FrancophonIA/ELRC3.0 huggingface dataset:
English: Norfloxacine Mylan Norfloxacin 400mg Tablet
Maltese: Norfloxacine Mylan Pillola ta' Norfloxacin 400mg Pillola miksija b'rita Użu Orali
English: Linear GdCAs products
Maltese: Prodotti GdCAs lineari
English: Clinical data
Maltese: Data klinika
English: Higher relaxivity of Multihance
Maltese: Relassavità ogħla ta' Multihance
English: In accordance with Article 107k of Directive 2001/83/EC, the CHMP considered the PRAC recommendation adopted on 6 July 2017.
Maltese: Skont l-Artikolu 107k tad-Direttiva 2001/83/KE, is-CHMP ikkunsidra r-rakkomandazzjoni tal-PRAC li ġiet adottata fis-6 ta' Lulju 2017.
English: Intravenous linear Gadolinium-containing contrast agents (GdCAs)
Maltese: Aġenti ta' kuntrast li fihom Gadolinium (GdCAs, Gadolinium-containing contrast agents) lineari ġol-vini
English: • To complement the information in the SmPC with evidence-based educational programs;
Maltese: • Sabiex tiġi kkumplimentata l-informazzjoni fl-SmPC bi programmi edukattivi bbażati fuq l-evidenza;
English: The PRAC also noted that high GdCAs doses were tested (20x2.5 mmol) by McDonald et al., and the study duration is comparably short (e.g. the total doses tested in Frenzel et al 2017 was half that of McDonald et al (10x2.5mmol), while the time period to the last tissue sampling in Frenzel et al 2017 was 24 days instead of 7 days in McDonald 2017.)
Maltese: Il-PRAC innota wkoll li ġew ittestjati dożi għoljin ta' GdCAs (20x2.5 mmol) minn McDonald et al., u ddurata tal-istudju hija relattivament qasira (eż. id-doża totali ttestjati fi Frenzel et al 2017 kienet nofs dik ta' McDonald et al (10x2.5 mmol), filwaqt li l-perjodu ta' żmien għall-aħħar kampjunar tat-tessut fi Frenzel et al 2017 kien 24 jum minflok 7 ijiem f'McDonald 2017.)
English: Organ-specific indication for Omniscan
Maltese: Indikazzjoni speċifika għall-organu għal Omniscan
English: Intra-articular GdCA products
Maltese: Prodotti GdCA intraartikulari
English: PRAC also considered the two linear GdCAs, gadoxetic acid (Primovist) and gadobenic acid (Multihance).
Maltese: Il-PRAC ikkunsidra wkoll ż-żewġ GdCAs lineari, gadoxetic acid (Primovist) u gadobenic acid (Multihance).
English: All GdCAs have some degree of renal elimination, which varies from 50% for gadoxetic acid to 100% for most other members of the class.
Maltese: Il-GdCAs kollha għandhom xi grad ta' eliminazzjoni mill-kliewi, li jvarja minn 50 % għal gadoxetic acid sa 100 % għall-ħafna mill-membri l-oħra tal-klassi.
English: • CHMP considered options for risk minimisation measures.
Maltese: • Is-CHMP ikkunsidra opzjonijiet għall-miżuri tal-minimizzazzjoni tar-riskju.
English: The absolute rate of hypersensitivity reactions with GdCAs is low and reported as approximately 0.01% to 0.001% across the studies investigating rates of hypersensitivity reactions.
Maltese: Ir-rata assoluta ta' reazzjonijiet ta' sensittività eċċessiva bil-GdCAs hija baxxa u rrappurtata bħala madwar 0.01 % sa 0.001 % fl-istudji li jinvestigaw ir-rati ta' reazzjonijiet ta' sensittività eċċessiva.
English: Population-specific indication for Multihance
Maltese: Indikazzjoni speċifika għall-popolazzjoni għal Multihance
English: • variation to the terms of the marketing authorisation for the intraarticular linear agent gadopentetic acid (Magnevist), and the intravenous linear agents gadoxetic acid (Primovist) and gadobenic acid (Multihance) with changes to SmPC sections 4.1, 4.2, 4.4 and 5.2, including removal of indications,
Maltese: • varjazzjoni għat-termini tal-awtorizzazzjoni għat-tqegħid fis-suq għall-aġent lineari intraartikulari gadopentetic acid (Magnevist), u l-aġenti lineari ġol-vini gadoxetic acid (Primovist) u gadobenic acid (Multihance) b'tibdil fis-sezzjonijiet tal-SmPC 4.1, 4.2, 4.4 u 5.2, inkluż it-tneħħija talindikazzjonijiet,
English: The PRAC considered all the available data related to the safety and efficacy to the medicinal products containing gadodiamide, gadopentetic acid, gadobenic acid, gadoxetic acid, gadoteridol, gadobutrol, gadoteric acid and gadoversetamide within the procedure under Article 31 of Directive 2001/83/EC.
Maltese: Il-PRAC ikkunsidra d-data disponibbli kollha relatata mas-sigurtà u l-effikaċja tal-prodotti mediċinali li fihom gadodiamide, gadopentetic acid, gadobenic acid, gadoxetic acid, gadoteridol, gadobutrol, gadoteric acid u gadoversetamide fil-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: Following the adoption of the PRAC recommendation during the March 2017 PRAC meeting, two MAHs (Bracco and GE Healthcare) expressed their disagreement with the initial PRAC recommendation.
Maltese: Wara l-adozzjoni tar-rakkomandazzjoni tal-PRAC matul il-laqgħa tal-PRAC ta' Marzu 2017, żewġ MAHs (Bracco u GE Healthcare) esprimew in-nuqqas ta' qbil tagħhom mar-rakkomandazzjoni inizjali talPRAC.
English: Gadolinium containing contrast agents (GdCAs) are complexes of paramagnetic gadolinium (III) with different types of organic chelators.
Maltese: Aġenti ta' kuntrast li fihom gadolinium (GdCAs, gadolinium containing contrast agents) huma kumplessi ta' gadolinium (III) paramanjetiku b'tipi differenti ta' kelaturi organiċi.
English: With regards to non-clinical studies, unchelated gadolinium in the form of gadolinium chloride has been shown to be toxic with effects including cellular necrosis, fibrosis, and lesions related to mineral deposition (Spencer et al. 1997; Rees et al. 1997), and an in vitro study in rat neurons reported gadolinium-induced cytotoxicity via oxidative injury (Xia et al. 2011).
Maltese: Fir-rigward ta' studji mhux kliniċi, gadolinium mhux kelatat fil-forma ta' gadolinium chloride intwera li huwa tossiku b'effetti li jinkludu nekrożi ċellulari, fibrożi u leżjonijiet relatati mad-depożitu tal-minerali (Spencer et al. 1997; Rees et al. 1997), u studju in vitro fin-newroni tal-firien irrapporta ċitotossiċità indotta minn gadolinium permezz ta' ħsara ossidattiva (Xia et al. 2011).
English: In non-clinical studies (Robert et al. 2016 Lohrke et al. 2015; Lohrke et al. 2016; Kartamihardja et al. 2016a; Kartamihardja et al. 2016b; Smith et al. 2017; Rasschaert et al. 2016; MAH unpublished studies) the levels were typically around 10-fold higher with linear agents.
Maltese: Kartamihardja et al. 2016b; Smith et al. 2017;
English: Data from the clinical post-mortem studies are heterogeneous and it is therefore difficult to compare the levels.
Maltese: Data minn studji post-mortem kliniċi kienu eteroġeni u għalhekk huwa diffiċli li jitqabblu l-livelli.
English: These areas are involved in the regulation of voluntary and involuntary movement; adverse events could potentially include events such as ataxia, tremors and other movement disorders.
Maltese: Dawn il-partijiet huma involuti fir-regolazzjoni ta' moviment volontarju u involontarju; lavvenimenti avversi jistgħu potenzjalment jinkludu avvenimenti bħal atassija, rogħda u disturbi tal moviment oħra.
English: Toxicity of non-chelated gadolinium
Maltese: Tossiċità ta' gadolinium mhux kelatat
English: GdCAs can be differentiated by their structure: linear (gadodiamide, gadopentetic acid, gadobenic acid, gadoxetic acid, gadoversetamide) or macrocyclic (gadoteridol, gadobutrol, gadoteric acid), and by the overall charge on the complex formed (ionic or non-ionic).
Maltese: Il-GdCAs jista' jiġu differenzjati millistruttura tagħhom: lineari (gadodiamide, gadopentetic acid, gadobenic acid, gadoxetic acid, gadoversetamide) jew makroċiklika (gadoteridol, gadobutrol, gadoteric acid), u miċ-ċarġ globali fuq ilkumpless iffurmat (jonika jew mhux jonika).
English: • The shape and size of the T1 signal is markedly different from the signal shape reported in two other recent publications, (Jost et al., 2016, and Robert et al., 2015) and it is not fully clear whether the region of enhanced signal indeed corresponds to the DN, or other regions in the brain.
Maltese: • Il-forma u d-daqs tas-sinjal T1 huwa notevolment differenti mill-forma tas-sinjal irrappurtata f'żewġ pubblikazzjonijiet riċenti oħra, (Jost et al., 2016, u Robert et al., 2015) u mhuwiex ċar għalkollox jekk ir-reġjun tas-sinjal imtejjeb tabilħaqq jikkorrispondix mad-DN, jew ma' reġjuni oħra fil-moħħ.
English: Toxicity has been seen in other tissues where it accumulates (including NSF, skin plaques) and in non-clinical data.
Maltese: It-tossiċità dehret f'tessuti oħra fejn takkumula (inkluż NSF, plakek talġilda) u f'data mhux klinika.
English: Skin prick testing could facilitate the identification of an alternative GdCA.
Maltese: L-ittestjar permezz ta' tingiż tal-ġilda jista' jiffaċilita l-identifikazzjoni ta' GdCA alternattiv.
English: The CHMP concluded that the risk of NSF is different for the different gadolinium-containing contrast agents, which lead to the categorisation of GdCAs into three risk groups for NSF (high risk, medium risk and low risk).
Maltese: Is-CHMP ikkonkluda li r-riskju ta' NSF huwa differenti għall-aġenti ta' kuntrast differenti li fihom gadolinium, li jwassal għall-kategorizzazzjoni tal-GdCAs fi tliet gruppi ta' riskju għal NSF (riskju għoli, riskju medju u riskju baxx).
English: In a previous referral under Article 31 of Directive 20010/83/EC finalised in 2010, the Committee for Medicinal Products for Human Use (CHMP) concluded that the use of GdCAs was associated with the risk of nephrogenic systemic fibrosis (NSF), a serious and life-threatening syndrome involving fibrosis of the skin, joints and internal organs in patients with renal impairment.
Maltese: F'referenza preċedenti skont l-Artikolu 31 tad-Direttiva 2010/83/KE ffinalizzata fl-2010, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li l-użu tal-GdCAs kien assoċjat mar-riskju ta' fibrożi sistemika nefroġenika (NSF, nephrogenic systemic fibrosis), sindrome serju u ta' periklu għall-ħajja li jinvolvi fibrożi tal-ġilda, tal-ġogi u tal-organi interni f'pazjenti b'indeboliment talkliewi.
English: Final benefit-risk balance
Maltese: Bilanċ finali bejn il-benefiċċju u r-riskju
English: • variation to the terms of the marketing authorisation for the macrocyclic agents (gadoteridol (Prohance), gadobutrol (Gadovist), gadoteric acid (Dotarem and Artirem)) with changes to SmPC sections 4.1 and 4.2.
Maltese: • varjazzjoni għat-termini tal-awtorizzazzjoni għat-tqegħid fis-suq għall-aġenti makroċikliċi (gadoteridol (Prohance), gadobutrol (Gadovist), gadoteric acid (Dotarem and Artirem)) b'tibdil fissezzjonijiet tal-SmPC 4.1 u 4.2.
English: This dissociation is believed to be related to differences in the stability of the complexes among the various types of GdCAs (Spencer et al. 1997).
Maltese: Din id-dissoċjazzjoni hija maħsuba li hija relatata mad-differenzi fl-istabbiltà tal-kumplessi fost iddiversi tipi ta' GdCAs (Spencer et al. 1997).
English: Lanthanide ions such as gadolinium can bind to Ca2+ binding enzymes and interfere with calcium channels, due to competition with Ca2+ in cellular and biochemical processes, which can lead to adverse biological effects (Sherry et al. 2009).
Maltese: Joni ta' lanthanide bħal gadolinium jistgħu jorbtu ma' enzimi li jorbtu ta' Ca2+ u jinterferixxu ma' kanali tal-kalċju, minħabba kompetizzjoni ma' Ca2+ fi proċessi ċellulari u bijokimiċi, li tista' twassal għal effetti bjioloġiċi avversi (Sherry et al. 2009).
English: Gadolinium containing products have been stratified by risk category for NSF, and warnings and restrictions on the use of the higher NSF risk products in patients with impaired renal function are included in the product information, including contraindication of the high NSF risk products in patients with severe renal impairment or acute kidney injury (AKI) and a switch to the use of low risk products.
Maltese: Prodotti li fihom gadolinium ġew stratifikati permezz ta' kategorija tar-riskju għal NSF, u twissijiet u restrizzjonijiet dwar l-użu ta' prodotti b'riskju ogħla ta' NSF f'pazjenti b'funzjoni tal-kliewi indebolita huma inklużi fl-informazzjoni dwar il-prodott, inkluż kontraindikazzjoni tal-prodotti b'riskju għoli ta' NSF f'pazjenti b'indeboliment tal-kliewi sever jew bi ħsara akuta fil-kliewi (AKI, acute kidney injury) u qlib għall-użu ta' prodotti b'riskju baxx.
English: For gadobenic acid, the available studies do not establish differences in relaxivity, image quality and technical performance.
Maltese: Għal gadobenic acid, l-istudji disponibbli ma jistabbilixxux differenzi fir-relassavità, fil-kwalità talimmaġni u fil-prestazzjoni teknika.
English: • the study results from the Mayo Clinic Study of Ageing (MCSA) study (McDonald et al. 2017, manuscript in preparation), are limited by small sample sizes, relatively short follow-up with regard to potential long-term effects, lack of discussion of sensitivity of the envisaged endpoints regarding detection of potential adverse effects, lack of full detailed information on statistical methods and their robustness and that they are overall too limited to provide reassurance about the safety of usage of GdCAs.
Maltese: • ir-riżultati tal-istudju mill-istudju L-Istudju dwar ix-Xjuħija ta' Mayo Clinic (MCSA, Mayo Clinic Study of Ageing) (McDonald et al. 2017, il-manuskritt qed jitħejja), huma limitati minn daqsijiet ta' kampjuni żgħar, segwitu relattivament qasir fir-rigward tal-effetti fit-tul potenzjali, nuqqas ta' diskussjoni dwar is-sensittività tal-end-points previsti rigward l-identifikazzjoni ta' effetti avversi potenzjali, nuqqas ta' informazzjoni dettaljata sħiħa dwar il-metodi statistiċi u r-robustezza tagħhom u li globalment huma wisq limitati biex jipprovdu riassigurazzjoni dwar is-sigurtà tal-użu tal-GdCAs.
English: Particularly zinc, copper and iron (Frenzel et al., 2008) are described as competing metals which can liberate Gd; glycosaminoglycans like heparin may bind Gd and thereby remove it from its pharmacological chelator.
Maltese: B'mod partikolari, iż-żingu, ir-ram u l-ħadid (Frenzel et al., 2008) huma deskritti bħala metalli ta' kompetizzjoni li jistgħu jilliberaw Gd; glycosaminoglycans bħal heparin jistgħu jorbtu Gd u b' hekk ineħħuh mill-kelatur farmakoloġiku tiegħu.
English: Linear GdCAs are associated with a significant risk of NSF.
Maltese: Il-GdCAs lineari huma assoċjati ma' riskju kbir ta' NSF.
English: A number of studies have shown a correlation between the number of exposures to linear GdCAs and the signal intensity changes.
Maltese: Numru ta' studji wrew korrelazzjoni bejn in-numru ta' esponimenti għal GdCAs lineari u t-tibdil fl-intensità tas-sinjal.
English: Indeed, PRAC considered the results of two intra-individual, crossover comparisons of 0.1 mmol/kg body weight with Multihance vs 0.1 mmol/kg body weight of two active comparators (gadopentetate dimeglumine and gadodiamide), in patients with known or suspected brain or spine disease undergoing MRI of the central nervous system (CNS) (MH-109, MH-130) and concluded that the studies were using a blinded comparison of MRI images obtained with two GdCAs side by side and have produced results favouring Multihance on the basis of brighter appearance of the images, but not reflecting any difference in the diagnostic information available or the impact on diagnostic thinking, patient management or clinical outcome.
Maltese: Tabilħaqq, il-PRAC ikkunsidra r-riżultati ta' żewġ tqabbiliet intraindividwali inkroċjati ta' 0.1 mmol/kg piż tal-ġisem b'Multihance kontra 0.1 mmol/kg piż tal-ġisem ta' żewġ kumparaturi attivi (gadopentetate dimeglumine u gadodiamide), f'pazjenti b'marda tal-moħħ jew tas-sinsla tad-dahar magħrufa jew suspettata li kienu għaddejjin minn MRI tas-sistema nervuża ċentrali (CNS) (MH-109, MH-130) u kkonkluda li l-istudji kienu qed jużaw tqabbil "blinded" tal-immaġnijiet tal-MRI miksubin minn żewġ GdCAs ħdejn xulxin u pproduċew riżultati li jiffavorixxu lil Multihance abbażi ta' dehra aktar ċara tal-immaġnijiet, iżda li ma jirriflettux xi differenza fl-informazzjoni dijanjostika disponibbli jew flimpatt fuq il-ħsieb dijanjostiku, fl-immaniġġjar tal-pazjent jew fir-riżultat kliniku.
English: Non-clinical evidence also shows potential for release of gadolinium from the chelating ligand in the brain with linear GdCAs, but not with macrocyclic GdCAs (Frenzel et al. 2017).
Maltese: Evidenza mhux klinika turi wkoll potenzjal għal rilaxx ta' gadolinium milligand kelanti fil-moħħ b'GdCAs lineari, iżda mhux b'GdCAs makroċikliċi (Frenzel et al. 2017).
English: This was discussed with clinical experts within an ad hoc expert group meeting that confirmed a possible association but this has not yet been demonstrated.
Maltese: Dan ġie diskuss ma' esperti kliniċi f'laqgħa ta' grupp ta' esperti ad hoc li kkonfermat assoċjazzjoni possibbli iżda din għadha ma ntweritx.
English: Gadoxetic acid has a substantial liver uptake, is administered at a low dose (0.025 mmol/kg of body weight) and has a short time to delayed phase scanning (20 mins).
Maltese: Gadoxetic acid għandu assorbiment mill-fwied sostanzjali, jingħata f'doża baxxa (0.025 mmol/kg talpiż tal-ġisem) u għandu ħin qasir għal skenjar ta' fażi mdewma (20 minuta).
English: Release of gadolinium in patients with severe renal impairment can result in nephrogenic systemic fibrosis (NSF), a serious and life-threatening syndrome involving fibrosis of the skin, joints and internal organs.
Maltese: Ir-rilaxx ta' gadolinium f'pazjenti b'indeboliment tal-kliewi sever jista' jirriżulta f'fibrożi sistemika nefroġenika (NSF), sindrome serju u ta' periklu għall-ħajja li jinvolvi fibrożi tal-ġilda, tal-ġogi u talorgani interni.
English: • Linear GdCAs are associated with a significant risk of NSF, although current risk minimisation measures appear to be effective based on spontaneous adverse drug reaction reporting.
Maltese: • Il-GdCAs lineari huma assoċjati ma' riskju kbir ta' NSF, għalkemm miżuri ta' minimizzazzjoni tarriskju attwali jidhru li huma effettivi abbażi ta' rappurtar spontanju ta' reazzjoni avversa għal mediċina.
English: • High Gd levels with high inter-individual variability were detected in saline-treated controls.
Maltese: • Ġew identifikati livelli ta' Gd għoljin ma' varjabbiltà interindividwali għolja f'kontrolli kkurati bilmelħ.
English: With regards to the claim of a lower risk of cardiovascular adverse events for Multihance, PRAC considered that nonclinical data as well as available clinical data do not indicate a difference in cardiovascular risk (inducing QT prolongation) within the delayed phase liver imaging agents.
Maltese: Fir-rigward tal-pretensjoni ta' riskju aktar baxx ta' avvenimenti avversi kardjovaskulari għal Multihance, il-PRAC ikkunsidra li data mhux klinika kif ukoll data klinika disponibbli ma jindikawx differenza fir-riskju kardjovaskulari (inkluż it-titwil tal-QT) fl-aġenti tal-immaġni tal-fwied ta' fażi mdewma.
English: Thus, rather weak binding of linear chelators to Gd becomes obvious in various experiments (including Port et al 2009, Sieber et al 2008), and this makes it unlikely that the complex is fully stable in vivo.
Maltese: Għalhekk, irbit pjuttost dgħajjef ta' kelaturi lineari għal Gd isir ovvju f'diversi esperimenti (inkluż Port et al 2009, Sieber et al 2008), u dan jagħmel il-fatt li l-kumpless huwa stabbli b'mod sħiħ in vivo improbabbli.
English: For lifting the suspension, the PRAC recommended that MAHs should provide evidence:
Maltese: Għat-tneħħija tas-sospensjoni, il-PRAC irrakkomanda li l-MAHs għandhom jipprovdu evidenza:
English: Data from non-clinical electron microscopy (EM) studies of brain tissue have also provided evidence of filamentous electron-dense Gd deposits in the regions where T1 hyper intensity has been observed following dosing with gadodiamide.
Maltese: Data minn studji mhux kliniċi ta' mikroskopija tal-elettroni (EM, electron microscopy) tat-tessut talmoħħ ukoll ipprovdiet evidenza ta' depożiti ta' Gd mimlija elettroni filamentużi fir-reġjuni fejn ġiet osservata intensità eċċessiva ta' T1 wara dożaġġ b'gadodiamide.
English: In rat studies, residual Gd found in the rat brain after repeated administration of linear GdCAs was present in at least 3 distinctive forms - soluble small molecules, presumably intact GdCA, soluble macromolecules and to the largest extent an insoluble form.
Maltese: Fi studji fuq il-firien, Gd residwali li nstab fil-moħħ tal-firien wara għoti repetut ta' GdCAs lineari kien preżenti f'tal-inqas 3 forom distinti - molekuli żgħar solubbli, preżubbilment GdCA intatt, makromolekuli solubbli u sal-akbar limitu forma insolubbli.
English: Intra-articular products containing gadopentetic acid and gadoteric acid are administered at very low doses and present a low risk of tissue accumulation.
Maltese: Prodotti intraartikulari li fihom gadopentetic acid u gadoteric acid jingħataw f'dożi baxxi ħafna u jippreżentaw riskju baxx ta' akkumulazzjoni fit-tessut.
English: Fatalities are extremely rare.
Maltese: Ilfatalitajiet huma rari ħafna.
English: Repetitive administration of gadodiamide in rats with renal failure was associated with an increase in the T1 hypersignal in the deep cerebellar nuclei relative to controls with normal renal function.
Maltese: Għoti repetittiv ta' gadodiamide f'firien b'insuffiċjenza talkliewi ġie assoċjat ma' żieda fis-sinjal eċċessiv T1 fin-nuklei ċerebellari fondi relattiva għal kontrolli ma' funzjoni tal-kliewi normali.
English: With regards to the reference to previous assessment conducted at national level (type II variation to extend the indication of Multihance, UK/H/0234/001-002/II/038), it should be noted that the variation application assessment had a different scope than the Article 31 referral procedure and consequently these two procedures are based on a different set of data; therefore a different outcome can be justified.
Maltese: Fir-rigward tar-referenza għall-valutazzjoni preċedenti li saret fuq livell nazzjonali (varjazzjoni tat-tip II sabiex tiġi estiża l-indikazzjoni ta' Multihance, UK/H/0234/001-002/II/038), għandu jiġi nnotat li lvalutazzjoni ta' applikazzjoni ta' varjazzjoni kellha skop differenti mill-proċedura ta' referenza talArtikolu 31 u li sussegwentement dawn iż-żewġ proċeduri huma bbażati fuq sett differenti ta' data; għalhekk riżultat differenti huwa ġustifikat.
English: • Gadolinium has been measured in the brain, both indirectly by studies showing signal intensity increases, and directly by studies measuring gadolinium concentrations with mass spectrometry, including methods that allow localisation in the brain (LA-ICP-MS) and separation of Gd species (GPC-MS).
Maltese: • Gadolinium tkejjel fil-moħħ, kemm indirettament minn studji li juru żidiet fl-intensità tas-sinjal, kif ukoll direttament minn studji li jkejlu l-konċentrazzjonijiet ta' gadolinium bi spettrometrija talmassa, inkluż metodi li jippermettu lokalizzazzjoni fil-moħħ (LA-ICP-MS) u separazzjoni ta' speċi ta' Gd (GPC-MS).
English: The regions of the brain with the greatest potential for brain accumulation are the dentate nucleus and globus pallidus.
Maltese: Ir-reġjuni tal-moħħ bl-akbar potenzjal għal akkumulazzjoni fil-moħħ huma n-nukleu dentat u l-globus pallidus.
English: Macrocyclic GdCAs
Maltese: GdCAs makroċikliċi
English: Interventional clinical studies comparing the different products could be considered unethical.
Maltese: Studji kliniċi ta' intervent li jqabblu l-prodotti differenti jistgħu jiġu kkunsidrati bħala mhux etiċi.
English: One group of experts (including the patient representative) supported the PRAC recommendation (i.e. suspension of linear agents besides Primovist and intraarticular Magnevist) and its rationale, with the exception of the suspension of Multihance for liver imaging in absence of macrocyclic agents for this indication and lack of availability of Primovist in one Member State.
Maltese: Grupp wieħed ta' esperti (inkluż ir-rappreżentat tal-pazjent) appoġġja r-rakkomandazzjoni tal-PRAC (jiġifieri s-sospensjoni ta' aġenti lineari minbarra Primovist u Magnevist intraartikulari) u r-razzjonal tiegħu, bl-eċċezzjoni tas-sospensjoni ta' Multihance għall-immaġni tal-fwied fin-nuqqas ta' aġenti makroċikliċi għal din l-indikazzjoni u n-nuqqas ta' disponibbiltà ta' Primovist fi Stat Membru wieħed.
English: Gadobenic acid undergoes hepatic uptake.
Maltese: Gadobenic acid jgħaddi minn assorbiment mill-fwied.
English: These effects can be mimicked in vitro and will further diminish the stability of the GdCA complex in vivo.
Maltese: Dawn l-effetti jistgħu jiġu limitati in vitro u se jkomplu jnaqqsu l-istabbiltà tal-kumpless GdCA in vivo.