FrancophonIA/ELRC3.0 huggingface dataset:
English: Florbetapir (18F) is distributed throughout the body within several minutes of injection, and then is rapidly metabolised.
Slovenian: Porazdelitev Florbetapir (18F) se v nekaj minutah po injiciranju porazdeli po celem telesu, nato pa se hitro presnovi.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and single and repeated dose toxicity, in which florbetapir [the non-radioactive form of florbetapir (18F)] was used.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri enkratnem in ponavljajočih se odmerkih, pri katerih je bil uporabljen florbetapir [neradioaktivna oblika florbetapirja
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) z oddajanjem pozitronskega sevanja s 634 keV, čemur sledi fotonsko anihilacijsko sevanje s
English: You must inform the nuclear medicine doctor before you are given Amyvid if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.
Slovenian: Preden boste dobili zdravilo Amyvid, se posvetujte z zdravnikom nuklearne medicine, če obstaja možnost, da ste noseči, če vam zamuja menstruacija ali če dojite.
English: - If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom nuklearne medicine, ki bo nadziral postopek.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja pruritus urtikarija
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Splošna opozorila
English: As the effective dose is 7 mSv when the recommended activity of 370 MBq of florbetapir (18F) is administered, these adverse reactions are expected to occur with low probability.
Slovenian: Ker je pri aplikaciji priporočene aktivnosti 370 MBq florbetapirja (18F) učinkoviti odmerek 7 mSv, je možnost za pojav teh neželenih učinkov majhna.
English: (95% CI: 68.2-83.5%)
Slovenian: (95-odstotni IZ: 68,2-83,5 %)
English: Amyvid 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 Amyvid nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: A 10 minute PET image should be acquired starting approximately 30 to 50 minutes after intravenous injection of Amyvid.
Slovenian: Slikanje Desetminutno slikanje s PET začnite približno 30 do 50 minut po intravenskem injiciranju zdravila
English: It should be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease or epilepsy.
Slovenian: Vsebnost etanola upoštevajte tudi pri nosečnicah in doječih materah ter pri ogroženih skupinah, kot so bolniki z jetrnimi boleznimi ali epilepsijo.
English: In the case of an amyloid negative initial visual read and an amyloid positive quantitation,
Slovenian: a. V primeru začetnega pozitivnega amiloidnega vizualnega odčitka in negativne kvantifikacije razmislite, ali bi lahko pozitivna vizualna interpretacija temeljila na
English: In all 59 subjects, a blinded PET reading by 5 nuclear medicine physicians resulted in a majority read sensitivity of 92% (95% CI: 78-98%) and specificity of 100% (95% CI: 80-100%).
Slovenian: Pri vseh 59 preiskovancih je pet specialistov nuklearne medicine opravilo slepo odčitavanje PET-slik, pri čemer je bila občutljivost večine odčitavanj 92 % (95-odstotni IZ:
English: A PET scan with florbetapir (18F) should be requested by physicians skilled in the clinical management of neurodegenerative disorders.
Slovenian: 4.2 Odmerjanje in način uporabe PET-preiskavo s florbetapirjem (18F) mora naročiti zdravnik, usposobljen za klinično obravnavo nevrodegenerativnih bolezni.
English: 4.4 Special warnings and precautions for use
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Utemeljitev koristi in tveganj za posameznika
English: What Amyvid looks like and contents of the pack Amyvid is a clear, colourless solution for injection.
Slovenian: Zdravilo Amyvid je bistra, brezbarvna raztopina za injiciranje.
English: Amyvid 800 MBq/mL solution for injection 7.5 hours from the ToC
Slovenian: Amyvid 800 MBq/ml raztopina za injiciranje 7,5 ur od ToC
English: (95% CI: 24.1-51.9%)
Slovenian: (95-odstotni IZ: 24,1-51,9 %)
English: Injection site reactiona Infusion site rash aInjection site reaction includes injection site haemorrhage, injection site irritation, and injection site pain
Slovenian: Splošne težave in spremembe na mestu aplikacije reakcija na mestu injiciranjaa izpuščaj na mestu infundiranja aReakcija na mestu injiciranja vključuje krvavitev na mestu injiciranja, iritacijo na mestu injiciranja in bolečino na mestu injiciranja.
English: Mechanism of action Florbetapir (18F) binds to β-amyloid neuritic plaques.
Slovenian: Florbetapir (18F) se veže na ß-amiloidne nevritične lehe.
English: (95% CI: 59.9-78.1%)
Slovenian: (95-odstotni IZ: 59,9-78,1 %)
English: Resuming breast-feeding should be in agreement with the nuclear medicine doctor who will supervise the procedure.
Slovenian: Za ponovno nadaljevanje dojenja se morate dogovoriti z zdravnikom nuklearne medicine, ki bo nadzoroval postopek.
English: Read the package leaflet before use.
Slovenian: POSTOPEK UPORABE Pred uporabo preberite priloženo navodilo.
English: Advanced Accelerator Applications, 62660, Beuvry, France Advanced Accelerator Applications, 01630, Saint Genis Pouilly, France Advanced Accelerator Applications, 53121, Bonn, Germany Advanced Accelerator Applications, 10010, Colleretto Giacosa, Italy Advanced Accelerator Applications, 86077, Pozzilli, Italy Advanced Accelerator Applications, 47014, Meldola, Italy Advanced Accelerator Applications, 50100, Zaragoza, Spain Catalana de Dispensación SAU, 08950, Barcelona, Spain
Slovenian: Advanced Accelerator Applications, 62660, Beuvry, Francija Advanced Accelerator Applications, 01630, Saint Genis Pouilly, Francija Advanced Accelerator Applications, 53121, Bonn, Nemčija Advanced Accelerator Applications, 10010, Colleretto Giacosa, Italija Advanced Accelerator Applications, 86077, Pozzilli, Italija Advanced Accelerator Applications, 47014, Meldola, Italija Advanced Accelerator Applications, 50100, Zaragoza, Španija Catalana de Dispensación SAU, 08950, Barcelona, Španija
English: Pruritus Urticaria
Slovenian: Trebušna slinavka
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Intravenous use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
English: 1 vial
Slovenian: Ena viala
English: Diagnostic performance values of florbetapir (18F) PET are tabulated below:
Slovenian: Vrednosti diagnostične učinkovitosti PET-preiskave s florbetapirjem (18F) so navedene v spodnji tabeli:
English: Renal/hepatic impairment The pharmacokinetics in patients with renal or hepatic impairment have not been characterised.
Slovenian: Farmakokinetika pri bolnikih z ledvično ali jetrno okvaro ni bila določena.
English: Amyvid 1900 MBq/mL solution for injection 10 hours from the ToC.
Slovenian: Amyvid 1900 MBq/ml raztopina za injiciranje 10 ur od ToC
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/805/001 (10 mL)
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/805/001 (10 mL)
English: Advanced Accelerator Applications, 53121, Bonn, Germany Advanced Accelerator Applications, 10010, Colleretto Giacosa, Italy Advanced Accelerator Applications, 86077, Pozzilli, Italy Advanced Accelerator Applications, 47014, Meldola, Italy Advanced Accelerator Applications, 50100, Zaragoza, Spain Catalana de Dispensación SAU, 08950, Barcelona, Spain PETNET Solutions (Siemens Healthcare Limited), Nottingham, NG5 1PB, United Kingdom PETNET Solutions (Siemens Healthcare Limited), Northwood, HA6 2RN, United Kingdom PETNET Solutions, 91090, Lisses, France
Slovenian: Advanced Accelerator Applications, 10010, Colleretto Giacosa, Italija Advanced Accelerator Applications, 86077, Pozzilli, Italija Advanced Accelerator Applications, 47014, Meldola, Italija Advanced Accelerator Applications, 50100, Zaragoza, Španija Catalana de Dispensación SAU, 08950, Barcelona, Španija PETNET Solutions (Siemens Healthcare Limited), Nottingham, NG5 1PB, Velika Britanija PETNET Solutions (Siemens Healthcare Limited), Northwood, HA6 2RN, Velika Britanija PETNET Solutions, 91090, Lisses, Francija
English: If you have been given more Amyvid than you should An overdose is unlikely because you will only receive a single dose of Amyvid precisely controlled by the nuclear medicine doctor supervising the procedure.
Slovenian: Ker boste prejeli samo en odmerek zdravila Amyvid pod strogim nadzorom zdravnika nuklearne medicine, ki nadzira postopek, ni verjetno, da bi dobili prevelik odmerek.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/805/003 (10 mL)
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/805/003 (10 mL)
English: A negative scan indicates sparse or no density of cortical β-amyloid plaques.
Slovenian: Negativen rezultat preiskave kaže na redke ali odsotne kortikalne βamiloidne lehe.
English: Total body
Slovenian: Maternica Celo telo
English: Lower large intestine wall
Slovenian: Stena spodnjega debelega črevesa Tanko črevo
English: Pharmacodynamic effects At the low chemical concentrations present in Amyvid, florbetapir (18F) does not have any detectable pharmacological activity.
Slovenian: Ker je florbetapir (18F) v zdravilu Amyvid prisoten v nizki kemijski koncentraciji, nima zaznavne farmakološke aktivnosti.
English: How Amyvid will be used
Slovenian: Kako uporabljati zdravilo Amyvid
English: Gallbladder wall
Slovenian: Stena žolčnika
English: Image interpretation errors in the estimation of brain β-amyloid neuritic plaque density, including false negatives, have been observed.
Slovenian: Pri ocenjevanju gostote β-amiloidnih nevritičnih leh v možganih so opazili napake pri interpretaciji slik, vključno z lažnimi negativnimi rezultati.
English: Nervous system disorders
Slovenian: Bolezni živčevja glavobol disgevzija
English: Close contact with infants should be restricted during the initial 24 hours following injection.
Slovenian: V prvih 24 urah po injiciranju je treba omejiti bližnje stike z dojenčki.
English: (95% CI: 51.3-84.2%)
Slovenian: (95-odstotni IZ: 51,3-84,2 %)
English: Avoid any close contact with young children and pregnant women for the 24 hours following the injection.
Slovenian: 24 ur po injekciji se izogibajte bližnjim stikom z majhnimi otroki in nosečnicami.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V. 4.9 Preveliko odmerjanje
English: Red marrow
Slovenian: Rdeči kostni mozeg
English: The administration of radiopharmaceuticals creates risks for other persons (including pregnant healthcare professionals) from external radiation or contamination from spill of urine, vomiting etc.
Slovenian: zaradi izpostavljenosti zunanjemu sevanju ali kontaminacije zaradi razlitja urina, bruhanja, itd.
English: The activity per vial ranges from 800 MBq to 12000 MBq at the ToC.
Slovenian: Aktivnost na vialo ob ToC je v razponu med 800 MBq in 12000 MBq.
English: Amyvid 800 MBq/mL: One multidose vial of 10 mL capacity containing 1 to 10 mL of solution, corresponding to 800 to 8000 MBq at date and time of calibration.
Slovenian: Amyvid 800 MBq/ml: Ena večodmerna viala s prostornino 10 ml vsebuje 1 do 10 ml raztopine, kar ustreza 800 do 8000 MBq ob času kalibracije.
English: Amyvid 1900 MBq/mL: One multidose vial of 10 mL capacity containing 1 to 10 mL of solution, corresponding to 1900 to 19000 MBq at date and time of calibration.
Slovenian: Amyvid 1900 MBq/ml: Ena večodmerna viala s prostornino 10 ml vsebuje 1 do 10 ml raztopine, kar ustreza 1900 do 19000 MBq ob času kalibracije.
English: The activity per vial ranges from 1900 MBq to 28500 MBq at the ToC.
Slovenian: Aktivnost na vialo ob ToC je v razponu med 1900 MBq in 28500 MBq.
English: In vivo, correlation was assessed in end-of-life patients between florbetapir (18F) uptake in cortical grey matter and the total β-amyloid burden using 4G8 anti-amyloid antibody that stains β-amyloid found in both neuritic and diffuse plaques.
Slovenian: In vivo so povezavo med privzemom florbetapirja (18F) v kortikalni sivi možganovini in skupnim β-amiloidnim bremenom ocenjevali pri bolnikih ob koncu življenja z uporabo protiamiloidnega protitelesa
English: Amyvid contains the active substance florbetapir (18F).
Slovenian: Zdravilo Amyvid vsebuje učinkovino florbetapir (18F).
English: Close contact with infants and pregnant women should be restricted during the initial 24 hours following the injection.
Slovenian: V prvih 24 urah po injiciranju je treba omejiti bližnje stike z dojenčki in nosečnicami.
English: In the case of an amyloid positive initial visual read and negative quantitation, the physician should consider whether the positive visual interpretation might be based on tracer retention in regions outside the ROIs that contribute to the cortical average standardised uptake value ratio (SUVR).
Slovenian: Pozitivno zadrževanju sledilnika v regijah izven ROI, ki prispevajo k povprečnemu standardiziranemu razmerju vrednosti privzema v korteksu (SUVR - Standardised uptake value ratio).
English: the regions corresponding to the ROIs with elevated SUVR should be examined to determine whether there is a loss of grey/white contrast in these areas.
Slovenian: b. V primeru začetnega negativnega amiloidnega vizualnega odčitka in pozitivne amiloidne kvantifikacije preglejte regije, ki ustrezajo regijam zanimanja s povečanim SUVR, da boste ugotovili, ali gre za izgubo sivega/belega kontrasta na teh področjih.
English: Ethanol, anhydrous Sodium ascorbate Sodium chloride Water for injections
Slovenian: 6.1 Seznam pomožnih snovi etanol, brezvodni natrijev askorbat natrijev klorid voda za injekcije
English: PHARMACEUTICAL FORM Solution for injection.
Slovenian: FARMACEVTSKA OBLIKA raztopina za injiciranje Bistra, brezbarvna raztopina.
English: If you get any side effects talk to your nuclear medicine doctor.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom nuklearne medicine.
English: Maximal brain uptake of florbetapir (18F) occurs within several minutes of injection, followed by rapid brain clearance during the first 30 minutes following injection.
Slovenian: Privzem v organe Do največjega privzema florbetapirja (18F) v možgane pride v nekaj minutah po injiciranju, nato pa se v 30
English: One multidose vial of 10 mL capacity contains 1 to 10 mL of solution, corresponding to 1900 to 19000 MBq at ToC.
Slovenian: Ena večodmerna viala s prostornino 10 ml vsebuje 1 do 10 ml raztopine, kar ustreza 1900 do 19000 MBq ob ToC.
English: Kidneys
Slovenian: Dojenje
English: Amyvid 1900 MBq/mL solution for injection
Slovenian: Amyvid 1900 MBq/ml raztopina za injiciranje
English: Intravenous use
Slovenian: intravenska uporaba večodmerno
English: No animal studies have been conducted to investigate the reproductive effects of florbetapir (18F) (see section 5.3).
Slovenian: (18F) na razmnoževanje niso izvedli (glejte poglavje 5.3).
English: Each mL of solution for injection contains 800 MBq of florbetapir (18F) at date and time of calibration (ToC).
Slovenian: En mililiter raztopine za injiciranje vsebuje 800 MBq florbetapirja (18F) ob dnevu in času kalibracije (ToC).
English: Amyvid 800 MBq/mL solution for injection
Slovenian: Amyvid 800 MBq/ml raztopina za injiciranje
English: One multidose vial of 15 mL capacity contains 1 to 15 mL of solution, corresponding to 800 to 12000 MBq at ToC.
Slovenian: Ena večodmerna viala s prostornino 15 ml vsebuje 1 do 15 ml raztopine, kar ustreza 800 do 12000 MBq ob ToC.
English: One multidose vial of 15 mL capacity containing 1 to 15 mL of solution, corresponding to 800 to 12000 MBq at date and time of calibration.
Slovenian: Ena večodmerna viala s prostornino 15 ml vsebuje 1 do 15 ml raztopine, kar ustreza 800 do 12.000 MBq ob času kalibracije.
English: Amyvid 800 MBq/mL solution for injection florbetapir (18F)
Slovenian: Amyvid 800 MBq/ml raztopina za injiciranje florbetapir (18F)
English: No studies have been conducted in animals to investigate the potential long term carcinogenicity, fertility, or reproductive effects of florbetapir (18F).
Slovenian: Pri živalih niso bile opravljene nobene študije, ki bi preiskovale morebitno dolgoročno kancerogenost,
English: One multidose vial of 15 mL capacity containing 1 to 15 mL of solution, corresponding to 1900 to 28.500 MBq at date and time of calibration.
Slovenian: Ena večodmerna viala s prostornino 15 ml vsebuje 1 do 15 ml raztopine, kar ustreza 1900 do 28.500 MBq ob času kalibracije.
English: (precuneus, frontal, anterior cingulate, posterior cingulate, parietal and temporal) was measured quantitatively using standardised uptake values (SUV).
Slovenian: Pri zaključenih kliničnih preskušanjih so privzem florbetapirja (18F) v šest vnaprej opredeljenih kortikalnih možganskih območij (precuneus, frontalna skorja, sprednja cingularna vijuga, zadnja cingularna vijuga, parietalna skorja, temporalna skorja) merili količinsko s standardiziranimi vrednostmi privzema (SUVstandardised uptake values).
English: Thymus
Slovenian: Timus
English: Patients should be supine with the head positioned to centre the brain, including the cerebellum, in the PET scanner field of view.
Slovenian: Bolniki morajo ležati na hrbtu, glava pa mora biti v položaju, ki možgane, vključno z malimi možgani, postavlja v središče vidnega polja aparata za PET. Za zmanjševanje premikanja glave lahko uporabite trak ali drug fleksibilen pripomoček za omejevanje premikanja glave.
English: Of the patients who had been clinically diagnosed with MCI at study entry, 9 (19%) converted to clinical AD 36 months later.
Slovenian: Od bolnikov, ki so imeli ob vstopu v študijo klinično diagnozo zmerne kognitivne okvare, jih je 36
English: Amyvid 800 MBq/mL: 1 mL of solution for injection contains 800 MBq of florbetapir (18F) at the date and time of calibration.
Slovenian: Amyvid 800 MBq/ml raztopina za injiciranje En mililiter raztopine za injiciranje vsebuje 800 MBq florbetapirja (18F) ob času kalibracije (ToC- time of calibration).
English: One multidose vial of 15 mL capacity contains 1 to 15 mL of solution, corresponding to 1900 to 28500 MBq at ToC.
Slovenian: Ena večodmerna viala s prostornino 15 ml vsebuje 1 do 15 ml raztopine, kar ustreza 1900 do 28500 MBq ob ToC.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Slovenian: ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI Neuporabljen material zavrzite v skladu z lokalnimi predpisi.
English: One multidose vial of 10 mL capacity contains 1 to 10 mL of solution, corresponding to 800 to 8000 MBq at ToC.
Slovenian: Ena večodmerna viala s prostornino 10 ml vsebuje 1 do 10 ml raztopine, kar ustreza 800 do 8000 MBq ob
English: BATCH NUMBER Lot
Slovenian: Lot Št. viale
English: No animal toxicology and safety pharmacology studies have been performed with florbetapir (18F).
Slovenian: S florbetapirjem (18F) niso izvedli toksikoloških študij na živalih ali študij farmakološke varnosti.
English: Multidose
Slovenian: Odmerjanje
English: Amyvid 1900 MBq/mL solution for injection Amyvid 800 MBq/mL solution for injection florbetapir (18F)
Slovenian: Navodilo za uporabo Amyvid 1900 MBq/ml raztopina za injiciranje Amyvid 800 MBq/ml raztopina za injiciranje florbetapir (18F)
English: Please refer to the SmPC {SmPC should be included in the box}.
Slovenian: Glejte Povzetek glavnih značilnosti zdravila {Povzetek glavnih značilnosti zdravila mora biti priložen v škatli}.
English: Contact your nuclear medicine doctor if you have any questions.
Slovenian: Če imate kakršno koli vprašanje, se posvetujte z zdravnikom nuklearne medicine.
English: A recent co-registered computed tomography (CT) scan or magnetic resonance (MR) imaging of the patient to get 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.
Slovenian: V primeru dvomov o lokaciji sive možganovine in meje med sivo in belo možganovino na PET-posnetku se v kratkem časovnem razmaku priporoča tudi sočasno slikanje z računalniško tomografijo (CT) ali magnetno resonanco (MR), da se pridobi združeno sliko PET-CT
English: How Amyvid is stored
Slovenian: Shranjevanje zdravila Amyvid
English: Each mL of solution for injection contains 800 MBq of florbetapir (18F) at the date and time of calibration (ToC).
Slovenian: En mililiter raztopine za injiciranje vsebuje 1900 MBq florbetapirja (18F) ob dnevu in času kalibracije (ToC).
English: NAME OF THE MEDICINAL PRODUCT Amyvid 800 MBq/mL solution for injection Amyvid 1900 MBq/mL solution for injection
Slovenian: Amyvid 800 MBq/ml raztopina za injiciranje Amyvid 1900 MBq/ml raztopina za injiciranje
English: Ovaries
Slovenian: Jajčniki
English: Eli Lilly Holdings Limited atstovybė Tel. +370 (5) 2649600
Slovenian: Tel. +370 (5) 2649600
English: Dose
Slovenian: - dojite
English: Urinary bladder wall
Slovenian: Ščitnica Stena sečnega mehurja
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Amyvid 800 MBq/mL solution for injection florbetapir (18F)
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Amyvid 800 MBq/ml raztopina za injiciranje florbetapir (18F) intravenska uporaba
English: If you are pregnant
Slovenian: Če dojite
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Amyvid 1900 MBq/mL solution for injection florbetapir (18F)
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Amyvid 1900 MBq/ml raztopina za injiciranje florbetapir (18F) intravenska uporaba
English: Healthy controls show relatively low levels of florbetapir (18F) retention in cortex and cerebellum.
Slovenian: Zadrževanje florbetapirja (18F) v skorji in malih možganih pri zdravih kontrolah je razmeroma majhno.
English: Eli Lilly Nederland B.V. Papendorpseweg 83
Slovenian: Eli Lilly Nederland B.V.
English: Nausea
Slovenian: Plodnost
English: Renal impairment and hepatic impairment
Slovenian: Žilne bolezni vročinski oblivi
English: Pancreas
Slovenian: Vranica
English: Pack size
Slovenian: Velikosti pakiranja
English: NAME OF THE MEDICINAL PRODUCT Amyvid 1900 MBq/mL solution for injection florbetapir (18F)
Slovenian: Amyvid 1900 MBq/ml raztopina za injiciranje florbetapir (18F)
English: Amyvid 1900 MBq/mL: 1 mL of solution for injection contains 1900 MBq of florbetapir (18F) at the date and time of calibration.
Slovenian: Amyvid 1900 MBq/ml raztopina za injiciranje En mililiter raztopine za injiciranje vsebuje 1900 MBq florbetapirja (18F) ob ToC.
English: Upper large intestine wall
Slovenian: Stena srca Ledvice Jetra
English: Amyvid images should only be interpreted by readers trained in the interpretation of PET images with florbetapir (18F).
Slovenian: Slike z zdravilom Amyvid lahko interpretirajo le odčitovalci, usposobljeni za interpretacijo PET
English: Highest quality standards
Slovenian: Najvišji standardi kakovosti
English: The work programme of the European Medicines Agency for 2012 is influenced by a number of factors, among which are:
Slovenian: Na delovni program Evropske agencije za zdravila za leto 2012 vplivajo številni dejavniki, kot so:
English: Access to documents will remain an area that consumes significant resources.
Slovenian: Dostop do dokumentov bo ostalo področje, ki porabi precej sredstev.
English: 15 December 2011
Slovenian: 11 July 2012
English: The Agency's website will be adapted to include a single point of entry for all requests for documents or information.
Slovenian: Spletna stran agencije bo prilagojena, da bo vključevala enotno vstopno točko za vse zahtevke za dokumente ali informacije.