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.
Croatian: Među ispitanicima liječenima risankizumabom u preporučenoj kliničkoj dozi tijekom najviše 52 tjedna u kliničkim ispitivanjima primjene kod psorijaze, protutijela na lijek i neutralizirajuća protutijela koja su se javila tijekom liječenja pronađena su u 24% (263/1079) odnosno 14% (150/1079) ocijenjenih ispitanika.
English: Week 16 200 (65.8) Week 52 229 (75.3) PSS 0 (symptom-free)
Croatian: 16. tjedan 200 (65,8) 52. tjedan 229 (75,3) PSS 0 (bez simptoma)
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.
Croatian: Prema populacijskim farmakokinetičkim analizama, razine serumskog kreatinina, klirens kreatinina ili biljezi jetrene funkcije (ALT/AST/bilirubin) nisu značajno utjecali na klirens risankizumaba u ispitanika s psorijazom.
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.
Croatian: U ispitanika s plak psorijazom provedeno je ispitivanje interakcija s drugim lijekovima radi ocjene učinka ponovljene primjene risankizumaba na farmakokinetiku probnih supstrata osjetljivih na citokrom P450 (CYP).
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment.
Croatian: U bolesnika koji ne ostvare nikakav odgovor nakon 16 tjedana liječenja potrebno je razmotriti prekid liječenja.
English: It also reduces symptoms of psoriasis such as burning, itching, pain, redness and scaling.
Croatian: Uz to ublažava i simptome psorijaze kao što su žarenje, svrbež, bol, crvenilo i ljuskanje kože.
English: Subjects who were originally on risankizumab and had a sPGA response of clear or almost clear at week 28 were rerandomised to continue risankizumab every 12 weeks or have treatment withdrawn.
Croatian: Ispitanici kojima je izvorno dodijeljeno liječenje risankizumabom i koji su u 28. tjednu imali sPGA odgovor „čisto“ ili „gotovo čisto“ ponovnom su randomizacijom svrstani u skupinu koja je nastavila liječenje risankizumabom svakih 12 tjedana ili u skupinu koja je prekinula liječenje.
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
Croatian: ADA/RZB: Ispitanici randomizirani za liječenje adalimumabom koji su prešli na risankizumab p<0,05 u 4. tjednu i p<0,001 u svakoj vremenskoj točki počevši od 8. tjedna
English: solution for injection 2 pre-filled syringes 2 alcohol pads
Croatian: otopina za injekciju 2 napunjene štrcaljke 2 jastučića natopljena alkoholom
English: Insert the needle all the way into the skin at about a 45-degree angle using a quick, short movement.
Croatian: Brzim i naglim pokretom ubodite iglu punom duljinom u kožu pod kutom od približno 45 stupnjeva.
English: • With the other hand, gently pull the needle cover straight off
Croatian: • Drugom rukom nježno povucite pokrov ravno s igle.
English: QR code to be included
Croatian: Uključiti QR kôd
English: Keep the pre-filled syringes in the original carton in order to protect from light.
Croatian: Napunjene štrcaljke čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: Subjects received treatment at week 0, week 4 and every 12 weeks thereafter.
Croatian: Ispitanici su primili terapiju u 0. tjednu i 4. tjednu, a zatim svakih 12 tjedana.
English: • if you have recently had or are going to have a vaccination.
Croatian: • ako ste nedavno primili ili ćete primiti neko cjepivo.
English: Excipients: disodium succinate hexahydrate, succinic acid, sorbitol, polysorbate 20 and water for injections.
Croatian: Pomoćne tvari: dinatrijev sukcinat heksahidrat, sukcinatna kiselina, sorbitol, polisorbat 20 i voda za injekcije.
English: IMMHANCE enrolled 507 subjects (407 randomised to risankizumab 150 mg and 100 to placebo).
Croatian: U ispitivanje IMMHANCE bilo je uključeno 507 ispitanika (407 ih je bilo randomizirano za liječenje risankizumabom u dozi od 150 mg, a 100 za primanje placeba).
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva često pruritus
English: Risankizumab is not expected to be metabolised by cytochrome P450 enzymes.
Croatian: Ne očekuje se metabolizam risankizumaba djelovanjem enzima citokroma P450.
English: The liquid may contain tiny white or clear particles.
Croatian: Tekućina može sadržavati sitne bijele ili prozirne čestice.
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.
Croatian: Kao IgG1 monoklonsko protutijelo, risankizumab se pretežno eliminira unutarstaničnim katabolizmom, pa se ne očekuje njegov metabolizam putem jetrenih enzima citokroma P450 ni eliminacija kroz bubrege.
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.
Croatian: Uključeni ispitanici imali su 18 ili više godina, plak psorijazu koja je zahvaćala ≥10% tjelesne površine, rezultat prema statičnoj općoj ocjeni liječnika (engl. static Physician Global Assessment, sPGA) ≥3 u ukupnoj ocjeni (debljina/otvrdnuće plaka, eritem i ljuskanje) psorijaze na ljestvici težine od 0 do 4, rezultat indeksa proširenosti i težine psorijaze (engl.
English: The mean terminal elimination half-life of risankizumab ranged from 28 to 29 days in Phase 3 studies in subjects with psoriasis.
Croatian: Srednja vrijednost terminalnog poluvijeka eliminacije risankizumaba među ispitanicima s psorijazom u ispitivanjima faze 3 kretala se između 28 i 29 dana.
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).
Croatian: Risankizumab je u 16. tjednu bio superioran placebu s obzirom na koprimarne mjere ishoda - sPGA rezultat „čisto“ ili „gotovo čisto“ (83,5% uz risankizumab naspram 7,0% uz placebo) i odgovor PASI 90 (73,2% uz risankizumab naspram 2,0% uz placebo).
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.
Croatian: Risankizumab je pokazao linearnu farmakokinetiku i povećanje izloženosti proporcionalno dozi u rasponu doza od 18 do 300 mg te od 0,25 do 1 mg/kg kod supkutane primjene odnosno od 200 do 1200 mg te od 0,01 do 5 mg/kg kod intravenske primjene.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 150 mg dose, that is to say essentially ‘sodium free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi od 150 mg, tj. zanemarive količine natrija.
English: The dose is 150 mg given as two 75 mg injections.
Croatian: Doza iznosi 150 mg, a primjenjuje se u dvije injekcije od 75 mg.
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.
Croatian: Prema analizi objedinjenih podataka prikupljenih u ispitanika koji su primali risankizumab u ispitivanjima ULTIMMA-1 i ULTIMMA-2 koji su u 16. tjednu imali odgovor PASI 100, u 79,8% (206/258) onih koji su nastavili primati risankizumab taj se odgovor održao i u 52. tjednu.
English: Areas to inject
Croatian: Područja za injiciranje
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.
Croatian: Risankizumab je pokazao linearnu farmakokinetiku uz povećanja sistemske izloženosti (Cmax i AUC) približno proporcionalna dozi kod supkutane primjene ispitivanih doza u rasponu od 18 do 300 mg ili od 0,25 do 1 mg/kg u zdravih ispitanika ili ispitanika s psorijazom.
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).
Croatian: Među ispitanicima koji su uz adalimumab u 16. tjednu postigli odgovor između PASI 50 i <PASI 90 i koji su zatim bili ponovno randomizirani, razlike u stopama odgovora PASI 90 između onih koji su prešli na risankizumab i onih koji su nastavili liječenje adalimumabom bile su primjetne već 4 tjedna nakon ponovne randomizacije (49,1% naspram 26,8%).
English: What you need to know before you use Skyrizi
Croatian: Što morate znati prije nego počnete primjenjivati Skyrizi
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.
Croatian: Za risankizumab kao IgG1 monoklonsko protutijelo, ne očekuje se filtriranje glomerularnom filtracijom u bubrezima niti izlučivanje u obliku neizmijenjene molekule u mokraću.
English: • if you have recently received or plan to receive an immunisation (vaccine).
Croatian: • ako ste nedavno primili ili planirate primiti neko cjepivo.
English: Ltd Τηλ: +357 22 34 74 40
Croatian: Lifepharma (Z.A.M.) Ltd Τηλ: +357 22 34 74 40
English: • severe itching of the skin, with a red rash or raised bumps
Croatian: • jak svrbež kože praćen crvenim osipom ili uzdignutim kvržicama
English: Reductions in epidermal thickness, infiltration of inflammatory cells, and expression of psoriatic disease markers were also observed in psoriatic lesions.
Croatian: U psorijatičnim je lezijama opaženo i smanjenje debljine epiderme, infiltracije upalnih stanica i ekspresije biljega psorijatične bolesti.
English: Talk to your doctor, pharmacist or nurse before and during the use of Skyrizi:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije i tijekom liječenja lijekom Skyrizi:
English: LABEL
Croatian: OZNAČIVANJE
English: Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection.
Croatian: Prije uvođenja liječenja risankizumabom potrebno je utvrditi imaju li bolesnici tuberkulozu.
English: Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Str. 65
Croatian: Boehringer Ingelheim Pharma GmbH & Co.
English: How to use Skyrizi
Croatian: Kako čuvati Skyrizi
English: Overall, subjects had a median baseline PASI score of 17.8, a median BSA of 20.0%, and a median baseline DLQI score of 13.0.
Croatian: Sveukupno je među ispitanicima medijan početnog PASI rezultata iznosio 17,8 bodova, medijan zahvaćenosti tjelesne površine 20,0% i medijan početnog DLQI (engl.
English: The clearance of risankizumab was not significantly influenced by gender or race in adult subjects with plaque psoriasis.
Croatian: Spol ili rasa nisu značajno utjecali na klirens risankizumaba u odraslih ispitanika s plak psorijazom.
English: Anxiety and depression, as measured by the Hospital Anxiety and Depression Scale (HADS), improved in the risankizumab group at week 16 compared with the placebo group.
Croatian: Hospital Anxiety and Depression Scale, HADS), u odnosu na skupinu koja je primala placebo.
English: Other medicines and Skyrizi
Croatian: Drugi lijekovi i Skyrizi
English: Risankizumab has no or negligible influence on the ability to drive and use machines.
Croatian: Risankizumab ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Skyrizi is used to treat adults with moderate to severe plaque psoriasis.
Croatian: Skyrizi se koristi za liječenje odraslih osoba s umjerenom do teškom plak psorijazom.
English: • front of right thigh
Croatian: • prednji dio desnog bedra
English: Body of syringe
Croatian: Tijelo štrcaljke
English: Subjects randomised to adalimumab received 80 mg at week 0, 40 mg at week 1 and 40 mg every other week through week 15.
Croatian: Ispitanici randomizirani za liječenje adalimumabom primili su dozu od 80 mg u 0. tjednu i dozu od 40 mg u 1. tjednu, a zatim dozu od 40 mg svaki drugi tjedan do 15. tjedna.
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.
Croatian: Srednja vrijednost (±standardno odstupanje) volumena distribucije risankizumaba u stanju dinamičke ravnoteže (Vss) među ispitanicima s psorijazom u ispitivanjima faze 3 iznosila je 11,4 (±2,7) l, što ukazuje na to da je distribucija risankizumaba prvenstveno ograničena na krvožilni i intersticijski prostor.
English: Driving and using machines Skyrizi is not likely to affect your driving and use of machines.
Croatian: Nije vjerojatno da će Skyrizi utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: One pre-filled syringe contains 75 mg risankizumab.
Croatian: Jedna napunjena štrcaljka sadrži 75 mg risankizumaba.
English: Table 3: Mean changes from baseline in NAPSI, PPASI, and PSSI ULTIMMA-1
Croatian: Tablica 3: Srednja vrijednost promjene od početnog NAPSI, PPASI i PSSI rezultata ULTIMMA-1
English: • Repeat Steps 2 through 6 with the second syringe
Croatian: • Uzmite drugu štrcaljku i ponovite postupak od 2. do 6. koraka.
English: How Skyrizi works
Croatian: Kako Skyrizi djeluje
English: Plunger rod Finger grip
Croatian: Klip Hvatište za prste Pokrov igle
English: Subjects randomised to risankizumab received 150 mg of treatment at week 0, week 4 and every 12 weeks thereafter.
Croatian: Ispitanici randomizirani za liječenje risankizumabom primili su dozu od 150 mg u 0. tjednu i 4. tjednu, a zatim svakih 12 tjedana.
English: Patients receiving risankizumab should be monitored for signs and symptoms of active TB.
Croatian: Bolesnike koji primaju risankizumab potrebno je nadzirati zbog moguće pojave znakova i simptoma aktivne tuberkuloze.
English: • PASI 90 continued to receive adalimumab
Croatian: • bolesnici s odgovorom PASI 90 nastavili su primati adalimumab
English: Each pack contains 2 pre-filled syringes and 2 alcohol pads.
Croatian: Jedno pakiranje sadrži 2 napunjene štrcaljke i 2 jastučića natopljena alkoholom.
English: No specific studies have been conducted to determine the effect of renal or hepatic impairment on the pharmacokinetics of risankizumab.
Croatian: Nisu provedena posebna ispitivanja kojima bi se odredio učinak oštećenja funkcije bubrega ili jetre na farmakokinetiku risankizumaba.
English: Read section 7 ‘Instructions for use' at the end of this leaflet before injecting Skyrizi yourself.
Croatian: Prije nego što sami injicirate lijek Skyrizi, pročitajte dio 7. „Upute za uporabu“ na kraju ove upute o lijeku.
English: If you forget to use Skyrizi
Croatian: Ako ste zaboravili primijeniti lijek Skyrizi
English: Skyrizi 75 mg injection risankizumab SC
Croatian: Skyrizi 75 mg injekcija risankizumab s.c.
English: Figure 1: Time course of mean percent change from baseline of PASI in ULTIMMA-1 and ULTIMMA-2
Croatian: Slika 1: Vremenski tijek srednje vrijednosti postotne promjene PASI rezultata od početne vrijednosti u ispitivanjima ULTIMMA-1 i ULTIMMA-2
English: Do not use this medicine if the liquid is cloudy or contains flakes or large particles.
Croatian: Nemojte primijeniti ovaj lijek ako je tekućina mutna ili sadrži pahuljice ili velike čestice.
English: • PASI 50 to <PASI 90 were re-randomised to either continue adalimumab or switch to risankizumab
Croatian: • bolesnici s odgovorom između PASI 50 i <PASI 90 bili su ponovno randomizirani za nastavak liječenja adalimumabom ili prelazak na risankizumab
English: Continued on Adalimumab (N=56) n (%)
Croatian: Nastavak liječenja adalimumabom (N=56) n (%)
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.
Croatian: Srednja vrijednost (±standardno odstupanje) sistemskog klirensa (CL) risankizumaba među ispitanicima s psorijazom u ispitivanjima faze 3 iznosila je 0,3 (±0,1) l/dan.
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.
Croatian: Među tim je ispitanicima sPGA rezultat „čisto“ u 104. tjednu ostvarilo 63,1% (70/111) onih koji su ponovnom randomizacijom određeni za nastavak liječenja risankizumabom, u usporedbi s 2,2% (5/225) onih kojima je ponovnom randomizacijom određen prekid liječenja risankizumabom.
English: Week 52 262 (86.2) sPGA of clear (0) Week 16 112 (36.8) Week 52 175 (57.6) PASI 75
Croatian: 16. tjedan 52. tjedan 262 (86,2) sPGA: „čisto“ (0) 16. tjedan 112 (36,8) 52. tjedan 175 (57,6) PASI 75 12. tjedan 264 (86,8) 52. tjedan 279 (91,8) PASI 90
English: Week 16
Croatian: 16. tjedan a
English: If you stop using Skyrizi
Croatian: Ako prestanete primjenjivati lijek Skyrizi
English: Skyrizi 75 mg solution for injection in pre-filled syringe
Croatian: Skyrizi 75 mg otopina za injekciju u napunjenoj štrcaljki
English: Administration of Skyrizi in the upper, outer arm may only be performed by a healthcare professional or caregiver.
Croatian: Skyrizi u vanjski dio nadlaktice smije primijeniti samo zdravstveni radnik ili njegovatelj.
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.
Croatian: Među ispitanicima koji su u 28. tjednu ispitivanja IMMHANCE imali sPGA rezultat „čisto“ ili „gotovo čisto“, odgovor se u 104. tjednu održao u 81,1% (90/111) onih koji su ponovnom randomizacijom određeni za nastavak liječenja risankizumabom, u usporedbi sa 7,1% (16/225) onih kojima je ponovnom randomizacijom određen prekid liječenja risankizumabom.
English: Other side effects Tell your doctor, pharmacist or nurse if you get any of the following side effects
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako primijetite bilo koju od sljedećih nuspojava
English: No specific studies were conducted to assess the effect of hepatic or renal impairment on the pharmacokinetics of Skyrizi.
Croatian: Nisu provedena posebna ispitivanja u kojima bi se ocijenio učinak oštećenja funkcije jetre ili bubrega na farmakokinetiku lijeka Skyrizi.
English: Placebo (N=102) n (%)
Croatian: Placebo (N=102)
English: Needle guard
Croatian: Štitnik za iglu
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
Croatian: Psoriasis Symptom Scale, PSS) podrazumijeva odsustvo simptoma boli, svrbeža, crvenila i žarenja tijekom prethodna 24 sata
English: Improvements were observed in psoriasis involving the scalp, the nails, and the palms and soles at week 16 and week 52 in subjects treated with risankizumab.
Croatian: U ispitanika liječenih risankizumabom opaženo je poboljšanje psorijaze na tjemenu, noktima te dlanovima i tabanima u 16. tjednu i 52. tjednu.
English: Please read all of section 7 before using Skyrizi
Croatian: Prije primjene lijeka Skyrizi pročitajte cijeli dio 7.
English: • The liquid should look clear to slightly yellow and may contain tiny white or clear particles
Croatian: • Tekućina mora biti bezbojna do svjetložuta te može sadržavati sitne bijele ili prozirne čestice.
English: 150 mg (two 75 mg injections) 4 weeks after 1
Croatian: 150 mg (dvije injekcije od 75 mg)
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.
Croatian: Skyrizi je bistra i bezbojna do svjetložuta tekućina u napunjenoj štrcaljki sa štitnikom za iglu.
English: Risankizumab is not expected to undergo metabolism by hepatic enzymes or renal elimination.
Croatian: Ne očekuje se metabolizam risankizumaba djelovanjem jetrenih enzima ni njegova eliminacija kroz bubrege.
English: • Do not inject if the liquid is cloudy or contains flakes or large particles.
Croatian: • Nemojte injicirati lijek ako je tekućina mutna ili ako sadrži pahuljice ili velike čestice.
English: The liquid should look clear to slightly yellow and may contain tiny white or clear particles
Croatian: Tekućina mora biti bezbojna do svjetložuta te može sadržavati sitne bijele ili prozirne čestice.
English: Table 5: Efficacy results 28 weeks after re-randomisation in IMMVENT Switched to Risankizumab (N=53) n (%)
Croatian: Tablica 5: Rezultati za djelotvornost 28 tjedana nakon ponovne randomizacije u ispitivanju IMMVENT
English: It is unknown whether risankizumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se risankizumab u majčino mlijeko.
English: STEP 2
Croatian: 2. KORAK
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava često glavobolja
English: Percent of Subjects
Croatian: Postotak ispitanika
English: STEP 1
Croatian: 1. KORAK
English: • front of left thigh
Croatian: • prednji dio lijevog bedra
English: nd dose
Croatian: 2. doza
English: STEP 5
Croatian: 5. KORAK
English: - The other ingredients are disodium succinate hexahydrate, succinic acid, sorbitol, polysorbate
Croatian: Drugi sastojci su dinatrijev sukcinat heksahidrat, sukcinatna kiselina, sorbitol, polisorbat 20 i voda za injekcije.
English: No clinically meaningful differences in risankizumab exposure were observed in Chinese or Japanese subjects compared to Caucasian subjects in a clinical pharmacokinetic study.
Croatian: U kliničkom farmakokinetičkom ispitivanju nisu opažene klinički značajne razlike u izloženosti risankizumabu između ispitanika iz Kine ili Japana i bijelaca.
English: Follow the steps below each time you use Skyrizi
Croatian: Slijedite korake u nastavku pri svakoj primjeni lijeka Skyrizi
English: Skyrizi should not be used if the solution is cloudy or discoloured, or contains large particles.
Croatian: Skyrizi se ne smije primijeniti ako je otopina mutna, ako je promijenila boju ili ako sadrži velike čestice.
English: STEP 4
Croatian: 4. KORAK
English: You may have slight bleeding from where you injected.
Croatian: Na mjestu injiciranja možda ćete primijetiti blago krvarenje.
English: You should not be given certain types of vaccines while using Skyrizi.
Croatian: Tijekom liječenja lijekom Skyrizi ne smijete primiti određene vrste cjepiva.
English: STEP 6
Croatian: 6. KORAK
English: • <PASI 50 were switched to risankizumab
Croatian: • bolesnici s odgovorom <PASI 50 prešli su na risankizumab
English: Skyrizi 75 mg solution for injection in pre-filled syringe risankizumab
Croatian: Skyrizi 75 mg otopina za injekciju u napunjenoj štrcaljki risankizumab
English: Two pre-filled syringes should be injected for the full 150 mg dose.
Croatian: Za primjenu pune doze od 150 mg potrebno je injicirati sadržaj dviju napunjenih štrcaljki.
English: Each pre-filled syringe contains 75 mg risankizumab in 0.83 ml.
Croatian: Jedna napunjena štrcaljka sadrži 75 mg risankizumaba u 0,83 ml.
English: Check liquid
Croatian: Pregledajte tekućinu
English: STEP 3
Croatian: 3. KORAK