FrancophonIA/ELRC3.0 huggingface dataset:
English: 6.4 Remove the needle from the skin, being careful to pull it out at the same angle that it was inserted.
Danish: 6.4 Træk kanylen ud af huden - vær omhyggelig med at gøre det i samme vinkel, som da den blev stukket ind.
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: Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section
Danish: Aktiv tuberkulose eller andre alvorlige infektioner, såsom sepsis og opportunistiske infektioner (se pkt.
English: Adalimumab may cross the placenta into the serum of infants born to women treated with adalimumab during pregnancy.
Danish: Adalimumab kan passerere placenta og findes i serum hos spædbørn født af kvinder behandlet med adalimumab under graviditeten.
English: Administration of Kromeya should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Danish: Administration af Kromeya bør ophøre, hvis en patient udvikler en ny alvorlig infektion eller sepsis, og passende antimikrobiel eller antimykotisk behandling iværksættes, indtil infektionen er under kontrol.
English: After Use
Danish: Efter brug
English: In the open-label extension of RA study III, the reduction in rate of progression of structural damage is maintained for 8 and 10 years in a subset of patients.
Danish: I den åbne forlængelse af RA-studie III opretholdtes reduktionen i progressionshastigheden af strukturel ødelæggelse i 8 og 10 år hos en delmængde af patienterne.
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.
English: Rhabdomyolysis, systemic lupus erythematosus
Danish: Rabdomyolyse, systemisk lupus erythematosus
English: Refer to package leaflet for alternative storage details.
Danish: Se indlægssedlen vedrørende alternative opbevaringsbetingelser.
English: 6.5 Center your thumb or forefinger on the textured finger pad and push the safety cover forward over the needle until you hear or feel it locks.
Danish: 6.5 Anbring tommel- eller pegefingeren midt på den nubrede fingerflade, og skub kanylebeskyttelsen ned over kanylen, til du kan høre eller mærke, at den låser.
English: Number of patients at baseline n (%)
Danish: Antal patienter ved baseline n (%)
English: The decision to stop using Kromeya should be discussed with your child's doctor.
Danish: Beslutningen om at stoppe med at bruge Kromeya skal diskuteres med dit barns læge.
English: NA 24.0% 58.9%
Danish: NA NA 24,0% 58,9%
English: Your child's symptoms may return upon stopping treatment.
Danish: Dit barns symptomer kan komme igen efter ophør med behandlingen.
English: This evaluation should include a detailed medical assessment of patient history of tuberculosis or possible previous exposure to people with active tuberculosis and previous and/or current immunosuppressive therapy.
Danish: Denne undersøgelse bør omfatte patientens detaljerede sygdomshistorie med tuberkuloseanamnese eller eventuel tidligere eksponering for personer med aktiv tuberkulose samt tidligere og/eller aktuel immunsuppressiv behandling.
English: The percent of adalimumab-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
Danish: Den procent af adalimumab-behandlede patienter, der fik ACR 20-, 50- og 70-respons, var konsistent mellem RA-studie I, II og III.
English: Your doctor will decide if your child should receive Kromeya.
Danish: Din læge vil beslutte, om dit barn skal have Kromeya.
English: • Contact your healthcare professional or pharmacist if you have question or need support.
Danish: • Kontakt lægen eller apotekspersonalet, hvis du har spørgsmål eller har brug for hjælp.
English: The Patient Reminder Cards (adult and paediatric) contain the following key elements: - infections, including tuberculosis - cancer - nervous system problems - vaccinations
Danish: Patientkortet (voksne og børn) indeholder følgende hovedelementer - infektioner, inklusive tuberkulose - cancer - problemer med nervesystemet - vaccinationer
English: This will unlock the injection button (Figure O).
Danish: Det vil frigøre injektionsknappen (figur O).
English: Week 26 Week 52 p value for Standard Dose versus Low Dose comparison.
Danish: Uge 26 Uge 52, 1 p-værdi for sammeligning af standard-dosis versus lav-dosis.
English: Assessment of SpondyloArthritis international Society Baseline is defined as open label baseline when patients have active disease.
Danish: Delvis opblussen af sygdomd a Assessment of SpondyloArthritis international Society b Baseline er defineret som åben periode baseline, når patienterne har aktiv sygdom.
English: • hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
Danish: • hepatosplenisk T-celle lymfom (en sjælden form for blodkræft, som ofte er dødelig)
English: 73% of patients enrolled in Psoriasis Studies I and II had received prior systemic therapy or phototherapy.
Danish: 73% af patienterne i Psoriasisstudie I og II havde tidligere fået systemisk behandling eller lysbehandling.
English: The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.45-2.73) with RA and CD combined.
Danish: Den korrigerede OR (som tager højde for baseline forskelle) var 1,10 (95% KI 0,45-2,73) for RA og CD kombineret.
English: A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e., not identical to the TSS used for rheumatoid arthritis), was used.
Danish: Der blev anvendt en modificeret Total Sharp-score (mTSS), som medtog distale interfalangealled (dvs. ikke identisk med den TSS, som anvendes ved reumatoid artritis).
English: Carriers of HBV who require treatment with Kromeya should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Danish: Bærere af HBV, som kræver behandling med Kromeya, bør overvåges tæt for tegn og symptomer på aktiv HBV-infektion gennem behandlingen og i adskillige måneder efter afslutningen af behandlingen.
English: In study UC-II, treatment with adalimumab resulted in improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ) score.
Danish: I studie UC-II resulterede behandling med adalimumab i forbedringer i score i det tarmsygdomsspecifikke -spørgeskema (IBDQ).
English: 4.3 Pull the needle packaging off.
Danish: 4.3 Træk kanylens emballage af.
English: • autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);
Danish: • autoimmun hepatitis (leverbetændelse forårsaget af kroppens eget immunsystem)
English: Corticosteroid taper was permitted after week
Danish: Nedtrapning af kortikosteroid var tilladt efter uge 8.
English: Figure Q Warning: Call your healthcare professional or pharmacist if you have any problem.
Danish: Figur Q Advarsel: Kontakt lægen eller apotekspersonalet, hvis du har problemer.
English: The decision to stop using Kromeya should be discussed with your doctor.
Danish: Beslutningen om at stoppe med at bruge Kromeya skal diskuteres med din læge.
English: These infections may be more serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other unusual infectious organisms and sepsis (blood poisoning).
Danish: Disse infektioner kan være mere alvorlige og inkluderer tuberkulose, infektioner forårsaget af virus, svampe, parasitter eller bakterier eller andre usædvanlige infektionsorganismer og sepsis (blodforgiftning).
English: Kromeya treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Kromeya is indicated.
Danish: Behandling med Kromeya bør initieres og superviseres af speciallæger med erfaring i diagnosticering og behandling af de sygdomme, som Kromeya er indiceret til.
English: In subjects treated with adalimumab with no radiographic progression from baseline to week 48 (n=102), 84% continued to show no radiographic progression through 144 weeks of treatment.
Danish: Af de forsøgspersoner, som blev behandlet med adalimumab uden at vise progression radiografisk fra baseline til uge 48 (n=102), viste 84 % fortsat ingen progression radiografisk i løbet af de 144 ugers behandling.
English: Kromeya contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Danish: Kromeya indeholder det aktive stof adalimumab; en medicin, som virker på din krops immunsystem.
English: The target of adalimumab is another protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above.
Danish: Målet for adalimumab er et andet protein kaldet tumornekrosefaktor (TNF), som er til stede i øgede mængder ved de inflammatoriske sygdomme nævnt ovenfor.
English: Among the patients who discontinued the study prior to week 78, 11% discontinued due to adverse events, and 5% due to insufficient response to adalimumab treatment.
Danish: Blandt de patienter, der afbrød studiet inden uge 78, blev 11% afbrudt på grund af bivirkninger og 5% på grund af utilstrækkelig respons på adalimumab behandling.
English: Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged),
Danish: Forstyrrelser i koagulationssystemet og af blødning (inklusive forlænget aktiveret partiel tromboplastintid),
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. i det væsentlige ”natriumfri”.
English: In patients with Crohn's disease, a reduction of the number of cells expressing inflammatory markers in the colon including a significant reduction of expression of TNFα was seen.
Danish: Hos patienter med Crohns sygdom sås en reduktion i antallet af celler med ekspression af inflammatoriske markørere i colon, inklusive en betydelig reduktion i antallet af celler med TNFα-ekspression.
English: Over all 19 subjects, of which 11 of the baseline age group 4 to 12 and 8 of the baseline age group 13 to 17 years were treated 6 years or longer.
Danish: I alt blev 19 forsøgspersoner, heraf 11 fra baseline-aldersgruppen 4 til 12 år og 8 fra baselinealdersgruppen 13 til 17 år behandlet i 6 år eller mere.
English: If you use less Kromeya than you should
Danish: Hvis du har givet mindre Kromeya, end du skulle
English: Be sure that you read, understand, and follow these Instructions for Use before injecting Kromeya.
Danish: Sørg for at læse, forstå og følge denne brugsvejledning, før du injicerer Kromeya.
English: In patients who develop HBV reactivation, Kromeya should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Danish: Hos patienter, der udvikler reaktivering af HBV, bør Kromeya seponeres og effektiv anti-viral behandling med passende understøttende behandling initieres.
English: Warning: Do not lift the pre-filled pen from the skin until the plunger has moved all the way down and all the liquid has been injected.
Danish: Advarsel: Du må ikke løfte pennen fra huden, før stemplet er kommet helt i bund, og al væsken er injiceret.
English: • Can be closed with a tight-fitting, puncture-resistant lid; that will keep sharps from coming out,
Danish: • der kan lukkes med et tætsluttende, punktur-resistent låg, så skarpe genstande ikke kan komme ud,
English: Results from the Short Form Health Survey (SF 36) for all doses/schedules of adalimumab in all four studies support these findings, with statistically significant physical component summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
Danish: Resultater fra Short Form Health Survey (SF 36) for alle doser/skemaer for adalimumab i alle fire studier understøtter disse resultater med statistisk signifikant værdi for physical component summary (PCS) såvel som med statistisk signifikant værdi for smerte- og vitalitetsområde for 40 mg dosering hver anden uge.
English: Treatment with Kromeya should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Danish: Behandling med Kromeya bør ikke initieres hos patienter med aktive infektioner, herunder kroniske eller lokaliserede infektioner, før infektionerne er under kontrol.
English: • Made of a heavy-duty plastic;
Danish: • der er lavet af hård plast,
English: Before initiation of therapy with Kromeya, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Danish: Før behandling med Kromeya påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkulose.
English: Patients should be tested for HBV infection before initiating treatment with Kromeya.
Danish: Patienter bør testes for HBV-infektion inden behandling med Kromeya.
English: These infections have not consistently been recognised in patients taking TNFantagonists 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: PROBABILITY OF FAILING TREATMENT
Danish: SANDSYNLIGHEDEN FOR BEHANDLINGSSVIGT
English: Treatment with Kromeya can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Danish: Behandling med Kromeya kan initieres i kombination med kortikosteroider og/eller andre ikke biologiske immunmodulerende lægemidler.
English: Adalimumab was numerically favoured for the majority of subscores with statistically significant mean differences for general vision, ocular pain, near vision, mental health, and total score in study UV I, and for general vision and mental health in study UV II.
Danish: Adalimumab havde numerisk en fordel ved de fleste af underscorerne med statistisk signifikante gennemsnitlige forskelle i generelt syn, okulær smerte, nærsyn, mental sundhed og totalscore i studie UV I og for generelt syn og mental sundhed i Studie UV II.
English: Moderate to severe heart failure (NYHA class III/IV) (see section 4.4).
Danish: Moderat til alvorlig hjerteinsufficiens (NYHA, klasse III/IV) (se pkt.
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Danish: Under vedligeholdelsesbehandling kan kortikosteroider nedtrappes i overenstemmelse med retningslinier for klinisk praksis.
English: The active ingredient in Kromeya, adalimumab, is a monoclonal antibody.
Danish: Det aktive stof i Kromeya, adalimumab, er et monoklonalt antistof.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including adalimumab in the post marketing setting.
Danish: Der er rapporteret om maligne lidelser, i visse tilfælde letale, hos børn, unge og unge voksne (op til 22 år), som blev behandlet med TNF-antagonister (initiering af behandling før 18-års alderen), inklusive adalimumab post marketing.
English: Read all of this leaflet carefully before your child starts using this medicine because it contains important information.
Danish: Læs hele denne indlægsseddel grundigt, inden dit barn begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: Via delle Magnolie 15 I-70026 Modugno (Bari) Italy
Danish: Via delle Magnolie 15 I-70026 Modugno (Bari) Italien
English: Again slowly pull the plunger out to the prescribed dose and stop.
Danish: Træk igen stemplet langsomt ud, og fyld sprøjten med den ordinerede dosis, og stop.
English: 1.5 Check your records for injection dates and injection sites to figure out the injection site for this session.
Danish: 1.5 Tjek dine registreringer af datoer og injektionssteder, og bestem det nye injektionssted.
English: Doing so could damage the syringe or activate the clear needle guard.
Danish: Det vil kunne beskadige injektionssprøjten eller aktivere den gennemsigtige kanylebeskyttelse.
English: Your doctor may recommend temporarily stopping Kromeya.
Danish: Din læge kan anbefale midlertidig afbrydelse af Kromeya.
English: It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis.
Danish: Det er meget vigtigt, at du informerer din læge, hvis du nogensinde selv har haft tuberkulose, eller hvis du har været i tæt kontakt med nogen, som har haft tuberkulose.
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies including spontaneous reporting data
Danish: 4.3, 4.4 og 4.8 ** inklusive åben-label forlængelsesstudier 1) inklusive spontane rapporter
English: Warning: Call your healthcare professional if you did not inject the full dose.
Danish: Advarsel: Kontakt lægen, hvis du ikke har injiceret hele dosen.
English: Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive postBaseline visits
Danish: 2 immunmodulerende lægemidler kunne kun seponeres ved eller efter uge 26 efter investigators skøn, hvis patienten opfyldte det kliniske respons-kriterium 3 defineret som lukning af alle fistler, som var åbne ved baseline, ved mindst 2 på hinanden følgende besøg efter baseline-besøget
English: Reports included cases of pulmonary and extra-pulmonary (i.e. disseminated) tuberculosis.
Danish: Rapporterne indeholder tilfælde af lungetuberkulose og ekstra-pulmonal(f.eks. dissemineret) tuberkulose.
English: • Merkel cell carcinoma (a type of skin cancer);
Danish: • Merkelcelle karcinom (en type hudkræft)
English: Patients who develop a new infection while undergoing treatment with Kromeya, should be monitored closely and undergo a complete diagnostic evaluation.
Danish: Patienter, der udvikler en ny infektion under behandling med Kromeya, bør monitoreres nøje og gennemgå en fuldstænding diagnostisk evaluering.
English: • In some patients the body may fail to produce enough of the blood cells that help your child's body fight off infections or help him/her to stop bleeding.
Danish: • Hos nogle patienter vil kroppen ikke producere tilstrækkeligt af de blodlegemer, som hjælper dit barns krop med at bekæmpe infektioner eller stoppe blødninger.
English: After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 mL/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks.
Danish: Efter doser på 0,5 mg/kg (~ 40 mg) var clearance 11-15 ml/time, fordelingsvolumen (Vss) var mellem 5 og 6 liter, og den gennemsnitlige terminale halveringstid var cirka to uger.
English: The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5.9% for patients taking adalimumab and 5.4% for control treated patients.
Danish: Andelen af patienter, som ophørte med behandling på grund af bivirkninger i løbet af den dobbeltblindede, kontrollerede del af de pivotalestudier, udgjorde 5,9 % for patienter, der fik adalimumab, og 5,4 % for kontrolbehandlede patienter.
English: The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1-6 μg/ml).
Danish: Den tilsyneladende plasmakoncentation af adalimumab som giver 50 % sandsynlighed for PedACR 50 respons (EC50) var 3 μg/ml (95% CI: 1-6 μg/ml).
English: Of the 417 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 46 subjects were regarded ineligible (e.g. developed complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
Danish: Af de 417 patienter, der indgik i den ukontrollerede langtidsforlængelse af studierne UV I og UV II, blev 46 patienter anset for ikke egnede (f.eks. udviklede komplikationer sekundært til diabetisk retinopati på grund af kataraktkirurgi eller vitrektomi) og blev udelukket fra den primære effektanalyse.
English: Discontinuation of immunomodulators2
Danish: Seponering af immunomodulerendemidler2
English: • Do not shake.
Danish: • Må ikke rystes.
English: Adalimumab treated patients had significantly greater improvement at week 12 which was maintained through week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).
Danish: Patienter i behandling med adalimumab havde signifikant større forbedringer ved uge 12, som blev opretholdt frem til uge 24, i både SF36 og ankyloserende spondylitis livskvalitetsspørgeskema (ASQoL).
English: During the withdrawal period, symptoms of psoriasis returned over time with a median time to relapse (decline to PGA “moderate” or worse) of approximately 5 months.
Danish: I den behandlingsfri periode vendte psoriasissymptomer tilbage over tid med en gennemsnitstid til tilbagefald (fald til PGA “moderat” eller derunder) på omkring 5 måneder.
English: Neither carcinogenicity studies, nor a standard assessment of fertility and postnatal toxicity, were performed with adalimumab due to the lack of appropriate models for an antibody with limited cross-reactivity to rodent TNF and to the development of neutralizing antibodies in rodents.
Danish: Hverken karcinogenicitetsstudier eller standardvurdering af fertilitet og postnatal toksicitet blev udført med adalimumab, da der ikke findes passende modeller for et antistof med begrænset krydsreaktivitet over for gnaver-TNF og til udviklingen af neutraliserende antistoffer hos gnavere.
English: Formation of antiadalimumab antibodies is associated with increased clearance and reduced efficacy of adalimumab.
Danish: Dannelse af adalimumab-antistoffer er forbundet med øget clearence og reduceret effekt af adalimumab.
English: After 5 years of adalimumab therapy, 74.0% (37/50) of the 50 patients remaining in the study continued to be in clinical remission, and 92.0% (46/50) of patients continued to be in clinical response per PCDAI.
Danish: Efter 5 års adalimumab-behandling var 74,0% (37/50) af de 50 patienter, som stadig var i studiet, fortsat i klinisk remission, og 92,0% (46/50) af patienterne havde fortsat klinisk respons i henhold til PCDAI.
English: One hundred patients (n=100) from the Paediatric CD study continued in an open-label long-term extension study.
Danish: Ethundrede patienter (n=100) fra det pædiatriske Crohn-studie fortsatte i langtidsbehandling i et åbent forlængelsesstudie.
English: These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and/or gold salts.
Danish: Disse terapier omfatter methotrexat, leflunomid, hydroxychloroquine, sulfasalazin og/eller guldsalt.
English: The frequency of serious infections among adalimumab treated subjects over 65 years of age (3.7%) was higher than for those under 65 years of age (1.5%).
Danish: Hyppigheden af alvorlige infektioner var højere hos adalimumab-behandlede patienter over 65 år (3,7 %) end hos patienter under 65 år (1,5 %).
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 (ELAM1, VCAM-1 og ICAM-1 med en IC50 på 0,1-0,2 nM).
English: Age group
Danish: Aldersgruppe