FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor if you or your child is taking, has recently taken, or might take any other medicines.
Croatian: Obavijestite svog liječnika ako Vi ili Vaše dijete uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Will have obvious instability, and may have intermittent falls.
Croatian: Pokazat će se očigledna nestabilnost i može doći do povremenih padova.
English: • Two single-use syringes compatible with the pump equipment.
Croatian: • Dvije štrcaljke za jednokratnu uporabu kompatibilne s opremom pumpe.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before treatment with this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: CSF (N=17) Mean (SD)
Croatian: CSF (N = 17) Prosjek (SD)
English: Genotoxicity, carcinogenicity and reproductive toxicity investigations have not been performed.
Croatian: Nisu provedena ispitivanja genotoksičnosti, kancerogenosti i reproduktivne toksičnosti.
English: These precautions are of particular importance in patients below 3 years of age.
Croatian: Ove mjere opreza posebno su važne u bolesnika mlađih od 3 godine.
English: What Brineura is and what it is used for
Croatian: Što je Brineura i za što se koristi
English: Figure 1: Infusion System Set Up
Croatian: Slika 1: Postavljeni infuzijski sustav
English: Convulsions are a common manifestation of CLN2 disease and are expected to occur in this population.
Croatian: Konvulzije su česta manifestacija bolesti CLN2 i očekivane su u ovoj populaciji.
English: Contents of the pack and other information What Brineura contains
Croatian: Sadržaj pakiranja i druge informacije Što Brineura sadrži
English: So far safety results in younger patients appears consistent with the safety profile observed in older children.
Croatian: Do sada se rezultati sigurnosti u mlađih bolesnika čine sukladni sa sigurnosnim profilom opaženim u starije djece.
English: Treatment should be based on the benefits and risks to the individual patient as assessed by the physician.
Croatian: Liječenje se treba temeljiti na koristima i rizicima za pojedinačnog bolesnika prema procjeni liječnika.
English: • Syringe: Braun and BD Luer-Lok
Croatian: • štrcaljka: Braun i BD Luer-Lok
English: The recommended dose of Brineura is based upon your or your child's age, and is given once every other week as follows:
Croatian: Preporučena doza lijeka Brineura temelji se na Vašoj dobi ili dobi Vašega djeteta, a primjenjivat će se jednom svaki drugi tjedan:
English: 1 Requires external assistance to walk, or can crawl only.
Croatian: Potrebna pomoć pri hodu ili može samo puzati.
English: The medicine and solution will be given over about 2 to 4 hours and 30 minutes according to your or your child's dose.
Croatian: Davanje lijeka i otopine trajat će oko 2 - 4 sata i 30 minuta, ovisno o Vašoj dozi ili dozi Vašega djeteta.
English: Five patients experienced a single point decrease, and 3 patients experienced a 2 point decrease.
Croatian: Pet bolesnika imalo je smanjenje od jednog boda, a 3 bolesnika imala su smanjenje od 2 boda.
English: Pre-treatment of patients with antihistamines with or without antipyretics is recommended 30 to 60 minutes prior to the start of infusion.
Croatian: Preporučuje se predliječenje bolesnika antihistaminicima, s antipireticima ili bez njih, 30 do 60 minuta prije početka infuzije.
English: A length of 150 to 206 cm (not to exceed 400 cm) and an inner diameter of 0.1 cm is recommended.
Croatian: Preporučuje se duljina od 150 do 206 cm (ne dulje od 400 cm) i unutrašnji promjer od 0,1 cm.
English: After long periods of use, the access device may need to be replaced and will be determined by your doctor.
Croatian: Nakon dugotrajnog razdoblja primjene može biti potrebno zamijeniti pomagalo za pristup, a to će utvrditi Vaš liječnik.
English: Consideration of dose adjustments may be necessary for patients who may not tolerate the infusion.
Croatian: Prilagodbu doze može biti potrebno uzeti u obzir u bolesnika koji ne podnose infuziju.
English: Hypersensitivity reactions were reported in 14 out of 24 patients (58%) treated with Brineura.
Croatian: Reakcije preosjetljivosti zabilježene su u 14 od 24 bolesnika (58%) liječena lijekom Brineura.
English: If you or your child has a history of heart problems, your doctor or nurse will monitor your heart activity during each infusion.
Croatian: Ako ste Vi ili Vaše dijete prije imali srčanih tegoba, liječnik ili medicinska sestra pratit će aktivnost srca tijekom svake infuzije.
English: Clinical and laboratory monitoring
Croatian: Kliničko i laboratorijsko praćenje
English: Your doctor will check for abnormal heart electrical activities (ECG) every 6 months.
Croatian: Liječnik će provjeravati odstupanja od normalne električne aktivnosti srca (EKG) svakih 6 mjeseci.
English: 1 year to < 2 years: 200 mg (first 4 doses), 300 mg (all other doses) ≥ 2 years: 300 mg
Croatian: 1 godina do < 2 godine: 200 mg (prve 4 doze), 300 mg (sve ostale doze) ≥ 2 godine: 300 mg.
English: Brineura contains sodium:
Croatian: Brineura sadrži natrij:
English: Your doctor will discuss whether Brineura treatment is right for you or your child.
Croatian: Liječnik će razmotriti da li je liječenje lijekom Brineura ispravno za vas i vaše dijete.
English: This disease model primarily served to investigate the pharmacodynamic and pharmacokinetic properties of cerliponase alfa, but also aimed to evaluate the toxicity of the substance.
Croatian: Ovaj model bolesti prvenstveno je služio za istraživanje farmakodinamičkih i farmakokinetičkih svojstava cerliponaze alfa, ali je također imao za cilj procijeniti i toksičnost te tvari.
English: The doctor may decide on additional monitoring if it is needed.
Croatian: Ako je potrebno, liječnik može odlučiti o dodatnom praćenju.
English: The posology selected for patients is based on age at time of treatment and should be adjusted accordingly (see Table 1).
Croatian: Doziranje odabrano za bolesnike temelji se na dobi u vrijeme liječenja i prema tome ga je potrebno prilagoditi (vidjeti Tablicu 1).
English: Condensation will occur during thawing period.
Croatian: Tijekom odmrzavanja doći će do kondenzacije.
English: Non-interventional post-authorisation safety study (PASS): Study 190-501.
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PASS): ispitivanje 190-501.
English: There were no patients with advanced disease progression at treatment initiation who were included in clinical trials and no clinical data is available in children < 2 years.
Croatian: Nije bilo bolesnika s napredovanjem već uznapredovale bolesti na početku liječenja a koji su uključeni u klinička ispitivanja i nema dostupnih kliničkih podataka za djecu < 2 godine.
English: Other medicines and Brineura
Croatian: Drugi lijekovi i Brineura
English: What Brineura looks like and contents of the pack
Croatian: Kako Brineura izgleda i sadržaj pakiranja
English: Do not thaw or warm vials any other way.
Croatian: Bočice ne odmrzavajte ili ne zagrijavajte na neki drugi način.
English: Treatment may be interrupted if the device needs to be replaced or until the infection clears.
Croatian: Liječenje može biti prekinuto ako pomagalo treba zamijeniti ili dok se ne izliječi infekcija.
English: - If you or your child has had life-threatening allergic reactions to cerliponase alfa or any of the other ingredients of this medicine (listed in section 6), and the reactions continue to happen when cerliponse alfa is given again.
Croatian: - Ako ste Vi ili Vaše dijete imali po život opasne alergijske reakcije na cerliponazu alfa ili bilo koji drugi sastojak ovoga lijeka (naveden u dijelu 6), a reakcije se nastavljaju javljati kada ponovno primite cerliponazu alfa.
English: When compared to the expected rate of decline based on natural history, the study results are statistically significant (p < 0.0001) (see Table 4).
Croatian: Kada se to usporedi s očekivanom brzinom propadanja funkcija kod prirodnog tijeka bolesti, rezultati ispitivanja statistički su značajni (p < 0,0001) (vidjeti tablicu 4).
English: In patients less than 2 years of age, lower doses are recommended, see paediatric population section.
Croatian: U bolesnika mlađih od 2 godine preporučuju se niže doze, vidjeti dio o pedijatrijskoj populaciji.
English: These studies used the aggregate of the motor and language domains of a disease-specific clinical rating scale (see Table 3) to assess disease progression.
Croatian: U ovim ispitivanjima upotrijebljen je skup motoričkih i jezičnih domena kliničke ocjenske ljestvice koje su specifične za bolest (vidjeti tablicu 3) kako bi se procijenilo napredovanje bolesti.
English: Inadequate levels of TPP1 cause CLN2 disease, resulting in neurodegeneration, loss of neurological function and death during childhood.
Croatian: Neodgovarajuće razine TPP1 uzrokuju bolest CLN2, što rezultira neurodegeneracijom, gubitkom neurološke funkcije i smrću u djetinjstvu.
English: These naturally occurring particles are cerliponase alfa.
Croatian: Te prirodno nastale čestice su cerliponaza alfa.
English: The posology proposed in children below 2 years has been estimated based on brain mass.
Croatian: Doziranje predloženo za djecu mlađu od 2 godine procijenjeno je na temelju mase mozga.
English: Brineura must be administered using aseptic technique to reduce the risk of infection.
Croatian: Brineura se mora primijeniti aseptičnom tehnikom kako bi se smanjio rizik od infekcije.
English: An extension line may be added if needed.
Croatian: Ako je potrebno, može se dodati produžetak infuzijske linije.
English: The activated proteolytic enzyme (rhTPP1) cleaves tripeptides from the N-terminus of the target protein with no known substrate specificity.
Croatian: Aktivirani proteolitički enzim (rhTPP1) cijepa tripeptide s N-terminalnog kraja ciljnog proteina, s time da nema poznate specifičnosti za supstrat.
English: No correlations were found between higher ADA titres and reductions in efficacy measurements.
Croatian: Nisu nađene korelacije između viših ADA titara i smanjenja u mjerenjima djelotvornosti.
English: • Program the pump alarms to sound at the most sensitive settings for pressure, rate, and volume limits.
Croatian: • Programirajte zvučne signale upozorenja pumpe na najveću osjetljivost na promjene ograničenja za tlak, brzinu i volumen.
English: • Two single-use hypodermic syringe needles, (21 G, 25.4 mm).
Croatian: • Dvije hipodermalne igle za štrcaljke za jednokratnu uporabu (21 G, 25,4 mm).
English: No fertility studies with cerliponase alfa have been conducted in animals or humans.
Croatian: Nisu provedena ispitivanja plodnosti s cerliponazom alfa u životinja ili ljudi.
English: The dose may be reduced by 50% and/or the infusion rate decreased to a slower rate.
Croatian: Doza se može smanjiti za 50% i/ili usporiti brzina primjene infuzije.
English: • Secure the components per institution standard of care.
Croatian: • Učvrstite komponente prema standardima skrbi ustanove.
English: The pharmacokinetic parameters in CSF were assessed in 17 patients and are summarized in Table 5 below.
Croatian: Farmakokinetički parametri u CSF-u bili su procijenjeni u 17 bolesnika, a sažeto su prikazani u tablici 5 u nastavku.
English: There are no data on the presence of cerliponase alfa in human milk, the effects of cerliponase alfa on the breastfed child, or the effects of cerliponase alfa on milk production.
Croatian: Nema podataka o prisutnosti cerliponaze alfa u majčinu mlijeku, učincima cerliponaze alfa na dojenče ili o učincima cerliponaze alfa na proizvodnju mlijeka.
English: A total of 15 patients out of 23 (65%) had no overall decline in CLN2 score, irrespective of baseline score, and 2 of these 15 patients increased their score by one point during the treatment period.
Croatian: Od 23 (65%) bolesnika, ukupno 15 bolesnika nije imalo ukupno sniženje rezultata za CLN2 bez obzira na početni rezultat, a 2 od tih 15 bolesnika povećala su svoj rezultat za jedan bod tijekom razdoblja liječenja.
English: Cerliponase alfa is a recombinant form of human tripeptidyl peptidase-1 (rhTPP1).
Croatian: Cerliponaza alfa rekombinantni je oblik ljudske tripeptidil-peptidaze 1 (rhTPP1).
English: 6 months to < 1 year: 150 mg
Croatian: 6 mjeseci do < 1 godine: 150 mg
English: Mean (SD)
Croatian: Prosjek (SD)
English: If the infusion is interrupted due to a hypersensitivity reaction, it should be restarted at approximately onehalf the initial infusion rate at which the hypersensitivity reaction occurred.
Croatian: Ako se primjena infuzije prekine zbog reakcije preosjetljivosti, treba je ponovno započeti brzinom približno upola manjom od početne brzine infuzije pri kojoj je nastupila reakcija preosjetljivosti.
English: Brineura contains the active substance cerliponase alfa, which belongs to a group of medicines known as enzyme replacement therapies.
Croatian: Brineura sadrži djelatnu tvar cerliponazu alfa, koja pripada skupini lijekova poznatih kao enzimska nadomjesna terapija.
English: Patients who experienced moderate hypersensitivity adverse events were tested for drug-specific IgE and found to be negative.
Croatian: Bolesnici u kojih su se javili događaji umjerene preosjetljivosti testirani su na IgE specifičan za lijek i ustanovljeno je da su negativni.
English: Cerliponase alfa is a proteolytic inactive proenzyme (zymogen) that is activated in the lysosome.
Croatian: Cerliponaza alfa je proteolitički neaktivan proenzim (zimogen) koji se aktivira u lizosomu.
English: *Tmax expressed as time since start of ~4 hour infusion and presented as median [min, max], and occurred at the first sampling timepoint post infusion
Croatian: *Tmax vrijednost izražena kao vrijeme od početka infuzije u trajanju ~4 sata i navedeno kao medijan [min, maks], a odnosi se na vremensku točku prvog uzorkovanja nakon infuzije.
English: The inline filter should be placed as close as practically possible to the port needle.
Croatian: Ugrađeni filtar treba biti postavljen koliko god je praktično moguće bliže ulaznoj igli.
English: Talk to your doctor if you have any questions about your device.
Croatian: Obratite se liječniku ako imate pitanja o pomagalu koji Vam je usađen.
English: 6.7 (first 4 doses) 10 (subsequent doses)
Croatian: 6,7 (prve 4 doze) 10 (kasnije doze)
English: 2 years and older
Croatian: 2 godine i nadalje
English: Motor
Croatian: Motorička
English: It is important to initiate treatment in children as young as possible, although patients less than 3 years of age were not included in the pivotal study.
Croatian: Važno je liječenje započeti u što mlađe djece, iako u glavno ispitivanje nisu bila uključena djeca mlađa od 3 godine.
English: Pharmacotherapeutic group: other alimentary tract and metabolism products, enzymes, ATC code: A16AB17.
Croatian: Farmakoterapijska skupina: drugi lijekovi za probavni sustav i metabolizam, enzimi, ATK oznaka: A16AB17.
English: • A non-coring port needle with a gauge of 22 or smaller and a suggested length of 16 mm.
Croatian: • Ulazna igla (non-coring) promjera 22 G ili manje, po mogućnosti duljine 16 mm.
English: Your doctor may adjust you or your child's dose or the amount of time the medicine is given if the infusion is not tolerated, there is an allergic reaction or there is a possible increase of pressure in the brain.
Croatian: Liječnik može Vama ili Vašem djetetu prilagoditi dozu ili vrijeme davanja lijeka ako se infuzija ne podnosi, ako se pojavi alergijska reakcija ili možda postoji porast tlaka u mozgu.
English: It is not known whether Brineura can cause foetal harm when administered to a pregnant woman or can affect reproductive capacity.
Croatian: Nije poznato može li Brineura prouzročiti oštećenje fetusa kad se primjenjuje u trudnica ili može li utjecati na reproduktivnu sposobnost.
English: *Cerliponase alfa is produced in mammalian Chinese Hamster Ovary cells.
Croatian: *Cerliponaza alfa proizvedena je u stanicama jajnika kineskog hrčka.
English: Continuation of long-term treatment should be subject to regular clinical evaluation whether the benefits are considered to outweigh the potential risks to individual patients.
Croatian: Nastavak dugoročnog liječenja potrebno je redovito klinički procjenjivati kako bi se ustanovilo nadmašuju li koristi potencijalne rizike za svakog pojedinog bolesnika.
English: CLN2 patients with ventriculo-peritoneal shunts.
Croatian: Bolesnici s CLN2 koji imaju ventrikulo-peritonejski spoj (shunt).
English: In study 190201, 23 patients were treated for 48 weeks (1 patient withdrew after week 1 due to the inability to continue with study procedures).
Croatian: U ispitivanju 190-201, 23 bolesnika liječena su 48 tjedana (1 bolesnik povukao se iz ispitivanja nakon 1 tjedna zbog nemogućnosti da nastavi s postupcima u ispitivanju).
English: 200 (first 4 doses) 300 (subsequent doses)
Croatian: 200 (prve 4 doze) 300 (kasnije doze)
English: Table 1: Dose and volume of Brineura
Croatian: Tablica 1: Doza i volumen lijeka Brineura
English: Both patients have received 8 infusions and the overall safety profile of Brineura in these younger patients appears consistent with the safety profile observed in older children.
Croatian: Oba bolesnika primila su 8 infuzija i ukupni sigurnosni profil lijeka Brineura u tih mlađih bolesnika čini se dosljedan sigurnosnom profilu u starije djece.
English: Study 190-203 is an ongoing open label clinical study evaluating the safety and efficacy in patients from birth to 18 years of age.
Croatian: Ispitivanje 190-203 otvoreno je kliničko ispitivanje koje još traje, a njime se procjenjuju sigurnost i djelotvornost u bolesnika od rođenja do 18. godine.
English: Upon completion of the infusion, the patient status should be clinically assessed and observation may be necessary for longer periods if clinically indicated, particularly in patients less than 3 years.
Croatian: Kada infuzija završi, potrebno je klinički procijeniti status bolesnika, a ako je klinički indicirano, može biti potrebno promatrati bolesnika duže vrijeme, osobito u slučaju bolesnika mlađih od 3 godine.
English: Consequently, impaired liver function is not expected to affect the pharmacokinetics of cerliponase alfa.
Croatian: Prema tome, ne očekuje se da će oštećena funkcija jetre utjecati na farmakokinetiku cerliponaze alfa.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Brineura in one or more subsets of the paediatric population in CLN2 (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Brineura u jednoj ili više podskupina pedijatrijske populacije za CLN2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: - If you or your child has a device implanted to drain extra fluid from the brain.
Croatian: - Ako Vi ili Vaše dijete imate usađeno pomagalo za odvođenje viška tekućine iz mozga.
English: You should not receive Brineura treatment during pregnancy unless clearly necessary.
Croatian: Ne biste trebali primati liječenje lijekom Brineura tijekom trudnoće osim ako nije neophodno.
English: The most commonly reported convulsion events include seizure, epilepsy and generalized tonic-clonic seizure.
Croatian: Najčešće zabilježeni događaji konvulzije uključuju napadaj, epilepsiju i generalizirani toničko-klonički napadaj.
English: The observed treatment effect was considered clinically meaningful in light of the natural history of untreated CLN2 disease.
Croatian: Opaženi učinak liječenja smatrao se klinički značajnim u svjetlu podataka o prirodnom tijeku neliječene bolesti CLN2.
English: Electrocardiogram (ECG) monitoring during infusion should be performed in patients with a history of bradycardia, conduction disorder, or with structural heart disease, as some patients with CLN2 disease may develop conduction disorders or heart disease.
Croatian: Praćenje elektrokardiograma (EKG) tijekom infuzije treba provoditi u bolesnika s anamnezom bradikardije, poremećajem provodljivosti ili strukturnom srčanom bolešću, jer neki bolesnici s bolešću CLN2 mogu razviti poremećaj provodljivosti ili srčanu bolest.
English: Vital signs should be monitored before infusion starts, periodically during infusion, and post-infusion in a healthcare setting.
Croatian: Vitalne znakove treba pratiti prije početka infuzije, redovito tijekom infuzije i poslije infuzije u bolničkom okruženju.
English: frequency convention defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Language
Croatian: Jezična
English: Posology was based upon analysis of differences in brain mass values for children less than 3 years of age.
Croatian: Doziranje se temeljilo na analizi razlika u vrijednostima za masu mozga u djece mlađe od 3 godine.
English: Your doctor will check your or your child's heart rate, blood pressure, respiratory rate, and temperature before, during, and after treatment.
Croatian: Liječnik će Vama ili Vašem djetetu provjeriti brzinu srčanih otkucaja, krvni tlak, brzinu disanja i tjelesnu temperaturu prije, tijekom i poslije liječenja.
English: Findings from studies 190-201 and 190-202 were compared with a natural history control group that included patients that satisfied the inclusion criteria for studies 190-201 and 190-202.
Croatian: Rezultati ispitivanja 190-201 i 190-202 uspoređeni su s kontrolnom skupinom s prirodnim tijekom bolesti, koja je uključivala bolesnike koji su ispunjavali kriterije uključivanja za ispitivanja 190-201 i 190-202.
English: However, these signs may also occur in the context of device-related infections.
Croatian: Međutim, ti se znakovi mogu javiti i u slučaju infekcija povezanih s pomagalom.
English: p-valueb
Croatian: p-vrijednostb
English: The estimated volume of distribution of cerliponase alfa following intracerebroventricular infusion of 300 mg (Vz = 435 ml) exceeds the typical CSF volume (100 ml), suggesting distribution to tissues outside the CSF.
Croatian: Procijenjeni volumen distribucije cerliponaze alfa nakon intracerebroventrikularne infuzije od 300 mg (Vz = 435 ml) premašuje tipični volumen CSF-a (100 ml), što ukazuje na distribuciju u tkiva izvan CSF-a.
English: • Do not return CSF to the intracerebroventricular access device.
Croatian: • Ne vraćajte CSF u pomagalo za intracerebroventrikularni pristup.
English: Brineura is compatible with disposable infusion components made of PVC, PVC (non-DEHP) polyethylene, polyethersulfone (PES), polypropylene (PP), and PTFE.
Croatian: Brineura je kompatibilna s komponentama za infuziju za jednokratnu primjenu izrađenim od polivinilklorida (PVC), PVC-a (bez DEHP-a), polietilena, polietersulfona (PES), polipropilena (PP) i politetrafluoroetilena (PTFE).
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Croatian: POSEBNE OBVEZE ZA ISPUNJAVANJE MJERA NAKON DAVANJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
English: Your doctor may lower the dose or the speed of the infusion based on your response during the treatment.
Croatian: Liječnik može smanjiti dozu ili usporiti brzinu infuzije, ovisno o tome kako reagirate tijekom terapije.
English: The most common manifestations included pyrexia with vomiting, pleocytosis, or irritability, which are inconsistent with classic immune mediated hypersensitivity.
Croatian: Najčešće manifestacije uključivale su pireksiju s povraćanjem, pleocitozu ili iritabilnost, što nije dosljedno s klasičnom imunološki posredovanom preosjetljivošću.
English: Volume of Brineura solution (ml)
Croatian: Volumen otopine lijeka Brineura (ml)