natgillin/translations-raw huggingface dataset:
Cardiac disorders arrhythmia supraventricular, tachycardia, bradycardia ventricular fibrillation, ventricular extrasystoles, ventricular tachycardia, electrocardiogram QT prolonged, supraventricular tachycardia torsades de pointes, atrioventricular block complete, bundle branch block, nodal rhythm 
Disturbi filqalb arritmija supraventrikolari, takikardja, bradikardja fibrillazzjoni ventrikolari, sistoli ventrikolari żejda, takikardja ventrikolari, elettrokardjogramm a QT imtawla, takikardja supraventrikolari torsades de pointes, interruzzjoni kompleta atrijoventrikulari, imblukkar filkumpartament tan-nervituri, ritmu nodali
While being treated with VFEND: 
Waqt li tkun qed tingħata kura b'VFEND:
5.2 Pharmacokinetic properties 
5.2 Tagħrif farmakokinetiku
However, a trend towards a higher frequency of liver enzyme elevations, reported as adverse events in clinical trials was observed in paediatric patients as compared to adults (14.2% transaminases increased in paediatrics compared to 5.3% in adults). 
Madankollu, andament lejn frekwenza ogħla ta' żidiet ta' enzimi fil-fwied, irrapportata bħala episodji avversi fil-provi kliniċi ġiet osservata f'pazjenti pedjatriċi meta mqabbla mal-adulti (żieda ta' 14.2% transaminases fit-tfal meta mqabbla ma' 5.3% fl-adulti).
Scedosporium and Fusarium infections Voriconazole was shown to be effective against the following rare fungal pathogens: 
Infezzjonijiet bi Scedosporium u Fusarium Voriconazole ntwera li kien effettiv kontra l-patoġeni fungali rari li ġejjin:
• The other ingredients are lactose monohydrate, pregelatinised starch, croscarmellose sodium, povidone and magnesium stearate which make up the tablet core and hypromellose, titanium dioxide (E171), lactose monohydrate and glycerol triacetate which make up the film-coat. 
• Is-sustanzi l-oħra huma lactose monohydrate, pregelatinised starch, croscarmellose sodium, povidone u magnesium stearate li jiffurmaw il-qalba tal-pillola u hypromellose, titanium dioxide (E171), lactose monohydrate u glycerol triacetate li jiffurmaw il-kisja tar-rita.
A measuring cup (graduated to indicate 23 ml), 5 ml oral syringe and a press-in bottle adaptor 
Kikkra tal-kejl (gradata biex tindika 23 ml), siringa orali ta' 5 ml u adapter press-in għall-flixkun
Repeat step 3 again. 
Irrepeti pass 3 mill-ġdid.
Each bottle contains 3 g of voriconazole. 
Kull flixkun fih 3 g voriconazole.
Medicinal product [Mechanism of interaction] 
Prodott Mediċinali [Mekkaniżmu ta' interazzjoni]
PVC / Aluminium/PVC/PVDC blister in cartons of 2, 10, 14, 20, 28, 30, 50, 56 or 100 film-coated tablets. 
Blister tal-PVC / Aluminium/PVC/PVDC f'pakketti ta' 2, 10, 14, 20, 28, 30, 50, 56 jew 100 pillola miksija b'rita.
• Benzodiazepines (e.g midazolam, triazolam) (used for severe insomnia and stress) 
• Benzodiazepines (e.ż., midazolam, triazolam) (użati għal nuqqas ta' rqad sever u stress)
The safety profile of voriconazole in adults is based on an integrated safety database of more than 2,000 subjects (including 1,603 adult patients in therapeutic trials) and an additional 270 adults in prophylaxis trials. 
Il-profil tas-sigurtà ta' voriconazole fl-adulti huwa bbażat fuq database integrata tas-sigurtà ta' aktar minn 2,000 suġġett (li jinkludu 1,603 pazjent adult f'testijiet terapewtiċi) u 270 adult addizzjonali filprovi dwar il-profilassi.
METHOD AND ROUTE(S) OF ADMINISTRATION 
>R (Reżistenti)
The major metabolite of voriconazole is the N-oxide, which accounts for 72% of the circulating radiolabelled metabolites in plasma. 
Il-metabolit prinċipali ta' voriconazole huwa l-ossidu N, li jammonta għal 72% tal-metaboliti radjutikkettati li jiċċirkolaw fil-plasma.
Solvent for solution for infusion: 
Soluzzjonijiet Kompatibbli għal Infużjoni:
For example, 15-20% of Asian populations may be expected to be poor metabolisers. 
Ngħidu aħna, 15-20 % tal-popolazzjonijiet Asjatiċi aktarx li jkunu metabolizzaturi ħżiena.
• Tacrolimus (used in transplant patients) 
• Tacrolimus (użat f'pazjenti tat-trapjanti)
During oral administration of 200 mg or 300 mg twice daily for 14 days in patients at risk of aspergillosis (mainly patients with malignant neoplasms of lymphatic or haematopoietic tissue), the observed pharmacokinetic characteristics of rapid and consistent absorption, accumulation and non-linear pharmacokinetics were in agreement with those observed in healthy subjects. 
Waqt amministrazzjoni orali ta' 200 mg jew 300 mg darbtejn kuljum għal 14-il jum f'pazjenti fil-periklu ta' asperġillosi (l-aktar pazjenti b'neoplażmi malinnji ta' tessut limfatiku jew haematopoietic), il-karatteristiċi farmakokinetiċi osservati ta' assorbiment rapidu u konsistenti, akkumulazzjoni u farmakokinetika mhux lineari kienu jaqblu ma' dawk osservati f'suġġetti b'saħħithom.
VFEND contains the active substance voriconazole. 
VFEND fih is-sustanza attiva voriconazole.
Lactose monohydrate Pregelatinised starch Croscarmellose sodium Povidone 
Qalba tal-pillola Lactose monohydrate Pregelatinised starch
VFEND 200 mg powder and solvent for solution for infusion Each 50 ml polypropylene bag contains sodium chloride 0.9% in Water for Injections. 
VFEND 200 mg trab u solvent għal soluzzjoni għall-infużjoni Kull borża tal-polypropylene ta' 50 ml fiha sodium chloride 0.9% f'Ilma għall-Injezzjonijiet.
Ritonavir (protease inhibitor) [potent CYP450 inducer; CYP3A4 inhibitor and substrate] 
Ritonavir (inibitur tal-protease ) [induttur qawwi ta' CYP450; inibitur u sustratt ta' CYP3A4]
In an oral multiple-dose study, AUCτ was similar in subjects with moderate hepatic cirrhosis (Child-Pugh B) given a maintenance dose of 100 mg twice daily and subjects with normal hepatic function given 200 mg twice daily. 
Fi studju ta' doża multipla orali, AUC kien simili f'suġġetti b'ċirrożi tal-fwied moderata (Child-Pugh B) mogħtija doża ta' manteniment ta' 100 mg darbtejn kuljum u suġġetti b'funzjoni normali tal-fwied mogħtija 200 mg darbtejn kuljum.
Each vial of VFEND contains 217.6 mg of sodium. 
Kull kunjett ta' VFEND fih 217.6 mg ta' sodju.
VFEND 200 mg film-coated tablets EU/1/02/212/013-024 
VFEND 200 mg pilloli miksijin b'rita EU/1/02/212/013-024
Ritonavir (potent CYP450 inducer; CYP3A4 inhibitor and substrate) Coadministration of voriconazole and low-dose ritonavir (100 mg twice daily) should be avoided unless an assessment of the benefit/risk to the patient justifies the use of voriconazole (see sections 4.3 and 4.5). 
Ritonavir (induttur qawwi ta' CYP450; inibitur u sustratt ta' CYP3A4) L-amministrazzjoni ta' voriconazole ma' doża baxxa ta' ritonavir (100 mg darbtejn kuljum) għandha tiġi evitata sakemm valutazzjoni tal-vantaġġ/riskju għall-pazjent ma tiġġustifikax l-użu ta' voriconazole (ara sezzjonijiet 4.3 u 4.5).
Methadone (CYP3A4 substrate) 
Methadone (sustratt CYP3A4)
Pharmacokinetic-Pharmacodynamic analyses of clinical trial data identified positive associations between plasma voriconazole concentrations and both liver function test abnormalities and visual disturbances. 
Analiżi farmakokinetiċi/farmakodinamiċi ta' dejta minn testijiet kliniċi identifikaw relazzjonijiet pożittivi bejn il-konċentrazzjonijiet ta' voriconazole fil-plasma u l-anormalitajiet fit-testijiet talfunzjoni tal-fwied u d-disturbi viżwali.
Oral Contraceptives [CYP3A4 substrate; CYP2C19 inhibitor] 
Kontraċettivi orali [sustratt ta' CYP3A4; inibitur ta' CYP2C19]
Other oral coumarins (e.g., phenprocoumon, acenocoumarol) [CYP2C9 and CYP3A4 substrates] 
phenprocoumon, acenocoumarol) [sustratti ta' CYP2C9 u CYP3A4]
Respiratory, thoracic and mediastinal disorders respiratory distress acute respiratory distress syndrome, pulmonary oedema 
Disturbi respiratorji, toraċiċi u medjastinali disturb respiratorju9
Step 3 
Punt 3
Powder for oral suspension: store at 2°C - 8°C (in a refrigerator) before constitution. 
Trab għal suspensjoni orali: aħżen f'temperatura ta' 2°C - 8°C (fi friġġ) qabel rikostituzzjoni.
Voriconazole is metabolised by, and inhibits the activity of, cytochrome P450 isoenzymes, CYP2C19, CYP2C9, and CYP3A4. 
Voriconazole huwa mmetabolizzat minn, u jinibixxi l-attività ta' l-isoenzimi taċ-ċitokromi P450, CYP2C19, CYP2C9, u CYP3A4.
50 ml infusion bag containing 0.9% of sodium chloride. 
Borża tal-infużjoni ta' 50 ml li fiha 0.9% ta' sodium chloride
Rifabutin (Potent CYP450 inducer) 
Rifabutin (Induttur qawwi ta' CYP450)
300 mg QD (coadministered with voriconazole 350 mg BID) 
300 mg QD (amministrat flimkien ma' voriconazole 350 mg BID)
Oral Suspension Patients 40 kg and above* 
Suspensjoni Orali Pazjenti li jiżnu 40 kg u aktar*
• Congenital or acquired QTc-prolongation. 
• Titwil konġenitu jew akkwiżit tal-QTc.
• Everolimus (used for treating advanced kidney cancer and in transplant patients) 
• Everolimus (użat għal trattament ta' kanċer avanzat fil-kliewi u f'pazjenti bi trapjanti).
Voriconazole (N=125) 
Punti aħħarin tal-istudju Voriconazole (N=125)
The median duration of study drug prophylaxis was 96 days for voriconazole and 68 days for itraconazole in the MITT group. 
Il-medjan tat-tul ta' żmien tal-profilassi bilmediċina tal-istudju kien ta' 96 jum għal voriconazole u 68 jum għal itraconazole fil-grupp MITT.
How to take VFEND 
'fih VFEND
EXP: 
Lott:
Prednisolone (60 mg single dose) [CYP3A4 substrate] 
Prednisolone (doża waħda ta' 60 mg) [sustratt ta' CYP3A4]
On the basis of the high oral bioavailability (96%; see section 5.2), switching between intravenous and oral administration is appropriate when clinically indicated. 
Fuq il-bażi tal-bijodisponibilità orali għolja (96%; ara sezzjoni 5.2), il-qalba bejn amministrazzjoni fil-vini u orali hija f'waqtha meta klinikament indikata.
Sirolimus (2 mg single dose) 
Sirolimus (doża waħda ta' 2 mg)
4 mg/kg twice daily 200 mg (5 ml) twice daily 
4 mg/kg darbtejn kuljum200 mg (5 ml) darbtejn kuljum
The MITT group included 40 patients with prior IFI, including 31 with aspergillosis, 5 with candidiasis, and 4 with other IFI. 
Il-grupp MITT kien jinkludi 40 pazjent b'IFIs filpassat, inklużi 31 b'asperġillosi , 5 b'candidiasis, u 4 b'IFI oħrajn.
EU/1/02/212/022 2 film-coated tablets EU/1/02/212/023 30 film-coated tablets EU/1/02/212/024 100 film-coated tablets 
EU/1/02/212/022 2 pilloli miksijin b'rita EU/1/02/212/023 30 pillola miksijin b'rita EU/1/02/212/024 100 pillola miksijin b'rita
A comparison of the paediatric and adult population pharmacokinetic data indicated that the predicted total exposure (AUC) in children following administration of a 9 mg/kg IV loading dose was comparable to that in adults following a 6 mg/kg IV loading dose. 
Paragun tad-dejta farmakokinetika fit-tfal u fl-adulti indika li l-esponiment totali (AUC) mbassar fittfal wara amministrazzjoni ta' doża inizjali fil-vina aktar qawwija ta' 9 mg/kg kien kumparabbli ma' dak tal-adulti wara amministrazzjoni ta' doża inizjali fil-vina aktar qawwija ta' 6 mg/kg.
The species most frequently involved in causing human infections include C. albicans, C. parapsilosis, C. tropicalis, C. glabrata and C. krusei, all of which usually exhibit minimal inhibitory concentration (MICs) of less than 1 mg/L for voriconazole. 
L-aktar speċi li spiss jikkawżaw infezzjonijiet tal-bniedem jinkludu C. albicans, C. parapsilosis, C. tropicalis, C. glabrata u C. krusei, li kollha normalment juru konċentrazzjoni inibitorja minima (MICs) ta' inqas minn 1 mg/L għal voriconazole.
PHARMACEUTICAL FORM AND CONTENTS 
GĦAMLA FARMAĊEWTIKA U KONTENUT
Powder for oral suspension White to off-white powder 
Trab għal suspensjoni orali Trab abjad għal offwajt
Omeprazole (40 mg QD) [CYP2C19 inhibitor; CYP2C19 and CYP3A4 substrate] 
Omeprazole (40 mg QD) [inibitur ta' CYP2C19 ; sustratt ta' CYP2C19 u CYP3A4]
Survived to day 180 
Baqgħu ħajjin sa jum 180
In clinical studies, response to voriconazole in patients with C. glabrata infections was 21% lower compared to C. albicans, C. parapsilosis and C. tropicalis. 
Fi studji kliniċi, ir-rispons għal voriconazole f'pazjenti b'infezzjonijiet ta' C. glabrata kien 21% inqas meta mqabbel ma' C. albicans, C. parapsilosis u C. tropicalis.
Use of standard doses of voriconazole with efavirenz doses of 400 mg QD or higher is contraindicated (see section 4.3). 
Użu ta' dożi standard ta' voriconazole ma' dożi ta' efavirenz 400mg QD jew aktar) huma kontraindikati (ara sezzjoni 4.3).
VFEND 200 mg powder for solution for infusion EU/1/02/212/025 
VFEND 200 mg trab għal soluzzjoni għall-infużjoni EU/1/02/212/025
VFEND 40 mg/ml powder for oral suspension voriconazole 
VFEND 40 mg/ml trab għal suspensjoni orali Voriconazole
VFEND 40 mg/ml powder for oral suspension Voriconazole 
VFEND 40 mg/ml trab għal suspensjoni orali voriconazole
After IV voriconazole therapy, the median duration of oral voriconazole therapy was 76 days (range 2-232 days). 
Wara trattament b'voriconazole IV it-trattament b'voriconazole orali dam għal-medja ta' 76 jum (medda ta' 2-232 jum).
EU/1/02/212/010 2 film-coated tablets EU/1/02/212/011 30 film-coated tablets EU/1/02/212/012 100 film-coated tablets 
EU/1/02/212/010 2 pilloli miksijin b'rita EU/1/02/212/011 30 pillola miksija b'rita EU/1/02/212/012 100 pillola miksija b'rita
Other HIV Protease Inhibitors (e.g., saquinavir, amprenavir and nelfinavir) [CYP3A4 substrates and inhibitors] 
Inibituri oħra tal-protease talHIV (e.ż., saquinavir, amprenavir u nelfinavir) [sustratti u inibituri ta' CYP3A4]
There have been reports of prolonged visual adverse reactions, including blurred vision, optic neuritis and papilloedema (see section 4.8). 
Kien hemm rapporti ta' episodji twal ta'reazzjonijiet avversi tal-vista, inklużi vista mċajpra, newrite ta' l-għajn u papilloedema (ara sezzjoni 4.8).
Coadministration with rifampicin, carbamazepine and phenobarbital since these medicinal products are likely to decrease plasma voriconazole concentrations significantly (see section 4.5). 
L-amministrazzjoni flimkien ma' rifampicin, carbamazepine u phenobarbital billi dawn il-prodotti mediċinali huma probabbli li jnaqqsu l-konċentrazzjonijiet ta' voriconazole fil-plasma b'mod sinifikanti (ara sezzjoni 4.5).
The volume of distribution at steady state for voriconazole is estimated to be 4.6 L/kg, suggesting extensive distribution into tissues. 
Il-volum tad-distribuzzjoni fiss għal voriconazole huwa stmat għal 4.6 L/kg, li jissuġġerixxi distribuzzjoni estensiva fit-tessuti.
Voriconazole was compared to itraconazole as primary prophylaxis in an open-label, comparative, multicenter study of adult and adolescent allogeneic HSCT recipients without prior proven or probable IFI. 
Voriconazole ġie mqabbel ma' itraconazole bħala profilassi primarja fi studju open-label, komparattiv, multiċentriku, ta' riċevituri adulti u adolexxenti alloġeniċi ta' HSCT mingħajr IFIs li ġew ikkonfermati jew li setgħu seħħew fil-passat.
Powder for solution for infusion: Sulfobutylether beta cyclodextrin sodium (SBECD) 
Trab għal soluzzjoni għall-infużjoni: Sulfobutylether beta cyclodextrin sodium (SBECD).
An updated RMP should be submitted: 
RMP aġġornat għandu jiġi ppreżentat:
In a secondary analysis, which utilised DRC assessments at the latest evaluable time point (EOT, or 2, 6, or 12 weeks after EOT) voriconazole and the regimen of amphotericin B followed by fluconazole had successful response rates of 65% and 71%, respectively. 
F'analiżi sekondarja, li użat valutazzjonijiet tad-DRC fl-aħħar punt taż-żmien valutabbli (EOT, 2, 6, jew 12-il ġimgħa wara l-EOT) voriconazole u l-iskema ta' amphotericin B segwit bi fluconazole kellhom rata ta' rispons ta' suċċess ta' 65% u 71%, rispettivament.
The safety of voriconazole was also investigated in 158 additional paediatric patients aged 2 to <12 years in compassionate use programs. 
Is-sigurtà ta' voriconazole ġiet investigata wkoll f'158 pazjent pedjatriku addizzjonali fl-etajiet ta' 2 sa <12-il sena fi programmi ta' użu ta' kompassjoni.
The terminal half-life of voriconazole depends on dose and is approximately 6 hours at 200 mg (orally). 
Il-half life terminali ta' voriconazole tiddependi fuq id-doża u hija madwar 6 sigħat b'doża ta' 200 mg (orali).
Excipient with known effect Each ml of suspension contains 0.54 g sucrose. 
Eċċipjent bl-effett magħruf Kull ml ta' suspensjoni fih 0.54 g ta' sucrose.
Carbamazepine and long-acting barbiturates (e.g., phenobarbital, mephobarbital) [potent CYP450 inducers] 
phenobarbital, mephobarbital) [indutturi qawwijin ta' CYP450]
Dose reduction of methadone may be needed (see section 4.5). 
Jista' jkun meħtieġ tnaqqis fiddoża ta' methadone (ara sezzjoni 4.5).
In an oral single-dose (200 mg) study in subjects with normal renal function and mild (creatinine clearance 41-60 ml/min) to severe (creatinine clearance <20 ml/min) renal impairment, the pharmacokinetics of voriconazole were not significantly affected by renal impairment. 
Fi studju ta' doża waħda orali (200 mg) f'suġġetti b'funzjoni normali tal-kliewi u indeboliment ħafif (tneħħija ta' krejatinina 41-60 ml/min) għal sever (tneħħija ta' krejatinina <20 ml/min) tal-kliewi, ilfarmakokinetika ta' voriconazole ma kinetx affettwata b'mod sinifikanti mill-indeboliment tal-kliewi.
Headache 
Dożaġġ
VFEND is also available as 50 mg and 200 mg film-coated tablets and 40 mg/ml powder for oral suspension. 
VFEND huwa disponibbli wkoll bħala pilloli ta' 50 mg u ta' 200 mg miksijin b'rita u 40 mg/ml trab għal suspensjoni orali.
When there is also a potential for voriconazole to increase the plasma concentrations of substances metabolised by CYP3A4 isoenzymes (certain antihistamines, quinidine, cisapride, pimozide), coadministration is contraindicated (see below and section 4.3). 
Meta ikun hemm ukoll potenzjal li voriconazole iżid il-konċentrazzjonijiet tas-sustanzi mmetabolizzati minn l-isoenzimi tal-CYP3A4 (ċertu antihistamines, quinidine, cisapride, pimozide), l-għoti flimkien ma' voriconazole huwa kontraindikat (ara hawn taħt u sezzjoni 4.3).
The primary mode of action of voriconazole is the inhibition of fungal cytochrome P450-mediated 14 alpha-lanosterol demethylation, an essential step in fungal ergosterol biosynthesis. 
Il-mod primarju ta' kif jaħdem voriconazole huwa billi jwaqqaf il-14 alpha-lanosterol demethylation medjata miċ-ċitokromu fungali P450, pass essenzjali fil-bijosintesi tal-ergosterol fungali.
Metabolism and nutrition disorders oedema peripheral hypoglycaemia, hypokalaemia, hyponatraemia 
Disturbi filmetaboliżmu u n-nutrizzjoni edema periferali ipogliċemija, ipokalimja, iponatremija
Undesirable effects reported in subjects receiving voriconazole: 
Effetti mhux mixtieqa rrapportati f'suġġetti li kienu qegħdin jingħataw voriconazole:
Gastrointestin al disorders diarrhoea, vomiting, abdominal pain, nausea cheilitis, dyspepsia, constipation, gingivitis peritonitis, pancreatitis, swollen tongue, duodenitis, gastroenteritis, glossitis 
Disturbi gastrointestinali dijarea, rimettar, uġigħ ta' żaqq, dardir kelite, dispepsja, kostipazzjoni, ġinġivite peritonite, pankreatite, ilsien minfuħ, duwodenite, gastroenterite, glossite
2 film-coated tablets 10 film-coated tablets 14 fim-coated tablets 20 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 100 film-coated tablets 
2 pilloli miksija b'rita 10 pilloli miksija b'rita 14-il pillola miksija b'rita 20 pillola miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 50 pillola miksija b'rita 56 pillola miksija b'rita 100 pillola miksija b'rita
Liver function tests 
Testijiet tal-funzjoni tal-fwied
VFEND oral suspension contains sucrose and should not be given to patients with rare hereditary problems of fructose intolerance, sucrase-isomaltase deficiency or glucose-galactose malabsorption. 
Is-suspensjoni orali VFEND fiha sucrose u m'għandhiex tingħata lil pazjenti bi problemi ereditarji rari ta' intolleranza għall-fructose, nuqqas ta' sucrase-isomaltase jew assorbiment ħażin tal-glucosegalactose.
• Quinidine (used for irregular heart beat) 
• Quinidine (użat għal taħbit tal-qalb irregolari)
• Carbamazepine (used to treat seizures) 
• Carbamazepine (użat għall-kura ta' attakki ta' puplesija )
Body Weight (kg) 
Piż talĠisem (kg)
1 ml of the constituted suspension contains 40 mg voriconazole. 
1 ml tas-suspensjoni kostitwita fih 40 mg ta' voriconazole.
PVC / Aluminium blister in cartons of 2, 10, 14, 20, 28, 30, 50, 56 or 100 film-coated tablets. 
Blister tal-PVC / Aluminium f'pakketti ta' 2, 10, 14, 20, 28, 30, 50, 56 jew 100 pillola miksija b'rita.
Cimetidine (400 mg BID) [non-specific CYP450 inhibitor and increases gastric pH] 
Cimetidine (400 mg BID) [inibitur mhux speċifiku ta' CYP450 u jżid il-pH fl-istonku]
1 sterile, single use, foil overwrapped, polypropylene bag containing VFEND solvent for solution for infusion in one compartment (50 ml). 
1 borża sterili tal-polypropylene, foil overwrapped, li tintuża darba biss, li jkun fiha VFEND solvent għal soluzzjoni għall-infużjoni f'kompartiment wieħed (50 ml).
Blood and lymphatic system disorders agranulocytosis pancytopenia, thrombocytopenia leukopenia, anaemia bone marrow failure, lymphadenopathy, eosinophilia disseminated intravascular coagulation 
Disturbi taddemm u tassistema limfatika agranuloċitożi panċitopenja, tromboċitopenja lewkopenja, anemija insuffiċjenza talmudullun, limfadenopatija, esinofilja koagulazzjoni intravaskulari mifruxa
2a Snap open Blue port. Bend the outer tube by 90° each way to ensure it is fully broken. 
90° kull naħa biex tkun ċert li tqaċċat kompletament.
The predicted total exposure in children following an oral maintenance dose of 9 mg/kg (maximum of 350 mg) twice daily was comparable to that in adults following 200 mg oral twice daily. 
L-esponiment totali mbassar fit-tfal wara doża ta' manteniment orali ta' 9 mg/kg (massimu ta' 350 mg) darbtejn kuljum kien kumparabbli ma' dak fl-adulti wara doża orali ta' 200 mg darbtejn kuljum.
Voriconazole also significantly increases efavirenz plasma concentrations (see section 4.5, for lower doses see section 4.4). 
Voriconazole ukoll jżid b'mod sinifikanti il-konċentrazzjonijiet ta' efavirenz fil-plasma (ara sezzjoni 4.5, għal dożi aktar baxxi ara sezzjoni 4.4).
VFEND 200 mg film-coated tablets White to off-white, capsule-shaped tablet, debossed “Pfizer” on one side and “VOR200”on the reverse. 
Pillola ta' kulur abjad għal offwajt, b'forma ta' kapsula, bi “Pfizer” imnaqqax fuq naħa u “VOR200” fuq in-naħa l-oħra.
Hepatic impairment After an oral single-dose (200 mg), AUC was 233% higher in subjects with mild to moderate hepatic cirrhosis (Child-Pugh A and B) compared with subjects with normal hepatic function. 
Wara doża waħda orali (200 mg), AUC kien 233% ogħla f'suġġetti b'ċirrożi tal-fwied ħafifa għal moderata (Child-Pugh A u B) meta mqabbel ma' pazjenti b'funzjoni normali tal-fwied.
In vitro studies showed that voriconazole is metabolised by the hepatic cytochrome P450 isoenzymes CYP2C19, CYP2C9 and CYP3A4. 
Studji in vitro wrew li voriconazole huwa metabolizzat mill-isoenzimi taċ-ċitokromu tal-fwied P450, CYP2C19, CYP2C9 U CYP3A4.
In patients with moderate to severe renal dysfunction (serum creatinine levels > 2.5 mg/dl), accumulation of the intravenous vehicle, SBECD, occurs (see sections 4.2 and 4.4). 
F'pazjenti b'disfunzjoni tal-kliewi moderata għal severa (livelli tal-kreatinina fis-serum > 2.5 mg /dl), isseħħ l-akkumulazzjoni tal-prodott mogħti ġol-vini, SBECD (ara sezzjonijiet 4.2 u 4.4).
Immune system disorders hypersensitivity anaphylactoid reaction 
Disturbi fissistema immuni sensittività eċċessiva reazzjoni anafilaktojdi
Blister pack for 50 mg film-coated tablets - Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100 
Pakkett folji għal pilloli ta' 5 mg miksijin b'rita - Pakkett ta' 2, 10, 14, 20, 28, 30, 50, 56, 100
VFEND 200 mg powder for solution for infusion and VFEND 200 mg powder and solvent for solution for infusion: 
VFEND 200 mg trab għal soluzzjoni għall-infużjoni u VFEND 200 mg trab u solvent għal soluzzjoni għall-infużjoni:
Rifabutin Cmax  195% Rifabutin AUC  331% Compared to voriconazole 200 mg BID, 
Rifabutin Cmax  195% Rifabutin AUC  331% Ikkumparat ma' 200 mg BID, Voriconazole Cmax  104% Voriconazole AUC  87%
Solvent for solution for infusion: Sodium chloride 0.9% in Water for Injections 
Solvent għal soluzzjoni għall-infużjoni: Sodium chloride 0.9% f'Ilma għall-Injezzjonijiet