FrancophonIA/ELRC3.0 huggingface dataset:
English: At weeks 52 and 104, the majority of subjects (>95%) had IOP values of within ± 5mmHg of the baseline value.
Maltese: F'ġimgħat 52 u 104, il-maġġoranza tal-individwi (>95%) kellhom valuri ta' IOP ta' ± 5mmHg mill-valur fil-linja bażi.
English: Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli bħalissa hija deskritta f'sezzjoni 5.1 u 5.2 iżda ma tista' tingħata l-ebda rakkomandazzjoni dwar il-pożoloġija.
English: There was no evidence for higher quantifiable levels of fluticasone furoate in younger children (less than 6 years of age).
Maltese: Ma kien hemm ebda evidenza ta' livelli kwantifikabbli ta' fluticasone furoate ogħla fi tfal iżgħar (ta' inqas minn 6 snin).
English: In a bioavailability study, intranasal doses of up to 2640 micrograms per day were administered over three days with no adverse systemic reactions observed (see section 5.2).
Maltese: Fi studju dwar bijodisponibilta`, ittieħdu dożi fl-imnieħer sa 2640 mikrogrammi kuljum għal tlett ijiem mingħajr ma ġew osservati ebda reazzjonijiet sistemiċi avversi (ara sezzjoni 5.2).
English: A 6-week study that assessed the effect of fluticasone furoate nasal spray 110 micrograms once daily on adrenal function in children aged 2 to 11 years showed that there was no significant effect on 24-hour serum cortisol profiles, compared with placebo.
Maltese: Studju ta' 6 ġimgħat li fih saret stima ta' l-effett ta' 110 mikrogrammi ta' sprej nażali fluticasone furoate darba kuljum fuq il-funzjoni adrenali fi tfal ta' bejn sentejn u 11-il sena wera li ma kien hemm ebda effett sinifikanti fuq il-profili ta' serum cortisol f'24 siegħa, meta mqabbel ma' plaċebo.
English: Caution is recommended when co-administering fluticasone furoate with potent CYP3A inhibitors including cobicistat-containing products as an increase in the risk of systemic side effects is expected.
Maltese: Fluticasone furoate għandu jintuża b'kawtela meta jittieħed flimkien ma' inibituri qawwija ta' CYP3A inkluż prodotti li fihom cobicistat għaliex hija mistennija żieda fir-riskju tal-effetti sekondarji sistemiċi.
English: The medicinal product is available in three pack sizes: 1 bottle of 30, 60 or 120 sprays.
Maltese: Il-prodott mediċinali jinsab f'pakketti ta' tliet daqsijiet: flixkun wieħed ta' 30, 60 jew 120 sprejjaturi.
English: Do not use Avamys:
Maltese: It-teħid ta' Avamys:
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/
English: Following intravenous administration, the elimination phase half-life averaged 15.1 hours.
Maltese: Wara l-użu mill-vina, il-fażi ta' eliminazzjoni half-life kienet b'medja ta' 15.1 sigħat.
English: The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Maltese: Id-doża għandha titnaqqas sa' l-inqas doża fejn jinżamm kontroll effettiv tas-sintomi.
English: The recommended starting dose is one spray actuation (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 55 micrograms).
Maltese: Id-doża rakkomandata hi ta' sprejjatura waħda (27.5 mikrogrammi ta' fluticasone furoate f'kull sprejjatura li tiġi attwata) f'kull minħar kuljum (doża totali ta' 55 mikrogrammi kuljum).
English: Less than 1 % of dose-related material is excreted in urine and therefore renal impairment would not be expected to affect the pharmacokinetics of fluticasone furoate.
Maltese: Inqas minn 1% ta' sustanzi relatati mad-dożi joħorġu ma' l-awrina u għalhekk indeboliment tal-kliewi mhuwiex mistenni li jaffettwa l-farmakokinetiċi ta' fluticasone furoate.
English: A randomised, double-blind, parallel-group, multicenter, one-year placebo-controlled clinical growth study evaluated the effect of fluticasone furoate nasal spray 110 micrograms daily on growth velocity in 474 prepubescent children (5 to 7.5 years of age for girls and 5 to 8.5 years of age for boys) with stadiometry.
Maltese: Studju ta' sena dwar it-tkabbir kliniku, randomised, double-blind, bi grupp parallel, multiċentriku u ikkontrollat bil-plaċebo evalwa l-effett ta' fluticasone furoate sprej għall-imnieħer 110 mikrogrammi kuljum fuq il-veloċità tat-tkabbir f'474 tifel/tifla ta' qabel il-pubertà (età ta' 5 sa 7.5 snin għall-bniet u 5 sa 8.5 snin għas-subien) permezz ta' stadjumetrija.
English: Each spray delivers 27.5 micrograms of fluticasone furoate
Maltese: Kull sprejjatura fiha 27.5 mikrogrammi ta' fluticasone furoate
English: In perennial allergic rhinitis, fluticasone furoate nasal spray 55 micrograms once daily exhibited a more consistent efficacy profile than fluticasone furoate nasal spray 110 micrograms once daily over 4 weeks' treatment.
Maltese: Fil-każ ta' rinite allerġika fuq tul ta' żmien, 55 mikrogrammi kuljum ta' sprej nażali fluticasone furoate irriżultaw fi profil ta' effikaċja aktar konsistenti minn 110 mikrogrammi darba kuljum ta' lisprej nażali fluticasone furoate fi trattament ta' erba' ġimgħat.
English: Children and adolescents Do not use in children under 6 years old.
Maltese: Tfal u adolexxenti Tużax fi tfal taħt l-età ta' 6 snin.
English: Pregnancy
Maltese: Żennuna
English: These events were transient in nature for six subjects in the fluticasone furoate group and one placebo subject.
Maltese: Dawn l-avvenimenti kienu ta' natura temporanja għal sitt individwi fil-grupp ta' fluticasone furoate u individwu wieħed fuq plaċebo.
English: In the majority of patients fluticasone furoate is not quantifiable (< 10 pg/ml) following intranasal dosing of 110 micrograms once daily.
Maltese: Fil-maġġoranza ta' pazjenti fluticasone furoate ma jistax jiġi kwantifikat (< 10 pg/mL) wara dożaġġ flimnieħer ta' 110 mikrogrammi darba kuljum.
English: Avamys 27.5 micrograms/spray nasal spray suspension Fluticasone furoate
Maltese: Avamys 27.5 mikrogrammi/ sprejjatura ta' suspensjoni li jintuża bħala sprej fl-imnieħer Fluticasone furoate
English: Avamys 27.5 micrograms per spray nasal spray suspension Fluticasone furoate
Maltese: Avamys 27.5 mikrogrammi/sprejjatura ta' suspensjoni li jintuża bħala sprej fl-imnieħer Fluticasone furoate
English: Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods (see section 4.4).
Maltese: Corticosteroids nażali jistgħu jkollhom effetti sistemiċi, speċjalment meta tingħata doża għolja għal perjodu twil (ara sezzjoni 4.4).
English: How to store Avamys
Maltese: X'fih Avamys
English: Mean growth velocity over the 52-week treatment period was lower in the patients receiving fluticasone furoate (5.19 cm/year) compared to placebo (5.46 cm/year).
Maltese: Il-veloċità medja tat-tkabbir matul il-perijodu ta' kura ta' 52 ġimgħa kienet aktar baxxa f'pazjenti li rċevew fluticasone furoate (5.19 cm/sena) meta mqabbla mal-plaċebo (5.46 cm/sena).
English: This is important as Avamys is a thick suspension that becomes liquid when you shake it well - see picture b. It will only spray when it becomes liquid.
Maltese: Dan huwa importanti peress li Avamys huwa suspensjoni magħquda li ssir likwida meta tħawwdu sew - ara stampa b. Ser jisprejja biss meta jsir likwidu.
English: • Avamys comes in an amber glass bottle.
Maltese: • Avamys jiġi fi flixkun tal-ħġieġ lewn l-ambra.
English: Fluticasone furoate nasal spray significantly improved the patients' perception of overall response to therapy, and the patients' disease-related quality of life (Rhinoconjunctivitis Quality of Life Questionnaire - RQLQ), in all 4 studies.
Maltese: L-isprej nażali fluticasone furoate għamel titjib sinifikanti f'dik li hi perċezzjoni tal-pazjenti tarrispons ġenerali għat-terapija, u f'dik li hi kwalita` ta' ħajja relattiva għall-marda (Kwistjonarju dwar Kwalita` tal-Ħajja b'Rinokonġuntivite -RQLQ), f'kull wieħed mill-erba' studji.
English: Based on data with another glucocorticoid (fluticasone propionate), that is metabolised by CYP3A4, coadministration with ritonavir is not recommended because of the risk of increased systemic exposure of fluticasone furoate.
Maltese: Fuq il-bażi ta' tagħrif ma' glucocorticoid ieħor (fluticasone propionate), li hu metabolizzat bi CYP3A4, mhuwiex rakkomandat li jingħata flimkien ma' ritonavir minħabba r-riskju ta' esponiment sistemiku akbar ta' fluticasone furoate.
English: Therefore, no clinical studies have been conducted to investigate interactions of fluticasone furoate on other drugs.
Maltese: Għaldaqstant, ebda studji kliniċi ma twettqu biex jiġu mistħarrġa interazzjonijiet ta' fluticasone furoate ma' mediċini oħra.
English: Seasonal and perennial allergic rhinitis in children:
Maltese: Segwi dawn il-passi:
English: There were over 2700 patients treated with fluticasone furoate in safety and efficacy studies for seasonal and perennial allergic rhinitis.
Maltese: Kien hemm aktar minn 2,700 pazjent ikkurati bi fluticasone furoate fi studji ta' sigurtà u effikaċja għal rinite allerġika tal-istaġun u rinite li ddum għal tul ta' żmien.
English: Growth retardation **In a one-year clinical study assessing growth in pre-pubescent children receiving 110 micrograms of fluticasone furoate once daily, an average treatment difference of -0.27 cm per year in growth velocity was observed compared to placebo (see Clinical efficacy and safety).
Maltese: Dewmien fl-iżvilupp mit-tul **Fi studju kliniku ta' sena li evalwa l-iżvilupp mit-tul fi tfal ta' qabel il-pubertà li kienu qed jirċievu 110 mikrogrammi ta' fluticasone furoate darba kuljum, kienet osservata differenza medja bil-kura ta' -0.27 ċm kull sena fil-veloċità tal-iżvilupp mit-tul meta mqabbel mal-plaċebo (ara Effikaċja klinika u sigurtà).
English: In animal studies glucocorticoids have been shown to induce malformations including cleft palate and intra-uterine growth retardation.
Maltese: F' studji fuq annimali ntwera li glucocorticoids jistgħu jwasslu għal deformazzjonijiet inklużi cleft palate u żvilupp ritardat ġewwa l-utru.
English: The absolute bioavailability for intranasal fluticasone furoate is 0.50 %, such that less than 1 microgram of fluticasone furoate would be systemically available after administration of 110 micrograms (see section 4.9).
Maltese: Il-bijodisponibilta` assoluta ta' fluticasone furoate fl-imnieħer hi ta' 0.50 % jiġifieri wara l-amministrazzjoni ta' 110 mikrogrammi ta' fluticasone furoate, anqas minn mikrogramm wieħed ikun jinsab fid-demm.
English: Onset of action has been observed as early as 8 hours after initial administration.
Maltese: Il-bidu tal-azzjoni kien osservat wara biss 8 sigħat mill-għoti inizjali.
English: AVAMYS 27.5 micrograms/spray, nasal spray suspension
Maltese: AVAMYS 27.5 mikrogrammi f'kull sprej, suspensjoni għal użu bħala sprej fl-imnieħer
English: For full therapeutic benefit regular, scheduled usage is recommended.
Maltese: Għall-benefiċċju terapewtiku sħiħ huwa rrakkomandat użu skedat.
English: The intranasal dosing of 110 micrograms once daily does not typically result in measurable plasma concentrations (<10 pg/ml).
Maltese: L-użu ta' dożi ta' 110 mikrogrammi fl-imnieħer darba kuljum ma jirriżultax tipikament f'konċentrazzjonijiet ta' plażma li jistgħu jitkejlu (< 10 pg/mL).
English: Fluticasone furoate nasal spray 110 micrograms once daily significantly improved nasal symptoms as well as patients' perception of overall response to therapy compared to placebo in three studies.
Maltese: 110 mikrogrammi kuljum ta' sprej nażali fluticasone furoate ġabu titjib sinifikanti tas-sintomi flgħajnejn kif ukoll f'dik li hi perċezzjoni tal-pazjenti tal-kwalita` ta' ħajja relattiva għall-marda
English: Patients not adequately responding to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) may use two spray actuations in each nostril once daily (total daily dose, 110 micrograms).
Maltese: Pazjenti li ma jkunux juru titjib adegwat bi sprejjatura waħda li tiġi attwata f'kull minħar darba kuljum (doża totali ta' 55 mikrogrammi kuljum) jistgħu jagħmlu żewġ sprejjaturi li jiġu attwati f'kull minħar darba kuljum (total ta' 110 mikrogrammi kuljum).
English: Hepatic Impairment No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Maltese: Indeboliment tal-kliewi M'hemmx bżonn ta' aġġustament ta' dożi f'din il-popolazzjoni (ara sezzjoni 5.2).
English: If there is any reason to believe that adrenal function is impaired, care must be taken when transferring patients from systemic steroid treatment to fluticasone furoate.
Maltese: Jekk ikun hemm xi raġuni biex wieħed jifhem li l-funzjoni tal-adrenali hija indebolita, għandu jkun hemm attenzjoni meta l-pazjenti jinqalbu minn kura bi sterojdi sistemiċi għal fluticasone furoate.
English: Growth retardation has been reported in children receiving nasal corticosteroids.
Maltese: Preparazzjonijiet nażali kortikosterojdi.
English: 14.2 ml Type I or Type III amber bottle (glass) fitted with a metering spray pump.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 14.2 ml flixkun lewn l-ambra (ħġieġ) ta' Tip I jew Tip III li għandu miegħu pompa li tirregola l-isprej.
English: Renal Impairment No dose adjustment is required in this population (see section 5.2).
Maltese: Pazjenti anzjani M'hemmx bżonn ta'aġġustament ta' dożi f'din il-popolazzjoni (ara sezzjoni 5.2).
English: Nasal septum perforation
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD
English: Store upright.
Maltese: ġurnata jew aktar.
English: Epistaxis *In paediatric clinical studies of up to 12 weeks duration the incidence of epistaxis was similar between patients receiving fluticasone furoate and patients receiving placebo.
Maltese: Epistassi * Fi studji pedjatriċi kliniċi b'tul sa 12-il ġimgħa l-inċidenza ta' epistassi kienet simili bejn pazjenti li kienu qed jirċievu fluticasone furoate u pazjenti li kienu qed jirċievu plaċebo.
English: Each spray delivers 27.5 micrograms of fluticasone furoate.
Maltese: Kull sprejjatura li tiġi attwata tagħti 27.5 mikrogrammi ta' fluticasone furoate
English: The safety and efficacy of Avamys in children under the age of 6 years has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Avamys fi tfal b'età inqas minn 6 snin ma ġewx determinati s'issa.
English: These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations.
Maltese: Dawn l-effetti huma ħafna inqas probabbli li jseħħu minn ma' kortikosterojdi orali u jistgħu jvarjaw f'pazjenti individwali u bejn preparazzjonijiet differenti ta' kortikosterojdi.
English: Symptoms include: - becoming very wheezy, coughing or having difficulty with breathing - suddenly feeling weak or light-headed (which may lead to collapse or loss of consciousness) - swelling around the face - skin rashes or redness.
Maltese: Sintomi jinkludu: - jaqbdek ħafna tħarħir, sogħla jew ikollok diffikultà biex tieħu n-nifs - tħossok debboli jew sturdut f'daqqa (li jista' jwassal għal kollass jew telf ta' koxxjenza) - nefħa madwar il-wiċċ - raxx jew ħmura fil-ġilda.
English: In some patients benzalkonium chloride can cause irritation in the inside of the nose.
Maltese: F'xi pazjenti benzalkonium chloride jista' jikkawża irritazzjoni ġewwa l-imnieħer.
English: Toxicol Chem 24: 423-430.
Maltese: Env. Toxicol Chem 24: 423-430.
English: 2.3.4 Microorganisms
Maltese: 2.3.4 Mikroorganiżmi
English: Enro-K 10% Oral Solution
Maltese: Enro-K 10% Soluzzjoni Orali Soluzzjoni Orali
English: The EC50 values for M. aeruginosa and P. subcapitata were 49 and 3,100 µg/l, respectively.
Maltese: Il-valuri EC50 għal M. aeruginosa u P. subcapitata kienu 49 u 3,100 µg/l, rispettivament.
English: 2.1.1 Metabolism and excretion
Maltese: 2.1.1 Metaboliżmu u eliminazzjoni
English: 2.3.1 Algae
Maltese: 2.3.1 Alki
English: The soil characteristics and resulting DT50 and DT90 values were: DT50: 141, 103, 99 and 149 days; DT90: 469, 342, 330 and 495 days.
Maltese: Il-karatteristiċi tal-ħamrija u l-valuri DT50 u DT90 li jirriżultaw kienu: DT50: 141, 103, 99 u 149 jum; DT90: 469, 342, 330 u 495 jum.
English: The difference in DT50 and DT90 values are relative small.
Maltese: Id-differenza fil-valuri DT50 u DT90 hija relattivament żgħira.
English: The seeds were placed in a natural sandy soil containing the test item at nominal concentrations of 10, 31.6, 100, 316 and 1000 mg enrofloxacin/kg dry soil (cucumber, lettuce, mung bean, oat and wheat) and 3, 12, 48, 192 and 768 mg enrofloxacin/kg dry soil (rye), respectively.
Maltese: Iż-żrieragħ tpoġġew f'ħamrija ramlija naturali li kien fiha l-oġġett tat-test f'konċentrazzjonijiet nominali ta' 10, 31.6, 100, 316 u 1000 mg enrofloxacin/kg ħamrija xotta (ħjar, ħass, fażola mung, ħafur u qamħ) u 3, 12, 48, 192 u 768 mg enrofloxacin/kg ħamrija xotta (segala), rispettivament.
English: The Koc was calculated as 110,885 l kg/1(geometric mean).
Maltese: Il-Koc ġie kkalkulat bħala 110,885 l kg/1 (medja ġeometrika).
English: Enro-K 10% Oral Solution contains 100 mg enrofloxacin as active ingredient per 1 ml product.
Maltese: Enro-K 10% Soluzzjoni Orali fih 100 mg enrofloxacin bħala sustanza attiva f'kull 1 ml tal-prodott.
English: Poland
Maltese: SPANJA
English: 2.2.1 PECsoil-plateau
Maltese: 2.2.1 PECħamrija-plateau
English: The following test species were used: Cucumis sativus (cucumber), Lactuca sativa (lettuce), Phaseolus aureus (mung bean), Avena sativa (oat), Triticum aestivum (wheat) and Secale cereale (rye).
Maltese: Intużaw l-ispeċi tat-test li ġejjin: Cucumis sativus (ħjar), Lactuca sativa (ħass), Phaseolus aureus (fażola mung), Avena sativa (ħafur), Triticum aestivum (qamħ) u Secale cereale (segala).
English: Env.
Maltese: Qawwa
English: Ciprofloxacin is the main metabolite of enrofloxacin.
Maltese: Ciprofloxacin huwa l-prodott metaboliku ewlieni ta' enrofloxacin.
English: A study taken from the open literature, Robinson et al. (2005)2, studied the toxicity of enrofloxacin to algae Microcystis aeruginosa (cyanobacteria or blue-green algae) and Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum, green alga).
Maltese: (2005)2, studja t-tossiċità ta' enrofloxacin fuq lalki Microcystis aeruginosa (cyanobacteria jew alka blu-ħadra) u Pseudokirchneriella subcapitata (li qabel kienet magħrufa bħala Selenastrum capricornutum, alka ħadra).
English: A study, taken from the open literature, Boxall et al (2006)3, was also provided.
Maltese: Kien ipprovdut ukoll studju meħud mil-letteratura miftuħa, Boxall et al (2006)3.
English: The effect of enrofloxacin on nitrogen transformation by soil organisms was investigated according to OECD guidelines 216 and EU Test Method C.21.
Maltese: L-effett ta' enrofloxacin fuq it-trasformazzjoni tan-nitroġenu minn organiżmi tal-ħamrija kien investigat skont linji gwida tal-OECD 216 u l-Metodu tat-Test UE C.21.
English: 2.2.3 PECsurfacewater (PECsw)
Maltese: 2.2.3 PECilma tal-wiċċ (PECsw)
English: A conservative PNEC value could hence be established at 10 µg/l.
Maltese: Għalhekk seta' jiġi stabbilit valur PNEC konservattiv ta' 10 µg/l.
English: 2.3.3 Fish Robinson et al. (2005)2 studied the toxicity of enrofloxacin to Pimephales promelas (fathead minnow).
Maltese: (2005)2 studjaw it-tossiċità ta' enrofloxacin għal Pimephales promelas (fathead minnow).
English: A terrestrial plant growth test according to OECD guideline 208 was provided.
Maltese: Kien ipprovdut test ta' żvilupp ta' pjanti terrestri skont il-linja gwida OECD 208.
English: 2.1.2 Soil adsorption and desorption A study, published in the peer-reviewed and open literature (Nowara et al 1997)1 indicated that enrofloxacin and other fluoroquinolones are strongly adsorbed to soils with high content in clay minerals of montmorillonite and kaolinite, basically through electrostatic interactions between ionized carboxylated groups of fluoroquinolones and exchangeable cations within clay layers.
Maltese: 2.1.2 Adsorbiment u disorbiment tal-ħamrija Studju, ippubblikat f'letteratura miftuħa u rreveduta minn pari (Nowara et al 1997)1 indika li enrofloxacin u fluoroquinolones oħrajn jiġu adsorbiti bil-qawwa minn ħamrija b'kontenut għoli ta' minerali tat-tafal ta' montmorillonite u kaolinite, bażikament permezz ta' interazzjonijiet elettrostatiċi bejn gruppi karbossilati jonizzati ta' fluoroquinolones u katjoni li jistgħu jiġu skambjati fi ħdan is-saffi tat-tafal.
English: Rye was the most sensitive species, with an EC50 of 124 mg/kg.
Maltese: Is-segala kienet l-iktar speċi sensittiva, b'EC50 ta' 124 mg/kg.
English: 4 Knapp CW, Cardoza LA, Hawes JN, Wellington EMH, Larive CK, Graham DW.
Maltese: Knapp CW, Cardoza LA, Hawes JN, Wellington EMH, Larive CK, Graham DW. Fate and Effects of Enrofloxacin in Aquatic Systems under Different Light Conditions.
English: Other data are taken from peer reviewed articles published in the open literature.
Maltese: Data oħra tittieħed minn artikli rreveduti minn pari ippubblikati filletteratura miftuħa.
English: Consequently no risk quotient (PEC/PNEC) is derived for cyanobacteria.
Maltese: Konsegwentement ma nħareġ l-ebda kwozjent tarriskju (PEC/PNEC) għal cyanobacteria.
English: 2.3.5 Plants
Maltese: 2.3.5 Pjanti
English: Application of the CVMP guideline Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH guidelines GL6 and GL38 results in an estimate of PECsurfacewater of 0.019 µg/l.
Maltese: L-applikazzjoni tal-linja gwida tas-CVMP fuq il-Valutazzjoni tal-Impatt Ambjentali għall-Prodotti Mediċinali Veterinarji f'appoġġ għal-linji gwida VICH GL6 u GL38 tirriżulta fi stima talPECilma tal-wiċċ ta' 0.019 µg/l.
English: The CVMP concludes that it is not feasible to estimate an exact PNEC value for cyanobacteria based on the study by Robinson et al 2005.
Maltese: Is-CVMP ikkonkluda li mhuwiex fattibbli li tivvaluta valur PNEC b'mod preċiż għal cyanobacteria ibbażat fuq l-istudju minn Robinson et al 2005.
English: The EC50 for nitrogen transformation was estimated to be above 29 mg/kg soil.
Maltese: L-EC50 għat-trasformazzjoni tannitroġenu kienet stmata li hija aktar minn 29 mg/kg ħamrija.
English: The application of an assessment factor of 100 leads to a PNEC value of 0.49 µg/l for algae.
Maltese: L-applikazzjoni ta' fattur ta' valutazzjoni ta' 100 twassal għal valur PNEC ta' 0.49 µg/l għall-alki.
English: Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinoline group of antibiotics.
Maltese: Enrofloxacin hija sustanza antimikrobika sintetika bi spettru wiesa', li tagħmel parti mill-grupp ta' antibijotiċi fluoroquinoline.
English: 2.3.2 Aquatic invertebrates (Daphnia magna) Robinson et al. (2005)2 studied the toxicity of enrofloxacin to Daphnia magna (waterflea).
Maltese: (2005)2 studjaw it-tossiċità ta' enrofloxacin għal Daphnia magna (bergħud tal-ilma).
English: For all species tested a clear concentration dependent effect occurred and EC50 and NOEC values were found in the range of 124 to 435 and less than 10 to 100 mg/kg, respectively.
Maltese: Għall-ispeċi kollha ttestjati seħħ effett ċar dipendenti fuq il-konċentrazzjoni u l-valuri EC50 u NOEC instabu fil-medda ta' 124 sa 435 u inqas minn 10 sa 100 mg/kg, rispettivament.
English: Invented name Pharmaceutical form
Maltese: Għamla farmaċewtika
English: Using the current guidelines the calculated PECsoil-plateau is 542.9 µg/kg.
Maltese: Bl-użu tal-linji gwida attwali l-PECħamrija-plateau ikkalkulat huwa 542.9 µg/kg.
English: The disappearance of non-labelled enrofloxacin was investigated according to OECD guideline 307 in four soils with different content of organic carbon and clay and pH values.
Maltese: L-għajbien ta' enrofloxacin mhux ittikkettat ġie investigat skont il-linja gwida 307 tal-OECD f'erba' ħamrijiet b'kontenut differenti ta' karbonju organiku u tafal u valuri ta' pH.
English: 2.4 Risk characterisation
Maltese: Karatterizzazzjoni tar-riskju