med nivolumab, hos patienter med fremskredent renalcellekarcinom, skal virksomheden foretage et studie med henblik på at bestemme Yervoys præcise bidrag, og om de risici, der er forbundet med Yervoy, kan minimeres yderligere.
English: Yervoy is usually used in combination with another medicine, nivolumab, but can also be used on its own for melanoma.
Danish: Yervoy anvendes normalt i kombination med et andet lægemiddel, nivolumab, men kan også anvendes alene til behandling af melanom.
English: What are the risks associated with Yervoy?
Danish: Hvilke risici er der forbundet med Yervoy?
English: Yervoy can only be obtained with a prescription and treatment should be started and supervised by a specialist doctor experienced in treating cancer.
Danish: Yervoy udleveres kun efter recept, og behandlingen bør påbegyndes og overvåges af en speciallæge med erfaring i behandling af kræft.
English: For renal cell carcinoma, Yervoy is given to patients who have not been treated before and are at moderate or high risk of their cancer getting worse.
Danish: Ved renalcellekarcinom gives Yervoy til patienter, som ikke tidligere er blevet behandlet, og som har en moderat eller høj risiko for, at deres kræft forværres.
English: The most common side effects (which may affect more than 1 in 10 people) are diarrhoea, rash, itching, tiredness, nausea (feeling sick), vomiting, decreased appetite and abdominal pain (belly ache).
Danish: De hyppigste bivirkninger (som kan forekomme hos mere end 1 ud af 10 personer) er diarré, udslæt, kløe, træthed, kvalme, opkastning, nedsat appetit og mavesmerter.
English: Yervoy is commonly associated with side effects resulting from excessive activity of the immune system, including severe reactions and inflammation.
Danish: Yervoy er almindeligvis forbundet med bivirkninger, der skyldes høj aktivitet i immunsystemet, herunder svære reaktioner og betændelse.
English: Because studies with Yervoy have included very few adolescents, the company has committed to collecting information on side effects, including any effects on growth and sexual maturation.
Danish: Da studierne af Yervoy kun har omfattet meget få unge, har virksomheden forpligtet sig til at indsamle oplysninger om bivirkninger, herunder eventuelle følger for vækst og kønsmodning.
English: The active substance in Yervoy, ipilimumab, is a monoclonal antibody.
Danish: Det aktive stof i Yervoy, ipilimumab, er et monoklonalt antistof.
English: However, patients treated with the higher dose had more side effects and were less likely to complete treatment as a result.
Danish: Patienter behandlet med den høje dosis havde dog flere bivirkninger og var derfor mindre tilbøjelige til at gennemføre behandlingen.
English: The most frequent side effects of the medicine are mild to moderate in severity.
Danish: De hyppigste bivirkninger ved lægemidlet er lette til moderate.
English: In the treatment of advanced renal cell carcinoma, Yervoy in combination with nivolumab also increases patients' survival, and side effects are considered acceptable.
Danish: Ved behandlingen af fremskredent renalcellekarcinom vil Yervoy i kombination med nivolumab også øge patienternes overlevelse, og bivirkningerne anses for acceptable.
English: Most will improve with appropriate treatment or on stopping Yervoy.
Danish: De fleste bivirkninger fortager sig ved passende behandling eller ved ophør af behandlingen med Yervoy.
English: Advanced renal cell carcinoma
Danish: Fremskredent renalcellekarcinom
English: The company that markets Yervoy must ensure that all healthcare professionals expected to prescribe the medicine as well as patients are given a brochure with safety information on the medicine including the side effects resulting from excessive activity of the immune system.
Danish: Virksomheden, der markedsfører Yervoy, skal sørge for, at alle sundhedspersoner, som forventes at ordinere Yervoy, såvel som alle patienter, får udleveret en folder med sikkerhedsinformation om lægemidlet, herunder bivirkninger, der skyldes forhøjet immunsystemaktivitet.
English: The results showed that in patients at moderate or high risk of their cancer getting worse, patients given the combination lived overall longer than those given sunitinib.
Danish: Af resultaterne fremgik det, at hos patienter med moderat eller høj risiko for sygdomsforværring levede patienter, der fik kombinationsbehandlingen, samlet set længere end dem, der fik sunitinib.
English: Yervoy contains the active substance ipilimumab.
Danish: Yervoy indeholder det aktive stof ipilimumab.
English: In the treatment of melanoma, despite longer survival with a dose of 10 mg per kg, the Agency recommended using Yervoy at a dose of 3 mg per kg because the higher dose caused more side effects and worsened patients' quality of life after the start of treatment.
Danish: Selv om overlevelsestiden ved behandling af melanom var længere ved en dosis på 10 mg/kg, anbefalede agenturet, at Yervoy anvendes i en dosis på 3 mg/kg, da den højere dosis gav flere bivirkninger og ringere livskvalitet efter behandlingens start.
English: Several studies have shown that Yervoy is effective in prolonging the lives of patients with advanced melanoma.
Danish: Af flere studier fremgår det, at Yervoy forlænger levetiden for patienter med fremskredent melanom.
English: In the second study involving 142 adults, the disease was controlled in 56% of patients receiving Yervoy and nivolumab compared with 9% of patients receiving Yervoy alone.
Danish: I det andet studie, hvori 142 voksne deltog, var sygdommen under kontrol hos 56 % af de patienter, der fik Yervoy og nivolumab, sammenlignet med 9 % af dem, der fik Yervoy alene.
English: The time patients lived before their disease got worse was 11.6 months with the combination compared with 8.4 with sunitinib.
Danish: Tidsrummet, hvor patienterne levede, uden at deres sygdom forværredes, var 11,6 måneder for kombinationsbehandlingen, sammenlignet med 8,4 for behandlingen med sunitinib.
English: Additional common side effects when Yervoy is used with nivolumab include fever, reduced or increased levels of thyroid hormones, colitis (inflammation of the lower gut), joint pain, headache and breathing difficulty.
Danish: Yderligere hyppige bivirkninger ved brug af Yervoy sammen med nivolumab omfatter feber, reduceret eller forhøjet indhold af skjoldbruskkirtelhormoner, tyktarmsbetændelse (colitis), ledsmerter, hovedpine og åndenød.
English: For the full list of side effects and restrictions with Yervoy, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Yervoy fremgår af indlægssedlen.
English: When Yervoy is used alone, the patient receives a dose every 3 weeks for a total of 4 doses.
Danish: Når Yervoy anvendes alene, skal patienten have i alt 4 doser, der gives hver 3. uge.
English: Yervoy is a cancer medicine used in adults and adolescents from 12 years of age with advanced melanoma (a type of skin cancer) and in adults with advanced renal cell carcinoma (a kidney cancer).
Danish: Yervoy er et kræftlægemiddel, der anvendes hos voksne og unge fra 12 år med fremskredent melanom (en type hudkræft) og hos voksne med fremskredent renalcellekarcinom (nyrekræft).
English: Finally, two studies found the combination of Yervoy and nivolumab effective for treating advanced melanoma in adults who had not been treated previously, and whose cancer produced a protein called PD-L1.
Danish: I to studier viste en kombination afYervoy og nivolumab sig sluttelig at være effektiv til behandling af fremskredent melanom hos voksne, der ikke tidligere var behandlet, og hos hvem kræften dannede et protein kaldet PD-L1.
English: In two small studies involving a total of 30 adolescents aged 12 to 18 years with advanced melanoma, treatment with Yervoy produced similar levels of medicine in blood as in adults.
Danish: I to små studier med deltagelse af i alt 30 unge i alderen 12-18 år med fremskredent melanom frembragte behandling med Yervoy samme indhold af lægemidlet i blodet som hos voksne.
English: In the first of these studies involving 945 adults, patients treated with Yervoy and nivolumab lived for 11.7 months on average without their disease getting worse compared with 6.9 months for those treated with nivolumab alone and 2.9 months for those treated with Yervoy alone.
Danish: I det første af disse studier, hvori 945 voksne deltog, levede patienter, der blev behandlet med Yervoy og nivolumab, i gennemsnit i 11,7 måneder uden sygdomsforværring, sammenlignet med 6,9 måneder for dem, der blev behandlet med nivolumab alene, og 2,9 måneder for dem, der blev behandlet med Yervoy alene.
English: Several other studies involving previously untreated adults found that patients treated with Yervoy at 3 mg per kg lived for 13.5 months on average.
Danish: Af flere andre studier med deltagelse af tidligere ubehandlede voksne fremgik det, at patienter, der blev behandlet med Yervoy, 3 mg/kg, i gennemsnit levede i 13,5 måneder.
English: When used with nivolumab, the patient receives a dose of Yervoy and of nivolumab every 3 weeks for 4 doses followed by treatment with nivolumab alone.
Danish: Når Yervoy anvendes sammen med nivolumab, skal patienten have i alt 4 doser Yervoy og nivolumab, der gives hver 3. uge, efterfulgt af behandling med nivolumab alene.
English: In a study involving 502 adults whose advanced melanoma had not been treated previously, patients treated with high-dose Yervoy and dacarbazine lived for 11 months on average, compared with 9 months for those given placebo (a dummy treatment) plus dacarbazine.
Danish: I et studie med deltagelse af 502 voksne, hvis fremskredne melanom ikke tidligere var blevet behandlet, levede patienter, der blev behandlet med høje doser af Yervoy og dacarbazin, i gennemsnit i 11 måneder, sammenlignet med 9 måneder for dem, der fik placebo (en uvirksom behandling) plus dacarbazin.
English: In a study involving 676 adults in whom previous treatment for advanced melanoma had not worked or had stopped working, overall survival with Yervoy combined with an experimental medicine called ‘gp100' was 10 months, compared with 6 months in patients receiving gp100 alone.
Danish: I et studie med deltagelse af 676 voksne, hos hvem forudgående behandling for fremskredent melanom ikke havde virket eller var holdt op med at virke, var den samlede overlevelsestid med Yervoy, kombineret med et eksperimentelt lægemiddel kaldet "gp100", 10 måneder, sammenlignet med 6 måneder for patienter, der udelukkende fik gp100.
English: What benefits of Yervoy have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Yervoy?
English: One main study involving 1,096 adults with previously untreated advanced renal cell carcinoma compared treatment with Yervoy and nivolumab versus treatment with another cancer medicine for renal cell carcinoma, sunitinib.
Danish: I et hovedstudie med deltagelse af 1 096 voksne med tidligere ubehandlet fremskredent renalcellekarcinom blev behandling med Yervoy og nivolumab, sammenlignet med behandling med sunitinib, et andet kræftlægemiddel mod renalcellekarcinom.
English: In a study involving 727 adults with advanced melanoma, patients treated with Yervoy 3 mg per kg lived for around 12 months on average compared with 16 months for those treated with 10 mg per kg.
Danish: I et studie med deltagelse af 727 voksne med fremskredent melanom levede patienter, der fik Yervoy, 3 mg/kg, i gennemsnit i omkring 12 måneder, sammenlignet med 16 måneder for dem, der fik 10 mg/kg.
English: After 24 months, 66.5% of patients given the combination were alive compared with 52.9% in the sunitinib group.
Danish: 66,5 % af de patienter, der fik kombinationsbehandlingen, stadig i live, sammenlignet med 52,9 % af dem, der fik sunitinib.
English: How is Yervoy used?
Danish: Hvordan anvendes Yervoy?
English: How does Yervoy work?
Danish: Hvordan virker Yervoy?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Yervoy have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Yervoy.
English: The effectiveness of the vaccine was first studied in a number of laboratory studies in pigs.
Danish: Effektiviteten af vaccinen blev først undersøgt i en række laboratorieundersøgelser hos svin.
English: Affected pigs often have a cough and fail to thrive.
Danish: Ofte får de pågældende svin hoste og trives dårligt.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner virker ved at "lære" immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare organismen mod en sygdom.
English: Protection starts three weeks after vaccination and lasts for 23 weeks after vaccination.
Danish: Beskyttelsen begynder tre uger efter vaccinationen og varer i 23 uger efter vaccinationen.
English: In the future, if the animals are exposed to the virus or the bacteria the immune system will be able to respond more quickly.
Danish: Hvis dyret efterfølgende igen udsættes for virusset eller bakterien, vil immunsystemet reagere hurtigere.
English: Swelling, less than 2 cm in diameter, heat, redness at the injection site and pain to the touch which may last up to 2 days were also seen.
Danish: Der blev også set hævelse, mindre end 2 cm i diameter, varme, rødme på injektionsstedet og smerte ved berøring, som kan vare i op til 2 dage.
English: The full EPAR for Suvaxyn Circo+MH RTU can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Suvaxyn Circo+MH RTU findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Suvaxyn Circo+MH RTU on 6 November 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Suvaxyn Circo+MH RTU den 6. november 2015.
English: The withdrawal period for meat from pigs treated with Suvaxyn Circo+MH RTU for is ‘zero' days, which means there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød fra svin, der behandles med Suvaxyn Circo+MH RTU, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)
Danish: vaccine mod porcint circovirus og porcin enzootisk pneumoni (inaktiveret)