FrancophonIA/ELRC3.0 huggingface dataset:
English: Trydonis has been shown to be effective at relieving symptoms of COPD in three main studies involving over 5,500 patients whose symptoms were not controlled well enough either by combinations of two other COPD medicines or by a muscarinic receptor antagonist alone.
Danish: Trydonis har vist sig effektivt til at lindre symptomerne på KOL i tre hovedstudier med over 5.500 patienter, hvis symptomer ikke var tilstrækkeligt kontrolleret med enten en kombination af to andre KOL-lægemidler eller med en muskarinreceptorantagonist alene.
English: Trydonis is effective at reducing the frequency of exacerbations and improving lung function of patients with COPD.
Danish: Trydonis er effektivt til at nedsætte hyppigheden af symptomforværringer og forbedre lungefunktionen hos patienter med KOL.
English: Trydonis is used for maintenance (continuing) treatment in patients whose disease is not adequately controlled despite treatment with a combination of two COPD medicines consisting of a long-acting beta-2 agonist plus either an inhaled corticosteroid or a long-acting muscarinic receptor antagonist.
Danish: Trydonis anvendes til vedligeholdelsesbehandling (løbende behandling) af patienter, hvis sygdom ikke er tilstrækkeligt kontrolleret på trods af behandling med en kombination af to KOL-lægemidler bestående af en beta-2-agonist plus enten et inhaleret kortikosteroid eller en langtidsvirkende muskarinantagonist.
English: The three active substances in Trydonis work in different ways to reduce inflammation and keep the airways open, allowing the patient to breathe more easily.
Danish: De tre aktive stoffer i Trydonis virker på forskellige måder ved at reducere betændelsestilstande og holde luftvejene åbne, hvilket gør det lettere for patienten at trække vejret.
English: How is Trydonis used?
Danish: Hvordan anvendes Trydonis?
English: In the second study lasting a year, patients treated with Trydonis had 20% fewer exacerbations (flareups of symptoms) per year than patients treated with tiotropium (a long-acting muscarinic receptor antagonist).
Danish: I det andet studie, der varede et år, havde de patienter, der blev behandlet med Trydonis, 20 % færre symptomforværringer om året end de patienter, der blev behandlet med tiotropium (en langtidsvirkende muskarinreceptorantagonist).
English: In the third study lasting a year, patients treated with Trydonis had 15% fewer exacerbations a year than patients treated with a combination of indacaterol (a long-acting beta-2 agonist) and glycopyrronium bromide.
Danish: I det tredje studie, der varede et år, havde de patienter, der blev behandlet med Trydonis, 15 % færre symptomforværringer om året end de patienter, der blev behandlet med en kombination af indacaterol (en langtidsvirkende beta-2-agonist) og glycopyrroniumbromid.
English: What benefits of Trydonis have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Trydonis?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trydonis 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 Trydonis.
English: Because these receptors help control the contraction of the airway muscles, blocking them causes the muscles to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Danish: Da disse receptorer er med til at styre muskelsammentrækningen, vil blokeringen af dem få musklerne i luftvejene til at slappe af, hvorved luftvejene holdes åbne, og patienten får lettere ved at trække vejret.
English: How does Trydonis work?
Danish: Hvordan virker Trydonis?
English: By attaching to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Danish: Ved at binde sig til receptorerne får det musklerne til at slappe af, så luftvejene holdes frie og patienten lettere kan trække vejret.
English: This summary was last updated in 05-2015.
Danish: Dette sammendrag blev sidst ajourført i 03-2015.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fasturtec on 23 February 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Dutrebis den 26. marts 2015.
English: The full EPAR for Fasturtec can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Dutrebis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Fasturtec.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Dutrebis.
English: Other information about Fasturtec
Danish: Andre oplysninger om Dutrebis
English: For more information about treatment with Fasturtec, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Dutrebis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What is the risk associated with Fasturtec?
Danish: Hvilke risici er der forbundet med Dutrebis?
English: Why has Fasturtec been approved?
Danish: Hvorfor blev Dutrebis godkendt?
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 Fasturtec.
Danish: Det forklarer, hvordan agenturet vurderede lægemidlet for at kunne anbefale udstedelse af en markedsføringstilladelse i EU og fastlægge anvendelsesbetingelserne.
English: What benefit has Fasturtec shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Dutrebis?
English: How is Fasturtec used?
Danish: Hvordan anvendes Dutrebis?
English: The CHMP decided that Fasturtec's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Dutrebis opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What is Fasturtec used for?
Danish: Hvad er Dutrebis, og hvad anvendes det til?
English: Fasturtec rasburicase
Danish: Dutrebis lamivudin/raltegravir
English: For the full list of all side effects reported with Fasturtec, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Dutrebis fremgår af indlægssedlen.
English: The most common side effects with Fasturtec (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, headache, fever and diarrhoea.
Danish: De hyppigste bivirkninger med lamivudin og raltegravir (som optræder hos mere end 1 ud af 10 personer) er hovedpine og kvalme.
English: Fasturtec is a medicine that contains the active substance rasburicase.
Danish: Dutrebis indeholder de aktive stoffer lamivudin og raltegravir.
English: Fasturtec must not be used in patients with a deficiency in (low levels of) glucose 6 phosphate dehydrogenase (G6PD) or other metabolic disorders known to cause haemolytic anaemia (low haemoglobin levels caused by the abnormal breakdown of red blood cells).
Danish: Dutrebis er et lægemiddel til behandling af patienter, der er smittet med humant immundefektvirus type 1 (hiv-1), som er årsag til erhvervet immundefektsyndrom (aids).
English: This helps to reduce the levels of uric acid in the blood, thereby reducing the load on the kidney and preventing any damage.
Danish: Ved at blokere dette enzym mindsker Dutrebis hiv-indholdet i blodet og holder det på et lavt niveau.
English: Fasturtec treatment should be supervised by a doctor who has been trained in the use of chemotherapy for blood cancers.
Danish: Dutrebis udleveres kun efter recept, og behandlingen bør ordineres af en læge med erfaring i behandling af hiv-infektion.
English: The active substance in Fasturtec, rasburicase, is an enzyme called urate oxidase, which transforms uric acid into another chemical called allantoin, which can easily be excreted by the kidneys in the urine.
Danish: Det ene aktive stof, lamivudin, er en nukleosid revers transkriptasehæmmer (NRTI).
English: How does Fasturtec work?
Danish: Hvordan virker Dutrebis?
English: The medicine can only be obtained with a prescription.
Danish: De nærmere oplysninger fremgår af indlægssedlen.
English: The enzyme was originally extracted from a fungus, but in Fasturtec it is produced by a method known as ‘recombinant DNA technology': it is made by a yeast into which a gene (DNA) has been introduced that makes it able to produce urate oxidase.
Danish: Det virker ved at blokere revers transkriptase, et enzym, som hiv bruger til at fremskaffe den genetiske information, der skal til for at danne flere vira, når først cellen er angrebet.
English: The benefits of Fasturtec were first studied in three main studies involving a total of 293 patients, including adults and children.
Danish: Virksomheden fremlagde derfor data fra de undersøgelser, der blev anvendt ved godkendelsen af disse lægemidler, herunder en undersøgelse omfattende 160 patienter, der fik raltegravir med lamivudin (plus endnu et hiv-lægemiddel, tenofovir) i sammenlagt 240 uger.
English: The recommended dose is 0.2 mg per kilogram body weight in both children and adults, given as a daily infusion for up to seven days.
Danish: Det anvendes sammen med andre hiv-lægemidler hos patienter fra 6 års-alderen, som vejer mindst 30 kg.
English: Fasturtec was not compared with another medicine in this study.
Danish: Dutrebis skal anvendes i kombination med andre hiv-lægemidler.
English: The dose-finding studies showed that, after 48 hours, Fasturtec at a daily dose of 0.2 mg per kg reduced the uric acid levels to normal in 95% of patients.
Danish: Behandlingens virkning blev hovedsagelig bedømt på andelen af patienter, der fik nedsat virusindholdet i blodet til færre end 50 kopier af hiv-RNA pr. ml.
English: Two of the studies were designed to define the best dose to use.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Dutrebis anvendes så sikkert som muligt.
English: Patients undergoing chemotherapy may be at risk of rapid tumour lysis, where many cancer cells are broken down at once causing a sudden rise of uric acid in the blood which can cause damage to the kidneys.
Danish: For raltegravir var der en lille forskel i den optagne mængde, men Dutrebis frembragte en mængde raltegravir, der var lige så effektiv til at kontrollere virusset.
English: Fasturtec is used to treat and prevent high levels of uric acid in the blood in order to prevent kidney failure.
Danish: Lamivudin og raltegravir er i forvejen godkendt hver for sig til behandling af hiv-infektion.
English: 1adjuvanted by AS04C containing: - 3-O-desacyl-4'- monophosphoryl lipid A (MPL) 2
Danish: 1adjuveret af AS04C indeholdende: - 3-O-desacyl-4'- monophosphoryl lipid A (MPL) 2
English: 1 dose (0.5 ml) contains: Hepatitis B surface antigen 1, 2, 3
Danish: 1 dosis (0,5 ml) indeholder: Hepatitis B overflade antigen 1, 2, 3
English: 2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
Danish: 2adsorberet til aluminiumphosphat (0,5 milligram Al3+ totalt) 3produceret på gærceller (Saccharomyces cerevisae) vha. rekombinant DNA-teknologi
English: Content (concentration)
Danish: Lægemiddelform Indgivelsesvej Emballage Indhold (koncentration)
English: Overall summary of the scientific evaluation of Nanotop and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Nanotop og relaterede navne (se bilag I)
English: • The Committee considered the notification of the referral triggered by the Germany under Article 29(4) of Directive 2001/83/EC;
Danish: • udvalget behandlede meddelelsen om den indbringelse, der var indledt af Tyskland i medfør af artikel 29, stk. 4, i direktiv 2001/83/EF,
English: On the other hand, if the particles are too large they would mostly remain trapped at the injection site and need too much time for transition to the lymph nodes, which is not practical.
Danish: Hvis partiklerne på den anden side er for store, vil de for størstedelen forblive opfanget på injektionsstedet og behøver for lang tid til at gå over i lymfeknuderne, hvilket ikke er praktisk.
English: The data provided by the MAH support the notion that variability may decrease when batches are analysed over a shorter period of time.
Danish: De af markedsføringstilladelsesindehaveren fremlagte data støtter opfattelsen af, at variabiliteten kan aftage, når batcherne analyseres i løbet af en kortere tidsperiode.
English: The MAH argued that the fluctuations per se are not clinically relevant and therefore differences between such fluctuations are not likely to pose a risk to public health.
Danish: Indehaveren af markedsføringstilladelsen hævdede, at fluktuationerne i sig selv ikke er klinisk relevante, og at forskelle mellem sådanne fluktuationer derfor ikke forventes at medføre risiko for den offentlige sundhed.
English: The qualitative and quantitative composition of the medicinal product Nanotop was shown to be the same in comparison to the comparator product Nanocoll.
Danish: Den kvalitative og kvantitative sammensætning af lægemidlet Nanotop blev påvist at være den samme som af sammenligningsproduktet Nanocoll.
English: The mutual recognition marketing authorisation application (MAA) for Nanotop 0.5 mg, kit for radiopharmaceutical preparation / lyophilisate for suspension for injection was submitted on the basis of the marketing authorisation granted by Germany on 8th December 2011.
Danish: Ansøgningen om markedsføringstilladelse efter den gensidige anerkendelsesprocedure for Nanotop, radiofarmaceutisk præparationssæt / lyofilisat til injektionsvæske, suspension, 0,5 mg, blev indgivet på grundlag af den markedsføringstilladelse, der var udstedt af Tyskland den 8. december 2011.
English: If the subcutaneously injected particles are too small they “run” through the lymphatic system too quickly and disappear before imaging techniques can be applied.
Danish: Hvis de subkutant injicerede partikler er for små, gennemløber de lymfesystemet for hurtigt og forsvinder, før der kan anvendes i billeddannelsesteknik.
English: There have been no studies so far investigating the clinical effects of variability occurring within the particle size range of HSA nanocolloid (of 0 to 80 nm).
Danish: Der er hidtil ikke udført undersøgelser af de kliniske virkninger af variabilitet i partikelstørrelsesfordelingen af HSA-nanokolloid (på 0 til 80 nm).
English: In addition the MAH has provided data on Nanocoll and Nanotop batches that were analysed on four days (six batches), and on the same day.
Danish: Desuden har indehaveren af markedsføringstilladelsen fremlagt data om batcher af Nanocoll og Nanotop, der var analyseret i løbet af 4 dage (6 batcher) og på samme dag.
English: The relevant quality attributes including upper particle size limits are defined in the European core summary of product characteristics (SmPC) for Tc-99m Albumin Microcolloid (nm), in the relevant European and national Treatment Guidelines1,2,3 and in the SmPC of the approved products (e.g. Nanocoll) and have been cited by the MAH.
Danish: De relevante kvalitetsegenskaber, herunder øvre partikelstørrelsesgrænser, er fastlagt i det europæiske kerneproduktresumé for Tc-99m albumin-mikrokolloid (nm), i de relevante europæiske og nationale behandlingsretningslinjer 1,2,3 og i produktresuméet for de godkendte produkter (f.eks. Nanocoll) og er blevet citeret af indehaveren af markedsføringstilladelsen.
English: The particle size range is in this respect the crucial parameter that characterises the particular compound since small-sized colloids allow identification of a greater number of sentinel lymph nodes with a high statistical significance4.
Danish: Partikelstørrelsesfordelingen er i denne henseende den afgørende parameter til karakterisering af det pågældende stof, da små kolloider giver mulighed for identifikation af et større antal sentinel lymph nodes med høj statistisk signifikans4.
English: During the CMDh referral procedure that followed, no consensus could be reached as Sweden maintained their objection that the importance of the batch variability for the distribution and uptake of Nanotop in lymph nodes, as well as its clinical implications had not been adequately addressed, as even a small difference in efficacy could represent a potential serious risk to public health.
Danish: Under den efterfølgende indbringelsesprocedure for CMDh kunne der ikke opnås enighed, da Sverige fastholdt sin indvending om, at der ikke var taget tilstrækkeligt hensyn til batchvariabilitetens betydning for fordelingen og optagelsen af Nanotop i lymfeknuder og de kliniske implikationer heraf, idet selv en lille forskel i virkning kunne udgøre en potentiel alvorlig risiko for den offentlige sundhed.
English: the CHMP has recommended the granting of the marketing authorisation for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III of this Opinion for Nanotop and associated names (see Annex I).
Danish: anbefalede CHMP udstedelse af markedsføringstilladelse, for hvilken produktresuméet, etiketteringen og indlægssedlen er uændrede svarende til endelige version, der er fastlagt ved behandlingen i koordinationsgruppen som anført i bilag III til denne udtalelse for Nanotop og relaterede navne (se bilag I).
English: During development the MAH looked into the size distribution below 80 nm and created “particle size groups”.
Danish: I udviklingsfasen undersøgte indehaveren af markedsføringstilladelsen størrelsesfordelingen under 80 nm og fastlagde “partikelstørrelsesgrupper”.
English: The legal basis for the submitted marketing authorisation application (MAA) was Article 10a "well established use", relying on appropriate scientific literature data of another similar product, Nanocoll.
Danish: Det retlige grundlag for ansøgningen om markedsføringstilladelse var artikel 10, litra a), “almindelig anerkendt anvendelse”, baseret på en udførlig videnskabelig bibliografi for et andet produkt, Nanocoll.
English: Filters at 15 nm, 30 nm, 50 nm and 80 nm filter pore size were used.
Danish: Der blev anvendt filtre med porestørrelse 15 nm, 30 nm, 50 nm og 80 nm. Partikelstørrelsesområdet af Nanotop svarer til Nanocoll.
English: The upper particle size limits for SLN detection procedures used in Europe has been established and the acceptance criterion of at least 95% of particles having a diameter ≤ 80 nm was shown to be met by all batches of Nanotop.
Danish: De i Europa anvendte øvre partikelstørrelsesgrænser til detektion af sentinel lymph nodes er fastlagt, og acceptkriteriet om, at mindst 95 % af partiklerne har en diameter ≤ 80 nm, blev påvist at være opfyldt af alle batcher af Nanotop.
English: During the mutual recognition procedure (MRP), major concerns were raised by the member states Sweden and France, that considering the batch variability, it was not possible from a quality perspective to conclude about the comparability between Nanotop and Nanocoll.
Danish: Under den gensidige anerkendelsesprocedure blev der af medlemsstaterne Sverige og Frankrig rejst væsentlig betænkelighed ved, at det i betragtning af batchvariabiliteten ikke var muligt at drage kvalitetsmæssige konklusioner om sammenligneligheden af Nanotop og Nanocoll.
English: Nanotop is a diagnostic radiopharmaceutical kit containing denatured human serum albumin (HSA), which after radiolabelling with Sodium Pertechnetate (99mTc) solution results in Technetium (99mTc) Nanocolloid.
Danish: Nanotop er et radiofarmaceutisk diagnostisk præparationssæt, der indeholder denatureret humant serumalbumin (HSA), som efter radioaktiv mærkning med en opløsning af natriumpertechnetat (99mTc) danner et technetium- (99mTc-) nanokolloid.
English: In addition the MAH's clinical expert states that any variability in particle size within the specified range of Nanotop (≤ 80 nm of at least 95% of the particles) is not relevant for the clinical outcome.
Danish: Desuden erklærer markedsføringstilladelsesindehaverens kliniske ekspert, at en eventuel variabilitet i partikelstørrelse inden for det specificerede område af Nanotop (≤ 80 nm for mindst 95 % af partiklerne) ikke er relevant for det kliniske udfald.
English: Considering the particle size and the particle size ranges range discussed above, the CHMP was of the view that Nanotop is comparable to Nanocoll - the product referred to in the submitted literature, and that therefore an impact on clinical efficacy is not expected.
Danish: I betragtning af ovenstående drøftelse af partikelstørrelse og partikelstørrelsesområder var CHMP af den opfattelse, at Nanotop er sammenligneligt med Nanocoll - det produkt, der er omhandlet i den forelagte litteratur - og at der derfor ikke forventes indflydelse på den kliniske virkning.
English: The EANM and SNMMI practice guideline for lymphoscintrigraphy and sentinel node localization in breast cancer.
Danish: Giammarile et al. The EANM and SNMMI practice guideline for lymphoscintrigraphy and sentinel node localization in breast cancer.
English: Due to different views in the interpretation of the data related to particle size distribution within the defined limits relevant for efficacy, this referral was triggered to assess the importance of the batch to batch variability for the distribution and uptake of Nanotop in lymph nodes, and whether this could have an impact on efficacy.
Danish: På grund af meningsforskelle i fortolkningen af dataene om partikelstørrelsesfordeling inden for de fastlagte grænser med relevans for virkningen blev denne indbringelse udløst med henblik på at vurdere batch-til-batch variabilitetens betydning for fordeling og optagelse af Nanotop i lymfeknuder, og hvorvidt dette kunne have betydning for virkningen.
English: In response to the objection that there is a difference in the data fluctuation between Nanotop and Nanocoll, the MAH has provided data to show that the fluctuations observed are comparable and that particle size group distribution is comparable between Nanotop and Nanocoll.
Danish: Som svar på indvendingen om, at der er forskel i datafluktuation mellem Nanotop og Nanocoll, har indehaveren af markedsføringstilladelsen fremlagt data til påvisning af, at de observerede fluktuationer er sammenlignelige, og at partikelstørrelsesgruppefordelingen er sammenlignelig mellem Nanotop og Nanocoll.
English: Technetium (99mTc) Nanocolloid is used for characterisation of the properties of the lymphatic system and in particular sentinel lymph node (SLN) detection in breast cancer and malignant melanoma.
Danish: Technetium- (99mTc-) nanokolloid anvendes til karakterisering af lymfesystemets egenskaber, navnlig til detektion af “skildvagtlymfeknuder” (sentinel lymph nodes) ved brystcancer og malignt melanom.
English: The MAH has discussed particle size ranges and its implication for clinical practice in general, with reference to clinical guidelines.
Danish: Indehaveren af markedsføringstilladelsen har gennemgået partikelstørrelsesområder og deres generelle betydning i klinisk praksis med henvisning til kliniske retningslinjer.