FrancophonIA/ELRC3.0 huggingface dataset:
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.
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: 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 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.
Maltese: 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
Maltese: 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: Monitoring for voriconazole-associated adverse reactions is recommended if voriconazole is used sequentially after fluconazole.
Maltese: Monitoraġġ għal avvenimenti avversi assoċjati ma' voriconazole huwa rrakkomandat jekk voriconazole se jintuża wara fluconazole.
English: (Cyprus Branch)
Maltese: Pfizer ΕΛΛΑΣ Α.Ε. (Cyprus Branch)
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Dwar il-kondizzjonijiet għall-ħażna tal-prodott mediċinali wara r-rikostituzzjoni, ara sezzjoni 6.3.
English: Rifabutin [potent CYP450 inducer]
Maltese: Rifabutin (induttur qawwi ta' CYP450)
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: 4 mg/kg dose (number of vials)
Maltese: doża ta' 4 mg/kg (numru ta' kunjetti)
English: Oral suspension Patients 40 kg and above Patients less than 40 kg
Maltese: Suspensjoni orali Pazjenti li jiżnu 40 kg u aktar
English: 9 mg/kg dose (number of vials)
Maltese: 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
Maltese: Teenagers ta' bejn 12 u 14-il sena li jiżnu 50 kg jew aktar; u t-teenagers kollha ta' aktar minn 14il sena
English: Not for bolus injection
Maltese: Mhux għal injezzjoni bolus
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-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.
Maltese: Eċċipjent bl-effett magħruf Kull borża fiha 177.02 mg sodju.
English: VFEND 200 mg powder for solution for infusion:
Maltese: 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.
Maltese: 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: Frequent monitoring for adverse reactions and toxicity related to NSAIDs is recommended.
Maltese: Monitoraġġ frekwenti għal episodji avversi u tossiċità relatati ma' NSAIDs, huwa rrakkomandat.
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.
Maltese: 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 tablet contains 50 mg voriconazole.
Maltese: Kull pillola fiha 50 mg ta' voriconazole.
English: Each tablet contains 50 or 200 mg voriconazole.
Maltese: Kull pillola fiha 50 jew 200 mg ta' voriconazole.
English: EXP Shelf life after reconstitution: 24 hours when stored at 2°C - 8°C.
Maltese: Żmien kemm idum tajjeb il-prodott wara rikostituzzjoni: 24 siegħa meta maħżun f'temperatura ta' 2C - 8C.
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 (↑) mill-medda ta' 80-125%.
English: VFEND, is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:
Maltese: VFEND, huwa aġent antifungali triazole bi spettru wiesa' li huwa indikat fl-adulti u fit-tfal ta' sentejn jew aktar kif ġej:
English: Reconstituted VFEND concentrate needs to be further diluted with sodium chloride (0.9%) infusion solution within the infusion bag before it is infused.
Maltese: 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: VFEND 200 mg powder and solvent for solution for infusion:
Maltese: VFEND 200 mg trab u solvent għal soluzzjoni għall-infużjoni:
English: Side effects with frequency not known: Freckles and pigmented spots
Maltese: Effetti sekondarji bi frekwenza mhux magħrufa: - Nemex u tikek pigmentati
English: Hair loss
Maltese: Bijotrasformazzjoni
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.
Maltese: 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: Each bottle contains 45 g of powder providing 70 ml of suspension when constituted with water as recommended.
Maltese: 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.
Maltese: Voriconazole huwa assorbit malajr u kważi kompletament wara amministrazzjoni orali, b'konċentrazzjonijiet massimi fil-plasma (Cmax) jinkisbu siegħa sa sagħtejn wara d-doża.
English: • candidaemia (another type of fungal infection due to Candida sp) in non-neutropenic patients (patients without abnormally low white blood cells count),
Maltese: • 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: 6 mg/kg dose (number of vials)
Maltese: doża ta' 6 mg/kg (numru ta' kunjetti)
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: Itchiness
Maltese: Anzjani
English: Voriconazole N=224
Maltese: Punti tat-Tmiem tal-Istudju Voriconazole N=224
English: After reconstitution each ml contains 10 mg of voriconazole.
Maltese: Wara rikostituzzjoni, kull ml fih 10 mg ta' voriconazole.
English: Long term exposure to voriconazole greater than 180 days (6 months) requires careful assessment of the benefit-risk balance (see sections 4.4 and 5.1).
Maltese: Esponiment fit-tul għal voriconazole li jkun aktar minn 180 jum (6 xhur) jeħtieġ evalwazzjoni b'attenzjoni tal-bilanċ benefiċċju-riskju (ara sezzjonijiet 4.4 u 5.1).
English: VFEND 200 mg powder for solution for infusion voriconazole
Maltese: VFEND 200 mg trab għal soluzzjoni għal infużjoni Voriconazole
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*
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: 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).
Maltese: Kull pillola fiha 50 mg (għal VFEND 50mg pilloli miksija b'rita) jew 200mg (għal VFEND 200mg pilloli miksija b'rita) ta' voriconazole.
English: Label on the vial
Maltese: Kartuna ta' barra
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.
Maltese: • 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: • 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.
Maltese: • 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: 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.
Maltese: 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.
Maltese: Il-profil tas-sigurtà u lkonċentrazzjonijiet fil-plasma osservati f'pazjenti rġiel u nisa kienu simili.
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: VFEND 200 mg powder for solution for infusion Each vial contains 200 mg of voriconazole.
Maltese: VFEND 200 mg trab għal soluzzjoni għall-infużjoni Kull kunjett fih 200 mg ta' voriconazole.
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 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: Infuse at a maximum rate of 3 mg/kg per hour.
Maltese: Erħi b'rata massima ta' 3mg/kg fis-siegħa.
English: Rare: may affect up to 1 in 1000 people
Maltese: Rari: jistgħu jaffetwaw sa 1 kull 1,000 pazjent
English: Four additional patients with fusariosis had an infection caused by several organisms; 2 of them had a successful outcome.
Maltese: Erba' pazjenti oħra b'fusariosis kellhom infezzjoni kkawżata minn diversi organiżmi; 2 minnhom kellhom eżitu ta' suċċess.
English: In addition VFEND has been associated with phototoxicity including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria.
Maltese: Barra minn hekk VFEND kien assoċjat ma' fototossiċità, li tinkludi reazzjonijiet bħal nemex, lentigo, keratożi aktinika u pseudoporphyria.
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: VFEND 50 mg film-coated tablets
Maltese: 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).
Maltese: L-amministrazzjoni flimkien ma' sirolimus billi voriconazole huwa probabbli li jżid ilkonċentrazzjonijiet fil-plasma ta' sirolimus b'mod sinifikanti (ara sezzjoni 4.5).
English: Solvent for VFEND powder for solution for infusion Sodium Chloride 0.9% in Water for Injections Intravenous use
Maltese: 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])
Maltese: Tfal (2 sa <12-il sena) u adoloxxenti żgħar li jiżnu inqas milli suppost (12 sa 14-il sena u <50 kg).
English: Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.
Maltese: Profilassi ta' infezzjonijiet fungali invażivi f'riċevituri alloġeniċi f'riskju għoli ta' trapjant ta' ċelluli imsejħa stem fid-demm (HSCT).
English: VFEND 50 mg film-coated tablets voriconazole
Maltese: VFEND 50 mg pilloli miksijin b'rita voriconazole
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 sustratti ta' CYP2C19 jistgħu wkoll jiġu inibiti minn voriconazole u jistgħu jirriżultaw f'żieda fillivelli ta' dawn il-prodotti mediċinali fil-plażma.
English: • Squamous cell carcinoma of the skin (SCC)
Maltese: • Reazzjonijiet avversi dermatoloġiċi serji (inkluż SCC)
English: Infusion-related reactions, predominantly flushing and nausea, have been observed during administration of the intravenous formulation of voriconazole.
Maltese: Reazzjonijiet relatati ma' l-infużjoni, predominantament fwawar u dardir, ġew osservati matul amministrazzjoni tal-formolazzjoni ġol-vini ta' voriconazole.
English: Each tablet contains 200 mg voriconazole.
Maltese: Kull pillola fiha 200 mg ta' voriconazole.
English: How to take VFEND
Maltese: X'fih VFEND
English: Visual impairments
Maltese: Indebolimenti viżwali
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.
Maltese: • 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: Currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.
Maltese: Id-dejta disponibbli bħalissa hija deskritta f'sezzjoni 4.8 u 5.1, iżda ma tista' ssir l-ebda rakkomandazzjoni dwar il-pożoloġija.
English: 200 mg (5 ml) every 12 hours
Maltese: 200 mg (5 ml) darbtejn kuljum
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 (9 mg/ml [0.9%]) Sodium Chloride for Infusion is dispensed.
Maltese: Huwa rakkomandat li tintuża siringa standard ta' 20 ml (mhux awtomatika) sabiex jiġi żgurat li jingħata l-ammont eżatt (19.0 ml) tal-ilma għall-injezzjonijiet jew (9 mg/ml [0.9%]) ta' Sodium Chloride għall-Infużjoni.
English: VFEND 200 mg film-coated tablets
Maltese: VFEND 200 mg pilloli miksijin b'rita
English: Although not studied clinically, voriconazole is likely to increase the plasma concentrations of statins that are metabolised by CYP3A4 and could lead to rhabdomyolysis.
Maltese: Għalkemm mhux studjat klinikament, voriconazole jista' jżid il-livelli tas-statins fil-plażma li huma metabolizzati minn CYP3A4 u jista' jwassal għal rhabdomyolysis.
English: Duration of treatment
Maltese: Trattament fit-tul
English: 1 sterile, single use vial adapter.
Maltese: 1 adapter tal-kunjett sterili, li jintuża darba biss.
English: Eye disorders visual impairment retinal haemorrhage optic nerve disorder papilloedema oculogyric crisis, diplopia, scleritis, blepharitis optic atrophy, corneal opacity
Maltese: 8, kriżi okuloġirika, tara doppju, sklerite, blefarite atrofija ottika, opaċità talkornea
English: How to store VFEND
Maltese: Kif gћandek tieћu VFEND
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 candidemija waħda, xedosporjożi waħda (it-tnejn kienu irkaduti minn IFIs fil-passat), u żigomikożi waħda.
English: • Oral contraceptives (if you take VFEND whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)
Maltese: • Kontraċettivi orali (jekk tieħu VFEND waqt li tkun qed tuża kontraċettivi orali, jista' jkollok effetti mhux mixtieqa bħal dardir u disturbi mestrwali)
English: This study confirmed findings from an earlier, prospectively designed study where there was a positive outcome in subjects with risk factors for a poor prognosis, including graft versus host disease, and, in particular, cerebral infections (normally associated with almost 100% mortality).
Maltese: Dan l-istudju kkonferma sejbiet minn studju preċedenti, mfassal b'mod prospettiv fejn kien hemm eżitu pożittiv f'suġġetti b'fatturi ta' riskju għal pronjosi fqira, fosthom graft versus host disease, u b'mod partikolari, infezzjonijiet ċerebrali (normalment assoċjati ma' kważi 100% mortalità).
English: Hepatobiliary disorders liver function test abnormal jaundice, jaundice cholestatic, hepatitis hepatic failure, hepatomegaly, cholecystitis, cholelithiasis
Maltese: Disturbi filfwied u filmarrara test tal-funzjoni tal-fwied b'riżultat anormali suffejra, suffejra kolestatika, epatite insuffiċjenza talfwied, epatomegalija, koleċistite, cholelithiasis
English: Bottle
Maltese: Kunjett
English: Vivian Corporation Ltd. Tel : +356 21344610
Maltese: Tel : +356 21344610
English: Median duration of IV voriconazole therapy was 10 days (range 2-85 days).
Maltese: It-terapija b'voriconazole IV damet għal medja ta'għaxart ijiem (medda ta' 2-85 ġurnata).
English: This represents a heterogeneous population, containing patients with haematological malignancy, HIV-infected patients with oesophageal candidiasis and refractory fungal infections, non-neutropenic patients with candidaemia or aspergillosis and healthy volunteers.
Maltese: Din tirrappreżenta popolazzjoni eteroġenea, li tinkludi pazjenti b'tumuri ematoloġiċi, pazjenti infettati bl-HIV b'candidiasis esofagali u infezzjonijiet fungali refrettarji, pazjenti mhux newtropeniċi b'candidaemia jew asperġillosi u voluntiera b'saħħithom.
English: Intravenous 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 jiżnu anqas minn 50 kg
English: Coadministration of voriconazole with everolimus is not recommended because voriconazole is expected to significantly increase everolimus concentrations (see section 4.4).
Maltese: Amministrazzjoni ta' voriconazole flimkien ma' everolimus mhuwiex irrakkomandat għaliex voriconazole huwa mistenni li jżid sinifikament ilkonċentrazzjonijiet ta' everolimus (ara sezzjoni 4.4).
English: Patients 40 kg and above*
Maltese: Orali Pazjenti li jiżnu 40 kg u aktar*
English: VFEND 200 mg film-coated tablets voriconazole
Maltese: VFEND 200 mg pilloli miksijin b'rita voriconazole
English: In clinical studies, response to voriconazole in C. krusei infections was similar to C. albicans, C. parapsilosis and C. tropicalis.
Maltese: 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: - Reminds HCPs to discuss with the patient/care giver the risks of phototoxicity/skin SCC and hepatotoxicity, what to look for, how and when to seek immediate attention.
Maltese: - Ifakkar lil HCPs biex jiddiskutu mal-pazjent/il-persuna li tieħu ħsieb il-pazjent dwar irriskji ta' fototossiċità/SCC tal-ġilda u tossiċità tal-fwied, x'għandek tinnota, kif u meta tfittex attenzjoni immedjata.
English: However, if the combination is strictly needed, the maintenance dose of voriconazole may be increased from 200 mg to 350 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see sections 4.4 and 4.5.
Maltese: Madankollu, jekk il-kombinazzjoni tkun strettament meħtieġa, id-doża ta' manteniment ta' voriconazole tista' tiżdied minn 200 mg għal 350 mg b'mod orali, darbtejn kuljum (bejn 100 mg u 200 mg b'mod orali, darbtejn kuljum f'pazjenti li jiżnu inqas minn 40 kg), ara sezzjonijiet 4.4 u 4.5.
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 jaħdmu fuq qasir żmien bi struttura simili għal alfentanil u metabolizzati minn CYP3A4
English: Plasma protein binding is estimated to be 58%.
Maltese: It-twaħħil mal-proteini tal-plasma huwa stmat għal 58%.
English: • Ritonavir (used for treating HIV) in doses of 400mg and more twice daily
Maltese: • Ritonavir (użat għall-kura ta' l-HIV) f'dożi ta' 400 mg u aktar darbtejn kuljum