FrancophonIA/ELRC3.0 huggingface dataset:
English: In the body, waste nitrogen is turned into ammonia, which is harmful when it accumulates.
Danish: I kroppen omdannes overflødigt kvælstof til ammoniak, som er skadeligt, når det ophobes.
English: The active substance in Ravicti, glycerol phenylbutyrate, is converted to phenylacetate in the body.
Danish: Det aktive stof i Ravicti, glycerolphenylbutyrat, omdannes i kroppen til phenylacetat.
English: Ravicti must not be used to treat acute hyperammonaemia (sudden rise of blood ammonia levels).
Danish: Ravicti må ikke anvendes til behandling af pludselig stigning i blodets ammoniakindhold (akut hyperammonæmi).
English: Ravicti contains the active substance glycerol phenylbutyrate.
Danish: Ravicti indeholder det aktive stof glycerolphenylbutyrat.
English: How is Ravicti used?
Danish: Hvordan anvendes Ravicti?
English: Ravicti is effective in reducing the blood level of ammonia in patients with urea cycle disorders.
Danish: Ravicti var effektivt til at nedsætte blodets ammoniakindhold ved forstyrrelser i urincyklus.
English: What benefits of Ravicti have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Ravicti?
English: 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.
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 Ravicti.
English: How does Ravicti work?
Danish: Hvordan virker Ravicti?
English: Treatment should be stopped if liver function does not improve within three months.
Danish: Behandlingen skal standse, hvis leverfunktionen ikke bedres i løbet af tre måneder.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Orphacol on 12 September 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Orphacol den 12. september 2013.
English: Orphacol has been authorised under ‘exceptional circumstances'.
Danish: Orphacol er godkendt under “særlige omstændigheder”.
English: This is a summary of the European public assessment report (EPAR) for Orphacol.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Orphacol.
English: It must not be taken by patients already taking phenobarbital, a medicine used to treat epilepsy.
Danish: Det må ikke tages af patienter, der i forvejen får phenobarbital, et lægemiddel til behandling af epilepsi.
English: 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.
Danish: 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.
English: Other information about Orphacol
Danish: Andre oplysninger om Orphacol
English: A risk management plan has been developed to ensure that Orphacol is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Orphacol anvendes så risikofrit som muligt.
English: Orphacol is available as capsules and should be taken every day at approximately the same time, with a meal.
Danish: Orphacol leveres som kapsler og skal tages hver dag på omtrent samme klokkeslæt sammen med et måltid.
English: 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.
Danish: 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”.
English: 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.
Danish: Da cholsyre er et velkendt stof, og da dets anvendelse ved sådanne enzymmangler er anerkendt, forelagde ansøgeren data fra den videnskabelige litteratur.
English: The full EPAR for Orphacol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Orphacol findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of Orphacol?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Orphacol?
English: What is Orphacol and what is it used for?
Danish: Hvad er Orphacol, og hvad anvendes det til?
English: 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.
Danish: 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.
English: 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.
Danish: Når disse primære galdesyrer mangler, producerer kroppen i stedet abnorme galdesyrer, som kan skade leveren og eventuelt medføre livstruende leversvigt.
English: 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).
Danish: 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).
English: Why is Orphacol approved?
Danish: Hvorfor er Orphacol blevet godkendt?
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Orphacol cholic acid
Danish: Orphacol cholsyre
English: It is not intended to provide practical advice on how to use Orphacol.
Danish: Det er ikke en praktisk vejledning i, hvordan Orphacol bør anvendes.
English: Cholic acid is the main primary bile acid produced by the liver.
Danish: Cholsyre er den vigtigste primære galdesyre, der produceres af leveren.
English: What information is still awaited for Orphacol?
Danish: Hvilke oplysninger afventes der stadig for Orphacol?
English: This means that because the disease is rare, it has not been possible to obtain complete information about Orphacol.
Danish: Det betyder, at det ikke har været muligt at indhente fyldestgørende oplysninger om Orphacol, fordi sygdommen er sjælden.
English: 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.
Danish: Orphacol udleveres kun efter recept, og ordination og behandling med Orphacol bør iværksættes og overvåges af en læge, der er specialiseret i leversygdomme.
English: Orphacol should not be used in people who may be hypersensitive (allergic) to cholic acid or any of the other ingredients.
Danish: Orphacol bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for cholsyre eller andre af indholdsstofferne.
English: 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.
Danish: Udvalget besluttede, at fordelene ved Orphacol overstiger risiciene på grundlag af beviser fra den videnskabelige litteratur, og anbefalede udstedelse af markedsføringstilladelse for Orphacol.
English: What are the risks associated with Orphacol?
Danish: Hvilke risici er der forbundet med Orphacol?
English: The cholic acid contained in Orphacol replaces the patient's missing cholic acid.
Danish: Cholsyre i Orphacol erstatter patientens manglende cholsyre.
English: For more information about treatment with Orphacol, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Orphacol, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In the scientific literature, cholic acid treatment was shown to reduce the amount of abnormal bile acids in patients, to restore the normal functions of the liver and to help delay or prevent the need for a liver transplant.
Danish: I den videnskabelige litteratur blev det påvist, at behandling med cholsyre mindsker mængden af abnorme galdesyrer hos patienterne, genopretter leverens normale funktioner og medvirker til, at levertransplantation kan udsættes eller undgås.
English: Orphacol is used in patients who do not have enough of two specific liver enzymes (3β-Hydroxy-Δ5-C27-steroid oxidoreductase or Δ4-3-Oxosteroid-5β-reductase).
Danish: Orphacol anvendes hos patienter, der ikke har tilstrækkeligt af leverenzymerne 3β-Hydroxy-Δ5-C27-steroid oxidoreduktase eller Δ4-3-Oxosteroid-5β-reduktase.
English: Orphacol is a medicine containing cholic acid, a substance found in the bile which is used to digest fats.
Danish: Orphacol er et lægemiddel, der indeholder cholsyre, som et stof, der findes i galden, hvor det medvirker ved fordøjelsen af fedtstoffer.
English: This makes their liver unable to produce enough of the main components of bile, called primary bile acids, such as cholic acid.
Danish: Deres lever er derfor ude af stand til at producere tilstrækkeligt af galdens hovedbestanddele, de såkaldte primære galdesyrer såsom cholsyre.
English: This helps to decrease the production of abnormal bile acids and contributes to the normal activity of bile in the digestive system, thereby relieving the symptoms of the condition.
Danish: Dette nedsætter produktionen af abnorme galdesyrer og fremmer normal funktion af galde i fordøjelsessystemet, hvorved sygdomssymptomerne lettes.
English: The daily dose is between 5 and 15 mg per kg body weight, adjusted for each patient according to the state of their bile acid, with a minimum daily dose of 50 mg and a maximum of
Danish: Den daglige dosis er mellem 5 og 15 mg/kg kropsvægt og tilpasses hver enkelt patient afhængigt af dennes galdesyre med en minimum- og maksimumdosis på henholdsvis 50 mg og 500 mg. Til små børn, der ikke kan synke kapsler, kan indholdet blandes i modermælkserstatning eller juice.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Orphacol, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og på indlægssedlen for Orphacol er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: It compared the outcomes of 28 patients who received cholic acid with others who were given different bile acids or did not receive bile acid treatment.
Danish: I dette materiale blev 28 patienter, der fik cholsyre, sammenlignet med andre patienter, der fik andre galdesyrer eller ikke blev behandlet med galdesyrer.
English: For practical information about using Orphacol, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Orphacol, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How does Orphacol work?
Danish: Hvordan virker Orphacol?
English: How is Orphacol used?
Danish: Hvordan anvendes Orphacol?
English: What benefits of Orphacol have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Orphacol?
English: The company that makes Orphacol will also provide doctors in all Member States who will use Orphacol with a pack containing product literature and information regarding the correct diagnosis of these disease conditions, the risks of side effects and how to use the medicine properly.
Danish: Pakken skal indeholde produktlitteratur og oplysninger om korrekt diagnose af disse sygdomstilstande, bivirkningsrisici og korrekt anvendelse af lægemidlet.
English: Frequency not known, but may also occur:
Danish: Hyppighed ikke kendt, men kan også opstå:
English: The effects last for at least 12 hours.
Danish: Virkningen holder sig i mindst 12 timer.
English: Just take your next dose at the usual time.
Danish: Tag blot den næste dosis til normal tid.
English: The secondary endpoints in the table above reached statistical significance in the whole population.)
Danish: Det sekundære endepunkt i tabellen ovenfor opnåede statistisk signifikans i hele populationen).
English: Reported over 3 years in a COPD study
Danish: Rapporteret over 3 år i et KOL-studie
English: Note that it is important that you breathe in forcefully.
Danish: Bemærk, at det er vigtigt, at du trækker vejret kraftigt ind.
English: Your inhaler is now ready
Danish: Din inhalator er nu klar til
English: Do not take more than the recommended dose.
Danish: Du må ikke tage mere end den anbefalede dosis.
English: It is not known if this was due to pharmacogenetic or other factors.
Danish: Det er ukendt, om det skyldtes farmakogenetiske forskelle eller andre faktorer.
English: Both non-selective and selective β blockers should be avoided unless there are compelling reasons for their use.
Danish: Både ikke-selektive og selektive β-blokkere bør undgås, medmindre der er vigtige grunde til, at de anvendes.
English: However, these animal experimental results do not seem to be relevant for man given recommended doses.
Danish: Disse eksperimentelle resultater fra dyr synes dog ikke at være relevante for mennesker, der får de anbefalede doser.
English: (*=could not be calculated because of no events in placebo group.
Danish: (*: kunne ikke beregnes, da der ikke var nogen hændelser i placebogruppen.
English: A 4-unit decrease is considered clinically relevant.
Danish: En reduktion på 4 enheder anses for at være klinisk relevant.
English: This could make your breathing worse.
Danish: Det kan forværre din vejrtrækning.
English: Breathe in through your mouth as deeply and as forcefully as you can.
Danish: Træk vejret gennem munden, så dybt og kraftigt som du kan.
English: This study was not designed to investigate the effect on exacerbations.
Danish: Dette studie havde ikke til hensigt at undersøge virkningen på eksacerbationer.
English: Treatment was stepped up every 12 weeks until **total control was achieved or the highest dose of study drug was reached.
Danish: Behandlingen blev optrappet hver 12. uge, indtil der blev opnået **total kontrol, eller indtil den højeste dosis studielægemiddel blev givet.
English: Survival status at 3 years was determined for all patients regardless of withdrawal from study medication.
Danish: Overlevelsesstatus efter 3 år blev bestemt for alle patienter uanset seponering af studielægemidlet.
English: You may notice a taste when you take your inhalation.
Danish: Du bemærker muligvis en smag, når du tager inhalationen.
English: For pharmacokinetic purposes each component can be considered separately.
Danish: For så vidt angår farmakokinetik kan hvert indholdsstof betragtes separat.
English: Take care not to block the air vents.
Danish: Sørg for, at du ikke blokerer luftventilerne.
English: There are no data in humans.
Danish: Der foreligger ingen data for mennesker.
English: Risk in bold figures is statistically significant at the 95% level.
Danish: Risiko med fed skrift er statistisk signifikant på 95 %-niveauet.
English: • Diuretics, also known as ‘water tablets' used to treat high blood pressure.
Danish: • Diuretika, også kaldet "vanddrivende tabletter", der anvendes til at behandle for højt blodtryk.
English: (For Poland only) Teva Operations Poland Sp. z o.o.
Danish: (Kun for Polen) Teva Operations Poland Sp. z o.o.
English: Baseline ICS use at study entry was recorded, but not required in the study.
Danish: Brug af ICS ved indtræden i studiet (baseline) blev registreret, men var ikke et krav i studiet.
English: This training is important to ensure you receive the dose you require.
Danish: Denne træning er vigtig for at sikre, at du får den nødvendige dosis.
English: Caution is recommended and long-term treatment with such drugs should if possible be avoided.
Danish: Forsigtighed anbefales, og langtidsbehandling med sådanne lægemidler bør så vidt muligt
English: These side effects may include any of the following:
Danish: Disse bivirkninger kan omfatte følgende:
English: Depression, aggression (predominantly in children)
Danish: Depression, aggression (især hos børn)
English: Less than 5% of the dose is excreted in urine, mainly as metabolites.
Danish: Under 5 % af dosis udskilles i urinen, primært som metabolitter.
English: Lactose is a type of sugar found in milk.
Danish: Lactose er en sukkerart, der findes i mælk.
English: These effects are much less likely to occur than with oral corticosteroids.
Danish: Disse virkninger er langt mindre sandsynlige end ved orale kortikosteroider.
English: Frequencies were derived from clinical trial data.
Danish: Hyppighederne blev afledt fra data fra kliniske studier.
English: Remove your inhaler from your mouth.
Danish: Fjern inhalatoren fra din mund.
English: To prevent these symptoms, your doctor may prescribe extra corticosteroids in tablet form (such as prednisolone).
Danish: For at undgå disse symptomer kan lægen ordinere ekstra kortikosteroid i tabletform (såsom prednisolon).
English: Not all pack sizes may be marketed in your country.
Danish: Begge pakningsstørrelser er ikke nødvendigvis markedsført i dit land.
English: Allergic reactions to Aerivio Spiromax are uncommon (they may affect up to 1 in 100 people).
Danish: Allergiske reaktioner på grund af Aerivio Spiromax er ikke almindelige (de kan forekomme hos op til 1 ud af 100 personer).
English: Lactose contains small amounts of milk protein which may cause allergic reactions.
Danish: Lactose indeholder små mængder mælkeprotein, som kan forårsage allergiske reaktioner.
English: Consideration should be given to referring the child or adolescent to a paediatric respiratory specialist.
Danish: Det bør overvejes at henvise barnet eller den unge til en pædiatrisk lungespecialist.
English: • Aerivio Spiromax may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods of time.
Danish: • Aerivio Spiromax kan påvirke den normale produktion af steroidhormoner i kroppen, især hvis du har taget høje doser i lang tid.
English: In general inhaled corticosteroids remain the first line treatment for most patients.
Danish: Generelt er inhalationssteroid stadig førstevalgsbehandling for de fleste patienter.
English: Health Related Quality of Life, as measured by the St George's Respiratory Questionnaire (SGRQ) was improved by all active treatments in comparison with placebo.
Danish: Sundhedsrelateret livskvalitet, bedømt ved St George's Respiratory Questionnaire (SGRQ), blev forbedret ved alle aktive behandlinger sammenlignet med placebo.
English: • The mouthpiece will still ‘click' even when your inhaler is empty.
Danish: • Mundstykket vil stadig 'klikke', selv om din inhalator er tom.
English: • Check the dose indicator to see that there are 60 inhalations in the inhaler.
Danish: • Kontroller dosisindikatoren for at se, at der er 60 inhalationer i inhalatoren.
English: However, it should be noted that children and adolescents less than 16 years taking high doses of fluticasone propionate (typically ≥ 1000 micrograms/day) may be at particular risk.
Danish: Det bør imidlertid bemærkes, at børn og unge under 16 år, der tager høje doser fluticasonpropionat (typisk ≥ 1.000 mikrogram/dag), kan have en særlig risiko.
English: It is important to inhale forcefully to ensure optimal dosing.
Danish: Det er vigtigt at inhalere kraftigt for at sikre optimal dosering.
English: Co-administration with erythromycin was not associated with any serious adverse effects.
Danish: Samtidig administration af erythromycin var ikke forbundet med alvorlige bivirkninger.
English: You may notice your heart beating faster than usual and that you feel shaky.
Danish: Du kan bemærke, at dit hjerte banker hurtigere end normalt, eller at du ryster.
English: There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all
Danish: Der er visse tegn på en øget risiko for pneumoni med stigende steroiddoser, men det er ikke endegyldigt blevet vist i alle studier.
English: Cases of Cushing's syndrome and adrenal suppression have been reported.
Danish: Der er blevet rapporteret tilfælde af Cushings syndrom og adrenal suppression.
English: • For inhalations remaining from 20 downwards to ‘8', ‘6', ‘4', ‘2' the numbers are displayed in red on a white background.
Danish: • Fra 20 og nedefter til '8', '6', '4', '2' vises de resterende inhalationer med røde tal på en hvid baggrund.
English: After 12 weeks no children in either treatment arm had abnormally low 24-hour urinary cortisol excretion.
Danish: Efter 12 uger var der ingen børn i nogen af de to behandlingsgrupper, der havde abnormt lav 24-timers ekskretion af cortisol i urinen.
English: Percentage of Patients Attaining *Well Controlled (WC) and **Totally Controlled (TC) Asthma over
Danish: Procentvis andel af patienter, som i løbet af 12 måneder opnåede *Velkontrolleret (WC) og **Totalt kontrolleret (TC) astma
English: This does not need emergency action as adrenal function is recovered in a few days, as verified by plasma cortisol measurements.
Danish: Dette nødvendiggør ikke en krisehandling, da den adrenale funktion generhverves i løbet af få dage, hvilket kan verificeres ved måling af plasma-cortisol.
English: Place the mouthpiece between your teeth.
Danish: Placer mundstykket mellem tænderne.
English: • Headache - this usually gets better as treatment continues.
Danish: • Hovedpine - dette bliver normalt mindre udtalt ved fortsat behandling.
English: The incidence in placebo was not taken into account.
Danish: Der er ikke taget hensyn til hyppigheden i placebogruppen.
English: Packs of 1 and 3 inhalers.
Danish: Pakninger med 1 eller 3 inhalatorer.
English: Medium dose ICS (>500 to 1000 micrograms
Danish: Middeldosis ICS (>500 til 1.000 mikrogram