FrancophonIA/ELRC3.0 huggingface dataset:
English: It is used in pigs to treat or prevent a number of infectious diseases that are caused by bacteria and affect the lungs (i.e. swine enzootic pneumonia) or the gut (i.e. swine dysentery, porcine proliferative enteropathy or porcine colonic spirochaetosis).
Danish: Det anvendes hos svin til at behandle eller forebygge en række bakterielle infektionssygdomme i lungerne (enzootisk pneumoni) eller tarmen (svinedysenteri, porcin proliferativ enteropati eller porcin kolon-spirochaetose).
English: People known to be allergic to valnemulin should use Econor with caution.
Danish: Personer, som er overfølsomme (allergiske) over for valnemulin, bør udvise forsigtighed ved brug af Econor.
English: In rabbits, Econor is used to reduce mortality during an outbreak of epizootic rabbit enteropathy (ERE).
Danish: Hos kaniner anvendes Econor til at mindske dødeligheden ved udbrud af epizootisk enteropati.
English: ERE commonly occurs in commercial rabbit farms during the post-weaning fattening period.
Danish: Epizootisk enteropati hos kaniner optræder ofte på industrielle kaninfarme i opfedningsperioden efter fravænning.
English: In pigs, serious adverse drug reactions following the use of Econor are mainly associated with breeds and cross breeds of Danish and/or Swedish Landrace.
Danish: Alvorlige bivirkninger efter brug af Econor hos svin optræder hovedsagelig i forbindelse med dansk og/eller svensk landrace og blandingsracer heraf.
English: In a study involving 1,152 weaned rabbits, after an outbreak of ERE, treatment with Econor for 21 days reduced mortality during a 4 week period from 23% in untreated rabbits to 11% in those given 20 mg valnemulin per kg of feed, and about 8% in those given 35 mg valnemulin per kg feed.
Danish: I et studie med 1.152 fravænnede kaniner efter et udbrud af epizootisk enteropati mindskede behandlingen med Econor i 21 dage dødeligheden i en periode på fire uger fra 23 % hos ubehandlede kaniner til 11 % hos kaniner, der fik 20 mg valnemulin pr. kg foder, og til ca. 8 % hos kaniner, der fik 35 mg valnemulin pr. kg foder.
English: Rabbits must not be given overdoses of Econor as this may disturb gastrointestinal flora (gut bacteria) leading to the development of enterotoxaemia (infection of the gut).
Danish: Kaniner må ikke få overdosis af Econor, da det kan give forstyrrelser i den gastrointestinale flora (tarmbakterier), hvilket kan medføre enterotoksæmi (tarmbetændelse).
English: How is Econor used?
Danish: Hvordan anvendes Econor?
English: If side effects occur, Econor-containing food should be immediately removed; severely affected pigs should be moved to clean, dry pens and given appropriate treatment.
Danish: Svært påvirkede svin bør flyttes til rene, tørre båse og gives passende behandling.
English: What benefits of Econor have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Econor?
English: Some pigs may also suffer oedema (swelling caused by fluid) or erythema (redness) on the hindquarters, and palpebral (eyelid) oedema.
Danish: Nogle svin kan desuden få ødem (hævelse pga. væskeansamling) eller rødme på bagfjerdingen samt hævede øjenlåg.
English: How does Econor work?
Danish: Hvordan virker Econor?
English: The most common side effects in pigs are pyrexia (high temperature) and a lack of appetite; in severe cases, they might become uncoordinated and remain lying down.
Danish: De hyppigste bivirkninger hos svin er forhøjet temperatur og manglende ædelyst.
English: In studies in the treatment and prevention of swine dysentery, Econor in feed at a dose of 3 to 4 mg valnemulin per kg bodyweight daily (i.e. 75 mg per kg feed) for at least 7 days successfully treated swine dysentery.
Danish: I studier vedrørende behandling og forebyggelse af svinedysenteri var Econor effektivt til behandling af svinedysenteri, når det blev tilsat foderet i en dosis på 3 til 4 mg valnemulin pr. kg kropsvægt dagligt (75 mg pr. kg foder) i mindst syv dage.
English: Econor at a dose of 1 to 1.5 mg valnemulin per kg bodyweight per day (i.e. 25 mg per kg feed) effectively prevented the development of the disease.
Danish: Econor forebyggede effektivt udvikling af sygdommen med en dosis på 1 til 1,5 mg valnemulin pr. kg kropsvægt dagligt (25 mg pr. kg foder).
English: In studies in the treatment and prevention of swine enzootic pneumonia, Econor in feed at a dose of 10 to 12 mg valnemulin per kg bodyweight daily (i.e. 200 mg per kg feed) for up to 4 weeks reduced lung lesions, improved clinical signs and pig growth rates compared to untreated pigs.
Danish: I studier vedrørende behandling og forebyggelse af enzootisk pneumoni hos svin mindskede Econor lungelæsionerne og bevirkede en bedring i de kliniske symptomer samt hurtigere vækst sammenholdt med ubehandlede svin ved tilsætning til foderet i en dosis på 10 til 12 mg valnemulin pr. kg kropsvægt dagligt (200 mg pr. kg foder) i op til fire uger.
English: In prevention of porcine colonic spirochaetosis (colitis), Econor in feed at a dose of 1 to 1.5 mg valnemulin per kg bodyweight daily (i.e. 25 mg per kg feed) was effective in controlling the clinical signs and prevented weight loss caused by the disease in untreated pigs.
Danish: Ved forebyggelse af porcin kolon-spirochaetose (tyktarmsbetændelse) gav Econor effektiv kontrol af de kliniske symptomer og forhindrede det vægttab, som sygdommen forårsager hos ubehandlede svin, ved tilsætning til foderet i en dosis på 1 til 1,5 mg valnemulin pr. kg kropsvægt dagligt (25 mg pr. kg foder).
English: For treatment of porcine proliferative enteropathy (ileitis), Econor in feed at a dose of 3 to 4 mg valnemulin per kg bodyweight daily (i.e. 75 mg per kg feed) for 10 days improved the clinical condition of the pigs, reduced diarrhoea and reduced weight loss.
Danish: Ved behandling af porcin proliferativ enteropati (tyndtarmsbetændelse) gav Econor bedring i svinenes kliniske tilstand, mindsket diarré og reduceret vægttab ved tilsætning til foderet i en dosis på 3 til 4 mg valnemulin pr. kg kropsvægt dagligt (75 mg pr. kg foder) i 10 dage.
English: Torisel received a marketing authorisation valid throughout the EU on 19 November 2007.
Danish: Torisel fik markedsføringstilladelse med gyldighed i hele EU den 19. november 2007.
English: It is given as an infusion lasting 30 to 60 minutes.
Danish: Det gives som en infusion, der varer 30 til 60 minutter.
English: As for all medicines, data on the use of Torisel are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Torisel løbende overvåget.
English: Other information about Torisel
Danish: Andre oplysninger om Torisel
English: Further information on Torisel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information om Torisel findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The main measure of effectiveness was how long patients lived without the disease getting worse.
Danish: Virkningen blev hovedsagelig målt på, hvor længe patienterne levede, uden at sygdommen forværredes.
English: Some side effects can be managed by interrupting treatment or reducing the dose.
Danish: Visse bivirkninger kan afhjælpes ved at afbryde behandlingen eller ved at nedsætte dosis.
English: Treatment with Torisel should continue until the medicine is no longer working or causes unacceptable side effects.
Danish: Behandlingen med Torisel bør fortsætte, indtil lægemidlet ikke længere er virksomt eller giver uacceptable bivirkninger.
English: What measures are being taken to ensure the safe and effective use of Torisel?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Torisel?
English: What is Torisel and what is it used for?
Danish: Hvad er Torisel, og hvad anvendes det til?
English: The European Medicines Agency decided that Torisel'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 Torisel opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Torisel contains the active substance temsirolimus.
Danish: Torisel indeholder det aktive stof temsirolimus.
English: Patients are given an antihistamine injection to prevent an allergic reaction around 30 minutes before each dose of Torisel.
Danish: Patienter får en antihistamininjektion for at forebygge en allergisk reaktion ca. 30 minutter inden hver dosis af Torisel.
English: An overview of Torisel and why it is authorised in the EU
Danish: En oversigt over Torisel og hvorfor det er godkendt i EU
English: Torisel must be given under the supervision of a doctor who has experience in the use of cancer medicines.
Danish: Torisel skal gives under opsyn af en læge med erfaring i anvendelse af lægemidler mod kræft.
English: Further information on the orphan designations can be found on the European Medicines Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (renal cell carcinoma: 6 April 2006, expired November 2017; mantle cell lymphoma: 6 November 2006).
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes på Det Europæiske lægemiddelagenturs websted: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (renalcellecarcinom: 6. april 2006, udløb november 2017; mantelcellelymfom: 6. november 2006).
English: Why is Torisel authorised in the EU?
Danish: Hvorfor blev Torisel godkendt i EU?
English: Each patient received one of two doses of Torisel or the most appropriate alternative cancer medicines chosen by the investigator.
Danish: Hver patient fik én ud af to doser af Torisel eller det bedst egnede alternativ valgt af undersøgelseslederen.
English: For more information about using Torisel, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Torisel, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: These diseases are rare, and Torisel was designated an ‘orphan medicine' (a medicine used in rare diseases) on various dates.
Danish: Disse sygdomme er sjældne, og Torisel blev udpeget som ”lægemiddel til sjældne sygdomme” på forskellige datoer.
English: Side effects reported with Torisel are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Torisel vurderes omhyggeligt, og der tages i givet fald nødvendige forholdsregler for at beskytte patienterne.
English: What are the risks associated with Torisel?
Danish: Hvilke risici er der forbundet med Torisel?
English: Since mTOR is involved in the control of cell division, Torisel prevents the division of cancer cells, slowing down the growth and spread of the cancer.
Danish: Da mTOR medvirker til at hæmme celledeling, forebygger Torisel delingen af kræftceller, hvilket får kræften til at vokse og sprede sig langsommere.
English: Patients were treated with 25 mg Torisel, with interferon alfa or with 15 mg Torisel in combination with interferon alfa.
Danish: Patienterne blev behandlet med 25 mg Torisel, med interferon alfa eller med 15 mg Torisel i kombination med interferon alfa.
English: Patients receiving Torisel lived for 4.8 months on average without their disease getting worse compared with 1.9 months in those receiving the alternative treatment.
Danish: Patienter, der fik Torisel, levede i gennemsnit i 4,8 måneder, uden at deres sygdom forværredes, sammenlignet med 1,9 måneder for dem, der fik andre behandlinger.
English: For mantle cell lymphoma, the recommended dose is 175 mg once a week for three weeks, followed by weekly doses of 75 mg.
Danish: For mantelcellelymfom er den anbefalede dosis 175 mg én gang ugentligt i tre uger efterfulgt af ugentlige doser a 75 mg.
English: Torisel is a medicine used to treat patients with the following types of cancer:
Danish: Torisel er et lægemiddel til behandling af voksne med følgende kræftformer:
English: For renal cell carcinoma, the recommended dose of Torisel is 25 mg once a week, but a 10-mg dose is recommended in patients with severe liver problems who have high levels of platelets in the blood.
Danish: Mod renalcellekarcinom er den anbefalede dosis af Torisel 25 mg en gang ugentligt, men en dosis på 10 mg anbefales hos patienter med svære leverproblemer, som har et højt indhold af blodplader i blodet.
English: • mantle cell lymphoma (a cancer of B cells, a type of white blood cell).
Danish: • mantelcellelymfom (B-cellekræft, dvs. kræft i de hvide blodlegemer).
English: In the body, temsirolimus attaches to a protein inside cells to make a ‘complex'.
Danish: Temsirolimus binder sig i kroppen til et protein, der findes i cellerne, hvorved det danner et "kompleks".
English: Torisel must not be used in people who are hypersensitive (allergic) to temsirolimus, to its metabolites (the substances that it is broken down into) including sirolimus (a medicine used to prevent rejection of transplanted kidneys), to polysorbate 80 or to any of the other ingredients of the medicine.
Danish: Torisel må ikke anvendes hos personer, som er overfølsomme (allergiske) over for temsirolimus, over for dets metabolitter (de stoffer, det nedbrydes til), herunder sirolimus (et lægemiddel, der anvendes til at forebygge afstødning af transplanterede nyrer), over for polysorbat 80 eller over for andre af lægemidlets indholdsstoffer.
English: The active substance in Torisel, temsirolimus blocks a protein called ‘mammalian target of rapamycin' (mTOR).
Danish: Det aktive stof i Torisel, temsirolimus, er et lægemiddel mod kræft, som virker ved at blokere et protein, der kaldes det "mammale mål for rapamycin" ("mammalian target of rapamycin", mTOR).
English: The most common side effects with Torisel (which may affect more than 1 in 5 patients) include infections, pneumonia (infection of the lungs), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), decreased appetite, hyperglycaemia (high blood sugar levels), hypercholesterolaemia (high blood cholesterol levels), dysgeusia (taste disturbances), difficulty breathing, nose bleeds, cough, vomiting, stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), rash, pruritus (itching), oedema (swelling), tiredness, weakness, fever and mucosal inflammation (inflammation of moist body surfaces).
Danish: De hyppigste bivirkninger ved Torisel (som kan forekomme hos mere end 1 ud af 5 patienter) er infektioner, pneumoni (lungeinfektion), trombocytopeni (lavt antal blodplader), anæmi (lavt antal røde blodlegemer), forringet appetit, hyperglykæmi (forhøjet blodsukker), hyperkolesterolæmi (højt kolesterolindhold i blodet), dysgeusi (smagsforstyrrelser), åndedrætsbesvær, næseblødning, hoste, opkastning, stomatitis (betændelse i mundslimhinden), diarré, kvalme, forstoppelse, udslæt, pruritus (kløe), ødem (hævelse), træthed, kraftesløshed, feber, betændelse i slimhinderne.
English: Patients receiving Torisel alone survived 10.9 months on average compared with 7.3 months in those receiving interferon alfa alone.
Danish: Patienter, der fik Torisel alene, overlevede i gennemsnit i 10,9 måneder sammenlignet med 7,3 måneder hos dem, der fik interferon alfa alene.
English: In mantle cell lymphoma, Torisel was found more effective than alternative cancer medicines (such as gemcitabine or fludarabine) in a main study involving 162 patients whose disease had come back after previous treatment or in whom other treatments had not worked.
Danish: Som middel mod kappecellelymfom blev Torisel påvist at være mere effektivt end andre lægemidler mod kræft (såsom gemcitabin eller fludarabin) i en hovedundersøgelse omfattende 162 patienter, hvis sygdom var vendt tilbage efter tidligere behandling, eller hos hvem andre behandlinger havde været uvirksomme.
English: Patients receiving the lower dose of Torisel in combination with interferon alfa survived for a similar time (8.4 months) as those taking interferon alfa alone.
Danish: Patienter, som fik den lavere dosis af Torisel i kombination med interferon alfa, overlevede lige så længe (8,4 måneder) som dem, der tog interferon alfa alene.
English: For the full list of side effects of Torisel, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger med Torisel fremgår af indlægssedlen.
English: Torisel is available as a concentrate and solvent that are made up into a solution for infusion (drip) into a vein.
Danish: Torisel leveres som koncentrat og solvens, der blandes til en infusionsvæske, opløsning, til indgivelse i en vene (drop).
English: In advanced renal cell carcinoma, a main study involving 626 patients with poor prognosis found Torisel more effective than interferon alfa (another medicine used in the treatment of cancer) at prolonging patients' survival.
Danish: I en hovedundersøgelse omfattende 626 patienter med en dårlig prognose blev Torisel som middel mod fremskredent renalcellekarcinom påvist at være mere effektivt end interferon alfa (et andet lægemiddel mod kræft) til at forlænge patienternes overlevelse.
English: The most serious side effects of Torisel are allergic (hypersensitivity) reactions, serious reactions that occur during the infusion or soon afterwards, infections, lung disorders including pneumonitis (inflammation of the lungs) and pulmonary embolism (blood clot in the lung), bleeding in the brain, kidney failure, tearing (perforation) of the intestine, complications affecting the healing of wounds, hyperglycaemia (high blood sugar), thrombocytopenia (low levels of platelets), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection) and hyperlipaemia (high blood levels of a type of fat).
Danish: De alvorligste bivirkninger forbundet med Torisel er allergiske reaktioner (overfølsomhedsreaktioner), alvorlige reaktioner under eller umiddelbart efter infusionen, infektioner, lungesygdomme såsom pneumonitis (lungebetændelse) og lungeemboli (blodprop i lungen), blødning i hjernen, nyresvigt, perforering af tarmen, komplikationer til sårheling, hyperglykæmi (forhøjet blodsukker), trombocytopeni (lavt antal blodplader), neutropeni (lavt antal neutrofiler, en type hvide blodlegemer, der bekæmper infektion) og hyperlipæmi (højt indhold af en type fedt i blodet).
English: Torisel is used in adults when the lymphoma has come back after previous treatment or if other treatments have not worked.
Danish: når lymfomet er vendt tilbage efter tidligere behandling, eller de ikke har reageret på andre behandlinger.
English: What benefits of Torisel have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Torisel?
English: How does Torisel work?
Danish: Hvordan virker Torisel?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Torisel 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 Torisel.
English: How is Torisel used?
Danish: Hvordan anvendes Torisel?
English: Torisel must not be used in patients with mantle cell lymphoma who have moderate or severe problems with their liver.
Danish: Torisel anbefales ikke hos mantelcellelymfompatienter med moderat til svær leversygdom.
English: Mantle cell lymphoma
Danish: Mantelcellelymfom
English: ‘Advanced' means that the cancer has started to spread;
Danish: • fremskredent renalcellekarcinom (en form for nyrekræft) Fremskreden betyder, at kræften er begyndt at brede sig
English: (Invented) name
Danish: (Særnavn ) Navn
English: Strength Pharmaceutical form
Danish: Lægemiddelform Administration Emballage
English: 10 (10x1) vials (multi-pack)
Danish: 10 (10x1) hætteglas (multipakning)
English: 4 vials + 4 ampoules
Danish: 4 hætteglas + 4 ampuller
English: 10 (10x 1+1) vials + ampoules (multi-pack)
Danish: 10 (10x(1+1)) hætteglas + ampuller (multipakning)
English: 1 vial + 1 ampoule
Danish: 1 hætteglas + 1 ampul
English: Immediate packaging
Danish: Intravenøss anvendelse
English: 1 vial
Danish: Styrke
English: Romania Alapis Romania s.r.l.
Danish: Alapis Romania s.r.l.
English: LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATIONS, APPLICANTS IN THE MEMBER STATES
Danish: FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Bulgaria Alapis Bulgaria Ltd., 29, Atanas Dukov Str. 1407, Sofia,
Danish: Alapis Bulgaria Ltd., 29, Atanas Dukov Str. 1407, Sofia, Bulgaria
English: Jud.IIfov, 077025, Romania
Danish: Strada Leordeni nr.13, Bragadiru, Jud.IIfov, 077025, Romania
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administration Emballage Paknings-størrelse
English: The European Commission granted a marketing authorisation valid throughout the European Union for Javlor on 21 September 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Javlor den 21. september 2009.
English: It contains the active substance vinflunine (25 mg/l).
Danish: Det indeholder det aktive stof vinflunin (25 mg/l).
English: The full EPAR for Javlor can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Javlor findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Javlor vinflunine
Danish: Javlor vinflunin
English: ‘Metastatic' means that the cancer has spread to other parts of the body.
Danish: "Metastatisk" betyder, at kræften har spredt sig til andre dele af kroppen.
English: This is a summary of the European public assessment report (EPAR) for Javlor.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Javlor.
English: Measures to prevent constipation, such as laxatives, are recommended after Javlor is given in the first week.
Danish: Midler til forebyggelse af forstoppelse, såsom laksativer, anbefales efter indgivelse af Javlor i den første uge.
English: The main measure of effectiveness was how long the patients lived.
Danish: Virkningen blev hovedsagelig bedømt på, hvor lang tid patienterne levede.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Javlor.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Javlor.
English: The CHMP decided that Javlor's benefits are greater than its risks and recommended that Javlor be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Javlor er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: It must also not be used in breastfeeding mothers.
Danish: Det må heller ikke anvendes hos kvinder, der ammer.
English: Other information about Javlor
Danish: Andre oplysninger om Javlor:
English: The recommended dose is 320 mg per m2. Javlor is given as a drip into a vein over a period of
Danish: Den anbefalede dosis er 320 mg pr. m2. Javlor indgives som drop i en vene af 20 minutters varighed hver tredje uge.
English: In this group, those given Javlor lived for 6.9 months compared with 4.3 months for patients who were not given the Javlor.
Danish: I denne gruppe overlevede de patienter, der blev behandlet med Javlor, i 6,9 måneder sammenlignet med 4,3 måneder for de patienter, der ikke blev behandlet med Javlor.