natgillin/translations-raw huggingface dataset:
The direction of the arrow for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range. 
Id-direzzjoni tal-vleġġa għal kull parametru farmakokinetiku hija bbażata fuq livell ta' kunfidenza ta' 90% tal-medda ġeometrika medja fi ħdan (↔), taħt (↓) jew ‘il fuq (↑) mill-medda ta' 80-125%.
Oral suspension Patients 40 kg and above Patients less than 40 kg 
Suspensjoni orali Pazjenti li jiżnu 40 kg u aktar
A satisfactory global response (complete or partial resolution of all attributable symptoms, signs, radiographic/bronchoscopic abnormalities present at baseline) was seen in 53% of voriconazole-treated patients compared to 31% of patients treated with comparator. 
Intwera rispons globali sodisfaċenti (għajbien sħiħ jew parzjali tas-sinjali kollha tas-sintomi attribwibbli, anormalitajiet radjugrafiċi/bronkoskopiċi preżenti fil-linja bażi) fi 53% tal-pazjenti kkurati b'voriconazole meta mqabbel mal-31% tal-pazjenti kkurati bil-komparatur.
9 mg/kg dose (number of vials) 
doża ta' 9 mg/kg (numru ta' kunjetti)
Teenagers aged 12 to 14 years weighing 50 kg or more; and all teenagers older than 14 
Teenagers ta' bejn 12 u 14-il sena li jiżnu 50 kg jew aktar; u t-teenagers kollha ta' aktar minn 14il sena
Non-infectious periostitis with elevated fluoride and alkaline phosphatase levels has been reported in transplant patients. 
Kien hemm rapporti ta' perjostite (periostitis) mhux infettiva b'livelli ta' fluoride u alkaline phosphate għoljin f'pazjenti tat-trapjanti.
Not for bolus injection 
Mhux għal injezzjoni bolus
Risk Management Plan (RMP) 
• Pjan tal-ġestjoni tar-riskju (RMP)
Rifabutin [potent CYP450 inducer] 
Rifabutin (induttur qawwi ta' CYP450)
Side effects with frequency not known: Freckles and pigmented spots 
Effetti sekondarji bi frekwenza mhux magħrufa: - Nemex u tikek pigmentati
Interaction Geometric mean changes (%) 
Bdil fil-medja ġeometrika talinterazzjoni (%)
Proven or probable IFIs developed in 7.5% (3/40) of patients during the first year after HSCT, including one candidemia, one scedosporiosis (both relapses of prior IFI), and one zygomycosis. 
f'7.5% (3/40) tal-pazjenti matul l-ewwel sena wara HSCT, inklużi candidemijawaħda, xedosporjożi waħda (it-tnejn kienu irkaduti minn IFIs fil-passat), u żigomikożi waħda.
VFEND 200 mg powder and solvent for solution for infusion Powder for solution for infusion: White lyophilised powder. 
VFEND 200 mg trab u solvent għal soluzzjoni għall-infużjoni Trab għal soluzzjoni għall-infużjoni: Trab abjad ixxottat bil-friża.
All other adolescents (12 to 14 years and ≥50 kg; 15 to 17 years regardless of body weight) Voriconazole should be dosed as adults. 
Fl-adoloxxenti l-oħra kollha (12 sa 14-il sena u ≥50 kg; 15 sa 17-il sena irrispettivament mill-piż talġisem) id-doża ta' voriconazole għandha tkun bħal tal-adulti.
Excipient with known effect Each bag contains 177.02 mg sodium. 
Eċċipjent bl-effett magħruf Kull borża fiha 177.02 mg sodju.
VFEND 200 mg powder for solution for infusion: 
VFEND 200 mg trab għal soluzzjoni għall-infużjoni:
The studies included cerebral, sinus, pulmonary and disseminated aspergillosis in patients with bone marrow and solid organ transplants, haematological malignancies, cancer and AIDS. 
L-istudji kienu jinkludu asperġillosi ċerebrali, tas-sinus, pulmonari u mifruxa f'pazjenti bi trapjanti talmudullun u ta' organi solidi, tumuri ematoloġiċi, kanċer u AIDS.
• Pimozide (used for treating mental illness) 
• Pimozide (użat għall-kura ta' mard mentali)
A higher frequency of liver enzyme elevations was observed in the paediatric population (see section 4.8). 
Ġiet osservata frekwenza ogħla ta' żidiet ta' enzimi fil-fwied fil-popolazzjoni pedjatrika (ara sezzjoni 4.8).
Each tablet contains 50 mg voriconazole. 
Kull pillola fiha 50 mg ta' voriconazole.
Each tablet contains 50 or 200 mg voriconazole. 
Kull pillola fiha 50 jew 200 mg ta' voriconazole.
EXP Shelf life after reconstitution: 24 hours when stored at 2°C - 8°C. 
Żmien kemm idum tajjeb il-prodott wara rikostituzzjoni: 24 siegħa meta maħżun f'temperatura ta' 2C - 8C.
18.UNIQUE IDENTIFIER - HUMAN READABLE DATA 
IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
Reconstituted VFEND concentrate needs to be further diluted with sodium chloride (0.9%) infusion solution within the infusion bag before it is infused. 
Il-konċentrat ta' VFEND irrikostitwit irid jiġi dilwit aktar b'soluzzjoni għal infużjoni ta' sodium chloride (0.9%) fil-borża tal-infużjoni qabel ma jiġi infuż.
ANNEX II 
ANNESS II
VFEND 200 mg powder and solvent for solution for infusion: 
VFEND 200 mg trab u solvent għal soluzzjoni għall-infużjoni:
VFEND, is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: 
VFEND, huwa aġent antifungali triazole bi spettru wiesa' li huwa indikat fl-adulti u fit-tfal ta' sentejn jew aktar kif ġej:
Severe cutaneous adverse reactions (SCARs) such as 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. 
Reazzjonijiet avversi severi tal-ġilda (SCARs, severe cutaneous adverse reactions) bħal sindrome ta' Stevens-Johnson (SJS, Steven-Johnson syndrome), nekroliżi epidermika tossika (TEN, toxic epidermal necrolysis), u reazzjoni għall-mediċina b'sintomi ta' esinofilja u sistemiċi (DRESS, drug reaction with eosinophilia and systemic symptoms) li jistgħu jkunu ta' periklu għall-ħajja jew fatali, ġew irrappurtati bl-użu ta' voriconazole.
Hair loss 
Bijotrasformazzjoni
VFEND tablets contain lactose and should not be given to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. 
Il-pilloli VFEND fihom il-lattosju u m'għandhomx jingħataw lil pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew assorbiment ħażin tal-glukosju-galactose.
Each bottle contains 45 g of powder providing 70 ml of suspension when constituted with water as recommended. 
Kull flixkun fih 45 g trab li jipprovdu 70 ml ta' suspensjoni meta jiġu kostitwiti bl-ilma kif rakkomandat.
Voriconazole is rapidly and almost completely absorbed following oral administration, with maximum plasma concentrations (Cmax) achieved 1-2 hours after dosing. 
Voriconazole huwa assorbit malajr u kważi kompletament wara amministrazzjoni orali, b'konċentrazzjonijiet massimi fil-plasma (Cmax) jinkisbu siegħa sa sagħtejn wara d-doża.
: Successful response to voriconazole therapy was seen in 16 (6 complete, 10 partial responses) of 28 patients with S. apiospermum and in 2 (both partial responses) of 7 patients with S. prolificans infection. 
Scedosporium spp.: Rispons ta' suċċess għal terapija b'voriconazole kien muri f'16 (6 risponsi sħaħ, 10 parzjali) minn 28 pazjent b'infezzjoni ta' S. apiospermum u fi 2 (it-tnejn risponsi parzjali) minn 7 pazjenti b'infezzjoni ta' S. prolificans.
• candidaemia (another type of fungal infection due to Candida sp) in non-neutropenic patients (patients without abnormally low white blood cells count), 
• candidaemia (tip ieħor ta' infezzjoni fungali minħabba Candida sp) f'pazjenti li m'għandomx newtropenja (pazjenti li m'għandhomx għadd ta' ċelloli bojod tad-demm baxx mhux normali),
Reduction in the dose of alfentanil, fentanyl and other short-acting opiates similar in structure to alfentanil and metabolised by CYP3A4 (e.g., sufentanil) should be considered when coadministered with voriconazole (see section 4.5). 
Opiates li jaħdmu għal ħin qasir (sustratt CYP3A4) Tnaqqis fid-doża ta' alfentanil, fentanyl u opiates oħra li jaħdmu għal ħin qasir, bi struttura simili għal alfentanil u mmetabolizzati minn CYP3A4 (eż., sufentanil) għandhom ikunu kkunsidrati meta hemm amministrazzjoni flimkien ma voriconazole (ara sezzjoni 4.5).
In an oral multiple-dose study, Cmax and AUCτ for healthy young females were 83% and 113% higher, respectively, than in healthy young males (18-45 years). 
Fi studju ta' doża multipla orali, Cmax u AUC għal nisa żgħażagħ b'saħħithom kienu 83% u 113% ogħla, rispettivament, milli f'irġiel żgħażagħ b'saħħithom (18-45 sena).
8, drug reaction with eosinophilia and systemic symptoms (DRESS) angioedema, actinic keratosis*, pseudoporphyria , erythema multiforme, psoriasis, drug eruption cutaneous lupus erythemato sus*, ephelides*, lentigo* 
Disturbi filġilda u fittessuti ta' taħt il-ġilda raxx dermatite sfoljattiva, raxx makulari bl-infafet, ħakk, alopeċja, eritema sindromu ta' Stevens-Johnson fototossiċità, purpura, urtikarja, dermatite allerġika, raxx papulari, raxx makulari, ekżema nekroliżi epidermika tossika reazzjoni għallmediċina b'sintomi ta' esinofilja u sistemiċi (DRESS) anġjoedima, keratożi aktinika*, pseudoporphyria , eritema multiformi, psorjażi, eruzzjoni filġilda kull darba li tingħata doża lupus eritematożu s tal-ġilda *, nemex* u lentigo*
Reporting of suspected adverse reactions 
Rappurtar ta' reazzjonijiet avversi suspettati
6 mg/kg dose (number of vials) 
doża ta' 6 mg/kg (numru ta' kunjetti)
Infections and infestations sinusitis pseudomembranous colitis 
Infezzjonijiet u infestazzjoniji et sinusite kolite psewdomembranuż
Itchiness 
Anzjani
Four additional patients with fusariosis had an infection caused by several organisms; 2 of them had a successful outcome. 
Erba' pazjenti oħra b'fusariosis kellhom infezzjoni kkawżata minn diversi organiżmi; 2 minnhom kellhom eżitu ta' suċċess.
The inter-individual variability of voriconazole pharmacokinetics is high. 
Il-varjabilità tal-farmakokinetika ta' voriconazole bejn individwi differenti hija għolja.
Voriconazole N=224 
Punti tat-Tmiem tal-Istudju Voriconazole N=224
In clinical studies, response to voriconazole in C. krusei infections was similar to C. albicans, C. parapsilosis and C. tropicalis. 
Fi studji kliniċi, ir-rispons għal voriconazole f'infezzjonijiet ta' C. krusei kien simili għal dak ta' C. albicans, C. parapsilosis u C. tropicalis.
After reconstitution each ml contains 10 mg of voriconazole. 
Wara rikostituzzjoni, kull ml fih 10 mg ta' voriconazole.
VFEND 200 mg powder for solution for infusion voriconazole 
VFEND 200 mg trab għal soluzzjoni għal infużjoni Voriconazole
Each tablet contains either 50 mg voriconazole (for VFEND 50 mg film-coated tablets) or 200 mg voriconazole (for VFEND 200 mg film-coated tablets). 
Kull pillola fiha 50 mg (għal VFEND 50mg pilloli miksija b'rita) jew 200mg (għal VFEND 200mg pilloli miksija b'rita) ta' voriconazole.
For storage conditions after reconstitution of the medicinal product, see section 6.3. 
Dwar il-kondizzjonijiet għall-ħażna tal-prodott mediċinali wara r-rikostituzzjoni, ara sezzjoni 6.3.
Label on the vial 
Kartuna ta' barra
Fifty-three paediatric patients aged 2 to <18 years were treated with voriconazole in two prospective, openlabel, non-comparative, multi-center clinical trials. 
Tlieta u ħamsin pazjenti tfal ta' bejn is-sentejn u <18-il sena ġew ikkurati b'voriconazole f'żewġ provi kliniċi prospettivi, open-label, mhux komparattivi, multiċentriċi.
• The VFEND powder is reconstituted by using the specially marked syringe provided to remove 19 ml of VFEND solvent for solution for infusion (Sodium Chloride (0.9%) from the blue port of the infusion bag. 
• It-trab VFEND jiġi rikostitwit billi tintuża s-siringa mmarkata apposta pprovduta biex tneħħi 19 ml ta' VFEND solvent għal soluzzjoni għall-infużjoni (Sodium Chloride (0.9%) mill-port blu tal-borża tal-infużjoni.
• Exfoliative cutaneous reactions 
• Reazzjonijiet esfoljativi tal-ġilda
• It is recommended that a standard 20 ml (non-automated) syringe be used to ensure that the exact amount (19.0 ml) of Water for Injections or of 9 mg/ml (0.9%) Sodium Chloride for Infusion is dispensed. 
• Huwa rakkomandat li tintuża siringa standard ta' 20 ml (mhux awtomatika) sabiex jiġi żgurat li jingħata l-ammont eżatt (19.0 ml) ta' Ilma għall-Injezzjonijiet jew ta' 9 mg/ml (0.9%) Sodium Chloride għall-Infużjoni.
STATEMENT OF ACTIVE SUBSTANCE(S) 
DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
If phototoxic reactions occur multidisciplinary advice should be sought, VFEND discontinuation and use of alternative antifungal agents should be considered and the patient should be referred to a dermatologist. 
Jekk ikun hemm reazzjonijiet fototossiċi għandu jittieħed parir multidixxiplinari, it-twaqqif ta' VFEND u l-użu ta' mediċini antifungali alternattivi għandu jiġi kkunsidrat u l-pazjent għandu jintbagħat għand dermatologu.
The safety profile and plasma concentrations observed in male and female patients were similar. 
Il-profil tas-sigurtà u lkonċentrazzjonijiet fil-plasma osservati f'pazjenti rġiel u nisa kienu simili.
There is no known antidote to voriconazole. 
M'hemmx antidotu magħruf għal voriconazole.
VFEND 200 mg powder for solution for infusion Each vial contains 200 mg of voriconazole. 
VFEND 200 mg trab għal soluzzjoni għall-infużjoni Kull kunjett fih 200 mg ta' voriconazole.
Duration of treatment 
Trattament fit-tul
No clinically significant differences were seen when the safety data were analysed by age, race, or gender. 
Ebda differenzi klinikament sinifikanti ma kienu jidhru meta d-dejta tas-sigurtà ġiet analizzata skont l-età, razza jew sess.
• Once the syringe is reconnected to the blue port of the infusion bag, the contents are then emptied into the infusion bag from the syringe to provide a final voriconazole solution containing 0.5-5 mg/ml. 
• Ladarba s-siringa tkun tqabbdet mil-ġdid mal-port blu tal-borża tal-infużjoni, imbagħad ilkontenut jitbattal ġol-borża tal-infużjoni minn ġos-siringa sabiex jipprovdi soluzzjoni finali ta' voriconazole li jkun fiha 0.5-5 mg/ml.
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 class, are listed. 
Fit-tabella ta' hawn isfel, billi l-maġġoranza ta' l-istudji kienu ta' natura miftuħa, r-reazzjonijiet avversi kollha ta' kawżalità u l-kategoriji ta' frekwenza tagħhom f'1,873 adult minn studji terapewtiċi (1,603) u ta' profilassi (270) miġburin, skont is-sistema tal-klassifika tal-organi huma elenkati.
Cardiovascular 
Pożoloġija
Infuse at a maximum rate of 3 mg/kg per hour. 
Erħi b'rata massima ta' 3mg/kg fis-siegħa.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. 
Huwa importanti li jiġu rrappurtati reazzjonijiet avversi ssuspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
Rare: may affect up to 1 in 1000 people 
Rari: jistgħu jaffetwaw sa 1 kull 1,000 pazjent
In addition VFEND has been associated with phototoxicity including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria. 
Barra minn hekk VFEND kien assoċjat ma' fototossiċità, li tinkludi reazzjonijiet bħal nemex, lentigo, keratożi aktinika u pseudoporphyria.
Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients. 
Profilassi ta' infezzjonijiet fungali invażivi f'riċevituri alloġeniċi f'riskju għoli ta' trapjant ta' ċelluli imsejħa stem fid-demm (HSCT).
Photosensitivity reactions such as ephelides, lentigo and actinic keratosis have been reported, especially during long-term therapy (see section 4.4). 
Kienu rrapportati reazzjonijiet ta' fotosensittività bħal nemex, lentigo u keratożi aktinika, speċjalment waqt terapija fuq perjodu fit-tul (ara sezzjoni 4.4).
VFEND 50 mg film-coated tablets 
VFEND 50 mg pilloli miksijin b'rita
Coadministration with sirolimus since voriconazole is likely to increase plasma concentrations of sirolimus significantly (see section 4.5). 
L-amministrazzjoni flimkien ma' sirolimus billi voriconazole huwa probabbli li jżid ilkonċentrazzjonijiet fil-plasma ta' sirolimus b'mod sinifikanti (ara sezzjoni 4.5).
Rash 
Sess
Solvent for VFEND powder for solution for infusion Sodium Chloride 0.9% in Water for Injections Intravenous use 
Solvent għal VFEND trab għal soluzzjoni għall-infużjoni Sodium Chloride 0.9% fl-Ilma għall-Injezzjonijiet Użu ġol-vini
Dosage adjustment (Children [2 to <12 years] and young adolescents with low body weight [12 to 14 years and <50 kg]) 
Tfal (2 sa <12-il sena) u adoloxxenti żgħar li jiżnu inqas milli suppost (12 sa 14-il sena u <50 kg).
Renal and urinary disorders renal failure acute, haematuria renal tubular necrosis, proteinuria, nephritis 
Disturbi filkliewi u fissistema urinarja insuffiċjenza talkliewi akuta, ematurja nekrosi tubulari talkliewi, proteinurja, nefrite
Infusion-related reactions 
Reazzjonijiet relatati mal-infużjoni
VFEND 50 mg film-coated tablets voriconazole 
VFEND 50 mg pilloli miksijin b'rita voriconazole
Other proton pump inhibitors that are CYP2C19 substrates may also be inhibited by voriconazole and may result in increased plasma concentrations of these medicinal products. 
Inibituri oħra tal-proton pump li huma sustratti ta' CYP2C19 jistgħu wkoll jiġu inibiti minn voriconazole u jistgħu jirriżultaw f'żieda fillivelli ta' dawn il-prodotti mediċinali fil-plażma.
Infusion-related reactions, predominantly flushing and nausea, have been observed during administration of the intravenous formulation of voriconazole. 
Reazzjonijiet relatati ma' l-infużjoni, predominantament fwawar u dardir, ġew osservati matul amministrazzjoni tal-formolazzjoni ġol-vini ta' voriconazole.
Each tablet contains 200 mg voriconazole. 
Kull pillola fiha 200 mg ta' voriconazole.
• Cisapride (used for stomach problems) 
• Cisapride (użat għal problemi ta' l-istonku)
Visual impairments 
Indebolimenti viżwali
Currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made. 
Id-dejta disponibbli bħalissa hija deskritta f'sezzjoni 4.8 u 5.1, iżda ma tista' ssir l-ebda rakkomandazzjoni dwar il-pożoloġija.
200 mg (5 ml) every 12 hours 
200 mg (5 ml) darbtejn kuljum
It is recommended that a standard 20 ml (non-automated) syringe be used to ensure that the exact amount (19.0 ml) of water for injections or (9 mg/ml [0.9%]) Sodium Chloride for Infusion is dispensed. 
Huwa rakkomandat li tintuża siringa standard ta' 20 ml (mhux awtomatika) sabiex jiġi żgurat li jingħata l-ammont eżatt (19.0 ml) tal-ilma għall-injezzjonijiet jew (9 mg/ml [0.9%]) ta' Sodium Chloride għall-Infużjoni.
VFEND 200 mg film-coated tablets 
VFEND 200 mg pilloli miksijin b'rita
Although not studied clinically, voriconazole is likely to increase the plasma concentrations of statins that are metabolised by CYP3A4 and could lead to rhabdomyolysis. 
Għalkemm mhux studjat klinikament, voriconazole jista' jżid il-livelli tas-statins fil-plażma li huma metabolizzati minn CYP3A4 u jista' jwassal għal rhabdomyolysis.
1 sterile, single use vial adapter. 
1 adapter tal-kunjett sterili, li jintuża darba biss.
Long term exposure to voriconazole greater than 180 days (6 months) requires careful assessment of the benefit-risk balance (see sections 4.4 and 5.1). 
Esponiment fit-tul għal voriconazole li jkun aktar minn 180 jum (6 xhur) jeħtieġ evalwazzjoni b'attenzjoni tal-bilanċ benefiċċju-riskju (ara sezzjonijiet 4.4 u 5.1).
Eye disorders visual impairment retinal haemorrhage optic nerve disorder papilloedema oculogyric crisis, diplopia, scleritis, blepharitis optic atrophy, corneal opacity 
8, kriżi okuloġirika, tara doppju, sklerite, blefarite atrofija ottika, opaċità talkornea
• Oral contraceptives (if you take VFEND whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders) 
• Kontraċettivi orali (jekk tieħu VFEND waqt li tkun qed tuża kontraċettivi orali, jista' jkollok effetti mhux mixtieqa bħal dardir u disturbi mestrwali)
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). 
Dan l-istudju kkonferma sejbiet minn studju preċedenti, mfassal b'mod prospettiv fejn kien hemm eżitu pożittiv f'suġġetti b'fatturi ta' riskju għal pronjosi fqira, fosthom graft versus host disease, u b'mod partikolari, infezzjonijiet ċerebrali (normalment assoċjati ma' kważi 100% mortalità).
In a study in healthy volunteers investigating the impact of voriconazole on retinal function, voriconazole caused a decrease in the electroretinogram (ERG) waveform amplitude. 
Fi studju fost voluntiera b'saħħithom li eżamina l-impatt ta' voriconazole fuq il-funzjoni tarretina, voriconazole kkawża tnaqqis fl-electroretinogram (ERG) waveform amplitude.
Hepatobiliary disorders liver function test abnormal jaundice, jaundice cholestatic, hepatitis hepatic failure, hepatomegaly, cholecystitis, cholelithiasis 
Disturbi filfwied u filmarrara test tal-funzjoni tal-fwied b'riżultat anormali suffejra, suffejra kolestatika, epatite insuffiċjenza talfwied, epatomegalija, koleċistite, cholelithiasis
What VFEND contains -The active substance is voriconazole. 
'fih VFEND - Is-sustanza attiva hi voriconazole.
Bottle 
Kunjett
It is likely that these subjects may metabolize voriconazole more similarly to children than to adolescents/adults. 
Probabilment dawn il-suġġetti jimmetabolizzaw voriconazole b'mod aktar simili tat-tfal milli dak tal-adolexxenti/adulti.
Median duration of IV voriconazole therapy was 10 days (range 2-85 days). 
It-terapija b' voriconazole IV damet għal medja ta'għaxart ijiem (medda ta' 2-85 ġurnata).
This represents a heterogeneous population, containing patients with haematological malignancy, HIV-infected patients with oesophageal candidiasis and refractory fungal infections, non-neutropenic patients with candidaemia or aspergillosis and healthy volunteers. 
Din tirrappreżenta popolazzjoni eteroġenea, li tinkludi pazjenti b'tumuri ematoloġiċi, pazjenti infettati bl-HIV b'candidiasis esofagali u infezzjonijiet fungali refrettarji, pazjenti mhux newtropeniċi b'candidaemia jew asperġillosi u voluntiera b'saħħithom.
Intravenous Children aged 2 to less than 12 years and teenagers aged 12 to 14 years weighing less than 50 kg 
Tfal minn 2 sa anqas minn 12-il sena u teenagers ta' bejn 12 u 14-il sena li jiżnu anqas minn 50 kg
The effects on parturition are probably mediated by species-specific mechanisms, involving reduction of oestradiol levels, and are consistent with those observed with other azole antifungal agents. 
L-effetti fuq it-twelid probabbli huma medjati minn mekkaniżmi speċifiċi għall-ispeċi, li jinkludu t-tnaqqis tal-livelli ta' oestradiol, u huma konsistenti ma' dawk osservati b'aġenti antifungali oħra azoli.
The pharmacokinetics of voriconazole are non-linear due to saturation of its metabolism. 
Il-farmakokinetika ta' voriconazole mhix lineari minħabba s-saturazzjoni tal-metaboliżmu tiegħu.
Coadministration of voriconazole with everolimus is not recommended because voriconazole is expected to significantly increase everolimus concentrations (see section 4.4). 
Amministrazzjoni ta' voriconazole flimkien ma' everolimus mhuwiex irrakkomandat għaliex voriconazole huwa mistenni li jżid sinifikament ilkonċentrazzjonijiet ta' everolimus (ara sezzjoni 4.4).
Patients 40 kg and above* 
Orali Pazjenti li jiżnu 40 kg u aktar*
VFEND 200 mg film-coated tablets voriconazole 
VFEND 200 mg pilloli miksijin b'rita voriconazole
The absorption of voriconazole is not affected by changes in gastric pH. 
L-assorbiment ta' voriconazole mhux affettwat minn bidliet fil-pH gastriku.
- Reminds HCPs to discuss with the patient/care giver the risks of phototoxicity/skin SCC and hepatotoxicity, what to look for, how and when to seek immediate attention. 
- Ifakkar lil HCPs biex jiddiskutu mal-pazjent/il-persuna li tieħu ħsieb il-pazjent dwar irriskji ta' fototossiċità/SCC tal-ġilda u tossiċità tal-fwied, x'għandek tinnota, kif u meta tfittex attenzjoni immedjata.