FrancophonIA/ELRC3.0 huggingface dataset:
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 coloncarcinom (for eksempel patienter med langvarig colitis ulcerosa eller primær sklerotisk cholangitis), eller som tidligere har haft dysplasi eller coloncarcinom, bør screenes for dysplasi med reglmæssige intervaller før behandling og under deres sygdomsforløb.
English: Table 6 Percent of patients achieving corticosteroid-free clinical remission at Week 26, SONIC AZA Monotherapy
Danish: Tabel 6 Procent af patienter, som opnåede kortikosteroidfri klinisk remission i uge 26, SONIC
English: • It is important that you tell your baby's doctors and other healthcare professionals about your Inflectra use before your baby is given any vaccine.
Danish: • Det er vigtigt, at du fortæller dit barns læge og andet sundhedspersonale, at du får Inflectra, før barnet bliver vaccineret.
English: >40 weeks
Danish: > 40 uger
English: • Low blood counts, including a severely decreased number of white blood cells
Danish: • Lavt antal blodceller, herunder svært nedsat antal hvide blodlegemer
English: Psoriatic arthritis, ankylosing spondylitis (Bechterew's disease), psoriasis, ulcerative colitis and Crohn's disease
Danish: Psoriasisarthritis, ankyloserende spondylitis (Bechterews sygdom), psoriasis, colitis ulcerosa og Crohns sygdom
English: In this study, there were more patients in the 12 to 17 year age group than in the 6 to 11 year age group (45/60 [75.0%]) vs.15/60 [25.0%]).
Danish: I dette studie var der flere patienter i gruppen 12 til 17 år end i gruppen 6 til 11 år (45/60 [75,0%]) vs. 15/60 [25,0%]).
English: Concurrent administration of TNF-alpha inhibitor and abatacept
Danish: Samtidig administration af TNF-alfahæmmer og abatacept
English: Inflectra works by selectively attaching to TNF alpha (tumour necrosis factor alpha) and blocking its action.
Danish: Inflectra virker ved at binde sig selektivt til TNF-alfa (tumornekrosefaktor alfa) og blokere dets virkning.
English: and headache.
Danish: Hovedpine.
English: ACR 20 response* ACR 50 response* ACR 70 response* PASI response (% of patients)b
Danish: ACR 20 respons* 5(10%) ACR 50 respons* 0(0%) ACR 70 respons* 0(0%) PASI respons (% af patienter)
English: There is limited safety experience of infliximab treatment in patients who have undergone surgical procedures, including arthroplasty.
Danish: Der er begrænset erfaring med sikkerheden af infliximab-behandling hos patienter, som har gennemgået kirurgiske indgreb inklusive artroplastik.
English: Elevations of aminotransferases were observed (ALT more common than AST) in a greater proportion of patients receiving infliximab than in controls, both when infliximab 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) hos en større del af patienter, der fik infliximab, end hos kontrolpersoner, både når infliximab blev givet i monoterapi, og når det blev brugt i kombination med andre immunsuppressive stoffer.
English: If serious reactions occur, symptomatic treatment must be given and further infliximab infusions must not be administered (see section 4.8).
Danish: Hvis alvorlige reaktioner opstår, skal symptomatisk behandling gives, og der må ikke gives yderligere infliximabinfusioner (se pkt.
English: Population pharmacokinetic analysis based on data obtained from patients with ulcerative colitis (N=60), Crohn's disease (N=112), juvenile rheumatoid arthritis (N=117) and Kawasaki disease (N=16) with an overall age range from 2 months to 17 years indicated that exposure to infliximab was dependent on body weight in a non-linear way.
Danish: En farmakokinetisk populationsanalyse baseret på data fra patienter med colitis ulcerosa (N=60), Crohns sygdom (N=112), juvenil reumatoid arthritis (N=117) og Kawasakis sygdom (N=16) med et overordnet aldersinterval fra 2 måneder til 17 år indikerede, at eksponering for infliximab var afhængig af legemsvægt på en ikke-lineær måde.
English: Before treatment with Inflectra
Danish: Før behandling med Inflectra
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: d p = 0.030 and <0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs.
Danish: d p = 0,030 og < 0,001 for henholdsvis 3 mg/kg og 6 mg/kg behandlingsgruppen mod placebo + MTX.
English: A patient who requires surgery while on infliximab should be closely monitored for infections, and appropriate actions should be taken.
Danish: En patient, som kræver operation under infliximabbehandling, bør følges nøje for infektioner, og passende forholdsregler bør tages.
English: After in utero exposure to infliximab, infants may be at increased risk of infection, including serious disseminated infection that can become fatal.
Danish: Spædbørn, der har været eksponeret for infliximab i uterus, kan have en øget risiko for infektioner, herunder svær dissemineret infektion, som kan blive letal.
English: Repeated administration of infliximab (5 mg/kg at 0, 2 and 6 weeks in fistulising Crohn's disease, 3 or 10 mg/kg every 4 or 8 weeks in rheumatoid arthritis) resulted in a slight accumulation of infliximab in serum after the second dose.
Danish: Gentagen administration af infliximab (5 mg/kg ved 0, 2 og 6 uger i fistulerende Crohns sygdom, 3 eller 10 mg/kg hver 4. eller 8. uge i reumatoid arthritis) resulterede i en let akkumulering af infliximab i serum efter den anden dosis.
English: Infusion reactions occurred in 35% of patients with juvenile rheumatoid arthritis receiving 3 mg/kg compared with 17.5% of patients receiving 6 mg/kg.
Danish: Der opstod infusionsreaktioner hos 35% af patienterne med juvenil reumatoid arthrithis, som fik 3 mg/kg sammenlignet med 17,5% af patienterne som fik 6 mg/kg.
English: In a subset of 90 adult patients with rheumatoid arthritis from the ASPIRE study a similar proportion of patients in each treatment group (methotrexate plus: placebo [n = 17], 3 mg/kg [n = 27] or 6 mg/kg infliximab [n = 46]) mounted an effective two-fold increase in titres to a polyvalent pneumococcal vaccine, indicating that infliximab did not interfere with T-cell independent humoral immune responses.
Danish: I en undergruppe med 90 voksne patienter med reumatoid arthritis fra ASPIRE-studiet kom en tilsvarende andel af patienterne i hver behandlingsgruppe (methotrexat plus: placebo [n=17], 3 mg/kg [n=27] eller 6 mg/kg infliximab [n=46]) op på en effektiv fordobling i titer med en polyvalent pneumokokvaccine, som indikerer, at infliximab ikke påvirkede det T-celle uafhængige humorale immunrespons.
English: The solution has to be gently swirled by rotating the vial to dissolve the powder.
Danish: Opløsningen blandes forsigtigt ved at vende hætteglasset for at opløse pulveret.
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), acute generalised exanthematous pustulosis (AGEP), lichenoid reactions.
Danish: Toksisk epidermal nekrolyse, Stevens-Johnsons syndrom, erythema multiforme, furunkulose, lineær IgA bulløs dermatose (LABD), akut generaliseret eksantematøs pustulose (AGEP), lichenoide reaktioner.
English: Use of TNF-blocking agents, including infliximab, has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis, and peripheral demyelinating disorders, including Guillain-Barré syndrome.
Danish: Brug af TNF-blokerende midler, inklusive infliximab har været forbundet med tilfælde af frembrud af eller forværring af kliniske symptomer og/eller radiografiske tegn på demyeliniseringssygdomme i centralnervesystemet, inklusive dissemineret sklerose og perifere demyeliniseringssygdomme, inklusive Guillain-Barré syndrom.
English: Events (some fatal) of myocardial ischaemia/infarction and arrhythmia have been reported, some in close temporal association with infusion of infliximab, cerebrovascular accidents have also been reported in close temporal association with infusion of infliximab.
Danish: Hændelser (nogle letale) af myokardieiskæmi/-infarkt og arytmi er også set; nogle af hændelserne forekom i tæt tidsmæssig forbindelse med infusionen af infliximab; der er også set cerebrovaskulære hændelser i tæt tidsmæssig forbindelse med infusion af infliximab.
English: The solution must not be used if opaque particles, discolouration, or other foreign particles are present.
Danish: Opløsningen må ikke anvendes, hvis den indeholder uigennemsigtige partikler, er misfarvet eller indeholder andre fremmedlegemer.
English: Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNFα-blocking agent, etanercept, with no added clinical benefit compared to etanercept alone.
Danish: Der blev observeret alvorlige infektioner og neutropeni i kliniske studier ved samtidig anvendelse af anakinra og et andet TNFα-blokerende middel, etanercept, uden nogen øget klinisk fordel sammenlignet med etanercept indgivet alene.
English: Of the 22 subjects that had fistulas at baseline, 63.6% (14/22), 59.1% (13/22) and 68.2% (15/22) were in complete fistula response at week 10, 30 and 54, respectively, in the combined q8 weeks and q12 weeks maintenance groups.
Danish: Af de 22 personer som havde fistler ved baseline, var henholdsvis 63,6% (14/22), 59,1% (13/22) og 68,2% (15/22) i fuldstændig fistelrespons i uge 10, 30 og 54 i de kombinerede 8-ugers og 12-ugers vedligeholdelsesgrupper.
English: Limited experience from re-treatment with one single infliximab dose in psoriasis after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen (see section 5.1).
Danish: Begrænset erfaring fra fornyet administration med en enkelt infliximab dosis ved psoriasis efter et interval på 20 uger tyder på nedsat virkning og en højere incidens af lette til moderate infusionsreaktioner sammenlignet med det initiale induktionsregime (se pkt.
English: • Store in a refrigerator (2 °C - 8 °C).
Danish: • Opbevares i køleskab (2°C - 8°C).
English: • Tell your doctor before you are given Inflectra if you have or have ever had a problem that affects your nervous system.
Danish: • Før du får Inflectra, skal du fortælle det til din læge, hvis du har eller nogensinde har haft en lidelse, som påvirker dit nervesystem.
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: • You should avoid getting pregnant when you are being treated with Inflectra and for 6 months after you stop being treated with it.
Danish: • Du skal undgå at blive gravid, mens du er i behandling med Inflectra, og i mindst 6 måneder efter du er stoppet med behandlingen.
English: In Crohn's disease patients who received maintenance treatment, antibodies to infliximab occurred overall in 3.3% of patients receiving immunosuppressants and in 13.3% of patients not receiving immunosuppressants.
Danish: Blandt patienter med Crohns sygdom, der fik vedligeholdelsesbehandling, forekom antistoffer mod infliximab hos i alt 3,3% af de patienter, som fik immunsuppressiva, og hos 13,3% af de patienter, som ikke fik immunsuppressiva.
English: For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of infliximab treatment should be carefully considered before initiation of infliximab therapy.
Danish: Hos patienter, der har boet i eller rejst til områder, hvor invasive svampeinfektioner såsom histoplasmose, kokcidioidomykose eller blastomykose er endemiske, skal fordele og risici ved infliximab-behandling overvejes omhyggeligt, før Inflectra-behandling initieres.
English: Among patients classified as non-responders at week 2, 32% (26/81) in the placebo maintenance group and 42% (68/163) in the infliximab group achieved clinical response by week 6.
Danish: Blandt patienter klassificeret som non-responderende ved uge 2, opnåede 32% (26/81) i placebovedligeholdelsesgruppen og 42% (68/163) i infliximab-gruppen klinisk respons ved uge 6.
English: Some cases of active tuberculosis have been reported in patients treated with infliximab during and after treatment for latent tuberculosis.
Danish: Der er rapporteret nogle tilfælde af aktiv tuberkulose hos patienter behandlet med infliximab, under og efter behandlingen for latent tuberkulose.
English: Inflectra treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis.
Danish: Behandling med Inflectra skal initieres og holdes under opsyn af kvalificerede læger med erfaring i diagnostik og behandling af reumatoid arthritis, inflammatoriske tarmsygdomme, ankyloserende spondylitis, psoriasis arthritis eller psoriasis.
English: The ASPIRE study evaluated responses at 54 weeks in 1,004 methotrexate naive patients with early (≤ 3 years disease duration, median 0.6 years) active rheumatoid arthritis (median swollen and tender joint count of 19 and 31, respectively).
Danish: ASPIRE studiet evaluerede respons ved uge 54 hos 1.004 methotrexat naive patienter med tidlig (≤ 3 års sygdomsvarighed, median 0,6 år) aktiv reumatoid arthritis (median antallet af hævede og ømme led var henholdsvis 19 og 31).
English: • Narrowed airway in the lungs, causing difficulty breathing
Danish: • Forsnævrede luftveje i lungerne, der giver vejrtrækningsbesvær
English: If stored refrigerated after reconstitution and dilution, the infusion solution must be allowed to equilibrate at room temperature to 25 °C for 3 hours prior to Step 4 (infusion).
Danish: Hvis infusionsopløsningen opbevares i køleskab efter rekonstitution og fortynding, skal den stå ved stuetemperatur på 25C i 3 timer inden trin 4 (infusion).
English: Inflectra is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Danish: Inflectra er indiceret til behandling af svær, aktiv ankyloserende spondylitis hos voksne patienter, som har responderet utilstrækkeligt på konventionel behandling.
English: Re-administration for psoriasis
Danish: Fornyet administration ved psoriasis
English: Caution should be exercised when considering the use of infliximab in patients with chronic infection or a history of recurrent infections, including concomitant immunosuppressive therapy.
Danish: Forsigtighed bør udvises, når brug af infliximab overvejes hos patienter med kronisk infektion eller med en sygdomshistorie med tilbagevendende infektioner, inklusive samtidig behandling med immunsuppressive lægemidler.
English: b a A ≥ 50% reduction from baseline in the number of draining fistulas over a period of ≥ 4 weeks.
Danish: Fistelrespons (%) Komplet fistelrespons (%) a A ≥ 50% reduktion fra baseline i antallet af drænede fistler over en periode på ≥ 4 uger.
English: • Some patients who have received TNF-blockers, including infliximab have developed a rare type of cancer called hepatosplenic T-cell lymphoma.
Danish: • Nogle patienter, som har fået TNF-blokkere, herunder infliximab, har udviklet en sjælden kræftform kaldet hepatosplenisk T-celle-lymfom.
English: Subjects randomised Percentage ACR improvement Mean ± SD
Danish: Procentvis ACR forbedring
English: • Other skin problems such as erythema multiforme, blisters and peeling skin, or boils
Danish: • Andre hudproblemer såsom erythema multiforme, blærer og afskalning af huden eller bylder
English: After reconstitution and dilution
Danish: Efter rekonstitution og fortynding:
English: The primary endpoint was the proportion of patients who experienced a clinical response, defined as a decrease in CDAI by ≥ 70 points from baseline at the 4-week evaluation and without an increase in the use of medicinal products or surgery for Crohn's disease.
Danish: Det primære endepunkt var andelen af patienter, der oplevede en klinisk virkning, bestemt som en nedgang i CDAI på ≥ 70 point fra baseline ved 4-ugers evalueringen og uden stigning i brugen af lægemidler eller kirurgiske indgreb for Crohns sygdom.
English: N/A 139 N/A 53.0 N/A 4.4% N/A 1.5%
Danish: N/A 4,4% N/A 1,5%
English: Inflectra contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Danish: Inflectra indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natriumfrit.
English: Eighty-nine percent (50/56) of patients who lost clinical response on infliximab 5 mg/kg maintenance therapy after week 14 responded to treatment with infliximab 10 mg/kg.
Danish: 89 procent (50/56) af patienterne, der mistede klinisk respons på infliximab 5 mg/kg vedligeholdelsesbehandling efter uge 14, responderede på behandling med infliximab 10 mg/kg.
English: • You should receive recommended vaccinations before starting Inflectra treatment.
Danish: • Du skal have de anbefalede vaccinationer, før du starter behandling med Inflectra.
English: In clinical studies using single and multiple infliximab doses ranging from 1 to 20 mg/kg, antibodies to infliximab were detected in 14% of patients with any immunosuppressant therapy, and in 24% of patients without immunosuppressant therapy.
Danish: I kliniske studier med en eller flere infliximab doser i intervallet fra 1 til 20 mg/kg, udvikledes antistoffer mod infliximab hos 14% af patienter, der fik en hvilken som helst immunsupprimerende behandling, og hos 24% af patienter uden immunsupprimerende behandling.
English: Significantly fewer colectomies occurred within 3 months of study infusion in patients who received a single dose of 5 mg/kg infliximab compared to patients who received placebo (29.2% vs. 66.7% respectively, p=0.017).
Danish: Der forekom signifikant færre kolektomier indenfor 3 måneder fra studieinfusion hos patienter, der fik en enkelt dosis 5 mg/kg infliximab sammenlignet med patienter, der fik placebo (hhv. 29,2% versus 66,7%, p=0,017).
English: Of infliximab-treated patients who had an infusion reaction during the induction period, through week 6, 27% experienced an infusion reaction during the maintenance period, week 7 through week 54.
Danish: Af de infliximab-behandlede patienter, som fik en infusionsreaktion under induktionsfasen til og med uge 6, fik 27% en infusionsreaktion i vedligeholdelsesfasen uge 7 til og med uge 54.
English: In clinical studies 36% of infliximab-treated patients were treated for infections compared with 25% of placebo-treated patients.
Danish: I kliniske studier blev 36% af infliximab-behandlede patienter behandlet for infektioner sammenlignet med 25% af placebobehandlede patienter.
English: Inflectra contains sodium
Danish: Inflectra indeholder natrium
English: Concurrent use of stable doses of oral corticosteroids (≤10 mg/day) and/or NSAIDs was permitted, and folate supplementation was given.
Danish: Samtidig anvendelse af stabile doser af orale kortikosteroider (≤ 10 mg/dag) og/eller NSAIDs var tilladt, og folatsupplement blev givet.
English: • That treatment with Inflectra may increase the risks of serious infections/sepsis, opportunistic infections, tuberculosis, hepatitis B reactivation, and BCG breakthrough in infants with in utero exposure to infliximab, and when to seek attention from a HCP
Danish: • Information om at behandling med Inflectra kan øge risikoen for alvorlige infektioner/sepsis, opportunistiske infektioner, tuberkulose, reaktivering af hepatitis B og BCGgennembrudsinfektion hos spædbørn, der i uterus er blevet eksponeret for infliximab, samt information om, hvornår patienten skal søge hjælp hos en sundhedsperson.
English: Inflectra is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: Inflectra er dog fortyndet i en natriumchloridopløsning 9 mg/ml (0,9%) til infusion.
English: Change from baseline in total van der Heijde-modified Sharp score b
Danish: Gennemsnit ± SD Ændring fra baseline i total van der Heijde modificeret Sharp score
English: • Some patients receiving infliximab have developed symptoms of an immune system disorder called lupus.
Danish: • Nogle patienter, som får infliximab, har udviklet symptomer på en sygdom i immunsystemet kaldet lupus.
English: Date of Inflectra therapy initiation:
Danish: Dato for start på Inflectra-behandling:
English: In the first clinical study (IMPACT), efficacy and safety of infliximab were studied in 104 patients with active polyarticular psoriatic arthritis.
Danish: I det første kliniske studie (IMPACT) blev virkning og sikkerhed af infliximab undersøgt hos 104 patienter med aktiv polyartikulær psoriasis arthritis.
English: • Some women being treated for rheumatoid arthritis with infliximab have developed cervical cancer.
Danish: • Nogle kvinder, der er blevet behandlet for reumatoid artrit med infliximab, har udviklet livmoderhalskræft.
English: The dilution can be accomplished by withdrawing a volume of the sodium chloride 9 mg/mL (0.9%) solution for infusion from the 250-mL glass bottle or infusion bag equal to the volume of reconstituted Inflectra.
Danish: Fortyndingen kan opnås ved at udtrække et volumen af natriumchlorid 9 mg/ml (0,9%) infusionsvæske fra 250 ml glasflasken eller infusionsposen svarende til voluminet af det rekonstituerede Inflectra.
English: All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g. persistent cough, wasting/weight loss, low-grade fever) appear during or after infliximab treatment.
Danish: Alle patienter skal informeres om at søge læge, hvis sygdomstegn/symptomer, der tyder på tuberkulose (vedvarende hoste, skranten/vægttab, let feber), forekommer under eller efter infliximabbehandling.
English: Investigations Uncommon:
Danish: Undersøgelser Ikke almindelig: Sjælden:
English: For patients receiving corticosteroids at baseline, the proportion of patients in remission and not receiving corticosteroids at week 54 was 38.5% (5/13) for the q8 week and 0% (0/13) for the q12 week maintenance treatment group.
Danish: For patienter, der fik kortikosteroider ved baseline, var andelen af patienter i remission, og som ikke fik kortikosteroider ved uge 54, 38,5% (5/13) for 8-ugers vedligeholdelsesbehandlingsgruppen og 0% (0/13) for 12-ugers vedligeholdelsesbehandlingsgruppen.
English: • Worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
Danish: • Forværring af en sygdom, der hedder dermatomyositis (muskelsvaghed med hududslæt som følgetilstand)
English: Sustained response (clinical response at both week 8 and week 30)a
Danish: Vedvarende respons (klinisk respons både i uge 8 og uge 30)
English: Under aseptic conditions, each Inflectra vial should be reconstituted with 10 mL of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle.
Danish: Under aseptiske forhold rekonstitueres hvert Inflectra-hætteglas med 10 ml vand til injektionsvæsker ved hjælp af en sprøjte med en gauge 21 (0,8 mm) kanyle eller med en mindre kanyle.