FrancophonIA/ELRC3.0 huggingface dataset:
English: If you do not respond well enough to these medicines, you will be given Simponi in combination with methotrexate to treat the disease.
Danish: Hvis du ikke reagerer godt nok på disse lægemidler, vil du få Simponi i kombination med methotrexat til behandling af sygdommen.
English: • If you cannot see the expiration date through the viewing window, hold the pre-filled syringe by its body and rotate the needle cover to line up the expiration date to the viewing window.
Danish: • Hvis du ikke kan se udløbsdatoen gennem vinduet, kan du holde og dreje på kappen for at få udløbsdatoen til at være i vinduet.
English: • Balance disorders
Danish: • Balanceforstyrrelser
English: Patients receiving golimumab should be monitored closely for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis, patients who are on treatment for latent tuberculosis, or patients who were previously treated for tuberculosis infection.
Danish: Patienter, som får golimumab, skal følges tæt for tegn og symptomer på aktiv tuberkulose, herunder patienter, som er testet negative for latent tuberkulose, patienter i behandling for latent tuberkulose og patienter, som tidligere har været behandlet for tuberkulose.
English: Simponi or placebo were administered subcutaneously every 4 weeks.
Danish: Simponi eller placebo blev administreret subkutant hver 4. uge.
English: Autoimmune antibodies
Danish: Autoimmune antistoffer
English: • Do not touch the needle guard activation clips (as indicated by asterisks * in figure 1) to prevent prematurely covering the needle with the needle guard.
Danish: • Rør ikke ved nålebeskyttelsesaktiveringstappene (mærket med stjerne * i figur 1) for at undgå,
English: Population pharmacokinetic/pharmacodynamic modelling and simulation in children with pJIA confirmed the relationship between golimumab serum exposures and clinical efficacy and supports that the dosing regimen of golimumab 50 mg every 4 weeks in children with pJIA of at least 40 kg achieves similar exposures to those shown to be efficacious in adults.
Danish: Farmakokinetisk/farmakodynamisk populationsanalyse og simulering hos børn med pJIA bekræftede forholdet mellem serumeksponering af golimumab og klinisk effekt og understøtter, at der ved doseringsregimet for golimumab på 50 mg hver 4. uge hos børn med pJIA, der vejer mindst 40 kg, opnås samme eksponering, som er vist at være effektiv hos voksne.
English: In the controlled portions of clinical trials of all the TNF-blocking agents including golimumab, more cases of lymphoma have been observed among patients receiving anti-TNF treatment compared with control patients.
Danish: I de kontrollerede dele af kliniske studier med alle TNF-blokerende midler inklusive golimumab er der set flere tilfælde af lymfomer blandt patienter, som fik en TNF-blokker sammenlignet med patienter i kontrolgruppen.
English: Patients with RA, PsA or AS who did not receive concomitant MTX had approximately 30% lower steady-state trough concentrations of golimumab than those who received golimumab with MTX.
Danish: Patienter med RA, PsA eller AS, som ikke samtidig fik MTX, havde ca. 30% lavere steady-state-dalserumkoncentration af golimumab sammenlignet med dem, der fik MTX samtidigt.
English: AFTER
Danish: EFTER
English: Pre-specified subgroup analyses of the primary endpoint by baseline CRP (≥ 1 mg/dL vs < 1 mg/dL) demonstrated higher flare rates in placebo + MTX vs Simponi + MTX treated subjects among subjects with baseline CRP ≥ 1 mg/dL (87% vs 40% p = 0.0068).
Danish: En præ-specificeret undergruppeanalyse af det primære endepunkt i forhold til baseline CRP (≥ 1 mg/dl versus < 1 mg/dl) viste højere forekomst af opblussen af sygdommen i placebo + MTXgruppen versus Simponi + MTX-gruppen blandt forsøgspersoner med CRP ≥ 1 mg/dl ved baseline (87% versus 40%; p = 0,0068).
English: The diagram below (see figure 1) shows what the pre-filled syringe looks like.
Danish: Diagrammet nedenfor (se figur 1) viser, hvordan den fyldte injektionssprøjte ser ud.
English: For all of the above indications, available data suggest that clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses).
Danish: For alle ovennævnte indikationer tyder tilgængelige data på, at klinisk respons normalt opnås inden for 12 til 14 ugers behandling (efter 3-4 doser).
English: Statistically significant improvements in spinal mobility as assessed by BASMI (Bath Ankylosing Spondylitis Metrology Index) and in physical function as assessed by the BASFI were demonstrated in Simponi 50 mg-treated patients as compared to placebo-treated patients (p < 0.0001).
Danish: Der blev påvist statistisk signifikant bedring i spinal mobilitet vurderet ved BASMI (Bath Ankylosing Spondylitis Metrology Index) og i fysisk funktion vurderet ved BASFI hos patienter, der var blevet behandlet med Simponi 50 mg sammenlignet med patienter i placebogruppen (p < 0,0001).
English: However, you and your doctor may decide that you may inject Simponi yourself.
Danish: Du og dit læge kan dog beslutte, at du selv kan indsprøjte Simponi.
English: Patients should be instructed to inject the prescribed amount of Simponi according to the comprehensive instructions for use provided in the pack.
Danish: Patienterne skal instrueres i at injicere den ordinerede mængde Simponi i henhold til den detaljerede brugsvejledning, der er vedlagt i pakningen.
English: Table 5 Key efficacy outcomes from GO-RAISE.
Danish: Tabel 5 Nøgleresultater for effekt fra GO-RAISE
English: Common: Leukopenia (including neutropenia), anaemia Uncommon: Thrombocytopenia, pancytopenia Rare: Aplastic anaemia, agranulocytosis
Danish: Almindelig: Leukopeni (inklusive neutropeni), anæmi Ikke almindelig: Trombocytopeni, pancytopeni Sjælden: Aplastisk anæmi, agranulocytose
English: Very common: Upper respiratory tract infection (nasopharyngitis, pharyngitis, laryngitis and rhinitis)
Danish: Meget almindelig: Øvre luftvejsinfektion (nasofaryngit, faryngit, laryngit og rinit)
English: A part of the pre-filled pen, the needle cover, contains latex.
Danish: En del af den fyldte pen, beskyttelseshætten til nålen, indeholder latex.
English: 175 to < 180
Danish: 175 til < 180
English: Caution should be exercised when considering TNF-blocking therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop malignancy.
Danish: Når TNF-blokerende behandling overvejes, bør forsigtighed udvises hos patienter med maligne sygdomme i anamnesen, eller når fortsat behandling overvejes hos patienter, der udvikler maligne sygdomme.
English: Patients were randomly assigned to placebo, Simponi 50 mg and Simponi 100 mg and were allowed to continue concomitant DMARD therapy (MTX, SSZ and/or HCQ).
Danish: Patienterne blev randomiseret til placebo, Simponi 50 mg og Simponi 100 mg, og fik samtidig lov til at fortsætte behandling med DMARD (MTX, SSZ og/eller HCQ).
English: The 45 mg/0.45 mL pre-filled pen is for paediatric patients.
Danish: 45 mg/0,45 ml fyldt pen er til pædiatriske patienter.
English: Common: Allergic reactions (bronchospasm, hypersensitivity, urticaria), autoantibody positive Rare: Serious systemic hypersensitivity reactions (including anaphylactic reaction), vasculitis (systemic), sarcoidosis
Danish: Almindelig: Allergiske reaktioner (bronkospasmer, overfølsomhed, urticaria), positive autoantistoffer Sjælden: Alvorlige systemiske overfølsomhedsreaktioner (inklusive anafylaktisk reaktion), vaskulitis (systemisk), sarkoidose
English: The needle cover on the pre-filled pen or the pre-filled syringe is manufactured from dry natural rubber containing latex, and may cause allergic reactions in individuals sensitive to latex.
Danish: Nålebeskyttelseshætten på den fyldte pen eller den fyldte injektionssprøjte er fremstillet af tør naturgummi, som indeholder latex, og kan give allergiske reaktioner hos personer, der er overfølsomme for latex.
English: Symptoms of lymphoma can include swelling of the lymph nodes, weight loss, or fever.
Danish: Symptomer på lymfom kan være hævede lymfeknuder, vægttab eller feber.
English: • Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including any other medicines to treat polyarticular juvenile idiopathic arthritis.
Danish: • Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig, herunder medicin til behandling af polyartikulær juvenil idiopatisk artrit.
English: Specific studies of golimumab have not been conducted in patients with renal or hepatic impairment.
Danish: Der er ikke foretaget specifikke studier af golimumab hos patienter med nedsat nyre- eller leverfunktion.
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Simponi.
Danish: Hvis du er i tvivl, om noget af ovenstående passer på dig, skal du tale med din læge eller apotekspersonalet, før du tager Simponi.
English: • Look through the viewing window to make sure that the liquid in the pre-filled pen is clear to slightly opalescent (having a pearl-like shine) and colourless to light yellow.
Danish: • Se igennem vinduet for at sikre, at væsken i den fyldte pen er klar til let opaliserende (en perlelignende glans) og farveløs til lysegul.
English: Date _______________
Danish: Dato _______________
English: Choose injection site
Danish: Vælg indsprøjtningssted
English: Ankylosing Spondylitis Disease Activity Score C-Reactive Protein (AT-Placebo, N = 90; AT-Simponi 50 mg, N = 88; OSI-Placebo, N = 71; OSI-Simponi 50 mg, N = 71) n reflects number of patients with baseline and week 16 MRI data SPARCC (Spondyloarthritis Research Consortium of Canada) ** p < 0.0001 for Simponi vs placebo comparisons * p < 0.05 for Simponi vs placebo comparisons
Danish: Ankylosing Spondylitis Disease Activity Score C-Reactive Protein (AT-Placebo, N = 90; AT-Simponi 50 mg, N = 88; OSI-Placebo, N = 71; OSI-Simponi 50 mg, N = 71) n afspejler antal patienter med MRI-data ved baseline og uge 16
English: Check the number of pre-filled syringes Check the pre-filled syringes to make sure
Danish: Tjek antallet af fyldte injektionssprøjter Tjek de fyldte injektionssprøjter for at sikre, at
English: Viewing Window
Danish: Inspektionsvindue
English: Check the liquid in the pre-filled pen
Danish: Tjek væsken i den fyldte pen
English: For additional assistance refer to the Package Leaflet for your local representative contact information.
Danish: Hvis du har brug for yderligere hjælp, kan du finde kontaktoplysninger for din lokale repræsentant i indlægssedlen.
English: You will need these supplies:
Danish: Du skal bruge følgende:
English: For patients weighing less than 40 kg, a 45 mg/0.45 mL pre-filled pen is available.
Danish: Til patienter, der vejer under 40 kg, fås en 45 mg/0,45 ml fyldt pen.
English: • Manually press the plunger to inject, like a syringe
Danish: • du manuelt trykker på stemplet for at indsprøjte medicinen, ligesom på en injektionssprøjte
English: CARTON FOR 1 PRE-FILLED PEN AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Danish: KARTON FOR 1 FYLDT PEN MELLEMLIGGENDE PAKKE / DEL AF MULTIPAKKE (UDEN BLUE BOX)
English: Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Danish: Simponi er alene eller i kombination med MTX indiceret til behandling af aktiv og progressiv psoriasisartrit hos voksne, hvor responset på tidligere DMARD-behandling har været utilstrækkeligt.
English: IMPORTANT: Do not lift the pre-filled pen from the skin during the injection.
Danish: VIGTIGT: Undlad at løfte den fyldte pen væk fra huden under indsprøjtningen.
English: Patients treated with Simponi should be given the Patient Reminder Card which is included in the pack.
Danish: Patienter, som behandles med Simponi, skal have udleveret det patientinformationskort, som er vedlagt i pakningen.
English: Tell your doctor straight away if you develop symptoms of an allergic reaction after your treatment with Simponi.
Danish: Fortæl det omgående til din læge, hvis du oplever symptomer på en allergisk reaktion efter du er startet i behandling med Simponi.
English: • 1 Cotton ball or gauze pad
Danish: • 1 vatrondel eller gaze
English: Simponi induction only.
Danish: Kun Simponi-induktion.
English: Among those, 85, 66 and 53 patients had ACR 20/50/70 response, respectively, at week 104.
Danish: Ud af disse havde henholdsvis 85, 66 og 53 patienter et ACR 20-/50-/70-respons i uge 104.
English: After removing the pre-filled pen or the pre-filled syringe from the refrigerator it should be allowed to reach room temperature by waiting for 30 minutes, before injecting Simponi.
Danish: Efter den fyldte pen eller den fyldte injektionssprøjte er taget ud af køleskabet, skal den nå stuetemperatur i løbet af 30 minutter, før Simponi injiceres.
English: What Simponi contains The active substance is golimumab.
Danish: Simponi indeholder det aktive stof golimumab.
English: In the Phase III pJIA study through week 48, antibodies to golimumab were detected by the drug-tolerant EIA method in 40% (69/172) of golimumab treated children of which a majority had a titre lower than 1:1000.
Danish: I fase III-studiet med pJIA blev der til og med uge 48 ved hjælp af den lægemiddel-tolerante EIA-metode fundet antistoffer mod golimumab hos 40% (69/172) af de golimumab-behandlede børn, hvoraf størstedelen havde en titer under 1:1.000.
English: • Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes)
Danish: • Lichenoide reaktioner (kløende, rødligt-lilla hududslæt og/eller trådlignende gråhvide linjer på slimhinderne)
English: Pain as assessed by the Total Back Pain and Nocturnal Back Pain VAS, and disease activity as measured by ASDAS-C also showed statistically significant improvement from baseline to week 16 in patients treated with Simponi 50 mg compared to placebo (p < 0.0001).
Danish: Smerte vurderet ved VAS for total rygsmerte og natlig rygsmerte og sygdomsaktivitet målt ved ASDAS-C viste også statistisk signifikant bedring fra baseline til uge 16 hos patienter, der blev behandlet med Simponi 50 mg sammenlignet med placebo (p < 0,0001).
English: However, you and your doctor may decide that you may inject Simponi to yourself or to your child.
Danish: Du og din læge kan dog beslutte, at du selv kan indsprøjte Simponi eller give det til dit barn.
English: Uncommon: Arrhythmia, ischemic coronary artery disorders Rare: Congestive heart failure (new onset or worsening)
Danish: Ikke almindelig: Arytmi, iskæmisk koronararteriesygdom Sjælden: Hjerteinsufficiens (debuterende eller forværret)
English: More Simponi-treated patients demonstrated sustained mucosal healing (patients with mucosal healing at both week 30 and week 54) in the 50 mg group (42%, nominal p < 0.05) and 100 mg group (42%, p < 0.005) compared with patients in the placebo group (27%).
Danish: Flere Simponi-behandlede patienter udviste vedvarende heling af slimhinden (patienter med heling af slimhinde i både uge 30 og uge 54) i 50 mg-gruppen (42%, nominel p-værdi < 0,05) og i 100 mg-gruppen (42%, p < 0,005) sammenlignet med patienterne i placebogruppen (27%).
English: Treatment with concomitant MTX resulted in a lower proportion of patients with antibodies to golimumab than patients receiving golimumab without MTX (approximately 3% [41/1235] versus 8% [64/827], respectively).
Danish: Samtidig behandling med MTX resulterede i en mindre andel af patienter med antistoffer mod golimumab i forhold til patienter, der fik golimumab uden MTX (ca. hhv. 3% [41/1.235] versus 8% [64/827]).
English: Simponi is supplied in a single use pre-filled pen called SmartJect or as a single use pre-filled syringe.
Danish: Simponi leveres som en fyldt pen til engangsbrug kaldet SmartJect eller som en fyldt injektionssprøjte til engangsbrug.
English: Pack size of 1 pre-filled pen.
Danish: Pakningsstørrelse indeholdende 1 fyldt pen.
English: In GO-FORWARD, the (co-)primary endpoints were the percentage of patients achieving an ACR 20 response at week 14 and the improvement from baseline in Health Assessment Questionnaire (HAQ) at week 24.
Danish: I GO-FORWARD var de (sammensatte) primære endepunkter den procentdel af patienterne, der opnåede et ACR 20-respons i uge 14, og forbedringer fra baseline i Health Assessment Questionaire (HAQ) ved uge 24.
English: • Do not use the pre-filled pen if the expiration date has passed.
Danish: • Anvend ikke den fyldte pen, hvis udløbsdatoen er passeret.
English: Carriers of HBV who require treatment with golimumab should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Danish: Bærere af HBV, hvor behandling med golimumab er nødvendig, skal følges nøje under behandlingen og i adskillige måneder efter afslutning af behandlingen for at registrere sygdomstegn og symptomer på aktiv HBV-infektion.
English: Simponi Patient Reminder Card
Danish: Simponi patientinformationskort
English: Ankylosing spondylitis
Danish: Ankyloserende spondylit
English: If you are being treated with Simponi, you must avoid becoming pregnant by using adequate contraception during your treatment and for at least 6 months after the last Simponi injection.
Danish: Du skal undgå at blive gravid ved at anvende sikker prævention, mens du er i behandling med Simponi og mindst 6 måneder efter den sidste Simponi-injektion.
English: • Do not use the pre-filled pen if the seal is broken.
Danish: • Anvend ikke den fyldte pen, hvis forseglingen er brudt.
English: The medicine should be injected within 5 minutes after the needle cover has been removed.
Danish: Medicinen skal indsprøjtes inden for 5 minutter efter, at hætten er fjernet.
English: Among those, 40, 33 and 24 patients had ACR 20/50/70 response, respectively at week 104.
Danish: Blandt disse havde 40, 33 og 24 patienter henholdsvis ACR 20-/50-/70-respons ved uge 104.
English: The 154 children who achieved an ACR Ped 30 response at week 16 entered Part 2 of the study, the randomised withdrawal phase, and received Simponi 30 mg/m2 (maximum 50 mg) + MTX or placebo + MTX every 4 weeks.
Danish: De 154 børn, der opnåede et pædiatrisk ACR 30respons ved uge 16, fortsatte i studiets del 2, den randomiserede seponeringsfase, og fik Simponi 30 mg/m2 (højst 50 mg) + MTX eller placebo + MTX hver 4. uge.
English: Uncommon: Sepsis including septic shock, pyelonephritis Rare: Tuberculosis, opportunistic infections (such as invasive fungal infections [histoplasmosis, coccidioidomycosis, pneumocytosis], bacterial, atypical mycobacterial infection and protozoal), hepatitis B reactivation, bacterial arthritis, infective bursitis
Danish: Ikke almindelig: Sepsis inklusive septisk shock, pyelonefrit Sjælden: Tuberkulose, opportunistiske infektioner (såsom invasive svampeinfektioner [histoplasmose, kokcidioidomykose, pneumocystose], bakterielle, atypiske mykobakterie- og protozo-infektioner), hepatitis B-reaktivering, bakteriel artrit, infektiøs bursit
English: The most serious ARs that have been reported for golimumab include serious infections (including sepsis, pneumonia, TB, invasive fungal and opportunistic infections), demyelinating disorders, HBV reactivation, CHF, autoimmune processes (lupus-like syndrome), haematologic reactions, serious systemic hypersensitivity (including anaphylactic reaction), vasculitis, lymphoma and leukaemia (see section 4.4).
Danish: De alvorligste bivirkninger, som er rapporteret for golimumab, indbefatter alvorlige infektioner (inklusive sepsis, pneumoni, TB, invasive svampeinfektioner og opportunistiske infektioner), demyeliniseringssygdomme, HBV-reaktivering, kongestivt hjertesvigt, autoimmune processer (lupus-lignende syndrom), hæmatologiske reaktioner, alvorlig systemisk overfølsomhed (herunder anafylaktisk reaktion), vaskulitis, lymfom og leukæmi (se pkt.
English: Simponi is supplied in a single use pre-filled pen called VarioJect.
Danish: Simponi leveres som en fyldt pen til engangsbrug kaldet VarioJect.
English: No animal fertility studies have been conducted with golimumab.
Danish: Der er ikke udført fertilitetsstudier med golimumab på dyr.
English: Cap*
Danish: Hætte*
English: Responses observed in the Simponi treated groups were similar in patients receiving and not receiving concomitant MTX.
Danish: Responsene var sammenlignelige hos Simponibehandlede patienter, uanset om der blev givet MTX samtidigt eller ej.
English: • You may cover the injection site with a small adhesive bandage, if necessary.
Danish: • Hvis det er nødvendigt, kan du dække indsprøjtningsstedet med et lille stykke plaster.
English: Symptoms of leukaemia can include fever, feeling tired, frequent infections, easy bruising, and night sweats.
Danish: Symptomer på leukæmi kan være feber, træthed, hyppige infektioner, let ved at få blå mærker og nattesved.
English: The efficacy of Simponi was demonstrated in three multi-centre, randomised, double-blind, placebo-controlled studies in over 1500 patients ≥ 18 years of age with moderately to severely active RA diagnosed according to American College of Rheumatology (ACR) criteria for at least 3 months prior to screening.
Danish: Simponis virkning blev demonstreret i tre randomiserede, dobbeltblindede, placebokontrollerede multicenter-studier med over 1.500 patienter ≥ 18 år med moderat til svær aktiv RA, diagnosticeret i henhold til American College of Rheumatology (ACR)-kriterier i mindst 3 måneder op til screening.
English: In GO-BEFORE the change from baseline in the vdH-S score, a composite score of structural damage that radiographically measures the number and size of joint erosions and the degree of joint space narrowing in hands/wrists and feet, was used to assess the degree of structural damage.
Danish: vdH-S er en sammensat score for strukturel ødelæggelse, hvor antallet og omfanget af led-erosioner samt graden af ledforsnævring i hænder/håndled og fødder måles radiografisk.
English: After removing the pre-filled pen from the refrigerator it should be allowed to reach room temperature by waiting for 30 minutes, before injecting Simponi.
Danish: Efter den fyldte pen er taget ud af køleskabet, skal den nå stuetemperatur i løbet af 30 minutter, før Simponi injiceres.
English: If you do not respond well enough to these medicines, you will be given Simponi to treat your disease.
Danish: Hvis du ikke reagerer godt nok på disse lægemidler, kan du få Simponi til behandling af din sygdom.
English: When 50 mg golimumab was administered subcutaneously to patients with RA, PsA or AS every 4 weeks, serum concentrations reached steady state by week 12.
Danish: Efter subkutan administration af 50 mg golimumab hver 4. uge til patienter med RA, PsA eller AS, nåede serumkoncentrationen steady-state ved uge 12.
English: In controlled Phase IIb and/or III trials in RA, PsA, AS, nr-Axial SpA, severe persistent asthma, and Phase II/III trials in UC, no patients treated with golimumab developed anaphylactic reactions.
Danish: I de kontrollerede fase IIb- og/eller III-studier med RA, PsA, AS, nr-aksial SpA svær persisterende astma og fase II/III-studierne med UC udviklede ingen patienter i behandling med golimumab anafylaktiske reaktioner.
English: The other ingredients are sorbitol (E420), histidine, histidine hydrochloride monohydrate, polysorbate 80 and water for injections.
Danish: Øvrige indholdsstoffer: Sorbitol (E420), histidin, histidin-hydrochloridmonohydrat, polysorbat 80 og vand til injektionsvæsker.
English: The safety and efficacy of Simponi in patients aged less than 18 for indications other than pJIA have not been established.
Danish: Pædiatrisk population Simponis sikkerhed og virkning hos børn under 18 år er ikke klarlagt for andre indikationer end pJIA.
English: If you do not respond well enough to these medicines, you may be given Simponi to:
Danish: Hvis du ikke reagerer godt nok på disse lægemidler, vil du få Simponi for at: