FrancophonIA/ELRC3.0 huggingface dataset:
English: o abnormal skin growth (skin neoplasm) o excessive hair growth o flushing, facial redness and pimples possibly with pus o other skin disorders o red, scaly and itchy skin inflammation (seborrhoeic dermatitis) o red, bumpy or blistering rash o skin cysts o skin tightness
Danish: o unromal hudvækst (hudneoplasme) o udtalt hårvækst o blussen, ansigtsrødmen og bumser, muligvis med betændelse o andre hudlidelser o rød, skallende og kløende hudbetændelse (seboroisk eksem) o rødt, nopret udslæt eller udslæt med blister o hudcyster o hudstramhed
English: (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
Danish: (hyppigheden kan ikke estimeres ud fra forhåndenværende data).
English: Rare (affects 1 to 10 users in 10,000)
Danish: Sjælden (påvirker 1 til 10 brugere ud af 10.000)
English: o dry skin o hair loss o inflammation around the hair shaft o itching o rash o redness o skin irritation and bumps caused by shaving o skin irritation o stinging, tingling or burning feeling on the skin
Danish: o tør hud o hårtab o betændelse omkring hårskaftet o kløe o udslæt o rødme o hudirritation og knopper forårsaget af barbering o hudirritation o stikkende, snurrende eller brændende fornemmelse i huden
English: o bumpy rash (papular rash) o cold sores o redness and irritation at the site where the cream is applied o eczema o inflammed, dry, cracked or numb lips o ingrowing hairs o pale areas on the skin o skin bleeding o skin boils o skin flushing o skin inflammation o sore skin o swelling of the mouth or face o unusual hair texture or hair growth
Danish: o nopret udslæt (papuløst udslæt) o forkølelsessår o rødme og irritation på stedet for påføring af cremen o eksem o betændte, tørre, revnede eller følelsesløse læber o indgroet hår o blege hudområder o hudblødning o hudbylder o hudrødmen o hudbetændelse o øm hud o hævelse af mund og ansigt o usædvanlig hårtekstur eller hårvækst
English: Improvement in the condition may be noticed within eight weeks of starting treatment.
Danish: Der kan ses forbedret tilstand indenfor 8 uger efter behandlingsstart.
English: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare
Danish: (påvirker 1 til 10 brugere ud af 100) ikke almindelig (påvirker 1 til 10 brugere ud af 1.000) sjælden
English: What you need to know before you use Vaniqa 3.
Danish: Det skal du vide, før du begynder at bruge Vaniqa Sådan skal du bruge Vaniqa Bivirkninger
English: Macrogol stearate;
Danish: Makrogolstearat;
English: Uncommon (affects 1 to 10 users in 1,000)
Danish: Ikke almindelig (påvirker 1 til 10 brugere ud af 1.000)
English: Macrogol cetostearyl ether;
Danish: Macrogolcetostearylæter;
English: Of those with no acne at baseline, similar percentages (14%) reported acne following treatment with Vaniqa or vehicle.
Danish: Af de patienter, der ikke havde akne ved start af behandlingen, fik 14% af de patienter, der var behandlede med Vaniqa, og 14% af de patienter, der var behandlet med vehikel akne.
English: Cutaneous use
Danish: Kutan anvendelse.
English: If you use more Vaniqa than you should
Danish: Hvis du har brugt for meget Vaniqa
English: Eflornithine
Danish: Amning
English: Batch
Danish: TUBER
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Vaniqa, skal du henvende dig til den lokale repræsentant:
English: This is called ‘myeloablation'.
Danish: Dette kaldes "myeloablation".
English: The European Commission granted a marketing authorisation valid throughout the EU for Busilvex on 9 July 2003.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Busilvex den 9. juli 2003.
English: This is a summary of the European public assessment report (EPAR) for Busilvex.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Busilvex.
English: The full EPAR for Busilvex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Busilvex findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: There were two main studies involving 103 adults and one involving 55 children.
Danish: Der er udført to kliniske hovedundersøgelser hos 103 voksne og en undersøgelse hos 55 børn.
English: It contains the active substance busulfan.
Danish: Det indeholder det aktive stof busulfan.
English: Busilvex must not be used in women who are pregnant.
Danish: Busilvex må ikke gives til kvinder, der er gravide.
English: Busilvex can affect fertility in both sexes.
Danish: Busilvex kan påvirke frugtbarheden hos begge køn.
English: For more information about treatment with Busilvex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Busilvex, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
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 Busilvex.
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, hvordan Busilvex skal anvendes.
English: This type of transplant is used in patients who need to replace their blood-making cells, because they have a blood disorder (such as a rare type of anaemia) or a cancer of the blood.
Danish: Denne type transplantat anvendes til patienter, hos hvem man er nødt til at udskifte de bloddannende celler, fordi patienten har en blodsygdom (f.eks. en sjælden form for blodmangel) eller blodkræft.
English: This means that they kill cells, especially cells that develop rapidly, such as cancer or progenitor (or ‘stem') cells (cells that make other types of cell).
Danish: Dette betyder, at de dræber celler, især hurtigtvoksende celler som kræftceller og ”stamceller” (celler der danner andre former for celler).
English: Because of this, female patients should not become pregnant during treatment and for up to six months afterwards, and male patients are advised not to father a child during and for up to six months after treatment with Busilvex.
Danish: Kvindelige patienter bør derfor undgå at blive gravide under behandlingen og indtil seks måneder efter behandlingen, og det tilrådes mandlige patienter at undgå at avle børn under behandlingen og indtil seks måneder efter behandlingen med Busilvex.
English: Busilvex should be used by a doctor who has experience in treatments given before transplantation.
Danish: Busilvex bør kun anvendes af læger, som har erfaring med behandlinger, der gives inden transplantation.
English: Each infusion lasts for two hours and it is given to the patient every six hours on four consecutive days before treatment with cyclophosphamide or melphalan and the transplant.
Danish: Hver infusion varer i to timer og gives til patienten hver sjette time i fire på hinanden følgende dage inden behandlingen med cyclophosphamid eller melphalan og transplantation.
English: The active substance in Busilvex, busulfan, belongs to a group of medicines called ‘alkylating agents'.
Danish: Det aktive stof i Busilvex, busulfan, tilhører en gruppe lægemidler, der kaldes alkylerende midler.
English: Other information about Busilvex
Danish: Andre oplysninger om Busilvex
English: The data from the published studies showed that Busilvex in combination with fludarabine was effective as a ‘reduced-intensity' conditioning treatment, with complete engraftment achieved in 80 to 100% of patients.
Danish: Dataene fra de offentliggjorte undersøgelser viste, at Busilvex i kombination med fludarabin var effektiv som konditionerende behandling med »reduceret intensitet«, idet der blev opnået fuldstændig anslag af transplantatet hos 80 ud af 100 % af patienterne.
English: Since Busilvex in combination with fludarabine has been used in clinical practice for many years, data from 7 studies (involving 731 patients) which looked at the effectiveness of Busilvex and fludarabine as ‘reduced-intensity' conditioning treatment were presented.
Danish: Da Busilvex i kombination med fludarabin er blevet anvendt i klinisk praksis i mange år, blev der fremlagt data fra 7 undersøgelser (med 731 patienter), hvori der blev set nærmere på virkningen af Busilvex og fludarabin som konditionerende behandling med »reduceret intensitet«.
English: Busilvex is used in adults and children as part of a ‘conditioning' (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells).
Danish: Busilvex anvendes til voksne og børn som en del af en ”konditionerende” (forberedende) behandling før transplantation af bloddannende progenitorceller (stamceller, der danner røde blodlegemer).
English: Apart from the decrease in blood cell counts, which is the intended effect of the medicine, the most serious side effects of Busilvex are infection, liver disorders including blocking of a liver vein, graft versus host disease (when the transplanted cells attack the body) and respiratory (lung) disorders.
Danish: Ud over faldet i antal blodceller, som er lægemidlets tilsigtede virkning, er de alvorligste bivirkninger af Busilvex infektioner, leversygdom, herunder tillukning af en levervene, transplantat-mod-vært-reaktion (når de transplanterede celler angriber kroppen) og luftvejssygdomme.
English: Breast-feeding should be stopped when treatment with Busilvex is started.
Danish: Amning bør ophøre, når behandlingen med Busilvex påbegyndes.
English: Busulfan is used before transplantation to destroy abnormal cells and the patient's existing haematopoietic progenitor cells.
Danish: Busulfan anvendes inden transplantation til at dræbe unormale celler og patientens eksisterende bloddannende progenitorceller.
English: The Committee decided that Busilvex's benefits are greater than its risks in these settings and recommended that Busilvex be given marketing authorisation.
Danish: Udvalget besluttede, at fordelene ved Busilvex opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Busilvex.
English: This helps the transplanted cells to ‘engraft' (when they start to grow and produce normal blood cells).
Danish: Dette hjælper de transplanterede celler til at "slå an", dvs. til at begynde at vokse og producere normale blodceller.
English: The main measures of effectiveness were the number of patients with myeloablation and ‘engraftment' (the time for the transplanted stem cells to begin growing and for white blood cells to return to higher levels).
Danish: Hovedmålene for lægemidlets virkning var antallet af patienter med myeloablation og anslag af transplantat (den tid, det tog, før de transplanterede stamceller begyndte at vokse, og før antallet af hvide blodlegemer igen var tilbage på et højere niveau).
English: When Busilvex was given in combination with cyclophosphamide or melphalan, all adults and children achieved myeloablation.
Danish: Når Busilvex blev givet i kombination med cyclophosphamid eller melphalan, opnåede alle voksne og børn myeloablation.
English: Engraftment was obtained in 13 days in adults and 21 days in children with ‘allotransplantation' (when the patient receives cells from a donor).
Danish: Anslag af transplantatet opnåedes efter gennemsnitligt 13 dage hos voksne og 21 dage hos børn, når der var tale om allotransplantation (dvs. når patienten fik celler fra en donor).
English: Busilvex in combination with cyclophosphamide or melphalan has been studied in patients, mainly with blood cancer, who needed transplantation of haematopoietic progenitor cells.
Danish: Busilvex i kombination med cyclophosphamid eller melphalan er blevet undersøgt hos patienter, hovedsagelig med blodkræft, som havde behov for transplantation af bloddannende progenitorceller.
English: On average, engraftment was reached in 10 days in adults and 11 days in children with ‘autotransplantation' (when the patient receives their own cells, harvested and stored before the transplant).
Danish: Anslag af transplantatet opnåedes efter gennemsnitligt 10 dage hos voksne og 11 dage hos børn, når der var tale om autotransplantation (dvs. når patienten fik sine egne celler, som var indhøstet og opbevaret inden behandlingen).
English: Busilvex is a concentrate to be made up into a solution for infusion (drip into a vein).
Danish: Busilvex er et koncentrat, der omdannes til en opløsning til infusion (dråbetilførsel i en vene).
English: What is the risk associated with Busilvex?
Danish: Hvilken risiko er der forbundet med Busilvex?
English: Cyclophosphamide, melphalan or fludarabine are used to suppress the immune system, so that the body's natural defences are decreased.
Danish: Derefter behandles patienten med cyclophosphamid, melphalan eller fludarabin for at dæmpe immunsystemet, så kroppens naturlige forsvar nedsættes.
English: When used in combination with cyclophosphamide or melphalan the recommended dose of Busilvex in adults is 0.8 mg per kilogram body weight.
Danish: Når det anvendes i kombination med cyclophosphamid eller melphalan er den anbefalede dosis af Busilvex til voksne 0,8 mg pr. kg legemsvægt.
English: For the full list of all side effects and restrictions with Busilvex, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Busilvex fremgår af indlægssedlen.
English: For a conventional conditioning treatment, Busilvex is given before treatment with a second medicine, cyclophosphamide, in adults, and either cyclophosphamide or an alternative medicine, melphalan, in children.
Danish: I forbindelse med konventionel konditionerende behandling gives Busilvex inden behandlingen sammen med et andet lægemiddel, cyclophosphamid, til voksne, og enten cyclophosphamid eller et alternativt lægemiddel, melphalan, til børn.
English: Why has Busilvex been approved?
Danish: Hvorfor blev Busilvex godkendt?
English: In adult patients who are eligible for a ‘reduced-intensity' conditioning regimen, Busilvex is given right after treatment with another medicine, fludarabine.
Danish: Til voksne, der egner sig til en konditionerende behandling med reduceret intensitet, gives Busilvex lige efter behandlingen sammenmed et andet lægemiddel, fludarabin.
English: What is Busilvex?
Danish: Hvad er Busilvex?
English: When used in combination with fludarabine, the recommended dose of Busilvex is 3.2 mg per kilogram given once a day as a three-hour infusion immediately after fludarabine, for 2 or 3 consecutive days.
Danish: en gang dagligt som en tre timers infusion umiddelbart efter fludarabin i 2- 3 på hinanden følgende dage.
English: What benefit has Busilvex shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Busilvex?
English: What is Busilvex used for?
Danish: Hvad anvendes Busilvex til?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom of Busilvex varies between 0.8 and 1.2 mg per kilogram depending on the weight of the child. Busilvex is given as a central intravenous infusion (drip into a central vein in the chest).
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The CHMP concluded that the effectiveness of Busilvex in combination with cyclophosphamide and melphalan for conventional conditioning, and with fludarabine for reduced-intensity conditioning had been shown; Busilvex also provides an alternative to busulfan tablets, which have disadvantages such as the large number of tablets that need to be taken.
Danish: CHMP konkluderede, at virkningen af Busilvex i kombination med cyclophosphamid og melphalan til konventionel konditionering og sammen med fludarabin til konditionering med reduceret intensitet er påvist.
English: How has Busilvex been studied?
Danish: Hvordan blev Busilvex undersøgt?
English: How is Busilvex used?
Danish: Hvordan anvendes Busilvex?
English: How does Busilvex work?
Danish: Hvordan virker Busilvex?
English: Before receiving Busilvex, patients are given anticonvulsive medicines (to prevent seizures) and anti-emetic medicines (to prevent vomiting).
Danish: Inden Busilvex gives, får patienten et krampestillende lægemiddel og et middel mod opkastninger.
English: These substances are ‘cytotoxic'.
Danish: Disse stoffer hæmmer cellers vækst.
English: Further information on Pifeltro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pifeltro.
Danish: Yderligere information om Pifeltro findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/pifeltro.
English: Other information about Pifeltro
Danish: Andre oplysninger om Pifeltro
English: Pifeltro (doravirine)
Danish: Pifeltro (doravirin)
English: As for all medicines, data on the use of Pifeltro are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Pifeltro løbende overvåget.
English: Pifeltro is available as tablets (100 mg) and can only be obtained with a prescription.
Danish: Pifeltro fås som tabletter (100 mg) og udleveres kun efter recept.
English: For more information about using Pifeltro, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Pifeltro, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: What measures are being taken to ensure the safe and effective use of Pifeltro?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pifeltro?
English: Pifeltro must not be used with certain medicines that may reduce its effectiveness.
Danish: Pifeltro må ikke anvendes sammen med visse lægemidler, der kan gøre det mindre effektivt.
English: Side effects reported with Pifeltro are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Pifeltro vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The European Medicines Agency therefore decided that Pifeltro's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Pifeltro opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: In addition, Pifeltro's side effects are mostly mild.
Danish: Derudover er bivirkningerne ved Pifeltro for det meste lette.
English: An overview of Pifeltro and why it is authorised in the EU
Danish: En oversigt over Pifeltro, og hvorfor det er godkendt i EU
English: Pifeltro is used together with other antiviral medicines.
Danish: Pifiltro anvendes sammen med andre antivirale lægemidler.
English: Pifeltro contains the active substance doravirine.
Danish: Pifeltro indeholder det aktive stof doravirin.
English: What is Pifeltro and what is it used for?
Danish: Hvad er Pifeltro, og hvad anvendes det til?
English: Doravirine blocks the activity of reverse transcriptase, an enzyme that allows HIV to reproduce itself in the cells it has infected.
Danish: Doravirin blokerer aktiviteten af revers transkriptase, som er et enzym, der gør det muligt for hiv at formere sig i de celler, det har inficeret.
English: The most common side effects with Pifeltro (which may affect up to 1 in 10 people) are nausea (feeling sick) and headache.
Danish: De hyppigste bivirkninger ved Pifeltro (som kan forekomme hos op til 1 ud af 10 personer) er kvalme og hovedpine.
English: What are the risks associated with Pifeltro?
Danish: Hvilke risici er der forbundet med Pifeltro?
English: Pifeltro (doravirine) EMA/821744/2018
Danish: Pifeltro (doravirin) EMA/661893/2018
English: Why is Pifeltro authorised in the EU?
Danish: Hvorfor blev Pifeltro godkendt i EU?
English: Pifeltro is an antiviral medicine used to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Pifeltro er et antiviralt lægemiddel til behandling af voksne, som er smittet med humant immundefektvirus type 1 (hiv-1), et virus, som forårsager erhvervet immundefektsyndrom (aids).
English: The active substance in Pifeltro, doravirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Danish: Det aktive stof i Pifeltro, doravirin, er en non-nukleosid revers transkriptasehæmmer (NNRTI).
English: Pifeltro helps keep the amount of HIV in the blood at a low level.
Danish: Pifeltro medvirker til at holde indholdet af hiv i blodet nede.
English: The medicine is not suitable for patients who are infected with HIV that is resistant to medicines in the same class as Pifeltro (non-nucleoside reverse transcriptase inhibitors or NNRTIs).
Danish: Lægemidlet er ikke egnet til patienter, der er inficeret med hiv, som er resistent over for lægemidler i samme klasse som Pifeltro (non-nukleoside reverse transkriptasehæmmere eller NNRTI'er).
English: For the full list of side effects and restrictions with Pifeltro, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Pifeltro fremgår af indlægssedlen.
English: It does not cure HIV infection or AIDS but, when used in combination with other antivirals, it holds off the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Det helbreder ikke hivinfektion eller aids, men sinker den skade på immunsystemet og udviklingen af de infektioner og sygdomme, der er forbundet med aids, når det anvendes i kombination med andre antivirale lægemidler.
English: In a second study with 728 patients, 84% of patients treated with Pifeltro in combination with tenofovir disoproxil and lamivudine had undetectable HIV levels by 48 weeks compared with 80% of patients given a combination of efavirenz, tenofovir disoproxil and emtricitabine.
Danish: I et andet studie med 728 patienter kunne der hos 84 % af de patienter, der blev behandlet med Pifeltro sammen med tenofovirdisoproxil og lamivudin, ikke påvises hiv efter 48 uger sammenlignet med 80 % hos patienter, der fik en kombination af efavirenz, tenofovirdisoproxil og emtricitabin.
English: This compares with 79% of patients taking standard combination of darunavir plus ritonavir (together with either emtricitabine and tenofovir disoproxil or abacavir and lamivudine).
Danish: Det samme er tilfældet for 79 % af de patienter, der tager en standardkombination af darunavir plus ritonavir (sammen med enten emtricitabin og tenofovirdisoproxil eller abacavir og lamivudin).
English: In a study of 766 patients, 83% of patients taking Pifeltro (together with either emtricitabine and tenofovir disoproxil or abacavir and lamivudine) had undetectable levels of HIV in their blood (fewer than 40 copies/ml) after 48 weeks of treatment.
Danish: I et studie med 766 patienter kunne der hos 83 % af de patienter, der tog Pifeltro (sammen med enten emtricitabin og tenofovirdisoproxil eller abacavir og lamivudin), ikke påvises hiv i blodet (færre end 40 kopier/ml) efter 48 ugers behandling.
English: Pifeltro used in combination with other antivirals is as effective as standard HIV combination treatments at keeping HIV infection under control.
Danish: Pifeltro anvendt sammen med andre antivirale lægemidler er lige så effektiv som standardkombinationsbehandlinger mod hiv til at holde hivinfektion nede.
English: Studies showed that Pifeltro taken with other antivirals was as effective at keeping HIV infection under control as standard HIV combination treatments.
Danish: Studier viste, at Pifeltro taget sammen med andre antivirale lægemidler var lige så effektivt til at holde hivinfektion nede som standardkombinationsbehandlinger mod hiv.
English: How is Pifeltro used?
Danish: Hvordan anvendes Pifeltro?
English: What benefits of Pifeltro have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Pifeltro?
English: How does Pifeltro work?
Danish: Hvordan virker Pifeltro?