FrancophonIA/ELRC3.0 huggingface dataset:
English: The majority (67%) of these patients did not require any dose titration.
Danish: Størstedelen af patienterne (67 %) behøvede ingen dosisjustering.
English: Keep this card with you for 4 months after your dose of Remicade, or in case of pregnancy for at least 6 months after the birth of your baby.
Danish: Opbevar dette kort på dig i 4 måneder, efter du har fået Remicade, eller i tilfælde af graviditet i mindst 6 måneder, efter du har født.
English: Infliximab-treated patients demonstrated significant improvement in physical function as assessed by HAQ.
Danish: Infliximab-behandlede patienter viste signifikant forbedring i fysisk funktionsevne, vurderet ved HAQ.
English: Avoid prolonged or vigorous agitation.
Danish: Undgå at svinge for længe eller for kraftigt.
English: Invasive fungal infections may present as disseminated rather than localised disease, and antigen and antibody testing may be negative in some patients with active infection.
Danish: Invasive svampeinfektioner kan være disseminerede snarere end lokale sygdomme, og test for tilstedeværelse af antigen og antistof kan være negativ hos nogle patienter med aktiv infektion.
English: Patients taking TNF-blockers are more susceptible to serious infections.
Danish: Patienter, som tager TNF-blokkere, er mere modtagelige for alvorlige infektioner.
English: Further treatment with Remicade must not be given if a patient develops a serious infection or sepsis.
Danish: Behandling med Remicade må ikke fortsættes, hvis en patient udvikler en alvorlig infektion eller sepsis.
English: Live vaccines/therapeutic infectious agents
Danish: Levende vacciner/terapeutiske smitstoffer
English: Not known: Cerebrovascular accidents in close temporal association with infusion.
Danish: Ikke kendt: Cerebrovaskulære hændelser i tæt tidsmæssig forbindelse med infusionen.
English: ** PASI 75 response for IMPACT not included due to low N; p < 0.001 for infliximab vs. placebo at week 24 for IMPACT 2.
Danish: ** PASI 75 respons for IMPACT ikke inkluderet som følge af lav N; p < 0.001 for infliximab vs. placebo i uge 24 for IMPACT 2.
English: Remicade should be administered
Danish: Remicade bør administreres
English: This should be taken into consideration for patients on a controlled sodium diet (see section 6.6).
Danish: Dette skal der tages hensyn til hos patienter på en kontrolleret natriumdiæt (se pkt.
English: START was a randomised, multicenter, double-blind, 3-arm, parallel-group safety study.
Danish: START var et randomiseret, multicenter, dobbelblindt, 3-armet, parallel- gruppe sikkerhedsstudie.
English: • Reduce the number of abnormal openings (fistulae) between your bowel and your skin that have not been controlled by other medicines or surgery.
Danish: • Sænke antallet af unormale åbninger (fistler) mellem din tarm og hud, der ikke har kunnet behandles tilfredsstillende med andre lægemidler eller operation.
English: There is no evidence to suggest that infliximab worsens or causes fibrotic strictures.
Danish: Der er ingen tegn på, at infliximab forværrer eller forårsager fibrotiske strikturer.
English: The powder is a freeze-dried white pellet.
Danish: Pulveret er en frysetørret hvid pellet.
English: After the first year of the study, 78 patients continued into an open-label extension to week 98.
Danish: Efter studiets første år fortsatte 78 patienter i en openlabel forlængelse til uge 98.
English: In addition:
Danish: Derudover gælder, at:
English: Discontinuation of Remicade should be considered if these disorders develop.
Danish: Det bør overvejes at afbryde Remicade-behandlingen, hvis disse forstyrrelser fortsætter.
English: The combination of Remicade and abatacept is not recommended.
Danish: Kombinationen af Remicade og abatacept anbefales ikke.
English: • Tell your doctor if you have or have ever had a problem that affects your nervous system before you are given Remicade.
Danish: • Fortæl din læge, hvis du har eller nogensinde har haft en lidelse, som påvirker dit nervesystem, før du får Remicade.
English: Cases of agranulocytosis have also been reported (see section 4.8).
Danish: Der er også set tilfælde af agranulocytose (se pkt.
English: • Changes in how your liver works, increase in liver enzymes (shown in blood tests)
Danish: • Ændringer i hvordan din lever fungerer, forhøjede leverenzymer (vist i blodprøver)
English: An association between development of antibodies to infliximab and reduced duration of response has also been observed.
Danish: En sammenhæng mellem udvikling af antistoffer over for infliximab og reduceret varighed af respons er også blevet observeret.
English: It is important that you tell your baby's doctors and other healthcare professionals about your Remicade use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis).
Danish: Det er vigtigt, at du fortæller dit barns læger og andet sundhedspersonale, at du får Remicade, så de kan finde frem til, hvornår dit barn skal vaccineres; det gælder også levende vacciner som BCG (bruges til at forebygge tuberkulose).
English: Remove flip-top from the vial and wipe the top with a 70% alcohol swab.
Danish: Fjern plastiklåget fra hætteglasset og tør toppen med en 70 % alkoholvatpind.
English: All 3 groups received repeated infusions at week 2, 6 and every 8 weeks thereafter.
Danish: Alle 3 grupper modtog gentagne infusioner i uge 2 og 6 samt hver 8. uge derefter.
English: There was no significant difference between placebo and infliximab for the proportion of patients with sustained closure of all fistulas through week 54, for symptoms such as proctalgia, abscesses and urinary tract infection or for number of newly developed fistulas during treatment.
Danish: Der var ingen signifikant forskel mellem placebo og infliximab i andelen af patienter med forlænget lukning af alle fistler til og med uge 54, med symptomer som proctalgia, abscesser og urinrørsinfektion eller i antallet af nyudviklede fistler under behandlingen.
English: Rare: Endophthalmitis.
Danish: Sjælden: Endoftalmitis.
English: Clinical Remission
Danish: Klinisk remission
English: Of the 573 patients randomised, 335 (58%) achieved clinical response by week 2.
Danish: Af de 573 randomiserede patienter, opnåede 335 (58 %) klinisk respons ved uge 2.
English: Patients should be advised of and avoid exposure to potential risk factors for infection as appropriate.
Danish: Patienter bør informeres efter behov og undgå at blive udsat for potentielle risikofaktorer for infektion.
English: Patients who discontinue immunosuppressants prior to or during Remicade treatment are at greater risk of developing these antibodies.
Danish: Patienter, der får seponeret immunsuppressiva før eller under Remicadebehandling, har større risiko for at udvikle disse antistoffer.
English: In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of Remicade (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour.
Danish: Hos nøje udvalgte voksne patienter, som har tålt mindst 3 initiale 2-timers infusioner med Remicade (induktionsfase) og får vedligeholdelsesterapi, kan det overvejes at indgive de efterfølgende infusioner over en periode på ikke mindre end 1 time.
English: At baseline, 87% of the patients had perianal fistulae, 14% had abdominal fistulae, 9% had rectovaginal fistulae.
Danish: Ved baseline havde 87 % af patienterne perianale fistler, 14 % havde abdominale fistler, 9 % havde rectovaginale fistler.
English: The primary endpoints were the reduction of signs and symptoms as assessed by the American College of Rheumatology criteria (ACR20 for ATTRACT, landmark ACR-N for ASPIRE), the prevention of structural joint damage, and the improvement in physical function.
Danish: De primære endepunkter var reduktionen af sygdomstegn og symptomer, i henhold til American College of Rheumatology kriterier (ACR20 for ATTRACT, grænsebestemt ACR-N for ASPIRE), forebyggelsen af strukturel ledskade og forbedringen af fysisk funktionsevne.
English: If an infusion reaction occurs in association with a shortened infusion, a slower infusion rate may be considered for future infusions if treatment is to be continued.
Danish: Hvis der opstår en infusionsreaktion i forbindelse med den forkortede infusionstid, kan en langsommere infusionshastighed overvejes ved fremtidige infusioner, hvis behandlingen skal fortsættes.
English: You should not be given Remicade if:
Danish: Du må ikke få Remicade hvis:
English: The concomitant use of infliximab with these biologics is not recommended because of the possibility of an increased risk of infection, and other potential pharmacological interactions.
Danish: Samtidig brug af infliximab og disse biologiske lægemidler anbefales ikke på grund af øget risiko for infektioner og andre potentielle farmakologiske interaktioner.
English: Re-administration for Crohn's disease and rheumatoid arthritis If the signs and symptoms of disease recur, Remicade can be re-administered within 16 weeks following the last infusion.
Danish: Fornyet indgift ved Crohns sygdom og reumatoid arthritis Hvis tegn og symptomer på sygdom vender tilbage, kan Remicade indgives på ny inden for 16 uger efter den seneste infusion.
English: The card is aimed at both serving as a reminder to record the dates and outcomes of specific tests and to facilitate the patient sharing of special information with healthcare professionals(s) (HCPs) treating the patient about on-going treatment with the product.
Danish: Kortet fungerer både som en påmindelse om at registrere datoer for og resultater af specifikke test og gør det lettere for patienten at dele særlige oplysninger med de sundhedspersoner, der behandler patienten, om den igangværende behandling med lægemidlet.
English: No major age-related differences in clearance or volume of distribution were observed in clinical studies.
Danish: Der er ikke iagttaget større aldersrelaterede forskelle i clearance eller fordelingsvolumen i kliniske studier.
English: The proportion of subjects who underwent colectomy at any time within 54 weeks following the first infusion of study agent were collected and pooled from the ACT 1 and ACT 2 studies and their extensions.
Danish: Andelen af forsøgspersoner, som fik foretaget kolektomi på et hvilket som helst tidspunkt indenfor 54 uger efter den første infusion af studiemedicin, blev samlet fra ACT 1 og ACT 2 studierne og deres forlængelser.
English: The Health Assessment Questionnaire (HAQ; scale 0-3) was used to measure patients' average change from baseline scores over time, in physical function.
Danish: Health Assessment Questionnaire (HAQ; scale 0-3) blev anvendt til at måle patienternes gennemsnitlige ændring i fysisk funktionsevne fra baseline scores over tiden.
English: After 54 weeks of treatment, both doses of infliximab + methotrexate resulted in statistically significantly greater improvement in signs and symptoms compared to methotrexate alone as measured by the proportion of patients achieving ACR20, 50 and 70 responses.
Danish: Efter 54 ugers behandling resulterede begge doser af infliximab + methotrexat i statistisk signifikant større forbedring i tegn og symptomer sammenlignet med methotrexat alene, målt ved andelen af patienter, der opnåede ACR20, 50 og 70 respons.
English: The volume of distribution at steady state (median Vd of 3.0 to 4.1 litres) was not dependent on the administered dose and indicated that infliximab is predominantly distributed within the vascular compartment.
Danish: Fordelingsvolumen ved steady state (median Vd på 3,0 til 4,1 liter) var ikke afhængig af den indgivne dosis og indikerede, at infliximab især distribueres i det vaskulære fordelingsrum.
English: Patients must be monitored closely for infections including tuberculosis before, during and after treatment with Remicade.
Danish: Patienter skal følges tæt for infektioner, inklusive tuberkulose før, under og efter behandling med Remicade.
English: • A statement that the brand name and batch number should be recorded
Danish: • En meddelelse om, at produktnavn og lot-nummer skal registreres.
English: Upper respiratory tract infection (7/60 [12%]) and pharyngitis (5/60 [8%]) were the most frequently reported respiratory system infections.
Danish: Øvre luftvejsinfektion (7/60 [12 %]) og faryngitis (5/60 [8 %]) var de hyppigst rapporterede luftvejsinfektioner.
English: If patients are re-treated after a prolonged period, they must be closely monitored for signs and symptoms of delayed hypersensitivity.
Danish: Hvis patienter genbehandles efter en længere periode, skal de følges nøje vedrørende tegn og symptomer på forsinket overfølsomhed.
English: Names and addresses of the manufacturer(s) of the biological active substance(s)
Danish: Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer)
English: Particular attention regarding the risk for infection should be paid when treating the elderly (see section 4.8).
Danish: Der bør tages særligt hensyn til risikoen for infektion, når ældre behandles (se pkt.
English: Table 7 Effects on response rate, data from ACCENT II (week-14 responders) ACCENT II (week-14 responders) Placebo Maintenance (n = 99)
Danish: Tabel 7 Effekter på responshastighed, data fra ACCENT II (uge-14 responderende) ACCENT II (uge-14 responderende) Placebo Vedligeholdelse( n = 99)
English: • Inflammation in the eye that may cause changes in the vision, including blindness
Danish: • Øjenbetændelse, der kan forårsage synsforandringer, inklusive blindhed
English: ACR-N uses the same criteria as the ACR20, calculated by taking the lowest percent improvement in swollen joint count, tender joint count, and the median of the remaining 5 components of the ACR response.
Danish: ACR-N anvender de samme kriterier som ACR20, beregnet ved at tage den laveste procentvise forbedring i antallet af hævede led, antallet af ømme led og medianen af de sidste 5 komponenter af ACR responset.
English: Not known: Vaccine breakthrough infection (after in utero exposure to infliximab)*.
Danish: Ikke kendt: Gennembrudsinfektion efter vaccination (efter eksponering for infliximab i uterus)*
English: In the infliximab group, the mean change in total modified vdH-S score remained below 0 at the week 54 timepoint.
Danish: I infliximab-gruppen forblev middelændringen i samlet modificeret vdH-S score under 0 i uge 54.
English: Mean baseline NAPSI scores were 4.6 and 4.3 in infliximab and placebo group.
Danish: Gennemsnitlig NAPSIscore ved baseline var hhv. 4,6 og 4,3 i infliximab- og placebogruppen.
English: Significant improvements from baseline were demonstrated in DLQI (p < 0.001) and the physical and mental component scores of the SF 36 (p < 0.001 for each component comparison).
Danish: Der blev registreret signifikante forbedringer fra baseline i DLQI (p < 0,001) og de fysiske og mentale del-scorer af SF 36 (p < 0,001 for hver enkelt delsammenligning).
English: However, before Remicade is given to you, it is mixed with a solution that contains sodium.
Danish: Men før du får Remicade, blandes det sammen med en opløsning, som indeholder natrium.
English: Based on patients with PASI ≥ 2.5 at baseline for IMPACT, and patients with ≥ 3% BSA psoriasis skin involvement at baseline in IMPACT 2.
Danish: Baseret på patienter med PASI > 2.5 ved baseline for IMPACT, og patienter med > 3 % BSA psoriasis hud påvirkning ved baseline af IMPACT 2.
English: In addition, statistically and clinically significant improvements in quality of life and height, as well as a significant reduction in corticosteroid use, were observed versus baseline.
Danish: Derudover blev der obseveret statistisk og klinisk signifikante forbedringer af livskvalitet og højde såvel som en signifikant reduktion i brug af kortikosteroid i forhold til baseline.
English: However, the results are uncertain due to limitations in the methods used for serum analyses of infliximab and antibodies against infliximab.
Danish: Resultaterne er dog usikre på grund af begrænsninger i de anvendte metoder til serumanalyser af infliximab og antistoffer mod infliximab.
English: 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Danish: mercaptopurin (6-MP) eller azathioprin (AZA), eller som er intolerante over for eller har kliniskekontraindikationer for sådanne behandlinger.
English: Rheumatoid arthritis The usual dose is 3 mg for every kg of body weight.
Danish: Reumatoid arthritis Den sædvanlige dosis er 3 mg pr. kg kropsvægt.
English: The proportion of patients in clinical response at week 8 was 73.3% (44/60).
Danish: Andelen af patienter med klinisk respons i uge 8 var 73,3 % (44/60).
English: • Tell your doctor straight away if you have signs of an infection.
Danish: • Fortæl straks din læge, hvis du har tegn på en infektion.
English: Results from week 54 (ACR20, total van der Heijde-modified Sharp score and HAQ) are shown in Table 3.
Danish: Resultater fra uge 54 (ACR20, total van der Heijde-modified Sharp score og HAQ) er vist i tabel 3.
English: Dosing continued for all patients through week 46.
Danish: Dosis fortsatte for alle patienter til og med uge 46.
English: Table 5 Effects on response and remission rate, data from ACCENT I (week-2 responders) ACCENT I (week-2 responders) % of Patients
Danish: Tabel 5 Effekter på respons og remissionshastighed, data fra ACCENT I (uge-2 responderende) ACCENT I (uge-2 responderende) % Patienter
English: The usual dose is 5 mg for every kg of body weight.
Danish: Den sædvanlige dosis er 5 mg pr. kg kropsvægt.
English: • Infection due to a live vaccine because of a weakened immune system.
Danish: • Infektion, der skyldes en levende vaccine, som følge af et svækket immunsystem.
English: TNF alpha is involved in inflammatory processes of the body so blocking it can reduce the inflammation in your body.
Danish: TNF alfa er involveret i kroppens betændelsesprocesser, så blokering af dette kan mindske betændelsen i din krop.
English: Experimental data show that TNF is essential for the clearing of intracellular infections.
Danish: Eksperimentelle data viser, at TNF er afgørende for at bekæmpe intracellulære infektioner.
English: In clinical studies, delayed hypersensitivity reactions have been reported.
Danish: I kliniske studier har forsinkede overfølsomhedsreaktioner været rapporteret.
English: Reconstitute and dilute before use.
Danish: Rekonstituer og fortynd før brug.
English: Overall proportions of adverse events and infusion reactions were similar between the 6 to 11 and 12 to 17 year age groups.
Danish: Samlet set var hyppigheden af bivirkninger og infusionsreaktioner den samme i aldersgrupperne 611 år og 12-17 år.
English: Sustained remission (in remission at both week 8 and week 30)
Danish: Vedvarende remission (i remission både i uge 8 og uge 30)
English: Patients who develop a new infection while undergoing treatment with Remicade, should be monitored closely and undergo a complete diagnostic evaluation.
Danish: Patienter, som udvikler en ny infektion, imens de er under behandling med Remicade, bør monitoreres tæt og gennemgå en komplet diagnostisk evaluering.
English: If response was lost during maintenance treatment, crossing over to a higher dose (10 mg/kg) and/or shorter dosing interval (q8 weeks) was allowed.
Danish: Hvis respons forsvandt under vedligeholdelsesbehandlingen, var cross-over til en højere dosis (10 mg/kg) og/eller kortere doseringsinterval (hver 8. uge) tilladt.
English: In P01522, improvement in signs and symptoms was also observed as early as week 2.
Danish: I P01522 sås forbedring af tegn og symptomer så tidligt som i uge 2.
English: control = All patients had active RA despite treatment with stable methotrexate doses for 6 months prior to enrolment and were to remain on stable doses throughout the study.
Danish: Kontrol = Alle patienter havde aktiv RA på trods af behandling med stabile methotrexat doser i 6 måneder før inklusion og skulle fortsætte på stabile doser gennem studiet.
English: All patients had experienced an inadequate response to prior conventional therapies.
Danish: Alle patienter havde haft utilstrækkelig effekt af tidligere konventionel behandling.
English: Although comparative data are lacking, limited data in patients who initially responded to 5 mg/kg but who lost response indicate that some patients may regain response with dose escalation (see section 5.1).
Danish: Selvom sammenlignende resultater mangler, indikerer begrænsede data hos patienter, der initialt responderede på 5 mg/kg, men som mistede respons, at nogle patienter kan genvinde respons med dosisoptrapning (se pkt.
English: Rare: Apathy.
Danish: Sjælden: Apati
English: • Tell your surgeon or dentist that you are having treatment with Remicade by showing them your patient reminder card.
Danish: • Fortæl kirurgen eller tandlægen, at du er i behandling med Remicade ved at vise dem dit patientinformationskort.
English: There are insufficient preclinical data to draw conclusions on the effects of infliximab on fertility and general reproductive function (see section 5.3).
Danish: Der er ikke tilstrækkelige prækliniske data til at drage konklusioner om infliximabs virkning på fertilitet og generel reproduktion (se pkt.
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with antituberculosis therapy before the initiation of Remicade, and in accordance with local recommendations.
Danish: Hvis inaktiv (“latent”) tuberkulose diagnosticeres, skal behandling for latent tuberkulose påbegyndes med behandling mod tuberkulose før initiering af Remicadebehandling i henhold til lokale vejledninger.
English: This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Danish: Denne sjældne type af Tcelle-lymfom har et meget aggressivt sygdomsforløb og er sædvanligvis fatal.
English: • Your blood not supplying enough oxygen to your body, circulation problems such as narrowing of a blood vessel
Danish: • Blodet tilfører ikke nok ilt til kroppen, kredsløbsproblemer såsom indsnævring af et blodkar
English: Foaming of the solution on reconstitution is not unusual.
Danish: Opskumning af koncentratet ved rekonstitution er ikke usædvanligt.
English: Furthermore, improved quality of life as measured by IBDQ was observed with infliximab.
Danish: Desuden blev der observeret forbedret livskvalitet ved infliximab-behandling, målt med IBDQ.
English: Name patient:
Danish: Patientens navn:
English: All patients administered Remicade are to be observed for at least 1-2 hours post-infusion for acute infusion-related reactions.
Danish: Alle patienter, der har fået Remicade, skal observeres i mindst 1-2 timer efter infusionen for akutte infusionsrelaterede reaktioner.
English: Clinical remission at week 8 was 33.3% (17/51) as measured by the Paediatric Ulcerative Colitis Activity Index (PUCAI) score.
Danish: Klinisk remission i uge 8 var 33,3 % (17/51) målt ved pædiatrisk colitis ulcerosa aktivitets-indeks (PUCAI) scoren.
English: Remicade contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Danish: Remicade indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. det er i det væsentlige ”natriumfrit”.
English: No specific ophthalmologic examinations have been performed in patients to investigate the relevance of this finding for humans.
Danish: Ingen specifikke øjenundersøgelser er blevet udført hos patienter for at vurdere relevansen af dette fund for mennesker.
English: Rare: Granulomatous lesion.
Danish: Sjælden: Granulomatøs læsion.
English: • Your doctor should test you for hepatitis B virus.
Danish: • Din læge skal teste dig for hepatitis B.
English: Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury.
Danish: Patienter med symptomer eller tegn på nedsat leverfunktion bør undersøges for tegn på leverskade.
English: Your doctor will advise you what other medicines you must keep using while you are having Remicade.
Danish: Din læge vil rådgive dig om, hvilke andre lægemidler du skal blive ved med at tage, mens du er i behandling med Remicade.