FrancophonIA/ELRC3.0 huggingface dataset:
English: Oral solution Pigs, Broilers
Maltese: Soluzzjoni orali Majjali, Brojlers
English: Due to the poor absorption in the gut colistin would only be effective against noninvasive Salmonella.
Maltese: Minħabba l-assorbiment limitat fl-imsaren colistin ikun effettiv biss kontra Salmonella mhux invażiva.
English: Domestic birds
Maltese: Majjali Tjur
English: Chicken: 75 000 IU colistin per kg per day (0,37 ml of Colivet per 10 kg twice a day) Pig: 50 000 IU of colistin per kg twice a day( 0,25 ml Colivet per 10 kg twice a day).
Maltese: Tiġieġ: 75 000 IU colistin kull kg kull jum (0,37 ml ta' Colivet kull 10 kg darbtejn kuljum) Majjal: 50 000 IU ta' colistin kull kg darbtejn kuljum( 0,25 ml Colivet kull 10 kg darbtejn kuljum).
English: daily or 0,25 ml/1 litre water
Maltese: I.U./kg /jum jew 0,25 ml/1 litru ilma
English: Pigs: 100000 UI /Kgbw Birds: 75000 UI/Kg bw
Maltese: Majjali: 100000 UI /Kgbw Għasafar: 75000 UI/Kg bw
English: Veterinary medicinal formulations containing colistin sulfate at 2 000 000 IU/ml and intended for administration via drinking water to calves, pigs, lambs and poultry are used for the treatment of infections of the gastrointestinal tract caused by Escherichia coli and Salmonella spp susceptible to colistin.
Maltese: Formulazzjonijiet mediċinali veterinarji li fihom colistin sulfate f'2 000 000 IU/ml u maħsuba għal amministrazzjoni permezz ta' ilma tax-xorb lil għoġġiela, majjali, ħrief u użati għat-trattament ta' infezzjonijiet tat-tratt gastrointestinali kkawżati minn Escheria coli u Salmonella spp li huma suxxettibbli għal colistin.
English: For some of the products concerned the recommended treatment interval was 3 to 5 days.
Maltese: Għal ftit mill-prodotti kkonċernati l-intervall ta' trattament irrakkomandat kien ta' 3 sa 5 jiem.
English: (2 times).
Maltese: 2 jiem.
English: (0,25 ml product/10 kg b.w.)
Maltese: (0,25 ml prodott/10 kg b.w.) (darbtejn).
English: Oral solution Pigs Poultry (broilers chickens)
Maltese: Soluzzjoni orali Majjali Tjur (brojlers tiġieġ)
English: Calves, Lambs, Porcine: 100 000 UI/kg/day Poultry: 75 000 UI/kg/day
Maltese: Għoġġiela, Ħrief, Majjali: 100 000 UI/kg/jum Tjur: 75 000 UI/kg/jum
English: Birds: 123000 UI /Kg bw /12 hours
Maltese: Għasafar: 123000 UI /Kg bw /12-il soegħa
English: Poultry: 0,03 ml/kg b.w/day Pigs: 0,5 ml/ 10 kg b.w.
Maltese: Tjur: 0,03 ml/kg b.w/jum Majjali: 0,5 ml/ 10 kg b.w. kull 12-il siegħa
English: Consequently, the use of colistin for the treatment of infections caused by Salmonella may interfere with specific control methods and national programmes for the control of Salmonella;
Maltese: Salmonella jista' jinterferixxi mal-metodi ta' kontroll speċifiċi u mal-programmi nazzjonali għall-kontroll tas-Salmonella;
English: The submitted residue depletion studies were reviewed and based on the recommended posology for cattle (100 000 IU colistin per kg body weight daily for 3-5 consecutive days) and the proposed harmonised posology for pigs and poultry (100 000 IU colistin per kg body weight daily for pigs and 75 000 IU colistin per kg body weight daily in poultry for 3-5 days) the withdrawal periods for calves, pigs and chickens were recalculated using the alternative method
Maltese: L-istudji ta' tnaqqis tal-fdal sottomessi ġew riveduti u bbażati fuq il-pożoloġija rrakkomandata għallfrat (100 000 IU colistin għal kull kg tal-piż tal-ġisem kuljum għal 3-5 jiem konsekuttivi) u l-pożoloġija armonizzata proposta għall-majjali u t-tjur (100 000 IU colistin għal kull kg tal-piż tal-ġisem kuljum għall-majjali u 75 000 IU colistin għal kull kg tal-piż tal-ġisem kuljum għat-tjur għal 3-5 jiem) ilperjodi ta' tiżmim għall-għoġġiela, majjali u tiġieġ ġew ikkalkolati mill-ġdid b'użu ta' metodu alternattiv
English: Chicken and egg-laying hens: 1 day
Maltese: Tiġieġ u egg tiġieġa tal-bajds: 1 jum
English: Edible tissues: 1 day
Maltese: Tiġieġ: 1 jum
English: Complete or partial lack of efficacy can result in persistence of zoonotic organisms in treated animals (and in the environment) and delay effective elimination of Salmonella due to treatment failure.
Maltese: In-nuqqas totali jew parzjali tal-effikaċja jista' jirriżulta f'persistenza ta' organiżmi zoonotiċi fl-annimali ttrattati (u fl-ambjent) u dewmien fleliminazzjoni effettiva ta' Salmonella minħabba l-falliment tat-trattament.
English: Pigs: meat and offals 1 day.
Maltese: Majjali: laħam u offal 1 jum.
English: Colivet 2 000 000 IU/ml, Konzentrat für eine orale Lösung für Schweine und Geflügel
Maltese: COLISCOUR 2 000 000 IU/ml, concentrate for oral solution, pigs, poultry
English: 100 000 IU colistin / kg body weight daily for 3-5 days.
Maltese: 100 000 IU colistin / kg piż talġisem kuljum għal 3-5 jiem.
English: Oral administration (drinking water) treatment: 3 days
Maltese: Amministrazzjoni orali (ilma tax-xorb) trattament: 3 jiem
English: By contrast, the CVMP considered that the absence of any data or argumentation from the Applicants/Marketing Authorisation Holders in support of a claim “…for treatment of gastrointestinal infections caused by Salmonella spp…” may constitute a risk to public and animal health as treatment might make the bacteria difficult to detect without completely eliminating the infection/colonisation.
Maltese: B'kuntrast għal dan, is-CVMP ikkunsidra li n-nuqqas ta' dejta jew argumentazzjoni millApplikanti/Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq b'appoġġ għal pretensjoni “... għattrattament ta' infezzjonijiet gastrointestinali kkawżati minn Salmonella spp...” jista' jikkostitwixxi riskju għas-saħħa pubblika u tal-annimali minħabba li t-trattament jista' jagħmel lill-batteri diffiċli biex jinstabu mingħajr ma jelimina l-infezzjoni/kolonizzazzjoni.
English: Consequently the benefit-risk balance for colistin was considered negative for treatment of gastrointestinal infections cased by Salmonella spp in calves, lambs, pigs and poultry.
Maltese: infezzjonijiet gastrointestinali kkawżati minn Salmonella spp fl-għoġġiela, ħrief, majjali u tjur.
English: The procedure involved 47 veterinary medicinal products authorised or pending authorisation in different Member States of the European Union (see Annex I).
Maltese: Il-proċedura involviet 47 prodott mediċinali veterinarju awtorizzat jew li qed jistenna l-awtorizzazzjoni fi Stati Membri differenti fl-Unjoni Ewropea (ara Anness I).
English: Meat and offal: 7 day
Maltese: Laħam u offal: 7 jiem
English: Broilers and layers: 1 day
Maltese: Brojlers u bajjada: 1 jum
English: Eggs: 1 day.
Maltese: Bajd: 1 jum.
English: S.C. CRIDA PHARM S.R.L.
Maltese: Ir-Rumanija S.C. CRIDA PHARM
English: Calves, Lamb: 50.000 I.U./kg b.w.
Maltese: Għoġol, Majjal: 50 000 IU/kg bw
English: Delete, where applicable, treatment of gastrointestinal infections other than E. coli.
Maltese: Ħassar, fejn applikabbli, trattament ta' infezzjonijiet gastrointestinali li mhumiex minn E. coli.
English: Swine: 100 000 UI/kg BW/day Birds: 75 000 UI/kg BW/day
Maltese: Majjali: 100 000 UI/kg BW/jum Għasafar: 75 000 UI/kg BW/jum
English: Meat: 9 days
Maltese: Laħam: 9 jiem
English: For 3-5 days
Maltese: trattament: 3 - 5 jiem
English: With regard to treatment of Salmonella spp.
Maltese: Fir-rigward ta' trattament ta' infezzjonijiet b'Salmonella spp.
English: Calves: 2 days Lamb: 7 days
Maltese: Għoġġiela: 2 jiem Ħaruf: 7 jiem
English: Oral administration (drinking water or as milk replacer) treatment: 4-5 days
Maltese: Amministrazzjoni orali (ilma tax-xorb jew bħala sostitut tal-ħalib) trattament: 4-5 jiem
English: Oral administration (drinking water) treatment: 3 consecutive days
Maltese: Amministrazzjoni orali (ilma tax-xorb) trattament: 3 jiem konsekuttivi
English: colistin /1 kg b.w./day for 3 - 5 days, (0,37 ml of product /10 kg b.w.twice daily for 3 - 5 days Pigs: 50000 I.U colistin /1 kg b.w./day for 3 - 5 days, (0,25 ml of product/10 kg b.w.
Maltese: 75000 I.U. colistin /1 kg b.w./jum għal 3 - 5 jiem, (0,37 ml ta' prodott /10 kg b.w.darbtejn kuljum għal 3 - 5 jiem
English: In summary the CVMP considered that there was sufficient information to support the treatment of gastrointestinal infections caused by non-invasive E. coli susceptible to colistin, when administered at dose of 100 000 IU colistin per kg body weight daily for calves, lambs, pigs and 75 000 IU colistin per kg body weight daily in poultry for 3-5 consecutive days.
Maltese: Fil-qosor, is-CVMP ikkunsidra li ma kienx hemm informazzjoni biżżejjed biex tappoġġja t-trattament ta' infezzjonijiet gastrointestinali kkawżati minn E. coli mhux invażiv suxxettibbli għal colistin, meta amministrata b'doża ta' 100 000 IU colistin għal kull kg ta' piż tal-ġisem għal għoġġiela, ħrief, majjali u 75 000 IU colistin għal kull kg tal-piż tal-ġisem fi tjur għal 3-5 jiem konsekuttivi.
English: • the CVMP considered that colistin administered orally has been used to treat gastrointestinal infections caused by non-invasive E. coli infections in calves, lambs, pigs and poultry during decades.
Maltese: • Is-CVMP ikkunsidra li colistin amministrat b'mod orali ilu jintuża għat-trattament ta' infezzjonijiet gastrointestinali kkawżati minn E. coli mhux invażiv fl-għoġġiela, ħrief, majjali u tjur għal deċenni.
English: The submitted data by the Applicants/Marketing Authorisation Holders showed that the concerned veterinary medicinal products are authorised or pending authorisations via different marketing authorisation procedures (mutual recognition procedures or national procedures) and under various legal bases (full and generic).
Maltese: Id-dejta sottomessa mill-Applikanti/Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq turi li l-prodotti mediċinali veterinarji huma awtorizzati jew qed jistennew l-awtorizzazzjoni permezz ta' proċeduri differenti ta' awtorizzazzjoni għat-tqegħid fis-suq (proċeduri ta' rikonoxximent komuni jew proċeduri nazzjonali) u taħt diversi bażijiet legali (sħaħ u ġeneriċi)
English: Meat and offals: 7 days.
Maltese: Laħam u offal: 7 jiem.
English: Chicken: 1 day Other poultry: 7 days.
Maltese: Tiġieġ: 1 jum Tajr ieħor: 7 jiem.
English: It was noted that the analysis, based on the determination of colistin sulfate concentration in the gastrointestinal tract after different levels of exposure and minimum inhibitory concentrations (MIC) data from E. coli strains collected in five European countries could be questioned as the surrogate endpoint Cmax/MIC was not validated for local exposure in the gastrointestinal tract and the fraction of active compound bound to the faecal content was not known.
Maltese: Kien innutat li l-analiżi, ibbażata fuq id-determinazzjoni tal-konċentrazzjoni ta' colistin suplphate fit-tratt gastrointestinali wara livelli differenti ta' esponiment u dejta dwar konċentrazzjonijiet inibitorji minimi (MIC) minn razez ta' E. coli miġbura minn ħames pajjiżi Ewropej setgħet tiġi ddubitata minħabba li l-punt ta' tmiem surrogat Cmax/MIC ma kienx validat għal esponiment lokali fit-tratt gastrointestinali u l-frazzjoni tal-kompost attiv fil-feċi ma kinetx magħrufa.
English: Germany Divasa-Farmavic S.A.
Maltese: Il-Polonja DIVASA - FARMAVIC, S.A.
English: Daily.Orally
Maltese: B'mod orali
English: 4.9 Amounts to be administered and administration route To be administered orally.
Maltese: .9 Doża rakkomandata u l-metodu ta' amministrazzjoni Għandha tingħata b'mod orali.
English: With regard to gastrointestinal infections caused by non-invasive E. coli in calves and lambs the data submitted to support the indication were limited.
Maltese: Fir-rigward ta' infezzjonijiet gastrointestinali kkawżati minn E. coli mhux invażiv f'għoġġiela u ħrief iddejta sottomessa biex tappoġġja l-indikazzjoni kienet limitata.
English: Treatment of gastrointestinal infections caused by non-invasive E. coli susceptible to colistin.
Maltese: Trattament ta' infezzjonijiet gastrointestinali kkawżati minn E. coli mhux invażiv suxxettibbli għal colistin.
English: With regard to the efficacy in chickens a study report from public literature was provided where E. coli infections were treated with colistin sulfate given in feed.
Maltese: Fir-rigward tal-effikaċja fit-tiġieġ, kien ipprovdut rapport studju minn litteratura pubblika fejn infezzjonijiet minn E. coli kienu ttrattati b'colistin sulfate mogħti mal-ikel.
English: 3 days
Maltese: 3 jiem
English: Pigs: meat: 1 day
Maltese: Tjur: laħam u bajd: 1 jum
English: Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product /1 tone bw/day for 3 consecutive days.
Maltese: Tjur: 75 000 IU ta' colistin / kg bw/jum, jiġifieri 37,5 ml ta' prodott /1 tone bw/jum għal tlett ijiem konsekuttivi.
English: Calves: 2 days.
Maltese: Majjali: 2 jiem
English: Two products had a recommended duration of treatment of 3-4 consecutive days.
Maltese: Żewġ prodotti kellhom tul irrakkomandat ta' 3-4 jiem konsekuttivi.
English: Calf, Pig: 0.25 ml product/10 kg bw twice daily for 3-4 days
Maltese: Għoġol, Majjal: 0.25 ml prodott/10 kg bw darbtejn kuljum għal 3-4 jiem
English: Meat: 7 days.
Maltese: Tjur:75.
English: Meat and offal: 1 day
Maltese: Laħam u offal: 1 jum
English: Furthermore, the Committee noted that treatment of subclinical Salmonella with the objective to reduce the number of bacteria might interfere with control programmes for this disease1.
Maltese: Barra minn hekk, ilKumitat innota li t-trattament ta' Salmonella subklinika bil-għan li jnaqqas in-numru ta' batteri, jista' jinterferixxi ma' programmi ta' kontroll tal-marda1.
English: Meat: 1 day.
Maltese: Laħam: 1 jum.
English: Recommended dose
Maltese: perjodi ta'
English: Pigs: 50 000 IU/kg of body weight, i.e. 0.25 ml Colivet Solution per 10 kg of body weight twice daily for 3-5 consecutive days.
Maltese: Majjali: 50 000 IU/kg ta' piż tal-ġisem, jiġifieri 0.25 ml Colivet Solution kull 10 kg ta' piż tal-ġisem darbtejn kuljum għal 3-5 jiem konsekuttivi.
English: However, oral colistin could be useful for treating non-invasive E. coli infection in these species and the effect of treatment is easily detected in clinical practice.
Maltese: Madankollu, colistin orali tista' tkun utli għat-trattament ta' infezzjoni minn E. coli mhux invażiv u l-effett tat-trattament jista' jiġi nnotat faċilment fil-prattika klinika.
English: of colistin sulfate /1kg b.w./day, i.e. 0,05 ml of product/ kg of body weight /day
Maltese: I.U. ta' colistin sulfate /1kg b.w./jum, jiġifieri 0,05 ml ta' prodott/ kg ta' piż tal-ġisem /jum
English: UI/kg b.w/ day equivalent to 0,5 ml/10 kg b.w./day Poultry: 100.000 UI/kg b.w./day equivalent to 0,5 ml/litre drinking water/day
Maltese: UI/kg b.w/ jum ekwivalenti għal 0,5 ml/10 kg b.w./jum
English: Meat: pigs: 7 days
Maltese: Laħam: majjali: 7 jiem
English: Calf: 3 days
Maltese: Għoġol: 3 jiem
English: IU/kg BW/day, for 3 days (equivalent to 0.06 ml of Colistop Solution /kg BW /day, for 3 consecutive days)
Maltese: Brojlers tiġieġ: 123,000 IU/kg BW/jum, għal 3 jiem (ekwivalenti għal 0.06 ml ta' Colistop Solution /kg BW /jum, għal tlett ijiem konsekuttivi)
English: Pigs: 100,000 IU/Kg BW x 3 days
Maltese: IU/Kg BW X 3 jiem
English: Oral solution Pigs Birds
Maltese: Soluzzjoni orali Majjali Tjur
English: It was noted that some parts of the data presented were identical but were submitted by different Applicants/Marketing Authorisation Holders.
Maltese: Ġie innotat li xi partijiet tad-dejta ppreżentata kienu identiċi iżda ġew sottomessi minn Applikanti/Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq differenti.
English: Oral administration (drinking water or milk replacer) treatment: 3 - 4 days
Maltese: Amministrazzjoni orali (ilma tax-xorb jew bħala sostitut tal-ħalib) trattament: 3 - 4 jiem
English: Consequently the benefit-risk balance for colistin was considered positive for treatment of gastrointestinal infections caused non-invasive E. coli infections in calves and lambs with the recommended dose of 100 000 IUper kg body weight daily.
Maltese: Konsegwentament, il-bilanċ ta' benefiċċju-riskju għal colistin kien ikkunsidrat pożittiv għat-trattament ta' infezzjonijiet gastrointestinali kkawżati minn infezzjonijiet minn E. coli flgħoġġiela u fil-ħrief bid-doża rrakkomandata ta' 100 000 IU għal kull kg ta' piż tal-ġisem kuljum.
English: Poultry: 100.000 I.U.
Maltese: Tjur: 100.
English: Eggs: 1 day
Maltese: Bajd: 1 jum
English: 3 - 5 days in drinking water, milk or direct administration
Maltese: 3 - 5 jiem fl-ilma taxxorb, ħalib jew amministrazzjoni diretta
English: 49500 Segré Cedex FRANCE
Maltese: Route d'Avire, BP 103 49500 Segré Cedex FRANCE
English: There was also sufficient documented evidence in support of efficacy of colistin sulfate when used in poultry for the treatment of gastrointestinal infections caused by non-invasive E. coli, susceptible to colistin, at a daily dose of 75 000 IU colistin per kg body weight daily for 3-5 consecutive days.
Maltese: Kien hemm ukoll evidenza dokumentata biżżejjed b'appoġġ għall-effikaċja ta' colistin sulfate meta użata fit-tiġieġ għat-trattament ta' infezzjonijiet gastrointestinali ikkawżati minn E. coli mhux invażiv, suxxettibbli għal colistin, b'doża ta' kuljum ta' 75 000 IU ta' colistin għal kull kg ta' piż tal-ġisem għal 3-5 jiem konsekuttivi.
English: Chickens: 75000 I.U.
Maltese: Tjur: 75000
English: DIVASAFARMAVIC, S.A. Ctra.
Maltese: Divasa-Farmavic S.A. Ctra San Hipolito km
English: Meat: 7 days
Maltese: Laħam: 7 jiem
English: Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product /10 kg bw/day for 3 consecutive days.
Maltese: Majjali: 100 000 IU ta' colistin / kg bw/jum, jiġifieri 0,50 ml ta' prodott /10 kg bw/jum għal tlett ijiem konsekuttivi.
English: every 12 hours
Maltese: 1 jum
English: Denmark Divasa-Farmavic S.A.
Maltese: Id-Danimarka Divasa-Farmavic S.A. Ctra San Hipolito km
English: In the submitted Periodic Safety Update Reports no lack of efficacy has been reported for the claimed indications in calves and lambs.
Maltese: Fir-Rapporti tal-Aġġornament Perjodiku dwar isSigurtà sottomessi ma ġie rrapportat ebda nuqqas ta' effikaċja għall-indikazzjonijiet misħuqa flgħoġġiela u fil-ħrief.
English: LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIOD AND APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Maltese: VETERINARJI, RAZEZ TAL-ANNIMALI, MOD TA' AMMINISTRAZZJONI, PERJODU TA' TIŻMIM
English: Pigs: Meat and offals: 1 day.
Maltese: Majjali: Laħam u offal: 1 jum.
English: Pig
Maltese: Str.
English: or 0,25 ml of product/ 10 kg b.w Poultry: 75.000 I.U./kg /day or 0,25 ml/1 litre water
Maltese: I.U./ kg b.w. Kuljum jew 0,25 ml/1 litru ilma
English: Pigs: Meat and offal: 1 day
Maltese: Majjali: Laħam u offal: 1 jum
English: Poultry: 75 000 IU of colistin per kg body weight per day for 3 consecutive days by oral route, i.e. 37.5 ml of product per tonne of body weight per day for 3 consecutive days.
Maltese: Tjur: 75 000 IU ta' colistin kull kg piż tal-ġisem kull jum għal tlett ijiem konsekuttivi b'mod orali, jiġifieri 37.5 ml ta' prodott kull tonne ta' piż talġisem kull jum għal tlett ijiem konsekuttivi.
English: Pig: 2 days
Maltese: Majjal: 2 jiem
English: With regard to the efficacy in pigs the pre-clinical data revealed that the selection of dose rate and dose interval for colistin sulfate in pigs was chosen by using a pharmacokinetic/pharmacodynamic (PK/PD) analysis.
Maltese: Fir-rigward tal-effikaċja fil-majjali, id-dejta pre-klinika wriet li l-għażla tar-rata tad-doża u l-intervall għad-doża għal colistin sulfate fil-majjali ntgħażlet permezz tal-użu ta'
English: Although the quality of the data provided was considered to be poor and in some cases lacking, and so failed to support some of the indications claimed, the Committee considered that there was sufficient documented evidence in support of efficacy of colistin sulfate when used in pigs for the treatment of gastrointestinal infections caused by non-invasive E. coli, susceptible to colistin, at dose of 100 000 IU colistin per kg body weight daily for 3-5 consecutive days.
Maltese: Għalkemm il-kwalità tad-dejta provduta kienet meqjusa fqira u f'ċerti każijiet nieqsa, u għalhekk naqset milli tappoġġja xi indikazzjonijiet misħuqa, il-Kumitat ikkunsidra li kien hemm evidenza dokumentata biżżejjed b'appoġġ għall-effikaċja ta' colistin sulfate meta wżata fil-majjali għattrattament ta' infezzjonijiet gastrointestinali kkawżati minn E. coli mhux invasiv, suxxettibbli għal colistin, b'doża ta' 100 000 IU ta' colistin għal kull kg ta' piż tal-ġisem għal 3-5 jiem konsekuttivi.
English: Pigs - 102,500 IU/kg BW every 12 hours, for 3 days (equivalent to 0.5 ml of Colistop Solution /10 kg BW every 12 hours, for 3 consecutive days).
Maltese: IU/kg BW kull 12-il siegħa, għal 3 jiem (ekwivalenti għal 0.5 ml ta' Colistop Solution /10 kg bw kull 12-il siegħa, għal tlett ijiem konsekuttivi).
English: Consequently the benefit-risk balance for colistin was considered positive for treatment of gastrointestinal infections caused by non-invasive E. coli in pigs and poultry when used with the posologies mentioned.
Maltese: Konsegwentament il-bilanċ ta' benefiċċju-riskju għal colistin kien ikkunsidrat pożittiv għat-trattament ta' infezzjonijiet gastrointestinali minn E. coli mhux invażiv fil-majjali u t-tjur meta użat mal-pożoloġiji msemmija.
English: Meat: 1 days
Maltese: Majjali: 1 jum
English: Broilers and laying hens: 1 day,
Maltese: Brojlers u tiġieġ tal-bajd: 1 jum,
English: Oral solution Cattle (suckling calf)
Maltese: Amministrazzjoni orali (ilma tax-xorb)
English: Calves and Pigs: 100.000
Maltese: Majjali: 50000
English: Calf, Pig: 50 000 IU/kg bw Broiler chicken, laying hen: 75 000 IU/kg bw/day.
Maltese: IU ta' colistin għal kull kg ta' piż tal-ġisem kuljum fl-għoġġiela, ħrief, majjali u 75 000 IU ta'
English: Broiler and laying, hens: 1 day.
Maltese: Majjali, Għoġġiela, tiġieġ: 1 jum
English: The United Kingdom expressed concerns that differences in the posology and withdrawal periods established across the European Union for veterinary medicinal formulations containing colistin at 2 000 000 IU/ml and intended for administration in drinking water to any food producing species may present a potential serious risk to public and animal health.
Maltese: Ir-Renju Unit esprima t-tħassib li differenzi fil-pożoloġija u l-perjodi ta' tiżmim stabbiliti madwar lUnjoni Ewropea għal formulazzjonijiet mediċinali veterinarji li fihom colistin b'2 000 000 IU/ml u maħsubin għal amministrazzjoni fl-ilma tax-xorb lil kwalunkwe speċi ta' produzzjoni tal-ikel jista' jippreżenta riskju potenzjali serju għas-saħħa pubblika u tal-annimali.
English: Broilers: 75 000 IU colistin per kg of bodyweight (i.e. 0.37 ml of product per 10 kg of bodyweight per day for 3-5 days via drinking water)
Maltese: Brojlers: 75 000 IU colistin kull kg ta' piż tal-ġisem (jiġifieri 0.37 ml ta' prodott kull 10 kg
English: Pigs: 50 000 IU colistin per kg of bodyweight per 12 hrs (i.e. 0.25 ml of product per 10 kg of bodyweight per 12 hrs for 35 days via drinking water or milk replacement).
Maltese: Majjali: 50 000 IU colistin kull kg ta' piż tal-ġisem kull 12-il siegħa (jiġifieri 0.25 ml ta' prodott kull 10 kg ta' piż talġisem kull 12-il siegħa għal 3-5 jiem permezz tal-ilma tax-xorb jew sostituzzjoni tal-ħalib).
English: First Data Lock Point (DLP) = 30 August 2013
Maltese: L-Ewwel Punt ta' Wasla tad-Dejta (DLP) = 30 ta' Awwissu 2013
English: • Shortening of PSUR cycle from 3 yearly to 6-monthly PSURs until 2016.
Maltese: • Tqassir taċ-ċiklu tal-PSUR minn PSURs kull 3 snin għal kull sitt xhur sal-2016.
English: Safety reports focused on cardiovascular adverse events, haemorrhagic adverse events and off-label use should be submitted together with the 6-monthly PSURs.
Maltese: Rapporti dwar is-sigurtà ffokati fuq avvenimenti kardjovaskulari avversi, avvenimenti emorraġiċi avversi u użu għal indikazzjoni mhux approvata għandhom jiġu sottomessi flimkien malPSURs ta' kull 6 xhur.
English: Annex IV Condition to the marketing authorisation
Maltese: Anness IV Kondizzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq
English: Deadline for submission of the Final study report: 30 June 2014.
Maltese: Id-data ta' skadenza għas-sottomissjoni tar-Rapport finali tal-istudju: 30 ta' Ġunju 2014.