FrancophonIA/ELRC3.0 huggingface dataset:
English: After IV voriconazole therapy, the median duration of oral voriconazole therapy was 76 days (range 2-232 days).
Maltese: Wara trattament b'voriconazole IV it-trattament b'voriconazole orali dam għal-medja ta' 76 jum (medda ta' 2-232 jum).
English: • Efavirenz (used for treating HIV) in doses of 400 mg and above once daily
Maltese: • Efavirenz (użat għall-kura tal-HIV) f'dożi ta' 400 mg u aktar darba kuljum
English: Co-administration with St John's Wort (see section 4.5).
Maltese: John's Wort (fexfiex) (ara sezzjoni 4.5).
English: When voriconazole is coadministered with efavirenz the dose of voriconazole should be increased to 400 mg every 12 hours and that of efavirenz should be decreased to 300 mg every 24 hours (see sections 4.2, 4.3 and
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: 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: Fuq bażi tal-analiżi farmakokinetika tal-popolazzjoni fi 112-il pazjent pedjatriku immunokompromess ta' bejn 2 u <12-il sena u 26 adolexxent immunokompromess ta' bejn 12 u <17-il sena.
English: In vitro activity against clinical isolates has been observed for Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp., Histoplasma capsulatum, with most strains being inhibited by concentrations of voriconazole in the range 0.05 to 2 μg/ml.
Maltese: Attività in vitro kontra iżolati kliniċi kienet osservata għal Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp.
English: Infusion-related reactions, predominantly flushing and nausea, have been observed during administration of the intravenous formulation of voriconazole.
Maltese: Reazzjonijiet relatati mal-infużjoni, predominantament fwawar u dardir, ġew osservati matul amministrazzjoni tal-formolazzjoni ġol-vini ta' voriconazole.
English: Voriconazole may be coadministered with efavirenz if the voriconazole maintenance dose is increased to 400 mg BID and the efavirenz dose is decreased to 300 mg QD.
Maltese: Voriconazole jista' jkun amministrat flimkien ma' efavirenz jekk id-doża ta' manteniment ta' voriconazole tiżdied għal 400 mg BID u d-doża ta' efavirenz titnaqqas għal 300 mg QD.
English: Teenagers aged 12 to 14 years weighing 50 kg or more; and all teenagers older than 14
Maltese: Teenagers ta' bejn 12 sa 14-il sena li jiżnu 50 kg jew aktar; u t-teenagers kllha akbar minn 14il sena
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 funġiċida in vitro kontra patoġeni fungali emerġenti, fosthom dawk bħal Scedosporium jew Fusarium li għandhom suxxettibilità limitata għal aġenti antifungali eżistenti.
English: Renal adverse reactions
Maltese: Reazzjonijiet avversi tal-vista
English: Psychiatric disorders depression, hallucination, anxiety, insomnia, agitation, confusional state
Maltese: Disturbi psikjatriċi depressjoni, alluċinazzjoni, ansjetà, nuqqas ta' rqad, aġitazzjoni, stat konfużjonali
English: Medicinal product [Mechanism of Interaction]
Maltese: Prodott mediċinali [Mekkaniżmu ta' interazzjoni]
English: The predicted total exposures in children following IV maintenance doses of 4 and 8 mg/kg twice daily were comparable to those in adults following 3 and 4 mg/kg IV twice daily, respectively.
Maltese: L-esponimenti totali mbassra fit -tfal wara dożi ta' manteniment fil-vina ta' 4 u 8 mg/kg darbtejn kuljum kienu kumparabbli ma' dawk tal-adulti wara dożi fil-vina ta' 3 u 4 mg/kg darbtejn kuljum, rispettivament.
English: Long -Acting Opiates [CYP3A4 substrates] Oxycodone (10 mg single dose)
Maltese: Opiates li jaħdmu fuq tul ta' żmien [sottostrati ta' CYP3A4] Oxycodone (doża waħda ta' 10 mg)
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: As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Maltese: Billi inti se tingħata din il-mediċina taħt sorveljanza medika mill-qrib, mhux probabbli li tfalli doża.
English: Sodium Chloride 9 mg/ml (0.9%) Solution for Injection Compound Sodium Lactate Intravenous Infusion 5% Glucose and Lactated Ringer's Intravenous Infusion
Maltese: 9 mg/ml (0.9%) Soluzzjoni għall-Injezzjoni ta' Sodium Chloride Infużjoni ta' Compound Sodium Lactate ġol-vini.
English: • Sirolimus (used in transplant patients)
Maltese: • Sirolimus (użat f'pazjenti tat-trapjanti)
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 taċ-ċitokromu fungali P450 milli għas-sistemi diversi taċ-ċitokromu fungali P450 tal-mammiferi.
English: Eye disorders visual impairment6
Maltese: Disturbi flgħajnejn indeboliment viżwali6
English: Depending on the severity of symptoms, consideration should be given to stopping treatment (see section 4.8).
Maltese: Jiddependi fuq is-severità tas-sintomi, għandha tingħata kunsiderazzjoni għat-twaqqif tat-trattament (ara sezzjoni 4.8).
English: Increased tacrolimus levels have been associated with nephrotoxicity.
Maltese: Livelli ogħla ta' tacrolimus ġew assoċjati b'nefrotossiċità.
English: : Successful response to voriconazole therapy was seen in 16 (6 complete, 10 partial responses) of 28 patients with S. apiospermum and in 2 (both partial responses) of 7 patients with S. prolificans infection.
Maltese: Rispons ta' suċċess għal terapija b'voriconazole kien muri f'16 (6 risponsi sħaħ, 10 parzjali) minn 28 pazjent b'infezzjoni ta' S. apiospermum u fi 2 (it-tnejn risponsi parzjali) minn 7 pazjenti b'infezzjoni ta' S. prolificans.
English: The overall incidence of transaminase increases >3 xULN (not necessarily comprising an adverse event) in the voriconazole clinical programme was 18.0% (319/1768) in adults and 25.8% (73/283) in paediatric subjects who received voriconazole for pooled therapeutic and prophylaxis use.
Maltese: L-inċidenza globali ta' zidiet fit -transaminase >3 x ULN (mhux bilfors jinkludu episodju avvers) fil-programm kliniku b'voriconazole kienet 18.0% (319/1,768) fl-adulti u 25.
English: When multiple doses of voriconazole are administered with high fat meals, Cmax and AUCτ are reduced by 34 % and 24 %, respectively.
Maltese: Meta dożi multipli ta' voriconazole jiġu mogħtija ma' ikliet b'kontenut għoli ta' xaħam, Cmax u AUCτ jitnaqqsu b'34% u 24%, rispettivament.
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported with the use of voriconazole.
Maltese: Reazzjonijiet avversi severi tal-ġilda (SCARs, severe cutaneous adverse reactions) li jinkludu sindrome ta' Stevens-Johnson (SJS, Steven-Johnson syndrome), nekroliżi epidermika tossika (TEN, toxic epidermal necrolysis), u reazzjoni għall-mediċina b'sintomi ta' esinofilja u sistemiċi (DRESS, drug reaction with eosinophilia and systemic symptoms) li jistgħu jkunu ta' periklu għall-ħajja jew fatali, ġew irrappurtati bl-użu ta' voriconazole.
English: A relationship between plasma concentrations and age was observed.
Maltese: Kienet osservata relazzjoni bejn il-konċentrazzjonijiet fil-plasma u l-età.
English: The terminal half-life of voriconazole depends on dose and is approximately 6 hours at 200 mg (orally).
Maltese: Il-half life terminali ta' voriconazole tiddependi fuq id-doża u hija madwar 6 sigħat b'doża ta' 200 mg (orali).
English: Voriconazole Hikma contains the active substance voriconazole.
Maltese: Voriconazole Hikma fih is-sustanza attiva voriconazole.
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: Other medicines and Voriconazole Hikma
Maltese: Mediċini oħra u Voriconazole Hikma
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: Voriconazole Hikma powder for solution for infusion needs to first be reconstituted with either 19 ml of water for injections or 19 ml of sodium chloride 9 mg/ml (0.9%) solution for injection to obtain an extractable volume of 20 ml of clear concentrate containing 10 mg/ml voriconazole.
Maltese: It-trab huwa rikostitwit bi 19 ml ta' 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: This metabolite has minimal antifungal activity and does not contribute to the overall efficacy of voriconazole.
Maltese: Dan il-metabolit għandu attività antifungali limitata u ma jikkontribwixxix għall-effikaċja globali ta' voriconazole.
English: Efavirenz 300 mg QD, coadministered with voriconazole 400 mg BID)*
Maltese: Efavirenz 300 mg QD, mogħti flimkien ma' voriconazole 400 mg BID)*
English: ≤S (Susceptible)
Maltese: ≤S
English: This enzyme exhibits genetic polymorphism.
Maltese: Dan l-enzim jippreżenta polimorfiżmu ġenetiku.
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 Cmax u AUCτ f'irġiel anzjani b'saħħithom (≥ 65 sena) kienu 61% u 86% ogħla, rispettivament, milli f'irġiel żgħażagħ b'saħħithom (18-45 sena).
English: • Anxiety, depression, confusion, agitation, inability to sleep, hallucinations
Maltese: • Ansjetà, depressjoni, konfużjoni, aġitazzjoni, ma tkunx tista' torqod, alluċinazzjonijiet
English: While being treated with Voriconazole Hikma:
Maltese: Jekk tieqaf tieħu Voriconazole Hikma:
English: An 8 mg/kg intravenous dose will provide voriconazole exposure approximately 2-fold higher than a 9 mg/kg oral dose.
Maltese: 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.
English: • Treatment of serious fungal infections caused by Scedosporium spp.
Maltese: • infezzjonijiet fungali serji kkawżati minn Scedosporium spp.
English: The direction of the arrow for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range.
Maltese: Id-direzzjoni tal-vleġġa għal kull parametru farmakokinetiku hija bbażata fuq livell ta' kunfidenza ta' 90% tal-medda ġeometrika medja fi ħdan (↔), taħt (↓) jew ‘il fuq (↑) mil-medda ta' 80-125%.
English: Prophylaxis should be as short as possible depending on the risk for developing invasive fungal infection (IFI) as defined by neutropenia or immunosuppression.
Maltese: Il-profilassi għandha tkun qasira kemm jista' jkun skont ir-riskju li titfaċċa infezzjoni fungali invażiva (invasive fungal infection, IFI), kif definit minn newtropenija jew immunosoppressjoni.
English: Unless otherwise specified, drug interaction studies have been performed in healthy adult male subjects using multiple dosing to steady state with oral voriconazole at 200 mg twice daily (BID).
Maltese: Sakemm mhux speċifikat mod ieħor, l-istudji dwar l-interazzjoni tal-mediċina saru fuq suġġetti adulti irġiel b'saħħithom billi ntuża dożaġġ multiplu għal stat stabbli b'voriconazole orali f'doża ta' 200 mg darbtejn kuljum (BID).
English: In addition VORICONAZOLE HIKMA has been associated with phototoxicity including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria.
Maltese: Barra minn hekk VORICONAZOLE HIKMA kien assoċjat ma' fototossiċità li tinkludi reazzjonijiet bħal nemex, lentigo, u keratożi aktinika u pseudoporphyria.
English: • Indinavir and other HIV protease inhibitors (used for treating HIV)
Maltese: • Indinavir u inibituri oħra tal-protease ta' l-HIV (użati għall-kura ta' l-HIV)
English: A satisfactory global response (complete or partial resolution of all attributable symptoms signs, radiographic/bronchoscopic abnormalities present at baseline) was seen in 53 % of voriconazole-treated patients compared to 31 % of patients treated with comparator.
Maltese: Intwera rispons globali sodisfaċenti (għajbien sħiħ jew parzjali tas-sinjali kollha tas-sintomi attribwibbli, anormalitajiet radjugrafiċi/bronkoskopiċi preżenti fil-linja bażi) fi 53% tal-pazjenti kkurati b'voriconazole meta mqabbel mal-31% tal-pazjenti kkurati bil-komparatur.
English: In clinical trials there were 3 cases of accidental overdose.
Maltese: F'testijiet kliniċi kien hemm 3 każijiet ta' doża eċċessiva aċċidentali.
English: • Loss of most fibers in the optic nerve clouding of the cornea, involuntary movement of the eye
Maltese: • Telf ta' ħafna mill-fibri fin-nerv tal-għajnejn, kornea mtappna, moviment involontarju talgħajn.
English: 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.
Maltese: 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.
English: 9 mg/kg every 12 hours
Maltese: 9 mg/kg darbtejn kuljum
English: In vitro studies show that the metabolism of voriconazole may be inhibited by NNRTIs and voriconazole may inhibit the metabolism of NNRTIs.
Maltese: Studji in vitro wrew li l-metaboliżmu ta' voriconazole jista' jiġi impedut b'NNRTIs u voriconazole jista' wkoll jimpedixxi l-metaboliżmu ta' NNRTIs.
English: Survived to day 180
Maltese: Baqgħu ħajjin sa jum 180
English: PHARMACEUTICAL PARTICULARS
Maltese: PROPREJETAJIET FARMAKOLOĠIĊI
English: Patients being treated with voriconazole are likely to be treated concomitantly with nephrotoxic medicinal products and have concurrent conditions that may result in decreased renal function (see section 4.8).
Maltese: Il-pazjenti li jkunu qed jiġu kkurati b'voriconazole huma probabbli li jiġu kkurati fl-istess waqt bi prodotti mediċinali nefrotossiċi u jkollhom kondizzjonijiet konkorrenti li jistgħu jwasslu għal funzjoni mnaqqsa tal-kliewi (ara sezzjoni 4.8).
English: Warfarin (30 mg single dose, coadministered with 300 mg BID voriconazole) [CYP2C9 substrate] Other oral coumarins (e.g., phenprocoumon, acenocoumarol) [CYP2C9 and CYP3A4 substrates]
Maltese: Warfarin (doża waħda ta' 30 mg amministrata flimkien ma' 300 mg BID voriconazole) [sottostrat ta' CYP2C9]
English: After dilution:
Maltese: Wara d-dilwazzjoni:
English: The oral maintenance dose of 200 mg (or 100 mg for patients less than 40 kg) achieves a voriconazole exposure similar to 3 mg/kg IV. A 300 mg (or 150 mg for patients less than 40 kg) oral maintenance dose achieves an exposure similar to 4 mg/kg IV.
Maltese: Id-doża orali ta' manteniment ta' 300 mg (jew 150 mg għal-pazjenti li l-piż tagħhom huwa anqas minn 40 kg) twassal għal espożizzjoni simili għal dik ta' 4 mg/kg IV.
English: All other adolescents (12 to 14 years and ≥50 kg; 15 to 17 years regardless of body weight) Voriconazole should be dosed as adults.
Maltese: Fl-adolexxenti l-oħra kollha (12 sa 14-il sena u ≥50 kg; 15 sa 17-il sena irrispettivament mill-piż tal-ġisem) id-doża ta' voriconazole għandha tkun bħal tal-adulti.
English: • Omeprazole (used for treating ulcers)
Maltese: • Omeprazole (użat għall-kura ta' l-ulċeri)
English: unspecified (including cysts and polyps) Blood and lymphatic system disorders agranulocytosis1, pancytopenia, thrombocytopenia2, leukopenia, anaemia bone marrow failure, lymphadenopathy, eosinophilia disseminated intravascular coagulation
Maltese: Disturbi taddemm u tassistema limfatika agranuloċitożi 1, panċitopenja, tromboċitopenja 2, lewkopenja, anemija insuffiċjenza talmudullun, limfadenopatija, esinofilja koagulazzjoni intravaskulari mifruxa
English: Co-administration of voriconazole and high doses of ritonavir (400 mg and above BID) is contraindicated (see section 4.3).
Maltese: Voriconazole flimkien ma' dożi għoljin ta' ritonavir (400 mg u ogħla BID) hu kontraindikat (ara sezzjoni 4.3).
English: • Fever
Maltese: • Pankrejatite
English: Ritonavir (potent CYP450 inducer; CYP3A4 inhibitor and substrate) Co-administration 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 4.5 and 4.3).
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: • Itchiness
Maltese: L-KITBA
English: Interaction Geometric mean changes (%)
Maltese: Bdil fil-medja ġeometrika talinterazzjoni (%)
English: A higher frequency of liver enzyme elevations was observed in the paediatric population (see section 4.8).
Maltese: Ġiet osservata frekwenza ogħla ta' żidiet ta' enzimi fil-fwied fil-popolazzjoni pedjatrika (ara sezzjoni 4.8).
English: Photosensitivity reactions, such as ephelides, lentigo and actinic keratosis, have been reported, especially during long-term therapy (see section 4.4).
Maltese: Kienu rrapportati reazzjonijiet ta' fotosensittività bħal nemex, lentigo u keratożi aktinika,, speċjalment waqt terapija fuq perjodu fit-tul (ara sezzjoni 4.4).
English: 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.
Maltese: Voriconazole ġie mqabbel ma' itraconazole bħala profilassi primarja fi studju bit-tikketta tingħaraf, komparattiv, multiċentriku, ta' riċevituri alloġeniċi adulti u adolexxenti ta' HSCT mingħajr IFIs li ġew ikkonfermati jew li setgħu seħħew fil-passat.
English: Voriconazole Hikma contains sodium
Maltese: Kif jidher Voriconazole Hikma u l-kontenut tal-pakkett
English: Chemical and physical stability of the of the diluted solutions for infusion has been demonstrated for 36 hours at 2°C to 8°C followed by 3 hours at room temperature.
Maltese: L-istabbiltà kimika u fiżika tas-soluzzjonijiet dilwiti għall-infużjoni ġew murija għal 36 siegħa f'temperatura ta' 2°C sa 8°C segwiti bi 3 sigħat f'temperatura ambjentali tal-kamra.
English: Infections and infestations sinusitis pseudomembranous colitis
Maltese: Infezzjonijiet u infestazzjoniji et sinusite kolite psewdomembranuż
English: Non-infectious periostitis with elevated fluoride and alkaline phosphatase levels has been reported in transplant patients.
Maltese: Kien hemm rapporti ta' perjostite (periostitis) mhux infettiva b'livelli ta' fluoride u alkaline phosphate għoljin f'pazjenti tat-trapjanti.
English: The clinical efficacy data were supported by limited susceptibility data.
Maltese: Id-dejta dwar leffikaċja klinika kienet sostnuta b'dejta limitata dwar is-suxxettibilità.
English: 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 bit-tikketta tingħaraf, mhux komparattiv, multiċentriku, ta' riċevituri adulti alloġeniċi ta' HSCT mingħajr IFIs li ġew ikkonfermati jew li setgħu seħħew fil-passat.
English: In an oral multiple dose study, Cmax and AUCτ for healthy young females were 83 % and 113 % higher, respectively, than in healthy young males (18-45 years).
Maltese: Fi studju ta' doża multipla orali, Cmax u AUC għal nisa żgħażagħ b'saħħithom kienu 83% u 113% ogħla, rispettivament, milli f'irġiel żgħażagħ b'saħħithom (18-45 sena).
English: Musculoskelet al and connective tissue disorders back pain arthritis periostitis*
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi uġigħ tad-dahar artrite perjostite*
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: Proven or probable IFIs developed in 7.5% (3/40) of patients during the first year after HSCT, including one candidemia, one scedosporiosis (both relapses of prior IFI), and one zygomycosis.
Maltese: IFIs li ġew ikkonfermati jew li setgħu seħħew żviluppaw f'7.5% (3/40) tal-pazjenti matul l-ewwel sena wara HSCT, inklużi kandidemija waħda, xedosporjożi waħda (it-tnejn kienu rkadew minn IFIs qabel), u żigomikożi waħda.
English: See section 4.4.
Maltese: ewwel 24 siegħa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1004/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1004/001
English: Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:
Maltese: Voriconazole huwa aġent antifungali triazole bi spettru wiesa' li huwa indikat fl-adulti u fit-tfal ta'
English: *Oral dosage forms of voriconazole are available from other manufacturers Note: Based on a population pharmacokinetic analysis in 112 immunocompromised paediatric patients aged 2 to <12 years and 26 immunocompromised adolescents aged 12 to <17 years.
Maltese: Id-dożi rrakkomandati fil-pazjenti tfal u adolexxenti 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 adolexxenti immunokompromessi fl-etajiet ta' 12 sa <17-il sena.
English: Nine subjects in the voriconazole group and five in the amphotericin B followed by fluconazole group also had mycologically proven infection in deep tissue.
Maltese: Disa' suġġetti fil-grupp ta' voriconazole u 5 fil-grupp ta' amphotericin B segwit bi fluconazole wkoll kellhom infezzjoni ppruvata b'mod mikoloġiku fit-tessut fond.
English: Renal and urinary disorders renal failure acute, haematuria renal tubular necrosis, proteinuria, nephritis
Maltese: Disturbi filkliewi u fissistema urinarja insuffiċjenza talkliewi akuta, ematurja nekrosi tubulari talkliewi, proteinurja, nefrite
English: 100 mg twice daily
Maltese: 400 mg kull 12-il