FrancophonIA/ELRC3.0 huggingface dataset:
English: The design of this study does not allow estimating the risk of MCI progression to clinical AD.
Croatian: Dizajn ovog ispitivanja ne omogućuje procjenu rizika progresije blagog kognitivnog oštećenja u kliničku Alzheimerovu bolest.
English: VIZAMYL contains the active substance flutemetamol (18F) )and is used to help diagnose Alzheimer's disease and other causes of memory loss.
Croatian: VIZAMYL sadrži djelatnu tvar flutemetamol (18F) i primjenjuje se u dijagnosticiranju Alzheimerove bolesti i drugih uzroka gubitka pamćenja.
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 bolesnik apsorbira potrebno je, kad je to moguće, smanjiti izlučivanjem radionuklida iz tijela poticanjem mokrenja i defekacije.
English: Blood glucose decreased Blood lactate dehydrogenase increased Neutrophil count increased Respiratory rate increased
Croatian: Povećanje razine laktat dehidrogenaze u krvi Povećan broj neutrofila Ubrzano disanje
English: Flutemetamol (18F) is excreted largely through the hepatobiliary system and patients with hepatic impairment have the potential of increased radiation exposure.
Croatian: Flutemetamol (18F) se većinom izlučuje putem hepatobilijarnog sustava te u bolesnika s oštećenjem funkcije jetre postoji mogućnost povećanog izlaganja zračenju.
English: Axial (a), Sagittal (b) and coronal (c) views of a negative and positive flutemetamol (18F)
Croatian: Slika 1. Aksijalni (a), sagitalni (b) i koronalni (c) prikaz negativne (lijevo) i pozitivne (desno) snimke s flutemetamolom (18F).
English: Axial view (first row), sagittal view (second row) and coronal view (third row) are displayed.
Croatian: Prikazani su aksijalni prikaz (prvi red), sagitalni prikaz (drugi red) i koronalni prikaz (treći red).
English: The majority read sensitivity and specificity were 93% (95% CI: 81% to 99%) and 84% (95% CI: 64% to 96%), respectively.
Croatian: Osjetljivost i specifičnost su iznosile 93% (95% CI: 81% do 99%), odnosno 84% (95% CI: 64% do 96%).
English: In vivo, quantitative correlation was assessed in end-of-life patients between flutemetamol (18F) uptake in cortical grey matter and the total β-amyloid burden in autopsied samples using 4G8 anti-amyloid antibody that stains β-amyloid found in both neuritic and diffuse plaques.
Croatian: In vivo, na bolesnicima na samrti je procijenjena kvantitativna korelacija između unosa flutemetamola (18F) u kortikalnu sivu tvar i ukupnog β-amiloidnog opterećenja uzoraka dobivenih obdukcijom uporabom 4G8 anti-amiloidnih protutijela koja bojaju β-amiloid nađen u neuritičkim i difuznim plakovima.
English: How VIZAMYL is stored Contents of the pack and other information
Croatian: Kako se čuva VIZAMYL Sadržaj pakiranja i druge informacije
English: To minimise radiation dose to the bladder, hydration before and after VIZAMYL administration should be encouraged in order to permit frequent voiding.
Croatian: Za minimalizaciju doze zračenja mjehura, potrebno je preporučiti hidraciju prije i nakon primjene VIZAMYL-a kako bi se omogućilo učestalo mokrenje.
English: A region is considered as having a negative (normal) pattern if the tracer signal in cortical regions is low (i.e. distinctly lower signal intensity compared with adjacent white matter and similar in intensity to the grey matter-rich regions of the cerebellum).
Croatian: Smatra se da područje ima negativni (normalni) obrazac ako je signal obilježivača u kortikalnom području nizak (tj. jasno niži intenzitet signala u usporedbi sa susjednom bijelom tvari i intenzitet jednak onome u regijama malog mozga bogatim sivom tvari).
English: VIZAMYL has not been studied in patients with significant renal or hepatic impairment.
Croatian: VIZAMYL nije proučavan u bolesnika sa značajnim oštećenjem funkcije bubrega ili jetre.
English: Adequate shielding is mandatory.
Croatian: Obavezna je adekvatna zaštitna oprema.
English: VIZAMYL has no or negligible influence on the ability to drive and use machines.
Croatian: VIZAMYL ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Position the patient supine with the patient's brain (including the cerebellum) within a single field of view.
Croatian: Postavite bolesnika u položaj na leđa tako da je bolesnikov mozak (uključujući mali mozak) unutar jednog polja.
English: Data suggest that flutemetamol (18F) is able to label cored and diffuse amyloid β deposits and neuritic plaques.
Croatian: Podaci pokazuju da je flutemetamol (18F) sposoban označiti jezgrovite i difuzne amiloidne β depozite i neuritičke plakove.
English: In a longitudinal study, 232 patients clinically diagnosed with amnestic mild cognitive impairment (aMCI), underwent baseline flutemetamol (18F) PET scans, and were followed for 36 months to evaluate the relationship between flutemetamol (18F) imaging and changes in diagnostic status.
Croatian: U longitudinalnom ispitivanju na 232 bolesnika s kliničkom dijagnozom amnestičkog blagog kognitivnog oštećenja (aMCI) učinjeno je inicijalno PET snimanje pomoću flutemetamola (18F) te su potom praćeni tijekom 36 mjeseci kako bi se procijenio odnos između snimaka dobivenih pomoću flutemetamola (18F) i promjena u dijagnostičkom statusu.
English: A region is considered positive (abnormal) if the tracer signal in cortical regions appears high (i.e., approximately at the same or higher signal intensity as adjacent white matter and greater than the grey matter-rich regions of the cerebellum).
Croatian: Područje se smatra pozitivnim (abnormalnim) ako je signal obilježivača u kortikalnim regijama visok (tj. otprilike jednak ili viši intenzitet signala nego u susjednoj bijeloj tvari i viši intenzitet signala nego u područjima malog mozga bogatim sivom tvari).
English: The other ingredients are sodium chloride and ethanol anhydrous, polysorbate 80, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate and water for injections, see section 2.
Croatian: Drugi sastojci su natrijev klorid i bezvodni etanol, polisorbat 80, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dodekahidrat i voda za injekcije, vidjeti dio 2.
English: Administration of VIZAMYL and conduct of the procedure VIZAMYL 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: VIZAMYL se daje kao injekcija u Vašu venu (intravenska injekcija) nakon čega slijedi ispiranje otopinom natrijevog klorida kako bi se osigurala primjena cijele doze lijeka.
English: Vial No: xxx
Croatian: Broj bočice: xxx
English: Activity: 400 MBq/mL at {hh:mm} {Time Zone} on {dd-mm-yyyy} Activity: YYYY MBq at hh:mm {Time Zone} dd-mm-yyyy
Croatian: Aktivnost: 400 MBq/ml u {ss:mm} {Vremenska zona} {dd-mm-gggg} Aktivnost: GGGG MBq u ss:mm {Vremenska zona} dd-mm-gggg
English: The negative images show a sulcal/gyral white matter pattern.
Croatian: Negativne snimke pokazuju sulkusni/giralni obrazac bijele tvari.
English: Radiation protection precautions in accordance with national regulations must be taken.
Croatian: Potrebno je poduzeti mjere opreza za zaštitu od zračenja u skladu s nacionalnim propisima.
English: The following adverse reactions may occur as symptoms and signs of a hypersensitivity reaction to VIZAMYL or any of its excipients (see section 6.1): eye/face swelling, pallor, dyspnoea, throat irritation, vomiting, rash, pruritus, skin tightness, chest tightness (see also section 4.4).
Croatian: Sljedeće nuspojave mogu se pojaviti kao simptomi i znakovi reakcije preosjetljivosti na VIZAMYL ili bilo koju pomoćnu tvar u lijeku (vidjeti dio 6.1): oticanje očiju/lica , bljedoća, dispneja, iritacija grla, povraćanje, osip, pruritus, zategnutost kože, napetost u prsištu (također vidjeti dio 4.4).
English: A pivotal study in 68 end-of-life patients was aimed at establishing the diagnostic performance of flutemetamol (18F) to detect the cortical neuritic plaque density.
Croatian: Ključno ispitivanje provedeno na 68 bolesnika na samrti bilo je usmjereno na utvrđivanje dijagnostičkog učinka flutemetamola (18F) u otkrivanju gustoće kortikalnih neuritičkih plakova.
English: Values were calculated assuming emptying of the urinary bladder at 3.5-hour intervals and human biodistribution data using OLINDA/EXM software.
Croatian: Vrijednosti su izračunate pomoću OLINDA/EXM programa uz pretpostavku pražnjenja mokraćnog mjehura u intervalima od 3,5 sata i uzimajući u obzir podatke o biodistribuciji u ljudi.
English: trgovina d.o.o Tel: + 386 2 4716300
Croatian: Biomedics M.B. trgovina d.o.o Tel: + 386 2 4716300
English: The reader should compare the cortical grey matter signal intensity to the maximum white matter signal intensity.
Croatian: Osoba koja tumači snimku mora usporediti intenzitet signala kortikalne sive tvari s maksimalnim intenzitetom signala bijele tvari.
English: The activity per vial may range from 400 MBq to 4000 MBq or from 400 MBq to 6000 MBq at the reference date and time.
Croatian: Aktivnost po bočici može iznositi od 400 MBq do 4000 MBq ili od 400 MBq do 6000 MBq na referentni datum i vrijeme.
English: The apparent elimination half-life is 4.5 hours whereas the radioactive half-life of flutemetamol (18F) is 110 minutes.
Croatian: Prividni poluvijek eliminacije iznosi 4,5 sata dok radioaktivni poluvijek flutemetamola (18F) iznosi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/941/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/941/002
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Croatian: Postupci primjene moraju se provoditi na način da se minimizira rizik od kontaminacije lijeka i ozračivanja osoba koje njime rukuju.
English: The use of VIZAMYL involves exposure to small amounts of radioactivity.
Croatian: Primjena lijeka VIZAMYL uključuje izlaganje malim količinama zračenja.
English: This product will only be handled and given to you by professionals who are trained and qualified to use it safely.
Croatian: Ovim lijekom rukovat će i primjenjivati ga stručne osobe koje su obučene i ovlaštene za njegovu sigurnu uporabu.
English: NAME OF THE MEDICINAL PRODUCT VIZAMYL 400 MBq/mL solution for injection
Croatian: NAZIV LIJEKA VIZAMYL 400 MBq/ml otopina za injekciju
English: Red marrow
Croatian: Navale crvenila
English: In two similar studies of biodistribution and a phase II clinical study, mean quantitative uptake values in PET images differed between pAD and HV subjects in most examined areas of the brain.
Croatian: U dva slična ispitivanja biodistribucije i kliničkom ispitivanju faze II srednje vrijednosti nakupljanja na PET snimkama razlikovale su se u ispitanika s potencijalnim ABom i zdravih dobrovoljaca u najčešće analiziranim dijelovima mozga.
English: A PET scan with flutemetamol (18F) should be requested by clinicians experienced in the clinical management of neurodegenerative disorders.
Croatian: PET snimanje s flutemetamolom (18F) trebali bi tražiti zdravstveni djelatnici s iskustvom u kliničkom liječenju neurodegenerativnih poremećaja.
English: VIZAMYL 400 MBq/mL solution for injection flutemetamol (18F)
Croatian: VIZAMYL 400 MBq/ml otopina za injekciju flutemetamol (18F)
English: Pharmacodynamic effects At the low concentrations present in VIZAMYL, flutemetamol (18F) has no detectable pharmacodynamic activity.
Croatian: Pri niskim koncentracijama prisutnim u VIZAMYL-u, flutemetamol (18F) nema zamjetnu farmakodinamičku aktivnost.
English: In vitro binding studies have not shown interference of flutemetamol (18F) binding to β-amyloid plaques in the presence of other common medicinal products taken by AD patients.
Croatian: In vitro ispitivanja vezivanja nisu pokazala interferenciju prilikom vezanja flutemetamola (18F) za β-amiloidne plakove uz prisutnost drugih uobičajenih lijekova koje uzimaju bolesnici s AB-om.
English: Treatment consists of increasing the passing of urine and stools in order to help remove radioactivity from your body.
Croatian: Ipak, u slučaju predoziranja primili biste odgovarajuće liječenje koje se sastoji od povećanja izlučivanja urina i stolice kako bi se omogućilo uklanjanje radioaktivnosti iz Vašeg tijela.
English: White matter - p pons and cc corpus callosum.
Croatian: Bijela tvar - p most i cc žuljevito tijelo.
English: If you have any further questions, ask your nuclear medicine doctor who will supervise your procedure.
Croatian: Ako imate dodatnih pitanja, obratite se svom liječniku specijalistu nuklearne medicine koji će nadgledati Vaš postupak.
English: Flutemetamol (18F) binds to β-amyloid neuritic plaques in the brain.
Croatian: Flutemetamol (18F) se veže za β-amiloidne neuritičke plakove u mozgu.
English: However, VIZAMYL may cause transient dizziness and vertigo.
Croatian: Ipak, VIZAMYL može uzrokovati prolaznu omaglicu i vrtoglavicu.
English: These adverse events are expected to occur with low probability.
Croatian: Očekuje se da je mogućnost pojave navedenih nuspojava mala.
English: MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finland ITEL Telecomunicazioni, Via Labriola (ZI, Lotto 40), 70037, Ruvo di Puglia, Italy Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, 01328 Dresden, Germany
Croatian: MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finska ITEL Telecomunicazioni, Via Labriola (ZI, Lotto 40), 70037, Ruvo di Puglia, Italija Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, 01328 Dresden, Njemačka
English: falling to 10 % at 180 minutes.
Croatian: 110 minuta.
English: A negative scan indicates none or a sparse density of cortical β-amyloid neuritic plaques.
Croatian: Negativni rezultat snimanja znači nepostojanje ili nisku gustoću kortikalnih β-amiloidnih neuritičkih plakova.
English: VIZAMYL contains alcohol (ethanol) and sodium VIZAMYL contains alcohol (ethanol).
Croatian: VIZAMYL sadrži alkohol (etanol) i natrij
English: VIZAMYL is a radioactive medicinal product that emits positrons, which annihilate with electrons to produce gamma rays, and must be handled with safety measures to minimise radiation exposure to clinical personnel and patients.
Croatian: VIZAMYL je radioaktivni lijek koji emitira pozitrone koji anihilacijom s elektronima stvaraju gama zrake te se njime mora rukovati oprezno kako bi se minimaliziralo izlaganje kliničkog osoblja i bolesnika zračenju.
English: The images should be viewed in a systematic manner (Figure 1) starting at the level of pons (p) and scrolling up through The frontal lobes and anterior cingulate (f, ac, axial review) Posterior cingulate and precuneus (pc, sagittal review) Temporo-parietal aspects including Insula (in, axial review and tp-in, coronal review) Lateral temporal lobes (lt, axial review) Striatal region (s, axial review)
Croatian: Snimke je potrebno pregledavati sistematično (Slika 1) počevši od razine mosta (p) prema gore kroz Frontalne režnjeve i prednji cingulatni korteks (f, ac, aksijalni prikaz) Stražnji cingulatni korteks i prekuneus (pc, sagitalni prikaz) Temporo-parijetalne dijelove uključujući inzulu (in, aksijalni prikaz i tp-in, koronalni prikaz) Lateralne temporalne režnjeve (It, aksijalni prikaz) Strijatalno područje (s, aksijalni prikaz)
English: This is equivalent to approximately 2% of the adult recommended maximum daily dietary intake for sodium These amounts may need to be considered for people on a low sodium diet.
Croatian: To odgovara približno 2% preporučenog maksimalnog dnevnog unosa natrija za odraslu osobu.
English: Excipients: ethanol anhydrous, polysorbate 80, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, water for injections.
Croatian: Pomoćne tvari: etanol bezvodni, polisorbat 80, natrijev klorid, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dodekahidrat, voda za injekcije.
English: VIZAMYL is supplied in a 10-mL or 15-mL glass vial.
Croatian: VIZAMYL se isporučuje u staklenim bočicama od 10 ml ili 15 ml.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT xx.x m L YYYY MBq at reference time.
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA xx,x ml GGGG MBq u referentno vrijeme.
English: VIZAMYL PET cases showing examples of negative flutemetamol (18F) PET scan (left) and positive scan (right).
Croatian: VIZAMYL PET slučajevi koji pokazuju primjere negativne PET snimke (lijevo) i pozitivne snimke (desno) s flutemetamolom (18F).
English: In a secondary analysis that used a standard of truth based on the region of maximum neuritic plaque involvement in the 3 neocortical regions originally recommended by CERAD, sensitivity was 92% (95% CI: 83% to 97%), and specificity was 88% (95% CI: 71% to 97%).
Croatian: U sekundarnoj analizi koja je koristila standard istine određen prema području maksimalne gustoće neuritičkih plakova u 3 neokortikalna područja, preporučena od CERAD-a osjetljivost je iznosila 92% (95% CI: 83% do 97%), a specifičnost 88% (95% CI: 71% do 97%).
English: When in doubt, it is important to consult the nuclear medicine doctor who will supervise the procedure.
Croatian: U slučaju bilo kakve sumnje, važno je posavjetovati se s liječnikom specijalistom nuklearne medicine koji će nadgledati postupak.
English: In vitro, flutemetamol (18F) binds to β-amyloid neuritic plaques in the brain, with negligible binding to neurofibrillary tangles.
Croatian: In vitro, flutemetamol (18F) se veže za β-amiloidne neuritičke plakove u mozgu, uz zanemarivo vezivanje na neurofibrilarne čvorove.
English: VIZAMYL images should only be interpreted by readers trained in the interpretation of PET images with flutemetamol (18F).
Croatian: Snimke dobivene pomoću VIZAMYL-a trebali bi tumačiti samo specijalisti educirani za tumačenje PET snimaka s flutemetamolom (18F).
English: In a re-reading study that increased the patient population of the pivotal study to include 38 additional autopsied patients (i.e., 106 in total), sensitivity and specificity for detection of moderate-frequent βamyloid neuritic plaque density in the primary analysis were 91% (95% CI: 82% to 96%) and 90% (95% CI: 74% to 98%), respectively, based on the majority read (i.e., the image interpretation reached by at least 3 of the 5 readers after electronic training).
Croatian: U ispitivanju u kojem je rađeno ponovno očitavanje povećana je populacija bolesnika u odnosu na ključno ispitivanje uključivanjem 38 dodatno obduciranih bolesnika (tj. ukupno 106), osjetljivost i specifičnost u utvrđivanju umjerene i učestale gustoće β-amiloidnih neuritičkih plakova u primarnim analizama je bila 91% (95% CI: 82% do 96%), odnosno 90% (95% CI: 74% do 98%), na temelju većine očitanja (tj. interpretacija slike od strane barem 3 od 5 tumača slika nakon elektronske obuke).
English: The pharmacokinetics of flutemetamol (18F) in patients with renal or hepatic impairment has not been characterised.
Croatian: Farmakokinetika flutemetamola (18F) u bolesnika s oštećenjem funkcije bubrega ili jetre nije okarakterizirana.
English: At the 36-month follow-up, 81 (35%) converted to clinical AD. Of the 97 aMCI patients who had a positive PET scan and at least one committee assessment, 52 (54%) were classified clinically as converted to clinical AD after 36 months compared to 29 (23%) of 127 who had a negative scan and at least one committee assessment.
Croatian: Od 97 s amnestičkim blagim kognitivnim oštećenjem koji su imali pozitivnu PET snimku i barem jednu procjenu odbora, u 52 (54%) je dijagnosticirana klinički AB nakon 36 mjeseci, u usporedbi s 29 (23%) od 127 koji su imali negativnu snimku i barem jednu procjenu odbora.
English: One multidose vial of 15-mL capacity contains 1 to 15 mL of solution, corresponding to 400 to 6000 MBq at reference date and time.
Croatian: Jedna višedozna bočica kapaciteta 15 ml sadrži 1 do 15 ml otopine, što odgovara 400 do 6000 MBq na referentni datum i vrijeme.
English: Breast-feeding It is not known whether flutemetamol (18F) is excreted in human milk during breast-feeding.
Croatian: Dojenje Nije poznato izlučuje li se flutemetamol (18F) u majčino mlijeko tijekom dojenja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for injection contains 400 MBq of flutemetamol (18F) at reference date and time.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaki ml otopine za injekciju sadrži 400 MBq flutemetamola (18F) na referentni datum i vrijeme.
English: One multidose vial of 10-mL capacity contains 1 to 10 mL of solution, corresponding to 400 to 4000 MBq at reference date and time.
Croatian: Jedna višedozna bočica kapaciteta 10 ml sadrži 1 do 10 ml otopine, što odgovara 400 do 4000 MBq na referentni datum i vrijeme.
English: VIZAMYL is for intravenous use.
Croatian: Način primjene VIZAMYL je namijenjen za intravensku primjenu.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted 17.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma
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 koristiti.
English: VIZAMYL is a radiopharmaceutical medicinal product 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: VIZAMYL je radiofarmaceutik indiciran za određivanje gustoće β-amiloidnih neuritičkih plakova pozitronskom emisijskom tomografijom (PET) u mozgu odraslih bolesnika s kognitivnim oštećenjima u kojih se sumnja na Alzheimerovu bolest (AB) ili neki drugi uzrok smanjenja kognitivnih sposobnosti.
English: Other medicines and VIZAMYL
Croatian: Drugi lijekovi i VIZAMYL
English: In the 68 patients, a blinded visual patient-level PET read by 5 blinded readers resulted in a majority read sensitivity of 86% (95% CI: 72% to 95%) and specificity 92% (95% CI: 74% to 99%).
Croatian: U 68 bolesnika, specifičan vizualni PET snimak bez poznavanja identiteta bolesnika očitan od strane 5 tumača slika rezultirao je osjetljivošću od 86% (95% CI: 72% do 95%) i specifičnošću od 92% (95% CI: 74% do 99%).
English: At 36 months, sensitivity of flutemetamol (18F) scans for predicting conversion from aMCI to AD in 81 converters was 64 % (95% CI: 54% to 75 %), specificity in 143 non-converters was 69% (95% CI: 60% to 76 %).
Croatian: Nakon 36 mjeseci, osjetljivost snimaka dobivenih pomoću flutemetamola (18F) u predviđanju progresije amnestičkog blagog kognitivnog oštećenja u Alzheimerovu bolest u 81 bolesnika iznosila je 64% (95% CI: 54% do 75%), specifičnost u 143 bolesnika koji nisu progredirali iznosila je 69% (95% CI: 60% do 76 %).
English: SHIELD LABEL / 15 mL
Croatian: NALJEPNICA NA ZAŠTITNOM PAKIRANJU / 15 ml
English: What VIZAMYL contains The active substance is flutemetamol (18F).
Croatian: Što VIZAMYL sadrži Djelatna tvar je flutemetamol (18F).
English: VIZAMYL should be used in conjunction with a clinical evaluation.
Croatian: VIZAMYL je potrebno primjenjivati uz odgovarajuću kliničku procjenu bolesnika.
English: The frequencies of adverse reactions are defined as follows:
Croatian: Učestalost nuspojava definirana je kako slijedi:
English: If you have any further questions on the use of this medicine, please ask your nuclear medicine doctor who supervises the procedure.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku specijalistu nuklearne medicine koji nadgleda postupak.
English: • Information on amyloid pathology in Alzheimer Disease; relevant information on VIZAMYL as an β-amyloid PET tracer, including the approved indication according to the SmPC, limitations of VIZAMYL use, interpretation errors, safety information and the results of clinical trials informing on the diagnostic use of VIZAMYL.
Croatian: • Informacije o amiloidnoj patologiji kod Alzheimerove bolesti; važne podatke o VIZAMYL-u kao β-amiloidnom PET obilježivaču, uključujući odobrene indikacije prema SmPC-u,