FrancophonIA/ELRC3.0 huggingface dataset:
English: European Control programmes of Salmonella in poultry in Europe have been focused on Salmonella Enteritidis, Salmonella Typhimurium, Salmonella Hadar, Salmonella Virchow and Salmonella Infantis, as the five most frequent serovars in human salmonellosis (Regulation (EC) No 2160/20039).
Maltese: Programmi Ewropej għall-Kontroll ta' Salmonella fit-tjur fl-Ewropa ġew iffukati fuq Salmonella Enteritidis, Salmonella Typhimurium, Salmonella Hadar, Salmonella Virchow u Salmonella Infantis, bħala l-ħames serotipi l-aktar frekwenti fis-salmonellożi tal-bniedem (ir-Regolament (KE) Nru 2160/20039).
English: (sachet)
Maltese: (qartas)
English: MIC90 was 8 μg/ml or less.
Maltese: L-MIC90 kienet 8 μg/ml jew inqas.
English: Bottle (booklet) and bag (label)
Maltese: Flixkun (fuljett) u borża (tikketta)
English: apramycin sulfate and weight of 91 g of product.
Maltese: IU ta' apramycin sulfate u piż ta' 91 g tal-prodott.
English: The CVMP noted that throughout the product information of Girolan the active substance was expressed as ‘g of apramycin activity'.
Maltese: Is-CVMP innota li matul l-informazzjoni dwar il-prodott ta' Girolan, is-sustanza attiva ġiet espressa bħala “g ta' attività ta' apramiċina”.
English: Homburg
Maltese: Hampshire
English: The expiry date refers to the last day of that month.
Maltese: Waqt il-proċedura ta' referenza ma ġiet ipprovduta l-ebda data aċċellerata.
English: Block bottomed laminated paper bag closed by pressurized heat-sealing jaws.
Maltese: Borża tal-karti laminata tat-tip block bottomed, magħluqa permezz ta' heat-sealing jaws ippressurizzati.
English: Regarding the indication in Salmonella, recent data were provided indicating good susceptibility to apramycin for Salmonella spp., however the only data specific to Salmonella Gallinarum was from Nigeria (Agbaje et al., 20107) and Korea (Kang et al., 20108) and the epidemiological situation in Europe might be different.
Maltese: Fir-rigward tal-indikazzjoni f'Salmonella, ġiet ipprovduta data riċenti li indikat suxxetibbiltà tajba għallapramiċina għal Salmonella spp, madankollu l-unika data speċifika għal Salmonella Gallinarum kienet min-Niġerja (Agbaje et al., 20107) u mill-Korea (Kang et al., 20108) u s-sitwazzjoni epidemjoloġika flEwropa tista' tkun differenti.
English: 1 x 10
Maltese: Kull qartas fih 1 x 10
English: Chickens:
Maltese: Fniek:
English: Apramycin sulfate equivalent to 1000 g apramycin activity per bag.
Maltese: Apramycin sulfate ekwivalenti għal 1000 g ta' attività ta' apramycin f'kull borża.
English: The studies analysed the effect of apramycin dosages between 3.45 mg/kg bodyweight (bw)/day and 75 mg/kg bw/day, via drinking water, during 3, 5 or 7 consecutive days.
Maltese: L-istudji analizzaw l-effett ta' dożaġġi tal-apramiċina bejn 3.45 mg/kg piż tal-ġisem (bw)/jum u 75 mg/kg bw/jum, permezz ta' ilma tax-xorb, matul 3, 5 jew 7 ijiem konsekuttivi.
English: Data for 36 months was presented for 3 batches of finished product packaged in the final containers (bottles, bags and two different size sachets).
Maltese: Ġiet ippreżentata data għal 36 xahar għal 3 lottijiet tal-prodott finali ppakkjat fil-kontenituri finali (fliexken, boroż u żewġ qratas ta' daqs differenti).
English: Chickens have been authorised in Ireland, Italy, the Netherlands, Portugal, Spain and the UK.
Maltese: It-tiġieġ ġew awtorizzati fl-Irlanda, fl-Italja, fin-Netherlands, fil-Portugall, fi Spanja u fir-Renju Unit.
English: Even host-adapted serovars (as Salmonella Dublin) might cause disease in humans (Evangelopoulou et al., 20142; Singh, 20133) so the use of antimicrobials in food producing animals should consider the zoonotic role of Salmonella and the consequences for public health (EFSA and ECDC, 20164).
Maltese: Anki serotipi adattati għall-ospitant (bħal Salmonella Dublin) jistgħu jikkawżaw mard fil-bnedmin (Evangelopoulou et al., 20142; Singh, 20133) għalhekk l-użu tal-antimikrobiċi f'annimali għall-konsum għandu jikkunsidra r-rwol żoonotiku ta' Salmonella u l-konsegwenzi għas-saħħa pubblika (EFSA u ECDC, 20164).
English: Cardboard box (sachet)
Maltese: Kaxxa tal-kartun (qartas)
English: Calves: Meat and offal: 28 days.
Maltese: Għoġġiela: Laħam u ġewwieni tal-annimali: 28 jum.
English: Scientific Opinion on the assessment of listing and categorisation of animal diseases within the framework of the Animal Health Law (Regulation (EU) No 2016/429): Salmonella infection in poultry with serotypes of animal health relevance (S. Pullorum, S. Gallinarum and S. arizonae).
Maltese: Scientific Opinion on the assessment of listing and categorisation of animal diseases within the framework of the Animal Health Law (Regulation (EU) No 2016/429):
English: These data are consistent with the published literature.
Maltese: Din id-data hija konsistenti mal-letteratura ppubblikata.
English: Aminoglycosides are listed by WHO (2017)14 as critically important for the treatment of certain zoonotic infections in humans (such as Enterococcus infections).
Maltese: L-aminoglikosidi huma elenkati mill-WHO (2017)14 bħala ta' importanza kritika għall-kura ta' ċerti infezzjonijiet żoontiċi fil-bnedmin (bħal infezzjonijiet b'Enterococcus).
English: apramycin and weight of 91 g of product.
Maltese: ta' apramycin u piż ta' 91 g tal-prodott.
English: These data are consistent with the information available in published literature.
Maltese: Din id-data hija konsistenti mal-informazzjoni disponibbli fil-letteratura ppubblikata.
English: Pre-ruminant calves:
Maltese: Sustanzi mhux attivi:
English: The limited MIC data indicated a MIC90 for apramycin of 3.5 μg/ml for E. coli isolates of rabbit origin and a proportion of <20% resistant strains.
Maltese: Id-data limitata dwar l-MIC indikat MIC90 għall-apramiċina ta' 3.5 μg/ml għal iżolati ta' E. coli ta' oriġini mill-fniek u proporzjon ta' razez reżistenti ta' <20%.
English: On 24 June 2016 Spain submitted a referral notification in accordance with Article 34 of Directive 2001/82/EC to the European Medicines Agency (the Agency) for Girolan and its associated name Apralan.
Maltese: Fl-24 ta' Ġunju 2016, Spanja ppreżentat notifika ta' referenza skont l-Artikolu 34 tadDirettiva 2001/82/KE lill-Aġenzija Ewropea għall-Mediċini (l-Aġenzija) għal Girolan u l-isem assoċjat tiegħu Apralan.
English: Drinking systems should be clean and free of rust to avoid reduction of activity.
Maltese: Is-sistemi tax-xorb għandhom ikunu nodfa u mingħajr sadid biex jiġi evitat tnaqqis fl-attività.
English: Salmonella strains were considered generally susceptible to apramycin (MIC≤16 μg/ml) and <5% of Salmonella Dublin strains were shown to be resistant to apramycin.
Maltese: Ir-razez ta' Salmonella ġew ikkunsidrati bħala ġeneralment suxxettibbli għall-apramiċina (MIC≤16 μg/ml) u <5% tar-razez ta' Salmonella Dublin intwerew li kienu reżistenti għall-apramiċina.
English: A wild-type cut-off value of ≥32 μg/ml for E. coli of cattle origin has been proposed.
Maltese: Ġie propost valur ta' limitu tat-tip selvaġġ ta' ≥32 μg/ml għal E. coli ta' oriġini mill-ħnieżer.
English: 'Salmonella Serovars And Their Host Specificity.'
Maltese: 3 Vikash Singh. 2013. ‘Salmonella Serovars And Their Host Specificity.' J Vet Sci Anim
English: This is stated in the Regulation (EC) No 2160/20039 and based on the EFSA Opinion (2004)11.
Maltese: Dan huwa ddikjarat fir-Regolament (KE) Nru 2160/20039 u huwa bbażat fuq lOpinjoni tal-EFSA (2004)11.
English: Pigs (weaned piglets):
Maltese: Qżieqeż (qżieqeż żgħar miftuma):
English: Calves, pigs, chickens
Maltese: Qżieqeż, Broilers, Fniek
English: The provided clinical data demonstrated that Girolan was effective in the treatment of bacterial enteritis caused by E. coli when administered at 12,500 IU apramycin per kg bw (corresponding to 22.5 mg of product/kg bw), daily for 7 consecutive days.
Maltese: Id-data klinika pprovduta wriet li Girolan kien effettiv fil-kura ta' enterite batterika kkawżata minn E. coli meta ngħata b'12,500 IU apramiċina għal kull kg bw (li tikkorrispondi għal 22.5 mg ta' prodott/kg bw), kuljum għal 7 ijiem konsekuttivi.
English: Apramycin sulfate equivalent to 50 g apramycin activity per bottle.
Maltese: Apramycin sulfate ekwivalenti għal 50 g ta' attività ta' apramycin f'kull flixkun.
English: Aminoglycosides may cause neuromuscular blockade.
Maltese: L-aminoglycosides jistgħu jikkawżaw imblokk newromuskolari.
English: Salmonella is one of the most frequent microorganisms causing foodborne zoonoses outbreaks and cases in Europe in humans (EFSA and ECDC, 20164).
Maltese: Salmonella hija waħda mill-aktar mikroorganiżmi frekwenti li jikkawżaw tifqigħat taż-żoonożi fl-ikel u f'każijiet fl-Ewropa fil-bnedmin (EFSA u ECDC, 20164).
English: Vikash Singh.
Maltese: INN Qawwa
English: These were conducted in Greece, Italy and Jordan, and involved 27-29 days old broilers from commercial farms with natural E. coli infection.
Maltese: Dawn saru fil-Greċja, fl-Italja u fil-Ġordan, u involvew tiġieġ tas-simna li kellhom 27-29 jum minn irziezet kummerċjali b'infezzjoni naturali b'E. coli.
English: The total clinical score in the 40 mg apramycin/kg bw group improved more rapidly than the 20 mg apramycin/kg bw group which improved more rapidly than the 0 mg apramycin/kg bw group.
Maltese: Il-punteġġ kliniku totali fil-grupp ta' 40 mg apramiċina/kg bw tjieb b'rata aktar mgħaġġla mill-grupp ta' 20 mg apramiċina/kg bw li tjieb b'rata aktar mgħaġġla mill-grupp ta' 0 mg apramiċina/kg bw.
English: Lay:
Maltese: Baqar:
English: However, no storage conditions are provided for these stability studies and it is therefore not clear if they have been conducted at 25 °C/60% RH in accordance with the requirements of the ‘Guideline on stability testing of existing active substances and related finished products (EMEA/CVMP/846/99-Rev.1)'15.
Maltese: Madankollu, l-ebda kundizzjoni dwar kif għandu jinħażen mhi pprovduta għal dawn l-istudju dwar l-istabbiltà u għalhekk mhuwiex ċar jekk dawn sarux b'25 °C/60% RH f'konformità marrekwiżiti tal-”Guideline on stability testing of existing active substances and related finished products (Linja gwida dwar ittestjar tal-istabbilità u prodotti finali relatati (EMEA/CVMP/846/99-Rev.1)”15.
English: Pigs (weaned piglets)
Maltese: Ħnieżer (qżieqeż miftuma)
English: Therefore, the CVMP considered it justified to retain the indication for Salmonella Dublin for Girolan.
Maltese: Għalhekk, is-CVMP ikkunsidra li huwa ġġustifikat li tinżamm l-indikazzjoni għal Salmonella Dublin għal Girolan.
English: The objectives were to evaluate the efficacy of apramycin sulfate, administered in the drinking water for five consecutive days, at dose levels of 75, 150 and 225 mg/litre as treatment for these infections.
Maltese: L-objettivi kienu li tiġi evalwata l-effikaċja tas-sulfat tal-apramiċina, mogħti fl-ilma tax-xorb għal ħamest ijiem konsekuttivi, f'livelli tad-doża ta' 75, 150 u 225 mg/litru bħala kura għal dawn l-infezzjonijiet.
English: INDICATIONS
Maltese: KONTRAINDIKAZZJONIJIET
English: MIC90 of European isolates of E. coli for apramycin was demonstrated to be 16 μg/ml with a wild-type cut-off value of ≥32 μg/ml.
Maltese: L-MIC90 ta' iżolati Ewropej ta' E. coli għall-apramiċina intweriet li kienet 16 μg/ml b'valur ta' limitu tattip selvaġġ ta' ≥32 μg/ml.
English: Dose (mg product per kg bodyweight per day)
Maltese: Doża (mg ta' prodott għal kull kg ta' piż tal-ġisem kuljum)
English: These studies involved one to three days old calves experimentally challenged with either Salmonella Dublin or Salmonella typhimurium, the most frequent serovars of Salmonella spp.
Maltese: Dawn l-istudji involvew għoġġiela li kellhom jum sa tlett ijiem, li ġew sfidati b'mod esperimentali b'jew Salmonella Dublin jew Salmonella typhimurium, is-serotipi l-aktar frekwenti ta' Salmonella spp fi speċi bovini.
English: Excipients:
Maltese: Assorbiment:
English: Each bag contains 1,000 x 106 IU apramycin sulfate and weight of 1,812 g of product.
Maltese: Kull borża fiha 1,000 x 106 IU ta' apramycin sulfate u piż ta' 1,812 g tal-prodott.
English: The provided clinical data demonstrated that Girolan was effective in the treatment and metaphylaxis of bacterial enteritis caused by Escherichia coli when administered at 20,000 IU apramycin per kilogram of bodyweight (corresponding to 36 mg of product/kg bw), daily for 5 consecutive days.
Maltese: Id-data klinika pprovduta wriet li Girolan kien effettiv fil-kura u l-metafilassi ta' enterite batterika kkawżata minn Escherichia coli meta ngħata b'20,000 U apramiċina għal kull kilogramma tal-piż talġisem (li tikkorrispondi għal 36 mg ta' prodott/kg bw), kuljum għal 5 ijiem konsekuttivi.
English: This was not considered acceptable, as the active substance strength should be expressed in IU/g product, since the assay is determined by means of a microbiological method.
Maltese: Dan ma tqisx aċċettabbli, peress li l-qawwa tas-sustanza attiva għandha tiġi espressa f'IU/g ta' prodott, peress li l-assaġġ jiġi ddeterminat permezz ta' metodu mikrobijoloġiku.
English: In this sense, in a scientific opinion (2017) of EFSA13, Salmonella infection in poultry (Salmonella Pullorum, Salmonella Gallinarum and Salmonella arizonae) has been assessed according to the criteria of the Animal Health Law.
Maltese: F'dan is-sens, f'opinjoni xjentifika (2017) tal-EFSA13, infezzjoni b'Salmonella fit-tjur (Salmonella Pullorum, Salmonella Gallinarum u Salmonella arizonae) ġiet ivvalutata skont il-kriterji tal-Liġi dwar is-Saħħa tal-Annimali.
English: Each sachet contains 2 x 106 IU apramycin sulfate and weight of 3.6 g of product.
Maltese: Kull qartas fih 2 x 106 IU ta' apramycin sulfate u piż ta' 3.6 g tal prodott.
English: Treatment of bacterial enteritis caused by Escherichia coli and clinical outbreaks due to Salmonella enterica subsp.
Maltese: Trattament ta' enterite batterjali kkawżata minn Escherichia coli u mard kliniku li jinfirex malajr minħabba Salmonella enterica subsp. enterica serovar Dublin (Salmonella
English: Each sachet contains 2 x 106 IU apramycin and weight of 3.6 g of product.
Maltese: Kull qartas fih 2 x 106 IU ta' apramycin u piż ta' 3.6 g tal-prodott.
English: Some studies pointed out resistance percentages of 38% (MIC data) or even higher for disk diffusion (up to
Maltese: Xi studji indikaw perċentwali ta' reżistenza ta' 38% (data MIC) jew saħansitra ogħla għal diffużjoni tad-diska (sa 82.1%).
English: Each sachet contains 1 x 106 IU apramycin sulfate and weight of 1.8 g of product.
Maltese: Kull qartas fih 1 x 106 IU ta' apramycin sulfate u piż ta' 1.8 g tal prodott.
English: The daily administration of apramycin at a dose of 12,500 IU apramycin per kg bw (corresponding to 22.5 mg of product/kg bw), via drinking water, during seven days was shown to be an efficacious method to control the post-weaning colibacillosis in piglets.
Maltese: L-għoti ta' kuljum tal-apramiċina b'doża ta' 12,500 IU apramiċina għal kull kg bw (li tikkorrispondi għal 22.5 mg ta' prodott/kg bw), permezz ta' ilma tax-xorb, matul sebat ijiem intwera li huwa metodu effikaċi sabiex tiġi kkontrollata l-kolibaċillożi wara l-ftim fil-qżieqeż.
English: Administration route:
Maltese: Mekkaniżi ta' reżistenza:
English: Further data of clinical isolates from different European countries showed that resistance proportion of E. coli against apramycin is up to 12%.
Maltese: Data ulterjuri ta' iżolati kliniċi minn pajjiżi Ewropej differenti wriet li l-proporzjon ta' reżistenza ta' E. coli kontra l-apramiċina huwa sa 12%.
English: Administer 12,500 IU apramycin sulfate per kilogram of bodyweight (corresponding to 22.5 mg of product/kg bw), daily for 7 consecutive days.
Maltese: Agħti 12,500 IU ta' apramycin sulfate għal kull kilogramma ta' piż tal-ġisem (li jikkorrispondu għal 22.5 mg tal-prodott/kg ta' piż tal-ġisem), kuljum għal 7 ijiem konsekuttivi.
English: Administer 80,000 IU apramycin sulfate per kilogram of bodyweight (corresponding to 144 mg of product/kg bw), daily for 5 consecutive days.
Maltese: Agħti 80,000 IU ta' apramycin sulfate għal kull kilogramma ta' piż tal-ġisem (li jikkorrispondu għal 144 mg tal-prodott/kg ta' piż tal-ġisem), kuljum għal 5 ijiem konsekuttivi.
English: Apramycin is a broad-spectrum bactericidal aminoglycoside antibiotic whose action results from the binding to the 30S subunit of the ribosome, preventing protein synthesis and disrupting the membrane permeability of bacteria.
Maltese: Apramycin hu antibijotiku aminoglycoside batteriċida bi spettru wiesgħa, li l-azzjoni tiegħu tirriżulta mit twaħħil mas-sottounità 30S tar-ribosome, u jipprevjeni s-sintesi tal-proteini u jiddisturba l-permeabilità tal-membrana tal-batterji.
English: • Should antimicrobial resistance be already present, develop or be acquired, then the use of antimicrobials for the treatment of clinically infected flocks, for the prevention of Salmonella infection, or for the treatment of infected flocks without clinical signs, will enhance the selection and spread of resistant bacterial strains throughout the production pyramid.
Maltese: • Jekk ir-reżistenza għall-antimikrobiċi diġà tkun preżenti, tiżviluppa jew tinkiseb, l-użu tal antimikrobiċi għall-kura ta' qatgħat infettati b'mod kliniku, għall-prevenzjoni ta' infezzjoni b'Salmonella, jew għall-kura ta' qagħat infettati mingħajr sinjali kliniċi, ser iżid l-għażla u t-tixrid ta' razez batteriċi reżistenti fil-piramida tal-produzzjoni.
English: Pigs.
Maltese: Qżieqeż.
English: Use personal protective equipment consisting of gloves, mask, goggles and protective clothing while handling the product.
Maltese: Uża tagħmir protettiv personali li jikkonsisti minn ingwanti, maskra, goggles u ħwejjeġ protettivi meta tmiss mal-prodott.
English: In support of the indication for treatment of bacterial enteritis caused by E. coli and clinical outbreaks due to Salmonella Dublin the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Maltese: Biex jappoġġja l-indikazzjoni għall-kura ta' enterite batterika kkawżata minn E. coli u tifqigħat kliniċi minħabba Salmonella Dublin, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq pprovda data in vitro dwar is-suxxettibbiltà u data klinika, inkluż studji fuq il-post.
English: Pre-ruminant calves
Maltese: TWISSIJIET SPEĊJALI
English: In addition use of apramycin was considered preferable to the potential use of more critical antimicrobials such as fluoroquinolones.
Maltese: Barra minn hekk l-użu tal-apramiċina ġie kkunsidrat bħala preferibbli għall-użu potenzjali ta' antimikrobiċi aktar kritiċi bħall-fluworokinoloni.
English: Average daily water intake (l/animal)
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U INGREDJENT(I)
English: and Campylobacter spp.
Maltese: Għall-kura tal-annimali biss.
English: MIC90 values from a large pan-European study have been calculated for apramycin against E. coli from calves as 16 μg/ml.
Maltese: Il-valuri MIC90 minn studju pan-Ewropew kbir ġew ikkalkulati għall-apramiċina kontra E. coli millħnieżer bħala 16 μg/ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Maltese: * IU - unitajiet internazzjonali
English: For multidose presentations (bottle and bag):
Maltese: Għal preżentazzjonijiet ta' dożi multipli (flixkun u borża):
English: The proposed indication was ‘Treatment of colibacillosis caused by Escherichia coli and not zoonotic Salmonella (Salmonella Pullorum and Salmonella Gallinarum) susceptible to apramycin'.
Maltese: żoonotika (Salmonella Pullorum u Salmonella Gallinarum) suxxettibbli għall-apramiċina”.
English: Apramycin administered orally to calves once daily for five days at 20 mg apramycin/kg bw or 40 mg apramycin/kg bw was effective in reducing mortality.
Maltese: L-apramiċina mogħtija mill-ħalq lill-għoġġiela darba kuljum għal ħamest ijiem b'20 mg apramiċina/kg bw jew b'40 mg apramiċina/kg bw kienet effettiva biex tnaqqas il-mortalità.
English: MIC90 of European isolates of E. coli for apramycin was demonstrated to be 8 μg/ml or less and the resistance proportion of E. coli of chicken origin against apramycin was below 10%.
Maltese: L-MIC90 ta' iżolati Ewropej ta' E. coli għall-apramiċina intweriet li kienet 8 μg/ml jew inqas u lproporzjon ta' reżistenza ta' E. coli ta' oriġini mit-tiġieġ kontra l-apramiċina kien taħt l-10%.
English: This benefit-risk evaluation is performed in the context of Article 34 of Directive 2001/82/EC, which in the present procedure has the purpose of obtaining harmonisation within the EU of the conditions of authorisation for the veterinary medicinal product Girolan.
Maltese: Din il-valutazzjoni tal-benefiċċji u r-riskji qiegħda ssir fil-kuntest tal-Artikolu 34 tadDirettiva 2001/82/KE, li fil-proċedura attwali għandha l-għan li tikseb armonizzazzjoni talkundizzjonijiet ta' awtorizzazzjoni għall-prodott mediċinali għall-użu veterinarju Girolan fl-UE.
English: Each bag contains 1,000 x 106 IU apramycin and weight of 1,812 g of product.
Maltese: Kull borża fiha 1,000 x 106 IU ta' apramycin u piż ta' 1,812 g tal-prodott.
English: Licence: CC BY-NC-SA 3.0 IGO - link show that the finished product is stable over 36 months with no significant change in active substance content.
Maltese: BY-NC-SA 3.0 IGO - link referenza twassal għall-armonizzazzjoni sħiħa tal-informazzjoni dwar il-prodott.
English: Use of the veterinary medicinal product deviating from the instructions given in the Summary of product characteristics (SPC) may increase the prevalence of bacteria resistant to the apramycin and may decrease the effectiveness of treatment with aminoglycosides due to the potential for cross-resistance.
Maltese: L-użu tal-prodott veterinarju mediċinali li ma jsegwix mill-istruzzjonijiet mogħtija fil-Karatteristiċi talProdott fil-Qosor (SPC, Summary of product characteristics) jista' jżid il-prevalenza ta' batterji reżistenti għal apramycin, u jista' jnaqqas l-effettività tat-trattament b'aminoglycosides minħabba l-potenzjal ta' reżistenza inkroċjata.
English: While it was considered that Salmonella strains are generally susceptible to apramycin (MIC≤16 μg/ml) it should be noted that only Salmonella outbreaks with clinical signs (in the case of calves, caused by Salmonella Dublin) should be treated with apramycin.
Maltese: Filwaqt li ġie kkunsidrat li r-razez ta' Salmonella ġeneralment huma suxxettibbli għall-apramiċina (MIC≤16 μg/ml) għandu jiġu nnutat li tifqigħat b'Salmonella b'sinjali kliniċi biss (fil-każ tal-għoġġiela, ikkawżati minn Salmonella Dublin) għandhom jiġu kkurati bl-apramiċina.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, routes of administration, marketing authorisation holders in the Member States
Maltese: Lista ta' ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodott mediċinali veterinarju, speċi ta' annimal, mnejn jingħata, iddetenturi ta' l-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: In this blind, randomised trial Girolan administered at 20,000 IU apramycin per kg bw (corresponding to 36 mg of product/kg bw), daily for 5 consecutive days, was compared with a reference product containing colistin at a dose of 100,000 IU colistin/kg bw/day as the control group.
Maltese: IU apramiċina għal kull kg bw (li tikkorrispondi għal 36 mg ta' prodott/kg bw), kuljum għal 5 ijiem konsekuttivi, tqabbel ma' prodott ta' referenza li fih il-kolistina b'doża ta' 100,000
English: Rabbits: Oral doses of apramycin administered from 6th to the 18th day of pregnancy (including doses below the therapeutic doses), have shown evidence of foetotoxic effects.
Maltese: Dożi orali ta' apramycin mogħtija mis-6 sat-18-il jum tat-tqala (li jinkludu dożi taħt id-dożi terapewtiċi), urew evidenza ta' effetti fetotossiċi.
English: Dose/response was clearly observed for the mortality rate.
Maltese: Id-doża/ir-rispons ġiet/ġie osservata/osservat b'mod ċar għar-rata tal-mortalità.
English: In support of the proposed indication ‘Treatment and metaphylaxis of bacterial enteritis caused by Escherichia coli susceptible to apramycin', the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Maltese: Biex jappoġġa l-indikazzjoni proposta “Kura u metafilassi ta' enterite batterika kkawżata minn Escherichia coli, suxxettibbli għallapramiċina”, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ipprovda data in vitro dwar issuxxettibbiltà u data klinika inkluż studji fuq il-post.