FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of Benlysta administered subcutaneously was evaluated in a randomised, double-blind, placebo-controlled 52-week Phase III study (HGS1006-C1115; BEL112341) in 836 adult patients with a clinical diagnosis of SLE according to the American College of Rheumatology classification criteria.
Croatian: Djelotvornost supkutano primijenjenog lijeka Benlysta ocjenjivala se u 52-tjednom randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze III (HGS1006-C1115; BEL112341) provedenom u 836 odraslih bolesnika s kliničkom dijagnozom SLE-a prema klasifikacijskim kriterijima American College of Rheumatology.
English: • Ask your doctor or pharmacist for instructions on how to properly dispose of a used pen or container of used pens.
Croatian: • Pitajte svog liječnika ili ljekarnika kako pravilno zbrinuti upotrijebljenu brizgalicu ili spremnik s upotrijebljenim brizgalicama.
English: The safety and efficacy of Benlysta was evaluated in a randomised, double-blind, placebo-controlled, 52-week study (PLUTO) in 93 paediatric patients with a clinical diagnosis of SLE according to the ACR classification criteria.
Croatian: Sigurnost i djelotvornost lijeka Benlysta ocjenjivale su se u randomiziranom, dvostruko slijepom, placebom kontroliranom 52-tjednom ispitivanju (PLUTO) koje je obuhvatilo 93 pedijatrijska bolesnika s kliničkom dijagnozom SLE-a prema klasifikacijskim kriterijima ACR-a.
English: Leucopenia: The incidence of leucopenia reported as an adverse event was 3% in the group receiving Benlysta and 2% in the group receiving placebo.
Croatian: Leukopenija: Incidencija leukopenije koja je prijavljena kao štetni događaj iznosila je 3% u skupini koja je primala lijek Benlysta te 2% u skupini koja je primala placebo.
English: During clinical development, Benlysta was studied in a limited number of SLE patients with mild (creatinine clearance [CrCl] ≥60 and <90 ml/min), moderate (CrCl ≥30 and <60 ml/min), or severe (CrCl ≥15 and <30 ml/min) renal impairment: 121 patients with mild renal impairment and 30 patients with moderate renal impairment received Benlysta subcutaneously; 770 patients with mild renal impairment, 261 patients with moderate renal impairment and 14 patients with severe renal impairment received Benlysta intravenously.
Croatian: Tijekom kliničkog razvoja, Benlysta je bila ispitivana u ograničenog broja bolesnika sa SLE-om i blagim (klirens kreatinina [CrCl] ≥ 60 i < 90 ml/min), umjerenim (CrCl ≥ 30 i < 60 ml/min) ili teškim (CrCl ≥ 15 i < 30 ml/min) oštećenjem funkcije bubrega: 121 bolesnik s blagim oštećenjem funkcije bubrega i 30 bolesnika s umjerenim oštećenjem funkcije bubrega primali su lijek Benlysta supkutano, dok je 770 bolesnika s blagim oštećenjem funkcije bubrega, 261 bolesnik s umjerenim oštećenjem funkcije bubrega i 14 bolesnika s teškim oštećenjem funkcije bubrega primalo lijek Benlysta intravenski.
English: Benlysta treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of SLE.
Croatian: Liječenje lijekom Benlysta treba započeti i nadzirati kvalificirani liječnik s iskustvom u dijagnostici i liječenju SLE-a.
English: Gather and check supplies Gather supplies
Croatian: Prikupite i pregledajte pribor Prikupite pribor
English: Patients with hepatic impairment are unlikely to require dose adjustment (see section 5.2).
Croatian: Malo je vjerojatno da će za bolesnike s oštećenjem jetrene funkcije biti potrebna prilagodba doze (vidjeti dio 5.2).
English: After about 7 years, a 28% median reduction in IgG levels was observed, with 1.6% of subjects experiencing a decrease in IgG levels to below 400 mg/dl. Over the course of the study, the reported incidence of AEs generally remained stable or declined.
Croatian: Nakon otprilike 7 godina, zamijećeno je smanjenje razine IgG protutijela s medijanom od 28%, a u 1,6% ispitanika je zabilježeno sniženje razine IgG ispod 400 mg/dl.
English: Each vial contains 120 mg belimumab (80 mg/ml after reconstitution)
Croatian: Jedna bočica sadrži 120 mg belimumaba (80 mg/ml nakon rekonstitucije)
English: Do not touch this area again before giving the injection.
Croatian: Nemojte ponovno dodirivati to područje do injiciranja.
English: ≥1/10,000 to <1/1000
Croatian: ≥ 1/10 000 i < 1/1000
English: The incidence of infusion reactions and hypersensitivity reactions after intravenous administration occurring within 3 days of an infusion was 12% in the group receiving Benlysta and 10% in the group receiving placebo, with 1.2% and 0.3%, respectively, requiring permanent treatment discontinuation.
Croatian: Incidencija infuzijskih reakcija i reakcija preosjetljivosti koje su se javile unutar 3 dana nakon intravenske infuzije bila je 12% u skupini koja je primala lijek Benlysta te 10% u skupini koja je primala placebo, uz 1,2% bolesnika u prvoj, odnosno 0,3% u drugoj skupini koji su zahtijevali trajni prekid liječenja.
English: Clean the injection site by wiping it with an alcohol swab (Figure 5).
Croatian: Da biste očistili mjesto za injiciranje, obrišite ga tupferom natopljenim alkoholom (Slika 5).
English: The recommended dose regimen is 10 mg/kg Benlysta on Days 0, 14 and 28, and at 4-week intervals thereafter.
Croatian: Preporučeni režim doziranja lijekom Benlysta je 10 mg/kg, na 0., 14. i 28. dan, te u 4-tjednim intervalima nakon toga.
English: During clinical development Benlysta was studied in patients with SLE and renal impairment (261 subjects with moderate renal impairment, creatinine clearance ≥30 and <60 ml/min; 14 subjects with severe renal impairment, creatinine clearance ≥15 and <30 ml/min).
Croatian: Tijekom kliničkog razvoja, Benlysta je bila ispitivana u bolesnika sa SLE-om i oštećenjem funkcije bubrega (261 ispitanika s umjerenim oštećenjem bubrega, klirens kreatinina ≥30 i <60 ml/min; 14 ispitanika s teškim oštećenjem bubrega, klirens kreatinina ≥15 i <30 ml/min).
English: 12- to 17-year-old group: infections were reported in 22/43 patients receiving Benlysta and 25/37 patients receiving placebo, and serious infections were reported in 3/43 patients receiving Benlysta and 3/37 patients receiving placebo.
Croatian: Bolesnici u dobi od 12 do 17 godina: Infekcije su prijavljene u 22/43 bolesnika koja su primala lijek Benlysta i 25/37 bolesnika koji su primali placebo, dok su ozbiljne infekcije prijavljene u 3/43 bolesnika koja su primala lijek Benlysta i 3/37 bolesnika koji su primali placebo.
English: • alcohol swab (not included in the pack)
Croatian: • tupfer natopljen alkoholom (nije uključen u pakiranje)
English: • Do not put the ring cap back onto the pen.
Croatian: • Nemojte vraćati zatvarač s prstenom na brizgalicu.
English: No clinically significant reduction in systemic clearance as a result of renal impairment was observed.
Croatian: Nije opaženo klinički značajno smanjenje sistemskog klirensa zbog oštećenja bubrežne funkcije.
English: Push the plunger all the way down
Croatian: Pritisnite klip do kraja
English: You inject Benlysta under your skin in your stomach area (abdomen) or upper leg (thigh).
Croatian: Lijek Benlysta injicira se pod kožu na području trbuha (abdomena) ili natkoljenice (bedra).
English: The majority of patients were also receiving one or more of the following concomitant treatments for SLE: corticosteroids, immunomodulatory medicinal products, anti-malarials, non-steroidal anti-inflammatory medicinal products.
Croatian: Većina bolesnika istodobno je dobivala jedan ili više lijekova za SLE: kortikosteroide, imunomodulatorne lijekove, antimalarike, nesteroidne protuupalne lijekove.
English: Benlysta can cause a reaction to the injection, or an allergic (hypersensitivity) reaction.
Croatian: Benlysta može uzrokovati reakciju na injekciju ili alergijsku reakciju (reakciju preosjetljivosti).
English: The incidence of post-injection systemic reactions and hypersensitivity reactions occurring within 3 days of subcutaneous administration was 7% in the group receiving Benlysta and 9% in the group receiving placebo.
Croatian: Incidencija sistemskih reakcija i reakcija preosjetljivosti koje su se javile unutar 3 dana nakon supkutane injekcije iznosila je 7% u skupini koja je primala lijek Benlysta te 9% u skupini koja je primala placebo.
English: In the two Phase III studies in adults, 4 of the 563 (0.7%) patients in the 10 mg/kg group and 27 out of 559 (4.8%) patients in the 1 mg/kg group tested positive for persistent presence of anti-belimumab antibodies.
Croatian: U dva ispitivanja faze III provedena u odraslih, 4 od 563 (0,7%) bolesnika u skupini koja je primala lijek Benlysta 10 mg/kg, te 27 od 559 (4,8%) bolesnika u skupini koja je primala lijek Benlysta u dozi od 1 mg/kg, bilo je pozitivno na stalnu prisutnost anti-belimumab protutijela.
English: The study was conducted in the US, South America, Europe, and Asia.
Croatian: SAD-u, Južnoj Americi, Europi i Aziji.
English: This is important so that you can confirm a complete dose.
Croatian: To je važno da biste potvrdili primjenu cijele doze. (Slika 7)
English: 5- to 11-year-old group: infections were reported in 8/10 patients receiving Benlysta and 3/3 patients receiving placebo, and serious infections were reported in 1/10 patients receiving Benlysta and 2/3 patients receiving placebo (see section 4.4).
Croatian: Bolesnici u dobi od 5 do 11 godina: Infekcije su prijavljene u 8/10 bolesnika koji su primali lijek Benlysta i 3/3 bolesnika koja su primala placebo, dok su ozbiljne infekcije prijavljene u 1/10 bolesnika koji su primali lijek Benlysta i 2/3 bolesnika koja su primala placebo (vidjeti dio 4.4).
English: In a pooled analysis of the two studies, the percentage of patients receiving >7.5 mg/day prednisone (or equivalent) at baseline, whose average corticosteroid dose was reduced by at least 25% to a dose equivalent to prednisone ≤7.5 mg/day during Weeks 40 through 52, was 17.9% in the group receiving Benlysta and 12.3% in the group receiving placebo (p=0.0451).
Croatian: U skupnoj analizi dvaju ispitivanja, postotak bolesnika koji su primali >7,5 mg/dan prednizona (ili ekvivalenta) na početku ispitivanja, čija je prosječna doza kortikosteroida bila smanjena za barem25%, na dozu ekvivalentnu ≤7,5 mg prednizona dnevno, tijekom 40. do 52. tjedna, iznosio je 17,9% u skupini koja je primala lijek Benlysta, te 12,3% u skupini koja je primala placebo (p=0,0451).
English: Steady-state geometric mean Cmax, Cmin, and AUC values were 305 µg/mL, 42 µg/mL, and 2569 day•µg/mL in the 5- to 11-year-old-group, and 317 µg/mL, 52 µg/mL, and 3126 day•µg/mL in the 12- to 17-year-old-group (n=43).
Croatian: 305 µg/ml, 42 µg/ml odnosno 2569 dana•µg/ml u dobnoj skupini od 5 do 11 godina te 317 µg/ml, 52 µg/ml odnosno 3126 dana•µg/ml u dobnoj skupini od 12 do 17 godina (n=43).
English: Patients should be instructed to seek immediate medical attention if they experience any of these symptoms.
Croatian: Bolesnike treba upozoriti da u slučaju pojave bilo kojeg od tih simptoma odmah potraže medicinsku pomoć.
English: The efficacy of Benlysta administered intravenously was evaluated in 2 randomized, double-blind, placebo-controlled studies in 1,684 patients with a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria.
Croatian: Djelotvornost intravenski primijenjenog lijeka Benlysta bila je ocijenjena u dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja u 1684 bolesnika s kliničkom dijagnozom SLE-a prema klasifikacijskim kriterijima American College of Rheumatology (ACR).
English: Once reconstitution is complete, the solution should be opalescent and colourless to pale yellow and without particles.
Croatian: Nakon što je rekonstitucija završena, otopina bi trebala biti opalescentna i bezbojna do blijedo žuta i bez čestica.
English: The currently available data are described in the Summary of Product Characteristics of Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion.
Croatian: Trenutno dostupni podaci opisani su u sažetku opisa svojstava lijeka za lijek Benlysta 120 mg i 400 mg prašak za koncentrat za otopinu za infuziju.
English: Tell your doctor if any of these may apply to you.
Croatian: Obavijestite svog liječnika ako se išta od ovoga odnosi na Vas.
English: • Clean the injection site by wiping it with an alcohol swab (Figure 5).
Croatian: • Da biste očistili mjesto za injiciranje, obrišite ga tupferom natopljenim alkoholom (Slika 5).
English: Benlysta 200 mg weekly (n=554)
Croatian: Benlysta 200 mg tjedno (n=554)
English: Belimumab is a human, IgG1λ monoclonal antibody, produced in a mammalian cell line (NS0) by recombinant DNA technology.
Croatian: Belimumab je humano, IgG1λ monoklonsko protutijelo, proizvedeno na staničnoj liniji sisavaca (NS0)
English: Safety data in children younger than 12 years of age (n=10) are limited.
Croatian: 12 godina (n=10) su ograničeni.
English: In a randomised, double-blind, placebo-controlled, post-marketing study with Benlysta 10 mg/kg administered intravenously, serious psychiatric events were reported in 1.0% (20/2002) of patients receiving Benlysta and 0.3% (6/2001) of patients receiving placebo.
Croatian: U randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju intravenske primjene lijeka Benlysta u dozi od 10 mg/kg koje je provedeno nakon stavljanja lijeka u promet, ozbiljni psihijatrijski događaji prijavljeni su u 1,0% (20/2002) bolesnika koji su primali lijek Benlysta te 0,3% (6/2001) onih koji su primali placebo.
English: Clean the injection site
Croatian: Očistite mjesto za injiciranje
English: Also contains: arginine hydrochloride, histidine, histidine monohydrochloride, polysorbate 80, sodium chloride, water for injections.
Croatian: Sadrži i: argininklorid, histidin, histidinklorid, polisorbat 80, natrijev klorid, vodu za injekcije.
English: Adverse reactions are listed below by MedDRA system organ class and by frequency.
Croatian: Nuspojave su navedene u tablici ispod, klasificirane prema MedDRA klasifikaciji organskih sustava i učestalosti.
English: In the open-label extension phase there was one fatal infection in a patient receiving Benlysta.
Croatian: U otvorenom nastavku ispitivanja zabilježena je jedna infekcija sa smrtnim ishodom u bolesnika liječenog lijekom
English: The safety data presented include data beyond Week 52 in some patients.
Croatian: Prikazani podaci o sigurnosti uključuju podatke i nakon 52. tjedna u nekih bolesnika.Uključeni su i podaci o slučajevima prijavljenima nakon stavljanja lijeka u promet.
English: The recommended dose is 200 mg (complete contents of one syringe) once a week, injected under your skin on the same day each week.
Croatian: Preporučena doza je 200 mg (sav sadržaj jedne brizgalice) jedanput tjedno, a injicira se pod kožu (supkutano) isti dan svakog tjedna.
English: Benlysta 200 mg belimumab SC
Croatian: Benlysta 200 mg belimumab s.c.
English: Benlysta has not been studied in combination with other B cell targeted therapy or intravenous cyclophosphamide.
Croatian: Benlysta nije ispitivana u kombinaciji s drugom ciljanom terapijom za B limfocite ili intravenskim ciklofosfamidom.
English: Contents of the pack and other information Step-by-step instructions for using the pre-filled pen
Croatian: Sadržaj pakiranja i druge informacije Upute za uporabu napunjene brizgalice korak po korak.
English: • Remove one sealed tray containing a pre-filled pen from the refrigerator.
Croatian: • Izvadite jedan zatvoreni podložak s napunjenom brizgalicom iz hladnjaka.
English: Patients were on a stable SLE treatment regimen consisting of (alone or in combination): corticosteroids, anti-malarials, NSAIDs or other immunosuppressives.
Croatian: Bolesnici su bili na stabilnoj terapiji za SLE koja se sastojala od (samih ili u kombinaciji): kortikosteroida, antimalaričkih lijekova, nesteroidnih protuupalnih lijekova ili drugih imunosupresiva.
English: • no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B
Croatian: • bez novih bodova zahvaćenosti organskih sustava kategorije BILAG (British Isles Lupus
English: Benlysta can cause a reaction to the infusion, or an allergic (hypersensitivity) reaction.
Croatian: Benlysta može uzrokovati reakciju na infuziju ili alergijsku reakciju (reakciju preosjetljivosti).
English: Patients were on a stable SLE treatment regimen (standard of care) consisting of any of the following (alone or in combination): corticosteroids, anti-malarials, NSAIDs or other immunosuppressives.
Croatian: Bolesnici su bili na stabilnoj terapiji za SLE (standardna skrb) koja se sastojala od bilo kojih od sljedećih lijekova (samih ili u kombinaciji): kortikosteroida, antimalaričkih lijekova, nesteroidnih protuupalnih lijekova ili drugih imunosupresiva.
English: The median time to the first flare was delayed in the pooled group receiving Benlysta compared to the group receiving placebo (110 vs 84 days, hazard ratio=0.84, p=0.012).
Croatian: Medijan vremena do prve egzacerbacije bio je odgođen u skupnoj skupini bolesnika koji su primali lijek Benlysta u usporedbi sa skupinom koja je primala placebo (110 naspram 84 dana, omjer hazarda=0,84; p=0,012).
English: Serious infections occurred in 5% of patients in both groups receiving Benlysta or placebo; serious opportunistic infections accounted for 0.4% and 0% of these, respectively.
Croatian: Ozbiljne infekcije javile su se u 5% bolesnika i u skupini koja je primala lijek Benlysta i u onoj koja je primala placebo; ozbiljne oportunističke infekcije činile su 0,4% odnosno
English: Clinically significant hypersensitivity reactions associated with Benlysta administered subcutaneously and requiring permanent treatment discontinuation were reported in 0.2% of patients receiving Benlysta and in no patients receiving placebo.
Croatian: Klinički značajne reakcije preosjetljivosti povezane sa supkutano primijenjenim lijekom Benlysta koje su zahtijevale trajni prekid liječenja prijavljene su u 0,2% bolesnika koji su primali lijek Benlysta te niti u jednog bolesnika koji je primao placebo.
English: • The other ingredients are citric acid monohydrate (E330), sodium citrate (E331), sucrose and polysorbate 80.
Croatian: • Drugi sastojci su citratna kiselina hidrat (E330), natrijev citrat (E331), saharoza i polisorbat 80.
English: • Do not recycle or throw the used syringe, or container of used syringes in household waste.
Croatian: • Nemojte reciklirati upotrijebljenu štrcaljku ili spremnik s upotrijebljenim štrcaljkama niti ih baciti u kućni otpad.
English: Do not use if the expiry date has passed
Croatian: Nemojte upotrijebiti brizgalicu ako joj je istekao rok valjanosti
English: In the subcutaneous study where serum samples from more than 550 patients with SLE were tested, no antibelimumab antibodies were detected during or after treatment with belimumab 200 mg subcutaneously.
Croatian: 550 bolesnika sa SLE-om, nisu pronađena protutijela na belimumab ni tijekom ni nakon liječenja belimumabom u supkutanoj dozi od 200 mg.
English: At baseline 62.2% of patients had high disease activity (SELENA SLEDAI score ≥10), 88% of patients had mucocutaneous, 78% had musculoskeletal, 8% had haematological, 12% had renal, and 8% had vascular organ involvement.
Croatian: Na početku ispitivanja je 62,2% bolesnika imalo visoki stupanj aktivnosti bolesti (SELENA SLEDAI rezultat > 10), u 88% bolesnika zahvaćene su bile koža i sluznice, u 78% bolesnika mišićno-koštani sustav, u 8% hematološki sustav, u 12% bubrezi te u 8% vaskularni sustav.
English: • Look in the inspection window to check that the Benlysta solution is colourless to slightly yellow in colour.
Croatian: • Pogledajte kroz prozorčić za provjeru kako biste provjerili je li otopina lijeka Benlysta bezbojna do blijedožuta. (Slika 3)
English: The true occurrence of neutralising antibodies and non-specific anti-drug antibody in the study population is therefore not known.
Croatian: Stoga prava pojava neutralizirajućih protutijela i nespecifičnih ADA u krvi ispitanika nije poznata.
English: Adverse reactions were reported in 87% of Benlysta-treated patients and 90% of placebo-treated patients.
Croatian: Nuspojave su bile prijavljene u 87% bolesnika liječenih lijekom Benlysta, te u 90% bolesnika liječenih placebom.
English: Age did not affect belimumab exposure in the subcutaneous population pharmacokinetic analysis.
Croatian: Dob nije utjecala na izloženost belimumabu u farmakokinetičkoj analizi populacije liječene supkutanom formulacijom.
English: The other ingredients are arginine hydrochloride, histidine, histidine monohydrochloride, polysorbate 80, sodium chloride, water for injections.
Croatian: Drugi sastojci su argininklorid, histidin, histidinklorid, polisorbat 80, natrijev klorid, voda za injekcije.
English: Components of SLE responder index
Croatian: Komponente indeksa odgovora SLE-a
English: Infections: The overall incidence of infections in intravenous and subcutaneous studies was 63% in both groups receiving Benlysta or placebo.
Croatian: Infekcije: Ukupna incidencija infekcija u ispitivanjima intravenske i supkutane primjene iznosila je 63% i u skupini koja je primala lijek Benlysta i u onoj koja je primala placebo.
English: Continue with the new weekly schedule from that day.
Croatian: Nastavite primjenjivati lijek jedanput tjedno prema novom rasporedu, počevši od tog dana.
English: Therefore, no dose adjustment is recommended for patients with renal impairment.
Croatian: Prema tome, ne preporučuje se prilagođavanje doze za bolesnike s oštećenjem bubrežne funkcije.
English: Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy (see section 5.1).
Croatian: Benlysta je indicirana kao dodatna terapija u bolesnika u dobi od 5 ili više godina s aktivnim sistemskim eritematoznim lupusom (SLE) s pozitivnim autoprotutijelima, koji imaju visok stupanj aktivnosti bolesti (npr. pozitivna anti-dsDNK protutijela i snižene vrijednosti komplementa) unatoč standardnoj terapiji (vidjeti dio 5.1).
English: Choose and clean the injection site Choose the injection site
Croatian: 3. Odaberite i očistite mjesto za injiciranje
English: Odds ratio (95% CI) vs Placebo *The five PRINTO/ACR components were percent change at Week 52 in: Parent's Global Assessment (Parent GA), PGA, SELENA SLEDAI score, 24-hour proteinuria, and, Paediatric Quality of Life Inventory - Generic Core Scale (PedsQL GC) physical functioning domain score.
Croatian: *Pet komponenti odgovora prema PRINTO/ACR kriterijima činile su postotne promjene sljedećih rezultata u 52. tjednu: opće ocjene roditelja, opće ocjene liječnika (PGA), SELENA-SLEDAI rezultata, vrijednosti proteina u 24-satnoj mokraći te rezultata za tjelesnu funkciju na osnovnoj općoj ljestvici za ocjenu kvalitete života pedijatrijskih bolesnika (engl.
English: Serious depression was reported in 0.6% (4/674) of patients receiving Benlysta 10 mg/kg and 0.3% (2/675) of patients receiving placebo.
Croatian: Ozbiljna depresija prijavljena je u 0,6% (4/674) bolesnika koji su primali lijek Benlysta u dozi od 10 mg/kg te 0,3% (2/675) onih koji su primali placebo.
English: • Keep in the carton in order to protect from light.
Croatian: • Čuvati u kutiji radi zaštite od svjetlosti.
English: Belimumab has been studied in a limited number of SLE patients with renal impairment.
Croatian: Belimumab je ispitan na ograničenom broju bolesnika sa SLE-om i oštećenjem funkcije bubrega.
English: Prednisone reduction by ≥25% from baseline to
Croatian: Smanjenje prednizona ≥ 25% od početne vrijednosti,
English: No specific studies with Benlysta have been conducted in patients with hepatic impairment.
Croatian: Nisu provedena specifična ispitivanja lijeka Benlysta u bolesnika s oštećenjem funkcije jetre.