natgillin/translations-raw huggingface dataset:
En glemt dosis bør tages, når patienten kommer i tanker om dette - dog ikke som en dobbeltdosis. 
If a dose is missed, it should be taken as soon as the patient remembers.
Linagliptin viste sig desuden at medføre signifikant reduktion i faste-plasma-glucose (FPG) og 2timers postprandial glucose (PPG). 
Linagliptin also showed significant improvements in fasting plasma glucose (FPG), and 2-hour post-prandial glucose (PPG) compared to placebo.
Lægen vil måske nedsætte dosis af sulfonylurinstof for at undgå, at dit blodsukker bliver for lavt. 
• are taking an anti-diabetic medicine known as a ‘sulphonylurea'(e.g. glimepiride, glipizide), your doctor may want to reduce your dose of sulphonylurea when you take it together with Trajenta in order to avoid your blood sugar going too low.
Linagliptin medførte signifikant reduktion i HbA1c (-0,59 % ændring sammenlignet med placebo efter 12 uger) i forhold til et gennemsnitligt baseline-HbA1c på 8,2 %. 
Linagliptin provided significant improvements in HbA1c (-0.59 % change compared to placebo after 12 weeks), from a mean baseline HbA1c of 8.2%.
Trajenta kan i kombination med sulfonylurinstof og/eller insulin medføre for lavt blodsukker (hypoglykæmi). 
Taking Trajenta in combination with medicines called sulphonylureas and/or insulin can cause too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines or work without safe foothold.
Baseret på en farmakokinetisk populationsanalyse af fase I- og fase II-data, havde alder ikke nogen klinisk relevant indflydelse på linagliptins farmakokinetik. 
No dosage adjustment is required based on age up to 80 years, as age did not have a clinically relevant impact on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
og svær (< 30 ml/min.) 
had eGFR < 30 mL/min/1.73 m 2.
Dosisjustering er ikke nødvendig på baggrund af etnisk oprindelse. 
No dosage adjustment is necessary based on race.
Linagliptin medførte signifikant reduktion i HbA1c, (ændring på -0,64 % sammenlignet med placebo efter 24 uger) i forhold til et gennemsnitligt HbA1c ved baseline på 7,8 %. 
Linagliptin provided significant improvements in HbA1c (-0.64 % change compared to placebo after 24 weeks), from a mean baseline HbA1c of 7.8%.
tillægsplacebo -0,32 % (95 %-CI: -0,52; -0,13)) og -0,58 % (signifikant forskel ift. 
with a mean treatment difference of 0.20% (97.5% CI: 0.09, 0.299).
Det skal du vide, før du begynder at tage Trajenta Sådan skal du tage Trajenta Bivirkninger 
What Trajenta is and what it is used for What you need to know before you take Trajenta How to take Trajenta
• i kombination med andre antidiabetika, herunder insulin, når disse ikke giver tilstrækkelig glykæmisk kontrol (se pkt. 
• in combination with other medicinal products for the treatment of diabetes, including insulin,
• har haft allergiske reaktioner over for anden diabetesmedicin 
• have had allergic reactions to any other medicines that you take to control the amount of sugar in your blood.
Linagliptin medførte signifikant reduktion i HbA1c, (ændring på -0,57 % sammenlignet med placebo) i forhold til et gennemsnitligt baseline-HbA1c på 8,09 %. 
Linagliptin provided significant improvements in HbA1c, (-0.57% change compared to placebo), from a mean baseline HbA1c of 8.09%.
Linagliptin medførte signifikant reduktion i HbA1c, (ændring på -0,62 % vs placebo) i forhold til et gennemsnitligt baseline-HbA1c på 8,14 %. 
Linagliptin provided significant improvements in HbA1c (-0.62% change compared to placebo), from a mean baseline HbA1c of 8.14%.
Bulløs pemfigoid 
Hepatic impairment
Baseret på en farmakokinetisk populationsanalyse af fase I- og fase II-data havde BMI ikke nogen klinisk relevant indvirkning på linagliptins farmakokinetik. 
BMI had no clinically relevant effect on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase
Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion. 
For patients with renal impairment, no dose adjustment for linagliptin is required.
Et 24-ugers dobbeltblindet, placebokontrolleret studie evaluerede virkningen og sikkerheden af linagliptin 5 mg i kombination med insulin og til insulin i tillæg til metformin og/eller pioglitazon. 
The efficacy and safety of the addition of linagliptin 5 mg to insulin alone or in combination with metformin and/or pioglitazone has been evaluated in a double-blind placebo-controlled study of 24 weeks duration.
Linagliptin medførte signifikant reduktion i HbA1c, (ændring på -0,64 % sammenlignet med placebo) i forhold til et gennemsnitligt baseline-HbA1c på 8 %. 
Linagliptin provided significant improvements in HbA1c, (-0.64% change compared to placebo), from a mean baseline HbA1c of 8%.
Linagliptin medførte signifikant reduktion i HbA1c, (ændring på -0,65 % sammenlignet med placebo) i forhold til et gennemsnitligt HbA1c ved baseline på 8,3 %. 
Linagliptin provided significant improvements in HbA1c (-0.65% compared to placebo) from a mean baseline HbA1c of 8.3%.
ikke almindelig 
uncommon
I et 24-ugers dobbeltblindet placebokontrolleret studie blev effekt og sikkerhed af linagliptin i kombination med metformin undersøgt. 
The efficacy and safety of linagliptin in combination with metformin was evaluated in a double-blind placebo-controlled study of 24 weeks duration.
Dette sammendrag blev sidst ajourført i 01-2019. 
This summary was last updated in 01-2019.
Dosen af Ravicti afhænger af patientens kost, højde og vægt. 
The dose of Ravicti depends on the patient's diet, height and weight.
Data fra supplerende studier viste en lignende virkning hos børn, der blev behandlet med Ravicti fra fødslen. 
Data from additional studies showed a similar effect in children treated with Ravicti from birth.
Andre oplysninger om Ravicti 
Other information about Ravicti
For mere information om brug af Ravicti, se indlægssedlen eller kontakt lægen eller apotekspersonalet. 
For more information about using Ravicti, see the package leaflet or contact your doctor or pharmacist.
Yderligere information om lægemidler til sjældne sygdomme kan findes på Det Europæiske lægemiddelagenturs websted ema.europa.eu/en/medicines/ /ema_group_types/ema_orphan. 
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.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ravicti? 
What measures are being taken to ensure the safe and effective use of Ravicti?
Dette resulterer derfor i en bedre kontrol med blodets ammoniakindhold i løbet af hele dagen. 
Therefore, this results in a better control of blood ammonia levels over the whole day.
Under behandlingen skal der regelmæssigt tages blodprøver for at justere dosis. 
Regular blood tests are needed to adjust the dose.
Der afventes dog yderligere data om den langsigtede sikkerhed af Ravicti. 
However, further data on the long-term safety of Ravicti are awaited.
Som for alle lægemidler bliver data vedrørende brug af Ravicti løbende overvåget. 
As for all medicines, data on the use of Ravicti are continuously monitored.
Den samlede dagsdosis af Ravicti skal opdeles i lige store portioner og indtages sammen med hvert måltid. 
The total daily dose of Ravicti should be divided into equal amounts and given with each meal.
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). 
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).
Den virksomhed, der markedsfører Ravicti, skal oprette et patientregister, der skal give flere oplysninger om lægemidlets langsigtede fordele og sikkerhed. 
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.
Hvad er Ravicti, og hvad anvendes det til? 
What is Ravicti and what is it used for?
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 
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
Behandlingen med Ravicti kan være livslang, hvis ikke patienten får en vellykket levertransplantation. 
Ravicti may be a life-long treatment unless the patient has a successful liver transplant.
En oversigt over Ravicti, og hvorfor det er godkendt i EU 
An overview of Ravicti and why it is authorised in the EU
Bivirkninger rapporteret for Ravicti vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Ravicti are carefully evaluated and any necessary action taken to protect patients.
Ravicti anvendes hos patienter, der mangler et eller flere af følgende enzymer: carbamoylphosphatsyntase-I, ornithincarbamoyltransferase, argininosuccinatsynthetase, argininosuccinatlyase, arginase I og ornithintranslocase. 
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.
Det Europæiske Lægemiddelagentur vurderede, at fordelene ved Ravicti opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
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.
Forstyrrelser i urinstofcyklus er sjældne, og Ravicti blev udpeget som "lægemiddel til sjældne sygdomme" for flere former af sygdommen den 10. juni 2010. 
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.
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. 
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.
Hvorfor blev Ravicti godkendt i EU? 
Why is Ravicti authorised in the EU?
Ravicti er et depotpræparat, hvilket betyder, at det aktive stof frigives dagen igennem. 
Ravicti is a sustained-release medicine, meaning the active substance is released throughout the day.
Virkningen blev hovedsagelig målt på ændringen i blodets ammoniakindhold efter 4 ugers behandling. 
The main measure of effectiveness was the change in the blood level of ammonia after 4 weeks of treatment.
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. 
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.
Denne fjernelse af proteiner reducerer indholdet af kvælstof i kroppen og reducerer den mængde ammoniak, der produceres. 
This removal of proteins decreases the levels of nitrogen in the body, reducing the amount of ammonia produced.
Af samme grund må Ravicti ikke anvendes til at behandle akut hyperammonæmi, da der i sådanne tilfælde kræves en mere hurtigvirkende behandling. 
For this same reason Ravicti must not be used to treat acute hyperammonaemia as more rapidly acting treatments are needed in these cases.
Ravicti (glycerolphenylbutyrat) 
Ravicti (glycerol phenylbutyrate)
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. 
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.
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. 
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.
Hvilke risici er der forbundet med Ravicti? 
What are the risks associated with Ravicti?
Patienter med forstyrrelser i urinstofcyklus er ikke i stand til at udskille overflødigt kvælstof fra kroppen, da de mangler visse leverenzymer. 
Patients with urea cycle disorders are not able to get rid of waste nitrogen from the body because they lack some liver enzymes.
Lægemidlet udleveres kun efter recept, og behandlingen skal ordineres af en læge med erfaring i behandling af forstyrrelser i urincyklus. 
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.
Den fuldstændige liste over bivirkninger og begrænsninger med Ravicti fremgår af indlægssedlen. 
For the full list of side effects and restrictions with Ravicti, see the package leaflet.
Phenylacetat bindes til aminosyren glutamin, som findes i proteiner, for at danne et stof, som nyrerne kan fjerne fra kroppen. 
Phenylacetate attaches to the amino acid glutamine found in proteins to form a substance that the kidneys can remove from the body.
Bivirkningerne ved Ravicti omfatter hovedsagelig tarmen og anses for at kunne håndteres. 
The side effects of Ravicti affect mainly the gut and are considered manageable.
Ravicti er et lægemiddel til behandling af forstyrrelser i urinstofcyklus hos voksne og børn, når sygdommen ikke kan håndteres ved kostændringer alene. 
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.
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. 
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.
I kroppen omdannes overflødigt kvælstof til ammoniak, som er skadeligt, når det ophobes. 
In the body, waste nitrogen is turned into ammonia, which is harmful when it accumulates.
Det aktive stof i Ravicti, glycerolphenylbutyrat, omdannes i kroppen til phenylacetat. 
The active substance in Ravicti, glycerol phenylbutyrate, is converted to phenylacetate in the body.
Ravicti må ikke anvendes til behandling af pludselig stigning i blodets ammoniakindhold (akut hyperammonæmi). 
Ravicti must not be used to treat acute hyperammonaemia (sudden rise of blood ammonia levels).
Ravicti indeholder det aktive stof glycerolphenylbutyrat. 
Ravicti contains the active substance glycerol phenylbutyrate.
Hvordan anvendes Ravicti? 
How is Ravicti used?
Ravicti var effektivt til at nedsætte blodets ammoniakindhold ved forstyrrelser i urincyklus. 
Ravicti is effective in reducing the blood level of ammonia in patients with urea cycle disorders.
Hvilke fordele viser studierne, at der er ved Ravicti? 
What benefits of Ravicti have been shown in studies?
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 Ravicti. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ravicti have also been included in the summary of product characteristics and the package leaflet.
Hvordan virker Ravicti? 
How does Ravicti work?
Behandlingen skal standse, hvis leverfunktionen ikke bedres i løbet af tre måneder. 
Treatment should be stopped if liver function does not improve within three months.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Orphacol den 12. september 2013. 
The European Commission granted a marketing authorisation valid throughout the European Union for Orphacol on 12 September 2013.
Orphacol er godkendt under “særlige omstændigheder”. 
Orphacol has been authorised under ‘exceptional circumstances'.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Orphacol. 
This is a summary of the European public assessment report (EPAR) for Orphacol.
Det må ikke tages af patienter, der i forvejen får phenobarbital, et lægemiddel til behandling af epilepsi. 
It must not be taken by patients already taking phenobarbital, a medicine used to treat epilepsy.
Det anvendes til behandling af voksne og børn over 1 måned, som har en genetisk abnormitet, der gør dem ude af stand til at producere galde. 
It is used to treat adults and children from one month of age who have a genetic abnormality that makes them unable to produce bile.
Andre oplysninger om Orphacol 
Other information about Orphacol
Der er udarbejdet en risikostyringsplan for at sikre, at Orphacol anvendes så risikofrit som muligt. 
A risk management plan has been developed to ensure that Orphacol is used as safely as possible.
Orphacol leveres som kapsler og skal tages hver dag på omtrent samme klokkeslæt sammen med et måltid. 
Orphacol is available as capsules and should be taken every day at approximately the same time, with a meal.
Da antallet af patienter med medfødte fejl i syntesen af primære galdesyrer er lavt, betragtes sygdommen som “sjælden”, og Orphacol blev den 18. december 2002 udpeget som “lægemiddel til sjældne sygdomme”. 
Because the number of patients with inborn errors in primary bile acid synthesis is low, the condition is considered ‘rare', and Orphacol was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 December 2002.
Da cholsyre er et velkendt stof, og da dets anvendelse ved sådanne enzymmangler er anerkendt, forelagde ansøgeren data fra den videnskabelige litteratur. 
Because cholic acid is a well-known substance, and its use in these enzyme deficiencies is well established, the applicant presented data from the scientific literature.
Den fuldstændige EPAR for Orphacol findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
The full EPAR for Orphacol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Orphacol? 
What measures are being taken to ensure the safe and effective use of Orphacol?
Hvad er Orphacol, og hvad anvendes det til? 
What is Orphacol and what is it used for?
Udvalget for lægemidler til mennesker (CHMP) bemærkede, at anvendelse af cholsyre til behandling af medfødte fejl i syntese af primære galdesyrer var velkendt i medicinsk praksis og dokumenteret i den videnskabelige litteratur, skønt antallet af dokumenterede tilfælde var lavt som følge af sygdommens sjældenhed. 
The Committee for Medicinal Products for Human Use (CHMP) noted that the use of cholic acid to treat inborn errors in primary bile acid synthesis was well established in medical practice and documented in the scientific literature, although the number of documented cases was low due to the rarity of the condition.
Når disse primære galdesyrer mangler, producerer kroppen i stedet abnorme galdesyrer, som kan skade leveren og eventuelt medføre livstruende leversvigt. 
When these primary bile acids are lacking, the body produces abnormal bile acids instead which can damage the liver, potentially leading to life-threatening liver failure.
Ansøgeren forelagde data fra den videnskabelige litteratur om 49 patienter med medfødte fejl i syntesen af primære galdesyrer (38 patienter med mangel på 3β-Hydroxy-Δ5-C27-steroid oxidoreduktase og 11 patienter med mangel på Δ4-3-Oxosteroid-5β-reduktase). 
The applicant presented data on 49 patients with inborn errors in primary bile acid synthesis, taken from the scientific literature (38 patients with 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency and 11 patients with Δ4-3-Oxosteroid-5β-reductase deficiency).
Hvorfor er Orphacol blevet godkendt? 
Why is Orphacol approved?
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Orphacol findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
The summary of the opinion of the Committee for Orphan Medicinal Products for Orphacol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Da Orphacol er godkendt under særlige omstændigheder, skal den virksomhed, der markedsfører Orphacol, oprette en database over patienter, der behandles med Orphacol, for at overvåge sikkerheden og virkningen af behandlingen, og skal fremsende resultaterne til CHMP med bestemte regelmæssige mellemrum. 
Since Orphacol has been approved under exceptional circumstances, the company that markets Orphacol will establish a database of patients treated with Orphacol to monitor the safety and effectiveness of the treatment, and will submit the results to the CHMP at regular, specified intervals.
Bivirkningerne med Orphacol var diarré, kløe (pruritus), stigning i transaminasekoncentration (leverenzymer) og eventuelt galdesten, skønt deres hyppighed ikke med sikkerhed kunne vurderes af de foreliggende begrænsede data. 
The side effects seen with Orphacol were diarrhoea, pruritus (itching), increases in transaminases (liver enzymes) and possibly gallstones, although their frequency could not be reliably estimated from the available limited data.
Orphacol cholsyre 
Orphacol cholic acid
Det er ikke en praktisk vejledning i, hvordan Orphacol bør anvendes. 
It is not intended to provide practical advice on how to use Orphacol.
Cholsyre er den vigtigste primære galdesyre, der produceres af leveren. 
Cholic acid is the main primary bile acid produced by the liver.
Hvilke oplysninger afventes der stadig for Orphacol? 
What information is still awaited for Orphacol?
Det betyder, at det ikke har været muligt at indhente fyldestgørende oplysninger om Orphacol, fordi sygdommen er sjælden. 
This means that because the disease is rare, it has not been possible to obtain complete information about Orphacol.
Orphacol udleveres kun efter recept, og ordination og behandling med Orphacol bør iværksættes og overvåges af en læge, der er specialiseret i leversygdomme. 
The medicine can only be obtained with a prescription and treatment with Orphacol should be started and supervised by a doctor specialised in liver disease.
Orphacol bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for cholsyre eller andre af indholdsstofferne. 
Orphacol should not be used in people who may be hypersensitive (allergic) to cholic acid or any of the other ingredients.
Udvalget besluttede, at fordelene ved Orphacol overstiger risiciene på grundlag af beviser fra den videnskabelige litteratur, og anbefalede udstedelse af markedsføringstilladelse for Orphacol. 
It decided that based on the evidence from the scientific literature Orphacol's benefits are greater than its risks and recommended that it be given marketing authorisation.
Hvilke risici er der forbundet med Orphacol? 
What are the risks associated with Orphacol?