FrancophonIA/ELRC3.0 huggingface dataset:
English: The highest daily intravenous dose administered in clinical studies was 1200 mg; the patients who receive this dose did not have any adverse drug reactions or notable clinical laboratory test findings during the study.
Croatian: Najviša dnevna intravenska doza primijenjena u kliničkim ispitivanjima bila je 1200 mg; bolesnici koji su primili tu dozu tijekom ispitivanja nisu imali niti jednu nuspojavu ili značajan nalaz laboratorijskih pretraga.
English: If a common intravenous line is being used to administer other medicinal products in addition to Quofenix the line should be flushed before and after each Quofenix infusion with sodium chloride 9 mg/ml (0.9%) solution for injection or D5W.
Croatian: Ako se koristi ista intravenska linija za primjenu drugih lijekova uz Quofenix, linija se treba isprati prije i nakon svake infuzije Quofenixa otopinom natrijeva klorida za injekcije od 9 mg/ml (0,9%) ili sa D5W.
English: The half-life of oral delafloxacin is approximately 14 hours.
Croatian: Poluvijek peroralnog delafloksacina je približno 14 sati.
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for delafloxacin are as follows:
Croatian: Granične vrijednosti minimalne inhibitorne koncentracije (MIK) koje je odredio Europski odbor za testiranje osjetljivosti na antimikrobna sredstva (engl.
English: There is limited experience in patients aged > 75 years.
Croatian: Ograničeno je iskustvo u bolesnika u dobi
English: Clostridioides difficile-associated disease has been reported in users of nearly all systemic antibacterial medicinal products, with severity ranging from mild diarrhoea to fatal colitis.
Croatian: Bolest povezana s Clostridioides difficile prijavljena je kod korisnika gotovo svih sistemskih antibakterijskih lijekova, te mogu varirati u težini od blagog proljeva do kolitisa sa smrtnim ishodom.
English: Patients with known hypersensitivity to delafloxacin or other fluoroquinolones must not take Quofenix (see section 4.3).
Croatian: Bolesnici s poznatom preosjetljivošću na delafloksacin ili druge fluorokinolone ne smiju uzimati Quofenix (vidjeti dio 4.3).
English: If you take more Quofenix than you should
Croatian: Ako uzmete više Quofenixa nego što ste trebali
English: Pack-size: 10 vials.
Croatian: Pakiranje: 10 bočica.
English: Infection of the bowel (Clostridioides difficile infection) is an uncommon side effect that may affect up to 1 in 100 people.
Croatian: Infekcija crijeva (infekcija s Clostridioides difficile) je manje česta nuspojava koja se može javiti u manje od 1
English: The mean systemic exposure (AUC) increased 2.2-fold, 5.3-fold, 8.5-fold and 29.8-fold for patients with moderate impairment, severe impairment and ESRD with and without haemodialysis after dosing, respectively compared to the normal control group.
Croatian: Srednja vrijednost sistemske izloženosti (AUC) povećala se 2,2 puta, 5,3 puta, 8,5 puta odnosno 29,8 puta kod bolesnika s umjerenim oštećenjem, teškim oštećenjem i ESRD-om sa i bez hemodijalize nakon doziranja u odnosu na normalnu kontrolnu skupinu.
English: This medicine contains 175 mg of sodium (main component of cooking salt) in each vial.
Croatian: Ovaj lijek sadrži 175 mg natrija (glavni sastojak kuhinjske soli) u jednoj bočici.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALUMINIUM/ALUMINIUM BLISTER (TABLETS)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP ALUMINIJ/ALUMINIJ BLISTER /TABLETE
English: Peak plasma delafloxacin concentrations are achieved at the end of the 1 hour intravenous infusion.
Croatian: Vršna koncentracija delafloksacina u plazmi postiže se na kraju intravenske infuzije u trajanju od 1 sata.
English: Central Nervous System Effects
Croatian: Učinci na središnji živčani sustav
English: Patients with toxic shock, neutropenia (neutrophil counts <500 cells/mm3) or severely immunocompromised patients were not included in the studies.
Croatian: Bolesnici s toksičnim šokom, neutropenijom (broj neutrofila < 500 stanica/mm3) ili teško imunokompromitirani bolesnici nisu bili uključeni u ispitivanja.
English: • Inflammation of joints, pain in hands or feet, back pain, muscle spasm
Croatian: • upala zglobova, bolovi u šakama ili stopalima, bolovi u leđima, mišićni grčevi
English: Intravenous use after reconstitution and dilution
Croatian: Intravenska primjena nakon rekonstitucije i razrjeđivanja
English: Unit dose laminated aluminium/aluminium foil blisters.
Croatian: Blisteri s jediničnom dozom, laminirani aluminij/aluminijska folija.
English: • If you are allergic to any other fluoroquinolone or quinolone antibacterial medicine.
Croatian: • ako ste alergični na bilo koji drugi fluorokinolonski ili kinolonski antibakterijski lijek.
English: • Allergic skin reaction
Croatian: • alergijska kožna reakcija
English: The most common adverse drug reactions reported in ABSSSI Phase 2 and 3 studies involving 868 patients exposed to delafloxacin, intravenous or oral formulation, were diarrhoea and nausea (6.91% and 7.83%, respectively) which were mild to moderate in intensity.
Croatian: Najčešće nuspojave prijavljene u ispitivanjima ABSSSI faze 2 i 3 u koja je bilo uključeno 868 bolesnika izloženih delafloksacinu, intravenskom ili peroralnom obliku, bile su proljev i mučnina (6,91% odnosno 7,83%) koje su bile blage do umjerene težine.
English: Quofenix will be given to you by a nurse or doctor via an infusion (drip) into a vein.
Croatian: Quofenix će Vam u venu putem infuzije primijeniti medicinska sestra ili liječnik.
English: No effects were detected on rat male and female fertility at a level of exposure about 5-fold higher than that observed in humans.
Croatian: Nisu opaženi učinci na plodnost mužjaka i ženki štakora pri razini izloženosti oko 5 puta većoj nego u ljudi.
English: Clinically significant gender-related differences in delafloxacin pharmacokinetics have not been observed in healthy subjects or in patients with ABSSSI.
Croatian: Nisu uočene klinički značajne razlike povezane sa spolom u farmakokinetici delafloksacina u zdravih ispitanika ili bolesnika s ABSSSI-om.
English: Quofenix is a beige to mottled beige, oblong biconvex tablets, with RX3341 debossed on one side.
Croatian: Quofenix su duguljaste, bikonveksne tablete bež do pjegavo bež boje, s oznakom RX3341 utisnutom s jedne strane.
English: This medicinal product contains 175 mg sodium per vial, equivalent to 8.8% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Ovaj lijek sadrži 175 mg natrija po bočici, što odgovara 8,8% maksimalnog dnevnog unosa od 2 g natrija prema preporukama SZO za odraslu osobu.
English: This medicinal product contains sulfobutylbetadex sodium.
Croatian: Ovaj lijek sadrži sulfobutilbetadeksnatrij.
English: No dose adjustment is necessary in patients with mild to moderate renal impairment (CrCl of ≥30 mL/min).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega (klirens kreatinina, CrCl ≥30 ml/min).
English: Resistance to fluoroquinolones, including delafloxacin, can occur due to mutations in defined regions of the target bacterial enzymes topoisomerase IV and DNA gyrase referred to as Quinolone-Resistance Determining Regions (QRDRs), or through other resistance mechanisms such as efflux mechanisms.
Croatian: Rezistencija na fluorokinolone, uključujući delafloksacin, može nastati zbog mutacija na određenim mjestima ciljnih bakterijskih enzima topoizomeraze IV i DNK giraze, takozvanih determinirajućih regija za rezistenciju na kinolone (engl.
English: Women of childbearing potential have to use effective contraception during treatment with delafloxacin.
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja delafloksacinom.
English: The 300-mg IV formulation and 450 mg tablet are bioequivalent with regard to total exposure (AUC).
Croatian: Intravenska formulacija od 300 mg i tableta od 450 mg su bioekvivalentne s obzirom na ukupnu izloženost (AUC).
English: • You have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e. g. connective tissue disorders such as Marfan syndrome, or vascular Ehlers-Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or known atherosclerosis).
Croatian: • ako u obiteljskoj povijesti bolesti imate aneurizmu aorte ili disekciju aorte, ili druge rizične faktore ili stanja zbog kojih ste skloniji pojavi aneurizme ili disekcije (npr. poremećaji vezivnog tkiva kao što je Marfanov sindrom ili vaskularni oblik Ehlers-Danlosova sindroma ili vaskularni poremećaji kao što je Takayasuov arteritis, arteritis orijaških stanica, Behcetova bolest, visoki krvni tlak ili poznata ateroskleroza).
English: Following intravenous use of 300 mg delafloxacin every 12 hours, steady state concentrations are achieved after approximately 3-5 days with about 10% accumulation after multiple administrations.
Croatian: Nakon intravenske primjene 300 mg delafloksacina svakih 12 sati, koncentracije u stanju dinamičke ravnoteže postignute su približno nakon 3-5 dana, s oko 10% akumulacije nakon višekratne primjene.
English: Clinical response to treatment and renal function should be closely monitored in these patients.
Croatian: U tih je bolesnika potrebno pozorno pratiti klinički odgovor na liječenje i funkciju bubrega.
English: The highest daily oral dose administered in clinical studies was 1600 mg; the patients who receive this dose did not have any adverse drug reactions or notable clinical laboratory test findings during the study.
Croatian: Najviša dnevna peroralna doza primijenjena u kliničkim ispitivanjima bila je 1600 mg; bolesnici koji su primili tu dozu tijekom ispitivanja nisu imali niti jednu nuspojavu ili značajan nalaz laboratorijskih pretraga.
English: • Reduced kidneys function
Croatian: • smanjena funkcija bubrega
English: Beige to mottled beige, oblong biconvex tablets of approximately 10 mm width x 21 mm length, with RX3341 debossed on one side.
Croatian: Duguljaste, bikonveksne tablete bež do pjegavo bež boje, širine otprilike 10 mm i duljine 21 mm, s oznakom RX3341 utisnutom s jedne strane.
English: The glucuronidation of delafloxacin is mediated mainly by UGT1A1,UGT1A3 and UGT2B15.
Croatian: Glukuronidacija delafloksacina posredovana je uglavnom s UGT1A1, UGT1A3 i UGT2B15.
English: Following single intravenous (300 mg) administration to patients with mild, moderate, or severe renal impairment or ESRD on haemodialysis with and without haemodialysis after dosing, mean total exposure (AUCt) were 1.3, 1.7, 2.1, 3.5 and 4.1-fold higher than values for matched control subjects.
Croatian: Nakon jednokratne intravenske (300 mg) primjene u bolesnika s blagim, umjerenim ili teškim oštećenjem bubrežne funkcije ili ESRD-om na hemodijalizi, sa ili bez hemodijalize nakon doziranja, srednja vrijednost ukupne izloženosti (AUCt) bila je 1,3; 1,7; 2,1; 3,5 i 4,1 puta veća nego kod uparenih kontrolnih ispitanika.
English: • Urinary tract infection
Croatian: • infekcija urinarnog trakta
English: Hypersensitivity to any fluoroquinolone or quinolone antibacterial medicinal product.
Croatian: Preosjetljivost na bilo koji fluorokinolonski ili kinolonski antibakterijski lijek.
English: • You have had tendon problems during previous treatment with a fluoroquinolone or quinolone antibiotic.
Croatian: • ako ste imali problema s tetivama tijekom prethodnog liječenja fluorokinolonskim ili kinolonskim antibiotikom.
English: Breast-feeding is contraindicated during treatment with delafloxacin.
Croatian: Dojenje je kontraindicirano tijekom liječenja delafloksacinom.
English: Quofenix is not recommended in patients with End Stage Renal Disease (ESRD).
Croatian: Quofenix se ne preporučuje kod bolesnika s bubrežnom bolešću u završnom stadiju (ESRD).
English: The 450-mg tablet and 300-mg IV formulations are bioequivalent with regard to total exposure (AUC).
Croatian: Tableta od 450 mg i intravenska formulacija od 300 mg su bioekvivalentne s obzirom na ukupnu izloženost (AUC).
English: No clinically meaningful changes in delafloxacin Cmax and AUC∞ were observed, following administration of a single 300 mg intravenous dose of delafloxacin into patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B and C) compared to matched healthy control subjects.
Croatian: Nisu primijećene klinički značajne razlike u Cmax i AUC∞ delafloksacina nakon primjene jednokratne intravenske doze od 300 mg delafloksacina bolesnicima s blagim, umjerenim ili teškim oštećenjem funkcije jetre (Child-Pugh klase A, B i C) u usporedbi s primjenom uparenim kontrolnim zdravim ispitanicima.
English: If an anaphylactic reaction to Quofenix occurs, the medicinal product should be discontinued immediately and appropriate therapy should be instituted.
Croatian: Ako nastupi anafilaktička reakcija na Quofenix, treba odmah prekinuti uzimanje lijeka i započeti odgovarajuće liječenje.
English: A. Menarini Pharma GmbH.
Croatian: Menarini Pharma GmbH.
English: If you are given more Quofenix than you should
Croatian: Ako primite više Quofenixa nego što ste trebali
English: The use of delafloxacin should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8).
Croatian: Primjenu delafloksacina treba izbjegavati u bolesnika koji su prije imali ozbiljne nuspojave kad su primjenjivali lijekove koji sadrže kinolon ili fluorokinolon (vidjeti dio 4.8).
English: Talk to your doctor or pharmacist or nurse before taking Quofenix if:
Croatian: Obavijestite svog liječnika ili ljekarnika ili medicinsku sestru prije nego primite Quofenix:
English: - The active substance is delafloxacin.
Croatian: - Djelatna tvar je delafloksacin.
English: What you need to know before you take Quofenix 3.
Croatian: Što morate znati prije nego primite Quofenix 3.
English: Quofenix contains cyclodextrin
Croatian: Quofenix sadrži ciklodekstrin
English: The reconstituted vial contains 300 mg per 12 mL of delafloxacin as a clear yellow to amber coloured solution.
Croatian: Rekonstituirana bočica sadrži 300 mg u 12 ml delafloksacina, kao bistru žutu do jantarno obojanu otopinu.
English: Quofenix must not be used in women of childbearing potential not using contraception.
Croatian: Quofenix se ne smije primijeniti u žena koje mogu zatrudnjeti a ne koriste kontracepciju.
English: These severe reactions are uncommon side effects that may affect up to 1 in 100 people.
Croatian: Ove teške reakcije su manje česte nuspojave koje se mogu javiti u manje od 1 na 100 osoba.
English: • Flushing (e.g. redness of the face or neck)
Croatian: • navale crvenila (npr. crvenilo lica ili vrata)
English: Pharmacotherapeutic group: Antibacterials for systemic use, fluoroquinolones, ATC code: J01MA23 Mechanism of action
Croatian: fluorokinoloni, ATK oznaka: J01MA23
English: Quofenix must be reconstituted under aseptic conditions, using 10.5 mL of dextrose 50 mg/ml (5%) solution for injection (D5W) or sodium chloride 9 mg/ml (0.9%) solution for injection for each 300 mg vial.
Croatian: Quofenix se mora rekonstituirati u aseptičkim uvjetima, koristeći 10,5 ml otopine glukoze za injekciju od 50 mg/ml (5%) (engl. dextrose 5% in water, D5W) ili otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%) za svaku bočicu od 300 mg.
English: Description of selected adverse drug reactions
Croatian: Opis odabranih nuspojava
English: • Decrease of special blood cells necessary for blood clotting
Croatian: • snižen broj posebnih krvnih stanica za zgrušavanje krvi
English: Musculoskeletal and connective tissue disorders*
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva*
English: Sinus tachycardia Palpitations Bradycardia
Croatian: Srčani poremećaji sinusna tahikardija palpitacije bradikardija
English: This severe reaction is an uncommon side effect that may affect up to 1 in 100 people.
Croatian: Ova teška reakcija je manje česta nuspojava i može se javiti u manje od 1 na 100 osoba.
English: Each vial contains 175 mg of sodium.
Croatian: Jedna bočica sadrži 175 mg natrija.
English: Via Sette Santi 3, 50131 Florence, Italy
Croatian: Menarini - Industrie Farmaceutiche Riunite - s.r.l. Via Sette Santi 3, 50131 Firenca, Italija
English: Quofenix must not be used if you are pregnant or breast-feeding.
Croatian: Quofenix se ne smije uzimati ako ste trudni ili dojite.
English: If you stop taking Quofenix
Croatian: Ako prestanete uzimati Quofenix
English: Post-marketing serious adverse reactions, including deaths and requirement for ventilator support, have been associated with fluoroquinolone use in persons with myasthenia gravis.
Croatian: Ozbiljne nuspojave zabilježene nakon stavljanja lijeka u promet, koje su uključivale smrt i potrebu za respiratornom potporom, smatrale su se povezane s primjenom fluorokinolona u bolesnika s miastenijom gravis.
English: Therefore, delafloxacin should be used with caution in these patients.
Croatian: Stoga se u ovih bolesnika delafloksacin mora primjenjivati s oprezom.
English: Tendinitis and tendon rupture
Croatian: Tendinitis i ruptura tetive
English: (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue and severe sleep disorders.
Croatian: poremećaje osjeta uključujući oštećenje vida, osjeta okusa i mirisa te sluha, depresiju, narušeno pamćenje, jak umor i teške poremećaje spavanja.
English: Vertigo Tinnitus
Croatian: vrtoglavica tinitus
English: The recommended dose is 450 mg oral every 12 hours for a total duration of 5 to 14 days at the discretion of your doctor.
Croatian: Preporučena doza je 450 mg kroz usta svakih 12 sati, ukupnog trajanja liječenja 5 do 14 dana, prema odluci Vašeg liječnika.
English: No dose adjustment is necessary in patients with mild to severe renal impairment (see section 4.4 and 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim do teškim oštećenjem funkcije bubrega (vidjeti dijelove 4.4 i 5.2).
English: • High blood glucose levels
Croatian: • visoka razina glukoze u krvi
English: Following oral administration of 450 mg of delafloxacin every 12 hours, steady state concentrations are achieved after approximately 5 days with about 36% accumulation after multiple administrations.
Croatian: Nakon peroralne primjene 450 mg delafloksacina svakih 12 sati, koncentracije u stanju dinamičke ravnoteže postignute su približno nakon 5 dana, s oko 36% akumulacije nakon višekratne primjene.
English: Quofenix contains sodium
Croatian: Quofenix sadrži natrij
English: • Fungal infection
Croatian: • gljivična infekcija
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNIT VIAL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: You should not take fluoroquinolone/quinolone antibacterial medicines, including Quofenix, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone.
Croatian: Ne smijete uzimati fluorokinolonski/kinolonski antibiotik, uključujući Quofenix, ako ste u prošlosti imali bilo kakvu ozbiljnu nuspojavu kad ste uzimali kinolon ili fluorokinolon.
English: If you forget to take Quofenix
Croatian: Ako ste zaboravili uzeti Quofenix
English: If you have any further questions on the use of this medicine, ask your doctor.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se Vašem liječniku.
English: If you experience any of these side effects after receiving Quofenix, contact your doctor immediately prior to continuing treatment.
Croatian: Ako osjetite bilo koju od ovih nuspojava nakon primanja lijeka Quofenix, odmah se obratite svom liječniku prije nego što nastavite s liječenjem.
English: Delafloxacin should be used when the benefits of treatment exceed the risks in patients with known or suspected CNS disorders (e.g. severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold.
Croatian: Delafloksacin se smije primjenjivati kada je korist liječenja veća od rizika u bolesnika s poznatim poremećajima središnjeg živčanog sustava ili se na njih sumnja (npr. teška cerebralna ateroskleroza, epilepsija) ili u prisustvu drugih faktora rizika koji mogu predisponirati za napadaje ili sniziti prag za napadaje.
English: Each vial contains 2480 mg of sulfobutylbetadex sodium.
Croatian: Jedna bočica sadrži 2480 mg sulfobutilbetadeksnatrija.
English: Hypersensitivity (see section 4.4) Seasonal allergy
Croatian: Poremećaji imunološkog sustava preosjetljivost (vidjeti dio 4.4) sezonska alergija
English: In patients with moderate to severe renal impairment, accumulation of cyclodextrins occurs.
Croatian: U bolesnika s umjerenom do teškom bubrežnom disfunkcijom može doći do akumulacije ciklodekstrina.
English: If you experience any of these side effects after taking Quofenix, contact your doctor immediately prior to continuing treatment.
Croatian: Ako osjetite bilo koju od ovih nuspojava nakon uzimanja lijeka Quofenix, odmah se obratite svom liječniku prije nego što nastavite s liječenjem.
English: • Change in taste
Croatian: • poremećen osjet okusa
English: Quofenix powder for concentrate for solution for infusion is provided in 20 ml clear glass vial.
Croatian: Quofenix prašak za koncentrat za otopinu za infuziju dolazi u prozirnoj staklenoj bočici od 20 ml.
English: What you need to know before you are given Quofenix You must not be given Quofenix:
Croatian: Što morate znati prije nego primite Quofenix Ne smijete primiti Quofenix:
English: The recommended regimen of delafloxacin is 450 mg oral every 12 hours for a total duration of 5 to 14 days at the discretion of the physician.
Croatian: Preporučeni režim delafloksacina je 450 mg peroralno svakih 12 sati, ukupnog trajanja liječenja 5 do 14 dana, prema odluci liječnika.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (VIALS)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (BOČICE)
English: You should not be given fluoroquinolone/quinolone antibacterial medicines, including Quofenix, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone.
Croatian: Ne smijete primiti fluorokinolonski/kinolonski antibiotik, uključujući Quofenix, ako ste u prošlosti imali bilo kakvu ozbiljnu nuspojavu kad ste uzimali kinolon ili fluorokinolon.
English: - The other ingredients are cellulose microcrystalline, povidone, crospovidone, sodium hydrogen carbonate, sodium dihydrogen phosphate monohydrate, citric acid, magnesium stearate.
Croatian: - Druge pomoćne tvari su celuloza, mikrokristalična, povidon, krospovidon, natrijev hidrogenkarbonat, natrijev dihidrogenfosfat hidrat, citratna kiselina, magnezijev stearat
English: • Muscle weakness in the extremities
Croatian: • slabost u mišićima udova
English: 20 ml clear type I glass vials outfitted with 20 mm type I rubber stoppers and 20 mm flip-off caps.
Croatian: Prozirna bočica od 20 ml od stakla tipa I, zatvorena čepom od 20 mm od gume tipa
English: Exacerbation of myasthenia gravis
Croatian: Egzacerbacija miastenije gravis
English: Before taking this medicine
Croatian: Prije uzimanja ovog lijeka
English: After reconstitution, each ml contains 25 mg of delafloxacin.
Croatian: Nakon rekonstitucije, jedan ml sadrži 25 mg delafloksacina.
English: Following a single oral (400 mg) administration to patients with mild, moderate or severe renal impairment, mean total exposure (AUCt) was about 1.5-fold higher for subjects with moderate and severe renal impairment compared with healthy subjects, whereas total systemic exposures were comparable to subjects with mild renal impairment.
Croatian: Nakon jednokratne peroralne (400 mg) primjene u bolesnika s blagim, umjerenim ili teškim oštećenjem bubrežne funkcije, srednja vrijednost ukupne izloženosti (AUCt) bila je oko 1,5 puta veća kod ispitanika s umjerenim i teškim oštećenjem bubrežne funkcije u usporedbi sa zdravim ispitanicima, dok je ukupna sistemska izloženost bila usporediva kod ispitanika s blagim oštećenjem bubrežne funkcije.