FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, a literature review retrieved more than 100 publications related to hepatotoxicity of ketoconazole.
Maltese: Barra minn hekk, reviżjoni tal-letteratura sabet aktar minn 100 pubblikazzjoni relatati malepatotossiċità ta' ketoconazole.
English: The MAH proposed to withdraw all indications that require prolonged treatment at higher dosages, e.g., systemic mycoses requiring treatment for 6 months or longer taking into account the fact that hepatotoxicity has usually been reported after extensive cumulative exposure to ketoconazole and to limit indications to Malassezia folliculitis, Tinea capitis and chronic mucocutaneous candidiasis in patients who had either developed intolerance or failed to respond to alternative oral and/or IV antifungal therapy.
Maltese: Sabiex inaqqas ir-riskji, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ippropona li jelimina lindikazzjonijiet kollha li jeħtieġu kura fit-tul f'dożi ogħla, eż. mikożi sistemika li teħtieġ kura għal 6 xhur jew aktar, meta jitqies li l-epatotossiċità ġeneralment ġiet irrapportata wara esponiment kumulattiv estensiv għal ketoconazole, u li jillimita l-indikazzjonijiet għall-Malassezia follikulite, Tinea capitis u kandidijasi mukokutanja kronika f'pazjenti li jew ikunu żviluppaw intolleranza jew ma rrispondewx għal terapija antifungali orali u/jew fil-vini (IV) alternattiva.
English: • The Committee considered that available data from pre-clinical studies, clinical trials, postmarketing spontaneous case reports, pharmaco-epidemiological studies and published literature have shown that the use of oral ketoconazole-containing products is associated with a high risk of serious hepatotoxicity, best demonstrated by the causality assessments of fatal/life-threatening hepatotoxicity cases;
Maltese: • Il-Kumitat ikkunsidra li d-dejta disponibbli minn studji prekliniċi, provi kliniċi, rapporti ta' każijiet spontanji wara t-tqegħid fis-suq, studji farmako-epidemjoloġiċi u l-letteratura ppubblikata, uriet li l-użu ta' prodotti li fihom ketoconazole orali huwa assoċjat ma' riskju għoli ta' epatotossiċità serja, li ntwera l-aħjar mill-valutazzjonijiet tal-kawżalità ta' każijiet ta' epatotossiċità fatali/ta' periklu għal-ħajja;
English: Indeed, the SAG considered that the activity of the newer systemic antifungals is expected to be superior to ketoconazole.
Maltese: Fil-fatt, l-SAG qies li l-attività tal-antifungali sistemiċi ġodda hija mistennija li tkun superjuri għal ketoconazole.
English: This was followed by the registration of topical pharmaceutical forms such as cream /ointment/shampoo.
Maltese: Dan kien segwit mir-reġistrazzjoni ta' forom farmaċewtiċi għal użu topiku bħal krema/ingwent/xampù.
English: The demonstrate the effectiveness of ketoconazole in these indications, the MAH provided a total of 40 cases, 19 cases based on clinical visits of two clinicians who kept a registry of such patients and 21 cases based on a review of the literature.
Maltese: Biex juri l-effikaċja ta' ketoconazole f'dawn l-indikazzjonijiet, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ipprovda total ta' 40 każ, 19-il każ ibbażati fuq il-viżti kliniċi ta' żewġ ġesturi ta' klinika li żammew reġistru ta' dawn il-pazjenti u 21 każ ibbażati fuq reviżjoni tal-letteratura.
English: In Europe, oral formulations of ketoconazole are currently approved in 20 Member States as well as in Iceland and Norway.
Maltese: Stat Membru kif ukoll fl-Islanda u n-Norveġja.
English: The CHMP, having considered the data submitted by the MAH, was of the opinion that the proposed risk minimisation activities were not appropriate to reduce the risks to an acceptable level taking into account the restrictions and warnings already in place.
Maltese: Is-CHMP, wara li kkunsidra d-dejta ppreżentata mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq, kien tal-opinjoni li l-attivitajiet proposti għall-minimizzazzjoni tar-riskju ma kinux adatti sabiex ir-riskji jitnaqqsu għal livell aċċettabbli meta jitqiesu r-restrizzjonijiet u t-twissijiet li diġà hemm fis-seħħ.
English: Taking into account all the above, the CHMP could not identify any situation that could justify exposing a patient to the level of hepatotoxicity of ketoconazole for oral use.
Maltese: Barra minn hekk, mhumiex kummerċjalment disponibbli testijiet dwar is-suxxettibbiltà għal ketoconazole.
English: Seven fatal/life-threatening cases were reported with event dates after 2006 i.e., after the CCDS update that contained substantial hepatotoxicity-related revisions.
Maltese: Seba' każijiet fatali/ta' periklu għall-ħajja kienu rrappurtati b'dati tal-avveniment wara l2006, jiġifieri wara l-aġġornament tas-CCDS li kien fih reviżjonijiet sostanzjali relatati malepatotossiċità.
English: Uncertainties still remain about the liver toxicity mechanism of ketoconazole.
Maltese: Ġew identifikati diversi mekkaniżmi potenzjali għal din it-tossiċità iżda għad baqa' d-dubji.
English: Additional expert advice was sought from an ad-hoc expert group.
Maltese: Kien imfittex parir espert addizzjonali minn grupp ta' esperti ad-hoc.
English: Some of authors argue that a positive net fluid balance is associated with a decrease in organ perfusion and an increased mortality (e.g. Sadaka F et al. 2013, Payen D et al. 2008).
Maltese: Xi wħud mill-awturi jargumentaw li bilanċ pożittiv nett tal-fluwidu huwa assoċjat ma' tnaqqis fil-perfużjoni tal-organi u żieda fil-mortalità (eż. Sadaka F et al. 2013, Payen D et al. 2008).
English: In hypovolaemic patients with normal pulmonary function, the use of colloids to maintain colloid-osmotic pressure may limit the development of peripheral as well as pulmonary oedema (Vincent JL 2000).
Maltese: F'pazjenti ipovolaemiċi b'funzjoni pulmonari normali, l-użu ta' kollojdi biex tinżamm il-pressjoni kollojde-osmotika jista' jillimita l-iżvilupp ta' edema periferali kif ukoll pulmonari (Vincent JL 2000).
English: • The PRAC noted the conclusions of a review under article 31 of Directive 2001/83/EC.
Maltese: L-ewwel reviżjoni inizjalment inbdiet skont ilqafas tal-Artikolu 31 tad-Direttiva 2001/83//KE.
English: In addition, in the BaSES study, the hospitalisation time was significantly reduced in patients treated with 6% HES 130/0.4 compared to 0.9% NaCl.
Maltese: Barra minn hekk, fl-istudju BaSES, ir-rikoveru fl-isptar kien imnaqqas b'mod sinifikanti f'pazjenti kkurati b'6 % HES 130/0.4 meta mqabbel ma' 0.9 % NaCl.
English: Results from the RaFTinG registry in intensive care units, an observational, non-randomised study aiming to gather more information in ‘real-life' clinical practice showed no statistically significant differences between patients treated with crystalloids only (n=2482) and those treated with colloids (all HES preparations and gelatin, n=2063) for the endpoints of 90-day mortality.
Maltese: RaFTinG f'unitajiet tal-kura intensiva, studju mhux randomizzat ta' osservazzjoni, li għandu l-għan li jiġbor aktar tagħrif fil-prattika klinika tal-”ħajja reali” ma wrew ebda differenza statistikament sinifikanti bejn pazjenti kkurati b'kristallojdi biss (n =2482) u dawk ikkurati b'kollojdi (il-preparazzjonijiet HES u l-ġelatina kollha, n = 2063) għall-punti ta' tmiem ta' mortalità ta' 90 jum.
English: Hydroxyethyl starch (HES) solutions for infusion include products with starch derived from potato or corn with different molecular weights and substitution ratios.
Maltese: Is-soluzzjonijiet ta' lamtu tal-Hydroxyethyl (HES) għall-infużjoni jinkludu l-prodotti b'lamtu derivat mill-patata jew il-qamħirrun b'piżijiet molekulari u proporzjonijiet ta' sostituzzjoni differenti.
English: Whilst recognising the limitations of these studies which included limited size and short duration of follow-up, the PRAC noted that some volume sparing effect was reported in Madi-Jebara et al. 2008, that suggested that HES 130/0.4 6% seems to have benefits over twice the volume of Ringer's lactate in preventing spinal anaesthesia induced hypotension.
Maltese: Filwaqt li jirrikonoxxi l-limitazzjonijiet ta' dawn l-istudji li inkludew daqs limitat u perjodu qasir ta' segwitu, il-PRAC innota li xi effett ta' ffrankar mill-volum kien irrapportat f'Madi-Jebara et al. 2008, li ssuġġerixxa li HES 130/0.4 6 % jidher li għandu benefiċċji aktar minn darbtejn il-volum ta' lattilat ta' Ringer fil-prevenzjoni tal-pressjoni baxxa indotta millanestesija spinali.
English: • The PRAC considered, in view of the new evidence which includes data from clinical trials, further expert advice, new proposals for additional risk minimisation measures, including restrictions on use and a commitment from the MAHs to perform additional studies in patients with trauma and in elective surgery, that the benefit of hydroxyethyl starch containing products outweighs the risk in the treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient.
Maltese: • Il-PRAC ikkunsidra li, fid-dawl tal-evidenza l-ġdida li tinkludi dejta minn provi kliniċi, pariri esperti ulterjuri, proposti ġodda għal miżuri addizzjonali għall-minimizzazzjoni tar-riskju, inkluż restrizzjonijiet fuq l-użu u impenn mill-MAHs biex iwettqu studji addizzjonali f'pazjenti bi trawma jew kirurġija elettiva, li l-benefiċċju tal-prodotti li fihom il-lamtu tal-Hydroxyethyl huwa akbar mir-riskju fil-kura ta' ipovolemija minħabba telf ta' demm qawwi meta l-kristallojdi waħedhom mhumiex ikkunsidrati biżżejjed.
English: Overall summary of the scientific evaluation of solutions for infusion containing hydroxyethyl starch medicinal products by PRAC
Maltese: Sommarju globali tal-evalwazzjoni xjentifika għall-infużjoni li fiha prodotti mediċinali billamtu tal-Hydroxyethyl mill-PRAC
English: • The PRAC considered that the use of hydroxyethyl starch is associated with an increased risk of mortality and renal replacement therapy or renal impairment in patients with sepsis, critically ill and burn patients.
Maltese: • Il-PRAC ikkunsidra li l-użu tal-lamtu tal-hydroxyethyl huwa assoċjat ma' riskju akbar ta' mortalità u terapija ta' sostituzzjoni renali jew insuffiċjenza renali f'pazjenti b'sepsis, morda b'mod kritiku u li nħarqu.
English: In addition, two phase IV randomised clinical trials with an appropriate control and clinically meaningful endpoints will need to be conducted to provide more evidence on the efficacy and safety, including the risk of 90-day mortality and renal failure, in perioperative and trauma populations.
Maltese: IV b'kontroll xieraq u punti ta' tmiem klinikament sinifikanti biex tiġi pprovduta aktar evidenza dwar l-effikaċja u ssigurtà, inkluż ir-riskju ta' mortalità ta' 90 jum u l-insuffiċjenza renali, f'popolazzjonijiet perioperattivi u li għaddew minn trawma.
English: Some publications also suggest that colloids might help to prevent positive fluid balance and/or overinfusion of fluids (Wills 2005, Naing CM and Win DK 2010).
Maltese: Naing CM u Win DK 2010).
English: The PRAC issued a recommendation on available data for this review in June 2013, concluding that HES solutions should be suspended in all patient populations.
Maltese: Il-PRAC ħareġ rakkomandazzjoni dwar id-dejta disponibbli għal din ir-reviżjoni f'Ġunju 2013, fejn ikkonkluda li s-soluzzjonijiet HES għandhom jiġu sospiżi fil-popolazzjonijiet ta' pazjenti kollha.
English: It is on the basis of the totality of the data available, including the new evidence, that the PRAC issued conclusion on the procedure provided for in Article 107i of Directive 2001/83/EC in October 2013.
Maltese: Huwa fuq il-bażi tat-totalità tad-dejta disponibbli, inkluż l-evidenza l-ġdida, li l-PRAC ħareġ konklużjoni dwar il-proċedura prevista fl-Artikolu 107i tad-Direttiva 2001/83/KE f'Ottubru 2013.
English: New results from CRYSTAL have also become available.
Maltese: Tqiegħdu wkoll għad-dispożizzjoni riżultati ġodda minn CRYSTAL.
English: Under the framework of Article 107i of Directive 2001/83/EC, the PRAC considered recommendations on HES rendered in the referral under Article 31 of Directive 2001/83/EC and also reviewed available data including clinical studies, meta-analyses of clinical studies, post-marketing experience, responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations, spontaneous reports on the safety and efficacy of hydroxyethyl starch containing products for solutions for infusion, as well as stakeholders' submissions in particular with regards to the risk of mortality and renal failure.
Maltese: Skont il-qafas tal-Artikolu 107i tad-Direttiva 2001/83/KE, il-PRAC ikkunsidra r-rakkomandazzjonijiet dwar l-HES mogħtija fir-riferiment skont l-Artikolu 31 tad-Direttiva 2001/83/KE u rriveda wkoll id-dejta disponibbli inkluż l-istudji kliniċi, il-meta-analiżijiet tal-istudji kliniċi, l-esperjenza ta' wara t-tqegħid fissuq, ir-risponsi sottomessi mid-detenturi għat-tqegħid fis-suq (MAHs) bil-miktub u bi spjegazzjonijiet bil-fomm, ir-rapporti spontanji dwar is-sigurtà u l-effikaċja tal-prodotti li fihom il-lamtu talHydroxyethyl għal soluzzjonijiet għall-infużjoni, kif ukoll is-sottomissjonijiet tal-partijiet interessati b'mod partikolari fir-rigward tar-riskju ta' mortalità u l-insuffiċjenza renali.
English: Detailed explanation for the differences from the PRAC recommendation
Maltese: Spjegazzjoni dettaljata għad-differenzi mir-rakkomandazzjoni tal-PRAC
English: The CMDh considered the below PRAC recommendations following the procedure under Article 107i of Directive 2001/83/EC dated 10 October 2013 with regards to Hydroxyethyl starch containing medicinal products solutions for infusion:
Maltese: Is-CMDh jikkunsidra r-rakkomandazzjonijiet tal-PRAC li jsegwu l-proċedura skont l-Artikolu 107i tadDirettiva 2001/83/KE datata l-10 ta' Ottubru 2013 fir-rigward tal-lamtu tal-Hydroxyethyl li fih soluzzjonijiet ta' prodotti mediċinali għall-infużjoni:
English: Benefit risk balance
Maltese: Ir-riżultati mir-reġistru
English: The MAHs should submit within 6 months of the European Commission Decision, the core elements (including protocol of DUS, protocols of the RCTs) of a risk management plan in EU format and this was included in Annex IV.
Maltese: L-MAHs għandhom jissottomettu fi żmien 6 xhur mid-Deċiżjoni tal-Kummissjoni Ewropea, l-elementi ewlenin (inkluż il-protokoll tad-DUS, il-protokolli tal-RCTs) tal-pjan ta' ġestjoni tar-riskju fil-format tal-UE u dan kien inkluż fl-Anness
English: • The PRAC concluded that hydroxyethyl starch containing products should be contraindicated in patients with sepsis, in critically ill and burn patients.
Maltese: • Il-PRAC ikkonkluda li l-prodotti li fihom il-lamtu tal-Hydroxyethyl għandhom jiġu kontraindikati f'pazjenti b'sepsis u f'dawk morda b'mod kritiku u li nħarqu.
English: The CMDh having considered the PRAC recommendation dated 10 October 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC and the oral explanations by the Marketing Authorisation Holders on 21 October 2013, reached a position on the variation to the terms of the marketing authorisations of Hydroxyethyl starch solutions for infusion containing medicinal products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV.
Maltese: Konsegwentament, inbdiet it-tieni reviżjoni tas-soluzzjonijiet HES skont l-Artikolu 107i tad-Direttiva 2001/83/KE, li kienet qiegħda titmexxa separatament iżda b'mod parallel mal-eżaminazzjoni mill-ġdid tal-Artikolu 31, li kienet ser tiġi ffinalizzata wkoll f'Ottubru 2013.
English: Some benefit for elective surgical patients has also been shown in short-term surrogate hemodynamic outcomes along with a modest volume sparing effect (Hartog et al. 2011).
Maltese: Intwera wkoll xi benefiċċju għal pazjenti kirurġiċi elettivi f'riżultati emodinamiċi surrogati għal żmien qasir flimkien ma' effett ta' ffrankar fil-volum modest (Hartog et al. 2011).
English: The experts suggested that benefit of HES may be seen in particular in perioperative bleeding.
Maltese: L-esperti ssuġġerew li l-benefiċċju tal-HES jista' jiġi osservat b'mod partikolari fi fsada perioperattiva.
English: In view of the totality of the evidence available in the procedure under Article 107i of Directive 2001/83/EC, the PRAC considered that Hydroxyethyl starch should be restricted to the treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient subject to agreed restrictions, contraindications, warnings, other changes to the product information and additional risk minimisation measures.
Maltese: Fid-dawl tat-totalità tal-evidenza disponibbli fil-proċedura skont l-Artikolu 107i tadDirettiva 2001/83/KE, il-PRAC ikkunsidra li l-lamtu tal-Hydroxyethyl għandu jiġi ristrett fil-kura ta' ipovolemija minħabba telf ta' demm qawwi meta l-kristallojdi waħedhom mhumiex ikkunsidrati biżżejjed soġġett għar-restrizzjonijiet, il-kontraindikazzjonijiet, it-twissijiet, bidliet oħra fl-informazzjoni tal-prodott u miżuri addizzjonali għall-minimizzazzjoni tar-riskju miftiehma.
English: Despite the studies' limitations which were noted, the results from the CRYSTAL study comparing colloids to crystalloids showed that in patients with hypovolaemia, the use of colloids vs crystalloids did not result in a significant difference in 28-day mortality.
Maltese: Minkejja l-limitazzjonijiet tal-istudji li kienu nnotati, ir-riżultati mill-istudju ta' CRYSTAL li qabbel il-kollojdi ma' kristallojdi wera li f'pazjenti b'ipovolemija, l-użu ta' kollojdi meta mqabbel mal-kristallojdi ma rriżultax f'differenza sinifikanti filmortalità ta' 28 jum.
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 107i of Directive 2001/83/EC, for hydroxyethyl starch containing products for solutions for infusion.
Maltese: • Il-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) ikkunsidra l-proċedura skont l-Artikolu 107i tad-Direttiva 2001/83/KE, għal prodotti li fihom il-lamtu tal-hydroxyethyl għal soluzzjonijiet għall-infużjoni.
English: Although the mechanisms by which increased renal injury and mortality occur is not well established, it is possible that the degree of inflammatory processes seen in sepsis and critically ill patients is greater and associated with significant capillary leakage compared with other patient populations such as the perioperative setting after elective surgery or un-complicated trauma where the systematic inflammatory process and the extent of capillary leak may be lower.
Maltese: Minkejja li l-mekkaniżmi li permezz tagħhom iseħħu ħsara renali u mortalità, huwa possibbli li l-grad tal-proċessi infjammatorji murija f'sepsis u f'pazjenti morda b'mod kritiku huwa akbar u assoċjat ma' tnixxija kapillari sinifikanti meta mqabbel ma' popolazzjonijiet ta' pazjenti oħra bħall-iffissar perioperattiv wara kirurġija elettiva jew trawma mhux ikkumplikata meta lproċess ta' infjammazzjoni sistematika u l-estent tat-tnixxija kapillari jistgħu jkunu aktar baxxi.
English: Although 90-day mortality was lower among patients receiving colloids, this requires further investigations.
Maltese: Minkejja li l-mortalità ta' 90 jum kienet aktar baxxa fost il-pazjenti li rċevew kollojdi, din teħtieġ investigazzjonijiet ulterjuri.
English: HES products are contraindicated in patients with renal impairment or renal replacement therapy but the contraindications should also be extended to include other patient populations including patients with sepsis, critically ill patients and burns patients.
Maltese: Il-prodotti HES huma kontraindikati f'pazjenti b'insuffiċjenza renali jew b'terapija ta' sostituzzjoni renali iżda l-kontraidikazzjonijiet għandhom jiġu estiżi biex jinkludu popolazzjonijiet ta' pazjenti oħrajn inkluż pazjenti b'sepsis, pazjenti morda b'mod kritiku u pazjenti li nħarqu.
English: Meybohm P et al. 2013 suggest that use of HES should be restricted to the initial phase of volume resuscitation with a maximum time interval of 24 h. Martin et al 2002 showed that HES treatment resulted in a significantly lower estimated blood loss and that there was no difference in red blood cells, or blood product utilisation among the groups.
Maltese: Meybohm P et al. 2013 jissuġġerixxi li l-użu ta' HES għandu jiġi ristrett għall-fażi inizjali tal-volum ta' risuxxitazzjoni b'intervall ta' ħin massimu ta' 24 siegħa.
English: However, with regards to the two phase IV randomised clinical trials (RCTs) requested to provide more evidence on the efficacy and safety in perioperative and trauma populations, including the risk of 90-day mortality and renal failure, , the CMDh encouraged the MAHs to jointly submit common study protocols.
Maltese: Madankollu, fir-rigward taż-żewġ provi kliniċi randomizzati (RCTs) talab biex tiġi pprovduta aktar evidenza dwar l-effikaċjà u s-sigurtà fil-popolazzjonjiet perioperattivi u bi trawma, inkluż ir-riskju ta' 90 jum mortalità u insuffiċjenza renali, is-CMDh ħeġġeġ lill-MAHs biex jissottomettu b'mod konġunt protokolli ta' studju komuni.
English: The PRAC concluded that the benefit-risk balance for hydroxyethyl starch containing medicinal products remains favourable in treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient subject to the agreed restrictions, contraindications, warnings, other changes to the product information and additional risk minimisation measures.
Maltese: Il-PRAC ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju għall-prodotti mediċinali li fihom il-lamtu talhydroxyethyl jibqa' wieħed favorevoli fil-kura ta' ipovolemija minħabba telf ta' demm qawwi meta lkristallojdi waħedhom mhumiex ikkunsidrati biżżejjed soġġett għar-restrizzjonijiet, ilkontraindikazzjonijjiet, it-twissijiet, bidliet oħra fl-informazzjoni tal-prodott u miżuri addizzjonali għallminimizzazzjoni tar-riskju miftiehma.
English: However, for the current procedure under Article 107i of Directive 2001/83/EC the PRAC reviewed new available data, with a focus on risk of mortality and renal failure, including clinical studies, meta-analyses of clinical studies, post-marketing experience, responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations and stakeholders' submissions.
Maltese: • Il-PRAC innota l-konklużjonijiet ta' reviżjoni skont l-Artikolu 31 tad-Direttiva 2001/83/KE. Madankollu, għall-proċedura attwali skont l-Artikolu 107i tad-Direttiva 2001/83/KE, il-PRAC irreveda d-dejta l-ġdida disponibbli, b'fokus fuq il-mortalità u l-insuffiċjenza renali, inkluż listudji kliniċi, il-meta-analiżijiet tal-istudji kliniċi, l-esperjenza ta' wara t-tqegħid fis-suq, irrisponsi sottomessi mid-detenturi tal-awtorizzazzjonijiet għat-tqegħid fis-suq (MAHs) bilmiktub u bi spjegazzjonjiet bil-fomm u s-sottomissjonijiet tal-partijiet interessati.
English: In accordance with the EU legislation, this type of action required that an EU review procedure be carried out.
Maltese: F'konformità mal-leġiżlazzjoni tal-UE, din it-tip ta' azzjoni ħtieġet li titwettaq proċedura ta' reviżjoni tal-UE.
English: Following requests for re-examination by marketing authorisation holders (MAHs), the PRAC confirmed its previous position under the Article 31 in October 2013.
Maltese: Wara t-talbiet għal eżaminazzjoni mill-ġdid mid-detenturi tal-awtorizzazzjonijiet għat-tqegħid fis-suq (MAHs), il-PRAC ikkonferma l-pożizzjoni preċedenti tiegħu skont l-Artikolu 31 f'Ottubru 2013.
English: Hamaji et al 2013 also showed that significantly fewer red blood cell transfusions were required in the HES group.
Maltese: Hamaji et al 2013 wera ukoll li kienu meħtieġa anqas transfużjonijiet taċċelloli tad-demm ħomor fil-grupp HES.
English: The CMDh also considered that the direct healthcare professional communication (DHPC) should be submitted to the NCAs where HES products are marketed, within one week of the CMDh adopted position as per agreed communication plan.
Maltese: Is-CMDh ikkunsidra wkoll li l-komunikazzjoni professjonali tal-kura tas-saħħa diretta (DHPC) għandha tiġi sottomessa lill-NCAs fejn huma kkummerċalizzati prodotti HES, fi żmien ġimgħa minn meta tiġi adottata l-pożizzjoni mis-CMDh skont il-pjan ta' komunikazzjoni miftiehem.