FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 156 patients were randomised to treatment with 5-FU (800 mg/m2 per day, continuous infusion on days 1 to 5 every 3 weeks) and cisplatin (80 mg/m2 as a 2-hour infusion on day
Maltese: Total ta' 156 pazjent kienu randomised għall-kura b'5-FU (800 mg/m2 kuljum, infużjoni kontinwa fl-ewwel sal-ħames jum kull 3 ġimgħat) u cisplatin (80 mg/m2 bħala infużjoni fuq medda ta' sagħtejn fl-ewwel jum, kull
English: How to store Capecitabine SUN
Maltese: Jekk tinsa tieħu Capecitabine SUN
English: Elderly: Based on the population pharmacokinetic analysis, which included patients with a wide range of ages (27 to 86 years) and included 234 (46%) patients greater or equal to 65, age has no influence on the pharmacokinetics of 5'-DFUR and 5-FU.
Maltese: Ibbażat fuq analiżi tal-farmakokinetika tal-popolazzjoni, li kienet tinkludi pazjenti b'firxa wiesa' ta' etajiet (minn 27 sa 86 sena) u li kienet tinkludi 234 (46%) pazjent li kellhom iżjed minn 65 sena jew kellhom 65 sena, l-età m'għandha l-ebda influwenza fuq il-farmakokinetika ta' 5'-DFUR
English: Time to progressive disease was superior in the capecitabine + docetaxel combination arm (p<0.0001).
Maltese: Iż-żmien għall-progressjoni talmarda kien superjuri fil-grupp ta' kura kombinata b'capecitabine u docetaxel (p<0.
English: Colon, colorectal and gastric cancer
Maltese: Kanċer tal-kolon, tal-kolorektum u tas-sider
English: Careful monitoring of patients ≥60 years of age is advisable.
Maltese: Sorveljanza bir-reqqa ta' pazjenti li għandhom ≥ 60 sena huwa rakkomandat.
English: Patients with hepatic impairment due to liver metastases: According to a pharmacokinetic study in cancer patients with mild to moderate liver impairment due to liver metastases, the bioavailability of capecitabine and exposure to 5-FU may increase compared to patients with no liver impairment.
Maltese: Pazjenti b'indeboliment tal-fwied minħabba metastasi fil-fwied: Skont studju farmakokinetiku f'pazjenti bil-kanċer, b'indeboliment tal-fwied ħafif għal moderat minħabba metastasi fil-fwied, ilbiodisponibiltà ta' capecitabine u l-espożizzjoni għal 5-FU jistgħu jiżdiedu meta mqabbla ma' pazjenti bl-ebda indeboliment tal-fwied.
English: Capecitabine SUN 500 mg film-coated tablets are peach coloured, oval, biconvex, 17.5 mm x 8.7 mm tablets, with inscription ‘500'on one side and plain on other side.
Maltese: 5 mm x 8.7 mm, bil-marka ‘500' fuq naħa waħda u lixxi fuq in-naħa l oħra.
English: Given as monotherapy, the recommended starting dose for capecitabine in the adjuvant treatment of colon cancer, in the treatment of metastatic colorectal cancer or of locally advanced or metastatic breast cancer is 1250 mg/m2 administered twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 14 days followed by a 7-day rest period.
Maltese: Mogħti bħala monoterapija, d-doża rakkomandata tal-bidu ta' capecitabine fil-kura awżiljarja talkanċer tal-kolon, fil-kura ta' kanċer tal-kolorektum li mmetastatizza jew ta' kanċer tas-sider lokalment avvanzat jew li mmetastatizza hija ta' 1250 mg/m2 mogħtija darbtejn kuljum (fil-għodu u fil-għaxija;
English: Rash, Alopecia, Erythema, Dry skin, Pruritus, Skin hyperpigmentation, Rash macular, Skin desquamation, Dermatitis, Pigmentation disorder, Nail disorder
Maltese: Raxx makulari, Tqaxxir tal-ġilda, Dermatite, Disturbi filpigmentazzjoni, Disturbi fid-dwiefer
English: Renal impairment.
Maltese: huwa rakkomandat.
English: Administration with food decreases the rate of capecitabine absorption (see section 5.2).
Maltese: L-għoti ma' l-ikel inaqqas ir-rata ta' l-assorbiment ta' capecitabine (ara sezzjoni 5.2).
English: Capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen (see section 5.1).
Maltese: Capecitabine huwa indikat bħala kura primarja ta' kanċer avvanzat fl-istonku f'taħlita ma' programm ta' kura ibbażat fuq il-platinu (ara sezzjoni 5.1).
English: Package leaflet: Information for the user Capecitabine SUN 150 mg film-coated tablets capecitabine
Maltese: Informazzjoni għall-utent Capecitabine SUN 150 mg pilloli miksija b'rita capecitabine
English: - Steven-Johnson syndrome: if you experience painful red or purplish rash that spreads and blisters and/or other lesions begin to appear in the mucous membrane (e.g. mouth and lips), in particular if you had before light sensitivity, infections of the respiratory system (e.g. bronchitis) and/or fever.
Maltese: - Sindrome ta' Steven-Johnson: jekk ikollok raxx juġgħa ta' lewn aħmar jew jagħti fil-vjola li jinfirex u nfafet u/jew leżjonijiet oħra jibdew jidhru fil-membrani mukużi (eż. ħalq u xufftejn), b'mod partikolari jekk qabel kellek sensittività għad-dawl, infezzjonijiet tas-sistema respiratorju (eż. bronkite) u/jew deni.
English: Rarely, unexpected, severe toxicity (e.g. stomatitis, diarrhoea, neutropenia and neurotoxicity) associated with 5-FU has been attributed to a deficiency of DPD activity.
Maltese: B'mod rari, tossiċità severa, mhux mistennija, (eż. stomatite, dijarea, newtropenija u newrotossiċità) assoċjati ma' 5-FU kienet attribwita għal nuqqas ta' attività ta' DPD. Għalhekk rabta ma' livelli mnaqqsa ta' DPD u żieda li tista' tkun fatali ta' effetti tossiċi ta' 5-FU ma tistgħax tiġi eskluża.
English: Furthermore, the Committee noted that alternative treatments are available.
Maltese: Barra minn hekk jeżistu trattamenti alternattivi.
English: The CHMP discussed the matter at its November 2007 plenary meeting and the procedure in accordance with Article 107(2) of Directive 2001/83/EC, as amended was started.
Maltese: Is-CHMP iddiskuta din il-materja fil-laqgħa plenarja tiegħu ta' Novembru 2007 u nbdiet proċedura skond l-Artikolu 107(2) tad-Direttiva 2001/83/KE, kif emendata.
English: It is acknowledged that lumiracoxib 100 mg once daily offers a gastrointestinal safety advantage compared with naproxen 1000 mg and ibuprofen 2400 mg.
Maltese: Huwa rikonoxxut li lumiracoxib tal-100 mg darba kuljum joffri vantaġġ minħabba sigurtà gastrointestinali meta mqabbel ma' naproxen ta' l-1000 mg u ibuprofen ta' l-2400 mg.
English: Lumiracoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the group of the selective cyclooxygenase-2 (COX-2) inhibitors indicated for symptomatic relief in the treatment of osteoarthritis of the knee and hip.
Maltese: Lumiracoxib huwa mediċina anti infjammatorja mhux sterojde (NSAID) li jagħmel parti mill-grupp ta' inibituri selettivi ta' cyclooxygenase-2 (COX-2) indikati għas-serħan simtomatiku fit-trattament ta' l-ostjoartrite ta' l-irkobba u tal-ġenbejn.
English: They are available under the invented names Frexocel, Hirzia, Prexige and Stellige as film coated tablets for oral administration.
Maltese: Jiġu taħt l-ismijiet ivvintati Frexocel, Hirzia, Prexige u Stellige bħala pilloli miksijin b'rita għall-amministrazzjoni orali.
English: Furthermore, a number of spontaneous reports of hepatic disorders associated with use of lumiracoxib (up to 15 November 2007, in total 181) have been received, including 74 reports which were judged to be related to lumiracoxib, and to be serious.
Maltese: Barra minn hekk, waslu għadd ta' rapporti spontanji ta' problemi fil-fwied ma' l-użu ta' lumiracoxib (sal-15 ta' Novembru ta' l2007, b'kollox waslu 181), fosthom 74 rapport li ġew iġġudikati li huma relatati ma' lumiracoxib, u li huma serji.
English: It is not possible to reliably estimate the magnitude of the risk based on spontaneous reporting rates.
Maltese: Mhuwiex possibbli li ssir stima affidabbli dwar il-kobor tar-riskju abbażi tar-rati ta' rapporti spontanji.
English: Although the majority of these events were reported for 200 or 400 mg, there have been reports also for the 100 mg dose, which is the dose approved in the EU.
Maltese: Għalkemm il-maġġoranza ta' dawn l-avvenimenti ġew irrappurtati għal dożi ta' 200 jew 400 mg, kien hemm rapporti wkoll għad-doża ta' 100 mg, li hija d-doża approvata fl-UE.
English: The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing lumiracoxib at the 100 mg dose.
Maltese: Il-Kumitat ikkunsidra l-proċedura taħt l-Artikolu 107 tad-Direttiva 2001/83/KE, kif emendata, għal prodotti mediċinali li fihom lumiracoxib f'doża ta' 100 mg.
English: However, there are alternatives with a comparable gastrointestinal safety profile including other COX-2 inhibitors or NSAID given together with gastroprotection.
Maltese: Lumiracoxib wera vantaġġ gastrointestinali meta mqabbel ma' dożi għoljin ta' NSAIDs. Madankollu hemm alternattivi bi profil tas-sigurtà gastrointestinali komparabbli inklużi inibituri ta' COX-2 jew NSAID oħra mogħtija flimkien mal-protezzjoni gastrointestinali.
English: Medicinal products containing 100 mg lumiracoxib were authorised in the United Kingdom (UK) in 2003 and are authorised in a number of EU Member States via mutual recognition (see Annex I for the list of lumiracoxib containing medicinal products authorised in the EU).
Maltese: Prodotti mediċinali li jkun fihom 100 mg lumiracoxib kienu awtorizzati fir-Renju Unit fl-2003 u huma awtorizzati f'numru ta' Stati Membri permezz ta' rikonoxximent reċiproku (ara l-Anness I għal-lista ta' prodotti mediċinali li jkun fihom lumiracoxib fl-UE).
English: On 9 November 2007, the United Kingdom Competent Authority (MHRA) issued a Rapid Alert informing the Member States, the EMEA and the European Commission in accordance with Article 107 of Directive 2001/83/EC, as amended, of the intention to suspend the Marketing Authorisations for lumiracoxib containing medicinal products in its Member State.
Maltese: Fid-9 ta' Novembru ta' l-2007, l-Awtorità Kompetenti tar-Renju Unit (MHRA) ħarġet Allarm Malajr li jgħarraf lill-Istati Membri, lill-EMEA u lill-Kummissjoni Ewropea skond l-Artikolu 107 tadDirettiva 2001/83/KE, kif emendata, bl-intenzjoni li tissospendi l-Awtorizzazzjonijiet għat-Tqegħid fis-Suq għal prodotti mediċinali li jkun fihom lumiracoxib fir-Renju Unit.
English: There is evidence from clinical trials that lumiracoxib is associated with a higher risk for hepatic adverse reactions compared with naproxen, ibuprofen and celecoxib.
Maltese: Hemm evidenza mill-istudji kliniċi li lumiracoxib huwa assoċjat ma' riskju ikbar għal reazzjonijiet ħżiena fil-fwied meta mqabbel ma' naproxen, ibuprofen u celecoxib.
English: Following the provisions under Article 107 (2) of Directive 2001/83/EC, as amended, the Agency's Committee for Medicinal Products for Human Use (CHMP) prepared an Opinion on 13 December 2007 recommending the revocation of the Marketing Authorisations for all lumiracoxib containing medicinal products in Annex I. The CHMP also recommended that temporary measures are needed in order to protect public health and therefore recommends to the European Commission that the marketing and the use of lumiracoxib containing medicinal products be suspended forthwith in all concerned EU Member States awaiting the adoption of final measures.
Maltese: Skond id-dispożizzjonijiet ta' l-Artikolu 107 (2) tad-Direttiva 2001/83/KE, kif emendata, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ta' l-Aġenzija ħejja Opinjoni fit-13 ta' Diċembru ta' l-2007 u fiha rrakkomanda r-revoka ta' l-Awtorizzazzjonijiet għat-Tqegħid fis-Suq għall-prodotti mediċinali li fihom lumiracoxib fl-Anness I.
English: The proposed risk minimisation measures are neither considered to assure adequate patient safety, nor to be realistic given the approved clinical indication.
Maltese: Il-kumitat ikkunsidra li l-miżuri ta' tnaqqis tar-riskju proposti ma jistgħux jiżguraw sigurtà adegwata għall-pazjent, u li dawn m'humiex meqjusa realistiċi meta wieħed iqis l-indikazzjoni klinika.
English: The available data (clinical trial results and spontaneous reporting) suggest a dose and possibly duration dependant effect, although some cases (even at the 100 mg dose) were observed after short duration of treatment.
Maltese: Id-dejta disponibbli (riżultati minn studji kliniċi u rapporti spontanji) tissuġġerixxi li l-effett jiddependi middoża u possibbilment mit-tul tat-trattament, għalkemm ġew osservati xi każi anke f'doża ta' 100 mg wara trattament fil-qosor.
English: The Committee concluded that there is increasing evidence for lumiracoxib-associated risk of hepatotoxicity at the 100 mg dose, and in some cases a short time to onset cannot be excluded.
Maltese: Il-kumitat ikkonkluda li hemm evidenza li qed tiżdied għar-riskju ta' tossiċità tal-fwied assoċjata ma' lumiracoxib f'doża ta' 100 mg, u f'xi każi ma jistax jiġi eskluż ħin qasir għall-bidu ta' l-azzjoni.
English: In its assessment the MHRA concluded that lumiracoxib at the 100 mg dose was associated with an increased risk of hepatotoxicity.
Maltese: Fil-valutazzjoni tagħha, lEMEA ikkonkludiet li lumiracoxib fid-doża ta' 100 mg huwa assoċjat ma' żieda fir-riskju ta' tossiċità fil-fwied.
English: An increased risk for serious hepatotoxic adverse drug reactions has been identified with lumiracoxib, for which an early onset cannot be excluded.
Maltese: Ma' lumiracoxib ġiet identifikata żieda fir-riskju għal reazzjonijiet tossiċi serji fil-fwied, li għalihom ma jistax jiġi eskluż bidu bikri ta' l-azzjoni.
English: Lumiracoxib is indicated in the treatment of osteoarthritis of the knee and hip, which is a chronic, but not life-threatening disease, where long-term treatment is usually needed.
Maltese: Lumiracoxib huwa indikat fit-trattament ta' l-ostjoartrite ta' l-irkobba u tal-ġenbejn, li hija marda kronika iżda li ma tqegħidx lill-persuna fil-periklu tal-mewt, u li ġeneralment, fiha jkun hemm bżonn trattament fit-tul.
English: However, such short treatment duration is not compatible with the effective management of a chronic disease (osteoarthritis of the knee and hip), and taking the characteristics of the disease into account, readministration of lumiracoxib would be necessary.
Maltese: Madankollu, trattament hekk fil-qosor mhuwiex kompatibbli mal-ġestjoni effettiva ta' mard kroniku (l-ostjoartrite ta' l-irkobba u talġenbejn) u meta wieħed iqis il-karatteristiċi tal-marda, ikun jeħtieġ li lumiracoxib jingħata mill-ġdid.
English: Additional risk minimisation measures proposed by the marketing authorisation holder included a restriction of pack size to 2 weeks of treatment, the implementation of a treatment registry, and a long-term epidemiological cohort study.
Maltese: Miżuri oħra għat-tnaqqis tar-riskju proposti mid-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq jinkludu tnaqqis fid-daqs tal-pakkett għal ġimagħtejn trattament, l-implimentazzjoni ta' reġistru tattrattament, u studju epidemjoloġiku fit-tul ta' grupp ta' nies.
English: To conclude, the present and newly proposed restrictions are not considered sufficiently reassuring to prevent the risk for adverse hepatic reactions such as the ones which have been reported spontaneously.
Maltese: Fl-aħħar, ir-restrizzjonijiet attwali u proposti riċentament m'humiex meqjusa biżżejjed biex ikun żgurat li jitneħħew ir-riskji ta' reazzjonijiet negattivi fil-fwied bħal dawk li ġew rappurtati spontanjament.
English: GROUNDS FOR THE REVOCATION OF THE MARKETING AUTHORISATIONS
Maltese: SOMMARU GLOBALI TA' L-EVALWAZZJONI XJENTIFIKA TA' PRODOTTI MEDIĊINALI
English: Several risk minimisation measures are presently in place, including a contraindication in patients with present or previous hepatic dysfunction or being treated with other hepatotoxic medicines; and recommendations for baseline and on treatment liver test monitoring.
Maltese: Bħalissa hemm ħafna miżuri għat-tnaqqis tar-riskju, fosthom kontraindikazzjoni f'pazjenti b'disfunzjoni attwali jew fl-imgħoddi fil-fwied jew li jkunu ttrattati b'mediċini oħra li jistgħu jwasslu għal tossiċità fil-fwied; u rakkomandazzjonijiet għal sorveljanza ta' l-ittestjar tal-fwied bħala linja bażi jew għat-trattament.
English: Lumiracoxib has demonstrated a gastrointestinal advantage compared with high doses of NSAIDs.
Maltese: LUMIRACOXIB (ara Anness I)
English: However, it is unknown and questionable if these advantages would be maintained if the NSAID was co-administered with a proton pump inhibitor, or in patients concomitantly taking low dose acetylsalicylic acid.
Maltese: Madankollu, mhuwiex magħruf u huwa dibattibbli jekk dawn il-vantaġġi jibqgħux hemm jekk NSAID jiġi amministrat flimkien ma' inibitur tal-pompa tal-protoni, jew f'pazjenti li jkunu qed jieħdu dożi baxxi ta' acetylsalicylic acid fl-istess ħin.
English: MA (EU) number (Invented) name Strength
Maltese: Numru tal-MA (UE) Isem (ivvintat) Qawwa
English: (including S. pseudintermedius),
Maltese: (inkluż S. pseudintermedius),
English: ATCvet code: QJ01MA97
Maltese: QJ01MA97
English: Superficial pyoderma Deep pyoderma
Maltese: Pijoderma superfiċjali Pijoderma profonda
English: Veraflox oral suspension is supplied in two different presentations:
Maltese: Veraflox sospensjoni orali jiġi f'żewġ preżentazzjonijiet differenti:
English: HR-10000 Zagreb
Maltese: HR-10000
English: Reading RG2 6AD-UK Tel: +44 (0)118 206 3000
Maltese: RG2 6AD-UK Tel: +44 (0)118 206 3000
English: PHARMACEUTICAL FORM Oral suspension.
Maltese: GĦAMLA FARMAĊEWTIKA Sospensjoni orali.
English: EU/2/10/107/001 7 tablets EU/2/10/107/002 21 tablets EU/2/10/107/003 70 tablets EU/2/10/107/004 140 tablets
Maltese: EU/2/10/107/001 7 pilloli EU/2/10/107/002 21 pillola EU/2/10/107/003 70 pillola EU/2/10/107/004 140 pillola
English: Pradofloxacin dose (mg/kg bw)
Maltese: Doża ta' Pradofloxacin (mg/kg bw)
English: - 7 tablets - 21 tablets - 70 tablets - 140 tablets
Maltese: - 7 pilloli - 21 pillola - 70 pillola - 140 pillola
English: CY-2415 Έγκωμη, Λευκωσία Τηλ: +357-22-591918
Maltese: Έγκωμη, Λευκωσία Τηλ: +357-22-591918
English: The bioavailability of the veterinary medicinal product is at least 60%.
Maltese: Il-bijodisponibilità tal-prodott mediċinali veterinarju hi tal-inqas 60%.
English: Method of administration
Maltese: U METODU TA' AMMINISTRAZZJONI
English: Excipients: Preservative: Sorbic acid (E200)
Maltese: Sorbic acid (E200)
English: Magyarország Bayer Hungária Kft. HU-1123 Budapest Alkotás u. 50
Maltese: HU-1123 Budapest Alkotás u. 50
English: BE-1831 Diegem (Machelen)
Maltese: BE-1831 Diegem (Machelen) Tel/Tél:
English: The bioavailability of the tablet is at least 70%.
Maltese: Il-bijodisponibilità talpillola hija tal-inqas 70%.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12/04/2011
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 12/04/2011
English: Amberlite IRP 64 Sorbic acid Ascorbic acid Xanthan gum Propylene glycol Vanilla flavour Purified water
Maltese: Sorbic acid Ascorbic acid Xanthan gum Propylene glycol Vanilla flavour Ilma ppurifikat
English: Pharmacotherapeutic group: Antibacterials for systemic use, fluoroquinolones.
Maltese: Antibatterji għal użu sistemiku, fluoroquinlones.
English: 7 tablets 21 tablets 70 tablets 140 tablets
Maltese: 7 pilloli 21 pillola 70 pillola 140 pillola
English: (see section “Special Warnings”).
Maltese: (ara sezzjoni “Twissijiet speċjali”).
English: Animal Health Drammensveien 288 NO-0283 Oslo Tlf: +47 23130500
Maltese: Animal Health Drammensveien 147 B NO-0277 Oslo Tlf: +47 24 11 18 00
English: MIC range (µg/ml)
Maltese: Medda ta' MIC (µg/ml)
English: Intermittent vomiting was observed after repeated oral administration of 1.6 times the maximum recommended dose.
Maltese: Ġie osservat rimettar kull tant żmien wara amministrazzjoni orali ripetuta ta' 1.6 drabi d-doża massima rakkomandata.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Pradofloxacin 25 mg/ml
Maltese: TAS-SUSTANZA(i) ATTIVA(I) Pradofloxacin 25 mg/ml
English: ROUTE(S) OF ADMINISTRATION Oral use.
Maltese: MOD(I) TA' AMMINISTRAZZJONI Użu orali.
English: Infrequent vomiting was observed in cats after repeated oral administration of 2.7 times the maximum recommended dose.
Maltese: Ġie osservat rimettar b'mod mhux frekwenti wara amministrazzjoni orali ripetuta ta' 2.7 drabi d-doża massima rakkomandata.
English: Manufacturer responsible for batch release: KVP Pharma +Veterinär Produkte GmbH Projensdorfer Str. 324
Maltese: Manifattur responsabbli għall-ħrug tal-lott: KVP Pharma +Veterinär Produkte GmbH Projensdorfer Str.
English: Magnesium stearate Silica, colloidal anhydrous Artificial beef flavour Croscarmellose sodium
Maltese: Magnesium stearate Silica, colloidal anhydrous Togħma artifiċjali taċ-ċanga
English: Pradofloxacin is eliminated from serum with a terminal half-life of 9 hours.
Maltese: Pradofloxacin huwa eliminat miss-serum b'half-life terminali ta' 9 sigħat.
English: PHARMACEUTICAL FORM Oral suspension
Maltese: GĦAMLA FARMAĊEWTIKA Sospensjoni orali
English: The combined use of fluoroquinolones with digoxin should also be avoided because of potentially increased oral bioavailability of digoxin.
Maltese: L-użu kombinat ta' Fluoroquinolones ma' digoxin għandu jiġi evitat ukoll minħabba żieda potenzjali fil-bijodisponibiltà orali ta' digoxin.
English: Resistance to fluoroquinolones has been reported to arise from five sources, (i) point mutations in the genes encoding for DNA gyrase and/or topoisomerase IV leading to alterations of the respective enzyme, (ii) alterations of drug permeability in Gram-negative bacteria, (iii) efflux mechanisms, (iv) plasmid mediated resistance and (v) gyrase protecting proteins.
Maltese: Ir-reżistenza għal Fluoroquinolones ġiet irrapportata li tinħoloq minn 5 sorsi, (i) mutazzjonijiet talpunti fil-ġeni li jikkodifikaw id-DNA gyrase u/jew topoisomerase IV li jwasslu għal alterazzjonijiet tal-enzim rispettiv, (ii) alterazzjonijiet tal-permeabilità tal-mediċina fil-batterji Gram-negattivi, (iii) ilmekkaniżmi ta' efluss, (iv) reżistenza plasmid medjata u (v) proteini li jipproteġu l-gyrase.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Pradofloxacin 25 mg/ml Preservative: Sorbic acid (E200)
Maltese: U INGREDJENT(I) OĦRA Sospensjoni orali li fiha 25 mg/ml pradofloxacin Preservattiv: Sorbic acid (E200)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/107/001-012
Maltese: FIS-SUQ EU/2/10/107/001-012
English: Although pradofloxacin has in-vitro activity against a wide range of Gram-positive and Gramnegative organisms, including anaerobic bacteria, this veterinary medicinal product should only be used for the approved indications (see section 4.2) and in accordance with the prudent use recommendations in section 4.5 of this SPC.
Maltese: Għalkemm Pradofloxacin għandu attività in-vitro kontra medda vasta ta' organiżmi Gram-pożittivi u Gram-negattivi, inkluż il-batterji anerobiċi, dan il-prodott mediċinali għandu jintuża biss għallindikazzjonijiet approvati (ara sezzjoni 4.2) u skont ir-rakkomandazzjonijiet ta' użu prudenti fissezzjoni 4.5 ta' dan l-SPC.
English: Folding carton containing 15 ml white high density polyethylene (HDPE) bottle with a polyethylene adapter and a child-resistant closure and a 3 ml polypropylene oral dosing syringe (graduation: 0.1 to 2 ml).
Maltese: Kartuna li tintlewa li fiha flixkun ta' 15 ml ta' polyethylene b'densità għolja (HDPE) abjad b'adattur tal-polyethylene u għeluq reżistenti għat-tfal u siringa ta' dożaġġ orali ta' polypropylene ta' 3 ml (gradwazzjoni: 0.1 sa 2 ml).
English: Pradofloxacin is eliminated from serum with a terminal half-life of 7 hours.
Maltese: Pradofloxacin huwa eliminat mis-serum b'half-life terminali ta' 7 sigħat.
English: Cross-resistance within the fluoroquinolone class of antimicrobials is common.
Maltese: Irreżistenza trasversali fi ħdan il-klassi ta' fluoroquinolone tal-antimikrobjali hija komuni.
English: The bacteria were isolated between 2001 and 2007 from clinical cases in Belgium, France, Germany, Hungary, Italy, Poland, Sweden and UK.
Maltese: Il-batterji ġew iżolati bejn l-2001 u l-2007 minn każijiet kliniċi fil-Belġju, Franza, il-Ġermanja, lUngerija, l-Italja, il-Polonja, l-Iżvezja u r-Renju Unit.
English: - 15 ml bottle and a 3ml oral dosing syringe - 30 ml bottle
Maltese: - Flixkun ta' 15 ml u siringa ta' 3ml ta' dożaġġ orali - Flixkun ta' 30 ml
English: Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius).
Maltese: Pasteurella multocida Escherichia coli Il-grupp ta' Staphylococcus intermedius (inkluż S. pseudintermedius)