FrancophonIA/ELRC3.0 huggingface dataset:
English: In a GLP challenge study, pigs were treated with the recommended 10 mg/kg bw dose, but for 21 days instead of 7 days.
Maltese: Fi studju ta' sfida GLP, il-majjali kienu kkurati bid-doża rakkomandata ta' 10 mg/kg, iżda għal 21 jum minflok 7 ijiem.
English: The in vitro susceptibility data for Escherichia coli and Salmonella were not extensive but among them there were data from a newly conducted good laboratory practice (GLP)-compliant pan-European MIC survey involving 100 E. coli and 100 Salmonella isolates from clinical cases.
Maltese: Id-dejta dwar is-suxxettibiltà in vitro għal Escherichia coli u Salmonella ma kinitx estensiva iżda fostha kien hemm dejta minn stħarriġ MIC pan-Ewropew konformi ma' prattika laboratorja tajba (GLP) li għadu kif jitwettaq li jinvolvi iżolati ta' 100 E. coli u 100 Salmonella minn każijiet kliniċi.
English: Spectinomycin
Maltese: Spektinomiċina
English: This amounts to 75 mg powder/kg bw/day for 7 days.
Maltese: Dan jammonta għal 75 mg trab/kg piż tal-ġisem/jum għal 7 ijiem.
English: For the treatment and prevention of dysentery caused by Brachyspira hyodysenteria and for the treatment and prevention of ileitis (porcine proliferative enteropathy) caused by Lawsonia intracellularis, and associated enteric pathogens (Escherichia coli).
Maltese: Qżieqeż Għat-trattament u l-prevenzjoni ta' diżenterija kaġunata minn Brachyspira hyodysenteria u għat trattament u l-prevenzjoni ta' ilejite (enteropatija proliferattiva tal-ħnieżer) ikkaġunata minn Lawsonia intracellularis, u l-patoġeni enteriċi assoċjati (Escherichia coli).
English: In a newly provided GCP challenge study the product used at 50 mg/kg bw/day for 7 days was shown to be effective in reducing clinical signs, lesions and bacteriological re-isolation associated to E. coli and/or M. gallisepticum experimental infection in chickens, although the bacterial re-isolation rate was high, with a non-statistically significant reduction for E. coli, and the MIC of the infective strains was low when compared to most field strains.
Maltese: Fi studju tal-GCP ipprovdut ġdid ta' stimolazzjoni tar-rispons immunoloġiku, intwera li l-prodott użat b'50 mg/kg bw/jum għal 7 ijiem huwa effettiv biex inaqqas is-sinjali kliniċi, ġrieħi u riiżolazzjoni batterjoloġika assoċjata ma' infezzjoni sperimentali ta' E. coli u/jew M. gallisepticum fit-tiġieġ, għad li r-rata ta' riiżolazzjoni batterjali kienet għolja, bi tnaqqis mhux statistikament sinifikanti għal E. coli, u l-MIC tar-razez infettivi kienet baxxa meta mqabbla ma' ħafna mir-razez fuq il-post.
English: In chicken the product is already indicated in many EU Member States for the treatment of CRD, associated to Mycoplasma and/or E. coli.
Maltese: Fit-tiġieġ il-prodott diġà huwa indikat f'ħafna Stati Membri tal-UE għall-kura tas-CRD, assoċjata ma' Mycoplasma u/jew E. coli.
English: However, the used dosing regimens were very unclear and possibly range from the proposed dose of 50 mg/kg bw/day to the highest approved dose of 150 mg/kg bw.
Maltese: Madankollu, id-dożaġġ użat ma kienx ċar u possibbilment ivarja mid-doża proposta ta' 50 mg/kg bw/jum sal-ogħla doża approvata ta' 150 mg/kg bw.
English: After an overall assessment in the context of the harmonisation of an already approved product, and for the reasons listed below, the CVMP considered that 50 mg/kg bw for 7 days can be accepted as the harmonised dose in chickens:
Maltese: Wara valutazzjoni ġenerali fil-kuntest tal-armonizzazzjoni ta' prodott diġà approvat, u għar-raġunijiet elenkati hawn taħt, is-CVMP qies li 50 mg/kg bw għal 7 ijiem tista' tiġi aċċettata bħala d-doża armonizzata fit-tiġieġ:
English: Disposal: read package leaflet.
Maltese: Qżieqes: għallgħoti permezz tal-ilma taxxorb.
English: Lincomycin binds to the 50S sub-unit of the bacterial ribosome close to the peptidyl transfer centre and interferes with the peptide chain elongation process by inhibiting the formation of the 50S sub-unit and by stimulating ribosomal peptidyl-tRNA dissociation.
Maltese: Linkomiċina jintrabat mas-sottounità 50S tar-ribosomu batteriku qrib iċ-ċentru ta' trasferiment tal-pepidyl u jinterferixxi mal-proċess tat-titwil tal-katina tal-peptide billi jimpedixxi lformazzjoni tas-sottounità 50S u billi jistimula d-disassoċjazzjoni ribosomali ta' peptidyl-tRNA.
English: On the basis of in vitro tests, it has been hypothesised that a metabolite or degradation product of spectinomycin was produced in the gut and was able to reach the infection site and interfere with E. coli adherence to the respiratory mucosa, but this has not been validated (Goren et al., 1988)2.
Maltese: Fuq il-bażi tat-testijiet in vitro, ġie ipotizzat li metabolit jew prodott ta' degradazzjoni ta' spettinomiċina ġie prodott fl-imsaren u rnexxilu jilħaq is-sit tal-infezzjoni u jinterferixxi mal-aderenza ta' E. coli għall-membrana mukuża respiratorja, iżda dan ma ġiex validat (Goren et al., 1988)2.
English: Turkeys
Maltese: Majjali
English: Cmax occurred at 4 hours after introduction of the medicated water.
Maltese: Cmax seħħ 4 sigħat wara l-introduzzjoni tal-ilma medikat.
English: Pharmacovigilance reports have not reported a lack of efficacy of Linco-Spectin 100 in the proposed harmonised indication in chicken.
Maltese: Ir-rapporti ta' farmakoviġilanza ma semmewx nuqqas ta' effikaċja ta' Linco-Spectin 100 fl-indikazzjoni armonizzata proposta fit-tiġieġ.
English: “Product name (to be completed nationally)” is a combination of two antibiotics, lincomycin and spectinomycin, having a complementary spectrum of activity.
Maltese: “Isem il-prodott (għandu jimtela fil-pajjiż stess)” huwa kombinazzjoni ta' żewġ antibijotiċi, linkomiċina u spektinomiċina, li għandhom spettru kumplimentari ta' attivita.
English: Lincomycin (as lincomycin hydrochloride)
Maltese: Linkomiċina (bħala linkomiċina hydrochloride)
English: Chickens Turkeys Duck Pigeon
Maltese: Qżieqes Tjur (li ma jqegħdux bajd)
English: * A dose of 50 mg/kg bw is the most frequent recommendation for “treatment” among the concerned SPCs.
Maltese: • Doża ta' 50 mg/kg bw hija l-iktar rakkomandazzjoni spissa għal “kura” fost l-SPCs ikkonċernati.
English: The indication for swine dysentery caused by Brachyspira hyodysenteriae and associated pathogens was substantiated trough a review of literature and old proprietary in vitro susceptibility data, a newly conducted B. hyodysenteriae MIC survey, and old clinical studies.
Maltese: L-indikazzjoni għal diżenterija tal-majjali kkawżata minn Brachyspira hyodysenteriae u patoġeni assoċjati ġiet sostanzjata permezz ta' analiżi tad-dokumenti u dejta dwar is-suxxettibilità in vitro antika proprjetarja, stħarriġ tal-MIC ta' B. hyodysenteriae li għadu kif sar, u studji kliniċi qodma.
English: In E. coli and Salmonella spp.
Maltese: F'E. coli u l-ispp. ta' Salmonella il-firxa
English: “For the treatment and prevention of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum and Escherichia coli, and associated with a low mortality rate.
Maltese: “Għall-kura u l-prevenzjoni ta' mard respiratorju kroniku (CRD) ikkaġunat minn Mycoplasma gallisepticum u Escherichia coli, u assoċjat ma' rata ta' mortalità baxxa.
English: Overall and considering also the older literature data, a rate of clinical resistance of at least 10% was suggested.
Maltese: B'mod ġenerali, u wara li tiġi kkunsidrata wkoll id-dejta minn tagħrif eqdem, ġiet suġġerita rata ta' reżistenza klinika ta' tal-inqas 10%.
English: 10,000 x [daily water consumption per animal (L)] average body weight of one pig (kg) In pigs 150 g of the veterinary medicinal product corresponds to the dose for 10,000 kg of body weight per day.
Maltese: Fil-qżieqeż 150 g ta' prodott mediċinali veterinarju jikkorispondi għad-doża għal 10,000 kg ta' piż talġisem kuljum.
English: In support of the indication for proliferative enteropathy caused by Lawsonia intracellularis, a literature review on in vitro susceptibility data was provided, as well as two older clinical efficacy studies.
Maltese: Bħala appoġġ tal-indikazzjoni għal enteropatija proliferattiva kkawżata minn Lawsonia intracellularis, kienet ipprovduta reviżjoni tal-letteratura dwar id-dejta tas-suxxettibilità in vitro, kif ukoll żewġ studji dwar l-effikaċja klinika aktar antiki.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamla farmaċewtika (għamliet farmaċewtiċi), qawwiet tal-prodotti mediċinali veterinarji, speċi tal-annimali, mnejn jingħata, Id-Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq fl-Istati Membri
English: In the proposed harmonised SPC all references to prophylactic treatment were deleted, which was confirmed by the CVMP.
Maltese: Fl-SPC armonizzat propost, tħassru r-referenzi kollha għal kura profilattika, li ġiet ikkonfermata misCVMP.
English: Pharmacovigilance reports have not reported a lack of efficacy of Linco-Spectin 100 in the recommended harmonised indications in pigs.
Maltese: Ir-rapporti tal-farmakoviġilanza ma semmewx nuqqas ta' effikaċja ta' Linco-Spectin 100 flindikazzjonijiet armonizzati rakkomandati għall-majjali.
English: A single oral administration of lincomycin hydrochloride, at dose levels of approximately 22, 55 and 100 mg/kg body weight in pigs, resulted in dose related lincomycin serum levels, detected for 24-36 hours after administration.
Maltese: Għotja orali waħda ta' linkomiċina hydrochloride, f'livelli ta' dożi ta' madwar 22, 55 u 100 mg/kg piż tal-ġisem fil-qżieqeż, irriżulta f'livelli ta' linkomiċina fis-serum relatati mad-doża, osservati għal 24-36 siegħa wara l-għoti.
English: Lincomycin is a lincosamide antibiotic, closely related to macrolide and streptogramin B antimicrobials.
Maltese: Lincomycin huwa antibijotiku lincosamide, relatat mill-qrib mal-antimikrobiċi macrolide u streptogramin B. Jinibixxi s-sinteżi tal-proteini permezz tat-twaħħil mas-sottaunità ta' ribosoma batterika 50S.
English: In a newly provided GCP-compliant challenge study the product used at 50 mg/kg/day for 7 days was shown to be effective in reducing clinical signs and lesions associated with E. coli and/or M. gallisepticum experimental infection in chickens, although the bacterial re-isolation rate was high - and its reduction was non statistically significant for E. coli - and the MIC values of the infective strains were at the very lower end of the range determined in the MIC surveys.
Maltese: Fi studju ta' stimolazzjoni tar-rispons immunoloġiku konformi mal-GCP li għadu kif ġie pprovdut, intwera li l-prodott użat b'50 mg/kg/jum għal 7 ijiem huwa effettiv fit-tnaqqis tas-sinjali kliniċi u l-ġrieħi assoċjati ma' infezzjoni sperimentali ta' E. coli u/jew M. gallisepticum fittiġieġ, għad li r-rata ta' riiżolament batterjali kienet għolja - u t-tnaqqis tagħha ma kienx statistikament sinifikanti għal E. coli - u l-valuri tal-MIC tar-razez infettivi kienu fil-qiegħ nett tal-medda determinata fl-istħarriġijiet tal-MIC.
English: This amounts to 15 mg powder/kg bw/day for 7 days.
Maltese: Dan jammonta għal 15 mg trab/kg piż tal-ġisem/jum għal 7 ijiem.
English: Spectinomycin is an aminocyclitol antibiotic derived from Streptomyces spectabilis, it has bacteriostatic activity and is active against Mycoplasma spp.
Maltese: Spektinomiċina L-iSpektinomiċina hija antibijotiku aminoċiklitol li jiġi minn Streptomyces spectabilis, għandu attività batterjostatika u huwa attiv kontra Mycoplasma spp. u kontra xi batterja gram-negattivi bħal E. coli.
English: There is no evidence that this situation is evolving.
Maltese: Ma hemm ebda evidenza li din is-sitwazzjoni qed tevolvi.
English: In chickens treated with “product name (to be completed nationally)” in drinking water at the target dose of 50 mg/kg body weight of total activity (at a ratio of 1:2 lincomycin:spectinomycin) for seven consecutive days, Cmax after first offering of medicated water was calculated to be 0.0631 µg/ml.
Maltese: F'tiġieġ ittrattati b'“isem il-prodott (għandu jimtela fil-pajjiż stess)” f'ilma tax-xorb bid-doża fil-mira ta' 50 mg/kg piż tal-ġisem ta' attività totali (bi proporzjon ta' 1:2 linkomiċina:spektinomiċina) għal sebat ijiem konsekuttivi, Cmax wara l-ewwel offerti ta' ilma mmedikat kien ikkalkulat li jkun 0.0631 µg/ml.
English: Ingestion by these species may result in severe gastrointestinal effects.
Maltese: L-inġestjoni minn dawn l-ispeċi tista‘ tirriżulta f‘effetti gastrointestinali severi.
English: INDICATION(S)
Maltese: INDIKAZZJONI(JIET)
English: * The inclusion of information about resistance status and warnings about prudent use as regards resistance, in SPC sections 4.4 Special warnings for each target species, 4.5 (i) Special precautions for use in animals and 5.1 Pharmacodynamic properties.
Maltese: • L-inklużjoni ta' tagħrif dwar l-istatus tar-reżistenza u twissijiet fuq użu prudenti fir-rigward tarreżistenza, fit-taqsimiet tal-SPC 4.4 Twissijiet speċjali għal kull speċi fil-mira, 4.5 (i) Prekawzjonijiet speċjali għall-użu f'annimali u 5
English: NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name> 222 mg/g + 444.7 mg/g powder for use in drinking water for pigs and chickens
Maltese: VETERINARJU <Isem ivvintat> 222 mg/g + 444.7 mg/g trab għal użu f'ilma tax-xorb għal qżieqeż u tiġieġ
English: Although the mechanism of action at the systemic level of spectinomycin administered orally is not elucidated, its clinical benefit and the benefit of the combination seems to be demonstrated in several older laboratory challenge studies; however, the dosing regimens applied in these studies can only be estimated and likely range from the harmonised dose of 50 mg/kg bw/day to at least the highest approved dose of 150 mg/kg bw/day.
Maltese: Għad li l-mekkaniżmu tal-azzjoni fil-livell sistemiku ta' spettinomiċina amministrata b'mod orali mhuwiex iċċarat, il-benefiċċji kliniku tiegħu u l-benefiċċju tat-taħlita jidhru li ntwerew f'bosta studji tallaboratorju eqdem ta' stimolazzjoni tar-rispons immunoloġiku; madankollu, l-iskemi tad-dożaġġ applikati f'dawn l-istudji jistgħu jiġu stmati biss u aktarx ivarjaw mid-doża armonizzata ta' 50 mg/kg bw/jum sa tal-inqas l-ogħla doża approvata ta' 150 mg/kg bw/jum.
English: Pigs:
Maltese: Tjur:
English: Although the scarce data available indicates that in vitro activity of the active substances against L. intracellularis is poor, considering the well-established use of the product in the EU and that the pharmacovigilance reports do not show any reports for lack of efficacy, it can be argued that the clinical situation is not directly correlated with the clinical efficacy of the product.
Maltese: Għalkemm id-dejta skarsa disponibbli tindika li attività in vitro tas-sustanzi attivi kontra L. intracellularis hija limitata, fid-dawl tal-użu stabbilit sew tal-prodott fl-UE u li r-rapporti ta' farmakoviġilanza ma juru ebda rapport ta' nuqqas ta' effikaċja, jista' jiġi argumentat li s-sitwazzjoni klinika mhijiex direttament korrelata mal-effikaċja klinika tal-prodott.
English: Clinical efficacy in swine dysentery at a dosing regimen close to the recommended harmonised regimen of 10 mg/kg bw for 7 days is supported by older laboratory and field clinical studies, despite the fact that these are not GLP or GCP-compliant and that the clinical and bacteriological criteria for inclusion are not always precisely defined in the study reports.
Maltese: L-effikaċja klinika f'disinterija tal-majjali fi skema tad-dożaġġ qrib l-iskema armonizzata rakkomandata ta' 10 mg/kg bw għal 7 ijiem hija sostnuta minn studji tal-laboratorju u kliniċi fuq il-post eqdem, minkejja l-fatt li dawn mhumiex konformi mal-GLP jew il-GCP u li l-kriterji kliniċi u batterjoloġiċi għallinklużjoni mhumiex dejjem definiti bi preċiżjoni fir-rapporti tal-istudji.
English: Oral Powder
Maltese: Trab orali
English: Resistance can be a direct concern when affecting zoonotic pathogens such as Campylobacter and Enterococcus, or can be transferred horizontally to human pathogens via mobile genetic elements.
Maltese: Ir-reżistenza tista' tkun ta' tħassib dirett meta taffettwa patoġeni zoonotiċi bħal Campylobacter u Enterococcus, jew tista' tiġi ttrasferita b'mod orizzontali f'patoġeni tal-bniedem permezz ta' elementi ġenetiċi mobbli.
English: Also in one of the field studies the target condition was a mixed enteric and respiratory infection involving Salmonella and Mycoplasma, which is only poorly relevant to the claimed indication.
Maltese: Barra minn hekk, f'wieħed mill-istudji prattiċi, il-kundizzjoni fil-mira kienet infezzjoni respiratorja enterika u mħallta li tinvolvi Salmonella u Mycoplasma, li ma tantx hija rilevanti għall-indikazzjoni allegata.
English: This is indicative of a significant rate of high-level resistance although no firm clinical breakpoint has been set.
Maltese: Dan huwa indikattiv ta' rata sinifikanti ta' reżistenza ta' livell għoli għalkemm ma ġie stabbilit ebda breakpoint kliniku sod.
English: Chromosomal one-step mutation to high-level spectinomycin resistance develops in many enteric bacteria (such as E. coli).
Maltese: Mutazzjoni kromosomali ta' stadju wieħed għal-livell għoli ta' reżistenza b'spektinomiċina jiżviluppa f'ħafna batterja enterika (bħal E. coli).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottles containing 150 g or 1.5 kg and tub containing 4.5 kg
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT LI JMISS MAL-PRODOTT Fliexken li fihom 150 g jew 1.5 kg u reċipjent li fih 4.5 kg.
English: In E. coli, a significant part of the strains show high MIC values (minimum inhibitory concentrations) against the lincospectin-spectinomycin combination and may be clinically resistant, although no breakpoint is defined.
Maltese: (minimum inhibitory concentrations, MIC) kontra l-kombinazzjoni ta linkomiċina-spektinomiċina u jista‘ jkun klinikament reżistenti, għalkemm l-ebda punt ta‘ riferiment ma ġie mfisser.
English: Withdrawal period:
Maltese: Tqala u treddigħ:
English: No recent
Maltese: 5 ijiem
English: Clinical efficacy at the proposed dosing regimen of 10 mg/kg body weight (bw) for 7 days in swine dysentery was supported by two duplicate trials in laboratory conditions, and by two field clinical studies.
Maltese: L-effikaċja klinika fil-kors ta' dożaġġ propost ta' 10 mg/kg piż tal-ġisem (bw) għal 7 ijiem fid-diżenterija tal-majjali kienet appoġġjata minn żewġ provi duplikati f'kundizzjonijiet tal-laboratorju, u minn żewġ studji kliniċi fuq il-post.
English: The proposed withdrawal time of 5 days is considered sufficient by the CVMP when chickens are treated using the proposed harmonised dosing regimen 50 mg/kg bw/day for 7 days.
Maltese: Iż-żmien ta' eliminazzjoni propost ta' 5 ijiem tqies biżżejjed misCVMP meta t-tiġieġ jiġu kkurati billi tintuża l-iskema tad-dożaġġ armonizzata proposta ta' 50 mg/kg bw/jum għal 7 ijiem.
English: Use only accordingly to benefit-risk assessment by the responsible veterinarian.
Maltese: Uża biss skont il-valutazzjoni tal-benefiċċju u r-riskju mill-veterinarju responsabbli.
English: Animals must not be slaughtered for human consumption during treatment.
Maltese: Annimali m'għandhomx jiġi maqtula għal konsum uman waqt it-trattament.
English: The most frequent dosing recommendation for treatment is 50 mg/kg bw/day; few SPCs recommend 150 mg/kg bw and some other ones give only a concentration in water, which corresponds approximately to 50 mg/kg bw.
Maltese: L-iktar rakkomandazzjoni tad-dożaġġ spissa għall-kura hija dik ta' 50 mg/kg bw/jum; ftit SPCs irrakkomandaw 150 mg/kg bw u oħrajn taw biss konċentrazzjoni fl-ilma, li tikkorrispondi għal madwar 50 mg/kg bw.
English: In a GCP-compliant, multicentre field study, pigs were treated as recommended and medication with Linco-Spectin 100 for 7 and 14 days was efficacious for the treatment of ileitis in pigs; there was no benefit of treating pigs suffering from ileitis longer than 7 days.
Maltese: Fi studju tal-qasam multiċentrali, konformi ma' GCP, il-majjali kienu kkurati kif rakkomandat u l-medikazzjoni b'Linco-Spectin 100 għal 7 u 14-il jum kienet effikaċi għal kura ta' ileite fil-majjali; ma kien hemm l-ebda benefiċċju mill-kura ta' majjali li jsofru minn ileite itwal minn 7 ijiem.
English: This might be due partly to natural resistance.
Maltese: Dan jista' jkun parzjalment dovut għal reżistenza naturali.
English: 0.2 L/kg bw/day
Maltese: .2 L/kg piż tal ġisem/jum2,000 L ta' ilma għax-xorb
English: Strength Pharmaceutical form
Maltese: Għamla farmaċewtika
English: Pigs Chicken (broiler, pullet) Turkey
Maltese: Qżieqes Tiġieġ (grojlet, għattuq) Dundjan
English: The combination lincomycin-spectinomycin was also shown to be superior to each individual active substance.
Maltese: Intwera wkoll li l-kombinazzjoni ta' lincomycin-spectinomycin hija wkoll superjuri għal kull sustanza attiva individwali.
English: Chickens
Maltese: Qawwa
English: Do not use in laying hens.
Maltese: • Perjodi ta' tiżmim.
English: 1,000 L of drinking water
Maltese: 1,000 L ta' ilma għax-xorb
English: * There are no new clinical trials, field trials or publications demonstrating the effectiveness of the lincomycin-spectinomycin combination against modern outbreaks of swine dysentery, and based on current approved dosing regimens.
Maltese: • M'hemm l-ebda prova klinika, prova tal-qasam jew pubblikazzjoni ġdida li turi l-effikaċja talkombinazzjoni ta' lincomycin u spectinomycin kontra tifqigħat moderni ta' diżenterija tal-majjali, u abbażi tal-korsijiet ta' dożaġġ attwali approvati.
English: Studies performed in various animal species have demonstrated that spectinomycin undergoes limited absorption from the intestine (less than 4-7%) after oral administration.
Maltese: Studji li saru f'diversi speċi t'annimali wrew li spektinomiċina jkolla assorbiment limitat mill-imsaren (inqas minn 4-7%) wara l-għoti mill-ħalq.
English: Do not store above 25 °C.
Maltese: Taħżinx f'temperatura ogħla minn 25 C.
English: White HDPE bottle containing 150 g or 1.5 kg powder for oral solution with a white tamper evident LDPE lid.
Maltese: Flixkun abjad ta' HDPE li fih 150 jew 1.5 kg trab għal soluzzjoni orali b'għatu abjad ta' LDPE li jħalli evidenza f'każ ta' tbagħbis.
English: The average of the half-lives of elimination of all routes of administration is 2.82 hours in pigs.
Maltese: Il-medja tal-half-lives ta' eliminazzjoni mir-rotot kollha tal-għoti hi ta' 2.83 sigħat fil-qżieqeż.
English: As an indication, standard water intake varies around 0.15 L/kg bw/day.
Maltese: Bħala indikazzjoni, teħid tal-ilma standard ivarja madwar 0.15
English: 0.15 L/kg bw/day
Maltese: L/kg/piż tal-ġisem/jum.
English: However, no precise clinical breakpoint has been established and from the data provided it seems that in vitro susceptibility was not correlated to clinical efficacy.
Maltese: Madankollu, ma ġie stabbilit ebda breakpoint kliniku preċiż u middejta pprovduta jidher li s-suxxettibilità in vitro ma kinitx ikkorelatata mal-effikaċja klinika.
English: The proposed withdrawal time of 0 days was well supported by a residue study where pigs were treated using the proposed harmonised dosing regimen 10 mg/kg bw/day for 7 days, and is considered acceptable by the CVMP.
Maltese: Iż-żmien ta' rtirar propost ta' 0 jiem kien ukoll appoġġjat sew minn studju dwar ir-residwi fejn il-majjali ġew ikkurati bl-użu tal-kors ta' dożaġġ armonizzat propost ta' 10 mg/kg bw/jum għal 7 ijiem, u dan huwa meqjus aċċettabbli mis-CVMP.
English: Consumer safety remains ensured by the recommended harmonised withdrawal periods of 0 days in pig and 5 days in chickens.
Maltese: Is-sikurezza tal-konsumaturi għadha ggarantita mill-perjodi ta' tneħħija armonizzati rakkomandati ta' 0 jiem fil-majjali u 5 ijiem fit-tiġieġ.
English: Although this risk has not been unequivocally assessed, the possibility of impact on human health through cross-resistance to clindamycin and other substances of the macrolides, lincosamides and streptogramins (MLS) group is a reality.
Maltese: Għad li dan ir-riskju ma ġiex ivvalutat b'mod assolut, il-possibbiltà ta' impatt fuq is-saħħa tal-bniedem permezz ta' kontroreżistenza għal klindamiċina u sustanzi oħrajn tal-grupp ta' makrolidi, linkosamidi u streptogramini (MLS) hija realtà.
English: Benefit-Risk assessment
Maltese: Valutazzjoni tar-riskji