FrancophonIA/ELRC3.0 huggingface dataset:
English: It is not known if Brineura impacts human fertility.
Croatian: Nije poznato utječe li Brineura na plodnost.
English: How Brineura works
Croatian: Kako Brineura djeluje
English: Treatment effect in patients receiving Brineura was assessed using the CLN2 clinical rating scale, and results were compared to the 2 points per 48 weeks predicted decline in the natural history control group.
Croatian: Učinak liječenja u bolesnika koji su primali lijek Brineura procijenjen je kliničkom ljestvicom za ocjenu bolesti CLN2, a rezultati su uspoređeni s predviđenim gubitkom funkcija u kontrolnoj skupini s prirodnim tijekom bolesti tj. smanjenjem za 2 boda po periodu od 48 tjedana.
English: Brineura vials may occasionally contain thin translucent fibres or opaque particles.
Croatian: Bočice s lijekom Brineura mogu katkad sadržavati tanka prozirna vlakna ili neprozirne čestice.
English: Domain Score
Croatian: Domena Rezultat
English: Thaw Brineura vials and flushing solution vial at room temperature for approximately 60 minutes.
Croatian: Odmrznite lijek Brineura i otopinu za ispiranje Bočice lijeka Brineura i otopine za ispiranje odmrzavajte na sobnoj temperature otprilike 60 minuta.
English: CSF samples should routinely be sent for testing to detect subclinical device infections (see section 4.2).
Croatian: Uzorke CSF-a treba svaki put poslati na testiranje kako bi se otkrile supkliničke infekcije povezane s pomagalom (vidjeti dio 4.2).
English: There is limited experience in a few patients aged 2 years old.
Croatian: Ograničeno je iskustvo s primjenom u malobrojnih bolesnika u dobi od
English: Healthcare professionals should inspect the scalp for skin integrity to ensure the intracerebroventricular access device is not compromised prior to each infusion.
Croatian: Prije svake infuzije zdravstveni radnici trebaju pregledati vlasište zbog provjere postojanja oštećenja kože, kako bi se osiguralo da pomagalo za intracerebroventrikularni pristup nije ugroženo.
English: The solutions are clear to slightly opalescent, colourless to pale yellow; the Brineura solution may occasionally contain thin translucent fibres or opaque particles.
Croatian: Otopine su bistre do lagano opalescentne i bezbojne do blijedožute; otopina lijeka Brineura može katkad sadržavati tanka prozirna vlakna ili neprozirne čestice.
English: No studies on the effect of Brineura on the ability to drive or use machines have been performed.
Croatian: Nisu provedena ispitivanja o učinku lijeka Brineura na sposobnost upravljanja vozilima i rada sa strojevima.
English: Brineura and flushing solution should be clear to slightly opalescent and colourless to pale yellow.
Croatian: Brineura i otopina za ispiranje moraju biti bistre do lagano opalescentne te bezbojne do blijedožute boje.
English: CSF samples should routinely be sent for testing to detect subclinical device infections.
Croatian: Uzorke CSF-a treba svaki put poslati na testiranje kako bi se otkrile supkliničke infekcije povezane s pomagalom.
English: Brineura must not be administered as long as there are signs of acute intracerebroventricular access device leakage, device failure, or device-related infection (see section 4.2 and 4.4).
Croatian: Brineura se ne smije primjenjivati sve dok ima znakova akutnog propuštanja pomagala za intracerebroventrikularni pristup, kvara pomagala ili infekcije povezane s pomagalom (vidjeti dio 4.2 i
English: Intracerebroventricular Infusion of Brineura
Croatian: Intracerebroventrikularna infuzija lijeka Brineura
English: Vertical bars represent standard error of the mean Solid line: 190-201 and 190-202 clinical studies Dash line: 190-901 Natural history control group
Croatian: Okomiti stupci prikazuju standardnu grešku prosjeka Puna crta: kliničko ispitivanje 190-201 i 190-202
English: Label one unused sterile syringe “flushing solution” and attach a syringe needle.
Croatian: Obilježite jednu neupotrijebljenu sterilnu štrcaljku oznakom „otopina za ispiranje“ i na nju pričvrstite iglu za štrcaljku.
English: Determine the volume of flushing solution needed to ensure complete delivery of Brineura to the cerebral ventricles.
Croatian: Odredite volumen otopine za ispiranje potreban kako bi se osiguralo da će cijela količina lijeka Brineura dospjeti u moždane komore.
English: Each vial of Brineura contains 150 mg cerliponase alfa in 5 ml of solution (30 mg/ml)
Croatian: Jedna bočica lijeka Brineura sadrži 150 mg cerliponaze alfa u 5 ml otopine (30 mg/ml)
English: If you or your child gets any side effects, talk to your doctor.
Croatian: Ako Vi ili Vaše dijete primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
English: Currently no clinical experience of Brineura in children below 2 years of age is available.
Croatian: Trenutačno nema kliničkog iskustva s lijekom Brineura u djece mlađe od 2 godine.
English: How to store Brineura
Croatian: Kako primjenjivati lijek Brineura
English: Place the syringe containing Brineura into the syringe pump and program the pump to deliver at an infusion rate of 2.5 ml per hour.
Croatian: Stavite štrcaljku s lijekom Brineura u pumpu za štrcaljku i programirajte pumpu na brzinu infuzije od 2,5 ml na sat.
English: - If you or your child gets any side effects, talk to your doctor.
Croatian: - Ako Vi ili Vaše dijete primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
English: Insert the port needle into the intracerebroventricular access device.
Croatian: 6. Umetnite ulaznu iglu (engl. port needle) u pomagalo za intracerebroventrikularni pristup.
English: Animal reproduction studies have not been conducted using Brineura.
Croatian: S lijekom Brineura nisu provedena ispitivanja reprodukcije u životinja.
English: Do not administer Brineura if there are signs and symptoms of acute intracerebroventricular access device leakage, device failure, or device-related infection (see section 4.3 and 4.4).
Croatian: Nemojte primjenjivati lijek Brineura u slučaju znakova i simptoma propuštanja pomagala za intracerebroventrikularni pristup, kvara pomagala ili infekcije povezane s pomagalom (vidjeti dio 4.3 i 4.4).
English: Thawed Brineura and flushing solution should be used immediately.
Croatian: Otopljeni lijek Brineura i otopina za ispiranje trebaju se odmah upotrijebiti.
English: Each vial contains 44 mg of sodium in 5 ml of solution.
Croatian: Jedna bočica sadrži 44 mg natrija u 5 ml otopine.
English: Label one unused sterile syringe “Brineura” and attach a syringe needle.
Croatian: Jednu neupotrijebljenu sterilnu štrcaljku označite s „Brineura“ i pričvrstite na nju iglu za štrcaljku.
English: Discard the needle and empty vials per local requirements.
Croatian: Iglu i prazne bočice bacite sukladno nacionalnim propisima.
English: Initiate infusion of Brineura at a rate of 2.5 ml per hour.
Croatian: Započnite infuziju lijeka Brineura brzinom od 2,5 ml na sat.
English: Discard the needle and the vial with the remaining solution per local requirements.
Croatian: Iglu i bočicu s preostalom otopinom bacite sukladno nacionalnim propisima.
English: Intracerebroventricular use
Croatian: Intracerebroventrikularna primjena
English: Clear to slightly opalescent and colourless to pale yellow solution, that may occasionally contain thin translucent fibres or opaque particles.
Croatian: Otopina je bistra do lagano opalescentna i bezbojna do blijedožuta, koja povremeno može sadržavati tanka prozirna vlakna ili neprozirne čestice.
English: Device-related complications
Croatian: Komplikacije povezane s pomagalom
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Brineura Lijek čuvajte izvan pogleda i dohvata djece.
English: Solution for infusion Two vials of Brineura One vial of flushing solution
Croatian: Dvije bočice lijeka Brineura Jedna bočica otopine za ispiranje
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Sjedinjene Američke Države Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: The most frequent (>20%) adverse reactions observed during Brineura clinical trials include pyrexia, low CSF protein, ECG abnormalities, vomiting, upper respiratory tract infections, and hypersensitivity.
Croatian: Najčešće nuspojave (> 20%) opažene s lijekom Brineura u kliničkim ispitivanjima uključuju pireksiju, nisku razinu proteina u
English: Anti-drug antibodies (ADAs) were detected in both serum and CSF in 79% and 21%, respectively, of patients treated with cerliponase alfa for up to 107 weeks.
Croatian: Protutijela protiv lijeka (engl. anti-drug antibodies, ADA) ustanovljeni su i u serumu i u CSF-u u 79%
English: Inspect the scalp for signs of intracerebroventricular access device leakage or failure and for potential infections.
Croatian: 4. Provjerite vlasište zbog znakova propuštanja ili kvara pomagala za intracerebroventrikularni pristup te moguće infekcije.
English: All pharmacokinetic parameters were similar following the initial infusion on Day 1 and following infusions at Week 5 and Week 13, indicating no apparent accumulation or time dependent PK of cerliponase alfa in CSF or plasma when administered at of dose of 300 mg once every other week.
Croatian: 13. tjednu, što nije ukazivalo na vidljivu akumulaciju ili vremenski ovisnu farmakokinetiku cerliponaze alfa u CSF-u ili plazmi kada se primjenjivala u dozi od 300 mg jednom svaki drugi tjedan.
English: Brineura and the flushing solution are solutions for infusion.
Croatian: Brineura i otopina za ispiranje otopine su za infuziju.
English: Flushing solution for Brineura Intracerebroventricular use
Croatian: Otopina za ispiranje za lijek Brineura Intracerebroventrikularna primjena
English: The MAH shall ensure that in each MS where BRINEURA is marketed, all HCPs who are expected to handle / administer the product are provided with an educational programme (i.e. a dosing and administration guide), aiming at preventing and/or minimising the important identified risk of Device issues (infection/blockage/dislocation), containing information about: - How to store BRINEURA; - The device-related complications (i.e. infections, device's leakage and/or failure; the integrity of the device should be confirmed by a neurosurgeon); - How to prepare BRINEURA and the flushing solution; - A detailed step-by step description of BRINEURA intra-cerebro-ventricular infusion and the administration of the flushing solution (provided after BRINEURA infusion is complete) - How to monitor the patients receiving BRINEURA.
Croatian: - komplikacije povezane s pomagalom (tj. infekcije, propuštanje pomagala i/ili greška; cjelovitost pomagala treba potvrditi neurokirug); - kako pripremiti lijek BRINEURA i otopinu za ispiranje; - detaljni opis, korak po korak, intracerebroventrikularne infuzije lijeka BRINEURA i primjene otopine za ispiranje (nakon završene infuzije lijeka BRINEURA); - kako nadzirati bolesnika koji prima lijek BRINEURA.
English: Not known (frequency cannot be estimated based on available data) device is displaced and does not function correctly when preparing for infusion inflammation of the brain due to device-related infection
Croatian: pomagalo je pomjereno te ne funkcionira na ispravan način kod pripreme za infuziju upala mozga uzrokovana infekcijom povezanom s pomagalom
English: The large CSF to plasma ratios in Cmax and AUC0-t (approximately 1000 and 400, respectively) suggest that the majority of administered cerliponase alfa remains localized within the CNS.
Croatian: Veliki omjeri CSF-a i plazme u vrijednostima Cmax i AUC0-t (približno 1000 odnosno 400)
English: Prime the infusion components with Brineura.
Croatian: 3. Napunite infuzijske linije lijekom Brineura.
English: Brineura and flushing solution Sodium phosphate dibasic heptahydrate Sodium dihydrogen phosphate monohydrate Sodium chloride
Croatian: Brineura i otopina za ispiranje natrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat hidrat natrijev klorid kalijev klorid magnezijev klorid heksahidrat kalcijev klorid dihidrat voda za injekcije
English: Talk to your doctor or nurse immediately if you experience any of the following:
Croatian: Odmah obavijestite liječnika ili medicinsku sestru ako Vam se pojavi nešto od sljedećeg: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba):
English: Life-threatening allergic reactions are possible with Brineura.
Croatian: Uz lijek Brineura moguće su po život opasne alergijske reakcije.
English: Remove the yellow flip-off cap from the flushing solution vial.
Croatian: Uklonite žutu kapicu s bočice otopine za ispiranje.
English: Store upright in a freezer (-20°C ± 5°C).
Croatian: POSEBNE MJERE ČUVANJA Čuvati u zamrzivaču u uspravnom položaju (-20 °C ± 5 °C).
English: Very common side effects (may affect more than 1 in 10 people): fever vomiting feeling irritable convulsions (seizures) reactions during or shortly after being given the medicine, such as hives, itching or flushing, swollen lips, tongue and/or throat, shortness of breath, hoarseness, turning blue around finger tips or lips, low muscle tone, fainting or incontinence
Croatian: vrućica povraćanje osjećaj razdražljivosti konvulzije (napadaji) reakcije za vrijeme ili ubrzo nakon primanja lijeka, kao što su koprivnjača, svrbež ili naleti crvenila, otečene usne, jezik i/ili grlo, nedostatak zraka, promuklost, plava boja na vrhovima prstiju ruku ili oko usana, nizak tonus (napetost) mišića, nesvjestica i nemogućnost zadržavanja mokraće (inkontinencija).
English: Common Common Not known Very common a Propionibacterium acnes, staphylococcus epidermis b Atonic seizures, clonic convulsion, drop attacks, epilepsy, generalised tonic-clonic seizure, myoclonic epilepsy, partial seizures, petit mal epilepsy, seizure, seizure cluster, and status epilepticus c Pyrexia includes combined preferred terms “Pyrexia” and “Increased body temperature” d Catheter flow obstruction e Device dislocation did not occur in clinical trials f Dislodgement of infusion needle
Croatian: parcijalni napadaji, petit mal epilepsija, napadaj, klaster napadaja i epileptički status c Pireksija uključuje kombinirane preporučene pojmove „pireksija“ i „povišena tjelesna temperatura“
English: You or your child will need to have surgery to implant the device for giving Brineura.
Croatian: Za primjenu lijeka Brineura, Vama ili Vašem djetetu bit će potrebno kirurškim postupkom usaditi pomagalo koji pomaže da lijek dospije do određenog dijela mozga.
English: The following components (not supplied) are required for proper administration of Brineura and flushing solution (see Figure 1 in section 4.2).
Croatian: Za pravilnu primjenu lijeka Brineura i otopine za ispiranje potrebne su sljedeće komponente (nisu priložene) (vidjeti sliku 1 u dijelu 4.2).
English: The following CE marked disposable infusion components were used in Brineura clinical trials:
Croatian: U kliničkim ispitivanjima lijeka Brineura, upotrijebljene su sljedeće infuzijske komponente za jednokratnu uporabu, oznake CE:
English: Symptoms resolved over time or with administration of antipyretics, antihistamines and/or glucocorticosteroids.
Croatian: antihistaminika i/ili glukokortikosteroida.
English: Package leaflet: Information for the user Brineura 150 mg solution for infusion cerliponase alfa This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Brineura 150 mg otopina za infuziju cerliponaza alfa
English: Verify that the “Brineura” syringe in the syringe pump is empty after the infusion is complete.
Croatian: 12. Kada je infuzija završila, provjerite je li štrcaljka „Brineura“ u pumpi prazna.
English: This should be taken into consideration for patients on a controlled sodium diet.
Croatian: O tome treba voditi računa u bolesnika na prehrani s ograničenjem unosa natrija.
English: Initiate infusion of the flushing solution at a rate of 2.5 ml per hour.
Croatian: 3. Započnite infuziju otopine za ispiranje brzinom od 2,5 ml na sat.
English: Table 2: Frequency of adverse reactions with Brineura
Croatian: Tablica 2: Učestalost nuspojava lijeka Brineura
English: MedDRA Preferred term
Croatian: preporučeni pojam
English: Access device replacement should be considered prior to 4 years of regular administration of Brineura, however it must always be ensured, that the intracerebroventricular access device is used in accordance with the provisions of the respective medical device manufacturer.
Croatian: Zamjenu pomagala za pristup treba razmotriti prije isteka 4 godine redovite primjene lijeka Brineura,
English: Signs that you or your child may have an infection include fever, headache, neck stiffness, light sensitivity, nausea, vomiting, and change in mental status.
Croatian: glavobolju, ukočenost u vratu, osjetljivost na svjetlost, mučninu, povraćanje i promjenu mentalnog stanja.
English: Verify that the “flushing solution” syringe in the syringe pump is empty after the infusion is complete.
Croatian: 5. Kada infuzija završi, provjerite je li štrcaljka s oznakom „otopina za ispiranje“ u pumpi prazna.
English: Withdraw flushing solution
Croatian: Izvucite otopinu za ispiranje
English: Very common Common
Croatian: Potpuno normalan hod.
English: Each vial of Brineura contains 150 mg of cerliponase alfa in 5 ml of solution.
Croatian: Jedna bočica lijeka Brineura sadrži 150 mg cerliponaze alfa u 5 ml otopine.
English: Preparation for administration of Brineura and flushing solution
Croatian: Priprema za primjenu lijeka Brineura i otopine za ispiranje
English: Remove the port needle.
Croatian: 6. Izvucite ulaznu iglu.
English: The infusion rate for Brineura and the flushing solution is 2.5 ml/hour.
Croatian: Brineura i otopina za ispiranje daju se brzinom infuzije od 2,5 ml/h.
English: Your doctor will monitor you or your child for symptoms of life threatening allergic reactions, such as hives, itching or flushing, swollen lips, tongue, and/or throat, shortness of breath, hoarseness, turning blue around finger tips or lips, low muscle tone, fainting or incontinence.
Croatian: svrbež ili naleti crvenila, otečene usne, jezik i/ili grlo, nedostatak zraka, promuklost, plava boja na vrhovima prstiju ruku ili oko usana, nizak tonus mišića, nesvjestica ili nemogućnost zadržavanja mokraće (inkontinencija).
English: CE marked intracerebroventricular access devices, and disposable components listed below or equivalent should be used to deliver Brineura.
Croatian: Za primjenu lijeka Brineura potrebno je upotrijebiti pomagala za intracerebroventrikularni pristup i u nastavku navedene komponente za jednokratnu primjenu ili njihove ekvivalente, oboje s oznakom CE.
English: Brineura and flushing solution excipients: Sodium phosphate dibasic heptahydrate; Sodium dihydrogen phosphate monohydrate; Sodium chloride;
Croatian: Pomoćne tvari lijeka Brineura i otopine za ispiranje: natrijev hidrogenfosfat heptahidrat; natrijev dihidrogenfosfat hidrat; natrijev klorid; kalijev klorid; magnezijev klorid heksahidrat; kalcijev klorid dihidrat; voda za injekcije
English: Common
Croatian: Ukupno
English: Thaw before use.
Croatian: Odmrznuti prije primjene.
English: Water for injections;
Croatian: Otopina za infuziju
English: Each vial of Brineura contains 150 mg of cerliponase alfa* in 5 ml of solution.
Croatian: Jedna bočica lijeka Brineura sadrži 150 mg cerliponaze alfa* u 5 ml otopine.
English: Administer flushing solution after Brineura.
Croatian: Otopinu za ispiranje primijeniti nakon lijeka Brineura.
English: Administer the flushing solution provided after the Brineura infusion is complete.
Croatian: Intracerebroventrikularna infuzija otopine za ispiranje Predviđenu otopinu za ispiranje primijenite nakon završene infuzije lijeka Brineura.
English: Signs of problems with the device include swelling, redness of the scalp, fluid leaking from device and bulging of the scalp.
Croatian: Znakovi problema s pomagalom uključuju: oticanje, crvenilo vlasišta,
English: Cardiac disorders
Croatian: Srčani poremećaji bradikardija često
English: Refer to the intracerebroventricular access device manufacturer's recommendation for the port needle.
Croatian: Za preporuke o ulaznoj igli pogledati preporuke proizvođača pomagala za intracerebroventrikularni pristup.
English: Median Min, Max 95% CI Limits a Patient rate of decline per 48 weeks: (baseline CLN2 score - last CLN2 score) / (time elapsed in units of 48 weeks) b p-value based on 1-sample T-test comparing rate of decline to the value 2 c Positive estimates indicate clinical decline; negative estimates indicate clinical improvement
Croatian: a Brzina propadanja funkcije u bolesnika u 48 tjedana: (početni rezultat za CLN2 - posljednji rezultat za CLN2) / (vrijeme koje je prošlo u jedinicama od 48 tjedana).
English: • A 0.2 µm inline filter is required.
Croatian: • Potreban je ugrađeni filtar pora veličine 0,2 µm, koji može biti i sastavni dio kompleta za infuziju.
English: Rating
Croatian: Ocjena
English: Inspect the vials to ensure they are fully thawed.
Croatian: Pregledajte bočice odmrznutog lijeka Brineura i otopine za ispiranje Bočice pregledajte kako biste provjerili jesu li potpuno odmrznute.
English: Administer Brineura before flushing solution.
Croatian: Lijek Brineura primijeniti prije otopine za ispiranje.
English: Abdominal pain Oral mucosal blistering Tongue blistering Gastrointestinal disorder
Croatian: Poremećaji probavnog sustava povraćanje abdominalni bol mjehurići na sluznici usta mjehurići na jeziku poremećaj probavnog sustava vrlo često često često često često
English: Product issues
Croatian: FARMACEUTSKI PODACI
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava preosjetljivost vrlo često
English: United States
Croatian: DJECE
English: Posology
Croatian: BOČICA
English: Bradycardia
Croatian: GmbH
English: This is further supported by the likely common mechanism of action.
Croatian: To je dodatno potvrđeno vjerojatnim zajedničkim mehanizmom djelovanja.
English: The exposure to these substances is respectively estimated to 565,000 patient-years, 555,470 patient-years and 66,052 patient-years worldwide.
Croatian: Procjenjuje se da te tvari godišnje upotrebljava redom 565 000, 555 470 i 66 052 pacijenata diljem svijeta.
English: Further, in a number of cases, blood glucose values were only moderately increased or normal.
Croatian: Nadalje, u nekoliko su slučajeva vrijednosti glukoze u krvi bile umjereno povećane ili normalne.
English: A safety warning on DKA was issued by the FDA for this therapeutic class in the same month.
Croatian: FDA je u istom mjesecu izdala sigurnosno upozorenje u vezi s DKA-om za taj terapijski razred.
English: Although the MAHs estimated slightly different incidence rates, these were not all calculated according to the international standards for computation of incidence rate.
Croatian: Iako su nositelji odobrenja ocijenili da postoje malo drugačije stope pojave, one nisu sve izračunate u skladu s međunarodnim standardima za izračun stope pojave.
English: Based on the data available, the PRAC considered that there was no indication of a different risk between the products.
Croatian: Na temelju dostupnih podataka, PRAC je zaključio da ništa ne upućuje na drugačije rizike među lijekovima.
English: A search in Eudravigilance (EV) database was performed by the EMA on 19 May 2015 for the three SGLT2 inhibitors.
Croatian: EMA je 19. svibnja 2015. pretražila bazu podataka Eudravigilance (EV) za ta tri SGLT2 inhibitora.
English: No definite conclusion could be drawn regarding dose relationship or protective or exacerbating effect of concomitant medicines.
Croatian: Ne može se izvesti nikakav konačan zaključak u pogledu povezanosti s dozom ili pak zaštitnog učinka ili učinka pogoršanja stanja od istodobne uporabe lijekova.
English: This can be partially buffered with the bicarbonate buffering system, but this system is quickly overwhelmed and other mechanisms must work to compensate for the acidosis.
Croatian: To se može djelomično ublažiti bikarbonatnim puferskim sustavom, no taj sustav brzo postaje preopterećen pa drugi mehanizmi moraju djelovati ne bi li nadoknadili acidozu.
English: In addition treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses.
Croatian: Usto bi liječenje trebalo prekinuti kod pacijenata koji su hospitalizirani zbog velikog operativnog zahvata ili ozbiljne akutne bolesti.