FrancophonIA/ELRC3.0 huggingface dataset:
English: The risk identified by maintaining this indication is that it promotes the treatment of an unknown clinical disease, leading to treatment failures because the true cause (e.g. viral, other bacteria, protozoans, parasites) is unaffected by colistin combination treatments.
Maltese: Ir-riskju identifikat biż-żamma ta' din l-indikazzjoni huwa li din tippromwovi l-kura ta' marda klinika mhux magħrufa, li jwassal għal fallimenti tal-kura minħabba li l-kawża vera (eż. virali, batterji oħra, protozoans, parassiti) ma tiġix affettwata mill-kuri ta' kombinazzjoni tal-colistin ma' antimikrobiċi oħra.
English: Veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally to food-producing species represent commonly used antimicrobials in veterinary medicine.
Maltese: Il-prodotti mediċinali veterinarji li fihom il-colistin flimkien ma' sustanzi antimikrobiċi oħra li għandhom jiġu amministrati b'mod orali lil speċi li jipproduċu l-ikel jirrappreżentaw antimikrobiċi użati b'mod komuni fil-mediċina veterinarja.
English: • the CVMP concluded that the benefit-risk assessment for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally is negative and that the products could pose a potential risk to human health;
Maltese: • is-CVMP ikkonkluda li l-valutazzjoni tal-benefiċċji u r-riskji għall-prodotti mediċinali veterinarji kollha li fihom colistin f'kombinazzjoni ma' sustanzi antimikrobiċi oħra li għandhom jiġu amministrati b'mod orali hija negattiva u li l-prodotti jistgħu jippreżentaw riskju potenzjali għassaħħa tal-bniedem;
English: This was supported by a recent EU commissioned ad hoc expert group on antimicrobial resistance (AMEG) as well as a recent Article 35 referral procedure on veterinary medicinal products containing colistin as sole active substance to be administered orally.
Maltese: Dan kien appoġġat minn grupp ad hoc riċenti ta' esperti kkummissjonat mill-UE dwar ir-reżistenza antimikrobika (AMEG) kif ukoll proċedura ta' riferiment riċenti skont l-Artikolu 35 dwar prodotti mediċinali veterinarji li fihom il-colistin bħala lunika sustanza attiva li għandha tiġi amministrata b'mod orali.
English: In the above mentioned Article 35 referral procedure (EMEA/V/A/106) for all veterinary medicinal products containing colistin as sole active substance for oral administration to food-producing species, the CVMP reached certain conclusions (described below) on some indications, dosages and target species, which would also apply to colistin combination products.
Maltese: Fil proċedura ta' riferiment skont l-Artikolu 35 imsemmija hawn fuq (EMEA/V/A/106) għall-prodotti mediċinali veterinarji kollha li fihom il-colistin bħala l-unika sustanza attiva għall-amministrazzjoni orali lil speċi li jipproduċu l-ikel, is-CVMP wasal għal ċerti konklużjonijiet (deskritti hawn taħt) dwar xi indikazzjonijiet, dożi u speċi fil-mira, li japplikaw ukoll għall-prodotti ta' kombinazzjoni tal-colistin ma' antimikrobiċi oħra.
English: Having considered all data submitted in writing, the CVMP concluded that the benefit-risk balance for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally to food-producing species is negative, due to a lack of clinical relevance and in view of over-exposure of colistin that could pose a potential risk to animal and human health from an acceleration of the occurrence of colistin resistance.
Maltese: Wara li kkunsidra d-data kollha ppreżentata bil-miktub, is-CVMP ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju għall-prodotti mediċinali veterinarji kollha li fihom colistin f'kombinazzjoni ma' sustanzi antimikrobiċi oħra li għandhom jiġu amministrati b'mod orali lil speċi li jipproduċu l-ikel huwa negattiv, minħabba nuqqas ta' rilevanza klinika u fid-dawl ta' esponiment eċċessiv għall-colistin li jista' joħloq riskju potenzjali għas-saħħa tal-annimali u tal-bniedem minħabba aċċellerazzjoni tas-seħħ tarreżistenza għall-colistin.
English: Pig
Maltese: MIU
English: In veterinary medicine, it is used typically as the sulphate salt for oral preparations and as the methanesulphonate for parenteral administration.
Maltese: Fil-mediċina veterinarja, ġeneralment jintuża bħala l-melħ tassulfat għal preparazzjonijiet orali u bħala l-metansulfonat għal amministrazzjoni parenterali.
English: However, it is important to note that stable resistance at the subclinical level (heteroresistance) can remain undetected by conventional culture/sensitivity techniques
Maltese: Madankollu, importanti li jiġi nnotat li rreżistenza stabbli fil-livell subkliniku (eteroreżistenza) tista' tibqa' ma tinstabx bit-tekniki konvenzjonali tal-kultura/sensittività
English: Considering the significant number of products containing colistin authorised in the EU it was considered appropriate to follow a stepwise approach based on risk for the revision of summary of the product characteristics of products containing colistin.
Maltese: Minħabba n-numru sinifikanti ta' prodotti li fihom il-colistin awtorizzati fl-UE, tqies xieraq li jiġi segwit approċċ gradwali bbażat fuq ir-riskju għar-reviżjoni tas-sommarju tal-karatteristiċi tal-prodott għallprodotti li fihom il-colistin.
English: Colistin has been used since the 1950s both in human and veterinary medicine
Maltese: Il-colistin ilu jintuża min-1950s kemm fil-mediċina umana kif ukoll fil-mediċina veterinarja
English: Lamb, goat, rabbits, pigs, calves, poultry
Maltese: Għoġġiela, ħrief, gidjien, moħor, qżieqeż, tjur u fniek.
English: Chicken, turkeys
Maltese: Ħnieżer, fniek
English: Regarding combinations of colistin with other antimicrobials the advice indicates that “The marketing authorisations for these products should be reviewed and unless sound justification can be provided that the combination is in line with responsible use principles, combination products should be withdrawn.”
Maltese: Dwar kombinazzjonijiet ta' colistin ma' antimikrobiċi oħra, il-parir jindika li “L-awtorizzazzjonijiet għattqegħid fis-suq għal dawn il-prodotti għandhom jiġu riveduti u sakemm ma tkunx tista' tiġi pprovduta ġustifikazzjoni soda li l-kombinazzjoni hija konformi mal-prinċipji ta' użu responsabbli, il-prodotti ta' kombinazzjoni għandhom jiġu rtirati.”
English: Oral powder
Maltese: Użu orali
English: Lamb, goat, calve
Maltese: Ifrat, tiġieġ, ħnieżer
English: Pharmacotherapy 30:1279-91.
Maltese: Resurgence of colistin: a review of resistance, toxicity, pharmacodynamics, and dosing. Pharmacotherapy 30:1279-91.
English: Lamb, goat, piglets, foals, calves
Maltese: Tiġieġ brojler, ħnieżer, fniek, għoġġiela
English: In conclusion, colistin combination products are intended to address different clinical needs to monotherapy products.
Maltese: Bħala konklużjoni, il-prodotti ta' kombinazzjoni tal-colistin ma' antimikrobiċi oħra huma maħsuba sabiex jindirizzaw ħtiġijiet kliniċi differenti għall-prodotti ta' monoterapija.
English: Based on the information provided by MAHs, including proprietary data, scientific references and expert reports, a possible risk mitigation measure considered in this Article 35 referral was to further limit the use of colistin combination products to treatment of individual animals only and remove presentations of products intended for group treatment.
Maltese: Fuq il-bażi tal-informazzjoni pprovduta mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq, li tinkludi data proprjetarja, referenzi xjentifiċi u rapporti ta' esperti, miżura possibbli ta' mitigazzjoni tarriskju kkunsidrata f'dan ir-riferiment skont l-Artikolu 35 kienet li l-użu tal-prodotti ta' kombinazzjoni tal-colistin ma' antimikrobiċi oħra jiġi limitat ulterjorment għall-kura ta' annimali individwali biss u jitneħħew il-preżentazzjonijiet ta' prodotti maħsuba għall-kura ta' gruppi.
English: In addition, the MAHs were asked to justify the benefits of using a colistin combination product over the use of monotherapy for the treatment of the respective conditions, particularly taking into account the CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005).
Maltese: Barra minn hekk, id-detenturi tal-awtorizzazzjoni għat-tqegħid fissuq kienu mitluba jiġġustifikaw il-benefiċċji tal-użu ta' prodott ta' kombinazzjoni tal-colistin ma' antimikrobiċi oħra fuq l-użu ta' monoterapija għall-kura tal-kundizzjonijiet rispettivi, b'mod partikolari fid-dawl tal-linja gwida tas-CVMP dwar prodotti farmaċewtiċi ta' kombinazzjoni fissa (EMEA/CVMP/83804/2005).
English: Currently the status for relevant Gram-negative gastrointestinal pathogens (e.g. E. coli) in the EU is that MICs of colistin are very low and colistin colonic concentrations are very high (e.g. 20 times above the MIC) such that a monotherapy product will suffice for these indications.
Maltese: Gram-negattivi rilevanti (eż. l-E. coli) fl-UE huwa li l-MICs tal-colistin huma baxxi ħafna u l-konċentrazzjonijiet tal-colistin filkolon huma għoljin ħafna (eż. 20 darba ogħla mill-MIC) tant li prodott ta' monoterapija jkun biżżejjed għal dawn l-indikazzjonijiet.
English: Also, the clinical relevance of synergy with colistin combinations is highly doubtful for the reason that colonic concentrations of colistin alone are so much higher than the MIC (e.g. 20 times more than the MIC) for E. coli and other bacteria, as a monotherapy, hence there is no clinical added value for an in vitro synergy of colistin combinations.
Maltese: Barra minn hekk, ir-rilevanza klinika tas-sinerġija b'kombinazzjonijiet tal-colistin ma' antimikrobiċi oħra hija dubjuża ħafna minħabba li lkonċentrazzjonijiet tal-colistin waħdu fil-kolon huma ferm ogħla mill-MIC (eż. 20 darba aktar mill-MIC) għall-E. coli u batterji oħra, bħala monoterapija, u għalhekk ma hemm l-ebda valur miżjud kliniku għal sinerġija in vitro tal-kombinazzjonijiet tal-colistin ma' antimikrobiċi oħra.
English: Lithuania Lavet Pharmaceuticals Ltd. Ottó u. 14.
Maltese: Il-Litwanja Lavet Pharmaceuticals
English: Lamb, calves Oral use
Maltese: Amministrazzjoni orali, wara inkorporazzjoni flgħalf
English: • the CVMP considered that no convincing data were provided by the MAHs, in terms of clinical trials or other scientifically acceptable studies, as to clinical scenarios where colistin combination products are essential for food-producing animals in the EU compared to monotherapy products;
Maltese: • is-CVMP qies li ma kienet ipprovduta l-ebda data konvinċenti mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq, f'termini ta' provi kliniċi jew studji oħra xjentifikament aċċettabbli, dwar ixxenarji kliniċi fejn huma essenzjali prodotti ta' kombinazzjoni tal-colistin ma' antimikrobiċi oħra għall-annimali li jipproduċu l-ikel fl-UE meta mqabbel ma' prodotti ta' monoterapija;
English: Animal species
Maltese: Pharmaceuticals
English: The broad-spectrum activity of colistin against Gram-negative bacteria involves binding to lipid A, the anchor for lipopolysaccharide and the main constituent of the outer membrane of many bacteria
Maltese: L-attività bi spettru wiesa' tal-colistin kontra batterji Gram-negattivi tinvolvi t-twaħħil mal-lipidu A, l-ankra għal-lipopolisakkarida u l-kostitwent prinċipali tal-membrana esterna ta' bosta batterji
English: In view of the concerns above and in line with the aforementioned recommendations from the EMA/CVMP/CHMP scientific advice to the European Commission, as a second step, the Committee was requested to review the marketing authorisations of all veterinary medicinal products containing colistin in combination with other antimicrobial substances for oral administration to food-producing species in order to ensure responsible use of the substance in protecting animal health and limiting the possibility of future risk to public health.
Maltese: F'din il-proċedura s-CVMP kien mitlub jeżamina l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali veterinarji kollha li fihom colistin f'kombinazzjoni ma' sustanzi antimikrobiċi oħra għallamministrazzjoni orali lil speċi li jipproduċu l-ikel sabiex ikun assigurat l-użu responsabbli tas-sustanza fil-protezzjoni tas-saħħa tal-annimali u tiġi limitata l-possibbiltà ta' riskju ġejjieni għas-saħħa pubblika.
English: Lamb, goat, calves, poultry
Maltese: Ħnieżer, għoġġiela, tjur (tiġieġ, dundjani), ħamiem
English: Proprietary data, scientific references and expert reports were provided in this Article 35 referral procedure in support of some indications of some of the products included in the scope of the procedure.
Maltese: F'din il-proċedura ta' riferiment skont l-Artikolu 35 kienu pprovduti data proprjetarja, referenzi xjentifiċi u rapporti ta' esperti b'appoġġ għal xi indikazzjonijiet ta' xi wħud mill-prodotti inklużi fil-kamp ta' applikazzjoni ta' din il-proċedura.
English: Petőfi u. 9.
Maltese: Ottó u. 14.
English: Colibacillosis is defined as an infection of the colon by Enterobacteriaceae, especially E. coli, resulting in a disease manifestation, typically diarrhoea and other manifestations in poultry.
Maltese: Il-kolibaċillożi hija definita bħala infezzjoni tal-kolon bl-Enterobacteriaceae, speċjalment l-E. coli, li tirriżulta f'manifestazzjoni ta' mard, ġeneralment dijarea u manifestazzjonijiet oħra fit-tjur.
English: programmes and thus compromises public health and food safety.
Maltese: u b'hekk jikkomprometti s-saħħa pubblika u s-sigurtà fl-ikel.
English: Concurrent E. coli related gastrointestinal diseases (e.g. septicaemia) were identified by MAHs as occurring as complications from the original gastrointestinal disease through either direct systemic spread or immunosuppression.
Maltese: Mard gastrointestinali simultanju relatat mal-E. coli (eż. settiċemija) kien identifikat mid-detenturi talawtorizzazzjoni għat-tqegħid fis-suq bħala li jseħħ bħala kumplikazzjonijiet mill-marda gastrointestinali oriġinali jew permezz ta' tixrid sistemiku dirett jew permezz ta' immunosoppressjoni.
English: A substantial change has occurred over the last five years regarding the importance of colistin in human and veterinary medicine - from a molecule used only in veterinary medicine, colistin has become a critically important molecule in human medicine.
Maltese: Matul dawn l-aħħar ħames snin seħħet bidla sostanzjali rigward l-importanza tal-colistin fil-mediċina umana u dik veterinarja - minn molekula użata biss fil-mediċina veterinarja, il-colistin sar molekula kritikament importanti fil-mediċina umana.
English: The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report.
Maltese: Is-CHMP, wara li kkunsidra l-applikazzjoni huwa tal-fehma li l-bilanċbejn ir-riskju u l-benefiċċju huwa wieħed favorevoli biex jirrakkomanda l-għoti tal-awtorizzazzjoni għat-tqegħid fis-suq taħt kondizzjonijiet eċċezzjonali kif spjegat aktar fir-Rapport Pubbliku Ewropew ta' Valutazzjoni.
English: Annex IV Conclusions on the granting of the conditional marketing authorisation and presented by the European Medicines Agency
Maltese: ANNESS IV Konklużjonijiet dwar l-għoti tal-awtorizzazzjoni għat-tqegħid fissuq kondizzjonali ppreżentati mill-aġenzija ewropea għall-mediċni
English: Conclusions presented by the European Medicines Agency on: • Conditional marketing authorisation
Maltese: Konklużjonijiet imressqa mill-Aġenzija Ewropea għall-Mediċini dwar:
English: and Proteus mirabilis.
Maltese: u Proteus mirabilis.
English: mg administered
Maltese: mg amministrati
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
English: Intervet GesmbH Siemensstrasse 107 A-1210 Wien Austria
Maltese: Intervet GesmbH Siemensstrasse 107 A-1210
English: Antagonism may be observed with nitrofurantoin.
Maltese: Jista' jkun hemm antagoniżmu ma' nitrofurantoin.
English: Methyl parahydroxybenzoate (0.125%) Potassium dihydrogen phophate Disodium hydrogen phosphate dihydrate Carbomer (carbopol 974 PNF) Sodium hydroxide solution Water for injections
Maltese: Methyl parahydroxybenzoate (0.125%) Potassium dihydrogen phophate Disodium hydrogen phosphate dihydrate Carbomer (carbopol 974 PNF) Soluzzjoni ta' sodium hydroxide Ilma għall-injezzjonijiet
English: and Salmonella spp.
Maltese: u Salmonella spp.
English: IBAFLIN TABLETS 30, 150, 300 AND 900 MG
Maltese: IBAFLIN PILLOLI 30, 150, 30 U 900
English: 20 tablets / 100 tablets 10 tablets / 20 tablets / 100 tablets 8 tablets /16 tablets / 80 tablets 5 tablets /25 tablets / 50 tablets
Maltese: 20 pillola / 100 pillola 10 pilloli / 20 pillola / 100 pillola 8 pilloli / 16-il pillola / 80 pillola 5 pilloli / 25 pillola / 50 pillola
English: 20 or 100 tablets 10, 20 or 100 tablets 8, 16 or 80 tablets 5, 25 or 50 tablets
Maltese: 20 jew 100 pillola 10, 20 jew 100 pillola 8, 16 jew 80 pillola 5, 25 jew 50 pillola
English: and Pasteurella spp.
Maltese: u Pasteurella spp.
English: - carton box with 1 x 15 ml (0.5 ml steps) pre-filled syringe (Ibaflin 3% Oral Gel) - carton box with 5 x 15 ml (0.5 ml steps) pre-filled syringes (Ibaflin 3% Oral Gel) - carton box with 1 x 30 ml (1 ml steps) pre-filled syringe (Ibaflin 7.5% Oral Gel) - carton box with 5 x 30 ml (1 ml steps) pre-filled syringes (Ibaflin 7.5% Oral Gel)
Maltese: - kaxxa tal-kartun b'1 x 15 ml (gradi ta' 0.5 ml) siringa mimlija bil-lest (Ibaflin 3% Ġell Orali) - kaxxa tal-kartun b'5 x 15 ml (gradi ta' 0.5 ml) siringi mimlijin bil-lest (Ibaflin 3% Ġell Orali) - kaxxa tal-kartun b'1 x 30 ml (gradi ta' 1 ml) siringa mimlija bil-lest (Ibaflin 7.5% Ġell Orali) - kaxxa tal-kartun b'5 x 30 ml (gradi ta' 1 ml) siringi mimlijin bil-lest (Ibaflin 7.5% Ġell Orali)
English: EXPIRY DATE (Month/year)
Maltese: DATA TA' SKADENZA (Xahar / sena)
English: Dosage (number of tablets)
Maltese: Piż (kg) Dożaġġ (numru ta' pilloli)
English: Ibaflin 7.5% Oral Gel 1 ml of gel per 5 kg body weight.
Maltese: Ibaflin 7.5% Ġell Orali 1 ml ta' ġell għal kull 5 kg piż.
English: Ibaflin 900 mg
Maltese: Ibaflin 300mg Ibaflin 900 mg
English: Terminal plasma half-life is approximately 4-5 hours.
Maltese: Half-life terminali fil-plażma huwa ta' 4-5 siegħat.
English: Terminal plasma half-life is approximately 3-5 hours.
Maltese: Half-life terminali fil-plażma huwa ta' 3-5 siegħat.
English: Pyoderma (superficial and deep), wounds, abscesses, acute uncomplicated urinary tract infections and upper respiratory tract infections.
Maltese: Pijoderma (superfiċjali u fonda), feriti, axxessi, infezzjonijiet akuti u mhux ikkumplikati tas-sistema urinarja u infezzjonijiet tas-sistema respiratorja tan-naħa ta' fuq.
English: Ibaflin 3% Oral Gel: 30 mg of ibafloxacin per g of gel (equivalent to 30.9 mg/ml); Ibaflin 7.5% Oral Gel: 75 mg of ibafloxacin per g of gel (equivalent to 78.8 mg/ml) Excipients
Maltese: Ibaflin 3% Ġell Orali: 30 mg ta' ibafloxacin għal kull g ta' ġel (ekwivalenti għal 30.9 mg/ml); Ibaflin 7.5% Ġell Orali: 75 mg ta' ibafloxacin għal kull g ta' ġel (ekwivalenti għal 78.8 mg/ml)
English: Ibafloxacin and 8-hydroxy-ibafloxacin act synergystically.
Maltese: Ibafloxacin u 8-hydroxy-ibafloxacin jaħdmu b'mod sinerġistiku.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini (EMA) http://www.ema.europa.eu/.
English: Active substance(s)
Maltese: ATTIVA(I)
English: PACKAGE INSERT FOR INCLUSION WITH THE IBAFLIN TABLETS
Maltese: FIL-PAKKETT PILLOLI IBAFLIN
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 3% oral gel
Maltese: VETERINARJU Ibaflin 3% ġell orali
English: Siemensstraße 107 1210 Vienna Austria
Maltese: Siemensstrasse 107
English: coli, Klebsiella spp.
Maltese: Staphylococci, E. coli u Klebsiella spp.
English: 15 mg per kg bodyweight = 1 ml of gel per 5 kg bodyweight
Maltese: 15 mg għal kull kg piż = 1 ml ġell għal kull 5 kg piż
English: For ibafloxacin (parent compound), MIC values ranging from 0.032 - 0.5 µg/ml are observed for canine isolates of E. coli, Staphylococcus spp., Proteus mirabilis, strains of Pasteurella spp.
Maltese: 032 - 0.5 µg/ml ġew osservati għal iżolati mill-klieb ta' E. coli, Staphylococcus spp., Proteus mirabilis, forom ta' Pasteurella spp.
English: Pharmacotherapeutic group: antibacterial quinolone ATCvet code: QJ 01 MA
Maltese: Kwalitajiet Farmakodinamiċi Grupp Farmako-terapewtiku: quinolone antibatteriku.
English: White adjustable multidose pre-filled syringe consisting of high density polyethylene (HDPE, barrel, plunger and ring) and low density polyethylene (LDPE, cap and seal).
Maltese: Siringi bojod li jistgħu jiġu aġġustati, mimlija bil-lest b'ħafna dożi, magħmula minn high density polyethylene (HDPE, stoċċ, planġer u ċurkett) u low density polyethylene (LDPE, kappa u siġill).
English: Name and address of the Marketing Authorisation Holder Intervet International B.V.
Maltese: Intervet International B.V.
English: Ibafloxacin is a synthetic antimicrobial substance of the fluoroquinolone class.
Maltese: Ibafloxacin hija sustanza sintetika kontra lmikrobi, tal-klassi tal-fluoroquinolones.
English: Lactose
Maltese: Lamtu
English: 15 mg per kg bodyweight = 0.5 ml of gel per kg bodyweight
Maltese: 15 mg għal kull kg piż = 0.5 ml ġell għal kull kg piż
English: In cats, relevant susceptible micro-organisms are E.coli, Staphylococcus spp., Pasteurella spp., Proteus spp.
Maltese: Fil-qtates, mikro-organiżmi relevanti li kienu suxxettibbli huma E. coli, Staphylococcus spp., Pasteurella spp., Proteus spp. and Klebsiella spp.
English: STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S) Ibaflin 7.5% Oral Gel: 75 mg of ibafloxacin per g of gel (equivalent to 78.8 mg/ml) Excipients
Maltese: Ibaflin 7.5% Ġell Orali: 75 mg ta' ibafloxacin għal kull g ta' ġel (ekwivalenti għal 78.8 mg/ml) Ingredjenti oħra
English: Oral Gel
Maltese: Ġell Orali
English: - Carton box with 8, 16 or 80 tablets in PVC/aluminium heat sealed blisters - Carton box with 8, 16 or 80 tablets in PVC/PVDC/aluminium blisters 900 mg tablets: - Carton box with 5, 25 or 50 tablets in PVC/aluminium heat sealed blisters.
Maltese: - Kaxxa tal-kartun bi 8, 16 jew 80 pillola fi strixxi tal- PVC/PVDC/aluminju.
English: 30 mg of ibafloxacin per tablet 150 mg of ibafloxacin per tablet 300 mg of ibafloxacin per tablet 900 mg of ibafloxacin per tablet
Maltese: 30 mg ibafloxacin f'kull pillola 150 mg ibafloxacin f'kull pillola 300 mg ibafloxacin f'kull pillola 900 mg ibafloxacin f'kull pillola
English: The gel should therefore be administered at feeding time to ensure maximal bioavailability.
Maltese: Għalkemm ikun aħjar jekk il-pillola tingħata waqt ħin l-ikel biex tiġi żgurata bioavailability massima.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 7.5% oral gel
Maltese: VETERINARJU Ibaflin 7.5% ġell orali
English: 4.9 Posology and method of administration
Maltese: .9 Doża rakkomandata u l-metodu ta' amministrazzjoni
English: Ibaflin gel contains ibafloxacin as active ingredient.
Maltese: Ibaflin ġell fih ibafloxacin bħala s-sustanza attiva.
English: B. PACKAGE INSERT
Maltese: FIL-PAKKETT
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use, 15 mg per kg bodyweight once daily.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu mill-ħalq, 15 mg għal kull kg piż darba kuljum.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Ibafloxacin
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI
English: STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S) Ibaflin 3% Oral Gel: 30 mg of ibafloxacin per g of gel (equivalent to 30.9 mg/ml); Excipients
Maltese: Ibaflin 3% Ġell Orali: 30 mg ta' ibafloxacin għal kull g ta' ġel (ekwivalenti għal 30.9 mg/ml) Ingredjenti oħra
English: Marketing Authorisation number(s) EU/2/00/022/09-12
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/00/022/09-12
English: For ibafloxacin (parent compound), MIC values ranging from 0.032 - 0.5 µg/ml are observed for canine isolates of E. coli, Staphylococcus spp.
Maltese: 032 - 0.5 µg/ml ġew osservati għal iżolati mill-klieb ta' E. coli, Staphylococcus spp.