FrancophonIA/ELRC3.0 huggingface dataset:
English: If you received Cyltezo while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy.
Danish: Hvis du har fået Cyltezo under din graviditet, kan dit spædbarn have en højere risiko for at få en infektion i op til ca. fem måneder efter din sidste dosis under graviditeten.
English: Patients on Cyltezo may receive concurrent vaccinations, except for live vaccines.
Danish: Patienter i Cyltezo-behandling kan modtage samtidige vaccinationer, undtagen med levende vacciner.
English: Prior to launch of Cyltezo in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Før Cyltezo markedsføres i hvert medlemsland skal indehaveren af markedsføringstilladelsen nå til enighed med den nationale kompetente myndighed om indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmedier, udleveringskanaler samt alle andre aspekter af programmet.
English: If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Danish: Hvis der er mistanke om latent tuberkulose, bør en læge med ekspertise i behandling af tuberkulose
English: In CD Study III, at week 4, 58 % (499/854) of patients were in clinical response and were assessed in the primary analysis.
Danish: I CD-studie III havde 58 % (499/854) af patienterne klinisk respons i uge 4 og blev vurderet i den primære analyse.
English: • As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Cyltezo.
Danish: • Eftersom der har været indberettet tilfælde af tuberkulose hos patienter i behandling med adalimumab, vil lægen undersøge dig for tegn og symptomer på tuberkulose, før behandling med Cyltezo påbegyndes.
English: A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e. not identical to the TSS used for rheumatoid
Danish: Der blev anvendt en modificeret Total Sharp-score (mTSS), som medtog distale interfalangealled (dvs. ikke identisk med den TSS, som anvendes ved reumatoid artritis).
English: Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as nonresponders.
Danish: Patienter, som opfyldte protokol-specifikke kriterier for tab af respons eller ingen forbedring, udgik af studierne og blev
English: The injection button will unlock and be ready for use.
Danish: Injektionsknappen vil låse op, og være
English: Each pack contains 1, 2, 4 or 6 pre-filled syringes for patient use with 2, 2, 4 or 6 alcohol pads, respectively.
Danish: Hver pakning indeholder 1, 2, 4 eller 6 fyldte injektionssprøjter til patientbrug med henholdsvis 2, 2, 4 eller 6 alkoholservietter.
English: • If you have mild heart failure and you are being treated with Cyltezo, your heart failure status must be closely monitored by your doctor.
Danish: • Hvis du har lettere hjerteinsufficiens og bliver behandlet med Cyltezo, skal status for din hjerteinsufficiens følges nøje af din læge.
English: • If you have or develop a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Cyltezo.
Danish: • Hvis du har eller udvikler en demyeliniserende sygdom (en sygdom, der påvirker det isolerende lag rundt om nerverne, såsom dissemineret sklerose) vil din læge afgøre, om du skal have eller fortsætte med at få Cyltezo.
English: 2) Inspect pen
Danish: 2) Inspicer pennen
English: Cyltezo should be used with caution in patients with mild heart failure (NYHA class I/II).
Danish: Cyltezo bør anvendes med forsigtighed til patienter med let hjerteinsufficiens (NYHA, klasse I/II).
English: Paediatric CD Study PCDAI Clinical Remission and Response
Danish: Pædiatrisk CD-studie PCDAI klinisk remission og respons
English: Hypersensitivity, allergies (including seasonal allergy)
Danish: Hypersensitivitet, allergier (inklusive sæsonbestemt
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Cyltezo is a biosimilar medicinal product.
Danish: Cyltezo er et biosimilært lægemiddel.
English: • Only use each pre-filled pen for one injection.
Danish: • Brug kun hver fyldte pen til én injektion.
English: This may cause severe allergic reactions in patients sensitive to latex.
Danish: Dette kan medføre svære allergiske reaktioner hos patienter med latexsensibilitet.
English: The pre-filled syringe/pre-filled pen must be protected from light, and discarded if not used within the 14-day period.
Danish: Den fyldte injektionssprøjte/fyldte pen skal beskyttes mod lys og kasseres, hvis den ikke anvendes inden for 14-dages perioden.
English: The symptoms described above can be signs of the below listed side effects, which have been observed with
Danish: Ovennævnte symptomer kan være tegn på følgende bivirkninger, som er observeret ved brug af
English: • If you have moderate or severe heart failure.
Danish: • hvis du lider af moderat til alvorlig hjerteinsufficiens.
English: • severe rash, hives or other signs of allergic reaction;
Danish: • alvorligt udslæt, nældefeber eller andre tegn på en allergisk reaktion
English: If you take Cyltezo the risk of getting lymphoma, leukaemia, or other cancers may increase.
Danish: Når du tager Cyltezo, kan din risiko for at få et lymfom, leukæmi eller andre former for kræft øges.
English: The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above.
Danish: Målet for adalimumab er et protein, der kaldes tumornekrosefaktor (TNFα), som er til stede i øget mængde ved ledbetændelsessygdommene anført ovenfor.
English: Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0 - 10; 0 = no skin pain, 10 = skin pain as bad as you can imagine
Danish: Blandt patienter med HS-relateret evaluering af hudsmerte ≥ 3 ved baseline, baseret på en numerisk vurderingsskala 0-10; 0 = ingen hudsmerte, 10 = hudsmerte så slem, som du kan forestille dig.
English: If retreatment with adalimumab is indicated, the above guidance on dose and treatment duration should be followed.
Danish: Hvis genbehandling med adalimumab er indiceret, bør ovenstående vejledning for dosering og
English: The efficacy and safety of adalimumab were assessed in five randomised, double-blind and well-controlled studies.
Danish: Adalimumabs virkning og sikkerhed blev vurderet i fem randomiserede, dobbeltblindede og velkontrollerede studier.
English: • Use alcohol wipe to clean selected injection site.
Danish: • Anvend en alkoholserviet for at rengøre det valgte injektionssted.
English: Administration of Cyltezo 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: Administration af Cyltezo bør ophøre, hvis en patient udvikler en ny alvorlig infektion eller sepsis, og passende antimikrobiel eller antimykotisk behandling iværksættes, indtil infektionen er under kontrol.
English: It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Cyltezo.
Danish: Det anbefales, at børn får alle de planlagte vaccinationer for deres alder, før de starter behandlingen med Cyltezo.
English: • Before removing pen from skin, confirm entire dose was delivered by making sure plunger (seen in
Danish: • Før pennen fjernes fra huden, skal det bekræftes, at hele dosis blev leveret ved at sikre, at stemplet (set i vinduet) er nået til bunden af pennen.
English: Therapy continued beyond 12 weeks did not result in significantly more responses (see section 4.2).
Danish: Behandling efter uge 12 resulterede ikke i signifikant flere respondenter (se pkt.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG
English: After proper training in injection technique, patients may self-inject with Cyltezo if their physician determines that it is appropriate and with medical follow-up as necessary.
Danish: Efter passende oplæring i injektionsteknik kan patienter selv injicere Cyltezo, såfremt lægen finder det hensigtsmæssigt, og med nødvendig lægelig opfølgning.
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for
Danish: • Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: - Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given Cyltezo and during treatment with Cyltezo.
Danish: - Din læge vil også udlevere et patientkort, der indeholder vigtige sikkerhedsinformationer, som du skal være opmærksom på før og under din behandling med Cyltezo.
English: Adalimumab is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Danish: Adalimumab bruges til at behandle Crohns sygdom hos voksne og børn i alderen 6 til 17 år.
English: Seek medical attention urgently, if you notice any of the following:
Danish: Søg akut lægehjælp, hvis du får følgende symptomer:
English: Significant response was first observed at week 2 and maintained through 24 weeks (Table 13).
Danish: Første signifikante respons blev observeret ved uge 2 og blev opretholdt frem til uge 24
English: The results for the 40 mg every other week dose are summarised in Table 7.
Danish: Resultaterne for en dosis på 40 mg hver anden uge er opstillet i tabel 7.
English: Ps Study I (REVEAL) - Efficacy Results at 16 Weeks
Danish: Ps-studie I (REVEAL) Virkningsresultater ved uge 16
English: At week 4, subjects were randomised 1:1 based on their body weight at the time to either the Low Dose or Standard Dose maintenance regimens as shown in Table 25.
Danish: Ved uge 4 blev patienterne på basis af deres legemsvægt på det tidspunkt randomiseret 1:1 til enten lavdosis- eller standarddosis-vedligeholdelsesregime som vist i tabel 25.
English: The percent of adalimumab-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
Danish: Procentdelen af adalimumab-behandlede patienter, der fik ACR 20-, 50- og 70-respons, var konsistent mellem RA-studie I, II og III.
English: Thus, it is not possible to use Cyltezo for children who require less than a full 40 mg dose.
Danish: Det er derfor ikke muligt at bruge Cyltezo til børn, som har behov for mindre end en fuld 40 mg dosis.
English: The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at week 52.
Danish: Det primære endepunkt i RA-studie V var procentdelen af patienter, som opnåede et ACR 50 respons i uge 52.
English: People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system), and leukaemia (a cancer that affects the blood and bone marrow).
Danish: Patienter med mere alvorlig reumatoid artrit, som har haft sygdommen i lang tid, kan have øget risiko i forhold til gennemsnittet for at få lymfomer (en kræfttype, som påvirker lymfesystemet) og leukæmi (en kræfttype, som påvirker blod og knoglemarv).
English: Treatment with Cyltezo should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Danish: Behandling med Cyltezo bør ikke initieres hos patienter med aktive infektioner, herunder kroniske eller lokaliserede infektioner, før infektionerne er under kontrol.
English: In subjects treated with adalimumab with no radiographic progression from baseline to week 48 (n = 102), 84 % continued to show no radiographic progression through 144 weeks of treatment.
Danish: Af de forsøgspersoner, som blev behandlet med adalimumab uden at vise progression radiografisk fra baseline til uge 48 (n = 102), viste 84 % fortsat ingen progression radiografisk i løbet af de 144 ugers behandling.
English: Cyltezo is intended for the treatment of the inflammatory diseases described below: • Polyarticular juvenile idiopathic arthritis,
Danish: Cyltezo er beregnet til behandlingen af de inflammatoriske sygdomme beskrevet nedenfor: • Polyartikulær juvenil idiopatisk artrit,
English: In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see Tables 17 and 18).
Danish: I Psoriasis-studie I og II var det primære endepunkt den andel af patienterne, som opnåede et PASI 75-respons i forhold til baseline ved uge 16 (se tabel 17 og 18).
English: Health-related quality of life and physical function were assessed using the disability index of the Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, which was a prespecified primary endpoint at week 52 in RA study III.
Danish: Helbredsrelateret livskvalitet og fysisk funktion blev evalueret ud fra et fysisk funktionsevneindeks fra Health Assessment Questionnaire (HAQ) i de fire originale adækvate og velkontrollerede studier, som var et allerede specificeret primært endepunkt ved uge 52 i RA-studie III.
English: p-value p-value p-value
Danish: p-værdi p-værdi b p-værdi
English: Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Pediatric ACR 50 response, and Pediatric ACR 70 response.
Danish: Selvom det ikke var statistisk signifikant, viste størstedelen af patienterne klinisk bedring i sekundære endepunkter, såsom antallet af steder med entesopatirelateret artrit, antallet af ømme led (TJC), antallet af hævede led (SJC), pædiatrisk ACR 50-respons og pædiatrisk ACR 70-respons.
English: • You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Cyltezo treatment.
Danish: • Du bør overveje brugen af passende prævention for at forhindre graviditet og fortsætte brugen mindst 5 måneder efter den sidste behandling med Cyltezo.
English: Cyltezo treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Cyltezo is indicated.
Danish: Behandling med Cyltezo bør initieres og superviseres af speciallæger med erfaring i diagnosticering og behandling af de sygdomme, som Cyltezo er indiceret til.
English: Before initiation of therapy with Cyltezo, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Danish: Før behandling med Cyltezo påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkulose.
English: Treatment with Cyltezo can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Danish: Behandling med Cyltezo kan initieres i kombination med kortikosteroider og/eller andre ikke biologiske immunmodulerende lægemidler.
English: Ps Study II (CHAMPION) - Efficacy Results at 16 Weeks MTX N = 110 n (%)
Danish: Ps-studie II (CHAMPION) Virkningsresultater ved uge 16 MTX N = 110 n (%)
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 19).
Danish: Vurdering af neglepsoriasis inkluderede Modified Nail Psoriasis Severity Index (mNAPSI), Physician's Global Assessment of Fingernail Psoriasis (PGA-F) og Nail Psoriasis Severity Index (NAPSI) (se tabel 19).
English: Carriers of HBV who require treatment with Cyltezo should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Danish: Bærere af HBV, som kræver behandling med Cyltezo, bør overvåges tæt for tegn og symptomer på aktiv HBV-infektion gennem behandlingen og i adskillige måneder efter afslutningen af behandlingen.
English: Do not use this medicine after the expiry date which is stated on the label/blister/carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den
English: Improvement in health-related quality of life and physical function was maintained during the open-label
Danish: Helbredsrelateret livskvalitet og fysisk funktion blev opretholdt i den åbne forlængelsesfase op til
English: Among the 250 subjects who completed the open-label extension study, improvements in physical function were maintained through 10 years of treatment.
Danish: Ud af 250 patienter som afsluttede det åbne forlængelsesstudie blev forbedring af fysisk funktion opretholdt gennem 10 års
English: • There have been very rare cases of certain kinds of cancer in children and adults taking adalimumab or other TNFα blockers.
Danish: • Der er set meget sjældne tilfælde af visse kræfttyper hos voksne, som tager adalimumab eller andre TNFα-hæmmere.
English: The impact of long-term treatment with Cyltezo on the development of autoimmune diseases is unknown.
Danish: Det vides ikke, hvilken virkning langtidsbehandling med Cyltezo har på udviklingen af autoimmune sygdomme.
English: Patients may first be given other disease-modifying medicines, such as methotrexate.
Danish: Patienterne skal først behandles med anden sygdomsdæmpende medicin såsom methotrexat.
English: These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, other opportunistic infections (unusual infections associated with a weakened immune system) and sepsis (blood poisoning).
Danish: Disse infektioner kan være alvorlige og inkluderer tuberkulose, infektioner forårsaget af virus, svampe, parasitter eller bakterier, andre opportunistiske infektioner (usædvanlige infektioner forbundet med et svækket immunsystem) og sepsis (blodforgiftning).
English: The distribution of patients by age and minimum, median and maximum dose received during the OL LI phase is presented in Table 11.
Danish: Fordelingen af patienter i henhold til alder samt modtaget minimums-, median-og maksimumsdosis i den åbne indkøringsfase er vist i tabel 11.
English: In patients with Crohn's disease, a reduction of the number of cells expressing inflammatory markers in the colon including a significant reduction of expression of TNFα was seen.
Danish: Hos patienter med Crohns sygdom sås en reduktion i antallet af celler med ekspression af inflammatoriske markører i colon, inklusive en betydelig reduktion i antallet af celler med TNFαekspression.
English: You should record the date when the pen is first removed from refrigerator and the date after which it should
Danish: Du skal registrere den dato, hvor pennen først tages ud af køleskabet, og den dato efter hvilken, den
English: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with
Danish: Adalimumab modulerer også de biologiske responser, som induceres eller reguleres af TNF, herunder ændringer i niveauerne af de adhæsionsmolekyler, som er ansvarlige for leukocytmigrationen (ELAM-1, VCAM-1 og ICAM-1 med en IC50 på 0,1-0,2 nM).
English: CD Study II: Infliximab Experienced Patients
Danish: CD-Studie I: Infliximab naive patienter CD-Studie II: Infliximab erfarne patienter
English: Treatment with Cyltezo may result in the formation of autoimmune antibodies.
Danish: Behandling med Cyltezo kan medføre dannelse af autoimmune antistoffer.
English: Patients receiving MTX who achieved a ≥ PASI 50 response at week 8 and/or 12 did not receive further dose increases.
Danish: Patienter, som fik methotrexat, som opnåede et ≥ PASI 50-respons ved uge 8 og/eller 12, fik ikke yderligere dosisøgning.
English: • Hold syringe at about a 45 degree angle to injection site, then insert needle into skin with a quick,
Danish: • Hold injektionssprøjten med en vinkel på omkring 45 grader i forhold til injektionsstedet, og indsæt kanylen i huden med en hurtig, jævn bevægelse.
English: • Remove cap by pulling it straight off pen.
Danish: • Fjern hætten ved at trække den lige af pennen.
English: The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percent of patients who achieved an ACR 20 response at week 24 or 26.
Danish: Det primære endepunkt i RA-studie I, II og III og det sekundære endepunkt i RA-studie IV var procentdelen af patienter, som fik ACR 20-respons i uge 24 eller 26.
English: • If you are about to have a surgery or dental procedures, tell your doctor that you are taking Cyltezo.
Danish: • Hvis du skal have en operation eller tandbehandling, skal du fortælle lægen, at du tager Cyltezo.
English: Adalimumab was numerically favoured for the majority of subscores with statistically significant mean differences for general vision, ocular pain, near vision, mental health, and total score in Study UV I, and for general vision and mental health in Study UV II.
Danish: Adalimumab havde numerisk en fordel ved de fleste af underscorerne med statistisk signifikante gennemsnitlige forskelle i generelt syn, okulær smerte, nærsyn, mental sundhed og totalscore i studie UV I og for generelt syn og mental sundhed i Studie UV II.
English: The active ingredient in Cyltezo, adalimumab, is a monoclonal antibody.
Danish: Det aktive stof i Cyltezo, adalimumab, er et monoklonalt antistof.
English: These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and/or gold salts.
Danish: Disse terapier omfatter methotrexat, leflunomid, hydroxychloroquin, sulfasalazin og/eller guldsalt.
English: Patients should be tested for HBV infection before initiating treatment with Cyltezo.
Danish: Patienter bør testes for HBV-infektion inden behandling med Cyltezo.
English: The MAH shall ensure that in each Member State where Cyltezo is marketed, all healthcare professionals who are expected to prescribe Cyltezo have are provided with the following educational package:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger og sundhedspersonale, som forventes at ordinere Cyltezo i alle medlemslande, hvor Cyltezo markedsføres, udstyres med den følgende uddannelsespakke:
English: Cerebrovascular accident tremor, neuropathy
Danish: , tremor, neuropati
English: Taking these results into consideration, Cyltezo is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Danish: I betragtning af disse resultater anbefales Cyltezo til anvendelse i kombination med MTX og til anvendelse som monoterapi til patienter, som ikke egner sig til behandling med MTX (se pkt.
English: b at Weeks 24 and 36 After Treatment Reassignment from Weekly adalimumab at Week 12
Danish: b ved uge 24 og 36 efter tildeling af behandling ved uge 12 (fra ugentlig adalimumab)
English: One hundred patients (n = 100) from the Paediatric CD Study continued in an open-label long-term extension study.
Danish: Ethundrede patienter (N = 100) fra det pædiatriske Crohn-studie fortsatte i langtidsbehandling i et åbent forlængelsesstudie.