FrancophonIA/ELRC3.0 huggingface dataset:
English: Thus, caution should be exercised when considering the use of STELARA in these patients.
Danish: Der skal derfor udvises forsigtighed, når det overvejes at give STELARA til disse patienter.
English: Etanercept 24 doses (50 mg twice a week)
Danish: Etanercept 24 doser (50 mg 2 gange ugentlig)
English: The solution may contain a few small translucent or white particles of protein.
Danish: Opløsningen kan indeholde enkelte små gennemsigtige eller hvide proteinpartikler.
English: STELARA does not contain preservatives; therefore any unused medicinal product remaining in the vial and the syringe should not be used.
Danish: STELARA indeholder ikke konserveringsmidler; derfor må ikke anvendt lægemiddel, der er tilbage i hætteglasset og sprøjten, ikke anvendes.
English: • If possible, do not use areas of skin that show signs of psoriasis
Danish: • Hvis det er muligt, skal du undgå at bruge hudområder med tegn på psoriasis.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
Danish: I tilfælde af overdosering anbefales det, at patienten monitoreres med henblik på tegn eller symptomer på bivirkninger, og at passende symptomatisk behandling iværksættes øjeblikkeligt.
English: Biotransformation The exact metabolic pathway for ustekinumab is unknown.
Danish: Biotransformation Den eksakte metaboliske omsætning af ustekinumab kendes ikke.
English: In Study 1 previous treatment with anti-tumour necrosis factor (TNF)α agent was not allowed.
Danish: I Studie 1 var tidligere behandling med midler mod tumornekrosefaktor (TNF)alfa ikke tilladt.
English: Anti-tuberculosis therapy should also be considered prior to initiation of STELARA in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Danish: Antituberkuløs behandling skal også overvejes, inden behandling med STELARA påbegyndes til patienter med latent eller aktiv tuberkulose, hvor et tidligere adækvat behandlingsforløb ikke kan bekræftes.
English: Choose an injection site (see Figure 2)
Danish: Vælg et injektionssted (se figur 2).
English: • Good places for the injection are the upper thigh or around the belly (abdomen) at least 5 cm away from the navel (belly button)
Danish: • Gode steder til injektionen er øverste del af låret eller omkring maven (abdomen) mindst 5 cm fra navlen.
English: Elderly (≥ 65 years) No dose adjustment is needed for elderly patients (see section 4.4).
Danish: Ældre (≥ 65 år) Dosisjustering hos ældre patienter er ikke nødvendig (se pkt.
English: • If you are having or have ever had injections to treat allergies - it is not known if Stelara may affect these.
Danish: • Hvis du får eller tidligere har fået injektionsbehandling mod allergi - det vides ikke, om Stelara kan påvirke disse behandlinger.
English: Never re-use needles and syringes, for your safety and health, and for the safety of others.
Danish: Genbrug aldrig nåle og sprøjter for din sikkerheds og dit helbreds skyld og af hensyn til andres sikkerhed.
English: The syringe is fitted with a passive safety guard.
Danish: Sprøjten er forsynet med en passiv sikkerhedsanordning.
English: Similar results were seen with each dose of ustekinumab.
Danish: Lignende resultater blev observeret for begge doser af ustekinumab.
English: The absolute bioavailability of ustekinumab following a single subcutaneous administration was estimated to be 57.2% in patients with psoriasis.
Danish: Den absolutte biotilgængelighed af ustekinumab efter en enkelt subkutan administration blev estimeret til 57,2% hos patienter med psoriasis.
English: 70 Point Response, week 3
Danish: 70-point-respons, uge 3
English: Traceability:
Danish: Sporbarhed:
English: • The recommended starting dose is 45 mg Stelara.
Danish: • Den anbefalede startdosis er 45 mg Stelara.
English: Let the vial stand for about half an hour.
Danish: Lad hætteglasset stå i ca. ½ time.
English: Specific studies have not been conducted in patients who had recently received live viral or live bacterial vaccines.
Danish: Der er ikke udført specifikke studier af patienter, der for nylig var blevet vaccineret med levende vira eller levende bakterier.
English: Adults aged 18 years or older
Danish: Voksne på 18 år og derover
English: Infusion dose of ustekinumab using the weight-based dosage regimen specified in Table 1.
Danish: Infusionsdosis af ustekinumab ved anvendelse af det vægtbaserede doseringsregime, der er specificeret i tabel 1.
English: Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections.
Danish: Ustekinumab kan øge risikoen for infektioner samt reaktivere latente infektioner.
English: The results of an in vitro study do not suggest the need for dose adjustments in patients who are receiving concomitant CYP450 substrates (see section 5.2).
Danish: Resultaterne af et in vitro-studie tyder ikke på, at dosisjustering er nødvendig hos patienter, som er i samtidig behandling med CYP450-substrater (se pkt.
English: Signs include: o difficulty breathing or swallowing o low blood pressure, which can cause dizziness or light-headedness o swelling of the face, lips, mouth or throat.
Danish: Tegnene omfatter: o besvær med at trække vejret eller synke o lavt blodtryk, som kan give svimmelhed eller omtågethed o hævelser i ansigt, læber, mund eller svælg.
English: Similarly, significant improvements were seen in Psoriasis Study 2 at week 4 and 12, which were sustained through week 24.
Danish: Lignende signifikante forbedringer blev set i psoriasisstudie 2 i uge 4 og 12, som blev opretholdt til og med uge 24.
English: If you do not respond well enough or are intolerant to these medicines, you may be given Stelara to reduce the signs and symptoms of your disease.
Danish: Hvis du ikke reagerer godt nok på disse lægemidler, eller hvis du ikke kan tåle dem, kan du få Stelara for at reducere symptomerne på din sygdom.
English: Clinically important, active infection (e.g. active tuberculosis; see section 4.4).
Danish: Klinisk vigtig, aktiv infektion (f.eks. aktiv tuberkulose; se pkt.
English: Impact of weight on pharmacokinetics
Danish: Indvirkning af vægt på farmakokinetik
English: If a patient develops a serious infection, the patient should be closely monitored and STELARA should not be administered until the infection resolves.
Danish: En patient, der udvikler en alvorlig infektion, skal monitoreres nøje, og STELARA må ikke indgives, før infektionen har fortaget sig.
English: CDLQI of 0 or 1 PedsQL
Danish: CDLQI 0 eller 1 PedsQL
English: The majority of patients who lost response and resumed ustekinumab did so within 24 weeks of the induction infusion.
Danish: Størstedelen af de patienter, som ophørte med at respondere og genoptog behandlingen med ustekinumab, gjorde dette inden for 24 uger efter induktionsinfusionen.
English: • If you have any new or changing lesions within psoriasis areas or on normal skin.
Danish: • Hvis du har fået nye skader i huden eller forandringer i områder med psoriasis eller på normal hud.
English: It is unknown whether ustekinumab is excreted in human breast milk.
Danish: Det er ukendt, om ustekinumab udskilles i human mælk.
English: In general, the adverse events reported in these two studies with safety data up to 1 year were similar to those seen in previous studies in adults with plaque psoriasis.
Danish: Generelt svarede de indberettede bivirkninger i disse to studier med sikkerhedsdata i op til 1 år til de bivirkninger, der observeredes i tidligere studier hos voksne med plaque-psoriasis.
English: The most frequently observed malignancies, other than non-melanoma skin cancer, were prostate, colorectal, melanoma and breast cancers.
Danish: De hyppigst observerede maligniteter, når der ses bort fra ikke-melanom hudkræft, var prostatakræft, kolorektal kræft, melanom og brystkræft.
English: Patients who have not shown adequate response at 8 weeks after the first subcutaneous dose, may receive a second subcutaneous dose at this time (see section 5.1).
Danish: Patienter, som ikke udviser et tilstrækkeligt respons 8 uger efter den første subkutane dosis, kan gives endnu en subkutan dosis på dette tidspunkt (se pkt.
English: Steady state ustekinumab concentration was achieved by the start of the second maintenance dose.
Danish: Steady state-koncentration af ustekinumab blev nået lige inden den anden vedligeholdelsesdosis.
English: Loss of response was defined as a CDAI score ≥ 220 points and a ≥ 100 point increase from the CDAI score at baseline.
Danish: Tab af respons blev defineret som CDAI-score ≥ 220 point og en stigning på ≥ 100 point i forhold til CDAI-score ved baseline.
English: Patients with PASI ≥ 12, PGA ≥ 3 and BSA involvement of at least 10%, who were candidates for systemic therapy or phototherapy, were eligible for the study.
Danish: Patienter med PASI ≥ 12, PGA ≥ 3 og BSA-påvirkning på mindst 10%, som var kandidater til systemisk behandling eller lysbehandling, kunne deltage i studiet.
English: Prior to initiating treatment with STELARA, patients should be evaluated for tuberculosis infection.
Danish: Inden behandling med STELARA påbegyndes, skal patienterne vurderes med hensyn til tuberkulose.
English: The incidence of malignancies reported in ustekinumab-treated patients was comparable to the incidence expected in the general population (standardised incidence ratio = 0.93 [95% confidence interval: 0.71, 1.20], adjusted for age, gender and race).
Danish: Den rapporterede forekomst af maligniteter hos patienter, der blev behandlet med ustekinumab, var sammenlignelig med den forventede forekomst hos befolkningen generelt (standardiseret incidensrate = 0,93 [95% konfidensinterval: 0,71-1,20]) justeret for alder, køn og race.
English: Alternatively, 90 mg may be used in patients with a body weight > 100 kg.
Danish: Alternativt kan der gives 90 mg til patienter med en legemsvægt > 100 kg.
English: It is not known if ustekinumab is absorbed systemically after ingestion.
Danish: Det vides ikke, om ustekinumab absorberes systemisk efter oral indtagelse.
English: In a population pharmacokinetic analysis, the apparent clearance (CL/F) and apparent volume of distribution (V/F) were 0.465 l/day and 15.7 l, respectively, in patients with psoriasis.
Danish: I en farmakokinetisk populationsanalyse var den tilsyneladende clearance (CL/F) og det tilsyneladende fordelingsvolumen (V/F) henholdsvis 0,465 l/dag og 15,7 l hos patienter med psoriasis.
English: Children weighing less than 60 kg need a dose lower than 45 mg. Make sure you know the proper amount (volume) to remove from the vial and type of syringe needed for dosing.
Danish: Børn, der vejer under 60 kg, skal have en dosis under 45 mg. Sørg for at vide, hvor stor en mængde (hvor stort et volumen) der skal fjernes fra hætteglasset, og hvilken type sprøjte der skal bruges til dosering.
English: 70 Point Response, week 6
Danish: 70-point-respons, uge 6
English: No specific studies have been conducted with intravenous ustekinumab in elderly or paediatric patients.
Danish: Der er ikke udført specifikke studier med intravenøs ustekinumab hos ældre eller pædiatriske patienter.
English: STELARA has no or negligible influence on the ability to drive and use machines.
Danish: STELARA har ingen eller kun ubetydelig virkning på evnen til at føre motorkøretøj og betjene maskiner.
English: Cases of allergic alveolitis, eosinophilic pneumonia, and non-infectious organising pneumonia have been reported during post-approval use of ustekinumab.
Danish: Der er indberettet tilfælde af allergisk alveolitis, eosinofil pneumoni og ikke-infektiøs organiserende pneumoni under anvendelse af ustekinumab efter godkendelsen.
English: Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.
Danish: Det bør overvejes at seponere behandlingen hos patienter, som ikke har udvist respons efter 28 ugers behandling.
English: • It is preferable to avoid the use of Stelara in pregnancy.
Danish: • Det er bedst at lade være med at bruge Stelara under graviditet.
English: In Psoriasis Study 1 maintenance of PASI 75 was significantly superior with continuous treatment compared with treatment withdrawal (p < 0.001).
Danish: I psoriasisstudie 1 var opretholdelsen af PASI 75 signifikant bedre ved fortsat behandling sammenlignet med behandlingsophør (p < 0,001).
English: STELARA must not be given to patients with active tuberculosis (see section 4.3).
Danish: STELARA må ikke gives til patienter med aktiv tuberkulose (se pkt.
English: Stelara is used to treat the following inflammatory diseases:
Danish: Stelara bruges til at behandle følgende betændelseslignende (inflammatoriske) sygdomme:
English: These improvements were maintained in ustekinumab-treated patients in UNIFI-M through week 44.
Danish: Disse forbedringer blev opretholdt hos de patienter, der blev behandlet med ustekinumab i UNIFI-M til uge 44.
English: Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.
Danish: Patienterne skal have besked om at søge læge, hvis der opstår tegn eller symptomer, der tyder på en infektion.
English: These medicines work by weakening part of the immune system.
Danish: Disse lægemidler virker ved at svække dele af immunsystemet.
English: Similar symptoms sometimes develop as a natural change in the type of psoriasis symptoms (erythrodermic psoriasis)
Danish: Somme tider udvikles der lignende symptomer som en naturlig ændring i symptomerne på psoriasis (erytroderm psoriasis).
English: The effects of Stelara in pregnant women are not known.
Danish: Stelaras virkning på gravide kendes ikke.
English: The primary endpoint for both induction studies was the proportion of subjects in clinical response (defined as a reduction in CDAI score of ≥ 100 points) at week 6.
Danish: Det primære endepunkt i begge induktionsstudier var andelen af forsøgspersoner med klinisk respons (defineret som en reduktion i CDAI-score på ≥ 100 point) i uge 6.
English: STELARA 130 mg is for intravenous use only.
Danish: STELARA 130 mg er kun til intravenøs anvendelse.
English: Patients in UNITI-1 had failed or were intolerant to prior anti-TNFα therapy.
Danish: Patienterne i UNITI-1 havde ikke responderet på eller var intolerante over for tidligere anti-TNF-alfaterapi.
English: The pharmacokinetics of ustekinumab were generally comparable between Asian and non-Asian patients with psoriasis and ulcerative colitis.
Danish: Ustekinumabs farmakokinetik var generelt sammenlignelig hos asiatiske og ikke-asiatiske patienter med psoriasis og colitis ulcerosa.
English: In the population pharmacokinetic analysis, there were no indications of an effect of tobacco or alcohol on the pharmacokinetics of ustekinumab.
Danish: I den farmakokinetiske populationsanalyse var der ingen indikationer på, at tobak eller alkohol har effekt på farmakokinetikken af ustekinumab.
English: Clinical presentations included cough, dyspnoea, and interstitial infiltrates following one to three doses.
Danish: Kliniske billeder omfattede hoste, dyspnø og interstitielle infiltrater efter en til tre doser.
English: It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin (BCG)) should not be given concurrently with STELARA.
Danish: Det anbefales, at vacciner med levende vira eller levende bakterier (f.eks. Bacillus Calmette-Guérin (BCG)) ikke gives samtidig med STELARA.
English: ACR 20, 50 and 70 responses continued to improve or were maintained through week 52 (PsA Study 1 and 2) and week 100 (PsA Study 1).
Danish: Bedringen af ACR 20, 50 og 70 respons fortsatte eller blev opretholdt til og med uge 52 (PsA-studie 1 og 2) og uge 100 (PsA-studie 1).
English: • If you have or have had a recent infection or if you have any abnormal skin openings (fistulae).
Danish: • Hvis du har eller for nylig har haft en infektion, eller hvis du har unormale åbninger i huden (fistler).
English: This stops air bubbles forming in the syringe (see Figure 4)
Danish: Det forhindrer dannelsen af luftbobler i sprøjten (se figur 4).
English: • Moderate to severe Crohn's disease - in adults
Danish: • Moderat til svær Crohns sygdom hos voksne
English: Stelara may make you less able to fight infections, and some infections could become serious.
Danish: Stelara kan nedsætte din evne til at bekæmpe infektioner, og nogle infektioner kan blive alvorlige.
English: The impact of these covariates was within ±20% of the typical or reference value of the respective PK parameter, thus dose adjustment is not warranted for these covariates.
Danish: Indvirkningen af disse kovarianter lå inden for ± 20% af den typiske værdi eller referenceværdi for de respektive farmakokinetiske parametre, hvorfor dosisjustering ikke er påkrævet for disse kovarianter.
English: CDLQI of 0 or 1
Danish: CDLQI på 0 eller 1
English: Similar disease severity was also seen in Psoriasis Study 3.
Danish: Lignende sygdomsalvorlighed blev set i psoriasisstudie 3.
English: Maintenance of Clinical Remission through week 44
Danish: Opretholdelse af klinisk remission til uge 44
English: The effect is considered demonstrated irrespective of concomitant MTX use, and was maintained through Weeks 52 (integrated analysis) and 100 (PsA Study 1).
Danish: Virkningen anses for dokumenteret uafhængigt af samtidig anvendelse af MTX, og den blev opretholdt til og med uge 52 (integreret analyse) og uge 100 (PsA-studie 1).
English: * See section 4.4, Systemic and respiratory hypersensitivity reactions.
Danish: 4.4, Systemiske og respiratoriske overfølsomhedsreaktioner.
English: • If you have ever had an allergic reaction to latex or Stelara injection - the container of this medicinal product contains latex rubber, which may cause severe allergic reactions in people who are sensitive to latex.
Danish: • Hvis du nogensinde har haft en allergisk reaktion over for latex eller Stelara injektionlægemidlets beholder indeholder latex, som kan give alvorlige allergiske reaktioner hos personer, der er overfølsomme over for denne gummi.
English: At week 12, placebo treated patients crossed over to receive ustekinumab.
Danish: I uge 12 krydsede placebobehandlede patienter over til at få ustekinumab.
English: • The doctor will work out the right dose for you, including the amount (volume) of Stelara to be injected to give the right dose.
Danish: • Lægen vil fastlægge den rigtige dosis til dig, herunder den mængde (det volumen) af Stelara,
English: Endoscopic appearance of the mucosa was evaluated in 252 patients with eligible baseline endoscopic disease activity in a substudy.
Danish: Mucosas udseende ved endoskopi blev evalueret hos 252 patienter, som havde kvalificerende endoskopisk sygdomsaktivitet ved baseline i delstudiet.
English: Choose and prepare the injection site:
Danish: Vælg og forbered injektionsstedet:
English: • Reduce the signs and symptoms of your disease.
Danish: • for at reduceret symptomerne på sygdommen
English: Recommended dose of Ustekinumab
Danish: Anbefalet dosis af ustekinumab
English: From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately.
Danish: Ud fra en mikrobiologisk synsvinkel skal lægemidlet anvendes straks, medmindre proceduren ved fortynding udelukker risiko for mikrobiel forurening.
English: Comprehensive instructions for administration are given in the package leaflet.
Danish: I indlægssedlen gives der grundige anvisninger i administration.
English: Structural damage in both hands and feet was expressed as change in total van der Heijde-Sharp score (vdH-S score), modified for PsA by addition of hand distal interphalangeal joints, compared to baseline.
Danish: Strukturelle skader i både hænder og fødder blev udtrykt som ændring i forhold til baseline i den samlede van der Heijde-Sharp-score (vdH-S-score) modificeret til PsA ved tilføjelse af hændernes distale interfalangeale led.
English: Beyond week 12, efficacy was generally higher and better sustained in the recommended dose group compared with half of the recommended dosage group in which a modest loss of efficacy was more frequently observed toward the end of each 12 week dosing interval.
Danish: Efter uge 12 var virkningen generelt større og bedre bibeholdt hos den gruppe, der fik den anbefalede dosis, sammenlignet med den gruppe, der fik halvdelen af den anbefalede dosis, hos hvem et moderat tab af virkning sås hyppigere henimod slutningen af hvert 12-ugers doseringsinterval.
English: The maintenance study (IM-UNITI), evaluated 388 patients who achieved 100 point clinical response at week 8 of induction with ustekinumab in studies UNITI-1 and UNITI-2.
Danish: Vedligeholdelsesstudiet (IM-UNITI) evaluerede 388 patienter, der havde opnået et klinisk respons på 100 point i uge 8 efter induktion med ustekinumab i studie UNITI-1 og UNITI-2.
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC05.
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, interleukinhæmmere, ATC-kode: L04AC05
English: Number of patients with ≥ 3% BSA psoriasis skin involvement at baseline
Danish: Antal patienter med hud påvirket af psoriasis på ≥ 3% BSA ved baseline
English: As a precautionary measure, it is preferable to avoid the use of STELARA in pregnancy.
Danish: Som en sikkerhedsforanstaltning anbefales det at undgå brugen af STELARA i forbindelse med graviditet.
English: Similar results were obtained from a confirmatory population pharmacokinetic analysis using data from patients with psoriatic arthritis.
Danish: Tilsvarende resultater blev opnået i en konfirmatorisk populationsfarmakokinetiske analyse, hvor der anvendtes data fra patienter med psoriasisartrit.
English: If you forget to use Stelara
Danish: Hvis du har glemt at bruge Stelara
English: It is not known whether STELARA may affect allergy immunotherapy.
Danish: Det vides ikke, om STELARA påvirker allergenspecifik immunterapi.
English: • Do not touch the needle or allow it to touch any surface
Danish: • Rør ikke nålen, og lad den ikke berøre nogen overflade.
English: Push it slowly and evenly, keeping the skin gently pinched
Danish: Tryk det ind med en langsom og jævn bevægelse, og sørg for at holde hudfolden let klemt sammen.
English: Clinical Response (100 point), week 6 53 (21.5%) 84 (33.7%)
Danish: Klinisk respons (100 point), uge 6 53 (21,5%) 84 (33,7%)
English: Approximately 6 mg/kg
Danish: Cirka 6 mg/kg
English: Talk to your doctor about when you will have your injections and follow-up appointments.
Danish: Tal med lægen om, hvornår du skal have dine injektioner og opfølgende kontrol.
English: • Do not pull back on the plunger at any time
Danish: • Træk ikke tilbage i stemplet på noget tidspunkt.
English: Psoriasis Study 1 (PHOENIX 1) evaluated 766 patients.
Danish: I psoriasisstudie 1 (PHOENIX 1) blev 766 patienter vurderet.
English: All patients, in particular those greater than 60 years of age, patients with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be monitored for the appearance of non-melanoma skin cancer (see section 4.8).
Danish: Alle patienter, og især patienter over 60 år, patienter med langvarig immunsuppression i anamnesen og patienter, der tidligere har fået PUVA-behandling, skal monitoreres for forekomst af ikke-melanom hudkræft (se pkt.
English: • Do not touch the needle guard activation clips (as indicated by asterisks * in Figure 1) to prevent prematurely covering the needle with the needle guard.
Danish: • Rør ikke nålebeskyttelsesaktiveringstappene (som er markeret med * på figur 1) for at undgå for tidlig tildækning af nålen med nålebeskyttelsesafskærmningen.
English: Patients receiving STELARA may receive concurrent inactivated or non-live vaccinations.
Danish: Patienter i behandling med STELARA kan vaccineres med inaktiverede eller ikke-levende vacciner.
English: If you are the parent or caregiver who will give Stelara to a child, please read this information carefully.
Danish: Forældre eller omsorgspersoner, som skal give Stelara til et barn, skal læse indlægssedlen grundigt.
English: The CL/F of ustekinumab was not impacted by gender.
Danish: CL/F af ustekinumab blev ikke påvirket af køn.