FrancophonIA/ELRC3.0 huggingface dataset:
English: Irbesartan Hydrochlorothiazide Zentiva must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Maltese: Irbesartan Hydrochlorothiazide Zentiva ma għandux jintuża wkoll minn pazjenti li jbatu minn problemi gravi fil-fwied, kliewi jew problemi biljari, persuni li jkollhom livelli wisq baxxi ta' potassju fid-demm, jew livelli wisq għoljin ta' kalċju fid-demm.
English: Irbesartan Hydrochlorothiazide Zentiva is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Maltese: Irbesartan Hydrochlorothiazide Zentiva huwa mediċina li fiha żewġ sustanzi attivi, l-irbesartan u lidroklorotijażide.
English: How does Irbesartan Hydrochlorothiazide Zentiva work?
Maltese: X'inhu Irbesartan Hydrochlorothiazide Zentiva?
English: Irbesartan Hydrochlorothiazide Zentiva was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Maltese: Irbesartan Hydrochlorothiazide Zentiva rriżulta aktar effikaċi mill-plaċebo (trattament finta) u millidroklorotijażide waħdu fit-tnaqqis tal-pressjoni tad-demm dijastolika.
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: [Isem u indirizz] <{telefon}> <{fax}> <{e-mail}>
English: 95, Marathonos Avenue 190-09 Pikermi Greece
Maltese: 95, Marathonos Avenue 190-09 Pikermi Il-Greċja
English: 7 - 21 days
Maltese: 7 - 21 ġurnata
English: À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado
Maltese: 4745-457 S. Mamede do Coronado
English: Common ≥ 1/100 to < 1/10
Maltese: Komuni ≥ 1/100 sa < 1/10
English: Streptococcus agalactiae (Group B)
Maltese: Streptococcus agalactiae (Grupp B)
English: Bialfar - Produtos Farmacêuticos S.A.
Maltese: Bialfar - Produtos Farmacêuticos S.A. À Av. da Siderurgia Nacional
English: Pharmacotherapeutic group: Quinolone antibacterials, fluoroquinolones, ATC code: J01MA14
Maltese: Anti-batteriċi quinolone, fluoroquinolones, Kodiċi ATC:J01 MA 14
English: Anaerobic micro-organisms
Maltese: Mikro-organiżmi anaerobiċi
English: EUCAST clinical MIC breakpoints for moxifloxacin (31.01.2006): Organism
Maltese: Punti kritiċi kliniċi ta' MIC skond EUCAST għal moxifloxacin (31.01.2006): Organiżmu
English: Active ingredient: Moxifloxacin
Maltese: Moxifloxacin
English: Increased gamma-glutamyl-transferase
Maltese: Żjieda fil-gamma-glutamyl-transferase
English: Sodium content: 34 mmol/250 ml
Maltese: Kontenut ta' sodium: 34 mmol/250 ml
English: Microbiological Susceptibility
Maltese: Suxxettibilità mikrobijoloġika
English: This might lead to an increased risk of ventricular arrhythmias, including torsade de pointes.
Maltese: Dan jista' jwassal għal żjieda fir-riskju ta' arritmija ventrikulari, inkluż torsades de pointes.
English: Packs of 5 and 12 bags.
Maltese: Pakketti ta' 5 u 12-il borża.
English: Moxifloxacin IV for CAP was approved through MRP in two subsequent waves, in 2002 and 2004.
Maltese: Moxifloxacin IV għal CAP ġie approvat permezz ta' MRP f'żewġ fażijiet suċċessivi, fl-2002 u fl-2004.
English: However, such data may indicate a true excess risk of hepatotoxicity for the IV formulation.
Maltese: Madankollu, tali dejta tista' tindika riskju eċċessiv reali ta' epatotossiċità għall-formulazzjoni IV.
English: SCIENTIFIC CONCLUSIONS
Maltese: Punti Kritiċi
English: Uncommon: Dehydration Rare:
Maltese: Mhux komuni: Deidrazzjoni Rari:
English: Refer to sections 4.3, 4.4 and 4.5.
Maltese: Irreferi għassezzjonijiet 4.3, 4.4 u 4.5.
English: The recommended total duration of intravenous and oral treatment is 7 - 14 days for CAP and 7 - 21 days for cSSSI.
Maltese: It-tul totali rrakkomandat ta' kura fil-vini u orali huwa 7 - 14-il ġurnata għal CAP u 7 - 21 ġurnata għal cSSSI.
English: The corresponding peak concentration in alveolar macrophages amounted to 56.7 mg/kg.
Maltese: Il-konċentrazzjoni massima fil-makrofaġi ta' l-alveoli li tikkorrispondi laħqet 56.7 mg/kg.
English: Treatment of CAP
Maltese: Trattament tal-CAP
English: Chlamydophila (Chlamydia) pneumoniae*
Maltese: Chlamydophila (Chlamydia) pneumoniae* Coxiella burnetii
English: Maximum concentrations of 5.4 mg/kg and 20.7 mg/l (geometric mean) were reached in bronchial mucosa and epithelial lining fluid, respectively, 2.2 h after an oral dose.
Maltese: Konċentrazzjonijiet massimi ta' 5.4 mg/kg u 20.7 mg/l (medja ġeometrika) intlaħqu fil-mukuża talbronki u fil-fluwidu tal-kisja ta' l-epitelju, rispettivament, 2.2 h wara doża orali.
English: Uncommon: Anxiety, restlessness/agitation Rare:
Maltese: Mhux komuni: Ansjetà, irrekwitezza/aġitazzjoni Rari:
English: The mean apparent total body clearance following a 400 mg dose ranges from 179 to 246 ml/min.
Maltese: Il-medja tat-tneħħija mill-ġisem apparenti totali wara doża ta' 400 mg tvarja minn 179 sa 246 ml/min.
English: Moxifloxacin hydrochloride is a synthetic antibacterial agent of the fluoroquinolone class.
Maltese: Moxifloxacin hydrochloride huwa aġent antibatterjali sintetiku tal-klassi ta' fluoroquinolone.
English: Moxifloxacin resistance rate of > 50% have been reported for methicillin resistant S. aureus.
Maltese: +Kienet irrapportata rata ta' reżistenza għal Moxifloxacin ta' > 50% għal S. aureus reżistenti għal methicillin.
English: POSSIBLE SIDE EFFECTS
Maltese: Effetti sekondarji ġenerali
English: Water for injections, sodium chloride 0.9%, sodium chloride 1 molar, glucose 5%/10%/40%, Xylitol 20%, Ringer's solution, compound sodium lactate solution (Hartmann's solution, Ringer-lactate solution).
Maltese: Ilma għall-injezzjonijiet, Sodium chloride 0.9%, Sodium chloride 1 molar, Glucose 5%/10%/40%, Xylitol 20%, soluzzjoni ta' Ringer, soluzzjoni ta' Compound Sodium Lactate (soluzzjoni ta' Hartmann, soluzzjoni ta' Ringer-Lactate).
English: Anxiety reactions Psychomotor hyperactivity / agitation
Maltese: Attività psikomotorja eċċessiva / aġitazzjoni
English: Unspecified arrhythmias Torsade de Pointes (see section 4.4) Cardiac arrest (see section 4.4)
Maltese: Arritmiji mhux speċifikati Torsade de Pointes (ara sezzjoni 4.4) Waqfien kardijaku (ara sezzjoni 4.4)
English: The frequency of possible side effects listed below is defined using the following convention:
Maltese: Il-frekwenza ta' l-effetti sekondarji possibli elenkati taħt hija definita bl-użu tal-konvenzjoni li ġejja:
English: The first submission of moxifloxacin IV for CAP in 2002 included data from 550 moxifloxacin-treated subjects from two controlled clinical trials, which were later supplemented with an additional 942 subjects from five additional CAP studies.
Maltese: Lewwel sottomissjoni ta' moxifloxacin IV għal CAP fl-2002 kienet tinkludi dejta minn 550 suġġett ittrattat b'moxifloxacin minn żewġ provi kliniċi kkontrollati, li aktar tard ġew miżjuda b'942 suġġett addizzjonali minn ħames studji addizzjonali tal-CAP.
English: Infections Common:
Maltese: Infezzjonijiet Komuni:
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 ta' > 20 ml/min/1.73 m2).
English: 1 ml contains 1.6 mg moxifloxacin as hydrochloride.
Maltese: 1 ml fih 1.6 mg moxifloxacin bħala hydrochloride.
English: Apart from nausea and diarrhoea all adverse reactions were observed at frequencies below 3%.
Maltese: Minbarra tqalligħ u dijarea r-reazzjonijiet avversi kollha kienu osservati bi frekwenza inqas minn 3%.
English: Muscle rigidity Exacerbation of symptoms of myasthenia gravis (see section 4.4)
Maltese: Irkadar ta' sintomi ta' myasthenia gravis (ara sezzjoni 4.4)
English: Tendon rupture (see section 4.4) Arthritis
Maltese: Tiċrit tat-tendon (ara sezzjoni 4.4) Artrite
English: The following solutions were incompatible with Octegra: Sodium chloride 10% and 20% solutions, Sodium bicarbonate 4.2% and 8.4% solutions
Maltese: Soluzzjonijiet ta' 10% u 20% sodium chloride, Soluzzjonijiet ta' 4.2% u 8.4% sodium bicarbonate
English: 250 ml pack available in cartons of 5 and 12 bags.
Maltese: Pakkett ta' 250 ml disponibbli f'kaxex ta' 5 u 12-il borża.
English: Therefore co-administration of moxifloxacin with any of the following medicinal products is contraindicated (see also section 4.3): - antiarrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide) - antiarrhythmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) - neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride) - tricyclic antidepressive agents - certain antimicrobial agents (sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine) - certain antihistaminics (terfenadine, astemizole, mizolastine) - others (cisapride, vincamine IV, bepridil, diphemanil).
Maltese: Għalhekk l-għoti ta' moxifloxacin flimkien mal-prodotti mediċinali li ġejjin huwa kontra-indikat (ara wkoll sezzjoni 4.3): sustanzi kontra l-arritmija ta' klassi IA (eż. quinidine, hydroquinidine, disopyramide) sustanzi kontra l-arritmija ta' klassi III (eż. amiodarone, sotalol, dofetilide, ibutilide) newrolettiċi (eż. phenothiazines, pimozide, sertindole, haloperidol, sultopride) sustanzi antidepressivi triċikliċi ċertu sustanzi kontra l-mikrobi (sparfloxacin, erythromycin IV, pentamidine, sustanzi kontra lmalarja speċjalment halofantrine) ċertu antistaminiċi (terfenadine, astemizole, mizolastine) - oħrajn (cisapride, vincamine IV, bepridil, diphemanil).
English: Method of administration For intravenous use; constant infusion over 60 minutes (see also section 4.4).
Maltese: Metodu ta' kif għandu jingħata Użu għal ġol-vini; infużjoni kostanti fuq medda ta' 60 minuta (ara wkoll sezzjoni 4.4).
English: After intravenous administration findings indicative of systemic toxicity were most pronounced when moxifloxacin was given by bolus injection (45 mg/kg) but they were not observed when moxifloxacin (40 mg/kg) was given as slow infusion over 50 minutes.
Maltese: Wara għoti fil-vini sejbiet li jindikaw tossiċità sistemika kienu l-aktar evidenti meta moxifloxacin ingħata permezz ta' injezzjoni bolus (45 mg/kg) iżda ma kienux osservati meta moxifloxacin (40 mg/kg) ingħata bħala infużjoni bil-mod fuq medda ta' 50 minuta.
English: Rupture of tendon, inflammation of joints, muscle rigidity, worsening of the symptoms of myasthenia gravis
Maltese: Tiċrita tat-tendon, infjammazzjoni tal-ġogi, riġidità tal-muskoli, s-sintomi ta' myasthenia gravis jaggravaw
English: Uncommon: Distinct alteration of the electrical activity of the heart (ECG), palpitations, irregular and fast heart beat, severe cardiac rhythm abnormalities, angina pectoris, flushing
Maltese: Mhux komuni: Bidla ċara fl-attività elettrika tal-qalb (ECG), palpitazzjonijiet, rata ta' taħbit tal-qalb irregolari u mgħaġġla, anormalitajiet severi fir-ritmu tal-qalb, angina pectoris, fwawar
English: Before you use Octegra..., Take special care ...).
Maltese: Qabel ma tuża Octegra ..., Oqgħod attent ħafna ...).
English: In Phase III-IV clinical studies, the rates of cardiac adverse events, drug-related cardiac adverse events and serious cardiac adverse events were similar between moxifloxacin and the comparator.
Maltese: Flistudji kliniċi tal-Fażi III-IV, ir-rati ta' avvenimenti avversi kardijaċi, avvenimenti avversi kardijaċi relatati mal-mediċini u avvenimenti avversi kardijaċi serji kienu simili bejn moxifloxacin u lkomparatur.
English: QT prolongation (see section 4.4) Palpitations Tachycardia Atrial fibrillation Angina pectoris Vasodilatation
Maltese: Titwil tal-QT (ara sezzjoni 4.4) Palpitazzjonijiet Takikardija Fibrillazzjoni atrijali
English: Pharmacokinetics are linear in the range of 50 - 1200 mg single oral dose, up to 600 mg single intravenous dose and up to 600 mg once daily dosing over 10 days.
Maltese: Il-farmakokinetika hija lineari fil-firxa ta' doża orali waħda ta' 50 - 1200 mg, sa doża waħda fil-vini ta' 600 mg u sa dożaġġ ta' 600 mg darba kuljum fuq medda ta' għaxart ijiem.
English: Safety in the treatment of CAP
Maltese: Sigurtà fit-trattament tal-CAP
English: As renal function decreases, 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: Excipient: 250 ml of solution for infusion contains 34 mmol sodium.
Maltese: Sustanzi mhux attivi: 250 ml ta' soluzzjoni għall-infużjoni fiha 34 mmol sodium.
English: Muscular and Joint System Uncommon: Joint pain, muscle pain Rare:
Maltese: Sistema Muskolari u tal-ġogi Mhux komuni: Uġigħ fil-ġogi, uġigħ fil-muskoli Rari:
English: - Pregnancy and lactation (see section 4.6).
Maltese: - Tqala u treddigħ (ara sezzjoni 4.6).
English: Moxifloxacin is distributed to extravascular spaces rapidly.
Maltese: Moxifloxacin huwa distribwit malajr fl-ispazji ekstravaskulari.
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 4042% independenti mill-konċentrazzjoni tal-mediċina.
English: Clinical studies have shown no interactions following concomitant administration of moxifloxacin with: ranitidine, probenecid, oral contraceptives, calcium supplements, morphine administered parenterally, theophylline or itraconazole.
Maltese: Studji kliniċi ma wrew l-ebda interazzjonijiet wara għoti ta' moxifloxacin flimkien ma': ranitidine, probenecid, kontraċettivi orali, supplementi tal-kalċju, morphine mogħti b'mod parenterali, theophylline jew itraconazole.
English: See also sections 4.3 and 4.5.
Maltese: Ara wkoll sezzjonijiet 4.3 u 4.5.
English: In addition, the lower 95% CI in the primary analyses exceeded or bordered on -10%, which adds to the opinion that IV/PO moxifloxacin is not an optimal overall treatment for cSSSI.
Maltese: Barra minn hekk, is-CI 95% l-aktar baxx fl-analiżijiet primarji qabeż jew kien joqrob -10%, u dan iżid malopinjoni li moxifloxacin IV/PO mhuwiex trattament ġenerali ottimali għal cSSSI.
English: The Applicant presented a summary of the monitoring of the susceptibility of relevant bacterial species to moxifloxacin through a systematic literature review.
Maltese: L-Applikant ippreżenta sommarju tal-monitoraġġ tas-suxxettibbiltà ta' speċi ta' batterji rilevanti għal moxifloxacin permezz ta' reviżjoni sistematika tal-letteratura.
English: 1 ml contains 1.6 mg moxifloxacin (as hydrochloride).
Maltese: 1 ml fih 1.6 mg moxifloxacin (bħala hydrochloride).
English: - This medicinal product contains 787 mg (approximately 34 mmol) sodium per dose.
Maltese: - Dan il-prodott mediċinali fih 787 mg (madwar 34 mmol) ta' sodium f'kull doża.
English: Outcomes by pathogen did not reveal any potentially alarming differences between treatments.
Maltese: L-eżiti għal kull patoġenu ma wrew ebda differenza potenzjali allarmanti bejn it-trattamenti.
English: - Patients with a history of tendon disease/disorder related to quinolone treatment.
Maltese: - Pazjenti b'passat ta' marda/disturbi fit-tendon relatati ma' kura b'quinolone.
English: Therefore, do not take the following medicines during treatment with Octegra: 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: Għalhekk, tieħux il-mediċini li ġejjin flimkien ma' Octegra: Mediċini li jagħmlu parti mill-grupp ta' anti-arritmijaċi (eż. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), newrolettiċi (eż. phenothiazines, pimozide, sertindole, haloperidol, sultopride), antidepressanti triċikliċi, ċertu sustanzi kontra lmikrobi (eż. sparfloxacin, erythromycin ġol-vini, pentamidine, mediċini kontra l-malarja speċjalment halofantrine), ċertu antistamini (eż. terfenadine, astemizole, mizolastine), u mediċini oħra (eż. cisapride, vincamine ġol-vini, bepridil u diphemanil).
English: Moxifloxacin inhibits bacterial type II topoisomerases (DNA gyrase and topoisomerase IV) that are required for bacterial DNA replication, transcription and repair.
Maltese: Moxifloxacin jinibixxi topoisomerases tat-tip II (DNA gyrase u topoisomerase IV) li huma meħtieġa għar-replikazzjoni, transkrizzjoni u tiswija tad-DNA tal-batterji.
English: - You may develop diarrhoea whilst taking, or after taking, antibiotics including Octegra.
Maltese: - Inti tista' tiżviluppa dijarea waqt li qed tieħu jew wara li ħadt, antibijotiċi inkluż Octegra.
English: This applied to the overall incidence rates during IV/oral therapy and during initial IV therapy.
Maltese: IV/orali u matul it-terapija IV inizjali.
English: Headache Dizziness
Maltese: Mod ta' azzjoni
English: Initial intravenous treatment may be followed by oral treatment with moxifloxacin 400 mg tablets, when clinically indicated.
Maltese: Kura inizjali fil-vini tista' tkun segwita minn kura orali b'pilloli moxifloxacin 400 mg, meta klinikament indikat.
English: grand mal convulsions (see section 4.4) Disturbed attention Speech disorders Amnesia
Maltese: Aċċessjonijiet inkluż konvulżjonijiet grand mal (ara sezzjoni 4.4) Attenzjoni disturbata Disturbi fil-kliem Amnesija
English: - Quinolones are known to trigger seizures.
Maltese: - Quinolones huma magħrufa li jikkawżaw aċċessjonijiet.
English: In vitro studies with human cytochrome P450 enzymes support these findings.
Maltese: Studji in vitro b'enzimi taċ-ċitokromju P450 umani jsostnu dawn is-sejbiet.
English: PHARMACEUTICAL FORM AND CONTENTS 5 bags with 250 ml solution for infusion 12 bags with 250 ml solution for infusion
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 5 boroż b'250 ml ta' soluzzjoni għall-infużjoni 12-il borża b'250 ml ta' soluzzjoni għall-infużjoni
English: - Hypersensitivity and allergic reactions have been reported for fluoroquinolones including moxifloxacin after first administration.
Maltese: - Reazzjonijiet ta' sensittività eċċessiva u allerġiċi kienu irrapportati għal fluoroquinolones inkluż moxifloxacin wara l-ewwel għoti.
English: Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment) Water for injections
Maltese: Hydrochloric acid (għall-aġġustament tal-pH) Sodium hydroxide (għall-aġġustament tal-pH)
English: The following solutions are incompatible with moxifloxacin solution for infusion: Sodium chloride 10% and 20% solutions
Maltese: Is-soluzzjonijiet li ġejjin mhux kompatibbli ma' moxifloxacin soluzzjoni għall-infużjoni: Soluzzjonijet ta' sodium chloride ta' 10% u 20%
English: Moxifloxacin undergoes Phase II biotransformation and is excreted via renal (approximately 40%) and biliary/faecal (approximately 60%) pathways as unchanged drug as well as in the form of a sulphocompound (M1) and a glucuronide (M2).
Maltese: II u jitneħħa mir-rotot renali (madwar 40%) u biljari/tal-purgar (madwar 60%) bħala mediċina mhux mibdula kif ukoll f'forma ta' sustanza sulfo (M1) u glucuronide (M2).
English: The Applicant discussed in depth the advantages of moxifloxacin for the treatment of CAP requiring initial IV therapy, providing data from clinical studies on the efficacy of moxifloxacin IV/oral, hepatic safety in sequential IV/oral and from studies on the cardiac safety in IV/oral.
Maltese: L-Applikant iddiskuta fil-fond il-vantaġġi ta' moxifloxacin għattrattament tal-CAP li jirrikjedi terapija IV inizjali, filwaqt li pprovda dejta minn studji kliniċi dwar leffikaċja ta' moxifloxacin IV/orali, is-sigurtà epatika f'IV/orali sekwenzjali u minn studji dwar issigurtà kardijaka f'IV/orali.
English: Octegra can be administered via a T-tube together with the following solutions:
Maltese: Octegra jista' jingħata permezz ta' T-tube flimkien mas-soluzzjonijiet li ġejjin:
English: The following co-infusions were found to be compatible with moxifloxacin 400 mg solution for infusion: Water for injections, Sodium chloride 0.9%, Sodium chloride 1 molar, Glucose 5%/10%/40%, Xylitol 20%, Ringer's solution, Compound Sodium Lactate Solution (Hartmann's Solution, Ringer-Lactate Solution).
Maltese: Ilma għall-injezzjonijiet, Sodium chloride 0.9%, Sodium chloride 1 molar, Glucose 5%/10%/40%, Xylitol 20%, soluzzjoni ta' Ringer, Soluzzjoni ta' Compound Sodium Lactate (Soluzzjoni ta' Hartmann, Soluzzjoni ta' Ringer-Lactate).
English: In skin blister fluid concentrations of 1.75 mg/l were observed 10 h after intravenous administration.
Maltese: Fil-fluwidu ta' nfafet fil-ġilda kienu osservati konċentrazzjoni ta' 1.75 mg/l 10 h wara għoti fil-vini.
English: The cumulative review of spontaneous ADR reports of serious “possible drug related hepatic disorders” on IV only or IV/oral sequential treatment, suggested that serious moxifloxacin-induced hepatic events were very rare, unpredictable and idiosyncratic and that the benefit-risk has not changed for IV moxifloxacin.
Maltese: Ir-reviżjoni kumulattiva ta' rapporti spontanji ta' ADR ta' “possibbiltà ta' disturbi epatiċi relatati mal-mediċina” serji fuq trattament IV biss jew IV/orali sekwenzjali, issuġġeriet li avvenimenti epatiċi serji indotti minn moxifloxacin kienu rari ħafna, mhux prevedibbli u idjosinkratiċi u li l-benefiċċju-riskju ma nbidilx għal moxifloxacin IV.
English: If medically indicated the solution for infusion can be administered via a T-tube, together with compatible infusion solutions (see section 6.6).
Maltese: Jekk medikament indikat is-soluzzjoni għall-infużjoni tista' tingħata permezz ta' T-tube, flimkien ma' soluzzjonijiet għall-infużjoni kompatibbli (ara sezzjoni 6.6).
English: Therefore no clinically relevant interaction was observed between moxifloxacin and glibenclamide.
Maltese: Għalhekk ma kienet osservata lebda interazzjoni ta' rilevanza klinika bejn moxifloxacin u glibenclamide.
English: Allergic reaction (see section 4.4)
Maltese: Reazzjoni allerġika (ara sezzjoni 4.4)
English: Bayer HealthCare AG 51368 Leverkusen Germany
Maltese: Bayer HealthCare AG 51368 Leverkusen
English: Musculoskeletal, connective tissue and bone disorders
Maltese: Disturbi muskoluskeletriċi, tattessuti konnettivi u tal-għadam
English: In the interstitial fluid unbound concentration time profiles similar to those in plasma were found with unbound peak concentrations of 1.0 mg/l (geometric mean) reached approximately 1.8 h after an intravenous dose.
Maltese: Fil-fluwidu ta' l-interstizju nstabu profili ta' konċentrazzjoni mhux marbuta u ħin simili għal dawk fil-plażma b'konċentrazzjonijiet massimi mhux marbuta ta' 1.0 mg/l (medja ġeometrika) li ntlaħqet madwar 1.8 h wara doża fil-vini.
English: 400 mg moxifloxacin, infused once daily.
Maltese: 400 mg moxifloxacin, bħala infużjoni darba kuljum.
English: Infused at a constant flow rate over 60 minutes.
Maltese: It-tabib tiegħek għandu jiżgura li l-infużjoni tingħata b'rata kostanti fuq medda ta' 60 minuta.
English: Moxifloxacin is eliminated from plasma with a mean terminal half life of approximately 12 hours.
Maltese: Moxifloxacin huwa eliminat mill-plażma half-life terminali medja ta' madwar 12-il siegħa.
English: Liver Common:
Maltese: Widna Rari:
English: Ringing/noise in the ears Cardiovascular System Common:
Maltese: Żanżin/ħoss fil-widnejn Sistema kardjovaskulari Komuni:
English: Concomitant administration of charcoal with a dose of 400 mg oral or intravenous moxifloxacin will reduce systemic availability of the drug by more than 80% or 20% respectively.
Maltese: L-għoti ta' faħam flimkien ma' doża orali jew fil-vini ta' 400 mg moxifloxacin tnaqqas id-disponibilità sistemika tal-mediċina b'aktar minn 80% jew 20% rispettivament.