FrancophonIA/ELRC3.0 huggingface dataset:
English: The right dose for you will depend on your body weight at the time each dose is given.
Danish: Den rigtige dosis til dig afhænger af din kropsvægt på det tidspunkt, hvor den enkelte dosis gives.
English: Chemical and physical in-use stability has been demonstrated for 8 hours at 15-25°C.
Danish: Der er påvist kemisk og fysisk stabilitet i 8 timer ved 15 til 25 °C under brug.
English: If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it.
Danish: Hvis din læge mener, at du har risiko for at få tuberkulose, kan du få medicin til at behandle det.
English: Adolescent patients (12-17 years)
Danish: Unge patienter (12-17 år)
English: • There may be a small amount of blood or liquid at the injection site.
Danish: • Der kan være en lille smule blod eller væske på injektionsstedet.
English: Patients in these studies had a diagnosis of PsA for at least 6 months.
Danish: Patienterne i disse studier havde været diagnosticeret med PsA i mindst 6 måneder.
English: CDLQI of 0 or 1 indicates no effect on child's quality of life.
Danish: CDLQI 0 eller 1 indikerer, at der ikke er nogen indvirkning på barnets livskvalitet.
English: In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Danish: For at øge sporbarheden af biologiske lægemidler skal det administrerede produkts handelsnavn og batchnummer registreres tydeligt.
English: Also tell your doctor if you have recently been near anyone who might have tuberculosis.
Danish: Kontakt også lægen, hvis du for nylig har været i nærheden af en person, der kunne have tuberkulose.
English: Efficacy data were collected and analyzed through week 8 for both studies.
Danish: Effektdata blev indsamlet og analyseret til og med uge 8 i begge studier.
English: Before administration, STELARA should be allowed to reach room temperature (approximately half an hour).
Danish: Før administration skal STELARA have lov til at stå for at få stuetemperatur (ca. en halv time).
English: The safety profiles of the recommended dose and half of the recommended dose were comparable.
Danish: Sikkerhedsprofilerne for den anbefalede dosis og halvdelen af den anbefalede dosis var sammenlignelige.
English: The basis for this analysis was that at least 100 patients (> 5% of the studied population) were treated concomitantly with these medicinal products for at least 90% of the study period.
Danish: Grundlaget for denne analyse var, at mindst 100 patienter (> 5% af den undersøgte population) blev behandlet samtidigt med disse lægemidler i mindst 90% af studieperioden.
English: • It is important that the needle is always in the liquid.
Danish: • Det er vigtigt, at nålen hele tiden befinder sig i væsken.
English: Single dose versus multiple doses
Danish: Enkeltdosis versus flere doser
English: Your doctor will decide when you should receive your next dose.
Danish: Din læge beslutter, hvornår du skal have din næste dosis.
English: • If you are 65 years of age or over - you may be more likely to get infections.
Danish: • Hvis du er over 65 år - i så fald kan du være mere tilbøjelig til at få infektioner.
English: Most were considered to be mild and did not necessitate discontinuation of study treatment.
Danish: De fleste blev anset for at være milde og nødvendiggjorde ikke seponering af forsøgsmedicinen.
English: There are no adequate data from the use of ustekinumab in pregnant women.
Danish: Der findes ikke tilstrækkelige data om brugen af ustekinumab hos gravide kvinder.
English: Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.
Danish: Eftersom der generelt er højere incidens af infektioner hos den ældre befolkning, bør der udvises forsigtighed ved behandling af ældre patienter.
English: Improvement has been reported after discontinuation of ustekinumab and also, in some cases, administration of corticosteroids.
Danish: Der er indberettet forbedring efter seponering af ustekinumab og desuden i visse tilfælde ved administration af kortikosteroider.
English: You may cover the injection site with a small adhesive bandage, if necessary.
Danish: Du kan dække injektionsstedet med et lille plaster, hvis det er nødvendigt.
English: This leaflet has been written for the person taking the medicine.
Danish: Denne indlægsseddel er skrevet til den person, der tager medicinen.
English: The first study was in 110 patients from 12 to 17 years of age treated for up to 60 weeks and the second study was in 44 patients from 6 to 11 years of age treated for up to 56 weeks.
Danish: Det første studie var med 110 patienter mellem 12 og 17 år, som blev behandlet i op til 60 uger, og det andet studie var med 44 patienter mellem 6 og 11 år, som blev behandlet i op til 56 uger.
English: This effect was driven by PsA Study 1.
Danish: Denne virkning sås især i PsA-studie 1.
English: Stelara will reduce the inflammation and other signs of the disease.
Danish: Stelara mindsker inflammationen og andre tegn på sygdommen.
English: If these symptoms occur, appropriate therapy should be instituted.
Danish: Hvis disse symptomer opstår, skal passende behandling indledes.
English: However, if you stop, your symptoms may come back.
Danish: Hvis du stopper behandlingen, kan dine symptomer dog komme tilbage.
English: Volume of injection (mL)
Danish: Injektionsvolumen (ml)
English: Approximately 50% of patients continued on stable doses of MTX (≤ 25 mg/week).
Danish: Ca. 50% af patienterne fortsatte med stabile doser af MTX (≤ 25 mg/uge).
English: The final volume in the infusion bag should be 250 mL.
Danish: Det endelige volumen i infusionsposen skal være 250 ml.
English: No new safety concerns were identified in this study extension with up to 2 years of treatment in patients with Crohn's Disease.
Danish: Der blev ikke identificeret nye problemer med sikkerheden i denne forlængelse af studiet med op til 2 års behandling af patienter med Crohns sygdom.
English: Tell your doctor if you have any kind of infection that will not go away or keeps coming back.
Danish: Fortæl det til lægen, hvis du får en infektion, der ikke vil gå væk eller bliver ved med at vende tilbage.
English: Serious outcomes have included respiratory failure and prolonged hospitalisation.
Danish: Alvorlige udfald har blandt andet omfattet respiratorisk insufficiens og længerevarende hospitalsindlæggelse.
English: Efficacy results presented for UNIFI-I and UNIFI-M were based on central review of endoscopies.
Danish: Effektresultaterne, der blev præsenteret for UNIFI-I og UNIFI-M, var baseret på central gennemgang af endoskopier.
English: Uncommon: Depression
Danish: Ikke almindelig: Depression
English: Antibodies to ustekinumab may develop during ustekinumab treatment and most are neutralising.
Danish: Der kan udvikles antistoffer mod ustekinumab under behandling med ustekinumab, og de fleste er neutraliserende.
English: Anaphylaxis and angioedema have occurred.
Danish: Tilfælde af anafylaksi og angioødem er forekommet.
English: Do not touch the plunger while you do this
Danish: Rør ikke ved stemplet, mens du gør det.
English: The container of this medicinal product contains latex rubber.
Danish: Beholderen til dette lægemiddel indeholder latex gummi.
English: • If you ever had an allergic reaction to Stelara.
Danish: • Hvis du nogensinde har haft en allergisk reaktion på Stelara.
English: Radiographic Response
Danish: Radiografisk respons
English: After the injection:
Danish: Efter injektionen:
English: Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy.
Danish: Immunsuppressiva som ustekinumab har et potentiale for at øge risikoen for maligniteter.
English: A pre-specified integrated analysis combining data from 927 subjects in both PsA Study 1 and 2 was performed.
Danish: Der blev udført en på forhånd fastsat integreret analyse, der omfattede data fra 927 forsøgspersoner i både PsA-studie 1 og 2.
English: Clinical Remission, week 8
Danish: Klinisk remission, uge 8
English: Patients receiving STELARA should be monitored closely for signs and symptoms of active tuberculosis during and after treatment.
Danish: Patienter, der får STELARA, skal monitoreres nøje med henblik på tegn og symptomer på aktiv tuberkulose under og efter behandlingen.
English: Patients with a CDLQI > 1 at baseline
Danish: Patienter med CDLQI > 1 ved baseline
English: Endoscopic Normalization
Danish: Endoskopisk normalisering
English: • Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Danish: • Tal med din læge, hvis du er gravid, har mistanke om, at du er gravid eller planlægger at blive gravid.
English: The improvement was sustained through week 28.
Danish: Forbedringen blev opretholdt til og med uge 28.
English: In PsA Study 1 (PSUMMIT I) and PsA Study 2 (PSUMMIT II), 80% and 86% of the patients, respectively, had been previously treated with DMARDs.
Danish: I PsA-studie 1 (PSUMMIT I) og PsA-studie 2 (PSUMMIT II) var henholdsvis 80% og 86% af patienterne tidligere blevet behandlet med DMARD.
English: If you have a serious allergic reaction, your doctor may decide that you should not use Stelara again.
Danish: Hvis du får en alvorlig allergisk reaktion, vil lægen måske beslutte, at du ikke må få Stelara igen.
English: • Stelara 130 mg concentrate for solution for infusion is given in a hospital or clinic and patients should not need to store or handle it.
Danish: • Stelara 130 mg koncentrat til infusionsvæske gives på et hospital eller en klinik, og patienterne skal ikke opbevare eller håndtere det.
English: Serious side effects Some patients may have serious side effects that may need urgent treatment.
Danish: Alvorlige bivirkninger Nogle patienter kan få alvorlige bivirkninger, der kan kræve omgående behandling.
English: Improvement in health-related quality of life was generally maintained during the extension through week 92.
Danish: Forbedringer i helbredsrelateret livskvalitet blev generelt opretholdt under forlængelsen til og med uge 92.
English: However it is possible it may increase the chance of diseases related to a weaker immune system.
Danish: Det er muligt, at det øger risikoen for sygdomme, der forbindes med et svækket immunsystem.
English: Single doses up to 6 mg/kg have been administered intravenously in clinical studies without dose-limiting toxicity.
Danish: Enkeltdoser på op til 6 mg/kg er blevet indgivet intravenøst i kliniske studier uden dosisbegrænsende toksicitet.
English: • it has not passed its expiry date
Danish: • at den ikke har overskredet udløbsdatoen
English: The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er opstillet i henhold til systemorganklasse og hyppighed i henhold til følgende konvention: Meget almindelig (≥ 1/10), Almindelig (≥ 1/100 til < 1/10), Ikke almindelig (≥ 1/1.000 til < 1/100), Sjælden (≥ 1/10.000 til < 1/1.000), Meget sjælden (< 1/10.000), Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: No specific studies have been conducted in elderly patients.
Danish: Der er ikke udført specifikke studier af ældre patienter.
English: Respiratory
Danish: Respiratoriske
English: STELARA should be discontinued if a drug reaction is suspected.
Danish: STELARA skal seponeres, hvis der er mistanke om en lægemiddelrelateret reaktion.
English: The induction studies included 1409 (UNITI-1, n = 769; UNITI-2 n = 640) patients.
Danish: Induktionsstudierne omfattede 1.409 (UNITI-1, n = 769; UNITI-2 n = 640) patienter.
English: • Do not rub the skin at the injection site.
Danish: • Gnid ikke huden på injektionsstedet.
English: There is no apparent correlation between the presence of anti-ustekinumab antibodies and the occurrence of injection site reactions.
Danish: Der er ingen åbenbar forbindelse mellem tilstedeværelse af antistoffer mod ustekinumab og forekomsten af reaktioner på injektionsstedet.
English: Over 70% and 40% of the patients in both studies had enthesitis and dactylitis at baseline, respectively.
Danish: Over 70% og 40% af patienterne i begge studier havde henholdsvis enthesitis og dactylitis ved baseline.
English: Prescribers should consult the Summary of Product Characteristics for the specific vaccine for additional information and guidance on concomitant use of immunosuppressive agents post-vaccination.
Danish: Receptudstedere bør konsultere produktresuméet for den specifikke vaccine for yderligere oplysninger og vejledning om samtidig brug af immunsuppressiva efter vaccination.
English: Latex sensitivity
Danish: Latex-overfølsomhed
English: PedsQL: The PedsQL Total Scale Score is a general health-related quality of life measure developed for use in children and adolescent populations.
Danish: PedsQL: PedsQL Total Scale Score er et generelt mål for helbredsrelateret livskvalitet, som er udviklet til brug hos børn og unge.
English: Do not take a double dose to make up for a forgotten dose.
Danish: Tag aldrig en dobbelt dosis, hvis du har glemt en dosis.
English: CDLQI: The CDLQI is a dermatology instrument to assess the effect of a skin problem on the health-related quality of life in the paediatric population.
Danish: CDLQI: CDLQI er et dermatologisk redskab til vurdering af et hudproblems indvirkning på den helbredsrelaterede livskvalitet i den pædiatriske population.
English: Treatment of latent tuberculosis infection should be initiated prior to administering STELARA.
Danish: Behandling af latent tuberkuloseinfektion skal påbegyndes før administration af STELARA.
English: Immunomodulators and/or corticosteroids may be continued during treatment with STELARA.
Danish: Behandling med immunmodulatorer og/eller kortikosteroider kan fortsættes under behandling med STELARA.
English: Stelara belongs to a group of medicines called ‘immunosuppressants'.
Danish: Stelara tilhører en gruppe lægemidler, der kaldes immunsuppressiva.
English: PGA = Physician Global Assessment
Danish: PGA = Lægens samlede vurdering.
English: After this, dosing every 12 weeks is recommended.
Danish: Derefter anbefales dosering hver 12. uge.
English: If this happens, you will get training on how to inject Stelara.
Danish: Hvis dette er tilfældet, vil du få undervisning i, hvordan du injicerer Stelara.
English: For the placebo group at week 12, N = 36 p = 0.028
Danish: I placebogruppen i uge 12, N = 36 p = 0,028
English: PASI 75 responders PASI 90 responders PASI 100 responders CDLQI
Danish: PASI 75 respondere PASI 90 respondere PASI 100 respondere CDLQI
English: STELARA should be administered at Weeks 0 and 4, then every 12 weeks thereafter.
Danish: STELARA skal administreres i uge 0 og 4 og derefter hver 12. uge.
English: • The active substance is ustekinumab.
Danish: • Aktivt stof: Ustekinumab.
English: However, the physician should ensure appropriate follow-up of patients.
Danish: Lægen skal dog sikre sig, at der sker den nødvendige opfølgning.
English: Serious hypersensitivity reactions have been reported in the postmarketing setting, in some cases several days after treatment.
Danish: Efter markedsføringen er der indberettet alvorlige overfølsomhedsreaktioner, som i nogle tilfælde er indtruffet flere dage efter behandlingen.
English: Talk to your doctor if you have any questions about giving yourself an injection.
Danish: Tal med din læge, hvis du har spørgsmål i forbindelse med at give dig selv en injektion.
English: No data are available on the secondary transmission of infection by live vaccines in patients receiving STELARA.
Danish: Der foreligger ikke data om sekundær transmission af infektion fra levende vacciner hos patienter, som fik STELARA.
English: • Do not mix Stelara with other liquids for injection
Danish: • Bland ikke Stelara med andre væsker til injektion
English: The calculated volume should be rounded to the nearest 0.01 mL and administered using a 1 mL graduated syringe.
Danish: Det beregnede volumen skal afrundes til nærmeste 0,01 ml og administreres med en gradueret 1 ml sprøjte.
English: Prepare the injection site
Danish: Forbered injektionsstedet
English: Never re-use a syringe, for your safety and health and for the safety of others.
Danish: Genbrug aldrig en sprøjte for din sikkerheds og dit helbreds skyld og af hensyn til andres sikkerhed.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyrestudier viser ikke direkte eller indirekte skadelige virkninger på graviditeten, den embryonale/føtale udvikling, fødslen eller den postnatale udvikling (se pkt.
English: Your doctor will examine you and do a test for tuberculosis, before you have Stelara.
Danish: Lægen vil så undersøge dig og teste dig for tuberkulose, før du får Stelara.
English: • If you are having any other treatment for psoriasis and/or psoriatic arthritis - such as another immunosuppressant or phototherapy (when your body is treated with a type of ultraviolet (UV) light).
Danish: • Hvis du får anden behandling for psoriasis og/eller psoriasisartrit - såsom et andet immunsuppressivum eller lysbehandling (når kroppen behandles med en type ultraviolet (UV) lys).
English: • If someone will assist in giving you the injection, then he or she may also choose the upper arms as an injection site.
Danish: • Hvis der er en, der vil hjælpe med at give dig injektionen, kan han eller hun også vælge overarmene som injektionssted.
English: Use a new needle and syringe for each injection.
Danish: Brug en ny nål og en ny sprøjte til hver injektion.
English: Non-clinical data reveal no special hazard (e.g. organ toxicity) for humans based on studies of repeated-dose toxicity and developmental and reproductive toxicity, including safety pharmacology evaluations.
Danish: Non-kliniske data viser ingen speciel risiko (f.eks. organtoksicitet) for mennesker vurderet ud fra studier af toksicitet efter gentagne doser samt reproduktions- og udviklingstoksicitet, herunder sikkerhedsfarmakologi.
English: The key efficacy results are shown in Table 6 below.
Danish: Hovedresultaterne for effekt fremgår af tabel 6 nedenfor.
English: At the start of treatment, your healthcare provider will assist you with your first injection.
Danish: Når behandlingen påbegyndes, vil din læge eller sygeplejerske hjælpe dig med den første injektion (indsprøjtning).
English: • warm, red and painful skin, or a painful skin rash with blisters
Danish: • varm, rød eller smertefuld hud eller et smertefuldt udslæt med blærer
English: Stelara is for single use only.
Danish: Stelara er kun til engangsbrug.
English: The recommended dose of STELARA based on body weight is shown below (Tables 1 and 2).
Danish: Den anbefalede dosis af STELARA baseret på kropsvægt er vist nedenfor (tabel 1 og 2).
English: Concomitant use of immunomodulators did not have a significant impact on ustekinumab disposition.
Danish: Samtidig brug af immunmodulatorer havde ikke nogen signifikant indvirkning på ustekinumabs fordeling.
English: Do not use Stelara:
Danish: Brug ikke Stelara:
English: In IM-UNITI, patients who completed the study through week 44 were eligible to continue treatment in a study extension.
Danish: I IM-UNITI kunne de patienter, som havde gennemført studiet til og med uge 44, fortsætte behandlingen i en forlængelse af studiet.
English: Before live viral or live bacterial vaccination, treatment with STELARA should be withheld for at least 15 weeks after the last dose and can be resumed at least 2 weeks after vaccination.
Danish: Før vaccination med levende vira eller levende bakterier skal behandling med STELARA suspenderes i mindst 15 uger efter den sidste dosis og kan tidligst genoptages 2 uger efter vaccinationen.
English: • If the seal is broken.
Danish: • hvis forseglingen er brudt.
English: There were no indications of an interaction with these concomitantly administered medicinal products.
Danish: Der var ingen indikation af interaktion ved samtidig administration at disse lægemidler.
English: Also tell your doctor if you have any open cuts or sores as they might get infected.
Danish: Fortæl også din læge, hvis du har åbne rifter eller sår, da der kan gå betændelse i dem.
English: To calculate the volume of injection (mL) for patients < 60 kg, use the following formula: body weight (kg) x 0.0083 (mL/kg) or see Table 2.
Danish: For at beregne injektionsvolumen (ml) for patienter < 60 kg skal følgende formel anvendes: kropsvægt (kg) x 0,0083 (ml/kg), se også tabel 2.
English: Tell your doctor right away if you develop symptoms such as cough, shortness of breath, and fever.
Danish: Kontakt straks lægen, hvis du får symptomer som for eksempel hoste, åndenød og feber.
English: These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications.
Danish: De kan være tegn på infektioner som brystinfektioner, hudinfektioner eller helvedesild, som kan medføre alvorlige komplikationer.
English: The proportion of patients with a PGA score of cleared (0) or minimal (1) at week 12 was 77.3%.
Danish: Andelen af patienter med en PGA-score på clear (0) eller minimal (1) i uge 12 var 77,3%.
English: Your doctor may decide that you should not use Stelara until the infection goes away.
Danish: Din læge kan beslutte, at du ikke må få Stelara, før infektionen er væk.
English: Stelara can cause serious side effects, including allergic reactions and infections.
Danish: Stelara kan give alvorlige bivirkninger, der kan omfatte allergiske reaktioner og infektioner.
English: Turnhoutseweg 30 2340 Beerse Belgium
Danish: Turnhoutseweg 30 2340 Beerse Belgien
English: Fertility The effect of ustekinumab on human fertility has not been evaluated (see section 5.3).
Danish: Fertilitet Ustekinumabs virkning på human fertilitet er ikke blevet evalueret (se pkt.
English: Infections - these may need urgent treatment.
Danish: Infektioner - kan kræve omgående behandling.
English: These treatments may also weaken part of the immune system.
Danish: Disse behandlinger kan også svække dele af immunsystemet.
English: The primary endpoint in these studies was the proportion of patients who achieved PASI 75 response from baseline at week 12 (see Tables 4 and 5).
Danish: Det primære effektmål i disse studier var andelen af patienter, der opnåede PASI 75 respons i forhold til baseline i uge 12 (se tabel 4 og 5).
English: Women of childbearing potential should use effective methods of contraception during treatment and for at least 15 weeks after treatment.
Danish: Kvinder i den fertile alder skal anvende effektive præventionsmetoder under behandlingen og i mindst 15 uger efter behandlingen.
English: In patients who have responded to treatment with STELARA, corticosteroids may be reduced or discontinued in accordance with standard of care.
Danish: Hos patienter, som har responderet på behandling med STELARA, kan behandling med kortikosteroider reduceres eller seponeres i henhold til standardbehandling.
English: • Store in a refrigerator (2°C-8°C).
Danish: • Opbevares i køleskab (2 °C - 8 °C).
English: Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).
Danish: Anvend kun et infusionssæt med et in-line sterilt, pyrogenfrit filter med minimal proteinbinding (porestørrelse 0,2 mikrometer).
English: Patients or their caregivers should be instructed to inject the prescribed amount of STELARA according to the directions provided in the package leaflet.
Danish: Patienterne eller deres omsorgspersoner skal have besked på at injicere den ordinerede mængde af STELARA i henhold til anvisningerne i indlægssedlen.
English: Allergic reactions - these may need urgent treatment.
Danish: Allergiske reaktioner - kan kræve omgående behandling.
English: STELARA treatment is to be initiated with a single intravenous dose based on body weight.
Danish: Behandling med STELARA skal påbegyndes med en enkelt intravenøs dosis baseret på kropsvægt.