FrancophonIA/ELRC3.0 huggingface dataset:
English: Neupro must not be used in people who are hypersensitive (allergic) to rotigotine or any of the other ingredients.
Danish: Neupro må ikke anvendes af patienter, der er overfølsomme (allergiske) over for rotigotin eller andre af indholdsstofferne.
English: Neupro 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: Neupro 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: Two of these studies also compared Neupro with other dopamine agonists (ropinirole in early-stage disease and pramipexole in advanced disease).
Danish: I to af disse undersøgelser blev Neupro også sammenlignet med andre dopaminagonister (ropinirol i det tidlige sygdomsstadium og pramipexol i det fremskredne sygdomsstadium).
English: The decrease seen with Neupro was similar to that seen with pramipexole (2.8 h).
Danish: Faldet, som kunne iagttages med Neupro, svarede til det, der sås med pramipexol (2,8 t).
English: What is the risk associated with Neupro?
Danish: Hvilken risiko er der forbundet med Neupro?
English: The most common side effects with Neupro 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 Neupro 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 Neupro had a greater decrease in their ‘off' time than those taking placebo (a decrease of 2.1 to 2.7 h with Neupro compared with 0.9 h with placebo).
Danish: Ved fremskreden Parkinsons sygdom havde patienter, som fik Neupro, et større fald i deres "slået fra"tid end dem, der fik placebo (et fald på 2,1 til 2,7 t med Neupro sammenlignet med 0,9 t med placebo).
English: In early-stage disease, 48 to 52% of the patients using Neupro 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 Neupro, en forbedring af symptomerne sammenlignet med 19 til 30 % af dem, som fik placebo.
English: In Parkinson's disease, Neupro 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 Neupro 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: For the full list of all side effects reported with Neupro, see the package leaflet.
Danish: Den fuldstændige liste over alle indberettede bivirkninger ved Neupro fremgår af indlægssedlen.
English: Why has Neupro been approved?
Danish: Hvorfor blev Neupro godkendt?
English: In moderate to severe restless legs syndrome, Neupro has been compared with placebo in two main studies involving a total of 963 patients.
Danish: Til moderat til svær RLS blev Neupro sammenlignet med placebo i to hovedundersøgelser, som omfattede i alt 963 patienter.
English: In restless legs syndrome, patients using doses of Neupro 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 Neupro 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 Neupro?
Danish: Hvad er Neupro?
English: What benefit has Neupro shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Neupro?
English: How has Neupro been studied?
Danish: Hvordan blev Neupro undersøgt?
English: What is Neupro used for?
Danish: Hvad anvendes Neupro til?
English: Two smaller studies comparing Neupro with ropinirole were completed after the medicine's authorisation.
Danish: Neupro blev sammenlignet med ropinirol i to mindre undersøgelser, der blev gennemført efter lægemidlets godkendelse.
English: How is Neupro used?
Danish: Hvordan anvendes Neupro?
English: How does Neupro work?
Danish: Hvordan virker Neupro?
English: The full EPAR for Zoledronic acid Teva 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 Zoledronic acid Teva Pharma findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is used in patients who are at risk of fractures (broken bones), including those who have recently broken their hip in a minor trauma such as a fall, and in patients whose osteoporosis is linked to long-term treatment with glucocorticoids (a type of steroid).
Danish: Det anvendes til patienter, som har risiko for knoglebrud eller som for nyligt har brækket hoften ved et mindre traume som f.eks. et fald, og til patienter, hvis osteoporose hænger sammen med en langsigtet behandling med glucocorticoider (en form for steroid).
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 Zoledronic acid Teva 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 Zoledronic acid Teva Pharma.
English: Using paracetamol or ibuprofen (anti-inflammatory medicines) shortly after Zoledronic acid Teva Pharma can reduce symptoms such as fever, muscle pain, influenza (flu)-like symptoms, joint pain and headache in the three days following the infusion.
Danish: Anvendelse af paracetamol eller ibuprofen (antiinflammatoriske lægemidler) kort tid efter Zoledronic acid Teva Pharma kan lindre symptomer såsom feber, muskelsmerter, influenzalignende symptomer, ledsmerter og hovedpine i de tre dage efter infusionen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Teva Pharma on 16 August 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zoledronic acid Teva Pharma den 16. august 2012.
English: Therefore, the CHMP's view was that, as for Aclasta, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Aclasta.
English: This means that Zoledronic acid Teva Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aclasta.
Danish: Det betyder, at Zoledronic acid Teva Pharma er identisk med et ”referencelægemiddel”, som allerede er godkendt i Den Europæiske Union (EU), og som hedder Aclasta.
English: For Paget's disease, only one infusion of Zoledronic acid Teva Pharma is usually given, but additional infusions can be considered if the patient's disease comes back.
Danish: Ved Pagets sygdom gives der almindeligvis kun en infusion af Zoledronic acid Teva Pharma, men yderligere infusioner kan overvejes, hvis patientens sygdom kommer tilbage.
English: For more information about treatment with Zoledronic acid Teva 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 Zoledronic acid Teva Pharma, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: No additional studies were needed as Zoledronic acid Teva Pharma is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Aclasta.
Danish: Der krævedes ingen supplerende undersøgelser, da Zoledronic acid Teva Pharma er et generisk lægemiddel, der gives ved infusion og indeholder det samme aktive stof som referencelægemidlet Aclasta.
English: A risk management plan has been developed to ensure that Zoledronic acid Teva Pharma is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Zoledronic acid Teva Pharma anvendes så sikkert som muligt.
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Teva Pharma has been shown to be comparable to Aclasta.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Zoledronic acid Teva Pharma er sammenlignelig med Aclasta.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Teva Pharma.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zoledronic acid Teva Pharma.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Teva Pharma, 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 Zoledronic acid Teva Pharma, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Patients who have broken their hip should not receive Zoledronic acid Teva Pharma any earlier than two weeks after the operation to repair the fracture.
Danish: Patienter, som har brækket hoften, bør først få Zoledronic acid Teva Pharma to uger efter operationen, hvor bruddet blev repareret.
English: Zoledronic acid Teva Pharma is given as an infusion lasting at least 15 minutes.
Danish: Zoledronic acid Teva Pharma gives som en infusion, der varer mindst 15 minutter.
English: Zoledronic acid Teva Pharma is a solution for infusion (drip) into a vein that contains the active substance zoledronic acid (5 mg).
Danish: Zoledronic acid Teva Pharma er en opløsning til infusion (drop) i en vene, der indeholder det aktive stof zoledronsyre (5 mg).
English: In the treatment of Paget's disease of the bone, Zoledronic acid Teva Pharma must only be used by a doctor who has experience in the treatment of the disease.
Danish: Ved behandling af Pagets sygdom må Zoledronic acid Teva Pharma kun gives af en læge med erfaring i behandling af sygdommen.
English: Because Zoledronic acid Teva Pharma is a generic, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Zoledronic acid Teva Pharma er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Zoledronic acid Teva Pharma should not be used in patients with severe kidney problems.
Danish: Zoledronic acid Teva Pharma bør ikke anvendes til patienter, som har svære nyreproblemer.
English: The active substance in Zoledronic acid Teva Pharma, zoledronic acid, is a bisphosphonate.
Danish: Det aktive stof i Zoledronic acid Teva Pharma, zoledronsyre, er et bisphosphonat.
English: Zoledronic acid Teva Pharma is also used to treat Paget's disease of the bone in adults.
Danish: Zoledronic acid Teva Pharma anvendes også til at behandle Pagets knoglesygdom hos voksne.
English: Zoledronic acid Teva Pharma is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men.
Danish: Zoledronic acid Teva Pharma anvendes til behandling af osteoporose (en sygdom, der gør knoglerne skøre) hos kvinder, der har været gennem overgangsalderen, og hos mænd.
English: What measures are being taken to ensure the safe and effective use of Zoledronic acid Teva Pharma?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zoledronic acid Teva Pharma?
English: Zoledronic acid Teva Pharma zoledronic acid
Danish: Zoledronic acid Teva Pharma zoledronsyre
English: Other information about Zoledronic acid Teva Pharma
Danish: Andre oplysninger om Zoledronic acid Teva Pharma
English: What are the benefits and risks of Zoledronic acid Teva Pharma?
Danish: Hvilke fordele og risici er der forbundet med Zoledronic acid Teva Pharma?
English: Zoledronic acid Teva Pharma is a ‘generic medicine'.
Danish: Zoledronic acid Teva Pharma er et ”generisk lægemiddel”.
English: The Committee recommended that Zoledronic acid Teva Pharma be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Zoledronic acid Teva Pharma.
English: Why has Zoledronic acid Teva Pharma been approved?
Danish: Hvorfor blev Zoledronic acid Teva Pharma godkendt?
English: What is Zoledronic acid Teva Pharma?
Danish: Hvad er Zoledronic acid Teva Pharma?
English: How has Zoledronic acid Teva Pharma been studied?
Danish: Hvordan blev Zoledronic acid Teva Pharma undersøgt?
English: How is Zoledronic acid Teva Pharma used?
Danish: Hvordan anvendes Zoledronic acid Teva Pharma?
English: How does Zoledronic acid Teva Pharma work?
Danish: Hvordan virker Zoledronic acid Teva Pharma?
English: What is Zoledronic acid Teva Pharma used for?
Danish: Hvad anvendes Zoledronic acid Teva Pharma til?
English: This is to be expected and you should not be concerned
Danish: Det er forventeligt, og du skal ikke været bekymret over det.
English: Your doctor will tell you if this applies to you.
Danish: Din læge vil fortælle dig, hvis dette gælder for dig.
English: 3 Parallel arms:
Danish: 3 parallelle arme:
English: However, this difference is not considered to be clinically relevant.
Danish: Denne forskel anses dog ikke for at være klinisk relevant.
English: Maximum effects were generally observed within 6 weeks.
Danish: De maksimale effekter blev generelt observeret inden for 6 uger.
English: • Japanese or Korean patients.
Danish: • japanske eller koreanske patienter.
English: Date of first authorisation: 22 March 2017
Danish: Dato for første markedsføringstilladelse: 22. marts 2017
English: Active control (ADA)
Danish: Aktiv kontrol (ADA)
English: This treatment difference was consistent between the 2 subgroups (Table 16).
Danish: Denne behandlingsforskel var konsistent mellem de to undergrupper (Tabel 16).
English: OPAL BEYOND had a duration of 6 months.
Danish: OPAL BEYOND havde en varighed på 6 måneder.
English: Treatment should be symptomatic and supportive.
Danish: Behandlingen skal være symptomatisk og støttende.
English: Talk to your doctor if you smoke.
Danish: Tal med din læge, hvis du ryger.
English: Increases were observed at this time point and remained stable thereafter.
Danish: Der blev observeret stigninger på dette tidspunkt, og de forblev herefter stabile.
English: Antimalarials were allowed.
Danish: Malariamidler var tilladt.
English: Not known (cannot be estimated from the available data)
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværen de data
English: Take your next tablet at the usual time and continue as before.
Danish: Tag den næste tablet på det sædvanlige tidspunkt og fortsæt som før.
English: There was no clear relationship between neutropenia and the occurrence of serious infections.
Danish: Der var ingen klar relation mellem neutropeni og forekomst af alvorlige infektioner.
English: PK Ratio and 90% CI
Danish: PK Ratio og 90 % CI
English: Ratio relative to reference
Danish: Ratio i forhold til reference
English: Formal studies of the potential effect on human fertility have not been conducted.
Danish: Der er ikke udført formelle studier af den mulige effekt på human fertilitet.
English: The treatment interruption period in clinical studies extended up to 1 year.
Danish: Seponeringsperioden i kliniske studier strakte sig op til 1 år.
English: • If your treatment is interrupted, your doctor may decide to restart your treatment.
Danish: • Hvis din behandling afbrydes, kan din læge beslutte at starte din behandling på ny.
English: Retreatment in UC
Danish: Genbehandling ved UC
English: These responses were similar to those observed in healthy volunteers aged 50 years and older.
Danish: Disse responser var lig det, der blev observeret hos raske frivillige på 50 år og derover.
English: Some patients have presented with disseminated rather than localised disease.
Danish: Visse patienter viste dissemineret snarere end lokaliseret sygdom.
English: Child Pugh A No dose adjustment required.
Danish: Child Pugh A Ingen dosisjustering påkrævet.
English: He / she will also evaluate whether your body weight, age, or problems being mobile will affect your risk to develop blood clots.
Danish: Han/hun vil også tage stilling til om din vægt, alder eller mobilitetsproblemer kan påvirke risikoen for, at du udvikler blodpropper.
English: *Spontaneous reporting data
Danish: *Spontant rapporterede data.
English: You can take XELJANZ with or without food.
Danish: Du kan tage XELJANZ med eller uden mad.
English: • who have underlying conditions that may predispose them to infection.
Danish: • som har underliggende tilstande, der kan prædisponere for infektion
English: The available data have also shown that there are no major differences in tofacitinib AUC between White, Black and Asian patients.
Danish: De tilgængelige data viser også, at der ikke er nogen større forskel i AUC for tofacitinib mellem hvide, sorte og asiatiske patienter.
English: There are no adequate and well-controlled studies on the use of tofacitinib in pregnant women.
Danish: Der foreligger ikke tilstrækkelige og velkontrollerede studier med anvendelse af tofacitinib hos gravide kvinder.
English: Your doctor will decide whether you need to have herpes zoster vaccination.
Danish: Din læge vil afgøre, om du har brug for en vaccine mod herpes zoster.
English: These changes generally resolved within 2-6 weeks after discontinuation of treatment.
Danish: Disse ændringer forsvandt generelt inden for 2-6 uger efter seponering.
English: Try to take your tablet at the same time every day (one tablet in the morning and one tablet in the evening).
Danish: Sørg for at tage tabletten på samme tidspunkt hver dag (en tablet om morgenen og en tablet om aftenen).
English: BID=twice daily.
Danish: BID = To gange dagligt.
English: For patients with Baseline score > 0.
Danish: For patienter med en baseline score > 0.
English: Maintenance (OCTAVE Sustain)
Danish: Vedligeholdelse (OCTAVE Sustain)
English: Treatment groups (randomisation ratio)
Danish: Behandlingsgrupper (Randomiseringsratio)
English: You should tell your doctor if you are using medicines (taken by mouth) that contain any of the following active substances:
Danish: Du skal fortælle det til lægen, hvis du bruger medicin (som tages gennem munden), der indeholder et eller flere af følgende aktive stoffer:
English: Patients were required to have active plaque psoriasis at the screening visit.
Danish: Det var påkrævet, at patienterne havde aktiv plaque psoriasis ved screeningsbesøget.
English: Some may be serious and need medical attention.
Danish: Nogle af bivirkningerne kan være alvorlige og kræve lægehjælp.
English: Tell your doctor immediately if you feel unwell.
Danish: Fortæl det straks til lægen, hvis du føler dig utilpas.
English: Do not use this medicine if you notice the tablets show visible signs of deterioration (for example, are broken or discoloured).
Danish: Brug ikke denne medicin, hvis du opdager, at tabletterne udviser tegn på beskadigelse (for eksempel er gået i stykker eller er misfarvede).
English: Note: Reference group is administration of tofacitinib alone.
Danish: Bemærk: Reference er administration af tofacitinib alene.
English: - if you have or had hepatitis B or hepatitis C (viruses that affect the liver).
Danish: - hvis du har eller har haft hepatitis B eller hepatitis C (virus, som påvirker leveren).
English: Tell your doctor as soon as you notice any signs or symptoms of infections.
Danish: Fortæl det til lægen, så snart du bemærker tegn eller symptomer på en infektion.
English: Combination with other therapies
Danish: Kombination med andre behandlinger
English: Month 6 and month 12 data are mean change from baseline d
Danish: Måned 6- og Måned 12-data er den gennemsnitlige ændring fra baseline d
English: Tofacitinib is given orally with or without food.
Danish: Tofacitinib gives oralt med eller uden mad.
English: Once daily Do not swallow the desiccant.
Danish: Én gang dagligt Undlad at synke tørremidlet.
English: Tofacitinib is well-absorbed, with an oral bioavailability of 74%.
Danish: Tofacitinib absorberes godt og har en oral biotilgængelighed på 74 %.
English: Women were estimated to have 7% lower AUC compared to men.
Danish: Det blev estimeret, at AUC for kvinder er 7 % mindre end for mænd.
English: Tofacitinib distributes equally between red blood cells and plasma.
Danish: Tofacitinib fordeles ligeligt mellem røde blodlegemer og plasma.
English: N=number of patients in the analysis set.
Danish: N = Antallet af patienter i analysesættet.
English: SD = Standard Deviation b
Danish: SD = Standardafvigelse b
English: The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
Danish: Indholdet af sorbitol i lægemidler til oral brug kan påvirke biotilgængeligheden af andre lægemidler til oral brug ved samtidig administration.
English: • Patients undergoing major surgery
Danish: • Patienter, som undergår større operationer
English: Health-related quality of life was assessed by the Short Form Health Survey (SF-36).
Danish: Helbredsrelateret livskvalitet blev vurderet ved hjælp af Short Form Health Survey (SF-36).
English: • who have been exposed to TB,
Danish: • har været eksponeret for TB
English: The number of patients with arthritis mutilans or axial involvement was too small to allow meaningful assessment.
Danish: Antallet af patienter med artritis mutilans eller aksial involvering var for lille til at kunne foretage en meningsfuld vurdering.
English: The median PsA disease duration was 7.5 years.
Danish: Medianvarighed af PsA var 7,5 år.
English: The median PsA disease duration was 3.8 years.
Danish: Medianvarighed af PsA var 3,8 år.
English: Treatment should be interrupted if a patient develops a serious infection, an opportunistic infection, or sepsis.
Danish: Behandlingen skal afbrydes, hvis en patient udvikler en alvorlig infektion, en opportunistisk infektion eller sepsis.
English: The efficacy results for important endpoints assessed are shown in Table 12.
Danish: Effektresultaterne for de vigtige effektmål er vist i tabel 12.
English: XELJANZ may increase your risk of certain cancers.
Danish: XELJANZ kan øge din risiko for visse former for kræft.
English: This condition is an inflammatory disease of the joints, often accompanied by psoriasis.
Danish: Denne sygdom er en betændelsessygdom i leddene, som ofte er ledsaget af psoriasis.
English: Corticosteroid tapering was also required upon entrance into OCTAVE Open.
Danish: Nedtrapning af kortikosteroider var også påkrævet ved inklusionen i OCTAVE Open.
English: - if you have heart problems, high blood pressure, or high cholesterol
Danish: - hvis du har problemer med hjertet, forhøjet blodtryk eller forhøjet kolesterol.
English: Tofacitinib should not be initiated in patients with active infections, including localised infections.
Danish: Tofacitinib bør ikke påbegyndes hos patienter med aktive infektioner, inklusive lokale infektioner.
English: Prior to launch of XELJANZ in each Member State, the MAH must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Før lancering af XELJANZ i de enkelte EU-lande skal MAH aftale indhold og form af uddannelsesprogrammet, herunder kommunikation med medier, distribution af materialet og andre aspekter af programmet med den nationale lægemiddelmyndighed.