FrancophonIA/ELRC3.0 huggingface dataset:
English: 224 capsules + 5 inhalers
Danish: Inhalationspulver, hårde kapsler 224 kapsler + 5 inhalatorer
English: How long to take TOBI Podhaler
Danish: Så længe tages TOBI Podhaler
English: If you take more TOBI Podhaler than you should
Danish: Hvis du har taget for meget TOBI Podhaler
English: Oropharnygeal pain
Danish: Misfarvet sputum
English: • Shortness of breath
Danish: Pibende vejrtrækning
English: Mylan EPD bvba/sprl Tél/Tel: +32 2 658 61 00
Danish: Tél/Tel: +32 2 658 61 00
English: • Replace the mouthpiece and screw it on firmly until it stops.
Danish: • Sæt mundstykket på igen, og skru det i bund.
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Replace the mouthpiece and screw it on firmly until it stops.
Danish: Sæt mundstykket på igen, og skru det i bund.
English: Throat irritation
Danish: Svælgirritation
English: If you have questions about how long to take TOBI Podhaler for, talk to your doctor or your pharmacist.
Danish: Tal med din læge eller apoteket, hvis du har spørgsmål til, hvor længe du skal tage TOBI Podhaler.
English: This summary was last updated in 03-2014.
Danish: Dette sammendrag blev senest ajourført i 03-2014.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Latuda on 21 March 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Latuda den 21. marts 2014.
English: This is a summary of the European public assessment report (EPAR) for Latuda.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Latuda.
English: Latuda lurasidone
Danish: Latuda lurasidon
English: Latuda has been investigated in six main studies.
Danish: Latuda har været genstand for seks hovedundersøgelser.
English: The recommended starting dose is 37 mg once a day, taken with food at approximately the same time of the day.
Danish: Den anbefalede startdosis er 37 mg én gang dagligt, der tages med et måltid til omtrent samme tid hver dag.
English: The full EPAR and risk management plan summary for Latuda can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og en sammenfatning af risikohåndteringsplanen for Latuda findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Latuda is available as tablets (18.5, 37 and 74 mg) and can only be obtained with a prescription.
Danish: Latuda leveres som tabletter (18,5, 37 og 74 mg) og udleveres kun på recept.
English: Depending on the patient's response and the judgement of the treating doctor, the dose can be increased up to a maximum dose of 148 mg once a day.
Danish: Afhængigt af behandlingens virkning og den behandlende læges skøn kan dosis øges til højst 148 mg én gang dagligt.
English: Other information about Latuda
Danish: Andre oplysninger om Latuda
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Latuda's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Latuda overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Latuda is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Latuda anvendes så risikofrit som muligt.
English: What measures are being taken to ensure the safe and effective use of Latuda?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Latuda?
English: Further analyses of the results were carried out by the company, which supported the short-term benefits of treatment with Latuda.
Danish: Virksomheden foretog yderligere analyser af resultaterne, hvilket støttede de kortsigtede fordele ved behandling med Latuda.
English: It attaches to and affects several different receptors for neurotransmitters on the surface of nerve cells in the brain.
Danish: Det bindes til forskellige typer receptorer for neurotransmittere på overfladen af nervecellerne i hjernen.
English: It is used to treat adults with schizophrenia, a mental illness that has a number of symptoms including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Danish: Det anvendes til behandling af voksne med skizofreni, en psykisk lidelse med symptomer i form af blandt andet desorganiseret tankegang og tale, hallucinationer (opfattelsen af at høre eller se ting, som ikke er der), mistænksomhed og vrangforestillinger (forestillinger, der er ude af trit med virkeligheden).
English: Why is Latuda approved?
Danish: Hvorfor er Latuda blevet godkendt?
English: Latuda is a medicine that contains the active substance lurasidone.
Danish: Latuda er et lægemiddel, der indeholder det aktive stof lurasidon.
English: The active substance in Latuda, lurasidone, is an antipsychotic medicine.
Danish: Det aktive stof i Latuda, lurasidon, er et antipsykotisk lægemiddel.
English: What is Latuda and what is it used for?
Danish: Hvad er Latuda, og hvad anvendes det til?
English: What are the risks associated with Latuda?
Danish: Hvilke risici er der forbundet med Latuda?
English: It is not intended to provide practical advice on how to use Latuda.
Danish: Det er ikke en praktisk vejledning i, hvordan Latuda bør anvendes.
English: The most common side effects with Latuda (which may affect more than 1 in 10 people) are akathisia (a constant urge to move) and somnolence (sleepiness).
Danish: De almindeligste bivirkninger med Latuda (som kan forekomme hos mere end 1 ud af hver 10 behandlede) er vedholdende trang til at bevæge sig (akatisi) og søvnighed.
English: In these studies, different doses of Latuda were shown to be more effective than placebo, lowering the PANSS score by up to 16 points more than placebo; however, this effect was not consistently demonstrated for each dose and it was not possible to observe a consistent dose-response relationship.
Danish: Undersøgelserne viste, at Latuda i forskellige doser var mere effektivt end placebo og sænkede PANSS-score med op til 16 point mere end placebo; denne virkning var dog ikke overensstemmende for hver dosis, og der kunne ikke iagttages en gennemgående sammenhæng mellem dosis og virkning.
English: While both shortand long-term effectiveness of Latuda have been sufficiently demonstrated, the CHMP noted that in the short-term studies its effectiveness was found to be moderate.
Danish: Skønt der er tilfredsstillende bevis for både den kortsigtede og langsigtede virkning af Latuda, bemærkede CHMP, at dets virkning i de kortvarige undersøgelser var fundet moderat.
English: Latuda must not be used together with medicines known as ‘strong CYP3A4 inhibitors' or ‘strong CYP3A4 inducers', which may affect the levels of lurasidone in the blood.
Danish: Latuda må ikke anvendes sammen med lægemidler, der er “stærke CYP3A4-hæmmere” eller “stærke CYP3A4-induktorer”, da de kan påvirke koncentrationen af lurasidon i blodet.
English: Lower doses should be used in patients with moderately or severely reduced kidney or liver function and in patients taking certain other medicines that may affect the levels of Latuda in the blood.
Danish: Dosis bør være lavere hos patienter med moderat eller svært nedsat nyre- eller leverfunktion og hos patienter, der får visse andre lægemidler, som kan påvirke koncentrationen af Latuda i blodet.
English: Regarding safety, the side effects of Latuda were considered similar to those of other medicines of the same type, but it seemed to have fewer effects on body metabolism (such as effects on blood levels of sugar and fat, and body weight) and might have less effect on the activity of the heart than some other available treatments.
Danish: Vedrørende sikkerheden fandtes bivirkningerne af Latuda at svare til andre lægemidlers af samme type, men det syntes at have mindre indvirkning på stofskiftet (såsom blodets sukker- og fedtstofindhold og legemsvægten), og måske har det også mindre indvirkning på hjerneaktiviteten end visse andre lægemidler på markedet.
English: Since dopamine, 5-hydroxytryptamine and noradrenaline play a role in schizophrenia, by blocking their receptors lurasidone helps to normalise the activity of the brain, reducing symptoms.
Danish: Da dopamin, 5-hydroxytryptamin og noradrenalin spiller en rolle ved skizofreni, kan lurasidon normalisere hjernens aktivitet, så symptomerne mindskes.
English: One of the short-term studies was continued to 12 months (extension study) to look at the maintenance of the effect of Latuda in 292 patients, compared with quetiapine; two other studies, involving 914 patients, looked at the long-term effects of Latuda compared with another schizophrenia medicine, risperidone, or placebo, respectively.
Danish: En af de kortvarige undersøgelser blev forlænget til 12 måneder for at se på opretholdelsen af virkningen af Latuda hos 292 patienter i sammenligning med quetiapin; to andre undersøgelser med 914 patienter vedrørte de langsigtede virkninger af Latuda i sammenligning med henholdsvis et andet skizofrenimiddel, risperidon, og placebo.
English: Lurasidone acts mainly by blocking the receptors for the neurotransmitters dopamine, 5hydroxytryptamine (also called serotonin) and noradrenaline.
Danish: Lurasidon menes hovedsagelig at virke på receptorerne for neurotransmitterne dopamin, 5-hydroxytryptamin (serotonin) og noradrenalin.
English: Three short-term studies compared Latuda with placebo (a dummy treatment) over six weeks in a total of 1,466 patients.
Danish: I tre korttidsundersøgelser blev Latuda sammenlignet med placebo (virkningsløs behandling) i en behandlingsperiode på 6 uger hos i alt 1 466 patienter.
English: The main measure of effectiveness was the change in the patient's symptoms, measured using a standard scale for schizophrenia called ‘positive and negative syndrome scale' (PANSS).
Danish: Virkningen blev hovedsagelig bedømt på ændringen i symptomerne bedømt på en standardskala for skizofreni ((PANSS, positive and negative syndrome scale).
English: For more information about treatment with Latuda, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Latuda, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Latuda, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for Latuda er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: The last study showed that 30% of patients treated with Latuda relapsed within one year, compared with 41% of patients treated with placebo.
Danish: I den sidste undersøgelse fik 30 % af de patienter, der blev behandlet med Latuda, tilbagefald inden for et år, sammenholdt med 41 % af dem, der blev behandlet med placebo.
English: In these long-term studies, the effectiveness of Latuda was measured by the percentage of patients who relapsed and had symptoms of schizophrenia coming back during treatment.
Danish: I disse langvarige undersøgelser blev virkningen af Latuda bedømt på den procentdel af patienterne, der fik tilbagefald med symptomer på skizofreni under behandlingen.
English: In the extension study, 21% of patients treated with Latuda had a relapse within one year, compared with 27% of patients treated with quetiapine, showing that Latuda was at least as effective as quetiapine.
Danish: I den forlængede undersøgelse fik 21 % af de patienter, der blev behandlet med Latuda, tilbagefald inden for et år, sammenholdt med 27 % af dem, der blev behandlet med quetiapin; Latuda var altså mindst lige så effektivt som quetiapin.
English: For practical information about using Latuda, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Latuda, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For the full list of all side effects reported with Latuda, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Latuda fremgår af indlægssedlen.
English: How is Latuda used?
Danish: Hvordan anvendes Latuda?
English: What benefits of Latuda have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Latuda?
English: Latuda was not shown to be as effective as risperidone in the second study, although the available data supported a long-term benefit.
Danish: I den anden undersøgelse var Latuda ikke lige så effektivt som risperidon, men dataene støttede, at Latuda var til gavn for patienterne på lang sigt.
English: How does Latuda work?
Danish: Hvordan virker Latuda ?
English: It is available as tablets (10, 20 and 100 mg).
Danish: Det fås som tabletter (10, 20 og 100 mg).
English: These results were maintained in the extension studies.
Danish: Disse resultater blev fastholdt i de forlængede undersøgelser.
English: Two of the studies lasted six months, and two lasted a year.
Danish: To af undersøgelserne varede seks måneder, og to af undersøgelserne varede et år.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Arava on 2 September 1999.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Arava den 2. september 1999.
English: Arava must not be used in patients with:
Danish: Arava må ikke anvendes til patienter med:
English: Arava leflunomide
Danish: Arava leflunomid
English: The full EPAR for Arava can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Arava findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Arava.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Arava.
English: The two longer studies were then extended, with patients remaining on the medicines for at least one more year.
Danish: De to længerevarende undersøgelser blev forlænget, så patienterne fortsatte behandlingen med lægemidlerne i mindst et år mere.
English: Other information about Arava
Danish: Andre oplysninger om Arava:
English: A risk management plan has been developed to ensure that Arava is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Arava anvendes så sikkert som muligt.
English: Arava was not as effective as methotrexate in the extension study.
Danish: Arava var ikke lige så effektivt som methotrexat i den forlængede undersøgelse.
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 Arava.
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 Arava.
English: Arava treatment usually starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Danish: Behandlingen med Arava indledes sædvanligvis med en startdosis på 100 mg en gang dagligt i tre dage efterfulgt af en vedligeholdelsesdosis.
English: They also need to take special care when switching a patient to Arava, or when switching a patient who is receiving Arava to another treatment.
Danish: De skal også være særligt omhyggelige, når en patient skifter til behandling med Arava, eller når en patient, der får Arava, skifter til en anden behandling.
English: Arava is a medicine that contains the active substance leflunomide.
Danish: Arava er et lægemiddel, der indeholder det aktive stof leflunomid.
English: For more information about treatment with Arava, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Arava, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Over the first year of treatment, Arava was as effective as methotrexate, but only when it was taken with folate (a type of vitamin B).
Danish: I det første behandlingsår var Arava lige så effektivt som methotrexat, men kun når det blev taget sammen med folat (en type B-vitamin).
English: What is the risk associated with Arava?
Danish: Hvilken risiko er der forbundet med Arava?
English: Between 49 and 55% of the patients taking Arava 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 Arava, responderede på behandlingen sammenlignet med 26 til 28 % af dem, der fik placebo, og 54 % af dem, der fik sulfasalazin.
English: Arava must not be used in pregnant women, in women who can become pregnant and who are not using reliable contraception, or during breastfeeding.
Danish: Arava må ikke anvendes til gravide kvinder, kvinder, som kan blive gravide og ikke bruger sikker antikontraception, eller kvinder, der ammer.
English: What measures are being taken to ensure the safe use of Arava?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Arava?
English: The most common side effects with Arava (seen in between 1 and 10 patients in 100) 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, diarrhoea, nausea (feeling sick), vomiting, inflammation of the mouth such as mouth ulcers, abdominal pain (stomach ache), 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 Arava (som optræder hos mellem 1 og 10 patienter ud af 100) er leukopeni (lavt leukocyttal), milde allergiske reaktioner, forhøjet kreatin phosphokinase (en markør for muskelskader), paræstesi (unormale fornemmelser som prikken og stikken), perifer neuropati (nervebeskadigelse i hænder og fødder), hovedpine, svimmelhed, let forhøjet blodtryk, diarré, kvalme, opkastning, betændelse i munden, f.eks. mundsår, mavesmerter, forhøjet antal leverenzymer, hårtab, eksem, udslæt, kløe, tør hud, tenosynovitis (seneskedehindebetændelse), appetitløshed, vægttab og asteni (slaphed).
English: The active substance in Arava, leflunomide, is an immunosuppressant.
Danish: Det aktive stof i Arava, leflunomid, er et immundæmpende stof.
English: Doctors prescribing Arava need to be aware of the risk of liver problems associated with the medicine.
Danish: Læger, der ordinerer Arava, skal være opmærksomme på risikoen for leverproblemer i tilknytning til lægemidlet.
English: The CHMP decided that Arava's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Arava opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Arava.
English: In psoriatic arthritis, Arava has been compared with placebo in 186 patients over six months.
Danish: Til arthritis psoriatica blev Arava sammenlignet med placebo hos 186 patienter over en periode på seks måneder.
English: In addition, the company that markets Arava will ensure that doctors who are expected to prescribe the medicine receive an information pack containing important information on the risks with Arava and the monitoring that should be carried out in patients.
Danish: Virksomheden, der markedsfører Arava, skal desuden sørge for, at læger, som forventes at ordinere lægemidlet, modtager en informationspakke med vigtige oplysninger om de risici, der er forbundet med brugen af Arava, og den patientovervågning, der skal foretages.
English: The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Arava, and regularly during treatment.
Danish: Lægen skal tage blodprøver for at kontrollere patientens lever, leukocyttal og trombocyttal, inden der ordineres Arava, og regelmæssigt under behandlingen.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Arava, 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 Arava, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Why has Arava been approved?
Danish: Hvorfor blev Arava godkendt?
English: Arava treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
Danish: Behandling med Arava må kun indledes og overvåges af en specialist med erfaring i behandling af rheumatoid arthritis og arthritis psoriatica.
English: In all of the studies, the main measure of effectiveness was the number of patients who responded to treatment, as defined by disease-specific criteria (American College of Rheumatology response rates for rheumatoid arthritis, and the Psoriatic Arthritis treatment Response Criteria for psoriatic arthritis).
Danish: I alle undersøgelserne var det primære effektmål antallet af patienter, der responderede på behandlingen, jf. de definerede sygdomsspecifikke kriterier (American College of Rheumatologys responsrater for rheumatoid arthritis og arthritis psoriatica-responskriterier ved behandling af arthritis psoriatica).
English: In rheumatoid arthritis, Arava was more effective than placebo and as effective as sulphasalazine.
Danish: Ved behandling af rheumatoid arthritis var Arava mere effektivt end placebo og lige så effektivt som sulfasalazin.
English: In psoriatic arthritis, Arava was more effective than placebo, with 59% of the patients taking Arava responding to treatment, compared with 30% of those taking placebo.
Danish: Ved behandling af arthritis psoriatica var Arava mere effektivt end placebo, idet 59 % af de patienter, der fik Arava, responderede på behandlingen sammenlignet med 30 % af de patienter, der fik placebo.
English: Arava must not be used in people who may be hypersensitive (allergic) to leflunomide, to teriflunomide (a breakdown product of leflunomide) or to any of the other ingredients.
Danish: Arava må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for leflunomid, teriflunomid (et spaltningsprodukt af leflunomid) eller andre af indholdsstofferne.
English: What is Arava?
Danish: Hvad er Arava?
English: Arava is 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: Arava anvendes til behandling af voksne med aktiv rheumatoid arthritis (en immunsygdom, der fremkalder inflammation (betændelse) i leddene) eller aktiv arthritis psoriatica (en sygdom, som fremkalder røde, afskallende pletter på huden og inflammation i leddene).