FrancophonIA/ELRC3.0 huggingface dataset:
English: EXPRESS evaluated the efficacy of infliximab induction and maintenance therapy in 378 patients with plaque psoriasis.
Danish: EXPRESS vurderede effekten af infliximab induktions- og vedligeholdelsesbehandling hos 378 patienter med plaque psoriasis.
English: Corticosteroid taper was permitted after week 8.
Danish: Kortikosteroidnedtrapning var tilladt efter uge 8.
English: Low blood counts
Danish: Lave blodtal
English: Additional histological studies provided evidence that treatment with infliximab reduces the infiltration of inflammatory cells into affected areas of the intestine and the presence of inflammation markers at these sites.
Danish: Yderligere histologiske studier viste, at behandling med infliximab reducerer infiltreringen af inflammatoriske celler ind i den angrebne del af tarmen og tilstedeværelsen af betændelsesmarkører på disse steder.
English: • Bacterial infections such as blood poisoning, abscess or infection of the skin (cellulitis)
Danish: • Bakterieinfektioner såsom blodforgiftning, byld eller infektion under huden (cellulitis)
English: Uncommon: Pyelonephritis.
Danish: Ikke almindelig: Pyelonefritis.
English: Current administrations:
Danish: Nuværende doseringer:
English: Median follow-up (wks)
Danish: Medianopfølgning (uger)
English: In ACT 1 and ACT 2, infliximab improved quality of life, confirmed by statistically significant improvement in both a disease specific measure, IBDQ, and by improvement in the generic 36-item short form survey SF-36.
Danish: Infliximab forbedrede livskvaliteten i ACT 1 og ACT 2, hvilket bekræftedes ved statistisk signifikant forbedring i både et sygdomsspecifikt mål, IBDQ, og ved forbedring i den almindelige 36-punkt korte udgave af spørgeskema SF-36.
English: • Liver problem that causes yellowing of the skin or eyes (jaundice)
Danish: • Leverproblemer, der giver gulfarvning af hud eller øjne (gulsot)
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor).
Danish: Alle patienter skal rådes til straks at søge læge, hvis de udvikler tegn og symptomer, som tyder på bloddyskrasi (fx vedvarende feber, blå mærker, blødning eller bleghed).
English: Corticosteroids do not appear to affect the pharmacokinetics of infliximab to a clinically relevant extent.
Danish: Kortikosteroider har tilsyneladende ingen klinisk relevant effekt på infliximabs farmakokinetik.
English: A reduction in the rate of the progression of structural joint damage (erosions and joint space narrowing) was observed in all infliximab groups at 54 weeks (Table 3).
Danish: En reduktion i hastigheden af progressionen af strukturel ledskade (erosioner og forsnævring af ledspalte) blev set i alle infliximab-grupper ved 54 uger (tabel 3).
English: • Tuberculosis
Danish: • Tuberkulose
English: Psoriatic arthritis, ankylosing spondylitis (Bechterew's disease), psoriasis, ulcerative colitis and Crohn's disease
Danish: Psoriasisarthritis, ankyloserende spondylitis (Bekhterevs sygdom), psoriasis, colitis ulcerosa og Crohns sygdom
English: • If your doctor feels that you are at risk for TB, you may be treated with medicines for TB
Danish: • Hvis din læge tror, at du har risiko for at få TB, kan du blive behandlet med lægemidler mod TB, inden du får Remicade.
English: At 54 weeks, 44.9% of patients in the combined infliximab treatment group were in clinical response compared to 19.8% in the placebo treatment group (p < 0.001).
Danish: Ved 54 uger var 44,9 % af patienterne i den kombinerede infliximab-behandlingsgruppe i klinisk respons sammenlignet med 19,8 % i placebobehandlingsgruppen (p < 0,001).
English: Elevated concentrations of TNF have been found in the joints of rheumatoid arthritis patients and correlate with elevated disease activity.
Danish: Forhøjede koncentrationer af TNF er blevet fundet i leddene hos reumatoid arthritis patienter og korrelerer med øget sygdomsaktivitet.
English: The co-primary endpoints were the proportion of patients in clinical remission (CDAI < 150) at week 30 and time to loss of response through week 54.
Danish: De co-primære endepunkter var forholdet af patienter i klinisk remission (CDAI < 150) ved uge 30 og tiden til tab af respons efter uge 54.
English: Do not use if visibly opaque particles, discolouration or foreign particles are observed.
Danish: Anvendes ikke, hvis der observeres synligt uigennemsigtige partikler, misfarvning eller fremmedlegemer.
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 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: Infections occurred in 68% (41/60) of children receiving 3 mg/kg over 52 weeks, 65% (37/57) of children receiving infliximab 6 mg/kg over 38 weeks and 47% (28/60) of children receiving placebo over 14 weeks (see section 4.4).
Danish: Der opstod infektioner hos 68 % (41/60) af de børn, som fik 3 mg/kg over 52 uger, 65 % (37/57) af de børn, som fik infliximab 6 mg/kg over 38 uger og 47 % (28/60) af de børn som fik placebo over 14 uger (se pkt.
English: In a clinical study of patients with Crohn's disease (SONIC), infusion-related reactions occurred in 16.6% (27/163) of patients receiving infliximab monotherapy, 5% (9/179) of patients receiving infliximab in combination with AZA, and 5.6% (9/161) of patients receiving AZA monotherapy.
Danish: I et klinisk studie med patienter med Crohns sygdom (SONIC) forekom infusionsrelaterede reaktioner hos 16,6 % (27/163) af de patienter, som fik infliximab monoterapi, hos 5 % (9/179) af de patienter, som fik infliximab kombineret med AZA, og hos 5,6 % (9/161) af de patienter, som fik AZA monoterapi.
English: Placebo (week 24)
Danish: Placebo (uge 24)
English: At week 24, all placebo-treated patients crossed over to infliximab induction.
Danish: I uge 24 blev alle placebobehandlede patienter flyttet over til infliximab induktion.
English: • Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson Syndrome and acute generalised exanthematous pustulosis
Danish: • Alvorlige hudproblemer såsom toksisk epidermal nekrolyse, Stevens-Johnsons syndrom og akut generaliseret eksantematøs pustulose
English: EU/1/99/116/001 1 vial 100 mg EU/1/99/116/002 2 vials 100 mg EU/1/99/116/003 3 vials 100 mg EU/1/99/116/004 4 vials 100 mg EU/1/99/116/005 5 vials 100 mg
Danish: EU/1/99/116/001 1 hætteglas 100 mg EU/1/99/116/002 2 hætteglas 100 mg EU/1/99/116/003 3 hætteglas 100 mg EU/1/99/116/004 4 hætteglas 100 mg EU/1/99/116/005 5 hætteglas 100 mg
English: A total of 573 patients with moderately to severely active Crohn's disease (CDAI ≥ 220 ≤ 400) received a single infusion of 5 mg/kg at week 0.
Danish: I alt 573 patienter med moderat til svær aktiv Crohns sygdom (CDAI ≥ 220 ≤ 400) fik en enkelt infusionsdosis på 5 mg/kg ved uge 0.
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: Use of concomitant immunosuppressant agents appeared to reduce the frequency of infusion-related reactions.
Danish: Samtidig brug af immunsupprimerende stoffer syntes at reducere hyppigheden af infusionsrelaterede reaktioner.
English: Patients may be pre-treated with e.g., an antihistamine, hydrocortisone and/or paracetamol and infusion rate may be slowed in order to decrease the risk of infusion-related reactions especially if infusion-related reactions have occurred previously (see section 4.4).
Danish: Patienter kan præmedicineres med fx et antihistamin, hydrocortison og/eller paracetamol og infusionshastigheden reduceres for at nedsætte risikoen for infusionsrelaterede reaktioner, især hvis infusionsrelaterede reaktioner er set tidligere (se pkt.
English: In rheumatoid arthritis patients who received the recommended repeated treatment dose regimens with methotrexate, 8% of patients developed antibodies to infliximab.
Danish: Hos patienter med reumatoid arthritis, der fik det anbefalede regimen med gentagne behandlingsdoser med methotrexat, udviklede 8 % af patienterne antistoffer mod infliximab.
English: • Some patients who have received TNF-blockers, including Remicade have developed a rare type of cancer called hepatosplenic T-cell lymphoma.
Danish: • Nogle patienter, som har fået TNF-blokerende behandling, herunder Remicade, har udviklet en sjælden kræftform kaldet hepatosplenisk T-celle-lymfom.
English: Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of > 5% include pneumocystosis, candidiasis, listeriosis and aspergillosis.
Danish: Nogle af disse infektioner har været letale; de opportunistiske infektioner, der oftest er set med en mortalitetsrate > 5 %, indbefatter pneumocystose, candidiasis, listeriose og aspergillose.
English: Tell your doctor straight away if you notice any of the following:
Danish: Fortæl straks din læge, hvis du bemærker noget af følgende:
English: • Tell your doctor if you are going to have any operations or dental procedures.
Danish: • Fortæl din læge, hvis du skal have foretaget en operation eller et tandindgreb.
English: In psoriatic arthritis, short term treatment with Remicade reduced the number of T-cells and blood vessels in the synovium and psoriatic skin.
Danish: Ved psoriasis arthritis reducerede korttidsbehandling med Remicade antallet af T-celler og blodkar i synovium og hud med psoriasis.
English: Infliximab prevented disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNF and when administered after disease onset, it allowed eroded joints to heal.
Danish: Infliximab forebyggede sygdom hos transgene mus, der udvikler polyarthritis som resultat af konstitutiv ekspression af human TNF, og fik ved indgift efter sygdomsstart eroderede led til at heles.
English: Secondary endpoints included the proportion of patients in clinical remission at week 4 (CDAI < 150) and clinical response over time.
Danish: Sekundære endepunkter omfattede andelen af patienter i klinisk remission i uge 4 (CDAI < 150) og den kliniske respons på længere sigt.
English: EXPRESS Placebo → Infliximab 5 mg/kg (at week 24)
Danish: EXPRESS Placebo → Infliximab 5 mg/kg (i uge 24)
English: For preparation and administration instructions, see section 6.6.
Danish: For instruktioner vedrørende tilberedning og administration, se pkt.
English: Rare: Lymphoma, non-Hodgkin's lymphoma, Hodgkin's disease, leukaemia, melanoma, cervical cancer.
Danish: Sjældne: Lymfom, non-Hodgkins lymfom, Hodgkins sygdom, leukæmi, melanom, livmoderhalskræft.
English: Patients with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections (see section 4.4).
Danish: Patienter med tuberkulose eller andre alvorlige infektioner såsom sepsis, abscesser og opportunistiske infektioner (se pkt.
English: Total peripheral white blood cell counts were minimally affected in infliximab-treated patients, although changes in lymphocytes, monocytes and neutrophils reflected shifts towards normal ranges.
Danish: Det totale perifere antal hvide blodlegemer blev kun påvirket i ubetydeligt omfang hos patienter behandlet med infliximab, omend ændringer i lymfocytter, monocytter og neutrofile viste skift inden for normalområderne.
English: Not known: Liver failure.
Danish: Ikke kendt: Leversvigt.
English: Administer the infusion solution over a period of not less than the infusion time recommended.
Danish: Indgiv infusionsvæsken over en periode på ikke mindre end den anbefalede infusionstid.
English: Group 1 received 5 mg/kg infliximab.
Danish: Gruppe 1 fik 5 mg/kg infliximab.
English: • Narrowed airway in the lungs, causing difficulty breathing
Danish: • Forsnævrede luftveje i lungerne, der giver åndedrætsbesvær
English: > 40 weeks
Danish: > 40 uger
English: More signs of allergic side effects that may happen up to 12 days after your injection include pain in the muscles, fever, joint or jaw pain, sore throat or headache.
Danish: Yderligere tegn på allergiske bivirkninger, som kan opstå op til 12 dage efter din injektion, inkluderer muskelsmerter, feber, led- eller kæbesmerter, ondt i halsen eller hovedpine.
English: Studies in mice deficient in TNF demonstrated no increase in tumours when challenged with known tumour initiators and/or promoters.
Danish: Studier hos mus, der mangler TNF, viste ingen stigning i tumorer ved udsættelse for kendte tumorfremkaldere og/eller -fremskyndere.
English: • Low blood counts, including a severely decreased number of white blood cells
Danish: • Lave blodtal, herunder svært nedsat antal hvide blodlegemer
English: Remicade was studied in a clinical study in 120 patients (age range: 4-17 years old) with active juvenile rheumatoid arthritis despite methotrexate.
Danish: Remicade blev undersøgt i et klinisk studie med 120 patienter (alder: 4-17 år) med aktiv juvenil reumatoid arthrithis til trods for behandling med methotrexat.
English: In particular, tell your doctor if you are using any of the following medicines:
Danish: Det er specielt vigtigt, at du fortæller din læge, hvis du får nogen af følgende lægemidler:
English: Not known: Myocardial ischaemia/myocardial infarction.
Danish: Ikke kendt: Myokardieiskæmi/myokardieinfarkt.
English: Because of the nature of the adverse reactions seen with combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNF-blocking agents.
Danish: Grundet egenskaberne af bivirkningerne set ved kombinationsbehandlingen med etanercept og anakinra, kan lignende toksiciteter muligvis forekomme ved kombination af anakinra med andre TNFα-blokerende midler.
English: Juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis The safety and efficacy of Remicade in children and adolescents younger than 18 years for the indications of juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Danish: Juvenil idiopatisk arthritis, psoriasis arthritis og ankyloserende spondylitis Remicades sikkerhed og virkning hos børn og unge under 18 år for indikationerne juvenil idiopatisk arthritis, psoriasis arthritis og ankyloserende spondylitis er ikke klarlagt.
English: No physical biochemical compatibility studies have been conducted to evaluate the co-administration of Remicade with other agents.
Danish: Der er ikke gennemført biokemiske forligelighedsstudier for at vurdere samtidig indgivelse af Remicade med andre midler.
English: Store at 2 °C - 8 °C.
Danish: Opbevares ved 2 °C - 8 °C.
English: However, if the solution is prepared in germ-free conditions, it can be stored in a refrigerator at 2 °C to 8 °C up to 28 days and for an additional 24 hours at 25 °C after removal from the refrigerator.
Danish: Hvis opløsningen er klargjort under aseptiske betingelser, kan den dog opbevares i køleskab ved 2 °C - 8 °C i op til 28 dage og i yderligere 24 timer ved 25 °C efter udtagning fra køleskab.
English: Beginning at week 14, patients who had responded to treatment, but subsequently lost their clinical benefit, were allowed to cross over to a dose of infliximab 5 mg/kg higher than the dose to which they were originally randomised.
Danish: I begyndelsen af uge 14 fik patienter, der havde responderet på behandling, men efterfølgende mistet deres kliniske fordel, lov til at krydse over til en infliximab-dosis på 5 mg/kg højere end den dosis hvortil de oprindeligt var randomiseret.
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: Concomitant administration of immunomodulators has been associated with lower incidence of antibodies to infliximab and a reduction in the frequency of infusion reactions.
Danish: Samtidig administration af immunmodulatorer er blevet forbundet med en lavere hyppighed af antistoffer over for infliximab og en reduktion i frekvensen af infusionsreaktioner.
English: If serious reactions occur, symptomatic treatment must be given and further Remicade infusions must not be administered (see section 4.8).
Danish: Hvis alvorlige reaktioner opstår, skal symptomatisk behandling gives, og der må ikke gives yderligere Remicadeinfusioner (se pkt.
English: Patients should be advised to seek immediate medical advice if they experience any delayed adverse reaction (see section 4.8).
Danish: Patienter bør rådes til at søge øjeblikkelig lægehjælp, hvis de oplever en forsinket bivirkning (se pkt.
English: Of these patients, most were teenage boys or young men and most had either Crohn's disease or ulcerative colitis.
Danish: Af disse patienter var de fleste teenagedrenge eller unge mænd, hvoraf de fleste havde enten Crohns sygdom eller colitis ulcerosa.
English: Rare: Autoimmune hepatitis, jaundice.
Danish: Sjælden: Autoimmun hepatitis, gulsot.
English: In rheumatoid arthritis, psoriatic arthritis and Crohn's disease patients, there are indications that concomitant use of methotrexate and other immunomodulators reduces the formation of antibodies against infliximab and increases the plasma concentrations of infliximab.
Danish: Hos patienter med reumatoid arthritis, psoriasis arthritis og Crohns sygdom tyder det på, at samtidig anvendelse af methotrexat og andre immunmodulatorer reducerer dannelsen af antistoffer mod infliximab og forøger plasmakoncentrationerne af infliximab.
English: • Immune disorders that could affect the lungs, skin and lymph nodes (such as sarcoidosis).
Danish: • Immunsystemdefekt, som kan påvirke lunger, hud og lymfekirtler (såsom sarkoidose)
English: • You should avoid getting pregnant when you are being treated with Remicade and for 6 months after you stop being treated with it.
Danish: • Du skal undgå at blive gravid, mens du er i behandling med Remicade, og i mindst 6 måneder efter du er stoppet med behandlingen.
English: The reduction in incidence of colectomy was also examined in another randomised, double-blind study (C0168Y06) in hospitalised patients (n = 45) with moderately to severely active ulcerative colitis who failed to respond to intravenous corticosteroids and who were therefore at higher risk for colectomy.
Danish: Reduktionen i hyppigheden af kolektomi blev også undersøgt i et anden randomiseret, dobbelblind studie (C0168Y06) af hospitaliserede patienter (n = 45) med moderat til svær aktiv colitis ulcerosa, som ikke responderede på intravenøse kortikosteroider, og som derfor havde større risiko for kolektomi.
English: Please make sure you also have a list of all other medicines that you are using with you at any visit to a healthcare professional.
Danish: Du skal sikre dig, at du ved hvert lægebesøg også medbringer en liste over alle andre lægemidler, som du bruger.
English: • More children taking Remicade developed infections as compared to adults.
Danish: • Flere børn end voksne, der får Remicade, fik infektioner.
English: • Do not breast-feed when you are being treated with Remicade or for 6 months after your last treatment with Remicade.
Danish: • Du må ikke amme, mens du er i behandling med Remicade og i mindst 6 måneder efter din sidste behandling med Remicade.
English: Peripheral blood mononuclear cells (PBMC) from infliximab-treated patients showed undiminished proliferative responsiveness to stimuli compared with untreated patients, and no substantial changes in cytokine production by stimulated PBMC were observed following treatment with infliximab.
Danish: Perifere mononukleære blodceller (PBMC) fra patienter behandlet med infliximab udviste usvækket proliferativ reaktion på stimuli sammenlignet med patienter, der ikke var behandlet, og der konstateredes ingen væsentlige ændringer i cytokinproduktion hos stimuleret PBMC efter behandling med infliximab.
English: Corticosteroid tapering was permitted after week 6.
Danish: Kortikosteroid nedtrapning var tilladt efter uge 6.
English: In the 6 mg/kg group, 2 out of 57 patients had a serious infusion reaction, one of whom had a possible anaphylactic reaction (see section 4.4).
Danish: I 6 mg/kg gruppen fik 2 ud af 57 patienter en alvorlig infusionsreaktion, hvoraf en fik en mulig anafylaktisk reaktion (se pkt.
English: • Temporary loss of sight during or within 2 hours of infusion
Danish: • Midlertidigt synstab under eller inden for 2 timer efter infusionen
English: Additionally, closure of all fistulae was achieved in 55% of infliximab-treated patients compared with 13% of placebo-treated patients (p = 0.001).
Danish: Det lykkedes desuden at lukke alle fistler hos 55 % af infliximab-behandlede patientersammenlignet med 13 % af patienter behandlet med placebo (p = 0,001).
English: Concurrent administration with other biological therapeutics There is insufficient information regarding the concomitant use of infliximab with other biological therapeutics used to treat the same conditions as infliximab.
Danish: Samtidig administration af anden biologisk behandling Der foreligger ikke tilstrækkelig information om samtidig brug af infliximab og andre biologiske lægemidler til behandling af de samme lidelser som infliximab.
English: Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNF but not to lymphotoxin  (TNFß).
Danish: Infliximab er et kimerisk human-murin monoklonalt antistof, der binder sig med høj affinitet til både opløselige og transmembrane former af TNF, men ikke til lymphotoxin  (TNF).
English: • Difficult or painful breathing, chest pain
Danish: • Besværet eller smertefuldt vejrtrækning, smerter i brystet
English: Patients were randomised to receive AZA monotherapy, infliximab monotherapy, or infliximab plus AZA combination therapy.
Danish: Patienterne blev randomiseret til at få AZA monoterapi, infliximab-monoterapi eller infliximab plus AZA kombinationsterapi.
English: If you forget or miss an appointment to receive Remicade, make another appointment as soon as possible.
Danish: Hvis du har glemt eller kommer for sent til din Remicade-infusion Hvis du glemmer eller kommer for sent til en aftale, hvor Remicade gives, skal du lave en ny aftale så hurtigt som muligt.
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 Remicade treatment should be carefully considered before initiation of Remicade 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 Remicadebehandling overvejes omhyggeligt, før Remicadebehandling initieres.
English: Common: Bacterial infections (e.g. sepsis, cellulitis, abscess).
Danish: Almindelig: Bakterielle infektioner (fx sepsis, cellulitis, absces).
English: Type 1 glass vial with rubber stopper and aluminium crimp protected by a plastic cap.
Danish: Hætteglas (type 1 glas med gummiprop og aluminiumshætte beskyttet med et plastiklåg).