natgillin/translations-raw huggingface dataset:
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. No subject in any group had an increase in QTc of ≥60 msec from baseline.
Srednja vrijednost maksimalnog produljenja QTcintervala u odnosu na početne vrijednosti, korigirana za placebo, iznosila je 5,1 ms kod primjene doze vorikonazola od 800 mg, 4,8 ms kod primjene doze od 1200 mg te 8,2 ms kod primjene doze od 1600 mg, dok je kod primjene ketokonazola u dozi od 800 mg produljenje iznosilo 7,0 ms.
Ritonavir Cmax and AUCτ ↔ Voriconazole Cmax  66% Voriconazole AUCτ  82%
Ritonavir Cmax and AUC ↔ Vorikonazol Cmax  66% Vorikonazol AUC  82%
Ritonavir Cmax  25% Ritonavir AUCτ  13% Voriconazole Cmax  24% Voriconazole AUCτ  39%
Ritonavir Cmax  25% Ritonavir AUC 13% Vorikonazol Cmax  24% Vorikonazol AUC  39%
- Inflammation of the sinuses, inflammation of the gums, chills, weakness - Low numbers of some types, including severe, of red (sometimes immune-related) and/or white blood cells (sometimes with fever), low numbers of cells called platelets that help the blood to clot - Low blood sugar, low blood potassium, low sodium in the blood - Anxiety, depression, confusion, agitation, inability to sleep, hallucinations - Seizures, tremors or uncontrolled muscle movements, tingling or abnormal skin sensations,
- upala sinusa, upala desni, zimica, slabost - smanjen (uključujući i značajno smanjen) broj nekih vrsta crvenih (katkad povezano s imunitetom) i/ili bijelih krvnih stanica (katkad popraćeno temperaturom), niski broj stanica koje se nazivaju trombociti i koje pomažu u zgrušavanju krvi - nizak šećer u krvi, nizak kalij u krvi, nizak natrij u krvi - tjeskoba, depresija, smetenost, uznemirenost, nemogućnost spavanja, halucinacije - napadaji, nevoljno drhtanje ili nekontrolirani pokreti mišića, trnci ili neuobičajen osjet na koži,
200 mg every 12 hours for the first 24 hours
200 mg svakih 12 sati tijekom prva 24 sata
Efavirenz Cmax  38% Efavirenz AUCτ  44% Voriconazole Cmax  61% Voriconazole AUCτ  77%
Efavirenz Cmax  38% Efavirenz AUC  44% Vorikonazol Cmax  61% Vorikonazol AUC  77%
It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh A and B) receiving voriconazole (see section 5.2).
Preporučuje se da se u bolesnika s blagom do umjerenom cirozom jetre (Child-Pugh stadij A i B) koji dobivaju vorikonazol liječenje započne standardnom udarnom dozom, no da se doza održavanja prepolovi (vidjeti dio 5.2).
Hepatobiliary disorders liver function test abnormal jaundice, jaundice cholestatic, hepatitis10
Poremećaji jetre i žuči abnormalne vrijednosti testova funkcije jetre žutica, žutica kolestatska, hepatitis10
Treatment of serious fungal infections caused by Scedosporium spp.
Liječenje teških gljivičnih infekcija uzrokovanih vrstama iz rodova Scedosporium i Fusarium.
Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02A C03 Mode of action
Farmakoterapijska skupina: Antimikotici za sistemsku primjenu, derivati triazola.
[CYP3A4 substrates, inhibitors or CYP450 inducers]
[supstrati CYP3A4, inhibitori ili induktori CYP450]
General disorders and administratio n site conditions pyrexia chest pain, face oedema11, asthenia, chills infusion site reaction, influenza like illness
Opći poremećaji i reakcije na mjestu primjene pireksija bol u prsištu, edem lica11, astenija, zimica reakcija na mjestu infuzije, bolest nalik gripi
How to store Voriconazole Accord
Kako čuvati Voriconazole Accord
N=224
Vorikonazol N=224
Voriconazole is haemodialysed with a clearance of 121 ml/min.
Vorikonazol se odstranjuje hemodijalizom i klirens mu iznosi 121 ml/min.
Efavirenz may be coadministered with voriconazole if the maintenance dose of voriconazole is increased to 400 mg every 12 hours and the efavirenz dose is reduced by 50 %, i.e. to 300 mg once daily.
Efavirenz se smije primjenjivati istodobno s vorikonazolom ako se doza održavanja vorikonazola poveća na 400 mg svakih 12 sati, a doza efavirenza smanji za 50%, tj. na 300 mg jedanput na dan.
achieves a voriconazole exposure similar to 3 mg/kg IV. A 300 mg (or 150 mg for patients less than 40 kg) oral maintenance dose achieves an exposure similar to 4 mg/kg IV.
Peroralnom dozom održavanja od 300 mg (ili 150 mg za bolesnike tjelesne težine manje od 40 kg) postiže se podjednaka izloženost kao kod intravenske primjene doze od 4 mg/kg.
Voriconazole Accord contains lactose
Voriconazole Accord sadrži laktozu
Therefore, no adjustment is necessary for oral dosing for patients with mild to severe renal impairment (see section 5.2).
Stoga nije potrebno prilagođavati dozu kod peroralne primjene vorikonazola u bolesnika s blagim do teškim oštećenjem bubrega (vidjeti dio 5.2).
Success at Day 180* * Primary endpoint of study ** Using a margin of 5%, non inferiority is demonstrated *** Difference in proportions, 95% CI obtained after adjustment for randomization
* Primarni ishod ispitivanja ** Uz primjenu granice od 5%, dokazana je neinferiornost ***Razlika u udjelima, 95%-tni CI dobiven nakon prilagodbe za randomizaciju
Aspergillus infections - efficacy in aspergillosis patients with poor prognosis Voriconazole has in vitro fungicidal activity against Aspergillus spp.
Infekcije uzročnikom Aspergillus - djelotvornost u bolesnika s aspergilozom s lošom prognozom
Monitoring for voriconazole-associated adverse reactions is recommended if voriconazole is used sequentially after fluconazole (see section 4.5).
Preporučuje se nadzor kako bi se uočile nuspojave povezane s vorikonazolom ako se vorikonazol primjenjuje nakon liječenja flukonazolom (vidjeti dio 4.5).
When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored (see sections 4.4 and 4.5)
Kad se prekine liječenje vorikonazolom, treba se vratiti na prijašnju dozu efavirenza (vidjeti dijelove 4.4. i 4.5).
In vitro studies showed that voriconazole is metabolised by, the hepatic cytochrome P450 isoenzymes CYP2C19, CYP2C9 and CYP3A4.
Ispitivanja in vitro pokazala su da se vorikonazol metabolizira pomoću jetrenih izoenzima citokroma P450, i to CYP2C19, CYP2C9 i CYP3A4.
Fluconazole(CYP2C9, CYP2C19 and CYP3A4 inhibitor)
Flukonazol (inhibitor CYP2C9, CYP2C19 i CYP3A4)
Voriconazo le (N=98)
Vorikonazol (N=98)
Ethinylestradiol Cmax  36% Ethinylestradiol AUCτ  61% Norethisterone Cmax  15% Norethisterone AUCτ  53% Voriconazole Cmax  14%
Etinilestradiol Cmax  36% Etinilestradiol AUC  61% Noretisteron Cmax  15% Noretisteron AUC  53% Vorikonazol Cmax  14% Vorikonazol AUC  46%
Bipolaris spp., Cladophialophora spp., and Histoplasma capsulatum, with most strains being inhibited by concentrations of voriconazole in the range 0.05 to 2 μg/ml.
Zabilježena je aktivnost in vitro protiv kliničkih izolata vrsta iz rodova Acremonium, Alternaria, Bipolaris i Cladophialophora te Histoplasma capsulatum, gdje je najveći broj sojeva bio inhibiran pri koncentracijama vorikonazola u rasponu od 0,05 do 2 µg/ml.
However, if the combination is strictly needed, the maintenance dose of voriconazole may be increased from 200 mg to 350 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see sections 4.4 and 4.5.
Međutim, ako je ta kombinacija neophodna, doza održavanja vorikonazola može se povećati s 200 mg na 350 mg peroralno dvaput na dan (sa 100 mg na 200 mg peroralno dva puta na dan u bolesnika tjelesne težine manje od 40 kg), vidjeti dijelove 4.4 i 4.5.
Voriconazole Accord contains the active substance voriconazole.
Voriconazole Accord sadrži djelatnu tvar vorikonazol.
• Congenital or acquired QTc -prolongation.
• urođeno ili stečeno produljenje QTc-intervala.
Efavirenz (CYP450 inducer; CYP3A4 inhibitor and substrate)
Efavirenz (induktor CYP450; inhibitor i supstrat CYP3A4)
Nervous system disorders headache convulsion, syncope, tremor, hypertonia3, paraesthesia, somnolence, dizziness brain oedema, encephalopathy4, extrapyramidal disorder5, neuropathy peripheral, ataxia, hypoaesthesia, dysgeusia hepatic encephalopathy , Guillain-Barre syndrome, nystagmus
Poremećaji živčanog sustava glavobolja konvulzije, sinkopa, tremor, hipertonija3, parestezija, somnolencija, omaglica edem mozga, encefalopatija4, ekstrapiramidni poremećaj5, periferna neuropatija,
Seven (3 complete, 4 partial responses) of 17 patients were successfully treated with voriconazole.
Sedam od ukupno 17 bolesnika liječenih vorikonazolom uspješno je odgovorilo na terapiju (3 potpuna, 4 djelomična odgovora).
Compared to voriconazole 200 mg BID,
U usporedbi s dozom vorikonazola od 200 mg BID,
(a maximum dose of 350 mg twice daily) Note: Based on a population pharmacokinetic analysis in 112 immunocompromised paediatricpatients aged 2 to <12 years and 26 immunocompromised adolescents aged 12 to <17 years.
Na temelju populacijske farmakokinetičke analize u 112 imunokompromitiranih pedijatrijskih bolesnika u dobi od 2 do < 12 godina te 26 imunokompromitiranih adolescenata u dobi od 12 do < 17 godina.
Prednisolone Cmax  11% Prednisolone AUC0-∞  34%
Prednizolon Cmax  11% Prednizolon AUC0-  34%
What Voriconazole Accord looks like and contents of the pack Voriconazole Accord 50 mg film-coated tablets are supplied as white to off white, round, approximate 7.0mm in diameter, film-coated tablets, debossed with ‘V50' on one side and plain on the other side.
Kako Voriconazole Accord izgleda i sadržaj pakiranja Voriconazole Accord 50 mg filmom obložene tablete su bijele do gotovo bijele, okrugle filmom obložene tablete promjera otprilike 7,0 mm s utisnutom oznakom "V50" na jednoj i bez oznake na suprotnoj strani.
Each tablet contains either 50 mg voriconazole (for Voriconazole Accord 50 mg film-coated tablets) or 200 mg voriconazole (for VoriconazoleAccord 200 mg film-coated tablets).
Jedna tableta sadrži ili 50 mg vorikonazola (Voriconazole Accord 50 mg filmom obložene tablete) ili 200 mg vorikonazola (Voriconazole Accord 200 mg filmom obložene tablete).
QUALITATIVE AND QUANTITATIVE COMPOSITION Voriconazole Accord 50 mg film-coated tablets Each tablet contains 50 mg voriconazole.
KVALITATIVNI I KVANTITATIVNI SASTAV Voriconazole Accord 50 mg filmom obložene tablete Jedna tableta sadrži 50 mg vorikonazola.
hepatic failure, hepatomegaly, cholecystitis, cholelithiasis
zatajenje jetre, hepatomegalija, kolecistitis, kolelitijaza
Voriconazole Cmax  104% Voriconazole AUCτ  87%
Vorikonazol Cmax  104% Vorikonazol AUC  87%
A placebo-controlled, randomized, single-dose, crossover study to evaluate the effect on the QTc interval of healthy volunteers was conducted with three oral doses of voriconazole and ketoconazole.
U placebom kontroliranom, randomiziranom, ukrižanom ispitivanju s jednokratnom primjenom lijeka praćen je učinak lijeka na QTc-interval u zdravih ispitanika.
Careful monitoring of phenytoin levels is recommended when phenytoin is coadministered with voriconazole.
Preporučuje se pažljivo praćenje koncentracije fenitoina kada ga se primjenjuje istodobno s vorikonazolom.
If you take more Voriconazole Accord than you should If you take more tablets than prescribed (or if someone else takes your tablets) you must seek medical advice or go to the nearest hospital casualty department immediately.
Vaše tablete), morate odmah zatražiti savjet liječnika ili otići u hitnu službu najbliže bolnice.
[potent CYP450 inducers]
[snažni induktori CYP450]
Rifabutin Cmax 195% Rifabutin AUCτ 331%
Rifabutin Cmax  195% Rifabutin AUC  331% U usporedbi s dozom vorikonazola od 200 mg BID,
- Visual impairment (change in vision including blurred vision, visual color alterations, abnormal intolerance to visual perception of light, colour blindness, eye disorder, halo vision, night blindness, swinging vision, seeing sparks, visual aura, visual acuity reduced, visual brightness,
- oštećenje vida (promjene vida koje uključuju zamagljeni vid, izmjene doživljaja boja, neuobičajeno nepodnošenje vizualnog doživljaja svjetlosti, sljepoću za boje, poremećaje oka, aureole oko izvora svjetlosti, noćnu sljepoću, ljuljajuću sliku, iskrenje pred očima, vizualnu auru, smanjenu oštrinu vida, vizualnu svjetlinu, gubitak dijela uobičajenog vidnog polja, točke pred očima) - vrućica - osip - mučnina, povraćanje, proljev - glavobolja
Voriconazole Accord is an antifungal medicine.
Voriconazole Accord je antimikotik.
optic disc swelling - Decreased sensitivity to touch - Abnormal sense of taste - Hearing difficulties, ringing in the ears, vertigo - Inflammation of certain internal organs- pancreas and duodenum, swelling and inflammation of the tongue - Enlarged liver, liver failure, gallbladder disease, gallstones - Joint inflammation, inflammation of the veins under the skin (which may be associated with the formation of a blood clot) - Inflammation of the kidney, proteins in the urine, damage to the kidney - Very fast heart rate or skipped heartbeats, sometimes with erratic electrical impulses - Abnormal electrocardiogram (ECG) - Blood cholesterol increased, blood urea increased - Allergic skin reactions (sometimes severe), including life-threatening skin condition that causes painful blisters and sores of the skin and mucous membranes, especially in the mouth,
oštećenje očnog živca s posljedičnim oštećenjem vida, oticanje vidnog diska - smanjen osjet dodira - poremećen osjet okusa - poteškoće sa sluhom, zvonjenje u ušima, vrtoglavica - upala određenih unutarnjih organa - gušterače i dvanaesnika, oticanje i upala jezika - povećanje jetre, zatajenje jetre, bolest žučnog mjehura, žučni kamenci - upala zglobova,upala vena ispod kože (što može biti povezano sa stvaranjem krvnog ugruška) - upala bubrega, bjelančevine u mokraći, oštećenje bubrega - vrlo brzi otkucaji srca ili preskočeni otkucaji srca, katkad s nasumičnim električnim impulsima - poremećaj elektrokardiograma (EKG-a) - povišen kolesterol u krvi, povišena ureja u krvi - alergijske kožne reakcije (ponekad teške), uključujući kožna stanja opasna po život koja uzrokuju bolne mjehure i rane na koži i sluznici, posebice u ustima, upalu kože, koprivnjaču,
Although not studied, voriconazole may increase the plasma concentrations of coumarins that may cause an increase in prothrombin time
Iako nije ispitivano, vorikonazol može povisiti koncentracije kumarina u plazmi, što može produljiti protrombinsko vrijeme.
Efavirenz 400 mg QD, coadministered with voriconazole 200 mg BID*
Efavirenz 400 mg QD, primijenjeno istodobno s vorikonazolom u dozi od 200 mg BID*
Ritonavir (potent CYP450 inducer; CYP3A4 inhibitor and substrate)
Ritonavir (snažan induktor CYP450; inhibitor i supstrat CYP3A4)
Voriconazole Accord tablets contain lactose and should not be given to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
[potent CYP450 inducer]
[snažan induktor CYP450]
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).The oral maintenance dose of 200 mg (or 100 mg for patients less than 40 kg)
Procjenjuje se da, u prosjeku, povećanje peroralne doze s 200 na 300 mg dvaput na dan dovodi do povećanja izloženosti lijeku (AUCτ) za 2,5 puta.
[CYP3A4 substrate; CYP2C19 inhibitor]
[supstrat CYP3A4; inhibitor CYP2C19]
If you or your child develops skin disorders, your doctor may refer you to a dermatologist, who after consultation may decide that it is important for you or your child to be seen on a regular basis.
Opekline od sunca ili teška kožna reakcija uslijed izlaganja svjetlosti ili suncu nastale su češće u djece Ako Vi ili Vaše dijete primijetite promjene na koži, Vaš liječnik može Vas uputiti dermatologu, koji nakon pregleda može ustanoviti da je važno da Vi ili Vaše dijete redovito dolazite na kontrolu.
2 In clinical studies, response to voriconazole in patients with C glabrata infections was 21% lower compared to C. albicans, C. parapsilosis and C. tropicalis.
glabrata bio 21% niži u odnosu na one infekcije čiji su uzročnici bili C. albicans, C. parapsilosis i C. tropicalis.
300 mg QD (coadministered with voriconazole 350 mg BID)*
300 mg QD (primijenjeno istodobno s vorikonazolom u dozi od 350 mg BID)*
The findings of the effect of efavirenz on voriconazole suggest that the metabolism of voriconazole may be induced by an NNRTI
Nalazi o djelovanju efavirenza na vorikonazol upućuju na to NNRTI može potaknuti metabolizam vorikonazola.
[non-specific CYP450 inhibitor and increases gastric pH]
[nespecifičan inhibitor CYP450 koji povisuje želučani pH]
Voriconazole Cmax  93% Voriconazole AUCτ  96%
Vorikonazol Cmax  93% Vorikonazol AUC  96%
The species most frequently involved in causing human infections include C. albicans, C. parapsilosis, C.tropicalis, C. glabrata andC.
Vrste koje najčešće uzrokuju infekcije u ljudi uključuju C. albicans, C. parapsilosis, C. tropicalis, C. glabrata i C. krusei, a uobičajene minimalne inhibicijske koncentracije (MIK) vorikonazola za sve navedene vrste iznose manje od 1 mg/l.
[P-gp substrate]
[supstrat P-glikoproteina]
Your doctor should also monitor your liver function while you are being treated with Voriconazole Accord by doing blood tests.
Za vrijeme liječenja lijekom Voriconazole Accord liječnik također mora pratiti funkciju Vaše jetre putem krvnih pretraga.
[CYP450 inducer; P-gp inducer]
[induktor CYP450; induktor P-glikoproteina]
increase in muscle tone, sleepiness, dizziness - Bleeding in the eye - Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting, low blood pressure, inflammation of a vein (which may be associated with the formation of a blood clot)
povećana napetost mišića, pospanost, omaglica - krvarenje u oku - problemi sa srčanim ritmom uključujući vrlo brze otkucaje srca, vrlo spore otkucaje srca,
In an oral multiple dose study, Cmax and AUCτ for healthy young females were 83% and 113% higher,
U ispitivanju s višekratnom primjenom peroralne doze lijeka Cmax je u zdravih mladih žena bio 83% veći, a AUCτ 113% veći nego u zdravih mladih muškaraca (18-45 godina).
Other oral coumarins (e.g., phenprocoumon, acenocoumarol)
Drugi kumarinski lijekovi koji se uzimaju peroralno (npr. fenprokumon, acenokumarol)
Voriconazole Accord 200 mg film-coated tablets are supplied as white to off white, oval, approximately 15.6 mm in length and 7.8 mm in width, film-coated tablets, debossed with ‘V200' on one side and plain on the other side.
Voriconazole Accord 200 mg filmom obložene tablete su bijele do gotovo bijele, ovalne, filmom obložene tablete dužine otprilike 15,6 mm i širine otprilike 7,8 mm, s utisnutom oznakom "V200" na jednoj i bez oznake na suprotnoj strani.
In an independent published study, Alfentanil AUC0-∞  6fold.
Alfentanil AUC0-  6 puta
Efavirenz 300 mg QD, coadministered with voriconazole 400 mg BID*
Efavirenz 300 mg QD, primijenjeno istodobno s vorikonazolom u dozi od 400 mg BID*
Voriconazole Cmax and AUCτ
Vorikonazol Cmax i AUC ↔ Vorikonazol Cmax i AUC
[CYP2C9 substrates]
[supstrati CYP2C9]
If a patient develops a rash they should be monitored closely and Voriconazole Accord discontinued if lesions progress.
Ako se u bolesnika pojavi osip, treba ga pomno nadzirati te prekinuti primjenu lijeka Voriconazole Accord u slučaju progresije osipa.
Anticoagulants Warfarin (30 mg single dose, co- administered with 300 mg BID voriconazole)
Varfarin (jedna doza od 30 mg, primijenjena istodobno s vorikonazolom u dozi od 300 mg BID)
Plasma protein binding is estimated to be 58%.
Procjenjuje se da se na proteine plazme vezuje u omjeru od
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported with the use of voriconazole.
Prilikom primjene vorikonazola zabilježene su teške kožne nuspojave (engl. severe cutaneous adverse reactions, SCAR), uključujući Stevens-Johnsonov sindrom (SJS), toksičnu epidermalnu nekrolizu (TEN) i reakciju na lijek s eozinofilijom i sistemskim simptomima (engl. drug reaction with eosinophilia and systemic symptoms, DRESS).
300 mg TID (coadministered with voriconazole 400 mg single dose)
300 mg TID (primijenjeno istodobno s jednom dozom vorikonazola od 400 mg)
Voriconazole Cmax  69% Voriconazole AUCτ  78%
Vorikonazol Cmax  69% Vorikonazol AUC  78%
CARTON (Blister pack for 50 mg film-coated tablets - Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (Blister pakiranje za 50 mg filmom obložene tablete - pakiranje od 2, 10, 14, 20, 28, 30,
Eye disorders visual impairment6 retinal haemorrhage optic nerve disorder7, papilloedema8, oculogyric crisis, diplopia, scleritis, blepharitis optic atrophy, corneal opacity
krvarenje u retini poremećaj vidnog živca7, papiloedem8, okulogirična kriza, diplopija, skleritis, blefaritis atrofija vidnog živca, zamućenje rožnice
Voriconazole Cmax  34% Voriconazole AUCτ  39%
Vorikonazol Cmax  34% Vorikonazol AUC  39%
For patients with IA the overall rates of global response at 6 weeks were 64.3% (9/14), the global response rate was 40% (2/5)
Kod bolesnika s IA-om ukupne stope globalne reakcije nakon 6 tjedana bile su 64,3% (9/14), stopa globalne reakcije bila je 40% (2/5) za bolesnike u dobi od 2 do <12 godina i 77,8% (7/9) kod bolesnika u dobi od 12 do <18 godina.
Phenytoin may be coadministered with voriconazole if the maintenance dose of voriconazole is increased from 200 mg to 400 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see sections 4.4 and 4.5.
Fenitoin se smije primjenjivati istodobno s vorikonazolom ako se peroralna doza održavanja vorikonazola poveća s 200 mg na 400 mg dvaput na dan (sa 100 mg na 200 mg peroralno dvaput na dan u bolesnika s manje od 40 kg), vidjeti dijelove 4.4 i 4.5.
The predicted total exposures in children following IV maintenance doses of 4 and 8 mg/kg twice daily were comparable to those in adults following 3 and 4 mg/kg IV twice daily, respectively.
Predviđena ukupna izloženost u djece nakon intravenske primjene doze održavanja od 4 mg/kg dvaput na dan bila je usporediva s onom u odraslih nakon intravenske primjene 3 mg/kg dvaput na dan, dok je izloženost u djece nakon intravenske primjene doze od 8 mg/kg dvaput na dan bila usporediva s onom u odraslih nakon intravenske primjene doze od 4 mg/kg dvaput na dan.
squamous cell carcinoma
karcinom skvamoznih stanica*
Phenytoin may be co-administered with voriconazole if the maintenance dose of voriconazole is increased to 5 mg/kg IV BID or from 200 mg to 400 mg oral BID, (100 mg to 200 mg oral BID in patients less than 40 kg) (see section 4.2).
Fenitoin se može primjenjivati istodobno s vorikonazolom ako se doza održavanja vorikonazola povisi na 5 mg/kg BID intravenski, ili s 200 mg na 400 mg BID peroralno (sa 100 mg na 200 mg BID peroralno u bolesnika s manje od 40 kg) (vidjeti dio 4.2).
Voriconazole Cmax  4% Voriconazole AUCτ  32%
Vorikonazol Cmax  4% Vorikonazol AUC  32%
Voriconazole Cmax  49% Voriconazole AUCτ  69%
Vorikonazol Cmax  49% Vorikonazol AUC  69%
Other treated fungal infections (often with either 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,
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.