FrancophonIA/ELRC3.0 huggingface dataset:
English: A majority of Spinraza treated patients experienced stabilization or improvement in motor function, with the greatest benefit observed in those with earlier treatment initiation.
Croatian: Većina bolesnika liječena lijekom Spinraza postigla je stabilizaciju ili poboljšanje motoričke funkcije, a najveća je korist uočena u onih koji su s liječenjem počeli ranije.
English: For persistent elevated urinary protein, further evaluation should be considered.
Croatian: Kod trajno povišene razine proteina u mokraći potrebno je razmotriti potrebu za daljnjom procjenom.
English: There have been reports of communicating hydrocephalus not related to meningitis or bleeding in patients treated with nusinersen in the post-marketing setting.
Croatian: Zabilježeni su slučajevi neopstruktivnog hidrocefalusa koji nije bio povezan s meningitisom ili krvarenjem u bolesnika liječenih nusinersenom nakon stavljanja lijeka u promet.
English: Population PK analyses revealed no apparent correlation between hepatic and renal clinical chemistry markers and inter-subject variability.
Croatian: Populacijske farmakokinetičke analize nisu otkrile nikakvu vidljivu korelaciju između kliničko-kemijskih biljega funkcije jetre i bubrega i varijabilnosti između ispitanika.
English: The proportion of patients developing clinically manifested SMA was assessed amongst patients who reached the Day 700 visit at the interim analysis (n=16).
Croatian: Udio bolesnika koji su razvili klinički manifestnu SMA ocijenjen je među bolesnicima koji su u vrijeme interim analize imali obavljen pregled 700. dana (n=16).
English: The frequency of these reactions is not known as they have been reported from the post marketing setting.
Croatian: Učestalost tih nuspojava nije poznata jer su prijavljene nakon stavljanja lijeka u promet.
English: Improvements in motor function were observed among patients continuing Spinraza from Study CS3B, as well as those who initiated Spinraza in Study CS11 (Figure 3), with the greatest benefit observed in those with earlier treatment initiation.
Croatian: Poboljšanja motoričke funkcije uočena su u bolesnika koji su nastavili primati lijek Spinraza nakon ispitivanja CS3B, kao i u onih u kojih je Spinraza uvedena u ispitivanju CS11 (slika 3), pri čemu je veća korist primijećena u onih u kojih je liječenje počelo ranije.
English: There have been a small number of reports of patients developing hydrocephalus (a build-up of too much fluid around the brain) after Spinraza is given.
Croatian: U malog broja bolesnika zabilježen je razvoj hidrocefalusa (nakupljanja prevelike količine tekućine oko mozga) nakon što su primili lijek Spinraza.
English: This may not be required every time you or your child are given Spinraza.
Croatian: To ne mora biti potrebno svaki put kada Vi ili Vaše dijete trebate primiti lijek Spinraza.
English: Spinraza has no or negligible influence on the ability to drive and use machines.
Croatian: Upravljanje vozilima i strojevima Spinraza ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Pre-symptomatic infants
Croatian: Predsimptomatska dojenčad
English: The safety and efficacy in patients with renal impairment has not been established and they should be closely observed.
Croatian: Sigurnost i djelotvornost u bolesnika s oštećenjem funkcije bubrega nije ustanovljena te ih je potrebno pažljivo pratiti.
English: The mean CHOP INTEND score at last assessment was 61.0 (46 - 64) amongst patients with 2 SMN2 copies and 62.6 (58 - 64) amongst those with 3 SMN2 copies.
Croatian: Srednja vrijednost CHOP INTEND rezultata na zadnjoj procjeni bio je 61,0 (46 do 64) u bolesnika s 2 kopije SMN2 te 62,6 (58 do 64) u bolesnika s 3 kopije SMN2.
English: In the efficacy set, 18 patients (25%) in the Spinraza group and 12 patients (32%) in the sham-control group required permanent ventilation.
Croatian: U podskupini za ocjenu djelotvornosti, 18 bolesnika (25%) u skupini koja je primala lijek Spinraza i 12 bolesnika (32%) u kontrolnoj skupini u kojoj je proveden placebo postupak zahtijevalo je trajnu ventilaciju.
English: 5 ml in a Type I glass vial with bromobutyl rubber stopper and an aluminium over-seal and plastic cap.
Croatian: I od 5 ml s čepom od bromobutilne gume i aluminijskim prstenom i plastičnim zatvaračem.
English: At day 700, 7 out of 11 patients (64%) with 2 SMN2 gene copies and 0 out of 5 patients (0%) with 3 SMN2 copies, met the protocol-defined criteria of clinically manifested SMA, however, these patients were gaining weight and achieving WHO milestones, inconsistent with Type I SMA.
Croatian: Na 700. dan, 7 od 11 bolesnika (64 %) s 2 kopije gena SMN2 te 0 od 5 bolesnika (0 %) s 3 kopije SMN2 zadovoljavali su protokolom definirane kriterije za klinički manifestni SMA, no ti su bolesnici dobivali na tjelesnoj težini i postizali točke razvoja prema SZO-u, što nije sukladno tipu
English: Figure 3: Change in HINE Motor Milestones versus Study days for Study CS3B (treated and sham-control), CS3A, CS5 and CS11
Croatian: Slika 3: Promjena u ključnim točkama motoričkog razvoja prema pregledu HINE po danima ispitivanja za ispitivanja CS3B (liječena skupina i kontrolna skupina s placebom), CS3A, CS5 i CS11
English: How long to use Spinraza
Croatian: Koliko dugo primjenjivati lijek Spinraza
English: The population PK analysis suggests that race is unlikely to affect the PK of nusinersen.
Croatian: Populacijska farmakokinetička analiza pokazuje da rasa najvjerojatnije ne utječe na farmakokinetiku nusinersena.
English: Any unused product or waste material must be disposed of in accordance with local requirements.
Croatian: 10. Neiskorišteni lijek ili otpadni materijal mora se zbrinuti sukladno nacionalnim propisima.
English: If a maintenance dose is delayed or missed, Spinraza should be administered as soon as possible and dosing continued every 4 months.
Croatian: Ako se zakasni ili propusti doza održavanja, lijek Spinraza je potrebno primijeniti čim prije te nastaviti s doziranjem svaka 4 mjeseca.
English: Later onset
Croatian: Kasniji početak
English: Table 2: Primary and secondary endpoints at final analysis - Study CS3B Efficacy Parameter
Croatian: Tablica 2: Mjere primarnog i sekundarnog ishoda u završnoj analizi - ispitivanje CS3B Parametar djelotvornosti
English: Other products that are in the same group of medicines as Spinraza have been shown to affect the cells in the blood which help clotting.
Croatian: Pokazalo se da drugi lijekovi iz iste skupine lijekova kao i Spinraza utječu na krvne stanice koje pomažu zgrušavanje krvi.
English: The median age at first dose was 162 days.
Croatian: Medijan dobi u kojoj su primili prvu dozu iznosio je 162 dana.
English: In patients randomized to Spinraza in Study CS3B and including the experience in Study CS11, the median time to death or permanent ventilation was 73 weeks.
Croatian: U bolesnika randomiziranih u skupinu koja je u ispitivanju CS3B primala lijek Spinraza, uključujući iskustvo iz ispitivanja CS11, medijan vremena do smrti ili trajne ventilacije bio je 73 tjedna.
English: The primary endpoint, time to death or respiratory intervention (defined as invasive or non-invasive ventilation for ≥6 hours/day continuously for ≥7 consecutive days OR
Croatian: Primarni ishod, vrijeme do smrti ili respiratornu intervenciju (definirana kao invazivnu ili neinvazivnu ventilaciju tijekom ≥ 6 sati dnevno kontinuirano tijekom ≥ 7 uzastopnih dana ILI traheostomija) nije bilo moguće procijeniti jer je događaja bilo premalo.
English: Baseline disease characteristics were largely similar in the Spinraza treated patients and sham-control patients except that Spinraza treated patients at baseline had a higher percentage compared to sham-control patients of paradoxical breathing (89% vs 66%), pneumonia or respiratory symptoms (35% vs 22%), swallowing or feeding difficulties (51% vs 29%) and requirement for respiratory support (26% vs 15%).
Croatian: Početne značajke bolesti u bolesnika liječenih lijekom Spinraza i kontrolnih bolesnika u kojih je proveden placebo postupak bile su uglavnom slične, osim što su bolesnici liječeni lijekom Spinraza u usporedbi s kontrolnim bolesnicima na početku imali viši postotak paradoksalnog disanja (89% naspram 66%), pneumonije ili respiratornih simptoma (35% naspram 22%), poteškoća s gutanjem ili hranjenjem (51% naspram 29%) i potrebe za respiratornom potporom (26% naspram 15%).
English: Treatment should be administered by health care professionals experienced in performing lumbar punctures.
Croatian: Liječenje moraju provoditi zdravstveni radnici s iskustvom u izvođenju lumbalne punkcije.
English: Spinraza is given;
Croatian: Spinraza se daje:
English: The safety assessment of Spinraza was based on two Phase 3 clinical studies in infants (CS3B) and children (CS4) with SMA, together with one Phase 2 study in infants and children with SMA (CS7) and open-label studies including pre-symptomatic infants (CS5) genetically diagnosed with SMA and infants and children with SMA.
Croatian: Procjena sigurnosti lijeka Spinraza temeljila se na dva klinička ispitivanja faze 3 u dojenčadi (CS3B) i djece (CS4) sa SMA-om, zajedno s jednim ispitivanjem faze 2 u dojenčadi i djece sa SMA-om (CS7) te u otvorenim ispitivanjima u koja su bila uključena predsimptomatska dojenčad (CS5) s genetičkom dijagnozom SMA te dojenčad i djeca sa SMA-om.
English: If a loading dose is delayed or missed Spinraza should be administered as soon as possible, with at least 14 days between doses, and continue dosing at the prescribed frequency.
Croatian: Ako se zakasni ili propusti udarna doza, lijek Spinraza je potrebno primijeniti čim prije, u razmaku od najmanje 14 dana između doza, te nastaviti s doziranjem prema propisanoj učestalosti.
English: Spinraza is used to treat a genetic disease called spinal muscular atrophy (SMA).
Croatian: Spinraza se primjenjuje za liječenje genetske bolesti koja se naziva spinalna mišićna atrofija (SMA).
English: Study CS11 is an open label extension study for SMA patients who previously participated in the other Spinraza clinical studies.
Croatian: Ispitivanje CS11 otvoreni je produžetak ispitivanja za bolesnike sa SMA-om koji su prethodno sudjelovali u drugim kliničkim ispitivanjima lijeka Spinraza.
English: Ultrasound (or other imaging techniques) may be considered to guide intrathecal administration of Spinraza, particularly in younger patients and in patients with scoliosis.
Croatian: Može se razmotriti intratekalna primjena lijeka Spinraza vođena ultrazvukom (ili drugim slikovnim tehnikama), osobito u mlađih bolesnika i bolesnika sa skoliozom.
English: It is preferable to avoid the use of Spinraza during pregnancy and breast-feeding.
Croatian: Preporučuje se izbjegavati primjenu lijeka Spinraza tijekom trudnoće i dojenja.
English: Autopsy data from patients (n=3) show that nusinersen administered intrathecally is broadly distributed within the CNS achieving therapeutic levels in the target spinal cord tissues.
Croatian: Podaci iz obdukcije bolesnika (n=3) pokazuju da se intratekalno primijenjen nusinersen naširoko distribuira unutar SŽS-a, postižući terapijske razine u ciljnim tkivima kralježnične moždine.
English: Of those with observed values at Month 15, a higher proportion of Spinraza treated subjects had improvement (73% vs 41%, respectively) and a lower proportion of Spinraza treated subjects had worsening (23% vs 44%, respectively) in total HFMSE score compared to sham-control.
Croatian: Među bolesnicima sa zabilježenim vrijednostima u 15. mjesecu, veći udio onih liječenih Spinrazom imao je poboljšanje (73% naspram 41%), a manji udio pogoršanje (23% naspram 44%) ukupnog rezultata na ljestvici HFMSE u usporedbi s kontrolnim ispitanicima u kojih je proveden placebo postupak.
English: Median age of onset of clinical signs and symptoms was 56 days and patients had either 2 SMN2 gene copies (n=17) or 3 SMN2 gene copies (n=2) (SMN2 gene copy number unknown for 1 patient).
Croatian: Medijan dobi u kojoj su počeli klinički znakovi i simptomi iznosio je 56 dana i bolesnici su imali ili 2 kopije gena SMN2 (n=17) ili 3 kopije gena SMN2 (n=2) (broj kopija gena SMN2 nije bio poznat za 1 bolesnika).
English: Unopened vials of Spinraza can be removed from and returned to the refrigerator if necessary.
Croatian: Neotvorene bočice lijeka Spinraza mogu se izvaditi iz hladnjaka i ponovno vratiti u hladnjak po potrebi.
English: If clinically indicated, platelet and coagulation laboratory testing is recommended prior to administration of Spinraza.
Croatian: Ako je klinički indicirano, prije primjene lijeka Spinraza preporučuje se provesti laboratorijske testove trombocita i koagulacije.
English: Once drawn into the syringe, if the solution is not used within 6 hours, it must be discarded.
Croatian: Ako se otopinu uvučenu u štrcaljku ne primijeni unutar 6 sati, otopina se mora baciti.
English: Treatment with Spinraza should only be initiated by a physician with experience in the management of spinal muscular atrophy (SMA).
Croatian: Liječenje lijekom Spinraza smije započeti samo liječnik s iskustvom u liječenju spinalne mišićne atrofije (SMA).
English: Before you or your child are given Spinraza your doctor may decide to do a blood test to check that your or your child's blood can clot properly.
Croatian: Prije nego što Vi ili Vaše dijete primite lijek Spinraza, liječnik može odlučiti provesti pretrage krvi kako bi provjerio zgrušava li se krv pravilno.
English: In vitro studies indicated that nusinersen is not an inducer or inhibitor of CYP450-mediated oxidative metabolism and therefore should not interfere with other medicinal products for these metabolic pathways.
Croatian: Ispitivanja in vitro pokazala su da nusinersen nije ni induktor niti inhibitor oksidativnog metabolizma posredovanog CYP450 pa stoga ne bi trebao ometati druge lijekove koji koriste ove metaboličke puteve.
English: Figure 1: Change in CHOP INTEND from Baseline to Later of Day 183, Day 302, and Day 394 Study Visit - Endear Study /CS3B (Efficacy Set, ES)
Croatian: Slika 1: Promjena rezultata testa CHOP INTEND od početka do posljednjeg pregleda u ispitivanju na 183. dan, 302. dan ili 394. dan - ispitivanje Endear /CS3B (podskupina za ocjenu djelotvornosti)
English: Thrombocytopenia and coagulation abnormalities, including acute severe thrombocytopenia, have been observed after administration of other subcutaneously or intravenously administered antisense oligonucleotides.
Croatian: Poremećaji koagulacije i trombocitopenija, uključujući akutnu tešku trombocitopeniju, opaženi su nakon primjene drugih supkutano ili intravenski primijenjenih protusmjernih oligonukleotida.
English: The usual dose of Spinraza is 12 mg.
Croatian: Kako se daje lijek Spinraza Uobičajena doza lijeka Spinraza je 12 mg.
English: out of 20 patients (55%) met the endpoint of an increase in total CHOP INTEND score of ≥4 points as of the last study visit.
Croatian: Sveukupno je 11 od 20 bolesnika (55%) postiglo ishod povećanja ukupnog rezultata testa CHOP INTEND za ≥4 boda na njihovom posljednjem pregledu u tom ispitivanju.
English: Single- and multiple-dose pharmacokinetics (PK) of nusinersen, administered via intrathecal injection, were determined in paediatric patients diagnosed with SMA.
Croatian: Farmakokinetika jedne doze i višestrukih doza nusinersena, primijenjenog putem intratekalne injekcije, bila je utvrđena u pedijatrijskih bolesnika u kojih je dijagnosticirana SMA.
English: Biogen GmbH Tel: +49 (0) 89 99 6170
Croatian: Deutschland Biogen GmbH Tel: +49 (0) 89 99 6170
English: Each carton of Spinraza contains one vial.
Croatian: Jedna kutija lijeka Spinraza sadrži jednu bočicu.
English: At the interim analysis, all 25 (100%) patients had achieved the WHO motor milestone of sitting without support, 22 (88%) patients were walking with assistance.
Croatian: U trenutku interim analize svih 25 (100 %) bolesnika samostalno je sjedilo, što je ključna točka motoričkog razvoja prema SZO-u, a 22 bolesnika (88 %) hodalo je bez pomoći.
English: Of these patients, 6 (33%) in the Spinraza group and 0 (0%) in the sham-control group met the protocol-defined criteria for a motor-milestone responder.
Croatian: Od tih bolesnika, 6 (33%) u skupini koja je primala lijek Spinraza i 0 (0%) u kontrolnoj skupini zadovoljilo je kriterije odgovora na liječenje s obzirom na postignute ključne točke motoričkog razvoja definirane planom ispitivanja.
English: EU/1/17/1188/001
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1188/001
English: An improvement in mean CHOP INTEND score over time was observed from baseline to day 1072 (mean change 21.30).
Croatian: Bilo je opaženo poboljšanje srednje vrijednosti rezultata testa CHOP INTEND tijekom vremena od početka do 1072. dana (srednja vrijednost promjene: 21,30).
English: The pharmacokinetics of nusinersen in patients with renal or hepatic impairment has not been studied.
Croatian: Farmakokinetika nusinersena u bolesnika s oštećenjem funkcije bubrega ili jetre nije ispitana.
English: Table 3: Primary and secondary endpoints at final analysis - Study CS41 Spinraza treated Patients
Croatian: Tablica 3: Mjere primarnog i sekundarnog ishoda u završnoj analizi - ispitivanje CS41 Bolesnici liječeni lijekom Spinraza
English: Side effects related to the lumbar puncture may occur while Spinraza is being given or afterwards.
Croatian: Nuspojave povezane s lumbalnom punkcijom mogu se javiti tijekom ili nakon davanja lijeka Spinraza.
English: 3At the final analysis, CHOP INTEND and motor milestone analyses were conducted using the Efficacy Set (Spinraza n=73; Sham-control n=37).
Croatian: 3U završnoj analizi, analize rezultata testa CHOP INTEND i ocjene ključnih točki motoričkog razvoja provedene su na podskupini za ocjenu djelotvornosti (Spinraza n=73; kontrola n=37).
English: The primary route of elimination is expected via urinary excretion of nusinersen and its metabolites.
Croatian: Očekivani primarni put eliminacije nusinersena i njegovih metabolita je izlučivanje mokraćom.
English: Some patients were implanted with a ventriculo-peritoneal shunt.
Croatian: Nekim je bolesnicima bio ugrađen ventrikuloperitonealni drenažni sustav (šant, engl. shunt).
English: Median age at first dose was 22 days.
Croatian: Medijan dobi kad su primili prvu dozu iznosio je 22 dana.
English: The median age when patients received their first dose was 164.5 days for treated patients, and 205 days for sham-control.
Croatian: Medijan dobi u kojoj su bolesnici primili prvu dozu iznosio je 164,5 dana u liječenih bolesnika i 205 dana u kontrolnih bolesnika u kojih je proveden placebo postupak.
English: required respiratory intervention >6 hours/day continuously for ≥7 days, all of whom initiated ventilatory support during an acute reversible illness
Croatian: Za četiri bolesnika (2 kopije SMN2) bila je potrebna respiratorna intervencija tijekom > 6 sati dnevno kontinuirano tijekom ≥ 7 uzastopnih dana, a u svih je njih ventilatorna podrška uvedena tijekom akutne reverzibilne bolesti.
English: The protocol-defined criteria for clinically manifested SMA included age-adjusted weight below the fifth WHO percentile, a decrease of 2 or more major weight growth curve percentiles, the placement of a percutaneous gastric tube, and/or the inability to achieve expected age-appropriate WHO milestones (sitting without support, standing with assistance, hands-and-knees crawling, walking with assistance, standing alone and walking alone).
Croatian: Protokolom definirani kriteriji za klinčki manifestni SMA uključivali su dobno prilagođenu težinu ispod petog percentila SZO-a, smanjenje za 2 ili više glavnih percentila krivulje rasta težine, postavljanje perkutane gastrostome i/ili nemogućnost postizanja očekivanih ključnih točki motoričkog razvoja primjerenih dobi prema SZO-u (samostalno sjedenje, stajanje uz pomoć, puzanje četveronoške, hodanje uz pomoć, samostalno stajanje i samostalno hodanje).
English: Intrathecal injection of nusinersen into the CSF allows nusinersen to be fully available for distribution from the CSF to the target central nervous system (CNS) tissues.
Croatian: Intratekalna injekcija nusinersena u cerebrospinalni likvor omogućuje nusinersenu u cerebrospinalnom likvoru da se u potpunosti distribuira do ciljnih tkiva u središnjem živčanom sustavu (SŽS).
English: Spinal muscular atrophy is caused by a shortage of a protein called survival motor neuron (SMN) in the body.
Croatian: Spinalnu mišićnu atrofiju uzrokuje nedostatak proteina u tijelu koji se naziva protein za preživljenje motoričkog neurona, ili skraćeno na engleskom „SMN“.
English: There are no or limited amount of data from the use of nusinersen in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni nusinersena u trudnica ograničeni.
English: In vitro studies indicated that nusinersen is not an inducer or inhibitor of CYP450 mediated metabolism.
Croatian: In vitro ispitivanja pokazala su da nusinersen nije ni induktor niti inhibitor metabolizma posredovanog CYP450.
English: Prior to administration, unopened vials of Spinraza can be removed from and returned to the refrigerator if necessary.
Croatian: Prije primjene, neotvorene bočice lijeka Spinraza mogu se izvaditi iz hladnjaka i ponovno vratiti u hladnjak po potrebi.
English: Change from baseline in total HFMSE score at 15 months1,2,3
Croatian: HFMSE rezultat Promjena od početne vrijednosti ukupnog HFMSE rezultata u 15. mjesecu1,2,3
English: Figure 2: Mean change from baseline in HFMSE score over time at final analysis (ITT)Study CS4 1,2
Croatian: Slika 2: Srednja vrijednost promjene u odnosu na početni rezultat HFMSE tijekom vremena, završna analiza (ITT) - ispitivanje CS41,2
English: Biogen Idec Limited Tel: +44 (0) 1628 50 1000
Croatian: United Kingdom Biogen Idec Limited Tel: +44 (0) 1628 50 1000
English: Patients who initiated Spinraza treatment in Study CS11 (n=20) had a median age of 4.0 years (range 3 - 8 years).
Croatian: Medijan dobi bolesnika u kojih je liječenje lijekom Spinraza počelo tijekom ispitivanja CS11 (n = 20) bio je 4,0 godina (raspon od 3 do 8 godina).
English: Study CS5 (NURTURE) is an open-label study in pre-symptomatic infants genetically diagnosed with SMA, who were enrolled at 6 weeks of age or younger.
Croatian: Ispitivanje CS5 (NURTURE) otvoreno je ispitivanje u predsimptomatske dojenčadi s genetičkom dijagnozom SMA, koja je bila uključena u ispitivanje u dobi od 6 tjedana ili manje.
English: 4 Assessed using the Month 15 Efficacy Set (Spinraza n=66; Sham control n=34); analyses are based on imputed data when there are missing data.
Croatian: 4Procjena na temelju podskupine za ocjenu djelotvornosti u 15. mjesecu (Spinraza n=66; kontrola placebo postupkom n=34); kad su podaci nedostajali, analize su provedene na temelju imputiranih podataka.
English: Of the twelve patients (50%) who had not met the definition of permanent ventilation in Study CS3B, 7 patients (58%) were alive without permanent ventilation in Study CS11.
Croatian: Od dvanaest bolesnika (50 %) koji nisu zadovoljili kriterije definicije trajne ventilacije u ispitivanju CS3B, u ispitivanju CS11 bilo je živo bez trajne ventilacije 7 bolesnika (58 %).
English: Infant Test for Neuromuscular Disease (CHOP INTEND) score were observed in patients in the Spinraza group compared to those in the sham-control group (Table 2).
Croatian: Children's Hospital of Philadelphia Infant Test for Neuromuscular Disease, CHOP INTEND) u bolesnika u skupini koja je primala lijek Spinraza u usporedbi s onima u kontrolnoj skupini u kojih je proveden placebo postupak (tablica 2).