natgillin/translations-raw huggingface dataset:
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.
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.
Cardiovascular
Pożoloġija
Infuse at a maximum rate of 3 mg/kg per hour.
Erħi b'rata massima ta' 3mg/kg fis-siegħa.
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Huwa importanti li jiġu rrappurtati reazzjonijiet avversi ssuspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
Rare: may affect up to 1 in 1000 people
Rari: jistgħu jaffetwaw sa 1 kull 1,000 pazjent
In addition VFEND has been associated with phototoxicity including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria.
Barra minn hekk VFEND kien assoċjat ma' fototossiċità, li tinkludi reazzjonijiet bħal nemex, lentigo, keratożi aktinika u pseudoporphyria.
Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.
Profilassi ta' infezzjonijiet fungali invażivi f'riċevituri alloġeniċi f'riskju għoli ta' trapjant ta' ċelluli imsejħa stem fid-demm (HSCT).
Photosensitivity reactions such as ephelides, lentigo and actinic keratosis have been reported, especially during long-term therapy (see section 4.4).
Kienu rrapportati reazzjonijiet ta' fotosensittività bħal nemex, lentigo u keratożi aktinika, speċjalment waqt terapija fuq perjodu fit-tul (ara sezzjoni 4.4).
VFEND 50 mg film-coated tablets
VFEND 50 mg pilloli miksijin b'rita
Coadministration with sirolimus since voriconazole is likely to increase plasma concentrations of sirolimus significantly (see section 4.5).
L-amministrazzjoni flimkien ma' sirolimus billi voriconazole huwa probabbli li jżid ilkonċentrazzjonijiet fil-plasma ta' sirolimus b'mod sinifikanti (ara sezzjoni 4.5).
Rash
Sess
Solvent for VFEND powder for solution for infusion Sodium Chloride 0.9% in Water for Injections Intravenous use
Solvent għal VFEND trab għal soluzzjoni għall-infużjoni Sodium Chloride 0.9% fl-Ilma għall-Injezzjonijiet Użu ġol-vini
Dosage adjustment (Children [2 to <12 years] and young adolescents with low body weight [12 to 14 years and <50 kg])
Tfal (2 sa <12-il sena) u adoloxxenti żgħar li jiżnu inqas milli suppost (12 sa 14-il sena u <50 kg).
Renal and urinary disorders renal failure acute, haematuria renal tubular necrosis, proteinuria, nephritis
Disturbi filkliewi u fissistema urinarja insuffiċjenza talkliewi akuta, ematurja nekrosi tubulari talkliewi, proteinurja, nefrite
Infusion-related reactions
Reazzjonijiet relatati mal-infużjoni
VFEND 50 mg film-coated tablets voriconazole
VFEND 50 mg pilloli miksijin b'rita voriconazole
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.
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.
Infusion-related reactions, predominantly flushing and nausea, have been observed during administration of the intravenous formulation of voriconazole.
Reazzjonijiet relatati ma' l-infużjoni, predominantament fwawar u dardir, ġew osservati matul amministrazzjoni tal-formolazzjoni ġol-vini ta' voriconazole.
Each tablet contains 200 mg voriconazole.
Kull pillola fiha 200 mg ta' voriconazole.
• Cisapride (used for stomach problems)
• Cisapride (użat għal problemi ta' l-istonku)
Visual impairments
Indebolimenti viżwali
Currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.
Id-dejta disponibbli bħalissa hija deskritta f'sezzjoni 4.8 u 5.1, iżda ma tista' ssir l-ebda rakkomandazzjoni dwar il-pożoloġija.
200 mg (5 ml) every 12 hours
200 mg (5 ml) darbtejn kuljum
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.
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.
VFEND 200 mg film-coated tablets
VFEND 200 mg pilloli miksijin b'rita
Although not studied clinically, voriconazole is likely to increase the plasma concentrations of statins that are metabolised by CYP3A4 and could lead to rhabdomyolysis.
Għalkemm mhux studjat klinikament, voriconazole jista' jżid il-livelli tas-statins fil-plażma li huma metabolizzati minn CYP3A4 u jista' jwassal għal rhabdomyolysis.
1 sterile, single use vial adapter.
1 adapter tal-kunjett sterili, li jintuża darba biss.
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).
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).
Eye disorders visual impairment retinal haemorrhage optic nerve disorder papilloedema oculogyric crisis, diplopia, scleritis, blepharitis optic atrophy, corneal opacity
8, kriżi okuloġirika, tara doppju, sklerite, blefarite atrofija ottika, opaċità talkornea
• Oral contraceptives (if you take VFEND whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)
• Kontraċettivi orali (jekk tieħu VFEND waqt li tkun qed tuża kontraċettivi orali, jista' jkollok effetti mhux mixtieqa bħal dardir u disturbi mestrwali)
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).
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).
In a study in healthy volunteers investigating the impact of voriconazole on retinal function, voriconazole caused a decrease in the electroretinogram (ERG) waveform amplitude.
Fi studju fost voluntiera b'saħħithom li eżamina l-impatt ta' voriconazole fuq il-funzjoni tarretina, voriconazole kkawża tnaqqis fl-electroretinogram (ERG) waveform amplitude.
Hepatobiliary disorders liver function test abnormal jaundice, jaundice cholestatic, hepatitis hepatic failure, hepatomegaly, cholecystitis, cholelithiasis
Disturbi filfwied u filmarrara test tal-funzjoni tal-fwied b'riżultat anormali suffejra, suffejra kolestatika, epatite insuffiċjenza talfwied, epatomegalija, koleċistite, cholelithiasis
What VFEND contains -The active substance is voriconazole.
'fih VFEND - Is-sustanza attiva hi voriconazole.
Bottle
Kunjett
It is likely that these subjects may metabolize voriconazole more similarly to children than to adolescents/adults.
Probabilment dawn il-suġġetti jimmetabolizzaw voriconazole b'mod aktar simili tat-tfal milli dak tal-adolexxenti/adulti.
Median duration of IV voriconazole therapy was 10 days (range 2-85 days).
It-terapija b' voriconazole IV damet għal medja ta'għaxart ijiem (medda ta' 2-85 ġurnata).
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.
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.
Intravenous Children aged 2 to less than 12 years and teenagers aged 12 to 14 years weighing less than 50 kg
Tfal minn 2 sa anqas minn 12-il sena u teenagers ta' bejn 12 u 14-il sena li jiżnu anqas minn 50 kg
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.
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.
The pharmacokinetics of voriconazole are non-linear due to saturation of its metabolism.
Il-farmakokinetika ta' voriconazole mhix lineari minħabba s-saturazzjoni tal-metaboliżmu tiegħu.
Coadministration of voriconazole with everolimus is not recommended because voriconazole is expected to significantly increase everolimus concentrations (see section 4.4).
Amministrazzjoni ta' voriconazole flimkien ma' everolimus mhuwiex irrakkomandat għaliex voriconazole huwa mistenni li jżid sinifikament ilkonċentrazzjonijiet ta' everolimus (ara sezzjoni 4.4).
Patients 40 kg and above*
Orali Pazjenti li jiżnu 40 kg u aktar*
VFEND 200 mg film-coated tablets voriconazole
VFEND 200 mg pilloli miksijin b'rita voriconazole
The absorption of voriconazole is not affected by changes in gastric pH.
L-assorbiment ta' voriconazole mhux affettwat minn bidliet fil-pH gastriku.
- 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.
- 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.
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).
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).
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.
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.
• The required volume of the reconstituted concentrate is then added to a recommended compatible infusion solution listed below to obtain a final VFEND solution containing 0.5 to 5 mg/ml of voriconazole.
• Il-volum meħtieġ tal-konċentrat rikostitwit imbagħad jiġi miżjud ma' infużjoni kompatibbli rakkomandata għal infużjoni msemmija hawn isfel biex tinkiseb soluzzjoni finali ta' VFEND li jkun fiha 0.5 sa 5 mg/ml ta' voriconazole.
In vitro activity against the following pathogens has been shown, but the clinical significance is unknown: Curvularia spp.
Kienet murija attività in vitro kontra l-patoġeni li ġejjin, iżda l-importanza klinika mhix magħrufa: Curvularia spp. u Sporothrix spp.
Plasma protein binding is estimated to be 58%.
It-twaħħil mal-proteini tal-plasma huwa stmat għal 58%.
• Ritonavir (used for treating HIV) in doses of 400mg and more twice daily
• Ritonavir (użat għall-kura ta' l-HIV) f'dożi ta' 400 mg u aktar darbtejn kuljum
Excipient with known effect Each vial contains 217.6 mg sodium.
Eċċipjent bl-effett magħruf Kull kunjett fih 217.6 mg sodju.
For Caucasians and Blacks the prevalence of poor metabolisers is 3-5%.
Fil-każ tal-Kawkasi u s-Suwed il-prevalenza ta' metabolizzaturi ħżiena hija 3-5%.
Bioequivalence was established between the 200 mg tablet and the 40 mg/ml oral suspension when administered as a 200 mg dose.
Kienet stabbilita bijoekwivalenza bejn il-pillola ta' 200mg u s-suspensjoni orali ta' 40mg/ml meta mogħtija bħala doża ta' 200 mg.
5.1 Pharmacodynamic properties
5.1 Tagħrif farmakodinamiku
Musculoskelet al and connective tissue disorders back pain arthritis periostitis*
Disturbi muskoluskeletriċi u tat-tessuti konnettivi uġigħ tad-dahar artrite perjostite*
When multiple doses of voriconazole are administered with high fat meals, Cmax and AUCτ are reduced by 34% and 24%, respectively.
Meta dożi multipli ta' voriconazole jiġu mogħtija ma' ikliet b'kontenut għoli ta' xaħam, Cmax u AUC jitnaqqsu b'34% u 24%, rispettivament.
In the combined data from three bioequivalence studies using the powder for oral suspension formulation, treatment-related taste perversion was recorded in 12 (14%) of subjects.
Fid-dejta kkombinata minn tliet studji ta' bijoekwivalenza fejn intużat il-formulazzjoni tat-trab għal suspensjoni orali, kienet irreġistrata perverżjoni tat-togħma relatata mat-trattament fi 12 (14%) -il suġġett.
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:
Ir-rata ta' IFIs li jiġu f'daqqa sa Jum 180 u l-punt tat-tmiem primarju tal-istudju, li hu Suċċess f'Jum 180, għal pazjenti b'AML u reġim kondizzjunarju majeloablattiv rispettivament, qed tiġi ppreżentata fit-tabella hawn taħt:
200 mg (5 ml) twice a day
200 mg (5 ml) kull 12il siegħa
In rats, mice and dogs, voriconazole also induced minimal adrenal changes.
Fil-firien, ġrieden u klieb, voriconazole kkawża wkoll bidliet adrenali minimi.
Bottle outer pack and bottle label for 200 mg film-coated tablets - Pack of 2, 30, 100
Pakkett ta' barra tal-flixkun u t-tikketta tal-flixkun għal pilloli ta' 200 mg miksijin b'rita - Pakkett ta' 2,
• Phenobarbital (used for severe insomnia and seizures)
• Phenobarbital (użat għal nuqqas ta' rqad sever u attakki ta' puplesija)
Frequent monitoring for adverse reactions and toxicity related to methadone, including QTc prolongation, is recommended when coadministered with voriconazole since methadone levels increased following coadministration of voriconazole.
Huwa rrakkomandat monitoraġġ frekwenti għal reazzjoniiet 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 ma' voriconazole.
* Primary endpoint of study ** Using a margin of 5%, non inferiority is demonstrated *** Difference in proportions, 95% CI obtained after adjustment for randomization
* 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
No significant differences in Cmax and AUCτ were observed between healthy elderly females (≥ 65 years) and healthy young females (18-45 years).
Ma kinux osservati differenzi sinifikanti f'Cmax u AUC bejn nisa anzjani b'saħħithom ( 65 sena) u nisa żgħażagħ b'saħħithom (18-45 sena).
VFEND 200 mg powder for solution for infusion
VFEND 200 mg trab għal soluzzjoni għall-infużjoni
• VFEND powder for solution for infusion needs to first be 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 voriconazole.
• VFEND trab għal soluzzjoni għall-infużjoni l-ewwel irid jiġi rikostitwit bi 19-il ml Ilma għallInjezzjonijiet jew 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.
Conventional studies of safety pharmacology, genotoxicity or carcinogenic potential did not reveal a special hazard for humans.
Studji konvenzjonali tal-farmakoloġija tas-sigurtà, ġenotossiċità jew potenzjal karċinoġeniku ma kixfux periklu speċjali għan-nies.
Therapy must be initiated with the specified loading dose regimen of either intravenous or oral VFEND to achieve plasma concentrations on Day 1 that are close to steady state.
It-terapija trid tinbeda bl-iskema speċifikata tad-doża inizjali aktar qawwija ta' VFEND ġol-vini jew orali sabiex jinkisbu konċentrazzjonijiet tal-plasma fl-1 Jum li jkunu qrib ta' stat stabbli.
For administration, the required volume of the reconstituted concentrate is added to a recommended compatible infusion solution (detailed in the table below) to obtain a final voriconazole solution containing 0.5-5 mg/ml.
Biex jingħata, il-volum meħtieġ tal-konċentrat rikostitwit jiġi miżjud ma' soluzzjoni kompatibbli rakkomandata għall-infużjoni (dettaljata fit-tabella hawn isfel) biex tinkiseb soluzzjoni finali ta' voriconazole li fiha 0.5-5 mg/ml.
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.
Efavirenz jista' jingħata flimkien ma' voriconazole jekk id-doża ta' manteniment b'voriconazole tiżdied għal 400 mg kull 12-il siegħa u d-doża ta' efavirenz titnaqqas b'50 %, i.e. għal 300 mg darba kuljum.
Efavirenz 400 mg QD, coadministered with voriconazole 200 mg BID
Efavirenz 400 mg QD, amministrat flimkien ma' 200mg voriconazole BID
Liver dysfunction has usually been reversible on discontinuation of therapy (see section 4.8).
Id-disturb tal-funzjoni tal-fwied ġeneralment kien riversibbli bittwaqqif tal-kura (ara sezzjoni 4.8).
The modified intent-to-treat (MITT) group included 465 allogeneic HSCT recipients with 45% of patients having AML.
Ilgrupp modifikat b'intenzjoni ta' trattament (MITT) kien jinkludi 465 riċevitur alloġeniku ta' HSCT fejn 45% tal-pazjenti kellhom AML. Mill-pazjenti kollha, 58% kienu suġġetti għal skemi ta' kundizzjonijiet majeloablattivi.
• Patient Alert Card for Phototoxicity and SCC: - Reminds patients of the risk of phototoxicity and skin SCC.
• Kartuna ta' twissijja għal-Pazjent għal Fototossiċità u SCC:
Voriconazole (N=98)
Punti tat-tmiem tal-istudju Voriconazole (N=98)
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.
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-adoloxxenti.
An impurity present in SBECD has been shown to be an alkylating mutagenic agent with evidence for carcinogenicity in rodents.
Impurità, preżenti f'SBECD, intweriet li kienet aġent mutaġeniku alkalitiku b'evidenza għal karċinoġeniċità f'annimali gerriema.
VFEND 50 mg film-coated tablets and 200 mg film-coated tablets are available as packs of 2, 10, 14, 20, 28, 30, 50, 56 and 100.
Il-pilloli VFEND 50 mg miksijin b'rita u l-pilloli VFEND 200 mg miksijin b'rita huma disponibbli bħala pakketti ta' 2, 10, 14, 20, 28, 30, 50, 56 u 100.
• Remove the bag of VFEND solvent for solution for infusion from the foil overwrap (do not use scissors or any other sharp tool).
• Neħħi l-borża ta' VFEND solvent għal soluzzjoni għall-infużjoni mill-foil overwrap (tużax imqass jew xi ħaġa oħra li taqta').
VFEND 200 mg powder for solution for infusion: 30 ml clear Type I glass vial with rubber stopper and aluminium cap with plastic seal.
VFEND 200 mg trab u solvent għal soluzzjoni għall-infużjoni: VFEND trab u solvent għal soluzzjoni għall-infużjoni huwa disponibbli f'kaxxa li jkun fiha:
Fever
Fertilità
VFEND 200 mg powder and solvent for solution for infusion Voriconazole
VFEND 200 mg trab u solvent għal soluzzjoni għal infużjoni Voriconazole
including P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis and Trichosporon spp.
Disturbi filwidnejn u fissistema labirintika telf parzjali tassmigħ, sturdament, żanżin fil-widnejn
VFEND 200 mg powder and solvent for solution for infusion
VFEND 200 mg trab u solvent għal soluzzjoni għall-infużjoni
Bottle outer pack and bottle label for 50 mg film-coated tablets - Pack of 2, 30, 100
Pakkett ta' barra tal-flixkun u t-tikketta tal-flixkun għal pilloli ta' 50 mg miksijin b'rita - Pakkett ta' 2,
7a Attach the IV line to the patient injection site.
3a Neħħi l-qoxra tal-adattatur tal-kunjett u armiha.
Breast-feeding
Fil-vina
How to store VFEND
Kif gћandek tieћu VFEND
Inflammation of the sinuses, inflammation of the gums, chills, weakness Low numbers of some types, including severe, of red (sometimes immune-related) and/or white blood cells (sometimes with fever), low numbers of cells called platelets that help the blood to clot Low blood sugar, low blood potassium, low sodium in the blood Anxiety, depression, confusion, agitation, inability to sleep, hallucinations Seizures, tremors or uncontrolled muscle movements, tingling or abnormal skin sensations, increase in muscle tone, sleepiness, dizziness Bleeding in the eye
Infjammazjoni tas-sinus, infjammazzjoni tal-ħanek, kesħa, indeboliment - Ammonti baxxi ta' xi tipi, inkluż severi, ta' ċelloli tad-demm ħomor (xi kultant relatati malimmunità) u/jew bojod (xi kultant bid-deni), ammonti baxxi ta' ċelluli msejħa pjastrini li jgħinu lid-demm biex jagħqad - Livell baxx ta' zokkor fid-demm, livell baxx ta' potassium fid-demm, livell baxx ta' sodium fiddemm - Ansjetà, depressjoni, konfużjoni, aġitazzjoni, ma tkunx tista' torqod, alluċinazzjonijiet - Aċċessjonijiet, rogħda jew movimenti tal-muskoli mhux ikkontrollati, tnemnim jew sensazzjonijiet mhux normali tal-ġilda, żieda fit-ton tal-muskoli, ngħas, sturdament
Concomitant use of voriconazole and rifabutin should be avoided unless the benefit outweighs the risk (see section 4.5).
L-użu f'daqqa ta' voriconazole u rifabutin għandu jiġi evitat jekk il-benefiċċju ma jkunx akbar mir-riskju (ara sezzjoni 4.5).
Coadministration with high-dose ritonavir (400 mg and above twice daily) because ritonavir significantly decreases plasma voriconazole concentrations in healthy subjects at this dose (see section 4.5, for lower doses see section 4.4).
L-amministrazzjoni flimkien ma' doża għolja ta' ritonavir (400 mg u aktar darbtejn kuljum) billi ritonavir inaqqas b'mod sinifikanti l-konċentrazzjonijiet ta' voriconazole fil-plasma f'suġġetti b'saħħithom f'din id-doża (ara sezzjoni 4.5, għal dożi aktar baxxi ara sezzjoni 4.4).
Prophylaxis should be as short as possible depending on the risk for developing invasive fungal infection (IFI) as defined by neutropenia or immunosuppression.
Il-profilassi għandha tkun qasira kemm jista' jkun skont ir-riskju li titfaċċa infezzjoni fungali invażiva (IFI) kif definit minn newtropenija jew immunosoppressjoni.
Concomitant use of voriconazole and phenytoin should be avoided unless the benefit outweighs the risk (see section 4.5).
L-użu f'daqqa ta' voriconazole u phenytoin għandu jiġi evitat jekk il-benefiċċju ma jkunx akbar mir-riskju (ara sezzjoni 4.5).
The accumulation of 14 alpha-methyl sterols correlates with the subsequent loss of ergosterol in the fungal cell membrane and may be responsible for the antifungal activity of voriconazole.
L-akkumulazzjoni tal-14 alpha-methyl sterols jirrelata mat-telf sussegwenti ta' ergosterol fil-membrana taċ-ċellola fungali u jista' jkun responsabbli għal attività antifungali ta' voriconazole.
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).
Disturbi ta' lelettroliti 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).