FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are concerned with the appearance of the solution, then contact your pharmacist for assistance.
Danish: Hvis du er bekymret over, hvordan opløsningen ser ud, så kontakt apotekspersonalet for at få hjælp.
English: Figure C: Safety Checks before injection
Danish: Figur C: Sikkerhedstjek før injektion
English: If you have any questions, please talk to a doctor, pharmacist or nurse who is familiar with Hefiya.
Danish: Hvis du har nogen spørgsmål, så tal med en læge, apotekspersonalet eller en sygeplejerske, som kender Hefiya.
English: Patients from studies UC-I and UC-II had the option to roll over into an open-label long-term extension study (UC III).
Danish: Patienter fra studie UC-I og UC-II havde mulighed for at indgå i et åben-label langvarigt forlængelsesstudie (UC III).
English: After 32 weeks or at disease flare, patients were eligible to enrol into the open label extension phase (table 12).
Danish: Efter 32 uger eller ved opblussen af sygdommen var patienterne egnede til inklusion i den åbne forlængelsesfase (tabel 12).
English: Clinical remission results remained relatively constant irrespective of previous TNF-antagonist exposure.
Danish: Raterne for klinisk remission forblev forholdsvis konstante uanset tidligere TNF-antagonisteksponering.
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: Monoclonal antibodies are proteins that attach to a specific target in the body.
Danish: Monoklonale antistoffer er proteiner, som binder til et bestemt mål i kroppen.
English: Do not use if any particulates and / or discolorations are observed.
Danish: Brug den ikke, hvis du ser partikler og/eller misfarvning.
English: The long half-life of adalimumab should be taken into consideration if a surgical procedure is planned.
Danish: Den lange halveringstid for adalimumab bør tages med i overvejelserne, når der planlægges kirurgisk indgreb.
English: Maintenance of remission and response rates are presented in table 24.
Danish: Rater for vedligeholdelse af remissions- og responsrater er vist i tabel 24.
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: Patients taking TNF-antagonists are more susceptible to serious infections.
Danish: Patienter, som tager TNF-antagonister, er mere modtagelige over for alvorlige infektioner.
English: Treatment
Danish: Behandling
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet efter faldende alvorlighed.
English: Patient weight
Danish: Patientvægt
English: Detailed instructions on how to inject Hefiya are provided in section 7, “Instructions for use”.
Danish: Detaljeret vejledning om, hvordan Hefiya injiceres, gives i punkt 7 ”Brugsvejledning”.
English: • Tell your doctor if you have lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common.
Danish: • Fortæl din læge, hvis du har haft fast bopæl eller rejst i områder, hvor svampeinfektioner som histoplasmose, kokcidioidomyse eller blastomykose er almindelige.
English: Adalimumab was studied in 9,506 patients in pivotal controlled and open label trials for up to 60 months or more.
Danish: Adalimumab blev undersøgt hos 9.506 patienter i pivotale kontrollerede og åbne studier i op til 60 måneder eller mere.
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 store your pen in extreme heat or cold.
Danish: • Opbevar ikke din pen i ekstrem varme eller kulde.
English: The conduct and results of these tests should be recorded on your Patient Reminder Card.
Danish: Disse undersøgelser og resultaterne heraf bør registreres på dit patientkort.
English: This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Danish: Denne sjældne type af T-cellelymfom har et meget aggressivt sygdomsforløb og er sædvanligvis letal.
English: Do not re-use the pen.
Danish: Brug ikke pennen igen.
English: Table 25 maintenance regimen patient weight low dose standard dose
Danish: Tabel 25 Vedligeholdelsesregime patient vægt lavdosis standarddosis
English: Treatment with adalimumab 40 mg every week significantly reduced the risk of worsening of abscesses and draining fistulas.
Danish: Behandling med 40 mg adalimumab hver uge reducerede risikoen for forværring af abscesser og suppurerende fistler signifikant.
English: Your doctor should test you for HBV. Adalimumab can reactivate HBV infection in people who carry this virus.
Danish: Lægen vil teste dig for HBV. Adalimumab kan reaktivere HBV-infektion hos mennesker, der bærer denne virus.
English: NE = not estimable.
Danish: NE = ikke estimerbar.
English: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 nM).
Danish: Adalimumab modulerer også de biologiske responser, som induceres eller reguleres af TNF, herunder ændringer i niveauerne af de adhæsionsmolekyler, som er ansvarlige for leukocytmigrationen (ELAM-1, VCAM-1 og ICAM-1 med en IC50 på 0,1-0,2 nM).
English: If you have Crohn's disease you will first be given other medicines.
Danish: Hvis du har Crohns sygdom, vil du først få anden medicin.
English: • high blood sugar;
Danish: • højt blodsukker
English: In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients.
Danish: Generelt var bivirkningerne i hyppighed og type hos pædiatriske patienter tilsvarende dem, som blev set hos voksne patienter.
English: 8 to 12 years
Danish: 8-12 år
English: 30 months
Danish: 30 måneder
English: • swollen face, hands, feet;
Danish: • hævelser i ansigt, hænder eller fødder
English: It may harm them, even if their signs of illness are the same as yours.
Danish: Symptomerne kan være ømme knuder i huden (noduli) og abscesser (bylder), som kan udtømme pus.
English: Available data suggest that re-introduction of adalimumab after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Danish: Tilgængelige data tyder på, at genopstart af adalimumab efter doseringsindstilling i 70 dage eller længere resulterede i et klinisk respons i samme størrelsesorden og med samme sikkerhedsprofil som før behandlingsafbrydelsen.
English: Cancer
Danish: Kræft
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: o In this configuration the needle guard is
Danish: o I denne konfiguration er kanylebeskyttelsen
English: • Push the needle all the way in to ensure that the medication can be fully administered
Danish: • Pres kanylen helt ind for at sikre, at lægemidlet kommer fuldstændigt ind.
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 samtidig behandling med methotrexat.
English: double-blind response at week 68
Danish: Dobbeltblindet respons ved uge 68
English: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Hefiya.
Danish: Patienter skal derfor monitoreres nøje for infektioner, herunder tuberkulose, før, under og efter behandling med Hefiya.
English: • As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Hefiya.
Danish: • Eftersom der har været rapporteret tilfælde af tuberkulose hos patienter i behandling med adalimumab, vil lægen undersøge dig for tegn og symptomer på tuberkulose, før behandling med Hefiya påbegyndes.
English: A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded.
Danish: En risiko for udvikling af maligniteter hos børn og unge behandlet med TNF-antagonister kan ikke udelukkes.
English: efficacy outcomes double blind 32 weeks adalimumab / MTX (N =38)
Danish: resultater af effekt dobbeltblindet 32 uger adalimumab/ MTX (N = 38)
English: Reduction in HS-related skin pain was assessed using a Numeric Rating Scale in patients who entered the study with an initial baseline score of 3 or greater on a 11 point scale.
Danish: Reduktion i HS-relateret hudsmerte blev evalueret ved hjælp af en numerisk vurderingsskala hos patienter, som gik ind i studiet med startbaseline score på 3 eller højere på en skala med 11 trin.
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: Hefiya works by reducing this inflammation.
Danish: Hefiya virker ved at reducere denne inflammation.
English: • blood in urine;
Danish: • blod i urinen
English: These infections have not consistently been recognised in patients taking TNF-antagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
Danish: Disse infektioner er ikke konsekvent blevet erkendt hos patienter, som tager TNF-antagonister, hvorved iværksættelse af passende behandling er blevet forsinket, hvilket sommetider har resulteret i letale udfald.
English: Among the 250 subjects who completed the open-label extension study, improvements in physical function were maintained through 10 years of treatment.
Danish: Ud af 250 patienter som afsluttede det åbne forlængelsesstudie blev forbedring af fysisk funktion opretholdt gennem 10 års behandling.
English: Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after adalimumab administration.
Danish: Serumniveauer af matrixmetalloproteinaser (MMP-1 og MMP-3), som forårsager vævsomdannelse, der er ansvarlig for bruskdestruktionen, var også nedsatte efter adalimumab-administration.
English: Hefiya is used to treat
Danish: Hefiya bruges til at behandle
English: • Do not store the syringes in extreme heat or cold.
Danish: • Opbevar ikke sprøjterne i ekstrem varme eller kulde.
English: 4 to 7 years
Danish: 4-7 år
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 forandrer sig, skal du fortælle det til din læge.
English: The efficacy of adalimumab in those patients was reduced compared to that in anti-TNF naïve patients.
Danish: Effekten af adalimumab var nedsat hos disse patienter sammenlignet med anti-TNF-naive patienter.
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: Some of those patients were also treated with the medicines azathioprine or mercaptopurine.
Danish: Nogle af disse patienter blev også behandlet med lægemidlerne azathioprin eller mercaptopurin.
English: Due to its inhibition of TNFα, adalimumab administered during pregnancy could affect normal immune responses in the newborn.
Danish: På grund af sin TNFα-hæmmende virkning kan adalimumab administreret under graviditet påvirke de normale immunresponser hos nyfødte.
English: In a developmental toxicity study conducted in monkeys, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
Danish: I et toksicitetsstudie, 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: Throughout all 3 studies patients used topical antiseptic wash daily.
Danish: Gennem alle 3 studier brugte patienterne topikal antiseptisk vask dagligt.
English: No dose-limiting toxicity was observed during clinical trials.
Danish: Der blev ikke observeret nogen dosisbegrænsende toksicitet i kliniske studier.
English: • that Hefiya treatment may increase the potential risks of o infections, including tuberculosis o cancer o nervous system problems o vaccinations
Danish: • at behandling med Hefiya kan øge de mulige risici for o infektioner, inklusive tuberkulose o cancer o problemer med nervesystemet o vaccinationer
English: Most ALT elevations occurred with concomitant methotrexate use.
Danish: Størstedelen af ALAT-stigningerne forekom ved samtidig brug af methotrexat.
English: These patients also had objective evidence of inflammation in the sacroiliac joints or spine on MRI or elevated hs-CRP.
Danish: Disse patienter havde også objektive tegn på inflammation i sakroiliakaleddene eller rygsøjlen ved MRI eller forhøjet hs-CRP.
English: After proper training in injection technique, patients may self-inject with Hefiya 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 Hefiya, såfremt lægen finder det hensigtsmæssigt, og med nødvendig lægelig opfølgning.
English: • neurological infections (including viral meningitis);
Danish: • neurologiske infektioner (inklusive viral meningitis)
English: Patients were permitted to be either disease-modifying, antirheumatic drug-naïve or to remain on their pre-existing rheumatologic therapy provided that therapy was stable for a minimum of 28 days.
Danish: Det var tilladt for patienterne at være enten fri for sygdomsmodificerende antireumatisk lægemiddel eller at forblive i deres allerede eksisterende reumatologiske terapi, forudsat at terapien havde været stabil i mindst 28 dage.
English: Table 29 time to treatment failure in studies UV I and UV II
Danish: Tabel 29 Tid til behandlingssvigt i studie UV I og UV II
English: 10 A-6250 Kundl Austria
Danish: 10 A-6250 Kundl Østrig
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: Patients on Hefiya may receive concurrent vaccinations, except for live vaccines.
Danish: Patienter i Hefiya-behandling kan modtage samtidige vaccinationer, undtagen med levende vacciner.
English: Talk to your healthcare provider if you have any questions.
Danish: Tal med din læge, hvis du har nogen spørgsmål.
English: Population pharmacokinetic analyses with data from over 1,300 RA patients revealed a trend toward higher apparent clearance of adalimumab with increasing body weight.
Danish: Farmakokinetiske populationsanalyser med data fra flere end 1.300 RA-patienter viste en tendens til en tilsyneladende højere clearance af adalimumab med stigende legemsvægt.
English: Hefiya should be used with caution in patients with mild heart failure (NYHA class I/II).
Danish: Hefiya bør anvendes med forsigtighed til patienter med let hjerteinsufficiens (NYHA, klasse I/II).
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: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Danish: Under vedligeholdelsesbehandling kan kortikosteroider nedtrappes i overensstemmelse med retningslinjer for klinisk praksis.
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 Hefiya and during treatment with Hefiya.
Danish: - Din læge vil også udlevere et patientkort, der indeholder vigtige sikkerhedsinformationer, som du skal være opmærksom på før og under din behandling med Hefiya.
English: ACR responses were maintained in the open-label extension study for up to 136 weeks.
Danish: ACR-respons blev opretholdt i det åbne forlængelsesstudie i op til 136 uger.
English: Across all indications in clinical trials patients with raised ALT were asymptomatic and in most cases elevations were transient and resolved on continued treatment.
Danish: I kliniske studier på tværs af alle indikationer var patienter med forhøjet ALAT asymptomatiske, og i de fleste tilfælde var forhøjelsen forbigående og forsvandt ved fortsat behandling.
English: Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
Danish: Adalimumab er et rekombinant humant monoklonalt antistof fremstillet i ovarieceller fra kinesiske hamstre.
English: Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra studier af toksicitet efter enkeltdosering, toksicitet efter gentagne doser og genotoksicitet.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: • Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and blistering rash);
Danish: • Stevens-Johnsons syndrom (livstruende reaktion med influenza-lignende symptomer og udslæt med blærer)
English: After adjustment for weight differences, gender and age appeared to have a minimal effect on adalimumab clearance.
Danish: Efter justering for vægtforskelle viste køn og alder sig kun at have minimal effekt på clearance af adalimumab.
English: There is limited experience in the initiation of treatment with adalimumab alone.
Danish: Der er begrænset erfaring med initiering af behandling med adalimumab alene.
English: Therapy continued beyond 12 weeks did not result in significantly more responses (see section 4.2).
Danish: Behandling efter uge 12 resulterede ikke i signifikant flere respondere (se pkt.
English: During the study, most subjects used concomitant MTX, with fewer reporting use of corticosteroids or NSAIDs.
Danish: I løbet af studiet fik de fleste patienter samtidig MTX, og et mindre antal rapporterede brug af kortikosteroider eller NSAIDs.
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: • Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses and should not be given during treatment with Hefiya in case they cause infections.
Danish: • Visse vacciner indeholder levende men svækkede former for sygdomsfremkaldende bakterier eller virusser og bør ikke gives under Hefiya-behandling i tilfælde af, at de giver infektioner.
English: Blood and the lymphatic system disorders*
Danish: Blod og lymfesystem*
English: o The syringe is ready for use (see Figure C).
Danish: o Sprøjten er klar til brug (se Figur C).
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: A large number (approximately 2100) of prospectively collected pregnancies exposed to adalimumab resulting in live birth with known outcomes, including more than 1500 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Danish: Prospektivt indsamlede data for et stort antal (cirka 2.100) graviditeter med eksponering for adalimumab, som resulterede i levende fødte med kendt graviditetsudfald, inklusive mere end 1.500 eksponeringer i det første trimester, indikerer ikke stigning i hyppighed af misdannelser hos nyfødte.
English: Patients who achieved PASI 75 and PGA clear or minimal were withdrawn from treatment for up to 36 weeks and monitored for loss of disease control (i.e. a worsening of PGA by at least 2 grades).
Danish: Patienter, som opnåede PASI 75og PGA clear eller minimal, blev taget ud af behandling i op til 36 uger og monitoreret for tab af sygdomskontrol (dvs. forværring af PGA med mindst 2 enheder).
English: week 26 week 52 p value for standard dose versus low dose comparison.
Danish: uge 26 uge 52, 1 p-værdi for sammenligning af standarddosis versus lavdosis.
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 standarddosis-vedligeholdelsesregime som vist i tabel 25.
English: By attaching to TNFα, Hefiya blocks its action and reduces the inflammation in these diseases.
Danish: Ved at binde sig til TNFα blokerer Hefiya dennes virkning og reducerer den inflammatoriske proces i disse sygdomme.
English: No patients developed lupus nephritis or central nervous system symptoms.
Danish: Ingen patienter udviklede lupus nefrit eller symptomer i centralnervesystemet.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Danish: Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer)
English: The following side effects have been observed with adalimumab:
Danish: Følgende bivirkninger er observeret ved brug af adalimumab:
English: primary analysis (ITT) placebo adalimumab
Danish: primær analyse (ITT) placebo adalimumab
English: If you take Hefiya the risk of getting lymphoma, leukaemia, or other cancers may increase.
Danish: Når du tager Hefiya, kan risikoen for at få et lymfom, leukæmi eller andre former for kræft øges.
English: No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab.
Danish: Der er ingen tilgængelige data vedrørende den sekundære overførsel af infektion med levende vacciner hos patienter, der modtager adalimumab.
English: The pre-filled syringe / pre-filled pen must be protected from light, and discarded if not used within the 14-day period.
Danish: Den fyldte injektionssprøjte/fyldte pen skal beskyttes mod lys og kasseres, hvis den ikke anvendes inden for 14-dages perioden.
English: Hidradenitis suppurativa (HS)
Danish: Hidrosadenitis suppurativa (HS)
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 adalimumab-behandling.
English: 20 weeks
Danish: 20 uger
English: Among those, 109 subjects (63.7 %) were reported to be in remission at 10 years.
Danish: Ud af disse var 109 patienter (63,7 %) i remission efter 10 år.