FrancophonIA/ELRC3.0 huggingface dataset:
English: In one of the study arms (group 2, n = 329), patients with an inadequate response were allowed to dose titrate with 1.5 mg/kg increments from 3 up to 9 mg/kg.
Danish: I en af armene (gruppe 2, n = 329) blev patienter med utilstrækkeligt respons tilladt dosisjustering med 1,5 mg/kg intervaller fra 3 op til 9 mg/kg.
English: Of patients who did not have an infusion reaction during the induction period, 9% experienced an infusion reaction during the maintenance period.
Danish: Af de patienter, som ikke fik en infusionsreaktion under induktionsfasen, fik 9 % en infusionsreaktion under vedligeholdelsesfasen.
English: Some patients who developed high titres of antibodies to infliximab had evidence of reduced efficacy.
Danish: Nogle patienter, der i høj grad udviklede antistoffer mod infliximab, havde tegn på nedsat effekt.
English: Week 54
Danish: Uge 54
English: Table 6 Percent of patients achieving corticosteroid-free clinical remission at week 26, SONIC
Danish: Tabel 6 Procent af patienter, som opnåede kortikosteroidfri klinisk remission i uge 26, SONIC AZA Monoterapi
English: There have also been post-marketing reports of new onset heart failure, including heart failure in patients without known pre-existing cardiovascular disease.
Danish: Der er også, ligeledes efter markedsføring, modtaget rapporter om nyopstået hjerteinsufficiens, inklusive hjerteinsufficiens hos patienter uden tidligere kendt hjerte-kar sygdom.
English: Placebo patients in the 2 Phase III studies in Crohn's disease, ACCENT I and ACCENT II, received an initial dose of 5 mg/kg infliximab at study start and were on placebo in the maintenance phase.
Danish: Placebo-patienter i de 2 fase III-studier med Crohns sygdom, ACCENT I og ACCENT II, fik som startdosis 5 mg/kg infliximab ved studiets begyndelse og var på placebo i vedligeholdelsesfasen.
English: Remicade is available in packs of 1, 2, 3, 4 or 5 vials.
Danish: Remicade findes i pakninger med 1, 2, 3, 4 eller 5 hætteglas.
English: Of these 108 patients, 27 were treated with the recommended dosage of infliximab 5 mg/kg.
Danish: Af disse 108 patienter blev 27 behandlet med den anbefalede dosis på 5 mg/kg infliximab.
English: In a Phase II study aimed at evaluating Remicade in CHF, higher incidence of mortality due to worsening of heart failure were seen in patients treated with Remicade, especially those treated with the higher dose of 10 mg/kg (i.e. twice the maximum approved dose).
Danish: I et fase II studie, der skulle vurdere Remicade ved CHF, sås højere forekomst af dødsfald på grund af forværret hjerteinsufficiens hos patienter behandlet med Remicade, især hos patienter behandlet med den højere dosis på 10 mg/kg (svarende til to gange den maksimale godkendte dosis).
English: Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
Danish: Anden anvendelse af terapeutiske smitstoffer såsom levende svækkede bakterier (fx instillation af BCG i blæren ved behandling af cancer) kan medføre kliniske infektioner herunder disseminerede infektioner.
English: Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
Danish: Placebo-patienter fik methotrexat, mens infliximab-patienter fik både infliximab og methotrexat.
English: Infections were reported in 31 (51.7%) of 60 treated patients in C0168T72 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 C0168T72, og 22 (36,7 %) krævede oral eller parenteral antimikrobiel behandling.
English: Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNF) inhibitors, ATC code: L04AB02.
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, tumor nekrose faktor alfa (TNF)-hæmmere, ATC-kode: L04AB02.
English: Thirty one of these patients were treated with infliximab 5 mg/kg.
Danish: Enogtredive af disse patienter blev behandlet med infliximab 5 mg/kg.
English: Elevations of aminotransferases were observed (ALT more common than AST) in a greater proportion of patients receiving Remicade than in controls, both when Remicade was given as monotherapy and when it was used in combination with other immunosuppressive agents.
Danish: Stigninger i aminotransferaser blev set (ALAT mere almindeligt end ASAT) i en større del af patienter, der fik Remicade, end hos kontrolpersoner, både når Remicade blev givet i monoterapi, og når det blev brugt i kombination med andre immunsuppressive stoffer.
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 (tumor nekrose faktor) alfa.
English: The combination of Remicade with other biological therapeutics used to treat the same conditions as Remicade, including anakinra and abatacept, is not recommended (see section 4.4).
Danish: Kombination af Remicade og andre biologiske lægemidler anvendt til behandling af de samme lidelser som Remicade, herunder anakinra og abatacept, kan ikke anbefales (se pkt.
English: Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for C-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; pværdi) 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 8 Effects on clinical response, clinical remission and mucosal healing at weeks 8 and 30.
Danish: Tabel 8 Effekt på klinisk respons, klinisk remission og slimhindeheling i uge 8 og 30.
English: Remicade is produced in packs of 1, 2, 3, 4 or 5 vials.
Danish: Remicade fremstilles i pakninger med 1, 2, 3, 4 eller 5 hætteglas.
English: Chemical and physical in use stability of the diluted solution has been demonstrated for up to 28 days at 2 °C to 8 °C and for an additional 24 hours at 25 °C after removal from refrigeration.
Danish: Den fortyndede infusionsvæskes kemiske og fysiske stabilitet efter anbrud er påvist i op til 28 dage ved 2°C til 8°C og i yderligere 24 timer ved 25°C efter udtagning fra køleskab.
English: Clinical response at week 8 was similar between those with or without concomitant immunomodulator use at baseline.
Danish: Klinisk respons i uge 8 var den samme hos dem, som fik immunmodulator og hos dem, som ikke fik immunmodulator ved baseline.
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: • Some women being treated for rheumatoid arthritis with Remicade have developed cervical cancer.
Danish: • Nogle kvinder, der er blevet behandlet for reumatoid arthritis med Remicade, har udviklet livmoderhalskræft.
English: Do not store any unused portion of the infusion solution for reuse.
Danish: Opbevar ikke rester af den ikke anvendte infusionsvæske til fornyet brug.
English: In the 3 mg/kg Remicade 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 Remicade 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: Decreases in parameters of peripheral activity characteristic of psoriatic arthritis (such as number of swollen joints, number of painful/tender joints, dactylitis and presence of enthesopathy) were seen in the infliximab-treated patients.
Danish: Reduktion i parametrene for perifere aktivitetskarakteristika på psoriasis arthritis (såsom antal hævede led, antal smertefulde/ømme led, dactylitis og tilstedeværelse af entesopati) sås hos infliximab-behandlede patienter.
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: Sustained response (clinical response at both week 8 and week 30)
Danish: Vedvarende respons (klinisk respons både i uge 8 og uge 30)
English: Cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis, have been observed in the post-marketing experience of Remicade.
Danish: Tilfælde af gulsot og ikke-infektiøs hepatitis, nogle med tegn på autoimmun hepatitis, er set efter markedsføring af Remicade.
English: Of the infliximab-treated patients who received at least one shortened infusion, infusion-related reactions occurred in 15% of patients and serious infusion reactions occurred in 0.4% of patients.
Danish: Hos de patienter, der blev behandlet med infliximab, og som fik mindst en kort infusion, opstod infusionsrelaterede reaktioner hos 15 % af patienterne, og alvorlige infusionsreaktioner opstod hos 0,4 % af patienterne.
English: In psoriatic arthritis patients who received 5 mg/kg with and without methotrexate, antibodies occurred overall in 15% of patients (antibodies occurred in 4% of patients receiving methotrexate and in 26% of patients not receiving methotrexate at baseline).
Danish: Hos patienter med psoriasis arthritis, der modtog 5 mg/kg med og uden methotrexat, forekom der i alt antistoffer hos 15 % af patienterne (der forekom antistoffer hos 4 % af de patienter, der fik methotrexat og hos 26 % af de patienter, der ikke fik methotrexat ved baseline).
English: In most patients, infliximab could be detected in the serum for at least 8 weeks after the recommended single dose of 5 mg/kg for Crohn's disease and the rheumatoid arthritis maintenance dose of 3 mg/kg every 8 weeks.
Danish: Hos de fleste patienter kunne infliximab påvises i serum i mindst 8 uger efter den anbefalede enkeltdosis på 5 mg/kg til Crohns sygdom og reumatoid arthritis vedligeholdelsesdosis på 3 mg/kg hver 8. uge.
English: • In case you have received Remicade 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 Remicade, mens du var gravid, er det vigtigt, at du informerer dit barns læge om det, før dit barn bliver vaccineret.
English: • Serious lung problems (such as interstitial lung disease)
Danish: • Alvorlige lungeproblemer (såsom interstitiel lungesygdom)
English: This patient reminder card contains important safety information that you need to be aware of before and during treatment with Remicade.
Danish: Dette patientinformationskort indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under behandling med Remicade.
English: Caution should also be exercised in patients with psoriasis and a medical history of extensive immunosuppressant therapy or prolonged PUVA treatment.
Danish: Forsigtighed bør også udvises hos patienter med psoriasis og tidligere ekstensiv immunsupprimerende behandling eller forlænget PUVA behandling.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Remicade and is positive for antibodies against double-stranded DNA, further treatment with Remicade 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 Remicade og er positiv over for antistoffer mod dobbeltstrenget DNA, må behandling med Remicade ikke fortsættes (se pkt.
English: > 54 weeks
Danish: > 54 uger
English: Discontinuation of immunomodulators and corticosteroid taper were permitted after week 0.
Danish: Seponering af immunmodulatorer og nedtrapning af kortikosteroid-dosis var tilladt efter uge 0.
English: N/A 6.7% N/A 1.7%
Danish: N/A 49,4 N/A 6,7 % N/A 1,7 %
English: Unchanged infliximab was not detected in urine.
Danish: Uomdannet infliximab blev ikke påvist i urin.
English: At baseline 53% of patients were receiving immunomodulator therapy (6-MP, AZA and/or MTX) and 62% of patients were receiving corticosteroids.
Danish: Ved baseline fik 53 % af patienterne immunmodulerende behandling (6-MP, AZA og/eller MTX), og 62 % af patienterne fik kortikosteroider.
English: Patients may be pre-treated with e.g., an antihistamine, hydrocortisone and/or paracetamol to prevent mild and transient effects.
Danish: Patienter kan forbehandles med for eksempel et antihistamin, hydrokortison og/eller paracetamol, for at forebygge lette og forbigående reaktioner.
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 (TB), eller hvis du har været i tæt kontakt med en person, som har haft TB.
English: While the proportion of patients with infections was also higher in the younger age group, for serious infections, the proportions were similar in the two age groups.
Danish: Andelen af patienter med infektioner var også større i den yngre aldersgruppe, men andelen af patienter med alvorlige infektioner var ens i de to aldersgrupper.
English: Name doctor:
Danish: Lægens navn:
English: Common: Depression, insomnia.
Danish: Almindelig: Depression, søvnløshed.
English: • Feeling forgetful, irritable, confused, nervous
Danish: • Glemsomhed, irritabilitet, forvirring, nervøsitet
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 under pkt.
English: The safety and efficacy of re-administration after a Remicade-free interval of more than 16 weeks has not been established.
Danish: Sikkerhed og effekt ved fornyet indgift efter en Remicade-fri periode på over 16 uger er ikke kendt.
English: Clinical experience shows that host defence against infection is compromised in some patients treated with infliximab.
Danish: Klinisk erfaring viser, at modtagerens forsvar mod infektion er nedsat hos nogle patienter behandlet med infliximab.
English: Studies have not been performed in patients with liver or renal disease.
Danish: Studier hos patienter med lever- eller nyresygdom er ikke blevet udført.
English: At the last observation at 12 weeks, 13/27 (48%) of infliximab-treated patients were still responding.
Danish: Ved den sidste observation efter 12 uger sås stadig effekt hos 13/27 (48 %) af patienterne behandlet med infliximab.
English: • Some children and teenage patients who have received TNF-blockers such as Remicade have developed cancers, including unusual types, which sometimes resulted in death.
Danish: • Nogle børn og unge, som har fået TNF-blokkere såsom Remicade, har udviklet kræft inklusive usædvanlige typer kræft, som i visse tilfælde har været dødelige.
English: Ask your doctor to record the type and date of last screening(s) for tuberculosis (TB) below: Test
Danish: Du skal bede din læge om at notere type og dato for seneste screening(er) for tuberkulose (TB) nedenfor:
English: • Collections of immune cells resulting from an inflammatory response (granulomatous lesions)
Danish: • Ansamling af immunceller som følge af et inflammatorisk respons (granulomatøse læsioner)
English: Change from baseline in total van der Heijde-modified Sharp score Mean ± SD
Danish: Ændring fra baseline i total van der Heijde modificeret Sharp score Gennemsnit ± SD
English: A patient who requires surgery while on Remicade should be closely monitored for infections, and appropriate actions should be taken.
Danish: En patient, som kræver operation under Remicadebehandling, bør følges nøje for infektioner, og passende forholdsregler bør tages.
English: Placebo (week 16)
Danish: Placebo (uge 16)
English: In the re-treatment arm, 4% (8/219) of patients experienced a serious infusion reaction versus < 1% (1/222) on maintenance therapy.
Danish: I genbehandlingsarmen fik 4 % (8/219) af patienterne en alvorlig infusionsrelateret reaktion sammenlignet med < 1 % (1/222) på vedligeholdelsesbehandling.
English: Almost all patients had received treatment with AZA or 6-MP concomitantly with or immediately prior to a TNF-blocker.
Danish: Næsten alle disse patienter havde fået behandling med AZA eller 6-MP samtidig med eller umiddelbart før TNF-blokerende behandling.
English: Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology.
Danish: Infliximab er et kimerisk monoklonalt human-murin IgG1-antistof fremstillet i murine hybridomaceller ved rekombinant DNA-teknologi.
English: All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course.
Danish: Alle patienter med colitis ulcerosa, som har forhøjet risiko for dysplasi eller colon cancer (for eksempel patienter med langvarig colitis ulcerosa eller primær sklerotisk cholangitis), eller som tidligere har haft dysplasi eller colon cancer, bør screenes for dysplasi med reglmæssige intervaller før behandling og under deres sygdomsforløb.
English: In patients treated with methotrexate alone, the incidence of serious infections was 5.2% in patients 65 years and older compared to 2.7% in patients under 65 (see section 4.4).
Danish: Hos patienter behandlet med methotrexat alene var hyppigheden af alvorlige infektioner 5,2 % hos patienter på 65 år og derover sammenlignet med 2,7 % hos patienter under 65 år (se pkt.
English: At 102 weeks there were 80 subjects still on infliximab treatment and among those, 71 (89%) were ASAS 20 responders.
Danish: I 102. uge var 80 patienter stadig på infliximab-behandling og blandt disse var 71 (89 %) ASAS 20 responders.
English: Infusion reactions and hypersensitivity
Danish: Infusionsreaktioner og overfølsomhed
English: • Inflamed liver caused by a problem with the immune system (autoimmune hepatitis)
Danish: • Betændelsestilstand i leveren forårsaget af et problem med immunsystemet (autoimmun hepatitis)
English: N/A 4.4% N/A 1.5%
Danish: N/A 53,0 N/A 4,4 % N/A 1,5 %
English: The proportion of patients with infections in C0168T72 was similar to that in the paediatric Crohn's disease study (REACH) but higher than the proportion in the adults ulcerative colitis studies (ACT 1 and ACT 2).
Danish: Andelen af patienter med infektioner i C0168T72 svarede til andelen i studiet med børn med Crohns sygdom (REACH), men var højere end andelen i studierne med voksne med colitis ulcerosa (ACT 1 og ACT 2).
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: Improvements in quality of life measures, a reduction in disease-related hospitalisations and corticosteroid use were seen in the infliximab maintenance groups compared with the placebo maintenance group at weeks 30 and 54.
Danish: Forbedring af målene for livskvalitet, reduktion i sygdomsrelateret hospitaliseringer og brug af kortikosteroid sås for infliximab-vedligeholdelsesgrupperne sammenlignet med placebovedligeholdelsesgruppen ved ugerne 30 og 54.
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: In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤ 35%) were treated with 3 infusions of Remicade 5 mg/kg, 10 mg/kg, or placebo over 6 weeks.
Danish: I dette studie blev 150 patienter med NYHA funktionsklasse III-IV CHF (venstre ventrikels uddrivningsfraktion ≤ 35 %) behandlet med 3 infusioner Remicade 5 mg/kg, 10 mg/kg eller placebo i løbet af 6 uger.
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: In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated (see section 5.1).
Danish: I disse patientpopulationer er en reduktion i hastigheden af progressionen af ledskade, målt ved røntgen, blevet påvist (se pkt.
English: Steroid-Free Remission
Danish: Steroidfri remission
English: Reduction in the rate of progression of structural damage was observed at weeks 30 and 54 in the infliximab + methotrexate groups compared to methotrexate alone.
Danish: Reduktionen i progressionshastigheden af strukturel skade blev observeret ved ugerne 30 og 54 i infliximab + methotrexat grupperne sammenlignet med methotrexat alene.
English: Storage beyond 24 hours at 2 °C - 8 °C applies to preparation of Remicade in the infusion bag only.
Danish: Opbevaring i mere end 24 timer ved 2 °C - 8 °C gælder udelukkende for klargøring af Remicade i infusionsposen.
English: In the Phase IIIb trial in Crohn's disease, SONIC, 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, SONIC, fik placebo-patienterne AZA 2,5 mg/kg/dag som aktiv kontrol i tillæg til placebo-infliximab-infusioner.
English: Following administration of 5 mg/kg Remicade every 8 weeks, the predicted median steady-state infliximab exposure (area under concentration-time 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 Remicade 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 median steady-state lægemiddel-eksponering hos voksne.
English: • It is important that you tell your baby's doctors and other healthcare professionals about your Remicade 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 Remicade, før barnet bliver vaccineret.