FrancophonIA/ELRC3.0 huggingface dataset:
English: The concomitant use of Flixabi 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 Flixabi og disse biologiske lægemidler anbefales ikke på grund af øget risiko for infektioner og andre potentielle farmakologiske interaktioner.
English: 3 Number of patients evaluated for ALT.
Danish: 3 Antal patienter, som er evalueret for ALAT.
English: Before starting treatment with Flixabi, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Danish: Før initiering af behandling med Flixabi skal alle patienter vurderes for både aktiv og inaktiv (“latent”) tuberkulose.
English: Before reconstitution 4 years at 2°C - 8°C.
Danish: Før rekonstitution: 4 år ved 2 °C - 8 °C.
English: ACR 20 response* ACR 50 response* ACR 70 response* PASI response (% of patients)b
Danish: ACR 20 respons* 5(10 %) ACR 50 respons* ACR 70 respons* PASI respons (% af patienter)b
English: In all situations described below, the benefit/risk balance of Flixabi therapy should be very carefully considered.
Danish: I alle situationer beskrevet nedenfor bør benefit/risk-balancen af Flixabibehandling vurderes meget nøje.
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 6-11 år og 12-17 år.
English: In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of Flixabi (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 Flixabi (induktionsfase) og får vedligeholdelsesterapi, kan det overvejes at indgive de efterfølgende infusioner over en periode på ikke mindre end 1 time.
English: Week 10 Week 24
Danish: Uge 10 Uge 24
English: Table 2 Proportion of patients with increased ALT activity in clinical studies
Danish: Tabel 2 Andel patienter med øget ALAT-aktivitet i kliniske studier Indikation Antal patienter
English: Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis).
Danish: Interstitiel lungesygdom (inklusive hurtigt fremadskridende sygdom, lungefibrose og pneumonitis).
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 observeret statistisk og klinisk signifikante forbedringer af livskvalitet og højde såvel som en signifikant reduktion i brug af kortikosteroid i forhold til baseline.
English: Keep this card with you for 4 months after your dose of Flixabi, 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, når du har fået din dosis Flixabi, eller i tilfælde af graviditet i mindst 6 måneder, efter du har født.
English: Mean baseline NAPSI scores were 4.6 and 4.3 in infliximab and placebo group.
Danish: Gennemsnitlig NAPSI- score ved baseline var hhv. 4,6 og 4,3 i infliximab- og placebogruppen.
English: All patients administered Flixabi are to be observed for at least 1-2 hours post-infusion for acute infusion-related reactions.
Danish: Alle patienter, der har fået Flixabi, skal observeres i mindst 1-2 timer efter infusionen for akutte infusionsrelaterede reaktioner.
English: In all cases, infliximab treatment was discontinued and/or other treatment instituted with complete resolution of signs and symptoms.
Danish: I alle tilfælde blev infliximab seponeret og/eller anden behandling igangsat med fuldstændig ophør at tegn og symptomer.
English: The efficacy of infliximab through week 54 was assessed in the ACT 1 study.
Danish: Effekten af infliximab til og med uge 54 blev undersøgt i ACT 1 studiet.
English: Granulomatous lesion.
Danish: Granulomatøs læsion.
English: e HAQ = Health Assessment Questionnaire; greater values indicate less disability.
Danish: e HAQ = Health Assessment Questionnaire; større værdier indikerer mindre uarbejdsdygtighed.
English: • If you have had a break in your treatment with infliximab of more than 16 weeks, there is a higher risk for allergic reactions when you start the treatment again.
Danish: Hvis du har holdt pause i behandlingen med infliximab i over 16 uger, er der en højere risiko for at få en allergisk reaktion, når du starter behandlingen igen.
English: The combination of Flixabi and abatacept is not recommended.
Danish: Kombinationen af Flixabi og abatacept anbefales ikke.
English: Further treatment with Flixabi must not be given if a patient develops a serious infection or sepsis.
Danish: Behandling med Flixabi må ikke fortsættes, hvis en patient udvikler en alvorlig infektion eller sepsis.
English: Complement factor abnormal.
Danish: Komplementfaktorabnormitet.
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C.
Danish: Hvis det ikke anvendes straks, er opbevaringstiderne og -betingelserne efter anbrud indtil anvendelse brugerens ansvar, og de bør ikke overskride 24 timer ved 2 °C til 8 °C.
English: The following side effects have been observed with infliximab:
Danish: Følgende bivirkninger er observeret med infliximab:
English: Experimental data show that TNFα is essential for the clearing of intracellular infections.
Danish: Eksperimentelle data viser, at TNFα er afgørende for at bekæmpe intracellulære infektioner.
English: From a microbiological point of view, the product should be used as soon as possible but within 3 hours of reconstitution and dilution.
Danish: Ud fra et mikrobiologisk synspunkt bør præparatet anvendes snarest muligt, og inden for 3 timer efter rekonstitution og fortynding.
English: Median (Interquartile range) Patients with no deterioration/patients evaluated (%)
Danish: (Interkvartil interval) Patienter uden forværring/patienter evalueret c
English: Your doctor will advise you what other medicines you must keep using while you are having Flixabi.
Danish: Din læge vil rådgive dig om, hvilke andre lægemidler du skal blive ved med at tage, mens du er i behandling med Flixabi.
English: Chemical and physical in use stability of the reconstituted solution has been demonstrated for 24 hours at 25°C.
Danish: Den rekonstituerede opløsnings kemiske og fysiske stabilitet efter anbrud er påvist i 24 timer ved 25 °C.
English: • Flixabi will be given to you by your doctor or nurse.
Danish: • Du vil få Flixabi af din læge eller sygeplejerske.
English: Long-term studies have not been performed to evaluate the carcinogenic potential of infliximab.
Danish: Langvarende studier er ikke blevet udført for at vurdere karcinogenicitet af infliximab.
English: Flixabi works by selectively attaching to TNF alpha and blocking its action.
Danish: Flixabi virker ved selektivt at binde sig til TNF alfa og blokere dets virkning.
English: Therefore, the combination of Flixabi and anakinra is not recommended.
Danish: Derfor kan kombination af Flixabi og anakinra ikke anbefales.
English: • Do not use this medicine if it is discoloured or if there are particles present.
Danish: • Brug ikke lægemidlet, hvis det er misfarvet, eller hvis det indeholder partikler.
English: Subjects randomised Percentage ACR improvement Mean ± SD
Danish: Forsøgspersoner randomiseret Procentvis ACR forbedring Gennemsnit ± SDa
English: ACR response (% of patients) N
Danish: ACR respons (% af patienter)
English: N ≥ 90% improvement ≥ 75% improvement ≥ 50% improvement
Danish: N ≥ 90 % forbedring ≥ 75 % forbedring ≥ 50 % forbedring
English: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last Flixabi treatment.
Danish: Kvinder i den fertile alder skal overveje at anvende sikker kontraception for at undgå graviditet og fortsætte med anvendelsen heraf i mindst 6 måneder efter den sidste behandling med Flixabi.
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: • Tell your doctor if you have had treatment with medicines containing infliximab in the past and are now starting Flixabi treatment again.
Danish: • Fortæl din læge, hvis du tidligere har været i behandling med lægemidler indeholdende infliximab og nu starter behandling med Flixabi igen.
English: For storage conditions up to 25°C before reconstitution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold på op til 25 °C før rekonstitution af lægemidlet, se pkt.
English: Sustained remission (in remission at both week 8 and week 30)
Danish: Vedvarende remission (i remission både i uge 8 og uge 30)a
English: Almost all patients had also received medicines containing azathioprine or 6mercaptopurine in addition to TNF-blockers.
Danish: Næsten alle patienterne havde også fået medicin, der indeholder azathioprin eller 6-mercaptopurin ud over den TNF-blokerende behandling.
English: At single doses of 3, 5, or 10 mg/kg, the median Cmax values were 77, 118 and 277 micrograms/mL, respectively.
Danish: Ved enkeltdoser på 3, 5 eller 10 mg/kg var median værdier for Cmax henholdsvis 77, 118 og 277 mikrogram/ml.
English: Autoantibody positive.
Danish: Positiv for autoantistoffer.
English: Cases of tuberculosis, sometimes fatal, including miliary tuberculosis and tuberculosis with extrapulmonary location have been reported (see section 4.4).
Danish: Tilfælde af tuberkulose, undertiden dødelige, inklusive miliær tuberkulose og tuberkulose med ekstrapulmonal placering har været rapporteret (se pkt.
English: • A reminder to patients to show the patient reminder card to all treating HCPs, including in conditions of emergency, and a message for HCPs that the patient is using Flixabi
Danish: • En påmindelse til patienterne om, at de skal vise patientinformationskortet til alle behandlende sundhedspersoner, herunder i nødstilfælde, og en besked til sundhedspersoner om, at patienten anvender Flixabi.
English: Patients who discontinue immunosuppressants prior to or during infliximab treatment are at greater risk of developing these antibodies.
Danish: Patienter, der får seponeret immunsuppressiva før eller under infliximabbehandling, har større risiko for at udvikle disse antistoffer.
English: If you are given too much Flixabi
Danish: Hvis du får for meget Flixabi
English: Endophthalmitis.
Danish: Endoftalmitis.
English: Warnings and precautions Talk to your doctor before or during treatment with Flixabi if you have:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før eller under behandlingen med Flixabi, hvis du har:
English: Flixabi should only be used in children and adolescents if they are being treated for Crohn`s disease or ulcerative colitis.
Danish: Flixabi må kun anvendes til børn og unge, hvis de behandles for Crohns sygdom eller colitis ulcerosa.
English: In infliximab treated subjects, significant PASI 50 responses were apparent at the first visit (week 2) and PASI 75 responses by the second visit (week 6).
Danish: Hos infliximab- behandlede personer var signifikant PASI 50 respons tydelig ved det første besøg (uge 2) og PASI 75 respons ved det andet besøg (uge 6).
English: • Worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
Danish: • Forværring af en sygdom, der kaldes dermatomyositis (observeres som hududslæt ledsaget af muskelsvaghed)
English: Re-administration for Crohn's disease and rheumatoid arthritis If the signs and symptoms of disease recur, Flixabi 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 Flixabi indgives på ny inden for 16 uger efter den seneste infusion.
English: In a clinical study of patients with rheumatoid arthritis (ASPIRE), infusions were to be administered over 2 hours for the first 3 infusions.
Danish: I et klinisk studie hos patienter med reumatoid arthritis (ASPIRE) skulle de 3 første infusioner indgives over 2 timer.
English: Patients must be monitored closely for infections including tuberculosis before, during and after treatment with Flixabi.
Danish: Patienter skal følges tæt for infektioner, inklusive tuberkulose før, under og efter behandling med Flixabi.
English: Side effects may also occur after your treatment with Flixabi has stopped.
Danish: Bivirkninger kan også opstå efter ophør af din behandling med Flixabi.
English: Since the possibility of increased risk of cancer development in patients with newly diagnosed dysplasia treated with infliximab is not established, the risk and benefits of continued therapy to the individual patients should be carefully considered by the clinician.
Danish: Da muligheden for øget risiko for udvikling af cancer hos patienter med nydiagnosticeret dysplasi behandlet med infliximab ikke er vist, bør risiko og gavn af fortsat behandling for de individuelle patienter nøje overvejes af lægen.
English: • It is very important that you tell your doctor if you have ever had tuberculosis (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: Ask your doctor to record the type and date of your last screening(s) for TB on the card.
Danish: Du skal bede din læge om at notere type og dato for din(e) seneste screening(er) for TB på kortet.
English: • Slow down the damage in your joints,
Danish: • Forsinke skaden i dit led
English: During Flixabi treatment, other concomitant therapies, e.g. corticosteroids and immunosuppressants should be optimised.
Danish: Under Flixabi-behandling bør anden samtidig behandling såsom kortikosteroider og immunsuppressiva optimeres.
English: Hypersensitivity to the active substance, to other murine proteins, or to any of the excipients listed in section
Danish: Overfølsomhed over for det aktive stof, over for andre murine proteiner eller over for et eller flere af hjælpestofferne anført i pkt.
English: If jaundice and/or ALT elevations ≥ 5 times the upper limit of normal develop(s), Flixabi should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Danish: Hvis der opstår gulsot og/eller ALAT- forhøjelser ≥ 5 gange øvre grænse af normalområdet, bør Flixabi seponeres, og et omhyggelig studie af hændelsen bør foretages.
English: Patients who develop a new infection while undergoing treatment with Flixabi, should be monitored closely and undergo a complete diagnostic evaluation.
Danish: Patienter, som udvikler en ny infektion, imens de er under behandling med Flixabi, bør monitoreres tæt og gennemgå en komplet diagnostisk evaluering.
English: Flixabi may have a minor influence on the ability to drive and use machines.
Danish: Flixabi kan evt. i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Check that the solution is colourless to light yellow and opalescent.
Danish: Kontroller at opløsningen er farveløs til lysegul og opaliserende.
English: • Tell your surgeon or dentist that you are having treatment with Flixabi by showing them your patient reminder card.
Danish: • Fortæl kirurgen eller tandlægen, at du er i behandling med Flixabi ved at vise dem dit patientinformationskort.
English: Due to its inhibition of TNFα, infliximab administered during pregnancy could affect normal immune responses in the newborn.
Danish: På grund af hæmningen af TNFα kan infliximab indgivet under graviditet påvirke det normale immunrespons hos den nyfødte.
English: In most fistulising Crohn's disease patients, infliximab was detected in serum for 12 weeks (range 4-28 weeks) after administration of the regimen.
Danish: I de fleste patienter med fistulerende Crohns sygdom blev infliximab påvist i serum i 12 uger (interval 4- 28 uger) efter indgift af regimen.
English: Placebo Maintenance (n=99)
Danish: Placebo Vedligeholdelse (n = 99)
English: N ≥ 90% improvement
Danish: N ≥ 90 % forbedring
English: The median duration of follow-up was 0.8 years (incidence 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: Flixabi is not likely to affect your ability to drive or use tools or machines.
Danish: Flixabi påvirker sandsynligvis ikke din evne til at føre motorkøretøj eller betjene værktøj eller maskiner.
English: In vivo, infliximab rapidly forms stable complexes with human TNFα, a process that parallels the loss of TNFα bioactivity.
Danish: In vivo danner infliximab hurtigt stabile komplekser med human TNFα, en proces der svarer til tabet af TNFα bioaktivitet.
English: There are no known side effects of having too much of Flixabi.
Danish: Der kendes ikke til nogen bivirkninger efter at have fået for meget Flixabi.
English: During clinical studies of infliximab across all approved indications the incidence of lymphoma in infliximab-treated patients was higher than expected in the general population, but the occurrence of lymphoma was rare.
Danish: Under kliniske studier med infliximab over alle godkendte indikationer var forekomsten af lymfom hos infliximab-behandlede patienter højere end forventet i den generelle befolkningsgruppe, men forekomsten af lymfom var sjælden.
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with antituberculosis therapy before the initiation of Flixabi, 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 Flixabibehandling i henhold til lokale vejledninger.
English: It is important that you tell your baby's doctors and other health care professionals about your Flixabi 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 Flixabi, så de kan finde frem til, hvornår dit barn skal vaccineres; det gælder også levende vacciner som BCG (bruges til at forebygge tuberkulose).
English: In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 patientsyears (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported.
Danish: I længerevarende sikkerhedsopfølgninger af kliniske studier med infliximab på op til 5 år, svarende til 6.234 patientår (3.210 patienter), blev der rapporteret 5 tilfælde af lymfom og 38 tilfælde af nonlymfom maligniteter.
English: Flixabi contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Danish: Flixabi indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. det er i det væsentlige ”natriumfrit”.
English: a Reduction in CDAI ≥ 25% and ≥ 70 points.
Danish: Vedblivende steroidfri remissionb a Reduktion i CDAI ≥ 25 % og ≥ 70 point.
English: Analysis of lamina propria mononuclear cells obtained by biopsy of the intestinal mucosa showed that infliximab treatment caused a reduction in the number of cells capable of expressing TNFα and interferon γ.
Danish: Analyse af lamina propria mononukleære celler udtaget ved biopsi fra den intestinale mucosa viste, at infliximab-behandling forårsagede en reduktion i antallet af celler, som var i stand til at udtrykke TNFα og interferon-γ.
English: In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, antituberculosis therapy should be considered before the initiation of Flixabi.
Danish: Hos patienter, der har adskillige eller signifikante risikofaktorer for tuberkulose og har en negativ test for latent tuberkulose, bør anti-tuberkulosebehandling overvejes før initieringen af Flixabi.
English: Infliximab has not been studied in these patient populations.
Danish: Infliximab er ikke undersøgt hos denne patientpopulation.
English: ≥ 50% improvement PGA of cleared (0) or minimal (1)
Danish: ≥ 50 % forbedring PGA helt væk (0) eller minimale (1)
English: Specific studies of infliximab in elderly patients have not been conducted.
Danish: Der er ikke udført specifikke studier af infliximab hos ældre patienter.
English: The most common adverse event was worsening of ulcerative colitis, the incidence of which was higher in patients on the q12 week vs. the q8 week dosing regimen.
Danish: Den almindeligste utilsigtede hændelse var forværring af colitis ulcerosa, hvor hyppigheden var større hos patienter i 12-ugers behandlingsregimen vs. 8-ugers behandlingsregimen.
English: d p = 0.030 and < 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX.
Danish: d p = 0,030 og < 0,001 for henholdsvis 3 mg/kg og 6 mg/kg behandlingsgruppen mod placebo + MTX.
English: Histological evaluation of colonic biopsies, obtained before and 4 weeks after administration of infliximab, revealed a substantial reduction in detectable TNFα.
Danish: Histologisk evaluering af biopsier fra colon, som er udtaget før og 4 uger efter indgivelse af infliximab, viste en betydelig reduktion i påviseligt TNFα.
English: Flixabi should be used with caution in patients with mild heart failure (NYHA class I/II).
Danish: Flixabi bør anvendes med forsigtighed hos patienter med let hjerteinsufficiens (NYHA funktionsklasse I/II).
English: All patients were required to be on a stable dose of 6-MP, AZA or MTX (35% were also receiving corticosteroids at baseline).
Danish: Alle patienterne skulle være på en stabil dosis af 6- MP, AZA eller MTX (35 % fik også kortiokosteroid ved baseline).
English: * Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Danish: * Infliximab er et kimerisk monoklonalt human-murin IgG1-antistof fremstillet i celler fra kinesiske hamsterovarier (CHO) ved rekombinant DNA-teknologi.
English: • It is recommended that when Flixabi is prepared for infusion, it is used as soon as possible (within 3 hours).
Danish: • Det anbefales, at Flixabi anvendes så hurtigt som muligt (inden for 3 timer), efter det er klargjort til infusion.
English: The ATTRACT study evaluated responses at 30, 54 and 102 weeks in a placebo-controlled study of 428 patients with active rheumatoid arthritis despite treatment with methotrexate.
Danish: ATTRACT studiet evaluerede responset ved ugerne 30, 54 og 102 i en placebokontrolleret studie hos 428 patienter med aktiv reumatoid arthritis på trods af behandling med methotrexat.
English: For preparation and administration instructions, see section 6.6.
Danish: For instruktioner om tilberedning og administration, se pkt.
English: In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of infliximab, or modification of concomitant therapy.
Danish: Generelt var patienter, der udviklede ALAT og ASAT stigninger, asymptomatiske, og hændelserne bedredes eller forsvandt med enten fortsættelse eller afbrydelse af infliximab, eller justering af samtidig behandling.
English: Had treatment with any medicine containing infliximab before
Danish: Været i behandling med lægemidler indeholdende infliximab tidligere
English: Appropriate screening tests, e.g. tuberculin skin test, chest X-ray, and/or Interferon Gamma Release Assay), should be performed in all patients (local recommendations may apply).
Danish: Passende screeningundersøgelser (fx tuberkulintest, røntgen af thorax og/eller Interferon Gamma Relase Assay) bør udføres hos alle patienter (lokale vejledninger kan være gældende).
English: • Low blood counts, including a severely decreased number of white blood cells.
Danish: • Lave blodtal, herunder svært nedsat antal hvide blodlegemer.