FrancophonIA/ELRC3.0 huggingface dataset:
English: In the controlled period of pivotal trials, upper respiratory tract infection was the most common adverse reaction reported in 12.6% of golimumab-treated patients (incidence per 100 subject-years: 60.8; 95% CI: 55.0, 67.1) compared with 11.0% of control patients (incidence per 100 subject-years: 54.5; 95% CI: 46.1, 64.0).
Danish: I den kontrollerede periode af de pivotale studier var øvre luftvejsinfektion den hyppigste bivirkning og blev rapporteret hos 12,6% af de golimumab-behandlede patienter (hyppighed per 100 forsøgspersonår: 60,8; 95% CI: 55,0; 67,1) sammenlignet med hos 11,0% af kontrolpatienterne (hyppighed per 100 forsøgspersonår: 54,5; 95% CI: 46,1; 64,0).
English: If you have used or been given too much Simponi (either by injecting too much on a single occasion, or by using it too often), talk to your doctor or pharmacist straight away.
Danish: Kontakt straks din læge eller apotekspersonalet, hvis du har taget eller fået for meget Simponi (enten ved at indsprøjte for meget en enkelt gang eller ved at indsprøjte for ofte).
English: Injection site selection for caregivers (see figure 4)
Danish: Valg af indsprøjtningssted for hjælpere/plejere (se figur 4)
English: Golimumab should be used with caution in subjects with impaired hepatic function (see section 4.2).
Danish: Golimumab skal anvendes med forsigtighed hos personer med nedsat leverfunktion (se pkt.
English: Improvements in key measures of disease activity were observed at the first assessment (week 4) after the initial Simponi administration and were maintained through week 24.
Danish: Forbedringer i de vigtigste parametre for sygdomsaktivitet blev observeret ved den første evaluering (uge 4) efter Simponi-administration og ved uge 24.
English: Erosion Score Baseline
Danish: Erosions-score Baseline
English: *CHOKING HAZARD!
Danish: *KVÆLNINGSFARE!
English: A part of the pre-filled syringe, the needle cover, contains latex.
Danish: En del af den fyldte injektionssprøjte, beskyttelseshætten til nålen, indeholder latex.
English: • Scaly, peeling skin
Danish: • Udslæt og hudkløe
English: Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.
Danish: Det er blevet vist, at Simponi nedsætter progressionshastigheden af ødelæggelsen af de perifere led, målt ved røntgen, hos patienter med polyartikulære symmetriske undertyper af sygdommen (se pkt.
English: In controlled and uncontrolled portions of the studies with a median follow-up of approximately 4 years, the incidence per 100 subject-years of upper respiratory tract infections was 34.9 events; 95% CI: 33.8, 36.0 for golimumab treated patients.
Danish: I de kontrollerede og ikke-kontrollerede dele af studierne med en median follow-up på ca. 4 år var hyppigheden af øvre luftvejsinfektion per 100 forsøgspersonår 34,9 (95% CI: 33,8; 36,0) for golimumab-behandlede patienter.
English: Uncommon: Thyroid disorder (such as hypothyroidism, hyperthyroidism and goitre)
Danish: Det endokrine system Ikke almindelig: Thyroideasygdomme (såsom hypotyroidisme, hypertyroidisme og struma)
English: In GO-FORWARD clinically meaningful and statistically significant improvements were demonstrated in health-related quality of life as measured by the physical component score of the SF-36 in patients treated with Simponi versus placebo at week 24.
Danish: I GO-FORWARD demonstrerede Simponi klinisk relevant og statistisk signifikant forbedring i sundhedsrelateret livskvalitet målt som den fysiske komponent af SF-36 i forhold til placebo ved uge 24.
English: During the Simponi Phase IIb and Phase III clinical trials in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), the incidence of lymphoma in golimumab-treated patients was higher than expected in the general population.
Danish: Under fase IIb og fase III i kliniske studier med Simponi af reumatoid artrit (RA), psoriasisartrit (PsA) og ankyloserende spondylit (AS) var forekomsten af lymfomer hos golimumab-behandlede patienter højere end forventet i den generelle population.
English: Janssen Biologics B.V. Einsteinweg 101
Danish: Janssen Biologics B.V.
English: Common: Pruritus, rash, alopecia, dermatitis Uncommon: Bullous skin reactions, psoriasis (new onset or worsening of pre-existing psoriasis, palmar/plantar and pustular), urticaria Rare: Lichenoid reactions, skin exfoliation, vasculitis (cutaneous) Musculoskeletal and connective tissue disorders
Danish: Almindelig: Pruritus, udslæt, alopeci, dermatit Ikke almindelig: Bulløse hudreaktioner, psoriasis (debuterende eller forværring af eksisterende psoriasis, palmoplantar og pustuløs), urticaria Sjælden: Lichenoide reaktioner, hudeksfoliation, vaskulitis (kutan) Knogler, led, muskler og bindevæv Sjælden: Lupuslignende syndrom
English: Keep out of reach of children.
Danish: Opbevares utilgængeligt for børn.
English: Patients receiving placebo + MTX were switched to Simponi 50 mg + MTX after week 24.
Danish: Patienter, som fik placebo + MTX, skiftede til Simponi 50 mg + MTX efter 24. uge.
English: Simponi may be stored at temperatures up to a maximum of 25°C for a single period of up to 30 days, but not exceeding the original expiry date printed on the carton.
Danish: Simponi kan opbevares ved temperaturer på op til højst 25 °C i en enkelt periode på op til 30 dage, men den oprindelige udløbsdato, der er trykt på kartonen, må ikke overskrides.
English: Keep holding the pre-filled pen upright.
Danish: Hold fortsat den fyldte pen opad.
English: During the Simponi Phase IIb and Phase III clinical trials in RA, PsA and AS, the incidence of lymphoma in golimumab-treated patients was higher than expected in the general population.
Danish: Under fase IIb og fase III i kliniske studier med Simponi af RA, PsA og AS var forekomsten af lymfomer hos golimumab-behandlede patienter højere end forventet i den generelle population.
English: In the controlled period of the pivotal trials in RA, PsA, AS, nr-Axial SpA, and UC, upper respiratory tract infection was the most common adverse reaction (AR) reported in 12.6% of golimumab-treated patients compared with 11.0% of control patients.
Danish: I den kontrollerede periode af pivotale studier af RA, PsA, AS, nr-aksial SpA og UC var øvre luftvejsinfektion den hyppigste bivirkning og blev rapporteret hos 12,6% af de patienter, som blev behandlet med golimumab, sammenlignet med hos 11,0% af kontrolpatienterne.
English: Simponi 45 mg/0.45 mL solution for injection in pre-filled pen For paediatric patients below 40 kg golimumab
Danish: Simponi 45 mg/0,45 ml injektionsvæske, opløsning i fyldt pen Til pædiatriske patienter under 40 kg golimumab
English: Do not touch the plunger during needle cover removal.
Danish: Rør ikke ved stemplet, når du fjerner nålebeskyttelseshætten.
English: • Increase in blood cholesterol levels
Danish: • Øget kolesteroltal
English: Wait 30 minutes to allow pre-filled pen to reach room temperature
Danish: Vent 30 minutter, så den fyldte pen opnår stuetemperatur
English: • Axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis
Danish: • Aksial spondylartrit herunder ankyloserende spondylit og non-radiografisk aksial spondylartrit
English: PRE-FILLED PEN CARTON
Danish: FYLDT PEN KARTON
English: For more information on sorbitol (E420), see Section 2.
Danish: Se punkt 2 for mere information om sorbitol (E420).
English: • Low red blood cell counts
Danish: • Lavt antal røde blodceller
English: • 1 Adhesive bandage
Danish: • 1 plaster
English: Choosing and preparing the injection site (see figure 3)
Danish: Valg og forberedelse af indsprøjtningssted (se figur 3)
English: • Please read the enclosed package leaflet
Danish: • Læs den vedlagte indlægsseddel
English: Remove the pre-filled pen from the carton
Danish: Tag den fyldte pen ud af kartonen
English: Statistically significant improvements in signs and symptoms of severe active nr-Axial SpA were demonstrated in patients treated with Simponi 50 mg compared to placebo at week 16 (Table 6).
Danish: Der blev påvist statistisk signifikant bedring i tegn og symptomer på svær, aktiv nr-aksial SpA ved uge 16 hos patienter, der var blevet behandlet med Simponi 50 mg sammenlignet med placebo (tabel 6).
English: Patients receiving placebo were switched to Simponi 50 mg after week 24.
Danish: Patienter, som fik placebo, blev skiftet over til Simponi 50 mg efter uge 24.
English: The needle cover contains latex rubber.
Danish: Beskyttelseshætten på nålen indeholder latexgummi.
English: Subject/parent global assessment of overall well-being (VAS 0-10 cm) Number of active joints Number of joints with limited range of motion Physical function by CHAQ ESR (mm/h)
Danish: Patienters/forældres globale vurdering af generelt velbefindende (VAS 0-10 cm) Antal aktive led
English: A fertility study in mice, using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, showed no relevant effects on fertility (see section 5.3).
Danish: Der blev ikke vist relevante effekter på fertiliteten i et fertilitetsstudie på mus ved brug af et analogt antistof, som selektivt hæmmer den funktionelle aktivitet af TNFα hos mus (se pkt.
English: Ankylosing spondylitis and non-radiographic axial spondyloarthritis Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory diseases of the spine.
Danish: Ankyloserende spondylit og non-radiografisk aksial spondylartrit Ankyloserende spondylit og non-radiografisk aksial spondylartrit er betændelsessygdomme i rygraden.
English: Lift the pre-filled pen away from the skin.
Danish: Løft den fyldte pen væk fra huden.
English: • Set prescribed dose
Danish: • du indstiller den ordinerede dosis
English: Table 1 Tabulated list of ARs
Danish: Tabel 1 Tabel over bivirkninger
English: Symptoms of blood disease can include a fever that does not go away, bruising or bleeding very easily or looking very pale.
Danish: Symptomer på blodsygdom kan være vedvarende feber, blå mærker, eller at du bløder meget nemt eller ser meget bleg ud.
English: Change from baseline JSN Score Baseline
Danish: Ændring fra baseline JSN-score Baseline
English: Simponi in combination with methotrexate (MTX) is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX.
Danish: Simponi er i kombination med methotrexat (MTX) indiceret til behandling af polyartikulær juvenil idiopatisk artrit hos børn i alderen 2 år og derover, hvor responset på tidligere behandling med MTX har været utilstrækkeligt.
English: Result _______________
Danish: Resultat ______________
English: What you need to know before you use Simponi
Danish: Det skal du vide, før du begynder at tage Simponi
English: Simponi in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX.
Danish: Simponi er i kombination med MTX indiceret til behandling af polyartikulær juvenil idiopatisk artrit hos børn i alderen 2 år og derover, hvor responset på tidligere behandling med MTX har været utilstrækkeligt.
English: Can be stored at room temperature (up to 25°C) for a single period up to 30 days, but not exceeding the original expiry date.
Danish: Kan opbevares ved stuetemperatur (op til 25 °C) i en enkelt periode på op til 30 dage, men den oprindelige udløbsdato må ikke overskrides.
English: Preparing injection site
Danish: Forberedelse af indsprøjtningsstedet
English: Each pre-filled syringe contains 41 mg sorbitol per 100 mg dose.
Danish: Hver fyldt injektionssprøjte indeholder 41 mg sorbitol per 100 mg dosis.
English: Symptoms of heart failure include shortness of breath or swelling of your feet.
Danish: Symptomer på hjertesvigt inkluderer åndenød eller hævede fødder.
English: Choosing and preparing the injection site (see figure 2)
Danish: Valg og forberedelse af indsprøjtningssted (se figur 2)
English: Do not lift the pre-filled pen from the skin during the injection.
Danish: Undlad at løfte den fyldte pen væk fra huden under indsprøjtningen.
English: Change from baseline Erosion Score Baseline
Danish: Ændring fra baseline Erosions-score Baseline
English: • If you are more than 2 weeks late, inject the forgotten dose as soon as you remember and talk to your doctor or pharmacist to ask when you need to take the next dose.
Danish: • Indsprøjt den glemte dosis hurtigst muligt og tal med din læge eller apotekspersonalet om hvornår du skal tage den næste dosis, hvis du er mere end 2 uger forsinket.
English: One pre-filled pen contains 45 mg golimumab* in 0.45 mL.
Danish: En fyldt pen indeholder 45 mg golimumab* i 0,45 ml.
English: Discontinuation of golimumab should be considered if these disorders develop (see section 4.8).
Danish: Seponering af golimumab bør overvejes, hvis disse sygdomme opstår/forværres (se pkt.
English: Patients with body weight less than 80 kg
Danish: Patienter med legemsvægt ≥ 80 kg
English: In the controlled and uncontrolled periods of the pivotal trials with a median follow-up of up to 3 years, a greater incidence of demyelination was observed in patients receiving golimumab 100 mg compared with patients receiving golimumab 50 mg (see section 4.4).
Danish: I de kontrollerede og ikke-kontrollerede perioder af de pivotale studier med en median opfølgningstid på op til 3 år, sås en hyppigere forekomst af demyelinisering hos patienter, som fik golimumab 100 mg, sammenlignet med patienter, som fik golimumab 50 mg (se pkt.
English: Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
Danish: Behandling skal initieres og overvåges af kvalificerede læger med erfaring i diagnosticering og behandling af reumatoid artrit, psoriasisartrit, ankyloserende spondylit, non-radiografisk aksial spondylartrit eller colitis ulcerosa.
English: Rheumatoid arthritis is an inflammatory disease of the joints.
Danish: Reumatoid artrit (kronisk leddegigt) er en betændelsessygdom i leddene.
English: • Place your pen in a sharps container straight away.
Danish: • Læg straks pennen i en nålebeholder.
English: There was a trend toward higher apparent clearance of golimumab with increasing weight (see section 4.2).
Danish: Vægtens indvirkning på farmakokinetikken Der var en tendens til en højere tilsyneladende clearance af golimumab ved øget vægt (se pkt.
English: This medicine contains 18.45 mg sorbitol (E420) in each pre-filled pen.
Danish: Dette lægemiddel indeholder 18,45 mg sorbitol (E420) i hver fyldt pen.
English: Symptoms may include changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.
Danish: Symptomer inkluderer synsændringer, muskelsvaghed i arme eller ben eller følelsesløshed eller prikken et sted i kroppen.
English: ARs observed in clinical studies and reported from world-wide post-marketing use of golimumab are listed in Table 2.
Danish: Tabel 2 viser de bivirkninger, som er set i kliniske studier af golimumab samt rapporteret post-marketing efter anvendelse af golimumab verden over.
English: Do not lift the pre-filled pen away from your skin.
Danish: Løft ikke den fyldte pen væk fra huden.
English: In general, no clinically meaningful differences in measures of efficacy were observed between the Simponi 50 mg and 100 mg dosing regimens through week 24.
Danish: Generelt er der ingen klinisk relevant forskel i effektmålene mellem Simponi 50 mg og 100 mg doseringsregime til og med uge 24.
English: In general, no clinically meaningful differences in measures of efficacy were observed between the Simponi 50 mg and 100 mg dosing regimens through week 104.
Danish: Generelt blev der ikke observeret nogle klinisk relevante forskelle i effekten mellem Simponi 50 mg og 100 mg dosisregimerne til og med uge 104.
English: Figure 9
Danish: Figur 9
English: Do not use the pre-filled syringe if the expiration date has passed.
Danish: Anvend ikke den fyldte injektionssprøjte, hvis udløbsdatoen er passeret.
English: Following a single subcutaneous administration of golimumab to healthy subjects or patients with RA, the median time to reach maximum serum concentrations (Tmax) ranged from 2 to 6 days.
Danish: Mediantiden til at nå maksimal serumkoncentration (Tmax) efter en enkelt subkutan administration af golimumab til raske forsøgspersoner eller patienter med RA varierede fra 2 til 6 dage.
English: • Injection site reactions (including redness, hardness, pain, bruising, itching, tingling and irritation)
Danish: • Reaktioner på indsprøjtningsstedet (inklusive rødme, hårdhed, smerte, blå mærker, kløe,
English: Improvements were observed at the first assessment (week 4) after the initial Simponi administration.
Danish: Der sås bedring ved første vurdering (uge 4) efter den initiale administration af Simponi.
English: What Simponi contains
Danish: Simponi indeholder:
English: In the controlled period of RA and AS pivotal trials, ALT elevations ≥ 5 x ULN were uncommon and seen in more golimumab-treated patients (0.4% to 0.9%) than control patients (0.0%).
Danish: I de kontrollerede perioder af de pivotale RA- og AS-studier var forhøjet ALAT ≥ 5 x ULN ikke almindelig og blev observeret hos flere golimumab-behandlede patienter (0,4% til 0,9%) end hos kontrolpatienter (0,0%).
English: In the controlled and uncontrolled periods of the pivotal UC trials with a median follow-up of approximately 2 years, the proportion of patients with ALT elevations ≥ 5 x ULN was 0.8% in patients receiving golimumab during the maintenance portion of the UC study.
Danish: I de kontrollerede og ikke-kontrollerede perioder af de pivotale UC-studier med en median opfølgningsperiode på ca. 2 år var andelen af patienter med forhøjet ALAT ≥ 5 x ULN 0,8% hos de patienter, der fik golimumab under vedligeholdelsesdelen af UC-studiet.
English: In the controlled periods of pivotal trials and through approximately 4 years of follow-up, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between the golimumab and the control groups.
Danish: I de kontrollerede perioder af de pivotale studier og i en opfølgningstid på ca. 4 år var hyppigheden af non-lymfome maligne sygdomme (eksklusive non-melanom hudkræft) sammenlignelig i golimumabog kontrolgrupperne.
English: • This medicine can also be stored out of the refrigerator at temperatures up to a maximum of 25°C for a single period of up to 30 days, but not beyond the original expiry date printed on the carton.
Danish: • Lægemidlet kan også opbevares uden for køleskab ved temperaturer på op til højst 25 °C i en enkelt periode på op til 30 dage, men den oprindelige udløbsdato, der er trykt på kartonen, må ikke overskrides.
English: ARs observed in clinical studies and reported from world-wide post-marketing use of golimumab are listed in Table 1.
Danish: Tabel 1 viser de bivirkninger, som er set i kliniske studier af golimumab samt rapporteret post-marketing efter anvendelse af golimumab verden over.
English: Liquid will squirt out.
Danish: Der vil sprøjte væske ud.
English: Wait 30 minutes to allow pre-filled syringe to reach room temperature
Danish: Vent 30 minutter, så den fyldte injektionssprøjte opnår stuetemperatur
English: • The recommended dose is 50 mg given once a month, on the same date each month.
Danish: • Den anbefalede dosering er 50 mg en gang om måneden på den samme dato hver måned.
English: 135 to < 145
Danish: 135 til < 145
English: Remove the needle cover (see figure 5)
Danish: Fjern hætten (figur 5)
English: In controlled and uncontrolled periods of the UC pivotal trials with a median follow-up of approximately 2 years, the proportion of patients with mild ALT elevations was 24.7% in patients receiving golimumab during the maintenance portion of the UC study.
Danish: I de kontrollerede og ikke-kontrollerede perioder af de pivotale UC-studier med en median opfølgningsperiode på ca. 2 år var andelen af patienter med let forhøjet ALAT 24,7% hos patienter, der fik golimumab under vedligeholdelsesdelen af UC-studiet.
English: Write the new expiry date on the back panel of the carton including day/month/year (no more than 30 days after the medicine is removed from the refrigerator).
Danish: Skriv den nye udløbsdato på bagsiden af kartonen med dag/måned/år (højst 30 dage efter lægemidlet er taget ud af køleskabet).
English: The solution can be used if it contains a few small translucent or white particles of protein.
Danish: Injektionsvæsken kan benyttes, selv om den indeholder nogle få små, halvgennemsigtige eller hvide partikler af protein.
English: Because latex may cause severe allergic reactions, talk to your doctor before using Simponi if you or your carer are allergic to latex.
Danish: Tal med din læge, inden du anvender Simponi, hvis du eller din hjælper/plejer er allergisk over for latex, da latex kan forårsage alvorlige allergiske reaktioner.
English: Figure 10
Danish: Figur 10
English: 165 to < 175
Danish: 165 til < 175
English: You may or may not feel a needle prick at this time.
Danish: Du vil muligvis mærke et nålestik.
English: Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
Danish: Behandling skal initieres og overvåges af kvalificerede læger med erfaring i diagnosticering og behandling af reumatoid artrit, polyartikulær juvenil idiopatisk artrit, psoriasisartrit, ankyloserende spondylit, non-radiografisk aksial spondylartrit eller colitis ulcerosa.
English: The pre-filled pen is to be used only one time.
Danish: Den fyldte pen er kun til engangsbrug.
English: Patients were randomised to receive placebo + MTX, Simponi 50 mg + MTX, Simponi 100 mg + MTX or Simponi 100 mg + placebo.
Danish: Patienter blev randomiseret til at modtage placebo + MTX, Simponi 50 mg + MTX, Simponi 100 mg + MTX eller Simponi 100 mg + placebo.
English: Symptoms include persistent rash, fever, joint pain and tiredness.
Danish: Symptomer inkluderer vedvarende udslæt, feber, ledsmerter og træthed.
English: Responses were observed at the first assessment (week 4) after the initial Simponi administration.
Danish: Respons blev observeret ved første evaluering (uge 4) efter den initiale Simponiadministration.
English: Write the new expiry date on the carton including day/month/year (no more than 30 days after the medicine is removed from the refrigerator).
Danish: Skriv den nye udløbsdato på kartonen med dag/måned/år (højst 30 dage efter lægemidlet er taget ud af køleskabet).
English: Each pre-filled syringe contains 20.5 mg sorbitol per 50 mg dose.
Danish: Hver fyldt injektionssprøjte indeholder 20,5 mg sorbitol per 50 mg dosis.
English: Among patients remaining in the study and treated with Simponi, improvement of the SF-36 physical component was similar from week 104 through week 256.
Danish: Blandt de patienter, der blev i studiet og fik behandling med Simponi, var forbedringen i den fysiske komponent SF-36 den samme fra uge 104 til og med uge 256.
English: Among patients who remained on the Simponi treatment to which they were randomised at study start, improvement of the SF-36 physical component was maintained through week 104.
Danish: Hos de patienter, som blev i samme behandling med Simponi, som de var randomiseret til fra studiestart, blev en forbedring i den fysiske komponent i SF-36 opretholdt til og med uge 104.