FrancophonIA/ELRC3.0 huggingface dataset:
English: In the study from Trckova et al. (2015)5, clinical observation of weaned piglets challenged with enterotoxic E. coli demonstrated a lower diarrhoea score and diarrhoea incidence in the treated animals (fed with a diet containing 2500 ppm zinc oxide in feed) than in the control animals (untreated pigs).
Maltese: (2015)5, osservazzjoni klinika ta' qżieqeż miftuma kkontestata b'E. coli enterotossika wriet punteġġ ta' dijarea u inċidenza ta' dijarea aktar baxxi fl-annimali kkurati (mgħallfin b'dieta li fiha 2500 ppm ossidu taż-żingu fl-għalf) milli fl-annimali ta' kontroll (ħnieżer mhux ikkurati).
English: Staffordshire
Maltese: L-Awstrija
English: Recommended duration of administration The available information supports the duration of 12 to 14 days for prevention of post-weaning diarrhoea in piglets.
Maltese: L-informazzjoni disponibbli tappoġġja d-durata ta' 12 sa 14-il jum għall-prevenzzjoni ta' dijarea wara lftim fil-qżieqeż.
English: The marketing authorisation holder also argues the lack of justification for rejecting risk mitigation measures proposed during the procedure under Article 33(4) of Directive 2001/82 for Gutal (EMEA/V/A/108).
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq jargumenta wkoll in-nuqqas ta' ġustifikazzjoni għar-rifjut ta' miżuri ta' mitigazzjoni tar-riskji proposti waqt il-proċedura skont l-Artikolu 33(4) tadDirettiva 2001/82 għal Gutal (EMEA/V/A/108).
English: Several published studies demonstrated during in vivo experiments or by investigating environmental isolates a correlation between high doses of zinc supplementation in food and the prevalence of antimicrobial resistant bacteria (LA-MRSA) or of multi-resistant bacterial clones (E. coli).
Maltese: Waqt esperimenti in vivo jew permezz ta' investigazzjoni ta' iżolati ambjentali, diversi studji ppubblikati wrew korrelazzjoni bejn dożi għoljin ta' supplimentazzjoni taż-żingu fl-ikel u l-prevalenza ta' batterji reżistenti għall-antimikrobiċi (LA-MRSA) jew ta' kloni batteriċi multireżistenti (E. coli).
English: The bioavailable fraction of zinc in soils is small (<1%).
Maltese: Ilfrazzjoni bijodisponibbli taż-żingu fil-ħamrija hija żgħira (<1 %).
English: For sediment systems, since the sediment predicted environmental concentration (PEC) was derived (EU RAR, 2010) there have been significant changes in the way sediment concentrations are determined.
Maltese: (PEC) tas-sediment ġiet idderivata (UE RAR, 2010) kien hemm bidliet sinifikanti fil-mod li bih jiġu ddeterminati lkonċentrazzjonijiet tas-sediment.
English: On 1 February 2016, the Netherlands and France presented to the European Medicines Agency a referral notification in accordance with Article 35 of Directive 2001/82/EC for veterinary medicinal products containing zinc oxide to be administered orally to food producing species, due to concerns related to the risk to the environment and the potential increase of prevalence of antibiotic resistant bacteria from the use of products containing zinc oxide.
Maltese: Fl-1 ta' Frar 2016, in-Netherlands u Franza ppreżentaw notifika ta' riferiment lill-Aġenzija Ewropea għall-Mediċini f'konformità mal-Artikolu 35 tad-Direttiva 2001/82/KE għal prodotti mediċinali veterinarji li fihom l-ossidu taż-żingu li għandhom jingħataw mill-ħalq lil speċi ta' produzzjoni alimentari, minħabba tħassib relatat mar-riskju għall-ambjent u ż-żieda potenzjali ta' prevalenza ta' batterji reżistenti għall-antibijotiċi mill-użu ta' prodotti li fihom l-ossidu taż-żingu.
English: The data available shows a beneficial effect of zinc oxide at the dose of 100 mg/kg bw per day (equivalent to 2500 ppm zinc in feed), given in the feed for 12-14 days.
Maltese: Id-data disponibbli turi effett ta' benefiċċju tal-ossidu taż-żingu biddoża ta' 100 mg/kg kull jum (ekwivalenti għal 2500 ppm żingu fl-għalf), li tingħata fl-għalf għal 12-14il jum.
English: Reduction of global use of antibiotics
Maltese: Tnaqqis fl-użu globali ta' antibijotiċi
English: However, differences between the 2500 ppm and the 4000 ppm groups were not observed in this respect.
Maltese: 2500 ppm żingu u 4000 ppm żingu.
English: Despite these uncertainties, considering the nature of the active substance, as an inorganic molecule, and the difficulties identified throughout the application procedure in terms of assessing the environmental risk for a compound ‘outside' of current CVMP/VICH guidance, it may be accepted that the estimated PEC values extrapolated from the IDMM outputs offer a reasonable reflection of the environmental exposure for use in the risk characterisation for Gutal.
Maltese: Minkejja dawn l-inċertezzi, meta titqies in-natura tas-sustanza attiva, bħala molekula inorganika, u d-diffikultajiet identifikati matul il-proċedura ta' applikazzjoni f'termini ta' valutazzjoni tar-riskju ambjentali għal kompost li “jaqa barra" l-gwida CVMP/VICH attwali, jista' jiġi aċċettat li lvaluri PEC stmati estrapolati mill-outputs tal-IDMM joffru riflessjoni raġjonevoli tal-esponiment ambjentali għall-użu fil-karatterizzazzjoni tar-riskju/tar-riskji għal Gutal.
English: 10 CVMP procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing colistin as a sole active substance to be administered orally (Procedure no. EMEA/V/A/106) - link 11 CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) - link combination.
Maltese: 11 CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) - link
English: The marketing authorisation holder Huvepharma, however, did provide robust summaries of the additional peer-reviewed studies used in the effect assessment, that were not included in the EU RAR (2010), including a conclusion on the reliability and validity of each study.
Maltese: Madankollu, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq Huvepharma pprovda sommarji robusti tal-istudji addizzjonali b'rieżami bejn il-pari li ntużaw fil-valutazzjoni tal-effett, li ma kinux inklużi fl-UE RAR (2010), inkluż konklużjoni dwar l-affidabbiltà u l-validità ta' kull studju.
English: Zinc oxide 492 mg/g
Maltese: 492 mg/g
English: In 2015 following a referral procedure (EMEA/V/A/108) under Article 33(4) of Directive 2001/82/EC, for Gutal 1000 g/kg premix for medicated feeding stuff for piglets (thereafter called ‘Gutal')1, a risk to the environment has been identified due to accumulation of zinc, in the terrestrial and aquatic compartment (including sediment), with acidic, sandy, well-drained soils being most vulnerable.
Maltese: Fl-2015, wara pro feriment (EMEA/V/A/108) skont l-Artikolu 33(4) tadDirettiva 2001/82/KE, għal Gutal 1000g/kg taħlita lesta minn qabel għal għalf medikat għall-qżieqeż (minn hawn ‘il quddiem imsejħa “Gutal”)1, ġie identifikat riskju għall-ambjent minħabba akkumulazzjoni ta' żingu, fil-kompartiment terrestri u akkwatiku (inkluż is-sediment), b'ħamrija aċiduża, ramlija u li minnha l-ilma jiskula sew li huma l-aktar vulnerabbli.
English: • the CVMP considered that risk mitigation measures will only dilute and not decrease the total zinc emission output to the environment, and thus it will only be a matter of time before risks are present in all compartments;
Maltese: • is-CVMP ikkunsidra li l-miżuri ta' mitigazzjoni tar-riskji sempliċiment se jiddilwaw u mhux ser inaqqsu l-output totali ta
English: The CVMP does not agree with the marketing authorisation holder's argument that the initial benefit-risk assessment was concluded to be positive for the procedure under Article 33(4) of Directive 2001/82 for Gutal (EMEA/V/A/108).
Maltese: Is-CVMP ma jaqbilx mal-argument tad-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq li lvalutazzjoni benefiċċji/riskji inizjali ġiet konkluża li tkun pożittiva għall-proċedura skont l-Artikolu 33(4) tad-Direttiva 2001/82 għal Gutal (EMEA/V/A/108).
English: Based on the totality of the data available, including the information submitted during the original assessment procedure and the detailed scientific grounds for re-examination put forward by the marketing authorisation holders, the CVMP concluded that there were not sufficient scientific grounds to revise its previous conclusions as included in its opinion of 8 December 2016, which concluded that the overall benefit-risk balance for the veterinary medicinal products containing zinc oxide to be administered orally to food producing species is negative.
Maltese: Abbażi tat-totalità tad-data disponibbli, inkluż l-informazzjoni sottomessa waqt il-proċedura ta' valutazzjoni oriġinali u r-raġunijiet xjentifiċi dettaljati għal eżaminazzjoni mill-ġdid imressqa middetenturi tal-awtorizzazzjoni għat-tqegħid fis-suq, is-CVMP ikkonkluda li ma kienx hemm biżżejjed raġunijiet xjentifiċi sabiex jiġu rreveduti l-konklużjonijiet preċedenti tiegħu kif inkluż fl-opinjoni tiegħu tat-8 ta' Diċembru 2016, li kkonkludew li l-bilanċ globali bejn il-benefiċċju u r-riskju għall-prodotti mediċinali veterinarji li fihom l-ossidu taż-żingu li għandhom jingħataw mill-ħalq lil speċi ta' produzzjoni alimentari huwa negattiv.
English: The data presented support the use of veterinary medicinal product containing zinc oxide for prevention of post-weaning diarrhoea in piglets at the dose of 100 mg/kg bw per day (equivalent to 2500 ppm zinc in feed), for a duration of 14 days.
Maltese: Id-data ppreżentata tappoġġja l-użu ta' prodott mediċinali veterinarju li fih l-ossidu taż-żingu għallprevenzjoni ta' dijarea wara l-ftim fil-qżieqeż bid-doża ta' 100 mg/kg bw kull jum (ekwivalenti għal 2500 ppm żingu fl-għalf), għal durata ta' 14-il jum.
English: Zinc oxide 622 mg/g
Maltese: 622 mg/g
English: However, increases in MRSA prevalence during the administration of zinc oxide to piglets appear partly transient (Slifierz et al., 2015)25.
Maltese: Madankollu, żidiet fil-prevalenza tal-MRSA waqt l-għoti tal-ossidu tażżingu lill-qżieqeż jidher xi ftit tranżitorju (Slifierz et al., 2015)25.
English: Consequently, the CVMP considers that the environmental risk assessment provided during the referral procedure under Article 33(4) of Directive 2001/82/EC for Gutal (EMEA/V/A/108) is scientifically sound and should be used in the benefit-risk evaluation for products containing zinc oxide to be administered orally to food producing species.
Maltese: Konsegwentement, is-CVMP jikkunsidra li l-miżuri ta' mitigazzjoni tar-riskji rakkomandati preċedentement fi ħdan il-kamp ta' applikazzjoni tal-proċedura skont l-Artikolu 33(4) tad-Direttiva 2001/82 għal Gutal (EMEA/V/A/108), sempliċiment se jdewwem ir-riskji identifikati fil-kompartimenti ambjentali kollha jekk id-demel minn ħnieżer ikkurati bi prodotti mediċinali veterinarji li fihom l-ossidu taż-żingu jiġi applikat lill-art.
English: Risks of (co-)selection of resistant bacteria
Maltese: Riskji ta' (ko)selezzjoni ta' batterji reżistenti
English: The posology of aniMedica's veterinary medicinal products (daily dose of 1 g product per 5 kg bw, equivalent to 5 mg colistin sulphate and 96 mg zinc oxide per kg bw, for 5 - 7 days), means that the concentration of zinc oxide in-feed will be 3000 ppm (approximately 2400 ppm zinc).
Maltese: Il-pożoloġija tal-prodotti mediċinali veterinarji ta' aniMedica (doża ta' kuljum ta' 1 g prodott għal kull 5 kg bw, ekwivalenti għal 5 mg colistin sulphate u 96 mg ossidu taż-żingu għal kull kg bw, għal 5
English: The marketing authorisation holders informed the EMA that they had not received the official notification of the inclusion of their products (Pigzin and ZincoTec) in this Article 35 referral procedure.
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq infurmaw lill-EMA li huma ma kinux irċevew innotifika uffiċjali tal-inklużjoni tal-prodotti tagħhom (Pigzin u ZincoTec) f'din il-pro ċedura ta' rif skont l-Artikolu 35.
English: A target animal safety study was performed at the recommended dose (100 mg/kg bw per day during 14 days) and no significant side effects have been observed.
Maltese: Sar studju ta' sigurtà tal-annimali fil-mira bid-doża rakkomandata (100 mg/kg bw kull jum għal 14il jum) u ma ġie osservat l-ebda effett sekondarju sinifikanti.
English: Although the PEC values for each compartment cannot be verified because the IDMM is not provided, overall they appear fairly conservative since a reasonable worst case exposure scenario is considered, i.e. continual application of undiluted manure until 2060.
Maltese: Għalkemm il-valuri PEC għal kull kompartiment ma jistgħux jiġu vverifikati peress li m'hemmx IDMM ipprovdut, b'mod globali jidhru pjuttost konservattivi peress li huwa kkunsidrat l-agħar xenarju possibbli fl-esponiment, jiġifieri applikazzjoni kontinwa ta' demel mhux dilwit sal-2060.
English: Several marketing authorisation holders provided proprietary studies for veterinary medicinal products containing zinc oxide as single active substance.
Maltese: Diversi detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq ipprovdew studji proprjetarji għal prodotti mediċinali veterinarji li fihom l-ossidu taż-żingu bħala sustanza attiva unika.
English: The marketing authorisation holders presented an environmental risk assessment by: a) addressing measured soil concentrations of zinc in (Danish) soils - but not taking into consideration the contributing from the repeated (annual) load of zinc from non-aged pig slurry; and b) by combining two methods for incorporating bioavailability (the so called ‘added risk approach' together with the ‘bioavailability correction approach'), yet the combination of both is not supported by the CVMP.
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq ippreżentaw valutazzjoni tar-riskju ambjentali billi: a) indirizzaw konċentrazzjonijiet imkejla ta' żingu fil-ħamrija, fil-ħamrija (Daniża) - iżda ma kkunsidrawx il-kontribut mit-tagħbija (annwali) repetuta taż-żingu mid-demel likwidu tal-ħnieżer mhux qadim; u b) billi għaqqdu ż-żewġ metodi għall-inkorporazzjoni tal-bijodisponibbiltà (dak l-hekk imsejjaħ “approċċ ta' riskju miżjud” flimkien mal-”approċċ ta' korezzjoni tal-bijodisponibbiltà”), iżda ttaħlita tat-tnejn li huma xorta mhijiex appoġġjata mis-CVMP.
English: Supporting field studies on zinc accumulation in soils were not available during the referral procedure under Article 33(4) of Directive 2001/82/EC for Gutal (EMEA/V/A/108).
Maltese: -Artikolu 33(4) tad-Direttiva 2001/82/KE għal Gutal (EMEA/V/A/108).
English: AVS is produced by bacteria in anoxic sediments.
Maltese: L-AVS huwa prodott ukoll minn batterji f'sedimenti anossiċi.
English: • A risk of zinc to soil dwelling species is already present in clay soil; • A risk of zinc to soil dwelling species is already present in sandy soil.
Maltese: • Riskju ta' żingu fi speċijiet li jabitaw fil-ħamrija diġà huwa preżenti f'ħamrija żejtnija; • Riskju ta' żingu fi speċijiet li jabitaw fil-ħamrija diġà huwa preżenti f'ħamrija ramlija.
English: In conclusion, the combination of colistin and zinc oxide for the approved indication (metaphylaxis and treatment of gastrointestinal infections caused by non-invasive E. coli sensitive to colistin) for seven days duration of administration is not justified.
Maltese: B'konklużjoni, it-taħlita ta' colistin u l-ossidu taż-żingu għall-indikazzjoni approvata (metafilassi u kura ta' infezzjonijiet gastrointestinali kkawżati minn E. coli mhux invażiva sensittiva għal colistin) għal amministrazzjoni ta' durata ta' sebat ijiem mhijiex iġġustifikata.
English: The study was a nonGood Clinical Practice (GCP) single-farm comparative study conducted with 3200 piglets.
Maltese: Klinika Tajba (PKT) u li sar bi 3200 qażquż.
English: As a result, the CVMP considers that the environmental risk assessment presented above for all zinc oxide mono-products is also adequate to predict environmental risks from the use of Enteroxid products in the EU.
Maltese: -CVMP jikkunsidra li l-valutazzjoni tar-riskju ambjentali ppreżentata hawn fuq għall-monoprodotti tal-ossidu taż-żingu kollha hija wkoll adegwata biex jiġu previsti riskji ambjentali mill-użu ta' prodotti Enteroxid fl-UE.
English: The CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005)11 indicates: ‘Any fixed combination product can only be justified, if such a combination offers an advantage over their active substances, when used as single substance products.
Maltese: Il-linja gwida tas-CVMP dwar prodotti farmaċewtiċi ta' taħlita fissa (EMEA/CVMP/83804/2005)11 tindika: “Kwalunkwe prodott ta' taħlita fissa jista' jkun iġġustifikat biss, jekk tali taħlita toffri vantaġġ fuq is-sustanzi attivi tagħhom, meta jintuża bħala prodott ta' sustanza unika.
English: Duration of the protective effect The duration of the protective effect was investigated only in one study (Johansen et al. (2007), in which the follow-up period was approximately 41 days.
Maltese: Id-durata tal-effett protettiv ġiet investigata fi studju wieħed biss (Johansen et al.
English: A summary of results from a study performed by Johansen et al. in Denmark in 20072 considering the effects of zinc oxide on post weaning diarrhoea in piglets have been provided.
Maltese: Ġie pprovdut sommarju ta' riżultati minn studju li sar minn Johansen et al. fid-Danimarka fl-20072 li jqis l-effetti tal-ossidu taż-żingu fuq dijarea ta' wara l-ftim fil-qżieqeż.
English: At the time of the zinc EU RAR (2010) there were too few effects or exposure data to be able to account for the effect of these two parameters (AVS/SEM) on zinc bioavailability in sediments.
Maltese: Meta sar l-UE RAR tażżingu (2010) kien hemm ftit wisq effetti jew data ta' esponiment sabiex jitqies l-effett ta' dawn iż-żewġ parametri (AVS/SEM) dwar il-bijodisponibbltà taż-żingu fis-sedimenti.
English: 12 European Union Risk Assessment Report (EU RAR) on zinc (2010) - link marketing authorisation holders to establish (refine) the PNECs for the relevant environmental compartments.
Maltese: 12 European Union Risk Assessment Report (EU RAR) on zinc (2010) - link 13 Metal bioavailability assessment tool (M-BAT) - link determinazzjoni tal-bijodisponibbiltà (u, b'hekk, l-ekotossiċità) fil-ħamrija huma t-tip ta' ħamrija u l-ħin bejn iż-żieda taż-żingu fil-ħamrija u l-ittestjar tat-tossiċità ("tiqdim").
English: This trend of zinc accumulation on agricultural soils from the veterinary use of zinc oxide has been recently reported by Bak et al. (2015).
Maltese: Din it-tendenza ta' akkumulazzjoni taż-żingu f'ħamrija agrikola mill-użu veterinarju tal-ossidu taż-żingu ġiet irrappurtata riċentement minn Bak et al.
English: However, while the marketing authorisation holder claims a lower exposure and annual load from their products compared to other zinc oxide veterinary medicines, they have not submitted data supporting a quantitative risk assessment, and have not considered that, while their conclusion on a limited environmental release of zinc oxide was estimated from the use of these products on 3-4 week old piglets (7-8 kg), the claim for their products is for pigs up to 40 kg/bw, and treating heavier pigs would also increase the environmental load.
Maltese: Madankollu, waqt li d-detentur talawtorizzazzjoni għat-tqegħid fis-suq jitlob esponiment u tagħbija annwali aktar baxxi mill-prodotti tagħhom meta mqabbel ma' mediċini veterinarji oħrajn li fihom l-ossidu taż-żingu, huwa ma ssottomettiex data li tappoġġja valutazzjoni tar-riskji kwantitattiva, u ma kkunsidrax li, waqt li lkonklużjoni tagħhom dwar rilaxx ambjentali limitat tal-ossidu taż-żingu ġie stmat mill-użu ta' dawn ilprodotti fuq qżieqeż li għandhom 3-4 ġimgħat (7-8 kg), it-talba għall-prodotti tagħhom hija għal ħnieżer sa 40 kg/bw, u jekk jiġu kkurati ħnieżer aktar tqal dan iżid ukoll it-tagħbija ambjentali.
English: It appears that zinc oxide administered at high doses may co-select for antimicrobial resistance, a phenomenon shown in vivo for LA-MRSA ST398.
Maltese: Jidher li l-ossidu taż-żingu li jingħata f'dożi għoljin jista' jikko-selezzjona għal reżistenza antimikrobika, fenomenu li ntwera in vivo għal LA-MRSA ST398.
English: Zinc oxide 600 mg/g
Maltese: 600 mg/g
English: It should be noted that the CVMP is a scientific Committee and that while it operates within the framework of the Union legislation regulating veterinary medicinal products, it cannot discuss the specific merits of procedural and legal aspects of administrative procedures laid down in the legislation.
Maltese: Għandu jiġi nnutat li s-CVMP huwa Kumitat xjentifiku u li filwaqt li jopera fi ħdan il-qafas tal-leġiżlazzjoni tal-Unjoni li tirregola prodotti mediċinali veterinarji, dan ma jistax jiddiskuti l-merti speċifiċi ta' aspetti proċedurali u legali ta' proċeduri amministrattivi stabbiliti fil-le ġiżlazzjoni.
English: There are a number of uncertainties associated with use of the IDMM for predicting the environmental exposure of zinc from use in veterinary medicinal products, such as the effects of hydrology, dissolved organic carbon and metal aging.
Maltese: Hemm numru ta' inċertezzi assoċjati mal-użu tal-IDMM biex jiġi previst l-esponiment ambjentali taż-żingu mill-użu fi prodotti mediċinali veterinarji, bħall-effetti tal-idroloġija, il-karbonju organiku dissolt u t-tiqdim talmetall.
English: For each compartment (soil, water and sediment), zinc bioavailability is dependent on various biotic and abiotic factors.
Maltese: Għal kull kompartiment (ħamrija, ilma u sediment), ilbijodisponibbiltà taż-żingu tiddependi minn diversi fatturi bijotiċi u abijotiċi.
English: Significant reduction of diarrhoea (p<0.02) was observed in animals treated with high zinc diets, although significant differences were not observed between both treatment periods.
Maltese: Ġie osservat tnaqqis sinifikanti ta' dijarea (p<0.02) f'annimali kkurati b'dieti ta' żingu għoli, għalkemm ma ġewx osservati differenzi sinifikanti bejn iż-żewġ perjodi ta' kura.
English: Vilofarm A/S Sjellebrovej 10 DK-8544 Mørke Denmark
Maltese: Id-Danimarka Vilofarm A/S Sjellebrovej 10
English: Zinc oxide 1000 mg/g Oral powder
Maltese: 1000 mg/g Trab orali
English: Considering the use of these products, current EU rules and Good Agricultural Practice on manure spreading, how the target animals are kept and how manure is managed, the suggested risk mitigation measures (dilution of manure and distance to surface waters), although they are in line with the CVMP/VICH guideline (CVMP/VICH/790/03) and were recommended for the referral procedure under Article 33(4) of Directive 2001/82 for Gutal (EMEA/V/A/108), in order to reduce the accumulation of zinc in each compartment, cannot guarantee that they can effectively eliminate either the imminent and future environmental risks identified from the risk assessment, but will just delay the total zinc accumulation in the environment (i.e. the time when the PEC will exceed the PNECs).
Maltese: Gutal skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE (EMEA/V/A/108) sabiex titnaqqas lakkumulazzjoni taż-żingu f'kull kompartiment, ma jistgħux jiggarantixxu li dawn jistgħu jeliminaw b'mod effettiv ir-riskji ambjentali imminenti u futuri identifikati fil-valutazzjoni tar-riskji, iżda sempliċiment se jdewmu l-akkumulazzjoni totali taż-żingu fl-ambjent, (jiġifieri iż-żmien meta l-PEC se jaqbeż l-PNECs).
English: • the CVMP considered that based on the available data the efficacy of veterinary medicinal products containing zinc oxide for prevention of post-weaning diarrhoea in piglets is demonstrated;
Maltese: • is-CVMP kkunsidra li abbażi tad-data disponibbli, tintwera l-effikaċja ta' prodotti mediċinali veterinarji li fihom l-ossidu taż-żingu għall-prevenzjoni ta' dijarea wara l-ftim fil-qżieqeż;
English: • the CVMP considered that based on the available data the clinical benefit of the veterinary medicinal products containing colistin sulfate and zinc oxide cannot be demonstrated;
Maltese: • is-CVMP ikkunsidra li abbażi tad-data disponibbli l-benefiċċju kliniku tal-prodotti mediċinali veterinarji li fihom colistin sulfate u l-ossidu taż-żingu ma jistax jintwera;
English: Indeed, there are examples that some EU Member States already monitor veterinary medicinal products containing zinc oxide consumption (e.g., Denmark, Czech Republic), as well as zinc soil concentrations (e.g., Denmark).
Maltese: Tabilħaqq, hemm eżempji li xi Stati Membri tal-UE diġà jimmonitorjaw prodotti mediċinali veterinarji li fihom ilkonsum tal-ossidu taż-żingu (eż., id-Danimarka, ir-Repubblika Ċeka), kif ukoll konċentrazzjonijiet tażżingu fil-ħamrija (eż., id-Danimarka).