FrancophonIA/ELRC3.0 huggingface dataset:
English: As ciprofloxacin represents only 2% of the total outcome of the enrofloxacin metabolism in chickens it is assumed that any potential risk of metabolites is encompassed by using the total residue approach assuming that the total dose is excreted as parent compound or as metabolites with a toxicity that is similar to the parent compound.
Maltese: Minħabba li ciprofloxacin jirrappreżenta biss 2% tar-riżultat totali tal-metaboliżmu ta' enrofloxacin fit-tiġieġ, huwa maħsub li kwalunkwe riskju potenzjali tal-prodotti metaboliċi huwa inkluż bl-użu ta' approċċ ta' reżidwu totali meta wieħed jassumi li d-doża totali hija eliminata bħala sustanza ewlenija jew bħala prodotti metaboliċi b'tossiċità li hija simili għas-sustanza ewlenija.
English: The study by Robinson et al 2005 is, overall, a well reported scientific paper, which has been published in a well established international peer reviewed Journal.
Maltese: L-istudju minn Robinson et al 2005 huwa, b'mod ġenerali, artiklu xjentifiku rrapportat sewwa, li ġie ippubblikat f'Ġurnal internazzjonali stabbilit sewwa rrevedut minn pari.
English: 2.1.3 Soil degradation
Maltese: 2.1.3 Degradazzjoni tal-ħamrija
English: Antibiotics are likely to be toxic to algae and cyanobacteria.
Maltese: L-antibijotiċi x'aktarx ikunu tossiċi għall-alki u cyanobacteria.
English: The Phase I environmental risk assessment following the VICH guideline results in Predicted Environmental Concentrations (PECs) in soil for Enro-K 10% Oral Solution for broiler chickens (10 mg/kg bw/day, for 5 days) above 100 µg/kg, thus requiring a Phase II assessment.
Maltese: Il-valutazzjoni tar-riskji ambjentali ta' Fażi I li segwiet il-linja gwida VICH irriżultat f'Konċentrazzjoniet Ambjentali Imbassrin (Predicted Environmental Concentrations - PECs) filħamrija għal Enro-K 10% Soluzzjoni Orali għall-flieles brojler (10 mg/kg piż tal-ġisem kuljum, għal 5 ijiem) ta' aktar minn 100 µg/kg, b'hekk kienet meħtieġa valutazzjoni ta' Fażi
English: Using this PNEC value and the PECsw established above (0.019 µg/l) a risk quotient of less than 0.01 can be established for aquatic invertebrates.
Maltese: 019 µg/l) seta' jiġi stabbilit kwozjent ta' riskju ta' inqas minn 0.01 għall-invertebrati akkwatiċi.
English: A study taken from the open literature, Knapp et al (2005)4, indicated that exposure is very low.
Maltese: Studju meħud mil-letteratura miftuħa, Knapp et al (2005)4, indika li l-esponiment huwa baxx ħafna.
English: The applicant provided an environmental risk assessment for Enro-K 10% Oral Solution that followed in general the established guidelines and recommendations.
Maltese: L-applikant ipprovda valutazzjoni tar-riskji ambjentali għal Enro-K 10% Soluzzjoni Orali li segwiet b'mod ġenerali l-linji gwida u r-rakkomandazzjonijiet stabbiliti.
English: The EC50 based on the final exposure concentration can be estimated to be 4.9 µg/l when considering the EC50 of 49 µg/l based on the nominal start concentration (equal to 100% recovery) and an average recovery of 10% of the nominal concentration (mean of the range 0 to 20%).
Maltese: L-EC50 ibbażat fuq il-konċentrazzjoni ta' esponiment finali tista' tkun stmata li hija 4.9 µg/l meta jkun ikkunsidrat l-EC50 ta' 49 µg/l ibbażat fuq il-konċentrazzjoni nominali tal-bidu (ugwali għallirkupru ta' 100%) u rkupru medju ta' 10% tal-konċentrazzjoni nominali (medja tal-medda 0 sa 20%).
English: During the decentralised procedure concerns were raised that Enro-K 10% Oral Solution may present a potential serious risk to the environment regarding risk to blue-green algae and to terrestrial plants.
Maltese: Waqt il-proċedura deċentralizzata tqajjem tħassib li Enro-K 10% Soluzzjoni Orali jista' jippreżenta periklu potenzjali serju għall-ambjent rigward riskju għall-alki blu-ħodor u pjanti ta' l-art.
English: Risk characterisation is calculated from the risk quotient (RQ), which should be less than 1 in all taxonomic levels to consider that enrofloxacin does not represent a risk to the environment.
Maltese: Il-karatterizzazzjoni tar-riskju huwa kkalkulat mill-kwozjent tar-riskju (RQ), li għandu jkun inqas minn 1 fil-livelli tassonomiċi biex ikun ikkunsidrat li enrofloxacin ma jippreżentax riskju għallambjent.
English: 50 ml of product per 100 litres water or 10 mg of the active ingredient per kg bodyweight per day.
Maltese: 100mg/ml Tiġieġ u dundjani50 ml tal-prodott għal kull 100 litru ta' ilma jew 10 mg tas-sustanza attiva għal kull kg ta' piż tal-ġisem kuljum.
English: This is a major reason why the EU (EMEA/CVMP) has made the testing of cyanobacteria mandatory for all antibiotics.
Maltese: Din hija r-raġuni ewlenija għala l-UE (EMEA/CVMP) għamlet l-ittestjar ta' cyanobacteria obbligatorju għall-antibijotiċi kollha.
English: From this data it can be concluded that there would be no risk at environmental concentrations 10 times the PECsoil value established above (542.9 µg/kg).
Maltese: Minn din id-data jista' jiġi konkluż li ma jkun hemm l-ebda riskju f'konċentrazzjonijiet ambjentali 10 darbiet il-valur tal-PECħamrija stabbilit hawn fuq (542.9 µg/kg).
English: The proposed EC50 values are acceptable and can be used to derive a PNEC value of 1.24 mg/kg (1240 µg/kg).
Maltese: Il-valuri EC50 huma aċċettabbli u jistgħu jintużaw biex joħorġu valur PNEC ta' 1.24 mg/kg (1240 µg/kg).
English: The EC50 based on the initial exposure concentration can be estimated to be 51.45 µg/l when considering the EC50 of 49 µg/l based on the nominal start concentration (equal to 100% recovery) and an initial average recovery of 105% of the nominal concentration.
Maltese: L-EC50 ibbażata fuq il-konċentrazzjoni ta' esponiment tal-bidu tista' tkun stmata li hija 51.45 µg/l meta jiġi kkunsidrat l-EC50 ta' 49 µg/l ibbażat fuq il-konċentrazzjoni nominali tal-bidu (ugwali għallirkupru ta' 100%) u rkupru tal-bidu medju ta' 105% tal-konċentrazzjoni nominali.
English: The number and variation in the soil types are considered acceptable.
Maltese: In-numru u l-varjazzjoni fit-tipi ta' ħamrija mhuwiex ikkunsidrat aċċettabbli.
English: Using this PNEC value and the PECsw established above (0.019 µg/l) a risk quotient of less than 0.01 can be established for fish.
Maltese: Bl-użu ta' dan il-valur PNEC u l-PECsw stabbilit hawn fuq (0.019 µg/l), kwozjent ta' riskju ta' inqas minn 0.01 jista' jkun stabbilit għall-ħut.
English: If the geometric mean of DT50 values from the four soils is used, the PECsoil-plateau is 506 µg/kg.
Maltese: Jekk tintuża l-medja ġeometrika tal-valuri DT50 mill-erba' ħamrijiet, il-PECħamrija-plateau huwa 506 µg/kg.
English: 2.3.6 Earthworms
Maltese: 2.3.3 Ħut
English: Higher tier modelling has furthermore revealed a negligible risk for ground water contamination.
Maltese: Barra minn hekk, tier modelling ogħla żvela riskju negliġibbli għallkontaminazzjoni tal-ilma ta' taħt l-art.
English: The proposed NOEC values are acceptable and can be used to derive a PNEC value of 100 mg/kg (100,000 µg/kg).
Maltese: Il-valuri NOEC proposti huma aċċettabbli u jistgħu jintużaw biex joħorġu valur PNEC ta' 100 mg/kg (100,000 µg/kg).
English: 2.2.2 PECgroundwater (PECgw)
Maltese: 2.2.2 PECilma ta' taħt l-art (PECgw)
English: If a less conservative approach is taken, the geometric mean of the four DT50 values could be used, i.e. 121 days.
Maltese: Jekk jittieħed approċċ inqas konservattiv, tista' tintuża l-medja ġeometrika tal-erba' valuri DT50, jiġifieri 121 jum.
English: Germany Laboratorios Karizoo S.A. Mas Pujades
Maltese: TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA
English: 2.2 Calculation of PEC values
Maltese: 2.1. Studji tad-destin ambjentali
English: Using this PNEC value and the PECsoil established above (542.9 µg/kg) a risk quotient of 0.44 can be established for plants.
Maltese: Bl-użu ta' dan il-valur PNEC u l-PECħamrija stabbilit hawn fuq (542.9 µg/kg) jista' jkun stabbilit kwozjent tarriskju ta' 0.44 għall-pjanti.
English: 11-12 Pol. Ind. La Borda 08140 Caldes de Montbui SPAIN
Maltese: Universal Farma, S.L. Gran Vía Carlos III, 98 - 7ª 08028 Barċellona SPANJA
English: An earthworm reproduction test according to OECD guideline 222 was performed.
Maltese: Sar test ta' riproduzzjoni tal-ħanex skont il-linja gwida tal-OECD 222.
English: The resulting PECgw value is 0.057 µg/l, which is below the critical trigger value of 0.1 µg/l.
Maltese: Il-valur tal-PECgw li jirriżulta huwa 0.057 µg/l, li huwa taħt il-valur kritiku ta' attivazzjoni ta' 0.1 µg/l.
English: However, it is the view of the CVMP, that a margin of more than 800 between the estimated PECsw (0.019 µg/l) and the EC50 calculated on the basis of the data in the Robinson et al paper (15.9 µg/l) indicates a very low exposure to cyanobacteria as a result of the use of this product, and gives reassurance that the actual risk to cyanobacteria is acceptable.
Maltese: Madankollu, hija l-opinjoni tas-CVMP, li marġini ta' iktar minn 800 bejn il-PECsw stmata (0.019 µg/l) u l-EC50 ikkalkolata fuq il-bażi tad-data fl-artiklu ta' Robinson et al (15.
English: It can be concluded that enrofloxacin does not pose a risk to fresh water invertebrates, fish, soil microorganisms and soil invertebrates.
Maltese: Jista' jkun konkluż li enrofloxacin ma joħloq ebda risku għall-invertebrati tal-ilma ħelu, ħut, mikroorganiżmi tal-ħamrija u invertebrati tal-ħamrija.
English: Using this PNEC value and the PECsoil established above (542.9 µg/kg) the risk quotient can be concluded to be far below 1 for earthworms.
Maltese: Bl-użu ta' dan il-valur PNEC u l-PECħamrija stabbilit hawn fuq (542.9 µg/kg) jista' jiġi konkluż li lkwozjent tar-riskju għall-ħniex huwa ħafna inqas minn 1.
English: The growth rates are unlikely to have been exponential, and therefore the tests are likely to have been conducted under sub-optimal sensitivity.
Maltese: Ir-rati ta' żvilupp x'aktarx li ma kinux esponenzjali, u għaldaqstant it-testijiet x'aktarx saru taħt sensittività sottottima.
English: The CVMP is of the opinion that the provided information on toxicity to cyanobacteria is insufficient for a full risk characterisation, as the information found in the peer reviewed paper by Robinson et al 2005, does not allow for a full assessment of e.g. the validity of data and the exposure concentration.
Maltese: Is-CVMP huwa tal-opinjoni li l-informazzjoni pprovduta fuq it-tossiċità għal cyanobacteria mhijiex suffiċjenti għall-karatterizzazzjoni sħiħa tar-riskju, peress li l-informazzjoni misjuba fl-artiklu rrevedut minn pari ta' Robinson et al 2005 ma tagħtix lok għal valutazzjoni sħiħa ta', ngħidu aħna, il-validità tad-data u l-konċentrazzjoni tal-esponiment.
English: The CVMP agrees that the applicant has met all the requirements for the plant toxicity evaluation, i.e. new toxicity data and the use of the PECsoil-plateau based on new degradation studies.
Maltese: Is-CVMP jaqbel li l-applikant issodisfa r-rekwiżiti kollha għall-valutazzjoni tat-tossiċità tal-pjanti, jiġifieri data ġodda tat-tossiċità u l-użu tal-PECħamrija-plateau ibbażat fuq studji ġodda ta' degradazzjoni.
English: Chickens and turkeys
Maltese: Ir-Repubblika Ċeka
English: No further consideration is made to the data of the green algae as this was more than 50 times less sensitive to enrofloxacin.
Maltese: Ma hemm bżonn li ssir l-ebda kunsiderazzjoni oħra għad-data tal-alki ħodor minħabba li dawn kienu iktar minn 50 darba inqas sensittivi għal enrofloxacin.
English: From this data set, it is concluded that enrofloxacin, used according to the applicant's indications, does not pose a risk to fresh water invertebrates, fish, soil micro-organism, plants and soil invertebrates.
Maltese: Minn dan is-sett ta' data, ġie konkluż li enrofloxacin, użat skont l-indikazzjonijiet tal-applikant, ma joħloqx periklu għal invertebrati tal-ilma ħelu, ħut, mikro-organiżmi tal-ħamrija, pjanti u invertebrati tal-ħamrija.
English: The CVMP concluded that the provided information on toxicity to cyanobacteria is insufficient for a full risk characterisation, as the information found in the peer reviewed paper by Robinson et al 2005 does not allow for a full assessment of e.g. the validity of data and the exposure concentration.
Maltese: Is-CVMP ikkonkluda li l-informazzjoni ipprovduta fuq it-tossiċità ta' cyanobacteria mhijiex biżżejjed għall-karatterizzazzjoni sħiħa tar-riskju, minħabba li l-informazzjoni misjuba fl-artiklu rrevedut minn pari ta' Robinson et al 2005 ma tagħtix lok għal valutazzjoni sħiħa ta', pereżempju, il-validità tad-data u l-konċentrazzjoni tal-esponiment.
English: The NOEC for the tested loamy sand field soil was found to be 2.9 mg enrofloxacin per kg soil (dry mass).
Maltese: L-NOEC għall-ħamrija tal-għelieqi tar-ramel għanja fit-tafal u materjal midbiel li ġie ttestjat instab li kien 2.9 mg enrofloxacin għal kull kg ħamrija (massa xotta).
English: Laboratorios Karizoo S.A. Mas Pujades
Maltese: ANNESS III SOMMARJU TAL-KARATTERISTIĊI
English: 2.3.Effect studies and calculation of PNEC values
Maltese: 2.3.Studji ta' l-effett u kalkolu ta' valuri PNEC
English: Date of last renewal: 19/09/2008.
Maltese: Data tal-aħħar tiġdid: 19/09/2008.
English: Antiinfectious agents/ Antibiotics'
Maltese: Aġenti antiinfettivi/ Antibijotiċi
English: 29 route des Industries 37530 Pocé-sur-Cisse
Maltese: 29 route des Industries 37530 Pocé-sur-Cisse FRANZA
English: MRLs
Maltese: MRL
English: ATCvet code: QJ01FA94.
Maltese: QJ01FA94
English: Draxxin 100 mg/ml: FAREVA AMBOISE Zone Industrielle, 29 route des Industries 37530 Pocé-sur-Cisse FRANCE
Maltese: Draxxin 100 mg/ml: FAREVA AMBOISE Zone Industrielle, 29 route des Industries 37530
English: Monothioglycerol Propylene glycol Citric acid Hydrochloric acid Sodium hydroxide Water for injections
Maltese: Monothioglycerol Propylene glycol Citric acid Hydrochloric acid Sodium hydroxide Ilma għall-injezzjoni
English: Plasma protein binding was approximately 60-75%.
Maltese: L-ammont abbinat mal-proteini tal-plażma kien bejn wieħed u ieħor 60-75%.
English: It lowers the production of the pro-inflammatory mediators leukotriene B4 and CXCL-8 and induces the production of anti-inflammatory and pro-resolving lipid lipoxin A4.
Maltese: Tnaqqas il-produzzjoni tal-medjaturi leukotriene B4 u CXCL-8 li jwasslu għall-imfjammazzjoni u twassal għall-produzzjoni ta' anti-inflammatory u pro-resolving lipid lipoxin A4.
English: 1348 Louvain-la-Neuve BELGIUM
Maltese: 1348 Louvain-la-Neuve Il-BELĠJU
English: The active substance in Draxxin is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attivà f'Draxxin hija sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness tarRegolament tal-Kummissjoni (UE) Nru 37/2010:
English: Cattle: 22 days.
Maltese: Baqar: 22 ġurnata.
English: Pharmacotherapeutic group: Antibacterials for systemic use, macrolides.
Maltese: Antibatterjoloġiċi għal użu sistemiku, makrolidi.
English: Tulathromycin (2R, 3S, 4R, 5R, 8R, 10R,
Maltese: Tulathromycin (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-2-ethyl tetrahydroxy hexamethyl-11[[3,4,6-trideoxy-3(dimethylamino)-ß
English: Zoetis Manufacturing & Research Spain, S.L.
Maltese: Zoetis Manufacturing & Research Spain, S.L. Ctra. de Camprodon, s/n Finca La Riba
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali ittrattati li juru effett(i) mhux mixtieq(a)) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ittrattat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ittrattat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ittrattat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ittrattat, inklużi rapporti iżolati).
English: Vial sizes: 20 ml, 50 ml, 100 ml, 250 ml and 500 ml.
Maltese: Daqsijiet tal-kunjett: 20 ml, 50 ml, 100 ml, 250 ml, u 500 ml.
English: Manufacturers responsible for batch release: FAREVA AMBOISE
Maltese: Manifattur responsabbli għall-ħrug tal-lott: FAREVA AMBOISE Zone Industrielle,
English: In sheep, the pharmacokinetic profile of tulathromycin, when administered as a single intramuscular dose of 2.5 mg/kg bodyweight, achieved a maximum plasma concentration (Cmax) of 1.19 µg/ml in approximately 15 minutes (Tmax) post-dosing and had an elimination half-life (t1/2) of 69.7 hours.
Maltese: Fin-nagħaġ, il-profil farmakokinetiku ta' tulathromycin meta tiġi amministrata f'doża waħda ta' 2.5 mg/kg piż fil-muskolu, wassal għall-għola livell (Cmax) fil-plażma ta' 1.19 µg/ml wara bejn wieħed u ieħor 15-il minuta (Tmax) mid-doża u half life ta' eliminazzjoni (t1/2) ta' 69.7 siegħa.
English: Date of first authorisation: 11/11/2003.
Maltese: DATA DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 11/11/2003.
English: Cattle (meat and offal): 22 days.
Maltese: Baqar (laħam u interjuri): 22 ġurnata.
English: Vial sizes: 50, 100 and 250 ml.
Maltese: Daqsijiet tal-kunjett: 50, 100 u 250 ml.
English: Porcine 800 µg/kg 300 µg/kg
Maltese: 800 µg/kg 300 µg/kg
English: Muscle Skin and fat in natural proportions Liver
Maltese: Muskolu Ġilda u xaħam fi proporzjoni jiet naturali
English: Tulathromycin may cause sensitisation by skin contact.
Maltese: Tulathromycin tista' tikkawża sensittività tal-ġilda.
English: EU/2/03/041/001 (20 ml) EU/2/03/041/002 (50 ml) EU/2/03/041/003 (100 ml) EU/2/03/041/004 (250 ml) EU/2/03/041/005 (500 ml)
Maltese: EU/2/03/041/001 (20 ml) EU/2/03/041/002 (50 ml) EU/2/03/041/003 (100 ml) EU/2/03/041/004
English: Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus requiring systemic treatment.
Maltese: Trattament tal-istadji bikrin ta' pododermatite infettiva (foot rot) assoċjata ma' Dichelobacter nodosus virulenti li għandha bżonn trattament sistemiku.
English: or
Maltese: D
English: - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ittrattat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ittrattat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ittrattat, inklużi rapporti iżolati).
English: Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to tulathromycin.
Maltese: Trattament ta' keratokonġunktivite bovina infettiva (IBK) assoċjata ma' Moraxella bovis sensittiva għat-tulathromycin.
English: 4500 µg/kg 3000 µg/kg
Maltese: 300 µg/kg 200 µg/kg 4 500 µg/kg 3 000 µg/kg
English: Increased minimum inhibitory concentration (MIC) values have been found in some isolates of Histophilus somni and Actinobacillus pleuropneumoniae.
Maltese: Histophilus somni u Actinobacillus pleuropneumonia.
English: Tulathromycin also possesses in vitro activity against Moraxella bovis, the bacterial pathogen most commonly associated with infectious bovine keratoconjunctivitis (IBK).
Maltese: Tulathromycin għandha ukoll attività in vitro kontra Moraxella bovis il-mikrobu assoċjat l-aktar ma' keratokonġunktivite bovina infettiva (IBK).
English: 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight).
Maltese: 2.5 mg tulathromycin/kg piż (ekwivalenti għal 1 ml/40 kg piż).
English: Pigs (meat and offal): 13 days.
Maltese: Majjal (laħam u interjuri): 13-il ġurnata.
English: For treatment of cattle over 300 kg bodyweight, divide the dose so that no more than 7.5 ml are injected at one site.
Maltese: Għal trattament ta' baqar 'il fuq minn 300 kg, aqsam id-doża biex f'kull post tal-injezzjoni ma jingħatawx aktar minn 7.5 ml.
English: Ovine, caprine
Maltese: Nagħaġ, kaprini
English: Tulathromycin is a semi-synthetic macrolide antimicrobial agent, which originates from a fermentation product.
Maltese: Tulathromycin hija sustanza makrolida semi-sintetika għal kontra l-mikrobi, li toriġina minn prodott ta' fermentazzjoni.
English: Antibiotic treatment of benign foot rot is not considered appropriate.
Maltese: Mhuwiex xieraq li ssir kura bl- antibijotiċi ta' foot rot benin.
English: The maximum concentration (Cmax) in plasma was approximately 0.6 µg/ml; this was achieved approximately 30 minutes post-dosing (Tmax).
Maltese: L-għola livell (Cmax) fil-plażma kien bejn wieħed u ieħor ta' 0.6 μg/ml; dan intlaħaq bejn wieħed u ieħor 30 minuta wara li ingħatat id-doża (Tmax).
English: There is strong evidence of substantial accumulation of tulathromycin in neutrophils and alveolar macrophages.
Maltese: Hemm evidenza ċara li jkun hemm ħażna ta' tulathromycin fin-newtrofili u makrofaġi tal-alvejoli.
English: Draxxin 25 mg/ml solution for injection for pigs Tulathromycin
Maltese: VETERINARJU Draxxin 25 mg/ml soluzzjoni għal injezzjoni għal majjali tulathromycin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (20 ml / 50 ml / 100 ml / 250 ml)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun (20 ml / 50 ml / 100 ml / 250 ml)
English: In vitro activity against Dichelobacter nodosus (vir), the bacterial pathogen most commonly associated with infectious pododermatitis (foot rot) in sheep has been demonstrated.
Maltese: Dichelobacter nodosus (vir), il-mikrobu patoġeniku l-aktar assoċjat ma' pododermatite infettiva (foot rot) fin-nagħag.
English: Resistance to macrolides can develop by mutations in genes encoding ribosomal RNA (rRNA) or some ribosomal proteins; by enzymatic modification (methylation) of the 23S rRNA target site, generally giving rise to cross-resistance with lincosamides and group B streptogramins (MLSB resistance); by enzymatic inactivation; or by macrolide efflux.
Maltese: Ir-reżistenza għal makrolidi tista' tiżviluppa permezz ta' mutazzjonijiet fil-genes li jġorru l-kodiċi ta' ribosomal RNA (rRNA) jew ta' xi proteini tar-ribozoma; b'modifikazzjoni enżimatika tat-23S rRNA target site, li ġeneralment iwassal għal reżistenza inkroċjata mal-linkosamidi u streptogramini talgrupp B (reżistenza MLSB); bit-twaqqif fl-attività permezz tal-enżimi; jew bi ħruġ ta' makrolidi.
English: The maximum concentration (Cmax) in plasma was approximately 0.5 µg/ml; this was achieved approximately 30 minutes post-dosing (Tmax).
Maltese: L-għola livell (Cmax) fil-plażma kien bejn wieħed u ieħor ta' 0.5 μg/ml; dan intlaħaq bejn wieħed u ieħor 30 minuta wara li ngħatat id-doża (Tmax).
English: 5 mg/ml For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Ctra.
Maltese: OĦRA
English: EU/2/03/041/003 (100 ml) EU/2/03/041/004 (250 ml)
Maltese: EU/2/03/041/004 (250 ml)
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Baqar:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s))- common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali ittrattati li juru effett(i) mhux mixtieq(a)) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ittrattat)
English: These signs resolve within a few minutes.
Maltese: Dawn is-sinjali jitilqu wara ftit minuti.
English: EU/2/03/041/007 (100 ml) EU/2/03/041/008 (250 ml)
Maltese: EU/2/03/041/008 (250 ml)
English: Following intravenous dosing the volume of distribution at steady-state (Vss) was 31.7 l/kg.
Maltese: Il-volum ta' distribuzzjoni fi stat stabbli (Vss) iddeterminat wara amministrazzjoni fil-vina, kien ta' 31.7 l/kg.