natgillin/translations-raw huggingface dataset:
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
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.