FrancophonIA/ELRC3.0 huggingface dataset:
English: b all infliximab doses given in combination with methotrexate and folate with some on corticosteroids and/or NSAIDs c p < 0.001, for each infliximab treatment group vs. control d greater values indicate more joint damage.
Danish: b Alle infliximab doser er givet i kombination med methotrexat og folat samt eventuelt kortikosteroider og/eller NSAIDs c p < 0,001, for hver infliximab-behandlingsgruppe versus kontrol d Større værdier indikerer mere uarbejdsdygtighed.
English: Infliximab was studied in a clinical study in 120 patients (age range: 4-17 years old) with active juvenile rheumatoid arthritis despite methotrexate.
Danish: Infliximab blev undersøgt i et klinisk studie med 120 patienter (alder: 4-17 år) med aktiv juvenil reumatoid arthritis til trods for behandling med methotrexat.
English: When reconstitution and dilution are performed under aseptic conditions, Flixabi infusion solution can be used within 24 hours if stored at 2°C to 8°C.
Danish: Når rekonstitution og fortynding er udført under aseptiske forhold, kan Flixabi infusionsvæske anvendes inden for 24 timer, hvis den opbevares ved 2 °C til 8 °C.
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 andet randomiseret, dobbelblindt 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: Visually inspect Flixabi for particulate matter or discolouration prior to administration.
Danish: Undersøg Flixabi visuelt for partikler eller misfarvning før indgivelsen.
English: Flixabi is available in packs containing 1, 2, 3, 4, and 5 vial(s).
Danish: Flixabi findes i pakninger, der indeholder 1, 2, 3, 4 og 5 hætteglas.
English: Infliximab prevented disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNFα 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 TNFα, og fik ved indgift efter sygdomsstart eroderede led til at heles.
English: Tuberculosis, fungal infections (e.g. candidiasis, onychomycosis).
Danish: Tuberkulose, svampeinfektioner (fx candidiasis, onychomykose).
English: Type 1 glass vial with a rubber stopper and aluminium crimp protected by a plastic cap.
Danish: Hætteglas (type 1 glas med en gummiprop og aluminiumshætte beskyttet med et plastiklåg).
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Flixabi and is positive for antibodies against double-stranded DNA, further treatment with Flixabi must not be given (see section 4.8).
Danish: Hvis en patient udvikler symptomer, der viser tegn på et lupus-lignende syndrom efter behandling med Flixabi og er positiv over for antistoffer mod dobbeltstrenget DNA, må behandling med Flixabi ikke fortsættes (se pkt.
English: • Difficult or painful breathing, chest pain
Danish: • Besværet eller smertefuldt åndedræt, smerter i brystet
English: Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction.
Danish: Anafylaktiske reaktioner, Lupus-lignende syndrom, serumsygdom eller serumsygdoms-lignende reaktioner.
English: Your doctor may recommend temporarily stopping Flixabi.
Danish: Din læge kan anbefale en midlertidig pause med Flixabi.
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) i 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: 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: 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: 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: Flixabi must be given concomitantly with methotrexate.
Danish: Flixabi skal anvendes sammen med methotrexat.
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: • Some women being treated for rheumatoid arthritis with infliximab have developed cervical cancer.
Danish: • Nogle kvinder, der er blevet behandlet for reumatoid arthritis med infliximab, har udviklet livmoderhalskræft.
English: Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFα but not to lymphotoxin α (TNFβ).
Danish: Infliximab er et kimerisk human-murin monoklonalt antistof, der binder sig med høj affinitet til både opløselige og transmembrane former af TNFα, men ikke til lymphotoxin α (TNFβ).
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 infektion, herunder svær dissemineret infektion, som kan blive letal.
English: Psoriatic arthritis Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis.
Danish: Psoriasisarthritis er en betændelsessygdom i leddene, almindeligvis ledsaget af psoriasis.
English: • Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease, optic neuritis and Guillain-Barré syndrome
Danish: • Alvorlige lidelser i nervesystemet såsom transversel myelitis, multipel sklerose-lignende sygdom, optisk neuritis og Guillain-Barré syndrom
English: • Some patients who have received TNF-blockers, including Flixabi have developed a rare type of cancer called hepatosplenic T-cell lymphoma.
Danish: • Nogle patienter, som har fået TNF-blokerende behandling, herunder Flixabi, har udviklet en sjælden kræftform kaldet hepatosplenisk T-celle-lymfom.
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 TNFα demonstrated no increase in tumours when challenged with known tumour initiators and/or promoters.
Danish: Studier hos mus, der mangler TNFα, viste ingen stigning i tumorer ved udsættelse for kendte tumorfremkaldere og/ellerfremskyndere.
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 arthritis, som fik 3 mg/kg sammenlignet med 17,5 % af patienterne som fik 6 mg/kg.
English: • Your doctor will also give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Flixabi.
Danish: • Din læge vil også udlevere et patientinformationskort til dig, som indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under din behandling med
English: • You have tuberculosis (TB) or another serious infection such as pneumonia or sepsis.
Danish: • hvis du har tuberkulose (TB) eller en anden alvorlig infektion, såsom lungebetændelse eller blodforgiftning (sepsis),
English: • Treatment with TNF blockers such as Flixabi may result in reactivation of hepatitis B virus in patients who carry this virus, which can be life-threatening in some cases.
Danish: • Behandling med TNF-blokkere, såsom Flixabi, kan medføre, at hepatitis B igen bliver aktiv hos patienter, som bærer denne virus.
English: • Some patients receiving infliximab have developed symptoms of an immune system disorder called lupus.
Danish: • Nogle patienter, der får infliximab, har udviklet symptomer på en sygdom i immunsystemet kaldet lupus.
English: N/A 4.4% N/A 1.5%
Danish: N/A 139 N/A 53,0 N/A 4,4 % N/A 1,5 %
English: Cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis, have been observed in the post-marketing experience of infliximab.
Danish: Tilfælde af gulsot og ikke-infektiøs hepatitis, nogle med tegn på autoimmun hepatitis, er set efter markedsføring af infliximab.
English: Additionally, closure of all fistulae was achieved in 55% of infliximab-treated patients compared with 13% of placebotreated patients (p=0.001).
Danish: Det lykkedes desuden at lukke alle fistler hos 55 % af infliximab-behandlede patienter, sammenlignet med 13 % af patienter behandlet med placebo (p = 0,001).
English: The incidence of serious infections in infliximab-treated patients 65 years and older was greater than in those under 65 years of age.
Danish: Incidensen af alvorlige infektioner var højere hos infliximab-behandlede patienter på 65 år og derover end hos patienter under 65 år.
English: • You have heart failure that is moderate or severe.
Danish: • hvis du har hjertesvigt i moderat eller svær grad.
English: Flixabi is produced in packs of 1, 2, 3, 4, or 5 vial(s).
Danish: Flixabi fremstilles i pakninger med 1, 2, 3, 4 eller 5 hætteglas.
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: 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
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: Marketing Authorisation Holder Samsung Bioepis NL B.V.
Danish: Samsung Bioepis NL B.V.
English: including bovine tuberculosis (disseminated BCG infection), see section 4.4
Danish: * herunder kvægtuberkulose (dissemineret BCG-infektion), se pkt.
English: Infliximab inhibits the functional activity of TNFα in a wide variety of in vitro bioassays.
Danish: Farmakodynamisk virkning Infliximab hæmmer den funktionelle aktivitet af TNFα i en lang række forskellige in vitro bioassays.
English: • Some children and teenage patients who have received TNF-blockers such as Flixabi have developed cancers, including unusual types, which sometimes resulted in death.
Danish: • Nogle børn og unge, som har fået TNF-blokkere såsom Flixabi, har udviklet kræft inklusive usædvanlige typer kræft, som i visse tilfælde har været dødelige.
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: Flixabi 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 Flixabi 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: 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: Agranulocytosis (including infants exposed in utero to infliximab), thrombotic thrombocytopenic purpura, pancytopenia, haemolytic anaemia, idiopathic thrombocytopenic purpura.
Danish: Agranulocytose (inklusive hos spædbørn, der har været eksponeret for infliximab i uterus), trombotisk trombocytopenisk purpura, pancytopeni, hæmolytisk anæmi, idiopatisk trombocytopenisk purpura.
English: N/A 6.7% N/A 1.7%
Danish: N/A 60 N/A 49,4 N/A 6,7 % N/A 1,7 %
English: • Do not breast-feed when you are being treated with Flixabi or for 6 months after your last treatment with Flixabi.
Danish: • Du må ikke amme, mens du er i behandling med Flixabi og i mindst 6 måneder efter din sidste behandling med Flixabi.
English: • You should avoid getting pregnant when you are being treated with Flixabi and for 6 months after you stop being treated with it.
Danish: • Du skal undgå at blive gravid, mens du er i behandling med Flixabi, og i mindst 6 måneder efter du er stoppet med behandlingen.
English: A patient who requires surgery while on Flixabi should be closely monitored for infections, and appropriate actions should be taken.
Danish: En patient, som kræver operation under Flixabi-behandling, bør følges nøje for infektioner, og passende forholdsregler bør tages.
English: What Flixabi contains
Danish: Flixabi indeholder
English: Fewer subjects underwent colectomy in the 5 mg/kg infliximab group (28/242 or 11.6% [N.S.]) and the 10 mg/kg infliximab group (18/242 or 7.4% [p=0.011]) than in the placebo group (36/244; 14.8%).
Danish: Der var færre forsøgspersoner, som fik foretaget kolektomi i 5 mg/kg infliximab- gruppen (28/242 eller 11,6 % [N.S.] og 10 mg/kg infliximab-gruppen (18/242 eller 7.4 % [p = 0,011]) end i placebogruppen (36/244;14,8 %).
English: There are insufficient data on the incidence of delayed hypersensitivity reactions after infliximab-free intervals of more than 1 year but limited data from clinical studies suggest an increased risk for delayed hypersensitivity with increasing infliximab-free interval (see section 4.4).
Danish: Der er utilstrækkelige resultater vedrørende forekomst af forsinkede overfølsomhedsreaktioner efter infliximab-fri perioder på mere end 1 år, men begrænsede resultater fra kliniske studier tyder på en øget risiko for overfølsomhed ved stigende infliximab-fri periode (se pkt.
English: Monobasic sodium phosphate monohydrate Dibasic sodium phosphate heptahydrate
Danish: Monobasisk natriumphosphatmonohydrat Dibasisk natriumphosphatheptahydrat
English: Juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis The safety and efficacy of infliximab 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 Infliximabs sikkerhed og virkning hos børn og unge under 18 år for indikationerne juvenil idiopatisk arthritis, psoriasis arthritis og ankyloserende spondylitis er ikke klarlagt.
English: Caution should be exercised when considering the use of Flixabi in patients with chronic infection or a history of recurrent infections, including concomitant immunosuppressive therapy.
Danish: Der bør udvises forsigtighed, når brug af Flixabi overvejes hos patienter med kronisk infektion eller med en sygdomshistorie med tilbagevendende infektioner, inklusive samtidig behandling med immunsuppressive lægemidler.
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 Flixabi.
Danish: Fortyndingen kan opnås ved at udtrække et volumen af natriumchlorid 9 mg/ml (0,9 %) infusionsvæske, opløsning, fra 250 ml glasflasken eller infusionsposen svarende til voluminet af den rekonstituerede Flixabi-opløsning.
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 Flixabi treatment should be carefully considered before initiation of Flixabi 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 Flixabibehandling overvejes omhyggeligt, før Flixabibehandling initieres.
English: Infusion reactions following re-administration of infliximab 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 infliximab (maximum of four infusions at 0, 2, 6 and 14 weeks) following disease flare.
Danish: Infusionsrelaterede reaktioner efter fornyet indgift af infliximab 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 induktionsregimen med infliximab (højst 4 infusioner efter 0, 2, 6 og 14 uger) efter opblussen af sygdom.
English: Available data do not support further Flixabi treatment, in patients not responding within 6 weeks of the initial infusion.
Danish: Eksisterende resultater støtter ikke fortsat Flixabi-behandling hos patienter, der ikke responderer inden for 6 uger efter den første infusion.
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 indgift med en enkelt infliximab 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 induktionsregimen (se pkt.
English: Calculate the dose and the number of Flixabi vials needed.
Danish: Beregn dosis og det nødvendige antal Flixabi-hætteglas.
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: Hepatitis, hepatocellular damage, cholecystitis.
Danish: Hepatitis, hepatocellulær skade, kolecystitis.
English: Myocardial ischaemia/myocardial infarction.
Danish: Myokardieiskæmi/myokardieinfarkt.
English: In psoriatic arthritis, short term treatment with infliximab reduced the number of T-cells and blood vessels in the synovium and psoriatic skin.
Danish: Ved psoriasis arthritis reducerede korttidsbehandling med infliximab antallet af T-celler og blodkar i synovium og hud med psoriasis.
English: Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and Psoriasis Area and Severity Index [PASI] score ≥ 12).
Danish: Patienter i begge studier havde plaque psoriasis (Body Surface Area [BSA] ≥ 10 % og
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 titers 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 kke påvirkede det T-celle uafhængige humorale immunrespons.
English: Amnesia, agitation, confusion, somnolence, nervousness.
Danish: Amnesi, uro, forvirring, søvnighed, nervøsitet.
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: Clinical remission at week 30
Danish: Klinisk remission i uge 30a
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: Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation.
Danish: Meningitis, opportunistiske infektioner (såsom invasive svampeinfektioner [pneumocystose, histoplasmose, aspergillose, kokcidioidomykose, kryptokokkose, blastomykose], bakterielle infektioner [atypiske mykobakterier, listeria, salmonella] og virale infektioner [cytomegalovirus]), parasitære infektioner, reaktivering af hepatitis B.
English: In clinical studies delayed hypersensitivity reactions have been uncommon and have occurred after infliximab-free intervals of less than 1 year.
Danish: I kliniske studier har forsinkede overfølsomhedsreaktioner været usædvanlige og er forekommet efter infliximab-fri perioder på mindre end 1 år.
English: c a control = All patients had active RA despite treatment with stable methotrexate doses for 6 months prior to enrolment and were to remain on stable doses throughout the study.
Danish: (patienter evalueret) Gennemsnit ± SDc a Kontrol = Alle patienter havde aktiv RA på trods af behandling med stabile methotrexat doser i 6 måneder før inklusion og skulle fortsætte på stabile doser gennem studiet.