FrancophonIA/ELRC3.0 huggingface dataset:
English: Gender or race
Croatian: Spol ili rasa
English: DLQI 0 or 1
Croatian: DLQI 0 ili 1
English: If you stop treatment, your symptoms may come back.
Croatian: Ako prekinete liječenje, simptomi se mogu vratiti.
English: 67061 Ludwigshafen Germany
Croatian: 67061 Ludwigshafen Njemačka
English: Campoverde di Aprilia (LT) ITALY
Croatian: Campoverde di Aprilia (LT) ITALIJA
English: Talk to your doctor if you are not sure what to do.
Croatian: Obratite se svom liječniku ako niste sigurni što trebate učiniti.
English: • if you have an infection, including active tuberculosis, which your doctor thinks is important.
Croatian: • ako imate infekciju, uključujući aktivnu tuberkulozu, koju Vaš liječnik smatra važnom
English: • Skyrizi should not be warmed in any other way (for example, in a microwave or in hot water)
Croatian: • Skyrizi se ne smije zagrijavati ni na koji drugi način (primjerice, u mikrovalnoj pećnici ili vrućoj vodi).
English: • if the liquid has ever been frozen (even if thawed)
Croatian: • ako je tekućina ikad bila zamrznuta (čak i ako se odmrznula)
English: Weeks After Re-Randomisation
Croatian: Tjedni nakon ponovne randomizacije
English: Elderly (aged 65 years and over)
Croatian: Starije osobe (u dobi od 65 ili više godina)
English: • It is normal to see bubbles in the window
Croatian: • Normalno je da se kroz prozorčić vide mjehurići.
English: Place the following items on a clean, flat surface:
Croatian: Stavite sljedeći pribor na čistu i ravnu površinu:
English: • if you currently have an infection or if you have an infection that keeps coming back.
Croatian: • ako trenutno imate infekciju ili ako imate infekciju koja se neprestano vraća
English: No dose adjustment based on body weight is currently recommended.
Croatian: Trenutno se ne preporučuje prilagođavanje doze na temelju tjelesne težine.
English: Skyrizi is not recommended for children and adolescents under 18 years of age.
Croatian: Skyrizi se ne preporučuje za djecu i adolescente mlađe od 18 godina.
English: This is because it is not known how this medicine will affect the baby.
Croatian: Naime, nije poznato kako će ovaj lijek djelovati na dijete.
English: Choose from these 3 areas to inject:
Croatian: Odaberite jedno od ova 3 područja za injiciranje:
English: Results are presented in Table 4.
Croatian: Rezultati su prikazani u Tablici 4.
English: Hold the body of the syringe in one hand between the thumb and index finger, like you would a pencil.
Croatian: Jednom rukom uhvatite tijelo štrcaljke, između palca i kažiprsta, kao što biste uhvatili olovku.
English: Do not inject into the same place.
Croatian: Ne smije se injicirati na istom mjestu.
English: What Skyrizi is and what it is used for
Croatian: Što je Skyrizi i za što se koristi
English: It reduces the inflammation.
Croatian: Na taj način smanjuje upalu.
English: • Do not inject through clothes
Croatian: • Nemojte injicirati lijek kroz odjeću.
English: • Do not touch the needle with your fingers or let the needle touch anything
Croatian: • Nemojte dodirivati iglu prstima niti dopustiti da igla dotakne bilo što drugo.
English: Maintenance of response
Croatian: Održavanje odgovora
English: Slowly take your thumb off the plunger.
Croatian: Polako podignite palac s klipa.
English: Thereafter, dosing should be resumed at the regular scheduled time.
Croatian: Nakon toga potrebno je nastaviti s primjenom prema uobičajenom rasporedu.
English: RZB = risankizumab UST = ustekinumab PBO = placebo p<0.001 at each time point
Croatian: RZB = risankizumab UST = ustekinumab PBO = placebo p<0,001 u svakoj vremenskoj točki
English: • if the expiry date (EXP) has passed
Croatian: • ako mu je istekao rok valjanosti (EXP)
English: Concomitant immunosuppressive therapy or phototherapy
Croatian: Istodobna imunosupresijska terapija ili fototerapija
English: sPGA of clear or almost clear (0 or 1)
Croatian: sPGA: „čisto“ ili „gotovo čisto“ (0 ili 1)
English: The needle will then be covered by the needle guard.
Croatian: Iglu će tada prekriti štitnik za iglu.
English: All comparisons achieved p<0.001
Croatian: Kod svih je usporedbi postignut p<0,001
English: If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab.
Croatian: Ako je bolesnik primio živo cjepivo (virusno ili bakterijsko), preporučuje se pričekati najmanje 4 tjedna prije početka liječenja risankizumabom.
English: No dose adjustment is required (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu (vidjeti dio 5.2).
English: The rate of serious infections was 1.7 events per 100 subject-years (see section 4.4).
Croatian: Stopa ozbiljnih infekcija bila je 1,7 događaja po 100 ispitanik-godina (vidjeti dio 4.4).
English: • fever, flu-like symptoms, night sweats
Croatian: • vrućica, simptomi nalik gripi, noćno znojenje
English: The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13% of patients.
Croatian: Najčešće prijavljene nuspojave bile su infekcije gornjih dišnih putova, koje su se javile u 13% bolesnika.
English: This medicine is given as 2 injections under your skin (called ‘subcutaneous injections').
Croatian: Ovaj lijek se primjenjuje u obliku 2 injekcije pod kožu („supkutane injekcije“).
English: The safety and efficacy of Skyrizi in children and adolescents aged 6 to 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Skyrizi u djece i adolescenata u dobi od 6 do 18 godina nisu još ustanovljene.
English: Start with one syringe for the first injection.
Croatian: Uzmite jednu štrcaljku za prvu injekciju.
English: Uncommon: may affect up to 1 in 100 people • small raised red bumps on the skin
Croatian: Manje česte: mogu se javiti u do 1 na 100 osoba • male uzdignute crvene kvržice na koži
English: Clinically important active infections (e.g. active tuberculosis, see section 4.4).
Croatian: Klinički značajne aktivne infekcije (npr. aktivna tuberkuloza, vidjeti dio 4.4).
English: If you forget to use Skyrizi, inject a dose as soon as you remember.
Croatian: Ako ste zaboravili primijeniti Skyrizi, injicirajte dozu čim se sjetite.
English: As a precautionary measure, it is preferable to avoid the use of risankizumab during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu risankizumaba tijekom trudnoće.
English: Slowly push the plunger all the way in until all of the liquid is injected.
Croatian: Polako pritisnite klip do kraja, sve dok ne injicirate svu tekućinu.
English: • The needle guard will not activate unless all the liquid is injected
Croatian: • Štitnik za iglu neće se aktivirati ako se ne injicira sva tekućina.
English: • injection site reactions (such as redness or pain)
Croatian: • reakcije na mjestu injiciranja (kao što su crvenilo ili bol)
English: • Special disposal container (not included in the carton)
Croatian: • poseban spremnik za odlaganje (nije uključen u pakiranje)
English: • if you have tuberculosis (TB).
Croatian: • ako imate tuberkulozu
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC18
Croatian: Farmakoterapijska skupina: Imunosupresivi, inhibitori interleukina, ATK oznaka: L04AC18
English: You and your doctor, pharmacist or nurse will decide if you should inject this medicine yourself.
Croatian: Vi i Vaš liječnik, ljekarnik ili medicinska sestra odlučit ćete trebate li sami injicirati ovaj lijek.
English: Human IgGs are known to be excreted in breast milk during the first few days after birth, which decreases to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period.
Croatian: Poznato je da se tijekom prvih nekoliko dana nakon poroda humana IgG protutijela izlučuju u majčino mlijeko i da njihove koncentracije ubrzo nakon toga padaju na nisku razinu; posljedično, ne može se isključiti rizik za dojenče tijekom tog kratkog razdoblja.
English: The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.
Croatian: Otkrivanje stvaranja protutijela uvelike ovisi o osjetljivosti i specifičnosti testa.
English: For more information and support on Skyrizi go to www.skyrizi.eu or scan this code.
Croatian: Za više informacija o lijeku Skyrizi i podršku posjetite stranicu www.skyrizi.eu ili skenirajte ovaj kôd.
English: This medicine works by stopping a protein in the body called ‘IL-23', which causes inflammation.
Croatian: Ovaj lijek djeluje tako da u tijelu zaustavlja djelovanje proteina pod nazivom „IL-23“, koji uzrokuje upalu.
English: • if you are allergic to risankizumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na risankizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: • Mark the dates on your calendar so you know when to inject Skyrizi
Croatian: • Označite datume na kalendaru kako biste znali kada trebate injicirati Skyrizi.
English: • if you are using, have recently used or might use any other medicines.
Croatian: • ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove
English: Results 28 weeks after re-randomisation are presented in Table 5 and Figure 2.
Croatian: Rezultati 28 tjedana nakon ponovne randomizacije prikazani su u Tablici 5 i na Slici 2.
English: • fungal skin infection
Croatian: • gljivična infekcija kože
English: Very common: may affect more than 1 in 10 people • upper respiratory infections with symptoms such as sore throat and stuffy nose
Croatian: Vrlo česte: mogu se javiti u više od 1 na 10 osoba • infekcije gornjih dišnih putova praćene simptomima poput grlobolje i začepljenog nosa
English: Check the liquid in the syringe.
Croatian: Pregledajte tekućinu u štrcaljki.
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.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primijenite ovaj lijek.
English: For most subjects, antibodies to risankizumab including neutralising antibodies were not associated with changes in clinical response or safety.
Croatian: U većine ispitanika protutijela na risankizumab, uključujući neutralizirajuća protutijela, nisu bila povezana s promjenama u kliničkom odgovoru ili sigurnosti.
English: Your doctor will decide if you can keep using Skyrizi.
Croatian: Vaš će liječnik odlučiti možete li nastaviti primjenjivati lijek Skyrizi.
English: The safety profile of risankizumab with up to 77 weeks of exposure was consistent with the profile observed up to 16 weeks.
Croatian: Sigurnosni profil risankizumaba tijekom najviše 77 tjedana izloženosti bio je u skladu s profilom opaženim do najviše 16. tjedna.
English: IL-23 is a cytokine that is involved in inflammatory and immune responses.
Croatian: IL-23 je citokin koji sudjeluje u upalnim i imunosnim odgovorima.
English: The safety and efficacy of risankizumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Croatian: Nisu se procjenjivale sigurnost i djelotvornost risankizumaba u kombinaciji s imunosupresivima, uključujući biološke lijekove, ili fototerapijom.
English: Talk to your doctor or get medical help immediately if you have symptoms of a serious infection such as:
Croatian: Odmah se obratite svom liječniku ili potražite liječničku pomoć ako imate simptome ozbiljne infekcije kao što su:
English: The same information is also available at the following URL: www.skyrizi.eu
Croatian: Iste informacije možete pronaći i na sljedećoj mrežnoj stranici: www.skyrizi.eu
English: 2 Injections Required
Croatian: Potrebne su 2 injekcije
English: If you have used more Skyrizi than you should or the dose has been given sooner than prescribed, talk to your doctor.
Croatian: Ako ste primijenili više lijeka Skyrizi nego što ste trebali ili ste dozu primijenili prije nego što je propisano, obratite se svom liječniku.
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.
Croatian: Da bi injekcija bila ugodnija: Izvadite kutiju iz hladnjaka i ostavite je na sobnoj temperaturi, podalje od izravne sunčeve svjetlosti, tijekom 15 do 30 minuta prije injiciranja.
English: Table 1: List of adverse reactions in clinical studies
Croatian: Tablica 1: Popis nuspojava iz kliničkih ispitivanja
English: • Hold the syringe in one hand
Croatian: • Uhvatite štrcaljku jednom rukom.
English: Following subcutaneous dosing of risankizumab, peak plasma concentrations were achieved between 3-14 days after dosing with an estimated absolute bioavailability of 89%.
Croatian: Nakon supkutane primjene risankizumaba vršne plazmatske koncentracije postignute su 3-14 dana nakon primjene, uz procijenjenu apsolutnu bioraspoloživost od 89%.
English: • Do not throw away used syringes in the household waste
Croatian: • Nemojte baciti upotrijebljene štrcaljke u kućni otpad.
English: Throw away used syringes in a special disposal container.
Croatian: Bacite upotrijebljene štrcaljke u poseban spremnik za odlaganje.
English: Return this medicine to the pharmacy
Croatian: Vratite lijek u ljekarnu:
English: Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Croatian: Nekim bolesnicima koji prvotno ostvare djelomičan odgovor stanje se naknadno može poboljšati s nastavkom liječenja nakon 16 tjedana.
English: A total of 9.8% of study subjects had a history of diagnosed psoriatic arthritis.
Croatian: Ukupno je 9,8% ispitanika imalo dijagnosticirani psorijatični artritis u anamnezi.
English: Women of childbearing potential should use an effective method of contraception during treatment and for at least 21 weeks after treatment.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu metodu kontracepcije tijekom liječenja i još najmanje 21 tjedan nakon liječenja.
English: If a dose is missed, the dose should be administered as soon as possible.
Croatian: Ako se doza propusti, potrebno ju je primijeniti što je prije moguće.
English: If you are a woman who can become pregnant, you should use contraception while using this medicine and for at least 21 weeks after your last dose of Skyrizi.
Croatian: Ako ste žena koja može zatrudnjeti, morate koristiti kontracepciju dok primjenjujete ovaj lijek i još najmanje 21 tjedan nakon posljednje doze lijeka Skyrizi.
English: Removing the needle cover:
Croatian: Skidanje pokrova igle:
English: A decision should be made whether to discontinue/abstain from risankizumab therapy, taking into account the benefit of breast-feeding to the child and the benefit of risankizumab therapy to the woman.
Croatian: Potrebno je odlučiti da li prekinuti liječenje/suzdržati se od liječenja risankizumabom uzimajući u obzir korist dojenja za dijete i korist liječenja risankizumabom za ženu.
English: Gently pinch the area of cleaned skin with your other hand and hold it firmly.
Croatian: Drugom rukom nježno uhvatite nabor očišćene kože i čvrsto ga držite.
English: The injection site reactions were all mild to moderate in severity, none were serious, and none led to discontinuation of risankizumab.
Croatian: Sve su reakcije na mjestu injiciranja bile blage do umjerene težine, nijedna nije bila ozbiljna i nijedna nije dovela do prekida liječenja risankizumabom.
English: • if the syringe paper tray cover is broken or missing
Croatian: • ako je papirnati pokrov podloška štrcaljke oštećen ili nedostaje
English: • Inject the second syringe straight after the first injection but at least 3 cm away from the first injection
Croatian: • Sadržaj druge štrcaljke injicirajte odmah nakon prve injekcije, ali najmanje 3 cm od mjesta primjene prve injekcije.
English: • Speak to your doctor, pharmacist or nurse if you think you have not given a full dose
Croatian: • Obratite se svom liječniku, ljekarniku ili medicinskoj sestri ako mislite da niste primijenili punu dozu.
English: As with all therapeutic proteins, there is the potential for immunogenicity with risankizumab.
Croatian: Kao i svi terapijski proteini, risankizumab može imati imunogeno djelovanje.
English: Do not stop using Skyrizi without talking to your doctor first.
Croatian: Nemojte prestati primjenjivati lijek Skyrizi bez prethodnog razgovora sa svojim liječnikom.
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).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja risankizumaba u jednoj ili više podskupina pedijatrijske populacije za liječenje plak psorijaze (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: • if the syringe has been dropped or damaged
Croatian: • ako je štrcaljka pala ili ako je oštećena
English: sPGA of clear or almost clear PASI 75
Croatian: sPGA: „čisto“ ili „gotovo čisto“ PASI 75
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%).
Croatian: Incidencija reakcija na mjestu injiciranja brojčano je veća u skupinama koje su bile pozitivne na protutijela na lijek u odnosu na skupine koje su bile negativne na protutijela na lijek tijekom kratkotrajnog (16 tjedana: 2,7% naspram 1,3%) i dugotrajnijeg liječenja (>52 tjedna: 5,0% naspram 3,3%).
English: Press a cotton ball or gauze pad where you have injected and hold for 10 seconds.
Croatian: Pritisnite komad pamučne vate ili gaze na mjesto injiciranja i držite ga tako 10 sekundi.
English: There is limited safety information in subjects aged ≥65 years.
Croatian: Postoje ograničene sigurnosne informacije u ispitanika u dobi od ≥65 godina.
English: • You may see a drop of liquid at the end of the needle.
Croatian: • Možda ćete na vrhu igle vidjeti kapljicu tekućine.
English: Patients treated with risankizumab should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur.
Croatian: Bolesnike liječene risankizumabom potrebno je uputiti da potraže savjet liječnika ako se pojave znakovi ili simptomi klinički važne kronične ili akutne infekcije.
English: • your belly (abdomen) at least 5 cm from your belly button (navel)
Croatian: • trbuh (abdomen), najmanje 5 cm od pupka
English: If you use more Skyrizi than you should
Croatian: Ako primijenite više lijeka Skyrizi nego što ste trebali
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.
Croatian: Bolesnike je potrebno uputiti da za punu dozu od 150 mg injiciraju sadržaj 2 napunjene štrcaljke te da prije primjene pročitaju „Upute za uporabu“ navedene u uputi o lijeku.
English: Risankizumab clearance and volume of distribution increase as body weight increases which may result in reduced efficacy in subjects with high body weight (>130 kg).
Croatian: Klirens i volumen distribucije risankizumaba povećavaju se s porastom tjelesne težine što može dovesti do smanjene djelotvornosti u ispitanika s velikom tjelesnom težinom (>130 kg).
English: Prior to use, a visual inspection of each pre-filled syringe is recommended.
Croatian: Prije primjene preporučuje se vizualno pregledati svaku napunjenu štrcaljku.
English: Do not use this medicine after the expiry date which is stated on the syringe label and outer carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici štrcaljke i kutiji iza oznake „EXP“.
English: Starting at week 16, subjects who were receiving adalimumab continued or switched treatment based on response:
Croatian: Počevši od 16. tjedna, ispitanici koji su primali adalimumab nastavili su primati isto liječenje ili su prešli na drugi lijek, ovisno o odgovoru:
English: Pull the needle out of the skin while keeping the syringe at the same angle.
Croatian: Izvucite iglu iz kože držeći štrcaljku cijelo vrijeme pod istim kutom.
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.
Croatian: Od 2234 ispitanika s plak psorijazom izložena risankizumabu, njih 243 bilo je u dobi od 65 ili više godina, a 24 ispitanika imala su 75 ili više godina.
English: Figure 2: Time course of PASI 90 after re-randomisation in IMMVENT
Croatian: Slika 2: Vremenski tijek PASI 90 rezultata nakon ponovne randomizacije u ispitivanju IMMVENT
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
Croatian: Uključuje: infekciju dišnih putova (virusnu, bakterijsku ili nespecificiranu), sinusitis (uključujući akutni), rinitis, nazofaringitis, faringitis (uključujući virusni), tonzilitis Uključuje: infekcije tinea pedis, tinea cruris, tinea corporis, tinea versicolor, tinea manuum, onihomikozu Uključuje: glavobolju, tenzijsku glavobolju, sinusnu glavobolju Uključuje: umor, asteniju Uključuje: nastanak modrica, eritem, hematom, krvarenje, nadraženost, bol, pruritus, reakciju i oticanje na mjestu injiciranja
English: For each dose, the injections should be administered at different anatomic locations (such as thighs or abdomen), and not into areas where the skin is tender, bruised, erythematous, indurated or affected by psoriasis.
Croatian: Kod primjene svake doze, injekcije se moraju primijeniti u različita anatomska područja (kao što su bedra ili abdomen), ali se ne smiju primijeniti u područja na kojima je koža osjetljiva na dodir, prekrivena modricama, eritematozna, otvrdnula ili zahvaćena psorijazom.
English: Skyrizi is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Croatian: Skyrizi je namijenjen za primjenu pod vodstvom i nadzorom liječnika koji ima iskustva s dijagnosticiranjem i liječenjem psorijaze.
English: Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment (see section 5.2).
Croatian: Bolesnici liječeni risankizumabom ne smiju primiti živa cjepiva tijekom liječenja ni najmanje 21 tjedan nakon liječenja (vidjeti dio 5.2).
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.
Croatian: Prema podacima iz svih ispitivanja, 30,9% ispitanika prethodno nije primalo nikakvu sistemsku terapiju (uključujući nebiološku i biološku), 38,1% njih prethodno je primalo fototerapiju ili fotokemoterapiju, 48,3% prethodno je bilo liječeno nebiološkom sistemskom terapijom, 42,1% prethodno je primalo biološku terapiju, a 23,7% primilo je najmanje jedan inhibitor TNFα za liječenje psorijaze.
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).
Croatian: Djelotvornost i sigurnost risankizumaba ocjenjivale su se u 2109 ispitanika s umjerenom do teškom plak psorijazom u četiri multicentrična, randomizirana, dvostruko slijepa ispitivanja (ULTIMMA-1, ULTIMMA-2, IMMHANCE i IMMVENT).
English: • Throw away the needle cover
Croatian: • Bacite pokrov igle.