FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of flutemetamol (18F) for predicting development of AD or monitoring response to therapy has not been established (see section 5.1).
Croatian: Djelotvornost flutemetamola (18F) u predviđanju razvoja AB-a ili praćenju odgovora na liječenje nije ustanovljena (vidjeti dio 5.1).
English: No animal studies have been conducted to investigate the reproductive effects of flutemetamol (18F) (see section 5.3).
Croatian: Nisu provedena istraživanja na životinjama kako bi se proučili reproduktivni učinci flutemetamola (18F) (vidjeti dio 5.3).
English: The solution should then be withdrawn via the stopper, using either a single-dose syringe fitted with suitable protective shielding and a disposable sterile needle, or an authorised automated application system.
Croatian: Otopina zatim mora biti uvučena kroz čep, koristeći ili jednodoznu štrcaljku opremljenu prikladnom zaštitom i sterilnom iglom za jednokratnu primjenu, ili odobreni automatski sustav za primjenu.
English: If the administration is considered necessary, breast-feeding should be interrupted for 24 hours and the expressed feeds discarded.
Croatian: Ako je primjena nužna, dojenje je potrebno prekinuti na 24 sata te baciti izdojeno mlijeko.
English: This medicine is a radiopharmaceutical product for diagnostic use only.
Croatian: Ovaj lijek je radiofarmaceutik i koristi se samo u dijagnostičke svrhe.
English: EXPIRY DATE EXP: {hh:mm} {Time Zone} on {dd-mm-yyyy}
Croatian: EXP: {ss:mm} {Vremenska zona} {dd-mm-gggg}
English: If a CT scan is simultaneously performed as part of the PET procedure, exposure to ionising radiation will increase in an amount dependent on the settings used in the CT acquisition.
Croatian: Ako se CT snimka simultano provodi kao dio PET snimanja, izloženost ionizirajućem zračenju povećat će se ovisno o postavkama korištenim pri snimanju CT-a.
English: VIZAMYL is used to help diagnose Alzheimer's disease and other causes of memory loss.
Croatian: VIZAMYL se koristi u dijagnosticiranju Alzheimerove bolesti i drugih uzroka gubitka pamćenja.
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 patients and some neurodegenerative dementias (Alzheimer's disease, but also Lewy body dementia and Parkinson's disease dementia).
Croatian: Pozitivna snimka sama po sebi ne znači dijagnozu AB ili drugog kognitivnog poremećaja jer taloženje neuritičkih plakova u sivoj tvari može biti prisutno u asimptomatskih starijih bolesnika te nekih neurodegenerativnih demencija (Alzheimerova bolest, ali također i demencija s Lewyjevim tjelešcima i demencija kod Parkinsonove bolesti).
English: Do not use this medicine if you notice that the vial is damaged or the solution contains particulate matter or appears discoloured.
Croatian: Ne koristite ovaj lijek ako primijetite da je bočica oštećena ili da otopina sadrži čestice ili je promijenila boju.
English: If using an intravenous line, follow the injection with an intravenous flush of 5 mL to 15 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection to ensure full delivery of the dose.
Croatian: Ako se koristi venski put, nakon injekcije potrebno je provesti intravensko ispiranje s 5 ml do 15 ml sterilne 9 mg/ml (0,9%) otopine natrijevog klorida za injekciju kako bi se osigurala primjena cijele doze.
English: The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information.
Croatian: Pri svakoj primjeni, količina aktivnosti mora biti najmanja moguća za adekvatno prikupljanje željenih dijagnostičkih informacija.
English: Your nuclear medicine doctor may ask you to drink plenty of water before the start of the examination and the 24 hours after the study in order to urinate as often as possible to help remove it from your body faster.
Croatian: Vaš liječnik specijalist nuklearne medicine Vas može zatražiti da pijete puno vode prije početka postupka i tijekom 24 sata nakon postupka kako bi potaknuli učestalo mokrenje i olakšali uklanjanje lijeka iz tijela.
English: Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.
Croatian: Potrebno je pažljivo razmotriti korist i rizik u ovih bolesnika budući da postoji mogućnost povećanog izlaganja zračenju.
English: VIZAMYL should be used by, or under the control of, physicians who are qualified by specific training and experienced in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorised to license the use of radiopharmaceuticals.
Croatian: VIZAMYL smiju koristiti, ili njegovu primjenu moraju nadgledati, liječnici koji su posebno educirani i s iskustvom u sigurnoj uporabi i rukovanju radionuklidima te čije su iskustvo i edukacija potvrđeni od strane odgovarajuće nadležne institucije ovlaštene za davanje dozvola za uporabu radiofarmaceutika.
English: Flutemetamol (18F) was positive in in vitro genotoxicity tests in bacteria and mammalian cells but negative in three different in vivo studies with sufficiently high doses.
Croatian: Flutemetamol (18F) je bio pozitivan u in vitro testovima genotoksičnosti u bakterijama i stanicama sisavaca, ali negativan u tri različita in vivo ispitivanja s dovoljno visokim dozama.
English: 185 MBq the typical radiation dose to the target organ (brain) is 2.0 mGy.
Croatian: Za primijenjenu aktivnost od 185 MBq, tipična doza zračenja za ciljni organ (mozak) je 2,0 mGy.
English: Elimination and half-Life Flutemetamol (18F) is rapidly cleared from circulation (through the intestinal and urinary tracts).
Croatian: Eliminacija i poluvijek Flutemetamol (18F) se brzo eliminira iz cirkulacije (putem probavnog i mokraćnog sustava).
English: It is strongly recommended to review MR or CT images when available to aid interpretation of the VIZAMYL image, especially when atrophy is suspected.
Croatian: Preporučuje se pregled MR ili CT snimaka kada su dostupne u svrhu lakšeg tumačenja snimaka dobivenih pomoću VIZAMYL-a, osobito pri sumnji na atrofiju.
English: Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus.
Croatian: Postupci s radionuklidima koji se provode u trudnica rezultiraju i radioaktivnim zračenjem fetusa.
English: In AD patients, cortical regions and striatal regions show significantly greater uptake compared to cortical regions in controls.
Croatian: U bolesnika s ABom, kortikalna i strijatalna područja pokazuju značajno veće nakupljanje u usporedbi s kortikalnim područjima zdravih kontrolnih ispitanika.
English: Organ uptake Maximal flutemetamol (18F) brain uptake of approximately 7% of an injected dose occurs within two minutes of administration.
Croatian: Nakupljanje u organima Maksimalno nakupljanje flutemetamola (18F) u mozgu od otprilike 7% primijenjene doze događa se unutar dvije minute od primjene.
English: The solution should be inspected visually prior to use.
Croatian: Otopinu je prije uporabe potrebno vizualno provjeriti.
English: VIZAMYL images should be acquired starting 90 minutes after injection, using a PET scanner in 3D mode with appropriate data corrections.
Croatian: Snimke dobivene pomoću VIZAMYL-a potrebno je napraviti 90 minuta nakon injekcije, uporabom 3D PET snimača uz odgovarajuću korekciju podataka.
English: The injection of flutemetamol (18F) must be intravenous in order to avoid irradiation as a result of local extravasation, as well as imaging artefacts.
Croatian: Injekcija flutemetamola (18F) mora biti primijenjena intravenski kako bi se izbjeglo zračenje zbog lokalne ekstravazacije, kao i artefakti na snimkama.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where VIZAMYL is marketed, at launch and after launch, all physicians who are expected to use VIZAMYL have access to a training course in order to ensure accurate and reliable interpretation of the PET images.
Croatian: MAH treba osigurati da, nakon rasprava i dogovora s nadležnim državnim tijelom u svakoj državi članici u kojoj je VIZAMYL u prometu, prilikom i nakon stavljanja u promet, svi liječnici za koje se očekuje da će primjenjivati VIZAMYL imaju pristup obuci kako bi se osigurala točna i pouzdana interpretacija PET snimaka.
English: Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary.
Croatian: Potencijalne reakcije preosjetljivosti ili anafilaktičke reakcije Ako se razvije reakcija preosjetljivosti ili anafilaktička reakcija, primjenu lijeka potrebno je odmah prekinuti te, ako je potrebno, započeti simptomatsko intravensko liječenje.
English: The five organs/tissues with the highest cumulated activities were the wall of the small intestines, liver, urinary bladder wall, wall of the upper large intestine and the wall of the gallbladder.
Croatian: Pet organa/tkiva s najvišim kumuliranim aktivnostima bili su stijenka tankog crijeva, jetra, stijenka mokraćnog mjehura, stijenka gornjeg debelog crijeva i stijenka žučnog mjehura.
English: The PET results were compared with the neuritic plaque density measured on sections of eight predefined brain regions at the patient's autopsy.
Croatian: Rezultati PET snimanja su uspoređeni s gustoćom neuritičkih plakova izmjerenom na osam prethodno definiranih područja mozga pri obdukciji bolesnika.
English: It is given to adults with memory problems before they undergo a type of brain scan called a positron-emission tomography (PET) scan.
Croatian: Daje se odraslim osobama koje imaju poteškoće s pamćenjem prije početka snimanja mozga koje se naziva snimanje pozitronskom emisijskom tomografijom (PET snimanje).
English: Uncommon - may affect up to 1 in 100 people.
Croatian: Manje često - mogu se pojaviti u do 1 od 100 osoba.
English: It is hypothesized that solubility of the radiopharmaceutical in the lipid content of brain tissues may contribute to white matter retention.
Croatian: Pretpostavlja se da topljivost radiofarmaceutika u lipidnom sadržaju moždanog tkiva može pridonijeti zadržavanju u bijeloj tvari.
English: This medicinal product contains up to 41 mg (or 1.8 mmol) sodium per dose,equivalent to 2 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Ovaj lijek sadrži do 41 mg (ili 1,8 mmol) natrija po dozi, što odgovara 2% maksimalnog dnevnog unosa od 2 g natrija prema preporukama SZO za odraslu osobu.
English: The activity of flutemetamol (18F) has to be measured with a dose calibrator immediately prior to injection.
Croatian: Aktivnost flutemetamola (18F) potrebno je mjeriti kalibratorom doze neposredno prije primjene.
English: The estimated absorbed radiation doses for adults following intravenous injection of VIZAMYL are shown in Table 2.
Croatian: Procijenjene apsorbirane doze zračenja za odrasle osobe nakon intravenske injekcije VIZAMYL-a prikazane su u Tablici 2.
English: The adult effective dose resulting from the administration of a maximal recommended activity of 185 MBq dose for an adult weighing 70 kg is approximately 5.9 mSv.
Croatian: Efektivna doza za odrasle osobe koja rezultira primjenom maksimalne preporučene aktivnosti od 185 MBq po dozi za odraslu osobu težine 70 kg je otprilike 5,9 mSv.
English: EXPIRY DATE EXP: reference time +8 h
Croatian: ROK VALJANOSTI EXP: referentno vrijeme +8 h
English: 20 minutes post-injection, 75% of the radioactivity in plasma was present as polar metabolites.
Croatian: Dvadeset minuta nakon primjene, 75% radioaktivnosti u plazmi bilo je prisutno u obliku polarnih metabolita.
English: Due to the small quantity of flutemetamol (18F) in each dose, overdose is not expected to result in pharmacological effects.
Croatian: Zbog male količine flutemetamola (18F) u svakoj dozi ne očekuju se farmakološki učinci predoziranja.
English: Flutemetamol (18F) is distributed throughout the body within several minutes of injection.
Croatian: Flutemetamol (18F) se u organizmu distribuira unutar nekoliko minuta nakon injekcije.
English: What VIZAMYL is and what it is used for What you need to know before VIZAMYL is used How VIZAMYL is used
Croatian: Što je VIZAMYL i za što se koristi Što morate znati prije nego primite VIZAMYL
English: Table 1 List of adverse reactions System Organ Class
Croatian: Tablica 1 Popis nuspojava Klasifikacija organskih sustava
English: After 20 minutes approximately 20 % of the active compound flutemetamol (18F) remains in the circulation,
Croatian: Nakon 20 minuta, otprilike 20% djelatne tvari flutemetamola (18F) ostaje u cirkulaciji, a nakon 180 minuta
English: Table 2 Estimated radiation absorbed doses from intravenous injection of VIZAMYL (adults)
Croatian: Tablica 2 Procijenjene apsorbirane doze zračenja od intravenske injekcije VIZAMYL-a (odrasli)
English: What you need to know before VIZAMYL is used
Croatian: Što morate znati prije nego primite VIZAMYL
English: • The material should include VIZAMYL PET demonstration cases with correct PET scan interpretation by an experienced reader; VIZAMYL-PET scans for self-assessment; and a selfqualification procedure to be offered to each trainee.
Croatian: • Matrijal treba uključivati VIZAMYL PET pokazne slučajeve s točnim tumačenjem PET snimka od strane iskusnog tumača; VIZAMYL PET snimke za samoprocjenu; i samokvalifikacijski postupak koji treba biti ponuđen svakoj osobi koja je podvrgnuta obuci.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: U svakoj grupi po učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: Serious side effects Tell your doctor straight away, if you notice any of the following, as you may need urgent medical treatment: Allergic reactions - the signs may include swelling of your face or eyes, having pale, itchy or tight skin or having a rash, feeling short of breath, tightness in the chest, irritation in your throat or being sick.
Croatian: Ozbiljne nuspojave Odmah obavijestite svog lječnika, ako primijetite bilo što od sljedećeg, jer možda trebate hitno liječenje: Alergijske reakcije - znakovi mogu uključivati oticanje lica ili očiju, bljedilo, svrbež, ili zatezanje kože ili osip, nedostatak zraka, stezanje u prsnom košu, nadraženost grla ili povraćanje.
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 breastfeeding, and to the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk.
Croatian: Prije primjene radiofarmaceutika u dojilje potrebno je razmotriti mogućnost odgode primjene radionuklida do prestanka dojenja te izabrati najprikladniji radiofarmaceutik imajući u vidu njegovo izlučivanje u majčino mlijeko.
English: You must stop breast-feeding for 24 hours after the injection.
Croatian: Morate prestati dojiti 24 sata nakon injekcije.
English: Pharmacodynamic drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medicinal products may alter VIZAMYL image results.
Croatian: Nisu provedena ispitivanja farmakodinamičkih interakcija lijekova na bolesnicima kako bi se utvrdio opseg, ako postoji, u kojem istovremeno uzeti lijekovi mogu utjecati na rezultate snimaka dobivenih pomoću VIZAMYL-a.
English: For an administered activity of 185 MBq the typical radiation doses delivered to the critical organs, gallbladder, urinary bladder wall, upper large intestine wall, lower large intestine wall, small intestine and liver are 53.1 mGy, 26.8 mGy, 21.6 mGy, 7.8 mGy, 18.9 mGy and 10.5 mGy, respectively.
Croatian: Za primijenjenu aktivnost od 185 MBq tipične doze zračenja isporučene kritičnim organima, žučnom mjehuru, stijenci mokraćnog mjehura, stijenci gornjeg dijela debelog crijeva, stijenci donjeg dijela debelog crijeva, stijenci tankog crijeva i jetri su, redom, 53,1 mGy, 26,8 mGy, 21,6 mGy, 7,8 mGy, 18,9 mGy i 10,5 mGy.
English: The biophysical basis of the white matter retention of flutemetamol (18F) in the living human brain has not been definitively explained.
Croatian: Biofizička osnova zadržavanja flutemetamola (18F) u bijeloj tvari u živom ljudskom mozgu nije u potpunosti objašnjena.
English: Feeling abnormal Feeling cold Infusion site pain Oedema
Croatian: Abnormalan osjećaj Osjećaj hladnoće Bol na mjestu infuzije Edem
English: The in vivo binding of flutemetamol (18F) to other β-amyloid structures or other brain structures or receptors remains unknown.
Croatian: In vivo vezanje flutemetamola (18F) s drugim β-amiloidnim strukturama ili drugim strukturama mozga ili receptorima je nepoznato.
English: β-Amyloid plaques are deposits sometimes present in the brains of people with dementias (such as Alzheimer's disease).
Croatian: Nakupine β-amiloida su naslage koje se mogu naći u mozgu ljudi koji boluju od demencije, tj. imaju poteškoća s pamćenjem (poput Alzheimerove bolesti).
English: Sensitivity and specificity to estimate β-amyloid deposition of flutemetamol (18F) was further investigated in one additional study, in which a different set of 5 electronically-trained blinded readers interpreted images from the same 68 patients followed to autopsy in the pivotal study.
Croatian: Osjetljivost i specifičnost procjene β-amiloidnih depozita pomoću flutemetamola (18F) je nadalje proučavana u jednom dodatnom ispitivanju, u kojem je 5 različitih elektronski-obučenih tumača slika bez poznavanja njihovog identiteta interpretiralo slike od istih 68 bolesnika nakon obdukcije u ključnom ispitivanju.
English: The recommended activity for an adult is 185 MBq of flutemetamol (18F) administered intravenously
Croatian: Preporučena aktivnost za odraslu osobu iznosi 185 MBq flutemetamola (18F) primijenjena intravenski
English: Image interpretation errors in the estimation of brain β-amyloid neuritic plaque density, including false negatives and false positives, have been observed.
Croatian: Zabilježene su pogreške u tumačenju gustoće β-amiloidnih neuritičkih plakova u mozgu, uključujući lažno negativne i lažno pozitivne rezultate.
English: You must inform the nuclear medicine doctor before you are given VIZAMYL 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 specijalista nuklearne medicine prije nego primite VIZAMYL ako postoji mogućnost da ste trudni, ako niste dobili mjesečnicu ili ako dojite.
English: Healthy controls show low levels of flutemetamol (18F) retention in cerebral cortex.
Croatian: Zdravi kontrolni ispitanici pokazuju niske razine zadržavanja flutemetamola (18F) u cerebralnom korteksu.
English: The effective dose is approximately 5.9 mSv when the maximal recommended activity of 185 MBq of flutemetamol (18F) is administered.
Croatian: Učinkovita doza iznosi otprilike 5,9 mSv pri primjeni maksimalne preporučene aktivnosti od 185 MBq flutemetamola (18F).
English: Some scans may be difficult to interpret due to image noise, atrophy with a thinned cortical ribbon or image blur, which could lead to interpretation errors.
Croatian: Neke snimke može biti teško tumačiti zbog šuma na snimci, atrofije sa stanjenim kortikalnim slojem, ili zamućenja snimke što može dovesti do pogrešaka u tumačenju.
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 slučaju kada postoji nesigurnost u vezi lokacije sive tvari i granice između sive i bijele tvari na PET snimci, a dostupna je nedavna CT ili MR snimka, osoba koja tumači snimku bi trebala pregledati fuzionirane PET-CT ili PET-MR snimke u svrhu razjašnjenja odnosa između PET radioaktivnosti i anatomije sive tvari.
English: In AD patients, as in controls, there is high retention in pons and other white matter areas.
Croatian: Kod bolesnika a AB-om, kao i u zdravih kontrolnih ispitanika, postoji značajno zadržavanje u mostu i drugim područjima bijele tvari.
English: Dizziness Headache Hypoaesthesia Hypotonia Dysgeusia Tremor
Croatian: Omaglica Glavobolja Hipoestezija Hipotonija Disgeuzija Tremor
English: Note that the intensity is higher (> 60% of max) in the grey matter regions of the positive images compared to the negative images and that the intensity radiates to a sharply defined convex edge in the lateral aspects.
Croatian: (> 60% od maksimalnog) u područjima sive tvari na pozitivnim snimkama u usporedbi s negativnim snimkama i da intenzitet zrači do oštro definiranog konveksnog ruba u lateralnom aspektu.
English: Brain uptake and distribution of flutemetamol (18F) were not evaluated in a specific study aimed to evaluate pharmacodynamics.
Croatian: Nakupljanje u mozgu i distribucija flutemetamola (18F) nisu procjenjivani u posebnom ispitivanju s ciljem procjene farmakodinamike.
English: Interpretation of the images is performed visually by comparing the activity in cortical grey matter with activity in adjacent cortical white matter.
Croatian: Tumačenje snimaka se provodi vizualno uspoređujući aktivnost kortikalne sive tvari s aktivnošću susjedne kortikalne bijele tvari.
English: back pain feeling hot or cold increased breathing rate pain at the injection site heart pounding (palpitations) pain in muscles or bones shaking movements (tremor) puffy and swollen skin fever over breathing (hyperventilation) change in the way you taste things a spinning feeling (vertigo) reduced sense of touch or sensation feeling tired or weak inability to get or maintain an erection indigestion, stomach ache or sore mouth vomiting decreased feeling or sensitivity especially in your skin or your face increase in “blood lactate dehydrogenase” or “neutrophils” in blood tests skin tightness
Croatian: Možete iskusiti sljedeće manje česte nuspojave: glavobolja omaglica tjeskoba mučnina nelagoda u prsištu niska razina šećera u krvi (simptomi: glad, glavobolja) bol u leđima osjećaj vrućine ili hladnoće ubrzano disanje bol na mjestu primjene lijeka osjećaj lupanja srca (palpitacije) bol u mišićima ili kostima nevoljno drhtanje (tremor) nabreknuta i natečena koža vrućica brzo i duboko disanje (hiperventilacija) promjena osjeta okusa vrtoglavica (vertigo) smanjen osjećaj dodira ili osjeta osjećaj umora ili slabosti nesposobnost postizanja ili održavanja erekcije probavne tegobe, bol u trbuhu ili bol u ustima povraćanje smanjen osjet ili osjetljivost, posebno na koži ili na licu krvnim pretragama otkriveno povećanje razine laktat dehidrogenaze u krvi ili neutrofila zategnutost kože
English: What VIZAMYL looks like and contents of the pack VIZAMYL is a clear, colourless to slightly yellow solution for injection.
Croatian: Kako VIZAMYL izgleda i sadržaj pakiranja VIZAMYL je bistra, bezbojna do blago žuta otopina za injekciju.
English: To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease or epilepsy.
Croatian: O tome treba voditi računa u trudnica ili dojilja te u visokorizičnih skupina bolesnika poput onih s bolestima jetre ili epilepsijom.
English: Key: Grey matter - f frontal and ac anterior cingulate, pc posterior cingulate and precuneus, lt lateral temporal, tp temporo-parietal and in insula and and s striatum.
Croatian: Oznake: siva tvar - f frontalno i ac prednje cingulatno, pc stražnje cingulatno i prekuneus, lt lateralno temporalno, tp temporo-parijetalno i in insula i s strijatum.
English: AAA, Colleretto Giacosa (TO) Advanced Accelerator Applications S.r.l.
Croatian: AAA, Colleretto Giacosa (TO) Advanced Accelerator Applications S.r.l. Via Ribes 5
English: VIZAMYL may cause transient dizziness or vertigo, which may affect your ability to drive or use machines.
Croatian: VIZAMYL može uzrokovati prolaznu omaglicu ili vrtoglavicu, što može utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima.