FrancophonIA/ELRC3.0 huggingface dataset:
English: Long term exposure (treatment or prophylaxis) greater than 180 days (6 months) requires careful assessment of the benefit-risk balance and physicians should therefore consider the need to limit the exposure to VORICONAZOLE HIKMA (see sections 4.2 and 5.1).
Croatian: Dugotrajno izlaganje (liječenje ili profilaksa) duže od 180 dana (6 mjeseci) zahtijeva temeljitu procjenu omjera koristi i rizika pa stoga liječnici trebaju razmotriti treba li ograničiti izloženost lijeku VORIKONAZOL HIKMA (vidjeti dijelove 4.2 i 5.1).
English: Tacrolimus (0.1 mg/kg single dose)
Croatian: Takrolimus (jedna doza od 0,1 mg/kg)
English: In the therapeutic studies no dosage adjustment was made on the basis of age.
Croatian: U ispitivanjima s terapijskom primjenom lijeka doze se nisu prilagođavale s obzirom na dob.
English: Ranitidine (150 mg BID) [increases gastric pH]
Croatian: Ranitidin (150 mg BID) [povisuje želučani pH]
English: In the table below, since the majority of the studies were of an open nature all causality adverse reactions, and their frequency categories in 1,873 adults from pooled therapeutic (1,603) and prophylaxis (270) studies, by system organ classare listed.
Croatian: S obzirom da je većina ispitivanja bila otvorenog tipa, u sljedećoj su tablici navedene nuspojave svih uzroka i kategorije učestalosti kod 1873 odrasle osobe iz kombiniranih terapeutskih (1603) i profilaktičkih (270) ispitivanja, razvrstane prema organskim sustavima.
English: Use in paediatric patients aged 2 to <12 years with hepatic or renal insufficiency has not been studied (see sections 4.8 and 5.2).
Croatian: Nije se ispitivala primjena u pedijatrijskih bolesnika u dobi od 2 do < 12 godina s oštećenjem jetre ili bubrega (vidjeti dijelove 4.8 i 5.2).
English: Voriconazole Hikma must not be diluted with 4.2% Sodium Bicarbonate Infusion.
Croatian: Vorikonazol Hikma se ne smije razrjeđivati s 4,2% otopinom natrijevog bikarbonata za infuziju.
English: Subjects who are heterozygous extensive metabolisers have on average 2-fold higher voriconazole exposure than their homozygous extensive metaboliser counterparts.
Croatian: Ispitanici koji su heterozigotni brzi metabolizatori izloženi su vorikonazolu u prosjeku dvostruko više nego odgovarajući im homozigotni brzi metabolizatori.
English: Careful monitoring of full blood counts and adverse reactions to rifabutin (e.g., uveitis) is recommended when rifabutin is co-administered with voriconazole.
Croatian: Preporučuje se pažljivo praćenje kompletne krvne slike i nuspojava rifabutina (npr. uveitisa) kada ga se primjenjuje istodobno s vorikonazolom.
English: As GPMT (guinea pig maximisation test) result was positive, prescribers should be aware of the hypersensitivity potential of the intravenous formulation.
Croatian: S obzirom da je rezultat GPMT testa (testa senzibilizacije na zamorcima) bio pozitivan, liječnici propisivači moraju imati na umu da intravenski oblik vorikonazola može izazvati reakcije preosjetljivosti.
English: A higher frequency of liver enzyme elevations was observed in the paediatric population (see section 4.8).
Croatian: . Kod pedijatrijske populacije primijećena je veća učestalost povišenih enzima jetre (vidjeti dio 4.8).
English: Ritonavir (potent CYP450 inducer; CYP3A4 inhibitor and substrate) Co-administration of voriconazole and low dose ritonavir (100 mg twice daily) should be avoided unless an assessment of the benefit/risk to the patient justifies the use of voriconazole (see sections 4.5 and 4.3).
Croatian: Ritonavir (snažan induktor CYP450; inhibitor i supstrat CYP3A4) Treba izbjegavati istodobnu primjenu vorikonazola i niske doze ritonavira (100 mg dvaput na dan) osim ako se procijeni da omjer koristi i rizika za bolesnika opravdava primjenu vorikonazola (vidjeti dijelove 4.3 i
English: Ciclosporin Cmax ↑ 13% Ciclosporin AUCτ ↑ 70%
Croatian: Ciklosporin Cmax ↑13% Ciklosporin AUCτ ↑70%
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili ljekarniku ili medicinskoj sestri.
English: 4 EUCAST has not determined non-species related breakpoints for voriconazole.
Croatian: 4 EUCAST za vorikonazol nije utvrdio granične vrijednosti nevezane za vrstu.
English: Three hundred and seventy non-neutropenic patients (above 12 years of age) with documented candidaemia were included in the study, of whom 248 were treated with voriconazole.
Croatian: U ispitivanje je bilo uključeno 370 bolesnika (starijih od 12 godina) s dokazanom kandidemijom no bez neutropenije, od kojih je njih 248 liječeno vorikonazolom.
English: Infusions of blood products must not occur simultaneously with Voriconazole Hikma.
Croatian: Infuzija krvnih pripravaka ne smije se odvijati u isto vrijeme s primjenom lijeka Vorikonazol Hikma.
English: Although not studied, increased plasma concentrations of these medicinal products can lead to QTc prolongation and rare occurrences of torsades de pointes.
Croatian: Iako nije ispitivano, povišene koncentracije ovih lijekova u plazmi mogu dovesti do produljenja QTc-intervala, a u rijetkim slučajevima i do torsades de pointes.
English: Breast-feeding must be stopped on initiation of treatment with Voriconazole Hikma.
Croatian: Dojenje se mora prekinuti prije početka liječenja lijekom Vorikonazol Hikma.
English: Co-administration of voriconazole and low dose ritonavir (100 mg BID) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole.
Croatian: Istodobnu primjenu vorikonazola i niske doze ritonavira (100 mg BID) treba izbjegavati, osim kad procjena odnosa koristi i rizika za bolesnika opravdava primjenu vorikonazola.
English: See leaflet for further information.
Croatian: Za dodatne informacije pogledajte Uputu o lijeku.
English: After reconstitution each ml contains 10 mg of voriconazole.
Croatian: Nakon pripreme, 1 ml sadrži 10 mg vorikonazola.
English: • Congenital or acquired QTc-prolongation
Croatian: • prirođeno ili stečeno produljenje QTc-intervala
English: What you need to know before you take Voriconazole Hikma
Croatian: Što morate znati prije nego počnete primati Vorikonazol Hikma
English: It is recommended that voriconazole is administered at a maximum rate of 3 mg/kg per hour over 1 to 3 hours.
Croatian: Preporučuje se primjenjivati vorikonazol tijekom razdoblja od 1 do 3 sata, uz maksimalnu brzinu infuzije od 3 mg/kg na sat.
English: Astemizole, cisapride, pimozide, quinidine and terfenadine [CYP3A4 substrates]
Croatian: Astemizol, cisaprid, pimozid, kinidin i terfenadin [supstrati CYP3A4]
English: 3 Includes nuchal rigidity and tetany.
Croatian: 3 Uključuje zakočenost šije i tetaniju.
English: Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) [CYP2C9 substrates] Ibuprofen (400 mg single dose)
Croatian: Nesteroidni protuupalni lijekovi (NSAIL) [supstrati CYP2C9] Ibuprofen (jedna doza od 400 mg)
English: Other treated fungal infections (often with 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.
Croatian: Ostale liječene gljivične infekcije (često s djelomičnim ili potpunim odgovorom) obuhvaćaju izolirane slučajeve infekcija uzrokovanih vrstama iz roda Alternaria, Blastomyces dermatitidis, Blastoschizomyces capitatus, vrstama iz roda Cladosporium, Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, vrstama iz roda Penicillium uključujući P.marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis i vrstama iz roda Trichosporon, uključujući T. beigelii.
English: When initiating voriconazole in patients already on ciclosporin it is recommended that the ciclosporin dose be halved and ciclosporin level carefully monitored.
Croatian: Kad se započinje primjena vorikonazola u bolesnika koji već primaju ciklosporin, preporučuje se prepoloviti dozu ciklosporina i pažljivo kontrolirati razinu ciklosporina.
English: Sulfonylureas (e.g., tolbutamide, glipizide, glyburide) [CYP2C9 substrates]
Croatian: Sulfonilureje (npr. tolbutamid, glipizid, gliburid) [supstrati CYP2C9]
English: If you are already being treated with phenytoin, your blood concentration of phenytoin will need to be monitored during your treatment with Voriconazole Hikma and your dose may be adjusted.
Croatian: Ako već primate fenitoin, za vrijeme liječenja lijekom Vorikonazol Hikma morat će se pratiti koncentracija fenitoina u krvi i možda prilagoditi doza lijeka.
English: • Exfoliative cutaneous reactions
Croatian: • Eksfolijativne kožne reakcije
English: Ethinylestradiol Cmax ↑ 36% Ethinylestradiol AUCτ ↑ 61% Norethisterone Cmax ↑ 15% Norethisterone AUCτ ↑ 53% Voriconazole Cmax ↑ 14% Voriconazole AUCτ ↑ 46%
Croatian: Etinilestradiol Cmax ↑36% Einilestradiol AUCτ ↑61% Noretisteron Cmax ↑15% Noretisteron AUCτ ↑53% Vorikonazol Cmax ↑14% Vorikonazol AUCτ ↑46%
English: Tell your doctor if you are taking either of the following medicines, as treatment with Voriconazole Hikma at the same time should be avoided if possible, and a dose adjustment of voriconazole may be required:
Croatian: Obavijestite svog liječnika ako uzimate bilo koji od sljedećih lijekova jer treba izbjegavati istodobno liječenje lijekom Vorikonazol Hikma, a možda će biti potrebno i prilagoditi dozu vorikonazola:
English: Macrolide antibiotics Erythromycin (1 g BID) [CYP3A4 inhibitor] Azithromycin (500 mg QD)
Croatian: Eritromicin (1 g BID) [inhibitor CYP3A4] Azitromicin (500 mg QD)
English: • Squamous cell carcinoma of the skin (SCC)
Croatian: • Karcinom skvamoznih stanica kože (SCC, engl. squamous cell carcinoma)
English: A relationship between plasma concentrations and age was observed.
Croatian: Uočena je povezanost koncentracije u plazmi i dobi.
English: The majority of patients receiving voriconazole treatment of the above mentioned rare infections were intolerant of, or refractory to, prior antifungal therapy.
Croatian: U većine bolesnika liječenih vorikonazolom zbog spomenutih rijetkih infekcija prethodno liječenje drugim antimikoticima nije bilo uspješno ili ih nisu podnosili.
English: In that case, intravenous voriconazole administration is recommended.
Croatian: U tom se slučaju preporučuje intravenska primjena vorikonazola.
English: Patients have developed severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) (uncommon), toxic epidermal necrolysis (TEN) (rare), drug reaction with eosinophilia and systemic symptoms (DRESS) (rare) and erythema multiforme (rare) during treatment with voriconazole (see section 4.4).
Croatian: Bolesnici su tijekom primjene vorikonazola razvijali teške kožne nuspojave (SCARs), uključujući Stevens-Johnsonov sindrom (SJS) (manje često), toksičnu epidermalnu nekrolizu (TEN) (rijetko), reakciju na lijek s eozinofilijom i sistemskim simptomima (DRESS) (rijetko) i multiformni eritem (rijetko) (vidjeti dio 4.4).
English: Co-administration with CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine since increased plasma concentrations of these medicinal products can lead to QTc prolongation and rare occurrences of torsades de pointes (see section 4.5).
Croatian: Istodobna primjena sa supstratima enzima CYP3A4, terfenadinom, astemizolom, cisapridom, pimozidom ili kinidinom, jer porast koncentracije ovih lijekova u plazmi može dovesti do produljenja QTc intervala i u rijetkim slučajevima do pojave torsades de pointes (vidjeti dio 4.5.).
English: Co-administration of voriconazole and high doses of ritonavir (400 mg and above BID) is contraindicated (see section 4.3).
Croatian: Istodobna primjena vorikonazola i visokih doza ritonavira (400 mg BID i više) je kontraindicirana (vidjeti dio 4.3).
English: If phototoxic reactions occur multidisciplinary advice should be sought, VORICONAZOLE HIKMA discontinuation and use of alternative antifungal agents should be considered and the patient should be referred to a dermatologist.
Croatian: Ako se pojavi fototoksična reakcija, treba zatražiti savjet multidisciplinarnog tima, razmotriti prekid primjene lijeka VORIKONAZOL HIKMA i primjenu zamjenskih antimikotika te bolesnika uputiti dermatologu.
English: Methadone (32-100 mg QD) [CYP3A4 substrate]
Croatian: Metadon (32-100 mg QD) [supstrat CYP3A4]
English: Oral bioavailability may be limited in paediatric patients aged 2 to <12 years with malabsorption and very low body weight for age.
Croatian: Bioraspoloživost nakon peroralne primjene može biti ograničena u djece u dobi od 2 do < 12 godina ako imaju malapsorpciju ili premalu tjelesnu težinu za dob.
English: If patient is unable to tolerate treatment at a higher dose reduce the oral dose by 50 mg steps to the 200 mg twice daily (or 100 mg twice daily for patients less than 40 kg) maintenance dose.
Croatian: Ako bolesnik ne podnosi liječenje tom povišenom dozom, treba smanjivati peroralnu dozu u koracima od 50 mg do doze održavanja od 200 mg dvaput na dan (odnosno 100 mg dvaput na dan u bolesnika tjelesne težine manje od 40 kg).
English: Voriconazole Hikma powder for solution for infusion will be reconstituted and diluted to the correct concentration by your hospital pharmacist or nurse.
Croatian: Hikma prašak za otopinu za infuziju će bolnički ljekarnik ili medicinska sestra pripremiti i razrijediti do točne koncentracije.
English: 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.
Croatian: Kod infekcija uzrokovanih drugim vrstama kandide osim C. albicans rezistentnima na flukonazol, pozitivan je odgovor zabilježen u 3/3 slučaja za C. krusei (potpun odgovor) i u 6/8 slučajeva za C. glabrata (5 potpunih, 1 djelomičan odgovor).
English: AUCτ, AUCt and AUC0-∞ represent area under the curve over a dosing interval, from time zero to the time with detectable measurement and from time zero to infinity, respectively.
Croatian: AUCτ predstavlja područje ispod krivulje koncentracija:vrijeme tijekom intervala doziranja, AUCt područje ispod krivulje od početne, nulte točke do vremena kad se izmjerila prva koncentracija lijeka, a AUC0-∞ područje ispod krivulje od početne, nulte točke do beskonačnosti.
English: Voriconazole Cmax and AUCτ ↔
Croatian: Vorikonazol Cmax and AUCτ
English: Median duration of IV voriconazole therapy was 10 days (range 2-85 days).
Croatian: Medijan trajanja intravenske primjene vorikonazola bio je 10 dana (raspon 285 dana).
English: In an open-label, comparative, multicenter study comparing voriconazole and itraconazole as primary prophylaxis in adult and adolescent allogeneic HSCT recipients without prior proven or probable IFI, permanent discontinuation of voriconazole due to AEs was reported in 39.3% of subjects versus 39.6% of subjects in the itraconazole arm. Treatment-emergent hepatic AEs resulted in permanent discontinuation of study medication for 50 subjects (21.4%) treated with voriconazole and for 18 subjects (7.1%) treated with itraconazole.
Croatian: U otvorenom, usporednom, multicentričnom ispitivanju, u kojem su uspoređivani vorikonazol i itrakonazol kao primarna profilaksa u odraslih i u adolescentnih primatelja alogene transplantacije hematopoetskih matičnih stanica, bez prethodne dokazane ili vjerojatne invazije gljivične infekcije, trajni prekid liječenja vorikonazolom zbog nuspojava prijavljen je u 39,3% ispitanika u usporedbi s 39,6% ispitanika u skupini koja je primala itrakonazol.
English: Itraconazole (N=143)
Croatian: Itrakonazol (N=143)
English: Chemical and physical in-use stability has been demonstrated for 36 hours at 2°C to 8° C for the reconstituted solution.
Croatian: Za pripremljenu otopinu kemijska i fizikalna stabilnost dokazana je tijekom 36 sati na 2°C do 8°C.
English: The maintenance dose of voriconazole may be increased to 5 mg/kg intravenously BID or from 200 mg to 350 mg orally BID (100 mg to 200 mg orally BID in patients less than 40 kg) (see section 4.2).
Croatian: Doza održavanja vorikonazola može se povisiti na 5 mg/kg BID intravenski, ili s 200 mg na 350 mg BID peroralno (sa 100 mg na 200 mg BID peroralno u bolesnika tjelesne težine manje od 40 kg) (vidjeti dio 4.2).
English: Patients less than 40 kg**
Croatian: 40 kg**
English: Other HIV Protease Inhibitors (e.g., saquinavir, amprenavir and nelfinavir)* [CYP3A4 substrates and inhibitors]
Croatian: Drugi inhibitori HIV proteaze (npr. sakvinavir, amprenavir i nelfinavir)* [supstrati i inhibitori CYP3A4]
English: What Voriconazole Hikma contains - The active substance is voriconazole.
Croatian: Što Vorikonazol Hikma sadrži - Djelatna tvar je vorikonazol.
English: 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.
Croatian: Bez primjene udarne doze dolazi do akumulacije lijeka tijekom višekratne primjene dva puta na dan, a u većine se ispitanika stanje dinamičke ravnoteže vorikonazola u plazmi postiže do 6. dana primjene.
English: • Astemizole (used for allergy)
Croatian: • astemizol (koristi se za liječenje alergija)
English: • Treatment of candidaemia in non-neutropenic patients
Croatian: • liječenje kandidemije u bolesnika koji nemaju neutropeniju,
English: Visual impairments
Croatian: Oštećenja vida
English: Stevens-Johnson syndrome, phototoxicity, purpura, urticaria, dermatitis allergic, rash papular, rash macular, eczema toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), angioedema, Actinic keratosis*, pseudoporphyria erythema multiforme, psoriasis, drug eruption cutaneous lupus erythemato sus* ephelides*, lentigo*
Croatian: Johnsonov sindrom, fototoksičnost, purpura, urtikarija, alergijski dermatitis, papularni osip, makularni osip, ekcem toksična epidermalna nekroliza, reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS), angio edem, aktiničkakeratoz a*, multiformni pseudoporfrijski eritem, psorijaza, reakcija na koži kožni lupus eritematodes *, pjege*, lentigo*
English: Each vial contains 200 mg voriconazole, equivalent to 10 mg/ml solution when reconstituted as directed by your hospital pharmacist or nurse.
Croatian: Jedna bočica sadrži 200 mg vorikonazola, što odgovara koncentraciji otopine od 10 mg/ml nakon što je bolnički ljekarnik ili medicinska sestra pripreme prema uputama.
English: Rifabutin [potent CYP450 inducer] 300 mg QD
Croatian: Rifabutin [snažan induktor CYP450] 300 mg QD
English: Cimetidine (400 mg BID) [non-specific CYP450 inhibitor and increases gastric pH]
Croatian: Cimetidin (400 mg BID) [nespecifičan inhibitor CYP450 koji povisuje želučani pH]
English: • Rifampicin (used for treating tuberculosis)
Croatian: • rifampicin (koristi se za liječenje tuberkuloze)
English: Liver dysfunction has usually been reversible on discontinuation of therapy (see section 4.8).
Croatian: Obično je nakon prekida terapije došlo do oporavka funkcije jetre (vidjeti dio 4.8).
English: Metabolism and nutrition disorders oedema peripheral hypoglycaemia, hypokalaemia, hyponatraemia
Croatian: Poremećaji metabolizma i prehrane periferni edem hipoglikemija, hipokalijemija, hiponatremija
English: Voriconazole was compared to itraconazole as primary prophylaxis in an open-label, comparative, multicenter study of adult and adolescent allogeneic HSCT recipients without prior proven or probable IFI.
Croatian: Vorikonazol je uspoređen s itrakonazolom kao primarna profilaksa u otvorenom, usporednom, multicentričnom ispitivanju u odraslih i adolescentnih primatelja alogene HSCT bez prethodne dokazane ili vjerojatne invazivne gljivične infekcije.
English: Effective contraception must be used in women of childbearing potential.
Croatian: Žene reproduktivne dobi trebaju koristiti učinkovitu kontracepciju.
English: Dose after the first 24 hours (Maintenance Dose)
Croatian: Doza nakon prva 24 sata (doza održavanja)
English: Unless otherwise specified, drug interaction studies have been performed in healthy adult male subjects using multiple dosing to steady state with oral voriconazole at 200 mg twice daily (BID).
Croatian: Ako nije navedeno drugačije, ispitivanja interakcija s drugim lijekovima provedena su u zdravih odraslih muškaraca, uz višekratnu primjenu peroralne doze vorikonazola od 200 mg dvaput na dan do postizanja stanja dinamičke ravnoteže.
English: Itraconazole (N=109)
Croatian: Itrakonazol (N=109)
English: Mycophenolic acid Cmax ↔ Mycophenolic acid AUCt ↔
Croatian: Mikofenolna kiselina Cmax ↔ Mikofenolna kiselina AUCt ↔
English: There have been rare cases of torsades de pointes in patients taking voriconazole who had risk factors, such as history of cardiotoxic chemotherapy, cardiomyopathy, hypokalaemia and concomitant medicinal products that may have been contributory.
Croatian: Opisani su rijetki slučajevi torsades de pointes u bolesnika koji su uzimali vorikonazol, a uz to su imali i neke dodatne faktore rizika, kao što su prethodna kardiotoksična kemoterapija, kardiomiopatija, hipokalemija te istodobno uzimanje nekih lijekova koji su mogli pridonijeti nastanku torsades de pointes.
English: When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored (see sections 4.4 and 4.5).
Croatian: Kada se prekine liječenje vorikonazolom, treba ponovno uspostaviti početnu dozu efavirenza (vidjeti dijelove 4.4 i 4.5.).
English: Benzodiazepines (e.g., midazolam, triazolam, alprazolam) [CYP3A4 substrates]
Croatian: Benzodiazepini (npr. midazolam, triazolam, alprazolam) [supstrati CYP3A4]
English: If a patient develops skeletal pain and radiologic findings compatible with periostitis VORICONAZOLE HIKMA discontinuation should be considered after multidisciplinary advice.
Croatian: Ako se u bolesnika razvije bol u skeletu, a radiološki nalazi upućuju na periostitis, nakon multidisciplinarnog savjetovanja treba razmotriti prekid primjene lijeka VORIKONAZOL HIKMA.
English: Monitoring of serum amylase or lipase may be considered in this clinical situation.
Croatian: Pri ovakvom kliničkom stanju može se razmotriti praćenje vrijednosti amilaza ili lipaza u serumu.
English: • Efavirenz (used for treating HIV) in doses of 400 mg and above once daily
Croatian: • efavirenz (koristi se za liječenje HIV-a) u dozama od 400 mg i više jednom na dan
English: It should be noted that an 8 mg/kg intravenous dose will provide voriconazole exposure approximately 2-fold higher than a 9 mg/kg oral dose.
Croatian: Treba napomenuti da će intravenska doza od 8 mg/kg dovesti do približno dvostruke izloženosti vorikonazolu u odnosu na peroralnu dozu od 9 mg/kg.
English: 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 (interquartile range 2027 to 6302 ng/ml), respectively.
Croatian: U 10 ispitivanja s terapijskom primjenom lijeka medijan prosječnih plazmatskih koncentracija u pojedinačnih ispitanika u svim ispitivanjima bio je 2425 ng/ml (interkvartilni raspon od 1193 do 4380
English: 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).
Croatian: U jednom ispitivanju s višekratnom primjenom peroralne doze lijeka Cmax i AUCτ je u zdravih starijih muškaraca bio je 61% , odnosno 86% veći nego u zdravih mladih muškaraca (18-45 godina).
English: • Ritonavir (used for treating HIV) in doses of 400 mg and more twice daily
Croatian: • ritonavir (koristi se za liječenje HIV-a) u dozama od 400 mg i više dva puta na dan
English: Voriconazole (N=248)
Croatian: Vorikonazol (N=248)