FrancophonIA/ELRC3.0 huggingface dataset:
English: At week 48, children entered a long-term extension.
Danish: Ved uge 48 fortsatte børnene i en længerevarende udvidelsesfase.
English: The primary endpoint, the proportion of children who were ACR Ped 30 responders at week 16 and who did not experience a flare between week 16 and week 48, was not achieved.
Danish: Det primære endepunkt, andelen af børn som udviste pædiatrisk ACR 30-respons ved uge 16, og som ikke oplevede opblussen af sygdommen mellem uge 16 og uge 48, blev ikke opnået.
English: Ulcerative colitis (UC)
Danish: Colitis ulcerosa (UC)
English: Your baby should not receive a ‘live vaccine', such as BCG (used to prevent tuberculosis) within 6 months after your last Simponi injection during pregnancy.
Danish: Dit barn må ikke få en ”levende vaccine”, fx BCG (bruges til at forebygge tuberkulose) inden for 6 måneder efter din sidste Simponi-injektion under graviditeten.
English: Terminal half-life value was estimated to be approximately 12  3 days in healthy subjects and similar values were observed in patients with RA, PsA, AS, or UC.
Danish: Den terminale halveringstid blev estimeret til ca. 12 ± 3 dage hos raske forsøgspersoner, og samme værdier blev observeret hos patienter med RA, PsA, AS eller UC.
English: There is no relevant use of Simponi in patients aged less than 2 years for the indication of pJIA.
Danish: Der er ingen relevant brug af Simponi hos patienter under 2 år for pJIA-indikationen.
English: Golimumab was shown to pass over to breast milk in monkeys, and because human immunoglobulins are excreted in milk, women must not breast feed during and for at least 6 months after golimumab treatment.
Danish: Golimumab er vist at passere over i mælken hos aber, og da humane immunglobuliner udskilles i mælk, må kvinder ikke amme i mindst 6 måneder efter golimumab-behandling.
English: The orange needle guard will lock, and you will not receive the full dose.
Danish: Den orange nålebeskyttelse låses på plads, og du vil ikke få den fulde dosis.
English: It is very important that you tell your doctor if you have ever had TB, or if you have been in close contact with someone who has had TB.
Danish: Det er meget vigtigt, at du fortæller din læge, hvis du nogensinde har haft tuberkulose, eller hvis du har været i tæt kontakt med en person, som har haft TB.
English: • Psoriasis (including on the palms of your hand and/or the soles of your feet and/or in the form of skin blisters)
Danish: • Psoriasis (også på håndflader og/eller fodsåler og/eller i form af blærer på huden)
English: The role of golimumab as a contributing or aggravation factor cannot be excluded.
Danish: Det kan ikke udelukkes, at golimumab har været en medvirkende eller forværrende faktor.
English: Patients who did not achieve clinical response at week 6 in the PURSUIT-Induction studies were dosed Simponi 100 mg every 4 weeks in the PURSUIT-Maintenance study.
Danish: Patienter, som ikke opnåede klinisk respons ved uge 6 i induktionsstudierne PURSUIT-Induction, fik Simponi 100 mg hver 4. uge i vedligeholdelsesstudiet PURSUIT-Maintenance.
English: Get the rest of your equipment ready
Danish: Klargøring af resten af udstyret
English: • The yellow indicator is connected to the plunger of the pre-filled pen.
Danish: • Den gule indikator er forbundet med stemplet i den fyldte pen.
English: • Abnormal liver tests (increased liver enzymes) found during blood tests done by your doctor
Danish: • Unormale levertal (stigning i leverenzymer) ved blodprøver, som tages af din læge
English: The risk of certain side effects is greater with the 100 mg dose compared with the 50 mg dose.
Danish: Risikoen for at få visse bivirkninger er større ved en dosis på 100 mg sammenlignet med en dosis på 50 mg.
English: Insert needle and hold in place
Danish: Stik nålen ind og hold den på plads
English: If this happens, do not drive or use any tools or machines.
Danish: Hvis dette sker, må du ikke køre bil eller betjene nogen form for værktøj eller maskiner.
English: If your doctor decides that you or a caregiver may be able to give your injections of Simponi at home, you should receive training on the right way to prepare and inject Simponi.
Danish: Hvis din læge beslutter, at du eller en plejeperson kan give dig indsprøjtningerne med Simponi derhjemme, skal du have undervisning i, hvordan du forbereder og indsprøjter Simponi korrekt.
English: In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported following golimumab administration.
Danish: Efter markedsføring er der rapporteret alvorlige systemiske overfølsomhedsreaktioner (inklusive anafylaktisk reaktion) efter administration af golimumab.
English: • Remove air bubbles
Danish: • du fjerner luftbobler
English: • It is very important that you tell your doctor if you have ever had TB, or if you have been in close contact with someone who has had or has TB.
Danish: • Det er meget vigtigt, at du fortæller det til din læge, hvis du nogensinde har haft TB, eller hvis du har været i tæt kontakt med en person, som har eller har haft TB.
English: Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin.
Danish: Psoriasisartrit er en betændelsessygdom i leddene, almindeligvis ledsaget af psoriasis, som er en betændelsessygdom i huden.
English: ACR 50 Week 14 10% 35%*
Danish: ACR 50 Uge 14 10% 35%*
English: Signs and symptoms
Danish: Sygdomstegn og symptomer
English: The printed expiration date refers to the last day of the month.
Danish: Den trykte udløbsdato er den sidste dag i den nævnte måned.
English: Check expiry date (see figure 2)
Danish: Tjek udløbsdato (se figur 2)
English: • Pain and discolouration in the fingers or toes
Danish: • Smerte og misfarvning af fingre og tæer
English: In patients with rare hereditary problems of fructose intolerance, the additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account (see section 2).
Danish: Hos patienter med sjælden hereditær fructoseintolerans skal den additive indvirkning af samtidigt administrerede produkter, der indeholder sorbitol (eller fructose), og kostindtag af sorbitol (eller fructose) tages i betragtning (se pkt.
English: Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last golimumab treatment.
Danish: Kvinder i den fertile alder skal anvende sikker prævention for at forhindre graviditet og fortsætte brugen mindst 6 måneder efter sidste golimumab-behandling.
English: However, population pharmacokinetic analysis indicated that concomitant use of NSAIDs, oral corticosteroids or sulfasalazine did not influence the apparent clearance of golimumab.
Danish: Imidlertid viser populationsfarmakokinetiske analyser, at samtidig brug af NSAID, orale kortikosteroider eller sulfasalazin ikke påvirker den tilsyneladende clearance af golimumab.
English: Appropriate screening tests, i.e. tuberculin skin or blood test and chest X-ray, should be performed in all patients (local recommendations may apply).
Danish: Passende screeningsstudier, såsom tuberkulintest, blodprøve og røntgen af thorax, bør udføres hos alle patienter (lokale vejledninger kan være gældende).
English: Health-related quality of life as measured by the physical component score of the SF-36 was also improved significantly at weeks 14 and 24.
Danish: Sundhedsrelateret livskvalitet målt som den fysiske komponent af SF-36 var også signifikant forbedret ved uge 14 og 24.
English: In GO-FORWARD and GO-AFTER, clinically meaningful and statistically significant responses in Disease Activity Scale (DAS)28 were observed at each prespecified time point, at week 14 and at week 24 (p ≤ 0.001).
Danish: I GO-FORWARD og GO-AFTER blev den klinisk relevante og statistisk signifikante respons i Disease Activity Scale (DAS)28 observeret ved hvert af de præspecificerede tidspunkter, uge 14 og uge 24 (p ≤ 0,001).
English: • Front of thighs (recommended)
Danish: • Oversiden af låret (anbefales).
English: Latex sensitivity
Danish: Overfølsomhed over for latex
English: If you pull the pre-filled pen away from your skin, you may not get your full dose of medicine.
Danish: Hvis den fyldte pen løftes fra huden, vil du muligvis ikke få den fulde dosis.
English: Children and adolescents Simponi 100 mg is not recommended for children and adolescents (younger than 18 years).
Danish: Børn og unge Simponi 100 mg frarådes til børn og unge (under 18 år).
English: Choose different sites for these injections and give the injections one right after the other.
Danish: Vælg forskellige steder til disse indsprøjtninger, og giv indsprøjtningerne lige efter hinanden.
English: Confirm with your doctor if you are unsure of your dose.
Danish: Bekræft dosis med din læge, hvis du er i tvivl om din dosis.
English: Patients must be monitored closely for infections including tuberculosis before, during and after treatment with golimumab.
Danish: Patienter skal monitoreres nøje for infektioner inklusive tuberkulose før, under og efter behandling med golimumab.
English: Analyses were performed on both the All Treated (AT, N = 197) and Objective Signs of Inflammation (OSI, N = 158, defined by elevated CRP and/or evidence of sacroiliitis on MRI at baseline) populations.
Danish: Der blev udført analyser på populationerne All Treated (AT, N = 197) og Objective Signs of Inflammation (OSI, N = 158, defineret ved forhøjet CRP og/eller tegn på sakroiliit ved MRI ved baseline).
English: There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates risk estimation.
Danish: Der er en øget baggrundsrisiko for lymfomer og leukæmi hos reumatoid artrit patienter med længerevarende, højaktiv inflammatorisk sygdom, hvilket vanskeliggør risikovurderingen.
English: Among the children who tested positive for antibodies to golimumab, 39% (25/65) had neutralising antibodies.
Danish: Blandt de børn, der blev testet positive for antistoffer mod golimumab, havde 39% (25/65) neutraliserende antistoffer.
English: • Immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
Danish: • Immunsygdomme der kan påvirke lunger, hud og lymfekirtler (viser sig hyppigst som sarkoidose)
English: The efficacy of Simponi was evaluated in two randomised, double-blind, placebo-controlled clinical studies in adult patients.
Danish: Simponis virkning blev vurderet i to randomiserede, dobbeltblindede, placekontrollerede kliniske studier hos voksne patienter.
English: • If you use Simponi or other TNF blockers, your risk for developing lymphoma or another cancer may increase.
Danish: • Behandling med Simponi eller andre TNF-blokkere kan øge din risiko for at udvikle lymfom eller anden form for kræft.
English: Do not share the pre-filled pen with anyone.
Danish: Undlad at dele den fyldte pen med andre.
English: Dates of Simponi treatment
Danish: Datoer for behandling med Simponi
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Simponi in one or more subsets of the paediatric population in ulcerative colitis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Simponi i en eller flere undergrupper af den pædiatriske population med colitis ulcerosa (se pkt.
English: It is important that you tell your baby's doctors and other health care professionals about your Simponi use before the baby receives any vaccine (for more information see section on vaccination).
Danish: Det er vigtigt, at du fortæller barnets læge og andet sundhedspersonale om din behandling med Simponi, før barnet bliver vaccineret (se punktet om vaccination for mere information).
English: Where golimumab use is described by dose, the median duration of follow-up varies (approximately 2 years for 50 mg dose, approximately 3 years for 100 mg dose) as patients may have switched between doses.
Danish: I de tilfælde, hvor brug af golimumab er beskrevet ud fra dosis, varierer den mediane opfølgningsperiode (ca. 2 år for 50 mg dosis, ca. 3 år for 100 mg dosis), da patienterne kan have skiftet mellem doserne.
English: Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections, if feasible.
Danish: Diagnosticering af og administration af empirisk antimykotisk behandling hos disse patienter skal om muligt foretages i samråd med en læge, der har ekspertise i behandling af patienter med invasiv svampeinfektion.
English: • Increase in blood sugar levels
Danish: • Øget blodsukker
English: • Merkel cell carcinoma (a type of skin cancer)
Danish: • Merkelcellekarcinom (en type hudkræft)
English: The results of the maintenance study (PURSUIT-Maintenance) were based on evaluation of 456 patients who achieved clinical response from previous induction with Simponi.
Danish: Resultatet fra vedligeholdelsesstudiet (PURSUIT-Maintenance) var baseret på vurdering af 456 patienter, som opnåede klinisk respons på forudgående Simponi-induktion.
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including golimumab, who are chronic carriers of this virus (i.e. surface antigen positive).
Danish: Reaktivering af hepatitis B er forekommet hos patienter, der fik en TNF-antagonist sammen med golimumab, og som var kroniske bærere af dette virus (dvs. positiv for overfladeantigen).
English: Before you start using Simponi:
Danish: Før du starter med at anvende Simponi:
English: Histidine hydrochloride monohydrate Polysorbate 80
Danish: Histidin-hydrochloridmonohydrat Polysorbat 80
English: If you received Simponi while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately six months after the last dose you received during pregnancy.
Danish: Hvis du var i behandling med Simponi, mens du var gravid, kan dit barn have en øget risiko for at få en sådan infektion i op til ca. 6 måneder efter, du fik din sidste dosis under graviditeten.
English: Children with polyarticular course JIA (rheumatoid factor positive or negative polyarthritis, extended oligoarthritis, juvenile psoriatic arthritis or systemic JIA with no current systemic symptoms) were included in the study.
Danish: Børn med et polyartikulært forløb af JIA (reumatoid-faktorpositiv eller -negativ polyartrit, udvidet oligoartrit, juvenil psoriasisartrit eller systemisk JIA uden aktuelle systemiske symptomer) blev inkluderet i studiet.
English: Patients who have an adequate response should receive 50 mg at week 6 and every 4 weeks thereafter.
Danish: Patienter med tilstrækkeligt respons bør have 50 mg i uge 6 og derefter hver 4. uge.
English: Following a single subcutaneous injection of 100 mg, the absorption of golimumab was similar in the upper arm, abdomen, and thigh, with a mean absolute bioavailability of 51%.
Danish: Efter en enkelt subkutan injektion på 100 mg var absorptionen af golimumab den samme fra overarm, abdomen og lår med en gennemsnitlig absolut biotilgængelighed på 51%.
English: In patients receiving anti-TNF therapy, limited data are available on the response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines.
Danish: Hos patienter, der får anti-TNF-behandling, er der utilstrækkelige data vedrørende respons på vaccination med levende vacciner og vedrørende sekundær overførsel af infektion forårsaget af levende vacciner.
English: Placebo-controlled efficacy data were collected and analysed through week 16.
Danish: Placebokontrollerede data vedrørende virkning blev indsamlet og analyseret til og med uge 16.
English: • Talk to your doctor before you take the fourth dose.
Danish: • Tal med din læge, før du tager den 4. dosis.
English: Following treatment with a TNF-blocking monoclonal antibody during pregnancy, the antibody has been detected for up to 6 months in the serum of the infant born by the treated woman.
Danish: Efter behandling med TNF-blokerende mononukleale antistoffer under graviditeten er antistoffer blevet påvist i serum hos spædbarnet i op til 6 måneder efter fødslen.
English: The dose should be given once a month, on the same date each month.
Danish: Dosis skal gives en gang om måneden på samme dato hver måned.
English: Some of these reactions occurred after the first administration of golimumab.
Danish: Nogle af disse reaktioner opstod efter den første injektion af golimumab.
English: Statistically significant responses in BASDAI 50, 70 and 90 (p ≤ 0.017) were also seen at weeks 14 and 24.
Danish: Der blev også set statistisk signifikant respons i BASDAI 50, 70 og 90 (p ≤ 0,017) i uge 14 og 24.
English: Choose two different sites for these injections (e.g. one injection in the right thigh and the other injection in the left thigh), and give the injections one right after the other.
Danish: Vælg to forskellige steder til disse indsprøjtninger (fx den ene indsprøjtning i højre lår og den anden indsprøjtning i venstre lår), og giv indsprøjtningerne lige efter hinanden.
English: Statistically significant responses in DAS28 were also observed at weeks 14 and 24 (p < 0.05).
Danish: Der blev også observeret statistisk signifikant respons i DAS28 i uge 14 og 24 (p < 0,05).
English: Therefore, a patient who maintained response was in a state of continuous clinical response at each evaluation through week 54.
Danish: Derfor var en patient, som opretholdt respons, i en tilstand af vedvarende klinisk respons ved hver evaluering til og med uge 54.
English: N = number of patients ** p ≤ 0.001 * p ≤ 0.01 defined as a decrease from baseline in the Mayo score by ≥ 30% and ≥ 3 points, accompanied by a decrease in the rectal bleeding subscore of ≥ 1 or a rectal bleeding subscore of 0 or 1.
Danish: N = antal patienter ** p ≤ 0,001 * p ≤ 0,01 Defineret som fald i forhold til baseline i Mayo-scoren med ≥ 30% og ≥ 3 point, ledsaget af et fald i rektal-blødning-subscore på ≥ 1 eller en rektal-blødning-subscore på 0 eller 1.
English: • There may be a small amount of blood or liquid at the injection site.
Danish: • Der kan være en smule blod eller væske ved indsprøjtningsstedet.
English: Simponi treatment resulted in significant improvements in physical function as assessed by changes from baseline in BASFI at weeks 14 and 24.
Danish: Simponi-behandling resulterede i en signifikant forbedring af fysisk funktion, vurderet ved forandringer fra baseline i BASFI ved uge 14 og 24.
English: The number of patients with no new erosions or a change from baseline in total vdH-S Score ≤ 0 was significantly higher in the Simponi treatment group than in the control group (p = 0.003).
Danish: Antallet af patienter uden nye erosioner eller med en ændring i den totale vdH-S-score fra baseline ≤ 0 var signifikant højere i Simponi-behandlingsgruppen end i kontrolgruppen (p = 0,003).
English: If you would like to self inject Simponi, you must be trained by a healthcare professional to prepare an injection and give it to yourself.
Danish: Hvis du ønsker selv at indsprøjte Simponi, skal du først oplæres af sundhedsfagligt personale i, hvordan du forbereder og giver dig selv indsprøjtningen.
English: Responders, % of patients ASAS 20
Danish: Respondenter, % af patienterne ASAS 20
English: • If a caregiver is giving you the injection, they can also use the outer area of the upper arms.
Danish: • Hvis plejepersonale giver dig indsprøjtningen, kan det ydre område af overarmen også anvendes.
English: • Your doctor should test you for HBV
Danish: • Din læge skal teste dig for HBV.
English: Your doctor will record these tests on your Patient Reminder Card.
Danish: Lægen vil notere disse undersøgelser på dit patientinformationskort.
English: A drug-tolerant EIA method was used in the pJIA study for the detection of antibodies to golimumab.
Danish: Der blev anvendt en lægemiddel-tolerant EIA-metode i pJIA-studiet til detektion af antistoffer mod golimumab.
English: Golimumab should not be given to patients with a clinically important, active infection.
Danish: Golimumab bør ikke gives til patienter med en klinisk betydende, aktiv infektion.
English: • Continue to push the pre-filled pen firmly against your skin and press the raised part of the button with your fingers or thumb.
Danish: • Bliv ved med at presse den fyldte pen mod huden og tryk på knappen med dine fingre eller tommelfinger.
English: After your injection
Danish: Efter din indsprøjtning
English: Week 24 28% 60%*
Danish: Uge 24 28% 60%*
English: • Wait 30 minutes to allow the product to reach room temperature
Danish: • Vent 30 minutter, så produktet når stuetemperatur
English: The potential role of TNF-blocking therapy in the development of malignancies is not known.
Danish: Den potentielle rolle for TNF-blokerende behandling for udvikling af malignitet er ukendt.
English: No mutagenicity studies, animal fertility studies nor long-term carcinogenic studies have been conducted with golimumab.
Danish: Der er ikke udført mutagenicitetsstudier, fertilitetsstudier hos dyr og langvarige karcinogenicitetsstudier med golimumab.
English: Turn plunger until the dose line for your prescribed dose lines up with the dose selection notch.
Danish: Drej stemplet, indtil dosismarkøren for din ordinerede dosis står ud for indhakket til valg af dosis.
English: Care should be taken to provide the right strength to ensure that patients are not underdosed or overdosed.
Danish: Det er vigtigt at give den rigtige styrke for at sikre, at patienterne ikke bliver underdoserede eller overdoserede.
English: Improvement in C-reactive protein (CRP) levels were observed relative to placebo groups and treatment with Simponi resulted in significant reductions from baseline in serum levels of IL-6, ICAM-1, matrix-metalloproteinase (MMP)-3 and vascular endothelial growth factor (VEGF) compared to control treatment.
Danish: Relativ forbedring af C-reaktiv protein (CRP)-niveauet blev observeret i forhold til placebogrupperne, og behandling med Simponi resulterede i signifikant reduktion i forhold til baseline af serumniveauer for IL-6, ICAM-1, matrix-metalloproteinase (MMP)-3 og vascular endothelial growth factor (VEGF) sammenlignet med kontrolbehandling.
English: Push and hold the pre-filled pen tip against the skin so the orange needle guard pushes up until it stops.
Danish: Pres og hold spidsen på den fyldte pen ind mod huden, så den orange nålebeskyttelse bliver skubbet op, indtil den stopper.
English: It is important that you tell your baby's doctors and other health care professionals about your Simponi use so they can decide when your baby should receive any vaccine.
Danish: Det er vigtigt, at du fortæller barnets læge og andet sundhedspersonale om din behandling med Simponi, så de kan afgøre, hvornår dit barn kan blive vaccineret.
English: If a patient forgets to inject Simponi on the planned date, the forgotten dose should be injected as soon as the patient remembers.
Danish: Hvis en patient glemmer at injicere Simponi på den planlagte dato, skal den glemte dosis injiceres, så snart patienten husker det.
English: • You can press a cotton ball or gauze over the injection site for 10 seconds.
Danish: • Du kan presse en vatrondel eller gaze på indsprøjtningsstedet i 10 sekunder.
English: Administration of golimumab should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Danish: Behandling med golimumab bør seponeres, hvis en patient udvikler en ny alvorlig infektion eller sepsis, og passende antimikrobiel eller antimykotisk behandling bør initieres, indtil infektionen er under kontrol.