FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients did not receive any concomitant immunosuppressant therapy.
Danish: Patienterne fik ingen samtidig immunsuppressiv behandling.
English: Significant improvements in health-related quality of life were also demonstrated as measured by the physical and mental component summary scores of the SF-36 in IMPACT 2.
Danish: Signifikant forbedring i helbredsrelateret livskvalitet blev også påvist, målt med den fysiske og mentale component summary score af SF-36 i IMPACT 2.
English: Cases of tuberculosis, sometimes fatal, including miliary tuberculosis and tuberculosis with extra-pulmonary 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: Available data suggest that the clinical response is usually achieved within 14 weeks of treatment, i.e. three doses.
Danish: Eksisterende resultater tyder på, at det kliniske respons sædvanligvis opnås inden for 14 ugers behandling, svarende til tre doser.
English: Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
Danish: Analysen var baseret på patienter med neglepsoriasis ved baseline (81,8 % af patienterne).
English: One serious infusion reaction (< 1%) occurred in a patient on infliximab monotherapy.
Danish: Der forekom én alvorlig infusionsrelateret reaktion (< 1 %) hos en patient på infliximab monoterapi.
English: If jaundice and/or ALT elevations ≥ 5 times the upper limit of normal develop(s), Remicade 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 Remicade seponeres, og et omhyggelig studie af hændelsen bør foretages.
English: Almost all patients had also received medicines containing azathioprine or 6-mercaptopurine in addition to TNF-blockers.
Danish: Næsten alle patienterne havde også fået medicin, der indeholder azathioprin eller 6mercaptopurin ud over den TNF-blokerende behandling.
English: Maintenance therapy with infliximab every 8 weeks significantly reduced disease-related hospitalisations and surgeries compared with placebo.
Danish: Vedligeholdelsesbehandling med infliximab hver 8. uge reducerede sygdomsrelateret hospitalisering og kirurgiske indgreb signifikant sammenlignet med placebo.
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: 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 Remicade.
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 Remicade.
English: • You have heart failure that is moderate or severe.
Danish: • Du har hjertesvigt i moderat eller svær grad.
English: In C0168T72, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever, and headache.
Danish: I C0168T72 var de almindeligste bivirkninger øvre luftvejsinfektion, faryngitis, abdominalsmerter, feber og hovedpine.
English: Remicade should be used with caution in patients with mild heart failure (NYHA class I/II).
Danish: Remicade bør anvendes med forsigtighed hos patienter med let hjerteinsufficiens (NYHA funktionsklasse I/II).
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 reumatiod arthritis (ASPIRE) skulle de 3 første infusioner indgives over 2 timer.
English: Before reconstitution: 3 years at 2 °C - 8 °C.
Danish: Før rekonstitution: 3 år ved 2°C - 8°C.
English: Shortened infusions at doses > 6 mg/kg have not been studied (see section 4.8).
Danish: Kortere infusionstid ved doser > 6 mg/kg er ikke blevet undersøgt (se pkt.
English: In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered medicinal product should be clearly recorded.
Danish: For at øge sporbarheden af biologiske lægemidler skal præparatnavnet og lot-nummeret på det administrerede lægemiddel tydeligt noteres.
English: If a patient has an inadequate response or loses response after this period, consideration may be given to increase the dose step-wise by approximately 1.5 mg/kg, up to a maximum of 7.5 mg/kg every 8 weeks.
Danish: Hvis en patient får en utilstrækkelig respons eller mangler respons efter denne periode, kan det overvejes at øge dosis trinvis med ca. 1,5 mg/kg op til et maksimum på 7,5 mg/kg hver 8. uge.
English: Concurrent use of stable doses of conventional therapies was permitted, and 83% of patients continued to receive at least one of these therapies.
Danish: Samtidig brug af stabile doser af konventionel behandling var tilladt, og 83 % af patienterne fortsatte brugen af mindst en af disse behandlinger.
English: Specific studies of Remicade in elderly patients have not been conducted.
Danish: Der er ikke udført specifikke studier af Remicade hos ældre patienter.
English: In all cases, Remicade treatment was discontinued and/or other treatment instituted with complete resolution of signs and symptoms.
Danish: I alle tilfælde blev Remicade seponeret og/eller anden behandling igangsat med fuldstændig ophør at tegn og symptomer.
English: In vivo, infliximab rapidly forms stable complexes with human TNF, a process that parallels the loss of TNF bioactivity.
Danish: In vivo danner infliximab hurtigt stabile komplekser med human TNF, en proces der svarer til tabet af TNF bioaktivitet.
English: • Tell your doctor if you have any heart problems, such as mild heart failure.
Danish: • Fortæl din læge, hvis du har nogen form for hjerteproblemer, såsom let hjertesvigt.
English: Number of patients evaluated for ALT.
Danish: Antal patienter, som er evalueret for ALAT.
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 Remicade treatment.
Danish: Kvinder i den fertile alder skal overveje at anvende sikker antikonception for at undgå graviditet og fortsætte med anvendelsen heraf i mindst 6 måneder efter den sidste behandling med Remicade.
English: Due to methodological limitations, a negative assay did not exclude the presence of antibodies to infliximab.
Danish: På grund af metodologiske begrænsninger udelukkede en negativ undersøgelse ikke forekomsten af antistoffer mod infliximab.
English: 178 of the 580 enrolled patients (30.7%) were defined as having severe disease (CDAI score > 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Danish: 178 af de 580 inkluderede patienter (30,7 %) blev defineret som havende svær sygdom (CDAI score > 300 og samtidig kortikoid og/eller immunsupprimerende behandling) svarende til populationen defineret i indikationen (se pkt.
English: An infusion-related reaction was defined in clinical studies as any adverse event occurring during an infusion or within 1 hour after an infusion.
Danish: En infusionsrelateret reaktion blev i kliniske studier defineret som enhver bivirkning, der forekom under en infusion eller inden for 1 time efter en infusion.
English: Immunogenicity Antibodies to infliximab were detected in 4 (7.7%) patients through week 54.
Danish: Immunogenicitet Antistoffer over for infliximab blev påvist hos 4 (7,7 %) patienter i uge 54.
English: Thereafter, all subjects continued on infliximab every 6 weeks to week 96.
Danish: Derefter fortsatte alle patienterne på infliximab hver 6. uge til uge 96.
English: If these medicines or treatments do not work well enough, you will be given Remicade to reduce the signs and symptoms of your disease.
Danish: Hvis disse lægemidler eller behandlinger ikke virker godt nok, vil du få Remicade for at reducere tegn og symptomer på din sygdom.
English: Patients who developed antibodies to infliximab were more likely (approximately 2-3 fold) to develop infusion-related reactions.
Danish: Patienter, som udviklede antistoffer over for infliximab, havde større sandsynlighed (cirka 2-3 gange) for at udvikle infusionsrelaterede reaktioner.
English: During clinical studies of Remicade across all approved indications the incidence of lymphoma in Remicade-treated patients was higher than expected in the general population, but the occurrence of lymphoma was rare.
Danish: Under kliniske studier med Remicade over alle godkendte indikationer var forekomsten af lymfom hos Remicade-behandlede patienter højere end forventet i den generelle befolkningsgruppe, men forekomsten af lymfom var sjælden.
English: Infliximab + AZA Combination Therapy
Danish: Infliximab + AZA Kombinationsterapi
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 TNF and interferon.
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 TNF og interferon.
English: The pharmacokinetics of infliximab in elderly patients has not been studied.
Danish: Farmakokinetikken for infliximab hos ældre patienter er ikke blevet undersøgt.
English: Remicade works by selectively attaching to TNF alpha and blocking its action.
Danish: Remicade virker ved selektivt at binde sig til TNF alfa og blokere dets virkning.
English: Of the patients who required a dose titration, 80% achieved clinical response and the majority (64%) of these required only one adjustment of 1.5 mg/kg.
Danish: Af de patienter som behøvede dosisjustering opnåede 80 % klinisk respons og størstedelen af disse (64 %) behøvede kun en justering med 1,5 mg/kg.
English: In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of Remicade, 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 Remicade, eller justering af samtidig behandling.
English: Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands
Danish: Janssen Biologics B.V., Einsteinweg 101 Leiden 2333 CB, Holland
English: Operations or dental procedures
Danish: Operationer eller tandindgreb
English: Antibodies to infliximab cannot always be detected in serum samples.
Danish: Antistoffer over for infliximab kan ikke altid påvises i serumprøver.
English: Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 1.2 micrometre or less).
Danish: Anvend kun et infusionssæt med et in-line, sterilt, ikke-pyrogent, minimalt proteinbindende filter (porestørrelse 1,2 mikrometer eller derunder).
English: Patients who have had their dose interval shortened to less than 8 weeks may be at greater risk for adverse reactions.
Danish: Patienter, for hvem doseringsintervallet er afkortet til under 8 uger, kan have større risiko for bivirkninger.
English: • If you received Remicade while you were pregnant, your baby may also be at higher risk for getting an infection with live vaccines for up to six months after birth.
Danish: • Hvis du har fået Remicade, mens du var gravid, kan dit barn også have en større risiko for at få en infektion med levende vacciner i op til 6 måneder efter fødslen.
English: • Some patients receiving Remicade have developed serious liver problems.
Danish: • Nogle patienter, der får Remicade, har udviklet alvorlige leverproblemer.
English: Table 4 Effects on ACRn, Structural Joint Damage and Physical Function at week 54, ASPIRE Infliximab + MTX Placebo + MTX 3 mg/kg 6 mg/kg Combined
Danish: Tabel 4 Effekter på ACRn, strukturel ledskade og fysisk funktion ved uge 54, ASPIRE Infliximab + MTX Placebo + MTX 3 mg/kg 6 mg/kg Kombineret
English: • A type of blood cancer (lymphoma)
Danish: • En type blodkræft (lymfom)
English: Concurrent use of stable doses of conventional therapies was permitted, and 92% of patients continued to receive these therapies.
Danish: Samtidig brug af stabile doser af konventionel behandling var tilladt, og 92 % af patienterne fortsatte brugen af disse behandlinger.
English: • These infections may be serious and include tuberculosis, infections caused by viruses, fungi, bacteria, or other organisms in the environment and sepsis that may be life-threatening.
Danish: • Disse infektioner kan være alvorlige og indbefatter tuberkulose, infektioner forårsaget af virus, svampe, bakterier eller andre organismer i miljøet samt blodforgiftning, som kan være livstruende.
English: In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 patients-years (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: Re-administration across indications
Danish: Fornyet indgift på tværs af indikationer
English: • If you received Remicade during your pregnancy, your baby may have a higher risk for getting an infection.
Danish: • Hvis du fik Remicade under graviditeten, kan dit barn have en øget risiko for at få en infektion.
English: Rare: Complement factor abnormal.
Danish: Sjælden: Komplementfaktorabnormitet.
English: Structural joint damage (erosions and joint space narrowing) in both hands and feet was measured by the change from baseline in the total van der Heijde-modified Sharp score (0-440).
Danish: Strukturel ledskade (erosioner og forsnævring af ledspalte) i begge hænder og fødder blev målt som ændringen fra baseline i total van der Heijde-modified Sharp score (0-440).
English: • Children and adults taking Remicade may have an increased risk of developing lymphoma or another cancer.
Danish: • Børn og voksne i behandling med Remicade kan have en øget risiko for at udvikle lymfom eller anden form for kræft.
English: HAQ change from baseline over time e (patients evaluated) Mean ± SD
Danish: HAQ ændring fra baseline over tiden e (patienter evalueret) Gennemsnit  SD
English: For results see Table 6.
Danish: Resultaterne ses i tabel 6.
English: Indication Number of patients
Danish: Antal patienter
English: Histological evaluation of colonic biopsies, obtained before and 4 weeks after administration of infliximab, revealed a substantial reduction in detectable TNF.
Danish: Histologisk evaluering af biopsier fra colon, som er udtaget før og 4 uger efter indgivelse af infliximab, viste en betydelig reduktion i påviseligt TNF.
English: In a fertility and general reproductive function study, the number of pregnant mice was reduced following administration of the same analogous antibody.
Danish: I et fertilitets- og generel reproduktionsfunktionsstudie var antallet af drægtige mus reduceret efter indgift af det samme analoge antistof.
English: Since the possibility of increased risk of cancer development in patients with newly diagnosed dysplasia treated with Remicade 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 Remicade ikke er vist, bør risiko og gavn af fortsat behandling for de individuelle patienter nøje overvejes af lægen.
English: If these medicines do not work well enough, you will be given Remicade which you will take in combination with another medicine called methotrexate to:
Danish: Hvis disse lægemidler ikke virker godt nok, vil du få Remicade, som du skal tage sammen med et andet lægemiddel, der hedder methotrexat, for at:
English: At the last evaluation, 57% of infliximab-treated patients remained anti-dsDNA positive.
Danish: Ved den sidste vurdering var 57 % af infliximab-behandlede patienter fortsat anti-dsDNA positive.
English: Use of antituberculosis therapy should also be considered before the initiation of Remicade in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Danish: Anvendelsen af anti-tuberkulosebehandling bør også overvejes før initieringen af Remicade hos patienter med en tidligere sygdomshistorie med latent eller aktiv tuberkulose, hos hvem et passende behandlingsprogram ikke kan bekræftes.
English: Appropriate empiric antifungal therapy should be considered while a diagnostic workup is being performed taking into account both the risk for severe fungal infection and the risks of antifungal therapy.
Danish: Relevant empirisk antifungal behandling bør overvejes under diagnosticeringen, idet der både tages hensyn til risikoen ved alvorlig svampeinfektion og risikoen ved antifungal behandling.
English: There was one reported malignancy amongst 77 control patients (median duration of follow-up 0.8 years; incidence 1.3% [95% CI 0.03%-7.0%]).
Danish: Der var en rapporteret malign sygdom blandt 77 kontrolpatienter (median opfølgningsperiode 0,8 år; incidence 1.3 % [95 % CI 0,03 %-7,0 %]).
English: Week 98 data for IMPACT includes combined placebo crossover and infliximab patients who entered the open-label extension.
Danish: Uge 98 data for IMPACT inkluderer kombineret placebo cross-over og infliximab-patienter, der deltog i den åbne undersøgelse.
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 Remicade
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 Remicade.
English: The educational programme consists of a patient reminder card to be held by the patient.
Danish: Uddannelsesprogrammet består af et patientinformationskort, som patienten skal have på sig.
English: 6 weeks after your 1
Danish: 6 uger efter din 1. dosis
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: Acute infusion reactions including anaphylactic reactions may develop during (within seconds) or within a few hours following infusion.
Danish: Akutte infusionsreaktioner inklusive anafylaktiske reaktioner kan opstå under (inden for sekunder) eller få timer efter infusionen.
English: Single intravenous infusions of 1, 3, 5, 10 or 20 mg/kg of infliximab yielded dose proportional increases in the maximum serum concentration (Cmax) and area under the concentration-time curve (AUC).
Danish: Enkelte intravenøse infusioner på 1, 3, 5, 10 eller 20 mg/kg infliximab udviste dosis-proportionale stigninger i den maksimale serumkoncentration (Cmax) samt området under koncentrationstidskurven (AUC).
English: • Some patients treated with infliximab have developed certain kinds of skin cancer.
Danish: • Nogle patienter, der er blevet behandlet med infliximab, har udviklet visse former for hudkræft.
English: In this situation, do not return to refrigerated storage again.
Danish: I denne situation må det ikke sættes tilbage i køleskab.
English: At 102 weeks there were 49 subjects still on infliximab treatment and among those, 30 (61%) were BASDAI 50 responders.
Danish: I 102. uge var 49 patienter stadig på infliximabbehandling, og blandt disse var 30 (61 %) BASDAI 50 responders.
English: • Tell your doctor before you are given Remicade if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
Danish: • Fortæl din læge, før du får Remicade, hvis du har eller nogensinde har haft lymfom (en type blodkræft) eller enhver anden form for kræft.
English: A reduction in signs and symptoms was defined to be at least a 20% improvement (ACR20) in both tender and swollen joint counts, and in 3 of the following 5 criteria: (1) evaluator's global assessment, (2) patient's global assessment, (3) functional/disability measure, (4) visual analogue pain scale and (5) erythrocyte sedimentation rate or C-reactive protein.
Danish: Et fald i tegn og symptomer var defineret som værende mindst en 20 % forbedring (ACR20) i antallet af både ømme og hævede led og i 3 af de følgende 5 kriterier: (1) Evaluators samlede vurdering, (2) patientens samlede vurdering, (3) funktions/handicap mål, (4) visuel analog smerteskala og (5) erytrocytsedimentationshastighed eller C-reaktiv protein.
English: Since no preservative is present, it is recommended that the administration of the solution for infusion is to be started as soon as possible and within 3 hours of reconstitution and dilution.
Danish: Da der ikke er anvendt konserveringsmiddel, anbefales det, at indgivelsen af infusionsvæsken begyndes så hurtigt som muligt og inden for 3 timer efter rekonstitution og fortynding.
English: greater values indicate more joint damage.
Danish: højere værdier indikerer mere ledskade.
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 infliximabbehandlede personer var signifikant PASI 50 respons tydelig ved det første besøg (uge 2) og PASI 75 respons ved det andet besøg (uge 6).
English: Due to its inhibition of TNF, infliximab administered during pregnancy could affect normal immune responses in the newborn.
Danish: På grund af hæmningen af TNF kan infliximab indgivet under graviditet påvirke det normale immunrespons hos den nyfødte.
English: Children may receive some vaccines during treatment with Remicade but should not receive live vaccines while using Remicade.
Danish: Børn kan få visse vacciner under behandlingen med Remicade, men må ikke få levende vacciner, mens de får Remicade.
English: Remicade may have a minor influence on the ability to drive and use machines.
Danish: Remicade påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Patients who were randomised to the placebo maintenance group and then later crossed over to infliximab are included in the infliximab group in the ALT analysis.
Danish: Patienter, som var randomiseret til placebo-vedligeholdelsesgruppen og senere blev krydset over til infliximab, er inkluderet i infliximab-gruppen i ALAT-analysen.
English: Cases of TB have been reported in patients treated with Remicade, even in patients who have already been treated with medicines for TB.
Danish: Tilfælde af TB har været rapporteret hos patienter i behandling med Remicade, også hos patienter, der allerede har været i behandling med medicin mod TB.
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: Higher degrees of clinical response (ACR50 and ACR70) were observed in all infliximab groups at 30 and 54 weeks compared with methotrexate alone.
Danish: Højere grader af klinisk respons (ACR50 og ACR70) blev set i alle infliximab-grupper ved 30 og 54 uger sammenlignet med methotrexat alene.