FrancophonIA/ELRC3.0 huggingface dataset:
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 open-label, mhux komparattiv, multiċentriku, ta' riċevituri adulti alloġeniċi ta' HSCT mingħajr IFIs li ġew ikkonfermati jew li setgħu seħħew fil-passat.
English: Compared to efavirenz 600 mg QD, Efavirenz Cmax ↔ Efavirenz AUCτ  17%
Maltese: Efavirenz Cmax ↔ Efavirenz AUCτ 17%
English: Metabolism and nutrition disorders oedema peripheral hypoglycaemia, hypokalaemia, hyponatraemia
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni edema periferali ipogliċemija, ipokalimja, iponatremja
English: Prednisolone (60 mg single dose)
Maltese: Prednisolone (doża waħda ta' 60 mg)
English: Infections and infestations sinusitis pseudomembranou s colitis
Maltese: Infezzjonijiet u infestazzjoniji et sinusite kolite psewdomembranik a
English: Frequent monitoring for adverse reactions and toxicity related to NSAIDs is recommended.
Maltese: Huwa rrakkomandat monitoraġġ frekwenti għal episodji avversi u tossiċità relatati ma' NSAIDs.
English: Itraconazo le
Maltese: TA' EĊĊIPJENTI
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 rreġistraw għalih 22 pazjent b'kandidjażi invażiva li tinkludi kandidemija (ICC), u kandidjażi esofaġeali (EC) li kienu jeħtieġu terapija primarja jew ta' salvataġġ, li 17 minnhom kienu inklużi flanaliżijiet tal-effikaċja MITT.
English: Voriconazole Cmax  93% Voriconazole AUCτ  96%
Maltese: Voriconazole Cmax 93% Voriconazole AUC 96%
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: 2 film-coated tablets 10 film-coated tablets 14 film-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 10x1 film-coated tablets 14x1 film-coated tablets 28x1 film-coated tablets 30x1 film-coated tablets 56x1 film-coated tablets 100x1 film-coated tablets
Maltese: 2 pilloli miksijin b'rita 10 pilloli miksijin b'rita 14-il pillola miksijin b'rita 20 pillola miksijin b'rita 28 pillola miksijin b'rita 30 pillola miksijin b'rita 50 pillola miksijin b'rita 56 pillola miksija b'rita 100 pillola miksijin b'rita 10x1 pillola miksija b'rita 14x1 pillola miksija b'rita 28x1 pillola miksija b'rita 30x1 pillola miksija b'rita 56x1 pillola miksija b'rita 100x1 pillola miksija b'rita
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 nonlinear pharmacokinetics were in agreement with those observed in healthy subjects.
Maltese: Waqt amministrazzjoni orali ta' 20 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.
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 addominali, dardir kelite, dispepsja, stitikezza, ġinġivite peritonite, pankreatite, ilsien minfuħ, duwodenite, gastroenterite, glossite
English: Immune system disorders hypersensitivity anaphylactoid reaction
Maltese: Disturbi fissistema immuni sensittività eċċessiva reazzjoni anafilaktojda
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 viżiv fit-tul (ara sezzjoni 4.4).
English: Clinical studies examining QTc interval
Maltese: Studji kliniċi li eżaminaw l-intervall QT
English: PVC / Aluminium blister in cartons of 2, 10, 14, 20, 28, 30, 50, 56 or 100 film-coated tablets or unit dose PVC / Aluminium blister in pack sizes of 10x1, 14x1, 28x1, 30x1, 56x1 or 100x1 film-coated tablets.
Maltese: Blister tal-PVC / Aluminium f'daqsijiet ta' pakketti ta' 10x1, 14x1, 28x1, 30x1, 56x1 jew 100x1 pillola miksija b'rita.
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: • Congenital or acquired QTc -prolongation.
Maltese: • Titwil konġenitu jew akkwiżit tal-QTc.
English: Efavirenz (CYP450 inducer; CYP3A4 inhibitor and substrate)
Maltese: Efavirenz (induttur ta' CYP450; inibitur u substrat ta' CYP3A4)
English: Coadministration of voriconazole and high doses of ritonavir (400 mg and above BID) is contraindicated (see section 4.3).
Maltese: dożi għoljin ta' ritonavir (400 mg u aktar BID) hija kontraindikata (ara sezzjoni 4.3).
English: 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: 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 każi disponibbli għall-analiżi minn EUCAST, bħalissa m'hemmx evidenza biżżejjed biex jiġu stabbiliti breakpoints kliniċi għal C. krusei.
English: In addition Voriconazole Accord has been associated with phototoxicity including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria.
Maltese: Barra minn hekk Voriconazole Accord kien assoċjat ma' fototossiċità li tinkludi reazzjonijiet bħal nemex, lentigo, keratożi aktinika u pseudoporphyria.
English: N=241
Maltese: Itraconazole N=241
English: High dose (400 mg BID) Low dose (100 mg BID)*
Maltese: Doża baxxa (100 mg BID)*
English: CARTON (Blister pack for 50 mg film-coated tablets - Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100)
Maltese: KARTUNA (Pakkett b'folji għal pilloli miksija b'rita ta' 50 mg - Pakkett ta' 2, 10, 14, 20, 28, 30,
English: Voriconazole Accord, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:
Maltese: Voriconazole Accord huwa aġent antifungali triazole bi spettru wiesa' li huwa indikat fl-adulti u fit-tfal ta' sentejn jew aktar kif ġej:
English: Voriconazole Accord 200 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Voriconazole Accord #200 mg
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 sa 5 mg/kg BID fil-vina jew minn 200 mg għal 350 mg BID b'mod orali (100 mg sa 200 mg b'mod orali BID f'pazjenti inqas minn 40 kg) (ara sezzjoni
English: Voriconazole Cmax  49% Voriconazole AUCτ  69%
Maltese: Voriconazole Cmax 49% Voriconazole AUC 69%
English: Voriconazole Cmax  34% Voriconazole AUCτ  39%
Maltese: Voriconazole Cmax34% Voriconazole AUC39%
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 class, are listed.
Maltese: Fit-tabella ta' hawn isfel, billi l-maġġoranza tal-istudji kienu ta' natura miftuħa, ir-reazzjonijiet avversi kollha ta' kawżalità u l-kategoriji ta' frekwenza tagħhom f'1,873 adult minn studji terapewtiċi miġburin (1,603) u dwar il-profilassi (270), skont is-sistema tal-klassifika tal-organi, huma elenkati.
English: [CYP2C19 inhibitor; CYP2C19 and CYP3A4 substrate]
Maltese: [inibitur ta' CYP2C19 ; substrat ta' CYP2C19 u CYP3A4]
English: 300 mg QD (coadministered with voriconazole 350 mg BID)*
Maltese: 300 mg QD (amministrat flimkien ma' voriconazole 350 mgBID)*
English: Voriconazole has been shown to be more selective for fungal cytochrome P450 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: Phenytoin Cmax  67% Phenytoin AUCτ  81%
Maltese: Phenytoin Cmax 67% Phenytoin AUC 81% Ikkumparat ma' voriconazole 200 mg BID,
English: The overall incidence of transaminase increases>3xULN (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 f'transaminase 3xULN (li mhux bilfors jinkludu avveniment avvers) filprogramm kliniku ta' voriconazole kienet ta' 18.0% (319/1,768) fl-adulti u 25.
English: Currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta f'sezzjoni 4.8 u 5.1 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: Voriconazole Accord 200 mg film-coated tablets are supplied as white to off white, oval, approximately 15.6 mm in length and 7.8 mm in width, film-coated tablets, debossed with ‘V200' on one side and plain on the other side.
Maltese: Voriconazole Accord 200 mg pilloli miksija b'rita huma fornuti bħala pilloli ovali ta' kulur abjad għal offwajt b'tul ta' madwar 15.6 mm u wiesgħin madwar 7.8 mm b'‘V200' imnaqqxa fuq naħa u n-naħaloħra lixxa.
English: Voriconazole Accord 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Voriconazole Accord #50 mg
English: 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: [potent CYP450 inducer]
Maltese: [induttur qawwi ta' CYP450]
English: • Quinidine (used for irregular heart beat)
Maltese: • Quinidine (użat għaltaħbit tal-qalb irregolari)
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, enċefalopatija4, disturb ekstrapiramidali5, newropatija periferali, atassja, ipoestesija, tibdil fis-sens tat-togħma (dysgeusia)
English: Breakthrough IFI - Day Success at Day 180* * Primary endpoint of study ** Using a margin of 5%, non inferiority is demonstrated ***Difference in proportions, 95% CI obtained after adjustment for randomization Myeloablative conditioning regimens Study endpoints
Maltese: * Punt tat-tmiem primarju tal-istudju ** Użu ta' marġini ta' 5%, tintwera li m'hemmx inferjorità ***Differenza fil-proporzjonijiet, 95% CI miksub wara aġġustament għall-għażla b'mod każwali
English: • Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, delavirdine, nevirapine) (used for treating HIV) (some doses of efavirenz can NOT be taken at the same time as Voriconazole
Maltese: • Non-nucleoside reverse transcriptase inhibitors (p.e., efavirenz, delavirdine, nevirapine)
English: [CYP2C9, CYP2C19 and CYP3A4 inhibitor]
Maltese: [inibitur ta' CYP2C9, CYP2C19 u CYP3A4]
English: Voriconazo le
Maltese: IL-PROVVISTA U L
English: 9 mg/kg twice daily
Maltese: 9 mg/kg kull 12-il siegħa
English: Endocrine disorders adrenal insufficiency, hypothyroidism hyperthyroidis m
Maltese: Disturbi fissistema endokrinarja insuffiċjenza adrenali, ipotirojdiżmu ipertirojdiżmu
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 kutanji severi (SCAR, severe cutaneous adverse reactions) inkluż is-sindrome ta' Stevens-Johnson (SJS, Stevens-Johnson syndrome), nekroliżi epidermika tossika (TEN, toxic epidermal necrolysis), u reazzjoni għall-mediċina b'sintomi ta' eosinofilja u sistemiċi (DRESS, drug reaction with eosinophilia and systemic symptoms), li jistgħu jkunu ta' theddida għall-ħajja jew fatali ġew irrapportati bl-użu ta' voriconazole.
English: Ritonavir (potent CYP450 inducer; CYP3A4 inhibitor and substrate)
Maltese: Ritonavir (induttur qawwi ta' CYP450; inibitur u substrat ta' CYP3A4)
English: Overall, the safety profile of voriconazole in paediatric population was similar to that in adults.
Maltese: B'mod ġenerali, il-profil tas-sigurtà ta' voriconazole fil-popolazzjoni pedjatrika kien simili għal dak tal-adulti.
English: Anticoagulants Warfarin (30 mg single dose, co- administered with 300 mg BID voriconazole)
Maltese: Warfarin (doża waħda ta' 30 mg, amministrata flimkien ma' voriconazole 300 mg BID)
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 efelide, lentigo u keratosi aktinika, speċjalment waqt terapija fuq perjodu fit-tul (ara wkoll sezzjoni 4.4).
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: Seven (3 complete, 4 partial responses) of 17 patients were successfully treated with voriconazole.
Maltese: Sebgħa (3 risponsi sħaħ, 3 parzjali) minn 17-il pazjent kienu kkurati b'suċċess b'voriconazole.
English: Side effects with frequency not known: - Freckles and pigmented spots
Maltese: Effetti sekondarji bi frekwenza mhux magħrufa: - Nemex u tikek pigmentati
English: Voriconazo le (N=125)
Maltese: Punti tat-tmiem tal-istudju Voriconazole (N=125)
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: The efficacy and survival benefit of voriconazole versus conventional amphotericin B in the primary treatment of acute invasive aspergillosis was demonstrated in an open, randomised, multicentre study in 277immunocompromised patients treated for 12 weeks.
Maltese: L-effikaċja u l-vantaġġ għassopravivenza ta' voriconazole mqabbla ma' amphotericin B konvenzjonali fil-kura primarja ta' asperġillosi invażiva akuta kienu murija fi studju miftuħ tat-tip multicentre magħmul b'mod każwali f'277 pazjent immunokompromessi kkurati għal 12-il ġimgħa.
English: Coadministration with ergot alkaloids (ergotamine, dihydroergotamine), which are CYP3A4 substrates, since increased plasma concentrations of these medicinal products can lead to ergotism (see section 4.5).
Maltese: L-amministrazzjoni flimkien ma' alkalojdi ta' l-ergotina (ergotamine, dihydroergotamine), li huma substrati ta' CYP3A4, billi konċentrazzjonijiet akbar ta' dawn il-prodotti mediċinali fil-plasma jistgħu jwasslu għal ergotiżmu (ara sezzjoni 4.5).
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 ħabta u sabta, inkluż imwiet).
English: Children (2 to <12 years) and young adolescents with low body weight (12 to 14 years and <50 kg)
Maltese: Tfal (2 sa <12-il sena) u adoloxxenti żgħar li jiżnu inqas milli suppost (12 sa 14-il sena u <50 kg)
English: [CYP2C9 substrate]
Maltese: [substrat ta' CYP2C9]
English: The species most frequently involved in causing human infections include C. albicans, C. parapsilosis, C.tropicalis, C. glabrata andC.
Maltese: inqas meta mqabbel ma' C. albicans, C. parapsilosis u C. tropicalis.
English: Serious side effects - Stop taking Voriconazole Accord and see a doctor immediately - Rash - Jaundice; Changes in blood tests of liver function - Pancreatitis
Maltese: Effetti sekondarji serji - Tiħux Voriconazole Accord u kellem tabib immedjatament - Raxx - Suffejra; - Bidla fit-testijiet tad-demm jew tal-funzjoni tal-fwied - Pankrejatite
English: [CYP2C9 substrate and potentCYP450 inducer]
Maltese: [substrat ta' CYP2C9 u induttur qawwi ta' CYP450]
English: [CYP2C9 and CYP3A4 substrates]
Maltese: [substrati ta' CYP2C9 u CYP3A4]
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 12to <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: Other proton pump inhibitors that are CYP2C19 substrates may also be inhibited by voriconazole and may result in increased plasma concentrations of these medicinal products.
Maltese: Inibituri oħra tal-proton pump li huma substrati ta' CYP2C19 jistgħu wkoll jiġu inibiti minn voriconazole u jistgħu jirriżultaw f'żieda fil-livelli ta' dawn il-prodotti mediċinali filplażma.
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 flistess waqt bi prodotti mediċinali nefrotossiċi u jkollhom kondizzjonijiet konkorrenti li jistgħu jwasslu għal funzjoni mnaqqsa tal-kliewi (ara sezzjoni 4.8).
English: CARTON (Blister pack for 200 mg film-coated tablets - Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100)
Maltese: KARTUNA (Pakkett b'folji għal pilloli miksija b'rita ta' 200 mg - Pakkett ta' 2, 10, 14, 20, 28,
English: 3 In clinical studies, response to voriconazole in C. krusei infections was similar to C. albicans, C. parapsilosis and C. tropicalis.
Maltese: 3Fi studji kliniċi, ir-rispons għal voriconazole f'infezzjonijiet ta' C. krusei kien simili għal dak ta' C. albicans, C. parapsilosis u C. tropicalis.
English: , leukopenia, anaemia bone marrow failure, lymphadenopathy, eosinophilia disseminated intravascular coagulation
Maltese: Disturbi taddemm u tassistema limfatika agranuloċitożi1, panċitopenja, tromboċitopenja2, lewkopenija, anemija insuffiċjenza talmudullun, limfadenopatija, eosinofilja koagulazzjoni intravaskulari mifruxa
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, kien osservata xejra lejn frekwenza ikbar ta' żidiet fl-enzimi fil-fwied, irrapportati bħal avvenimenti avversi fil-provi kliniċi meta mqabbel mal-adulti (żidiet ta' 14.2% f'transaminases f'pazjenti pedjatriċi meta mqabbel ma' 5.3% fl-adulti).
English: Voriconazole Cmax  18% Voriconazole AUCτ  23%
Maltese: Voriconazole Cmax 18% Voriconazole AUC 23%
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 AUC bejn nisa anzjani b'saħħithom ( 65 sena) u nisa żgħażagħ b'saħħithom (18-45 sena).
English: • Oral contraceptives (if you take Voriconazole Accord whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)
Maltese: • Kontraċettivi orali (jekk tieħu Voriconazole Accord waqt li tkun qed tuża kontraċettivi orali,
English: Efavirenz may be coadministered with voriconazole if the maintenance dose of voriconazole is increased to 400 mg every 12 hours and the efavirenz dose is reduced by 50 %, i.e. to 300 mg once daily.
Maltese: Efavirenz jista jiġi mogħti flimkien ma voriconazole jekk id-doża ta' manteniment ta' voriconazole hija miżjuda għal 400 mg kull 12-il siegħa, u d-doża ta' efavirenz hija mnaqqsa bil-50 %, i.e. għal 300 mg darba kuljum.
English: Ear and labyrinth disorders hypoacusis, vertigo, tinnitus
Maltese: Disturbi filwidnejn u fissistema labirintika ipoakużi, vertigo, żanżin tal-widnejn
English: includingT.
Maltese: MITT.
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 voriconazoletreated 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.