natgillin/translations-raw huggingface dataset:
1 sterile, single use syringe.
1 siringa sterili, li tintuża darba biss.
3 years
3 snin
For patients with ICC the global response rate at EOT was 85.7% (6/7) and for patients with EC the global response rate at EOT was 70% (7/10).
Għal pazjenti b'ICC ir-rata ta' rispons globali f'EOT kienet 85.7% (6/7) u għal pazjenti b'EC, ir-rata ta' rispons globali f'EOT kienet 70% (7/10).
Voriconazole has not been studied in patients with severe chronic hepatic cirrhosis (Child-Pugh C).
Voriconazole ma ġiex studjat f'pazjenti b'ċirrożi tal-fwied kronika severa (Child-Pugh C).
(See section 3 ‘How to take VFEND').
(Ara sezzjoni 3 ‘Kif għandek tieħu VFEND').
For the full list of excipients, see section 6.1.
Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
Voriconazole (N=248)
Punt taż-żmien Voriconazole (N=248)
Ritonavir Cmax and AUC ↔ Voriconazole Cmax  66% Voriconazole AUC  82%
Ritonavir Cmax u AUC ↔ Voriconazole Cmax  66% Voriconazole AUC  82%
6.5 Nature and contents of container
6.5 In-natura tal-kontenitur u x'hemm fih
In vitro activity against clinical isolates has been observed for Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp., and Histoplasma capsulatum, with most strains being inhibited by concentrations of voriconazole in the range 0.05 to 2 µg/ml.
Attività in vitro kontra iżolati kliniċi kienet osservata għal Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp., u Histoplasma capsulatum, bil-maġġoranza tal-forom jiġu mwaqqfa b'konċentrazzjonijiet ta' voriconazole fil-medda ta' 0.05 sa 2 g/ml.
Ibuprofen (400 mg single dose)
Ibuprofen (doża waħda ta' 400 mg)
VFEND contains sucrose
VFEND fih is-sucrose
Excipient: sulfobutylether beta cyclodextrin sodium.
Eċċipjent: sulfobutylether beta cyclodextrin sodium.
• Vinca alkaloids (e.g., vincristine and vinblastine) (used in treating cancer)
• Alkalojdi vinka (e.ż., vincristine u vinblastine) (użati fil-kura tal-kanċer)
Monitoring of pancreatic function
Monitoraġġ tal-funzjoni pankreas
Endocrine disorders adrenal insufficiency, hypothyroidism hyperthyroidism
Disturbi fissistema endokrinarja insuffiċjenza adrenali, ipotirojdiżmu ipertirojdiżmu
Prophylaxis with study drug was started immediately after HSCT: 224 received voriconazole and 241 received itraconazole.
Profilassi bil-mediċina tal-istudju nbdiet immedjatament wara HSCT: 224 irċivew voriconazole u 241 irċivew itraconazole.
Not for bolus injection.
Mhux għal injezzjoni bolus.
Warfarin (30 mg single dose, co- administered with 300 mg BID voriconazole) [CYP2C9 substrate]
Warfarin (doża waħda ta' 30 mg, amministrata flimkien ma' voriconazole 300 mg BID) [sustratt ta' CYP2C9]
In the 22 patients less than 2 years old who received voriconazole in a compassionate use programme, the following adverse reactions (for which a relationship to voriconazole could not be excluded) were reported: photosensitivity reaction (1), arrhythmia (1), pancreatitis (1), blood bilirubin increased (1), hepatic enzymes increased (1), rash (1) and papilloedema (1).
Fit-22 pazjent ta' anqas minn sentejn li rċevew voriconazole fi programm ta' użu ħanin, kienu rrapportati r-reazzjonijiet avversi li ġejjin (li għalihom ma setgħetx tiġi eskluża relazzjoni ma' voriconazole): reazzjoni ta' fotosensittività (1), arritmija (1), pankreatite (1), bilirubin fid-demm aktar (1), enzimi epatiċi aktar (1), raxx (1) u papilloedima (1).
9 mg/kg twice daily (a maximum dose of 350 mg twice daily)
9 mg/kg darbtejn kuljum (doża massima ta' 350 mg darbtejn kuljum)
VFEND 40 mg/ml powder for oral suspension
VFEND 40 mg/ml trab għal suspensjoni orali
VFEND 50 mg film-coated tablets EU/1/02/212/001-012
VFEND 50 mg pilloli miksijin b'rita EU/1/02/212/001-012
Tablets Patients 40 kg and above Patients less than 40 kg
Pilloli Pazjenti li jiżnu 40 kg u aktar
In vivo studies indicated that CYP2C19 is significantly involved in the metabolism of voriconazole.
Studji in vivo indikaw li CYP2C19 huwa involut b'mod sinifikanti fil-metaboliżmu ta' voriconazole.
• Phenytoin (used to treat epilepsy).
• Phenytoin (użat għall-kura ta' l-epilessija).
Step 6
Punt 6
Coadministration with CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine since increased plasma concentrations of these medicinal products can lead to QTc prolongation and rare occurrences of torsades de pointes (see section 4.5).
L-amministrazzjoni flimkien mas-sustratti ta' CYP3A4, terfenadine, astemizole, cisapride, pimozide jew quinidine billi konċentrazzjonijiet akbar ta' dawn il-prodotti mediċinali fil-plasma jistgħu jwasslu għal titwil tal-QTc u okkorrenzi rari ta' torsades de pointes (ara sezzjoni 4.5).
Dermatological reactions
Reazzjonijiet dermatoloġiċi
In vitro, voriconazole displays broad-spectrum antifungal activity with antifungal potency against Candida species (including fluconazole-resistant C. krusei and resistant strains of C. glabrata and C. albicans) and fungicidal activity against all Aspergillus species tested.
In vitro, voriconazole juri attività antifungali ta' spettru wiesgħa b'qawwa antifungali kontra speċi Candida (fosthom C. krusei reżistenti għal fluconazole u forom reżistenti ta' C. glabrata u C. albicans) u attività funġiċida kontra l-ispeċi Aspergillus kollha ttestjati.
In fluconazole-resistant non-albicans species, a successful outcome was seen in 3/3 C. krusei (complete responses) and 6/8 C. glabrata (5 complete, 1 partial response) infections.
Fi speċi mhux albicans reżistenti għal fluconazole, eżitu ta' suċċess kien muri fi 3/3 infezzjonijiet bil- C. krusei (risponsi sħaħ) u 6/8 infezzjonijiet bil- C. glabrata (5 risponsi sħaħ, rispons 1 parzjali).
Everolimus (CYP3A4 substrate, P-gp substrate)
Everolimus (sustratt CYP3A4, sustratt P-gp)
Everolimus [CYP3A4 substrate, P-gp substrate]
Everolimus [sustratt ta' CYP3A4, sustratt ta' P-gp]
ANNEX III
ANNESS III
• Rifampicin (used for treating tuberculosis)
• Rifampicin (użat għall-kura tat-tuberkulosi)
Includes immune thrombocytopenic purpura.
Tinkludi purpura tromboċitopenika immuni.
In an open-label, comparative, multicenter study comparing voriconazole and itraconazole as primary prophylaxis in adult and adolescent allogeneic HSCT recipients without prior proven or probable IFI, permanent discontinuation of voriconazole due to AEs was reported in 39.3% of subjects versus 39.6% of subjects in the itraconazole arm. Treatment-emergent hepatic AEs resulted in permanent discontinuation of study medication for 50 subjects (21.4%) treated with voriconazole and for 18 subjects (7.1%) treated with itraconazole.
Fi studju open-label, komparattiv, multiċentriku li qabbel voriconazole u itraconazole bħala profilassi primarja f'riċevituri adulti u adolexxenti alloġeniċi ta' HSCT mingħajr IFIs li ġew ikkonfermati jew li setgħu seħħew fil-passat, t-twaqqif permanenti ta' voriconazole minħabba AEs ġie rrappurtat f'39.3% tal-individwi kontra 39.6% tal-individwi trattati b'itraconazole.
There was evidence of attenuation with repeated doses of voriconazole.
Kien hemm evidenza ta' attenwazzjoni b'dożi ripetuti ta' voriconazole.
• Serious dermatological adverse reactions (including SCC) The frequency of phototoxicity reactions is higher in the paediatric population.
• Reazzjonijiet avversi dermatoloġiċi serji (inkluż SCC) Il-frekwenza ta' reazzjonijiet ta' fototossiċità hi ogħla fil-popolazzjoni fit-tfal.
• Ciclosporin (used in transplant patients)
• Ciclosporin (użat f'pazjenti tat-trapjanti)
No subject experienced an interval exceeding the potentially clinically-relevant threshold of 500 msec (see section 5.1).
Ebda suġġett ma esperjenza intervall li jaqbeż il-limitu kliniku potenzjalment rilevanti ta' 500 msec (ara sezzjoni 5.1).
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).
Efavirenz (induttur ta' CYP450; inibitur u sustratt ta' CYP3A4) 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).
Fluconazole (200 mg QD) [CYP2C9, CYP2C19 and CYP3A4 inhibitor]
Fluconazole (200 mg QD) [inibitur ta' CYP2C9, CYP2C19 u CYP3A4]
The absolute bioavailability of voriconazole after oral administration is estimated to be 96%.
Ilbijodisponibilità assoluta ta' voriconazole wara amministrazzjoni orali hija stmata għal 96%.
The plasma protein binding of voriconazole was similar in subjects with different degrees of renal impairment (see sections 4.2 and 4.4).
It-tqabbid ta' voriconazole mal-proteini tal-plasma kien simili f'suġġetti bi gradi differenti ta' indeboliment tal-kliewi (ara sezzjonijiet 4.2 u 4.4).
Diclofenac (50 mg single dose)
Diclofenac (doża waħda ta' 50 mg)
When multiple doses of voriconazole oral suspension are administered with high fat meals, Cmax and AUCτ are reduced by 58% and 37% respectively.
Meta dożi multipli tas-suspensjoni orali ta' voriconazole jingħataw ma' ikliet b'kontenut għoli ta' xaħam, Cmax u AUC jitnaqqsu bi 58 % u 37% rispettivament.
No pharmacokinetic data are available for patients with severe hepatic cirrhosis (Child-Pugh C) (see sections 4.2 and 4.4).
Mhux disponibbli tagħrif farmakokinetiku għal pazjenti b'ċirrożi tal-fwied severa (Child-Pugh C) (ara sezzjonijiet 4.2 u 4.4).
Timepoint
TIKKETTAR
Indinavir (800 mg TID) [CYP3A4 inhibitor and substrate]
Indinavir (800 mg TID) [inibitur u sustratt ta' CYP3A4]
Other treated fungal infections (often with either partial or complete response) included isolated cases of Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp.
Infezzjonijiet fungali oħra kkurati (ħafna drabi jew b'rispons parzjali jew sħiħ) kienu jinkludu każi iżolati ta' Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp. fosthom P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis u Trichosporon spp. fosthom infezzjonijiet T. beigelii.
Required Volumes of 10 mg/ml VFEND Concentrate
Volumi Meħtieġa ta' 10 mg/ml ta' Konċentrat VFEND
VFEND contains lactose
Borża tal-infużjoni
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).