FrancophonIA/ELRC3.0 huggingface dataset:
English: Find a well-lit, clean surface and gather all the equipment you need:
Danish: Find et veloplyst, rent område, og læg alle de ting, du får brug for, frem:
English: 79 (75%)a sPGA “clear” or “minimal”, n (%)
Danish: 79 (75 %)a sPGA ”klar” eller ”minimal”, n ( %)
English: B. Injection steps Step 1:
Danish: B. Injektionstrin Trin 1:
English: cysts and polyps)
Danish: cyster og polypper)
English: ● Keep this card with you for 2 months after the last Benepali dose, since side effects may occur after your last dose of Benepali.
Danish: ● Bær dette kort på dig i 2 måneder efter den sidste Benepali-dosis, da der kan forekomme bivirkninger efter din sidste dosis Benepali.
English: Pull to open
Danish: Træk for at åbne
English: b Values for Disease Activity Score (DAS) are means.
Danish: b Værdier for sygdomsaktivitetsscore (Disease Activity Score, DAS) er middelværdier.
English: Patient's name:
Danish: Patientens navn:
English: After the second click, count slowly to 15 to make sure that the injection is complete.
Danish: Når du hører det andet klik, tæller du langsomt til 15, så du er sikker på, at injektionen er færdig.
English: This is important to make the medicine easier and more comfortable to inject.
Danish: Dette er vigtigt, da det gør lægemidlet nemmere og mere komfortabelt at injicere.
English: These antibodies have generally been non-neutralising and transient.
Danish: Disse antistoffer har generelt været ikke-neutraliserende og er forbigående.
English: This appearance is normal for Benepali.
Danish: Dette udseende er normalt for Benepali.
English: Both TNFRs exist naturally in membrane-bound and soluble forms.
Danish: Begge TNFreceptorer eksisterer naturligt i membranbundne og opløselige former.
English: Benepali should only be used during pregnancy if clearly needed.
Danish: Benepali bør kun anvendes under graviditet, hvis det er absolut nødvendigt.
English: If you do not understand this information, please ask your doctor to explain it to you.
Danish: Hvis du ikke forstår disse oplysninger, skal du bede din læge om at forklare dem.
English: Results: ● Please ask your physician to list your other medicines that may increase your risk of infection.
Danish: Resultater: ● Bed din læge angive dine andre lægemidler, som kunne øge din risiko for infektion.
English: Baseline Week 52
Danish: Baseline Uge 52
English: The difference between etanercept alone and methotrexate alone was also significant (p < 0.05).
Danish: Forskellen mellem etanercept alene og methotrexat alene var også signifikant (p < 0,05).
English: Other etanercept products with appropriate dosage forms for children are available.
Danish: Der findes andre etanercept-produkter med passende doseringsformer til børn.
English: The osmolality of the solution is 325 ± 35 mOsm/kg.
Danish: Opløsningens osmolalitet er 325 ± 35 mOsm/kg.
English: Responses of patients with psoriasis in studies 2, 3 and 4
Danish: Respons hos patienter med psoriasis i studie 2, 3 og 4
English: a Patients who did not complete 12 months in the study were considered to be non-responders.
Danish: a Patienter, som ikke gennemførte 12 måneder af studiet, blev betragtet som ikke-responderende.
English: Dose proportionality has not been formally evaluated, but there is no apparent saturation of clearance across the dosing range.
Danish: Dosisproportionalitet er ikke blevet evalueret formelt, men der er ingen tilsyneladende mætning af clearance hen over dosisområdet.
English: The central volume of distribution of etanercept is 7.6 L, while the volume of distribution at steady-state is 10.4 L.
Danish: Den centrale distributionsvolumen for etanercept er 7,6 l, mens distributionsvolumen ved steady-state er 10,4 l.
English: 2616 LR Delft The Netherlands
Danish: 2616 LR Delft Holland
English: Treatment with Benepali should continue until remission is achieved, for up to 24 weeks.
Danish: Behandlingen med Benepali bør fortsættes indtil remission er nået, i op til 24 uger.
English: The following list of adverse reactions is based on experience from clinical trials in adults and on postmarketing experience.
Danish: Følgende liste over bivirkninger er baseret på erfaringer fra kliniske studier hos voksne og på postmarketing erfaring.
English: Patients were also required to have an inadequate response or intolerance to two or more NSAIDs.
Danish: Patienterne skulle desuden have utilstrækkeligt respons på eller være intolerante over for to eller flere NSAID'er.
English: Always have the outer carton of the medicine with you, even if it is empty.
Danish: Medbring altid medicinæsken, også selv om den er tom.
English: However, it cannot be excluded that the combination of etanercept with methotrexate could be associated with an increase in the rate of infections.
Danish: Det kan dog ikke udelukkes, at kombinationen etanercept og methotrexat kan være forbundet med en stigning i infektionsraten.
English: 36 months.
Danish: 36 måneder.
English: Simulation of dosing suggests that while older children (10-17 years of age) will have serum levels close to those seen in adults, younger children will have appreciably lower levels.
Danish: Dosissimulering antyder, at mens ældre børn (1017 år gamle) vil have serumniveauer tæt på dem, der ses hos voksne, vil yngre børn have væsentligt lavere niveauer.
English: The healthcare professional's educational material should contain the following key elements:
Danish: Undervisningsmaterialet til læger og andet sundhedspersonale skal indeholde oplysninger om følgende vigtige elementer:
English: Reports have included fatal and life-threatening infections and sepsis.
Danish: Rapporterne har omfattet letale og livstruende infektioner og sepsis.
English: Patients had previously been treated with NSAIDs (86%), DMARDs (80%), and corticosteroids (24%).
Danish: Patienterne var tidligere blevet behandlet med NSAID'er (86 %), DMARD'er (80 %) og kortikosteroider (24 %).
English: Mean (SE) annualized change from baseline in total sharp score Time
Danish: Middel (SE) ændring fra baseline i Total Sharp Score på årsbasis Tidspunkt
English: Administration of live vaccines to infants for 16 weeks after the mother's last dose of Benepali is generally not recommended.
Danish: Administration af levende vacciner til spædbørn inden for 16 uger efter moderens sidste Benepali-dosis må derfor almindeligvis frarådes.
English: ● Show this card to any doctor involved in your or your child's treatment.
Danish: ● Vis dette kort til læger, som er involveret i din eller dit barns behandling.
English: Check for the yellow plunger rod in the window to confirm that the full dose has been delivered.
Danish: Kontrollér det gule stempel i vinduet, for at bekræfte, at hele dosen er givet.
English: • Do not recycle.
Danish: • Må ikke genbruges.
English: However, any of the above symptoms may indicate an allergic reaction to Benepali, so you should seek immediate medical attention.
Danish: Hvilken som helst af ovennævnte symptomer kan dog tyde på en allergisk reaktion over for Benepali, og du skal derfor søge øjeblikkelig lægehjælp.
English: • Instructional materials to share with patients.
Danish: • Undervisningsmateriale til udlevering til patienter.
English: The results of this controlled trial were expressed in percentage improvement in rheumatoid arthritis using American College of Rheumatology (ACR) response criteria.
Danish: Resultaterne af dette kontrollerede studie blev angivet i procentvis forbedring af reumatoid artrit ved anvendelse af American College of Rheumatology's (ACR) kriterier for respons.
English: In addition, use of an immunoglobulin Fc region as a fusion element in the construction of a dimeric receptor imparts a longer serum half-life.
Danish: Derudover bibringer brugen af en immunglobulin Fc-region som et fusionselement i opbyggelsen af en dimerisk receptor en længere serum-halveringstid.
English: Sharps disposal containers may be purchased at your local pharmacy.
Danish: Kanyleboksene kan købes på dit lokale apotek.
English: Biogen (Denmark) Manufacturing ApS Biogen Allé 1 3400 Hillerød Denmark
Danish: Biogen (Denmark) Manufacturing ApS Biogen Allé 1 3400 Hillerød Danmark
English: Your doctor will determine the correct dose for the child and will prescribe an appropriate strength of etanercept.
Danish: Lægen vil beregne den rette dosis for barnet og ordinere en passende styrke af etanercept.
English: With twice-weekly doses, it is anticipated that steady-state concentrations are approximately twice as high as those observed after single doses.
Danish: Med to ugentlige doser forventes det, at steady-state koncentrationerne er ca. to gange så høje som dem, der observeres efter enkelte doser.
English: SE = standard error a p = 0.0001
Danish: SE = Standardfejl (Standard Error) a p = 0,0001
English: It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating etanercept therapy (see Vaccinations, above).
Danish: Det anbefales, at pædiatriske patienter om muligt bringes à jour med al immunisering i overensstemmelse med gældende retningslinjer for immunisering, før behandling med etanercept påbegyndes (se Vaccinationer ovenfor).
English: Some patients have developed a reaction at an injection site that was used before.
Danish: Nogle patienter har haft en reaktion på et injektionssted, som havde været brugt før.
English: Posology and administration are the same as for adults 18-64 years of age.
Danish: Dosering og administration er den samme som hos voksne på 1864 år.
English: A total of 401 patients were enrolled, from which 203 were treated with etanercept.
Danish: I alt 401 patienter blev inkluderet, af hvilke 203 blev behandlet med etanercept.
English: Long-term experience with etanercept was generally comparable to the original 48-week study and did not reveal any new safety findings.
Danish: Erfaringerne fra langtidsstudiet med etanercept var generelt sammenlignelige med det oprindelige 48-ugers studie og gav ingen nye sikkerhedsresultater.
English: The other cases represented a variety of different malignancies and included rare malignancies typically associated with immunosuppression.
Danish: De resterende tilfælde omfattede en række andre maligniteter, herunder sjældne maligniteter, der typisk bliver forbundet med immunsuppression.
English: • A needle-free demonstration device
Danish: • Et nålefrit demonstrationsprodukt
English: • Teaching guide to facilitate training of the patients in the safe use of the pre-filled pen/prefilled syringes
Danish: • Undervisningsvejledning til oplæring af patienter i sikker brug af den fyldte pen/de fyldte injektionssprøjter
English: A 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg.
Danish: Et hætteglas med 10 mg kan være bedre egnet til administration til børn med JIA, der vejer mindre end 25 kg.
English: Samsung BioLogics Co., Ltd. 300, Songdo bio-daero Yeonsu-gu, Incheon City, 21987, Korea, Republic of
Danish: Samsung BioLogics Co., Ltd. 300, Songdo bio-daero Yeonsu-gu, Incheon City, 21987, Republikken Korea
English: There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known pre-existing cardiovascular disease.
Danish: Der har også været sjældne (< 0,1 %) rapporter om nyopstået CHF, herunder CHF hos patienter uden kendt forudeksisterende hjerte-karsygdom.
English: Always use this medicine exactly as your doctor has told you.
Danish: Brug altid dette lægemiddel nøjagtigt efter lægens anvisning.
English: See ‘Choose an injection site' for guidance with choosing an injection site.
Danish: Se ”Vælg det sted, hvor du vil injicere” for vejledning i valg af injektionssted.
English: Serious infections affect fewer than 1 in 100 patients treated with etanercept.
Danish: Alvorlige infektioner ses hos færre end 1 ud af 100 patienter, der behandles med etanercept.
English: Inspect the solution in the pen by looking through the clear inspection window.
Danish: Kontrollér opløsningen i pennen ved at se gennem det gennemsigtige inspektionsvindue.
English: It is important that you tell the baby's doctors and other healthcare professionals about the use of Benepali during pregnancy before the baby receives any vaccine (for more information see section 2, “Vaccinations”).
Danish: Det er vigtigt, at du fortæller læger og andet sundhedspersonale, at du har taget Benepali under graviditeten, inden spædbarnet skal vaccineres (for mere information, se punkt 2 "Vaccinationer").
English: Benepali is also prescribed for the treatment of the following diseases in children and adolescents.
Danish: Benepali ordineres også til behandling af følgende sygdomme hos børn og unge:
English: • The risk of Congestive Heart Failure (CHF)
Danish: • Risikoen for kongestiv hjerteinsufficiens (CHF)
English: The dosage of etanercept is based on body weight for paediatric patients.
Danish: Doseringen af etanercept er baseret på legemsvægt for pædiatriske patienter.
English: • Swelling of the face, throat, hands, or feet
Danish: • Opsvulmen af ansigt, hals, hænder eller fødder.
English: Benepali may increase your risk of getting infections, which could be serious.
Danish: Benepali kan øge din risiko for at få infektioner, som kan være alvorlige.
English: • Vaccinations: If possible, children should be up to date with all vaccinations before using Benepali.
Danish: • Vaccinationer: Hvis det er muligt, skal børn være ajour med alle vaccinationer, før du får Benepali.
English: If an alternate dose is required, other etanercept products offering such an option should be used.
Danish: Hvis der er behov for en anden dosis, skal der anvendes andre etanercept-produkter, der giver mulighed for en sådan dosering.
English: Non-interactions
Danish: Ingen interaktioner
English: Responses observed during the open-label period were similar to those observed in the double-blind period.
Danish: Det observerede respons i den åbne studieperiode var det samme som det, der blev observeret i den dobbeltblindede periode.
English: If you are injecting into the abdomen, choose a site that is at least 5 cm away from the belly button.
Danish: Hvis du injicerer i maven, skal du vælge et sted, som ligger mindst 5 cm fra navlen.
English: After discontinuation of etanercept, symptoms of arthritis generally returned within a month.
Danish: Efter ophør med etanercept vendte symptomerne på artrit almindeligvis tilbage inden for en måned.
English: Two large clinical trials evaluating the use of etanercept in the treatment of CHF were terminated early due to lack of efficacy.
Danish: To store kliniske studier, der evaluerede brugen af etanercept i behandlingen af CHF, blev afsluttet før tiden på grund af manglende effektivitet.
English: • Do not try to give yourself the injection unless your doctor or nurse has shown you how to give the injection.
Danish: • Du må ikke selv injicere, medmindre din læge eller sygeplejerske har oplært dig i selvinjektion.
English: In some cases, particular fungal and other opportunistic infections have not been recognised, resulting in delay of appropriate treatment and sometimes death.
Danish: I visse tilfælde blev især svampeinfektioner og andre opportunistiske infektioner ikke diagnosticeret, hvilket resulterede i forsinket indsættelse af relevant behandling og i visse tilfælde død.
English: • moderate or severe psoriasis.
Danish: • moderat eller svær psoriasis.
English: ● You should not use Benepali if you have an infection.
Danish: ● Du må ikke bruge Benepali, hvis du har en infektion.
English: Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with etanercept use.
Danish: Centrale og perifere demyeliniserende hændelser er blevet set henholdsvis sjældent og meget sjældent i forbindelse med brug af etanercept.
English: Although not conclusive, data from one of these trials suggest a possible tendency toward worsening CHF in those patients assigned to etanercept treatment.
Danish: Selvom de ikke er endelige, antyder data fra ét af disse studier en mulig tendens til forværret CHF hos de patienter, der var tildelt etanerceptbehandlingen.
English: Patients receiving DMARDs, NSAIDS, or corticosteroids could continue them on stable doses.
Danish: Patienter i behandling med DMARD'er, NSAID'er eller kortikosteroider kunne fortsætte med disse på stabile doser.
English: Benepali treatment may increase mortality in patients with established sepsis.
Danish: Benepali-behandling kan forøge dødeligheden hos patienter med etableret sepsis.
English: Benepali works by reducing the inflammation associated with certain diseases.
Danish: Benepali virker ved at reducere inflammationen i forbindelse med visse sygdomme.
English: Dose and frequency of dosing for the child or adolescent will depend on body weight and disease.
Danish: Dosen og doseringshyppigheden til barnet eller den unge vil variere afhængigt af barnets vægt og sygdom.
English: When the syringe is empty, remove the needle from the skin at the same angle as inserted.
Danish: Når injektionssprøjten er tom, tager du kanylen ud af huden i samme vinkel, som den blev indført.
English: The device will click when the injection begins.
Danish: Pennen klikker, når injektionen begynder.
English: Benepali is a biosimilar medicinal product.
Danish: Benepali er et biosimilært lægemiddel.
English: Before starting treatment with Benepali, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Danish: Før behandling med Benepali påbegyndes, skal alle patienter undersøges for både aktiv og inaktiv (latent) tuberkulose.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, det vil sige det i det væsentlige er “natriumfrit”.
English: No data are available on the secondary transmission of infection by live vaccines in patients receiving etanercept.
Danish: Der er ingen data til rådighed om sekundær transmission af infektion via levende vacciner hos patienter, som får etanercept.
English: The impact of advanced age was studied in the population pharmacokinetic analysis of etanercept serum concentrations.
Danish: Indvirkning af fremskreden alder blev undersøgt i den farmakokinetiske populationsanalyse af etanercept-serumkoncentrationer.
English: • Do not use heat sources, such as a microwave or hot water, to warm Benepali.
Danish: • Du må ikke bruge varmekilder, som f.eks. en mikrobølgeovn eller varmt vand til at opvarme Benepali.
English: The specific activity of etanercept is 1.7 × 106 units/mg.
Danish: Etanercepts specifikke aktivitet er 1,7 x 106 enheder/mg.
English: If you received Benepali during pregnancy, your baby may have a higher risk of getting an infection.
Danish: Hvis du har taget Benepali under graviditet, kan dit spædbarn have en øget risiko for at få en infektion.
English: You or the child should not use Benepali with medicines that contain the active substance anakinra or abatacept.
Danish: Du eller barnet må ikke bruge Benepali samtidigt med andre lægemidler, som indeholder de aktive stoffer anakinra eller abatacept.
English: Doctor's name:
Danish: Lægens navn:
English: • if you or the child you are caring for, are allergic to etanercept or any of the other ingredients of Benepali (listed in section 6).
Danish: • hvis du eller dit barn er allergisk over for etanercept eller et af de øvrige indholdsstoffer i Benepali (angivet i punkt 6).
English: Alternatively, 50 mg administered once weekly has been shown to be safe and effective (see section 5.1).
Danish: Alternativt har 50 mg administreret én gang om ugen vist sig sikker og effektiv (se pkt.
English: In this study, structural joint damage was assessed radiographically and expressed as change in Total Sharp Score (TSS) and its components, the erosion score and Joint Space Narrowing (JSN) score.
Danish: I dette studie blev strukturel ledskade vurderet radiografisk og udtrykt som ændring i Total Sharp Score (TSS) og dets bestanddele, erosionsscore og score for forsnævring af ledspalter (JSN).
English: Read the instructions for use before you start using Benepali and each time you get a refill of your prescription.
Danish: Læs brugsanvisningen, inden du begynder at bruge Benepali, og hver gang du får fornyet din recept.
English: The safety and efficacy profiles of the two etanercept treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens.
Danish: Sikkerheds- og effektprofilerne af de to etanercept-behandlingsformer var sammenlignelige ved uge 8 med hensyn til effekten på tegn og symptomer på reumatoid artrit; data fra uge 16 viste ikke sammenlignelighed (non-inferioritet) mellem de to behandlingsformer.
English: At baseline, patients had a moderate degree of disability, with mean HAQ scores of 1.4 to 1.5.
Danish: Ved baseline havde patienterne en moderat grad af handicap, med en gennemsnitlig HAQ-score på 1,4 til 1,5.
English: There have been post-marketing reports of worsening of CHF, with and without identifiable precipitating factors, in patients taking etanercept.
Danish: Der har været postmarketingrapporter om forværring af CHF, med og uden identificerbare fremskyndende faktorer hos patienter, der tager etanercept.
English: The side effects and their frequencies seen in children and adolescents are similar to those described above.
Danish: Bivirkninger hos børn og unge svarer til dem, der er beskrevet ovenfor.
English: Patients should be evaluated for infections before, during, and after treatment with Benepali, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours).
Danish: Patienterne bør undersøges for infektioner før, under og efter behandling med Benepali, under hensyntagen til at middeleliminationshalveringstiden for etanercept er ca. 70 timer (fra 7 til 300 timer).
English: Patients also had plaque psoriasis with a qualifying target lesion ≥ 2 cm in diameter.
Danish: Patienterne havde også plaque psoriasis med en kvalificerende mållæsion på ≥ 2 cm i diameter.
English: These patients should be monitored for signs and symptoms of active HBV infection throughout therapy and for several weeks following termination of therapy.
Danish: Disse patienter bør monitoreres for tegn og symptomer på aktiv HBVinfektion gennem hele behandlingsforløbet og i flere uger efter, at behandlingen er afsluttet.
English: Contents of the pack and other information Instructions for use (see overleaf)
Danish: Pakningsstørrelser og yderligere oplysninger Brugsanvisning (se næste side)
English: Allow the medicine to reach room temperature:
Danish: Lad lægemidlet opnå stuetemperatur:
English: In placebo-controlled trials, no increase in the incidence of serious infections (fatal, life-threatening, or requiring hospitalisation or intravenous antibiotics) was observed.
Danish: I placebo-kontrollerede studier blev der ikke observeret nogen stigning i forekomsten af alvorlige infektioner (dødelige, livstruende, eller som kræver hospitalsindlæggelse eller intravenøs antibiotikabehandling).
English: The observed rates and incidences in these clinical trials were similar to those expected for the population studied.
Danish: De observerede tal og forekomster i disse kliniske studier svarede til dem, der forventedes for den behandlede gruppe.
English: The combination etanercept and anakinra has not demonstrated increased clinical benefit, and is therefore not recommended.
Danish: Kombinationen af etanercept og anakinra har ikke vist øgede kliniske fordele og frarådes derfor.
English: Benepali is a medicine that is made from two human proteins.
Danish: Benepali er et lægemiddel fremstillet af to proteiner, som findes naturligt hos mennesker.
English: Slowly push down the plunger to inject all of the Benepali solution.
Danish: Skub langsomt stemplet i bund for at injicere hele Benepali-opløsningen.