FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy has been demonstrated in clinical studies against the following pathogens that were susceptible to delafloxacin in vitro.
Croatian: Djelotvornost je dokazana u kliničkim ispitivanjima protiv sljedećih patogena koji su bili osjetljivi na delafloksacin in vitro.
English: A tendon is the cord that joins your muscle to your skeleton.
Croatian: Tetiva je traka koja povezuje Vaše mišiće s Vašim kostima.
English: However, delafloxacin should not be co-administered with any solution containing multivalent cations, e.g. magnesium, through the same intravenous line (see section 4.2 and
Croatian: Međutim, delafloksacin se ne smije istodobno primjenjivati s bilo kojom otopinom koja sadrži multivalentne katione, npr. magnezij, putem iste intravenske linije (vidjeti dijelove 4.2 i 6.2).
English: What Quofenix is and what it is used for
Croatian: Što je Quofenix i za što se koristi
English: Known fluoroquinolones-associated possible interactions shall be considered.
Croatian: Treba imati na umu poznate moguće interakcije fluorokinolona.
English: - Drop in blood pressure; blurred vision; dizziness.
Croatian: Pad krvnog tlaka; zamagljeni vid; omaglica.
English: Quofenix must not be co-infused with other medications.
Croatian: Quofenix se ne smije dati u istoj infuziji s drugim lijekovima.
English: Psychiatric disorders*
Croatian: Psihijatrijski poremećaji*
English: There are no data available on severe cases of hypoglycaemia resulting in coma or death after delafloxacin use.
Croatian: Nema dostupnih podataka o teškim slučajevima hipoglikemije koji su doveli do kome ili smrti nakon primjene delafloksacina.
English: These may be signs of an infection of the bowel, which should not be treated with diarrhoea medicines that stop your bowels from moving.
Croatian: Ovo mogu biti znakovi infekcije crijeva koja ne smije biti liječena lijekovima za proljev koji zaustavljaju rad crijeva.
English: The recommended dose is 300 mg delafloxacin every 12 hours administered over 60 minutes by intravenous infusion.
Croatian: Preporučena doza je 300 mg delafloksacina svakih 12 sati primijenjena intravenskom infuzijom tijekom 60 minuta.
English: Each tablet contains 39 mg of sodium.
Croatian: Jedna tableta sadrži 39 mg natrija.
English: • After reconstitution and dilution, Quofenix is to be administered via intravenous infusion, using a total infusion time of 60 minutes.
Croatian: • Nakon rekonstitucije i razrjeđivanja, Quofenix treba primijeniti intravenskom infuzijom, uz ukupno trajanje infuzije od 60 minuta.
English: Light yellow to tan cake, which may exhibit cracking and shrinkage and slight variation in texture and colour.
Croatian: Kolačić svjetlo žute boje do boje pudera, mogu se stvarati pukotine, skupljanje i može doći do blagih promjena teksture i boje.
English: There are no or limited amount of data from the use of delafloxacin in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni delafloksacina u trudnica ograničeni.
English: Abnormal dreams
Croatian: • neuobičajeni snovi
English: • You have or may have problems with the central nervous system (e.g. severe cerebral arteriosclerosis, epilepsy) or have other risk factors that may put you at more risk of having seizures (fits).
Croatian: • ako imate ili biste mogli imati probleme sa središnjim živčanim sustavom (npr. teška cerebralna ateroskleroza, epilepsija) ili imate druge čimbenike rizika zbog kojih možete imati veći rizik za pojavu napadaja.
English: Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis.
Croatian: Fluorokinoloni imaju blokirajuće djelovanje na neuromuskularnu spojnicu i mogu pogoršati mišićnu slabost kod miastenije gravis.
English: Following a single oral dose of 14C-labeled delafloxacin, 50% of the radioactivity is excreted in the urine as unchanged delafloxacin and glucuronide metabolites and 48% is excreted unchanged in the faeces.
Croatian: Nakon jednokratne peroralne doze delafloksacina označenog s 14C, 50% radioaktivnosti se izlučuje urinom kao nepromijenjeni delafloksacin i kao metaboliti glukuronidi, a 48% se izlučuje fecesom u nepromijenjenom obliku.
English: Delafloxacin may be administered with or without food as total systemic exposure (AUC∞) is unchanged between fasted and fed (high-fat, high-calorie) conditions.
Croatian: Delafloksacin može biti primijenjen sa ili bez hrane jer je ukupna sistemska izloženost (AUC∞) nepromijenjena između stanja natašte i stanja sitosti (punomasni,
English: If you feel sudden, severe pain in your abdomen, chest or back, go immediately to an emergency room.
Croatian: Ako osjetite iznenadnu jaku bol u trbuhu, prsnom košu ili leđima, odmah idite na hitnu pomoć.
English: A. Menarini Pharmaceuticals Ireland Ltd Tel: +353 1 284 6744
Croatian: Menarini Pharmaceuticals Ireland Ltd Tel: +353 1 284 6744
English: Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping Quofenix therapy.
Croatian: Upala i puknuća tetiva mogu nastati unutar prvih 48 sati liječenja i čak do nekoliko mjeseci nakon prestanka terapije lijekom Quofenix.
English: After single intravenous dose of 14C-labeled delafloxacin, 65% of the radioactivity is excreted in the urine and 28% is excreted in the faeces.
Croatian: Nakon jednokratne intravenske doze delafloksacina označenog s 14C, 65% radioaktivnosti se izlučuje urinom i 28% se izlučuje fecesom.
English: In rats foetal effects occurred at a level of exposure exceeding about 2fold that observed in humans based on the AUC, but in rabbits, a species known to be extremely sensitive to maternal toxicity of antibacterial drugs, the effects on foetuses were recorded at levels of exposure well below that observed in humans.
Croatian: U štakora su se fetalni učinci pojavili pri razini izloženosti koja je prelazila 2 puta veću izloženost od one opažene u ljudi temeljene na AUC-u, ali u kunića, vrsti koja je poznata po izuzetnoj osjetljivosti na maternalnu toksičnost antibakterijskih lijekova, učinak na fetuse zabilježen je pri razinama izloženosti daleko manjim od izloženosti u ljudi.
English: Prolonged, disabling and potentially irreversible serious side effects
Croatian: Dugotrajne, onesposobljavajuće i potencijalno nepopravljive ozbiljne nuspojave
English: Tell your doctor or nurse immediately if you are concerned that you may have missed a dose.
Croatian: Odmah obavijestite Vašeg liječnika ili medicinsku sestru ako se brinete da ste možda propustili primiti dozu lijeka.
English: Before initiating therapy with Quofenix, careful inquiry should be made about previous hypersensitivity reactions to other quinolone or fluoroquinolone antibacterial medicinal products.
Croatian: Prije početka liječenja Quofenixom treba prikupiti detaljne podatke o prethodnim reakcijama preosjetljivosti na druge kinolonske ili fluorokinolonske antibakterijske lijekove.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of delafloxacin/metabolites in milk (see section 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci u životinja pokazuju da se delafloksacin/metaboliti izlučuju u mlijeko (vidjeti dio 5.3).
English: No dosage adjustment is necessary (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu (vidjeti dio 5.2).
English: Fluoroquinolone antibiotics, including Quofenix, may cause levels of glucose in the blood to rise too high or fall too low.
Croatian: Fluorokinolonski antibiotici, uključujući Quofenix, mogu uzrokovati razine glukoze u krvi koje su ili previsoke ili preniske.
English: This medicine contains 39 mg of sodium (main component of cooking salt) in each tablet.
Croatian: Ovaj lijek sadrži 39 mg natrija (glavni sastojak kuhinjske soli) u jednoj tableti.
English: Glucuronidation of delafloxacin is the primary metabolic pathway with oxidative metabolism representing <1% of an administered dose.
Croatian: Glukuronidacija delafloksacina je primarni metabolički put, a oksidativni metabolizam prolazi <1%
English: In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.
Croatian: U slučajevima iznenadne boli u abdomenu, prsištu ili leđima, bolesnike je potrebno savjetovati da se odmah obrate liječniku u hitnoj medicinskoj službi.
English: In diabetic patients, careful monitoring of blood glucose is recommended.
Croatian: U bolesnika s dijabetesom preporučuje se pažljivo praćenje razine glukoze u krvi.
English: Some adverse drug reactions (e.g. dizziness, headache, visual disorders) may impair the patient's ability to concentrate and react, and therefore may constitute a risk in situations where the patient operates an automobile or machinery or engages in other activities requiring mental alertness and coordination.
Croatian: Neke nuspojave (npr. omaglica, glavobolja, poremećaji vida) mogu oslabiti bolesnikovu sposobnost koncentracije i reagiranja te, stoga, predstavljaju rizik u situacijama kada bolesnik upravlja vozilima ili strojevima ili je uključen u druge aktivnosti koje zahtijevaju mentalnu pozornost i koordinaciju.
English: Millmount Healthcare Block-7, City North Business Campus, Stamullen, Co. Meath Ireland or
Croatian: MillMount Healthcare Block-7, City North Business Campus, Stamullen, Co.
English: MillMount Healthcare Block-7, City North Business Campus, Stamullen, Co. Meath Ireland or
Croatian: Millmount Healthcare Block-7, City North Business Campus, Stamullen, Co.
English: Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with other fluoroquinolones.
Croatian: Zabilježeni su slučajevi buloznih kožnih reakcija poput Stevens-Johnsonovog sindroma ili toksične epidermalne nekrolize tijekom liječenja drugim fluorokinolonima.
English: Quofenix is contraindicated in children and adolescents (see section 4.3).
Croatian: Quofenix je kontraindiciran u djece i adolescenata (vidjeti dio 4.3).
English: Do not take any medicine to treat your diarrhoea without first checking with your doctor.
Croatian: Ne uzimajte nikakve lijekove za liječenje proljeva a da se prethodno niste posavjetovali s Vašim liječnikom.
English: No adverse effects were seen in rats at exposures about 2-fold higher than humans, or in dogs at exposures approximately equal to humans.
Croatian: Nisu uočeni štetni učinci kod štakora pri izloženosti oko 2 puta većoj nego kod ljudi, ili kod pasa pri izloženosti približno istoj kao kod ljudi.
English: Pack sizes of 10 x1, 20 x1, 30 x1, 50 x1, 60 x1 or 100 x1 tablets.
Croatian: Veličine pakiranja: 10 x 1, 20 x 1, 30 x 1, 50 x 1, 60 x 1 ili 100 x 1 tableta.
English: • Cold sweat
Croatian: • hladni znoj
English: Effect of delafloxacin on other medicinal products
Croatian: Djelovanje delafloksacina na druge lijekove
English: If you might become pregnant you have to use effective contraception during treatment with Quofenix.
Croatian: Ako možete zatrudnjeti, tijekom liječenja Quofenixom morate koristiti učinkovitu kontracepciju.
English: Oral administration of delafloxacin with antacids containing aluminium or magnesium, with sucralfate, with metal cations such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations such as didanosine buffered tablets for oral suspension or the paediatric powder for oral solution, may substantially interfere with the absorption of delafloxacin, resulting in systemic concentrations considerably lower than desired.
Croatian: Peroralna primjena delafloksacina s antacidima koji sadrže aluminij ili magnezij, sa sukralfatom, s metalnim kationima poput željeza ili s multivitaminima koji sadrže željezo ili cink, ili s formulacijama koje sadrže dvovalentne i trovalentne katione poput didanozina u obliku puferiranih tableta za oralnu suspenziju ili pedijatrijskog praška za oralnu otopinu, mogu bitno interferirati s apsorpcijom delafloksacina, što rezultira značajno nižim sistemskim koncentracijama od željenih.
English: A. Menarini Portugal - Farmacêutica, S.A. Tel: +351 210 935 500
Croatian: Menarini Portugal - Farmacêutica, S.A. Tel: +351 210 935 500
English: Dosing in patients with severe renal impairment (CrCl of <30 mL/min) should be decreased to 200 mg intravenously every 12 hours; alternatively patients should receive 450 mg delafloxacin orally every 12 hours (see section 4.4 and 5.2).
Croatian: (CrCl <30 ml/min) treba smanjiti na 200 mg intravenski svakih 12 sati; alternativno bolesnici trebaju dobiti 450 mg delafloksacina peroralno svakih 12 sati (vidjeti dijelove 4.4 i 5.2).
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE
English: As delafloxacin is excreted in milk, severe toxicity was observed in newborn rats during lactation when mothers were treated during pregnancy and lactation with delafloxacin at a dose producing a systemic exposure about 5-fold higher than observed in humans.
Croatian: Kako se delafloksacin izlučuje u mlijeko, primijećena je teška toksičnost tijekom dojenja novorođenih štakora kada su majke tijekom trudnoće i dojenja bile liječene delafloksacinom u dozi koja je proizvela sistemsku izloženost oko 5 puta veću nego u ljudi.
English: Quofenix is an antibiotic that contains the active substance delafloxacin.
Croatian: Quofenix je antibiotik koji sadrži djelatnu tvar delafloksacin.
English: Nonclinical studies conducted with delafloxacin in rats do not indicate harmful effects with respect to fertility or reproductive performance (see section 5.3).
Croatian: Neklinička ispitivanja provedena s delafloksacinom u štakora ne ukazuju na štetne učinke na plodnost ili sposobnost reprodukcije (vidjeti dio 5.3).
English: You will be given one infusion of Quofenix, containing 300 mg of the medicine, twice a day between 5 and 14 days at the discretion of your doctor.
Croatian: Primiti ćete infuziju lijeka Quofenix, koja sadrži 300 mg lijeka, dvaput dnevno, tijekom 5 do 14 dana,
English: • You may have a severe skin reaction such as blistering or lesion.
Croatian: • ako imate teške kožne reakcije poput stvaranja mjehura ili rana.
English: In embryo-fetal development studies carried out in rats and rabbits, delafloxacin was devoid of teratogenic effects but induced foetal growth retardation and ossification delays at levels of dose producing maternal toxicity.
Croatian: U ispitivanjima embriofetalnog razvoja provedenim na štakorima i kunićima, delafloksacin nije imao teratogene učinke, ali je inducirao retardaciju fetalnog rasta i kašnjenje osifikacije, pri razinama doze koja je dovodila do maternalne toksičnosti.
English: • Blood in urine
Croatian: • krv u mokraći
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, tell your doctor before you are taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: Therefore, no dosage adjustment is necessary.
Croatian: Stoga nije potrebna prilagodba doze.
English: Treatment of these patients with delafloxacin should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment (see also section 4.3).
Croatian: Liječenje tih bolesnika delafloksacinom smije se započeti samo ako nema drugih terapijskih mogućnosti te nakon pažljive procjene omjera koristi i rizika (vidjeti također dio 4.3).
English: It is available in perforated unit dose blister pack which contains blisters of 10x1 tablets into pack size of 10,20,30,50, 60 or 100 tablets per carton.
Croatian: Dostupan je u pakiranju s perforiranim blisterima s jediničnom dozom koje sadrži blistere s 10x1 tabletom, pakirane u kutije sa 10, 20, 30, 50, 60 ili 100 tableta.
English: If this happens, stop taking Quofenix and inform your doctor immediately in order to prevent the development of potentially irreversible condition.
Croatian: Ako se to dogodi, prestanite uzimati Quofenix i odmah obavijestite svog liječnika kako bi se spriječio razvoj potencijalno nepopravljivih oštećenja.
English: • Prepare the required dose for intravenous infusion by withdrawing the volume of 12 ml for Quofenix 300 mg or 8 ml for Quofenix 200 mg from the reconstituted vial.
Croatian: • Pripremiti potrebnu dozu za intravensku infuziju izvlačeći volumen od 12 ml iz rekonstituirane bočice za Quofenix 300 mg ili 8 ml za Quofenix 200 mg.
English: In repeat dose toxicity studies in rats and dogs, gastrointestinal effects were the main findings: these included dilated cecum (oral only), abnormal stool, and decreased food intake and / or body weight in rats, and emesis, salivation and abnormal stool / diarrhoea in dogs.
Croatian: U ispitivanjima toksičnosti ponovljenih doza na štakorima i psima, glavni nalazi bili su gastrointestinalni učinci, uključujući dilatirani cekum (samo peroralno), abnormalnu stolicu, smanjen unos hrane i/ili tjelesnu težinu u štakora, te emezu, salivaciju i abnormalnu stolicu / proljev u pasa.
English: Long-term carcinogenicity studies have not been conducted with delafloxacin.
Croatian: Nisu provedena dugotrajna ispitivanja kancerogenosti s delafloksacinom.
English: Tell your doctor or nurse immediately if you are concerned that you may have been given too much Quofenix.
Croatian: Odmah obavijestite Vašeg liječnika ili medicinsku sestru ako se brinete da ste možda primili previše lijeka Quofenix.
English: • You have diabetes.
Croatian: • ako imate dijabetes.
English: At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with delafloxacin should be discontinued and alternative treatment should be considered.
Croatian: Kod prvog znaka tendinitisa (npr. bolnog oticanja, upale) treba prekinuti liječenje delafloksacinom i razmotriti drugu mogućnost liječenja.
English: Based on in vitro data on metabolising enzymes and transporters delafloxacin possesses a low potential to alter the disposition of other medicinal products (see section 5.2).
Croatian: Na temelju podataka in vitro o učincima na metabolizirajuće enzime i transportere, delafloksacin ima mali potencijal za mijenjanje dispozicije drugih lijekova (vidjeti dio 5.2).
English: The fAUC24/MIC ratio, as for other quinolone antibiotics, resulted in the pharmacokinetic/ pharmacodynamic parameter most closely associated with the efficacy of delafloxacin.
Croatian: Omjer fAUC24/MIK se, kao i za druge kinolonske antibiotike, pokazao farmakokinetičkim/ farmakodinamičkim parametrom koji je bio najbolje povezan s djelotvornošću delafloksacina.
English: Cases of hypoglycaemic coma have been reported.
Croatian: Prijavljeni su slučajevi hipoglikemijske kome.
English: No clinical trials have been conducted with delafloxacin in paediatric patients.
Croatian: Nisu provedena klinička ispitivanja s delafloksacinom u pedijatrijskih bolesnika.
English: As per fluoroquinolone class patients aged over 60 years are at increased risk for developing severe tendon disorders including tendon rupture (see sections 4.4 and
Croatian: Kao i za druge lijekove iz skupine fluorokinolona, bolesnici stariji od 60 godina imaju veći rizik pojave teških poremećaja tetiva uključujući rupturu tetive (vidjeti dijelove 4.4 i 5.2).
English: It is unknown whether delafloxacin/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se delafloksacin/metaboliti u majčino mlijeko.
English: This medicinal product contains 39 mg sodium per tablet, equivalent to 2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Ovaj lijek sadrži 39 mg natrija po tableti, što odgovara 2% maksimalnog dnevnog unosa od 2 g natrija prema preporukama SZO za odraslu osobu.
English: At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Quofenix, contact your doctor and rest the painful area.
Croatian: Kod prvog znaka boli ili upale tetive (na primjer, u gležnju, zapešću, laktu, ramenu ili koljenu), prestanite uzimati Quofenix, obratite se liječniku i pazite da bolno područje miruje.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (TABLETS)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (TABLETE)
English: Streptococcus oralis, Streptococcus mitis, and Streptococcus sanguinis)
Croatian: Streptococcus oralis, Streptococcus mitis i Streptococcus sanguinis)
English: • Streptococcus mitis group (including Streptococcus cristatus, Streptococcus gordonii,
Croatian: • Skupina Streptococcus mitis (uključujući Streptococcus cristatus, Streptococcus gordonii,
English: The vial contains light yellow to tan cake powder.
Croatian: Bočica sadrži prašak svijetlo žute boje do boje pudera.
English: Paediatric population Quofenix is contraindicated in children and adolescents (see section 4.3).
Croatian: Pedijatrijska populacija Quofenix je kontraindiciran u djece i adolescenata (vidjeti dio 4.3).
English: Delafloxacin pharmacokinetic is comparable in patients with ABSSSI and healthy volunteers.
Croatian: Farmakokinetika delafloksacina usporediva je u bolesnika s ABSSSI-om s farmakokinetikom u zdravih dobrovoljaca.
English: • Blood test alteration related to kidney or liver function (blood alkaline phosphatase increased,
Croatian: • promjene krvnih nalaza povezanih s funkcijom bubrega ili jetre (povišena alkalna fosfataza u krvi, sniženi albumin u krvi)
English: The half-life of IV delafloxacin is approximately 10 hours.
Croatian: Poluvijek intravenskog delafloksacina je približno 10 sati.
English: • Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus)
Croatian: • Skupina Streptococcus anginosus (uključujući Streptococcus anginosus, Streptococcus intermedius i Streptococcus constellatus)
English: The radioactivity recovered from faeces is unchanged delafloxacin.
Croatian: Radioaktivnost izlučena u fecesu odnosi se na nepromijenjeni delafloksacin.
English: Chelation active substance: antacids, sucralfate, metal cations, multivitamins There are no data concerning an interaction of intravenous delafloxacin with multivitamins, didanosine, or metal cations.
Croatian: Djelatne tvari koje keliraju: antacidi, sukralfat, metalni kationi, multivitamini Nema podataka o interakciji intravenskog delafloksacina s multivitaminima, didanozinom ili metalnim kationima.
English: Effect of other medicinal products on delafloxacin
Croatian: Djelovanje drugih lijekova na delafloksacin
English: If these reactions occur in patients receiving delafloxacin, delafloxacin should be discontinued immediately and appropriate measures should be instituted.
Croatian: Ako se ove reakcije pojave u bolesnika koji primaju delafloksacin, odmah treba prekinuti primjenu delafloksacina i poduzeti odgovarajuće mjere.
English: Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
Croatian: Bolesnicima se mora savjetovati da se prije nastavka liječenja odmah jave svom liječniku ako se pojave kožne reakcije i/ili reakcije na sluznicama.
English: Fluoroquinolones may also cause CNS reactions of nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and suicidal thoughts or acts.
Croatian: Fluorokinoloni također mogu uzrokovati reakcije središnjeg živčanog sustava kao što su nervoza, agitacija, nesanica, anksioznost, noćne more, paranoja, omaglica, konfuzija, tremori,
English: Corticosteroids should not be used if signs of tendinopathy occur (see section 4.8).
Croatian: Ako se pojave znakovi tendinopatije, ne smiju se primjenjivati kortikosteroidi (vidjeti dio 4.8).
English: Delafloxacin does not induce CYP1A2, CYP2B6, CYP2C9, CYP2C8, CYP2C19 or CYP3A4/5.
Croatian: Delafloksacin ne inducira CYP1A2, CYP2B6, CYP2C9, CYP2C8, CYP2C19 ili CYP3A4/5.
English: Pharmacokinetic parameters are not altered in obese patients (BMI ≥ 30 kg/m2).
Croatian: Farmakokinetički parametri nisu promijenjeni u pretilih bolesnika (ITM ≥ 30 kg/m2).