FrancophonIA/ELRC3.0 huggingface dataset:
English: In GO-AFTER, the percentage of patients achieving an ACR 20 response was greater for patients receiving Simponi than for patients receiving placebo regardless of the reason reported for discontinuation of one or more prior anti-TNF therapies.
Danish: I GO-AFTER var den procentdel af patienterne, der fik et ACR 20-respons, større for patienter, der fik Simponi, i forhold til patienter, der fik placebo, uanset begrundelsen for ophør af en eller flere tidligere anti-TNF-behandlinger.
English: Do not attempt to use any leftover medicine in the pre-filled pen.
Danish: Undlad at anvende eventuel resterende medicin i den fyldte pen.
English: • Asthma, shortness of breath, wheezing
Danish: • Astma, åndenød, hvæsende vejrtrækning
English: Do not touch this area again before giving the injection.
Danish: Rør ikke dette område igen før indsprøjtningen gives.
English: Figure 5a
Danish: Figur 5a
English: An effect on serum golimumab concentrations was seen at titres of > 1:100 while an effect on efficacy was not seen until titres of > 1:1000, though the numbers of children with titres of > 1:1000 were low (N = 8).
Danish: Der blev set en indvirkning på golimumabkoncentrationen i serum ved titre > 1:100, mens der ikke blev set en indvirkning på effekten før titre > 1:1000, selvom antallet af børn med titre > 1:1000 var lavt (N = 8).
English: • If you received Simponi during your pregnancy, your baby may have a higher risk for getting an infection.
Danish: • Du var i behandling med Simponi under din graviditet, da dit barn kan have en øget risiko for at få en infektion.
English: Patients who develop a new infection while undergoing treatment with golimumab should be monitored closely and undergo a complete diagnostic evaluation.
Danish: Patienter, som udvikler en ny infektion, mens de er i behandling med golimumab, bør monitoreres tæt og gennemgå en komplet diagnostisk evaluering.
English: Among patients who entered the study extension, the proportion of subjects who remained corticosteroid free was generally maintained through week 216.
Danish: Blandt de patienter, som indtrådte i studieforlængelsen, blev andelen af forsøgspersoner, som forblev kortikosteroidfrie, generelt opretholdt til og med uge 216.
English: Pregnancy and breast-feeding Talk to your doctor before using Simponi if:
Danish: Graviditet og amning Tal med din læge, før du tager Simponi, hvis:
English: children entered a long-term extension.
Danish: fortsatte børnene i en længerevarende udvidelsesfase.
English: If multiple injections are required, the injections should be administered at different sites on the body.
Danish: Hvis det er nødvendigt med flere injektioner, skal disse gives forskellige steder på kroppen.
English: * Human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology.
Danish: * Humant IgG1ĸ monoklonalt antistof fremstillet ved rekombinant DNA-teknologi i en murin hybridom cellelinje.
English: Ankylosing spondylitis (AS)
Danish: Ankyloserende spondylit (AS)
English: GO-FORWARD evaluated 444 patients who had active RA despite a stable dose of at least 15 mg/week of MTX and who had not been previously treated with an anti-TNF agent.
Danish: GO-FORWARD evaluerede 444 patienter, som havde aktiv RA trods en stabil MTX dosis på mindst 15 mg/uge, og som ikke var tidligere behandlet med et anti-TNF-middel.
English: • On rare occasions, people treated with TNF blockers have developed lupus.
Danish: • I sjældne tilfælde har patienter behandlet med TNF-blokkere udviklet lupus.
English: • blood disease (common).
Danish: • Blodsygdom (almindelig).
English: Do not put the cap back on, this may damage the hidden needle.
Danish: Undlad at sætte hætten på igen, da den kan beskadige den skjulte nål.
English: 1.2 During and after Simponi treatment:
Danish: 1.2 Under og efter behandling med Simponi
English: Tell your doctor straight away if you have ever been diagnosed with or develop symptoms of a demyelinating disease such as multiple sclerosis.
Danish: Fortæl det straks til din læge, hvis du nogensinde har haft eller udvikler symptomer på en demyeliniserende sygdom såsom multipel sklerose.
English: In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, anti-tuberculosis therapy should be considered before the initiation of golimumab.
Danish: Til patienter, der har adskillige eller signifikante risikofaktorer for tuberkulose og har en negativ test for latent tuberkulose, bør anti-tuberkulosebehandling overvejes før initieringen af golimumab.
English: Patients were assessed for UC disease activity by partial Mayo score every 4 weeks (loss of response was confirmed by endoscopy).
Danish: Patienterne blev vurderet for UC sygdomsaktivitet ved partiel Mayo-score hver 4. uge (manglende respons blev bekræftet ved endoskopi).
English: Throw the used pre-filled pen away
Danish: Smid den brugte fyldte pen væk
English: • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX.
Danish: • Behandling af svær, aktiv og progressiv reumatoid artrit hos voksne patienter, som ikke tidligere har været behandlet med MTX.
English: • When the plunger is pushed as far as it will go, continue to keep the pressure on the plunger head, take out the needle and let go of the skin (see figure 8).
Danish: • Når stemplet er presset så langt ned som muligt, så fortsæt med at holde tryk på stemplet, tag nålen ud og giv slip på huden (se figur 8).
English: • Push the open end of the pre-filled pen firmly against the skin at a 90-degree angle until the Safety Sleeve slides fully into the Clear Cover (Figure 6).
Danish: • Pres den åbne ende af den fyldte pen fast mod huden i en ret vinkel (90 grader), indtil sikkerhedskraven glider helt ind i clear cover (figur 6).
English: Week 14 33% 55%*
Danish: Uge 14 33% 55%*
English: In these studies, Simponi demonstrated clinically meaningful and statistically significant improvement in HAQ DI from baseline versus control at week 24.
Danish: Simponi viste i disse studier klinisk relevant og statistisk signifikant forbedring i HAQ DI fra baseline versus kontrol ved uge 24.
English: • Slow down the damage to your bones and joints.
Danish: • Nedsætte hastigheden af beskadigelse af dine knogler og led.
English: Symptoms can include joint pain or a rash on cheeks or arms that is sensitive to the sun. sarcoidosis (rare).
Danish: Symptomer kan være ledsmerter eller et udslæt på kinder eller arme, som er følsomt over for sol. sarkoidose (sjælden).
English: 2333 CB Leiden The Netherlands
Danish: 2333 CB Leiden Holland
English: In addition to the primary endpoint(s), additional assessments of the impact of Simponi treatment on the signs and symptoms of arthritis, radiographic response, physical function and health-related quality of life were performed.
Danish: Ud over de primære endepunkter blev betydningen af Simponi-behandling på tegn og symptomer på artrit, radiografisk respons, fysisk funktion og sundhedsrelateret livskvalitet evalueret.
English: • Do not touch this area again before giving the injection.
Danish: • Rør ikke dette område igen før indsprøjtningen gives.
English: Because of the nature of the adverse events seen with this combination therapy, similar toxicities may also result from the combination of anakinra and other TNF-blocking agents.
Danish: På grund af bivirkningerne set ved denne kombinationsbehandling kan lignende toksiciteter muligvis forekomme ved kombination af anakinra med andre TNF-blokerende midler.
English: • If multiple injections are required for a single administration, the injections should be administered at different sites on the body.
Danish: • Hvis det er nødvendigt med flere indsprøjtninger til en enkelt medicinindgivelse, skal indsprøjtningerne gives forskellige steder på kroppen.
English: Approximately 93% of patients who were receiving Simponi at the beginning of the open-label extension (week 16) remained on treatment through the end of the study (week 52).
Danish: Ca. 93% af patienterne, som fik Simponi i starten af den åbne studieforlængelse (uge 16), forblev i behandling til og med afslutningen af studiet (uge 52).
English: Patients with each sub-type of psoriatic arthritis were enrolled, including polyarticular arthritis with no rheumatoid nodules (43%), asymmetric peripheral arthritis (30%), distal interphalangeal (DIP) joint arthritis (15%), spondylitis with peripheral arthritis (11%), and arthritis mutilans (1%).
Danish: Patienter med hver subtype af psoriasisartrit blev inkluderet, inklusive polyartikulær artrit uden reumatoide noduli (43%), asymmetrisk perifer artrit (30%), distal interphalangeal (DIP) ledartrit (15%), spondylit med perifer artrit (11%) og artrit mutilans (1%).
English: In GO-FORWARD and GO-AFTER, statistically significant improvements were observed in fatigue as measured by functional assessment of chronic illness therapy-fatigue scale (FACIT-F).
Danish: I GO-FORWARD og GO-AFTER blev der observeret statistisk signifikante forbedringer i træthed målt som funktionel vurdering af kronisk sygdomsbehandling (FACIT-F).
English: Vaccinations/therapeutic infectious agents
Danish: Vaccinationer/terapeutiske smitstoffer
English: Children in this study demonstrated ACR Ped 30, 50, 70, and 90 responses from week 4.
Danish: Børnene i dette studie udviste pædiatrisk ACR 30-, 50-, 70- og 90-respons fra uge 4.
English: Efficacy evaluation in the study extension was based on changes in corticosteroid use, Physician's Global Assessment (PGA) of disease activity, and improvement in quality of life as measured by Inflammatory Bowel Disease Questionnaire (IBDQ).
Danish: Vurderingen af virkning i studieforlængelsen blev baseret på ændringer i brug af kortikosteroider, lægens globale vurdering af sygdomsaktivitet og forbedring af livskvalitet målt ved spørgeskemaet Inflammatory Bowel Disease Questionnaire (IBDQ).
English: The safety of golimumab has been studied in a phase III study of 173 pJIA patients from 2 to 17 years of age.
Danish: Golimumabs sikkerhed er undersøgt i et fase-III studie med 173 pJIA-patienter i alderen 2 til 17 år.
English: Cancer and lymphoma Tell your doctor if you have ever been diagnosed with lymphoma (a type of blood cancer) or any other cancer before you use Simponi.
Danish: Kræft og lymfom Fortæl det til din læge, før du får Simponi, hvis du har eller nogensinde har haft lymfom (en type blodkræft) eller enhver anden form for kræft.
English: A generally greater effect of Simponi 50 mg + MTX versus MTX alone was demonstrated in the indicated population compared with the overall population.
Danish: Der blev generelt vist en større effekt af Simponi 50 mg + MTX versus MTX alene i den nævnte population sammenlignet med den samlede population.
English: 70 to < 75 0.15 0.15 0.2 75 to < 85 0.15 0.15 0.2 85 to < 95 0.15 0.2
Danish: 70 til < 75 0,15 0,15 0,2 75 til < 85 0,15 0,15 0,2 85 til < 95 0,15 0,2
English: In vitro, TNF-induced secretion of interleukin (IL)-6, IL-8 and granulocyte-macrophage colony stimulating factor (GM-CSF) by human endothelial cells was also inhibited by golimumab.
Danish: In vitro var TNF-induceret sekretion af interleukin (IL)-6, IL-8 og granulocyt/makrofag-kolonistimulerende faktor (GM-CSF) fra humane endotelceller også hæmmet af golimumab.
English: The orange priming band will disappear.
Danish: Den orange stribe til klargøring forsvinder.
English: • Inflammation of blood vessels in internal organs
Danish: • Betændelse i blodkarrene i de indre organer
English: Inspect carton
Danish: Undersøg kartonen
English: If an anaphylactic reaction or other serious allergic reactions occur, administration of golimumab should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis en anafylaktisk reaktion eller en anden alvorlig allergisk reaktion forekommer, skal behandlingen med golimumab stoppes øjeblikkeligt og passende behandling igangsættes.
English: Due to the higher sensitivity and the improved drug tolerance, a higher incidence of antibodies to golimumab was expected to be detected with the drug-tolerant EIA method compared to the EIA method.
Danish: På grund af højere følsomhed og bedre lægemiddel-tolerance var det forventet, at der ville blive fundet en højere incidens af antistoffer mod golimumab med den lægemiddel-tolerante EIA-metode i forhold til EIA-metoden.
English: Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNF-α) inhibitors, ATC code: L04AB06
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, tumornekrosefaktor-alfa (TNF)-hæmmere, ATC-kode: L04AB06
English: In a developmental toxicity study conducted in mice following administration of the same analogous antibody, and in cynomolgus monkeys using golimumab, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
Danish: I et udviklingstoksicitetsstudie i mus, hvor de fik administreret det samme antistof, og i cynomolgusaber, der fik golimumab, var der ingen indikation for modertoksicitet, embryotoksicitet eller teratogenitet.
English: Physical function and health-related quality of life Physical function and disability were assessed as a separate endpoint in GO-FORWARD and GO-AFTER using the disability index of the HAQ DI.
Danish: Fysisk funktion og funktionsnedsættelse blev bedømt som et separat endepunkt i GO-FORWARD og GO-AFTER ved brug af funktionsindexet HAQ DI.
English: • Pain and ulcers in the mouth
Danish: • Smerter og sår i munden
English: Your doctor will also give you a Patient Reminder Card, which contains important safety information you need to be aware of before and during your treatment with Simponi.
Danish: Din læge har også givet dig et patientinformationskort, der indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under behandling med Simponi.
English: It is important that the right strength is used to administer the correct dose as indicated in the posology (see section 4.2).
Danish: Det er vigtigt, at den rigtige styrke anvendes til administration af den korrekte dosis, som angivet under dosering (se pkt.
English: Eighty-two percent (18/22) of antibody-positive patients had neutralising antibodies in vitro.
Danish: 82% (18/22) af de antistofpositive patienter havde neutraliserende antistoffer in vitro.
English: Key results are shown in Table 6 and described below.
Danish: Nøgleresultaterne fremgår af tabel 6 og er beskrevet nedenfor.
English: 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: 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: Make sure you dispose of the bin as instructed by your doctor or nurse.
Danish: Sørg for at bortskaffe beholderen som instrueret af din læge eller sygeplejerske.
English: Patients were allowed to continue concomitant DMARD therapy with MTX, sulfasalazine (SSZ), and/or hydroxychloroquine (HCQ) during the study.
Danish: Patienterne fik lov til at fortsætte med DMARD-behandling med MTX, sulfasalazin (SSZ) og/eller hydroxychloroquin (HCQ) under studiet.
English: • Tell your doctor or pharmacist if you are taking any other medicines that affect your immune system.
Danish: • Fortæl din læge eller apotekspersonalet, hvis du tager anden medicin, der påvirker dit immunsystem.
English: Each pack is provided with instructions for use that fully describe the use of the pen.
Danish: Hver pakning leveres med en brugsvejledning, der fuldt beskriver brugen af pennen.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier vedrørende eventuelle uforligeligheder, må dette præparat ikke blandes med andre præparater.
English: GO-BEFORE evaluated 637 patients with active RA who were MTX-naïve and had not previously been treated with an anti-TNF agent.
Danish: GO-BEFORE evaluerede 637 patienter med aktiv RA, som var MTX-naive og ikke tidligere havde været behandlet med anti-TNF-stoffer.
English: The higher incidence of antibodies with the drug-tolerant EIA method, because they were mainly low titre antibodies, did not have an apparent impact on drug levels, efficacy and safety and therefore does not represent any new safety signal.
Danish: Den højere incidens af antistoffer ved den lægemiddel-tolerante EIAmetode havde ikke en klar indvirkning på lægemiddelniveau, virkning og sikkerhed og repræsenterer derfor ikke nye sikkerhedssignaler, da det hovedsageligt var antistoffer med lav titer.
English: If this happens, do not ride bicycles, drive or use any tools or machines.
Danish: Hvis dette sker, må du ikke køre på cykel, køre bil eller betjene nogen form for værktøj eller maskiner.
English: Dizziness may however occur after you take Simponi.
Danish: Der kan dog opstå svimmelhed, efter du har taget Simponi.
English: • Do not warm the pre-filled pen in any other way (for example, do not warm it in a microwave or in hot water).
Danish: • Varm ikke den fyldte pen på andre måder (fx må den ikke varmes i en mikrobølgeovn eller i varmt vand).
English: • Allow the skin to dry before injecting.
Danish: • Lad huden tørre inden indsprøjtning.
English: The efficacy of Simponi through week 6 was assessed in this study.
Danish: Simponis virkning til og med uge 6 blev vurderet i dette studie.
English: Polyarticular juvenile idiopathic arthritis is an inflammatory disease that causes joint pain and swelling in children.
Danish: Polyartikulær juvenil idiopatisk artrit er en betændelsessygdom, som medfører smerter og hævelse i leddene hos børn.
English: Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g. BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
Danish: Anden anvendelse af terapeutiske smitstoffer såsom levende svækkede bakterier (fx instillation af BCG i blæren ved behandling af cancer) kan medføre kliniske infektioner herunder disseminerede infektioner.
English: If you have severe persistent asthma, COPD or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.
Danish: Hvis du har svær vedvarende astma, KOL eller er storryger, skal du tale med din læge om, hvorvidt TNF-blokkere er passende for dig.
English: Do not attempt to recap the needle.
Danish: Prøv ikke at genbruge nålen.
English: If you have hearing problem, count 15 seconds from the time you first press the button and then lift the pre-filled pen from the injection site.
Danish: Hvis du er hørehæmmet og ikke kan høre det andet ”klik”, kan du tælle 15 sekunder fra tidspunktet, hvor du trykker på knappen og derefter løfte den fyldte pen fra indsprøjtningsstedet.
English: • heart failure (rare).
Danish: • Hjertesvigt (sjælden).
English: In a limited number of RA patients treated with subcutaneous golimumab over a 6-month period, concomitant use of MTX reduced the apparent clearance of golimumab by approximately 36%.
Danish: Hos et begrænset antal RA-patienter, som blev behandlet med subkutan golimumab i 6 måneder, reducerede samtidig brug af MTX den tilsyneladende clearance af golimumab med ca. 36%.
English: Paediatric population Simponi 100 mg is not recommended in children aged less than 18.
Danish: Pædiatrisk population Simponi 100 mg frarådes til børn under 18 år.
English: Lymphoma and leukaemia
Danish: Lymfom og leukæmi
English: The orange needle guard will extend and lock.
Danish: Den orange nålebeskyttelse udløses og låses på plads.
English: 105 to < 115 0.15 0.2 0.25 0.25 115 to < 125 0.2
Danish: 105 til < 115 0,15 0,2 0,25 0,25 115 til < 125 0,2
English: There is limited safety experience of golimumab treatment in patients who have undergone surgical procedures, including arthroplasty.
Danish: Der er begrænset erfaring med sikkerheden af golimumab-behandling hos patienter, som har gennemgået kirurgiske indgreb inklusive artroplastik.
English: Dizziness may however occur following administration of Simponi (see section 4.8).
Danish: Svimmelhed kan dog forekomme efter administration af Simponi (se pkt.
English: The presence of antibodies to golimumab may increase the risk of injection site reactions.
Danish: Tilstedeværelsen af antistoffer mod golimumab kan øge risikoen for reaktioner på injektionsstedet.
English: Table 6 Key efficacy outcomes from GO-AHEAD at week 16 Improvements in signs and symptoms
Danish: Tabel 6 Nøgleresultater fra GO-AHEAD-studiet ved uge 16 Bedring i tegn og symptomer
English: Percentage of patients Patients in clinical response at week 6
Danish: Procentdel af patienter Patienter med klinisk respons i uge 6
English: Administration of live vaccines to infants exposed to golimumab in utero is not recommended for 6 months following the mother's last golimumab injection during pregnancy (see sections 4.4 and 4.5).
Danish: Administration af levende vacciner til spædbørn, som har været eksponeret for golimumab in utero, anbefales ikke i 6 måneder efter moderens sidste injektion med golimumab under graviditeten (se pkt.
English: Week 24 5% 20%*
Danish: Uge 24 5% 20%*
English: • On rare occasions, a specific and severe type of lymphoma called hepatosplenic T-cell lymphoma has been observed in patients taking other TNF-blockers.
Danish: • I sjældne tilfælde er der set en specifik og alvorlig type lymfom kaldet hepatosplenisk T-celle-lymfom hos patienter, der tager andre TNF-blokkere.
English: The incidence of lymphoma in golimumab-treated patients during the pivotal trials was higher than expected in the general population.
Danish: Hyppigheden af lymfomer hos golimumab-behandlede patienter i de pivotale studier var højere end forventet i den generelle population.
English: • if the dose is more than 2 weeks late, the patient should inject the forgotten dose and a new schedule should be established from the date of this injection.
Danish: • hvis dosis gives mere end 2 uger for sent, skal patienten injicere den glemte dosis, og der skal udarbejdes en ny behandlingsplan ud fra datoen for denne injektion.
English: The use of Simponi in pregnant women is not recommended.
Danish: Simponi frarådes til gravide kvinder.
English: Consistent efficacy was seen in patients regardless of use of DMARDs (MTX, sulfasalazine and/or hydroxychloroquine), HLA-B27 antigen status or baseline CRP levels as assessed by ASAS 20 responses at week 14.
Danish: Der blev observeret samstemmende effekt hos patienterne uanset brugen af DMARD (MTX, sulfasalazin og/eller hydroxychloroquin), HLA-B27 antigenstatus eller baseline-CRP-niveau vurderet på ASAS 20-respons ved uge 14.
English: Golimumab exhibited approximately dose-proportional pharmacokinetics in patients with RA over the dose range of 0.1 to 10.0 mg/kg following a single intravenous dose.
Danish: Golimumab udviste tilnærmelsesvis dosis-proportional farmakokinetik hos patienter med RA efter en enkelt intravenøs dosis i intervallet 0,1 til 10,0 mg/kg.
English: 95 to < 105 0.15 0.2
Danish: 95 til < 105 0,15 0,2
English: Talk to your doctor if you have any questions about giving yourself an injection.
Danish: Tal med din læge, hvis du har spørgsmål angående indsprøjtningerne.
English: In both the AT and OSI populations, the improvements in signs and symptoms, spinal mobility, physical function, quality of life, and productivity observed at week 16 among patients treated with Simponi 50 mg continued in those remaining in the study at week 52.
Danish: I både AT- og OSI-populationen fortsatte bedringen i tegn og symptomer, spinal mobilitet, fysisk funktion, livskvalitet og produktivitet, som blev observeret ved uge 16 hos de patienter, der blev behandlet med Simponi 50 mg, hos de patienter, der stadig var i studiet ved uge 52.