FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean non-extractable residues at day 120 (% of applied radioactivity) were 7.22%, 5.23%, 10.15% and 5.38% for the soils sandy loam, sand, clay loam and loam, respectively.
Maltese: Ir-residwi medji li ma jistgħux jiġu estratti f'jum 120 (% ta' radjuattività applikata) kienu ta' 7.22 %, 5.23 %, 10.
English: • Evidence of a trend i.e. increasing/decreasing concentrations or plateau.
Maltese: • Evidenza ta' tendenza, jiġifieri konċentrazzjonijiet li jiżdiedu/jonqsu jew plateau.
English: While the BCF for moxidectin exceeds the established threshold for classification as a bioaccumulative substance, marketing authorisation holders argued that the metabolism studies in the target animals showed no indication of bioaccumulation, based on a steady decline of moxidectin levels in fat after treatment with half-lives of 9 days for muscle to 12-14 days for fat tissues.
Maltese: Waqt li l-BCF għal moxidectin jaqbeż il-limitu stabbilit bħala sustanza bijoakkumulattiva, id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq argumentaw li l-istudji dwar il-metaboliżmu fl-annimali fil-mira ma wrew l-ebda indikazzjoni ta' bijoakkummulazzjoni, abbażi ta' tnaqqis fiss tal-livelli ta' moxidectin fix-xaħam wara l-kura b'nofs ħajjiet ta' 9 ijiem għall-muskolu sa 12-14-il jum għat-tessuti tax-xaħam.
English: D. For veterinary medicinal products listed in Annex I as solution for injection and administered to sheep containing 10 mg moxidectin per ml or 20 mg moxidectin per ml
Maltese: Għal prodotti mediċinali veterinarji elenkati fl-Anness I bħala soluzzjoni għall-injezzjoni u li jingħataw lin-ngħaġ li fihom 10 mg moxidectin għal kull ml jew 20 mg moxidectin għal kull ml
English: Oral solution 1 mg/ml 50 mg/ ml
Maltese: 1 mg/ml 50 mg/ml
English: Oral solution 1 mg/ml 50 mg/ml
Maltese: 1 mg/ml 50 mg/ ml
English: Germany was of the opinion that a potential serious risk to the environment may arise from the use of veterinary medicinal products containing moxidectin and consequently, action should be taken at EU level since veterinary medicinal products containing moxidectin are authorised in the majority of the EU/EEA Member States.
Maltese: Il-Ġermanja kienet tal-opinjoni li jista' jkun hemm riskju serju potenzjali għall-ambjent mill-użu ta' prodotti mediċinali veterinarji li fihom moxidectin u konsegwentement, għandha tittieħed azzjoni fil-livell tal-UE peress li prodotti mediċinali veterinarji li fihom moxidectin huma awtorizzati fi-maġġoranza tal-Istati Membri tal-UE/tażŻEE.
English: • Indication for seasonal variation of the moxidectin concentrations due to different temperature, humidity, soil properties and, if applicable, for regional variation as well.
Maltese: • Indikazzjoni għal varjazzjoni staġjonali tal-konċentrazzjonijiet ta' moxidectin minħabba temperatura, umdità, proprjetajiet tal-ħamrija differenti u, jekk tkun applikabbli, għal varjazzjoni reġjonali wkoll.
English: Slovenia Zoetis Belgium SA Rue Laid Burniat, 1
Maltese: Is-Slovenja Zoetis Belgium SA Rue Laid Burniat, 1
English: The CVMP considered the experimental laboratory study on [3H]-moxidectin transformation in soils in accordance with OECD guideline no. 307 the most reliable and appropriate reference for assessing the persistence of moxidectin in different soil types and determining the DT50 for the substance.
Maltese: Is-CVMP ikkunsidra l-istudju tal-laboratorju sperimentali dwar it-trasformazzjoni ta' [3H]-moxidectin filħamriji skont il-linja gwida tal-OECD nru 307 bħala l-aktar referenza affidabbli u xierqa għallvalutazzjoni tal-persistenza ta' moxidectin f'tipi differenti ta' ħamrija u għad-determinazzjoni tad-DT50 għas-sustanza.
English: Thus, to verify the weight of evidence approach as proposed by the marketing authorisation holders, and to assess whether the theoretical hazards translate into environmental impacts, the Committee considered that a targeted sampling in the environment following the use of veterinary medicinal products as a pour-on solution containing 5 mg moxidectin per ml or as a solution for injection containing 100 mg moxidectin per ml in beef cattle in pasture animals is necessary to obtain a better understanding of the actual environmental exposure.
Maltese: Ġie kkunsidrat li huwa meħtieġ kampjunar fil-mira fl-ambjent wara l-użu ta' prodotti mediċinali veterinarji bħala soluzzjoni li titferra' li fiha 5 mg moxidectin għal kull ml jew bħala soluzzjoni għal injezzjoni li fiha 100 mg moxidectin għal kull ml filgendus f'annimali li jirgħu għal tliet snin konsekuttivi sabiex jinkiseb fehim aħjar tal-esponiment ambjentali attwali.
English: • the CVMP considered that based on the available data moxidectin fulfils the criteria for persistence, bioaccumulation and toxicity according to the results of the laboratory studies and consequently, has to be classified as a persistent, bioaccumulative and toxic (PBT) substance;
Maltese: • s-CVMP kkunsidra li abbażi tad-dejta disponibbli moxidectin jissodisfa l-kriterji għal persistenza, bijoakkumulazzjoni u tossiċità skont ir-riżultati tal-istudji tal-laboratorju u konsegwentement, għandu jiġi kklasifikat bħala sustanza persistenti, bijoakkumulattiva u tossika (PBT) ;
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali veterinarji, speċi ta' annimali, mnejn jingħata, lapplikanti/id-detenturi tal-awtorizzazzjoni għat-tqegħid fissuq fl-Istati Membri
English: Finland Zoetis Finland Oy Tietokuja 4
Maltese: Il-Finlandja Zoetis Finland Oy Tietokuja 4
English: This study was considered as being not valid, because: the reliability of the study cannot be evaluated; the study design and test requirements did not comply with the OECD guideline no. 307; the test substance concentrations were determined on one sample point only at day 63, consequently dissipation kinetics are not available and a sound DT50 cannot be derived; and, the reported DT50 of approximately 63 days is only a very rough estimation.
Maltese: Dan l-istudju ġie kkunsidrat bħala wieħed mhux validu, minħabba li: l-affidabbiltà tal-istudju ma tistax tiġi vvalutata, ittfassil tal-istudju u r-rekwiżiti tat-test ma kkonformawx mal-linja gwida tal-OECD nru 307; ilkonċentrazzjonijiet tas-sustanza tat-test ġew determinati fuq punt ta' kampjun wieħed biss f'jum 63, konsegwentement il-kinetiċi ta' dissipazzjoni ma kinux disponibbli u ma setax jiġi derivat DT50 sod; u, d-DT50 irrappurtat ta' madwar 63 jum huwa biss stima ħafifa ħafna.
English: One major degradation product (>10% of applied radioactivity) was observed in all four soils which reached mean maximum levels of 37.81%, 29.12%, 42.97% and 31.14% of applied radioactivity, respectively.
Maltese: 12 %, 42.97 % u 31.14 % ta' radjuattività applikata, rispettivament.
English: PECsurfacewater run-off (ng/l) 0.239 (cattle, solution for injection containing 100 mg moxidectin per ml)
Maltese: 0.239 (frat, soluzzjoni għall-injezzjoni li fiha 100 mg moxidectin għal kull ml)
English: PBT Assessment
Maltese: Valutazzjoni ta' PBT
English: The CVMP recommended risk mitigation measures to be included in the product information for all concerned products in order to mitigate the risk to aquatic and sediment organisms, including exclusion times for limited access to water courses for each target species.
Maltese: Is-CVMP irrakkomanda li jiġu inklużi miżuri ta' mitigazzjoni tar-riskji fl-informazzjoni dwar il-prodott għall-prodotti kkonċernati kollha sabiex jitnaqqas ir-riskju għal organiżmi akwatiċi u tas-sediment, inkluż ħinijiet ta' esklużjoni għal aċċess limitat għal nixxigħat tal-ilma għal kull speċi fil-mira.
English: The effect of prolonged exposure of moxidectin on the early life stages of the fathead minnow, (Pimephales promelas), was investigated in a GLP compliant study according to OECD guideline no. 21011.
Maltese: L-effett ta' esponiment fit-tul ta' moxidectin fl-istadji bikrin tal-ħajja tal-karpjun buras, (Pimephales promelas), ġie investigat fi studju konformi mal-GLP skont il-linja gwida nru. 210 tal-OECD11.
English: Ireland Continental Farmaceutica Rue Laid Burniat 1,
Maltese: L-Irlanda Continental Farmaceutica Rue Laid Burniat 1,
English: The maximum PECsoil_initial equals 4.18 µg/kg dry weight for cattle after subcutaneous route of administration (injectable products) using a dose of 0.5 mg/kg bodyweight and the respective default values.
Maltese: Il-PECħamrija_inizjali massima hija 4.18 µg/kg piż niexef għall-frat wara għoti taħt il-ġilda (prodotti injetabbli) bl-użu ta' doża ta' 0.5 mg/kg piż tal-ġisem u l-valuri prestabbiliti rispettivi.
English: 18,92 mg Horse and pony
Maltese: 18,92 mg Żiemel u poni
English: The CVMP guideline on the assessment of PBT/vPvB substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012) suggests that the standard approach used to determine the risk to the environment associated with veterinary medicinal products (risk quotient approach, where a risk is characterised by calculating the Predicted Environmental Concentration (PEC)/Predicted No Effect Concentration (PNEC) ratio) is not appropriate for substances classified as PBT.
Maltese: PBT/vPvB fi prodotti mediċinali veterinarji (EMA/CVMP/ERA/52740/2012) tissuġġerixxi li l-approċċ standard li jintuża biex jiġi ddeterminat irriskju għall-ambjent assoċjat ma' prodotti mediċinali veterinarji (approċċ ta' kwozjent tar-riskju, fejn riskju jiġi kkaratterizzat billi jiġi kkalkulat il-proporzjon tal-Konċentrazzjoni Ambjentali Prevista (PEC)/Konċentrazzjoni ta' Bla Effett Previst (PNEC) mhuwiex xieraq għal sustanzi kklassifikati bħala PBT. Għalhekk, saret valutazzjoni tar-riskju kwalitattiva, jiġifieri l-probabbiltà li jkun hemm persistenza, bijoakkumulazzjoni u tossiċità, mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq, meta jiġi kkunsidrat approċċ ta' piż tal-evidenza.
English: The CVMP considered that moxidectin fulfils the criteria for persistence (P), bioaccumulation (B) and toxicity (T) according to the results of the laboratory studies and consequently, has to be classified as a PBT substance.
Maltese: Is-CVMP ikkunsidra li moxidectin jissodisfa l-kriterji għal persistenza (P), bijoakkumulazzjoni (B) u tossiċità (T) skont ir-riżultati tal-istudji tal-laboratorju u konsegwentement, għandu jiġi kklassifikat bħala sustanza PBT.
English: Earthworms were exposed to moxidectin in artificial soil over a 28-day exposure period, followed by an additional test period of four weeks where the number of offspring hatched from the cocoons was determined.
Maltese: Ilħniex ġew esposti għal moxidectin f'ħamrija artifiċjali għal fuq perjodu ta' esponiment ta' 28 jum, segwit minn perjodu tat-test addizzjonali ta' erba' ġimgħat fejn ġie determinat in-numru ta' frieħ li faqqsu mill-fosdqiet.
English: Two GLP compliant studies on acute toxicity to daphnids were provided.
Maltese: Ġew ipprovduti tliet studji konformi mal-GLP dwar tossiċità akuta fil-ħut.
English: Dung fauna
Maltese: Repubblika Ċeka
English: It was considered that degradation in soil might be faster under higher temperatures, that aquatic toxicity and bioaccumulation might be reduced due to intermittent rather than continuous exposure, and that moxidectin would adsorb rapidly to sediment.
Maltese: Ġie kkunsidrat li d-degradazzjoni fil-ħamrija tista' tkun aktar mgħaġġla taħt temperaturi ogħla, li t-tossiċità u l-bijoakkumulazzjoni akwatiċi jistgħu jitnaqqsu minħabba esponiment intermittenti aktar milli kontinwu, u li moxidectin jassorbi malajr għas-sediment.
English: The EC50 (the concentration of a test substance which results in 50% of the test animals being adversely affected, i.e., both mortality and sub-lethal effects) of moxidectin was therefore concluded to be >0.11 mg/l; the No Observed Effect Concentration (NOEC) was determined as ≥ 0.11 mg/l based on geometric mean of measured test concentrations.
Maltese: 11 mg/l; il-Konċentrazzjoni Bla Effett Osservat (NOEC, No Observed Effect Concentration) ġiet iddeterminata bħala ≥ 0.11 mg/l abbażi talmedja ġeometrika ta' konċentrazzjonijiet tat-test imkejla.
English: Cydectin 0,5% Pour-on Moxidectin Pour-on solution 5 mg/ml
Maltese: Cydectin 0,5% Pour-on Moxidectin Soluzzjoni li titferra'
English: The first study was conducted with [3H]-moxidectin and resulted in a NOEC and lowest observed effect concentration (LOEC) for reproduction as well as for parental growth at 0.0031 μg/l and 0.025 µg/l, respectively.
Maltese: Ġew ippreżentati żewġ studji konformi mal-GLP dwar l-effetti tar-riproduzzjoni tad-dafnidi f'konformità mal-linja gwida nru 2118 tal-OECD. L-ewwel studju sar b'[3H]-moxidectin u rriżulta f'NOEC u f'konċentrazzjoni bl-inqas effett osservat (LOEC) għar-riproduzzjoni kif ukoll għal tkabbir ġenitriku b'0.0031 μg/l u 0.025 µg/l, rispettivament.
English: Lithuania Zoetis Belgium SA Rue Laid Burniat, 1
Maltese: Il-Litwanja Zoetis Belgium SA Rue Laid Burniat, 1
English: • A pour-on solution containing 5 mg moxidectin per ml or a solution for injection containing 100 mg moxidectin per ml in beef cattle on pasture should be used as this represents a realistic worst case emission scenario.
Maltese: • Għandha tintuża soluzzjoni li titferra' li fiha 5 mg moxidectin għal kull ml jew soluzzjoni għall-injezzjoni li fiha 100 mg moxidectin għal kull ml fil-gendus li jirgħa peress li din tirrappreżenta xenarju realistiku tal-agħar każ possibbli ta' emissjoni.
English: Lithuania Continental Farmaceutica Rue Laid Burniat 1,
Maltese: Il-Litwanja Continental Farmaceutica Rue Laid Burniat 1,
English: 0.025 (cattle, pour-on)
Maltese: 0.025 (frat, li jitferra')
English: In sheep, oral administration of the combination products is intended for the treatment of gastrointestinal nematodes, respiratory tract nematodes and trematode (fluke) infestations.
Maltese: Fin-ngħaġ, l-għoti orali tal-prodotti kkombinati huwa intiż għall-kura ta' nematodi gastrointestinali, nematodi tal-apparat respiratorju u infestazzjonijiet ta' trematodi (fluke).
English: Concentration
Maltese: Konċentrazzjoni
English: Finland Continental Farmaceutica Rue Laid Burniat 1,
Maltese: Il-Finlandja Continental Farmaceutica Rue Laid Burniat 1,
English: Romania Zoetis Belgium SA Rue Laid Burniat, 1
Maltese: Ir-Rumanija Zoetis Belgium SA Rue Laid Burniat, 1
English: Under
Maltese: Il
English: CYDECTIN SOLUCIÓN INYECTABLE AL 1% PARA GANADO VACUNO
Maltese: INYECTABLE AL 1% PARA GANADO VACUNO
English: Moxidectin Oral gel
Maltese: Moxidectin Sospensjoni orali
English: For sheep, the subcutaneous route of administration (injectable products) resulted in a PECsurfacewater of 0.122 ng/l for run-off. For horses, the oral use resulted in a PEC of 0.3 ng/l for run-off.
Maltese: Għan-ngħaġ, ir-rotta taħt il-ġilda (prodotti injetabbli) irriżultat f'PECilma tal-wiċċ ta' 0.122 ng/l għall-iskol.
English: Based on the results, a DT50 of 296.6 days normalised to 12 °C (DT50 139.0 days at 20 °C) as recommended in the CVMP guideline on the assessment of PBT/vPvB substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012), is used to confirm that moxidectin fulfils the vP (very persistent) criterion (i.e. the DT50 in soil is higher than 180 days).
Maltese: PBT/vPvB fi prodotti mediċinali veterinarji (EMA/CVMP/ERA/52740/2012), jintuża biex jikkonferma li moxidectin jissodisfa lkriterju vP (ta' persistenza għolja) (jiġifieri, id-DT50 fil-ħamrija huwa ogħla minn 180 jum).
English: B. For veterinary medicinal products listed in Annex I as solution for injection and administered to cattle containing 10 mg moxidectin per ml or 100 mg moxidectin per ml
Maltese: Għal prodotti mediċinali veterinarji elenkati fl-Anness I bħala soluzzjoni għall-injezzjoni u li jingħataw lil frat li fihom 10 mg moxidectin għal kull ml jew 100 mg moxidectin għal kull ml
English: Other precautions regarding impact on the environment
Maltese: CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines
English: Sweden Zoetis Finland Oy Tietokuja 4
Maltese: L-Iżvezja Zoetis Finland Oy Tietokuja 4
English: The non-standard field studies indicated that the risk derived from laboratory tests may not fully reflect what is observed under field conditions of use; differences were shown in sensitivity of dung beetle and dung fly and additionally a lower toxicity of moxidectin compared to other avermectins.
Maltese: L-istudji fuq il-post mhux standard indikaw li r-riskju derivat mit-testijiet tal-laboratorju jistgħu ma jirriflettux b'mod sħiħ x'jiġi osservat taħt kundizzjonijiet tal-użu tal-post; intwerew differenti fissensittività tal-ħanufs tad-demel u tad-dubbien tad-demel u barra minn hekk, tossiċità aktar baxxa ta' moxidectin meta mqabbel ma' avermettini oħrajn.
English: Under the conditions of the study, the 48-hour EC50 value for immobilisation was established as 30.2 ng/l.
Maltese: Taħt il-kondizzjonijiet tal-istudju, il-valur EC50 ta' 48 siegħa għall-immobilizzazzjoni ġie stabbilit bħala 30.2 ng/l.
English: Although the efficacy of veterinary medicinal products containing moxidectin has not been re-assessed specifically in this referral procedure, these pour-on, injectable and oral products are considered effective veterinary medicines in the treatment of the abovementioned internal and external parasites in cattle, sheep and horses.
Maltese: Għalkemm l-effikaċja ta' prodotti mediċinali veterinarji li fihom moxidectin ma ġietx ivvalutata mill-ġdid speċifikament f'din il-proċedura ta' referenza, dawn il-prodotti li jitferrgħu, injetabbli u orali huma kkunsidrati mediċini veterinarji effettivi fi-kura tal-parassiti interni u esterni msemmijin hawn fuq filfrat, fin-ngħaġ u fiż-żwiemel.
English: Subcutaneous
Maltese: Kundizzjonijiet
English: CYDECTIN 10% LA Moxidectin Solution for injection
Maltese: CYDECTIN 10% LA Moxidectin Soluzzjoni għallinjezzjoni
English: Belgium Continental Farmaceutica Rue Laid Burniat 1,
Maltese: Il-Belġju Continental Farmaceutica Rue Laid Burniat 1,
English: Furthermore, the marketing authorisation holders argued that bioaccumulation tested under laboratory conditions, i.e. continuous exposure under flow-through conditions, is not reflecting realistic exposure in the field.
Maltese: Barra minn hekk, id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq argumentaw li l-bijoakkumulazzjoni ttestjata taħt kondizzjonijet tal-laboratorju, jiġifieri esponiment kontinwu taħt kondizzjonijiet bi fluss kontinwu, mhijiex tirrifletti esponiment realistiku fil-post.
English: More importantly, moxidectin poses a hazard due to its PBT properties that can neither be eliminated by risk mitigation measures nor can the emission into the environment be prevented.
Maltese: B'mod aktar importanti, moxidectin joħloq riskju minħabba l-proprjetajiet PBT tiegħu li la jistgħu jiġu eliminati permezz ta' miżuri ta' migitazzjoni tar-riskji u lanqas ma tista' tiġi evitata lemissjoni fl-ambjent.
English: Horse
Maltese: Frat
English: The bioconcentration factors were also determined as a function of lipid content of the fish following normalisation for a lipid content of 5%.
Maltese: Il-fatturi ta' bijokonċentrazzjoni ġew ukoll iddeterminati bħala funzjoni tal-kontenut ta' lipidi tal-ħut wara normalizzazzjoni għal kontenut ta' lipidi ta' 5 %.
English: Conclusion on the PBT assessment
Maltese: Konklużjoni dwar il-valutazzjoni ta' PBT
English: Two GLP compliant studies were provided on toxicity to sediment dwelling organisms in accordance with OECD guideline 21812.
Maltese: Ġew ipprovduti żewġ studji konformi mal-GLP dwar it-tossiċità għal organiżmi li jgħixu fis-sediment f'konformità mal-linja gwida 218 tal-OECD12.
English: In cattle, subcutaneous administration of the injectable products is intended for the treatment and prevention of gastro-intestinal nematodes, respiratory tract nematodes, warble grubs, lice and mange mites.
Maltese: Fil-frat, l-għoti taħt il-ġilda tal-prodotti injetabbli huwa intiż għall-kura u l-prevenzjoni ta' nematodi gastrointestinali, nematodi tal-apparat respiratorju, larva tal-warble, qamel u dud bil-marda tal-ġilda.
English: In horses and ponies, oral administration of the monoproducts is intended for the treatment of large and small strongyles, ascarids and other parasites e.g. pinworm, throat bot.
Maltese: Fiż-żwiemel u fil-ponis, l-għoti orali tal-monoprodotti huwa intiż għall-kura ta' strongyles kbar u żgħar, askaride u parassiti oħrajn eż. pinworm, throat bot.
English: In sheep, subcutaneous administration of the injectable products is intended for the treatment and prevention of gastro-intestinal nematodes, respiratory tract nematodes, larvae of bot fly and mange mites.
Maltese: Fin-ngħaġ, l-għoti taħt il-ġilda tal-prodotti injetabbli huwa intiż għall-kura u l-prevenzjoni ta' nematodi gastrointestinali, nematodi tal-apparat respiratorju, larva ta' qurdien u dud bil-marda tal-ġilda.
English: Cydectin 0,1% Moxidectin Oral solution 1 mg/ml
Maltese: Cydectin 0,1% Moxidectin Soluzzjoni li tittieħed mill-ħalq
English: The CVMP considered the study as reliable and concluded that moxidectin fulfils the B criterion for bioaccumulation (BCFKL 2543 l/kg) as specified in CVMP guideline on the assessment of PBT/vPvB substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012), i.e. the bioconcentration factor in aquatic species is higher than 2000.
Maltese: PBT/vPvB fi prodotti mediċinali veterinarji (EMA/CVMP/ERA/52740/2012), jiġifieri l-fattur ta' bijokonċentrazzjoni fi speċi akwatiċi huwa ogħla minn 2000.
English: • the CVMP considered that a targeted sampling in the environment following the use of veterinary medicinal products as a pour-on solution containing 5 mg moxidectin per ml or as a solution for injection containing 100 mg moxidectin per ml in beef cattle in pasture animals is necessary to obtain a better understanding of the actual environmental exposure;
Maltese: • is-CVMP ikkunsidra li huwa meħtieġ kampjunar tal-mira fl-ambjent wara l-użu ta' prodotti mediċinali veterinarji bħala soluzzjoni li titferra' li fiha 5 mg moxidectin għal kull ml jew bħala soluzzjoni għall-injezzjoni li fiha 100 mg moxidectin għal kull ml fil-gnieddes f'annimali li jirgħu sabiex jinkiseb fehim aħjar tal-esponiment ambjentali attwali;
English: Given the limited number of different classes of end-/ectoparasiticides and the responsible use principle requiring the use of substances of different classes of antiparasitics for the control of parasitoses in order to reduce the risk of resistance development, veterinary medicinal products containing moxidectin are considered an important therapeutic option.
Maltese: Minħabba n-numru limitat ta' klassijiet differenti ta' end-/ektoparassitiċidi u l-prinċipju tal-użu responsabbli li jeħtieġ l-użu ta' sustanzi ta' klassijiet differenti ta' antiparassitiċi għall-kontroll talparasitożijiet sabiex jitnaqqas ir-riskju ta' żvilupp għar-reżistenza, prodotti mediċinali veterinarji li fihom moxidectin jitqiesu bħala għażla terapewtika importanti.
English: The marketing authorisation holders' conclusion that the likelihood of persistence, bioaccumulation and toxicity occurring under realistic conditions is low, is based on theoretical considerations, as outlined above.
Maltese: Il-konklużjoni tad-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq li l-probabbiltà li jkun hemm persistenza, bijoakkumulazzjoni u tossiċità taħt kondizzjonijiet realistiċi hija baxxa, hija bbażata fuq kunsiderazzjonijiet teoretiċi, kif spjegat hawn fuq.
English: Iceland Continental Farmaceutica Rue Laid Burniat 1,
Maltese: L-Iżlanda Continental Farmaceutica Rue Laid Burniat 1,