FrancophonIA/ELRC3.0 huggingface dataset:
English: • moderate to severe restless legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Danish: • Moderat til svær grad af uro i benene (Restless Legs Syndrome - RLS), som er en lidelse, hvor patienten har en uimodståelig trang til at bevæge lemmerne for at standse ubehagelige, smertefulde eller underlige fornemmelser i kroppen, sædvanligvis om natten.
English: Leganto must not be used in people who are hypersensitive (allergic) to rotigotine or any of the other ingredients.
Danish: Leganto må ikke anvendes af patienter, der er overfølsomme (allergiske) over for rotigotin eller andre af indholdsstofferne.
English: The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be improved by rotigotine.
Danish: Syndromet menes at skyldes problemer med den måde, hvorpå dopamin virker i hjernen, hvilket rotigotin kan rette op på.
English: Leganto is used on its own in early-stage disease, or in combination with levodopa (another medicine used in Parkinson's disease) at any stage of the disease, including the later stages when levodopa starts becoming less effective;
Danish: Leganto anvendes alene i et tidligt stadium af sygdommen eller i kombination med levodopa (et andet lægemiddel, som anvendes ved Parkinsons sygdom) på ethvert sygdomsstadium, herunder de senere stadier, når levodopa begynder af have mindre effekt.
English: In smaller studies completed later, the effectiveness of Leganto was found to be comparable with ropinirole.
Danish: I de mindre undersøgelser, der senere blev gennemført, blev virkningen af Leganto påvist at være sammenlignelig med ropinirol.
English: Two of these studies also compared Leganto with other dopamine agonists (ropinirole in early-stage disease and pramipexole in advanced disease).
Danish: I to af disse undersøgelser blev Leganto også sammenlignet med andre dopaminagonister (ropinirol i det tidlige sygdomsstadium og pramipexol i det fremskredne sygdomsstadium).
English: The studies in early-stage disease looked at the number of patients who had at least a 20% improvement in symptoms, as measured with a standard symptom questionnaire.
Danish: I undersøgelserne af sygdommen i det tidlige stadium blev der set på antallet af patienter, som havde en forbedring af symptomerne på mindst 20 % målt med et standardspørgeskema for disse symptomer.
English: What is the risk associated with Leganto?
Danish: Hvilken risiko er der forbundet med Leganto?
English: The patch is applied to dry, clean, healthy skin on the abdomen (tummy), thigh, hip, side, shoulder or upper arm.
Danish: Plasteret sættes på tør, ren, sund hud på maven, låret, hoften, siden, skulderen eller overarmen.
English: In early-stage disease, 48 to 52% of the patients using Leganto had an improvement in symptoms, compared with 19 to 30% of those using placebo.
Danish: I det tidlige stadium oplevede 48 til 52 % af de patienter, der fik Leganto, en forbedring af symptomerne sammenlignet med 19 til 30 % af dem, som fik placebo.
English: The decrease seen with Leganto was similar to that seen with pramipexole (2.8 h).
Danish: Faldet, som kunne iagttages med Leganto, svarede til det, der sås med pramipexol (2,8 t).
English: The most common side effects with Leganto in patients with Parkinson's disease (seen in more than 1 patient in 10) are somnolence (sleepiness), dizziness, headache, nausea (feeling sick), vomiting, and application site reactions such as redness, itching and irritation of the skin.
Danish: De hyppigste bivirkninger ved Leganto hos patienter med Parkinsons sygdom (som optræder hos flere end 1 ud af 10 patienter) er søvntrang, svimmelhed, hovedpine, kvalme, opkastninger og reaktioner på påføringsstedet såsom rødme, kløe og irritation af huden.
English: In advanced Parkinson's disease, patients using Leganto had a greater decrease in their ‘off' time than those taking placebo (a decrease of 2.1 to 2.7 h with Leganto compared with 0.9 h with placebo).
Danish: Ved fremskreden Parkinsons sygdom havde patienter, som fik Leganto, et større fald i deres "slået fra"-tid end dem, der fik placebo (et fald på 2,1 til 2,7 t med Leganto sammenlignet med 0,9 t med placebo).
English: In Parkinson's disease, Leganto has been compared with placebo (a dummy treatment) in four studies involving 830 patients with early-stage disease and 842 patients with advanced disease.
Danish: Til Parkinsons sygdom blev Leganto sammenlignet med placebo (en virkningsløs behandling) i fire undersøgelser, som omfattede 830 patienter med sygdommen i et tidligt stadium og 842 patienter med sygdommen i et fremskredent stadium.
English: Why has Leganto been approved?
Danish: Hvorfor blev Leganto godkendt?
English: For restless legs syndrome, the maximum dose is 3 mg/24 h.
Danish: Til RLS er den maksimale dosis 3 mg/24 t.
English: In moderate to severe restless legs syndrome, Leganto has been compared with placebo in two main studies involving a total of 963 patients.
Danish: Til moderat til svær RLS blev Leganto sammenlignet med placebo i to hovedundersøgelser, som omfattede i alt 963 patienter.
English: In patients with restless legs syndrome, the most common side effects (seen in more than 1 patient in 10) are nausea, application site reactions, asthenic conditions (conditions such as tiredness, weakness and feeling unwell) and headache.
Danish: Hos patienter med RLS er de hyppigste bivirkninger (som optræder hos flere end 1 ud af 10 patienter) kvalme, reaktioner på påføringsstedet, slaphedstilstande (tilstande såsom træthed, svaghed og utilpashed) og hovedpine.
English: For the full list of all side effects reported with Leganto, see the package leaflet.
Danish: Den fuldstændige liste over alle indberettede bivirkninger ved Leganto fremgår af indlægssedlen.
English: What is Leganto?
Danish: Hvad er Leganto?
English: In restless legs syndrome, patients using doses of Leganto between 1 and 3 mg/24 h had a greater improvement than those using placebo in the two studies, as measured on both symptom scales.
Danish: Til RLS havde patienter, som fik doser af Leganto på mellem 1 og 3 mg/24 t, en større forbedring end dem, der fik placebo, i de to undersøgelser målt på begge symptomskalaer.
English: What is Leganto used for?
Danish: Hvad anvendes Leganto til?
English: How has Leganto been studied?
Danish: Hvordan blev Leganto undersøgt?
English: Two smaller studies comparing Leganto with ropinirole were completed after the medicine's authorisation.
Danish: Leganto blev sammenlignet med ropinirol i to mindre undersøgelser, der blev gennemført efter lægemidlets godkendelse.
English: How is Leganto used?
Danish: Hvordan anvendes Leganto?
English: What benefit has Leganto shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Leganto?
English: How does Leganto work?
Danish: Hvordan virker Leganto?
English: The way rotigotine works in restless legs syndrome is not fully understood.
Danish: Det vides endnu ikke med nøjagtighed, hvordan rotigotin virker ved RLS.
English: Other information about Spectrila
Danish: Andre oplysninger om Spectrila
English: This is a summary of the European public assessment report (EPAR) for Spectrila.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Spectrila.
English: The full EPAR and risk management plan summary for Spectrila can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Spectrila findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Spectrila is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Spectrila anvendes så sikkert som muligt.
English: The healthcare professional should only give the medicine in a hospital setting where resuscitation equipment is available.
Danish: Sundhedspersonerne bør kun give lægemidlet på et hospital, hvor der er genoplivningsudstyr til rådighed.
English: Only healthcare professionals experienced in cancer treatments should prescribe and give Spectrila.
Danish: Kun sundhedspersoner med erfaring i kræftbehandling bør ordinere og give Spectrila.
English: Normal cells, by contrast, can produce their own asparagine and are less affected by the medicine.
Danish: Normale celler kan derimod producere deres eget asparagin og påvirkes mindre af lægemidlet.
English: What measures are being taken to ensure the safe and effective use of Spectrila?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Spectrila?
English: Why is Spectrila approved?
Danish: Hvorfor blev Spectrila godkendt?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that the benefits of Spectrila are greater than the risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Spectrila opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What is Spectrila and what is it used for?
Danish: Hvad er Spectrila, og hvad anvendes det til?
English: Although the data in adults are limited, there is substantial clinical experience of asparaginase medicines in adults, and the benefits of Spectrila in adults can be expected to be similar.
Danish: Data hos voksne er begrænsede, men der er solid klinisk erfaring med asparaginase hos voksne, og fordelene ved Spectrila til voksne kan forventes at være tilsvarende.
English: In a study in 199 children with ALL, Spectrila was as effective as another asparaginase medicine (both used in combination with other medicines) in reducing blood asparagine: 95% of patients treated with Spectrila and 94% of those treated with the other medicine containing asparaginase had complete depletion (reduction) of blood asparagine.
Danish: I en undersøgelse hos 199 børn med ALL var Spectrila lige så effektivt som et andet lægemiddel indeholdende asparaginase (begge anvendt i kombination med andre lægemidler) til at nedsætte blodets indhold af asparagin: 95 % af de patienter, der blev behandlet med Spectrila, og 94 % af dem, der blev behandlet med et andet lægemiddel indeholdende asparaginase, fik fuldstændig fjernet blodets indhold af asparagin.
English: It is not intended to provide practical advice on how to use Spectrila.
Danish: Det er ikke en praktisk vejledning i, hvordan Spectrila bør anvendes.
English: Spectrila is given every 3 days by infusion (drip) into a vein, with the dose depending on the patient's age and body surface area.
Danish: Spectrila gives hver 3. dag med drop (ved infusion) i en vene, idet dosis afhænger af patientens alder og legemsoverflade.
English: What are the risks associated with Spectrila?
Danish: Hvilke risici er der forbundet med Spectrila?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom multiply, and so its reduction in the blood causes the cells to die.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Spectrila, 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 Spectrila, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Spectrila is effective at reducing blood asparagine that the cancer cells need to survive.
Danish: Spectrila er effektivt til at nedsætte blodets indhold af asparagin, som kræftcellerne behøver for at overleve.
English: The most common side effects with Spectrila (which may affect more than 1 in 10 people) are allergic reactions (including flushing, rash, low blood pressure, hives and difficulty breathing), diarrhoea, nausea, vomiting, abdominal pain, tiredness, swelling (caused by fluid build-up), high blood sugar, and low blood levels of albumin (a protein) and other abnormalities in blood tests.
Danish: De hyppigste bivirkninger ved Spectrila (som kan forekomme hos mere end 1 ud af 10 personer), er allergiske reaktioner (herunder rødme, udslæt, lavt blodtryk, nældefeber og vejrtrækningsbesvær), diarré, kvalme, opkastning, mavesmerter, træthed, hævelse (forårsaget af væskeophobning), højt blodsukker og lavt indhold af proteinet albumin i blodet samt andre unormale blodprøver.
English: For more information about treatment with Spectrila, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Spectrila, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: As for its risks, the side effects of Spectrila are similar to those of other asparaginase medicines and are addressed in the medicine's risk minimisation plan.
Danish: Hvad angår risici, svarer bivirkningerne ved Spectrila til bivirkningerne af andre asparaginaselægemidler og er omfattet af risikominimeringsplanen for lægemidlet.
English: It must also not be used in patients who have ever had pancreatitis, or severe bleeding or blood clots following asparaginase treatment.
Danish: Det må heller ikke anvendes hos patienter, der har haft bugspytkirtelbetændelse, svære blødninger eller blodpropper efter behandling med asparaginase.
English: For the full list of side effects reported with Spectrila, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Spectrila fremgår af indlægssedlen.
English: The active substance in Spectrila, asparaginase, is an enzyme that works by breaking up and reducing the blood levels of the amino acid asparagine.
Danish: Det aktive stof i Spectrila, asparaginase, indeholder et enzym, der virker ved at nedbryde aminosyren asparagin i blodet og derved nedsætte dens koncentration.
English: For practical information about using Spectrila, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Spectrila, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The most serious side effects with Spectrila include severe allergic reactions, blood clots, pancreatitis (inflammation of the pancreas), and liver problems.
Danish: De alvorligste bivirkninger ved Spectrila er svære allergiske reaktioner, blodpropper, bugspytkirtelbetændelse (pankreatitis) og leverproblemer.
English: What benefits of Spectrila have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Spectrila?
English: Spectrila can only be obtained with a prescription and is available in a vial as a powder to be made into a solution for infusion.
Danish: Spectrila udleveres kun efter recept og fås i hætteglas som et pulver, hvoraf der fremstilles en infusionsvæske.
English: How is Spectrila used?
Danish: Hvordan anvendes Spectrila?
English: Spectrila must not be used in patients who are allergic to any asparaginase preparation and those who have pancreatitis (inflammation of the pancreas), severe liver disease or blood clotting problems.
Danish: Spectrila må ikke anvendes hos patienter, der er allergiske over for noget lægemiddel indeholdende asparaginase eller hos dem, der har haft bugspytkirtelbetændelse (pankreatitis), svær leversygdom eller blodpropper.
English: How does Spectrila work?
Danish: Hvordan virker Spectrila?
English: Spectrila is used in adults and children to treat acute lymphoblastic leukaemia (ALL), a cancer of white blood cells called lymphoblasts, in combination with other cancer medicines.
Danish: Spectrila er et lægemiddel til behandling af akut lymfoblastær leukæmi, en kræftform udgående fra de hvide blodlegemer, der kaldes lymfoblaster.
English: The cancer cells need this amino acid to grow and
Danish: Kræftcellerne behøver denne aminosyre for at vokse og formere sig, hvorfor nedsættelse af dens koncentration i blodet får kræftcellerne til at dø.
English: It contains the active substance asparaginase.
Danish: Det indeholder det aktive stof asparaginase og anvendes i kombination med andre lægemidler mod kræft.
English: EU Numbers
Danish: EU-nummer
English: Strength Pharmaceutical Form Route of administration Packaging
Danish: Lægemiddelform Indgivelsesvej
English: • Encouragement to report medications errors and their causes and consequences.
Danish: • Opfordring til rapportering af fejlmedicinering samt årsager og konsekvenser.
English: The Marketing Authorisation Holder must implement this educational plan nationally, prior to marketing, and as agreed with the competent authorities in the Member States.
Danish: Indehaveren af markedsføringstilladelsen skal implementere denne uddannelsesplan nationalt, før markedsføring, og i overensstemmelse med de pågældende myndigheder i medlemslandene.
English: • Clear information about their difference in concentration.
Danish: • Tydelig information om koncentrationsforskellene
English: The patient information pack to be used by healthcare professionals in the education of the patients should contain the same above described key elements.
Danish: Informationspakken til patienter, som skal anvendes af sundhedspersonale i uddannelsen af patienterne, bør indeholde de samme nøgleelementer, som beskrevet ovenfor.
English: Both information packs are to be used as part of an educational plan provided to minimise risk of medication errors that may be associated with the change in concentration of the new Novoseven formulation.
Danish: Begge informationspakker skal bruges som led i et uddannelsesforløb, der skal sikre, at risikoen for fejlmedicinering, der kan være associeret med ændringen i koncentration af den nye formulering af NovoSeven, mindskes.
English: • Information about the potential safety risks of errors in dosing calculation resulting from the confusion between the two formulations and its possible clinical consequences (e.g. potential for thrombotic risk if overdose).
Danish: • Information om de potentielle sikkerhedsrisici ved fejlberegning af dosering, som følge af forveksling af de to formuleringer og de mulige kliniske konsekvenser heraf (f.eks. potentiel risiko for tromboser ved overdosering)
English: The physician information should contain the following key elements:
Danish: Lægeinformationen skal indeholde følgende nøgleelementer:
English: • Summary leaflet of the product features and reconstitution guide, including highlighted changes that have been made for the new formulation of NovoSeven.
Danish: • Opsummerende folder indeholdende produktkarakteristika og rekonstitutionsvejledning inklusive fremhævede ændringer, der er foretaget i den nye fomulering af NovoSeven
English: • Letter to healthcare professionals
Danish: • Brev til sundhedspersonale.
English: • Clear demarcation of the new formulation of NovoSeven from original NovoSeven, with clear descriptions of any differences in the vial sizes, colour codes and dosing and reconstitution instructions
Danish: • Tydelig afgrænsning af den nye formulering i forhold til den oprindelige formulering af NovoSeven med tydelige beskrivelser af alle forskelle i størrelser på hætteglas, farvekoder og dosering samt rekonstitutionsvejledning
English: The Marketing Authorisation Holder (MAH) shall ensure that, at launch, all physicians who are expected to prescribe/use NovoSeven are provided with an Educational pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal ved lancering sikre, at læger, som forventes at skulle udskrive/bruge NovoSeven, er blevet forsynet med en træningspakke, der indeholder følgende:
English: The Member States shall ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemslandene skal sikre, at alle betingelser eller restriktioner hvad, angår sikker og effektiv brug af lægemidlet beskrevet nedenfor, bliver implementeret:
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET DER SKAL IMPLEMENTERES AF MEDLEMSLANDENE
English: • Dosing reference card
Danish: • Doseringskort
English: The physician information pack should contain the following:
Danish: Informationspakken til læger skal indeholde følgende:
English: • Physician information pack
Danish: • Informationspakke til læger
English: • Question & Answer booklet
Danish: • Pjece med spørgsmål og svar
English: Elimination Following oral administration of [
Danish: Elimination Efter oral administration af [
English: Elderly (≥ 65 years)
Danish: Ældre patienter (≥ 65 år)
English: - if you have liver problems.
Danish: - hvis du har leverproblemer.
English: The absolute bioavailability is 85%.
Danish: Den absolutte biotilgængelighed er 85 %.
English: Please also see information about this in section “Warnings and precautions”.
Danish: Se også information omkring dette i afsnittet ”Advarsler og forsigtighedsregler”.
English: Medical attention may be necessary.
Danish: Lægebehandling kan være nødvendig.
English: Date of first authorisation: 01 December 2008 Date of latest renewal: 31 July 2013
Danish: Dato for første markedsføringstilladelse: 01. december 2008 Dato for seneste fornyelse: 31. juli 2013
English: These changes are not considered to be clinically relevant, however.
Danish: Disse ændringer betragtes dog ikke som klinisk relevante.
English: - if you drink alcohol excessively (whether every day or only from time to time).
Danish: - hvis du drikker for meget alkohol (uanset om det er hver dag eller kun engang imellem).
English: However, this has not been established in the target population.
Danish: Dette er dog ikke fastslået hos målpopulationen.
English: The clinical relevance of this decrease is unknown.
Danish: Den kliniske relevans af denne reduktion er ukendt.
English: • Risk Management Plan (RMP)
Danish: • Risokostyringsplan (RMP)
English: Combinations not recommended
Danish: Kombination anbefales ikke
English: Do not take a double dose (two tablets at once) to make up for a forgotten tablet.
Danish: Du må ikke tage en dobbeltdosis (to tabletter på én gang) som erstatning for den glemte tablet.
English: PA/Alu/PVC/Alu 2 years PCTFE/PVC/Alu 18 months
Danish: PA/Alu/PVC/Alu 2 år PCTFE/PVC/Alu 18 måneder
English: The mean volume of distribution (Vd) ranged between 63-276 litres.
Danish: Det gennemsnitlige fordelingsvolumen (Vd) varierede mellem 63-276 liter.
English: An updated RMP shall be submitted every three years.
Danish: En opdateret RMP skal fremsendes hvert 3. år.
English: Supportive management is recommended.
Danish: Der anbefales støttende behandling.
English: These were consistently located on the extremities (hands, feet, ears and tail).
Danish: De var konsekvent lokaliseret på ekstremiteterne (hænder, fødder, ører og hale).
English: Do not stop taking Zomarist unless your doctor tells you to.
Danish: Hold ikke op med at tage Zomarist, medmindre lægen siger det.
English: Zomarist should not be used during pregnancy.
Danish: Zomarist bør ikke anvendes under graviditen.
English: However, the magnitude of change is not clinically significant, so that vildagliptin can be given with or without food.
Danish: Ændringens størrelse er dog ikke klinisk signifikant, så vildagliptin kan gives med eller uden mad.
English: - if you have a severe infection or are seriously dehydrated (have lost a lot of water from your body).
Danish: - hvis du har en svær infektion eller er alvorligt dehydreret (har mistet en masse vand fra kroppen).
English: A slow increase in the dose may also improve gastrointestinal tolerability.
Danish: En langsom stigning i dosis kan også forbedre den gastrointestinale tolerabilitet.
English: A pre- and postnatal development study was performed in rats.
Danish: Der blev udført et præ- og postnatalt udviklingsstudie på rotter.