FrancophonIA/ELRC3.0 huggingface dataset:
English: Over the entire psoriasis programme including long-term exposure to risankizumab, the rate of infections was 75.5 events per 100 subject-years.
Danish: I hele psoriasisprogrammet, inklusive langvarig eksponering for risankizumab, var infektionshyppigheden 75,5 hændelser pr. 100 patientår.
English: Table 4: Efficacy and quality of life results at week 16 in adults with plaque psoriasis in IMMVENT
Danish: Tabel 4: Effekt- og livskvalitetsresultater i uge 16 hos voksne med plaque-psoriasis i IMMVENT
English: • Speak to your doctor, pharmacist or nurse if you think you have not given a full dose
Danish: • Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis du mener, at du ikke har indgivet en fuld dosis.
English: Across all studies, 30.9% of subjects were naïve to any systemic therapy (including non-biologic and biologic), 38.1% had received prior phototherapy or photochemotherapy, 48.3% had received prior non-biologic systemic therapy, 42.1% had received prior biologic therapy, and 23.7% had received at least one anti-TNF alpha agent for the treatment of psoriasis.
Danish: På tværs af alle studierne var 30,9 % af patienterne naive over for enhver systemisk behandling (herunder ikke-biologiske og biologiske), 38,1 % havde tidligere fået lysbehandling eller fotokemoterapi, 48,3 % havde tidligere fået ikke-biologisk systemisk behandling, 42,1 % havde tidligere fået biologisk behandling, og 23,7 % havde fået mindst ét anti-TNF-alfa-lægemiddel til behandling af psoriasis.
English: • if the syringe has been dropped or damaged
Danish: • hvis sprøjten har været tabt eller er blevet beskadiget
English: Of the 31 subjects from the IMMHANCE study with latent tuberculosis (TB) who did not receive prophylaxis during the study, none developed active TB during the mean follow-up of 55 weeks on risankizumab.
Danish: Ud af de 31 patienter fra IMMHANCE med latent tuberkulose (TB), der ikke fik profylakse under forsøget, udviklede ingen aktiv TB i løbet af den gennemsnitlige risankizumab-opfølgning på 55 uger.
English: Talk to your doctor, pharmacist or nurse before and during the use of Skyrizi:
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken før og under anvendelse af Skyrizi hvis:
English: Among the few subjects (approximately 1%; 7/1,000 at week 16 and 6/598 at week 52) with high antibody titers (>128), clinical response appeared to be reduced.
Danish: Blandt de få patienter (ca. 1 %; 7/1.000 i uge 16 og 6/598 i uge 52) med høje antistof-titre (> 128) syntes det kliniske respons at være nedsat.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility.
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår fertilitet.
English: The incidence of injection site reactions is numerically higher in the anti-drug antibodypositive compared with anti-drug antibody-negative groups over short-term (16 weeks: 2.7% vs 1.3%) and longer term treatment (>52 weeks: 5.0% vs 3.3%).
Danish: Forekomsten af reaktioner på injektionsstedet er numerisk højere i de anti-risankizumab antistofpositive sammenlignet med anti-risankizumab antistof-negative grupper ved kort tid (16 uger: 2,7% mod 1,3%) og ved langtidsbehandling (> 52 uger: 5,0 % mod 3,3%).
English: In the event 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 overvåge patienten for tegn og symptomer på bivirkninger og straks iværksætte behandling af eventuelle symptomer.
English: The safety and efficacy of risankizumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Danish: Sikkerheden og virkningen ved risankizumab i kombination med immunsupprimerende lægemidler, herunder biologiske lægemidler, eller lysbehandling er ikke undersøgt.
English: These conditions are generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies and no dose adjustments are considered necessary (see section 5.2).
Danish: Disse tilstande forventes generelt ikke at have væsentlig betydning for farmakokinetikken af monoklonale antistoffer, og dosisjustering vurderes ikke at være nødvendigt (se pkt.
English: If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored and risankizumab should not be administered until the infection resolves.
Danish: Hvis en patient udvikler en sådan infektion eller ikke respondere på gængs behandling af infektionen, bør patienten overvåges tæt, og risankizumab bør seponeres, indtil infektionen fortager sig.
English: Week 52 249 (81.9) PASI 100
Danish: Uge 52 249 (81,9) PASI 100
English: Mutagenicity and carcinogenicity studies have not been conducted with risankizumab.
Danish: Der er ikke udført mutagenicitets- og karcinogenicitetsstudier med risankizumab.
English: Following subcutaneous dosing of risankizumab, peak plasma concentrations were achieved between 3-14 days after dosing with an estimated absolute bioavailability of 89%.
Danish: Ved subkutan administration af risankizumab opnåedes maksimal plasmakoncentration efter 3-14 dage med en skønnet absolut biotilgængelighed på 89 %.
English: Of the 2,234 subjects with plaque psoriasis exposed to risankizumab, 243 were 65 years or older and 24 subjects were 75 years or older.
Danish: Ud af de 2.234 patienter med plaque-psoriasis, der blev eksponeret for risankizumab, var 243 patienter 65 år eller derover, og 24 patienter var 75 år eller derover.
English: • fungal skin infection
Danish: • Svampeinfektion i huden
English: If you have used more Skyrizi than you should or the dose has been given sooner than prescribed, talk to your doctor.
Danish: Hvis du har taget for meget Skyrizi, eller hvis dosen er indgivet tidligere end planlagt, skal du tale med lægen.
English: Therapeutic IgG monoclonal antibodies are typically degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgGs.
Danish: Terapeutiske monoklonale IgG-antistoffer nedbrydes typisk til små peptider og aminosyrer via kataboliske mekanismer på samme måde som endogene IgG'er.
English: The needle will then be covered by the needle guard.
Danish: Så vil kanylen blive dækket af kanylebeskyttelsen.
English: Nail Psoriasis Severity Index (NAPSI), Palmoplantar Psoriasis Severity Index (PPASI), Psoriasis Scalp Severity Index (PSSI), and Standard Error (SE) ** P < 0.01 comparing to risankizumab *** P < 0.001 comparing to risankizumab
Danish: Nail Psoriasis Severity Index (NAPSI), Palmoplantar Psoriasis Severity Index (PPASI), Psoriasis Scalp Severity Index (PSSI) og standardfejl (SE) ** P < 0,01 sammenlignet med risankizumab *** P < 0,001 sammenlignet med risankizumab
English: For a full dose, two injections are needed, one after the other.
Danish: For at opnå den fulde dosis skal der indgives 2 injektioner efter hinanden.
English: There is limited information in subjects aged ≥65 years.
Danish: Ældre Der er begrænset information for patienter i alderen ≥65 år.
English: No dose adjustment is required (see section 5.2).
Danish: Dosisjustering er ikke nødvendigt (se pkt.
English: In 270 patients who switched from adalimumab to risankizumab without a washout period, the safety profile of risankizumab was similar to that in patients who initiated risankizumab after wash out of any prior systemic therapies.
Danish: Hos 270 patienter, der skiftede fra adalimumab til risankizumab uden en udvaskningsperiode, var risankizumabs sikkerhedsprofil den samme som sikkerhedsprofilen hos patienter, der påbegyndte behandling med risankizumab efter udvask af eventuelle tidligere systemiske behandlinger.
English: Skyrizi contains sorbitol and sodium This medicine contains 68 mg sorbitol per 150 mg dose.
Danish: Skyrizi indeholder sorbitol og natrium Dette lægemiddel indeholder 68 mg sorbitol pr. dosis på 150 mg.
English: Includes: respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis Includes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, onychomycosis Includes: headache, tension headache, sinus headache Includes: fatigue, asthenia Includes: injection site bruising, erythema, haematoma, haemorrhage, irritation, pain, pruritus, reaction, swelling
Danish: Omfatter: viral, bakteriel eller uspecificeret luftvejsinfektion, bihulebetændelse (herunder akut), rhinitis, betændelse i næse og svælg, faryngitis (herunder viral), tonsillitis Omfatter: fodsvamp, lyskesvamp, ringorm, tinea versicolor, håndfladesvamp og neglesvamp Omfatter: almindelig hovedpine, spændingshovedpine, sinushovedpine Omfatter: udmattelse, asteni Omfatter: blå mærker, erytem, hæmatom, hæmoragi, irritation, ømhed, pruritus, reaktion, hævelse
English: 2 Injections Required
Danish: Der skal indgives 2 injektioner
English: A total of 9.8% of study subjects had a history of diagnosed psoriatic arthritis.
Danish: I alt 9,8 % af patienterne var tidligere blevet diagnosticeret med psoriasisgigt.
English: The efficacy and safety of risankizumab was assessed in 2,109 subjects with moderate to severe plaque psoriasis in four multicentre, randomised, double-blind studies (ULTIMMA-1, ULTIMMA-2, IMMHANCE, and IMMVENT).
Danish: Risankizumabs sikkerhed og virkning blev vurderet hos 2.109 patienter med moderat til svær plaquepsoriasis i fire randomiserede, dobbeltblindede studier på flere centre (ULTIMMA-1, ULTIMMA-2, IMMHANCE og IMMVENT).
English: It is unknown whether risankizumab is excreted in human milk.
Danish: Det er ukendt, om risankizumab udskilles i human mælk.
English: Uncommon: may affect up to 1 in 100 people • small raised red bumps on the skin
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter): • Små røde knopper på huden
English: Table 3: Mean changes from baseline in NAPSI, PPASI, and PSSI ULTIMMA-1
Danish: Tabel 3: Gennemsnitlige ændringer fra baseline i NAPSI, PPASI og PSSI ULTIMMA-1
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Spørg på apotekspersonalet, hvordan du skal bortskaffe medicinrester.
English: • if you have recently had or are going to have a vaccination.
Danish: • du for nylig er blevet vaccineret eller snart skal vaccineres.
English: • warm, red and painful skin, or a painful skin rash with blisters
Danish: • Varm, rød og øm hud eller smertefuldt hududslæt med blærer
English: Read section 7 ‘Instructions for use' at the end of this leaflet before injecting Skyrizi yourself.
Danish: Læs punkt 7 'Brugsvejledning' bagerst i indlægssedlen, før du injicerer Skyrizi selv.
English: If a dose is missed, the dose should be administered as soon as possible.
Danish: Hvis en dosis glemmes, bør dosen administreres så hurtigt som muligt, og de efterfølgende doser indgives efter den oprindeligt planlagte tid.
English: • Do not throw away used syringes in the household waste
Danish: • Du må ikke smide de brugte sprøjter i skraldespanden.
English: The exposure of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), metoprolol (CYP2D6 substrate) and midazolam (CYP3A substrate) following risankizumab treatment were comparable to their exposures prior to risankizumab treatment, indicating no clinically meaningful drug interactions through these enzymes.
Danish: Eksponeringen for koffein (CYP1A2-substrat), warfarin (CYP2C9-substrat), omeprazol (CYP2C19-substrat), metoprolol (CYP2D6-substrat) og midazolam (CYP3A-substrat) efter behandling med risankizumab var den samme som eksponeringen inden behandling med risankizumab, hvilket tyder på, at der ikke forekommer klinisk relevante lægemiddelinteraktioner via disse enzymer.
English: • Keep the syringes in the carton until ready to inject
Danish: • Lad sprøjterne blive i æsken, indtil du er klar til at injicere.
English: A drug interaction study was conducted in subjects with plaque psoriasis to assess the effect of repeated administration of risankizumab on the pharmacokinetics of cytochrome P450 (CYP) sensitive probe substrates.
Danish: Et lægemiddelinteraktionsstudie blev gennemført med patienter med plaque-psoriasis for at undersøge, hvilken indvirkning gentagen administration af risankizumab har på farmakokinetikken af cytokrom P450 (CYP)-følsomme probe-substrater.
English: Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Danish: Behandling med risankizumab bør ikke påbegyndes hos patienter med klinisk vigtig aktiv infektion, før infektionen er ophørt eller behandlet tilstrækkeligt.
English: With dosing of 150 mg at week 0, week 4 and every 12 weeks thereafter, estimated steady-state peak and trough plasma concentrations are 12 and 2 µg/mL, respectively.
Danish: Ved administration af 150 mg i uge 0, uge 4 og derefter hver 12. uge var de estimerede højeste og laveste steady state-plasmakoncentrationer hhv. 12 og 2 µg/ml.
English: If a serious hypersensivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en alvorlig overfølsomhedsreaktion, bør risankizumab seponeres omgående og relevant behandling iværksættes.
English: Patients receiving risankizumab should be monitored for signs and symptoms of active TB.
Danish: Patienter, der får risankizumab, bør overvåges for tegn og symptomer på aktiv TB.
English: It may contain a few translucent to white product-related particles.
Danish: Den må gerne indeholde enkelte gennemsigtige til hvide lægemiddelrelaterede partikler.
English: Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment (see section 5.2).
Danish: Patienter, der behandles med risankizumab, bør ikke få levende vacciner under behandlingen og i mindst 21 uger efter behandlingen (se pkt.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår reproduktionstoksicitet.
English: Concomitant immunosuppressive therapy or phototherapy
Danish: Samtidig immunsupprimerende behandling eller lysterapi
English: LABEL
Danish: ETIKET
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel, da man ikke ved, hvilken indvirkning dette lægemiddel vil have på barnet.
English: Nonclinical data revealed no special hazard for humans based on repeat-dose toxicity studies including safety pharmacology evaluations, and a reproductive and developmental toxicity study in cynomolgus monkeys at doses of up to 50 mg/kg/week (producing exposures of about 70 times the clinical exposure at maximum recommended human dose [MRHD]).
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra studier af toksicitet efter gentagne doser, herunder undersøgelse af sikkerhedsfarmakologi, samt et studie af reproduktions- og udviklingstoksicitet hos cynomolgusaber ved doser på op til 50 mg/kg/uge (med eksponeringer på ca. 70 gange den kliniske eksponering ved den anbefalede humane maksimumdosis [MRHD]).
English: Enrolled subjects were 18 years of age and older with plaque psoriasis who had a body surface area (BSA) involvement of ≥10%, a static Physician Global Assessment (sPGA) score of ≥3 in the overall assessment (plaque thickness/induration, erythema, and scaling) of psoriasis on a severity scale of 0 to 4, a Psoriasis Area and Severity Index (PASI) score ≥12, and who were candidates for systemic therapy or phototherapy.
Danish: De inkluderede patienter var 18 år eller derover og havde plaquepsoriasis med en berørt legemsoverfladeareal (BSA) på ≥ 10 %, en sPGA-score (static Physician's Global Assessment) på ≥ 3 i den samlede vurdering af psoriasis (plaque-tykkelse/hærdning, erytem og afskalning) på en skala fra 0-4, en PASI-score (Psoriasis Area and Severity Index) på ≥ 12 og var kandidater til systemisk behandling eller lysterapi.
English: ADA/ADA: Subjects randomised to adalimumab and continued on adalimumab ADA/RZB: Subjects randomised to adalimumab and switched to risankizumab p<0.05 at week 4 and p<0.001 at each time point beginning at week 8
Danish: ADA/ADA: Patienter, der var randomiseret til adalimumab, og som fortsatte på adalimumab ADA/RZB: Patienter, der var randomiseret til adalimumab, og som skiftede til risankizumab p < 0,05 i uge 4 og p < 0,001 ved hvert tidspunkt fra og med uge 8
English: Important information to know before you inject Skyrizi
Danish: Vigtige oplysninger, som du skal læse, før du injicerer Skyrizi
English: Risankizumab is not expected to be metabolised by cytochrome P450 enzymes.
Danish: Risankizumab forventes ikke at blive metaboliseret af cytokrom P450-enzymer.
English: ULTIMMA-1 and ULTIMMA-2 enrolled 997 subjects (598 randomised to risankizumab 150 mg, 199 to ustekinumab 45 mg or 90 mg [according to baseline weight], and 200 to placebo).
Danish: ULTIMMA-1 og ULTIMMA-2 inkluderede 997 patienter (598 var randomiseret til risankizumab 150 mg, 199 til ustekinumab 45 mg eller 90 mg (ud fra baseline-vægt), og 200 var randomiseret til placebo).
English: The two co-primary endpoints in ULTIMMA-1 and ULTIMMA-2 were the proportion of subjects who achieved 1) PASI 90 response and 2) sPGA score of clear or almost clear (sPGA 0 or 1) at week 16 versus placebo.
Danish: De to co-primære endepunkter i ULTIMMA-1 og ULTIMMA-2 var andelen af patienter, der opnåede 1) PASI 90respons og 2) "clear" eller "almost clear" hud (sPGA-score på 0 eller 1) i uge 16 vs. placebo.
English: Each pack contains 2 pre-filled syringes and 2 alcohol pads.
Danish: Hver pakning indeholder 2 fyldte sprøjter og 2 spritservietter.
English: • your belly (abdomen) at least 5 cm from your belly button (navel)
Danish: • Maveregionen - mindst 5 cm fra navlen
English: For a more comfortable injection: Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for 15 to 30 minutes before injecting.
Danish: For at gøre opløsningen mindre kold: Tag æsken ud af køleskabet, og lad den ligge ved stuetemperatur i 15-30 minutter (må ikke ligge i direkte sollys) inden injektionen.
English: • Your doctor, pharmacist or nurse will tell you how to return the full special disposal container
Danish: • Lægen, apotekspersonalet eller sundhedspersonalet vil fortælle dig, hvordan du skal returnere beholderen til skarpe genstande, når den er fuld.
English: IMMVENT enrolled 605 subjects (301 randomised to risankizumab and 304 to adalimumab).
Danish: IMMVENT inkluderede 605 patienter (301 var randomiseret til risankizumab, og 304 var randomiseret til adalimumab).
English: Patients treated with risankizumab should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur.
Danish: Patienter behandlet med risankizumab skal have at vide, at de skal søge læge, hvis de oplever tegn eller symptomer på en klinisk væsentlig kronisk eller akut infektion.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with risankizumab in one or more subsets of the paediatric population in the treatment of plaque psoriasis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med risankizumab i en eller flere undergrupper af den pædiatriske population ved behandling af plaquepsoriasis (se pkt.
English: Please read all of section 7 before using Skyrizi
Danish: Du skal læse hele punkt 7, før du anvender Skyrizi
English: For subjects treated with risankizumab at the recommended clinical dose for up to 52 weeks in psoriasis clinical trials, treatment-emergent anti-drug antibodies and neutralising antibodies were detected in 24% (263/1,079) and 14% (150/1,079) of evaluated subjects, respectively.
Danish: For patienter, der blev behandlet med risankizumab i den anbefalede kliniske dosis i op til 52 uger i kliniske psoriasis-studier, blev behandlingsrelaterede anti-drug-antistoffer og neutraliserende antistoffer detekteret hos hhv. 24 % (263/1.079) og 14 % (150/1.079) af de undersøgte patienter.
English: Examination of age, gender, race, body weight ≤130 kg, baseline PASI score, concurrent psoriatic arthritis, previous non-biologic systemic treatment, previous biologic treatment, and previous failure of a biologic did not identify differences in response to risankizumab among these subgroups.
Danish: Ved undersøgelse af alder, køn, etnisk oprindelse, legemsvægt ≤130 kg, PASI-score ved baseline, samtidig psoriasisgigt, tidligere ikke-biologisk systemisk behandling, tidligere biologisk behandling og tidligere svigt af biologisk behandling sås ingen forskelle i respons over for risankizumab hos delgrupperne.
English: Common: may affect up to 1 in 10 people
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter):
English: You and your doctor, pharmacist or nurse will decide if you should inject this medicine yourself.
Danish: Lægen, apotekspersonalet, eller sygeplejersken vil drøfte med dig, om du selv skal injicere lægemidlet.
English: • 2 pre-filled syringes and 2 alcohol pads (included in the carton)
Danish: • 2 fyldte sprøjter og 2 spritservietter (medfølger i æsken)
English: • if you are using, have recently used or might use any other medicines.
Danish: • du bruger anden medicin eller har gjort det for nylig
English: This medicinal product contains 68.0 mg sorbitol per 150 mg dose.
Danish: Dette lægemiddel indeholder 68,0 mg sorbitol pr. dosis på 150 mg.
English: Patients should be instructed to inject 2 pre-filled syringes for the full 150 mg dose and to read the ‘Instructions for use' provided in the package leaflet before administration.
Danish: Patienterne skal have at vide, at de skal injicere indholdet af 2 fyldte sprøjter for at få den fulde dosis på 150 mg, og at de skal læse indlægssedlens brugsvejledning før administration.
English: Population pharmacokinetic analyses indicated that risankizumab exposure was not impacted by concomitant medications (metformin, atorvastatin, lisinopril, amlodipine, ibuprofen, acetylsalicylate and levothyroxine) used by some subjects with plaque psoriasis during the clinical studies.
Danish: Farmakokinetiske populationsanalyser viste, at risankizumab-eksponeringen ikke blev påvirket af samtidigt administrerede lægemidler (metformin, atorvastatin, lisinopril, amlodipin, ibuprofen, acetylsalicylsyre og levothyroxin), som nogle patienter med plaque-psoriasis anvendte under de kliniske studier.
English: Excipients: disodium succinate hexahydrate, succinic acid, sorbitol, polysorbate 20 and water for injections.
Danish: Hjælpestoffer: dinatriumsuccinathexahydrat, ravsyre, sorbitol, polysorbat 20 og vand til injektionsvæsker.
English: In a 26-week chronic toxicology study in cynomolgus monkeys at doses of up to 50 mg/kg/week (about 70 times the clinical exposure at the MRHD), there were no pre-neoplastic or neoplastic lesions observed and no adverse immunotoxicity or cardiovascular effects were noted .
Danish: I et 26-ugers studie af kronisk toksikologi hos cynomolgusaber ved doser på op til 50 mg/kg/uge (ca. 70 gange den kliniske eksponering ved den anbefalede humane maksimumdosis (MRHD)) sås der ingen præneoplastiske eller neoplastiske læsioner, ligesom der ikke sås nogen immuntoksiske eller kardiovaskulære bivirkninger.
English: No clinically meaningful differences in risankizumab exposure were observed in Chinese or Japanese subjects compared to Caucasian subjects in a clinical pharmacokinetic study.
Danish: Der er ikke set relevante kliniske forskelle i risankizumab-eksponering hos kinesiske og japanske patienter sammenholdt med kaukasiske patienter i kliniske studier af farmakokinetikken.