FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients in both study arms were permitted to switch to oral fluconazole after at least 10 days of intravenous therapy, provided that they were able to tolerate oral medicinal products and were afebrile for at least 24 hours, and that the most recent blood cultures were negative for Candida species.
Slovenian: Bolniki v obeh krakih preskušanja so lahko po vsaj 10 dneh intravenskega zdravljenja prešli na peroralni flukonazol pod pogoji, da so prenašali peroralno zdravilo, da so bili vsaj 24 ur afebrilni in da so bile najnovejše hemokulture negativne za vrste Candida.
English: All-cause mortality up to the 6 Week FollowUp visit for anidulafungin (MITT population) was 4/11 (36.4%) and 2/3 (66.7%) for caspofungin.
Slovenian: Umrljivost zaradi vseh razlogov do kontrolnega obiska v 6. tednu je bila 4/11 (36,4 %) za anidulafungin (populacija MITT) in 2/3 (66,7 %) za kaspofungin.
English: Although weight was identified as a source of variability in clearance in the population pharmacokinetic analysis, weight has little clinical relevance on the pharmacokinetics of anidulafungin.
Slovenian: Čeprav se je telesna masa izkazala kot vir variabilnosti očistka v analizi populacijske farmakokinetike, je njen klinični pomen za farmakokinetiko anidulafungina majhen.
English: Rate of Successful Global Response a and All-Cause Mortality in Patients with Deep Tissue Candidiasis - Pooled Analysis MITT Population n/N (%)
Slovenian: Delež uspešnega globalnega odziva a in umrljivost zaradi vseh vzrokov pri bolnikih s kandidozo globokega tkiva - analiza združenih podatkov Populacija MITT n/N (%)
English: Anidulafungin is not dialysable and may be administered without regard to the timing of hemodialysis.
Slovenian: Anidulafungin se ne dializira in ga je mogoče aplicirati ne glede na čas hemodialize.
English: Specifically, for C. parapsilosis, the MICs of anidulafungin are higher than are those of other Candida species.
Slovenian: Predvsem pri C. parapsilosis so vrednosti MIK za anidulafungin večje kot vrednosti za druge vrste Candida.
English: The successful global response rate at the end of intravenous treatment (primary endpoint) and end of all treatment and all-cause mortality up to the 6 week follow-up visit is shown in Table 5.
Slovenian: Delež uspešnega globalnega odziva na koncu intravenskega zdravljenja (primarni opazovani dogodek) in na koncu celotnega zdravljenja ter umrljivost zaradi vseh vzrokov do kontrolnega obiska v 6. tednu so prikazani v preglednici 5.
English: What you need to know before you use ECALTA
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo ECALTA
English: Anidulafungin has shown fungicidal activity against Candida species and activity against regions of active cell growth of the hyphae of Aspergillus fumigatus.
Slovenian: Anidulafungin je pokazal fungicidno delovanje proti vrstam Candida ter delovanje proti predelom aktivne celične rasti hif Aspergillus fumigatus.
English: The infection is caused by fungal cells (yeasts) called Candida.
Slovenian: Okužbo povzročajo glivice (kvasovke), imenovane Candida.
English: In the clinical trials the outcome for anidulafungin with C. parapsilosis was not statistically different from other species however, the use of echinocandins in candidaemia due to C. parapsilosis may not be regarded as therapy of first choice
Slovenian: V kliničnih preskušanjih se izid za anidulafungin pri C. parapsilosis ni statistično razlikoval od drugih vrst, vendar pa se uporaba ehinokandinov za zdravljenje kandidemije zaradi C.parapsilosis ne more smatrati kot zdravljenje prve izbire.
English: The population pharmacokinetic analysis showed that median clearance differed slightly between the elderly group (patients ≥ 65, median CL = 1.07 l/h) and the non-elderly group (patients < 65, median CL = 1.22 l/h), however the range of clearance was similar.
Slovenian: Analiza populacijske farmakokinetike je pokazala, da se mediani očistek rahlo razlikuje med starejšo (bolniki ≥ 65 let, mediani očistek = 1,07 l/h) in nestarejšo skupino (bolniki < 65 let, mediani očistek = 1,22 l/h), toda razpon očistkov je bil podoben.
English: Infusion solution concentration is 0.77 mg/mL
Slovenian: Koncentracija infuzijske raztopine je 0,77 mg/ml.
English: Dosage adjustments are not required based on HIV positivity, irrespective of concomitant antiretroviral therapy.
Slovenian: Prilagoditev odmerjanja pri HIV-pozitivnih bolnikih ni potrebna, ne glede na sočasno protiretrovirusno zdravljenje.
English: In general, your treatment should continue for at least 14 days after the last day Candida was found in your blood.
Slovenian: Praviloma boste morali zdravilo dobivati vsaj še 14 dni po dnevu, ko so vam v krvi zadnjič našli Candido.
English: However, brain concentrations increased in uninfected neonatal rats after five daily doses (brain to plasma ratio of approximately 0.7).
Slovenian: Vendar pa se je koncentracija v možganih pri neokuženih novorojenih podganah po petih dnevnih odmerkih zvišala (razmerje možgani/plazma približno 0,7).
English: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium
Slovenian: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgija
English: Excipient with known effect: Fructose 102.5 mg per vial
Slovenian: Pomožna(e) snov(i) z znanim učinkom: fruktoza, 102,5 mg na vialo
English: This results in inhibition of the formation of 1,3--D-glucan, an essential component of the fungal cell wall.
Slovenian: Posledica je zavrtje nastajanja 1,3--D-glukana, nujne sestavine celične stene glivic.
English: Therefore, no information is available about the penetration of anidulafungin into the cerebrospinal fluid (CSF) and/or across the blood-brain barrier.
Slovenian: Informacij o prehajanju anidulafungina v cerebrospinalni likvor in/ali preko krvno-možganske pregrade zato ni na voljo.
English: In the primary efficacy analysis, global response in the MITT populations at the end of intravenous therapy, anidulafungin was compared to fluconazole in a pre-specified twostep statistical comparison (non-inferiority followed by superiority).
Slovenian: V primarni analizi učinkovitosti, globalnem odzivu populacij MITT na koncu intravenskega zdravljenja, so anidulafungin primerjali s flukonazolom z vnaprej opredeljeno dvostopenjsko statistično primerjavo (neinferiornosti in zatem superiornosti).
English: Although a slight decrease in AUC was observed in patients with Child-Pugh C hepatic insufficiency, the decrease was within the range of population estimates noted for healthy subjects.
Slovenian: Čeprav so pri bolnikih z okvaro jeter razreda C po Child-Pughu opazili rahlo zmanjšanje AUC, je bilo to zmanjšanje v območju populacijskih ocen, ugotovljenih pri zdravih preskušancih.
English: This will be followed by a daily dose of 100 mg (maintenance dose).
Slovenian: Temu sledijo dnevni odmerki po 100 mg (vzdrževalni odmerek).
English: 3 or WBC ≤ 500 cells/mm
Slovenian: ≤ 500 celic/mm
English: The treatment starts with 200 mg on the first day (loading dose).
Slovenian: Zdravljenje se začne z odmerkom 200 mg prvi dan (polnilni odmerek).
English: Patients were treated for at least 14 days.
Slovenian: Bolnike so zdravili najmanj 14 dni.
English: Your doctor may prescribe another medicine following your treatment with ECALTA to continue treating your fungal infection or prevent it from returning.
Slovenian: Zdravnik vam lahko po zdravljenju z zdravilom ECALTA predpiše drugo zdravilo, da bi vašo glivično okužbo zdravil naprej oziroma da bi preprečil njeno ponovitev.
English: If your original symptoms come back, tell your doctor or another healthcare professional immediately.
Slovenian: Če se vam začetni simptomi ponovijo, morate to nemudoma povedati zdravniku ali drugemu zdravstvenemu delavcu.
English: The pharmacokinetics of anidulafungin after at least 5 daily doses were investigated in 24 immunocompromised paediatric (2 to 11 years old) and adolescent (12 to 17 years old) patients with neutropenia.
Slovenian: Farmakokinetiko anidulafungina po vsaj 5 dnevnih odmerkih so raziskali pri 24 imunsko oslabelih, nevtropeničnih otrocih (starost od 2 do 11 let) in mladostnikih (od 12 do 17 let).
English: Aseptically reconstitute each vial with 30 mL water for injections to provide a concentration of 3.33 mg/mL.
Slovenian: Aseptično rekonstituirajte vsako vialo s 30 ml vode za injekcije, da dobite koncentracijo 3,33 mg/ml.
English: In 3 month studies, evidence of liver toxicity, including elevated enzymes and morphologic alterations, was observed in both rats and monkeys at doses 4- to 6-fold higher than the anticipated clinical therapeutic exposure.
Slovenian: V 3-mesečnih študijah so pri podganah in opicah opažali znake toksičnih učinkov na jetra, vključno z zvišanjem encimov in morfološkimi spremembami, pri odmerkih, ki so bili od 4- do 6-krat večji od predvidene klinične terapevtske izpostavljenosti.
English: There were no adverse reactions in the low-dose animals in the presence or absence of anaesthesia, and no infusion-related reactions in the mid-dose group in the absence of anaesthesia.
Slovenian: V nizkoodmerni skupini živali ni bilo neželenih reakcij ne z anestezijo ne brez nje, v srednjeodmerni skupini pa brez anestezije ni bilo z infundiranjem povezanih reakcij.
English: The pharmacokinetics of anidulafungin have been characterised in healthy subjects, special populations and patients.
Slovenian: Farmakokinetiko anidulafungina so raziskali pri zdravih osebah, posebnih populacijah in bolnikih.
English: Some rats in the mid dose group experienced similar reactions but only after administration of anaesthesia.
Slovenian: Pri nekaterih podganah v srednjeodmerni skupini so se pojavile podobne reakcije, vendar šele po uporabi anestezije.
English: Anidulafungin undergoes slow chemical degradation at physiologic temperature and pH to a ringopened peptide that lacks antifungal activity.
Slovenian: Anidulafungin je pri fiziološki temperaturi in pH podvržen počasni kemični razgradnji v peptid z odprtim obročem, ki nima protiglivičnega delovanja.
English: The pharmacokinetics of anidulafungin are characterised by a rapid distribution half-life (0.5-1 hour) and a volume of distribution, 30-50 l, which is similar to total body fluid volume.
Slovenian: Za farmakokinetiko anidulafungina sta značilna kratek razpolovni čas porazdelitve (0,5-1 uro) in volumen porazdelitve 30-50 l, kar je podobno celotnemu volumnu tekočine v telesu.
English: The in vitro degradation half-life of anidulafungin under physiologic conditions is approximately 24 hours.
Slovenian: Razpolovni čas razgradnje anidulafungina v fizioloških razmerah je in vitro približno 24 ur.
English: Anidulafungin is a semi-synthetic echinocandin, a lipopeptide synthesised from a fermentation product of Aspergillus nidulans.
Slovenian: Anidulafungin je polsintezni ehinokandin, lipopeptid, sintetiziran iz fermentacijskega produkta Aspergillus nidulans.
English: All patients were treated for at least 14 days.
Slovenian: Vse bolnike so zdravili najmanj 14 dni.
English: ECALTA must not be administered as a bolus injection.
Slovenian: Zdravila ECALTA se ne sme aplicirati v bolusni injekciji.
English: It is unknown whether anidulafungin is excreted in human milk.
Slovenian: Ni znano, ali se anidulafungin izloča v materino mleko.
English: The steady state was achieved on the first day after a loading dose (twice the daily maintenance dose).
Slovenian: Stanje dinamičnega ravnovesja je bilo doseženo prvi dan po polnilnem odmerku (dvakratni dnevni vzdrževalni odmerek).
English: In vivo, the ring-opened product is subsequently converted to peptidic degradants and eliminated mainly through biliary excretion.
Slovenian: In vivo se produkt z odprtim obročem nato pretvori v peptidne razgradne produkte in izloči pretežno z žolčem.
English: Patients with increased hepatic enzymes during anidulafungin therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing anidulafungin therapy.
Slovenian: Bolnike, pri katerih se med zdravljenjem z anidulafunginom pojavi zvišana raven jetrnih encimov, je treba spremljati glede znakov slabšanja delovanja jeter in pri njih oceniti koristi in tveganja nadaljnjega zdravljenja z anidulafunginom.
English: Anidulafungin exhibited in-vitro activity against C. albicans, C. glabrata, C. parapsilosis, C. krusei and C. tropicalis.
Slovenian: Anidulafungin in vitro deluje proti C. albicans, C. glabrata, C. parapsilosis, C. krusei in C. tropicalis.
English: There are no data from the use of anidulafungin in pregnant women.
Slovenian: Podatkov o uporabi anidulafungina pri nosečnicah ni.
English: 3 at baseline) with invasive candidiasis was assessed in a prospective, double-blind, randomized, controlled trial.
Slovenian: 3 ob izhodišču) z invazivno kandidozo so ocenili v prospektivnem, dvojno slepem, randomiziranem, nadzorovanem preskušanju.
English: In a clinical study of subjects with mild, moderate, severe or end stage (dialysis-dependent) renal insufficiency, anidulafungin pharmacokinetics were similar to those observed in subjects with normal renal function.
Slovenian: V kliničnem preskušanju s preskušanci z blago, zmerno, hudo ali končno (od dialize odvisno) okvaro ledvic je bila farmakokinetika anidulafungina podobna kot pri preskušancih z normalnim delovanjem ledvic.
English: What ECALTA is and what it is used for What you need to know before you use ECALTA How to use ECALTA
Slovenian: Kaj je zdravilo ECALTA in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo ECALTA Kako uporabljati zdravilo ECALTA Možni neželeni učinki
English: Embryo-foetal development studies were conducted with doses between 0.2- and 2-fold (rats) and between 1- and 4-fold (rabbits) the proposed therapeutic maintenance dose of 100 mg/day.
Slovenian: Embrio-fetalne razvojne študije so bile opravljene z odmerki, ki so bili od 0,2- do 2-kratnik (podgane) oz. od 1- do 4-kratnik (kunci) predvidenega terapevtskega vzdrževalnega odmerka 100 mg/dan.
English: However, in animal experiments these mutations confer cross resistance to all three echinocandins and therefore such isolates are classified as echinocandin resistant until further clinical experience are obtained concerning anidulafungin.
Slovenian: Vendar so z eksperimenti na živalih pokazali, da te mutacije povzročijo navzkrižno odpornost na vse tri ehinokandine, zato so take izolate do pridobitve dodatnih kliničnih izkušenj z anidulafunginom razvrstili kot odporne proti ehinookandinom..
English: Steady state was achieved on the first day after a loading dose (twice the maintenance dose), and steady state Cmax and AUCss increase in a dose-proportional manner.
Slovenian: Stanje dinamičnega ravnovesja je bilo doseženo prvi dan po polnilnem odmerku (dvakratni vzdrževalni odmerek), Cmax in AUCss v stanju dinamičnega ravnovesja pa se povečujeta sorazmerno z odmerkom.
English: Anidulafungin pharmacokinetics were examined in subjects with Child-Pugh class A, B or C hepatic insufficiency.
Slovenian: Farmakokinetiko anidulafungina so raziskali pri preskušancih z okvaro jeter razredov A, B in C po Child-Pughu.
English: Anidulafungin crossed the placental barrier in rats and was detected in foetal plasma.
Slovenian: Anidulafungin je pri podganah prehajal skozi placentno pregrado in so ga našli v plazmi plodov.
English: Pack size of 1 vial.
Slovenian: Škatla z 1 vialo.
English: ECALTA belongs to a group of medicines called echinocandins.
Slovenian: Zdravilo ECALTA sodi v skupino zdravil, imenovanih ehinokandini.
English: The following information is intended for medical or healthcare professionals only and applies only to the single vial ECALTA 100 mg powder for concentrate for solution for infusion presentation:
Slovenian: Naslednje informacije so namenjene samo zdravstvenim delavcem in veljajo samo za pakiranje z eno vialo zdravila ECALTA 100 mg prašek za koncentrat za raztopino za infundiranje:
English: The successful global response rate at End of Intravenous Treatment (primary endpoint) was 26/46 (56.5%) and End of All Treatment was 24/46 (52.2%).
Slovenian: Delež uspešnega globalnega odziva na koncu intravenskega zdravljenja (primarni opazovani dogodek) je bil 26/46 (56,5 %) in na koncu celotnega zdravljenja 24/46 (52,2 %).
English: The reconstituted solution contains 3.33 mg/mL anidulafungin and the diluted solution contains 0.77 mg/mL anidulafungin.
Slovenian: Rekonstituirana raztopina vsebuje 3,33 mg/ml anidulafungina, razredčena raztopina pa 0,77 mg/ml anidulafungina.
English: Drug interaction studies were performed with anidulafungin and other medicinal products likely to be co-administered.
Slovenian: Študije medsebojnega delovanja so izvedli z anidulafunginom in drugimi zdravili, za katera je sočasna uporaba z njim verjetna.
English: What ECALTA looks like and contents of the pack
Slovenian: Izgled zdravila ECALTA in vsebina pakiranja
English: - Convulsion (seizure) - Headache - Vomiting - Changes in blood tests of liver function - Rash, pruritis (itching) - Changes in blood tests of kidney function - Abnormal flow of bile from the gallbladder into the intestine (cholestasis) - High blood sugar - High blood pressure - Low blood pressure - Sudden contraction of the muscles around the airways resulting in wheezing or coughing - Difficulty of breathing
Slovenian: - konvulzije (napadi krčev) - glavobol - bruhanje - spremembe v izvidih krvnih preiskav delovanja jeter - izpuščaj, pruritus (srbenje) - spremembe v izvidih krvnih preiskav delovanja ledvic - nenormalnosti pri iztekanju žolča iz žolčnika v črevo (holestaza) - visoka raven sladkorja v krvi - visok krvni tlak - nizek krvni tlak - nenadno skrčenje mišic okrog dihalnih poti, ki se kaže kot piskajoče dihanje ali kašljanje - oteženo dihanje
English: Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Slovenian: Parenteralna zdravila je treba pred uporabo vizualno pregledati, da ne vsebujejo delcev in niso obarvana, kadarkoli raztopina in vsebnik dopuščata takšen pregled.
English: Excursions for 96 hours up to 25ºC are permitted, and the powder can be returned to refrigerated storage.
Slovenian: Odkloni temperature za 96 ur do temperature 25 ºC so dovoljeni, prašek pa lahko potem ponovno shranjujete v hladilniku.
English: Mortality rates in both the anidulafungin and fluconazole arms are presented below in Table 4:
Slovenian: Stopnje umrljivosti v krakih z anidulafunginom in flukonazolom so zajete v preglednici 4, spodaj:
English: Each vial contains 100 mg anidulafungin.
Slovenian: Ena viala vsebuje 100 mg anidulafungina.
English: Dilution and infusion
Slovenian: Razredčenje in infundiranje
English: Anidulafungin selectively inhibits 1,3-β-D glucan synthase, an enzyme present in fungal, but not mammalian cells.
Slovenian: Anidulafungin selektivno zavre 1,3--D-glukan-sintazo, encim, ki je prisoten v celicah gliv, ne pa tudi v celicah sesalcev.
English: All-cause mortality up to the end of the study (6 Week Follow-up Visit) was 21/46 (45.7%).
Slovenian: Umrljivost zaradi vseh vzrokov je bila do konca preskušanja (kontrolni obisk v 6. tednu) 21/46 (45,7 %).
English: For instructions on reconstitution of the medicinal product before administration (see section 6.6).
Slovenian: Za navodila glede rekonstitucije zdravila pred dajanjem glejte poglavje 6.6.
English: The most common pathogens isolated at baseline were C. tropicalis (4 anidulafungin, 0 caspofungin), C. parapsilosis (2 anidulafungin, 1 caspofungin), C. krusei (2 anidulafungin, 1 caspofungin), and C. ciferrii (2 anidulafungin, 0 caspofungin).
Slovenian: Najpogosteje izolirani patogeni ob izhodišču so bili C. tropicalis (4 anidulafungin, 0 kaspofungin), C. parapsilosis (2 anidulafungin, 1 kaspofungin), C. krusei (2 anidulafungin, 1 kaspofungin) in C. ciferrii (2 anidulafungin, 0 kaspofungin).
English: - Disorder of blood clotting system - Flushing - Hot flush - Stomach pain - Hives - Pain at injection site
Slovenian: - motnje strjevanja krvi - pordevanje - vročinski oblivi - bolečine v želodcu - koprivnica - bolečina na mestu injiciranja
English: 30 mL Type 1 glass vial with an elastomeric stopper (butyl rubber with an inert polymer coating on the product contact surface and lubricant on the top surface for easier machinability, or alternatively bromobutyl rubber with a lubricant) and aluminium seal with flip-off cap.
Slovenian: 30 ml steklena viala iz stekla tipa I z elastomernim zamaškom (butilna guma prevlečena z inertno polimerno plastjo na stični površini zamaška in mazivom na zgornji površini za lažjo strojno obdelavo, ali alternativno bromobutilna guma z mazivom) in aluminijsko zaporo s snemljivo zaporko.
English: The successful global response rate at the End of Intravenous Treatment (primary endpoint) was 8/11 (72.7%) for anidulafungin and 3/3 (100.0%) for caspofungin (difference -27.3, 95% CI -80.9, 40.3); the successful global response rate at the End of All Treatment was 8/11 (72.7%) for anidulafungin and 3/3 (100.0%) for caspofungin (difference -27.3, 95% CI -80.9, 40.3).
Slovenian: Delež uspešnega globalnega odziva na koncu intravenskega zdravljenja (primarni opazovani dogodek) za anidulafungin je bil 8/11 (72,7 %), za kaspofungin pa 3/3 (100,0 %) (razlika -27,3, 95 % IZ -80,9, 40,3); delež uspešnega globalnega odziva na koncu celotnega zdravljenja za anidulafungin je bil 8/11 (72,7 %), za kaspofungin pa 3/3 (100,0 %) (razlika -27,3, 95 % IZ -80,9, 40,3).
English: Dose Number of vials of powder
Slovenian: Odmerek Število vial s praškom
English: The pharmacokinetics of anidulafungin in patients with fungal infections are similar to those observed in healthy subjects based on population pharmacokinetic analyses.
Slovenian: Pri bolnikih z glivičnimi okužbami je farmakokinetika anidulafungina podobna farmakokinetiki pri zdravih preskušancih, ugotovljeni na podlagi analiz populacijske farmakokinetike.
English: Patients with fungal infections
Slovenian: Bolniki z glivičnimi okužbami
English: From a microbiological point of view, following good aseptic practices, the infusion solution can be utilized for up to 48 hours from preparation when stored at 25ºC.
Slovenian: Z mikrobiološkega vidika in v skladu z dobro aseptično prakso je raztopina za infundiranje lahko uporabna do 48 ur od priprave, če jo hranimo pri 25 °C.
English: Candidaemia and other forms of Invasive Candidiasis The safety and efficacy of anidulafungin were evaluated in a pivotal Phase 3, randomised, doubleblind, multicentre, multinational study of primarily non-neutropenic patients with candidaemia and a limited number of patients with deep tissue Candida infections or with abscess-forming disease.
Slovenian: Varnost in učinkovitost anidulafungina so ocenili v ključnem, randomiziranem, dvojno slepem, multicentričnem, multinacionalnem preskušanju 3. faze s predvsem nenevtropeničnimi bolniki s kandidemijo ter omejenim številom bolnikov z okužbami globokih tkiv s Candido ali bolnikov z boleznijo, povezano z nastajanjem abscesov.
English: A total of 14 neutropenic patients with microbiologically confirmed invasive candidiasis (MITT population) were enrolled in the study (11 anidulafungin; 3 caspofungin).
Slovenian: V preskušanje so vključili skupno 14 nevtropeničnih bolnikov z mikrobiološko potrjeno invazivno kandidozo (populacija MITT) (11 jih je prejemalo anidulafungin, 3 pa kaspofungin).
English: Experimental infections included disseminated C. albicans infection in neutropenic rabbits, oesophageal/oropharyngeal infection of neutropenic rabbits with fluconazole-resistant C. albicans and disseminated infection of neutropenic mice with fluconazole-resistant C. glabrata.
Slovenian: Med eksperimentalnimi okužbami so bile diseminirana okužba s C. albicans pri nevtropeničnih kuncih, okužba požiralnika/orofarinksa s C. albicans, odporno proti flukonazolu, pri nevtropeničnih kuncih ter diseminirana okužba s C. glabrato, odporno proti flukonazolu, pri nevtropeničnih miših.
English: ECALTA has not been studied in patients with Candida endocarditis, osteomyelitis or meningitis.
Slovenian: Zdravila ECALTA niso proučevali pri bolnikih z endokarditisom, osteomielitisom ali meningitisom, povzročenimi s Candido.