natgillin/translations-raw huggingface dataset:
- 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.
- 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
- dokazi o okužbah in vnetnih boleznih, ki so obravnavani pri vrednotenju te dokumentacije za dobro uveljavljeno uporabo, predstavljajo natančno izbrane študije po kriterijih dokumenta „Vidiki, ki jih je treba upoštevati“ pri vrednotenju diagnostičnih zdravil (CPMP/EWP/1119/98) ter le najbolje opisane klinične okoliščine
There is no impact on the SmPC at the moment since it has not been demonstrated that any of the settings of this indication significantly benefit from PET/CT fusion as compared to PET alone.
Trenutno ni vpliva na povzetek glavnih značilnosti zdravila, saj ni bilo dokazano, da je v kateri koli od teh indikacij kombinacija PET/CT bistveno koristnejša od preiskave samo s PET.
- the technical performance has been documented in articles, and is applicable to all the proposed infectious or inflammatory diseases
- tehnična zmogljivost je opisana v virih in se nanaša na vse predlagane okužbe ali vnetne bolezni
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.
Čeprav je sporno, da je učinkoviti odmerek sevanja iz spojin, označenih s 99mTc, podoben kot pri FDG, je najenostavnejša uporaba primerjalnega zdravila, označenega s 99mTc, tj. imunoscintigrafija, kontraindicirana pri otrocih zaradi dobro dokumentiranega vzroka, tj. pojava protiteles, ki preprečijo kasnejšo uporabo.
The total effective dose of FDG PET/CT with a low dose CT is less than that of a full contrast enhanced diagnostic CT of the same area.
V istem področju je skupni učinkoviti odmerek preiskave PET/CT s FDG in nizkoodmernim CT manjši od polnokontrastne izboljšane diagnostične preiskave CT.
The three indications oncology, cardiology and neurology are established in the core SmPC for this active substance.
Tri indikacije (onkologija, kardiologija in nevrologija) so določene v temeljnem povzetku glavnih značilnosti zdravila za to zdravilno učinkovino.
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.
Uporaba PET-CT s FDG je bila do danes opisana za vseh 10 predlaganih indikacij „okužb ali vnetnih bolezni“, razen za odkrivanje okužb umetnih kolkov.
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.
Ugotovljeno je bilo, da: je lastna ločljivost tomografa z emisijo pozitronov dvakrat boljša od kamere gama z nizkoenergijskim kolimatorjem za tehnecij-99m in več kot dvakrat boljša od srednjeenergijskega kolimatorja za galij-67 ali indij-111, je čakalna doba za bolnika (1 ura od injiciranja do zajema slike) najkrajša med vsemi registriranimi radiofarmaki, ki se uporabljajo na tem področju, so druge neprijetnosti/tveganja za bolnika manj pomembna kot pri galiju-67 (neudobna priprava bolnika) ali označenih levkocitih, kjer je potreben odvzem velike količine krvi in se možna tveganja napake pri ponovnem injiciranju, je dozimetrija preiskave PET s FDG podobna kot pri zdravilih, označenih s tehnecijem-99m, ter boljša kot pri radiofarmakih z galijem-67 ali indijem-111.
Fludeoxyglucose (18F) passes the blood-brain barrier, and epileptogenic foci exhibit a reduced glucose metabolism in the seizure free phases.
Fludeoksiglukoza (18F) prehaja možgansko-krvno bariero, epileptogena žarišča pa kažejo zmanjšano presnovo glukoze v fazah brez napadov.
The issue was referred to the CMD(h) and an assessment was carried out by the RMS.
Vprašanje je bilo posredovano usklajevalni skupini za postopek medsebojnega priznavanja in decentralizirani postopek v humani medicini CMD(h) in referenčna država članica je izvedla vrednotenje.
- a high impact on patient management has been reported for the overall indication and for every infectious or inflammatory diseases
- poročajo o visokem vplivu na obravnavo bolnika za skupno indikacijo in za vse posamezne okužbe ali vnetne bolezni
In conclusion the CHMP considers that the benefit-risk profile is favourable for Gluscan (FDG) in the indication ‘infectious or inflammatory diseases' addressed above.
V zaključku CHMP meni, da je razmerje med koristmi in tveganjem ob uporabi zdravila Gluscan (FDG) za zgoraj obravnavano indikacijo „okužbe in vnetne bolezni“ ugodno.
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.
Fludeoksiglukoza (18F) se kopiči tudi v miokardu, zlasti med reverzibilno miokardno ishemijo in po njej, saj se takrat poveča privzem glukoze v celice tega tkiva.
The impact on management was as obvious as in adults (FUO, IBD) and even more striking in the case of granulomatosis (Güngör 2001).
Vpliv na obravnavo bolnika je bil jasen kot pri odraslih (zvišana telesna temperatura neznanega vzroka, aktivna vnetna bolezen črevesja) ter še izrazitejši pri granulomatozi (Güngör 2001).
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.
Pri bolnikih s specifičnimi sočasno uporabljenimi zdravili, kot so antibiotiki in protivnetna zdravila, je jasno, da v ustreznih okoliščinah, ki so obravnavane v vlogi, z dolgotrajno ali kronično boleznijo (zvišana telesna temperatura neznanega vzroka, kronična okužba kosti, sum okužbe umetnega kolka, aktivna vnetna bolezen črevesja ...) niso bila učinkovita, saj so bolnike napotili na PET s FDG.
There is no reason to anticipate a lower efficacy in children as compared to adults for a diagnostic examination that is useful in a large spectrum of causes, which are both found in children and adults, without any metabolic specificity in children.
Pri diagnostični preiskavi, ki je uporabna za širok razpon vzrokov, ki jih odkrivamo pri otrocih in odraslih brez vsake presnovne specifičnosti za otroke, ni razloga za pričakovanje manjše učinkovitosti pri otrocih v primerjavi z odraslimi.
Furthermore for all the requested infectious and inflammatory diseases, the diagnostic performance has been determined and found to be at least equal to that of the comparator, when the studies of the same disease have been pooled together.
Poleg tega so bile za vse zadevne okužbe in vnetne bolezni določene diagnostične zmogljivosti, ob združenju študij enakih bolezni, pa je bilo ugotovljeno tudi, da so te zmogljivosti enakovredne najmanj primerjalnemu zdravilu.
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.
Kljub ugodni pozitivni napovedni vrednosti in jasnemu vplivu na obravnavo bolnika v dokumentu „Vidiki, ki jih je treba upoštevati“, so se referenčna država članica, zadevne države članice in predlagatelj v prejšnjih razpravah dogovorili, da ta pomemben podatek ostane v poglavju 4.4 povzetka glavnih značilnosti zdravila, saj bi njegova vključitev lahko pomagala pri predpisovanju in interpretaciji PET s FDG za to indikacijo.
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).
V objavljenih nizih (brez poročil o primerih) je navedeno skupno 6 125 bolnikov s celega sveta, ki so do danes opravili pozitronsko emisijsko tomografijo (PET) s FDG, indicirano zaradi vnetja in okužbe (brez naključnih odkritij okužbe/vnetja pri bolnikih, ki so bili napoteni zaradi druge indikacije).
This has been demonstrated for some settings in oncology and is reported in the Core SmPC, but is not currently the case in infection/inflammation.
To je bilo dokazano za nekatere okoliščine v onkologiji (kar je opisano v temeljnem povzetku glavnih značilnosti zdravila) ne pa pri okužbah/vnetjih.
As with the other indications in the core SmPC, the indication in infectious or inflammatory diseases is also based on a biological process: glucose uptake in tissue or structures with an abnormal content of activated white blood cells.
Tudi indikacija okužb oz. vnetnih bolezni kot pri drugih indikacijah v temeljnem povzetku glavnih značilnosti zdravila temelji na biološkem procesu: privzemu glukoze v tkivu ali strukturi z nenormalno vsebnostjo aktiviranih levkocitov.
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.
Pregledali so kartoteke 248 bolnikov z multiplim mielomom, pri katerih je preiskava PET s FDG odkrila povečan privzem radioaktivnega označevalca izven kostnega mozga in/ali lezij v kosteh in sklepih (ki so atipične za multipli mielom), in odkrili primere okužb.
at calibration time, 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) Sodium hydroxide 0.24% (v/v)
Za 1 mL zdravila: fludeoksiglukoza (18 F) - 500 MBq v času kalibracije, voda za injiciranje - 1,00 g, natrijev citrat - 0,62 % (v/v), natrijev klorid - 0,41 % (v/v), klorovodikova kislina - 0,39 % (v/v), etanol 0,31 % (v/v), natrijev hidroksid - 0,24 % (v/v),
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.
Kot je navedeno, bi bilo prikrajšanje otrok z okužbami/vnetji za koristne učinke PET s FDG v nasprotju z načelom optimizacije direktive Euratom (uveljavljenje v zakonodaji vseh držav članic EU), saj so pri nekaterih drugih scintigrafskih možnostih otroci (scintigrafija z galijem-67, scintigrafija z levkociti, označenimi z indijem-111) ali osebje (označevanje s tehnecijem-99m HMPAO in vitro) bolj izpostavljeni sevanju, ne da bi se učinkovitost povečala.
It is also true that a careful weighting of the indication is requested in the SmPC for any paediatric use.
Ravno tako velja, da se v povzetku glavnih značilnosti zdravila za vsako uporabo pri otrocih zahteva natančen razmislek o indikaciji.
This is already reported in the Core SmPC.
To je že navedeno v temeljnem povzetku glavnih značilnosti zdravila.
Fludeoxyglucose (18F) is accumulated in tumours with a high glucose turnover.
Fludeoksiglukoza (18F) se kopiči v tumorjih z velikim pretvarjanjem glukoze.
PET/CT is now the state-of-the-art for FDG detection and it is clear from literature and expert opinion that it cannot deteriorate technical and diagnostic performances when compared to PET alone.
- preiskava PET/CT omogoča trenutno najsodobnejše zaznavanje FDG in ne kaže manjše tehnične in diagnostične zmogljivosti v primerjavi s samo PET
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)
natrijev klorid - 0,41 % (v/v), klorovodikova kislina - 0,39 % (v/v), etanol 0,31 % (v/v), natrijev hidroksid - 0,24 % (v/v),
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.
Prikrajšanje otrok z okužbo in vnetjem (zlasti zvišano telesno temperaturo neznanega vzroka, aktivno vnetno boleznijo črevesja) za koristne učinke PET s FDG se zdi škodljivo in v nasprotju z direktivami Euratom (optimizacija sevanja), saj sta pri nekaterih drugih scintigrafskih možnostih (scintigrafija z galijem-67, scintigrafija z levkociti, označenimi z indijem111) izpostavljenost sevanju in/ali zahtevnost večji, kar bi povzročilo, da je zdravljenje otrok manj primerno kot zdravljenje odraslih.
However, a number of concerns were raised by the objecting CMS which did not consider the application for Gluscan acceptable.
Vendar nekatere zadevne države članice vloge za zdravilo Gluscan niso štele za sprejemljivo in so nasprotovale z več zadržki.
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.
Odmerjanje (tj. injiciranje), ki je priporočeno v temeljnem povzetku glavnih značilnosti zdravila (100−400 MBq s prilagoditvijo za otroke), je skladno z aktivnostmi, ki so bile uporabljene v objavljenih kliničnih študijah za okužbe/vnetja ne glede na uporabljeni aparat (PET, CDET ali PETCT).
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.
CHMP je zato potrdil odstavek, ki ga je predlagala zadevna država članica v poglavju 4.5 povzetka glavnih značilnosti zdravila (Medsebojno delovanje z drugimi zdravili in druge oblike interakcij), ki opozarja na učinek kortikosteroidov na privzem FDG v okviru indikacije okužbe in vnetja ter poziva k proučitvi začasne prekinitve tega zdravljenja.
- PET-CT is now the state-of-the-art for FDG detection and does not show a deterioration in technical and diagnostic performances when compared to PET alone the CHMP has recommended the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for GLUSCAN 500 and associated names (see Annex I).
CHMP je priporočil, da se za zdravilo, katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostanejo enaki zadnjim različicam, pripravljenim v postopku usklajevalne skupine (glejte Dodatek III) za zdravilo GLUSCAN 500 in povezana imena (glejte Dodatek I), odobri dovoljenje za promet.
Intravenous use For 1mL of drug product: Fludeoxyglucose (18F) - 500MBq at calibration time,
Za 1 mL zdravila: fludeoksiglukoza (18 F) - 500 MBq v času kalibracije, voda za injiciranje - 1,00 g, natrijev citrat - 0,62 % (v/v),
Portugal
Portugals ka
27 June 2013
27. junij 2013
Outcome of procedures under Article 20 of Regulation (EC) No 726/2004 and Article 31 of Directive 2001/83/EC
Izid postopkov v skladu s členom 20 Uredbe (ES) št. 726/2004 in členom 31 Direktive 2001/83/ES
The CHMP also considered available guidance from the World Health Organization.
CHMP je preučil tudi razpoložljive smernice Svetovne zdravstvene organizacije.
However, the evidence, including the follow-up of some of the cases, was not sufficient to allow the Committee to be certain there was no association.
Vendar dokazi, vključno s sledenjem nekaterim primerom, niso bili zadostni, da bi odbor lahko z gotovostjo sklenil, da ni nobene povezave.
(This does not apply to Zostavax, which has different strength and indications.)
(To pa ne velja za cepivo Zostavax, ki ima drugačno jakost in indikacije.)
The product information should be updated to reflect these changes.
Informacije o zdravilu je treba posodobiti tako, da bodo vključevale te spremembe.
Vax, Rouvax, Trivivac, Varilrix, Varivax, and associated names.
Vax, Rouvax, Trivivac, Varilrix, Varivax in povezanimi imeni.