FrancophonIA/ELRC3.0 huggingface dataset:
English: Crustaceans (Water fleas)
Maltese: Krustaċji (Qurdien talilma)
English: The effect on the reproduction of Eisenia foetida was investigated in a GLP compliant study according to OECD guideline 22215.
Maltese: L-effett fuq ir-riproduzzjoni ta' Eisenia foetida ġie investigat fi studju konformi mal-GLP skont il-linja gwida 222 tal-OECD15.
English: The subacute toxicity was investigated in a GLP compliant study according to US FDA Environmental Assessment Technical Assistance Document no. 4.1214.
Maltese: It-tossiċità subakuta ġiet investigata fi studju konformi mal-GLP skont id-Dokument ta' Assistenza Teknika għal Valutazzjoni Ambjentali tal-FDA tal-Istati Uniti nru. 4.1214.
English: EC50: the concentration which results in 50% of the test species individuals being adversely affected, i.e. both mortality and sub-lethal effects.
Maltese: EC50: il-konċentrazzjoni li tirriżulta f'50 % tal-individwi ta' speċi tat-test li jiġu affettwati b'mod avvers, jiġifieri kemm effetti tal-mortalità u subletali.
English: Based on the available data high toxicity of moxidectin to aquatic and sediment organisms has been identified, i.e. a NOEC of 3.1 ng/l for Daphnia magna, a NOEC of 3.2 ng/l for fish and a NOEC of 111 µg/kg dry weight for chironomids.
Maltese: Abbażi tad-dejta disponibbli, ġiet identifikata tossiċità għolja ta' moxidectin għal organiżmi akwatiċi u tas-sediment, jiġifieri NOEC ta' 3.1 ng/l għal Daphnia magna, NOEC ta' 3.2 ng/l għall-ħut u NOEC ta' 111 µg/kg piż niexef għal kironomidi.
English: Transcutaneous solution
Maltese: Soluzzjoni transkutanja
English: These exclusion times are based on refined risk quotients with refined PEC values.
Maltese: Dawn ilħinijiet ta' esklużjoni huma bbażati fuq kwozjenti tar-riskju raffinati b'valuri PEC raffinati.
English: 3 OECD guideline for the testing of chemicals no. 305: Bioaccumulation in Fish: Aqueous and Dietary Exposure - link organism were in total sixty (60) rainbow trout (Oncorhynchus mykiss) with a mean total length of 5.6 cm and a mean wet weight of 1.738 g at the start of the test.
Maltese: L-organiżmi tat-test kienu b'kollox sittin (60) trota qawsalla (Oncorhynchus mykiss) b'tul totali medju ta' 5.6 cm u b'piż niedi medju ta' 1.738 g fil-bidu tat-test.
English: The 21-day LC50 for parental mortality (based on immobilisation) was determined to be 0.028 μg/l, with complete mortality observed at the highest mean measured test concentration of 0.14 μg/l.
Maltese: L-LC50 ta' 21 jum għal mortalità ġenitrika (ibbażata fuq lNOEC ta' moxidectin għar-riproduzzjoni fl-immobilizzazzjoni) ġiet determinata li kienet 0.028 μg/l, b'mortalità kompluta li ġiet osservata flogħla konċentrazzjoni tat-test imkejla medja ta' 0.14 μg/l.
English: Overall the CVMP considered that moxidectin fulfils the T criterion based on the high toxicity of moxidectin to aquatic organisms, i.e. a NOEC of 3.1 ng/l for Daphnia magna and a NOEC of 3.2 ng/l for fish (Pimephales promelas).
Maltese: B'mod ġenerali, is-CVMP ikkunsidra li moxidectin jissodisfa l-kriterju T abbażi tat-tossiċità għolja ta' moxidectin għal organiżmi akwatiċi, jiġifieri NOEC ta' 3.1 ng/l għal Daphnia magna u NOEC ta' 3.2 ng/l għall-ħut (Pimephales promelas).
English: Transformation of moxidectin in soil will indeed be faster at higher temperatures but even at 20 °C, as in the laboratory degradation study in soil, moxidectin was shown to be persistent in sandy soil.
Maltese: It-trasformazzjoni ta' moxidectin se tkun tabilħaqq aktar mgħaġġla f'temperaturi ogħla iżda anki f'20 C, bħal fl-istudju dwar iddegradazzjoni tal-laboratorju fil-ħamrija, intwera li moxidectin huwa persistenti f'ħamrija ramlija.
English: Moxidectin Gel oral
Maltese: Moxidectin Soluzzjoni orali
English: An EC50 for immobilisation was established as 26 ng/l based on geometric mean of measured test concentrations.
Maltese: Ġiet stabbilita EC50 għall-immobilizzazzjoni bħala 26 ng/l abbażi ta' medja ġeometrika ta' konċentrazzjonijiet tat-test imkejla.
English: A comprehensive risk assessment for moxidectin and dung fauna has been provided.
Maltese: Ġiet ipprovduta valutazzjoni tar-riskju komprensiva għal moxidectin u l-fawna tad-demel.
English: The threshold specified in the CVMP guideline on the assessment of PBT/vPvB substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012) is NOEC or EC10 for marine or freshwater organisms less than 0.01 mg/l.
Maltese: PBT/vPvB fi prodotti mediċinali veterinarji (EMA/CVMP/ERA/52740/2012) huwa NOEC jew EC10 għal organiżmi tal-baħar jew tal-ilma ħelu ta' inqas minn 0.01 mg/l.
English: The first study with the common carp (Cyprinus carpio), was performed in accordance with OECD guideline no. 2039 and a LC50 value for moxidectin was established as 0.11 µg/l based on geometric mean of measured test concentrations.
Maltese: L-ewwel studju bil-karpjun komuni (Cyprinus carpio), sar f'konformità mal-linja gwida nru 203 tal-OECD9 u ġie stabbilit valur LC50 għal moxidectin bħala 0.11 µg/l abbażi ta' medja ġeometrika ta' konċentrazzjonijiet tat-test imkejla.
English: From a clinical point of view avermectins are considered the most suitable treatment alternative to moxidectin, given the similar spectrum of activity against internal and external parasitic species in cattle, sheep and horses.
Maltese: Minn lenti klinika, avermectins jitqiesu l-aktar trattament alternattiv xieraq għal moxidectin, minħabba l-ispettru ta' attività simili kontra speċi ta' parassitiċi interni u esterni fil-frat, fin-ngħaġ u fiż-żwiemel.
English: • the CVMP considered that based on the available data high toxicity of moxidectin to aquatic and sediment organisms and a risk for dung fauna have been identified;
Maltese: • is-CVMP ikkunsidra li abbażi tad-dejta disponibbli ġew identifikati tossiċità għolja ta' moxidectin għal organiżmi akwatiċi u tas-sediment u riskju għall-fawna tad-demel;
English: 3690 (cattle, solution for injection containing 100 mg moxidectin per ml)
Maltese: 3690 (frat, soluzzjoni għall-injezzjoni li fiha 100 mg moxidectin għal kull ml)
English: The following findings should be reported:
Maltese: Il-kondizzjonijiet li ġejjin għandhom jiġu ssodisfati mid-detenturi tal-awtorizzazzjoni għat-tqegħid fissuq kollha:
English: The NOEC for fry survival, the most sensitive study endpoint, was established as 3.2 ng/l.
Maltese: L-NOEC għas-sopravivenza tal-qixx, l-aktar end-point tal-istudju sensittiv, ġie stabbilit bħala 3.2 ng/l.
English: With regards to the metabolism in the target animal, the lack of accumulation in mammals does not automatically exclude the potential for accumulation in fish; in general the activity of enzymes involved in the transformation of xenobiotics decrease at lower trophic levels as stated in the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005
Maltese: Fir-rigward talmetaboliżmu fl-annimal fil-mira, in-nuqqas ta' akkumulazzjoni fil-mammiferi ma jeskludix awtomatikament il-potenzjal għal akkumulazzjoni fil-ħut; b'mod ġenerali, l-attività tal-enzimi involuti fit-trasformazzjoni tal-ksenobjotiċi titnaqqas f'livelli trofiċi aktar baxxi kif iddikjarat fil-linja gwida tasCVMP dwar valutazzjoni tal-impatt ambjentali għal prodotti mediċinali veterinarji f'appoġġ tal-linji gwida ta' VICH GL6 u GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1)4.
English: • Concentrations of moxidectin in the different target matrices.
Maltese: • Konċentrazzjonijiet ta' moxidectin f'matriċi fil-mira differenti.
English: PECsurfacewater direct (ng/l)
Maltese: PECskol tal-ilma tal-wiċċ (ng/l)
English: The degradation of [3H]-moxidectin was investigated under aerobic conditions at 20±2 ºC for 120 days in the dark, following application at a nominal rate of 0.01 mg/kg soil to four different types of soil (i.e. sandy loam, sand, clay loam and loam with organic carbon content of 1.0%, 0.4%, 2.0% and 4.5%,
Maltese: 307: Aerobic and Anaerobic Transformation in Soil - link dlam, wara applikazzjoni f'rata nominali ta' 0.01 mg/kg ħamrija lil erba' tipi differenti ta' ħamrija (jiġifieri, trab ġuġlieni ramli, ramel, trab ġulġlieni tafli u trab ġulġlieni b'kontenut ta' karbonju organiku ta' 1.0 %, 0.4 %, 2.0 % u 4.5 %, rispettivament, u kontenut ta' tira aġġustat għal 50 % tal-kapaċità taż-żamma massima tal-ilma).
English: In cattle, topical administration of the pour-on combination products (moxidectin in combination with triclabendazole) is intended for the treatment of gastro-intestinal nematodes, respiratory tract nematodes, trematode (fluke) and certain arthropod infestations.
Maltese: Fil-frat, l-għoti topiku tal-prodotti kkombinati li jitferrgħu (moxidectin flimkien ma' triclabendazole) huwa intiż għall-kura ta' nematodi gastrointestinali, nematodi tal-apparat respiratorju, trematodi (fluke) u ċerti infestazzjonijet ta' artropodi.
English: Taking into account a default DT50_sediment of 1000 days (as a water/sediment study was not available) one marketing authorisation holder calculated the PECsediment_plateau to be 55.8 µg/kg dry weight.
Maltese: 1000 jum (peress li ma kienx hemm disponibbli studju tal-ilma/tas-sediment) detentur talawtorizzazzjoni għat-tqegħid fis-suq wieħed ikkalkula li l-PECsediment_plateau hija 55.8 µg/kg piż tal-ġisem.
English: Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance.
Maltese: Moxidectin jissodisfa l-kriterji għal sustanza persistenti, bijoakkumulattiva u tossika (PBT) (ħafna).
English: Daphnids
Maltese: Dafnidi
English: For cattle, the highest PECs for surface water were 0.436 ng/l for run-off after subcutaneous route of administration (injectable products) and 0.219 ng/l for direct excretion into surface waters after topical (cutaneous) route of administration (pour-on products).
Maltese: 436 ng/l għal skol wara għoti taħt il-ġilda (prodotti injetabbli) u 0.219 ng/l għal eskrezzjoni diretta fuq ilmijiet tal-wiċċ wara metodu ta' amministrazzjoni jingħata topiku (fuq il-ġilda) (prodotti li jitferrgħu).
English: Veterinary medicinal products containing moxidectin as a sole active substance or in combination with another antiparasitic active substance(s) (e.g. triclabendazole or praziquatel) are widely used for the treatment and prevention of internal and external parasitic infections in foodproducing animals and companion animals.
Maltese: Prodotti mediċinali veterinarji li fihom moxidectin bħala l-unika sustanza attiva jew flimkien ma' sustanza(i) attiva(i) antiparasitika(ċi) oħra(jn) (eż. triclabendazole jew praziquatel) jintużaw ħafna għall-kura u l-prevenzjoni ta' infezzjonijiet parasitiċi interni u esterni f'annimali li jipproduċu l-ikel u f'annimali u f'annimali tal-kumpanija.
English: Toxicity the conditions of the study, the LC50 value for moxidectin was established as 0.16 µg/l.
Maltese: Taħt il-kondizzjonijiet tal-istudju, il-valur LC50 għal moxidectin ġie stabbilit bħala 0.16 µg/l.
English: On the other hand, there is evidence from literature (Prichard et al., 2012)18 that the resistance against avermectins and moxidectin is not always genetically identical, which implies that avermectin resistant parasite strains can be successfully treated with moxidectin.
Maltese: Min-naħa l-oħra, hemm evidenza mil-letteratura (Prichard et al., 2012)18 li r-reżistenza kontra avermectins u moxidectin ma tkunx dejjem identika ġenetikament, li timplika li razez talparassiti reżistenti għal avermectin jistgħu jiġu ttrattati b'suċċess b'moxidectin.
English: It is noted that according to the CVMP reflection paper on the authorisation of VMPs containing PBT or vPvB substances (EMA/CVMP/448211/2015)17 further measures intended to ensure responsible use of antiparasitic veterinary medicinal products, for example, targeted selective treatment of individual animals on farm level, are considered to limit environmental exposure.
Maltese: PBT jew vPvB (EMA/CVMP/448211/2015)17 jiġu kkunsidrati aktar miżuri intiżi li jiżguraw użu responsabbli ta' prodotti mediċinali veterinarji antiparassitiċi, pereżempju, trattament selettiv fil-mira ta' annimali individwali fuq livell ta' razzett, sabiex jiġi llimitat esponiment ambjentali.
English: The respective risk quotient for moxidectin is 0.01 which is below the trigger value of 1.
Maltese: Il-kwozjent tar-riskju rispettiv għal moxidectin huwa 0.01 li huwa taħt il-valur ta' skattar ta' 1.
English: The worst-case DT50 was 296.6 days at 12 °C, extrapolated from 139 days at 20 °C in sandy soil.
Maltese: L-agħar xenarju ta' DT50 kien ta' 296.6 jiem f'12 C, estrapolat minnn 139 jum f'20 C f'ħamrija ramlija.
English: Based on the [3H]-residues as [3H]-moxidectin in the test media, the bioconcentration factors for whole fish tissue were as follows:
Maltese: Abbażi tar-residwi [3H] bħala [3H]-moxidectin fil-media tat-test, il-fatturi ta' bijokonċentrazzjoni għattessuti kollha tal-ħut kienu kif ġej:
English: Considering further PEC-refinement (FOCUS SW - calculations and excretion pattern evaluation for risk mitigation measures) the maximum PEC values for the relevant environmental compartments are summarised as follows:
Maltese: Meta jiġi kkunsidrat aktar raffinament ta' PEC (FOCUS SW - kalkoli u valutazzjoni tat-tendenza taleskrezzjoni għal miżuri ta' mitigazzjoni tar-riskji) il-valuri PEC massimi għall-kompartimenti ambjentali relevanti huma miġburin fil-qosor kif ġej:
English: In horses and ponies, oral administration of the combination products (moxidectin in combination with praziquantel) is intended for the treatment of large and small strongyles, ascarids, tapeworm and other parasites e.g. pinworm, throat bot.
Maltese: Fiż-żwiemel u fil-ponis, l-għoti orali tal-prodotti kkombinati (moxidectin flimkien ma' praziquantel) huwa intiż għall-kura ta' strongyles kbar u żgħar, ascarids, tapeworm u parassiti oħrajn eż. pinworm, throat bot.
English: Earthworms
Maltese: InNetherlands
English: As the mean recovery of moxidectin at the end of the study (63 days) was less than 50%, a value of 63 days is used as half-life value of moxidectin.
Maltese: Peress li lirkupru medju ta' moxidectin fl-aħħar tal-istudju (63 jum) kien inqas minn 50 %, jintuża valur ta' 63 jum bħala l-valur ta' nofs ħajja ta' moxidectin.
English: *-PEC calculation for direct excretion by sheep is not necessary as per CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) but was calculated by a marketing authorisation holder to cover every possible scenario.
Maltese: *-il-kalkolu tal-PEC għal eskrezzjoni diretta min-ngħaġ mhuwiex meħtieġ skont il-linja gwida tas-CVMP dwar valutazzjoni tal-impatt ambjentali għal prodotti mediċinali veterinarji li tapoġġja l-linja gwida tal-VICH GL6 u GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) iżda ġie kkalkulat minn detentur tal-awtorizzazzjoni għat-tqegħid fis-suq li jkopri kull xenarju possibbli.
English: The marketing authorisation holders argued that under realistic conditions, aquatic exposure to moxidectin will be either unlikely or extremely low due to strong adsorption of moxidectin onto soil or will not be maintained longer than 24 hours due to rapid partitioning into sediment.
Maltese: Id-detenturi talawtorizzazzjoni għat-tqegħid fis-suq argumentaw li taħt kondizzjonijiet realistiċi, l-esponiment akwatiku għal moxidectin se jkun jew mhux probabbli jew baxx ħafna minħabba adsorbiment qawwi ta' moxidectin fil-ħamrija jew mhux se jinżamm aktar minn 24 siegħa minħabba partizzjoni mgħaġġla fissediment.
English: In a second study with Raphidocelis subcapitata over 72 hours, no inhibition in the growth was noted at 86.9 µg/l, the highest concentration tested.
Maltese: Fit-tieni studju b'Raphidocelis subcapitata li dam 72 siegħa, ma ġiet innutata l-ebda inibizzjoni fittkabbir b'86.9 µg/l, l-ogħla konċentrazzjoni ttestjata.
English: Moxidectin is an anthelmintic macrocyclic lactone endectocide that is widely used in veterinary medicine.
Maltese: Moxidectin huwa endektoċid latton makrocikliku antelmintiku li jintuża ħafna fil-mediċina veterinarja.
English: C. For veterinary medicinal products listed in Annex I as oral solution and administered to sheep containing 1 mg moxidectin per ml or 1 mg moxidectin and 50 mg triclabendazole per ml
Maltese: Għal prodotti mediċinali veterinarji elenkati fl-Anness I bħala soluzzjoni orali u li jingħataw lin-ngħaġ li fihom 1 mg moxidectin għal kull ml jew 1 mg moxidectin u 50 mg triclabendazole għal kull ml
English: As exposure of aquatic organism is unlikely to occur, the toxicity will be reduced significantly.
Maltese: Peress li mhuwiex probabbli li jkun hemm esponiment ta' organiżmu akwatiku, it-tossiċità se titnaqqas ħafna.
English: 0.058 (cattle, solution for injection containing 10 mg moxidectin per ml)
Maltese: 0.058 (frat, soluzzjoni għall-injezzjoni li fiha 10 mg moxidectin għal kull ml)
English: Pasture Scenarios
Maltese: Bijoakkumulazzjoni
English: • Different target matrices that should be considered for the occurrence of moxidectin such as dung, surface water/suspended particles, sediment and soil.
Maltese: • Matriċi fil-mira differenti li għandhom jiġu kkunsidrati għal meta jidher moxidectin bħal demel, ilma tal-wiċċ/partiċelli sospiżi, sediment u ħamrija.
English: Direct therapeutic benefits
Maltese: Benefiċċji terapewtiċi diretti
English: In the context of marketing authorisation applications submitted to the German national competent authority, Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, under Article 13 of Directive 2001/82/EC as amended, i.e., a generic application, for veterinary medicinal products containing moxidectin, as pour-on solution for cattle, a study on bioaccumulation was provided.
Maltese: Fil-kuntest tal-applikazzjonijiet għall-awtorizzazzjoni għat-tqegħid fis-suq ippreżentati lill-awtorità kompetenti nazzjonali Ġermaniża, Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, skont l-Artikolu 13 tad-Direttiva 2001/82/KE kif emendat, jiġifieri, applikazzjoni ġenerika, għal prodotti mediċinali veterinarji li fihom moxidectin, bħala soluzzjoni li titferra' għal frat, ġie pprovdut studju dwar il-bijoakkumulazzjoni.
English: 7642NN Wierden The Netherlands
Maltese: 7642NN
English: A tiered approach was applied considering the CVMP draft guideline on the higher tier testing of veterinary medicinal products to dung fauna (EMA/CVMP/ERA/409350/2010)13.
Maltese: Ġie applikat approċċ b'livelli meta ġiet ikkunsidrata l-linja gwida abbozz tas-CVMP dwar l-ittestjar ta' livell ogħla ta' prodotti mediċinali veterinarji għal fawna tad-demel (EMA/CVMP/ERA/409350/2010)13.
English: CYDECTIN 2% sheep Moxidectin Solution for injection
Maltese: CYDECTIN 2% sheep Moxidectin Soluzzjoni għallinjezzjoni
English: 18,92 mg/g Horse
Maltese: 18,92 mg/g Żiemel
English: Avermectins have a very similar broad spectrum of activity, but partly achieved through different mode of action on glutamate-gated chloride channel receptors in nematode and arthropod cells, and efflux pathways at molecular levels.
Maltese: Avermectins għandhom spettru ta' attività wiesgħa simili ħafna, iżda parzjalment miksub minn mod ta' azzjoni differenti dwar riċetturi talkanal ta' glutamate-gated chloride f'ċelluli nematodi u artropodi, u passaġġi ta' effluss f'livelli
English: A. For veterinary medicinal products listed in Annex I as pour-on solution and administered to cattle containing 5 mg moxidectin per ml or 5 mg moxidectin and 200 mg triclabendazole per ml
Maltese: Għal prodotti mediċinali veterinarji elenkati fl-Anness I bħala soluzzjoni li titferra' u li jingħataw lil frat li fihom 5 mg moxidectin għal kull ml jew 5 mg moxidectin u 200 mg triclabendazole għal kull ml
English: The second study was performed in accordance with the US FDA Environmental Assessment Technical Assistance Document no. 4.087 which is comparable to the current OECD methods.
Maltese: It-tieni studju sar f'konformità mad-Dokument ta' Assistenza Teknika għal Valutazzjoni Ambjentali tal-FDA tal-Istati Uniti nru 4.087 li huwa kumparabbli mal-metodi attwali tal-OECD.
English: CYDECTIN SOLUCIÓN INYECTABLE AL 1% PARA GANADO OVINO
Maltese: INYECTABLE AL 1% PARA GANADO OVINO
English: 325 (cattle, pour-on solution containing 5 mg moxidectin per ml)
Maltese: 325 (frat, soluzzjoni li titferra' li fiha 5 mg moxidectin għal kull ml)
English: Based on the available information, Germany considered that the active substance moxidectin may have persistent, bioaccumulative and toxic (PBT) properties in accordance with the CVMP guideline on the assessment of PBT or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012)1.
Maltese: Abbażi tal-informazzjoni disponibbli, il-Ġermanja kkunsidrat li s-sustanza attiva moxidectin jista' jkollha proprjetajiet persistenti, bijoakkumulattivi u tossiċi (PBT) skont il-linja gwida tas-CVMP dwar il-valutazzjoni ta' PBT jew sustanzi b'persistenza għolja u bijoakkumulazzjoni għolja (vPvB) fi prodotti mediċinali veterinarji (EMA/CVMP/ERA/52740/2012)1.
English: A number of GLP compliant laboratory studies on toxicity in aquatic invertebrates, fish, green algae, sediment invertebrates and dung insects were provided.
Maltese: Ġew ipprovduti għadd ta' studji tal-laboratorju konformi mal-GLP dwar it-tossiċità f'invertebrati akwatiċi, ħut, alga ħadra, invertebrati tas-sediment u insetti tad-demel.
English: Belgium Zoetis Belgium SA Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgium
Maltese: Il-Belġju Zoetis Belgium SA Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgium
English: Slovenia Continental Farmaceutica, Rue Laid Burniat 1,
Maltese: Is-Slovenja Continental Farmaceutica, Rue Laid Burniat 1,
English: Delete, where applicable, the following sentence: ‘Risk to dung fauna may be reduced by avoiding treatment that coincides with periods of local high activity of dung beetles.
Maltese: Fejn applikabbli, neħħi s-sentenza li ġejja:“Ir-riskju għall-fawna tad-demel jista' jitnaqqas billi jiġi evitat trattament li jikkoinċidi ma' perjodi ta' attività għolja lokali ta' ħanfus tad-demel.
English: Regarding the inherent toxicity of moxidectin to aquatic organisms, the marketing authorisation holders considered that acute effects as in the acute toxicity test with D. magna, i.e. effects after 48 hours under continuous exposure, are not transferable to the field situation.
Maltese: Fir-rigward tattossiċità inerenti ta' moxidectin lil organiżmi akwatiċi, id-detenturi tal-awtorizzazzjoni għat-tqegħid fissuq ikkunsidraw li effetti akuti bħal fit-test ta' tossiċità akuta b'D. magna, jiġifieri effetti wara 48 siegħa taħt esponiment kontinwu, mhumiex trasferibbli għas-sitwazzjoni tal-post.
English: • the CVMP considered that veterinary medicinal products containing moxidectin to be administered to cattle, sheep and horses as pour-on, injectable and oral formulations are effective veterinary medicines in the treatment of the internal and external parasites in cattle, sheep and horses;
Maltese: • is-CVMP ikkunsidra li prodotti mediċinali veterinarji li fihom moxidectin li għandhom jingħataw lil frat, ngħaġ u żwiemel bħala formulazzjonijiet li jitferrgħu, injettabbli u orali huma mediċini veterinarji effettivi fit-trattament ta' parassiti interni u esterni fil-frat, fin-ngħaġ u fiż-żwiemel;
English: A comprehensive risk assessment for dung organisms was also provided, resulting in risk quotients (PEC/PNEC) of >5000 and >1000 for dung flies and dung beetles, respectively, indicating a risk for dung fauna.
Maltese: Ġiet ipprovduta wkoll valutazzjoni tar-riskju komprensiva għal organiżmi tad-demel li tirriżulta fi kwozjenti tar-riskju (PEC/PNEC) ta' >5000 u >1000 għal dubbien tad-demel u ħanfus tad-demel, rispettivament, li jindikaw riskju għall-fawna tad-demel.
English: In cattle, topical administration of the pour-on monoproducts (moxidectin only) is intended for the treatment of gastro-intestinal nematodes, respiratory tract nematodes, warble grubs, lice, mange mites and horn flies.
Maltese: Fil-frat, l-għoti topiku tal-monoprodotti li jitferrgħu (moxidectin biss) huwa intiż għall-kura ta' nematodi gastrointestinali, nematodi tal-apparat respiratorju, larva tal-warble, qamel, dud bil-marda tal-ġilda u dubbien tal-qarn.