FrancophonIA/ELRC3.0 huggingface dataset:
English: Other medicines and Kevzara
Danish: Brug af anden medicin sammen med Kevzara
English: Kevzara should not be administered to patients with known hypersensitivity to sarilumab (see section 4.3).
Danish: Kevzara må ikke administreres til patienter med kendt overfølsomhed over for sarilumab (se pkt.
English: In the placebo-controlled population, malignancies occurred at the same rate in patients receiving either Kevzara + DMARDs or placebo + DMARDs (1.0 events per 100 patient-years).
Danish: I den placebokontrollerede population forekom malignitet med samme hyppighed hvad enten patienterne fik Kevzara + DMARDs eller placebo + DMARDs (1,0 hændelse pr. 100 patientår).
English: Various in vitro and limited in vivo human studies have shown that cytokines and cytokine modulators can influence the expression and activity of specific cytochrome P450 (CYP) enzymes (CYP1A2, CYP2C9, CYP2C19, and CYP3A4) and therefore have the potential to alter the pharmacokinetics of concomitantly administered medicinal products that are substrates of these enzymes.
Danish: Adskillige in vitro- og et begrænset antal in vivo-studier hos mennesker har vist, at cytokiner og cytokinmodulatorer kan påvirke specifikke CYP-P450-enzymers (CYP1A2, CYP2C9, CYP2C19 og CYP3A4) ekspression og aktivitet.
English: Treatment should be started by a doctor experienced in the diagnosis and treatment of rheumatoid arthritis.
Danish: Behandlingen bør påbegyndes af en læge med erfaring i diagnosticering og behandling af kronisk leddegigt.
English: The most frequently observed serious infections with Kevzara included pneumonia and cellulitis (see section 4.8).
Danish: De hyppigst observerede alvorlige infektioner i forbindelse med Kevzara omfatter pneumoni og cellulitis (se pkt.
English: • Use the pre-filled pen exactly as described in the “Instructions for Use”.
Danish: • Du skal altid bruge den fyldte pen præcist som beskrevet i ”Brugervejledningen”.
English: • infections in your sinuses or throat, blocked or runny nose and sore throat (upper respiratory tract infection)
Danish: • Infektion i bihulerne eller halsen, tilstoppet eller løbende næse og ondt i halsen (øvre luftvejsinfektion)
English: Patients receiving Kevzara 200 mg + DMARDs reported greater improvement relative to placebo in the domains of Physical Functioning, Role Physical, Bodily Pain, General Health Perception, Vitality, Social Functioning, and Mental Health.
Danish: Patienter, der fik Kevzara 200 mg + DMARDs viste større forbedring sammenlignet med placebo for SF-36 domænerne Fysisk funktion, Fysisk betingede begrænsninger, Fysiske smerter, Alment helbred, Energi, Sociale aktiviteter og Psykisk velbefindende.
English: It contains 150 mg of Kevzara for injection under the skin (subcutaneous injection) once every two weeks.
Danish: Den indeholder 150 mg Kevzara til injektion under huden (subkutan injektion) én gang hver 2. uge.
English: The recommended dose of Kevzara is 200 mg once every 2 weeks administered as a subcutaneous injection.
Danish: Dosering Den anbefalede dosis af Kevzara er 200 mg administreret én gang hver 2. uge som subkutan injektion.
English: For the 200 mg every two weeks dose regimen, the estimated mean (± SD) steady-state AUC, Cmin and Cmax of sarilumab were 396 ± 194 mg.day/L, 16.7 ± 13.5 mg/L, and 35.4 ± 13.9 mg/L, respectively.
Danish: I dosisregimet med 200 mg hver 2. uge var sarilumabs gennemsnitlige estimerede (± SD) steady-state AUC, Cmin og Cmax henholdsvis 396 ± 194 mg*dag/l, 16,7 ± 13,5 mg/l og 35,4 ± 13,9 mg/l.
English: Pinch the skin.
Danish: Klem huden sammen.
English: • Using the syringe at room temperature may make the injection more comfortable.
Danish: • Hvis sprøjten har fået stuetemperatur, kan indsprøjtningen føles mere behagelig.
English: Lay the syringe on a flat surface and allow it to warm up to room temperature (<25°C) for at least 30 minutes.
Danish: Læg sprøjten på en plan flade, og lad den opnå stuetemperatur (<25°C) i mindst 30 minutter.
English: Boulevard Industriel, Zone Industrielle, Le Trait, 76580,
Danish: Sanofi Winthrop Industrie Boulevard Industriel, Zone Industrielle, Le Trait, 76580,
English: This device is a single-dose pre-filled syringe (called “syringe” in these instructions).
Danish: Denne anordning er en enkeltdosis fyldt injektionssprøjte (kaldes “sprøjte” i denne vejledning).
English: * q2w=every two weeks † p-value <0.001 ††p-value <0.0001 ‡ Primary end point
Danish: † p-værdi <0,001 †† p-værdi <0,0001 ‡ Primært endepunkt
English: If you are unsure when to inject your next dose: ask your doctor, pharmacist or nurse for instructions.
Danish: Hvis du er i tvivl om, hvornår du skal injicere den næste dosis, skal du spørge lægen, apotekspersonalet eller sundhedspersonalet til råds.
English: In both studies, patients treated with either 200 mg or 150 mg of Kevzara + DMARDs every two weeks had higher ACR20, ACR50, and ACR70 response rates versus placebo-treated patients at Week 24.
Danish: I begge studier oplevede de patienter, der fik enten 200 mg eller 150 mg Kevzara + DMARDs hver 2. uge højere ACR20-, ACR50- og ACR70responsrater versus placebobehandlede patienter ved uge 24.
English: Let the syringe warm up to room temperature for at least 30 minutes before using.
Danish: Lade sprøjten opnå stuetemperatur i mindst 30 minutter før brug.
English: • Hold the syringe in the middle of the syringe body with the needle pointing away from you.
Danish: • Hold sprøjten midt på cylinderen, så kanylen peger væk fra dig.
English: Treatment with Kevzara should be discontinued.
Danish: Behandling med Kevzara skal seponeres.
English: For further details on administration of this medicinal product see section 6.6.
Danish: For instruktioner om administration af lægemidlet, se pkt.
English: For recommended dose modifications based on ANC results see section 4.2.
Danish: 4.2 for anbefalede dosisændringer baseret på ANC-resultater.
English: Patients should be closely monitored for the development of signs and symptoms of tuberculosis including patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Danish: Patienter skal følges tæt for tegn og symptomer på tuberkulose, herunder patienter som er testet negative for latent tuberkulose før behandling med Kevzara.
English: • you have had diverticulitis (a condition of the lower bowel) or ulcers in your stomach or intestines, or develop symptoms such as fever and stomach (abdominal) pain that does not go away.
Danish: • hvis du har haft betændelse i en udposning i den nedre del af tyktarmen (diverculitis) eller sår i mave-tarm-kanalen eller får symptomer som f.eks. feber og mavesmerter, som ikke forsvinder af sig selv.
English: What Kevzara is used for
Danish: Hvad anvendes Kevzara til?
English: The MAH shall ensure that in each Member State where Kevzara is marketed, all healthcare professionals who are expected to prescribe Kevzara have access to the patient alert card.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, der forventes at ordinere Kevzara, forsynes med patientkort.
English: • IL-6 plays a major role in the symptoms of rheumatoid arthritis such as pain, swollen joints,
Danish: • IL-6 spiller en vigtig rolle i symptomerne på kronisk leddegigt som f.eks. smerter, hævede led, morgenstivhed og træthed.
English: Reduction of dose from 200 mg once every 2 weeks to 150 mg once every 2 weeks is recommended for management of neutropenia, thrombocytopenia, and liver enzyme elevations.
Danish: Dosisreduktion fra 200 mg én gang hver 2. uge til 150 mg én gang hver 2. uge anbefales i tilfælde af neutropeni, trombocytopeni og forhøjede niveauer af leverenzymer.
English: It contains 200 mg of Kevzara for injection under the skin (subcutaneous injection) once every two weeks.
Danish: Den indeholder 200 mg Kevzara til injektion under huden (subkutan injektion) én gang hver 2. uge.
English: In patients who develop an ANC less than 0.5 x 109/L, treatment with Kevzara should be discontinued.
Danish: Hos patienter, der får et ANC under 0,5 x 109/l, skal behandlingen med Kevzara seponeres.
English: Hypersensitivity reactions have been reported in association with Kevzara (see section 4.8).
Danish: Der er rapporteret overfølsomhedsreaktioner i forbindelse med Kevzara (se pkt.
English: • abnormal liver function tests
Danish: • Unormale leverfunktionsværdier
English: If you have any further questions, ask your doctor, pharmacist or nurse or call the sanofi number on the package leaflet.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet eller ring til sanofi på det telefonnummer, der står i indlægssedlen.
English: Lipid parameters should be assessed approximately 4 to 8 weeks following initiation of treatment with Kevzara, then at approximately 6 month intervals.
Danish: Lipidparametre skal kontrolleres ca. 4-8 uger efter behandlingsstart med Kevzara og derefter ca. hver 6. måned.
English: For the 150 mg every two weeks dose regimen, the estimated mean (± standard deviation, SD) steadystate area under curve (AUC), Cmin, and Cmax of sarilumab were 210 ± 115 mg.day/L, 6.95 ± 7.60 mg/L, and 20.4 ± 8.27 mg/L, respectively.
Danish: I dosisregimet med 150 mg hver 2. uge var sarilumabs gennemsnitlige estimerede (± standardafvigelse, SD) steady-state AUC (areal under kurven), Cmin, og Cmax henholdsvis 210 ± 115 mg*dag/l, 6,95 ± 7,60 mg/l og 20,4 ± 8,27 mg/l.
English: Patients should be closely monitored for the development of signs and symptoms of infection during treatment with Kevzara (see sections 4.2 and 4.8).
Danish: Patienter skal monitoreres tæt for udvikling af tegn og symptomer på infektion under behandling med Kevzara (se pkt.
English: Kevzara should not be injected into skin that is tender, damaged, or has bruises or scars.
Danish: Kevzara må ikke injiceres i øm eller beskadiget hud eller i hud med blå mærker eller ar.
English: • Always keep the container out of the sight and reach of children.
Danish: • Opbevar altid kanylebeholderen utilgængeligt for børn.
English: • you have any infection or you get a lot of infections.
Danish: • hvis du har en infektion eller du tit får infektioner.
English: In the Kevzara + DMARDs long-term safety population, the rate of GI perforations was 0.14 events per 100 patient-years.
Danish: I langtidssikkerhedspopulationen med Kevzara + DMARDs var hyppigheden af gastrointestinale perforeringer 0,14 hændelser pr. 100 patientår.
English: Body weight influenced the pharmacokinetics of sarilumab.
Danish: Kropsvægt er vist at påvirke sarilumabs farmakokinetik.
English: • Use the pre-filled syringe exactly as described in the “Instructions for Use”.
Danish: • Du skal bruge den fyldte injektionssprøjte præcist som beskrevet i ”Brugervejledningen”.
English: Kevzara Monotherapy Any Dose N = 467
Danish: Kevzara monoterapi Uanset dosis N = 467
English: ALT and AST levels should be monitored 4 to 8 weeks after start of therapy and every 3 months thereafter.
Danish: ALAT- og ASAT-niveauer bør monitoreres 4-8 uger efter behandlingsstart og derefter hver 3. måned.
English: These elevations were transient and did not result in any clinically evident hepatic injury in clinical studies (see section 4.8).
Danish: Disse forhøjelser var forbigående, og i kliniske studier resulterede de ikke i nogen form for klinisk påviste leverskader (se pkt.
English: • Take one syringe out of the packaging by holding the middle of the syringe body.
Danish: • Tag en sprøjte ud af kartonen ved at holde midt på cylinderen.
English: Store pre-filled syringe/pre-filled pen in the original carton in order to protect from light.
Danish: Opbevar den fyldte injektionssprøjte/fyldte pen i den originale karton for at beskytte mod lys.
English: Treatment with Kevzara should be withheld until >100 x 103/µL.
Danish: Behandling med Kevzara afbrydes indtil trombocyttallet er >100 x 103/µl.
English: Do not use the syringe if the date has passed.
Danish: Du må ikke bruge sprøjten, hvis udløbsdatoen er overskredet.
English: Patients receiving Kevzara 200 mg or 150 mg + DMARDs every two weeks demonstrated greater improvement from baseline in physical function compared to placebo at Week 16 and Week 12 in MOBILITY and TARGET, respectively.
Danish: Patienter, der fik Kevzara 200 mg eller 150 mg + DMARDs hver 2. uge viste en større forbedring fra baseline i fysisk funktionsevne sammenlignet med placebo ved uge 16 og uge 12 i henholdsvis MOBILITY og TARGET.
English: • you have any infection or, you get a lot of infections.
Danish: • hvis du har en infektion, eller du tit får infektioner.
English: • Change injection site each time you inject.
Danish: • Vælg et nyt injektionssted til hver injektion.
English: • low platelet counts shown by blood tests
Danish: • Lavt antal blodplader, som ses i en blodprøve
English: For recommended dose modifications based on transaminase elevations see section 4.2.
Danish: 4.2 for anbefalede dosisændringer baseret på transaminaseforhøjelser.
English: Reduction in platelets was not associated with bleeding events (see section 4.8).
Danish: Fald i antallet af trombocytter var ikke forbundet med tilfælde af blødning (se pkt.
English: Kevzara is a clear, colourless to pale yellow solution for injection that comes in a pre-filled pen.
Danish: Kevzara er en klar, farveløs til lys gullig injektionsvæske, som fås i en fyldt pen.
English: Initiating treatment with Kevzara is not recommended in patients with elevated transaminases, ALT or AST greater than 1.5 x ULN.
Danish: Behandling med Kevzara bør ikke indledes hos patienter med forhøjet transaminase, ALAT eller ASAT over 1,5 x ULN.
English: The solution should not be used if it is cloudy, discoloured, or contains particles, or if any part of the device appears to be damaged.
Danish: Opløsningen må ikke anvendes, hvis den er uklar, misfarvet eller indeholder partikler, eller hvis en del af anordningen ser ud til at være beskadiget.
English: Read all of the instructions carefully before using a syringe.
Danish: Læse hele vejledningen grundigt, før du bruger sprøjten.
English: Patients received Kevzara 200 mg, Kevzara 150 mg, or placebo every 2 weeks with concomitant conventional DMARDs (cDMARDs).
Danish: Patienterne fik Kevzara 200 mg, Kevzara 150 mg eller placebo hver 2. uge samtidigt med konventionelle DMARDs (cDMARDs).
English: Among opportunistic infections, tuberculosis, candidiasis, and pneumocystis were reported with Kevzara.
Danish: Nogle af de opportunistiske infektioner, der er rapporteret i forbindelse med Kevzara, er tuberkulose, candidiasis og pneumocystis.
English: • Pull the needle out at the same angle it was injected.
Danish: • Træk kanylen ud i samme vinkel, som du stak den i huden.
English: If a dose of Kevzara is missed and it has been 3 days or less since the missed dose, the next dose should be administered as soon as possible.
Danish: Hvis en dosering Kevzara er blevet glemt i højst 3 dage, skal den administreres hurtigst muligt.
English: In the Kevzara monotherapy population, observations were consistent with the Kevzara + DMARDs population.
Danish: I populationen med Kevzara monoterapi svarede observationerne til observationerne i populationen med Kevzara + DMARDs.
English: Put the yellow needle cover on your skin at roughly a 90° angle.
Danish: Tryk det gule kanylebeskyttelseshylster vinkelret (90°) på huden.
English: It is available in pack sizes of 1 or 2 or a multipack of 6 pre-filled pens (3 packs of 2).
Danish: Den fås i pakninger med 1 eller 2 eller en multipakning med 6 fyldte penne (3 pakninger med hver 2).
English: Avoid concurrent use of live vaccines as well as live attenuated vaccines during treatment with Kevzara as clinical safety has not been established.
Danish: Levende vacciner og levende, svækkede vacciner bør ikke gives samtidigt med Kevzara, da den kliniske sikkerhed ikke er dokumenteret.
English: In patients who develop elevated ALT greater than 5 x ULN, treatment with Kevzara should be discontinued (see section 4.2).
Danish: Hos patienter, som udvikler forhøjet ALAT over 5 x ULN, skal behandling med Kevzara seponeres (se pkt.
English: Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Do not freeze or heat the pen.
Danish: Nedfryse eller opvarme pennen.
English: In the placebo-controlled population, 4.0%, 5.6%, and 2.0% of patients treated with Kevzara 200 mg + DMARDs, Kevzara 150 mg + DMARDs and placebo + DMARDs respectively, exhibited a positive response in the anti-drug antibody (ADA) assay.
Danish: I den placebokontrollerede population udviste 4,0%, 5,6% og 2,0% af de patienter, der blev behandlet med henholdsvis Kevzara 200 mg + DMARDs, Kevzara 150 mg + DMARDs og placebo + DMARDs, positivt respons i anti-lægemiddel-antistof (ADA)-analysen.
English: In MOBILITY and TARGET, patients receiving Kevzara 200 mg + DMARDs every two weeks or Kevzara 150 mg + DMARDs every two weeks demonstrated greater improvement from baseline compared to placebo + DMARDs in physical component summary (PCS) and no worsening on the mental component summary (MCS) at Week 24.
Danish: I MOBILITY og TARGET viste patienter, der fik Kevzara 200 mg + DMARDs hver 2. uge eller Kevzara 150 mg + DMARDs hver 2. uge, større forbedring fra baseline sammenlignet med placebo + DMARDs i physical component summary (PCS) og ingen forværring i mental component summary (MCS) ved uge 24.
English: In the placebo-controlled population, injection site reactions were reported in 9.5%, 8%, and 1.4% of patients receiving Kevzara 200 mg, 150 mg, and placebo respectively.
Danish: I den placebokontrollerede population blev reaktioner på injektionsstedet rapporteret hos 9,5%, 8%, og 1,4% af de patienter, der fik henholdsvis Kevzara 200 mg, 150 mg og placebo.
English: The overall rates of infections and serious infections in the Kevzara monotherapy population were consistent with rates in the Kevzara + DMARDs population.
Danish: Den overordnede hyppighed af infektioner og alvorlige infektioner i populationen, der fik Kevzara monoterapi svarede til hyppigheden i populationen, der fik Kevzara + DMARDs.
English: Treatment with Kevzara should be withheld until >1 x 109/L.
Danish: Behandling med Kevzara afbrydes indtil ANC-værdien er >1 x 109/l.
English: In 17 patients with RA, one week following a single 200-mg subcutaneous administration of sarilumab, exposure of simvastatin and simvastatin acid decreased by 45% and 36%, respectively (see section 4.5).
Danish: Hos 17 patienter med RA mindskedes eksponeringen for simvastatin og simvastatinsyre med henholdsvis 45% og 36% en uge efter en enkelt subkutan administration af 200 mg sarilumab (se pkt.
English: Before you use Kevzara, your doctor will do a blood test to check your liver function.
Danish: Din læge vil tage en blodprøve for at kontrollere din leverfunktion, før du bruger Kevzara.
English: Instructions for use
Danish: Brugervejledning
English: In MOBILITY and TARGET, patients receiving sarilumab 200 mg + DMARDs every two weeks or sarilumab 150 mg + DMARDs every two weeks demonstrated greater improvement from baseline compared to placebo + DMARDs.
Danish: I MOBILITY og TARGET viste patienter, der fik sarilumab 200 mg + DMARDs hver 2. uge eller sarilumab 150 mg + DMARDs hver 2. uge, større forbedring fra baseline sammenlignet med placebo + DMARDs.
English: In patients who develop a platelet count less than 50 x 103/ µL, treatment with Kevzara should be discontinued.
Danish: Hos patienter, som udvikler et trombocyttal under 50 x 103/µl, skal behandling med Kevzara seponeres.
English: Put your used syringe and the cap into a puncture-resistant container right away after use.
Danish: Læg den brugte sprøjte og kanylehætte i en kanylebeholder straks efter brug.
English: In patients experiencing liver enzyme elevation, modification of treatment regimen, such as interruption of Kevzara or reduction in dose, resulted in decrease or normalization of liver enzymes (see section 4.2).
Danish: Hos patienter, der oplevede forhøjede leverenzymværdier, resulterede behandlingsændringer, som f.eks. seponering af Kevzara eller dosisnedsættelse, i reduktion eller normalisering af leverenzymværdier (se pkt.
English: No formal study of the effect of hepatic impairment on the pharmacokinetics of sarilumab was conducted (see section 4.2).
Danish: Der er ikke udført formelle studier vedrørende betydningen af nedsat leverfunktion på sarilumabs farmakokinetik (se pkt.
English: • Neutrophil count should be monitored 4 to 8 weeks after start of therapy and according to clinical judgment thereafter.
Danish: • Neutrofiltal bør monitoreres 4-8 uger efter behandlingsstart og derefter i henhold til en klinisk vurdering.
English: Animal studies showed no impairment of male or female fertility (see section 5.3).
Danish: Dyrestudier viste ikke nedsat fertilitet hos hverken hanner eller hunner (se pkt.
English: Kevzara 150 mg + cDMARD
Danish: Kevzara 150 mg + cDMARDs
English: • other biological medicines used in the treatment of rheumatoid arthritis If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist.
Danish: • anden biologisk medicin til behandling af kronisk leddegigt Tal med lægen eller apotekspersonalet, hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl om, det gælder for dig).
English: Serious side effect
Danish: Alvorlige bivirkninger
English: No formal study of the effect of renal impairment on the pharmacokinetics of sarilumab was conducted.
Danish: Der er ikke udført formelle studier vedrørende betydningen af nedsat nyrefunktion på sarilumabs farmakokinetik.
English: Physical function response
Danish: Ændring i fysisk funktion
English: Kevzara 200 mg + cDMARD
Danish: Kevzara 200 mg + cDMARDs
English: Do not expose the syringe to direct sunlight.
Danish: Du må ikke udsætte sprøjten for direkte sollys.
English: Kevzara is a clear, colourless to pale yellow solution for injection that comes in a pre-filled syringe.
Danish: Kevzara er en klar, farveløs til lys gullig injektionsvæske, som fås i en fyldt injektionssprøjte.
English: Each pre-filled pen contains 1.14 ml of solution delivering one single dose.
Danish: Hver fyldt pen indeholder 1,14 ml opløsning, der giver en enkelt dosis.
English: This is because Kevzara can affect the way some other medicines work.
Danish: Kevzara kan påvirke virkningen af anden medicin.
English: Do not try to put the cap back on a pen.
Danish: Forsøge at sætte hætten tilbage på pennen.
English: After use, put the pen into a puncture-resistant container.
Danish: Efter brug lægges pennen i en kanylebeholder.
English: Recommended dose modifications in case of neutropenia, thrombocytopenia, or liver enzyme elevations (see sections 4.4 and 4.8):
Danish: Anbefalede dosisjusteringer i tilfælde af neutropeni, trombocytopeni og forhøjede niveauer af leverenzymer (se pkt.
English: Initiating treatment with Kevzara is not recommended in patients with a low neutrophil count, i.e., absolute neutrophil count (ANC) less than 2 x 109/L.
Danish: Behandling med Kevzara bør ikke påbegyndes hos patienter med lavt neutrofiltal, dvs. absolut neutrofiltal (ANC) under 2 x 109/l.
English: Keep unused syringes in the original carton and store in the refrigerator between 2ºC and 8ºC.
Danish: Opbevare ubrugte sprøjter i den originale karton i køleskabet (2ºC-8ºC).
English: • injection site reactions (including redness and itching)
Danish: • Reaktioner omkring injektionsstedet (f.eks. rødme og kløe).
English: Keep unused pens in the original carton and store in the refrigerator between 2ºC and 8ºC.
Danish: Opbevare ubrugte penne i den originale karton i køleskabet (2ºC-8ºC).
English: Do not recycle the container.
Danish: Du må ikke genbruge kanylebeholderen.
English: Name and address of the manufacturer of the biological active substance Regeneron Pharmaceuticals Inc.
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof