FrancophonIA/ELRC3.0 huggingface dataset:
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements (see section 6.6).
Slovenian: Vse neuporabljeno zdravilo ali odpadni material je treba odstraniti v skladu z lokalnimi zahtevami (glejte poglavje 6.6).
English: 47014 Meldola (FC) Italy
Slovenian: 47014 Meldola (FC) Italija
English: Children and adolescents VIZAMYL is not intended for use in children and adolescents below the age of 18 years old.
Slovenian: Otroci in mladostniki Zdravila VIZAMYL se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: If any one of these regions is clearly positive (abnormal) then the image should be classified as positive (abnormal).
Slovenian: Če je katero koli izmed teh območij jasno pozitivno (nenormalno), morate sliko oceniti kot pozitivno.
English: Via Labriola (Zona industriale Lotto 40), SNC 70037, Ruvo di Puglia (BA) Italy
Slovenian: Via Labriola (Zona industriale Lotto 40), SNC 70037, Ruvo di Puglia (BA) Italija
English: Histopathology from the pivotal study was used.
Slovenian: Uporabljena je bila histopatologija iz ključne študije.
English: Nr. 482/2 EZ98 KG 2444 Seibersdorf Austria
Slovenian: Nr. 482/2 EZ98 KG 2444 Seibersdorf Avstrija
English: The nuclear medicine doctor supervising the procedure will decide on the amount of VIZAMYL to be used in your case.
Slovenian: Zdravnik nuklearne medicine, ki nadzira postopek, se bo odločil o količini zdravila VIZAMYL, ki bo uporabljena v vašem primeru.
English: The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information.
Slovenian: Uporabljena aktivnost mora biti v vsakem primeru najmanjša možna, ki še omogoča pridobitev potrebnih diagnostičnih informacij.
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.
Slovenian: Če ste prejeli večji odmerek zdravila VIZAMYL, kot bi smeli Prevelik odmerek je malo verjeten, saj boste prejeli le en odmerek zdravila VIZAMYL, ki vam ga bo dal zdravnik nuklearne medicine v kontroliranih pogojih.
English: You should not drive, use machines or engage in other potentially hazardous activities until these effects have completely disappeared.
Slovenian: Ne vozite, ne uporabljajte strojev ter ne sodelujte v potencialno nevarnih dejavnostih, dokler ti učinki v ne izzvenijo v celoti.
English: To enable immediate action in emergencies the necessary medicinal products and equipment such as endotracheal tube and ventilator must be readily available.
Slovenian: Za takojšnje ukrepanje v nujnih primerih morajo biti na voljo nujna zdravila in oprema, kot sta na primer endotrahealni tubus in respirator.
English: Note also the medial regions where higher levels of intensity in the grey matter are seen in the positive images on the right.
Slovenian: Upoštevajte tudi medialna področja, kjer so višji nivoji intenzitete v sivi možganovini opazni na pozitivnih posnetkih na desni strani.
English: Remaining organs Effective dose (mSv/MBq)
Slovenian: Maternica ostali organi učinkovit odmerek (mSv/MBq)
English: Treatment consists of increasing the passing of urine and stools in order to help remove radioactivity from your body.
Slovenian: Zdravljenje vključuje povečanje odvajanja urina in blata kot pomoč pri odstranjevanju radioaktivnosti iz vašega telesa.
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).
Slovenian: Treba je skrbno premisliti o količini aktivnosti, namenjeni za uporabo, saj je pri teh bolnikih izpostavljenost sevanju lahko večja (glejte poglavje 4.4).
English: Expertise and qualification of trainers in both electronic and in-person training should be ensured.
Slovenian: Zagotoviti je treba znanje in usposobljenost izvajalcev usposabljanja tako pri usposabljanjih v elektronski obliki kot pri usposabljanjih v živo.
English: Extensive dose-range and adjustment studies with the medicinal product in normal and special populations have not been performed.
Slovenian: Ekstenzivne študije razpona odmerkov in prilagoditev odmerka pri normalnih in posebnih populacijah niso bile izvedene.
English: It must not be diluted.
Slovenian: Ne smete ga redčiti.
English: Advanced Accelerator Applications Technopole de l'Aube 14 rue Gustave Eiffel 10430 Rosières près Troyes France
Slovenian: Advanced Accelerator Applications Technopole de l'Aube 14 rue Gustave Eiffel 10430 Rosières près Troyes Francija
English: The usual amount recommended for an adult is 185 MBq.
Slovenian: Običajna količina, ki je priporočena za odraslo osebo, znaša 185 MBq.
English: β-Amyloid plaques are deposits sometimes present in the brains of people with dementias (such as Alzheimer's disease).
Slovenian: βamiloidne lehe so depoziti, ki včasih prisotni v možganih oseb z demencami (kot je Alzheimerjeva bolezen).
English: These are uncommon side effects and may affect up to 1 in 100 people.
Slovenian: Ti neželeni učinki so občasni in se lahko pojavijo pri največ 1 od 100 bolnikov.
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}
Slovenian: Aktivnost: 400 MBq/ml ob {hh:mm} {časovni pas} dne {dd-mm-llll} Aktivnost: LLLL MBq {ob hh:mm} {časovni pas} v {dd-mm-llll}
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).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitve rezultatov študij s flutemetamolom (18F) za vse podskupine pediatrične populacije, ker se bolezen ali stanje, za katero je določeno zdravilo namenjeno, pojavlja samo pri odraslih (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
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.
Slovenian: Ta posnetek, lahko skupaj z drugimi testi delovanja možganov vašemu zdravniku pomaga ugotoviti, ali imate v možganih β-amiloidne lehe.
English: For the limitations of use in patients with mild cognitive impairment (MCI), see section 5.1.
Slovenian: Glede omejitev uporabe pri bolnikih z zmerno kognitivno okvaro (MCI), glejte poglavje 5.1.
English: If a CT scan is simultaneously performed as part of the PET procedure, exposure to ionising radiation will increase in an amount dependent on the settings used in the CT acquisition.
Slovenian: 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.
English: Radiopharmaceuticals should be prepared in a manner that satisfies both radiation safety and pharmaceutical quality requirements.
Slovenian: Radiofarmake je treba pripraviti na način, ki bo zadoščal zaščiti pred sevanjem in tudi farmacevtskim zahtevam po kakovosti.
English: This medicinal product contains (7 vol %) of ethanol (alcohol), i.e. up to 552 mg (approximately 0.7 mL) per dose.
Slovenian: To zdravilo vsebuje (7 vol %) etanola (alkohola), to je do 552 mg (približno 0,7 ml) na odmerek.
English: This medicine is a radiopharmaceutical product for diagnostic use only.
Slovenian: To zdravilo je radiofarmacevtski izdelek in se uporablja le za diagnosticiranje.
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority.
Slovenian: Pred prihodom zdravila na trg v vsaki državi članici se mora imetnik dovoljenja za promet s pristojnim nacionalnim organom dogovoriti glede končnega izobraževalnega programa.
English: The use of VIZAMYL involves exposure to small amounts of radioactivity.
Slovenian: Uporaba zdravila VIZAMYL vključuje izpostavljenost majhnim količinam radioaktivnosti.
English: • Review of the PET reading criteria, including method of image review, criteria for interpretation, and images demonstrating the binary read methodology.
Slovenian: • Pregled kriterijev odčitavanja PET posnetkov, vključno z metodo pregledovanja, kriterije za interpretacijo in posnetke, ki pojasnjujejo binarno metodologijo odčitavanja.
English: This product will only be handled and given to you by professionals who are trained and qualified to use it safely.
Slovenian: Z zdravilom bodo ravnali in vam ga dajali le strokovnjaki, usposobljeni in kvalificirani za njegovo varno uporabo.
English: EXPIRY DATE EXP: reference time +8 h
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI EXP: referenčni čas +8 h
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.
Slovenian: 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.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
English: VIZAMYL will only be used in special controlled areas.
Slovenian: Zdravilo VIZAMYL se uporablja samo v posebno nadzorovanih prostorih.
English: Before administering radiopharmaceuticals to a mother who is breast-feeding, consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breastfeeding, and to the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk.
Slovenian: 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.
English: The patient should be encouraged to void prior to and following imaging with VIZAMYL, and frequently thereafter for the next 24 hours.
Slovenian: Bolnika spodbujajte k odvajanju urina pred in po slikanju z zdravilom VIZAMYL, in pogosto v naslednjih 24 urah.
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.
Slovenian: 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.
English: Pharmacotherapeutic group: diagnostic radiopharmaceutical, central nervous system, ATC code: V09AX04
Slovenian: Farmakoterapevtska skupina: radiodiagnostiki za ugotavljanje bolezni osrednjega živčevja, oznaka ATC: V09AX04
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.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom nuklearne medicine, preden vzamete to zdravilo.
English: Values were calculated assuming emptying of the urinary bladder at 3.5-hour intervals and human biodistribution data using OLINDA/EXM software.
Slovenian: 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.
English: 98 (42%) of the 232 patients had abnormal (positive) flutemetamol (18F) scans.
Slovenian: Pri 98 (42 %) od 232 bolnikov so bili posnetki s flutemetamolom (18F) nenormalni (pozitivni).
English: White matter - p pons and cc corpus callosum.
Slovenian: Bela možganovina - p pons in cc kalozni korpus.
English: The dose is administered by intravenous bolus injection within approximately 40 seconds.
Slovenian: Odmerek se daje z intravensko injekcijo v bolusu v trajanju približno 40 sekund.
English: VIZAMYL is used to help diagnose Alzheimer's disease and other causes of memory loss.
Slovenian: Zdravilo VIZAMYL se uporablja za diagnosticiranje Alzheimerjeve bolezni in drugih vzrokov izgube spomina.
English: Express the breast milk during this period and discard any breast milk you have expressed.
Slovenian: V tem obdobju izčrpajte mleko in vsega zavrzite.
English: The five organs/tissues with the highest cumulated activities were the wall of the small intestines, liver, urinary bladder wall, wall of the upper large intestine and the wall of the gallbladder.
Slovenian: Pet organov/tkiv z najvišjo kumulativno aktivnostjo so stene tankega črevesa, jetra, sečni mehur, stene zgornjega debelega črevesa in stene žolčnika.
English: The PET results were compared with the neuritic plaque density measured on sections of eight predefined brain regions at the patient's autopsy.
Slovenian: Rezultati PET so bili primerjani z gostoto nevritičnih leh, izmerjeno v odsekih osmih vnaprej definiranih območjih možganov pri obdukciji bolnikov.
English: The nuclear medicine doctor will only give this medicine during pregnancy if a benefit is expected which would outweigh the risks.
Slovenian: Zdravnik nuklearne medicine bo zdravilo med nosečnostjo predpisal le, če pričakovana korist odtehta tveganja.
English: Table 2 below shows the dosimetry as calculated using the OLINDA/EXM (Organ Level INternal Dose Assessment/Exponential Modeling) software.
Slovenian: V spodnji preglednici 2 je prikazano odmerjanje izračunano s programsko opremo OLINDA/EXM (Organ Level INternal Dose Assessment/Exponential Modelling).
English: INFORMATION IN BRAILLE Justification for not including Braille accepted 17.
Slovenian: PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna 17.
English: This may need to be taken into consideration by patients on a controlled sodium diet.
Slovenian: To morajo upoštevati bolniki, ki so na dieti z nadzorovanim vnosom natrija.
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.
Slovenian: 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.
English: PET images should be read using a Sokoloff, Rainbow or Spectrum colour scale.
Slovenian: Posnetke PET je treba odčitati z uporabo lestvic Sokoloff, mavrične ali barvne.
English: Method of preparation The package must be checked before use and the activity measured using a dose calibrator.
Slovenian: Način priprave Pred uporabo je treba pregledati ovojnino in s kalibratorjem odmerka izmeriti aktivnost.
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.
Slovenian: 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.
English: VIZAMYL images should be acquired starting 90 minutes after injection, using a PET scanner in 3D mode with appropriate data corrections.
Slovenian: Posnetke z uporabo zdravila VIZAMYL je treba pridobiti 90 minut po injiciranju zdravila, z uporabo skenerja PET v načinu 3D z ustreznimi popravki podatkov.
English: A brain scan is usually taken 90 minutes after VIZAMYL is given.
Slovenian: Slikanje možganov se običajno opravi 90 minut po odmerjanju zdravila VIZAMYL.
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.
Slovenian: 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.
English: If at any time in the preparation of this product the integrity of the vial is compromised, it should not be used.
Slovenian: Če je kadarkoli med pripravo zdravila integriteta viale ogrožena, je ne smete uporabiti.
English: In AD patients, cortical regions and striatal regions show significantly greater uptake compared to cortical regions in controls.
Slovenian: Pri bolnikih z AB je privzemanje v kortikalnih območjih in v območij brazd bistveno večje v primerjavi s kortikalnimi območji pri kontrolnih osebah.
English: Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary.
Slovenian: Možnost preobčutljivostne ali anafilaktične reakcije Če se pojavita preobčutljivostna ali anafilaktična reakcija, morate uporabo zdravila nemudoma prekiniti in po potrebi sprožiti intravensko zdravljenje.
English: The scan duration should typically be 20 minutes.
Slovenian: Slikanja običajno traja 20 minut.
English: Radioactive medicine
Slovenian: Radioaktivno zdravilo
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.
Slovenian: 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.
English: The negative images show a tapered intensity to the periphery of the tissue.
Slovenian: Negativni posnetki kažejo pojemajočo intenziteto v periferiji tkiva.
English: The efficacy of flutemetamol (18F) for predicting development of AD or monitoring response to therapy has not been established (see section 5.1).
Slovenian: Učinkovitost flutemetamola (18F) pri napovedovanju razvoja AB ali spremljanju odziva na zdravljenje še ni bila ugotovljena (glejte poglavje 5.1).
English: Reducing head movement with tape or other flexible head restraints may be employed.
Slovenian: Za zmanjšanje premikanja glave lahko uporabite trak ali drug fleksibilen pripomoček za omejevanje premikanja glave.
English: The apparent elimination half-life is 4.5 hours whereas the radioactive half-life of flutemetamol (18F) is 110 minutes.
Slovenian: Navidezni razpolovni čas izločanja je 4,5 ur, medtem ko je radioaktivni razpolovni čas flutemetamola (18F) 110 minut.
English: Each mL of solution contains 55.2 mg of ethanol and 4.1 mg of sodium.
Slovenian: En ml raztopine vsebuje 55,2 mg etanola in 4,1 mg natrija.
English: Note that the intensity is higher (> 60% of max) in the grey matter regions of the positive images compared to the negative images and that the intensity radiates to a sharply defined convex edge in the lateral aspects.
Slovenian: 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.
English: It is hypothesized that solubility of the radiopharmaceutical in the lipid content of brain tissues may contribute to white matter retention.
Slovenian: Domneva se, da topnost radiofarmaka v lipidni vsebini možganskih tkiv lahko prispeva k zadrževanju v beli možganovini.
English: VIZAMYL should be used in conjunction with a clinical evaluation.
Slovenian: Zdravilo VIZAMYL je treba uporabiti skupaj s kliničnim vrednotenjem.
English: Interpretation of the images is performed visually by comparing the activity in cortical grey matter with activity in adjacent cortical white matter.
Slovenian: Interpretacija posnetkov se naredi vizualno s primerjavo aktivnosti v sivi možganovini in aktivnosti v sosednji beli možganovini.
English: The activity of flutemetamol (18F) has to be measured with a dose calibrator immediately prior to injection.
Slovenian: Aktivnost flutemetamola (18F) je treba meriti s kalibratorjem odmerka tik pred injiciranjem.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: V vsaki skupini pogostosti so neželeni učinki prikazani v zaporedju padajoče resnosti.
English: The sulcal and gyral pattern is not discernible in the positive images on the right.
Slovenian: Vzorec sulkusov in girusov ni viden na pozitivnih posnetkih.
English: Do not use this medicine if you notice that the vial is damaged or the solution contains particulate matter or appears discoloured.
Slovenian: Zdravila ne uporabljajte, če opazite, da je viala poškodovana ali da so v raztopini delci ali je obarvana.
English: For precautions with respect to environmental hazard see section 6.6.
Slovenian: Za varnostne ukrepe glede nevarnosti za okolje glejte poglavje 6.6.
English: It is given to adults with memory problems before they undergo a type of brain scan called a positron-emission tomography (PET) scan.
Slovenian: Da se ga odraslim osebam, ki imajo težave s spominom, preden gredo na slikanje možganov, imenovano pozitronska emisijska tomografija (PET).
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.
Slovenian: 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.
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).
Slovenian: Ne uporabljajte zdravila VIZAMYL: Če ste alergični na flutemetamol (18F) ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Flutemetamol (18F) was positive in in vitro genotoxicity tests in bacteria and mammalian cells but negative in three different in vivo studies with sufficiently high doses.
Slovenian: 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.
English: You should discuss the results of the test with the doctor that requested the scan.
Slovenian: O rezultatih testa se pogovorite z zdravnikom, ki je slikanje predpisal.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where VIZAMYL is marketed, at launch and after launch, all physicians who are expected to use VIZAMYL have access to a training course in order to ensure accurate and reliable interpretation of the PET images.
Slovenian: 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.
English: Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus.
Slovenian: Pri postopkih z radionuklidi, ki se opravijo na nosečnicah, prejme odmerek sevanja tudi njihov plod.