FrancophonIA/ELRC3.0 huggingface dataset:
English: Out of 146 patients who were randomised to Simponi 50 mg, 52 week X-ray data were available for 126 patients, of whom 77% showed no progression compared to baseline.
Danish: Ud af 146 patienter, som var randomiseret til Simponi 50 mg, var røntgendata tilgængelige for 126 patienter ved uge 52, hvoraf 77% viste ingen progression sammenlignet med baseline.
English: Psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis Simponi 50 mg given once a month, on the same date each month.
Danish: Psoriasisartrit, ankyloserende spondylit eller non-radiografisk aksial spondylartrit Simponi 50 mg indgives en gang om måneden på den samme dato hver måned.
English: Dose selections: 0.1 mL
Danish: Dosisvalg: 0,1 ml
English: The combination of golimumab with other biological therapeutics used to treat the same conditions as golimumab, including anakinra and abatacept is not recommended (see section 4.4).
Danish: Kombination af golimumab og andre biologiske lægemidler til behandling af de samme lidelser som golimumab, herunder anakinra og abatacept, anbefales ikke (se pkt.
English: The safety and efficacy of golimumab have not been established in patients with pJIA below the age of 2 years.
Danish: Golimumabs sikkerhed og virkning er ikke klarlagt hos patienter med pJIA, der er under 2 år.
English: • Chronic inflammatory condition of the lungs
Danish: • Kronisk betændelsestilstand i lungerne
English: • The second ‘click' means that the injection is finished and the needle has gone back into the pre-filled pen.
Danish: • Det andet “klik” betyder, at indsprøjtningen er færdig, og at nålen igen er tilbage i den fyldte pen.
English: Use of anti-tuberculosis therapy should also be considered before the initiation of golimumab in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Danish: Anvendelsen af anti-tuberkulosebehandling bør også overvejes før initieringen af golimumab hos patienter med latent eller aktiv tuberkulose i anamnesen, hos hvem et passende behandlingsprogram ikke kan bekræftes.
English: The majority of cases have occurred in adolescent and young adult males with nearly all on concomitant treatment with azathioprine (AZA) or 6-mercaptopurine (6-MP) for inflammatory bowel disease.
Danish: De fleste tilfælde er set hos unge og yngre voksne mænd, hvoraf næsten alle var i samtidig behandling med azathioprin (AZA) eller 6-mercaptopurin (6-MP) for inflammatorisk tarmsygdom.
English: • Treatment with TNF blockers such as Simponi may result in reactivation of HBV in patients who carry this virus, which can be life-threatening in some cases.
Danish: • Behandling med TNF-blokkere, såsom Simponi, kan medføre, at HBV igen bliver aktiv hos patienter, som bærer denne virus.
English: Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.
Danish: Simponi er indiceret til behandling af svær, aktiv ankyloserende spondylit hos voksne, som har reageret utilstrækkeligt på konventionel behandling.
English: • That treatment with Simponi may increase the risks of serious infection, opportunistic infections, tuberculosis, hepatitis B reactivation and breakthrough infection after administration of live vaccines in infants exposed to golimumab in utero; and when to seek attention from a
Danish: • Information om at behandling med Simponi kan øge risikoen for alvorlige infektioner, opportunistiske infektioner, tuberkulose, reaktivering af hepatitis B og gennembrudsinfektion efter administration af levende vacciner hos spædbørn, der i uterus er blevet eksponeret for golimumab; og information om, hvornår patienten skal søge hjælp hos en sundhedsperson.
English: Patients should be closely monitored and golimumab must be discontinued in patients who develop new or worsening symptoms of heart failure (see section 4.3).
Danish: Patienter bør følges nøje, og behandling med golimumab skal afbrydes hos patienter, som udvikler nye eller forværrede symptomer på hjerteinsufficiens (se pkt.
English: Simponi, in combination with methotrexate (MTX), is indicated for:
Danish: Reumatoid artrit (RA) Simponi er i kombination med methotrexat (MTX) indiceret til:
English: The use of golimumab in pregnant women is not recommended; golimumab should be given to a pregnant woman only if clearly needed.
Danish: Golimumab anbefales ikke til gravide; golimumab bør kun gives til gravide på tvingende indikation.
English: The binding of human TNF by golimumab was shown to neutralise TNF-α-induced cell-surface expression of the adhesion molecules E-selectin, vascular cell adhesion molecule (VCAM)-1 and intercellular adhesion molecule (ICAM)-1 by human endothelial cells.
Danish: Det er påvist, at binding af human TNF ved hjælp af golimumab neutraliserer TNFα-induceret ekspression af adhæsionsmolekylerne E-selectin, vascular cell adhesion molecule (VCAM)-1 og intercellular adhesion molecule (ICAM)-1 på overfladen af humane endotelceller.
English: Although concomitant use of MTX results in higher steady-state trough concentrations of golimumab in patients with RA, PsA or AS, the data do not suggest the need for dose adjustment of either golimumab or MTX (see section 5.2).
Danish: Selvom samtidig behandling med MTX resulterer i en højere steady-state-dalkoncentration af golimumab hos patienter med RA, PsA eller AS, indikerer data ikke, at der er behov for dosisjusteringer af hverken golimumab eller MTX (se pkt.
English: Tell your doctor straight away if you get new or worsening symptoms of heart failure.
Danish: Fortæl det straks til din læge, hvis du får nye eller forværrede tegn på hjertesvigt.
English: Switching between biological disease modifying anti-rheumatic drugs (DMARDs) Care should be taken and patients should continue to be monitored when switching from one biologic to another, since overlapping biological activity may further increase the risk for adverse events, including infection.
Danish: Skift mellem biologiske sygdomsmodulerende, antireumatiske lægemidler (DMARDs) Der bør udvises forsigtighed, og patienterne skal fortsat monitoreres ved skift fra et biologisk lægemiddel til et andet, da overlappende biologisk aktivitet kan øge risikoen for bivirkninger yderligere, herunder for infektioner.
English: Concomitant stable doses of oral aminosalicylates, and/or immunomodulatory agents were permitted.
Danish: Samtidige stabile doser af orale aminosalicylater og/eller immunmodulerende lægemidler var tilladt.
English: • Infections may progress more rapidly and may be more severe.
Danish: • Disse infektioner kan udvikle sig hurtigere og være mere alvorlige end ellers.
English: Neoplasms, benign, malignant and unspecified
Danish: Benigne, maligne og uspecificerede tumorer
English: • Slowly take your thumb off the plunger head to allow the empty pre-filled syringe to move up until the entire needle is covered by the needle guard, as shown by the figure 9:
Danish: • Fjern langsomt din tommelfinger fra stemplet, for at den tomme sprøjte kan få lov til at bevæge sig op, indtil hele nålen er dækket af kappen, som vist på figur 9:
English: Do not warm the pre-filled syringe in any other way (for example, do not warm it in a microwave or in hot water).
Danish: Varm ikke den fyldte injektionssprøjte på andre måder (fx må den ikke varmes i en mikrobølgeovn eller i varmt vand).
English: For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of golimumab treatment should be carefully considered before initiation of golimumab therapy.
Danish: For patienter, som har boet eller rejst i områder, hvor invasive svampeinfektioner såsom histoplasmose, kokcidioidomykose eller blastomykose er endemiske, bør fordele og risici ved golimumab-behandling overvejes omhyggeligt, før golimumab-behandling initieres.
English: • You can also use the stomach (abdomen) below the belly button, except for approximately the 5 cm area directly underneath the belly button.
Danish: • Du kan også anvende maven (abdomen) under navlen, undtagen i området ca. 5 cm lige under navlen.
English: • the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate.
Danish: • Behandling af moderat til svær, aktiv, reumatoid artrit hos voksne patienter, når responset på sygdomsmodulerende, antireumatiske lægemidler (DMARDs), inklusive MTX, har været utilstrækkeligt.
English: Patients with body weight greater than 100 kg
Danish: Patienter med kropsvægt over 100 kg
English: Further treatment with golimumab must not be given if a patient develops a serious infection or sepsis (see section 4.3).
Danish: Behandling med golimumab må ikke fortsættes, hvis en patient udvikler en alvorlig infektion eller sepsis (se pkt.
English: CARTON FOR MULTIPACK COMPRISING 3 PACKS (INCLUDING BLUE BOX)
Danish: KARTON MULTIPAKKE INDEHOLDENDE 3 PAKKER (MED BLUE BOX)
English: Patients in clinical remission at week 6
Danish: Patienter med klinisk remission i uge 6
English: Check the liquid in the viewing window.
Danish: Kontroller væsken i inspektionsvinduet.
English: Approximately 63% of patients who were receiving Simponi at the beginning of the study extension (week 56), remained on treatment through the end of the study (last golimumab administration at week 212).
Danish: Ca. 63% af patienterne, som fik Simponi i starten af studieforlængelsen (uge 56), forblev i behandling til og med afslutningen af studiet (sidste administration af golimumab ved uge 212).
English: Patients treated with Simponi experienced significantly more improvements in health-related quality of life as assessed by ASQoL, EQ-5D, and physical and mental components of SF-36, and experienced significantly more improvements in productivity as assessed by greater reductions in overall work impairment and in activity impairment as assessed by the WPAI questionnaire than patients receiving placebo.
Danish: Patienter, der var blevet behandlet med Simponi, oplevede signifikant flere forbedringer i helbredsrelateret livskvalitet, vurderet ved ASQoL, EQ-5D samt fysiske og mentale komponenter af SF-36, og oplevede signifikant flere forbedringer i ydeevne vurderet ved større forbedring i nedsat arbejdsevne totalt set og i nedsat aktivitetsniveau vurderet ved WPAI-spørgeskemaet end patienter, der fik placebo.
English: Ulcerative colitis is an inflammatory disease of the bowel.
Danish: Colitis ulcerosa er en betændelsessygdom i tarmen.
English: • Do not put the cap back on because it may damage the needle inside the pre-filled pen.
Danish: • Sæt ikke hætten på igen, da den kan ødelægge nålen inde i den fyldte pen.
English: Based on the subset of patients with ≥ 3% BSA involvement at baseline, 79 patients (69.9%) in the placebo group and 109 (74.3%) in the Simponi 50 mg group.
Danish: Baseret på undergruppen af patienter med ≥ 3% BSA involveret ved baseline, 79 patienter (69,9%) i placebogruppen og 109 (74,3%) i Simponi 50 mg-gruppen.
English: Cases of active tuberculosis have occurred in patients treated with golimumab during and after treatment for latent tuberculosis.
Danish: Der er set tilfælde af aktiv tuberkulose hos patienter i behandling med golimumab under og efter behandling af latent tuberkulose.
English: However, caution should be exercised when treating the elderly and particular attention paid with respect to occurrence of infections.
Danish: Der bør udvises forsigtighed ved behandling af ældre patienter, især med hensyn til forekomst af infektioner.
English: Golimumab should be used with caution in patients with mild heart failure (NYHA class I/II).
Danish: Golimumab bør anvendes med forsigtighed hos patienter med mild hjerteinsufficiens (NYHA-funktionsklasse I/II).
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor).
Danish: Det anbefales, at alle patienter straks bør søge lægehjælp, hvis de udvikler sygdomstegn og symptomer på bloddyskrasi (fx vedvarende feber, blå mærker, blødning, bleghed).
English: Based on the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF-antagonist cannot be excluded.
Danish: Baseret på den nuværende viden kan en mulig risiko for udvikling af lymfomer, leukæmi eller andre maligne sygdomme hos patienter behandlet med et TNF-blokerende middel ikke udelukkes.
English: Distribution Following a single IV administration, the mean volume of distribution was 115  19 mL/kg.
Danish: Fordeling Efter en enkelt i.v.-injektion var det gennemsnitlige fordelingsvolumen 115 ± 19 ml/kg.
English: DO NOT press the button at this time.
Danish: Tryk IKKE på knappen endnu.
English: After disease flare, children received Simponi 30 mg/m2 (maximum 50 mg) + MTX.
Danish: Efter opblussen af sygdommen fik børnene Simponi 30 mg/m2 (højst 50 mg) + MTX.
English: The efficacy of Simponi through week 54 was assessed in this study.
Danish: Simponis virkning til og med uge 54 blev vurderet i dette studie.
English: Symptoms of skin cancer can include changes in the appearance of your skin or growths on your skin.
Danish: Symptomer på hudkræft kan være ændringer i hudens udseende eller vækster på huden.
English: • The cap should not be removed until you are ready to inject the medicine.
Danish: • Hætten må ikke fjernes, før du er klar til at indsprøjte medicinen.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age) in the post marketing setting.
Danish: Der er set maligniteter, hvoraf nogle har været dødelige, hos børn, unge og unge voksne (op til 22 år), som er behandlet med TNF-blokerende midler (behandlingsstart før 18-års alderen) efter markedsføringen.
English: Week 24 14% 37%* Week 52 NA NA NA
Danish: Uge 24 14% 37%* Uge 52 NA NA NA
English: Patients enrolled in this study had active disease (defined as a BASDAI ≥ 4 and a Visual Analogue Scale (VAS) for total back pain of ≥ 4, each on a scale of 0-10 cm) despite current or previous NSAID therapy and had not previously been treated with any biological agents including anti-TNF therapy.
Danish: De patienter, der deltog i dette studie, havde aktiv sygdom (defineret som BASDAI ≥ 4 og VAS for total rygsmerte ≥ 4, hver på en skala på 0-10 cm) på trods af aktuel eller tidligere NSAID-behandling og havde ikke tidligere fået behandling med biologiske lægemidler herunder anti-TNF-behandling.
English: • serious infections (including TB, bacterial infections including serious blood infections and pneumonia, severe fungal infections and other opportunistic infections) (common).
Danish: • Alvorlige infektioner (inklusive TB, bakterieinfektioner, herunder alvorlige blodinfektioner og lungebetændelse, alvorlige svampeinfektioner og andre opportunistiske infektioner (almindelige).
English: • Eye allergy
Danish: • Øjenallergi
English: Do not rub your skin.
Danish: Gnid ikke på huden.
English: Do not return this medicine to refrigerator if it has reached room temperature.
Danish: Lægemidlet må ikke sættes tilbage på køl igen, hvis det har opnået stuetemperatur.
English: The frequency of anti-dsDNA antibodies at 1 year of follow-up in patients anti-dsDNA negative at baseline was 1.1%.
Danish: Ved 1 års follow-up var hyppigheden af anti-dsDNA-antistoffer 1,1% hos patienter, der var anti-dsDNA-negative ved baseline.
English: • Tell your doctor if you think you might be at risk of contracting HBV
Danish: • Fortæl det til din læge, hvis du tror, at du har en risiko for at få HBV.
English: A risk for the development of malignancies in children and adolescents treated with TNF-blockers cannot be excluded.
Danish: En risiko for udvikling af maligniteter hos børn og unge i behandling med TNF-blokkere kan ikke udelukkes.
English: At week 16, 34% of children had inactive disease defined as having the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalised lymphadenopathy attributable to JIA; no active uveitis; normal ESR (< 20 mm/hour) or CRP (< 1.0 mg/dL); physician global assessment of disease activity (≤ 5 mm on the VAS); duration of morning stiffness < 15 minutes.
Danish: Ved uge 16 havde 34% af børnene inaktiv sygdom defineret som tilstedeværelse af alle følgende komponenter: ingen led med aktiv artrit; ingen feber, udslæt, serosit, splenomegali, hepatomegali eller generaliseret lymfadenopati på grund af JIA; ingen aktiv uveit; normal SR (< 20 mm/time) eller CRP (< 1,0 mg/dl); lægers globale vurdering af sygdomsaktivitet (≤ 5 mm på VAS-skalaen); varighed af morgenstivhed < 15 minutter.
English: Press button to inject (see figure 7)
Danish: Tryk på knappen for indsprøjtning (se figur 7)
English: Initial treatment
Danish: Behandlingsstart
English: Concurrent administration with other biological therapeutics There is insufficient information regarding the concomitant use of golimumab with other biological therapeutics used to treat the same conditions as golimumab.
Danish: Samtidig administration af anden biologisk behandling Der foreligger ikke tilstrækkelig information om samtidig brug af golimumab og andre biologiske lægemidler til behandling af de samme lidelser som golimumab.
English: There have been reports of pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anaemia, and thrombocytopenia in patients receiving TNF-blockers, including golimumab.
Danish: Der er blevet rapporteret pancytopeni, leukopeni, neutropeni, agranulocytose, aplastisk anæmi og trombocytopeni hos patienter, der fik TNF-blokkere, herunder golimumab.
English: Do not rub the injection site.
Danish: Undlad at gnide på indsprøjtningsstedet.
English: Simponi is registered in 50 mg and 100 mg strengths for subcutaneous administration.
Danish: Simponi er registreret i styrkerne 50 mg og 100 mg til subkutan administration.
English: • Check the expiration date (as indicated as “EXP”) on the pre-filled pen.
Danish: • Tjek udløbsdatoen (angivet som “EXP”) på den fyldte pen.
English: The needle cover should not be removed until you are ready to inject the medicine.
Danish: Nålebeskyttelseshætten må ikke fjernes, før du er klar til at indsprøjte medicinen.
English: Check the number of pre-filled pens Check the pre-filled pens to make sure
Danish: Tjek antallet af fyldte penne Tjek de fyldte penne for at sikre, at
English: Moderate or severe heart failure (NYHA class III/IV) (see section 4.4).
Danish: Patienter med moderat eller svært hjertesvigt (NYHA-funktionsklasse III/IV) (se pkt.
English: The pen or the syringe should not be shaken.
Danish: Pennen eller injektionssprøjten må ikke rystes.
English: Change from baseline
Danish: Ændring fra baseline
English: • Lift the pre-filled pen from the injection site.
Danish: • Løft den fyldte pen fra indsprøjtningsstedet.
English: Make sure you dispose of the bin as instructed by your doctor or nurse when the container is full.
Danish: Sørg for at bortskaffe beholderen som instrueret af din læge eller sygeplejerske, når nålebeholderen er fuld.
English: The new expiry date must be written on the carton (up to 30 days from the date removed from the refrigerator).
Danish: Den nye udløbsdato skal skrives på kartonen (op til 30 dage efter datoen for udtagning fra køleskab).
English: Among patients who received Simponi maintenance treatment, the improvement in quality of life as measured by IBDQ was maintained through week 54.
Danish: Blandt de patienter, som fik Simponi vedligeholdelsesbehandling, blev forbedringen af livskvaliteten målt ved IBDQ opretholdt til og med uge 54.
English: Similar ACR 20 responses at week 14 were observed in patients with polyarticular arthritis with no rheumatoid nodules and asymmetric peripheral arthritis PsA subtypes.
Danish: Sammenlignelige ACR 20-respons blev observeret i uge 14 hos patienter med polyartikulær artrit uden reumatoide noduli og asymmetrisk perifer artrit PsA-subtyper.
English: • Before starting breast-feeding, your last treatment with Simponi must be at least 6 months ago.
Danish: • Før du starter med at amme, skal det være mindst 6 måneder siden, du fik din sidste behandling med Simponi.
English: • Wipe the injection site with an alcohol swab.
Danish: • Tør indsprøjtningsstedet med en alkoholserviet.
English: • Pull the cap off and throw it away after your injection.
Danish: • Træk hætten af og smid den ud efter indsprøjtningen.
English: • Check the security seal around the cap of the pre-filled pen.
Danish: • Tjek sikkerhedsforseglingen rundt om hætten på den fyldte pen.
English: Golimumab is a human monoclonal antibody that forms high affinity, stable complexes with both the soluble and transmembrane bioactive forms of human TNF-α, which prevents the binding of TNF-α to its receptors.
Danish: Golimumab er et humant monoklonalt antistof, der binder sig med høj affinitet til både opløselige og transmembrane former af TNF, hvilket forhindrer binding af TNFα til dens receptorer.
English: • You may notice an air bubble in the pre-filled syringe or a drop of liquid at the end of the needle.
Danish: • Der kan være en luftboble i den fyldte injektionssprøjte eller en dråbe væske for enden af nålen.
English: • swelling of small blood vessels (vasculitis) (rare).
Danish: • Hævelse af de små blodkar (vaskulitis) (sjælden).
English: The pharmacokinetics of golimumab were determined in 173 children with pJIA with an age range from 2 to 17 years of age.
Danish: Golimumabs farmakokinetik blev bestemt hos 173 børn i alderen 2 til 17 år med pJIA.
English: Malignancies other than lymphoma
Danish: Maligne sygdomme andre end lymfomer
English: The diagram below (see figure 1) shows what the “SmartJect” pre-filled pen looks like.
Danish: Diagrammet nedenfor (se figur 1) viser, hvordan “SmartJect” fyldt pen ser ud.
English: At week 6, Simponi significantly improved quality of life as measured by change from baseline in a disease specific measure, IBDQ (inflammatory bowel disease questionnaire).
Danish: Ved uge 6 forbedrede Simponi livskvaliteten væsentligt målt ved ændring i forhold til baseline ved en sygdomsspecifik metode, Inflammatory Bowel Disease Questionnaire (IBDQ).
English: The majority of lymphomas occurred in study GO-AFTER, which enrolled patients previously exposed to anti-TNF agents who had longer disease duration and more refractory disease (see section 4.4).
Danish: Størstedelen af lymfomerne forekom i studiet GO-AFTER, som indrullerede patienter med tidligere eksponering for anti-TNF-stoffer, længere sygdomsvarighed og mere refraktær sygdom (se pkt.
English: At week 16, 87% of children were ACR Ped 30 responders, and 79%, 66%, and 36% of children were ACR Ped 50, ACR Ped 70, and ACR Ped 90 responders, respectively.
Danish: Ved uge 16 udviste 87% af børnene pædiatrisk ACR 30-respons, og henholdsvis 79%, 66% og 36% af børnene udviste pædiatrisk ACR 50-, 70- og 90-respons.
English: Placebo-controlled efficacy data were collected and analysed through week 24.
Danish: Placebo kontrollerede effekt data blev samlet og analyseret frem til uge 24.
English: Psoriatic arthritis (PsA)
Danish: Psoriasisartrit (PsA)
English: Use of TNF-blocking agents, including golimumab, has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and peripheral demyelinating disorders.
Danish: TNF-blokerende midler, inklusive golimumab, har i sjældne tilfælde været forbundet med nyopståede tilfælde af eller forværring af kliniske symptomer og/eller radiografiske tegn på demyeliniseringssygdomme i centralnervesystemet inklusive multipel sklerose og perifere demyeliniseringssygdomme.
English: Concomitant stable doses of oral aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted.
Danish: Samtidige stabile doser af orale aminosalicylater, kortikosteroider og/eller immunmodulerende lægemidler var tilladt.