FrancophonIA/ELRC3.0 huggingface dataset:
English: Mepact is given as a slow infusion lasting an hour.
Danish: Mepact gives som en langsom infusion i løbet af en periode på en time.
English: Because the number of patients with osteosarcoma is low, the disease is considered ‘rare', and Mepact was designated an ‘orphan medicine' (a medicine used in rare diseases) on 21 June 2004.
Danish: Da antallet af patienter med osteosarkom er lavt, betragtes sygdommen som "sjælden", og Mepact blev udpeget som "lægemiddel til sjældne sygdomme" den 21. juni 2004.
English: For more information about treatment with Mepact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Mepact, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It must not be given as a bolus injection (all at once).
Danish: Det må ikke gives som en bolusinjektion (hele dosen på én gang).
English: Mepact, used with other anticancer medicines, increased how long patients survived without their disease coming back: 68% of the patients receiving Mepact (231 out of 338) survived without the disease coming back, compared with 61% of the patients who did not receive it (207 out of 340).
Danish: Når Mepact blev anvendt sammen med andre lægemidler mod kræft, forlængede det den tid, patienterne overlevede, uden at deres sygdom vendte tilbage: 68 % af de patienter, som fik Mepact (231 ud af 338), overlevede, uden at deres sygdom vendte tilbage, sammenlignet med 61 % af de patienter, som ikke fik lægemidlet (207 ud af 340).
English: After surgery to remove the cancer, all of the patients were given various combinations of anticancer medicines.
Danish: Efter kirurgisk fjernelse af det kræftramte område fik alle patienterne forskellige kombinationer af lægemidler mod kræft.
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 Mepact.
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 anvendelsesbetingelserne for Mepact.
English: It works by activating macrophages and monocytes (types of white blood cell that form part of the immune system).
Danish: Det virker ved at aktivere makrofager og monocytter (typer af hvide blodlegemer, som udgør en del af immunsystemet).
English: It must not be used at the same time as ciclosporin or other calcineurin inhibitors (medicines that reduce the activity of the immune system), or high doses of non-steroidal anti-inflammatory drugs (NSAIDs; used to treat pain and inflammation).
Danish: Det må ikke anvendes samtidig med ciclosporin eller andre calcineurinhæmmere (lægemidler, som reducerer immunsystemets aktivitet) eller høje doser af nonsteroide anti-inflammatoriske lægemidler (NSAID'er, der anvendes til behandling af smerter og betændelse).
English: The precise way that mifamurtide works in osteosarcoma is not fully understood, but it is thought to cause the white blood cells to release chemicals that kill the cancerous cells.
Danish: Det vides ikke præcist, hvordan mifamurtid virker mod osteosarkom, men det menes at få de hvide blodlegemer til at frigive kemiske stoffer, som ødelægger kræftcellerne.
English: The active substance in Mepact, mifamurtide, is an immunomodulator.
Danish: Det aktive stof i Mepact, mifamurtid, er en immunmodulator.
English: Mepact treatment should be started and supervised by a specialised doctor who has experience in diagnosing and treating osteosarcoma.
Danish: Behandling med Mepact bør iværksættes og overvåges af speciallæger med erfaring i diagnosticering og behandling af osteosarkom.
English: The full EPAR for Mepact can be found here.
Danish: Den fuldstændige EPAR for Mepact findes her.
English: Mepact is used with other anticancer medicines after the cancer has been removed by surgery.
Danish: Mepact anvendes med andre lægemidler mod kræft, efter at det kræftramte område er blevet fjernet kirurgisk.
English: Mepact is used to treat high-grade non-metastatic osteosarcoma (a type of bone cancer) in patients aged between two and 30 years.
Danish: Mepact anvendes til behandling af højt differentieret ikke-metastatisk osteosarkom (en type knoglekræft) hos patienter i alderen mellem to og 30 år.
English: Mepact is a powder that is made up into a suspension for infusion (drip into a vein).
Danish: Mepact er et pulver, der blandes til en opløsning til infusion (drop i en vene).
English: Mepact has been studied in one main study involving 678 patients aged between one and 31 years with high-grade non-metastatic osteosarcoma.
Danish: Mepact blev undersøgt i en hovedundersøgelse, som omfattede 678 patienter i alderen mellem et og 31 år med højt differentieret ikke-metastatisk osteosarkom.
English: It contains the active substance mifamurtide.
Danish: Det indeholder det aktive stof mifamurtid.
English: What is the risk associated with Mepact?
Danish: Hvilken risiko er der forbundet med Mepact?
English: Mepact should not be used in people who may be hypersensitive (allergic) to mifamurtide or any of the other ingredients.
Danish: Mepact bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for mifamurtid eller andre af indholdsstofferne.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Mepact is available here.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Mepact findes her.
English: The CHMP decided that Mepact's benefits are greater than its risks when used with other anticancer medicines and recommended that it be given marketing authorisation.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Mepact opvejer risiciene, når det anvendes sammen med andre lægemidler mod kræft, og anbefalede udstedelse af markedsføringstilladelse for Mepact.
English: For the full list of all side effects reported with Mepact, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Mepact fremgår af indlægssedlen.
English: Why has Mepact been approved?
Danish: Hvorfor blev Mepact godkendt?
English: What is Mepact?
Danish: Hvad er Mepact
English: What is Mepact used for?
Danish: Hvad anvendes Mepact til?
English: How has Mepact been studied?
Danish: Hvordan blev Mepact undersøgt?
English: What benefit has Mepact shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Mepact?
English: How does Mepact work?
Danish: Hvordan virker Mepact?
English: How is Mepact used?
Danish: Hvordan anvendes Mepact?
English: 74.2 mg Implant
Danish: 74,2 mg Implantat
English: 4 implants + 1 applicator
Danish: 4 implantater + 1 applikator
English: Subcutaneous use sachet (PET/LDPE/alu)
Danish: Subkutan anvendelse Brev (PET/LDPE/Alu)
English: EU/1/19/1369/001 Sixmo
Danish: ,MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administrationsvej Indre emballage Pakningsstørrelse EU/1/19/1369/001 Sixmo
English: Studies lasted for six months or one year.
Danish: Undersøgelserne varede seks måneder eller et år.
English: The correct dose is determined individually for each patient.
Danish: Den korrekte dosis fastlægges for hver enkelt patient.
English: After 26 weeks of treatment, patients had the option to either stop treatment or continue with it for up to a year.
Danish: Efter 26 ugers behandling kunne patienterne enten vælge at stoppe behandlingen eller fortsætte den i op til et år.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tresiba on 21 January 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tresiba den 21. januar 2013.
English: The full EPAR for Tresiba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Tresiba findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Tresiba.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tresiba.
English: Tresiba is injected once a day, preferably at the same time every day.
Danish: Tresiba injiceres én gang dagligt, helst på samme tidspunkt hver dag.
English: A risk management plan has been developed to ensure that Tresiba is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Tresiba anvendes så sikkert som muligt.
English: It is available as a solution for injection in a cartridge (100 units/ml) and in a pre-filled pen (100 units/ml and 200 units/ml).
Danish: Det fås som en injektionsvæske, opløsning, der leveres i en cylinderampul (100 enheder/ml) og i en fyldt pen (100 enheder/ml og 200 enheder/ml).
English: For more information about treatment with Tresiba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Tresiba, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of Tresiba?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tresiba?
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 Tresiba.
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 Tresiba skal anvendes.
English: Other information about Tresiba
Danish: Andre oplysninger om Tresiba:
English: After 26 weeks of treatment with Tresiba, the average reduction in HbA1c was 0.2 percentage points (HbA1c decreased from 8.2% to 8.0%) compared with a reduction of 0.3 percentage points with insulin detemir (HbA1c decreased from 8.0% to 7.7%).
Danish: Efter 26 ugers behandling med Tresiba var det gennemsnitlige fald i indholdet af HbA1c 0,2 procentpoint (indholdet af HbA1c faldt fra 8,2 % til 8,0 %) sammenlignet med et fald på 0,3 procentpoint med insulin detemir (indholdet af HbA1c faldt fra 8,0 % til 7,7 %).
English: Tresiba is a medicine that contains the active substance insulin degludec.
Danish: Tresiba er et lægemiddel, der indeholder det aktive stof insulin degludec.
English: The CHMP noted that the higher strength formulation of Tresiba met a medical need for patients requiring higher dose insulin (such as overweight patients), which would allow these patients to take their daily dose in a single injection rather than two injections.
Danish: CHMP bemærkede, at den højere styrke af Tresiba opfylder et behandlingsbehov hos patienter, der kræver højere dosis insulin (såsom overvægtige patienter), da disse patienter dermed kan tage den daglige dosis i én enkelt injektion i stedet for to injektioner.
English: Regarding its safety, the Committee concluded that Tresiba is generally safe and its side effects are comparable to those of other insulin analogues with no unexpected side effects reported.
Danish: Vedrørende sikkerheden konkluderede udvalget, at Tresiba generelt er sikkert, at dets bivirkninger er sammenlignelige med bivirkningerne ved andre insulinanaloger, og at der ikke er indberettet uventede bivirkninger.
English: Patients were also given rapid-acting insulin at mealtimes.
Danish: Patienterne fik også hurtigtvirkende insulin ved måltiderne.
English: The CHMP decided that Tresiba's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Tresiba opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Tresiba.
English: Tresiba is a replacement insulin that is very similar to the natural insulin with a difference that it is absorbed more slowly in the body and takes longer to reach its target.
Danish: Tresiba er en insulinerstatning, der ligner naturligt dannet insulin meget, blot med den forskel, at det optages langsommere i kroppen og er længere om at nå frem til målvævet.
English: For adolescents with type 2 diabetes, the CHMP concluded that although safety and effectiveness had only been shown for type 1 diabetes, the results of studies carried out in adolescents with type 1 and other studies in adults with type 2 diabetes could be applied to adolescents with type 2.
Danish: For unge med type 2-diabetes konkluderede CHMP, at selv om sikkerheden og virkningen kun var blevet påvist for type 1-diabetes, kunne resultaterne af undersøgelserne hos unge med type 1-diabetes og andre undersøgelser hos voksne med type 2-diabetes anvendes på unge med type 2-diabetes.
English: For the full list of side effects and restrictions with Tresiba, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Tresiba fremgår af indlægssedlen.
English: What is the risk associated with Tresiba?
Danish: Hvilken risiko er der forbundet med Tresiba?
English: Patients in these studies could also be given other diabetes medicines or rapid-acting insulin at mealtimes if needed.
Danish: Patienterne i disse undersøgelser kunne derudover efter behov få anden sukkersygemedicin eller hurtigvirkende insulin i forbindelse med måltiderne.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tresiba, 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 Tresiba, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The company that markets Tresiba will provide educational materials to healthcare professionals expected to treat or dispense medicines to patients with diabetes, aimed particularly at raising awareness of the higher strength formulation of Tresiba in order to ensure that the patient is prescribed the correct strength.
Danish: Den virksomhed, der markedsfører Tresiba, skal udlevere oplysningsmateriale til sundhedspersoner, der forventes at behandle sukkersygepatienter eller udlevere lægemidler til dem, navnlig med henblik på at gøre opmærksom på den større styrke af Tresiba og sikre, at patienterne får ordineret den korrekte styrke.
English: All of the studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood attached to glucose.
Danish: I alle undersøgelserne måltes blodets indhold af glykosyleret hæmoglobin (HbA1c), dvs. den procentdel af blodets hæmoglobin, der er bundet til glukose (sukker).
English: The most frequently reported side effect during treatment with Tresiba (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose levels).
Danish: Den hyppigste bivirkning ved Tresiba (som optræder hos flere end 1 ud af 10 patienter) er hypoglykæmi (for lavt blodsukker).
English: In addition Tresiba was compared with insulin detemir in one main study involving 350 children aged 1 to 18 years of age with type 1 diabetes.
Danish: Tresiba blev desuden sammenlignet med insulin detemir i en hovedundersøgelse med 350 børn i alderen 1-18 år med type 1-diabetes.
English: In type 1 diabetes, Tresiba must always be used in combination with rapid acting insulin, which is injected at mealtimes.
Danish: Ved type 1-diabetes skal Tresiba altid anvendes i kombination med hurtigtvirkende insulin, som injiceres i forbindelse med måltiderne.
English: Why has Tresiba been approved?
Danish: Hvorfor blev Tresiba godkendt?
English: Across the studies, the average reduction in HbA1c levels with Tresiba treatment was 0.6 percentage points in adults with type 1 diabetes and 1.2 points in adults with type 2 diabetes.
Danish: I alle undersøgelserne under ét var den gennemsnitlige mindskelse af indholdet af HbA1c ved behandling med Tresiba 0,6 procentpoint hos voksne med type 1-diabetes og 1,2 procentpoint hos voksne med type 2-diabetes.
English: It is given as an injection under the skin in the thigh, upper arm or abdominal wall (at the front of the waist).
Danish: Det gives ved en injektion under huden i låret, overarmen eller maveskindet.
English: Another main study involving 177 adults with type 2 diabetes investigated the effectiveness of combining Tresiba and liraglutide (a GLP-1 receptor agonist).
Danish: I en anden hovedundersøgelse, der omfattede 177 voksne med type 2-diabetes, undersøgte man virkningen af at kombinere Tresiba og liraglutid (en GLP-1-receptoragonist).
English: Tresiba has been studied in three main studies involving 1,578 adults with type 1 diabetes, where Tresiba (in combination with rapid acting mealtime insulin) was compared with insulin glargine or insulin detemir (other long acting insulins).
Danish: Tresiba blev undersøgt i tre hovedundersøgelser, der omfattede 1 578 voksne med type 1-diabetes, hvor Tresiba (i kombination med hurtigvirkende insulin) blev sammenlignet med insulin glargin eller insulin detemir (andre langtidsvirkende insuliner).
English: Tresiba acts in the same way as naturally produced insulin and helps glucose enter cells from the blood.
Danish: Tresiba virker på samme måde som naturligt dannet insulin og bevirker, at sukkeret fra blodet føres ind i cellerne.
English: What is Tresiba?
Danish: Hvad er Tresiba?
English: The studies showed that Tresiba was at least as effective as other long acting insulins in controlling blood glucose levels in adults with type 1 and type 2 diabetes, and more effective than sitagliptin in adults with type 2 diabetes.
Danish: Undersøgelserne viste, at Tresiba var mindst lige så effektivt som andre langtidsvirkende insuliner til at regulere blodsukkeret hos voksne med type 1- og type 2-diabetes og mere effektivt end sitagliptin hos voksne med type 2-diabetes.
English: In type 2 diabetes, Tresiba can be used alone or in combination with diabetes medicines given by mouth, GLP-1 receptor agonist medicines and rapid acting mealtime insulin.
Danish: Ved type 2diabetes kan Tresiba anvendes alene eller i kombination med oral sukkersygemedicin, lægemidler indeholdende GLP-1-receptoragonister samt hurtigtvirkende måltidsinsulin.
English: In children, the effects of Tresiba on blood glucose control were similar to those of insulin detemir.
Danish: Hos børn havde Tresiba samme virkning på reguleringen af blodsukkeret som insulin detemir.
English: This means that Tresiba has a long duration of action.
Danish: Derfor holder virkningen af Tresiba sig længere.
English: It also noted that Tresiba reduces the risk of hypoglycaemia during the night in patients with type 1 and type 2 diabetes.
Danish: Udvalget bemærkede desuden, at Tresiba nedsætter risikoen for natlig hypoglykæmi hos patienter med type 1- og type 2-diabetes.
English: Six other main studies involving 4,076 adults with type 2 diabetes compared Tresiba with insulin glargine, insulin detemir or sitagliptin (a medicine taken by mouth for type 2 diabetes).
Danish: I seks yderligere hovedundersøgelser, der omfattede 4 076 voksne med type 2-diabetes, blev Tresiba sammenlignet med insulin glargin, insulin detemir eller sitagliptin (medicin mod type 2-diabetes, der indtages gennem munden).
English: The CHMP concluded that Tresiba is effective in controlling blood glucose levels in patients with type 1 and type 2 diabetes.
Danish: CHMP konkluderede, at Tresiba er effektivt til at regulere blodsukkeret hos patienter med type 1- og type 2-diabetes.
English: The place within the chosen area should be changed with each injection to reduce the risk of lipodystrophy (changes in the distribution of body fat) under the skin that can affect the amount of insulin absorbed.
Danish: Dette er for at nedsætte risikoen for lipodystrofi (ændringer i kroppens fedtfordeling) under huden, som kan have indvirkning på, hvor stor en del af Tresiba, der optages af kroppen.
English: What is Tresiba used for?
Danish: Hvad anvendes Tresiba til?
English: Tresiba is used to treat type 1 and type 2 diabetes in adults and children aged 1 to 18 years of age.
Danish: Tresiba anvendes til behandling af voksne og børn i alderen 1-18 år med type 1- og type 2-diabetes (sukkersyge).
English: How has Tresiba been studied?
Danish: Hvordan blev Tresiba undersøgt?
English: It will also produce educational materials for patients on how to use Tresiba correctly, which they should receive through their doctor together with suitable training.
Danish: Virksomheden skal desuden udlevere oplysningsmateriale til patienter om, hvordan de skal bruge Tresiba korrekt.
English: What benefit has Tresiba shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Tresiba?
English: How is Tresiba used?
Danish: Hvordan anvendes Tresiba?
English: How does Tresiba work?
Danish: Hvordan virker Tresiba?
English: EPAR summary for the public irbesartan
Danish: EPAR sammendrag for offentligheden irbesartan
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sabervel on 13 April 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sabervel den 13. april 2012.
English: The full EPAR for Sabervel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Sabervel findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Sabervel
Danish: Andre oplysninger om Sabervel
English: The usual recommended dose of Sabervel is 150 mg once a day.
Danish: Den normalt anbefalede dosis af Sabervel er 150 mg en gang dagligt.
English: This is a summary of the European public assessment report (EPAR) for Sabervel.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Sabervel.
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 Sabervel.
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 anvendelsesbetingelserne for Sabervel.
English: This means that Sabervel is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aprovel.
Danish: Det betyder, at Sabervel er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Aprovel.
English: For more information about treatment with Sabervel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Sabervel, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Sabervel is a ‘generic medicine'.
Danish: Sabervel er et ‘generisk lægemiddel'.
English: What are the benefits and risks of Sabervel?
Danish: Hvilken fordel og risiko er der forbundet med Sabervel?
English: Sabervel is a medicine that contains the active substance irbesartan.
Danish: Sabervel er et lægemiddel, der indeholder det aktive stof irbesartan.
English: The active substance in Sabervel, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Det aktive stof i Sabervel, irbesartan, er en ”angiotensin II-receptorantagonist”, hvilket betyder, at det blokerer virkningen af et hormon i kroppen kaldet angiotensin II.