FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the 1384 plaque psoriasis patients exposed to guselkumab and included in the population pharmacokinetic analysis, 70 patients were 65 years of age or older, including 4 patients who were 75 years of age or older.
Danish: Af de 1384 patienter med plaque-psoriasis, som blev eksponeret for guselkumab og medtaget i den farmakokinetiske populationsanalyse, var 70 patienter 65 år eller ældre, herunder 4 patienter, der var 75 år eller ældre.
English: Of all patients included in VOYAGE 1 and 2, 32% and 29% were naïve to both conventional systemic and biologic therapy, 54% and 57% had received prior phototherapy, and 62% and 64% had received prior conventional systemic therapy, respectively.
Danish: Af alle de patienter, der deltog i VOYAGE 1 og 2, var henholdsvis 32 % og 29 % behandlingsnaive for både konventionel systemisk og biologisk behandling, henholdsvis 54 % og 57 % havde tidligere fået lysbehandling og henholdsvis 62 % og 64 % havde tidligere fået konventionel systemisk behandling.
English: Comparative PASI response rates are presented in Table 6.
Danish: En sammenligning af PASI-responsrater er vist i tabel 6.
English: The efficacy of guselkumab was evaluated with respect to overall skin disease, regional disease (scalp, hand and foot and nails) and quality of life and patient reported outcomes.
Danish: Virkningen af guselkumab blev vurderet i forhold til overordnet hudsygdom, regional sygdom (hovedbund, hænder og fødder og negle) samt livskvalitet og patientrapporterede resultater.
English: After injection, the needle will retract into the body of the device and lock into place.
Danish: Efter injektionen trækkes kanylen tilbage ind i anordningen og låses på plads.
English: The NAVIGATE study examined the efficacy of guselkumab in patients who had an inadequate response (ie, who had not achieved a ‘cleared' or ‘minimal' response defined as IGA ≥ 2) to ustekinumab at Week 16.
Danish: NAVIGATE-studiet undersøgte virkningen af guselkumab hos patienter, som havde et utilstrækkeligt respons (dvs. som ikke opnåede responset „clear“ eller „minimal“ defineret som IGA ≥ 2) på ustekinumab i uge 16.
English: Two studies (VOYAGE 1 and VOYAGE 2) evaluated the efficacy and safety of guselkumab versus placebo and adalimumab in 1829 adult patients.
Danish: To studier (VOYAGE 1 og VOYAGE 2) vurderede guselkumabs virkning og sikkerhed versus placebo og adalimumab hos 1829 voksne patienter.
English: In both studies, 21% had received prior biologic therapy, including 11% who had received at least one anti-tumour necrosis factor alpha (TNFα) agent, and approximately 10% who had received an anti-IL-12/IL-23 agent.
Danish: I begge studier havde 21 % tidligere fået biologisk behandling; 11 % havde fået mindst en TNFα-hæmmer (tumornekrosefaktor alfa) og ca. 10 % havde fået en IL-12/IL-23-hæmmer.
English: It is unknown whether guselkumab is excreted in human milk.
Danish: Det er ukendt, om guselkumab udskilles i human mælk.
English: Do not hold or pull plunger at any time.
Danish: Undlad at holde eller trække i stemplet på noget tidspunkt.
English: Clinically important active infections (e.g., active tuberculosis, see section 4.4).
Danish: Klinisk betydningsfulde aktive infektioner (f.eks. aktiv tuberkulose; se pkt.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, toxicity to reproduction and pre- and post-natal development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, reproduktionstoksicitet samt præ- og postnatal udviklingstoksicitet.
English: In the event of overdosage, monitor the patient for any signs or symptoms of adverse reactions and administer appropriate symptomatic treatment immediately.
Danish: I tilfælde af overdosering anbefales det at overvåge patienten for tegn eller symptomer på bivirkninger samt at iværksætte passende symptomatisk behandling øjeblikkeligt.
English: Among patients who inadequately responded to ustekinumab at the time of randomisation, significantly greater improvement of efficacy was observed in patients who switched to guselkumab treatment compared to patients who continued ustekinumab treatment.
Danish: Blandt de patienter, der havde utilstrækkeligt respons på ustekinumab på tidspunktet for randomisering, blev der observeret signifikant større forbedring i virkningen hos patienter, som skiftede til guselkumab-behandling, sammenlignet med patienter, som fortsatte med ustekinumab-behandling.
English: Some side effects are very common (may affect more than 1 in 10 people): - upper respiratory infections
Danish: Nogle bivirkninger er meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter): - infektioner i de øvre luftveje
English: Adverse reactions of gastroenteritis were non-serious and did not lead to discontinuation of Tremfya through Week 156.
Danish: Gastroenteritis som bivirkning var ikke af svær grad og medførte ikke seponering af Tremfya til og med uge 156.
English: Treatment with guselkumab resulted in significant improvements in the measures of disease activity compared to placebo and adalimumab at Week 16 and compared to adalimumab at Weeks 24 and 48.
Danish: Behandling med guselkumab resulterede i signifikante forbedringer i målinger af sygdomsaktivitet sammenlignet med placebo og adalimumab i uge 16 og sammenlignet med adalimumab i uge 24 og 48.
English: See section 5.3 for information on the excretion of guselkumab in animal (cynomolgus monkey) milk.
Danish: 5.3 for oplysninger om udskillelse af guselkumab i mælk hos dyr (cynomolgusaber).
English: Store in refrigerator at 2° to 8°C.
Danish: Opbevares i køleskab ved 2 °C til 8 °C.
English: Tremfya is a clear, colourless to light yellow solution.
Danish: Tremfya er en klar, farveløs til lys gul opløsning.
English: Additionally, there were no adverse immunotoxicity or cardiovascular safety pharmacology effects noted during the conduct of the repeat-dose toxicity studies or in a targeted cardiovascular safety pharmacology study in cynomolgus monkeys.
Danish: Endvidere var der ingen farmakologiske bivirkninger relateret til immuntoksicitet eller kardiovaskulær sikkerhed under udførelsen af toksicitetsstudiet med gentagne doser eller i et målrettet farmakologisk studie af kardiovaskulær sikkerhed hos cynomolgusaber.
English: Prior to use, a visual inspection of the pre-filled syringe or pre-filled pen is recommended.
Danish: Før brug anbefales en visuel inspektion af den fyldte injektionssprøjte eller den fyldte pen.
English: Name and address of the manufacturer responsible for batch release Janssen Biologics B.V.
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Janssen Biologics B.V.
English: The improvements in SF-36, HADS and WLQ were all maintained through Week 48 and in the open-label phase through Week 156 among patients randomised to maintenance therapy at Week 28.
Danish: Forbedringerne i SF-36, HADS og WLQ blev alle opretholdt til og med uge 48 og i den ikke-blindede fase til og med uge 156 blandt de patienter, der blev randomiseret til vedligeholdelsesbehandling i uge 28.
English: Place your thumb, index and middle fingers directly under the finger flange, as shown.
Danish: Placer din tommel- pege- og langfinger direkte under fingerkraven som vist.
English: The recommended dose of Tremfya is 100 mg by subcutaneous injection at weeks 0 and 4, followed by a maintenance dose every 8 weeks.
Danish: Den anbefalede dosis af Tremfya er 100 mg som subkutan injektion ved uge 0 og 4 efterfulgt af en vedligeholdelsesdosis hver 8. uge.
English: Stop using Tremfya and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious allergic reaction or an infection.
Danish: Stop med at bruge Tremfya og fortæl det straks til din læge eller søg akut lægehjælp, hvis du bemærker tegn på en alvorlig allergisk reaktion eller en infektion.
English: EU/1/17/1234/001 1 pre-filled syringe EU/1/17/1234/002 1 pre-filled pen EU/1/17/1234/003 2 pre-filled pens EU/1/17/1234/004 2 pre-filled syringes
Danish: EU/1/17/1234/001 1 fyldt injektionssprøjte EU/1/17/1234/002 1 fyldt pen EU/1/17/1234/003 2 fyldte penne EU/1/17/1234/004 2 fyldte injektionssprøjter
English: After randomisation, the primary endpoint was the number of post-randomisation visits between Weeks 12 and 24 at which patients achieved an IGA score 0/1 and had ≥ 2 grade improvement.
Danish: Efter randomisering var det primære endpoint antallet af besøg efter randomisering mellem uge 12 og 24, hvor patienterne opnåede en IGA-score 0/1 samt havde ≥ 2 graders forbedring.
English: Tremfya has no or negligible influence on the ability to drive and use machines.
Danish: Tremfya påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Women of childbearing potential should use effective methods of contraception during treatment and for at least 12 weeks after treatment.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i mindst 12 uger efter behandlingen.
English: If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Tremfya and for at least 12 weeks after the last Tremfya dose.
Danish: Hvis du er en kvinde i den fødedygtige alder, rådes du til at undgå at blive gravid, og du skal bruge sikker prævention, mens du bruger Tremfya og i mindst 12 uger efter den sidste dosis af Tremfya.
English: Concomitant immunosuppressive therapy or phototherapy The safety and efficacy of Tremfya in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Danish: Samtidig immunsupprimerende behandling eller lysbehandling Sikkerheden og virkningen af Tremfya i kombination med immunsuppressiva, herunder biologiske lægemidler, eller lysbehandling er ikke blevet vurderet.
English: As a human IgG mAb, guselkumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Danish: Som et humant IgG-mAb forventes guselkumab at blive nedbrudt til små peptider og aminosyrer via kataboliske veje på samme måde som endogent IgG.
English: There is no need for dose adjustment when co-administering guselkumab and CYP450 substrates.
Danish: Dosisjustering er ikke nødvendig ved samtidig administration af guselkumab og CYP450-substrater.
English: Adverse reactions of injection site erythema and injection site pain were generally mild to moderate in severity; none were serious, and none led to discontinuation of Tremfya.
Danish: Reaktioner på injektionsstedet som bivirkning var erytem og smerter på injektionsstedet, generelt var tilfældene af let til moderat sværhedsgrad, ingen var alvorlige og ingen førte til seponering af Tremfya.
English: Summary of the safety profile The most common adverse drug reaction (ADR) was upper respiratory infection.
Danish: Resumé af sikkerhedsprofilen De mest almindelige bivirkninger var infektion i de øvre luftveje.
English: Guselkumab demonstrated rapid onset of efficacy, with a significantly higher percent improvement in PASI as compared with placebo as early as Week 2 (p < 0.001).
Danish: Guselkumab viste hurtig indledende virkning med en signifikant højere procentvis forbedring i PASI sammenlignet med placebo allerede i uge 2 (p < 0,001).
English: Place thumb from the opposite hand on the plunger and press the plunger all the way down until it stops.
Danish: Placer den modsatte hånds tommelfinger på stemplet, og tryk stemplet hele vejen ned, indtil det stopper.
English: A weekly subcutaneous dose of 50 mg/kg to monkeys resulted in exposure (AUC) and Cmax values that were at least 49-fold and >200-fold higher, respectively, than those measured in the human clinical PK study.
Danish: En ugentlig subkutan dosis på 50 mg/kg til aber medførte eksponerings- (AUC) og Cmax-værdier, som var henholdsvis mindst 49 og >200 gange højere end dem, der blev målt i det farmakokinetiske populationsstudie med mennesker.
English: In two phase III clinical studies through the placebo-controlled period, gastroenteritis occurred more frequently in the Tremfya-treated group (1.1%) than in the placebo group (0.7%).
Danish: I den placebokontrollerede periode i to kliniske fase III-studier forekom gastroenteritis hyppigere i den gruppe, der blev behandlet med Tremfya (1,1 %), end i placebogruppen (0,7 %).
English: Push handle straight down
Danish: Tryk håndtaget lige ned
English: Keep hands away from the needle guard after the cap is removed.
Danish: Hold hænderne væk fra kanylebeskyttelsen, når du har fjernet hætten.
English: Inspect carton
Danish: Kontrollér kartonen
English: Mean volume of distribution during the terminal phase (Vz) following a single intravenous administration to healthy subjects ranged from approximately 7 to 10 L across studies.
Danish: Det gennemsnitlige fordelingsvolumen i løbet af den terminale fase (Vz) efter en enkelt intravenøs administration til raske forsøgspersoner lå i intervallet ca. 7 til 10 l på tværs af studierne.
English: In addition, reduced serum IL-17A, IL-17F and IL-22 levels compared to placebo were observed in guselkumab treated patients in phase II and phase III studies.
Danish: Desuden blev der observeret reducerede serumkoncentrationer af IL-17A, IL-17F og IL-22 sammenlignet med placebo hos patienter behandlet med guselkumab i fase II- og fase III-studier.
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: Dyreforsøg indikerer hverken direkte eller indirekte skadelige virkninger hvad angår graviditeten, den embryonale/føtale udvikling, fødslen eller den postnatale udvikling (se pkt.
English: Live vaccines should not be used concurrently in patients treated with Tremfya.
Danish: Levende vacciner bør ikke anvendes til patienter, som samtidigt behandles med Tremfya.
English: Tremfya contains the active substance guselkumab which is a type of protein called a monoclonal antibody.
Danish: Tremfya indeholder det aktive stof guselkumab, som er en type protein, der kaldes et monoklonalt antistof.
English: A decision should be made whether to discontinue, or abstain from initiating treatment with Tremfya, taking into account the benefit of breast-feeding to the child and the benefit of Tremfya therapy to the woman.
Danish: Det skal besluttes, om behandlingen med Tremfya skal seponeres eller slet ikke igangsættes, idet der tages højde for fordelene ved amning for barnet i forhold til fordelene ved behandling med Tremfya for kvinden.
English: It is important not to try to inject yourself until you have been trained by your doctor or nurse.
Danish: Det er vigtigt, at du ikke prøver at injicere selv, før lægen eller sundhedspersonalet har vist dig, hvordan du skal gøre.
English: 2333CB Leiden The Netherlands
Danish: NL-2333 CB Leiden Holland
English: Mean systemic clearance (CL) following a single intravenous administration to healthy subjects ranged from 0.288 to 0.479 L/day across studies.
Danish: Gennemsnittet for systemisk clearance (Cl) efter en enkelt intravenøs administration til raske forsøgspersoner lå i intervallet 0,288 til 0,479 l/dag på tværs af studierne.
English: 2333CB Leiden
Danish: NL-2333 CB Leiden
English: In repeat-dose toxicity studies in cynomolgus monkeys, guselkumab was well tolerated via intravenous and subcutaneous routes of administration.
Danish: I studier med gentagne doser givet til cynomolgusaber var guselkumab veltolereret via intravenøse og subkutane administrationsveje.
English: VOYAGE 1 and VOYAGE 2
Danish: VOYAGE 1 og VOYAGE 2
English: Keep Tremfya and all medicines out of reach of children.
Danish: Tremfya og alle andre lægemidler skal opbevares utilgængeligt for børn.
English: The solution is clear and colourless to light yellow.
Danish: Opløsningen er klar og farveløs til lys gul.
English: Signs of improvement on patient-reported outcomes were maintained through Week 24 (VOYAGE 1 and 2) and Week 48 (VOYAGE 1).
Danish: Tegn på forbedring i patientrapporterede resultater blev opretholdt til og med uge 24 (VOYAGE 1 og 2) og uge 48 (VOYAGE 1).
English: Do not use Tremfya
Danish: Brug ikke Tremfya
English: In the same phase I study, treatment with guselkumab resulted in improvement of histological measures of psoriasis at Week 12, including reductions in epidermal thickness and T-cell density.
Danish: I det samme fase I studie resulterede behandling med guselkumab i forbedring af histologiske målinger af psoriasis i uge 12, inklusive reduktioner i epidermal tykkelse og T-celledensitet.
English: Summary of Patient Reported Outcomes in the Open-Label Phase in VOYAGE 1 Guselkumab
Danish: Oversigt over patientrapporterede resultater i den ikke-blindede fase i VOYAGE 1 Guselkumab
English: Percent of Subjects (%)
Danish: Procentdel af forsøgspersoner (%)
English: Tremfya is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis.
Danish: Tremfya er beregnet til brug under vejledning og tilsyn af en læge, der har erfaring med diagnosticering og behandling af plaque-psoriasis.
English: Possible serious allergic reaction - the signs may include: - difficulty breathing or swallowing - swelling of the face, lips, tongue or throat - severe itching of the skin, with a red rash or raised bumps
Danish: Mulige alvorlige allergiske reaktioner - tegnene kan inkludere: - besvær med at trække vejret eller synke - hævelser i ansigt, læber, tunge eller svælg - kraftigt kløende hud med et rødt udslæt eller hævede buler
English: It should be clear to slightly yellow and may contain tiny white or clear particles.
Danish: Den skal være klar til let gul og kan indeholde små hvide eller gennemsigtige partikler.
English: IL-23, a regulatory cytokine, affects the differentiation, expansion, and survival of T cell subsets, (e.g., Th17 cells and Tc17 cells) and innate immune cell subsets, which represent sources of effector cytokines, including IL-17A, IL-17F and IL-22 that drive inflammatory disease.
Danish: IL-23 et er regulatorisk cytokin, som påvirker differentiering, ekspansion og overlevelse af en subgruppe af T-celler (f.eks. Th17-celler og Tc17-celler) og medfødte subgrupper af immunceller, som producerer effektor-cytokiner, herunder IL-17A, IL-17F og IL-22, som driver inflammatorisk sygdom.
English: Efficacy and safety of guselkumab were also investigated in a double-blind study compared to secukinumab.
Danish: Guselkumabs virkning og sikkerhed sammenlignet med secukinumab blev ligeledes undersøgt i et dobbeltblindt studie.
English: Prior to initiating treatment with Tremfya, patients should be evaluated for tuberculosis (TB) infection.
Danish: Inden behandling med Tremfya påbegyndes, skal patienten undersøges for tuberkuloseinfektion.
English: The co-primary endpoints in VOYAGE 1 and 2 were the proportion of patients who achieved an IGA score of cleared or minimal (IGA 0/1) and a PASI 90 response at Week 16 versus placebo (see Table 2).
Danish: Der var to primære endepunkter i VOYAGE 1 og 2: andelen af patienter, som opnåede en IGA-score på clear eller minimal (IGA 0/1), og et PASI 90-respons i uge 16 versus placebo (se tabel 2).
English: In pooled phase II and phase III analyses, fewer than 6% of patients treated with Tremfya developed antidrug antibodies in up to 52 weeks of treatment.
Danish: I puljede fase II- og fase III-analyser udviklede færre end 6 % af de patienter, der blev behandlet med Tremfya, antistoffer mod lægemidlet i løbet af op til 52 ugers behandling.
English: The efficacy and safety of guselkumab was assessed in three randomised, double-blind, active controlled phase III studies in adult patients with moderate to severe plaque psoriasis, who were candidates for phototherapy or systemic therapy.
Danish: Guselkumabs sikkerhed og virkning blev vurderet i tre randomiserede, dobbeltblinde, aktivt kontrollerede fase III-studier hos voksne patienter med moderat til svær plaque-psoriasis, som var kandidater til lysbehandling eller systemisk behandling.
English: Anti-TB therapy should be considered prior to initiating Tremfya in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Danish: Antituberkuløs behandling skal overvejes, inden behandling med Tremfya påbegyndes hos patienter med latent eller aktiv tuberkulose i anamnesen, hvor et tidligere adækvat behandlingsforløb ikke kan bekræftes.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Tremfya in plaque psoriasis in one or more subsets of the paediatric population (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat kravet om at fremlægge resultaterne af studier med Tremfya i en eller flere undergrupper af den pædiatriske population med plaque-psoriasis (se pkt.
English: Figure 3: Percent of Subjects Who Achieved an IGA Score of Cleared (0) or Minimal (1) and at least a 2-grade improvement in IGA from Week 0 Through Week 24 by Visit After Randomisation in NAVIGATE
Danish: Figur 3: Procentdel af forsøgspersoner, som opnåede IGA-scoren Clear (0) eller Minimal (1) og mindst en 2-graders forbedring i IGA fra uge 0 til og med uge 24 per besøg efter randomisering i NAVIGATE
English: Steady-state serum guselkumab concentrations were achieved by Week 20 following subcutaneous administrations of 100 mg guselkumab at Weeks 0 and 4, and every 8 weeks thereafter.
Danish: Steady-state serumkoncentration af guselkumab blev opnået i uge 20 efter subkutan administration af 100 mg guselkumab i uge 0 og 4 og hver 8. uge herefter.
English: Position the pre-filled pen straight onto the skin (about 90 degrees relative to injection site).
Danish: Placer den fyldte pen vinkelret på huden (med en vinkel på 90 grader i forhold til injektionsstedet).
English: The absolute bioavailability of guselkumab following a single 100 mg subcutaneous injection was estimated to be approximately 49% in healthy subjects.
Danish: Den absolutte biotilgængelighed af guselkumab efter en enkelt subkutan injektion af 100 mg blev estimeret til 49 % hos raske forsøgspersoner.
English: Do not inject if perforations on the carton are broken.
Danish: Undlad at injicere, hvis perforeringen på kartonen er brudt.
English: Through Week 156, 4.9% of all Tremfya-treated patients reported gastroenteritis.
Danish: Til og med uge 156 rapporterede 4,9 % af alle de patienter, der blev behandlet med Tremfya, gastroenteritis.
English: Following a single 100 mg subcutaneous injection in healthy subjects, guselkumab reached a mean (± SD) maximum serum concentration (Cmax) of 8.09 ± 3.68 mcg/mL by approximately 5.5 days post dose.
Danish: Efter en enkelt 100 mg subkutan injektion hos raske forsøgspersoner nåede guselkumab en gennemsnitlig (± SD) maksimal serumkoncentration (Cmax) på 8,09 ± 3,68 μg/ml med ca. 5,5 dage efter dosering.
English: Through Week 156, 0.5% of Tremfya injections were associated with injection site reactions.
Danish: Til og med uge 156 var 0,5 % af injektionerne med Tremfya forbundet med reaktioner på injektionsstedet.
English: Histidine monohydrochloride monohydrate Polysorbate 80
Danish: Histidin-monohydrochlorid-monohydrat Polysorbat 80
English: The mean (± SD) steady-state trough serum guselkumab concentrations in two phase III studies were 1.15 ± 0.73 mcg/mL and 1.23 ± 0.84 mcg/mL.
Danish: Den gennemsnitlige (± SD) serumkoncentration af guselkumab for steady-state, var i to fase III-studier 1,15 ± 0,73 μg/ml og 1,23 ± 0,84 μg/ml.
English: Do not touch plunger or area above finger flange as this may cause the needle safety device to activate.
Danish: Undlad at berøre stemplet eller området over fingerkraven, da det kan aktivere kanylesikkerhedsanordningen.
English: Use your free hand to grasp the body of the syringe.
Danish: Brug din frie hånd til at tage fat om sprøjtecylinderen.
English: Guselkumab could not be detected in breast milk from cynomolgus monkeys as measured at post-natal day 28.
Danish: Guselkumab kunne ikke påvises i modermælk fra cynomolgusaber målt på dag 28 efter fødslen.