FrancophonIA/ELRC3.0 huggingface dataset:
English: For practical information about using Levetiracetam Hospira, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Levetiracetam Hospira, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: When Levetiracetam Hospira is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Danish: Når Levetiracetam Hospira anvendes alene, er startdosis 250 mg to gange dagligt, som efter to uger øges til 500 mg to gange dagligt.
English: When Levetiracetam Hospira is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing 50 kg or more is 500 mg twice a day.
Danish: Når Levetiracetam Hospira anvendes som tillægsbehandling til et andet lægemiddel mod epilepsi, er startdosis til patienter, som er over 12 år og vejer over 50 kg, 500 mg to gange dagligt.
English: Levetiracetam Hospira is an anti-epileptic medicine that contains the active substance levetiracetam.
Danish: Levetiracetam Hospira er et lægemiddel mod epilepsi og indeholder det aktive stof levetiracetam.
English: Why is Levetiracetam Hospira approved?
Danish: Hvorfor blev Levetiracetam Hospira godkendt?
English: How has Levetiracetam Hospira been studied?
Danish: Hvordan blev Levetiracetam Hospira undersøgt?
English: How is Levetiracetam Hospira used?
Danish: Hvordan anvendes Levetiracetam Hospira?
English: How does Levetiracetam Hospira work?
Danish: Hvordan virker Levetiracetam Hospira?
English: The medicine is used in:
Danish: Dette lægemiddel anvendes hos:
English: Myalepta has been authorised under ‘exceptional circumstances'.
Danish: Myalepta er godkendt under "særlige omstændigheder".
English: However, the medicine does not restore fat tissue under the skin.
Danish: Lægemidlet genskaber dog ikke fedtvævet under huden.
English: Further information on Myalepta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Myalepta findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It also results in insulin resistance (when the body is unable to recognise insulin, a hormone that helps regulate blood sugar levels).
Danish: Det medfører også insulinresistens (hvor kroppen ikke er i stand til at genkende insulin, der er et hormon, som hjælper med at regulere blodsukkerniveauet).
English: The recommended daily dose depends on the patient's bodyweight and is adjusted based on the patient's response to treatment.
Danish: Den anbefalede daglige dosis afhænger af patientens legemsvægt og tilpasses ud fra patientens respons på behandlingen.
English: In the studies Myalepta was not compared with any other treatment.
Danish: I studierne blev Myalepta ikke sammenlignet med nogen anden behandling.
English: As for all medicines, data on the use of Myalepta are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Myalepta løbende overvåget.
English: Because the number of patients with the various forms of lipodystrophy is low, the diseases are considered ‘rare', and Myalepta was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 July 2012.
Danish: Da antallet af patienter med de forskellige former for lipodystrofi er lavt, betragtes sygdommene som "sjældne", og Myalepta blev udpeget som "lægemiddel til sjældne sygdomme" den 17. juli 2012.
English: After 12 months of treatment, blood levels of fats (triglycerides) decreased from around 15 mmol/l to around 5 mmol/l in patients with generalised disease, and from around 16 mmol/l to around 6 mmol/l in patients with partial disease.
Danish: Efter 12 måneders behandling faldt niveauet af fedtstoffer i blodet (triglycerider) fra ca. 15 mmol/l til ca. 5 mmol/l hos patienter med generaliseret sygdom og fra ca. 16 mmol/l til ca. 6 mmol/l hos patienter med partiel sygdom.
English: Insulin resistance was also improved: blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, fell from 8.6% to 6.4% in patients with generalised lipodystrophy, and from 8.8% to 8.0% in patients with partial lipodystrophy.
Danish: Insulinresistens blev også forbedret: Blodniveauet af et stof kaldet glykosyleret hæmoglobin (HbA1c), der indikerer, hvor godt blodsukkeret er kontrolleret, faldt fra 8,6 % til 6,4 % hos patienter med generaliseret lipodystrofi og fra 8,8 % til 8,0 % hos patienter med partiel lipodystrofi.
English: Patients or carers can inject the medicine themselves once they have been trained.
Danish: Patienten selv eller en omsorgsperson kan indsprøjte lægemidlet efter forudgående oplæring.
English: The European Medicines Agency therefore decided that Myalepta's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Myalepta opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Myalepta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Myalepta?
English: Other information about Myalepta
Danish: Andre oplysninger om Myalepta
English: For more information about using Myalepta, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Myalepta, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: An overview of Myalepta and why it is authorised in the EU
Danish: En oversigt over Myalepta, og hvorfor det er godkendt i EU
English: Myalepta contains the active substance metreleptin.
Danish: Myalepta indeholder det aktive stof metreleptin.
English: Why is Myalepta authorised in the EU?
Danish: Hvorfor er Myalepta godkendt i EU?
English: Patients with lipodystrophy have low levels of a human hormone called leptin, which plays a key role in regulating the break-down of fats and sugars in the body.
Danish: Patienter med lipodystrofi har et lavt niveau af det humane hormon leptin, som spiller en vigtig rolle i reguleringen af nedbrydningen af fedt- og sukkerstoffer i kroppen.
English: Side effects reported with Myalepta are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Myalepta vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: What is Myalepta and what is it used for?
Danish: Hvad er Myalepta, og hvad anvendes det til?
English: • adults and children above the age of 2 years with generalised (throughout the body) lipodystrophy (Berardinelli-Seip syndrome and Lawrence syndrome);
Danish: • voksne og børn i alderen 2 år og opefter med generaliseret lipodystrofi (Berardinelli-Seip-syndrom og Lawrence-syndrom)
English: Side effects seen with Myalepta are of the kind expected from this type of treatment.
Danish: De bivirkninger, der ses ved Myalepta, er forventelige ved denne type behandling.
English: It replaces leptin and increases fat breakdown in the blood, muscles and liver, thereby correcting some abnormalities in patients with lipodystrophy, including insulin resistance.
Danish: Det erstatter leptin og øger nedbrydningen af fedt i blodet, musklerne og leveren, og dermed afhjælper det en række unormale forhold hos patienter med lipodystrofi, herunder insulinresistens.
English: Myalepta is given as a daily injection under the skin of the abdomen (belly), thigh or upper arm, at the same time every day.
Danish: Myalepta gives som en daglig injektion under huden på maven, låret eller overarmen på samme tidspunkt hver dag.
English: The active substance in Myalepta, metreleptin, is similar to leptin.
Danish: Det aktive stof i Myalepta, metreleptin, ligner leptin.
English: The most common side effects with Myalepta (which may affect more than 1 in 10 people) are hypoglycaemia (low blood glucose) and weight loss.
Danish: De hyppigste bivirkninger ved Myalepta (som kan forekomme hos mere end 1 ud af 10 patienter) er for lavt blodsukker og vægttab.
English: Since Myalepta has been authorised under exceptional circumstances, the company that markets Myalepta will set-up a registry of patients treated the medicine, and conduct studies to further investigate the benefits and risks of treatment including the possibility for Myalepta to trigger the production of antibodies.
Danish: Da Myalepta er godkendt under særlige omstændigheder, skal den virksomhed, der markedsfører Myalepta, oprette et register over patienter, der behandles med lægemidlet, og gennemføre studier med henblik på yderligere undersøgelse af fordele og risici ved behandlingen, herunder muligheden for, at Myalepta medfører dannelse af antistoffer.
English: What are the risks associated with Myalepta?
Danish: Hvilke risici er der forbundet med Myalepta?
English: Myalepta can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the diagnosis and management of patients with metabolic disorders.
Danish: Myalepta udleveres kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i diagnosticering og behandling af patienter med stofskiftesygdomme.
English: This leads to loss of fat from under the skin and its build-up in places such as the liver and muscles, as well as high levels of fat in the blood.
Danish: Det fører til tab af fedt under huden og ophobning af fedtet andre steder, som f.eks. i leveren og musklerne, og høje fedtniveauer i blodet.
English: This is because it has not been possible to obtain complete information about Myalepta due to the rarity of the condition.
Danish: Det skyldes, at det grundet sygdommens sjældenhed ikke har været muligt at indhente fyldestgørende oplysninger om Myalepta.
English: Myalepta has been shown to correct some abnormalities caused by leptin deficiency in patients with lipodystrophy, a rare condition for which few treatments are available.
Danish: Det er påvist, at Myalepta kan afhjælpe en række unormale forhold, der er forårsaget af leptinmangel, hos patienter med lipodystrofi, som er en sjælden sygdom, mod hvilken der kun findes få behandlinger.
English: What information is still awaited for Myalepta?
Danish: Hvilke oplysninger afventes der stadig for Myalepta?
English: Myalepta is a medicine used in addition to diet to treat lipodystrophy, where patients have loss of fatty tissue under the skin and build-up of fat elsewhere in the body such as in the liver and muscles.
Danish: Myalepta er et lægemiddel, der anvendes i tillæg til kost til at behandle lipodystrofi, der er en tilstand, hvor patienterne taber fedtvæv under huden, og hvor fedt ophobes andre steder i kroppen, f.eks. i leveren og musklerne.
English: The company that markets Myalepta will provide educational materials to patients and doctors with detailed information on how to use the medicine and what to do in case of side effects, including allergic reactions, hypoglycaemia and serious infections.
Danish: Den virksomhed, der markedsfører Myalepta, skal udarbejde informationsmateriale til patienter og læger med detaljerede oplysninger om, hvordan lægemidlet skal anvendes, og hvad man skal gøre i tilfælde af bivirkninger, herunder allergiske reaktioner, for lavt blodsukker og alvorlige infektioner.
English: For the full list of side effects and restrictions with Myalepta, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Myalepta fremgår af indlægssedlen.
English: How does Myalepta work?
Danish: Hvordan virker Myalepta?
English: How is Myalepta used?
Danish: Hvordan anvendes Myalepta?
English: • adults and children above the age of 12 years with partial (localised) lipodystrophy (including Barraquer-Simons syndrome), when standard treatments have failed.
Danish: • voksne og børn i alderen 12 år og opefter med partiel (lokaliseret) lipodystrofi (herunder
English: Myalepta has been shown to be effective at lowering blood fat levels in 2 main studies involving a total of 107 adults and children with generalised or partial lipodystrophy.
Danish: Det er i 2 hovedstudier med deltagelse af i alt 107 voksne og børn med generaliseret eller partiel lipodystrofi påvist, at Myalepta er effektivt til at sænke niveauet af fedtstoffer i blodet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Myalepta 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 Myalepta.
English: What benefits of Myalepta have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Myalepta?
English: The full EPAR for Rivastigmine 1 A Pharma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Rivastigmine 1 A Pharma findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine 1 A Pharma on 11 December 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rivastigmin 1 A Pharmaden 11. december 2009.
English: Rivastigmine 1 A Pharma should be given twice a day, with morning and evening meals.
Danish: Rivastigmine 1 A Pharma skal gives to gange dagligt, sammen med morgen- og aftensmåltidet.
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 Rivastigmine 1 A Pharma.
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 Rivastigmin 1 A Pharma.
English: This is a summary of the European public assessment report (EPAR) for Rivastigmine 1 A Pharma.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rivastigmine 1 A Pharma.
English: This authorisation was based on the authorisation granted to Exelon in 1998 (‘informed consent').
Danish: Denne tilladelse byggede på den tilladelse, som blev udstedt for Rivastigmine 1 A Pharma i 1998 (‘informeret samtykke').
English: Overall, the most common side effects include nausea (feeling sick, seen in 38 patients in 100) and vomiting (seen in 23 patients in 100), particularly during the phase when the dose of Rivastigmine 1 A Pharma is being increased.
Danish: Som helhed er de mest almindelige bivirkninger kvalme (som optræder hos 38 ud af 100 patienter) og opkastning (som optræder hos 23 ud af 100 patienter), især i den fase, hvor Rivastigmine 1 A Pharma dosen øges.
English: For more information about treatment with Rivastigmine 1 A Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Rivastigmine 1 A Pharmais, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: An additional study in 27 patients was used to show that Rivastigmine 1 A Pharma capsules and oral solution produced similar levels of the active substance in the blood.
Danish: I endnu en undersøgelse hos 27 patienter blev det vist, at Rivastigmine 1 A Pharma-kapsler og oral opløsning giver samme indhold af aktivt stof i blodet.
English: Rivastigmine 1 A Pharma was more effective than placebo at controlling symptoms.
Danish: Rivastigmine 1 A Pharma var mere effektivt end placebo til at begrænse symptomerne.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Rivastigmine 1 A Pharma by the patient.
Danish: Behandling bør kun indledes, hvis patienten har en plejer, der regelmæssigt overvåger patientens indtagelse af Rivastigmine 1 A Pharma.
English: Treatment with Rivastigmine 1 A Pharma should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Danish: Behandlingen med Rivastigmine 1 A Pharma bør indledes og overvåges af en læge med erfaring i diagnosticering og behandling af Alzheimers sygdom eller demens hos patienter med Parkinsons sygdom.
English: Rivastigmine 1 A Pharma is a medicine containing the active substance rivastigmine.
Danish: Rivastigmine 1 A Pharma er et lægemiddel, der indeholder det aktive stof rivastigmin.
English: Rivastigmine 1 A Pharma is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Danish: Rivastigmine 1 A Pharma anvendes til behandling af patienter med let til middelsvær Alzheimers demens, en fremadskridende hjernesygdom, der gradvis angriber hukommelse, intellektuelle evner og adfærd.
English: Therefore, the Committee decided that Rivastigmine 1 A Pharma's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget var derfor af den opfattelse, at fordelene ved Rivastigmine 1 A Pharma opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Rivastigmine 1 A Pharma has been studied in three main studies involving 2,126 patients with mild to moderately severe Alzheimer's disease.
Danish: Rivastigmine 1 A Pharma blev undersøgt i tre hovedundersøgelser med 2 126 patienter med let til middelsvær Alzheimers sygdom.
English: Rivastigmine 1 A Pharma must not be used in people who are hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other ingredients.
Danish: Rivastigmine 1 A Pharma bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for rivastigmin, andre stoffer afledt af carbamat eller andre af indholdsstofferne.
English: Rivastigmine 1 A Pharma was also studied in 541 patients with dementia due to Parkinson's disease.
Danish: Rivastigmine 1 A Pharma blev desuden undersøgt hos 541 patienter med demens som følge af Parkinsons sygdom.
English: Other information about Rivastigmine 1 A Pharma
Danish: Andre oplysninger om Rivastigmine 1 A Pharma
English: The active substance in Rivastigmine 1 A Pharma, rivastigmine, is an antidementia medicine.
Danish: Det aktive stof i Rivastigmine 1 A Pharma, rivastigmin, er et middel mod demens.
English: The patients with dementia due to Parkinson's disease taking Rivastigmine 1 A Pharma capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points.
Danish: Af de patienter, der havde demens som følge af Parkinsons sygdom, gav Rivastigmine 1 A Pharmakapsler en bedring i de kognitive symptomer på 2,1 points, sammenholdt med en forværring på 0,7 points hos dem, der fik placebo.
English: In the three studies of Rivastigmine 1 A Pharma in patients with Alzheimer's dementia, patients taking doses of Rivastigmine 1 A Pharma between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance.
Danish: Hos de patienter, der fik Rivastigmine 1 A Pharma, 6 til 9 mg dagligt, øgedes de kognitive symptomer med 0,2 points fra et udgangspunkt på 22,9 points ved undersøgelsens start (lavere score = bedre præstationer).
English: The global symptom score also improved more in the patients taking Rivastigmine 1 A Pharma.
Danish: Også i score vedrørende overordnede funktioner var der større bedring hos de patienter, der fik Rivastigmine 1 A Pharma.
English: The CHMP concluded that Rivastigmine 1 A Pharma has a modest effectiveness in treating the symptoms of Alzheimer's dementia, although this does reflect an important benefit in some patients.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at virkningen af Rivastigmine 1 A Pharma på symptomerne på Alzheimers sygdom er beskeden, men at den hos nogle patienter er vigtig.
English: For the full list of all side effects reported with Rivastigmine 1 A Pharma, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Rivastigmine 1 A Pharma fremgår af indlægssedlen.
English: All of the studies lasted six months and compared the effects of Rivastigmine 1 A Pharma with those of placebo (a dummy treatment).
Danish: I dem alle blev virkningerne af Rivastigmine 1 A Pharma sammenlignet med virkningerne af placebo (virkningsløs behandling).
English: Rivastigmine 1 A Pharma is also used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Danish: Rivastigmine 1 A Pharma kan desuden anvendes til behandling af let til middelsvær demens hos patienter med Parkinsons sygdom.
English: The types of side effects seen with Rivastigmine 1 A Pharma depend on the type of dementia it is being used to treat.
Danish: Bivirkningerne af Rivastigmine 1 A Pharma afhænger af den form for demens, patienten har.
English: What is the risk associated with Rivastigmine 1 A Pharma?
Danish: Hvilken risiko er der forbundet med Rivastigmine 1 A Pharma?
English: The Committee initially concluded that for the treatment of dementia due to Parkinson's disease, Rivastigmine 1 A Pharma's benefits did not outweigh its risks.
Danish: Udvalget konkluderede først, at fordelene ved Rivastigmine 1 A Pharma ikke opvejer risiciene til behandling af demens ved Parkinsons sygdom.
English: Why has Rivastigmine 1 A Pharma been approved?
Danish: Hvorfor blev Rivastigmine 1 A Pharma godkendt?
English: What is Rivastigmine 1 A Pharma?
Danish: Hvad er Rivastigmine 1 A Pharma?
English: How has Rivastigmine 1 A Pharma been studied?
Danish: Hvordan blev Rivastigmine 1 A Pharma undersøgt?
English: By blocking these enzymes, Rivastigmine 1 A Pharma allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia due to Parkinson's disease.
Danish: Ved at blokere disse enzymer øger Rivastigmine 1 A Pharma hjernens indhold af acetylcholin.
English: For the global score, patients taking Rivastigmine 1 A Pharma had an increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
Danish: For score vedrørende overordnede funktioner var der en stigning på 4,1 points hos patienterne på Rivastigmine 1 A Pharma.
English: What is Rivastigmine 1 A Pharma used for?
Danish: Hvad anvendes Rivastigmine 1 A Pharma til?
English: What benefit has Rivastigmine 1 A Pharma shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Rivastigmine 1 A Pharma?
English: How is Rivastigmine 1 A Pharma used?
Danish: Hvordan anvendes Rivastigmine 1 A Pharma?
English: Some of the areas harmonised include:
Danish: De harmoniserede områder omfatter bl.a.:
English: Vascace should be taken once a day at about the same time each day.
Danish: Vascace skal tages én gang daglig på cirka samme tidspunkt hver dag.
English: It must also not be used in the second and third trimesters (the last six months) of pregnancy.
Danish: Endvidere må det ikke anvendes under andet og tredje trimester (de sidste seks måneder) af graviditeten.
English: János Borvendég (Hungary)
Danish: János Borvendég (Ungarn)
English: What is Vascace?
Danish: Hvad er Vascace?
English: Vascace is authorised in the EU via national procedures.
Danish: Vascace er godkendt i EU efter nationale procedurer.
English: The company that markets these medicines is F. Hoffmann - La Roche Ltd.
Danish: Disse lægemidler markedsføres af virksomheden F. Hoffmann - La Roche Ltd.