FrancophonIA/ELRC3.0 huggingface dataset:
English: The medicine is slowly pumped through the implanted device.
Croatian: Lijek se polagano pumpa kroz usađeno pomagalo.
English: It is not known if Brineura will impact the ability to drive or use machines.
Croatian: Nije poznato hoće li Brineura utjecati na sposobnost upravljanja vozilima ili rada sa strojevima.
English: Currently no clinical experience of Brineura in children below 2 years of age is available (see section 4.8).
Croatian: Trenutačno nema kliničkih iskustava s lijekom Brineura u djece mlađe od 2 godine (vidjeti dio 4.8).
English: Table 4: 0 to 6 Point Motor-Language CLN2 Clinical Rating Scale: Rate of Decline over 48 weeks (Intent to Treat (ITT) population)
Croatian: Tablica 4: Klinička ocjenska ljestvica za procjenu motoričke-jezične funkcije od 0 do 6 bodova kod CLN2: brzina propadanja funkcija u 48 tjedana (populacija predviđena za liječenje, ITT)
English: • A programmable syringe pump with appropriate delivery range, delivery rate accuracy, and alarms for incorrect delivery or occlusion.
Croatian: • Pumpa sa štrcaljkom koju se može programirati na odgovarajući raspon protoka infuzije, točnu brzinu protoka i signale upozorenja u slučaju nepravilnog protoka ili začepljenosti.
English: Do not dilute Brineura.
Croatian: Nemojte razrjeđivati lijek Brineura.
English: In clinical studies, antibiotics were administered, the intracerebroventricular access device was replaced, and Brineura treatment was continued.
Croatian: U kliničkim ispitivanjima bili su primijenjeni antibiotici, pomagalo za intracerebroventrikularni pristup je zamijenjen, a liječenje lijekom Brineura nastavljeno.
English: Do not use this medicine after the expiry date, which is stated on the vials and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake EXP.
English: Detach and remove the empty syringe from the pump and disconnect from the tubing.
Croatian: Izvadite praznu štrcaljku iz pumpe i odvojite je od linije.
English: From a microbiological point of view, open vials or medicinal product held in syringes should be used immediately.
Croatian: S mikrobiološkog stajališta, otvorene bočice ili lijek u štrcaljkama treba upotrijebiti odmah.
English: Your doctor may give you or your child medicines, such as antipyretics to reduce fever or antihistamines to treat allergic reactions before each treatment with Brineura to reduce side effects that can occur during or shortly after treatment.
Croatian: Prije svake terapije lijekom Brineura, liječnik može Vama ili Vašem djetetu dati lijekove kao što su antipiretici koji snižavaju vrućicu ili antihistaminike za liječenje alergijskih reakcija, kako bi se smanjile nuspojave koje se mogu javiti tijekom ili ubrzo nakon terapije.
English: In two clinical cases, the ICV access devices did not show signs of failure at the time of infusion; however, after removal, material degradation of the devices were apparent and consistent with data from benchtop testing of ICV access devices.
Croatian: U dva klinička slučaja, pomagala za intracerebroventrikularni pristup nisu pokazala znakove kvara prilikom infuzije; međutim, nakon uklanjanja, degradacija materijala pomagala bila je očigledna i u skladu s podacima iz laboratorijskog testiranja pomagala za intracerebroventrikularni pristup.
English: Thawing the vials outside the carton is recommended.
Croatian: Preporučuje se odmrzavanje izvan kartonske kutije.
English: In the ongoing study 190-202 (as of 03 June 2016), the rate of decline in patients treated with Brineura compared to the natural history control group (N=42 patients) continues to show durability of the treatment effect (see Figure 2).
Croatian: U ispitivanju 190-202 koje još traje (na dan 3. lipnja 2016.), brzina propadanja u bolesnika liječenih lijekom Brineura u usporedbi s kontrolnom skupinom s prirodnim tijekom bolesti (N = 42 bolesnika) nastavlja pokazivati postojanost učinka liječenja (vidjeti sliku 2).
English: CSF samples should routinely be sent for infection monitoring (see section 4.4).
Croatian: Uzorke CSF-a treba rutinski slati na provjeru prisutnosti infekcija (vidjeti dio 4.4).
English: Brineura and flushing solution must be completely thawed and used immediately (see section 6.3).
Croatian: Brineura i otopina za ispiranje moraju se potpuno odmrznuti i odmah upotrijebiti (vidjeti dio 6.3).
English: Intracerebroventricular access device-related infections, including sub-clinical infections and meningitis, have been observed in patients treated with Brineura.
Croatian: Infekcije povezane s pomagalom za intracerebroventrikularni pristup, uključujući supkliničke infekcije i meningitis, zabilježene su u bolesnika liječenih lijekom Brineura.
English: Brineura will be given by a doctor with knowledge of giving medicines by intracerebroventricular use (infusion into the fluid of the brain) in a hospital or clinic.
Croatian: Lijek Brineura daje liječnik s iskustvom u davanju lijekova intracerebroventrikularnim putem (infuzija u tekućinu mozga) u bolnici ili klinici.
English: No prominent ataxia, no pathologic falls.
Croatian: Bez očite ataksije, bez patoloških padova.
English: Do not mix Brineura with any other medicinal product.
Croatian: Ne miješajte lijek Brineura ni s jednim drugim lijekom.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se ne upotrijebi odmah, vrijeme i uvjeti čuvanja lijeka u primjeni prije uporabe odgovornost su korisnika.
English: It is not known whether Brineura is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se Brineura majčinim mlijekom.
English: You or your child may get problems with the implanted device used during treatment with Brineura (see section 4 “Possible side effects”), including infection or a fault in the device.
Croatian: Tijekom liječenja lijekom Brineura, Vama ili Vašem djetetu mogu se javiti problemi s usađenim pomagalom (vidjeti dio 4 „Moguće nuspojave“), uključujući infekciju ili grešku pomagala.
English: Each ml of solution for infusion contains 30 mg of cerliponase alfa.
Croatian: Jedan ml otopine za infuziju sadrži 30 mg cerliponaze alfa.
English: These adverse reactions were observed during or within 24 hours after completion of the Brineura infusion and did not interfere with treatment.
Croatian: Te nuspojave bile su opažene tijekom ili unutar 24 sata nakon završene infuzije lijeka
English: Figure 2: CLN2 Score Mean Change from Baseline (Natural History Control Group vs Brineura treated patients, 300 mg every other week)
Croatian: Slika 2: Srednja vrijednost promjene rezultata za CLN2 u odnosu na početni rezultat (kontrolna skupina s prirodnim tijekom bolesti naspram bolesnika liječenih lijekom Brineura, 300 mg svaki drugi tjedan)
English: The access devices were replaced and patients resumed treatment with Brineura.
Croatian: Pomagala za pristup zamijenjena su i bolesnici su nastavili liječenje lijekom Brineura.
English: Meningitis may present with the following symptoms: fever, headache, neck stiffness, light sensitivity, nausea, vomiting, and change in mental status.
Croatian: Meningitis može imati sljedeće simptome: vrućicu, glavobolju, ukočenost u vratu, osjetljivost na svjetlost, mučninu, povraćanje i promjenu mentalnog stanja.
English: An ongoing study provides experience with two patients aged 2 years of age treated with Brineura at 300 mg every other week (see section 5.1).
Croatian: Iskustvo s dva bolesnika u dobi od 2 godine liječenih lijekom Brineura u dozi od 300 mg svaki drugi tjedan pruženo je ispitivanjem koje je u tijeku (vidjeti dio 5.1).
English: Brineura 150 mg solution for infusion
Croatian: Brineura 150 mg otopina za infuziju
English: Rate of Decline (points/48 weeks)a Overall (n = 23)
Croatian: Brzina propadanja funkcija (bodovi/48 tjedana)a
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN
English: Brineura and flushing solution are supplied and stored frozen (see section 6.4).
Croatian: Brineura i otopina za ispiranje dostavljaju se i čuvaju zamrznute (vidjeti dio 6.4).
English: In people with CLN2 disease, these materials build-up in certain parts of the body, mainly the brain.
Croatian: do takvog nakupljanja dolazi u određenim dijelovima tijela, uglavnom u mozgu.
English: This medicinal product contains 44 mg sodium per vial of Brineura and flushing solution.
Croatian: Ovaj lijek sadrži 44 mg natrija po bočici lijeka Brineura i otopine za ispiranje.
English: Very common side effects: headache increased or decreased protein in the brain fluid abnormal results of heart electrical activity (ECG) increased cells in the spinal fluid detected by laboratory monitoring infection of your nose or throat (cold) needle issue (infusion needle falls out of implanted device)
Croatian: glavobolja povišena ili snižena razina proteina u tekućini mozga poremećeni rezultati električne aktivnosti srca (EKG) povećan broj stanica u tekućini moždine (spinalni likvor) uočenih laboratorijskim praćenjem infekcija nosa ili grla (prehlada)
English: In-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Vrijeme i uvjeti čuvanja lijeka u primjeni prije uporabe odgovornost su korisnika.
English: Brineura treatment should be interrupted in cases of device failure and may require replacement of the access device prior to subsequent infusions.
Croatian: Terapiju lijekom Brineura treba prekinuti u slučajevima kvara pomagala, što može zahtijevati zamjenu pomagala prije daljnjih infuzija.
English: Healthcare professionals should be aware of the possible symptoms of anaphylaxis such as: generalized hives, pruritus or flushing, swollen lips, tongue, and/or uvula, dyspnoea, bronchospasm, stridor, hypoxemia, hypotonia, syncope, or incontinence.
Croatian: Zdravstveni radnici moraju biti upoznati s mogućim simptomima anafilaksije, kao što su generalizirana urtikarija, pruritus ili navale crvenila, otečene usne, jezik i/ili nepčana resica, dispneja, bronhospazam, stridor, hipoksemija, hipotonija, sinkopa ili inkontinencija.
English: If anaphylaxis occurs, caution should be exercised upon re-administration.
Croatian: Ako se pojavi anafilaksija, pri ponovnoj primjeni potrebno je postupati s oprezom.
English: Following Brineura infusion, a calculated amount of flushing solution must be used to flush the infusion components including the intracerebroventricular access device in order to fully administer Brineura and to maintain patency of the intracerebroventricular access device (see section 6.6).
Croatian: Nakon infuzije lijeka Brineura, komponente infuzijskog sustava se moraju isprati izračunatom količinom otopine za ispiranje, uključujući pomagalo za intracerebroventrikularni pristup, kako bi se primijenila cijela količina lijeka Brineura i održala prohodnost pomagala za intracerebroventrikularni pristup (vidjeti dio 6.6).
English: It is used to treat patients with neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase-1 (TPP1) deficiency.
Croatian: Upotrebljava se za liječenje bolesnika s neuronalnom ceroidnom lipofuscinozom tip 2 (CLN2), bolešću poznatom i kao nedostatak tripeptidil-peptidaze 1 (TPP1).
English: Using aseptic technique, withdraw the appropriate amount of flushing solution from the vial into the new sterile syringe labelled “flushing solution”.
Croatian: Primjenom aseptične tehnike uvucite iz bočice odgovarajući volumen otopine za ispiranje u novu sterilnu štrcaljku s oznakom „otopina za ispiranje“.
English: - If you or your child currently has signs of a device infection or problems with the device.
Croatian: - Ako Vi ili Vaše dijete sada imate znakove infekcije povezane s pomagalom ili pomagalo ima grešku.
English: Brineura is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.
Croatian: Lijek Brineura indiciran je za liječenje neuronalne ceroidne lipofuscinoze tipa 2 (CLN2), bolesti poznate i kao nedostatak tripeptidil-peptidaze 1 (TPP1).
English: Caution should be taken in patients prone to complications from intracerebroventricular medicinal product administration, including patients with obstructive hydrocephalus.
Croatian: Potrebno je postupati s oprezom u bolesnika sklonih komplikacijama izazvanih primjenom lijeka intracerebroventrikularnim putem, uključujući bolesnike s opstruktivnim hidrocefalusom.
English: For instructions on preparation of Brineura and flushing solution before administration, see section 6.6.
Croatian: Za upute o pripremi lijeka Brineura i otopine za ispiranje prije primjene vidjeti dio 6.6.
English: MRI volumetry measurements show attenuated rate of loss.
Croatian: Volumetrijska mjerenja provedena oslikavanjem magnetskom rezonancijom pokazuju smanjenu brzinu propadanja.
English: They are also responsible for disposing of any unused Brineura properly.
Croatian: Oni su odgovorni i za pravilno zbrinjavanje neupotrijebljenog lijeka Brineura.
English: of all convulsion events were considered related to cerliponase alfa and ranged from mild to severe, CTCAE grade 1-4.
Croatian: Ukupno, 6% svih događaja konvulzije smatrali su se povezani s cerliponazom alfa i bili su u rasponu od blagih do teških, CTCAE stupanj 1-4.
English: Total convulsion events with a temporal relationship to cerliponase alfa administration was 17% and were mild to moderate, grade 1 to 2 in severity.
Croatian: Bilo je ukupno 17% događaja konvulzije vremenski povezanih s primjenom cerliponaze alfa, a bili su blagog do umjerenog intenziteta, 1. do 2. stupnja.
English: There was no apparent effect of serum or CSF ADA on the plasma or CSF pharmacokinetics, respectively.
Croatian: Nije bilo vidljivog učinka serumskih ili CSF ADA na farmakokinetiku u plazmi odnosno CSF-u.
English: Each vial of Brineura and flushing solution are intended for single use only.
Croatian: Svaka bočica lijeka Brineura i otopina za ispiranje namijenjene su samo za jednokratnu upotrebu.
English: Common side effects: pain rash hives head dropping (so that the chin drops towards the chest) stomach pain leakage of the device mouth or tongue blisters swelling or redness of the eyelid and the white part of the eye feeling nervous disorder of the stomach or intestines
Croatian: bol osip koprivnjača spuštena glava (tako da brada pada prema prsnom košu) bol u trbuhu propuštanje pomagala mjehurići u ustima ili na jeziku oticanje ili crvenilo očnih kapaka i bjeloočnice osjećaj nervoze poremećaj želuca ili crijeva.
English: Calculate the flush volume by adding the priming volume of all infusion components, including the intracerebroventricular access device.
Croatian: Volumen za ispiranje izračunajte zbrajanjem volumena koji je potreban da se ispune sve infuzijske komponente, uključujući pomagalo za intracerebroventrikularni pristup.
English: Do not use if the solutions are discoloured or if there is other foreign particulate matter in the solutions.
Croatian: Nemojte upotrijebiti otopine ako su promijenile boju ili ako su u njima prisutne druge strane čestice.
English: Limited preclinical safety data of cerliponase alfa were generated from single dose toxicity studies in monkeys and repeated-dose studies in a dachshund dog model of classic late infantile neuronal ceroid lipofuscinosis type 2.
Croatian: Ograničeni neklinički podaci o sigurnosti primjene cerliponaze alfa dobiveni su iz ispitivanja toksičnosti na modelu klasične kasne infantilne neuronalne ceroidne lipofuscinoze tip 2 u majmuna za jednokratnu dozu, a u pasa pasmine jazavčar za ponovljenu dozu.
English: Each domain encompasses scores of 3 (grossly normal) to 0 (profoundly impaired), for a total possible score of 6, with unit decrements representing milestone events in the loss of previously attained functions of ambulation and speech.
Croatian: Svaka domena obuhvaća rezultate od 3 (potpuno normalno) do 0 (duboko oštećeno), za ukupno mogući rezultat od 6,
English: Inspection of the infusion site and a patency check must be performed to detect intracerebroventricular access device leakage and/or failure prior to initiation of Brineura infusion (see section 4.2 and 4.3).
Croatian: Pregled mjesta infuzije i provjera prohodnosti moraju se provesti kako bi se propuštanje i/ili kvar pomagala za intracerebroventrikularni pristup otkrili prije započinjanja infuzije lijeka Brineura (vidjeti dio 4.2 i 4.3).
English: Brineura is administered to the cerebrospinal fluid (CSF) by infusion via a surgically implanted reservoir and catheter (intracerebroventricular access device).
Croatian: Brineura se u cerebrospinalni likvor (CSF) primjenjuje infuzijom pomoću kirurški implantiranog spremnika i katetera (pomagala za intracerebroventrikularni pristup).
English: Pack size of three vials: two 10 ml vials, each containing 150 mg of cerliponase alfa in 5 ml of solution; and one 10 ml vial, containing 5 ml flushing solution.
Croatian: Pakiranje od tri bočice: dvije bočice od 10 ml, svaka sadrži 150 mg cerliponaze alfa u 5 ml otopine i jedna bočica od 10 ml koja sadrži 5 ml otopine za ispiranje.
English: Brineura and the flushing solution must only be administered by the intracerebroventricular route.
Croatian: Brineura i otopina za ispiranje smiju se primijeniti samo intracerebroventrikularnim putem.
English: Apply gentle pressure and bandage the infusion site per institution standard of care.
Croatian: Blago pritisnite i gazom pokrijte mjesto primjene infuzije prema standardima skrbi ustanove.
English: Breastfeeding should be discontinued during treatment with Brineura.
Croatian: Dojenje se treba prekinuti za vrijeme liječenja lijekom Brineura.
English: The glycosylation profile of cerliponase alfa results in consistent cellular uptake and lysosomal targeting for activation.
Croatian: Profil glikolizacije cerliponaze alfa rezultira konzistentnim staničnim unosom te ciljanim prenosom u lizosome zbog aktivacije.
English: Brineura 150 mg solution for infusion cerliponase alfa
Croatian: Brineura 150 mg otopina za infuziju cerliponaza alfa
English: Discard the empty syringe in accordance with local requirements.
Croatian: Praznu štrcaljku bacite sukladno nacionalnim propisima.
English: Anaphylaxis has not been reported with Brineura use during clinical trials; however, the risk of anaphylaxis cannot be excluded.
Croatian: Tijekom kliničkih ispitivanja lijeka Brineura nije zabilježena anafilaksija; međutim, rizik od anafilaksije ne može se isključiti.
English: Open vials or product in syringes should be used immediately.
Croatian: Otvorene bočice ili lijek u štrcaljkama treba upotrijebiti odmah.
English: - The other ingredients of Brineura and the flushing solution are: sodium phosphate dibasic heptahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, potassium chloride, magnesium chloride hexahydrate, calcium chloride dihydrate, and water for injections (see section 2 “Brineura contains sodium”)
Croatian: - Drugi sastojci lijeka Brineura i otopine za ispiranje: natrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat hidrat, natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, kalcijev klorid dihidrat i voda za injekcije (vidjeti dio 2 „Brineura sadrži natrij“).
English: Common signs of device leakage and device failure include swelling, erythema of the scalp, extravasation of fluid, or bulging of the scalp around or above the intracerebroventricular access device.
Croatian: Uobičajeni znakovi propuštanja ili kvara pomagala uključuju oticanje, eritem vlasišta, ekstravazacija tekućine ili ispupčenja na vlasištu oko ili iznad pomagala za intracerebroventrikularni pristup.
English: Treatment of Brineura was initiated in children 2 to 8 years of age in clinical studies.
Croatian: U kliničkim ispitivanjima, liječenje lijekom Brineura započeto je u djece u dobi od 2 do 8 godina.
English: Age groups
Croatian: Dobne skupine
English: In case of intracerebroventricular access device-related complications, refer to the manufacturer's labelling for further instruction.
Croatian: U slučaju komplikacija povezanih s pomagalom za intracerebroventrikularni pristup, daljnje informacije potražite u proizvođačevim uputama za uporabu pomagala.
English: Store upright in a freezer (-25°C to -15°C).
Croatian: Čuvati u uspravnom položaju u zamrzivaču (od -25 °C do -15 °C).
English: Periodically inspect the infusion system during the infusion for signs of leakage or delivery failure.
Croatian: Redovito provjeravajte sustav tijekom infuzije zbog znakova propuštanja ili greške u protoku infuzije.
English: Device issue:
Croatian: Česte nuspojave:
English: Limited data are available for children aged 2 years and no clinical data is available in children below 2 years of age (see section 5.1).
Croatian: Dostupni su ograničeni podaci za djecu u dobi od 2 godine, a za djecu mlađu od 2 godine nema kliničkih podataka
English: Attach the syringe containing Brineura to the extension line, if used, otherwise connect the syringe to the infusion set.
Croatian: 2. Štrcaljku koja sadrži lijek Brineura pričvrstite na produžni dio infuzijske linije, ako se koristi, u protivnom štrcaljku spojite na komplet za infuziju.
English: As a precautionary measure, appropriate medical support should be readily available when Brineura is administered.
Croatian: Kao mjera opreza, kada se primjenjuje Brineura treba biti odmah dostupna odgovarajuća medicinska potpora.
English: CSF protein increased ECG abnormalities CSF protein decreased
Croatian: Pretrage povišeni proteini u CSF-u abnormalnosti EKG-a sniženi proteini u CSF-u vrlo često vrlo često vrlo često
English: The implanted intracerebroventricular access device should be appropriate for accessing the cerebral ventricles for therapeutic administration.
Croatian: Implantirano pomagalo za intracerebroventrikularni pristup treba omogućiti pristup do moždanih komora za primjenu terapije.
English: Pack size: 3 vials (two vials of Brineura and one vial of flushing solution), each containing 5 ml of solution
Croatian: Veličina pakiranja: 3 bočice (dvije bočice lijeka Brineura i jedna bočica otopine za ispiranje), svaka sadrži 5 ml otopine.
English: • One single-use infusion set.
Croatian: • Jedan komplet za infuziju za jednokratnu uporabu.
English: Tabulated list of adverse reactions Adverse reactions observed are listed below, by system organ class and frequency, following the MedDRA
Croatian: Tablični popis nuspojava Opažene nuspojave navedene su u nastavku prema klasifikaciji organskih sustava i u skladu s
English: Each vial contains 44 mg of sodium.
Croatian: Jedna bočica sadrži 44 mg natrija.
English: Brineura must only be administered by a trained healthcare professional knowledgeable in intracerebroventricular administration in a healthcare setting.
Croatian: Lijek Brineura smiju primjenjivati samo osposobljeni zdravstveni radnici educirani za intracerebroventrikularnu primjenu u kliničkim/bolničkim uvjetima.
English: Cerliponase alfa is taken up by target cells and translocated to the lysosomes through the Cation Independent Mannose-6-Phosphate Receptor (CI-MPR, also known as M6P/IGF2 receptor).
Croatian: Cation Independent Mannose-6-Phosphate Receptor, CI-MPR, poznatog i kao receptor M6P/IGF2).
English: Intelligible and grossly age-appropriate.
Croatian: Razumljiv i potpuno primjeren dobi.
English: Vial (type I glass) with a stopper (butyl rubber), a flip-off cap (polypropylene) and crimp seal (aluminium).
Croatian: Bočica (staklo tip I) s čepom (butilna guma), kapicom (polipropilen) i aluminijskim prstenom.
English: Intracerebroventricular use.
Croatian: Intracerebroventrikularna primjena.
English: Your doctor or pharmacist is responsible for storing Brineura.
Croatian: Za čuvanje lijeka Brineura odgovoran je Vaš liječnik ili ljekarnik.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva osip urtikarija često često
English: Post-authorisation efficacy study (PAES): Study 190-203.
Croatian: (PAES): ispitivanje 190-203.
English: Do not shake vials.
Croatian: Ne tresite bočice.
English: Attach the infusion set to the port needle (see Figure 1).
Croatian: 8. Pričvrstite komplet za infuziju na ulaznu iglu (vidjeti sliku 1).