FrancophonIA/ELRC3.0 huggingface dataset:
English: Linagliptin provided significant improvements in HbA1c, (-0.64% change compared to placebo), from a mean baseline HbA1c of 8%.
Danish: Linagliptin medførte signifikant reduktion i HbA1c, (ændring på -0,64 % sammenlignet med placebo) i forhold til et gennemsnitligt baseline-HbA1c på 8 %.
English: Linagliptin provided significant improvements in HbA1c (-0.65% compared to placebo) from a mean baseline HbA1c of 8.3%.
Danish: Linagliptin medførte signifikant reduktion i HbA1c, (ændring på -0,65 % sammenlignet med placebo) i forhold til et gennemsnitligt HbA1c ved baseline på 8,3 %.
English: uncommon
Danish: ikke almindelig
English: The efficacy and safety of linagliptin in combination with metformin was evaluated in a double-blind placebo-controlled study of 24 weeks duration.
Danish: I et 24-ugers dobbeltblindet placebokontrolleret studie blev effekt og sikkerhed af linagliptin i kombination med metformin undersøgt.
English: This summary was last updated in 01-2019.
Danish: Dette sammendrag blev sidst ajourført i 01-2019.
English: The dose of Ravicti depends on the patient's diet, height and weight.
Danish: Dosen af Ravicti afhænger af patientens kost, højde og vægt.
English: Data from additional studies showed a similar effect in children treated with Ravicti from birth.
Danish: Data fra supplerende studier viste en lignende virkning hos børn, der blev behandlet med Ravicti fra fødslen.
English: Other information about Ravicti
Danish: Andre oplysninger om Ravicti
English: For more information about using Ravicti, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Ravicti, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Further information on the orphan designations can be found on the European Medicines Agency's website ema.europa.eu/en/medicines/ /ema_group_types/ema_orphan.
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes på Det Europæiske lægemiddelagenturs websted ema.europa.eu/en/medicines/ /ema_group_types/ema_orphan.
English: What measures are being taken to ensure the safe and effective use of Ravicti?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ravicti?
English: Therefore, this results in a better control of blood ammonia levels over the whole day.
Danish: Dette resulterer derfor i en bedre kontrol med blodets ammoniakindhold i løbet af hele dagen.
English: Regular blood tests are needed to adjust the dose.
Danish: Under behandlingen skal der regelmæssigt tages blodprøver for at justere dosis.
English: However, further data on the long-term safety of Ravicti are awaited.
Danish: Der afventes dog yderligere data om den langsigtede sikkerhed af Ravicti.
English: As for all medicines, data on the use of Ravicti are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Ravicti løbende overvåget.
English: The total daily dose of Ravicti should be divided into equal amounts and given with each meal.
Danish: Den samlede dagsdosis af Ravicti skal opdeles i lige store portioner og indtages sammen med hvert måltid.
English: Since proteins are a source of nitrogen, Ravicti must be used together with a special low-protein diet, and sometimes with dietary supplements (depending on the daily protein intake needed for growth and development).
Danish: Da proteiner er en kvælstofkilde, skal Ravicti anvendes sammen med en speciel proteinfattig diæt og undertiden med kosttilskud (afhængigt af det daglige proteinindtag, der er nødvendigt for vækst og udvikling).
English: The company that markets Ravicti will set up a registry of patients to obtain further information on the long-term benefits and safety of the medicine.
Danish: Den virksomhed, der markedsfører Ravicti, skal oprette et patientregister, der skal give flere oplysninger om lægemidlets langsigtede fordele og sikkerhed.
English: What is Ravicti and what is it used for?
Danish: Hvad er Ravicti, og hvad anvendes det til?
English: Ravicti received a marketing authorisation valid throughout the EU on 27 November 2015 Further information on Ravicti can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ravicti
Danish: Ravicti fik en markedsføringstilladelse med gyldighed i hele EU den 27. november 2015 Yderligere information om Ravicti findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/ravicti
English: Ravicti may be a life-long treatment unless the patient has a successful liver transplant.
Danish: Behandlingen med Ravicti kan være livslang, hvis ikke patienten får en vellykket levertransplantation.
English: An overview of Ravicti and why it is authorised in the EU
Danish: En oversigt over Ravicti, og hvorfor det er godkendt i EU
English: Side effects reported with Ravicti are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Ravicti vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Ravicti is used in patients who lack one or more of the following enzymes: carbamoyl phosphate synthase-I, ornithine carbamoyltransferase, argininosuccinate synthetase, argininosuccinate lyase, arginase I and ornithine translocase.
Danish: Ravicti anvendes hos patienter, der mangler et eller flere af følgende enzymer: carbamoylphosphatsyntase-I, ornithincarbamoyltransferase, argininosuccinatsynthetase, argininosuccinatlyase, arginase I og ornithintranslocase.
English: The European Medicines Agency decided that the benefits of Ravicti are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur vurderede, at fordelene ved Ravicti opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Urea cycle disorders are rare, and Ravicti was designated an ‘orphan medicine' (a medicine used in rare diseases) for several forms of the disease on 10 June 2010.
Danish: Forstyrrelser i urinstofcyklus er sjældne, og Ravicti blev udpeget som "lægemiddel til sjældne sygdomme" for flere former af sygdommen den 10. juni 2010.
English: Ravicti is available as a liquid (1.1 g/ml) to be taken by mouth, or given through a tube that goes from the nose to the stomach or through the belly into the stomach.
Danish: Ravicti fås som en væske (1,1 g/ml), der enten indtages gennem munden eller gennem en sonde, der fra næsen føres ned i mavesækken eller gennem maveskindet til mavesækken.
English: Why is Ravicti authorised in the EU?
Danish: Hvorfor blev Ravicti godkendt i EU?
English: Ravicti is a sustained-release medicine, meaning the active substance is released throughout the day.
Danish: Ravicti er et depotpræparat, hvilket betyder, at det aktive stof frigives dagen igennem.
English: The main measure of effectiveness was the change in the blood level of ammonia after 4 weeks of treatment.
Danish: Virkningen blev hovedsagelig målt på ændringen i blodets ammoniakindhold efter 4 ugers behandling.
English: Additionally, the Agency considered that since Ravicti is available as a liquid this could make the medicine more palatable especially for children, compared with other medicines available as granules to be added to food; the liquid formulation also facilitates giving it through a tube to patients unable to swallow.
Danish: Desuden fandt agenturet, at da Ravicti fås som en væske, kan dette gøre lægemidlet mere velsmagende, specielt for børn, sammenlignet med andre lægemidler, der fås som granulat til tilsætning til maden; den flydende formulering letter også indgivelse via sonde til patienter, der ikke kan synke.
English: This removal of proteins decreases the levels of nitrogen in the body, reducing the amount of ammonia produced.
Danish: Denne fjernelse af proteiner reducerer indholdet af kvælstof i kroppen og reducerer den mængde ammoniak, der produceres.
English: For this same reason Ravicti must not be used to treat acute hyperammonaemia as more rapidly acting treatments are needed in these cases.
Danish: Af samme grund må Ravicti ikke anvendes til at behandle akut hyperammonæmi, da der i sådanne tilfælde kræves en mere hurtigvirkende behandling.
English: Ravicti (glycerol phenylbutyrate)
Danish: Ravicti (glycerolphenylbutyrat)
English: The most common side effects with Ravicti (which may affect more than 1 in 20 people) are diarrhoea, flatulence (passing gas), headache, decreased appetite, vomiting, tiredness, feeling sick and abnormal skin smell.
Danish: De hyppigste bivirkninger ved Ravicti (som kan forekomme hos mere end 1 ud af 20 personer) er diarré, tarmluft (flatulens), hovedpine, nedsat appetit, opkastning, træthed, kvalme og abnorm hudlugt.
English: The study showed that Ravicti was at least as effective as the comparator in controlling the blood level of ammonia: the estimated average ammonia level was about 870 micromoles per litre in patients treated with Ravicti, compared with about 980 micromoles per litre in patients treated with sodium phenylbutyrate.
Danish: Studiet viste, at Ravicti var mindst ligeså effektivt som sammenligningsstoffet til at kontrollere blodets ammoniakindhold: Det beregnede ammoniakindhold var ca. 870 µmol/l hos patienter behandlet med Ravicti, sammenholdt med ca. 980 µmol/l hos patienter behandlet med natriumphenylbutyrat.
English: What are the risks associated with Ravicti?
Danish: Hvilke risici er der forbundet med Ravicti?
English: Patients with urea cycle disorders are not able to get rid of waste nitrogen from the body because they lack some liver enzymes.
Danish: Patienter med forstyrrelser i urinstofcyklus er ikke i stand til at udskille overflødigt kvælstof fra kroppen, da de mangler visse leverenzymer.
English: It can only be obtained with a prescription and should be prescribed by a doctor who has experience in treating patients with urea cycle disorders.
Danish: Lægemidlet udleveres kun efter recept, og behandlingen skal ordineres af en læge med erfaring i behandling af forstyrrelser i urincyklus.
English: For the full list of side effects and restrictions with Ravicti, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Ravicti fremgår af indlægssedlen.
English: Phenylacetate attaches to the amino acid glutamine found in proteins to form a substance that the kidneys can remove from the body.
Danish: Phenylacetat bindes til aminosyren glutamin, som findes i proteiner, for at danne et stof, som nyrerne kan fjerne fra kroppen.
English: The side effects of Ravicti affect mainly the gut and are considered manageable.
Danish: Bivirkningerne ved Ravicti omfatter hovedsagelig tarmen og anses for at kunne håndteres.
English: Ravicti is a medicine used to manage urea cycle disorders in adults and children, when the diseases cannot be managed by changes in diet alone.
Danish: Ravicti er et lægemiddel til behandling af forstyrrelser i urinstofcyklus hos voksne og børn, når sygdommen ikke kan håndteres ved kostændringer alene.
English: Ravicti has been compared with sodium phenylbutyrate (another medicine used to treat urea cycle disorders) in a study involving 88 adults with urea cycle disorders.
Danish: Ravicti er blevet sammenlignet med natriumphenylbutyrat (et andet lægemiddel til behandling af forstyrrelser i urincyklus) i et studie med deltagelse af 88 voksne med forstyrrelser i urincyklus.