FrancophonIA/ELRC3.0 huggingface dataset:
English: Radiographs of hands and feet were obtained at baseline, 24 weeks, and 52 weeks and scored independently by at least two well-trained readers who were blinded to treatment group and visit number.
Danish: Røntgen af hænder og fødder blev foretaget ved baseline, uge 24 og uge 52 og blev vurderet uafhængigt af hinanden af mindst to trænede aflæsere, som var blindet for behandlingsgruppe og besøgsantal.
English: Most patients who developed gastrointestinal perforations were taking concomitant nonsteroidal anti-inflammatory medications (NSAIDs), corticosteroids, or methotrexate.
Danish: De fleste af de patienter, som oplevede gastrointestinal perforering, tog samtidigt non-steroide anti-inflammatoriske lægemidler (NSAID'er), kortikosteroid eller methotrexat.
English: Method of Administration Subcutaneous use.
Danish: Administration Subkutan anvendelse.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyrestudier viser ingen direkte eller indirekte skadelig virkning med hensyn til reproduktionstoksicitet (se pkt.
English: The efficacy and safety of Kevzara were assessed in three randomised, double-blind, controlled multicentre studies (MOBILITY and TARGET were placebo-controlled studies and MONARCH was an active comparator-controlled study) in patients older than 18 years with moderately to severely active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria.
Danish: Kevzaras virkning og sikkerhed blev undersøgt i tre randomiserede, dobbeltblinde, kontrollerede multicenterstudier (MOBILITY og TARGET var placebokontrollerede studier og MONARCH var et aktivt komparatorkontrolleret studie) hos patienter over 18 år med moderat til svær aktiv reumatoid artritis, som blev diagnosticeret ifølge kriterierne fra American College of Rheumatology (ACR).
English: Cases of opportunistic infection have been reported (see section 4.4).
Danish: Der er rapporteret tilfælde af opportunistiske infektioner (se pkt.
English: • you have recently had any vaccination or are going to have a vaccination.
Danish: • hvis du for nyligt er blevet vaccineret eller skal vaccineres.
English: Increased frequency and magnitude of these elevations were observed when potentially hepatotoxic medicinal products (e.g., MTX) were used in combination with Kevzara.
Danish: Disse forhøjelser forekom hyppigere og i en øget størrelsesorden, når potentielt levertoksiske lægemidler (f.eks. MTX) blev anvendt sammen med Kevzara.
English: Patients should be managed according to clinical guidelines for the management of hyperlipidaemia.
Danish: Patienten skal behandles ifølge de kliniske retningslinjer for behandling af hyperlipidæmi.
English: No correlation was observed between ADA development and either loss of efficacy or adverse events.
Danish: Der blev ikke observeret nogen korrelation mellem ADA-dannelse og effekt eller bivirkninger.
English: The excretion of sarilumab in Cynomolgus monkey's milk has not been studied.
Danish: Udskillelsen af sarilumab i cynomolgusabers mælk er ikke undersøgt.
English: Of these, 2170 patients received Kevzara for at least 24 weeks, 1546 for at least 48 weeks, 1020 for at least 96 weeks, and 624 for at least 144 weeks.
Danish: Af disse fik 2.170 patienter Kevzara i mindst 24 uger, 1.546 fik Kevzara i mindst 48 uger, 1.020 fik Kevzara i mindst 96 uger, og 624 fik Kevzara i mindst 144 uger.
English: The modulation of IL-6 effect on CYP enzymes by sarilumab may be clinically relevant for CYP substrates with a narrow therapeutic index, where the dose is individually adjusted.
Danish: Sarilumabs modulation af IL-6-effekten på CYP-enzymer kan være klinisk relevant for CYPsubstrater med et snævert terapeutisk indeks, hvor dosis justeres individuelt.
English: Treatment with sarilumab resulted in decreases in fibrinogen and serum amyloid A, and increases in haemoglobin and serum albumin.
Danish: Behandling med sarilumab medførte fald i fibrinogen og serumamyloid A og stigning i hæmoglobin og serumalbumin.
English: There are limited data available on overdose with Kevzara.
Danish: Der foreligger begrænsede data om overdosering med Kevzara.
English: Do not touch the injection site again before the injection.
Danish: Rør ikke injektionsstedet igen, før indsprøjtningen gives.
English: Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see section 5.1).
Danish: Kevzara kan gives som monoterapi i tilfælde af intolerans over for MTX eller når behandling med MTX er uhensigtsmæssig (se pkt.
English: If confirmed by repeat testing, treatment with Kevzara should be discontinued.
Danish: Hvis bekræftet ved gentagen testning skal behandling med Kevzara seponeres.
English: After removing the pre-filled syringe/pre-filled pen from the refrigerator, it should be allowed to reach room temperature (<25°C) before injecting Kevzara.
Danish: Efter at have taget den fyldte injektionssprøjte/fyldte pen ud af køleskabet, skal den opnå stuetemperatur (<25°C), inden Kevzara injiceres.
English: Two patients on Kevzara (0.2%) discontinued treatment due to injection site reactions.
Danish: Hos to patienter, som fik Kevzara (0,2%) blev behandlingen seponeret på grund af reaktioner på injektionsstedet.
English: Insert the needle into the fold of skin at roughly a 45º angle.
Danish: Stik kanylen ind i den sammenklemte hudfold i en vinkel på 45º.
English: The most frequently observed serious infections included pneumonia and cellulitis.
Danish: De hyppigst observerede alvorlige infektioner omfattede pneumoni og cellulitis.
English: Once removed from the refrigerator, Kevzara should be administered within 14 days and should not be stored above 25 ºC.
Danish: Når Kevzara er taget ud af køleskabet, bør det administreres inden for 14 dage og må ikke opbevares ved temperaturer over 25 ºC.
English: Treatment with Kevzara should be withheld if a patient develops a serious infection or an opportunistic infection.
Danish: Behandling med Kevzara skal afbrydes, hvis en patient udvikler en alvorlig infektion eller en opportunistisk infektion.
English: Sarilumab had no effect on maintenance of pregnancy or on the neonates evaluated up to 1 month after birth in body weight measurements, in parameters of functional or morphological development including skeletal evaluations, in immunophenotyping of peripheral blood lymphocytes, and in microscopic evaluations.
Danish: Sarilumab påvirkede ikke opretholdelse af graviditet eller de nyfødte, som blev undersøgt op til 1 måned efter fødslen ved hjælp af kontrol af legemsvægt, parametre for funktionel og morfologisk udvikling, herunder undersøgelse af skelet, immunfænotypebestemmelse af lymfocytter fra perifert blod og mikroskopiske undersøgelser.
English: Patients presenting with new onset abdominal symptoms such as persistent pain with fever should be evaluated promptly (see section 4.8).
Danish: Patienter med nye abdominale symptomer, som f.eks. vedvarende smerter med feber, skal omgående undersøges (se pkt.
English: The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Danish: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100);
English: Prior to initiating Kevzara, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.
Danish: Det anbefales, at alle patienter, inden påbegyndelse af Kevzara-behandling, bringes ajour med alle immuniseringer i overensstemmelse med gældende retningslinjer for immunisering.
English: Results at 24 weeks in TARGET were similar to the results at 52 weeks in MOBILITY (see Table 3).
Danish: Resultater ved uge 24 i TARGET svarede til resultaterne ved uge 52 i MOBILITY (se Tabel 3).
English: A patient who develops an infection during treatment with Kevzara should also undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored.
Danish: Patienter, som udvikler en infektion, mens de er i behandling med Kevzara, bør også straks gennemgå en komplet diagnostisk undersøgelse, som er relevant for immunkompromitterede patienter, passende antimikrobiel behandling bør indledes og patienten bør monitoreres tæt.
English: Liver enzyme abnormalities are summarised in Table 2.
Danish: Abnorme leverenzymværdier er vist i Tabel 2.
English: MOBILITY MTX Inadequate Responders
Danish: MOBILITY Patienter med utilstrækkelig respons på MTX
English: Industriepark Hochst 65926 Frankfurt am Main Germany
Danish: Industriepark Hochst 65926 Frankfurt am Main Tyskland
English: After the last steady state dose of 150 mg and 200 mg sarilumab, the median times to non-detectable concentration are 30 and 49 days, respectively.
Danish: Efter den sidste steady-state-dosis på 150 mg og 200 mg sarilumab er mediantid til ikke-detekterbare koncentrationer henholdsvis 30 og 49 dage.
English: • Write down the date of removal from the refrigerator in the space provided on the outer carton.
Danish: • Noter datoen for udtagning fra køleskab på kartonen.
English: • then inject your next dose at your regular time.
Danish: • injicer den efterfølgende dosis på det sædvanlige tidspunkt.
English: This device is a single-dose pre-filled pen (called “pen” in these instructions).
Danish: Denne anordning er en enkeltdosis fyldt pen (kaldes “pen” i denne vejledning).
English: In MOBILITY, structural joint damage was assessed radiographically and expressed as change in van der Heijde-modified Total Sharp Score (mTSS) and its components, the erosion score, and joint space narrowing score at Week 52.
Danish: I MOBILITY blev strukturel ledskade undersøgt radiografisk og udtrykt som ændring i van der Heijde-modified Total Sharp Score (mTSS) og dets komponenter, erosionsscore og score for ledspalteforsnævring ved uge 52.
English: The most frequent adverse reactions observed with Kevzara in clinical studies were neutropenia, increased ALT, injection site erythema, upper respiratory infections, and urinary tract infections.
Danish: De hyppigst observerede bivirkninger med Kevzara i kliniske studier var neutropeni, forhøjet ALAT, erytem ved injektionsstedet, øvre luftvejsinfektioner og urinvejsinfektioner.
English: The excretion of sarilumab in milk has not been studied in animals (see section 5.3).
Danish: Udskillelse af sarilumab i mælk er ikke undersøgt hos dyr (se pkt.
English: Kevzara should not be administered in patients with an active infection, including localised infections.
Danish: Kevzara må ikke administreres til patienter med aktive infektioner, inklusive lokale infektioner.
English: • a group of medicines called “Janus kinase (JAK) inhibitors” (used for diseases like rheumatoid arthritis and cancer)
Danish: • en gruppe lægemidler kaldet ”Janus kinase (JAK)-hæmmere” (anvendes mod sygdomme som kronisk leddegigt og kræft)
English: Sarilumab exposure was not affected when coadministered with MTX based on the population pharmacokinetic analyses and across study comparisons.
Danish: Eksponeringen af sarilumab blev i kliniske studier ikke påvirket ved samtidig administration af MTX baseret på populationsfarmakokinetiske analyser og sammenligninger på tværs af studierne.
English: Do not inject through your clothes.
Danish: Foretage indsprøjtningen gennem tøjet.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Kevzara (sarilumab) in one or more subsets of the paediatric population in chronic idiopathic arthritis (including rheumatoid arthritis, spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis) (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Kevzara (sarilumab) i en eller flere undergrupper af den pædiatriske population ved kronisk idiopatisk artritis (herunder reumatoid artritis, spondylartrit, psoriasisartrit og juvenil idiopatisk artrit) (se pkt.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: IL-6 is involved in diverse physiological processes such as migration and activation of T-cells, B-cells, monocytes, and osteoclasts leading to systemic inflammation, synovial inflammation, and bone erosion in patients with RA.
Danish: IL-6 er involveret i forskellige fysiologiske processer som f.eks. migration og aktivering af T-celler, B-celler, monocytter og osteoklaster, hvilket medfører systemisk inflammation, synovial inflammation og knogleerosion hos patienter med RA.
English: Following single-dose sarilumab administration, in patients with RA, ANC decreased to the nadir between 3 to 4 days and thereafter recovered towards baseline (see section 4.4).
Danish: Efter en enkeltdosis administration af sarilumab hos patienter med RA faldt ANC til minimumsniveauet i ca. 3-4 dage, og derefter vendte det tilbage til baseline (se pkt.
English: Results at 52 weeks in MOBILITY were similar to the results at 24 weeks for TARGET.
Danish: Resultaterne ved uge 52 i MOBILITY svarede til resultaterne ved uge 24 for TARGET.
English: *cDMARDs in TARGET included MTX, sulfasalazine, leflunomide and hydroxychloroquine p-value <0.01 for difference from placebo ††p-value <0.001 for difference from placebo †††p-value <0.0001 for difference from placebo ‡ Primary endpoint § NA=Not Applicable as TARGET was a 24-week study ¶ Major clinical response = ACR70 for at least 24 consecutive weeks during the 52-week period
Danish: * cDMARDs i TARGET inkluderede MTX, sulfasalazin, leflunomid og hydroxychloroquin p-værdi <0,01 for forskel fra placebo ††p-værdi <0,001 for forskel fra placebo †††p-værdi <0,0001 for forskel fra placebo ‡ Primært endepunkt § NA=Ikke relevant eftersom TARGET var et 24-ugers studie ¶Større klinisk response = ACR70 i mindst 24 sammenhængende uger gennem en periode på 52 uger
English: Kevzara 200 mg was superior to adalimumab 40 mg in reducing disease activity and improving physical function, with more patients achieving clinical remission over 24 weeks (see Table 6).
Danish: Kevzara 200 mg var overlegen i forhold til adalimumab 40 mg med hensyn til at reducere sygdomsaktivitet og forbedre fysisk funktion, og flere patienter opnåede klinisk remission over 24 uger (se Tabel 6).
English: Press down and hold the pen firmly against your skin.
Danish: Tryk ned, og hold pennen fast ned mod huden.
English: Upper respiratory tract infection Urinary tract infection Nasopharyngitis Oral herpes
Danish: Øvre luftvejsinfektion Urinvejsinfektion Nasofaryngitis Oral herpes
English: Read all of the instructions carefully before using a pen.
Danish: Læse hele vejledningen grundigt, før du bruger pennen.
English: Keep the remaining pen in the carton in the refrigerator.
Danish: Lad de resterende penne blive i kartonen i køleskabet.
English: • if you are allergic to sarilumab or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for sarilumab eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: These elevations were not associated with clinically relevant increases in direct bilirubin, nor were they associated with clinical evidence of hepatitis or hepatic insufficiency (see section 4.4).
Danish: Disse stigninger var ikke associeret med klinisk relevante stigninger i direkte bilirubin og var heller ikke associeret med kliniske tegn på hepatitis eller nedsat leverfunktion (se pkt.
English: Upon initiation or discontinuation of Kevzara in patients being treated with CYP substrate medicinal products, therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., theophylline) should be performed and the individual dose of the medicinal product should be adjusted as needed.
Danish: Når behandling med Kevzara indledes eller ophører, skal patienter, der behandles med CYP-substrater, monitoreres terapeutisk for effekt (f.eks. warfarin) eller lægemiddelkoncentration (f.eks. theophyllin) og den individuelle dosis af lægemidlet bør justeres ved behov.
English: • Clean skin with an alcohol wipe.
Danish: • Aftør huden med en spritserviet.
English: Clinically appropriate dose modification of concomitant DMARDs should be considered.
Danish: En klinisk relevant dosisjustering af eventuel tillægsbehandling med DMARDs bør overvejes.
English: The interval between live vaccinations and initiation of Kevzara therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents (see section 4.5).
Danish: Tidsrummet mellem vaccination med levende vacciner og påbegyndelse af Kevzara-behandling skal være i henhold til de gældende retningslinjer for vaccination med immunsuppressive lægemidler (se pkt.
English: What you need to know before you use Kevzara Do not use Kevzara:
Danish: Det skal du vide, før du begynder at bruge Kevzara Brug ikke Kevzara:
English: Do not
Danish: Du må ikke
English: Caution should be exercised in patients who start Kevzara treatment while on therapy with CYP3A4 substrates (e.g., oral contraceptives or statins), as Kevzara may reverse the inhibitory effect of IL-6 and restore CYP3A4 activity, leading to decreased exposure and activity of CYP3A4 substrate.
Danish: Der bør udvises forsigtighed hos patienter, som indleder behandling med Kevzara, mens de er i behandling med CYP3A4-substrater (f.eks. orale kontraceptiva eller statiner), da Kevzara kan reversere IL-6's hæmmende effekt og gendanne CYP3A4-aktivitet, hvilket fører til reduceret CYP3A4-substrat eksponering og aktivitet (se pkt.
English: The safety and efficacy of Kevzara have not been studied in patients with hepatic impairment, including patients with positive hepatitis B virus (HBV) or hepatitis C virus (HCV) serology (see section 4.4).
Danish: Kevzaras sikkerhed og virkning er ikke undersøgt hos patienter med nedsat leverfunktion, inklusive patienter, som er testet positive for hepatitis B-virus (HBV) eller hepatitis C-virus (HCV) i serologitests (se pkt.
English: The pharmacokinetics of sarilumab were characterised in 2186 patients with RA treated with sarilumab which included 751 patients treated with 150 mg and 891 patients treated with 200 mg subcutaneous doses every two weeks for up to 52 weeks.
Danish: Sarilumabs farmakokintik blev beskrevet hos 2.186 patienter med RA, der blev behandlet med sarilumab og hvoraf 751 patienter blev behandlet med 150 mg og 891 patienter blev behandlet med 200 mg subkutant hver 2. uge i op til 52 uger.
English: No data are available on the effect of sarilumab on human fertility.
Danish: Der foreligger ingen data for sarilumabs påvirkning af fertiliteten hos mennesker.
English: MONARCH was a 24 -week randomised double-blind, double-dummy study that compared Kevzara 200 mg monotherapy with adalimumab 40 mg monotherapy administered subcutaneously every two weeks in 369 patients with moderately to severely active RA who were inappropriate for treatment with MTX including those who were intolerant of or inadequate responders to MTX.
Danish: MONARCH var et randomiseret, dobbeltblindt, double-dummy studie af 24 ugers varighed, som sammenlignede Kevzara 200 mg monoterapi med adalimumab 40 mg monoterapi administreret subkutant hver 2. uge hos 369 patienter med moderat til svær, aktiv RA, som ikke egnede sig til behandling med MTX, herunder patienter, som ikke tolererede behandling med MTX eller havde utilstrækkelig respons på behandling med MTX.
English: • You and your doctor should decide if you should use Kevzara if you are breast-feeding.
Danish: • Du bør sammen med din læge beslutte, om du kan bruge Kevzara, mens du ammer.
English: Patients with latent or active tuberculosis should be treated with standard antimycobacterial therapy before initiating Kevzara.
Danish: Patienter med latent eller aktiv tuberkulose bør behandles med standard antimykobakterielle midler, inden behandling med Kevzara initieres.
English: If you stop using Kevzara
Danish: Hvis du holder op med at bruge Kevzara
English: Because IgG1 are excreted in human milk, a decision should be made whether to discontinue breastfeeding or to discontinue sarilumab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Eftersom IgG1 udskilles i modermælk, bør der tages en beslutning om, hvorvidt amning eller behandling med Kevzara bør ophøre ud fra en vurdering af fordelene ved amning for barnet og fordelene ved behandlingen for kvinden (se pkt.
English: Prepare the injection site.
Danish: Klargør injektionsstedet.
English: Kevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs).
Danish: Kevzara er i kombination med methotrexat (MTX) indiceret til behandling af moderat til svær, aktiv reumatoid artritis (RA) hos voksne patienter, som enten har haft utilstrækkelig respons på, eller som ikke tolererer en eller flere sygdomsmodificerende antireumatiske lægemidler (DMARDs).
English: In vitro and in vivo studies with sarilumab using human tumour cell lines showed inhibition of STAT-3 activation and inhibition of tumour growth in human tumour xenograft animal models.
Danish: In vitro og in vivo-studier med sarilumab og humane tumorcellelinjer viste hæmning af STAT-3-aktivering og hæmning af tumorvækst i modeller med humane tumor xenografter hos dyr.
English: At steady state, exposure over the dosing interval measured by AUC increased approximately 2fold with a 1.33-fold increase in dose from 150 to 200 mg every two weeks.
Danish: Ved steady-state blev eksponering i løbet af dosisintervallet, målt som AUC, ca. fordoblet med en 1,33 gange stigning i dosis fra 150 til 200 hver 2. uge.
English: Kevzara has no or negligible influence on the ability to drive or operate machinery.
Danish: Kevzara påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: • You can inject into your thigh or belly (abdomen) except for the 5 cm around your belly button (navel).
Danish: • Du kan foretage indsprøjtningen i låret eller maven undtagen 5 cm rundt om navlen.
English: Low Platelet Count Lab Value (cells x 103/µL)
Danish: Lavt trombocyttal Laboratorieværdi (celler x 103/µl)
English: There were no reports of gastrointestinal perforation in the Kevzara monotherapy population.
Danish: Der er ingen rapporter om gastrointestinal perforering i populationen med Kevzara monoterapi.
English: (see section 5.2).Interaction of sarilumab with substrates of other CYPs (CYP2C9, CYP 2C19, CYP2D6) has not been studied.
Danish: Sarilumabs interaktion med andre CYPsubstrater (CYP2C9, CYP2C19, CYP2D6) er ikke blevet undersøgt.
English: Sarilumab is a human monoclonal antibody (IgG1 subtype) that specifically binds to both soluble and membrane-bound IL-6 receptors (IL-6Rα), and inhibits IL-6-mediated signalling which involves ubiquitous signal-transducing glycoprotein 130 (gp130) and the Signal Transducer and Activator of Transcription-3 (STAT-3).
Danish: Sarilumab er et humant monoklonalt antistof (IgG1-subtype), der binder sig specifikt til både opløselige og membranbundne IL-6 receptorer (IL-6Rα) og hæmmer IL-6-medieret signalering, som omfatter glycoprotein 130 (gp130) og Signal Transducer and Activator of Transcription-3 (STAT-3).
English: ALT > 5 x ULN
Danish: ALAT > 5 x ULN
English: Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving immunosuppressive agents including Kevzara for RA.
Danish: Der er rapporteret alvorlige og i nogle tilfælde dødelige infektioner, der skyldes bakterielle, mykobakterielle, invasive svampeinfektioner, virale eller andre opportunistiske patogener hos patienter, der bliver behandlet for RA med immunsuppressiva, inklusive Kevzara.