FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the risks associated with Aubagio?
Danish: Hvilke risici er der forbundet med Aubagio?
English: The pack will also include information on a registry the company will set up to collect data on babies born to women treated with Aubagio, as well as a patient reminder card with key safety information for patients.
Danish: Pakken skal indeholde oplysninger om et register, som virksomheden skal oprette med data om børn født af kvinder behandlet med Aubagio, og et patientoplysningskort med vigtige sikkerhedsoplysninger til patienterne.
English: For more information about treatment with Aubagio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Aubagio, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In studies, Aubagio was shown to reduce relapses and delay the progression of disability in patients with relapsingremitting MS.
Danish: I undersøgelserne blev Aubagio påvist at reducere antallet af tilbagefald og forsinke udviklingen af invaliditet hos patienter med recidiverende-remitterende multipel sklerose.
English: Although the effects were modest, they were considered to be significant and similar to other MS treatments, although there were no conclusive results available from a direct comparison with interferon beta-1a.
Danish: Virkningerne var beskedne, men blev anset for at være væsentlige og at svare til virkningerne af andre midler mod multipel sklerose, skønt der ikke kom klare resultater af en direkte sammenligning med interferon beta-1a.
English: The fourth study involving 324 patients compared the effects of Aubagio with interferon beta-1a (another treatment for MS) on the rate of treatment failure, by looking at the time until patients had their first relapse or permanently stopped their treatment.
Danish: Den fjerde undersøgelse omfattede 324 patienter og sammenlignede virkningen af Aubagio med interferon beta-1a (et andet middel mod multipel sklerose) på andelen af behandlingssvigt, idet det i undersøgelsen registreredes, hvor lang tid der gik, før patienterne fik deres første tilbagefald eller ophørte varigt med behandlingen.
English: Aubagio has been studied in four main studies involving over 2,700 adults with relapsing-remitting MS.
Danish: Aubagio blev undersøgt i fire hovedundersøgelser omfattende 2 700 voksne med recidiverenderemitterende multipel sklerose.
English: Overall, no conclusion could be reached from this study on any differences between Aubagio and interferon beta-1a for MS treatment.
Danish: Overordnet gjorde undersøgelsen det ikke muligt at konkludere noget om forskellene mellem Aubagio og interferon beta1a til behandling af multipel sklerose.
English: For the full list of all side effects reported with Aubagio, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Aubagio fremgår af indlægssedlen.
English: One study involving 179 patients compared the effects of Aubagio with placebo (a dummy treatment) on the number of active lesions (developing areas of damage) in the brain detected by a brain scan.
Danish: Én undersøgelse med 179 patienter sammenlignede virkningerne af Aubagio med placebo (en virkningsløs behandling) på antallet af aktive forandringer (områder med fremadskridende beskadigelse) i hjernen, bestemt ved scanning af hjernen.
English: The studies also looked at the effect of Aubagio on the changes in the patients' level of disability and showed that the risk of disability getting worse was reduced by 30% in comparison with placebo after around two and a half years (132 weeks) of treatment.
Danish: I undersøgelserne registreredes desuden, hvordan Aubagio virkede på ændringen i patientens invaliditetsgrad: Risikoen for forværring af invaliditeten var 30 % mindre med Aubagio end med placebo efter omkring 2 ½ års (132 ugers) behandling.
English: Aubagio was found to be more effective than placebo: after around 9 months (36 weeks), the number of active lesions was around 1 per scan in patients who were taking Aubagio compared with around 2.7 in patients taking placebo.
Danish: Aubagio blev fundet at være mere effektivt end placebo: Efter ca. 9 måneder (36 uger) var antallet af aktive forandringer omkring 1 pr. scanning hos patienter, der fik Aubagio, sammenholdt med omkring 2,7 hos dem, der fik placebo.
English: Aubagio must also not be used in pregnant women or during breast-feeding.
Danish: Aubagio må desuden ikke anvendes hos patienter, der er gravide eller ammer.
English: Aubagio was found to be more effective than placebo: in patients taking Aubagio, relapses were reduced by around 30% more than in patients taking placebo (the annualised relapse rate was 0.35 for Aubagio compared with 0.53 for placebo).
Danish: Aubagio blev fundet at være mere effektivt end placebo: Hos de patienter, der fik Aubagio, faldt antallet af tilbagefald ca. 30 % mere end hos dem, der fik placebo (den årlige tilbagefaldsrate var 0,35 for Aubagio, sammenholdt med 0,53 for placebo).
English: Two studies involving 2,257 patients compared the effects of Aubagio with placebo in reducing the number of relapses per patient per year (called the ‘annualised relapse rate').
Danish: To undersøgelser med tilsammen 2 257 patienter sammenlignede Aubagio og placebos evne til at mindske antallet af tilbagefald pr. patient pr. år (den årlige tilbagefaldsrate).
English: However, the rate of relapse was 23.4% with Aubagio compared with 15.4% with interferon beta-1a.
Danish: Der var imidlertid tilbagefald hos 23,4 % af dem, der fik Aubagio, sammenholdt med 15,4 % af dem, der fik interferon beta-1a.
English: Aubagio is used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Danish: Det anvendes ved den form af sygdommen, der kaldes recidiverenderemitterende multipel sklerose, hvor patienten gentagne gange har tilbagefald af symptomer (recidiv) efterfulgt af perioder uden symptomer (remission).
English: For practical information about using Aubagio, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Aubagio, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aubagio, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for Aubagio er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: A 13.5% rate of permanent discontinuation was seen in patients taking Aubagio, compared with 24% in patients taking interferon beta-1a.
Danish: Behandlingen blev varigt indstillet hos 13,5 % af de patienter, der fik Aubagio, sammenholdt med 24 % af dem, der fik interferon beta-1a.
English: How is Aubagio used?
Danish: Hvordan anvendes Aubagio?
English: What benefits of Aubagio have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Aubagio?
English: • severe liver disease;
Danish: • svær leversygdom,
English: • severe kidney disease that requires dialysis;
Danish: • svær, dialysekrævende nyresygdom,
English: How does Aubagio work?
Danish: Hvordan virker Aubagio?
English: You may watch television.
Danish: De må godt se fjernsyn.
English: Your doctor will also tell you what to do.
Danish: Deres læge vil også fortælle Dem, hvad De skal gøre.
English: You can then repeat the test.
Danish: De kan så gentage prøven.
English: Date of first authorisation: 24 October 2001 Date of latest renewal: 22 September 2011
Danish: Dato for første markedsføringstilladelse: 24. oktober 2001 Dato for seneste fornyelse: 22. september 2011
English: •At the request of the European Medicines Agency;
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur
English: You must follow these instructions carefully.
Danish: De skal følge disse instruktioner nøje.
English: Most people will be able to go back to their normal routine by Day 22.
Danish: De fleste mennesker vil kunne gå tilbage til deres normale rutine på dag 22.
English: Day 1 (0-24 hours)
Danish: Dag 1 (0-24 timer)
English: These effects may make it difficult to eat and drink.
Danish: Disse bivirkninger kan gøre det vanskeligt at spise og drikke.
English: After 2 to 4 days, the treated area will turn black.
Danish: Efter 2 til 4 dage vil det behandlede område blive sort.
English: Start on Day 8 with 10-15 minutes outdoors.
Danish: Begynd dag 8 med 10-15 minutter udendørs.
English: Of these, 6 had a complete local response according to WHO criteria.
Danish: Af disse opnåede 6 en komplet lokal respons ifølge WHO kriterierne.
English: • Sunscreen creams will not prevent this sensitivity.
Danish: • Solbeskyttelsescreme vil ikke forhindre denne følsomhed.
English: Strict observance of the reduced light regime is required.
Danish: Der kræves nøje overholdelse af det reducerede lysregimen.
English: Events occurring at a frequency not known (frequency cannot be estimated from the available data):
Danish: Hændelser, der forekommer med en ikke kendt hyppighed (hyppigheden kan ikke vurderes ud fra tilgængelige data):
English: • Do not wear very thin clothing because it will not protect you from strong light.
Danish: • Brug ikke meget tyndt tøj, da det ikke vil beskytte Dem mod stærkt lys.
English: Do not use this medicine after the expiry date which is stated on the label and the carton.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og kartonen.
English: Each field is to be illuminated once only at each treatment.
Danish: Hvert felt må kun belyses én gang ved hver behandling.
English: You must get out of the light immediately.
Danish: De skal straks gå ud af lyset.
English: • These instructions are written in this leaflet.
Danish: • Disse instruktioner er skrevet i denne indlægsseddel.
English: Talk to your doctor for more information.
Danish: Kontakt lægen for flere oplysninger.
English: Furthermore you will probably notice swelling and reddening around the area that has been treated.
Danish: Desuden vil De sandsynligvis bemærke hævelse og rødme rundt om det behandlede område.
English: The laser light is not hot and will not burn.
Danish: Laserlyset er ikke varmt og vil ikke brænde Dem.
English: The type of clothes you must wear are:
Danish: De skal have følgende type tøj på:
English: Plasma protein binding is at 85-87 %.
Danish: Plasmaproteinbinding er 8587 %.
English: If you have this problem, wear dark glasses.
Danish: Hvis De har dette problem, skal De bruge mørke briller.
English: Appropriate precaution must be taken when handling this medicinal product.
Danish: Der skal træffes passende forholdsregler ved håndtering af dette lægemiddel.
English: Tel.: +49 3641 5195330 Fax: +49 3641 5195331
Danish: Tlf.: +49 3641 5195330 Fax: +49 3641 5195331
English: High rates of administration caused death in dogs and rabbits.
Danish: Høje indgivelseshastigheder forårsagede død hos hunde og kaniner.
English: Thirty-seven patients received at least 2 treatments with Foscan.
Danish: 37 patienter modtog mindst 2 behandlinger med Foscan.
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Frekvens er defineret som: meget almindelig (≥1/10), almindelig (≥1/100 til, <1/10), ikke almindelig (≥1/1.000 til, <1/100), sjælden (≥1/10.000 til, <1/1.000), meget sjælden (<1/10.000) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • Porphyria or other diseases exacerbated by light.
Danish: • Porfyri eller andre sygdomme, som forværres af lys
English: You can increase your exposure by another 15 minutes each day i.e. second day 30 minutes, third day 45 minutes, fourth day 60 minutes and so on.
Danish: De kan øge udsættelsen med endnu 15 minutter hver dag, dvs. den anden dag 30 minutter, den tredje dag 45 minutter, fjerde dag 60 minutter osv.
English: Such a reaction has been reported with topical 5-fluorouracil.
Danish: En sådan reaktion er blevet indberettet med topisk 5-fluorouracil.
English: Your eyes may be very sensitive to bright lights during this week.
Danish: Deres øjne kan være meget følsomme over for stærkt lys i denne uge.
English: This blackness is caused by dead cancer cells (necrosis).
Danish: Denne sorte farve skyldes døde kræftceller (nekrose).
English: • You will gradually become less sensitive to light.
Danish: • De vil efterhånden blive mindre følsom over for lys.
English: The median observed duration of tumour response for all patients was 57 days for overall response and 84 days for complete response.
Danish: Den mediane observerede varighed af tumorrespons for samtlige patienter var 57 dage for respons generelt og 84 dage for komplet respons.
English: • A planned surgical procedure within the next 30 days.
Danish: • Planlagt kirurgisk indgreb inden for de næste 30 dage
English: Stay in shaded areas or go out when it is cloudy.
Danish: Ophold Dem i skyggen eller gå ud, når det er overskyet.
English: Multiple non-overlapping fields may be illuminated.
Danish: Flere ikke-overlappende felter kan belyses.
English: What should I do to prevent burns?
Danish: Hvad bør jeg gøre for at forebygge forbrændinger?
English: It is important that patients are re-introduced to normal light gradually (see the light protection guidelines for patients at the end of this section).
Danish: Det er vigtigt, at patienter reintroduceres til normalt lys gradvist (se retningslinjerne for lysbeskyttelse i slutningen af dette punkt).
English: Single dose.
Danish: Enkeltdosis.
English: Days 8-14
Danish: Dag 8-14
English: • Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant.
Danish: • Spørg Deres læge eller apotekspersonale til råds, før De tager nogen form for medicin, hvis De er gravid.
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 (lægemiddelovervågning eller risikominimering) er nået.
English: Prophylactic treatment with corticosteroids should be considered.
Danish: Profylakse med kortikosteroider bør overvejes.
English: This pain will be controlled with painkillers.
Danish: Disse smerter vil blive kontrolleret med smertestillende midler.
English: Oximeters must be repositioned at least every 10-15 minutes to avoid the risk of local skin burns.
Danish: Oximetre skal omplaceres mindst hvert 10. - 15. minut for at undgå risikoen for lokale hudforbrændinger.
English: If it is absolutely necessary to go outdoors during the hours of daylight, you must be careful to cover up all your skin including your face and hands and wear dark glasses.
Danish: Hvis det er absolut nødvendigt at gå udendørs, når det er lyst, skal De være omhyggelig med at dække al huden til, også ansigtet og hænderne, og bruge mørke briller.
English: Foscan should not be used during pregnancy unless the clinical condition of the woman requires treatment with temoporfin.
Danish: Foscan bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver behandling med temoporfin.
English: • Four days after your injection, your doctor will treat your cancer with laser light.
Danish: • 4 dage efter indsprøjtningen vil Deres læge behandle Deres cancer med laserlys.
English: Wherever possible, the illuminated area must extend beyond the tumour margin by a distance of 0.5 cm.
Danish: Hvor det er muligt, skal det belyste område gå ud over tumormarginen i en afstand af 0,5 cm.
English: There is a risk of damage of the surrounding area following photoactivation.
Danish: Der er en risiko for beskadigelse af de omgivende områder efter fotoaktivering.
English: CALCULATION OF DOSE
Danish: BEREGNING AF DOSIS
English: If you do not follow these instructions, you may get severe sunburn that leads to permanent scarring.
Danish: Hvis De ikke følger disse instruktioner, kan De få alvorlig solskoldning, som medfører permanent ardannelse.
English: Although no other developmental effects were observed, the applied doses were not sufficiently in excess of the human therapeutic dose to provide an adequate margin of safety.
Danish: Selv om ingen andre udviklingseffekter blev observeret, var de anvendte doser ikke tilstrækkeligt højere end den humane terapeutiske dosis til at give en tilstrækkelig sikkerhedsmargin.
English: The following information is intended for medical or healthcare professionals only
Danish: Nedenstående oplysninger er til læger og sundhedspersonale:
English: There are no data from the use of temoporfin in pregnant women.
Danish: Der er ingen data fra anvendelse af temoprofin til gravide kvinder.
English: You may be given some medicine to reduce the swelling.
Danish: De kan få noget medicin til at reducere hævelsen.
English: The resulting complications (i.e. dyspnoea or even airway obstruction leading to, for instance, intubation or tracheotomy) should be anticipated.
Danish: De resulterende komplikationer (dvs. dyspnø eller endda luftvejsobstruktion, der f.eks. fører til intubering eller trakeotomi) bør forventes.
English: This means that normal daylight or bright indoor lighting could give you skin burns.
Danish: Det betyder, at normalt dagslys eller stærk indendørs belysning kan give Dem hudforbrændinger.
English: Do not stay in the sunlight for more than 15 minutes the first time.
Danish: Ophold Dem ikke længere end 15 minutter i solen første gang.
English: No other interactions have been observed.
Danish: Ingen interaktion er iagttaget.
English: On the first day after the skin test, you can stay in direct sunlight for 15 minutes.
Danish: På den første dag efter hudprøven kan De forblive i direkte sollys i 15 minutter.
English: Foscan contains ethanol (alcohol):
Danish: Foscan indeholder ethanol (alkohol):
English: No metabolites are seen in the systemic circulation.
Danish: Ingen metabolitter er set i den systemiske cirkulation.
English: A WHO local complete response was observed in 14 % of patients.
Danish: En lokal fuldstændig respons ifølge WHO kriterierne blev observeret hos 14 % af patienterne.
English: Common: Trismus Unknown: Fistula
Danish: Almindelig: Trismus Ikke kendt: Fistel
English: The genotoxicity of temoporfin has been investigated to a limited extent.
Danish: Genotoksiciteten af temoporfin er blevet undersøgt i et begrænset omfang.
English: Do NOT flush with aqueous solutions such as sodium chloride 9 mg/ml (0.9 %) solution for injection or water for injections.
Danish: Skyl IKKE med vandige opløsninger såsom 9 mg/ml (0,9 %) natriumkloridopløsning til injektion eller vand til injektion.
English: Foscan is non-irritant.
Danish: Foscan er ikke irriterende.
English: No specific systemic symptoms are known to be associated with overdose.
Danish: Det vides ikke, om der er specifikke systemiske symptomer forbundet med overdosering.
English: If extravasation occurs, protect the area from light for at least 3 months.
Danish: Hvis der opstår ekstravasation, skal området beskyttes mod lys i mindst 3 måneder.
English: Paediatric population There is no relevant use of Foscan in the paediatric population.
Danish: Pædiatrisk population Det er ikke relevant at anvende Foscan hos den pædiatriske population.
English: Stay in the shade.
Danish: Ophold Dem i skyggen.
English: Thus, an in-line filter must be used as a precautionary measure and is provided in the package.
Danish: Derfor skal der anvendes et in-line filter som en forebyggende foranstaltning, og dette leveres i pakken.
English: An extensive volume of distribution is observed that is intermediate between total and extracellular body water.
Danish: Der er iagttaget et omfattende fordelingsvolumen, som ligger mellem totalt og ekstracellulært legemsvand.
English: There is no enterohepatic recirculation of these metabolites.
Danish: Der er ingen enterohepatisk recirkulation af disse metabolitter.
English: Days 2-7
Danish: Dag 2-7
English: In the event of an overdose, laser treatment would result in deeper tumour necrosis than would be expected with the recommended dose.
Danish: I tilfælde af en overdosis ville laserbehandling medføre dybere tumornekrose, end man ville forvente med den anbefalede dosis.
English: Foscan will be stored at the hospital pharmacy.
Danish: Foscan vil blive opbevaret på hospitalsapoketet.
English: Stay indoors in a darkened room.
Danish: Ophold Dem indendørs i et mørklagt rum.
English: Published clinical research has shown that the duration and intensity of photosensitivity at the recommended dose of 0.15 mg/kg were reduced by one third relative to a dose of 0.3 mg/kg.
Danish: Publiceret klinisk forskning har vist, at varigheden og intensiteten af lysfølsomheden ved den anbefalede dosis på 0,15 mg/kg reduceres med en tredjedel i relation til en dosis på 0,3 mg/kg.
English: LASER ILLUMINATION OF TREATMENT SITE
Danish: LASERBELYSNING AF BEHANDLINGSSTEDET
English: • You may not be given the laser treatment.
Danish: • De må ikke få laserbehandling.
English: Common side effects (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 af 10 personer):
English: Do not use Foscan - if you are allergic to temoporfin or any of the other ingredients of this medicine (listed in section 6), - if you are hypersensitive (allergic) to porphyrins, - if you have porphyria, or any other disease that is made worse by light, - if the tumour being treated goes through a large blood vessel, - if you are going to have an operation in the next 30 days, - if you have an eye disease which needs examination with bright light in the next 30 days, - if you are already being treated with a photosensitising agent.
Danish: Brug ikke Foscan: - hvis De er allergisk over for temoporfin eller et af de øvrige indholdsstoffer i Foscan (angivet i punkt 6), - hvis De er overfølsom (allergisk) over for porfyriner, - hvis De har porfyri eller nogen anden sygdom, der forværres af lys, - hvis tumoren, som skal behandles, går igennem et stort blodkar, - hvis De skal opereres inden for de næste 30 dage, - hvis De har en øjensygdom, der skal undersøges med stærkt lys inden for de næste 30 dage, - hvis De allerede behandles med et lysfølsomhedsfremkaldende middel.
English: It is unknown whether temoporfin/metabolites are excreted in human milk.
Danish: Det er ukendt, om temoporfin/metabolitter udskilles i human mælk.
English: Injection site pain is transient and can be reduced by slowing the injection rate.
Danish: Smerte på injektionsstedet er forbigående og kan reduceres ved en langsommere injektionshastighed.
English: • You may feel some pain when Foscan is injected.
Danish: • De kan føle nogen smerte, når Foscan indsprøjtes.
English: Very common side effects (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (kan forekomme flere end 1 af 10 personer):
English: The low number of treated patients did not allow identification of adverse reactions, which may be categorised as uncommon and rare.
Danish: På grund af det lave antal behandlede patienter var det ikke muligt at identificere bivirkninger, der kan klassificeres som ikke almindelige eller sjældne.
English: The effects of Foscan on fertility in humans have not been studied.
Danish: Fertilitet Foscans virkning på menneskers fertilitet er ikke undersøgt.
English: ADMINISTRATION OF FOSCAN (96 hours prior to laser illumination of treatment site)
Danish: INDGIVELSE AF FOSCAN (96 timer før laserbelysning på behandlingsstedet)
English: Pain occurs the day after illumination and usually lasts 2 to 4 weeks.
Danish: Smerterne opstår dagen efter belysningen og varer normalt i 2 til 4 uger.