FrancophonIA/ELRC3.0 huggingface dataset:
English: No major age- or weight-related differences in clearance or volume of distribution were observed in rheumatoid arthritis patients.
Danish: Ingen større alders- eller vægtrelaterede forskelle i elimination eller fordelingsvolumen sås hos patienter med reumatoid arthritis.
English: Remicade is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Danish: Remicade er indiceret til behandling af aktiv og progressiv psoriasis arthritis hos voksne patienter, hvor respons på tidligere DMARD-behandling har været utilstrækkelig.
English: If you have Crohn's disease you will first be given other medicines.
Danish: Hvis du lider af Crohns sygdom, vil du først få andre lægemidler.
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: Calculate the total volume of reconstituted Remicade solution required.
Danish: Beregn det samlede påkrævede volumen rekonstitueret Remicade-koncentrat.
English: • treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
Danish: • behandling af fistulerende, aktiv Crohns sygdom hos voksne patienter, som ikke har responderet på trods af en fuldstændig og adækvat behandlingsperiode med konventionel behandling (inklusive antibiotika, drænage og immunsuppressiv behandling).
English: Currently available data are described in sections 4.8 and 5.2 but no recommendation on a posology can be made.
Danish: 4.8 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Gently swirl the solution by rotating the vial to dissolve the lyophilised powder.
Danish: Bland forsigtigt koncentratet ved at vende hætteglasset for at opløse det lyofiliserede pulver.
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 vs.15/60).
Danish: I dette studie var der flere patienter i gruppen 12 til 17 år end i gruppen 6 til 11 år (45/60 versus 15/60).
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 Remicade [n = 46]) mounted an effective two-fold increase in titers to a polyvalent pneumococcal vaccine, indicating that Remicade 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 Remicade [n = 46]) op på en effektiv fordobling i titer med en polyvalent pneumokokvaccine, som indikerer, at Remicade ikke påvirkede det T-celle uafhængige humorale immunrespons.
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: 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 demyeliniseringsforstyrrelser i centralnervesystemet, inklusive dissemineret sklerose og perifere demyeliniseringsforstyrrelser, inklusive Guillain-Barré syndrom.
English: Insert the syringe needle into the vial through the centre of the rubber stopper and direct the stream of water for injections to the glass wall of the vial.
Danish: Indsæt sprøjtekanylen i hætteglasset gennem midten af gummiproppen og ret injektionsvæskestrømmen mod glasvæggen i hætteglasset.
English: In clinical studies, mild or moderate elevations of ALT and AST have been observed in patients receiving Remicade without progression to severe hepatic injury.
Danish: I kliniske studier er let til moderate stigninger i ALAT og ASAT set hos patienter, der fik Remicade, uden progression til alvorlig leverskade.
English: • Tell your doctor before you are given Remicade if you are a carrier of hepatitis B or have ever had it.
Danish: • Fortæl din læge, før du får Remicade, hvis du er bærer af hepatitis B, eller hvis du nogensinde har haft det.
English: Endoscopic studies of intestinal mucosa have shown evidence of mucosal healing in infliximab-treated patients.
Danish: Endoskopiske studier af tarm-mucosa har vist tegn på heling af mucosa hos infliximab-behandlede patienter.
English: There were 95 subjects from group 2 who continued on 5 mg/kg every 6 weeks.
Danish: Der var 95 patienter fra gruppe 2, som fortsatte på 5 mg/kg hver 6. uge.
English: • Children should receive recommended vaccinations before starting Remicade treatment.
Danish: • Børn skal have de anbefalede vaccinationer, før behandling med Remicade påbegyndes.
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: 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: If these medicines do not work well enough, you will be given Remicade to:
Danish: Hvis disse lægemidler ikke virker godt nok, vil du få Remicade for at:
English: What Remicade is and what it is used for What you need to know before you use Remicade How Remicade will be given Possible side effects
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får Remicade Sådan får du Remicade Bivirkninger
English: • Do not use this medicine after the expiry date which is stated on the label and the carton after “EXP”.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned
English: Further doses
Danish: Efterfølgende doser
English: 19 weeks
Danish: 19 uger
English: For women taking Remicade including those over 60 years of age, your doctor may recommend regular screening for cervical cancer.
Danish: Lægen kan tilråde, at kvinder, der får Remicade, herunder kvinder over 60 år, bliver regelmæssigt screenet for livmoderhalskræft.
English: There is limited safety experience of Remicade treatment in patients who have undergone surgical procedures, including arthroplasty.
Danish: Der er begrænset erfaring med sikkerheden af Remicadebehandling hos patienter, som har gennemgået kirurgiske indgreb inklusive atroplastik.
English: There are insufficient data on the incidence of delayed hypersensitivity reactions after Remicade-free intervals of more than 1 year but limited data from clinical studies suggest an increased risk for delayed hypersensitivity with increasing Remicade-free interval (see section 4.4).
Danish: Der er utilstrækkelige resultater vedrørende forekomst af forsinkede overfølsomhedsreaktioner efter Remicade-fri perioder på mere end 1 år, men begrænsede resultater fra kliniske studier tyder på en øget risiko for overfølsomhed ved stigende Remicade-fri periode (se pkt.
English: • Talk to your doctor if you recently have had or are due to have a vaccine.
Danish: • Tal med din læge, hvis du lige er blevet eller har planlagt at blive vaccineret.
English: Upon removal from refrigerated storage, Remicade must not be returned to refrigerated storage.
Danish: Når Remicade er taget ud af køleskabet, må det ikke sættes tilbage på køl igen.
English: No dose recommendations can be made (see section 5.2).
Danish: Der kan ikke gives nogen anbefalinger vedrørende dosering (se pkt.
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 arthrit (median antallet af hævede og ømme led var henholdsvis 19 og 31).
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 effekt, 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: Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, ATTRACT infliximab
Danish: Tabel 3 Virkninger på ACR20, strukturel ledskade og fysisk funktionsevne ved uge 54, ATTRACT
English: Limited experience from re-treatment with one single Remicade 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 indgift med en enkelt Remicade dosis ved psoriasis efter et interval på 20 uger tyder på nedsat effekt og en højere incidens af lette til moderate infusionsreaktioner sammenlignet med det initiale induktionsregime (se pkt.
English: Caution should be exercised when considering the use of Remicade in patients with chronic infection or a history of recurrent infections, including concomitant immunosuppressive therapy.
Danish: Forsigtighed bør udvises, når brug af Remicade overvejes hos patienter med kronisk infektion eller med en sygdomshistorie med tilbagevendende infektioner, inklusive samtidig behandling med immunsuppressive lægemidler.
English: Remicade has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1).
Danish: Det er blevet påvist, at Remicade fremmer fysisk funktion hos patienter med psoriasis arthritis samt reducerer udviklingshastigheden af perifere ledskader målt med røntgen hos patienter med polyartikulære symmetriske undertyper af sygdommen (se pkt.
English: Concomitant stable doses of oral aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted.
Danish: Samtidig anvendelse af stabile doser af orale aminosalicylater, kortikosteroider og/eller immunmodulatorer var tilladt.
English: • Possible signs of cancer including but not limited to swelling of lymph nodes, weight loss, fever, unusual skin nodules, changes in moles or skin colouring, or unusual vaginal bleeding.
Danish: • Mulige tegn på kræft, inklusive men ikke begrænset til hævede lymfeknuder, vægttab, feber, usædvanlige knuder i huden, ændringer i modermærker eller hudfarven eller usædvanlig blødning fra skeden.
English: In case maintenance therapy is interrupted, and there is a need to restart treatment, use of a re-induction regimen is not recommended (see section 4.8).
Danish: Hvis vedligeholdelsesbehandling afbrydes, og der er behov for genstart af behandlingen, anbefales det ikke at gentage induktionsbehandlingen (se pkt.
English: Signs include changes in your vision, weakness in your arms or legs, numbness or tingling in any part of your body.
Danish: Tegn inkluderer synsændringer, muskelsvaghed i arme eller ben, følelsesløshed eller prikken et sted i kroppen.
English: Heart problems
Danish: Hjerteproblemer
English: • Pain.
Danish: • Smerter.
English: Infusion reactions following re-administration of Remicade A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and safety of long-term maintenance therapy versus re-treatment with an induction regimen of Remicade (maximum of four infusions at 0, 2, 6 and 14 weeks) following disease flare.
Danish: Infusionsrelaterede reaktioner efter fornyet indgift af Remicade Der var designet et klinisk studie med patienter med moderat til svær psoriasis for at undersøge effekt og sikkerhed af langtidsvedligeholdelsesbehandling i forhold til fornyet indgift med et induktionsregime med Remicade (højst 4 infusioner efter 0, 2, 6 og 14 uger) efter opblussen af sygdom.
English: Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions (see section 4.8).
Danish: Infliximab har været forbundet med akutte infusionsrelaterede reaktioner, omfattende anafylaktisk shock samt forsinkede overfølsomhedsreaktioner (se pkt.
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: • That treatment with Remicade 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 Remicade 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: Beginning at week 22, patients who initially responded to treatment and subsequently lost their response were eligible to cross over to active re-treatment every 8 weeks at a dose of infliximab 5 mg/kg higher than the dose to which they were originally randomised.
Danish: I begyndelsen af uge 22 blev patienter, der initialt responderede på behandling og efterfølgende mistede deres respons, kvalificeret til at krydse over til aktiv genbehandling hver 8. uge på en infliximab-dosis 5 mg/kg højere end den dosis, hvortil de oprindeligt blev randomiseret.
English: In clinical studies delayed hypersensitivity reactions have been uncommon and have occurred after Remicade-free intervals of less than 1 year.
Danish: I kliniske studier har forsinkede overfølsomhedsreaktioner været usædvanlige og er forekommet efter Remicade-fri perioder på mindre end 1 år.
English: The incidence of serious infections in Remicade-treated patients 65 years and older was greater than in those under 65 years of age.
Danish: Incidensen af alvorlige infektioner var højere hos Remicade-behandlede patienter på 65 år og derover end hos patienter under 65 år.
English: Your baby should not receive a ‘live vaccine', such as BCG (used to prevent tuberculosis) within 6 months after birth.
Danish: Dit barn må ikke få en ”levende vaccine”, fx BCG (bruges til at forebygge tuberkulose) inden for 6 måneder efter fødslen.
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 indgift 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: 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: Remicade 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 Remicade 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: Patients should be closely monitored and Remicade must not be continued in patients who develop new or worsening symptoms of heart failure (see sections 4.3 and 4.8).
Danish: Patienter bør følges nøje, og Remicade må ikke fortsættes hos patienter, som udvikler nye eller forværrede symptomer på hjerteinsufficiens (se pkt.
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: all infliximab doses given in combination with methotrexate and folate with some on corticosteroids and/or NSAIDs p < 0.001, for each infliximab treatment group vs. control greater values indicate more joint damage.
Danish: Alle infliximab doser er givet i kombination med methotrexat og folat samt eventuelt kortikosteroider og/eller NSAIDs p < 0,001, for hver infliximab-behandlingsgruppe versus kontrol
English: Administer the infusion solution over a period of not less than the infusion time recommended (see section 4.2).
Danish: Indgiv infusionsvæsken over en periode på ikke mindre end den anbefalede infusionstid (se pkt.
English: Uncommon: Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction.
Danish: Ikke almindelig: Anafylaktiske reaktioner, Lupus-lignende syndrom, serumsygdom eller serumsygdoms-lignende reaktioner.
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 Remicade.
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 Remicade-koncentrat.
English: • Ulcerative colitis.
Danish: • Colitis ulcerosa.
English: • Maintenance: Additional infusions of 5 mg/kg every 8 weeks or
Danish: • Vedligeholdelse: Yderligere infusionsdoser på 5 mg/kg hver 8. uge eller
English: The efficacy of infliximab was assessed in two multicenter, randomised, double-blind studies: SPIRIT and EXPRESS.
Danish: Effekten af infliximab blev vurderet i to multicenter, randomiserede, dobbeltblinde studier: SPIRIT og EXPRESS.
English: Available data suggest an increased risk for delayed hypersensitivity with increasing Remicade-free interval.
Danish: Eksisterende resultater tyder på en øget risiko for forsinket overfølsomhed ved længerevarende Remicade-fri periode.
English: The concurrent administration of live vaccines with Remicade is not recommended.
Danish: Samtidig administration af levende vacciner og Remicade frarådes.
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 infliximabbehandlede 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: 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: In rheumatoid arthritis, treatment with infliximab reduced infiltration of inflammatory cells into inflamed areas of the joint as well as expression of molecules mediating cellular adhesion, chemoattraction and tissue degradation.
Danish: Ved reumatoid arthritis reducerede behandling med infliximab både infiltration af inflammatoriske celler ind i betændte områder i leddet og ekspression af molekyler, der medierer celleadhæsion, kemotiltrækning og vævsnedbrydning.
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 effekt og sikkerhed af infliximab undersøgt hos 104 patienter med aktiv polyartikulær psoriasis arthritis.
English: Rare: Anaphylactic shock, vasculitis, sarcoid-like reaction.
Danish: Sjælden: Anafylaktisk shock, vasculitis, sarkoid-lignende reaktioner.
English: Psoriasis is an inflammatory disease of the skin.
Danish: Psoriasis er en betændelsessygdom i huden.
English: In an exploratory clinical study evaluating the use of Remicade in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies were reported in Remicade-treated patients compared with control patients.
Danish: I et uddybende klinisk studie, der vurderede anvendelsen af Remicade hos patienter med moderat til svær kronisk obstruktiv lungesygdom (COPD), blev der rapporteret flere maligne sygdomme hos patienter behandlet med Remicade sammenlignet med kontrolpatienter.
English: • Treat active Crohn's disease
Danish: • Behandle aktiv Crohns sygdom
English: • Ankylosing spondylitis (Bechterew's disease)
Danish: • Ankyloserende spondylitis (Bekhterevs sygdom)
English: Patients with moderate or severe heart failure (NYHA class III/IV) (see sections 4.4 and 4.8).
Danish: Patienter med moderat eller svær hjerteinsufficiens (NYHA funktionsklasse III/IV) (se pkt.
English: In the REACH study, 112 patients (6 to 17 years, median age 13.0 years) with moderate to severe, active Crohn's disease (median paediatric CDAI of 40) and an inadequate response to conventional therapies were to receive 5 mg/kg infliximab at weeks 0, 2, and 6.
Danish: I REACH-studiet fik 112 patienter (6 til 17 år, median alder 13,0 år) med moderat til svær aktiv Crohns sygdom (median pædiatrisk CDAI på 40) og utilstrækkelig respons på konventionel behandling 5 mg infliximab/kg i ugerne 0, 2 og 6.
English: Uncommon: Tuberculosis, fungal infections (e.g. candidiasis, onychomycosis).
Danish: Ikke almindelig: Tuberkulose, svampeinfektioner (fx candidiasis, onychomykose).