FrancophonIA/ELRC3.0 huggingface dataset:
English: Spectinomycin is an aminocyclitol antibiotic derived from Streptomyces spectabilis; it has bacteriostatic activity and is active against some aerobic gram-negative bacteria, gram-positive cocci and Mycoplasma spp.
Maltese: Spectinomycin huwa antibijotiku aminocyclitol derivat minn Streptomyces spectabilis; huwa għandu attività batterjostatika u huwa attiv kontra xi batterji aerobiċi gram-negattivi, kokki gram-pożittivi u Mycoplasma spp.
English: Add, to all products and delete the existing text: 5.1 Pharmacodynamic properties
Maltese: Żid, għall-prodotti kollha u ħassar it-test eżistenti: 5.1 Kwalitajiet farmakodinamiċi
English: SPECTINOMYCINE 4.4 PORC FRANVET
Maltese: SPECTINOMYCINE 4.4
English: For the treatment and metaphylaxis of porcine proliferative enteropathy (ileitis) caused by Lawsonia intracellularis, and associated enteric pathogens (Escherichia coli) susceptible to lincomycin and spectinomycin.
Maltese: Għat-trattament u l-metafilassi ta' enteropatija proliferattiva tal-ħnieżer (ilejite) ikkaġunata minn Lawsonia intracellularis, u patoġeni enteriċi assoċjati (Escherichia coli) suxxettibbli għal-lincomycin u lispectinomycin.
English: Delete, where applicable, any references to systematic/prophylactic use.
Maltese: Ħassar, fejn applikabbli, kwalunkwe referenza għall-użu sistematiku/profilattiku.
English: 1 under Article 34 of Directive 2001/82/EC, the product information was harmonised for Linco-Spectin 100, powder for use in drinking water for pigs and chickens, containing 222 mg lincomycin/g and 444.7 mg spectinomycin/g.
Maltese: 1 skont l-Artikolu 34 tad-Direttiva 2001/82/KE, ġiet armonizzata l-informazzjoni dwar il-prodott għal Linco-Spectin 100, trab għall-użu fl-ilma tax-xorb għall-ħnieżer u t-tiġieġ, li fih 222 mg lincomycin/g u 444.7 mg spectinomycin/g.
English: Pigs, poultry (broiler, pullet) and turkey
Maltese: Ħnieżer, tjur (brojler, tiġieġ ta' anqas minn sena) u dundjani
English: Animed Service AG Liebochstrasse 9 8143 Dobl Austria
Maltese: L-Awstrija Animed Service AG Liebochstrasse 9
English: Matije Gupca 42 43500 Daruvar Croatia
Maltese: Matije Gupca 42
English: Linko-spectin 44 premix Lincomycin and Spectinomycin
Maltese: Linko-spectin 44 premix Lincomycin u Spectinomycin
English: Lincomycin is active against gram-positive bacteria, some anaerobic gram-negative bacteria and Mycoplasma spp.
Maltese: Lincomycin huwa attiv kontra batterji gram-pożittivi, xi batterji anerobiċi gram-negattivi u Mycoplasma spp.
English: During the Article 34 referral procedure (EMA/V/A/088) for Linco-Spectin 100, the limited efficacy data that were provided and the lack of residue data did not lead to the approval of any harmonised indications in poultry species other than chickens.
Maltese: Waqt il-proċedura ta' riferiment skont l-Artikolu 34 (EMA/V/A/088) għal Linco-Spectin 100, id-data limitata dwar l-effikaċja li kienet ipprovduta u n-nuqqas ta' data dwar ir-residwi ma wasslu għallapprovazzjoni tal-ebda indikazzjoni armonizzata fi speċi tat-tjur għajr it-tiġieġ.
English: Podružnica Zagreb za promidžbu Petra Hektorovića 2 10000 Zagreb Croatia
Maltese: Podružnica Zagreb za promidžbu
English: Linco-Spectin 44 Premix Lincomycin and Spectinomycin
Maltese: Linco-Spectin 44 Premix Lincomycin u Spectinomycin
English: Pigs, hens pigeons, ducks, turkeys
Maltese: Ħnieżer, tiġieġ ħamiem, papri, dundjani
English: It has little or no action against gram-negative bacteria such as Escherichia coli.
Maltese: Għandu ftit jew ma għandu l-ebda azzjoni kontra batterji gram-negattivi bħall-Escherichia coli.
English: Therefore, on 5 May 2015, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry.
Maltese: Għalhekk, fil-5 ta' Mejju 2015, il-Belġju beda proċedura skont l-Artikolu 35 tad-Direttiva 2001/82/KE għall-prodotti mediċinali veterinarji li fihom kombinazzjoni ta' lincomycin u spectinomycin biex jingħataw b'mod orali lill-ħnieżer u/jew lit-tjur.
English: This study showed that, overall, the lincomycin-spectinomycin combination significantly improved the tested clinical, pathological and bacteriological endpoints in an experimental model of aerosol infection, at a dose of 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw (50 mg combined actives/kg bw) per day for 7 days.
Maltese: Dan l-istudju wera li, b'mod ġenerali, il-kombinazzjoni lincomycin-spectinomycin tejbet b'mod sinifikanti l-punti ta' tmiem kliniċi, patoloġiċi u batterjoloġiċi ttestjati f'mudell sperimentali ta' infezzjoni bl-aerosols, b'doża ta' 16.65 mg lincomycin u 33.35 mg spectinomycin/kg tal-piż tal-ġisem (50 mg ta' sustanzi attivi kombinati/kg tal-piż tal-ġisem) kuljum għal 7 ijiem.
English: Despite the poor in vitro activity of the active substances against L. intracellularis, which appears from the scarce data available, the results of a relatively recent, multicentric field study support efficacy of the lincomycin-spectinomycin combination at a dose of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day for 7 days in drinking water.
Maltese: Minkejja l-attività in vitro batuta tas-sustanzi attivi kontra L. intracellularis, li tidher mid-data skarsa disponibbli, ir-riżultati ta' studju fil-kamp multiċentriku, relattivament riċenti, jappoġġaw l-effikaċja talkombinazzjoni lincomycin-spectinomycin f'doża ta' 3.33 mg lincomycin u 6.67 mg spectinomycin/kg tal-piż tal-ġisem/jum għal 7 ijiem fl-ilma tax-xorb.
English: Lincomycin is active against gram-positive bacteria, some anaerobic gram-negative bacteria and mycoplasmas.
Maltese: Lincomycin huwa attiv kontra batterji gram-pożittivi, xi batterji anerobiċi gram-negattivi u mikoplażmi.
English: 2 under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs, the CVMP recommended the indication ‘swine dysentery caused by B. hyodysenteriae' to be deleted from the http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Veterinary_medicinal_products_cont aining_tylosin_to_be_administered_orally_via_feed_or_the_drinking_water_to_pigs/vet_referral_000098.jsp&mid=WC0b01 ac05805c5170
Maltese: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Veterinary_medicinal_products_cont aining_tylosin_to_be_administered_orally_via_feed_or_the_drinking_water_to_pigs/vet_referral_000098.jsp&mid=WC0b01 ac05805c5170
English: Most available clinical efficacy data relate to administration of the combination as powder for use in drinking water; those from the basis for the harmonised dosing regimen of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day for 7 days for Linco-Spectin 100, as approved during the Article 34 referral procedure (EMEA/V/A/088).
Maltese: Ħafna mid-data disponibbli dwar l-effikaċja klinika tirrigwarda l-għoti tal-kombinazzjoni bħala trab għall-użu fl-ilma tax-xorb; din tifforma l-bażi għar-reġim ta' dożaġġ armonizzat ta' 3.33 mg lincomycin u 6.67 mg spectinomycin/kg tal-piż tal-ġisem/jum għal 7 ijiem għal Linco-Spectin 100, kif approvat waqt il-proċedura ta' riferiment skont l-Artikolu 34 (EMEA/V/A/088).
English: In a GCP-compliant randomised, blinded and negatively controlled challenge study, chickens were treated with powder for use in drinking water containing a combination of lincomycin and spectinomycin against induced E. coli, M. gallisepticum and combined E. coli plus M. gallisepticum infection.
Maltese: Fi studju ta' esponiment randomizzat, blinded u kkontrollat b'mod negattiv, konformi ma' PKT, it-tiġieġ kienu ttrattati bi trab għall-użu fl-ilma tax-xorb li kien fih kombinazzjoni ta' lincomycin u spectinomycin kontra infezzjoni indotta bl-E. coli, M. gallisepticum u infezzjoni kombinata bl-E. coli flimkien mal-M. gallisepticum.
English: Nonetheless, there are indications (from laboratory clinical studies) of clinical efficacy against E. coli located in and acquired via the respiratory tract, and against mycoplasmas, which are intracellular infections.
Maltese: Madankollu, hemm indikazzjonijiet (minn studji kliniċi fillaboratorju) ta' effikaċja klinika kontra E. coli ġewwa u akkwiżita permezz tal-apparat respiratorju, u kontra l-mikoplażmi, li huma infezzjonijiet intraċellulari.
English: Also, pharmacovigilance data do not indicate a risk of MRL violation.
Maltese: Barra minn hekk, id-data ta' farmakoviġilanza ma tindikax riskju ta' ksur tal-MRL.
English: In E. coli the MIC distribution appears to be bimodal, with a significant number of strains showing high MIC values; this could partly correspond to natural (intrinsic) resistance.
Maltese: Fl-E. coli, id-distribuzzjoni tal-MIC tidher li hija bimodali, b'numru sinifikanti ta' razez li juru valuri għolin ta' MIC; dan jista' jikkorrispondi parzjalment għal reżistenza naturali (intrinsika).
English: In chickens, powders for use in drinking water containing a combination of lincomycin and spectinomycin at a dose of 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw (50 mg combined actives/kg bw) per day for 7 days is considered effective in cases of CRD caused by M. gallisepticum and E. coli, and associated with a low mortality rate.
Maltese: Fit-tiġieġ, it-trab għall-użu fl-ilma tax-xorb, li fih kombinazzjoni ta' lincomycin u spectinomycin f'doża ta' 16.65 mg lincomycin u 33.35 mg spectinomycin/kg tal-piż tal-ġisem (50 mg ta' sustanzi attivi kombinati/kg tal-piż tal-ġisem) kuljum għal 7 ijiem, huwa meqjus bħala effettiv f'każijiet ta' CRD ikkawżat mill-M. gallisepticum u l-E. coli, u assoċjat ma' rata ta' mortalità baxxa.
English: Concerning powders for use in drinking water containing a combination of lincomycin and spectinomycin to be administered orally to pigs at a dose of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw (10 mg combined actives/kg bw) per day for 7 days is considered effective in cases of porcine proliferative enteropathy caused by L. intracellularis, and possible associated pathogens among which is E. coli.
Maltese: Rigward it-trab għall-użu fl-ilma tax-xorb, li fih kombinazzjoni ta' lincomycin u spectinomycin għallgħoti b'mod orali lill-ħnieżer f'doża ta' 3.33 mg lincomycin u 6.67 mg spectinomycin/kg tal-piż talġisem (10 mg ta' sustanzi attivi kombinati/kg tal-piż tal-ġisem) kuljum għal 7 ijiem, huwa meqjus bħala effettiv f'każijiet ta' enteropatija proliferattiva tal-ħnieżer kkawżata minn L. intracellularis, u patoġeni assoċjati possibbli fosthom l-E. coli.
English: List of the names, pharmaceutical forms, 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: For the treatment and metaphylaxis of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum and Escherichia coli susceptible to lincomycin and spectinomycin, and associated with a low mortality rate.
Maltese: Għat-trattament u l-metafilassi ta‘ mard respiratorju kroniku (CRD) ikkaġunat minn Mycoplasma gallisepticum u Escherichia coli suxxettibbli għal-lincomycin u lispectinomycin, u assoċjat ma‘ rata ta‘ mortalità baxxa.
English: It is possible that the substances are synergistic, act at different locations (intra- and extracellularly), or act by influencing the concurrent gut flora conditions.
Maltese: Huwa possibbli li s-sustanzi huma sinerġistiċi, jaġixxu f'postijiet differenti (b'mod intra- u extraċellulari), jew jaġixxu billi jinfluwenzaw il-kundizzjonijiet konkorrenti tal-flora fl-imsaren.
English: Piglets, chickens
Maltese: Qżieqeż, tiġieġ
English: SPC warnings informing the user about that resistance status are not considered sufficient to mitigate that risk, notably because of the absence of interpretive criteria and standardised methods for susceptibility testing.
Maltese: It-twissijiet fl-SPC li jinfurmaw lill-utent dwar dak l-istatus ta' reżistenza mhumiex meqjusa bħala suffiċjenti sabiex inaqqsu dak ir-riskju, b'mod partikolari minħabba n-nuqqas ta' kriterji interpretattivi u metodi standardizzati għall-ittestjar tas-suxxettibbiltà.
English: Extensive data are available in relation to the treatment of swine dysentery caused by Brachyspira hyodysenteriae and associated enteric pathogens, and for the treatment of porcine proliferative enteropathy caused by Lawsonia intracellularis.
Maltese: Hija disponibbli data estensiva dwar it-trattament tad-diżinterija tal-ħnieżer ikkawżata minn Brachyspira hyodysenteriae u patoġeni enteriċi assoċjati, u għat-trattament ta' enteropatija proliferattiva tal-ħnieżer ikkawżata minn Lawsonia intracellularis.
English: Based primarily on the latter experimental study, it is considered that the indication relating to chicken chronic respiratory disease (CRD) caused by M. gallisepticum and E. coli and associated with a low mortality rate, and the associated dosing regimen of 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw (50 mg combined actives/kg bw) per day for 7 days, as approved during the Article 34 referral procedure (EMEA/V/A/088) for Linco-Spectin 100, are justified as the only validated indication and dosage in chickens.
Maltese: Abbażi prinċipalment tal-aħħar studju sperimentali, huwa meqjus li l-indikazzjoni fir-rigward ta' mard respiratorju kroniku (CRD) fit-tiġieġ, ikkawżat mill-M. gallisepticum u l-E. coli u assoċjat ma' rata baxxa ta' mortalità, u l-iskeda ta' dożaġġ assoċjata ta' 16.65 mg lincomycin u 33.35 mg spectinomycin/kg tal-piż tal-ġisem (50 mg ta' sustanzi attivi kombinati/kg tal-piż tal-ġisem) kuljum għal 7 ijiem, kif approvata waqt il-proċedura ta' riferiment skont l-Artikolu 34 (EMEA/V/A/088) għal Linco-Spectin 100, huma ġustifikati bħala l-uniċi indikazzjoni u dożaġġ validati fit-tiġieġ.
English: For similar reasons, i.e. because of high in vitro resistance rates, in 2014, in the context of a referral procedure (EMEA/V/A/100)
Maltese: Għal raġunijiet simili, jiġifieri minħabba r-rati għoljin ta' reżistenza in vitro, fl-2014, fil-kuntest ta' proċedura ta' riferiment (EMEA/V/A/100)
English: The residue data presented for powders for use in drinking water do not call into question the withdrawal periods approved for each product individually at the dose of 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw/day, for 7 days.
Maltese: Id-data dwar ir-residwi ppreżentata għat-trab għall-użu fl-ilma tax-xorb ma tqajjimx dubji dwar ilperjodi ta' tiżmim approvati għal kull prodott individwalment fid-doża ta' 16.65 mg lincomycin u 33.35 mg spectinomycin/kg tal-piż tal-ġisem/jum, għal 7 ijiem.
English: Luxembourg Zoetis Belgium SA Rue Laid Burniat, 1
Maltese: Is-Slovenja Zoetis Belgium SA Rue Laid Burniat, 1
English: Belgium Zoetis Belgium SA Rue Laid Burniat, 1
Maltese: Il-Bulgarija Zoetis Belgium SA Rue Laid Burniat, 1
English: Calves, piglets, chickens
Maltese: Ħnieżer, tiġieġ, dundjani
English: The macrolide tylosin is closely related to lincosamides and binds to an overlapping ribosomal site.
Maltese: Il-makrolide tylosin huwa relatat mill-qrib mal-linkosamidi u jeħel ma' sit ribosomali mrikkeb.
English: Although doses are only expressed as levels in water, it can be estimated that the optimal doses range from 75 to 300 mg combined actives/kg bw.
Maltese: Għalkemm id-dożi huma espressi biss bħala livelli fl-ilma, jista' jiġi stmat li d-dożi ottimali jvarjaw minn 75 sa 300 mg ta' sustanzi attivi kombinati/kg tal-piż tal-ġisem.
English: A likely explanation to the mechanism of action of spectinomycin against respiratory E. coli is rather an indirect effect on the gut flora, leading to a reduction of the shedding into the environment.
Maltese: Spjegazzjoni probabbli għall-mekkaniżmu ta' azzjoni talispectinomycin kontra l-E. coli respiratorja hija pjuttost effett indirett fuq il-flora tal-imsaren, li jwassal għal tnaqqis fit-tifrix fl-ambjent.
English: The administration of the lincomycin and spectinomycin combination with the animal feed is currently recommended at relatively low doses and for prolonged periods (approximately 1 to 2.5 mg combined actives per kg bw (which is between 10% and 25% of the daily dose for powders for use in drinking water) for a relatively long period of 21 days).
Maltese: L-għoti tal-kombinazzjoni ta' lincomycin u spectinomycin mal-għalf tal-annimali filpreżent huwa rakkomandat f'dożi relattivament baxxi u għal perjodi fit-tul (madwar 1 sa 2.5 ta' sustanzi attivi kombinati għal kull kg tal-piż tal-ġisem (li huwa bejn 10% u 25% tad-doża ta' kuljum għat-trab għall-użu fl-ilma tax-xorb) għal perjodu relattivament twil ta' 21 jum).
English: The available in vitro susceptibility data indicate that spectinomycin and lincomycin can act synergistically in avian mycoplasmas such as M. gallisepticum.
Maltese: Id-data disponibbli dwar is-suxxettibbiltà in vitro tindika li spectinomycin u lincomycin jistgħu jaġixxu b'mod sinerġistiku f'mikoplażmi tat-tjur bħall-M. gallisepticum.
English: From the data provided, it appears that within the lincomycin-spectinomycin combination only lincomycin is active against the primary causal agent of swine dysentery, the anaerobic spirochete B. hyodysenteriae, which is intrinsically resistant to spectinomycin.
Maltese: Mid-data pprovduta, jidher li fi ħdan il-kombinazzjoni lincomycin-spectinomycin, lincomycin biss huwa attiv kontra l-aġent kawżattiv primarju tad-diżinterija tal-ħnieżer, l-ispiroċet anerobiku B.
English: In E. coli, a significant part of the strains show high MIC values (minimum inhibitory concentrations) against the lincomycin-spectinomycin combination and may be clinically resistant, although no breakpoint is defined.
Maltese: Fl-E. coli, parti sinifikanti mir-razez juru valuri għoljin ta' MIC (konċentrazzjonijiet minimi inibitorji) kontra l-kombinazzjoni lincomycin-spectinomycin u jistgħu jkunu klinikament reżistenti, għalkemm ma ġie definit l-ebda valur kritiku.
English: The residue data presented for powders for use in drinking water do not call into question the withdrawal periods approved for each product individually at the dose of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day, for 7 days.
Maltese: Id-data dwar ir-residwi ppreżentata għat-trab għall-użu fl-ilma tax-xorb ma tqajjimx dubji dwar ilperjodi ta' tiżmim approvati għal kull prodott individwalment fid-doża ta' 3.33 mg lincomycin u 6.67 mg spectinomycin/kg tal-piż tal-ġisem/jum, għal 7 ijiem.
English: The available clinical data show that the combination, administered in the drinking water at a dose of 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day for 7 days (i.e. the harmonised dose for Linco-Spectin 100), is clinically effective in treating mixed infections involving B. hyodysenteriae and other enteric pathogens targeted by spectinomycin, and that in those situations it is superior to the individual substances.
Maltese: It-tagħrif kliniku disponibbli juri li l-kombinazzjoni, mogħtija fl-ilma tax-xorb b'doża ta' 3.33 mg lincomycin u 6.67 mg spectinomycin/kg tal-piż tal-ġisem/jum għal 7 ijiem (jiġifieri d-doża armonizzata għal Linco-Spectin 100), hija klinikament effettiva fit-trattament ta' infezzjonijiet imħallta li jinvolvu lB. hyodysenteriae u patoġeni enteriċi oħra mmirati mill-ispectinomycin, u li f'dawk is-sitwazzjonijiet hija superjuri għas-sustanzi individwali.
English: Pigs, poultry
Maltese: Ħnieżer, tjur
English: Therefore, although overall the combination of lincomycin and spectinomycin showed to be clinically effective against E. coli in chickens, appropriate sentence should be included in SPC section 5.1 Pharmacodynamic properties to reflect the lack of absorption of spectinomycin in the gut.
Maltese: Għalhekk, għalkemm b'mod ġenerali l-kombinazzjoni ta' lincomycin u spectinomycin intweriet li hija klinikament effettiva kontra l-E. coli fit-tiġieġ, għandha tiġi inkluża sentenza xierqa fis-sezzjoni 5.1 tal-SPC “Kwalitajiet farmakodinamiċi” sabiex tirrifletti n-nuqqas ta' assorbiment tal-ispectinomycin fl-imsaren.
English: Data from a pilot challenge study suggest efficacy in case of proliferative enteropathy associated with a colibacillosis outbreak, although the study was not formally designed to investigate efficacy against E. coli.
Maltese: Data minn studju pilota tissuġġerixxi l-effikaċja f'każ ta' enteropatija proliferattiva assoċjata ma' tifqigħa ta' kolibaċillożi, għalkemm l-istudju ma kienx formalment iddisinjat sabiex jinvestiga l-effikaċja kontra l-E. coli.
English: From the available information it appears that the resistance rates in the target bacteria are relatively low, and there is no indication of an evolving status.
Maltese: Millinformazzjoni disponibbli jidher li r-rati ta' reżistenza fil-batterji fil-mira huma relattivament baxxi, u ma hemm l-ebda indikazzjoni ta' status ta' evoluzzjoni.
English: TARGET SPECIES
Maltese: Rotta talamministrazzjoni
English: Overall summary of the scientific evaluation of veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika tal-prodotti mediċinali veterinarji li fihom kombinazzjoni ta' lincomycin u spectinomycin għall-għoti b'mod orali lill-ħnieżer u/jew littjur (ara l-Anness I)
English: Spectinomycin is an aminocyclitol antibiotic derived from Streptomyces spectabilis, it has bacteriostatic activity and is active against Mycoplasma spp.
Maltese: Spectinomycin huwa antibijotiku aminocyclitol derivat minn Streptomyces spectabilis, għandu attività batterjostatika u huwa attiv kontra Mycoplasma spp. u kontra xi batterji gram-negattivi bħall-E. coli.
English: Overall there is no significant evidence of a synergistic interaction in vitro between lincomycin and spectinomycin in B. hyodysenteriae, and most authors consider that the benefit of the combination with spectinomycin in the treatment of swine dysentery lies rather in the extension of the spectrum to a broader range of organisms, i.e. spectinomycin would act against concurrent pathogens or on enteric bacteria establishing conditions in the gut favourable to the development of swine dysentery.
Maltese: B'mod ġenerali ma hemm lebda evidenza sinifikanti ta' interazzjoni sinerġistika in vitro bejn lincomycin u spectinomycin fil-B. hyodysenteriae, u l-biċċa l-kbira tal-awturi jqisu li l-benefiċċju tal-kombinazzjoni ma' spectinomycin fittrattament tad-diżinterija tal-ħnieżer jinsab pjuttost fl-estensjoni tal-ispettru għal firxa aktar wiesgħa ta' organiżmi, jiġifieri spectinomycin jaġixxi kontra patoġeni preżenti fl-istess ħin jew fuq batterji enteriċi li jistabbilixxu kundizzjonijiet fl-imsaren favorevoli għall-iżvilupp tad-diżinterija tal-ħnieżer.
English: Therefore, when considering the high in vitro resistance rate in B. hyodysenteriae, and to a lesser extent in possible associated pathogens, together with the limitations of the available clinical data, it appears that in the current situation the combination may remain effective only in a minority of field situations, and no well-established interpretive criterion or standardised test method exists which allows the user to predict efficacy against B. hyodysenteriae.
Maltese: Hyodysenteriae, u f'livell anqas f'patoġeni assoċjati possibbli, flimkien mal-limitazzjonijiet tat-tagħrif kliniku disponibbli, jidher li fissitwazzjoni preżenti l-kombinazzjoni tista' tibqa' effettiva biss f'numru żgħir ta' sitwazzjonijiet fil-kamp, u ma jeżisti l-ebda kriterju interpretattiv stabbilit sewwa jew metodu ta' ttestjar standardizzat li jippermetti lill-utent ibassar l-effikaċja kontra l-B. hyodysenteriae.
English: # median (min-max)
Maltese: # medjan (min-max)
English: • The active substance is defibrotide.
Maltese: • Is-sustanza attiva hi defibrotide.
English: Cmax (µg/mL) tmax (h)# AUCt (µg/mL*h) AUC (µg/mL*h) Vd (mL) CL (L/h) Kel (1/h) t1/2 (h)
Maltese: AUCt (µg/mL*h) AUC (µg/mL*h) Vd (mL) CL (L/h) Kel (1/h) t1/2 (h)
English: OTHER 200 mg/2.5 mL Gentium Srl
Maltese: OĦRAJN 200 mg/2.5 mL Gentium Srl
English: Measure 1
Maltese: Miżura 1
English: Preparation of Defitelio (use aseptic technique):
Maltese: Preparazzjoni ta' Defitelio (uża teknika asettika):