FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advise before you are given this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se liječniku specijalistu nuklearne medicine za savjet prije nego primite ovaj lijek.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije te toksičnosti i genotoksičnosti jednokratnih i ponovljenih doza.
English: In vitro studies using human liver microsomes did not indicate any potential to inhibit the cytochrome P450 enzyme system.
Croatian: In vitro ispitivanja s mikrosomima ljudske jetre ne ukazuju na bilo kakav potencijal inhibicije citokrom P450 enzimskog sustava.
English: Fluorine (18F) has a physical half-life of 110 minutes.
Croatian: Fluor (18F) ima fizički poluvijek od 110 minuta.
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority.
Croatian: Prije puštanja lijeka u promet u svakoj državi članici nositelj odobrenja će usuglasiti konačni obrazovni program s nadležnim nacionalnim tijelom.
English: A brain scan is usually taken 90 minutes after Neuraceq is given.
Croatian: Oslikavanje mozga provodi se obično 90 minuta nakon primjene Neuraceqa.
English: - if you are allergic to florbetaben (18F) or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na florbetaben (18F) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: At 12 hours post injection 98.93% of the activity is decayed, at 24 hours post injection 99.99 % of the activity is decayed.
Croatian: Dvanaest sati nakon injekcije 98,93 % aktivnosti se raspada, a 24 sati nakon injekcije 99,99 % aktivnosti je raspadnuto.
English: Neuraceq has no influence on the ability to drive and use machines.
Croatian: Neuraceq ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: This is equivalent to 1.6% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 1,6 % preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: Residual activity in the midsagittal sinus can be sometimes observed likely due to the presence of tracer in the blood pool.
Croatian: Rezidualna aktivnost u sagitalnom sinusu može se ponekad opaziti najvjerojatnije zbog prisustva obilježivača u krvi.
English: Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines since they may interfere with the interpretation of the images from the PET scan.
Croatian: Obavijestite svog liječnika nuklearne medicine ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove jer oni mogu ometati tumačenje snimaka PET snimanja.
English: Inter-rater agreement using Fleiss' kappa values ranged from 0.68 to 0.87.
Croatian: Fleissove kappa vrijednosti kretale su se u rasponu od 0,68 do 0,87.
English: DATE OF REVISION OF THE TEXT 11.
Croatian: DATUM REVIZIJE TEKSTA 11. DOZIMETRIJA
English: Paediatric population There is no relevant use of Neuraceq in the paediatric population.
Croatian: Pedijatrijska populacija Nema relevantne primjene Neuraceqa u pedijatrijskoj populaciji.
English: The overall safety profile of Neuraceq is based on data from 1,295 administrations of Neuraceq to 1,077 subjects and 12 subjects who received vehicle.
Croatian: Općeniti sigurnosni profil temelji se na podacima dobivenim iz 1295 primjena Neurceqa u 1077 ispitanika i 12 ispitanika koji su primili nosač.
English: February 2014 Date of latest renewal: 20.
Croatian: Datum prvog odobrenja: 20. veljače 2014 Datum obnove odobrenja: 20. studeni 2018
English: For each patient, the radiation exposure must be justified by the likely benefit.
Croatian: Za svakog se bolesnika izlaganje zračenju mora opravdati vjerojatnom korišću.
English: RCTU score 2 in any or all of the 4 brain regions and no score 3 in these 4 brain regions
Croatian: RCTU ocjena 2 u bilo kojem ili u sva 4 područja mozga i bez ocjene 3 u ta 4 područjamozga
English: METALLIC BOX (with Blue Box)
Croatian: METALNA KUTIJA (s plavim okvirom)
English: The following information is intended for medical or healthcare professionals only.
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima:
English: The reason for this accumulation is unknown, but maybe due to accumulation of florbetaben (18F) or to any of its radioactive metabolites, or to blood radioactivity.
Croatian: Razlozi zbog kojih dolazi do tog nakupljanja nisu poznati, no moguće je da je to posljedica akumulacije florbetabena (18F), nekog od njegovih radioaktivnih metabolita ili radioaktivnosti u krvi.
English: In radioligand binding assays using a broad panel of animal and human receptors, ion channels and transporters no significant binding was found.
Croatian: Ispitivanja vezivanja radioliganda, koristeći širok spektar životinjskih i ljudskih receptora, ionskih kanala i transportera, nisu pokazala značajno vezivanje.
English: Other medicines and Neuraceq
Croatian: Drugi lijekovi i Neuraceq
English: Dose absorbed per activity administered [mGy/MBq]
Croatian: Apsorbirana doza po primijenjenoj aktivnosti [mGy/MBq]
English: The adverse reactions are ranked under heading of frequency using the following convention: 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: Nuspojave su rangirane prema naslovu učestalosti primjenom sljedeće konvencije: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko
English: The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information.
Croatian: U svakom se slučaju mora primijeniti najniža moguća aktivnost dovoljna za dobivanje potrebnih dijagnostičkih podataka.
English: The use of Neuraceq does involve exposure to small amounts of radioactivity.
Croatian: Primjena Neuraceqa podrazumijeva izlaganje malim količinama radioaktivnosti.
English: An overdose is unlikely since you will only receive a single dose of Neuraceq precisely controlled by the nuclear medicine doctor supervising the procedure.
Croatian: Predoziranje nije vjerojatno jer ćete primiti samo jednu dozu Neuraceqa, i to pod strogim nadzorom liječnika specijalista nuklearne medicine koji će nadgledati postupak.
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authority in each Member State where Neuraceq is marketed, at launch and after launch, all physicians who are expected to use Neuraceq have access to a training programme in order to ensure accurate and reliable interpretation of the PET images.
Croatian: Nositelj odobrenja će osigurati da, nakon razgovora i dogovora s nacionalnim nadležnim tijelom u svakoj državi članici u kojoj se Neuraceq stavlja na tržište, pri puštanju lijeka u promet i nakon puštanja lijeka u promet, svi liječnici za koje se očekuje da će koristiti Neuraceq imaju pristup programu obuke kako bi se osigurala točna i pouzdana interpretacija slika dobivenih PET-om.
English: Pharmacotherapeutic group: diagnostic radiopharmaceuticals, central nervous system;
Croatian: Farmakoterapijska skupina: dijagnostički radiofarmaceutici, središnji živčani sustav.
English: Neuraceq should not be diluted.
Croatian: Neuraceq se ne smije razrjeđivati.
English: Your doctor and the nuclear medicine doctor have considered that the clinical benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to radiation.
Croatian: Vaš liječnik i specijalist nuklearne medicine zaključili su da prednosti ove pretrage u kojoj se primjenjuje radiofarmaceutik nadmašuju rizik od izlaganja zračenju.
English: Administration of Neuraceq and conduct of the procedure
Croatian: Primjena Neuraceqa i provedba postupka
English: Due to the small quantity of florbetaben (18F) in each dose, overdose is not expected to result in pharmacological effects.
Croatian: Zbog male količine florbetabena (18F) u svakoj dozi ne očekuje se da bi predoziranje moglo imati farmakološke učinke.
English: For precautions with respect to environmental hazard, see section 6.6.
Croatian: Za mjere opreza s obzirom na opasnosti po okoliš, vidjeti dio 6.6.
English: The overall decision of the visual PET scan assessment is subject-based and based on a binary outcome as ‘positive' or ‘negative‘.
Croatian: Krajnja odluka o vizualnoj procjeni slike dobivene PET-om ovisi o ispitaniku, a temelji se na binarnom ishodu kao 'pozitivno' ili 'negativno'.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava; navedenog u Dodatku V.
English: Paediatric population For information on the use in the paediatric population, see sections 4.2 or 5.1.
Croatian: Za podatke o primjeni u pedijatrijskoj populaciji vidjeti dijelove 4.2 ili 5.1.
English: Seibersdorf Labor GMBH Grundstueck Nr. 482/2 EZ 98 KG 2444 Seibersdorf Austria
Croatian: Seibersdorf Labor GmbH Grundstueck Nr. 482/2 EZ 98 KG 2444 Seibersdorf Austrija
English: The table below shows the dosimetry as calculated using the OLINDA (Organ Level INternal Dose Assessment) software.
Croatian: Tablica u nastavku prikazuje dozimetriju izračunatu pomoću OLINDA (engl.,Organ Level INternal Dose Assessment) softvera.
English: Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients (see section 4.4).
Croatian: Potrebno jepažljivo razmotriti količinu aktivnosti pri primjeni budući da u ovih bolesnika postoji mogućnost povećane izloženosti zračenju (vidjeti dio 4.4).
English: What Neuraceq is and what it is used for
Croatian: Što je Neuraceq i za što se koristi
English: The results were lower than the results obtained in the pivotal trial: a sensitivity range between 77.5% to 90% and specificity range between 62.5-85.7%.
Croatian: Njihovi rezultati bili su lošiji od rezultata dobivenih u ključnom ispitivanju: osjetljivost se kretala između 77,5 do 90%, a specifičnost između 62,5 do 85,7%.
English: The effective dose resulting from the administration of a maximal recommended activity of 360 MBq dose for an adult weighing 70 kg is about 7.0 mSv.
Croatian: Efektivna doza nakon primjene maksimalne preporučene doze aktivnosti od 360 MBq u odrasle osobe težine 70 kg iznosi približno 7,0 mSv.
English: The estimated absorbed radiation doses to organs are listed in Table 3, providing data from Caucasian healthy volunteers (n=17).
Croatian: Procijenjene apsorbirane doze zračenja u organima su navedene u Tablici 3, dobivene od zdravih dobrovoljaca bijele rase (n=17).
English: The nuclear medicine doctor supervising the procedure will decide on the amount of Neuraceq to be used in your case.
Croatian: Liječnik specijalist nuklearne medicine koji će nadzirati postupak odredit će količinu Neuraceqa primjerenu u Vašem slučaju.
English: RCTU score 3 at least in one of 4 brain regions
Croatian: RCTU ocjena 3 u najmanje jednomod 4 područja mozga
English: Chronic studies and carcinogenicity studies have not been carried out, since the medicinal product is not intended for regular or continuous administration.
Croatian: Dugotrajna ispitivanja i ispitivanja karcinogenosti nisu provedena, jer ovaj lijek nije namijenjen za redovitu ili kontinuiranu primjenu.
English: As a result of differences in the manufacturing process, it is possible that some vials are distributed with punctured rubber stoppers.
Croatian: Zbog razlika u proizvodnom postupku, neke bočice mogu biti isporučene s probušenim gumenim čepom.
English: Feeling hot
Croatian: Osjećaj vrućine
English: Tracer uptake (i.e., signal intensity) in grey matter in the region is lower than in white matter.
Croatian: Unos obilježivača (tj. intenzitet signala) u sivoj tvari u regiji je niži nego u bijeloj tvari.
English: BAPL score
Croatian: BAPL bodovi
English: Method of preparation The package must be checked before use and the activity measured using an activimeter.
Croatian: Način pripreme Prije uporabe mora se pregledati pakiranje i izmjeriti aktivnost uređajem za mjerenje aktivnosti.
English: The European Medicines Agency has waived the obligation to submit the results of studies with florbetaben (18F) in all subsets of the paediatric population as the disease or condition for which the specific medicinal product is intended only occurs in adult population, and the specific medicinal product does not represent a significant therapeutic benefit over existing treatments for paediatric patients (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka florbetabena (18F) u svim podskupinama pedijatrijske populacije jer se lijek ne namjerava primjenjivati u pedijatrijskoj populaciji budući se bolest ili stanje za koje je ovaj lijek namijenjen javlja samo kod odraslih osoba, a specifičan lijek ne predstavlja značajnu prednost nad postojećim liječenjem za pedijatrijske bolesnike (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Fluorine (18F) decays to stable oxygen (18O) with a half-life of approximately 110 minutes by emitting a positron radiation of 634 keV, followed by photonic annihilation radiation of 511 keV.
Croatian: Fluor (18F) se raspada na stabilni kisik (18O) čiji je poluvijek približno 110 minuta, emisijom pozitronskog zračenja energije 634 keV, nakon kojega slijedi fotonsko anihilacijsko zračenje energije
English: Neuraceq contains ethanol and sodium ascorbate
Croatian: Neuraceq sadrži etanol i natrijev askorbat
English: Red marrow Osteogenic cells Skin
Croatian: Crvena koštana srž Osteogene stanice Koža
English: What Neuraceq is and what it is used for What you need to know before Neuraceq is used How Neuraceq will be used Possible side effects
Croatian: Što je Neuraceq i za što se koristi Što morate znati prije primjene Neuraceqa Kako se primjenjuje Neuraceq
English: Interpretation of the images is made visually comparing the activity in cortical grey matter with activity in adjacent cortical white matter.
Croatian: Tumačenje slika se radi vizualnom usporedbom aktivnosti u sivoj tvari korteksa s aktivnošću u susjednoj kortikalnoj bijeloj tvari.
English: The reader should compare the cortical grey matter signal intensity to the maximum white matter signal intensity.
Croatian: Dijagnostičar treba usporediti intenzitet signala kortikalne sive tvari s maksimalnim intenzitetom signala bijele tvari.
English: Florbetaben (18F) should not be diluted.
Croatian: Florbetaben (18F) se ne smije razrjeđivati.
English: The solution should be inspected visually prior to use.
Croatian: Otopinu je prije uporabe potrebno vizualno pregledati.
English: This medicine will only be handled and given to you by professionals who are trained and qualified to use it safely.
Croatian: Ovaj lijek će primijeniti i njime rukovati samo profesionalne osobe obučene za njegovu sigurnu primjenu.
English: At 12 hours post-injection, up to approximately 30% of the injected radioactivity is excreted with urine.
Croatian: Dvanaest sati nakon injekcije, do približno 30% ubrizgane radioaktivnosti se izlučuje mokraćom.
English: For an administered activity of 360 MBq the typical radiation dose to the target organ (brain) is 4.5 mGy.
Croatian: Kod primjene aktivnosti od 360 MBq uobičajena doza zračenja za ciljni organ (mozak) iznosi 4,5 mGy.
English: The quantity to be administered usually recommended for an adult is 300 MBq (megabecquerel, the unit used to express radioactivity).
Croatian: Uobičajena preporučena količina koja se primjenjuje u rasponu za odrasleje 300 MBq (megabecquerel je jedinica kojom se izražava radioaktivnost).
English: This medicine is intended for adults only.
Croatian: Ovaj lijek namijenjen je samo za primjenu u odraslih.
English: Neuraceq is a clear, colourless solution for injection.
Croatian: Neuraceq je bistra, bezbojna otopina za injekciju.
English: Some scans may be difficult to interpret due to image noise, atrophy with a thinned cortical ribbon, or image blurs, which could lead to interpretation errors.
Croatian: Neke slike može biti teško tumačiti zbog artefaka ta na slikama, atrofije sa stanjenim korteksom ili zamućenja na slikama što može dovesti do pogrešaka u tumačenju.
English: The complete SmPC of Neuraceq is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Croatian: Cjeloviti sažetak opisa svojstava lijeka za Neuraceq priložen je u pakiranju lijeka kao zaseban dokument, a cilj mu je zdravstvenim radnicima pružiti dodatne znanstvene i praktične informacije o primjeni i uporabi ovoga radiofarmaceutika.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: No radioactivity could be measured in blood at about 4 hours post injection.
Croatian: Radioaktivnost u krvi je nemjerljiva otprilike 4 sata nakon injekcije.
English: Note: For a score of tracer uptake in the cortex, the finding should have been present in the majority of the slices within the region in question.
Croatian: Napomena: Za ocjenu unosa obilježivača u korteks, nalaz treba biti prisutan u većini slojeva regije koja se ispituje.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane od ozbiljnijih prema manje ozbiljnim.
English: The vials must not be opened before disinfecting the stopper, the solution should be withdrawn via the stopper using a single dose syringe fitted with suitable protective shielding and a disposable sterile needle or using an authorised automated application system.
Croatian: Prije otvaranja bočice čep se mora dezinficirati, a zatim se otopina iz bočice izvlači kroz čep uz pomoć jednodozne štrcaljke opremljene odgovarajućim zaštitnim pokrovom i sterilne igle za jednokratnu uporabu ili uz pomoć odobrenog automatiziranog sustava za primjenu.
English: Common (may affect up to 1 in 10 people): - Injection site reactions: injection site pain, redness of the skin at injection site (injection /
Croatian: Često (mogu se javiti u do 1 na 10 osoba): - Reakcije na mjestu injekcije: bol na mjestu injekcije, crvenilo kože na mjestu injekcije (eritem na mjestu injekcije /primjene)
English: A 20-minute PET image should be acquired starting at approximately 90 minutes after intravenous injection of florbetaben (18F).
Croatian: 20-minutno snimanje PET-om potrebno je započeti otprilike 90 minuta nakon intravenske injekcije florbetabena (18F).
English: 1 (No tracer uptake)
Croatian: 1 (Nema unosa obilježivača)
English: EXP {DD/MM/YYYY} {XX}h{XX} {Time zone}
Croatian: Rok valjanosti{DD/MM/GGGG} {XX}h{XX} {vremenska zona}
English: Sensitivity and specificity to estimate beta-amyloid deposition of florbetaben (18F) was further investigated in one additional study, in which a different set of 5 electronically-trained blinded readers interpreted images from 54 subjects followed to autopsy in the pivotal study.
Croatian: Osjetljivost i specifičnost florbetabena (18F) u otkrivanju beta-amiloidnih depozita dodatno je proučavana u jednom ispitivanju u kojem je druga skupina od 5 elektronički podučenih dijagnostičara na slijepo tumačila slike 54 ispitanika koji su u ključnom ispitivanju bili praćeni do obdukcije.
English: Express breast milk during this period and discard the breast milk you have expressed.
Croatian: Tijekom tog perioda izdojite mlijeko i bacite ga.
English: Talk to your nuclear medicine doctor before you are given Neuraceq if you: - have kidney problems - have liver problems - are pregnant or think you may be pregnant - are breast-feeding
Croatian: Obratite se svom liječniku specijalistu nuklearne medicine prije nego Vam daju Neuraceq: - ako imate tegoba s bubrezima - ako imate tegoba s jetrom - ako ste trudni ili mislite da biste mogli biti trudni - ako dojite
English: Cis Bio International Hôpital Xavier Arnozan Avenue du Haut Lévèque 33600 Pessac (Bordeaux) France
Croatian: Cis Bio International Hôpital Xavier Arnozan Avenue du Haut Lévèque 33600 Pessac (Bordeaux) Francuska
English: Store in the original package to protect from ionizing radiation (lead shielding).
Croatian: POSEBNE MJERE ČUVANJA Čuvati u originalnom pakiranju radi zaštite od ionizirajućeg zračenja (olovni spremnik).
English: A positive scan does not independently establish a diagnosis of AD or other cognitive disorder since neuritic plaque deposition in grey matter may be present in asymptomatic elderly and some neurodegenerative dementias (AD, Lewy body dementia, Parkinson's disease dementia).
Croatian: Pozitivan nalaz sam po sebi ne znači dijagnozu Alzheimerove bolesti ili nekog drugog kognitivnog poremećaja budući da stvaranje neuritičkih plakova u sivoj tvari može biti prisutno u asimptomatskih starijih osobate kod nekih neurodegenerativnih demencija (AB, demencija s Lewyjevim tjelešcima, demencija kod Parkinsonove bolesti).
English: Before administering radiopharmaceuticals to a mother who is breast-feeding consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breast-feeding, and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk.
Croatian: Prije primjene radiofarmaceutika u dojilja potrebno je razmotriti mogućnost odgode primjene radionuklida do prestanka dojenja te odrediti koji je radiofarmaceutik najprikladniji s obzirom na izlučivanje aktivnosti u majčino mlijeko.
English: Unit 19, Quadrum Park, Old Portsmouth Road, Peasmarsh, Guildford, Surrey, GU3 1LU United Kingdom
Croatian: Unit 19, Quadrum Park, Old Portsmouth Road, Peasmarsh, Guildford, Surrey, GU3 1LU Ujedinjeno Kraljevstvo
English: 29 (64.4%) of MCI patients were positive by florbetaben (18F) PET scan.
Croatian: Dvadeset devet (64,4%) bolesnika s MCI su bila pozitivna u PET oslikavanju uz primjenu florbetabena (18F).
English: Cortical SUV ratios (SUVRs, relative to cerebellar cortex) are higher in AD patients compared with those of healthy volunteer subjects.
Croatian: Omjeri SUV-a za korteks (SUVR-i u odnosu na korteks malog mozga) viši su u bolesnika s Alzheimerovom bolešću nego u zdravih dobrovoljaca.
English: In particular, the nuclear medicine doctor in charge of the procedure may provide ways to increase the passing of urine and stools in order to help remove radioactivity from your body.
Croatian: Konkretno, liječnik specijalist nuklearne medicine koji provodi postupak može primijeniti određene metode kojima se povećava učestalost mokrenja i stolice kako bi se ubrzalo uklanjanje radioaktivnosti iz tijela.
English: In the event of administration of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by frequent micturition and defecation.
Croatian: U slučaju primjene prevelike doze zračenja, dozu koju je bolesnik apsorbirao potrebno je, kad je to moguće, smanjiti ubrzavanjem eliminacije radionuklida iz tijela čestim mokrenjem i defekacijom.
English: Uptake of radioactivity in the brain is rapid, reaching about 6% of injected radioactivity at 10 minutes post injection.
Croatian: Nakupljanje radioktivnosti u mozgu događa se brzo, dosežući 6% injicirane radioaktivnosti u 10