FrancophonIA/ELRC3.0 huggingface dataset:
English: The main measures of effectiveness were how well the medicines maintained the required sedation level and the time patients needed to spend on a mechanical ventilator (a machine that ‘breathes' for the patient).
Danish: De primære mål for virkning var, hvor godt medicinen opretholdt det ønskede sederingsniveau, og hvor længe patienten havde brug for respirator (en maskine, der "trækker vejret" for patienten).
English: Dexdor is given by infusion (drip) into a vein using a controlled infusion device.
Danish: Dexdor indgives ved infusion (drop) i en blodåre under anvendelse af et apparat til kontrolleret infusion.
English: Dexdor contains the active substance dexmedetomidine.
Danish: Dexdor indeholder det aktive stof dexmedetomidin.
English: What are the risks associated with Dexdor?
Danish: Hvilke risici er der forbundet med Dexdor?
English: Dexdor must not be used in patients with advanced heart block (a type of heart rhythm disorder), patients with uncontrolled low blood pressure and in patients with conditions such as stroke that affect the blood supply to the brain.
Danish: Dexdor må ikke anvendes hos patienter med udtalt hjerteblok (en type hjerterytmeforstyrrelse), patienter med ukontrolleret lavt blodtryk og patienter med tilstande, hvor blodforsyningen til hjernen er påvirket (f.eks. slagtilfælde).
English: The second study involved patients undergoing a fibreoptic intubation (inserting a breathing tube through the nose or the mouth into the windpipe) while patients are awake.
Danish: Det andet studie omfattede patienter, der gennemgik fiberoptisk intubation (indførelse af en vejrtrækningsslange i luftrøret gennem næsen eller munden), mens de var vågne.
English: Dexdor is an additional alternative medicine for achieving lighter levels of sedation in suitable patients.
Danish: Dexdor er et yderligere alternativt lægemiddel, der giver mulighed for at opnå et lettere sederingsniveau hos egnede patienter.
English: A higher proportion of patients treated with Dexdor did not require additional treatment with midazolam (another sedative medicine) to maintain the desired sedation level.
Danish: En større andel af de patienter, der fik Dexdor, krævede ikke yderligere behandling med midazolam (et andet sederende lægemiddel) for at opretholde det ønskede sederingsniveau.
English: The most common side effects with Dexdor (which may affect more than 1 in 10 people) when it is used in intensive care are low or high blood pressure and bradycardia (slow heart rate).
Danish: De hyppigste bivirkninger ved Dexdor (der kan forekomme hos mere end 1 ud af 10 patienter) ved anvendelse på intensivafdelinger er lavt eller højt blodtryk og bradykardi (langsom hjerterytme).
English: When Dexdor is used for awake sedation in diagnostic or surgical procedures, the starting dose depends on the type of procedure and the dose is adjusted to achieve the desired effect.
Danish: Når Dexdor anvendes til vågen sedering ved diagnostiske eller kirurgiske procedurer, afhænger startdosen af, hvilken proceduretype der er tale om, og dosis justeres i forhold til den ønskede effekt.
English: The first study involved patients undergoing surgery or a procedure under an anaesthetic block (where sensation to a part of the body is blocked).
Danish: Det første studie omfattede patienter, der gennemgik en operation eller et indgreb under lokalbedøvelse (hvor følesansen i en del af kroppen blokeres).
English: Dexdor was compared with other sedative medicines (propofol or midazolam) in two main studies involving 1,000 patients who required sedation in intensive care units.
Danish: Dexdor blev sammenlignet med andre sederende lægemidler (propofol eller midazolam) i to hovedstudier med 1.000 patienter, der skulle sederes på intensivafdelinger.
English: Dexdor was compared with placebo (a dummy treatment) in two main studies involving 431 patients.
Danish: Dexdor blev sammenlignet med placebo (ikke-aktivt stof) i to hovedstudier med 431 patienter.
English: For the full list of side effects and restrictions with Dexdor, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Dexdor fremgår af indlægssedlen.
English: Dexdor is a medicine used to sedate (calm or make sleepy) adult patients in the following settings:
Danish: Dexdor er et lægemiddel, der anvendes til at sedere (berolige) voksne patienter i følgende situationer:
English: The studies in intensive care showed that Dexdor compared well with other sedatives.
Danish: Studierne med patienter på intensivafdelinger viste, at Dexdor klarede sig godt i sammenligning med andre sederende lægemidler.
English: Dexdor can only be obtained with a prescription and should be given by a healthcare professional skilled in managing patients in intensive care or giving anaesthetic during diagnostic or surgical procedures.
Danish: Dexdor udleveres kun efter recept og skal gives af en sundhedsperson med erfaring i behandling af patienter på intensivafdelinger og indgivelse af bedøvelsesmidler under diagnostiske og kirurgiske procedurer.
English: When Dexdor is used in intensive care, the dose is adjusted to achieve the desired level of sedation.
Danish: Når Dexdor anvendes på intensivafdelinger, skal dosen justeres i forhold til det ønskede sederingsniveau.
English: The most common side effects when it is used for awake sedation are low blood pressure, respiratory depression (reduced ability to breathe) and bradycardia.
Danish: De hyppigste bivirkninger ved vågen sedering er lavt blodtryk, åndedrætsdepression (nedsat evne til at trække vejret) og bradykardi (langsom hjerterytme).
English: How is Dexdor used?
Danish: Hvordan anvendes Dexdor?
English: What benefits of Dexdor have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Dexdor?
English: How does Dexdor work?
Danish: Hvordan virker Dexdor?
English: In the first study, 65% of patients given Dexdor maintained the required level of sedation compared with 65% of those receiving propofol.
Danish: I det første studie opretholdt 65 % af de patienter, der fik Dexdor, det ønskede sederingsniveau, sammenholdt med 65 % af de patienter, der fik propofol.
English: In the second study, 61% of patients given Dexdor maintained the required level of sedation compared with 57% of those receiving midazolam.
Danish: I det andet studie opretholdt 61 % af de patienter, der fik Dexdor, det ønskede sederingsniveau, sammenholdt med 57 % af de patienter, der fik midazolam.
English: Care should be taken when using Dexdor in patients with reduced liver function and the dose may be reduced.
Danish: Der bør udvises forsigtighed ved anvendelse af Dexdor hos patienter med nedsat leverfunktion.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dexdor have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Dexdor.
English: Midazolam treatment was not required in 53% of patients receiving Dexdor compared with 14% receiving placebo.
Danish: 53 % af de patienter, der fik Dexdor, havde ikke brug for behandling med midazolam, sammenholdt med 14 % af de patienter, der fik placebo.
English: Midazolam treatment was not required in 40% of patients receiving the lower dose of Dexdor and 54% of those receiving the higher dose compared with 3% of patients receiving placebo.
Danish: 40 % af de patienter, der fik den lave dosis Dexdor, og 54 % af de patienter, der fik den høje dosis, havde ikke brug for behandling med midazolam, sammenholdt med 3 % af de patienter, der fik placebo.
English: Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.
Danish: Hvert år gennemgår agenturet alle nye oplysninger, der bliver tilgængelige, og ajourfører om nødvendigt denne oversigt.
English: The recommended dose for each infusion is 4 mg per kilogram of body weight.
Danish: Den anbefalede dosis ved hver infusion er 4 mg pr. kg legemsvægt.
English: Mepsevii has been authorised under ‘exceptional circumstances'.
Danish: Mepsevii er godkendt under "særlige omstændigheder".
English: Before the infusion the patient is given antihistamine treatment to reduce the risk of allergic reactions.
Danish: Inden infusionen får patienten antihistamin for at mindske risikoen for allergiske reaktioner.
English: As for all medicines, data on the use of Mepsevii are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Mepsevii løbende overvåget.
English: Treatment should also be supervised by a healthcare professional with experience in the treatment of MPS VII.
Danish: Behandlingen skal også overvåges af en sundhedsperson med erfaring i behandling af MPS VII.
English: Although only a limited amount of data is available from clinical studies, the European Medicines Agency took into account the life-threatening and debilitating nature of MPS VII and the lack of authorised medicines.
Danish: Selvom der kun foreligger begrænsede data fra kliniske studier, tog Det Europæiske Lægemiddelagentur hensyn til den livstruende og invaliderende karakter af MPS VII samt manglen på godkendte lægemidler.
English: What measures are being taken to ensure the safe and effective use of Mepsevii?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Mepsevii?
English: Other information about Mepsevii
Danish: Andre oplysninger om Mepsevii
English: Side effects reported with Mepsevii are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger indberettet om Mepsevii vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Since Mepsevii has been authorised under exceptional circumstances, the company that markets Mepsevii will conduct a study to provide data on the long-term effectiveness and safety of Mepsevii as well as on the disease itself, including its progression and development of symptoms.
Danish: Da Mepsevii er godkendt under "særlige omstændigheder", skal den virksomhed, der markedsfører Mepsevii, gennemføre et studie for at fremskaffe data om Mepseviis langsigtede effekt og sikkerhed samt data om selve sygdommen, herunder sygdomsprogression og udvikling af symptomer.
English: MPS VII is rare, and Mepsevii was designated an ‘orphan medicine' (a medicine used in rare diseases) on 21 March 2012.
Danish: MPS VII er sjælden, og Mepsevii blev udpeget som "lægemiddel til sjældne sygdomme" den 21. marts 2012.
English: For more information about using Mepsevii, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Mepsevii, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: What is Mepsevii and what is it used for?
Danish: Hvad er Mepsevii, og hvad anvendes det til?
English: An overview of Mepsevii and why it is authorised in the EU
Danish: En oversigt over Mepsevii, og hvorfor det er godkendt i EU
English: Why is Mepsevii authorised in the EU?
Danish: Hvorfor er Mepsevii godkendt i EU?
English: Mepsevii is given every two weeks as an infusion (drip) into a vein lasting 4 hours.
Danish: Mepsevii gives hver 2. uge som en infusion (drop) i en blodåre, der varer 4 timer.
English: Further information on Mepsevii can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Mepsevii findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes her: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
English: Mepsevii contains the active substance vestronidase alfa.
Danish: Mepsevii indeholder det aktive stof vestronidase alfa.
English: The disease leads to build up of GAGs in the body, which causes a wide range of problems, including joint stiffness, short stature, enlarged liver and spleen, hearing loss, cataract and delays in development.
Danish: Sygdommen medfører ophobning af GAG'er i kroppen, og det giver en lang række problemer som f.eks. stive led, lav højdevækst, forstørret lever og milt, høretab, grå stær og forsinket udvikling.
English: In a main study of 12 patients with MPS VII, patients treated with Mepsevii for 6 months had a 65% reduction in their urine levels of GAGs.
Danish: I et hovedstudie af 12 patienter med MPS VII sås en reduktion på 65 % i GAG-niveauet i urinen hos patienter, der blev behandlet med Mepsevii i 6 måneder.
English: The medicine can only be obtained with a prescription and should be given by an appropriately trained healthcare professional who can manage medical emergencies.
Danish: Lægemidlet udleveres kun på recept og skal indgives af en kvalificeret sundhedsperson med erfaring i håndtering af medicinske nødsituationer.
English: In addition, most adverse reactions are mild to moderate in severity.
Danish: Derudover er de fleste bivirkninger lette til moderate.
English: Mepsevii must not be used in patients who have ever had anaphylactic reaction to vestronidase alfa or any of the other ingredients of the medicine.
Danish: Mepsevii må ikke anvendes hos patienter, der tidligere har haft en anafylaktisk reaktion over for vestronidase alfa eller et eller flere af de andre indholdsstoffer i dette lægemiddel.
English: What information is still awaited for Mepsevii?
Danish: Hvilke oplysninger afventes der stadig for Mepsevii?
English: What are the risks associated with Mepsevii?
Danish: Hvilke risici er der forbundet med Mepsevii?
English: This is because it has not been possible to obtain complete information about Mepsevii due to the rarity of the disease and for scientific reasons.
Danish: Det skyldes, at det grundet sygdommens sjældenhed og af videnskabelige årsager ikke har været muligt at indhente fyldestgørende oplysninger om Mepsevii.
English: EMA decided that Mepsevii's benefits are greater than its risks and that it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Mepsevii opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: In 11 out of 12 patients, symptoms, including those affecting vision and movement, improved or did not get worse.
Danish: Hos 11 ud af 12 patienter bedredes eller stabiliseredes symptomerne, herunder syns- og bevægerelaterede symptomer.
English: The most common side effects with Mepsevii (which may affect more than 1 in 10 people) are anaphylactic reaction (sudden, severe allergic reaction), urticaria (itchy rash) and swelling at the infusion site.
Danish: De hyppigste bivirkninger ved Mepsevii (der kan forekomme hos flere end 1 ud af 10 patienter) er anafylaktisk reaktion (pludselig og svær allergisk reaktion), nældefeber (kløende udslæt) og hævelse ved infusionsstedet.
English: Mepsevii is an enzyme replacement therapy that works by replacing the missing enzyme (betaglucuronidase) in patients with MPS VII, helping to break down GAGs and stopping them building up in the body.
Danish: Mepsevii er en enzymerstatningsbehandling, der virker ved at erstatte det manglende enzym (betaglukuronidase) hos patienter med MPS VII og derved fremme nedbrydningen af GAG'er, så disse ikke ophobes i kroppen.
English: Mepsevii reduces the levels of GAGs in the body and improves or at least stabilises the symptoms of MPS VII.
Danish: Mepsevii reducerer GAG-niveauet i kroppen og bedrer eller stabiliserer symptomerne ved MPS VII.
English: Mepsevii has been shown to reduce the levels of GAGs in the body and reduce or stabilise symptoms in patients with MPS VII.
Danish: Det er påvist, at Mepsevii reducerer GAG-niveauet i kroppen og mindsker eller stabiliserer symptomerne hos patienter med MPS VII.
English: How is Mepsevii used?
Danish: Hvordan anvendes Mepsevii?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mepsevii have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Mepsevii.
English: What benefits of Mepsevii have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Mepsevii?
English: How does Mepsevii work?
Danish: Hvordan virker Mepsevii?
English: Mepsevii is a medicine to treat mucopolysaccharidosis type VII (MPS VII, also known as Sly syndrome), an inherited disease caused by a lack of an enzyme needed to break down complex carbohydrates known as glycosaminoglycans (GAGs).
Danish: Det er en arvelig sygdom, der skyldes mangel på et enzym, der er nødvendigt for at nedbryde komplekse kulhydrater (såkaldte glykosaminoglykaner (GAG'er)).
English: Oral use bottle (HDPE)
Danish: Oral anvendelse Flaske (HDPE)
English: 500 mg Film-Coated tablet
Danish: 500 mg Filmovertrukket tablet
English: 120 filmcoated tablets
Danish: filmovertrukne tabletter
English: Invented name Strength Pharmaceutical form
Danish: Styrke Lægemiddelform Administration Emballage Pakningsstørrelse
English: However, try to take your tablet at the same time every day.
Danish: Prøv dog at tage tabletten på samme tidspunkt hver dag.
English: Please note the following:
Danish: Vær opmærksom på følgende:
English: You should consult your doctor as soon as possible.
Danish: Kontakt Deres læge hurtigst muligt.
English: Change in AUC&
Danish: Ændring i AUC&
English: The mechanism of this interaction is not known.
Danish: Mekanismen for denne interaktion er ikke kendt.
English: No specific recommendation.
Danish: Ingen særlig rekommandation.
English: Median follow-up was 4.9 years.
Danish: Middelopfølgningsperioden var 4,9 år.
English: After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Danish: Efter Kommissionens afgørelse vil medlemsstaternes kompetente myndigheder sammen med referencemedlemsstaten opdatere produktoplysningerne efter behov.
English: Avoid drinking too much alcohol while taking this medicine.
Danish: De skal undgå at indtage for meget alkohol, når De tager denne medicin.
English: See sections 4.4 and 4.5 for clinical significance.
Danish: 4.4 og 4.5 for klinisk signifikans.
English: Possible consequences for the efficacy are unknown.
Danish: De mulige konsekvenser for effekten er ukendte.
English: A therapeutic response is evident within 2 weeks, and the maximum therapeutic response is usually achieved within 4 weeks.
Danish: Terapeutisk virkning ses inden for 2 uger, og maksimalt respons opnås normalt inden for 4 uger.
English: These changes were usually mild, transient, and did not require interruption of treatment.
Danish: Disse ændringer er sædvanligvis milde og forbigående og fører ikke til afbrydelse af behandlingen.
English: Therefore, they cannot be extrapolated to the lower dose strengths.
Danish: Derfor kan de ikke ekstrapoleres til de lavere doser.
English: Treatment was initiated during the acute phase after hospital admission and lasted for a period of 16 weeks.
Danish: Behandling blev initieret i den akutte fase under hospitalindlæggelse og blev fortsat i 16 uger.
English: Increase is indicated as “↑”, decrease as “↓”
Danish: Stigning er vist som “↑”, nedsættelse som “↓”
English: The safety and tolerability profiles of the two treatment groups were comparable.
Danish: Sikkerheds- og tolerabilitetsprofilen var sammenlignelig i de 2 grupper.
English: These elevations were dose related and were reversible in all patients.
Danish: Disse forhøjelser var dosisafhængige og var reversible hos alle patienter.
English: Prevention of cardiovascular disease
Danish: Forebyggelse af kardiovaskulær sygdom
English: Clinical Recommendation#
Danish: Klinisk rekommandation#
English: If possible, alternative (non-interacting) therapies should be considered instead of these medicinal products.
Danish: Alternative behandlinger (uden interaktion) bør overvejes i stedet for disse lægemidler, hvis det er muligt.
English: Therefore, the clinical significance of these imaging results with regard to the primary and secondary prevention of cardiovascular events is unknown.
Danish: Derfor er den kliniske relevans af disse resultater med hensyn til primær og sekundær forebyggelse af kardiovaskulære hændelser ikke kendt.
English: Apart from other pathways these products are further metabolized via glucuronidation.
Danish: Uafhængigt af andre omsætningsveje metaboliseres disse produkter yderligere via glukuronidering.
English: Rare: peripheral neuropathy.
Danish: Sjælden: Perifer neuropati.
English: Higher doses may be necessary in order to attain (LDL-) cholesterol levels according to current guidelines.
Danish: Højere doser kan være nødvendige for at opnå LDL-kolesterolniveauer i henhold til gældende guidelines.
English: A genetically impaired hepatic uptake of atorvastatin is also possible in these patients.
Danish: En genetisk forårsaget nedsat hepatisk optagelse af atorvastatin er også mulig hos disse patienter.
English: Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can change the effects of {PRODUCT NAME}.
Danish: De må ikke tage mere end 1-2 små glas grapefrugtjuice dagligt, da store mængder grapefrugtjuice kan påvirke virkningen af Zarator.
English: Patients should be closely monitored and temporary suspension of atorvastatin treatment may be appropriate.
Danish: Patienterne bør monitoreres tæt, og midlertidig seponering af atorvastatin kan være hensigtsmæssig.
English: Atorvastatin is rapidly absorbed after oral administration; maximum plasma concentrations (Cmax) occur within 1 to 2 hours.
Danish: Atorvastatin absorberes hurtigt efter oral indgift; maksimal plamakoncentration (Cmax) nås inden for 1-2 timer.
English: Absolute Risk Reduction1
Danish: Absolut risikoreduktion1 (%)
English: Therefore, this SPC, labelling and package leaflet may not necessarily represent the current text.
Danish: Derfor repræsenterer dette produktresumé, denne etikettering og denne indlægsseddel ikke nødvendigvis den aktuelle tekst.
English: The dose may be increased to 80 mg daily, according to the response and tolerability.
Danish: Dosis kan øges til 80 mg dagligt i henhold til respons og tolerabilitet.
English: No. of Events (Atorvastatin vs Placebo)
Danish: Antal hændelser (Atorvastatin vs. placebo)
English: Paediatric: Pharmacokinetic data in the paediatric population are not available.
Danish: Pædiatrisk population: Der er ikke farmakokinetiske data tilgængelige for den pædiatriske population.
English: These differences were of no clinical significance, resulting in no clinically significant differences in lipid effects among men and women.
Danish: Disse forskelle havde ingen klinisk betydning og resulterede ikke i nogen klinisk signifikante forskelle i den lipidregulerende virkning mellem kønnene.
English: In such situations, the risk of treatment should be considered in relation to possible benefit, and clinical monitoring is recommended.
Danish: I sådanne tilfælde skal risikoen ved behandlingen vurderes i forhold til den mulige fordel, og klinisk monitorering anbefales.
English: In the atorvastatin group (n=253), there was no progression of atherosclerosis.
Danish: I atorvastatingruppen (n=253) var der ingen progression af aterosklerose.
English: Before the treatment
Danish: Før behandling
English: Efficacy and safety in patients older than 70 using recommended doses are similar to those seen in the general population.
Danish: Virkning og sikkerhed af de anbefalede doser til ældre patienter over 70 år svarer til det, som ses hos den almindelige befolkning.