FrancophonIA/ELRC3.0 huggingface dataset:
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of AMGEVITA should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en anafylaktisk reaktion eller andre alvorlige allergiske reaktioner, bør behandling med AMGEVITA straks ophøre og egnet behandling påbegyndes.
English: JSNd score a methotrexate b 95% confidence intervals for the differences in change scores between methotrexate and adalimumab c Based on rank analysis d Joint Space Narrowing
Danish: JSNd score a methotrexat b 95 % Konfidensintervaller for forskellen i ændring af score mellem methotrexat og adalimumab c Baseret på ranganalyse d Ledspalteforsnævring
English: AMGEVITA treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which AMGEVITA is indicated.
Danish: Behandling med AMGEVITA bør initieres og superviseres af speciallæger med erfaring i diagnosticering og behandling af de sygdomme, som AMGEVITA er indiceret til.
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 antallet af suppurerende fistler i forhold til baseline).
English: Radiographic mean changes over 12 months in RA study III
Danish: Gennemsnitlige radiografiske ændringer gennem 12 måneder i RA-studie III
English: Hepatitis,
Danish: Hepatit,
English: The European Medicines Agency has deferred the obligation to submit the results of 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, som indeholder adalimumab i en eller flere undergrupper af den pædiatriske population med colitis ulcerosa (se pkt.
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 AMGEVITA 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 AMGEVITA skal omgående afbrydes.
English: AMGEVITA can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.
Danish: AMGEVITA kan nedsætte antallet af knuder og bylder og lindre den smerte, som ofte er forbundet med sygdommen.
English: When done, release your thumb, and gently lift the syringe off of your skin.
Danish: Fjern din tommeltot, når du er færdig, og løft forsigtigt injektionssprøjten væk fra huden.
English: If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate.
Danish: Hvis du har moderat til alvorlig aktiv reumatoid artrit, vil du evt først få andre sygdomsmodificerende antireumatiske lægemidler, såsom methotrexat.
English: • serious infections (including blood poisoning and influenza);
Danish: • alvorlige infektioner (inklusive blodforgiftning og influenza),
English: If active tuberculosis is diagnosed, AMGEVITA therapy must not be initiated (see section 4.3).
Danish: Hvis der diagnosticeres aktiv tuberkulose, må AMGEVITA-terapi ikke påbegyndes (se pkt.
English: Patients treated with AMGEVITA should be given the Patient Reminder Card.
Danish: Patienter i AMGEVITA-behandling bør få udleveret et patientkort.
English: ● Do not use any medicine that is left in the used syringe.
Danish: ● Brug ikke eventuel resterende medicin, der er tilovers i den brugte injektionssprøjte.
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: 79 (73.1) a, b a p < 0.001 adalimumab versus placebo b p < 0.001 adalimumab versus methotrexate c p < 0.01 adalimumab versus placebo d p < 0.05 adalimumab versus methotrexate
Danish: 79 (73,1) a, b a p<0,001 adalimumab versus placebo b p<0,001 adalimumab versus methotrexat c p<0,01 adalimumab versus placebo d p<0,05 adalimumab versus methotrexat
English: Demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome)1)
Danish: Demyeliniserende sygdomme (f.eks. opticus neuritis, Guillain-Barré syndrom)1)
English: A patient who requires surgery while on AMGEVITA should be closely monitored for infections, and appropriate actions should be taken.
Danish: En patient, som har behov for et kirurgisk indgreb under behandling med AMGEVITA, bør monitoreres tæt for infektioner, og der skal tages passende forholdsregler.
English: Formation of antiadalimumab antibodies is associated with increased clearance and reduced efficacy of adalimumab.
Danish: Dannelse af adalimumabantistoffer er forbundet med øget clearance og reduceret effekt af adalimumab.
English: • Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash);
Danish: • Stevens-Johnsons syndrom (tidlige symptomer inkluderer utilpashed, feber, hovedpine og udslæt),
English: AMGEVITA is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Danish: AMGEVITA bruges til at behandle hidrosadenitis suppurativa hos voksne og unge fra 12 år.
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: 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: Put the original package with any unused pre-filled pens back in the refrigerator.
Danish: Læg den originale pakning med eventuelle ubrugte penne i køleskabet igen.
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: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open-label extension studies
Danish: 4.3, 4.4 og 4.8 ** inklusive åben-label forlængelsesstudie 1) inklusive spontane rapporter
English: Step 3: Inject G. Hold the stretch or pinch.
Danish: Trin 3: Injicér G. Bliv ved med at strække eller klemme sammen.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with AMGEVITA and is positive for antibodies against double-stranded DNA, further treatment with AMGEVITA should not be given (see section 4.8).
Danish: Hvis en patient efter behandling med AMGEVITA udvikler symptomer, der tyder på et lupus-lignende syndrom, og er positiv for antistoffer mod dobbelt-strenget DNA, bør der ikke gives yderligere behandling med AMGEVITA (se pkt.
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 ration sammenlignet med placebo (HR = 0,25 [95 % CI: 0,12; 0,49]).
English: B. Inspect the AMGEVITA pre-filled pen.
Danish: B. Kontrollér den fyldte pen.
English: Physicians should exercise caution when considering the use of AMGEVITA 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 AMGEVITA til patienter med anamnese af tilbagevendende infektioner eller med øvrige sygdomstilstande, som kan prædisponere patienterne for infektioner, inklusive samtidig anvendelse af immunsuppressive lægemidler.
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: AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1).
Danish: AMGEVITA kan gives som monoterapi i tilfælde af intolerance over for methotrexat, eller hvis fortsat behandling med methotrexat er uhensigtmæssig (for effektivitet ved monoterapi, se pkt 5.1).
English: Figure 2: Kaplan-Meier curves summarising time to treatment failure on or after week 6 (study UV I) or week 2 (study UV II)
Danish: Figur 2: Kaplan-Meier- kurver opsummere tid til behandlingssvigt i eller efter uge 6 (Studie UV I) eller uge 2 (Studie UV II)
English: If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting AMGEVITA.
Danish: - Hvis du har en infektion, herunder langvarig eller lokaliseret infektion (f.eks. bensår), bør du kontakte din læge, før du begynder at bruge AMGEVITA.
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: In a study of 64 patients with rheumatoid arthritis that were treated with adalimumab, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B-, NK-cells, monocyte/macrophages, and neutrophils.
Danish: I et studie, hvor 64 patienter med reumatoid artrit blev behandlet med adalimumab, var der ingen tegn på nedsat forsinket hypersensitivitet, nedsatte immunglobulinniveauer eller forandring i antallet af effektor T-, B-, NK-celler, monocytter/makrofager og neutrofiler.
English: The symptoms described above can be signs of the below listed side effects, which have been observed with adalimumab.
Danish: Ovennævnte symptomer kan være tegn på følgende bivirkninger, som er observeret ved brug af adalimumab.
English: Put the original package with any unused syringes back in the refrigerator.
Danish: Læg den originale pakning med eventuelle ubrugte injektionssprøjter i køleskabet igen.
English: Improvement in number of active joints with arthritis was maintained during the OL period through week 156 for the 26 of 31 (84%) patients in the adalimumab group who remained in the study.
Danish: Forbedring i antallet af led med aktiv artrit blev opretholdt i den åbne del af studiet i 156 uger for 26 ud af 31 (84%) patienter i adalimumab-gruppen, der fortsatte i studiet.
English: - The yellow cap is missing or not securely attached.
Danish: - Den gule hætte mangler eller sidder ikke ordentligt på.
English: C. Gather all materials needed for your injection(s).
Danish: C. Saml alle de materialer, du skal bruge til injektionen (injektionerne).
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTX
Danish: I den åbne indkøringsfase blev patienterne stratificeret i to grupper - MTX-behandlede (methotrexat-behandlede) og ikke-MTX
English: *P < 0.05, ***P < 0.001, adalimumab versus placebo a Among all randomised patients b Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0 - 10; 0 = no skin pain, 10 = skin pain as bad as you can imagine
Danish: * p < 0,05, ***p < 0,001, adalimumab versus placebo a Blandt alle randomiserede patienter b Blandt patienter med baseline HS-relateret evaluering af hudsmerte ≥ 3, baseret på en numerisk vurderingsskala 0-10; 0 = ingen hudsmerte, 10 = hudsmerte så slem, som du kan forestille dig
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/methotrexatkombinationsterapi 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: Usually, AMGEVITA is used with methotrexate.
Danish: Normalt gives AMGEVITA sammen med methotrexat.
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 AMGEVITA.
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 AMGEVITA påbegyndes.
English: Hypokalaemia, Uric acid increased, Blood sodium abnormal, Hypocalcaemia, Hyperglycaemia, Hypophosphatemia, Dehydration
Danish: Hypokaliæmi, Forhøjet urinsyre, Unormal blod-natrium, Hypokalcæmi, Hyperglykæmi, Hypofosfatæmi, Dehydrering
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of AMGEVITA, and in accordance with local recommendations.
Danish: Hvis der diagnosticeres ‘latent' tuberkulose, skal profylaktisk behandling mod tuberkulose påbegyndes i overensstemmelse med lokale anbefalinger, inden behandling med AMGEVITA startes.
English: ● Do not try to warm the pre-filled pen by using a heat source such as hot water or microwave.
Danish: ● Forsøg ikke at opvarme pennen ved hjælp af en varmekilde, for eksempel varmt vand eller mikrobølgeovn.
English: • signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,
Danish: • tegn og symptomer, som kan tyde på blodsygdomme så som vedvarende feber, blå mærker,
English: ● Do not use an AMGEVITA pre-filled pen if it has been dropped on a hard surface.
Danish: ● Brug ikke en fyldt pen, hvis den har været tabt på en hård flade.
English: In post-marketing experience from January 2003 to December 2010, predominantly in patients with rheumatoid arthritis, the reported rate of malignancies is approximately 2.7 per 1,000 patient treatment years.
Danish: Der er ved post-marketing erfaring fra januar 2003 til december 2010, hovedsageligt hos patienter med reumatoid artrit rapporteret en hyppighed af maligniteter på cirka 2,7 pr. 1.000 patient-behandlingsår, hovedsageligt hos patienter med reumatoid artrit.
English: • impotence;
Danish: • impotens,
English: The posology of AMGEVITA in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Danish: AMGEVITA-dosis hos disse patienter er fastlagt ud fra farmakokinetiske modeller og simulering (se pkt.
English: This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. 0,8 ml dosis, dvs. det er i det væsentlige ”natriumfrit”.
English: Paediatric ACR 30 responses in the JIA study
Danish: Pædiatrisk ACR 30-respons i JIA-studiet
English: a HR of adalimumab versus placebo from proportional hazards regression with treatment as factor.
Danish: a HR af adalimumab vs placebo ved regressionsanalyse med behandling som baggrundsvariabel.
English: ● Do not use the syringe if: - The medicine is cloudy or discoloured or contains flakes, or particles.
Danish: ● Brug ikke sprøjten, hvis: - Medicinen er grumset eller misfarvet eller indeholder flager eller partikler.
English: A total of 233 PASI 75 responders at week 16 and week 33 received continuous adalimumab therapy for 52 weeks in psoriasis study I, and continued adalimumab in the open-label extension trial.
Danish: I alt 233 PASI 75-respondenter ved uge 16 og 33 fik kontinuerlig adalimumab-behandling i 52 uger i Psoriasis-studie I og fortsatte med adalimumab i det åbne forlængelsesstudie.
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 JIAtyper (hyppigst reumatoid-faktor-negativ eller -positiv polyartrit og udvidet oligoartrit).
English: If you stop using AMGEVITA
Danish: Hvis du holder op med at tage AMGEVITA
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: If you forget to use AMGEVITA
Danish: Hvis du har glemt at tage AMGEVITA
English: • neurological infections (including viral meningitis);
Danish: • neurologiske infektioner (inklusive viral meningitis),
English: After 16 weeks of therapy, patients who achieved at least a PASI 75 response (PASI score improvement of at least 75% relative to baseline), entered period B and received open-label 40 mg adalimumab every other week.
Danish: Efter 16 ugers behandling gik de patienter, der mindst havde opnået et PASI 75-respons (forbedring i PASI-score på mindst 75 % i forhold til baseline), over i periode B og fik åben 40 mg adalimumab hver anden uge.
English: ● Do not use the pre-filled pen if: - The medicine is cloudy or discoloured, or contains flakes or particles.
Danish: ● Brug ikke den fyldte pen, hvis: - Medicinen er grumset eller misfarvet eller indeholder flager eller partikler.
English: Therefore, the combination of AMGEVITA and anakinra is not recommended (see section 4.5).
Danish: Kombination af AMGEVITA og anakinra anbefales ikke (se pkt.
English: Patients who were in the non-MTX stratum were either naïve to or had been withdrawn fromMTX at least two weeks prior to study drug administration.
Danish: Patienter i stratummet af ikke-MTX-behandlede var enten aldrig blevet behandlet medMTX eller havde fået seponeret MTX mindst to uger før administration af studielægemidlet.
English: In RA study IV, the ACR 20 response of patients treated with adalimumab plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
Danish: I RA-studie IV var ACR 20-respons for patienter behandlet med adalimumab plus standardpleje statistisk signifikant bedre end for patienter behandlet med placebo plus standardpleje (p< 0,001).
English: • Children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.
Danish: • Børn fra 2 år med kronisk ikke-infektiøs uveitis, som påvirker forreste del af øjet.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: SPARCC MRI Spined,j a Assessment of SpondyloArthritis international Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n = 91 placebo and n = 87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n = 73 placebo and n = 70 adalimumab h Spondyloarthritis Research Consortium of Canada i n = 84 placebo and adalimumab j n = 82 placebo and n = 85 adalimumab ***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between adalimumab and placebo
Danish: SPARCC MRI rygsøjlend,j a Assessments of SpondyloArthritis international Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d gennemsnitlig ændring fra baseline e n = 91 placebo og n = 87 adalimumab f høj følsomhed C-reaktivt protein (mg/l) g n = 73 placebo and n = 70 adalimumab h Spondyloarthritis Research Consortium of Canada i n = 84 placebo og adalimumab j n = 82 placebo og n = 85 adalimumab ***, **, * Statistisk signifikant ved henholdvis p < 0,001, < 0,01 og < 0,05 for alle sammenligninger mellem adalimumab og placebo
English: In RA studies I-IV, all individual components of the ACR response criteria (number of tender and swollen joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores and CRP (mg/dL) values) improved at 24 or 26 weeks compared to placebo.
Danish: I RA-studie I-IV forbedredes alle individuelle komponenter af ACR-responskriterierne (antal af ømme og hævede led, læge- og patientvurderinger af sygdomsaktivitet og smerter, fysisk funktionsevneindeksværdier (HAQ) og CRP (mg/dl)-værdier efter 24 eller 26 uger sammenlignet med placebo.
English: 14 weeks a Paediatric ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015
Danish: 14 uger a Pædiatrisk ACR 30/50/70-responser ved uge 48 er signifikant bedre end responserne for placebobehandlede patienter b p = 0,015 c p = 0,031
English: • angioedema (localised swelling of the skin);
Danish: • angioødem (lokal hævelse af huden),
English: Pull the yellow cap straight off when you are ready to inject.
Danish: Træk den gule hætte lige af, når du er klar til at give injektionen.
English: At week 12, a significantly higher proportion of patients in study HS-II experienced a clinically relevant decrease in HS-related skin pain (see table 21).
Danish: En signifikant højere andel af patienterne i HS-II-studie oplevede et klinisk relevant fald i HS-relateret hudsmerte (se tabel 21) ved uge 12.
English: There is insufficient evidence of the efficacy of adalimumab in patients with ankylosing spondylitislike 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: Part of the AMGEVITA pre-filled pen may be broken even if you cannot see the break.
Danish: Dele af pennen kan være ødelagt, også selvom du ikke kan se noget brud.
English: Mood alterations (including depression), Anxiety,
Danish: Humørsvingninger (inklusive depression), Angst,