FrancophonIA/ELRC3.0 huggingface dataset:
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.
Hungarian: Barra minn hekk voriconazole juri attività fungiċida in vitro kontra patoġeni fungali emerġenti, fosthom dawk bħal Scedosporium jew Fusarium li għandhom suxxettibilità limitata għal aġenti antifungali eżistenti.
English: 100 mg (2.5 ml) twice daily
Hungarian: 100 mg (2.5 ml) darbtejn kuljum
English: The powder is reconstituted with either 19 ml of water for injections or 19 ml of 9 mg/ml (0.9%) Sodium Chloride for Infusion to obtain an extractable volume of 20 ml of clear concentrate containing 10 mg/ml of voriconazole.
Hungarian: It-trab huwa rikostitwit bi 19 ml tal- ilma għall-injezzjonijiet jew bi 19 ml ta' 9 mg/ml (0.9%) Sodium Chloride għall-Infużjoni sabiex jinkiseb volum li jista' jinġibed ta' 20 ml ta' konċentrat ċar li fih 10 mg/ml ta' voriconazole.
English: PHARMACEUTICAL PARTICULARS
Hungarian: GĦAMLA FARMAĊEWTIKA
English: Coadministration with St. John's Wort (see section 4.5).
Hungarian: John's wort (fexfiex) (ara sezzjoni 4.5).
English: 400 mg (10 ml) every 12 200 mg (5 ml) every 12
Hungarian: 400 mg (10 ml) kull 12il siegħa
English: • Ritonavir (used for treating HIV) in doses of 100 mg twice daily
Hungarian: • Ritonavir (użat għall-kura ta' l-HIV) f'dożi ta' 100 mg u aktar darbtejn kuljum
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).
Hungarian: 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: • Omeprazole (used for treating ulcers)
Hungarian: • Omeprazole (użat għall-kura ta' l-ulċeri)
English: Includes drug-induced liver injury, hepatitis toxic, hepatocellular injury and hepatotoxicity.
Hungarian: Tinkludi korriment tal-fwied ikkaġunat mill-mediċina, epatite tossika, korriment epatoċellulari u tossiċità talfwied.
English: • you are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome'.
Hungarian: • jekk huwa magħruf li għandek kardjomijopatija, taħbit irregolari tal-qalb, taħbit tal-qalb bil-mod jew anormalità ta' l-elettrokardjogramma (ECG) imsejħa ‘sindromu tal-QTc twil'.
English: Other side effects
Hungarian: Effetti sekondarji oħra
English: • Sinus bradycardia.
Hungarian: Siringa waħda
English: Nine subjects in the voriconazole group and 5 in the amphotericin B followed by fluconazole group also had mycologically proven infection in deep tissue.
Hungarian: 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: 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).
Hungarian: L-amministrazzjoni flimkien ma' alkalojdi ta' l-ergotina (ergotamine, dihydroergotamine), li huma sustratti ta' CYP3A4, billi konċentrazzjonijiet akbar ta' dawn il-prodotti mediċinali fil-plasma jistgħu jwasslu għal ergotiżmu (ara sezzjoni 4.5).
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.
Hungarian: Id-doża orali ta' manteniment ta' 300 mg (jew 150 mg għall-pazjenti li l-piż tagħhom huwa anqas minn 40 kg) twassal għal espożizzjoni simili għal dik ta' 4 mg/kg IV.
English: Nervous system disorders headache convulsion, syncope, tremor, hypertonia paraesthesia, somnolence, dizziness brain oedema, encephalopathy extrapyramidal disorder neuropathy peripheral, ataxia, hypoaesthesia, dysgeusia hepatic encephalopathy, Guillain-Barre syndrome, nystagmus
Hungarian: Disturbi fissistema nervuża uġigħ ta' ras konvulżjoni, sinkope, rogħda, ipertonja parasteżija, ngħas, sturdament edima fil-moħħ, enċefalopatija 4, disturb ekstrapiramidali newropatija periferali, atassja, ipoestesija, tibdil fis-sens tat-togħma (dysgeusia)
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Hungarian: Sensittività eċċessiva għas-sustanza attiva jew għal xi eċċipjenti mniżżla f'sezzjoni 6.1.
English: Monitoring for voriconazole-associated adverse reactions is recommended if voriconazole is used sequentially after fluconazole.
Hungarian: Monitoraġġ għal avvenimenti avversi assoċjati ma' voriconazole huwa rrakkomandat jekk voriconazole se jintuża wara fluconazole.
English: Phenytoin may be coadministered with voriconazole if the maintenance dose of voriconazole is increased to 5 mg/kg IV BID or from 200 mg to 400 mg oral BID (100 mg to 200 mg oral BID in patients less than 40 kg) (see section 4.2).
Hungarian: Phenytoin jista' jingħata flimkien ma' voriconazole jekk id-doża ta' manteniment ta' voriconazole tiżdied għal 5 mg/kg fil-vina BID jew minn 200 mg sa 400 mg b'mod orali BID, (100 mg sa 200 mg b'mod orali BID f'pazjenti li jiżnu anqas minn 40 kg) (ara sezzjoni 4.2).
English: 4 mg/kg dose (number of vials)
Hungarian: doża ta' 4 mg/kg (numru ta' kunjetti)
English: In clinical trials there were 3 cases of accidental overdose.
Hungarian: F'testijiet kliniċi kien hemm 3 każijiet ta' doża eċċessiva aċċidentali.
English: Frequent monitoring for adverse reactions and toxicity related to NSAIDs is recommended.
Hungarian: Monitoraġġ frekwenti għal episodji avversi u tossiċità relatati ma' NSAIDs, huwa rrakkomandat.
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.
Hungarian: 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 (↑) mill-medda ta' 80-125%.
English: Oral suspension Patients 40 kg and above Patients less than 40 kg
Hungarian: Suspensjoni orali Pazjenti li jiżnu 40 kg u aktar
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.
Hungarian: 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: 9 mg/kg dose (number of vials)
Hungarian: doża ta' 9 mg/kg (numru ta' kunjetti)
English: Teenagers aged 12 to 14 years weighing 50 kg or more; and all teenagers older than 14
Hungarian: Teenagers ta' bejn 12 u 14-il sena li jiżnu 50 kg jew aktar; u t-teenagers kollha ta' aktar minn 14il sena
English: Non-infectious periostitis with elevated fluoride and alkaline phosphatase levels has been reported in transplant patients.
Hungarian: Kien hemm rapporti ta' perjostite (periostitis) mhux infettiva b'livelli ta' fluoride u alkaline phosphate għoljin f'pazjenti tat-trapjanti.
English: Not for bolus injection
Hungarian: Mhux għal injezzjoni bolus
English: Risk Management Plan (RMP)
Hungarian: • Pjan tal-ġestjoni tar-riskju (RMP)
English: Rifabutin [potent CYP450 inducer]
Hungarian: Rifabutin (induttur qawwi ta' CYP450)
English: Side effects with frequency not known: Freckles and pigmented spots
Hungarian: Effetti sekondarji bi frekwenza mhux magħrufa: - Nemex u tikek pigmentati
English: Interaction Geometric mean changes (%)
Hungarian: Bdil fil-medja ġeometrika talinterazzjoni (%)
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.
Hungarian: f'7.5% (3/40) tal-pazjenti matul l-ewwel sena wara HSCT, inklużi candidemijawaħda, xedosporjożi waħda (it-tnejn kienu irkaduti minn IFIs fil-passat), u żigomikożi waħda.
English: VFEND 200 mg powder and solvent for solution for infusion Powder for solution for infusion: White lyophilised powder.
Hungarian: VFEND 200 mg trab u solvent għal soluzzjoni għall-infużjoni Trab għal soluzzjoni għall-infużjoni: Trab abjad ixxottat bil-friża.
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.
Hungarian: Fl-adoloxxenti l-oħra kollha (12 sa 14-il sena u ≥50 kg; 15 sa 17-il sena irrispettivament mill-piż talġisem) id-doża ta' voriconazole għandha tkun bħal tal-adulti.
English: Excipient with known effect Each bag contains 177.02 mg sodium.
Hungarian: Eċċipjent bl-effett magħruf Kull borża fiha 177.02 mg sodju.
English: VFEND 200 mg powder for solution for infusion:
Hungarian: VFEND 200 mg trab għal soluzzjoni għall-infużjoni:
English: The studies included cerebral, sinus, pulmonary and disseminated aspergillosis in patients with bone marrow and solid organ transplants, haematological malignancies, cancer and AIDS.
Hungarian: L-istudji kienu jinkludu asperġillosi ċerebrali, tas-sinus, pulmonari u mifruxa f'pazjenti bi trapjanti talmudullun u ta' organi solidi, tumuri ematoloġiċi, kanċer u AIDS.
English: • Pimozide (used for treating mental illness)
Hungarian: • Pimozide (użat għall-kura ta' mard mentali)
English: A higher frequency of liver enzyme elevations was observed in the paediatric population (see section 4.8).
Hungarian: Ġiet osservata frekwenza ogħla ta' żidiet ta' enzimi fil-fwied fil-popolazzjoni pedjatrika (ara sezzjoni 4.8).
English: Each tablet contains 50 mg voriconazole.
Hungarian: Kull pillola fiha 50 mg ta' voriconazole.
English: Each tablet contains 50 or 200 mg voriconazole.
Hungarian: Kull pillola fiha 50 jew 200 mg ta' voriconazole.
English: EXP Shelf life after reconstitution: 24 hours when stored at 2°C - 8°C.
Hungarian: Żmien kemm idum tajjeb il-prodott wara rikostituzzjoni: 24 siegħa meta maħżun f'temperatura ta' 2C - 8C.
English: 18.UNIQUE IDENTIFIER - HUMAN READABLE DATA
Hungarian: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: Reconstituted VFEND concentrate needs to be further diluted with sodium chloride (0.9%) infusion solution within the infusion bag before it is infused.
Hungarian: Il-konċentrat ta' VFEND irrikostitwit irid jiġi dilwit aktar b'soluzzjoni għal infużjoni ta' sodium chloride (0.9%) fil-borża tal-infużjoni qabel ma jiġi infuż.
English: ANNEX II
Hungarian: ANNESS II
English: VFEND 200 mg powder and solvent for solution for infusion:
Hungarian: VFEND 200 mg trab u solvent għal soluzzjoni għall-infużjoni:
English: VFEND, is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:
Hungarian: VFEND, huwa aġent antifungali triazole bi spettru wiesa' li huwa indikat fl-adulti u fit-tfal ta' sentejn jew aktar kif ġej:
English: Severe cutaneous adverse reactions (SCARs) such as 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.
Hungarian: Reazzjonijiet avversi severi tal-ġilda (SCARs, severe cutaneous adverse reactions) bħal 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: Hair loss
Hungarian: Bijotrasformazzjoni
English: VFEND tablets contain lactose and should not be given to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Hungarian: Il-pilloli VFEND fihom il-lattosju u m'għandhomx jingħataw lil pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew assorbiment ħażin tal-glukosju-galactose.
English: Each bottle contains 45 g of powder providing 70 ml of suspension when constituted with water as recommended.
Hungarian: Kull flixkun fih 45 g trab li jipprovdu 70 ml ta' suspensjoni meta jiġu kostitwiti bl-ilma kif rakkomandat.
English: Voriconazole is rapidly and almost completely absorbed following oral administration, with maximum plasma concentrations (Cmax) achieved 1-2 hours after dosing.
Hungarian: Voriconazole huwa assorbit malajr u kważi kompletament wara amministrazzjoni orali, b'konċentrazzjonijiet massimi fil-plasma (Cmax) jinkisbu siegħa sa sagħtejn wara d-doża.
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.
Hungarian: Scedosporium spp.: 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: • candidaemia (another type of fungal infection due to Candida sp) in non-neutropenic patients (patients without abnormally low white blood cells count),
Hungarian: • candidaemia (tip ieħor ta' infezzjoni fungali minħabba Candida sp) f'pazjenti li m'għandomx newtropenja (pazjenti li m'għandhomx għadd ta' ċelloli bojod tad-demm baxx mhux normali),
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).
Hungarian: Opiates li jaħdmu għal ħin qasir (sustratt CYP3A4) 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: 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).
Hungarian: 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: 8, drug reaction with eosinophilia and systemic symptoms (DRESS) angioedema, actinic keratosis*, pseudoporphyria , erythema multiforme, psoriasis, drug eruption cutaneous lupus erythemato sus*, ephelides*, lentigo*
Hungarian: 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: Reporting of suspected adverse reactions
Hungarian: Rappurtar ta' reazzjonijiet avversi suspettati
English: 6 mg/kg dose (number of vials)
Hungarian: doża ta' 6 mg/kg (numru ta' kunjetti)
English: Infections and infestations sinusitis pseudomembranous colitis
Hungarian: Infezzjonijiet u infestazzjoniji et sinusite kolite psewdomembranuż
English: Itchiness
Hungarian: Anzjani
English: Four additional patients with fusariosis had an infection caused by several organisms; 2 of them had a successful outcome.
Hungarian: Erba' pazjenti oħra b'fusariosis kellhom infezzjoni kkawżata minn diversi organiżmi; 2 minnhom kellhom eżitu ta' suċċess.
English: The inter-individual variability of voriconazole pharmacokinetics is high.
Hungarian: Il-varjabilità tal-farmakokinetika ta' voriconazole bejn individwi differenti hija għolja.
English: Voriconazole N=224
Hungarian: Punti tat-Tmiem tal-Istudju Voriconazole N=224
English: In clinical studies, response to voriconazole in C. krusei infections was similar to C. albicans, C. parapsilosis and C. tropicalis.
Hungarian: Fi studji kliniċi, ir-rispons għal voriconazole f'infezzjonijiet ta' C. krusei kien simili għal dak ta' C. albicans, C. parapsilosis u C. tropicalis.
English: After reconstitution each ml contains 10 mg of voriconazole.
Hungarian: Wara rikostituzzjoni, kull ml fih 10 mg ta' voriconazole.
English: VFEND 200 mg powder for solution for infusion voriconazole
Hungarian: VFEND 200 mg trab għal soluzzjoni għal infużjoni Voriconazole
English: Each tablet contains either 50 mg voriconazole (for VFEND 50 mg film-coated tablets) or 200 mg voriconazole (for VFEND 200 mg film-coated tablets).
Hungarian: Kull pillola fiha 50 mg (għal VFEND 50mg pilloli miksija b'rita) jew 200mg (għal VFEND 200mg pilloli miksija b'rita) ta' voriconazole.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Hungarian: Dwar il-kondizzjonijiet għall-ħażna tal-prodott mediċinali wara r-rikostituzzjoni, ara sezzjoni 6.3.
English: Label on the vial
Hungarian: Kartuna ta' barra
English: Fifty-three paediatric patients aged 2 to <18 years were treated with voriconazole in two prospective, openlabel, non-comparative, multi-center clinical trials.
Hungarian: Tlieta u ħamsin pazjenti tfal ta' bejn is-sentejn u <18-il sena ġew ikkurati b'voriconazole f'żewġ provi kliniċi prospettivi, open-label, mhux komparattivi, multiċentriċi.
English: • The VFEND powder is reconstituted by using the specially marked syringe provided to remove 19 ml of VFEND solvent for solution for infusion (Sodium Chloride (0.9%) from the blue port of the infusion bag.
Hungarian: • It-trab VFEND jiġi rikostitwit billi tintuża s-siringa mmarkata apposta pprovduta biex tneħħi 19 ml ta' VFEND solvent għal soluzzjoni għall-infużjoni (Sodium Chloride (0.9%) mill-port blu tal-borża tal-infużjoni.
English: • Exfoliative cutaneous reactions
Hungarian: • Reazzjonijiet esfoljativi tal-ġilda
English: • It is recommended that a standard 20 ml (non-automated) syringe be used to ensure that the exact amount (19.0 ml) of Water for Injections or of 9 mg/ml (0.9%) Sodium Chloride for Infusion is dispensed.
Hungarian: • Huwa rakkomandat li tintuża siringa standard ta' 20 ml (mhux awtomatika) sabiex jiġi żgurat li jingħata l-ammont eżatt (19.0 ml) ta' Ilma għall-Injezzjonijiet jew ta' 9 mg/ml (0.9%) Sodium Chloride għall-Infużjoni.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Hungarian: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: If phototoxic reactions occur multidisciplinary advice should be sought, VFEND discontinuation and use of alternative antifungal agents should be considered and the patient should be referred to a dermatologist.
Hungarian: Jekk ikun hemm reazzjonijiet fototossiċi għandu jittieħed parir multidixxiplinari, it-twaqqif ta' VFEND u l-użu ta' mediċini antifungali alternattivi għandu jiġi kkunsidrat u l-pazjent għandu jintbagħat għand dermatologu.
English: The safety profile and plasma concentrations observed in male and female patients were similar.
Hungarian: Il-profil tas-sigurtà u lkonċentrazzjonijiet fil-plasma osservati f'pazjenti rġiel u nisa kienu simili.
English: There is no known antidote to voriconazole.
Hungarian: M'hemmx antidotu magħruf għal voriconazole.
English: VFEND 200 mg powder for solution for infusion Each vial contains 200 mg of voriconazole.
Hungarian: VFEND 200 mg trab għal soluzzjoni għall-infużjoni Kull kunjett fih 200 mg ta' voriconazole.
English: Duration of treatment
Hungarian: Trattament fit-tul
English: No clinically significant differences were seen when the safety data were analysed by age, race, or gender.
Hungarian: Ebda differenzi klinikament sinifikanti ma kienu jidhru meta d-dejta tas-sigurtà ġiet analizzata skont l-età, razza jew sess.
English: • Once the syringe is reconnected to the blue port of the infusion bag, the contents are then emptied into the infusion bag from the syringe to provide a final voriconazole solution containing 0.5-5 mg/ml.
Hungarian: • Ladarba s-siringa tkun tqabbdet mil-ġdid mal-port blu tal-borża tal-infużjoni, imbagħad ilkontenut jitbattal ġol-borża tal-infużjoni minn ġos-siringa sabiex jipprovdi soluzzjoni finali ta' voriconazole li jkun fiha 0.5-5 mg/ml.
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.
Hungarian: 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: Cardiovascular
Hungarian: Pożoloġija
English: Infuse at a maximum rate of 3 mg/kg per hour.
Hungarian: Erħi b'rata massima ta' 3mg/kg fis-siegħa.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Hungarian: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi ssuspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: Rare: may affect up to 1 in 1000 people
Hungarian: Rari: jistgħu jaffetwaw sa 1 kull 1,000 pazjent
English: In addition VFEND has been associated with phototoxicity including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria.
Hungarian: Barra minn hekk VFEND kien assoċjat ma' fototossiċità, li tinkludi reazzjonijiet bħal nemex, lentigo, keratożi aktinika u pseudoporphyria.
English: Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.
Hungarian: Profilassi ta' infezzjonijiet fungali invażivi f'riċevituri alloġeniċi f'riskju għoli ta' trapjant ta' ċelluli imsejħa stem fid-demm (HSCT).
English: Photosensitivity reactions such as ephelides, lentigo and actinic keratosis have been reported, especially during long-term therapy (see section 4.4).
Hungarian: Kienu rrapportati reazzjonijiet ta' fotosensittività bħal nemex, lentigo u keratożi aktinika, speċjalment waqt terapija fuq perjodu fit-tul (ara sezzjoni 4.4).
English: VFEND 50 mg film-coated tablets
Hungarian: VFEND 50 mg pilloli miksijin b'rita
English: Coadministration with sirolimus since voriconazole is likely to increase plasma concentrations of sirolimus significantly (see section 4.5).
Hungarian: L-amministrazzjoni flimkien ma' sirolimus billi voriconazole huwa probabbli li jżid ilkonċentrazzjonijiet fil-plasma ta' sirolimus b'mod sinifikanti (ara sezzjoni 4.5).
English: Rash
Hungarian: Sess
English: Solvent for VFEND powder for solution for infusion Sodium Chloride 0.9% in Water for Injections Intravenous use
Hungarian: Solvent għal VFEND trab għal soluzzjoni għall-infużjoni Sodium Chloride 0.9% fl-Ilma għall-Injezzjonijiet Użu ġol-vini
English: Dosage adjustment (Children [2 to <12 years] and young adolescents with low body weight [12 to 14 years and <50 kg])
Hungarian: Tfal (2 sa <12-il sena) u adoloxxenti żgħar li jiżnu inqas milli suppost (12 sa 14-il sena u <50 kg).
English: Renal and urinary disorders renal failure acute, haematuria renal tubular necrosis, proteinuria, nephritis
Hungarian: Disturbi filkliewi u fissistema urinarja insuffiċjenza talkliewi akuta, ematurja nekrosi tubulari talkliewi, proteinurja, nefrite
English: Infusion-related reactions
Hungarian: Reazzjonijiet relatati mal-infużjoni
English: VFEND 50 mg film-coated tablets voriconazole
Hungarian: VFEND 50 mg pilloli miksijin b'rita voriconazole