FrancophonIA/ELRC3.0 huggingface dataset:
English: However, long-term safety data are missing and these results alone are therefore not sufficient to support Olumiant use in previously untreated patients.
Danish: Der mangler dog langtidssikkerhedsdata, og derfor er disse resultater i sig selv ikke tilstrækkelige til at underbygge brugen af Olumiant hos tidligere ubehandlede patienter.
English: In one study involving 584 patients, Olumiant was more effective than methotrexate.
Danish: I et studie, der omfattede 584 patienter, var Olumiant mere effektivt end methotrexat.
English: Olumiant has also been studied in patients who had not received previous treatment.
Danish: Olumiant er også blevet undersøgt hos patienter, som ikke tidligere har modtaget behandling.
English: As for all medicines, data on the use of Olumiant is continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Olumiant løbende overvåget.
English: It works by blocking the action of enzymes known as Janus kinases.
Danish: Det virker ved at blokere aktiviteten af enzymer, der kaldes Janus-kinaser.
English: Overall, its side effects are considered manageable and several measures have been put in place to minimise the risks with this medicine, particularly infection.
Danish: Alt i alt betragtes lægemidlets bivirkninger som overskuelige, og der er truffet adskillige foranstaltninger for at minimere risiciene ved dette lægemiddel, navnlig infektion.
English: What measures are being taken to ensure the safe and effective use of Olumiant?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Olumiant?
English: For more information about using Olumiant, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Olumiant, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: By blocking the enzymes, baricitinib reduces the inflammation and other symptoms of the disease.
Danish: Ved at blokere enzymerne mindsker baricitinib betændelsen og andre symptomer på sygdommen.
English: What is Olumiant and what is it used for?
Danish: Hvad er Olumiant, og hvad anvendes det til?
English: Why is Olumiant authorised in the EU?
Danish: Hvorfor er Olumiant godkendt i EU?
English: The dose may also need to be reduced in patients who have impaired kidney function, who have an increased risk of infections and in those aged over 75 years or who are taking certain other medicines.
Danish: Det kan ligeledes være nødvendigt at nedsætte dosis hos patienter med nedsat nyrefunktion, patienter med øget risiko for infektioner og hos patienter over 75 år, eller hos patienter, der tager visse andre lægemidler.
English: Side effects reported with Olumiant are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Olumiant vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: An overview of Olumiant and why it is authorised in the EU
Danish: En oversigt over Olumiant, og hvorfor det er godkendt i EU
English: The European Medicines Agency decided that Olumiant'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 Olumiant opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Treatment with Olumiant must be started by a doctor who has experience in the diagnosis and treatment of rheumatoid arthritis.
Danish: Behandling med Olumiant skal indledes af en læge med erfaring i diagnosticering og behandling af rheumatoid arthritis.
English: The most common side effects with Olumiant used alone or in combination with methotrexate were increased blood cholesterol levels, nose and throat infections and nausea (which may affect 2 or more people in 100).
Danish: De hyppigste bivirkninger ved Olumiant anvendt alene eller i kombination med methotrexat var øgede kolesterolniveauer i blodet, næse- og halsinfektioner samt kvalme (som kan forekomme hos mere end 2 ud af 100 patienter).
English: The company that markets Olumiant will ensure that doctors who are expected to prescribe the medicine receive an information pack on the risks with Olumiant, particularly the risk of infection, and the monitoring that should be carried out in patients.
Danish: Virksomheden, der markedsfører Olumiant, skal sørge for, at læger, som forventes at ordinere lægemidlet, modtager en informationspakke om de risici, der er forbundet med brugen af Olumiant, navnlig infektionsrisikoen, og den patientovervågning, der skal foretages.
English: What are the risks associated with Olumiant?
Danish: Hvilke risici er der forbundet med Olumiant?
English: Infections reported with Olumiant treatment also included herpes zoster (shingles).
Danish: De infektioner, der blev indberettet ved behandling med Olumiant, omfattede også herpes zoster (helvedesild).
English: The active substance in Olumiant, baricitinib, is an immunosuppressant (a medicine that reduces the activity of the immune system).
Danish: Det aktive stof i Olumiant, baricitinib, er et immunundertrykkende lægemiddel (et lægemiddel, som undertrykker immunforsvarets aktivitet).
English: These enzymes play an important role in the process of inflammation and damage of the joints that occurs in rheumatoid arthritis.
Danish: Disse enzymer spiller en vigtig rolle i betændelsesprocessen og i den beskadigelse af leddene, der finder sted ved rheumatoid arthritis.
English: Three studies in around 2,500 patients showed that Olumiant improves symptoms, such as tenderness and joint swelling, in patients whose previous DMARDs have not worked well enough.
Danish: Tre studier hos ca. 2 500 patienter viste, at Olumiant forbedrer symptomer såsom ømhed og hævelse i leddene hos patienter, hvis tidligere sygdomsmodificerende antireumatiske lægemidler ikke har virket godt nok.
English: Olumiant is a medicine used for treating rheumatoid arthritis (a disease causing inflammation of the joints).
Danish: Olumiant er et lægemiddel, der anvendes til behandling af rheumatoid arthritis (en sygdom, som forårsager betændelse i leddene).
English: In terms of safety, being an oral treatment means that Olumiant does not have the same risks as other DMARDs given by injection such as allergic reactions related to the way the medicine is given.
Danish: Hvad sikkerheden angår, betyder dét, at Olumiant er en behandling, der tages gennem munden, at lægemidlet ikke har de samme risici som andre sygdomsmodificerende antireumatiske lægemidler, der gives ved injektion, såsom allergiske reaktioner, der er forbundet med lægemidlets indgivelsesmåde.
English: In these studies, Olumiant (alone or with the DMARD methotrexate) resulted in more patients achieving an improvement of 20% or more in a standard symptom score (ACR 20) than comparator medicines and placebo.
Danish: I disse studier medførte Olumiant (alene eller sammen med det sygdomsmodificerende antireumatiske lægemiddel methotrexat), at flere patienter opnåede en forbedring på mindst 20 % i en standardsymptomscore (ACR 20) end sammenligningslægemidler og placebo.
English: For the full list of side effects reported with Olumiant, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Olumiant fremgår af indlægssedlen.
English: How is Olumiant used?
Danish: Hvordan anvendes Olumiant?
English: It is used in patients with moderate to severe arthritis when standard treatment with disease-modifying anti-rheumatic drugs (also known as ‘DMARDs') has not worked well enough or if patients cannot tolerate them.
Danish: Det anvendes til patienter med moderat til svær arthritis, hvis standardbehandling med sygdomsmodificerende antireumatiske lægemidler (også kendt som "DMARD'er") ikke har virket godt nok, eller hvis patienterne ikke kan tåle dem. Olumiant kan anvendes enten alene eller i kombination med det sygdomsmodificerende antireumatiske lægemiddel methotrexat.
English: What benefits of Olumiant have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Olumiant?
English: • In patients previously treated with a class of DMARDs called TNF-inhibitors, 55% of patients (98 out of 177) on Olumiant achieved at least a 20% improvement, compared with 27% of patients (48 out of 176) on placebo.
Danish: • Hos patienter, der tidligere er behandlet med en sygdomsmodificerende antireumatisk lægemiddelklasse, som kaldes TNF-hæmmere, opnåede 55 % (98 ud af 177) af de patienter, der fik Olumiant, en forbedring på mindst 20 % sammenlignet med 27 % (48 ud af 176) af de patienter, der fik placebo.
English: • In patients previously treated with methotrexate, 70% of patients (339 out of 487) on Olumiant achieved at least a 20% improvement in symptom scores, compared with 61% of patients (202 out of 330) on adalimumab (another DMARD) and 40% (196 out of 488 patients) on placebo.
Danish: • Hos patienter, der tidligere er behandlet med methotrexat, opnåede 70 % (339 ud af 487) af de patienter, der fik Olumiant, en forbedring på mindst 20 % i deres symptomscorer sammenlignet med 61 % (202 ud af 330) af de patienter, der fik adalimumab (et andet antireumatisk lægemiddel), og 40 % (196 ud af 488) af de patienter, der fik placebo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Olumiant 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 Olumiant.
English: • In patients previously treated with conventional DMARDs, 62% of patients (140 out of 227) on Olumiant achieved at least a 20% improvement, compared with 40% of patients (90 out of 228) on placebo.
Danish: • Hos patienter, der tidligere er behandlet med konventionelle sygdomsmodificerende antireumatiske lægemidler, opnåede 62 % (140 ud af 227) af de patienter, der fik Olumiant, en forbedring på mindst 20 % sammenlignet med 40 % (90 ud af 228) af de patienter, der fik placebo.
English: The Agency considered that Olumiant was shown to be effective at improving symptoms of rheumatoid arthritis in patients when previous treatment with DMARDs has not worked well enough or if patients cannot tolerate them.
Danish: Agenturet var af den opfattelse, at det var påvist, at Olumiant var effektivt til at forbedre symptomerne på rheumatoid arthritis hos patienter, hvis tidligere behandling med sygdomsmodificerende antireumatiske lægemidler ikke har virket godt nok, eller hvis patienterne ikke kan tåle dem. Agenturet tog ligeledes højde for de manglende behandlingsmuligheder for disse patienter, og at Olumiants indgivelse gennem munden er bekvem for patienterne.
English: How does Olumiant work?
Danish: Hvordan virker Olumiant?
English: EMA/CHMP/138741/2015 EMEA/H/C/000563
Danish: EMA/101950/2015 EMEA/H/C/000563
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aloxi on 22 March 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Aloxi den 22. marts 2005.
English: The full EPAR for Aloxi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Aloxi findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Aloxi.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Aloxi.
English: A risk management plan has been developed to ensure that Aloxi is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Aloxi anvendes så sikkert som muligt.
English: Aloxi is a medicine that contains the active substance palonosetron.
Danish: Aloxi er et lægemiddel, der indeholder det aktive stof palonosetron.
English: The active substance in Aloxi, palonosetron, is a ‘5HT3 antagonist'.
Danish: Det aktive stof i Aloxi, palonosetron, er en ‘5HT3-antagonist'.
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 Aloxi.
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 Aloxi.
English: This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut.
Danish: Det betyder, at det forhindrer et kemisk stof i kroppen kaldet 5-hydroxytryptamin (5HT, også kendt som serotonin) i at binde sig til 5HT3receptorer i tarmene.
English: All of the studies measured the number of patients who did not vomit after receiving chemotherapy.
Danish: I alle undersøgelserne måltes antallet af patienter, som ikke kastede op efter at have fået kemoterapien.
English: Other information about Aloxi
Danish: Andre oplysninger om Aloxi
English: The most common side effect with Aloxi (seen in between 1 and 10 patients in 100) is headache.
Danish: Den hyppigste bivirkning ved Aloxi (som optræder hos mellem 1 og 10 patienter ud af 100) er hovedpine.
English: For more information about treatment with Aloxi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Aloxi, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of Aloxi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Aloxi?
English: Aloxi, given at two different doses, was compared with ondansetron and dolasetron (other medicines of the same type).
Danish: Aloxi blev i to forskellige doser sammenlignet med ondansetron og dolasetron (andre lægemidler af samme type).
English: The CHMP decided that the benefits of Aloxi are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Aloxi opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: It may be made more effective by the addition of a corticosteroid (a type of medicine that can be used to prevent nausea and vomiting).
Danish: Effekten kan forstærkes ved at tilføje et kortikosteroid (en type lægemiddel, der kan anvendes til at forebygge kvalme og opkastninger).
English: When 5HT attaches to these receptors, it normally causes nausea and vomiting.
Danish: Når 5HT binder sig til disse receptorer, forårsager dette normalt kvalme og opkastninger.
English: With the solution for injection, dizziness, constipation and diarrhoea are also seen in between 1 and 10 adults in 100.
Danish: I forbindelse med injektionsvæsken ses ligeledes svimmelhed, forstoppelse og diarré hos mellem 1 og 10 voksne ud af 100.
English: Aloxi should only be given before chemotherapy.
Danish: Aloxi skal kun gives inden kemoterapi.
English: In adults, if the capsules are used, the patient should take one capsule one hour before the start of chemotherapy.
Danish: Hvis kapslerne anvendes til voksne, skal patienten tage en kapsel en time inden påbegyndelse af kemoterapien.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aloxi, 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 Aloxi, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: In the study looking at Aloxi capsules, all three doses of Aloxi were as effective as the solution for injection over 24 hours, with around three-quarters of the patients not vomiting.
Danish: I undersøgelsen af Aloxi kapsler var alle tre doser af Aloxi lige så effektive som injektionsvæsken i 24 timer, hvor ca. tre fjerdedele af patienterne ikke kastede op.
English: The solution for injection should be given by a healthcare professional about 30 minutes before the start of chemotherapy.
Danish: Opløsningen til injektion skal gives af sundhedspersonale ca. 30 minutter før kemoterapien startes.
English: However, only the 500 microgram dose remained as effective as the solution for injection over the first five days after chemotherapy: around 59% of the patients receiving the 500 microgram capsule or the injection did not vomit during this period.
Danish: Imidlertid var det kun dosis på 500 mikrogram, der var lige så effektiv som injektionsvæsken i de første fem dage efter kemoterapi: Ca. 59 % af de patienter, som fik kapslen på 500 mikrogram eller injektionen, kastede ikke op i denne periode.
English: It is available as a solution for injection (250 micrograms in 5 ml) and as capsules (500 micrograms).
Danish: Det fås som en injektionsvæske, opløsning (250 mikrogram i 5 ml), og som kapsler (500 mikrogram).
English: By blocking these receptors, Aloxi prevents the nausea and vomiting that often happen after chemotherapy.
Danish: Ved at blokere disse receptorer forebygger Aloxi den kvalme og de opkastninger, som ofte indtræder efter kemoterapi.
English: For the full list of all side effects and restrictions with Aloxi, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger ved Aloxi fremgår af indlægssedlen.
English: When it was compared with dolasetron, these values were 63% for Aloxi (119 patients out of 189) and 53% for dolasetron (101 patients out of
Danish: Ved sammenligning med dolasetron var disse værdier 63 % for Aloxi (119 patienter ud af 189) og 53 % for dolasetron (101 patienter ud af 191).
English: Aloxi solution for injection was as effective as the comparator medicines.
Danish: Aloxi injektionsvæske, opløsning, var lige så effektivt som sammenligningspræparaterne.
English: Aloxi is used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer).
Danish: Aloxi anvendes til forebyggelse af kvalme og opkastninger forårsaget af kemoterapi (lægemidler til behandling af kræft).
English: The solution for injection is used in adults and children 1 month of age or older for chemotherapy with medicines that are either a strong trigger of nausea and vomiting (such as cisplatin) or a moderate trigger (such as cyclophosphamide, doxorubicin or carboplatin).
Danish: Injektionsvæsken, opløsning, anvendes til voksne og børn fra 1 måned og opad til kemoterapi med lægemidler, som enten i kraftig grad udløser kvalme og opkastninger (såsom cisplatin), eller som i moderat grad udløser kvalme og opkastninger (såsom cyclophosphamid, doxorubicin eller carboplatin).
English: In children, the solution should be given by infusion (drip) into a vein over 15 minutes at a dose of 20 micrograms per kilogram body weight.
Danish: Hos børn skal opløsningen gives ved infusion (drop) i en vene over 15 minutter i en dosis på 20 mikrogram/kg kropsvægt.
English: The capsules are only used in adults for chemotherapy that is a moderate trigger of nausea and vomiting in adults.
Danish: Kapslerne anvendes kun til voksne til kemoterapi, som i moderat grad udløser kvalme og opkastninger hos voksne.
English: A further study compared three doses of Aloxi capsules (250, 500 and 750 micrograms) with the solution for injection in 651 adults receiving chemotherapy that was a moderate trigger of nausea and vomiting.
Danish: I en yderligere undersøgelse blev tre doser af Aloxi kapsler (250, 500 og 750 mikrogram) sammenlignet med injektionsvæsken hos 651 voksne, der fik kemoterapi, som i moderat grad udløste kvalme og opkastninger.
English: Why has Aloxi been approved?
Danish: Hvorfor blev Aloxi godkendt?
English: What is the risk associated with Aloxi?
Danish: Hvilken risiko er der forbundet med Aloxi?
English: In adults, the solution should be injected into a vein over 30 seconds at a dose of 250 micrograms.
Danish: Hos voksne gives opløsningen i en dosis på 250 mikrogram i en vene over 30 sekunder.
English: What is Aloxi?
Danish: Hvad er Aloxi?
English: Aloxi solution for injection has been studied in three main studies involving 1,842 adults receiving chemotherapy that was a strong or a moderate trigger of nausea and vomiting.
Danish: Aloxi injektionsvæske, opløsning, blev undersøgt i tre hovedundersøgelser hos 1 842 voksne, der fik kemoterapi, som i kraftig eller moderat grad udløste kvalme og opkastninger.
English: In the study in children receiving chemotherapy that was a strong or moderate trigger of nausea and vomiting, 59% of the children receiving Aloxi solution for injection at a dose of 20 micrograms/kilogram did not vomit in the 24 hours after chemotherapy (98 out of 165), which was the same percentage as seen in patients receiving ondansetron (95 out of 162).
Danish: I undersøgelsen hos børn, der fik kemoterapi, som i kraftig eller moderat grad udløste kvalme og opkastninger, kastede 59 % af de børn, som fik Aloxi injektionsvæske, opløsning, i en dosis på 20 mg/kg kropsvægt, ikke op i de 24 timer, der fulgte efter kemoterapien (98 ud af 165), hvilket var den samme procentdel som hos patienter, der fik ondansetron (95 ud af 162).
English: With chemotherapy that was a strong trigger of nausea and vomiting, 59% of the adults receiving Aloxi did not vomit in the 24 hours after chemotherapy (132 out of 223), compared with 57% of the patients receiving ondansetron (126 out of 221).
Danish: Ved kemoterapi, som i kraftig grad udløste kvalme og opkastninger, havde 59 % af de voksne, som fik Aloxi, ingen opkastninger i de 24 timer, som fulgte efter kemoterapien (132 ud af 223), sammenlignet med 57 % af de patienter, der fik ondansetron (126 ud af 221).
English: How has Aloxi been studied?
Danish: Hvordan blev Aloxi undersøgt?
English: What is Aloxi used for?
Danish: Hvad anvendes Aloxi til?
English: With chemotherapy that was a moderate trigger of nausea and vomiting, 81% of the adults receiving Aloxi did not vomit in the 24 hours after chemotherapy (153 out of 189) compared with 69% of those receiving ondansetron (127 out of 185).
Danish: Ved kemoterapi, som i moderat grad udløste kvalme og opkastninger, havde 81 % af de voksne, der fik Aloxi, ingen opkastninger i de 24 timer, der fulgte efter kemoterapien (153 ud af 189), sammenlignet med 69 % af dem, der fik ondansetron (127 ud af 185).
English: What benefit has Aloxi shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Aloxi?
English: How is Aloxi used?
Danish: Hvordan anvendes Aloxi?
English: Aloxi solution for injection has also been investigated in one study involving 502 children receiving chemotherapy that was a strong or a moderate trigger of nausea and vomiting, where Aloxi was compared with ondansetron.
Danish: Aloxi injektionsvæske, opløsning, blev desuden undersøgt i en undersøgelse med 502 børn og voksne, der fik kemoterapi, som i kraftig eller moderat grad udløste kvalme og opkastninger.
English: How does Aloxi work?
Danish: Hvordan virker Aloxi?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fluenz on 27 January 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Fluenz den 27. januar 2011.
English: This will help to protect against the disease caused by the virus.
Danish: Dette medvirker til at beskytte mod den sygdom, som virussen forårsager.
English: Fluenz is a vaccine.
Danish: Fluenz er en vaccine.
English: This is a summary of the European public assessment report (EPAR) for Fluenz.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Fluenz.