natgillin/translations-raw huggingface dataset:
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.
Če se kot del postopka PET istočasno opravi tudi slikanje s CT, se bo izpostavljenost ionizirajočemu sevanju povečala za količino, ki je odvisna od nastavitev za zajemanje s CT.
Radiopharmaceuticals should be prepared in a manner that satisfies both radiation safety and pharmaceutical quality requirements.
Radiofarmake je treba pripraviti na način, ki bo zadoščal zaščiti pred sevanjem in tudi farmacevtskim zahtevam po kakovosti.
This medicinal product contains (7 vol %) of ethanol (alcohol), i.e. up to 552 mg (approximately 0.7 mL) per dose.
To zdravilo vsebuje (7 vol %) etanola (alkohola), to je do 552 mg (približno 0,7 ml) na odmerek.
This medicine is a radiopharmaceutical product for diagnostic use only.
To zdravilo je radiofarmacevtski izdelek in se uporablja le za diagnosticiranje.
Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority.
Pred prihodom zdravila na trg v vsaki državi članici se mora imetnik dovoljenja za promet s pristojnim nacionalnim organom dogovoriti glede končnega izobraževalnega programa.
The use of VIZAMYL involves exposure to small amounts of radioactivity.
Uporaba zdravila VIZAMYL vključuje izpostavljenost majhnim količinam radioaktivnosti.
• Review of the PET reading criteria, including method of image review, criteria for interpretation, and images demonstrating the binary read methodology.
• Pregled kriterijev odčitavanja PET posnetkov, vključno z metodo pregledovanja, kriterije za interpretacijo in posnetke, ki pojasnjujejo binarno metodologijo odčitavanja.
This product will only be handled and given to you by professionals who are trained and qualified to use it safely.
Z zdravilom bodo ravnali in vam ga dajali le strokovnjaki, usposobljeni in kvalificirani za njegovo varno uporabo.
EXPIRY DATE EXP: reference time +8 h
DATUM IZTEKA ROKA UPORABNOSTI EXP: referenčni čas +8 h
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.
Če obstaja negotovost glede možne nosečnosti (če ženska ni dobila menstruacije, če je menstruacija zelo neredna, itd.), je treba bolnici ponuditi nadomestno tehniko (če je na voljo), ki ne vključuje uporabe ionizirajočega sevanja.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
VIZAMYL will only be used in special controlled areas.
Zdravilo VIZAMYL se uporablja samo v posebno nadzorovanih prostorih.
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.
Pred dajanjem radiofarmaka doječi materi je treba razmisliti o možnosti preložitve dajanja radionuklida, dokler mati ne neha dojiti, in o izbiri najustreznejšega radiofarmaka, ob upoštevanju izločanja aktivnosti v materino mleko.
The patient should be encouraged to void prior to and following imaging with VIZAMYL, and frequently thereafter for the next 24 hours.
Bolnika spodbujajte k odvajanju urina pred in po slikanju z zdravilom VIZAMYL, in pogosto v naslednjih 24 urah.
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.
Celoten SmPC zdravila VIZAMYL je priložen kot ločen dokument v pakiranju zdravila z namenom, da zagotovi zdravstvenim strokovnjakom druge znanstvene ali praktične informacije o odmerjanju radiofarmaka.
Pharmacotherapeutic group: diagnostic radiopharmaceutical, central nervous system, ATC code: V09AX04
Farmakoterapevtska skupina: radiodiagnostiki za ugotavljanje bolezni osrednjega živčevja, oznaka ATC: V09AX04
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.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom nuklearne medicine, preden vzamete to zdravilo.
Values were calculated assuming emptying of the urinary bladder at 3.5-hour intervals and human biodistribution data using OLINDA/EXM software.
Vrednosti so izračunane ob predvidevanju praznjenja mehurja v intervalih po 3,5 ure in iz podatkov biološke porazdelitve pri ljudeh z uporabo programske opreme OLINDA/EXM.
98 (42%) of the 232 patients had abnormal (positive) flutemetamol (18F) scans.
Pri 98 (42 %) od 232 bolnikov so bili posnetki s flutemetamolom (18F) nenormalni (pozitivni).
White matter - p pons and cc corpus callosum.
Bela možganovina - p pons in cc kalozni korpus.
The dose is administered by intravenous bolus injection within approximately 40 seconds.
Odmerek se daje z intravensko injekcijo v bolusu v trajanju približno 40 sekund.
VIZAMYL is used to help diagnose Alzheimer's disease and other causes of memory loss.
Zdravilo VIZAMYL se uporablja za diagnosticiranje Alzheimerjeve bolezni in drugih vzrokov izgube spomina.
Express the breast milk during this period and discard any breast milk you have expressed.
V tem obdobju izčrpajte mleko in vsega zavrzite.
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.
Pet organov/tkiv z najvišjo kumulativno aktivnostjo so stene tankega črevesa, jetra, sečni mehur, stene zgornjega debelega črevesa in stene žolčnika.
The PET results were compared with the neuritic plaque density measured on sections of eight predefined brain regions at the patient's autopsy.
Rezultati PET so bili primerjani z gostoto nevritičnih leh, izmerjeno v odsekih osmih vnaprej definiranih območjih možganov pri obdukciji bolnikov.
The nuclear medicine doctor will only give this medicine during pregnancy if a benefit is expected which would outweigh the risks.
Zdravnik nuklearne medicine bo zdravilo med nosečnostjo predpisal le, če pričakovana korist odtehta tveganja.
Table 2 below shows the dosimetry as calculated using the OLINDA/EXM (Organ Level INternal Dose Assessment/Exponential Modeling) software.
V spodnji preglednici 2 je prikazano odmerjanje izračunano s programsko opremo OLINDA/EXM (Organ Level INternal Dose Assessment/Exponential Modelling).
INFORMATION IN BRAILLE Justification for not including Braille accepted 17.
PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna 17.
This may need to be taken into consideration by patients on a controlled sodium diet.
To morajo upoštevati bolniki, ki so na dieti z nadzorovanim vnosom natrija.
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.
Atrofija je lahko prisotna v mnogih delih možganov in oteži interpretacijo posnetka, saj ima izguba sive možganovine za posledico zmanjšano mero privzemanja označevalca, zaradi česar je prepoznavanje pozitivnega posnetka težje.
PET images should be read using a Sokoloff, Rainbow or Spectrum colour scale.
Posnetke PET je treba odčitati z uporabo lestvic Sokoloff, mavrične ali barvne.
Method of preparation The package must be checked before use and the activity measured using a dose calibrator.
Način priprave Pred uporabo je treba pregledati ovojnino in s kalibratorjem odmerka izmeriti aktivnost.
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.
Zaradi tega po prejemu zdravila VIZAMYL bolnikom priporočamo, da ne vozijo, upravljajo zapletenih strojev ali opravljajo kakšne druge morebiti nevarne dejavnosti, dokler ti učinki ne izzvenijo v celoti.
VIZAMYL images should be acquired starting 90 minutes after injection, using a PET scanner in 3D mode with appropriate data corrections.
Posnetke z uporabo zdravila VIZAMYL je treba pridobiti 90 minut po injiciranju zdravila, z uporabo skenerja PET v načinu 3D z ustreznimi popravki podatkov.
A brain scan is usually taken 90 minutes after VIZAMYL is given.
Slikanje možganov se običajno opravi 90 minut po odmerjanju zdravila VIZAMYL.
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.
Injiciranje zdravila VIZAMYL prek kratkega intravenskega katetra (dolžina približno 12,5 cm ali manj) zmanjša možnost za adsorpcijo zdravilne učinkovine na kateter na najmanjšo možno mero.
If at any time in the preparation of this product the integrity of the vial is compromised, it should not be used.
Če je kadarkoli med pripravo zdravila integriteta viale ogrožena, je ne smete uporabiti.
In AD patients, cortical regions and striatal regions show significantly greater uptake compared to cortical regions in controls.
Pri bolnikih z AB je privzemanje v kortikalnih območjih in v območij brazd bistveno večje v primerjavi s kortikalnimi območji pri kontrolnih osebah.
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.
Možnost preobčutljivostne ali anafilaktične reakcije Če se pojavita preobčutljivostna ali anafilaktična reakcija, morate uporabo zdravila nemudoma prekiniti in po potrebi sprožiti intravensko zdravljenje.
The scan duration should typically be 20 minutes.
Slikanja običajno traja 20 minut.
Radioactive medicine
Radioaktivno zdravilo
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) razpade na stabilen kisik (18O) z razpolovno dobo približno 110 minut, pri tem pride do pozitronske emisije s sevanjem 634 keV, čemur sledi 511 keV sevanje zaradi anihilacije fotonov.
The negative images show a tapered intensity to the periphery of the tissue.
Negativni posnetki kažejo pojemajočo intenziteto v periferiji tkiva.
The efficacy of flutemetamol (18F) for predicting development of AD or monitoring response to therapy has not been established (see section 5.1).
Učinkovitost flutemetamola (18F) pri napovedovanju razvoja AB ali spremljanju odziva na zdravljenje še ni bila ugotovljena (glejte poglavje 5.1).
Reducing head movement with tape or other flexible head restraints may be employed.
Za zmanjšanje premikanja glave lahko uporabite trak ali drug fleksibilen pripomoček za omejevanje premikanja glave.
The apparent elimination half-life is 4.5 hours whereas the radioactive half-life of flutemetamol (18F) is 110 minutes.
Navidezni razpolovni čas izločanja je 4,5 ur, medtem ko je radioaktivni razpolovni čas flutemetamola (18F) 110 minut.
Each mL of solution contains 55.2 mg of ethanol and 4.1 mg of sodium.
En ml raztopine vsebuje 55,2 mg etanola in 4,1 mg natrija.
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.
Upoštevajte, da je intenziteta večja (> 60 % največje) v predelih sive možganovine na pozitivnih posnetkih v primerjavi z negativnimi posnetki, ter da se intenziteta širi z ostro določenim konveksnim robom v lateralnih legah.
It is hypothesized that solubility of the radiopharmaceutical in the lipid content of brain tissues may contribute to white matter retention.
Domneva se, da topnost radiofarmaka v lipidni vsebini možganskih tkiv lahko prispeva k zadrževanju v beli možganovini.
VIZAMYL should be used in conjunction with a clinical evaluation.
Zdravilo VIZAMYL je treba uporabiti skupaj s kliničnim vrednotenjem.
Interpretation of the images is performed visually by comparing the activity in cortical grey matter with activity in adjacent cortical white matter.
Interpretacija posnetkov se naredi vizualno s primerjavo aktivnosti v sivi možganovini in aktivnosti v sosednji beli možganovini.
The activity of flutemetamol (18F) has to be measured with a dose calibrator immediately prior to injection.
Aktivnost flutemetamola (18F) je treba meriti s kalibratorjem odmerka tik pred injiciranjem.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
V vsaki skupini pogostosti so neželeni učinki prikazani v zaporedju padajoče resnosti.
The sulcal and gyral pattern is not discernible in the positive images on the right.
Vzorec sulkusov in girusov ni viden na pozitivnih posnetkih.
Do not use this medicine if you notice that the vial is damaged or the solution contains particulate matter or appears discoloured.
Zdravila ne uporabljajte, če opazite, da je viala poškodovana ali da so v raztopini delci ali je obarvana.
For precautions with respect to environmental hazard see section 6.6.
Za varnostne ukrepe glede nevarnosti za okolje glejte poglavje 6.6.
It is given to adults with memory problems before they undergo a type of brain scan called a positron-emission tomography (PET) scan.
Da se ga odraslim osebam, ki imajo težave s spominom, preden gredo na slikanje možganov, imenovano pozitronska emisijska tomografija (PET).
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.
Obvestite zdravnika nuklearne medicine, če jemljete ali ste pred kratkim jemali katera koli druga zdravila, saj lahko vplivajo na interpretacijo slik, ki jih dobimo po slikanju možganov.
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).
Ne uporabljajte zdravila VIZAMYL: Če ste alergični na flutemetamol (18F) ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
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.
Flutemetamol (18F) je bil pozitiven v in vitro testiranju genotoksičnosti na bakterijah in celicah sesalcev, a negativen v treh različnih in vivo študijah z dovolj visokimi odmerki.
You should discuss the results of the test with the doctor that requested the scan.
O rezultatih testa se pogovorite z zdravnikom, ki je slikanje predpisal.
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.
Imetnik dovoljenja za promet mora zagotoviti, da bodo po razpravi in dogovoru s pristojnim nacionalnim organom v državi, v kateri se zdravilo VIZAMYL trži, ob prihodu zdravila na trg in po njem vsi zdravniki, za katere se pričakuje, da bodo uporabljali zdravilo VIZAMYL imeli dostop do usposabljanja, za zagotovitev natančne in zanesljive interpretacije posnetkov PET.
Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus.
Pri postopkih z radionuklidi, ki se opravijo na nosečnicah, prejme odmerek sevanja tudi njihov plod.
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.
Pri uporabi intravenskega kanala je po injiciranju treba opraviti intravenozno spiranje s 5 ml do 15 ml sterilne raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje, s čimer se zagotovi injiciranje celotnega odmerka.
Please refer to the SmPC {SmPC should be included in the box}.
Glejte SmPC {SmPC mora biti priložen v pakiranju}.
Due to the small quantity of flutemetamol (18F) in each dose, overdose is not expected to result in pharmacological effects.
Zaradi majhne količine flutemetamola (18F) v vsakem odmerku, ni pričakovati, da bi prekomeren odmerek imel farmakološke učinke.
185 MBq the typical radiation dose to the target organ (brain) is 2.0 mGy.
Za odmerjeno aktivnost 185 MBq je značilen odmerek sevanja za ciljni organ (možgani) 2,0 mGy.
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.
Učinkoviti odmerek pri odraslem po dajanju odmerka največje priporočene aktivnosti 185 MBq za odraslo osebo, ki tehta 70 kg, je približno 5,9 mSv.
The estimated absorbed radiation doses for adults following intravenous injection of VIZAMYL are shown in Table 2.
Ocenjen absorbiran odmerek sevanja pri odraslih po intravenskem injiciranju zdravila VIZAMYL je prikazan v preglednici 2.
What VIZAMYL is and what it is used for
Kaj je zdravilo VIZAMYL in za kaj ga uporabljamo
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.
Občutljivost in specifičnost za oceno nalaganja flutemetamola (18F) v β-amiloidnih lehah sta bili nadalje preučeni v eni dodatni študiji, v kateri je druga skupina slepo izbranih 5 odčitovalcev, ki so imeli usposabljanje v elektronski obliki, interpretiralo posnetke istih 68 bolnikov, pri katerih je bila v ključni študiji opravljena obdukcija.
Brain uptake and distribution of flutemetamol (18F) were not evaluated in a specific study aimed to evaluate pharmacodynamics.
Možgansko privzemanje in porazdelitev flutemetamola (18F) nista bila ovrednoteni v posebnih študijah z namenom ocenjevanja farmakodinamike.
It is strongly recommended to review MR or CT images when available to aid interpretation of the VIZAMYL image, especially when atrophy is suspected.
Zelo priporočljivo je, da kot pomoč pri interpretaciji posnetka z uporabo zdravila VIZAMYL pregledate slike MR ali CT, če jih imate na voljo, še zlasti ko obstaja sum na atrofijo.
A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. For the limitations in the interpretation of a positive scan, see sections 4.4 and 5.1.
Negativen rezultat preiskave kaže na redke ali odsotne lehe, kar se ne ujema z diagnozo AB. Za omejitve pri interpretaciji pozitivnega rezultata preiskave glejte poglavji 4.4 in 5.1. 4.2 Odmerjanje in način uporabe
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).
S tem radiofarmakom prejmete majhne količine ionizirajočega sevanja, ki je povezano z zelo majhnim tveganjem za razvoj raka in dednih nepravilnosti (tj. genetskih bolezni).
Elimination and half-Life Flutemetamol (18F) is rapidly cleared from circulation (through the intestinal and urinary tracts).
Izločanje in razpolovni čas Flutemetamol (18F) se hitro odstrani iz krvnega obtoka (skozi prebavni in sečni trakt).
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.
To zdravilo vsebuje do 41 mg (1,8 mmol) natrija na odmerek, kar je enako 2 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g..
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.
Vial ne smete odpreti, dokler ne razkužite zamaška, 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.
There is no relevant use of VIZAMYL in the paediatric population.
Zdravilo VIZAMYL ni namenjeno za uporabo pri pediatrični populaciji.
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).
Pozitiven rezultat ocene posnetka sam po sebi ne postavlja diagnoze AB ali druge kognitivne okvare, saj je nastajanje nevritičnih leh v sivi možganovini lahko prisotno pri asimptomatskih starejših osebah in osebah z nekaterimi nevrodegenerativnimi demencami (Alzheimerjeva bolezen, demenca z Lewyjevimi telesci, demenca pri Parkinsonovi bolezni).
Read the package leaflet before use.
Pred uporabo natančno preberite priloženo navodilo!
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.
Gesla: siva možganovina - f frontalni in ac anteriorni cingulatni, pc posterioni cingulati in prekuneusni, lt stranski temporalni , tp temporo-parietalni in in insula in s striatum.
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.
Signal ne bo popolnoma odsoten v območjih sive možganovine na posnetkih, saj se bo bela možganovina, ki je vezana s sosednjimi območji, zlila z območji sive možganovine, zaradi delnih prostorninskih učinkov ločljivosti PET.
The injection of flutemetamol (18F) must be intravenous in order to avoid irradiation as a result of local extravasation, as well as imaging artefacts.
Injiciranje flutemetamola (18F) mora biti intravensko, da se prepreči obsevanje zaradi lokalnega izliva in artefakte pri slikanju.
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.
Zdravilo VIZAMYL lahko uporabljajo zdravniki, ki so posebej usposobljeni in izkušeni pri varni uporabi in ravnanju z radionuklidi ter katerih izkušnje in usposabljanje je potrdil pristojni upravni organ za podeljevanje licenc za uporabo radiofarmakov, ali osebe pod nadzorom takih zdravnikov.
Activity: 400 MBq/mL at {hh:mm} {Time Zone} on {dd-mm-yyyy} Activity: YYYY MBq at hh:mm {Time Zone} dd-mm-yyyy
Aktivnost: 400 MBq/ml ob {hh:mm} {časovni pas} dne {dd-mm-llll} Aktivnost: LLLL MBq v hh:mm {časovni pas} dd-mm-llll
• 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.
• Gradivo mora vsebovati primere posnetkov PET z zdravilom VIZAMYL in pravilno interpretacijo izkušenega odčitovalca; posnetke PET z zdravilom VIZAMYL za samooceno in postopek samokvalifikacije za vsakega udeleženca usposabljanja.
Axial view (first row), sagittal view (second row) and coronal view (third row) are displayed.
Prikazani so aksialni pogled (prva vrstica), sagitalni pogled (druga vrstica) in koronalni pogled (tretja vrstica).