FrancophonIA/ELRC3.0 huggingface dataset:
English: A diagnosis of POTS cannot solely rely on these criteria; other symptoms (e.g. syncope, fatigue, headaches, lightheadedness, diaphoresis, tremor, palpitations, exercise intolerance, near syncope upon standing upright) vary across patients and are otherwise non-specific.
Danish: Andre symptomer (fx synkope, træthed, hovedpine, svimmelhed, svedtendens, tremor, palpitationer, manglende evne til fysisk aktivitet, synkopelignende anfald, når man rejser sig) er forskellige for forskellige patienter og i øvrigt uspecifikke.
English: Taking into account the totality of the available information the PRAC concluded that the evidence does not support that HPV vaccines (Cervarix, Gardasil, Gardasil 9, Silgard) cause CRPS or POTS.
Danish: Ud fra alle de foreliggende oplysninger konkluderede PRAC, at evidensen ikke støtter, at HPV-vacciner (Cervarix, Gardasil, Gardasil 9, Silgard) er årsag til CRPS eller POTS.
English: The Committee, having considered all the information available, concluded that the evidence does not support a causal association between HPV vaccination and CRPS and/or POTS.
Danish: konkluderede udvalget efter at have gennemgået alle de foreliggende oplysninger, at evidensen ikke underbygger en årsagssammenhæng mellem HPV-vaccination og CRPS og/eller POTS.
English: It was agreed that employing broad search strategies to identify possible cases of CRPS and POTS and ongoing comparison of reporting rates against available information on the known epidemiology of CRPS and POTS is important.
Danish: Der var enighed om vigtigheden af brede søgestrategier til at identificere mulige tilfælde af CRPS og POTS, og af løbende sammenholdelse af indberetningsfrekvensen med de foreliggende oplysninger om den kendte epidemiologi af CRPS og POTS.
English: The results of a large published study2 showed no link between HPV vaccine and CFS.
Danish: Resultaterne af en stor publiceret undersøgelse2 viste ingen sammenhæng mellem HPV-vaccine og CFS.
English: • The PRAC considered the totality of the data submitted with regard to a potential association between HPV vaccination and the occurrence of Complex regional pain syndrome (CRPS) and Postural orthostatic tachycardia syndrome (POTS).
Danish: • PRAC gennemgik samtlige forelagte data vedrørende en mulig sammenhæng mellem HPVvaccination og forekomsten af refleksdystrofi (CRPS) og postural ortostatisk takykardisyndrom (POTS).
English: The CHMP, as a consequence, considers that the benefit-risk balance of HPV vaccines (Cervarix, Gardasil, Gardasil 9 and Silgard) remains favourable and therefore recommends the maintenance of the marketing authorisations.
Danish: CHMP fastslog som konsekvens heraf, at benefit/risk-forholdet for HPV-vacciner (Cervarix, Gardasil, Gardasil 9 og Silgard) fortsat er positivt, og anbefaler derfor opretholdelse af markedsføringstilladelserne.
English: The incidence of POTS in the Gardasil/Silgard and Gardasil 9 clinical trials was less than 1 case per 10,000 person-years and comparable in the Gardasil/Silgard/Gardasil 9 and corresponding placebo cohorts.
Danish: Incidensen af POTS i de kliniske Gardasil/Silgard- og Gardasil 9-forsøg var mindre end ét tilfælde pr. 10 000 personår og sammenlignelig i Gardasil/Silgard- og Gardasil 9-gruppen og de tilsvarende placebogrupper.
English: The PRAC confirmed that the benefit-risk balance of the HPV vaccines (Cervarix, Gardasil, Gardasil 9 and Silgard) remains favourable and recommends the maintenance of the marketing authorisations.
Danish: PRAC fastslog, at benefit/risk-forholdet for HPV-vacciner (Cervarix, Gardasil, Gardasil 9 og Silgard) fortsat er positivt og anbefaler opretholdelse af markedsføringstilladelserne.
English: Furthermore, the detailed review of the reports did not show a consistent pattern regarding time-toonset (TTO) following vaccination or clinical characteristics.
Danish: Desuden viste den detaljerede gennemgang af indberetningerne intet sammenhængende mønster i tid til indsætten efter vaccination, eller i kliniske kendetegn.
English: Overall, the comparisons of observed versus expected number of spontaneous reports do not suggest an increased occurrence of CRPS in relation to the HPV vaccines.
Danish: Sammenholdelse af observerede kontra forventede antal spontane indberetninger tyder overordnet ikke på øget forekomst af CRPS i forbindelse med HPV-vaccinerne.
English: Furthermore, the detailed review of the reports of CRPS did not show a consistent pattern regarding time-to-onset (TTO) following vaccination or clinical characteristics.
Danish: Desuden viste den detaljerede gennemgang af indberetningerne om CRPS intet sammenhængende mønster i tid til indsætten efter vaccination eller kliniske kendetegn.
English: The incidence of CRPS in the Gardasil/Silgard and Gardasil 9 clinical trials was less than 1 case per 10,000 person-years and comparable in the Gardasil/Silgard and Gardasil 9 and corresponding placebo cohorts.
Danish: Incidensen af CRPS i de kliniske forsøg med Gardasil/Silgard og Gardasil 9 var mindre end ét tilfælde per 10 000 personår og sammenlignelig med incidensen i de tilsvarende placebogrupper.
English: general population around 150 girls and young women per million aged 10 to 19 years may develop CRPS each year, and at least 150 girls and young women per million may develop POTS each year.
Danish: I de foreliggende skøn anslås det imidlertid, at CRPS årligt udvikles hos omkring 150 piger og unge kvinder per million i alderen 10-19 år i den almindelige befolkning, og at mindst 150 piger og kvinder om året udvikler POTS.
English: Overall, available data do not provide support for a causal relation between HPV vaccines and POTS.
Danish: Overordnet støtter de foreliggende data ikke en kausal sammenhæng mellem HPV-vacciner og POTS.
English: Overall, available data do not provide support for a causal association between HPV vaccines and CRPS.
Danish: Overordnet støtter de foreliggende data ikke en kausal sammenhæng mellem HPV-vacciner og CRPS.
English: The PRAC therefore considered the results of a large published study which showed no link between HPV vaccine and CFS, as relevant for the current review.
Danish: En stor publiceret undersøgelse, der ikke viste sammenhæng mellem HPV-vaccine og CFS, blev derfor fundet relevant for denne gennemgang af PRAC
English: POTS is a systemic syndrome which has been known for a long time under different names and is still poorly understood.
Danish: POTS er et systemisk syndrom, som har været kendt i lang tid under forskellige navne, og som der stadig savnes indsigt i. De foreliggende skøn peger på, at mindst 150 piger og unge kvinder per million kan udvikle POTS per år.
English: Lenvima received a marketing authorisation valid throughout the EU on 28 May 2015.
Danish: Lenvima fik en markedsføringstilladelse med gyldighed i hele EU den 28. maj 2015.
English: Further information on Lenvima can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Lenvima findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The medicine is available as capsules (4 mg and 10 mg).
Danish: Lægemidlet fås som kapsler (4 mg og 10 mg).
English: Treatment is continued as long as the patient continues to benefit from it without too many side effects.
Danish: Behandlingen fortsætter, så længe patienten har fordel af den uden for mange bivirkninger.
English: What is Lenvima and what is it used for?
Danish: Hvad er Lenvima, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Lenvima?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Lenvima?
English: As for all medicines, data on the use of Lenvima are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Lenvima løbende overvåget.
English: Other information about Lenvima
Danish: Andre oplysninger om Lenvima
English: An overview of Lenvima and why it is authorised in the EU
Danish: En oversigt over Lenvima og hvorfor det er godkendt i EU
English: Why is Lenvima authorised in the EU?
Danish: Hvorfor blev Lenvima godkendt i EU?
English: Lenvima is used when the cancer has progressed or spread locally or to other parts of the body, and does not respond to treatment with radioactive iodine.
Danish: Lenvima anvendes, når kræften er fremskreden eller har bredt sig lokalt eller til andre dele af kroppen og ikke reagerer på behandling med radioaktivt iod.
English: By blocking these enzymes, lenvatinib can block the formation of new blood vessels and hence cut off the blood supply that keeps cancer cells growing, and reduce their growth.
Danish: Ved at blokere disse enzymer kan lenvatinib standse dannelsen af nye blodkar og derved afskære kræftcellernes blodforsyning, der gør det muligt for dem at blive ved med at vokse.
English: Lenvima must not be taken by breastfeeding women.
Danish: Lenvima må ikke anvendes af kvinder, der ammer.
English: The main measure of effectiveness was how long the patients lived without their disease getting worse: in the patients taking Lenvima this was an average of 18.3 months, compared with 3.6 months in those taking placebo.
Danish: Virkningen blev hovedsagelig målt på, hvor længe patienterne overlevede uden forværring af sygdommen: For de patienter, der fik Lenvima, var dette i gennemsnit 18,3 måneder sammenholdt med 3,6 måneder for dem, der fik placebo.
English: Lenvima contains the active substance lenvatinib.
Danish: Lenvima indeholder det aktive stof lenvatinib.
English: Side effects reported with Lenvima are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Lenvima vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: For treatment of hepatocellular carcinoma, the recommended daily dose is either 8 or 12 mg depending on bodyweight.
Danish: Til behandling af hepatocellulært karcinom er den anbefalede daglige dosis enten 8 eller 12 mg, afhængigt af legemsvægten.
English: For more information about using Lenvima, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Lenvima, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency decided that Lenvima'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 Lenvima opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Lenvima can only be obtained with a prescription and treatment must be started and supervised by a doctor who is experienced in using cancer medicines.
Danish: Lenvima udleveres kun efter recept, og behandlingen skal indledes og overvåges af en læge med erfaring i brug af kræftmedicin.
English: To manage side effects, the doctor may decide to reduce the dose or stop treatment temporarily.
Danish: Hvis der opstår bivirkninger, kan lægen beslutte at nedsætte dosis eller midlertidigt standse behandlingen.
English: Patients given Lenvima lived on average 13.6 months compared with 12.3 months in patients on sorafenib.
Danish: Patienter, der fik Lenvima, levede i gennemsnit 13,6 måneder sammenholdt med 12,3 måneder for dem, der fik sorafenib.
English: Lenvima is a cancer medicine used on its own to treat:
Danish: Lenvima er et kræftlægemiddel, der anvendes som enebehandling til:
English: The active substance in Lenvima, lenvatinib, is a ‘tyrosine-kinase inhibitor'.
Danish: Det aktive stof i Lenvima, lenvatinib, er en "tyrosinkinasehæmmer".
English: Regarding safety, the Agency considered that the majority of adverse effects with Lenvima can be adequately managed by reducing the dose or temporarily interrupting treatment.
Danish: Hvad sikkerheden angår, fandt agenturet, at størstedelen af bivirkningerne ved Lenvima kan håndteres tilfredsstillende ved at nedsætte dosis eller holde pause i behandlingen.
English: What are the risks associated with Lenvima?
Danish: Hvilke risici er der forbundet med Lenvima?
English: The most important serious side effects are kidney failure and impairment; problems with the heart and circulation such as heart failure, blood clots in the arteries leading to stroke or heart attack, bleeding in the brain, a syndrome known as ‘posterior reversible encephalopathy syndrome' characterised by headache, confusion, fits and loss of vision, liver failure, hepatic encephalopathy (brain damage due to liver failure), stroke and heart attack.
Danish: De vigtigste alvorlige bivirkninger er nyresvigt og nedsat nyrefunktion, hjerte- og kredsløbsproblemer såsom hjertesvigt, blodpropper i arterierne med deraf følgende slagtilfælde eller hjerteanfald, blødning i hjernen og et sygdomskompleks med hovedpine, forvirring, krampeanfald og synsnedsættelse (posteriort reversibelt encefalopatisyndrom), leversvigt, hjerneskade som følge af leversvigt (hepatisk encefalopati), slagtilfælde og hjerteanfald.
English: For treatment of differentiated thyroid carcinoma, the recommended dose is 24 mg taken once a day at approximately the same time every day.
Danish: Til differentieret skjoldbruskkirtelkræft er den anbefalede dosis 24 mg én gang dagligt, der tages på omtrent samme klokkeslæt hver dag.
English: Lenvima has been shown to be at least as effective as the cancer medicine sorafenib at prolonging the time patients lived in one main study.
Danish: Lenvima er påvist at være mindst lige så effektivt som kræftlægemidlet sorafenib til at forlænge patienternes overlevelse i ét hovedstudie.
English: The most common side effects with Lenvima (which may affect more than 3 in 10 people) are hypertension (high blood pressure), diarrhoea, decreased appetite and weight, tiredness, nausea (feeling sick), proteinuria (protein in the urine), stomatitis (inflammation of the lining of the mouth), vomiting, dysphonia (speech disturbances), headache and palmar-plantar erythrodysaesthesia syndrome (PPE - rash and numbness on the palms and soles).
Danish: De hyppigste bivirkninger ved Lenvima (som kan forekomme hos mere end 3 ud af 10 personer) er forhøjet blodtryk, diarré, nedsat appetit, vægttab, træthed, kvalme, æggehvidestof i urinen (proteinuri), inflammation af mundslimhinden (stomatitis), opkastning, taleforstyrrelser (dysfoni), hovedpine samt udslæt og følelsesløshed i håndflader og fodsåler (palmart-plantart erytrodysæstesisyndrom (PPE)).
English: This means that it blocks the activity of enzymes known as tyrosine kinases.
Danish: Det vil sige, at det blokerer enzymer af typen tyrosinkinase.
English: The study involved 392 adult patients with differentiated thyroid carcinoma that had shown signs of progression in the previous year and did not respond to treatment with radioactive iodine.
Danish: I studiet deltog 392 voksne patienter med differentieret skjoldbruskkirtelkræft, der havde vist tegn på at være fremskridende i det foregående år, og hos hvem behandling med radioaktivt iod havde ikke virket.
English: In patients with advanced hepatocellular carcinoma who have a poor prognosis and few treatment options, Lenvima was as effective as sorafenib in prolonging their life.
Danish: Hos patienter med fremskredent hepatocellulært karcinom (som har dårlige udsigter og få behandlingsmuligheder) var Lenvima lige så effektivt som sorafenib til at forlænge overlevelsen.
English: • adults with hepatocellular carcinoma (a type of liver cancer) who did not previously receive a cancer medicine by mouth or by injection and whose cancer is advanced or cannot be removed by surgery.
Danish: • voksne, som har leverkræft af typen hepatocellulært karcinom og ikke tidligere har fået et kræftlægemiddel, der tages gennem munden eller ved injektion, og hos hvem kræften er fremskreden eller ikke kan fjernes ved operation.
English: • adults with differentiated thyroid carcinoma, a type of cancer originating from the follicular cells of the thyroid gland.
Danish: • voksne med differentieret skjoldbruskkirtelkræft (thyroideakarcinom), som er en kræfttype, der udgår fra skjoldbruskkirtlens kirtelceller (follikulære celler).
English: Differentiated thyroid carcinoma
Danish: Differentieret thyroideakarcinom
English: In patients with differentiated thyroid carcinoma, the medicine showed a clinically relevant improvement in the time patients lived without their disease getting worse.
Danish: Hos patienter med differentieret skjoldbruskkirtelkræft bevirkede lægemidlet en klinisk relevant forlængelse af den tid, patienterne levede uden forværring af sygdommen.
English: The study involved 954 patients with hepatocellular carcinoma who had not previously been treated for their cancer and whose cancer could not be removed by surgery.
Danish: Studiet omfattede 954 patienter, som ikke tidligere var blevet behandlet, og hvis kræft ikke kunne fjernes ved operation.
English: What benefits of Lenvima have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Lenvima?
English: How is Lenvima used?
Danish: Hvordan anvendes Lenvima?
English: Lenvima has been shown to be more effective than placebo (a dummy treatment) at slowing down disease progression in one main study.
Danish: Et hovedstudie viser, at Lenvima er mere effektivt end virkningsløs behandling (placebo) til at forhale sygdommens fremskriden.
English: For the full list of side effects with Lenvima, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Lenvima fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lenvima 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 Lenvima.
English: These enzymes can be found in certain receptors (such as VEGF, FGFR and RET receptors) in cancer cells, where they activate several processes including cell division and the growth of new blood vessels.
Danish: Disse enzymer findes i visse receptorer (såsom VEGF-, FGFR- og RETreceptorer) i kræftceller.
English: How does Lenvima work?
Danish: Hvordan virker Lenvima?
English: If not, you can do it easily yourself.
Danish: Hvis ikke, kan du let tilberede den selv.
English: • if you or your child are repeatedly sick, or
Danish: • hvis du eller dit barn gentagne gange bliver syg
English: You will not need to prepare it again unless you start a new bottle.
Danish: Du har ikke brug for at tilberede den igen, undtagen du skal bruge en ny flaske.
English: Imprints are blue.
Danish: Påtrykningerne er blå.
English: You may drink and eat something after taking the medicine.
Danish: Du må gerne drikke eller spise noget efter at have taget medicinen.
English: • Give the medicine into the mouth
Danish: • Giv medicinen i munden
English: Shake the bottle well for 15 seconds.
Danish: Ryst flasken godt i 15 sekunder.
English: The contribution of Tamiflu to those events is unknown.
Danish: Tamiflus bidrag til disse hændelser er ukendt.
English: * This table is not intended to contain all possible weights for this population.
Danish: *Denne tabel indeholder ikke alle vægtmuligheder hos denne population.
English: Your pharmacist may have prepared the medicine for you when you collected your prescription.
Danish: Apoteket har måske tilberedt medicinen til dig, når du henter din medicin.
English: In 2008, H275Y was found in > 99 % of circulating H1N1 influenza isolates in Europe.
Danish: I 2008 blev H275Y fundet i > 99 % af de cirkulerende H1N1-influenza-isolater i Europa.
English: Make sure the medicine is swallowed.
Danish: Vær sikker på, at medicinen synkes.
English: The mixture must be swallowed immediately after its preparation.
Danish: Blandingen skal sluges straks efter fremstilling.
English: • if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents).
Danish: • hvis du lægger mærke til ændringer i adfærd eller humør (neuropsykiatriske hændelser), især hos børn og unge.
English: • if the influenza symptoms get worse or the fever continues Tell your doctor as soon as possible.
Danish: • hvis influenzasymptomerne forværres eller feberen fortsætter så kontakt lægen så hurtigt som muligt
English: Always use 55 ml of water, whatever the dose you need.
Danish: Du skal altid bruge 55 ml vand, uanset hvilken dosis du skal bruge.
English: Always shake well before use.
Danish: Ryst altid grundigt inden anvendelse.
English: Foetal exposure in the rats and rabbits was approximately 15 to 20 % of that of the mother.
Danish: Føtal eksponering hos rotter og kaniner var ca. 15 til 20 % af eksponeringen hos moderen.
English: The oral suspension can be used by people who find it hard to take capsules.
Danish: Den orale suspension kan anvendes af mennesker, som har svært ved at sluge kapsler.
English: The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations.
Danish: Anvendelsen af antivirale lægemidler til behandling og forebyggelse af influenza skal besluttes på grundlag af officielle rekommendationer.
English: • if your immune system is not working
Danish: • hvis dit immunforsvar ikke virker
English: These reactions were seen at doses of 657 mg/kg and higher.
Danish: Disse virkninger forekom ved doser på 657 mg/kg og højere.
English: Stop at the mark that shows the dose you need.
Danish: Stop ved det mærke, som angiver den dosis, du skal bruge.
English: The pharmacy preparation should be preferred to home preparation.
Danish: Apoteksfremstilling bør foretrækkes frem for fremstilling hjemme.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl er nået (lægemiddelovervågning eller risikominimering).
English: Step 3: Choose the correct amount for your child's weight
Danish: Trin 3: Vælg den korrekte mængde ud fra barnets vægt
English: The undissolved powder is just inactive ingredients.
Danish: Det uopløste pulver er blot inaktive indholdsstoffer.
English: Triplex blister pack (PVC/PE/PVDC, sealed with aluminium foil).
Danish: Triplex blisterpakke (PVC/PE/PVDC, forseglet med aluminiumfolie).
English: • Prepare the oral dispenser
Danish: • Klargør den orale dispenser
English: Then turn the whole unit upside down (bottle and dispenser together).
Danish: Vend bunden i vejret på det hele (flaske og dispenser sammen).
English: This pharmacy preparation is the preferred option.
Danish: En apoteksfremstillet suspension er det foretrukne valg.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Tamiflu in one or more subsets of the paediatric population in influenza.
Danish: Det Europæiske Lægemiddelagentur (EMA) har dispenseret fra kravet om fremlæggelse af resultaterne fra studier med Tamiflu i en eller flere undergrupper af den pædiatriske population ved influenza.
English: The powder is a granulate or clumped granulate with a white to light yellow colour.
Danish: Pulveret er et granulat eller klumpet granulat med en hvid til lysegul farve.
English: The protection against influenza lasts only as long as Tamiflu is administered.
Danish: Beskyttelsen imod influenza varer kun så længe, som der gives Tamiflu.
English: Infant (<1 year) * Full genotyping was not performed in all studies.
Danish: Spædbørn (< 1 år) * Fuld genotypetestning blev ikke udført i alle forsøg.
English: • Close the bottle again
Danish: • Luk flasken igen
English: You only need to do this once, at the beginning of your course.
Danish: Du behøver kun at gøre dette én gang, når du påbegynder behandlingen.
English: There are two stages to taking Tamiflu oral suspension.
Danish: Der er to trin ved indtagning af Tamiflu oral suspension.