natgillin/translations-raw huggingface dataset:
The adverse event profile of these 245 paediatric patients was similar to that in adults.
Profil neželenih učinkov pri teh 245 pediatričnih bolnikih je bil podoben kot pri odraslih.
In the 22 patients less than 2 years old who received voriconazole in a compassionate use programme, the following adverse events (for which a relationship to voriconazole could not be excluded) were reported: photosensitivity reaction (1), arrhythmia (1), pancreatitis (1),
Pri 22 bolnikih, mlajših od dveh let, ki so dobivali vorikonazol v programu sočutne uporabe, so poročali o naslednjih neželenih učinkih (za katere povezava z vorikonzolom ni bila izključena): fotosenzitivnostna kožna reakcija (1), aritmija (1), pankreatitis (1), zvišanje ravni bilirubina v krvi (1), zvišanje ravni jetrnih encimov (1), izpuščaj (1) in edem papile vidnega živca (1).
14 blood bilirubin increased (1), hepatic enzymes increased (1), rash (1) and papilloedema (1).
V pomarketinškem obdobju so pri pediatričnih bolnikih poročali o primerih pankreatitisa.
A single adverse event of photophobia of 10 minutes duration was reported.
Poročali so o enem samem neželenem učinku, in sicer o fotofobiji, ki je trajala 10 minut.
J02A C03 Antimycotics for Systemic Use – Triazole derivatives
J02A C03 Antimikotiki za sistemsko zdravljenje – derivati triazola
Mechanism of action In vitro, voriconazole displays broad-spectrum antifungal activity with antifungal potency against Candida species (including fluconazole resistant C. krusei and resistant strains of C. glabrata and C. albicans) and fungicidal activity against all Aspergillus species tested.
Vorikonazol ima in vitro širok spekter antimikotičnega delovanja z antimikotičnim učinkom proti vrsti Candida (vključno s C. krusei, odporno proti flukonazolu, in odpornimi sevi C. glabrata in C. albicans) ter fungiciden učinek proti vsem testiranim vrstam Aspergillus.
In addition voriconazole shows in vitro fungicidal activity against emerging fungal pathogens, including those such as Scedosporium or Fusarium which have limited susceptibility to existing antifungal agents.
Poleg tega deluje vorikonazol in vitro fungicidno proti pojavljajočim se glivičnim patogenom, vključno s takšnimi, kot sta Scedosporium in Fusarium, ki sta le omejeno občutljiva za obstoječa antimikotična zdravila.
Its mode of action is inhibition of fungal cytochrome P450-mediated 14α -sterol demethylation, an essential step in ergosterol biosynthesis.
Deluje tako, da zavre 14α- sterolsko demetilacijo, ki jo posreduje glivični citokrom P450 in je ključen korak v biosintezi ergosterola.
In animal studies there is a correlation between minimum inhibitory concentration values and efficacy against experimental mycoses.
V študijah na živalih obstaja korelacija med minimalno inhibitorno koncentracijo in učinkovitostjo proti eksperimentalnim mikozam.
By contrast, in clinical studies, there appears to be no correlation between minimum inhibitory concentration values and clinical outcome.
V nasprotju s tem v kliničnih študijah ne kaže, da bi obstajala korelacija med minimalno inhibitorno koncentracijo in kliničnim izidom.
Furthermore, there does not appear to be a correlation between plasma levels and clinical outcome.
Poleg tega tudi ne kaže, da bi obstajala korelacija med koncentracijo v plazmi in kliničnim izidom.
This is typical of azole antimycotics.
To je značilno za azolske antimikotike.
Microbiology Clinical efficacy (with partial or complete response, see below under Clinical Experience) has been demonstrated for Aspergillus spp. including A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans, Candida spp., including C. albicans, C. glabrata, C. krusei, C. parapsilosis and C. tropicalis and limited numbers of C. dubliniensis, C. inconspicua, and C. guilliermondii, Scedosporium spp., including S. apiospermum, S. prolificans and Fusarium spp.
Klinična učinkovitost (z delnim ali popolnim odzivom, glejte "Klinične izkušnje", spodaj) je bila dokazana za Aspergillus spp., vključno z A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans, za Candida spp., vključno s C. albicans, C. glabrata, C. krusei, C. parapsilosis in C. tropicalis in omejenim številom C. dubliniensis, C. inconspicua, in C. guilliermondii, za Scedosporium spp., vključno s S. apiospermum in S. prolificans ter za Fusarium spp.
Other treated fungal infections (with often partial or complete response) included isolated cases of Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp. including P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis and Trichosporon spp. including T. beigelii infections.
Med drugimi zdravljenimi glivičnimi okužbami (pogosto z delnim ali popolnim odzivom) so bili posamezni primeri Alternarie spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp., vključno s P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis ter Trichosporon spp., vključno z okužbami s T. beigelii.
In vitro activity against clinical isolates has been observed for Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp., Histoplasma capsulatum, with most strains being inhibited by concentrations of voriconazole in the range 0.05 to 2µg/ ml.
In vitro so opažali delovanje proti kliničnim izolatom Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp., Histoplasma capsulatum; večino sevov je zavrla koncentracija vorikonazola v območju od 0, 05 do 2 μg/ ml.
15 In vitro activity against the following pathogens has been shown, but the clinical significance is unknown:
In vitro je bilo dokazano delovanje proti naslednjim patogenom, vendar klinični pomen tega ni znan:
Clinical isolates with decreased susceptibility to voriconazole have been identified.
Odkriti so bili klinični izolati z zmanjšano občutljivostjo za vorikonazol.
However, elevated minimum inhibitory concentrations did not always correlate with clinical failure and clinical success has been observed in patients infected with organisms resistant to other azoles.
Vendar zvišana minimalna inhibitorna koncentracija ni vedno korelirala s kliničnim neuspehom in klinični uspeh so opažali pri bolnikih, okuženih z organizmi, odpornimi proti drugim azolom.
Correlation of in vitro activity with clinical outcome is difficult owing to the complexity of the patients studied in clinical trials; breakpoints for voriconazole remain to be established.
Korelacija delovanja in vitro s kliničnim izidom je težavno zaradi zapletenosti primerov, proučevanih v kliničnih preskušanjih; prelomno točko za vorikonazol bo treba še ugotoviti.
Clinical Experience Successful outcome in this section is defined as complete or partial response.
Uspešen izid je v tem delu opredeljen kot popoln ali delen odziv.
Aspergillus infections – efficacy in aspergillosis patients with poor prognosis Voriconazole has in vitro fungicidal activity against Aspergillus spp.
Okužbe z Aspergillusom – učinkovitost pri bolnikih z aspergilozo s slabo prognozo Vorikonazol deluje in vitro fungicidno proti Aspergillus spp.
A satisfactory global response (complete or partial resolution of all attributable symptoms signs, radiographic/ bronchoscopic abnormalities present at baseline) was seen in 53% of voriconazole-treated patients compared to 31% of patients treated with comparator.
Zadovoljiv globalni odziv (popolno ali delno izginotje vseh izhodiščno prisotnih pripisljivih simptomov, znakov, rentgenoloških/ bronhoskopskih nenormalnosti) so ugotovili pri 53% bolnikov, zdravljenih z vorikonazolom, in pri 31% bolnikov, zdravljenih s primerjalnim zdravilom.
The 84-day survival rate for voriconazole was statistically significantly higher than that for the comparator and a clinically and statistically significant benefit was shown in favour of voriconazole for both time to death and time to discontinuation due to toxicity.
Klinično pomembna in statistično značilna prednost vorikonazola se je izkazala tako pri času do smrti, kot pri času do prekinitve zaradi toksičnosti.
This study confirmed findings from an earlier, prospectively designed study where there was a positive outcome in subjects with risk factors for a poor prognosis, including graft versus host disease, and, in particular, cerebral infections (normally associated with almost 100% mortality).
Ta študija je potrdila izsledke zgodnejše, prospektivne študije, v kateri so ugotovili pozitiven izid pri preiskovancih z dejavniki tveganja za slabo prognozo, vključno z boleznijo presadka proti gostitelju in, še posebej, možganskimi okužbami (ki so običajno povezane s skoraj 100- odstotno umrljivostjo).
Candidaemia in non-neutropenic patients The efficacy of voriconazole compared to the regimen of amphotericin B followed by fluconazole in the primary treatment of candidaemia was demonstrated in an open, comparative study.
Učinkovitost vorikonazola v primerjavi s shemo amfotericina B, ki mu je sledil flukonazol (shema amfotericin B/ flukonazol), je v primarnem zdravljenju kandidemije dokazala odprta primerjalna študija.
Nine subjects in the voriconazole group and five in the amphotericin B followed by fluconazole group also had mycologically proven infection in deep tissue.
Devet preiskovancev v skupini z vorikonazolom in pet v skupini z amfotericinom B/ flukonazolom je imelo tudi mikološko dokazano okužbo v globokem tkivu.
In the primary analysis, successful response as assessed by a Data Review Committee (DRC) blinded to study medication was defined as resolution/ improvement in all clinical signs and symptoms of infection with eradication of Candida from blood and infected deep tissue sites at 12 weeks after the end of therapy (EOT).
V primarni analizi je bil uspešen odziv (kot ga je ocenil Odbor za pregled podatkov [OPP], slepljen za proučevano zdravilo) opredeljen kot izginotje/ izboljšanje vseh kliničnih znakov in simptomov okužbe ter odstranitev Candide iz krvi in okuženih mest v globokih tkivih 12 tednov po koncu terapije (KT).
In this analysis a successful response was seen in 41% of patients in both treatment arms.
V tej analizi so uspešen odziv ugotovili pri 41% bolnikov v obeh terapevtskih krakih.
In a secondary analysis, which utilised DRC assessments at the latest evaluable time point (EOT, or 2, 6, or 12 weeks after EOT) voriconazole and the regimen of amphotericin B followed by fluconazole had successful response rates of 65% and 71%, respectively.
V sekundarni analizi, ki je uporabljala oceno OPP na najpoznejši ocenljivi časovni točki (konec terapije ali 2, 6 ali 12 tednov po koncu terapije), je bil delež uspešnega odziva z vorikonazolom 65%, s shemo amfotericin B/ flukonazol pa 71%.
The Investigator’ s assessment of successful outcome at each of these time points is shown in the following table.
Raziskovalčevo oceno uspešnega izida na vsaki od teh časovnih točk prikazuje naslednja preglednica.
16 Timepoint _
časovna točka
EOT 2 weeks after EOT
KT 2 tedna po KT 6 tednov po KT 12 tednov po KT
178 (72%) 125 (50%)
178 (72%) 125 (50%) 104 (42%) 104 (42%)
88 (72%) 62 (51%)
88 (72%) 62 (51%) 55 (45%) 51 (42%)
Serious refractory Candida infections The study comprised 55 patients with serious refractory systemic Candida infections (including candidaemia, disseminated and other invasive candidiasis) where prior antifungal treatment, particularly with fluconazole, had been ineffective.
Hude refraktarne okužbe s Candido Študija je zajela 55 bolnikov s hudimi refraktarnimi sistemskimi okužbami s Candido (vključno s kandidemijo, diseminirano kandidiazo in drugimi invazivnimi oblikami kandidiaze), pri katerih prejšnje antimikotično zdravljenje, zlasti s flukonazolom, ni bilo učinkovito.
In fluconazole-resistant non albicans species, a successful outcome was seen in 3/ 3 C. krusei (complete responses) and 6/ 8 C. glabrata (5 complete, 1 partial response) infections.
16 flukonazolu, so uspešen odziv ugotovili pri 3/ 3 okužbah s C. krusei (popolni odzivi) in 6/ 8 okužbah s C. glabrata (5 popolnih, 1 delen odziv).
Four additional patients with fusariosis had an infection caused by several organisms; two of them had a successful outcome.
Dodatni štirje bolniki s fuzaridiozo so imeli okužbo, povzročeno z več organizmi; dva od njih sta doživela uspešen izid.
Duration of treatment In clinical trials, 561 patients received voriconazole therapy for greater than 12 weeks, with 136 patients receiving voriconazole for over 6 months.
Trajanje zdravljenja V kliničnih preskušanjih je 561 bolnikov dobivalo vorikonazol več kot 12 tednov, 136 pa več kot 6 mesecev.
Experience in paediatric patients Sixty one paediatric patients aged 9 months up to 15 years who had definite or probable invasive fungal infections, were treated with voriconazole.
Izkušnje pri pediatričnih bolnikih Z vorikonazolom je bilo zdravljenih 61 pediatričnih bolnikov, starih od 9 mesecev do 15 let, ki so imeli potrjeno ali verjetno invazivno glivično okužbo.
This population included 34 patients 2 to < 12 years old and 20 patients 12-15 years of age.
Ta populacija je zajela 34 bolnikov, starih od 2 do < 12 let, in 20 bolnikov, starih od 12 do 15 let.
The majority (57/ 61) had failed previous antifungal therapies.
Pri večini (57/ 61) prejšnje antimikotične terapije niso bile uspešne.
Therapeutic studies included 5 patients aged 12-15 years, the remaining patients received voriconazole in the compassionate use programmes.
Terapevtske študije so zajele 5 bolnikov, starih od 12 do 15 let; preostali bolniki so vorikonazol dobili v programih sočutne uporabe.
Underlying diseases in these patients included haematological malignancies and aplastic anaemia (27 patients) and chronic granulomatous disease (14 patients).
Osnovne bolezni pri teh bolnikih so bile hematološki malignomi in aplastična anemija (27 bolnikov) in kronična granulomatozna bolezen (14 bolnikov).
The most commonly treated fungal infection was aspergillosis (43/ 61; 70%).
Najpogosteje zdravljena glivična okužba je bila aspergiloza (43/ 61; 70%).
Clinical Studies Examining QT Interval A placebo-controlled, randomized, single-dose, crossover study to evaluate the effect on the QT interval of healthy volunteers was conducted with three oral doses of voriconazole and ketoconazole.
Klinične študije, ki so preučevale interval Q- T S placebom kontrolirana, randomizirana, navzkrižna študija z enkratnim odmerkom, ki je ocenjevala vpliv treh peroralnih odmerkov vorikonazola in ketokonazola na interval Q- T, je bila izvedena pri zdravih prostovoljcih.
The placebo-adjusted mean maximum increases in QTc from baseline after 800, 1200 and 1600 mg of voriconazole were 5.1, 4.8, and 8.2 msec, respectively and 7.0 msec for ketoconazole 800 mg.
Placebu prirejeno povprečno največje podaljšanje Q- Tc, glede na izhodišče po 800, 1200 in 1600 mg vorikonazola je bilo 5, 1; 4, 8 in 8, 2 milisekunde ter 7, 0 milisekund po 800 mg ketokonazola.
No 17 subject in any group had an increase in QTc of ≥ 60 msec from baseline.
Pri nobenem izmed preiskovancev v vseh skupinah ni prišlo do podaljšanja Q- Tc za ≥ 60 milisekund od izhodišča.
General pharmacokinetic characteristics The pharmacokinetics of voriconazole have been characterised in healthy subjects, special populations and patients.
Splošne farmakokinetične značilnosti Farmakokinetika vorikonazola je bila opredeljena pri zdravih osebah, posebnih populacijah in bolnikih.
During oral administration of 200 mg or 300 mg twice daily for 14 days in patients at risk of aspergillosis (mainly patients with malignant neoplasms of lymphatic or haematopoietic tissue), the observed pharmacokinetic characteristics of rapid and consistent absorption, accumulation and non- linear pharmacokinetics were in agreement with those observed in healthy subjects.
Med 14- dnevno peroralno uporabo 200 mg ali 300 mg dvakrat na dan pri bolnikih, ogroženih z aspergilozo (v glavnem bolnikih z malignimi novotvorbami limfatičnega ali hematopoetskega tkiva), so se opazovane farmakokinetične značilnosti, hitra in konstantna absorpcija, kopičenje in nelinearna farmakokinetika, ujemale s tistimi, opazovanimi pri zdravih osebah.
It is estimated that, on average, increasing the oral dose from 200 mg twice daily to 300 mg twice daily leads to a 2.5-fold increase in exposure (AUCτ).
Ocenjujejo, da povečanje peroralnega odmerka z 200 mg dvakrat na dan na 300 mg dvakrat na dan povzroči v povprečju 2, 5- kratno povečanje izpostavljenosti (AUCτ).
When the recommended intravenous or oral loading dose regimens are administered, plasma concentrations close to steady state are achieved within the first 24 hours of dosing.
17 prvih 24 urah odmerjanja dosežena plazemska koncentracija, ki je blizu stanja dinamičnega ravnovesja.
Without the loading dose, accumulation occurs during twice daily multiple dosing with steady- state plasma voriconazole concentrations being achieved by day 6 in the majority of subjects.
Brez polnilnega odmerka se med večkratnim odmerjanjem dvakrat na dan pojavi kopičenje; pri večini oseb je koncentracija vorikonazola v stanju dinamičnega ravnovesja dosežena do 6. dne.
Absorption Voriconazole is rapidly and almost completely absorbed following oral administration, with maximum plasma concentrations (Cmax) achieved 1-2 hours after dosing.
Absorpcija Vorikonazol se po peroralni uporabi hitro in skoraj popolnoma absorbira in doseže največjo koncentracijo v plazmi (Cmax) 1 do 2 uri po zaužitju.
The absolute bioavailability of voriconazole after oral administration is estimated to be 96%.
Ocenjena absolutna biološka uporabnost vorikonazola po peroralni uporabi je 96%.
When multiple doses of voriconazole are administered with high fat meals, Cmax and AUCτ are reduced by 34% and 24%, respectively.
Če se večkratne odmerke vorikonazola uporablja z zelo mastnimi obroki, se Cmax zmanjša za 34% in AUCτ za 24%.
Distribution The volume of distribution at steady state for voriconazole is estimated to be 4.6 l/ kg, suggesting extensive distribution into tissues.
Porazdelitev Ocenjeni volumen porazdelitve vorikonazola v stanju dinamičnega ravnovesja je 4, 6 l/ kg, kar nakazuje znatno porazdelitev v tkiva.
Plasma protein binding is estimated to be 58%.
Ocenjena vezava na beljakovine v plazmi je 58%.
Metabolism In vitro studies showed that voriconazole is metabolised by the hepatic cytochrome P450 isoenzymes, CYP2C19, CYP2C9 and CYP3A4.
Presnova Študije in vitro so pokazale, da se vorikonazol presnavlja z izoencimi CYP2C19, CYP2C9 in CYP3A4 jetrnega citokroma P450.
For example, 15-20% of Asian populations may be expected to be poor metabolisers.
Tako je na primer mogoče pričakovati, da ima od 15 do 20% azijske populacije zmanjšano presnovo.
For Caucasians and Blacks the prevalence of poor metabolisers is 35%.
Med belci in črnci je prevalenca oseb z zmanjšano presnovo 3– 5%.
Studies conducted in Caucasian and Japanese healthy subjects have shown that poor metabolisers have, on average, 4-fold higher voriconazole exposure (AUCτ) than their homozygous extensive metaboliser counterparts.
Študije pri zdravih belskih in japonskih preiskovancih so pokazale, da je izpostavljenost vorikonazolu (AUCτ) pri osebah z zmanjšano presnovo v povprečju 4- krat večja kot pri primerljivih homozigotnih osebah z izrazito presnovo.
Subjects who are heterozygous extensive metabolisers have on average 2- fold higher voriconazole exposure than their homozygous extensive metaboliser counterparts.
Pri heterozigotnih osebah z izrazito presnovo je izpostavljenost vorikonazolu v povprečju 2- krat večja kot pri homozigotnih osebah z izrazito presnovo.
The major metabolite of voriconazole is the N-oxide, which accounts for 72% of the circulating radiolabelled metabolites in plasma.
Glavni presnovek vorikonazola je N- oksid; na njegov račun gre 72% radioaktivno označenih presnovkov, ki krožijo v plazmi.
Excretion Voriconazole is eliminated via hepatic metabolism with less than 2% of the dose excreted unchanged in the urine.
Izločanje Vorikonazol se izloča z jetrno presnovo; manj kot 2% odmerka se nespremenjenega izloči v urinu.
After administration of a radiolabelled dose of voriconazole, approximately 80% of the radioactivity
Po uporabi radioaktivno označenega odmerka vorikonazola se po večkratnem intravenskem odmerjanju v urinu pojavi približno 80% radioaktivnosti, po večkratnem peroralnem odmerjanju pa 83%.
The majority (> 94%) of the total radioactivity is excreted in the first 96 hours after both oral and intravenous dosing.
Večina (> 94%) celotne radioaktivnosti se tako po peroralni kot po intravenski uporabi izloči v prvih 96 urah.
Pharmacokinetic-Pharmacodynamic relationships In 10 therapeutic studies, the median for the average and maximum plasma concentrations in individual subjects across the studies was 2425 ng/ ml (inter-quartile range 1193 to 4380 ng/ ml) and 3742 ng/ ml (inter-quartile range 2027 to 6302 ng/ ml), respectively.
Farmakokinetično- farmakodinamično razmerje V 10 terapevtskih študijah je bila mediana povprečne koncentracije v plazmi pri posameznih preiskovancih v vseh raziskavah 2425 ng/ ml (interkvartilni obseg od 1193 do 4380 ng/ ml), mediana največje koncentracije v plazmi pa 3742 ng/ ml (interkvartilni obseg od 2027 do 6302 ng/ ml).
A positive association between mean, maximum or minimum plasma voriconazole concentration and efficacy in therapeutic studies was not found.
Pozitivne povezave med povprečno, največjo ali najmanjšo koncentracijo vorikonazola v plazmi ter učinkovitostjo v terapevtskih raziskavah niso ugotovili.
Pharmacokinetic-Pharmacodynamic analyses of clinical trial data identified positive associations between plasma voriconazole concentrations and both liver function test abnormalities and visual disturbances.
18 Farmakokinetično- farmakodinamične analize podatkov kliničnih preskušanj so odkrile pozitivno povezavo med koncentracijo vorikonazola v plazmi ter nenormalnostmi testov jetrne funkcije in motnjami vida.
Pharmacokinetics in special patient groups Gender In an oral multiple dose study, Cmax and AUCτ for healthy young females were 83% and 113% higher, respectively, than in healthy young males (18-45 years).
Spol V študiji večkratnih peroralnih odmerkov je bila pri zdravih mladih ženskah Cmax 83% višja, AUCτ pa 113% višja kot pri zdravih mladih moških (18– 45 let).
In the same study, no significant differences in Cmax and AUCτ were observed between healthy elderly males and healthy elderly females (≥ 65 years).
V isti študiji niso ugotovili pomembnih razlik Cmax in AUCτ med zdravimi starejšimi moški in zdravimi starejšimi ženskami (≥ 65 let).
Elderly In an oral multiple dose study Cmax and AUCτ in healthy elderly males (≥ 65 years) were 61% and 86% higher, respectively, than in healthy young males (18-45 years).
Starejši V študiji večkratnih peroralnih odmerkov je bila Cmax pri zdravih starejših moških (≥ 65 let) 61% višja, AUCτ pa 86% višja kot pri zdravih mladih moških (18– 45 let).
No significant differences in Cmax and AUCτ were observed between healthy elderly females (≥ 65 years) and healthy young females (18- 45 years).
Med zdravimi starejšimi ženskami (≥ 65 let) in zdravimi mladimi ženskami (18– 45 let) niso ugotovili pomembnih razlik v Cmax in AUCτ.
The safety profile of voriconazole in young and elderly patients was similar and, therefore, no dosage adjustment is necessary for the elderly (see section 4.2).
Varnostni profil vorikonazola je bil pri mladih in starejših bolnikih podoben, zato pri starejših odmerka ni treba prilagajati (glejte poglavje 4. 2).
Paediatric The recommended oral dose in paediatrics is based on a population pharmacokinetic analysis of data obtained from 47 immunocompromised paediatric patients aged 2 to < 12 years old who were evaluated in a pharmacokinetic study examining multiple oral suspension doses of 4 and 6 mg/ kg twice daily.
Bolniki so bili vključeni v farmakokinetično študijo, ki je proučevala večkratne odmerke peroralne suspenzije v odmerkih 4 in 6 mg/ kg dvakrat na dan.