FrancophonIA/ELRC3.0 huggingface dataset:
English: • Wipe the injection site on the skin with an antiseptic wipe
Danish: • Tør injektionsstedet af med en desinficerende serviet.
English: Table 6 Number of patients who achieved clinical response in Psoriatic arthritis Study 1 (PSUMMIT I) and Study 2 (PSUMMIT II) at week 24
Danish: Tabel 6 Antal patienter, der opnåede klinisk respons i psoriasisartritstudie 1 (PSUMMIT I) og psoriasisartritstudie 2 (PSUMMIT II) i uge 24 Psoriasisartritstudie 1 Psoriasisartritstudie 2 PBO 45 mg 90 mg PBO 45 mg 90 mg
English: Significantly higher proportions of patients maintained clinical remission and response in the ustekinumab treated groups compared to the placebo group at week 44 (see Table 4).
Danish: En signifikant højere andel af patienterne i ustekinumab-gruppen havde vedvarende klinisk remission og respons sammenlignet med placebo-gruppen i uge 44 (se tabel 4).
English: You should tell your doctor straight away if you notice any of these signs.
Danish: Kontakt straks lægen, hvis du bemærker et af disse tegn.
English: Table 6: Summary of Key Efficacy Measures in UNIFI-M (week 44; 52 weeks from initiation of the induction dose)
Danish: Tabel6:Oversigtover de væsentligste effektresultateri UNIFI-M (uge44,52uger fra initiering af induktionsdosen)
English: • the number of pre-filled syringes and strength is correct o If your dose is 90 mg you will get one 90 mg pre-filled syringe of Stelara.
Danish: • at antallet af hætteglas og styrken er korrekt o Hvis din dosis er 45 mg eller mindre, får du et hætteglas med 45 mg Stelara.
English: What Stelara is and what it is used for What you need to know before you use Stelara How to use Stelara
Danish: Virkning og anvendelse Det skal du vide, før du får Stelara Sådan får du Stelara
English: Significantly greater proportions of patients were in clinical remission in both ustekinumab treated groups compared to the placebo group at week 44 (see Table 12).
Danish: En signifikant højere andel af patienterne i begge ustekinumab-grupper havde klinisk remission sammenlignet med placebo-gruppen i uge44 (se tabel12).
English: STELARA 130 mg concentrate for solution for infusion
Danish: STELARA 130 mg koncentrat til infusionsvæske, opløsning
English: Each pre-filled syringe contains 45 mg ustekinumab in 0.5 mL of solution for injection.
Danish: Hver fyldt injektionssprøjte indeholder 45 mg ustekinumab i 0,5 ml injektionsvæske.
English: • the number of pre-filled syringes and strength is correct o If your dose is 45 mg you will get one 45 mg pre-filled syringe of Stelara o If your dose is 90 mg you will get two 45 mg pre-filled syringes of Stelara and you will need to give yourself two injections.
Danish: o Hvis din dosis er 90 mg, skal du have to 45 mg fyldte Stelara-injektionssprøjter, og du skal give dig selv to injektioner.
English: Each vial contains 90 mg ustekinumab in 1 mL of solution for injection.
Danish: Hvert hætteglas indeholder 90 mg ustekinumab i 1 ml injektionsvæske.
English: STELARA 45 mg solution for injection in pre-filled syringe Solution for injection.
Danish: STELARA 45 mg injektionsvæske, opløsning i fyldt injektionssprøjte Injektionsvæske, opløsning.
English: • Do not shake Stelara pre-filled syringes.
Danish: • Ryst ikke den fyldte Stelara-injektionssprøjte.
English: STELARA 90 mg solution for injection in pre-filled syringe Solution for injection.
Danish: STELARA 90 mg injektionsvæske, opløsning i fyldt injektionssprøjte.
English: 0.5 mL.
Danish: 5.1, pkt.
English: Each vial contains 45 mg ustekinumab in 0.5 mL of solution for injection.
Danish: Hvert hætteglas indeholder 45 mg ustekinumab i 0,5 ml injektionsvæske.
English: VIAL CARTON TEXT (90 mg)
Danish: PAKNING MED HÆTTEGLAS (90 mg)
English: STELARA 90 mg solution for injection in pre-filled syringe Ustekinumab
Danish: STELARA 90 mg injektionsvæske, opløsning i fyldt injektionssprøjte ustekinumab
English: STELARA 45 mg solution for injection in pre-filled syringe Ustekinumab
Danish: STELARA 45 mg injektionsvæske, opløsning i fyldt injektionssprøjte ustekinumab
English: Dispose of your sharps container according to your local regulations
Danish: Beholderen med brugte sprøjter bortskaffes i henhold til lokale myndighedskrav.
English: If you forget a dose, contact your doctor or pharmacist.
Danish: Kontakt lægen eller apotekspersonalet, hvis du glemmer en dosis.
English: In patients who failed biological therapy In patients who failed both a TNF and vedolizumab 28% (13/47) Mucosal Healing
Danish: hos patienter, som ikke responderede på biologisk behandling hos patienter, som ikke responderede hverken på en TNF eller vedolizumab Opretholdelse af klinisk respons til uge 44 hos patienter uden respons på konventionel behandling, men kan have responderet på et biologisk middel c 77% (78/102)
English: Systemic
Danish: Administration
English: How Stelara will be given
Danish: Sådan får du Stelara
English: The European Commission granted a marketing authorisation valid throughout the European Union for Suboxone on 26 September 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Suboxone den 26. august 2006.
English: The tablets must never be swallowed but should be placed under the tongue and allowed to dissolve, which usually takes five to 10 minutes.
Danish: Tabletterne må aldrig sluges, men skal anbringes under tungen og have tid til at opløse sig, hvilket normalt tager fem til 10 minutter.
English: This document is a summary of the European public assessment report (EPAR) for Suboxone.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Suboxone.
English: Suboxone buprenorphine / naloxone
Danish: Suboxone buprenorphin/naloxon
English: ‘Sublingual' means that the tablet is placed under the tongue where it dissolves.
Danish: "Sublingual" betyder, at tabletten lægges under tungen, hvor den opløses.
English: A risk management plan has been developed to ensure that Suboxone is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Suboxone anvendes så sikkert som muligt.
English: The doctor may increase the dose depending on the patient's response but the daily dose should not be higher than 24 mg buprenorphine.
Danish: Lægen kan øge dosis, afhængigt af patientens respons, men den daglige dosis må ikke oversige 24 mg buprenorphin.
English: Sublingual tablets containing buprenorphine alone have been available in the EU since the mid-1990's for the treatment of opioid addiction.
Danish: De sublinguale tabletter, som indeholder buprenorphin alene, har kunnet fås i EU siden midten af 1990'erne til behandling af opioid afhængighed.
English: Other information about Suboxone
Danish: Andre oplysninger om Suboxone
English: What measures are being taken to ensure the safe and effective use of Suboxone?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Suboxone?
English: Suboxone is used in adults and children over 15 years of age, who are also receiving medical, social and psychological support.
Danish: Suboxone anvendes til voksne og unge over 15 år, som samtidigt modtager medicinsk, social og psykologisk støtte.
English: Patients also used a specially designed questionnaire to record their cravings, and the change in the questionnaire score before and at the end of the study was measured.
Danish: Patienterne anvendte også et specielt udformet spørgeskema til registrering af deres trang til stoffer, hvor ændringer i scoren i spørgeskemaet blev målt før og efter undersøgelsen.
English: In patients who have mild to moderately reduced liver function lower starting doses are recommended.
Danish: Hos patienter med let til moderat nedsat leverfunktion anbefales lavere startdoser.
English: Once the patient has been stabilised, the maintenance dose may be reduced gradually and eventually treatment may be stopped.
Danish: Når patienten først er stabiliseret, kan vedligeholdelsesdosis reduceres gradvist, hvorefter behandlingen med tiden kan ophøre.
English: It is recommended that the patient's liver be checked before starting treatment with Suboxone and should also be monitored regularly during treatment.
Danish: Det anbefales, at patientens lever kontrolleres, inden der indledes behandling med Suboxone, og leveren bør også overvåges regelmæssigt under behandlingen.
English: The Committee decided that Suboxone's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget fandt, at fordelene ved Suboxone opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
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 Suboxone.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Suboxone skal anvendes.
English: The recommended starting dose is one or two tablets of Suboxone 2 mg/0.5 mg.
Danish: Den anbefalede startdosis er en eller to tabletter af Suboxone 2 mg/0,5 mg.
English: The effectiveness of Suboxone treatment depends on the patient also receiving other medical, social and psychological support.
Danish: Effektiviteten af Suboxone-behandlingen afhænger af, om patienten også modtager medicinsk, social og psykologisk støtte.
English: Suboxone must be used under the supervision of a doctor who has experience in the management of opioid addiction.
Danish: Suboxone skal anvendes under overvågning af en læge, der har erfaring i behandling af opioidafhængighed.
English: The craving score, which was between 62.4 and 65.6 before treatment, decreased at the end of the study to 29.8 with Suboxone, compared with 55.1 with placebo.
Danish: Scoren for trang til stoffer, som lå mellem 62,4 og 65,6 inden behandlingen, var ved undersøgelsens afslutning faldet til 29,8 med Suboxone sammenlignet med 55,1 med placebo.
English: The CHMP noted that the combination of an opioid analogue with an opioid antagonist is an established strategy for reducing the potential misuse of the medicine.
Danish: CHMP bemærkede, at kombinationen af en opioidanalog med en opioidantagonist er en velkendt strategi for at mindske et potentielt misbrug af lægemidlet.
English: The way Suboxone is used depends on the patient's status: type of addiction, state of withdrawal, and whether the patient is already using another substitution treatment such as methadone before starting Suboxone.
Danish: Den måde, hvorpå Suboxone anvendes, afhænger af patientens status: misbrugets art, abstinensstatus og hvorvidt patienten allerede modtager en anden substitutionsbehandling såsom metadon, inden der indledes behandling med Suboxone.
English: However, buprenorphine tablets have been misused by drug addicts who dissolve the tablets and inject themselves with the resulting solution.
Danish: Buprenorphintabletterne er imidlertid blevet misbrugt af stofmisbrugere, som opløser tabletterne og selv tager indsprøjtninger med denne opløsning.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Suboxone, 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 Suboxone, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: It is available as sublingual tablets containing 2 mg buprenorphine and 0.5 mg naloxone, 8 mg buprenorphine and 2 mg naloxone, or 16 mg buprenorphine and 4 mg naloxone.
Danish: Det fås som sublinguale tabletter, der indeholder 2 mg buprenorphin og 0,5 mg naloxon, 8 mg buprenorphin og 2 mg naloxon eller 16 mg buprenorphin og 4 mg naloxon.
English: Suboxone is a medicine that contains two active substances, buprenorphine and naloxone.
Danish: Suboxone er et lægemiddel, der indeholder to aktive stoffer, buprenorphin og naloxon.
English: Suboxone is used to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction.
Danish: Suboxone anvendes til behandling af afhængighed af opioide (narkotiske) lægemidler såsom heroin eller morfin hos stofmisbrugere, som har indvilget i at blive behandlet for deres afhængighed.
English: Suboxone was as effective as buprenorphine on its own and more effective than placebo: 17.8% of the patients who received Suboxone had a urine sample that tested negative at the end of the study, compared with 5.8% of the patients receiving placebo.
Danish: Suboxone var lige så effektivt som buprenorphin alene og mere effektivt end placebo: Urinprøven hos 17,8 % af de patienter, der fik Suboxone, blev testet negativ ved afslutningen af undersøgelsen sammenlignet 5,8 % af de patienter, der fik placebo.
English: Suboxone must not be used in patients with severe respiratory insufficiency (difficulty breathing) or severe liver problems.
Danish: Suboxone må ikke anvendes til patienter med svært nedsat vejrtrækning eller svære leverproblemer.
English: It must also not be used in patients with acute alcohol intoxication (excessive alcohol consumption), delirium tremens (a condition caused by alcohol withdrawal) or together with medicines known as opioid antagonists used for the treatment of alcohol or opioid dependence.
Danish: Det må heller ikke anvendes til patienter med akut alkoholforgiftning (overdrevent alkoholforbrug) eller delirium tremens (en tilstand forårsaget af alkoholabstinenser) eller sammen med opioidantagonister, dvs. lægemidler til behandling af alkohol- eller opioidafhængighed.
English: Suboxone contains two active substances: buprenorphine, a partial opioid agonist (it acts like an opioid drug), and naloxone, an opioid antagonists (it counteracts the effects of opioid drugs).
Danish: Suboxone indeholder to aktive stoffer, buprenorphin, en partiel opioidagonist (det virker som et opioidt lægemiddel), og naloxon, en opioid antagonist (det modvirker virkningerne af opioide lægemidler).
English: For the full list of all side effects reported with Suboxone, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Suboxone fremgår af indlægssedlen.
English: The most common side effects with Suboxone (seen in more than 1 patient in 10) are insomnia (difficulty sleeping), constipation, nausea (feeling sick), sweating, headache and withdrawal syndrome.
Danish: De hyppigste bivirkninger ved Suboxone (som optræder hos flere end 1 ud af 10 patienter) er søvnbesvær, forstoppelse, kvalme, svedtendens, hovedpine og abstinenssymptomer.
English: This is because, when injected, naloxone counteracts the effects of opioids, causing the patient to experience acute withdrawal symptoms.
Danish: Dette skyldes, at naloxon modvirker virkningerne af opioider, når det indsprøjtes, hvilket får patienten til at føle akutte abstinenssymptomer.
English: One main study compared Suboxone with buprenorphine on its own or with placebo (a dummy treatment) in 326 heroin-dependent patients for four weeks, and measured the percentage of patients who had no trace of opioids in their urine at the end of the study.
Danish: I en hovedundersøgelse blev Suboxone sammenlignet med buprenorphin alene eller med placebo (en uvirksom behandling) hos 326 heroinafhængige patienter i fire uger, og heri måltes procentandelen af patienter, som ikke havde spor af opioider i deres urin ved undersøgelsens afslutning.
English: What is the risk associated with Suboxone?
Danish: Hvilken risiko er der forbundet med Suboxone?
English: Why has Suboxone been approved?
Danish: Hvorfor blev Suboxone godkendt?
English: The full EPAR for Suboxone can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports For more information about treatment with Suboxone, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Den fuldstændige EPAR for Suboxone findes på agenturets websted ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is Suboxone?
Danish: Hvad er Suboxone?
English: How has Suboxone been studied?
Danish: Hvordan blev Suboxone undersøgt?
English: What is Suboxone used for?
Danish: Hvad anvendes Suboxone til?
English: What benefit has Suboxone shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Suboxone?
English: How is Suboxone used?
Danish: Hvordan anvendes Suboxone?
English: How does Suboxone work?
Danish: Hvordan virker Suboxone?
English: The marketing authorisation was renewed on 22 September 2003 and on 22 September 2008.
Danish: Markedsføringstilladelsen blev fornyet den 22. september 2003 og den 22. september 2008.
English: Other information about Comtan:
Danish: Andre oplysninger om Comtan:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Comtan to Novartis Europharm Limited on 22 September 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Comtan til Novartis Europharm Limited den 22. september 1998.
English: Comtan was more effective than placebo in both studies.
Danish: Comtan var mere effektivt end placebo i begge undersøgelser.
English: The patients then lose their ability to control their movements reliably.
Danish: Patienterne mister derved evnen til at styre sine bevægelser.
English: Comtan should not be used in patients with:
Danish: Comtan må ikke anvendes til patienter med:
English: The Committee recommended that Comtan be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Comtan.
English: The full EPAR for Comtan is available here.
Danish: Den fuldstændige EPAR for Comtan findes her.
English: It is taken as one tablet with each dose of the other medicine, up to a maximum of 10 tablets a day.
Danish: Der tages én tablet af Comtan sammen med hver dosis af den anden medicin, dog højst 10 tabletter dagligt.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) COMTAN EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) COMTAN EPAR - sammendrag for offentligheden
English: Comtan is a medicine that contains the active substance entacapone.
Danish: Comtan er et lægemiddel, der indeholder det aktive stof entakapon.
English: What is the risk associated with Comtan?
Danish: Hvilken risiko er der forbundet med Comtan?
English: The active substance in Comtan, entacapone, works to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Danish: Det aktive stof i Comtan, entakapon, genopretter indholdet af dopamin i de dele af hjernen, der styrer bevægelser og koordination.
English: Comtan is used to treat patients with Parkinson's disease.
Danish: Comtan anvendes til behandling af Parkinsons sygdom.
English: The most common side effects with Comtan (seen in between 1 and 10 patients in 100) are dyskinesia (uncontrollable movements), nausea (feeling sick) and harmless urine discoloration.
Danish: De almindeligste bivirkninger af Comtan (der ses hos mellem 1 og 10 patienter af hver 100) er frivillige bevægelser (dyskinesi), kvalme og (harmløs) farvning af urinen.
English: The main measure of effectiveness was the time spent in the ‘on' state (the time when levodopa is controlling the symptoms of Parkinson's disease) after the first levodopa dose of the morning in the first study, and over one day in the second study.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor længe patienterne blev i "on"-tilstand (dvs. den periode, hvor levodopa kontrollerer symptomerne på Parkinsons sygdom) efter den første dosis levodopa om morgenen i den første undersøgelse og i løbet af dagen i den anden undersøgelse.
English: When patients first add Comtan to their exiting medication, they may need to take a lower daily dose of levodopa, either by changing how often they take it, or by reducing the amount of levodopa taken in each dose.
Danish: Når patienterne første gang bruger Comtan som tillægsbehandling til den medicin, de får i forvejen, kan det være nødvendigt at mindske dagsdosis af levodopa, enten ved at ændre på, hvor ofte dosen tages eller ved at sætte dosen ned.
English: Comtan should not be used in people who may be hypersensitive (allergic) to entacapone or any of the other ingredients.
Danish: Comtan må ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for entakapon eller andre af indholdsstofferne.
English: Why has Comtan been approved?
Danish: Hvorfor blev Comtan godkendt?
English: What is Comtan?
Danish: Hvad er Comtan?
English: In the first study, adding Comtan increased the ‘on' time by 1 hour and 18 minutes more than adding placebo.
Danish: I den første undersøgelse gav tillægsbehandling med Comtan en "on"-periode, der var 1 time og 18 minutter længere end ved tillægsbehandling med placebo.
English: Comtan can only be used with conventional combinations of levodopa.
Danish: Comtan kan kun anvendes sammen med sædvanlige kombinationer af levodopa.
English: Comtan is used when these fluctuations cannot be treated with the standard levodopacontaining combination alone.
Danish: Anvendes, når fluktuationer ikke kan behandles alene med levodopa-standardkombinationen.
English: Comtan is only used in combination either with levodopa and benserazide or with levodopa and carbidopa.
Danish: Comtan anvendes kun i kombination med enten levodopa og benserazid eller levodopa og carbidopa.
English: Entacapone blocks an enzyme that is involved in the break down of levodopa in the body called catechol-O-methyl transferase (COMT).
Danish: Entakapon blokerer et enzym kaldet catechol-O-methyltransferase (COMT), som er med til at nedbryde levodopa i kroppen.
English: For the full list of all side effects reported with Comtan, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Comtan fremgår af indlægssedlen.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Comtan's benefits are greater than its risks as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Comtan opvejer risiciene som tillægsbehandling til sædvanlige præparater med levodopa/benserazid eller levodopa/carbidopa til patienter med Parkinsons sygdom og motoriske end-of-dose fluktuationer, når sygdommen ikke kan stabiliseres med sådanne kombinationsbehandlinger.
English: Comtan is used together with levodopa (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patient is having ‘fluctuations' towards the end of the period between two doses of their medication.
Danish: Comtan anvendes sammen med levodopa (en kombination enten af levodopa og benserazid eller af levodopa og carbidopa), når patienterne får 'fluktuationer' hen mod slutningen af perioden mellem to doser af medicinen.
English: It can be taken with or without food.
Danish: Lægemidlet kan indtages sammen med et måltid eller mellem måltiderne.
English: • a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Danish: • tidligere påvist malignt neuroleptikasyndrom (en farlig nervesygdom, sædvanligvis forårsaget af antipsykotiske lægemidler) eller rhabdomyolyse (nedbrydning af muskelfibrene) Comtan må ikke anvendes sammen med anden medicin, der tilhører gruppen af 'monoaminoxidasehæmmere' (et antidepressionsmiddel).
English: What is Comtan used for?
Danish: Hvad anvendes Comtan til?