FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects and restrictions with Verkazia, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Verkazia fremgår af indlægssedlen.
English: Verkazia reduces damage to the cornea (layer in the front of the eye) in most patients with VKC as shown by improvements in ‘corneal fluorescence staining' (CFS) scores (a standard measure of corneal health).
Danish: Verkazia reducerer skaderne på hornhinden (den forreste glasklare del af øjeæblet) hos de fleste patienter med VKC i form af forbedrede scorer på den såkaldte "corneal fluorescence staining"-skala (CFS), der er et standardmål for hornhindens sundhed.
English: These symptoms usually occur when the drops are being put in the eyes and go away shortly after.
Danish: Disse symptomer ses typisk, når dråberne dryppes ind i øjnene, og fortager sig hurtigt bagefter.
English: Symptoms such as itching, fluid or mucous discharge and light sensitivity also improved in patients treated with Verkazia to a greater extent than with the dummy treatment.
Danish: Symptomer som kløe, øjenflåd/øjenslim og lysfølsomhed bedredes også i større omfang hos de patienter, der fik Verkazia, end hos dem, der fik placebo.
English: For practical information about using Verkazia, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Verkazia, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Some of the patients were treated for an additional 8 months; this extension study showed that the benefits of Verkazia were maintained with continued use for up to 12 months.
Danish: Denne forlængelsesundersøgelse viste, at fordelene ved Verkazia blev opretholdt ved fortsat brug i op til 12 måneder.
English: How is Verkazia used?
Danish: Hvordan anvendes Verkazia?
English: Side effects are mostly mild and disappear shortly after application of the medicine.
Danish: Bivirkningerne er oftest milde og fortager sig hurtigt efter drypning af øjnene.
English: What benefits of Verkazia have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Verkazia?
English: Verkazia can only be obtained with a prescription and treatment must be started by a healthcare professional qualified in ophthalmology (eye medicine).
Danish: Verkazia udleveres kun på recept, og behandlingen skal iværksættes af en erfaren øjenlæge.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Verkazia 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 Verkazia.
English: How does Verkazia work?
Danish: Hvordan virker Verkazia?
English: Verkazia is a medicine used to treat severe vernal keratoconjunctivitis (VKC), an allergic condition that affects the eye and mostly occurs seasonally, although in some patients symptoms can recur or persist all year round.
Danish: Tilstanden er typisk sæsonbetonet, men symptomerne kan hos nogle patienter opstå eller vedvare året rundt.
English: Starting doses are between 0.1 and 0.3 mg per kg bodyweight daily.
Danish: Begyndelsesdosen er 0,1-0,3 mg pr. kg legemsvægt pr. dag.
English: The full EPAR for Tacforius can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Tacforius findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Tacforius.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tacforius.
English: The prolonged-release capsules allow tacrolimus to be released slowly from the capsule over several hours so that it needs to be taken only once a day.
Danish: Depotkapslerne gør det muligt at frigive tacrolimus langsomt fra kapslen over flere timer, således at det kun skal tages én gang dagligt.
English: As for every medicine, the company provided studies on the quality of Tacforius.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Tacforius.
English: The Agency recommended that Tacforius be approved for use in the EU.
Danish: Agenturet anbefalede, at Tacforius godkendes til anvendelse i EU.
English: Tacforius should be taken once daily with water, on an empty stomach.
Danish: indtages én gang dagligt med et glas vand på tom mave.
English: What measures are being taken to ensure the safe and effective use of Tacforius?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tacforius?
English: The European Medicines Agency concluded that, in accordance with EU requirements, Tacforius has been shown to have comparable quality and to be bioequivalent to Advagraf.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Tacforius er af sammenlignelig kvalitet og er bioækvivalent med Advagraf.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Advagraf, and do not need to be repeated for Tacforius.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i de godkendte anvendelser for referencelægemidlet, Advagraf, og det er ikke nødvendigt at gentage disse for Tacforius.
English: Other information about Tacforius
Danish: Andre oplysninger om Tacforius
English: The doses are then adjusted according to the patient's response and the medicine's blood levels.
Danish: Doserne justeres derefter i henhold til patientens respons og koncentrationen af lægemidlet i blodet.
English: Doses of Tacforius are calculated on the basis of the patient's weight and the type of transplant the patient has had.
Danish: Doseringen af Tacforius beregnes på grundlag af patientens vægt og typen af transplantation, som vedkommende har gennemgået.
English: Only doctors experienced in immunosuppressive medicines and in the management of transplant patients should prescribe it and make changes to immunosuppressive treatment.
Danish: Kun læger, der har erfaring med immundæmpende lægemidler og håndtering af transplantationspatienter, bør ordinere dette lægemiddel og foretage ændringer af den immundæmpende behandling.
English: Because Tacforius is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Tacforius er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: What are the benefits and risks of Tacforius?
Danish: Hvilke fordele og risici er der forbundet med Tacforius?
English: What is Tacforius and what is it used for?
Danish: Hvad er Tacforius, og hvad anvendes det til?
English: Tacforius can only be obtained with a prescription.
Danish: Tacforius udleveres kun efter recept.
English: For more information about treatment with Tacforius, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Tacforius, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Tacrolimus, the active substance in Tacforius, is an immunosuppressive medicine.
Danish: Tacrolimus, det aktive stof i Tacforius, er et immundæmpende lægemiddel.
English: It is not intended to provide practical advice on how to use Tacforius.
Danish: Det er ikke en praktisk vejledning i, hvordan Tacforius bør anvendes.
English: Tacforius contains the active substance tacrolimus and is a ‘generic medicine'.
Danish: Tacforius indeholder det aktive stof tacrolimus og er et "generisk lægemiddel".
English: This means that Tacforius contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Advagraf.
Danish: Det betyder, at Tacforius er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Advagraf.
English: Tacrolimus reduces the activity of cells in the immune system, called T-cells, that are primarily involved in attacking the transplanted organ (organ rejection).
Danish: Tacrolimus reducerer aktiviteten af de såkaldte T-celler i immunsystemet, som er hovedansvarlige for, at det transplanterede organ angribes (afstødes).
English: Why is Tacforius approved?
Danish: Hvorfor blev Tacforius godkendt?
English: Therefore, the Agency's view was that, as for Advagraf, the benefit outweighs the identified risk.
Danish: Det var derfor agenturets opfattelse, at fordelene opvejer de identificerede risici som for Tacforius.
English: Tacforius is available as prolonged-release capsules containing tacrolimus.
Danish: Tacforius fås som depotkapsler, der indeholder tacrolimus.
English: For practical information about using Tacforius, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Tacforius, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Tacforius can also be used to treat organ rejection in adult patients when other immunosuppressive medicines (medicines that reduce the activity of the immune system) are not effective.
Danish: Tacforius kan desuden bruges til at behandle organafstødning hos voksne patienter, når andre immundæmpende lægemidler ikke virker.
English: Tacforius is used for the long-term treatment of adult patients who have had a kidney or liver transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Danish: Tacforius bruges som langtidsbehandling for at forebygge organafstødning hos voksne efter en nyreeller levertransplantation (ved afstødning angriber immunsystemet det transplanterede organ).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tacforius 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 Tacforius.
English: How has Tacforius been studied?
Danish: Hvordan er Tacforius blevet undersøgt?
English: How is Tacforius used?
Danish: Hvordan anvendes Tacforius?
English: How does Tacforius work?
Danish: Hvordan virker Tacforius?
English: Patients should take antibiotics for 2 weeks after they have been vaccinated.
Danish: Patienterne bør tage antibiotika i 2 uger, efter de er vaccineret.
English: Further information on Ultomiris can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ultomiris.
Danish: Yderligere information om Ultomiris findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Ultomiris.
English: The European Medicines Agency also noted that Ultomiris has a more convenient treatment schedule (with one infusion every 8 weeks instead of every 2 weeks).
Danish: Det Europæiske Lægemiddelagentur bemærkede også, at Ultomiris har en mere bekvem behandlingsplan (med én infusion hver 8. uge i stedet for hver 2. uge).
English: As for all medicines, data on the use of Ultomiris are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Ultomiris løbende overvåget.
English: It must also not be used in patients who have not been vaccinated against this infection unless they are taking antibiotics to reduce the risk of infection.
Danish: Det må heller ikke anvendes til patienter, der ikke er vaccineret mod denne infektion, medmindre de tager antibiotika for at mindske risikoen for infektion.
English: What measures are being taken to ensure the safe and effective use of Ultomiris?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ultomiris?
English: In addition, around half of the patients in both groups had achieved normal blood levels of the enzyme LDH.
Danish: Endvidere havde ca. halvdelen af patienterne i begge grupper opnået et normalt niveau af enzymet LDH i blodet.
English: Other information about Ultomiris
Danish: Andre oplysninger om Ultomiris
English: The Agency therefore decided that Ultomiris' benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Ultomiris opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The change in blood levels of LDH after 6 months of treatment was similar in the 2 groups.
Danish: Ændringen af LDH i blodet efter seks måneders behandling var ensartet i de to grupper.
English: For more information about using Ultomiris, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Ultomiris, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Patients receive an initial dose (called loading dose) and then a maintenance dose once every 8 weeks, starting 2 weeks after the loading dose.
Danish: Patienterne får en startdosis (også kaldet en støddosis) efterfulgt af en vedligeholdelsesdosis én gang hver 8. uge startende 2 uger efter indgivelse af støddosis.
English: Side effects reported with Ultomiris are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Ultomiris vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: It should be used after patients have been treated with eculizumab (another medicine for PNH) for at least the past 6 months.
Danish: Det bør anvendes, efter at patienterne er blevet behandlet med eculizumab (et andet PNH-lægemiddel) i mindst de seneste 6 måneder.
English: Ultomiris is given as an infusion (drip) into a vein and the recommended dose depends on the patient's bodyweight.
Danish: Ultomiris gives som en infusion (drop) i en vene, og den anbefalede dosis afhænger af patientens kropsvægt.
English: An overview of Ultomiris and why it is authorised in the EU
Danish: En oversigt over Ultomiris, og hvorfor det er godkendt i EU
English: Why is Ultomiris authorised in the EU?
Danish: Hvorfor blev Ultomiris godkendt i EU?
English: After 6 months of treatment, similar benefits were seen in both groups, with two-thirds or more of patients (74% given Ultomiris and 66% given eculizumab) not needing red blood cell transfusions.
Danish: Efter seks måneders behandling sås der ensartede fordele i begge grupper, hvor to tredjedele eller flere af patienterne (74 % ved Ultomiris og 66 % ved eculizumab) ikke havde brug for transfusion af røde blodlegemer.
English: In addition, none of the patients treated with Ultomiris had a flare-up of symptoms during this time, in comparison to 5 of those continuing with eculizumab.
Danish: Endvidere fik ingen af de patienter, der blev behandlet med Ultomiris, opblussede symptomer i denne periode sammenholdt med fem af dem, der fortsatte med eculizumab.
English: The most serious side effect is meningococcal infection, a bacterial infection caused by Neisseria meningitidis that can cause meningitis and blood poisoning.
Danish: Den alvorligste bivirkning er meningokokinfektion, som er en bakterieinfektion forårsaget af Neisseria meningitidis, der kan forårsage meningitis og blodforgiftning.
English: In PNH, proteins known as the 'complement system', which is part of the immune system, become overactive because of a genetic mutation and start to attack the patients' own red blood cells.
Danish: Ved PNH bliver en type proteiner kaldet "komplementsystemet", som er en del af immunsystemet, overaktive på grund af en genetisk mutation og begynder at angribe patientens egne røde blodlegemer.
English: What is Ultomiris and what is it used for?
Danish: Hvad er Ultomiris, og hvad anvendes det til?
English: The active substance contained in Ultomiris, ravulizumab, is a monoclonal antibody (a type of protein) designed to attach to the C5 protein, which is part of the complement system.
Danish: Det aktive stof i Ultomiris, ravulizumab, er et monoklonalt antistof (en type protein), som er beregnet til at binde sig til C5-proteinet, som er en del af komplementsystemet.
English: The most common side effects with Ultomiris (which may affect more than 1 in 10 people) are upper respiratory tract infection (nose and throat infection), nasopharyngitis (inflammation of the nose and throat) and headache.
Danish: De hyppigste bivirkninger ved Ultomiris (som optræder hos mere end 1 ud af 10 patienter) er infektion i de øvre luftveje (næse- og halsinfektion), nasofaryngitis (betændelse i næse og hals) og hovedpine.
English: Because patients treated with Ultomiris are more prone to infections, including severe meningococcal disease, Ultomiris must not be used in patients who have an ongoing meningococcal infection.
Danish: Idet patienter, der behandles med Ultomiris, er mere modtagelige for infektioner, herunder svær meningokoksygdom, må Ultomiris ikke anvendes til patienter med meningokokinfektion.
English: The company that markets Ultomiris will ensure that the medicine is only made available to patients when healthcare professionals have made a written declaration that they have been vaccinated or are receiving antibiotic treatment to prevent meningococcal disease.
Danish: Virksomheden, der markedsfører Ultomiris, sørger for, at lægemidlet kun gøres tilgængeligt for patienter, når en sundhedsperson har udstedt en skriftlig erklæring om, at de er vaccineret eller er i antibiotikabehandling for at forebygge meningokoksygdom.
English: Patients will also be given a special card that explains the symptoms of meningococcal infection, instructing patients to seek medical care immediately if they experience them.
Danish: Patienterne vil også få udleveret et særligt kort, der beskriver symptomerne ved meningokokinfektion og instruerer patienterne i straks at søge lægehjælp, hvis de oplever disse symptomer.
English: As for its safety, Ultomiris has similar side effects to eculizumab.
Danish: Med hensyn til sikkerheden svarer bivirkningerne ved Ultomiris til bivirkningerne ved eculizumab.
English: What are the risks associated with Ultomiris?
Danish: Hvilke risici er der forbundet med Ultomiris?
English: The medicine can only be obtained with a prescription and must be given under the supervision of a doctor who has experience in the management of patients with blood disorders.
Danish: Lægemidlet udleveres kun efter recept og skal indgives under opsyn af en læge med erfaring i behandling af patienter med blodsygdomme.
English: Ultomiris is used in patients who have symptoms of the disease as well as in patients who have stable blood levels of the enzyme lactate dehydrogenase (LDH), which gives an indication of how many red blood cells are being broken down.
Danish: Ultomiris anvendes hos patienter, der har symptomer på sygdommen, samt hos patienter med stabile niveauer af enzymet lactatdehydrogenase (LDH) i blodet, hvilket givet en indikation af, hvor mange røde blodlegemer der nedbrydes.
English: The company will also provide prescribers and patients with information on the safety of the medicine, and will send reminders to prescribers and pharmacists to check if re-vaccination is needed for patients taking Ultomiris.
Danish: Virksomheden vil også levere oplysninger til de ordinerende læger og patienterne om lægemidlets sikkerhed og sende påmindelser til de ordinerende læger og apotekerne om at kontrollere, om revaccination er nødvendig for patienter, der tager Ultomiris.
English: In the second study in 195 patients with PNH who did not have symptoms after at least 6 months of treatment with eculizumab, patients either continued treatment with eculizumab or switched to Ultomiris.
Danish: I det andet studie, der omfattede 195 patienter med PNH, som ikke havde symptomer efter mindst seks måneders behandling med eculizumab, fortsatte patienterne enten behandlingen med eculizumab eller skiftede til Ultomiris.
English: In the first study, 246 patients with PNH who previously had not been treated with a medicine blocking the complement system, such as eculizumab, received either Ultomiris or eculizumab.
Danish: I det første studie fik 246 patienter med PNH, som ikke tidligere var blevet behandlet med et lægemiddel, der blokerede komplementsystemet, såsom eculizumab, enten Ultomiris eller eculizumab.
English: Ultomiris is a medicine used to treat adults with paroxysmal nocturnal haemoglobinuria (PNH).
Danish: Ultomiris er et lægemiddel, som anvendes til behandling af voksne med paroksystisk nokturn hæmoglobinuri (PNH).
English: PNH is a potentially life-threatening disease in which there is excessive breakdown of red blood cells, leading to problems such as anaemia (low red blood cell counts), kidney problems and blood clots in the blood vessels.
Danish: PNH er en potentielt livstruende sygdom, hvor der sker en øget nedbrydning af de røde blodlegemer, hvilket medfører problemer såsom anæmi (lavt antal røde blodlegemer), nyreproblemer og blodpropper i blodkarrene.
English: For the full list of side effects and restrictions with Ultomiris, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Ultomiris fremgår af indlægssedlen.
English: Ultomiris contains the active substance ravulizumab.
Danish: Ultomiris indeholder det aktive stof ravulizumab.
English: Ultomiris is as effective as eculizumab in treating patients with PNH, reducing the breakdown of red blood cells and avoiding the need for transfusions.
Danish: Ultomiris er lige så effektivt som eculizumab til at behandle patienter med PNH, reducere nedbrydningen af røde blodlegemer og undgå nødvendigheden af transfusion.
English: This is a life-long treatment.
Danish: Behandlingen fortsætter i hele patientens liv.
English: Ultomiris was shown in 2 studies to be as effective as eculizumab in reducing the breakdown of red blood cells and avoiding the need for transfusions in patients with PNH.
Danish: Det blev i to studier påvist, at Ultomiris var lige så effektivt som eculizumab til at reducere nedbrydningen af røde blodlegemer og undgå, at der blev behov for transfusion hos patienter med PNH.
English: By attaching to the C5 protein, the medicine blocks its effect and thereby reduces the destruction of red blood cells.
Danish: proteinet, blokerer lægemidlet proteinets virkning og reducerer dermed nedbrydelsen af røde blodlegemer.
English: How is Ultomiris used?
Danish: Hvordan anvendes Ultomiris?
English: What benefits of Ultomiris have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Ultomiris?
English: How does Ultomiris work?
Danish: Hvordan virker Ultomiris?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ultomiris have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Ultomiris.
English: 2 years
Danish: 2 ár
English: Do not pass it on to others.
Danish: Ekki má gefa það öðrum.
English: Adults and elderly (> 65 years)
Danish: Fullorðnir og aldraðir (> 65 ára)
English: Please tell your doctor immediately:
Danish: Láttu lækninn vita tafarlaust:
English: You may need to read it again.
Danish: Nauðsynlegt getur verið að lesa hann síðar.
English: The risk of having seizures is higher if you have had them before;
Danish: Hættan á því að fá krampa er meiri ef þú hefur fengið þá áður;
English: Date of first authorisation: 19 November 2015
Danish: Dagsetning fyrstu útgáfu markaðsleyfis: 19. nóvember 2015
English: 117 Allee des Parcs 69 800 Saint Priest France
Danish: 117 Allee des Parcs 69 800 Saint Priest Frakkland