FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of adalimumab was assessed in a randomized, double-masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew ivvalutati fi studju kkontrollat, b'mod każwali, double masked, studju ikkontrollat b'90 pazjent pedjatriku minn 2 sa <18-il sena b'uveite anterjuri mhux infettiva assoċjata ma' JIA attiva li kienu refrattarji għal mill-inqas 12-il ġimgħa bi trattament ta' methotrexate.
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Maltese: Numru ta' l-EU Isem inventat Qwwa Għamla farmaċewtika
English: EU Number
Maltese: Mnejn jingħata
English: Revised CMDh position
Maltese: Pożizzjoni tas-CMDh riveduta
English: Hydroxyethyl starch (HES) solutions for infusion contain starch with different molecular weights (mainly 130kD; 200kD) and substitution ratio (the number of hydroxyethyl groups per glucose molecule).
Maltese: Soluzzjonijiet għall-infużjoni ta' lamtu idrossietili (HES) fihom lamtu b'piżijiet molekulari differenti (prinċipalment 130kD; 200kD) u proporzjon ta' sostituzzjoni (in-numru ta' gruppi idrossietili għal kull molekula tal-glukożju).
English: • Proposals for additional risk minimisation measures and pharmacovigilance activities
Maltese: • Proposti għal miżuri addizzjonali ta' minimizzazzjoni tar-riskju u attivitajiet ta' farmakoviġilanza
English: Perner A, Haase N, Guttormsen AB et al. Hydroxyethyl starch 130/0.42 versus ringer's acetate in severe sepsis.
Maltese: Hydroxyethyl starch 130/0.42 versus ringer's acetate in severe sepsis.
English: The PRAC also consulted an ad-hoc expert group and considered carefully views expressed during the meeting that took place on 18 December 2017.
Maltese: Il-PRAC ikkonsulta wkoll ma' grupp ta' esperti ad hoc u qies b'attenzjoni opinjonijiet espressi matul illaqgħa li seħħu fit-18 ta' Diċembru 2017.
English: In 2012 and 2013, PRAC reviewed the benefits and risks of HES solutions for infusion in the treatment and prophylaxis of hypovolaemia, within Article 311 and 107i2 referral procedures.
Maltese: Fl-2012 u fl-2013, il-PRAC irreveda l-benefiċċji u r-riskji ta' soluzzjonijiet għall-infużjoni ta' HES fil-kura u l-profilassi ta' ipovolemija, fi ħdan il-proċeduri ta' referenza tal-Artikolu 311 u 107i2.
English: On 5th July 2017 and 9th October 2017, results from two DUSs on the effectiveness of the implemented risk minimisation measures have become available.
Maltese: Fil-5 ta' Lulju 2017 u fid-9 ta' Ottubru 2017, saru disponibbli riżultati minn żewġ DUSs dwar l-effettività tal-miżuri tal-imminimizzar tar-riskju implimentati.
English: • The PRAC conclusions of previous reviews under Article 31 of Directive and Article 107i of Directive 2001/83/EC were that HES solutions for infusion are associated with an increased risk of mortality and renal failure in patients with sepsis or critical illness.
Maltese: • Il-konklużjonijiet tal-PRAC ta' reviżjonijiet preċedenti skont l-Artikolu 31 tad-Direttiva u lArtikolu 107i tad-Direttiva 2001/83/KE kienu li s-soluzzjonijiet għall-infużjoni ta' HES huma assoċjati ma' żieda fir-riskju ta' mortalità u insuffiċjenza tal-kliewi f'pazjenti b'sepsis jew b'mard serju.
English: • A reference to section 4.3 of the SmPC will avoid undermining the importance of other contraindications, and ensure these continue to be adhered to.
Maltese: • Referenza għas-sezzjoni 4.3 tal-SmPC tevita li ddgħajjef l-importanza ta' kontraindikazzjonijiet oħra, u tiżgura li dawn jibqgħu jitħarsu.
English: The PRAC have also further considered for the feasibility and likely effectiveness of risk minimisation measures.
Maltese: Il-PRAC ikkunsidra wkoll il-fattibilità u l-effettività probabbli tal-miżuri ta' minimizzazzjoni tar-riskju.
English: • With regards to the efficacy, PRAC considered that there is no new significant information related to the approved indication.
Maltese: • Fir-rigward tal-effikaċja, il-PRAC ikkunsidra li m'hemm l-ebda informazzjoni sinifikanti ġdida relatata mal-indikazzjoni approvata.
English: In its assessment, the PRAC considered the totality of evidence which includes all newly available data since the previous referral procedures, including results from DUSs, clinical studies, meta-analyses of clinical studies, post-marketing experience, Eudravigilance data, literature review, responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations as well as stakeholders' submissions and views expressed by experts during an ad-hoc experts meeting, taking into account also the characterisation of benefits and risks concluded in the previous referral procedures.
Maltese: Fil-valutazzjoni tiegħu, il-PRAC ikkunsidra t-totalità tal-evidenza li tinkludi d-data kollha li għadha kif saret disponibbli sa mill-proċeduri ta' referenza preċedenti, inkluż riżultati minn DUSs, studji kliniċi, meta-analiżijiet ta' studji kliniċi, esperjenza ta' wara t-tqegħid fis-suq, data minn Eudravigilance, reviżjoni tal-letteratura, tweġibiet ippreżentati mid-detenturi tal-awtorizzazzjoni għat-tqegħid fuq issuq (MAHs) bil-miktub u fi spjegazzjonijiet bil-fomm kif ukoll preżentazzjonijiet tal-partijiet ikkonċernati u fehmiet espressi minn esperti waqt laqgħa tal-esperti ad-hoc, filwaqt li ġiet ikkunsidrata wkoll il-karatterizzazzjoni tal-benefiċċji u tar-riskji konklużi fil-proċeduri ta' referenza preċedenti.
English: However, this measure should be seen as part of the complete program of risk minimisation measures.
Maltese: Madankollu, din il-miżura għandha titqies bħala parti mill-programm sħiħ ta' miżuri ta' minimizzazzjoni tar-riskju.
English: In 2013, following a review of the risk of kidney injury and mortality related to hydroxyethyl starch (HES) solutions for infusion when administered in patients with sepsis or critical illness, the Pharmacovigilance and Risk Assessment Committee (PRAC) recommended risk minimisation measures such as restrictions in use of these medicinal products.
Maltese: Fl-2013, wara reviżjoni tar-riskju ta' korriment u tal-kliewi u l-mortalità relatati ma' soluzzjonijiet ta' lamtu idrossietili (HES) għall-infużjoni meta jingħataw f'pazjenti b'sepsis jew b'mard kritiku, il-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) rrakkomanda miżuri ta' minimizzazzjoni tarriskju bħal restrizzjonijiet fl-użu ta' dawn il-prodotti mediċinali.
English: A positive benefit-risk balance has been established in elective surgery and trauma patients.
Maltese: Ġie stabbilit bilanċ pożittiv bejn il-benefiċċju u r-riskju f'pazjenti kirurġiċi u ta' trawma elettivi.
English: • The PRAC reviewed all newly available data, including results from Drug Utilisation Studies (DUS), clinical studies, meta-analyses of clinical studies, post-marketing experience, Eudravigilance data, literature review, responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations, stakeholders' submissions and views expressed by experts during an ad-hoc experts meeting.
Maltese: • Il-PRAC irreveda d-data kollha li għadha kif saret disponibbli, inkluż riżultati minn Studji dwar lUżu magħmul mill-Mediċina (DUS), studji kliniċi, meta-analiżijiet ta' studji kliniċi, esperjenza ta' wara t-tqegħid fis-suq, data minn Eudravigilance, reviżjoni tal-letteratura, tweġibiet ippreżentati mid-detenturi tal-awtorizzazzjoni għat-tqegħid fuq is-suq (MAHs) bil-miktub u fi spjegazzjonijiet bil-fomm, preżentazzjonijiet tal-partijiet ikkonċernati u fehmiet espressi minn esperti waqt laqgħa tal-esperti ad-hoc.
English: • The CMDh took into consideration the revised PRAC recommendation as well as all the new elements submitted by the MAHs and the Member States regarding potential medical need and the feasibility and likely effectiveness of additional risk minimisation measures and available since the previous CMDh position adopted in January 2018.
Maltese: • Is-CMDh qies ir-rakkomandazzjoni riveduta tal-PRAC kif ukoll l-elementi ġodda kollha ppreżentati mill-MAHs u l-Istati Membri rigward il-ħtieġa medika potenzjali u l-fattibilità u leffettività probabbli ta' miżuri addizzjonali ta' minimizzazzjoni tar-riskju u disponibbli millpożizzjoni preċedenti tas-CMDh adottata f'Jannar 2018.
English: • The PRAC further acknowledged that the current clinical experience suggests that it is difficult to clearly separate patient populations where randomised clinical trials have shown serious harm from populations targeted by the approved indication.
Maltese: • Il-PRAC kompla rrikonoxxa li l-esperjenza klinika attwali tissuġġerixxi li huwa diffiċli li lpopolazzjonijiet tal-pazjent jiġu sseparati b'mod ċar fejn provi kliniċi randomizzati wrew ħsara serja minn popolazzjonijiet immirati mill-indikazzjoni approvata.
English: The PRAC adopted a recommendation on 11 January 2018 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Maltese: Il-PRAC adotta rakkomandazzjoni, fil-11 ta' Jannar 2018 li dak iż-żmien kienet ikkunsidrata mis-CMDh, skont l-Artikolu 107k tad-Direttiva 2001/83/KE.
English: • Whilst acknowledging the difficulties of continuous training, centralising such organisation and monitoring by the MAH will address the challenges raised.
Maltese: • Filwaqt li jirrikonoxxi d-diffikultajiet ta' taħriġ kontinwu, iċ-ċentralizzazzjoni ta' organizzazzjoni u monitoraġġ mill-MAH bħal dan se jindirizza l-isfidi mqajma.
English: Revised grounds for PRAC recommendation
Maltese: Reviżjoni tar-rakkomandazzjoni tal-PRAC
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 107i of Directive 2001/83/EC, for hydroxyethyl starch (HES) solution for infusion (see Annex I).
Maltese: • Il-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) ikkunsidra l-proċedura skont l-Artikolu 107i tad-Direttiva 2001/83/KE, għal soluzzjoni għall-infużjoni ta' lamtu idrossietili (HES) (ara Anness I).
English: Med 2008; 358(2):125-39 5 Myburgh J, Finder S, Bellomo R et al. Hydroxyethyl starch or saline for fluid resuscitation in intensive care.
Maltese: 5 Myburgh J, Finder S, Bellomo R et al.
English: With regards to efficacy, PRAC considered that there is no new significant information related to the approved indication.
Maltese: Fir-rigward tal-effikaċja, il-PRAC ikkunsidra li m'hemm l-ebda informazzjoni sinifikanti ġdida relatata mal-indikazzjoni approvata.
English: Having reviewed the revised PRAC recommendation7, the CMDh disagreed with the PRAC overall conclusions and grounds for recommendation.
Maltese: Wara li rreveda r-rakkomandazzjoni riveduta tal-PRAC7, is-CMDh ma qabilx mal-konklużjonijiet u rraġunijiet globali għar-rakkomandazzjoni tal-PRAC.
English: PRAC confirmed that the available information, including more recent submitted clinical data, do not change the established risk of increased mortality and renal failure related to the use of HES solutions for infusion in these patients.
Maltese: Il-PRAC ikkonferma li l-informazzjoni disponibbli, inkluż id-data klinika li ġiet ippreżentata aktar riċentement, ma tibdilx ir-riskju stabbilit ta' żieda fir-riskju ta' mortalità u insuffiċjenza tal-kliewi relatati mal-użu ta' soluzzjonijiet għall-infużjoni ta' HES f'dawn ilpazjenti.
English: In the light of the above information, the PRAC confirmed at its May 2018 plenary meeting, its previous scientific conclusions that the benefit risk of HES solutions for infusion is negative and recommended to suspend the marketing authorisations of these medicinal products.
Maltese: Fid-dawl tal-informazzjoni ta' hawn fuq, il-PRAC ikkonferma fil-laqgħa plenarja tiegħu ta' Mejju 2018 ilkonklużjonijiet xjentifiċi preċedenti tiegħu li r-riskju tal-benefiċċju tas-soluzzjonijiet għall-infużjoni ta' HES huwa negattiv u rrakkomandat li jiġu sospiżi l-awtorizzazzjonijiet għat-tqegħid fis-suq ta' dawn ilprodotti mediċinali.
English: In view of the overall exposure to HES solutions for infusion in the EU, estimated to about 1.5 to 2 million patients per year since 2014 and the reported extent of usage in patients with sepsis from the two DUSs, the estimated level of continued usage in populations where serious harm has been demonstrated raises important public health concerns, including a potentially increased mortality.
Maltese: Fid-dawl tal-esponiment globali għal soluzzjonijiet għall-infużjoni ta' HES fl-UE, li huwa stmat għal madwar 1.5 sa 2 miljun pazjenti fis-sena mill-2014 u fid-dawl tal-livell ta' użu rrapportat f'pazjenti b'sepsis miż-żewġ DUSs, il-livell stmat ta' użu kontinwu f'popolazzjonijiet fejn intweriet ħsara serja, qajjem tħassib importanti dwar is-saħħa pubblika, inkluż żieda potenzjali fil-mortalità.
English: It is proposed to mention explicitly in the new warnings ‘renal impairment' in addition to ‘sepsis' and ‘critically ill patients'; this would add further emphasis on this specific critically ill patients.
Maltese: Huwa propost li jissemma espliċitament “fl-indeboliment tal-kliewi” ta' twissijiet ġodda flimkien ma' “sepsis” u “pazjenti morda b'mod kritiku”; dan iżid aktar enfasi fuq dawn il-pazjenti speċifiċi kritikament morda.
English: On 17 October 2017, Sweden triggered an urgent Union procedure under Article 107i of Directive 2001/83/EC, and requested the PRAC to assess the impact of the above non-adherence to the product information on the benefit-risk balance of hydroxyethyl starch (HES) solutions for infusion and issue a recommendation on whether the marketing authorisations of these products should be maintained, varied, suspended or revoked.
Maltese: Fis-17 ta' Ottubru 2017, l-Iżvezja tat bidu għal proċedura skont l-Artikolu 107i tadDirettiva 2001/83/KE, u talbet lill-PRAC sabiex jivvaluta l-impatt tan-nuqqas ta' osservanza talinformazzjoni t'hawn fuq dwar il-bilanċ bejn il-benefiċċju u r-riskju ta' soluzzjonijiet għall-infużjoni ta' lamtu idrossietili (HES) u biex joħroġ rakkomandazzjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq ta' dawn il-prodotti għandhomx jinżammu, jiġu varjati, sospiżi jew revokati.
English: Grounds for differences with the PRAC recommendation
Maltese: Ħafna mill-argumenti
English: Overall non-adherence to the revised product information was reported to be high, and PRAC was particularly concerned that approximately 9% of patients exposed to HES solutions for infusion were critically ill, approximately 5-8% of patients had renal impairment and approximately 3-4% of patients had sepsis.
Maltese: B'mod globali, in-nuqqas ta' aderenza għall-informazzjoni reveduta dwar il-prodott kien irrapportat bħala għoli, u lPRAC kien partikolarment imħasseb li madwar 9 % tal-pazjenti esposti għal soluzzjonijiet għallinfużjoni ta' HES kienu morda serjament, madwar 5-8 % tal-pazjenti kellhom indeboliment tal-kliewi u madwar 3-4 % tal-pazjenti kellhom sepsis.
English: The details of the controlled access program, the modalities of its implementation and the final training materials, including communication media and distribution modalities should be agreed with the National Competent Authorities.
Maltese: Id-dettalji tal-programm ta' aċċess ikkontrollat, il-modalitajiet tal-implimentazzjoni tiegħu u l-materjali ta' taħriġ finali, inklużi mezzi ta' komunikazzjoni u modalitajiet ta' distribuzzjoni għandhom jiġu miftiehma mal-Awtoritajiet Nazzjonali Kompetenti.
English: The training materials should be distributed to all relevant HCPs intended to prescribe/administer HES solutions for infusion (e.g. anaesthiologists, intensive care physicians, nurses…).
Maltese: Il-materjali li jintużaw fit-taħriġ għandhom jitqassmu lill-HCPs rilevanti kollha maħsuba biex jippreskrivu/jamministraw soluzzjonijiet għall-infużjoni ta' HES (eż. anestjologi, tobba tal-kura intensiva, infermiera ...).
English: Having reviewed the PRAC recommendation6, the CMDh agreed by a majority on 24 January 2018 with the PRAC overall conclusions and grounds for recommendation.
Maltese: Wara li rreveda r-rakkomandazzjoni tal-PRAC6, is-CMDh qabel b'maġġoranza, fl-24 ta' Jannar 2018, mal-konklużjonijiet u r-raġunijiet globali għar-rakkomandazzjoni tal-PRAC.
English: Amongst other data related to safety, the PRAC reviewed the results from two separate DUSs conducted to assess the effectiveness of the risk minimisation measures imposed as an outcome of the 2013 referral, and concluded that these studies despite a potential limitation of possible misclassification, are representative of the clinical usage in the European Union and that key results are reliable.
Maltese: Fost data oħra relatata mas-sigurtà, il-PRAC irreveda r-riżultati minn żewġ DUSs separati li saru biex tiġi vvalutata l-effettività tal-miżuri tal-minimizzazzjoni tar-riskju imposti bħala eżitu tar-referenza tal2013, u kkonkluda li minkejja limitazzjoni potenzjali ta' nuqqas ta' klassifikazzjoni possibbli, dawn listudji huma rappreżentattivi tal-użu kliniku fl-Unjoni Ewropea u li r-riżultati ewlenin huma affidabbli.
English: The PRAC considered further risk minimisation measures which could potentially sufficiently minimise this exposure, including restricted access / distribution to hospitals and physicians, changes to the product information, direct health care professional communication, educational materials to be distributed in cooperation with some learned societies, warning on the primary container of the products, medication form and follow-up questionnaire.
Maltese: Il-PRAC ikkunsidra miżuri oħra ta' minimizzazzjoni tar-riskju li jistgħu jnaqqsu b'mod suffiċjenti dan lesponiment, inkluż aċċess ristrett / distribuzzjoni għal sptarijiet u tobba, bidliet fl-informazzjoni dwar il-prodott, komunikazzjoni diretta tal-kura tas-saħħa diretta, materjali edukattivi li għandhom jitqassmu f'kooperazzjoni ma' xi soċjetajiet mgħallma, twissija fuq il-kontenitur primarju tal-prodotti, il-formola tal-medikazzjoni u l-kwestjonarju ta' segwitu.
English: This includes recordings of trainings and accreditation.
Maltese: Dan jinkludi reġistrazzjonijiet ta' taħriġ u akkreditazzjoni.
English: A medication form to be filled before administration would also raise feasibility issues in an emergency setting.
Maltese: Formola ta' medikazzjoni għandha timtela qabel l-amministrazzjoni tqajjem ukoll kwistjonijiet ta' vijabilità f'ambjent ta' emerġenza.
English: These include drug utilisation data from 11 EU Member States.
Maltese: Dawn jinkludu data dwar l-użu magħmul millmediċina minn 11-il Stat Membru tal-UE.
English: The PRAC considered that despite arguments raised by some Member States, the potential for unmet medical need is not established.
Maltese: Il-PRAC ikkunsidra li minkejja l-argumenti mqajma minn xi Stati Membri, il-potenzjal għal ħtieġa medika mhux sodisfatta mhuwiex stabbilit.
English: The CMDh took also into consideration the responses to the questions raised by the European Commission and the elements collected by the PRAC, as well as the information provided by the MAH during the oral explanations held on 28 May 2018 and 25 June 2018.
Maltese: Is-CMDh qies wkoll it-tweġibiet għall-mistoqsijiet imqajma mill-Kummissjoni Ewropea u l-elementi miġbura mill-PRAC, kif ukoll l-informazzjoni pprovduta mill-MAH matul l-ispjegazzjonijiet orali li saru fit-28 ta' Mejju 2018 u l25 ta' Ġunju 2018.
English: These reviews were triggered by the results from large randomised clinical studies3,4,5 which showed an increased risk of mortality in patients with sepsis and an increased risk of kidney injury requiring dialysis in critically ill patients following treatment with HES solutions for infusion.
Maltese: Dawn irreviżjonijiet ġew skattati mir-riżultati minn studji kliniċi randomizzati kbar3,4,5 li wrew riskju miżjud ta' mortalità f'pazjenti b'sepsis u riskju miżjud ta' ħsara fil-kliewi li tkun teħtieġ dijaliżi f'pazjenti morda serjament wara kura b'soluzzjonijiet għall-infużjoni ta' HES.
English: Drug Utilisation Study (DUS)
Maltese: Studju dwar l-Użu magħmul mill-Mediċina (DUS)
English: In view of the insight that the CMDh has on the national healthcare systems, it agreed that the following additional risk minimisation measures are feasible and likely to be effective to minimise the risk of using HES solutions for infusion in contraindicated populations: the inclusion of an emphasised warning on the SmPC, PL, primary and secondary packaging, the circulation of a targeted DHPC and the implementation of a controlled access program.
Maltese: Fid-dawl tal-għarfien li s-CMDh għandha fuq is-sistemi tal-kura tas-saħħa nazzjonali, qablet li l-miżuri ta' minimizzazzjoni tar-riskju addizzjonali li ġejjin huma fattibbli u x'aktarx li jkunu effettivi biex jimminimizzaw ir-riskju li jużaw soluzzjonijiet għall-infużjoni ta' HES f'popolazzjonijiet kontroindikati: l-inklużjoni ta' twissija enfasizzata fuq is-SmPC, PL, l-imballaġġ primarju u sekondarju, iċ-ċirkolazzjoni ta' DHPC immirat u l-implimentazzjoni ta' programm ta' aċċess ikkontrollat.
English: • The PRAC also noted the overall exposure to HES solutions for infusion in the EU, estimated to about 1.5 to 2 million patients per year since 2014.
Maltese: • Il-PRAC innota wkoll l-esponiment globali għal soluzzjonijiet għall-infużjoni ta' HES fl-UE, li huwa stmat għal madwar 1.5 sa 2 miljun pazjent fis-sena mill-2014.
English: The protocol should also include a measure of the primary outcomes at baseline.
Maltese: Il-protokoll għandu jinkludi wkoll miżura tar-riżultati primarji fillinja bażi.
English: The PRAC has considered all elements expressed in relation to the impact of a suspension of the marketing authorisation for HES solutions for infusion on a potential unmet medical need at national level, including comments submitted by the MAHs in writing and at oral explanations, responses from Member States and other stakeholders' views.
Maltese: Il-PRAC ikkunsidra l-elementi kollha espressi fir-rigward tal-impatt ta' sospensjoni tal-awtorizzazzjoni għat-tqegħid fis-suq għal soluzzjonijiet għall-infużjoni ta' HES fuq ħtieġa medika potenzjali mhux sodisfatta f'livell nazzjonali, inklużi kummenti sottomessi mill-MAHs bil-miktub u waqt spjegazzjonijiet orali, risposti minn Stati Membri u l-opinjonijiet l-oħrajn tal-partijiet interessati.
English: • Impact on the clinical practice of potential suspension of MA for HES solutions for infusion
Maltese: • Impatt fuq il-prattika klinika ta' sospensjoni potenzjali ta' MA għal soluzzjonijiet għall-infużjoni ta' HES
English: The medication form/checklists would also raise feasibility issues in an emergency setting.
Maltese: Il-formola ta' medikazzjoni/listi ta' kontroll iqajmu wkoll kwistjonijiet ta' affidabbiltà f'ambjent ta' emerġenza.
English: • Whilst patients eligible to treatment with HES solutions for infusion cannot be restricted to specific hospitals or hospital departments, it is possible to identify within a hospital/centre the relevant HCPs who would be prescribing/administrating HES solutions for infusion.
Maltese: • Filwaqt li pazjenti eliġibbli għal trattament b'soluzzjonijiet għall-infużjoni ta' HES ma jistgħux ikunu ristretti għal sptarijiet jew dipartimenti tal-isptar speċifiċi, huwa possibbli li jiġu identifikati fi sptar/ċentru l-HCPs rilevanti li jkunu qed jippreskrivu/jamministraw soluzzjonijiet għall-infużjoni ta' HES.
English: The medication form/checklists would also raise feasibility issues in an emergency setting, and implementation of a restricted access/distribution program is unlikely to be feasible and sufficiently effective across EU Member States considering the particular type of distribution and usage of HES solutions for infusion and some national limitations.
Maltese: Il-formola ta' medikazzjoni/listi ta' kontroll tqajjem ukoll kwistjonijiet ta' vijabilità f'ambjent ta' emerġenza, u l-implimentazzjoni ta' programm ta' aċċess/distribuzzjoni ristrett x'aktarx li ma tkunx vijabbli u effettiva biżżejjed fl-Istati Membri kollha tal-UE meta jitqies it-tip partikolari ta' distribuzzjoni u użu ta' soluzzjonijiet għall-infużjoni ta' HES u xi limitazzjonijiet nazzjonali.
English: Progress on the ongoing DUS shall be reported within the upcoming PSUR.
Maltese: Il-progress fuq id-DUS li għaddej għandu jiġi rrappurtat fil-PSUR li jmiss.