FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common At the injection site: erythema, pain, swelling Common Pyrexia At the injection site: hematoma, pruritus Not known Asthenia*, chills*, fatigue*, malaise*
Maltese: • Żewġ labriet ta' tulijiet differenti huma pprovduti fil-pakkett, agħżel il-labra addattata sabiex tiżgura għoti ġol-muskolu (IM - intramuscular) skont id-daqs u l-piż tal-pazjent tiegħek.
English: At Month 7, in the Per Protocol population, the immune response in girls aged 9-13 years (n = 241) who received 2 doses of Gardasil (at 0, 6 months) was non-inferior and numerically higher to the immune response in women aged 16-26 years (n = 246) who received 3 doses of Gardasil (at 0, 2, 6 months).
Maltese: Fix-Xahar 7, fil-popolazzjoni Skont il-Protokoll, ir-rispons immuni fi bniet b'età minn 9 snin sa 13-il sena (n=241) li rċivew 2 dożi ta' Gardasil (fix-xhur 0 u 6) ma kienx inferjuri u kien numerikament ogħla mir-rispons immuni f'nisa b'eta minn 16 sa 26 sena (n=246) li rċivew 3 dożi ta' Gardasil (fix-xhur 0, 2 u 6).
English: Cami Pedra Estela s/n Reus (Tarragona) Spain
Maltese: Cami Pedra Estela s/n Reus (Tarragona)
English: Reus-Vinyols, KM.4,1 Riudoms (Tarragona) Spain
Maltese: Reus-Vinyols, KM.4,1 Riudoms (Tarragona)
English: Qualitative and quantitative composition
Maltese: Kompożizzjoni kwalitattiva u kwantitattiva
English: The reasoning being that:
Maltese: Irraġunament huwa li:
English: Šmarješka cesta 6
Maltese: KRKA d.d. Šmarješka cesta 6
English: Meat and offal: 107 days.
Maltese: Laħam u ġewwieni tal-annimal: 107 ijiem.
English: A 41-day withdrawal period was determined, following statistical evaluation of the residues depletion data using the WT1.4 software.
Maltese: Ġie stabbilit perjodu ta' rtirar ta' 41-jum, wara evalwazzjoni statistika tad-data ta' tnaqqis tar-residwi bl-użu tas-softwer WT1.4.
English: When administered parenterally, closantel is absorbed relatively quickly into the systemic circulation (Tmax = 8 - 24 h) and is highly bound to albumin in the plasma.
Maltese: Meta mogħti b'mod parenterali, closantel jiġi assorbit relattivament malajr fiċ-ċirkolazzjoni sistemika (Tmax = 8 - 24h) u jintrabat ħafna mal-albumina fil-plażma.
English: 1 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link less sensitive, at 500 µg/kg.
Maltese: 1 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link
English: 2 VICH topic GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker-residue-depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009) https://www.ema.europa.eu/documents/scientific-guideline/vich-gl48-studies-evaluate-metabolism-residue-kineticsveterinary-drugs-food-producing-animals_en.pdf
Maltese: Marker-residue-depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009) https://www.ema.europa.eu/documents/scientific-guideline/vich-gl48-studies-evaluate-metabolism-residue-kineticsveterinary-drugs-food-producing-animals_en.pdf tessuti li jittieklu sal-aħħar ta' perjodu tal-irtirar, u b'hekk joħloq riskju għall-konsumaturi tal-laħam u l-ġewwieni tan-nagħaġ ikkurati b'dawn il-prodotti.
English: In the GLP study, the injection sites were sampled on days 2, 7, 14, 24 and 29 days after treatment and analysed using an HPLC-FD method of analysis, validated in line with current requirements.
Maltese: Fl-istudju GLP, is-siti tal-injezzjoni ġew ikkampjunati fil-jiem 2, 7, 14, 24 u 29 jum wara l-kura u ġew analizzati bl-użu ta' metodu ta' analiżi HPLC-FD, ivvalidat skont ir-rekwiżiti attwali.
English: An application was submitted under Article 13(1) of Directive 2001/82/EC, i.e., a generic application for a marketing authorisation under the decentralised procedure for the veterinary medicinal product Santiola, containing 50 mg closantel per ml, with Ireland as Reference Member State (IE/V/0377/001/DC).
Maltese: Tressqet applikazzjoni skont l-Artikolu 13(1) tad-Direttiva 2001/82/KE, jiġifieri, applikazzjoni ġenerika għal awtorizzazzjoni għat-tqegħid fis-suq skont il-proċedura deċentralizzata għall-prodott mediċinali veterinarju Santiola, li fih 50 mg closantel għal kull ml, bl-Irlanda bħala Membru Stat ta' Referenza (IE/V/0377/001/DC).
English: All edible tissues, including injection sites, were sampled on days 19, 40, 61, 89, and 103 after treatment and analysed using an SPE-LC-MS/MS method of analysis, validated in line with current requirements.
Maltese: It-tessuti li jittieklu kollha, inkluż is-siti tal-injezzjoni, ġew ikkampjunati fil-jiem 19, 40, 61, 89 u 103 wara l-kura u ġew analizzati bl-użu ta' metodu ta' analiżi SPE-LC-MS/MS, ivvalidat skont ir-rekwiżiti kurrenti.
English: Closantel is a salicylanilide anthelmintic, a synthetic antiparasitic agent with efficacy against liver fluke, haematophagous nematodes and larval stages of some arthropods in sheep and cattle.
Maltese: Closantel huwa salicylanilide anthelmintic, aġent sintetiku antiparassitiku b'effikaċja kontra parassita (fluke) tal-fwied, nematodi ematofaġiċi u stadji ta' larva ta' xi artropodi fin-nagħaġ u l-ifrat.
English: Both studies administered a dose of 5 mg/kg body weight; however, due to differences in the weights of the animals used in the two studies, the volume of product administered was different (6.7 - 8.4 ml administered in Study 1; 3.6 - 5.8 ml administered in Study 2).
Maltese: Iż-żewġ studji amministraw doża ta' 5 mg/kg ta' piż tal-ġisem; madankollu, minħabba d-differenzi fil-piż talannimali użati fiż-żewġ studji, il-volum tal-prodott mogħti kien differenti (6.7- 8.4 ml mogħti fi Studju 1; 3.6- 5.8 ml mogħti fi Studju 2).
English: The limit of detection for muscle was also lower in Study 1 (<2 µg/kg) than in Study 2 (492 µg/kg).
Maltese: Il-limitu ta' skoperta għall-muskolu kien ukoll iktar baxx fl-Istudju 1 (<2 µg/kg) milli fi Studju 2 (492 µg/kg).
English: Information was received regarding the composition of the affected products (n = 5).
Maltese: Waslet informazzjoni dwar il-kompożizzjoni tal-prodotti affettwati (n = 5).
English: Czech Republic KRKA d.d.
Maltese: Ir-Repubblika Ċeka
English: In terms of sensitivity, the limit of quantification in Study 1 was determined as 150 µg/kg in muscle, whereas the limit of quantification in Study 2 was
Maltese: F'termini ta' sensittività, il-limitu ta' kwantifikazzjoni fl-Istudju 1 ġie ddeterminat bħala 150 µg/kg fil-muskolu, filwaqt li l-limitu ta' kwantifikazzjoni fi Studju
English: Quality, target animal safety, user safety, environmental risk and parasitic resistance for the concerned veterinary medicinal products have not been assessed in this referral procedure.
Maltese: Il-kwalità, is-sigurtà tal-annimal fil-mira, is-sigurtà tal-utent, ir-riskju ambjentali u r-reżistenza għallparassiti għall-prodotti mediċinali veterinarji kkonċernati ma ġewx ivvalutati f'din il-proċedura ta' referenza.
English: The main non-aqueous vehicle, propylene glycol, is present in both products in different quantities.
Maltese: Il-vettur ewlieni mhux akweu, propylene glycol, huwa preżenti fiż-żewġ prodotti fi kwantitajiet differenti.
English: One of these products (‘Flukiver 5%') was used in the pivotal residues study, Study 1.
Maltese: Wieħed minn dawn il-prodotti (“Flukiver 5%”) intuża fl-istudju pivotali tar-residwi, Studju 1.
English: The concentrations of closantel residues were below the respective maximum residue limits (MRLs) at 19 days after administration in kidney, 40 days in muscle and fat, and 89 days in liver.
Maltese: Il-konċentrazzjonijiet ta' residwi ta' closantel kienu taħt il-limiti massimi rispettivi ta' residwi (MRLs) fid-19-il jum wara l-għoti fil-kliewi, 40 jum fil-muskoli u x-xaħam, u 89 jum fil-fwied.
English: The residue depletion data for the marker tissue, liver, do not allow for a statistical determination of a withdrawal period (the assumption of normal distribution of the errors was not met).
Maltese: Id-data dwar it-tnaqqis tar-residwi għall-markatur tat-tessut, il-fwied, ma tippermettix li ssir determinazzjoni statistika ta' perjodu ta' rtirar (is-suppożizzjoni ta' distribuzzjoni normali tal-iżbalji ma ntlaħqitx).
English: Another (nationally-authorised) version of Flukiver Solution for Injection has been authorised in France since 1981; the marketing authorisation for this product was varied in 2016 and the withdrawal periods for sheep (meat and offal) were increased from 77 days to 107 days as a result of data provided during the variation procedure.
Maltese: Verżjoni oħra (awtorizzata nazzjonalment) ta' Flukiver Soluzzjoni għall-Injezzjoni ilha awtorizzata fi Franza mill-1981; l-awtorizzazzjoni għat-tqegħid fis-suq għal dan il-prodott kienet varjata fl-2016 u lperjodi ta' rtirar għan-nagħaġ (laħam u ġewwieni) żdiedu minn 77 jum għal 107 ijiem bħala riżultat ta' data pprovduta matul il-proċedura ta' varjazzjoni.
English: A GLP-compliant residue depletion study in sheep was submitted, conducted with the veterinary medicinal product ‘Flukiver 5%', a product containing 50 mg closantel per ml.
Maltese: Ġie ppreżentat studju dwar it-tnaqqis tar-residwi konformi mal-GLP fin-nagħaġ, li sar bil-prodott mediċinali veterinarju “Flukiver 5%”, prodott li fih 50 mg ta' closantel kull ml.
English: • the data from Study 1 show that the liver is the withdrawal period determining tissue, and that the ‘alternative method', as recommended in CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95), should be used to determine the withdrawal period as the statistical assumptions are not all met when trying to use the preferred statistical analysis.
Maltese: • id-data mill-Istudju 1 turi li l-fwied huwa t-tessut li jiddetermina l-perjodu ta' rtirar, u li l-"metodu alternattiv", kif irrakkomandat fin-nota CVMP għal gwida dwar l-approċċ lejn l-armonizzazzjoni talperjodi ta' rtirar (EMEA/CVMP/036/95), għandu jintuża biex jiddetermina l-perjodu tal-irtirar billi ssuppożizzjonijiet statistiċi mhumiex kollha ssodisfati meta jippruvaw jużaw l-analiżi statistika ppreferuta.
English: A GLP-compliant residue depletion study in sheep was submitted, conducted with the veterinary medicinal product ‘Endoex Solucion Injectable', a product containing 50 mg closantel per ml.
Maltese: Ġie ppreżentat studju dwar it-tnaqqis tar-residwi konformi mal-GLP fin-nagħaġ, li sar bil-prodott mediċinali veterinarju “Endoex Solucion Injectable”, prodott li fih 50 mg ta' closantel kull ml.
English: The product used in Study 2 ‘Endoex Solucion Injectable', has a level of propylene glycol that is not comparable to the product used in Study 1.
Maltese: Il-prodott użat fl-Istudju 2 “Endoex Solucion Injectable”, għandu livell ta' propylene glycol li mhuwiex komparabbli mal-prodott użat fl-Istudju 1.
English: The proposed sheep meat withdrawal period for the generic product, Santiola, was 77 days, in line with the Irish reference product (although the target species ‘sheep' was removed from the reference product during the application procedure for Santiola), but not in accordance with the data provided by France during the procedure.
Maltese: Il-perjodu propost għall-irtirar tal-laħam tan-nagħaġ għall-prodott ġeneriku, Santiola, kien ta' 77 jum, f'konformità mal-prodott ta' referenza Irlandiż (għalkemm l-ispeċi fil-mira 'nagħaġ' tneħħiet millprodott ta' referenza matul il-proċedura ta' applikazzjoni għal Santiola), iżda mhux skont id-data pprovduta minn Franza matul il-proċedura.
English: Finally, consideration has been given to the analytical methods that were used.
Maltese: Finalment, ingħatat konsiderazzjoni għall-metodi analitiċi li ntużaw.
English: Data were provided, based on the pharmacokinetics of closantel, that demonstrated that the formulation differences, and thereby the potential differences in the rates of absorption from the injection site, would not affect the overall elimination from the edible tissues, other than from the injection site itself.
Maltese: Ġiet ipprovduta data, ibbażata fuq il-farmakokinetiċi ta' closantel, li wriet li d-differenzi filformulazzjoni, u b'hekk id-differenzi potenzjali fir-rati ta' assorbiment mis-sit tal-injezzjoni, ma jaffettwawx l-eliminazzjoni totali mit-tessuti li jittieklu, għajr mis-sit tal-injezzjoni innifsu.
English: It has been noted that there are different approved withdrawal periods for sheep (meat and offal) for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solution for injection for subcutaneous use in sheep across the EU, i.e., between 28 days and 107 days.
Maltese: Ġie nnutat li hemm perjodi ta' rtirar approvati differenti għan-nagħaġ (laħam u ġewwieni) għal prodotti mediċinali veterinarji li fihom 50 mg closantel kull ml (bħala sustanza attiva waħda) ippreżentati bħala soluzzjoni għall-injezzjoni għal użu taħt il-ġilda fin-nagħaġ madwar l-UE, jiġifieri, bejn 28 jum u 107 ijiem.
English: • Although there is some uncertainty as to how the differences in formulation would affect the rate of depletion from the injection sites, the injection volumes used in Study 1 were considered to be reasonable worst case due to the weights of the animals used and the mg/kg, rather than mg/animal, dosing regimen, when compared to the recommended weights of animals in VICH GL 482.
Maltese: • Għalkemm hemm xi inċertezza dwar kif id-differenzi fil-formulazzjoni jaffettwaw ir-rata ta' tnaqqis mis-siti tal-injezzjoni, il-volumi ta' injezzjoni użati fl-Istudju 1 tqiesu bħala l-agħar każ raġonevoli minħabba l-piżijiet tal-annimali użati u l-mg/kg, aktar milli mg/annimal, kors ta' dożaġġ, meta mqabbel mal-piżijiet rakkomandati ta' annimali f'VICH GL 482.
English: While the efficacy of the concerned products in sheep has not been specifically assessed as part of this referral, the products under assessment are considered to be effective in the treatment and prevention of infestations with named parasites.
Maltese: Filwaqt li l-effikaċja tal-prodotti kkonċernati fin-nagħaġ ma ġietx speċifikament ivvalutata bħala parti minn din ir-referenza, il-prodotti li qed jiġu vvalutati huma kkunsidrati effettivi fil-kura u l-prevenzjoni ta' infestazzjonijiet b'parassiti msemmija.
English: The recommended doses are 2.5 mg or 5 mg closantel per kg body weight (bw) for cattle and sheep, depending on the parasitic species and/or parasitic life stage at the time of treatment.
Maltese: Id-dożi rakkomandati huma 2.5 mg jew 5 mg closantel għal kull kg ta' piż tal-ġisem (bw) għall-baqar u nnagħaġ, skont l-ispeċijiet parassitiċi u/jew l-istadju tal-ħajja parassitika fil-ħin tal-kura.
English: As a result, a withdrawal period of 107 days was determined, using the ‘alternative' method, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)1.
Maltese: f'konformità man-nota CVMP għal gwida dwar l-approċċ lejn l-armonizzazzjoni tal-perjodi ta' rtirar (EMEA/CVMP/036/95)1.
English: • as data have been provided that demonstrate that the impact of the formulation on the rate of absorption from the injection site is of minor significance compared to the very slow rate of elimination from the other edible tissues, the withdrawal period of 107 days derived in Study 1 can be extrapolated to all concerned products.
Maltese: • peress li ġiet ipprovduta data li turi li l-impatt tal-formulazzjoni fuq ir-rata ta' assorbiment mis-sit tal-injezzjoni huwa ta' sinifikat żgħir meta mqabbel mar-rata bil-mod ħafna ta' eliminazzjoni minn tessuti oħra li jittieklu, il-perjodu ta' tneħħija ta' 107 ijiem derivat fi Studju 1 jista' jiġi estrapolat għall-prodotti kollha kkonċernati.
English: Most (90%) of a dose of closantel is excreted unchanged in the bile/faeces after intramuscular administration, but only 10% within 48 hours, after which the rate slows further so that 1 - 2% of the dose is eliminated each day.
Maltese: Il-biċċa l-kbira (90%) ta' doża ta' closantel titneħħa mhux mibdula fil-bili/ippurgar wara amministrazzjoni ġol-muskoli, iżda 10% biss fi żmien 48 siegħa, wara dan, ir-rata tonqos aktar sabiex 1 - 2% tad-doża tiġi eliminata kuljum.
English: • from the data provided, it is concluded that the full residues depletion study provided for ‘Flukiver 5%' (Study 1) could be considered as the pivotal study, as it was well-reported, and conformed well to current requirements.
Maltese: • mid-data pprovduta, ġie konkluż li l-istudju tat-tnaqqis tar-residwi sħaħ ipprovdut għal 'Flukiver 5%' (Studju 1) jista' jiġi kkunsidrat bħala l-istudju pivotali, peress li kien irrappurtat sew, u kkonforma sew mar-rekwiżiti attwali.
English: Study 2 investigated injection sites only, and the data from this study cannot be compared with, or combined with, the data from Study 1 due to differences in the conduct of the studies.
Maltese: Studju 2 investiga siti ta' injezzjoni biss, u d-data minn dan listudju ma tistax titqabbel ma', jew tiġi kkombinata ma', data mill-Istudju 1 minħabba differenzi fit-tmexxija tal-istudji.
English: The last product is formulated with a large percentage of glycerol formal.
Maltese: L-aħħar prodott huwa fformulat b'perċentwal kbir ta' glycerol formali.
English: Strength
Maltese: Tikkettar
English: Santiola 50 mg/ml Solution for Injection for Cattle and Sheep sheep sheep: subcutaneous
Maltese: Santiola 50 mg/ml Solution for Injection for Cattle and Sheep nagħaġ nagħaġ: taħt ilġilda
English: Overall summary of the scientific evaluation of veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' prodotti mediċinali veterinarji li fihom 50 mg closantel għal kull ml (bħala sustanza attiva waħda) ippreżentat bħala soluzzjonijiet għall-injezzjoni għall-użu taħt il-ġilda finnagħaġ (ara l-Anness I)
English: The first timepoint where all residues are below the authorised MRL is at 89 days, and, with the addition of a safety span of 20% to take into account the variability of depletion between the animals used, a withdrawal period of 107 days is calculated.
Maltese: L-ewwel punt tal-kalendarju fejn ir-residwi kollha huma taħt l-MRL awtorizzat huwa ta' 89 jum, u, biż-żieda ta' medda ta' sigurtà ta' 20% biex titqies il-varjabilità tat-tnaqqis bejn lannimali użati, jiġi kkalkulat perjodu ta' rtirar ta' 107 ijiem.
English: This is considered to be an important parameter affecting the residues at the injection site.
Maltese: Dan huwa kkunsidrat bħala parametru importanti li jaffettwa rresidwi fis-sit tal-injezzjoni.
English: Therefore, the Committee considered that the proposed WP of 107 days derived from Study 1 can be extrapolated to all concerned products.
Maltese: Għalhekk, il-Kumitat ikkunsidra li lperjodu ta' rtirar (WP) propost ta' 107 ijiem derivati mill-Istudju 1 jista' jiġi estrapolat għall-prodotti kollha kkonċernati.
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, route of administration and marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali veterinarji, speċi tal-annimali, ir-rotta talamministrazzjoni, u d-detenturi tal-awtorizzazzjoni għattqegħid fis-suq fl-Istati Membri
English: However, based on the data assessed during this procedure, it is possible to make a recommendation to have a 107-day withdrawal period for sheep (meat and offal) for the concerned products containing 50 mg closantel per ml (as a single active substance) presented as a solution for injection for subcutaneous use in sheep.
Maltese: Madankollu, abbażi tad-data vvalutata matul din il-proċedura, huwa possibbli li ssir rakkomandazzjoni li jkun hemm perjodu ta' rtirar ta' 107 ijiem għan-nagħaġ (laħam u ġewwieni) għall-prodotti kkonċernati li jkun fihom 50 mg closantel kull ml (bħala sustanza attiva waħda) ippreżentat bħala soluzzjoni għall-injezzjoni għal użu taħt il-ġilda finnagħaġ.
English: It is slowly released from plasma and very slowly metabolised, and is therefore retained in the circulation for a long time; the plasma elimination half-life in sheep is 22.7 days.
Maltese: Jiġi rilaxxat bil-mod mill-plażma u jkun metabolizzat bil-mod ħafna, u għalhekk jinżamm fiċ-ċirkolazzjoni għal żmien twil; in-nofs ħajja taleliminazzjoni tal-plażma fin-nagħaġ hija ta' 22.7 ijiem.
English: The analysis of the sheep tissues differed between the two studies, with study 1 using LC-MS/MS as their analytical method, and study two using HPLC-FD.
Maltese: L-analiżi tat-tessuti tan-nagħaġ kienet differenti bejn iż-żewġ studji, bl-istudju 1 uża LC-MS/MS bħala l-metodu analitiku tagħhom, u studju tnejn uża HPLC-FD.
English: The specified pH of the products used in studies 1 and 2 were in the same range; the effect of pH to explain any differences can thus be ruled out.
Maltese: Il-pH speċifikat tal-prodotti użati fi studji 1 u 2 kienu fl-istess medda; l-effett tal-pH biex jispjega kwalunkwe differenza jista' għalhekk jiġi eskluż.
English: • Although there is some uncertainty as to how the differences in formulation would affect the rate of depletion from the injection sites, the injection volumes used in Study 1 were considered to be reasonable worst case, due to the weights of the animals used, and the mg/kg dosing regimen, when compared to the recommended weights of animals in VICH GL 48.
Maltese: • Għalkemm hemm xi inċertezza dwar kif id-differenzi fil-formulazzjoni jaffettwaw ir-rata ta' tnaqqis mis-siti tal-injezzjoni, il-volumi ta' injezzjoni użati fl-Istudju 1 tqiesu bħala l-agħar każ raġonevoli minħabba l-piżijiet tal-annimali użati, u l-mg/kg fil-kors ta' dożaġġ, meta mqabbel mal-piżijiet rakkomandati ta' annimali f'VICH GL 48.
English: The study was conducted in 2009, with 30 treated animals (5 mixed-sex groups of six animals) and a control group consisting of one untreated animal.
Maltese: L-istudju sar fl-2009, bi 30 annimal ikkurat (ħames gruppi ta' sitt annimali-ta' sess imħallat) u grupp ta' kontroll magħmul minn annimal wieħed mhux ikkurat.
English: • The tissue-specific withdrawal period determined from Study 1 for liver was 28 days longer than that for injection sites, which leaves a suitably long time for any additional injection site residues to deplete before the 107-day withdrawal period is complete.
Maltese: • Il-perjodu ta' rtirar speċifiku għat-tessut determinat mill-Istudju 1 għall-fwied kien ta' 28 jum itwal minn dak għal siti ta' injezzjoni, li jħalli żmien twil biżżejjed biex kwalunkwe residwu addizzjonali fis-sit tal-injezzjoni jispiċċa qabel il-perjodu tal-irtirar ta' 107 ijiem ikun komplut.
English: However, considering the results of this pilot study, and the limited information that they provide, this conclusion might not be adequate, as the residue concentrations in the sampled tissues did not fall below the respective MRLs; therefore, it was not possible to know which would be the withdrawal period determining tissue from these data.
Maltese: Madankollu, meta jitqiesu r-riżultati ta' dan l-istudju pilota, u l-informazzjoni limitata li jipprovdu, din il-konklużjoni tista' ma tkunx adegwata, billi l-konċentrazzjonijiet ta' residwi fit-tessuti inklużi fil-kampjun ma jaqgħux taħt l-MRLs rispettivi; għalhekk, ma kienx possibbli li tkun taf liema jkun it-tessut li jiddetermina l-perjodu ta' rtirar minn din id-data.
English: Two of the product formulations are very similar, being solutions with similar excipients, and using a similar proportion of water and propylene glycol as the vehicle.
Maltese: Tnejn mill-formulazzjonijiet tal-prodott huma simili ħafna, billi huma soluzzjonijiet b'eċċipjenti simili, u jużaw proporzjon simili ta' ilma u propylene glycol bħala vettur.
English: The available data demonstrate that the liver is the withdrawal period determining tissue and that the rate of elimination from edible tissues would not be influenced by the rate of absorption from the injection site and thereby impacted by product formulation.
Maltese: Id-data disponibbli turi li l-fwied huwa t-tessut li jiddetermina l-perjodu ta' rtirar u li r-rata ta' eliminazzjoni minn tessuti li jittieklu ma tkunx influwenzata mir-rata ta' assorbiment mis-sit talinjezzjoni u b'hekk tiġi affettwata mill-formulazzjoni tal-prodott.