FrancophonIA/ELRC3.0 huggingface dataset:
English: At baseline 52% of patients had high disease activity (SELENA SLEDAI score ≥10), 59% of patients had mucocutaneous, 60% had musculoskeletal, 16% had haematological, 11% had renal and 9% had vascular organ domain involvement (BILAG A or B at baseline).
Croatian: Na početku ispitivanja je 52% bolesnika imalo visoki stupanj aktivnosti bolesti (SELENA SLEDAI rezultat >10), u 59% bolesnika zahvaćene su bile koža i sluznice, u 60% bolesnika mišićno-koštani sustav, u 16% hematološki sustav, u 11% bubrezi, te u 9% vaskularni sustav (BILAG A ili B na početku ispitivanja).
English: EU/1/11/700/003 1 pre-filled pen EU/1/11/700/004 4 pre-filled pens EU/1/11/700/005 12 (3x4) pre-filled pens (multipack) EU/1/11/700/006 1 pre-filled syringe EU/1/11/700/007 4 pre-filled syringes
Croatian: EU/1/11/700/003 1 napunjena brizgalica EU/1/11/700/004 4 napunjene brizgalice EU/1/11/700/005 12 (3 x 4) napunjenih brizgalica (višestruko pakiranje) EU/1/11/700/006 1 napunjena štrcaljka EU/1/11/700/007 4 napunjene štrcaljke
English: Your first injection with the Benlysta pre-filled syringe will be supervised by your doctor or nurse.
Croatian: Prva injekcija lijeka Benlysta napunjenom štrcaljkom primijenit će se pod nadzorom liječnika ili medicinske sestre.
English: Discard the solution if any particulate matter or discoloration is observed.
Croatian: Bacite otopinu ako primijetite bilo kakve čestice ili promjenu boje.
English: People taking medicines that affect their immune system may be more at risk of infections, including a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML).
Croatian: Osobe koje uzimaju lijekove koji djeluju na imunološki sustav mogu imati povećan rizik od infekcija, uključujući rijetku, ali ozbiljnu infekciju koja se zove progresivna multifokalna leukoencefalopatija (PML).
English: Among patients experiencing a severe flare, the median study day of the first severe flare was Day 159.5 in the Benlysta group and Day 82 in the placebo group.
Croatian: Među bolesnicima koji su imali tešku egzacerbaciju bolesti medijan broja dana u ispitivanju do prve teške egzacerbacije iznosio je 159,5 dana u skupini liječenoj lijekom Benlysta te 82 dana u onoj koja je primala placebo.
English: You should also receive training on how to use the prefilled syringe.
Croatian: Osim toga, morate proći i obuku o tome kako koristiti napunjenu brizgalicu.
English: • if you have a current or long-term infection or if you often get infections (see section 4).
Croatian: Obratite se svom liječniku prije nego primite lijek Benlysta: • ako imate trenutnu ili dugotrajnu infekciju ili ako često imate infekcije (pogledajte dio 4).
English: A single Benlysta pre-filled syringe can be stored at room temperature (up to 25°C) for a maximum of 12 hours - as long as it is protected from light.
Croatian: Pojedinačna napunjena brizgalica s lijekom Benlysta može se čuvati na sobnoj temperaturi (do 25°C) tijekom najviše 12 sati - pod uvjetom da je zaštićena od svjetlosti.
English: Available in pack of 1 pre-filled syringe and pack of 4 pre-filled syringes.
Croatian: Dostupno je pakiranje od 1 napunjene štrcaljke i pakiranje od 4 napunjene štrcaljke.
English: Administration of Benlysta may result in hypersensitivity reactions and infusion reactions which can be severe, and fatal.
Croatian: Primjena lijeka Benlysta može rezultirati reakcijama preosjetljivosti i infuzijskim reakcijama koje mogu biti teške pa i smrtonosne.
English: Median IgG levels at Week 52 were reduced by 11% in patients receiving Benlysta compared with an increase of 0.7% in patients receiving placebo.
Croatian: Medijan vrijednosti IgG-a u 52. tjednu smanjio se za 11% u bolesnika liječenih lijekom Benlysta, dok se u onih koji su primali placebo povećao za 0,7%.
English: Post-hoc analysis has identified high responding subgroups such as those patients with low complement and positive anti-dsDNA at baseline, see Table 2 for results of this example of a higher disease activity group.
Croatian: Post-hoc analiza je identificirala podskupine bolesnika s visokim odgovorom na terapiju, kao što su bolesnici s ishodišno sniženim komplementom i pozitivnim anti-dsDNK, vidjeti Tablicu 2 za rezultate u toj skupini s većom aktivnošću bolesti.
English: Odds ratio (95% CI) vs placebo
Croatian: Omjer izgleda (95% CI) naspram placeba
English: What Benlysta is and what it is used for What you need to know before you are given Benlysta How Benlysta is used
Croatian: Što je Benlysta i za što se koristi Što morate znati prije nego počnete primati lijek Benlysta Kako primjenjivati lijek Benlysta
English: Psychiatric disorders: In the pre-registration intravenous clinical studies, serious psychiatric events were reported in 1.2% (8/674) of patients receiving Benlysta 10 mg/kg and 0.4% (3/675) of patients receiving placebo.
Croatian: Psihijatrijski poremećaji: U predregistracijskim kliničkim ispitivanjima intravenske primjene ozbiljni psihijatrijski događaji prijavljeni su u 1,2% (8/674) bolesnika koji su primali lijek Benlysta u dozi od 10 mg/kg te 0,4% (3/675) bolesnika koji su primali placebo.
English: The recommended dose is 200 mg once weekly, administered subcutaneously.
Croatian: Preporučena doza je 200 mg supkutano jedanput tjedno.
English: Recurrence of clinically significant reactions after initial appropriate treatment of symptoms has also been observed (see sections 4.2 and 4.8).
Croatian: Također je zapažena ponovna pojava klinički značajnih reakcija nakon početno odgovarajućeg zbrinjavanja simptoma (vidjeti dijelove 4.2 i 4.8).
English: Table 3 - Paediatric response rate at Week 52 Response
Croatian: Tablica 3: Stopa odgovora u 52. tjednu u pedijatrijskih bolesnika Odgovor
English: Severe flares were observed in 22.6% of the Benlysta group compared to 42.5% of the placebo group over the 52 weeks of observation (observed treatment difference = 19.9%; hazard ratio= 0.38, 95% CI: 0.18, 0.82).
Croatian: Tijekom 52 tjedna praćenja teške egzacerbacije opažene su u 22,6% bolesnika liječenih lijekom Benlysta u usporedbi s 42,5% onih koji su primali placebo (opažena razlika između liječenja = 19,9%; omjer hazarda = 0,38; 95% CI: 0,18; 0,82).
English: • Do not recycle or throw the used pen, or container of used pens, in household waste.
Croatian: • Nemojte reciklirati upotrijebljenu brizgalicu ili spremnik s upotrijebljenim brizgalicama niti ih baciti u kućni otpad.
English: The most frequently reported adverse reactions (≥5% of patients with SLE treated with Benlysta plus standard of care and at a rate ≥1% greater than placebo) were viral upper respiratory tract infections,
Croatian: Najčešće prijavljene nuspojave (≥ 5% bolesnika sa SLE-om liječenih lijekom Benlysta u kombinaciji sa standardnom terapijom, te sa stopom ≥ 1% višom od placeba), bile su virusne infekcije gornjih dišnih putova, bronhitis i proljev.
English: What Benlysta is and what it is used for Benlysta as an infusion is a medicine used to treat lupus (systemic lupus erythematosus, SLE) in adults and children (5 years of age and older) whose disease is still highly active despite standard treatment.
Croatian: Benlysta za infuziju je lijek koji se primjenjuje za liječenje lupusa (sistemski eritematozni lupus, SLE) u odraslih i djece (u dobi od 5 ili više godina), čija bolest je i dalje visoko aktivna unatoč standardnom liječenju.
English: A single Benlysta pre-filled syringe or pre-filled pen can be stored at temperatures up to a maximum of 25°C for a period of up to 12 hours.
Croatian: Pojedinačna napunjena štrcaljka ili napunjena brizgalica s lijekom Benlysta mogu se čuvati na sobnoj temperaturi do najviše 25°C tijekom najviše 12 sati.
English: Changes in biomarkers were seen in clinical trials with Benlysta administered intravenously.
Croatian: U kliničkim ispitivanjima zamijećene su promjene u biomarkerima kod intravenske primjene lijeka
English: Citric acid monohydrate (E330), sodium citrate (E331), sucrose, polysorbate 80
Croatian: citratna kiselina hidrat (E330), natrijev citrat (E331), saharoza, polisorbat 80
English: You will see the purple indicator start to move through the inspection window.
Croatian: Kroz prozorčić za provjeru vidjet ćete ljubičasti indikator kako se počinje pomicati. (Slika 9)
English: SRI response rate at week 52 (%) Observed treatment difference vs placebo (%)
Croatian: Stopa SRI odgovora u 52. tjednu (%) Opažena razlika u liječenju naspram placeba (%)
English: Available in packs of 1 or 4 pre-filled syringes in each pack.
Croatian: Dostupna je u pakiranjima od 1 ili 4 napunjene štrcaljke.
English: Recurrence of clinically significant reactions after initial appropriate treatment of symptoms has also been observed (see sections 4.4 and 4.8).
Croatian: Također je zapažena ponovna pojava klinički značajnih reakcija nakon početno odgovarajućeg zbrinjavanja simptoma (vidjeti dijelove 4.4 i 4.8).
English: Background medicinal products included corticosteroids (86%; >7.5 mg/day prednisone equivalent 60%), immunosuppressives (46%), and antimalarials (69%).
Croatian: Osnovno liječenje uključivalo je kortikosteroide (86%; 60% bolesnika primalo je dozu od > 7,5 mg/dan ekvivalenta prednizona), imunosupresive (46%) i antimalarike (69%).
English: Observed treatment difference vs placebo (%)
Croatian: Opažena razlika u liječenju naspram placeba (%)
English: 1 ml solution in a type 1 glass syringe with a fixed needle (stainless steel) in a pre-filled pen.
Croatian: 1 ml otopine u staklenoj štrcaljki (staklo tipa 1) s pričvršćenom iglom (nehrđajući čelik) u napunjenoj brizgalici.
English: BLISS-76 and BLISS-52 Pooled
Croatian: BLISS-76 i BLISS-52 skupno
English: Benlysta can make you more likely to get infections, including infection of the urinary tract and airways.
Croatian: Benlysta može povećati vjerojatnost razvoja infekcija, uključujući infekciju mokraćnih i dišnih putova.
English: Benlysta can make you more likely to get infections, including infection of the urinary tract and airways, younger children may be at increased risk.
Croatian: Benlysta može povećati vjerojatnost razvoja infekcija, uključujući infekciju mokraćnih i dišnih putova, a rizik može biti povećan u mlađe djece.
English: • Do not touch this area again before giving the injection.
Croatian: • Nemojte ponovno dodirivati to područje do injiciranja.
English: No dose adjustment is recommended for underweight or obese subjects.
Croatian: Ne preporučuje se prilagodba doze za pothranjene ili pretile bolesnike.
English: EU/1/11/700/001 1 vial - 120 mg EU/1/11/700/002 1 vial - 400 mg
Croatian: EU/1/11/700/001 1 bočica - 120 mg EU/1/11/700/002 1 bočica - 400 mg
English: Concomitant use with B cell targeted therapy or cyclophosphamide
Croatian: Istodobna primjena s ciljanom terapijom za B limfocite ili ciklofosfamidom
English: Multipack:12 pre-filled pens (3 cartons of 4 pre-filled pens).
Croatian: Višestruko pakiranje: 12 napunjenih brizgalica (3 kutije s 4 napunjene brizgalice).
English: None known.
Croatian: Nema poznatih inkompatibilnosti.
English: These may affect up to 1 in 100 people: • itchy, bumpy rash (hives), skin rash.
Croatian: Mogu se javiti u do 1 na 100 osoba: • izdignut osip praćen svrbežom (koprivnjača), kožni osip
English: SLE responder index
Croatian: Indeks odgovora SLE-a
English: In the subcutaneous clinical study, which excluded patients with a history of psychiatric disorders, serious psychiatric events were reported in 0.2% (1/556) of patients receiving Benlysta and in no patients receiving placebo.
Croatian: U kliničkom ispitivanju supkutane primjene, u kojem nisu mogli sudjelovati bolesnici s psihijatrijskim poremećajima u anamnezi, ozbiljni psihijatrijski događaji prijavljeni su u 0,2% (1/556) bolesnika koji su primali lijek Benlysta, dok u onih koji su primali placebo nije zabilježen nijedan takav događaj.
English: Follow these instructions on how to use the pre-filled syringe correctly.
Croatian: Slijedite ove upute za pravilnu uporabu napunjene brizgalice.
English: Patients were excluded from the study if they had severe active central nervous system lupus or severe active lupus nephritis.
Croatian: U ispitivanje nisu bili uključeni bolesnici s teškim aktivnim lupusom središnjeg živčanog sustava ili teškim aktivnim lupusnim nefritisom.
English: Table 2: Patients with low complement and positive anti-dsDNA at baseline Subgroup
Croatian: Tablica 2: Bolesnici s ishodišno sniženim vrijednostima komplementa i pozitivnim anti-dsDNK Podskupina
English: Injection site reactions: In the subcutaneous trial, the frequency of injection site reactions was 6.1% (34/556) and 2.5% (7/280) for patients receiving Benlysta and placebo, respectively.
Croatian: Reakcije na mjestu injiciranja: Učestalost reakcija na mjestu injiciranja u ispitivanju supkutane primjene iznosila je 6,1% (34/556) u bolesnika koji su primali lijek Benlysta te 2,5% (7/280) u bolesnika koji su primali placebo.
English: Benlysta is supplied as a white to off-white powder for solution for infusion, in a glass vial with a siliconised rubber stopper and a flip-off aluminium seal.
Croatian: Benlysta je bijeli do gotovo bijeli prašak za otopinu za infuziju, dostupan u staklenoj bočici zatvorenoj silikoniziranim gumenim čepom i zaštitnim aluminijskim prstenom.
English: In adult patients with hypergammaglobulinemia, normalization of IgG levels was observed by Week 52 in 49% and 20% of patients receiving Benlysta and placebo, respectively.
Croatian: U odraslih bolesnika s hipergama-globulinemijom, normalizacija razine IgG-a bila je do 52. tjedna opažena u 49% bolesnika koji su primali lijek Benlysta, te u 20% bolesnika koji su primali placebo.
English: Benlysta 120 mg powder for concentrate for solution for infusion Type 1 glass vials (5 ml), sealed with a siliconised chlorobutyl rubber stopper and a flip-off aluminum seal containing 120 mg of powder.
Croatian: Benlysta 120 mg prašak za koncentrat za otopinu za infuziju Staklene (tip 1) bočice (5 ml), zatvorene silikoniziranim klorobutilnim gumenim čepom i zaštitnim aluminijskim prstenom sadrže 120 mg praška.
English: Dispose and inspect Dispose of the used syringe
Croatian: Bacite i pregledajte Bacite upotrijebljenu štrcaljku
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava često leukopenija
English: The proportion of patients who discontinued treatment due to adverse reactions was 7% for Benlysta-treated patients and 8% for placebo-treated patients.
Croatian: Udio bolesnika koji su prekinuli liječenje zbog nuspojava bio je 7% za bolesnike liječene lijekom Benlysta te 8% za one liječene placebom.
English: Caution is however recommended in patients with severe renal impairment due to the lack of data (see section 5.2).
Croatian: Zbog nedostatka podataka, oprez se ipak savjetuje u bolesnika s teškim oštećenjem bubrežne funkcije (vidjeti dio 5.2).
English: Progressive multifocal leukoencephalopathy (PML) has been reported with Benlysta treatment for SLE.
Croatian: U bolesnika sa SLE-om liječenih lijekom Benlysta prijavljena je progresivna multifokalna leukoencefalopatija (PML).
English: Available in packs of 1 or 4 pre-filled pens and multipack containing 12 single-dose pre-filled pens (3 packs of 4 pre-filled pens).
Croatian: Dostupna su pakiranja od 1 ili 4 napunjene brizgalice i višestruko pakiranje koje sadrži 12 jednodoznih napunjenih brizgalica (3 pakiranja od 4 napunjene brizgalice).
English: Patients should be advised that hypersensitivity reactions are possible, on the day of, or several days after infusion, and be informed of potential signs and symptoms and the possibility of recurrence.
Croatian: Bolesnici bi trebali biti upoznati s mogućnošću pojave reakcija preosjetljivosti na dan primjene infuzije kao i nekoliko dana nakon toga, i biti informirani o mogućim znakovima i simptomima takvih reakcija te mogućnosti njihove ponovljene pojave.
English: Hepatic impairment: No specific studies have been conducted to examine the effects of hepatic impairment on the pharmacokinetics of belimumab.
Croatian: Oštećenje funkcije jetre: Nisu provedena posebna ispitivanja u svrhu ocjenjivanja učinaka oštećenja jetrene funkcije na farmakokinetiku belimumaba.
English: Caution should be exercised if Benlysta is co-administered with other B cell targeted therapy or cyclophosphamide.
Croatian: Potreban je oprez kad se Benlysta primjenjuje istodobno s drugom ciljanom terapijom za B limfocite ili ciklofosfamidom.
English: Increased exposure for obese subjects receiving 10 mg/kg belimumab did not lead to an overall increase in AE rates or serious AEs compared to obese subjects receiving placebo.
Croatian: Povećana izloženost u pretilih osoba koje su primale 10 mg/kg belimumaba nije dovela do ukupnog porasta stope nuspojava ili ozbiljnih nuspojava,
English: The median time to the first severe flare among patients having a severe flare was delayed in patients receiving Benlysta compared with placebo (171 days vs. 118 days).
Croatian: Medijan vremena do prve teške egzacerbacije među bolesnicima koji su doživjeli tešku egzacerbaciju bio je dulji u bolesnika koji su primali lijek Benlysta nego u onih koji su primali placebo (171 dan naspram 118 dana).
English: In patients with anti-dsDNA antibodies at baseline, median anti-dsDNA antibodies levels at Week 52 were reduced by 56% in patients receiving Benlysta compared with 41% in patients receiving placebo.
Croatian: Među bolesnicima koji su imali anti-dsDNK protutijela na početku ispitivanja, medijan vrijednosti anti-dsDNK protutijela u 52. tjednu smanjio se za 56% u bolesnika liječenih lijekom Benlysta, u usporedbi s 41% u onih koji su primali placebo.
English: • Peel back the film of the tray and remove the pre-filled syringe by grasping the middle of the body.
Croatian: • Skinite pokrovni film s podloška, uhvatite napunjenu štrcaljku za srednji dio tijela i izvadite je.
English: In patients with low complement levels, normalization of C3 and C4 was observed by Week 52 in 38% and 44% of patients receiving Benlysta and in 17% and 18% of patients receiving placebo, respectively.
Croatian: U bolesnika s niskom razinom komplementa, normalizacija razine C3 i C4 opažena je do 52. tjedna u 38% odnosno 44% bolesnika koji su primali lijek Benlysta, te u 17% odnosno 18% bolesnika koji su primali placebo.
English: An additional, previously identified serologically active group, those patients with low complement and positive anti-dsDNA at baseline, also demonstrated a greater relative response, see Table 2 for results of this example of a higher disease activity group.
Croatian: Veći relativan odgovor opažen je i u dodatnoj, prethodno identificiranoj serološki aktivnoj skupini bolesnika s ishodišno sniženim komplementom i pozitivnim anti-dsDNK; vidjeti Tablicu 2 za rezultate u toj skupini s većom aktivnošću bolesti.
English: What you need to know before you are given Benlysta Do not receive Benlysta:
Croatian: Što morate znati prije nego počnete primati lijek Benlysta Nemojte primiti lijek Benlysta:
English: Background medicinal products included corticosteroids (96%; >7.5 mg/day 69%), immunosuppressives (42%), and anti-malarials
Croatian: Osnovno liječenje uključivalo je kortikosteroide (96%; 69% ih je primalo >7,5 mg/dan), imunosupresive (42%)
English: • if you have had an organ transplant, or a bone marrow or stem cell transplant
Croatian: • ako Vam je transplantiran organ, koštana srž ili matične stanice
English: The risk of severe flares was reduced by 49% during the 52 weeks of observation in the group receiving Benlysta compared with the group receiving placebo (hazard ratio=0.51; p=0.0004).
Croatian: Rizik od teških egzacerbacija se tijekom 52-tjednog razdoblja promatranja smanjio za 49% u skupini koja je primala lijek Benlysta u odnosu na onu koja je primala placebo (omjer hazarda = 0,51; p = 0,0004).
English: Benlysta demonstrated improvement in fatigue compared with placebo measured by the FACIT-Fatigue Scale.
Croatian: Primjena lijeka Benlysta pokazala je poboljšanje po pitanju umora u odnosu na placebo, mjereno po FACIT-Fatigue ljestvici.
English: Severe flares were observed in 10.6% of patients in the group receiving Benlysta compared with 18.2% of patients in the group receiving placebo over the 52 weeks of observation (observed treatment difference = -7.6%).
Croatian: promatranja opažene u 10,6% bolesnika u skupini liječenoj lijekom Benlysta i 18,2% onih u skupini koja je primala placebo (opažena razlika između liječenja = -7,6%).
English: Infusion or injection-related systemic reactions*, pyrexia
Croatian: Opći poremećaji i reakcije na mjestu primjene često sistemske reakcije povezane s primjenom infuzije ili injekcije*, pireksija
English: These injection site reactions (most commonly pain, erythema, hematoma, pruritus and induration) were mild to moderate in severity.
Croatian: Te reakcije na mjestu injiciranja (najčešće bol, eritem, hematom,
English: Available in packs of 1 or 4 pre-filled pens in each pack and multipacks comprising 12 pre-filled pens (3 packs of 4 pre-filled pens).
Croatian: Dostupna je u pakiranjima od 1 ili 4 napunjene brizgalice te višestrukim pakiranjima koja sadrže 12 napunjenih brizgalica (3 pakiranja s 4 napunjene brizgalice).
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava često migrena
English: The MAH shall provide the 1 year data report on a randomized, double-blind placebo-controlled large safety study, based on a protocol agreed with CHMP.
Croatian: dvostruko slijepog placebom kontroliranog velikog ispitivanja sigurnosti, temeljenog na planu ispitivanja dogovorenom s CHMP-om.
English: Renal impairment: No specific studies have been conducted to examine the effects of renal impairment on the pharmacokinetics of belimumab.
Croatian: Oštećenje funkcije bubrega: Nisu provedena posebna ispitivanja u svrhu ocjenjivanja učinaka oštećenja bubrežne funkcije na farmakokinetiku belimumaba.
English: Once removed from the refrigerator, the pen must be used within 12
Croatian: Nakon što brizgalicu izvadite iz hladnjaka, morate je upotrijebiti unutar 12 sati ili baciti.
English: The mean change of score at Week 52 from baseline is significantly greater with Benlysta compared to placebo (4.70 vs 2.46, p=0.0006).
Croatian: Srednja vrijednost promjene rezultata od početne vrijednosti u 52. tjednu ispitivanja je značajno veća uz lijek Benlysta u odnosu na placebo (4,70 naspram 2,46; p=0,0006).
English: There was no significant impact on efficacy and safety based on weight.
Croatian: Budući da tjelesna težina nije značajno utjecala na djelotvornost i sigurnost, ne preporučuje se prilagođavanje doze.
English: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma Italy
Croatian: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma Italija
English: The median time to the first flare among patients having a flare was delayed in patients receiving Benlysta compared with placebo (190 days vs. 141 days).
Croatian: Medijan vremena do prve egzacerbacije među bolesnicima koji su je doživjeli bio je dulji u bolesnika koji su primali lijek Benlysta nego u onih koji su primali placebo (190 dana naspram 141 dan).
English: BLISS-76 Study only
Croatian: Samo ispitivanje BLISS-76
English: Patient median age was 15 years (range 6 to 17 years).
Croatian: Medijan dobi bolesnika iznosio je 15 godina (raspon:
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmola natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: WARNING: The 5 ml and 20 ml vials are reconstituted with different volumes of diluent, see below: 120 mg vial
Croatian: UPOZORENJE: bočice od 5 ml i od 20 ml rekonstituiraju se s različitim volumenima otapala,
English: The adjusted mean change of score at Week 52 from baseline is significantly greater with Benlysta compared to placebo (4.4 vs. 2.7, p=0.0130).
Croatian: Prilagođena srednja vrijednost promjene rezultata od početne vrijednosti u 52. tjednu ispitivanja značajno je veća uz lijek Benlysta u odnosu na placebo (4,4 naspram 2,7; p=0,0130).