FrancophonIA/ELRC3.0 huggingface dataset:
English: Rapilysin 10 U powder and solvent for solution for injection Reteplase Intravenous use
Maltese: U MNEJN GĦANDU JINGĦATA Rapilysin 10 U trab u solvent għal soluzzjoni għall-injezzjoni Reteplase użu għal ġol-vini
English: Each injection should be given slowly within 2 minutes.
Maltese: Kull injezzjoni hija mogħtija bil-mod ġol-vini f'temp ta' 2 minuti.
English: Reteplase is supplied as a freeze-dried substance in vials.
Maltese: Reteplase huwa pprovdut bħala sustanza imnixxfa permezz ta' friża f'kunjetti.
English: As with other thrombolytic agents these cardiovascular events have been reported as sequelae of myocardial infarction and/or thrombolytic administration.
Maltese: Bħal ma' sustanzi trombolitiċi oħra dawn l-avvenimenti kardjovaskulari ġew irrappurtati bħala konsegwenza ta' infart mijokardijaku u/jew amministrazzjoni trombolitika.
English: Insert the spike through the rubber closure into the vial of Rapilysin 10 U.
Maltese: Ikkonnettja ssiringa ma' l-‘spike' għar-rikostituzzjoni u ittrasferixxi l-10 ml tas-solvent fil-kunjett ta' Rapilysin 10 U.
English: Heparin and acetylsalicylic acid are given before and after Rapilysin to reduce the risk of new blood clots forming.
Maltese: Heparin u acetylsalicylic acid huma mogħtija qabel u wara Rapilysin biex inaqqsu ir-riskju ta' formazzjoni ta' emboli ġodda.
English: 1 vial + 1 ampoule l t o r
Maltese: 1 kunjett + 1 ampulla t x
English: Fill volume (concentration)
Maltese: Kontenut (konċentrazzjoni)
English: Target species
Maltese: Speċi fil-mira
English: EMA Number
Maltese: Numru tal-EMA Isem Ivvintat
English: MA (EU) number (Invented) name
Maltese: Numru l-EU Isem inventat
English: --¹ Each dose of vaccine suspension (3 ml) contains:
Maltese: 5.6 g Vaċċin: 3 ml;
English: Vibrio cholerae O1 Ogawa, classical biotype (heat inactivated)
Maltese: Vibrio cholerae O1 Ogawa, bijo-tip klassiku (inattivat bis-sħana) Vibrio cholerae O1 Ogawa, bijo-tip klassiku (inattivat bil-formalina)
English: Vibrio cholerae O1 Inaba, El Tor biotype (formalin inactivated)
Maltese: Vibrio cholerae O1 Inaba, bijo-tip klassiku (inattivat bis-sħana) Vibrio cholerae O1 Inaba, bijo-tip El Tor (inattivat bil-formalina)
English: Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 31.25x109 bacteria - Recombinant cholera toxin B subunit (rCTB) 1 mg
Maltese: − Subunit ta' tossina B tal-kolera rikombinanti (rCTB) 1 mg
English: EU/1/08/469/054 Oprymea 0.26 mg + 0.52 mg +
Maltese: 21 pillola (7 x 0.26 mg + 7 x 0.52 mg + 7 x 1.05 mg)
English: 1.05 mg
Maltese: 0.26 mg + 0.52 mg + 1.05 mg
English: Centro Empresarial da Rainha, Lote 27 2050-501 Vila Nova da Rainha Portugal
Maltese: Centro Empresarial da Rainha, Lote 27 2050-501 Vila Nova da Rainha
English: Falagas ME et al. 2005 Colistin: the revival of polymyxins for the management of multidrug-resistant Gram-negative bacterial infections.
Maltese: ME et al. 2005 Colistin: the revival of polymyxins for the management of multidrug-resistant Gram-negative bacterial infections.
English: Centurii nr.7
Maltese: Sos. Centurii nr.7
English: Romania SC ROMVAC COMPANY SA
Maltese: Ir-Rumanija SC ROMVAC COMPANY SA
English: SkanVet Poland Sp. z o.o.
Maltese: Il-Polonja SkanVet Poland Sp. z o.o.
English: 2625-170 Póvoa de Santa Iria
Maltese: 2625-170 Póvoa de Santa Iria Portugal
English: Premaxol, 100 mg/g + 40 mg/g de prémistura medicamentosa para alimento medicamentoso para suínos, frangos e galinhas (excepto poedeiras)
Maltese: Premaxol, 100 mg/g + 40 mg/g de pré-mistura medicamentosa para alimento medicamentoso para suínos, frangos e galinhas (excepto poedeiras)
English: Romania COOPHAVET SAS Herblon
Maltese: Ir-Rumanija COOPHAVET SAS Herblon
English: Arnika Veterina d.o.o.
Maltese: Il-Kroazja Arnika Veterina d.o.o.
English: Catry, B et al. 2015 Use of colistin-containing products within the European Union and European Economic Area (EU/EEA): development of resistance in animals and possible impact on human and animal health.
Maltese: Use of colistin-containing products within the European Union and European Economic Area (EU/EEA): development of resistance in animals and possible impact on human and animal health.
English: Farma vet Ltd. 40 Otec Paisii str. Shumen
Maltese: Il-Bulgarija Farma vet Ltd. 40 Otec Paisii str.
English: Cosgrove SE 2006 The relationship between antimicrobial resistance and patient outcomes: mortality, length of hospital stay, and health care costs.
Maltese: The relationship between antimicrobial resistance and patient outcomes: mortality, length of hospital stay, and health care costs.
English: Liu YY et al. 2015 Emergence of plasmid-mediated colistin resistance mechanism MCR-1 in animals and human beings in China: a microbiological and molecular biological study.
Maltese: Emergence of plasmid-mediated colistin resistance mechanism MCR-1 in animals and human beings in China: a microbiological and molecular biological study.
English: Vodovodna 20a 10000 Zagreb Croatia
Maltese: Vodovodna 20a 10000
English: CENAVISA, S.A. Camí Pedra Estela s/n. Reus (Tarragona)
Maltese: CENAVISA, S.A. Camí Pedra Estela s/n.
English: Rhone Vet Kft.
Maltese: L-Ungerija Rhone Vet Kft. Petőfi u.
English: Luxembourg VETOQUINOL Magny Vernois 70200 Lure
Maltese: VETOQUINOL Magny Vernois 70200
English: 7 Saint Herblon 44153 ANCENIS
Maltese: B.P. 7 Saint Herblon 44153 ANCENIS
English: Use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health (EMA/755938/2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146813.pdf European Medicines Agency, European Surveillance of Veterinary Antimicrobial Consumption.
Maltese: Use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health (EMA/755938/2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146813.pdf
English: 7 Saint Herblon 44153 ANCENIS Cedex
Maltese: B.P. 7 Saint Herblon 44153 ANCENIS Cedex
English: Via Affarosa, 4 42010 - Rio Saliceto Italy
Maltese: Via Affarosa, 4 42010
English: Poultry (grouse and web-footed)
Maltese: Tjur (gallozz u webfooted)
English: Fatro S.p.A Via Emilia Nº 285 Ozzano Emilia Italy
Maltese: Fatro S.p.A Via Emilia Nº 285
English: , polymyxins were the fifth most sold group of antimicrobials (6%), after tetracyclines (37%), penicillins (24%), sulfonamides (10%) and macrolides (7%).
Maltese: , il-polimiksini kienu l-ħames l-aktar grupp mibjugħ ta' antimikrobiċi (6%), wara ttetraċilini (37%), il-peniċillini (24%), is-sulfonamidi (10%) u l-makrolidi (7%).
English: Netherlands Dopharma B.V. Zalmweg 24
Maltese: Il-Polonja Dopharma B.V. Zalmweg 24
English: Romania Industria Italiana Integratori Trei
Maltese: Ir-Rumanija Industria Italiana Integratori Trei
English: Curr Opin Infect Dis 22:535-43.
Maltese: Curr Opin Infect Dis 22:535-43. Cosgrove SE 2006
English: Via Caldera 21 20153 Milano Italy
Maltese: Virbac S.r.l. Via Caldera 21 20153 Milano Italy
English: Pogue JM et al. 2011 Revisiting ‘older' antimicrobials in the era of multidrug resistance.
Maltese: Pogue JM et al. 2011 Revisiting ‘older' antimicrobials in the era of multidrug resistance. Pharmacotherapy 31:912-21.
English: CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004645.pdf as described in the CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005).
Maltese: CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004645.pdf appoġġata l-ebda indikazzjoni gastrointestinali għall-prodotti ta' kombinazzjoni tal-colistin ma' antimikrobiċi oħra.
English: Barcelona 08017 Spain
Maltese: Via Augusta, 302. Barcelona 08017 Spain
English: Sales of combination products with colistin represented less than 10% of the overall sales of colistin (ESVAC, unpublished data).
Maltese: Il-bejgħ ta' prodotti ta' kombinazzjoni bil-colistin kien jirrappreżenta anqas minn 10% tal-bejgħ globali talcolistin (ESVAC, data mhux ippubblikata).
English: Fite A et al. 2013 Longitudinal analyses of gut mucosal microbiotas in ulcerative colitis in relation to patient age and disease severity and duration.
Maltese: Fite A et al. 2013 Longitudinal analyses of gut mucosal microbiotas in ulcerative colitis in relation to patient age and disease severity and duration. J Clin Microbiol 51:849-56.
English: Callens B et al. 2012 Prophylactic and metaphylactic antimicrobial use in Belgian fattening pig herds.
Maltese: J Antibiot (Tokyo) 3:457-8. Callens B et al. 2012 Prophylactic and metaphylactic antimicrobial use in Belgian fattening pig herds.
English: 3.75 g 50 MIU
Maltese: 3.75 g 50
English: Lithuania COOPHAVET S.A.S.
Maltese: Il-Litwanja COOPHAVET S.A.S.
English: Benefit-risk assessment
Maltese: 3. Valutazzjoni benefiċċji-riskji
English: Colistin is a cationic, multicomponent lipopeptide antibacterial agent produced by cultures of Bacillus polymyxa var. colistinus.
Maltese: Il-colistin huwa sustanza antibatterika lipopeptide katjonika, b'ħafna komponenti, prodotta minn kulturi ta' Bacillus polymyxa var. colistinus.
English: A recent paper identified another risk of colistin products and Salmonella spp.
Maltese: Dokument riċenti identifika riskju ieħor tal-prodotti li fihom il-colistin u s-Salmonella spp.
English: Romania Lavet Pharmecuticals LTD.
Maltese: Ir-Rumanija Lavet Pharmecuticals
English: Bioweterynaryjnego S.A ul.
Maltese: Il-Polonja Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A ul.
English: In view of the information available in the reports of the EMA European Surveillance of Veterinary Antimicrobial Consumption
Maltese: European Medicines Agency, European Surveillance of Veterinary Antimicrobial Consumption.
English: Polymyxins have no clinically useful activity against Gram-positive bacteria, Gram-negative cocci, anaerobes and Mollicutes including Mycoplasma spp.
Maltese: Il-polimiksini ma għandhom l-ebda attività klinikament utli kontra batterji Gram-pożittivi, kokki Gram-negattivi, anerobji u Mollicutes, inkluż ilMycoplasma spp.
English: Pigs, chicken (broilers)
Maltese: Ħnieżer, tiġieġ (brojlers)
English: Oral administration individually
Maltese: Amministrazzjoni orali individwalment
English: During a routine surveillance project on antimicrobial resistance in commensal E. coli from food animals in China, polymyxin resistance was shown to be singularly due to the plasmid-mediated mcr-1 gene Furthermore, this mcr-1 carriage in E. coli isolates was also found in 78 (15%) of 523 samples of raw meat products and 166 (21%) of 804 animals sampled during 2011-14.
Maltese: Barra minn hekk, dan l-mcr-1 carriage f'iżolati tal-E. coli nstab ukoll fi 78 (15%) minn 523 kampjun ta' prodotti tal-laħam mhux imsajjar u f'166 (21%) minn 804 annimali meħuda bħala kampjun matul il-perjodu 2011-14.
English: Murgašova 5 949 01 Nitra Slovakia
Maltese: 949 01 Nitra
English: A recent global increase in Gram-negative bacteria in human medicine that are multidrug-resistant (MDR), extensively drug-resistant (XDR) and pandrug-resistant (PDR)
Maltese: Żieda globali riċenti f'batterji Gram-negattivi fil-mediċina umana li huma reżistenti għal ħafna mediċini (MDR), estensivament reżistenti għall-mediċini (XDR) u reżistenti għall-mediċina pan (PDR)
English: For food-producing animals in the EU/EEA today, field studies have shown that it is used primarily for pigs including group treatments and prevention of diarrhoea caused by E. coli and Salmonella spp., as first-choice http://www.ema.europa.eu/docs/en_GB/document_library/Report/2014/10/WC500175671.pdf Commission Decision concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for all veterinary medicinal products containing "Colistin" to be administered orally ((2015)1916 of 16/03/2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm Lim LM et al. 2010 Resurgence of colistin: a review of resistance, toxicity, pharmacodynamics, and dosing.
Maltese: Fourth ESVAC report. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2014/10/WC500175671.pdf Commission Decision concerning, in the framework of Article 35 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for all veterinary medicinal products containing "Colistin" to be administered orally ((2015)1916 of 16/03/2015) http://ec.europa.eu/health/documents/community-register/html/vo25478.htm Lim LM et al. 2010
English: In addition, colistin lacks therapeutic activity against inherently resistant species, including the genera Serratia, Stenotrophomonas and Proteus
Maltese: Barra minn hekk, il-colistin m'għandux attività terapewtika kontra speċi inerentement reżistenti, inklużi l-ispeċi Serratia, Stenotrophomonas u Proteus
English: In the present Article 35 referral, several colistin combinations veterinary medicinal products were identified with colistin doses of below 50,000 IU per kg body weight.
Maltese: Fir-riferiment preżenti skont l-Artikolu 35, kienu identifikati diversi prodotti mediċinali veterinarji ta' kombinazzjoni tal-colistin ma' antimikrobiċi oħra, b'dożi tal-colistin ta' anqas minn 50,000 IU għal kull kg tal-piż tal-ġisem.
English: Previous CVMP conclusions applicable to colistin combination products
Maltese: Konklużjonijiet preċedenti tas-CVMP applikabbli għall-prodotti ta' kombinazzjoni tal-colistin ma' antimikrobiċi oħra
English: The disk diffusion test is applied routinely worldwide yet is seldom reliable due to the inability of colistin to regularly diffuse in the agar and produce a consistent concentration gradient.
Maltese: It-test tad-diffużjoni tad-disk huwa applikat b'mod regolari madwar id-dinja kollha, madankollu huwa rarament affidabbli minħabba n-nuqqas ta' abilità tal-colistin li jixtered b'mod regolari fl-agar u jipproduċi gradjent ta' konċentrazzjoni konsistenti.
English: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2015/10/WC500195687.pdf Magiorakos AP et al. 2012 Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance.
Maltese: Fifth ESVAC report. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2015/10/WC500195687.pdf Magiorakos AP et al. 2012 Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria:
English: COLISULTRIX plv.
Maltese: COLISULTRIX plv. sol.
English: Pharmaceuticals Ltd. Ottó u.14
Maltese: Ottó u.14
English: In a previous Article 35 referral procedure for all veterinary medicinal products containing colistin to be administered orally the Committee agreed a harmonised indication, a limitation of the duration of treatment up to 7 days and warning sentences on prudent use.
Maltese: Fi proċedura ta' riferiment preċedenti skont l-Artikolu 35 għall-prodotti mediċinali veterinarji kollha li fihom colistin li għandhom jiġu amministrati b'mod orali, il-Kumitat qabel dwar indikazzjoni armonizzata, limitazzjoni tat-tul tal-kura sa 7 ijiem u sentenzi ta' twissija dwar l-użu prudenti.
English: Oral paste
Maltese: Pejst orali
English: This combined with the lack of quality clinical studies and of other credible evidence to confirm the added value of colistin combination products over monotherapy, combined with lack of compliance with prudent use principles and the CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005), leads to the conclusion that there is no valid justification for the use of colistin combination products in veterinary medicine.
Maltese: Dan flimkien man-nuqqas ta' studji kliniċi ta' kwalità u ta' evidenza kredibbli oħra sabiex jikkonfermaw il-valur miżjud tal-prodotti ta' kombinazzjoni tal-colistin ma' antimikrobiċi oħra fuq monoterapija, flimkien man-nuqqas ta' konformità mal-prinċipji tal-użu prudenti u l-linja gwida tas-CVMP dwar prodotti farmaċewtiċi ta' kombinazzjoni fissa (EMEA/CVMP/83804/2005), iwassal għall-konklużjoni li ma hemm ebda ġustifikazzjoni valida għall-użu ta' prodotti ta' kombinazzjoni tal-colistin ma' antimikrobiċi oħra fil-mediċina veterinarja.
English: Combinations of colistin with other antimicrobials are available for group treatments of gastrointestinal and respiratory infections in food-producing animals in some European Member States.
Maltese: Il-kombinazzjonijiet tal-colistin ma' antimikrobiċi oħra huma disponibbli għall-kura fi gruppi ta' infezzjonijiet gastrointestinali u respiratorji f'annimali li jipproduċu likel f'xi Stati Membri Ewropej.
English: The vast majority of consumption of polymyxins in food-producing animals is accounted for by colistin administered orally, in a variety of different formulations (e.g. premix, powder, oral solutions).
Maltese: Il-maġġoranza kbira talkonsum tal-polimiksini fl-annimali li jipproduċu l-ikel isir permezz tal-colistin amministrat b'mod orali, f'varjetà ta' formulazzjonijiet differenti (eż. taħlita lesta minn qabel, trab, soluzzjonijiet orali).
English: In May 2014 the European Commission initiated a referral procedure under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing colistin as sole active substance for oral administration to food-producing species (EMEA/V/A/106).
Maltese: F'Mejju 2014 il-Kummissjoni Ewropea tat bidu għal proċedura ta' riferiment skont l-Artikolu 35 tadDirettiva 2001/82/KE għall-prodotti mediċinali veterinarji kollha li fihom il-colistin bħala l-unika sustanza attiva għall-amministrazzjoni orali lil speċi li jipproduċu l-ikel (EMEA/V/A/106).
English: Following the Article 35 referral procedure for veterinary medicinal products containing colistin as sole active substance (EMEA/V/A/106), colistin is no longer recommended for treatment of gastrointestinal infections caused by Salmonella spp.
Maltese: Wara l-proċedura ta' riferiment skont l-Artikolu 35 għal prodotti mediċinali veterinarji li fihom il-colistin bħala l-unika sustanza attiva (EMEA/V/A/106), ilcolistin m'għadux rakkomandat għall-kura ta' infezzjonijiet gastrointestinali kkawżati mis-Salmonella spp. minħabba valutazzjoni negattiva tal-benefiċċji-riskji.
English: “However, severe nosocomial infections due to multidrug-resistant (MDR) Gram-negative bacteria now account for high morbidity and mortality in man. Colistin is therefore nowadays a last resort drug in human medicine in the context of treatment of infections caused by MDR Pseudomonas aeruginosa, Acinetobacter baumannii and Enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae), for which mortality can be extremely high.”
Maltese: Għalhekk, illum il-ġurnata Colistin huwa mediċina tal-aħħar għażla fil-mediċina tal-bniedem fil-kuntest tal-kura ta' infezzjonijiet ikkawżati minn MDR Pseudomonas aeruginosa, Acinetobacter baumannii u Enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae), li għalihom il-mortalità tista' tkun għolja ħafna."
English: No specific clinical studies were provided for invasive E. coli secondary to gastrointestinal disease.
Maltese: Ma kien ipprovdut l-ebda studju kliniku speċifiku għal E. coli invażiva b'riżultat ta' mard gastrointestinali.
English: With the renewed use of colistin use in human medicine, particularly as a last-resort therapeutic option to treat infections due to multidrugresistant (MDR), extensively drug-resistant (XDR) and pandrug-resistant (PDR), lactose-fermenting and non-fermenting Gram-negative bacilli, including Pseudomonas aeruginosa and Acinetobacter baumannii, then there are potential public health concerns with continued veterinary use of the substance.
Maltese: Bl-użu mġedded tal-colistin fil-mediċina umana, b'mod partikolari bħala opzjoni terapewtika tal-aħħar għażla għall-kura ta' infezzjonijiet minħabba baċilli Gram-negattivi reżistenti għal ħafna mediċini (MDR), estensivament reżistenti għall-mediċini (XDR) u reżistenti għall-mediċina pan (PDR), baċilli Gram-negattivi li jiffermentaw u li ma jiffermentawx illattożju, inklużi l-Pseudomonas aeruginosa u l-Acinetobacter baumannii, hemm tħassib potenzjali għas-saħħa pubblika bl-użu veterinarju kontinwat tas-sustanza.
English: Gyógyszergyártó Kft. Ottó u. 14
Maltese: Ottó u. 14
English: Drwalewskie Zakłady Przemysłu
Maltese: L-Ungerija Lavet Gyógyszergyártó
English: These additional clinical needs can include a broader spectrum of antimicrobial coverage in the body to either extend antimicrobial coverage to the rest of the body as well as the gastrointestinal tract (e.g. gastrointestinal infection plus septicaemia), or extra antimicrobial coverage within the gastrointestinal tract due to extenuating circumstances (e.g. antimicrobial resistance or polymicrobial infections).
Maltese: Dawn il-ħtiġijiet kliniċi addizzjonali jistgħu jinkludu spettru aktar wiesa' ta' kopertura antimikrobika fil-ġisem sabiex jew jestendi l-kopertura antimikrobika għall-bqija tal-ġisem kif ukoll l-apparat gastrointestinali (eż. infezzjoni gastrointestinali flimkien ma' settiċemija), jew kopertura antimikrobika addizzjonali flapparat gastrointestinali minħabba ċirkustanzi estenwanti (eż. reżistenza antimikrobika jew infezzjonijiet polimikrobiċi).
English: There are also products available for parenteral, intramammary and intrauterine administration, which are not within the scope of this referral.
Maltese: Hemm ukoll prodotti disponibbli għal amministrazzjoni parenterali, intramammarju u ġol-utru, li ma jaqgħux fil-kamp ta' applikazzjoni ta' dan ir-riferiment.
English: While in cases involving other substances used in veterinary medicine there were still therapeutic options for human medicine, in this case any potential food-chain related contributions to colistin resistance in human medicine would lead to no therapeutic options for human infections against MDR, XDR and PDR bacteria.
Maltese: Filwaqt li f'każijiet li jinvolvu sustanzi oħra użati fil-mediċina veterinarja xorta kien hemm opzjonijiet terapewtiċi għall-mediċina umana, f'dan il-każ kwalunkwe kontribut potenzjali relatat mal-katina alimentari għar-reżistenza għall-colistin fil-mediċina umana jwassal għall-ebda opzjoni terapewtika għall-infezzjonijiet tal-bniedem kontra batterji MDR, XDR u PDR.
English: Thus, colistin has re-emerged as a last-resort therapeutic option to treat infections due to MDR, XDR and PDR, lactose-fermenting and non-fermenting Gram-negative bacilli, including Pseudomonas aeruginosa and Acinetobacter baumannii.
Maltese: MDR, XDR u PDR, baċilli Gram-negattivi li jiffermentaw u li ma jiffermentawx il-lattożju, inklużi l-Pseudomonas aeruginosa u l-Acinetobacter baumannii.
English: In vitro antimicrobial synergy was identified by several MAHs and backed up by scientific publications, based on both a reduction of the MIC for target pathogens in the presence of the colistin combination and a reduction in the fractional inhibitory concentration index.
Maltese: Is-sinerġija antimikrobika in vitro kienet identifikata minn diversi detenturi tal-awtorizzazzjoni għattqegħid fis-suq u appoġġata minn pubblikazzjonijiet xjentifiċi, ibbażata kemm fuq tnaqqis tal-MIC għall-patoġeni fil-mira fil-preżenza tal-kombinazzjoni tal-colistin kif ukoll tnaqqis fl-indiċi talkonċentrazzjoni inibitorja frazzjonali.
English: The same conclusion was reached in the recent Article 35 referral procedure on oral colistin monotherapy products.
Maltese: Il-proċedura ta' riferiment riċenti skont l-Artikolu 35 dwar prodotti ta' monoterapija b'colistin orali waslet għall-istess konklużjoni.
English: Historically, this instability of polymyxin resistance, and the absence of horizontal gene transfer of these mutations, was thought to reduce the risk of rapid spread of resistance to colistin
Maltese: Storikament, din l-instabilità tar-reżistenza għallpolimiksini, u n-nuqqas ta' trasferiment orizzontali tal-ġeni ta' dawn il-mutazzjonijiet, kien maħsub li jnaqqas ir-riskju tat-tixrid rapidu tar-reżistenza għall-colistin