FrancophonIA/ELRC3.0 huggingface dataset:
English: For the treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis) a single dose should be administered at monthly intervals for two consecutive months.
Danish: Ved behandling af skab (forårsaget af Sarcoptes scabiei var. canis) bør der administreres en enkelt dosis månedligt i 2 måneder i træk
English: Each tablet contains: Simparica chewable tablets sarolaner (mg)
Danish: Hver tyggetablet indeholder: Simparica tyggetabletter sarolaner (mg)
English: Simparica chewable tablets sarolaner (mg)
Danish: Simparica tyggetabletter sarolaner (mg)
English: Simparica tablets are chewable and palatable and readily consumed by dogs when offered by the owner.
Danish: Hunde fortærer dem beredvilligt, når de tilbydes af ejeren.
English: EU/2/15/191/001 (5 mg, 1 tablet) EU/2/15/191/002 (5 mg, 3 tablets) EU/2/15/191/003 (5 mg, 6 tablets) EU/2/15/191/004 (10 mg, 1 tablet) EU/2/15/191/005 (10 mg, 3 tablets) EU/2/15/191/006 (10 mg, 6 tablets) EU/2/15/191/007 (20 mg, 1 tablet) EU/2/15/191/008 (20 mg, 3 tablets) EU/2/15/191/009 (20 mg, 6 tablets) EU/2/15/191/010 (40 mg, 1 tablet)
Danish: EU/2/15/191/001 (5 mg, 1 tablet) EU/2/15/191/002 (5 mg, 3 tabletter) EU/2/15/191/003 (5 mg, 6 tabletter) EU/2/15/191/004 (10 mg, 1 tablet) EU/2/15/191/005 (10 mg, 3 tabletter) EU/2/15/191/006 (10 mg, 6 tabletter) EU/2/15/191/007 (20 mg, 1 tablet) EU/2/15/191/008 (20 mg, 3 tabletter) EU/2/15/191/009 (20 mg, 6 tabletter) EU/2/15/191/010 (40 mg, 1 tablet)
English: Simparica 5 mg chewable tablets for dogs 1.3-2.5 kg Simparica 10 mg chewable tablets for dogs >2.5-5 kg Simparica 20 mg chewable tablets for dogs >5-10 kg Simparica 40 mg chewable tablets for dogs >10-20 kg Simparica 80 mg chewable tablets for dogs >20-40 kg Simparica 120 mg chewable tablets for dogs >40-60 kg sarolaner
Danish: Simparica 5 mg tyggetabletter til hunde på 1,3-2,5 kg Simparica 10 mg tyggetabletter til hunde på > 2,5-5 kg Simparica 20 mg tyggetabletter til hunde på > 5-10 kg Simparica 40 mg tyggetabletter til hunde på > 10-20 kg Simparica 80 mg tyggetabletter til hunde på > 20-40 kg Simparica 120 mg tyggetabletter til hunde på > 40-60 kg sarolaner
English: Simparica 5 mg chewable tablets for dogs 1.3-2.5 kg Simparica 10 mg chewable tablets for dogs >2.5-5 kg Simparica 20 mg chewable tablets for dogs >5-10 kg Simparica 40 mg chewable tablets for dogs >10-20 kg Simparica 80 mg chewable tablets for dogs >20-40 kg Simparica 120 mg chewable tablets for dogs >40-60 kg
Danish: Simparica 5 mg tyggetabletter til hunde på 1,3-2,5 kg Simparica 10 mg tyggetabletter til hunde på > 2,5-5 kg Simparica 20 mg tyggetabletter til hunde på > 5-10 kg Simparica 40 mg tyggetabletter til hunde på > 10-20 kg Simparica 80 mg tyggetabletter til hunde på > 20-40 kg Simparica 120 mg tyggetabletter til hunde på > 40-60 kg
English: Treatment schedule:
Danish: Behandling
English: Oral use Oral use bottle (HDPE) blister (alu/alu)
Danish: Oral anvendelse Oral anvendelse flaske (HDPE) blister (alu/alu)
English: 250 tablets 30 tablets
Danish: 250 tabletter 30 tabletter
English: • Need to ensure appropriate hydration of the patient
Danish: • Nødvendigheden af at sikre passende hydrering af patienten
English: • Contraindication in patients with creatinine clearance < 35 ml/min
Danish: • Kontraindikationer hos patienter med kreatininclearance <35 ml/min
English: The MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authorities in Member States prior to distribution of the educational programme.
Danish: Indehaveren af markedsføringstilladelsen skal aftale informationsmaterialets indhold og format samt en kommunikationsplan med de kompetente nationale myndigheder i medlemslandene før distribution af uddannelsesprogrammet.
English: • That all patients should be provided with the educational material and be counselled about:
Danish: • At alle patienter skal have patientinformationsmaterialet stillet til rådighed og skal have rådgivning om:
English: • Need to measure serum creatinine before treatment with Zoledronic acid Teva Pharma
Danish: • Nødvendigheden af at måle serumkreatinin inden behandling med Zoledronsyre Teva Pharma
English: • Need to infuse Zoledronic acid Teva Pharma slowly over a period of no less than 15 minutes
Danish: • Nødvendigheden af at infusere Zoledronsyre Teva Pharma langsomt over en periode på mindst 15
English: • One-yearly dosing regime
Danish: • Doseringsregime én gang årligt.
English: Conditions or restrictions with regard to the safe and effective use of medicinal product to be implemented by the member states
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: o Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non-smoking and healthy diet o Key signs and symptoms of serious adverse events o When to seek attention from the health care provider
Danish: Behovet for tilstrækkeligt indtag af calcium- og Vitamin D-tilskud, passende fysisk aktivitet, rygestop og sund diæt
English: • Contraindication in pregnancy and in breast-feeding women • Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non
Danish: • Behovet for tilstrækkeligt indtag af calcium- og Vitamin D-tilskud, passende fysisk aktivitet,
English: The dose depends on the patient's weight.
Danish: Dosen afhænger af patientens vægt.
English: Orencia received a marketing authorisation valid throughout the EU on 21 May 2007.
Danish: Orencia fik en markedsføringstilladelse med gyldighed i hele EU den 21. maj 2007.
English: Further information on Orencia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/orencia.
Danish: Yderligere information om Orencia findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/orencia.
English: Other information about Orencia
Danish: Andre oplysninger om Orencia
English: The main measure of effectiveness was how long it was before the patient's disease flared up again.
Danish: Det primære mål for virkning var, hvor lang tid der gik, inden patientens sygdom blussede op igen.
English: As for all medicines, data on the use of Orencia is continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Orencia løbende overvåget.
English: Around three-quarters of the patients were also taking methotrexate.
Danish: Ca. tre fjerdedele af patienterne fik også methotrexat.
English: What measures are being taken to ensure the safe and effective use of Orencia?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Orencia?
English: If Orencia has not worked within 6 months, the doctor should consider if treatment should continue.
Danish: Hvis Orencia ikke har haft nogen virkning inden for 6 måneder, bør lægen tage stilling til, om behandlingen skal fortsætte eller ej.
English: Side effects reported with Orencia are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Orencia vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: What is Orencia and what is it used for?
Danish: Hvad er Orencia, og hvad anvendes det til?
English: An overview of Orencia and why it is authorised in the EU
Danish: En oversigt over Orencia, og hvorfor det er godkendt i EU
English: Patients taking Orencia also had a greater improvement in physical function after six months.
Danish: Patienter, der fik Orencia, opnåede desuden bedre fysisk funktion efter 6 måneder.
English: Orencia contains the active substance abatacept.
Danish: Orencia indeholder det aktive stof abatacept.
English: Why is Orencia authorised in the EU?
Danish: Hvorfor blev Orencia godkendt i EU?
English: For more information about using Orencia, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Orencia, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: The Agency decided that Orencia's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede, at fordelene ved Orencia opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: When given by infusion into a vein, Orencia is given every 2 weeks for the first 3 doses, and then every 4 weeks.
Danish: Ved infusion (drop) i en blodåre indgives Orencia hver 2. uge for de første 3 doser og derefter hver 4. uge.
English: In this case it should be followed by an injection under the skin the next day.
Danish: I så fald skal denne efterfølges af en injektion under huden dagen efter.
English: T cells are activated when signal molecules attach to receptors on the cells.
Danish: T-celler aktiveres, når signalmolekyler binder til receptorer på cellerne.
English: Children between 2 and 6 years should only use Orencia pre-filled syringes.
Danish: Hos børn i alderen 2-6 år bør der kun anvendes Orencia i fyldte sprøjter.
English: What are the risks associated with Orencia?
Danish: Hvilke risici er der forbundet med Orencia?
English: The main measure of effectiveness was a reduction in symptoms of at least 20% after 24 weeks of treatment.
Danish: Det primære mål for virkning var en reduktion i symptomerne på mere end 20 % efter 24 ugers behandling.
English: In around 60% of these patients the TNF alpha blocker had not worked well enough.
Danish: Hos ca. 60 % af disse patienter havde TNF-alfa-hæmmeren ikke haft tilstrækkelig virkning.
English: The active substance in Orencia, abatacept, is a protein that suppresses the activation of T cells.
Danish: Det aktive stof i Orencia, abatacept, er et protein, der undertrykker aktiveringen af T-celler.
English: Orencia is a medicine that is often used in combination with methotrexate (a medicine that acts on the immune system) to treat the following diseases:
Danish: Orencia er et lægemiddel, der ofte anvendes i kombination med methotrexat (et lægemiddel, der virker på immunsystemet) til behandling af følgende sygdomme:
English: All patients received Orencia for 4 months, after which the 122 whose condition had improved on Orencia were either switched to placebo or continued receiving Orencia.
Danish: Alle patienter fik Orencia i 4 måneder, hvorefter de 122 patienter, der havde fået det bedre på Orencia, enten skiftede til placebo eller fortsatte på Orencia.
English: Rheumatoid arthritis
Danish: Reumatoid artritis
English: By attaching to signal molecules called CD80 and CD86, abatacept stops them activating the T cells, helping to reduce the inflammation and other symptoms of the diseases.
Danish: Abatacept binder til signalmolekylerne CD80 og CD86 og forhindrer dem dermed i at aktivere T-cellerne, hvorved betændelse og andre symptomer ved disse sygdomme reduceres.
English: Orencia must not be used in patients with severe and uncontrolled infections, such as sepsis (when bacteria and their toxins circulate in the blood and start to damage the organs) or ‘opportunistic' infections (infections seen in patients with a weakened immune system).
Danish: Orencia må ikke anvendes hos patienter med svære og ukontrollerede infektioner som f.eks. sepsis (blodforgiftning (når bakterier og disses toksiner cirkulerer i blodet og begynder at beskadige organerne)) eller såkaldt opportunistiske infektioner (infektioner, der kan forekomme hos patienter med et svækket immunsystem).
English: Patients who receive Orencia are given a special alert card explaining that it must not be used in patients with certain infections and instructing patients to contact their doctor immediately if they develop an infection during treatment with Orencia.
Danish: Patienter, som får Orencia, får udleveret et særligt informationskort med instruktioner om, at Orencia ikke må tages af personer med visse infektioner, og instruktioner om straks at kontakte lægen, hvis de udvikler en infektion under behandling med Orencia.
English: Orencia was also shown to reduce symptoms of psoriatic arthritis.
Danish: Det er også påvist, at Orencia reducerer symptomerne ved psoriasisartritis.
English: The most common side effects with Orencia (seen in more than 1 patient in 10) are upper respiratory tract infections (nose and throat infection).
Danish: De hyppigste bivirkninger ved Orencia (der kan forekomme hos mere end 1 ud af 10 patienter) er infektioner i de øvre luftveje (næse og svælg).
English: The study included 259 patients who had previously been treated with a TNF alpha blocker.
Danish: Studiet omfattede 259 patienter, der tidligere var blevet behandlet med en TNF-alfa-hæmmer.
English: The Agency also concluded that Orencia could be a valuable option in the treatment of polyarticular juvenile idiopathic arthritis.
Danish: Agenturet konkluderede også, at Orencia kan være en værdifuld behandlingsmulighed ved polyartikulær juvenil idiopatisk artritis.
English: When injected under the skin, Orencia is given once a week.
Danish: Ved injektion under huden indgives Orencia én gang om ugen.
English: The main measures of effectiveness were the reduction in symptoms of arthritis after treatment, as well as physical function (the ability to carry out everyday tasks) and the amount of damage to the joints (assessed using X-rays).
Danish: De primære mål for virkning var mindskelse af symptomerne på artritis efter behandling, patienternes fysiske funktion (evnen til at udføre daglige aktiviteter) og omfanget af ledskader (vurderet på røntgenbilleder).
English: The first two studies included 991 patients in whom methotrexate had not worked well enough.
Danish: De to første studier omfattede 991 patienter, hos hvem methotrexat ikke havde haft tilstrækkelig virkning.
English: Four main studies involving a total of 1,733 adults found Orencia effective in rheumatoid arthritis.
Danish: I fire hovedstudier med i alt 1.733 voksne blev Orencia fundet effektivt til behandling af reumatoid artritis.
English: It is used alone or in combination with methotrexate for patients who do not need other medicines by mouth or by injection to control their psoriasis.
Danish: Orencia anvendes alene eller i kombination med methotrexat hos patienter, der ikke har brug for andre lægemidler administreret gennem munden eller ved injektion for at kontrollere deres psoriasis.
English: Orencia can only be obtained with a prescription, and treatment with it should be started and supervised by a specialised doctor with experience in the diagnosis and treatment of rheumatoid arthritis or polyarticular juvenile idiopathic arthritis.
Danish: Orencia udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en speciallæge med erfaring i diagnosticering og behandling af reumatoid artritis eller polyartikulær juvenil idiopatisk artritis.
English: In the fourth study, Orencia in combination with methotrexate was compared with Orencia alone and methotrexate alone in 351 adults who had not been treated with methotrexate (or with any biologic agents such as TNF alpha blockers), but may have been on other medicines for management of rheumatoid arthritis.
Danish: I det fjerde studie blev Orencia i kombination med methotrexat sammenlignet med Orencia alene og methotrexat alene hos 351 voksne, som ikke tidligere var blevet behandlet med methotrexat (eller med biologiske lægemidler som f.eks. TNF-alfa-hæmmere), men som eventuelt havde modtaget anden behandling for reumatoid artritis.
English: In rheumatoid arthritis, if the patient is receiving Orencia for the first time, the first dose can be given by infusion.
Danish: Hvis patienten har reumatoid artritis, og hvis det er første gang, han/hun får Orencia, kan den første dosis indgives ved infusion (drop).
English: T cells are immune system cells that are involved in causing the inflammation in rheumatoid, psoriatic and polyarticular juvenile idiopathic arthritis.
Danish: T-celler er celler i immunsystemet, der er med til at forårsage betændelse ved reumatoid artritis, psoriasisartritis og polyartikulær juvenil idiopatisk artritis.
English: The European Medicines Agency concluded that Orencia had a modest anti-inflammatory effect in rheumatoid arthritis and, in combination with methotrexate, it reduced the worsening of joint damage and improved physical function.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at Orencia har en let antiinflammatorisk (betændelseshæmmende) effekt på reumatoid artritis, og at det i kombination med methotrexat kan reducere forværringen af ledskader og forbedre den fysiske funktion.
English: What benefits has Orencia have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Orencia?
English: Psoriatic arthritis
Danish: Psoriasisartritis
English: The second study found a similar effect of Orencia on symptoms of rheumatoid arthritis, as well as improved physical function and a reduced rate of joint damage after a year of treatment.
Danish: I det andet studie sås en tilsvarende virkning af Orencia på symptomerne på reumatoid artritis foruden en bedring i den fysiske funktion og færre ledskader efter et års behandling.
English: • highly active and progressive rheumatoid arthritis, used in combination with methotrexate in adults who have not previously been treated with methotrexate;
Danish: • Højaktiv og fremadskridende reumatoid artritis hos voksne, der tager det i kombination med methotrexat, og som ikke tidligere er blevet behandlet med methotrexat.
English: A further study in 219 children with polyarticular juvenile idiopathic arthritis aged 2 to 17 years showed that Orencia given by injection under the skin produced expected levels of active substance in the blood based on data with Orencia given into a vein for other conditions.
Danish: I et yderligere studie af 219 børn med polyartikulær juvenil idiopatisk artritis i alderen 2-17 år medførte Orencia indgivet ved injektion under huden det forventede niveau af aktivt stof i blodet baseret på data for Orencia indgivet ved infusion (drop) til behandling af andre sygdomme.
English: • moderate to severe active polyarticular juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints), in adolescents and children from 2 years of age in whom other medicines have not worked well enough.
Danish: • Moderat til svær aktiv polyartikulær juvenil idiopatisk artritis (en sjælden børnesygdom, der forårsager betændelse i mange led) hos unge og børn fra 2-års alderen, hos hvem andre lægemidler ikke har haft tilstrækkelig virkning.
English: It is used in combination with methotrexate, or on its own in patients who cannot take methotrexate.
Danish: Orencia anvendes i kombination med methotrexat eller som enebehandling hos patienter, der ikke kan tage methotrexat.
English: How does Orencia work?
Danish: Hvordan virker Orencia?
English: Orencia is available as a powder that is made up into a solution for infusion (drip) into a vein and as a solution for injection under the skin in pre-filled syringes and pre-filled pens.
Danish: Orencia fås som et pulver, der blandet til en opløsning og indgives ved infusion (drop) i en blodåre, samt som en injektionsvæske i fyldte sprøjter og penne til injektion under huden.
English: • psoriatic arthritis (arthritis combined with psoriasis, a condition causing red, scaly patches on the skin) in adults in whom treatment with other medicines, including methotrexate, has not worked well enough.
Danish: • Psoriasisartritis (artritis kombineret med psoriasis, en tilstand, der giver røde, skællende pletter på huden) hos voksne, hos hvem behandling med andre lægemidler, herunder methotrexat, ikke har haft tilstrækkelig virkning.
English: In addition, a study involving around 1,370 patients with rheumatoid arthritis found similar benefit for both Orencia given by injection under the skin and Orencia given by infusion.
Danish: I et studie af ca. 1.370 patienter med reumatoid artritis sås det desuden, at patienterne havde samme gavn af Orencia indgivet ved injektion under huden som af Orencia indgivet ved infusion (drop).
English: The third study included 391 patients in whom TNF blockers had not worked well enough.
Danish: Det tredje studie omfattede 391 patienter, hos hvem TNF-hæmmere ikke havde haft tilstrækkelig virkning.
English: How is Orencia used?
Danish: Hvordan anvendes Orencia?
English: Subsequently, it is injected under the skin once a week.
Danish: Derefter injiceres Orencia under huden én gang om ugen.
English: The study also led to similar improvements in symptoms to those seen with Orencia given into a vein in adults and children.
Danish: I studiet sås også samme symptombedring, som når Orencia indgives ved infusion (drop) hos voksne og børn.
English: Orencia given by injection under the skin reduced symptoms in 39% of the patients (84 out of 213) compared with 22% of the patients (47 out of 211) who received placebo.
Danish: Orencia indgivet ved injektion under huden reducerede symptomerne hos 39 % af patienterne (84 ud af 213), sammenholdt med 22 % af de patienter (47 ud af 211), der fik placebo.
English: Over 6 months, 20% of the patients receiving Orencia had a flare-up (12 out of 60), compared with 53% of those receiving placebo (33 out of 62).
Danish: Over en periode på 6 måneder oplevede 20 % af de patienter, som fik Orencia, en opblussen (12 ud af 60), sammenholdt med 53 % af de patienter, der fik placebo (33 ud af 62).
English: Adding Orencia and methotrexate to existing treatment for 12 months reduced symptoms in 61% of the patients (70 out of 115), compared with 42% of the patients on Orencia alone (48 out of 113) and 45% of the patients on methotrexate alone (52 out of 115).
Danish: Tilføjelse af Orencia og methotrexat til eksisterende behandling i 12 måneder medførte en reduktion af symptomerne hos 61 % af patienterne (70 ud af 115), sammenholdt med 42 % af de patienter, der kun fik Orencia (48 ud af 113), og 45 % af de patienter, der kun fik methotrexat (52 ud af 115).
English: Adding Orencia to existing treatment led to a reduction in symptoms in 50% of the patients (129 out of 256) after 6 months, compared with 20% of the patients adding placebo (26 out of 133).
Danish: Tilføjelse af Orencia til eksisterende behandling førte til en reduktion af symptomerne hos 50 % af patienterne (129 ud af 256) efter 6 måneder, sammenholdt med 20 % af de patienter, der fik tilføjet placebo (26 ud af 133).
English: In polyarticular juvenile idiopathic arthritis, Orencia infusion was found effective in one main study involving patients aged between 6 and 17 years whose previous treatment had not worked.
Danish: Hvad angår polyartikulær juvenil idiopatisk artritis, sås det i et hovedstudie af patienter i alderen 617 år, hos hvem tidligere behandling ikke havde virket, at infusion med Orencia var effektivt.
English: In another study involving 170 patients with psoriatic arthritis, Orencia given by infusion at the recommended dose reduced symptoms by at least 20% after 24 weeks in over 47% of the patients (19 out of 40) compared with 19% of the patients (8 out of 42) who received placebo.
Danish: I et andet studie af 170 patienter med psoriasisartritis sås det, at Orencia indgivet ved infusion (drop) i den anbefalede dosis reducerede symptomerne med mindst 20 % efter 24 ugers behandling hos over 47 % af patienterne (19 ud af 40), sammenholdt med 19 % af de patienter (8 ud af 42), der fik placebo.
English: • moderate to severe active rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints) in adults using it in combination with methotrexate when other medicines including methotrexate or a ‘tumour necrosis factor (TNF) blocker' have not worked well enough;
Danish: • Moderat til svær aktiv reumatoid artritis (også kaldet leddegigt, der er en sygdom i immunsystemet, som giver skader og betændelse i leddene) hos voksne, der tager det i kombination med methotrexat, når andre lægemidler, herunder methotrexat eller en såkaldt TNFhæmmer (tumornekrosefaktor-hæmmer), ikke har haft tilstrækkelig virkning.