FrancophonIA/ELRC3.0 huggingface dataset:
English: Repeated administration of infliximab (5 mg/kg at 0, 2, and 6 weeks in fistulising Crohn´'s disease, 3 or 10 mg/kg every 4 or 8 weeks in rheumatoid arthritis) resulted in a slight accumulation of infliximab in serum after the second dose.
Danish: Gentagen indgift af infliximab (5 mg/kg ved 0, 2 og 6 uger i fistulerende Crohns sygdom, 3 eller 10 mg/kg hver 4. eller 8. uge i reumatoid arthritis) resulterede i en let akkumulering af infliximab i serum efter den anden dosis.
English: For patients receiving corticosteroids at baseline, the proportion of patients in remission and not receiving corticosteroids at week 54 was 38.5% (5/13) for the q8 week and 0% (0/13) for the q12 week maintenance treatment group.
Danish: For patienter, der fik kortikosteroider ved baseline, var andelen af patienter i remission, og som ikke fik kortikosteroider ved uge 54, 38,5 % (5/13) for 8-ugers vedligeholdelsesbehandlingsgruppen og 0% (0/13) for 12-ugers vedligeholdelsesbehandlingsgruppen.
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 Zessly 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 Zessly.
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: Transvers 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: before you are given Zessly.
Danish: eller bylder (furunkulose)
English: In clinical studies, mild or moderate elevations of ALT and AST have been observed in patients receiving infliximab without progression to severe hepatic injury.
Danish: I kliniske studier er let til moderate stigninger i ALAT og ASAT set hos patienter, der fik infliximab, uden progression til alvorlig leverskade.
English: If you were using Zessly during pregnancy, tell your baby's doctor and other health care professionals caring for your baby about your Zessly use before the baby receives any vaccines.
Danish: Hvis du har fået Zessly, mens du var gravid, skal du fortælle dit barns læge og andet sundhedspersonale, der tager sig af dit barn, at du har fået Zessly, før barnet bliver vaccineret.
English: • Store in a refrigerator (2°C - 8°C).
Danish: • Opbevares i køleskab (2 °C - 8 °C)
English: AZA Monotherapy infliximab Monotherapy infliximab + AZA Combination Therapy
Danish: AZA Monoterapi infliximab Monoterapi infliximab + AZA Kombinationsterapi
English: What Zessly is and what it is used for What you need to know before you use Zessly How Zessly will be given Possible side effects
Danish: Virkning og anvendelse Det skal du vide, før du får Zessly Sådan får du Zessly
English: Overall, the adverse reactions reported in the paediatric ulcerative colitis trial and adult ulcerative colitis studies were generally consistent.
Danish: Samlet set var bivirkningerne, der blev rapporteret i studierne med colitis ulcerosa hos børn og colitis ulcerosa hos voksne overensstemmende.
English: Had treatment with any medicine containing infliximab before
Danish: Været i behandling tidligere med lægemidler, der indeholder infliximab
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 toxicitetsstudie hos mus, ved brug af det samme analoge antistof mod muse TNFα, sås krystalaflejringer på linsekapslerne hos nogle af de behandlede hanmus.
English: Do not infuse Zessly concomitantly in the same intravenous line with other agents.
Danish: Infunder ikke Zessly i den samme intravenøse slange med andre midler.
English: In the paediatric Crohn's disease study 14, 112 patients (6 to 17 years, median age 13.0 years) with moderate to severe, active Crohn's disease (median paediatric CDAI of 40) and an inadequate response to conventional therapies were to receive 5 mg/kg infliximab at weeks 0, 2, and 6.
Danish: I studie 14 med Crohns sygdom hos børn fik 112 patienter (6 til 17 år, median alder 13,0 år) med moderat til svær aktiv Crohns sygdom (median pædiatrisk CDAI på 40) og utilstrækkelig respons på konventionel behandling 5 mg infliximab/kg i ugerne 0, 2 og 6.
English: • Tell your doctor if you have or have ever had a problem that affects your nervous system before you are given Zessly.
Danish: • Fortæl din læge, hvis du har eller nogensinde har haft en lidelse, som påvirker dit nervesystem,
English: Table 5 Effects on response and remission rate in patients with moderately to severely active Crohn's disease, data from study 4 (week-2 responders)
Danish: Tabel 5 Effekter på respons og remissionshastighed hos patienter med moderat til svært aktiv Crohns sygdom, data fra studie 4 (uge-2 responderende)
English: • Some patients receiving treatment with medicines containing infliximab have developed symptoms of an immune system disorder called lupus.
Danish: • Nogle patienter, der får behandling med lægemidler, der indeholder infliximab, har udviklet symptomer på en sygdom i immunsystemet kaldet lupus.
English: The proportion of patients with infections in the paediatric ulcerative colitis trial was similar to that in the paediatric Crohn's disease study but higher than the proportion in the adults' ulcerative colitis studies.
Danish: Andelen af patienter med infektioner i studiet med colitis ulcerosa hos børn svarede til andelen i studiet med børn med Crohns sygdom, men var højere end andelen i studierne med voksne med colitis ulcerosa.
English: Efficacy and safety were assessed in two multicenter, double-blind, placebo-controlled studies in patients with active psoriatic arthritis (studies 10 and 11).
Danish: Effekt og sikkerhed blev vurderet i to dobbeltblinde, placebokontrollerede multicenterstudier hos patienter med aktiv psoriasis arthritis (studie 10 og 11).
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 aldergruppe end i den ældre aldersgruppe.
English: Concurrent administration of TNF-alpha inhibitor and abatacept
Danish: Samtidig indgift af TNF-alfahæmmer og abatacept
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000
Danish: Inden for systemorganklasserne er bivirkningerne opført under overskrifter for hyppighed ved brug af følgende kategorier: meget almindelig (≥ 1/10); almindelig
English: infliximab Maintenance 5 mg/kg (n = 113) (p value)
Danish: infliximabvedligeholdelse 5 mg/kg (n = 113) (p-værdi)
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 Zessly 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 Zesslybehandling.
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: infliximab Maintenance (5 mg/kg) (n = 96)
Danish: infliximab Vedligeholdelse (5 mg/kg) (n = 96)
English: Mucosal healing at week 30a a p < 0.001, for each infliximab treatment group vs. placebo.
Danish: Slimhindeheling i uge 30a a p < 0,001, for hver infliximab-behandlingsgruppe mod placebo.
English: Under aseptic conditions, reconstitute each Zessly 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 Zessly-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: 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 infliximab-plus methotrexatbehandlede patienter på 65 år og derover (11,3 %) sammenlignet med patienter under 65 år (4,6 %).
English: PATIENT REMINDER CARD
Danish: PATIENT-INFORMATIONSKORT
English: • More children taking infliximab developed infections as compared to adults.
Danish: • Flere børn end voksne, der får infliximab, fik infektioner.
English: The efficacy of infliximab was assessed in two multicentre, randomised, double-blind, pivotal clinical studies.
Danish: Effekten af infliximab blev vurderet i to multicenter, randomiserede, dobbeltblinde, basale kliniske studier.
English: Patients received 3 or 6 mg/kg infliximab as a 3dose 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 3 dose induktionsregi (hhv. uge 0, 2, 6 eller uge 14, 16, 20) fulgt af vedligeholdelsesbehandling hver 8. uge i kombination med methotrexat.
English: Dilute the total volume of the reconstituted Zessly solution dose to 250 ml with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: Fortynd den samlede dosis (volumen) af det rekonstituerede Zessly-koncentrat til 250 ml med natriumchlorid 9 mg/ml (0,9 %) infusionsvæske.
English: Children 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 i behandling med infliximab mod Crohns sygdom fik, var forskellige fra de bivirkninger, som voksne i behandling med infliximab mod Crohns sygdom fik.
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 maternel toksicitet, embryotoksicitet eller teratogenicitet.
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
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: Clinical Responsea Clinical Remission
Danish: Klinisk responsa Klinisk remission Steroidfri remission
English: • The other ingredients are disodium succinate hexahydrate, succinic acid, sucrose, polysorbate 80.
Danish: • Øvrige indholdsstoffer: dinatriumsuccinathexahydrat, ravsyre, saccharose, polysorbat 80.
English: PGA of cleared (0) or minimal (1) PGA of cleared (0), minimal (1), or mild (2)
Danish: PGA helt væk (0) eller minimale (1) PGA helt væk (0), minimale (1) eller lette (2)
English: Discontinuation of Zessly therapy should be considered in patients with confirmed significant haematologic abnormalities.
Danish: Seponering af Zesslybehandling bør overvejes hos patienter, hvor signifikante blodanormaliteter er bekræftet.
English: A risk for the development for hepatosplenic T-cell lymphoma in patients treated with infliximab cannot be excluded (see section 4.8).
Danish: En risiko for udvikling af hepatosplenisk T-celle-lymfom hos patienter, der bliver behandlet med infliximab, kan ikke udelukkes (se pkt.
English: The side effects that happened more in children were: low red blood cells (anaemia), blood in stool, low overall levels of white blood cells (leukopenia), redness or blushing (flushing), viral infections, low levels of white blood cells that fight infection (neutropenia), bone fracture, bacterial infection and allergic reactions of the breathing tract.
Danish: Følgende bivirkninger forekom hyppigere hos børn: nedsat antal røde blodlegemer (anæmi), blod i afføringen, nedsat samlet indhold af hvide blodlegemer (leukopeni), anfaldsvis ansigtsrødme, virusinfektioner, lavt indhold af hvide blodlegemer, der bekæmper infektion (neutropeni), knoglebrud, bakterieinfektion og allergiske reaktioner i luftvejene.
English: In the second clinical study, (study 9), 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 (studie 9) 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: Re-administration for Crohn's disease and rheumatoid arthritis If the signs and symptoms of disease recur, Zessly can be re-administered within 16 weeks following the last infusion.
Danish: Hvis tegn og symptomer på sygdom vender tilbage, kan Zessly indgives på ny inden for 16 uger efter den seneste infusion.
English: Store at 2°C - 8°C.
Danish: Opbevares ved 2 °C - 8 °C.
English: Can be stored at temperatures up to 30°C for a single period up to 6 months, but not exceeding the original expiry date.
Danish: Kan opbevares ved almindelig temperatur (op til 30 °C) i en enkelt periode på op til 6 måneder, men den oprindelige udløbsdato må ikke overskrides.
English: The efficacy of infliximab was assessed in two multicenter, randomised, double-blind studies 12 and 13.
Danish: Effekten af infliximab blev vurderet i to multicenter, randomiserede, dobbeltblinde studier: studie 12 og 13.
English: The overall incidence of infections in the paediatric ulcerative colitis trial was 13/22 (59%) in the every 8 week maintenance treatment group and 14/23 (60.9%) in the every 12 week maintenance treatment group.
Danish: Den samlede forekomst af infektioner i studiet med colitis ulcerosa hos børn var 13/22 (59 %) i 8-ugers vedligeholdelsesbehandlingsgruppen og 14/23 (60,9 %) i 12-ugers vedligeholdelsesbehandlingsgruppen.
English: The safety and efficacy of infliximab were assessed in two (studies 6 and 7) randomised, doubleblind, 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 (studie 6 og 7) 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: • 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: However, if the solution is prepared in germ-free conditions, it can be stored in a refrigerator at 2°C - 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: 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
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: • treat active Crohn's disease
Danish: • Behandle aktiv Crohns sygdom
English: • Signs of an allergic reaction such as swelling of your face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, skin rash, hives, swelling of the hands, feet or ankles.
Danish: • Tegn på en allergisk reaktion såsom hævelse af ansigt, læber, mund eller svælg, som kan forårsage besvær med at synke eller trække vejret, kløende udslæt, hævelse af hænder, fødder eller ankler.
English: 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: 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: Patients with ACR20 response/
Danish: Patienter med ACR20 respons /Patienter evalueret ( %)
English: All infliximabb
Danish: Alle infliximabb
English: New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia.
Danish: Debuterende eller forværring af allerede eksisterende psoriasis, inklusive pustuløs psoriasis (primært palmoplantaris), urticaria, udslæt, pruritus, øget svedtendens, tør hud, svampedermatitis, eksem, alopeci.
English: The safety and efficacy of infliximab were assessed in a multicenter, randomised, open-label, parallel-group clinical study 15 in 60 paediatric patients aged 6 through 17 years (median age 14.5 years) with moderately to severely active ulcerative colitis (Mayo score of 6 to 12; endoscopic subscore ≥ 2) with an inadequate response to conventional therapies.
Danish: Infliximabs sikkerhed og virkning blev vurderet i et multicenter, randomiseret, open-label, parallelgruppe klinisk studie 15 hos 60 pædiatriske patienter i alderen 6 til 17 år (medianalder 14,5 år) med moderat til svær aktiv colitis ulcerosa (Mayo-score på 6-12; endoskopisk subscore ≥ 2) med utilstrækkelig respons på konventionel behandling.
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 study 6 & study 7 data) and week 54 (21.0% vs. 8.9%, p = 0.022, study 6 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 studie 6 og studie 7 data) og uge 54 (21,0 % mod 8,9 %, p = 0,022, studie 6 data).
English: Patients received 5 mg/kg infliximab- or placebo-infusions at weeks 0, 2, and 6 followed by maintenance therapy every 8 weeks through week 22 in the placebo group and through week 46 in the infliximab group.
Danish: Patienterne fik 5 mg/kg infliximab eller placebo infusioner i uge 0, 2 og 6 efterfulgt af vedligeholdelsesbehandling hver 8. uge indtil uge 22 i placebogruppen og indtil uge 46 i infliximab-gruppen.
English: 3rd dose
Danish: 3. dosis
English: Zessly 100 mg powder for concentrate infliximab
Danish: Zessly 100 mg pulver til koncentrat infliximab
English: The following adverse reactions were reported more commonly in paediatric Crohn's disease patients (see section 5.1) than in adult Crohn's disease patients: anaemia (10.7%), blood in stool (9.7%), leukopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%).
Danish: 5.1): anæmi (10,7 %), blod i afføringen (9,7 %), leukopeni (8,7 %), rødmen (8,7 %), viral infektion (7,8 %), neutropeni (6,8 %), bakteriel infektion (5,8 %) og allergisk reaktion i luftvejene (5,8 %).
English: • Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur (see ‘Re administration' below and section 4.4).
Danish: • Fornyet indgift: Doser på 5 mg/kg, hvis sygdomstegn og symptomer på sygdommen kommer igen (se ‘Fornyet indgift' nedenfor samt pkt.
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: Zessly 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 cyclosporine, methotrexate or PUVA (see section 5.1).
Danish: Zessly 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 PUVA (se pkt.
English: In clinical studies concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections including serious infections compared to TNF-antagonists alone, without increased clinical benefit.
Danish: Samtidig anvendelse af TNF-alfahæmmere og abatacept har i kliniske studier været forbundet med en øget risiko for infektioner, inklusive alvorlige infektioner, uden en øget klinisk fordel, sammenlignet med TNF-hæmmere alene.
English: a p < 0.001, for each infliximab treatment group vs. control.
Danish: a p < 0,001, for hver infliximab-behandlingsgruppe versus kontrol.
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 (furunculosis)
Danish: • Andre hudproblemer såsom erythema multiforme, lichenoide reaktioner (kløende, rødligt-lilla hududslæt og/eller trådlignende gråhvide linjer på slimhinderne), blærer og afskalning af huden,
English: For more information see section on Pregnancy and breastfeeding.
Danish: Se afsnittet om Graviditet, amning og frugtbarhed for yderligere information.
English: Some cases of active tuberculosis have been reported in patients treated with infliximab 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 infliximab.
English: Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Zessly.
Danish: Fortæl straks din læge, hvis du får nye eller forværrede tegn på hjertesvigt under behandlingen med Zessly.
English: Other medicines and Zessly
Danish: Brug af anden medicin sammen med Zessly