FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Gilenya and what is it used for?
Danish: Hvad er Gilenya, og hvad anvendes det til?
English: It must also ensure that all doctors who prescribe Gilenya receive an information pack containing important safety information, including a checklist of the risks with Gilenya and the situations where its use is not recommended.
Danish: Den skal ydermere sikre, at alle læger, som ordinerer Gilenya, modtager en informationspakke med vigtig sikkerhedsinformation, herunder en tjekliste med risiciene ved Gilenya og omstændighederne, hvor lægemidlet ikke bør anvendes.
English: The pack will also include information on a registry to collect data on babies born to women treated with Gilenya, as well as a patient reminder card for patients or their carers with key safety information.
Danish: Pakken vil også indeholde information om indregistrering med henblik på indsamling af data om spædbørn født af kvinder, der er i behandling med Gilenya, og et påmindelseskort til patienter eller deres plejere med vigtig sikkerhedsinformation.
English: Because Gilenya decreases the heart rate and can affect the heart's electrical activity and rhythm, the patient's blood pressure and heart activity is checked before starting treatment and during treatment, and also if Gilenya treatment is restarted after an interruption.
Danish: Da Gilenya nedsætter hjertefrekvensen og kan påvirke hjertets elektriske aktivitet og rytme, skal patientens blodtryk og hjerteaktivitet tjekkes før og under behandling samt ved genoptagelse af behandling med Gilenya efter en afbrydelse.
English: The checklist includes information on the tests and monitoring in patients before and during treatment with Gilenya.
Danish: Tjeklisten indeholder information om test- og overvågningsforløb hos patienter før og under behandling med Gilenya.
English: The European Medicines Agency concluded that there is clear evidence of the benefit of Gilenya in relapsing-remitting multiple sclerosis in both adults and children and noted that it had the benefit of being taken by mouth while most other medicines for this disease are given by injection.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Gilenya til behandling af recidiverende-remitterende multipel sklerose hos både voksne og børn er klart påvist, og bemærkede, at endnu en fordel er, at det skal tages gennem munden, mens de fleste andre lægemidler mod denne sygdom gives ved injektion.
English: Gilenya must also not be used in patients with certain diseases affecting the heart and blood vessels or in those who have had such diseases or problems with the blood supply to the brain.
Danish: Gilenya må heller ikke anvendes hos patienter med visse sygdomme, der påvirker hjertet og blodkarrene, eller hos patienter, der tidligere har haft sådanne sygdomme eller problemer med blodforsyningen til hjernen.
English: However, because of possible side effects, the Agency concluded that Gilenya should only be used in patients who have a real need for the medicine either because their disease has not improved with at least one other disease-modifying therapy or because it is severe and getting worse rapidly.
Danish: På grund af mulige bivirkninger konkluderede agenturet imidlertid, at Gilenya kun bør anvendes til patienter, som har et reelt behov for lægemidlet, enten fordi de ikke har fået det bedre efter mindst én anden sygdomsmodificerende behandling, eller fordi deres sygdom er svær og hurtigt forværres.
English: What are the risks associated with Gilenya?
Danish: Hvilke risici er der forbundet med Gilenya?
English: Details on the recommendations for monitoring patients are found in the summary of product characteristics.
Danish: Nærmere oplysninger om anbefalingerne vedrørende overvågning af patienter fremgår af produktresuméet.
English: Of patients given Gilenya, 14% (15 out of 107) experienced relapses compared with 54% (58 out of 107) of patients given interferon beta-1a.
Danish: Af de patienter, der fik Gilenya, oplevede 14 % (15 ud af 107) tilbagefald sammenlignet med 54 % (58 ud af 107) af de patienter, der fik interferon beta-1a.
English: The active substance in Gilenya, fingolimod, prevents T cells (a type of white blood cell involved in the immune system) travelling from the lymph nodes towards the brain and spinal cord, thus limiting the damage they cause in multiple sclerosis.
Danish: Det aktive stof i Gilenya, fingolimod, forhindrer Tceller (en type hvide blodlegemer, som er involveret i immunsystemet) i at bevæge sig fra lymfeknuderne mod hjernen og rygmarven og begrænser således den skade, de forårsager ved multipel sklerose.
English: Gilenya must not be used in patients at risk of infections due to a weakened immune system, patients with a severe infection or a long-term active infection such as hepatitis, and patients with cancer or severe liver problems.
Danish: Gilenya må ikke anvendes hos patienter med risiko for infektioner på grund af et svækket immunsystem, patienter med en svær infektion eller en langvarig aktiv infektion som f.eks. leverbetændelse, og patienter med kræft eller alvorlige leverproblemer.
English: Three main studies in adults and one main study in children have found that Gilenya was more effective than placebo (a dummy treatment) or interferon beta-1a (another medicine for treating multiple sclerosis) in patients with relapsing-remitting multiple sclerosis.
Danish: Det er i tre hovedstudier med voksne og i ét hovedstudie med børn påvist, at Gilenya var mere effektivt end placebo (en uvirksom behandling) eller interferon beta-1a (et andet lægemiddel til behandling af multipel sklerose) hos patienter med recidiverende-remitterende multipel sklerose.
English: In multiple sclerosis, the immune system (the body's defences) incorrectly attacks the protective sheath around the nerves in the brain and spinal cord.
Danish: Ved multipel sklerose angriber immunsystemet (kroppens naturlige forsvar) fejlagtigt den beskyttende skede omkring nerverne i hjernen og rygmarven.
English: The most serious side effects are infections, macular oedema (swelling in the central part of the retina at the back of the eye) and atrioventricular block (a type of heart rhythm disorder) at the start of treatment.
Danish: De alvorligste bivirkninger er infektioner, makulaødem (hævelse af den centrale del af nethinden bagest i øjet) og atrioventrikulært blok (en forstyrrelse af hjerterytmen) ved behandlingens start.
English: The most common side effects with Gilenya (seen in more than 1 patient in 10) are flu, sinusitis (inflammation of the sinuses), headache, cough, diarrhoea, back pain and raised liver enzyme levels (a sign of liver problems).
Danish: De hyppigste bivirkninger ved Gilenya (som optræder hos mere end 1 ud af 10 patienter) er influenza, sinusitis (bihulebetændelse), hovedpine, hoste, diarré, rygsmerter og øget niveau af leverenzymer (tegn på leverproblemer).
English: Gilenya is used when the disease remains active despite appropriate treatment with at least one other disease-modifying therapy, or is severe and getting worse rapidly.
Danish: Gilenya anvendes, når sygdommen fortsat er aktiv på trods af mindst en anden sygdomsmodificerende behandling, eller når sygdommen er svær og hurtigt forværres.
English: In two studies involving a total of 2,355 patients, Gilenya was compared with placebo over two years.
Danish: I to studier med i alt 2 355 patienter blev Gilenya sammenlignet med placebo over to år.
English: For the full list of side effects of Gilenya, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Gilenya fremgår af indlægssedlen.
English: Patients treated with Gilenya had around half the number of relapses compared with patients given placebo.
Danish: Patienter behandlet med Gilenya havde ca. halvt så mange tilbagefald som patienter behandlet med placebo.
English: How is Gilenya used?
Danish: Hvordan anvendes Gilenya?
English: In a study involving 215 children, Gilenya was compared with interferon beta-1a for up to 2 years.
Danish: I et studie med 215 børn blev Gilenya sammenlignet med interferon beta-1a i op til 2 år.
English: In a third study involving 1,292 patients, Gilenya was compared with interferon beta-1a over one year.
Danish: I et tredje studie med 1 292 patienter blev Gilenya sammenlignet med interferon beta-1a over et år.
English: What benefits of Gilenya have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Gilenya?
English: Gilenya is a type of medicine known as a ‘disease-modifying therapy' that is used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells.
Danish: Gilenya er en type lægemiddel, der kaldes "sygdomsmodificerende behandling", og som anvendes til behandling af voksne og af børn over 10 år med meget aktiv recidiverende-remitterende multipel sklerose.
English: Patients receiving Gilenya had around half the number of relapses compared with patients given interferon beta-1a.
Danish: Patienter, der fik Gilenya, havde ca. halvt så mange tilbagefald som patienter, der fik interferon beta1a.
English: How does Gilenya work?
Danish: Hvordan virker Gilenya?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gilenya 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 Gilenya.
English: The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Danish: Det sidste trin i gennemgangsproceduren er Europa-Kommissionens vedtagelse af en retligt bindende afgørelse med gyldighed i alle EU's medlemslande.
English: • Advise your patients about the signs and symptoms of liver injury.
Danish: • Oplys dine patienter om tegnene og symptomerne på leverskade.
English: Healthcare professionals prescribing Esmya in the EU will receive a letter with further details.
Danish: Sundhedspersoner, der ordinerer Esmya i EU, vil modtage et brev med nærmere oplysninger.
English: On 8 February 2018, while the review was ongoing, the PRAC issue temporary recommendations.
Danish: Den 8. februar 2018 fremsatte PRAC midlertidige anbefalinger, mens gennemgangen fandt sted.
English: All women taking Esmya should have a liver function test at least once a month during treatment.
Danish: Alle kvinder, der får Esmya, bør få taget en leverfunktionsprøve mindst én gang om måneden under behandlingen.
English: No new patients should start treatment for the time being
Danish: På nuværende tidspunkt bør der ikke sættes nye patienter i behandling
English: If the tests indicate that you have a liver problem, your treatment will be stopped.
Danish: Hvis prøverne viser, at du har et problem med leveren, vil du blive taget ud af behandlingen.
English: • If your treatment is stopped, your doctor will check how well your liver is working 2 to 4 weeks after you stop taking Esmya.
Danish: • Hvis du bliver taget ud af behandlingen, vil lægen kontrollere, hvor godt din lever fungerer, to til fire uger efter at du er holdt op med at tage Esmya.
English: • If you were about to start treatment with Esmya or start a new course of treatment, your doctor will put your treatment on hold until EMA's review of the medicine is complete.
Danish: • Hvis du skulle til at starte behandling med Esmya eller starte endnu et behandlingsforløb, vil lægen stille din behandling i bero, indtil EMA's gennemgang af lægemidlet er afsluttet.
English: Following reports of liver injury and hepatic failure with Esmya, EMA has made the following temporary recommendations:
Danish: Efter indberetninger om leverskade og leversvigt med Esmya har EMA fremsat følgende midlertidige anbefalinger:
English: • As a precaution, while taking Esmya you will be required to have blood tests to check that your liver is working well.
Danish: • Som en sikkerhedsforanstaltning skal du, mens du får Esmya, have taget blodprøver for at kontrollere, at din lever fungerer godt.
English: It is used for up to 3 months before women undergo surgery to remove the fibroids and can also be used long-term but with treatment breaks in other women.
Danish: Det anvendes i op til tre måneder, før kvinden får fjernet knuderne ved operation, og kan hos andre kvinder også anvendes i længere tid, dog med pauser i behandlingen.
English: • Perform liver function tests at least once a month for all patients taking Esmya.
Danish: • Tag leverfunktionsprøver mindst en gang om måneden hos alle patienter, der får Esmya.
English: The PRAC's final recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt an opinion.
Danish: PRAC's endelige anbefalinger vil blive fremsendt til Udvalget for Lægemidler til Mennesker (CHMP), der er ansvarligt for spørgsmål vedrørende lægemidler til mennesker, og som vil vedtage en udtalelse.
English: These recommendations are temporary measures to protect patients' health, pending the conclusion of the review of Esmya which started on 30 November 2017.
Danish: Disse anbefalinger er midlertidige foranstaltninger, der skal beskytte patienternes helbred, mens i afventning af konklusionen af gennemgangen af Esmya, der blev påbegyndt den 30. november 2017.
English: • If you have nausea (feeling sick), vomiting, upper belly pain, lack of appetite, tiredness or yellowing of the eyes or skin, contact your doctor immediately as these could be signs of liver problems.
Danish: • Hvis du får kvalme, opkastning, smerter i den øvre del af maven, appetitløshed, træthed eller gulfarvning af øjnene eller huden, skal du straks kontakte lægen, da det kan være tegn på leverproblemer.
English: EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is currently reviewing the benefits and risks with Esmya, following reports of serious liver injury, including liver failure leading to transplantation.
Danish: EMA's Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC) foretager for øjeblikket en gennemgang af fordelene og risiciene ved Esmya, efter at der er kommet indberetninger om alvorlig leverskade, herunder leversvigt, som har ført til transplantation.
English: • For any patient with signs or symptoms consistent with liver injury (such as nausea, vomiting, right hypochondrial pain, anorexia, asthenia, jaundice), check transaminase levels immediately.
Danish: • Ved tegn eller symptomer svarende til leverskade (såsom kvalme, opkastning, smerter i højre hypochondrium, anoreksi, asteni, gulsot) foretages straks bestemmelse af transaminaseværdier.
English: The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations.
Danish: Gennemgangen foretages af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC), som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som vil fremsætte et sæt anbefalinger.
English: Esmya was authorised in the EU in 2012 for the treatment of moderate to severe symptoms of uterine fibroids, which are non-cancerous (benign) tumours of the womb, in women who have not reached the menopause.
Danish: Esmya blev godkendt i EU i 2012 til behandling af moderate til svære symptomer på uterusfibromer, som er godartede svulster i livmoderen, hos kvinder, der ikke har nået overgangsalderen.
English: These recommendations are temporary measures, pending the conclusion of an ongoing EMA review of Esmya.
Danish: Disse anbefalinger er midlertidige foranstaltninger til anvendelse i afventning af konklusionen af EMA's igangværende gennemgang af Esmya.
English: A link between Esmya and cases of serious liver injury is under review.
Danish: Det er ved at blive vurderet, om der er sammenhæng mellem Esmya og tilfælde af alvorlig leverskade.
English: The active substance in Esmya, ulipristal acetate, works by attaching to the targets on cells (receptors) that the hormone progesterone normally attaches to, preventing progesterone from having its effect.
Danish: Det aktive stof i Esmya, ulipristalacetat, virker ved at bindes til målområderne (receptorerne) på de celler, som hormonet progesteron normalt bindes til.
English: Liver test should be repeated 2 to 4 weeks after stopping treatment.
Danish: Leverprøverne gentages to til fire uger efter behandlingens ophør.
English: The PRAC is also recommending that no new patients should be started on Esmya and no patients who have completed a course of treatment should start another one for the time being.
Danish: PRAC anbefaler desuden, at der ikke sættes nye patienter i behandling med Esmya, og at der på nuværende tidspunkt ikke påbegyndes endnu et behandlingsforløb for patienter, der allerede har gennemgået et behandlingsforløb.
English: Since progesterone may promote the growth of fibroids, by preventing the effects of progesterone ulipristal acetate reduces the size of the fibroids.
Danish: Da progesteron kan fremme væksten af knuder i livmoderen, mindsker ulipristalacetat størrelsen af knuderne ved at blokere virkningen af progesteron.
English: • Do not start new patients on Esmya or new treatment courses in patients who have already completed a previous one.
Danish: • Sæt ikke nye patienter i behandling med Esmya, og påbegynd ikke nye behandlingsforløb for patienter, der allerede har gennemgået et behandlingsforløb.
English: As a temporary measure while the review is ongoing, the PRAC has recommended regular liver monitoring for women taking Esmya for uterine fibroids.
Danish: Som en midlertidig foranstaltning under gennemgangen har PRAC anbefalet regelmæssig overvågning af leveren hos kvinder, der får Esmya mod knuder i livmoderen.
English: If the test is abnormal (liver enzyme levels more than 2 times the upper limit of normal), the healthcare professional should stop treatment and closely monitor the patient.
Danish: Hvis prøven giver unormalt resultat (leverenzymer højere end to gange den øvre grænse af normalområdet), bør behandlingen standses, og patienterne overvåges tæt.
English: If the patient develops transaminase levels more than 2 times the upper limit of normal, stop treatment and monitor the patient closely.
Danish: Hvis patientens transaminaseværdier bliver højere end to gange den øvre grænse af normalområdet, skal behandlingen standses, og patienten overvåges tæt.
English: If transaminase levels are more than 2 times the upper limit of normal, stop treatment and closely monitor the patient.
Danish: Ved transaminaseværdier højere end to gange den øvre grænse af normalområdet skal behandlingen seponeres, og patienten overvåges tæt.
English: • Esmya, used to treat uterine fibroids, is being reviewed because cases of serious liver problems have occurred in women taking the medicine.
Danish: • Esmya anvendes til behandling af knuder i livmoderen.
English: Olanzapine has been authorised in the European Union (EU) since 1996.
Danish: Olanzapin har været godkendt i Den Europæiske Union (EU) siden 1996.
English: The full EPAR for Zypadhera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zypadhera 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 Zypadhera.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zypadhera.
English: Zypadhera is given at doses of 150, 210 or 300 mg every two weeks, or 300 or 405 mg every four weeks.
Danish: Zypadhera gives i doser på 150, 210 eller 300 mg hver anden uge eller 300 eller 405 mg hver fjerde uge.
English: Zypadhera olanzapine
Danish: Zypadhera olanzapin
English: Zypadhera is not recommended for patients over 65 years of age.
Danish: Zypadhera anbefales ikke til patienter, der er ældre end 65 år.
English: Olanzapine attaches to several different receptors on the surface of nerve cells in the brain.
Danish: Olanzapin sætter sig på flere forskellige receptorer på overfladen af nervecellerne i hjernen.
English: Three of the doses of Zypadhera were ‘high' (300 mg and 150 mg every two weeks, and 405 mg every four weeks) and one was ‘low' (45 mg every four weeks).
Danish: Tre af Zypadhera-doserne var "høje" (300 mg og 150 mg hver anden uge samt 405 mg hver fjerde uge), og én var "lav" (45 mg hver fjerde uge).
English: The ‘high' doses of Zypadhera were more effective at preventing a worsening of symptoms than the ‘low' dose.
Danish: De "høje" doser Zypadhera var mere effektive til at forebygge en forværring af symptomerne end den "lave" dosis.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zypadhera on 19 November 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zypadhera den 19.11.08.
English: It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine.
Danish: Det menes, at olanzapins gavnlige effekt skyldes, at det blokerer receptorerne for neurotransmitterne 5-hydroxytrypamin (også kaldet serotonin) og dopamin.
English: ‘Prolonged release' means that the active substance is released slowly over a few weeks after being injected.
Danish: "Depotinjektion" betyder, at det aktive stof frigives langsomt i løbet af nogle få uger efter injektionen.
English: As a result, the active substance is released slowly for more than four weeks after injection of Zypadhera.
Danish: Det aktive stof frigøres derfor langsomt i løbet af mere end fire uger efter injektionen af Zypadhera.
English: Because olanzapine has already been authorised in the EU as Zyprexa, the company used some of the data from Zyprexa to support the use of Zypadhera.
Danish: Olanzapin er allerede godkendt i EU som Zyprexa, og virksomheden har derfor brugt nogle af dataene for Zyprexa til at understøtte brugen af Zypadhera.
English: For more information about treatment with Zypadhera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zypadhera, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: However, it noted that prolonged-release injections are not suitable for use as initial treatment, because the medicine takes at least a week to reduce symptoms and patients may need rapid control of symptoms.
Danish: Det konstaterede dog også, at depotinjektioner ikke er velegnede til indledende behandling, da lægemidlet er mindst en uge om at formindske symptomerne, og patienterne kan have behov for hurtig kontrol over symptomerne.
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 Zypadhera.
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 Zypadhera.
English: Symptoms of overdose include sedation (sleepiness) and delirium (confusion).
Danish: Symptomer på overdosis er bl.a. sløvhed og delirium (forvirring).
English: Since these neurotransmitters are involved in schizophrenia, olanzapine helps to normalise the activity of the brain, reducing the symptoms of the disease.
Danish: Disse neurotransmittere er aktive ved skizofreni, og olanzapin medvirker derfor til at normalisere hjerneaktiviteten, så symptomerne på sygdommen mindskes.