natgillin/translations-raw huggingface dataset:
• 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;
• informacije o amiloidozi pri Alzheimerjevi bolezni; • relevantne informacije o zdravilu Neuraceq kot β-amiloidnem PET-označevalcu, vključno z odobreno indikacijo v skladu s Povzetkom glavnih značilnosti zdravila, omejitvami glede uporabe zdravila Neuraceq, napakami pri interpretaciji, informacijami o varnosti in rezultati kliničnih preskušanj, ki podajajo informacije o diagnostični uporabi zdravila Neuraceq;
In particular, the nuclear medicine doctor in charge of the procedure may provide ways to increase the passing of urine and stools in order to help remove radioactivity from your body.
odgovoren za postopek, lahko še zlasti poskrbi za povečano odvajanje urina in blata, da pospešite izločanje radioaktivnih snovi iz telesa.
Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.
Radiofarmaki se shranjujejo v skladu z nacionalnimi predpisi o radioaktivnih materialih.
February 2014 Date of latest renewal: 20.
Datum pridobitve: 20. februarja 2014 Datum podaljšanja dovoljenja za promet z zdravilom: 20. november 2018
The highest level of uptake is in pons and other white matter regions.
Največji privzem je v ponsu in drugih regijah bele možganovine.
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).
Vsako od teh regij v možganih, lateralna temporalna, frontalna, posteriorna cingularna, precuneus in parietalni režnji, je treba sistematično vizualno ovrednotiti in oceniti v skladu z oceno regionalnega kortikalnega privzema označevalca (RCTU) (Tabela 1).
Cis Bio International Hôpital Xavier Arnozan Avenue du Haut Lévèque 33600 Pessac (Bordeaux) France
Cis Bio International Hôpital Xavier Arnozan Avenue du Haut Lévèque 33600 Pessac (Bordeaux) Francija
Hepatic function abnormal
Nenormalna jetrna funkcija
Appropriate aseptic precautions should be taken.
Treba je sprejeti ustrezne ukrepe za zagotavljanje aseptičnih pogojev.
Method of administration Neuraceq is for intravenous use and for multidose use.
Zdravilo Neuraceq je predvideno za intravensko uporabo in za večodmerno uporabo.
The requirement for submission of periodic safety update report for this medicinal product are set out in the line of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2011/83/EC and any subsequent updates published on the European medicines web-portal.
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
For any information about this medicine, please contact the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na imetnika dovoljenja za promet z zdravilom:
Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients (see section 4.4).
Ledvična in jetrna okvara Količino uporabljene aktivnosti je treba skrbno pretehtati, saj je lahko pri teh bolnikih izpostavljenost sevanju večja (glejte poglavje 4.4).
A brain scan is usually taken 90 minutes after Neuraceq is given.
Preiskava možganov se ponavadi začne 90 minut po injiciranju zdravila Neuraceq.
The volume of Neuraceq to be injected can be from 0.5 to 10 mL in order to provide the target activity of 300 MBq at the time of intravenous administration.
Prostornina zdravila Neuraceq, ki se injicira, lahko znaša od 0,5 do 10 ml, da se zagotovi ciljna aktivnost 300 MBq ob času intravenskega dajanja.
The biophysical basis of the white matter retention of florbetaben (18F) in the living human brain cannot be definitively explained.
Biofizikalne osnove zadrževanja [18F]florbetabena v beli možganovini živih ljudi ni mogoče dokončno pojasniti.
This is equivalent to 1.6% of the recommended maximum daily dietary intake of sodium for an adult.
1,6% priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
At 12 hours post-injection, up to approximately 30% of the injected radioactivity is excreted with urine.
V 12 urah po injiciranju se z urinom izloči do 30 % injiciranih radioaktivnih snovi.
Other medicines and Neuraceq
Druga zdravila in zdravilo Neuraceq
Pol. Ind. Conpisa, C/ Veguillas, 2 Nave 16, Ajalvir 28864 (Madrid) Spain
Pol. Ind. Conpisa, C/ Veguillas, 2 Nave 16, Ajalvir 28864 (Madrid) Španija
Paediatric population There is no relevant use of Neuraceq in the paediatric population.
Zdravilo Neuraceq ni primerno za uporabo pri pediatrični populaciji.
Florbetaben (18F) is eliminated from plasma of AD patients with a mean biological half-life of about 1 hour.
Izločanje [18F]florbetaben se iz plazme bolnikov z AB izloča z biološko razpolovno dobo, ki v povprečju znaša približno 1 uro.
A 20-minute PET image should be acquired starting at approximately 90 minutes after intravenous injection of florbetaben (18F).
Pridobivanje slike 20-minutno slikanje s PET začnite približno 90 minut po intravenskem injiciranju [18F]florbetabena.
- This medicine contains up to 33 mg sodium (main component of cooking/table salt) in each dose.
- To zdravilo vsebuje 33 mg natrija (glavne sestavine kuhinjske soli) na odmerka.
This medicinal product contains up to 1.2 g of ethanol and up to 33 mg of sodium per dose (see section 4.4).
To zdravilo vsebuje do 1,2 g etanola in do 33 mg natrija na odmerek (glejte poglavje 4.4).
Table 2: Definitions of brain amyloid plaque load (BAPL) Assessment
Tabela 2: Definicije odlaganja amiloidnih leh v možganih (BAPL) Ovrednotenje
The injection of florbetaben (18F) must be intravenous in order to avoid irradiation as a result of local extravasation, as well as imaging artefacts.
Injiciranje [18F]florbetabena mora biti intravensko, da ne pride do obsevanja, ki je posledica lokalne ekstravazacije, ali do artefaktov pri slikanju.
Fluorine (18F) has a physical half-life of 110 minutes.
Fizikalna razpolovna doba za fluor (18F) je 110 minut.
The following information is intended for the specialist only: - Keep out of the sight and reach of children.
Naslednje informacije so namenjene samo specialistu: - Zdravilo shranjujte nedosegljivo otrokom!
The recommended activity for an adult is 300 MBq florbetaben (18F).
Priporočena aktivnost za odraslega je 300 MBq [18F]florbetabena.
The European Medicines Agency has waived the obligation to submit the results of studies with florbetaben (18F) in all subsets of the paediatric population as the disease or condition for which the specific medicinal product is intended only occurs in adult population, and the specific medicinal product does not represent a significant therapeutic benefit over existing treatments for paediatric patients (see section 4.2 for information on paediatric use).
[18F]florbetabenom za vse podskupine pediatrične populacije, saj se bolezen oziroma zdravstveno stanje, kateremu je to zdravilo namenjeno, pojavlja samo pri odrasli populaciji, zdravilo pa ne izkazuje pomembnih terapevtskih prednosti v primerjavi z obstoječimi zdravljenji za pediatrične bolnike (glejte poglavje 4.2 za podatke o uporabi pri pediatrični populaciji).
If you have been given more Neuraceq than you should
Če ste uporabili večji odmerek zdravila Neuraceq, kot bi smeli
The vials must not be opened before disinfecting the stopper, the solution should be withdrawn via the stopper using a single dose syringe fitted with suitable protective shielding and a disposable sterile needle or using an authorised automated application system.
raztopino pa morate odvzeti prek zamaška z enoodmerno injekcijsko brizgo, opremljeno z ustrezno zaščito in sterilno iglo za enkratno uporabo, ali z uporabo odobrenega avtomatskega sistema apliciranja.
LEAD POT (without Blue Box)
SVINČENI VSEBNIK (brez modrega okenca)
At the 24-month follow-up, 19 (42.2%) converted to clinical AD. Of the 29 MCI subjects who had a positive PET scan, 19 (65.5%) were classified clinically as converted to clinical AD after 24 months compared to 0 (0%) of 16 who had a negative scan.
24 mesecev pozneje jih je 19 (42,2 %) prešlo v klinično AB. Od 29 preiskovancev z blago kognitivno okvaro, ki so imeli pozitiven rezultat PET-preiskave, jih je 24 mesecev pozneje 19 (65,5 %) prešlo v klinično AB, v primerjavi z 0 (0 %) od 16, ki so imeli negativen rezultat preiskave.
A positive scan does not independently establish a diagnosis of AD or other cognitive disorder since neuritic plaque deposition in grey matter may be present in asymptomatic elderly and some neurodegenerative dementias (AD, Lewy body dementia, Parkinson's disease dementia).
Omejitve uporabe Pozitiven rezultat preiskave sam po sebi ne postavlja diagnoze AB ali druge kognitivne okvare, saj je lahko odlaganje nevritičnih leh v sivi možganovini prisotno pri asimptomatskih starejših osebah in pri nekaterih nevrodegenerativnih demencah (AB, demenca z Lewyjevimi telesci, demenca pri Parkinsonovi bolezni).
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.
Zdravilo Neuraceq je radiofarmak, indiciran za slikanje gostote β-amiloidnih nevritičnih leh s pozitronsko emisijsko tomografijo (PET) v možganih odraslih bolnikov s kognitivno motnjo, pri katerih se ugotavljajo Alzheimerjeva bolezen (AB) in drugi vzroki kognitivne motnje.
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.
Zdravilo Neuraceq se daje z injekcijo v veno (intravenska injekcija), ki ji sledi spiranje z raztopino natrijevega klorida, s čimer se zagotovi injiciranje celotnega odmerka.
Neuraceq is a clear, colourless solution for injection.
Zdravilo Neuraceq je bistra, brezbarvna raztopina za injiciranje.
If the integrity of the vial is compromised, the medicinal product should not be used.
Če je integriteta viale ogrožena, zdravila ne smete uporabiti.
Gastrointestinal disorders
Gastrointestinalni trakt
Any unused material should be disposed of in accordance with national regulations.
Neporabljen material zavrzite v skladu z nacionalnimi predpisi.
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.
V primerih negotovosti glede lokacije sive možganovine ter roba med sivo in belo možganovino na PET-posnetku in ko je na voljo nedavna sočasna CT- ali MR-slika, naj razlagalec pregleda združeni PET-CT- oziroma PET-MR-sliki, da razjasni razmerje med radioaktivnostjo pri PET in anatomijo sive možganovine.
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.
Pri longitudinalni študiji je 45 preiskovancev, ki so imeli klinično diagnozo blage kognitivne okvare, opravilo izhodiščno PET-preiskavo s [18F]florbetabenom, nato pa so jih 24 mesecev spremljali ter vrednotili zvezo med slikanjem s [18F]florbetabenom in spremembami statusa diagnoze.
1 (No tracer uptake)
1 (brez privzema označevalca)
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.
Fluor (18F) z oddajanjem pozitronskega sevanja s 634 keV, čemur sledi fotonsko anihilacijsko sevanje s 511 keV, razpade na stabilni kisik (18O) z razpolovno dobo približno 110 minut.
Uptake of radioactivity in the brain is rapid, reaching about 6% of injected radioactivity at 10 minutes post injection.
Privzem radioaktivnih snovi v možganih poteka hitro, saj 10 minut po injiciranju doseže približno 6 % injiciranih radioaktivnih snovi.
Studies on reproduction toxicity have not been performed.
Študij o vplivu na sposobnost razmnoževanja niso izvedli.
What Neuraceq is and what it is used for What you need to know before Neuraceq is used How Neuraceq will be used Possible side effects
Kaj je zdravilo Neuraceq in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Neuraceq Kako uporabljati zdravilo Neuraceq
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.
Slike se pregledujejo sistematično (Slika 1), začenši na ravni malih možganov, nato skozi lateralni temporalni in frontalni reženj do območja posteriorne cingularne skorje in precuneusa, ter končno do parietalnega režnja.
What Neuraceq is and what it is used for
Kaj je zdravilo Neuraceq in za kaj ga uporabljamo
Some scans may be difficult to interpret due to image noise, atrophy with a thinned cortical ribbon, or image blurs, which could lead to interpretation errors.
Nekatere posnetke je zaradi šuma na sliki, atrofije s stanjšanim kortikalnim trakom ali zamegljenosti slike težko interpretirati, zato lahko pri interpretaciji pride do napak.
RCTU score 1 in each of the 4 brain regions (lateral temporal lobes, frontal lobes, posterior cingulate/precuneus, parietal lobes)
RCTU-ocena 1 v vseh štirih regijah v možganih (lateralni temporalni reženj, frontalni reženj, posteriorna cingularna skorja/precuneus, parietalni reženj)
Alliance Medical Radiopharmacy Ltd. Unit 19, Quadrum Park, Old Portsmouth Road Peasmarsh, Guildford, Surrey, GU3 1LU United Kingdom
Alliance Medical Radiopharmacy Ltd. Unit 19, Quadrum Park, Old Portsmouth Road Peasmarsh, Guildford, Surrey, GU3 1LU Velika Britanija
29 (64.4%) of MCI patients were positive by florbetaben (18F) PET scan.
29 (64,4 %) bolnikov z blago kognitivno okvaro je imelo pozitiven rezultat PET-preiskave s [18F]florbetabenom.
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).
Občutljivost preiskave s [18F]florbetabenom za dokaz stopnje prehoda zmerne iz kognitivne okvare v AB pri 19 preiskovancih, pri katerih je prišlo do prehoda, je bila 100 %, specifičnost pri 26 preiskovancih, pri katerih ni prišlo do prehoda, je bila 61,5 % (95-odstotni IZ: 42,8-80,2 %), pozitivno razmerje verjetij pa je bilo 2,60 (1,60-4,23).
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority.
Imetnik dovoljenja za promet z zdravilom se mora pred začetkom dajanja zdravila v promet dogovoriti s pristojnim nacionalnim organom v vsaki državi članici o vsebini končnega izobraževalnega programa.
1081 HV Amsterdam The Netherlands
De Boelelaan 1081 1081 HV Amsterdam Nizozemska
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.
Ker je pri aplikaciji maksimalne priporočene aktivnosti 300 MBq [18F]florbetabena učinkoviti odmerek približno 5,8 mSv, je možnost za pojav teh neželenih učinkov majhna.
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.
Velik povezan predel privzema označevalca, ki je enak kot ali večji od tistega, ki je prisoten v beli možganovini; razširja se čez rob bele možganovine do zunanje kortikalne meje in zajema celotno regijo, vključno z večino režnjev znotraj zadevne regije.
Neuraceq contains ethanol and sodium ascorbate
Zdravilo Neuraceq vsebuje etanol in natrijev askorbat
Colourless 15 mL Type I glass vial, sealed with a chlorobutyl stopper and aluminium seal.
15 ml brezbarvna steklena viala (steklo tipa I), zaprta s klorobutilnim zamaškom in aluminijasto zaporko.
Rule for assessment
Pravilo za ovrednotenje
A positive scan indicates moderate to frequent density.
Pozitiven rezultat preiskave kaže na zmerno do visoko gostoto.
After intravenous bolus injection a radioactivity concentration of 2-3% injected dose/L is achieved in arterial plasma 10 minutes after injection.
10 minut po injiciranju z bolusno intravensko injekcijo doseže koncentracija radioaktivnih snovi vrednost 2-3 % injiciranega odmerka/l v arterijski plazmi.
What you need to know before Neuraceq is used Neuraceq must not be used:
Kaj morate vedeti, preden boste uporabili zdravilo Neuraceq Ne uporabljajte zdravila Neuraceq:
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).
Če prostornina injiciranja znaša od 0,5 do 1 ml, naj se uporabijo le injekcijske brizge ustrezne velikosti (1 ml), injekcijsko brizgo pa je treba sprati z raztopino natrijevega klorida (glejte poglavje 12).
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.
Če prostornina injiciranja znaša od 0,5 do 1 ml, naj se uporabijo le injekcijske brizge ustrezne velikosti (1 ml), injekcijsko brizgo pa je treba sprati z raztopino natrijevega klorida.
Florbetaben (18F) should not be diluted.
[18F]florbetaben se ne sme razredčiti.
A negative scan indicates sparse or no density of cortical β-amyloid plaques.
Negativen rezultat preiskave kaže na nizko ali ničelno gostoto kortikalnih β-amiloidnih leh.
Pregnant
Nosečnost
Healthy controls show relatively low levels of florbetaben (18F) retention in cortex.
Pri zdravih kontrolah se pokaže, da je zadrževanje [18F]florbetabena v skorji razmeroma majhno.
Injection site pain Injection/application site erythema
Eritem na mestu injiciranja/aplikacije
Administration of Neuraceq and conduct of the procedure
Dajanje zdravila Neuraceq in izvedba postopka
Curium Pharma Spain, S.A. Pol. Ind. Conpisa, C/ Veguillas - 2 Nave 16, Ajalvir 28864 (Madrid) Spain
Curium Pharma Spain, S.A. Pol. Ind. Conpisa, C/ Veguillas - 2 Nave 16, Ajalvir 28864 (Madrid) Španija
- 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”).
- Druge sestavine zdravila so askorbinska kislina, brezvodni etanol, makrogol 400, natrijev askorbat in voda za injekcije (glejte poglavje 2 "Zdravilo Neuraceq vsebuje etanol in natrijev askorbat").
Red marrow Osteogenic cells Skin
Osteogene celice Koža
Interpretation of Neuraceq images
Interpretacija slik z zdravilom Neuraceq
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.
Ključna študija, ki je vključevala 31 bolnikov ob koncu življenja, je bila namenjena ocenjevanju diagnostične učinkovitosti [18F]florbetabena za zaznavanje gostote kortikalnih nevritičnih leh (ničelna ali nizka v primerjavi z zmerno ali visoko), določene po merilu CERAD.
Life Radiopharma Berlin GmbH, Max-Planck-Straße 4, 12489 Berlin, DE
Life Radiopharma Berlin GmbH, Max-Planck-Straße 4, 12489 Berlin, Germany
You must stop breast-feeding for 24 hours after the injection.
Dojenje morate po injiciranju prekiniti za 24 ur.
It is supplied in a colourless 15 mL glass vial, sealed with a rubber stopper and aluminium seal.
Na voljo je v brezbarvnih steklenih vialah po 15 ml, zaprtih z gumijastim zamaškom in aluminijasto zaporko.
Cis Bio International CHU de Brabois Avenue de Bourgogne 54500 Vandoeuvre les Nancy France
Cis Bio International CHU de Brabois Avenue de Bourgogne 54500 Vandoeuvre les Nancy Francija
Neuraceq is given to people with memory problems so that doctors can perform a type of brain scan, called a PET scan.
Zdravilo Neuraceq se daje bolnikom, ki imajo težave s spominom, da zdravniki lahko opravijo možgansko preiskavo, imenovano PET-preiskava.
For an administered activity of 360 MBq the typical radiation dose to the target organ (brain) is 4.5 mGy.
Pri uporabljeni aktivnosti 360 MBq tipični odmerek sevanja, ki ga prejme ciljni organ
Pack size: one vial
Velikost pakiranja: ena viala.
Harmful for those suffering from alcoholism, and is also to be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Na vsebnost etanola (alkohola) morajo biti pozorne nosečnice in doječe matere, otroci in skupine z velikim tveganjem, kot so bolniki z jetrnimi obolenji ali epilepsijo.
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.
Ob primerjavi rezultatov odčitavanja PET-preiskave in histopatološke ocene, pridobljene za vse subjekte (enako kot pri uporabi za prvotno ključno študijo in njeno post hoc analizo), je bila večina vrednosti za odčitano občutljivost oziroma specifičnost 100 % (95-odstotni IZ: 89,4-100 %)
Figure 1: Neuraceq PET cases showing examples of negative florbetaben (18F) PET scan (top row) and positive scan (bottom row).
Slika 1: Slikanje s PET z zdravilom Neuraceq, ki prikazuje primere negativnih rezultatov PETpreiskave s [18F]florbetabenom (zgornja vrsta) in pozitivnih rezultatov preiskave (spodnja vrsta).
Increased uptake has been identified in extracerebral structures such as face, scalp and bone in some cases.
V nekaterih primerih so opazili povečan privzem v zunajmožganskih strukturah, na primer v obrazu, lasišču in kosteh.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri enkratnem in ponavljajočih se odmerkih ter genotoksičnosti ne kažejo posebnega tveganja za človeka.
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.
Preden boste dobili zdravilo Neuraceq, se posvetujte z zdravnikom nuklearne medicine, če obstaja možnost, da ste noseči, če zamujate z menstruacijo ali če dojite.
In vitro, florbetaben (18F) shows nanomolar binding affinity to synthetic β-amyloid fibrils and to AD brain homogenate.
In vitro [18F]florbetaben izkazuje afiniteto do nanomolarne vezave na sintetična β-amiloidna vlakna in homogenat možganov z AB.
No radioactivity could be measured in blood at about 4 hours post injection.
Približno 4 ure po injiciranju ni več mogoče najti radioaktivnih snovi v krvi.
No fertility studies have been performed.
Plodnost Študije plodnosti niso bile opravljene.
- 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.
- To zdravilo vsebuje 15 vol % etanola (alkohola), to je do 1,2 g na odmerek, kar ustreza 30 ml piva oziroma 12,5 ml vina na odmerek.
The pharmacokinetics of florbetaben (18F) in patients with renal or hepatic impairment has not been characterised.
Farmakokinetika [18F]florbetabena pri bolnikih z ledvično ali jetrno okvaro ni bila določena.