FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has deferred the obligation to submit the results of the studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med referencelægemidlet, der indeholder adalimumab, i en eller flere undergrupper af den pædiatriske population med colitis ulcerosa (se pkt.
English: ACR response
Danish: ACR-respons
English: Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
Danish: Ikke-infektiøs uveitis er en betændelseslignende (inflammatorisk) sygdom, som påvirker bestemte dele af øjet.
English: Healthcare professionals are asked to report any suspected adverse reactions.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger.
English: Cholecystitis and cholelithiasis, hepatic steatosis, bilirubin increased
Danish: Ikke almindelig Kolecystit og cholelithiasis, hepatisk steatose, forhøjet bilirubin
English: 14 weeks a ped ACR 30/50/70 responses week 48 significantly greater than those of placebo-treated patients b p = 0.015
Danish: Pædiatrisk ACR 30/50/70-responser ved uge 48 er signifikant bedre end responserne for placebo- behandlede patienter b p = 0,015
English: Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with adalimumab.
Danish: Hos nogle patienter, som er behandlet tilfredsstillende for aktiv tuberkulose, er aktiv tuberkulose reaktiveret, mens de har været i behandling med adalimumab.
English: Note: P# = Placebo (Number of Events/Number at Risk); A# = Adalimumab (Number of Events/Number at Risk).
Danish: Note: P# = Placebo (antal af hændelser/antal med risiko); A# = Adalimumab (antal af hændelser/antal med risiko).
English: Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96 % of those in serum.
Danish: Koncentrationen af adalimumab i synovialvæsken fra adskillige reumatoid artritpatienter målt i serum var 31-96%.
English: In Study UV I statistically significant differences in favour of adalimumab versus placebo were observed for each component of treatment failure.
Danish: I studie UV I blev en statistisk signifikant forskel til fordel for adalimumab versus placebo observeret for alle komponenter for behandlingssvigt.
English: Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
Danish: Der blev observeret et lignede antistof respons på den 23-valente standard pneumokok-vaccine og den trivalente influenzavirusvaccine i et studie med 226 voksne individer med reumatoid artrit, som blev behandlet med adalimumab eller placebo.
English: Plaque psoriasis is an inflammatory skin condition that causes red, flaky, crusty patches of skin covered with silvery scales.
Danish: Plaque-psoriasis er en inflammatorisk hudlidelse, som forårsager røde, skællende, skorpede pletter på huden dækket med sølvfarvede skæl.
English: Reduction of inflammatory lesions and prevention of worsening of abscesses and draining fistulas was assessed using Hidradenitis Suppurativa Clinical Response (HiSCR; at least a 50 % reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to Baseline).
Danish: Reduktion af inflammatoriske læsioner og forebyggelse af forværring af abscesser og suppurerende fistler blev evalueret ved hjælp af ”Hidradenitis Suppurativa Clinical Response” (HiSCR; mindst 50 % reduktion i det totale antal abscesser og inflammatoriske noduli og uden stigning i antallet af abscesser og suppurerende fistler i forhold til baseline).
English: It is important that you tell your baby's doctors and other health care professionals about your Hefiya 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 Hefiya under graviditeten, så de kan beslutte, hvornår dit spædbarn bør vaccineres.
English: These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome.
Danish: Disse omfatter sjældne rapporter om pancytopeni, aplastisk anæmi, centrale og perifere demyeliniseringsforstyrrelser samt rapporter om lupus, lupus-relaterede tilstande og Stevens-Johnson syndrom.
English: Hefiya is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Danish: Hefiya bruges til at behandle Crohns sygdom hos voksne og børn i alderen 6-17 år.
English: p value*
Danish: p-værdi*
English: Hefiya contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Danish: Hefiya indeholder det aktive stof adalimumab, et lægemiddel, som reagerer på din krops immunforsvar.
English: Psoriasis Study I (REVEAL) evaluated 1,212 patients within three treatment periods.
Danish: I Psoriasis-studie I (REVEAL) blev 1.212 patienter evalueret i tre behandlingsperioder.
English: Patients who were in the non-MTX stratum were either naïve to or had been withdrawn from MTX at least two weeks prior to study drug administration.
Danish: Patienter i stratummet af ikke-MTX-behandlede var enten aldrig blevet behandlet med MTX eller havde fået seponeret MTX mindst to uger før administration af studielægemidlet.
English: You may also use the lower abdomen, but not the area 5 cm around your navel (belly button) (see Figure D).
Danish: Du kan også bruge nederste del af maven men ikke i et område i en omkreds på 5 cm rundt om din navle (se Figur D).
English: Adalimumab significantly decreased the risk of treatment failure by 75% relative to placebo, as shown by the hazard ratio (HR = 0.25 [95% CI: 0.12, 0.49]).
Danish: Adalimumab nedsætter signifikant risikoen for behandlingssvigt med 75 %, som vist med hazard ratio sammenlignet med placebo (HR = 0,25 [95% CI: 0,12; 0,49]).
English: • reactivation of hepatitis B infection;
Danish: • genopblussen af hepatitis B-infektion
English: • reduction in blood platelets which increases risk of bleeding or bruising;
Danish: • nedsat antal blodplader med forøget risiko for blødning eller blå mærker
English: 10 6336 Langkampfen AUSTRIA
Danish: 10 6336 Langkampfen ØSTRIG
English: Table 10 radiographic mean changes at week 52 in RA study V
Danish: Tabel 10 Gennemsnitlige radiografiske ændringer i uge 52 i RA-studie V
English: For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and / or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of Hefiya should be promptly discontinued.
Danish: For patienter, som udvikler tegn og symptomer såsom feber, utilpashed, vægttab, svedeture, hoste, dyspnø, og/eller pulmonale infiltrater eller anden alvorlig systemisk sygdom med eller uden samtidig shock, bør en invasiv svampeinfektion mistænkes, og administration af Hefiya skal omgående afbrydes.
English: Erythema multiforme1), Stevens-Johnson syndrome1), angioedema1), cutaneous vasculitis1) lichenoid skin reaction1)
Danish: Erythema multiforme1), Stevens-Johnsons syndrom1), angioødem1), kutan vaskulitis1), lichenoid hudreaktion1)
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
Danish: • sygdomme i immunsystemet, som kan påvirke lungerne, huden og lymfeknuderne (viser sig oftest som en sygdom, der kaldes sarkoidose)
English: Immunosuppression
Danish: Immunsuppression
English: The active ingredient in Hefiya, adalimumab, is a monoclonal antibody.
Danish: Det aktive stof i Hefiya, adalimumab, er et humant monoklonalt antistof.
English: • non-infectious uveitis.
Danish: • ikke-infektiøs uveitis.
English: Citric acid monohydrate Sodium chloride
Danish: Citronsyremonohydrat Natriumchlorid
English: • do not shake the pen.
Danish: • ikke ryster pennen
English: Rhabdomyolysis, systemic lupus erythematosus
Danish: Ikke almindelig Rabdomyolyse, systemisk lupus erythematosus
English: • Press your pen firmly against the skin to start the injection (see
Danish: • Tryk din pen fast mod huden for at påbegynde injektionen
English: Patients who had been randomised to placebo in period A were assigned to receive placebo in period B.
Danish: Patienter, som var randomiseret til placebo i periode A, blev tildelt placebo i periode B.
English: Patients participating in all Phase 2 and Phase 3 psoriasis studies were eligible to enrol into an openlabel extension trial, where adalimumab was given for at least an additional 108 weeks.
Danish: Patienter, som deltog i alle fase 2 og 3 psoriasis-studier, var egnede til inklusion i et åbent forlængelsesstudie, hvor adalimumab blev givet i mindst 108 uger yderligere.
English: Full instructions for use are provided in the package leaflet.
Danish: Fuld instruktion vedrørende brug findes i indlægssedlen.
English: There is insufficient evidence of the efficacy of adalimumab in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied.
Danish: Der foreligger utilstrækkelig evidens for virkningen af adalimumab hos patienter med ankyloserende spondylitis-lignende psoriasis-artropati, da kun få patienter er blevet undersøgt.
English: The distribution of patients by age and minimum, median and maximum dose received during the OL LI phase is presented in table 11.
Danish: Fordelingen af patienter i henhold til alder samt modtaget minimums-, median- og maksimumsdosis i den åbne indkøringsfase er vist i tabel 11.
English: With the current knowledge, a possible risk for the development of lymphomas, leukaemia, and other malignancies in patients treated with a TNF-antagonist cannot be excluded.
Danish: Med den nuværende viden kan det ikke udelukkes, at der er en mulig risiko for udvikling af lymfomer, leukæmi og andre maligniteter hos patienter, der behandles med TNF-antagonister.
English: Radiographs of hands, wrists, and feet were obtained at baseline and week 24 during the double-blind period when patients were on adalimumab or placebo and at week 48 when all patients were on open-label adalimumab.
Danish: Der blev taget røntgenbilleder af hænder, håndled og fødder ved baseline og uge 24 i den dobbeltblindede periode, hvor patienterne fik adalimumab eller placebo, og ved uge 48, hvor alle patienterne fik åben adalimumab.
English: • Do not freeze your pen.
Danish: • Din pen må ikke fryses.
English: week 52
Danish: uge 52
English: Crohn's disease in adults and children
Danish: Crohns sygdom hos voksne og børn
English: Check the green indicator fills the window (see Figure J):
Danish: Efter din injektion Kontroller, at den grønne indikator fylder vinduet (se Figur J):
English: Do not use this medicine after the expiry date which is stated on the label / blister / carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten/blisterpakningen/pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: You may also use the lower abdomen, but not the area 5 cm around your navel (belly button) (see Figure E).
Danish: Du kan også bruge nederste del af maven, men ikke i et område i en omkreds på 5 cm rundt om din navle (se Figur E).
English: Subjects (n = 215, 54.7 %) who failed to achieve ASAS 20 at weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Danish: Forsøgspersoner (n=215, 54,7 %), som ikke opnåede ASAS 20 ved uge 12, eller 16 eller 20 fik tidligere adgang til åben adalimumab 40 mg subkutant hver anden uge og blev efterfølgende behandlet som non-respondere i de dobbeltblindede statistiske analyser.
English: It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Hefiya.
Danish: Det anbefales, at børn så vidt som muligt får alle vaccinationer i overensstemmelse med gældende retningslinjer for deres alder, før behandlingen med Hefiya indledes.
English: No studies have been conducted that include patients with a history of malignancy or in whom treatment with adalimumab is continued following development of malignancy.
Danish: Der er ikke gennemført nogen studier med patienter, der tidligere har haft maligniteter, hos hvem behandling med adalimumab er fortsat med efterfølgende udvikling af maligniteter.
English: Both studies demonstrated an early and sustained effect of adalimumab on the treatment failure rate versus placebo (see Figure 2).
Danish: Begge studier viste en tidlig og vedvarende effekt af adalimumab på tid til behandlingssvigt versus placebo (se figur 2).
English: Adalimumab / methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and adalimumab monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Danish: Adalimumab/methotrexat-kombinationsterapi var klinisk og statistisk bedre end methotrexat-monoterapi (p<0,001) og adalimumab-monoterapi (p<0,001) i opnåelsen af lav sygdomstilstand hos patienter med nylig diagnosticeret moderat til alvorlig reumatoid artrit.
English: The proportions of subjects with PedACR50 / 70 / 90 at week 12 and week 24 were 90.3 % / 61.3 % / 38.7 % and 83.3 % / 73.3 % / 36.7 %, respectively.
Danish: Forholdet mellem patienter med pædiatrisk ACR-50/70/90 ved uge 12 og uge 24 var henholdsvis 90,3 %/61,3 %/38,7 % og 83,3 %/73,3 %/36,7 %.
English: Asthma, dyspnoea, cough
Danish: Astma, dyspnø, hoste
English: During treatment with Hefiya, other concomitant therapies (e.g., corticosteroids and / or immunomodulatory agents) should be optimised.
Danish: Under behandling med Hefiya bør andre samtidige behandlinger (f.eks. kortikosteroider og/eller immunmodulerende midler) optimeres.
English: Method of administration
Danish: ADMINISTRATIONSMETODE
English: p-value total Sharp score c erosion score JSN
Danish: p-værdi total sharp score
English: TNF-antagonists including adalimumab have been associated in rare instances with new onset or exacerbation of clinical symptoms and / or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.
Danish: TNF-antagonister, herunder adalimumab, er i sjældne tilfælde blevet forbundet med nyt udbrud eller forværring af kliniske symptomer og/eller radiografiske tegn på demyeliniserende sygdom i centralnervesystemet herunder dissemineret sklerose og optisk neurit og perifer demyeliniserende sygdom, inklusive Guillain-Barré syndrom.
English: • In addition cases of non-melanoma skin cancer have been observed in patients taking adalimumab.
Danish: • Derudover er der set tilfælde af ikke-melanom hudkræft hos patienter, der tager adalimumab.
English: In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to congestive heart failure have been observed.
Danish: I et klinisk studie med en anden TNF-antagonist er der observeret forværring af hjerteinsufficiens og forøget mortalitet som følge af hjerteinsufficiens.
English: • If you receive Hefiya during your pregnancy, your baby may have a higher risk for getting an infection.
Danish: • Hvis du får Hefiya, mens du er gravid, kan dit spædbarn have en højere risiko for at få en infektion.
English: Instructions for use
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Hefiya should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en anafylaktisk reaktion eller andre alvorlige allergiske reaktioner, bør behandling med Hefiya straks ophøre, og egnet behandling påbegyndes.
English: Two patients out of 3,441 treated with adalimumab in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
Danish: To patienter ud af 3.441, som blev behandlet med adalimumab i alle reumatoid artrit og psoriasisartrit-studier, udviklede kliniske tegn, der tydede på et nyopstået lupuslignende syndrom.
English: Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with adalimumab, out of which 37 (56.9%) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Danish: Blandt de 68 patienter, som havde opblussen af sygdom i gruppen, som var allokeret til seponering af behandling, fuldførte 65 patienter 12 ugers rescue-behandling med adalimumab, ud af hvilke 37 (56,9 %) genvandt remission (ASDAS < 1,3) 12 uger efter genstart af behandling i den åbne periode.
English: * p < 0.05, *** p < 0.001, adalimumab versus placebo a among all randomised patients.
Danish: * p < 0,05, ***p < 0,001, adalimumab versus placebo a blandt alle randomiserede patienter.
English: • There have been cases of cancers, other than lymphoma, in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFα blocker.
Danish: • Der har været tilfælde af kræft, der er forskellig fra lymfom hos patienter med en specifik lungesygdom kaldet kronisk obstruktiv lungesygdom (KOL), der var i behandling med en anden TNFα-hæmmer.
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTXtreated.
Danish: I den åbne indkøringsfase blev patienterne stratificeret i to grupper - MTX-behandlede (methotrexat-behandlede) og ikke-MTXbehandlede.
English: There is no apparent correlation between the presence of anti-adalimumab antibodies and the occurrence of adverse events.
Danish: Der er ikke nogen tydelig sammenhæng mellem tilstedeværelse af antistoffer og forekomsten af bivirkninger.
English: The efficacy and safety of adalimumab were assessed in five randomised, double-blind and wellcontrolled studies.
Danish: Adalimumabs virkning og bivirkningsprofil blev vurderet i fem randomiserede, dobbeltblindede og velkontrollerede studier.
English: Physicians should exercise caution when considering the use of Hefiya in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Danish: Læger bør være forsigtige, når de overvejer brug af Hefiya til patienter med anamnese af tilbagevendende infektioner eller med øvrige sygdomstilstande, som kan prædisponere patienterne for infektioner, inklusive samtidig anvendelse af immunsuppressive lægemidler.
English: • Slowly release the plunger and allow the needle safety guard to automatically cover the exposed needle (see Figure K).
Danish: • Giv langsomt slip på stemplet, og lad kanylebeskyttelseshylsteret automatisk dække den synlige kanyle (se Figur K).
English: • lupus-like syndrome;
Danish: • lupus-lignende syndrom
English: Reports of serious allergic reactions including anaphylaxis have been received following adalimumab administration.
Danish: Der er modtaget rapporter om alvorlige allergiske reaktioner, inklusive anafylaksi, efter administration af adalimumab.
English: • Hold the syringe as shown (see Figure I).
Danish: • Hold sprøjten som vist (se Figur I).
English: Figure 2: Kaplan-Meier curves summarizing time to treatment failure on or after week 6 (study UV I) or week 2 (study UV II)
Danish: Figur 2: Kaplan-Meier-kurver opsummerer tid til behandlingssvigt i eller efter uge 6 (studie UV I) eller uge 2 (Studie UV II)
English: Because of the nature of the adverse events seen with the combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNF-antagonists.
Danish: På grund af typen af bivirkningerne observeret ved kombinationen af etanercept og anakinra er der risiko for lignende toksicitet ved kombination af anakinra og andre TNF-antagonister.
English: The safety and efficacy of adalimumab was assessed in two studies (pJIA I and II) in children with active polyarticular or polyarticular course juvenile idiopathic arthritis, who had a variety of JIA onset types (most frequently rheumatoid-factor negative or positive polyarthritis and extended oligoarthritis).
Danish: Adalimumabs sikkerhed og virkning blev vurderet i to studier (pJIA I og II) hos børn med aktiv polyartikulær eller polyartikulært forløb af juvenil idiopatisk artrit, som havde en række forskellige JIA-typer (hyppigst reumatoid-faktor-negativ eller -positiv polyartrit og udvidet oligoartrit).
English: A greater proportion of patients on adalimumab had no disease flare during the double-blind period, when compared with those on placebo (70.4% vs. 47.1%, p<0.001) (Figure 1).
Danish: En større del af patienterne på adalimumab havde ingen opblussen af sygdommen i den dobbeltblinde periode ved sammenligning med dem på placebo (70,4 % versus 47,1 p<0,001) (Figur 1).
English: The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, and sinusitis.
Danish: Infektionerne var primært nasofaryngitis, øvre luftvejsinfektioner og sinuitis.
English: • never leave the syringe unattended where others might tamper with it.
Danish: • aldrig efterlader sprøjten uden opsyn, hvor andre kan komme i kontakt med den.
English: In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used:
Danish: Hvis der er brug for et hurtigere behandlingsrespons, kan nedenstående dosis anvendes med opmærksomheden rettet mod, at risikoen for bivirkninger kan være øget med den højere induktionsdosering:
English: In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Hefiya should be considered prior to initiating therapy (see Other opportunistic infections).
Danish: Hos patienter, som har været eksponeret for tuberkulose, og patienter, som har rejst i områder med høj risiko for tuberkulose eller endemisk mykose, såsom histoplasmose, kokcidioidomykose eller blastomykose, skal risiko og fordele ved behandling med Hefiya overvejes, inden behandlingen iværksættes (se Andre opportunistiske infektioner).
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Hefiya and is positive for antibodies against double-stranded DNA, further treatment with Hefiya should not be given (see section 4.8).
Danish: Hvis en patient efter behandling med Hefiya udvikler symptomer, der tyder på et lupus-lignende syndrom, og er positiv for antistoffer mod dobbeltstrenget DNA, bør der ikke gives yderligere behandling med Hefiya (se pkt.
English: Hepatosplenic T-cell lymphoma1) Merkel cell carcinoma (neuroendocrine carcinoma of the skin)1)
Danish: Hepatosplenisk T-celle-lymfom1), Merkelcellekarcinom (neuroendokrint karcinom)1)
English: • impotence;
Danish: • impotens
English: Muscle spasms (including blood creatine phosphokinase increased)
Danish: Muskelspasmer (inklusive forhøjet niveau af kreatinfosfokinase i blodet)
English: Non-infectious uveitis in adults and children
Danish: Ikke-infektiøs uveitis hos voksne og børn
English: If you have ulcerative colitis you will first be given other medicines.
Danish: Hvis du har colitis ulcerosa, vil du først få anden medicin.