FrancophonIA/ELRC3.0 huggingface dataset:
English: Signs include yellowing of the skin and eyes, dark-brown coloured urine, pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever.
Danish: Tegn omfatter gulfarvning af hud og øjne, mørkebrun urin, smerter eller hævelse i øvre højre side af maven, ledsmerter, hududslæt eller feber.
English: p < 0.001, for each infliximab treatment group vs. placebo.
Danish: p < 0,001, for hver infliximab-behandlingsgruppe mod placebo.
English: Remicade is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Danish: Remicade er indiceret til behandling af svær, aktiv ankyloserende spondylitis hos voksne patienter, som har responderet utilstrækkeligt på konventionel behandling.
English: Before treatment with Remicade
Danish: Før behandling med Remicade
English: Maintenance treatment in fistulising active Crohn's disease The efficacy of repeated infusions with infliximab in patients with fistulising Crohn's disease was studied in a 1-year clinical study (ACCENT II).
Danish: Vedligeholdelsesbehandling af fistulerende, aktiv Crohns sygdom Effekten af gentagne infusioner med infliximab hos patienter med fistulerende Crohns sygdom blev undersøgt i et 1-års klinisk studie (ACCENT II).
English: In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNF, there was no indication of maternal toxicity, embryotoxicity or teratogenicity (see section 5.3).
Danish: I et toksicitetsstudie vedrørende udvikling udført på mus med et analogt antistof, som selektivt hæmmer den funktionelle aktivitet af muse-TNF, var der ingen tegn på maternal toksicitet, embryotoksicitet eller teratogenicitet (se pkt.
English: Sixty eight percent (21/31) of infliximab-treated patients receiving a 5 mg/kg dose regimen achieved a clinical response vs. 26% (8/31) placebo-treated patients (p = 0.002).
Danish: Otteogtres procent (21/31)af patienter behandlet med infliximab, der fik et 5 mg/kg doseringsregimen, opnåede en klinisk effekt mod 26 % (8/31) af placebobehandlede patienter (p = 0,002).
English: • Infections due to a weakened immune system
Danish: • Infektioner, som skyldes nedsat immunforsvar
English: • Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur followed by infusions of 5 mg/kg every 8 weeks (see ‘Re-administration' below and section 4.4).
Danish: • Fornyet indgift: Doser på 5 mg/kg, hvis sygdomstegn og symptomer på sygdommen kommer igen, efterfulgt af infusionsdoser på 5 mg/kg hver 8. uge (se "Fornyet indgift" nedenfor samt pkt.
English: • A rare blood cancer affecting mostly teenage boys or young men (hepatosplenic T-cell lymphoma)
Danish: • En sjælden blodkræft som hovedsageligt rammer teenagedrenge eller unge mænd
English: At week 24, the number of ASAS 20 responders was 15/78 (19%) in the placebo group, and 123/201 (61%) in the 5 mg/kg infliximab group (p < 0.001).
Danish: I uge 24 var antallet af ASAS 20 responders 15/78 (19 %) i placebogruppen og 123/201 (61 %) i gruppen, der fik 5 mg/kg infliximab (p < 0,001).
English: Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients treated with infliximab.
Danish: Tuberkulose, bakterieinfektioner, inklusive sepsis og pneumoni, invasive svampeinfektioner, virale infektioner og andre opportunistiske infektioner er set hos patienter behandlet med infliximab.
English: There have been post-marketing reports of worsening heart failure, with and without identifiable precipitating factors, in patients taking Remicade.
Danish: Efter markedsføring er der rapporteret tilfælde af forværret hjerteinsufficiens hos Remicade patienter, med eller uden identificerbare predisponerende faktorer.
English: At week 14, 282 patients were assessed for clinical response and randomised to receive either placebo or 5 mg/kg infliximab every 8 weeks through week 46.
Danish: Ved uge 14 blev 282 patienter bedømt til klinisk respons og randomiseret til at få enten placebo eller 5 mg/kg infliximab hver 8. uge til og med uge 46.
English: Uncommon: Vaginitis.
Danish: Ikke almindelig: Vaginitis.
English: PGA of cleared (0) or minimal (1) PGA of cleared (0), minimal (1), or mild (2) All nails cleared
Danish: PGA helt væk (0) eller minimale (1) PGA helt væk (0), minimale (1) eller lette (2) Alle negle fri for psoriasis Uge 10
English: The safety and efficacy of Remicade have not been studied in children with Crohn's disease below the age of 6 years.
Danish: Remicades sikkerhed og virkning hos børn under 6 år med Crohns sygdom er ikke klarlagt.
English: • Other skin problems such as erythema multiforme, lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes), blisters and peeling skin,
Danish: • Andre hudproblemer såsom erythema multiforme, lichenoide reaktioner (kløende, rødligt-lilla hududslæt og/eller trådlignende gråhvide linjer på slimhinderne), blærer og afskalning af huden eller bylder (furunkulose)
English: Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including Remicade (see section 4.8).
Danish: Der er rapporteret om melanom og Merkelcellekarcinom hos patienter, der har fået TNF-blokerende behandling, herunder Remicade (se pkt.
English: During treatment with Remicade
Danish: Under behandling med Remicade
English: ≥ 50% improvement
Danish: ≥ 50 % forbedring
English: • Shortage of blood supply, swelling of a vein
Danish: • Manglende blodtilførsel, hævelse af en blodåre
English: With the current knowledge, a risk for the development of lymphomas or other malignancies in patients treated with a TNF-blocking agent cannot be excluded (see section 4.8).
Danish: Med den nuværende viden kan en mulig risiko for udvikling af lymfomer eller andre maligne sygdomme hos patienter behandlet med et TNF-blokerende middel ikke udelukkes (se pkt.
English: In the first study (P01522), which had a 3 month double-blind phase, 70 patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6 (35 patients in each group).
Danish: I det første studie (P01522), som havde en dobbelblind fase på 3 måneder, modtog 70 patienter enten 5 mg/kg infliximab eller placebo i uge 0, 2, 6 (35 patienter i hver gruppe).
English: For more information see section on Pregnancy and breast-feeding.
Danish: Se afsnittet om Graviditet, amning og frugtbarhed for yderligere information.
English: Infliximab Maintenance 5 mg/kg (n = 113) (p value)
Danish: Infliximabvedligeholdelse 5 mg/kg (n = 113) (p-værdi)
English: In clinical studies, infections have been reported in a higher proportion of paediatric patients compared to adult patients (see section 4.8).
Danish: I kliniske studier er infektioner rapporteret hyppigere hos pædiatriske patienter end hos voksne patienter (se pkt.
English: At week 12, placebo patients were switched to infliximab 5 mg/kg every 6 weeks up to week 54.
Danish: I uge 12 blev placebopatienter skiftet over til infliximab 5 mg/kg hver 6. uge indtil uge 54.
English: 5.7% [95% CI 2.65%-10.6%].
Danish: Median opfølgningsperioden var 0,8 år (incidens 5,7 % [95 % CI 2,65 %-10,6 %].
English: Moderately to severely active Crohn's disease
Danish: Moderat til svært aktiv Crohns sygdom
English: Patient Reminder Card
Danish: Patientinformationskort
English: Signs and symptoms included myalgia and/or arthralgia with fever and/or rash, with some patients experiencing pruritus, facial, hand or lip oedema, dysphagia, urticaria, sore throat and headache.
Danish: Tegn og symptomer inkluderede myalgi og/eller artralgi med feber og/eller udslæt, og nogle patienter oplevede kløe, ansigts-, hånd eller læbeødem, dysfagi, urticaria, ondt i halsen og hovedpine.
English: A total of 306 patients received 3 doses of infliximab 5 mg/kg at week 0, 2 and 6.
Danish: I alt 306 patienter fik 3 doser infliximab på 5 mg/kg i ugerne 0, 2 og 6.
English: Infliximab Maintenance 10 mg/kg (n = 112) (p value)
Danish: Infliximabvedligeholdelse 10 mg/kg (n = 112) (p-værdi)
English: • Skin problems such as blistering, warts, abnormal skin colouration or pigmentation, or swollen lips, or thickening of the skin, or red, scaly, and flaky skin
Danish: • Hudproblemer såsom blæredannelse, vorter, unormal hudfarve eller pigmentering, eller hævede læber, eller fortykkelse af huden eller rød, skællende hud og afskalning af huden
English: Some cases of active tuberculosis have been reported in patients treated with Remicade during and after treatment for latent tuberculosis.
Danish: Der er rapporteret om enkelte tilfælde af aktiv tuberkulose under og efter behandling for latent tuberkulose hos patienter i behandling med Remicade.
English: Remicade is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and
Danish: Remicade er indiceret til behandling af moderat til svær, aktiv colitis ulcerosa hos voksne patienter, som har haft utilstrækkelig respons af konventionel behandling inklusive kortikosteroider og 6
English: Common: Hepatic function abnormal, transaminases increased.
Danish: Almindelig: Unormal leverfunktion, forhøjede leveraminotransferaser.
English: The most commonly reported infections were upper respiratory tract infection and pharyngitis, and the most commonly reported serious infection was abscess.
Danish: De mest almindeligt rapporterede infektioner var øvre luftvejsinfektioner og pharyngitis.
English: Patients assessed by the investigator to be in clinical response at week 10 were randomised and received 5 mg/kg infliximab at either q8 weeks or q12 weeks as a maintenance treatment regimen.
Danish: De patienter, som af investigator blev vurderet til at have et klinisk respons i uge 10, blev randomiseret og fik 5 mg/kg infliximab enten hver 8. eller hver 12. uge som et vedligeholdelsesbehandlingsregime.
English: If you have active rheumatoid arthritis you will first be given other medicines.
Danish: Hvis du har aktiv reumatoid arthritis, vil du først få andre lægemidler.
English: Discontinuation of Remicade therapy should be considered in patients with confirmed significant haematologic abnormalities.
Danish: Seponering af Remicadebehandling bør overvejes hos patienter, hvor signifikante blodanormaliteter er bekræftet.
English: The following adverse reactions were reported more commonly in paediatric Crohn's disease patients in the REACH study (see section 5.1) than in adult Crohn's disease patients: anaemia (10.7%), blood in stool (9.7%), leucopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%).
Danish: 5.1): anæmi (10,7 %), blod i afføringen (9,7 %), leukopeni (8,7 %), rødmen (8,7 %), viral infektion (7,8 %), neutropeni (6,8 %), bakteriel infektion (5,8 %) og allergisk reaktion i luftvejene (5,8 %).
English: • Side effect due to an infusion
Danish: • Bivirkninger i forbindelse med infusionen
English: Heijde-modified Sharp score) Change from baseline (Mean ± SD
Danish: Total score d (van der Heijdemodified Sharp score) Ændring fra baseline (Gennemsnit  SD
English: The proportions of patients with mucosal healing at week 26 were significantly greater in the infliximab plus AZA combination (43.9%, p < 0.001) and infliximab monotherapy groups (30.1%, p = 0.023) compared to the AZA monotherapy group (16.5%).
Danish: Andelen af patienter med slimhindeheling i uge 26 var signifikant større i grupperne, der fik infliximab plus AZA (43,9 %; p < 0,001) eller infliximab-monoterapi (30,1 %; p = 0,023) sammenlignet med AZA-monoterapigruppen (16,5 %).
English: Patients received three doses of either placebo or infliximab at weeks 0, 2 and 6.
Danish: Patienterne modtog tre doser af enten placebo eller infliximab i uge 0, 2 og 6.
English: • The other ingredients are sucrose, polysorbate 80, monobasic sodium phosphate and dibasic sodium phosphate.
Danish: • Øvrige indholdsstoffer: saccharose, polysorbat 80, natriumdihydrogenphosphat og dinatriumphosphatdihydrat.
English: Remicade is indicated for treatment of severely active ulcerative colitis, in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Danish: Remicade er indiceret til behandling af svær, aktiv colitis ulcerosa hos børn og unge i alderen 6 til 17 år, som har responderet utilstrækkeligt på konventionel behandling, inklusive kortikosteroider og 6-MP eller AZA, eller som er intolerante over for eller hvor der er kontraindikationer mod disse behandlinger.
English: Signs include fever, cough, flu-like signs, feeling unwell, red or hot skin, wounds or dental problems.
Danish: Tegn inkluderer feber, hoste, influenzalignende symptomer, utilpashed, rød eller ophedet hud, sår eller problemer med tænderne.
English: Post-marketing spontaneous serious adverse reactions with infliximab in the paediatric population have included malignancies including hepatosplenic T-cell lymphomas, transient hepatic enzyme abnormalities, lupus-like syndromes, and positive auto-antibodies (see sections 4.4 and 4.8).
Danish: Spontane alvorlige bivirkninger hos børn efter markedsføring af infliximab inkluderer malignititer inklusive hepatosplenisk T-celle-lymfom, forbigående leverenzymabnormaliteter, lupus lignende syndromer og positive autoantistoffer (se pkt.
English: Remicade and Orencia should not be used together.
Danish: Du må ikke få Remicade og Orencia samtidig.
English: • Bleeding in the stomach or intestines, diarrhoea, indigestion, heartburn, constipation
Danish: • Blødning i mave eller tarme, diarré, fordøjelsesbesvær, halsbrand, forstoppelse
English: Uncommon: Thrombocytopenia, lymphopenia, lymphocytosis.
Danish: Ikke almindelig: Trombocytopeni, lymfopeni, lymfocytose.
English: Common: Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation.
Danish: Almindelig: Gastrointestinal blødning, diarré, dyspepsi, gastroøsofageal refluks, forstoppelse.
English: Upper respiratory tract infection was the most common adverse drug reaction (ADR) reported in clinical trials, occurring in 25.3% of infliximab-treated patients compared with 16.5% of control patients.
Danish: Den almindeligste bivirkning rapporteret i kliniske studier var øvre luftvejsinfektion, der forekom hos 25,3 % af de infliximab-behandlede patienter sammenlignet med hos 16,5 % af kontrolpatienterne.
English: • Feeling tired or weak
Danish: • Trætheds- eller svaghedsfølelse
English: Remicade is indicated for treatment of severe, active Crohn's disease, in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.
Danish: Remicade er indiceret til behandling af svær, aktiv Crohns sygdom hos børn og unge mellem 6 og 17 år, som ikke har responderet på konventionel behandling inklusive kortikosteroid, immunmodulator og primær ernæringsbehandling, eller som er intolerante over for eller hvor der er kontraindikationer mod sådanne behandlinger.
English: Uncommon: Bullous eruption, seborrhoea, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation.
Danish: Ikke almindelig: Bulløst udslæt, seborre, rosacea, hudpapilom, hyperkeratose, unormal hudpigmentering.
English: Had treatment with Remicade before
Danish: Været i behandling med Remicade tidligere
English: The number of ulcerative colitis-related hospitalisations was significantly lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of hospitalisations per 100 subject-years: 21 and 19 vs. 40 in the placebo group; p = 0.019 and p = 0.007, respectively).
Danish: Antallet af hospitalsindlæggelser relateret til colitis ulcerosa var signifikant lavere i 5 og 10 mg/kg infliximab-behandlingsgrupperne end i placebogruppen (gennemsnitligt antal hospitalsindlæggelser per 100 forsøgsperson-år: 21 og 19 versus 40 i placebogruppen; hhv. p = 0,019 og p = 0,007).
English: • Inflamed lining of the lung, causing sharp chest pains that feel worse with breathing (pleurisy)
Danish: • Lungehindebetændelse, der giver skape smerter, som forværres ved vejrtrækning (pleuritis)
English: The vast majority of Remicade cases have occurred in patients with Crohn's disease or ulcerative colitis and most were reported in adolescent or young adult males.
Danish: Hos patienter, som fik Remicade, er langt de fleste tilfælde forekommet hos patienter med Crohns sygdom eller colitis ulcerosa og de fleste blev rapporteret hos unge eller unge voksne mænd.
English: Clinical response at week 30
Danish: Klinisk respons i uge 30
English: Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.
Danish: Fortsat behandling bør revurderes nøje hos patienter, som ikke viser tegn på terapeutisk effekt inden for denne periode.
English: • Severe allergic reactions (e.g. anaphylaxis), an immune system disorder called lupus, allergic reactions to foreign proteins
Danish: • Alvorlige allergiske reaktioner (fx anafylaksi), en sygdom i immunsystemet kaldet lupus,
English: Concurrent administration of TNF-alpha inhibitor 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 compared to etanercept alone.
Danish: Der blev observeret alvorlige infektioner og neutropeni i kliniske studier ved samtidig anvendelse af anakinra og et andet TNFα-blokerende middel, etanercept, uden nogen øget klinisk fordel sammenlignet med etanercept indgivet alene.
English: PGA of cleared (0), minimal (1), or mild (2)
Danish: PGA helt væk (0), minimale (1) eller lette (2)
English: Common: New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia.
Danish: Hud og subkutane væv Almindelig: Debuterende eller forværring af allerede eksisterende psoriasis, inklusive pustuløs psoriasis (primært palmoplantaris), urticaria, udslæt, pruritus, øget svedtendens, tør hud, svampedermatitis, eksem, alopeci.
English: Uncommon: Pulmonary oedema, bronchospasm, pleurisy, pleural effusion.
Danish: Ikke almindelig: Lungeødem, bronkospasme, pleuritis, pleural effusion.
English: • Signs of an immune system disorder such as joint pain or a rash on cheeks or arms that is sensitive to the sun (lupus) or cough, shortness of breath, fever or skin rash (sarcoidosis).
Danish: • Tegn på en sygdom i immunsystemet såsom ledsmerter, udslæt på kinder eller arme, som er følsomme over for solen (lupus) eller hoste, åndenød, feber eller hududslæt (sarkoidose).
English: Not known: Transient visual loss occurring during or within 2 hours of infusion.
Danish: Ikke kendt: Kortvarigt synstab under infusionen eller inden for 2 timer efter infusionen.
English: There have been reports of pancytopenia, leucopenia, neutropenia, and thrombocytopenia in patients receiving TNF-blockers, including Remicade.
Danish: Der er set pancytopeni, leukopeni, neutropeni og trombocytopeni hos patienter, der fik TNFhæmmere, herunder Remicade.
English: Concurrent administration of TNF-alpha inhibitor 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 anvendelse af TNF-alfahæmmere 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-hæmmere alene.
English: The number of ulcerative colitis-related surgical procedures was also lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of surgical procedures per 100 subject-years: 22 and 19 vs. 34; p = 0.145 and p = 0.022, respectively).
Danish: Antallet af kirurgiske indgreb relateret til colitis ulcerosa var også lavere i 5 og 10 mg/kg infliximab-behandlingsgrupperne end i placebogruppen (gennemsnitligt antal kirurgiske indgreb per 100 forsøgsperson-år: 22 og 19 versus 34; hhv. p = 0,145 og p = 0,022).
English: Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Remicade.
Danish: Fortæl straks din læge, hvis du får nye eller forværrede tegn på hjertesvigt under behandlingen med Remicade.
English: A population-based retrospective cohort study found an increased incidence of cervical cancer in women with rheumatoid arthritis treated with infliximab compared to biologics-naïve patients or the general population, including those over 60 years of age (see section 4.4).
Danish: I et populationsbaseret, retrospektivt kohortestudie sås en øget incidens af livmoderhalskræft hos kvinder med reumatoid artrit, som var blevet behandlet med infliximab, sammenlignet med patienter, der var naive i forhold til biologiske lægemidler, eller befolkningen generelt, inklusive kvinder over 60 år (se pkt.
English: p < 0.001, for each infliximab treatment group vs. control.
Danish: p < 0,001, for hver infliximab-behandlingsgruppe mod kontrol.
English: Rare: Circulatory failure, petechia, vasospasm.
Danish: Sjælden: Kredsløbssvigt, petekkier, vasospasme.
English: At week 4, following administration of a single dose, 22/27 (81%) of infliximab-treated patients receiving a 5 mg/kg dose achieved a clinical response vs. 4/25 (16%) of the placebo-treated patients (p < 0.001).
Danish: I uge 4 efter indgivelse af en enkelt dosis opnåede 22/27 (81 %) af de infliximab-behandlede patienter, der fik 5 mg/kg dosen en klinisk effekt mod 4/25 (16 %) af placebopatienterne (p < 0,001).
English: Clinical remission and mucosal healing occurred in a greater proportion of patients in the combined infliximab treatment group compared to the placebo treatment group at week 54 (34.6% vs. 16.5%, p < 0.001 and 46.1% vs. 18.2%, p < 0.001, respectively).
Danish: Klinisk remission og slimhindeheling forekom i en større andel af patienterne i den kombinerede infliximab behandlingsgruppe sammenlignet med placebobehandlingsgruppen i uge 54 (henholdsvis 34,6 % mod16,5 %, p < 0,001 og 46,1 % mod 18,2 %, p < 0,001).
English: Re-administration for psoriasis
Danish: Fornyet indgift ved psoriasis
English: Fistulising, active Crohn's disease
Danish: Fistulerende, aktiv Crohns sygdom
English: The proportions of patients in sustained response and sustained remission at week 54 were greater in the combined infliximab treatment group than in the placebo treatment group (37.9% vs. 14.0%, p < 0.001; and 20.2% vs. 6.6%, p < 0.001, respectively).
Danish: Andelene af patienter i vedvarende respons og vedvarende remission i uge 54 var større i den kombinerede infliximab-behandlingsgruppe end i placebobehandlingsgruppen (henholdsvis 37,9 % mod 14,0 %, p < 0,001 og 20,2 % mod 6,6 %, p < 0,001).
English: Emergency equipment, such as adrenaline, antihistamines, corticosteroids and an artificial airway must be available.
Danish: Nødudstyr såsom adrenalin, antihistaminer, kortikosteroider, tungeholder og Rubens ballon skal være tilgængeligt.
English: It is recommended that paediatric patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Remicade therapy.
Danish: Det anbefales, at pædiatriske patienter bliver vaccineret i overensstemmelse med gældende vaccinationsvejledninger, før Remicadebehandling påbegyndes, hvis dette er muligt.
English: Common: Chest pain, fatigue, fever, injection site reaction, chills, oedema.
Danish: Almindelig: Brystsmerte, træthed, feber, reaktioner på injektionsstedet, kulderystelser, ødem.
English: Remicade 100 mg powder for concentrate infliximab
Danish: Remicade 100 mg pulver til koncentrat infliximab i.v.