FrancophonIA/ELRC3.0 huggingface dataset:
English: Children and adolescents VIZAMYL is not intended for use in children and adolescents below the age of 18 years old.
Croatian: Djeca i adolescenti VIZAMYL nije namijenjen za primjenu kod djece i adolescenata mlađih od 18 godina.
English: Appropriate aseptic precautions should be taken.
Croatian: Potrebno je poduzeti odgovarajuće aseptične mjere opreza.
English: 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) and not known (cannot be estimated from the available data).
Croatian: Vrlo često (≥1/10), često (≥1/100 do <1/10), manje često (≥1/1000 do <1/100), rijetko (≥1/10 000 do <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Limitations of use
Croatian: Ograničenja pri uporabi
English: If any one of these regions is clearly positive (abnormal) then the image should be classified as positive (abnormal).
Croatian: Ako je bilo koje od tih područja jasno pozitivno (abnormalno), snimku bi trebalo klasificirati kao pozitivnu (abnormalnu).
English: There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Croatian: Postoje strogi zakoni o uporabi, rukovanju i odlaganju radiofarmaceutskih proizvoda.
English: Organ/Tissue
Croatian: Organ/Tkivo
English: Based on the majority read, the positive and negative likelihood ratios were 2.04 and 0.52 respectively.
Croatian: Na temelju većine očitanja, pozitivni i negativni omjeri vjerojatnosti iznosili su približno 2,04 i 0,52.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek, jer sadrži Vama važne podatke.
English: Megabecquerel (MBq) is the unit used to measure radioactivity.
Croatian: Megabekerel (MBq) je jedinica koja se koristi za mjerenje radioaktivnosti.
English: Nucleis SA Allée du Six-Août, 8 4000 Liège Belgium
Croatian: Nucleis SA Allée du Six-Août, 8 4000 Liège Belgija
English: This is followed by rapid clearance from the brain in the first 90 minutes (the recommended time to start scanning), followed by more gradual clearance.
Croatian: Nakon toga slijedi brzo izlučivanje iz mozga u prvih 90 minuta (preporučeno vrijeme za početak snimanja), praćeno naknadnim sporijim izlučivanjem.
English: Date of first authorisation: 22 August 2014 Date of latest renewal: 25 July 2019
Croatian: Datum posljednje obnove odobrenja: 25. srpnja 2019.
English: Each dose contains up to 552 mg alcohol.
Croatian: Svaka doza sadrži do 552 mg alkohola.
English: You should not drive, use machines or engage in other potentially hazardous activities until these effects have completely disappeared.
Croatian: Nemojte voziti, upravljati strojevima ili obavljati druge potencijalno opasne aktivnosti dok ovi učinci u potpunosti ne nestanu.
English: The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting etc.
Croatian: Primjena radiofarmaceutika stvara rizik za druge osobe od vanjskog zračenja ili kontaminacije kapljicama urina, povraćanjem itd.
English: To enable immediate action in emergencies the necessary medicinal products and equipment such as endotracheal tube and ventilator must be readily available.
Croatian: Kako bi se omogućilo neposredno djelovanje u hitnim slučajevima, moraju biti dostupni potrebni lijekovi i oprema, poput endotrahealnog tubusa i samoširećeg balona (ventilatora).
English: Any clinically relevant mutagenic potential is therefore considered highly unlikely.
Croatian: Stoga se smatra da je vjerojatnost klinički značajnog mutagenog potencijala vrlo mala.
English: Nr. 482/2 EZ98 KG 2444 Seibersdorf Austria
Croatian: Nr. 482/2 EZ98 KG 2444 Seibersdorf Austrija
English: The nuclear medicine doctor supervising the procedure will decide on the amount of VIZAMYL to be used in your case.
Croatian: Liječnik specijalist nuklearne medicine koji nadgleda postupak odlučiti će o količini VIZAMYL-a koja će se koristiti u Vašem slučaju.
English: There is no relevant use of VIZAMYL in the paediatric population.
Croatian: Nema relevantne primjene VIZAMYL-a u pedijatrijskoj populaciji.
English: Common - may affect up to 1 in 10 people looking flushed increased blood pressure
Croatian: Često - mogu se pojaviti u do 1 od 10 osoba crvenilo povišeni krvni tlak
English: Via Labriola (Zona industriale Lotto 40), SNC 70037, Ruvo di Puglia (BA) Italy
Croatian: Via Labriola (Zona industriale Lotto 40), SNC 70037, Ruvo di Puglia (BA) Italija
English: If you have received more VIZAMYL than you should An overdose is unlikely since you will only receive a single dose of VIZAMYL from the nuclear medicine doctor under controlled conditions.
Croatian: Ako primite više VIZAMYL-a nego što ste trebali Predoziranje nije vjerojatno jer ćete primiti samo jednu dozu VIZAMYL-a od liječnika specijalista nuklearne medicine u kontroliranim uvjetima.
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 advice before you are given this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku specijalistu nuklearne medicine za savjet prije nego uzmete ovaj lijek.
English: Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus.
Croatian: Zbog toga je tijekom trudnoće potrebno provoditi samo nužne pretrage, pri kojima je vjerojatna korist znatno veća od potencijalnog rizika za majku i fetus.
English: The vials must not be opened before disinfecting the stopper.
Croatian: Bočice se ne smiju otvoriti prije dezinficiranja čepa.
English: Please refer to the SmPC {SmPC should be included in the box}.
Croatian: Pogledajte SmPC {SmPC se treba nalaziti u kutiji}.
English: Express the breast milk during this period and discard any breast milk you have expressed.
Croatian: Izdojite mlijeko tijekom ovog perioda i bacite svo izdojeno mlijeko.
English: Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Croatian: Njihovo preuzimanje, čuvanje, primjena, prijenos i zbrinjavanje podložni su propisima i/ili određenim dozvolama nadležnog službenog tijela.
English: For each patient, the radiation exposure must be justified by the likely benefit.
Croatian: Za svakog bolesnika izlaganje zračenju mora biti opravdano vjerojatnom korišću.
English: Pharmacotherapeutic group: diagnostic radiopharmaceutical, central nervous system, ATC code: V09AX04
Croatian: Farmakoterapijska skupina: dijagnostički radiofarmaceutik, središnji živčani sustav, ATK oznaka: V09AX04
English: The histopathology regions included, but were not restricted to the CERAD regions.
Croatian: Histopatološka područja su uključivala, ali nisu bila ograničena na CERAD (eng.
English: Do not use this medicine after the expiry date and time, which are stated on the label after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka datuma i vremena roka valjanosti navedenih na naljepnici iza ‘EXP'.
English: Of the 232 patients enrolled, 224 had at least one post-scan review by the independent committee and were included in the analysis.
Croatian: Od 232 uključena bolesnika, 224 su imala barem jednu procjenu nakon snimanja od strane nezavisnog odbora i uključeni su u analizu.
English: The dose is administered by intravenous bolus injection within approximately 40 seconds.
Croatian: Doza se primjenjuje intravenskom bolus injekcijom unutar otprilike 40 sekundi.
English: The following adverse reactions are listed in the Table 1 below:
Croatian: Sljedeće nuspojave prikazane su u Tablici 1 u nastavku:
English: You should discuss the results of the test with the doctor that requested the scan.
Croatian: Rezultate testa trebali biste raspraviti s liječnikom koji je tražio snimanje.
English: Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Croatian: Vaš liječnik specijalist nuklearne medicine informirat će Vas o uobičajenom trajanju postupka.
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 these small amounts of radiation.
Croatian: Vaš liječnik i liječnik specijalist nuklearne medicine smatraju da je klinička korist ovog postupka s primjenom radiofarmaceutika veća od rizika izlaganja malim količinama zračenja.
English: The nuclear medicine doctor will only give this medicine during pregnancy if a benefit is expected which would outweigh the risks.
Croatian: Liječnik specijalist nuklearne medicine ovaj će lijek primijeniti tijekom trudnoće isključivo ako se očekuje korist koja će nadmašiti rizike.
English: Volume: xx.x mL
Croatian: Volumen: xx,x ml
English: Note also the medial regions where higher levels of intensity in the grey matter are seen in the positive images on the right.
Croatian: Uočite također središnja područja u kojima se vidi viša razina intenziteta u sivoj tvari na pozitivnim snimkama na desnoj strani.
English: • Review of the PET reading criteria, including method of image review, criteria for interpretation, and images demonstrating the binary read methodology.
Croatian: • Pregled kriterija očitavanja PET-a, uključujući metodu pregleda slike, kriterij za tumačenje i slike koje pokazuju ‘binary read' metodologiju.
English: The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine.
Croatian: Liječnik specijalist nuklearne medicine obavijestit će Vas trebate li poduzeti neke posebne mjere opreza nakon primanja ovog lijeka.
English: As a result of the manufacturing process some vials are distributed with punctured rubber stoppers.
Croatian: Kao rezultat proizvodnog postupka, neke bočice distribuiraju se s probušenim gumenim čepovima.
English: Each vial is stored in a container.
Croatian: Svaka bočica nalazi se u spremniku.
English: This 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: Ovo snimanje, uz druge testove ispitivanja funkcije mozga, može pomoći Vašem liječniku u određivanju imate li ili ne nakupine βamiloida u Vašem mozgu.
English: Advanced Accelerator Applications Technopole de l'Aube 14 rue Gustave Eiffel 10430 Rosières près Troyes France
Croatian: Advanced Accelerator Applications Technopole de l'Aube 14 rue Gustave Eiffel 10430 Rosières près Troyes Francuska
English: Paediatric population For information on the use in the paediatric population, see sections 4.2 or 5.1.
Croatian: Pedijatrijska populacija Za informacije o primjeni u pedijatrijskoj populaciji pogledajte dijelove 4.2 ili 5.1.
English: Elimination of flutemetamol (18F) is approximately 37% renal and 52% hepatobiliary.
Croatian: Eliminacija flutemetamola (18F) je otprilike 37% renalnim putem i 52% hepatobilijarnim putem.
English: When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant.
Croatian: Kada se radiofarmaceutik namjerava primijeniti u žene generativne dobi važno je utvrditi je li trudna ili nije.
English: ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PRILOG II. A. PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
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 stavljanja u promet u svakoj državi članici nositelj odobrenja za stavljanje lijeka u promet (MAH) treba dogovoriti dodatni edukacijski program s nadležnim državnim tijelom.
English: Summary of the safety profile The overall safety profile of VIZAMYL is based on data from its administrations to 831 subjects.
Croatian: Sažetak sigurnosnog profila Ukupni sigurnosni profil VIZAMYL-a temelji se na podacima primjene na 831 ispitaniku.
English: Expertise and qualification of trainers in both electronic and in-person training should be ensured.
Croatian: Potrebno je osigurati stručnost i kvalifikacije trenera u elektronskom te osobnom obučavanju.
English: Remaining organs Effective dose (mSv/MBq)
Croatian: Efektivna doza (mSv/MBq)
English: This medicinal product contains (7 vol %) of ethanol (alcohol), i.e. up to 552 mg (approximately 0.7 mL) per dose.
Croatian: Ovaj lijek sadrži (7 vol %) etanola (alkohola), tj. do 552 mg (otprilike 0,7 ml) po dozi.
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 je pažljivo razmotriti količinu aktivnosti pri primjeni budući da u ovih bolesnika postoji mogućnost povećanog izlaganja zračenju (vidjeti dio 4.4).
English: No dose adjustment is recommended based on age.
Croatian: Prilagodba doze s obzirom na dob nije preporučena.
English: 98 (42%) of the 232 patients had abnormal (positive) flutemetamol (18F) scans.
Croatian: Devedeset osam (42%) od 232 bolesnika je imalo abnormalne (pozitivne) snimke dobivene pomoću flutemetamola (18F).
English: Method of preparation The package must be checked before use and the activity measured using a dose calibrator.
Croatian: Način pripreme Pakiranje mora biti provjereno prije uporabe te aktivnost izmjerena pomoću kalibratora doze.
English: Only clear solutions, free of visible particles should be used.
Croatian: Smiju se koristiti samo bistre otopine, bez vidljivih čestica.
English: This radiopharmaceutical will deliver low amounts of ionising radiation, which is associated with very low risk of cancer and hereditary abnormalities (passing on faulty genes).
Croatian: Ovaj radiofarmaceutik isporučit će male količine ionizirajućeg zračenja koje je povezano s vrlo niskim rizikom od raka i nasljednih poremećaja (prenošenje neispravnih gena).
English: Histopathology from the pivotal study was used.
Croatian: Upotrebljena je histopatologija iz ključnog ispitivanja.
English: This could be harmful for people with alcoholism and needs to be taken into account in pregnant or breast-feeding women and people with liver problems or epilepsy.
Croatian: To može biti štetno za osobe koje boluju od alkoholizma i mora se uzeti u obzir kod trudnica ili dojilja te osoba koje imaju probleme s jetrom ili epilepsiju.
English: Fertility No studies on fertility have been performed.
Croatian: Plodnost Nisu provedena istraživanja plodnosti.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements (see section 6.6).
Croatian: Nekorišten lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima (vidjeti dio 6.6).
English: If in doubt about her potential pregnancy (if the woman has missed a period, if the period is irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient.
Croatian: Ako postoji nedoumica u vezi njene potencijalne trudnoće (ako je izostala mjesečnica, ako je mjesečnica neredovita, itd.) potrebno je bolesnici ponuditi alternativne dijagnostičke postupke koji ne uključuju ionizirajuće zračenje (ako postoje).
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: Fluorin (18F) se raspada na stabilni kisik (18O) s poluvijekom od otprilike 110 minuta, emitirajući pozitronsko zračenje od 634 keV, nakon čega slijedi fotonsko anihilacijsko zračenje od 511 keV.
English: What VIZAMYL is and what it is used for
Croatian: Što je VIZAMYL i za što se koristi
English: Each mL of solution contains 55.2 mg of ethanol and 4.1 mg of sodium.
Croatian: Svaki ml otopine sadrži 55,2 mg etanola i 4,1 mg natrija.
English: Extensive dose-range and adjustment studies with the medicinal product in normal and special populations have not been performed.
Croatian: Nisu provedena detaljna ispitivanja o rasponu doze i prilagodbi doze kod normalne i posebnih populacija.
English: These are uncommon side effects and may affect up to 1 in 100 people.
Croatian: To su manje česte nuspojave i mogu se javiti u do 1 od 100 osoba.
English: Radioactive medicine
Croatian: Radioaktivni lijek
English: 47014 Meldola (FC) Italy
Croatian: 47014 Meldola (FC) Italija
English: The highest level of uptake is in pons and other white matter regions.
Croatian: Najviša razina nakupljanja je u mostu i drugim područjima bijele tvari.
English: Therefore, following the administration of VIZAMYL, patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until these effects have completely disappeared.
Croatian: Zbog toga se, nakon primjene VIZAMYL-a, bolesnicima savjetuje da ne upravljaju vozilima, složenim strojevima te da ne sudjeluju u drugim potencijalno opasnim aktivnostima dok ovi učinci u potpunosti ne nestanu.
English: Injection of VIZAMYL through a short intravenous catheter (approximately 12.5 cm or less) minimises the potential for adsorption of the active substance to the catheter.
Croatian: Primjena VIZAMYL-a putem kratkog intravenskog katetera (dužine otprilike 12,5 cm ili manje) minimalizira potencijal za adsorpciju djelatne tvari na kateter.
English: Flutemetamol (18F) must not be diluted.
Croatian: Flutemetamol (18F) se ne smije razrjeđivati.
English: For the limitations of use in patients with mild cognitive impairment (MCI), see section 5.1.
Croatian: Za ograničenja pri uporabi kod bolesnika s blagim kognitivnim oštećenjem (MCI, eng. mild cognitive impairment) vidjeti dio 5.1.
English: The usual amount recommended for an adult is 185 MBq.
Croatian: Uobičajena preporučena količina za odraslu osobu je 185 MBq.
English: Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Croatian: Svaku ženu kojoj je izostala mjesečnica treba smatrati trudnom dok se ne dokaže suprotno.
English: The negative images show a tapered intensity to the periphery of the tissue.
Croatian: Negativne snimke pokazuju intenzitet koji se sužava prema periferiji tkiva.
English: Atrophy may be present in many areas of the brain and may render image interpretation more difficult as loss of grey matter will result in reduced tracer uptake making a positive scan more difficult to recognise.
Croatian: Atrofija može biti prisutna u mnogim područjima mozga i otežati tumačenje snimaka budući da gubitak sive tvari rezultira smanjenim nakupljanjem obilježivača zbog čega prepoznavanje pozitivne snimke može biti teže.
English: Radiopharmaceuticals should be prepared in a manner that satisfies both radiation safety and pharmaceutical quality requirements.
Croatian: Radiofarmaceutici se moraju pripremati na način koji zadovoljava sigurnost kod zračenja i zahtjeve farmaceutske kvalitete.
English: PET images should be read using a Sokoloff, Rainbow or Spectrum colour scale.
Croatian: Pri tumačenju PET snimaka potrebno je koristiti Sokoloff, Rainbow ili Spectrum ljestvicu.
English: VIZAMYL must not be used: If you are allergic to flutemetamol (18F) or any of the other ingredients of this medicine (listed in section 6).
Croatian: VIZAMYL se ne smije primijeniti: ako ste alergični na flutemetamol (18F) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: At 180 minutes, 90% of the radioactivity was present in plasma in the form of polar metabolites.
Croatian: Nakon 180 minuta, 90% radioaktivnosti u plazmi bilo je prisutno u obliku polarnih metabolita.
English: The European Medicines Agency has waived the obligation to submit the results of studies with flutemetamol (18F) in all subsets of the paediatric population as the disease or condition for which the specific medicinal product is intended only occurs in adults (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka flutemetamol (18F) u svim podskupinama pedijatrijske populacije jer se stanje ili bolest kojima je određeni lijek namijenjen događa samo u odraslih (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Signal will not be completely absent in grey matter regions of the images, as white matter binding in adjacent regions will bleed into the grey matter regions due to PET partial volume resolution effects.
Croatian: Signal neće biti potpuno odsutan u područjima sive tvari na snimkama jer će se spoj bijele tvari u susjednim područjima pretopiti u područja sive tvari zbog učinaka parcijalne rezolucije volumena na PETu.
English: The complete SmPC of VIZAMYL 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: Cijeli sažetak opisa svojstava lijeka (SmPC) VIZAMYL isporučuje se kao zasebni dokument u pakiranju lijeka, s ciljem pružanja dodatnih znanstvenih i praktičnih informacija o primjeni i uporabi ovog radiofarmaceutika zdravstvenim djelatnicima.
English: The patient should be encouraged to void prior to and following imaging with VIZAMYL, and frequently thereafter for the next 24 hours.
Croatian: Bolesnika treba potaknuti na mokrenje prije i nakon snimanja VIZAMYL-om, i često nakon njega tijekom sljedeća 24 sata.
English: A brain scan is usually taken 90 minutes after VIZAMYL is given.
Croatian: Snimanje mozga obično traje oko 90 minuta nakon primjene VIZAMYL-a.
English: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.
Croatian: Radiofarmaceutike smije preuzeti, koristiti i primjenjivati samo ovlašteno osoblje u za to namijenjenim kliničkim uvjetima.
English: VIZAMYL contains a maximum of 41 mg of sodium (main component of cooking/table salt) in each dose.
Croatian: VIZAMYL sadrži maksimalno 41 mg natrija (glavni sastojak kuhnjske soli) u jednoj dozi.
English: Activity: 400 MBq/mL at {hh:mm} {Time Zone} on {dd-mm-yyyy} Activity: YYYY MBq {at hh:mm} {Time Zone} on {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: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Croatian: Izlaganje ionizirajućem zračenju povezano je s nastajanjem raka i potencijalnim razvojem nasljednih mana.
English: See special handling precautions in section 6.6.
Croatian: Pogledajte posebne mjere opreza pri rukovanju u dijelu 6.6.
English: The sulcal and gyral pattern is not discernible in the positive images on the right.
Croatian: Sulkusni i giralni obrazac nije primijećen na pozitivnim snimkama na desnoj strani.
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 images obtained from the brain scan.
Croatian: Obavijestite svog liječnika specijalista nuklearne medicine ako uzimate, ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove jer to može utjecati na rezultate dobivene snimanjem mozga.
English: Table 2 below shows the dosimetry as calculated using the OLINDA/EXM (Organ Level INternal Dose Assessment/Exponential Modeling) software.
Croatian: Tablica 2 u nastavku prikazuje dozimetriju izračunatu uporabom OLINDA/EXM (Organ Level INternal Dose Assessment/Exponential