FrancophonIA/ELRC3.0 huggingface dataset:
English: No animal studies have been conducted to investigate the reproductive effects in florbetaben (18F) (see section 5.3).
Croatian: Nisu provedena ispitivanja na životinjama kojima bi se ispitali učinci florbetabena (18F) na reprodukciju (vidjeti dio 5.3).
English: For the limitations of use in patients with mild cognitive impairment (MCI), see section 5.1.
Croatian: Za ograničenja primjene u bolesnika s blagim oštećenjem kognitivne funkcije (engl., mild cognitive impairment, MCI) vidjeti dio 5.1.
English: This medicinal product contains up to 1.2 g of ethanol and up to 33 mg of sodium per dose (see section 4.4).
Croatian: Ovaj lijek sadrži do 1,2 g etanola i do 33 mg natrija po dozi (vidjeti dio 4.4).
English: The biophysical basis of the white matter retention of florbetaben (18F) in the living human brain cannot be definitively explained.
Croatian: Biofizikalna osnova retencije florbetabena (18F) u bijeloj tvari u živom ljudskom mozgu se ne može u potpunosti objasniti.
English: The recommended activity for an adult is 300 MBq florbetaben (18F).
Croatian: Preporučena aktivnost za odraslu osobu iznosi 300 MBq florbetabena (18F).
English: Curium Pharma Spain, S.A. Thomas Alba Edison, s/n 41092 Seville
Croatian: Thomas Alba Edison, s/n 41092 Seville
English: PET images are read in a transaxial orientation using a grey scale.
Croatian: Slike dobivene PET-om potrebno je očitavati u transaksijalnoj ravnini, uporabom sive skale.
English: A negative scan indicates sparse or no density of cortical β-amyloid plaques.
Croatian: Negativan nalaz upućuje na malu gustoću ili nepostojanje β-amiloidnih kortikalnih plakova.
English: Pol. Ind. Conpisa, C/ Veguillas, 2 Nave 16, Ajalvir 28864 (Madrid) Spain
Croatian: Ind. Conpisa, C/ Veguillas, 2 Nave 16, Ajalvir 28864 (Madrid) Španjolska
English: Pregnant
Croatian: Trudnoća
English: Table 4: Estimated radiation absorbed doses from intravenous injection of Neuraceq to Caucasian subjects
Croatian: Tablica 4: Procijenjene apsorbirane doze zračenja od intravenske injekcije Neuraceqa ispitanicima bijele rase
English: Neuraceq is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of β-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment.
Croatian: Neuraceq je radiofarmaceutik indiciran za mjerenje gustoće neuritičkih plakova građenih od β amiloida pozitronskom emisijskom tomografijom (PET) u mozgu odraslih bolesnika s kognitivnim oštećenjima, u svrhu dijagnosticiranja Alzheimerove bolesti (AB) i drugih uzroka kognitivnih oštećenja.
English: Florbetaben (18F) is highly bound to plasma proteins (>98.5%).
Croatian: Florbetaben (18F) se vezuje na bjelančevine plazme s visokim afinitetom (>98,5%).
English: - This medicine contains up to 33 mg sodium (main component of cooking/table salt) in each dose.
Croatian: Ovaj lijek sadrži 33 mg natrija (glavni sastojak kuhinjske soli) u jednoj dozi.
English: You must inform the nuclear medicine doctor before you are given Neuraceq if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.
Croatian: Morate obavijestiti liječnika specijalistu nuklearne medicine prije nego primite Neuraceq ako postoji mogućnost da ste trudni, ako Vam je izostala mjesečnica ili ako dojite.
English: Florbetaben (18F) is eliminated from plasma of AD patients with a mean biological half-life of about 1 hour.
Croatian: Eliminacija Florbetaben (18F) se eliminira iz plazme bolesnika s Alzheimerovom bolešću sa srednjom vrijednošću biološkog poluvijeka od oko 1 sat.
English: The efficacy of florbetaben (18F) for predicting development of AD or monitoring response to therapy has not been established (see section 5.1).
Croatian: Nije ustanovljena djelotvornost florbetabena (18F) u predviđanju razvoja Alzheimerove bolesti niti u praćenju odgovora na liječenje (vidjeti dio 5.1).
English: Interpretation of Neuraceq images
Croatian: Tumačenje slika pri primjeni Neuraceqa
English: What Neuraceq looks like and contents of the pack
Croatian: Kako Neuraceq izgleda i sadržaj pakiranja
English: Uptake has also been identified in some cases in extracerebral structures such as face, scalp and bone.
Croatian: U nekim je slučajevima također utvrđeno nakupljanje u ekstracerebralnim strukturama kao što su lice, vlasište i kosti.
English: After intravenous bolus injection a radioactivity concentration of 2-3% injected dose/L is achieved in arterial plasma 10 minutes after injection.
Croatian: Deset minuta nakon intravenske bolus injekcije postiže se koncentracija radioaktivnosti od 2-3% injicirane doze/l u arterijskoj plazmi.
English: Pharmacodynamic effects At the low chemical concentrations present in Neuraceq, florbetaben (18F) does not have any detectable pharmacodynamic activity.
Croatian: Pri niskim kemijskim koncentracijama koje su prisutne u Neuracequ, florbetaben (18F) nema zamjetnu farmakodinamičku aktivnost.
English: A Neuraceq PET scan, along with other brain function tests, can help your doctor determine whether or not you may have β-amyloid plaques in your brain.
Croatian: PET oslikavanje primjenom Neuraceqa zajedno s drugim testovima moždane funkcije, liječnicima pomaže utvrditi imate li u mozgu naslage β-amiloida.
English: It is hypothesised that unspecific binding of the radiopharmaceutical to the lipid-containing myelin sheath may contribute to white matter retention.
Croatian: Pretpostavlja se da nespecifično vezanje radiofarmaceutika na mijelinske ovojnice koje sadržavaju lipide može pridonijeti retenciji u bijeloj tvari.
English: A subject is classified as “positive” or “negative” based on the brain amyloid plaque load (BAPL) score (Table 2) which is derived from RCTU scores in the four brain regions (Table 1).
Croatian: Ispitanik je klasificiran kao "pozitivan" ili "negativan" na temelju rezultata opterećenja moždanog tkiva amiloidnim plakovima (engl., brain amyloid plaque load, BAPL) (tablica 2) koje je izvedeno iz rezultata unosa obilježivača u kortikalnu regiju učetiri područja mozga (tablica 1).
English: Neuraceq should be used in conjunction with a clinical evaluation.
Croatian: Primjenu Neuraceqa je potrebno kombinirati s kliničkom procjenom.
English: In completed clinical trials, uptake of florbetaben (18F) in 7 predefined cortical areas of the brain (frontal, parietal, lateral and medial temporal, occipital, caudate, posterior cingulate/precuneus cortex, and anterior cingulate gyrus) and cerebellar cortex was measured quantitatively using standardised uptake values (SUV).
Croatian: U završenim kliničkim ispitivanjima nakupljanje florbetabena (18F) u 7 prethodno definiranih kortikalnih područja mozga (frontalno, parijetalno, lateralno i medijalno temporalno, okcipitalno, kaudatus, stražnji cingularni korteks/precuneus i prednji cingularni girus) i korteksu malog mozga izmjereno je kvantitativno primjenom standardiziranih vrijednosti nakupljanja (engl., standardized uptake values, SUV).
English: Image interpretation errors in the estimation of brain β-amyloid neuritic plaque density, including false negatives and false positives, have been observed.
Croatian: Primijećene su pogreške u tumačenju slika kod procjene gustoće β-amiloidnih neuritičkih plakova u mozgu, uključujući lažno negativne i lažno pozitivne nalaze.
English: RCTU score 1 in each of the 4 brain regions (lateral temporal lobes, frontal lobes, posterior cingulate/precuneus, parietal lobes)
Croatian: RCTU ocjena 1 u svakom od 4 područja mozga (lateralni temporalni režnjevi, frontalni režnjevi, stražnji cingularni korteks/precuneus, parijetalni režnjevi)
English: The PET results were compared with the maximal neuritic plaque density measured on sections of middle frontal gyrus, superior and middle temporal gyri, inferior parietal lobe, hippocampus and other brain regions at the patient's autopsy.
Croatian: Rezultati PET-a uspoređeni su s maksimalnom gustoćom neuritičkih plakova izmjerenom na slojevima srednjeg frontalnog girusa, gornjeg i srednjih temporalnih girusa, donjem parijetalnom režnju, hipokampusu i drugim područjima mozga, tijekom obdukcije bolesnika.
English: In AD subjects, as in controls, there is high retention in pons and other white matter areas.
Croatian: U ispitanika s Alzheimerovom bolešću, kao i u kontrolnih ispitanika, razina retencije u ponsu i drugim regijama bijele tvari je visoka.
English: A PET scan with florbetaben (18F) should be requested by clinicians experienced in the clinical management of neurodegenerative disorders.
Croatian: PET pretragu s florbetabenom (18F) treba preporučiti liječnik s iskustvom u kliničkom liječenju neurodegenerativnih poremećaja.
English: A large confluent area of tracer uptake equal to or higher than that present in white matter extending beyond the white matter rim to the outer cortical margin and involving the entire region including the majority of slices within the respective region.
Croatian: Veliki konfluentni prostor unosa obilježivača jednak ili veći od onog prisutnog u bijeloj tvari proteže se izvan ruba bijele tvari prema vanjskom rubu korteksa i koji uključuje cijelu regiju uključujući i većinu slojeva unutar promatrane regije.
English: Hyperhidrosis
Croatian: Osip Hiperhidroza
English: Neuraceq is given as an injection into your vein (intravenous injection) followed by a flush of sodium chloride solution to ensure full delivery of the dose.
Croatian: Neuraceq se primjenjuje u obliku injekcije u venu (intravenska injekcija) nakon koje se daje otopina natrijeva klorida kojom se osigurava primjena cjelokupne doze.
English: - The other ingredients are ascorbic acid, ethanol anhydrous, macrogol 400, sodium ascorbate, and water for injections (see section 2 “Neuraceq contains ethanol and sodium ascorbate”).
Croatian: - Drugi sastojci su askorbatna kiselina,bezvodni etanol, makrogol 400, natrijev askorbat i voda za injekcije (vidjeti dio 2 „Neuraceq sadrži etanol i natrijev askorbat“).
English: Each of these brain regions, the lateral temporal, frontal, posterior cingulate, precuneus, and parietal lobes should be systematically visually assessed and scored according to the regional cortical tracer uptake (RCTU) score (Table 1).
Croatian: Svako od tih područja mozga, lateralno temporalno, frontalno, stražnji cingularni korteks, precuneus i parijetalni režnjevi treba biti sustavno vizualno procjenjeno i bodovano prema rezultatu unosa obilježivača u kortikalnu regiju (engl., regional cortical tracer uptake, RCTU), (Tablica 1).
English: Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
Croatian: U ovih bolesnika potrebno je pažljivo razmotriti omjer koristi i rizika budući da postoji mogućnost povećane izloženosti zračenju.
English: Life Radiopharma Warszawa Sp. z o.o.
Croatian: Life Radiopharma Warszawa Sp. z o.o. ul.
English: If the injection volume ranges between 0.5 and 1 mL, only syringes of an appropriate size (1 mL) should be used and the syringe needs to be flushed out with sodium chloride solution (see section 12).
Croatian: Ako injekcijski volumen iznosi između 0,5 i 1 ml, potrebno je koristiti samo štrcaljke odgovarajuće veličine (1 ml), a štrcaljku je potrebno isprati s otopinom natrijevog klorida (vidjeti dio 12).
English: If the injection volume ranges between 0.5 and 1 mL, only syringes of an appropriate size (1 mL) should be used and the syringe needs to be flushed out with sodium chloride solution.
Croatian: Ako injekcijski volumen iznosi između 0,5 i 1 ml, treba koristiti samo štrcaljke odgovarajuće veličine (1 ml), a štrcaljku je potrebno isprati s otopinom natrijevog klorida.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.:Sažetak opisa svojstava lijeka, dio 4.2)
English: In a longitudinal study, 45 subjects clinically diagnosed with mild cognitive impairment (MCI), underwent baseline florbetaben (18F) PET scans, and were followed for 24 months to evaluate the relationship between florbetaben (18F) imaging and changes in diagnostic status.
Croatian: U longitudinalnom je ispitivanju 45 ispitanika s kliničkom dijagnozom blagog oštećenja kognitivne funkcije (MCI) na početku podvrgnuto PET-i uz primjenu florbetabena (18F) te su 24 mjeseca praćeni kako bi se ocijenila povezanost između oslikavanja uz primjenu florbetabena (18F) i promjena dijagnostičkog statusa.
English: - This medicine contains 15 vol % ethanol (alcohol), i.e. up to 1.2 g per dose, equivalent to 30 mL beer or 12.5 mL wine per dose.
Croatian: Ovaj lijek sadrži 15 vol % etanola (alkohola), tj. do 1,2 g po dozi, što odgovara 30 ml piva, 12,5 ml vina po dozi.
English: Healthy controls show relatively low levels of florbetaben (18F) retention in cortex.
Croatian: Podaci u zdravih kontrolnih ispitanika pokazuju relativno nisku razinu nakupljanja florbetabena (18F) u korteksu.
English: Toxic skin eruption Rash
Croatian: Toksična kožna erupcija
English: For cases in which there is uncertainty about the location of grey matter and of the grey/white matter border on the PET scan, and a co-registered recent CT or MR image is available, the interpreter should examine the fused PET-CT or PET-MR image to clarify the relationship of the PET radioactivity and the grey matter anatomy.
Croatian: U slučajevima kada se na slici dobivenoj PET-om ne može sa sigurnošću lokalizirati siva tvar te odrediti granica između sive i bijele tvari, a dostupna je nedavno učinjena relevantna CT ili MR slika, dijagnostičar treba proučiti fuzionirane PET-CT ili PET-MR slike kako bi razjasnio odnos između radioaktivnosti na slici dobivenoj PET-om i anatomije sive tvari.
English: 1 Scan without beta-amyloid deposition
Croatian: 1 Slika bez beta-amiloidnih depozita
English: Neuraceq is given to people with memory problems so that doctors can perform a type of brain scan, called a PET scan.
Croatian: Neuraceq se daje osobama koje imaju tegoba s pamćenjem kako bi liječnici mogli provesti snimanje mozga koje se naziva PET oslikavanje.
English: A pivotal study in 31 end-of-life patients was aimed at establishing the diagnostic performance of florbetaben (18F) to detect the cortical neuritic plaque density (no or sparse vs. moderate or frequent) as established by the CERAD criteria.
Croatian: Cilj ključnog ispitivanja u kojem je sudjelovao 31 bolesnik koji se bliži kraju života bio je utvrditi dijagnostičku uspješnost florbetabena (18F) u otkrivanju gustoće kortikalnih neuritičkih plakova (nema ili su rijetki naspram umjereni ili česti) kako je utvrđeno prema CERAD kriterijima.
English: Smaller area(s) of tracer uptake equal to or higher than that present in white matter: extending beyond the white matter rim to the outer cortical margin involving the majority of the slices within the respective region.
Croatian: Manji prostor(i) unosa obilježivača jednak ili veći od onog prisutnog u bijeloj tvari: proteže se izvan ruba bijele tvari prema vanjskom rubu korteksa koji uključuje većinu slojeva unutar promatrane regije.
English: • The training material should include Neuraceq PET demonstration cases with correct PET scan interpretation by an experienced reader Neuraceq-PET scans for self-assessment and a selfqualification procedure to be offered to each trainee.
Croatian: • Materijal za obuku treba uključiti prikaz slučajeva snimanja PET-om uz Neuraceq s ispravnim tumačenjem slika dobivenih PET-om od strane iskusnog dijagnostičara s iskustvom u očitavanju slika dobivenih PET-om uz Neuraceq u svrhu samoocjenjivanja i samoprovjere što će biti ponuđeno svakom vježbeniku.
English: Customer ref
Croatian: Ref. klijenta
English: Cis Bio International CHU de Brabois Avenue de Bourgogne 54500 Vandoeuvre les Nancy France
Croatian: Cis Bio International CHU de Brabois Avenue de Bourgogne 54500 Vandoeuvre les Nancy Francuska
English: The dose is administered by intravenous slow bolus injection (6 sec/mL) followed by a flush of approximately 10 mL of sodium chloride 9 mg/mL (0.9%) solution for injection to ensure full delivery of the dose.
Croatian: Doza se primjenjuje polaganom intravenskom bolus injekcijom (6 sekundi/ml), nakon čega se daje oko 10 ml 9 mg/ml (0,9 %) otopine natrijeva klorida za injekciju kojom se osigurava primjena cjelokupne doze lijeka.
English: • Relevant information on Neuraceq as anβ-amyloid PET tracer, including the approved indication according to the SmPC, limitations of Neuraceq use, interpretation errors, safety information and the results of clinical trials informing on the diagnostic use of Neuraceq;
Croatian: uključujući odobrene indikacije prema Sažetku opisa svojstava lijeka, ograničenja uporabe Neuraceqa, pogreške u tumačenju, sigurnosne informacije i rezultate kliničkih ispitivanja o primjeni Neuraceqa u dijagnostici;
English: Based on in vitro investigations florbetaben (18F) is metabolised predominantly by CYP2J2 and CYP4F2.
Croatian: Na temelju in vitro ispitivanja, florbetaben (18F) se metabolizira pretežno putem CYP2J2 i
English: Sensitivity of florbetaben (18F) scan to show the MCI conversion rate to AD in 19 converters was 100%, specificity in 26 non-converters was 61.5% (95% CI: 42.8-80.2%) and positive likelihood ratio was 2.60 (1.60-4.23).
Croatian: Osjetljivost oslikavanja uz florbetaben (18F) pri utvrđivanju stope konverzije iz blagog oštećenja kognitivne funkcije u Alzheimerovu bolest u 19 bolesnika iznosila je 100%, dok je specifičnost u 26 bolesnika u kojih nije došlo do konverzije iznosila 61,5% (95% CI: 42,8-80,2%), pri čemu je omjer pozitivne vjerojatnosti bio 2,60 (1,60-4,23).
English: Table 1: Definitions of regional cortical tracer uptake (RCTU) RCTU score
Croatian: Tablica 1: Definicije unosa obilježivača u kortikalnu regiju (RCTU)
English: A positive scan indicates moderate to frequent density.
Croatian: Pozitivan nalaz upućuje na umjerenu do veliku gustoću.
English: In addition, binding of florbetaben (18F) to β-amyloid plaques in post-mortem AD brain sections was demonstrated by autoradiography and supported by immunohistochemistry or Bielschowsky stain.
Croatian: Osim toga, vezivanje florbetabena (18F) za β-amiloidne plakove na slojevima mozgova obduciranih osoba oboljelih od Alzheimerove bolesti je pokazano autoradiografski i potvrđeno imunohistokemijom ili bojanjem prema Bielschowskom.
English: Pain in extremity Limb discomfort
Croatian: Bolovi u ekstremitetima Nelagoda u udovima
English: If the integrity of the vial is compromised, the medicinal product should not be used.
Croatian: Ako je bočica oštećena, lijek se ne smije upotrijebiti.
English: Cis Bio International 14, rue de la Grange aux Belles 75010 Paris
Croatian: Cis Bio International 14, rue de la Grange aux Belles 75010 Pariz
English: In vitro, florbetaben (18F) shows nanomolar binding affinity to synthetic β-amyloid fibrils and to AD brain homogenate.
Croatian: In vitro, florbetaben (18F) pokazuje afinitet vezivanja u nanomolarnoj razini za sintetska β-amiloidna vlakna i za AB homogenat u mozgu.
English: The images should be viewed in a systematic manner (Figure 1) starting at the level of cerebellum and scrolling up through the lateral temporal and frontal lobes, then to the area of the posterior cingulate cortex and precuneus, and finally to the parietal lobe.
Croatian: Slike je potrebno očitavati sistematski (slika 1), počevši od razine malog mozga, potom kroz lateralne temporalne i frontalne režnjeve, zatim na područje stražnjeg cingularnog korteksa i precuneusa, do parijetalnog režnja na kraju.
English: Colourless 15 mL Type I glass vial, sealed with a chlorobutyl stopper and aluminium seal.
Croatian: Bočica od bezbojnog stakla tipa I, od 15 ml, zatvorena klorbutilnim čepom i aluminijskim prstenom.
English: Rule for assessment
Croatian: Pravila za procjenu
English: The administration of radiopharmaceuticals creates risks for other persons (including pregnant healthcare professionals) from external radiation or contamination from spill of urine, vomiting, etc.
Croatian: Primjena radiofarmaceutika rizična je za druge osobe (uključujući trudne zdravstvene djelatnice) jer može doći do vanjskog zračenja ili kontaminacije uslijed prolijevanja mokraće, povraćanja itd., zbog toga se moraju poduzeti mjere zaštite od zračenja u skladu s nacionalnim propisima.
English: Increased uptake has been identified in extracerebral structures such as face, scalp and bone in some cases.
Croatian: U nekim je slučajevima utvrđeno povećano nakupljanje u ekstracerebralnim strukturama kao što su lice, vlasište i kosti.
English: Residual activity in the midsagittal sinus can be sometimes observed (see section 5.2).
Croatian: Povremeno se može opaziti rezidualna aktivnost u sagitalnom sinusu (vidjeti dio
English: This medicinal product contains up to 33 mg sodium per dose, equivalent to 1.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Ovaj lijek sadrži do 33 mg natrija po dozi, što odgovara 1,6 % maksimalnog dnevnog unosa od 2 g natrija prema preporukama SZO za odraslu osobu.
English: Mechanism of action Florbetaben (18F) binds to β-amyloid neuritic plaques in the brain.
Croatian: Florbetaben (18F) se veže za β-amiloidne neuritičke plakove u mozgu.
English: Avoid any close contact with young children and pregnant women for 24 hours following the injection.
Croatian: Izbjegavati blizak kontakt s malom djecom i trudnicama tijekom 24 sata nakon injekcije.
English: Figure 1: Neuraceq PET cases showing examples of negative florbetaben (18F) PET scan (top row) and positive scan (bottom row).
Croatian: Slika 1: Nalazi slika dobivenih PET-om uz Neuraceq koji pokazuju primjere negativnih PET slika uz florbetaben (18F) (gornji red) i pozitivnih slika (donji red)
English: - If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
Croatian: - Ako imate dodatnih pitanja, obratite se svom liječniku specijalistu nuklearne medicine koji će nadzirati postupak.
English: In AD subjects, cortical regions and striatal regions show significantly greater uptake compared to controls.
Croatian: U ispitanika s Alzheimerovom bolešću primijećeno je značajno veće nakupljanje u kortikalnim regijama i striatumu u usporedbi s kontrolnim ispitanicima.
English: Table 3: List of adverse reactions System Organ Class
Croatian: Tablica 3: Popis nuspojava Klasifikacija organskih sustava Često
English: Florbetaben (18F) is excreted primarily through the hepatobiliary system and patients with hepatic impairment have the potential of increased radiation exposure (see section 4.2).
Croatian: Florbetaben (18F) se izlučuje prvenstveno putem hepatobilijarnog sustava pa u bolesnika s oštećenjem funkcije jetre postoji mogućnost povećane izloženosti zračenju
English: Comparing the results of PET scan reading with the histopathology assessment collected for all subjects (same as used for the original pivotal study and its post-hoc analysis), the majority read sensitivity and specificity were 100% (95%CI: 89.4-100%) and 71.4% (95%CI: 52.1-90.8%), respectively.
Croatian: Uspoređujući rezultate tumačenja nalaza PET-a s histopatolološkom procjenom učinjenom kod svih ispitanika (isto kao u izvornom ključnom ispitivanju i post-hoc analizi istog), osjetljivosti i specifičnosti su većinom iznosile 100% (95% CI: 89,4-100%) i 71,4% (95% CI: 52,1-90,8%).
English: • Review of the PET reading criteria, including method of image review, criteria for interpretation, and images demonstrating the read methodology;
Croatian: • Pregled kriterija očitavanja nalaza dobivenih PET-om, uključujući i metodu pregleda slika,
English: As the effective dose is about 5.8 mSv when the maximum recommended activity of 300 MBq of florbetaben (18F) is administered, these adverse reactions are expected to occur with a low probability.
Croatian: Budući da kod primjene maksimalne preporučene aktivnosti florbetabena (18F) od 300 MBq efektivna doza zračenja iznosi 5,8 mSv, pojava navedenih nuspojava smatra se malo vjerojatnom.