FrancophonIA/ELRC3.0 huggingface dataset:
English: PritorPlus was more effective at reducing diastolic blood pressure than telmisartan taken alone and than placebo.
Danish: PritorPlus var mere effektivt end placebo og telmisartan alene til at reducere det diastoliske blodtryk.
English: What is PritorPlus?
Danish: Hvad er PritorPlus?
English: How has PritorPlus been studied?
Danish: Hvordan blev PritorPlus undersøgt?
English: What is PritorPlus used for?
Danish: Hvad anvendes PritorPlus til?
English: What benefit has PritorPlus shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved PritorPlus?
English: How is PritorPlus used?
Danish: Hvordan anvendes PritorPlus?
English: How does PritorPlus work?
Danish: Hvordan virker PritorPlus?
English: Treatment can be repeated every three months if necessary.
Danish: Behandlingen kan om nødvendigt gentages hver tredje måned.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Visudyne on 27 July 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Visudyne den 27. juli 2000.
English: If necessary, the other eye can be treated with the laser immediately afterwards.
Danish: Det andet øje kan om nødvendigt behandles med laser umiddelbart efter.
English: Although the first study in occult disease showed some effectiveness, this was not confirmed in the second study.
Danish: Selv om den første undersøgelse af okkult sygdom viste en vis effekt, blev dette ikke bekræftet i den anden undersøgelse.
English: This document is a summary of the European Public Assessment Report (EPAR) for Visudyne.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Visudyne.
English: A patient was classified as a responder if the number of letters that they could see increased, stayed the same, or fell by less than 15.
Danish: En patient blev klassificeret som responderende, hvis antallet af bogstaver, han/hun kunne se, steg, forblev uændret eller faldt til under 15.
English: Visudyne is used to treat adults with:
Danish: Visudyne anvendes til at behandle voksne med:
English: This was followed by a confirmatory study in a further 364 patients that was carried out at the request of the CHMP.
Danish: Herefter fulgte en bekræftende undersøgelse, der omfattede yderligere 364 patienter og blev gennemført på anmodning af CHMP.
English: Some of these patients went on to receive Visudyne for up to five years.
Danish: Nogle af disse patienter fortsatte med at få Visudyne i op til fem år.
English: This helps to close up the abnormal blood vessels that cause AMD.
Danish: Dette medvirker til at aflukke de abnorme blodkar, der er årsag til AMD.
English: Other information about Visudyne:
Danish: Andre oplysninger om Visudyne:
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 Visudyne.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for at udstede en markedsføringstilladelse og til sine anbefalinger om, hvordan Visudyne skal anvendes.
English: In all three studies, the main measure of effectiveness was the number of patients who had responded to treatment after a year, measured using a standard eye test chart.
Danish: I alle tre undersøgelser var det primære effektmål antallet af patienter, som havde responderet på behandlingen efter et år, målt ved hjælp af et standarddiagram for øjentest.
English: The CHMP decided that Visudyne's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Visudyne opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The benefit of Visudyne was maintained for up to five years for both diseases.
Danish: Virkningen af Visudyne holdt til i op til fem år for begge sygdomme.
English: The most common side effects with Visudyne (seen in between 1 and 10 patients in 100) are hypercholesteraemia (high blood cholesterol levels), hypersensitivity (allergic reactions), severely reduced visual acuity (very unclear vision), visual impairment (such as unclear vision, blurred fuzzy vision or flashes of light), defects in the visual field (such as small areas of reduced vision, grey or dark haloes, and black spots), dyspnoea (shortness of breath), nausea (feeling sick), photosensitivity reactions (sunburn-like reactions following exposure to light), reactions at the injection site (pain, swelling, inflammation and leakage of fluid from the veins), asthenia (weakness), infusion-related pain (mainly chest and back pain), syncope (fainting), headache and dizziness.
Danish: De hyppigste bivirkninger ved Visudyne (som optræder hos mellem 1 og 10 ud af 100 patienter) er forhøjede kolesterolmængder i blodet, svært nedsat synsskarphed, synsforstyrrelser (såsom uklart syn, sløret og uklart syn eller lysglimt), fejl i synsfeltet (såsom små områder med nedsat syn, grå eller mørke ringe og sorte pletter), kvalme, lysoverfølsomhedsreaktioner (reaktioner, der ligner solskoldethed, efter at have været udsat for lys), reaktioner på injektionsstedet (smerter, hævelse,
English: The dose depends on the body surface area (calculated using the patient's height and weight).
Danish: Hos yngre patienter afhænger dosen af kropsfladearealet (beregnet efter patientens højde og vægt).
English: Visudyne is a medicine that contains the active substance verteporfin.
Danish: Visudyne er et lægemiddel, der indeholder det aktive stof verteporfin.
English: Visudyne must not be used in patients with porphyria (an inability to break down chemicals called porphyrins) or in patients with severe liver disease.
Danish: Visudyne må ikke anvendes til patienter med porfyri (manglende evne til at nedbryde kemiske stoffer kaldet porfyriner) eller til patienter med svær leversygdom.
English: When the laser light is shone into the eye, verteporfin is activated and generates toxic oxygen molecules which block blood vessels, damage and even kill cells.
Danish: Når laserlyset sendes ind i øjet, aktiveres verteporfin og danner toksiske oxygenmolekyler, som blokerer, beskadiger og endda dræber celler.
English: The active substance in Visudyne, verteporfin, is a photosensitising agent (a substance that changes when exposed to light).
Danish: Det aktive stof i Visudyne, verteporfin, er et fotosensibiliserende middel (et stof, der ændrer sig, når det udsættes for lys).
English: What is the risk associated with Visudyne?
Danish: Hvilken risiko er der forbundet med Visudyne?
English: Visudyne is used when the neovascularisation is subfoveal
Danish: Visudyne anvendes, når neovaskulariseringen er subfoveal
English: Visudyne was more effective than placebo in the studies of AMD and pathologic myopia.
Danish: Visudyne var mere effektivt end placebo i undersøgelserne af AMD og patologisk nærsynethed.
English: In the two studies of wet AMD, 61% of the patients receiving Visudyne had responded to treatment after a year (246 out of 402), compared with 46% of those receiving placebo (96 out of 207).
Danish: I de to undersøgelser af den "våde" form for AMD havde 61 % af de patienter, der fik Visudyne, responderet på behandlingen efter et år (246 ud af 402) sammenlignet med 46 % af dem, der fik placebo (96 ud af 207).
English: In the study of pathologic myopia, 86% of the patients receiving Visudyne had responded after a year (70 out of 81), compared with 67% of those receiving placebo (26 out of 39).
Danish: I undersøgelsen af patologisk nærsynethed havde 86% af de patienter, der fik Visudyne, responderet efter et år (70 ud af 81) sammenlignet med 67% af dem, der fik placebo (26 ud af 39).
English: Why has Visudyne been approved?
Danish: Hvorfor blev Visudyne godkendt?
English: • choroidal neovascularisation caused by pathologic myopia (a severe type of short-sightedness where the eyeball continues to grow, becoming longer than it should be).
Danish: • koroidal neovaskularisering forårsaget af patologisk nærsynethed (en alvorlig form for nærsynethed, hvor øjeæblet bliver ved med at vokse og bliver længere, end det skal).
English: The wet form of AMD is caused by choroidal neovascularisation (abnormal growth of blood vessels under the macula), which may leak fluid and blood and cause swelling.
Danish: Den våde form for AMD skyldes koroidal neovaskularisering (abnorm dannelse af blodkar under den gule plet), som kan afgive væske og blod og medføre hævelse.
English: Visudyne has been compared with placebo (a dummy treatment) in two studies involving a total of 609 AMD patients with classic subfoveal neovascularisation, and in one study involving 120 patients with neovascularisation caused by pathologic myopia.
Danish: Visudyne blev sammenlignet med placebo (en virkningsløs behandling) i to undersøgelser, som omfattede i alt 609 AMD-patienter med klassisk subfoveal koroidal neovaskularisering, og i en undersøgelse, som omfattede 120 patienter med neovaskularisering forårsaget af patologisk nærsynethed.
English: Visudyne is used when the neovascularisation is ‘predominantly classic' (when the blood vessels affected are well defined on an eye scan) and subfoveal (occurs in the area under the fovea - the central area of the macula);
Danish: Visudyne anvendes, når neovaskulariseringen er "overvejende klassisk" (når de berørte blodkar er lette at skille ud på en øjenscanning) og subfoveal (optræder i området under fovea - den centrale del af makula);
English: Visudyne should only be given by ophthalmologists (eye specialists) who have experience in the management of patients with AMD or pathological myopia.
Danish: Visudyne bør kun gives af øjenlæger (specialister) med erfaring i behandling af patienter med AMD eller patologisk nærsynethed.
English: For the full list of restrictions and side effects reported with Visudyne, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Visudyne fremgår af indlægssedlen.
English: • the ‘wet' form of age-related macular degeneration (AMD), a disease which affects the central part of the retina (called the macula) at the back of the eye.
Danish: • Den "våde" form for aldersbetinget makulær degeneration (AMD), der er en sygdom, som angriber den gule plet (nethindens centrale del, der også kaldes makula) i den bageste del af øjet.
English: What is Visudyne?
Danish: Hvad er Visudyne?
English: When Visudyne is injected into a patient, verteporfin is distributed within the body through the blood vessels, including the blood vessels at the back of the eye.
Danish: Efter infusion af Visudyne fordeler verteporfin sig i kroppen gennem blodkarrene, herunder karrene i øjets bagvæg.
English: It is used in ‘photodynamic therapy', a method of treatment that uses light (generally from a laser) to activate a photosensitising agent.
Danish: Det anvendes ved ‘fotodynamisk behandling', hvor et fotosensibiliserende middel aktiveres med lys (sædvanligvis laserlys).
English: Visudyne has also been compared with placebo in ‘occult' subfoveal choroidal neovascularisation (when the blood vessels affected are not well defined on the scan), in a two-year study involving 339 patients.
Danish: Visudyne blev desuden sammenlignet med placebo ved ‘okkult' subfoveal koroidal neovaskularisering (dvs. de abnorme blodkar trådte ikke tydeligt frem ved scanningen) i en undersøgelse, der varede to år og omfattede 339 patienter.
English: The benefit of Visudyne in occult subfoveal choroidal neovascularisation has not been established.
Danish: Der er ikke påvist effekt af Visudyne til behandling af subfoveal koroidal neovaskularisering.
English: The full EPAR for Visudyne can be found can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Visudyne findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Hvis du ønsker yderligere oplysninger om behandling med Visudyne, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is available as a powder that is made up into a solution for infusion (drip) into a vein.
Danish: Det leveres som et pulver, der efter opløsning indgives ved infusion (med drop i en vene).
English: First, the patient receives Visudyne as an infusion into a vein lasting 10 minutes.
Danish: Behandlingen med Visudyne finder sted i to trin: Først får patienten Visudyne som en infusion i en vene, der varer i 10 minutter.
English: What is Visudyne used for?
Danish: Hvad anvendes Visudyne til?
English: How has Visudyne been studied?
Danish: Hvordan blev Visudyne undersøgt?
English: What benefit has Visudyne shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Visudyne?
English: How is Visudyne used?
Danish: Hvordan anvendes Visudyne?
English: How does Visudyne work?
Danish: Hvordan virker Visudyne?
English: The second step, 15 minutes after the start of the infusion, is the activation of Visudyne in the eye using light generated by a laser beam.
Danish: Her bliver Visudyne aktiveret ved belysning af øjet med laserlys.
English: Administration should be performed as follows:
Danish: Administrationen skal foretages som følger:
English: FREQUENCY NOT KNOWN (CANNOT BE ESTIMATED FROM AVAILABLE DATA)
Danish: IKKE KENDT (kan ikke estimeres ud fra forhåndenværende data)
English: Fe or
Danish: Fe eller
English: A risk to breastfeeding newborns/infants cannot be excluded.
Danish: En risiko for nyfødte/spædbørn kan ikke udelukkes.
English: Summary of Efficacy Endpoints at Day 35 (Intent to Treat Population)
Danish: Resumé af effektendepunkter på dag 35 (Intention to Treat Population)
English: Pharmacotherapeutic group: Not yet assigned, ATC code: Not yet assigned
Danish: Farmakoterapeutisk klassifikation: Endnu ikke tildelt, ATC-kode: Endnu ikke tildelt
English: It is not known whether the active substance in this medicine can pass into breast milk.
Danish: Det vides ikke, om det aktive stof i denne medicin kan gå over i modermælk.
English: 29 of them were associated with hypersensitivity reactions.
Danish: 29 af disse var forbundet med overfølsomhedsreaktioner.
English: The principal efficacy results at Day 35 from the controlled phase of each study are shown in Table 3.
Danish: De vigtigste virkningsresultater på dag 35 fra den kontrollerede fase af hvert enkelt studie er vist i Tabel 3.
English: It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
Danish: Det er vigtigt at fortælle lægen, hvis du er gravid, tror du kan være gravid eller planlægger at blive gravid.
English: For all patients:
Danish: Alle patienter:
English: If this happens to you, do not drive or use any tools or machinery.
Danish: Hvis dette sker for dig, bør du ikke køre bil eller bruge værktøjer eller maskiner.
English: No change in dosage is recommended from Table 1.
Danish: Der anbefales ingen doseringsændring i forhold til Tabel 1.
English: All patients were receiving ESAs at Baseline.
Danish: Alle patienter fik ESAs ved baseline.
English: They may decide to stop the infusion.
Danish: I så tilfælde vil de eventuelt beslutte at stoppe infusionen.
English: In total 42 fatal cases have been reported cumulatively.
Danish: I alt er der indberettet 42 dødelige tilfælde kumulativt.
English: For maintenance therapy and patient monitoring, the recommendations of current guidelines (e.g. Revised European Best Practice Guidelines) should be followed.
Danish: For vedligeholdelsesbehandling og monitorerering af patienter bør anbefalingerne i gældende guidelines følges (f.eks. reviderede European Best Practice Guidelines).
English: There is no evidence that the risk of hypersensitivity reactions as such is increased in elderly patients however these patients have an increased risk of complications.
Danish: Der er intet tegn på, at risikoen for overfølsomhedsreaktioner som sådan er øget hos ældre patienter, men disse patienter har en øget risiko for komplikationer.
English: Your doctor will decide if additional doses of Rienso are needed and for how long.
Danish: Din læge vil beslutte, om der er behov for yderligere doser Rienso og i hvor lang tid.
English: The additional four cases were reported after this PSUR was submitted for assessment.
Danish: De andre fire tilfælde blev indberettet efter, at denne PSUR blev indsendt til vurdering.
English: Immunologic Disease or Infection
Danish: Immunologisk sygdom eller infektion
English: - if you have systemic lupus erythematosus.
Danish: - hvis du har systemisk lupus erythematosus.
English: Post-Marketing Data from Dialysis Clinics in the United States
Danish: Data efter markedsføring fra dialyseklinikker i USA
English: • Shelf-Life - 48 months
Danish: • Opbevaringstid - 48 måneder
English: Stability and Storage
Danish: Stabilitet og opbevaring
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Danish: CHMP er enig i de videnskabelige konklusioner, som PRAC har fremsat.
English: - if you have problems with your immune system.
Danish: - hvis du har problemer med immunsystemet.
English: - if you have any infections, including infections which have spread to your blood stream.
Danish: - hvis du har en infektion, det gælder også infektioner, der har bredt sig til blodbanen.
English: 31 July 2016
Danish: 31. juli 2016
English: Only one case of minor rash was observed.
Danish: Der blev kun observeret et enkelt tilfælde af mindre udslæt.
English: 31 October 2016
Danish: 31. oktober 2016
English: One of these three cases was also characterized as an anaphylactoid reaction.
Danish: Et af disse tre tilfælde blev også karakteriseret som en anafylaktoid reaktion.
English: Some people may feel dizzy, confused or lightheaded after receiving treatment.
Danish: Nogle mennesker kan føle sig svimle, konfuse eller øre efter at have fået behandlingen.
English: The MAH is of the opinion that the current EU SmPC accurately reflects the current literature and provides appropriate guidance to EU practitioners.
Danish: MAH er af den opfattelse, at det nuværende produktresumé i EU nøjagtigt afspejler den aktuelle litteratur og leverer passende vejledning for praktiserende læger i EU.
English: - if you have rheumatoid arthritis.
Danish: - hvis du har reumatoid artritis.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 June 2012
Danish: Dato for første markedsføringstilladelse: 15. juni 2012
English: The following information is intended for healthcare professionals only (see Section 3):
Danish: Følgende oplysninger er tiltænkt læger og sundhedspersonale (se punkt 3):
English: These reactions can be associated with heart and circulation complications, loss of consciousness and may result in death.
Danish: Disses reaktioner kan være forbundet med hjerte og kredsløbsproblemer og tab af bevidsthed og kan resultere i dødsfald.
English: Please immediately tell the doctor or nurse if you start to feel unwell.
Danish: Fortæl det straks til lægen eller sygeplejersken, hvis du begynder at føle dig utilpas.
English: The educational programme is aimed at highlighting the risks and warnings on hypersensitivity reactions and the monitoring of patients during and after administration.
Danish: Uddannelsesprogrammet har til formål at fremhæve risici og advarsler vedrørende overfølsomhedsreaktioner og monitorering af patienter under og efter administration.
English: The major study outcomes assessed the change in haemoglobin from Baseline to Day 35.
Danish: De vigtigste studieresultater vurderede ændringerne i hæmoglobin fra baseline til dag 35.
English: In 5 out of these 6 cases, ferumoxytol was administered via IV injection (either quick or slow IV push), for the remaining case the method of administration is unknown.
Danish: I 5 ud af disse 6 tilfælde blev ferumoxytol administreret som IV-injektion (enten hurtig eller langsom IV indgift), for det øvrige tilfælde er administrationsmetoden ukendt.
English: If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately.
Danish: Hvis der opstår overfølsomhedsreaktioner eller tegn på intolerans under indgivelse, skal behandlingen stoppes øjeblikkeligt.
English: Chemical and physical in-use stability has been demonstrated for 96 hours at 25 °C.
Danish: Kemisk og fysisk in use stabilitet er dokumenteret for 96 timer ved 25 °C.
English: You will be lying down and your blood pressure and pulse will be monitored.
Danish: Du skal ligge ned, og dit blodtryk og din puls bliver overvåget imens.
English: Such effects were not seen in the male animals of that study or in the 13 weeks repeated dose toxicity study in rats (without recovery).
Danish: Sådanne effekter blev ikke set hos handyrene i dette studie eller i det 13-ugers gentaget dosis toksicitetsstudie i rotter (uden restitution).
English: Adverse reactions reported in these patients were similar in character and frequency to those observed in the other clinical trials.
Danish: De indberettede bivirkninger fra disse patienter svarede i karakter og frekvens til det, der observeredes i de øvrige kliniske forsøg.
English: Taking into account the PRAC Assessment Report on the PSUR for Rienso, the scientific conclusions of PRAC are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR for Rienso er PRAC nået frem til følgende videnskabelige konklusioner:
English: Adverse reactions observed during clinical studies and post-marketing
Danish: Bivirkninger observeret under kliniske studier og post-markedsføring
English: You can also report any side effects directly to the national reporting system via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: > 50 kg Body Weight
Danish: >50 kg kropsvægt
English: • From a microbiological point of view, the product should be used immediately after first opening or immediately after dilution.
Danish: • Ud fra et mikrobiologisk synspunkt bør produktet anvendes straks efter første anbrud eller umiddelbart efter fortynding.
English: The clearance (CL) was decreased with increased doses of Rienso.
Danish: Clearance (CL) var nedsat ved øgede doser af Rienso.
English: It should be noted that 28 out of the 35 fatal cases of hypersensitivity reactions occurred in elderly patients (> 65 years of age).
Danish: Det skal bemærkes, at 28 ud af de 35 dødelige tilfælde af overfølsomhedsreaktioner forekom hos ældre patienter (> 65 år).
English: In some patients these allergic reactions can become severe or life-threatening (known as anaphylactic reactions).
Danish: Hos nogle patienter kan disse allergiske reaktioner blive alvorlige eller livstruende (kendt som anafylaktiske reaktioner).
English: The effect on vascular MR imaging lasts approximately 1-2 days while tissue diagnostic imaging may be affected for up to 6 months.
Danish: Påvirkningen på vaskulære MR-scanninger varer cirka 1-2 dage, mens vævsdiagnostisk billeddannelse kan påvirkes i op til 6 måneder.
English: Treatment with Rienso should be confined to second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus.
Danish: Behandling med Rienso bør begrænses til andet og tredje trimester, hvis fordelen vurderes at veje tungere end den potentielle risiko for både mor og foster.
English: The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).
Danish: Diagnosen jernmangel skal være baseret på egnede laboratorietests (se pkt.
English: Unresponsiveness Loss of consciousness
Danish: Manglende reaktion Tab af bevidsthed