FrancophonIA/ELRC3.0 huggingface dataset:
English: • When the plunger is pushed as far as it will go, continue to keep the pressure on the plunger head, take out the needle and let go of the skin (see Figure 6)
Slovenian: • Ko ste bat potisnili do konca, še naprej pritiskajte na glavo bata, izvlecite iglo iz kože ter spustite kožno gubo (glejte Sliko 6).
English: The medicinal product should not be used if the solution is discoloured or cloudy, or if foreign particulate matter is present.
Slovenian: Zdravila ne smete uporabljati, če je raztopina obarvana ali motna ali če so v njej vidni tuji delci.
English: STELARA has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo STELARA nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: 44 week subcutaneous randomized withdrawal maintenance study (referred to as UNIFI-M) representing at least 52 weeks of therapy.
Slovenian: Tej študiji je sledila 44-tedenska randomizirana študija subkutanega vzdrževalnega zdravljenja in odtegnitve zdravljenja (z nazivom UNIFI-M), kar skupaj predstavlja najmanj 52 tednov zdravljenja.
English: Thus, caution should be exercised when considering the use of STELARA in these patients.
Slovenian: Če razmišljate o uporabi zdravila STELARA pri teh bolnikih, je torej potrebna previdnost.
English: • Push the plunger with your thumb as far as it will go to inject all of the liquid.
Slovenian: • S palcem potisnite bat do konca in injicirajte vso tekočino.
English: In patients with Crohn's disease and ulcerative colitis, treatment with ustekinumab resulted in a decrease in inflammatory markers including C-Reactive Protein (CRP) and fecal calprotectin during the induction phase, which were then maintained throughout the maintenance phase.
Slovenian: Zdravljenje z ustekinumabom je pri bolnikih s Crohnovo boleznijo in ulceroznim kolitisom med indukcijsko fazo zmanjšalo prisotnost vnetnih markerjev, vključno s C-reaktivnim proteinom (CRP) in fekalnim kalprotektinom, kar se je ohranilo skozi celotno vzdrževalno fazo.
English: The formation of anti-ustekinumab antibodies is associated with increased clearance of ustekinumab in patients with Crohn's disease or ulcerative colitis.
Slovenian: Nastanek protiteles proti ustekinumabu povezujejo s povečanim očistkom ustekinumaba pri bolnikih s Crohnovo boleznijo ali ulceroznim kolitisom.
English: Approximately 48% of the patients had failed 1 prior anti-TNF therapy and 52% had failed 2 or 3 prior anti-TNFα therapies.
Slovenian: Pri približno 48% bolnikov je bilo neuspešno 1 predhodno zdravljenje z zaviralci TNFα in pri 52% 2 ali 3 predhodna zdravljenja z zaviralci TNFα.
English: In Study 2, the majority of patients (58%, n = 180) had been previously treated with one or more anti-TNFα agent(s), of whom over 70% had discontinued their anti-TNFα treatment for lack of efficacy or intolerance at any time.
Slovenian: V 2. študiji je bila večina (58%, n = 180) bolnikov že zdravljenih z enim ali več zaviralci TNFα, 70% teh bolnikov je zdravljenje zaradi pomankanja učinkovitosti ali intolerance prekinilo.
English: In the population pharmacokinetic analyses of the phase 3 studies, the effect of the most frequently used concomitant medicinal products in patients with psoriasis (including paracetamol, ibuprofen, acetylsalicylic acid, metformin, atorvastatin, levothyroxine) on pharmacokinetics of ustekinumab was explored.
Slovenian: V analizi populacijske farmakokinetike na podlagi študij faze 3 so raziskovali vpliv zdravil, ki jih najpogosteje sočasno uporabljamo pri bolnikih s psoriazo (vključno s paracetamolom, ibuprofenom, acetilsalicilno kislino, metforminom, atorvastatinom in levotiroksinom), na farmakokinetiko ustekinumaba.
English: In patients with Crohn's disease and ulcerative colitis, variability in ustekinumab clearance was affected by body weight, serum albumin level, sex, and antibody to ustekinumab status while body weight was the main covariate affecting the volume of distribution.
Slovenian: Pri bolnikih s Crohnovo boleznijo in ulceroznim kolitisom so na variabilnost očistka ustekinumaba vplivali telesna masa, koncentracija serumskih albuminov, spol in status protiteles proti ustekinumabu, telesna masa pa je bila glavna sospremenljivka, ki je vplivala na porazdelitveni volumen.
English: STELARA 130 mg is for intravenous use only.
Slovenian: Zdravilo STELARA 130 mg je namenjeno le za intravensko uporabo.
English: Any diluted infusion solution or unused product remaining in the vial and the syringe should be thrown away in accordance with local requirements.
Slovenian: Razredčeno raztopino za infundiranje ali neuporabljeno zdravilo, ki ostane v viali in brizgi, je treba zavreči v skladu z lokalnimi predpisi.
English: Health-related quality of life was assessed by Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36 and EuroQoL-5D (EQ-5D) questionnaires.
Slovenian: Z zdravjem povezano kakovost življenja so ocenjevali z vprašalniki za oceno vnetnih bolezni črevesja (IBDQ - Inflammatory Bowel Disease Questionnaire), SF-36 (Short Form-36) in EuroQoL-5D (EQ-5D).
English: Table 2 Injection volumes of STELARA for paediatric psoriasis patients < 60 kg Body weight at time of dosing (kg)
Slovenian: Preglednica 2 Volumen raztopine zdravila STELARA pri pediatričnih bolnikih s psoriazo in teleso maso < 60 kg Telesna masa ob odmerjanju (kg)
English: STELARA concentrate for solution for infusion should only be used for the intravenous induction dose.
Slovenian: Zdravilo STELARA koncentrat za raztopino za infundiranje se uporablja samo kot uvajalni intravenski odmerek.
English: STELARA should not be administered concomitantly in the same intravenous line with other medicinal products.
Slovenian: Zdravila STELARA ne smete infundirati istočasno z drugimi zdravili po isti intravenski liniji.
English: The overall safety profile was similar for patients with psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.
Slovenian: Celokupni varnostni profil je bil pri bolnikih s psoriazo, psoriatičnim artritisom, Crohnovo boleznijo in ulceroznim kolitisom podoben.
English: • The first dose of Stelara for treatment of Crohn's disease or ulcerative colitis is given by a doctor as a drip in the vein of an arm (intravenous infusion).
Slovenian: • Prvi odmerek zdravila Stelara za zdravljenje Crohnove bolezni ali ulceroznega kolitisa vam bo dal zdravnik v obliki kapljične infuzije v eno od ven na roki (intravenska infuzija).
English: Ustekinumab has been shown to improve signs and symptoms, physical function and health-related quality of life, and reduce the rate of progression of peripheral joint damage in adult patients with active PsA.
Slovenian: Dokazano je, da ustekinumab izboljšuje znake in simptome, telesno zmogljivost in z zdravjem povezano kakovost življenja ter upočasni napredovanje perifernih sprememb sklepov pri odraslih bolnikih z aktivnim PsA.
English: • fever, flu-like symptoms, night sweats
Slovenian: • zvišano telesno temperaturo, gripi podobne simptome, nočno potenje
English: Serum ustekinumab concentrations in paediatric psoriasis patients 12-17 years of age (CADMUS) treated with half of the recommended weight-based dose were generally lower than those in adults.
Slovenian: Serumske koncentracije ustekinumaba pri pediatričnih bolnikih s psoriazo, starih 12-17 let (CADMUS), zdravljenih s polovico priporočenega odmerka glede na telesno maso pa so bile v splošnem nižje kot pri odraslih.
English: Approximately one third (Psoriasis Study 1) and one quarter (Psoriasis Study 2) of subjects had Psoriatic Arthritis (PsA).
Slovenian: Približno ena tretjina preiskovancev v 1. študiji psoriaze in ena četrtina preiskovancev v 2. študiji psoriaze je imela psoriatični artritis (Psoriatic Arthritis-PsA).
English: In a subgroup of patients with draining fistulas at baseline (8.8%; n = 26), 12/15 (80%) of ustekinumab-treated patients achieved a fistula response over 44 weeks (defined as ≥ 50% reduction from baseline of the induction study in the number of draining fistulas) compared to 5/11 (45.5%) exposed to placebo.
Slovenian: V podskupini bolnikov s fistulami z izcedkom ob izhodišču (8,8%; n = 26), je 12/15 (80%) bolnikov, zdravljenih z ustekinumabom, doseglo klinični odziv v obdobju 44 tednov (opredeljen kot ≥ 50% zmanjšanje od izhodišča študije indukcijskega zdravljenja v številu fistul z izcedkom) v primerjavi s 5/11 (45,5%) bolnikov, izpostavljenih placebu.
English: There were no indications of an interaction with these concomitantly administered medicinal products.
Slovenian: Znakov medsebojnih delovanj z omenjenimi zdravili pri njihovi sočasni uporabi niso našli.
English: The infusion should be completed within 8 hours of the dilution in the infusion bag.
Slovenian: Infundiranje je treba zaključiti v 8 urah po redčenju v infuzijski vrečki.
English: Of 131 patients who responded to ustekinumab induction, and were randomized to the placebo group at the start of the maintenance study, 51 subsequently lost response and received 90 mg ustekinumab subcutaneously every 8 weeks.
Slovenian: Med 131 bolniki, ki so se odzvali na indukcijo z ustekinumabom in so bili na začetki vzdrževalne študije randomizirani v skupino, ki je prejemala placebo, jih je 51 izgubilo odziv na zdravljenje in so prešli na subkutano odmerjanje 90 mg ustekinumaba na 8 tednov.
English: In developmental and reproductive toxicity studies in cynomolgus monkeys, neither adverse effects on male fertility indices nor birth defects or developmental toxicity were observed.
Slovenian: V študijah toksičnosti za razvoj in sposobnost razmnoževanja pri opicah Cynomolgus niso opazili niti neželenih učinkov na pokazatelje plodnosti pri samcih, niti prirojenih anomalij ali toksičnosti za razvoj pri mladičih.
English: Paediatric patients 6 years and older with plaque psoriasis The safety of ustekinumab has been studied in two phase 3 studies of paediatric patients with moderate to severe plaque psoriasis.
Slovenian: Pediatrični bolniki s psoriazo s plaki, stari 6 let in več Varnost ustekinumaba so preučevali v dveh študijah faze 3 pri pediatričnih bolnikih z zmerno do hudo psoriazo s plaki.
English: In Psoriasis Study 2, the Hospital Anxiety and Depression Scale (HADS) and Work Limitations Questionnaire (WLQ) were also significantly improved in each ustekinumab treatment group compared with placebo.
Slovenian: V 2. študiji psoriaze sta bila tudi rezultata Bolnišnične lestvice tesnobe in depresije (Hospital Anxiety and Depression Scale - HADS) in vprašalnika o delovnih omejitvah (WLQ - Work Limitations Questionnaire) v obeh terapevtskih skupinah z ustekinumabom bistveno izboljšana v primerjavi s placebom.
English: In a population pharmacokinetic analysis, the apparent clearance (CL/F) and apparent volume of distribution (V/F) were 0.465 l/day and 15.7 l, respectively, in patients with psoriasis.
Slovenian: V analizi populacijske farmakokinetike pri bolnikih s psoriazo je znašal navidezni očistek zdravila (CL/F) 0,465 l/dan, navidezni porazdelitveni volumen (V/F) pa 15,7 l. Spol ni vplival na CL/F ustekinumaba.
English: Do not use Stelara:
Slovenian: Ne uporabljajte zdravila Stelara
English: • the pre-filled syringe is not damaged
Slovenian: • da napolnjena injekcijska brizga ni poškodovana,
English: Single doses up to 6 mg/kg have been administered intravenously in clinical studies without dose-limiting toxicity.
Slovenian: V kliničnih študijah so bolnikom dajali enkratne intravenske odmerke do 6 mg/kg, brez toksičnih učinkov, ki bi omejevali odmerek zdravila.
English: • If someone will assist in giving you the injection, then he or she may also choose the upper arms as an injection site.
Slovenian: • Če vam bo kdo drug dal injekcijo, lahko za mesto injiciranja izbere tudi nadlaket.
English: Ustekinumab cannot bind to IL-12 or IL-23 that is already bound to IL-12R1 cell surface receptors.
Slovenian: Ustekinumab se ne more vezati na interlevkina IL-12 in IL-23, ki sta že vezana na receptorje IL-12R1 na celični površini.
English: Remove the needle cover (see Figure 3):
Slovenian: Odstranite pokrovček z igle (glejte Sliko 3)
English: In clinical studies, patients with latent tuberculosis who were concurrently treated with isoniazid did not develop tuberculosis.
Slovenian: Pri bolnikih z latentno tuberkulozo, ki so bili sočasno zdravljeni z izoniazidom, se v kliničnih študijah ni pojavila tuberkuloza.
English: All patients were followed for up to 52 weeks following first administration of study treatment.
Slovenian: Vse bolnike so spremljali do 52 tednov po prvem prejemu proučevanega zdravila.
English: Patients who were re-randomised to placebo at week 40 reinitiated ustekinumab at their original dosing regimen when they experienced at least a 50% loss of their PASI improvement obtained at week 40.
Slovenian: Bolnikom, ki so jih kasneje naključno uvrstili v skupino za prejemanje placeba v 40. tednu, so potem ponovno uvedli ustekinumab v prvotni shemi odmerjanja, če so pri njih opazili najmanj 50% upad izboljšanja indeksa PASI, doseženega v 40. tednu.
English: The most serious adverse reaction that has been reported for STELARA is serious hypersensitivity reactions including anaphylaxis (see section 4.4).
Slovenian: Najresnejši neželeni učinek, o katerem so poročali pri uporabi zdravila STELARA, je huda preobčutljivostna reakcija, vključno z anafilakso (glejte poglavje 4.4).
English: Table 7 Summary of primary and secondary endpoints at week 12 and week 52 Paediatric psoriasis study (CADMUS) (Age 12-17) Week 12
Slovenian: Preglednica 7: Povzetek primarnih in sekundarnih ciljev v 12. in 52. tednu Študija pediatrične psoriaze (CADMUS) (12-17 let) 12. teden
English: In a population pharmacokinetic analysis using data from patients with psoriasis, body weight was found to be the most significant covariate affecting the clearance of ustekinumab.
Slovenian: V analizi populacijske farmakokinetike, kjer so uporabili podatke bolnikov s psoriazo, so ugotovili, da je med drugimi spremenljivkami, ki vplivajo na očistek ustekinumaba, najpomembnejša telesna masa.
English: In rare cases, allergic lung reactions and lung inflammation have been reported in patients who receive ustekinumab.
Slovenian: V redkih primerih so pri bolnikih, ki so prejemali ustekinumab, poročali o alergijskih reakcijah pljuč in vnetju pljuč.
English: Crohn's disease or Ulcerative Colitis
Slovenian: Crohnova bolezen ali ulcerozni kolitis
English: Women of childbearing potential should use effective methods of contraception during treatment and for at least 15 weeks after treatment.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem in do 15 tednov po njem uporabljati učinkovito in varno kontracepcijsko metodo.
English: Patients in UNITI-2 had failed at least one conventional therapy, including corticosteroids or immunomodulators, and were either anti-TNF-α naïve (68.6%) or had previously received but not failed anti-TNFα therapy (31.4%).
Slovenian: Pri bolnikih v študiji UNITI-2 je bilo neuspešno najmanj eno konvencionalno zdravljenje (vključno s kortikosteroidi ali imunomodulatorji) in se še niso zdravili z zaviralci TNFα (68,6%) ali pa so se zdravili z zaviralci TNFα in se na zdravljenje niso odzvali (31,4%).
English: Approximately 50% of the patients had failed at least 1 prior anti-TNF therapy (of which 48% were primary non-responders) and 17% had failed at least 1 anti-TNFα therapy and vedolizumab.
Slovenian: Pri približno 50% bolnikov je bilo neuspešno najmanj eno predhodno zdravljenje z zaviralcem TNF (med njimi je bilo 48% bolnikov primarno neodzivnih na zdravljenje), pri 17% pa je bilo neuspešno zdravljenje z najmanj enim zaviralcem TNFα in vedolizumabom.
English: No studies have been conducted that include patients with a history of malignancy or that continue treatment in patients who develop malignancy while receiving STELARA.
Slovenian: Študij še niso izvedli pri bolnikih, ki so imeli v pretekli anamnezi malignom, ter pri tistih, ki so zdravljenje z zdravilom STELARA nadaljevali tudi po pojavu malignoma.
English: No new safety concerns were identified in this study extension with up to 2 years of treatment in patients with Crohn's Disease.
Slovenian: V tej podaljšani študiji s trajanjem zdravljenja do 2 leti pri bolnikih s Crohnovo boleznijo niso ugotovili nobenih novih tveganj glede varnosti.
English: • Infections of the nose or throat and common cold are common (may affect up to 1 in
Slovenian: • Pogoste so okužbe nosu ali žrela in prehlad (pojavijo se lahko pri več kot 1 od
English: Driving and using machines Stelara has no or negligible influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Stelara nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: STELARA, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).
Slovenian: Zdravilo STELARA je kot samostojno zdravilo ali v kombinaciji z MTX indicirano za zdravljenje aktivnega psoriatičnega artritisa pri odraslih bolnikih, če je bil odziv na predhodno zdravljenje z nebiološkimi protirevmatičnimi zdravili (DMARD- Disease-Modifying Antirheumatic Drugs) nezadosten (glejte poglavje 5.1).
English: The most common adverse reactions (> 5%) in controlled periods of the adult psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies with ustekinumab were nasopharyngitis and headache.
Slovenian: Najpogostejša neželena učinka (> 5%) v nadzorovanih obdobjih kliničnih študij psoriaze, psoriatičnega artritisa, Crohnove bolezni in ulceroznega kolitisa z ustekinumabom pri odraslih sta bila nazofaringitis in glavobol.
English: The absolute bioavailability of ustekinumab following a single subcutaneous administration was estimated to be 57.2% in patients with psoriasis.
Slovenian: Po enkratni subkutani injekciji je bila absolutna biološka uporabnost ustekinumaba pri bolnikih s psoriazo ocenjena na 57,2%.
English: • After the starting dose, you will have the next dose 4 weeks later, and then every 12 weeks.
Slovenian: • Po začetnem odmerku boste po 4 tednih prejeli naslednji odmerek, nadaljne odmerke pa boste prejemali na vsakih 12 tednov.
English: In clinical studies, serious bacterial, fungal, and viral infections have been observed in patients receiving STELARA (see section 4.8).
Slovenian: V kliničnih študijah so pri bolnikih, ki so prejemali zdravilo STELARA, opazili resne bakterijske, glivične in virusne okužbe (glejte poglavje 4.8).
English: Improvements in PGA, PASI, and CDLQI were maintained through week 52 (Table 8).
Slovenian: Izboljšanje v PGA, PASI in CDLQI se je ohranilo do 52. tedna (Preglednica 8).
English: In the placebo-controlled studies of patients with psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis, the rates of infection or serious infection were similar between ustekinumab-treated patients and those treated with placebo.
Slovenian: V s placebom nadzorovanih študijah pri bolnikih s psoriazo, psoriatičnim artritisom, Crohnovo boleznijo in ulceroznim kolitisom so bile pogostnosti okužb in resnih okužb pri bolnikih, zdravljenih z ustekinumabom, podobne kot pri tistih, ki so prejemali placebo.
English: • During treatment, the first dose of approximately 6 mg/kg Stelara will be given by your doctor through a drip in a vein in your arm (intravenous infusion).
Slovenian: • Med zdravljenjem vam bo dal prvi odmerek zdravila Stelara, približno 6 mg/kg, vaš zdravnik v obliki kapljične infuzije v eno od ven na roki (intravenska infuzija).
English: Latex sensitivity
Slovenian: Preobčutljivost za lateks
English: Secondary endpoints included PASI 75, PASI 90, and change from baseline in Children's Dermatology Life Quality Index (CDLQI) at week 12.
Slovenian: Sekundarni cilji so vključevali PASI 75, PASI 90 in spremembo od izhodiščne vrednosti dermatološkega indeksa kakovosti življenja pri otrocih (CDLQI - Children's Dermatology Life Quality Index) v 12. tednu.
English: • Hold the syringe with the needle pointing up to see if it has any air bubbles inside
Slovenian: • Brizgo držite tako, da bo igla gledala navzgor, in preverite, ali je v brizgi kakšen mehurček.
English: 53% of these patients were either non-responsive, intolerant, or had a contraindication to other systemic therapy.
Slovenian: 53% teh bolnikov se bodisi ni odzvalo na drugo sistemsko zdravljenje, ga niso prenašali ali pa so imeli kontraindikacije zanj.
English: • Push the needle through the rubber stopper
Slovenian: • Iglo potisnite skozi gumijasti zamašek.
English: The median steady-state trough concentration ranged from 0.21 μg/mL to 0.26 μg/mL (45 mg) and from 0.47 μg/mL to 0.49 μg/mL (90 mg).
Slovenian: Mediana vrednost najmanjše koncentracije v stanju dinamičnega ravnovesja se je gibala od 0,21 μg/ml do 0,26 μg/ml (45 mg) in od 0,47 μg/ml do 0,49 μg/ml (90 mg).
English: The beneficial effect of ustekinumab on clinical response, mucosal healing and clinical remission was observed in induction and in maintenance both in patients who failed conventional therapy but not a biologic therapy, as well as in those who had failed at least one prior TNFα antagonist therapy including in patients with a primary non-response to TNFα antagonist therapy.
Slovenian: Ugoden učinek ustekinumaba na klinični odziv, zacelitev sluznice in klinično remisijo so opazili pri indukcijskem in vzdrževalnem zdravljenju tako pri bolnikih z neuspešnim konvencionalnim zdravljenjem, ne pa neuspešnim zdravljenjem z biološkim zdravilom, kot tudi pri tistih z neuspešnim predhodnim zdravljenjem z najmanj enim od zaviralcev TNFα, kar vključuje bolnike, ki so primarno neodzivni na zdravljenje z zaviralci TNFα.
English: PASI 75 responders PASI 90 responders PASI 100 responders CDLQI
Slovenian: Odziv PASI 75 Odziv PASI 90 Odziv PASI 100 CDLQI CDLQI 0 ali 1
English: Caution should be exercised when considering the use of STELARA in patients with a chronic infection or a history of recurrent infection (see section 4.3).
Slovenian: Ko razmišljate o uporabi zdravila STELARA pri bolnikih s kronično okužbo ali ponavljajočimi se okužbami v anamnezi, je potrebna previdnost (glejte poglavje 4.3).
English: • Serious allergic reactions (‘anaphylaxis') are rare in people taking Stelara (may affect up to 1 in 1,000 people).
Slovenian: • Hude alergijske reakcije (‘anafilaksija') so pri bolnikih, ki jemljejo zdravilo Stelara, redke (pojavijo se lahko pri največ 1 od 1.000 bolnikov).
English: • It is preferable to avoid the use of Stelara in pregnancy.
Slovenian: • Uporaba zdravila Stelara ni priporočljiva med nosečnostjo.
English: Health-related quality of life was assessed by Inflammatory Bowel Disease Questionnaire (IBDQ) and SF-36 questionnaires.
Slovenian: Z zdravjem povezano kakovost življenja so ocenjevali z vprašalniki za oceno vnetnih bolezni črevesja (IBDQ - Inflammatory Bowel Disease Questionnaire) in SF-36 (Short Form-36).
English: The safety and efficacy of ustekinumab was assessed in 1,996 patients in two randomised, double-blind, placebo-controlled studies in patients with moderate to severe plaque psoriasis and who were candidates for phototherapy or systemic therapy.
Slovenian: Varnost in učinkovitost ustekinumaba so ocenili pri 1.996 bolnikih v dveh randomiziranih, dvojno slepih in s placebom nadzorovanih študijah pri bolnikih z zmerno do hudo psoriazo s plaki, ki so bili kandidati za fototerapijo ali sistemsko terapijo.