FrancophonIA/ELRC3.0 huggingface dataset:
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts handelsnavn og batchnummer tydeligt registreres(eller angives) i patientjournalen.
English: No information is available if the use of Benepali effects the ability to drive or use machines.
Danish: Der findes ingen oplysninger, om brugen af Benepali påvirker evnen til at føre motorkøretøj eller betjene maskiner.
English: If you feel that the effect of Benepali is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du føler, at virkningen af Benepali er for stærk eller for svag, skal du kontakte din læge eller apotekspersonalet.
English: However, the occurrence was rare, and the follow-up period of placebo patients was shorter than for patients receiving TNF-antagonist therapy.
Danish: Forekomsten var dog sjælden, og opfølgningstiden for placebo-patienter var kortere end for patienter, der fik TNF-antagonistbehandling.
English: Patients who develop a new infection while undergoing treatment with Benepali should be monitored closely.
Danish: Patienter, som udvikler en ny infektion, mens de er i behandling med Benepali, bør overvåges nøje.
English: Talk to your doctor before taking Benepali.
Danish: Kontakt lægen, før du tager Benepali.
English: The Patient Alert Card should contain the following key elements for patients treated with Benepali:
Danish: Patientkortet skal indeholde følgende vigtige elementer for patienter, der behandles med Benepali:
English: Administration of Benepali should be discontinued if a patient develops a serious infection.
Danish: Indgivelse af Benepali skal ophøre, hvis en patient udvikler en alvorlig infektion.
English: Allergic reactions have included angioedema and urticaria; serious reactions have occurred.
Danish: Allergiske reaktioner har inkluderet angioødem og urticaria, alvorlige reaktioner er forekommet.
English: It is recommended that you record the date that Benepali is removed from the refrigerator and the date after which Benepali should be discarded (no more than 4 weeks following the removal from the refrigerator).
Danish: Det anbefales, at du noterer den dato, hvor Benepali tages ud af køleskabet, og den dato, hvor Benepali skal kasseres (højst 4 uger efter, at det er taget ud af køleskabet).
English: Thus, it is not possible to administer Benepali to paediatric patients that require less than a full 25 mg or 50 mg dose.
Danish: Det er derfor ikke muligt at administrere Benepali til pædiatriske patienter, der har behov for mindre end en fuld 25 mg- eller 50 mg-dosis.
English: - Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with Benepali.
Danish: - Din læge vil give dig et 'Patientkort', som indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på, før og under behandlingen med Benepali.
English: Because immunoglobulins, in common with many medicinal products, can be excreted in human milk, a decision must be made whether to discontinue breast-feeding or to discontinue Benepali therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Da immunglobuliner lige som mange andre lægemidler kan udskilles i human mælk, skal det besluttes, om amning skal ophøre eller behandling med Benepali seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Children and adults taking Benepali may have an increased risk of developing lymphoma or another cancer.
Danish: Børn og voksne, som får Benepali, kan have øget risiko for at udvikle kræft i lymfesystemet eller andre former for kræft.
English: The effect of etanercept on radiographic progression was maintained in patients who continued on treatment during the second year.
Danish: Etanercepts effekt på den røntgenologiske progression blev fastholdt hos de patienter, som fortsatte med behandling i løbet af det andet år.
English: No dose adjustment is required.
Danish: Der kræves ingen dosisjustering.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke udført studier om påvirkningen af evnen til at føre motorkøretøj og betjene maskiner.
English: Tell your doctor or pharmacist if you or the child are taking, have recently taken or might take any other medicines (including sulfasalazine), even those not prescribed by your doctor.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du eller barnet tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin (herunder sulfasalazin), også medicin, der ikke er ordineret af din læge.
English: Etanercept was significantly better than placebo in all measures of disease activity (p < 0.001), and responses were similar with and without concomitant methotrexate therapy.
Danish: Etanercept var signifikant bedre end placebo på alle mål for sygdomsaktivitet (p < 0,001), og responset var det samme med og uden samtidig methotrexat-behandling.
English: The incidence of non-cutaneous malignancies of various types was significantly higher in patients treated with etanercept than in the control group.
Danish: Hyppigheden af ikke-kutane maligniteter af forskellig type var signifikant højere hos patienter behandlet med etanercept end i kontrolgruppen.
English: • Infections/monitoring: Tell your doctor of any recent travel outside the European region.
Danish: • Infektioner/overvågning: Fortæl det til lægen, hvis du for nylig har rejst uden for Europa.
English: A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg. Etanercept was significantly better than placebo in all components of the ACR criteria, as well as other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.
Danish: Man så et dosisrespons: resultater med 10 mg lå mellem placebo og 25 mg. Etanercept var betydeligt bedre end placebo i alle dele af ACR-kriterierne såvel som andre mål for sygdomsaktiviteten af reumatoid artrit, der ikke er medtaget i ACRresponskriterierne, som f.eks. morgenstivhed.
English: During the first 12 weeks of the double-blind treatment period, patients received placebo or one of the above three etanercept doses.
Danish: I de første 12 uger af den dobbeltblinde behandlingsperiode fik patienterne placebo eller en af ovennævnte tre etanerceptdoser.
English: Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher than average risk of developing lymphoma.
Danish: Patienter med alvorlig reumatoid artrit, som har haft sygdommen i lang tid, kan have større risiko end gennemsnittet for at udvikle kræft i lymfesystemet.
English: There have been rare reports of patients, including rheumatoid factor positive patients, who have developed other autoantibodies in conjunction with a lupus-like syndrome or rashes that are compatible with subacute cutaneous lupus or discoid lupus by clinical presentation and biopsy.
Danish: Der har været sjældne rapporter om patienter, herunder rheumatoid faktor positive patienter, som har udviklet andre autoantistoffer i forbindelse med lupus-lignende syndrom eller udslæt, som er kompatibel med subakut kutan lupus eller diskoid lupus ved klinisk præsentation og biopsi.
English: *Some patients did not provide complete data for each endpoint **ASAS=Assessments in Spondyloarthritis International Society ***Bath Ankylosing Spondylitis Disease Activity Index a: p < 0.001, b: < 0.01 and c: < 0.05, respectively between etanercept and placebo
Danish: *Nogle patienter leverede ikke fuldstændige data for alle endepunkter **ASAS=Assessments in Spondyloarthritis International Society ***Bath Ankylosing Spondylitis Disease Activity Index a: p < 0,001, b: < 0,01 og c: < 0,05 mellem henholdsvis etanercept og placebo
English: In long-term (up to 34 months) open-label studies where etanercept was given without interruption, clinical responses were sustained and safety was comparable to shorter-term studies.
Danish: I åbne langtidsstudier (op til 34 måneder), hvor etanercept blev givet uden afbrydelser, blev det kliniske respons opretholdt, og sikkerheden var den samme som i korttidsstudier.
English: The long-term safety of etanercept in combination with other disease-modifying antirheumatic drugs (DMARD) has not been established.
Danish: Sikkerheden på lang sigt ved etanercept-behandling i kombination med andre sygdomsmodificerende antireumatiske lægemidler (DMARD'er) er ikke fastslået.
English: Abbreviation: sPGA-static Physician Global Assessment a p < 0.0001 compared with placebo
Danish: Forkortelse: sPGA: static Physician Global Assessment a p < 0,0001 sammenlignet med placebo
English: Component of a multipack, cannot be sold separately
Danish: Del af multipakning, må ikke sælges separat
English: It should be injected into the thigh, abdomen, or back of the upper arm (see image on the left).
Danish: Lægemidlet skal injiceres i låret, maven eller på undersiden af overarmen (se billedet til venstre).
English: Benepali can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Danish: Benepali kan gives som monoterapi i tilfælde af intolerance over for methotrexat, eller hvis fortsat behandling med methotrexat er uhensigtsmæssig.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: Etanercept has not been studied in children aged less than 2 years.
Danish: Etanercept er ikke undersøgt hos børn under 2 år.
English: For patients with multiple symmetrical painful or swollen joints (e.g., hands, wrists and feet), Benepali can slow down the structural damage to those joints caused by the disease.
Danish: Hos patienter med flere symmetriske, smertefulde eller opsvulmede led (f.eks. hænder, håndled og fødder) kan Benepali nedsætte hastigheden, hvormed leddenes struktur ødelægges på grund af sygdommen.
English: Etanercept 0.8 mg/kg Once Weekly (N = 106)
Danish: Etanercept 0,8 mg/kg 1 gang om ugen (N = 106)
English: This may include a thorough medical history, a chest X-ray and a tuberculin test.
Danish: Undersøgelsen kan omfatte en grundig gennemgang af din helbredstilstand, røntgenbillede af brystkassen og en tuberkulinundersøgelse.
English: Vasculitis (including antineutrophilic cytoplasmic antibody positive vasculitis)
Danish: Vaskulitis (inklusive antineutrofil cytoplasmatisk antistof-positiv vaskulitis)
English: The conduct of these tests should be recorded on the Patient Alert Card.
Danish: Udførelsen af disse prøver skal noteres på dit 'Patientkort'.
English: During the withdrawal period, symptoms of psoriasis gradually returned, with a median time to disease relapse of 3 months.
Danish: I den behandlingsfrie periode vendte symptomerne på psoriasis gradvist tilbage med en mediantid til sygdomsrecidiv på 3 måneder.
English: • For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked well enough or is not suitable for them:
Danish: • Til følgende typer af juvenil idiopatisk artrit (børnegigt), hvor behandling med methotrexat har været utilstrækkelig eller ikke kan anvendes:
English: Etanercept showed statistically significantly greater improvement from baseline to week 12 compared to placebo in most health-related quality of life and physical function assessments, including BASFI (Bath Ankylosing Spondylitis Functional Index), EuroQol 5D Overall Health State Score and SF-36 Physical Component Score.
Danish: Etanercept viste en statistisk signifikant større forbedring fra baseline til uge 12 sammenlignet med placebo i de fleste helbredsrelaterede vurderinger af livskvalitet og fysisk funktion, herunder BASFIfunktionsindekset (Bath Ankylosing Spondylitis Functional Index) og EuroQol 5D-spørgeskemaerne Overall Health State Score og SF-36 Physical Component Score.
English: This study also showed no increased risks of minor birth defects, preterm birth, stillbirth, or infections in the first year of life for infants born to women exposed to etanercept during pregnancy.
Danish: Studiet viste heller ingen øget risiko for mindre alvorlige fødselsdefekter, for tidlig fødsel, dødfødsel eller infektioner i det første år for børn, der er født af kvinder eksponeret for etanercept under graviditeten.
English: Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with etanercept for up to 48 months.
Danish: Alvorlige infektioner forekom hos 6,3 % af patienterne med reumatoid artrit, som blev behandlet med etanercept i op til 48 måneder.
English: Components inside the pre-filled pen may be broken.
Danish: Indvendige dele i den fyldte pen kan være gået i stykker.
English: Treatment with etanercept 25 mg resulted in substantial improvement at 12 months, with about 44% of patients achieving a normal HAQ score (less than 0.5).
Danish: Behandling med etanercept 25 mg resulterede i betydelig bedring efter 12 måneder, hvor omkring 44 % af patienterne havde opnået en normal HAQ-score (mindre end 0,5).
English: 2 weeks
Danish: 2 uger
English: No clinically significant pharmacokinetic drug-drug interactions were observed in studies with methotrexate, digoxin or warfarin.
Danish: Der blev ikke observeret nogen klinisk betydende, farmakokinetiske lægemiddellægemiddelinteraktioner i studier med methotrexat, digoxin og warfarin.
English: All subdomains of the HAQ were improved in patients treated with etanercept compared to controls at 3 and 6 months.
Danish: Alle underområder i HAQ'et blev forbedret hos patienter, der var behandlet med etanercept, ved 3 og 6 måneder sammenlignet med kontrolpersonerne.
English: For psoriatic arthritis patients with multiple joint involvement, Benepali can improve your ability to do normal daily activities.
Danish: Hos patienter med psoriasisgigt med flere angrebne led kan Benepali forbedre evnen til at udføre normale daglige aktiviteter.
English: However, your doctor may determine an alternative frequency at which to inject Benepali.
Danish: Lægen kan dog beslutte en anden hyppighed for injicering af Benepali.
English: Additionally, studies have not been conducted to assess the effects of discontinuing or reducing the recommended dose of etanercept following its long-term use in patients with JIA.
Danish: Desuden er der ikke gennemført studier til vurdering af virkningen af seponering af etanercept eller reduktion af den anbefalede dosis ved langvarig behandling af patienter med JIA.
English: Another study found no increased risk of birth defects when the mother had received etanercept in pregnancy.
Danish: Et andet studie fandt ingen øget risiko for fødselsdefekter, hvis moderen havde taget etanercept under graviditeten.
English: Then continue to inject the medicine on the usual day(s).
Danish: Fortsæt dernæst med at injicere din medicin på de sædvanlige dage.
English: Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Benepali.
Danish: Sådanne symptomer kan pege på tilstedeværelsen af en livstruende blodsygdom, som kan kræve, at behandling med Benepali ophører.
English: ● If you have congestive heart failure, and you think your symptoms (e.g., shortness of breath or swelling of the feet) are becoming worse, or you experience new onset of such symptoms, seek medical attention immediately.
Danish: ● Hvis du har hjertesvigt (kongestiv hjerteinsufficiens), og du mener, at dine symptomer (f.eks. åndenød eller hævede fødder) er blevet værre, eller du oplever et nyt tilfælde af sådanne symptomer, skal du straks søge læge.
English: In this situation, the benefit/risk balance of Benepali therapy should be very carefully considered.
Danish: I denne situation bør risk-benefit-forholdet ved behandlingen med Benepali overvejes meget nøje.
English: Your doctor will decide how long you should use Benepali and whether retreatment is needed based on your response.
Danish: Lægen vil afgøre, hvor længe du skal anvende Benepali, og om gentagen behandling er nødvendig, afhængig af hvordan du reagerer på behandlingen.
English: No treatment was given for the majority of injection site reactions in the etanercept treatment groups, and the majority of patients who were given treatment received topical preparations, such as corticosteroids, or oral antihistamines.
Danish: Der blev ikke givet nogen behandling for størstedelen af injektionsstedsreaktioner hos etanercept-behandlingsgrupperne, og størstedelen af de patienter, som fik behandling, modtog topiske præparater som for eksempel kortikosteroider eller antihistaminer til oral indtagelse.
English: There have been reports of hypoglycaemia following initiation of etanercept in patients receiving medicinal products for diabetes, necessitating a reduction in anti-diabetic medicinal products in some of these patients.
Danish: Der har været indberetninger om, at hypoglykæmi er opstået, efter behandling med etanercept er påbegyndt hos patienter, der får lægemidler mod diabetes, hvilket har nødvendiggjort en nedsættelse af dosis af de anti-diabetiske lægemidler hos nogle af disse patienter.
English: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Danish: De følgende kategorier benyttes: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden
English: DSGAb, clear or almost clear * p ≤ 0.0001 compared with placebo a No statistical comparisons to placebo were made at week 24 in studies 2 and 4 because the original placebo group began receiving etanercept 25 mg BIW or 50 mg once weekly from week 13 to week 24. b Dermatologist Static Global Assessment.
Danish: DSGAb, klar eller næsten klar * p ≤ 0,0001 sammenlignet med placebo a Der blev ikke foretaget nogen statistisk sammenligning med placebo ved uge 24 i studie 2 og 4, fordi den oprindelige placebo-gruppe begyndte at få etanercept 25 mg to gange om ugen eller 50 mg én gang om ugen fra uge 13 til uge 24. b Dermatologist Static Global Assessment.
English: This includes reports of reactivation of hepatitis B in patients who were anti-HBc positive but HBsAg negative.
Danish: Dette omfatter rapporter om reaktivering af hepatitis B hos patienter, som var anti-HBcpositive, men HBsAg-negative.
English: Patients were observed off treatment for the occurrence of rebound (PASI ≥ 150% of baseline) and for the time to relapse (defined as a loss of at least half of the improvement achieved between baseline and week 24).
Danish: Patienterne blev observeret uden behandling for at se forekomsten af rebound (PASI ≥ 150% i forhold til baseline) og se tiden til recidiv (defineret som tab af mindst halvdelen af forbedringen opnået mellem baseline og uge 24).
English: In the toxicological studies with etanercept, no dose-limiting or target organ toxicity was evident.
Danish: I de toksikologiske studier med etanercept var der ingen tydelig dosisbegrænsning eller målorgantoksicitet.
English: In an open-label, safety extension study, 58 paediatric patients from the above study (from the age of 4 years at time of enrolment) continued to receive etanercept for up to 10 years.
Danish: I et åbent, udvidet sikkerhedsstudie fortsatte 58 pædiatriske patienter fra ovenstående studie (i alderen fra 4 år ved studiestart) med at få etanercept i op til 10 år.
English: Autoantibody formation Treatment with Benepali may result in the formation of autoimmune antibodies (see section 4.8).
Danish: Dannelse af autoantistof Behandling med Benepali kan resultere i dannelse af autoimmunantistoffer (se pkt.
English: Etanercept did not induce lethality or notable signs of toxicity in mice or rats following a single subcutaneous dose of 2,000 mg/kg or a single intravenous dose of 1,000 mg/kg.
Danish: Etanercept forårsagede ikke letalitet eller genkendelige tegn på toksicitet hos mus eller rotter efter en enkelt subkutan dosis på 2.000 mg/kg eller en enkelt intravenøs dosis på 1.000 mg/kg.
English: There have been reports of worsening of hepatitis C in patients receiving etanercept.
Danish: Der er indberetninger om forværring af hepatitis C hos patienter i behandling med etanercept.
English: A Health Assessment Questionnaire (HAQ), which included disability, vitality, mental health, general health status, and arthritis-associated health status subdomains, was administered every 3 months during the trial.
Danish: Der blev besvaret et spørgeskema om helbredstilstand (HAQ, Health Assessment Questionnaire), omfattende handicap, vitalitet, mentalhygiejne, generel sundhedstilstand og helbredsstatus for artrit-afhængige underområder hver 3. måned under studiet.
English: Of patients who demonstrated a clinical response at 90 days and entered part 2 of the study, some of the patients remaining on etanercept continued to improve from month 3 through month 7, while those who received placebo did not improve.
Danish: Af de patienter, som viste klinisk respons efter 90 dage og indgik i anden del af studiet, fortsatte forbedringen hos nogle af de patienter, som fortsatte med etanercept, fra måned 3 til måned 7, mens de, der fik placebo, ikke blev bedre.
English: Radiographic progression at 12 months was significantly less in the etanercept group than in the methotrexate group, while the combination was significantly better than either monotherapy at slowing radiographic progression (see figure below).
Danish: Radiografisk progression var signifikant mindre i etanercept-gruppen end i methotrexat-gruppen ved 12 måneder, hvorimod kombinationen var signifikant bedre end begge monoterapier til at forsinke radiografisk progression (se nedenstående figur).
English: • Do not move the pre-filled pen during the injection.
Danish: • Du må ikke flytte den fyldte pen under injektionen.
English: The use of etanercept in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied.
Danish: Brugen af etanercept i kombination med andre systemiske behandlinger eller med lysbehandling til behandling af psoriasis er ikke undersøgt.
English: Carcinogenicity studies, and standard assessments of fertility and postnatal toxicity, were not performed with etanercept due to the development of neutralising antibodies in rodents.
Danish: Karcinogenitetsstudier samt standardvurderinger af fertilitet og postnatal toksicitet blev ikke udført med etanercept på grund af udvikling af neutraliserende antistoffer hos gnavere.
English: • If you have psoriasis, do not inject into any raised, thick, red, or scaly skin patches, or lesions.
Danish: • Hvis du har psoriasis, må du ikke injicere på hævede, tykke, røde eller skællende hudområder eller på områder med læsioner.
English: Position the pre-filled pen approximately 90 degrees to the skin.
Danish: Anbring den fyldte pen i en vinkel på ca. 90 grader i forhold til huden.
English: Benepali is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Danish: Benepali er også indiceret til behandling af alvorlig, aktiv og progressiv reumatoid artrit hos voksne, som ikke tidligere har været behandlet med methotrexat.
English: Etanercept n = 103 to 105*
Danish: Etanercept n = 103 til 105*
English: The needle guard will completely cover the needle.
Danish: Kanylehætten dækker kanylen fuldstændigt.
English: Common to < 1/10
Danish: Almindelig to < 1/10
English: Disease flare was defined as a 30% worsening in three of six JRA core set criteria and 30% improvement in not more than one of the six JRA core set criteria and a minimum of two active joints.
Danish: Sygdomsopblussen blev defineret som en 30 % forværring af tre af seks JRA-kernekriterier og 30 % forbedring i højst en af seks JRA kernekriterier, og mindst to aktive led.