FrancophonIA/ELRC3.0 huggingface dataset:
English: Each NUEDEXTA 15 mg/9 mg capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 15.41 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
Danish: Hver kapsel NUEDEXTA, 15 mg/9 mg, indeholder dextromethorphanhydrobromidmonohydrat svarende til 15,41 mg dextromethorphan og kinidinsulfatdihydrat svarende til 8,69 mg kinidin.
English: Elderly patients
Danish: Særlige patientkategorier
English: BOTTLE CARTON (60 hard capsules) - NUEDEXTA 23 mg/9 mg capsules
Danish: FLASKEKARTON (60 kapsler, hårde) - NUEDEXTA, kapsler, 23 mg/9 mg
English: Concomitant use of NUEDEXTA and TCAs is not recommended (see section 4.4).
Danish: Samtidig anvendelse af NUEDEXTA og tricykliske antidepressiva frarådes (se pkt.
English: • abdominal pain, constipation, dry mouth, wind (flatulence), stomach discomfort, vomiting
Danish: • mavesmerter, forstoppelse, mundtørhed, tarmluft (flatulens), ubehag i maven, opkastning
English: • Drug misuse and abuse
Danish: • stofmisbrug
English: The first was a 4-week study in PBA subjects with underlying ALS, and the second was a 12-week study in subjects with underlying MS.
Danish: Den første var en 4-ugers undersøgelse hos patienter med PBA med underliggende ALS, mens den anden var en 12-ugers undersøgelse hos patienter med underliggende MS. I begge undersøgelser resulterede kombinationen dextromethorphan/kinidin i statistisk signifikant reduktion i det primære mål for udfald, CNS-LS, og i det sekundære mål for udfald, “antal episoder med latter og gråd”.
English: The effect of the combination on the patient's QTc interval should be evaluated with pre- and post-dose ECGs.
Danish: Før og efter dosering bør der tages EKG med henblik på virkningen af kombinationen på QTc-intervallet.
English: What NUEDEXTA is and what it is used for What you need to know before you take NUEDEXTA How to take NUEDEXTA
Danish: Det skal du vide, før du begynder at tage NUEDEXTA Sådan skal du tage NUEDEXTA Bivirkninger
English: Each capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 23.11 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
Danish: Hver kapsel indeholder dextromethorphanhydrobromidmonohydrat svarende til 23,11 mg dextromethorphan og kinidinsulfatdihydrat svarende til 8,69 mg kinidin.
English: If any of the above occur, stop taking the capsules and tell your doctor immediately
Danish: Hold op med at tage kapslerne og kontakt straks lægen, hvis du får nogen af ovenstående symptomer.
English: Each capsule contains dextromethorphan hydrobromide monohydrate, equivalent to 15.41 mg dextromethorphan and quinidine sulfate dihydrate, equivalent to 8.69 mg quinidine.
Danish: Hver kapsel indeholder dextromethorphanhydrobromidmonohydrat svarende til 15,41 mg dextromethorphan og kinidinsulfatdihydrat svarende til 8,69 mg kinidin.
English: A drug-drug interaction study was conducted between a higher combination dose of dextromethorphan/quinidine (dextromethorphan 23 mg/quinidine 26 mg) and memantine 20 mg/day.
Danish: I en lægemiddelinteraktionsundersøgelse blev en højere dosis af kombinationen (dextromethorphan 23 mg/kinidin 26 mg) anvendt sammen med memantin, 20 mg dagligt.
English: A drug-drug interaction study was conducted between a higher combination dose of dextromethorphan/quinidine (dextromethorphan 23 mg/quinidine 26 mg) and desipramine 25 mg.
Danish: Der er udført en lægemiddelinteraktionsundersøgelse med desipramin, 25 mg, og en højere dosis af kombinationen dextromethorphan/kinidin (dextromethorphan 23 mg/kinidin 26 mg).
English: BOTTLE CARTON (60 hard capsules) - NUEDEXTA 15 mg/9 mg capsules
Danish: FLASKEKARTON (60 kapsler, hårde) - NUEDEXTA, kapsler, 15 mg/9 mg
English: • NUEDEXTA 23 mg/9 mg is a brick red gelatin capsule, size 1, with “DMQ / 30-10” printed in white ink on the capsule and three white bands around the circumference.
Danish: • NUEDEXTA, 23 mg/9 mg, er rødbrune gelatinekapsler, størrelse 1, med påskriften “DMQ/30
English: In a drug-drug interaction study, a higher combination dose of dextromethorphan/quinidine (dextromethorphan 23 mg/quinidine 26 mg) was added to paroxetine at steady state.
Danish: I en lægemiddelinteraktionsundersøgelse blev paroxetin i steady state suppleret med kombinationen dextromethorphan/kinidin i en højere dosis (dextromethorphan 23 mg/kinidin 26 mg).
English: Printing ink
Danish: • muskeltrækninger
English: However, as there was a trend toward increased incidence of adverse reactions in patients with moderate hepatic impairment, additional monitoring of adverse reactions is advised in these patients.
Danish: Ekstra overvågning af bivirkninger hos sådanne patienter tilrådes.
English: Quinidine is excreted in human milk and it is unknown whether dextromethorphan is excreted in human milk.
Danish: Det vides ikke, om dextromethorphan udskilles i modermælk.
English: A 12 month open-label safety study, also using the higher dose combination of dextromethorphan 23 mg /quinidine 26 mg, included 553 subjects with PBA associated with thirty-four different neurological conditions.
Danish: I en 12-måneders åben sikkerhedsundersøgelse blev der også her anvendt den højere dosering af kombinationen dextromethorphan 23 mg/kinidin 26 mg.
English: • Abnormal faeces, Dyspepsia, Gastritis, Hypoaesthesia oral, Paraesthesia oral, Proctalgia, Tongue dry Hepatobiliary disorders Uncommon Increased hepatic enzymes (GGT, AST, ALT) Cholelithiasis, blood bilirubin increased, Liver function test
Danish: • Abnorme fæces, dyspepsi, gastritis, oral hypæstesi, oral paræstesi, proktalgi, tør tunge
English: Gastric lavage may be of use.
Danish: Maveskylning kan være hensigtsmæssig.
English: OTHER
Danish: Øjne
English: MAOIs
Danish: MAO-hæmmere
English: Other medicines and NUEDEXTA
Danish: amitriptylin og nefazodon
English: NUEDEXTA 15 mg/9 mg hard capsules
Danish: NUEDEXTA, kapsler, hårde, 15 mg/9 mg
English: flecainide and beta-blockers (such as metoprolol)
Danish: f.eks. phenelzin og moclobemid).
English: NUEDEXTA 23 mg/9 mg hard capsules
Danish: NUEDEXTA, kapsler, hårde, 23 mg/9 mg
English: Metabolism and nutrition disorders
Danish: Det reproduktive system og mammae
English: This authorisation was based on the authorisation granted to Arava in 1999 (‘informed consent').
Danish: Markedsføringstilladelsen var baseret på den tilladelse, som blev udstedt for Arava i 1999 ("informeret samtykke").
English: Two of the studies lasted 6 months, and two lasted 1 year.
Danish: To af studierne varede seks måneder, og to varede et år.
English: • serious infections;
Danish: • alvorlige infektioner
English: Leflunomide Zentiva received a marketing authorisation valid throughout the EU on 8 January 2010.
Danish: Leflunomide Zentiva fik en markedsføringstilladelse med gyldighed i hele EU den 8. januar 2010.
English: Leflunomide Zentiva must not be used in patients with:
Danish: Leflunomide Zentiva må ikke anvendes hos patienter med:
English: The two longer studies were then extended, with patients remaining on the medicines for at least 1 more year.
Danish: De to lange studier blev derefter forlænget, og patienterne fortsatte med lægemidlerne i mindst et år mere.
English: Further information on Leflunomide Zentiva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/leflunomide-zentiva.
Danish: Yderligere information om Leflunomide Zentiva findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/leflunomide-zentiva.
English: These results were maintained in the extension studies.
Danish: Disse resultater var de samme i de udvidede studier.
English: Leflunomide Zentiva1 (leflunomide)
Danish: Leflunomide Zentiva1 (leflunomid)
English: Leflunomide Zentiva is available as tablets (10 mg, 20 mg and 100 mg).
Danish: Leflunomide Zentiva fås som tabletter (10 mg, 20 mg og 100 mg).
English: 1 Previously known as Leflunomide Winthrop.
Danish: 1 Tidligere kaldet Leflunomide Winthrop.
English: • severe immunodeficiency states, such as acquired immune deficiency syndrome (AIDS);
Danish: • svære immundefekter såsom erhvervet immundefektsyndrom (aids)
English: As for all medicines, data on the use of Leflunomide Zentiva are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Leflunomide Zentiva løbende overvåget.
English: Leflunomide Zentiva was not as effective as methotrexate in the extension study.
Danish: Leflunomide Zentiva var ikke så effektivt som methotrexat i det udvidede studie.
English: The most common side effects with Leflunomide Zentiva (which may affect up to 1 in 10 people) are leucopenia (low white blood cell counts), mild allergic reactions, increased creatine phosphokinase levels (a marker of muscle damage), paraesthesia (abnormal sensations like pins and needles), peripheral neuropathy (nerve damage in hands and feet), headache, dizziness, mild increases in blood pressure, colitis (inflammation in the large bowel), diarrhoea, nausea (feeling sick), vomiting, inflammation of the mouth such as mouth ulcers, abdominal (belly) pain, increased liver enzyme levels, hair loss, eczema, rash, pruritus (itching), dry skin, tenosynovitis (inflammation of the sheath surrounding the tendons), loss of appetite, weight loss and asthenia (weakness).
Danish: De hyppigste bivirkninger ved Leflunomide Zentiva (som kan forekomme hos op til 1 ud af 10 personer) er leukopeni (lavt antal hvide blodlegemer), milde allergiske reaktioner, forhøjet kreatinfosfokinase (en markør for muskelskader), paræstesi (unormal prikkende og stikkende fornemmelse), perifer neuropati (nerveskader i hænder og fødder), hovedpine, svimmelhed, let forhøjet blodtryk, colitis (betændelse i tyktarmen), diarré, kvalme, opkast, betændelse i munden såsom mundsår, mavesmerter, forhøjet leverenzymtal, hårtab, eksem, udslæt, kløe, tør hud, tenosynovitis (betændelse i skeden omkring ledbåndene), appetitløshed, vægttab og svaghed (asteni).
English: Results showed that Leflunomide Zentiva was more effective than placebo and as effective as sulphasalazine.
Danish: Resultaterne viste, at Leflunomide Zentiva var mere effektivt end placebo og lige så effektivt som sulphaalazin.
English: Over the first year of treatment, Leflunomide Zentiva was as effective as methotrexate, but only when it was taken with folate (a type of vitamin B).
Danish: I løbet af det første behandlingsår var Leflunomide Zentiva lige så effektivt som methotrexat, men kun da det blev taget med folat (en type B-vitamin).
English: Leflunomide Zentiva treatment usually starts with a ‘loading dose' of 100 mg once a day for 3 days, followed by a maintenance dose.
Danish: Behandlingen med Leflunomide Zentiva starter normalt med en "støddosis" på 100 mg én gang dagligt i 3 dage efterfulgt af en vedligeholdelsesdosis.
English: For more information about using Leflunomide Zentiva, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Leflunomide Zentiva, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: They also need to take special care when switching a patient to Leflunomide Zentiva, or when switching a patient who is receiving Leflunomide Zentiva to another treatment.
Danish: De skal desuden være særligt påpasselige, når de skifter en patient til behandling med Leflunomide Zentiva, eller når de skifter en patient, der får Leflunomide Zentiva, til en anden behandling.
English: • moderate to severely impaired kidney function;
Danish: • moderat til svært nedsat nyrefunktion
English: The medicine usually starts to have an effect after 4 to 6 weeks.
Danish: Lægemidlets virkning begynder normalt at være synlig efter 4-6 uger, og virkningen kan forbedres yderligere i op til 6 måneder.
English: Other information about Leflunomide Zentiva
Danish: Andre oplysninger om Leflunomide Zentiva
English: With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.
Danish: Med færre lymfocytter er der mindre inflammation, hvorved symptomerne på artrit bedre kan holdes under kontrol.
English: Leflunomide does this by blocking an enzyme called ‘dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply.
Danish: Leflunomid gør dette ved at blokere et enzym kaldet "dihydroorotat dehydrogenase", der er nødvendigt for, at lymfocytterne kan formere sig.
English: • severe hypoproteinaemia (low blood protein levels).
Danish: • svær hypoproteinæmi (lavt proteinindhold i blodet).
English: The medicine contains the active substance leflunomide.
Danish: Lægemidlet indeholder det aktive stof leflunomid.
English: Between 49 and 55% of the patients taking Leflunomide Zentiva responded to treatment, compared with 26 to 28% of those taking placebo, and 54% of those taking sulphasalazine.
Danish: Mellem 49 og 55 % af de patienter, der fik Leflunomide Zentiva, responderede på behandlingen sammenlignet med 26-28 % af dem, der fik placebo, og 54 % af dem, der fik sulphaalazin.
English: Psoriatic arthritis
Danish: Psoriasisgigt
English: Leflunomide Zentiva must not be used in pregnant women, in women who can become pregnant and who are not using reliable contraception or during breast-feeding.
Danish: Leflunomide Zentiva må ikke anvendes til gravide, til kvinder i den fødedygtige alder, som ikke anvender sikker prævention, eller under amning.
English: The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Leflunomide Zentiva, and regularly during treatment.
Danish: Lægen bør tage blodprøver for at kontrollere patientens lever og antallet af hvide blodlegemer og blodplader, før Leflunomide Zentiva ordineres, og regelmæssigt under behandlingen.
English: The active substance in Leflunomide Zentiva, leflunomide, is an immunosuppressant.
Danish: Det aktive stof i Leflunomide Zentiva, leflunomid, er et immunundertrykkende lægemiddel.
English: An overview of Leflunomide Zentiva and why it is authorised in the EU
Danish: En oversigt over Leflunomide Zentiva, og hvorfor det er godkendt i EU
English: The European Medicines Agency decided that Leflunomide Zentiva's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Leflunomide Zentiva opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: It reduces inflammation by reducing the production of immune cells called ‘lymphocytes', which are responsible for inflammation.
Danish: Det mindsker betændelse ved at reducere produktionen af immunceller kaldet "lymfocytter", som er skyld i betændelse.
English: The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis.
Danish: Den anbefalede vedligeholdelsesdosis er 10 til 20 mg én gang dagligt hos patienter med leddegigt og 20 mg én gang dagligt hos patienter med psoriasisgigt.
English: Side effects reported with Leflunomide Zentiva are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Leflunomide Zentiva vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: What is Leflunomide Zentiva and what is it used for?
Danish: Hvad er Leflunomide Zentiva, og hvad anvendes det til?
English: In psoriatic arthritis, a study in 186 patients showed that Leflunomide Zentiva was more effective than placebo over 6 months: 59% of the patients taking Leflunomide Zentiva responded to treatment, compared with 30% of those taking placebo.
Danish: For psoriasisgigt viste en undersøgelse hos 186 patienter, at Leflunomide Zentiva var mere effektivt end placebo over seks måneder: 59 % af de patienter, der fik Leflunomide Zentiva, responderede på behandlingen sammenlignet med 30 % af dem, der fik placebo.
English: • poor bone marrow function or low blood cell counts (red cells, white cells or platelets) caused by conditions other than rheumatoid or psoriatic arthritis;
Danish: • dårlig knoglemarvsfunktion eller lavt antal blodceller (røde blodlegemer, hvide blodlegemer eller blodplader) forårsaget af andre tilstande end leddegigt eller psoriasisgigt
English: The company that markets Leflunomide Zentiva will ensure that doctors who are expected to prescribe the medicine receive an information pack containing important information on the risks with Leflunomide Zentiva and the monitoring that should be carried out in patients.
Danish: Virksomheden, der markedsfører Leflunomide Zentiva, skal sørge for, at læger, som forventes at ordinere lægemidlet, modtager en informationspakke med vigtig information om de risici, der er forbundet med Leflunomide Zentiva, og den patientovervågning, der bør finde sted.
English: What measures are being taken to ensure the safe and effective use of Leflunomide Zentiva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Leflunomide Zentiva?
English: It can only be obtained with a prescription and treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
Danish: Det udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en speciallæge med erfaring i behandling af leddegigt og psoriasisgigt.
English: Doctors prescribing Leflunomide Zentiva need to be aware of the risk of liver problems associated with the medicine.
Danish: Læger, der ordinerer Leflunomide Zentiva, skal være opmærksomme på risikoen for leverproblemer i forbindelse med lægemidlet.
English: • liver disease;
Danish: • leversygdom
English: Why is Leflunomide Zentiva authorised in the EU?
Danish: Hvorfor blev Leflunomide Zentiva godkendt i EU?
English: Leflunomide Zentiva is a medicine used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Danish: Leflunomide Zentiva er et lægemiddel til behandling af voksne med aktiv reumatoid artrit (leddegigt, en sygdom i immunsystemet, der forårsager betændelse i leddene) eller aktiv psoriasisartrit (psoriasisgigt, en sygdom, som forårsager rød, skællende hud og betændelse i leddene).
English: In rheumatoid arthritis, Leflunomide Zentiva has been studied in 4 main studies involving over 2,000 patients, in which it was compared with placebo (a dummy treatment), or with methotrexate or sulphasalazine (other medicines used to treat rheumatoid arthritis).
Danish: For leddegigt er Leflunomide Zentiva blevet undersøgt i fire hovedstudier med over 2.000 patienter, hvor det blev sammenlignet med placebo (en uvirksom behandling) eller med methotrexat eller sulphaalazin (andre lægemidler, der anvendes til behandling af leddegigt).
English: What are the risks associated with Leflunomide Zentiva?
Danish: Hvilken risiko er der forbundet med Leflunomide Zentiva?
English: For the full list of side effects with Leflunomide Zentiva, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Leflunomide Zentiva fremgår af indlægssedlen.
English: How is Leflunomide Zentiva used?
Danish: Hvordan anvendes Leflunomide Zentiva?
English: What benefits of Leflunomide Zentiva have been shown in the studies?
Danish: Hvilke fordele viser studierne, at der er ved Leflunomide Zentiva?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Leflunomide Zentiva have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Leflunomide Zentiva.
English: How does Leflunomide Zentiva work?
Danish: Hvordan virker Leflunomide Zentiva?
English: The tablets are swallowed whole with water.
Danish: Tabletterne synkes hele sammen med vand.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Champix on 26 September 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Champix den 26. september 2006.
English: The full EPAR for Champix can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Champix findes på agenturets websted på ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Champix.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Champix.
English: Champix varenicline
Danish: Champix vareniclin
English: It is available as tablets (0.5 and 1 mg).
Danish: Det leveres som tabletter (hvide: 0,5 mg og 1 mg).
English: A risk management plan has been developed to ensure that Champix is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Champix anvendes så sikkert som muligt.
English: The percentage in the patients who had taken bupropion was 16%.
Danish: Procentdelen blandt de patienter, der havde taget bupropion, var 16
English: Treatment with Champix lasts for 12 weeks.
Danish: Behandlingen med Champix varer 12 uger.
English: Champix is a medicine that contains the active substance varenicline.
Danish: Champix er et lægemiddel, der indeholder det aktive stof vareniclin.
English: Champix is used in adults to help them stop smoking.
Danish: Champix anvendes til voksne til at hjælpe dem med at holde op med at ryge.
English: In the first week the patient takes one 0.5 mg tablet once a day for three days, followed by one 0.5 mg tablet twice a day for four days.
Danish: I den første uge tager patienten en 0,5 mg-tablet en gang dagligt i tre dage, efterfulgt af en 0,5 mg-tablet to gange dagligt i fire dage.
English: For the remaining 11 weeks of treatment, the patient takes one 1 mg tablet twice a day.
Danish: I de resterende 11 uger af behandlingen tager patienten en 1 mg-tablet to gange dagligt.
English: For more information about treatment with Champix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Champix, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The main measure of effectiveness was the number of patients who had completely stopped smoking for four weeks (between week 9 and week 12 of the study), confirmed by laboratory testing of the patients' breath for signs of smoking.
Danish: Det vigtigste mål for virkningen var antallet af patienter, som helt var holdt op med at ryge i 4 uger (mellem uge 9 og uge 12 i forsøget), bekræftet af en laboratorieundersøgelse, hvor patienternes ånde blev undersøgt for tegn på rygning.
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 Champix.
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 Champix.
English: People who smoke become addicted to nicotine, a chemical in tobacco.
Danish: Mennesker, der ryger, bliver afhængige af nikotin, som er et kemikalie i tobakken.
English: The CHMP concluded that the benefits of Champix outweigh its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Champix opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: In both studies, Champix was more effective than bupropion or placebo in helping patients to stop smoking.
Danish: I begge undersøgelser var Champix mere effektivt end bupropion eller placebo til at hjælpe patienterne med at holde op med at ryge.