natgillin/translations-raw huggingface dataset:
The overall incidence of transaminase increases >3 xULN (not necessarily comprising an adverse event) in the voriconazole clinical programme was 18.0% (319/1,768) in adults and 25.8% (73/283) in paediatric subjects who received voriconazole for pooled therapeutic and prophylaxis use. 
L-inċidenza globali ta' żidiet fit-transaminase >3 x ULN (mhux bilfors jinkludu episodju avvers) filprogramm kliniku b'voriconazole kienet 18.0% (319/1,768) fl-adulti u 25.8% (73/283) fil-pazjenti pedjatriċi li rċevew voriconazole għal użu terapewtiku u ta' profilassi miġbur.
Success at day 180* 
Suċċess f'jum 180*
Includes nuchal rigidity and tetany. 
Tinkludi riġidità nuċali u tetanija.
In vitro data showed a slight increase of resistance of C. glabrata to voriconazole. 
Data in vitro wriet żieda żgħira firreżistenzata' C. glabrata għal voriconazole.
Fluconazole (CYP2C9, CYP2C19 and CYP3A4 inhibitor) Coadministration of oral voriconazole and oral fluconazole resulted in a significant increase in Cmax and AUCτ of voriconazole in healthy subjects. 
Fluconazole (inibitur ta' CYP2C9, CYP2C19 u CYP3A4) Amministrazzjoni ta' voriconazole li jittieħed mill-ħalq flimkien ma' fluconazole li jittieħed mill-ħalq rriżulta f'żieda sinifikanti f'Cmax u AUCτ ta' voriconazole f'suġġetti b'saħħithom.
Renal adverse reactions 
Reazzjonijiet avversi tal-vista
EU/1/02/212/013 2 film-coated tablets EU/1/02/212/014 10 film-coated tablets EU/1/02/212/015 14 film-coated tablets EU/1/02/212/016 20 film-coated tablets EU/1/02/212/017 28 film-coated tablets EU/1/02/212/018 30 film-coated tablets EU/1/02/212/019 50 film-coated tablets EU/1/02/212/020 56 film-coated tablets EU/1/02/212/021 100 film-coated tablets EU/1/02/212/037 2 film-coated tablets EU/1/02/212/038 10 film-coated tablets EU/1/02/212/039 14 film-coated tablets EU/1/02/212/040 20 film-coated tablets EU/1/02/212/041 28 film-coated tablets EU/1/02/212/042 30 film-coated tablets EU/1/02/212/043 50 film-coated tablets EU/1/02/212/044 56 film-coated tablets EU/1/02/212/045 100 film-coated tablets 
EU/1/02/212/037 2 pilloli miksijin b'rita EU/1/02/212/038 10 pilloli miksijin b'rita EU/1/02/212/039 14-il pillola miksijin b'rita EU/1/02/212/040 20 pillola miksijin b'rita EU/1/02/212/041 28 pillola miksijin b'rita EU/1/02/212/042 30 pillola miksijin b'rita EU/1/02/212/043 50 pillola miksijin b'rita EU/1/02/212/044 56 pillola miksijin b'rita EU/1/02/212/045 100 pillola miksijin b'rita
Blister pack for 200 mg film-coated tablets - Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100 
Pakkett folji għal pilloli ta' 200 mg miksijin b'rita - Pakkett ta' 2, 10, 14, 20, 28, 30, 50, 56, 100
As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. 
Billi inti se tingħata din il-mediċina taħt sorveljanza medika mill-qrib, mhux probabbli li tfalli doża.
Dose reduction of alfentanil, fentanyl and other short-acting opiates similar in structure to alfentanil and metabolised by CYP3A4 (e.g., sufentanil) should be considered. 
Tnaqqis fid-doża ta' alfentanil, fentanyl u opiates oħra li jaħdmu fuq qasir żmien bi struttura simili għal alfentanil u metabolizzati minn CYP3A4 (e.ż., sufentanil) għandhom ikunu kkunsidrati.
• Sirolimus (used in transplant patients) 
• Sirolimus (użat f'pazjenti tat-trapjanti)
In clinical trials, visual impairments (including blurred vision, photophobia, chloropsia, chromatopsia, colour blindness, cyanopsia, eye disorder, halo vision, night blindness, oscillopsia, photopsia, scintillating scotoma, visual acuity reduced, visual brightness, visual field defect, vitreous floaters, and xanthopsia) with voriconazole were very common. 
Fi studji kliniċi, indebolimenti viżwali (inkluż vista mċajpra, fotofobija, kloropsija, kromatopsija, ma tarax il-kulur tajjeb, ċjanopsija, disturbi fl-għajnejn, tara raġġieri, ma tarax billejl, oxxillopsija, fotopsija, skotoma xintillanti, preċiżjoni viżiva mnaqqsa, luminożità viżiva, difett fil-kamp viżiv, tara frak fl-ilma tal-għajnejn, u xantopsija) b'voriconazole kienu komuni ħafna.
Monitoring for voriconazoleassociated adverse reactions is recommended if voriconazole is used sequentially after fluconazole (see section 4.5). 
Monitoraġġ ta' reazzjonijiet avversi assoċjati ma' voriconazole huwa rrakkomandat jekk voriconazole se jintuża wara fluconazole (ara sezzjoni 4.5).
However, as there were only 9 cases available for EUCAST analysis, there is currently insufficient evidence to set clinical breakpoints for C. krusei. 
Madankollu, peress li kien hemm biss 9 każ disponibbli għall-analiżi minn EUCAST, bħalissa m'hemmx evidenza biżżejjed biex jiġu stabbiliti breakpoints kliniċi għal C. krusei.
Psychiatric disorders depression, hallucination, anxiety, insomnia, agitation, confusional state 
Disturbi psikjatriċi depressjoni, alluċinazzjoni, ansjetà, nuqqas ta' rqad, aġitazzjoni, stat konfużjonali
Voriconazole has been shown to be more selective for fungal cytochrome P-450 enzymes than for various mammalian cytochrome P-450 enzyme systems. 
Kien muri li voriconazole huwa aktar selettiv għall-enzimi taċċitokromu fungali P450 milli għas-sistemi diversi taċ-ċitokromu fungali P450 tal-mammiferi.
3b Screw the syringe onto the vial adapter. 
3b Waħħal is-siringa ma' l-adatattur tal-kunjett.
Efavirenz 300 mg QD, coadministered with voriconazole 400 mg BID 
Efavirenz 300 mg QD, amministrazzjoni flimkien ma' voriconazole 400 mg BID
Paediatric population 
Popolazzjoni pedjatrika
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Ir-rekwiżiti tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
Duration of prophylaxis 
Tul ta' żmien tal-profilassi
The ERG measures electrical currents in the retina. 
L-ERG ikejjel il-kurrenti elettriċi fir-retina.
Blister foil for 200 mg film-coated tablets (all blister packs) 
Fojl tal-folji għal 200 mg pilloli miksijin b'rita (il-pakketti tal-folji kollha)
No subject experienced an interval exceeding the potentially clinically-relevant threshold of 500 msec. 
L-ebda suġġett ma esperjenza intervall li qabeż il-limitu potenzjalment klinikament rilevanti ta' 500 msec.
It may only be continued up to 180 days after transplantation in case of continuing immunosuppression or graft versus host disease (GvHD) (see section 5.1). 
Tista' titkompla biss għal sa 180 jum wara t-trapjant f'każ tattkomplija tal-immunosoppressjoni jew tal-graft versus host disease (GvHD) (ara sezzjoni 5.1).
Renal impairment 
Mhux irrakkomandat
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 VFEND (see section 4.4). 
reazzjonijiet avversi kutanji severi (SCARs, severe cutaneous adverse reactions), inkluż is-sindromu ta' Stevens-Johnson (SJS) (mhux komuni), nekroliżi epidermika tossika (TEN, toxic epidermal necrolysis) (rari), reazzjoni għall-mediċina b'sintomi ta' esinofilja u sistemiċi (DRESS) (rari) u eritema multiformi (rari) waqt kura b'VFEND (ara sezzjoni 4.4).
Each bag contains 50 ml of sodium chloride 0.9% in Water for Injections. 
Kull borża fiha 50 ml ta' sodium chloride 0.9% fl-Ilma tal-Injezzjonijiet.
Tabulated list of adverse reactions 
Lista f'tabella tar-reazzjonijiet avversi
Clinical studies examining QTc interval 
Studji kliniċi li eżaminaw l-Intervall QTc
VFEND 50 mg film-coated tablets White to off-white, round tablet, debossed “Pfizer” on one side and “VOR50”on the reverse. 
Pillola ta' kulur abjad għal offwajt, tonda, bi “Pfizer” imnaqqax fuq naħa u “VOR50” fuq in-naħa loħra.
EU/1/02/212/001 2 film-coated tablets EU/1/02/212/002 10 film-coated tablets EU/1/02/212/003 14 film-coated tablets EU/1/02/212/004 20 film-coated tablets EU/1/02/212/005 28 film-coated tablets EU/1/02/212/006 30 film-coated tablets EU/1/02/212/007 50 film-coated tablets EU/1/02/212/008 56 film-coated tablets EU/1/02/212/009 100 film-coated tablets EU/1/02/212/028 2 film-coated tablets EU/1/02/212/029 10 film-coated tablets EU/1/02/212/030 14 film-coated tablets EU/1/02/212/031 20 film-coated tablets EU/1/02/212/032 28 film-coated tablets EU/1/02/212/033 30 film-coated tablets EU/1/02/212/034 50 film-coated tablets EU/1/02/212/035 56 film-coated tablets EU/1/02/212/036 100 film-coated tablets 
EU/1/02/212/001 2 pilloli miksijin b'rita EU/1/02/212/002 10 pilloli miksija b'rita EU/1/02/212/003 14-il pillola miksija b'rita EU/1/02/212/004 20 pillola miksija b'rita EU/1/02/212/005 28 pillola miksija b'rita EU/1/02/212/006 30 pillola miksija b'rita EU/1/02/212/007 50 pillola miksija b'rita EU/1/02/212/008 56 pillola miksija b'rita EU/1/02/212/009 100 pillola miksija b'rita
8 mg/kg dose (number of vials) 
doża ta' 8 mg/kg (numru ta' kunjetti)
The most commonly reported adverse reactions were visual impairment, pyrexia, rash, vomiting, nausea, diarrhoea, headache, peripheral oedema, liver function test abnormal, respiratory distress and abdominal pain. 
L-aktar reazzjonijiet avversi rrapportati b'mod komuni kienu indeboliment fil-vista, deni, raxx, rimettar, dardir, dijarea, uġigħ ta' ras, edema periferali, riżultat anormali tat-test tal-funzjoni tal-fwied, problemi respiratorji u uġigħ ta' żaqq.
This metabolite has minimal antifungal activity and does not contribute to the overall efficacy of voriconazole. 
Dan il-metabolit għandu attività antifungali limitata u ma jikkontribwixxix għall-effikaċja globali ta' voriconazole.
Increased tacrolimus levels have been associated with nephrotoxicity. 
Livelli akbar ta' tacrolimus ġew assoċjati ma' nefrotossiċità.
• Efavirenz (used for treating HIV) in doses of 400 mg and above once daily 
• Efavirenz (użat għall-kura tal-HIV) f'dożi ta' 400 mg u aktar darba kuljum
An 8 mg/kg intravenous dose will provide voriconazole exposure approximately 2-fold higher than a 9 mg/kg oral dose. 
Doża fil-vina ta' 8 mg/kg ser tagħti esponiment ta' voriconazole ta' bejn wieħed u ieħor darbtejn aktar mid-doża orali ta' 9 mg/kg.
VFEND is also available as 50 mg and 200 mg film-coated tablets, 200 mg powder for solution for injection and 200 mg powder and solvent for solution for infusion. 
VFEND huwa disponibbli wkoll bħala pilloli ta' 50 mg u ta' 200 mg miksijin b'rita, 200 mg trab għal għall-injezzjoni u trab u solvent ta' 200 mg għal soluzzjoni għall-infużjoni.
Secondary Prophylaxis of IFI - Efficacy in HSCT recipients with prior proven or probable IFI Voriconazole was investigated as secondary prophylaxis in an open-label, non-comparative, multicenter study of adult allogeneic HSCT recipients with prior proven or probable IFI. 
Voriconazole ġie investigat bħala profilassi sekondarja fi studju open-label, mhux komparattiv, multiċentriku, ta' riċevituri adulti alloġeniċi ta' HSCT mingħajr IFIs li ġew ikkonfermati jew li setgħu seħħew fil-passat.
HDPE tablet containers containing 2, 30 or 100 film-coated tablets. 
Kontenituri tal-HDPE għall-pilloli li fihom 2, 30 jew 100 pillola miksija b'rita.
It is therefore recommended to use the oral suspension formulation in children aged 2 to <12. 
Għalhekk huwa rrakkomandat li tintuża l-formulazzjoni tas-suspensjoni orali fi tfal ta' 2 sa <12-il sena.
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). 
Id-doża ta' manteniment ta' voriconazole tista' tiżdied għal 5 mg/kg fil-vina BID jew minn 200 mg sa 350 mg b'mod orali BID, (100 mg sa 200 mg b'mod orali BID f'pazjenti li jiżnu anqas minn 40 kg) (ara sezzjoni 4.2).
In clinical trials, there have been cases of serious hepatic reactions during treatment with voriconazole (including clinical hepatitis, cholestasis and fulminant hepatic failure, including fatalities). 
Fi studji kliniċi, kien hemm każijiet ta' reazzjonijiet epatiċi waqt kura b'voriconazole (inkluż epatite klinika, kolestażi u insuffiċjenza tal-fwied f'daqqa, inkluż imwiet).
Increased ciclosporin levels have been associated with nephrotoxicity. 
Livelli akbar ta' ciclosporin ġew assoċjati ma' nefrotossiċità.
This enzyme exhibits genetic polymorphism. 
Dan l-enzim jippreżenta polimorfiżmu ġenetiku.
Coadministration of voriconazole and sirolimus is contraindicated (see section 
Amministrazzjoni ta' voriconazole flimkien ma' sirolimus huwa kontraindikat (ara sezzjoni 4.3).
• Indinavir and other HIV protease inhibitors (used for treating HIV) 
• Indinavir u inibituri oħra tal-protease ta' l-HIV (użati għall-kura ta' l-HIV)
• Not for administration as a bolus injection. 
• M'għandux jingħata bħala injezzjoni bolus.
Do not take VFEND: - If you are allergic to the active ingredient voriconazole, or to sulfobutylether beta cyclodextrin sodium 
Tiħux b'VFEND: - Jekk inti allerġiku għal sustanza attiva voriconazole, jew għal sulfobutylether beta cyclodextrin sodium (elenkati f'sezzjoni 6).
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. 
L-AUC, AUCt u AUC0- jirrapreżentaw l-arja ta' taħt il-kurva għal interval ta' dożaġġ, minn ħin zero sal-aħħar kejl kwantifikabbli u minn ħin zero sal-infinità, rispettivament.
Following constitution, the volume of the suspension is 75 ml, providing a usable volume of 70 ml. 
Wara li tiġi kostitwita, il-volum tas-suspensjoni jkun 75 ml, li jipprovdi volum użabbli ta' 70 ml.
After administration of a radiolabelled dose of voriconazole, approximately 80% of the radioactivity is recovered in the urine after multiple intravenous dosing and 83% in the urine after multiple oral dosing. 
Wara l-amministrazzjoni ta' doża radjutikkettata ta' voriconazole, madwar 80% tar-radjuattività tiġi rkuprata fl-awrina wara dożar multiplu fil-vini u 83% fl-awrina wara dożar multiplu orali.
IFI to day 100 
Suċċess f'jum 100
VFEND is also available as 200 mg powder for solution for infusion, 200 mg powder and solvent for solution for infusion and 40 mg/ml powder for oral suspension. 
VFEND huwa disponibbli wkoll bħala trab ta' 200 mg għal soluzzjoni għall-infużjoni, trab u solvent ta' 200 mg għal soluzzjoni għall-infużjoni u trab ta' 40 mg/ml għal suspensjoni orali.
• Oxycodone and other long-acting opiates such as hydrocodone (used for moderate to severe pain) 
• Oxycodone u opiates oħra li jaħdmu fuq tul ta' żmien bħal hydrocodone (użati kontra l-uġigħ moderat u sever)
Blister foil for 50 mg film-coated tablets (all blister packs) 
Fojl tal-folji għal 50 mg pilloli miksijin b'rita (il-pakketti tal-folji kollha)
Patients being treated with voriconazole are likely to be treated concomitantly with nephrotoxic medicinal products and have concurrent conditions that may result in decreased renal function (see section 4.8). 
Il-pazjenti li jkunu qed jiġu kkurati b'voriconazole huma probabbli li jiġu kkurati fl-istess waqt bi prodotti mediċinali nefrotossiċi u jkollhom kondizzjonijiet konkorrenti li jistgħu jwasslu għal funzjoni mnaqqsa tal-kliewi (ara sezzjoni 4.8).
1 single use 30 ml clear Type I glass vial with rubber stopper and aluminium cap with plastic seal of VFEND 200 mg, powder for solution. 
1 kunjett tal-ħġieġ ċar ta' 30 ml, ta' Tip I, li jintuża darba biss, b'tapp tal-lastku u għatu tal-aluminju b'siġill tal-plastik ta' VFEND 200 mg, trab għal soluzzjoni.
VFEND 50 mg film-coated tablets VFEND 200 mg film-coated tablets Voriconazole 
VFEND 50 mg pilloli miksijin b'rita VFEND 200 mg pilloli miksijin b'rita Voriconazole
Pharmacokinetics in special patient groups 
Farmakokinetika fi gruppi ta' pazjenti speċjali
8 mg/kg twice daily 
8 mg/kg darbtejn kuljum
• Health Care Professional (HCP) Checklist for Phototoxicity, SCC and Hepatic toxicity: - Reminds HCPs of the risks of phototoxicity, skin SCC and hepatotoxicity reported with voriconazole use. 
• Checklist tal-Professjonist fil-Qasam Mediku (HCP) għal Fototossiċità, SCC u Tossiċità talFwied
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. 
Lesponimenti totali mbassra fit-tfal wara dożi ta' manteniment fil-vina ta' 4 u 8 mg/kg darbtejn kuljum kienu kumparabbli ma' dawk tal-adulti wara dożi fil-vina ta' 3 u 4 mg/kg darbtejn kuljum, rispettivament.
VFEND must not be diluted with 4.2% Sodium Bicarbonate Infusion. 
VFEND m'għandux jiġi dilwit b'4.2% Infużjoni ta' Bikarbonat tas-Sodju.
The recommended doses in children and adolescent patients are based on a population pharmacokinetic analysis of data obtained from 112 immunocompromised paediatric patients aged 2 to <12 years and 26 immunocompromised adolescent patients aged 12 to <17 years. 
Id-dożi rrakkomandati fil-pazjenti tfal u adoloxxenti huma bbażati fuq analiżi farmakokinetika talpopolazzjoni ta' dejta miksuba minn 112 pazjenti immunokompromessi tfal fl-etajiet ta' 2 sa <12-il sena u 26 pazjenti adoloxxenti immunokompromessi fl-etajiet ta' 12 sa <17-il sena.
Depending on the severity of symptoms, consideration should be given to stopping treatment (see section 4.8). 
Jiddependi fuq is-severità tas-sintomi, għandha tingħata kunsiderazzjoni għat-twaqqif tat-trattament (ara sezzjoni 4.8).
Vial contains 200 mg of voriconazole. 
Kunjett fih 200 mg ta' voriconazole.
A relationship between plasma concentrations and age was observed. 
Kienet osservata relazzjoni bejn il-konċentrazzjonijiet fil-plasma u l-età.
300 mg QD (coadministered with voriconazole 400 mg BID) 
300 mg QD (amministrat flimkien ma' voriconazole 400 mg BID)
4 mg/kg twice daily 200 mg twice daily 100 mg twice daily 
4 mg/kg darbtejn kuljum200 mg darbtejn kuljum 100 mg darbtejn kuljum
BATCH NUMBER 
NUMRU TAL-LOTT
In vitro studies show that voriconazole may inhibit the metabolism of HIV protease inhibitors and the metabolism of voriconazole may also be inhibited by HIV protease inhibitors. 
Studji in vitro wrew li voriconazole jista' jwaqqaf il-metaboliżmu tal-inibituri tal-protease tal-HIV u lmetaboliżmu ta' voriconazole jista' wkoll jiġi mwaqqaf mill-inibituri tal-protease tal-HIV.
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. 
Barra minn hekk voriconazole juri attività fungiċida in vitro kontra patoġeni fungali emerġenti, fosthom dawk bħal Scedosporium jew Fusarium li għandhom suxxettibilità limitata għal aġenti antifungali eżistenti.
100 mg (2.5 ml) twice daily 
100 mg (2.5 ml) darbtejn kuljum
The powder is reconstituted with either 19 ml of water for injections or 19 ml of 9 mg/ml (0.9%) Sodium Chloride for Infusion to obtain an extractable volume of 20 ml of clear concentrate containing 10 mg/ml of voriconazole. 
It-trab huwa rikostitwit bi 19 ml tal- ilma għall-injezzjonijiet jew bi 19 ml ta' 9 mg/ml (0.9%) Sodium Chloride għall-Infużjoni sabiex jinkiseb volum li jista' jinġibed ta' 20 ml ta' konċentrat ċar li fih 10 mg/ml ta' voriconazole.
PHARMACEUTICAL PARTICULARS 
GĦAMLA FARMAĊEWTIKA
Coadministration with St. John's Wort (see section 4.5). 
John's wort (fexfiex) (ara sezzjoni 4.5).
400 mg (10 ml) every 12 200 mg (5 ml) every 12 
400 mg (10 ml) kull 12il siegħa
• Ritonavir (used for treating HIV) in doses of 100 mg twice daily 
• Ritonavir (użat għall-kura ta' l-HIV) f'dożi ta' 100 mg u aktar darbtejn kuljum
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). 
Fi studju ta' doża multipla orali l-Cmax u AUC f'irġiel anzjani b'saħħithom ( 65 sena) kienu 61% u 86% ogħla, rispettivament, milli f'irġiel żgħażagħ b'saħħithom (18-45 sena).
• Omeprazole (used for treating ulcers) 
• Omeprazole (użat għall-kura ta' l-ulċeri)
Includes drug-induced liver injury, hepatitis toxic, hepatocellular injury and hepatotoxicity. 
Tinkludi korriment tal-fwied ikkaġunat mill-mediċina, epatite tossika, korriment epatoċellulari u tossiċità talfwied.
• you are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome'. 
• jekk huwa magħruf li għandek kardjomijopatija, taħbit irregolari tal-qalb, taħbit tal-qalb bil-mod jew anormalità ta' l-elettrokardjogramma (ECG) imsejħa ‘sindromu tal-QTc twil'.
Other side effects 
Effetti sekondarji oħra
• Sinus bradycardia. 
Siringa waħda
Nine subjects in the voriconazole group and 5 in the amphotericin B followed by fluconazole group also had mycologically proven infection in deep tissue. 
Disa' suġġetti fil-grupp ta' voriconazole u 5 fil-grupp ta' amphotericin B segwit bi fluconazole wkoll kellhom infezzjoni ppruvata b'mod mikoloġiku fit-tessut fond.
Coadministration with ergot alkaloids (ergotamine, dihydroergotamine), which are CYP3A4 substrates, since increased plasma concentrations of these medicinal products can lead to ergotism (see section 4.5). 
L-amministrazzjoni flimkien ma' alkalojdi ta' l-ergotina (ergotamine, dihydroergotamine), li huma sustratti ta' CYP3A4, billi konċentrazzjonijiet akbar ta' dawn il-prodotti mediċinali fil-plasma jistgħu jwasslu għal ergotiżmu (ara sezzjoni 4.5).
The oral maintenance dose of 200 mg (or 100 mg for patients less than 40 kg) 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. 
Id-doża orali ta' manteniment ta' 300 mg (jew 150 mg għall-pazjenti li l-piż tagħhom huwa anqas minn 40 kg) twassal għal espożizzjoni simili għal dik ta' 4 mg/kg IV.
Nervous system disorders headache convulsion, syncope, tremor, hypertonia paraesthesia, somnolence, dizziness brain oedema, encephalopathy extrapyramidal disorder neuropathy peripheral, ataxia, hypoaesthesia, dysgeusia hepatic encephalopathy, Guillain-Barre syndrome, nystagmus 
Disturbi fissistema nervuża uġigħ ta' ras konvulżjoni, sinkope, rogħda, ipertonja parasteżija, ngħas, sturdament edima fil-moħħ, enċefalopatija 4, disturb ekstrapiramidali newropatija periferali, atassja, ipoestesija, tibdil fis-sens tat-togħma (dysgeusia)
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Sensittività eċċessiva għas-sustanza attiva jew għal xi eċċipjenti mniżżla f'sezzjoni 6.1.
Monitoring for voriconazole-associated adverse reactions is recommended if voriconazole is used sequentially after fluconazole. 
Monitoraġġ għal avvenimenti avversi assoċjati ma' voriconazole huwa rrakkomandat jekk voriconazole se jintuża wara fluconazole.
Phenytoin may be coadministered 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). 
Phenytoin jista' jingħata flimkien ma' voriconazole jekk id-doża ta' manteniment ta' voriconazole tiżdied għal 5 mg/kg fil-vina BID jew minn 200 mg sa 400 mg b'mod orali BID, (100 mg sa 200 mg b'mod orali BID f'pazjenti li jiżnu anqas minn 40 kg) (ara sezzjoni 4.2).
4 mg/kg dose (number of vials) 
doża ta' 4 mg/kg (numru ta' kunjetti)
In clinical trials there were 3 cases of accidental overdose. 
F'testijiet kliniċi kien hemm 3 każijiet ta' doża eċċessiva aċċidentali.
Frequent monitoring for adverse reactions and toxicity related to NSAIDs is recommended. 
Monitoraġġ frekwenti għal episodji avversi u tossiċità relatati ma' NSAIDs, huwa rrakkomandat.