FrancophonIA/ELRC3.0 huggingface dataset:
English: • the CVMP concluded that the benefit-risk assessment for veterinary medicinal products containing paromomycin to be administered parenterally to pigs is negative because there were inadequate data to support efficacy of these veterinary medicinal products for the proposed indications at the recommended treatment dose and that this deficiency poses a risk of ineffective treatment and antimicrobial resistance development; the CVMP has recommended the suspension of the marketing authorisations for veterinary medicinal products containing paromomycin to be administered parenterally to pigs as referred in Annex I. The conditions to lift the suspension of the marketing authorisations are set out in Annex III.
Maltese: • is-CVMP ikkonkluda li l-valutazzjoni benefiċċji/riskji għal prodotti mediċinali veterinarji li fihom paromomycin li jingħataw b'mod parenterali lill-ħnieżer hija negattiva minħabba li kien hemm data inadegwata biex tappoġġja l-effikaċja ta' dawn il-prodotti mediċinali veterinarji għallindikazzjonijiet proposti bid-doża ta' trattament rakkomandata u li dan in-nuqqas joħloq riskju ta' trattament ineffettiv u ta' żvilupp ta' reżistenza antimikrobika; is-CVMP irrakkomanda s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti mediċinali veterinarji li fihom paromomycin li jingħataw b'mod parenterali lill-ħnieżer kif imsemmi flAnness I.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamla farmaċewtika, qawwa tal-prodotti mediċinali veterinarji, speċi ta' annimali, detenturi talawtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: • To provide adequate clinical data in support of an indication against colibacillosis at the recommended dose and duration of treatment.
Maltese: • Li jipprovdu data klinika adegwata li tappoġġja indikazzjoni kontra l-kolibaċillożi bid-doża u ddurata tat-trattament rakkomandata.
English: In order to justify efficacy of the product, susceptibility data were provided for E. coli and A. pleuropneumoniae and a pharmacokinetics/pharmacodynamics (PK/PD) analysis was performed.
Maltese: Sabiex tiġi ġġustifikata l-effikaċja tal-prodott, ġiet ipprovduta data dwar is-suxxettibbiltà għal E. coli u għal A. pleuropneumoniae u saret analiżi tal-farmakokinetika/farmakodinamika (PK/PD).
English: For antimicrobials like paromomycin, whose efficacy is concentration-dependent, high plasma concentration levels relative to the MIC of the pathogen (Cmax/MIC ratio, also known as the inhibitory quotient or IQ) are a major determinant of clinical efficacy; a Cmax/MIC ratio > 8-10 is suggested to achieve optimal efficacy.
Maltese: Għal antimikrobiċi bħal paromomycin, li l-effikaċja tagħhom tiddependi fuq il-konċentrazzjoni, livelli għoljin ta' konċentrazzjoni tal-plażma relattivi għall-MIC tal-patoġenu (il-proporzjon Cmax/MIC, magħruf ukoll bħala l-kwozjent inibitorju jew IQ) huma determinant ewlieni tal-effikaċja klinika; huwa ssuġġerit proporzjon ta' Cmax/MIC ta' > 8-10 biex tinkiseb l-aħjar effikaċja.
English: In the case of E. coli, the PK/PD analysis was only favourable for strains with MICs equal to or below 4.44 µg/ml.
Maltese: Fil-każ ta' E. coli, l-analiżi PK/PD kienet favorevoli biss għal razez b'MICs daqs jew inqas minn 4.44 µg/ml.
English: Hence, the veterinary medicinal product could be expected to be effective against E. coli as shown by the sensitivity results of a recent study, where 76% of the strains would be sensitive.
Maltese: Għalhekk, il-prodott mediċinali veterinarju jista' jkun mistenni li jkun effettiv kontra E. coli kif muri mir-riżultati tas-sensittività ta' studju reċenti, fejn 76 % tar-razez ikunu sensittivi.
English: • To provide adequate clinical data (including GCP, randomised, blinded field study) in support of the treatment of pleuropneumonia caused by Actinobacillus pleuropneumoniae at the recommended dose and duration of treatment.
Maltese: • Li jipprovdu data klinika adegwata (inkluż studju fuq il-post PKT, randomizzat, blinded) li jappoġġja t-trattament ta' plewropulmonite kkawżata minn Actinobacillus pleuropneumoniae bid-doża u d-durata tat-trattament rakkomandata.
English: Huvepharma NV
Maltese: Qawwa Għamla farmaċewtika
English: Paromomycin has broad spectrum activity against numerous Gram-positive and Gram-negative bacteria and acts in a concentrationdependent manner.
Maltese: Paromomycin għandu attività wiesgħa ta' spettru kontra bosta batterji Gram-pożittivi u Gram-negattivi u jaġixxi b'mod li jiddependi fuq il-konċentrazzjoni.
English: The reference product is authorised in Belgium since 1985.
Maltese: Il-prodott ta' referenza ilu awtorizzat fil-Belġju mill-1985.
English: One of the marketing authorisation holders proposed a withdrawal time of 16 days based on a linear regression with kidney as limiting tissue, and 16 days with muscle of injection site by using the ‘alternative' method, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95).
Maltese: Wieħed mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq ippropona żmien ta' rtirar ta' 16-il jum ibbażat fuq regressjoni lineari bil-kliewi bħala t-tessut ta' limitazzjoni, u 16-il jum bil-muskolu tas-sit tal-injezzjoni billi jintuża l-metodu “alternattiv”, f'konformità man-nota tas-CVMP għal gwida dwar lapproċċ lejn l-armonizzazzjoni tal-perjodi ta' tiżmim (EMEA/CVMP/036/95).
English: The currently authorised indications are unspecific and no specific pathogens are mentioned i.e. for the treatment of bacterial infections caused by pathogens which are susceptible to paromomycin or for bacterial infections of the respiratory tract, uro-genital tract, mastitis, enteritis, abscess, wounds, canine leishmaniosis and surgery.
Maltese: L-indikazzjonijiet awtorizzati attwalment mhumiex speċifiċi u ma jissemma l-ebda patoġenu speċifiku, jiġifieri għat-trattament ta' infezzjonijiet batteriċi kkawżati mill-patoġeni li huma suxxettibbli għal paromomycin jew għal infezzjonijiet batteriċi tal-apparat respiratorju, l-apparat uroġenitali, mastite, enterite, axxessi, feriti, lexmanjożi tal-klieb u kirurġija.
English: The same marketing authorisation holder provided data in order to justify the use of ‘Gabbrovet solution injectable' in pigs at a dose of 14 mg paromomycin base/kg bodyweight for 5 consecutive days.
Maltese: L-istess detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ipprovda data sabiex tiġġustifika l-użu ta' “Gabbrovet soluzzjoni injettabbli” fil-ħnieżer b'doża ta' 14 mg paromomycin bażi/kg piż tal-ġisem għal 5 ijiem konsekuttivi.
English: This already poor result is in addition likely to overestimate the efficacy of paromomycin at the recommended dose since the % binding of paromomycin to plasma proteins was not determined, which would reduce the portion of paromomycin in plasma able to work against A. pleuropneumoniae.
Maltese: Dan ir-riżultat diġà dgħajjef huwa barra minn hekk probabbli li jissopravaluta l-effikaċja ta' paromomycin fid-doża rakkomandata peress li l-% ta' rbit ta' paromomycin mal-proteini tal-plażma ma ġiex determinat, li jnaqqas il-proporzjon ta' paromomycin filplażma li jista' jaħdem kontra A. pleuropneumoniae.
English: For kidney, a withdrawal time rounded to 16 days was determined based on linear regression using the ‘statistical' method, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95).
Maltese: Għall-kliewi, ġie determinat żmien ta' rtirar imqarreb għal 16-il jum abbażi ta' rigressjoni lineari permezz tal-metodu “statistiku”, f'konformità man-nota tas-CVMP għal gwida dwar l-approċċ lejn larmonizzazzjoni tal-perjodi ta' tiżmim (EMEA/CVMP/036/95).
English: Risk management or mitigation measures
Maltese: 3. Valutazzjoni benefiċċji/riskji
English: During the aforementioned decentralised procedure, it has been noted that there are different approved indications, posology and withdrawal periods for veterinary medicinal products containing paromomycin to be administered parenterally to pigs across the European Union (EU).
Maltese: Matul il-proċedura deċentralizzata msemmija hawn fuq, ġie nnutat li hemm indikazzjonijiet, pożoloġija u perjodi ta' rtirar differenti approvati għal prodotti mediċinali veterinarji li fihom paromomycin li jingħataw b'mod parenterali lill-ħnieżer madwar l-Unjoni Ewropea (UE).
English: Samples of the target tissues were analysed by HPLC method coupled with MS/MS detection.
Maltese: Kampjuni tat-tessuti fil-mira ġew analizzati bil-metodu HPLC flimkien ma' detezzjoni MS/MS.
English: The residue depletion study was performed in pigs with the intramuscular administration of the maximum recommended dose of 14 mg paromomycin/kg bodyweight/day for 5 consecutive days.
Maltese: L-istudju dwar it-tnaqqis tar-residwi sar fil-ħnieżer b'għoti ġol-muskoli tad-doża massima rakkomandata ta' 14 mg paromomycin/kg piż tal-ġisem/jum għal 5 ijiem konsekuttivi.
English: Belgium Huvepharma NV Uitbreidingstraat 80
Maltese: Il-Ġermanja Huvepharma NV Uitbreidingstraat 80
English: Therefore, the indication against colibacillosis based on an overestimated success from a theoretical modelling, against E. coli strictly located in plasma, for an unjustified duration of treatment and not confirmed by clinical data, is not acceptable.
Maltese: Għalhekk, l-indikazzjoni kontra l-kolibaċillożi bbażata fuq suċċess sopravvalutat minn immudellar teoretiku, kontra E. coli li jinstabu strettament fil-plażma, għal durata ta' trattament mhux iġġustifikata u mhux ikkonfermata minn data klinika, mhijiex aċċettabbli.
English: Due to the deficiencies noted in the study, a withdrawal period cannot be covered by any safety margin.
Maltese: Minħabba n-nuqqasijiet li nstabu fl-istudju, perjodu ta' tiżmim ma jistax ikun kopert bi kwalunkwe marġini ta' sigurtà.
English: Overall summary of the scientific evaluation of Veterinary medicinal products containing paromomycin to be administered parenterally to pigs (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika tal-prodotti mediċinali Veterinarji li fihom paromomycin li jingħataw b'mod parenterali lill-ħnieżer (ara Anness I)
English: • the CVMP considered that the use of veterinary medicinal products containing paromomycin to be administered parenterally to pigs is not supported by pre-clinical, clinical and residue depletion data and the currently recommended indications, dosing regimens and withdrawal period could pose a potential risk to animal and human health;
Maltese: • is-CVMP ikkunsidra li l-użu ta' prodotti mediċinali veterinarji li fihom paromomycin li jingħataw b'mod parenterali lill-ħnieżer mhuwiex appoġġat minn data preklinika, klinika u dwar it-tnaqqis tarresidwi u li l-indikazzjonijiet, ir-reġims tad-dożaġġ u l-perjodu ta' tiżmim li huma rakkomandati attwalment jistgħu joħolqu riskju potenzjali għas-saħħa tal-annimali u tal-bniedem;
English: The statistical evaluation to establish withdrawal period was carried out following the CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)1.
Maltese: L-evalwazzjoni statistika biex jiġi stabbilit il-perjodu ta' tiżmim saret wara n-nota tas-CVMP għal gwida dwar l-approċċ lejn l-armonizzazzjoni tal-perjodi ta' tiżmim (EMEA/CVMP/036/95)1.
English: For injection site, a rounded withdrawal period of 16 days was calculated using the ‘alternative' method, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95).
Maltese: Għas-sit tal-injezzjoni, ġie kkalkulat perjodu ta' tiżmim imqarreb għal 16-il jum permezz tal-metodu “alternattiv”, f'konformità man-nota tas-CVMP għal gwida dwar l-approċċ lejn l-armonizzazzjoni talperjodi ta' tiżmim (EMEA/CVMP/036/95).
English: Evaluation and conclusions on the benefit-risk balance Therefore, the Committee considers that in the absence of adequate pre-clinical, clinical and residue depletion data and because the use of these medicinal products could pose a potential risk to animal and human health, the benefit-risk balance for the concerned veterinary medicinal products containing paromomycin to be administered parenterally to pigs is not favourable.
Maltese: Evalwazzjoni u konklużjonijiet dwar il-bilanċ bejn il-benefiċċju u r-riskju Għalhekk, il-Kumitat iqis li fin-nuqqas ta' data adegwata preklinika, klinika u dwar it-tnaqqis tarresidwi u minħabba li l-użu ta' dawn il-prodotti mediċinali jista' jkun ta' riskju potenzjali għas-saħħa tal-annimali u tal-bniedem, il-bilanċ bejn il-benefiċċju u r-riskju għall-prodotti mediċinali veterinarji kkonċernati li fihom paromomycin li jingħataw b'mod parenterali lill-ħnieżer mhuwiex favorevoli.
English: The most relevant tissues for the presence of paromomycin residue were muscle at the injection site and kidney.
Maltese: L-aktar tessuti rilevanti għall-preżenza ta' residwi ta' paromomycin kienu l-muskolu fis-sit tal-injezzjoni u l-kliewi.
English: Denmark
Maltese: Antwerpen
English: The marketing authorisation holder also considered that the veterinary medicinal product could be used to treat Mastitis-Metritis-Agalactia (MMA) syndrome associated with E. coli, but acknowledged that further data are needed to assess the correct dose regimen in adult animals.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ikkunsidra wkoll li l-prodott mediċinali veterinarju jista' jintuża biex jikkura sindrome ta' Mastite-Metrite-Agalattja (MMA) assoċjat ma' E. coli,, iżda rrikonoxxa li hija meħtieġa aktar data biex jiġi vvalutat ir-reġim korrett tad-doża f'annimali adulti.
English: Slovak Republic Huvepharma NV Uitbreidingstraat 80
Maltese: Id-Danimarka Huvepharma NV Uitbreidingstraat 80
English: 28 June 2012
Maltese: 28 ta' Ġunju 2012
English: EMA/264710/2012 Rev.1 EMEA/H/A-29/001326 EMEA/H/A-29/001327
Maltese: EMA/264710/2012 Rev.1 EMEA/H/A-29/001326
English: Questions and answers on Flutiform and Iffeza (fluticasone propionate/formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension)
Maltese: Mistoqsijiet u tweġibiet dwar Flutiform u Iffeza (fluticasone propionate/formoterol fumarate, 50/5, 125/5 u 250/10 mikrogrammi, inalazzjoni taħt pressjoni, sospensjoni)
English: Questions and answers on Flutiform and Iffeza (fluticasone propionate/formoterol fumarate, 50/5, 125/5 and 250/10 micrograms, pressurised inhalation, suspension) EMA/550822/2012
Maltese: Mistoqsijiet u tweġibiet dwar Flutiform u Iffeza (fluticasone propionate/formoterol fumarate, 50/5, 125/5 u 250/10 mikrogrammi, inalazzjoni taħt pressjoni, sospensjoni) EMA/264710/2012
English: What are Flutiform and Iffeza?
Maltese: X'inhuma Flutiform u Iffeza?
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the UK) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Luxembourg, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia and Sweden).
Maltese: Din hija proċedura fejn Stat Membru (l-‘Istat Membru ta' referenza', f'dan ilkaż ir-Renju Unit) jevalwa mediċina bl-għan li jagħti awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħrajn (l-‘Istati Membri kkonċernati', f'dan il-każ l-Awstrija, ilBelġju, il-Bulgarija, Ċipru, ir-Repubblika Ċeka, id-Danimarka, il-Finlandja, Franza, il-Ġermanja, lIslanda, l-Irlanda, l-Italja, il-Lussemburgu, il-Pajjiżi l-Baxxi, in-Norveġja, il-Polonja, il-Portugall, irRumanija, is-Slovakkja u l-Isvezja).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Flutiform and Iffeza outweigh the risks, and that the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Luxembourg, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia and Sweden.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) talAġenzija kkonkluda li l-benefiċċji ta' Flutiform u Iffeza huma akbar mir-riskji tagħhom, u li lawtorizzazzjoni għat-tqegħid fis-suq tista' tingħata fir-Renju Unit u f'dawn l-Istati Membri tal-UE li ġejjin: l-Awstrija, il-Belġju, il-Bulgarija, Ċipru, ir-Repubblika Ċeka, id-Danimarka, il-Finlandja, Franza, il-Ġermanja, l-Islanda, l-Irlanda, l-Italja, il-Lussemburgu, il-Pajjiżi l-Baxxi, in-Norveġja, il-Polonja, ilPortugall, ir-Rumanija, is-Slovakkja u l-Isvezja.
English: Flutiform will also be marketed as Flofera and Flutiformo.
Maltese: Flutiform ser ikun mibjugħ ukoll bħala Flofera u Flutiformo.
English: Why were Flutiform and Iffeza reviewed?
Maltese: Għalxiex ġew riveduti Flutiform u Iffeza?
English: Napp Pharmaceuticals Ltd submitted marketing authorisation applications for Flutiform and Iffeza and associated names to the UK medicines regulatory agency under the decentralised procedure.
Maltese: Napp Pharmaceuticals Ltd issottomettiet applikazzjonijiet għall-awtorizzazzjoni għat-tqegħid fis-suq għal Flutiform u Iffeza u ismijiet assoċjati lill-aġenzija regolatorja tal-mediċini tar-Renju Unit skont ilproċedura deċentralizzata.
English: Fluticasone propionate is an inhaled corticosteroid with high local anti-inflammatory activity and has been shown to reduce symptoms of asthma and reduce exacerbations of asthma.
Maltese: Fluticasone propionate huwa kortikosterojde inalat b'attività anti-infjammatorja lokali għolja u ntwera li jnaqqas is-sintomi tal-ażma u jnaqqas l-aggravar tal-ażma.
English: Flutiform and Iffeza are asthma medicines containing two active substances, fluticasone propionate and formoterol fumarate.
Maltese: Flutiform u Iffeza huma mediċini kontra l-ażma li fihom żewġ sustanzi attivi, fluticasone propionate u formoterol fumarate.
English: The selective long-acting beta 2 agonist formoterol fumarate exerts an effect on beta 2 receptors on the smooth muscle in the lung to produce relaxation of the airways and bronchodilatation.
Maltese: L-agonist tal-beta 2 selettiv u li jaġixxi fit-tul formoterol fumarate jaffettwa lir-riċetturi beta 2 fuq ilmuskolu lixx fil-pulmun sabiex jipproduċi rilassament tal-passaġġi tal-arja u dilatazzjoni tal-bronki.
English: On 19 April 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicines Flutiform and Iffeza and associated names.
Maltese: Fid-19 ta' April 2012, l-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' ftehim fost l-Istati Membri tal-Unjoni Ewropea (UE) rigward l-awtorizzazzjoni tal-mediċini Flutiform u Iffeza u ismijiet assoċjati.
English: The grounds for the referral were concerns raised by The Netherlands over data showing that the levels of fluticasone propionate in the blood following dosing with Flutiform and Iffeza are lower than when fluticasone propionate is given alone, which may indicate a lower amount of fluticasone propionate being deposited in the lungs.
Maltese: Ir-raġunijiet għar-referenza kienu tħassib imqajjem mill-Pajjiżi l-Baxxi dwar dejta li turi li l-livelli ta' fluticasone propionate fid-demm wara doża ta' Flutiform u Iffeza huma aktar baxxi minn meta fluticasone propionate jingħata waħdu, li jista' jindika ammont aktar baxx ta' fluticasone propionate iddepożitat fil-pulmuni.
English: However, the Member States were not able to reach an agreement and the UK referred the matter to the CHMP for arbitration on 22 December 2011.
Maltese: Madankollu, l-Istati Membri ma setgħux jaslu għal ftehim u r-Renju Unit irrefera l-kwistjoni lis-CHMP għall-arbitraġġ fit-22 ta' Diċembru 2011.
English: They are to be used for the treatment of asthma in situations where the combination of an inhaled corticosteroid (such as fluticasone propionate) and a long-acting beta 2 agonist (such as formoterol fumarate) is appropriate.
Maltese: Dawn għandhom jintużaw għall-kura tal-ażma f'sitwazzjonijiet fejn tkun xierqa lkombinazzjoni ta' kortikosterojde inalat (bħal fluticasone propionate) u agonist tal-beta 2 li jaġixxi fittul (bħal formoterol fumarate).
English: Therefore, the Committee concluded that the benefits of Flutiform and Iffeza outweigh the risks and that marketing authorisation should be granted in all concerned Member States.
Maltese: Għaldaqstant, il-Kumitat ikkonkluda li l-benefiċċji ta' Flutiform u Iffeza huma akbar mir-riskji tagħhom u li għandha tingħata awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri kollha kkonċernati.
English: • the results from the DUSs
Maltese: • ir-riżultati mid-DUSs
English: • the new additional risk minimisation measures.
Maltese: • il-miżuri l-ġodda ta' minimizzazzjoni tar-riskju addizzjonali.
English: As a consequence, the MAH shall be responsible of: - delivering the training to all relevant HCPs prescribing / administering HES solutions for infusion through agreed training material.
Maltese: - li jagħti t-taħriġ lill-professjonisti tal-kura medika (HCPs) rilevanti kollha li jippreskrivu / jamministraw soluzzjonijiet għall-infużjoni ta' HES permezz ta' materjal ta' taħriġ miftiehem.
English: Each MAH of HES solutions for infusion shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures implemented as an outcome of this referral procedure.
Maltese: Kull MAH ta' soluzzjonijiet għall-infużjoni ta' HES għandu jwettaq studju dwar l-użu magħmul mill-mediċina biex jevalwa l-effettività tal-miżuri ta' minimizzazzjoni tar-riskju implimentati bħala riżultat ta' din il-proċedura ta' referenza.
English: • a reminder of the indication, dose, duration of treatment and contraindications and the need to comply with the product information
Maltese: • tfakkira tal-indikazzjoni, id-doża, it-tul tat-trattament u kontra-indikazzjonijiet u l-ħtieġa li jkun hemm konformità mal-informazzjoni dwar il-prodott
English: The MAH shall implement a controlled access program to ensure that HES solutions for infusion are only delivered to accredited hospitals / centres where healthcare professionals expected to prescribe / administer these medicinal products have been trained on their appropriate use.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jimplimenta programm ta' aċċess ikkontrollat biex jiżgura li ssoluzzjonijiet għall-infużjoni ta' HES jitwasslu biss fi sptarijiet / ċentri akkreditati fejn professjonisti fil-kura medika mistennija li jippreskrivu / jamministraw dawn il-prodotti mediċinali jkunu ġew imħarrġa fuq l-użu xieraq tagħhom.
English: The MAH should submit and agree with the National Competent Authorities: - the details of the controlled access program and the modalities of its implementation - the final training materials, including communication media and distribution modalities.
Maltese: - il-materjali tat-taħriġ finali, inklużi l-mezz tal-komunikazzjoni u lmodalitajiet ta' distribuzzjoni.
English: Protocol to be submitted for assessment by the PRAC:
Maltese: Protokoll li għandu jiġi sottomess għall-valutazzjoni mill-PRAC:
English: These measures should be submitted with a risk management plan (RMP):
Maltese: Dawn il-miżuri għandhom jiġu sottomessi ma' pjan ta' ġestjoni tarriskji (RMP):
English: The training should be repeated on regular basis.
Maltese: It-taħriġ għandu jiġi ripetut fuq bażi regolari.
English: • the risks related to the use of HES solutions for infusion outside the terms of the MA
Maltese: • ir-riskji relatati mal-użu ta' soluzzjonijiet għall-infużjoni ta' HES barra mit-termini tal-MA
English: - managing the accreditation system - ensuring HES solutions for infusion are only delivered to accredited hospital/centres, i.e where all relevant HCPs have been trained.
Maltese: - l-iżgurar li soluzzjonijiet għall-infużjoni ta' HES jitwasslu biss fi sptar / ċentri akkreditati, jiġifieri fejn l-HCPs rilevanti kollha jkunu ġew imħarrġa.