FrancophonIA/ELRC3.0 huggingface dataset:
English: Simponi works by blocking the action of a protein called ‘tumour necrosis factor alpha' (TNF-α).
Danish: Simponi virker ved at blokere virkningen af et protein, der hedder 'tumornekrosefaktor alfa' (TNF).
English: The small number of patients positive for antibodies to golimumab limits the ability to draw definitive conclusions regarding the relationship between antibodies to golimumab and clinical efficacy or safety measures.
Danish: Det lille antal af patienter, som var antistof positive, begrænser muligheden for at drage endelige konklusioner omkring sammenhængen mellem antistoffer mod golimumab og henholdsvis klinisk effekt og sikkerhed.
English: Injection site selection for caregivers if you are not administering the injection yourself (see figure 3)
Danish: Valg af indsprøjtningssted for hjælpere/plejere, hvis du ikke selv foretager indsprøjtningen (se figur 3)
English: • signs of immune system disorders called: lupus (rare).
Danish: • Tegn på sygdom i immunsystemet: lupus (sjælden).
English: It is important that the correct dose is administered as indicated in the posology (see section 4.2).
Danish: Det er vigtigt, at den korrekte dosis administreres som angivet under dosering (se pkt.
English: n reflects randomised patients; actual number of patients evaluable for each endpoint may vary by timepoint.
Danish: n afspejler antal randomiserede patienter; det reelle antal patienter til vurdering ved hvert endepunkt kan variere med tidspunkterne.
English: Concurrent use with other biological therapeutics
Danish: Samtidig brug af anden biologisk behandling
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with golimumab and is positive for antibodies against double-stranded DNA, treatment with golimumab should be discontinued (see section 4.8).
Danish: Hvis en patient udvikler symptomer, der tyder på et lupus-lignende syndrom efter behandling med golimumab, og som er testet positiv for antistoffer mod dobbeltstrenget DNA, skal behandling med golimumab afbrydes (se pkt.
English: Preparing for use of the pre-filled pen
Danish: Forberedelse til anvendelse af den fyldte pen
English: • Do not rub your skin.
Danish: • Gnid ikke på huden.
English: The possibility exists for TNF-blocking agents, including golimumab, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
Danish: Det er muligt, at TNF-blokerende midler inklusive golimumab påvirker forsvarsmekanismen mod infektioner og maligniteter, da TNF medierer inflammation og modulerer cellulært immunrespons.
English: Skin cancers
Danish: Hudcancer
English: Talk to your doctor if you have recently received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer).
Danish: Tal med din læge, hvis du for nylig har fået, eller det er planlagt, at du skal have behandling med et terapeutisk smitstof (fx instillation af BCG til behandling af kræft).
English: Sixty-eight percent (21/31) of antibody-positive patients had neutralising antibodies in vitro.
Danish: 68% (21/31) af de antistofpositive patienter havde neutraliserende antistoffer in vitro.
English: Inject Simponi using the pre-filled pen
Danish: Indsprøjt Simponi med den fyldte pen
English: Active tuberculosis (TB) or other severe infections such as sepsis, and opportunistic infections (see section 4.4).
Danish: Patienter med aktiv tuberkulose (TB) eller andre alvorlige infektioner såsom sepsis og opportunistiske infektioner (se pkt.
English: Patients treated with Simponi should be given the Patient Reminder Card.
Danish: Patienter, som behandles med Simponi, skal have udleveret et patientinformationskort.
English: Of these 70 patients, 64, 46 and 31 patients had an ACR 20/50/70 response, respectively.
Danish: Af disse 70 patienter havde henholdsvis 64, 46 og 31 patienter et ACR-respons på 20/50/70.
English: • Inflamed eye (conjunctivitis)
Danish: • Øjenbetændelse (konjunktivitis)
English: If possible, it is recommended that prior to initiating golimumab therapy, paediatric patients be brought up to date with all immunisations in agreement with current immunisation guidelines (see Vaccinations/therapeutic infectious agents above).
Danish: Det anbefales, at pædiatriske patienter før initiering af behandling med golimumab om muligt bliver bragt ajour med alle vaccinationer i overensstemmelse med gældende vaccinationsvejledninger (se Vaccinationer/terapeutiske smitstoffer ovenfor).
English: 16% 31% p = 0.002 49% 62% Week 52 NA NA NA
Danish: 16% 31% p = 0,002 49% 62% Uge 52 NA NA NA
English: • Stomach and bowel disorders which include inflammation of the stomach lining and colon which may cause fever
Danish: • Mave- og tarmlidelser inklusive betændelse i mavens slimhinde og tyktarmen, som kan give feber
English: For all of the above indications, in patients with RA, PsA, AS, or nr-Axial SpA with a body weight of more than 100 kg who do not achieve an adequate clinical response after 3 or 4 doses, increasing the dose of golimumab to 100 mg once a month may be considered, taking into account the increased risk of certain serious adverse reactions with the 100 mg dose compared with the 50 mg dose (see section 4.8).
Danish: For alle ovennævnte indikationer gælder det, at hos patienter med RA, PsA, AS eller nr-aksial SpA med en kropsvægt på mere end 100 kg, som ikke har opnået tilstrækkeligt klinisk respons efter 3 til 4 doser, kan en forøgelse af golimumabdosis til 100 mg en gang om måneden overvejes under hensyntagen til den øgede risiko for visse alvorlige bivirkninger ved 100 mg dosen sammenlignet med 50 mg dosen (se pkt.
English: Subsequent administrations: ______________________________________________
Danish: Efterfølgende indsprøjtninger: ______________________________________________
English: • Inject the dose promptly after removing the needle cover.
Danish: • Indsprøjt straks dosen, efter du har fjernet nålebeskyttelseshætten.
English: In all situations described below, the benefit/risk balance of golimumab therapy should be very carefully considered.
Danish: I alle situationer beskrevet nedenfor, bør balancen mellem fordele og risici ved golimumab behandling vurderes meget nøje.
English: The induction study (PURSUIT-Induction) evaluated patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) who had an inadequate response to or failed to tolerate conventional therapies, or were corticosteroid dependent.
Danish: Induktionsstudiet (PURSUIT-Induction) vurderede patienter med moderat til svær, aktiv colitis ulcerosa (Mayo-score 6 til 12; endoskopi-subscore ≥ 2) med utilstrækkeligt respons på eller som ikke kunne tåle konventionelle behandlinger, eller som var afhængige af kortikosteroid.
English: In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to CHF have been observed.
Danish: I et klinisk studie med en anden TNF-antagonist er der set forværring af kongestivt hjertesvigt og øget dødelighed pga. kongestivt hjertesvigt.
English: Simponi contains sorbitol (E420).
Danish: Simponi indeholder sorbitol (E420).
English: • Store in a refrigerator (2°C-8°C).
Danish: • Opbevares i køleskab (2°C - 8°C).
English: Caution should be exercised when considering the use of golimumab in patients with a chronic infection or a history of recurrent infection.
Danish: Forsigtighed bør udvises, når brug af golimumab overvejes til patienter med kronisk infektion eller med tilbagevendende infektioner i anamnesen.
English: Common: Alanine aminotransferase increased, aspartate aminotransferase increased Uncommon: Cholelithiasis, hepatic disorders Skin and subcutaneous tissue disorders
Danish: Almindelig: Øget alaninaminotransferase, øget aspartataminotransferase Ikke almindelig: Cholelithiasis, leversygdomme Hud og subkutane væv
English: Simponi is not recommended for children less than 2 years of age with polyarticular juvenile idiopathic arthritis because it has not been studied in this group.
Danish: Simponi frarådes til børn under 2 år med polyartikulær juvenil idiopatisk artrit, da denne gruppe ikke er undersøgt.
English: Non-radiographic axial spondyloarthritis (nr-Axial SpA) Simponi is indicated for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Danish: Non-radiografisk aksial spondylartrit (nr-aksial SpA) Simponi er indiceret til behandling af voksne med svær, aktiv non-radiografisk aksial spondylartrit med objektive tegn på inflammation indikeret ved forhøjet C-reaktivt protein (CRP) og/eller påvist ved MRI (MR-scanning), som ikke har responderet tilstrækkeligt på eller er intolerante over for nonsteroide antiinflammatoriske stoffer (NSAID).
English: The primary endpoint was the percentage of patients achieving Ankylosing Spondylitis Assessment Study Group (ASAS) 20 response at week 14.
Danish: Det primære endepunkt var den procentdel af patienter, der opnåede Ankylosing Spondylit Assessment Study Group (ASAS) 20 respons i uge 14.
English: At week 52, patients entered an open label long-term extension in which patients receiving placebo + MTX who had at least 1 tender or swollen joint were switched to Simponi 50 mg + MTX.
Danish: Ved uge 52 påbegyndte patienterne en længerevarende open-label-fortsættelse, i hvilken patienter, som fik placebo + MTX, og som havde mindst et ømt eller hævet led, skiftede til Simponi 50 mg + MTX.
English: Patients enrolled in this study had active disease despite current or previous NSAID or DMARD therapy and had not previously been treated with anti-TNF therapy.
Danish: Patienter, der var inkluderet i dette studie, havde aktiv sygdom, selvom de var i behandling eller havde været i behandling med NSAID eller DMARD, og var ikke tidligere behandlet med anti-TNF.
English: • You may get infections more easily while using Simponi.
Danish: • Du kan muligvis lettere få infektioner, når du er i behandling med Simponi.
English: Of patients that continued in the study extension and had evaluable samples through week 228, antibodies to golimumab were detected in 4% (23/604) of golimumab treated patients.
Danish: Hos de patienter, som fortsatte i studieforlængelsen og havde evaluerbare prøver til og med uge 228, blev der detekteret antistoffer mod golimumab hos 4% (23/604) af de golimumab-behandlede patienter.
English: Simponi 50 mg administered once a month, on the same date each month, for children with a body weight of at least 40 kg. A 45 mg/0.45 mL pre-filled pen is available for administration to children with polyarticular juvenile idiopathic arthritis weighing less than 40 kg.
Danish: Simponi 50 mg administreres en gang om måneden, på samme dato hver måned, til børn med en kropsvægt på mindst 40 kg. En 45 mg/0,45 ml fyldt pen er tilgængelig til administration hos børn med polyartikulær juvenil idiopatisk artrit, der vejer under 40 kg.
English: Do not press the plunger while inserting the needle.
Danish: Undlad at trykke på stemplet, mens du indstikker nålen.
English: Keep pushing the pre-filled pen against the skin.
Danish: Fortsæt med at presse den fyldte pen ind imod huden.
English: 1.1 Prior to Simponi treatment:
Danish: 1.1 Før behandling med Simponi
English: • 1 Sharps container (See Step 3)
Danish: • 1 kanylebeholder (se trin 3)
English: Common: Bone fractures
Danish: Almindelig: Knoglebrud
English: • Do not remove the cap from the pre-filled pen until immediately before the injection.
Danish: • Fjern ikke hætten fra den fyldte pen før umiddelbart inden indsprøjtning.
English: • Narrowing of the blood vessels in the heart
Danish: • Forsnævring af blodkar i hjertet
English: Simponi treatment resulted in significant improvement in physical function as assessed by HAQ DI, as well as significant improvements in health-related quality of life as measured by the physical and mental component summary scores of the SF-36.
Danish: Simponibehandling resulterede i signifikant forbedret fysisk funktion vurderet ved HAQ DI, samt signifikant forbedret sundhedsrelateret livskvalitet målt ved den fysiske og mentale komponent af SF-36.
English: This Patient Reminder Card contains important safety information that you need to be aware of before and during treatment with Simponi.
Danish: Dette informationskort indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under behandling med Simponi.
English: • When you are ready to inject, twist the cap slightly to break the security seal.
Danish: • Når du er klar til at indsprøjte, skal du vride hætten en anelse, så sikkerhedsforseglingen brydes.
English: Continued therapy should be reconsidered in children who show no evidence of therapeutic benefit within this time period.
Danish: Fortsat behandling bør genovervejes hos børn, som ikke viser tegn på terapeutisk virkning inden for denne periode.
English: Concurrent administration of TNF-antagonists and abatacept In clinical studies concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections including serious infections compared to TNF-antagonists alone, without increased clinical benefit.
Danish: Samtidig administration af TNF-antagonister og abatacept Samtidig anvendelse af TNF-antagonister og abatacept har i kliniske studier været forbundet med en øget risiko for infektioner inklusive alvorlige infektioner uden en øget klinisk fordel sammenlignet med TNF-antagonister alene.
English: A patient who requires surgery while on golimumab should be closely monitored for infections, and appropriate actions should be taken.
Danish: En patient, som har behov for operation under golimumabbehandling, bør følges nøje for infektioner, og passende forholdsregler bør tages.
English: • Patients with severe persistent asthma, chronic obstructive pulmonary disease (COPD), or are heavy smokers may be at increased risk for cancer with Simponi treatment.
Danish: • Patienter med svær vedvarende astma, kronisk obstruktiv lungesygdom (KOL), eller patienter som er storrygere, kan have øget risiko for kræft ved behandling med Simponi.
English: All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course.
Danish: Alle patienter med colitis ulcerosa, som har øget risiko for at få dysplasi eller colonkarcinom (fx patienter med længerevarende colitis ulcerosa eller primær skleroserende kolangit), eller som har dysplasi eller colonkarcinom i anamnesen, bør screenes for dysplasi regelmæssigt før behandling og under sygdomsforløbet.
English: The majority of children did not experience a flare between week 16 and week 48 (59% in the Simponi + MTX and 53% in the placebo + MTX groups, respectively; p = 0.41).
Danish: Størstedelen af børnene oplevede ikke opblussen af sygdommen mellem uge 16 og uge 48 (henholdsvis 59% i gruppen med Simponi + MTX og 53% i gruppen med placebo + MTX; p = 0,41).
English: Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Danish: Det er vist, at Simponi i kombination med MTX nedsætter progressionshastigheden for ledbeskadigelse målt ved røntgen og fremmer den fysiske funktionsevne.
English: Each pack is provided with instructions for use that fully describe the use of the pen or the syringe.
Danish: Hver pakning leveres med en brugsvejledning, der fuldt beskriver brugen af pennen eller injektionssprøjten.
English: There were no patients age 45 and over in the non-radiographic axial spondyloarthritis (nr-Axial SpA) study.
Danish: Der var ingen patienter i alderen 45 år eller derover i non-radiografisk aksial spondylartrit (nr-aksial SpA)-studiet.
English: Concurrent administration of TNF-antagonists and anakinra Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNF-blocking agent, etanercept, with no added clinical benefit.
Danish: Samtidig administration af TNF-antagonister og anakinra Der blev observeret alvorlige infektioner og neutropeni i kliniske studier ved samtidig anvendelse af anakinra og et andet TNF-blokerende middel, etanercept, uden nogen øget klinisk fordel.
English: Do not press on the orange needle guard before the injection.
Danish: Undlad at trykke på den orange nålebeskyttelse før indsprøjtningen.
English: • Combined low platelet, red, and white blood cell count
Danish: • Kombineret lavt antal blodplader, røde og hvide blodceller
English: Tell your doctor straight away if you notice any of the following serious side effects of Simponi which include:
Danish: Fortæl det straks til din læge, hvis du bemærker en eller flere af følgende alvorlige bivirkninger med Simponi:
English: Storage information Store in refrigerator at 2° to 8°C.
Danish: Opbevaring Opbevares i køleskab ved 2°C - 8°C.
English: At week 24 improvements in parameters of peripheral activity characteristic of psoriatic arthritis (e.g. number of swollen joints, number of painful/tender joints, dactylitis and enthesitis) were seen in the Simponi-treated patients.
Danish: Ved uge 24 sås der forbedringer i parametrene for perifer aktivitet, karakteristiske for psoriasisartrit (fx antallet af hævede led, antallet af smertefulde/ømme led, dactylitis og enthesitis) hos patienter behandlet med Simponi.
English: Invasive fungal infections
Danish: Invasive svampeinfektioner
English: After proper training in subcutaneous injection technique, patients may self-inject if their physician determines that this is appropriate, with medical follow-up as necessary.
Danish: Hvis lægen finder det hensigtsmæssigt, kan patienten selv injicere efter passende træning i subkutan injektionsteknik - med den nødvendige lægelige opfølgning.
English: In the controlled periods of pivotal trials, 5.4% of golimumab-treated patients had injection site reactions compared with 2.0% in control patients.
Danish: I de kontrollerede perioder af de pivotale studier havde 5,4% af de golimumab-behandlede patienter reaktioner på injektionsstedet sammenlignet med 2,0% hos kontrolpatienter.
English: At week 52, patients entered an open label long-term extension.
Danish: Ved uge 52 påbegyndte patienterne en længerevarende open-label-fortsættelse.
English: Injection site reactions generally did not necessitate discontinuation of the medicinal product.
Danish: Det har generelt ikke været nødvendigt at afbryde behandlingen med lægemidlet pga. reaktioner på injektionsstedet.
English: IMPORTANT: Do not press on the orange needle guard before the injection.
Danish: VIGTIGT: Undlad at trykke på den orange nålebeskyttelse før indsprøjtningen.
English: Some cases had a fatal outcome.
Danish: Nogle tilfælde havde dødelig udgang.
English: At week 16, patients entered an open label period in which all patients received Simponi 50 mg administered subcutaneously every 4 weeks through week 48 with efficacy assessments performed through week 52 and safety follow-up through week 60.
Danish: Ved uge 16 gik patienterne ind i en åben periode, hvor alle patienter fik Simponi 50 mg givet subkutant hver 4. uge til og med uge 48 med vurderinger af virkning til og med uge 52 og sikkerhedsopfølgning til og med uge 60.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Simponi.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Simponi.
English: Among 146 patients randomised to Simponi 50 mg, 70 were still on this treatment at week 104.
Danish: Blandt 146 patienter, som var randomiseret til Simponi 50 mg, var 70 stadig i denne behandling ved uge 104.
English: Put your used pre-filled pen in a sharps disposal container right away after use.
Danish: Læg den brugte fyldte pen i en kanylebeholder straks efter brug.
English: Check security seal
Danish: Tjek sikkerhedsforsegling
English: • Inflammation of the blood vessels in your skin which results in rash
Danish: • Betændelse i blodkarrene i huden, hvilket resulterer i udslæt.
English: The needle cover on the pre-filled pen is manufactured from dry natural rubber containing latex, and may cause allergic reactions in individuals sensitive to latex.
Danish: Nålebeskyttelseshætten på den fyldte pen er fremstillet af tør naturgummi, som indeholder latex, og kan give allergiske reaktioner hos personer, der er overfølsomme for latex.
English: In patients with newly diagnosed dysplasia treated with golimumab, the risks and benefits to the individual patient must be carefully reviewed and consideration should be given to whether therapy should be continued.
Danish: Hos patienter med nydiagnosticeret dysplasi, som er blevet behandlet med golimumab, skal benefit/risk-forholdet hos den enkelte patient vurderes nøje, og det skal overvejes, om behandlingen skal fortsætte.
English: Simponi 50 mg treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment at week 24 as measured by change from baseline in total modified vdH-S Score (mean ± SD score was 0.27 ± 1.3 in the placebo group compared with -0.16 ± 1.3 in the Simponi group; p = 0.011).
Danish: Behandling med Simponi 50 mg reducerede progressionshastigheden af ødelæggelse af de perifere led sammenlignet med placebo ved uge 24, målt i ændring i total modificeret vdH-S score (middel ± SD score var 0,27 ± 1,3 i placebogruppen sammenlignet med -0,16 ± 1,3 i Simponigruppen; p = 0,011) i forhold til baseline.
English: Do not pull back on the plunger at any time.
Danish: Træk på intet tidspunkt tilbage i stemplet.
English: For information regarding the polyarticular juvenile idiopathic arthritis indication, please see the Simponi 50 mg SmPC.
Danish: For information om indikationen polyartikulær juvenil idiopatisk artrit se SmPC for Simponi 50 mg.
English: The solution is clear to slightly opalescent, colourless to light yellow.
Danish: Opløsningen er klar til let opaliserende, farveløs til lys gul.
English: 2% 9% p = 0.009 16% 24% Week 52 NA NA NA
Danish: 2% 9% p = 0,009 16% 24% Uge 52 NA NA NA
English: In the controlled and uncontrolled periods of pivotal trials through 1 year of follow-up, 3.5% of golimumab-treated patients and 2.3% of control patients were newly ANA-positive (at titres of 1:160 or greater).
Danish: I de kontrollerede og ikke-kontrollerede perioder af de pivotale studier til og med 1 års follow-up blev 3,5% af de golimumab-behandlede patienter og 2,3% af kontrolpatienterne testet ANA-positive (titer 1:160 eller mere).
English: At week 48, 53% and 55% of children in the Simponi + MTX group and placebo + MTX group, respectively, were ACR Ped 30 responders, and 40% and 28% of children in the Simponi + MTX group and placebo + MTX group, respectively, achieved inactive disease.
Danish: Ved uge 48 udviste henholdsvis 53% og 55% af børnene i Simponi + MTX-gruppen og placebo + MTX-gruppen pædiatrisk ACR 30-respons, og henholdsvis 40% og 28% af børnene i Simponi + MTX-gruppen og placebo + MTX-gruppen opnåede inaktiv sygdom.
English: In patients weighing less than 80 kg, a greater proportion of patients who received 50 mg maintenance therapy showed sustained clinical remission compared with those who received placebo.
Danish: Hos patienter, der vejede < 80 kg, udviste en større del af de patienter, der fik 50 mg vedligeholdelsesbehandling, vedvarende klinisk remission sammenlignet med dem, der fik placebo.