FrancophonIA/ELRC3.0 huggingface dataset:
English: Induction treatment in moderately to severely active Crohn's disease The efficacy of a single dose treatment with infliximab was assessed in 108 patients with active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) in a randomised, double-blinded, placebo-controlled, dose-response study.
Danish: Induktionsbehandling af moderat til svært aktiv Crohns sygdom Effekten af en éndosis behandling med infliximab blev vurderet hos 108 patienter med aktiv Crohns sygdom (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) i et randomiseret, dobbeltblind, placebokontrolleret, dosis-virknings studie.
English: Additional side effects in children and adolescents Children who took Remicade for Crohn's disease showed some differences in side effects compared with adults who took Remicade for Crohn's disease.
Danish: De bivirkninger, som børn i behandling med Remicade mod Crohns sygdom fik, var forskellige fra de bivirkninger, som voksne i behandling med Remicade mod Crohns sygdom fik.
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.
Danish: I et toksicitetsstudie vedrørende udvikling udført på mus ved brug af et analogt antistof, der selektivt hæmmer den funktionelle aktivitet af muse TNF, var der ingen tegn på maternal toksicitet, embryotoksicitet eller teratogenicitet.
English: The most serious ADRs associated with the use of TNF blockers that have been reported for Remicade include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, paediatric malignancy, sarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn's disease), and serious infusion reactions (see section 4.4).
Danish: De alvorligste bivirkninger forbundet med brugen af TNF-blokkere, som er blevet rapporteret for Remicade, inkluderer HBV-reaktivering, CHF (kongestivt hjertesvigt), alvorlige infektioner (inklusive sepsis, opportunistiske infektioner og TB), serumsygdom (forsinkede overfølsomhedsreaktioner), hæmatologiske reaktioner, systemisk lupus erythematosus/lupus-lignende syndrom, demyeliniserende sygdomme, hepatobiliære bivirkninger, lymfomer, HSTCL, leukæmi, Merkelcellekarcinom, melanom, pædiatrisk malignitet, sarkoidose/sarkoid-lignende reaktion, byld i tarmen eller ved endetarmen (ved Crohns sygdom) og alvorlige infusionsreaktioner (se pkt.
English: Do not infuse Remicade concomitantly in the same intravenous line with other agents.
Danish: Infunder ikke Remicade i den samme intravenøse slange med andre midler.
English: Available data do not support further infliximab treatment, in patients not responding within 6 weeks of the initial infusion.
Danish: Eksisterende resultater støtter ikke fortsat infliximab-behandling hos patienter, der ikke responderer inden for 6 uger efter den første infusion.
English: In post-marketing surveillance, cases of jaundice and hepatitis, some with features of autoimmune hepatitis, have been reported in patients receiving Remicade (see section 4.4).
Danish: Under overvågning efter markedsføring er der rapporteret tilfælde af gulsot og hepatitis, nogle med tegn på autoimmun hepatitis, hos patienter, der fik Remicade (se pkt.
English: The efficacy of infliximab was assessed in two multicentre, randomised, double-blind, pivotal clinical studies: ATTRACT and ASPIRE.
Danish: Effekten af infliximab blev vurderet i to multicenter, randomiserede, dobbeltblinde, basale kliniske studier: ATTRACT og ASPIRE.
English: Available data do not support further infliximab treatment in children and adolescents not responding within the first 10 weeks of treatment (see section 5.1).
Danish: De tilgængelige data understøtter ikke yderligere infliximab-behandling af børn og unge, som ikke responderer inden for de første 10 ugers behandling (se pkt.
English: Caution should be exercised when considering TNF-blocking therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy.
Danish: Når TNF-blokerende behandling overvejes bør forsigtighed udvises hos patienter med en fortid med maligne sygdomme, eller når fortsat behandling overvejes hos patienter, der udvikler maligne sygdomme.
English: Anti-dsDNA antibodies were newly detected in approximately 17% of infliximab-treated patients compared with 0% of placebo-treated patients.
Danish: Anti-dsDNA antistoffer blev påvist første gang hos cirka 17 % af infliximab-behandlede patienter sammenlignet med 0 % af placebobehandlede patienter.
English: Crohn's disease is an inflammatory disease of the bowel.
Danish: Crohns sygdom er en betændelsessygdom i tarmen.
English: Maintenance treatment in moderately to severely active Crohn's disease in adults The efficacy of repeated infusions with infliximab was studied in a 1-year clinical study (ACCENT I).
Danish: Vedligeholdelsesbehandling af moderat til svært aktiv Crohns sygdom hos voksne Effekten af gentagne infusioner med infliximab blev undersøgt i et 1-års klinisk studie (ACCENT I).
English: • Signs of serious skin problems such as reddish-target-like spots or circular patches often with central blisters on the trunk, large areas of peeling and shedding (exfoliating) skin, ulcers of mouth, throat, nose, genitals and eyes or small pus-filled bumps that can spread over the body.
Danish: • Tegn på alvorlige hudproblemer såsom rødlige, målskivelignende pletter eller runde områder ofte med blærer centralt på kroppen, store områder med afskalning (eksfoliation) samt sår i mund, svælg, næse, kønsorganer og øjne eller små pusholdige blærer, som kan sprede sig over hele kroppen.
English: At week 30, the proportion of subjects in clinical remission was higher in the q8 week (59.6%, 31/52) than the q12 week maintenance treatment group (35.3%, 18/51; p = 0.013).
Danish: I uge 30 var andelen af personer med klinisk remission højere i 8-ugers gruppen (59,6 %; 31/52) end i 12-ugers gruppen (35,3 %, 18/51; p = 0,013).
English: • Balance problems or feeling dizzy
Danish: • Balanceproblemer eller svimmelhed
English: In rheumatoid arthritis clinical studies, the incidence of serious infections including pneumonia was higher in infliximab plus methotrexate-treated patients compared with methotrexate alone especially at doses of 6 mg/kg or greater (see section 4.4).
Danish: I reumatoid arthritis kliniske studier var forekomsten af alvorlige infektioner inklusive pneumoni højere hos patienter behandlet med infliximab og methotrexat sammenlignet med methotrexat alene, specielt ved doser på 6 mg/kg eller derover (se pkt.
English: • Tell your doctor before you are given Remicade if you have an infection even if it is a very minor one.
Danish: • Fortæl din læge, før du får Remicade, hvis du har en infektion, også selvom det er en meget let infektion.
English: Patients received 3 or 6 mg/kg infliximab as a 3-dose induction regimen (weeks 0, 2, 6 or weeks 14, 16, 20 respectively) followed by maintenance therapy every 8 weeks, in combination with methotrexate.
Danish: Patienterne fik 3 eller 6 mg/kg infliximab som et 3 dose induktionsregi (hhv. uge 0, 2, 6 eller uge 14, 16, 20) fulgt af vedligeholdelsesbehandling hver 8. uge i kombination med methotrexat.
English: Tumour necrosis factor alpha (TNF) mediates inflammation and modulates cellular immune responses.
Danish: Tumor nekrose faktor alfa (TNF) frembringer betændelse og modulerer cellulært immunrespons.
English: • A hole in the bowel or blockage of the intestine, stomach pain or cramps
Danish: • Hul i tarmen eller blokering af tarmen, mavesmerter eller -kramper
English: Eighty nine percent (50/56) of patients who lost clinical response on infliximab 5 mg/kg maintenance therapy after week 14 responded to treatment with infliximab 10 mg/kg.
Danish: Niogfirs procent (50/56) af patienterne, der mistede klinisk respons på infliximab 5 mg/kg vedligeholdelsesbehandling efter uge 14, responderede på behandling med infliximab 10 mg/kg.
English: • Stomach pain, feeling sick
Danish: • Mavesmerter, kvalme
English: Rheumatoid arthritis is an inflammatory disease of the joints.
Danish: Reumatoid arthritis er en betændelsessygdom i leddene.
English: Infliximab Maintenance (5 mg/kg) (n = 96)
Danish: Infliximab Vedligeholdelse (5 mg/kg) (n = 96)
English: If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Remicade.
Danish: Hvis du er i tvivl, om noget af ovenstående passer på dig, skal du tale med din læge eller apotekspersonalet, før du får Remicade.
English: Uncommon: Hepatitis, hepatocellular damage, cholecystitis.
Danish: Ikke almindelig: Hepatitis, hepatocellulær skade, kolecystitis.
English: • Lung or chest infections such as bronchitis or pneumonia
Danish: • Infektioner i lunger eller luftveje såsom bronkitis eller lungebetændelse
English: Immunogenicity Antibodies to infliximab were detected in 3 (2.9%) paediatric patients.
Danish: Immunogenicitet Der blev påvist antistoffer overfor infliximab hos 3 (2,9 %) af børnene.
English: • You should receive recommended vaccinations before starting Remicade treatment.
Danish: • Du skal have de anbefalede vaccinationer, før du starter behandling med Remicade.
English: ≥ 75% improvement
Danish: ≥ 75 % forbedring
English: Dilute the total volume of the reconstituted Remicade solution dose to 250 ml with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: Fortynd den samlede dosis (volumen) af det rekonstituerede Remicade-koncentrat til 250 ml med natriumchlorid 9 mg/ml (0,9 %) infusionsvæske.
English: The safety and efficacy of infliximab were assessed in a multicenter, randomised, open-label, parallel-group clinical study (C0168T72) in 60 paediatric patients aged 6 through 17 years (median age 14.5 years) with moderately to severely active ulcerative colitis (Mayo score of 6 to 12; endoscopic subscore ≥ 2) with an inadequate response to conventional therapies.
Danish: Infliximabs sikkerhed og virkning blev vurderet i et multicenter, randomiseret, open-label, parallelgruppe klinisk studie (C0168T72) hos 60 pædiatriske patienter i alderen 6 til 17 år (medianalder 14,5 år) med moderat til svær aktiv colitis ulcerosa (Mayo-score på 6-12; endoskopisk subscore ≥ 2) med utilstrækkelig respons på konventionel behandling.
English: • Convulsions, nerve problems
Danish: • Kramper, nerveforstyrrelser
English: The primary endpoint was the proportion of patients who experienced a clinical response, defined as ≥ 50% reduction from baseline in the number of fistulae draining upon gentle compression on at least two consecutive visits (4 weeks apart), without an increase in the use of medicinal products or surgery for Crohn's disease.
Danish: Det primære endepunkt var andelen af patienter, der oplevede en klinisk effekt, bestemt som ≥ 50 % reduktion fra basislinien i antallet af fistler, drænet ved forsigtigt tryk, ved mindst to på hinanden følgende besøg (med 4 ugers mellemrum) uden øget brug af lægemidler eller kirurgisk indgreb for Crohns sygdom.
English: In the second clinical study (ASSERT), 279 patients were randomised to receive either placebo (Group 1, n = 78) or 5 mg/kg infliximab (Group 2, n = 201) at 0, 2 and 6 weeks and every 6 weeks to week 24.
Danish: I det andet kliniske studie (ASSERT) blev 279 patienter randomiseret til behandling med enten placebo (gruppe 1, n = 78) eller 5 mg/kg infliximab (gruppe 2, n = 201) i uge 0, 2 og 6 og derefter hver 6. uge indtil uge 24.
English: The safety and efficacy of Remicade were assessed in two (ACT 1 and ACT 2) randomised, double-blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6-MP, AZA)].
Danish: Sikkerhed og effekt ved Remicade blev vurderet i to (ACT 1 og ACT 2) randomiserede, dobbeltblinde, placebokontrollerede kliniske studier hos voksne patienter med moderat til svær, aktiv colitis ulcerosa (Mayo score 6 til 12; Endoskopi subscore ≥ 2) med et utilstrækkeligt respons på konventionel behandling [orale kortikosteroider, aminosalicylater og/eller immunmodulatorer (6-MP, AZA)].
English: The side effects that happened more in children were: low red blood cells (anaemia), blood in stool, low overall levels of white blood cells (leucopenia), redness or blushing (flushing), viral infections, low levels of white blood cells that fight infection (neutropenia), bone fracture, bacterial infection and allergic reactions of the breathing tract.
Danish: Følgende bivirkninger forekom hyppigere hos børn: nedsat antal røde blodlegemer (anæmi), blod i afføringen, nedsat samlet indhold af hvide blodlegemer (leukopeni), anfaldsvis ansigtsrødme, virusinfektioner, lavt indhold af hvide blodlegemer, der bekæmper infektion (neutropeni), knoglebrud, bakterieinfektion og allergiske reaktioner i luftvejene.
English: • Cervical cancer
Danish: • Livmoderhalskræft
English: • Low platelet count, too many white blood cells
Danish: • Lavt antal blodplader, for mange hvide blodlegemer
English: • Bruising, hot flush or nosebleed, warm, red skin (flushing)
Danish: • Blå mærker, hedeture eller næseblod, varm, rød hud (rødmen)
English: At least a six month waiting period following birth is recommended before the administration of live vaccines to infants exposed in utero to infliximab (see section 4.6).
Danish: Det tilrådes at vente mindst 6 måneder efter fødslen før administration af levende vacciner til spædbørn, der har været eksponeret for infliximab i uterus (se pkt.
English: The safety and efficacy of Remicade in children and adolescents younger than 18 years for the indication of juvenile rheumatoid arthritis have not been established.
Danish: Remicades sikkerhed og virkning hos børn og unge under 18 år for indikationen juvenil reumatoid arthritis er ikke klarlagt.
English: The safety and efficacy of Remicade in children and adolescents younger than 18 years for the indication of psoriasis have not been established.
Danish: Remicades sikkerhed og virkning hos børn og unge under 18 år for indikationen psoriasis er ikke klarlagt.
English: • Signs of a liver problem (including hepatitis B infection when you have had hepatitis B in the past) such as yellowing of the skin or 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 på leverproblemer (inklusive hepatitis B-infektion, hvis du tidligere har haft hepatitis B) såsom gulfarvning af hud eller øjne, mørkebrun urin, smerter eller hævelser i øvre højre side af maven, ledsmerter, hududslæt eller feber.
English: In the REACH study, infections were reported in 56.3% of randomised subjects treated with infliximab.
Danish: Der blev rapporteret infektioner hos 56,3 % af de randomiserede personer behandlet med infliximab i REACH studiet.
English: Remicade is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: Remicade fortyndes dog med natriumchlorid 9 mg/ml (0,9%) infusionsvæske, opløsning.
English: Gastrointestinal disorders Very common: Abdominal pain, nausea.
Danish: Mave-tarm-kanalen Meget almindelig: Abdominalsmerter, kvalme.
English: At week 54, the proportion of patients in clinical remission as measured by the PUCAI score was 38% (8/21) in the q8 week maintenance group and 18% (4/22) in the q12 week maintenance treatment group.
Danish: I uge 54 var andelen af patienter i klinisk remission målt ved PUCAI-scoren 38 % (8/21) i 8-ugers vedligholdelsesbehandlingsgruppen og 18 % (4/22) i 12-ugers vedligeholdelsesbehandlingsgruppen.
English: • treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Danish: • behandling af moderat til svært aktiv Crohns sygdom hos voksne patienter, som ikke har responderet på trods af en fuldstændig og adækvat behandling med et kortikosteroid og/eller et immunsuppressivum, eller som er intolerante over for eller har kliniske kontraindikationer for sådanne behandlinger.
English: Fewer subjects underwent colectomy in the 5 mg/kg infliximab group (28/242 or 11.6% [N.S.]) and the 10 mg/kg infliximab group (18/242 or 7.4% [p = 0.011]) than in the placebo group
Danish: Der var færre forsøgspersoner, som fik foretaget kolektomi i 5 mg/kg infliximabgruppen (28/242 eller 11,6 % [N.S.] og 10 mg/kg infliximab-gruppen (18/242 eller 7.4 % [p = 0,011]) end i placebogruppen (36/244;14,8 %).
English: Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment or after dose adjustment.
Danish: Fortsat behandling bør revurderes nøje hos patienter, som ikke viser tegn på klinisk effekt inden for de første 12 ugers behandling eller efter dosisjustering.
English: Week 30 Clinical Response
Danish: Uge 30 Klinisk respons
English: In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/pharyngeal oedema and severe bronchospasm, and seizure have been associated with Remicade administration (see section 4.4).
Danish: Efter markedsføring er hændelser af anafylaktisk lignende reaktioner, inklusive strube/spiserørs ødemer og alvorlige bronkospasmer, og kramper blevet forbundet med administrering af Remicade (se pkt.
English: Mean ± SD
Danish: Gennemsnit ± SD
English: If you are not sure if any of the above apply to you, talk to your doctor before you are given Remicade.
Danish: Hvis du er i tvivl, om noget af ovenstående passer på dig, skal du tale med din læge, før du får Remicade.
English: The effect of concomitant immunomodulator therapy was more profound in episodically-treated patients than in patients given maintenance therapy.
Danish: Effekten af samtidig behandling med immunmodulatorer var mere udtalt hos patienter behandlet periodevist i forhold til patienter i vedligeholdelsesbehandling.
English: • Signs of an allergic reaction such as swelling of your face, lips, mouth or throat which may cause difficulty in swallowing or breathing, skin rash, hives, swelling of the hands, feet or ankles.
Danish: • Tegn på en allergisk reaktion såsom hævelse af ansigt, læber, mund eller svælg, som kan forårsage besvær med at synke eller trække vejret, kløende udslæt, hævelse af hænder, fødder eller ankler.
English: PGA of cleared (0) or minimal (1)
Danish: PGA helt væk (0) eller minimale (1)
English: Available data do not support further infliximab treatment in paediatric patients not responding within the first 8 weeks of treatment (see section 5.1).
Danish: De tilgængelige data understøtter ikke yderligere infliximab-behandling hos pædiatriske patienter, som ikke responderer inden for de første 8 ugers behandling (se pkt.
English: Patients received 5 mg/kg infliximab- or placebo-infusions at weeks 0, 2 and 6 followed by maintenance therapy every 8 weeks through week 22 in the placebo group and through week 46 in the infliximab group.
Danish: Patienterne fik 5 mg/kg infliximab eller placebo infusioner i uge 0, 2 og 6 efterfulgt af vedligeholdelsesbehandling hver 8. uge indtil uge 22 i placebogruppen og indtil uge 46 i infliximab-gruppen.
English: If stored refrigerated after reconstitution and dilution, the infusion solution must be allowed to equilibrate at room temperature to 25 °C for 3 hours prior to Step 4 (infusion).
Danish: Hvis infusionsvæsken har været opbevaret i køleskab efter rekonstitution og fortynding, skal den have tid til at opnå stuetemperatur (25°C) i 3 timer forud for trin 4 (infusion).
English: • This medicine can also be stored in the original carton outside of refrigerated storage up to a maximum of 25 °C for a single period of up to six months, but not beyond the original expiry date.
Danish: • Lægemidlet kan også opbevares i den originale pakning uden for køleskab ved højst 25 °C i en enkelt periode på op til 6 måneder, men den oprindelige udløbsdato må ikke overskrides.
English: From a microbiological point of view, the infusion solution should be administered immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions.
Danish: Ud fra et mikrobiologisk synspunkt skal infusionsvæsken administreres straks, opbevaringstider og -forhold efter anbrud indtil anvendelse er brugerens ansvar, og de vil normalt ikke overskride 24 timer ved 2°C til 8°C, medmindre rekonstitution/fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
English: • Swelling of the liver (hepatitis) or gall bladder, liver damage
Danish: • Hævelse af lever (hepatitis) eller galdeblære, leverskade
English: Table 1 lists ADRs based on experience from clinical studies as well as adverse reactions, some with fatal outcome, reported from post-marketing experience.
Danish: Tabel 1 viser bivirkninger, som er set i kliniske studier, såvel som de bivirkninger, som er set efter markedsføring, heraf er nogle dødelige.
English: Live vaccines such as BCG should not be given to your baby within 6 months after birth.
Danish: Dit barn må ikke få levende vacciner som BCG indenfor 6 måneder efter fødslen.
English: Do not dilute the reconstituted Remicade solution with any other diluent.
Danish: Fortynd ikke det rekonstituerede Remicade-koncentrat med andre infusionsvæsker.
English: Starting at week 16, placebo patients were switched to infliximab and all patients subsequently received 5 mg/kg infliximab every 8 weeks up to week 46.
Danish: Startende i uge 16 blev placebobehandlede patienter skiftet til infliximab, og alle patienter fik herefter 5 mg/kg infliximab hver 8. uge frem til uge 46.
English: All patients received methotrexate (optimised to 20 mg/wk by week 8) and either placebo, 3 mg/kg or 6 mg/kg infliximab at weeks 0, 2, and 6 and every 8 weeks thereafter.
Danish: Alle patienter fik methotrexat (optimeret til 20 mg/uge ved uge 8) og enten placebo, 3 mg/kg eller 6 mg/kg infliximab i ugerne 0, 2 og 6 samt hver 8. uge derefter.
English: Ulcerative colitis (6 to 17 years)
Danish: Colitis ulcerosa (6-17 år)
English: In Phase III clinical studies, 18% of infliximab-treated patients compared with 5% of placebo-treated patients experienced an infusion-related reaction.
Danish: I fase III kliniske studier oplevede 18 % af de infliximab-behandlede patienter en infusionsrelateret reaktion sammenlignet med 5 % af de placebobehandlede patienter.
English: Infliximab was administered at a dose of 5 mg/kg at weeks 0, 2, 6, and then every 8 weeks.
Danish: Infliximab blev indgivet med en dosis på 5 mg/kg i ugerne 0, 2, 6 og derefter hver 8. uge.
English: Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients receiving Remicade.
Danish: Tuberkulose, bakterieinfektioner, inklusive sepsis og pneumoni, invasive svampeinfektioner, virale infektioner og andre opportunistiske infektioner har været observeret hos patienter, der fik Remicade.
English: A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p < 0.001, pooled ACT 1 & ACT 2 data) and week 54 (21.0% vs. 8.9%, p = 0.022, ACT1 data).
Danish: En større andel patienter i den kombinerede infliximab-behandlingsgruppe var i stand til at afbryde kortikosteroider og stadig blive i klinisk remission sammenlignet med placebobehandlingsgruppen i både uge 30 (22,3 % mod 7,2 %, p < 0,001, samlede ACT 1 & ACT 2 data) og uge 54 (21,0 % mod 8,9 %, p = 0,022, ACT 1 data).