FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean time to peak concentration is 1 hour and the mean peak concentration 195 µg/ml.
Danish: Den gennemsnitlige tid til maksimumkoncentration er 1 time, og den gennemsnitlige maksimumkoncentration er 195 µg/ml.
English: The mean time to peak concentration is 3.74 and 3.43 hours, respectively, and the mean peak concentration is 48.5 and 68.5 µg/ml, respectively.
Danish: Den gennemsnitlige tid til maksimumkoncentration er henholdsvis 3,74 og 3,43 timer, og de gennemsnitlige maksimumkoncentrationer er henholdsvis 48,5 og 68,5 µg/ml.
English: Affects 1 to 10 users in 100
Danish: Rammer fra 1 til 10 brugere ud af 100
English: Serum potassium should be monitored during therapy since renal excretion of phenylacetylglutamine may induce a urinary loss of potassium.
Danish: Serum-kalium bør overvåges i behandlingsforløbet, idet den renale udskillelse af phenylacetylglutamin kan fremkalde tab af kalium via urinen.
English: AMMONAPS 940 mg/g granules
Danish: AMMONAPS 940 mg/g granulat
English: AMMONAPS must be taken with a special diet reduced in protein.
Danish: AMMONAPS skal tages sammen med en særlig lavproteindiæt.
English: Microcrystalline cellulose Magnesium stearate Colloidal anhydrous silica
Danish: Mikrokrystallinsk cellulose Magnesiumstearat Kolloid vandfri silica
English: Each AMMONAPS tablet contains 62 mg (2.7 mmol) of sodium, corresponding to 2.5 g (108 mmol) of sodium per 20 g of sodium phenylbutyrate, which is the maximum daily dose.
Danish: Hver AMMONAPS tablet indeholder 62 mg (2,7 mmol) natrium, svarende til 2,5 g (108 mmol) natrium pr. 20 g natriumphenylbutyrat, som er den maksimale daglige dosis.
English: Sodium phenylbutyrate is a pro-drug and is rapidly metabolised to phenylacetate.
Danish: Natriumphenylbutyrat er et prodrug og metaboliseres hurtigt til phenylacetat.
English: The mean time to peak concentration is 3.55 and 3.23 hours, respectively, and the mean peak concentration is 45.3 and 62.8 µg/ml, respectively.
Danish: Den gennemsnitlige tid til maksimumkoncentration er henholdsvis 3,55 og 3,23 timer, og de gennemsnitlige maksimumkoncentrationer er henholdsvis 45,3 og 62,8 µg/ml.
English: Increased weight.
Danish: Vægtøgning.
English: It is especially important to tell your doctor if you are taking medicines containing: - valproic acid (an antiepileptic drug), - haloperidol (used in certain psychotic disorders), - corticosteroids (cortisone-like medicines that are used to provide relief for inflamed areas of the body), - probenecid (for treatment of hyperuricemia associated with gout)
Danish: Det er især vigtigt, at du fortæller det til din læge, hvis du tager medicin, som indeholder: - valproinsyre (et antiepileptisk lægemiddel) - haloperidol (der anvendes til behandling af visse psykotiske lidelser) - kortikosteroider (kortisonlignende lægemidler, som anvendes til at lindre betændelsestilstande i kroppen) - probenecid (til behandling af forhøjet indhold af urinsyre i blodet i forbindelse med gigt (hyperurikæmi))
English: Calcium stearate Colloidal anhydrous silica
Danish: Calciumstearat Kolloid vandfri silica
English: AMMONAPS 940 mg/g granules.
Danish: AMMONAPS 940 mg/g granulat.
English: - The active substance is sodium phenylbutyrate.
Danish: - Aktivt stof: natriumphenylbutyrat.
English: How to take AMMONAPS
Danish: Sådan skal du tage AMMONAPS
English: The total daily dose of AMMONAPS should be divided into equal amounts and given with each meal (e.g. three times per day).
Danish: Den totale daglige dosis bør inddeles i lige store mængder og indgives ved hvert måltid (fx tre gange dagligt).
English: - The other ingredients are microcrystalline cellulose, magnesium stearate and colloidal anhydrous silica.
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose, magnesiumstearat og kolloid vandfri silica.
English: AMMONAPS tablets can get stuck in the oesophagus and cause ulcers.
Danish: AMMONAPS tabletterne kan sidde fast i spiserøret og forårsage sår.
English: Other medicines and AMMONAPS
Danish: Brug af anden medicin sammen med AMMONAPS
English: It is recommended to use AMMONAPS granules instead.
Danish: Det anbefales at anvende AMMONAPS granulat i stedet.
English: Based on studies of phenylacetylglutamine excretion in patients with urea cycle disorders it is possible to estimate that, for each gram of sodium phenylbutyrate administered, between 0.12 and 0.15 g of phenylacetylglutamine nitrogen are produced.
Danish: Baseret på undersøgelser af udskillelsen af phenylacetylglutamin hos patienter med urinstofcyklusdefekter er det muligt at skønne, at der dannes mellem 0,12 og 0,15 g phenylacetylglutaminkvælstof for hvert gram natriumphenylbutyrat, der er indgivet.
English: Uncommon side effects: deficiency in red blood cells due to bone marrow depression, bruising, altered heart rhythm, rectal bleeding, stomach irritation, stomach ulcer, inflammation of the pancreas.
Danish: Ikke almindelige bivirkninger: mangel på røde blodlegemer som følge af knoglemarvsundertrykkelse, blå mærker, ændret hjerterytme, blødning fra endetarmen, maveirritation, mavesår, betændelse i bugspytkirtlen.
English: Each AMMONAPS tablet contains 62 mg of sodium.
Danish: Hver AMMONAPS tablet indeholder 62 mg natrium.
English: The mean time to peak concentration is 1.35 hour and the mean peak concentration 218 µg/ml.
Danish: Den gennemsnitlige tid til maksimumkoncentration er 1,35 timer, og den gennemsnitlige maksimumkoncentration er 218 µg/ml.
English: EU/1/99/120/001 (250 tablets) EU/1/99/120/002 (500 tablets)
Danish: EU/1/99/120/001 (250 tabletter) EU/1/99/120/002 (500 tabletter)
English: EU/1/99/120/003 266 g granules EU/1/99/120/004 532 g granules
Danish: EU/1/99/120/003 266 g granulat EU/1/99/120/004 532 g granulat
English: Lightly shake the bottle before dispensing.
Danish: Flasken skal rystes let før afmåling af dosis.
English: EU/1/99/120/001 250 tablets EU/1/99/120/002 500 tablets
Danish: EU/1/99/120/001 250 tabletter EU/1/99/120/002 500 tabletter
English: EU/1/99/120/003 (266 g granules) EU/1/99/120/004 (532 g granules)
Danish: EU/1/99/120/003 (266 g granulat) EU/1/99/120/004 (532 g granulat)
English: • Use the correct spoon to dispense the following amount of Ammonaps: 1.2 g = small white spoon, 3.3 g = medium sized yellow spoon and 9.7 g = large blue spoon
Danish: • Brug den rigtige ske til at dosere følgende mængde af Ammonaps, 1,2 g = lille hvid ske;
English: AMMONAPS must be combined with a diet reduced in proteins, designed especially for you by the doctor and the dietician.
Danish: AMMONAPS skal kombineres med en lavproteindiæt,som udarbejdes specielt til dig af en læge eller en kostvejleder.
English: AMMONAPS 500 mg tablets sodium phenylbutyrate
Danish: AMMONAPS 500 mg tabletter Natriumphenylbutyrat
English: - The other ingredients are calcium stearate and colloidal anhydrous silica.
Danish: - Øvrige indholdsstoffer: calciumstearat og kolloid vandfri silica.
English: - if you are allergic to sodium phenylbutyrate or any of the other ingredients of this medicine
Danish: - hvis du er gravid - hvis du ammer - hvis du er allergisk over for natriumphenylbutyrat eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: You should take AMMONAPS by mouth in equally divided doses with each meal (for example three times per day).You should take AMMONAPS with a large volume of water.
Danish: Du skal tage AMMONAPS gennem munden i ligeligt inddelte doser og sammen med hvert måltid (for eksempel tre gange om dagen).
English: Affects more than 1 user in 10
Danish: Meget almindelig: Forekommer hos mere end 1 bruger ud af 10
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret AMMONAPS til dig personligt.
English: One small white spoon of AMMONAPS granules contains 149 mg of sodium.
Danish: Én lille hvid ske med AMMONAPS granulat indeholder 149 mg natrium.
English: One large spoon of AMMONAPS granules contains 1200 mg of sodium.
Danish: En stor skefuld AMMONAPS granulat indeholder 1200 mg natrium.
English: One large blue spoon of AMMONAPS granules contains 1200 mg of sodium.
Danish: Én stor blå ske med AMMONAPS granulat indeholder 1200 mg natrium.
English: If you take more AMMONAPS than you should
Danish: Hvis du har taget for meget AMMONAPS
English: One medium sized yellow spoon of AMMONAPS granules contains 408 mg of sodium.
Danish: Én mellemstor gul ske med AMMONAPS granulat indeholder 408 mg natrium.
English: One small spoon of AMMONAPS granules contains 149 mg of sodium.
Danish: En lille skefuld AMMONAPS granulat indeholder 149 mg natrium.
English: One medium sized spoon of AMMONAPS granules contains 408 mg of sodium.
Danish: En mellemstor skefuld AMMONAPS granulat indeholder 408 mg natrium.
English: After a single dose of 5 g of sodium phenylbutyrate, in the form of tablets, measurable plasma levels of phenylacetate and phenylacetylglutamine are detected 30 and 60 minutes respectively after dosing.
Danish: Efter en enkelt dosis på 5 g natriumphenylbutyrat i tabletform påvises målelige plasmakoncentrationer af phenylacetat og phenylacetylglutamin henholdsvis 30 og 60 minutter efter indgift.
English: Common: Abdominal pain, vomiting, nausea, constipation, dysgeusia Uncommon: Pancreatitis, peptic ulcer, rectal haemorrhage, gastritis
Danish: Almindelig: Mavesmerter, opkastning, kvalme, forstoppelse, smagsforstyrrelser Ikke almindelig: Pankreatitis, mavesår, blødning i rectum, gastritis
English: Each gram of granules contains 940 mg of sodium phenylbutyrate.
Danish: Hvert gram af granulatet indeholder 940 mg natriumphenylbutyrat.
English: After a single dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylacetate and phenylacetylglutamine are detected 30 and 60 minutes respectively after dosing.
Danish: Efter en enkelt dosis på 5 g natriumphenylbutyrat i granulatform påvises der målelige plasmakoncentrationer af phenylacetat og phenylacetylglutamin henholdsvis 30 og 60 minutter efter indgift.
English: After a single oral dose of 5 g of sodium phenylbutyrate, in the form of tablets, measurable plasma levels of phenylbutyrate are detected 15 minutes after dosing.
Danish: Efter en enkelt oral dosis på 5 g natriumphenylbutyrat i form af granulat kan der påvises målbare koncentrationer i plasma af phenylbutyrat 15 minutter efter indgift.
English: Each tablet contains 500 mg sodium phenylbutyrate.
Danish: Hver tablet indeholder 500 mg natriumphenylbutyrat.
English: One gram of AMMONAPS granules contains 940 mg of sodium phenylbutyrate.
Danish: Ét gram AMMONAPS granulat indeholder 940 mg natriumphenylbutyrat.
English: Each tablet of AMMONAPS contains 500 mg of sodium phenylbutyrate.
Danish: Hver tablet med AMMONAPS indeholder 500 mg natriumphenylbutyrat.
English: Affects 1 to 10 users in 1,000
Danish: Ikke almindelig: Rammer fra 1 til 10 brugere ud af 1000 Sjælden:
English: 1 g of granules contains 940 mg of sodium phenylbutyrate
Danish: 1 g granulat indeholder 940 mg natriumphenylbutyrat.
English: AMMONAPS contains sodium
Danish: AMMONAPS indeholder natrium, hvor advarsel er påkrævet
English: Do not store above 25oC
Danish: Må ikke opbevares ved temperaturer over 25 oC.
English: How to store AMMONAPS Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger
English: AMMONAPS granules contain 124 mg (5.4 mmol) of sodium per gram of sodium phenylbutyrate, corresponding to 2.5 g (108 mmol) of sodium per 20 g of sodium phenylbutyrate, which is the maximum daily dose.
Danish: AMMONAPS granulat indeholder 124 mg (5,4 mmol) natrium pr. gram natriumphenylbutyrat.
English: What AMMONAPS is and what it is used for What you need to know before you take AMMONAPS How to take AMMONAPS
Danish: Det skal du vide, før du begynder at tage AMMONAPS Sådan skal du tage AMMONAPS Bivirkninger
English: What AMMONAPS looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Affects less than 1 user in 10,000
Danish: Rammer fra 1 til 10 brugere ud af 10.000 Meget sjælden: Rammer færre end 1 bruger ud af 10.000 Ikke kendt:
English: The PAH can be:
Danish: PAH kan være:
English: Treatment of PAH
Danish: Behandling af PAH
English: This medicine overview was last updated in 10-2019.
Danish: Denne oversigt blev sidst ajourført i 10-2019.
English: Tracleer is taken morning and evening.
Danish: Tracleer tages morgen og aften.
English: • primary (with no identified cause or inherited);
Danish: • primær (uden identificeret årsag eller arvelig)
English: Tracleer received a marketing authorisation valid throughout the EU on 15 May 2002.
Danish: Tracleer fik en markedsføringstilladelse med gyldighed i hele EU den 15. maj 2002.
English: Similar results were seen in the second study after 24 weeks.
Danish: I det andet studie sås lignende resultater efter 24 uger.
English: In the larger study patients were able to walk 44 metres further.
Danish: I det største studie kunne patienterne gå 44 meter længere.
English: Further information on Tracleer can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Tracleer findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: There were too few patients with class IV disease to support the use of the medicine in this group.
Danish: Der var for få patienter med klasse IV-sygdom til at understøtte brugen af lægemidlet i denne gruppe.
English: As for all medicines, data on the use of Tracleer are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Tracleer løbende overvåget.
English: It is available as film-coated tablets (62.5 mg; 125 mg) and as dispersible tablets (32 mg).
Danish: Det fås som filmovertrukne tabletter (62,5 mg og 125 mg) og som opløselige tabletter (32 mg).
English: Patients should take the film-coated tablets with water.
Danish: Patienterne bør tage de filmovertrukne tabletter med vand.
English: Other information about Tracleer
Danish: Andre oplysninger om Tracleer
English: The dispersible tablets should be mixed with a little water on a spoon before being taken.
Danish: De opløselige tabletter skal blandes med lidt vand i en ske inden indtagelse.
English: The PAH seemed to remain stable in almost all of the children during the 12 or 24 weeks of treatment.
Danish: PAH-sygdommen så ud til at være stabiliseret hos næsten alle børnene under de 12 eller 24 ugers behandling.
English: By expanding these blood vessels, pressure is reduced and symptoms are improved.
Danish: Ved at udvide disse blodkar reduceres trykket, og symptomerne bedres.
English: What measures are being taken to ensure the safe and effective use of Tracleer?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tracleer?
English: Tracleer contains the active substance bosentan.
Danish: Tracleer indeholder det aktive stof bosentan.
English: An overview of Tracleer and why it is authorised in the EU
Danish: En oversigt over Tracleer, og hvorfor det er godkendt i EU
English: The dispersible tablets are only for use in patients who cannot swallow the film-coated tablets.
Danish: De opløselige tabletter er kun til brug hos patienter, der ikke kan sluge filmovertrukne tabletter.
English: The European Medicines Agency decided that Tracleer's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Tracleer opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: In adults, it should be started at a dose of 62.5 mg twice a day for four weeks and then increased to the usual dose of 125 mg twice a day.
Danish: Voksne bør starte med en dosis på 62,5 mg to gange dagligt i fire uger og derefter øge dosen til den normale dosis på 125 mg to gange dagligt.
English: Side effects reported with Tracleer are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Tracleer vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Improvements were also seen in a study of 19 children aged between 3 and 15 years taking the filmcoated tablets.
Danish: Der sås også forbedringer i et studie hos 19 børn i alderen 3-15 år, som fik de filmovertrukne tabletter.
English: This is based on two studies in a total of 245 adults with class III or IV disease that was either primary or caused by scleroderma.
Danish: Dette er baseret på to studier hos i alt 245 voksne patienter med PAH af klasse III eller IV, som enten var primær eller forårsaget af sklerodermi.
English: Why has Tracleer been approved?
Danish: Hvorfor er Tracleer godkendt?
English: The ‘class' reflects the severity of the disease: ‘class III' PAH involves marked limitation of physical activity.
Danish: "Klassen" afspejler sygdommens sværhedsgrad: "Klasse III"-PAH medfører svær begrænsning af fysisk aktivitet.
English: The active substance in Tracleer, bosentan, blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow.
Danish: Det aktive stof i Tracleer, bosentan, blokerer et naturligt forekommende hormon (såkaldt endothelin-1 (ET-1)), der får blodkarrene til at trække sig sammen.
English: Tracleer is used to treat patients with class III pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity) and reduce symptoms.
Danish: Tracleer anvendes til behandling af patienter med klasse III-pulmonal arteriel hypertension (PAH) for at forbedre den fysiske kapacitet (evnen til at udføre fysisk aktivitet) og reducere symptomerne.
English: The most common side effects with Tracleer (which may affect more than 1 in 10 people) are headache, fluid retention, anaemia (low levels of haemoglobin, the protein in red blood cells that carries oxygen around the body) and abnormal results of blood tests to check the liver.
Danish: De hyppigste bivirkninger ved Tracleer (som kan forekomme hos mere end 1 ud af 10 personer) er hovedpine, væskeophobning, anæmi (lavt indhold af hæmoglobin, proteinet i røde blodlegemer, som transporterer ilt rundt i kroppen) og unormale resultater af blodprøver til kontrol af leveren.
English: What is Tracleer and what is it used for?
Danish: Hvad er Tracleer, og hvad anvendes det til?
English: Tracleer can only be obtained with a prescription and treatment should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis.
Danish: Tracleer fås kun på recept, og behandlingen bør kun iværksættes og overvåges af en læge med erfaring i behandling af PAH eller systemisk sklerose.
English: 1 year and older, the recommended starting and maintenance dose is 2 mg per kilogram body weight twice a day.
Danish: Hos børn med PAH i alderen et år og derover er den anbefalede start- og vedligeholdelsesdosis 2 mg pr. kg legemsvægt to gange dagligt.
English: For more information about using Tracleer, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Tracleer, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Some improvement with Tracleer can also occur in patients with class II PAH.
Danish: Der kan også ses en vis bedring ved behandling med Tracleer hos patienter med klasse II-PAH.
English: The company that makes Tracleer will provide a patient alert card to remind patients of the need for regular blood tests for liver function and to use effective contraception to avoid pregnancy.
Danish: Virksomheden, der fremstiller Tracleer, vil levere et patientinformationskort, der minder patienterne om regelmæssigt at få taget blodprøver for leverfunktionen og at bruge effektiv prævention for at undgå graviditet.
English: Tracleer must not be used in patients who have certain liver problems, who are pregnant or could become pregnant and who are not using reliable contraceptive methods or who are taking ciclosporin (a medicine that acts on the immune system).
Danish: Tracleer må ikke anvendes hos patienter, der har visse leverproblemer, som er eller kan blive gravide og ikke anvender sikker prævention, eller som tager ciclosporin (et lægemiddel, der virker på immunsystemet).
English: Tracleer was more effective than placebo at reducing the development of new digital ulcers based on two studies in a total of 312 adults.
Danish: Tracleer var mere effektivt end placebo til at reducere udviklingen af nye sår på fingre og tæer i to studier hos i alt 312 patienter.
English: In PAH, severe narrowing of the blood vessels in the lungs increases blood pressure and reduces the amount of blood entering the lungs.
Danish: Ved PAH øger svær forsnævring af blodkarrene i lungerne blodtrykket og reducerer den blodmængde, der kommer ind i lungerne.
English: ‘Class II' involves slight limitation of physical activity.
Danish: Klasse II-PAH medfører let begrænsning af fysisk aktivitet.
English: Similar results were seen in a study in 54 adults with class III PAH that was associated with congenital heart defects.
Danish: Lignende resultater sås i et studie hos 54 voksne patienter med PAH af klasse III, som var forbundet med medfødte hjertefejl.
English: • caused by scleroderma (also called systemic sclerosis, a disease where there is abnormal growth of the connective tissue that supports the skin and other organs);
Danish: • forårsaget af sklerodermi (også kaldet systemisk sklerose, en sygdom med unormal vækst af det bindevæv, der understøtter huden og andre organer)
English: • caused by congenital (inborn) heart defects with shunts (abnormal passageways) causing abnormal flow of blood through the heart and lungs.
Danish: • forårsaget af medfødt hjertefejl med såkaldte shunts (unormale passager), der giver unormal gennemstrømning af blod gennem hjertet og lungerne.
English: In the first study, patients taking Tracleer had an average of 1.4 new digital ulcers after 16 weeks, compared with 2.7 in the patients taking placebo.
Danish: I det første studie havde patienter, der fik Tracleer, gennemsnitligt 1,4 nye sår på fingre og tæer efter 16 uger sammenholdt med 2,7 hos de patienter, der fik placebo.
English: In PAH, Tracleer film-coated tablets added to patient's current therapy was more effective than placebo (a dummy treatment) in improving the distance patients could walk in 6 minutes (a way of measuring exercise capacity) after 16 weeks of treatment.
Danish: Hos patienter med PAH var Tracleer filmovertrukne tabletter i tillæg til patientens aktuelle behandling mere effektivt end placebo (en uvirksom behandling) til at forbedre den distance, som patienterne kan gå på seks minutter (en måde at måle den fysiske kapacitet på) efter behandling i 16 uger.
English: Two additional studies looked at the effects of Tracleer dispersible tablets in children: the first study included 36 children with PAH aged between 2 and 11 years, while the second study included 64 children with PAH aged from 3 months up to 11 years.
Danish: Det første studie omfattede 36 børn med PAH i alderen 2-11 år, mens det andet studie omfattede 64 børn med PAH i alderen 3 måneder-11 år.
English: What are the risks associated with Tracleer?
Danish: Hvilke risici er der forbundet med Tracleer?
English: The second study which also looked at the effect of Tracleer on digital ulcer healing in 190 patients did not find any effect.
Danish: I det andet studie undersøgte man også virkningen af Tracleer på helingen af sår på fingre og tæer hos 190 patienter, dog uden at finde nogen effekt.
English: Tracleer therefore prevents blood vessels from narrowing.
Danish: På den måde forhindrer Tracleer blodkarrene i at trække sig sammen.
English: Tracleer can also be used in adults with systemic sclerosis in whom poor blood circulation caused by the disease has led to the development of digital ulcers (sores on the fingers and toes).
Danish: Tracleer kan også anvendes til voksne med systemisk sklerose, hvor sygdommen har medført dårlig blodcirkulation og dermed dannelse af sår på fingre og tæer.