FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you are about to have surgery or dental procedures tell your doctor that you are taking Hefiya.
Danish: • Hvis du skal opereres eller have tandbehandling, skal du fortælle din læge, at du tager Hefiya.
English: • Insert the needle into your skin as shown.
Danish: • Stik kanylen ind i huden som vist.
English: Overall responses were generally better and, fewer patients developed antibodies when treated with the combination of adalimumab and MTX compared to adalimumab alone.
Danish: Det samlede respons var generelt bedre og færre patienter udviklede antistoffer, når de blev behandlet med kombinationen adalimumab og MTX sammenlignet med adalimumab alene.
English: The serum levels of free adalimumab (not bound to anti-adalimumab antibodies, AAA) were observed to be lower in patients with measurable AAA.
Danish: Serumniveauet i frit adalimumab (dvs. ikke bundet til anti-adalimumab-antistoffer, AAA) blev målt til at være lavere hos patienter med målbare anti-adalimumab-antistoffer.
English: • Do not use if the safety seal has been broken
Danish: • Brug den ikke, hvis sikkerhedsforseglingen er brudt.
English: Longer term treatment with adalimumab 40 mg weekly for 96 weeks identified no new safety findings.
Danish: Længere tids behandling med adalimumab 40 mg ugentlig viste ingen nye sikkerhedsfund.
English: response
Danish: respons
English: Hefiya treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Hefiya is indicated.
Danish: Behandling med Hefiya bør initieres og superviseres af speciallæger med erfaring i diagnosticering og behandling af de sygdomme, som Hefiya er indiceret til.
English: The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percentage of patients who achieved an ACR 20 response at week 24 or 26.
Danish: Det primære endepunkt i RA-studie I, II og III og det sekundære endepunkt i RA-studie IV var den procentdel af patienter, som fik ACR 20-respons i uge 24 eller 26.
English: Concurrent treatment with azathioprine/6-mercaptopurine
Danish: Samtidig behandling med azathioprin/6-mercaptopurin
English: • asthma;
Danish: • astma
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 ≤ 18-års alderen), inklusive adalimumab post marketing.
English: − The active substance is adalimumab.
Danish: - Aktivt stof: adalimumab.
English: Contents of the pack and other information What Hefiya contains
Danish: Pakningsstørrelser og yderligere oplysninger Hefiya indeholder
English: Patients should be tested for HBV infection before initiating treatment with Hefiya.
Danish: Patienter bør testes for HBV-infektion inden behandling med Hefiya.
English: Do not rub the injection site.
Danish: Gnid ikke på injektionsstedet.
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)-score såvel som med statistisk signifikant værdi for smerte- og vitalitetsområde for 40 mg dosering hver anden uge.
English: primary analysis (ITT) placebo adalimumab time to treatment failure at or after week 2 in study UV II
Danish: primær analyse (ITT) placebo adalimumab tid til behandlingssvigt i eller efter uge 2 i Studie UV II
English: Mood alterations (including depression), anxiety, insomnia
Danish: Humørsvingninger (inklusive depression), angst, insomni
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 controltreated patients.
Danish: Andelen af patienter, som ophørte med behandling på grund af bivirkninger i løbet af den dobbeltblindede, kontrollerede del af de pivotale studier, udgjorde 5,9 % for patienter, der fik adalimumab, og 5,4 % for kontrolbehandlede patienter.
English: Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Pediatric ACR 50 response, and Pediatric ACR 70 response.
Danish: Selvom det ikke var statistisk signifikant, viste størstedelen af patienterne klinisk bedring i sekundære endepunkter, såsom antallet af steder med entesopatirelateret artrit, antallet af ømme led (TJC), antallet af hævede led (SJC), pædiatrisk ACR50-respons og pædiatrisk ACR70-respons.
English: Table 24 maintenance of clinical remission and response (percent of patients) placebo 40 mg adalimumab every other week
Danish: Tabel 24 Vedligeholdelse af klinisk remission og respons (procent af patienterne) placebo 40 mg adalimumab hver anden uge
English: Be sure that you read, understand, and follow these Instructions for use before injecting Hefiya.
Danish: Sørg for at læse, forstå og følge denne brugsvejledning, før du injicerer Hefiya.
English: Treatment with Hefiya must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Danish: Behandling med Hefiya skal ophøre hos patienter, som udvikler nye eller får forværrede symptomer på hjerteinsufficiens.
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: In patients who develop HBV reactivation, Hefiya should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Danish: Hos patienter, der udvikler reaktivering af HBV, bør Hefiya seponeres og effektiv anti-viral behandling med passende understøttende behandling initieres.
English: If such a dose is required, other adalimumab medicines should be used.
Danish: Hvis sådan en dosis er påkrævet, så skal en anden medicin med adalimumab bruges.
English: Ankylosing spondylitis (AS)
Danish: Ankyloserende spondylitis (AS)
English: Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking.
Danish: Der bør derfor udvises forsigtighed, når der anvendes TNF-antagonister til KOL-patienter og til patienter med en forøget risiko for malignitet på grund af massiv rygning.
English: In a prospective cohort registry, 257 women with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab at least during the first trimester and 120 women with RA or CD not treated with adalimumab were enrolled.
Danish: I et prospektivt kohorte registerstudie, blev 257 kvinder med reumatoid artrit (RA) eller Crohns sygdom (CD) behandlet med adalimumab i minimum det første trimester og 120 kvinder med RA eller CD, som ikke blev behandlet med adalimumab inkluderet.
English: clinical remission clinical response * p-value for standard dose versus low dose comparison.
Danish: klinisk remission klinisk respons * p-værdi for sammenligning af standarddosis versus lavdosis.
English: Figure B: items not included in the carton See “4.
Danish: Figur B: ting, der ikke er inkluderet i pakningen Se ”4.
English: Patients receiving MTX who achieved a ≥PASI 50 response at week 8 and / or 12 did not receive further dose increases.
Danish: Patienter, som fik methotrexat, og som opnåede et ≥ PASI 50-respons ved uge 8 og/eller 12, fik ikke yderligere dosisøgning.
English: The second received 20 mg of adalimumab every week for 52 weeks.
Danish: Den anden fik 20 mg adalimumab hver uge i 52 uger.
English: Moderate to severe heart failure (NYHA class III / IV) (see section 4.4).
Danish: Moderat til svær hjerteinsufficiens (NYHA, klasse III/IV) (se pkt.
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 alvorlige og inkluderer tuberkulose, infektioner forårsaget af virus, svampe, parasitter eller bakterier eller andre usædvanlige infektionsorganismer og sepsis (blodforgiftning).
English: Active tuberculosis or other severe infections such as sepsis, and opportunistic infections
Danish: Aktiv tuberkulose eller andre alvorlige infektioner, såsom sepsis og opportunistiske infektioner (se pkt.
English: Hepatitis B reactivation
Danish: Hepatitis B-reaktivering
English: Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA ≥ 10 % (60 % of patients) and BSA < 10 % and ≥ 5 % (40 % of patients)).
Danish: Adalimumab viste en behandlingsfordel hos patienter med neglepsoriasis med forskellig omfang af hudinvolvering (BSA ≥ 10 % (60 % af patienterne) og BSA < 10 % og ≥5 % (40 % af patienterne)).
English: Patients who develop a new infection while undergoing treatment with Hefiya should be monitored closely and undergo a complete diagnostic evaluation.
Danish: Patienter, der udvikler en ny infektion under behandling med Hefiya, bør monitoreres nøje og gennemgå en fuldstændig diagnostisk evaluering.
English: Table 21 efficacy results at 12 weeks, HS studies I and II
Danish: Tabel 21 Effektresultater ved uge 12, HS-Studie I og II
English: The safety of adalimumab in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months.
Danish: Adalimumabs sikkerhed hos pædiatriske patienter med plaque-psoriasis blev vurderet i gennemsnitligt 13 måneder.
English: Similar trends (not all statistically significant) were seen in the smaller randomised, double-blind, placebo-controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Danish: Lignende tendenser (ikke alle statistisk signifikante) blev set i det mindre, randomiserede, dobbeltblindede, placebokontrollerede AS-studie II på 82 voksne patienter med aktiv ankyloserende spondylitis.
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 tuberkulose i anamnesen eller eventuel tidligere eksponering for personer med aktiv tuberkulose samt tidligere og/eller aktuel immunsuppressiv behandling.
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: The patients improved following discontinuation of therapy.
Danish: Patienternes tilstand forbedredes efter ophør med behandlingen.
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: 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 neutralising 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: RA studies III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
Danish: Studierne III og V havde yderligere primære endepunkter i uge 52 med forsinket sygdomsprogression (bestemt ud fra røntgenresultater).
English: • do not use the syringe if the seals of the blister are broken, as it may not be safe for you to use.
Danish: • ikke bruger sprøjten, hvis forseglingen på blisterkortet er itu, da den i så fald måske ikke er sikker for dig at bruge.
English: Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg / kg / day or 10 mg / day maximum).
Danish: Patienterne fortsatte på faste doser NSAID og/eller prednison (≤ 0,2 mg/kg/dag eller maksimalt 10 mg/dag).
English: This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, that is to say essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol natrium (23 mg) pr. 0,8 ml dosis, dvs. den er i det væsentlige natriumfri.
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: Formation of anti-adalimumab antibodies is associated with increased clearance and reduced efficacy of adalimumab.
Danish: Dannelse af adalimumab-antistoffer er forbundet med øget clearance og reduceret effekt af adalimumab.
English: If you develop a fever that does not go away, or you bruise or bleed very easily or look very pale, call your doctor right away.
Danish: Hvis du får feber, som ikke vil forsvinde, blå mærker eller bløder meget let eller er meget bleg, skal du omgående henvende dig til din læge.
English: Of those patients who had a response at week 8, 47 % were in response, 29 % were in remission, 41 % had mucosal healing, and 20 % were in steroid-free remission for ≥ 90 days at week 52.
Danish: Blandt de patienter, som havde et respons ved uge 8, var 47 % i respons, 29 % var i remission, 41 % havde slimhindeheling, og 20 % var i steroidfri remission i ≥ 90 dage ved uge 52.
English: Demyelinating disease
Danish: Demyeliniserende sygdom
English: Hefiya contains sodium
Danish: Hefiya indeholder natrium
English: The inflammation leads to a decrease of vision and / or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision).
Danish: Inflammationen kan føre til nedsat syn og/eller fluer i øjet (sorte pletter eller sværm af uklarheder i øjet, som bevæger sig i synsfeltet).
English: Note: treatment failure at or after week 6 (study UV I), or at or after week 2 (study UV II), was counted as event.
Danish: Note: behandlingssvigt i eller efter uge 6 (studie UV I) eller i eller efter uge 2 (studie UV II) blev talt med som hændelser.
English: An embryo-foetal developmental toxicity / perinatal developmental study has been performed in cynomolgus monkeys at 0, 30 and 100 mg / kg (9-17 monkeys / group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Danish: Et embryoføtalt udviklingstoksicitets-/perinatalt udviklingsstudie foretaget på cynomolgusaber med 0, 30 og 100 mg/kg (9-17 aber/gruppe) viste ingen tegn på fosterskader på grund af adalimumab.
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 plasmakoncentration af adalimumab som tilsyneladende giver 50 % sandsynlighed for PedACR 50 respons (EC50) var 3 μg/ml (95 % CI: 1-6 μg/ml).
English: • Merkel cell carcinoma (a type of skin cancer);
Danish: • Merkelcellekarcinom (en type hudkræft)
English: • Hold your pen at 90 degrees to the cleaned injection site (see Figure G).
Danish: • Hold din pen i en vinkel på 90° mod det rensede injektionssted (se Figur G).
English: Store in a refrigerator (2°C-8°C).
Danish: Opbevares i køleskab (2 - 8°C).
English: If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.
Danish: Hvis du udvikler nye eller får forværrede symptomer på hjerteinsufficiens (f.eks. stakåndethed eller hævede fødder), skal du kontakte din læge øjeblikkeligt.
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: • serious infections (including blood poisoning and influenza);
Danish: • alvorlige infektioner (inklusive blodforgiftning og influenza)
English: Adalimumab was evaluated in over 3,000 patients in all rheumatoid arthritis clinical trials.
Danish: Adalimumab er vurderet hos mere end 3.000 patienter i de kliniske reumatoid artrit-studier.
English: At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3 %, respectively [P = 0.014]).
Danish: Ved uge 16 havde en statistisk signifikant større andel af de patienter, som fik adalimumab opnået PGA ”clear” eller ”almost clear” for psoriasis på hænder og/eller fødder sammenlignet med patienter, som fik placebo (30,6 % versus 4,3 % [P=0,014]).
English: Vertigo and visual impairment may occur following administration of Hefiya (see section 4.8).
Danish: Vertigo og svækket syn kan forekomme efter administration af Hefiya (se pkt.
English: Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposure-response relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels.
Danish: Adalimumabs virkning til behandling af unge patienter med HS er baseret på den demonstrerede virkning og eksponering-respons-forhold hos voksne HS-patienter og sandsynligheden for, at sygdomsforløb, patofysiologi og lægemidlets virkning i det væsentligste svarer til voksnes ved samme eksponeringsniveau.
English: • Keep the plunger fully pressed down while you carefully lift the needle straight out from the injection site and let go of your skin (see Figure J).
Danish: • Hold stemplet presset helt ned, mens du forsigtigt løfter kanylen lige ud af injektionsstedet og giver slip på din hud (se Figur J).
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Hefiya in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Danish: Inden start af behandling med Hefiya skal profylaktisk behandling mod tuberkulose også overvejes hos patienter med adskillige eller signifikante risikofaktorer for tuberkulose på trods af en negativ test for tuberkulose samt hos patienter, der tidligere har haft latent eller aktiv tuberkulose, hvor det ikke har kunnet bekræftes, at behandlingen har været tilstrækkelig.
English: Leave it to dry before injecting (see Figure F).
Danish: Lad det tørre, før du injicerer (se Figur F).
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: See section 4.8 for how to report adverse reactions.
Danish: 4.8, hvordan bivirkninger indberettes.
English: Quality of Life
Danish: Livskvalitet
English: If active tuberculosis is diagnosed, Hefiya therapy must not be initiated (see section 4.3).
Danish: Hvis der diagnosticeres aktiv tuberkulose, må Hefiya-terapi ikke påbegyndes (se pkt.
English: Ankylosing Spondylitis Disease Activity Score d partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Danish: c Ankylosing Spondylitis Disease Activity Score d Delvis opblussen af sygdom er defineret som ASDAS ≥ 1,3 men < 2,1 ved 2 på hinanden følgende besøg.
English: • Look at the expiration date (EXP) on your syringe.
Danish: • Kontroller udløbsdatoen (EXP) på din sprøjte.
English: If you have questions, please ask your doctor.
Danish: Hvis du har spørgsmål, skal du tale med din læge.
English: Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections.
Danish: Diagnosticering og empirisk antimykotisk behandling af disse patienter bør tages i samråd med en læge med ekspertise i behandling af invasive svampeinfektioner.
English: The primary efficacy endpoint was the proportion of patients with no flare by Week 68 of the study.
Danish: Studiets primære effektmål var andelen af patienter uden opblussen af sygdommen ved uge 68.
English: Tell your doctor if you are taking azathioprine or mercaptopurine with Hefiya.
Danish: Fortæl din læge, hvis du får lægemidlerne azathioprin eller mercaptopurin sammen med Hefiya.
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 i 156 uger for 26 ud af 31 (84 %) patienter i adalimumab-gruppen, som forblev i studiet.
English: After single intravenous doses ranging from 0.25 to 10 mg / kg, concentrations were dose proportional.
Danish: Efter enkeltvise intravenøse doser på mellem 0,25 og 10 mg/kg var koncentrationerne dosisrelaterede.
English: Safety of the recommended adalimumab dose in the adolescent HS population is based on cross-indication safety profile of adalimumab in both adults and paediatric patients at similar or more frequent doses (see section 5.2).
Danish: Sikkerheden af den anbefalede adalimumab-dosis i den unge HS-population er baseret på adalimumabs sikkerhedsprofil på tværs af indikationer hos både voksne og pædiatriske patienter ved samme eller hyppigere dosering (se pkt.
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: 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 (TNFα), som er til stede i øgede mængder i de inflammatoriske sygdomme nævnt ovenfor.