FrancophonIA/ELRC3.0 huggingface dataset:
English: With these uncertainties, conclusions on different or similar behaviour of the different contrast agents studied by McDonald et al. are not possible.
Maltese: B'dawn l-inċertezzi, il-konklużjonijiet dwar imġiba differenti jew simili tal-aġenti ta' kuntrast differenti li ġew studjati minn McDonald et al. mhumiex possibbli.
English: There are several publications in rat models that have demonstrated a T1-weighted signal enhancement in the deep cerebellar nuclei (DCN) - the equivalent to the dentate nucleus (DN) in humans- after administration of the linear agents.
Maltese: Hemm diversi pubblikazzjonijiet fil-mudelli tal-firien li wrew titjib fis-sinjali ppeżat b'T1 fin-nuklei ċerebellari fondi (DCN, deep cerebellar nuclei) - l-ekwivalenti għan-nukleu dentat (DN, dentate nucleus) fil-bnedmin- wara l-għoti tal-aġenti lineari.
English: Perfusion imaging in MRI is typically performed both at rest and during pharmacological stress (for example, with adenosine or dipyridamole), and utilizes a dynamic imaging technique in which signal intensity in the myocardium is evaluated during the passage of the contrast bolus.
Maltese: L-immaġni ta' perfużjoni fl-MRI tipikament issir kemm waqt is-serħan kif ukoll waqt stress farmakoloġiku (pereżempju, b'adenosine jew dipyridamole), u tutilizza teknika tal-immaġni dinamika li fiha l-intensità tas-sinjal fil-mijokardju tiġi evalwata waqt il-passaġġ tal-bolus ta' kuntrast.
English: Toxicity of accumulation of Gd in the brain
Maltese: Tossiċità tal-akkumulazzjoni ta' Gd fil-moħħ
English: PRAC also considered the two linear GdCAs, gadoxetic acid and gadobenic acid in the liver imaging indication.
Maltese: Il-PRAC ikkunsidra wkoll iż-żewġ GdCAs lineari, gadoxetic acid u gadobenic acid fl-indikazzjoni talimmaġni tal-fwied.
English: The benefit-risk balance of medicinal products containing intravenous gadobutrol, gadoteric acid, gadoteridol, gadoxetic acid, intravenous gadobenic acid in the indication of liver imaging, intra-articular gadoteric acid and intra-articular gadopentetic acid is favourable subject to agreed changes to the product information:
Maltese: Il-bilanċ bejn il-benefiċċju u r-riskju ta' prodotti mediċinali li fihom gadobutrol, gadoteric acid, gadoteridol, gadoxetic acid, gadobenic acid ġol-vini fl-indikazzjoni tal-immaġni tal-fwied, gadoteric acid intraartikulari u gadopentetic acid intraartikulari huwa favorevoli soġġetti għal tibdil li ntlaħaq qbil dwaru fl-informazzjoni dwar il-prodott:
English: In view of (a) the evidence suggesting that linear GdCAs release Gd from their chelating ligand molecules due to the low kinetic and thermodynamic stability; (b) the known toxicity of unchelated gadolinium; (c) the data supporting the ability of linear GdCAs to distribute and accumulate in the brain; (d) the fact that linear agents are retained and persist for up to one year or longer in the brain; and (e) the deposition in other tissues with related harm; PRAC considered that there are reasonable and serious concerns raised as to the potential of neurological harm associated with the accumulation of gadolinium in the brain.
Maltese: Fid-dawl ta' (a) l-evidenza li tissuġġerixxi li GdCAs lineari jirrilaxxaw Gd mill-molekuli ligandi kelanti tagħhom minħabba l-istabbiltà kinetika u termodinamika baxxa; (b) it-tossiċità magħrufa ta' gadolinium mhux kelanti; (ċ) id-data li tappoġġja l-abbiltà ta' GdCAs lineari biex jiddistribwixxu u jakkumulaw fil-moħħ; (d) il-fatt li l-aġenti lineari jinżammu u jippersistu sa sena jew aktar fil-moħħ; u (e) id-depożitu f'tessuti oħra bi ħsara relatata; il-PRAC ikkunsidra li hemm tħassib raġonevoli u serju fir-rigward tal-potenzjal ta' ħsara newroloġika assoċjata mal-akkumulazzjoni ta' gadolinium fil-moħħ.
English: In view of a potential difference in the frequency of hypersensitivity reactions, PRAC pointed out that these are known infrequent reactions for all GdCAs.
Maltese: Fid-dawl ta' differenza potenzjali fil-frekwenza ta' reazzjonijiet ta' sensittività eċċessiva, il-PRAC ġibed l-attenzjoni li dawn huma reazzjonijiet mhux frekwenti magħrufa għall-GdCAs kollha.
English: Taking into account the evidence of accumulation of GdCAs in the brain, the fact that linear compounds have been detected in the brain to a much higher amount than the macrocyclic compounds and that they persist in the brain for a longer period, and considering the toxicity of Gd shown in non-clinical studies, the serious concerns about potential neurological harm, deposition in other tissues and its potential risks, and the identified risks associated with the use of linear GdCAs (including the risk of NSF and the gadolinium-associated plaques) and in view of the whole safety profile of these agents, PRAC maintained its conclusion that that the benefit in enhancement of MR images of intravenous linear agents does not outweigh the known and potential risks of these products.
Maltese: Meta tiġi kkunsidrata l-evidenza tal-akkumulazzjoni ta' GdCAs fil-moħħ, il-fatt li l-komposti lineari ġew identifikati fil-moħħ f'ammont ħafna ogħla mill-komposti makroċikliċi u li dawn jippersistu fil-moħħ għal perjodu itwal, u meta tiġi kkunsidrata t-tossiċità ta' Gd murija fi studji mhux kliniċi, it-tħassib serju dwar ħsara newroloġika potenzjali, id-depożitu f'tessuti oħra u r-riskji potenzjali tiegħu, u r-riskji identifikati assoċjati mal-użu ta' GdCAs lineari (inkluż ir-riskju ta' NSF u l-plakek assoċjati ma' gadolinium) u fid-dawl tal-profil tas-sigurtà kollu ta' dawn l-aġenti, il-PRAC żamm il-konklużjoni tiegħu li l-benefiċċju fit-titjib tal-immaġnijiet tal-MR ta' aġenti lineari ġol-vini mhuwiex akbar mir-riskji magħrufa u potenzjali ta' dawn il-prodotti.
English: Regarding the validity of an ex-vivo distribution study by Frenzel et al (2017), PRAC acknowledged the study does not contribute to the understanding in which form exactly Gd-based contrast agents are stored in the body, however PRAC considered that the study confirms, in line with other studies, that linear chelators lead to a higher amount of stored Gd and that there is a difference between linear and macrocyclic chelators in respect to binding to insoluble macromolecules.
Maltese: Rigward il-validità ta' studju dwar id-distribuzzjoni ex-vivo minn Frenzel et al (2017), il-PRAC irrikonoxxa li l-istudju ma jikkontribwixxix għall-fehim f'liema forma eżattament jinħażnu aġenti ta' kuntrast ibbażati fuq Gd fil-ġisem, madankollu l-PRAC ikkunsidra li l-istudju jikkonferma, f'konformità ma' studji oħra, li l-kelaturi lineari jwasslu għal ammont ogħla ta' Gd maħżun u li hemm differenza bejn kelaturi lineari u makroċikliċi fir-rigward tal-irbit ma' makromolekuli insolubbli.
English: They are used for contrast enhancement in magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA).
Maltese: Dawn jintużaw għal titjib ta' kuntrast f'immaġni b'reżonanza manjetika (MRI, magnetic resonance imaging) u f'anġjografija b'reżonanza manjetika (MRA, magnetic resonance imaging).
English: Therefore, pursuant to Article 116 of Directive 2001/83/EC, the CHMP recommends the suspension of the marketing authorisations for intravenous medicinal products containing gadodiamide, gadopentetic acid, and gadoversetamide.
Maltese: Għalhekk, skont l-Artikolu 116 tad-Direttiva 2001/83/KE, is-CHMP jirrakkomanda s-sospensjoni talawtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti mediċinali ġol-vini li fihom gadodiamide, gadopentetic acid, u gadoversetamide.
English: Spontaneous release of Gd from its chelator, competition of Gd with other metals (e.g. in metal rich areas of the brain), and competition of the chelator with other chelators (e.g. macromolecules) can occur in the body.
Maltese: Fil-ġisem jistgħu jseħħu rilaxx spontanju ta' Gd mill-kelatur tiegħu, kompetizzjoni ta' Gd ma' metalli oħra (eż. f'partijiet tal-moħħ b'ħafna metall), u kompetizzjoni talkelatur ma' kelaturi oħra (eż. makromolekuli).
English: Non-chelated gadolinium has been shown to be toxic in non-clinical studies, with effects including cellular necrosis, fibrosis, and lesions related to mineral deposition.
Maltese: Fi studji mhux kliniċi, gadolinium mhux kelatat intwera li huwa tossiku, b'effetti li jinkludu nekrożi ċellulari, fibrożi u leżjonijiet relatati mad-depożitu tal-minerali.
English: • Gadolinium accumulation has also been reported in a range of other tissues including the liver, kidney, muscle, skin and bone in non-clinical and clinical studies.
Maltese: • L-akkumulazzjoni ta' gadolinium ġiet irrapportata wkoll f'medda ta' tessuti oħra inkluż il-fwied, ilkliewi, il-muskoli, il-ġilda u l-għadam fi studji mhux kliniċi u kliniċi.
English: For the linear agent gadoxetic acid that has shown clinical utility in liver imaging, in view of its substantial liver uptake, its administration at a low dose (0.025 mmol/kg of body weight) and the short time to the delayed phase scanning (20 mins), the PRAC considered that it provides an additional benefit to patient management with an exposure to gadolinium that is minimised by the low dose administered and the short time to the delayed phase.
Maltese: Għall-aġent lineari, gadoxetic acid li wera utilità klinika fl-immaġni tal-fwied, fid-dawl tal-assorbiment mill-fwied sostanzjali tiegħu, l-għoti tiegħu f'doża baxxa (0.025 mmol/kg tal-piż tal-ġisem) u ż-żmien qasir għall-iskennjar ta' fażi mdewma (20 minuta), il-PRAC ikkunsidra li dan jipprovdi benefiċċju addizzjonali għall-immaniġġjar tal-pazjent b'esponiment għal gadolinium li jiġi minimizzat mid-doża baxxa mogħtija u ż-żmien qasir għall-fażi mdewma.
English: With regards to the MAH's claim that linear GdCAs do not cause more marked Gd retention and do not have a slower release from brain tissues compared to macrocyclic GdCAs, PRAC considered that the study of McDonald et al. (2017), confirming T1 hyperintensity in the rat lateral dentate nucleus 1 week after administration of macrocyclic agents (Gadovist and Prohance), has several shortcomings:
Maltese: (2017), li jikkonferma sensittività eċċessiva ta' T1 fin-nukleu dentat laterali tal-firien ġimgħa wara l-għoti ta' aġenti makroċikliċi (Gadovist u Prohance), għandu diversi nuqqasijiet:
English: The macrocyclic agent gadobutrol did not show hyperintensity after this time period.
Maltese: L-aġent makroċikliku gadobutrol ma weriex intensità eċċessiva wara dan il-perjodu ta' żmien.
English: Only a transient increase in T1signal intensity and gadolinium concentration (measured by ICP-MS1, thus not distinguishing the molecular form of Gd) was observed with macrocyclic agents.
Maltese: B'aġenti makroċikliċi, ġiet osservata biss żieda tranżitorja fl-intensità tas-sinjal T1 u fil-konċentrazzjoni ta' gadolinium (imkejla b'ICP-MS1, b'hekk ma ssirx distinzjoni tal-forma molekulari ta' Gd).
English: PRAC considered that it is highly unlikely that the release of Gd from gadodiamide is slower in vivo than in vitro.
Maltese: Il-PRAC ikkunsidra li huwa improbabbli li r-rilaxx ta' Gd minn gadodiamide huwa aktar bil-mod in vivo milli in vitro.
English: • The PRAC considered that the risk related to linear intravenous GdCAs gadobenic acid (in all indications besides liver imaging), gadodiamide, gadopentetic acid, and gadoversetamide, taking into account the whole safety profile, including the additional potential risk of harm from brain and other tissues accumulation outweighs the benefits.
Maltese: • Il-PRAC ikkunsidra li r-riskju relatat ma' GdCAs ġol-vini lineari gadobenic acid (fl-indikazzjonijiet kollha minbarra fl-immaġni tal-fwied), adodiamide, gadopentetic acid, u gadoversetamide, meta jiġi kkunsidrat il-profil tas-sigurtà kollu, inkluż ir-riskju potenzjali addizzjonali ta' ħsara minn akkumulazzjoni fil-moħħ u f'tessuti oħra, huwa akbar mill-benefiċċji.
English: Renal impairment is also known to increase the long term retention of Gd in rats in line with the propensity of GdCAs to release Gd in vivo.
Maltese: Ħafna preparazzjonijiet speċjalment ta' aġenti ta' kuntrast ibbażati fuq Gd lineari fihom kelatur ħieles f'eċċess sabiex jaqbdu malajr Gd li jiġi liberat.
English: The precise molecular forms of the soluble macromolecular bound Gd are not known but it is plausible that the macromolecules are bound to a dechelated Gd3+ ion.
Maltese: Il-forom molekulari preċiżi tal-Gd marbut mal-makromolekuli solubbli mhumiex magħrufa iżda huwa plawżibbli li l-makromolekuli huma marbutin ma' jon Gd3+ dekelanti.
English: • PRAC considered options for risk minimisation measures.
Maltese: • Il-PRAC ikkunsidra għażliet għal miżuri tal-minimizzazzjoni tar-riskju.
English: Enhancement of the DN and globus pallidus (GP) in unenhanced scans after previous use of linear GdCAs has been observed across multiple studies in humans.
Maltese: Titjib tad-DN u ta' globus pallidus (GP) fi skens mhux imtejba wara użu preċedenti ta' GdCAs lineari ġie osservat fi studji multipli fuq il-bnedmin.
English: Enhancement after gadobenate dimeglumine (Multihance) or gadopentetate dimeglumine (Magnevist) appeared more progressively compared with gadodiamide.
Maltese: Titjib wara gadobenate dimeglumine (Multihance) jew gadopentetate dimeglumine (Magnevist) deher b'mod aktar progressiv meta mqabbel ma' gadodiamide.
English: In summary, the PRAC considered that there are no new arguments which could convincingly challenge its previous views regarding the dechelation of Gd and hence the low stability of linear GdCA complexes playing a major role for its tissue disposition.
Maltese: IlPRAC ikkonkluda wkoll li kien hemm diffikultajiet prattiċi għal restrizzjoni effettiva tan-numru taddożi mogħtija matul il-ħajja ta' pazjent.
English: • Data on stability, as well as in vitro and non-clinical studies, show that linear gadolinium-containing contrast agents (GdCAs) release gadolinium from the ligand molecules to a greater extent than macrocyclic agents.
Maltese: • Data dwar l-istabbiltà, kif ukoll studji in vitro u mhux kliniċi, juru li aġenti ta' kuntrast li fihom gadolinium, (GdCAs) lineari jirrilaxxaw gadolinium mill-molekuli ligandi sa limitu akbar mill-aġenti makroċikliċi.
English: Smith et al. 2017 described that stored Gd still decreases after one week so that obviously a transiently stored pool exists which is different from the material that persists long-term.
Maltese: Smith et al. 2017 iddeskrivew li Gd maħżun xorta jonqos wara ġimgħa għalhekk ovvjament teżisti ġabra maħżuna b'mod tranżitorju li hija differenti mill-materjal li jippersisti fit-tul.
English: Benefits
Maltese: Benefiċċji
English: Since the finalisation of the referral, several studies in animals and in humans have been published showing accumulation of gadolinium following administration of GdCAs in tissues such as liver, kidney, muscle, skin and bone.
Maltese: Sa mill-finalizzazzjoni tar-referenza, ġew ippubblikati diversi studji fuq l-annimali u fuq il-bnedmin li wrew akkumulazzjoni ta' gadolinium wara l-għoti tal-GdCAs f'tessuti bħall-fwied, il-kliewi, il-muskolu, il-ġilda u l-għadam.
English: • The CHMP considered that the risk related to linear intravenous GdCAs gadobenic acid (in all indications besides liver imaging), gadodiamide, gadopentetic acid, and gadoversetamide, taking into account the whole safety profile, including the additional potential risk of harm from brain and other tissues accumulation outweighs the benefits.
Maltese: • Is-CHMP ikkunsidra li r-riskju relatat ma' GdCAs ġol-vini lineari gadobenic acid (fl-indikazzjonijiet kollha minbarra fl-immaġni tal-fwied), adodiamide, gadopentetic acid, u gadoversetamide, meta jiġi kkunsidrat il-profil tas-sigurtà kollu, inkluż ir-riskju potenzjali addizzjonali ta' ħsara minn akkumulazzjoni fil-moħħ u f'tessuti oħra, huwa akbar mill-benefiċċji.
English: Gadobenic acid also has shown to have clinical utility in the liver and undergoes hepatic uptake but to a lesser extent, requires a high dose (0.05 mmol/kg body weight), and a long time to the onset of delayed phase imaging (40 mins).
Maltese: Gadobenic acid wera wkoll li għandu utilità klinika fil-fwied u jkollu assorbiment mill-fwied iżda għal limitu inqas, jeħtieġ doża għolja (0.05 mmol/kg piż tal-ġisem), u żmien twil għall-bidu tal-immaġni ta' fażi mdewma (40 minuta).
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for medicinal products containing intravenous gadobutrol, gadoteric acid, gadoteridol, gadoxetic acid, intravenous gadobenic acid in the indication of liver imaging, intra-articular gadoteric acid and intraarticular gadopentetic acid.
Maltese: Għalhekk is-CHMP jirrakkomanda l-varjazzjoni għat-termini tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti mediċinali li fihom gadobutrol ġol-vini, gadoteric acid, gadoteridol, gadoxetic acid, gadobenic acid ġol-vini fl-indikazzjoni tal-immaġni tal-fwied, gadoteric acid intraartikulari u gadopentetic acid intraartikulari.
English: Gadolinium-associated plaques
Maltese: Plakek assoċjati ma' gadolinium
English: However, in view of the extent of the hepatic uptake, the high dose (0.05 mmol/kg body weight) required and the long time to the onset of delayed phase imaging (40 mins), the PRAC considered that the benefit of gadobenic acid containing products in all the authorised indication including the liver imaging does not outweigh the potential and identified risks associated to the use of this product.
Maltese: Madankollu, fid-dawl tal-limitu tal-assorbiment mill-fwied, id-doża għolja (0.05 mmol/kg piż tal-ġisem) meħtieġa u ż-żmien twil għall-bidu ta' immaġni ta' fażi mdewma (40 minuta), il-PRAC ikkunsidra li l-benefiċċju ta' prodotti li fihom gadobenic acid fl-indikazzjonijiet awtorizzati kollha inkluż l-immaġni tal-fwied mhuwiex akbar mir-riskji potenzjali u identifikati assoċjati mal-użu ta' dan il-prodott.
English: With regards to the claim that virtually no Gd becomes liberated from gadodiamide in the body, PRAC noted that at 37°C in human serum Gd rapidly dissociates from its chelator in vitro (Frenzel et al. 2008).
Maltese: Fir-rigward tal-pretensjoni li virtwalment l-ebda Gd ma jiġi liberat minn gadodiamide fil-ġisem, il-PRAC innota li f'37°C fis-seru tal-bniedem, Gd jiddissoċja malajr mill-kelatur tiegħu in vitro (Frenzel et al. 2008).
English: Two linear GdCAs, gadoxetic acid and gadobenic acid, have been shown to have an uptake by hepatocytes and are the only liver-specific agents that can provide both the dynamic and the delayed phase imaging.
Maltese: Għalhekk, ilPRAC ikkunsidra li l-benefiċċji ta' gadobenic acid u gadoxetic acid huma akbar mir-riskji tagħhom filkuntest ta' immaġni tal-fwied ta' fażi mdewma.
English: PRAC considered potential clinical studies to be conducted in order to fully address the serious concerns of plausible neurological effects.
Maltese: Dan jindika b'mod ċar li dekelazzjoni potenzjali fil-ġisem hija fenomenu rikonoxxut.
English: With regards to the claim that gadodiamide (Omniscan) has a unique indication in myocardial perfusion imaging PRAC considered that the whole body MRI indication encompasses imaging of the heart, including myocardial perfusion imaging.
Maltese: Fir-rigward tad-dikjarazzjoni li gadodiamide (Omniscan) għandu indikazzjoni unika f'immaġni ta' perfużjoni mijokardijaka, il-PRAC qies li l-indikazzjoni tal-MRI tal-ġisem kollu tinkludi immaġni tal-qalb, inkluż immaġni ta' perfużjoni mijokardijaka.
English: Overall, the experts expressed divergent views concerning the risk minimisation measures.
Maltese: B'mod globali, l-esperti esprimew fehmiet diverġenti rigward il-miżuri tal-minimizzazzjoni tar-riskju.
English: The PRAC considered that a 2nd ad-hoc expert meeting was warranted to address some of the aspects that formed part of the detailed grounds submitted by Bracco and GE Healthcare.
Maltese: Il-PRAC ikkunsidra li laqgħa tal-esperti ad-hoc oħra kienet iġġustifikata sabiex tindirizza xi wħud millaspetti li jiffurmaw parti mir-raġunijiet dettaljati ppreżentati minn Bracco u GE Healthcare.
English: Another study showed that administration of the linear GdCAs gadodiamide and gadobenic acid directly into the cerebrospinal fluid (CSF) resulted in increased signal intensity in the DCN in rats up to 5 weeks after administration.
Maltese: Studju ieħor wera li l-għoti tal-GdCAs lineari gadodiamide u gadobenic acid direttament fil-fluwidu ċerebrospinali (FĊS) irriżulta f'intensità tas-sinjal miżjuda fid-DCN fil-firien sa 5 ġimgħat wara l-għoti.
English: • The CHMP took into account that the linear intravenous agents, Multihance (gadobenic acid) and Primovist (gadoxetic acid), undergo hepatic uptake, and therefore have clinical utility for imaging poorly vascularised hepatic lesions, especially in the delayed phase imaging, that cannot be adequately studied with agents without hepatic uptake and thus allowing early diagnosis of potentially life threatening diseases.
Maltese: • Il-PRAC ikkunsidra li l-aġenti ġol-vini lineari, Multihance (gadobenic acid) u Primovist (gadoxetic acid), jgħaddu minn assorbiment mill-fwied, u għalhekk għandhom utilità klinika għall-immaġni ta' leżjonijiet fil-fwied vaskularizzati ħażin, speċjalment fl-immaġni ta' fażi mdewma, li ma tistax tiġi studjata b'mod adegwat b'aġenti mingħajr assorbiment mill-fwied u li għalhekk jippermettu dijanjożi bikrija ta' mard potenzjalment ta' periklu għall-ħajja.
English: Deposition of gadolinium in the brain
Maltese: Depożitu ta' gadolinium fil-moħħ
English: For the linear agents evaluated in non-clinical studies the T1 signal intensity in the DCN has been shown to persist for at least 1 year without any reduction in intensity.
Maltese: Għall-aġenti lineari evalwati fi studji mhux kliniċi, l-intensità tas-sinjal T1 fid-DCN intweriet li kienet persistenti għal tal-inqas sena mingħajr ebda tnaqqis fl-intensità.
English: Toxicity of GdCAs has primarily been attributed to the dissociation of Gd from the chelated complexes.
Maltese: It-tossiċità ta' GdCAs ġiet attribwita primarjament għad-dissoċjazzjoni ta' Gd mill-kumplessi kelanti.
English: A restriction by number of doses may not be possible in clinical practice, because previous exposures to GdCAs may not have been recorded sufficiently with regard to the type of GdCA used.
Maltese: Restrizzjoni skont in-numru taddożi tista' ma tkunx possibbli fil-prattika klinika, għax jista' jkun li l-esponimenti preċedenti għal GdCAs ma jkunux ġew irreġistrati biżżejjed fir-rigward tat-tip ta' GdCA użat.
English: On 9 March 2016, the European Commission triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of gadolinium containing medicinal products and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Maltese: Fid-9 ta' Marzu 2016, il-Kummissjoni Ewropea tat bidu għal referenza skont l-Artikolu 31 tadDirettiva 2001/83/KE bħala riżultat tad-data dwar il-farmakoviġilanza u talbet lill-PRAC biex jivvaluta limpatt tat-tħassib imsemmi hawn fuq dwar il-bilanċ bejn il-benefiċċju u r-riskju ta' prodotti mediċinali li fihom gadolinium u biex joħroġ rakkomandazzjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq rilevanti għandhomx jinżammu, jiġu varjati, sospiżi jew revokati.
English: • the significance of the study by Welk et al. (2016) is limited and the conclusion that these results do not indicate an association between exposure to GdCAs and the development of parkinsonism is premature.
Maltese: (2016) huwa limitat u l-konklużjoni li dawn ir-riżultati ma jindikawx assoċjazzjoni bejn l-esponiment għal GdCAs u l-iżvilupp tal-parkinsoniżmu huwa prematur.