FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of flutemetamol (18F) in patients with renal or hepatic impairment has not been characterised.
Slovenian: Farmakokinetika flutemetamola (18F) pri bolnikih z ledvično ali jetrno okvaro ni bila določena.
English: This is equivalent to approximately 2% of the adult recommended maximum daily dietary intake for sodium These amounts may need to be considered for people on a low sodium diet.
Slovenian: To je enako 2 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finland ITEL Telecomunicazioni, Via Labriola (ZI, Lotto 40), 70037, Ruvo di Puglia, Italy Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, 01328 Dresden, Germany
Slovenian: MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finska ITEL Telecomunicazioni, Via Labriola (ZI, Lotto 40), 70037, Ruvo di Puglia, Italija Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, 01328 Dresden, Nemčija
English: SPECIAL STORAGE CONDITIONS Storage in accordance with national regulation on radiopharmaceuticals.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjevanje v skladu z nacionalnimi predpisi za radioaktivne materiale.
English: In AD patients, as in controls, there is high retention in pons and other white matter areas.
Slovenian: Pri bolnikih z AB in pri kontrolnih osebah je zadrževanje večje v mostu in drugih območjih bele možganovine.
English: To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease or epilepsy.
Slovenian: Na vsebnost etanola (alkohola) morajo biti pozorne nosečnice ali doječe matere in skupine z velikim tveganjem, kot so bolniki z jetrnimi obolenji ali epilepsijo.
English: VIZAMYL is for intravenous use.
Slovenian: Način uporabe Zdravilo VIZAMYL je namenjeno intravenski uporabi.
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.
Slovenian: Zdravnik nuklearne medicine vas bo morda prosil, da pred začetkom preiskave in 24 ur po njej pijete veliko vode.
English: Elimination of flutemetamol (18F) is approximately 37% renal and 52% hepatobiliary.
Slovenian: Približno 37 % flutemetamola (18F) se izloči renalno, 52 % pa skozi jetra, žolčnik in žolčevode.
English: Position the patient supine with the patient's brain (including the cerebellum) within a single field of view.
Slovenian: Bolnika namestite v ležeč položaj, tako da so njegovi možgani (skupaj z malimi možgani) v enem samem vidnem polju.
English: A positive scan indicates a moderate to frequent density.
Slovenian: Pozitiven rezultat posnetka kaže na zmerno do veliko gostoto.
English: The other ingredients are sodium chloride and ethanol anhydrous, polysorbate 80, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate and water for injections, see section 2.
Slovenian: Druge sestavine zdravila so natrijev klorid in brezvodni etanol, polisorbat 80, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dodekahidrat in voda za injekcije, glejte poglavje 2.
English: How VIZAMYL is stored Contents of the pack and other information
Slovenian: Shranjevanje zdravila VIZAMYL Vsebina pakiranja in dodatne informacije
English: Image interpretation errors in the estimation of brain β-amyloid neuritic plaque density, including false negatives and false positives, have been observed.
Slovenian: Pri interpretaciji posnetkov v oceni možganske gostote βamiloidnih nevritičnih leh so opazili napake, ki so vključevale lažno negativne in lažno pozitivne rezultate.
English: In a re-reading study that increased the patient population of the pivotal study to include 38 additional autopsied patients (i.e., 106 in total), sensitivity and specificity for detection of moderate-frequent βamyloid neuritic plaque density in the primary analysis were 91% (95% CI: 82% to 96%) and 90% (95% CI: 74% to 98%), respectively, based on the majority read (i.e., the image interpretation reached by at least 3 of the 5 readers after electronic training).
Slovenian: V študiji vnovičnega odčitavanja, v kateri je bila populacija bolnikov klinični študiji, ki podpira vlogo za pridobitev dovoljenja za promet povečana, da je bilo vključenih dodatnih 38 bolnikov, pri katerih je bila opravljena obdukcija (tj. skupno 106), sta bili občutljivost in specifičnost za določitev zmernepogoste gostote β-amiloidninih nevritičnih leh v primarni analizi 91 % (95 % IZ: 82 % do 96 %) oziroma 90 % (95 % IZ: 74 % do 98 %) pri večini odčitavanj slik (tj. interpretacija slik je bila dosežena pri vsaj 3 od 5 odčitovalcev po opravljenem usposabljanju v elektronski obliki).
English: The majority read sensitivity and specificity were 93% (95% CI: 81% to 99%) and 84% (95% CI: 64% to 96%), respectively.
Slovenian: Občutljivost in specifičnost sta bili 93 % (95 % IZ: 81% do 99%) oziroma 84 % (95 % IZ: 64 % do 96%) pri večini odčitavanj slik.
English: VIZAMYL PET cases showing examples of negative flutemetamol (18F) PET scan (left) and positive scan (right).
Slovenian: Primeri posnetkov PET ob uporabi zdravila VIZAMYL, kjer sta prikazana negativen flutemetamol (18F) posnetek PET (levo) in pozitivna slika (desno).
English: Other medicines and VIZAMYL
Slovenian: Druga zdravila in zdravilo VIZAMYL
English: SHIELD LABEL / 15 mL
Slovenian: OZNAKA NA ZAŠČITI / 15 ml
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.
Slovenian: Nekatere posnetke je zaradi atrofije s stanjšanim kortikalnim trakom (angl.: cortical ribbon), šuma na sliki ali zamegljenosti slike težko tolmačiti, zato lahko pride do napak pri interpretaciji.
English: VIZAMYL is for multidose use.
Slovenian: Zdravilo VIZAMYL je za večodmerno uporabo.
English: One multidose vial of 15-mL capacity contains 1 to 15 mL of solution, corresponding to 400 to 6000 MBq at reference date and time.
Slovenian: Ena večodmerna viala s prostornino 15 ml vsebuje 1 do 15 ml raztopine, kar ustreza 400 do 6000 MBq ob referenčnem datumu in času.
English: A negative scan indicates none or a sparse density of cortical β-amyloid neuritic plaques.
Slovenian: Negativen rezultat preiskave kaže na odsotne ali redko raztresene kortikalne β-amiloidne nevritične lehe.
English: The biophysical basis of the white matter retention of flutemetamol (18F) in the living human brain has not been definitively explained.
Slovenian: Zadrževanje flutemetamola (18F) v biofizčni osnovi bele možganovine v aktivnih človeških možganih ni bilo povsem razjasnjeno.
English: The highest level of uptake is in pons and other white matter regions.
Slovenian: Najvišja raven privzemanja je v mostu in drugih delih bele možganovine.
English: At 36 months, sensitivity of flutemetamol (18F) scans for predicting conversion from aMCI to AD in 81 converters was 64 % (95% CI: 54% to 75 %), specificity in 143 non-converters was 69% (95% CI: 60% to 76 %).
Slovenian: Po 36 mesecih je bila občutljivost posnetkov s flutemetamolom (18F) za napoved spremembe diagnoze iz aMCI v AB pri 81 bolnikih s spremenjeno diagnozo 64 % (95% IZ: 54 do 75 %), specifičnost pri 143 bolnikih, pri katerih se diagnoza ni spremenila pa 69 % (95 % IZ: 60 % do 76 %).
English: Excipients: ethanol anhydrous, polysorbate 80, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, water for injections.
Slovenian: Pomožne snovi: brezvodni etanol, polisorbat 80, natrijev klorid, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dodekahidrat, voda za injekcije.
English: One multidose vial of 10-mL capacity contains 1 to 10 mL of solution, corresponding to 400 to 4000 MBq at reference date and time.
Slovenian: Ena večodmerna viala s prostornino 10 ml vsebuje 1 do 10 ml raztopine, kar ustreza 400 do 4.000 MBq ob referenčnem datumu in času.
English: In vitro, flutemetamol (18F) binds to β-amyloid neuritic plaques in the brain, with negligible binding to neurofibrillary tangles.
Slovenian: In vitro se flutemetamol (18F) veže na β-amiloidne nevritične lehe v možganih z zanemarljivo vezavo na nevrofibrilarne vozle.
English: When in doubt, it is important to consult the nuclear medicine doctor who will supervise the procedure.
Slovenian: Če ste v dvomih, je pomembno, da se posvetujete z zdravnikom nuklearne medicine, ki nadzira postopek.
English: In the event of administration of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by frequent micturition and defecation.
Slovenian: V primeru uporabe prevelikega odmerka sevanja je treba bolnika spodbujati k povečanju izločanja iz telesa s pogostim uriniranjem in odvajanjem blata za zmanjšanje odmerka sevanja.
English: Flutemetamol (18F) binds to β-amyloid neuritic plaques in the brain.
Slovenian: Flutemetamol (18F) se veže na β-amiloidne nevritične lehe v možganih.
English: Renal/hepatic impairment The pharmacokinetics in patients with renal or hepatic impairment have not been characterised.
Slovenian: Ledvična/jetrna okvara Farmakokinetika pri bolnikih z ledvično ali jetrno okvaro ni bila določena.
English: Pharmacodynamic effects At the low concentrations present in VIZAMYL, flutemetamol (18F) has no detectable pharmacodynamic activity.
Slovenian: Farmakodinamični učinki Pri nizkih koncentracijah, ki so prisotne v zdravilu VIZAMYL, za flutemetamol (18F) ni mogoče zaznati farmakodinamičnega delovanja.
English: VIZAMYL 400 MBq/mL solution for injection flutemetamol (18F)
Slovenian: VIZAMYL 400 MBq/mL raztopina za injiciranje flutemetamol (18F)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for injection contains 400 MBq of flutemetamol (18F) at reference date and time.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml raztopine za injiciranje vsebuje 400 MBq flutemetamola (18F) na referenčni datum in čas.
English: Blood glucose decreased Blood lactate dehydrogenase increased Neutrophil count increased Respiratory rate increased
Slovenian: Preiskave zvišan krvni tlak zmanjšanje koncentracije glukoze v krvi zvišana vrednost laktatdehidrogenaze v krvi povečano število nevtrofilcev zvišana frekvenca dihanja
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.
Slovenian: Kadar ima tolmač na voljo posnetek nedavne sočasne preiskave CT ali MR, naj v primeru negotovosti glede lokacije sive možganovine in roba med sivo in belo možganovino na posnetku PET pregleda kombiniran posnetek PET-CT oziroma PET-MR, da razjasni povezavo med radioaktivnostjo PET in anatomijo sive možganovine.
English: In the 68 patients, a blinded visual patient-level PET read by 5 blinded readers resulted in a majority read sensitivity of 86% (95% CI: 72% to 95%) and specificity 92% (95% CI: 74% to 99%).
Slovenian: Pri 68 bolnikih je bila opravljena preiskava PET, vizualno slepa za bolnike in 5 odčitovalcev, ki so jo interpretirali; občutljivost je bila 86 % (95 % IZ (interval zaupanja): 72 % do 95 %) in specifičnost 92 % (95 % IZ: 74 % do 99 %) pri večini odčitavanj slik.
English: VIZAMYL may cause transient dizziness or vertigo, which may affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo VIZAMYL lahko povzroči prehodno omotico ali vrtoglavico, ki lahko vpliva na vašo sposobnost vožnje in upravljanja s stroji.
English: Talk to your nuclear medicine doctor before you are given VIZAMYL if you: have kidney problems have liver problems are pregnant or think you may be pregnant are breast-feeding
Slovenian: Opozorila in previdnostni ukrepi Preden prejmete zdravilo VIZAMYL se posvetujte z zdravnikom, če: imate težave z ledvicami imate težave z jetri ste noseči ali menite, da ste noseči dojite
English: EXPIRY DATE EXP: {hh:mm} {Time Zone} on {dd-mm-yyyy}
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: {hh:mm} {časovni pas} dne {dd-mm-llll}
English: Table 2 Estimated radiation absorbed doses from intravenous injection of VIZAMYL (adults)
Slovenian: Preglednica 2 Ocenjen absorbiran odmerek sevanja zdravila VIZAMYL (odrasli) po intravenoznem injiciranju zdravila
English: VIZAMYL is supplied in 10-mL and 15-mL Type I glass vials with halobutyl rubber stoppers and aluminium seals.
Slovenian: Zdravilo VIZAMYL je na voljo v 10-mililitrskih in 15-mililitrskih vialah iz stekla tipa I z zamaški iz halobutilne gume, zapečatenimi z aluminijasto zaporko.
English: If you have any further questions on the use of this medicine, please ask your nuclear medicine doctor who supervises the procedure.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom nuklearne medicine, ki nadzira postopek.
English: VIZAMYL has not been studied in patients with significant renal or hepatic impairment.
Slovenian: Zdravila VIZAMYL niso preučevali pri bolnikih s signifikantno okvaro ledvic ali jeter.
English: At 180 minutes, 90% of the radioactivity was present in plasma in the form of polar metabolites.
Slovenian: 180 minut po dajanju ostane v krvi manj kot 90 % injicirane radioaktivnosti v obliki polarnih presnovkov.
English: 20 minutes post-injection, 75% of the radioactivity in plasma was present as polar metabolites.
Slovenian: 20 minut po injiciranju ostane v krvi manj kot 75 % injicirane radioaktivnosti v obliki polarnih presnovkov.
English: Organ uptake Maximal flutemetamol (18F) brain uptake of approximately 7% of an injected dose occurs within two minutes of administration.
Slovenian: Privzemanje v organih Do največjega privzema flutemetamola (18F) v možganih, ki znaša približno 7 % injiciranega odmerka,
English: However, VIZAMYL may cause transient dizziness and vertigo.
Slovenian: Vendar lahko zdravilo VIZAMYL povzroči prehodno omotico in vrtoglavico.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GE Healthcare AS
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM GE Healthcare AS
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT xx.x mL YYYY MBq at reference time
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT xx,x ml YYYY MBq na referenčni čas.
English: VIZAMYL images should only be interpreted by readers trained in the interpretation of PET images with flutemetamol (18F).
Slovenian: Posnetke z uporabo zdravila VIZAMYL lahko interpretirajo le osebe, usposobljene za interpretacijo posnetkov PET s flutemetamolom (18F).
English: Of the 232 patients enrolled, 224 had at least one post-scan review by the independent committee and were included in the analysis.
Slovenian: Od 232 vključenih bolnikov je bila po slikanju pri 224
English: If you have any further questions, ask your nuclear medicine doctor who will supervise your procedure.
Slovenian: • Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom nuklearne medicine, ki bo nadzoroval postopek.
English: What VIZAMYL is and what it is used for What you need to know before VIZAMYL is used How VIZAMYL is used
Slovenian: Kaj je zdravilo VIZAMYL in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo VIZAMYL Kako uporabljati zdravilo VIZAMYL Možni neželeni učinki
English: Advanced Accelerator Applications, 47014 Meldola (FC), Italy Advanced Accelerator Applications, Technopole de l'Aube,10430 Rosières près Troyes, France Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria Instituto Tecnológico PET, SA, 28040 Madrid, Spain Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Spain Advanced Accelerator Applications, 10010 Colleretto Giacosa (TO) Italy Nucleis SA, 4000 Liège, Belgium
Slovenian: Advanced Accelerator Applications, 47014 Meldola (FC), Italija Advanced Accelerator Applications, Technopole de l'Aube,10430 Rosières près Troyes, Francija Seibersdorf Labor GmbH, 2444 Seibersdorf, Avstrija Instituto Tecnológico PET, SA, 28040 Madrid, Španija Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Španija Advanced Accelerator Applications, 10010 Colleretto Giacosa (TO), Italija Nucleis SA, 4000 Liège, Belgija
English: The activity per vial may range from 400 MBq to 4000 MBq or from 400 MBq to 6000 MBq at the reference date and time.
Slovenian: Aktivnost ene viale na referenčni datum in čas je lahko v razponu od 400 MBq do 4000 MBq ali od 400 MBq do 6000 MBq.
English: Iterative or filtered back projection reconstruction is recommended with a slice thickness of 2 to 4 mm, and an axial matrix size of 128 x 128 with pixel sizes of approximately 2 mm. Where a postsmoothing filter may be applied with a full width half maximum (FWHM) of not more than 5 mm, the filter FWHM should be chosen to optimize the signal-to-noise ratio while preserving the sharpness of the reconstructed image.
Slovenian: Priporočena je iterativna ali filtrirana povratna projekcija z debelino rezine 2 do 4 mm, velikostjo matrice 128 x 128 z velikostjo slikovnih pik približno 2 mm.
English: VIZAMYL is supplied in a 10-mL or 15-mL glass vial.
Slovenian: Zdravilo VIZAMYL je na voljo v 10 ml ali 15 ml stekleni viali.
English: A pivotal study in 68 end-of-life patients was aimed at establishing the diagnostic performance of flutemetamol (18F) to detect the cortical neuritic plaque density.
Slovenian: V klinični študiji, ki podpira vlogo za pridobitev dovoljenja za promet pri 68 bolnikih ob koncu življenja je bil namen določiti diagnostični učinek flutemetamola (18F) za določitev gostote nevritičnih leh.
English: To minimise radiation dose to the bladder, hydration before and after VIZAMYL administration should be encouraged in order to permit frequent voiding.
Slovenian: Da zmanjšate odmerek sevanja za sečni mehur, spodbujajte hidracijo, kar omogoča pogosto odvajanje urina pred in po odmerjanju zdravila VIZAMYL.
English: The recommended activity for an adult is 185 MBq of flutemetamol (18F) administered intravenously
Slovenian: Priporočena aktivnost za odraslega je 185 MBq flutemetamola (18F), apliciranega intravensko (kot bolus v roku približno 40 sekund).
English: • Information on amyloid pathology in Alzheimer Disease; relevant information on VIZAMYL as an β-amyloid PET tracer, including the approved indication according to the SmPC, limitations of VIZAMYL use, interpretation errors, safety information and the results of clinical trials informing on the diagnostic use of VIZAMYL.
Slovenian: • Podatke o patologiji amiloida pri Alzheimerjevi bolezni; relevantne podatke o zdravilu VIZAMYL, kot PET indikatorju za β-amiloid, vključno z odobreno indikacijo v skladu z
English: For each patient, the radiation exposure must be justified by the likely benefit.
Slovenian: Utemeljitev razmerja med koristmi in tveganjem pri posamezniku Pri vsakem bolniku morate izpostavljanje ionizirajočemu sevanju utemeljiti na osnovi verjetnih koristi.
English: Upper large intestine Bladder
Slovenian: Ščitnica zgornje debelo črevo mehur
English: There is no evidence of flutemetamol (18F) binding to soluble forms of
Slovenian: Ni dokazov, da se flutemetamol (18F) lahko veže s topnimi oblikami Abeta.
English: No carcinogenicity and reproductive toxicology studies have been performed with flutemetamol (18F).
Slovenian: Študije rakotvornosti in študije vpliva na sposobnost razmnoževanja s flutemetamolom (18F) niso bile opravljene.
English: VIZAMYL has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo VIZAMYL nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
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.
Slovenian: Na vsebnost alkohola (etanola) morajo biti pozorne nosečnice in doječe matere in bolniki z jetrnimi boleznimi ali epilepsijo.
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.
Slovenian: Študij farmakodinamskega medsebojnega delovanja z drugimi zdravili pri bolnikih za ugotovitev morebitnih vplivov na rezultate preiskave z uporabo zdravila VIZAMYL niso izvedli.
English: Advanced Accelerator Applications, 47014 Meldola (FC), Italy Advanced Accelerator Applications, Technopole de l'Aube,10430 Rosières près Troyes, France Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria Instituto Tecnológico PET, SA, 28040 Madrid, Spain Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Spain Advanced Accelerator Applications, 10010 Colleretto Giacosa (TO) Italy Nucleis SA, Allée du Six-Août, 8, 4000 Liège, Belgium MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finland ITEL Telecomunicazioni, Via Labriola (ZI, Lotto 40), 70037, Ruvo di Puglia, Italy Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, Bautzner Landstraβe 400, 01328 Dresden, Germany
Slovenian: Advanced Accelerator Applications, 47014 Meldola (FC), Italija Advanced Accelerator Applications, Technopole de l'Aube,10430 Rosières près Troyes, Francija Seibersdorf Labor GmbH, 2444 Seibersdorf, Avstrija Instituto Tecnológico PET, SA, 28040 Madrid, Španija Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Španija Advanced Accelerator Applications, 10010 Colleretto Giacosa (TO), Italija Nucleis SA, Allée du Six-Août, 8, 4000 Liège, Belgija MAP Medical Technologies, Saukonpaadenranta 2, 00180 Helsinki, Finska ITEL Telecomunicazioni, Via Labriola (ZI, Lotto 40), 70037, Ruvo di Puglia, Italija Helmholtz-Zentrum Dresden-Rossendorf e.V., Zentrum für Radiopharmazeutische Tumorforschung, Bautzner Landstraβe 400, 01328 Dresden, Nemčija
English: Reproductive system and breast disorders
Slovenian: Motnje reprodukcije in dojk motnje erekcije
English: Table 1 List of adverse reactions System Organ Class
Slovenian: Preglednica 1 Seznam neželenih učinkov
English: Resuming breast-feeding should be in agreement with the nuclear medicine doctor who will supervise the procedure.
Slovenian: Z dojenjem nadaljujte v dogovoru z zdravnikom nuklearne medicine, ki nadzira postopek.
English: Withdrawals should be performed under aseptic conditions.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Odvzeme je treba opravljati v aseptičnih pogojih.
English: What VIZAMYL contains The active substance is flutemetamol (18F).
Slovenian: Kaj vsebuje zdravilo VIZAMYL Učinkovina je flutemetamol (18F).
English: A recent co-registered Computed Tomography (CT) scan or Magnetic Resonance (MR) scan of the patient to obtain a fused PET-CT or PET-MR image is recommended in cases of uncertainty about the location of grey matter and of the grey/white matter border in the PET scan (see section 4.4 Interpretation of VIZAMYL images).
Slovenian: V primeru negotovosti glede lokacije sive možganovine in meje med sivo in sivo/belo možganovino na posnetku PET se priporoča tudi pregled bolnikovih nedavnih posnetkov sočasne preiskave z računalniško tomografijo (CT) ali magnetno resonanco (MR) bolnika za dosego kombiniranega PET-CT ali PET-MR posnetka (glejte poglavje 4.4.
English: Each mL of solution contains flutemetamol (18F) 400 MBq at reference date and time.
Slovenian: En ml raztopine vsebuje 400 MBq flutemetamola (18F) na referenčni datum in čas.
English: VIZAMYL is a radioactive medicinal product that emits positrons, which annihilate with electrons to produce gamma rays, and must be handled with safety measures to minimise radiation exposure to clinical personnel and patients.
Slovenian: VIZAMYL je radioaktivno zdravilo, ki oddaja pozitrone, ti pa se izničijo z elektroni in pri tem ustvarjajo gama žarke.