FrancophonIA/ELRC3.0 huggingface dataset:
English: In studies of Trudexa, the most common side effects (seen in more than 1 patient in 10) were upper respiratory infection (colds) and injection site reactions (including pain, swelling, redness or pruritus [itching]).
Danish: I undersøgelserne med Trudexa var de hyppigste bivirkninger (der sås hos mere end 1 af hver 10 patienter) øvre luftvejsinfektioner (forkølelse) og reaktioner på injektionsstedet (smerte, hævelse, rødme eller kløe).
English: The medicines were taken alone or in combination with another anti-inflammatory medicine such as methotrexate.
Danish: Lægemidlerne blev dels taget alene, dels i kombination med andre antiinflammatoriske lægemidler, f.eks. methotrexat.
English: What is the risk associated with Trudexa?
Danish: Hvilken risiko er der forbundet med Trudexa?
English: Trudexa should not be used in patients with tuberculosis, other severe infections, or moderate or severe heart failure.
Danish: Trudexa bør ikke anvendes hos patienter med tuberkulose, andre svære infektioner eller moderat til svært hjertesvigt.
English: It is available as a solution for injection in a vial, pre-filled syringe or pre-filled pen, all containing 40 mg of adalimumab.
Danish: Det leveres som injektionsvæske, opløsning, i hætteglas, fyldte sprøjter og fyldte injektionspenne, der alle indeholder 40 mg adalimumab.
English: The Committee for Medicinal products for Human Use (CHMP) decided that Trudexa's benefits are greater than its risks for treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in adults when other treatments have been inadequate.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Trudexa opvejer risiciene til behandling af moderat til svær leddegigt, psoriasisgigt og ankyloserende spondylitis hos voksne, når andre midler ikke har virket tilfredsstillende.
English: After training, patients may inject themselves with Trudexa if their doctor agrees.
Danish: Efter oplæring kan patienten selv foretage indsprøjtningen med Trudexa, hvis det godkendes af lægen.
English: Why has Trudexa been approved?
Danish: Hvorfor blev Trudexa godkendt?
English: Trudexa should not be used in people who may be hypersensitive (allergic) to adalimumab or any of the other ingredients.
Danish: Trudexa bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for adalimumab eller andre af indholdsstofferne.
English: For the other two diseases, Trudexa produced a greater improvement in symptoms than placebo.
Danish: For de to andre sygdommes vedkommende gav Trudexa større symptomlindring end placebo.
English: Adalimumab has been designed to bind to a chemical messenger in the body called tumour necrosis factor (TNF).
Danish: Adalimumab er opbygget, så det bindes til et af kroppens kemiske signalstoffer, der kaldes tumornekrosefaktor (TNF).
English: The greatest reductions were seen in the studies examining Trudexa as an add-on to methotrexate: in the two studies taken together, around two thirds of the patients adding 40 mg Trudexa every 2 weeks had at least a 20% reduction in symptoms after 6 months, compared to a quarter of those adding placebo.
Danish: Den største symptomlindring opnåedes i de undersøgelser, hvor Trudexa blev anvendt som tillægsbehandling til methotrexat: I de to undersøgelser sammenlagt fik ca. to tredjedele af de patienter, der fik 40 mg Trudexa som tillægsbehandling hver anden uge, en symptomlindring på mindst 20 % efter 6 måneder.
English: Trudexa has been studied in five studies including almost 2,900 patients with moderate to severe rheumatoid arthritis.
Danish: Trudexa var genstand for fem undersøgelser, der omfattede næsten 2 900 patienter med moderat til svær leddegigt.
English: In all five studies, the main measure of effectiveness was the change in symptoms after 6 months to a year of treatment.
Danish: I alle fem undersøgelser blev behandlingens virkning hovedsagelig bedømt på ændringen i symptomer efter 6 til 12 måneders behandling.
English: The active substance in Trudexa, adalimumab, is a monoclonal antibody.
Danish: Adalimumab, det aktive stof i Trudexa, er et monoklonalt antistof.
English: In the patients who had not taken methotrexate before, more patients taking Trudexa and methotrexate had a 50% reduction in symptoms than those taking methotrexate alone over a year of treatment (62% and 46%, respectively).
Danish: Af dem, der ikke tidligere havde fået methotrexat, var der flere, der på ét år opnåede 50 % færre symptomer med Trudexa plus methotrexat, end med methotrexat alene (hhv. 62 % og 46 %).
English: In four of these studies (involving over 2,000 patients), the effectiveness of Trudexa, alone or as an as add-on to other anti-inflammatory medicines, including methotrexate, was compared with that of a placebo (a dummy treatment) in patients who generally had taken anti-arthritis medicines in the past.
Danish: I fire af undersøgelserne (med over 2 000 patienter) blev Trudexa, enten alene eller som tillægsbehandling til anden medicin, herunder methotrexat, sammenlignet med placebo (virkningsløs behandling) hos patienter, der for størstedelen tidligere havde fået gigtmidler.
English: In rheumatoid arthritis, Trudexa has been shown to reduce the rate at which joint damage gets worse and to improve physical function, when given in combination with methotrexate.
Danish: Trudexa er ved leddegigt påvist at hæmme forværringen af ledskader og forbedre den fysiske funktion, når det gives i kombination med methotrexat.
English: For the full list of all side effects reported with Trudexa, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Trudexa fremgår af indlægssedlen.
English: What is Trudexa?
Danish: Hvad er Trudexa?
English: What is Trudexa used for?
Danish: Hvad anvendes Trudexa til?
English: Patients adding Trudexa also had less joint damage and experienced less reduction in physical function than those adding placebo after a year of treatment.
Danish: Efter et års behandling havde de patienter, der fik Trudexa som tillægsbehandling, færre ledskader og mindre forringelse af den fysiske funktion end dem, der fik placebo.
English: • rheumatoid arthritis (an immune system disease causing inflammation of the joints).
Danish: • Leddegigt (en sygdom i immunsystemet, der medfører betændelse (inflammation) i leddene).
English: In rheumatoid arthritis, Trudexa was more effective than placebo in reducing symptoms.
Danish: Trudexa var mere effektivt end placebo til at lindre symptomerne på leddegigt.
English: For psoriatic arthritis, Trudexa was compared to placebo in two studies including 413 patients.
Danish: Til behandling af psoriasisgigt blev Trudexa sammenlignet med placebo (virkningsløs behandling) i to undersøgelser med 413 patienter.
English: • severe ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine) in patients who have not responded adequately to other treatments.
Danish: • Svær ankyloserende spondylitis (Bekhterevs sygdom, en sygdom, der medfører ledbetændelse og ledsmerter i rygsøjlen), hvor anden behandling ikke har virket tilfredsstillende.
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) in patients who have not responded adequately to other treatments,
Danish: • Psoriasisgigt (en sygdom, der giver rød, skællende hud og ledbetændelse) hvor anden behandling ikke har virket tilfredsstillende.
English: What benefit has Trudexa shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Trudexa?
English: How has Trudexa been studied?
Danish: Hvordan blev Trudexa undersøgt?
English: How is Trudexa used?
Danish: Hvordan anvendes Trudexa?
English: The fifth study included 799 patients, none of whom had taken methotrexate in the past, and compared the combination of Trudexa and methotrexate to methotrexate or Trudexa alone.
Danish: Den femte undersøgelse omfattede 799 patienter, der ikke tidligere havde fået methotrexat.
English: How does Trudexa work?
Danish: Hvordan virker Trudexa?
English: and is found at high levels in patients with the diseases that Trudexa is used to treat.
Danish: Dette signalstof er en medvirkende årsag til betændelsestilstande og findes i høje koncentrationer hos patienter med de sygdomme, der behandles med Trudexa.
English: Trudexa is used in combination with methotrexate (a medicine that acts on the immune system) in patients with moderate or severe disease who have not responded adequately to other treatments, or patients with severe disease who have not taken methotrexate before.
Danish: Det anvendes ved moderat eller svær sygdom, når anden behandling ikke har virket, og ved svær sygdom, når patienten ikke tidligere har fået methotrexat.
English: For both diseases, the patients had had an inadequate response to previous therapy, and the main measure of effectiveness was the change in symptoms after 12 weeks of treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på ændringen i symptomer efter 12 ugers behandling.
English: For ankylosing spondylitis, Trudexa and placebo as an add-on to existing treatment were compared in two studies involving 397 patients.
Danish: Her blev Trudexa, sammenlignet med placebo, givet som tillægsbehandling til den medicin, patienterne fik i forvejen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tybost on 19 September 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tybost den 19. september 2013.
English: The recommended dose is one tablet per day, taken with food.
Danish: Den anbefalede dosis er én tablet dagligt, der tages sammen med et måltid.
English: This is a summary of the European public assessment report (EPAR) for Tybost.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tybost.
English: Tybost is available as tablets (150 mg).
Danish: Tybost leveres som tabletter (150 mg).
English: The full EPAR for Tybost can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Tybost findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tybost is given together with 300 mg atazanavir once per day or with 800 mg darunavir once per day.
Danish: Tybost gives sammen med 300 mg atazanavir én gang dagligt eller med 800 mg darunavir én gang dagligt.
English: Treatment should be started by a doctor who is experienced in managing HIV infection.
Danish: Behandlingen bør iværksættes af en læge med erfaring i behandling af hiv-infektion.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tybost'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 Tybost er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Tybost was shown to be as effective as ritonavir: around 85% of patients (293 out of 344 patients) given Tybost responded to treatment, compared with around 87% of patients (304 out of 348 patients) given ritonavir.
Danish: Tybost blev fundet at være lige så effektivt som ritonavir: Behandlingen virkede hos 85 % af de patienter (293 ud af 344), der fik Tybost, sammenlignet med cirka 87 % af de patienter (304 ud af 348), der fik ritonavir.
English: Tybost is a medicine that contains the active substance cobicistat.
Danish: Tybost er et lægemiddel, der indeholder det aktive stof cobicistat.
English: A risk management plan has been developed to ensure that Tybost is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Tybost anvendes så risikofrit som muligt.
English: When the enzyme is blocked, the virus cannot reproduce normally, which slows down the spread of infection.
Danish: Når enzymet blokeres, kan virusset ikke formere sig normalt, og derved bremses spredningen af infektionen.
English: What measures are being taken to ensure the safe and effective use of Tybost?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tybost?
English: What is Tybost and what is it used for?
Danish: Hvad er Tybost, og hvad anvendes det til?
English: Tybost can only be obtained with a prescription.
Danish: Tybost udleveres kun efter recept.
English: Other information about Tybost
Danish: Andre oplysninger om Tybost:
English: Why is Tybost approved?
Danish: Hvorfor er Tybost blevet godkendt?
English: It is not intended to provide practical advice on how to use Tybost.
Danish: Det er ikke en praktisk vejledning i, hvordan Tybost bør anvendes.
English: Tybost was compared with another medicine called ritonavir in one main study involving 698 patients infected with HIV-1.
Danish: Tybost blev sammenlignet med et andet lægemiddel, ritonavir, i én hovedundersøgelse med 698 patienter, der var smittet med hiv-1.
English: What are the risks associated with Tybost?
Danish: Hvilke risici er der forbundet med Tybost?
English: Tybost must not be taken together with a number of other medicines that affect the way Tybost is broken down or whose action is affected by Tybost: alfuzosin (used to treat an enlarged prostate gland); amiodarone or quinidine (used to correct irregular heartbeat); carbamazepine, phenobarbital, or phenytoin (used to prevent seizures); rifampicin (used to prevent and treat tuberculosis and other infections); dihydroergotamine, ergometrine or ergotamine (used to treat migraine headache); cisapride (used to relieve certain stomach problems); St. John's wort (a herbal remedy used for depression and anxiety); lovastatin or simvastatin (used to lower blood cholesterol); pimozide (used to treat abnormal thoughts or feelings); sildenafil (used to treat pulmonary arterial hypertension); and oral midazolam or triazolam (used to aid sleep or relieve anxiety).
Danish: Tybost må ikke anvendes sammen med en række andre lægemidler, der påvirker nedbrydningen af Tybost, eller hvis virkning påvirkes af Tybost: Alfuzosin (anvendes til behandling af forstørret blærehalskirtel), amiodaron og kinidin (anvendes til behandling af uregelmæssig hjerterytme), carbamazepin, phenobarbital og phenytoin (anvendes til behandling af kramper), rifampicin (anvendes til forebyggelse og behandling af tuberkulose og andre infektioner), dihydroergotamin, ergometrin og ergotamin (anvendes til behandling af migræne), cisaprid (anvendes til lindring af visse maveproblemer), prikbladet perikum (et plantelægemiddel, der anvendes mod depression og angst), lovastatin og simvastatin (anvendes til at sænke kolesteroltallet), pimozid (anvendes til behandling af abnorme tanker eller følelser), sildenafil (ved anvendelse til behandling af forhøjet tryk i lungearterierne) og midazolam eller triazolam (anvendes mod søvnløshed og angst).
English: For more information about treatment with Tybost, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Tybost, 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 Tybost, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for Tybost er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: It is used in the treatment of adults infected with HIV-1, a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Det anvendes til behandling af voksne, der er smittet med virusset hiv-1, som er årsag til erhvervet immundefektsyndrom (aids).
English: The most common side effects with Tybost (which may affect more than 1 in 10 people) when given with atazanavir are ocular icterus (yellowing of the whites of the eyes), nausea (feeling sick) and jaundice (yellowing of the skin and eyes).
Danish: De hyppigste bivirkninger ved Tybost (som kan forekomme hos mere end 1 ud af hver 10 behandlede) ved anvendelse sammen med atazanavir er gulfarvning af det hvide af øjnene (okulær ikterus), kvalme og gulfarvning af huden og øjnene (gulsot, ikterus).
English: The active substance in Tybost, cobicistat, blocks the action of a group of liver enzymes called CYP3A, which are involved in breaking down medicines in the body.
Danish: Det aktive stof i Tybost, cobicistat, virker ved at blokere leverenzymer af typen CYP3A, der medvirker ved nedbrydningen af lægemidler i kroppen.
English: The CHMP considered that there were no safety concerns preventing Tybost from being used together with atazanavir or darunavir.
Danish: CHMP fandt ingen sikkerhedsmæssige problemer ved anvendelse af Tybost sammen med atazanavir eller darunavir.
English: Studies showed that Tybost was as effective as ritonavir as a booster for atazanavir, and a similar effect is expected for darunavir based on data on the impact of Tybost on the darunavir levels in the body.
Danish: Undersøgelserne viste, at Tybost var lige så effektivt som ritonavir til at forstærke virkningen af atazanavir, og at det forventes at have samme virkning på darunavir ud fra virkningen af Tybost på koncentrationerne af darunavir i kroppen.
English: The study compared these two medicines when used to boost the effects of atazanavir, given in combination with another standard HIV-1 medicine containing emtricitabine and tenofovir.
Danish: Undersøgelsen sammenlignede disse to lægemidler, når de blev anvendt til at forstærke virkningerne af atazanavir i kombination med andre lægemidler, der er standardbehandling mod hiv-1 og indeholder emtricitabin og tenofovir.
English: Tybost is taken with atazanavir or darunavir, both of which are protease inhibitors: they block an enzyme called protease that is involved in the reproduction of the HIV-1 virus.
Danish: Tybost tages sammen med atazanavir eller darunavir, der begge er proteasehæmmere: De blokerer enzymet protease, der medvirker ved hiv-1 virussets formering.
English: The main measure of effectiveness was based on the reduction in viral load (the amount of virus found in the blood): patients who attained a viral load of less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment were considered to have responded to treatment.
Danish: Behandlingen ansås for at have virket, hvis patienterne opnåede et virusindhold på under 50 hiv-1-RNA-kopier/ml efter 48 ugers behandling.
English: For practical information about using Tybost, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Tybost, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: By blocking CYP3A, Tybost slows down the rate at which atazanavir and darunavir are broken down, thereby prolonging the length of time they act in the body.
Danish: Ved at blokere CYP3A bremser Tybost nedbrydningen af atazanavir og darunavir, så deres virkning i kroppen forlænges.
English: Tybost does not treat HIV directly but is given to boost the effects of atazanavir or darunavir, which are used with other standard medicines to treat HIV-1.
Danish: Tybost behandler ikke hiv direkte, men forstærker virkningen af atazanavir og darunavir, der anvendes sammen med andre standardlægemidler til behandling af hiv-1.
English: For the full list of all side effects reported with Tybost, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Tybost fremgår af indlægssedlen.
English: What benefits of Tybost have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Tybost?
English: Treatment with Tybost and atazanavir or darunavir does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS, when combined with other standard HIV-1 medicines.
Danish: Behandling med Tybost og atazanavir eller darunavir helbreder ikke hiv-1-infektion eller aids, men i kombination med andre standardlægemidler mod hiv-1 kan det sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: How is Tybost used?
Danish: Hvordan anvendes Tybost?
English: How does Tybost work?
Danish: Hvordan virker Tybost?
English: This is expected to kill the cancer cells.
Danish: Dette forventes at dræbe kræftcellerne.
English: It usually disappears spontaneously within one week.
Danish: Denne svinder sædvanligvis spontant inden for en uge.
English: This summary was last updated in March 2013.
Danish: Dette sammendrag blev sidst ajourført i 03-2013.
English: Oncept IL-2 reduced the risk of relapse in the period from six months after the start of treatment by approximately 56% after one year and 65% after two years.
Danish: Oncept IL-2 mindskede risikoen for tilbagefald i perioden fra seks måneder efter påbegyndelse af behandlingen med ca. 56 % efter et år og 65 % efter to år.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Onept IL-2 on 3/05/2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Oncept IL-2 den 3. maj 2013.
English: Canarypox viruses do not spread or multiply in cats or in mammals.
Danish: Canarypox virus kan ikke brede sig eller formere sig i katte eller andre pattedyr.
English: Each dose is divided into five injections (of approximately 0.2 ml each) under the skin around the site of the surgically removed tumour.
Danish: Hver dosis fordeles på 5 injektioner (på ca. 0,2 ml hver) under huden omkring det sted, hvor tumoren er bortopereret.
English: It is used in combination with surgery and radiotherapy to reduce the risk of and delay the tumour coming back.
Danish: Det anvendes i kombination med operation og strålebehandling for at nedsætte risikoen for tilbagefald eller forsinke dette.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Oncept IL-2 exceed the risks for the approved indication and recommended that Oncept IL-2 be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Oncept IL-2 overstiger risiciene til den godkendte anvendelse, og anbefalede udstedelse af markedsføringstilladelse for Oncept IL-2.
English: The main measure of effectiveness was the time until the tumours came back or spread (relapse).
Danish: Behandlingens virkning blev hovedsagelig bedømt på den tid, der gik, indtil tumoren kom igen eller bredte sig (tilbagefald).
English: Oncept IL-2 is used when the size of the tumour is between 2 and 5 cm in diameter and there is no spread of the cancer to other parts of the body.
Danish: Oncept IL-2 anvendes, når tumoren har en størrelse mellem 2 og 5 cm i diameter, og kræften ikke har bredt sig til andre dele af kroppen.
English: The studies showed that in cats treated with Oncept IL-2 the tumours took longer to come back (over 730 days based on the mid value of the range) compared with control cats (287 days).
Danish: Undersøgelserne viste, at hos katte, der blev behandlet med Oncept IL-2, var tumoren længere om at vende tilbage (over 730 dage, angivet som midterværdien af variationsbredden) end hos kontrolkattene (287 dage).
English: IL-2 works by stimulating some of the specialised cells of the immune system to attack the cancer cells.
Danish: IL-2 virker ved at stimulere visse specialiserede celler i immunsystemet til at angribe kræftcellerne.
English: The virus allows the production of IL-2 in small amounts and for a prolonged time at the injection site.
Danish: Virusset bevirker, at der produceres IL-2 i små mængder i lang tid på injektionsstedet.