FrancophonIA/ELRC3.0 huggingface dataset:
English: • According to a pregnancy study, there was no higher risk of birth defects when the mother had received AMGEVITA during pregnancy compared with mothers with the same disease who did not receive AMGEVITA.
Danish: • Der var i følge et graviditetsstudie ikke højere risiko for misdannelser, når moderen havde fået AMGEVITA under graviditeten, ved sammenligning med mødre med samme sygdom, som ikke havde fået AMGEVITA.
English: The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomised design.
Danish: Fortolkningen af data af kan være påvirket af studiet metodoligiske begrænsninger, inklusive lille prøvegruppe og ikke-randomiseret design.
English: PGA-F clear/minimal and ≥ 2-grade improvement
Danish: PGA-F clear/minimal og ≥ 2 grader forbedring (%)
English: Grab Here
Danish: Tag fat her
English: You and your doctor should pay special attention to signs of infection while you are being treated with AMGEVITA.
Danish: Du og din læge bør være særligt opmærksomme på tegn på infektion mens du er i behandling med AMGEVITA.
English: Note: After you remove the pre-filled pen from your skin, the needle will be automatically covered.
Danish: Bemærk: Når du har fjernet den fyldte pen fra huden, dækkes kanylen automatisk.
English: ATC code: L04AB04
Danish: ATCkode: L04AB04
English: treated.
Danish: behandlede.
English: Carefully lift the pre-filled pen straight up out of the box.
Danish: Løft forsigtigt den fyldte pen lige ud af kassen.
English: Significant response was first observed at week 2 and maintained through 24 weeks (table
Danish: Første signifikante respons blev observeret ved uge 2 og blev opretholdt frem til uge 24 (Tabel 13).
English: • severe allergic reaction with shock;
Danish: • alvorlig allergisk reaktion med shock,
English: In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding.
Danish: - Hos nogle patienter vil kroppen ikke producere tilstrækkeligt af de blodlegemer, som hjælper kroppen med at bekæmpe infektioner eller stoppe blødninger.
English: AMGEVITA in combination with methotrexate, is indicated for:
Danish: AMGEVITA i kombination med methotrexat er indiceret til:
English: Important: Needle is inside
Danish: Vigtigt: Kanylen er indeni
English: For safety reasons:
Danish: Af hensyn til din sikkerhed:
English: Important: When you remove the pre-filled pen, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose.
Danish: Vigtigt: Hvis ruden ikke er blevet gul, når du har fjernet den fyldte pen, eller hvis det ser ud til, at medicinen stadig injiceres, betyder det, at du ikke har fået en hel dosis.
English: If you are over 65 years you may be more susceptible to infections while taking AMGEVITA.
Danish: - Hvis du er over 65 år, kan du være mere modtagelig for infektioner, mens du tager AMGEVITA.
English: if you have moderate or severe heart failure.
Danish: - Hvis du lider af moderat eller alvorlig hjerteinsufficiens.
English: ● If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.
Danish: ● Hvis du ønsker at bruge samme injektionssted, så sørg for, at det ikke er nøjagtigt samme sted som ved sidste injektion.
English: You should continue to inject AMGEVITA for as long as your doctor has told you.
Danish: Du skal fortsætte med at injicere AMGEVITA så længe, din læge har fortalt dig.
English: The patients in HS-I and HS-II had Hurley Stage II or III disease with at least 3 abscesses or inflammatory nodules.
Danish: Patienterne i HS-I og HS-II havde sygdommen i Hurley-stadie II eller III med mindst 3 abscesser eller inflammatoriske noduli.
English: AMGEVITA is a biosimilar medicinal product.
Danish: AMGEVITA er et biosimilært lægemiddel.
English: Reactivation of hepatitis B1), Autoimmune hepatitis1)
Danish: Reaktivering af hepatitis B1), Autoimmun hepatit1)
English: Important: Do not touch the blue start button yet.
Danish: Vigtigt: Rør ikke ved den blå startknap endnu.
English: Step 4: Finish K. Discard the used pre-filled pen and the yellow cap.
Danish: Trin 4: Afslut K. Kassér den brugte pen og den gule hætte.
English: if you have a severe infection, including active tuberculosis (see “Warnings and precautions”).
Danish: - Hvis du har en alvorlig infektion, herunder aktiv tuberkulose (se ”Advarsler og forsigtighedsregler”).
English: b 2-sided P value from log rank test. c NE = not estimable.
Danish: b 2-sidet p-værdi fra log rank test. c NE = ikke estimerbar.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 March 2017
Danish: Dato for første markedsføringstilladelse: 22. marts 2017
English: AMGEVITA works by reducing this inflammation.
Danish: AMGEVITA virker ved at reducere denne inflammation.
English: Your doctor should test you for HBV. AMGEVITA can cause reactivation of HBV in people who carry this virus.
Danish: Lægen vil teste dig for HBV. AMGEVITA kan forårsage reaktivering af HBV hos mennesker, der bærer denne virus.
English: In all situations described below, the benefit/risk balance of therapy should be very carefully considered.
Danish: I alle disse situationer beskrevet nedenfor skal balancen mellem fordele/ulemper ved behandling tages meget nøje i betragtning.
English: The primary endpoint of the study was clinical remission at week 26, defined as PCDAI score ≤ 10.
Danish: Studiets primære effektmål var klinisk remission ved uge 26, defineret som PCDAI score ≤ 10.
English: Ps study IV efficacy results at 16, 26 and 52 weeks
Danish: Ps-studie IV - effektresultater ved uge 16, 26 og 52
English: TNF-antagonists, such as AMGEVITA affect the immune system and their use may affect the body's defence against infection and cancer.
Danish: TNF-antagonister, så som AMGEVITA påvirker immunsystemet og brugen af dem kan påvirke kroppens forsvar mod infektion og cancer.
English: • new onset or worsening of psoriasis;
Danish: • nye udbrud eller forværring af psoriasis,
English: NA 9.5% 41.5%
Danish: NA NA NA 9,5 % 41,5 %
English: The window turns yellow When the injection is done
Danish: Ruden bliver gul, når injektionen er færdig
English: Longer term treatment with adalimumab 40 mg weekly for 96 weeks identified no new safety findings.
Danish: Langtidsbehandling med adalimumab 40 mg ugentligt i 96 uger viste ingen nye sikkerhedsfund.
English: Your doctor will decide if you should receive AMGEVITA.
Danish: Din læge vil tage stilling til, om du skal have AMGEVITA.
English: You should not take AMGEVITA with medicines containing the active substances, anakinra or abatacept due to increased risk of serious infection.
Danish: Du bør ikke tage AMGEVITA sammen med medicin, der indeholder det aktive stof anakinra eller abatacept på grund af den forhøjede risiko for alvorlig infektion.
English: Hidradenitis Suppurativa Clinical Response (HiSCR)a
Danish: Hidradenitis Suppurativa Clinical Respons (HiSCR)a
English: By attaching to TNFα, AMGEVITA decreases the process of inflammation in these diseases.
Danish: Ved at binde sig til TNFα reducerer AMGEVITA den inflammatoriske proces i disse sygdomme.
English: - Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before you are given AMGEVITA and during treatment with AMGEVITA.
Danish: - Din læge vil også udlevere et patientkort, der indeholder vigtige sikkerhedsinformationer, som du skal være opmærksom på før og under din behandling med AMGEVITA.
English: Over all 19 subjects, of which 11 of the baseline age group 4 to 12 and 8 of the baseline age group 13 to 17 years were treated 6 years or longer.
Danish: I alt blev 19 forsøgspersoner, heraf 11 fra baseline-aldersgruppen 4 til 12 år og 8 fra baselinealdersgruppen 13 til 17 år, behandlet i 6 år eller mere.
English: The corresponding proportions of patients with no radiographic progression were 31.3%, 23.7% and 36.7% respectively.
Danish: Den tilsvarende andel af patienter uden radiografisk progression var henholdvis 31,3 %, 23,7 % og 36,7 %.
English: Clinical remission results remained relatively constant irrespective of previous TNF-antagonist exposure.
Danish: Raterne for klinisk remission forblev forholdvis konstante uanset tidligere TNF-antagonist-eksposition.
English: - if you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for adalimumab eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: ● Do not leave the syringe in direct sunlight.
Danish: ● Lad ikke sprøjten ligge i direkte sollys.
English: Certain vaccines may cause infections and should not be given while receiving AMGEVITA.
Danish: - Visse vacciner kan forårsage infektioner og bør ikke gives under AMGEVITA-behandling.
English: After 32 weeks or at disease flare, patients were eligible to enrol into the open-label extension phase.
Danish: Efter 32 uger eller ved opblussen af sygdommen var patienterne egnede til inklusion i den åbne forlængelsesfase.
English: If retreatment with AMGEVITA is indicated, the above guidance on dose and treatment duration should be followed.
Danish: Hvis genbehandling med AMGEVITA er indiceret, bør ovenstående vejledning for dosering og behandligsvarighed følges.
English: Name and address of the manufacturers of the biological active substance Amgen Inc
Danish: Navn og adresse på fremstillerne af det biologisk aktive stof Amgen Inc
English: AMGEVITA is intended for the treatment of the inflammatory diseases described below:
Danish: AMGEVITA er beregnet til behandlingen af de inflammatoriske sygdomme beskrevet nedenfor:
English: Re-introduction of AMGEVITA after discontinuation for 70 days or longer should result in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Danish: Genopstart af AMGEVITA efter doseringsindstilling i 70 dage eller længere bør resultere i et klinisk respons i samme størrelsesorden og med samme sikkerhedsprofil som før behandlingsafbrydelsen.
English: Please check with your doctor before you receive any vaccines.
Danish: Tal med lægen, før du får nogen form for vaccine.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til subkutan anvendelse.
English: AMGEVITA contains sodium
Danish: AMGEVITA indeholder natrium
English: Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of contracting HBV.
Danish: - Fortæl lægen, hvis du er bærer af hepatitis B-virus (HBV), hvis du har aktiv HBV, eller hvis du tror, du kan have risiko for at få HBV.
English: If you received AMGEVITA while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last dose you received during pregnancy.
Danish: Hvis du har fået AMGEVITA, mens du var gravid, kan dit spædbarn have en højere risiko for at få en sådan infektion i op til ca. fem måneder efter din sidste dosis under graviditeten.
English: Appropriate screening tests (i.e. tuberculin skin test and chest x-ray) should be performed in all patients (local recommendations may apply).
Danish: Passende screeningsundersøgelser (dvs. tuberkulinhudtest og røntgen af thorax) bør foretages hos alle patienter (i henhold til lokale anbefalinger).
English: • cancer that affects the lymph system;
Danish: • kræft, der rammer lymfesystemet,
English: • high blood sugar;
Danish: • højt blodsukker,
English: Step 2: Get ready
Danish: Trin 2: Vær parat
English: Treatment with AMGEVITA may result in the formation of autoimmune antibodies.
Danish: Behandling med AMGEVITA kan medføre dannelse af autoimmune antistoffer.
English: Avoid injecting into areas with scars or stretch marks.
Danish: Undgå at injicere i områder med ar eller strækmærker.
English: After proper training in injection technique, patients may self-inject with AMGEVITA 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 AMGEVITA, såfremt lægen finder det hensigtsmæssigt, og med nødvendig lægelig opfølgning.
English: The potential risk with the combination of azathioprine or 6-mercaptopurine and AMGEVITA should be carefully considered.
Danish: Den potentielle risiko ved kombination af azathioprin eller 6-mercaptopurin med AMGEVITA bør nøje overvejes.
English: Due to its inhibition of TNFα, adalimumab administered during pregnancy could affect normal immune responses in the new born.
Danish: På grund af sin TNFα-hæmmende virkning kan adalimumab administreret under graviditet påvirke de normale immunresponser hos nyfødte.
English: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with AMGEVITA.
Danish: Patienter skal derfor monitoreres nøje for infektioner, herunder tuberkulose, før, under og efter behandling med AMGEVITA.
English: Patients on AMGEVITA may receive concurrent vaccinations, except for live vaccines.
Danish: Patienter i AMGEVITA-behandling kan modtage samtidige vaccinationer, undtagen med levende vacciner.
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from baseline) rates are presented in table 26.
Danish: Rater for klinisk remission og klinisk respons (defineret som reduktion i PCDAI-score på mindst 15 point fra baseline) er vist i tabel 26.
English: Dry natural rubber
Danish: Tørt naturgummi
English: Maintenance of remission and response rates are presented in table 24.
Danish: Rater for vedligeholdelse af remission- og respons er vist i tabel 24.
English: Clinical remission is Mayo score ≤ 2 with no subscore > 1;
Danish: Klinisk remission er Mayo-score <2 uden subscore >1;
English: Maintenance regimen
Danish: Vedligeholdelsesregimen
English: AMGEVITA may have a minor influence on the ability to drive and use machines.
Danish: AMGEVITA kan have en mindre påvirkning af evnen til at føre motorkøretøj og betjene maskiner.
English: • swollen face, hands, feet;
Danish: • hævelser i ansigt, hænder eller fødder,
English: Step 1: Prepare
Danish: Trin 1: Forbered dig
English: Vertigo and visual impairment may occur following administration of AMGEVITA (see section 4.8).
Danish: Vertigo og svækket syn kan forekomme efter administration af AMGEVITA, se pkt 4.8.
English: ● If you have psoriasis, you should avoid injecting directly into raised, thick, red, or scaly skin patch or lesion.
Danish: ● Hvis du har psoriasis, skal du undgå at injicere direkte ind i hævede, tykke, røde eller skællende hudpletter eller hudskader.
English: - The pre-filled pen has been dropped on a hard surface.
Danish: - Den fyldte pen har været tabt på en hård flade.
English: This will include a thorough medical evaluation including your medical history and appropriate screening tests (for example chest x-ray and a tuberculin test).
Danish: Dette vil omfatte en omhyggelig gennemgang af din sygdomshistorie, relevante screeningstest (f. eks. røntgenundersøgelse af lunger og en tuberkulintest).
English: Disease flare criteria were defined as a worsening of ≥ 30% from baseline in ≥ 3 of 6 paediatric ACR core criteria, ≥ 2 active joints, and improvement of > 30% in no more than 1 of the 6 criteria.
Danish: Kriterier for opblussen af sygdommen var defineret som en forværring på ≥ 30 % i forhold til baseline af ≥ 3 ud af 6 pædiatrisk ACR- hovedkriterier, ≥ 2 aktive led og en forbedring på > 30 % i ikke mere end 1 af de 6 kriterier.
English: This is part of the syringe.
Danish: Det er en del af sprøjten.
English: In order to improve the traceability of this medicine, your doctor or pharmacist should record the name and the lot number of the product you have been given in your patient file.
Danish: Af hensyn til sporbarheden af dette lægemiddel bør din læge eller apotekspersonalet registrere navnet og lotnummeret på det produkt, du har fået, i din patientjournal.
English: If you have mild heart failure and you are being treated with AMGEVITA, your heart failure status must be closely monitored by your doctor.
Danish: - Hvis du har lettere hjerteinsufficiens og bliver behandlet med AMGEVITA, skal status for din hjerteinsufficiens følges nøje af din læge.
English: At week 12 and week 24, PedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach.
Danish: Ved uge 12 og uge 24 var pædiatrisk ACR 30-respons henholdsvis 93,5 % og 90,0 % ved anvendelse af observerede data.
English: C. Gather all materials needed for your injection.
Danish: C. Saml alle de materialer, du skal bruge til injektionen.
English: AMGEVITA is used to treat
Danish: AMGEVITA bruges til at behandle
English: Week 26 Placebo-controlled
Danish: Uge 26 Placebokontrolleret
English: Week 16 Placebo-controlled
Danish: Uge 16 Placebokontrolleret
English: Blue start button
Danish: Blå startknap
English: The impact of long-term treatment with AMGEVITA on the development of autoimmune diseases is unknown.
Danish: Det vides ikke, hvilken virkning langtidsbehandling med AMGEVITA har på udviklingen af autoimmune sygdomme.
English: Alopecia1),
Danish: Alopeci1),
English: It is important that you tell your baby's doctors and other health care professionals about your AMGEVITA use during your pregnancy so they can decide when your baby should receive any vaccine.
Danish: Det er vigtigt, at du fortæller barnets læge og andre sundhedspersoner, at du fik AMGEVITA under graviditeten, så de kan beslutte, hvornår dit spædbarn bør vaccineres.
English: 6.6 Special precautions for disposal and other handling Detailed instructions for use are provided in the package leaflet.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Indlægssedlen indeholder detaljerede instruktioner til anvendelsen.
English: You will also need these additional items, as they are not included in the carton:
Danish: Du skal også bruge disse materialer, som ikke følger med i pakningen:
English: AMGEVITA should be used with caution in patients with mild heart failure (NYHA class I/II).
Danish: AMGEVITA bør anvendes med forsigtighed til patienter med let hjerteinsufficiens (NYHA, klasse I/II).
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in table 6 below: 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); and not known (cannot be estimated from the available data).
Danish: Nedenstående liste over bivirkninger er baseret på erfaring fra kliniske studier og erfaring efter markedsføring og er inddelt efter organklassesystem og hyppighed i tabel 6 nedenfor meget almindelig (≥1/10); almindelig (≥1/100 til < 1/10); ikke almindelig (≥1/1.000 til < 1/100), sjælden (≥1/10.000 til < 1/1.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Treatment with AMGEVITA should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Danish: Behandling med AMGEVITA bør ikke initieres hos patienter med aktive infektioner, herunder kroniske eller lokaliserede infektioner, før infektionerne er under kontrol.
English: • autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);
Danish: • autoimmun hepatit (leverbetændelse forårsaget af kroppens eget immunsystem),
English: 1 p value for standard dose versus low dose comparison
Danish: 1 p-værdi for sammeligning af standard-dosis versus lav-dosis.
English: CD study II: infliximab experienced patients
Danish: CD-Studie II: Infliximab erfarne patienter
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Hvis du har yderligere spørgsmål til anvendelsen af dette lægemiddel, skal du spørge din læge eller apotek.
English: If you accidentally inject AMGEVITA more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell him/her that you have taken more.
Danish: Hvis du ved en fejltagelse injicerer AMGEVITA hyppigere end forskrevet af lægen eller apoteket, kontakt lægen eller apoteket og fortæl ham/hende, at du har taget mere.
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see table 10).
Danish: I RA-studie V blev strukturel ledskade vurderet radiografisk og udtrykt som ændringer i modificeret Total Sharp Score (se tabel 10).
English: Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity.
Danish: De prækliniske data viser ingen særlig fare for mennesker på basis af studie af toksicitet efter enkeltdosering, gentagen dosistoksicitet og genotoksicitet.
English: • hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
Danish: • hepatosplenisk T-celle lymfom (en sjælden form for blodkræft, som ofte er dødelig),
English: Important: You must push all the way down but do not touch the blue start button until you are ready to inject.
Danish: Vigtigt: Du skal trykke pennen helt ned, men må ikke røre ved den blå startknap, før du er klar til at injicere.
English: Before initiation of therapy with AMGEVITA, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Danish: Før behandling med AMGEVITA påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkulose.
English: Of the 371 remaining patients, 276 evaluable patients reached 78 weeks of open-label adalimumab treatment.
Danish: Ud af de 371 resterende patienter opnåede 276 egnede patienter 78 uger med åben adalimumabbehandling.
English: • allergic reactions (including seasonal allergy);
Danish: • allergiske reaktioner (inklusive sæsonbestemt allergi),
English: • You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last AMGEVITA treatment.
Danish: • Du bør overveje brugen af passende prævention for at forhindre graviditet og fortsætte brugen mindst 5 måneder efter den sidste behandling med AMGEVITA.
English: Radiographic mean changes at week 52 in RA study V
Danish: Gennemsnitlige radiografiske ændringer i uge 52 i RA-studie V
English: It is normal to see a drop of liquid at the end of the needle.
Danish: Det er normalt, at man kan se en dråbe medicin i enden af kanylen.
English: Multiple sclerosis,
Danish: Multipel sklerose,
English: Clean your injection site with an alcohol wipe.
Danish: Rens injektionsstedet med en alkoholvædet serviet.
English: If you have or develop demyelinating disease such as multiple sclerosis, your doctor will decide if you should receive or continue to receive AMGEVITA.
Danish: - Hvis du har eller udvikler demyeliniserende sygdom som dissemineret sklerose vil din læge afgøre om du skal have eller fortsætte med at få AMGEVITA.
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 standard-dosis-vedligeholdelsesregime som vist i tabel 25.
English: NA 24.0% 58.9%
Danish: NA NA NA 24,0 % 58,9 %
English: Clinical response is usually achieved within 2-8 weeks of treatment.
Danish: Klinisk respons opnås normalt inden for 2-8 ugers behandling.
English: Patients should be tested for HBV infection before initiating treatment with AMGEVITA.
Danish: Patienter bør testes for HBV-infektion inden behandling med AMGEVITA.
English: AMGEVITA should only be used during pregnancy if clearly needed.
Danish: • AMGEVITA bør kun anvendes under graviditet, hvis det er tydeligvis nødvendigt.