FrancophonIA/ELRC3.0 huggingface dataset:
English: The PECsurfacewater was calculated according to FOCUS STEP 4, considering a DT50 value for soil of 6.5 days (geometric mean derived from four soils), an application rate of 0.000094 kg/ha, the result of the manure degradation study (factor: 0.265), the fraction of herd treatment (factor: 0.49) as well as the metabolism (factor: 0.31).
Maltese: Il-PECilma tal-wiċċ ġiet ikkalkolata skont il-PASS 4 ta' FOCUS, meta wieħed iqis il-valur DT50 għallħamrija ta' 6.5 ijiem (medja ġeometrika meħuda minn erba' ħamriji), rata ta' applikazzjoni ta' 0.000094 kg/ha, ir-riżultat tal-istudju tad-degradazzjoni tad-demel (fattur: 0.265), frazzjoni talkura tal-merħla (fattur: 0.49) kif ukoll il-metaboliżmu (fattur: 0.31).
English: Thus, the PECsoil, and hence PECsurfacewater, could be conservatively reduced by 85% and not only by 69%.
Maltese: Għaldaqstant, il-PECħamrija, u għaldaqstant PECilma tal-wiċċ, jistgħu jitnaqqsu b'mod konservattiv b'85% u mhux b'69% biss.
English: Based on the available data, the marketing authorisation holders (MAHs) considered a worst-case scenario of renal elimination of altrenogest as the major route of excretion with 60% of the total dose of altrenogest being excreted in urine as altrenogest or altrenogest conjugates, and a total amount of 31% altrenogest-equivalents being excreted (considering complete deconjugation).
Maltese: Abbażi tad-dejta disponibbli, id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (MAHs) ikkunsidraw l-agħar xenarju possibbli ta' eliminazzjoni tal-kliewi ta' altrenogest bħala l-mod ewlieni ta' eliminazzjoni b'60% tad-doża totali ta' altrenogest tiġi eliminata fl-awrina bħala altrenogest jew konjugati ta' altrenogest, u ammont totali ta' 31% ta' ekwivalenti ta' altrenogest ikunu eliminati (meta titqies dekonjugazzjoni sħiħa).
English: Based on this more realistic approach, and considering metabolism of up to 85% (release factor 0.15), no risk could be identified for R1 and R4 scenarios (in line with the MAHs calculation considering 69% metabolism, release factor 0.31).
Maltese: Abbażi ta' dan l-approċċ aktar realistiku, u meta wieħed iqis il-metaboliżmu sa 85% (fattur tar-rilaxx 0.15), ma seta' jiġi identifikat l-ebda riskju għax-xenarji R1 u R4 (skont il-kalkolazzjoni tal-MAHs li jqisu metaboliżmu ta' 69%, fattur tar-rilaxx 0.31).
English: The CVMP considered that after administration of altrenogest at a daily oral dose of 20 mg/pig for 18 days, only 25% of the total dose of altrenogest was excreted in urine as altrenogest or altrenogest conjugates, and the remainder in bile.
Maltese: Is-CVMP ikkunsidra li wara l-għoti ta' altrenogest f'doża mill-ħalq ta' kuljum ta' 20 mg/ħanżir għal 18-il jum, 25% biss tad-doża totali ta' altrenogest ġiet eliminata fl-awrina bħala altrenogest jew konjugati ta' altrenogest, u l-bqija fil-bila.
English: Hungary aniMedica GmgH, Im Südfeld 9
Maltese: Ungerija aniMedica GmgH, Im Südfeld 9
English: SPC section 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products.
Maltese: Sezzjoni 6.6 tal-SPC Prekawzjonijiet speċjali għar-rimi tal-prodotti mediċinali veterinarji mhux użati jew materjal ieħor għar-rimi li huwa derivat mill-użu ta' dawn il-prodotti.
English: R4 is often used to cover a conservative run-off scenario in FOCUS-SW and consequently has been used for the exposure assessment for the FOCUS-SW STEP 3 calculations.
Maltese: R4 ta' sikwit jintuża sabiex ikopri xenarju ta' skol konservattiv f'FOCUS-SW u konsegwentement intuża għall-valutazzjoni tal-esponiment għall-kalkolazjonijiet talPASS 3 ta' FOCUS-SW.
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Wim de Körverstraat B.V. 5831 AN Boxmeer The Netherlands
English: 1107 Budapest
Maltese: Ungerija Ceva-Phylaxia Zrt. 1107 Budapest
English: For surface water the FOCUS STEP 2 and 3 (Phase IIA), were conducted as the STEP 1 resulted in a PECsurfacewater larger than the lowest predicted no effect concentration (PNEC) (0.4 ng/l).
Maltese: Għall-ilma tal-wiċċ, il-PASS 2 u 3 ta' FOCUS (Fażi IIA), twettqu hekk kif PASS 1 irriżulta f'PECilma talwiċċ akbar mill-konċentrazzjoni ta' bla effett prevista l-aktar baxxa (PNEC) (0.4 ng/l).
English: The PECsoil initial was further refined with metabolism data (release rate 0.31%), and the rate of gilts that are integrated into the herd that is equivalent to the annual replacement rate (mean value 0.49).
Maltese: Il-PECħamrija inizjali ġiet raffinata aktar bid-dejta tal-metaboliżmu (rata ta' rilaxx 0.31%), u r-rata tal-qżieqeż nisa żgħar li huma integrati fil-merħla li hija ekwivalenti għar-rata annwali ta' sostituzzjoni (valur medju ta' 0.49).
English: Germany expressed concerns that veterinary medicinal products containing altrenogest may present a potential serious risk for the environment as the active substance is a steroid hormone and data from publicly available literature show a high risk to aquatic organisms arising from other steroids with a similar molecular structure.
Maltese: Il-Ġermanja esprimiet tħassib li l-prodotti mediċinali veterinarji li fihom altrenogest jistgħu jippreżentaw riskju serju potenzjali għall-ambjent minħabba li s-sustanza attiva hija ormon sterojde u d-dejta minn letteratura disponibbli b'mod pubbliku turi riskju għoli għall-organiżmi akkwatiċi li ġej minn sterojdi oħrajn bi struttura molekulari simili.
English: To assess the risk to aquatic organisms from the use of veterinary medicinal products in gilts containing the synthetic steroidal hormone altrenogest, the MAHs conducted a Fish Full Life Cycle test to investigate and characterise the endocrine effects of this hormone, and also determined the PECsurfacewater from the use of the product as indicated in the summary of product characteristics (SPC), to establish if the concentrations expected in surface water would exceed the concentration known to cause a detrimental effect to aquatic populations of organisms in different representative EU scenarios (R1: Middle European land, R3: Middle European Mediterranean, and R4: Southern European Mediterranean).
Maltese: Sħiħ tal-Ħut sabiex jinvestigaw u jikkaratterizzaw l-effetti tal-endokrina ta' dan l-ormon, u ddeterminaw ukoll li l-PECilma tal-wiċċ mill-użu tal-prodott kif indikat fis-sommarju talkaratteristiċi tal-prodott (SPC), sabiex jistabilixxu jekk il-konċentrazzjonijiet mistennija fl-ilma talwiċċ humiex ser jaqbżu l-konċentrazzjoni magħrufa li tikkawża effett detrimentali għallpopolazzjonijiet akwatiċi ta' organiżmi f'xenarji rappreżentattivi differenti tal-UE (R1: Art Ewropea tan-Nofs, R3: Mediterran Ewropew tan-Nofs, u R4: Mediterran tan-Nofsinhar tal-Ewropa).
English: Germany considered that, although according to the VICH GL6: Guideline on environmental impact assessment (EIAs) for veterinary medicinal products - Phase I2, the estimated Predicted Environmental Concentrations in soil (PECsoil) for altrenogest (<100 µg/kg) would not trigger a Phase II ERA, hazard concerns related to endocrine disruption and identified in structurally very similar molecules, require a deeper understanding of the potential environmental impacts of altrenogest when used following the recommended use, and a tailored Phase II ERA is consequently considered necessary.
Maltese: I2, il-Konċentrazzjonijiet Ambjentali Previsti fil-ħamrija (PECħamrija) stmati għal altrenogest (<100 µg/kg) mhux ser jagħtu bidu għal ERA tal-Fażi II, tħassib dwar il-periklu relatat mat-tfixkil tal-endokrina u identifikat f'molekuli strutturalment simili ħafna, jeħtieġu fehim aħjar tal-impatti ambjentali potenzjali ta' altrenogest meta użat wara l-użu rakkomandat, u ERA tal-Fażi II imfassla apposta hija konsegwentament ikkunsidrata bħala neċessarja.
English: According to the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of VICH GL6 and GL381 when “adverse environmental effects are anticipated from the use of products, further assessment of possible exposure of the environment can be performed, even if straightforward application of the Phase I guidance would indicate exemption from further testing.” This provision implies that some products, which do not meet the trigger value for entering a Phase II environmental risk assessment (ERA), may however require further assessment to address specifically the concerns related to their activity and use.
Maltese: Skont il-linja gwida tas-CVMP dwar il-valutazzjoni tal-impatt ambjentali għal prodotti mediċinali veterinarji f'appoġġ għal VICH GL6 u GL381 meta “huma antiċipati effetti ambjentali avversi millużu ta' prodotti, tista' titwettaq valutazzjoni ulterjuri tal-esponiment possibbli tal-ambjent, anki jekk l-applikazzjoni diretta tal-gwida tal-Fażi I tindika eżenzjoni minn aktar testijiet."
English: 0.4% w/v Oral suspension Pigs
Maltese: Altrenogest 0.4% w/v Suspensjoni orali
English: Poland Intervet International B.V. Wim de Körverstraat B.V.
Maltese: Polonja Intervet International B.V.
English: Poland Virbac S.A. 1ère avenue
Maltese: Polonja Virbac S.A. 1ère avenue
English: Consequently, based on metabolism studies the Committee concluded that the PECsoil can be more realistically refined considering the total excretion altrenogest-equivalents being 5% to 16.5% of the dose.
Maltese: Konsegwentement, abbażi tal-istudji talmetaboliżmu, il-Kumitat ikkonkluda li l-PECħamrija jista' jkun raffinat b'mod aktar realistiku meta wieħed iqis li l-eliminazzjoni totali tal-ekwivalenti ta' altrenogest hija 5% sa 16.5% tad-doża.
English: Virbac SA 1'ere Avenue 2065 m - LID 06516 Carros Cedex
Maltese: Awstrija Virbac SA 1'ere Avenue 2065 m - LID 06516 Carros Cedex
English: For the Phase I the PECsoil initial for gilts, sows and mares was established using the daily doses and the default values from the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL 38 (EMEA/CVMP/418282/2005Rev.1).
Maltese: Għall-Fażi I il-PECħamrija inizjali għall-qżieqeż nisa żgħar, għall-ħnieżer nisa u għad-dwieb kien stabbilit bl-użu ta' dożi ta' kuljum u l-valuri ta' inadempjenza mil-linja gwida tas-CVMP dwar ilvalutazzjoni tal-impatt ambjentali għall-prodotti mediċinali veterinarji f'appoġġ tal-linji gwida talVICH GL6 u GL38 (EMEA/CVMP/418282/2005-Rev.1).
English: The CVMP acknowledged these results, but concluded that data on the metabolism of altrenogest in gilts, indicating a total amount of excreted altrenogest equivalents corresponding to 5% to 16.5% (release factor 0.05-0.15) of the total dose, should have been considered instead of the release factor of 0.31, given the reliability and quality of the study and its results being in line with existing literature data for progestogens and also with residue concentrations found in liver and kidney of pigs.
Maltese: Is-CVMP għaraf dawn ir-riżultati, iżda kkonkluda li d-dejta dwar il-metaboliżmu ta' altrenogest filqżieqeż nisa żgħar, li tindika ammont totali ta' ekwivalenti ta' altrenogest eliminati li jikkorrespondi għal 5% sa 16.5% (fattur tar-rilaxx 0.05-0.15) tad-doża totali, kellha tiġi kkunsidrata minflok ilfattur tar-rilaxx ta' 0.31, minħabba l-affidabilità u l-kwalità tal-istudju u r-riżultati tiegħu jkunu konformi ma' dejta tal-letteratura eżistenti għal proġestoġeni u anke b'konċentrazzjonijiet tarresidwi misjuba fil-fwied u l-kliewi tal-ħnieżer.
English: Using the scenario R4 (southern European Mediterranean) of the FOCUS STEP 4 modelling the maximum PECsurfacewater for a 1 m, 3 m, 5 m, and 10 m buffer zone were calculated, respectively, in relation to Directive 91/676/EEC6 concerning the protection of waters against pollution caused by nitrates from agricultural sources which is implemented in national law in the EU Member States.
Maltese: L-użu tax-xenarju R4 (Mediterran tan-Nofsinhar tal-Ewropa) tal-immudellar tal-PASS 4 ta' FOCUS, il-PECilma tal-wiċċ massima għal żona ta' lqugħ ta' 1 m, 3 m,5 m u 10 m ġiet ikkalkolata, rispettivament, fir-rigward tad-Direttiva 91/676/KEE6 dwar il-ħarsien tal-ilmijiet kontra t-tniġġis ikkawżat min-nitrati minn sorsi agrikoli li hija implimentata fil-liġi nazzjonali tal-Istati Membri talUE.
English: Romania aniMedica GmbH Im Südfeld 9
Maltese: Rumanija aniMedica GmbH Im Südfeld 9
English: United Kingdom aniMedica GmbH Im Sudfeld
Maltese: Renju Unit aniMedica GmbH Im Sudfeld
English: Poland AniMedica GmbH Im Südfeld 9
Maltese: Polonja AniMedica GmbH Im Südfeld 9
English: However, the CVMP considered that the assumption of 60% of the total dose being excreted via urine as an overly conservative value.
Maltese: Madankollu, is-CVMP ikkunsidra li l-assunzjoni ta' 60% taleliminazzjoni tad-doża totali permezz tal-awrina bħala valur konservattiv iżżejjed.
English: It was concluded that for R1 and R4 scenarios there is no risk for contamination of surface water with altrenogest after spreading manure from treated animals onto cropland, while a risk cannot be excluded for R3-scenario.
Maltese: Ġie konkluż li għax-xenarji R1 u R4 m'hemmx riskju għall-kontaminazzjoni tal-ilma tal-wiċċ b'altrenogest wara t-tifrix tad-demel minn annimali ttrattati fuq l-art tar-raba', filwaqt li ma jistax jiġi eskluż riskju għax-xenarju-R3.
English: No NOEC (No-Observed Effect Concentration) could be derived (NOEC <0.4 ng/l) for altrenogest from the study, especially as analytical limitations proved difficult any further decrease in test concentrations.
Maltese: L-ebda NOEC (Konċentrazzjoni Mingħajr Effetti Osservabbli) ma setgħet tinkiseb (NOEC <0.4 ng/l) għal altrenogest minn dan l-istudju, speċjalment minħabba li aktar tnaqqis fil-konċentrazzjonijiet tat-test irriżulta li hu diffiċli minħabba l-limitazzjonijiet analitiċi.
English: Norway
Maltese: Warsaw
English: Therefore on 21 March 2013 Germany initiated a procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing altrenogest to be administered orally to pigs and horses.
Maltese: Għaldaqstant, fil-21 ta' Marzu 2013, il-Ġermanja tat bidu għal proċedura skont l-Artikolu 35 tadDirettiva 2001/82/KE għal prodotti mediċinali veterinarji li fihom altrenogest sabiex jingħataw millħalq lill-ħnieżer u ż-żwiemel.
English: France aniMedica GmbH Im Südfeld 9
Maltese: Franza aniMedica GmbH Im Südfeld 9
English: The Netherlands aniMedica GmbH Im Südfeld 9
Maltese: Olanda aniMedica GmbH Im Südfeld 9
English: The amount of non-extractable residues (NER) formed after 45 days is used for the predicted environmental concentration in soil (PECsoil) refinement as this value is the closest to the half-maximal manure storage time for sows of 91 days, as explained in the CVMP guideline on the environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1).
Maltese: L-ammont ta' residwi li ma jistgħux jiġu estratti (NER) li ffurmaw wara 45 jum jintuża għall-konċentrazzjoni ambjentali prevista fir-raffinament tal-ħamrija (PECħamrija) minħabba li dan ilvalur huwa l-eqreb għall-ħin ta' ħżin tad-demel ta' nofs il-massimu għall-ħnieżer nisa ta' 91 jum, kif spjegat fil-linja gwida tas-CVMP dwar il-valutazzjoni tal-impatt ambjentali għal prodotti mediċinali veterinarji f'appoġġ tal-linji gwida tal-VICH GL6 u GL38 (EMEA/CVMP/ERA/418282/2005Rev.1).
English: • the CVMP considered that in order to address the risk for fish and other aquatic organisms, risk mitigation measures should be included in the product information;
Maltese: • is-CVMP ikkunsidra li sabiex jiġi indirizzat ir-riskju għall-ħut u organiżmi akwatiċi oħrajn, ilmiżuri ta' mitigazzjoni tar-riskju għandhom ikunu inklużi fl-informazzjoni tal-prodott;
English: The PECsoil initial was further refined using the results from the anaerobic transformation study of altrengest in pig manure which determined that 26.5% accounted for non-extractable residues at day 45, and could be considered potentially bioavailable altrenogest or conjugates of altrenogest.
Maltese: 5% ammonta għal residwi li ma jistgħux jiġu estratti fil-jum 45, u jista'jitqies bħala altrenogest potenzjalment bijodisponibbli jew konjugati ta' altrenogest.
English: Ireland Virbac S.A. 1ère avenue
Maltese: Irelanda Virbac S.A. 1ère avenue
English: Romania Virbac SA 1ère Avenue 2065 m - LID 06516 Carros Cedex France
Maltese: Rumanija Virbac SA 1ère Avenue 2065 m - LID 06516 Carros Cedex France
English: The MAHs proposes the following risk mitigation measure: “When spreading manure from treated animals, the minimum distance to surface water as defined in the national or local regulations has to be strictly respected, because the manure may contain altrenogest which could cause adverse effects in the aquatic environment”.
Maltese: "Meta jitferrex id-demel minn annimali kkurati, id-distanza minima għall-ilma tal-wiċċ kif definit fir-regolamenti nazzjonali jew lokali għandha tiġi rispettatastrettament, minħabba li d-demel jista' jkun fih altrenogest li jista' jikkawża effetti avversi fl-ambjent akwatiku".
English: MG/ML SOLUT ION BUVABLE POUR CHEVAUX
Maltese: REGUMATE EQUIN 2,2 MG/ML SOLUT ION BUVABLE POUR CHEVAUX
English: A fish life cycle test with zebrafish (Danio rerio), covering a complete fish generation (parental) and also part of the filial generation, was conducted to investigate the effects of a continuous exposure of altrenogest on different life stages, (including early life, juvenile growth, and reproduction stages of the parental generation, and early life stages of the filial generation).
Maltese: Sar test taċ-ċiklu tal-ħajja tal-ħut biż-żebra (Danio rerio), li jkopri ġenerazzjoni sħiħa ta' ħut (ġenitriċi) u anke parti mill-ġenerazzjoni ta' dixxendenti, sabiex jinvestiga l-effetti ta' esponiment kontinwu għal altrenogest dwar stadji tal-ħajja differenti, (inkluż ħajja bikrija, kemm jikber il-ħut żgħir, u stadji ta' riproduzzjoni tal-ġenerazzjoni ġenitriċi, u stadji tal-ħajja bikrija tal-ġenerazzjoni
English: Fertilisation rate of the parental fish and post hatch survival of the filial generation were the most sensitive parameters, suggesting that the early life stages of the F1 generation and reproduction are the most sensitive
Maltese: Ir-rata ta' fertilizzazzjoni tal-ħut ġenitur u s-sopravivenza wara t-tfaqqis talġenerazzjoni ta' dixxendenti kienu l-aktar parametri sensittivi, u dan jissuġġerixxi li l-istadji talħajja bikrija tal-ġenerazzjoni F1 u r-riproduzzjoni huma l-aktar stadji tal-ħajja sensittivi għallesponiment ta' altrenogest.
English: • Based on the available data and conservative calculations, the CVMP considered that a risk for fish and other aquatic organisms associated with the zootechnical use of veterinary medicinal products containing altrenogest in gilts cannot be excluded for certain geographical areas;
Maltese: • Abbażi tad-dejta disponibbli u kalkolazzjonijiet konservattivi, is-CVMP ikkunsidra li riskju għallħut u organiżmi akwatiċi oħrajn assoċjat mal-użu żootekniku ta' prodotti mediċinali veterinarji għal ċerta żoni ġeografiċi li fihom altrenogest fil-qżieqeż nisa żgħar ma jistax jiġi eskluż għal ċerti żoni ġeografiċi;
English: Hungary Ceva-Phylaxia Zrt.
Maltese: Qawwa Għamla farmaċewtika
English: To determine PECsurfacewater, the FOCUS STEP 4 approach is the highest tier exposure scenario, in which all relevant and representative R scenarios (R1, R3 and R4) were considered by the CVMP.
Maltese: Sabiex tiġi determinata lPECilma tal-wiċċ, l-approċċ tal-PASS 4 ta' FOCUS huwa x-xenarju tal-esponiment tal-ogħla grad, fejn ix-xenarji-R relevanti u rappreżentattivi kollha (R1, R3 u R4) kienu kkunsidrati mis-CVMP.
English: Germany aniMedica GmbH Im Südfeld 9
Maltese: Germanja aniMedica GmbH Im Südfeld 9
English: • the CVMP considered that veterinary medicinal products containing altrenogest are essential in modern pig production since the oestrus synchronisation of gilts is a tool facilitating strict batch farrowing with obvious benefits for the management and hygiene in these farms, and consequently the health of the animals;
Maltese: • is-CVMP ikkunsidra li prodotti mediċinali veterinarji li fihom altrenogest huma essenzjali filproduzzjoni moderna tal-ħnieżer minħabba li s-sinkronizzazzjoni tal-estru tal-qżieqeż nisa żgħar hija għodda li tiffaċilita twelid tal-ħnieżer f'lott strett b'benefiċċji ovvji għall-ġestjoni u liġjene f'dawn l-azjendi agrikoli, u konsegwentement is-saħħa ta' dawn l-annimali;
English: The MAHs make reference to the Council Directive 91/676/EEC concerning the protection of waters against pollution caused by nitrates from agricultural sources, which requires minimum distances to surface water which must be maintained when manure (or organic fertilizer) is spread onto cropland.
Maltese: Il-MAHs jagħmlu referenza għad-Direttiva tal-Kunsill 91/676/KEE dwar il-ħarsien tal-ilmijiet kontra t-tniġġis ikkawżat min-nitrati minn sorsi agrikoli, li jeħtieġu distanzi minimi għall-ilma tal-wiċċ li għandhom jinżammu meta d-demel (jew fertilizzant organiku) jinfirex fuq l-art tar-raba'.
English: Germany Virbac 1ère Avenue 2065 m - LID 06516 Carros Cedex France
Maltese: Germanja Virbac 1ère Avenue 2065 m - LID 06516 Carros Cedex France
English: Belgium Virbac S.A. 1ère avenue
Maltese: Belġjum Virbac S.A. 1ère avenue
English: From the Fish Full Life Cycle no NOEC can be derived since significant population relevant effects have been shown already in the lowest concentration tested, i.e. 400 pg/l altrenogest (effects on fertilisation and F1 survival being the most sensitive developmental stages).
Maltese: Sħiħ tal-Ħut ma seta' jinkiseb l-ebda NOEC minħabba li l-effetti rilevanti fuq ilpopolazzjoni sinifikanti ntwerew diġà fl-aktar konċentrazzjoni baxxa ttestjata, jiġifieri 400 pg/l ta' altrenogest (bl-effetti fuq il-fertilizzazzjoni u sopravivenza F1 jkunu l-aktar stadji ta' zvilupp sensittivi).
English: Hungary Virbac 1ère avenue 2065 m - LID 06516 Carros Cedex France
Maltese: Ungerija Virbac 1ère avenue 2065 m - LID 06516 Carros Cedex France
English: As a result, PECgroundwater was further refined with the Metamodel (STEP 2) and FOCUS PEARL model, both confirming that PECgroundwater being < 0.000001 μg/l.
Maltese: Bħala riżultat, il-PECilma tal-pjan ġiet raffinata aktar bil-Metamudell (PASS 2) u l-mudell FOCUS PEARL, fejn it-tnejn jikkonfermaw li l-PECilma tal-pjan huwa < 0.000001 μg/l.
English: The PECgroundwater (Phase IIA STEP 1) was calculated using the recommended stepwise approach described in the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL 38 (EMEA/CVMP/418282/2005-Rev.1), STEP 1 to STEP 3.
Maltese: Il-PECilma tal-pjan (Fażi IIA PASS 1) ġiet ikkalkolata bl-użu tal-approċċ pass pass irrakkomandat deskritt fil-linja gwida tas-CVMP dwar il-valutazzjoni tal-impatt ambjentali għall-prodotti mediċinali veterinarji f'appoġġ tal-linji gwida tal-VICH GL6 u GL38 (EMEA/CVMP/418282/2005-Rev.1), PASS 1 għal PASS 3. PASS 1 irriżulta f'PECilma tal-pjan li tkun taħt il-valur tal-limitu (0.1 µg/l), u dan antiċipa li riskju għall-ilma tal-pjan jista' jiġi eskluż fil-prinċipju.
English: Based on the available data and conservative calculations, a risk for fish and other aquatic organisms associated with the zootechnical use of veterinary medicinal products containing altrenogest in gilts cannot be excluded for certain geographical areas (i.e. Middle European Mediterranean).
Maltese: Abbażi tad-dejta disponibbli u kalkolazzjonijiet konservattivi, riskju għall-ħut u għal organiżmi akwatiċi oħrajn assoċjat mal-użu żootekniku ta' prodotti mediċinali veterinarji għal ċerta żoni ġeografiċi li fihom altrenogest fil-qżieqeż nisa żgħar ma jistax jiġi eskluż għal ċerti żoni ġeografiċi (jiġifieri Mediterran Ewropew tan-Nofs).
English: Regumate Equine 2.2 mg/ml oral solution for horses
Maltese: Regumate Equine 2.2 mg/ml oral solution for żwiemel