FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Maltese: 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.
English: 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.
Maltese: 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.
English: VFEND is also available as 50 mg and 200 mg film-coated tablets and 40 mg/ml powder for oral suspension.
Maltese: VFEND huwa disponibbli wkoll bħala pilloli ta' 50 mg u ta' 200 mg miksijin b'rita u 40 mg/ml trab għal suspensjoni orali.
English: 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).
Maltese: 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).
English: 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.
Maltese: 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.
English: Undesirable effects reported in subjects receiving voriconazole:
Maltese: Effetti mhux mixtieqa rrapportati f'suġġetti li kienu qegħdin jingħataw voriconazole:
English: 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
Maltese: 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
English: including A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans; Candida spp., including C. albicans, C. glabrata, C. krusei, C. parapsilosis and C. tropicalis; and limited numbers of C. dubliniensis, C. inconspicua, and C. guilliermondii, Scedosporium spp., including S. apiospermum, S. prolificans; and Fusarium spp.
Maltese: Tropicalis; u ammonti limitati ta' C. dubliniensis, C. inconspicua, u C. guilliermondii, Scedosporium spp., fosthom S. apiospermum, S. prolificans u Fusarium spp.
English: 2a Snap open Blue port. Bend the outer tube by 90° each way to ensure it is fully broken.
Maltese: 90° kull naħa biex tkun ċert li tqaċċat kompletament.
English: Includes nuchal rigidity and tetany.
Maltese: Tinkludi riġidità nuċali u tetanija.
English: Cimetidine (400 mg BID) [non-specific CYP450 inhibitor and increases gastric pH]
Maltese: Cimetidine (400 mg BID) [inibitur mhux speċifiku ta' CYP450 u jżid il-pH fl-istonku]
English: Body Weight (kg)
Maltese: Piż talĠisem (kg)
English: 1 ml of the constituted suspension contains 40 mg voriconazole.
Maltese: 1 ml tas-suspensjoni kostitwita fih 40 mg ta' voriconazole.
English: PVC / Aluminium blister in cartons of 2, 10, 14, 20, 28, 30, 50, 56 or 100 film-coated tablets.
Maltese: Blister tal-PVC / Aluminium f'pakketti ta' 2, 10, 14, 20, 28, 30, 50, 56 jew 100 pillola miksija b'rita.
English: Blood and lymphatic system disorders agranulocytosis pancytopenia, thrombocytopenia leukopenia, anaemia bone marrow failure, lymphadenopathy, eosinophilia disseminated intravascular coagulation
Maltese: Disturbi taddemm u tassistema limfatika agranuloċitożi panċitopenja, tromboċitopenja lewkopenja, anemija insuffiċjenza talmudullun, limfadenopatija, esinofilja koagulazzjoni intravaskulari mifruxa
English: 1 sterile, single use, foil overwrapped, polypropylene bag containing VFEND solvent for solution for infusion in one compartment (50 ml).
Maltese: 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).
English: VFEND 200 mg film-coated tablets White to off-white, capsule-shaped tablet, debossed “Pfizer” on one side and “VOR200”on the reverse.
Maltese: Pillola ta' kulur abjad għal offwajt, b'forma ta' kapsula, bi “Pfizer” imnaqqax fuq naħa u “VOR200” fuq in-naħa l-oħra.
English: 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.
Maltese: 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.
English: In vitro studies showed that voriconazole is metabolised by the hepatic cytochrome P450 isoenzymes CYP2C19, CYP2C9 and CYP3A4.
Maltese: Studji in vitro wrew li voriconazole huwa metabolizzat mill-isoenzimi taċ-ċitokromu tal-fwied P450, CYP2C19, CYP2C9 U CYP3A4.
English: 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.
Maltese: 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.
English: 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
Maltese: 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
English: 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).
Maltese: 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).
English: Blister pack for 50 mg film-coated tablets - Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100
Maltese: Pakkett folji għal pilloli ta' 5 mg miksijin b'rita - Pakkett ta' 2, 10, 14, 20, 28, 30, 50, 56, 100
English: VFEND 200 mg powder for solution for infusion and VFEND 200 mg powder and solvent for solution for infusion:
Maltese: VFEND 200 mg trab għal soluzzjoni għall-infużjoni u VFEND 200 mg trab u solvent għal soluzzjoni għall-infużjoni:
English: Rifabutin Cmax  195% Rifabutin AUC  331% Compared to voriconazole 200 mg BID,
Maltese: Rifabutin Cmax  195% Rifabutin AUC  331% Ikkumparat ma' 200 mg BID, Voriconazole Cmax  104% Voriconazole AUC  87%
English: Solvent for solution for infusion: Sodium chloride 0.9% in Water for Injections
Maltese: Solvent għal soluzzjoni għall-infużjoni: Sodium chloride 0.9% f'Ilma għall-Injezzjonijiet
English: In vitro data showed a slight increase of resistance of C. glabrata to voriconazole.
Maltese: Data in vitro wriet żieda żgħira firreżistenzata' C. glabrata għal voriconazole.
English: 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.
Maltese: 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.
English: Blister pack for 200 mg film-coated tablets - Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100
Maltese: Pakkett folji għal pilloli ta' 200 mg miksijin b'rita - Pakkett ta' 2, 10, 14, 20, 28, 30, 50, 56, 100
English: 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.
Maltese: 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.
English: Monitoring for voriconazoleassociated adverse reactions is recommended if voriconazole is used sequentially after fluconazole (see section 4.5).
Maltese: Monitoraġġ ta' reazzjonijiet avversi assoċjati ma' voriconazole huwa rrakkomandat jekk voriconazole se jintuża wara fluconazole (ara Sezzjoni 4.5).
English: 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).
Maltese: 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).
English: Compared to efavirenz 600 mg QD, Efavirenz Cmax ↔ Efavirenz AUC  17%
Maltese: Efavirenz Cmax ↔ Efavirenz AUC  17%
English: 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).
Maltese: Il-pazjenti żviluppaw 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).
English: Voriconazole has been shown to be more selective for fungal cytochrome P-450 enzymes than for various mammalian cytochrome P-450 enzyme systems.
Maltese: Kien muri li voriconazole huwa aktar selettiv għall-enzimi taċċitokromu fungali P450 milli għas-sistemi diversi taċ-ċitokromu fungali P450 tal-mammiferi.
English: 3b Screw the syringe onto the vial adapter.
Maltese: 3b Waħħal is-siringa ma' l-adatattur tal-kunjett.
English: Efavirenz 300 mg QD, coadministered with voriconazole 400 mg BID
Maltese: Efavirenz 300 mg QD, amministrazzjoni flimkien ma' voriconazole 400 mg BID
English: Blister foil for 200 mg film-coated tablets (all blister packs)
Maltese: Fojl tal-folji għal 200 mg pilloli miksijin b'rita (il-pakketti tal-folji kollha)
English: No subject experienced an interval exceeding the potentially clinically-relevant threshold of 500 msec.
Maltese: L-ebda suġġett ma esperjenza intervall li qabeż il-limitu potenzjalment klinikament rilevanti ta' 500 msec.
English: 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).
Maltese: 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).
English: 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).
Maltese: 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).
English: Each bag contains 50 ml of sodium chloride 0.9% in Water for Injections.
Maltese: Kull borża fiha 50 ml ta' sodium chloride 0.9% fl-Ilma tal-Injezzjonijiet.
English: VFEND 50 mg film-coated tablets White to off-white, round tablet, debossed “Pfizer” on one side and “VOR50”on the reverse.
Maltese: Pillola ta' kulur abjad għal offwajt, tonda, bi “Pfizer” imnaqqax fuq naħa u “VOR50” fuq in-naħa loħra.
English: 8 mg/kg dose (number of vials)
Maltese: doża ta' 8 mg/kg (numru ta' kunjetti)
English: 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
Maltese: 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
English: 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.
Maltese: 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.
English: Increased tacrolimus levels have been associated with nephrotoxicity.
Maltese: Livelli akbar ta' tacrolimus ġew assoċjati ma' nefrotossiċità.
English: Coadministration of voriconazole and sirolimus is contraindicated (see section
Maltese: Amministrazzjoni ta' voriconazole flimkien ma' sirolimus huwa kontraindikat (ara sezzjoni 4.3).
English: 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.
Maltese: 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.
English: 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.
Maltese: 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.
English: HDPE tablet containers containing 2, 30 or 100 film-coated tablets.
Maltese: Kontenituri tal-HDPE għall-pilloli li fihom 2, 30 jew 100 pillola miksija b'rita.
English: It is therefore recommended to use the oral suspension formulation in children aged 2 to <12.
Maltese: Għalhekk huwa rrakkomandat li tintuża l-formulazzjoni tas-suspensjoni orali fi tfal ta' 2 sa <12-il sena.
English: Increased ciclosporin levels have been associated with nephrotoxicity.
Maltese: Livelli akbar ta' ciclosporin ġew assoċjati ma' nefrotossiċità.
English: • Oxycodone and other long-acting opiates such as hydrocodone (used for moderate to severe pain)
Maltese: • Oxycodone u opiates oħra li jaħdmu fuq tul ta' żmien bħal hydrocodone (użati kontra l-uġigħ moderat u sever)
English: 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.
Maltese: 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.
English: • Not for administration as a bolus injection.
Maltese: • M'għandux jingħata bħala injezzjoni bolus.
English: Efavirenz (CYP450 inducer; CYP3A4 inhibitor and substrate) When voriconazole is coadministered with efavirenz the dose of voriconazole should be increased to 400 mg every 12 hours and the dose of efavirenz should be decreased to 300 mg every 24 hours (see sections 4.2, 4.3 and 4.5).
Maltese: Meta voriconazole jiġi amministrat ma' efavirenz, id-doża ta' voriconazole għandha tiżdied għal 400 mg kull 12-il siegħa u d-doża ta' efavirenz għandha tiġi mnaqqsa għal 300 mg kull 24 siegħa (ara sezzjonijiet 4.2, 4.3 u 4.5).
English: Following constitution, the volume of the suspension is 75 ml, providing a usable volume of 70 ml.
Maltese: Wara li tiġi kostitwita, il-volum tas-suspensjoni jkun 75 ml, li jipprovdi volum użabbli ta' 70 ml.
English: 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.
Maltese: 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.
English: IFI to day 100
Maltese: Suċċess f'jum 100
English: Other Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) (e.g., delavirdine, nevirapine) [CYP3A4 substrates, inhibitors or CYP450 inducers]
Maltese: Inibituri oħra tan-NonNucleoside Reverse Transcriptase Inhibitors (NNRTIs) (e.ż., delavirdine, nevirapine)
English: 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).
Maltese: 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).
English: 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.
Maltese: 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.
English: Blister foil for 50 mg film-coated tablets (all blister packs)
Maltese: Fojl tal-folji għal 50 mg pilloli miksijin b'rita (il-pakketti tal-folji kollha)
English: 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.
Maltese: 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.
English: VFEND 50 mg film-coated tablets VFEND 200 mg film-coated tablets Voriconazole
Maltese: VFEND 50 mg pilloli miksijin b'rita VFEND 200 mg pilloli miksijin b'rita Voriconazole
English: Pharmacokinetics in special patient groups
Maltese: Farmakokinetika fi gruppi ta' pazjenti speċjali
English: 8 mg/kg twice daily
Maltese: 8 mg/kg darbtejn kuljum
English: 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).
Maltese: 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).
English: • 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.
Maltese: • Checklist tal-Professjonist fil-Qasam Mediku (HCP) għal Fototossiċità, SCC u Tossiċità talFwied
English: Clinical studies examining QTc interval
Maltese: Studji kliniċi li eżaminaw l-intervall QTc
English: Duration of prophylaxis
Maltese: Tul ta' żmien tal-profilassi
English: VFEND must not be diluted with 4.2% Sodium Bicarbonate Infusion.
Maltese: VFEND m'għandux jiġi dilwit b'4.2% Infużjoni ta' Bikarbonat tas-Sodju.
English: 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.
Maltese: 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.
English: Vial contains 200 mg of voriconazole.
Maltese: Kunjett fih 200 mg ta' voriconazole.
English: 300 mg QD (coadministered with voriconazole 400 mg BID)
Maltese: 300 mg QD (amministrat flimkien ma' voriconazole 400 mg BID)
English: 4 mg/kg twice daily 200 mg twice daily 100 mg twice daily
Maltese: 4 mg/kg darbtejn kuljum200 mg darbtejn kuljum 100 mg darbtejn kuljum
English: 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.
Maltese: 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.
English: 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.
Maltese: 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.
English: 100 mg (2.5 ml) twice daily
Maltese: 100 mg (2.5 ml) darbtejn kuljum
English: 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.
Maltese: 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.
English: Coadministration with St. John's Wort (see section 4.5).
Maltese: John's Wort (fexfiex) (ara sezzjoni 4.5).
English: 400 mg (10 ml) every 12 200 mg (5 ml) every 12
Maltese: 400 mg (10 ml) kull 12il siegħa
English: 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).
Maltese: 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).
English: • you are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome'.
Maltese: • 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'.
English: Includes drug-induced liver injury, hepatitis toxic, hepatocellular injury and hepatotoxicity.
Maltese: Tinkludi korriment tal-fwied ikkaġunat mill-mediċina, epatite tossika, korriment epatoċellulari u tossiċità talfwied.
English: • Sinus bradycardia.
Maltese: Siringa waħda