natgillin/translations-raw huggingface dataset:
Why has IONSYS been approved? 
Zakaj je bilo zdravilo IONSYS odobreno?
When the patient activates IONSYS, a small electrical current moves a dose of fentanyl from the reservoir through the skin and into the bloodstream. 
Ko bolnik aktivira sistem IONSYS, električni tok premakne odmerek fentanila iz rezervoarja skozi kožo v krvni obtok.
The fentanyl is contained inside a reservoir. 
Fentanil se nahaja v rezervoarju.
However, the risk with IONSYS is low, as the medicine is for short-term use. 
Ker pa je zdravilo IONSYS indicirano za kratkotrajno uporabo, je tveganje majhno.
IONSYS is an iontophoretic transdermal system (ITS), which delivers the active substance, fentanyl hydrochloride, into the body through the skin. 
Zdravilo IONSYS je iontoforetični transdermalni sistem (ITS), ki skozi kožo v telo dovaja zdravilno učinkovino fentanilijev klorid.
IONSYS contain the active ingredient fentanyl, which is a strong painkiller. 
Zdravilo IONSYS vsebuje zdravilno učinkovino fentanil, ki je močno sredstvo za lajšanje bolečin.
IONSYS is used to control pain after an operation, in patients who are in hospital. 
Zdravilo IONSYS se uporablja za nadzor bolečine po operacijah in je namenjen samo uporabi v bolnišnicah.
The full EPAR for IONSYS can be found here. 
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo IONSYS je na voljo tukaj.
Fentanyl, the active substance in IONSYS, can be abused. 
Zdravilna učinkovina v zdravilu IONSYS je fentanil, ki ga je možno zlorabiti.
How has IONSYS been studied? 
Kako je bilo zdravilo IONSYS raziskano?
How does IONSYS work? 
Kako zdravilo IONSYS deluje?
What is IONSYS used for? 
Za kaj se zdravilo IONSYS uporablja?
What is IONSYS? 
Kaj je zdravilo IONSYS?
The fourth study compared IONSYS to morphine given by injection into a vein, and looked at the number of patients who judged their pain relief as ‘good' or ‘excellent'. 
V tej študiji so beležili število bolnikov, ki so stopnjo olajšanja bolečine označili kot „dobro“ ali „odlično“.
How is IONSYS used? 
Kako se zdravilo IONSYS uporablja?
1 bottle + 1 syringe + 1 bottle adapter 
1 plastenka + 1 brizga + 1 nastavek
20 mg/ml 
20 mg/ml peroralna raztopina
Date of first authorisation: 19 March 2002 Date of latest renewal: 21 February 2012 
Datum prve odobritve: 19. marec 2002 Datum zadnjega podaljšanja: 21. februar 2012
* This also applies to patients aged 15 years and older 
* To se nanaša tudi na bolnike, stare 15 let in več.
• you have had an allergic reaction to other azoles. 
• ste kdaj doživeli alergijsko reakcijo na druge azole.
Clinical experience Successful outcome in this section is defined as complete or partial response. 
Klinične izkušnje Uspešen izid je v tem delu opredeljen kot popoln ali delen odziv.
• Tablets must only be given if the child is able to swallow tablets. 
• Tablete se sme uporabiti le, če jih je otrok sposoben pogoltniti.
The asterisk (*) indicates a twoway interaction. 
Zvezdica (*) označuje dvosmerno interakcijo.
Do not stop treatment early because your infection may not be cured. 
Zdravljenja ne končajte predčasno, ker vaša okužba morda še ni ozdravljena.
You should always add a total of 46 ml of water irrespective of the dose you are taking. 
Vedno morate dodati vseh 46 ml vode, ne glede na odmerek, ki ga jemljete.
Repeat step 3 again. 
Ponovite 3. korak.
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.
Four additional patients with fusariosis had an infection caused by several organisms; 2 of them had a successful outcome. 
Dodatni štirje bolniki s fuzaridiozo so imeli okužbo, povzročeno z več organizmi; 2 od njih sta doživela uspešen izid.
• Existing symptomatic arrhythmias. 
• obstoječe simptomatske aritmije,
The syringe should be washed after each dose. 
Brizgo morate oprati po vsakem odmerku.
The following instructions apply to both Treatment and Prophylaxis 
Naslednja navodila veljajo tako za zdravljenje kot tudi za profilakso
While affected, do not drive or operate any tools or machines. 
Dokler to traja, ne smete voziti ali upravljati z orodji ali stroji.
Maximum increase in prothrombin time was approximately 2-fold. 
Največje podaljšanje protrombinskega časa je bilo približno 2-kratno.
It is important to take your VFEND tablets regularly at the same time each day. 
Pomembno je, da tablete VFEND jemljete redno, vsak dan ob istem času.
The contents of the infusion bag are now ready for infusion to the patient. 
Vsebina infuzijske vrečke je sedaj pripravljena za infundiranje bolniku.
It is important to take your VFEND suspension regularly at the same time each day. 
Pomembno je, da VFEND suspenzijo jemljete redno, vsak dan ob istem času.
Your treatment will be started as an infusion 
zdravljenje se bo začelo v obliki infuzije
Frequency categories are expressed as: Very common (1/10); Common (1/100 to 1/10); Uncommon (1/1,000 to 1/100); Rare (1/10,000 to 1/1,000); Very rare (1/10,000); Not known (cannot be estimated from the available data). 
Pogostnosti neželenih učinkov so opredeljene kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
• Sinus bradycardia. 
• sinusna bradikardija,
Each kit is for single use only. 
Vsak komplet je le za enkratno uporabo.
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 preskušancih z dejavniki tveganja za slabo prognozo, vključno z boleznijo presadka proti gostitelju in, še posebej, možganskimi okužbami (ki so običajno povezane s skoraj 100 % umrljivostjo).
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.
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.
Plasma protein binding is estimated to be 58%. 
Ocenjena vezava na beljakovine v plazmi je 58 %.
However tell your doctor or pharmacist if you think that a dose has been forgotten. 
Vendar zdravniku ali farmacevtu vseeno povejte, če se vam zdi, da je bil odmerek pozabljen.
Swallow the tablet whole with some water. 
Tableto pogoltnite celo, z nekaj vode.
Your doctor may change your dose depending on your condition. 
Vaš zdravnik lahko odmerek spremeni glede na vaše stanje.
What VFEND is and what it is used for 
Kaj je zdravilo VFEND in za kaj ga uporabljamo
Inspect the vial. 
Preglejte vialo.
Patients with a weakened immune system or those with difficult infections may require long-term treatment to prevent the infection from returning. 
Bolniki z oslabelim imunskim sistemom ali s težkimi okužbami bodo morda za preprečitev ponovitve okužbe potrebovali dolgotrajno zdravljenje.
Studies in animals have shown reproductive toxicity (see section 5.3). 
Študije na živalih so pokazale reprodukcijsko toksičnost (glejte poglavje 5.3).
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C. 
Kemična in fizikalna stabilnost med uporabo sta bili dokazani za 24 ur pri temperaturi med 2 °C in 8 °C.
3c Swirl the vial gently until all the powder is dissolved. 
3c Nežno sučite vialo, dokler se ves prašek ne raztopi.
See “Visual impairments” paragraph in section 4.8. 
Glejte odstavek "Okvare vida" v poglavju 4.8.
Treatment duration should be as short as possible; however, if based on the benefit-risk assessment the treatment is continued (see section 4.2), monitoring frequency can be reduced to monthly if there are no changes in the liver function tests. 
Trajanje zdravljenja mora biti čim krajše, če pa se na podlagi ocene koristi in tveganj zdravljenje nadaljuje (glejte poglavje 4.2), se lahko pogostost nadzora zmanjša na enkrat mesečno, če ni sprememb vrednosti testov jetrne funkcije.
Includes febrile neutropenia and neutropenia. 
Vključuje febrilno nevtropenijo in nevtropenijo.
If you forget to take one dose, take your next dose when it is due. 
Če pozabite vzeti en odmerek, vzemite naslednjega, ko je čas zanj.
VFEND must not be administered simultaneously with any blood product or any short-term infusion of concentrated solutions of electrolytes, even if the two infusions are running in separate lines. 
Zdravila VFEND se ne sme dajati sočasno s katerimkoli krvnim pripravkom ali s katerokoli kratkotrajno infuzijo koncentriranih raztopin elektrolitov, tudi če infuziji potekata po dveh ločenih linijah.
Treatment of serious fungal infections caused by Scedosporium spp. 
- zdravljenje hudih glivičnih okužb, ki jih povzročajo Scedosporium spp.
The suspension should not be further diluted with water or any other liquids. 
Pripravljene suspenzije ne redčite več z vodo ali katerokoli drugo tekočino.
Keep it in a clean safe place with the medicine. 
Hranite jo na suhem in varnem mestu skupaj z zdravilom.
Keep the container tighly closed. 
Vsebnik shranjujte tesno zaprt.
Add 46 ml of water and shake vigorously for about 1 minute. 
Dodajte 46 ml vode in močno stresajte približno 1 minuto.
Medicinal product [Mechanism of interaction] 
Zdravilo [mehanizem interakcije]
• For storage information, please refer to Section 5 ‘How to store VFEND'. 
• Glede informacij za shranjevanje glejte poglavje 5 "Shranjevanje zdravila VFEND".
Altered taste perception 
Spremenjeno zaznavanje okusa
The compatibility of VFEND with diluents other than listed above (or listed below under ‘Incompatibilities') is unknown. 
Združljivost zdravila VFEND z drugimi tekočinami razen zgoraj naštetih (ali omenjenih spodaj pod "Inkompatibilnosti") ni znana.
The infusion bag should be checked to ensure that the entire contents of the bag have been infused, especially if the same intravenous line is to be used for sequential infusion of other drugs. 
Infuzijsko vrečko je treba pregledati, da zagotovimo, da je bila infundirana vsa vsebina vrečke, še posebej, če bomo isti infuzijski sistem uporabili za zaporedno infundiranje drugih zdravil.
Bioequivalence between the powder for oral suspension and tablets has not been investigated in a paediatric population. 
Bioekvivalentnost praška za peroralno suspenzijo in tablet v pediatrični populaciji ni raziskana.
In vitro activity against the following pathogens has been shown, but the clinical significance is unknown: Curvularia spp. 
In vitro je bilo dokazano delovanje proti naslednjim patogenom, vendar klinični pomen tega ni znan: Curvularia spp.
It is recommended that your pharmacist constitutes VFEND suspension before giving it to you. 
Priporočljivo je, da vam vaš farmacevt pripravi zdravilo VFEND peroralna suspenzija, preden vam ga izroči.
The connected syringe and vial are then gently swirled to ensure that the VFEND powder has completely dissolved and no particulates are visible (do not shake). 
Spojeno brizgo in vialo nato nežno sučite, da zagotovite, da se je ves VFEND prašek popolnoma raztopil in ni prisotnih vidnih delcev (ne stresajte).
Hang the infusion bag. 
Obesite infuzijsko vrečko.
Pull the plunger out of the syringe and wash both parts in warm soapy water. 
Izvlecite bat iz brizge in operite oba dela z milnico v topli vodi.
This will force the medicine back into the bottle. 
Tako boste zdravilo potisnili nazaj v plastenko.
It is used for the treatment of patients (adults and children over the age of 2) with: 
Uporablja se za zdravljenje bolnikov (odraslih in otrok, starih 2 leti ali več):
Pregnancy There are no adequate data on the use of VFEND in pregnant women available. 
Nosečnost O uporabi zdravila VFEND pri nosečnicah ni na voljo dovolj podatkov.
On the basis of the high oral bioavailability (96%; see section 5.2), switching between intravenous and oral administration is appropriate when clinically indicated. 
Glede na veliko peroralno biološko uporabnost (96 %, glejte poglavje 5.2) je menjava med intravensko in peroralno uporabo primerna, če je klinično indicirana.
If particles are seen, swirl again and re-inspect. 
Če so vidni delci, jo ponovno sučite in preglejte.
7b Once the infusion delivery to the patient starts, do not manually squeeze the bag compartment as this may interfere with the dose delivery to the patient and may cause air ingress into the IV line. 
7b Ko se dostava infuzije bolniku prične, ne smete stiskati predelka vrečke, saj to lahko moti dostavo odmerka bolniku in lahko povzroči, da v i.v.
• Remove the bag of VFEND solvent for solution for infusion from the foil overwrap (do not use scissors or any other sharp tool). 
• Odstranite vrečko VFEND vehikla za raztopino za infundiranje iz ovoja (ne uporabite škarij ali kateregakoli drugega ostrega orodja).
Total parenteral nutrition: Total parenteral nutrition (TPN) need not be discontinued when prescribed with VFEND, but does need to be infused through a separate line. 
Popolna parenteralna prehrana: Pri predpisanem zdravilu VFEND ni potrebno prekiniti dajanja popolne parenteralne prehrane (TPN - total parenteral nutrition), vendar mora biti le-ta infundirana skozi ločeno linijo.
5b Empty the contents of the syringe into the bag. 
5b Izpraznite vsebino brizge v vrečko.
Candida species 
Vrsta Candida
Clinical management should include laboratory evaluation of hepatic function (specifically AST and ALT) at the initiation of treatment with VFEND and at least weekly for the first month of treatment. 
Klinična obravnava mora obsegati laboratorijsko oceno delovanja jeter (zlasti AST in ALT) na začetku zdravljenja z zdravilom VFEND in vsaj enkrat tedensko v prvem mesecu zdravljenja.
Other additives should not be introduced into the infusion bag. 
V infuzijsko vrečko ne smemo dodajati drugih aditivov.
Amphotericin B → fluconazole (N=122) 
amfotericin B → flukonazol (n = 122)
Scedosporium and Fusarium infections 
Okužbe s Scedosporium in Fusarium
The safety and efficacy of VFEND in children below 2 years has not been established. 
Varnost in učinkovitost zdravila VFEND pri otrocih, mlajših od 2 let, nista bili dokazani.
VFEND has moderate influence on the ability to drive and use machines. 
Zdravilo VFEND ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
Completed at least 100 days of study drug prophylaxis 
Zaključenih vsaj 100 dni profilakse s preiskovanim zdravilom
Considering the assumed limited gastroenteric transit time in paediatric patients, the absorption of tablets may be different in paediatric compared to adult patients. 
Upoštevaje domnevno omejeni gastro-enterični čas prehoda pri pediatričnih bolnikih je mogoče, da je absorpcija iz tablet pri pediatričnih bolnikih drugačna kot pri odraslih.
Infusion of total parenteral nutrition can occur simultaneously with VFEND but not in the same line or cannula. 
Sočasna infuzija popolne parenteralne prehrane z vorikonazolom je možna, vendar ne v isto linijo ali kanilo.
Infusions of blood products must not occur simultaneously with VFEND. 
Infuzije krvnih pripravkov se ne sme dajati hkrati z zdravilom VFEND.
Do not administer to the patient as a bolus injection. 
Ne dajajte bolnikom kot bolusno injekcijo.
Therefore, from a microbiological point of view, once solvent has been removed from the bag to reconstitute the VFEND powder for solution for infusion and then reintroduced into the bag, the product must be used immediately. 
Zato je z mikrobiološkega vidika po odvzetju vehikla iz vrečke, rekonstituiranju VFEND praška za raztopino za infundiranje in ponovni uvedbi zdravila v vrečko, zdravilo treba uporabiti takoj.
VFEND must not be infused into the same line or cannula concomitantly with other drug infusions, including parenteral nutrition (e.g., Aminofusin 10% Plus). 
Zdravila VFEND se ne sme infundirati v isto linijo ali kanilo sočasno z infundiranjem drugih zdravil, vključno s parenteralno prehrano (npr. Aminofusin 10 % Plus).
Following constitution, the total volume of the suspension must be 75 ml. 
Skupni volumen suspenzije po pripravi mora biti 75 ml.
When the VFEND infusion is complete, the line may be used for administration of other intravenous products. 
Ko je infuzija zdravila VFEND končana, se lahko linija uporabi za dajanje drugih intravenskih pripravkov.
It is recommended that all patients, including children, avoid exposure to direct sunlight during VFEND treatment and use measures such as protective clothing and sunscreen with high sun protection factor (SPF). 
Priporočljivo je, da se vsi bolniki, vključno z otroci, med zdravljenjem z zdravilom VFEND izogibajo izpostavljenosti neposredni sončni svetlobi in sledijo ukrepom, kot so zaščitna oblačila in krema za zaščito pred soncem z visokim zaščitnim faktorjem.
If VFEND is continued, however, dermatologic evaluation should be performed on a systematic and regular basis, to allow early detection and management of premalignant lesions. 
Če pa se zdravljenje z zdravilom VFEND nadaljuje, je treba bolnike redno in sistematično dermatološko ocenjevati, da se omogoči zgodnje odkrivanje in obravnavanje predrakavih lezij.
• Cardiomyopathy, in particular when heart failure is present. 
• kardiomiopatija, posebej ob prisotnem popuščanju srca,
VFEND suspension should not be mixed with any other medicine. 
VFEND peroralne suspenzije ne smete mešati z nobenim drugim zdravilom.
• The syringe may then be removed and the contents of the infusion bag mixed gently by inverting the bag several times. 
• Brizgo lahko nato odstranite, vsebino infuzijske vrečke pa nežno premešajte tako, da vrečko večkrat zasučete.
• candidaemia (another type of fungal infection due to Candida sp) in non-neutropenic patients (patients without abnormally low white blood cells count), 
• s kandidemijo (druga vrsta glivične okužbe, ki jo povzročajo vrste Candida) pri nenevtropeničnih bolnikih (bolniki, ki nimajo nenormalno zmanjšanega števila belih krvnih celic),
Children and adolescents VFEND should not be given to children younger than 2 years of age. 
Zdravila VFEND ne smejo dobiti otroci, mlajši od 2 let.
Women of child-bearing potential Women of child-bearing potential must always use effective contraception during treatment. 
Ženske v rodni dobi Ženske v rodni dobi morajo med zdravljenjem vedno uporabljati učinkovito kontracepcijo.
• Serious dermatological adverse reactions (including SCC) The frequency of phototoxicity reactions is higher in the paediatric population. 
• Resni dermatološki neželeni učinki (vključno s ploščatoceličnim karcinomom) Pri pediatrični populaciji je pogostnost fototoksičnih reakcij večja.
Manufacturer Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France. 
Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, Francija
VFEND may cause blurring of vision or uncomfortable sensitivity to light. 
Zdravilo VFEND lahko povzroči zamegljen vid ali neprijetno občutljivost na svetlobo.
Your pharmacist should advise you how to measure the medicine using the multi-dosing oral syringe provided in the pack. 
Vaš farmacevt vam bo svetoval, kako odmeriti zdravilo s pomočjo večodmerne peroralne brizge, ki je priložena v škatli.
Patients, especially children, with risk factors for acute pancreatitis (e.g., recent chemotherapy, haematopoietic stem cell transplantation [HSCT]), should be monitored closely during VFEND treatment. 
Bolnike, še posebej otroke, z dejavniki tveganja za akutni pankreatitis (npr. nedavna kemoterapija, presaditev matičnih krvotvornih celic [HSCT - Haematopoietic Stem Cell Transplantation]) je treba med zdravljenjem z zdravilom VFEND skrbno nadzorovati.
The bag should be carefully inspected to ensure that there are no particulates. 
Vrečko je treba pozorno pregledati, da zagotovimo, da ni prisotnih vidnih delcev.
If you have liver disease, your doctor may prescribe a lower dose of VFEND. 
Če imate bolezen jeter, vam bo vaš zdravnik morda predpisal manjši odmerek zdravila VFEND.
In the primary analysis, successful response as assessed by a Data Review Committee (DRC) blinded to study medicinal product was defined as resolution/improvement in all clinical signs and symptoms of infection with eradication of Candida from blood and infected deep tissue sites 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).
The effect of voriconazole on either erythromycin or azithromycin is unknown. 
Učinek vorikonazola na eritromicin ali azitromicin ni znan.
• you are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome'. 
• imate kardiomiopatijo, nereden srčni utrip, upočasnjeno bitje srca ali nepravilnost v elektrokardiogramu (EKG), imenovano »sindrom dolgega intervala QTc«.
Store in a refrigerator (2°C - 8°C). 
Shranjujte v hladilniku (2 ˚C - 8 ˚C).
AUC, 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. 
AUC, AUCt in AUC0- predstavljajo površino pod krivuljo preko odmernega intervala, površino pod krivuljo od časa nič do časa detekcije in površino pod krivuljo od časa nič do neskončnosti.
Powder for oral suspension 45 g 
prašek za peroralno suspenzijo 45 g
For Caucasians and Blacks the prevalence of poor metabolisers is 3-5%. 
Med belci in črnci je prevalenca oseb z zmanjšano presnovo 3-5 %.
If any particles are seen, discard the infusion bag. 
Če so vidni delci, infuzijsko vrečko zavrzite.
To measure the dose accurately, the top edge of the black ring should be lined up with the graduated mark on the oral syringe. 
Da boste odmerili točen odmerek, mora biti zgornji rob črnega prstana poravnan z oznako vašega odmerka na peroralni brizgi.
The majority of rashes were of mild to moderate severity. 
Večina izpuščajev je bila blagih do zmerno izrazitih.
(Maintenance Dose) 
(vzdrževalni odmerek)
If you take more suspension than prescribed (or if someone else takes your suspension) you must seek medical advice or go to the nearest hospital casualty department immediately. 
Če vzamete več suspenzije, kot je predpisano (ali če kdo drug vzame vašo suspenzijo), morate takoj poiskati zdravniški nasvet ali se takoj zglasiti v ambulanti za nujno pomoč najbližje bolnišnice.
In the combined data from three bioequivalence studies using the powder for oral suspension formulation, treatment-related taste perversion was recorded in 12 (14%) of subjects. 
V kombiniranih podatkih iz treh bioekvivalenčnih študij, kjer so uporabljali prašek za peroralno suspenzijo, so pri 12 osebah (14%) zabeležili spremenjeno zaznavanje okusa, povezano z zdravljenjem.
These oral dose recommendations for children are based on studies in which voriconazole was administered as the powder for oral suspension. 
Ta priporočila o peroralnem odmerjanju pri otrocih temeljijo na študijah, v katerih so vorikonazol uporabljali v obliki praška za peroralno suspenzijo.
The compatibility of voriconazole with diluents other than described above or in section 6.2 is unknown. 
Združljivost vorikonazola z drugimi redčili razen tistih, navedenih zgoraj oz. v poglavju 6.2, ni znana.
• you are suffering from, or have ever suffered from liver disease. 
• imate ali ste v preteklosti imeli bolezen jeter.
Voriconazole has been associated with QTc interval prolongation. 
Vorikonazol je bil povezan s podaljšanjem intervala QTc.
Safety and effectiveness in paediatric subjects below the age of two years has not been established (see sections 4.8 and 5.1). 
Varnost in učinkovitost pri pediatričnih preskušancih, mlajših od dveh let, nista bili dokazani (glejte poglavji 4.8 in 5.1).