FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, take your [Invented name] tablet 6 hours before or after taking the other medicine.
Maltese: - Teħid ta' faħam mediċinali orali fl-istess ħin ma' pilloli [Isem Ivvintat] inaqqas l-azzjoni ta' [Isem Ivvintat].
English: Viale Certosa, 130 20156 Milano Italy
Maltese: Viale Certosa, 130 20156 Milano Italja
English: Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal
Maltese: Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugall
English: Berkshire RG14 1JA UK
Maltese: Berkshire RG14 1JA Renju Unit
English: BAYER SANTE 13, rue Jean Jaurès 92807 PUTEAUX CEDEX France
Maltese: BAYER SANTE 13, rue Jean Jaurès 92807 PUTEAUX CEDEX Franza
English: Streptococcus pyogenes* (Group A)
Maltese: Streptococcus pyogenes* (Grupp A)
English: Moraxella (Branhamella) catarrhalis* Anaerobic micro-organisms
Maltese: Moraxella (Branhamella) catarrhalis* Mikro-organiżmi anaerobiċi
English: Interference with culture test
Maltese: Interferenza b'test ta' kultura
English: Avenue Louise 143 B-1050 Bruxelles
Maltese: Avenue Louise 143 B-1050 Bruxelles Belġju
English: Absorption and Bioavailability
Maltese: Assorbiment u bijodisponibiltà
English: EE - Estonia
Maltese: EE - Estonja
English: Pharmacotherapeutic group: Quinolone antibacterials, fluoroquinolones, ATC code: J01 MA 14
Maltese: Anti-batteriċi quinolone, fluoroquinolones, Kodiċi ATC:J01 MA 14
English: EUCAST clinical MIC breakpoints for moxifloxacin (31.01.2006): Organism
Maltese: Punti kritiċi ta' MIC kliniċi EUCAST għal moxifloxacin (31.01.2006): Organiżmu
English: Streptococcus milleri group* (S. anginosus, S. constellatus and S. intermedius) Streptococcus pneumoniae*
Maltese: Grupp ta' Streptococcus milleri* (S. anginosus, S. constellatus u S. intermedius) Streptococcus pneumoniae*
English: BE - Belgium Bayer s.a.-n.v. Avenue Louise 143
Maltese: LU- Lussemburgu Bayer s.a.-n.v. Avenue Louise 143
English: The absolute bioavailability amounts to approximately 91%.
Maltese: Il-bijodisponibiltà assoluta hija ta' madwar 91%.
English: DK - Denmark
Maltese: DK - Danimarka
English: FI - Finland
Maltese: FI - Finlandja
English: This procedure is a referral following a Mutual Recognition Procedure concerning the above variation application which was submitted for Avalox film-coated tablets to Germany as Reference Member State (RMS) and the Concerned Member States (CMS) AT, BE, CY, CZ, DK, EE, EL, ES, FI, FR, HU, IE, IT, LT, LU, LV, MT, NL, PL, PT, SE, SI, SK and UK on 5 December 2006.
Maltese: Din il-proċedura hija riferiment wara Proċedura ta' Għarfien Reċiproku dwar l-applikazzjoni talvarjazzjoni msemmija fuq li ġiet sottomessa għall-pilloli miksijin b'rita ta' Avalox lill-Ġermanja bħala Stat Membru ta' Referenza (RMS) u lill-Istati Membri Konċernati (CMS) AT, BE, CY, CZ, DK, EE, EL, ES, FI, FR, HU, IE, IT, LT, LU, LV, MT, NL, PL, PT, SE, SI, SK u UK fil-5 ta' Diċembru ta' l2006.
English: LT - Lithuania
Maltese: LT - Litwanja
English: Bravničarjeva 13 1000 Ljubljana Slovenija
Maltese: BAYER d.o.o. Bravničarjeva 13 1000 Ljubljana Slovenja
English: SK - Slovakia
Maltese: SK - Slovakkja
English: LV - Latvia
Maltese: LV - Latvja
English: PL - Poland
Maltese: PL - Polonja
English: Staphylococcus aureus* (methicillin-susceptible) Streptococcus agalactiae (Group B)
Maltese: Staphylococcus aureus* (suxxettibli għal methicillin) Streptococcus agalactiae (Grupp B)
English: IE - Ireland
Maltese: IE - Irlanda
English: - Pregnancy and lactation (see section 4.6).
Maltese: Tqala u treddigħ (ara sezzjoni 4.6).
English: Moxifloxacin is distributed to extravascular spaces rapidly; after a dose of 400 mg an AUC of 35 m·gh/l is observed.
Maltese: Moxifloxacin huwa distribwit malajr fl-ispazji ekstravaskulari; wara doża ta' 400 mg hija osservata AUC ta' 35 m·gh/l.
English: PT - Portugal
Maltese: PT - Portugall
English: Avalox was initially approved in June 1999.
Maltese: Avalox kien approvat inizjalment f'Ġunju ta' l-1999.
English: M1 and M2 are the only metabolites relevant in humans, both are microbiologically inactive.
Maltese: M1 u M2 huma l-uniċi metaboliti rilevanti fil-bnedmin, it-tnejn huma mikrobijoloġikament inattivi.
English: Tissue
Maltese: Tessut
English: NL - Netherlands
Maltese: NL - Olanda
English: Cross-resistance is observed with other fluoroquinolones.
Maltese: Cross-resistance hija osservata b'fluoroquinolones oħra.
English: Peak and trough plasma concentrations at steady-state (400 mg once daily) were 3.2 and 0.6 mg/l, respectively.
Maltese: Konċentrazzjonijiet massimi u minimi fil-plażma fi stat fiss (400 mg darba kuljum) kienu 3.2 u 0.6 mg/l, rispettivament.
English: The mean apparent total body clearance following a 400 mg dose ranges from 179 to 246 ml/min.
Maltese: Ilmedja tat-tneħħija mill-ġisem apparenti totali wara doża ta' 400 mg tvarja minn 179 sa 246 ml/min.
English: Safety
Maltese: Is-Sigurtà
English: There is no indication of oxidative metabolism.
Maltese: M'hemmx indikazzjoni ta' metaboliżmu ossidattiv.
English: Therefore, do not take [Invented name] together with the following medicines: Medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, some antimicrobials (e.g. sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine), some antihistamines (e.g. terfenadine, astemizole, mizolastine), and other medicines (e.g. cisapride, intravenous vincamine, bepridil and diphemanil).
Maltese: Mediċini li jagħmlu parti mill-grupp ta' anti-arritmijaċi (e.ż. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), newrolettiċi (e.ż. phenothiazines, pimozide, sertindole, haloperidol, sultopride), antidepressanti triċikliċi, ċerti sustanzi kontra lmikrobi (e.ż. sparfloxacin, erythromycin ġol-vini, pentamidine, mediċini kontra l-malarja speċjalment halofantrine), ċerti antistaminiċi (e.ż. terfenadine, astemizole, mizolastine), u mediċini oħra (e.ż. cisapride, vincamine ġol-vini, bepridil u diphemanil).
English: Aerobic Gram-negative micro-organisms Haemophilus influenzae*
Maltese: Mikro-organiżmi aerobiċi negattiv għal Gram Haemophilus influenzae*
English: The Referral procedure was initiated on 15 November 2007 with the adoption of a CHMP List of Questions to be addressed by the MAHs.
Maltese: Il-proċedura ta' Riferiment inbdiet fil-15 ta' Novembru ta' l-2007 bl-adozzjoni ta' Lista ta' Mistoqsijiet tas-CHMP li kellhom jiġu indirizzati mill-MAHs.
English: - Quinolones have been shown to cause photosensitivity reactions in patients.
Maltese: - Quinolones intwerew li jikkawżaw reazzjonijiet ta' fotosensittività f'pazjenti.
English: HU - Hungary
Maltese: HU - Ungerija
English: Aerobic Gram-positive micro-organisms Gardnerella vaginalis
Maltese: Mikro-organiżmi aerobiċi pożittivi għal Gram Gardnerella vaginalis
English: Moxifloxacin is contraindicated in children and adolescents (< 18 years).
Maltese: Moxifloxacin huwa kontra-indikat fit-tfal u l-adoloxxenti (< 18-il sena).
English: IT - Italy
Maltese: IT - Italja
English: In the analysis of ECGs obtained in the clinical trial program, QTc prolongation with moxifloxacin was 6 msec ± 26 msec, 1.4% compared to baseline.
Maltese: Flanaliżi ta' l-ECGs miksuba fil-programm ta' prova klinika, it-titwil ta' QTc b'moxifloxacin kien ta' 6 msec ± 26 msec, 1.4% meta mqabbel mal-linja bażi.
English: Resistance mechanisms that inactivate penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not interfere with the antibacterial activity of moxifloxacin.
Maltese: Mekkaniżmi ta' reżistenza li jinattivaw penicillins, cephalosporins, aminoglycosides, macrolides u tetracyclines ma jinterferixxux ma' l-attività anti-batterika ta' moxifloxacin.
English: 3 from 3 h up to 36 h post dose 4 at the end of infusion
Maltese: 2 konċentrazzjoni tas-sustanza mhux imwaħħla 3 minn 3 h sa 36 h wara doża 4 fl-aħhar ta' l-infużjoni
English: The pharmacokinetic properties of moxifloxacin are not significantly different in patients with renal impairment (including creatinine clearance > 20 ml/min/1.73 m2).
Maltese: Il-kwalitajiet farmakokinetiċi ta' moxifloxacin mhumiex differenti b'mod sinifikanti f'pazjenti b'indeboliment renali (inkluż tneħħija tal-krejatinina > 20 ml/min/1.73 m2).
English: However, studies have shown that moxifloxacin has a lower risk to induce photosensitivity.
Maltese: Iżda, studji wrew li moxifloxacin għandu riskju aktar baxx li jinduċi fotosensittività.
English: “Other” micro-organisms
Maltese: Mikro-organiżmi “oħra”
English: In vitro and ex vivo experiments showed a protein binding of approximately 40 - 42% independent of the concentration of the drug.
Maltese: Esperimenti in vitro u ex vivo wrew twaħħil mal-proteini ta' madwar 40 - 42% independenti mill-konċentrazzjoni talmediċina.
English: UK - United Kingdom Bayer plc Bayer Schering Pharma Bayer House
Maltese: Bayer Schering Pharma Bayer House Strawberry Hill Newbury
English: [Invented name] is an antibiotic belonging to the quinolone family.
Maltese: [Isem Ivvintat] huwa anti-bijotiku li jagħmel parti mill-familja ta' quinolones.
English: Pharmacokinetics are linear in the range of 50 - 800 mg single dose and up to 600 mg once daily dosing over 10 days.
Maltese: Il-farmakokinetika hija lineari fil-firxa ta' doża waħda ta' 50 - 800 mg u sa dożaġġ ta' 600 mg darba kuljum fuq medda ta' 10 ġranet.
English: Bayer Vital GmbH 51368 Leverkusen Germany
Maltese: Bayer Vital GmbH 51368 Leverkusen Ġermanja
English: - Patients below 18 years of age.
Maltese: - Pazjenti b'età taħt 18-il sena.
English: Aerobic Gram-negative micro-organisms
Maltese: Mikro-organiżmi aerobiċi negattivi għal Gram
English: Maxillary sinus
Maltese: Sinus maxillari
English: Alveolar macrophages
Maltese: Makrofaġi alveolari
English: Aerobic Gram-negative micro-organisms Enterobacter cloacae* Escherichia coli*
Maltese: Mikro-organiżmi aerobiċi negattivi għal Gram Enterobacter cloacae*
English: Female genital tract*
Maltese: Apparat ġenitali femminili*
English: Following a 400 mg oral dose peak concentrations of 3.1 mg/l are reached within 0.5 - 4 h post administration.
Maltese: Wara doża orali ta' 400 mg konċentrazzjonijiet massimi ta' 3.1 mg/l jintlaħqu fi żmien 0.5 - 4 h wara l-għoti.
English: The following peak concentrations (geometric mean) were observed following administration of a single oral dose of 400 mg moxifloxacin:
Maltese: Il-konċentrazzjonijiet massimi li ġejjin (medja ġeometrika) kienu osservati wara għoti ta' doża orali waħda ta' 400 mg moxifloxacin:
English: [Invented name] tablets are for oral use.
Maltese: Pilloli ta' [Isem Ivvintat] fihom lactose.
English: and fastidious organisms (M100-S17, 2007) and MIC breakpoints for anaerobes (M11-A7, 2007):
Maltese: Punti kritiċi ta' MIC u tad-diffużjoni tad-disk ta' l-Istitut ta' Kriterji Kliniċi u tal-Laboratorju™ (CLSI) għal Staphylococcus spp. u organiżmi fastidjużi (M100-S17, 2007) u punti kritiċi ta' MIC għal anerobi (M11-A7, 2007):
English: After a 400 mg dose, recovery from urine (approximately 19% for unchanged drug, approximately 2.5% for M1, and approximately 14% for M2) and faeces (approximately 25% of unchanged drug, approximately 36% for M1, and no recovery for M2) totalled to approximately 96%.
Maltese: Wara doża ta' 400 mg, l-irkupru mill-awrina (madwar 19% għall-mediċina mhux mibdula, madwar 2.5% għal M1, u madwar 14% għal M2) u mill-purgar (madwar 25% għall-mediċina mhux mibdula, madwar 36% għal M1, u l-ebda rkupru għal M2) ammonta għal madwar 96%.
English: Ethmoid sinus
Maltese: Sinus etmoidali
English: concentrations of the M2 metabolite (glucuronide) increase by up to a factor of 2.5 (with a creatinine clearance of < 30 ml/min/1.73 m2).
Maltese: Kif il-funzjoni renali tonqos, il-konċentrazzjonijiet tal-metabolit M2 (glucuronide) tiżdied b'fattur sa 2.5 (bi tneħħija talkrejatinina ta' < 30 ml/min/1.73 m2).
English: EL - Greece
Maltese: EL - Greċja
English: Renal clearance amounted to about 24 - 53 ml/min suggesting partial tubular reabsorption of the drug from the kidneys.
Maltese: Ittneħħija renali tammonta għal madwar 24 - 53 ml/min u b'hekk tissuġġerixxi assorbiment tubulari parzjali mill-ġdid tal-mediċina mill-kliewi.
English: - Hypersensitivity and allergic reactions have been reported for fluoroquinolones including moxifloxacin after first administration.
Maltese: - Reazzjonijiet ta' sensittività eċċessiva u allerġiċi ġew irrapportati għal fluoroquinolones inkluż moxifloxacin wara l-ewwel għoti.
English: Bayer HealthCare AG 51 368 Leverkusen Germany
Maltese: Bayer HealthCare AG 51 368 Leverkusen Ġermanja
English: Blister fluid
Maltese: Fluwidu fin-nuffata
English: * intravenous administration of a single 400 mg dose 1 10 h after administration
Maltese: * għoti ġol-vini ta' doża waħda ta' 400 mg 1 10 h wara l-għoti
English: Before you take [Invented name] ..., Take special care ...).
Maltese: Qabel ma tieħu [Isem Ivvintat] ..., Oqgħod attent ħafna ...).
English: Clinical and Laboratory Standards Institute™ (CLSI), formerly NCCLS breakpoints are presented in the below table for MIC testing (mg/l) or disc diffusion testing (zone diameter [mm]) using a 5-µg moxifloxacin disc.
Maltese: Istitut ta' Kriterji Kliniċi u tal-Laboratorju™ (CLSI), punti kritċi NCCLS ta' qabel, huma ppreżentati fit-tabella taħt għall-ittestjar ta' MIC (mg/l) jew ittestjar tad-diffużjoni tad-disk (dijametru taż-żona [mm]) bl-użu ta' disk ta' 5-µg moxifloxacin.
English: - Quinolones are known to trigger seizures.
Maltese: Quinolones huma magħrufa li jikkawżaw eċċessjonijiet.
English: #ESBL-producing strains are commonly resistant to fluoroquinolones +Resistance rate > 50% in one or more countries
Maltese: #Razez li jipproduċu ESBL huma reżistenti b'mod komuni għal fluoroquinolones +Rata ta' reżistenza > 50% f'pajjiż wieħed jew aktar
English: - Patients with a history of tendon disease/disorder related to quinolone treatment.
Maltese: - Pazjenti b'passat ta' marda/disturb fit-tendon relata ma' kura b'quinolone.
English: Greece
Maltese: Belgju
English: H. influenzae and M. catarrhalis
Maltese: H. influenzae u M.
English: The MRP variation application DE/H/155/01/II/38 concerned an extension of the indication to include the treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis.
Maltese: L-applikazzjoni tal-varjazzjoni ta' l-MRP DE/H/155/01/II/38 kienet dwar estensjoni ta' l-indikazzjoni biex ikun inkluż it-trattament tal-marda infjammatorja tal-pelvis (PID) moderata jew severa, jiġifieri infezzjonijiet tal-parti ta' fuq tal-passaġġ ġenitali, inklużi s-salpinġite u l-endometrite.
English: Bayer HealthCare AG 51368 Leverkusen Germany
Maltese: Bayer HealthCare AG 51368 Leverkusen Ġermanja
English: Invented name Name
Maltese: LISTA TA`
English: Possible side effects).
Maltese: Effetti sekondarji li jista' jkollu).
English: [Invented name] contains moxifloxacin as the active ingredient which belongs to a group of antibiotics called fluoroquinolones.
Maltese: [Isem Ivvintat] fih moxifloxacin bħala sustanza attiva li tagħmel parti minn grupp ta' anti-bijotiċi msejħa fluoroquinolones.
English: The steady-state volume of distribution (Vss) is approximately 2 l/kg.
Maltese: Il-volum ta' distribuzzjoni fi stat fiss (Vss) huwa madwar 2 l/kg.
English: Minimum bactericidal concentrations (MBC) were found to be in the range of the minimum inhibitory concentrations (MIC).
Maltese: Konċentrazzjonijiet batteriċida minimi (MBC) instabu li kienu fil-firxa tal-konċentrazzjonijiet inibitorji minimi (MIC).
English: were reduced, as were the anaerobes Bacteroides vulgatus, Bifidobacterium spp., Eubacterium spp., and Peptostreptococcus spp.. For Bacteroides fragilis there was an increase.
Maltese: Escherichia coli, Bacillus spp., Enterococcus spp., u Klebsiella spp. kienu mnaqqsa, kif kienu wkoll anerobi Bacteroides vulgatus, Bifidobacterium spp., Eubacterium spp., u Peptostreptococcus spp.
English: Species for which acquired resistance may be a problem Aerobic Gram-positive micro-organisms Staphylococcus aureus (methicillin-resistant)+
Maltese: Speċi li għalihom reżistenza miksuba tista' tkun probema Mikro-organiżmi aerobiċi pożittivi għal Gram Staphylococcus aureus (reżistenti għal methicillin)+
English: Moxifloxacin undergoes Phase II biotransformation and is excreted via renal and biliary/faecal pathways as unchanged drug as well as in the form of a sulpho-compound (M1) and a glucuronide (M2).
Maltese: II u jitneħħa mir-rotot renali u biljari/talpurgar bħala mediċina mhux mibdula kif ukoll f'forma ta' sustanza sulfo (M1) u glucuronide (M2).
English: Moxifloxacin therapy may give false negative culture results for Mycobacterium spp.
Maltese: Terapija b'moxifloxacin tista' tagħti riżultati tal-kultura negattivi foloz għal Mycobacterium spp. permeżż ta' sopressjoni tat-tkabbir tal-Mycobacteria.
English: - Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with quinolones.
Maltese: - Pazjenti b'passat fil-familja ta' nuqqas ta' glucose-6-phosphate dehydrogenase attwali huma suxxettibli għal reazzjonijiet emolitiċi meta kkurati b'quinolones.
English: Due to limited clinical data, moxifloxacin is also contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase > 5fold ULN.
Maltese: Minħabba tagħrif kliniku limitat, moxifloxacin huwa kontra-indikat ukoll f'pazjenti b'indeboliment tal-funzjoni tal-fwied (Child Pugh C) u f'pazjenti b'żjieda fit-transaminases ta' > 5 darbiet tal-ULN.
English: Route of administration
Maltese: Intermedju Reżistenti
English: - Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: - Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, nuqqas ta' Lapp lactase, jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: - The Committee considered the Referral made under Article 6(12) of Commission Regulation (EC) No 1084/2003, for Avalox and associated names (See Annex 1).
Maltese: - Il-Kumitat ikkunsidra r-Riferiment magħmul skond l-Artikolu 6(12) tar-Regolament talKummissjoni (KE) Nru 1084/2003, għal Avalox u ismijiet assoċjati (ara l-Anness 1).
English: Moxifloxacin is eliminated from plasma with a mean terminal half life of approximately 12 hours.
Maltese: Moxifloxacin huwa eliminat mill-plażma b'medja tal-half-life terminali ta' madwar 12-il siegħa.
English: 30588 Murcia
Maltese: ESPAÑA, SL Crta. De Zeneta, 149 30588 Murcia Spanja
English: Pseudomonas aeruginosa *Activity has been satisfactorily demonstrated in susceptible strains in clinical studies in the approved clinical indications.
Maltese: Pseudomonas aeruginosa *Attività kienet murija b'mod sodisfaċenti f'razez suxxettibli fi studji kliniċi fl-indikazzjonijiet kliniċi approvati.
English: Following oral administration moxifloxacin is rapidly and almost completely absorbed.
Maltese: Wara għoti orali moxifloxacin huwa assorbit malajr u kważi kompletament.
English: Resistant
Maltese: RECORDATI
English: Bronchial mucosa
Maltese: Mukuża tal-bronki
English: Impaired liver function was associated with higher exposure to M1 in plasma, whereas exposure to parent drug was comparable to exposure in healthy volunteers.
Maltese: Indeboliment tal-funzjoni tal-fwied kienet assoċjata ma' esponiment ogħla għal M1 filplażma, filwaqt li esponiment għall-mediċina oriġinali kien komparabbli għall-esponiment f'voluntiera b'saħħithom.
English: [Invented name] is used in adults for treating the following bacterial infections: - Sudden worsening of chronic bronchitis (acute exacerbation of chronic bronchitis) - Infection of the lungs (pneumonia) acquired outside the hospital, except severe cases - Acute infection of the sinuses (acute bacterial sinusitis) - Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and infections of the uterus mucous membrane.
Maltese: - Infezzjoni akuta tas-sinusis (sinożite akuta mill-batterja) - Infezzjonijiet ħfief sa moderati ta' l-apparat ġenitali ta' fuq tal-mara (marda infjammatorja talpelvi), inkluż infezzjonijiet tat-tubi fallopjani u infezzjonijiet tal-membrana mukuża ta' l-utru.
English: Renal/hepatic impairment
Maltese: Indeboliment renali/tal-fwied
English: - The Committee considered that robust data is available showing the efficacy of Avalox in the indication “Treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis” , however due to emerging resistance of N. gonorrhoeae, moxifloxacin should not be used in empirical monotherapy, unless moxifloxacinresistant N. gonorrhoeae can be excluded.
Maltese: - Il-Kumitat ikkunsidra li hemm dejta robusta li turi l-effikaċja ta' Avalox fl-indikazzjoni “Trattament ta' mard infjammatorju tal-pelvis (PID) ħafif jew moderat, jiġifieri infezzjonijiet tal-passaġġ ġenitali ta' fuq, inklużi s-salpinġite u l-endometrite”, madankollu minħabba r-reżistenza li qed tiżviluppa minn N. gonorrhoeae, moxifloxacin m'għandux jintuża fil-monoterapija empirika, sakemm ma tkunx tista' tiġi eskluża razza ta' N. gonorrhoeae reżistenti għal moxifloxacin.
English: To cover all etiologic agents of PID a combination with another antibiotic class such as the cephalosporins (e.g. ceftriaxone 250 mg intramuscular (IM) in a single dose) should be given empirically, which would be similar to other recommended treatment regimens given in combination.
Maltese: Biex ikunu koperti l-aġenti kollha li jistgħu jikkawżaw PID, għandha tingħata empirikament kombinazzjoni ma' klassi antibijotika oħra bħal cephalosporins (per eżempju doża waħdanija ta' 250 mg ceftriaxone fil-muskolu (IM) f'doża waħdanija), li tkun simili għal programmi ta' trattament rakkomandati oħra mogħtija f'kombinazzjoni.
English: Susceptible
Maltese: Suxxettibilità
English: Austria
Maltese: Wien
English: In clinical trials the tablets have been studied for up to 14 days treatment.
Maltese: Flistudji kliniċi il-pilloli ġew studjati sa massimu ta' 14-il jum trattament.
English: It appears that the C8-methoxy moiety contributes to enhanced activity and lower selection of resistant mutants of Gram-positive bacteria compared to the C8-H moiety.
Maltese: Jidher li l-parti ta' C8-methoxy tikkontribwixxi attività msaħħa u selezzjoni aktar baxxa għallmutanti reżistenti ta' batterja pożittiva għal Gram meta mqabbel mal-parti C8-H.
English: For reasons of drug safety, moxifloxacin is therefore contraindicated in patients with: - Congenital or documented acquired QT prolongation - Electrolyte disturbances, particularly in uncorrected hypokalaemia - Clinically relevant bradycardia - Clinically relevant heart failure with reduced left-ventricular ejection fraction - Previous history of symptomatic arrhythmias Moxifloxacin should not be used concurrently with other drugs that prolong the QT interval (see also section 4.5).
Maltese: Kemm f'investigazzjonijiet prekliniċi kif ukoll fil-bnedmin, wara esponiment għal moxifloxacin, kienu osservati tibdiliet fl-elettrofiżjoloġija kardijaka fil-forma ta' titwil ta' QT. Għalhekk, għarraġunijiet ta' sigurtà tal-mediċina, moxifloxacin huwa kontra-indikat f'pazjenti b': Titwil ta' QT miksub b'mod konġenitali jew dokumentat Disturbi fl-elektroliti, partikolarment f'każ ta' ipokalimja mhux ikkoreġuta Bradikardija ta' rilevanza klinika - Insuffiċjenza tal-qalb ta' rilevanza klinika bi frazzjoni ta' tneħħija ventrikolari tax-xellug imnaqqsa Passat ta' arritmija sintomatika Moxifloxacin m'għandux jintuża fl-istess waqt ma' mediċini oħra li jtawwlu l-intervall ta' QT (ara wkoll sezzjoni 4.5).
English: In clinical Phase I and in vitro studies no metabolic pharmacokinetic interactions with other drugs undergoing Phase I biotransformation involving cytochrome P450 enzymes were observed.
Maltese: Fi studji kliniċi ta' Fażi I u in vitro ma kienu osservati l-ebda interazzjonijiet farmakokiniċi metaboliċi ma' mediċini oħra li jgħaddu minn bijotrasformazzjoni ta' Fażi I li tinvolvi enżimi taċ-ċitokromju P450.
English: Epithelial lining fluid
Maltese: Fluwidu tal-kisja talepitilju