FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the fact that it was not compared directly with other medicines in its class made it hard to evaluate its potential place in treating erectile dysfunction.
Maltese: Madankollu, il-fatt li ma ġietx imqabbla direttament ma' mediċini oħra fl-istess klassi għamlitha iktar diffiċli biex ikun valutat ilpotenzjal tal-mediċina fil-kura tad-disfunzjoni erettili.
English: The improvement in assessment score was about 5 to 7 points more than with placebo.
Maltese: It-titjib fil-punteġġ tal-valutazzjoni kien madwar 5 u 7 punti iktar minn dak bilplaċebo.
English: Spedra is a medicine used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Maltese: Spedra jintuża fit-trattament ta' rġiel b'disfunzjoni erettili (xi drabi tissejjaħ impotenza), meta ma jkunx jista' jkollhom jew ma jkunux jistgħu jżommu l-pene iebes (erezzjoni) biżżejjed għal attività sesswali sodisfaċenti.
English: 6 (3 x 2) pre-filled syringes (multipack)
Maltese: 1.5 ml (140 mg/ml) 6 (3 x 2) siringi mimlija għal-lest (pakkett multiplu)
English: 2 pre-filled syringes
Maltese: 1.5 ml (140 mg/ml) 2 siringi mimlija għal-lest
English: 9 and GL
Maltese: 9 u GL
English: The marketing authorisation application was submitted to the United Kingdom as reference Member State and Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain as concerned Member States.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq kienet sottomessa lir-Renju Unit bħala Stat Membru ta' referenza u lill-Awstrija, il-Belġju, il-Bulgarija, Ċipru, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, Franza, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, Malta, in-Netherlands, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, is-Slovenja u Spanja bħala l-Istati Membri kkonċernati.
English: Metal bioavailability assessment tool (M-BAT) - http://www.wfduk.org/resources/category/environmental-standardmethods-203/tags/bioavailability-assessment-tool-205/tags/metals-181
Maltese: Environment Agency, United Kingdom Metal bioavailability assessment tool (M-BAT) - http://www.wfduk.org/resources/category/environmental-standardmethods-203/tags/bioavailability-assessment-tool-205/tags/metals-181
English: Chapter R.7b:Endpoint specific guidance Monteiro SC, Lofts S, Boxall ABA.
Maltese: Guidance on information requirements and chemical safety assessment. Chapter R.7b:Endpoint specific guidance Monteiro SC, Lofts S, Boxall ABA. 2010.
English: RMMs.
Maltese: RMMs rilevanti.
English: Effect data
Maltese: Data dwar l-effetti
English: European Union Risk Assessment Report (EU RAR) on zinc (2010)http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/15064/1/lbna24587enn.pdf Environment Agency.
Maltese: European Union Risk Assessment Report (EU RAR) on zinc (2010)http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/15064/1/lbna24587enn.pdf
English: , as indicated in the CVMP reflection paper on RMMs related to the environmental risk assessment of veterinary medicinal products
Maltese: , kif indikat fid-dokument ta' riflessjoni tas-CVMP dwar l-RMMs relatati mal-valutazzjoni tar-riskju ambjentali tal-prodotti mediċinali veterinarji
English: The bioavailable fraction of zinc in soils is small (<1%).
Maltese: Il-frazzjoni talbijodisponibbiltà taż-żingu hija żgħira (<1%).
English: , 7.2 kg zinc ha a-1
Maltese: , 7.2 kg żingu ha a-1
English: To assess the risk for each compartment following extended application of manure to land, PECs and PNEC values for each FOCUS scenario were compared at three time points (years: 2020, 2040, 2060), using two application rates: a worst case application rate (7 kg zinc ha a-1
Maltese: Biex jiġi vvalutat ir-riskju għal kull kompartiment wara li jingħata d-demel lill-art, il-valuri PECs u PNEC għal kull xenarju FOCUS tqabblu fi tliet punti ta' żmien (snin: 2020, 2040, 2060), permezz ta' żewġ rati ta' applikazzjoni: rata fl-agħar każ possibbli (7 kg żingu ha a-1
English: , 3.3 kg zinc ha a-1
Maltese: , 3.3 kg żingu ha a-1
English: EFSA Scientific Opinion on safety and efficacy of zinc compounds (E6) as feed additive for all animal species: Zinc oxide, based on a dossier submitted by Grillo Zinkoxid GmbH/EMFEMA - http://www.efsa.europa.eu/en/search/doc/2970.pdf Forum for Co-ordination of Pesticide Fate Models and their Use (FOCUS) - http://focus.jrc.ec.europa.eu/
Maltese: Zinc oxide, based on a dossier submitted by Grillo Zinkoxid GmbH/EMFEMA - http://www.efsa.europa.eu/en/search/doc/2970.pdf Forum for Co-ordination of Pesticide Fate Models and their Use (FOCUS) - http://focus.jrc.ec.europa.eu/
English: Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium
Maltese: Huvepharma NV Uitbreidingstraat 80 2600
English: The predicted no effect concentrations (PNECs) reported in the European Union Risk Assessment Report (EU RAR) on zinc (2010)
Maltese: Il-konċentrazzjonijiet imbassra mingħajr effett (PNECs) irrapportati fir-Rapport ta' Valutazzjoni tar-Riskji tal-Unjoni Ewropea (EU RAR) dwar iż-żingu (2010)
English: Gutal contains zinc oxide as an active substance.
Maltese: Gutal fih l-ossidu taż-żingu bħala sustanza attiva.
English: The applicant Huvepharma NV submitted a marketing authorisation application, via the decentralised procedure, for Gutal according to Article 13(1) Directive 2001/82/EC, referring to the reference product ZincoTec Zinc Oxide 100% Premix for Medicated Feeding Stuff authorised in the United Kingdom.
Maltese: L-applikant Huvepharma NV issottometta applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq, permezz ta' proċedura deċentralizzata għal Gutal skont l-Artikolu 13(1) tad-Direttiva 2001/82/KE, li tagħmel referenza għall-prodott ta' referenza ZincoTec Ossidu taż-Żingu 100% Taħlita Lesta għal Għalf Medikat fir-Renju Unit.
English: In the terrestrial and aquatic compartments a risk (RQ >1) was found at 4 out of 19 scenarios and at 5 of out 15 scenarios from 2060 onwards, for the worst case and lower application rate, respectively.
Maltese: Fil-kompartimenti terrestri u akwatiċi nstab riskju (RQ >1) f'4 minn 19-il xenarju u f'5 minn 15-il xenarju mill-2060 'il quddiem, għar-rata ta' applikazzjoni fl-agħar każ possibbli u dik aktar baxxa, rispettivament.
English: In order to better indicate the risks posed at application rates considered particularly relevant by the use of Gutal of 8.2 kg zinc ha y-1
Maltese: Sabiex jiġu indikati aħjar ir-riskji maħluqin fir-rati ta' applikazzjoni kkunsidrati partikolarment rilevanti bl-użu ta' Gutal ta' 8.2 kg żingu ha y-1
English: AVS is produced by bacteria in anoxic sediments.
Maltese: L-AVS huwa prodott ukoll minn batterja fis-sedimenti anossiċi.
English: Manure from treated piglets should not be spread on vulnerable soil types, which have been identified as freely draining, acidic (pH ≤6), sandy soils.
Maltese: Iddemel minn qżieqeż trattati m'għandux jinfirex fuq tipi vulnerabbli ta' ħamrija, li ġew identifikati bħala ħamrija liberament poruża, aċiduża (pH ≤6) u ramlija.
English: VICH GL6: Guideline on Environmental Impact Assessment (EIAS) for Veterinary Medicinal Products - Phase I (CVMP/VICH/592/98)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004394.pdf
Maltese: Guideline on Environmental Impact Assessment (EIAS) for Veterinary Medicinal Products - Phase I (CVMP/VICH/592/98)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004394.pdf
English: Various RMMs are proposed which are anticipated to reduce the accumulation of zinc.
Maltese: RMMs li huma mistennija li jnaqqsu l-akkumulazzjoni taż-żingu.
English: It is believed that bioavailability of metals in sediment can be predicted by measuring the acid volatile sulphide (AVS) and the simultaneously extracted metal (SEM) contents of sediments.
Maltese: Huwa maħsub li l-bijodisponibbiltà tal-metalli fis-sediment tista' titbassar billi jitkejjel is-sulfidu volatili tal-aċidu (AVS) u l-kontenut ta' metall estratt simultanjament (SEM) tas-sedimenti.
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: Għas-sistemi tas-sediment, minn meta l-konċentrazzjoni ambjentali mbassra (PEC) tas-sediment ġiet idderivata (EU RAR, 2010) kien hemm bidliet sinifikanti fil-mod li bih jiġu ddeterminati lkonċentrazzjonijiet tas-sediment.
English: In terms of RMMs and in view of the necessity to prevent the accumulation of zinc in environmental compartments above PNEC levels, it has been proposed that undiluted manure from treated piglets should not be applied to land and manure from treated animals be diluted with manure from untreated animals, so that the treated manure comprises 40% or less of the total mixture.
Maltese: F'termini ta' RMMs u fid-dawl tal-ħtieġa li tiġi evitata l-akkumulazzjoni ta' żingu fil-kompartiment ambjentali 'il fuq mil-livelli PNEC, ġie propost li l-art ma għandhiex tingħata demel mhux imħallat minn qżieqeż ikkurati u d-demel mill-annimali kkurati għandu jitħallat b'demel minn annimali mhux ikkurati, biex b'hekk id-demel mhux ittrattat jinkludi 40% jew anqas mit-taħlita totali.
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 titbassar l-espożizzjoni ambjentali taż-żingu mill-użu fi prodotti mediċinali veterinarji, bħall-effetti tal-idroloġija, il-karbonju organiku maħlul u ttiqdim tal-metall.
English: Zinc oxide is included in veterinary medicinal products currently authorised in several EU Member States for use in pigs.
Maltese: L-ossidu taż-żingu huwa inkluż fil-prodotti mediċinali veterinarji attwalment awtorizzati f'diversi Stati Membri tal-UE għall-użu fil-majjali.
English: Following continual application of manure from treated animals, by 2060 an environmental risk (defined by RQ values >1) is seen in 4 of 19 soil scenarios, 5 of 15 surface water scenarios and each of the 15 sediment scenarios.
Maltese: Wara l-applikazzjoni kontinwa ta' demel minn annimali kkurati, sal-2060, riskju ambjentali (iddefinit mill-valuri RQ >1) huwa osservat f'4 minn 19-il xenarju ta' ħamrija, 5 minn 15-il xenarju ta' ilma tal-wiċċ u kull wieħed mill-15-il xenarju tas-sediment.
English: Toxicity will depend on environmental conditions and habitat types.
Maltese: It-tossiċità ser tiddependi fuq kundizzjonijiet ambjentali u tipi ta' abitat.
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 fuq diversi fatturi bijotiċi u abijotiċi.
English: The IDMM predicts the long-term mass balance of metals, with defined inputs (e.g. veterinary medicinal products usage) and outputs (e.g. crop off-take, ageing), and concludes that zinc will accumulate in soil following continual application of treated manure with acidic sandy soils being most vulnerable as these soils have a tendency to accumulate zinc more rapidly than other type of soils and will also have a higher drainage and run-off of zinc to surface water.
Maltese: L-IDMM ibassar li l-bilanċ fit-tul tal-massa tal-metalli, b'kontributi ddefiniti (eż. l-użu ta' prodotti mediċinali veterinarji) u l-kontributi (eż. il-qtugħ tal-uċuħ tar-raba, it-tiqdim), u jikkonkludi li żżingu ser jakkumula fil-ħamrija wara applikazzjoni kontinwa ta' demel ittrattat bil-ħamrija ramlija aċiduża li tkun l-aktar vulnerabbli peress li din il-ħamrija għandha tendenza li takkumula ż-żingu aktar rapidament minn tip ta' ħamrija oħra u ser ikollha drenaġġ u skular aħjar taż-żingu lejn l-ilma tal-wiċċ.
English: 3, a user-friendly version of the Biotic Ligand Model, a model that is used to predict the bioavailable metals for different aquatic species (algae, Daphnia and fish) and has been used and well reported in a large number of peer-reviewed studies for zinc, and the data used in the EU RAR for zinc (2010).
Maltese: 3, verżjoni faċli għall-utent tal-Mudell Biotic Ligand, mudell li jintuża biex jitbassru l-metalli bijodisponibbli għal speċijiet akwatiċi differenti (algi, Daphnia u ħut) u ntuża u ġie rrapportat sew f'numru kbir ta' studji bejn il-pari għaż-żingu, u d-data użata fl-EU RAR għaż-żingu (2010).
English: mineral phases, e.g. iron (oxy)hydroxides and manganese oxides, as well as the organic matter content in sediments.
Maltese: (ossi)idrossidi tal-ħadid u ossidi talmanganiż, kif ukoll il-kontenut ta' materja organika fis-sedimenti.
English: Having considered the above, it can be accepted that the PNECs proposed by the applicant can be used for the characterisation of risks (calculation of risk quotients).
Maltese: Wara li jiġi kkunsidrat dak li ntqal hawn fuq, jista' jiġi aċċettat li l-PNECs proposti mill-applikant jistgħu jintużaw għall-karatterizzazzjoni tar-riskji (kalkolu tal-kwozjenti ta' riskju).
English: The applicant provided the 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: L-applikant ipprovda sommarji b'saħħithom tal-istudji addizzjonali b'reviżjoni bejn il-pari li ntużaw fil-valutazzjoni tal-effett li ma kinux inklużi fl-EU RAR (2010), inkluż konklużjoni dwar l-affidabbiltà u l-validità ta' kull studju.
English: Overall summary of the scientific evaluation of Gutal 1000 g/kg premix for medicated feeding stuff for piglets (see Annex I)
Maltese: Sommarju globali tal-evalwazzjoni xjentifika ta' Gutal 1000 g/kg taħlita lesta minn qabel għal għalf medikat għallqżieqeż (ara l-Anness I)
English: Risk mitigation measures
Maltese: Valutazzjoni tar-riskju
English: Zinc binds strongly to AVS and becomes non-bioavailable, which would allow for making a correction on the exposure assessment for bioavailability of metals in sediment systems (ECHA 2014)
Maltese: Iż-żingu jeħel sew mal-AVS u ma jibqax bijodisponibbli, u dan jippermetti korrezzjoni tal-valutazzjoni tal-espożizzjoni għall-bijodisponibbiltà tal-metalli fis-sistemi tas-sedimenti (ECHA 2014)
English: Package leaflet:
Maltese: VICH GL6:
English: Risks were identified during the decentralised procedure by Belgium, France and the Netherlands who considered that the marketing authorisation of Gutal may present a potential serious risk to the environment and that the risk mitigation measures (RMMs) proposed to control the risk are inadequate to control or prevent continuous zinc accumulation and, in addition, they are not feasible to implement to all pig farms.
Maltese: Matul il-proċedura deċentralizzata ġew identifikati riskji mill-Belġju, Franza u n-Netherlands li kkunsidraw li l-awtorizzazzjoni għat-tqegħid fis-suq ta' Gutal tista' tippreżenta riskju potenzjali serju għall-ambjent u li l-miżuri ta' mitigazzjoni tar-riskji (RMMs) proposti biex jiġi kkontrollat ir-riskju huma inadegwati jew jipprevjenu l-akkumulazzjoni kontinwa taż-żingu u, barra minn hekk, mhumiex fattibbli biex jiġu implimentati fl-irziezet ta-ħnieżer kollha.
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 an reasonable reflection of the environmental exposure for use in the risk characterisation for Gutal.
Maltese: Minkejja dawn l-inċertezzi, fid-dawl tan-natura tas-sustanza attiva, bħala molekula inorganika, u d-diffikultajiet identifikati matul il-proċedura ta' applikazzjoni f'termini ta' valutazzjoni tarriskju ambjentali għal kompost li ma "jaqax" taħt il-gwida CVMP/VICH attwali, jista' jiġi aċċettat li l
English: RQs have been extrapolated (linearly) from application rates of 4 and 7 kg zinc ha a-1
Maltese: u 2.8 kg żingu ha , RQs ġew estrapolati (b'mod lineari) mir-rati ta' applikazzjoni ta' 4 u 7 kg żingu ha a-1
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States
Maltese: Lista ta' ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali veterinarji, mnejn jingħata, l-applikant fl-Istati Membri.
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-EU RAR taż-żingu (2010) kien hemm ftit wisq effetti jew data ta' espożizzjoni sabiex jitqies l-effett ta' dawn iż-żewġ parametri (AVS/SEM) dwar il-bijodisponibbltà taż-żingu fis-sedimenti.
English: The Metal Bioavailability Assessment Tool is based on the outputs from the zinc Biotic Ligand Models and the dataset used in the derivation of the Environmental Quality Standard for zinc, and only requires input data for water pH, dissolved organic carbon and dissolved calcium concentration, but does not take into account the presence of other ions that could affect zinc speciation and, hence, bioavailability.
Maltese: L-Għodda ta' Valutazzjoni tal-Bijodisponibbiltà tal-Metall teħtieġ inqas kontributi ta' data biex titbassar il-bijodisponibbiltà taż-żingu fl-ilma mill-Mudell Biotic Ligand, u tista' tintuża biex jiġu kkalkolati PNECs speċifiċi għas-sit.
English: The combination of a conservative PNEC (not accounting for bioavailability) and PEC may result in an overestimate of the risk due to zinc in sediments.
Maltese: Il-kombinazzjoni ta' PNEC konservattiva (li ma tikkunsidrax il-bijodisponibbiltà) u l-PEC tista' tirriżulta fi stima eċċessiva tar-riskju minħabba żingu fis-sedimenti.
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, kumplessivament jidhru pjuttost konservattivi peress li huwa kkunsidrat xenarju raġonevoli fl-agħar każ possibbli, jiġifieri applikazzjoni kontinwa ta' demel mhux imħallat sal-2060.
English: The proposed indication for Gutal is for the prevention of postweaning diarrhoea in piglets.
Maltese: L-indikazzjoni proposta għal Gutal hija għall-prevenzjoni ta' dijarea wara l-ftim tal-qżieqeż.
English: Ireland Huvepharma NV Uitbreidingstraat 80
Maltese: L-Irlanda Huvepharma NV Uitbreidingstraat 80
English: The IDMM also considers several soil compartments and the fluxes between these and aquatic compartments.
Maltese: L-IDMM jikkunsidra wkoll diversi kompartimenti tal-ħamrija u l-flussi bejn dawn ilkompartimenti akwatiċi.
English: Zinc is very toxic to aquatic organisms and is persistent in soils and sediments.
Maltese: Iż-żingu huwa tossiku ħafna għal organiżmi akwatiċi u hu persistenti fil-ħamrija u s-sedimenti.
English: For two of the FOCUS scenarios (acidic, sandy soils) the risk quotients (RQs) are >1 for both loading rates at all time points.
Maltese: Għal żewġ xenarji FOCUS (ħamrija ramlija, aċiduża) il-kwozjenti ta' riskju (RQs) huma >1 għaż-żewġ rati ta' tagħbija fil-punti ta' żmien kollha.
English: In soil, properties such as pH, organic carbon content, cation exchange capacity, and clay content determine bioavailability in the terrestrial compartment.
Maltese: Fil-ħamrija, proprjetajiet bħall-pH, il-kontentut ta' karbonju organiku, il-kapaċità ta' skambju katjoniku, u l-kontenut ta' tafal jiddeterminaw il-bijodisponibbiltà fil-kompartiment terrestri.
English: A risk was identified from 2020 for two of 15 surface water scenarios (acidic, sandy soils) and for all 15 sediment scenarios.
Maltese: Ġie identifikat riskju mill2020 għal żewġ xenarji minn 15-il xenarju tal-ilma tal-wiċċ (ħamrija aċiduża, ramlija) u għall-15il xenarju tas-sediment kollha.
English: Thus, a model used by EFSA for estimating the environmental exposure from the use of zinc oxide as feed additive, the Intermediate Dynamic Model for Metal (IDMM) by Monteiro et al. (2010)
Maltese: Għalhekk, mudell użat mill-EFSA għall-istima tal-espożizzjoni ambjentali mill-użu tal-ossidu tażżingu bħala addittiv tal-għalf, il-Mudell Dinamiku Intermedju għall-Metall (IDMM) minn Monteiro et al.
English: The applicant has generated RQ values for alternative application rates via linear extrapolation of the IDMM results for application rates of 4 and 7 kg zinc ha a-1
Maltese: L-applikant iġġenera valuri RQ għal rati ta' applikazzjoni alternattivi permezz ta' estrapolazzjoni lineari tar-riżultati
English: Bulgaria Huvepharma NV Uitbreidingstraat 80
Maltese: Il-Bulgarija Huvepharma NV Uitbreidingstraat 80
English: Gutal 1000 g/kg premix for medicated feeding stuff for piglets (thereafter called ‘Gutal') contains zinc oxide as an active substance.
Maltese: Gutal 1000 g/kg taħlita lesta għal għalf medikat għall-qżieqeż (minn hawn 'il quddiem imsejjaħ ‘Gutal') fih l-ossidu taż-żingu bħala sustanza attiva.
English: Although there are uncertainties with the linear extrapolation of the IDMM results, the PEC values extrapolated from the IDMM outputs are considered to offer a reasonable reflection of the environmental exposure for use in the risk characterisation for Gutal.
Maltese: valuri PEC stmati estrapolati mill-prodotti tal-IDMM joffru riflessjoni raġonevoli tal-espożizzjoni ambjentali għall-użu fil-karatterizzazzjoni tar-riskji għal Gutal.
English: Slovakia Huvepharma NV Uitbreidingstraat 80
Maltese: Is-Slovakja Huvepharma NV Uitbreidingstraat 80
English: Slovenia Huvepharma NV Uitbreidingstraat 80
Maltese: Is-Slovenja Huvepharma NV Uitbreidingstraat 80
English: • Since the marketing authorisation application was submitted in accordance with Article 13(1) of Directive 2001/82/EC and bioequivalence was accepted, the benefit-risk for Gutal is considered to be equivalent to that of the reference product, ZincoTec - Zinc Oxide 100% Premix for Medicated Feeding Stuff.
Maltese: • Peress li l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq ġiet sottomessa skont lArtikolu 13(1) tad-Direttiva 2001/82/KE u l-bijoekwivalenza kienet aċċettata, il-benefiċċju/riskju għal Gutal huwa kkunsidrat ekwivalenti għal dak tal-prodott ta' referenza, ZincoTec - Ossidu tażŻingu 100% Taħlita Lesta Minn Qabel għal Għalf Medikat.
English: 4 which incorporates parameters relevant to determine soil zinc bioavailability, such as pH, organic and clay content, and the cation exchanged capacity.
Maltese: 4 li jinkorpora parametri rilevanti biex tiġi ddeterminata lbijodisponibbiltà taż-żingu fil-ħamrija bħall-pH, il-kontenut organiku u tat-tafal, u l-kapaċità ta' skambju tal-kazzjoni.
English: In order to reduce the risk from the accumulation of zinc in environmental compartments, a number of RMMs are proposed to be included in the product information.
Maltese: Sabiex jitnaqqas ir-riskju mill-akkumulazzjoni taż-żingu fil-kompartimenti ambjentali, huwa propost li jiġu inklużi numru ta' RMMs fl-informazzjoni tal-prodott.
English: Environment Agency, United Kingdom for zinc), and were used by the applicant to establish different PNECs for each environmental compartment.
Maltese: 2 għaż-żingu), u ntużat mill-applikant biex jiġu stabbiliti PNECs differenti għal kull kompartiment ambjentali.