FrancophonIA/ELRC3.0 huggingface dataset:
English: Elevated liver function tests were generally reversible on discontinuation of therapy and in some instances these tests normalised without interruption of therapy.
Croatian: Povišeni rezultati pretraga jetrene funkcije bili su u pravilu reverzibilni po prekidu terapije, a u nekim su se slučajevima normalizirali i bez prekida terapije.
English: Tell your doctor, pharmacist or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Croatian: Odmah obavijestite liječnika, ljekarnika ili medicinsku sestru ako se pojavi neka od sljedećih ozbiljnih nuspojava - možda će Vam biti potrebno hitno liječenje:
English: Store in a refrigerator at 2°C-8°C.
Croatian: Čuvati u hladnjaku na temperaturi 2°C-8°C.
English: Do not switch between taking Noxafil tablets and Noxafil oral suspension without talking to your doctor or pharmacist because it may result in a lack of efficacy or an increased risk of adverse reactions.
Croatian: Nemojte prijeći s Noxafil tableta na Noxafil oralnu suspenziju ili obrnuto bez razgovora s liječnikom ili ljekarnikom jer to može dovesti do smanjenja djelotvornosti i povećanog rizika za pojavu nuspojava.
English: • Do not crush, chew, break or dissolve the tablet.
Croatian: • Nemojte drobiti, žvakati, lomiti niti otapati tabletu.
English: Schering-Plough Labo N.V., Industriepark 30, Zone A, BE-2220 Heist-op-den-Berg, Belgium
Croatian: Schering-Plough Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgija
English: • pseudoaldosteronism, which results in high blood pressure with a low potassium level (shown in blood test)
Croatian: • pseudoaldosteronizam, koji uzrokuje visoki krvni tlak s niskom razinom kalija u krvi (vidljivo u krvnim pretragama)
English: Therefore, in subsequent studies posaconazole was administered via central venous catheter.
Croatian: Stoga se u kasnijim ispitivanjima posakonazol primjenjivao kroz centralni venski kateter.
English: • inflammation or pain at injection site
Croatian: • upala ili bol na mjestu injekcije.
English: Posaconazole does not have any major circulating metabolites.
Croatian: Posakonazol nema značajnijih cirkulirajućih metabolita.
English: However, in clinical efficacy trials, the safety profile of posaconazole between the young and elderly patients was similar.
Croatian: Međutim, u kliničkim ispitivanjima djelotvornosti sigurnosni profil posakonazola bio je sličan u mlađih i starijih bolesnika.
English: • having problems thinking or talking, having jerking movements, especially in your hands that you cannot control
Croatian: • problemi s razmišljanjem ili govorom, nevoljni trzajni pokreti, osobito ruku, koje ne možete kontrolirati
English: 2, rue Louis Pasteur F-14200 Hérouville St Clair France
Croatian: 2, rue Louis Pasteur F-14200 Hérouville St Clair Francuska
English: • However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule.
Croatian: • Međutim, ako je uskoro vrijeme za sljedeću dozu, preskočite propuštenu dozu i nastavite s uzimanjem prema uobičajenom rasporedu.
English: Noxafil oral suspension and tablets are NOT interchangeable.
Croatian: Noxafil oralna otopina i tablete NISU međusobno zamjenjive.
English: There are limited pharmacokinetic data in patients with severe gastrointestinal dysfunction (such as severe diarrhoea).
Croatian: Ograničeni su farmakokinetički podaci u bolesnika s teškom gastrointestinalnom disfunkcijom (npr. jakim proljevom).
English: See Section 4 for more information.
Croatian: Za više informacija pogledajte dio 4.
English: Cenexi HSC, 2, rue Louis Pasteur; 14200 Hérouville St Clair, France
Croatian: Cenexi HSC, 2, rue Louis Pasteur; 14200 Hérouville St Clair, Francuska
English: Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.
Croatian: Izostanak odgovora na liječenje definira se kao napredovanje infekcije ili izostanak poboljšanja nakon najmanje 7 dana primjene terapijskih doza djelotvornih antimikotika.
English: Clear, colourless to yellow liquid.
Croatian: Bistra, bezbojna do žuta tekućina.
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Unutar organskih sustava, nuspojave su navedene prema učestalosti pojavljivanja definiranoj kao: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The study treated 155 (65 %) subjects with AML or MDS, and 82 (35 %) subjects with HSCT, as the primary diseases at study entry.
Croatian: U ispitivanju je liječeno 155 (65%) ispitanika s AML-om ili MDS-om te 82 (35%) bolesnika s HSCT-om kao osnovnom bolešću pri uključivanju u ispitivanje.
English: This medicinal product is for single use only and any unused solution should be discarded.
Croatian: Lijek je namijenjen samo za jednokratnu uporabu i svu neiskorištenu otopinu treba zbrinuti.
English: • Once prepared, the product should be used immediately.
Croatian: • Nakon pripreme lijek treba odmah primijeniti.
English: An increase in Cmax (26 %) and AUC (29 %) was observed in elderly subjects (24 subjects  65 years of age) relative to younger subjects (24 subjects 18 - 45 years of age).
Croatian: Opažen je porast Cmax (26%) i AUC-a (29%) u starijih ispitanika (24 ispitanika  65 godina) u odnosu na mlađe ispitanike (24 ispitanika u dobi 18-45 godina).
English: Contains also liquid glucose.
Croatian: Sadrži i tekuću glukozu.
English: • efavirenz and fosamprenavir used to treat HIV infection.
Croatian: • efavirenz i fosamprenavir, koji se koriste za liječenje HIV-infekcije.
English: you will need a blood test and you will need to look out for some possible side effects of rifabutin.
Croatian: trebat ćete kontrolirati krvnu sliku i paziti na neke moguće nuspojave rifabutina.
English: Posaconazole tablets
Croatian: Posakonazol tablete
English: New diagnosis of acute myelogenous leukaemia was the most common underlying condition (435/602, [72 %]).
Croatian: Najčešća osnovna bolest bila je novodijagnosticirana akutna mijeloična leukemija (435/602, [72%]).
English: You will be given Noxafil:
Croatian: Noxafil ćete primiti:
English: Noxafil can increase the amount of these medicines in the blood which may lead to a severe decrease in blood flow to your fingers or toes and could cause damage to them.
Croatian: Noxafil može povećati količinu ovih lijekova u krvi, što može dovesti do jakog smanjenja krvotoka u prstima na rukama ili nogama i može izazvati njihova oštećenja.
English: The oral suspension must be shaken well before use.
Croatian: Oralnu suspenziju se prije primjene mora dobro protresti.
English: When Noxafil treatment is stopped by your doctor you should not experience any effects.
Croatian: Kada Vaš liječnik prekine liječenje lijekom Noxafil, ne biste trebali osjetiti nikakve nuspojave.
English: Each dose of Noxafil should be administered during or immediately after a meal, or a nutritional supplement in patients who cannot tolerate food to enhance the oral absorption and to ensure adequate exposure.
Croatian: Svaka doza lijeka Noxafil mora se primijeniti tijekom ili neposredno nakon obroka, odnosno nadomjeska prehrani u bolesnika koji ne podnose hranu, kako bi se poboljšala oralna apsorpcija i osigurala primjerena izloženost lijeku.
English: • have any problem with potassium, magnesium or calcium levels in your blood
Croatian: • ako imate bilo koji poremećaj razine kalija, magnezija ili kalcija u krvi
English: See Table 4 and 5 for results from both studies.
Croatian: Vidjeti Tablice 4 i 5 za rezultate iz oba ispitivanja.
English: Patients with glucose-galactose malabsorption should not take this medicine.
Croatian: Bolesnici koji imaju poremećaj malapsorpcije glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: In Study 1899, a significant decrease in all cause mortality in favour of posaconazole was observed [POS 49/304 (16 %) vs. FLU/ITZ 67/298 (22 %) p= 0.048].
Croatian: Ispitivanju 1899 opaženo je značajno smanjenje smrtnosti zbog bilo kojeg uzroka u korist posakonazola [POS 49/304 (16%) naspram FLU/ITZ 67/298 (22%) p=0,048].
English: renal tubular acidosis, interstitial nephritis
Croatian: renalna tubularna acidoza, intersticijski nefritis
English: Do not take Noxafil if you are taking any of the following:
Croatian: Nemojte uzimati Noxafil ako uzimate neki od sljedećih lijekova:
English: However, if it is almost time for your next dose, take your dose when it is due.
Croatian: Međutim, ako je uskoro vrijeme za sljedeću dozu, uzmite tu sljedeću dozu u predviđeno vrijeme.
English: • blood problems such as unusual blood clotting or prolonged bleeding
Croatian: • krvni poremećaji poput neuobičajenog zgrušavanja krvi ili produljenog krvarenja,
English: • allergic reaction
Croatian: • alergijska reakcija.
English: The majority (377/600, [63 %]) of patients included had Acute Grade 2 or 3 or chronic extensive (195/600, [32.5 %]) GVHD at study start.
Croatian: Većina uključenih bolesnika (377/600, [63%]) je na početku ispitivanja imala akutni GVHD stupnja 2 ili 3 ili kronični opsežni GVHD (195/600, [32,5%]).
English: Note: In clinical trials, multiple peripheral infusions given through the same vein resulted in infusion site reactions (see section 4.8).
Croatian: Napomena: U kliničkim ispitivanjima, višekratne infuzije primijenjene kroz istu perifernu venu dovele su do reakcija na mjestu infuzije (vidjeti dio 4.8).
English: Unbound concentrations were not determined and it cannot be excluded that there is a larger increase in unbound posaconazole exposure than the observed 60 % increase in total AUC.
Croatian: Nisu određene koncentracije nevezanog lijeka te se ne može isključiti da je porast izloženosti nevezanom posakonazolu veći od opaženog porasta ukupnog AUC-a od 60%.
English: • heartburn (a burning sensation in the chest rising up to the throat)
Croatian: • žgaravica (žarenje u prsištu koje se diže do grla)
English: Alternatively, if recommended by your doctor, you may take 400 mg (two 5 mL spoonfuls) twice a day provided that you are able to take both doses during or after food or a nutritional drink.
Croatian: Druga mogućnost, ako tako preporuči liječnik, je uzimati dozu od 400 mg (dvije žličice od 5 ml) dvaput na dan, pod uvjetom da obje doze možete uzeti tijekom ili nakon obroka ili nutritivnog napitka.
English: An increased effect on the QTc interval cannot be ruled out.
Croatian: Ne može se isključiti pojačan učinak na QTc interval.
English: • blurred vision, sensitivity to light
Croatian: • zamagljen vid, osjetljivost na svjetlost
English: • nerve damage (neuropathy)
Croatian: • oštećenje živaca (neuropatija)
English: This exposure was selected based on pharmacokinetic/pharmacodymanic considerations with posaconazole oral suspension.
Croatian: Ova je izloženost odabrana na temelju farmakokinetičkih/farmakodinamičkih razmatranja posakonazol oralne suspenzije.
English: A switch to oral administration is recommended as soon as the patients' condition allows (see section 4.4).
Croatian: Preporučuje se prelazak na peroralnu primjenu čim to bolesnikovo stanje dopusti (vidjeti dio 4.4).
English: Stevens Johnson syndrome, vesicular rash
Croatian: Stevens Johnsonov sindrom, vezikularni osip
English: No dose adjustment is recommended for patients with mild to severe hepatic impairment but caution is advised due to the potential for higher plasma exposure.
Croatian: Ne preporučuje se prilagodba doze za bolesnike s blagim do teškim oštećenjem funkcije jetre, ali se savjetuje oprez zbog moguće veće izloženosti u plazmi.
English: One bottle of 105 mL of oral suspension.
Croatian: Jedna boca sa 105 ml oralne suspenzije.
English: Noxafil tablets are the preferred formulation to optimize plasma concentrations and generally provide higher plasma drug exposures than Noxafil oral suspension.
Croatian: Noxafil tablete formulacija su kojoj se daje prednost za optimiziranje koncentracija u plazmi i općenito osiguravaju veću izloženost lijeku u plazmi od Noxafil oralne suspenzije.
English: • medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir,
Croatian: • lijekovi koji se primjenjuju za liječenje HIV-infekcije, a zovu se inhibitori proteaze (uključujući lopinavir i atazanavir koji se primjenjuju s ritonavirom),
English: One subject (<1 %) had a predicted Cav below 500 ng/mL and 19 % of the subjects had a predicted Cav above 2,500 ng/mL.
Croatian: Jedan ispitanik (<1%) imao je predviđeni Cav manji od 500 ng/ml, a 19% ispitanika imalo je predviđeni Cav veći od 2500 ng/ml.
English: From a microbiological point of view, once admixed, the product should be used immediately.
Croatian: S mikrobiološkog stanovišta, nakon miješanja lijek treba odmah primijeniti.
English: Noxafil concentrate for solution for infusion should not be used in children aged below 18 years because of pre-clinical safety concerns (see section 5.3).
Croatian: Noxafil koncentrat za otopinu za infuziju ne smije se primjenjivati u djece mlađe od 18 godina zbog sigurnosnih pitanja primijećenih u pretkliničkim ispitivanjima (vidjeti dio 5.3).
English: Noxafil can increase the amount of these medicines in the blood which may lead to very serious changes to your heart rhythm.
Croatian: Noxafil može povećati količinu ovih lijekova u krvi, što može dovesti do vrlo ozbiljnih promjena srčanog ritma.
English: Fixed-time period
Croatian: U definiranom vremenskom razdoblju
English: Thromboembolic events have been identified as a potential risk for posaconazole intravenous concentrate for solution for infusion but were not observed in the clinical studies.
Croatian: Troboembolijski događaji prepoznati su kao potencijalni rizik kod intravenske primjene posakonazol koncentrata za otopinu za infuziju, ali nisu bili primijećeni u kliničkim ispitivanjima.
English: Noxafil 100 mg gastro-resistant tablets are packaged in a PVC/ polychlorotrifluoroethylene laminate blister with push-through aluminium lidding.
Croatian: Noxafil 100 mg želučanootporne tablete pakirane su u PVC/poliklorotrifluoroetilen laminat blisteru s aluminijskim pokrovom kroz koji se mogu protisnuti.
English: The clinical response rates from the above study are shown in the Table 4 below.
Croatian: Stope kliničkog odgovora u ovom ispitivanju prikazane su u Tablici 4.
English: Noxafil concentrate for solution for infusion will always be prepared and given to you by a healthcare professional.
Croatian: Noxafil koncentrat za otopinu za infuziju uvijek će pripremiti i primijeniti zdravstveni radnik.
English: • water retention (oedema)
Croatian: • zadržavanje vode (edemi)
English: The clinical significance of this finding is unknown; therefore, the use of posaconazole concentrate for solution for infusion to patients under 18 years of age is not recommended (see section 4.2).
Croatian: Klinički značaj ovih nalaza nije poznat; stoga se ne preporučuje primjena posakonazol koncentrata za otopinu za infuziju bolesnicima mlađima od 18 godina (vidjeti dio 4.2).
English: You may feel dizzy, sleepy, or have blurred vision while taking Noxafil, which may affect your ability to drive or use tools or machines.
Croatian: Dok uzimate Noxafil, možete osjetiti omaglicu, pospanost ili imati zamućen vid, što može utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: • have a weakness of the heart muscle or heart failure
Croatian: • ako imate slabost srčanog mišića ili zatajenje srca;
English: If not used immediately, the solution can be stored up to 24 hours at 2°C-8°C (in a refrigerator).
Croatian: Ako se ne primijeni odmah, otopina se može čuvati najdulje 24 sata na temperaturi 2C-8C (u hladnjaku).
English: In the fasting state, AUC increased less than in proportion to dose above 200 mg.
Croatian: Pri uzimanju natašte, AUC se pri dozama iznad 200 mg povećavao manje nego proporcionalno dozi.
English: Rare: the following may affect up to 1 in 1,000 people
Croatian: Rijetko: mogu se javiti u do 1 na 1000 osoba
English: 105 mL of oral suspension in a bottle (glass amber type IV) closed with a plastic child-resistant cap (polypropylene) and a measuring spoon (polystyrene) with 2 graduations: 2.5 mL and 5 mL.
Croatian: 105 ml oralne suspenzije u boci (smeđe staklo tipa IV) zatvorenoj plastičnim (polipropilen) sigurnosnim zatvaračem za djecu i mjerna žličica (polistiren) s dvije oznake: 2,5 ml i 5 ml.
English: The table below shows the recommended dose and length of treatment which depend on the type of infection that you have and may be individually adapted for you by your doctor.
Croatian: Tablica ispod prikazuje preporučene doze i trajanje liječenja, koje ovise o vrsti infekcije koju imate i Vaš ih liječnik može individualno prilagoditi prema Vašim potrebama.
English: Study 5615 was conducted in a similar patient population to that previously studied in the pivotal posaconazole oral suspension clinical program.
Croatian: Ispitivanje 5615 provedeno je u populaciji bolesnika koja je bila slična onoj prethodno ispitanoj u glavnom kliničkom programu ispitivanja posakonazol oralne suspenzije.
English: Posaconazole is slowly eliminated with a mean half-life (t½) of 35 hours (range 20 to 66 hours).
Croatian: Posakonazol se sporo eliminira, uz prosječno poluvrijeme (t½) od 35 sati (raspon: 20 do 66 sati).
English: • Infections in the mouth or throat area (known as “thrush”) caused by fungi called Candida, which were not previously treated.
Croatian: • infekcija u području usta ili grla (tzv. „mliječac“) prouzročenih gljivicom Candida, koje nisu prethodno liječene.
English: Patients, in particular those receiving posaconazole after HSCT, who have a low body weight (< 60 kg) are more likely to experience higher plasma concentrations of posaconazole and should be closely monitored for adverse events.
Croatian: Bolesnici, osobito oni koji primaju posakonazol nakon HSCT-a, a koji imaju nisku tjelesnu težinu (<60 kg) imaju veću vjerojatnost za pojavu viših koncentracija posakonazola u plazmi te ih je stoga potrebno pozorno nadzirati zbog pojave nuspojava.
English: No further increases in exposure were observed when doses above 800 mg daily were administered to patients and healthy volunteers.
Croatian: Nije opažen daljnji porast izloženosti lijeku kad su bolesnicima i zdravim dobrovoljcima primijenjene doze veće od 800 mg na dan.
English: The following medicines may decrease the effectiveness of Noxafil by decreasing the amount of Noxafil in the blood:
Croatian: Sljedeći lijekovi mogu smanjiti učinkovitost lijeka Noxafil tako što smanjuju njegovu količinu u krvi:
English: Posaconazole oral suspension
Croatian: Posakonazol oralna suspenzija
English: 24 gastro-resistant tablets 96 gastro-resistant tablets
Croatian: 24 želučanootporne tablete 96 želučanootpornih tableta
English: If you forget to take Noxafil
Croatian: Ako ste zaboravili uzeti Noxafil
English: In twelve-month neurotoxicity studies in dogs and monkeys, no functional effects were observed on the central or peripheral nervous systems at systemic exposures greater than those achieved therapeutically.
Croatian: U dvanaestomjesečnim ispitivanjima neurotoksičnosti na psima i majmunima nisu opaženi funkcionalni učinci na središnji ili periferni živčani sustav pri sustavnoj izloženosti većoj od one koja se postiže tijekom liječenja.
English: • diltiazem, verapamil, nifedipine, nisoldipine or other “calcium channel blockers” (used to treat high blood pressure)
Croatian: • diltiazem, verapamil, nifedipin, nizoldipin ili drugi blokatori kalcijevih kanala (primjenjuju se za liječenje povišenog krvnog tlaka),
English: In Study 316, overall mortality was similar (POS, 25 %; FLU, 28 %); however, the proportion of IFIrelated deaths was significantly lower in the POS group (4/301) compared with the FLU group (12/299; P= 0.0413).
Croatian: U ispitivanju 316 utvrđen je sličan ukupni mortalitet (POS, 25%; FLU, 28%); međutim, udio smrti povezanih s IGI bio je značajno niži u skupini koja je uzimala POS (4/301) nego u skupini koja je primala FLU (12/299; p=0,0413).
English: It is recommended to exercise caution due to the potential for higher plasma exposure.
Croatian: Preporučuje se oprez zbog moguće veće izloženosti lijeku u plazmi.
English: • having a blind or dark spot in your field of vision
Croatian: • slijepa ili tamna mrlja u vidnom polju
English: What Noxafil contains
Croatian: Što Noxafil sadrži
English: • patients having “high-dose immunosuppressive therapy” after “hematopoietic stem cell transplant” (HSCT).
Croatian: • bolesnici koji primaju visoke doze imunosupresiva nakon transplantacije hematopoetskih matičnih stanica (HSCT).
English: There were no neurologic, behavioural or developmental abnormalities in the dogs with this finding, and a similar brain finding was not seen with oral posaconazole administration to juvenile dogs (4 days to 9 months of age).
Croatian: U pasa s tim nalazom nisu zabilježene neurološke ili razvojne anomalije kao ni poremećaji ponašanja, a slični nalazi u mozgu nisu primijećeni kod peroralne primjene posakonazola juvenilnim psima (u dobi od 4 dana do 9 mjeseci).
English: • Aseptically transfer 16.7 mL of posaconazole to an intravenous bag (or bottle) containing a compatible admixture diluent (see below for list of diluents) using the volume ranging from 150 mL to 283 mL depending on the final concentration to be achieved (not less than 1 mg/mL and not greater than 2 mg/mL).
Croatian: • U aseptičkim uvjetima prenesite 16,7 ml posakonazola u vrećicu (ili bocu) za intravensku infuziju koja sadrži otapalo kompatibilnog sastava (vidjeti niže popis otapala) u volumenu od 150 ml do 283 ml, ovisno o konačnoj koncentraciji koja se želi postići (ne niža od 1 mg/ml i ne viša od 2 mg/ml).
English: • If a central venous catheter is not available, a single infusion may be administered through a peripheral venous catheter with a volume to achieve a dilution of approximately 2 mg/mL.
Croatian: • Ako nije dostupan centralni venski kateter, jednokratna infuzija može se primijeniti kroz periferni venski kateter koristeći volumen koji je potreban kako bi se postigla otopina od približno 2 mg/ml.
English: Caution should be used when prescribing Noxafil to patients with hypersensitivity to other azoles.
Croatian: Potreban je oprez kad se Noxafil propisuje bolesnicima preosjetljivima na druge azole.
English: • menstrual problems (abnormal vaginal bleeding)
Croatian: • menstrualne tegobe (neuobičajeno vaginalno krvarenje)
English: The safety of posaconazole oral suspension has been assessed in > 2,400 patients and healthy volunteers enrolled in clinical trials and from post-marketing experience.
Croatian: Sigurnost primjene posakonazol oralne suspenzije ocijenjena je u >2400 bolesnika i zdravih dobrovoljaca uključenih u klinička ispitivanja i na temelju podataka prikupljenih nakon stavljanja lijeka u promet.
English: If concomitant administration is required, close monitoring for breakthrough fungal infections is recommended.
Croatian: Ako je istodobna primjena neophodna, preporučuje se pozorno nadziranje zbog mogućih probojnih gljivičnih infekcija.
English: Most of the cases of aspergillosis were considered to be refractory to prior therapy in both the posaconazole group (88 %) and in the external control group (79 %).
Croatian: Većina slučajeva aspergiloze smatrala se otpornom na prethodnu terapiju kako u skupini koja je primala posakonazol (88%), tako i u vanjskoj kontrolnoj skupini (79%).
English: Tablet coat polyvinyl alcohol macrogol 3350 titanium dioxide (E171) talc iron oxide yellow (E172)
Croatian: Ovojnica tablete poli(vinilni alkohol) makrogol 3350 titanijev dioksid (E171) talk željezov oksid, žuti (E172)
English: The safety of posaconazole concentrate for solution for infusion has been assessed in 268 patients in clinical trials.
Croatian: Sigurnost posakonazol koncentrata za otopinu za infuziju ocijenjena je u 268 bolesnika u kliničkim ispitivanjima.