FrancophonIA/ELRC3.0 huggingface dataset:
English: The grounds for the referral were concerns expressed by the United Kingdom that the use of intravenous moxifloxacin in community acquired pneumonia and complicated skin and soft tissues infections should be limited to when the standard treatments for these infections are not appropriate, and concerns from France regarding the medicine's risk of causing problems with the heart rhythm (QT-interval prolongation).
Maltese: Ir-raġunijiet għar-referenza kienu tħassib imfissra mir-Renju Unit li l-użu ta' moxifloxacin għal ġolvini fi pnewmonja akkwistata fil-komunità u f'infezzjonijiet ikkumplikati tal-ġilda u tat-tessuti rotob għandu jkun limitat għal meta trattamenti standard għal dawn l-infezzjonijiet ma jkunux xierqa, u tħassib minn Franza dwar ir-riskju tal-mediċina li tikkawża problemi relatati mar-rittmu tal-qalb (titwil tal-intervall QT).
English: Bayer Vital GmbH submitted Avalox solution for infusion for mutual recognition on the basis of the initial authorisation granted by Germany on 30 April 2002.
Maltese: Bayer Vital GmbH issottomettiet Avalox soluzzjoni għal infużjoni għal rikonoxximent reċiproku fuq il-bażi tal-awtorizzazzjoni inizjali mogħtija mill-Ġermanja nhar it-30 ta' April 2002.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Avalox solution for infusion.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni tal-mediċina Avalox soluzzjoni għal infużjoni.
English: However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 10 October 2008.
Maltese: Madankollu, l-Istati Membri ma setgħux jaslu għal ftehim u l-aġenzija regolatorja tal-mediċini Ġermaniża rreferiet ilkwistjoni lis-CHMP għal arbitraġġ fl-10 ta' Ottubru 2008.
English: It is used to treat the following bacterial infections: - community-acquired pneumonia (an infection of the lungs that is caught outside of hospital); - complicated infections of the skin and the soft tissues below the skin.
Maltese: Tintuża biex tikkura l-infezzjonijiet batterjali li ġejjin: - pnewmonja akkwsitata mill-komunità (infezzjoni tal-pulmuni li tinqabad barra minn sptar); - infezzjonijiet ikkumplikati tal-ġilda u tat-tessuti rotob taħt il-ġilda.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Avalox solution for infusion outweigh its risks, and therefore the marketing authorisation for Avalox solution for infusion should be granted in all concerned Member States.
Maltese: Linformazzjoni emendata għall-professjonisti tal-kura tas-saħħa u għall-pazjenti hija disponibbli minn hawn.
English: Oral solution 100% w/w
Maltese: Soluzzjoni orali 100% w/w
English: Member State Applicant/Marketing Authorisation Holder
Maltese: Stat Membru Applikant/Detentur tal-Awtorizzazzjoni għat-Tqegħid fis
English: 2.2.2 Effects on algae (cyanobacteria)
Maltese: 2.2.2 Effetti fuq l-alka (ċjanobatterji)
English: Ireland1
Maltese: L-Irlanda1
English: Czech Republic Huvepharma NV Uitbreidingstraat 80
Maltese: Ir-Repubblika Ċeka Huvepharma NV Uitbreidingstraat 80
English: Strength
Maltese: Suq
English: A study performed to assess the acute toxicity of tylosin tartrate to rainbow trout (Oncorhynchus mykiss) was provided.
Maltese: Ġie pprovdut studju li sar biex jivvaluta t-tossiċità akuta ta' tylosin tartrate għat-trota qawsalla (Oncorhynchus mykiss).
English: The resulting PEC/PNEC ratios are 1.16 (pigs), 2.986 (broilers), 1.47 (turkeys) and 2.13 (calves), i.e. resulting in a risk quotient (RQ) above 1 indicating a potential risk.
Maltese: Il-proporzjonijiet ta' PEC/PNEC li jirriżultaw huma 1.16 (ħnieżer), 2.986 (brojlers), 1.47 (dundjani) u 2.13 (għoġiela), jiġifieri jirriżultaw fi kwozjent tar-riskju (RQ) ogħla minn 1 li jindika riskju potenzjali.
English: The PECssoil are: calves: 3199 µg/kg; pigs: 1738 μg/kg; broilers: 4435 μg/kg and turkeys 2210 μg/kg.
Maltese: 3199 µg/kg; ħnieżer: 1738 μg/kg; brojlers:
English: • In pigs: for treatment and prevention of porcine intestinal adenomatosis (ileitis) associated with Lawsonia intracellularis and for the treatment and prevention of enzootic pneumonia caused by Mycoplasma hyopneumoniae and Mycoplasma hyorhinis;
Maltese: • Fil-ħnieżer: għat-trattament u l-prevenzjoni ta' adenomatożi intestinali tal-ħnieżer (ileite) assoċjata ma' Lawsonia intracellularis u għat-trattament u l-prevenzjoni ta' pulmonite enzootika minn Mycoplasma hyopneumoniae u Mycoplasma hyorhinis;
English: 2.2.3 Effects on aquatic invertebrates
Maltese: 2.2.3. Effetti fuq invertebrati tal-ilma
English: The EC50 value for 48 hour survival of Daphnia magna exposed to tylosin tartrate was 680 mg/l.
Maltese: Il-valur ta' EC50 għas-sopravivenza ta' 48 siegħa ta' Daphnia magna esposta għal tilosina tartrat kien 680 mg/l.
English: 2.2 Risk to aquatic organisms
Maltese: 2.2 Riskju għal organiżmi tal-ilma
English: A study in turkey litter describes a rapid dissipation of tylosin under aerobic and sterile conditions with a half-live (DT50) of 4.9 days.
Maltese: Studju fil-ħmieġ tad-dundjani jiddeskrivi dissipazzjoni rapida tat-tilosina f'kundizzjonijiet aerobiċi u sterili b'half-life (DT50) ta' 4.9 ijiem.
English: However, using the maximum predicted surface water concentration for Pharmasin 100% W/W Water Soluble Granules (4.44 μg/l), the PEC/PNEC ratio was 1.1.
Maltese: Madankollu, bl-użu talkonċentrazzjoni massima mbassra tal-ilma tal-wiċċ għal Pharmasin 100% W/W Water Soluble Granules (4.44 μg/l), il-proporzjon tal-PEC/PNEC kien 1.1.
English: Effects on Daphnia magna were determined based on data from published literature.
Maltese: L-effetti fuq Daphnia magna ġew stabbiliti skont id-dejta minn letteratura ppubblikata.
English: • a risk for cyanobacteria cannot be excluded on the basis of the data available;
Maltese: • ma jistax jiġi eskluż riskju għaċ-ċjanobatterji abbażi tad-dejta disponibbli;
English: Based on the information presented it is not possible to tell if two of the criteria, seedling emergence of at least 70% and mean survival of emerged control seedlings of at least 90% for the duration of the study, were met.
Maltese: Skont l-informazzjoni ppreżentata, mhuwiex possibbli li jingħad jekk tnejn mill-kriterji, feġġa ta' nebbieta ta' mill-inqas 70% u medja ta' sopravivenza ta' nebbieta ta' kontroll li feġġet ta' mill-inqas 90% għat-tul tal-istudju, ġewx sodisfatti.
English: Risk mitigation measures
Maltese: Valutazzjoni tar-riskju ambjentali
English: The maximum predicted surface water concentration was 4.44 μg/l.
Maltese: Il-konċentrazzjoni massima prevista tal-ilma tal-wiċċ kienet 4.44 μg/l.
English: The experiments cover the effects of tylosin at concentrations between 0 and 5000 mg/kg soil (dry weight) on collembolans, earthworms and enchytraeids but did not use standardised methods.
Maltese: L-esperimenti jkopru l-effetti ta' tilosina f'konċentrazzjonijiet ta' bejn 0 u 5000 mg/kg ħamrija (piż xott) fuq collebolams, ħniex u enkitreidi iżda ma użawx metodi standardizzati.
English: 2.1 Risk to terrestrial compartment
Maltese: 2.1 Riskju għall-kumpartiment tal-art
English: Concentrations of tylosin in surface water and groundwater were estimated using methods described in the CVMP Revised Guideline on Environmental Impact Assessment for Veterinary Medicinal Products (EMEA/CVMP/ERA/418282/2005).
Maltese: Il-konċentrazzjonijiet ta' tilosina fl-ilma tal-wiċċ u fl-ilma tal-pjan kienu stmati bl-użu ta' metodi deskritti fil-Linja Gwida Riveduta tas-CVMP dwar il-Valutazzjoni tal-Impatt Ambjentali għall-Prodotti Mediċinali Veterinarji (EMEA/CVMP/ERA/418282/2005).
English: The study in five plant species, one monocotyledon (wheat) and four dicotyledons (courgette, French bean, radish and sunflower), was performed to assess the effects of tylosin tartrate, at concentrations of multiples of the maximum PEC for other Pharmasin products calculated at 7264.2 μg/kg, on seedling emergence and early growth of higher plants following exposure to the test substance in a sandy loam soil.
Maltese: L-istudju fuq ħames speċijiet ta' pjanti, waħda monokotelidone (qamħ) u erba' dikotiledoni (qara' bagħli [courgette], fażola, ravanell u ġirasol), sar biex jiġu ivvalutati l-effetti ta' tilosina tartrat, f'konċentrazzjonijiet ta' multipli tal-PEC massimu għal prodotti Pharmasin oħra kkalkulati f'7264.2 μg/kg, fit-tfellis tan-nebbieta u t-tkabbir kmieni ta' pjanti ogħla wara lespożizzjoni għas-sustanza tat-test f'ħamrija lom imrammla.
English: Huvepharma NV provided the statistical analysis for the proposed LOECs and NOECs for the three species (courgette, radish and sunflower).
Maltese: Huvepharma NV ppreżentat l-analiżi statistika għal-LOECs u għall-NOECs proposti għat-tliet speċijiet (qara' bagħli , ravanell u ġirasol).
English: There was very low nitrate production in the control soil between days 0 and 7, but this phenomenon was not observed at later time points.
Maltese: Kien hemm produzzjoni baxxa ħafna ta' nitrat fil-ħamrija tal-kontroll bejn il-jiem 0 u 7, iżda dan ilfenomenu ma ġiex osservat f'punti ta' ħin aktar tard.
English: 2.1.2 Effect on nitrate production by soil microorganisms
Maltese: 2.1.2 Effett fuq il-produzzjoni tan-nitrati mill-mikrorganiżmi tal-ħamrija
English: • In turkeys for the treatment and prevention of infectious sinusitis caused by Mycoplasma gallisepticum.
Maltese: • Fid-dundjani għat-trattament u l-prevenzjoni ta' sinużite infettiva kkawżata minn Mycoplasma gallisepticum.
English: Pharmasin 100% W/W Water Soluble Granules and its associated names is presented as water soluble granules containing tylosin tartrate, which is a macrolide antibiotic.
Maltese: Pharmasin 100% W/W Water Soluble Granules u l-ismijiet assoċjati tiegħu huwa ppreżentat bħala granuli li jinħallu fl-ilma li fihom tilosina tartrat (tylosin tartrate), antibijotiku makrolide.
English: The lowest EC50 determined in the study was for radish, and was 149.9 mg/kg, and the lowest NOEC and LOEC values were determined for courgette at 45.4 mg/kg and 90.8 mg/kg, respectively.
Maltese: L-aktar EC50 baxxa determinata fl-istudju kienet għar-ravanell, u kienet 149.9 mg/kg, u l-aktar valuri NOEC u LOEC baxxi ġew stabbiliti għall-qara' bagħli f'45.4 mg/kg u 90.8 mg/kg rispettivament.
English: PECsurfacewater values for the same species were calculated as 2.14, 5.47, 2.72 and 3.93 µg/l respectively.
Maltese: Ilvaluri tal-PECilma tal-wiċċ għall-istess speċijiet ġew ikkalkulati bħala 2.14, 5.47, 2.72 u 3.93 µg/l rispettivament.
English: Using this approach Huvepharma NV concluded that the maximum predicted surface water concentration could be revised from 4.44 μg/l to 1.77 μg/l, leading to a TWA PEC/PNEC ratio of 0.42, indicating according to the applicant that Pharmasin 100% W/W Water Soluble Granules does not pose a risk for blue-green algae (cyanobacteria).
Maltese: Bl-użu ta' dan l-approċċ, Huvepharma NV kkonkludiet li l-konċentrazzjoni massima prevista ta' ilma tal-wiċċ tista' tkun riveduta minn 4.44 μg/l għal 1.77 μg/l, li twassal għal proporzjon ta' TWA PEC/PNEC ta' 0.42, li skont l-applikant jindika li Pharmasin 100% W/W Water Soluble Granules ma jippreżentax riskju għall-alka blu-ħadra (ċjanobatterji).
English: The 96 hour LC50 based on nominal test concentration was greater than 100 mg/l and correspondingly the NOEC was 100 mg/l.
Maltese: Ilvaluta ta' LC50 f'96 siegħa, abbażi ta' konċentrazzjoni tat-test nominali, kien ogħla minn 100 mg/l u b'mod korrispondenti, l-NOEC kien 100 mg/l.
English: • In calves: for the treatment and prevention of pneumonia caused by Mycoplasma spp;
Maltese: • Fl-għoġiela: għat-trattament u l-prevenzjoni ta' pulmonite ikkawżata minn Mycoplasma spp;
English: However, the PEC/PNEC ratio derived using the PEC for broilers (5.47 µg/l) was 1.30, indicating a risk of toxicity for cyanobacteria (blue-green algae).
Maltese: Madankollu, ilproporzjon tal-PEC/PNEC miksub bl-użu tal-PEC għall-brojlers (5.47 µg/l) kien ta' 1.30, li jindika riskju ta' tossiċità għaċ-ċjanobatterji (alka blu-ħadra).
English: 2.1.4 Summary of risk assessment to the terrestrial compartment
Maltese: 2.1.4 Sommarju tal-valutazzjoni tar-riskju għall-kumpartiment tal-art
English: PECgroundwater values for pigs, broilers, turkeys and calves were calculated as 6.43, 16.4, 8.17 and 11.8 µg/l respectively.
Maltese: Il-valuri tal-PECilma tal-pjan għall-ħnieżer, brojlers, dundjani u għoġiela kienu kkalkulati bħala 6.43, 16.4, 8.17 u 11.8 µg/l rispettivament.
English: A previously reported endpoint for Microcystis aeruginosa was not used in the assessment as it was not in line with the relevant OECD guideline 201.
Maltese: Endpoint irrappurtat qabel għal Microsystis aeruginosa ma ntużax fil-valutazzjoni billi dan ma kienx konformi mal-linja gwida 201 rilevanti tal-OECD.
English: • restricting the SPC by removing either indications alone or target species and indications is currently inappropriate as a conclusive assessment of the risk to the terrestrial and aquatic compartments cannot be carried out; Therefore, the CVMP is of the opinion that the application for Pharmasin 100% W/W Water Soluble Granules and associated names does not satisfy the criteria for authorisation in respect of environmental risk as established in Article 12(3)(j) of Directive 2001/82/EC, as amended by Directive 2004/28/EC.
Maltese: Għalhekk, is-CVMP huwa tal-opinjoni li l-applikazzjoni għal Pharmasin 100% W/W Water Soluble Granules u l-ismijiet assoċjati ma tissodisfax il-kriterji għal awtorizzazzjoni fir-rigward tar-riskju ambjentali kif stabbilit fl-Artikolu 12(3)(j) tad-Direttiva 2001/82/KE, kif emendata mid-Direttiva 2004/28/KE.
English: The DT50 value of 7.6 days for chicken excreta can be accepted as a realistic conservative value.
Maltese: Il-valur tad-DT50 ta' 7.6 ijiem għall-ħmieġ tat-tiġieġ jista' jkun aċċettat bħala valur prudenti u realistiku.
English: This would have the effect of reducing the TWA PEC from 1.77 μg/l to 0.40 μg/l, and lead to a PEC/PNEC ratio of 0.10.
Maltese: Dan ikollu l-effett li jnaqqas il-valur ta' TWA PEC minn 1.77 μg/l għal 0.40 μg/l, u jwassal għal proporzjon ta' PEC/PNEC ta' 0.10.
English: The study was performed with concentrations of tylosin in soil of 7264 μg/kg, which was derived from the maximum PEC of tylosin in soil arising from the use of other Pharmasin products, and at 5 times, 10 times, 25 times and 125 times this maximum PEC value.
Maltese: Ir-rappurtaġġ u l-analiżi tar-riżultat ma segwewx il-linja gwida tal-OECD. Listudju sar b'konċentrazzjonijiet ta' tilosina fil-ħamrija ta' 7264 μg/kg, li nkiseb mill-massimu ta' PEC ta' tilosina fil-ħamrija li rriżulta mill-użu ta' prodotti oħra ta' Pharmasin, u f'5 darbiet, 10 darbiet, 25 darba u 125 darba dan il-valur massimu ta' PEC.
English: Due to the unreliability of the data provided on the effects of tylosin on soil nitrification no conclusion can be drawn on the effects of Pharmasin 100% W/W Water Soluble Granules on soil microorganisms.
Maltese: Minħabba n-nuqqas ta' affidabilità tad-dejta pprovduta dwar l-effetti tat-tilosina fuq innitrifikazzjoni tal-ħamrija ma tista' tinsilet l-ebda konklużjoni fuq l-effetti ta' Pharmasin 100% W/W Water Soluble Granules fuq il-mikrorganiżmi tal-ħamrija.
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Maltese: TAL-PRODOTT MEDIĊINALI, SPEĊI TA' ANNIMALI, MNEJN JINGĦATA, APPLIKANT/DETENTUR TALAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: Therefore, a PNEC of 1.499 mg/kg was established, based on the lowest EC50 of 149.9 mg/kg applying an AF of 100.
Maltese: Għalhekk, ġie stabbilit PNEC ta' 1.499 mg/kg, ibbażat fuq l-aktar EC50 baxx ta' 149.9 mg/kg li japplika AF ta' 100.
English: Based on this EC50 value a PNEC of 4.2 μg/l was calculated (PNEC equal to EC50/100); the assessment factor of 100 is in line with the VICH GL38 guideline.
Maltese: Skont dan il-valur ta' EC50, ġie kkalkulat PNEC ta' 4.2 μg/l (PNEC ugwali għal EC50/100); il-fattur ta' valutazzjoni 100 huwa konformi mal-linja gwida VICH GL38.
English: The DT50 in manure reported in literature and the dissipation study were largely similar.
Maltese: Il-valuri tad-DT50 fid-demel irrapportati fil-letteratura u l-istudju tad-dissipazzjoni kienu fil-parti l-kbira tagħhom simili.
English: The product is a generic of the reference product Tylan W.O and intended to be used as follows:
Maltese: Il-prodott huwa ġeneriku tal-prodott ta' referenza Tylan W.O u huwa intenzjonat biex jintuża kif ġej:
English: Only for courgette was one concentration below this PEC (0.25 PEC).
Maltese: Għall-qara' bagħli biss kien hemm konċentrazzjoni waħda taħt dan il-PEC (PEC 0.25).
English: 2.2.4 Effects on fish
Maltese: 2.2.4 Effetti fuq il-ħut
English: The EC50 from this study was concluded to be greater than 100 mg/l and PNEC (EC50/1000) was concluded to be greater than 100 μg/l; the assessment factor of 1000 is in line with the VICH GL38 guideline.
Maltese: Minn dan l-istudju ġie konkluż li l-EC50 huwa ogħla minn 100 mg/l u l-PNEC (EC50/1000) ġie konkluż li huwa ogħla minn 100 μg/l; il-fattur ta' valutazzjoni ta' 1000 huwa konformi mal-linja gwida VICH GL38.
English: The assessment of the effects of Pharmasin 100% W/W Water Soluble Granules on soil invertebrates was based on a published study.
Maltese: Il-valutazzjoni tal-effetti ta' Pharmasin 100% W/W Water Soluble Granules fuq invertebrati talħamrija kienet ibbażata fuq studju ppubblikat.
English: Huvepharma NV provided an environmental risk assessment for Pharmasin 100% W/W Water Soluble Granules that followed in general the established guidelines and recommendations.
Maltese: Huvepharma NV pprovdiet valutazzjoni tar-riskju ambjentali għal Pharmasin 100% W/W Water Soluble Granules li b'mod ġenerali segwiet il-linji gwida u r-rakkomandazzjonijiet stabbiliti.
English: A new study and several published studies were provided which investigate the degradation of tylosin in cattle, pigs and poultry manure and soil/poultry mixtures.
Maltese: Ġie ppreżentat studju ġdid u diversi studji ppubblikati li jinvestigaw id-degradazzjoni ta' tilosina fid-demel tal-baqar, ħnieżer u tjur u f'taħlitiet ta' ħamrija u ħmieġ tat-tjur.
English: During the decentralised procedure concerns were raised that Pharmasin 100% W/W Water Soluble Granules may present a potential serious risk to public health regarding risk to algae and to terrestrial plants.
Maltese: Waqt il-proċedura deċentralizzata, tqajjem tħassib li Pharmasin 100% W/W Water Soluble Granules jista' jippreżenta riskju gravi potenzjali għas-saħħa pubblika fir-rigward tar-riskju għall-alka u lpjanti tal-art.
English: (EC50/1000) was therefore concluded to be 680 μg/l; the assessment factor of 1000 is in line with the VICH GL38 guideline.
Maltese: Għalhekk ġie konkluż li l-PNEC (EC50/1000) huwa 680 μg/l; il-fattur ta' valutazzjoni ta' 1000 huwa konformi mal-linja gwida VICH GL38.
English: The PNEC
Maltese: Qawwa
English: Based on the lowest reported EC10 of 149 mg/kg (dry weight) and applying an assessment factor (AF) of 10 a PNEC of 14.9 mg/kg for soil invertebrates can be derived.
Maltese: Abbażi fuq il-valur l-aktar baxx ta' EC10 rapportat ta' 149 mg/kg (piż xott) u bl-applikazzjoni ta' fattur ta' valutazzjoni (AF) ta' 10 jista' jinkiseb PNEC ta' 14.9 mg/kg għall-invertebrati tal-ħamrija.
English: EC50 values based on the geometric mean of test concentration were 1.5 mg/l for inhibition of growth rate and 0.42 mg/l for inhibition of yield.
Maltese: Il-valuri ta' EC50 ibbażati fuq il-medja ġeometrika tal-konċentrazzjoni tat-test kienu 1.5 mg/1 għall-inibizzjoni tar-rata ta' tkabbir u 0.
English: (CRD) caused by Mycoplasma gallisepticum and Mycoplasma synoviae and for the treatment and prevention of necrotic enteritis caused by Clostridium perfringens;
Maltese: • Fit-tiġieġ (brojlers, għewietaq): għat-trattament u l-prevenzjoni ta' mard respiratorju kroniku (CRD) ikkawżat minn Mycoplasma gallisepticum u Mycoplasma synoviae u għat-trattament u lprevenzjoni ta' enterite nekrotika kkawżata minn Clostridium perfringens;
English: Other degradation studies in manure suggest a significant role for biodegradation, resulting in differences between sterile and non-sterile conditions, which are not observed in this particular study.
Maltese: Studji oħrajn ta' degradazzjoni fid-demel jissuġġerixxu rwol sinifikanti għall-bijodegradazzjoni, li tirriżulta f'differenzi bejn il-kundizzjonijiet sterili u dawk li mhumiex, li mhumiex osservati f'dan l-istudju partikolari.
English: 2.1.1 Effects on soil invertebrates
Maltese: 2.1.1 Effetti fuq invertebrati tal-ħamrija
English: Partial chlorosis, extensive chlorosis and extensive chlorosis with leaf wilt was seen with all plant species in at least one test concentration, however information on phytotoxicity was not presented for the controls, so it was concluded that this criterion was not met. As the results of the control seedlings were not reported it is not possible to conclude if the mean survival of emerged control seedlings is at least 90% for the duration of the study as required by the OECD guidance.
Maltese: Fir-rapport, barra ttemperatura, m'hemm provdut l-ebda dejta dettaljata tal-kundizzjonijiet ġewwa s-serra, għalhekk huwa impossibbli li tinsilet konklużjoni dwar jekk il-kundizzjonijiet ambjentali kinux identiċi.
English: The difference in nitrate production between control and the lowest (1X) PEC at 28 days is 23% which is only just below the 25% maximum allowed by the OECD guideline.
Maltese: Id-differenza fil-produzzjoni ta' nitrat bejn il-PEC ta' kontroll u l-PEC l-aktar baxx (1X) fil-jum 28 hija 23% li hija kemxejn inqas mill-massimu ta' 25% permess mil-linja gwida tal-OECD. Meta wieħed iqis il-problemi kollha bl-istudju rreġistrati hawn fuq, il-fatt li l-valur joqrob lejn iddifferenza massima permessa jagħti lok għal tħassib.
English: The absence of reliable effects data for plants and microorganisms means that reducing exposure, i.e. lowering the PECsoil by restricting indications and species does not alter the potential for an unacceptable risk.
Maltese: In-nuqqas ta' dejta affidabbli dwar l-effetti fuq pjanti u mikrorganiżmi jfisser li t-tnaqqis tal-espożizzjoni, jiġifieri li jitbaxxa l-PECħamrija billi jiġu limitati l-indikazzjonijiet u l-ispeċijiet, ma jibdilx il-potenzjal ta' riskju mhux aċċettabbli.
English: However, the CVMP considered that there are concerns regarding the refinements made to the PECs generated using FOCUS modelling; in particular on the use of the time weighted averages in relation to the acute cyanobacteria study and the use of a DT50 value of 19.15 days in the FOCUS models when the geometric mean DT50 presented by Huvepharma NV was 51 days.
Maltese: Madankollu, is-CVMP kkunsidra li hemm tħassib rigward l-irfinar li sar għall-PECs bl-użu tal-mudelli FOCUS, b'mod partikolari fuq l-użu tal-medji mwieżna skont il-ħin fir-rigward tal-istudju taċċjanobatterji akut u l-użu ta' valur ta' DT50 ta' 19.15-il jum fil-mudelli FOCUS meta l-medja ġeometrica ta' DT50 ippreżentata minn Huvepharma NV kienet 51 jum.
English: The seedlings should not exhibit visible phytotoxic effects (e.g. chlorosis, necrosis, wilting, leaf and stem deformations) and the plants should exhibit only normal variation in growth and morphology for that particular species.
Maltese: In-nebbieta m'għandhomx juru effetti fitotossiċi viżibbli (eż. klorożi, nekrożi, dbiel, deformazzjonijiet fil-weraq u z-zokk) u l-pjanti għandhom jeżebixxu biss varjazzjonijiet normali fit-tkabbir u l-morfoloġija għal dik l-ispeċi partikolari.