FrancophonIA/ELRC3.0 huggingface dataset:
English: Responses of patients with ankylosing spondylitis in a placebo-controlled trial Percent of Patients
Danish: Respons hos patienter med ankyloserende spondylitis i et placebo-kontrolleret studie Procent af patienter
English: Undesirable effects in paediatric patients with plaque psoriasis In a 48-week study in 211 children aged 4 to 17 years with paediatric plaque psoriasis, the adverse events reported were similar to those seen in previous studies in adults with plaque psoriasis.
Danish: Bivirkninger hos pædiatriske patienter med plaque psoriasis I et studie af 48 ugers varighed med 211 børn i alderen 4 til 17 år med pædiatrisk plaque psoriasis var de indberettede bivirkninger de samme som dem, man havde set i tidligere studier hos voksne med plaque psoriasis.
English: If there is bleeding at the injection site, press a gauze pad over the injection site.
Danish: Hvis injektionsstedet bløder, trykker du et stykke gazebind ned på injektionsstedet.
English: The mean serum steady-state trough concentrations ranged from 1.6 to 2.1 mcg/ml at weeks 12, 24, and 48.
Danish: De gennemsnitlige steady-state trough-koncentrationer i serum varierede fra 1,6 til 2,1 mikrog/ml ved uge 12, 24 og 48.
English: Benepali should be discarded if not used within four weeks after removal from the refrigerator.
Danish: Benepali skal kasseres, hvis det ikke er brugt inden for 4 uger efter, at det er taget ud af køleskabet.
English: Name and address of the manufacturer of the biological active substance Biogen (Denmark) Manufacturing ApS Biogen Allé 1
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Biogen (Denmark) Manufacturing ApS Biogen Allé 1
English: • Alcohol abuse: Benepali should not be used for the treatment of hepatitis related to alcohol abuse.
Danish: • Alkoholmisbrug: Benepali må ikke bruges til behandling af leverbetændelse (hepatitis) i forbindelse med alkoholmisbrug.
English: No dose-limiting toxicities were observed during clinical trials of rheumatoid arthritis patients.
Danish: Der blev ikke observeret dosisbegrænsende toksiciteter under kliniske studier med patienter med reumatoid artrit.
English: • Infections/surgery: If you or the child develop a new infection, or are about to have any major surgery, your doctor may wish to monitor the treatment with Benepali.
Danish: • Infektioner/operation: Hvis du eller barnet udvikler en ny infektion eller skal gennemgå en større operation i den nærmeste fremtid, vil lægen muligvis ønske at overvåge behandlingen med Benepali.
English: This card contains important safety information that you need to be aware of before you are given Benepali and during treatment with Benepali.
Danish: Dette kort indeholder vigtige oplysninger, som du skal være klar over, inden du får Benepali og under din behandling med Benepali.
English: Some vaccines, such as oral polio vaccine, should not be given while using Benepali.
Danish: Nogle vacciner, som for eksempel oral poliovaccine, må ikke gives, mens man får Benepali.
English: • Signs of autoimmune reactions (where antibodies are made that may harm normal tissues in the body) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision;
Danish: • Tegn på autoimmune reaktioner (hvor der dannes antistoffer, der kan skade normalt væv i kroppen), som f.eks. smerter, kløe, svaghed og unormal vejrtrækning, tankegang, følesans eller syn.
English: Benepali may be stored at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again.
Danish: Benepali kan opbevares ved temperaturer op til højst 25 °C i en enkelt periode på op til 4 uger, hvorefter det ikke må nedkøles igen.
English: EU/1/15/1074/006 multipack of 8 pre-filled syringes (2 packs of 4) EU/1/15/1074/007 multipack of 24 pre-filled syringes (6 packs of 4)
Danish: EU/1/15/1074/006 multipakning med 8 fyldte injektionssprøjter (2 pakker á 4) EU/1/15/1074/007 multipakning med 24 fyldte injektionssprøjter (6 pakker á 4)
English: Methotrexate doses were escalated from 7.5 mg/week to a maximum of 20 mg/week over the first 8 weeks of the trial and continued for up to 24 months.
Danish: Methotrexatdoser blev gradvist øget fra 7,5 mg/uge til en maksimal dosis på 20 mg/uge over de første 8 uger af studiet og fortsatte herefter i op til 24 måneder.
English: In another observational multi-country registry study comparing the risk of adverse pregnancy outcomes in women exposed to etanercept during the first 90 days of pregnancy (n=425) to those exposed to non-biologic drugs (n=3497), there was no observed increased risk of major birth defects (crude odds ratio [OR]= 1.22, 95% CI: 0.79-1.90; adjusted OR = 0.96, 95% CI: 0.58-1.60 after adjusting for country, maternal disease, parity, maternal age and smoking in early pregnancy).
Danish: Et andet observationelt registerstudie omfattende flere lande sammenlignede risikoen for negative graviditetsudfald hos kvinder, der blev eksponeret for etanercept i de første 90 dage af graviditeten (n=425) sammenlignet med dem, der blev eksponeret for ikke-biologiske lægemidler (n=3497), og her blev der ikke observeret en øget risiko for alvorlige fødselsdefekter (odds ratio [OR]= 1,22, 95 % CI: 0,79-1,90; justeret OR = 0,96, 95 % CI: 0,58-1,60 efter justering efter land, maternel sygdom, paritet, maternel alder og rygning tidligt i graviditeten).
English: If active tuberculosis is diagnosed, Benepali therapy must not be initiated.
Danish: Hvis diagnosen aktiv tuberkulose stilles, må behandling med Benepali ikke påbegyndes.
English: If you forget to inject Benepali
Danish: Hvis du har glemt at injicere Benepali
English: Histiocytosis haematophagic (macrophage activation syndrome)*
Danish: haematophagic (makrofagaktiv eringssyndrom)
English: The highest dose level evaluated has been an intravenous loading dose of 32 mg/m2 followed by subcutaneous doses of 16 mg/m2 administered twice weekly.
Danish: Den største dosis, der er blevet evalueret, var en intravenøs støddosis på 32 mg/m2 efterfulgt af subkutane doser på 16 mg/m2, indgivet to gange ugentligt.
English: Dispose of the empty pen in an approved sharps container.
Danish: Bortskaf den tomme pen i en godkendt kanyleboks.
English: Percent of Patients Placebo n = 104
Danish: Procent af patienter Placebo n = 104
English: Serious allergic/anaphyla ctic reactions (including angioedema, bronchospasm), sarcoidosis
Danish: Alvorlige allergiske/anafyl aktiske reaktioner (inklusive angioødem, bronkospasme), sarkoidose
English: • A new Benepali pre-filled pen o Do not shake the pre-filled pen.
Danish: • En ny fyldt pen med Benepali o Du må ikke ryste den fyldte pen.
English: Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNFantagonists, including etanercept.
Danish: Der er indberetninger om melanom og ikke-melanom hudkræft (NMSC) hos patienter behandlet med TNF-antagonister, herunder etanercept.
English: Etanercept did not elicit dose-limiting or target organ toxicity in cynomolgus monkeys following twice weekly subcutaneous administration for 4 or 26 consecutive weeks at a dose (15 mg/kg) that resulted in AUCbased serum drug concentrations that were over 27-fold higher than that obtained in humans at the recommended dose of 25 mg.
Danish: Etanercept fremkaldte ikke dosisbegrænsende eller målorgantoksicitet hos cynomolgus-aber efter subkutan indgivelse to gange ugentligt i 4 eller 26 uger i træk med en dosis (15 mg/kg), som resulterede i AUCbaserede serumkoncentrationer af stoffet, der var over 27 gange højere end dem, der blev opnået hos mennesker ved den anbefalede dosis på 25 mg.
English: Patients in the etanercept in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below).
Danish: Gruppen af patienter i behandling med etanercept i kombination med methotrexat havde signifikant højere ACR 20-, ACR 50-, ACR 70-respons og forbedring af DAS- og HAQ-score ved både 24 og 52 uger end patienterne i hver af enkeltterapi-grupperne (resultater vises i tabellen nedenfor).
English: The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study in 211 paediatric patients aged 4 to 17 years with moderate to severe plaque psoriasis (as defined by an sPGA score ≥ 3, involving ≥ 10% of the BSA, and PASI ≥ 12).
Danish: Effekten af etanercept blev vurderet i et randomiseret, dobbeltblindt, placebo-kontrolleret studie med 211 pædiatriske patienter i alderen 4 til 17 år med moderat til svær plaque psoriasis (defineret ved en sPGA score ≥ 3, omfattende ≥ 10 % af BSA og PASI ≥ 12).
English: • Vaccinations: Some vaccines, such as oral polio vaccine, should not be given during Benepali therapy.
Danish: • Vaccinationer: Nogle vacciner, som for eksempel oral poliovaccine, må ikke gives, mens man får Benepali.
English: All patients and parents/caregivers should be advised that if the patient develops signs and symptoms suggestive of blood dyscrasias or infections (e.g., persistent fever, sore throat, bruising, bleeding, and paleness) whilst on Benepali, they should seek immediate medical advice.
Danish: Alle patienter og forældre/plejere skal informeres om, at hvis patienten udvikler tegn eller symptomer, som kan pege på bloddyskrasi eller infektioner (f.eks. vedvarende feber, ondt i halsen, blå mærker, blødning og bleghed), mens de er i behandling med Benepali, skal de omgående søge læge.
English: Your symptoms may return upon discontinuation.
Danish: Symptomerne kan vende tilbage, hvis behandlingen stoppes.
English: Developmental toxicity studies performed in rats and rabbits have revealed no evidence of harm to the foetus or neonatal rat due to etanercept.
Danish: Udviklingstoksicitetsstudier udført på rotter og kaniner har ikke afsløret nogen tegn på beskadigelse af foster eller nyfødte rotter på grund af etanercept.
English: In the 2-year activecontrolled study where patients were treated with either etanercept alone, methotrexate alone or etanercept in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
Danish: I det to-årige aktivt kontrollerede studie, hvor patienterne blev behandlet med enten etanercept alene, methotrexat alene eller etanercept i behandling med methotrexat, var antallet af alvorlige infektioner det samme i behandlingsgrupperne.
English: Detailed instructions on how to inject Benepali are provided in section 7, “Instructions for use”.
Danish: Detaljeret vejledning om injektion af Benepali findes i punkt 7, "Brugsanvisning".
English: There were no differences in rates of infection among patients treated with etanercept and those treated with placebo for plaque psoriasis in placebo-controlled trials of up to 24 weeks duration.
Danish: Der var ingen forskel i infektionsraten blandt patienter behandlet med etanercept og patienter, som fik placebo mod plaque psoriasis, i placebo-kontrollerede studier af op til 24 ugers varighed.
English: The long-term safety and effectiveness of etanercept 0.8 mg/kg (up to 50 mg) once weekly was assessed in an open-label extension study of 181 paediatric subjects with plaque psoriasis for up to 2 years beyond the 48 week study discussed above.
Danish: Langtidssikkerhed og -virkning af etanercept 0,8 mg/kg (op til 50 mg) én gang ugentligt blev vurderet i et open-label forlængelsesstudie med 181 pædiatriske patienter med plaque psoriasis i op til 2 år ud over det 48-ugers studie, der er nævnt herover.
English: In a study of 49 adult patients with rheumatoid arthritis treated with etanercept, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations.
Danish: I et studie med 49 voksne patienter med reumatoid artrit, som blev behandlet med etanercept, var der ingen tegn på nedsættelse af tardiv overfølsomhed, nedsættelse af immunglobulinniveauer eller ændring i optællingen af effektorcellepopulationer.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including etanercept, in the postmarketing setting.
Danish: Efter markedsføring er der rapporteret om maligniteter, heraf nogle letale, hos børn, unge og unge voksne (op til 22 år), der er behandlet med TNF-antagonister (start på behandling ≤ 18 år), herunder etanercept.
English: The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with etanercept, relative to placebo (p < 0.001).
Danish: Scoren på invaliditetsindekset blev signifikant forbedret på alle tidspunkter hos patienter med psoriasisartrit i behandling med etanercept i sammenligning med placebo (p < 0,001).
English: In controlled trials in patients with plaque psoriasis, approximately 13.6% of patients treated with etanercept developed injection site reactions compared with 3.4% of placebo-treated patients during the first 12 weeks of treatment.
Danish: I kontrollerede studier med patienter med plaque psoriasis fik ca. 13,6 % af patienterne behandlet med etanercept reaktioner på injektionsstedet i løbet af de første 12 ugers behandling sammenlignet med 3,4 % af patienterne behandlet med placebo.
English: • Do not release pressure against the injection site before the injection is complete.
Danish: • Du må ikke lette trykket på injektionsstedet, inden injektionen er færdig.
English: Solution for injection (injection).
Danish: Injektionsvæske, opløsning (injektion)
English: Failure of the bone marrow to produce crucial blood cells; damage to nerves, including Guillain-Barré syndrome (a serious condition which can affect breathing and damage body organs); toxic epidermal necrolysis (a life-threatening skin condition).
Danish: Knoglemarvens manglende evne til at danne vigtige blodlegemer, nerveskader, herunder Guillain-Barré-syndrom (en alvorlig tilstand, der kan påvirke åndedrættet og beskadige kropsorganer), toksisk epidermal nekrolyse (en livstruende hudlidelse).
English: Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-antagonists, including etanercept, has been reported.
Danish: Der er indberetninger om reaktivering af hepatitis B hos patienter, som tidligere havde været inficeret med hepatitis B-virus (HBV), og som samtidig fik behandling med TNF-antagonister, herunder etanercept.
English: At week 104, the mean change from baseline in the SPARCC score measured on MRI for all etanercept-treated subjects was 4.64 for the SIJ (n=153) and 1.40 the spine (n=154).
Danish: I uge 104 var den gennemsnitlige ændring fra baseline i SPARCC-scoren målt ved hjælp af MR hos alle patienter, der fik etanercept 4,64 for SI-leddet (n=153) og 1,40 for rygsøjlen (n=154).
English: Among patients receiving etanercept, the clinical responses generally appeared within 1 to 2 weeks after initiation of therapy and nearly always occurred by 3 months.
Danish: Blandt de patienter, der fik etanercept, viste de kliniske reaktioner sig generelt inden for 1-2 uger efter påbegyndelse af behandlingen og skete næsten altid senest i måned 3.
English: lymphoma, leukaemia
Danish: 4.4), lymfom, leukæmi
English: Your doctor may decide if you or the child need less anti-diabetic medicine while taking Benepali.
Danish: Lægen kan beslutte, at du eller barnet skal have en mindre dosis medicin mod sukkersyge, mens du får Benepali.
English: • Always keep the container out of the sight and reach of children.
Danish: • Opbevar altid kanyleboksen utilgængeligt for børn.
English: Benepali treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis.
Danish: Behandling med Benepali bør iværksættes og overvåges af specialister med erfaring i diagnosticering og behandling af reumatoid artrit, juvenil idiopatisk artrit, psoriasisartrit, ankyloserende spondylitis, nonradiografisk aksial spondylartrit, plaque psoriasis eller pædiatrisk plaque psoriasis.
English: • Feeling nervous or anxious, throbbing sensations, sudden reddening of the skin and/or a warm feeling
Danish: • Følelse af nervøsitet eller angst, bankende fornemmelser eller pludselig rødmen i huden og/eller en følelse af varme.
English: The differences in TSS and JSN were not statistically significant between methotrexate and etanercept 25 mg.
Danish: Forskellene i TSS og JSN mellem methotrexat og etanercept 25 mg var ikke statistisk signifikant.
English: Benepali contains sodium
Danish: Benepali indeholder natrium
English: One rheumatoid arthritis patient mistakenly self-administered 62 mg etanercept subcutaneously twice weekly for 3 weeks without experiencing undesirable effects.
Danish: En patient med reumatoid artrit tog ved en fejltagelse 62 mg etanercept subkutant to gange om ugen i tre uger uden at registrere uønskede virkninger.
English: - This medicine has been prescribed for you or a child in your care.
Danish: - Lægen har ordineret dette lægemiddel til dig eller dit barn personligt.
English: Long-term safety of etanercept monotherapy (n = 103), etanercept plus methotrexate (n = 294), or methotrexate monotherapy (n = 197) were assessed for up to 3 years in a registry of 594 children aged 2 to 18 years with juvenile idiopathic arthritis, 39 of whom were 2 to 3 years of age.
Danish: Langtidssikkerhedsdata for etanercept som monoterapi (n = 103), etanercept plus methotrexat (n = 294) eller methotrexat som monoterapi (n = 197) blev vurderet i op til 3 år i et register med 594 børn i alderen 2-18 år med juvenil idiopatisk artrit; heraf var 39 i alderen 2-3 år.
English: The efficacy of etanercept was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (< 3 years duration) who had never received treatment with methotrexate.
Danish: Effekten af etanercept blev sammenlignet med methotrexat i et randomiseret, aktivt kontrolleret studie med blindet radiografisk evaluering som primært mål hos 632 voksne patienter med aktiv reumatoid artrit (< 3 års varighed), som ikke tidligere var blevet behandlet med methotrexat.
English: 70b a 25 mg etanercept SC twice weekly b p < 0.001, etanercept vs. placebo c p < 0.01, etanercept vs. placebo
Danish: 70b a 25 mg etanercept subkutant to gange om ugen b p < 0,001, etanercept vs. placebo c p < 0,01, etanercept vs. placebo
English: - The other ingredients are sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate,
Danish: - Øvrige indholdsstoffer: saccharose, natriumchlorid, natriumdihydrogenphosphatmonohydrat,
English: Benepali, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Danish: Benepali, alene eller i kombination med methotrexat, har vist sig at reducere udviklingen af ledskader, målt ved hjælp af røntgen, og at forbedre den fysiske funktion.
English: Thus, the combined use of Benepali and anakinra is not recommended (see sections 4.5 and 4.8).
Danish: Derfor frarådes denne kombinerede brug af Benepali og anakinra (se pkt.
English: The safety and efficacy of etanercept in patients with immunosuppression have not been evaluated.
Danish: Sikkerhed og effekt ved brug af etanercept til patienter med immunsuppression er ikke blevet vurderet.
English: In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in etanercept-treated patients.
Danish: I kliniske studier af mere end 2 års varighed med 351 patienter med ankyloserende spondylitis blev der rapporteret om 6 maligniteter hos patienter behandlet med etanercept.
English: Your doctor will determine if Benepali is an appropriate treatment.
Danish: Lægen vil afgøre, om behandling med Benepali er hensigtsmæssig.
English: Continued durable responses have been seen for up to 10 years in open-label extension treatment trials when patients received etanercept without interruption.
Danish: Fortsat, varigt respons er set i op til 10 år i åbne, forlængede studier hos patienter, som fik etanercept uden afbrydelse.
English: Tell your doctor immediately, or go to the casualty department at your nearest hospital.
Danish: Fortæl det straks til lægen, eller tag på skadestuen på det nærmeste hospital.
English: The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with etanercept compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with etanercept compared to none of placebo-treated patients).
Danish: Den procentdel af patienter, som udviklede nye positive anti-dobbeltstrengede DNA-antistoffer, var også højere ved radioimmunbestemmelse (15 % af patienter, der blev behandlet med etanercept, sammenlignet med 4 % af de patienter, der fik placebo) og ved Crithidia liciliae-bestemmelse (3 % af patienter, der blev behandlet med etanercept sammenlignet med ingen af de patienter, der fik placebo).
English: Compared to placebo, treatment with etanercept resulted in significant improvements in the ASAS 20, ASAS 50 and ASAS 70 as early as 2 weeks after the initiation of therapy.
Danish: Sammenlignet med placebo resulterede behandling med etanercept i signifikante forbedringer i ASAS 20, ASAS 50 og ASAS 70 så tidligt som 2 uger efter påbegyndelse af behandling.
English: One hundred and twenty-nine (129) new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with etanercept for up to approximately 6 years, including 231 patients treated with etanercept in combination with methotrexate in the 2-year activecontrolled study.
Danish: Der er observeret 129 nye maligniteter af forskellig type hos 4.114 patienter med reumatoid artrit, som i kliniske studier blev behandlet med etanercept i op til ca. 6 år, inklusive 231 patienter behandlet med etanercept i kombination med methotrexat i det to-årige aktivt kontrollerede studie.
English: In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their etanercept dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
Danish: I studie 3 opretholdt hovedparten af de patienter (77 %), som initialt blev randomiseret til 50 mg to gange om ugen og som fik nedsat deres etanercept-dosis til 25 mg to gange om ugen efter 12 uger, deres PASI 75-respons til uge 36.
English: In clinical trials, no interactions have been observed when etanercept was administered with glucocorticoids, salicylates (except sulfasalazine), nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, or methotrexate.
Danish: Der er ikke observeret nogen interaktion i kliniske studier, hvor etanercept blev indgivet sammen med glukokortikoider, salicylater (undtaget sulfasalazin), non-steroide antiinflammatoriske lægemidler (NSAID'er), smertestillende midler eller methotrexat.
English: • Do not touch this area again before giving the injection.
Danish: • Du må ikke røre stedet igen, inden du injicerer.
English: • Do not use the solution if it is discoloured, cloudy, or if particles other than those described above are present.
Danish: • Du må ikke bruge opløsningen, hvis den er misfarvet eller uklar, eller hvis den indeholder andre partikler end dem, der er beskrevet ovenfor.
English: Contents of the pack and other information What Benepali contains
Danish: Pakningsstørrelser og yderligere oplysninger Benepali indeholder:
English: In patients who develop HBV infection, Benepali should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Danish: Patienter, der udvikler HBV-infektion, bør stoppe behandlingen med Benepali og starte effektiv antiviral behandling med passende understøttende behandling.