FrancophonIA/ELRC3.0 huggingface dataset:
English: For anti-cardiolipin IgA antibody a 37% reduction at Week 52 was seen (p=0.0003), for anti-cardiolipin IgG antibody a 26% reduction at Week 52 was seen (p=0.0324) and for anti-cardiolipin IgM a 25% reduction was seen (p=NS,
Croatian: Za antikardiolipinsko IgA protutijelo, opaženo je smanjenje od 37% u 52. tjednu (p=0,0003), za antikardiolipinsko protutijelo IgG, opaženo je smanjenje od 26% u 52. tjednu (p=0,0324), a za antikardiolipinsko protutijelo klase IgM, opaženo je smanjenje od 25% (p=NS; 0,46).
English: Comprehensive instructions for subcutaneous administration of Benlysta in a pre-filled pen or pre-filled syringe are provided at the end of the package leaflet (see Step-by-step instructions).
Croatian: Sveobuhvatne upute za supkutanu primjenu lijeka Benlysta napunjenom brizgalicom ili napunjenom štrcaljkom navedene su na kraju upute o lijeku (vidjeti 'Upute za uporabu korak po korak').
English: Benlysta should not be infused concomitantly in the same intravenous line with other agents.
Croatian: Benlysta se ne smije primjenjivati istovremeno istom intravenskom linijom s drugim lijekovima.
English: The reconstituted solution, if not used immediately, should be protected from direct sunlight and stored refrigerated at 2°C to 8°C.
Croatian: Rekonstituiranu otopinu, koja se ne koristi odmah, treba zaštititi od direktne sunčeve svjetlosti, te čuvati u hladnjaku na 2°C - 8°C.
English: • Do not warm the pen in any other way.
Croatian: • Nemojte zagrijavati brizgalicu ni na koji drugi način.
English: Based on simulations with population PK parameters the steady-state average belimumab concentrations for 200 mg subcutaneous every week were similar to 10 mg/kg intravenous every 4 weeks.
Croatian: Prema simulacijama na temelju populacijskih farmakokinetičkih parametara, prosječne koncentracije belimumaba u stanju dinamičke ravnoteže uz supkutanu primjenu u dozi od 200 mg jedanput tjedno bile su slične onima uz intravensku primjenu u dozi od 10 mg/kg svaka 4 tjedna.
English: Tell your doctor if you have a history of these conditions.
Croatian: Recite svom liječniku ako ste imali neko od navedenih stanja.
English: Benlysta significantly reduced circulating overall, transitional, naïve, and SLE B cells, as well as plasma cells at Week 52.
Croatian: Benlysta je do 52. tjedna značajno snizila razine cirkulirajućih ukupnih, prijelaznih, naivnih i SLE B limfocita, kao i plazma stanica.
English: Benlysta should be infused over a 1-hour period.
Croatian: Benlysta se treba infundirati tijekom sat vremena.
English: Inspect the injection site
Croatian: Pregledajte mjesto injiciranja
English: After you have been trained on how to use the pen, your doctor or nurse may decide that you can give yourself the injection, or your caregiver can give it to you.
Croatian: Nakon što prođete obuku o tome kako koristiti brizgalicu, liječnik ili medicinska sestra možda će odlučiti da si injekcije možete davati sami ili da Vam ih može davati Vaš njegovatelj.
English: • a history of major organ transplant or hematopoietic stem cell /marrow transplant or renal transplant.
Croatian: • anamneze transplantacije vitalnih organa ili transplantacije hematopoetskih matičnih stanica/ koštane srži ili transplantacije bubrega.
English: For patients whose body weight is less than or equal to 40 kg, infusion bags with 100 ml of these diluents may be considered providing that the resulting belimumab concentration in the infusion bag does not exceed 4 mg/ml.
Croatian: Za bolesnike tjelesne težine 40 kg ili manje može se razmotriti uporaba infuzijskih vrećica koje sadrže 100 ml navedenih sredstava za razrjeđivanje, pod uvjetom da konačna koncentracija belimumaba u infuzijskoj vrećici ne bude veća od 4 mg/ml.
English: Belimumab is a human IgG1λ monoclonal antibody specific for soluble human B Lymphocyte Stimulator protein (BLyS, also referred to as BAFF and TNFSF13B).
Croatian: Belimumab je humano, IgG1λ monoklonsko protutijelo specifično za topivi humani proteinstimulator B limfocita (BlyS, također poznat kao BAFF i TNFSF13B).
English: The adverse reaction profile in paediatric patients is based on 52-week safety data from a placebo-controlled study in which 53 patients (6 to 17 years of age) with SLE received Benlysta (10 mg/kg intravenously on Days 0, 14, 28, and then every 28 days, on a background of concomitant treatments).
Croatian: Profil nuspojava u pedijatrijskih bolesnika temelji se na sigurnosnim podacima prikupljenima tijekom 52 tjedna u placebom kontroliranom ispitivanju u kojem su 53 bolesnika sa SLE-om (u dobi od 6 do 17 godina) primala lijek Benlysta (10 mg/kg intravenski 0., 14. i 28. dana, a zatim svakih 28 dana, uz istodobno primijenjenu osnovnu terapiju).
English: Flares in SLE were defined by the modified SELENA SLEDAI SLE Flare Index.
Croatian: Egzacerbacije SLE-a bile su definirane prema modificiranom SELENA SLEDAI SLE indeksu egzacerbacija (SELENA SLEDAI SLE Flare Index).
English: It is likely that Benlysta can pass into breast milk.
Croatian: Benlysta se vjerojatno izlučuje u majčino mlijeko.
English: * Among patients with baseline prednisone dose >7.5 mg/day
Croatian: * U bolesnika s početnom dozom prednizona >7,5 mg/dan
English: The pre-filled pen or pre-filled syringe should be used for subcutaneous injection only.
Croatian: Napunjena brizgalica ili napunjena štrcaljka smiju se upotrijebiti samo za supkutanu injekciju.
English: These adverse events of special interest include serious infections (including nonserious and serious opportunistic infections and PML, malignancies (including nonmelanoma skin cancer), serious infusion and hypersensitivity reactions, and serious psychiatric events including mood disorders, anxiety and suicide.
Croatian: Te nuspojave od posebnog interesa uključuju ozbiljne infekcije (uključujući neozbiljne i ozbiljne oportunističke infekcije i PML, maligne bolesti (uključujući karcinom kože koji nije melanom) i ozbiljne psihijatrijske događaje uključujući poremećaje raspoloženja, anksioznost i samoubojstvo.
English: Infections leading to discontinuation of treatment occurred in 0.7% of patients receiving Benlysta and 1.5% of patients receiving placebo.
Croatian: Infekcije koje su dovele do prekida liječenja javile su se u 0,7% bolesnika koji su primali lijek Benlysta i 1,5% bolesnika koji su primali placebo.
English: BLyS levels are elevated in patients with SLE and other autoimmune diseases.
Croatian: Razine BLyS proteina povišene su u bolesnika sa SLE-om i ostalim autoimunim bolestima.
English: Table 4 - PRINTO/ACR response rate at Week 52
Croatian: Tablica 4: Stopa odgovora prema PRINTO/ACR kriterijima u 52. tjednu
English: In case administration of Benlysta to elderly patients is deemed necessary, dose adjustment is not required (see section 5.2).
Croatian: U slučaju da se primjena lijeka Benlysta u starijih bolesnika ocijeni neophodnom, prilagodba doze nije potrebna (vidjeti dio 5.2).
English: Prednisone reduction by ≥25% from baseline to ≤7.5 mg/day during weeks 40 through 52*
Croatian: Smanjenje prednizona ≥25% od početne vrijednosti, na ≤7,5 mg/dan, tijekom 40. do 52. tjedna* (%)
English: The package leaflet should be available to the patient.
Croatian: Bolesniku treba biti dostupna uputa o lijeku.
English: These may affect more than 1 in 10 people:
Croatian: Mogu se javiti u više od 1 na 10 osoba:
English: Reproductive studies have been performed in pregnant cynomolgus monkeys receiving belimumab 150 mg/kg by intravenous infusion (approximately 9 times the anticipated maximum human clinical exposure) every 2 weeks for up to 21 weeks, and belimumab treatment was not associated with direct or indirect harmful effects with respect to maternal toxicity, developmental toxicity, or teratogenicity.
Croatian: 150 mg/kg putem intravenske infuzije (otprilike 9 puta više od predviđene maksimalne kliničke izloženosti za ljude) svaka 2 tjedna tijekom najviše 21 tjedna, te liječenje belimumabom nije bilo povezano s posrednim ili neposrednim štetnim učincima vezanima uz reproduktivnu toksičnost, razvojnu toksičnost ili teratogenost.
English: • diarrhoea, vomiting
Croatian: • proljev, povraćanje
English: Physicians should advise patients (and caregivers where appropriate) to contact their health care provider about new or worsening psychiatric symptoms.
Croatian: Liječnici trebaju uputiti bolesnike (a po potrebi i njegovatelje) da se u slučaju pojave novih ili pogoršanja postojećih psihijatrijskih simptoma obrate svom liječniku.
English: Table 1: Response rate at week 52
Croatian: Tablica 1: Stopa odgovora u 52. tjednu
English: The intravenous pharmacokinetic parameters quoted below are based on population parameter estimates for the 563 patients who received Benlysta 10 mg/kg in the two Phase III studies.
Croatian: Niže navedeni farmakokinetički pokazatelji za intravensku formulaciju temelje se na procjenama populacijskih pokazatelja za 563 bolesnika koju su primali 10 mg/kg lijeka Benlysta u dva ispitivanja faze III.
English: Body
Croatian: Tijelo
English: Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk.
Croatian: Bolesnici s anamnezom alergije na različite lijekove ili značajnom preosjetljivošću mogu biti pod povećanim rizikom.
English: It reduces the number of B cells in your blood by blocking the action of BLyS, a protein that helps B cells to live longer and is found in high levels in people with lupus.
Croatian: Smanjuje broj B limfocita u krvi blokirajući djelovanje BLyS-a, proteina koji omogućuje B limfocitima da žive duže.
English: The subcutaneous pharmacokinetic parameters below are based on population parameter estimates from 661 subjects, comprised of 554 SLE patients and 107 healthy subjects, who received Benlysta subcutaneously.
Croatian: Niže navedeni farmakokinetički pokazatelji za supkutanu formulaciju temelje se na procjenama populacijskih pokazatelja za 661 ispitanika (554 bolesnika sa SLE-om i 107 zdravih dobrovoljaca) koji je lijek Benlysta primao supkutano.
English: To improve the traceability of this medicine, you and your healthcare provider should record the Benlysta lot number.
Croatian: Kako bi se poboljšala sljedivost ovog lijeka, Vi i Vaš liječnik trebate zabilježiti broj serije lijeka
English: Within the overall SLE intravenous study population, age did not affect belimumab exposure in the population pharmacokinetic analysis.
Croatian: U ukupnoj populaciji ispitanika s SLE-om u ispitivanju intravenske primjene lijeka, dob nije utjecala na izloženost belimumabu u farmakokinetičkoj analizi populacije.
English: The stream of water for injections should be directed toward the side of the vial to minimize foaming.
Croatian: Mlaz vode za injekcije treba biti usmjeren prema stijenci bočice kako bi se smanjilo pjenjenje.
English: Immunisation
Croatian: Imunizacija
English: Serious depression was reported in 0.3% (7/2002) of patients receiving Benlysta and <0.1% (1/2001) of patients receiving placebo.
Croatian: Ozbiljna depresija prijavljena je u 0,3% (7/2002) bolesnika koji su primali lijek Benlysta te < 0,1% (1/2001) onih koji su primali placebo.
English: Warnings
Croatian: Upozorenja
English: These are common side effects (may affect up to 1 in 10 people).
Croatian: Radi se o čestim nuspojavama (koje se mogu javiti u do 1 na 10 osoba).
English: Patients had active SLE disease, defined as a SELENA-SLEDAI (SELENA=Safety of Estrogens in Systemic Lupus Erythematosus National Assessment; SLEDAI=Systemic Lupus Erythematosus Disease Activity Index) score ≥6 and positive anti-nuclear antibody (ANA) test results (ANA titre ≥1:80 and/or a positive anti-dsDNA [≥30 units/ml]) at screening.
Croatian: Bolesnici su imali aktivnu bolest, definiranu indeksom SELENA-SLEDAI (SELENA = Safety of Estrogens in Systemic Lupus Erythematosus National Assessment; SLEDAI = Systemic Lupus Erythematosus Disease Activity Index) ≥6 i pozitivan test na antinuklearna protutijela (ANA) - (ANA titar ≥1:80 i/ili pozitivna anti-dsDNK [≥30 jedinica/ml]) na probiru.
English: Belimumab blocks the binding of soluble BLyS, a B cell survival factor, to its receptors on B cells.
Croatian: Belimumab blokira vezanje topivog BLyS, koji je faktor za preživljavanje B limfocita, za njegove receptore na B limfocitima.
English: SLE Responder Index (%)
Croatian: Indeks odgovora SLE-a (%)
English: • Ask your doctor or pharmacist for instructions on how to properly dispose of a used syringe or container of used syringes.
Croatian: • Pitajte svog liječnika ili ljekarnika kako pravilno zbrinuti upotrijebljenu štrcaljku ili spremnik s upotrijebljenim štrcaljkama.
English: Your doctor will discuss with you whether you should stop treatment with Benlysta while you are breast-feeding, or if you should stop breast-feeding.
Croatian: Liječnik će razgovarati s Vama o tome trebate li prekinuti liječenje lijekom Benlysta tijekom dojenja, ili trebate prekinuti dojenje.
English: • Do not remove the ring cap during this step.
Croatian: • Nemojte skidati zatvarač s prstenom u ovom koraku.
English: Infections occurring in at least 3% of patients receiving Benlysta and at least 1% more frequently than patients receiving placebo were viral upper respiratory tract infection, bronchitis, and urinary tract infection bacterial.
Croatian: Infekcije koje su se javile u najmanje 3% bolesnika koji su primali lijek Benlysta te barem 1% češće nego u bolesnika koji su primali placebo bile su virusna infekcija gornjih dišnih putova, bronhitis i bakterijska infekcija mokraćnih putova.
English: Physicians should assess the risk of depression and suicide considering the patient's medical history and current psychiatric status before treatment with Benlysta and continue to monitor patients during treatment.
Croatian: Prije početka liječenja lijekom Benlysta liječnici trebaju ocijeniti rizik od depresije i samoubojstva, uzimajući u obzir bolesnikovu anamnezu i trenutačan psihijatrijski status, te trebaju nastaviti nadzirati bolesnike tijekom liječenja.
English: • Do not shake.
Croatian: • Nemojte je tresti.
English: To improve the traceability of this medicine, your healthcare provider should record the Benlysta lot number in your patient file.
Croatian: Kako bi se poboljšala sljedivost ovog lijeka, liječnik treba zabilježiti broj serije lijeka Benlysta u Vaš bolesnički karton.
English: Purple indicator
Croatian: Ljubičasti indikator
English: Anti-dsDNA positive AND low complement
Croatian: Pozitivna anti-dsDNK I sniženi komplement
English: Please refer to the Summary of Product Characteristics for Benlysta powder for concentrate for solution for infusion (section 4.4).
Croatian: Vidjeti sažetak opisa svojstava lijeka za Benlysta prašak za koncentrat za otopinu za infuziju (dio 4.4).
English: Instructions for using the pre-filled syringe are given at the end of this leaflet.
Croatian: Upute za uporabu napunjene brizgalice navedene su na kraju ove upute.
English: • Do not remove the needle cap during this step.
Croatian: • Nemojte skidati zatvarač igle u ovom koraku.
English: Gastroenteritis viral, pharyngitis, nasopharyngitis, viral upper respiratory tract infection
Croatian: infekcija mokraćnih putova često virusni gastroenteritis, faringitis, nazofaringitis, virusna infekcija gornjih dišnih putova
English: Final concentration
Croatian: Volumen otapala Konačna koncentracija
English: The reduction in systemic clearance estimated by population PK modelling for patients at the midpoints of the renal impairment categories relative to patients with median creatinine clearance in the PK population (79.9 ml/min) were 1.4% for mild (75 ml/min), 11.7% for moderate (45 ml/min) and 24.0% for severe (22.5 ml/min) renal impairment.
Croatian: Smanjenje sistemskog klirensa procijenjeno putem populacijskog farmakokinetičkog modeliranja za bolesnike sa središnjim vrijednostima kategorija oštećenja bubrežne funkcije u odnosu na bolesnike s medijanom klirensa kreatinina u farmakokinetičkoj populaciji (79,9 ml/min) bilo je 1,4% za blago (75 ml/min), 11,7% za umjereno (45 ml/min) i 24,0% za teško (22,5 ml/min) oštećenje funkcije bubrega.
English: Benlysta in pre-filled pen or pre-filled syringe is administered by subcutaneous injection.
Croatian: Benlysta u napunjenoj brizgalici ili napunjenoj štrcaljki primjenjuje se supkutanom injekcijom.
English: None of these gastrointestinal events in obese patients were serious.
Croatian: Nijedna od ovih probavnih tegoba u pretilih bolesnika nije bila ozbiljna.
English: In the event of a severe reaction, Benlysta administration must be interrupted and appropriate medical therapy administered (see section 4.2).
Croatian: U slučaju teške reakcije, primjena lijeka Benlysta mora se prekinuti, te primijeniti odgovarajuće liječenje (vidjeti dio 4.2).
English: • Do not use if the solution looks cloudy, discoloured or has particles.
Croatian: • Nemojte primijeniti otopinu ako izgleda mutno, ako je promijenila boju ili ako sadrži čestice.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Croatian: Lijek se izdaje na ograničeni recept (Vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2)
English: SLE patients transitioning from 10 mg/kg intravenously every 4 weeks to 200 mg subcutaneously weekly using a 1 to 4 week switching interval had pre-dose belimumab serum concentrations at their first subcutaneous dose close to their eventual subcutaneous steady-state trough concentration (see section 4.2).
Croatian: U bolesnika sa SLE-om koji su prešli s liječenja dozom od 10 mg/kg intravenski svaka 4 tjedna na liječenje dozom od 200 mg supkutano jedanput tjedno uz prijelazni interval od 1 do 4 tjedna, serumske koncentracije belimumaba prije primjene prve supkutane doze bile su približno jednake najnižoj koncentraciji u stanju dinamičke ravnoteže koju su ti bolesnici naposljetku postigli uz supkutanu primjenu (vidjeti dio 4.2).
English: Patients treated with Benlysta should be made aware of the potential risk of severe or life-threatening hypersensitivity and the potential for delayed onset or recurrence of symptoms.
Croatian: Bolesnici liječeni lijekom Benlysta bi trebali biti upoznati s mogućim rizikom nastanka teških ili po život opasnih reakcija preosjetljivosti i moguće odgođene ili ponovne pojave simptoma.
English: Benlysta can have side effects which may make you less able to drive or use machines.
Croatian: Benlysta može izazvati nuspojave koje mogu smanjiti sposobnost upravljanja vozilima i rada sa strojevima.
English: *‘Hypersensitivity reactions' covers a group of terms, including anaphylaxis, and can manifest as a range of symptoms including hypotension, angioedema, urticaria or other rash, pruritus, and dyspnoea.
Croatian: *'Reakcije preosjetljivosti' obuhvaćaju skupinu termina, uključujući anafilaksiju, te se mogu manifestirati kao niz simptoma koji uključuju hipotenziju, angioedem, urtikariju ili drugu vrstu osipa,
English: • Do not inject in areas where the skin is tender, bruised, red or hard.
Croatian: Lijek se nikad ne smije injicirati u područja gdje je koža osjetljiva na dodir, prekrivena modricama, crvena ili tvrda.
English: BLISS-76 and BLISS-52 pooled data
Croatian: BLISS-76 i BLISS-52 skupni podaci
English: In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati.
English: Malignancies and lymphoproliferative disorders
Croatian: Maligne bolesti i limfoproliferativni poremećaji
English: Each vial contains 400 mg belimumab (80 mg/ml after reconstitution)
Croatian: Jedna bočica sadrži 400 mg belimumaba (80 mg/ml nakon rekonstitucije)
English: Store in the original package in order to protect from light.
Croatian: Čuvati u originalnom pakiranju radi zaštitite od svjetlosti.
English: Caution should be exercised when considering Benlysta therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop malignancy.
Croatian: Potreban je oprez pri razmatranju terapije lijekom Benlysta u bolesnika s anamnezom maligne bolesti ili pri procjeni nastavka liječenja u bolesnika koji su razvili maligni tumor.
English: Patients with a history of multiple drug allergies or significant hypersensitivity reactions may be at increased risk.
Croatian: Bolesnici koji u anamnezi imaju alergiju na više lijekova ili značajne reakcije preosjetljivosti mogu biti pod povećanim rizikom.
English: Among persistent-positive subjects in the Phase III studies, 1/10 (10%), 2/27 (7%) and 1/4 (25%) subjects in the placebo, 1 mg/kg and 10 mg/kg groups, respectively, experienced infusion reactions on a dosing day; these infusion reactions were all non-serious and mild to moderate in severity.
Croatian: Među trajno pozitivnim ispitanicima u ispitivanjima faze III, 1/10 (10%) ispitanika u placebo skupini, 2/27 (7%) ispitanika u skupini koja je primala dozu od 1 mg/kg, te 1/4 (25%) ispitanika koji su primali dozu od 10 mg/kg, imalo je infuzijske reakcije na dan primjene lijeka; nijedna od tih infuzijskih reakcija nije bila ozbiljna i bile su blage do umjerene težine.
English: There were too few patients ≥65 years of age or black patients enrolled in the controlled clinical trials with subcutaneous Benlysta to draw meaningful conclusions about the effects of age or race on clinical outcomes.
Croatian: Premalo je bolesnika u dobi od ≥ 65 godina ili bolesnika crne rase sudjelovalo u kontroliranim kliničkim ispitivanjima formulacije lijeka Benlysta za supkutanu primjenu da bi se donijeli značajni zaključci o učincima dobi ili rase na kliničke ishode.
English: The rates of infusion reactions among persistent-positive subjects were comparable to the rates for ADA negative patients of 75/552 (14%), 78/523 (15%), and 83/559 (15%) in the placebo, 1 mg/kg and 10 mg/kg groups, respectively.
Croatian: Stope infuzijskih reakcija među trajno pozitivnim ispitanicima bile su usporedive sa stopama ADA-negativnih ispitanika u 75/552 (14%) bolesnika u placebo skupini, 78/523 (15%) u skupini koja je primala 1 mg/kg, te 83/559 (15%) u skupini koja je primala dozu od 10 mg/kg.
English: • Remove one sealed tray containing a pre-filled syringe from the refrigerator.
Croatian: • Izvadite jedan zatvoreni podložak s napunjenom štrcaljkom iz hladnjaka.
English: Following subcutaneous administration, belimumab had a terminal half-life of 18.3 days.
Croatian: Terminalni poluvijek belimumaba nakon supkutane primjene iznosio je 18,3 dana.
English: There are a limited amount of data from the use of Benlysta in pregnant women.
Croatian: Podaci o primjeni lijeka Benlysta u trudnica su ograničeni.
English: No detrimental effects on such activities are predicted from the pharmacology of belimumab.
Croatian: Farmakologija belimumaba ne predviđa nikakve štetne učinke pri takvim aktivnostima.
English: In intravenous clinical studies, serious infusion and hypersensitivity reactions included anaphylactic reaction, bradycardia, hypotension, angioedema, and dyspnoea.
Croatian: U kliničkim ispitivanjima intravenske primjene ozbiljne infuzijske reakcije i reakcije preosjetljivosti uključivale su anafilaktičku reakciju, bradikardiju, hipotenziju, angioedem i dispneju.
English: Patients who had severe active lupus nephritis, severe active CNS lupus, primary immunodeficiency, IgA deficiency or acute or chronic infections requiring management were excluded from the study.
Croatian: U ispitivanju nisu mogli sudjelovati bolesnici koji su imali težak aktivan lupus nefritis, težak aktivan lupus središnjeg živčanog sustava, primarnu imunodeficijenciju, nedostatak IgA ili akutne ili kronične infekcije koje su zahtijevale liječenje.
English: Responders (%)
Croatian: Bolesnici s odgovorom (%)