FrancophonIA/ELRC3.0 huggingface dataset:
English: Candida albicans Candida glabrata Candida tropicalis Candida krusei Candida parapsilosis Other Candida spp.
Croatian: Candida albicans Candida glabrata Candida tropicalis Candida krusei Candida parapsilosis druge Candida spp.
English: 98.3% confidence intervals, adjusted post hoc for multiple comparisons of secondary time points.
Croatian: Raspon pouzdanosti od 98,3%, prilagođen post hoc za višestruke usporedbe u sekundarnim vremenskim točkama.
English: A successful global response required clinical improvement and microbiological eradication.
Croatian: Uspješan opći odgovor zahtijevao je kliničko poboljšanje i mikrobiološku eradikaciju.
English: As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Croatian: S obzirom da ćete ovaj lijek primati pod strogim medicinskim nadzorom, nije vjerojatno da bi moglo doći do propuštanja doze.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim bolestima nepodnošenja fruktoze ne smiju uzimati ovaj lijek.
English: C. albicans Non-albicans species
Croatian: C. albicans Ostale vrste (ne albicans)
English: These medicines are used to treat serious fungal infections.
Croatian: Ovi se lijekovi koriste u liječenju ozbiljnih gljivičnih infekcija.
English: Apache II score ≤ 20 Apache II score  20
Croatian: Apache II rezultat ≤ 20 Apache II rezultat > 20
English: ECALTA should not be given to patients under 18 years of age.
Croatian: ECALTA se ne smije primjenjivati bolesnicima mlađim od 18 godina.
English: ECALTA will always be prepared and given to you by a doctor or a healthcare professional (there is more information about the method of preparation at the end of the leaflet in the section for medical and healthcare professionals only).
Croatian: Lijek ECALTA će Vam uvijek pripremiti i primijeniti liječnik ili zdravstveni radnik (više informacija o načinu pripreme nalazi se na kraju ove upute u dijelu namijenjenom samo liječnicima i zdravstvenim radnicima).
English: Twenty one (16.3%) had concomitant candidemia.
Croatian: Dvadeset i jedan (16,3%) bolesnika imalo je istovremenu kandidemiju.
English: The safety and efficacy of ECALTA in children and adolescents below 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka ECALTA u djece i adolescenata u dobi ispod 18 godina nisu još ustanovljene.
English: The clinical relevance of this is unknown.
Croatian: Klinička važnost tog nalaza nije poznata.
English: ECALTA is not recommended during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
Croatian: Ne preporučuje se koristiti lijek ECALTA tijekom trudnoće osim ako korist za majku jasno nadmašuje potencijalni rizik za fetus.
English: A total of 129 patients were included in the analysis.
Croatian: U analizu je bilo uključeno ukupno 129 bolesnika.
English: If you receive more ECALTA than you should
Croatian: Ako primite više lijeka ECALTA nego što ste trebali
English: Some of these side effects will be noted by your doctor while monitoring your response and condition.
Croatian: Neke od ovih nuspojava zabilježit će Vaš liječnik za vrijeme praćenja Vašeg odgovora i stanja.
English: What ECALTA is and what it is used for
Croatian: Što je ECALTA i za što se koristi
English: Therapy may be initiated before culture results are known and can be adjusted accordingly once they are available.
Croatian: Terapija se može započeti prije nego što se dobiju rezultati kulture i može se prilagoditi prema rezultatima kad postanu dostupni.
English: Most clinical cases involve caspofungin treatment.
Croatian: Većina kliničkih slučajeva uključuje liječenje kaspofunginom.
English: A total of 46 patients were included in the analysis.
Croatian: U analizu je bilo uključeno ukupno 46 bolesnika.
English: In general, your treatment should continue for at least 14 days after the last day Candida was found in your blood.
Croatian: Općenito, liječenje treba trajati najmanje 14 dana nakon posljednjeg dana kada je Candida nađena u Vašoj krvi.
English: Patients were followed for six weeks beyond the end of all therapy.
Croatian: Bolesnici su bili praćeni šest tjedana nakon završetka svih terapija.
English: Therefore ECALTA is not recommended during pregnancy.
Croatian: Stoga se ECALTA ne preporučuje tijekom trudnoće.
English: Activity in vitro
Croatian: In vitro aktivnost
English: ECALTA prevents normal development of fungal cell walls.
Croatian: ECALTA sprječava normalni razvoj stanične stijenke gljivice.
English: Not known (frequency cannot be estimated from the available data) are:
Croatian: Nuspojave nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka) su:
English: This will take at least 1.5 hours for the maintenance dose and 3 hours for the loading dose.
Croatian: Infuzija će trajati najmanje 1,5 sati za dozu održavanja i 3 sata za udarnu dozu.
English: Duration of treatment In general, antifungal therapy should continue for at least 14 days after the last positive culture.
Croatian: Trajanje terapije Antimikotična terapija općenito treba trajati najmanje 14 dana nakon posljednje pozitivne kulture.
English: Both regimens were welltolerated by these patients.
Croatian: Ovi su bolesnici dobro podnosili oba načina doziranja.
English: Date of first authorisation: 20 September 2007 Date of latest renewal: 28 August 2017
Croatian: Datum posljednje obnove odobrenja: 28. kolovoza 2017.
English: What ECALTA looks like and contents of the pack
Croatian: Kako ECALTA izgleda i sadržaj pakiranja
English: In case of overdose, adverse reactions may occur as mentioned in section 4.8.
Croatian: U slučaju predoziranja mogu nastati nuspojave navedene u dijelu 4.8.
English: A low intersubject variability in systemic exposure (coefficient of variation ~25%) was observed.
Croatian: Opažena je mala interindividualna varijabilnost kod sustavne primjene (koeficijent varijabilnosti ~25%).
English: What ECALTA contains
Croatian: Što ECALTA sadrži
English: There are insufficient data to support the 100 mg dose for longer than 35 days of treatment.
Croatian: Nema dovoljno podataka koji bi poduprli primjenu doze od 100 mg dulje od 35 dana terapije.
English: Isolates with mutations in the hot spot regions of the target gene have been associated with clinical failures or breakthrough infections.
Croatian: Izolati s mutacijama u “hot spot” regijama ciljnog gena povezani su s kliničkim neuspjesima ili probojnim infekcijama.
English: The majority of patients had candidemia only.
Croatian: Većina bolesnika imala je samo kandidemiju.
English: Global Response of Success at EOIVT
Croatian: Opći odgovor uspjeha pri EOIVT
English: There are no special requirements for disposal.
Croatian: Nema posebnih zahtjeva za zbrinjavanje.
English: The majority of patients had candidemia only (84.8%; 39/46).
Croatian: Većina bolesnika imala je samo kandidemiju (84,8%; 39/46).
English: A successful global response was defined as both clinical and microbiologic success EOIVT, End of Intravenous Treatment; EOT, End of All Treatment
Croatian: Uspješni opći odgovor definiran je kao klinički i mikrobiološki uspjeh EOIVT, kraj intravenskog liječenja; EOT, kraj svih liječenja
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Ecalta therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom ECALTA uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: The majority of patients had Apache II scores ≤ 20 and very few were neutropenic.
Croatian: Većina bolesnika imala je APACHE II rezultat 20 i svega ih je nekoliko imalo neutropeniju.
English: The majority of patients had candidemia only (85.7%).
Croatian: Većina bolesnika imala je samo kandidemiju (85,7%).
English: As with any overdose, general supportive measures should be utilised as necessary.
Croatian: Kao i kod predoziranja drugim lijekovima, treba primijeniti mjere općeg potpornog liječenja po potrebi.
English: The mean APACHE II score was 14.9 (range, 2 - 44).
Croatian: Srednja vrijednost APACHE II rezultata iznosila je 14,9 (raspon 2-44).
English: Treatment of invasive candidiasis in adult patients (see sections 4.4 and 5.1).
Croatian: Liječenje invazivne kandidijaze u odraslih bolesnika (vidjeti dio 4.4 i 5.1).
English: Paediatric population Interaction studies have only been performed in adults.
Croatian: Pedijatrijska populacija Ispitivanja interakcija provedena su samo na odraslima.
English: Your doctor may prescribe another medicine following your treatment with ECALTA to continue treating your fungal infection or prevent it from returning.
Croatian: Liječnik Vam može propisati drugi lijek nakon liječenja lijekom ECALTA, kako bi se nastavila terapija gljivične infekcije ili spriječio njezin povratak.
English: Anidulafungin is extensively bound (>99%) to human plasma proteins.
Croatian: Anidulafungin se velikim dijelom (>99%) veže na proteine plazme.
English: Anidulafungin concentrations fell below the lower limits of quantitation 6 days post-dose.
Croatian: Koncentracija anidulafungina smanjila se ispod donje granice kvantifikacije 6 dana nakon primjene lijeka.
English: All-cause mortality by Day 28 was 10/35 (28.6%).
Croatian: Mortalitet zbog svih uzroka do 28. dana iznosio je 10/35 (28,6%).
English: The clearance of anidulafungin is about 1 l/h.
Croatian: Klirens anidulafungina iznosi približno 1 l/h.
English: HIV positivity
Croatian: HIV-pozitivan status
English: Plasma concentrations of anidulafungin in healthy men and women were similar.
Croatian: Koncentracije anidulafungina u plazmi zdravih muškaraca i žena bile su slične.
English: Hypersensitivity to other medicinal products of the echinocandin class.
Croatian: Preosjetljivost na druge lijekove iz klase ehinokandina.
English: Of note, in vitro studies do not fully exclude possible in vivo interactions.
Croatian: Treba napomenuti da in vitro ispitivanja ne isključuju u potpunosti mogućnost interakcija in vivo.
English: Other medicines and ECALTA
Croatian: Drugi lijekovi i ECALTA
English: The table below provides the volumes required for each dose.
Croatian: U sljedećoj tablici prikazani su volumeni potrebni za pojedinu dozu.
English: No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or elderly (see section 5.2).
Croatian: Nije potrebna prilagodba doze u odraslih bolesnika na temelju spola, tjelesne težine, etniciteta, HIVpozitivnog statusa, ili u starijih osoba (vidjeti dio 5.2).
English: This results in inhibition of the formation of 1,3--D-glucan, an essential component of the fungal cell wall.
Croatian: To rezultira inhibicijom stvaranja 1,3-β-D-glukana, neophodnog sastojka staničnog zida gljivica.
English: MIC breakpoint (mg/L) ≤S (Susceptible) >R (Resistant)
Croatian: Granična vrijednost MIK (mg/l) ≤S (osjetljiva) >R (rezistentna)
English: Therefore, no information is available about the penetration of anidulafungin into the cerebrospinal fluid (CSF) and/or across the blood-brain barrier.
Croatian: Zbog toga nema dostupnih podataka o prodiranju anidulafungina u cerebrospinalni likvor i/ili kroz krvno-moždanu barijeru.
English: If these reactions occur, anidulafungin should be discontinued and appropriate treatment administered.
Croatian: Ako se javi takva reakcija, potrebno je prekinuti primjenu anidulafungina i primijeniti odgovarajuću terapiju.
English: Your doctor will determine the duration of your treatment and how much ECALTA you will receive each day and will monitor your response and condition.
Croatian: Vašeg liječenja i koliko ćete lijeka ECALTA primati svakog dana, te će pratiti Vaš odgovor na liječenje i stanje.
English: Administration of anidulafungin to rats did not indicate any effects on reproduction, including male and female fertility.
Croatian: Primjena anidulafungina na štakorima nije pokazala nikakve učinke na reprodukciju, uključujući plodnost mužjaka i ženki.
English: Hypotension, hypertension
Croatian: Hipotenzija, hipertenzija
English: In the presence of ECALTA, fungal cells have incomplete or defective cell walls, making them fragile or unable to grow.
Croatian: Stanice gljivice, u prisutnosti lijeka ECALTA, imaju nepotpunu ili oštećenu staničnu stijenku, zbog čega su krhke i ne mogu rasti.
English: What ECALTA is and what it is used for What you need to know before you use ECALTA How to use ECALTA
Croatian: Što je ECALTA i za što se koristi Što morate znati prije nego počnete primjenjivati lijek ECALTA
English: The treatment starts with 200 mg on the first day (loading dose).
Croatian: Liječenje započinje s 200 mg prvog dana (udarna doza).
English: Treatment with ECALTA should be initiated by a physician experienced in the management of invasive fungal infections.
Croatian: Liječenje lijekom ECALTA treba započeti liječnik s iskustvom u liječenju invazivnih gljivičnih infekcija.
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.
Croatian: Međutim, u eksperimentima na životinjama ove mutacije doprinose križnoj rezistenciji na sva tri ehinokandina i stoga su takvi izolati klasificirani kao rezistentni na ehinokandine sve dok se ne steknu daljnja klinička iskustva u vezi anidulafungina.
English: - The active substance is anidulafungin.
Croatian: - Djelatna tvar je anidulafungin.
English: ECALTA contains the active substance anidulafungin and is prescribed in adults to treat a type of fungal infection of the blood or other internal organs called invasive candidiasis.
Croatian: ECALTA sadrži djelatnu tvar anidulafungin i propisuje se za liječenje jedne vrste gljivične infekcije krvi ili drugih unutarnjih organa poznate pod nazivom invazivna kandidijaza.
English: Convulsion, headache
Croatian: Konvulzije, glavobolja
English: Global success in the MITT population: primary and secondary endpoints Anidulafungin Fluconazole
Croatian: Opći uspjeh liječenja u MITT populaciji: primarni i sekundarni ishodi Anidulafungin Flukonazol
English: If you are concerned that you may have been given too much ECALTA, tell your doctor or another healthcare professional immediately.
Croatian: Ako ste zabrinuti da ste možda dobili previše lijeka ECALTA, odmah o tome obavijestite svog liječnika ili drugog zdravstvenog radnika.
English: The following table includes, the all-causality adverse reactions (MedDRA terms) from 840 subjects receiving 100 mg anidulafungin with frequency corresponding to 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) and from spontaneous reports with frequency not known (cannot be estimated from the available data).
Croatian: Sljedeća tablica prikazuje nuspojave svih uzročnosti (MedDRA pojmovi) u 840 ispitanika koji su primali 100 mg anidulafungina, sa sljedećom učestalosti: 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) te iz spontanih prijava s nepoznatom učestalosti (ne može se procijeniti iz dostupnih podataka).
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.
Croatian: Mortalitet zbog svih uzroka do posjeta u 6. tjednu praćenja za anidulafungin (MITT populacija) iznosio je 4/11 (36,4%) i 2/3 (66,7%) za kaspofungin.
English: In a single-dose clinical study, radiolabeled (
Croatian: U kliničkom ispitivanju s jednokratnom dozom, zdravim je ispitanicima bio primijenjen radioaktivno obilježeni (
English: Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A).
Croatian: Anidulafungin nije klinički važan supstrat, induktor niti inhibitor izoenzima citokroma P450 (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A).
English: Patients who received at least one dose of study medicinal products and who had a positive culture for Candida species from a normally sterile site before study entry were included in the modified intentto-treat (MITT) population.
Croatian: Bolesnici koji su primili najmanje jednu dozu ispitivanog lijeka i koji su prije uključivanja u ispitivanje imali pozitivnu kulturu na vrste Candida iz uobičajeno sterilnih mjesta, uključeni su u modificiranu analizu populacije koja se planirala liječiti (engl. modified intention-to-treat, MITT).
English: The in vitro degradation half-life of anidulafungin under physiologic conditions is approximately 24 hours.
Croatian: In vitro poluvijek razgradnje anidulafungina u fiziološkim uvjetima iznosi približno 24 sata.
English: In multiple-dose patient studies, drug clearance was slightly faster (approximately 22%) in men.
Croatian: U ispitivanjima višekratnih doza u bolesnika, klirens lijeka je bio nešto brži kod muškaraca (približno 22%).
English: For instructions on reconstitution of the medicinal product before administration (see section 6.6).
Croatian: Za upute o rekonstituciji lijeka prije primjene (vidjeti dio 6.6).
English: Anidulafungin has a predominant elimination half-life of approximately 24 hours that characterizes the majority of the plasma concentration-time profile, and a terminal half-life of 40-50 hours that characterises the terminal elimination phase of the profile.
Croatian: Anidulafungin pretežno ima poluvijek eliminacije od približno 24 sata koji obilježava najveći dio profila koncentracije lijeka u plazmi tijekom vremena, a terminalni poluvijek od 40 do 50 sati, koji obilježava profil u dijelu završne faze eliminacije.
English: This will be followed by a daily dose of 100 mg (maintenance dose).
Croatian: Nakon toga slijedi dnevna doza od 100 mg (doza održavanja).
English: If your original symptoms come back, tell your doctor or another healthcare professional immediately.
Croatian: Ako Vam se vrate prvobitni simptomi, odmah o tome obavijestite svog liječnika ili drugog zdravstvenog radnika.
English: Anidulafungin crossed the placental barrier in rats and was detected in foetal plasma.
Croatian: Anidulafungin kod štakora prelazi placentarnu barijeru i pronađen je u fetalnoj plazmi.
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.
Croatian: Farmakokinetika anidulafungina nakon najmanje 5 dnevnih doza ispitana je u 24 imunokompromitirana pedijatrijska bolesnika (u dobi od 2 do 11 godina) i adolescenata (u dobi od 12 do 17 godina) s neutropenijom.
English: ECALTA belongs to a group of medicines called echinocandins.
Croatian: ECALTA pripada skupini lijekova pod nazivom ehinokandini.
English: Anaphylactic reactions, including shock, were reported with the use of anidulafungin.
Croatian: Anafilaktičke reakcije, uključujući šok, zabilježene su s primjenom anidulafungina.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of anidulafungin in milk.
Croatian: Dostupni farmakodinamički/toksikološki podaci u životinja pokazuju da se anidulafungin izlučuje u mlijeko.
English: Ethnicity Anidulafungin pharmacokinetics were similar among Caucasians, Blacks, Asians, and Hispanics.
Croatian: Rasa Farmakokinetika anidulafungina bila je slična kod bijelaca, crnaca, azijata i latinoamerikanaca.
English: Approximately 30% of the administered radioactive dose was eliminated in the faeces over 9 days, of which less than 10% was intact drug.
Croatian: Približno 30% radioaktivne doze eliminirano je stolicom u razdoblju od 9 dana, od čega manje od 10% lijeka u nepromijenjenom obliku.
English: Activity in vivo
Croatian: Aktivnost in vivo
English: The efficacy of ECALTA has only been evaluated in a limited number of neutropenic patients (see section 5.1).
Croatian: Djelotvornost lijeka Ecalta procijenjena je samo u ograničenog broja bolesnika s neutropenijom (vidjeti dio 5.1).
English: A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.
Croatian: Jednokratnu udarnu dozu od 200 mg treba primijeniti 1. dana, a nakon toga 100 mg dnevno.
English: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium
Croatian: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgija
English: Anidulafungin displays linear pharmacokinetics across a wide range of once daily doses (15-130 mg).
Croatian: Anidulafungin pokazuje linearnu farmakokinetiku unutar širokog raspona jednokratnih dnevnih doza (15-130 mg).
English: The reconstitution time can be up to 5 minutes.
Croatian: Rekonstitucija može trajati do 5 minuta.
English: The reconstituted solution contains 3.33 mg/mL anidulafungin and the diluted solution contains 0.77 mg/mL anidulafungin.
Croatian: Rekonstituirana otopina sadrži 3,33 mg/ml anidulafungina, a razrijeđena otopina sadrži 0,77 mg/ml anidulafungina.
English: Anidulafungin exhibited in-vitro activity against C. albicans, C. glabrata, C. parapsilosis, C. krusei and C. tropicalis.
Croatian: Anidulafungin je iskazao aktivnost in-vitro protiv C. albicans, C. glabrata, C. parapsilosis, C. krusei i C. tropicalis.
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.
Croatian: Stopa uspješnog općeg odgovora na kraju intravenskog liječenja (primarna mjera ishoda) te na kraju svih liječenja i mortalitet zbog svih uzroka do posjeta u 6. tjednu praćenja prikazan je u Tablici 5.
English: Additional Data in Patients with Deep Tissue Infections
Croatian: Dodatni podaci u bolesnika s infekcijama dubokog tkiva
English: Life-threatening allergic reactions that might include difficulty breathing with wheezing or worsening of an existing rash have been rarely reported during administration of ECALTA.
Croatian: Po život opasne alergijske reakcije koje mogu uključivati poteškoće disanja s piskanjem ili pogoršanje postojećeg osipa bile su rijetko zabilježene za vrijeme primjene lijeka ECALTA.
English: - Life-threatening allergic reactions
Croatian: - po život opasne alergijske reakcije
English: Excipient with known effect: Fructose 102.5 mg per vial
Croatian: Pomoćna tvar s poznatim učinkom: fruktoza 102,5 mg po bočici
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se svom liječniku prije nego počnete uzimati ovaj lijek.
English: No clinical adverse reactions were reported.
Croatian: Nisu bile zabilježene nikakve kliničke nuspojave.
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).
Croatian: U primarnoj analizi djelotvornosti, opći odgovor u MITT populaciji na kraju intravenske terapije, anidulafungin je bio uspoređen s flukonazolom pomoću prethodno specificirane statističke usporedbe u dva stupnja (utvrđivanje neinferiornosti nakon koje je slijedilo utvrđivanje superiornosti).
English: ECALTA must not be administered as a bolus injection.
Croatian: ECALTA se ne smije primijeniti u obliku bolus injekcije.
English: Candida Species
Croatian: Vrsta iz roda Candida
English: If you forgot to use ECALTA
Croatian: Ako ste zaboravili uzeti lijek ECALTA
English: Rate of Successful Global Response a and All-Cause Mortality in Patients with Deep Tissue Candidiasis - Pooled Analysis MITT Population n/N (%)
Croatian: Tablica 5. Stopa uspješnog općeg odgovora a i smrtnost zbog svih uzroka kod bolesnika s kandidijazom dubokog tkiva - udružena analiza MITT populacija n/N (%)