FrancophonIA/ELRC3.0 huggingface dataset:
English: Flixabi is supplied as a glass vial containing a powder for concentrate for solution for infusion.
Danish: Flixabi leveres som et hætteglas (glasflaske) indeholdende et pulver til koncentrat til infusionsvæske, opløsning.
English: However, if the solution is prepared in germ-free conditions, it can be stored in a refrigerator at 2°C to 8°C for 24 hours.
Danish: Hvis opløsningen er klargjort under aseptiske betingelser, kan den dog opbevares i køleskab ved 2 °C - 8 °C i 24 timer.
English: • Children should receive recommended vaccinations before starting Flixabi treatment.
Danish: • Børn skal have de anbefalede vaccinationer, før behandling med Flixabi påbegyndes.
English: If you were using Flixabi during pregnancy, tell your baby's doctor and other healthcare professionals caring for your baby about your Flixabi use before the baby receives any vaccines.
Danish: Hvis du har fået Flixabi, mens du var gravid, skal du fortælle dit barns læge og andet sundhedspersonale, der tager sig af dit barn, at du har fået Flixabi, før barnet bliver vaccineret.
English: In an exploratory clinical study evaluating the use of infliximab in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies were reported in infliximab-treated patients compared with control patients.
Danish: I et uddybende klinisk studie, der vurderede anvendelsen af infliximab hos patienter med moderat til svær kronisk obstruktiv lungesygdom (COPD), blev der rapporteret flere maligne sygdomme hos patienter behandlet med infliximab sammenlignet med kontrolpatienter.
English: • That treatment with Flixabi 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 Flixabi 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: Children and adolescents who took infliximab for Crohn's disease showed some differences in side effects compared with adults who took infliximab for Crohn's disease.
Danish: De bivirkninger, som børn og unge i behandling med infliximab mod Crohns sygdom fik, var forskellige fra de bivirkninger, som voksne i behandling med infliximab mod Crohns sygdom fik.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing infliximab in all subsets of the paediatric population in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis and Crohn's disease (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med referencelægemidlet, som indeholder infliximab, i alle undergrupper af den pædiatriske population med reumatoid arthritis, juvenil idiopatisk arthritis, psoriasis arthritis, ankyloserende spondylitis, psoriasis og Crohns sygdom (se pkt.
English: Abnormal skin openings • Tell your doctor if you have any abnormal skin openings (fistulae) before you are given Flixabi.
Danish: Unormale hudåbninger • Fortæl din læge, hvis du har nogen unormale hudåbninger (fistler), før du får Flixabi.
English: Among patients in the infliximab 5 mg/kg group who crossed over because of loss of fistula response after week 22, 57% (12/21) responded to re-treatment with infliximab 10 mg/kg every 8 weeks.
Danish: Blandt patienter i infliximabgruppen 5 mg/kg, der krydsede over på grund af tab af fistula respons efter uge 22, responderede 57 % (12/21) på genbehandling med infliximab 10 mg/kg hver 8. uge.
English: Children may receive some vaccines during treatment with Flixabi but should not receive live vaccines while using Flixabi.
Danish: Børn kan få visse vacciner under behandlingen med Flixabi, men må ikke få levende vacciner,
English: Gently swirl the solution by rotating the vial to dissolve the lyophilised powder.
Danish: Bland forsigtigt opløsningen ved at slynge hætteglasset rundt for at opløse det lyofiliserede pulver.
English: • Tell your doctor before you are given Flixabi if you are a carrier of hepatitis B or have ever had it.
Danish: • Fortæl din læge, før du får Flixabi, hvis du er bærer af hepatitis B, eller hvis du nogensinde har haft det.
English: • Some patients receiving infliximab have developed serious liver problems.
Danish: • Nogle patienter, der får infliximab, har udviklet alvorlige leverproblemer.
English: Infliximab 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 infliximab 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: There have been reports of active tuberculosis in patients receiving infliximab.
Danish: Der er set tilfælde af aktiv tuberkulose hos patienter behandlet med infliximab.
English: In SPIRIT, the proportion of patients achieving PASI 75 at week 10 was 71.7% in the 3 mg/kg infliximab group, 87.9% in the 5 mg/kg infliximab group, and 5.9% in the placebo group (p < 0.001).
Danish: I SPIRIT var andelen af patienter, der opnåede PASI 75 i uge 10 71,7 % i 3 mg/kg infliximab- gruppen, 87,9 % i 5 mg/kg infliximab-gruppen og 5,9 % i placebogruppen (p < 0,001).
English: Flixabi may be stored at temperatures up to a maximum of 25°C for a single period of up to 6 months, but not exceeding the original expiry date.
Danish: Flixabi kan opbevares ved temperaturer på maksimalt 25 °C i en enkelt periode på op til 6 måneder, som ikke overskrider den oprindelige udløbsdato.
English: • You are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for infliximab (det aktive indholdsstof i Flixabi) eller et af de øvrige indholdsstoffer i Flixabi (angivet i punkt 6),
English: While the numbers of patients in each subgroup are too small to make any definitive conclusions about the effect of age on safety events, there were higher proportions of patients with serious adverse events and discontinuation due to adverse events in the younger age group than in the older age group.
Danish: Antallet af patienter i hver undergruppe er for lille til at drage definitive konklusioner om alderens indflydelse på bivirkninger, men der var en større andel af patienter med alvorlige bivirkninger og patienter, som stoppede behandlingen på grund af bivirkninger, i den yngre aldersgruppe end i den ældre aldersgruppe.
English: The safety and efficacy of infliximab were assessed in two (ACT 1 and ACT 2) randomised, double-blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6-MP, AZA)].
Danish: Sikkerhed og effekt ved infliximab blev vurderet i to (ACT 1 og ACT 2) randomiserede, dobbeltblinde, placebokontrollerede kliniske studier hos voksne patienter med moderat til svær, aktiv colitis ulcerosa (Mayo-score 6 til 12; Endoskopi subscore ≥ 2) med et utilstrækkeligt respons på konventionel behandling [orale kortikosteroider, aminosalicylater og/eller immunmodulatorer (6-MP, AZA)].
English: Flixabi is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Danish: Flixabi er indiceret til behandling af svær, aktiv ankyloserende spondylitis hos voksne patienter, som har responderet utilstrækkeligt på konventionel behandling.
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: Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, ATTRACT
Danish: Tabel 3 Virkninger på ACR20, strukturel ledskade og fysisk funktionsevne ved uge 54, ATTRACT infliximab b
English: In a 6-month repeated dose toxicity study in mice, using the same analogous antibody against mouse TNFα, crystalline deposits were observed on the lens capsule of some of the treated male mice.
Danish: I et 6-måneders flerdosis toksicitetsstudie hos mus, ved brug af det samme analoge antistof mod muse TNFα, sås krystalaflejringer på linsekapslerne hos nogle af de behandlede hanmus.
English: What you need to know before you use Flixabi
Danish: Det skal du vide, før du begynder at bruge Flixabi
English: • You are allergic (hypersensitive) to proteins that come from mice.
Danish: • hvis du er allergisk over for proteiner, som stammer fra mus,
English: Transverse myelitis, central nervous system demyelinating disorders (multiple sclerosis-like disease and optic neuritis), peripheral demyelinating disorders (such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy).
Danish: Transversel myelitis, demyeliniseringsforstyrrelser i centralnervesystemet (dissemineret sklerose-lignende sygdom og optisk neuritis), perifere demyeliniseringsforstyrrelser (såsom Guillain-Barré syndrom, kronisk inflammatorisk demyeliniserende polyneuropati og multifokal motorisk neuropati).
English: For women taking infliximab including those over 60 years of age, your doctor may recommend regular screening for cervical cancer.
Danish: Lægen kan tilråde, at kvinder, der får infliximab, herunder kvinder over 60 år, bliver regelmæssigt screenet for livmoderhalskræft.
English: Patients received 3 or 6 mg/kg infliximab as a 3-dose induction regimen (weeks 0, 2, 6 or weeks 14, 16, 20, respectively) followed by maintenance therapy every 8 weeks, in combination with methotrexate.
Danish: Patienterne fik 3 eller 6 mg/kg infliximab som et induktionsregimen med 3 doser (hhv. uge 0, 2, 6 eller uge 14, 16, 20) fulgt af vedligeholdelsesbehandling hver 8. uge i kombination med methotrexat.
English: All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g. persistent cough, wasting/weight loss, low-grade fever) appear during or after Flixabi treatment.
Danish: Alle patienter skal informeres om at søge læge, hvis sygdomstegn/symptomer, der tyder på tuberkulose (fx vedvarende hoste, skranten/vægttab, let feber), forekommer under eller efter Flixabibehandling.
English: In both studies concurrent use of stable doses of folic acid, oral corticosteroids (≤ 10 mg/day) and/or non-steroidal anti-inflammatory drugs (NSAIDs) was permitted.
Danish: I begge studier var samtidig brug af konstante doser af folinsyre, orale kortikosteroider (≤ 10 mg/dag) og/eller nonsteroide anti-inflammatoriske stoffer (NSAIDs) tilladt.
English: No physical biochemical compatibility studies have been conducted to evaluate the co-administration of Flixabi with other agents.
Danish: Der er ikke gennemført biokemiske forligelighedsstudier for at vurdere samtidig indgivelse af Flixabi med andre midler.
English: In rheumatoid arthritis clinical studies, the incidence of serious infections was greater in infliximab plus methotrexate-treated patients 65 years and older (11.3%) than in those under 65 years of age (4.6%).
Danish: I kliniske studier af reumatoid arthritis var hyppigheden af alvorlige infektioner højere hos infliximabplus methotrexatbehandlede patienter på 65 år og derover (11,3 %) sammenlignet med patienter under 65 år (4,6 %).
English: If these medicines do not work well enough, you will be given Flixabi to:
Danish: Hvis disse lægemidler ikke virker godt nok, vil du få Flixabi for at:
English: Thrombocytopenia, lymphopenia, lymphocytosis.
Danish: Trombocytopeni, lymfopeni, lymfocytose.
English: Date of Flixabi therapy initiation:
Danish: Dato for start af Flixabi-behandling:
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age), including infliximab in the post-marketing setting.
Danish: Efter markedsføring er der rapporteret maligniteter, hvoraf nogle har været letale, hos børn, unge og unge voksne (op til 22 år), som er behandlet med TNF-blokkere inklusive infliximab (behandlingsstart før 18-års alderen).
English: Tumour necrosis factor alpha (TNFα) mediates inflammation and modulates cellular immune responses.
Danish: Tumor nekrose faktor alfa (TNFα) frembringer betændelse og modulerer cellulært immunrespons.
English: There is limited safety experience of infliximab treatment in patients who have undergone surgical procedures, including arthroplasty.
Danish: Der er begrænset erfaring med sikkerheden af infliximab-behandling hos patienter, som har gennemgået kirurgiske indgreb inklusive atroplastik.
English: Week 50
Danish: Uge 50
English: In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of Flixabi therapy.
Danish: Hos patienter med allerede eksisterende eller nyligt opståede demyeliniseringssygdomme skal vurdering af forventet gavn og risiko ved anti-TNF-behandlingen overvejes omhyggeligt før initiering af behandling med Flixabi.
English: If active tuberculosis is diagnosed, Flixabi therapy must not be initiated (see section 4.3).
Danish: Ved aktiv tuberkulose, må Flixabibehandling ikke påbegyndes (se pkt.
English: Efficacy and safety were assessed in two multicentre, double-blind, placebo-controlled studies in patients with active psoriatic arthritis.
Danish: Effekt og sikkerhed blev vurderet i to dobbeltblinde, placebokontrollerede multicenterstudier hos patienter med aktiv psoriasis arthritis.
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.
Danish: I et toksicitetsstudie vedrørende udvikling udført på mus ved brug af et analogt antistof, der selektivt hæmmer den funktionelle aktivitet af muse TNFα, var der ingen tegn på maternal toksicitet, embryotoksicitet eller teratogenicitet.
English: The most serious ADRs associated with the use of TNF blockers that have been reported for infliximab include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, paediatric malignancy, sarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn's disease), and serious infusion reactions (see section 4.4).
Danish: De alvorligste bivirkninger forbundet med brugen af TNF-blokkere, som er blevet rapporteret for infliximab, inkluderer HBV-reaktivering, CHF (kongestivt hjertesvigt), alvorlige infektioner (inklusive sepsis, opportunistiske infektioner og TB), serumsygdom (forsinkede overfølsomhedsreaktioner), hæmatologiske reaktioner, systemisk lupus erythematosus/lupus-lignende syndrom, demyeliniserende sygdomme, hepatobiliære bivirkninger, lymfomer, HSTCL, leukæmi, Merkelcellekarcinom, melanom, pædiatrisk malignitet, sarkoidose/sarkoid-lignende reaktion, byld i tarmen eller ved endetarmen (ved Crohns sygdom) og alvorlige infusionsreaktioner (se pkt.
English: The concurrent administration of live vaccines with Flixabi is not recommended.
Danish: Samtidig administration af levende vacciner og Flixabi frarådes.
English: • Tell your doctor before you are given Flixabi if you have a lung disease called Chronic Obstructive Pulmonary Disease (COPD) or if you are a heavy smoker.
Danish: • Fortæl din læge, før du får Flixabi, hvis du har en lungesygdom kaldet kronisk obstruktiv lungesygdom (KOL, rygerlunger), eller hvis du er storryger.
English: Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation.
Danish: Gastrointestinal blødning, diarré, dyspepsi, gastroøsofageal refluks, forstoppelse.
English: • If your doctor feels that you are at risk for TB, you may be treated with medicines for TB before you are given Flixabi.
Danish: • Hvis din læge tror, at du har risiko for at få TB, kan du blive behandlet med lægemidler mod TB,
English: Flixabi is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: Flixabi fortyndes dog med natriumchlorid 9 mg/ml (0,9%) infusionsvæske, opløsning.
English: At week 30, the proportion of subjects in clinical remission was higher in the q8 week (59.6%, 31/52) than the q12 week maintenance treatment group (35.3%, 18/51; p=0.013).
Danish: I uge 30 var andelen af personer med klinisk remission højere i 8-ugers gruppen (59,6 %; 31/52) end i 12-ugers gruppen (35,3 %, 18/51; p = 0,013).
English: Currently available pharmacokinetic data are described in section 5.2 but no recommendation on a posology can be made in children younger than 6 years.
Danish: 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering hos børn under 6 år.
English: Do not infuse Flixabi concomitantly in the same intravenous line with other agents.
Danish: Infunder ikke Flixabi i den samme intravenøse slange med andre midler.
English: b a A ≥ 50% reduction from baseline in the number of draining fistulas over a period of ≥ 4 weeks b Absence of any draining fistulas
Danish: Komplet fistula respons (%)b a A ≥ 50 % reduktion fra baseline i antallet af drænede fistulaer over en periode på ≥ 4 uger.
English: Under aseptic conditions, reconstitute each Flixabi vial with 10 ml of water for injections, using a syringe equipped with a 21-gauge (0.8 mm) or smaller needle.
Danish: Rekonstituer under aseptiske forhold hvert Flixabi-hætteglas med 10 ml vand til injektionvæsker ved hjælp af en sprøjte med en gauge 21 (0,8 mm) kanyle eller en mindre kanyle.
English: If these medicines do not work well enough, you will be given Flixabi to treat your disease.
Danish: Hvis disse lægemidler ikke virker godt nok, vil du få Flixabi til behandling af din sygdom.
English: During treatment with Flixabi
Danish: Under behandling med Flixabi
English: Percentage of subjects in clinical response and in sustained clinical response Clinical response at week 8
Danish: Procent forsøgspersoner i klinisk respons og i vedvarende klinisk respons Klinisk respons i uge 8a
English: Seizure, neuropathy.
Danish: Ikke almindelig: Kramper, neuropati.
English: Vaccine breakthrough infection (after in utero exposure to infliximab) Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare:
Danish: Gennembrudsinfektion efter vaccination (efter eksponering for infliximab i uterus)* Benigne, maligne og uspecificerede tumorer (inkl.
English: Percentage of subjects in clinical remission and sustained remission Clinical remission at week 8
Danish: Procent forsøgspersoner i klinisk remission og vedvarende remission Klinisk remission i uge 8a
English: Infliximab Maintenance (5 mg/kg) (n=96)
Danish: Infliximab Vedligeholdelse (5 mg/kg) (n = 96)
English: • Infections due to a weakened immune system
Danish: • Infektioner, som skyldes et nedsat immunforsvar
English: Infliximab + AZA Combination therapy
Danish: Infliximab + AZA Kombinationsterap i
English: Table 5 Effects on response and remission rate, data from ACCENT I (week-2 responders)
Danish: Tabel 5 Effekter på respons og remissionshastighed, data fra ACCENT I (uge-2 responderende) ACCENT I (uge-2 responderende) % patienter
English: • Treat active Crohn's disease,
Danish: • Behandle aktiv Crohns sygdom
English: Placebo Maintenance (n=110)
Danish: Placebovedligeholdelse (n = 110)
English: Flixabi should only be used during pregnancy if your doctor feels it is necessary for you.
Danish: • Du må kun få Flixabi under graviditeten, hvis lægen finder det nødvendigt.
English: If you are 65 or older,
Danish: Du har en højere risiko, hvis du er 65 år eller derover.
English: • Signs of a nervous system problem (including eye problems) such as signs of a stroke (sudden numbness or weakness of your face, arm or leg, especially on one side of your body; sudden confusion, trouble speaking or understanding; trouble seeing in one or both eyes, trouble walking, dizziness, loss of balance or coordination or a severe headache), fits, tingling/numbness in any part of your body, or weakness in arms or legs, changes in eyesight such as double vision or other eye problems
Danish: Tegn på lungeproblemer såsom hoste, åndedrætsbesvær eller trykken for brystet Tegn på et problem i nervesystemet (inklusive øjenproblemer) såsom tegn på slagtilfælde (pludselig følelsesløshed eller svaghed i ansigt, arme eller ben, særligt i den ene side af kroppen; pludselig forvirring, besvær med at tale eller forstå; besvær med at se med det ene eller begge øjne, gangbesvær, svimmelhed, tab af balance- eller koordinationsevne eller svær hovedpine), krampeanfald, prikken/følelsesløshed et sted i kroppen, eller svaghed i arme eller ben, ændringer i synet såsom dobbeltsyn eller andre øjenproblemer.
English: In the second clinical study (ASSERT), 279 patients were randomised to receive either placebo (Group 1, n=78) or 5 mg/kg infliximab (Group 2, n=201) at 0, 2 and 6 weeks and every 6 weeks to week 24.
Danish: I det andet kliniske studie (ASSERT) blev 279 patienter randomiseret til behandling med enten placebo (gruppe 1, n = 78) eller 5 mg/kg infliximab (gruppe 2, n = 201) i uge 0, 2 og 6 og derefter hver 6. uge indtil uge 24.
English: Bullous eruption, seborrhoea, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation.
Danish: Bulløst udslæt, seborre, rosacea, hudpapilom, hyperkeratose, unormal hudpigmentering.
English: Dilute the total volume of the reconstituted Flixabi solution dose to 250 ml with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: Fortynd det samlede volumen af den rekonstituerede dosis Flixabi-opløsning til 250 ml med natriumchlorid 9 mg/ml (0,9 %) infusionsvæske, opløsning.
English: Live vaccines such as BCG should not be given to your baby within 6 months after birth.
Danish: Dit barn bør ikke få levende vacciner som BCG indenfor 6 måneder efter fødslen.
English: Induction treatment in moderately to severely active Crohn's disease The efficacy of a single dose treatment with infliximab was assessed in 108 patients with active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) in a randomised, double-blinded, placebocontrolled, dose-response study.
Danish: Induktionsbehandling af moderat til svært aktiv Crohns sygdom Effekten af en enkeltdosisbehandling med infliximab blev vurderet hos 108 patienter med aktiv Crohns sygdom (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) i et randomiseret, dobbeltblind,
English: Abdominal pain, nausea.
Danish: Meget almindelig: Abdominalsmerter, kvalme.
English: Clinical response at week 30
Danish: Klinisk respons i uge 30a