FrancophonIA/ELRC3.0 huggingface dataset:
English: A fall in the UPDRS score indicates an improvement in symptoms, while a rise indicates a worsening of symptoms.
Danish: Et fald i UPDRS-scoren betyder en forbedring af symptomerne, mens en stigning betyder en forværring.
English: Neurotransmitters are chemicals that nerve cells use to communicate with neighbouring cells.
Danish: Neurotransmittere er kemiske stoffer, som nervecellerne anvender til deres indbyrdes kommunikation.
English: For more information about treatment with Azilect, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Azilect, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The most common side effect with Azilect (seen in more than 1 patient in 10) is headache.
Danish: Den hyppigste bivirkning ved Azilect (som optræder hos flere end 1 ud af 10 patienter) er hovedpine.
English: Azilect must not be used in patients who have severe problems with their liver.
Danish: Azilect bør ikke anvendes hos patienter med svær leversygdom.
English: The other two studies involved a total of 1,159 patients with later stage disease, where Azilect was added to the patients' existing treatment including levodopa.
Danish: De to andre undersøgelser omfattede i alt 1 159 patienter med sygdommen i senere stadium, hvor Azilect blev givet som tillægsbehandling til den eksisterende behandling, herunder levodopa.
English: The main measure of effectiveness was the change in symptoms over 26 weeks, as assessed on a standard scale (Unified Parkinson's Disease Rating Scale, UPDRS).
Danish: Det primære effektmål var ændringen i symptomerne over 26 uger vurderet på en standardskala (UPDRS, Unified Parkinson's Disease Rating Scale).
English: The CHMP decided that Azilect's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Azilect opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Azilect.
English: It was compared with placebo or entacapone (another medicine for Parkinson's disease).
Danish: Det blev sammenlignet med placebo eller entacapon (et andet lægemiddel, der anvendes ved Parkinsons sygdom).
English: Azilect can be used either alone, or as an add-on to levodopa (another medicine used in Parkinson's disease) in patients who are having ‘fluctuations' towards the end of the period between levodopa doses.
Danish: Azilect kan anvendes enten alene eller som en tillægsbehandling til levodopa (et andet lægemiddel, der anvendes ved Parkinsons sygdom) hos patienter, der har "fluktuationer" mod slutningen af perioden mellem levodopa-doserne.
English: What is the risk associated with Azilect?
Danish: Hvilken risiko er der forbundet med Azilect?
English: The active substance in Azilect, rasagiline, is a ‘monoamine oxidase-B inhibitor'.
Danish: Det aktive stof i Azilect, rasagilin, er en "monoaminoxidase-B-hæmmer".
English: In the study where Azilect was used alone, patients taking 1 mg of the medicine once a day had an average fall in UPDRS score of 0.13 points over the 26-week study from a starting value of 24.69.
Danish: I den undersøgelse, hvor Azilect anvendtes alene, gav 1 mg én gang dagligt i løbet af undersøgelsens 26 ugers varighed et gennemsnitligt fald i UPDRS-scoren på 0,13 points fra startværdien på 24,69.
English: The main measure of effectiveness was the time spent in the ‘off' state during the day, as recorded in patients' diaries.
Danish: Det primære effektmål var den tid, patienterne var i "off-tilstand" i løbet af dagen, således som registreret i patientdagbøgerne.
English: There should be at least 14 days between stopping treatment with Azilect and starting treatment with another monoamine oxidase inhibitor or with pethidine.
Danish: Efter ophør af behandlingen med Azilect skal der gå mindst 14 dage før påbegyndelse af behandling med en anden monoaminoxidasehæmmer eller petidin.
English: It must also not be used with pethidine (a painkiller).
Danish: Det må heller ikke anvendes sammen med petidin (et smertestillende middel).
English: For the full list of all side effects reported with Azilect, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Azilect fremgår af indlægssedlen.
English: In the first study, two different doses of Azilect taken alone were compared with placebo (a dummy treatment) in 404 patients with early-stage disease.
Danish: I den første undersøgelse blev virkningerne af to forskellige doser af Azilect anvendt alene sammenlignet med virkningerne af placebo (en virkningsløs behandling) hos 404 patienter med sygdommen i et tidligt stadium.
English: In both studies, patients adding Azilect spent an average of around one hour less in the ‘off' state than those adding placebo.
Danish: I begge undersøgelser tilbragte de patienter, der fik Azilect som tillægsbehandling, ca. en time mindre i "off-tilstand" end dem, der fik placebo.
English: By increasing levels of dopamine in the parts of the brain that control movement and co-ordination, Azilect improves the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Danish: Ved at øge dopaminindholdet i de dele af hjernen, der styrer bevægelser og ko-ordinering, bedrer Azilect symptomerne på Parkinsons sygdom såsom stivhed og langsomme bevægelser.
English: This was compared with a rise of 4.07 points in the patients taking placebo from a starting value of 24.54.
Danish: Til sammenligning fik patienterne på placebo en stigning på 4,07 points fra en startværdi på 24,54.
English: Why has Azilect been approved?
Danish: Hvorfor blev Azilect godkendt?
English: A similar decrease in time spent in the ‘off' state was seen in patients taking entacapone.
Danish: En tilsvarende mindskelse af tiden i "off-tilstand" sås hos de patienter, der fik entacapon.
English: Fluctuations are linked to a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and immobile.
Danish: Fluktuationer er forbundet med den aftagende virkning af levodopa, der for patienten medfører pludselige skift mellem "on-perioder", hvor patienten kan bevæge sig, og "offperioder", hvor patienten er immobil.
English: What is Azilect?
Danish: Hvad er Azilect?
English: Azilect must not be used with other monoamine oxidase inhibitors including medicines and herbal preparations obtained without prescription such as St John's wort.
Danish: Azilect må ikke anvendes sammen med andre monoaminoxidasehæmmere, herunder ikkereceptpligtige lægemidler og drogetilberedninger såsom perikum.
English: When used as an add-on to levodopa, 1 mg Azilect reduced the time in the ‘off' state more than placebo did.
Danish: Som tillægsbehandling til levodopa var 1 mg Azilect bedre end placebo til at forkorte tiden i "offtilstand”.
English: How has Azilect been studied?
Danish: Hvordan blev Azilect undersøgt?
English: What benefit has Azilect shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Azilect?
English: What is Azilect used for?
Danish: Hvad anvendes Azilect til?
English: How is Azilect used?
Danish: Hvordan anvendes Azilect?
English: How does Azilect work?
Danish: Hvordan virker Azilect?
English: VeraSeal received a marketing authorisation valid throughout the EU on 10 November 2017.
Danish: VeraSeal fik en markedsføringstilladelse med gyldighed i hele EU den 10. november 2017.
English: Other information about VeraSeal
Danish: Andre oplysninger om VeraSeal
English: Further information on VeraSeal can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/veraseal
Danish: Yderligere information om VeraSeal findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/veraseal
English: As for all medicines, data on the use of VeraSeal are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af VeraSeal løbende overvåget.
English: The European Medicines Agency therefore decided that VeraSeal's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved VeraSeal opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What is VeraSeal and what is it used for?
Danish: Hvad er VeraSeal, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of VeraSeal?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af VeraSeal?
English: An overview of VeraSeal and why it is authorised in the EU
Danish: En oversigt over VeraSeal, og hvorfor det er godkendt i EU
English: Although patients could develop antibodies against the medicine, which might reduce its effectiveness, this has not been seen in the studies.
Danish: Selvom patienterne kan udvikle antistoffer mod lægemidlet og dermed nedsætte dets effektivitet, er dette ikke set i studierne.
English: VeraSeal is used when standard surgery techniques do not work well enough.
Danish: VeraSeal anvendes, når de gængse operationsteknikker ikke er tilstrækkelige.
English: Why is VeraSeal authorised in the EU?
Danish: Hvorfor er VeraSeal godkendt i EU?
English: Rarely, VeraSeal may cause an allergic reaction which can be severe especially when the medicine is used repeatedly.
Danish: VeraSeal kan i sjældne tilfælde forårsage en allergisk reaktion, som kan være alvorlig, navnlig ved gentagen anvendelse.
English: Side effects reported with VeraSeal are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved VeraSeal vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: The amount of VeraSeal to be used depends on a number of factors, including the type of surgery, the size of the wound and the number of applications.
Danish: Den mængde VeraSeal, der skal anvendes, afhænger af en række faktorer, herunder operationstype, sårstørrelse og antal påføringer.
English: It is available as two prefilled syringes in a syringe holder, one containing a solution of human fibrinogen (80 mg/ml), and the other containing a solution of human thrombin (500 international units/ml).
Danish: VeraSeal fås som to fyldte sprøjter i en sprøjteholder, hvor den ene indeholder en opløsning af humant fibrinogen (80 mg/ml), og den anden indeholder en opløsning af humant trombin (500 internationale enheder/ml).
English: VeraSeal (human fibrinogen / human thrombin) EMA/687019/2019
Danish: VeraSeal (humant fibrinogen/humant trombin) EMA/687019/2019
English: The active substances in VeraSeal, fibrinogen and thrombin, are substances present in human plasma (the liquid part of the blood), which are involved in the normal blood clotting process.
Danish: De aktive stoffer i VeraSeal, fibrinogen og trombin, er stoffer, der findes i humant plasma (blodvæske), og som indgår i den normale blodstørkningsproces.
English: The most common side effects with VeraSeal (which may affect up to 1 in 10 people) are nausea (feeling sick), pruritus (itchiness) and procedural pain (pain from the surgery).
Danish: De hyppigste bivirkninger ved VeraSeal (som kan forekomme hos op til 1 ud af 10 personer) er kvalme, kløe og indgrebsrelaterede smerter (smerter fra operationen).
English: As for all medicines obtained from blood, infections could be transmitted with the medicine; however, the medicine is manufactured using filtration and a process to inactivate viruses that minimise this risk.
Danish: Som ved alle lægemidler, der udvindes af blod, kan der ske overførsel af infektioner via VeraSeal, men det er fremstillet ved brug af filtrering og en proces til inaktivering af virusser, så risikoen er minimal.
English: VeraSeal (human fibrinogen / human thrombin)
Danish: VeraSeal (humant fibrinogen/humant trombin)
English: What are the risks associated with VeraSeal?
Danish: Hvilke risici er der forbundet med VeraSeal?
English: It contains the active substances human fibrinogen and human thrombin.
Danish: Det indeholder de aktive stoffer humant fibrinogen og humant trombin.
English: In rare cases, patients have developed antibodies to the proteins in VeraSeal, which could interfere with blood clotting.
Danish: I sjældne tilfælde har patienter udviklet antistoffer mod proteinerne i VeraSeal, hvilket kan påvirke blodets størkningsproces.
English: Three main studies in 614 patients found that VeraSeal is effective at stopping bleeding within 4 minutes of applying it during surgery.
Danish: Tre hovedstudier med deltagelse af 614 patienter har vist, at VeraSeal er effektivt til at standse blødning inden for 4 minutter efter påføring i forbindelse med kirurgi.
English: The observed side effects were as expected with major surgeries or the patient's condition.
Danish: De observerede bivirkninger var som forventet i betragtning af operationens omfang eller patientens tilstand.
English: Before use, the syringes are attached to a device supplied with the medicine that allows their contents to mix as they are dripped or sprayed on the wound.
Danish: Inden brug fastgøres sprøjterne til en medleveret anordning, der sørger for, at sprøjternes indhold blandes, mens det dryppes eller sprayes på såret.
English: VeraSeal has been shown to effectively stop bleeding during surgery, which can be expected to reduce blood loss, reduce time in the operating theatre and possibly shorten hospital stays.
Danish: Det er påvist, at VeraSeal er effektivt til at standse blødning i forbindelse med operative indgreb; VeraSeal forventes således at kunne reducere patientens blodtab, reducere tiden på operationsstuen og eventuelt afkorte hospitalsopholdet.
English: For the full list of all side effects and restrictions with VeraSeal, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved VeraSeal fremgår af indlægssedlen.
English: VeraSeal should only be used by an experienced surgeon who has been trained in its use.
Danish: VeraSeal må kun anvendes af en specialkirurg med erfaring i brug af vævsklæber.
English: When the two active substances are mixed, thrombin cuts fibrinogen up into fibrin.
Danish: Når de to aktive stoffer blandes, sørger trombinet for, at fibrinogenet spaltes til fibrin (trådstof).
English: VeraSeal must not be used intravascularly (inside blood vessels) or to treat heavy bleeding of the arteries.
Danish: VeraSeal må ikke anvendes intravaskulært (inde i blodkar) eller til behandling af kraftig pulsåreblødning.
English: How is VeraSeal used?
Danish: Hvordan anvendes VeraSeal?
English: What benefits of VeraSeal have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved VeraSeal?
English: The fibrin then aggregates (sticks together) and forms a fibrin clot that helps the wound to heal, preventing bleeding.
Danish: Fibrinet klæber derefter sammen til en fibrinklump, som medvirker til sårets heling ved at forhindre blødning.
English: VeraSeal is a sealant (glue) used to stop bleeding during surgery or to support stitches during surgery on blood vessels.
Danish: VeraSeal er en vævsklæber (en slags lim), der anvendes til standsning af blødning under operative indgreb eller til understøttelse af sting ved kirurgi i blodkar.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of VeraSeal 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 VeraSeal.
English: In a second study of organ surgery, VeraSeal was as effective as another product Surgicel: 93% of the patients had no bleeding 4 minutes after treatment with VeraSeal (103 out of 111), while 81% of the patients had no bleeding with Surgicel (91 out of 113).
Danish: I et andet studie i forbindelse med organkirurgi var VeraSeal lige så effektivt som et andet produkt, Surgicel: Hos 93 % af patienterne blev blødningen standset inden for 4 minutter efter påføring af VeraSeal (103 ud af 111), mens blødningen blev standset hos 81 % af patienterne ved anvendelse af Surgicel (91 ud af 113).
English: In one study of blood vessel surgery, VeraSeal worked better than manual compression, with 76% of patients having no bleeding 4 minutes after treatment with VeraSeal (83 out of 109), compared with 23% after manual compression (13 out of 57).
Danish: I et studie i forbindelse med blodkarkirurgi virkede VeraSeal bedre end manuel kompression, idet blødningen blev standset hos 76 % af patienterne inden for 4 minutter efter påføring af VeraSeal (83 ud af 109), sammenholdt med 23 % efter manuel kompression (13 ud af 57).
English: Finally, in a third study of soft tissue surgery, VeraSeal was as effective as Surgicel: 83% of the patients had no bleeding 4 minutes after treatment with VeraSeal (96 out of 116), compared with 78% of the patients after treatment with Surgicel (84 out of 108).
Danish: Endelig var VeraSeal lige så effektivt som Surgicel i et tredje studie i forbindelse med bløddelskirurgi: Hos 83 % af patienterne blev blødningen standset inden for 4 minutter efter påføring af VeraSeal (96 ud af 116), sammenholdt med 78 % af patienterne ved anvendelse af Surgicel (84 ud af 108).
English: How does VeraSeal work?
Danish: Hvordan virker VeraSeal?
English: Thromboembolic complications (blood clots) may occur if VeraSeal is accidentally injected into a blood vessel.
Danish: Hvis VeraSeal utilsigtet føres ind i et blodkar, kan det medføre tromboemboliske komplikationer (blodpropper).
English: It spreads rapidly around the world.
Danish: Den spreder sig hurtigt over hele verden.
English: Two doses are recommended for all children and adolescents.
Danish: To doser anbefales til alle børn og unge.
English: See section 5 for advice on storage and disposal.
Danish: Se punkt 5 for råd om opbevaring og bortskaffelse.
English: Other special populations:
Danish: Andre særlige populationer:
English: Date of first authorisation: 20 May 2016 Date of latest renewal: 4 April 2018
Danish: Dato for første markedsføringstilladelse: 20. maj 2016 Dato for seneste fornyelse: 4. april 2018
English: Small white particles may be present.
Danish: Den kan indeholde små hvide partikler.
English: This product contains a genetically modified organism (GMO).
Danish: Præparatet indeholder en genmodificeret organisme (GMO).
English: The safety and efficacy of the vaccine in this population has not been established.
Danish: Sikkerhed og effekt af vaccinen i denne population er ikke fastlagt.
English: Method of administration Immunisation must be carried out by nasal administration.
Danish: Immuniseringen skal ske via nasal administration.
English: At the time of approval of the next pandemic variation
Danish: På tidspunktet for godkendelse af en variation under den næste pandemi
English: Before use, the vaccine may be taken out of the refrigerator once for a maximum period of 12 hours at a temperature not above 25°C.
Danish: Før brug kan vaccinen tages ud af køleskabet én gang og opbevares i højst 12 timer ved en temperatur på ikke over 25 °C.
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a State laboratory or a laboratory designated for that purpose.
Danish: I henhold til artikel 114 i direktiv 2001/83/EC foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium udpeget hertil.
English: You do not need to actively inhale or sniff.
Danish: Du behøver ikke at inhalere aktivt eller snøfte.
English: Age range as described in the protocol for the study.
Danish: Aldersinterval som beskrevet i studieprotokollen.
English: If the vaccine has not been used after this 12-hour period, it should be discarded.
Danish: Hvis vaccinen ikke er anvendt efter disse 12 timer, skal den kasseres.
English: Four placebo-controlled studies included second season revaccination.
Danish: Fire placebokontrollerede studier omfattede revaccination i anden sæson.
English: Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades.
Danish: Pandemisk influenza er en type influenza, der forekommer i intervaller, der varierer fra under 10 år til mange årtier.
English: After declaration in the EU of a pandemic and after implementation of the pandemic vaccine
Danish: Efter erklæring af en pandemi i EU og efter implementering af pandemivaccinen
English: A/Vietnam/1203/2004 (H5N1) strain (A/Vietnam/1203/2004, MEDI 0141000136)
Danish: A/Vietnam/1203/2004 (H5N1)-stamme (A/Vietnam/1203/2004, MEDI 0141000136)
English: See Table 1 and 2 for a summary of efficacy results in the paediatric population.
Danish: Se tabel 1 og 2 for en sammenfatning af effektresultater i den pædiatriske population.
English: Children less than 12 months of age should not receive this vaccine because of the risk of side effects.
Danish: Børn under 12 måneder bør ikke få denne vaccine på grund af risiko for bivirkninger.
English: The signs of pandemic flu are similar to those of ordinary flu but may be more serious.
Danish: Tegnene på pandemisk influenza ligner symptomerne på almindelig influenza, men kan være alvorligere.
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Danish: Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14, stk. 7, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for de fastsatte tidsrammer gennemføre følgende foranstaltninger:
English: Adults aged 18 to 49 years
Danish: Voksne i alderen 18 til 49 år
English: • if you have been told by your doctor that you have a weakened immune system as a result of a disease, medicine, or other treatment.
Danish: • hvis lægen har fortalt dig, at du har et svækket immunsystem som resultat af en sygdom, et lægemiddel eller anden behandling.
English: The following information is intended for healthcare professionals only:
Danish: Nedenstående oplysninger er kun til læger og sundhedspersonale:
English: For nasal use only.
Danish: Kun til nasal brug.
English: • if you have a blood disorder or a cancer that affects the immune system.
Danish: • hvis du har en blodsygdom eller en type kræft, der påvirker immunsystemet.
English: • if you have severe asthma or are currently wheezing.
Danish: • hvis du har alvorlig astma eller i øjeblikket har hvæsende vejrtrækning.
English: Seroresponse rates were slightly higher among subjects who were seronegative at baseline.
Danish: Seroresponseraterne var lidt højere blandt forsøgspersoner, som var seronegative ved baseline.
English: Immune response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Danish: Immunreaktionen hos patienter med endogen eller iatrogen immunsuppression kan være utilstrækkelig.
English: H1N1 pandemic LAIV vaccine in children aged 2 to 17 years
Danish: H1N1-pandemisk LAIV-vaccine til børn i alderen 2 til 17 år
English: 56 Days after inactivated vaccine
Danish: 56 dage efter inaktiveret vaccine
English: • severe allergic reaction: signs of a severe allergic reaction may include shortness of breath and swelling of the face or tongue.
Danish: • alvorlig allergisk reaktion: tegn på en svær overfølsomhedsreaktion kan omfatte stakåndethed og hævelse af ansigt eller tunge.
English: Adults aged 22 to 54 years
Danish: Voksne i alderen 22 til 54 år
English: 1 dose (0.2 ml) contains:
Danish: 1 dosis (0,2 ml) indeholder:
English: - This vaccine has been prescribed for you or your child only.
Danish: - Lægen har ordineret denne vaccine personligt til dig eller dit barn.
English: The influenza strain used for the vaccine in an offically declared pandemic is recommended by the World Health Organisation.
Danish: Influenzastammen, der anvendes til vaccinen i en officielt erklæret pandemi, er anbefalet af Verdenssundhedsorganisationen (WHO).