FrancophonIA/ELRC3.0 huggingface dataset:
English: Kiovig must not be used in people who are hypersensitive (allergic) to human normal immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of human immunoglobulin, especially where they have very low levels of immunoglobulin A (IgA) and they have antibodies against IgA.
Danish: Kiovig må ikke anvendes hos personer, der er overfølsomme (allergiske) over for normalt humant immunglobulin eller andre af indholdsstofferne, eller hos patienter, som er allergiske over for andre typer immunglobulin, navnlig hvis de har et meget lavt indhold af immunglobulin A (IgA) og danner antistoffer mod IgA.
English: In the first study, Kiovig was used to replace antibodies in 22 patients with PID who had very low or no levels of immunoglobulin.
Danish: I det første studie blev Kiovig brugt til at erstatte antistoffer hos 22 patienter med PID, som havde et meget lavt niveau af immunglobulin eller helt manglede dette.
English: These also include people who have developed a lack of antibodies after birth (secondary immunodeficiency syndrome, SID), who have low levels of certain antibodies (called IgG) and who suffer from infections that are severe, keep coming back, and are not cured by medicines used to treat infections;
Danish: Det kan også være personer, som har udviklet mangel på antistoffer efter fødslen (sekundært immundefektsyndrom (SID)), som har lave niveauer af visse antistoffer (kaldet IgG), og som lider af alvorlige infektioner, der er tilbagevendende og ikke kan helbredes ved hjælp af lægemidler til behandling af infektioner
English: Some side effects are more likely when using a high rate of infusion, in patients with low immunoglobulin levels, or in patients who have not received Kiovig before or for a long time.
Danish: Nogle bivirkninger er mere sandsynlige, hvis infusionshastigheden er høj, hvis patienten har et lavt indhold af immunglobulin, eller hvis patienten ikke har fået Kiovig før eller ikke har fået det i lang tid.
English: What benefits of Kiovig have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Kiovig?
English: Kiovig works by restoring abnormally low IgG levels to their normal range in the blood.
Danish: Kiovigs virkning består i, at det bringer et unormalt lavt IgGindhold i blodet tilbage til det normale.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kiovig 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 Kiovig.
English: Kiovig was shown to be effective in increasing the platelet count.
Danish: Kiovig øgede effektivt antallet af blodplader.
English: 3 x 28 film-coated tablets
Danish: 3 x 28 filmovertrukne tabletter
English: Pack size
Danish: Styrke
English: -- Each dose (2 ml) contains:
Danish: --1 Hver dosis (2 ml) indeholder:
English: Porcine Parvovirus strain 27a VP2 subunit antigen ≥ 1.0 RP* * Relative Potency (ELISA)
Danish: Porcint parvovirusstamme 27a VP2 subunit antigen ≥ 1.0 RP* *Relativ styrke (ELISA)
English: Immediate packaging
Danish: Indgivelsesvej Emballage Indhold Pakningsstørrelse
English: This summary was last updated in May 2014.
Danish: Dette sammendrag blev sidst ajourført i maj 2014.
English: The duration of protection was confirmed to be six months.
Danish: Beskyttelsen blev påvist at vare seks måneder.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Eryseng on 4 July 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Eryseng den 4. juli 2014.
English: The onset of immunity was shown to be three weeks.
Danish: Det tog tre uger at opnå immunitet.
English: In the control group more than 80% of pigs showed specific skin lesions.
Danish: I kontrolgruppen fik mere end 80 % af svinene specielle hudforandringer.
English: Other information about Eryseng:
Danish: Andre oplysninger om Eryseng:
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter lægemidlets indgivelse, før dyret kan slagtes, og kødet kan anvendes til konsum.
English: A single injection is given two to three weeks before each mating so approximately every six months.
Danish: Der gives en enkelt injektion 2-3 uger før hver bedækning, dvs. ca. hver sjette måned.
English: Swine erysipelas vaccine (inactivated)
Danish: Svineerysipelasvaccine (inaktiveret)
English: The withdrawal period for Eryseng is zero days.
Danish: Tilbageholdelsestiden for Eryseng er 0 døgn.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Eryseng exceed the risks for the approved indication and recommended that Eryseng be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Eryseng overstiger risiciene til den godkendte anvendelse, og anbefalede udstedelse af en markedsføringstilladelse for Eryseng.
English: The most common side effect (seen in more than 1 in 10 pigs) with Eryseng is mild to moderate inflammation at the injection site, which typically resolves within four days but in some cases may persist for up to 12 days post-vaccination.
Danish: Den hyppigste bivirkning (der ses hos mere end 1 ud af 10 svin) ved Eryseng er let til moderat inflammation på injektionsstedet, som typisk svinder i løbet af fire dage, men i visse tilfælde kan vare i op til 12 dage efter vaccinationen.
English: Eryseng is a bacterial vaccine.
Danish: Eryseng er en vaccine med bakterier.
English: In the future, if the animals are exposed to Erysipelothrix rhusiopathiae bacteria, the immune system will be able to respond more quickly.
Danish: Hvis dyret efterfølgende udsættes for disse Erysipelothrix rhusiopathiae-bakterier, vil immunsystemet reagere hurtigere.
English: The vaccine is given to pigs from six months of age as an injection into the neck muscles, repeated after three to four weeks.
Danish: Vaccinationen gives til svin fra 6-månedersalderen ved en indsprøjtning i nakkemuskulaturen og gentages efter 3-4 uger.
English: When Eryseng is given to pigs the animals' immune system recognises the bacteria as ‘foreign' and makes antibodies against them.
Danish: Når Eryseng gives til svin, registrerer dyrenes immunsystem bakterierne som “fremmede” og reagerer ved at danne antistoffer mod dem.
English: What is the risk associated with Eryseng?
Danish: Hvilken risiko er der forbundet med Eryseng?
English: In a laboratory study involving 40 pigs, 30 pigs were vaccinated with two doses, separated by three weeks, while a control group of 10 pigs received placebo (dummy treatment).
Danish: I en laboratorieundersøgelse med 40 svin blev 30 svin vaccineret med to doser med tre ugers mellemrum, mens en kontrolgruppe på 10 svin fik virkningsløs behandling (placebo).
English: Swine erysipelas is a bacterial disease of pigs characterised by sudden death, fever associated with diamond skin lesions, arthritis and by abortion in pregnant sows.
Danish: Svinerosen er en bakteriesygdom, der kendetegnes af pludselig død, feber forbundet med diamantformede hudforandringer, ledbetændelse og abort hos drægtige søer.
English: Why has Eryseng been approved?
Danish: Hvorfor blev Eryseng godkendt?
English: The measure of effectiveness was the percentage of vaccinated pigs free from specific (diamond shaped) skin lesions at the challenge site.
Danish: Virkningen blev vurderet efter den procentdel af de vaccinerede svin, der var uden specielle (diamantformede) forandringer af det udsatte område af huden.
English: Eryseng contains an adjuvant (aluminium hydroxide, DEAE-dextran and ginseng) to enhance the immune response.
Danish: Eryseng indeholder aluminiumhydroxid, DEAE-dextran og ginseng, der virker som adjuvans, dvs. forstærker immunreaktionen.
English: A second laboratory study involved 15 gilts (female pigs that have not yet had piglets) which were vaccinated according to the basic vaccination schedule with a booster dose six months later.
Danish: Endnu en laboratorieundersøgelse omfattede 15 gylte (ungsøer, der endnu ikke har fået grise), som blev vaccineret efter standardvaccinationsplanen med en forstærkningsdosis seks måneder senere.
English: What is Eryseng?
Danish: Hvad er Eryseng?
English: The first laboratory study showed 90% (27 out of 30) of vaccinated pigs were protected against Erysipelothrix rhusiopathiae serotype 1 remaining free of specific skin lesions whilst 93% (28 out of 30) of vaccinated pigs were protected against Erysipelothrix rhusiopathiae serotype 2 remaining free of specific skin lesions.
Danish: Den første laboratorieundersøgelse viste, at 90 % (27 ud af 30) at de vaccinerede svin var beskyttet mod Erysipelothrix rhusiopathiae serotype 1 og forblev fri for specielle hudforandringer, mens 93 % (28 ud af 30) af de vaccinerede svin var beskyttet mod Erysipelothrix rhusiopathiae serotype 2 og forblev fri for specielle hudforandringer.
English: What is Eryseng used for?
Danish: Hvad anvendes Eryseng til?
English: Eryseng is available as a suspension for injection.
Danish: Eryseng leveres som injektionsvæske, suspension.
English: The pigs were challenged a further six months later with injections of the bacteria Erysipelothrix rhusiopathiae serotypes 1 and 2 and the measure of effectiveness was the percentage of pigs protected by vaccination.
Danish: Svinene blev udsat for smitte yderligere seks måneder senere ved indsprøjtning af bakterierne Erysipelothrix rhusiopathiae serotype 1 og 2, og virkningen blev bedømt efter den procentdel af svinene, der var beskyttet af vaccinationen.
English: Eryseng is used to protect male and female pigs against swine erysipelas caused by Erysipelothrix rhusiopathiae bacteria of specific types called serotype 1 and serotype 2.
Danish: Eryseng anvendes til at beskytte han- og hungrise mod svinerosen (erysipelas) forårsaget af Erysipelothrix rhusiopathiae-bakterier af specifikke typer kaldet serotype 1 og serotype 2.
English: The second laboratory study showed 93% (14 out of 15) of pigs were protected against challenge with Erysipelothrix rhusiopathiae serotypes 1 and 2.
Danish: Den anden laboratorieundersøgelse viste, at 93 % (14 ud af 15) af svinene blev beskyttet mod udsættelse for Erysipelothrix rhusiopathiae serotype 1 og 2.
English: How has Eryseng been studied?
Danish: Hvordan blev Eryseng undersøgt?
English: All pigs were challenged 22 days after the second vaccination dose with injections of the bacteria Erysipelothrix rhusiopathiae serotypes 1 and 2.
Danish: Alle svinene blev 22 dage efter den anden vaccination udsat for bakterierne Erysipelothrix rhusiopathiae serotype 1 og 2.
English: Eryseng is a veterinary vaccine that contains inactivated (killed) Erysipelothrix rhusiopathiae bacteria.
Danish: Eryseng er en veterinær vaccine, der indeholder dræbte (inaktiverede) Erysipelothrix rhusiopathiaebakterier af stammen R32E11.
English: This will help protect them against swine erysipelas.
Danish: Derved opnås bedre beskyttelse mod svinerosen.
English: What benefit has Eryseng shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Eryseng?
English: How does Eryseng work?
Danish: Hvordan virker Eryseng?
English: 60 months.
Danish: 60 måneder.
English: Caution should be taken in such situations.
Danish: Der skal udvises forsigtighed i sådanne situationer.
English: • feel tired
Danish: • føle Dem træt
English: Forty patients were fully evaluable for response.
Danish: 40 patienter var fuldt evaluerbare for respons.
English: • You may lose hair (alopecia).
Danish: • De kan miste håret (alopeci).
English: - if you have any serious infections.
Danish: - hvis De har alvorlige infektioner.
English: Some of the symptoms or signs of extravasation may not be visible until several hours after it occurred.
Danish: Nogle af symptomerne eller tegnene på ekstravasation vil måske ikke være synlige før flere timer efter, det skete.
English: Appropriate aseptic techniques must be used.
Danish: Der skal anvendes passende aseptiske teknikker.
English: Your doctor will tell you how long your treatment lasts.
Danish: Lægen vil fortælle Dem, hvor længe Deres behandling vil vare.
English: BSA = Body Surface Area
Danish: BSA = Body Surface Area (legemsoverflade)
English: The length of your whole treatment period will depend on your progress and how well you feel.
Danish: Længden af hele Deres behandling vil afhænge af Deres forløb og af, hvor godt De befinder Dem.
English: Otherwise treatment must be delayed for up to 3 weeks until the criteria are met.
Danish: I modsat fald skal behandlingen udsættes i op til tre uger, indtil kriterierne er opfyldt.
English: Pregnant staff must be excluded from working with this medicinal product.
Danish: Gravide medarbejdere skal udelukkes fra at arbejde med dette lægemiddel.
English: Renal elimination of unchanged trabectedin in humans is low (less than 1%).
Danish: Den renale elimination af uændret trabectedin hos mennesker er lav (mindre end 1 %).
English: It will take 3 hours for the treatment of ovarian cancer.
Danish: Det vil tage tre timer i behandlingen af ovariekræft.
English: Long-term carcinogenicity studies have not been performed.
Danish: Der er ikke udført langvarige karcinogenicitetsstudier.
English: Other less serious side effects:
Danish: Andre mindre alvorlige bivirkninger:
English: In very severe cases this could lead to kidney failure.
Danish: I meget alvorlige tilfælde kan dette medføre nyresvigt.
English: No relevant differences in the safety profile were seen in this patient population.
Danish: Der blev ikke observeret relevante forskelle i sikkerhedsprofilen hos denne patientpopulation.
English: This value is approximately one-half the rate of human hepatic blood flow.
Danish: Denne værdi er cirka halvdelen af det hepatiske blod-flow hos mennesker.
English: A total of 76 Japanese patients were enrolled in the study, among which 73 patients were included in the final analysis set.
Danish: I alt 76 japanske patienter deltog i studiet, hvoraf 73 patienter blev medtaget i det endelige analysesæt.
English: You also may experience a darkening of the urine colour.
Danish: De kan også opleve en mørkfarvning af urinen.
English: Effects of other substances on trabectedin
Danish: Virkningen af andre stoffer på trabectedin
English: Additional anti-emetics may be administered as needed.
Danish: Yderligere antiemetika kan administreres efter behov.
English: The Pharmacovigilance and Risk Assessment Committee (PRAC) considered the results of the IAC report highly credible.
Danish: Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC - Pharmacovigilance and Risk Assessment Committee) betragtede resultaterne i IAC-rapporten som værende meget troværdige.
English: The same criteria as above must be met prior to re-treatment.
Danish: De samme kriterier som ovenfor skal være opfyldt inden genbehandling.
English: No significant differences were detected in overall survival (OS).
Danish: Der blev ikke påvist signifikante forskelle i den samlede overlevelse (overall survival - OS).
English: No specific studies in older people have been performed.
Danish: Der er ikke udført specifikke studier hos ældre personer.
English: It is possible for it to take a few days before the full extent of tissue damage is visible.
Danish: Det er muligt, at det tager nogle dage, før det fulde omfang af vævsskaden kan ses.
English: These signs could be indicative of the inability of the liver to perform its normal function.
Danish: Disse tegn kan tyde på, at leveren ikke kan udføre sine normale funktioner.
English: The secondary endpoints included objective response analysed using the RECIST and Choi criteria.
Danish: De sekundære endepunkter inkluderede objektiv respons analyseret ved anvendelse af RECIST- og Choi-kriterierne.
English: Independent radiology review, measurable disease *
Danish: Uafhængig radiologisk evaluering, målbar sygdom*
English: The relevance of this interaction e.g. central nervous system (CNS) toxicity has not been established.
Danish: Relevansen af denne interaktion, f.eks. centralnervesystem- (CNS)-toksicitet, er ikke blevet fastslået.
English: Calculate the required volume as follows:
Danish: Beregn den krævede mængde på følgende måde:
English: In some patients, a compartment syndrome can occur.
Danish: Hos visse patienter kan der opstå et kompartmentsyndrom.
English: You should not work with this medicine if you are pregnant.
Danish: De må ikke arbejde med denne medicin, hvis De er gravid.
English: CLS can be idiopathic (Clarkson's disease) or secondary to various conditions and treatments.
Danish: CLS kan være idiopatisk (Clarksons sygdom) eller sekundært til forskellige tilstande og behandlinger.
English: The same dose should be given for all cycles provided that no grade 3-4 toxicities are seen and that the patient fulfils the re-treatment criteria.
Danish: Der bør gives den samme dosis i alle cyklusser, forudsat at der ikke observeres grad 3-4-toksicitet, og forudsat at patienten opfylder kriterierne for genbehandling.
English: Prior to re-treatment, patients must fulfil the baseline criteria defined above.
Danish: Inden genbehandling skal patienterne opfylde de baselinekriterier, der er defineret ovenfor.
English: • If you have an allergic reaction (hypersensitivity).
Danish: • Hvis De får en allergisk reaktion (overfølsomhed).
English: • You may:
Danish: • De kan:
English: Therefore you must stop breast-feeding before you start your treatment and you must not begin breast-feeding again until your doctor has confirmed that it is safe to do so.
Danish: De skal derfor ophøre med at amme, før De påbegynder Deres behandling, og De må ikke begynde at amme igen, før lægen har bekræftet, at det er sikkert at gøre det.
English: Additional efficacy data are available from 3 single-arm Phase II trials with similar populations treated with the same regimen.
Danish: Yderligere effektdata er tilgængelige fra 3 enkelt-arm, fase II-studie med lignende populationer, behandlet med samme regime.
English: Creatinine clearance must be monitored prior to and during treatment.
Danish: Kreatininclearance skal monitoreres inden og under behandlingen.
English: • You may also have blood infections (sepsis) if your immune system is greatly compromised.
Danish: • De kan også få infektioner i blodet (sepsis), hvis deres immunsystem er meget svækket.
English: Treatment continued whilst clinical benefit was noted.
Danish: Behandlingen fortsatte så længe, der blev observeret kliniske fordele.
English: ALT and AST increases did not follow a cumulative pattern but showed a tendency towards less severe elevations over time.
Danish: ALAT- og ASAT-forhøjelser fulgte ikke et kumulativt mønster, men viste en tendens i retning af mindre forhøjelser over tid.
English: No statistically significant differences were found between treatment arms in global measures of Quality of Life.
Danish: Der blev ikke fundet statistisk signifikante forskelle mellem behandlingsarmene i globale målinger af livskvalitet.
English: Allergic Reactions
Danish: Allergiske reaktioner
English: • You may experience headache and sleeping problems.
Danish: • De kan opleve hovedpine og søvnproblemer.
English: You should seek medical attention immediately if any of the following conditions appear:
Danish: De skal omgående søge lægehjælp, hvis ét af følgende sker:
English: The requirements for submission of periodic safety update reports of this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: The main secondary endpoints are summarized in the table below:
Danish: De vigtigste sekundære endepunkter er opsummeret i tabellen nedenfor:
English: The frequencies are classified as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1000).
Danish: Hyppigheden er klassificeret som meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100) og sjælden (≥1/10.000 til <1/1.000).
English: The excretion of trabectedin in milk has not been studied in animals.
Danish: Udskillelse af trabectedin i mælken er ikke blevet undersøgt hos dyr.
English: The primary analysis of progression free survival (PFS) was performed in 645 patients with measurable disease and assessed by independent radiology review.
Danish: Den primære analyse af progressionsfri overlevelse (progression free survival - PFS) blev udført hos 645 patienter med målbar sygdom og vurderet ved uafhængig, radiologisk evaluering.
English: Extravasation should be managed by local standard practice.
Danish: Ekstravasation bør håndteres i henhold til lokal standardpraksis.
English: The terminal half-life is long (population value of the terminal elimination phase: 180-hr).
Danish: Den terminale halveringstid er lang (populationsværdien af den terminale eliminationsfase er 180 timer).
English: • You could have an allergic reaction.
Danish: • De kan får en allergisk reaktion.
English: The benefit in OS with Yondelis plus PLD was not due to the effect of subsequent therapies, which were well balanced between the two treatment arms.
Danish: Fordelen i OS med Yondelis plus PLD skyldtes ikke effekten af efterfølgende behandlinger, som var velbalanceret mellem de to behandlingsarme.
English: Trabectedin is genotoxic both in vitro and in vivo.
Danish: Trabectedin er genotoksisk både in vitro og in vivo.
English: Store in a refrigerator (2ºC - 8ºC).
Danish: Opbevares i køleskab (2 ºC - 8 ºC).
English: During your treatment with Yondelis you may feel tired and experience a loss of strength.
Danish: Under Deres behandling med Yondelis kan De føle Dem træt og opleve tab af styrke.
English: The powder has a white to off-white colour and comes in a glass vial.
Danish: Pulveret har en hvid til offwhite farve og leveres i et hætteglas.
English: Neutropenic infection Sepsis
Danish: Neutropenisk infektion Sepsis
English: The 3 assessors are independent, have no conflict of interest, are all specialists on CLS, and they provided a relevant description of their methodology and criteria, a distinction between possible and probable CLS and for the probable CLS cases, that are fatal, an evaluation of trabectedin causality.
Danish: De 3 assessorer er uafhængige, har ingen interessekonflikter, er alle specialister inden for CLS, og de tilvejebragte en relevant beskrivelse af deres metodologi og kriterier, en skelnen mellem mulig og sandsynlig CLS og for de sandsynlige CLS-tilfælde, som havde dødelig udgang, en evaluering af trabectedinkausaliteten.
English: Information on in-use stability of the reconstituted and diluted solutions is included in the section for medical and healthcare professionals.
Danish: Information om stabiliteten af de opløste og fortyndede opløsninger under brug findes i afsnittet til læger og sundhedspersonale.
English: Pharmacotherapeutic group: Antineoplastic agent, ATC code: L01CX01.
Danish: Farmakoterapeutisk klassifikation: Antineoplastisk middel, ATC-kode: L01CX01.
English: Genetic counselling is also recommended for patients wishing to have children after therapy.
Danish: Genetisk rådgivning anbefales også for patienter, der ønsker at få børn efter behandlingen.
English: • You could also feel pain in your muscles (myalgia).
Danish: • De kan også få ondt i musklerne (myalgi).
English: No studies on the effects of the ability to drive and to use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj og betjene maskiner.