FrancophonIA/ELRC3.0 huggingface dataset:
English: Weekly monitoring is required at the start of treatment and the patient should continue to be monitored at least every 3 months for the first year.
Danish: I begyndelsen af behandlingen behøves overvågning en gang om ugen, og patienten bør fortsat overvåges mindst hver 3. måned i det første år.
English: Sleepiness usually begins at the start of treatment and lasts for 2 to 3 weeks.
Danish: Søvnighed begynder sædvanligvis ved påbegyndelse af behandlingen og varer i 2-3 uger.
English: This is a summary of the European public assessment report (EPAR) for Intuniv.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Intuniv.
English: The full EPAR and risk management plan summary for Intuniv 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 Intuniv 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 Intuniv is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Intuniv anvendes så sikkert som muligt.
English: Intuniv is used as part of a comprehensive treatment programme that typically involves psychological, educational and other interventions.
Danish: Intuniv anvendes som led i et omfattende behandlingsprogram, der typisk omfatter psykologiske, uddannelsesmæssige og andre indgreb.
English: Other information about Intuniv
Danish: Andre oplysninger om Intuniv
English: The active substance in Intuniv is guanfacine.
Danish: Det aktive stof i Intuniv er guanfacine.
English: The most important safety risks are slow heart rate, low blood pressure, fainting, sleepiness and sedation.
Danish: De vigtigste sikkerhedsrisici er langsom hjertefrekvens, lavt blodtryk, besvimelsesanfald, søvnighed og døsighed.
English: The education material should include information on side effects, a checklist to identify children at risk, and a checklist and chart for monitoring children during treatment.
Danish: Oplysningsmaterialet skal omfatte oplysninger om bivirkninger, en tjekliste, der udpeger børn med risiko, og en tjekliste og et diagram til overvågning af børnene under behandlingen.
English: Before starting treatment, the doctor should carry out checks to see whether the patient is at risk of side effects of the medicine (particularly sleepiness, effects on heart rate and blood pressure, and weight gain).
Danish: Før påbegyndelse af behandlingen bør lægen kontrollere, om patienten har risiko for bivirkninger fra lægemidlet (navnlig søvnighed, påvirkning af hjertefrekvens og blodtryk, og vægtøgning).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that stimulant medicines are first line treatments for ADHD and that these medicines provide a larger and more consistent improvement in ADHD symptoms as part of a comprehensive treatment programme.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) bemærkede, at stimulerende lægemidler er førstevalgsbehandling ved ADHD, og at disse lægemidler giver en større og mere ensartet bedring i symptomerne på ADHD som led i et omfattende behandlingsprogram.
English: The CHMP therefore concluded that the benefits of Intuniv outweigh the risks recommended that it be approved for authorisation in the EU.
Danish: CHMP konkluderede derfor, at fordelene ved Intuniv overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse i EU.
English: The dose of Intuniv requires careful adjustments, taking account side effects and benefits seen in the patient.
Danish: Dosis af Intuniv kræver omhyggelig justering under hensyntagen til bivirkninger og gavnlige virkninger hos patienten.
English: What measures are being taken to ensure the safe and effective use of Intuniv?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Intuniv?
English: The company that markets Intuniv must also provide nationally agreed educational material for healthcare professionals before launching the medicine on the market.
Danish: Den virksomhed, der markedsfører Intuniv, skal desuden udlevere nationalt godkendt oplysningsmateriale til sundhedspersoner, før lægemidlet bringes på markedet.
English: It is thought that the active substance, guanfacine, might influence the way signals are transmitted between cells in areas of the brain called the prefrontal cortex and basal ganglia by attaching to certain receptors that are heavily concentrated in these areas.
Danish: Det aktive stof, guanfacine, kan måske påvirke den måde, hvorpå signalerne overføres mellem cellerne i de områder af hjernen, der kaldes af den præfrontale cortex og basalganglierne.
English: It is not intended to provide practical advice on how to use Intuniv.
Danish: Det er ikke en praktisk vejledning i, hvordan Intuniv bør anvendes.
English: However, given the benefits seen with Intuniv, the Committee concluded that the medicine can be used as an alternative in patients who cannot take stimulants or in patients in whom stimulants do not control their symptoms well enough.
Danish: På baggrund af de fordele, der ses ved Intuniv, konkluderede udvalget imidlertid, at lægemidlet kan anvendes som et alternativ hos patienter, hos hvem stimulerende lægemidler ikke kan anvendes eller ikke kontrollerer symptomerne godt nok.
English: Intuniv was also evaluated in terms of treatment failures (based either on worsening of ADHD symptoms or patients stopping treatment).
Danish: Intuniv blev desuden vurderet i form af behandlingssvigt (baseret enten på forværring af ADHDsymptomer eller på ophør af behandlingen).
English: Intuniv is used to treat attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years when stimulant medicines are not appropriate or do not control their symptoms well enough.
Danish: Intuniv anvendes til behandling af hyperaktiv opmærksomhedsforstyrrelse (ADHD) hos børn og unge mellem 6 og 17 år, når stimulerende lægemidler ikke er hensigtsmæssige eller ikke kontrollerer symptomerne godt nok.
English: Two other short-term studies involving 631 patients also showed Intuniv at various doses improving ADHD scores more than placebo.
Danish: To andre kortvarige undersøgelser med 631 patienter viste også, at Intuniv i forskellige doser forbedrer ADHD-score mere end placebo.
English: The way Intuniv works in ADHD is not established.
Danish: Den nøjagtige måde, Intuniv virker på ved ADHD, er ikke fastlagt.
English: What is Intuniv and what is it used for?
Danish: Hvad er Intuniv, og hvad anvendes det til?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Intuniv, 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 Intuniv, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Several studies have shown Intuniv improving ADHD symptom scores (ADHD-RS-IV) in children and adolescents.
Danish: Flere undersøgelser har vist, at Intuniv bedrer symptomscore ved ADHD (ADHD-RS-IV) hos børn og unge.
English: The most common side effects with Intuniv are sleepiness (in nearly half of all patients), headache (in more than a quarter), tiredness (in about 1 patient in 5), and upper abdominal pain and sedation (both in around 1 in 10).
Danish: De hyppigste bivirkninger ved Intuniv er søvnighed (hos næsten halvdelen af alle patienterne), hovedpine (hos over 1 ud af 4), træthed (hos omkring 1 patient ud af 5) og smerter i den øvre del af maveområdet og døsighed (begge hos omkring 1 ud af hver 10).
English: Why is Intuniv approved?
Danish: Hvorfor blev Intuniv godkendt?
English: Intuniv treatment must be started by a doctor specialised in childhood or adolescent behavioural problems.
Danish: Behandling med Intuniv skal påbegyndes af en læge, der er specialiseret i adfærdsforstyrrelser hos børn og unge.
English: For more information about treatment with Intuniv, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Intuniv, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the risks associated with Intuniv?
Danish: Hvilke risici er der forbundet med Intuniv?
English: In a long-term maintenance study in 301 children and adolescents aged 6 to 17 years treatment failures occurred in 49% of patients taking Intuniv compared with 65% of those taking placebo.
Danish: I en langvarig vedligeholdelsesundersøgelse hos 301 børn og voksne i alderen 6-17 år var der behandlingssvigt hos 49 % af de patienter, der fik Intuniv, sammenholdt med 65 % af dem, der fik placebo.
English: More serious side effects are less common and include: low blood pressure and weight gain (both in around 1 patient in 30), slow heart rate (1 in 60) and fainting (in less than 1 in 100).
Danish: For lavt blodtryk samt vægtøgning (begge hos omkring 1 patient ud af 30), langsom hjertefrekvens (1 ud af 60) og besvimelsesanfald (hos mindre end 1 ud af 100).
English: The medicine can only be obtained with a prescription
Danish: Lægemidlet Intuniv udleveres kun efter recept.
English: For practical information about using Intuniv, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Intuniv, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In a study of 337 children aged 6 to 17 years, the reduction in ADHD symptoms with Intuniv treatment after 10 to 13 weeks was 24 points compared with a reduction of 15 points seen with placebo (a dummy treatment) and 19 points seen with atomoxetine (an ADHD medicine).
Danish: I en undersøgelse med 337 børn mellem 6 og 17 år var reduktionen i ADHD-symptomer ved behandling med Intuniv 24 point efter 10-13 uger, sammenholdt med en reduktion på 15 point ved virkningsløs behandling (placebo) og 19 point med ADHD-lægemidlet atomoxetin.
English: For information on dose adjustments and checks to be carried out by the doctor, see the summary of product characteristics (SmPC).
Danish: Vedrørende oplysninger om de dosisjusteringer og kontroller, der skal foretages af lægen, henvises til produktresuméet.
English: In another study of 312 adolescents aged 13 to 17, the reduction in ADHD scores at 13 weeks was 25 points with Intuniv and 19 points with placebo.
Danish: I en anden undersøgelse med 312 unge i alderen 13-17 år var reduktionen i ADHD-score efter 13 uger 25 point med Intuniv og 19 point med placebo.
English: How is Intuniv used?
Danish: Hvordan anvendes Intuniv?
English: What benefits of Intuniv have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Intuniv?
English: How does Intuniv work?
Danish: Hvordan virker Intuniv?
English: Regarding safety, the treatment is well tolerated.
Danish: Hvad sikkerheden angår, tåles behandlingen godt.
English: Results in children aged below 12 years are not yet available.
Danish: Der foreligger endnu ingen resultaterne for børn under 12 år.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Harvoni on 17 November 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Harvoni den 17. november 2014.
English: Sofosbuvir has been authorised as Sovaldi since January 2014.
Danish: Sofosbuvir har været godkendt under navnet Sovaldi siden januar 2014.
English: It must also not be used together with the following medicines which can reduce the effects of Harvoni:
Danish: Det må heller ikke anvendes sammen med følgende lægemidler, som kan reducere virkningen af Harvoni:
English: This is a summary of the European public assessment report (EPAR) for Harvoni.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Harvoni.
English: The full EPAR and risk management plan summary for Harvoni 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 Harvoni findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Harvoni
Danish: Andre oplysninger om Harvoni
English: In these studies, patients were given Harvoni, with or without ribavirin, for 8, 12 or 24 weeks, depending on the characteristics of the patients.
Danish: I disse undersøgelser fik patienterne Harvoni med eller uden ribavirin i 8, 12 eller 24 uger, afhængigt af patientens karakteristika.
English: Patients whose infection was resistant to other antiviral medicines could also benefit from extending treatment to 24 weeks.
Danish: Patienter, hvis infektion var resistent mod andre antivirale lægemidler, kunne også have gavn af, at behandlingsperioden blev forlænget til 24 uger.
English: The addition of ribavirin was not needed for most patients.
Danish: Tillægsbehandling med ribavirin var unødvendig hos størstedelen af patienterne.
English: What measures are being taken to ensure the safe and effective use of Harvoni?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Harvoni?
English: Harvoni must not be used together with the cholesterol medicine rosuvastatin.
Danish: Harvoni må ikke anvendes sammen med det kolesterolnedsættende lægemiddel rosuvastatin.
English: The European Medicines Agency decided that Harvoni's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Harvoni opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: • rifampicin and rifabutin (antibiotics);
Danish: • rifampicin og rifabutin (antibiotika)
English: This study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early.
Danish: Denne undersøgelse gennemføres på baggrund af data, der indikerer, at patienter, som behandles med disse lægemidler, og som har haft leverkræft, kunne være i risiko for, at deres kræft vender hurtigere tilbage.
English: Sofosbuvir blocks the action of a protein called ‘NS5B RNA-dependent RNA polymerase', while ledipasvir targets a protein called ‘NS5A'.
Danish: Sofosbuvir blokerer virkningen af et protein kaldet "NS5B RNA-afhængig RNA-polymerase", mens ledipasvir virker på proteinet "NS5A".
English: Supportive data showed that Harvoni in combination with ribavirin would be of benefit for some patients with genotype 3 virus.
Danish: Støttende data viste, at Harvoni i kombination med ribavirin ville være til gavn for visse patienter med virus af genotype 3.
English: Why is Harvoni approved?
Danish: Hvorfor blev Harvoni godkendt?
English: The most common side effects with Harvoni (which may affect more than 1 in 10 people) are tiredness and headache.
Danish: De hyppigste bivirkninger ved Harvoni (som optræder hos mere end 1 ud af 10 patienter) er træthed og hovedpine.
English: What is Harvoni and what is it used for?
Danish: Hvad er Harvoni, og hvad anvendes det til?
English: • carbamazepine, phenobarbital and phenytoin (medicines for epilepsy);
Danish: • carbamazepin, phenobarbital og phenytoin (lægemidler mod epilepsi)
English: • St John's wort (a herbal preparation used to treat depression and anxiety).
Danish: • prikbladet perikum (plantepræparat, som anvendes til behandling af depression og ængstelse).
English: By blocking these proteins, Harvoni stops the hepatitis C virus from multiplying and infecting new cells.
Danish: Ved at blokere disse proteiner forhindrer Harvoni hepatitis C-virusset i at formere sig og inficere nye celler.
English: Harvoni is available as tablets which contain 90 mg ledipasvir and 400 mg sofosbuvir.
Danish: Harvoni fås som tabletter, der indeholder 90 mg ledipasvir og 400 mg sofosbuvir.
English: The company that markets Harvoni will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Harvoni.
Danish: Virksomheden, der markedsfører Harvoni, vil gennemføre en undersøgelse blandt patienter, der tidligere har haft leverkræft, for at evaluere risikoen for, at leverkræften vender tilbage efter behandling med direkte virkende antivirale lægemidler som Harvoni.
English: What are the risks associated with Harvoni?
Danish: Hvilke risici er der forbundet med Harvoni?
English: Around 94% to up to 99% of patients given Harvoni alone had no sign of the virus 12 weeks after the end of treatment.
Danish: Mellem 94 % og 99 % af de patienter, der fik Harvoni alene, viste intet tegn på virusset 12 uger efter afslutningen af behandlingen.
English: It is not intended to provide practical advice on how to use Harvoni.
Danish: Det er ikke en praktisk vejledning i, hvordan Harvoni bør anvendes.
English: Harvoni can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.
Danish: Harvoni udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af patienter med kronisk hepatitis C.
English: The active substances in Harvoni, ledipasvir and sofosbuvir, block two proteins essential for the hepatitis C virus to multiply.
Danish: De aktive stoffer i Harvoni, ledipasvir og sofosbuvir, blokerer to proteiner, som hepatitis C-virusset behøver for at formere sig.
English: Harvoni is also being investigated in a study in children aged 3 to 18 years infected with hepatitis C. Results from 100 patients aged 12 to 18 years (all of whom had hepatitis C genotype 1) showed that 98% of them had no sign of the virus 12 weeks after the end of treatment.
Danish: Harvoni er også genstand for en undersøgelse hos børn i alderen tre til 18 år, som er smittet med hepatitis C. Resultaterne fra 100 patients i alderen 12 til 18 år (hvoraf alle havde hepatitis C af genotype 1) viste, at 98 % af dem ikke viste tegn på virusset 12 uger efter afslutningen af behandlingen.
English: In all three studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 12 weeks after the end of treatment.
Danish: I alle tre undersøgelser blev behandlingens virkning hovedsagelig bedømt på den andel af patienterne, hvis blodprøver ikke viste tegn på hepatitis C-virus 12 uger efter afslutningen af behandlingen.
English: Harvoni contains the active substances ledipasvir and sofosbuvir.
Danish: Harvoni indeholder de aktive stoffer ledipasvir og sofosbuvir.
English: For more information about treatment with Harvoni, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Harvoni, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For the full list of all side effects and restrictions with Harvoni, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Harvoni fremgår af indlægssedlen.
English: The duration of treatment with Harvoni and whether it is used alone or in combination with another medicine called ribavirin depends on the genotype of the virus and the nature of the liver problems patients have, for example if they have liver cirrhosis (scarring) or their liver is not working properly.
Danish: Hvor længe man skal behandles med Harvoni, og om det skal bruges alene eller i kombination med et andet lægemiddel, ribavirin, afhænger af virussets genotype og arten af patientens leverproblemer, f.eks. om patienten har skrumpelever (cirrhose), og om leveren fungerer unormalt.
English: Results of the studies also showed that patients who have compensated cirrhosis (scarring of the liver but the liver continues to work adequately) had a higher likelihood of clearing the virus when treatment was extended to 24 weeks.
Danish: Resultaterne af undersøgelserne viste desuden, at de patienter, der havde skrumpelever, men hvor leveren fortsat fungerede tilstrækkeligt (kompenseret cirrhose), havde større sandsynlighed for at blive virusfrie, når behandlingen blev forlænget til 24 uger.
English: Benefit of Harvoni was also shown for patients with genotype 4, 5 and 6, for those with decompensated cirrhosis (when the liver does not work adequately) and for those who had received a liver transplant.
Danish: Harvoni viste også fordele for patienter med genotype 4, 5 og 6, for patienter med dekompenseret cirrhose (når leveren ikke fungerer tilstrækkeligt) og patienter, der havde fået foretaget en levertransplantation.
English: Harvoni has been investigated in three main studies involving a total of around 2,000 adult patients infected with hepatitis C of genotype 1 whose liver function was normal.
Danish: Harvoni har været genstand for tre hovedundersøgelser med i alt ca. 2 000 voksne patienter, der var smittet med hepatitis C af genotype 1, og som havde normal leverfunktion.
English: Harvoni is an antiviral medicine used to treat adults and children from 12 years of age with chronic (long-term) hepatitis C, an infectious disease that affects the liver caused by the hepatitis C virus.
Danish: Harvoni er et antiviralt lægemiddel, der anvendes til behandling af voksne og børn på 12 år og derover med langvarig (kronisk) hepatitis C, en smitsom sygdom, der angriber leveren og forårsages af hepatitis C-virus.
English: Harvoni, with or without ribavirin, is highly beneficial for many patients with hepatitis C virus, including those who have had a liver transplant and/or who have compensated or decompensated cirrhosis.
Danish: Agenturet fandt, at behandling med Harvoni med eller uden ribavirin er yderst gavnlig for mange patienter med hepatitis C-virus, herunder patienter, der har fået foretaget en levertransplantation, og/eller som har kompenseret eller dekompenseret cirrhose.
English: For practical information about using Harvoni, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Harvoni, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What benefits of Harvoni have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Harvoni?
English: How is Harvoni used?
Danish: Hvordan anvendes Harvoni?
English: There are several varieties (called genotypes) of hepatitis C virus and Harvoni is recommended for use in patients with virus of genotypes 1, 4, 5 and 6 and for some patients with genotype 3.
Danish: Harvoni anbefales til patienter med virus af genotype 1, 4, 5 og 6 samt til visse patienter med genotype 3.
English: How does Harvoni work?
Danish: Hvordan virker Harvoni?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Harvoni 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 Harvoni.
English: 1 ml (20 mg/ml) 10 pre-filled syringes
Danish: 1 ml (20 mg/ml) 10 fyldte injektionssprøjter
English: 2.5 mg Solution for injection
Danish: 2,5 mg Injektionsvæske, opløsning
English: It was to be available as white tablets.
Danish: Det skulle have været leveret som hvide tabletter.
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Danish: Brevet fra virksomheden, hvori EMA underrettes om tilbagetrækning af ansøgningen, kan ses under “All documents".