FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee decided that Cystadane's benefits outweighed its risks in the adjunctive treatment of homocystinuria, when it is used according to its indication.
Danish: Udvalget konkluderede, at fordelene ved Cystadane opvejer risiciene, når det anvendes i henhold til indikationen som tillægsbehandling ved homocystinuri.
English: Cystadane betaine anhydrous
Danish: Cystadane betain, vandfri
English: For practical information about using Cystadane, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Cystadane, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Cystadane used?
Danish: Hvordan anvendes Cystadane?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cystadane 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 Cystadane.
English: What benefits of Cystadane have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Cystadane?
English: How does Cystadane work?
Danish: Hvordan virker Cystadane?
English: This might be necessary if patients need to be able to start to breathe on their own again during the operation.
Danish: Dette kan være nødvendigt, hvis patienterne er nødt til at begynde selv at trække vejret i løbet af operationen.
English: This dose is expected to be used in only a limited number of the treatments (less than 1%).
Danish: Det forventes, at denne dosis kun vil blive anvendt i et begrænset antal tilfælde (mindre end 1 %).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bridion on 25 July 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Bridion den 25. juli 2008.
English: The full EPAR for Bridion can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Bridion findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Bridion.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Bridion.
English: A risk management plan has been developed to ensure that Bridion is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Bridion anvendes så sikkert som muligt.
English: Other information about Bridion
Danish: Andre oplysninger om Bridion
English: There were too few children aged below two years to determine the safety and effectiveness of Bridion in this age group.
Danish: Der var for få børn under to år til at bestemme sikkerhed og virkning af Bridion i den aldersgruppe.
English: In all of the studies, the main measure of effectiveness was how long it took for the muscles to recover.
Danish: I alle undersøgelser var det primære mål for virkning, hvor lang tid det tog musklerne at vågne op igen.
English: What measures are being taken to ensure the safe and effective use of Bridion?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Bridion?
English: Muscle relaxants make it easier for the surgeon to do the operation.
Danish: Muskelafslappende midler gør det lettere for kirurgen at foretage operationen.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Bridion.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Bridion skal anvendes.
English: For more information about treatment with Bridion, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Bridion, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Bridion can only be given by or under the supervision of an anaesthetist (a doctor specialised in anaesthesia).
Danish: Bridion kan kun indgives af eller under overvågning af en anæstesilæge (en læge, der er specialiseret i bedøvelse).
English: In children and adolescents from two to 17 years of age, the recommended dose is 2 mg/kg body weight.
Danish: Den anbefalede dosis til børn og unge fra to til 17 år er 2 mg/kg kropsvægt.
English: The CHMP decided that Bridion's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Bridion opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Bridion.
English: The effect of Bridion seen in adults was similar in adolescents and children aged over two years.
Danish: Virkningen af Bridion hos voksne var den samme hos unge og børn over to år.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bridion, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Bridion, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Bridion is a solution for injection that contains the active substance sugammadex (100 mg/ml).
Danish: Bridion er en opløsning til injektion, der indeholder det aktive stof sugammadex (100 mg/ml).
English: Muscle relaxants are medicines used during some types of operation to make the muscles relax, including the muscles that help the patient to breathe.
Danish: Muskelafslappende midler er lægemidler, der anvendes til visse operationer for at få musklerne til at slappe af, herunder de muskler, der hjælper patienten med at trække vejret.
English: The most common side effects with Bridion (seen in between 1 and 10 patients in 100) are cough, airway problems due to the anaesthesia wearing off, reduced blood pressure and other complications such as changes in heart rate.
Danish: De hyppigste bivirkninger ved Bridion (forekommer hos mellem 1 og 10 ud af 100 patienter) er hoste, vejrtrækningsproblemer, når virkningen af bedøvelsen begynder at aftage, nedsat blodtryk og andre komplikationer såsom ændringer i hjerterytmen.
English: The standard dose of Bridion is between 2 and 4 mg per kilogram body weight, depending on how much the muscle relaxant is affecting the muscles.
Danish: Den typiske dosis Bridion er 2-4 mg pr. kg. kropsvægt, afhængigt af i hvor høj grad det muskelafslappende middel påvirker musklerne.
English: A dose of 16 mg/kg can be used if rapid recovery from muscle relaxation is needed.
Danish: En dosis på 16 mg/kg kan anvendes, hvis en hurtig ophævelse af det muskelafslappende middels virkning er nødvendig.
English: Bridion can be used in adults who have received rocuronium and vecuronium, and in children and adolescents who have received rocuronium.
Danish: Bridion kan anvendes hos voksne, der har fået rocuronium og vecuronium, og hos børn og unge, der har fået rocuronium.
English: Bridion must not be used in people who are hypersensitive (allergic) to sugammadex or any of the other ingredients.
Danish: Bridion bør ikke anvendes til personer, der kan være overfølsomme (allergiske) over for sugammadex eller andre af indholdsstofferne.
English: Bridion has been studied in four main studies in a total of 579 adults undergoing surgery using muscle relaxants.
Danish: Bridion blev undersøgt i fire hovedundersøgelser med i alt 579 voksne patienter, der fik muskelafslappende midler under operation.
English: It is given as a single intravenous ‘bolus' injection (given into a vein all at once).
Danish: Det gives som en enkelt intravenøs bolusinjektion (dvs. en indsprøjtning af al lægemidlet på én gang i en blodåre).
English: After moderate muscle relaxation, the average time for recovery was between 1.4 and 2.1 minutes for 2 mg/kg Bridion, compared with 17.6 to 18.9 minutes for neostigmine.
Danish: Efter moderat muskelafslapning var den gennemsnitlige genopvågningstid mellem 1,4 og 2,1 minutter for 2 mg/kg Bridion sammenlignet med 17,6 til 18,9 minutter for neostigmin.
English: For the full list of all side effects reported with Bridion, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Bridion fremgår af indlægssedlen.
English: What is the risk associated with Bridion?
Danish: Hvilken risiko er der forbundet med Bridion?
English: This was compared with spontaneous recovery after muscle relaxation using succinylcholine (another muscle relaxant).
Danish: Dette blev sammenlignet med spontan genopvågning efter muskelafslapning fremkaldt af succinylkolin (et andet muskelafslappende middel).
English: As a result, the effect of blockade of the muscles due to rocuronium and vecuronium on the muscles is reversed, and the muscles begin to work normally again, including the muscles that help the patient to breathe.
Danish: Som følge deraf ophæves den muskelblokade, der er fremkaldt af rocuronium og vecuronium, og musklerne begynder at fungere normalt igen, herunder de muskler, der hjælper patienten med at trække vejret.
English: In contrast, muscle relaxation recovered spontaneously after 7.1 minutes.
Danish: Til sammenligning var den spontane genopvågningstid efter muskelafslapning 7,1 minutter.
English: Why has Bridion been approved?
Danish: Hvorfor blev Bridion godkendt?
English: An additional study looked at the effectiveness of Bridion given after rocuronium in 90 children and adolescents.
Danish: I en yderligere undersøgelse så forskerne nærmere på virkningen af Bridion givet efter rocuronium hos 90 børn og unge.
English: When used for rapid recovery, patients receiving 16 mg/kg Bridion recovered after 4.2 minutes.
Danish: Når midlet blev brugt til hurtig genopvågning, vågnede de patienter, der fik 16 mg/kg Bridion, op efter 4,2 minutter.
English: After deep muscle relaxation, recovery took an average of around 3.0 minutes with 4 mg/kg Bridion, compared with around 49.5 minutes for neostigmine.
Danish: Efter dyb muskelafslapning var den gennemsnitlige genopvågningstid ca. 3,0 minutter med 4 mg/kg Bridion sammenlignet med ca. 49,5 minutter for neostigmin.
English: This means that it attaches to the muscle relaxants rocuronium and vecuronium forming a ‘complex' that inactivates the muscle relaxants and stops them having an effect.
Danish: Det betyder, at det binder til muskelafslapningsmidlerne rocuronium og vecuronium og derved udgør et kompleks, der inaktiverer muskelafslapningsmidlerne og forhindrer dem i at virke.
English: The active substance in Bridion, sugammadex, is a ‘selective relaxant binding agent'.
Danish: Det aktive stof i Bridion, sugammadex, er et stof, der binder sig selektivt til det muskelafslappende middel.
English: Bridion is not recommended for use in children and adolescents for recovery after vecuronium, or for rapid recovery after any muscle relaxant.
Danish: Bridion er ikke anbefalet til brug hos børn og unge med henblik på genopvågning efter bedøvelse med vecuronium eller hurtig genopvågning efter et hvilket som helst muskelafslappende middel.
English: What is Bridion?
Danish: Hvad er Bridion?
English: Bridion was compared with neostigmine (another medicine used to stop the effect of muscle relaxants) given after rocuronium or vecuronium in the first study and after cis-atracurium (another muscle relaxant) in the second.
Danish: Bridion blev sammenlignet med neostigmin (et andet lægemiddel til ophævelse af virkningen af muskelafslappende midler) givet efter rocuronium eller vecuronium i den første undersøgelse og efter cis-atracurium (et andet muskelafslappende middel) i den anden undersøgelse.
English: The third study compared the effectiveness of 4 mg/kg Bridion with that of neostigmine after deep relaxation of the muscles using rocuronium or vecuronium in 182 patients.
Danish: I den tredje undersøgelse sammenlignedes virkningen af 4 mg/kg Bridion med neostigmins virkning efter dyb muskelafslapning ved brug af rocuronium eller vecuronium hos 182 patienter.
English: Bridion was more effective than neostigmine in reducing the time it took for the muscles to recover, after both moderate and deep muscle relaxation using rocuronium or vecuronium.
Danish: Bridion var mere effektivt end neostigmin til at forkorte den tid, det tog musklerne at vågne op igen, efter såvel moderat som dyb muskelafslapning fremkaldt af rocuronium eller vecuronium.
English: Bridion is used to speed up the recovery from the muscle relaxant, usually at the end of the operation.
Danish: Bridion anvendes til at gøre genopvågningstiden efter indgift af muskelafslapningsmidlet kortere, typisk ved slutningen af en operation.
English: The fourth study, involving 115 patients, looked at the effectiveness of 16 mg/kg Bridion in producing rapid reversal of the muscle relaxation using rocuronium.
Danish: I den fjerde undersøgelse, hvori 115 patienter deltog, så forskerne nærmere på virkningen af 16 mg/kg Bridion, for så vidt angår hurtig ophævelse af muskelafslapningen fremkaldt af rocuronium.
English: What benefit has Bridion shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Bridion?
English: Two of the studies, involving a total of 282 patients, looked at the effectiveness of 2 mg/kg Bridion in reversing moderate relaxation of the muscles due to rocuronium or vecuronium.
Danish: I to af undersøgelserne, hvori 282 patienter i alt deltog, så forskerne nærmere på virkningen af 2 mg/kg Bridion i forhold til at ophæve en moderat afslapning af musklerne fremkaldt af rocuronium eller vecuronium.
English: What is Bridion used for?
Danish: Hvad anvendes Bridion til?
English: How has Bridion been studied?
Danish: Hvordan blev Bridion undersøgt?
English: How is Bridion used?
Danish: Hvordan anvendes Bridion?
English: How does Bridion work?
Danish: Hvordan virker Bridion?
English: Bridion is used to reverse the effect of the muscle relaxants rocuronium and vecuronium.
Danish: Bridion anvendes til at ophæve virkningen af lægemidlerne rocuronium og vecuronium, der får musklerne til at slappe af.
English: Further information on Segluromet can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Segluromet findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The dose is one tablet twice a day with food.
Danish: Den anbefalede dosis er én tablet to gange dagligt sammen med måltider.
English: Segluromet is available as tablets in 4 strengths of ertugliflozin and metformin (2.5 mg/850 mg, 2.5 mg/1,000 mg, 7.5 mg/850 mg and 7.5 mg/1,000 mg).
Danish: Segluromet fås som tabletter i 4 styrker af ertugliflozin og metformin (2,5 mg/850 mg, 2,5 mg/1000 mg, 7,5 mg/850 mg og 7,5 mg/1000 mg).
English: Other information about Segluromet
Danish: Andre oplysninger om Segluromet
English: As for all medicines, data on the use of Segluromet is continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Segluromet løbende overvåget.
English: The doctor will check how well the patient's kidneys are working before treatment and once a year during treatment.
Danish: Lægen vil kontrollere patientens nyrefunktion før behandlingen og én gang om året under behandlingen.
English: Segluromet (ertugliflozin / metformin hydrochloride)
Danish: Segluromet (ertugliflozin/metforminhydrochlorid)
English: The European Medicines Agency concluded that Segluromet'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 Segluromet opvejer risiciene, og det kan godkendes til anvendelse i EU
English: For more information about using Segluromet, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Segluromet, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Segluromet can also help some patients lose weight.
Danish: Segluromet kan desuden hjælpe nogle patienter til at tabe sig
English: What measures are being taken to ensure the safe and effective use of Segluromet?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Segluromet?
English: An overview of Segluromet and why it is authorised in the EU
Danish: En oversigt over Segluromet og hvorfor det er godkendt i EU
English: Side effects reported with Segluromet are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Segluromet vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: It must also not be used in patients with severe kidney problems or certain heart, circulatory, breathing or liver problems and in patients who drink alcohol to excess.
Danish: Det må heller ikke anvendes hos patienter med svære nyreproblemer eller visse hjerte-, kredsløbs-, vejrtræknings- eller leverproblemer, eller hos patienter med et overdrevent alkoholforbrug.
English: Why is Segluromet authorised in the EU?
Danish: Hvorfor blev Segluromet godkendt i EU?
English: The most common side effects with Segluromet (which may affect more than 1 in 10 people) are fungal infections of the vagina and other infections of the female reproductive system and problems with the gut such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite.
Danish: De hyppigste bivirkninger ved Segluromet (som kan forekomme hos mere end 1 ud af 10 personer) er svampeinfektioner i skeden og andre infektioner i de kvindelige kønsorganer samt mave-tarmproblemer såsom kvalme, opkastning, diarré, mavesmerter og appetitløshed.
English: Segluromet can only be obtained with a prescription.
Danish: Segluromet udleveres kun efter recept.
English: The dose of Segluromet may be reduced or it may be stopped if the kidneys are not working well enough.
Danish: Dosis af Segluromet kan sættes ned eller stoppes, hvis nyrerne ikke fungerer godt nok.
English: What is Segluromet and what is it used for?
Danish: Hvad er Segluromet, og hvad anvendes det til?
English: What are the risks associated with Segluromet?
Danish: Hvilke risici er der forbundet med Segluromet?
English: Four main studies in over 3,600 patients with type 2 diabetes have shown that adding ertugliflozin to metformin helps lower glucose levels when metformin is not working well enough.
Danish: Fire hovedstudier med i alt over 3600 patienter med type 2-sukkersyge har vist, at tilføjelse af ertugliflozin til metformin sænker glukoseniveauet, når metformin ikke virker godt nok.
English: Segluromet must not be used in patients with uncontrolled diabetes with severe symptoms that lead to high acid levels in the blood.
Danish: Segluromet må ikke anvendes hos patienter, der har ureguleret sukkersyge med svære symptomer, som fører til stort syreindhold i blodet.
English: • patients whose glucose levels are not well controlled with the highest dose of metformin they can take
Danish: • patienter, hvis glukoseniveau ikke er velreguleret på den højeste dosis metformin, de kan tåle
English: In this study, HbA1c levels fell by 0.6 points with ertugliflozin and 0.7 points with glimepiride.
Danish: I dette studie faldt HbA1c-niveauet med 0,6 point med ertugliflozin og 0,7 point med glimepirid.
English: Studies showed that Segluromet can help lower glucose levels in patients whose metformin treatment is not working well enough, including those taking another diabetes medicine in addition to metformin.
Danish: Studierne viste, at Segluromet kan være med til at nedsætte glukoseniveauet hos patienter, hos hvem behandling med metformin ikke virker godt nok, også dem, der tager anden sukkersygemedicin foruden metformin.
English: Segluromet is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes.
Danish: Segluromet er lægemiddel mod sukkersyge og anvendes til regulering af blodets indhold af sukker (glukose) hos voksne med type 2-sukkersyge.
English: The strength of Segluromet tablet to use depends on how well the patient's glucose levels are controlled.
Danish: Den styrke af Segluromet-tabletter, der skal anvendes, afhænger af, hvor velreguleret patientens blodsukker er.
English: How is Segluromet used?
Danish: Hvordan anvendes Segluromet?
English: Treatment will not be started if the kidney function is poor.
Danish: Hvis nyrefunktionen er dårlig, vil behandlingen ikke blive påbegyndt.
English: HbA1c levels fell by between 0.8 and 0.9 percentage points when ertugliflozin was added, compared with a fall of 0.1 with placebo
Danish: HbA1c-niveauet faldt mellem 0,8 og 0,9 procentpoint, når der blev tilføjet ertugliflozin, sammenholdt med et fald på 0,1 med placebo.
English: For the full list of side effects of Segluromet, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger med Segluromet fremgår af indlægssedlen.
English: • The fourth study found that, in patients taking metformin, adding ertugliflozin was as effective as adding sitagliptin with HbA1c levels falling by around 1 point with both treatments.
Danish: • Det fjerde studie viste, at hos patienter, der fik metformin, var tilføjelse af ertugliflozin lige så effektivt som tilføjelse af sitagliptin, idet HbA1c-niveauet faldt med ca. 1 point med begge behandlinger.
English: Metformin, on the other hand, works mainly by blocking glucose production in the body and by reducing the absorption of glucose in the gut.
Danish: Metformin virker derimod hovedsagelig ved at blokere produktionen af glukose i kroppen og nedsætte glukoseoptagelsen fra mave-tarmkanlen.
English: The two active substances in Segluromet, ertugliflozin and metformin, work in different ways to lower glucose levels.
Danish: De to aktive stoffer i Segluromet, ertugliflozin og metformin, sænker glukoseindholdet på hver sin måde:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Segluromet 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 Segluromet.
English: • The first study found that in patients taking a combination of ertugliflozin and metformin, HbA1c levels fell by around 0.8 points, compared with reductions of 0.03 when placebo (a dummy treatment) was added to metformin.
Danish: • Det første studie viste, at hos patienter, der fik en kombination af ertugliflozin og metformin, faldt HbA1c-niveauet med ca. 0,8 point, sammenholdt med et fald på 0,03, når der i stedet blev tilføjet virkningsløs behandling (placebo) til metformin.
English: Steglatro is not as effective in patients with moderate kidney impairment and should therefore not be started in such patients.
Danish: Hos patienter med moderat nedsat nyrefunktion er Segluromet ikke lige så effektivt; sådanne patienter bør derfor ikke sættes i behandling med det.
English: • patients on the highest dose of metformin they can take who are also taking another diabetes medicine
Danish: • patienter, der får den højeste dosis metformin, de kan tåle, og som i forvejen også får et andet sukkersygelægemiddel
English: What benefits of Segluromet have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Segluromet?
English: Ertugliflozin helps to lower blood glucose by making the patient pass out glucose in the urine.
Danish: Ertugliflozin sænker blodglukose ved at fremkalde udskillelse af glukose i urinen.