FrancophonIA/ELRC3.0 huggingface dataset:
English: If PRCA is diagnosed, therapy with epoetin theta must be discontinued and patients should not be switched to another recombinant epoetin (see section 4.4).
Maltese: Jekk PRCA tiġi ddijanjostikata, it-terapija b'epoetin theta trid titwaqqaf u l-pazjenti m'għandhomx jinqalbu għal epoetin rikombinanti ieħor (ara sezzjoni 4.4).
English: 20 rue Diesel 01630 Saint Genis Pouilly FRANCE
Maltese: Advanced Accelerator Applications 20 rue Diesel 01630 Saint Genis Pouilly
English: GLUSCAN 500 500MBq/mL at calibration time
Maltese: GLUSCAN 500 500MBq/mL f'ħin ta' kalibrazzjoni
English: GLUSCAN PL 500MBq/mL at calibration time
Maltese: GLUSCAN PL 500MBq/mL f'ħin ta' kalibrazzjoni
English: 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.
Maltese: F'dan l-isfond, Walter (2005) irrapporta rata ta' skoperta ta' kanali trasportaturi kbar patoloġiċi ta' 8/9=89% mingħajr kura kontra 10/21=48% bilkortikosterojdi.
English: 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.
Maltese: Mahfouz (2005) wettaq 2,631 eżami FDG-PET f'1,110 pazjenti b'majeloma multipla għall-istadji talkanċer u/jew għad-dijanjożi ta' infezzjoni suspettata.
English: Water for injection - 1.00g, Sodium citrate - 0.62% (v/v), Sodium chloride - 0.41% (v/v), Hydrochloric acid 0.39% (v/v), Ethanol 0.31% (v/v)
Maltese: 41% (v/v), Aċidu idrokloriku 0.39% (v/v), Etanol 0.31% (v/v) Sodju idrossidu 0.24% (v/v)
English: The issue was referred to the CMD(h) and an assessment was carried out by the RMS.
Maltese: Il-kwistjoni ġiet riferuta lis-CMD(h) u twettqet evalwazzjoni millRMS.
English: 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.
Maltese: Lewwel pubblikazzjoni ta' serje f'7 pazjenti b'sarkojdożi ġġib id-data tal-1994 u total ta' 1988 pazjent ġew irrapportati f'serje ippubblikata għal serje tal-UE mill-1999 sal-2009.
English: - the body of evidence on infectious or inflammatory diseases considered in the evaluation of this wellestablished use dossier is a careful selection of the studies according to the criteria of the Points to Consider (PtC) on the Evaluation of Diagnostic Products (CPMP/EWP/1119/98) and limited to the best documented clinical settings
Maltese: - l-ġabra ta' provi dwar mard infettiv jew infjammatorju kkunsidrata fl-evalwazzjoni ta' dan iddossier ta' użu stabbilit sewwa hija għażla attenta tal-istudji skont il-kriterji tal-Punti li għandhom jiġu Kkunsidrati (PtC) dwar l-Evalwazzjoni ta' Prodotti Dijanjostiċi (CPMP/EWP/1119/98) u limitata għall-isfondi kliniċi l-aktar dokumentati
English: The impact on management was as obvious as in adults (FUO, IBD) and even more striking in the case of granulomatosis (Güngör 2001).
Maltese: L-impatt fuq l-immaniġġjar kien ovvju daqs l-impatt fl-adulti (FUO, IBD) u aktar impressjonanti fil-każ tal-granulomatożi (Güngör 2001).
English: 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.
Maltese: Huwa ovvju li t-tikkettjar in vitro ta' WBC li jiċċirkolaw, li huwa meħtieġ għal xi wħud mill-komparaturi (111F'WBC tikkettjati bloxine jew b'99mTc HMPAO) ma jitħalliex isir minħabba numru fqir ta' lewkoċiti.
English: 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.
Maltese: B'din is-sostituzzjoni ta' gallium-67 b'FDG, l-espożizzjoni għar-radjazzjoni titnaqqas b'fattur ta' 3-5, li hija ta' sinifikat kbir fi tfal b'kundizzjonijiet beninni.
English: 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.”
Maltese: Dan ġie kkonfermat fis-sena 2000 minn Meller: “Il-kura antibijotika u immunosuppressiva ma dehritx li influwenzat ir-riżultati tal-iskenjar FDG, minħabba li 66% tal-pazjenti li ġew ikkurati urew teħid patoloġiku li ċċara l-kawża tad-deni.”
English: 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.
Maltese: Il-bażi legali għal din l-applikazzjoni tirreferi għal: Artikolu 10(a) tad-Direttiva 2001/83/KE, kif emendata - relatata mal-applikazzjonijiet li jibbażaw fuq l-użu mediċinali stabbilit sew appoġġjat minn letteratura bibljografika.
English: It was concluded that: that the intrinsic resolution of a PET scanner is twice as good as that of a gamma-camera with a low energy collimator used for technetium-99m and more than twice with a medium energy collimator used for gallium-67 or indium-111, that the waiting time for the patient (1h between injection and image acquisition) is the shortest of all registered radiopharmaceuticals in this field, that the other inconveniences/risks for the patient are less than those of gallium-67 (cumbersome patient preparation) or of labelled white blood cells (WBC) which requires withdrawal of a large quantity of blood and encompasses risk of errors in re-injection; that the dosimetry of FDG PET is similar to that of technetium-99m labelled products and more favourable than that of gallium-67 or indium-111 radiopharmaceuticals.
Maltese: Ġie konkluż: li r-riżoluzzjoni intrinsika ta' skaner PET hija tajba d-doppju ta' dik ta' kamera gamma b'kollimatur b'enerġija baxxa użat għal technetium-99m u aktar mid-doppju b'kollimatur b'enerġija medja użat għal gallium-67 jew indium-111, li ż-żmien ta' stennija għall-pazjent (siegħa bejn it-titqiba u l-kisba tal-immaġini) huwa l-iqsar għar-radjufarmaċewtiċi kollha rreġistrati f'dan il-qasam, li l-inkonvenjenzi/riskji l-oħrajn għall-pazjent huma inqas minn dawk ta' gallium-67 (tħejjija skomda tal-pazjent) jew minn dawk ta' ċelloli tad-demm bojod tikkettjati (WBC) li jeħtieġ itteħid ta' kwantità kbira ta' demm u jinkludi r-riskju ta' żbalji fit-titqib mill-ġdid; li d-dożimetrija tal-FDG PET hija simili għal dik ta' prodotti tikkettjati technetium-99m u aktar favorevoli minn dik ta' radjufarmaċewtiċi gallium-67 jew indium-111.
English: Fludeoxyglucose (18F) is accumulated in tumours with a high glucose turnover.
Maltese: Fludeoxyglucose (18F) jinġema' fit-tumuri b'ammont għoli ta' glucose.
English: 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”.
Maltese: Bil-għan li jitnaqqis l-għadd ta' lewkoċiti f'pazjenti b'disfunzjoni tal-lewkoċite, intwera f'pazjenti b'mijeloma (Mahfouz (2005)), li “FDG-PET jista' jkun dijanjostiku fl-isfond ta' newtropenja severa, mhux bħall-parti l-kbira tat-tekniki nukleari ta' teħid ta' immaġini oħra”.
English: Fludeoxyglucose (18F) passes the blood-brain barrier, and epileptogenic foci exhibit a reduced glucose metabolism in the seizure free phases.
Maltese: Fludeoxyglucose (18F) jgħaddi mill-barriera ta' bejn id-demm u l-moħħ, u fokijiet epilettoġeniċi juru metaboliżmu mnaqqas tal-glucose fil-fażijiet ħielsa minn attakki.
English: A paragraph highlighting the effect of corticosteroids on FDG uptake in the infection and inflammation indication, and consideration of the possible temporary withdrawal of this therapy was proposed by a CMS in section 4.5 of the SmPC (Intercation with other medicinal products and other forms of interaction), and was subsequently endorsed by the CHMP.
Maltese: Paragrafu li jenfasizza l-effett tal-kortikosterojdi fuq it-teħid tal-FDG fl-indikazzjoni tal-infezzjoni u tal-infjammazzjoni, u l-ikkunsidrar tat-twaqqif temporanju possibbli ta' din il-kura ġie propost mis-CMS fis-sezzjoni 4.5 tal-SmPC (Prodotti mediċinali oħra li ma jaqblux ma' dan il-prodott u affarijiet oħra li jistgħu jibdlu l-effett farmaċewtiku tal-prodott), u sussegwentement ġie approvat mis-CHMP.
English: Although it is argued that the effective dose of irradiation from 99mTc labelled compounds is similar to that of FDG, the easiest to use 99mTc labelled comparator, immunoscintigraphy, is contraindicated in children for a well documented reason; that the occurrence of antibodies will impede further use.
Maltese: Għalkemm huwa argumentat li d-doża effettiva ta' irradjazzjoni minn komposti tikkettjati 99mTc hija simili għal dik ta' FDG, il-komparatur tikkettjat 99mTc li huwa l-aktar wieħed faċli biex jintuża,
English: 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.
Maltese: Is-sottotitlu ‘Popolazzjoni li għandha inqas minn 18-il sena' taħt is-sezzjoni 4.2 Pożoloġija u metodu ta' kif għandu jingħata ġie emendat, u l-kelma “onkoloġiku” tneħħiet.
English: The three indications oncology, cardiology and neurology are established in the core SmPC for this active substance.
Maltese: It-tliet indikazzjonijiet onkoloġija, kardjoloġija u newroloġija huma stabbiliti fl-SmPC ewlieni ta' din is-sustanza attiva.
English: 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).
Maltese: Il-kwalità tad-dejta użata għall-evalwazzjoni tal-effikaċja ġiet iċċekjata (omoġeneità tas-serje fi sfond partikolari skont kriterji ta' inklużjoni espliċiti, immaġnijiet miksuba skont protokoll aċċettat disponibbli għall-FDG kif ukoll għall-komparatur fi studji komparattivi u deskrizzjoni tal-istandard tal-verità miksub fil-pazjenti evalwabbli kollha, ħlief f'każ ta' studju tal-impatt fuq l-immaniġġjar biss) u ntweriet li kienet f'konformità mar-rekwiżiti tal-Punti li għandhom jiġu Kkunsidrati (Points to Consider - PtC) dwar l-Evalwazzjoni ta' Prodotti Dijanjostiċi (CPMP/EWP/1119/98).
English: The medical records of the 248 patients with multiple myeloma whose FDG-PET was reported as showing increased radiotracer uptake at extramedullary sites and/or bone and joint lesions (that would be atypical for multiple myeloma) were reviewed, to identify cases associated with infection.
Maltese: Ġew riveduti r-rekords mediċi tal-248 pazjent b'majeloma multipla li l-FDG-PET tagħhom kien irrappurtat li wera teħid ta' radjotraċċatur akbar f'postijiet ekstramedullari u/jew leżjonijiet tal-għadam u tal-ġogi (li mhumiex tipiċi għal majeloma multipla), biex jiġu identifikati każijiet assoċjati ma' infezzjoni.
English: 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).
Maltese: L-Applikant jirreferi wkoll għal xi studji speċifiċi li saru għall-IBD (Lemberg 2005, Löffler 2006) f'total ta' 88 pazjent, u għall-marda granulomatika kronika b'leżjoni tal-intestin f'5 mis-7 pazjenti ta' Güngör (2001), u għal xi tfal li wkoll ġew inklużi f'serje b'kundizzjonijiet oħrajn (eż. 13-il tifel u tifla b'FUO).
English: The posology (in fact the injected activity) recommended in the Core SmPC, 100-400MBq with adaptation in children, is in line with the activity used in the reported clinical studies for infection/inflammation, whatever the machine used PET, CDET or PET-CT. No adaptation is necessary according to the clinical setting, while an adaptation is necessary (within the above range) according to the body weight of the patient and the type of PET(/CT) machine used for imaging.
Maltese: Il-pożoloġija (fil-fatt l-attività injettata) rakkomandata fl-SmPC Ewlieni, 100-400MBq b'addattament fit-tfal, hija konformi mal-attività użata fl-istudji kliniċi rrapportati għall-infezzjoni/infjammazzjoni, tkun xi tkun il-magna użata PET, CDET jew PET-CT.
English: This was mostly reported in sarcoidosis and also in vasculitis (Rehàk 2006).
Maltese: Dan ġie rrappurtat l-aktar f'sarkojdożi kif ukoll fil-vaskulite (Rehàk 2006).
English: As mentioned above, it would be against the optimisation principle of the Euratom Directive (implemented in the law of all EU Member States) to exclude children from the benefit of FDG PET in infectious/inflammatory diseases, since the other scintigraphic options are actually more irradiating for the child (gallium-67 scintigraphy, indium-111 WBC scintigraphy) or for the personnel (in vitro labelling with technetium-99m HMPAO), without any benefit in efficacy.
Maltese: Kif intqal hawn fuq, ikun kontra l-prinċipju ta' ottimizzazzjoni tad-Direttiva tal-Euratom (implimentata fil-liġi tal-Istati Membri kollha tal-UE) li wieħed jeskludi t-tfal mill-benefiċċju ta' FDG PET f'mard infettiv/infjammatorju, minħabba li l-opzjonijiet sintigrafiċi l-oħrajn huma aktar irradjanti għat-tfal (sintigrafija gallium-67, sintigrafija tal-WBC indium-111) jew għall-persunal (tikkettjar in vitro b'technetium-99m
English: Overall 6125 patients worldwide have to date been reported in published series (excluding cases reports) who benefited from FDG PET indicated for inflammation/and infection (excluding incidental findings of infection/inflammation in patients referred for another indication).
Maltese: B'kollox, 6125 pazjent madwar id-dinja sal-lum ġew irrapportati f'serje ippubblikata (li teskludi rapporti ta' każijiet) li bbenefikaw mill-FDG PET indikat għall-infjammazzjoni/u għall-infezzjoni (esklużi sejbiet inċidentali ta' infezzjoni/infjammazzjoni f'pazjenti riferuti għal indikazzjoni oħra).
English: The CHMP agreed that the clinical efficacy (diagnostic performance and impact on diagnostic thinking) of PET/PET-CT with FDG had been adequately demonstrated.
Maltese: Is-CHMP qabel li l-effikaċja klinika (prestazzjoni dijanjostika u impatt fuq il-ħsib dijanjostiku) talPET/PET-CT b'FDG intweriet b'mod adegwat.
English: - the technical performance has been documented in articles, and is applicable to all the proposed infectious or inflammatory diseases
Maltese: - il-prestazzjoni teknika ġiet iddokumentata f'artikli, u hija applikabbli għall-mard infettiv u infjammatorju propost kollu
English: 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.
Maltese: L-użu tal-PET-CT hija kwistjoni ta' tagħmir taċ-ċentru PET u ta' linji gwida professjonali (inkluża dDirettiva tal-Euratom imsemmija hawn fuq li tiddefinixxi l-ġustifikazzjoni u l-ottimizzazzjoni talirradjazzjoni), u ma jeħtieġx li jkun indirizzat fl-SmPC, ħlief meta l-PET-CT jintwera li jżid leffikaċja.
English: Fludeoxyglucose (18F) is also accumulated by the myocardium, especially during and after a reversible myocardial ischemia when an increased glucose uptake occurs into the myocardial cell.
Maltese: Fludeoxyglucose (18F) jinġema' wkoll permezz tal-mijokardju, l-aktar waqt u wara iskimja mijokardjali riversibbli meta sseħħ żieda fl-użu tal-glucose fiċ-ċellola mijokardjali.
English: Gluscan is a radiopharmaceutical medicinal product composed of fludeoxyglucose (18F), abbreviated as FDG.
Maltese: Rigward l-effikaċja dijanjostika ta' fludeoxyglucose (18F) f'pazjenti b'defiċjenza immunitarja, l
English: The CHMP therefore agreed that the paediatric population aged less than 18 years should be included in the SmPC.
Maltese: Għalhekk, is-CHMP qabel li l-popolazzjoni pedjatrika li għandha inqas minn 18-il sena għandha tkun inkluża fl-SmPC.
English: 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.
Maltese: Id-dejta dwar is-sigurtà għat-teknoloġija kkombinata PET/CT mhix differenti minn dik tal-PET; lunika differenza tkun żieda fid-doża ta' radjazzjoni, minħabba d-doża baxxa ta' CT, li ma tipproduċi lebda konsegwenza li tista' tiġi osservata.
English: France
Maltese: FRANZA
English: For patients under specific concomitant medications such as antibiotics and anti-inflammatory drugs, common sense indicates that in the corresponding claimed settings in long lasting or chronic illness (fever of unknown origin (FUO), chronic infection of bone, suspicion of infected hip prosthesis, active inflammatory bowel disease (IBD) …), they were not effective since the patient was referred to FDG PET.
Maltese: Għall-pazjenti taħt kuri konkomittanti bħalma huma antibijotiċi u pilloli ta' kontra l-infjammazzjoni, is-sens komun jindika li fl-isfondi ddikjarati korrispondenti f'mard li jdum ħafna żmien jew f'mard kroniku (deni minn oriġini mhux magħrufa (FUO), infezzjoni kronika tal-għadam, suspett ta' infezzjoni tal-proteżi tal-ġenb, mard infjammatorju attiv tal-imsaren (IBD) …), ma kinux effettivi minħabba li l-pazjent ġie riferut għal FDG PET. Minħabba li l-FDG PET jiddijanjostika b'mod preċiż dawk il-kundizzjonijiet, l-interferenza ta' dawk il-kuri inevitabbli żgur li titqies bħala waħda minuri.
English: Corticosteroids have been shown to decrease profoundly or suppress FDG uptake.
Maltese: Il-kortikosterojdi nstabu li jnaqqsu ħafna jew irażżnu t-teħid tal-FDG.
English: - 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)
Maltese: - ingħatat kunsiderazzjoni sodisfaċenti lil sitwazzjonijiet bħalma huma pazjenti b'immunodefiċjenza, b'disfunzjoni tal-lewkoċite u pazjenti taħt kuri konkomittanti speċifiċi li jaffettwaw il-vijabbiltà u/jew il-funzjoni tal-lewkoċiti (bħalma huma antibijotiċi, mediċini ta' kontra l-infjammazzjoni li mhumiex sterojdi, eċċ)
English: 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.
Maltese: Il-prestazzjoni teknika - is-superjorità tal-FDG fuq il-komparaturi radjufarmaċewtiċi kollha ġiet iddokumentata f'artikli, u hija applikabbli għall-isfondi proposti kollha ta' dawn l-indikazzjonijiet.
English: It would seem to be detrimental and against the Euratom Directives (optimisation of irradiation) to exclude children from the benefit of FDG PET in infection and inflammation (in particular FUO or IBD), since some other scintigraphic options (gallium-67 scintigraphy, indium-111 WBC scintigraphy) are actually more irradiating and/or more demanding and would lead to the management of children in a less convenient way than adults.
Maltese: FUO jew IBD), minħabba li xi (sintigrafija gallium-67, sintgrafija tal-WBC indium-111) opzjonijiet sintigrafiċi oħrajn huma fil-fatt aktar irradjanti u/jew aktar eżiġenti u jwasslu għall-immaniġġjar tat-tfal b'mod inqas konvenjenti milli filkaż tal-adulti.
English: Although PPV was favourable, and impact on management was available, according to the PtC, it was agreed during previous discussions with the RMS, CMS and Applicant, that this important information would remain in section 4.4 of the SmPC as its inclusion would be of value for the prescription and interpretation of FDG-PET in this indication.
Maltese: Għalkemm il-PPV kien favorevoli, u l-impatt fuq l-immaniġġjar kien disponibbli, skont il-PtC, kien hemm qbil waqt diskussjonijiet preċedenti mal-RMS, is-CMS u l-Applikant, li dan it-tagħrif importanti għandu jibqa' f'sezzjoni 4.4 tal-SmPC minħabba li l-inklużjoni tiegħu tkun ta' siwi għallpreskrizzjoni u l-interpretazzjoni ta' FDG-PET f'din l-indikazzjoni.
English: 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.
Maltese: Minħabba li l-protezzjoni mir-radjazzjoni hija parti mis-sigurtà, huwa nnutat ukoll li, minkejja li rradjufarmaċewtiċi dijanjostiċi rreġistrati kollha huma ġeneralment siguri, l-FDG huwa maħsub li huwa wieħed mill-aktar siguri, u ħafna inqas irradjanti minn gallium-67 jew indium-111.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION PRESENTED BY THE EMEA
Maltese: ANNESS II KONKLUŻJONIJIET XJENTIFIĊI
English: Intravenous use For 1mL of drug product: Fludeoxyglucose (18F) - 500MBq at calibration time,
Maltese: Għal 1mL tal-prodott mediċinali: Fludeoxyglukosju (18F) - 500MBq f'ħin ta' kalibrazzjoni, Ilma għal injezzjoni - 1.00g, Ċitrat tas-sodju - 0.62% (v/v), Klorur tas-sodju - 0.
English: 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.
Maltese: Il-partikolarità tal-applikazzjoni preżenti hija li l-indikazzjoni proposta fil-mard infettiv u infjammatorju fil-preżent ma tagħmilx parti mill-SPC ċentrali għal FDG.
English: The use of FDG PET-CT has been reported in all of the 10 proposed indications in ‘Infectious or inflammatory diseases', except for the detection of infection of hip prostheses, at this point in time.
Maltese: L-użu ta' FDG PET-CT ġie rrappurtat fl-10 indikazzjonijiet proposti kollha f'‘Mard infettiv jew infjammatorju', ħlief għall-iskoperta ta' infezzjoni tal-proteżi tal-ġenb, f'dan il-punt ta' żmien.
English: 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.
Maltese: Wieħed għandu jżomm f'moħħu li l-effetti farmakodinamiċi ta' dawn il-mediċini (eż. kortikosterojdi) fuq lewkoċiti li qegħdin jieħdu l-FDG huma identiċi fl-isfondi kollha, u li mhemmx ħtieġa ta' wiri sfond, sfond tal-interferenza, anki jekk il-konsegwenza fuq il-ħsib dijanjostiku jista' jkun differenti minn sfond għal ieħor.
English: 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.
Maltese: Gluscan huwa maħsub sabiex jintuża fl-indikazzjonijiet onkoloġiċi, kardjoloġiċi u newroloġiċi u mard infettiv jew infjammatorju.
English: 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.
Maltese: Kull waħda minn dawn l-indikazzjonijiet kienet ibbażata fuq proċess bijoloġiku, jiġifieri t-teħid tal-glucose minn organi jew tessuti speċifiċi: żieda fitteħid miċ-ċelloli malinni, teħid persistenti miċ-ċelloli mijokardjali pperikolati vijabbli u tnaqqis fitteħid min-newroni tal-kortiċi responsabbli għall-promozzjoni ta' epilessija meta pazjent ma jkunx qed jippreżenta kriżi.