FrancophonIA/ELRC3.0 huggingface dataset:
English: • schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Maltese: • skiżofrenija, marda mentali b'għadd ta' sintomi, inklużi l-ħsieb u kliem diżorganizzati, alluċinazzjonijiet (smigħ jew viżjoni ta' oġġetti li mhumiex hemm), suspetti u delużjonijiet (twemmin falz).
English: Other information about Aripiprazole Mylan Pharma
Maltese: Aktar informazzjoni dwar Aripiprazole Mylan Pharma
English: Because Aripiprazole Mylan Pharma is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify.
Maltese: Billi Aripiprazole Mylan Pharma huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Abilify.
English: Since dopamine and 5-hydroxytryptamine are involved in schizophrenia and bipolar disorder, aripiprazole helps to normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning.
Maltese: Peress li d-dopamina u l-5-hydroxytryptamine huma involuti fi skiżofrenja u mard bipolari, l-aripiprażol jgħin biex iġib lura għan-normal l-attività tal-moħħ, billi jnaqqas is-sintomi psikotiċi jew sintomi ta' manija u jipprevjenihom milli jirritornaw.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku aripiprażol
English: For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Maltese: F'pazjenti ta' bejn it-13 u s-17-il sena, id-doża inizjali hija ta' 2 mg kuljum (bl-użu ta' prodott talaripiprażol f'għamla likwida), li ftit, ftit tiżdied għad-doża rakkomandata ta' 10 mg darba kuljum.
English: This means that Aripiprazole Mylan Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Abilify.
Maltese: Dan ifisser li Aripiprazole Mylan Pharma huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem ta' Abilify.
English: Because Aripiprazole Mylan Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Aripiprazole Mylan Pharma huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, jitqies li l-benefiċċji u r-riskji tiegħu huma l-istess bħal dawk tal-mediċina ta' referenza.
English: A risk management plan has been developed to ensure that Aripiprazole Mylan Pharma is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Aripiprazole Mylan Pharma jintuża bl-aktar mod sigur possibbli.
English: For more information on generic medicines, see the question-andanswer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument ta' mistoqsijiet u tweġibiet hawnhekk
English: Why is Aripiprazole Mylan Pharma approved?
Maltese: Għaliex ġie approvat Aripiprazole Mylan Pharma?
English: For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day in adults, followed by a ‘maintenance' dose of 15 mg once a day.
Maltese: Għall-iskiżofrenija, id-doża inizjali rakkomandata li tittieħed oralment hija ta' 10 jew 15-il mg kuljum għall-adulti, segwita minn doża ta' ‘manutenzjoni' ta' 15-il mg darba kuljum.
English: What are the benefits and risks of Aripiprazole Mylan Pharma?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Aripiprazole Mylan Pharma?
English: Aripiprazole Mylan Pharma aripiprazole
Maltese: Kif ġie studjat Aripiprazole Mylan Pharma?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Mylan Pharma has been shown to have comparable quality and to be bioequivalent to Abilify.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, skont irrekwiżiti tal-UE, intwera li Aripiprazole Mylan Pharma għandu kwalità komparabbli u huwa bijoekwivalenti għal Abilify.
English: To prevent manic episodes in adults, the same dose should be continued.
Maltese: Sabiex jiġu evitati episodji ta' manija f'adulti, l-istess doża għandha titkompla.
English: In patients aged between 15 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Maltese: F'pazjenti ta' bejn il-15 u s-17-il sena, id-doża inizjali hija ta' 2 mg kuljum (bl-użu ta' prodott tal-aripiprażol f'għamla likwida), li ftit, ftit tiżdied għad-doża rakkomandata ta' 10 mg darba kuljum.
English: Therefore, the CHMP's view was that, as for Abilify, the benefit outweighs the identified risk.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal fil-każ ta' Abilify, il-benefiċċji huma akbar mir-riskji identifikati.
English: How is Aripiprazole Mylan Pharma used?
Maltese: Kif jintuża Aripiprazole Mylan Pharma?
English: The Committee recommended that Aripiprazole Mylan Pharma be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Aripiprazole Mylan Pharma ikun approvat għall-użu fl-UE.
English: For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg by mouth once a day, either on its own or in combination with other medicines.
Maltese: Għall-kura ta' episodji ta' manija f'disturb bipolari, id-doża inizjali rakkomandata hija ta' 15-il mg oralment darba kuljum, jew waħedha jew f'kombinazzjoni ma' mediċini oħrajn.
English: Previously known as Aripiprazole Pharmathen.
Maltese: Preċedentement magħruf bħala Aripiprazole Pharmathen.
English: Aripiprazole Mylan Pharma is used in patients aged 15 years or over;
Maltese: Aripiprazole Mylan Pharma jintuża f'pazjenti ta' 15-il sena jew aktar;
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Mylan Pharma, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: Abbażi ta' dan il-pjan, fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward is-sigurtà ta' Aripiprazole Mylan Pharma, inklużi lprekawzjonijiet xierqa li għandhom ikunu segwiti mill-professjonisti tal-kura tas-saħħa u l-pazjenti.
English: For further information, see the Summary of Product Characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni, ara s-Sommarju talKaratteristiċi tal-Prodott (parti wkoll mill-EPAR).
English: A. et al,.
Maltese: et al,.
English: Overall benefit-risk
Maltese: Benefiċċji u riskji globali
English: Polígono Agro-Reus
Maltese: Poligono Agro-Reus
English: SP VETERINARIA Ctra.Reus-Vinyols, Km, 43330 Ruidoms SPAIN
Maltese: SP VETERINARIA Ctra.Reus-Vinyols, Km, 43330
English: J. Appl.
Maltese: Appl.
English: Regarding S. aureus, 89% (2009) and 82% (2010) of the bacterial isolates were susceptible to enrofloxacin.
Maltese: Rigward S. aureus, 89% (2009) u 82% (2010) tal-iżolati batterjali kienu suxxettibbli għal enrofloksaċina.
English: Farmacêuticos e Cosméticos SA Av. Infante D. Henrique nº333 H 3º Piso Esc.
Maltese: Henrique nº333 H 3º Piso Esc.
English: VETPHARMA ANIMAL HEALTH, S.L.
Maltese: VETPHARMA ANIMAL HEALTH, S.L. Les Corts, 23
English: Of the strains examined, 86.67% were susceptible to enrofloxacin, 10% were intermediate and 3.33% were resistant.
Maltese: Mir-razez studjati, 86.67% kienu suxxettibbli għal enrofloksaċina, 10% kienu intermedji u 3.33% kienu reżistenti.
English: Benefit-Risk Assessment
Maltese: 3. Valuazzjoni Benefiċċji-Riskji
English: 1 CVMP Public statement on the use of (fluoro)quinolones in food-producing animals in the European Union: development of resistance and impact on human and animal health (2007) (EMEA/CVMP/SAGAM/184651/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2009/10/WC500005152.pdf
Maltese: 1 CVMP Public statement on the use of (fluoro)quinolones in food-producing animals in the European Union: development of resistance and impact on human and animal health (2007) (EMEA/CVMP/SAGAM/184651/2005)
English: Medivet S.A. Szkolna 17
Maltese: Medivet S.A. Szkolna 17 63-100 Śrem POLU
English: 7 CVMP Reflection paper on the use of fluoroquinolones in food- producing animals - Precautions for use in the SPC regarding prudent use guidance (EMEA/CVMP/416168/2006)http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500005173.pdf that are less likely to produce resistances of public health concern are used as a first option instead of fluoroquinolones.
Maltese: 7 CVMP Reflection paper on the use of fluoroquinolones in food- producing animals - Precautions for use in the SPC regarding prudent use guidance (EMEA/CVMP/416168/2006)http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500005173.pdf
English: The enrofloxacin is an antimicrobial belonging to the class of fluoroquinolones, which are listed by the WHO as a critically important class of antimicrobials for human health (Critically important antimicrobials for human medicine, WHO/AGISAR, Copenhagen, 2009).
Maltese: L-enrofloksaċina hija antimikrobjali li tappartjeni għall-klassi ta' fluworokinoloni, li huma elenkati millWHO bħala klassi ta' importanza kritika ta' antimikrobjali għal saħħet il-bniedem (Antimikrobjali ta' importanza kritika għall-mediċina tal-bniedem, WHO/AGISAR, Copenhagen, 2009).
English: From the RESAPATH annual reports, the highest susceptibility levels to enrofloxacin in E. coli in rabbits were 90% (2009) and 85% (2010).
Maltese: Mir-rapporti annwali ta' RESAPATH, il-livelli ogħla ta' suxxettibilità għal enrofloksaċina f'E. coli fi fniek kienu ta' 90% (2009) u 85% (2010).
English: In another study carried out in Spain in 2011 to address the evolution of the level of resistances the MIC50 and the MIC90 of the P. multocida strains examined were 0.125 and 0.380 µg/ml, respectively.
Maltese: Fi studju ieħor li sar fi Spanja fl-2011 biex jittratta l-evoluzzjoni tal-livell tar-reżistenzi l-MIC50 u l-MIC90 tar-razez ta' P. multocida eżaminati kienu 0.125 u 0.380 µg/ml, rispettivament.
English: The data from published literature (RESAPATH annual reports) show that the sensitivity of P. multocida strains to enrofloxacin in rabbits was high (100% and 99% in 2009 and 2010, respectively).
Maltese: Id-dejta mir-reċensjoni ppubblikata (irrapporti annwali ta' RESAPATH) turi li s-sensittività ta' razez ta' P. multocida għall-enrofloksaċina filfniek kienet għolja (100% u 99% fl-2009 u fl-2010, rispettivament).
English: The conclusion of a comparative study of plasma levels of enrofloxacin and its metabolite ciprofloxacin during treatment with the product at doses equivalent to 5 and 10 mg/kg bw of enrofloxacin administered in drinking water for 5 consecutive days was that the effective dose regimen of enrofloxacin for the treatment of respiratory infections caused by P. multocida in rabbits is 10 mg/kg bw.
Maltese: Il-konklużjoni tal-istudju komparattiv tal-livelli ta' enrofloksaċina u tal-metabolit tagħha ciprofloxacin fil-plażma waqt il-kura bil-prodott f'dożi ekwivalenti għal 5 u 10 mg/kg bw ta' enrofloksaċina mogħtija fl-ilma tax-xorb għal ħamest ijiem konsekuttivi kienet li l-kors ta' doża effettiva ta' enrofloksaċina għall-kura ta' infezzjonijiet respiratorji kkawżati minn P. multocida filfniek hija 10 mg/kg bw.
English: These species account for 85% of the animal (meat) production whilst e.g. rabbits only account for 0.7% of the French animal production (EMA, 2011)6, France being one of the biggest rabbit producers in the EU.
Maltese: Dawn l-ispeċi jammontaw għal 85% tal-produzzjoni tal-annimali (laħam) filwaqt li, eż. il-fniek jammontaw biss għal 0.7% tal-produzzjoni tal-annimali ta' Franza (EMA, 2011)6, u ta' min jinnota li Franza hija waħda millikbar produtturi ta' fniek fl-UE.
English: Poligono Agro-Reus 43206 Reus SPAIN
Maltese: Polígono Agro-Reus 43206 Reus
English: Sensitivity of various strains of P. multocida was analysed in Spain between 2009 and 2011 and the antibiogram results showed that of a total of 61 P. multocida isolates all 61 strains were sensitive.
Maltese: Bejn l-2009 u l-2011, fi Spanja, ġiet analizzata s-sensittività ta' bosta razez ta' P. multocida u r-riżultati tal-antibijogramma wrew li minn total ta' 61 iżolat ta' P. multocida, kull wieħed mill-61 razza kien sensittiv.
English: Several MIC data on P. multocida isolated from clinical samples from 30 Spanish rabbit farms in 2006 and 2007 were provided.
Maltese: Ġiet ipprovduta ħafna dejta minn MICs dwar P. multocida iżolat minn kampjuni kliniċi meħuda fl-2006 u fl-2007 minn 30 razzett tal-fniek fi Spanja.
English: HIPRALONA ENRO-S and its generics were involved in the referral under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing quinolones including fluoroquinolones intended for use in food-producing species (EMEA/V/A/049) and the adequate prudent use warnings were recommended for these products.
Maltese: HIPRALONA ENRO-S u l-ġeneriċi tiegħu kienu involuti fir-riferiment taħt l-Artikolu 35 tadDirettiva 2001/82/KE għall-prodotti mediċinali veterinarji kollha li fihom il-kinoloni, inklużi ilfluworokinoloni maħsuba għall-użu fi speċijiet li jipproduċu l-ikel (EMEA/V/A/049) u t-twissijiet adegwati għall-użu prudenti ġew irrakkomandati għal dawn il-prodotti.
English: Calle Capcanes n12 Bajos
Maltese: SL C/Capçanes nº12-bajos
English: Sensitivity analysis to identify key parameters influencing Salmonella infection dynamics in a pig batch.
Maltese: Sensitivity analysis to identify key parameters influencing Salmonella infection dynamics in a pig batch. 2009, May 7, 258(1):43-52.
English: On 30 September 2011, France initiated a referral under Article 35 of Directive 2001/82/EC, as amended, for the veterinary medicinal product HIPRALONA ENRO-S and its generics indicated for use in rabbits.
Maltese: Fit-30 ta' Settembru 2011, Franza bdiet riferiment skont l-Artikolu 35 tad-Direttiva 2001/82/KE, kif emendata, għall-prodott mediċinali veterinarju HIPRALONA ENRO-S u l-ġeneriċi tiegħu indikati għallużu fil-fniek.
English: A et al2, 2006, Belloc et al3, 2005, Lurette A. et al4, 2009, Mathieu.
Maltese: et al4, 2009, Mathieu.
English: Data on susceptibility of enrofloxacin from a study conducted in Spain in 2005 showed a MIC90 of 0.06 µg/ml.
Maltese: Dejta dwar is-suxxettibbiltà ta' enrofloksaċina minn studju li sar fi Spanja fl-2005 wera MIC90 ta' 0.06 μg/ml.
English: Risk to public health due to spread of resistant bacteria from treated animals Data from the RESAPATH 2009 and 2010 annual reports (French surveillance network for antimicrobial resistance in pathogenic bacteria of animal origin) were provided.
Maltese: Riskju għas-saħħa pubblika minħabba tifrix ta' batterji reżistenti minn annimali ttrattati Ġiet ipprovduta d-dejta mir-rapporti annwali 2009 u 2010 ta' RESAPATH (netwerk ta' sorveljanza Franċiż għar-reżistenza antimikrobjali f'batterji patoġeniċi ta' oriġini minn annimali).
English: Most of the MICs obtained were above the range expected for wild-type isolates, data from EUCAST (European Committee on Antimicrobial Susceptibility Testing) indicate that the distribution of MICs of enrofloxacin for the wild type of the target pathogen, P. multocida, is between 0.004 and 0.03 µg/ml.
Maltese: Ħafna mill-MICs miksuba kienu ogħla mill-medda mistennija għall-iżolati tat-tip selvaġġ, dejta minn EUCAST (il-Kumitat Ewropew dwar l-Ittestjar tas-Suxxettibbiltà Antimikrobika) tindika li d-distribuzzjoni tal-MICs ta' enrofloksaċina għat-tip selvaġġ tal-patoġenu fil-mira, P. multocida, hija bejn 0.004 u 0.03 µg/ml.
English: Unfortunately, there is insufficient information on the interpretation criteria used on the RESAPATH annual reports.
Maltese: Sfortunatament, m'hemmx biżżejjed informazzjoni dwar il-kriterji ta' interpretazzjoni użati fir-rapporti annwali ta' RESAPATH.
English: Global Vet Health S.L.
Maltese: GLOBAL VET HEALTH
English: Capsanes, 12 - Polígono Agro-Reus E-43206 - REUS (Tarragona) SPAIN
Maltese: GLOBAL VET HEALTH, S.L. Capsanes, 12 - Polígono Agro-Reus E-43206 - REUS (Tarragona) SPAIN
English: The dosage is 10 mg enrofloxacin per kg bodyweight (bw) during 5 days.
Maltese: Id-doża hija 10 mg enrofloksaċina għal kull kg piż tal-ġisem (bw) għal ħamest (5) ijiem.
English: HIPRALONA ENRO-S, and its generics, contain enrofloxacin as active ingredient, and are indicated in rabbits for the treatment of respiratory infections due to Pasteurella multocida.
Maltese: HIPRALONA ENRO-S, u l-ġeneriċi tiegħu, fihom enrofloksaċina bħala s-sustanza attiva, u huma indikati fil-fniek għall-kura ta' infezzjonijiet respiratorji kkawżati minn Pasteurella multocida.
English: Oral solution Chickens (Broilers, replacement chickens, broiler breeders),
Maltese: Tiġieġ (Brojlers, tiġieġ ta' sostituzzjoni, nissiela talbrojlers), Fniek
English: There are two risks for public health identified with the use of enrofloxacin in rabbits: (i) the risk for spread of methicillin resistant Staphylococcus aureus (MRSA) from rabbits to people in contact with these animals and (ii) the risk of spread of resistant zoonotic bacteria and transmissible resistance genes via food, e.g. Salmonella and E. coli.
Maltese: Jeżistu żewġ riskji għas-saħħa pubblika identifikati bl-użu ta' enrofloksaċina fil-fniek: (i) ir-riskju tattixrid ta' methicillin resistant Staphylococcus aureus (MRSA) mill-fniek għan-nies li jiġu f'kuntatt ma' dawn l-annimali u (ii) ir-riskju tat-tixrid ta' batterji żoonotiċi reżistenti u ġeni ta' reżistenza trażmissibbli permezz tal-ikel, eż.
English: K-FLOX 100 mg/ml Oral Solution for chickens and rabbits.
Maltese: K-FLOX 100 mg/ml Oral solution for chicken and rabbits.
English: The pharmacokinetic/pharmacodynamic relationship was discussed in relation to the dosage regimens for the clinical trials provided.
Maltese: Ir-relazzjoni farmakokinetika/farmakodinamika ġiet diskussa fir-rigward tal-korsijiet tad-dożi għallprovi kliniċi pprovduti.
English: Enrofloxacin is for veterinary use only.
Maltese: Enrofloksaċina għandha użu veterinarju biss.
English: aureus (skin disease).
Maltese: Staph. aureus (marda tal-ġilda).
English: Risk for public health
Maltese: Riskju għas-saħħa pubblika
English: From the route of administration it can be concluded that the risk of rabbit treatment would be similar to that of poultry.
Maltese: Minn mnejn jingħata, jista' jiġi konkluż li r-riskju ta' trattament tal-fniek ikun simili għal dak tat-tjur.
English: LEVOFLOK® 100 mg/ml Oral solution for chickens and rabbits
Maltese: LEVOFLOK® 100 mg/ml Oral solution for chicken and rabbits
English: Belgium GLOBAL VET HEALTH SL C/Capçanes nº12-bajos
Maltese: Ir-Renju Unit Global Vet Health S.L. Calle Capcanes n12 Bajos
English: GLOBAL VET HEALTH SL C / Capçanes n º 12-bajos Polígono Agro-Reus 43206 Reus
Maltese: SL C / Capçanes n º 12-bajos Polígono Agro-Reus 43206 Reus
English: The treatment did not affect the estimated water consumption of animals (about 100 ml/kg body weight).
Maltese: It-trattament ma affettwax il-konsum stmat ta' ilma tal-annimali (madwar 100 ml/kg piż tal-ġisem).
English: GLOBAL VET HEALTH SL c/Capçanes, nº12-bajos.
Maltese: SL c/Capçanes, nº12-bajos.
English: HIPRALONA ENRO-S and its generics contain 100 mg enrofloxacin per ml oral solution for use in drinking water.
Maltese: HIPRALONA ENRO-S u l-ġeneriċi tiegħu fihom 100 mg enrofloksaċina għal kull ml soluzzjoni orali għallużu fl-ilma tax-xorb.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, applicant/marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali veterinarji, speċi tal-annimali, mnejn jingħata, lapplikant/ id-detenturi tal-awtorizzazzjoni għat-tqegħid fuq is-suq fl-Istati Membri
English: • the CVMP considered that the overall benefit-risk balance is positive for the products concerned by this procedure; the CVMP recommended the maintenance of the marketing authorisations for the veterinary medicinal product HIPRALONA ENRO-S and its generics (see Annex I) in accordance with the previously approved product information.
Maltese: • is-CVMP ikkunsidra li l-bilanċ globali bejn il-benefiċċji u r-riskji huwa wieħed pożittiv għall-prodotti inkwistjoni f'din il-proċedura; is-CVMP irrakkomanda ż-żamma tal-awtorizzazzjonijiet għat-tqegħid fis-suq għall-prodott mediċinali veterinarju HIPRALONA ENRO-S u l-ġeneriċi tiegħu (ara l-Anness I) skont l-informazzjoni dwar ilprodott approvata qabel.
English: A comprehensive review of the published data was provided.
Maltese: Ġiet ipprovduta analiżi komprensiva tad-dejta ppubblikata.
English: The safety and efficacy of the product have been demonstrated in a well conducted GCP compliant trial that fulfils the requirements of Directive 2001/82/EC and the relevant guidelines using a dose of 10 mg/kg bw for 5 consecutive days.
Maltese: Is-sikurezza u l-effikaċja tal-prodott intwerew fi prova klinika konformi malGCP li saret sew u li tissodisfa r-rekwiżiti tad-Direttiva 2001/82/KE u l-linji gwida rilevanti li użat doża ta' 10 mg/kg bw għal ħamest ijiem konsekuttivi.
English: France considered that these resistances would possibly be directly or indirectly transmitted to humans and may represent a potential serious risk to public health as enrofloxacin belongs to the fluoroquinolones family which is considered a highly critical class of antimicrobials for human health.
Maltese: Franza qieset li dawn ir-reżistenzi jistgħu jiġu trażmessi b'mod dirett jew indirett lill-bnedmin u jistgħu jirrappreżentaw riskju potenzjali serju għas-saħħa pubblika minħabba li enrofloksaċina tappartjeni għall-familja ta' fluworokinoloni meqjusa bħala klassi ferm kritika ta' antimikrobjali għas-saħħa talbniedem.
English: The CVMP was requested to give its opinion as to whether the benefit-risk ratio for HIPRALONA ENRO-S and its generics is positive when the products are administered to rabbits and whether the introduction of such highly critical antibiotics in a food production species, used via oral route, is in line with the current recommendations to implement prudent use of antimicrobials (EMEA/CVMP/SAGAM/184651/2005)1.
Maltese: Is-CVMP intalab jagħti l-opinjoni tiegħu dwar jekk il-proporzjon tal-benefiċċju u tar-riskju għal HIPRALONA ENRO-S u l-ġeneriċi tiegħu ikunx pożittiv meta l-prodotti jingħataw lill-fniek u jekk lintroduzzjoni ta' antibijotiċi ferm kritiċi bħal dawn fi speċi li tipproduċi l-ikel, mogħtija mill-ħalq, tkunx konformi mar-rakkomandazzjonijiet attwali għall-implimentazzjoni ta' użu prudenti ta' antimikrobjali (EMEA/CVMP/SAGAM/184651/2005)1.
English: Oral solution Chickens (broilers),
Maltese: Tiġieġ (brojlers), Fniek
English: The concerns raised by France were that the use of HIPRALONA ENRO-S and its generics in rabbit production would increase Escherichia coli and Staphylococcus aureus resistance to enrofloxacin.
Maltese: It-tħassib imqajjem minn Franza kien li l-użu ta' HIPRALONA ENRO-S u l-ġeneriċi tiegħu fil-produzzjoni tal-fniek iżid ir-reżistenza ta' Escherichia coli u Staphylococcus aureus għall-enrofloksaċina.
English: A second pharmacokinetic study was carried out in order to confirm the dose.
Maltese: Sar studju farmakokinetiku ieħor biex id-doża tkun ikkonfermata.
English: Regarding the second risk, spread of resistant zoonotic bacteria and resistance genes via food, this is a well characterised risk for which CVMP in November 2006 recommended risk mitigation measures7.
Maltese: Rigward it-tieni riskju, it-tifrix ta' batterji żoonotiċi reżistenti u ġeni ta' reżistenza permezz tal-ikel, dan huwa riskju kkaratterizzat sew li għalih is-CVMP irrakkomanda miżuri ta' tnaqqis tar-riskju f'Novembru 20067.