FrancophonIA/ELRC3.0 huggingface dataset:
English: Anidulafungin treatment prolonged survival and also reduced the organ burden of Candida species, when determined at intervals from 24 to 96 hours after the last treatment.
Croatian: Liječenje anidulafunginom produljilo je preživljenje i također smanjilo količinu vrsta iz roda Candida u organima, određivanu u vremenskim razmacima od 24 do 96 sati nakon zadnje primjene lijeka.
English: All patients were treated for at least 14 days.
Croatian: Svi bolesnici su bili liječeni tijekom najmanje 14 dana.
English: During clinical trials, a single 400 mg dose of anidulafungin was inadvertently administered as a loading dose.
Croatian: Tijekom kliničkih ispitivanja, nehotično je bila primijenjena jednokratna doza od 400 mg anidulafungina kao udarna doza.
English: All-cause mortality up to the end of the study (6 Week Follow-up Visit) was 21/46 (45.7%).
Croatian: Mortalitet zbog svih uzroka do kraja ispitivanja (posjeta u 6. tjednu praćenja) bio je 21/46 (45,7%).
English: Anidulafungin pharmacokinetics were examined in subjects with Child-Pugh class A, B or C hepatic insufficiency.
Croatian: Farmakokinetika anidulafungina ispitana je u bolesnika s Child-Pugh stadijem A, B ili C insuficijencije jetre.
English: Global Response of Success at EOT All-Cause Mortality
Croatian: Opći odgovor uspjeha pri EOT Smrtnost zbog svih uzroka
English: Efficacy data, both overall and by various subgroups, are presented below in Table 3.
Croatian: Podaci o djelotvornosti kod svih ispitanika i u raznim podskupinama bolesnika prikazani su u tablici 3.
English: Parenterally administered anidulafungin was effective against Candida species in immunocompetent and immunocompromised mouse and rabbit models.
Croatian: Parenteralno primijenjeni anidulafungin pokazao se djelotvornim protiv vrsta iz roda Candida na modelu imunokompetentnih i imunokompromitiranih miševa i kunića.
English: Two hundred and fifty-six patients, ranging from 16 to 91 years in age, were randomised to treatment and received at least one dose of study medication.
Croatian: Dvjesto pedeset i šest (256) bolesnika u dobi od 16 do 91 godine dobilo je najmanje jednu dozu ispitivanog lijeka nakon randomizacije u različite terapijske skupine.
English: A standardized technique for testing the susceptibility of Candida species to anidulafungin as well as the respective interpretative breakpoints has been established by European Committee on Antimicrobial Susceptibility Testing (EUCAST).
Croatian: Standardizirana metoda ispitivanja osjetljivosti vrsta iz roda Candida na anidulafungin, kao i pripadajuće granične vrijednosti određene su od strane Europskog povjerenstva za ispitivanje antimikrobne osjetljivosti (EUCAST).
English: However, brain concentrations increased in uninfected neonatal rats after five daily doses (brain to plasma ratio of approximately 0.7).
Croatian: Međutim, koncentracije u mozgu povisile su se u neinficiranih tek okoćenih štakora nakon pet dnevnih doza (omjer koncentracije u mozgu i plazmi iznosio je približno 0,7).
English: If you stop using ECALTA You should not experience any effects from ECALTA if your doctor stops ECALTA treatment.
Croatian: Ne biste trebali osjetiti nikakve učinke lijeka ECALTA ako Vam liječnik prekine liječenje lijekom ECALTA.
English: Systemic exposure following daily maintenance dose of 0.75 and 1.5 mg/kg/day in this population were comparable to those observed in adults following 50 and 100 mg/day, respectively.
Croatian: Sustavna izloženost lijeku nakon primjene doze održavanja od 0,75 i 1,5 mg/kg/dan u ovoj je populaciji bila usporediva s onom u odraslih nakon primjene 50 odnosno 100 mg/dan.
English: Infusion solution concentration is 0.77 mg/mL
Croatian: Koncentracija otopine za infuziju je 0,77 mg/ml.
English: Dilution and infusion
Croatian: Razrjeđivanje i infuzija
English: C) anidulafungin (~88 mg) was administered to healthy subjects.
Croatian: C) anidulafungin (~88 mg).
English: The in vitro activity of anidulafungin against Candida species is not uniform.
Croatian: In vitro aktivnost anidulafungina protiv vrsta iz roda Candida nije ujednačena.
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon pripremanja i razrjeđivanja lijeka, vidjeti u dijelu 6.3.
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.
Croatian: Farmakokinetiku anidulafungina obilježava brzo poluvrijeme distribucije (0,5 do 1 sat) i volumen distribucije od 30-50 l, što je slično ukupnom volumenu tjelesne tekućine.
English: ECALTA contains fructose
Croatian: ECALTA sadrži fruktozu
English: Patients with fungal infections
Croatian: Bolesnici s gljivičnim infekcijama
English: Patients were treated for at least 14 days.
Croatian: Bolesnici su bili liječeni tijekom najmanje 14 dana.
English: Pack size of 1 vial.
Croatian: Veličina pakiranja 1 bočica.
English: Do not use ECALTA - if you are allergic to anidulafungin, other echinocandins (e.g.caspofungin acetate), or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na anidulafungin, druge ehinokandine (npr. kaspofungin acetat), ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: 3 at baseline) with invasive candidiasis was assessed in a prospective, double-blind, randomized, controlled trial.
Croatian: 3 na početku) s invazivnom kandidijazom bili su procijenjeni u prospektivnom, dvostruko slijepom, randomiziranom, kontroliranom ispitivanju.
English: Anidulafungin is a semi-synthetic echinocandin, a lipopeptide synthesised from a fermentation product of Aspergillus nidulans.
Croatian: Anidulafungin je polusintetski ehinokandin, lipopeptid sintetiziran iz fermentacijskih produkata Aspergillus nidulans.
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.
Croatian: Iako je u populacijskoj farmakokinetičkoj analizi tjelesna težina prepoznata kao izvor varijabilnosti klirensa, tjelesna težina ima vrlo malu kliničku važnost na farmakokinetiku anidulafungina.
English: Dosage adjustments are not required based on HIV positivity, irrespective of concomitant antiretroviral therapy.
Croatian: Nije potrebna prilagodba doze u HIV-pozitivnih bolesnika, bez obzira na istovremenu primjenu antiretrovirusnih lijekova.
English: Excipients: fructose, mannitol, polysorbate 80, tartaric acid, NaOH and/or HCl.
Croatian: Pomoćne tvari: fruktoza, manitol, polisorbat 80, tartaratna kiselina, NaOH i/ili HCl.
English: Cases of significant hepatic dysfunction, hepatitis, and hepatic failure were uncommon in clinical trials.
Croatian: Slučajevi značajnog poremećaja funkcije jetre, hepatitisa i zatajenje jetre nisu bili česti u kliničkim ispitivanjima.
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.
Croatian: Iako je uočeno lagano sniženje AUC kod bolesnika s Child-Pugh stadijem C insuficijencije jetre, to je sniženje bilo unutar procijenjenog raspona za populaciju zabilježenog kod zdravih ispitanika.
English: Patients with Candida endocarditis, osteomyelitis or meningitis, or those with infection due to C. krusei, were specifically excluded from the study.
Croatian: Bolesnici s endokarditisom, osteomijelitisom ili meningitisom izazvanima Candidom, kao i oni s infekcijom uzrokovanim C. krusei, bili su posebno isključeni iz ispitivanja.
English: Anidulafungin is not dialysable and may be administered without regard to the timing of hemodialysis.
Croatian: Anidulafungin nije podložan dijalizi i može se primjenjivati bez obzira na vrijeme hemodijalize.
English: Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of anidulafungin.
Croatian: Nisu provedena dugotrajna ispitivanja na životinjama zbog procjene kancerogenosti anidulafungina.
English: Talk to your doctor or pharmacist or nurse before using ECALTA.
Croatian: Obratite se svom liječniku ili ljekarniku ili medicinskoj sestri prije nego primijenite lijek ECALTA.
English: 3 or WBC ≤ 500 cells/mm
Croatian: 3, leukociti ≤ 500 stanica/mm
English: What you need to know before you use ECALTA
Croatian: Što morate znati prije nego počnete primjenjivati lijek ECALTA
English: Developmental effects observed in rabbits (slightly reduced foetal weights) occurred only at the highest dose tested, a dose that also produced maternal toxicity.
Croatian: Poremećaji razvoja uočeni kod kunića (blago smanjena fetalna težina) nastali su samo kod primjene najviše ispitivane doze, koja je ujedno imala toksične učinke za majku.
English: Alanine aminotransferase increased, blood alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholestasis
Croatian: Povišene vrijednosti alanin aminotransferaz e, povišene vrijednosti alkalne fosfataze u krvi, povišene vrijednosti aspartat aminotransferaz e, povišene vrijednosti bilirubina u krvi, kolestaza
English: The steady state was achieved on the first day after a loading dose (twice the daily maintenance dose).
Croatian: Stanje dinamičke ravnoteže postiže se već prvoga dana nakon primjene udarne doze (dvostruko veća od dnevne doze održavanja).
English: Ask your doctor or pharmacist for advice before taking any medicines.
Croatian: Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.
English: ECALTA is not dialysable.
Croatian: ECALTA se ne može ukloniti dijalizom.
English: The infusion solution may be stored at 25°C (room temperature) for 48 hours or stored frozen for at least 72 hours, and should be administered at 25C (room temperature) within 48 hours.
Croatian: Otopina za infuziju može se čuvati na temperaturi od 25ºC (sobna temperatura) tijekom 48 sati ili zamrznuta tijekom najmanje 72 sata, a treba se primijeniti na temperaturi od 25ºC (sobnoj temperaturi) u roku od 48 sati.
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.
Croatian: Populacijska farmakokinetička analiza pokazala je blagu razliku u medijan klirensa (CL) između starije (bolesnici u dobi od  65 godina, medijan CL = 1,07 l/h) i mlađe dobne skupine (bolesnici u dobi od < 65 godina, medijan CL = 1,22 l/h), međutim, raspon klirensa je bio sličan.
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.
Croatian: Stanje dinamičke ravnoteže postignuto je prvog dana nakon udarne doze (dvostruko viša od doze održavanja), a povećanje Cmax i AUCss u stanju dinamičke ravnoteže bilo je proporcionalno dozi.
English: Minimum duration of infusion
Croatian: Najkraće trajanje infuzije
English: Some rats in the mid dose group experienced similar reactions but only after administration of anaesthesia.
Croatian: Neki štakori iz skupine koja je dobivala srednju dozu imali su slične reakcije, ali samo nakon primjene anestezije.
English: The effect of ECALTA in pregnant women is not known.
Croatian: Učinak lijeka ECALTA na trudnice nije poznat.
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.
Croatian: Pokusni modeli infekcija uključivali su diseminiranu infekciju C. albicans kod neutropeničnih kunića, ezofagealnu/orofaringealnu infekciju neutropeničnih kunića s flukonazol-rezistentnom C. albicans i diseminiranu infekciju neutropeničnih miševa s flukonazol-rezistentnom C. glabrata.
English: ECALTA can be given without regard to the timing of haemodialysis (see section 5.2).
Croatian: ECALTA se može dati neovisno o vremenu kad se provodi hemodijaliza (vidjeti dio 5.2).
English: Negligible amounts of drug-derived radioactivity were recovered in blood, urine, and faeces 8 weeks post-dose.
Croatian: Zanemarive količine radioaktivnosti prouzročene lijekom zabilježene su u krvi, mokraći i stolici 8 tjedana nakon primjene doze.
English: There are no data from the use of anidulafungin in pregnant women.
Croatian: Nema podataka o primjeni anidulafungina u trudnica.
English: 3 in 22 patients or classified by the investigator as neutropenic at baseline in 13 patients.
Croatian: 3 u 22 bolesnika ili klasificiranom od strane ispitivača kao neutropenijom u 13 bolesnika prije početka liječenja.
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.
Croatian: Bolesnicima u obje skupine bilo je dopušteno prijeći na peroralni oblik flukonazola nakon najmanje 10 dana intravenske terapije, pod uvjetom da su mogli primati lijek kroz usta, da nisu imali vrućicu najmanje 24 sata i da su zadnje hemokulture bile negativne na vrste Candida.
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.
Croatian: U ispitivanjima u trajanju od 3 mjeseca u štakora i majmuna opaženi su znakovi toksičnog oštećenja jetre, uključujući povišenje enzima i morfološke promjene, kod primjene doza 4-6 puta viših od očekivane kliničke terapijske izloženosti.
English: Anidulafungin has negligible renal clearance (<1%).
Croatian: Bubrežni klirens anidulafungina je zanemariv (<1%).
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:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima i vrijede samo za jednu bočicu lijeka ECALTA 100 mg prašak za koncentrat za otopinu za infuziju:
English: The infection is caused by fungal cells (yeasts) called Candida.
Croatian: Tu infekciju uzrokuje gljivica koja se zove Candida.
English: Specifically, for C. parapsilosis, the MICs of anidulafungin are higher than are those of other Candida species.
Croatian: Konkretno, za C. parapsilosis minimalne inhibitorne koncentracije anidulafungina više su od onih za druge vrste iz roda Candida.
English: ECALTA has not been studied in patients with Candida endocarditis, osteomyelitis or meningitis.
Croatian: ECALTA nije ispitivana u bolesnika s endokarditisom, osteomijelitisom ili meningitisom uzrokovanima Candidom.
English: Fructose content
Croatian: Sadržaj fruktoze
English: Anidulafungin did not produce any drug-related developmental toxicity in rats at the highest dose tested.
Croatian: Kod štakora anidulafungin nije proizveo nikakvu razvojnu toksičnost povezanu s primjenom lijeka niti kod primjene najviše ispitane doze.
English: ECALTA should be reconstituted with water for injections to a concentration of 3.33 mg/mL and subsequently diluted to a concentration of 0.77 mg/mL.
Croatian: ECALTA se treba rekonstituirati s vodom za injekcije do koncentracije od 3,33 mg/ml i zatim razrijediti do koncentracije od 0,77 mg/ml.
English: In vitro and in vivo genotoxicity studies with anidulafungin provided no evidence of genotoxic potential.
Croatian: In vitro i in vivo ispitivanja genotoksičnosti anidulafungina nisu pokazala genotoksičnost.
English: Anidulafungin concentrations were not increased in subjects with any degree of hepatic insufficiency.
Croatian: Koncentracije anidulafungina nisu bile povišene niti kod jednog stupnja insuficijencije jetre.
English: No dosing adjustments are required for patients with mild, moderate, or severe hepatic impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije jetre.
English: - Low blood potassium (hypokalaemia) - Diarrhoea - Nausea
Croatian: - niska razina kalija u krvi (hipokalijemija) - proljev - mučnina
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.
Croatian: U kliničkom ispitivanju u ispitanika s blagim, umjerenim, teškim i terminalnim zatajenjem bubrega (na dijalizi), farmakokinetika anidulafungina bila je slična onoj opaženoj u ispitanika s normalnom funkcijom bubrega.
English: Mortality Anidulafungin Fluconazole
Croatian: Tablica 4. Smrtnost Anidulafungin Flukonazol
English: Anidulafungin selectively inhibits 1,3-β-D glucan synthase, an enzyme present in fungal, but not mammalian cells.
Croatian: Anidulafungin selektivno inhibira 1,3-β-D glukan sintetazu, enzim koji je prisutan u stanicama gljivica, ali ne i stanicama sisavaca.
English: No dosage adjustment of either medicinal product is recommended when anidulafungin is co-administered with ciclosporin, voriconazole or tacrolimus, and no dosage adjustment for anidulafungin is recommended when co-administered with amphotericin B or rifampicin.
Croatian: Ne preporučuje se prilagodba doze ciklosporina, vorikonazola ili takrolimusa kad se primjenjuju istovremeno s anidulafunginom, kao što se ne preporučuje niti prilagodba doze anidulafungina kad se primjenjuje istovremeno s amfotericinom B ili rifampicinom.
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.
Croatian: Ispitivanja utjecaja na embrio-fetalni razvoj provedena su s dozama između 0,2 i 2 puta (štakori) te između 1 i 4 puta (kunići) višima od predložene terapijske doze održavanja od 100 mg na dan.
English: Increased levels of hepatic enzymes have been seen in healthy subjects and patients treated with anidulafungin.
Croatian: Povišene razine jetrenih enzima opažene su u zdravih ispitanika i bolesnika liječenih anidulafunginom.
English: The pharmacokinetics of anidulafungin have been characterised in healthy subjects, special populations and patients.
Croatian: Farmakokinetika anidulafungina opisana je kod zdravih ispitanika, posebnih skupina i bolesnika.
English: For anidulafungin, there were no effects on fertility in studies conducted in male and female rats (see section 5.3).
Croatian: Anidulafungin nije pokazao djelovanje na plodnost u ispitivanjima provedenim na mužjacima i ženkama štakora (vidjeti dio 5.3).
English: Patients with microbiologically confirmed invasive candidiasis (MITT population) and neutropenia were identified in an analysis of pooled data from 4 similarly designed prospective, open-label, noncomparative studies.
Croatian: Bolesnici s mikrobiološki potvrđenom invazivnom kandidijazom (MITT populacija) i neutropenijom identificirani su u analizi udruženih podataka iz 4 slično dizajnirana, prospektivna, otvorena, nekomparativna ispitivanja.
English: End of IV Therapy (1º endpoint) Candidaemia only Other sterile sites Peritoneal fluid/IA c abscess
Croatian: Kraj i.v. terapije (primarni ishod) Samo kandidemija Druga sterilna mjesta peritonejska tekućina/IA c apsces ostalo
English: Less than 1% of the administered radioactive dose was excreted in the urine, indicating negligible renal clearance.
Croatian: Manje od 1% primijenjene doze radioaktivno obilježenog lijeka izlučeno je u mokraći, što ukazuje na zanemariv bubrežni klirens.
English: Effective contraception should be used in women of childbearing age.
Croatian: Žene generativne dobi trebaju koristiti učinkovitu kontracepciju.
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.
Croatian: Bolesnike s povišenim vrijednostima jetrenih enzima tijekom terapije anidulafunginom treba pratiti zbog znakova pogoršanja funkcije jetre te procijeniti omjer rizika i koristi od nastavka terapije anidulafunginom.
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.
Croatian: Sigurnost primjene i djelotvornost anidulafungina procijenjena je u velikom randomiziranom, dvostruko slijepom, multicentričnom, multinacionalnom ispitivanju faze III i to prvenstveno na bolesnicima s kandidemijom bez neutropenije i na ograničenom broju bolesnika s infekcijom dubokih tkiva izazvanom Candidom ili apscedirajućim oblikom bolesti.
English: Bronchospasm, Dyspnoea
Croatian: Bronhospazam, dispneja
English: No dosing adjustments are required for patients with any degree of renal insufficiency, including those on dialysis.
Croatian: Nije potrebna prilagodba doze u bolesnika s bilo kojim stupnjem zatajivanja bubrega, uključujući i one na dijalizi.
English: A total of 14 neutropenic patients with microbiologically confirmed invasive candidiasis (MITT population) were enrolled in the study (11 anidulafungin; 3 caspofungin).
Croatian: U ispitivanje je bilo uključeno ukupno 14 bolesnika s neutropenijom i s mikrobiološki potvrđenom invazivnom kandidijazom (MITT populacija) (11 ih je primalo anidulafungin; 3 ih je primalo kaspofungin).
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).
Croatian: Stopa općeg uspješnog odgovora na kraju intravenskog liječenja (primarna mjera ishoda) iznosila je 8/11 (72,7%) za anidulafungin te 3/3 (100,0%) za kaspofungin (razlika -27,3; 95% CI -80,9; 40,3); stopa uspješnog općeg odgovora na kraju svih liječenja iznosila je 8/11 (72,7%) za anidulafungin te 3/3 (100,0%) za kaspofungin (razlika27,3; 95% CI -80,9; 40,3).
English: The rate of infusion should not exceed 1.1 mg/min (equivalent to 1.4 mL/min when reconstituted and diluted per instructions) (see sections 4.2, 4.4 and 4.8).
Croatian: Brzina infuzije ne smije biti veća od 1,1 mg/min (što odgovara 1,4 ml/min kod pripreme i razrjeđivanja prema uputama) (vidjeti dijelove 4.2, 4.4 i 4.8).
English: Excursions for 96 hours up to 25ºC are permitted, and the powder can be returned to refrigerated storage.
Croatian: Dozvoljeno je odstupanje do temperature od 25ºC u periodu od 96 sati, nakon čega se prašak može ponovno pohraniti u hladnjak.
English: Anidulafungin undergoes slow chemical degradation at physiologic temperature and pH to a ringopened peptide that lacks antifungal activity.
Croatian: Pri fiziološkoj temperaturi i pH, anidulafungin se sporo kemijski degradira do peptida s otvorenim prstenom koji nema antifungalno djelovanje.
English: In some patients with serious underlying medical conditions who were receiving multiple concomitant medicines along with anidulafungin, clinically significant hepatic abnormalities have occurred.
Croatian: U nekih bolesnika s ozbiljnom bolešću u podlozi koji su primali više lijekova istovremeno s anidulafunginom nastupili su klinički značajni poremećaji jetre.