natgillin/translations-raw huggingface dataset:
Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device. 
Eporatio 1000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,5 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/573/003 
Eporatio 2000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/09/573/003
Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device. 
Eporatio 3000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,5 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
EU/1/09/573/017 1 pre-filled syringe EU/1/09/573/018 1 pre-filled syringe with safety device EU/1/09/573/019 4 pre-filled syringes EU/1/09/573/020 4 pre-filled syringes with safety device EU/1/09/573/021 6 pre-filled syringes EU/1/09/573/022 6 pre-filled syringes with safety device EU/1/09/573/037 1 pre-filled syringe with safety needle EU/1/09/573/038 4 pre-filled syringes with safety needle EU/1/09/573/039 6 pre-filled syringes with safety needle 
EU/1/09/573/037 1 napolnjena injekcijska brizga z varnostno iglo EU/1/09/573/038 4 napolnjene injekcijske brizge z varnostno iglo EU/1/09/573/039 6 napolnjenih injekcijskih brizg z varnostno iglo
EU/1/09/573/006 6 pre-filled syringes with safety device EU/1/09/573/031 6 pre-filled syringes with safety needle 
EU/1/09/573/034 1 napolnjena injekcijska brizga z varnostno iglo EU/1/09/573/035 4 napolnjene injekcijske brizge z varnostno iglo EU/1/09/573/036 6 napolnjenih injekcijskih brizg z varnostno iglo
Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device. 
Eporatio 2000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,5 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
Eporatio 2,000 IU/0.5 ml injection Epoetin theta 
Eporatio 2000 i.e./0,5 ml injekcija epoetin theta s.c., i.v.
20 rue Diesel 01630 Saint Genis Pouilly FRANCE 
20 rue Diesel 01630 Saint Genis Pouilly FRANCIJA
This impact was addressed indirectly for two settings. 
Ta vpliv je bil posredno obravnavan v dveh okoliščinah.
The CHMP also agreed with this approach. 
CHMP se strinja s tem pristopom.
The Dosimetry Tables in section 11 already include calculated children's doses. 
Tabele dozimetrije v 11. poglavju že vsebujejo izračunane odmerke za otroke.
This should be carefully differentiated to diagnostic performance. 
To pa je treba natančno ločevati od diagnostične zmogljivosti.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF GLUSCAN 500 AND ASSOCIATED NAMES (SEE ANNEX I) 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA GLUSCAN 500 IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
Because no agreement was reached at Day 60, the procedure was referred to the CHMP. 
Ker do 60. dne ni bilo doseženo soglasje, je bil postopek napoten na Odbor za zdravila za uporabo v humani medicini (CHMP).
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION PRESENTED BY THE EMEA 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA POZITIVNO MNENJE, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
The CHMP assessed the dossier and the available data, including the issues raised by the objecting CMS. 
CHMP je ovrednotil dokumentacijo in razpoložljive podatke, vključno z vprašanji, ki so jih sprožile nasprotujoče zadevne države članice.
The CHMP agreed that there has been a long experience of continuous use of FDG, which support its well-established use. 
CHMP se strinja, da obstajajo dolgotrajne izkušnje neprekinjene uporabe FDG, kar podpira njeno dobro uveljavljeno uporabo.
This was mostly reported in sarcoidosis and also in vasculitis (Rehàk 2006). 
O tem so najpogosteje poročali pri sarkoidozi in tudi pri vaskulitisu (Rehàk 2006).
In addition FDG has already been registered in 3 EU Member States (EI, UK & CZ) for this “new” indication in infectious or inflammatory diseases, and the early results seen to be favourable in these countries, have been confirmed with experience of continuous use. 
Poleg tega je FDG že registrirana v 3 državah članicah EU (EI, UK in CZ) za to „novo“ indikacijo pri okužbah oz. vnetnih boleznih in prvi rezultati v teh državah, ki so veljali kot ugodni, so bili potrjeni z izkušnjami neprekinjene uporabe.
The legal basis for this application refers to: Article 10(a) of Directive 2001/83/EC, as amended - relating to applications relying on well established medicinal use supported by bibliographic literature. 
Pravna podlaga za to vlogo je člen 10(a) Direktive 2001/83/ES, kakor je bila spremenjena - o vlogah, ki se nanašajo na že uveljavljeno uporabo, ki jo podpirajo bibliografski viri.
Since FDG PET accurately diagnoses those conditions, the interference of those unavoidable therapies would certainly be considered to be minor. 
Ker PET s FDG natančno postavi diagnozo teh stanj, bi interferenca omenjenih neizogibnih terapij gotovo štela za manj pomembno.
The Applicant claims that to the best of their knowledge (at this point in time), there has been no report about leukocyte dysfunction that leads to the fact they are unable to be activated in the vicinity of targets cells. 
Predlagatelj trdi, da po njegovih zadnjih informacijah (do danes) ni bilo poročil o disfunkciji levkocitov, ki bi povzročila nezmožnost njihove aktivacije v bližini ciljnih celic.
It is also noted that FDG has been registered in childhood lymphoma for a long time, even though there were not at that time, more published data in children than currently in infection/inflammation. 
Izpostavljeno je bilo tudi, da je FDG že dolgo registriran za otroške limfome, čeprav takrat ni bilo več objavljenih podatkov pri otrocih, kot jih je trenutno za okužbo/vnetje.
The technical performance - the superiority of FDG over all radiopharmaceutical comparators has been documented in articles, and is applicable to all the proposed settings of these indications. 
Tehnična zmogljivost - superiornost FDG nad vsemi primerljivimi radiofarmaki je dokazana v člankih in se nanaša na vse predlagane okoliščine teh indikacij.
By this substitution of gallium-67 by FDG, radiation exposure is reduced by a factor 3-5, which is of major significance in children with benign conditions. 
Če zamenjamo galij67 s FDG se izpostavitev sevanju zmanjša za faktor 3-5, kar je zelo pomembno za otroke z benignimi boleznimi.
This has been confirmed in 2000 by Meller: “Antibiotic and immunosuppressive therapy did not seem to influence the results of FDG scanning, as 66% of the patients who were treated exhibited a pathological uptake that clarified the cause of fever.” 
To je leta 2000 potrdil Meller: „Videti je, da antibiotično in imunosupresivno zdravljenje ne vplivata na rezultate tomografije s FDG, saj smo pri 66 % zdravljenih bolnikov ugotovili patološki privzem, ki je pojasnil vzrok zvišane telesne temperature.“
Most data have been obtained with PET alone and are therefore still valid; one could only consider that they would represent the minimum performance that could be anticipated with PET/CT. 
Večina podatkov je pridobljenih samo s PET in so še vedno veljavni; predpostavlja se lahko le, da predstavljajo najmanjšo zmogljivost, ki jo pričakujemo od preiskave PET/CT.
The CHMP agreed that the clinical efficacy (diagnostic performance and impact on diagnostic thinking) of PET/PET-CT with FDG had been adequately demonstrated. 
CHMP se je strinjal, da je klinična učinkovitost (diagnostična zmogljivost in vpliv na diagnostično razmišljanje) preiskave PET/PET-CT s FDG zadostno dokazana.
The quality of the studies that have been retained for the analysis, after many other have been discarded, has been confirmed in published meta-analysis or recent review articles, in several settings. 
Kakovost študij, ki so bile izbrane za analizo po izločitvi številnih izmed njih, je bila potrjena v različnih okoliščinah v objavljeni metaanalizi ali nedavnih časopisnih recenzijah.
As radiation protection is a part of safety, it is also noted that, although all the registered diagnostic radiopharmaceuticals are globally safe, FDG is thought to be among the safest, and much less irradiating than gallium-67 or indium-111. 
Ker je varovanje pred sevanjem del varnosti, je poudarjeno tudi, da kljub splošni varnosti vseh registriranih diagnostičnih radiofarmakov FDG šteje med najvarnejše in da seva veliko manj kot galij67 in indij-111.
In a large majority of FDG studies published in oncology, cases of infection/inflammation have been reported as a source for false-positive findings: those FDG foci did not correspond to malignant tissue. 
V veliki večini študij FDG, objavljenih na področju onkologije, so primeri okužb/vnetja navedeni kot vir lažno pozitivnih odkritij: žarišča FDG niso ustrezala malignemu tkivu.
The CHMP therefore agreed that the paediatric population aged less than 18 years should be included in the SmPC. 
CHMP se zato strinja, da se pediatrično populacijo, mlajšo od 18 let, vključi v povzetek glavnih značilnosti zdravila.
In this setting, Walter (2005) reported a detection rate of pathological large vessel of 8/9=89% without treatment vs. 10/21=48% with corticosteroids. 
Walter (2005) je ugotovil, da je v teh okoliščinah stopnja odkritja patološke velike žile 8/9=89 % brez zdravljenja in 10/21=48 % z zdravljenjem s kortikosteroidi.
The CHMP therefore agreed that the current wording of the SmPC concerning the use in children is adapted also for infection/inflammation (by deleting the word “oncology”). 
CHMP se je zato strinjal, da se trenutno besedilo povzetka glavnih značilnosti zdravila o uporabi pri otrocih prilagodi tudi za okužbo/vnetje (s črtanjem besede „onkologija“).
Mahfouz (2005) performed 2,631 FDG-PET examinations in 1,110 patients with multiple myeloma for cancer staging and/or for the diagnosis of suspected infection. 
Mahfouz (2005) je opravil 2 631 preiskav PET s FDG pri 1 110 bolnikih z multiplim mielomom zaradi razvrščanja raka in/ali diagnoze suma o okužbi.
However this is not the case for FDG which targets in vivo foci of activated leukocytes. 
Vendar to ni težava pri uporabi FDG, ki je usmerjena v žarišča aktiviranih levkocitov in vivo.
It is clear that FDG is able to detect infection/inflammation as an incidental finding in patients referred for cancer. 
Jasno je, da FDG zmore nenamerno odkriti okužbe/vnetja pri bolnikih, napotenih zaradi raka.
The CHMP therefore does not see the need for additional information to support the use of this technique in the ten requested infectious and inflammatory diseases and the proposed posology in these indications. 
CHMP se zato dodatni podatki v podporo uporabi te tehnike za deset želenih okužb in vnetij ter predlaganemu odmerjanju pri teh indikacijah ne zdijo potrebni.
The CHMP therefore acknowledged that the technical performance and procedural convenience of FDG are of overall benefit in this indication. 
Zaradi je tega CHMP potrdil, da sta tehnična zmogljivost in prikladnost postopka s FDG na splošno koristna za to indikacijo.
Gluscan is intended to be used in the oncological, cardiological, neurological indications and infectious or inflammatory diseases. 
Zdravilo Gluscan je namenjeno za onkološke, kardiološke in nevrološke indikacije ter za okužbe oz. vnetne bolezni.
Corticosteroids have been shown to decrease profoundly or suppress FDG uptake. 
Dokazano je, da privzem FDG izrazito zmanjšajo ali zavrejo kortikosteroidi.
The use of PET-CT is a matter of equipment of the PET centre and of professional guidelines (including the above mentioned Euratom Directive defining justification and optimisation of the irradiation), and does not need to be addressed in the SmPC, except when PET-CT has been shown to increase efficacy. 
Uporaba PET-CT je odvisna od opremljenosti PET-središča ter strokovnih smernic (vključno z zgoraj omenjeno direktivo Euratom, ki opredeljuje upravičenost in optimizacijo sevanja), zato je ni treba obravnavati v SmPC, razen v primerih, kjer je dokazano, da PET-CT poveča učinkovitost.
The inconveniences and risks of 99mTc HMPAO in vitro labelled leukocytes are obvious: withdrawal of a large quantity of blood in a child for in vitro labelling and anaphylaxia. 
Neprijetnosti in tveganja ob uporabi levkocitov, označenih s 99mTc HMPAO in vitro, so očitne: odvzem velike količine krvi otroku za označevanje in vitro in anafilaksija.
The safety data for the combined PET/CT technology does not differ from that of PET; the only difference being an increase in radiation dose, due to the low dose CT, which produces no detectable consequence. 
Varnostni podatki kombinirane tehnologije PET/CT se ne razlikujejo od preiskave PET. Edina razlika je povečan odmerek sevanja zaradi nizkoodmerne preiskave CT, ki pa nima zaznavnih posledic.
It is intended to be used in patients with infectious or inflammatory diseases in the proposed settings. 
Zdravilo je namenjeno uporabi pri bolnikih z okužbami oz. vnetnimi boleznimi v predlaganih okoliščinah.
It should be borne in mind that the pharmacodynamic effects of these drugs (e.g. corticosteroids) on leukocytes that are taking-up FDG is identical in all settings, and that there is no need for a setting-by-setting demonstration of the interference, even though the consequence on diagnostic thinking may be different from one setting to another. 
Upoštevati je treba, da so farmakodinamični učinki teh zdravil (npr. kortikosteroidov) na levkocite, ki privzemajo FDG, enaki v vseh okoliščinah, zato dokaz interference ni potreben v vsaki okoliščini, čeprav se posledice diagnostičnega razmišljanja v okviru okoliščin razlikujejo.
GLUSCAN 500 500MBq/mL at calibration time 
GLUSCAN 500 500 MBq/mL v času kalibracije
The Applicant also refers to some specific studies that have been performed for IBD (Lemberg 2005, Löffler 2006) in a total of 88 patients, and for chronic granulomatous disease with a gut lesion in 5 of the 7 patients of Güngör (2001), and to some children who have also been included in a series with other conditions (e.g. 13 children with FUO). 
Predlagatelj se tudi sklicuje na nekatere specifične študije, ki so bile opravljene pri skupno 88 bolnikih z aktivno vnetno boleznijo črevesja (Lemberg 2005, Löffler 2006) in petih od sedmih bolnikov s kronično granulomatozno boleznijo z lezijo črevesja v študiji Güngörja (2001) ter nekaterih otrocih, ki so bili vključeni v nize z drugimi boleznimi (npr. 13 otrok z zvišano telesno temperaturo neznanega vzroka).
Thus the benefit/risk ratio is clearly favourable for FDG than for any of the other registered radiopharmaceuticals in the requested indication ‘Infectious and inflammatory diseases'. 
Zato je razmerje koristnih učinkov in tveganja FDG bistveno boljše kot pri katerem koli od registriranih radiofarmakov za želeno indikacijo „Okužbe in vnetne bolezni“.
The first publication of a series in 7 patients with sarcoidosis dates from 1994 and a total of 1988 patients have been reported in published series for EU series from 1999 to 2009. 
Prva objava niza 7 bolnikov s sarkoidozo je iz leta 1994, od leta 1999 do leta 2009 pa je bilo v objavljenih nizih iz EU skupno 1 988 bolnikov.
For the effect of a decrease in leukocytes counts in patients with leukocyte dysfunction, it has been demonstrated in myeloma patients (Mahfouz (2005)), that “FDG-PET can be diagnostic in the setting of severe neutropenia, unlike most other nuclear imaging techniques”. 
V zvezi z učinkom zmanjšanja ravni levkocitov pri bolnikih z disfunkcijo levkocitov so pri bolnikih z mielomom (Mahfouz (2005)) dokazali, da „je preiskava PET s FDG v nasprotju s tehnikami nuklearnega slikanja lahko diagnostična v primerih hude nevtropenije“.
Gluscan is a radiopharmaceutical medicinal product composed of fludeoxyglucose (18F), abbreviated as FDG. 
Gluscan je radiofarmak, sestavljen iz fludeoksiglukoze (18F), skrajšano FDG.
A high overall impact on patient management has been reported for the overall indication and for every specific disease. 
Poročajo o visokem skupnem vplivu na obravnavo bolnika za skupno indikacijo in za vse posamezne bolezni.
A perfect positive predictive value (PPV) and a considerable impact on management were reported. 
Ugotovili so idealno pozitivno napovedno vrednost in bistven vpliv na zdravljenje bolnika.
- satisfactory consideration has been given to situations such as patients with immunodeficiency, with leukocyte dysfunction and patients under specific concomitant medications affecting the viability and/or function of leukocytes (such as antibiotics, non-steroid anti-inflammatory drugs, etc) 
- primerna obravnava je bila namenjena okoliščinam, ki vključujejo bolnike z imunskimi pomanjkljivostmi, disfunkcijo levkocitov in bolnike s specifičnimi sočasno uporabljenimi zdravili, ki vplivajo na viabilnost in/ali funkcijo levkocitov (kot so antibiotiki, nesteroidna protivnetna zdravila itn.)
A technique for specific imaging of tissues or structures with an abnormal content of activated white blood cells is likely to provide important information in the management of patients with infectious and inflammatory diseases. 
Tehnika za specifično slikanje tkiv ali struktur z nenormalno vsebnostjo aktiviranih levkocitov verjetno omogoča podatke, ki so pomembni za zdravljenje bolnikov z okužbami oz. vnetnimi boleznimi.
Fludeoxyglucose (18F) is a glucose analogue which is accumulated in all cells using glucose as a primary energy source. 
Fludeoksiglukoza (18F) je glukozni analog, ki se kopiči v vseh celicah, ki porabljajo glukozo kot primarni vir energije.
The particularity of the present application is that the proposed indication in infectious or inflammatory diseases is currently not part of the core SPC for FDG. 
Posebnost te vloge je, da predlagana indikacija okužb oz. vnetnih bolezni trenutno ni del temeljnega povzetka glavnih značilnosti zdravila za FDG.
Concerning the diagnostic efficacy of fludeoxyglucose (18F) in patients with immunodeficiency, the Applicant has provided data from literature that demonstrates that FDG PET is effective in AIDS patients to detect malignancies and/or infectious disease. 
Predlagatelj je v zvezi z diagnostično zmogljivostjo fludeoksiglukoze (18F) pri bolnikih z imunsko pomanjkljivostjo predložil podatke iz literature, ki dokazujejo, da je preiskava PET s FDG učinkovita pri odkrivanju malignih bolezni in/ali okužb pri bolnikih z aidsom.
These indications were each based on a biological process, i.e. glucose uptake by specific organs or tissues: increased uptake by the malignant cells, persistent uptake by the viable jeopardised myocardial cells and decreased uptake by the neurons of the cortex responsible for promoting epilepsy when patient is not presenting with a crisis. 
Te indikacije temeljijo na biološkem procesu, tj. privzemu glukoze v specifičnih organih ali tkivih: povečan privzem v maligne celice, trajen privzem v viabilne, ogrožene miokardne celice ter zmanjšan privzem v nevrone korteksa, ki je odgovoren za pospeševanje epilepsije, ko bolnik ni v krizi.
It is obvious that in vitro labelling of circulating WBC, which is requested with some of the comparators (111In oxine or 99mTc HMPAO labelled WBC) is impeded by a poor leukocytes count. 
Jasno je, da označevanje krožečih levkocitov in vitro, ki je potrebno pri nekaterih primerjalnih zdravilih (z 111In oksinom ali 99mTc HMPAO označeni levkociti), ovira nizka raven levkocitov.
GLUSCAN PL 500MBq/mL at calibration time 
GLUSCAN PL 500 MBq/mL v času kalibracije
Conversely this is not a contra-indication as the non-attenuation corrected images of PET remain artefact-free. 
Vendar to ni kontraindikacija, saj so slike PET, ki niso korigirane z atenuacijo, brez artefaktov.
The quality of data used for assessment of efficacy has been checked (homogeneity of the series in a given setting according to explicit inclusion criteria, images acquired according to an accepted protocol available for FDG and also for the comparator in comparative studies and description of the standard of truth obtained in all evaluable patients, except in case of a study of the impact on management only) and shown to be in line with the requirements of the Points to Consider (PtC) on the Evaluation of Diagnostic Products (CPMP/EWP/1119/98). 
Preverjena je bila kakovost podatkov, uporabljenih za vrednotenje učinkovitosti (homogenost nizov v določenih okoliščinah glede na jasno določene vključitvene kriterije, slike, pridobljene s sprejetim protokolom za FDG in za primerjalno zdravilo v primerjalnih študijah ter opis standarda resnice, pridobljenega pri vseh ocenljivih bolnikih, razen v študiji vpliva na obravnavo), in ugotovljeno je bilo, da je skladna z zahtevami dokumenta „Vidiki, ki jih je treba upoštevati pri vrednotenju diagnostičnih zdravil“ (CPMP/EWP/1119/98).
The subheading ‘Population aged less than 18 years' under the section 4.2 Posology and method of administration has been amended, and the word “oncologic” has been deleted. 
V poglavju 4.2 Odmerjanje in način uporabe je bil dopolnjen podnaslov „Bolniki, mlajši od 18 let“, črtana pa je bila beseda „onkološki“.
In this setting CT is of poor help due to artefacts induces by beam hardening in the vicinity of the metallic prosthesis. 
V tem primeru je CT manj uporaben zaradi artefaktov, ki jih povzroči otrditev žarka v bližini kovinskih protez.
In the particular case of myeloma (which is now considered part of lymphoma) and indicates FDG as such, FDG has been deliberately used to search for infection prior to starting chemotherapy, in relation with the depletion of immunity and WBC. 
V specifičnem primeru mieloma (ki zdaj šteje kot del limfomov), ki indicira FDG kot tako, so s FDG namenoma iskali okužbo pred začetkom kemoterapije pri bolnikih z zmanjšano imunostjo in nizkimi ravnmi levkocitov.
- the use of Gluscan can be recommended in children also, for indications of infectious and inflammatory diseases 
- uporabo zdravila Gluscan se lahko priporoči tudi za indikacije okužb in vnetnih bolezni pri otrocih
Furthermore, the 99mTc HMPAO in vitro labelled leukocytes are not indicated for the whole spectrum covered by FDG, since non-circulating WBC involved in many chronic infectious and inflammatory conditions are not labelled, and the background in the bone marrow is high, impeding detection of foci in the axial skeleton. 
Poleg tega pa levkociti, označeni s 99mTc HMPAO in vitro, niso indicirani za celoten razpon bolezni, ki ga pokriva FDG, saj nekrožeči levkociti, ki sodelujejo pri veliko kroničnih okužbah in vnetjih niso označeni, zato je signal ozadja iz kostnega mozga močan, kar otežuje odkrivanje žarišč v aksialnem skeletu.