natgillin/translations-raw huggingface dataset:
[Very common (≥ 1/ 10), Common (≥ 1/ 100, < 1/ 10)]
[Zelo pogosto (≥1/ 10), pogosto (≥1/ 100, < 1/ 10)]
Common: anaemia
Pogosto: anemija
Common: headache
Pogosto: glavobol
Common: tachycardia
Pogosto: tahikardija
Common: phlebitis/ thrombophlebitis, flushing
Pogosto: flebitis/ tromboflebitis, rdečica
Common: dyspnoea
Pogosto: dispneja
Common: abdominal pain, nausea, diarrhoea, vomiting
Pogosto: bolečine v trebuhu, navzeja, driska, bruhanje
Common: rash, pruritus, sweating
Pogosto: izpuščaj, srbenje, potenje
Very common: fever Common: pain, chills, infused-vein complications
Zelo pogosto: zvišana telesna temperatura Pogosto: bolečine, mrzlica, zapleti na veni, uporabljeni za infundiranje
Common: elevated liver values (AST, ALT, alkaline phosphatase, direct and total bilirubin), increased serum creatinine, decreased haemoglobin, decreased haematocrit, blood potassium decreased, hypomagnesaemia, low albumin, decreased white blood cells, increased eosinophils, platelet count decreased, decreased neutrophils, increased urinary red blood cells, increased partial thromboplastin time, decreased total serum protein, increased urinary protein, increased prothrombin time, blood sodium decreased, increased urinary white blood cells and low calcium.
Pogosto: zvišanje vrednosti jetrnih encimov (AST, ALT, alkalne fosfataze; direktnega in celokupnega bilirubina), zvišanje kreatinina v serumu, znižanje hemoglobina, znižanje hematokrita, znižanje kalija v krvi, hipomagneziemija, nizka raven albumina, zmanjšano število levkocitov, povečano število eozinofilcev, zmanjšano število trombocitov, zmanjšano število nevtrofilcev, povečano število eritrocitov v urinu, podaljšan delni tromboplastinski čas, zmanjšana raven celokupnih beljakovin v serumu, povečana raven beljakovin v urinu, podaljšan protrombinski čas, nizka koncentracija natrija v krvi, povečano število levkocitov v urinu in nizka koncentracija kalcija.
High calcium has been reported as uncommon (≥ 1/ 1000, < 1/ 100).
O visoki koncentraciji kalcija so poročali redko (≥1/ 1000, < 1/ 100).
Possible histamine-mediated symptoms have been reported including reports of rash, facial swelling, pruritus, sensation of warmth, or bronchospasm.
Poročali so o simptomih, pri katerih bi posrednik lahko bil histamin, vključno s primeri izpuščaja, otekanja obraza, srbenja, občutka toplote ali bronhospazma.
Anaphylaxis has been reported during administration of CANCIDAS.
Med jemanjem zdravila CANCIDAS so poročali tudi o anafilaksiji.
Also reported in patients with invasive aspergillosis were pulmonary oedema, adult respiratory distress syndrome (ARDS), and radiographic infiltrates.
Pri bolnikih z invazivno aspergilozo so opisani tudi pljučni edem, sindrom dihalne stiske odraslih (ARDS) in rentgensko vidni infiltrati.
Paediatric Patients In clinical studies, 171 paediatric patients received single or multiple doses of CANCIDAS:
6 Pediatrični bolniki V kliničnih raziskavah je posamične ali večkratne odmerke zdravila CANCIDAS dobilo 171 pediatričnih bolnikov:
104 febrile, neutropenic patients; 56 patients with invasive candidiasis; 1 patient with esophageal candidiasis; and 10 patients with invasive aspergillosis.
104 febrilni nevtropenični bolniki, 56 bolnikov z invazivno kandidiazo, 1 bolnik z ezofagealno kandidiazo in 10 bolnikov z invazivno aspergilozo.
The overall safety profile of CANCIDAS in paediatric patients is generally comparable to that in adult patients.
V celoti je varnostni profil zdravila CANCIDAS pri pediatričnih bolnikih primerljiv s tistim pri odraslih.
6 [Very common (≥ 1/ 10), Common (≥ 1/ 100, < 1/ 10)]
[Zelo pogosti (≥1/ 10), pogosti (≥1/ 100, < 1/ 10)]
Common:
Bolezni jeter, žolčnika in žolčevodov:
Elevated liver enzyme levels (AST, ALT)
Pogosti: zvišanje jetrnih encimov (AST, ALT)
Common: rash, pruritus
Pogosti: izpuščaj, srbenje
Very Common: fever Common: chills, catheter site pain
Zelo pogosti: zvišana telesna temperatura Pogosti: mrzlica, bolečina na mestu katetra
Common: decreased potassium, hypomagnesemia, increased glucose, decreased phosphorus, increased phosphorus, and increased eosinophils.
Pogosti: znižan kalij, hipomagneziemija, zvišana glukoza, znižan fosfat, zvišan fosfat in povečano število eozinofilcev.
As in adult patients, similar histamine-mediated symptoms have also been reported in paediatric patients.
Tudi pri pediatričnih bolnikih so bili opisani podobni histaminsko posredovani simptomi kot pri odraslih.
Post-Marketing experience:
Izkušnje z zdravilom na tržišču:
The following post-marketing adverse events have been reported:
V obdobju trženja so poročali o naslednjih neželenih učinkih:
Hepatic dysfunction
Bolezni jeter, žolčnika in žolčevodov: motnje v delovanju jeter
Swelling and peripheral oedema
Splošne težave in spremembe na mestu aplikacije: oteklina in periferni edemi
Hypercalcaemia
Preiskave: hiperkalciemija
Inadvertent administration of up to 140 mg of caspofungin in one day has been reported.
Opisana je bila naključna uporaba do 140 mg kaspofungina v enem dnevu.
These occurrences did not result in clinically important adverse experiences.
Ti dogodki niso povzročili klinično pomembnih neželenih pojavov.
Pharmacotherapeutic group: antimycotics for systemic use, ATC Code:
Farmakoterapevtska skupina: antimikotiki za sistemsko zdravljenje, Oznaka ATC:
Caspofungin acetate is a semi-synthetic lipopeptide (echinocandin) compound synthesised from a fermentation product of Glarea lozoyensis.
Kaspofunginijev acetat je polsintetična lipopeptidna (ehinokandin) spojina, sintetizirana iz fermentacijskega produkta Glarea- e lozoyensis.
Caspofungin acetate inhibits the synthesis of beta (1,3)-D-glucan, an essential component of the cell wall of many filamentous fungi and yeast.
Kaspofunginijev acetat zavira sintezo beta (1, 3) - D - glukana, ki je bistvena sestavina celične stene številnih filamentoznih gliv in kvasovk.
Beta (1,3)-D-glucan is not present in mammalian cells.
Beta (1, 3) - D - glukan ni prisoten v celicah sesalcev.
7 Fungicidal activity with caspofungin has been demonstrated against Candida yeasts.
Fungicidno delovanje kaspofungina je bilo dokazano proti kvasovkam vrste Candida.
Studies in vitro and in vivo demonstrate that exposure of Aspergillus to caspofungin results in lysis and death of hyphal apical tips and branch points where cell growth and division occur.
Raziskave in vitro in in vivo so pokazale, da pri izpostavitvi glive Aspergillus kaspofunginu pride do lize in odmrtja apikalnih vršičkov in mest vejanja hif, kjer se odvijata celična rast in delitev.
Caspofungin has in vitro activity against Aspergillus species (Aspergillus fumigatus [N = 75], Aspergillus flavus [N = 111], Aspergillus niger [N = 31], Aspergillus nidulans [N = 8], Aspergillus terreus [N = 52], and Aspergillus candidus [N = 3]).
(Aspergillus fumigatus [N = 75], Aspergillus flavus [N = 111], Aspergillus niger [N = 31], Aspergillus nidulans [N = 8], Aspergillus terreus [N = 52] in Aspergillus candidus [N = 3]).
Caspofungin also has in vitro activity against Candida species (Candida albicans [N = 1032], Candida dubliniensis [N = 100], Candida glabrata [N = 151], Candida guilliermondii [N = 67], Candida kefyr [N = 62], Candida krusei [N = 147], Candida lipolytica [N = 20], Candida lusitaniae [N = 80], Candida parapsilosis [N = 215], Candida rugosa [N = 1], and Candida tropicalis [N = 258]), including isolates with multiple resistance transport mutations and those with acquired or intrinsic resistance to fluconazole, amphotericin B, and 5-flucytosine.
(Candida albicans [N = 1032], Candida dubliniensis [N = 100], Candida glabrata [N = 151], Candida guilliermondii [N = 67], Candida kefyr [N = 62], Candida krusei [N = 147], Candida lipolytica [N = 20], Candida lusitaniae [N = 80], Candida parapsilosis [N = 215], Candida rugosa [N = 1] in Candida tropicalis [N = 258], vključno z izolati s prenosnimi mutacijami, ki so odgovorne za rezistenco na številne antibiotike, in tistimi s pridobljeno ali intrinzično rezistenco na flukonazol, amfotericin B in 5- flucitozin.
Susceptibility testing was performed according to a modification of both the Clinical and Laboratory Standards Institute (CLSI, formerly known as the National Committee for Clinical Laboratory Standards [NCCLS]) method M38-A (for Aspergillus species) and method M27-A (for Candida species).
Testiranje občutljivosti je bilo izvedeno po modifikaciji metode M38- A (za Aspergillus sp.) kot tudi metode M27- A (za Candida sp.) Inštituta za klinične in laboratorijske standarde (CLSI, prej znanega pod imenom Nacionalni odbor za klinične laboratorijske standarde [National Committee for Clinical Laboratory Standard – NCCLS]).
Mutants of Candida with reduced susceptibility to caspofungin have been identified in some patients during treatment.
Pri nekaterih bolnikih so bili med zdravljenjem odkriti sevi Candide z zmanjšano občutljivostjo za kaspofungin.
However, standardised techniques for susceptibility testing for antifungal agents, including beta (1,3)-D-glucan synthesis inhibitors, have not been established.
Vendar pa standardizirane tehnike za preizkušanje občutljivosti za protiglivična zdravila, vključno z zaviralci sinteze beta (1, 3) - D- glukana, še niso določene.
MIC values for caspofungin should not be used to predict clinical outcome, since a correlation between MIC values and clinical outcome has not been established.
MIC vrednosti za kaspofungin se ne smejo uporabljati za napovedovanje kliničnega izida, ker korelacija med MIC vrednostmi in kliničnim izidom ni bila dokazana.
Development of in vitro resistance to caspofungin by Aspergillus species has not been identified.
Razvoja rezistence na kaspofungin pri Aspergillus sp. in vitro niso ugotovili.
In limited clinical experience, resistance to caspofungin in patients with invasive aspergillosis has not been observed.
V omejenih kliničnih izkušnjah odpornosti na kaspofungin pri bolnikih s kandidiazo in invazivno aspergilozo niso opazili.
The incidence of resistance to caspofungin by various clinical isolates of Candida and Aspergillus is unknown.
Pojavnost rezistence na kaspofungin pri različnih kliničnih izolatih vrste Candida in Aspergillus ni znana.
Invasive Candidiasis in Adult Patients:
Invazivna kandidiaza pri odraslih bolnikih:
Two hundred thirty-nine patients were enrolled in a study to compare caspofungin and amphotericin B for the treatment of invasive candidiasis.
V raziskavo, ki je primerjala kaspofungin in amfotericin B pri zdravljenju invazivne kandidiaze, je bilo vključenih 239 bolnikov.
Twenty-four patients had neutropaenia.
24 bolnikov je imelo nevtropenijo.
The most frequent diagnoses were bloodstream infections (candidaemia) (77%, n=186) and Candida peritonitis (8%, n=19); patients with Candida endocarditis, osteomyelitis, or meningitis were excluded from this study.
Najpogostejši diagnozi sta bili okužba krvi (kandidemija) (77%, n = 186) in kandidiazni peritonitis (8%, n = 19); bolniki s kandidiaznim endokarditisom, osteomielitisom ali meningitisom so bili iz raziskave izključeni.
Caspofungin 50 mg once daily was administered following a 70 mg loading dose, while amphotericin B was administered at 0.6 to 0.7 mg/ kg/ day to non-neutropaenic patients or 0.7 to 1.0 mg/ kg/ day to neutropaenic patients.
Amfotericin B so pri nenevtropeničnih bolnikih uporabljali v odmerku 0, 6 do 0, 7 mg/ kg/ dan, pri nevtropeničnih pa v odmerku 0, 7 do 1, 0 mg/ kg/ dan.
The mean duration of intravenous therapy was 11.9 days, with a range of 1 to 28 days.
Intravensko zdravljenje je v povprečju trajalo 11, 9 dneva z razponom od 1 do 28 dni.
Two hundred twenty-four patients were included in the primary efficacy analysis (MITT analysis) of response at the end of IV study therapy; favourable response rates for the treatment of invasive candidiasis were comparable for caspofungin (73% [80/ 109]) and amphotericin B (62% [71/ 115]) [% difference 12.7 (95.6% CI -0.7, 26.0)].
V analizo primarne učinkovitosti (analiza MITT; MITT – “ modified intention- to- treat ”) odziva na koncu intravenskega raziskovanega zdravljenja je bilo vključenih 224 bolnikov; delež ugodnega odziva pri zdravljenju invazivne kandidiaze s kaspofunginom (73% [80/ 109]) in amfotericinom B (62% [71/ 115]) je bil podoben [% razlike 12, 7 (95, 6% CI - 0, 7, 26, 0)].
Among patients with candidaemia, favourable response rates at the end of IV study therapy were comparable for caspofungin (72% [66/ 92]) and amphotericin B (63% [59/ 94]) in the primary efficacy analysis (MITT analysis) [% difference 10.0 (95.0% CI -4.5, 24.5)].
Med bolniki s kandidemijo sta bila deleža ugodnega odziva na koncu intravenskega raziskovanega zdravljenja v analizi primarne učinkovitosti (analiza MITT) pri kaspofunginu (72% [66/ 92]) in amfotericinu B (63% [59/ 94]) podobna [% razlike 10, 0 (95, 0% CI - 4, 5, 24, 5)].
Data in patients with non-blood sites of infection were more limited.
Podatkov o bolnikih z nekrvnimi mesti okužbe je manj.
Favourable response rates in neutropaenic patients were 7/ 14 (50%) in the caspofungin group and 4/ 10 (40%) in the amphotericin B group.
Delež ugodnega odziva pri nevtropeničnih bolnikih je bil med prejemniki zdravila CANCIDAS 7/ 14 (50%) in med prejemniki amfotericina B 4/ 10 (40%).
These limited data are supported by the outcome of the empirical therapy study.
Ti omejeni podatki so podprti z rezultati raziskave empiričnega zdravljenja.
Invasive Aspergillosis in Adult Patients:
8 Invazivna aspergiloza pri odraslih bolnikih:
Sixty-nine adult patients (age 18-80) with invasive aspergillosis were enrolled in an open-label, non-comparative study to evaluate the safety, tolerability, and efficacy of caspofungin.
69 odraslih bolnikov (starih 18- 80 let) z invazivno aspergilozo je sodelovalo v odprti, neprimerjalni raziskavi za oceno varnosti, prenašanja in učinkovitosti kaspofungina.
Patients had to be either refractory to (disease progression or failure to improve with other antifungal therapies given for at least 7 days) (84% of the enrolled patients) or intolerant of (16% of enrolled patients) other standard antifungal therapies.
Bolniki so morali biti nedovzetni za druga standardna protiglivična zdravila (napredovanje bolezni ali nespremenjeno stanje ob vsaj 7 dnevnem prejemanju drugih protiglivičnih zdravil) (84% vključenih bolnikov) ali jih niso smeli prenašati (16% vključenih bolnikov).
Most patients had underlying conditions (haematologic malignancy [N = 24], allogeneic bone marrow transplant or stem cell transplant [N = 18], organ transplant [N = 8], solid tumour [N = 3], or other conditions [N = 10]).
Večina bolnikov je imela neko osnovno bolezen/ stanje (maligno hematološko bolezen [N = 24], stanje po alogenski presaditvi kostnega mozga ali matičnih celic [N = 18], stanje po presaditvi organa [N = 8], solidni tumor [N = 3] ali drugo bolezen/ stanje [N = 10]).
The mean duration of therapy was 33.7 days, with a range of 1 to 162 days.
Srednje trajanje zdravljenja je bilo 33, 7 dni, z razponom od 1 do 162 dni.
An independent expert panel determined that 41% (26/ 63) of patients receiving at least one dose of caspofungin had a favourable response.
Neodvisni strokovni odbor je ugotovil, da je do ugodnega odziva prišlo pri 41% (26/ 63) bolnikih, ki so dobili vsaj en odmerek kaspofungina.
For those patients who received more than 7 days of therapy with caspofungin, 50% (26/ 52) had a favourable response.
Med bolniki, ki so se s kaspofunginom zdravili več kot 7 dni, se jih je na zdravljenje ugodno odzvalo 50% (26/ 52).
The favourable response rates for patients who were either refractory to or intolerant of previous therapies
Delež ugodnega odziva je pri bolnikih, ki se na prejšnje zdravljenje niso odzvali, znašal 36% (19/ 53), med bolniki, ki prejšnjega zdravljenja niso prenašali, pa 70% (7/ 10).
Although the doses of prior antifungal therapies in 5 patients enrolled as refractory were lower than those often administered for invasive aspergillosis, the favourable response rate during therapy with caspofungin was similar in these patients to that seen in the remaining refractory patients (2/ 5 versus 17/ 48, respectively).
Čeprav so bili pri 5 bolnikih, ki so bili v raziskavo vključeni kot nedovzetni, odmerki prejšnjih protiglivičnih zdravil manjši, kot se običajno uporabljajo pri invazivni aspergilozi, je bil delež ugodnega odziva na zdravljenje s kaspofunginom pri njih (2/ 5) podoben deležu pri ostalih neodzivnih bolnikih (17/ 48).
The response rates among patients with pulmonary disease and extrapulmonary disease were 47% (21/ 45) and 28% (5/ 18), respectively.
Delež odziva na zdravljenje je pri bolnikih s pljučno boleznijo znašal 47% (21/ 45), pri bolnikih z zunaj- pljučno boleznijo pa 28% (5/ 18).
Among patients with extrapulmonary disease, 2 of 8 patients who also had definite, probable, or possible CNS involvement had a favourable response.
Med bolniki z zunaj- pljučno boleznijo sta se na zdravljenje ugodno odzvala 2 bolnika od 8 z gotovo, verjetno ali možno okužbo osrednjega živčevja.
Empirical Therapy in Febrile, Neutropaenic Adult Patients:
Empirično zdravljenje febrilnih, nevtropeničnih odraslih bolnikov:
A total of 1111 patients with persistent fever and neutropaenia were enrolled in a clinical study and treated with either caspofungin 50 mg once daily following a 70 mg loading dose or liposomal amphotericin B 3.0 mg/ kg/ day.
Bolniki so dobivali bodisi kaspofungin 50 mg enkrat na dan (po 70- mg uvajalnem odmerku) ali liposomski amfotericin B 3, 0 mg/ kg/ dan.
Eligible patients had received chemotherapy for malignancy or had undergone hematopoietic stem-cell transplantation, and presented with neutropaenia (< 500 cells/mm3 for 96 hours) and fever (> 38.0°C) not responding to ≥ 96 hours of parenteral antibacterial therapy.
Za raziskavo ustrezni bolniki so dobivali kemoterapijo zaradi malignoma ali so prestali presaditev hematopoetskih matičnih celic ter so imeli nevtropenijo (< 500 celic/ mm3 96 ur) in zvišano telesno temperaturo (> 38. 0 °C), brez odziva na ≥ 96- urno parenteralno protibakterijsko terapijo.
Patients were to be treated until up to 72 hours after resolution of neutropaenia, with a maximum duration of 28 days.
Določeni čas zdravljenja je bil do 72 ur po koncu nevtropenije in največ 28 dni; zdravljenje bolnikov s potrjeno glivično okužbo je lahko trajalo dlje.
However, patients found to have a documented fungal infection could be treated longer.
Če je bolnik zdravilo dobro prenašal, a je imel po 5 dneh zdravljenja še vedno zvišano telesno temperaturo, klinično stanje pa se je slabšalo, je bilo mogoče odmerek raziskovanega zdravila zvečati na 70 mg kaspofungina/ dan (13, 3% zdravljenih bolnikov) oz. na 5, 0 mg liposomskega amfotericina B/ kg/ dan (14, 3% zdravljenih bolnikov).
If the drug was well tolerated but the patient’ s fever persisted and clinical condition deteriorated after 5 days of therapy, the dosage of study drug could be increased to 70 mg/ day of caspofungin (13.3% of patients treated) or to 5.0 mg/ kg/ day of liposomal amphotericin B (14.3% of patients treated).
V primarno analizo učinkovitosti MITT celotnega ugodnega odziva je bilo vključenih 1. 095 bolnikov.
There were 1095 patients included in the primary Modified Intention-To-Treat (MITT) efficacy analysis of overall favourable response; caspofungin (33.9%) was as effective as liposomal amphotericin B (33.7%) [% difference 0.2 (95.2% CI – 5.6, 6.0)].
Kaspofungin (33, 9%) je bil enako učinkovit kot liposomski amfotericin B (33, 7%) [% razlike 0, 2 (95, 2% CI – 5, 6, 6, 0)].
An overall favourable response required meeting each of 5 criteria:
Celotni odziv je bil ocenjen kot ugoden, če je bilo izpolnjenih vseh 5 naslednjih meril:
(1) successful treatment of any baseline fungal infection (caspofungin 51.9% [14/ 27], liposomal amphotericin B 25.9% [7/ 27]), (2) no breakthrough fungal infections during administration of study drug or within 7 days after completion of treatment (caspofungin 94.8% [527/ 556], liposomal amphotericin B 95.5% [515/ 539]), (3) survival for 7 days after completion of study therapy (caspofungin 92.6% [515/ 556], liposomal amphotericin B 89.2% [481/ 539]), (4) no discontinuation from the study drug because of drug-related toxicity or lack of efficacy (caspofungin 89.7% [499/ 556], liposomal amphotericin B 85.5% [461/ 539]), and (5) resolution of fever during the period of neutropaenia (caspofungin 41.2% [229/ 556], liposomal amphotericin B 41.4% [223/ 539]).
(1) uspešno zdravljenje morebitne osnovne glivične okužbe (kaspofungin 51, 9% [14/ 27], liposomski amfotericin B 25, 9% [7/ 27]), (2) brez izbruha glivičnih okužb med uporabo raziskovanega zdravila in 7 dni po njenem zaključku (kaspofungin 94, 8% [527/ 556], liposomski amfotericin B 95, 5% [515/ 539]), (3) preživetje 7 dni po zaključku raziskovane terapije (kaspofungin 92, 6% [515/ 556], liposomski amfotericin B 89, 2% [481/ 539]), (4) brez prekinitve raziskovanega zdravila zaradi njegove toksičnosti ali nezadostne učinkovitosti (kaspofungin 89, 7% [499/ 556], liposomski amfotericin B 85, 5% [461/ 539]), (5) izginotje zvišane telesne temperature med obdobjem nevtropenije (kaspofungin 41, 2% [229/ 554], liposomski amfotericin B 41, 4% [223/ 539]).
Response rates to caspofungin and liposomal amphotericin B for baseline infections caused by Aspergillus species were, respectively, 41.7% (5/ 12) and 8.3% (1/ 12), and by Candida species were 66.7% (8/ 12) and 41.7% (5/ 12).
Pri osnovnih okužbah z vrsto Aspergillus je bil delež odziva na kaspofungin 41, 7% (5/ 12) in na liposomski amfotericin B 8, 3% (1/ 12), pri osnovnih okužbah z vrsto Candida pa na kaspofungin 66, 7% (8/ 12) in na liposomski amfotericin B 41, 7% (5/ 12).
Patients in the caspofungin group experienced breakthrough infections due to the following uncommon yeasts and moulds:
Bolniki v kaspofunginski skupini do doživeli izbruh okužb z naslednjimi redkimi vrstami kvasovk in plesni:
Trichosporon species (1), Fusarium species (1), Mucor species (1), and Rhizopus species (1).
Trichosporon (1), Fusarium (1), Mucor (1) in Rhizopus (1).
Paediatric Patients The safety and efficacy of CANCIDAS was evaluated in paediatric patients 3 months to 17 years of age in two prospective, multicenter clinical trials.
Pediatrični bolniki Varnost in učinkovitost zdravila CANCIDAS so pri pediatričnih bolnikih, starih od 3 mesece do 17 let, ocenili v dveh prospektivnih, multicentričnih kliničnih preskušanjih.
The study design, diagnostic criteria, and criteria for efficacy assessment were similar to the corresponding studies in adult patients (see section 5.1).
Načrt raziskave, diagnostična merila in merila za ocenjevanje učinkovitosti so bili podobni kot pri ustreznih raziskavah pri odraslih bolnikih (glejte poglavje 5. 1).
The first study, which enrolled 82 patients between 2 to 17 years of age, was a randomized, double- blind study comparing CANCIDAS (50 mg/ m2 IV once daily following a 70-mg/ m2 loading dose on Day 1 [not to exceed 70 mg daily]) to liposomal amphotericin B (3 mg/ kg IV daily) in a 2:1 treatment fashion (56 on caspofungin, 26 on liposomal amphotericin B) as empirical therapy in paediatric patients with persistent fever and neutropenia.
Primerjala je zdravilo CANCIDAS (50 mg/ m2 intravensko enkrat na dan po uvajalnem odmerku 70 mg/ m2 1. dan [a ne več kot 70 mg na dan]) in liposomski amfotericin B (3 mg/ kg intravensko na dan) v razporedu zdravljenja 2: 1 (56 na kaspofunginu, 26 na liposomskem amfotericinu B) kot empirično zdravljenje pediatričnih bolnikov z dolgotrajno zvišano telesno temperaturo in nevtropenijo.
The overall success rates in the MITT analysis results, adjusted by risk strata, were as follows:
Celotna deleža uspeha po analizi rezultatov MZNZ (modificirane skupine- z- namenom- zdravljenja), prilagojenih glede na stratume tveganja, sta bila:
46.6% (26/ 56) for CANCIDAS and 32.2% (8/ 25) for liposomal amphotericin B.
46, 6% (26/ 56) za zdravilo CANCIDAS in 32, 2% (8/ 25) za liposomski amfotericin B.