FrancophonIA/ELRC3.0 huggingface dataset:
English: Reports of gastrointestinal perforation were primarily reported as complications of diverticulitis including lower GI perforation and abscess.
Danish: Rapporter om gastrointestinal perforering blev hovedsageligt rapporteret som komplikationer til diverticulitis inklusiv nedre gastrointestinal perforering og absces.
English: Patients with severe renal impairment were not studied.
Danish: Patienter med svært nedsat nyrefunktion er ikke undersøgt.
English: Injection sites (abdomen, thigh and upper arm) should be rotated with each injection.
Danish: Der skiftes mellem injektionsstederne (abdomen, lår og overarm) ved hver injektion.
English: Treatment should be initiated and supervised by healthcare professionals experienced in the diagnosis and treatment of rheumatoid arthritis.
Danish: Behandling bør initieres og overvåges af speciallæger med erfaring i diagnostik og behandling af reumatoid artritis.
English: Do not rub your skin after the injection.
Danish: Du må ikke gnide på huden efter injektionen.
English: Events of gastrointestinal perforation have been reported in clinical studies, primarily as complications of diverticulitis.
Danish: I kliniske studier er der rapporteret tilfælde af gastrointestinal perforering, hovedsageligt som komplikationer til diverticulitis.
English: • A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient is using Kevzara.
Danish: o En advarsel til læger og sundhedspersonale, der på et givet tidspunkt har patienten i behandling, herunder i akutsituationer, om at patienten er i behandling med Kevzara.
English: Following single-dose subcutaneous (SC) administration of sarilumab 200 mg and 150 mg in patients with RA rapid reduction of CRP levels was observed.
Danish: Efter en enkelt dosering subkutan (s.c.) administration af sarilumab 200 mg eller 150 mg hos patienter med RA blev der observeret en hurtig reduktion af CRP-niveauet.
English: Anti Drug Antibody (ADA) formation may affect pharmacokinetics of Kevzara.
Danish: Anti-lægemiddel-antistof (ADA)-dannelse kan påvirke Kevzaras farmakokinetik.
English: Injection site rash, rash, and urticaria were the most frequent hypersensitivity reactions.
Danish: Udslæt ved injektionsstedet, udslæt og urticaria var de hyppigste overfølsomhedsreaktioner.
English: The recommended dose is one 200 mg injection every two weeks.
Danish: Den anbefalede dosis er 200 mg som injektion hver 2. uge.
English: Kevzara can then be resumed at 150 mg every 2 weeks and increased to 200 mg every 2 weeks as clinically appropriate.
Danish: Kevzara kan derefter genoptages med 150 mg hver 2. uge og øges til 200 mg hver 2. uge i henhold til en klinisk vurdering.
English: • Based on the pharmacodynamics of the changes in ANC, use results obtained at the end of the dosing interval when considering dose modification (see section 5.1).
Danish: • På baggrund af de farmakodynamiske ændringer i ANC, bør det være ANC-værdierne indsamlet ved afslutning af doseringsintervallet, der anvendes, hvis dosisjusteringer overvejes (se pkt.
English: Do not heat the pen; let it warm up on its own.
Danish: Du må ikke opvarme pennen; lad den selv nå den rette temperatur.
English: No dosage adjustment is required in patients with mild to moderate renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion.
English: • Educate patients on signs or symptoms that could represent serious infections or gastrointestinal perforations to seek for medical attention immediately.
Danish: o Oplyse patienten om, at der ved tegn og symptomer på alvorlige infektioner eller gastrointestinal perforering øjeblikkeligt skal søges lægehjælp.
English: • That Kevzara treatment may increase the risks of serious infections, neutropenia and intestinal perforation.
Danish: o Kevzara kan øge risikoen for alvorlige infektioner, neutropeni og gastrointestinal perforering.
English: Pull the pen away from your skin.
Danish: Fjern pennen fra huden.
English: There is no specific treatment for Kevzara overdose.
Danish: Der findes ingen specifik behandling af overdosering med Kevzara.
English: Laboratory parameters Neutrophil count Treatment with Kevzara was associated with a higher incidence of decrease in ANC.
Danish: Laboratorieparametre Neutrofiltal Behandling med Kevzara er blevet associeret med en øget forekomst af et fald i ANC.
English: Contents of the pack and other information What Kevzara contains
Danish: Pakningsstørrelser og yderligere oplysninger Kevzara indeholder:
English: Keep holding the pen firmly against your skin.
Danish: Bliv ved med at holde pennen fast ned mod huden.
English: Patients treated with Kevzara should be given the patient alert card.
Danish: Patienter, som behandles med Kevzara, skal have udleveret et patientinformationskort.
English: In the Kevzara +DMARDs long-term safety population, the rates of infections and serious infection were 57.3 and 3.4 events per 100-patient years, respectively.
Danish: I langtidssikkerhedspopulationen med Kevzara + DMARDs var hyppigheden af infektioner og alvorlige infektioner henholdsvis 57,3 og 3,4 hændelser pr. 100 patientår.
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: At Week 4 the mean LDL increased by 14 mg/dL; mean triglycerides increased by 23 mg/dL; and mean HDL increased by 3 mg/dL. After Week 4 no additional increases were observed.
Danish: Ved uge 4 var gennemsnitlig LDL steget med 4 mg/dl; gennemsnitlige triglycerider var steget med 23 mg/dl; og gennemsnitlig HDL steg med 3 mg/dl.
English: Physician global VAS‡ (0-100 mm) Patient global VAS‡ (0-100 mm) HAQ-DI
Danish: Ømme led Hævede led Smerter VAS† (0-100 mm) Lægens vurdering, global VAS‡ (0-100 mm) Patientens vurdering, global VAS‡ (0-100 mm) HAQ-DI (0-3) CRP
English: Both doses of Kevzara + MTX were superior to placebo + MTX in the change from baseline in mTSS at 24 and 52 weeks (see Table 5).
Danish: Begge doser Kevzara + MTX var overlegne i forhold til placebo + MTX med hensyn til ændring fra baseline i mTSS ved uge 24 og uge 52 (se Tabel 5).
English: For these reasons, comparison of the incidence of antibodies to Kevzara with the incidence of antibodies to other products may be misleading.
Danish: Derfor kan det være misvisende at sammenligne forekomsten af antistoffer mod Kevzara med forekomsten af antistoffer mod andre lægemidler.
English: Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait, France
Danish: Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait, Frankrig
English: • You will need an alcohol wipe, a cotton ball or gauze, and a puncture-resistant container.
Danish: • Du skal bruge en spritserviet, et stykke vat eller gaze og en kanylebeholder.
English: The primary endpoints were the proportion of patients who achieved an ACR20 response at Week 24 and the changes from baseline HAQ-DI score at Week 12.
Danish: De primære endepunkter var andelen af patienter, som nåede et ACR20-respons ved uge 24 og ændret score i forhold til baseline i HAQ-DI ved uge 12.
English: Mild to moderate renal impairment did not affect the pharmacokinetics of sarilumab.
Danish: Let til moderat nedsat nyrefunktion påvirkede ikke sarilumabs farmakokinetik.
English: IL-6 is a pleiotropic cytokine that stimulates diverse cellular responses such as proliferation, differentiation, survival, and apoptosis and can activate hepatocytes to release acute-phase proteins, including C-reactive protein (CRP) and serum amyloid A. Elevated levels of IL-6 are found in the synovial fluid of patients with rheumatoid arthritis and play an important role in both the pathologic inflammation and joint destruction which are hallmarks of RA.
Danish: IL-6 er et pleiotropisk cytokin, som stimulerer forskellige former for cellulær respons som f.eks. proliferation, differentiering, overlevelse og apoptose og som kan aktivere hepatocytter til at frigøre akut-faseproteiner, herunder C-reaktivt protein (CRP) og serumamyloid A. Der er fundet forhøjede koncentrationer af IL-6 i synovialvæsken hos patienter med reumatoid artritis, og disse spiller en vigtig rolle for både patologisk inflammation og nedbrydning af led, som er kendetegnende for RA.
English: Sarilumab is a human monoclonal antibody selective for the interleukin-6 (IL-6) receptor, produced in Chinese Hamster Ovary cells by recombinant DNA technology.
Danish: Sarilumab er et humant monoklonalt antistof rettet mod interleukin-6 (IL-6)-receptoren og fremstillet ved rekombinant DNA-teknologi i ovarieceller fra kinesiske hamstre.
English: Keep the remaining syringe in the carton in the refrigerator.
Danish: Lad de resterende sprøjter blive i kartonen i køleskabet.
English: After multiple dosing of 150 to 200 mg every two weeks, steady state was reached in 12 to 16 weeks with a 2- to 3-fold accumulation compared to single dose exposure.
Danish: Efter gentagne doser med 150 mg til 200 mg hver 2. uge blev steady-state nået på 12-16 uger med 2-3-foldig akkumulering i forhold til enkeltdosis eksponering.
English: The percentages of Kevzara + DMARDs-treated patients achieving ACR20, ACR50, and ACR70 responses in MOBILITY and TARGET are shown Table 3.
Danish: Procentdelen af de patienter, der fik Kevzara + DMARDs og som nåede ACR20-, ACR50- og ACR70-respons i MOBILITY og TARGET er vist i Tabel 3.
English: In functional human cell-based assays, sarilumab was able to block the IL-6 signalling pathway, measured as STAT-3 inhibition, only in the presence of IL-6.
Danish: I funktionelle humancellebaserede analyser kunne sarilumab kun blokere metaboliseringsvejen for IL6 signalering, målt som STAT-3-hæmning, under tilstedeværelse af IL-6.
English: Component (range)
Danish: Komponent (interval)
English: Select the injection site.
Danish: Vælg et injektionssted.
English: The weight of evidence for IL-6Rα inhibition mainly indicates anti-tumour effects mediated by multiple mechanisms predominantly involving STAT-3 inhibition.
Danish: Evidensmængden for IL-6Rα-hæmning udviser hovedsageligt antitumor effekt, som medieres gennem forskellige mekanismer og fortrinsvis indebærer STAT-3-hæmning.
English: Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections.
Danish: Hjælpestoffer: Histidin, arginin, polysorbat 20, saccharose, vand til injektionsvæsker.
English: Use Kevzara with caution in patients with previous history of intestinal ulceration or diverticulitis.
Danish: Kevzara skal anvendes med forsigtighed hos patienter med intestinal ulceration eller diverculitis i anamnesen.
English: Table 1: ADRs in controlled clinical studies
Danish: Tabel 1: Bivirkninger i kontrollerede kliniske studier
English: The primary endpoints were the proportion of patients who achieved an ACR20 response at Week 24, changes from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score at Week 16, and change from baseline in van der Heijde-modified Total Sharp Score (mTSS) at Week
Danish: De primære endepunkter var andelen af patienter, som nåede et ACR20-respons ved uge 24, ændret score i forhold til baseline i Health Assessment Questionnaire - Disability Index (HAQ-DI) ved uge 16 og ændret score i van der Heijde-modified Total Sharp Score (mTSS) ved uge 52.
English: Do not get rid of any air bubbles in the syringe.
Danish: Du skal ikke forsøge at fjerne luftboblerne i sprøjten.
English: Fertility studies conducted in male and female mice using a murine surrogate antibody against mouse IL-6Rα showed no impairment of fertility.
Danish: Fertilitetsstudier udført på han- og hunmus med et murint surrogat-antistof mod IL-6Rα hos mus viste ikke nedsat fertilitet.
English: ALT > 3 to 5 x ULN Treatment with Kevzara should be withheld until < 3 x ULN.
Danish: ALAT > 3 til 5 x ULN Behandling med Kevzara afbrydes indtil ALAT-værdien er < 3 x ULN.
English: The most common serious adverse reactions were infections (see section 4.4).
Danish: De mest almindelige alvorlige bivirkninger var infektioner (se pkt.
English: Treatment with Kevzara should be withheld in patients who develop a serious infection until the infection is controlled.
Danish: Behandling med Kevzara skal afbrydes hos patienter, som får en alvorlig infektion, indtil infektionen er under kontrol.
English: Injection site erythema Injection site pruritus
Danish: Erytem ved injektionsstedet Pruritus ved injektionsstedet
English: • high cholesterol, high triglycerides shown by blood tests
Danish: • Forhøjet kolesteroltal, forhøjet indhold af triglycerider, som ses i en blodprøve
English: At Week 52, 55.6% of patients receiving Kevzara 200 mg and 47.8% of patients receiving Kevzara 150 mg had no progression of structural damage (as defined by a change in the TSS of zero or less) compared with 38.7% of patients receiving placebo.
Danish: Ved uge 52 oplevede 55,6% af de patienter, der fik Kevzara 200 mg og 47,8% af de patienter, der fik Kevzara 150 mg ingen progression af strukturel skade (defineret som en ændring i TSS på nul eller derunder) sammenlignet med 38,7% af de patienter, der fik placebo.
English: • Your doctor, pharmacist, or nurse will show you how to inject Kevzara.
Danish: • Din læge, apotekspersonalet eller sundhedspersonalet vil vise dig, hvordan du skal foretage indsprøjtningen.
English: Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Solution for injection (injection) Clear, colourless to pale yellow sterile solution of approximately pH 6.0.
Danish: Injektionsvæske, opløsning (injektion) Klar, farveløs til lys gullig, steril opløsning med en pH på ca. 6,0.
English: • If you see any blood, press a cotton ball or gauze on the site.
Danish: • Hvis det bløder, kan du presse en stykke vat eller gaze mod stedet.
English: After use, place the pre-filled syringe/ pre-filled pen into a puncture-resistant container and discard as required by local regulations.
Danish: Efter brug lægges den fyldte injektionssprøjte/fyldte pen i en kanylebeholder og kasseres i henhold til lokale retningslinjer.
English: TARGET TNF Inhibitor Inadequate Responders
Danish: TARGET Patienter med utilstrækkelig respons på TNF-hæmmer
English: The contribution of these concomitant medications relative to Kevzara in the development of gastrointestinal perforations is not known (see section 4.4).
Danish: Disse lægemidlers medvirken, i forhold til Kevzaras medvirken, til udvikling af gastrointestinal perforering kendes ikke (se pkt.
English: The absolute bioavailability for sarilumab after SC injection was estimated to be 80% by population PK analysis.
Danish: I farmakokinetiske populationsanalyser blev sarilumabs absolutte biotilgængelighed efter s.c. injektion estimeret til 80%.
English: • The other ingredients are arginine, histidine, polysorbate 20, sucrose, and water for injections.
Danish: • Øvrige indholdsstoffer: arginin, histidin, polysorbat 20, saccharose og vand til injektionsvæsker.
English: In a usability study sarilumab exposure after 200 mg Q2W was slightly higher (Cmax + 24-34%, AUC(0-2w) +7-21%) after use of a pre-filled pen compared to the pre-filled syringe.
Danish: I et usability-studie var sarilumab-eksponering efter 200 mg hver 2. uge let forhøjet (Cmax + 24-34%, AUC(0-2 uger) +7-21%) efter brug af fyldt pen sammenlignet med fyldt injektionssprøjte.
English: Do not use the syringe if it has been out of the refrigerator for more than 14 days.
Danish: Du må ikke bruge sprøjten, hvis den har ligget uden for køleskabet i mere end 14 dage.
English: All presentations contain a 1.14 ml solution in a syringe (type 1 glass) equipped with a stainless steel staked needle and an elastomer plunger stopper.
Danish: Alle pakningsstørrelser indeholder 1,14 ml opløsning i en injektionssprøjte (type 1 glas) med en fastgjort kanyle af rustfrit stål og en elastomerprop.
English: The use of Kevzara is not expected to affect your ability to drive or use machines.
Danish: Det forventes ikke, at Kevzara påvirker din evne til at køre bil eller motorcykel eller betjene maskiner.
English: In the placebo-controlled population, one patient on Kevzara therapy experienced a gastrointestinal (GI) perforation (0.11 events per 100 patient-years).
Danish: I den placebokontrollerede population oplevede en patient i behandling med Kevzara en gastrointestinal (GI) perforering (0,11 hændelser pr. 100 patientår).
English: Elevated levels of interleukin-6 (IL-6) may down-regulate CYP activity such as in patients with RA and hence increase drug levels compared to subjects without RA.
Danish: Forhøjet niveau af interleukin-6 (IL6) kan nedregulere CYP-aktiviteten hos f.eks. patienter med RA og således øge lægemiddelkoncentrationen i forhold til hos forsøgspersoner uden RA.
English: • Carefully follow the “Instructions for Use” provided in the carton.
Danish: • Du skal nøje følge ”Brugervejledningen” i æsken.
English: Do not use the pen if it has been out of the refrigerator for more than 14 days.
Danish: Du må ikke bruge pennen, hvis den har ligget uden for køleskabet i mere end 14 dage.
English: Less progression of both erosion and joint space narrowing scores at 24 and 52 weeks was reported in the sarilumab treatment groups compared to the placebo group.
Danish: Der blev rapporteret mindre progression af både erosion og score for ledspalteforsnævring ved uge 24 og uge 52 i behandlingsgrupperne med sarilumab sammenlignet med placebogruppen.
English: Monoclonal antibodies are not eliminated via renal or hepatic pathways.
Danish: Monoklonale antistoffer elimineres ikke via nyrer og lever.
English: Table 2: Incidence of liver enzyme abnormalities in controlled clinical studies
Danish: Tabel 2: Forekomst af abnorme leverenzymværdier i kontrollerede kliniske studier
English: Figure 1: Percent of ACR20 Response by Visit for MOBILITY
Danish: Figur 1: Procent af ACR20-respons ved besøg vedr.
English: • Using the pen at room temperature may make the injection more comfortable.
Danish: • Hvis pennen har fået stuetemperatur, kan indsprøjtningen føles mere behagelig.
English: Do not expose the pen to direct sunlight.
Danish: Du må ikke udsætte pennen for direkte sollys.
English: • Low white blood cell counts shown by blood tests
Danish: • Lavt antal hvide blodlegemer, som ses i en blodprøve
English: Treatment with Kevzara 200 mg and 150 mg + MTX inhibited the progression of structural damage by 91% and 68%, respectively, compared to placebo + MTX at Week 52.
Danish: Behandling med Kevzara 200 mg and 150 mg + MTX hæmmede progression af strukturel skade med henholdsvis 91% og 68%, sammenlignet med placebo + MTX ved uge 52.
English: Do not use the pen if the date has passed.
Danish: Du må ikke bruge pennen, hvis udløbsdatoen er overskredet.
English: Blockade of IL-6 signalling by IL-6Rα antagonists such as sarilumab might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to altered medicinal products concentrations.
Danish: Blokering af IL-6-signalering med IL-6Rαantagonister som f.eks. sarilumab kan blokere IL-6's hæmmende effekt og genoprette CYP-aktivitet, hvilket medfører normaliserede lægemiddelkoncentrationer.
English: Mean change at Week 24 Modified Total Sharp Score (mTSS) Erosion score (0-280) Joint space narrowing score Mean change at Week 52 Modified Total Sharp Score (mTSS) ‡ Erosion score (0-280) Joint space narrowing score
Danish: Gennemsnitlig ændring ved uge 24 Modificeret Total Sharp Score (mTSS) Erosionsscore (0-280) Score for ledspalteforsnævring Gennemsnitlig ændring ved uge 52 Modificeret Total Sharp Score (mTSS) Erosionsscore (0-280) Score for ledspalteforsnævring
English: Let the pen warm up to room temperature for at least 60 minutes before using.
Danish: Lade pennen opnå stuetemperatur i mindst 60 minutter før brug.
English: Treatment with Kevzara was associated with a higher incidence of transaminase elevations.
Danish: Behandling med Kevzara er blevet associeret med en øget forekomst af transaminaseforhøjelse.
English: In the placebo-controlled population, the proportion of patients who discontinued treatment due to hypersensitivity reactions was higher among those treated with Kevzara (0.9% in 200 mg group, 0.5% in 150 mg group) than placebo (0.2%).
Danish: I den placebokontrollerede population var andelen af patienter, som ophørte med behandlingen på grund af overfølsomhedsreaktioner højere end hos de patienter, som blev behandlet med Kevzara (0,9% i gruppen med 200 mg, 0,5% i gruppen med 150 mg) end hos patienter, der blev behandlet med placebo (0,2%).
English: The activity of sarilumab in reducing inflammation is associated with laboratory changes such as decrease in ANC and elevation in lipids (see section 4.4).
Danish: Sarilumabs inflammationshæmmende aktivitet er associeret med ændringer i laboratorietests som nedsat ANC og forhøjede lipidniveauer (se pkt.
English: Proper training should be provided to patients and/or caregivers on the preparation and administration of Kevzara prior to use.
Danish: Patienten og/eller omsorgspersonen bør modtage den nødvendige oplæring i klargøring og administration af Kevzara.
English: • Take one pen out of the packaging by holding the middle of the pen body.
Danish: • Tag en pen ud af kartonen ved at holde midt på pennen.
English: Keep the carton in an insulated bag with an ice pack when travelling.
Danish: Opbevare kartonen i en køleboks/køletaske med køleelementer, når du er ude at rejse.
English: If it has been 4 days or more, inject the next dose at your regular time.
Danish: Hvis det er 4 dage eller mere siden den glemte dosis, skal du først injicere den næste dosis på det sædvanlige tidspunkt.
English: In patients experiencing a decrease in absolute neutrophil count (ANC), modification of treatment regimen such as interruption of Kevzara or reduction in dose resulted in an increase or normalization of ANC (see section 4.2).
Danish: Hos patienter, der oplevede fald i absolut neutrofiltal (ANC), resulterede behandlingsændringer, som f.eks. seponering af Kevzara eller dosisreduktion, i en stigning eller normalisering af ANC (se pkt.
English: RA patients have an increased risk for cardiovascular disorders and risk factors (e.g. hypertension, hyperlipidaemia) should be managed as part of usual standard of care.
Danish: Patienter med reumatoid artritis har øget risiko for kardiovaskulære sygdomme, og risikofaktorer (f.eks. hypertension og hyperlipidæmi) skal behandles efter gældende klinisk praksis.
English: Lay the pen on a flat surface and allow it to warm up to room temperature (<25°C) for at least 60 minutes.
Danish: Læg pennen på en plan flade, og lad den opnå stuetemperatur (<25°C) i mindst 60 minutter.
English: The impact of treatment with Kevzara on the development of malignancies is not known but malignancies were reported in clinical studies (see section 4.8).
Danish: Sammenhængen mellem behandling med Kevzara og udvikling af malignitet kendes ikke, men i kliniske studier er der rapporteret tilfælde med maligne sygdomme (se pkt.
English: Current dose of Kevzara should be maintained.
Danish: Nuværende dosis af Kevzara bibeholdes.
English: • warfarin, used to prevent blood clots If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist.
Danish: • warfarin, anvendes til at forebygge blodpropper Tal med lægen eller apotekspersonalet, hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl om, det gælder for dig).
English: Learning how to use the pre-filled pen
Danish: Sådan skal du bruge den fyldte pen
English: You will also have the tests during your treatment.
Danish: I løbet af behandlingen skal du også have taget blodprøver.
English: * q2w = every 2 weeks ‡ Visual analogue scale †p-value <0.01 for difference from placebo ††p-value <0.001 for difference from placebo †††p-value <0.0001 for difference from placebo
Danish: ‡ Visuel analogskala †p-værdi <0,01 for forskel fra placebo ††p-værdi <0,001 for forskel fra placebo †††p-værdi <0,0001 for forskel fra placebo
English: Dose modification:
Danish: Dosisjustering:
English: Figure 2: Percent of ACR20 Response by Visit for TARGET
Danish: Figur 2: Procent af ACR20-respons ved besøg vedr.