FrancophonIA/ELRC3.0 huggingface dataset:
English: Allow 10 to 15 minutes for the vial to warm to room temperature (15°C to 25°C).
Croatian: Ostavite bočicu 10-15 minuta da se zagrije na sobnu temperaturu (15°C - 25°C).
English: SRI response rate (excluding complement and anti-dsDNA changes) at week 52 (%)
Croatian: Stopa SRI odgovora (izuzevši promjene u razini komplementa i anti-dsDNK) u 52. tjednu (%)
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential must use effective contraception during Benlysta treatment and for at least 4 months after the last treatment.
Croatian: Žene reproduktivne dobi/Kontracepcija u muškaraca i žena Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja lijekom Benlysta i još barem 4 mjeseca nakon zadnjeg liječenja.
English: There is an association between plasma BLyS levels and SLE disease activity.
Croatian: Postoji povezanost između razina BLyS u plazmi i aktivnosti SLE-a.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake 'Rok valjanosti' ili kratice 'EXP'.
English: Patients were on a stable SLE treatment regimen (standard of care) and had similar inclusion criteria as the adult studies.
Croatian: Bolesnici su primali stabilnu terapiju za SLE (standardno liječenje), a uključni kriteriji bili su slični onima u ispitivanjima provedenima u odraslih.
English: • loss of vision.
Croatian: • gubitak vida
English: Patients had active SLE disease, defined as a SELENA-SLEDAI score ≥6 and positive autoantibodies at screening as described in the adult trials.
Croatian: Bolesnici su imali aktivan SLE, koji se definirao kao SELENA-SLEDAI rezultat ≥ 6 i pozitivan nalaz testa na autoprotutijela pri probiru, kako je opisano u ispitivanjima provedenima u odraslih.
English: The safety registry will evaluate the incidence of all-cause mortality and adverse events of special interest in patients with systemic lupus erythematosus.
Croatian: Registar sigurnosti će procjenjivati incidenciju smrti svih uzroka i nuspojave od posebnog interesa u bolesnika sa sistemskim eritematoznim lupusom.
English: B cell numbers recovered after the cessation of belimumab treatment by about 1 year post-partum in adult monkeys and by 3 months of life in infant monkeys; IgM levels in infants exposed to belimumab in utero recovered by 6 months of age.
Croatian: limfocita obnovio se nakon prestanka liječenja belimumabom nakon otprilike jedne godine poslije okota u odraslih majmuna, te do 3. mjeseca života u mladunčadi majmuna; razine IgM-a u mladunčadi pri izloženosti belimumabu in utero oporavile su se do 6. mjeseca života.
English: There were no serious depression-related events or suicides reported in either group.
Croatian: Ni u jednoj skupini nije prijavljen nijedan ozbiljan događaj povezan s depresijom te nijedan slučaj samoubojstva.
English: There were too few patients ≥65 years of age enrolled in the controlled clinical trials to draw meaningful conclusions about the effects of age on clinical outcomes.
Croatian: Premalo je bolesnika u dobi od ≥ 65 godina sudjelovalo u kontroliranim kliničkim ispitivanjima da bi se donijeli značajni zaključci o učincima dobi na kliničke ishode.
English: The total time from reconstitution of Benlysta to completion of infusion should not exceed 8 hours.
Croatian: Ukupno vrijeme proteklo od rekonstitucije lijeka Benlysta do završetka infuzije ne bi smjelo biti dulje od 8 sati.
English: A patient may self-inject or the patient caregiver may administer Benlysta after the healthcare professional determines that it is appropriate.
Croatian: Bolesnik može sam injicirati lijek Benlysta ili mu ga može primijeniti njegovatelj nakon što zdravstveni radnik utvrdi da je to prikladno.
English: 3) How to dilute the solution for infusion
Croatian: 3) Kako razrijediti otopinu za infuziju
English: The maximum serum concentration (Cmax) of belimumab at steady state was 108 µg/ml.
Croatian: Maksimalna serumska koncentracija (Cmax) belimumaba u stanju dinamičke ravnoteže iznosila je 108 µg/ml.
English: • If needed, press a cotton ball or gauze pad on the injection site.
Croatian: • Ako je potrebno, pritisnite pamučnu vatu ili gazu na mjesto injiciranja.
English: Physicians should exercise caution when considering the use of Benlysta in patients with severe or chronic infections or a history of recurrent infection.
Croatian: Liječnici trebaju biti oprezni kad razmatraju primjenu lijeka Benlysta u bolesnika s teškim ili kroničnim infekcijama ili anamnezom rekurentnih infekcija.
English: Treatment-related findings were limited to the expected reversible reduction of B cells in both dams and infants and reversible reduction of IgM in infant monkeys.
Croatian: Nalazi povezani s liječenjem bili su ograničeni na očekivano reverzibilno smanjenje broja B limfocita u ženskog roditelja i u potomka, te reverzibilno smanjenje IgM-a u mladunčadi majmuna.
English: Tell your doctor or nurse immediately, or go to the Emergency department of your nearest hospital, if you get any of the following symptoms of an allergic or infusion reaction:
Croatian: Odmah obavijestite svog liječnika ili medicinsku sestru ili otiđite u hitnu službu najbliže bolnice ako se javi bilo koji od sljedećih simptoma alergijske ili infuzijske reakcije:
English: It is recommended that a 21-25 gauge needle be used when piercing the vial stopper for reconstitution and dilution.
Croatian: Preporučuje se upotreba igle veličine 21-25 G za bušenje čepa na bočici kod rekonstitucije i razrjeđivanja.
English: This study was conducted in the US, South America, Europe and Asia.
Croatian: Ispitivanje se provodilo u SAD-u, Južnoj Americi, Europi i Aziji.
English: Transition from intravenous to subcutaneous administration
Croatian: Prelazak s intravenske na supkutanu primjenu
English: • Do not use if left out at room temperature for more than 12 hours.
Croatian: • Ne upotrijebiti ako je štrcaljka bila na sobnoj temperaturi dulje od 12 sati.
English: • Do not share your Benlysta pre-filled syringe with another person.
Croatian: • Nemojte dijeliti svoju Benlysta napunjenu štrcaljku s drugom osobom.
English: There were two suicides in Benlysta-treated patients (including one receiving 1 mg/kg Benlysta).
Croatian: U bolesnika liječenih lijekom Benlysta zabilježena su dva slučaja samoubojstva (uključujući jedan u bolesnika koji je primao lijek Benlysta u dozi od 1 mg/kg).
English: The safety of belimumab in patients with SLE has been evaluated in 3 pre-registration, placebo-controlled intravenous studies, 1 placebo-controlled subcutaneous study, and one post-marketing, placebo-controlled intravenous study.
Croatian: Sigurnost belimumaba u bolesnika sa SLE-om ocjenjivana je u 3 predregistracijska, placebom kontrolirana ispitivanja intravenske primjene, 1 placebom kontroliranom ispitivanju supkutane primjene i 1 placebom kontroliranom ispitivanju intravenske primjene provedenom nakon stavljanja lijeka u promet.
English: Belimumab was distributed to tissues with steady-state volume (Vss) of distribution of approximately 5 litres.
Croatian: Belimumab se raspodjeljuje u tkiva, uz volumen distribucije u stanju dinamičke ravnoteže (Vss) od približno 5 litara.
English: These adverse events of special interest include serious infections (including opportunistic infections and PML), selected serious psychiatric events, and malignancies (including non-melanoma skin cancer).
Croatian: Te nuspojave od posebnog interesa uključuju teške infekcije (oportunističke infekcije i PML), odabrane ozbiljne psihijatrijske događaje i maligne bolesti (uključujući karcinom kože koji nije melanom).
English: The risk of hypersensitivity reactions is greatest with the first two doses; however the risk should be considered for every administration.
Croatian: Rizik od razvoja reakcija preosjetljivosti najveći je kod prve dvije doze; međutim taj rizik treba uzeti u obzir prilikom svake primjene.
English: • Use an effective method of contraception while you are being treated with Benlysta and for at least 4 months after the last dose.
Croatian: • Koristite učinkovitu metodu kontracepcije dok se liječite lijekom Benlysta i još najmanje
English: Allow the vial to sit at room temperature (15°C to 25°C) during reconstitution, gently swirling the vial for 60 seconds every 5 minutes until the powder is dissolved.
Croatian: Ostavite bočicu da stoji na sobnoj temperaturi (15°C - 25°C) tijekom rekonstitucije, nježno vrteći bočicu 60 sekundi, svakih 5 minuta, dok se prašak ne otopi.
English: Psychiatric disorders also includes data from a post-marketing study.
Croatian: Podaci o psihijatrijskim poremećajima uključuju i podatke prikupljene u ispitivanju provedenom nakon stavljanja lijeka u promet.
English: • cough, breathing problems
Croatian: • kašalj, problemi s disanjem
English: The mechanism of action of belimumab could increase the risk for the development of infections in adults and children with lupus, including opportunistic infections, and younger children may be at increased risk.
Croatian: Infekcije Mehanizam djelovanja belimumaba mogao bi povećati rizik od razvoja infekcija u odraslih i djece s lupusom, uključujući oportunističke infekcije, a rizik bi mogao biti povećan u mlađe djece.
English: The active ingredient is belimumab.
Croatian: Djelatna tvar je belimumab.
English: Benlysta infusions should be administered by a qualified healthcare professional trained to give infusion therapy.
Croatian: Infuzije lijeka Benlysta treba primjenjivati kvalificirani zdravstveni radnik obučen za davanje infuzijske terapije.
English: No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of Benlysta with other agents.
Croatian: Nisu provedena ispitivanja o fizičkoj ili biokemijskoj kompatibilnosti u svrhu procjene istovremene primjene lijeka Benlysta s drugim lijekovima.
English: Anti-dsDNA positive AND low complement Placebo
Croatian: Pozitivna anti-dsDNK I sniženi komplement Placebo
English: Pregnancy and breast-feeding Contraception in women of childbearing potential
Croatian: Trudnoća i dojenje Kontracepcija u žena reproduktivne dobi
English: (Figure 1)
Croatian: (Slika 1).
English: • The pre-filled syringe should be used only once and then discarded.
Croatian: • Napunjena štrcaljka smije se upotrijebiti samo jednom i zatim baciti.
English: After 7 and a half years of treatment (including the 72-week parent study), a substantial and sustained decrease in various B cell subsets was observed leading to 87% median reduction in naïve B cells, 67% in memory B cells, 99% in activated B cells, and 92% median reduction in plasma cells after more than 7 years of treatment.
Croatian: Nakon 7 i pol godina liječenja (uključujući 72 tjedna primarnog ispitivanja), zamijećeno je značajno i postojano smanjenje različitih podskupina B limfocita koje je dovelo do sniženja broja naivnih B limfocita s medijanom od 87%, memorijskih B limfocita od 67%, aktiviranih B limfocita od 99%, te sniženjem u broju plazma stanica s medijanom od 92% nakon više od 7 godina liječenja.
English: ≥1/100 to <1/10
Croatian: ≥ 1/100 i <1/10
English: The risk of hypersensitivity reactions is greatest with the first two infusions; however the risk should be considered for every infusion administered.
Croatian: Rizik od razvoja reakcija preosjetljivosti je najveći kod prve dvije infuzije; međutim taj rizik treba uzeti u obzir prilikom svake primjene infuzije.
English: Proportion of patients with at least 30% improvement in 3 of 5 components* and no more than one of the remaining worsening more than 30%
Croatian: Udio bolesnika koji su ostvarili poboljšanje za najmanje 30% u 3 od 5 komponenti*, pri čemu je u najviše jednoj od preostalih komponenti zabilježeno pogoršanje za više od 30%
English: After you have been trained on how to use the syringe, 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 štrcaljku, liječnik ili medicinska sestra možda će odlučiti da si injekcije možete davati sami ili da Vam ih može davati Vaš njegovatelj.
English: The study will evaluate over a minimum of 1 year the incidence of all-cause mortality and adverse events of special interest in patients with systemic lupus erythematosus.
Croatian: Ispitivanje će kroz minimalno 1 godinu procjenjivati incidenciju smrti svih uzroka i nuspojava od posebnog interesa u bolesnika sa sistemskim eritematoznim lupusom.
English: Proportion of patients with at least 50% improvement in any 2 of 5 components* and no more than one of the remaining worsening by more than 30%
Croatian: Udio bolesnika koji su ostvarili poboljšanje za najmanje 50% u bilo koje 2 od 5 komponenti*, pri čemu je u najviše jednoj od preostalih komponenti zabilježeno pogoršanje za više od 30%
English: Benlysta is for use under the skin only (subcutaneous).
Croatian: Benlysta je namijenjena isključivo za primjenu pod kožu (supkutanu primjenu).
English: The differences between the treatment groups were apparent by Week 16 and sustained through Week 52 (Figure 1).
Croatian: Razlike između liječenih skupina postale su primjetne do 16. tjedna, a održale su se do 52. tjedna
English: Immunomodulatory medicinal products, including Benlysta, may increase the risk of malignancy.
Croatian: Imunomodulatorni lijekovi, uključujući lijek Benlysta, mogu povećati rizik od nastanka malignih tumora.
English: Complete the injection
Croatian: Završite injekciju
English: 5 How to store Benlysta Contents of the pack and other information
Croatian: Kako čuvati lijek Benlysta Sadržaj pakiranja i druge informacije
English: If patients wish to change their weekly dosing day, a new dose can be given on the newly preferred day of the week.
Croatian: Ako bolesnik želi promijeniti dan u tjednu kada primjenjuje lijek, novu dozu može primijeniti onaj dan u tjednu kada želi uzimati lijek.
English: If a mechanical reconstitution device is used to reconstitute Benlysta it should not exceed 500 rpm and the vial should be swirled for no longer than 30 minutes.
Croatian: Ako koristite mehanički uređaj za rekonstituciju lijeka Benlysta, brzina ne smije biti veća od 500 okretaja/min, a bočica se ne smije vrtjeti duže od 30 minuta.
English: Intravenous and subcutaneous administration to monkeys resulted in the expected reduction in the number of peripheral and lymphoid tissue B cell counts with no associated toxicological findings.
Croatian: Intravenska i supkutana primjena u majmuna rezultirala je očekivanim smanjenjem broja B limfocita u perifernim i limfatičkim tkivima bez povezanih toksikoloških pojava.
English: Of these patients, 64.5% had SELENA SLEDAI scores ≥ 10 at baseline.
Croatian: Od ovih bolesnika, 64,5% je ishodišno imalo SELENA
English: The formation of some CYP450 enzymes is suppressed by increased levels of certain cytokines during chronic inflammation.
Croatian: Povišene razine određenih citokina tijekom kronične upale potiskuju stvaranje nekih CYP450 enzima.
English: The primary efficacy endpoint was a composite endpoint (SLE Responder Index) that defined response as meeting each of the following criteria at Week 52 compared with baseline:
Croatian: Kao primarna mjera ishoda djelotvornosti korištena je kompozitna mjera ishoda (indeks odgovora SLE-a - SLE Responder Index [SRI]) koja je definirala odgovor na terapiju kao postizanje svakog od sljedećih navedenih kriterija, nakon 52 tjedna u usporedbi s početnom procjenom:
English: Body weight/Body mass index (BMI)
Croatian: Tjelesna težina/Indeks tjelesne mase (ITM):
English: The overall incidence of serious suicidal ideation or behaviour or self-injury without suicidal intent was 0.7% (15/2002) in patients receiving Benlysta and 0.2% (5/2001) in the placebo group.
Croatian: Ukupna incidencija ozbiljnih suicidalnih misli ili ponašanja ili samoozljeđivanja bez suicidalne namjere iznosila je 0,7% (15/2002) u bolesnika koji su primali lijek Benlysta te 0,2% (5/2001) u skupini koja je primala placebo.
English: Patients who develop an infection while undergoing treatment with Benlysta should be monitored closely and careful consideration given to interrupting immunosuppressant therapy including belimumab until the infection is resolved.
Croatian: Bolesnici koji razviju infekciju za vrijeme liječenja lijekom Benlysta trebaju biti pod pomnim nadzorom te se treba pažljivo razmotriti prekid terapije imunosupresivima uključujući belimumab dok se infekcija ne riješi.
English: Univariate and multivariate analysis of the primary endpoint in pre-specified subgroups demonstrated that the greatest benefit was observed in patients with higher disease activity including patients with SELENA SLEDAI scores ≥ 10, or patients requiring steroids to control their disease, or patients with low complement levels.
Croatian: Jednovarijatna i multivarijatna analiza primarne mjere ishoda u prethodno specificiranim podskupinama pokazala je da je najveća korist uočena u bolesnika s višom aktivnošću bolesti, uključujući bolesnike sa SELENA SLEDAI rezultatima ≥10, bolesnike koji zahtijevaju steroide kako bi kontrolirali svoju bolest ili bolesnike s niskim razinama komplementa.
English: On initiation or discontinuation of belimumab, therapeutic monitoring should be considered for patients being treated with CYP substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g. warfarin).
Croatian: Potrebno je razmotriti terapijsko praćenje kada se liječenje belimumabom uvodi ili prekida u bolesnika koji se liječe supstratima CYP enzima uskog terapijskog indeksa, čija se doza individualno prilagođava (npr. varfarinom).
English: • Remove the needle cap by pulling it straight off. (Figure 6b)
Croatian: • Ravno povucite zatvarač igle i skinite ga. (Slika 6b)
English: The proportion of black patients achieving an SRI-S2K response was higher in patients receiving Benlysta but the difference was not statistically significant compared with placebo.
Croatian: Udio bolesnika crne rase koji su postigli odgovor prema SRI-S2K indeksu bio je veći među bolesnicima koji su primali lijek Benlysta, no razlika u odnosu na placebo nije bila statistički značajna.
English: • Do not rub the injection site.
Croatian: • Nemojte trljati mjesto injiciranja.
English: The B cell and IgG response to long term treatment with intravenous Benlysta was assessed in an uncontrolled extension study.
Croatian: Odgovor razina B limfocita i IgG-a na dugoročno liječenje intravenski primijenjenim lijekom Benlysta ocjenjivao se u nekontroliranom produžetku kliničkog ispitivanja.
English: However, in a small study evaluating the response to a 23-valent pneumococcal vaccine, overall immune responses to the different serotypes were similar in SLE patients receiving Benlysta compared with those receiving standard immunosuppressive treatment at the time of vaccination.
Croatian: Međutim u malom ispitivanju u kojem se ocjenjivao odgovor na 23-valentno pneumokokno cjepivo, ukupni imuni odgovori na različite serotipove bili su slični u bolesnika sa SLE-om koji su primali lijek
English: Benlysta 200 mg weekly
Croatian: Benlysta 200 mg tjedno
English: The relative contribution of BLyS levels to the pathophysiology of SLE is not fully understood.
Croatian: Relativni doprinos razina BLyS patofiziologiji samog SLE-a nije u potpunosti razjašnjen.
English: Inspection window
Croatian: Prozorčić za pregled
English: Benlysta subcutaneous injection must not be injected into a vein (intravenously).
Croatian: Benlysta za supkutanu primjenu ne smije se injicirati u venu (intravenski).
English: After reconstitution, the solution contains 80 mg belimumab per ml.
Croatian: Nakon rekonstitucije, otopina sadrži 80 mg belimumaba po ml.
English: Paediatric population: No pharmacokinetic data are available for subcutaneous administration of Benlysta in paediatric patients.
Croatian: Pedijatrijska populacija: Nema dostupnih farmakokinetičkih podataka o supkutanoj primjeni lijeka Benlysta u pedijatrijskih bolesnika.
English: The data presented in the table below reflect exposure to Benlysta administered (10 mg/kg intravenously over a 1-hour period on Days 0, 14, 28, and then every 28 days for up to 52 weeks) in 674 patients with SLE, including 472 exposed for at least 52 weeks, and 556 patients exposed to 200 mg Benlysta subcutaneously once weekly for up to 52 weeks.
Croatian: Podaci navedeni u sljedećoj tablici odnose se na izloženost lijeku Benlysta (10 mg/kg intravenski tijekom sat vremena 0., 14. i 28. dana, a nakon toga svakih 28 dana tijekom najviše 52 tjedna) u 674 bolesnika sa SLE-om, uključujući 472 bolesnika izložena barem 52 tjedna, te u 556 bolesnika liječenih lijekom Benlysta u supkutanoj dozi od 200 mg jedanput tjedno tijekom najviše 52 tjedna.
English: In the 5- to 11-year-old-group (n=13) the SELENA-SLEDAI score ranged from 4 to 13, and in 12- to 17-year-old-group (n=79) the SELENA-SLEDAI score ranged from 4 to 20.
Croatian: U skupini bolesnika u dobi od 5 do 11 godina (n=13) SELENA-SLEDAI rezultat kretao se u rasponu od 4 do 13 bodova, dok se u dobnoj skupini od 12 do 17 godina (n=79) kretao u rasponu od 4 do 20 bodova.
English: Then continue with your normal weekly schedule as usual or start a new weekly schedule starting from the day you inject the missed dose.
Croatian: Zatim nastavite s primjenom prema dotadašnjem rasporedu primjene jedanput tjedno ili započnite novi raspored primjene, počevši od dana injiciranja propuštene doze.
English: Memory cells increased initially and slowly declined toward baseline levels by Week 52.
Croatian: Razine memorijskih stanica na početku su porasle, a zatim su do 52. tjedna postupno padale prema početnim vrijednostima.
English: Once removed from the refrigerator, the syringe must be used within 12 hours or discarded.
Croatian: Nakon što štrcaljku izvadite iz hladnjaka, morate je upotrijebiti unutar 12 sati ili baciti.
English: Premedication including an antihistamine, with or without an antipyretic, may be administered before the infusion of Benlysta.
Croatian: Premedikacija, uključujući antihistaminik, s ili bez antipiretika, može se primijeniti prije infuzije lijeka Benlysta.
English: The efficacy and safety of Benlysta in the elderly has not been established.
Croatian: Djelotvornost i sigurnost lijeka Benlysta u starijih osoba nisu ustanovljene.
English: Belimumab does not bind B cells directly, but by binding BLyS, belimumab inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
Croatian: Belimumab se ne veže na B limfocite izravno, već vežući BLyS inhibira preživljavanje B limfocita, uključujući autoreaktivne B limfocite, te reducira diferencijaciju B limfocita u plazma stanice koje proizvode imunoglobuline.
English: Benlysta is administered intravenously by infusion, and must be reconstituted and diluted before administration.
Croatian: Način primjene Benlysta se primjenjuje intravenskom infuzijom, te mora biti rekonstituirana i razrijeđena prije primjene.
English: • Do not inject within 5 cm (2 inches) of the navel (belly button).
Croatian: • Nemojte injicirati unutar 5 cm od pupka.
English: Following intravenous administration of 10 mg/kg on Days 0, 14 and 28, and at 4-week intervals thereafter, belimumab exposures were similar between paediatric and adult SLE subjects.
Croatian: Nakon intravenske primjene doze od 10 mg/kg 0., 14. i 28. dana te u 4-tjednim intervalima nakon toga, izloženost belimumabu bila je slična u pedijatrijskih i odraslih ispitanika sa SLE-om.
English: (not included)
Croatian: (nije uključeno u pakiranje)
English: Your doctor may decide to give you medicines which help to reduce any infusion reactions before you are given Benlysta.
Croatian: Liječnik može odlučiti da Vam prije primjene lijeka Benlysta da lijekove koji pomažu smanjivanju infuzijskih reakcija.
English: Solution for injection in pre-filled pen (injection) Solution for injection in pre-filled syringe (injection)
Croatian: Otopina za injekciju u napunjenoj brizgalici (injekcija) Otopina za injekciju u napunjenoj štrcaljki (injekcija)