FrancophonIA/ELRC3.0 huggingface dataset:
English: However, before Zessly is given to you, it is mixed with a solution that contains sodium.
Danish: Men før du får Zessly, blandes det sammen med en opløsning, som indeholder natrium.
English: The moderate number of prospectively collected pregnancies exposed to infliximab resulting in live birth with known outcomes, including approximately 1,100 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Danish: Det beskedne antal prospektivt indsamlede graviditeter eksponeret for infliximab, som resulterede i levendefødsel med kendte resultater, inklusive ca. 1.100 graviditeter, der blev eksponeret under første trimester, indikerer ikke en stigning i hyppigheden af misdannelser hos den nyfødte.
English: Dilute before use.
Danish: Fortyndes inden brug.
English: Table 6 Percent of patients with Crohn's disease achieving corticosteroid-free clinical remission at week 26
Danish: Tabel 6 Procent af patienter med Crohns sygdom, som opnåede kortikosteroidfri klinisk remission i uge 26
English: Study 3 was a randomised, multicenter, double-blind, 3-arm, parallel-group safety study.
Danish: Studie 3 var et randomiseret, multicenter, dobbelblindet, 3-armet, parallel-gruppe sikkerhedsstudie.
English: ** PASI 75 response for study 10 not included due to low N; p < 0.001 for infliximab vs. placebo at week 24 for study 11.
Danish: ** PASI 75 respons for studie 10 ikke inkluderet som følge af lav N; p < 0.001 for infliximab vs. placebo i uge 24 for studie 11.
English: Zessly should only be used in children if they are being treated for Crohn's disease or ulcerative colitis.
Danish: Zessly må kun anvendes til børn, hvis de behandles for Crohns sygdom eller colitis ulcerosa.
English: In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of Zessly (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour.
Danish: Hos nøje udvalgte voksne patienter, som har tålt mindst 3 initiale 2-timers infusioner med Zessly (induktionsfase) og får vedligeholdelsesterapi, kan det overvejes at indgive de efterfølgende infusioner over en periode på ikke mindre end 1 time.
English: • Severely decreased numbers of white blood cells have been reported in infants born to women treated with infliximab during pregnancy.
Danish: • Alvorligt fald i antal hvide blodlegemer er set hos spædbørn født af kvinder, der er blevet behandlet med infliximab under graviditeten.
English: It is important that you tell your baby's doctors and other healthcare professionals about your Zessly use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis).
Danish: Det er vigtigt, at du fortæller dit barns læger og andet sundhedspersonale, at du får Zessly, så de kan finde frem til, hvornår dit barn skal vaccineres; det gælder også levende vacciner som BCG (bruges til at forebygge tuberkulose).
English: Infusion-related reaction, pain.
Danish: Infusionsrelaterede reaktioner, smerter.
English: During treatment with Zessly
Danish: Under behandling med Zessly
English: Patients must be monitored closely for infections including tuberculosis before, during and after treatment with Zessly.
Danish: Patienter skal følges tæt for infektioner, inklusive tuberkulose før, under og efter behandling med Zessly.
English: After the first year of the study, 78 patients continued into an open-label extension to week 98.
Danish: Efter studiets første år fortsatte 78 patienter i en open-label forlængelse til uge 98.
English: The proportion of subjects who underwent colectomy at any time within 54 weeks following the first infusion of study agent were collected and pooled from study 6 and study 7 and their extensions.
Danish: Andelen af forsøgspersoner, som fik foretaget kolektomi på et hvilket som helst tidspunkt indenfor 54 uger efter den første infusion af studiemedicin, blev samlet fra studie 6 og studie 7 og deres forlængelser.
English: • reduce the number of abnormal openings (fistulae) between your bowel and your skin that have not been controlled by other medicines or surgery.
Danish: • Sænke antallet af unormale åbninger (fistler) mellem din tarm og hud, der ikke har kunnet behandles tilfredsstillende med andre lægemidler eller operation.
English: • Tell your surgeon or dentist that you are having treatment with Zessly by showing them your patient reminder card.
Danish: • Fortæl kirurgen eller tandlægen, at du er i behandling med Zessly ved at vise dem dit patientinformationskort.
English: The relative deficiency of TNFα caused by anti-TNF therapy may result in the initiation of an autoimmune process.
Danish: Den relative mangel på TNFα som følge af anti-TNF-behandling kan medføre initiering af en autoimmun proces.
English: This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Danish: Denne sjældne type af T-celle-lymfom har et meget aggressivt sygdomsforløb og er sædvanligvis fatal.
English: Patients who develop a new infection while undergoing treatment with Zessly, should be monitored closely and undergo a complete diagnostic evaluation.
Danish: Patienter, som udvikler en ny infektion, imens de er under behandling med Zessly, bør monitoreres tæt og gennemgå en komplet diagnostisk evaluering.
English: • In some patients receiving treatment with medicines containing infliximab, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
Danish: • Hos nogle patienter, som får behandling med lægemidler, der indeholder infliximab, kan kroppen måske ikke lave nok af de blodlegemer, der skal hjælpe med at bekæmpe infektioner eller stoppe blødning.
English: If these medicines do not work well enough, you will be given Zessly which you will take in combinationwith another medicine called methotrexate to:
Danish: Hvis disse lægemidler ikke virker godt nok, vil du få Zessly, som du skal tage sammen med et andet lægemiddel, der hedder methotrexat, for at:
English: All patients administered Zessly are to be observed for at least 1-2 hours post-infusion for acute infusion-related reactions.
Danish: Alle patienter, der har fået Zessly, skal observeres i mindst 1-2 timer efter infusionen for akutte infusionsrelaterede reaktioner.
English: • You may get infections more easily when you are being treated with Zessly.
Danish: • Du har lettere ved at få infektioner, når du er i behandling med Zessly.
English: • Children and adults taking Zessly may have an increased risk of developing lymphoma or another cancer.
Danish: • Børn og voksne i behandling med Zessly kan have en øget risiko for at udvikle lymfom eller anden form for kræft.
English: Date of Zessly therapy initiation:
Danish: Dato for start af Zessly-behandling:
English: Zessly works by selectively attaching to TNF alpha and blocking its action.
Danish: Zessly virker ved selektivt at binde sig til TNF alfa og blokere dets virkning.
English: • adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate.
Danish: • voksne patienter med aktiv sygdom, når responset til sygdomsmodulerende antireumatiske lægemidler (DMARDs), inklusive methotrexat, har været utilstrækkeligt.
English: In study 10 and study 11 in patients with active psoriatic arthritis, clinical responses were observed as early as week 2 and were maintained through week 98 and week 54 respectively.
Danish: I studie 10 og studie 11 hos patienter med aktiv psoriatisk arthritis blev klinisk respons observeret så tidligt som uge 2 og blev bibeholdt henholdsvis til og med uge 98 og uge 54.
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 Zessly.
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 Zessly.
English: There was no significant difference between placebo and infliximab for the proportion of patients with sustained closure of all fistulas through week 54, for symptoms such as proctalgia, abscesses and urinary tract infection or for number of newly developed fistulas during treatment.
Danish: Der var ingen signifikant forskel mellem placebo og infliximab i andelen af patienter med forlænget lukning af alle fistler til og med uge 54, med symptomer som proctalgi, abscesser og urinrørsinfektion eller i antallet af nyudviklede fistler under behandlingen.
English: Talk to your doctor before or during treatment with Zessly if you have:
Danish: Kontakt lægen, før eller under behandlingen med Zessly, hvis du har:
English: From a microbiological point of view, the product should be used as soon as possible but within 3 hours of reconstitution and dilution.
Danish: Ud fra et mikrobiologisk synspunkt bør præparatet anvendes snarest muligt, og inden for 3 timer efter rekonstituering og fortynding.
English: Zessly should only be used during pregnancy if your doctor feels it is necessary for you.
Danish: Du må kun få Zessly under graviditeten, hvis lægen finder det nødvendigt.
English: If these medicines or treatments do not work well enough, you will be given Zessly to reduce the signs and symptoms of your disease.
Danish: Hvis disse lægemidler eller behandlinger ikke virker godt nok, vil du få Zessly for at reducere tegn og symptomer på din sygdom.
English: Significant improvements in health-related quality of life were also demonstrated as measured by the physical and mental component summary scores of the SF-36 in study 11.
Danish: Signifikant forbedring i helbredsrelateret livskvalitet blev også påvist, målt med den fysiske og mentale component summary score af SF-36 i studie 11.
English: Almost all patients had also received medicines containing azathioprine or 6-mercaptopurine in addition to TNF-blockers.
Danish: Næsten alle patienterne havde også fået medicin, der indeholder azathioprin eller 6-mercaptopurin ud over den TNF-blokerende behandling.
English: What you need to know before you use Zessly You should not be given Zessly if:
Danish: Det skal du vide, før du får Zessly Du må ikke få Zessly hvis:
English: 4 years at 2°C - 8°C.
Danish: 4 år ved 2 °C - 8 °C.
English: Appropriate screening tests, (e.g. tuberculin skin test, chest X-ray, and/or Interferon Gamma Release Assay), should be performed in all patients (local recommendations may apply).
Danish: Passende screeningundersøgelser (fx tuberkulintest, røntgen af thorax og/eller Interferon Gamma Release Assay) bør udføres hos alle patienter (lokale vejledninger kan være gældende).
English: The safety and efficacy of re-administration after an infliximab-free interval of more than 16 weeks has not been established.
Danish: Sikkerhed og effekt ved fornyet indgift efter en infliximab-fri periode på over 16 uger er ikke kendt.
English: Study 4 (week-2 responders) % of Patients
Danish: Studie 4 (uge-2 responderende) % Patienter
English: Data to support dose titration in rheumatoid arthritis come from study 1, study 2 and study 3.
Danish: Data, som underbygger dosistitrering ved reumatoid arthritis, stammer fra studie 1, studie 2 og studie 3.
English: a Week 98 data for study 10 includes combined placebo crossover and infliximab patients who entered the open-label extension.
Danish: Uge 98 data for studie 10 inkluderer kombineret placebo cross-over og infliximab-patienter, der deltog i den åbne undersøgelse.
English: In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, antituberculosis therapy should be considered before the initiation of Zessly.
Danish: Hos patienter, der har adskillige eller signifikante risikofaktorer for tuberkulose og har en negativ test for latent tuberkulose, bør anti-tuberkulosebehandling overvejes før initieringen af Zessly.
English: Mucosal healing at week 8a
Danish: Slimhindeheling i uge 8a
English: • If you received Zessly while you were pregnant, your baby may also be at higher risk for getting an infection with live vaccines for up to six months after birth.
Danish: • Hvis du har fået Zessly, mens du var gravid, kan dit barn også have en større risiko for at få en infektion med levende vacciner i op til 6 måneder efter fødslen.
English: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last Zessly treatment.
Danish: Kvinder i den fertile alder skal overveje at anvende sikker antikonception for at undgå graviditet og fortsætte med anvendelsen heraf i mindst 6 måneder efter den sidste behandling med Zessly.
English: Children may receive some vaccines during treatment with Zessly but should not receive live vaccines while using Zessly.
Danish: Børn kan få visse vacciner under behandlingen med Zessly, men må ikke få levende vacciner, mens de får Zessly.
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with antituberculosis therapy before the initiation of Zessly, and in accordance with local recommendations.
Danish: Hvis inaktiv (“latent”) tuberkulose diagnosticeres, skal behandling for latent tuberkulose påbegyndes med behandling mod tuberkulose før initiering af Zesslybehandling i henhold til lokale vejledninger.
English: Zessly is available in packs containing 1, 2, 3, 4, or 5 vials.
Danish: Zessly findes i pakninger med 1, 2, 3, 4 eller 5 hætteglas.
English: There were no serious infusion reactions, and 2 subjects in the paediatric Crohn's disease study had non-serious anaphylactic reactions.
Danish: Der var ingen alvorlige infusionsreaktioner, og 2 personer i studiet med Crohns sygdom hos børn fik ikke alvorlige anafylaktiske reaktioner.
English: Zessly must be given concomitantly with methotrexate.
Danish: Zessly skal anvendes sammen med methotrexat.
English: The combination of Zessly with other biological therapeutics used to treat the same conditions as Zessly, including anakinra and abatacept, is not recommended (see section 4.4).
Danish: Kombination af Zessly og andre biologiske lægemidler anvendt til behandling af de samme lidelser som Zessly, herunder anakinra og abatacept, kan ikke anbefales (se pkt.
English: At single doses of 3, 5, or 10 mg/kg, the median Cmax values were 77, 118, and 277 micrograms/ml, respectively.
Danish: Ved enkeltdoser på 3, 5 eller 10 mg/kg var median værdier for Cmax henholdsvis 77, 118 og 277 mikrogram/ml.
English: Patients with fistulising Crohn's disease with acute suppurative fistulas must not initiate Zessly therapy until a source for possible infection, specifically abscess, has been excluded (see section
Danish: Patienter med fistulerende Crohns sygdom med akut pusdannende fistler må ikke påbegynde Zesslybehandling, før en kilde til mulig infektion, specielt abscesser, er blevet udelukket (se pkt.
English: The following side effects have been observed with medicines containing infliximab:
Danish: Følgende bivirkninger er observeret med lægemidler, der indeholder infliximab:
English: In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered medicinal product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts handelsnavn og batchnummer tydeligt registreres.
English: Zessly contains Sodium
Danish: Zessly indeholder natrium
English: In a 1-year clinical study with repeated infusions in patients with Crohn's disease, the incidence of serum sickness-like reactions was 2.4%.
Danish: I et 1-års klinisk studie med gentagne infusioner hos patienter med Crohns sygdom var hyppigheden af serumsygdoms-lignende reaktioner 2,4 %.
English: Zessly should be used with caution in patients with mild heart failure (NYHA class I/II).
Danish: Zessly bør anvendes med forsigtighed hos patienter med let hjerteinsufficiens (NYHA funktionsklasse I/II).
English: • It is recommended that when Zessly is prepared for infusion, it is used as soon as possible (within 3 hours).
Danish: • Det anbefales, at Zessly anvendes så hurtigt som muligt (inden for 3 timer), efter det er klargjort til infusion.
English: Package leaflet: Information for the user Zessly 100 mg powder for concentrate for solution for infusion infliximab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Zessly 100 mg pulver til koncentrat til infusionsvæske, opløsning infliximab Dette lægemiddel er underlagt supplerende overvågning.
English: The primary endpoints were the reduction of signs and symptoms as assessed by the American College of Rheumatology criteria (ACR20 for study 1 (described below), landmark ACR-N for study 2 (described below)), the prevention of structural joint damage, and the improvement in physical function.
Danish: De primære endepunkter var reduktionen af sygdomstegn og symptomer, i henhold til American College of Rheumatology kriterier (ACR20 for studie 1 (beskrevet nedenfor), grænsebestemt ACR-N for studie 2 (beskrevet nedenfor), forebyggelsen af strukturel ledskade og forbedringen af fysisk funktionsevne.
English: Ask your doctor to record the type and date of last screening(s) for tuberculosis (TB) below:
Danish: Du skal bede din læge om at notere type og dato for seneste screening(er) for tuberkulose (TB) nedenfor:
English: Use of antituberculosis therapy should also be considered before the initiation of Zessly in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Danish: Anvendelsen af anti-tuberkulosebehandling bør også overvejes før initieringen af Zessly hos patienter med en tidligere sygdomshistorie med latent eller aktiv tuberkulose, hos hvem et passende behandlingsprogram ikke kan bekræftes.
English: • These infections may be serious and include tuberculosis, infections caused by viruses, fungi, bacteria or other organisms in the environment and sepsis that may be life-threatening.
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: Zessly may have a minor influence on the ability to drive and use machines.
Danish: Zessly påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Vaccine breakthrough infection (after in utero exposure to infliximab)*.
Danish: Gennembrudsinfektion efter vaccination (efter eksponering for infliximab i uterus)*
English: Analysis of lamina propria mononuclear cells obtained by biopsy of the intestinal mucosa showed that infliximab treatment caused a reduction in the number of cells capable of expressing TNFα and interferonγ.
Danish: Analyse af lamina propria mononukleære celler udtaget ved biopsi fra den intestinale mucosa viste, at infliximab-behandling forårsagede en reduktion i antallet af celler, som var i stand til at udtrykke TNFα og interferonγ.
English: Do not use Zessly if any of the above applies to you.
Danish: Du må ikke få Zessly, hvis noget af ovenstående passer på dig.
English: In most fistulising Crohn's disease patients, infliximab was detected in serum for 12 weeks (range 4-28 weeks) after administration of the regimen.
Danish: I de fleste patienter med fistulerende Crohns sygdom blev infliximab påvist i serum i 12 uger (interval 4-28 uger) efter indgift af regimen.
English: Administration of Zessly should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Danish: Behandling med Zessly bør seponeres, hvis en patient udvikler en ny alvorlig infektion eller sepsis, og passende antimikrobiel eller antimykotisk behandling bør initieres, indtil infektionen er under kontrol.
English: The efficacy of infliximab through week 54 was assessed in study 6.
Danish: Effekten af infliximab i uge 54 blev undersøgt i studie 6.
English: During Zessly treatment, other concomitant therapies, e.g. corticosteroids and immunosuppressants should be optimised.
Danish: Under Zesslybehandling bør anden samtidig behandling såsom kortikosteroider og immunsuppressiva optimeres.
English: It is recommended that patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating infliximab therapy.
Danish: Det anbefales, at patienterne, om muligt, bringes up to date med alle vaccinationer i overensstemmelse med gældende vaccinationsvejledninger før initiering af behandling med infliximab.
English: ≥ 5 x ULN placebo infliximab placebo infliximab placebo infliximab placebo infliximab
Danish: placebo infliximab placebo infliximab placebo infliximab placebo infliximab
English: 6 weeks after your 1st treatment
Danish: 6 uger efter din 1. dosis
English: Contents of the pack and other information What Zessly contains
Danish: Pakningsstørrelser og yderligere oplysninger Zessly indeholder
English: • Tell your doctor before you are given Zessly if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
Danish: • Fortæl din læge, før du får Zessly, hvis du har eller nogensinde har haft lymfom (en type blodkræft) eller enhver anden form for kræft.
English: • A reminder to patients to show the patient reminder card to all treating HCPs, including in conditions of emergency, and a message for HCPs that the patient is using Zessly
Danish: • En påmindelse til patienterne om, at de skal vise patientinformationskortet til alle behandlende sundhedspersoner, herunder i nødstilfælde, og en besked til sundhedspersoner om, at patienten anvender Zessly.
English: • Children should receive recommended vaccinations before starting Zessly treatment.
Danish: • Børn skal have de anbefalede vaccinationer, før behandling med Zessly påbegyndes.
English: If jaundice and/or ALT elevations ≥ 5 times the upper limit of normal develop(s), Zessly should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Danish: Hvis der opstår gulsot og/eller ALAT-forhøjelser ≥ 5 gange øvre grænse af normalområdet, bør Zessly seponeres, og et omhyggelig studie af hændelsen bør foretages.
English: The potential risk with the combination of AZA or 6-MP and Zessly should be carefully considered.
Danish: Den potentielle risiko ved kombinationen af AZA eller 6-MP og Zessly bør overvejes omhyggeligt.
English: The requirements for submission of PSUR for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: • If you received Zessly during your pregnancy, your baby may have a higher risk for getting an infection.
Danish: • Hvis du fik Zessly under graviditeten, kan dit barn have en øget risiko for at få en infektion.
English: Reduction in CDAI ≥ 25% and ≥ 70 points.
Danish: Vedblivende steroidfri remissionb a Reduktion i CDAI ≥ 25 % og ≥ 70 point.
English: If you received Zessly while pregnant, giving BCG vaccine (used to prevent tuberculosis) to your baby within 6 months after birth may result in infection with serious complications, including death.
Danish: Hvis du har fået Zessly under graviditeten, kan vaccination af dit barn med BCG-vaccine (bruges til at forebygge tuberkulose) inden for 6 måneder efter fødslen medføre infektion med alvorlige komplikationer herunder død.
English: Infliximab inhibits the functional activity of TNFα in a wide variety of in vitro bioassays.
Danish: Infliximab hæmmer den funktionelle aktivitet af TNFα i en lang række forskellige in vitro bioassays.