FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Med preiskovanci, zdravljenimi z risankizumabom v priporočenih kliničnih odmerkih do 52 tednov v kliničnih preskušanjih pri psoriazi so med zdravljenjem ugotovili nastanek protiteles proti zdravilu pri 24 % (263/1 079) in nevtralizirajočih protiteles pri 14 % (150/1 079) ovrednotenih preiskovancev.
English: Risankizumab has no or negligible influence on the ability to drive and use machines.
Slovenian: Risankizumab nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: sPGA of clear or almost clear PASI 75
Slovenian: Ocena sPGA čista ali skoraj čista
English: • Do not throw away used syringes in the household waste
Slovenian: • Uporabljenih injekcijskih brizg ne smete odvreči med gospodinjske odpadke.
English: Skyrizi contains sorbitol and sodium This medicine contains 68 mg sorbitol per 150 mg dose.
Slovenian: Zdravilo Skyrizi vsebuje sorbitol in natrij To zdravilo vsebuje 68 mg sorbitola na 150-mg odmerek.
English: Skyrizi is administered by subcutaneous injection.
Slovenian: Zdravilo Skyrizi se uporablja s subkutanim injiciranjem.
English: Excipients: disodium succinate hexahydrate, succinic acid, sorbitol, polysorbate 20 and water for injections.
Slovenian: Pomožne snovi: dinatrijev sukcinat heksahidrat, sukcinska kislina, sorbitol, polisorbat 20 in voda za injekcije.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 150 mg dose, that is to say essentially ‘sodium free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 150-mg odmerek; to pomeni, da je praktično "brez natrija".
English: Risankizumab exhibited linear pharmacokinetics with dose-proportional increase in exposure across dose ranges of 18 to 300 mg and 0.25 to 1 mg/kg administered subcutaneously, and 200 to 1,200 mg and 0.01 to 5 mg/kg administered intravenously.
Slovenian: Risankizumab je imel linearno farmakokinetiko z odmerku sorazmernim povečanjem izpostavljenosti v razponu odmerkov od 18 do 300 mg in od 0,25 do 1 mg/kg subkutano ter od 200 do 1200 mg in od 0,01 do 5 mg/kg intravensko.
English: Skyrizi is not recommended for children and adolescents under 18 years of age.
Slovenian: Zdravilo Skyrizi ni priporočljivo za otroke in mladostnike, mlajše od 18 let, ker v tej starostni skupini ni raziskano.
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
Slovenian: ADA/RZB: Preiskovanci, randomizirani na adalimumab, ki so prešli na risankizumab p < 0,05 4. teden in p < 0,001 na vseh časovnih točkah, začenši z 8. tednom
English: Week 52 262 (86.2) sPGA of clear (0) Week 16 112 (36.8) Week 52 175 (57.6) PASI 75
Slovenian: 52. teden 262 (86,2) Ocena sPGA čisto (0) 16. teden 112 (36,8) 52. teden 175 (57,6) PASI 75
English: In a study of subjects with psoriasis, expression of genes associated with the IL-23/IL-17 axis was decreased in the skin after single doses of risankizumab.
Slovenian: V študiji preiskovancev s psoriazo se je v koži izraženost genov, povezanih z osjo IL-23/IL-17, zmanjšala že po enkratnih odmerkih risankizumaba.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: There is limited information in subjects aged ≥65 years.
Slovenian: Podatki pri preiskovancih, starih ≥ 65 let, so omejeni.
English: Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds with high affinity to the p19 subunit of human interleukin 23 (IL-23) cytokine without binding to IL12 and inhibits its interaction with the IL-23 receptor complex.
Slovenian: Risankizumab je humaniziran imunoglobulin G1 (IgG1), monoklonsko protitelo, ki se selektivno in z visoko afiniteto veže na podenoto p19 človeškega citokina interlevkina 23 (IL-23), brez vezave na IL12, ter zavre njegovo medsebojno delovanje z receptorskim kompleksom IL-23.
English: Table 2: Efficacy and quality of life results in adults with plaque psoriasis in ULTIMMA-1 and ULTIMMA-2
Slovenian: Preglednica 2: Rezultati učinkovitosti in kakovosti življenja pri odraslih s psoriazo v plakih v študijah ULTIMMA-1 in ULTIMMA-2
English: Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody selective to the interleukin (IL)-23 protein produced in Chinese Hamster Ovary cells using recombinant DNA technology.
Slovenian: Risankizumab je humaniziran imunoglobulin G1 (IgG1), monoklonsko protitelo, selektivno za beljakovino interlevkin (IL)-23; pridobljen je s tehnologijo rekombinantne DNA v celicah jajčnikov kitajskega hrčka.
English: solution for injection 2 pre-filled syringes 2 alcohol pads
Slovenian: raztopina za injiciranje 2 napolnjeni injekcijski brizgi 2 alkoholna zloženca
English: Before each injection, wipe where you will inject in a circular motion with an alcohol pad.
Slovenian: Pred vsakim injiciranjem s krožnim gibom z alkoholnim zložencem obrišite mesto, kamor boste injicirali.
English: A caregiver may also give your injections after they have been trained.
Slovenian: Injekcije vam lahko daje tudi oseba, ki za vas skrbi (vaš negovalec), potem ko se za to usposobi.
English: If you are not sure, talk to your doctor, pharmacist or nurse before and during the use of Skyrizi.
Slovenian: Če ste negotovi, se pred uporabo in med uporabo zdravila Skyrizi posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
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.
Slovenian: Pri preiskovancih s psoriazo v plakih so izvedli študijo medsebojnega delovanja zdravil za oceno vpliva ponavljajoče se uporabe risankizumaba na farmakokinetiko testnih substratov, občutljivih za citokrom P450 (CYP).
English: The dose is 150 mg given as two 75 mg injections.
Slovenian: Odmerek je 150 mg in se ga uporabi v dveh 75-mg injekcijah.
English: As an IgG1 monoclonal antibody, risankizumab is not expected to be filtered by glomerular filtration in the kidneys or to be excreted as an intact molecule in the urine.
Slovenian: Risankizumab je monoklonsko protitelo IgG1, zato ni pričakovati, da bi se v ledvicah filtriral z glomerulno filtracijo ali da bi se izločal v urinu kot intaktna molekula.
English: What you need to know before you use Skyrizi
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Skyrizi
English: For the second syringe, inject at least 3 cm away from the first injection.
Slovenian: Z drugo injekcijsko brizgo injicirajte vsaj 3 cm proč o mesta, kamor ste dali prvo injekcijo.
English: You should not be given certain types of vaccines while using Skyrizi.
Slovenian: Med uporabo zdravila Skyrizi ne smete dobiti določenih vrst cepiv.
English: Change at Week 52 (SE)
Slovenian: Sprememba v 52. tednu (SN)
English: • Keep the syringes in the carton until ready to inject
Slovenian: • Injekcijske brizge shranjujte v škatli, dokler niste pripravljeni za injiciranje.
English: Keep the syringe steady at the same angle.
Slovenian: Injekcijsko brizgo mirno držite pod istim kotom.
English: Week 12 264 (86.8) Week 52 279 (91.8) PASI 90
Slovenian: 12. teden 264 (86,8) 52. teden 279 (91,8) PASI 90
English: If you forget to use Skyrizi
Slovenian: Če ste pozabili uporabiti zdravilo Skyrizi
English: For PASI 90 responders at week 16, 88.4% (398/450) of subjects maintained the response at week 52.
Slovenian: Med preiskovanci z odzivom PASI 90 v 16. tednu se je odziv v 52. tednu ohranil pri 88,4 % (398/450).
English: Place the following items on a clean, flat surface:
Slovenian: Na čisto, ravno površino položite:
English: By blocking IL-23 from binding to its receptor, risankizumab inhibits IL-23-dependent cell signalling and release of proinflammatory cytokines.
Slovenian: Z blokado vezave IL-23 na njegov receptor risankizumab zavre od IL-23 odvisno celično signaliziranje in sproščanje vnetnih citokinov.
English: • if the syringe paper tray cover is broken or missing
Slovenian: • če je papirnat podstavek injekcijske brizge poškodovan ali manjka.
English: • if the syringe has been dropped or damaged
Slovenian: • če je injekcijska brizga kam padla ali se poškodovala,
English: • 2 cotton balls or gauze pads (not included in the carton)
Slovenian: • 2 kosma vate ali zloženca gaze (nista priložena v škatli)
English: Based on population pharmacokinetic analyses, serum creatinine levels, creatinine clearance, or hepatic function markers (ALT/AST/bilirubin) did not have a meaningful impact on risankizumab clearance in subjects with psoriasis.
Slovenian: Na podlagi populacijskih farmakokinetičnih analiz koncentracija kreatinina v serumu, očistek kreatinina ali označevalci jetrne funkcije (ALT/AST/bilirubin) pri preiskovancih s psoriazo niso pomembno vplivali na očistek risankizumaba.
English: This medicinal product contains 68.0 mg sorbitol per 150 mg dose.
Slovenian: To zdravilo vsebuje 68,0 mg sorbitola na 150-mg odmerek.
English: The recommended dose is 150 mg (two 75 mg injections) administered by subcutaneous injection at week 0, week 4, and every 12 weeks thereafter.
Slovenian: Priporočeni odmerek je 150 mg (dve 75-mg injekciji) v subkutani injekciji 0. teden, 4. teden in nato vsakih 12 tednov.
English: Subjects received treatment at week 0, week 4 and every 12 weeks thereafter.
Slovenian: Preiskovanci so dobili zdravilo 0. teden, 4. teden in nato vsakih 12 tednov.
English: For subjects who had PASI 50 to <PASI 90 with adalimumab at week 16 and were re-randomised, differences in PASI 90 response rates between switching to risankizumab and continuing adalimumab were noted 4 weeks after re-randomisation (49.1% vs 26.8%, respectively).
Slovenian: Pri preiskovancih, ki so imeli ob uporabi adalimumaba v 16. tednu oceno PASI od 50 do < 90 in so bili nato ponovno randomizirani, je bila razlika v deležu odziva PASI 90 med tistimi, ki so prešli na risankizumab in tistimi, ki so nadaljevali z adalimumabom, opazna 4 tedne po ponovni randomizaciji (49,1 % z risankizumabom in 26,8 % z adalimumabom).
English: Each pack contains 2 pre-filled syringes and 2 alcohol pads.
Slovenian: V vsakem pakiranju sta 2 napolnjeni injekcijski brizgi in 2 alkoholna zloženca.
English: At week 16, risankizumab was superior to placebo on the co-primary endpoints of sPGA of clear or almost clear (83.5% risankizumab vs 7.0% placebo) and PASI 90 (73.2% risankizumab vs 2.0% placebo).
Slovenian: V 16. tednu je bil risankizumab superioren placebu, kar zadeva soprimarna opazovana dogodka sPGA čisto ali skoraj čisto (83,5 % z risankizumabom in 7,0 % s placebom) in PASI 90 (73,2 % z risankizumabom in 2,0 % s placebom).
English: ULTIMMA-1 and ULTIMMA-2
Slovenian: ULTIMMA-1 in ULTIMMA-2
English: Risankizumab is not expected to be metabolised by cytochrome P450 enzymes.
Slovenian: Ni pričakovati, da bi se risankizumab presnavljal z encimi citokroma P450.
English: What Skyrizi looks like and contents of the pack Skyrizi is a clear and colourless to slightly yellow liquid in a pre-filled syringe with needle guard.
Slovenian: Izgled zdravila Skyrizi in vsebina pakiranja Zdravilo Skyrizi je bistra in brezbarvna do rumenkasta tekočina v napolnjeni injekcijski igli s ščitnikom igle.
English: Keep the pre-filled syringes in the original carton in order to protect from light.
Slovenian: Napolnjene injekcijske brizge shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: Table 3: Mean changes from baseline in NAPSI, PPASI, and PSSI ULTIMMA-1
Slovenian: Preglednica 3: Povprečne spremembe od izhodiščne vrednosti pri NAPSI, PPASI in PSSI ULTIMMA-1
English: Other medicines and Skyrizi
Slovenian: Druga zdravila in zdravilo Skyrizi
English: For subcutaneous use
Slovenian: za subkutano uporabo
English: There is no relevant use of Skyrizi in children aged below 6 years for the indication of moderate to severe plaque psoriasis.
Slovenian: Pri otrocih, mlajših od 6 let, zdravilo Skyrizi nima relevantne uporabe za indikacijo zmerne do hude psoriaze v plakih.
English: Driving and using machines Skyrizi is not likely to affect your driving and use of machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Skyrizi vplivalo na vašo sposobnost upravljanja vozil ali strojev.
English: Skyrizi is available in packs containing 2 pre-filled syringes and 2 alcohol pads.
Slovenian: Zdravilo Skyrizi je na voljo v pakiranjih, ki vsebujejo 2 napolnjeni injekcijski brizgi in 2 alkoholna zloženca.
English: How much Skyrizi to use
Slovenian: Koliko zdravila Skyrizi uporabiti
English: - The other ingredients are disodium succinate hexahydrate, succinic acid, sorbitol, polysorbate
Slovenian: - Druge sestavine zdravila so dinatrijev sukcinat heksahidrat, sukcinska kislina, sorbitol,
English: Co-primary endpoints versus placebo No impact on health-related quality of life c Psoriasis Symptom Scale (PSS) of 0 means no symptoms of pain, itching, redness, and burning during the last 24 hours
Slovenian: c Lestvica simptomov psoriaze (Psoriasis Symptom Scale, PSS) 0 pomeni, da ni simptomov bolečine, srbenja, pordelosti in pekočega občutka v zadnjih 24 urah.
English: Choose from these 3 areas to inject:
Slovenian: Za injiciranje izberite enega izmed 3 predelov:
English: • your belly (abdomen) at least 5 cm from your belly button (navel)
Slovenian: • trebuh, vendar najmanj 5 cm proč od popka
English: The liquid may contain tiny white or clear particles.
Slovenian: Tekočina lahko vsebuje drobne bele ali prozorne delce.
English: The mean (±standard deviation) systemic clearance (CL) of risankizumab was 0.3 (±0.1) L/day in Phase 3 studies in subjects with psoriasis.
Slovenian: Povprečni (± standardni odklon) sistemski očistek (CL) risankizumaba je bil v študijah 3. faze pri preiskovancih s psoriazo 0,3 (± 0,1) l/dan.
English: Figure 1: Time course of mean percent change from baseline of PASI in ULTIMMA-1 and ULTIMMA-2
Slovenian: Slika 1: Časovni potek povprečne odstotne spremembe PASI od izhodišča v študijah ULTIMMA-1 in ULTIMMA-2
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.
Slovenian: Soprimarna opazovana dogodka v študijah ULTIMMA-1 in ULTIMMA-2 sta bila deleža bolnikov, ki so po v 16. tednu v primerjavi s placebom dosegli (1) odziv PASI 90 in (2) oceno sPGA čisto ali skoraj čisto (sPGA 0 ali 1).
English: • Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks
Slovenian: • Ne injicirajte v kožo, ki je ranjena, podpluta, pordela, zatrdela, zabrazgotinjena ali so na njej strije.
English: In an integrated analysis of subjects receiving risankizumab in ULTIMMA-1 and ULTIMMA-2 for PASI 100 responders at week 16, 79.8% (206/258) of the subjects who continued on risankizumab maintained the response at week 52.
Slovenian: V združeni analizi preiskovancev, ki so prejemali risankizumab v študijah ULTIMMA-1 in ULTIMMA-2 in so imeli v 16. tednu odziv PASI 100 , se je pri preiskovancih, ki so nadaljevali zdravljenje z risankizumabom, odziv v 52. tednu ohranil pri 79,8 % (206/258).
English: As an IgG1 monoclonal antibody, risankizumab is mainly eliminated via intracellular catabolism and is not expected to undergo metabolism via hepatic cytochrome P450 enzymes or renal elimination.
Slovenian: Risankizumab je monoklonsko protitelo IgG1 in se v glavnem odstrani z znotrajcelično razgradnjo ter ni pričakovati, da bi bil podvržen presnovi z jetrnimi encimi citokroma P450 ali izločanju skozi ledvice.
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.
Slovenian: Če se bolniku pojavi takšna okužba, ali če se ne odzove na običajno zdravljenje okužbe, ga je potrebno skrbno nadzirati.
English: • difficulty breathing or swallowing
Slovenian: • težko dihanje ali požiranje,
English: The mean (±standard deviation) steady-state volume of distribution (Vss) of risankizumab was 11.4 (±2.7) L in Phase 3 studies in subjects with psoriasis, indicating that the distribution of risankizumab is primarily confined to the vascular and interstitial spaces.
Slovenian: V študijah 3. faze je bil povprečni (± standardni odklon) volumen porazdelitve risankizumaba v stanju dinamičnega ravnovesja (Vss) pri preiskovancih s psoriazo 11,4 (± 2,7) l; to kaže, da je porazdelitev risankizumaba v prvi vrsti omejena na žilni in intersticijski prostor.
English: Do not inject yourself with this medicine unless you have been trained by your doctor, pharmacist or nurse.
Slovenian: Zdravila si ne injicirajte, dokler vas zdravnik, farmacevt ali medicinska sestra ne nauči, kako to naredite.
English: Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Str. 65
Slovenian: Boehringer Ingelheim Pharma GmbH & Co.
English: Read section 7 ‘Instructions for use' at the end of this leaflet before injecting Skyrizi yourself.
Slovenian: Preden si zdravilo Skyrizi injicirate sami, preberite poglavje 7, "Navodila za uporabo", na koncu tega navodila.
English: • if you have recently had or are going to have a vaccination.
Slovenian: • če ste se pred kratkim cepili ali imate predvideno kakšno cepljenje.
English: The solution is colourless to slightly yellow and clear to slightly opalescent.
Slovenian: Raztopina je brezbarvna do rahlo rumenkasta in bistra do rahlo opalescentna.
English: PASI Percent Change from Baseline
Slovenian: Odstotek spremembe PASI od izhodišča
English: • Throw away the needle cover
Slovenian: • Pokrovček igle zavrzite.
English: • The liquid should look clear to slightly yellow and may contain tiny white or clear particles
Slovenian: • Tekočina mora biti bistra do rumenkasta in lahko vsebuje drobne bele ali prozorne delce.
English: It is unknown whether risankizumab is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo risankizumab izloča v materino mleko.
English: Other side effects Tell your doctor, pharmacist or nurse if you get any of the following side effects
Slovenian: Obvestite zdravnika, farmacevta ali medicinsko sestro, če se vam pojavi kateri od naslednjih neželenih učinkov
English: No specific studies have been conducted to determine the effect of renal or hepatic impairment on the pharmacokinetics of risankizumab.
Slovenian: Specifičnih študij za ugotavljanje vpliva okvare ledvic ali jeter na farmakokinetiko risankizumaba niso izvedli.
English: The solution should be colourless to slightly yellow and clear to slightly opalescent.
Slovenian: Raztopina mora biti brezbarvna do rahlo rumenkasta in bistra do rahlo opalescentna.
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.
Slovenian: Aktivna tuberkuloza (TB) se med povprečno 55-tedenskim spremljanjem zdravljenja z risankizumabom ni pojavila pri nobenem od 31 preiskovancev v študiji IMMHANCE, ki so imeli latentno tuberkulozo (TB) in med študijo niso prejemali profilakse.
English: Two pre-filled syringes should be injected for the full 150 mg dose.
Slovenian: Za celoten 150-mg odmerek je treba injicirati dve napolnjeni injekcijski brizgi.
English: Week 16 109 (35.9) Week 52 171 (56.3) DLQI 0 or 1
Slovenian: 16. teden 109 (35,9) 52. teden 171 (56,3)
English: • Do not inject if the liquid is cloudy or contains flakes or large particles.
Slovenian: • Ne injicirajte, če je tekočina motna ali vsebuje kosme ali velike delce.
English: No clinically meaningful differences in risankizumab exposure were observed in Chinese or Japanese subjects compared to Caucasian subjects in a clinical pharmacokinetic study.
Slovenian: V klinični študiji farmakokinetike niso ugotovili klinično pomembnih razlik v izpostavljenosti risankizumabu pri kitajskih ali japonskih preiskovancih v primerjavi z belci.
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se s posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: 2D barcode carrying the unique identifier included.
Slovenian: <Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako>.
English: Body of syringe
Slovenian: Telo injekcijske brizge
English: If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.
Slovenian: Če dojite ali nameravate dojiti, se posvetujte z zdravnikom, preden uporabite to zdravilo.
English: Among subjects with sPGA of clear or almost clear at week 28 in IMMHANCE, 81.1% (90/111) of subjects re-randomised to continued treatment with risankizumab maintained this response at week 104 compared to 7.1% (16/225) who were re-randomised to withdrawal from risankizumab.
Slovenian: Med preiskovanci, ki so imeli v študiji IMMHANCE v 28. tednu sPGA čisto ali skoraj čisto in so jih ponovno randomizirali na nadaljevanje zdravljenja z risankizumabom, se je ta odziv v 104. tednu ohranil pri 81,1 % (90/111) preiskovancev; med tistimi, ki so bili ob ponovni randomizaciji razvrščeni na prenehanje zdravljenja, pa je bil ta delež 7,1 % (16/225).
English: • You should receive training on how to inject Skyrizi before giving an injection.
Slovenian: • Preden boste injicirali zdravilo Skyrizi, morate za to opraviti usposabljanje.
English: Risankizumab exhibited linear pharmacokinetics with approximately dose-proportional increases in systemic exposure (Cmax and AUC) in the evaluated dose ranges of 18 to 300 mg or 0.25 to 1 mg/kg subcutaneous administration in healthy subjects or subjects with psoriasis.
Slovenian: Pri zdravih preiskovancih in preiskovancih s psoriazo je imel risankizumab linearno farmakokinetiko s približno odmerku sorazmernim povečanjem sistemske izpostavljenosti (Cmax in AUC) v ocenjenem razponu odmerkov od 18 do 300 mg ali od 0,25 do 1 mg/kg subkutano.
English: Subjects randomised to risankizumab received 150 mg of treatment at week 0, week 4 and every 12 weeks thereafter.
Slovenian: Preiskovanci, randomizirani na risankizumab, so prejeli 150 mg zdravila 0. teden, 4. teden in nato vsakih 12 tednov.
English: The liquid should look clear to slightly yellow and may contain tiny white or clear particles
Slovenian: Tekočina mora biti bistra do rumenkasta in lahko vsebuje drobne bele ali prozorne delce.
English: No specific studies were conducted to assess the effect of hepatic or renal impairment on the pharmacokinetics of Skyrizi.
Slovenian: Specifičnih študij za oceno vpliva okvare jeter ali ledvic na farmakokinetiko zdravila Skyrizi niso izvedli.
English: Skyrizi is used to treat adults with moderate to severe plaque psoriasis.
Slovenian: Zdravilo Skyrizi uporabljamo za zdravljenje odraslih, ki imajo zmerno do hudo psoriazo v plakih.
English: The pharmacokinetics of risankizumab in paediatric subjects has not been established.
Slovenian: Farmakokinetika risankizumaba pri pediatričnih preiskovancih ni ugotovljena.
English: Of these subjects, 63.1% (70/111) of subjects re-randomised to continued treatment with risankizumab achieved a sPGA clear response at week 104 compared to 2.2% (5/225) who were re-randomised to withdrawal from risankizumab.
Slovenian: Od teh preiskovancev, ki so bili ponovno randomizirani na nadaljevanje zdravljenja z risankizumabom, jih je v 104. tednu 63,1 % (70/111) doseglo odziv sPGA čisto; med tistimi, ki so bili ob ponovni randomizaciji razvrščeni na prenehanje zdravljenja, pa je bil ta delež 2,2 % (5/225).