FrancophonIA/ELRC3.0 huggingface dataset:
English: A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p < 0.001, pooled ACT 1 & ACT 2 data) and week 54 (21.0% vs. 8.9%, p=0.022, ACT 1 data).
Danish: En større andel patienter i den kombinerede infliximab-behandlingsgruppe var i stand til at afbryde kortikosteroider og stadig blive i klinisk remission sammenlignet med placebobehandlingsgruppen i både uge 30 (22,3 % mod 7,2 %, p < 0,001, samlede ACT 1- & ACT 2-data) og uge 54 (21,0 % mod 8,9 %, p = 0,022, ACT 1-data).
English: Before treatment with Flixabi
Danish: Før behandling med Flixabi
English: Hypotension, hypertension, ecchymosis, hot flush, flushing.
Danish: Hypotension, hypertension, ekkymose, hedeture, blussen.
English: • The other ingredients are sucrose, polysorbate 80, monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate.
Danish: • Øvrige indholdsstoffer: saccharose, polysorbat 80, monobasisk natriumphosphatmonohydrat og dibasisk natriumphosphatheptahydrat.
English: Week 30
Danish: Uge 30
English: The safety and efficacy of infliximab have not been studied in children with Crohn's disease below the age of 6 years.
Danish: Infliximabs sikkerhed og virkning hos børn under 6 år med Crohns sygdom er ikke undersøgt.
English: • More children taking Flixabi developed infections as compared to adults.
Danish: • Flere børn end voksne, der får Flixabi, fik infektioner.
English: In both studies, patients were randomised to receive either placebo, 5 mg/kg infliximab, or 10 mg/kg infliximab at weeks 0, 2, 6, 14 and 22, and in ACT 1 at weeks 30, 38 and 46.
Danish: I begge studier var patienterne randomiseret til at få enten placebo, 5 mg/kg infliximab eller 10 mg/kg infliximab i uge 0, 2, 6, 14 og 22, og i ACT 1 i uge 30, 38 og 46.
English: • Signs of a liver problem (including hepatitis B infection when you have had hepatitis B in the past) such as yellowing of the skin or eyes, dark-brown coloured urine, pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever
Danish: Tegn på leverproblemer (inklusive hepatitis B-infektion, hvis du tidligere har haft hepatitis B) såsom gulfarvning af hud eller øjne, mørkebrun urin, smerter eller hævelser i øvre højre side af maven, ledsmerter, hududslæt eller feber
English: Sixty eight percent (21/31) of infliximab-treated patients receiving a 5 mg/kg dose regimen achieved a clinical response vs. 26% (8/31) placebo-treated patients (p=0.002).
Danish: Otteogtres procent (21/31) af patienter behandlet med infliximab, der fik et 5 mg/kg doseringsregimen, opnåede en klinisk effekt mod 26 % (8/31) af placebobehandlede patienter (p = 0,002).
English: Discontinuation of Flixabi therapy should be considered in patients with confirmed significant haematologic abnormalities.
Danish: Seponering af Flixabi-behandling bør overvejes hos patienter, hvor signifikante blodanormaliteter er bekræftet.
English: Crohn's disease Crohn's disease is an inflammatory disease of the bowel.
Danish: Crohns sygdom er en betændelsessygdom i tarmen.
English: • Other skin problems such as erythema multiforme, lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes), blisters and peeling skin, or boils
Danish: • Andre hudproblemer såsom erythema multiforme, lichenoide reaktioner (kløende, rødligt-lilla hududslæt og/eller trådlignende gråhvide linjer på slimhinderne), blærer og afskalning af huden eller bylder (furunkulose)
English: Biogen Finland Oy Puh/Tel: + 358 (0)9 427 041 08
Danish: Suomi/Finland Biogen Finland Oy Puh/Tel: + 358 (0)9 427 041 08
English: There have been post-marketing reports of worsening heart failure, with and without identifiable precipitating factors, in patients taking infliximab.
Danish: Efter markedsføring er der rapporteret tilfælde af forværret hjerteinsufficiens hos infliximabpatienter, med eller uden identificerbare prædisponerende faktorer.
English: Flixabi is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1).
Danish: Flixabi er indiceret til behandling af moderat til svær plaque psoriasis hos voksne patienter, som ikke responderede på, eller som har en kontraindikation for eller som ikke tåler anden systemisk behandling inklusive ciclosporin, methotrexat eller psoralen ultraviolet A (PUVA) (se pkt.
English: Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia.
Danish: Hjerteinsufficiens (debuterende eller forværret), arytmi, besvimelse, bradykardi.
English: • A rare blood cancer affecting mostly teenage boys or young men (hepatosplenic T-cell lymphoma)
Danish: • En sjælden blodkræft, som hovedsageligt rammer teenagedrenge eller unge mænd
English: • You should receive recommended vaccinations before starting Flixabi treatment.
Danish: • Du skal have de anbefalede vaccinationer, før du starter behandling med Flixabi.
English: A risk for the development for hepatosplenic T-cell lymphoma in patients treated with Flixabi cannot be excluded (see section 4.8).
Danish: En risiko for udvikling af hepatosplenisk T-celle-lymfom hos patienter, der bliver behandlet med Flixabi, kan ikke udelukkes (se pkt.
English: If you are not sure, talk to your doctor before you are given Flixabi.
Danish: Hvis du er i tvivl, så kontakt lægen, før du får Flixabi.
English: • Swelling of the liver (hepatitis) or gall bladder, liver damage
Danish: • Hævelse af lever (hepatitis) eller galdeblæren, leverskade
English: In the first study (P01522), which had a 3 month double-blind phase, 70 patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6 (35 patients in each group).
Danish: I det første studie (P01522), som havde en dobbeltblind fase på 3 måneder, modtog 70 patienter enten 5 mg/kg infliximab eller placebo i uge 0, 2, 6 (35 patienter i hver gruppe).
English: • Abnormal values of a blood protein called ‘complement factor' which is part of the immune system.
Danish: • Små røde eller lilla pletter, der skyldes blødning under huden • Unormale værdier for et protein i blodet kaldet ‘komplementfaktor', som er en del af immunsystemet.
English: Flixabi should be administered intravenously.
Danish: Flixabi administreres intravenøst.
English: In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/pharyngeal oedema and severe bronchospasm, and seizure have been associated with infliximab administration (see section 4.4).
Danish: Efter markedsføring er hændelser af anafylaktisk lignende reaktioner, inklusive strube/spiserørs ødemer og alvorlige bronkospasmer, og kramper blevet forbundet med administrering af infliximab (se pkt.
English: Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients receiving infliximab.
Danish: Tuberkulose, bakterieinfektioner, inklusive sepsis og pneumoni, invasive svampeinfektioner, virale infektioner og andre opportunistiske infektioner har været observeret hos patienter, der fik infliximab.
English: In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, there was no indication of maternal toxicity, embryotoxicity or teratogenicity (see section 5.3).
Danish: I et toksicitetsstudie vedrørende udvikling udført på mus med et analogt antistof, som selektivt hæmmer den funktionelle aktivitet af muse- TNFα, var der ingen tegn på maternal toksicitet, embryotoksicitet eller teratogenicitet (se pkt.
English: Neutropenia, leucopenia, anaemia, lymphadenopathy.
Danish: Neutropeni, leukopeni, anæmi, lymfadenopati.
English: Infliximab Maintenance 5 mg/kg (n=113) (p value)
Danish: Infliximabvedligeholdelse 5 mg/kg (n = 113) (p-værdi)
English: In post-marketing surveillance, cases of jaundice and hepatitis, some with features of autoimmune hepatitis, have been reported in patients receiving infliximab (see section 4.4).
Danish: Under overvågning efter markedsføring er der rapporteret tilfælde af gulsot og hepatitis, nogle med tegn på autoimmun hepatitis, hos patienter, der fik infliximab (se pkt.
English: Do not dilute the reconstituted Flixabi solution with any other diluent.
Danish: Fortynd ikke det rekonstituerede Flixabi-koncentrat med andre infusionsvæsker.
English: • Skin problems such as blistering, warts, abnormal skin colouration or pigmentation, or swollen lips, or thickening of the skin, or red, scaly and flaky skin
Danish: • Hudproblemer såsom blæredannelse, vorter, unormal hudfarve eller pigmentering, eller hævede læber, eller fortykkelse af huden eller rød, skællende hud og afskalning af huden
English: Patients assessed by the investigator to be in clinical response at week 10 were randomised and received 5 mg/kg infliximab at either q8 weeks or q12 weeks as a maintenance treatment regimen.
Danish: De patienter, som af investigator blev vurderet til at have et klinisk respons i uge 10, blev randomiseret og fik 5 mg/kg infliximab enten hver 8. eller hver 12. uge som et vedligeholdelsesbehandlingsregimen.
English: Clinical Remission
Danish: Klinisk responsa Klinisk remission
English: * P-values represent each infliximab treatment group vs. AZA monotherapy
Danish: (p < 0,001)* * P-værdier repræsenterer hver infliximab-behandlingsgruppe vs. AZA monoterapi.
English: Infliximab Maintenance 10 mg/kg (n=112) (p value)
Danish: Infliximabvedligeholdelse 10 mg/kg (n = 112) (p-værdi)
English: Hepatic function abnormal, transaminases increased.
Danish: Unormal leverfunktion, forhøjede leveraminotransferaser.
English: Some cases of active tuberculosis have been reported in patients treated with Flixabi during and after treatment for latent tuberculosis.
Danish: Der er rapporteret om enkelte tilfælde af aktiv tuberkulose under og efter behandling for latent tuberkulose hos patienter i behandling med Flixabi.
English: • Inflamed lining of the lung, causing sharp chest pains that feel worse with breathing (pleurisy)
Danish: • Lungehindebetændelse, der giver skarpe smerter, som forværres ved vejrtrækning (pleuritis)
English: The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of juvenile rheumatoid arthritis have not been established.
Danish: Infliximabs sikkerhed og virkning hos børn og unge under 18 år for indikationen juvenil reumatoid arthritis er ikke klarlagt.
English: Post-marketing spontaneous serious adverse reactions with infliximab in the paediatric population have included malignancies including hepatosplenic T-cell lymphomas, transient hepatic enzyme abnormalities, lupus-like syndromes, and positive auto-antibodies (see sections 4.4 and 4.8).
Danish: Spontane alvorlige bivirkninger hos børn efter markedsføring af infliximab inkluderer maligniteter inklusive hepatosplenisk T-celle-lymfom, forbigående leverenzymabnormaliteter, lupus lignende syndromer og positive autoantistoffer (se pkt.
English: • Signs of an immune system disorder such as joint pain or a rash on cheeks or arms that is sensitive to the sun (lupus) or cough, shortness of breath, fever or skin rash (sarcoidosis)
Danish: • Tegn på en sygdom i immunsystemet såsom ledsmerter, udslæt på kinderne eller arme, som er følsomme over for solen (lupus) eller hoste, åndenød, feber eller hududslæt (sarkoidose)
English: The most commonly reported infections were upper respiratory tract infection and pharyngitis, and the most commonly reported serious infection was abscess.
Danish: De mest almindeligt rapporterede infektioner var øvre luftvejsinfektioner og faryngitis.
English: The proportions of patients with mucosal healing at week 26 were significantly greater in the infliximab plus AZA combination (43.9%, p < 0.001) and infliximab monotherapy groups (30.1%, p=0.023) compared to the AZA monotherapy group (16.5%).
Danish: Andelen af patienter med slimhindeheling i uge 26 var signifikant større i grupperne, der fik infliximab plus AZA (43,9 %; p < 0,001) eller infliximab-monoterapi (30,1 %; p = 0,023) sammenlignet med AZAmonoterapigruppen (16,5 %).
English: The number of ulcerative colitis-related hospitalisations was significantly lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of hospitalisations per 100 subject-years: 21 and 19 vs. 40 in the placebo group; p=0.019 and p=0.007, respectively).
Danish: Antallet af hospitalsindlæggelser relateret til colitis ulcerosa var signifikant lavere i 5 og 10 mg/kg infliximab-behandlingsgrupperne end i placebogruppen (gennemsnitligt antal hospitalsindlæggelser per 100 forsøgsperson-år: 21 og 19 versus 40 i placebogruppen; hhv. p = 0,019 og p = 0,007).
English: The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of psoriasis have not been established.
Danish: Infliximabs sikkerhed og virkning hos børn og unge under 18 år for indikationen psoriasis er ikke klarlagt.
English: Cases of transient visual loss occurring during or within 2 hours of infliximab infusion have been reported.
Danish: Der er set tilfælde af kortvarigt synstab under infusion eller inden for 2 timer efter infusion af infliximab.
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Flixabi.
Danish: Hvis du er i tvivl, om noget af ovenstående passer på dig, skal du kontakte lægen eller apotekspersonalet, før du får Flixabi.
English: Concurrent administration of TNF-alpha inhibitor and anakinra 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: Infections • Tell your doctor before you are given Flixabi if you have an infection even if it is a very minor one.
Danish: • Fortæl din læge, før du får Flixabi, hvis du har en infektion, også selvom det er en meget let infektion.
English: The number of ulcerative colitis-related surgical procedures was also lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of surgical procedures per 100 subject-years: 22 and 19 vs. 34; p=0.145 and p=0.022, respectively).
Danish: Antallet af kirurgiske indgreb relateret til colitis ulcerosa var også lavere i 5 og 10 mg/kg infliximab-behandlingsgrupperne end i placebogruppen (gennemsnitligt antal kirurgiske indgreb per 100 forsøgsperson-år: 22 og 19 versus 34; hhv. p = 0,145 og p = 0,022).
English: • Signs of a heart problem such as chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea (feeling sick), vomiting, fluttering or pounding in your chest, a fast or a slow heartbeat, and swelling of your feet.
Danish: • Tegn på hjerteproblemer såsom ubehag i brystkassen eller brystsmerter, armsmerter, mavesmerter, åndenød, angst, ørhed, svimmelhed, besvimelse, svedtendens, kvalme, (utilpashed) opkastning, flakkende hjerte eller trykken i brystet, et hurtigt eller langsomt hjerteslag og hævelse af dine fødder.
English: The vast majority of infliximab cases have occurred in patients with Crohn's disease or ulcerative colitis and most were reported in adolescent or young adult males.
Danish: Hos patienter, som fik infliximab, er langt de fleste tilfælde forekommet hos patienter med Crohns sygdom eller colitis ulcerosa og de fleste blev rapporteret hos unge eller unge voksne mænd.
English: Pregnancy and breast-feeding, and fertility
Danish: Graviditet, amning og frugtbarhed
English: • Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection of pus in the gut or around the anus (abscess), dental problems or burning sensation when urinating
Danish: • Tegn på infektion (inklusive tuberkulose (TB)) såsom feber, træthedsfølelse, hoste, der kan være vedvarende, åndenød, influenzalignende symptomer, vægttab, natlig svedtendens, diarré, sår, ansamling af pus i tarmen eller omkring anus (absces), tandproblemer eller brændende smerte, når du lader vandet
English: Excipients: sucrose, polysorbate 80, monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate.
Danish: Hjælpestoffer: Saccharose, polysorbat 80, monobasisk natriumphosphatmonohydrat og dibasisk natriumphosphatheptahydrat.
English: New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis,
Danish: Debuterende eller forværring af allerede eksisterende psoriasis, inklusive pustuløs psoriasis (primært palmoplantaris), urticaria, udslæt, pruritus, øget svedtendens, tør hud, svampedermatitis, eksem, alopeci.
English: Clinical remission and mucosal healing occurred in a greater proportion of patients in the combined infliximab treatment group compared to the placebo treatment group at week 54 (34.6% vs. 16.5%, p < 0.001 and 46.1% vs. 18.2%, p < 0.001, respectively).
Danish: Klinisk remission og slimhindeheling forekom i en større andel af patienterne i den kombinerede infliximabbehandlingsgruppe sammenlignet med placebobehandlingsgruppen i uge 54 (henholdsvis 34,6 % mod 16,5 %, p < 0,001 og 46,1 % mod 18,2 %, p < 0,001).
English: Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab (see section 4.8).
Danish: Der er rapporteret om melanom og Merkelcellekarcinom hos patienter, der har fået TNF-blokerende behandling, herunder infliximab (se pkt.
English: Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Flixabi.
Danish: Fortæl straks din læge, hvis du får nye eller forværrede tegn på hjertesvigt under behandlingen med Flixabi.
English: Peripheral ischaemia, thrombophlebitis, haematoma.
Danish: Perifer iskæmi, tromboflebitis, hæmatom.
English: Do not use if opaque particles, discolouration, or other foreign particles are present.
Danish: Opløsningen må ikke anvendes, hvis det indeholder uigennemsigtige partikler, er misfarvet eller indeholder andre fremmedlegemer.
English: At week 8, 45 patients were randomised and received 5 mg/kg infliximab at either q8 weeks or q12 weeks as a maintenance treatment regimen.
Danish: Ved uge 8 blev 45 patienter randomiseret og fik 5 mg/kg infliximab enten hver 8. eller hver 12. uge som et vedligholdelsesregimen.
English: What Flixabi is and what it is used for What you need to know before you use Flixabi How Flixabi will be given Possible side effects
Danish: Det skal du vide, før du begynder at bruge Flixabi Sådan skal du bruge Flixabi Bivirkninger
English: Flixabi and Orencia should not be used together.
Danish: Du må ikke få Flixabi og Orencia samtidig.
English: All infliximab b
Danish: Alle infliximab b
English: If a patient shows no response after 14 weeks (i.e. after 4 doses), no additional treatment with Flixabi should be given.
Danish: Hvis en patient ikke viser respons efter 14 uger (det vil sige efter 4 doser), bør der ikke gives yderligere behandling med Flixabi.
English: Cyanosis, pericardial effusion.
Danish: Cyanose, perikardieeffusion.
English: Circulatory failure, petechia, vasospasm.
Danish: Kredsløbssvigt, petekkier, vasospasme.
English: In Group 2, starting with the week 36 infusion, patients who had a BASDAI ≥ 3 at 2 consecutive visits, received 7.5 mg/kg infliximab every 6 weeks thereafter through week 96.
Danish: Patienter i gruppe 2, som havde en BASDAI ≥ 3 ved 2 på hinanden følgende konsultationer, fik 7,5 mg/kg infliximab hver 6. uge startende med uge 36 og frem til uge 96.
English: Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn's disease (CDAI ≥ 220 ≤ 450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Danish: Infliximab med eller uden AZA blev vurderet i et randomiseret, dobbeltblind studie med aktiv komparator (SONIC) hos 508 voksne patienter med moderat til svær Crohns sygdom (CDAI ≥ 220 ≤
English: The safety and efficacy of infliximab have not been studied in children with ulcerative colitis below the age of 6 years.
Danish: Infliximabs sikkerhed og virkning hos børn under 6 år med colitis ulcerosa er ikke undersøgt.
English: In this situation, do not return to refrigerated storage again.
Danish: I tilfælde heraf må lægemidlet ikke sættes tilbage på køl.
English: Vertigo, dizziness, hypoaesthesia, paraesthesia.
Danish: Almindelig: Vertigo, svimmelhed, hypæstesi, paræstesi.
English: • Infections of the vagina.
Danish: • Infektioner i skeden.
English: There have been reports of pancytopenia, leucopenia, neutropenia, and thrombocytopenia in patients receiving TNF-blockers, including infliximab.
Danish: Der er set pancytopeni, leukopeni, neutropeni og trombocytopeni hos patienter, der fik TNF- hæmmere, herunder infliximab.
English: • Tell your doctor if you have or have ever had a problem that affects your nervous system before you are given Flixabi.
Danish: • Fortæl din læge, hvis du har eller nogensinde har haft en lidelse, som påvirker dit nervesystem,
English: After infliximab treatment, patients exhibited decreased levels of serum interleukin 6 (IL-6) and C-reactive protein (CRP), and increased haemoglobin levels in rheumatoid arthritis patients with reduced haemoglobin levels, compared with baseline.
Danish: Efter infliximab- behandling udviste patienter nedsat niveau af serum interleukin 6 (IL-6) og C-reaktiv protein (CRP).
English: • These infections may be serious and include tuberculosis, infections caused by viruses, fungi,
Danish: • Disse infektioner kan være alvorlige og indbefatter tuberkulose, infektioner forårsaget af virus, svampe, bakterier eller andre organismer i miljøet samt blodforgiftning, som kan være livstruende.
English: IMPACT
Danish: Bivirkninger
English: Flixabi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Danish: Flixabi er indiceret til behandling af moderat til svær, aktiv colitis ulcerosa hos voksne patienter, som har haft utilstrækkelig respons af konventionel behandling inklusive kortikosteroider og 6-mercaptopurin (6-MP) eller azathioprin (AZA), eller som er intolerante over for eller har kliniske kontraindikationer for sådanne behandlinger.
English: Flixabi is indicated for treatment of severe, active Crohn's disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.
Danish: Flixabi er indiceret til behandling af svær, aktiv Crohns sygdom hos børn og unge mellem 6 og 17 år, som ikke har responderet på konventionel behandling inklusive kortikosteroid, immunmodulator og primær ernæringsbehandling, eller som er intolerante over for eller hvor der er kontraindikationer mod sådanne behandlinger.
English: • The medicine will be given as an infusion (drip) (over 2 hours) into one of your veins, usually in your arm. After the third treatment, your doctor may decide to give your dose of Flixabi over 1 hour.
Danish: • Medicinenvil blive givet som en infusion (drop) (over 2 timer) i en af dine blodårer (vener),