FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who experience insufficient response may benefit from an increase in dosage:
Danish: Patienter, som oplever utilstrækkeligt respons, kan have fordel af at øge dosis til:
English: In RA study III, these improvements were maintained throughout 52 weeks.
Danish: I RA-studie III holdt disse forbedringer sig i 52 uger.
English: Succursale de Corsier-sur-Vevey Chemin du Fenil Zone Industrielle B 1804 Corsier-sur-Vevey Switzerland
Danish: Succursale de Corsier-sur-Vevey Chemin du Fenil Zone Industrielle B 1804 Corsier-sur-Vevey Schweiz
English: Kromeya is available in other presentations.
Danish: Kromeya er tilgængelig i andre præsentationer.
English: Tell your doctor as soon as possible, if you notice any of the following:
Danish: Kontakt lægen så hurtigt som muligt, hvis du oplever noget af følgende:
English: Slowly release your thumb up.
Danish: Giv langsomt slip med tommelfingeren.
English: In rare cases, these infections may be lifethreatening.
Danish: I sjældne tilfælde kan disse infektioner være livstruende.
English: Patient weight
Danish: Patient vægt
English: Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests.
Danish: Nogle bivirkninger, som er set med adalimumab, har ikke symptomer og kan kun opdages ved blodprøver.
English: However, please note that Kromeya is neither intended nor authorized for treatment of hidradenitis suppurativa.
Danish: Bemærk dog, at Kromeya ikke er beregnet eller godkendt til behandling af hidrosadenitis suppurativa.
English: Seek medical attention urgently, if you notice any of the following signs of allergic reaction or heart failure:
Danish: Søg straks lægehjælp, hvis du får følgende tegn på en allergisk reaktion eller hjertesvigt:
English: PGA-F clear/minimal and ≥2-grade improvement (%)
Danish: PGA-F clear/minimal og ≥2-grade forbedring (%)
English: 1.4 You will also need following supplies that are not included in the kit:
Danish: 1.4 Du skal også bruge følgende, som ikke indgår i sættet:
English: Side effects may occur up to 4 months or more after the last Kromeya injection.
Danish: Bivirkninger kan forekomme op til 4 måneder eller mere efter den sidste Kromeya injektion.
English: • When the syringe plunger has moved to the bottom and has stopped moving, continue holding it for 5 seconds.
Danish: • Når sprøjtestemplet er kommet helt i bund og ikke længere bevæger sig, skal det holdes nede i 5 sekunder.
English: Double-blind response at week 68
Danish: Dobbelt-blind respons ved uge 68
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: Your child may first be given other medicines.
Danish: Dit barn kan få anden medicin først.
English: Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80% of patients continued to receive at least one of these medications.
Danish: Samtidige faste doser af aminosalicylater, kortikosteroider, og/eller immunmodulerende midler var tilladt, og 80 % af patienterne fortsatte med at få mindst et af disse lægemidler.
English: Detailed instructions on how to inject Kromeya are provided in section 7 ‘Instructions for use'.
Danish: Detaljeret vejledning om, hvordan Kromeya injiceres, gives i punkt 7 ”Brugsvejledning”.
English: Double-blind response at week 12
Danish: Dobbelt-blind respons ved uge 12
English: • Hold the syringe like a pencil.
Danish: • Hold injektionssprøjten som en blyant.
English: The primary endpoint was ‘time to treatment failure'.
Danish: Det primære endpepunkt var ”tid til behandlingssvigt”.
English: Kromeya may be available in other presentations depending on the individual treatment needs.
Danish: Kromeya er tilgængelig i andre præsentationer afhængigt af individuelt behandlingsbehov.
English: You should continue to inject Kromeya for as long as your doctor has told you.
Danish: Du skal fortsætte med at injicere Kromeya i så lang tid, som din læge har fortalt dig.
English: According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.
Danish: Der var i følge et graviditetsstudie ikke højere risiko for misdannelser, når moderen havde fået adalimumab under graviditeten, ved sammenligning med mødre med samme sygdom, som ikke havde fået adalimumab.
English: • place two fingers on the label area
Danish: • tag fat om pennen med to fingre ved etiketområdet
English: 2-sided p value from log rank test.
Danish: 2-sidet p-værdi fra log rank test.
English: Ped ACR 30 response (n/N)
Danish: Pædiatrisk ACR 30respons (n/N)
English: • On rare occasions, treatment with Kromeya could result in lupus-like syndrome.
Danish: • I sjældne tilfælde kan behandling med Kromeya resultere i lupus-lignende syndrom.
English: Without MTX
Danish: Uden MTX
English: Your doctor may prescribe another strength of Kromeya if your child needs a different dose.
Danish: Din læge kan ordinere en anden styrke af Kromeya, hvis dit barn behøver en anderledes dosis.
English: Not all presentations may be marketed.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg subcutaneous dose was 64%.
Danish: Den gennemsnitlige absolutte biotilgængelighed af adalimumab, estimeret ud fra tre studier efter en enkelt 40 mg subkutan dosis, var 64%.
English: 117/276 patients from CD study I and 272/777 patients from CD studies II and III were followed through at least 3 years of open-label adalimumab therapy.
Danish: 117/276 patienter fra CD-studie I og 272/777 patienter fra CD-studie II og III blev fulgt gennem mindst 3 års åben-label adalimumab-behandling.
English: Drop outs due to reasons other than treatment failure were censored at the time of dropping out.
Danish: Frafald, som skyldtes andet end behandlingssvigt, blev censoreret på tidspunktet for frafald.
English: The liquid should be clear and colorless.
Danish: Væsken skal være klar og farveløs.
English: Transparent syringe housing Figure H
Danish: Gennemsigtigt sprøjtehus Figur H
English: TNF-antagonists, such as adalimumab affect the immune system and their use may affect the body's defence against infection and cancer.
Danish: TNF-antagonister, så som adalimumab påvirker immunsystemet og brugen af dem kan påvirke kroppens forsvar mod infektion og cancer.
English: Clinical studies in patients suffering hidradenitis suppurativa in this section are merely included for public health reasons.
Danish: Kliniske studier i dette afsnit vedrørende patienter, som lider af hidrosadenitis suppurativa, er kun inkluderet af sundhedsmæssige årsager.
English: Clinical response (CR- 100)
Danish: Klinisk respons (CR-100)
English: If you still see air gaps or bubbles at the tip of the syringe, repeat this step until air gaps or bubbles are gone.
Danish: Hvis du stadig kan se luftbobler ved sprøjtespidsen, skal du gentage disse trin, indtil boblerne er forsvundet.
English: The recommended doses for Kromeya in each of the approved uses are shown in the following table.
Danish: De anbefalede doser af Kromeya, til hver af de godkendte anvendelser, er vist i følgende tabel:
English: Kromeya is a biosimilar medicinal product.
Danish: Kromeya er et biosimilært lægemiddel.
English: Kromeya should only be used during a pregnancy if needed.
Danish: Kromeya bør kun anvendes under graviditet, hvis det nødvendigt.
English: Week 52 Fistula remission3
Danish: Uge 52 Remission af fistler3
English: Anti-adalimumab antibodies may develop during adalimumab treatment.
Danish: Anti-adalimumab antistoffer kan udvikles i løbet af adalimumab-behandlingen.
English: No effects on the breastfed newborns/infants are anticipated.
Danish: Der forventes ingen effekt hos den/det brysternærede nyfødte/spædbarn.
English: Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1% to 1% of the maternal serum level.
Danish: Begrænset information i offentliggjort litteratur indikerer, at adalimumab udskilles i brystmælk i meget lave koncentrationer med en tilstedeværelse af adalimumab i human brystmælk i koncentrationer på 0,1 % til 1 % af det maternale serumniveau.
English: Deafness, tinnitus
Danish: Døvhed, tinnitus
English: CI 95% for HR
Danish: CI 95% for HRa
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: 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: The potential risk with the combination of azathioprine or 6-mercaptopurine and adalimumab should be carefully considered.
Danish: Den potentielle risiko ved kombination af azathioprin eller 6-mercaptopurin med adalimumab bør nøje overvejes.
English: Then release the pinched skin.
Danish: Giv derefter slip på huden.
English: The pen is a single use, disposable, handheld, mechanical injection device.
Danish: Pennen er et engangs, håndholdt, mekanisk injektionsudstyr.
English: TIME (WEEKS)
Danish: TID (UGER)
English: You and your doctor should pay special attention to signs of infection while you are being treated with Kromeya.
Danish: Du og din læge bør være særligt opmærksomme på tegn på infektion, mens du er i behandling med Kromeya.
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: 1.1 Prepare a clean flat surface, such as a table or countertop, in a well-lit area.
Danish: 1.1 Klargør en ren, plan flade, f.eks. på et spisebord eller køkkenbord, i et godt oplyst lokale.
English: Approximately 40% of patients in study UC-II had failed prior anti-TNF treatment with infliximab.
Danish: Omkring 40 % af patienterne i UC-studie II havde tidligere haft mislykket anti-TNF-behandling med infliximab.
English: Kromeya in combination with methotrexate, is indicated for:
Danish: Kromeya i kombination med methotrexat er indiceret til:
English: • A sharps container (see section 7.2).
Danish: • en affaldsbeholder til skarpe genstande (se afsnit 7.2).
English: Therefore, the combination of adalimumab and anakinra is not recommended.
Danish: Samtidig administration af adalimumab og anakinra anbefales derfor ikke.
English: Patients on adalimumab may receive concurrent vaccinations, except for live vaccines.
Danish: Patienter i adalimumab-behandling kan modtage samtidige vaccinationer, undtagen med levende vacciner.
English: Analysis treatment
Danish: Analyse Behandling
English: Warning: Do not use if expiration date has passed.
Danish: Advarsel: Må ikke bruges, hvis udløbsdatoen er overskredet.
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: The highest dose level evaluated has been multiple intravenous doses of 10 mg/kg, which is approximately 15 times the recommended dose.
Danish: Det højeste dosisniveau, som er evalueret, har været adskillige intravenøse doser på 10 mg/kg, hvilket er næsten 15 gange den anbefalede dosis.
English: Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD study I (CLASSIC I) and CD study II (GAIN).
Danish: Induktion af klinisk remission (defineret som CDAI < 150) blev undersøgt i to studier, CD-studie I (CLASSIC I) og CD-studie II (GAIN).
English: Clinical remission results remained relatively constant irrespective of previous TNF-antagonist exposure.
Danish: Raterne for klinisk remission forblev forholdvis konstante uanset tidligere TNF-antagonisteksposition.
English: This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Danish: Denne sjældne type af T-celle lymfom har et meget aggressivt sygdomsforløb og er sædvanligvis letal.
English: 1.3 Open the kit and take out all components and put them on a clean, dry, flat surface.
Danish: 1.3 Åbn sættet, tag alle delene ud og anbring dem på en ren, tør og plan flade.
English: ACR responses in PsA study I were similar with and without concomitant methotrexate therapy.
Danish: ACR-respons i PsA-studie I var det samme med og uden methotrexat.
English: If retreatment with Kromeya is indicated, the above guidance on dose and treatment duration should be followed.
Danish: Hvis genbehandling med Kromeya er indiceret, bør ovenstående vejledning for dosering og behandligsvarighed følges.
English: Travel/recurrent infection
Danish: Rejse/gentagne infektioner
English: NA 9.5% 41.5%
Danish: NA NA 9,5% 41,5%
English: Warning: Do not use the pre-filled pen if the name on the label is not Kromeya and/or the expiration date on the label has passed.
Danish: Advarsel: Du må ikke bruge den fyldte pen, hvis der ikke står Kromeya på etiketten, og/eller hvis udløbsdatoen på etiketten er overskredet.
English: Patients taking TNF-antagonists are more susceptible to serious infections.
Danish: Patienter, som tager TNF-antagonister, er mere modtagelige for alvorlige infektioner.
English: Warning: Do not keep any unused medicine.
Danish: Advarsel: Du må ikke gemme eventuel ikke-anvendt medicin.
English: The primary efficacy endpoint in both studies was ´time to treatment failure´.
Danish: Det primære effektmål i begge studier var tid til behandlingssvigt.
English: Population pharmacokinetic analyses with data from over 1300 RA patients revealed a trend toward higher apparent clearance of adalimumab with increasing body weight.
Danish: Farmakokinetiske populationsanalyser med data fra flere end 1300 RA patienter viste en tendens til en tilsyneladende højere clearance af adalimumab med stigende legemsvægt.
English: Vertigo and visual impairment may occur following administration of Kromeya (see section 4.8).
Danish: Vertigo og svækket syn kan forekomme efter administration af Kromeya (se pkt 4.8).
English: • If you are over 65 years you may be more susceptible to infections while taking Kromeya.
Danish: • Hvis du er over 65 år, kan du være mere modtagelig for infektioner, mens du tager Kromeya.
English: 1.5 Take a pre-filled pen out of the original box:
Danish: 1.5 Tag en fyldt pen ud af den originale æske:
English: If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your doctor.
Danish: Hvis der kommer nye områder med beskadiget hud under eller efter behandlingen, eller hvis de nuværende beskadigede områder forandre sig, skal du fortælle det til din læge.
English: No dose-limiting toxicity was observed during clinical trials.
Danish: Der blev ikke observeret nogen dosisbegrænsende toksicitet i kliniske undersøgelser.
English: Check with your child's doctor or pharmacist if you are not sure about any of the instructions or if you have any questions.
Danish: Spørg dit barns læge eller apotekspersonalet, hvis du er usikker på nogen af instruktionerne eller hvis du har spørgsmål.
English: Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at week 8.
Danish: Klinisk remission (defineret som Mayo-score < 2 med ingen subscore > 1) blev vurderet i uge 8.
English: Kromeya should be used with caution in patients with mild heart failure (NYHA class I/II).
Danish: Kromeya bør anvendes med forsigtighed til patienter med let hjerteinsufficiens (NYHA, klasse I/II).
English: Take a syringe out of the original box:
Danish: Tag en injektionssprøjte ud af den originale æske:
English: 7.1 Now that you have completed your injection, update your record with:
Danish: 7.1 Nu hvor du har indgivet injektionen, skal du registrere følgende:
English: Disease flare criteria were defined as a worsening of ≥ 30% from baseline in ≥ 3 of 6 Pediatric 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: Injecting cold medicine may be painful.
Danish: Det kan gøre ondt at injicere kold medicin.
English: Of those in clinical response at week 4, 48% had been previously exposed to other TNF-antagonists.
Danish: Blandt patienter med klinisk respons i uge 4 havde 48% tidligere været eksponeret for anden TNF-antagonist.
English: In a developmental toxicity study conducted in monkeys, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
Danish: I et toksicitetstudie, hvor man undersøgte udviklinger på aber, var der ingen tegn på maternel toksicitet, embryotoksicitet eller teratogenicitet.
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,d,e
Danish: ASDASc,d,e
English: confidence interval)
Danish: konfidensintervalb)
English: • an alcohol pad (included in the box)
Danish: • en spritserviet (vedlagt i æsken)
English: ASASa,b 20 ASAS
Danish: ASASa,b 20
English: Due to its inhibition of TNFα, adalimumab administered during pregnancy could affect normal immune responses in the newborn.
Danish: På grund af sin TNF-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 Kromeya.
Danish: Patienter skal derfor monitoreres nøje for infektioner, herunder tuberkulose, før, under og efter behandling med Kromeya.
English: Kromeya is intended for the treatment of the following inflammatory diseases:
Danish: Kromeya er beregnet til behandlingen af følgende inflammatoriske sygdomme:
English: Treatment with Kromeya may result in the formation of autoimmune antibodies.
Danish: Behandling med Kromeya kan medføre dannelse af autoimmune antistoffer.
English: Week 26 placebo-controlled
Danish: Uge 26 Placebokontrolleret
English: • Do not use the 40 mg pre-filled syringe or 40 mg pre-filled pen if doses other than 40 mg are recommended.
Danish: • Brug ikke 40 mg fyldt injektionssprøjte eller 40 mg fyldt pen, hvis det anbefales at bruge andre doser end 40 mg.
English: In CD study III, at week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis.
Danish: I CD-studie III havde 58% (499/854) af patienterne klinisk respons i uge 4 og blev vurderet i den primære analyse.
English: • Do not insert your fingers into the opening of the safety guard.
Danish: • Du må ikke føre dine fingre ind i sikkerhedsmekanismens åbning.
English: In all situations described below, the benefit/risk balance of therapy should be very carefully considered.
Danish: I alle situationer beskrevet nedenfor skal balancen mellem fordele/ulemper ved behandling tages meget nøje i betragtning.
English: • Give plunger a final push to ensure the full dose has been injected (Figure R).
Danish: • Giv stemplet et sidste tryk for at sikre, at hele dosen er injiceret (figur R).
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: Week 16 placebo-controlled
Danish: Uge 16 Placebokontrolleret
English: The safety guard will slide down and lock into place to protect you from the needle (Figure Q).
Danish: Sikkerhedsmekanismen vil glide ned og klikke på plads for at beskytte dig mod kanylen (figur Q).
English: Kromeya works by reducing this inflammation.
Danish: Kromeya virker ved at reducere denne inflammation.
English: Injecting cold medicine can be painful (Figure E).
Danish: Det kan gøre ondt at injicere kold medicin (figur E).
English: After proper training in injection technique, patients may self-inject with Kromeya 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 Kromeya, såfremt lægen finder det hensigtsmæssigt, og med nødvendig lægelig opfølgning.
English: 2.3 Check the liquid to make sure that : The liquid is clear, colorless, and free of particles.
Danish: 2.3 Tjek væsken for at sikre dig, at: Væsken er klar, farveløs og fri for partikler.
English: • Hold the -pre-filled pen so that you can see the transparent syringe housing.
Danish: • Hold den fyldte pen, så du kan se den gennemsigtige sprøjtehus.
English: By attaching to TNFα, Kromeya blocks its action and reduces the inflammation in these diseases.
Danish: Ved at binde sig til TNF blokerer Kromeya dets virkning og reducerer inflammationen ved disse sygdomme.
English: It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Kromeya.
Danish: Det anbefales, at børn såvidt som muligt får alle de planlagte vaccinationer for deres alder, før behandlingen med Kromeya indledes.
English: It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1).
Danish: Det anbefales, at fordelen og risikoen ved fortsat langvarig behandling vurderes årligt (se pkt.
English: • worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness).
Danish: • forværring af en tilstand, som kaldes dermatomyositis (ses som hududslæt ledsaget af muskelsvaghed)
English: Clinical remission is Mayo score ≤ 2 with no subscore > 1;
Danish: Klinisk remission er Mayo-score < uden subscore >1;
English: In study UV II, statistically significant differences were observed for visual acuity only, but the other components were numerically in favour of adalimumab.
Danish: I studie UV II blev en statistisk signifikant forskel kun set for synsstyrke-komponenten, men de andre komponenter var numerisk til fordel for adalimumab.
English: • With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (Figure P).
Danish: • Med en hurtig, kort bevægelse skal du føre kanylen helt ind i huden i en vinkel på mellem 45° og 90° (figur P).
English: 8.1 To help you remember when and where to do your next injection, you should keep a record of the dates and injection sites used for your injections (Figure V).
Danish: 8.1 For at hjælpe dig med at huske, hvor og hvornår du skal injicere, skal du registrere datoerne og de injektionssteder, du har benyttet til dine injektioner (figur V).