FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatitis has been reported with azole antifungal agents including CRESEMBA.
Croatian: Hepatitis je prijavljen uz azolne antifungalne lijekove uključujući lijek CRESEMBA.
English: Mannitol Sulfuric acid (for pH-adjustment)
Croatian: Manitol Sulfatna kiselina (za podešavanje pH vrijednosti)
English: Potential of medicinal products to affect the pharmacokinetics of isavuconazole
Croatian: Mogući utjecaj lijekova na farmakokinetička svojstva izavukonazola
English: What Cresemba contains - The active substance is isavuconazole.
Croatian: Što Cresemba sadrži - Djelatna tvar je izavukonazol.
English: CRESEMBA can be taken with or without food.
Croatian: CRESEMBA se može uzimati s hranom ili bez hrane.
English: Fungal strains with reduced in vitro susceptibility to isavuconazole have been reported, and cross-resistance with voriconazole and other triazole antifungal agents cannot be excluded.
Croatian: Zabilježeni su sojevi gljivica sa smanjenom in vitro osjetljivošću na izavukonazol pa se križna rezistencija na vorikonazol i druge triazolne antimikotike ne može isključiti.
English: Table 4Pharmacokinetic comparison for oral and intravenous dose (Mean) ISA 400 mg oral
Croatian: Tablica 4 Farmakokinetička usporedba oralnog i intravenskog doziranja (srednja vrijednost) ISA 400 mg oralno
English: In a double-blind, randomized, active-controlled clinical study of 516 patients with invasive fungal disease caused by Aspergillus species or other filamentous fungi, elevated liver transaminases (alanine aminotransferase or aspartate aminotransferase) > 3 × Upper Limit of Normal (ULN) were reported at the end of study treatment in 4.4% of patients who received CRESEMBA.
Croatian: U dvostruko-slijepom, randomiziranom, aktivnim lijekom kontroliranom kliničkom ispitivanju s 516 bolesnika s invazivnom gljivičnom bolesti uzrokovanom vrstama Aspergillus ili drugim filamentoznim gljivicama, na kraju ispitivanog liječenja zabilježene su povišene jetrene transaminaze (alanin aminotransferaza ili aspartat aminotransferaza) > 3 × gornje granice normale (GGN) kod 4,4 % bolesnika koji su primali lijek CRESEMBA.
English: NNRTI concentrations may decrease (CYP2B6 induction by isavuconazole) or increase.
Croatian: Koncentracije NNRTI se mogu smanjiti (indukcija CYP2B6 izavukonazolom) ili povećati.
English: No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh Classes A and B) (see sections 4.4 and 5.2).
Croatian: Dozu nije potrebno prilagođavati u bolesnika s blagim ili umjerenim oštećenjem jetre (Child-Pugh stadiji A i B) (vidjeti dijelove 4.4. i 5.2).
English: Mycophenolate mofetil (MMF) (UGT substrate)
Croatian: Mofetilmikofenolat (MMF) (supstrat za UGT)
English: Following oral administration of CRESEMBA in healthy subjects, the active moiety isavuconazole is absorbed and reaches maximum plasma concentrations (Cmax) approximately 2-3 hours after single and multiple dosing (see Table 3).
Croatian: Nakon peroralne primjene lijeka CRESEMBA kod zdravih ispitanika, aktivan oblik izavukonazol se apsorbira i postiže maksimalnu koncentraciju u plazmi (Cmax) oko 2-3 sata nakon primjene jedne ili više doza (vidjeti Tablicu 3).
English: Caution is warranted when prescribing CRESEMBA to patients taking other medicinal products known to decrease the QT interval, such as rufinamide.
Croatian: Potreban je oprez kod propisivanja lijeka CRESEMBA bolesnicima koji uzimaju druge lijekove za koje se zna da skraćuju QT interval, poput rufinamida.
English: No clinically relevant changes were observed in the total Cmax and AUC of isavuconazole in subjects with mild, moderate or severe renal impairment compared to subjects with normal renal function.
Croatian: Nisu zabilježene klinički značajne promjene ukupnog Cmax i AUC izavukonazola kod ispitanika s blagim, umjerenim ili teškim oštećenjem bubrega u usporedbi s ispitanicima čija je funkcija bubrega normalna.
English: Studies in animals did not show impairment of fertility in male or female rats (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala smanjenje plodnosti kod mužjaka i ženki štakora (vidjeti dio 5.3).
English: The blister card also contains desiccant.
Croatian: Blister sadrži i sredstvo za sušenje.
English: Deutschland Pfizer Pharma PFE GmbH Tel: +49 (0)800 8535555
Croatian: Pfizer Pharma PFE GmbH Tel: +49 (0)800 8535555
English: For other strong CYP3A4 inhibitors, such as clarithromycin, indinavir and saquinavir, a less pronounced effect can be expected, based on their relative potency.
Croatian: Kod drugih snažnih inhibitora CYP3A4, poput klaritromicina, indinavira i sakvinavira, može se očekivati manje izražen učinak, na temelju njihove relativne potentnosti.
English: Generally, concentrations of isavuconazole required to inhibit Mucorales are higher than those required to inhibit the majority of Aspergillus species.
Croatian: Općenito, koncentracije izavukonazola potrebne za inhibiciju gljivica Mucorales više su od onih koje su potrebne za inhibiciju većine vrsta Aspergillus.
English: During intravenous administration of isavuconazole, infusion-related reactions including hypotension, dyspnoea, dizziness, paraesthesia, nausea, and headache were reported (see section 4.8).
Croatian: Tijekom intravenske primjene izavukonazola, prijavljene su reakcije povezane s infuzijom koje uključuju hipotenziju, dispneju, omaglicu, paraestezije, mučninu i glavobolju (vidjeti dio 4.8).
English: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk, Co. Louth
Croatian: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk, Co.
English: Do not stop taking Cresemba unless you doctor has told you to do so.
Croatian: Nemojte prekidati uzimanje lijeka Cresemba, osim ako Vam to nije rekao Vaš liječnik.
English: Natural products Caffeine (CYP1A2 substrate)
Croatian: Prirodni proizvodi Kofein (supstrat za CYP1A2)
English: Isavuconazole is a mild inhibitor of the organic cation transporter 2 (OCT2).
Croatian: Izavukonazol je slab inhibitor prijenosnika organskih kationa-2 (OCT2).
English: Isavuconazole was negative in a bacterial reverse mutation assay, was weakly clastogenic at cytotoxic concentrations in the L5178Y tk+/- mouse lymphoma chromosome aberration assay, and showed no biologically relevant or statistically significant increase in the frequency of micronuclei in an in vivo rat micronucleus test.
Croatian: Izavukonazol je bio negativan kod testiranja povratnih mutacija na bakteriji, također je bio blago klastogen pri citotoksičnim koncentracijama kod testiranja aberacije kromosoma L5178Y tk+/- kod limfoma u miševa i nije ukazivao ni na kakva biološki ili statistički značajna povećanja učestalosti mikro-jezgri u in vivo mikronukleus testu kod štakora.
English: Midazolam: careful monitoring of clinical signs and symptoms recommended, and dose reduction if required.
Croatian: Midazolam: preporučuje se pažljivo praćenje kliničkih znakova i simptoma te po potrebi smanjenje doze.
English: The adjusted treatment difference (voriconazole−isavuconazole) was 4.0% (95% confidence interval: −7.9; 15.9).
Croatian: Prilagođena terapijska razlika (vorikonazol−izavukonazol) bila je 4,0% (95% interval pouzdanosti: −7,9; 15,9).
English: Isavuconazole is the active moiety formed after oral or intravenous administration of isavuconazonium sulfate (see section 5.2).
Croatian: Izavukonazol je aktivni oblik koji nastaje nakon peroralne ili intravenske primjene izavukonazonijevog sulfata (vidjeti dio 5.2).
English: The most common treatment-related adverse reactions were elevated liver chemistry tests (7.9%), nausea (7.4%), vomiting (5.5%), dyspnoea (3.2%), abdominal pain (2.7%), diarrhoea (2.7%), injection site reaction (2.2%), headache (2.0%), hypokalaemia (1.7%) and rash (1.7%).
Croatian: Najčešće nuspojave povezane s liječenjem bile su povišene vrijednosti laboratorijskih nalaza jetre (7,9%), mučnina (7,4%), povraćanje (5,5%), dispneja (3,2%), bolovi u abdomenu (2,7%), proljev (2,7%), reakcija na mjestu davanja injekcije (2,2%), glavobolja (2,0%), hipokalemija (1,7%) i osip
English: Ciclosporin, sirolimus, tacrolimus: monitoring of plasma levels and appropriate dose adjustment if required.
Croatian: Ciklosporin, sirolimus, takrolimus: praćenje razine u plazmi i odgovarajuća prilagodba doze ako je potrebno.
English: These data indicate that concentrations of isavuconazole required for inhibition in vitro are very variable between genera/species within the order of Mucorales, and generally higher than concentrations required to inhibit Aspergillus species.
Croatian: Ovi podaci upućuju da su koncentracije izavukonazola potrebne za in vitro inhibiciju vrlo različite među rodovima/vrstama unutar reda Mucorales i općenito više od koncentracija koje su potrebne za inhibiciju vrsta Aspergillus.
English: Saquinavir concentrations may decrease (as observed with lopinavir/ritonavir) or increase (CYP3A4 inhibition).
Croatian: Koncentracije sakvinavira mogu se smanjiti (što je uočeno s lopinavirom/ritonavirom) ili povećati (inhibicija CYP3A4).
English: Marked elevations of liver transaminases > 10 × ULN developed in 1.2% of patients on isavuconazole.
Croatian: Izrazito povećanje jetrenih transaminaza > 10 × GGN zabilježeno je kod 1,2 % bolesnika koji su primali izavukonazol.
English: If a patient develops a severe cutaneous adverse reaction, CRESEMBA should be discontinued.
Croatian: Ako se u bolesnika pojavi teška nuspojava na koži, terapiju lijekom CRESEMBA treba obustaviti.
English: For other strong CYP3A4/5 inhibitors, a less pronounced effect can be expected.
Croatian: Kod ostalih snažnih inhibitora CYP3A4/5 može se očekivati manje izražen učinak.
English: # See section Description of selected adverse reactions below
Croatian: # vidjeti u nastavku dio Opis odabranih nuspojava
English: Based on results with atorvastatin, no statin dose adjustment required.
Croatian: Na temelju rezultata o atorvastatinu, nije potrebna prilagodba doze statina.
English: Isavuconazole is not readily dialysable (see section 4.2).
Croatian: Izavukonazol se ne odstranjuje lako dijalizom (vidjeti dio 4.2).
English: The recommended dose is one vial once a day.
Croatian: Preporučena doza je jedna bočica jedanput na dan.
English: For patients with probable or proven mucormycosis as defined by the independent Data Review Committee (DRC), all-cause mortality at Day 84 was 43.2% (16/37) for the overall patient population, 42.9% (9/21) for mucormycosis patients receiving isavuconazole as primary treatment, and 43.8% (7/16) for mucormycosis patients receiving isavuconazole who were refractory to, or intolerant of, prior antifungal therapy (mainly amphotericin B-based treatments).
Croatian: Prema ocjeni neovisnog Odbora za pregled podataka (DRC), kod bolesnika s vjerojatnom ili dokazanom mukormikozom smrtnost bez obzira na uzrok na 84. dan bila je 43,2% (16/37) za ukupnu populaciju bolesnika, 42,9% (9/21) za bolesnike s mukormikozom koji su primali izavukonazol kao primarnu terapiju i 43,8% (7/16) za bolesnike s mukormikozom koji su primali izavukonazol, a koji su bili rezistentni na ili nisu podnosili prethodnu terapiju antimikoticima (uglavnom liječenje na bazi amfotericina B).
English: Caution should be used in prescribing isavuconazole to patients with hypersensitivity to other azole antifungal agents.
Croatian: Potreban je oprez kod propisivanja izavukonazola bolesnicima koji su preosjetljivi na druge antimikotike iz skupine azola.
English: Administration of isavuconazonium sulfate to rats at a dose of 90 mg/kg/day (2.3-fold the human maintenance dose [200 mg] based on mg/m2/day) during pregnancy through the weaning period showed an increased perinatal mortality of the pups.
Croatian: Primjena izavukonazonijevog sulfata kod štakora u dozi od 90 mg/kg/dan (2,3 puta više od doze održavanja za čovjeka [200 mg] na temelju mg/m2/dan) tijekom graviditeta i razdoblja odvikavanja od sisanja pokazala je povećanu perinatalnu smrtnost mladunčadi.
English: Excipients: mannitol (E421) and sulfuric acid
Croatian: Pomoćne tvari: manitol (E421) i sulfatna kiselina
English: Dose adjustment of medicinal products that are P-gp substrates, especially medicinal products with a narrow therapeutic index such as digoxin, colchicine and dabigatran etexilate, may be needed when concomitantly administered with CRESEMBA (see section 4.5).
Croatian: Prilagodba doze lijekova koji su supstrati za P-gp, a naročito lijekova s uskim terapijskim indeksom poput digoksina, kolhicina i dabigatraneteksilata, može biti potrebna kada se ti lijekovi primjenjuju istodobno s lijekom CRESEMBA (vidjeti dio 4.5).
English: Management of overdose
Croatian: Liječenje predoziranja
English: Following administration, isavuconazonium sulfate is rapidly hydrolysed by plasma esterases to the active moiety isavuconazole; plasma concentrations of the prodrug are very low, and detectable only for a short time after intravenous dosing.
Croatian: Nakon primjene, izavukonazonijev sulfat brzo se hidrolizira pomoću plazmatskih esteraza do aktivnog oblika, izavukonazola; koncentracije predlijeka u plazmi vrlo su niske i mjerljive su samo kratko vrijeme nakon intravenske primjene doze.
English: C] isavuconazonium sulfate in humans, in addition to the active moiety (isavuconazole) and the inactive cleavage product, a number of minor metabolites were identified.
Croatian: C] izavukonazonijevog sulfata u ljudi, osim aktivnog oblika (izavukonazola) i inaktivnog produkta razgradnje, utvrđeni su brojni sekundarni metaboliti.
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog iza “Rok valjanosti”/”EXP”.
English: The concomitant administration of CRESEMBA and carbamazepine, phenytoin and long-acting barbiturates such as phenobarbital is contraindicated.
Croatian: Istodobna primjena lijeka CRESEMBA i karbamezapina, fenitoina i barbiturata s dugotrajnim djelovanjem poput fenobarbitala je kontraindicirana.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of isavuconazole/metabolites in milk (see section 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci za životinje su pokazali da se izavukonazol/metaboliti izlučuju u majčino mlijeko (vidjeti dio 5.3).
English: The adjusted treatment difference (isavuconazole−voriconazole) was −2.7% (95 % confidence interval: −12.9; 7.5).
Croatian: Prilagođena terapijska razlika (izavukonazol-vorikonazol) bila je -2,7% (95% interval pouzdanosti: −12,9; 7,5).
English: - The other ingredients (excipients) are mannitol (E421) and sulfuric acid.
Croatian: - Drugi sastojci (pomoćne tvari) su manitol (E421) i sulfatna kiselina.
English: Ritonavir (at doses >200 mg every 12 hours) (strong CYP3A4/5 inducer)
Croatian: Ritonavir (kod doza >200 mg svakih 12 sati) (snažan induktor enzima CYP3A4/5)
English: In a QT study in healthy human subjects, isavuconazole shortened the QTc interval in a concentration-related manner.
Croatian: U ispitivanju QT intervala sa zdravim ispitanicima, izavukonazol je skratio QTc interval ovisno o koncentraciji.
English: Isavuconazole demonstrates a fungicidal effect by blocking the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of cytochrome P-450-dependent enzyme lanosterol 14-alpha-demethylase, responsible for the conversion of lanosterol to ergosterol.
Croatian: Izavukonazol pokazuje fungicidno djelovanje blokiranjem sinteze ergosterola, glavnog sastojka stanične membrane gljivica, inhibicijom citokrom P-450 ovisnog enzima lanosterol 14-alfa demetilaze, zaduženog za konverziju lanosterola u ergosterol.
English: Therefore, caution is advised when CYP2B6 substrates, especially medicinal products with a narrow therapeutic index such as cyclophosphamide, are co-administered with CRESEMBA.
Croatian: Stoga se preporučuje oprez kod istodobne primjene supstrata CYP2B6, naročito lijekova s uskim terapijskim indeksom poput ciklofosfamida, s lijekom CRESEMBA.
English: Systemic exposure to medicinal products metabolised by CYP2B6 may be decreased when co-administered with CRESEMBA.
Croatian: Sistemska izloženost lijekovima koji se metaboliziraju putem CYP2B6 može se smanjiti kada se primjenjuju istodobno s lijekom CRESEMBA.
English: Metformin (OCT1, OCT2 and MATE1 substrate)
Croatian: Metformin (supstrat za OCT1, OCT2 i MATE1)
English: It must be further diluted prior to administration.
Croatian: Prije primjene mora se dodatno razrijediti.
English: Cresemba 200 mg powder for concentrate for solution for infusion must be reconstituted and diluted prior to infusion.
Croatian: Cresemba 200 mg prašak za koncentrat za otopinu za infuziju mora se rekonstituirati i razrijediti prije primjene infuzije.
English: Vinca alkaloid concentrations may increase.
Croatian: Koncentracije vinka alkaloida se mogu povećati.
English: The infusion solution contains approximately 1.5 mg/mL isavuconazonium sulfate (corresponding to approximately 0.8 mg isavuconazole per mL).
Croatian: Infuzijska otopina sadrži približno 1,5 mg/mL izavukonazonijevog sulfata (što odgovara približno 0,8 mg izavukonazola po mL).
English: ISA 400 mg i.v.
Croatian: ISA 400 mg intravenski
English: You will take this dose until your doctor tells you otherwise.
Croatian: Ovu dozu ćete uzimati tako dugo dok Vam liječnik ne kaže drugačije.
English: Do not swallow or use the desiccant.
Croatian: Nemojte progutati niti koristiti sredstvo za sušenje.
English: Increasing the dose to 600 mg resulted in an LSM difference from placebo of 24.6 ms at 2 hours post dose [90% CI: 28.7, 20.4 ms].
Croatian: Povećanje doze na 600 mg rezultiralo je LSMrazlikom u odnosu na placebo od 24,6 ms 2 sata nakon primjene doze [90% CI: 28,7; 20,4 ms].
English: Isavuconazole did not affect the fertility of male or female rats treated with oral doses up to 90 mg/kg/day (2.3-fold the clinical maintenance dose based on mg/m2/day comparisons).
Croatian: Izavukonazol nije utjecao na plodnost mužjaka niti ženki štakora liječenih oralnim dozama do najviše 90 mg/kg/dan (2,3 puta više od kliničke doze održavanja, na temelju usporedbi mg/m2/dan).
English: What Cresemba looks like and contents of the pack Cresemba 100 mg hard capsules are capsules with a reddish-brown body marked with “100” in black ink and a white cap marked with “C” in black ink.
Croatian: Cresemba 100 mg tvrde kapsule su kapsule sa crvenkasto-smeđim tijelom, s oznakom „100“ u crnoj tinti i bijelom kapicom s oznakom „C“ u crnoj tinti.
English: The population pharmacokinetic evaluation of isavuconazole in healthy subjects and patients with mild or moderate hepatic dysfunction demonstrated that the mild and moderate hepatic impairment populations had 40% and 48% lower isavuconazole clearance (CL) values, respectively, than the healthy population.
Croatian: Procjena populacijske farmakokinetike izavukonazola u zdravih ispitanika i bolesnika s blagim i umjerenim oštećenjem jetre pokazala je da populacija s blagim oštećenjem jetre ima 40% a ona s umjerenim 48% niže vrijednosti klirensa izavukonazola u usporedbi sa zdravim osobama.
English: Caution is advised when CRESEMBA is given concomitantly with substrates of BCRP.
Croatian: Preporučuje se oprez kod istodobne primjene lijeka CRESEMBA sa supstratima za BCRP.
English: Cresemba is used in adults to treat the following fungal infections: - invasive aspergillosis, caused by a fungus in the ‘Aspergillus' group; - mucormycosis, caused by a fungus beloning to the ‘Mucorales' group in patients for whom a treatment with amphotericin B is not appropriate.
Croatian: Cresemba se koristi u odraslih za liječenje sljedećih gljivičnih infekcija: - invazivne aspergiloze uzrokovane gljivicama skupine „Aspergillus“; - mukormikoze uzrokovane gljivicama koje pripadaju skupini „Mucorales“ u bolesnika u kojih se ne može primjenjivati liječenje amfotericinom B.
English: Starting dose for the first two days (48 hours) The recommended dose is two capsules three times a day (every 8 hours).
Croatian: Početna doza tijekom prva dva dana (48 sati) Preporučena doza su dvije kapsule tri puta na dan (svakih 8 sati).
English: Ethinyl oestradiol and norethindrone: no dose adjustment required.
Croatian: Etinilestradiol i noretindron: nije potrebna prilagodba doze.
English: No dose adjustment is necessary in patients with renal impairment, including patients with end-stage renal disease (see section 5.2).
Croatian: Dozu nije potrebno prilagođavati u bolesnika s oštećenjem bubrega; uključujući i bolesnike sa završnim stadijem bubrežne bolesti (vidjeti dio 5.2).
English: Patients with familial short QT syndrome (see section 4.4).
Croatian: Bolesnici s nasljednim sindromom kratkog QT intervala (vidjeti dio 4.4).
English: Medicinal products renally excreted via transport proteins
Croatian: Lijekovi koji se izlučuju bubrezima putem transportnih proteina
English: Co-administration should be avoided unless the potential benefit is considered to outweigh the risk.
Croatian: Istodobnu primjenu treba izbjegavati osim ako se smatra da potencijalna korist nadmašuje rizik.
English: CRESEMBA is contraindicated in patients with familial short QT syndrome (see section 4.3).
Croatian: CRESEMBA je kontraindicirana u bolesnika s nasljednim sindromom kratkog QT intervala (vidjeti dio 4.3).
English: What Cresemba is used for
Croatian: Za što se Cresemba koristi
English: (OCT2 inhibition)
Croatian: (Inhibicija OCT2)
English: In vitro / in vivo studies indicate that CYP3A4, CYP3A5, and subsequently uridine diphosphateglucuronosyltransferases (UGT), are involved in the metabolism of isavuconazole.
Croatian: Ispitivanja in vitro / in vivo ukazuju da su CYP3A4, CYP3A5 i naknadno uridindifosfatglukuronoziltransferaze (UGT) uključeni u metabolizam izavukonazola.
English: Repaglinide (CYP2C8 and OATP1B1 substrate)
Croatian: Repaglinid (supstrat za CYP2C8 i OATP1B1)
English: Concomitant use of CRESEMBA with CYP3A4 substrates such as the immunosuppressants tacrolimus, sirolimus or ciclosporin may increase the systemic exposure to these medicinal products.
Croatian: Istodobna primjena lijeka CRESEMBA sa supstratima CYP3A4 poput imunosupresiva takrolimusa, sirolimusa ili ciklosporina može povećati sistemsku izloženost ovim lijekovima.
English: Cresemba may make you feel confused, tired or sleepy.
Croatian: Cresemba može izazvati smetenost, umor ili pospanost.
English: In an open-label non-controlled study, 37 patients with proven or probable mucormycosis received isavuconazole at the same dose regimen as that used to treat invasive aspergillosis.
Croatian: U otvorenom nekontroliranom ispitivanju, 37 bolesnika s dokazanom ili vjerojatnom mukormikozom primalo je izavukonazol prema istom režimu doziranja koji se primjenjivao za liječenje invazivne aspergiloze.
English: Short-acting opiates (alfentanyl, fentanyl): careful monitoring for any occurrence of drug toxicity, and dose reduction if required.
Croatian: Opijati s kratkotrajnim djelovanjem (alfentanil, fentanil): potrebno je pažljivo praćenje radi mogućeg razvoja toksičnosti lijeka i po potrebi smanjenje doze.
English: After a single 100 mg dose of isavuconazole was administered to 32 patients with mild (Child-Pugh Class A) hepatic insufficiency and 32 patients with moderate (Child-Pugh Class B) hepatic insufficiency (16 intravenous and 16 oral patients per Child-Pugh class), the least square mean systemic exposure (AUC) increased 64% in the Child-Pugh Class A group, and 84% in the Child-Pugh Class B group, relative to 32 age- and weight-matched healthy subjects with normal hepatic function.
Croatian: Nakon jednokratne doze od 100 mg izavukonazola primijenjene kod 32 bolesnika s blagim oštećenjem jetre (Child-Pugh stadij A) i 32 bolesnika s umjerenim oštećenjem jetre (Child-Pugh stadij B) (16 intravenski i 16 oralno u svakom Child-Pugh stadiju), srednja vrijednost sistemske izloženosti (AUC) procijenjena metodom najmanjih kvadrata povećala se 64% u skupini Child-Pugh stadij A i 84% u skupini Child-Pugh stadij B u odnosu na 32 zdrave osobe s normalnom funkcijom jetre, usklađene po dobi i tjelesnoj težini.
English: Effects on drug concentrations / Geometric Mean Change (%) in AUC, Cmax (Mode of action)
Croatian: Učinci na koncentracije lijeka / promjena geometrijske srednje vrijednosti (%) AUC, Cmax.