FrancophonIA/ELRC3.0 huggingface dataset:
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: • Pimozide (used for treating mental illness)
Maltese: • Pimozide (użat għall-kura ta' mard mentali)
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 277 immunocompromised patients treated for 12 weeks.
Maltese: L-effikaċja u l-vantaġġ għassopravivenza ta' voriconazole imqabbla 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: A comparison of the paediatric and adult population pharmacokinetic data indicated that the predicted total exposure (AUCτ) in children following administration of a 9 mg/kg IV loading dose was comparable to that in adults following a 6 mg/kg IV loading dose.
Maltese: Paragun tad-dejta farmakokinetika fit-tfal u fl-adulti indika li l-esponiment totali (AUCτ) imbassar fit-tfal wara amministrazzjoni ta' doża inizjali fil-vina aktar qawwija ta' 9 mg/kg kien kumparabbli ma' dak tal-adulti wara amministrazzjoni ta' doża inizjali fil-vina aktar qawwija ta' 6 mg/kg.
English: • You are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome'.
Maltese: • 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: Visual impairments
Maltese: Indebolimentiviżwali
English: Hepatic toxicity
Maltese: GĦAMLA FARMAĊEWTIKA
English: BN
Maltese: AML
English: Voriconazole Hikma has a moderate influence on the ability to drive and use machines.
Maltese: Voriconazole huwa assorbit malajr u kważi kompletament wara amministrazzjoni orali,
English: Voriconazole Hikma requires reconstitution and dilution (see section 6.6) prior to administration as an intravenous infusion.
Maltese: Voriconazole Hikma jeħtieġ rikostituzzjoni u dilwizzjoni (ara sezzjoni 6.6) qabel jingħata bħala infużjoni fil-vini.
English: Co-administration 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 il-konċentrazzjonijiet fil-plażma ta' sirolimus b'mod sinifikanti (ara sezzjoni 4.5).
English: • Health Care Professional (HCP) Checklist for Phototoxicity, SCC and Hepatic toxicity: - Reminds HCPs of the risks of phototoxicity, skin SCC and hepatotoxicity reported with voriconazole use.
Maltese: • Il-Lista ta' Verifiċi ta' Professjonisti fil-Qasam tal-Kura tas-Saħħa (HCPs) għal Fototossiċità, SCC tal-ġilda u Tossiċità tal-Fwied: - Għandu jfakkar lil HCPs dwar ir-riskji ta' fototossiċità, SCC tal-ġilda u epatotossċità rapportata waqt l-użu b'voriconazole.
English: For Caucasians and Blacks the prevalence of poor metabolisers is 3-5 %.
Maltese: Fil-każ tal-Kawkasi u s-Suwed il-prevalenza ta' metabolizzaturi ħżiena hija 3-5 %.
English: • Overactive thyroid gland
Maltese: • Glandola tat-tirojde attiva ħafna
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 adolexxenti żgħar li jiżnu inqas milli suppost (12 sa 14-il sena u <50 kg).
English: • Ritonavir (used for treating HIV) in doses of 100 mg twice daily
Maltese: • Ritonavir (użat għall-kura ta' l-HIV) f'dożi ta' 100 mg u aktar darbtejn kuljum
English: Patients have developed severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) (uncommon), toxic epidermal necrolysis (TEN) (rare), drug reaction with eosinophilia and systemic symptoms (DRESS) (rare) and erythema multiforme (rare) during treatment with voriconazole (see section 4.4).
Maltese: Il-maġġoranza tar-raxxijiet kienu ta' severità ħafifa għal moderata Ilpazjenti żviluppaw reazzjonijiet avversi kutanjiseveri (SCARs, severe cutaneous adverse reactions), inkluż is-sindromu ta' Stevens-Johnson (SJS) (mhux komuni), nekroliżi epidermika tossika (TEN, toxic epidermal necrolysis) (rari) reazzjoni għall-mediċina b'sintomi ta' esinofilja u sistemiċi (DRESS) (rari) u eritema multiformi (rari) waqt kura b'voriconazole (ara sezzjoni 4.4).
English: • Health Care Professional (HCP) Question and Answer Brochure for Phototoxicity, SCC and
Maltese: • Il-Kard t'Allert għal Fototossiċità u SCC:
English: No clinically significant differences were seen when the safety data were analysed by age, race, or gender.
Maltese: Ebda differenzi klinikament sinifikanti ma kienu jidhru meta d-dejta tas-sigurtà ġiet analizzata skont l-età, razza jew sess.
English: : Seven (3 complete, 4 partial responses) of 17 patients were successfully treated with voriconazole.
Maltese: Sebgħa (3 risponsi sħaħ, 4 parzjali) minn 17-il pazjent kienu kkurati b'suċċess b'voriconazole.
English: An impurity, present in SBECD, has been shown to be an alkylating mutagenic agent with evidence for carcinogenicity in rodents.
Maltese: Impurità, preżenti f'SBECD, intweriet li kienet aġent mutaġeniku alkalitiku b'evidenza għal karċinoġeniċità f'annimali gerriema.
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 riżultati 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: It is likely that these subjects may metabolize voriconazole more similarly to children than to adolescents/adults.
Maltese: Probabilment dawn il-suġġetti jimmetabolizzaw voriconazole b'mod aktar simili tat-tfal milli dak tal-adolexxenti/adulti.
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: Use of voriconazole in prophylaxis for greater than 180 days (6 months) requires careful assessment of the benefit-risk balance (see sections 4.4 and 5.1).
Maltese: L-użu ta' voriconazole fi profilassi għal aktar minn 180 jum (6 xhur) jeħtieġ evalwazzjoni b'attenzjoni tal-bilanċ ta' bejn il-benefiċċju u r-riskju (ara sezzjonijiet 4.4 u 5.1).
English: • Cisapride (used for stomach problems)
Maltese: • Cisapride (użat għal problemi ta' l-istonku)
English: NAME OF THE MEDICINAL PRODUCT Voriconazole Hikma 200 mg powder for solution for infusion Voriconazole
Maltese: TAL-PRODOTT MEDIĊINALI Voriconazole Hikma 200 mg trab għal soluzzjoni għall-infużjoni Voriconazole
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: In rats, mice and dogs, voriconazole also induced minimal adrenal changes.
Maltese: Fil-firien, ġrieden u klieb, voriconazole kkawża wkoll bidliet adrenali minimi.
English: In a study in healthy volunteers investigating the impact of voriconazole on retinal function, voriconazole caused a decrease in the electroretinogram (ERG) waveform amplitude.
Maltese: Fi studju fost voluntiera b'saħħithom li eżamina l-impatt ta' voriconazole fuq il-funzjoni tarretina, voriconazole kkawża tnaqqis fl-electroretinogram (ERG) waveform amplitude.
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 ta' statins fil-plażma li huma metabolizzati minn CYP3A4 u jista' jwassal għal rabdomijoliżi.
English: Frequent monitoring for adverse reactions and toxicity related to methadone, including QTc prolongation, is recommended when co-administered with voriconazole since methadone levels increased following coadministration of voriconazole.
Maltese: Huwa rrakkomandat monitoraġġ frekwenti għal reazzjonijiet avversi u tossiċità marbuta malmethadone, inkluż titwil tal-QTc, meta l-methadone jiġi amministrat flimkien ma' voriconazole billi llivelli tal-methadone żdiedu wara li ngħata flimkien ma' voriconazole.
English: IFI while on study drug * Primary endpoint of the study ** Difference in proportions, 95% CI and p-values obtained after adjustment for randomization
Maltese: * Ir-rata tat-tmiem primarju tal-istudju ** Differenza fil-proporzjonijiet, 95% CI u valuri p miksuba wara aġġustament għall-għażla b'mod każwali.
English: • Ritonavir (used for treating HIV) in doses of 400 mg and more twice daily
Maltese: • Ritonavir (użat għall-kura ta' HIV) f'dożi ta' 400 mg u aktar darbtejn kuljum
English: For patients less than 40 kg the oral dose may be increased to 150 mg twice daily.
Maltese: Għal pazjenti li jiżnu inqas minn 40 kg id-doża orali tista' tiżdied għal 150 mg darbetjn kuljum.
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 tal-mudullun u ta' organi solidi, tumuri ematoloġiċi, kanċer u AIDS.
English: The required volume of the reconstituted concentrate is then added to a recommended compatible infusion solution listed below to obtain a final Voriconazole Hikma solution containing 0.5 to 5 mg/ml of voriconazole.
Maltese: Il-volum meħtieġ tal-konċentrat rikostitwit imbagħad jiġi miżjud ma' infużjoni kompatibbli rakkomandata għal infużjoni msemmija hawn isfel biex tinkiseb soluzzjoni finali ta' Voriconazole Hikma li jkun fiha 0.5 sa 5 mg/ml ta' voriconazole.
English: Co-administration of voriconazole with everolimus is not recommended because voriconazole is expected to significantly increase everolimus concentrations (see section 4.4).
Maltese: Amministrazzjoni ta' voriconazole ma' everolimus mhix rakkomandata għaliex voriconazole mistenni li jżid sinifikament il-konċentrazzjoni ta' everolimus (ara sezzjoni 4.4).
English: Primary Prophylaxis of Invasive Fungal Infections - Efficacy in HSCT recipients without prior proven or probable IFI
Maltese: Profilassi Primarja ta' Infezzjonijiet Fungali Invażivi - Effikaċja f'riċevituri ta' HSCT mingħajr IFIs li ġew ikkonfermati jew li setgħu fil-passat.
English: When voriconazole treatment is stopped, the initial dose of efavirenz should be restored (see section 4.2 and 4.4).
Maltese: Meta ttrattament b'voriconazole jitwaqqaf, id-doża tal-bidu ta' efavirenz għandha terġa' tinbeda (ara sezzjonijiet 4.2 u 4.4).
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 Hikma)
Maltese: • Non-nucleoside reverse transcriptase inhibitors (eż. efavirenz, delavirdine, nevirapine)
English: Required Volumes of 10 mg/ml Voriconazole Hikma Concentrate
Maltese: Volumi Meħtieġa ta' 10 mg/ml ta' Konċentrat Voriconazole Hikma Volum ta' Konċentrat Voriconazole Hikma (10 mg/ml) meħtieġ għal:
English: Electrolyte disturbances such as hypokalemia, hypomagnesemia and hypocalcemia should be corrected prior to initiation of voriconazole therapy (see sections 4.2 and 4.4).
Maltese: Disturbi tal-elettroliti bħal ipokalimja, ipomanjesemija u ipokalċimja għandhom jiġu korretti qabel ma jinbeda t-trattament b'voriconazole (ara sezzjonijiet 4.2 u 4.4).
English: Liver dysfunction has usually been reversible on discontinuation of therapy (see section 4.8).
Maltese: Id-disturb tal-funzjoni tal-fwied ġeneralment kien riversibbli bittwaqqif tal-kura (ara sezzjoni 4.8).
English: The inter-individual variability of voriconazole pharmacokinetics is high.
Maltese: Il-varjabilità tal-farmakokinetika ta' voriconazole bejn individwi differenti hija għolja.
English: In vitro studies show that voriconazole may inhibit the metabolism of HIV protease inhibitors and the metabolism of voriconazole may also be inhibited by HIV protease
Maltese: jwaqqaf il-metaboliżmu tal-inibitur tal-protease ta' HIV u l-metaboliżmu ta' voriconazole jista' wkoll jiġi mwaqqaf minn inibituri tal-protease ta' HIV.
English: Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be monitored and corrected, if necessary, prior to initiation and during voriconazole therapy (see section 4.2).
Maltese: Disturbi elettroliti bħal ipokalimja, ipomanjesemija u ipokalċimja għandhom jiġu mmonitorjati u korretti, jekk ikun meħtieġ, qabel ma tinbeda u waqt terapija b'voriconazole (ara sezzjoni 4.2).
English: Do not take Voriconazole Hikma: - If you are allergic to the active ingredient voriconazole or to sulfobutylether beta cyclodextrin sodium
Maltese: X'għandek tkun taf qabel ma tieħu Voriconazole Hikma Tiħux b'Voriconazole Hikma: - jekk inti allerġiku għal sustanza attiva voriconazole, jew għal sulfobutylether beta cyclodextrin sodium (elenkati f'sezzjoni 6).
English: The effects on parturition are probably mediated by species-specific mechanisms, involving reduction of oestradiol levels, and are consistent with those observed with other azole antifungal agents.
Maltese: L-effetti fuq it-twelid probabbli huma medjati minn mekkaniżmi speċifiċi għall-ispeċi, li jinkludu t-tnaqqis tal-livelli ta' oestradiol, u huma konsistenti ma' dawk osservati b'aġenti antifungali oħra azoli.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 200 mg of voriconazole.
Maltese: Kull kunjett fih 200 mg ta' voriconazole.
English: Fifty-three paediatric patients aged 2 to <18 years were treated with voriconazole in two prospective, openlabel, non-comparative, multi-center clinical trials.
Maltese: 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: * Primary endpoint of study ** Using a margin of 5%, non inferiority is demonstrated ***Difference in proportions, 95% CI obtained after adjustment for randomization
Maltese: * Punt aħħari primarju tal-istudju ** Użu ta' marġni ta' 5%, tintwera li m'hemmx inferjorità *** Differenza fil-proporzjonijiet, 95% CI miksub wara aġġustament għall-għażla b'mod każwali Reġimi kondizzjonarji majeloablattivi
English: Short acting opiates (CYP3A4 substrate)
Maltese: Opiates li jaġixxu għal żmien qasir (sottostrat CYP3A4)
English: • Phenobarbital (used for severe insomnia and seizures)
Maltese: • Phenobarbital (użat għal nuqqas ta' rqad sever u attakki ta' puplesija)
English: It may only be continued up to 180 days after transplantation in case of continuing immunosuppression or graft versus host disease (GvHD) (see section
Maltese: Tista' titkompla biss għal 180 jum wara t-trapjant f'każ tat-tkomplija tal-immunosoppressjoni jew tal-graft versus host disease (GvHD) (ara sezzjoni 5.1).
English: Breakpoints
Maltese: Punti kruċjali
English: Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be monitored and corrected, if necessary, prior to initiation and during voriconazole therapy (see section 4.4).
Maltese: Disturbi elettroliti bħal ipokalimja, ipomanjesemija u ipokalċimja għandhom jiġu mmonitorjati u korretti, jekk ikun meħtieġ, qabel ma tinbeda u waqt terapija b'voriconazole (ara sezzjoni 4.4).
English: Efavirenz may be co-administered 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' jingħata flimkien ma' voriconazole jekk id-doża ta' manteniment ta' voriconazole tiżdied għal 400 mg kull 12-il siegħa u d-doża ta' efavirenz titnaqqas b'50 %, i.e. għal 300 mg darba kuljum.
English: After reconstitution with 19 ml of water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection, a clear solution is obtained.
Maltese: Wara r-rikostituzzjoni b'19 ml ta' ilma għal injezzjonijiet jew soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride għal injezzjoni, tinkiseb soluzzjoni ċara.
English: The absorption of voriconazole is not affected by changes in gastric pH.
Maltese: L-assorbiment ta' voriconazole mhux affettwat minn bidliet fil-pH gastriku.
English: • Existing symptomatic arrhythmias
Maltese: Arritmiji sintomatiċi eżistenti.
English: Each vial contains 200 mg voriconazole, equivalent to 10 mg/ml solution when reconstituted as directed by your hospital pharmacist or nurse.
Maltese: Kull kunjett fih 200 mg voriconazole, ekwivalenti għal soluzzjoni ta' 10 mg/ml meta rikostitwita kif indikat mill-ispiżjar jew infermier tal-isptar tiegħek.
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 sodium chloride 9 mg/ml (0.9%) solution for injection 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-injezzjoni.
English: How to store Voriconazole Hikma
Maltese: X'fih Voriconazole Hikma
English: • Alfentanil and fentanyl and other short acting opiates such as sufentanil (painkillers used for surgical procedures)
Maltese: • Alfentanil u fentanyl u opiates oħra li jaħdmu fuq qasir żmien bħal sulfentanil (mediċini kontra l-uġiegħ li jintużaw għal proċeduri kirurġiċi)
English: Prophylaxis in Adults and Children
Maltese: Profilassi fl-Adulti u t-Tfal
English: 10 Includes drug-induced liver injury, hepatitis toxic, hepatocellular injury and hepatotoxicity.
Maltese: Tinkludi korriment tal-fwied ikkaġunat mill-mediċina, epatite tossika, korriment epatoċellulari u tossiċità tal fwied.
English: The breakthrough IFI rate to Day 180 and the primary endpoint of the study, which is Success at Day 180, for patients with AML and myeloablative conditioning regimens respectively, is presented in the table below:
Maltese: Ir-rata ta' sfondament ta' IFIs sa Jum 180 u l-punt tat-tmiem primarju tal-istudju, li hu Suċċess f'Jum 180, għal pazjenti b'AML u reġimi kundizzjonarji majeloablattivi rispettivament, qed jiġu ppreżentata fit-tabella hawn taħt:
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Tagħrif iddettaljat dwar din il-mediċina huwa disponibbli fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
English: 8 mg/kg twice a day
Maltese: 8 mg/kg darbtejn kuljum 4 mg/kg darbtejn kuljum
English: • Exfoliative cutaneous reactions
Maltese: • Reazzjonijiet esfoljativi tal-ġilda
English: The frequency of phototoxicity reactions is higher in the paediatric population.
Maltese: Il-frekwenza ta' reazzjonijiet ta' fototossiċità hi ogħla fil-popolazzjoni fit-tfal.
English: • Flu-like symptoms, irritation and inflammation of the gastrointestinal tract, inflammation of the gastrointestinal tract causing antibiotic associated diarrhoea, inflammation of the lymphatic vessels
Maltese: • Infjammazzjoni tas-sistema gastrointestinali li tikkawża dijarea assoċjata mal-antibijotiċi, infjammazzjoni tal-vini limfatiċi
English: Co-administration 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 tal-ergotina (ergotamine, dihydroergotamine), li huma sottostrati ta' CYP3A4, billi konċentrazzjonijiet akbar ta' dawn il-prodotti mediċinali fil-plażma jistgħu jwasslu għal ergotiżmu (ara sezzjoni
English: • Oral contraceptives (if you take Voriconazole Hikma whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)
Maltese: • Kontraċettivi orali (jekk tieħu Voriconazole Hikma waqt li tkun qed tuża kontraċettivi orali,
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza(i) attiva(i) jew għal eċċipjenti mniżżla f'sezzjoni 6.1.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton 1 (or 5) vials including blue box
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kartuna ta' barra ta' kunjett 1 (jew 5) li tinkludi l-kaxxa blu
English: These visual impairmentswere transient and fully reversible, with the majority spontaneously resolving within 60 minutes and no clinically significant long-term visual effects were observed.
Maltese: Dawn l-indebolimenti viżwali ma damux u kompletament riversibbli, bil-maġġoranza jmorru b'mod spontanju fi żmien 60 minuta u ma kienu osservati ebda effetti viżwali klinikament sinifikanti fuq perjodu fit-tul.
English: Intravenous loading doses of 6 mg/kg IV twice daily on day 1 followed by 4 mg/kg intravenous dose twice daily and 300 mg oral tablets twice daily were evaluated in one adolescent pharmacokinetic study.
Maltese: Dożi inizjali fil-vina aktar qawwija ta' 6 mg/kg darbtejn kuljum fl-ewwel ġurnata segwiti minn doża fil-vina ta' 4 mg/kg darbtejn kuljum u pilloli li jittieħdu mil-ħalq ta' 300 mg kienu evalwati fi studju farmakokinetiku wieħed fl-adolexxenti.
English: Volume of Voriconazole Hikma Concentrate (10 mg/ml) required for:
Maltese: Volumi Meħtieġa ta' 10 mg/ml ta' Konċentrat ta' Voriconazole Hikma Volum ta' Konċentrat ta' Voriconazole Hikma (10 mg/ml) meħtieġ għal:
English: Voriconazole (N=248)
Maltese: Punt taż-żmien Voriconazole Amphotericin B → (N=248)
English: EUCAST Breakpoints
Maltese: Breakpoints tal-EUCAST Speċi ta' Candida
English: Conventional studies of safety pharmacology, genotoxicity or carcinogenic potential did not reveal a special hazard for humans.
Maltese: Studji konvenzjonali tal-farmakoloġija tas-sigurtà, ġenotossiċità jew potenzjal karċinoġeniku ma kixfux periklu speċjali għan-nies.
English: The pharmacokinetics of voriconazole are non-linear due to saturation of its metabolism.
Maltese: Il-farmakokinetika ta' voriconazole mhix lineari minħabba s-saturazzjoni tal-metaboliżmu tiegħu.
English: 4 mg/kg twice daily 200 mg twice daily
Maltese: 9 mg/kg kull 12-il siegħa
English: In the case of treatment-related adverse events, discontinuation of voriconazole and use of alternative antifungal agents must be considered (see section 4.4 and 4.8)
Maltese: Fil-każ ta' każijiet avversi assoċjati mattrattament, it-twaqqif ta' voriconazole u l-użu ta' mediċini antifungali alternattivi għandu jiġi kkunsidrat (ara sezzjoni 4.4 u 4.8).
English: There is no known antidote to voriconazole.
Maltese: M'hemmx antidotu magħruf għal voriconazole.
English: Success at day 100
Maltese: doża ta' 6
English: Increased ciclosporin levels have been associated with nephrotoxicity.
Maltese: Livelli ogħla ta' ciclosporin ġew assoċjati b'nefrotossiċità.