FrancophonIA/ELRC3.0 huggingface dataset:
English: Zoely is a combined contraceptive pill that contains two active substances, nomegestrol acetate (a progestogen) and estradiol (an oestrogen).
Maltese: Zoely huwa pillola kontraċettiva kkombinata li fiha żewġ sustanzi attivi, aċetat tan-nomegestrolu (proġestoġen) u estradijolu (estroġenu).
English: Zoely comes in blisters containing 28 tablets (24 white tablets followed by 4 yellow tablets), which are taken in sequence using stickers to identify the days of the week for each tablet.
Maltese: Zoely jiġi f'folji li fihom 28 pillola (24 pilloli bojod segwiti minn 4 pilloli sofor), li jittieħdu f'sekwenza permezz ta' stickers biex jindikaw il-ġranet tal-ġimgħa għal kull pillola.
English: The Pearl Index is a standard way of measuring the effectiveness of contraceptives, which measures how many unwanted pregnancies occur in 100 women-years (corresponding to 1,300 menstrual cycles).
Maltese: L-Indiċi Pearl huwa mod standard ta' kif tkejjel l-effikaċja tal-kontraċettivi, li jkejjel l-okkorrenza ta' tqaliet mhux mixtieqa f'100 mara-sena (li jikkorrispondi għal 1,300 ċiklu mestrwali).
English: What is Zoely?
Maltese: X'inhu Zoely?
English: The participants were given either Zoely or another contraceptive pill containing drospirenone and ethinyl estradiol for one year (13 menstrual cycles).
Maltese: Il-parteċipanti ngħataw jew Zoely jew pillola kontraċettiva oħra li fiha drospirenone u ethinyl estradiol għal sena (13-il ċiklu mestrwali).
English: What is the risk associated with Zoely?
Maltese: X'inhu r-riskju assoċjat ma' Zoely?
English: The main measure of effectiveness was the number of women aged 18 to 35 who became pregnant during or shortly after treatment, expressed in terms of a pregnancy rate using the ‘Pearl Index'.
Maltese: Il-kejl ewlieni tal-effikaċja kien in-numru ta' nisa bejn it-18 u l-35 sena li ħarġu tqal matul jew ftit wara l-kura, espressa f'termini ta' rata ta' tqala permezz tal-‘Indiċi Pearl'.
English: A lower Pearl Index represents a lower chance of getting pregnant.
Maltese: Indiċi Pearl baxx jirrappreżenta ċans aktar baxx ta' tqala.
English: Estradiol is the same as a hormone naturally produced by the ovaries during a menstrual cycle.
Maltese: Estradiol huwa l-istess bħal ormon prodott b'mod naturali millovarji matul ċiklu mestrwali.
English: It should not be used in women who have pancreatitis (inflammation of the pancreas), severe liver problems, liver tumours or a history of liver tumours, certain types of cancer, or abnormal bleeding from the genital area whose cause has not been diagnosed.
Maltese: Ma għandux jintuża f'nisa li jbatu bil-pankreatite (infjamazzjoni tal-frixa), problemi serji fil-fwied, tumuri fil-fwied jew passat b'tumuri filfwied, ċerti tipi ta' kanċer, jew fsada anormali mill-parti ġenitali li l-kawża tagħha ma ġitx dijanjostikata.
English: How has Zoely been studied?
Maltese: Kif ġie studjat Zoely?
English: No clinical study data on Zoely are available in adolescents under 18 years old.
Maltese: Ma hija disponibbli l-ebda data minn studju kliniku dwar Zoely fuq adolexxenti taħt it-18-il sena.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoely on 27 July 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zoely fis-27 ta' Lulju 2011.
English: The most frequent side effects with Zoely (seen in more than 1 user in 10) are acne and changes to menstrual periods (e.g. absence or irregularity).
Maltese: L-effetti sekondarji l-aktar frekwenti b'Zoely (li dehru f'aktar minn utent 1 minn kull 10) huma l-akne u tibdil fil-mestrwazzjoni (eż. assenza jew irregolarità).
English: A risk management plan has been developed to ensure that Zoely is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Zoely jintuża bl-aktar mod sigur possibbli.
English: For the full list of all side effects reported with Zoely, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Zoely, ara l-fuljett ta' tagħrif.
English: The CHMP decided that the benefits of Zoely are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Zoely huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Why has Zoely been approved?
Maltese: Għaliex ġie approvat Zoely?
English: Nomegestrol acetate is derived from the hormone called progesterone which is also produced by the ovaries during a menstrual cycle.
Maltese: Nomegestrol acetate huwa derivat mill-ormon imsejjaħ proġesteron li huwa wkoll prodott mill-ovarji matul ċiklu mestrwali.
English: How does Zoely work?
Maltese: Liema benefiċċju wera Zoely matul l-istudji?
English: One tablet a day is taken for as long as contraception is required, starting with an active tablet on the first day of the cycle.
Maltese: Pillola waħda kuljum li tittieħed sakemm tkun meħtieġa l-kontraċezzjoni, li tibda b'pillola attiva flewwel ġurnata taċ-ċiklu.
English: What measures are being taken to ensure the safe and effective use of Zoely?
Maltese: X'miżuri qed jitteħdu biex jiġi żgurat l-użu sigur u effikaċi ta' Zoely?
English: de Europa 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spain
Maltese: Avda. de Europa 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spain
English: 6100 (horse, oral)
Maltese: 6100 (żiemel, orali)
English: Ireland Chanelle Pharmaceuticals Manufacturing Ltd.
Maltese: L-Irlanda Chanelle Pharmaceuticals Manufacturing Ltd.
English: Journal for Parasitology: Drugs Drug Resistance 2:134-53.
Maltese: Drugs Drug Resistance 2:134-53.
English: 6 St. Andrew Street London EC4A 3AE United Kingdom
Maltese: Andrew Street London EC4A 3AE United Kingdom
English: Ireland Zoetis Ireland Limited 25/28 North Wall Quay Dublin 1
Maltese: L-Irlanda Zoetis Ireland Limited 25/28 North Wall Quay Dublin 1
English: Rivium Westlaan 74
Maltese: Westlaan 74
English: Daphnia magna (reproduction)
Maltese: Daphnia magna (riproduzzjoni)
English: Daphnia magna (acute)
Maltese: Daphnia magna (akuta)
English: Co. Down, BT35 6JP
Maltese: Down, BT35 6JP
English: Environmental profile of alternatives
Maltese: Profil ambjentali ta' alternattivi
English: Via Andrea Doria, 41 M 00192 Roma Italy
Maltese: Zoetis Italia S.r.l. Via Andrea Doria, 41 M 00192 Roma Italy
English: Postępu 17 B 02-676 Warszawa Poland
Maltese: 02-676 Warszawa
English: Ireland Norbrook Laboratories Limited Station Works Newry
Maltese: L-Irlanda Norbrook Laboratories Limited Station Works Newry
English: Germany CC-Pharma GmbH In den Feldern 2
Maltese: Il-Ġermanja CC-Pharma GmbH In den Feldern 2
English: Germany Continental Farmaceutica s.p.r.
Maltese: Il-Ġermanja Continental Farmaceutica s.p.r.
English: Mineralisation (evolution of 14CO2) accounted for up to 5% of the applied radioactivity.
Maltese: Il-mineralizzazzjoni (evoluzzjoni ta' 14CO2) ammontat għal 5 % tar-radjuattività applikata.
English: Zoetis Polska Sp. z o. o. ul.
Maltese: Il-Polonja Zoetis Polska Sp. z o. o.
English: Zoetis Österreich GmbH Floridsdorfer Hauptstrasse 1 1210 Wien
Maltese: L-Awstrija Zoetis Österreich GmbH Floridsdorfer Hauptstrasse 1 1210 Wien
English: Germany Zoetis Deutschland GmbH Schellingstr.
Maltese: Il-Ġermanja Zoetis Deutschland GmbH Schellingstr.
English: Persistence
Maltese: Persistenza
English: ZOETIS HELLAS Mesogeion 243 154 51 Neo Psixiko Athens
Maltese: 154 51 Neo Psixiko Athens
English: Horse and Pony
Maltese: Żiemel u Poni
English: Rev.1)4.
Maltese: IV).
English: Germany Zoetis Deutschland GmbH Schellingstraße 1
Maltese: Il-Ġermanja Zoetis Deutschland GmbH Schellingstraße 1
English: 11 OECD guideline for the testing of chemicals no. 210: Fish, Early-life Stage Toxicity Test - link 12 OECD guideline for the testing of chemicals no. 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment - link 13 CVMP draft guideline on the higher tier testing of veterinary medicinal products to dung fauna
Maltese: Fish, Early-life Stage Toxicity Test - link 12 OECD guideline for the testing of chemicals no. 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment - link 13 CVMP draft guideline on the higher tier testing of veterinary medicinal products to dung fauna
English: Algae
Maltese: Alga
English: The EC50 and the NOEC were established as >86.9 µg/l and 86.9 µg/l.
Maltese: L-EC50 u l-NOEC ġew stabbiliti bħala >86.9 µg/l u 86.9 µg/l.
English: Zoetis Česká republika, s.r.o.
Maltese: Is-Slovakkja Zoetis Česká republika, s.r.o.
English: Labelling:
Maltese: Tikkettjar:
English: Levels of radioactivity recovered in the organic soil extracts at the end of the study at day 63 ranged between 74-82%.
Maltese: Il-livelli ta' radjuattività rkuprati fl-estratti ta' ħamrija organika fl-aħħar tal-istudju f'jum 63 varjaw bejn 74-82 %.
English: The mean DT50 value was 104 days at 20 °C and 222 days normalised to 12 °C.
Maltese: Il-valur DT50 medju kien ta' 104 jiem f'20 C u 222 jum normalizzat għal 12 C.
English: Zoetis Hungary Kft. 1123 Budapest Alkotás u. 53.
Maltese: L-Ungerija Zoetis Hungary Kft. 1123 Budapest
English: The LC50 for mortality was established as 37.2 mg/kg; the corresponding NOEC was 20 mg/kg.
Maltese: L-LC50 għall-mortalità ġiet stabbilita bħala 37.2 mg/kg; l-NOEC korrispondenti kienet ta' 20 mg/kg.
English: The second study in rainbow trout (Oncorhynchus mykiss), was performed in accordance with US FDA Environmental Assessment Technical Assistance Document no. 4.1110.
Maltese: It-tieni studju fi trota qawsalla ((Oncorhynchus mykiss), sar f'konformità mad-Dokument ta' Assistenza Teknika għal Valutazzjoni Ambjentali nru 4.1110.
English: Qualitative PBT risk assessment
Maltese: Valutazzjoni tar-riskju kwalitattiva ta' PBT
English: The Netherlands
Maltese: Wierden The Netherlands
English: • Moxidectin is inherently toxic to aquatic organisms including fish.
Maltese: • Moxidectin huwa inerentement tossiku għal organiżmi akwatiċi inkluż il-ħut.
English: Route of administration
Maltese: Rotta ta ' amministrazzj oni
English: Additional benefits
Maltese: Benefiċċji addizzjonali
English: PECsediment direct (ng/kg)* 35 (sheep, solution for injection containing 20 mg moxidectin per ml)
Maltese: PECsediment dirett (ng/kg)* 35 (ngħaġ, soluzzjoni għall-injezzjoni li fiha 20 mg moxidectin għal kull ml)
English: Apart from macrocyclic lactones, established classes of antiparasitics in cattle, sheep and horses include benzimidazoles, tetrahydropyrimidines (pyrantel), imidazothiazoles (levamisole), amino-acetonitril derivates (monepantel), spiroindoles (derquantel).
Maltese: Minbarra lattoni makroċikliċi, klassijiet stabbiliti ta' antiparassitiċi fil-frat, fin-ngħaġ u fiż-żwiemel jinkludu benzimidazoles, tetrahydropyrimidines (pyrantel), imidazothiazoles (levamisole), aminoacetonitril derivates (monepantel), spiroindoles (derquantel).
English: 19,5 mg/g Horse
Maltese: 19,5 mg/g Żiemel
English: 16 CVMP reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal products (EMA/CVMP/ERAWP/409328/2010) - link with periods of local high activity of dung beetles.
Maltese: CVMP reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal products (EMA/CVMP/ERAWP/409328/2010) - link
English: The mean evolved tritiated water at day 120 (% of applied radioactivity) was 6.48%, 3.22%, 7.6% and 5.10% for the soils sandy loam, sand, clay loam and loam, respectively.
Maltese: L-ilma ttritjat medju li evolva f'jum 120 (% ta' radjuattività applikata) kien ta' 6.48 %, 3.22 %, 7.6 % u 5.10 % għall-ħamriji trab ġulġlieni ramli, ramel, trab ġulġlieni tafli u trab ġulġlieni, rispettivament.
English: The bioaccumulation study in fish was performed in accordance with the OECD guideline no. 3053 via aqueous exposure under flow-through conditions with continuous renewal of the test media at nominal [3H]-moxidectin concentrations of 0.00055 and 0.0011 μg/l (based on an acute LC50 (the concentration of a test substance which results in a 50% mortality of the test species) value of 0.11 µg/l).
Maltese: 3053 permezz ta' esponiment fl-ilma taħt kondizzjonijiet bi fluss kontinwu b'tiġdid kontinwu tal-midja tattest f'konċentrazzjonijiet nominali ta' [3H]-moxidectin ta' 0.00055 u 0.0011 μg/l (ibbażati fuq valur LC50 akut (il-konċentrazzjoni ta' sustanza tat-test li tirriżulta f'mortalità ta' 50 % tal-ispeċi tat-test) ta' 0.11 µg/l.
English: The experimental bioconcentration factor of 2543 l/kg is supported by the QSAR modelled bioconcentration factor of 2244 l/kg.
Maltese: Il-fattur ta' bijokonċentrazzjoni sperimentali ta' 2543 l/kg huwa appoġġjat mill-fattur ta' bijokonċentrazzjoni immudellat mill-QSAR ta' 2244 l/kg.
English: A study with Pseudokirchneriella subcapitata was performed over 72 hours as limit test with 0.5 mg/l corresponding to a mean measured concentration of 0.11 mg/l.
Maltese: Sar studju b'Pseudokirchneriella subcapitata li dam 72 siegħa bħala test tal-limitu b'0.5 mg/l li jikkorrispondi għal konċentrazzjoni mkejla medja ta' 0.11 mg/l.
English: It can be concluded that there is a negligible risk for secondary poisoning from moxidectin.
Maltese: Jista' jiġi konkluż li hemm riskju negliġibbli għal avvelenament sekondarju minn moxidectin.
English: Technical Assistance Document no. 4.08 Daphnia Acute Toxicity 8 OECD guideline for the testing of chemicals no. 211: Daphnia magna Reproduction Test - link 9 OECD guideline for the testing of chemicals no. 203: Fish, Acute Toxicity Test - link 10 US FDA Environmental Assessment Technical Handbook.
Maltese: Technical Assistance Document no. 4.08 Daphnia Acute Toxicity 8 OECD guideline for the testing of chemicals no. 211: Daphnia magna Reproduction Test - link is-sopravivenza u r-riproduzzjoni ta' D. magna f'konċentrazzjoni ta' 10 ng/l matul il-perjodu tat-test.
English: P. promelas (early life stages)
Maltese: P. promelas (stadji fil-ħajja bikrija)
English: The Predicted No Effect Concentrations (PNECs) derived by dividing the most sensitive endpoints (LC50/EC50) for the most sensitive standard organism by an assessment factor of 100 amount to 4.7 and 10 µg/kg dry weight for the dung fly (Musca autumnalis) and the dung beetle (Aphodius constans), respectively.
Maltese: IlKonċentrazzjonijiet ta' Bla Effett Previst (PNECs) derivati billi l-aktar end-points sensittivi (LC50/EC50) għall-aktar organiżmu standard sensittiv jiġu diviżi b'fattur ta' valutazzjoni ta' 100 jammontaw għal 4.7 u 10 µg/kg piż niexef għad-dubbien tad-demel (Musca autumnalis) u għall-ħanfus tad-demel (Aphodius constans), rispettivament.
English: CVMP reflection paper on the authorisation of veterinary medicinal products containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances (EMA/CVMP/448211/2015) - link
Maltese: bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances (EMA/CVMP/448211/2015) - link molekulari.
English: The NOEC for reproduction was determined as 0.84 mg/kg dry soil based on nominal concentrations.
Maltese: L-NOEC għar-riproduzzjoni ġiet determinata bħala 0.84 mg/kg ħamrija niexfa abbażi ta' konċentrazzjonijiet nominali.
English: The duration of the uptake (exposure) and depuration phases were 28 and 49 days, respectively.
Maltese: Id-durata tal-fażijiet tat-teħid (esponiment) u tat-tisfija kienu ta' 28 u 49 jum, rispettivament.
English: PECsediment run-off (ng/kg)
Maltese: PECskol tas-sediment (ng/kg)
English: This is supported by the non-standard degradation study in soil with an estimated DT50 of 63 days at 25 °C (= DT50 of 216.6 days normalised to 12 °C).
Maltese: Dan huwa appoġġjat mill-istudju dwar id-degradazzjoni mhux standard fil-ħamrija b'DT50 stmat ta' 63 jum b'25 C (= DT50 ta' 216.6 jiem normalizzat għal 12 °C).
English: The environmental profile of therapeutic alternatives including the group of macrocyclic lactones (ivermectin, abamectin, eprinomectin, and doramectin) and other groups of parasiticides such as organophosphates, synthetic pyrethroids and insect growth regulators has been considered based on available data.
Maltese: Ġie kkunsidrat il-profil ambjentali ta' alternattivi terapewtiċi inkluż il-grupp ta' lattoni makroċikliċi (ivermectin, abamectin, eprinomectin, u doramectin) u gruppi oħrajn ta' parassitiċidi bħal organifosfati, piretrojdi sintetiċi u regolaturi tat-tkabbir tal-insetti abbaż ta' dejta disponibbli.
English: The second biodegradation study with moxidectin was performed in three different soils (i.e. sandy loam, loam and silt loam with an organic carbon content of 0.58%, 1.39%, and 1.8%, respectively, and a moisture content maintained at 70% of the field capacity) at 25 °C under aerobic conditions for 63 days in the dark.
Maltese: It-tieni studju dwar il-bijodegradazzjoni b'moxidectin sar fi tliet ħamriji differenti (jiġifieri, trab ġulġlieni ramli, trab ġulġlieni tafli u trab ġulġlieni bil-ħama b'kontenut tal-karbonju organiku ta' 0.58 %, 1.39 %, u 1.8 %, rispettivament, u b'kontenut ta' tira li nżamm f'70 % tal-kapaċità tar-raba') f'25 C f'kondizzjonijiet aerobiċi għal 63 jum fid-dlam.
English: The marketing authorisation holders considered that degradation rates at 12 °C are overly conservative and do not reflect likely degradation rates under normal conditions of use.
Maltese: Id-detenturi tal-awtorizzazzjoni għattqegħid fis-suq ikkunsidraw li r-rati ta' degradazzjoni f'12 °C huma wisq konservattivi u ma jirriflettux ir-rati ta' degradazzjoni probabbli taħt kundizzjonijiet tal-użu normali.
English: Data were provided for laboratory (Tier A), extended laboratory with incurred residues (Tier B) and field studies (Tier C).
Maltese: Ġiet ipprovduta dejta għal studji tal-laboratorju (Livell A), tal-laboratorju estiżi b'residwi mġarrba (Livell B) u fuq ilpost (Livell Ċ).
English: EQUEST GEL ORALE Moxidectin Oral gel
Maltese: EQUEST GEL ORALE Moxidectin Ġell orali
English: The study was conducted over a 28-day post-hatch period under continuous flow conditions.
Maltese: Listudju sar fuq perjodu ta' wara t-tifqis ta' 28 jum taħt kondizzjonijiet ta' fluss kontinwu.
English: A qualitative risk assessment based on a weight of evidence discussion was provided and this considered the likelihood of persistence, bioaccumulation and toxicity to occur under real environmental conditions.
Maltese: Ġiet ipprovduta valutazzjoni tar-riskju kwalitattiva bbażata fuq piż ta' diskussjoni tal-evidenza u din ikkunsidrat il-probabbiltà li jkun hemm persistenza, bijoakkumulazzjoni u tossiċità taħt kondizzjonijiet ambjentali reali.
English: The bioconcentration factors (BCFs) at the various time intervals were calculated by dividing the fish [3H]-residue concentration (parent equivalents in mg/kg), by the nominal concentration (parent equivalents in mg/l) of [3H]-residues in the test medium.
Maltese: Il-fatturi ta' bijokonċentrazzjoni (BCFs) fid-diversi intervalli tal-ħin ġew ikkalkulati billi l-konċentrazzjoni tar-residwu tal-ħut [3H] (ekwivalenti referenzjarji f'mg/kg), tiġi diviża bil-konċentrazzjoni nominali (ekwivalenti referenzjarji f'mg/kg) ta' residwi [3H] fil-medium tat-test.
English: The NOECs for emergence ratio, the most sensitive study endpoint, were 235 μg/kg dry weight based on nominal sediment concentrations and 111 µg moxidectin equivalents/kg dry weight, respectively.
Maltese: L-NOECs għall-proporzjoni tal-feġġa, l-aktar end-point sensittiv talistudju, kienu 235 μg/kg piż niexef abbażi ta' konċentrazzjonijiet tas-sediment nominali u 111 µg moxidectin ekwivalenti/kg piż niexef, rispettivament.
English: Additionally, a bioconcentration factor of 2244 l/kg was calculated using the following equation in a quantitative structure-activity relationship (QSAR) model: log BCFfish = 0.85 x logKow -0.70, based on an experimentally derived logKow of 4.766.
Maltese: Barra minn hekk, ġie kkalkulat fattur ta' bijokonċentrazzjoni ta' 2244 l/kg bl-użu tal-ekwazzjoni li ġejja f'mudell ta' relazzjoni struttura-attività kwantitattiva (QSAR): log BCFħut = 0.85 x logKow -0.70, abbażi ta' logKow ta' 4.766 derivat sperimentalment.
English: The following dissipation half-lives (DT50) at 20 °C were calculated using the best fit kinetic model i.e. simple first-order: 78.6, 139.0, 78.7 and 133.6 days for the soils sandy loam, sand, clay loam and loam, respectively.
Maltese: In-nofs ħajjiet ta' dissipazzjoni li ġejjin (DT50) f'20 C ġew ikkalkulati bl-użu tal-aħjar mudell kinetiku xieraq jiġifieri, lewwel ordni sempliċi: 78.6, 139.0, 78.7 u 133.6 jiem għall-ħamriji trab ġulġlieni ramli, ramel, trab ġulġlieni tafli u trab ġulġlieni, rispettivament.
English: A LC50 value of 0.62 µg/l was calculated based on measured concentrations.
Maltese: Ġie kkalkulat valur LC50 ta' 0.62 µg/l abbażi ta' konċentrazzjonijiet imkejla.
English: Risk mitigation measures for dung insects fulfilling the criteria of the CVMP reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal products (EMA/CVMP/ERAWP/409328/2010)16 could not be established.
Maltese: Ma setgħux jiġu stabbiliti miżuri ta' mitigazzjoni tar-riskji għal insetti tad-demel li jissodisfaw il-kriterji tad-dokument ta' riflessjoni tas-CVMP dwar miżuri ta' mitigazzjoni tar-riskji relatati mal-istima ta' riskju ambjentali ta' prodotti mediċinali veterinarji (EMA/CVMP/ERAWP/409328/2010)16.
English: CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 - EMA/CVMP/ERA/418282/2005-Rev.1- Corr. - link OECD guideline for the testing of chemicals no. 201: Freshwater Alga and Cyanobacteria, Growth Inhibition Test - link OECD guideline for the testing of chemicals no. 202: Daphnia sp.
Maltese: GL6 and GL38 - EMA/CVMP/ERA/418282/2005-Rev.1- Corr. - link 5 OECD guideline for the testing of chemicals no. 201:
English: D-54570 Densborn Germany
Maltese: D-54570
English: Consequently, given the limited number of different classes of end/ectoparasiticides, veterinary medicinal products containing moxidectin are an important therapeutic alternative to other veterinary medicinal products containing macrocyclic lactones.
Maltese: Konsegwentement, minħabba n-numru limitat ta' klassijiet differenti ta' end-/ektoparassitiċidi, prodotti mediċinali veterinarji li fihom moxidectin huma għażla alternattiva terapewtika importanti għal prodotti mediċinali veterinarji oħra li fihom lattoni makroċikliċi.
English: Non-extractable residues accounted for 4-10% of the radioactivity applied to the soil.
Maltese: Ir-residwi li ma jistgħux jiġu estratti ammontaw għal 4-10 % tar-radjuattività applikata għall-ħamrija.
English: PECsoil plateau (ng/kg)
Maltese: PECplateau tal-ħamrija (ng/kg)
English: The NOEC of moxidectin for reproduction in D. magna was therefore concluded to be >10 ng/l.
Maltese: Għalhekk, l-NOEC ta' moxidectin għar-riproduzzjoni f'D. magna ġiet konkluża li kienet >10 ng/l.
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 an important therapeutic alternative, 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;
Maltese: • is-CVMP ikkunsidra li prodotti mediċinali veterinarji li fihom moxidectin li għandhom jingħataw lil frat, ngħaġ u żwiemel bħala formulazzjonijiet li jitferrgħu, injetabbli u orali huma alternattiva terapewtika importanti, minħabba n-numru limitat ta' klassijiet differenti ta' end-/ektoparasittiċidi u l-prinċipju ta' użu responsabbli li jeħtieġ l-użu ta' sustanzi ta' klassijiet differenti ta' antiparasittiċi għall-kontroll ta' pasitożijiet sabiex jitnaqqas ir-riskju ta' żvilupp ta' reżistenza;
English: 15 OECD guideline for the testing of chemicals no. 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) - link authorisation holders concluded that exposure of surface water to moxidectin is unlikely or extremely low.
Maltese: 15 OECD guideline for the testing of chemicals no. 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) - link