FrancophonIA/ELRC3.0 huggingface dataset:
English: It must also not be used if the ear drum is perforated, in dogs with generalised demodectic mange (skin infestation caused by a specific type of mite) or in pregnant or breeding animals.
Danish: Det må heller ikke anvendes, hvis trommehinden er perforeret, hos hunde med generaliseret demodicoseskab (hudangreb forårsaget af en bestemt type mide) eller hos drægtige dyr eller avlsdyr.
English: Neptra is a veterinary medicine used to treat dogs with short lived or recurrent ear infections (otitis externa) caused by two organisms: Staphylococcus pseudintermedius (a bacterium) and Malassezia pachydermatitis (a yeast).
Danish: Neptra er et veterinærlægemiddel, der anvendes til at behandle dyr med kortvarige eller gentagne øreinfektioner (otitis externa) forårsaget af to organismer: Staphylococcus pseudintermedius (et bakterie) og Malassezia pachydermatitis (en type af svampe).
English: Neptra (florfenicol / terbinafine / mometasone) EMA/560411/2019
Danish: Neptra (florfenicol / terbinafin / mometason) EMA/687933/2019
English: Neptra must not be used in dogs who are allergic to the active substances, to other corticosteroids or to any of the other ingredients.
Danish: Det må ikke anvendes til hunde, som er allergiske over for kortikosteroider eller andre af indholdsstofferne.
English: Side effects with Neptra occur very rarely, with the most often reported (which may affect up to 1 in 10,000 dogs) being whining, head shaking, nystagmus (uncontrolled eye movements), vomiting, inner ear disorders causing imbalance, loss of appetite, hyperactivity and application site pain and inflammation shortly after applying the medicine.
Danish: De hyppigst indberettede (som kan forekomme hos op til 1 ud af 10.000 hunde) er hylen, hovedrysten, nystagmus (ukontrollerede øjenbevægelser), opkast, forstyrrelser i det indre øre, som forårsager ubalance, appetitløshed, hyperaktivitet og smerter på påføringsstedet samt betændelse kort efter anvendelsen af lægemidlet.
English: Neptra contains three active substances: florfenicol, terbinafine and mometasone.
Danish: Neptra indeholder tre aktive stoffer: florfenicol, terbinafin og mometason.
English: In a field study in the US involving dogs again with ear infections due to both organisms, 67 dogs treated with Neptra had a reduction in clinical score of 77% over 30 days.
Danish: I et feltstudie i USA, hvori der også indgik hunde med øreinfektioner, som skyldes begge organismer, blev den kliniske score mindsket med 77 % i løbet af 30 dage hos 67 hunde, der blev behandlet med Neptra.
English: Terbinafine kills fungi by blocking the formation of ergosterol, an important part of fungal cell walls.
Danish: Terbinafin dræber svampen ved at forhindre dannelsen af ergosterol, som er en vigtig del af svampecellevæggene.
English: How is Neptra used?
Danish: Hvordan anvendes Neptra?
English: What benefits of Neptra have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Neptra?
English: In case of accidental swallowing medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Danish: Ved utilsigtet indtagelse skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: If symptoms develop, medical advice should be sought and the package leaflet or the label shown to the doctor.
Danish: Hvis der opstår symptomer, skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: How does Neptra work?
Danish: Hvordan virker Neptra?
English: Polivy has been given a ‘conditional authorisation'.
Danish: Polivy har fået en "betinget godkendelse".
English: The medicine must not be given to patients who have a severe infection.
Danish: Lægemidlet må ikke gives til patienter, der har en svær infektion.
English: Serious side effects can occur; however, these are manageable if appropriate measures are in place.
Danish: Der kan forekomme alvorlige bivirkninger, men de er håndterbare, hvis der træffes relevante foranstaltninger.
English: Other information about Polivy
Danish: Andre oplysninger om Polivy
English: As for all medicines, data on the use of Polivy are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Polivy løbende overvåget.
English: Polivy was investigated in a study involving 80 patients with DLBCL.
Danish: Polivy blev undersøgt i et studie hos 80 patienter med DLBCL.
English: Although the study included a limited number of patients and more data are needed to confirm the results, the European Medicines Agency considered that Polivy meets an unmet medical need.
Danish: Selvom studiet omfattede et begrænset antal patienter, og flere data er nødvendige for at bekræfte resultaterne, vurderede Det Europæiske Lægemiddelagentur, at Polivy opfylder et udækket medicinsk behov.
English: What measures are being taken to ensure the safe and effective use of Polivy?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Polivy?
English: Why is Polivy authorised in the EU?
Danish: Hvorfor er Polivy godkendt i EU?
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3182013.
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes her: ema.europa.eu/medicines/human/orphan-designations/eu3182013.
English: MMAE then stops the B cells from dividing and causes them to die.
Danish: MMAE forhindrer dermed B-cellerne i at dele sig, og det får dem til at dø.
English: The Agency therefore decided that Polivy's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Polivy opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: DLBCL is rare, and Polivy was designated an ‘orphan medicine' (a medicine used in rare diseases) on 16 April 2018.
Danish: DLBCL er sjælden, og Polivy blev udpeget som "lægemiddel til sjældne sygdomme" den 16. april 2018.
English: Polivy is for infusion (drip) into a vein over 90 minutes.
Danish: Polivy indgives ved infusion (drop) i en blodåre over 90 minutter.
English: If the patient develops an infusion-related reaction, the infusion should be slowed down or interrupted.
Danish: Hvis patienten udvikler en infusionsrelateret reaktion, bør infusionshastigheden sættes ned eller infusionen afbrydes.
English: An overview of Polivy and why it is authorised in the EU
Danish: En oversigt over Polivy, og hvorfor det er godkendt i EU
English: What is Polivy and what is it used for?
Danish: Hvad er Polivy, og hvad anvendes det til?
English: The main study showed that Polivy is effective at treating patients whose disease was not responding to previous treatment or had returned and who could not have a transplant.
Danish: Det blev i hovedstudiet påvist, at Polivy er effektivt til at behandle patienter, hvis sygdom ikke har reageret på tidligere behandling eller er vendt tilbage, og som ikke er egnede til transplantation.
English: Polivy contains the active substance polatuzumab vedotin.
Danish: Polivy indeholder det aktive stof polatuzumab vedotin.
English: Side effects reported with Polivy are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Polivy vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Polivy can affect the production of blood cells.
Danish: Polivy kan påvirke dannelsen af blodlegemer.
English: Patients with DLBCL have cancerous B cells, which are a type of white blood cell.
Danish: Patienter med DLBCL har maligne B-celler, der er en type hvide blodlegemer.
English: Patients are given paracetamol and an antihistamine medicine before receiving Polivy to reduce the risk of reactions to the infusion.
Danish: Patienterne får paracetamol og antihistamin før infusionen af Polivy for at reducere risikoen for infusionsrelaterede reaktioner.
English: Since Polivy has been given conditional authorisation, the company that markets Polivy will provide further data on its effects to confirm Polivy's safety and effectiveness when used in combination with other cancer medicines in patients with DLBCL.
Danish: Da Polivy har fået en betinget godkendelse, skal den virksomhed, der markedsfører Polivy, fremlægge yderligere data om dets virkning for at bekræfte lægemidlets sikkerhed og virkning ved brug i kombination med andre kræftlægemidler hos patienter med DLBCL.
English: What information is still awaited for Polivy?
Danish: Hvilke oplysninger afventes der stadig for Polivy?
English: The doctor may reduce or stop the dose of Polivy if the patient develops side effects affecting blood cells.
Danish: Lægen kan reducere dosen af Polivy eller stoppe behandlingen, hvis patienten udvikler bivirkninger, der påvirker blodlegemerne.
English: It is used in combination with two other medicines, bendamustine and rituximab.
Danish: Det anvendes i kombination med to andre lægemidler, bendamustin og rituximab.
English: What are the risks associated with Polivy?
Danish: Hvilke risici er der forbundet med Polivy?
English: The active substance in Polivy, polatuzumab vedotin, is made up of a monoclonal antibody (a type of protein) combined with a substance called monomethyl auristatin E (MMAE).
Danish: Det aktive stof i Polivy, polatuzumab vedotin, er fremstillet af monoklonalt antistof (en type protein) kombineret med et stof, der hedder monomethyl auristatin E (MMAE).
English: After 6 to 8 weeks of treatment, there were no signs of the cancer (complete response) in 40% of patients receiving Polivy plus rituximab and bendamustine compared with 18% of patients receiving rituximab and bendamustine alone.
Danish: Efter 6-8 ugers behandling var der ikke tegn på kræft (fuldstændigt respons) hos 40 % af de patienter, der fik Polivy + rituximab og bendamustin, sammenholdt med 18 % af de patienter, der fik rituximab og bendamustin alene.
English: The dose of Polivy depends on the patient's bodyweight and is given for 6 cycles.
Danish: Dosen af Polivy afhænger af patientens legemsvægt, og behandlingen gives over 6 serier.
English: Polivy can only be obtained with a prescription, and treatment must be given under the supervision of a healthcare professional experienced in the diagnosis and treatment of cancer.
Danish: Polivy fås kun på recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i diagnosticering og behandling af kræft.
English: Polivy is a cancer medicine used to treat adults with diffuse large B-cell lymphoma (DLBCL) whose cancer has returned or has stopped responding to other treatments and who cannot have a bonemarrow transplantation.
Danish: Polivy er et kræftlægemiddel, der anvendes til at behandle voksne patienter med diffust storcellet Bcelle-lymfom (DLBCL), hvis kræft er vendt tilbage eller ikke længere reagerer på andre behandlinger, og som ikke kan få en knoglemarvstransplantation.
English: For more information about using Polivy, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Polivy, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Serious side effects (which may affect up to 1 in 10 people) include febrile neutropenia (low white blood cell count with fever), fever, and pneumonia (infection of the lungs).
Danish: Alvorlige bivirkninger (der kan forekomme hos op til 1 ud af 10 patienter) omfatter febril neutropeni (lavt antal hvide blodlegemer med feber), feber og lungebetændelse.
English: For the full list of side effects and restrictions of Polivy, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Polivy fremgår af indlægssedlen.
English: It is given in 21-day cycles with rituximab and bendamustine.
Danish: Det gives i serier af 21 dage sammen med rituximab og bendamustin.
English: Half of the patients received Polivy added to the standard regimen of bendamustine plus rituximab whereas the other half received bendamustine plus rituximab alone.
Danish: Halvdelen af patienterne fik Polivy i tillæg til standardbehandling med bendamustin + rituximab, mens den anden halvdel fik bendamustin + rituximab alene.
English: The most common side effects with Polivy in combination with bendamustin and rituximab (which may affect more than 3 in 10 people) were anaemia (low red blood cell count), thrombocytopenia (low blood platelet count), neutropenia (low white blood cell count), tiredness, diarrhoea, nausea (feeling sick) and fever.
Danish: De hyppigste bivirkninger ved Polivy i kombination med bendamustin og rituximab (der kan forekomme hos mere end 3 ud af 10 patienter) er blodmangel (lavt antal røde blodlegemer), trombocytopeni (lavt antal blodplader), neutropeni (lavt antal hvide blodlegemer), træthed, diarré, kvalme og feber.
English: Polivy received a conditional marketing authorisation valid throughout the EU on 16 January 2020 Further information on Polivy can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/polivy.
Danish: Yderligere information om Polivy findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/polivy.
English: How is Polivy used?
Danish: Hvordan anvendes Polivy?
English: How does Polivy work?
Danish: Hvordan virker Polivy?
English: What benefits of Polivy have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Polivy?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Polivy 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 Polivy.
English: The monoclonal antibody attaches to a protein called CD79b on B cells, including cancerous B cells, and in doing so causes MMAE to be released inside them.
Danish: Det monoklonale antistof binder til proteinet CD79b på
English: This was confirmed in the fourth study.
Danish: Dette blev bekræftet i den fjerde undersøgelse.
English: This summary was last updated in 03-2009.
Danish: Dette sammendrag blev sidst ajourført i 03-2009.
English: The marketing authorisation was renewed on 14 February 2001 and on 14 February 2006.
Danish: Markedsføringstilladelsen blev fornyet den 14. februar 2001 og den 14. februar 2006.
English: It is available as white, round tablets (60 mg).
Danish: Det fås som hvide, runde tabletter (60 mg).
English: The marketing authorisation holder is Orion Corporation.
Danish: Indehaveren af markedsføringstilladelsen er Orion Corporation.
English: The recommended dose of Fareston is one tablet once a day.
Danish: Den anbefalede dosis af Fareston er en tablet én gang dagligt.
English: Other information about Fareston:
Danish: Andre oplysninger om Fareston:
English: ‘Metastatic' means that the cancer has spread to other parts of the body.
Danish: At kræften er ”metastatisk” vil sige, at den har bredt sig til andre dele af kroppen.
English: The effects of Fareston were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Fareston blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FARESTON EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) FARESTON EPAR - sammendrag for offentligheden
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fareston on 14 February 1996.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse for Fareston med gyldighed i hele Den Europæiske Union den 14. februar 1996.
English: It attaches to the receptors for oestrogen on the surface of cells, where its main effect is to block the effects of the hormone.
Danish: Det bindes til receptorerne for østrogen på cellernes overflade, hvor dets hovedvirkning er at blokere for hormonets virkninger.
English: Most types of breast cancer grow in response to the hormone oestrogen.
Danish: De fleste former for brystkræft vokser som reaktion på hormonet østrogen.
English: The main measures of effectiveness were response rate (the number of patients whose tumours responded to treatment), time to progression (the length of time until the disease got worse) and survival.
Danish: Det primære effektmål var responsraten (antallet af patienter, hvis tumorer reagerede på behandlingen), tiden indtil sygdomsforværring og overlevelsestiden.
English: Fareston is a medicine that contains the active substance toremifene.
Danish: Fareston er et lægemiddel, der indeholder det aktive stof toremifen.
English: The most common side effects with Fareston (seen in more than 1 patient in 10) are hot flushes and sweating.
Danish: De hyppigste bivirkninger ved Fareston (som ses hos flere end 1 ud af 10 patienter) er hedeture og svedtendens.
English: The active substance in Fareston, toremifene, is an anti-oestrogen.
Danish: Det aktive stof i Fareston, toremifen, er et antiøstrogen.
English: A list of these medicines is given in the Package Leaflet.
Danish: Listen over disse lægemidler fremgår af indlægssedlen.
English: The Committee recommended that Fareston be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Fareston.
English: Fareston must not be used in patients with ‘QT prolongation' (a disruption of the electrical activity of the heart), electrolyte disturbances (altered levels of salts in the blood) especially hypokalaemia (low potassium levels), bradycardia (a very slow heart rate), heart failure (an inability of the heart to pump enough blood to the rest of the body) or a history of symptomatic arrhythmias (abnormal heart rhythms), or in patients also taking other medicines that can cause QT prolongation.
Danish: Fareston må ikke anvendes til patienter med ‘QT-forlængelse' (en afbrydelse af den elektriske aktivitet i hjertet), elektrolytforstyrrelser (ændrede saltkoncentrationer i blodet), især hypokalæmi (lave kaliumkoncentrationer), bradykardi (en meget langsom hjerterytme), hjerteinsufficiens (hjertets manglende evne til at pumpe tilstrækkeligt med blod ud til resten af kroppen) eller tidligere symptomatisk arytmier (unormal hjerterytme) eller til patienter, som også får andre lægemidler, der kan forårsage QT-forlængelse..
English: It should be used with caution in patients who have problems with their liver.
Danish: Det bør anvendes med forsigtighed hos patienter med leversygdom.
English: The effects of Fareston were compared with those of tamoxifen (another anti-oestrogen used to treat breast cancer).
Danish: Virkningerne af Fareston blev sammenlignet med virkningerne af tamoxifen (et andet antiøstrogen, der anvendes til behandling af brystkræft).
English: Fareston is not recommended for patients with oestrogen-receptor-negative tumours (where the cancer cells do not have receptors for the hormone oestrogen on their surface).
Danish: Fareston anbefales ikke til patienter med østrogen-receptor negative tumorer (hvor kræftcellerne ikke har receptorer til hormonet østrogen på overfladen).
English: The full EPAR for Fareston can be found here.
Danish: Den fuldstændige for Fareston findes her.
English: As a result, the tumour cells are not stimulated to grow by oestrogen and the growth of the tumour is reduced.
Danish: Resultatet er, at østrogen ikke længere får svulstcellerne til at vokse, så svulstens vækst bremses.
English: The effectiveness of Fareston and tamoxifen were equivalent.
Danish: Fareston og tamoxifen havde samme virkning.
English: What is the risk associated with Fareston?
Danish: Hvilken risiko er der forbundet med Fareston?
English: For the full list of all side effects reported with Fareston, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Fareston fremgår af indlægssedlen.
English: Why has Fareston been approved?
Danish: Hvorfor blev Fareston godkendt?
English: Fareston should not be used in people who may be hypersensitive (allergic) to toremifene or any of the other ingredients.
Danish: Fareston bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for toremifen eller andre af indholdsstofferne.
English: Fareston is used to treat hormone-dependent metastatic breast cancer in women who have been through the menopause.
Danish: Fareston anvendes til behandling af hormonafhængig metastatisk brystkræft hos kvinder efter overgangsalderen.
English: Fareston has been studied in 1,869 postmenopausal women with metastatic breast cancer in four main studies.
Danish: Fareston blev undersøgt i fire hovedundersøgelser af 1 869 kvinder, der havde været igennem overgangsalderen og havde metastatisk brystkræft.
English: Therefore, the Committee decided that Fareston's benefits are greater than its risks for the first line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.
Danish: Udvalget fandt derfor, at fordelene ved Fareston opvejer risiciene til førstevalgsbehandling af hormonafhængig metastatisk brystkræft hos kvinder efter overgangsalderen.
English: What is Fareston?
Danish: Hvad er Fareston?
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits and risks of Fareston were comparable to those of tamoxifen in women with oestrogen-receptor-positive tumours.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Fareston til behandling af østrogen receptor positive tumorer svarer til tamoxifen hvad angår fordele og risici.
English: It must not be used on a long-term basis in patients who have endometrial hyperplasia (thickening of the lining of the womb) or severe liver problems.
Danish: Fareston må ikke anvendes i længere tid hos patienter med endometrisk hyperplasi (fortykket livmoderslimhinde) eller svære leverproblemer.
English: Looking at the results of the three largest main studies taken together, patients taking Fareston had similar response rates, times to progression and survival rates as the patients taking tamoxifen.
Danish: Resultaterne af de tre største hovedundersøgelser viste tilsammen, at Fareston og tamoxifen svarede til hinanden med hensyn til responsrate, tid til forværring og overlevelse.
English: What benefit has Fareston shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Fareston?
English: What is Fareston used for?
Danish: Hvad anvendes Fareston til?
English: How has Fareston been studied?
Danish: Hvordan blev Fareston undersøgt?
English: How is Fareston used?
Danish: Hvordan anvendes Fareston?
English: How does Fareston work?
Danish: Hvordan virker Fareston?
English: 12 July 2012
Danish: Den 12. juli 2012
English: In addition, no long-term safety data were provided, although treatment with Egrifta was expected to be long term.
Danish: Desuden forelå der ikke langsigtede sikkerhedsdata, selv om behandlingen med Egrifta forventedes at være langvarig.
English: What is Egrifta?
Danish: Hvad er Egrifta?
English: If you are in a compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i et program for anvendelse med særlig udleveringstilladelse og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
English: Withdrawal of the marketing authorisation application for Egrifta (tesamorelin)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Egrifta (tesamorelin)
English: Egrifta is a medicine that contains the active substance tesamorelin.
Danish: Egrifta er et lægemiddel, der indeholder det aktive stof tesamorelin.
English: What was Egrifta expected to be used for?
Danish: Hvad forventedes Egrifta anvendt til?