FrancophonIA/ELRC3.0 huggingface dataset:
English: titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172).
Danish: (E322), titandioxid (E171), jernoxid, rød (E172) og jernoxid, gul (E172).
English: • Drowsiness
Danish: • Tømmermænd
English: The principal metabolite is 6-sulfatoxy-melatonin (6-S-MT), which is inactive.
Danish: Metaboliseringen af melatonin falder med alderen, og den præpubertale og pubertale metabolisering er hurtigere end ved højere alder. Hovedmetabolitten er 6-sulfatoxymelatonin (6-S-MT), som er inaktiv.
English: Slenyto 1 mg prolonged-release tablets
Danish: Slenyto, depottabletter, 1 mg
English: Slenyto 5 mg prolonged-release tablets Yellow, film coated, round, biconvex, 3 mm diameter tablets with no imprint.
Danish: Gule, filmovertrukne, runde, bikonvekse tabletter, diameter 3 mm, uden præg.
English: Slenyto 1 mg prolonged-release tablets Pink, film coated, round, biconvex, 3 mm diameter tablets with no imprint.
Danish: Lyserøde, filmovertrukne, runde, bikonvekse tabletter, diameter 3 mm, uden præg.
English: - The other ingredients are ammonio methacrylate copolymer type A, calcium hydrogen phosphate dihydrate, lactose monohydrate, silica (colloidal anhydrous), magnesium stearate,
Danish: - De øvrige indholdsstoffer er ammoniummethacrylat-copolymer type A,
English: NAME OF THE MEDICINAL PRODUCT Slenyto 1 mg prolonged-release tablets
Danish: LÆGEMIDLETS NAVN Slenyto, depottabletter, 1 mg Slenyto, depottabletter, 5 mg
English: • Skin lesion
Danish: • Næseblod
English: • Visual impairment
Danish: • Synsnedsættelse
English: The dose can be repeated.
Danish: Indsprøjtningen kan gentages.
English: The European Commission granted a marketing authorisation valid throughout the European Union for SonoVue on 26 March 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for SonoVue den 26. marts 2001.
English: The full EPAR for SonoVue can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for SonoVue findes på agenturets websted under: website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Side-effects were generally minor.
Danish: Bivirkningerne var generelt milde.
English: This is a summary of the European public assessment report (EPAR) for SonoVue.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for SonoVue.
English: SonoVue sulphur hexafluoride
Danish: SonoVue sulphurhexafluorid
English: Other information about SonoVue
Danish: Andre oplysninger om SonoVue
English: SonoVue is used in:
Danish: SonoVue anvendes ved:
English: What measures are being taken to ensure the safe and effective use of SonoVue?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af SonoVue?
English: For use in echocardiography, SonoVue was investigated in 3 main studies.
Danish: Hvad angår anvendelsen til ekkokardiografi, blev SonoVue undersøgt i tre hovedundersøgelser.
English: • Doppler (a diagnostic test that measures the speed of blood flow).
Danish: • Doppler (en diagnostisk undersøgelse til måling af blodets strømningshastighed).
English: It is only used when the results of the test without a contrast agent are inconclusive.
Danish: Det anvendes kun, når undersøgelse uden kontraststof ikke giver et klart resultat.
English: It is a contrast agent (it helps make internal body structures visible during imaging tests).
Danish: Det er et kontraststof (som medvirker til at synliggøre kroppens indre opbygning ved billeddannende undersøgelser).
English: The gas is removed naturally from the blood through the lungs or passed out in the urine after bladder scans.
Danish: Gassen fjernes naturligt fra blodet gennem lungerne eller udskilles i urinen efter blærescanningerne.
English: Pooled analysis of the studies suggested that SonoVue identified children with vesicoureteral reflux in 89% of cases, and correctly distinguished patients who did not have the condition in 81% of cases.
Danish: Samlede analyser af undersøgelserne viste, at man med SonoVue kunne identificere børn med vesikoureteral refluks i 89 % af tilfældene, og at man kunne udskille de patienter, der ikke havde tilstanden, korrekt i 81 % af tilfældene.
English: SonoVue is a medicine for diagnostic use only.
Danish: SonoVue er et lægemiddel, der kun er til diagnostisk brug.
English: Why is SonoVue approved?
Danish: Hvorfor blev SonoVue godkendt?
English: What is SonoVue and what is it used for?
Danish: Hvad er SonoVue, og hvad anvendes det til?
English: The company also presented results from the literature of 4 main studies involving over 500 children given SonoVue before ultrasound scans of the bladder to detect vesicoureteral reflux.
Danish: Virksomheden fremlagde også resultater fra litteraturen for fire hovedundersøgelser, der omfattede over 500 børn, som fik SonoVue før ultralydsscanninger af blæren for at opdage vesikoureteral refluks.
English: • echocardiography (a diagnostic test where an image of the heart is obtained).
Danish: • ekkokardiografi (en undersøgelse, hvor hjertet afbildes).
English: However, the results were not sufficient to state that a negative result following ultrasound with Sonovue allows the practitioner to exclude a diagnosis of vesicoureteral reflux.
Danish: Resultaterne var dog ikke tilstrækkelige til at hævde, at et negativt resultat efter ultralyd med SonoVue gør det muligt for lægen at udelukke en diagnose på vesikoureteral refluks.
English: The European Medicines Agency therefore decided that SonoVue's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved SonoVue opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for SonoVue.
English: The medicine contains the active substance sulphur hexafluoride (a gas).
Danish: Lægemidlet indeholder det aktive stof sulphurhexafluorid (en gas).
English: The main measure of effectiveness was how clear the images obtained in the test were.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor tydelige billeder der kom ud af undersøgelserne.
English: The active substance in SonoVue, sulphur hexafluoride, is a gas that is not soluble in body fluids or water.
Danish: Det aktive stof i SonoVue, sulphurhexafluorid, er en gas, der er uopløselig i kropsvæsker eller vand.
English: SonoVue must also not be used together with the medicine dobutamine (used for heart failure) in patients for whom dobutamine is not suitable.
Danish: SonoVue må heller ikke anvendes sammen med lægemidlet dobutamin (som bruges mod hjertesvigt) hos patienter, der ikke må tage dobutamin.
English: For more information about treatment with SonoVue, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med SonoVue, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: SonoVue is used in tests that measure how ultrasound travels within the body because it improves the ability to create an echo.
Danish: SonoVue anvendes til undersøgelser af, hvordan ultralyd bevæger sig i kroppen, da det forstærker evnen til at danne ekko.
English: What are the risks associated with SonoVue?
Danish: Hvilke risici er der forbundet med SonoVue?
English: Ultrasound with SonoVue was compared with the standard method using X-rays with an X-ray contrast agent.
Danish: Ultralyd med SonoVue blev sammenlignet med standardmetoden, hvor der anvendes røntgenstråler med et røntgenkontraststof.
English: After injection, the microbubbles travel in the blood or disperse throughout the bladder, where they reflect ultrasound waves more than the surrounding tissues.
Danish: Efter indsprøjtningen vandrer mikroboblerne rundt i blodet eller spredes i hele blæren, hvor de tilbagekaster ultralyd bedre end det omgivende væv.
English: It is not intended to provide practical advice on how to use SonoVue.
Danish: Det er ikke en praktisk vejledning i, hvordan SonoVue bør anvendes.
English: No side effects attributable to the medicine have been reported in children given SonoVue into the bladder.
Danish: Der er ikke rapporteret nogen bivirkninger, som kan tilskrives lægemidlet, hos børn, der fik SonoVue indgivet i blæren.
English: • ultrasound scans of the bladder and urinary tract in children and adolescents to detect vesicoureteral reflux, a condition in which urine flows backward from the bladder to the kidneys, leading to scarring and kidney infections.
Danish: • ultralydsscanninger af blæren og urinvejene hos børn og unge for at opdage vesikoureteral refluks (tilbagestrømning af urin), som er en tilstand, hvor urinen strømmer tilbage fra blæren til nyrerne, hvilket fører til ardannelse og nyreinfektioner.
English: In these studies, SonoVue was not compared with any other medicine, but the results of the test with SonoVue were compared with the ‘gold standard', such as angiography (X-rays of blood vessels).
Danish: I disse undersøgelser blev SonoVue ikke sammenlignet med andre lægemidler, men undersøgelsesresultaterne med SonoVue blev sammenholdt med bedste standard som f.eks. angiografi (røntgenundersøgelse af blodkarrene).
English: For use in Doppler scans, a further 3 main studies involved 361 patients who were being tested for abnormalities in large blood vessels, and 217 patients being tested for abnormalities in smaller vessels.
Danish: Hvad angår anvendelsen til Doppler-scanninger, omfattede tre yderligere hovedundersøgelser 361 patienter, der blev undersøgt for forandringer i store blodkar, og 217 patienter, der blev undersøgt for forandringer i mindre blodkar.
English: SonoVue can only be obtained with a prescription and should only be used by doctors who have experience in diagnostic ultrasound imaging.
Danish: SonoVue udleveres kun efter recept og bør kun anvendes af læger med erfaring i diagnostisk ultralydsscanning.
English: SonoVue has been shown to be effective in improving ultrasound scans of the heart in adults and the bladder in children, and in measurements of blood flow.
Danish: SonoVue har vist sig at være effektivt til at forbedre ultralydsscanninger af hjertet hos voksne og blæren hos børn og til at måle blodgennemstrømningen.
English: SonoVue must not be injected into a vein in patients known to have right-to-left shunts (abnormal movement of blood within the heart), severe pulmonary hypertension (high blood pressure in the pulmonary artery, the blood vessel that leads from the heart to the lungs), uncontrolled hypertension (high blood pressure) or adult respiratory distress syndrome (severe fluid build-up in both lungs).
Danish: SonoVue må ikke indsprøjtes i en vene hos patienter, som vides at have højre-venstre shunt (unormal blodtransport i hjertet), svært forhøjet blodtryk i lungepulsåren (det kar, der fører fra hjertet til lungerne), ukontrolleret forhøjet blodtryk eller Adult Respiratory Distress Syndrome (svær ophobning af vand i begge lunger).
English: The most common side effects when SonoVue is injected into a vein (seen in up to 1 in 100 patients) are headache, nausea (feeling sick) and reactions at the injection site.
Danish: De hyppigste bivirkninger (som optræder hos op til 1 ud af 100 patienter), når SonoVue indsprøjtes i en åre, er hovedpine, kvalme og reaktioner på injektionsstedet.
English: The ultrasound scan of the bladder and kidneys is carried out during filling and emptying of the bladder.
Danish: Ultralydsscanningen af blæren og nyrerne foretages, når blæren fyldes og tømmes.
English: It is used to obtain a clearer scan of the chambers of the heart, especially of the left ventricle, in adults with suspected or confirmed coronary artery disease;
Danish: Det anvendes for at få et tydeligere scan af hjertekamrene, navnlig venstre hjertekammer, hos voksne, som antages eller vides at have sygdom i kranspulsårerne
English: When used with ultrasound of the heart or for measuring blood flow, SonoVue is injected intravenously (into a vein) before the test is carried out, as a 2 or 2.4 ml dose depending on which test is being carried out.
Danish: Hvis SonoVue anvendes i forbindelse med en ultralydsscanning af hjertet eller til måling af blodgennemstrømningen, gives det før undersøgelsen ved indsprøjtning i en vene i en mængde på 2 eller 2,4 ml, alt afhængigt af den pågældende undersøgelse.
English: However, this was not observed in the pancreas, kidney, ovary or prostate gland.
Danish: Det samme blev imidlertid ikke iagttaget i bugspytkirtel, nyrer, æggeledere eller blærehalskirtel.
English: It is available as a kit including one vial of gas and powder and one pre-filled syringe containing 5 ml of solvent.
Danish: Det leveres som et sæt bestående af et hætteglas med gas og pulver samt en fyldt sprøjte med 5 ml solvens (opløsningsvæske).
English: SonoVue was more effective than the comparator and than placebo in improving the clarity of the image obtained of the left ventricle and left ventricle border.
Danish: SonoVue var mere effektivt end sammenligningslægemidlet og placebo til at forbedre klarheden af billedet af venstre hjertekammer og randen af venstre hjertekammer.
English: When SonoVue is made up into a suspension, the gas is trapped in tiny bubbles called microbubbles.
Danish: Når SonoVue er bragt i opslæmning, er gassen til stede som ganske små bobler, der kaldes mikrobobler.
English: The company will carry out a study to confirm the effectiveness of SonoVue in detecting vesicoureteral reflux in children and its impact on the way patients are managed.
Danish: Virksomheden vil udføre en undersøgelse for at bekræfte, at SonoVue er effektivt til opdagelse af vesikoureteral refluks hos børn, og for at bekræfte SonoVues indvirkning på behandlingen af patienterne.
English: SonoVue can be used in adults for Doppler tests for large blood vessels, such as those in the head, those leading to the head or the main vein to the liver, or for smaller blood vessels such as those in lesions (areas of disease) in the breast or liver;
Danish: SonoVue kan anvendes hos voksne ved Doppler-undersøgelser dels af store kar, f.eks. karrene i hovedet, de kar, der fører blod til hovedet og leverens hovedvene, og dels af mindre kar, f.eks. ved læsioner (sygdomsområder) i brystet eller leveren
English: How is SonoVue used?
Danish: Hvordan anvendes SonoVue?
English: For practical information about using SonoVue, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af SonoVue, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: These involved a total of 317 patients, and compared SonoVue with another contrast agent and placebo (a dummy treatment).
Danish: Her blev SonoVue sammenlignet med et andet kontraststof og med placebo (en virkningsløs behandling).
English: What benefits of SonoVue have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved SonoVue?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of SonoVue have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af SonoVue.
English: For the smaller vessels, SonoVue led to better quality scans when looking at the blood flow in breast and liver lesions.
Danish: Ved undersøgelse af de mindre kar forbedrede SonoVue scanningskvaliteten med henblik på vurdering af blodgennemstrømningen i læsioner i brystet og leveren.
English: For the full list of all side effects reported with SonoVue, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved SonoVue fremgår af indlægssedlen.
English: Using SonoVue to measure blood flow in large blood vessels improved the quality of the scan when testing the cerebral arteries (in the head), the carotids (in the neck) and the portal vein (leading to the liver), but not the renal arteries (leading to the kidneys).
Danish: Anvendelse af SonoVue til at måle blodgennemstrømningen i store kar forbedrede scanningskvaliteten ved undersøgelse af hjernearterierne, halspulsårerne og portåren (venen til leveren), men ikke af nyrepulsårerne.
English: This helps to enhance the results of tests that rely on measuring ultrasound.
Danish: Det giver bedre resultater ved ultralydsundersøgelser.
English: When used to detect vesicoureteral reflux in children, 1 ml of SonoVue is given by a catheter into the bladder, which is then filled with saline (salt) solution until the patient feels the need to empty their bladder.
Danish: Blæren fyldes herefter med saltopløsning, indtil patienten føler trang til at tømme blæren.
English: When made up into a solution, SonoVue contains sulphur hexafluoride gas as ‘microbubbles' in suspension in a liquid.
Danish: Når SonoVue blandes til en opløsning, vil det indeholde sulphurhexafluoridgas som opslæmmede "mikrobobler".
English: How does SonoVue work?
Danish: Hvordan virker SonoVue?
English: They may also be given a repeat dose after one hour.
Danish: De kan også gives endnu en dosis efter en time.
English: It must not be used in patients with the following conditions:
Danish: Det må ikke anvendes til patienter med følgende lidelser:
English: This means that it is similar to a reference medicine, containing the same active substance but in a different concentration.
Danish: Det betyder, at det svarer til et referencelægemiddel, som indeholder det samme aktive stof, men i en anden koncentration.
English: It can only be obtained with a prescription and must be given by a healthcare professional.
Danish: Det udleveres kun efter recept og skal indgives af sundhedspersonale.
English: • glucose-6-phosphate dehydrogenase deficiency (G6PD),
Danish: • glukose-6-phosphat-dehydrogenasemangel (G6PD-mangel)
English: A repeat dose may be given one hour after the first dose if symptoms persist or come back, or if the level of methaemoglobin in the blood stays higher than normal.
Danish: En ny dosis kan indgives en time efter den første dosis i tilfælde af vedvarende eller tilbagevendende symptomer, eller hvis methæmoglobinniveauet i blodet forbliver højere end normalt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Methylthioninium chloride Proveblue on 6 May 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Methylthioniniumchlorid Proveblue den 6. maj 2011.
English: The usual dose for adults and children aged above three months is 1 to 2 mg per kilogram (kg) body weight.
Danish: Den sædvanlige startdosis for voksne og børn over tre måneder er 1-2 mg pr. kilogram (kg) legemsvægt.
English: The full EPAR for Methylthioninium chloride Proveblue can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Methylthioniniumchlorid Proveblue findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The dose in children aged three months or less is 0.3 to 0.5 mg/kg.
Danish: Dosis til børn på tre måneder eller derunder er 0,3-0,5 mg/kg.
English: Substances that may cause methaemoglobinaemia include some antibiotics, local anaesthetics, nitrates in drinking water and pesticides.
Danish: Blandt de stoffer, der kan forårsage methæmoglobinæmi, er nogle former for antibiotika, lokalbedøvelse, nitrater i drikkevandet og pesticider.
English: • deficiency in the enzyme NADPH reductase.
Danish: • mangel på enzymet NADPH-reduktase.
English: The electrons are then transferred to the iron atoms in the abnormal haemoglobin, converting them into the normal ferrous form.
Danish: Elektronerne overføres så til jernatomerne i det unormale hæmoglobin, hvorved de omdannes til den normale ferroform.
English: Because methylthioninium chloride has been used in the European Union for several decades to treat methaemoglobinaemia, the company presented data on its use from the published literature, which confirmed that methylthioninium chloride is effective in treating methaemoglobinaemia that has been caused by exposure to a medicine or chemical in adults and children.
Danish: Fordi Methylthioniniumchlorid Proveblue har været anvendt i Den Europæiske Union gennem flere årtier til behandling af methæmoglobinæmi, forelagde virksomheden data vedrørende brugen fra den offentliggjorte litteratur, som bekræftede, at methylthioniniumchlorid er effektivt til behandling af methæmoglobinæmi forårsaget af eksponering for et lægemiddel eller kemikalie hos voksne og børn.
English: Methylthioninium chloride Proveblue is used in adults and children of all ages as an antidote to treat symptoms of methaemoglobinaemia caused by the use of certain medicines or chemicals.
Danish: Methylthioniniumchlorid Proveblue anvendes til voksne og børn i alle aldre som modgift til behandling af symptomer på methæmoglobinæmi forårsaget af anvendelse af visse lægemidler eller kemikalier.
English: It does this by accepting negatively charged electron particles through an enzyme called ‘NADPH methaemoglobinaemia reductase'.
Danish: Dette sker ved, at negativt ladede elektroner accepteres via et enzym kaldet "NADPHmethæmoglobinreduktase".
English: The Committee concluded the long experience with the active substance, methylthioninium chloride, shows that it is effective in treating methaemoglobinaemia.
Danish: Udvalget konkluderede, at de langvarige erfaringer med det aktive stof, methylthioniniumchlorid, viser, at det er effektivt til behandling af methæmoglobinæmi.
English: This is a summary of the European public assessment report (EPAR) for Methylthioninium chloride Proveblue.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Methylthioniniumchlorid Proveblue.
English: • methaemoglobinaemia caused by nitrite during treatment of cyanide poisoning,
Danish: • methæmoglobinæmi fremkaldt af nitrit under behandling af cyanidforgiftning
English: Methylthioninium chloride Proveblue must not be used in people who are hypersensitive (allergic) to methylthioninium chloride, or to any other thiazine dyes (the group to which methylthioninium chloride belongs).
Danish: Methylthioniniumchlorid Proveblue må ikke anvendes til personer, som er overfølsomme (allergiske) over for methylthioniniumchlorid eller andre thiazinfarvestoffer (den gruppe, som methylthioniniumchlorid tilhører).
English: Exposure to certain medicines or chemicals can cause the iron in the haemoglobin to change to the ‘ferric' form (Fe3+) seen in methaemoglobinaemia which is less able to transport oxygen.
Danish: Eksponering for visse lægemidler eller kemikalier kan få jernet i hæmoglobinet til at ændre sig til "ferri"-formen (Fe3+), der findes i methæmoglobin, som transporterer ilt mindre effektivt.
English: The most common side effects with methylthioninium chloride are dizziness, paraesthesia (unusual sensations like ‘pins and needles'), dysgeusia (taste disturbances), nausea (feeling sick), skin discoloration, chromaturia (abnormal colouration of the urine), sweating and pain at the site of injection or in a limb.
Danish: De hyppigste bivirkninger ved methylthioniniumchlorid er svimmelhed, prikkende og stikkende fornemmelse (paræstesi), smagsforstyrrelser (dysgeusi), kvalme, misfarvning af huden, unormal farve af urinen (kromaturi), svedtendens og smerte på injektionsstedet eller i et af lemmerne.
English: Methylthioninium chloride Proveblue is available as a solution for injection (5 mg/ml), which is injected slowly into a vein over a period of five minutes.
Danish: Methylthioniniumchlorid Proveblue fås som en injektionsvæske, opløsning (5 mg/ml), som indsprøjtes langsomt i en vene over et tidsrum på 5 minutter.