FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Maltese: 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'individwi b'saħħithom.
English: • Ciclosporin (used in transplant patients)
Maltese: • Ciclosporin (użat f'pazjenti tat-trapjanti)
English: No pharmacokinetic data are available for patients with severe hepatic cirrhosis (Child-Pugh C) (see sections 4.2 and 4.4).
Maltese: Mhux disponibbli tagħrif farmakokinetiku għal pazjenti b'ċirrożi tal-fwied severa (Child-Pugh C) (ara sezzjonijiet 4.2 u 4.4).
English: Excipient with known effect: Each vial contains 217.6 mg sodium For the full list of excipients, see section 6.1.
Maltese: Eċċipjent b'effett magħruf: kull kunjett fih 217.6 mg sodju Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: The safety of voriconazole was also investigated in 158 additional paediatric patients aged 2 to <12 years in compassionate use programs.
Maltese: Is-sigurtà ta' voriconazole ġiet investigata wkoll f'158 pazjent pedjatriku addizzjonali fletajiet ta' 2 sa <12-il sena fi programmi ta' użu ta' kompassjoni.
English: 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.
Maltese: 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).
English: 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.
Maltese: Fi studju bit-tikketta tingħaraf, 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, it-twaqqif permanenti ta' voriconazole minħabba reazzjonijiet avversi ġie rapportat f'39.3% tal-individwi kontra 39.6% tal-individwi trattati b'itraconazole.
English: Ciclosporin (in stable renal transplant recipients receiving chronic ciclosporin therapy)
Maltese: Ciclosporin (f'riċevituri stabbli ta' trapjant tal-kliewi li qed jirċievu terapija kronika b'ciklosporin)
English: Intravenous
Maltese: Interazzjoni
English: 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
Maltese: 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
English: Co-administration 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).
Maltese: L-amministrazzjoni flimkien mas-sottostratti 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).
English: The MITT group included 40 patients with prior IFI, including 31 with aspergillosis, 5 with candidiasis, and 4 with other IFI.
Maltese: Il-grupp MITT kien jinkludi 40 pazjent b'IFIs fil-passat, inkluż 31 b'asperġillosi, 5 b'kandidjasi, u 4 b'IFIs oħrajn.
English: The major metabolite of voriconazole is the N-oxide, which accounts for 72 % of the circulating radiolabelled metabolites in plasma.
Maltese: Il-metabolit prinċipali ta' voriconazole huwa l-ossidu N, li jammonta għal 72 % tal-metaboliti radjutikkettati li jiċċirkolaw fil-plasma.
English: Voriconazole (N=125)
Maltese: Aħħarin tal-Istudju Voriconazole (N=125)
English: • Tacrolimus (used in transplant patients)
Maltese: • Tacrolimus (użat f'pazjenti tat-trapjanti)
English: Phenytoin may be co-administered 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 IV BID jew minn 200 mg sa 400 mg BID orali, (100 mg sa 200 mg BID orali f'pazjenti li jiżnu inqas minn 40 kg) (ara sezzjoni 4.2).
English: Sodium Chloride 9 mg/ml (0.9%) Solution for Injection Compound Sodium Lactate Intravenous Infusion 5% Glucose and Lactated Ringer's Intravenous Infusion 5% Glucose and 0.45% Sodium Chloride Intravenous Infusion 5% Glucose Intravenous Infusion 5% Glucose in 20 mEq Potassium Chloride Intravenous Infusion 0.45% Sodium Chloride Intravenous Infusion 5% Glucose and 0.9% Sodium Chloride Intravenous Infusion
Maltese: Sodium Chloride 9 mg/ml (0.9%) Soluzzjoni għal Injezzjoni Kompożizzjoni ta' Infuzjoni ta' Sodium Lactate għal-gol-vina 5% Glucose u Lactated Ringer's Infużjoni ġol-Vina 5% Glucose u 0.45% Sodium Chloride 5% Infużjoni ġol-Vina 5% Glucose Infużjoni ġol-Vina
English: 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.
Maltese: Fi studju ta' doża multipla orali, AUC kien simili f'suġġetti b'ċirrożi tal-fwied moderata (ChildPugh B) mogħtija doża ta' manteniment ta' 100 mg darbtejn kuljum u suġġetti b'funzjoni normali tal-fwied mogħtija 200 mg darbtejn kuljum.
English: S-Ibuprofen Cmax ↑ 20% S-Ibuprofen AUC0-∞ ↑ 100%
Maltese: S-Ibuprofen Cmax ↑ 20% S-Ibuprofen AUC0-∞ ↑ 100% Diclofenac Cmax ↑ 114% Diclofenac AUC0-∞ ↑ 78%
English: Diclofenac (50 mg single dose)
Maltese: Diclofenac (doża waħda ta' 50 mg)
English: 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).
Maltese: 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).
English: On the basis of the high oral bioavailability (96 %; see section 5.2), switching between intravenous and oral administration is appropriate when clinically indicated.
Maltese: Fuq ilbażi tal-bijodisponibilità orali għolja (96%; ara sezzjoni 5.2), il-qalba bejn amministrazzjoni fil-vini u orali hija f'waqtha meta klinikament indikata.
English: Use of standard doses of voriconazole with efavirenz doses of 400 mg QD or higher is contraindicated (see section 4.3).
Maltese: Użu ta' dożi standard ta' voriconazole ma' dożi ta' efavirenz 400 mg QD jew ogħla hu kontraindikat (ara sezzjoni 4.3).
English: • Sinus bradycardia
Maltese: • Kanċer tal-ġilda
English: The second study enrolled 22 patients with invasive candidiasis including candidaemia (ICC), and esophageal candidiasis (EC) requiring either primary or salvage therapy, of whom 17 were included in the MITT efficacy analyses.
Maltese: It-tieni studju kellu rreġistrati fi ħdanu 22 pazjent b'kandidijażi invażiva inkluż kandidemija (ICC- invasive candidiasis including candidaemia), u kandidijażi esofageali (EC - esophageal candidiasis) li kellhom bżonn ta' terapija primarja jew ta' salvataġġ, li minnhom, 17 ġew inklużi fl-analiżi tal-effikaċja tal-MITT.
English: There have been post-marketing reports of prolonged visual adverse events (see section 4.4).
Maltese: Kien hemm rapporti ta' wara t-tqegħid fis-suq ta' avvenimenti avversi viżwali fit-tul (ara Sezzjoni 4.4).
English: >R (Resistant)
Maltese: >R
English: Ritonavir (protease inhibitor) [potent CYP450 inducer; CYP3A4 inhibitor and substrate] High dose (400 mg BID)
Maltese: Ritonavir (inibitur ta' protease) [induttur qawwi ta' CYP450; inibitur u sottostrat ta' CYP3A4] Doża għolja (400 mg BID)
English: Scedosporium and Fusarium infections Voriconazole was shown to be effective against the following rare fungal pathogens:
Maltese: Infezzjonijiet bi Scedosporium u Fusarium Voriconazole ntwera li kien effettiv kontra l-patoġeni fungali rari li ġejjin:
English: Monitoring for voriconazole associated 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: Pharmacokinetic-Pharmacodynamic analyses of clinical trial data identified positive associations between plasma voriconazole concentrations and both liver function test abnormalities and visual disturbances.
Maltese: 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.
English: IFI to day 180
Maltese: Punt ta' Sfondament ta' IFIJum 180
English: Voriconazole Hikma 200 mg powder for solution for infusion Voriconazole
Maltese: Voriconazole Hikma 200 mg trab għal soluzzjoni għall-infużjoni Voriconazole
English: Co-administration with rifampicin, carbamazepine and phenobarbital since these medicinal products are likely to decrease plasma voriconazole concentrations significantly (see section 4.5).
Maltese: 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).
English: • Nausea, vomiting, diarrhoea
Maltese: • Dardir, rimettar, dijarea
English: In the table below, since the majority of the studies were of an open nature all causality adverse reactions, and their frequency categories in 1,873 adults from pooled therapeutic (1,603) and prophylaxis (270) studies, by system organ classare listed.
Maltese: Fit-tabella ta' hawn isfel, billi l-maġġoranza ta' l-istudji kienu ta' natura miftuħa, r-reazzjonijiet avversi kollha ta' kawżalità, u l-kategoriji ta' frekwenza tagħhom f'1,873 adult minn studji terapewtiċi (1,603) u ta' profilassi (270) miġburin skont is-sistema tal-klassifika tal-organi, huma elenkati.
English: The ERG measures electrical currents in the retina.
Maltese: L-ERG ikejjel il-kurrenti elettriċi fir-retina.
English: EOT
Maltese: Lott
English: However, as there were only 9 cases available for EUCAST analysis, there is currently insufficient evidence to set clinical breakpoints for C. krusei.
Maltese: 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.
English: The median duration of study drug prophylaxis was 96 days for voriconazole and 68 days for itraconazole in the MITT group.
Maltese: Il-medjan tat-tul ta' żmien tal-profilassi bil-mediċina tal-istudju kien ta' 96 jum għal voriconazole u 68 jum għal itraconazole fil-grupp MITT.
English: 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).
Maltese: 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).
English: Voriconazole is haemodialysed with a clearance of 121 ml/min.
Maltese: Voriconazole jiġi ħemodijalizzat bi tneħħija ta' 121 ml/min.
English: Amphotericin B → fluconazole (N=122)
Maltese: fluconazole (N=122)
English: Metabolism and nutrition disorders oedema peripheral hypoglycaemia, hypokalaemia, hyponatraemia
Maltese: Disturbi filmetaboliżmu u n-nutrizzjoni edema periferali ipogliċemija, ipokalimja, iponatremija
English: No significant differences in Cmax and AUCτ were observed between healthy elderly females (≥ 65 years) and healthy young females (18-45 years).
Maltese: Ma kinux osservati differenzi sinifikanti f'Cmax u AUCτ bejn nisa anzjani b'saħħithom (65 sena) u nisa żgħażagħ b'saħħithom (18-45 sena).
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: After reconstitution each ml contains 10 mg of voriconazole.
Maltese: Wara r-rikostituzzjoni kull ml fih 10 mg ta' voriconazole.
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: 8 mg/kg twice daily
Maltese: 6 mg/kg kull 12-il
English: • Everolimus (used for treating advanced kidney cancer and in transplant patients)
Maltese: • Everolimus (użat għal trattament ta' kanċer avanzat fil-kliewi u f'pazjenti bi trapjanti).
English: Voriconazole is metabolised by, and inhibits the activity of, cytochrome P450 isoenzymes, CYP2C19, CYP2C9, and CYP3A4.
Maltese: Voriconazole huwa mmetabolizzat minn, u jinibixxi l-attività ta' l-isoenzimi taċ-ċitokromi P450, CYP2C19, CYP2C9, u CYP3A4.
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 għal 350 mg b'mod orali BID (100 mg sa 200 mg b'mod orali BID f'pazjenti li jiżnu inqas minn 40 kg) (ara sezzjoni 4.2).
English: Nervous system disorders headache convulsion, syncope, tremor, hypertonia3, paraesthesia, somnolence, dizziness brain oedema, encephalopathy4, extrapyramidal disorder5, neuropathy peripheral, ataxia, hypoaesthesia, dysgeusia hepatic encephalopathy, Guillain-Barre syndrome, nystagmus
Maltese: Disturbi fissistema nervuża uġigħ ta' ras konvulżjoni, sinkope, rogħda, ipertonja3, parasteżija, ngħas, sturdament edima fil-moħħ, enċefalopatija 4, disturb ekstrapiramidali 5, newropatija periferali, atassja, ipoestesija, tibdil fis-sens tat-togħma enċefalopatija epatika, sindromu ta' Guillain-Barre, nistagmu
English: • serious invasive Candida sp. infections when the fungus is resistant to fluconazole (another antifungal medicine),
Maltese: • infezzjonijiet invażivi serji ta' Candida sp. fejn il-moffa hija reżistenti għal fluconazole (mediċina antifungali oħra),
English: 300 mg QD (co-administered with voriconazole 350 mg BID)*
Maltese: 300 mg QD (amministrat flimkien ma' voriconazole 350 mg BID)*
English: Stevens-Johnson syndrome, phototoxicity, purpura, urticaria, dermatitis allergic, rash papular, rash macular, eczema toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), angioedema, Actinic keratosis*, pseudoporphyria erythema multiforme, psoriasis, drug eruption cutaneous lupus erythemato sus* ephelides*, lentigo*
Maltese: Disturbi filġilda u fittessuti ta' taħt il-ġilda raxx dermatite sfoljattiva, raxx makulari bl-infafet, ħakk, alopeċja, eritema sindromu ta' Stevens-Johnson, fototossiċità, purpura, urtikarja, dermatite allerġika, raxx papulari, raxx makulari, ekżema nekroliżi epidermika tossika, reazzjoni għallmediċina b'sintomi ta' esinofilja u sistemiċi (DRESS), anġjoedima, keratożi aktinika*, pseudoporphyria , eritema multiformi, psorjażi, eruzzjoni filġilda kull darba li tingħata doża lupus eritematożu s tal-ġilda *, nemex* u lentigo*
English: Ranitidine (150 mg BID) [increases gastric pH]
Maltese: Ranitidine (150 mg BID) [jgħolli l-pH fl-istonku]
English: Clinical studies examining QTc interval
Maltese: Studji kliniċi li eżaminaw l-Intervall QTc
English: Voriconazole Hikma must not be diluted with 4.2% Sodium Bicarbonate Infusion.
Maltese: Voriconazole Hikma m'għandux jiġi dilwit b'soluzzjoni tal-infużjoni ta' 4.2% sodium bicardonate.
English: Success at day 180*
Maltese: Suċċess f'Jum 180*
English: Short -acting Opiates [CYP3A4 substrates] Alfentanil (20 μg/kg single dose, with concomitant naloxone)
Maltese: Opiates li jaġixxu għal ħin qasir [sottostrati ta' CYP3A4] Alfentanil (doża waħda ta' 20 μg/kg, flimkien ma' naloxone)
English: 2 In clinical studies, response to voriconazole in patients with C glabrata infections was 21% lower compared to C. albicans, C. parapsilosis and C. tropicalis.
Maltese: 2 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.
English: Immune system disorders hypersensitivity anaphylactoid reaction
Maltese: Disturbi fissistema immuni sensittività eċċessiva reazzjoni anafilaktojdi
English: 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).
Maltese: 7% (6/7) u għal pazjenti b'EC, ir-rata ta' rispons globali f'EOT kienet 70% (7/10).
English: • Depressed function of the adrenal gland, underactive thyroid gland
Maltese: • Funzjoni depressa tal-glandola adrenali, glandola tat-tirojde mhux attiva biżżejjed
English: Each vial of Voriconazole Hikma contains 217.6 mg of sodium per vial.
Maltese: Kull kunjett ta' Voriconazole Hikma fih 217.6 mg ta' sodju.
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 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 fillista 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: The primary mode of action of voriconazole is the inhibition of fungal cytochrome P-450-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: 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: • Quinidine (used for irregular heart beat)
Maltese: • Quinidine (użat għal taħbit tal-qalb irregolari)
English: Gastrointestin al disorders diarrhoea, vomiting, abdominal pain, nausea cheilitis, dyspepsia, constipation, gingivitis peritonitis, pancreatitis, swollen tongue, duodenitis, gastroenteritis, glossitis
Maltese: Disturbi gastrointestinali dijarea, rimettar, uġigħ ta' żaqq, dardir kelite, dispepsja, kostipazzjoni, ġinġivite peritonite, pankreatite, ilsien minfuħ, duwodenite, gastroenterite, glossite
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: Children aged 2 to less than 12 years and teenagers aged 12 to 14 years weighing less than 50 kg
Maltese: Tfal minn 2 sa anqas minn 12-il sena u teenagers ta' bejn 12 u 14-il sena li ji#nu inqas minn 50 kg
English: Voriconazole (N=98)
Maltese: Aħħarin tal-Istudju Voriconazole (N=98)
English: 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.
Maltese: 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.
English: • Carbamazepine (used to treat seizures)
Maltese: • Carbamazepine (użat għall-kura ta' attakki ta' puplesija )
English: 3 Includes nuchal rigidity and tetany.
Maltese: 3 Tinkludi riġidità nuċali u tetanija.
English: - The other ingredient is sulfobutylether beta cyclodextrin sodium.
Maltese: TA' EĊĊIPJENTI Eċċipjent: Sulphobutylether beta cyclodextrin sodium.
English: The absolute bioavailability of voriconazole after oral administration is estimated to be 96 %.
Maltese: Ilbijodisponibilità assoluta ta' voriconazole wara amministrazzjoni orali hija stmata għal 96%.
English: 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 minimum inhibitory concentration (MICs) of less than 1 mg/L for voriconazole.
Maltese: 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.
English: Cimetidine (400 mg BID) [non-specific CYP450 inhibitor and increases gastric pH]
Maltese: Cimetidine (400 mg BID) [inibitur mhux speċifiku ta' CYP450 u jgħolli l-pH fl-istonku]
English: Voriconazole also significantly increases efavirenz plasma concentrations (see section 4.5, for lower doses see section 4.4).
Maltese: Voriconazole ukoll jżid b'mod sinifikanti il-konċentrazzjonijiet ta' efavirenz fil-plasma (ara sezzjoni 4.5, għal dożi aktar baxxi ara sezzjoni 4.4).
English: 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.
Maltese: Tnaqqis fid-doża ta' alfentanil, fentanyl u opiates oħra li jaġixxu għal żmien qasir bi struttura simili għal alfentanil u metabolizzanti minn CYP3A4 (eż. sufentanil) għandhom ikunu kkunsidrati.
English: Methadone (32-100 mg QD) [CYP3A4 substrate]
Maltese: Methadone (32-100 mg QD)