FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients were required to be on a stable dose of 6-MP, AZA or MTX (35% were also receiving corticosteroids at baseline).
Danish: Alle patienterne skulle være på en stabil dosis af 6-MP, AZA eller MTX (35 % fik også kortiokosteroid ved baseline).
English: Seizure, neuropathy.
Danish: Kramper, neuropati.
English: In the first study, (study 8), improvement in signs and symptoms was also observed as early as week 2.
Danish: I det første studie (studie 8) sås forbedring af tegn og symptomer så tidligt som i uge 2.
English: This includes multiple sclerosis, Guillain-Barré syndrome, if you have fits or have been diagnosed with ‘optic neuritis'.
Danish: Dette inkluderer dissemineret sklerose, Guillain-Barré syndrom, hvis du har krampeanfald eller har fået stillet diagnosen ”optisk neuritis” (betændelse i synsnerven).
English: The pooled data analysis from study 6 and study 7 and their extensions, analysed from baseline through 54 weeks, demonstrated a reduction of ulcerative colitis-related hospitalisations and surgical procedures with infliximab treatment.
Danish: Den samlede data analyse for studie 6 og studie 7 og deres forlængelser, som blev analyseret fra baseline til uge 54, viste en reduktion af colitis ulcerosa-relaterede hospitalsindlæggelser og kirurgiske indgreb med infliximab-behandling.
English: • Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Zessly treatment.
Danish: • Patienter med KOL og patienter, som er storrygere, kan have en øget risiko for at udvikle kræft under behandling med Zessly.
English: Number of patients evaluated for ALT.
Danish: 3 Antal patienter, som er evalueret for ALAT.
English: Zessly is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Danish: Zessly er indiceret til behandling af aktiv og progressiv psoriasis arthritis hos voksne patienter, hvor respons på tidligere DMARD-behandling har været utilstrækkelig.
English: In this situation, do not return to the refrigerated storage again.
Danish: I denne situation må det ikke sættes tilbage i køleskab.
English: • Tell your doctor before you are given Zessly if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.
Danish: • Fortæl din læge, før du får Zessly, hvis du nogensinde har boet eller rejst i et område, hvor infektioner kaldet histoplasmose, kokcidioidomykose eller blastomykose er almindelige.
English: For storage conditions up to 30°C before reconstitution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold op til 30 °C før rekonstitution af lægemidlet, se pkt.
English: At 102 weeks there were 49 subjects still on infliximab treatment and among those, 30 (61%) were BASDAI 50 responders.
Danish: I 102. uge var 49 patienter stadig på infliximab-behandling, og blandt disse var 30 (61 %) BASDAI 50 responders.
English: Viral infection (e.g. influenza, herpes virus infection).
Danish: Virusinfektion (fx influenza, herpes virus infektioner).
English: 2 weeks after your 1st treatment
Danish: 2 uger efter din 1. dosis
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C - 8°C.
Danish: Hvis det ikke anvendes straks, er opbevaringstiderne og -betingelserne efter anbrud indtil anvendelse brugerens ansvar, og de bør ikke overskride 24 timer ved 2 °C - 8 °C.
English: Percentage of subjects in clinical remission and sustained remission
Danish: Procent forsøgspersoner i klinisk remission og vedvarende remission
English: Calculate the dose and the number of Zessly vials needed.
Danish: Beregn dosis og det nødvendige antal Zessly-hætteglas.
English: In a clinical study of patients with rheumatoid arthritis, infusions were to be administered over 2 hours for the first 3 infusions.
Danish: I et klinisk studie hos patienter med reumatiod arthritis skulle de 3 første infusioner indgives over 2 timer.
English: You may receive some vaccines during treatment with Zessly but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Zessly because they may cause infections.
Danish: Der er visse vaccinationer, du kan få, mens du er i behandling med Zessly, men du må ikke få levende vacciner (vacciner der indeholder et levende men svækket smitstof), da de kan give infektioner.
English: This patient reminder card contains important safety information that you need to be aware of before and during treatment with Zessly.
Danish: Dette patientinformationskort indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under behandling med Zessly.
English: • In case you have received Zessly while you were pregnant, it is important that you inform your baby's doctor about it before your baby receives any vaccine.
Danish: • Hvis du har fået Zessly, mens du var gravid, er det vigtigt, at du informerer dit barns læge om det, før dit barn bliver vaccineret.
English: In patients treated with Zessly, an invasive fungal infection such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis should be suspected if they develop a serious systemic illness, and a physician with expertise in the diagnosis and treatment of invasive fungal infections should be consulted at an early stage when investigating these patients.
Danish: Hos patienter behandlet med Zessly bør en invasiv svampeinfektion såsom aspergillose, candidiasis, pneumocystose, histoplasmose, kokcidioidomykose eller blastomykose mistænkes, hvis en alvorlig systemisk sygdom udvikles, og en læge med ekspertise i diagnosticering og behandling af invasive svampeinfektioner bør konsulteres på et tidligt stadie, når disse patienter undersøges.
English: Clinical remission at week 8a Clinical remission at week 30a Sustained remission (in remission at both week 8 and week 30)a
Danish: Klinisk remission i uge 8a Klinisk remission i uge 30a Vedvarende remission (i remission både i uge 8 og uge 30)a
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Zessly and is positive for antibodies against double-stranded DNA, further treatment with Zessly must not be given (see section 4.8).
Danish: Hvis en patient udvikler symptomer, der viser tegn på et lupus-lignende syndrom efter behandling med Zessly og er positiv over for antistoffer mod dobbeltstrenget DNA, må behandling med Zessly ikke fortsættes (se pkt.
English: No physical biochemical compatibility studies have been conducted to evaluate the coadministration of Zessly with other agents.
Danish: Der er ikke gennemført biokemiske forligelighedsstudier for at vurdere samtidig indgivelse af Zessly med andre midler.
English: Study 1 evaluated responses at 30, 54 and 102 weeks in a placebo-controlled study of 428 patients with active rheumatoid arthritis despite treatment with methotrexate.
Danish: Studie 1 evaluerede responset ved ugerne 30, 54 og 102 i en placebokontrolleret studie hos 428 patienter med aktiv reumatoid arthrit på trods af behandling med methotrexat.
English: Table 1 Undesirable effects in clinical studies and from post-marketing experience
Danish: Tabel 1 Bivirkninger i kliniske studier og efter markedsføring
English: In the second clinical study (study 9), improvement in signs and symptoms was observed as early as week 2.
Danish: I det andet kliniske studie (studie 9) sås forbedring af tegn og symptomer så tidligt som i uge 2.
English: There was one reported malignancy amongst 77 control patients (median duration of follow-up 0.8 years; incidence 1.3% [95% CI 0.03%-7.0%]).
Danish: Der var en rapporteret malign sygdom blandt 77 kontrolpatienter (median opfølgningsperiode 0,8 år; incidence 1.3 % [95 % CI 0,03 %- 7,0 %]).
English: Percentage of subjects in clinical response and in sustained clinical response
Danish: Procent forsøgspersoner i klinisk respons og i vedvarende klinisk respons
English: Concurrent administration with other biological therapeutics
Danish: Samtidig administration af anden biologisk behandling
English: The usual dose is 3 mg for every kg of body weight.
Danish: Den sædvanlige dosis er 3 mg pr. kg kropsvægt.
English: • Circulation problems such as low or high blood pressure,
Danish: • Kredsløbsproblemer såsom for lavt eller for højt blodtryk
English: to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Study 12 evaluated the efficacy of infliximab induction therapy in 249 patients with plaque psoriasis that had previously received PUVA or systemic therapy.
Danish: Studie 12 vurderede effekten af infliximab induktionsbehandling hos 249 patienter med plaque psoriasis, som tidligere havde fået PUVA eller systemisk behandling.
English: In infants exposed in utero to infliximab, fatal outcome due to disseminated Bacillus CalmetteGuérin (BCG) infection has been reported following administration of BCG vaccine after birth.
Danish: Hos spædbørn, der i uterus er blevet eksponeret for infliximab, er der rapporteret om letalt udfald på grund af dissemineret infektion forårsaget af Calmette-Guérins bakterie (BCG) efter administration af BCG-vaccine efter fødslen.
English: Infliximab does not cross react with TNFα from species other than human and chimpanzee.
Danish: Infliximab krydsreagerer ikke med TNFα fra andre arter end mennesker og chimpanser.
English: There is insufficient information regarding the concomitant use of infliximab with other biological therapeutics used to treat the same conditions as infliximab.
Danish: Der foreligger ikke tilstrækkelig information om samtidig brug af infliximab og andre biologiske lægemidler til behandling af de samme lidelser som infliximab.
English: Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for C-section section (1.50, 1.14-1.96; p = 0.0032), preterm birth (1.48, 1.05-2.09; p = 0.024), small for gestational age (2.79, 1.54-5.04; p = 0.0007), and low birth weight (2.03, 1.41-2.94; p = 0.0002) was observed in women exposed during pregnancy to infliximab (with or without immunomodulators/corticosteroids, 270 pregnancies) as compared to women exposed to immunomodulators and/or corticosteroids only (6,460 pregnancies).
Danish: På basis af et observationsstudie fra Nordeuropa blev der observeret øget risiko (OR, 95 % CI; p-værdi) for kejsersnit (1,50; 1,14-1,96; p = 0,0032), for tidligt fødte børn (1,48; 1,05-2,09; p = 0,024), børn født små i forhold til gestationsalder (2,79; 1,54-5,04; p = 0,0007) og lav fødselsvægt (2,03; 1,41-2,94; p = 0,0002) hos kvinder, som blev eksponeret for infliximab under graviditeten (med eller uden immunmodulatorer/kortikosteroider, 270 graviditeter) sammenlignet med kvinder, som udelukkende blev eksponeret for immunmodulatorer/kortikosteroider (6.460 graviditeter).
English: Table 10 Summary of PASI response, PGA response and percent of patients with all nails cleared at weeks 10, 24, and 50.
Danish: Tabel 10 Resumé af PASI respons, PGA-respons og andel patienter, hvis negle alle var fri for psoriasis i uge 10, 24 og 50.
English: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease and ulcerative colitis), Merkel cell carcinoma.
Danish: Hepatosplenisk T-celle-lymfom (primært hos unge og unge voksne mænd med Crohns sygdom og colitis ulcerosa), Merkelcellekarcinom.
English: Infections were reported in 31 (51.7%) of 60 treated patients in the paediatric ulcerative colitis trial and 22 (36.7%) required oral or parenteral antimicrobial treatment.
Danish: Der blev rapporteret om infektioner hos 31 (51,7 %) af 60 behandlede patienter i studiet med colitis ulcerosa hos børn, og 22 (36,7 %) krævede oral eller parenteral antimikrobiel behandling.
English: • It is important that you tell your baby's doctors and other health care professionals about your Zessly use before your baby is given any vaccine.
Danish: • Det er vigtigt, at du fortæller dit barns læge og andet sundhedspersonale, at du har fået Zessly, før barnet bliver vaccineret.
English: Zessly contains the active substance infliximab.
Danish: Zessly indeholder det aktive stof infliximab.
English: Hypersensitivity to the active substance, to other murine proteins, or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, over for andre murine proteiner eller over for et eller flere af hjælpestofferne anført i pkt.
English: Abdominal pain, nausea.
Danish: Abdominalsmerter, kvalme.
English: Zessly contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially ‘sodium-free'.
Danish: Zessly indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. det er i det væsentlige ”natriumfrit”.
English: Because of the nature of the adverse reactions seen with combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNFα-blocking agents.
Danish: Grundet egenskaberne af bivirkningerne set ved kombinationsbehandlingen med etanercept og anakinra, kan lignende toksiciteter muligvis forekomme ved kombination af anakinra med andre TNFα -blokerende midler.
English: Table 8 Effects on clinical response in adult patients with moderately to severely active ulcerative colitis, clinical remission and mucosal healing at weeks 8 and 30.
Danish: Tabel 8 Effekt på klinisk respons hos voksne patienter med moderat til svært aktiv ulcerøs colitis, klinisk remission og slimhindeheling i uge 8 og 30.
English: Zessly is supplied as a glass vial containing a powder for concentrate for solution for infusion (powder for concentrate).
Danish: Zessly leveres som et hætteglas (glasflaske) indeholdende et pulver til koncentrat til infusionsvæske, opløsning (pulver til koncentrat).
English: In the 3 mg/kg Infliximab group, 4 out of 60 patients had a serious infusion reaction and 3 patients reported a possible anaphylactic reaction (2 of which were among the serious infusion reactions).
Danish: I 3 mg/kg infliximab-gruppen fik 4 ud af 60 patienter en alvorlig infusionsreaktion, og 3 patienter rapporterede en mulig anafylaktisk reaktion (ud af disse var 2 blandt de alvorlige infusionsreaktioner).
English: Please read the Zessly ‘Package Leaflet' carefully before you start using this medicine.
Danish: Læs indlægssedlen for Zessly grundigt, inden du begynder at tage medicinen.
English: Upon removal from refrigerated storage, Zessly must not be returned to refrigerated storage.
Danish: Når Zessly er taget ud af køleskabet, må det ikke sættes tilbage på køl igen.
English: Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Danish: Infliximab er et kimerisk monoklonalt human-murin IgG1-antistof fremstillet i ovarieceller fra kinesiske hamstre (Chinese Hamster Ovary, CHO) ved rekombinant DNA-teknologi.
English: • If your doctor feels that you are at risk for TB, you may be treated with medicines for TB
Danish: • Hvis din læge tror, at du har risiko for at få TB, kan du blive behandlet med lægemidler mod TB, inden du får Zessly.
English: Following administration of 5 mg/kg infliximab every 8 weeks, the predicted median steady-state infliximab exposure (area under concentrationtime curve at steady state, AUCss) in paediatric patients aged 6 years to 17 years was approximately 20% lower than the predicted median steady-state drug exposure in adults.
Danish: Efter administration af infliximab 5 mg/kg hver 8. uge var den forventede mediane steady-state infliximab-eksponering (arealet under koncentrationstids-kurven ved steady-state, AUCss) hos pædiatriske patienter i alderen 6 til 17 år ca. 20 % lavere end den forventede mediane steady-state lægemiddel-eksponering hos voksne.
English: Juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis
Danish: Juvenil idiopatisk arthritis, psoriasis arthritis og ankyloserende spondylitis
English: • Treatment with TNF blockers such as Zessly may result in reactivation of hepatitis B virus in patients who carry this virus, which can be life-threatening in some cases.
Danish: • Behandling med TNF-blokkere, såsom Zessly, kan medføre, at hepatitis B igen bliver aktiv hos patienter, som bærer denne virus.
English: If you are not sure, talk to your doctor before you are given Zessly.
Danish: Hvis du er i tvivl, så tal med din læge, før du får Zessly.
English: Key efficacy results for study 10 and study 11 in patients with active psoriatic arthritis are shown in Table 9 below:
Danish: De vigtigste resultater for effekt i studie 10 og studie 11 hos patienter med aktiv psoriatisk arthritis er vist i tabel 9 nedenfor:
English: Zessly should be administered intravenously.
Danish: Zessly administreres intravenøst.
English: EU/1/18/1280/001 1 vial 100 mg EU/1/18/1280/002 2 vials 100 mg EU/1/18/1280/003 3 vials 100 mg EU/1/18/1280/004 4 vials 100 mg EU/1/18/1280/005 5 vials 100 mg
Danish: EU/1/18/1280/001 1 hætteglas 100 mg EU/1/18/1280/002 2 hætteglas 100 mg EU/1/18/1280/003 3 hætteglas 100 mg EU/1/18/1280/004 4 hætteglas 100 mg EU/1/18/1280/005 5 hætteglas 100 mg
English: Clinical response at week 8a Clinical response at week 30a Sustained response (clinical response at both week 8 and week 30)a
Danish: Klinisk respons i uge 8a Klinisk respons i uge 30a Vedvarende respons (klinisk respons både i uge 8 og uge 30)a
English: Placebo patients in the two Phase III studies in Crohn's disease, received an initial dose of 5 mg/kg infliximab at study start and were on placebo in the maintenance phase.
Danish: 2 Placebo-patienter i de to fase III-studier med Crohns sygdom fik som startdosis 5 mg/kg infliximab ved studiets begyndelse og var på placebo i vedligeholdelsesfasen.
English: At week 16, 47 placebo patients with < 10% improvement from baseline in both swollen and tender joint counts were switched to infliximab induction (early escape).
Danish: I uge 16 blev 47 placebopatienter med < 10 % forbedring fra udgangspunktet i både hævede og ømme led flyttet til infliximab-induktion (tidlig overflytning).
English: By week 26, twenty weeks after the last induction dose, 30% of patients in the 5 mg/kg group and 13.8% of patients in the 3 mg/kg group were PASI 75 responders.
Danish: I uge 26, tyve uger efter den sidste induktionsdosis, var 30% af patienterne i 5 mg/kg gruppen og 13,8 % af patienterne i 3 mg/kg gruppen PASI 75 respondere.
English: The reduction in incidence of colectomy was also examined in another randomised, double-blind study in hospitalised patients (n = 45) with moderately to severely active ulcerative colitis who failed to respond to intravenous corticosteroids and who were therefore at higher risk for colectomy.
Danish: Reduktionen i hyppigheden af kolektomi blev også undersøgt i et anden randomiseret, dobbelblind studie af hospitaliserede patienter (n = 45) med moderat til svær aktiv colitis ulcerosa, som ikke responderede på intravenøse kortikosteroider, og som derfor havde større risiko for kolektomi.
English: The efficacy was assessed in a randomised, double-blinded, placebo-controlled study in 94 patients with fistulising Crohn's disease who had fistulas that were of at least 3 months' duration.
Danish: Effekten blev også vurderet i et randomiseret, dobbeltblind, placebokontrolleret studie hos 94 patienter med fistulerende Crohns sygdom, som havde fistler af mindst 3 måneders varighed.
English: At week 24, all placebo-treated patients crossed over to infliximab induction.
Danish: I uge 24 blev alle placebobehandlede patienter flyttet over til infliximab-induktion.
English: Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha.
Danish: Infliximab er et monoklonalt antistof - en type protein, der binder sig til et specifikt mål i kroppen kaldet TNF (tumornekrosefaktor) alfa.
English: Infliximab was studied in a clinical study in 120 patients (age range: 4-17 years old) with active juvenile rheumatoid arthritis despite methotrexate.
Danish: Infliximab blev undersøgt i et klinisk studie med 120 patienter (alder: 4-17 år) med aktiv juvenil reumatoid arthrithis til trods for behandling med methotrexat.
English: If serious reactions occur, symptomatic treatment must be given and further Zessly infusions must not be administered (see section 4.8).
Danish: Hvis alvorlige reaktioner opstår, skal symptomatisk behandling gives, og der må ikke gives yderligere Zesslyinfusioner (se pkt.
English: b Based on patients with PASI ≥ 2.5 at baseline for study 10, and patients with ≥ 3% BSA
Danish: b Baseret på patienter med PASI > 2.5 ved baseline for studie 10, og patienter med > 3 % BSA psoriasis hud påvirkning ved baseline af studie 11.
English: In the Phase IIIb trial in Crohn's disease, placebo patients received AZA 2.5 mg/kg/day as active control in addition to placebo infliximab infusions.
Danish: I fase IIIb-studiet med Crohns sygdom fik placebopatienterne AZA 2,5 mg/kg/dag som aktiv kontrol i tillæg til placebo-infliximab-infusioner.
English: In Crohn's disease, experience with re-administration if signs and symptoms of disease recur is limited and comparative data on the benefit/risk of the alternative strategies for continued treatment are lacking.
Danish: I Crohns sygdom er erfaring med fornyet indgift efter genopdukkende sygdomstegn og symptomer begrænset, og sammenlignende data vedrørende gavn versus risici på de forskellige strategier savnes.
English: Patients should be closely monitored and Zessly must not be continued in patients who develop new or worsening symptoms of heart failure (see sections 4.3 and 4.8).
Danish: Patienter bør følges nøje, og Zessly må ikke fortsættes hos patienter, som udvikler nye eller forværrede symptomer på hjerteinsufficiens (se pkt.
English: Check that the solution is colourless to light brown and opalescent.
Danish: Kontroller at koncentratet er farveløst til lysebrunt og opaliserende.
English: The median time to onset of response in the infliximab-treated group was 2 weeks.
Danish: Mediantiden, til der registreredes en effekt i gruppen behandlet med infliximab, var 2 uger.
English: • Talk to you 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 fornylig har fået, eller det er planlagt, at du skal have behandling med et terapeutisk smitstof (fx instillation af BCG til behandling af kræft).
English: In study 6 and study 7, infliximab improved quality of life, confirmed by statistically significant improvement in both a disease specific measure, IBDQ, and by improvement in the generic 36-item short form survey SF-36.
Danish: Infliximab forbedrede livskvaliteten i studie 6 og studie 7, hvilket bekræftedes ved statistisk signifikant forbedring i både et sygdomsspecifikt mål, IBDQ, og ved forbedring i den almindelige 36-punkt korte udgave af spørgeskema SF-36.
English: Change from baseline in total van der Heijde-modified Sharp scoreb Mean ± SDa
Danish: Ændring fra baseline i total van der Heijde modificeret Sharp scoreb Gennemsnit ± SDa
English: Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, study 1
Danish: Tabel 3 Virkninger på ACR20, strukturel ledskade og fysisk funktionsevne ved uge 54, studie 1
English: Tuberculosis, fungal infections (e.g. candidiasis, onychomycosis ).
Danish: Tuberkulose, svampeinfektioner (fx candidiasis, onychomykose).
English: Caution should be exercised when considering the use of Zessly in patients with chronic infection or a history of recurrent infections, including concomitant immunosuppressive therapy.
Danish: Forsigtighed bør udvises, når brug af Zessly overvejes hos patienter med kronisk infektion eller med en sygdomshistorie med tilbagevendende infektioner, inklusive samtidig behandling med immunsuppressive lægemidler.