natgillin/translations-raw huggingface dataset:
Following constitution, the volume of the suspension is 75 ml, providing a usable volume of 70 ml.
Wara li tiġi kostitwita, il-volum tas-suspensjoni jkun 75 ml, li jipprovdi volum użabbli ta' 70 ml.
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.
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.
IFI to day 100
Suċċess f'jum 100
VFEND is also available as 200 mg powder for solution for infusion, 200 mg powder and solvent for solution for infusion and 40 mg/ml powder for oral suspension.
VFEND huwa disponibbli wkoll bħala trab ta' 200 mg għal soluzzjoni għall-infużjoni, trab u solvent ta' 200 mg għal soluzzjoni għall-infużjoni u trab ta' 40 mg/ml għal suspensjoni orali.
• Oxycodone and other long-acting opiates such as hydrocodone (used for moderate to severe pain)
• Oxycodone u opiates oħra li jaħdmu fuq tul ta' żmien bħal hydrocodone (użati kontra l-uġigħ moderat u sever)
Blister foil for 50 mg film-coated tablets (all blister packs)
Fojl tal-folji għal 50 mg pilloli miksijin b'rita (il-pakketti tal-folji kollha)
Patients being treated with voriconazole are likely to be treated concomitantly with nephrotoxic medicinal products and have concurrent conditions that may result in decreased renal function (see section 4.8).
Il-pazjenti li jkunu qed jiġu kkurati b'voriconazole huma probabbli li jiġu kkurati fl-istess waqt bi prodotti mediċinali nefrotossiċi u jkollhom kondizzjonijiet konkorrenti li jistgħu jwasslu għal funzjoni mnaqqsa tal-kliewi (ara sezzjoni 4.8).
1 single use 30 ml clear Type I glass vial with rubber stopper and aluminium cap with plastic seal of VFEND 200 mg, powder for solution.
1 kunjett tal-ħġieġ ċar ta' 30 ml, ta' Tip I, li jintuża darba biss, b'tapp tal-lastku u għatu tal-aluminju b'siġill tal-plastik ta' VFEND 200 mg, trab għal soluzzjoni.
VFEND 50 mg film-coated tablets VFEND 200 mg film-coated tablets Voriconazole
VFEND 50 mg pilloli miksijin b'rita VFEND 200 mg pilloli miksijin b'rita Voriconazole
Pharmacokinetics in special patient groups
Farmakokinetika fi gruppi ta' pazjenti speċjali
8 mg/kg twice daily
8 mg/kg darbtejn kuljum
• 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.
• Checklist tal-Professjonist fil-Qasam Mediku (HCP) għal Fototossiċità, SCC u Tossiċità talFwied
The predicted total exposures in children following IV maintenance doses of 4 and 8 mg/kg twice daily were comparable to those in adults following 3 and 4 mg/kg IV twice daily, respectively.
Lesponimenti totali mbassra fit-tfal wara dożi ta' manteniment fil-vina ta' 4 u 8 mg/kg darbtejn kuljum kienu kumparabbli ma' dawk tal-adulti wara dożi fil-vina ta' 3 u 4 mg/kg darbtejn kuljum, rispettivament.
VFEND must not be diluted with 4.2% Sodium Bicarbonate Infusion.
VFEND m'għandux jiġi dilwit b'4.2% Infużjoni ta' Bikarbonat tas-Sodju.
The recommended doses in children and adolescent patients are based on a population pharmacokinetic analysis of data obtained from 112 immunocompromised paediatric patients aged 2 to <12 years and 26 immunocompromised adolescent patients aged 12 to <17 years.
Id-dożi rrakkomandati fil-pazjenti tfal u adoloxxenti huma bbażati fuq analiżi farmakokinetika talpopolazzjoni ta' dejta miksuba minn 112 pazjenti immunokompromessi tfal fl-etajiet ta' 2 sa <12-il sena u 26 pazjenti adoloxxenti immunokompromessi fl-etajiet ta' 12 sa <17-il sena.
Depending on the severity of symptoms, consideration should be given to stopping treatment (see section 4.8).
Jiddependi fuq is-severità tas-sintomi, għandha tingħata kunsiderazzjoni għat-twaqqif tat-trattament (ara sezzjoni 4.8).
Vial contains 200 mg of voriconazole.
Kunjett fih 200 mg ta' voriconazole.
A relationship between plasma concentrations and age was observed.
Kienet osservata relazzjoni bejn il-konċentrazzjonijiet fil-plasma u l-età.
300 mg QD (coadministered with voriconazole 400 mg BID)
300 mg QD (amministrat flimkien ma' voriconazole 400 mg BID)
4 mg/kg twice daily 200 mg twice daily 100 mg twice daily
4 mg/kg darbtejn kuljum200 mg darbtejn kuljum 100 mg darbtejn kuljum
BATCH NUMBER
NUMRU TAL-LOTT
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 inhibitors.
Studji in vitro wrew li voriconazole jista' jwaqqaf il-metaboliżmu tal-inibituri tal-protease tal-HIV u lmetaboliżmu ta' voriconazole jista' wkoll jiġi mwaqqaf mill-inibituri tal-protease tal-HIV.
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.
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.
100 mg (2.5 ml) twice daily
100 mg (2.5 ml) darbtejn kuljum
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.
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.
PHARMACEUTICAL PARTICULARS
GĦAMLA FARMAĊEWTIKA
Coadministration with St. John's Wort (see section 4.5).
John's wort (fexfiex) (ara sezzjoni 4.5).
400 mg (10 ml) every 12 200 mg (5 ml) every 12
400 mg (10 ml) kull 12il siegħa
• Ritonavir (used for treating HIV) in doses of 100 mg twice daily
• Ritonavir (użat għall-kura ta' l-HIV) f'dożi ta' 100 mg u aktar darbtejn kuljum
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).
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).
• Omeprazole (used for treating ulcers)
• Omeprazole (użat għall-kura ta' l-ulċeri)
Includes drug-induced liver injury, hepatitis toxic, hepatocellular injury and hepatotoxicity.
Tinkludi korriment tal-fwied ikkaġunat mill-mediċina, epatite tossika, korriment epatoċellulari u tossiċità talfwied.
• you are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome'.
• 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'.
Other side effects
Effetti sekondarji oħra
• Sinus bradycardia.
Siringa waħda
Nine subjects in the voriconazole group and 5 in the amphotericin B followed by fluconazole group also had mycologically proven infection in deep tissue.
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.
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).
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).
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.
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.
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
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)
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Sensittività eċċessiva għas-sustanza attiva jew għal xi eċċipjenti mniżżla f'sezzjoni 6.1.
Monitoring for voriconazole-associated adverse reactions is recommended if voriconazole is used sequentially after fluconazole.
Monitoraġġ għal avvenimenti avversi assoċjati ma' voriconazole huwa rrakkomandat jekk voriconazole se jintuża wara fluconazole.
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).
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).
4 mg/kg dose (number of vials)
doża ta' 4 mg/kg (numru ta' kunjetti)
In clinical trials there were 3 cases of accidental overdose.
F'testijiet kliniċi kien hemm 3 każijiet ta' doża eċċessiva aċċidentali.
Frequent monitoring for adverse reactions and toxicity related to NSAIDs is recommended.
Monitoraġġ frekwenti għal episodji avversi u tossiċità relatati ma' NSAIDs, huwa rrakkomandat.
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.
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%.
Oral suspension Patients 40 kg and above Patients less than 40 kg
Suspensjoni orali Pazjenti li jiżnu 40 kg u aktar
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.
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.
9 mg/kg dose (number of vials)
doża ta' 9 mg/kg (numru ta' kunjetti)
Teenagers aged 12 to 14 years weighing 50 kg or more; and all teenagers older than 14
Teenagers ta' bejn 12 u 14-il sena li jiżnu 50 kg jew aktar; u t-teenagers kollha ta' aktar minn 14il sena
Non-infectious periostitis with elevated fluoride and alkaline phosphatase levels has been reported in transplant patients.
Kien hemm rapporti ta' perjostite (periostitis) mhux infettiva b'livelli ta' fluoride u alkaline phosphate għoljin f'pazjenti tat-trapjanti.
Not for bolus injection
Mhux għal injezzjoni bolus
Risk Management Plan (RMP)
• Pjan tal-ġestjoni tar-riskju (RMP)
Rifabutin [potent CYP450 inducer]
Rifabutin (induttur qawwi ta' CYP450)
Side effects with frequency not known: Freckles and pigmented spots
Effetti sekondarji bi frekwenza mhux magħrufa: - Nemex u tikek pigmentati
Interaction Geometric mean changes (%)
Bdil fil-medja ġeometrika talinterazzjoni (%)
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.
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.
VFEND 200 mg powder and solvent for solution for infusion Powder for solution for infusion: White lyophilised powder.
VFEND 200 mg trab u solvent għal soluzzjoni għall-infużjoni Trab għal soluzzjoni għall-infużjoni: Trab abjad ixxottat bil-friża.
All other adolescents (12 to 14 years and ≥50 kg; 15 to 17 years regardless of body weight) Voriconazole should be dosed as adults.
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.
Excipient with known effect Each bag contains 177.02 mg sodium.
Eċċipjent bl-effett magħruf Kull borża fiha 177.02 mg sodju.
VFEND 200 mg powder for solution for infusion:
VFEND 200 mg trab għal soluzzjoni għall-infużjoni:
The studies included cerebral, sinus, pulmonary and disseminated aspergillosis in patients with bone marrow and solid organ transplants, haematological malignancies, cancer and AIDS.
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.
• Pimozide (used for treating mental illness)
• Pimozide (użat għall-kura ta' mard mentali)
A higher frequency of liver enzyme elevations was observed in the paediatric population (see section 4.8).
Ġiet osservata frekwenza ogħla ta' żidiet ta' enzimi fil-fwied fil-popolazzjoni pedjatrika (ara sezzjoni 4.8).
Each tablet contains 50 mg voriconazole.
Kull pillola fiha 50 mg ta' voriconazole.
Each tablet contains 50 or 200 mg voriconazole.
Kull pillola fiha 50 jew 200 mg ta' voriconazole.
EXP Shelf life after reconstitution: 24 hours when stored at 2°C - 8°C.
Żmien kemm idum tajjeb il-prodott wara rikostituzzjoni: 24 siegħa meta maħżun f'temperatura ta' 2C - 8C.
18.UNIQUE IDENTIFIER - HUMAN READABLE DATA
IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
Reconstituted VFEND concentrate needs to be further diluted with sodium chloride (0.9%) infusion solution within the infusion bag before it is infused.
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.
ANNEX II
ANNESS II
VFEND 200 mg powder and solvent for solution for infusion:
VFEND 200 mg trab u solvent għal soluzzjoni għall-infużjoni:
VFEND, is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:
VFEND, huwa aġent antifungali triazole bi spettru wiesa' li huwa indikat fl-adulti u fit-tfal ta' sentejn jew aktar kif ġej:
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.
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.
Hair loss
Bijotrasformazzjoni
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.
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.
Each bottle contains 45 g of powder providing 70 ml of suspension when constituted with water as recommended.
Kull flixkun fih 45 g trab li jipprovdu 70 ml ta' suspensjoni meta jiġu kostitwiti bl-ilma kif rakkomandat.
Voriconazole is rapidly and almost completely absorbed following oral administration, with maximum plasma concentrations (Cmax) achieved 1-2 hours after dosing.
Voriconazole huwa assorbit malajr u kważi kompletament wara amministrazzjoni orali, b'konċentrazzjonijiet massimi fil-plasma (Cmax) jinkisbu siegħa sa sagħtejn wara d-doża.
: 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.
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.
• candidaemia (another type of fungal infection due to Candida sp) in non-neutropenic patients (patients without abnormally low white blood cells count),
• 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),
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).
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).
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).
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).
8, drug reaction with eosinophilia and systemic symptoms (DRESS) angioedema, actinic keratosis*, pseudoporphyria , erythema multiforme, psoriasis, drug eruption cutaneous lupus erythemato sus*, ephelides*, lentigo*
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*
Reporting of suspected adverse reactions
Rappurtar ta' reazzjonijiet avversi suspettati
6 mg/kg dose (number of vials)
doża ta' 6 mg/kg (numru ta' kunjetti)
Infections and infestations sinusitis pseudomembranous colitis
Infezzjonijiet u infestazzjoniji et sinusite kolite psewdomembranuż
Itchiness
Anzjani
Four additional patients with fusariosis had an infection caused by several organisms; 2 of them had a successful outcome.
Erba' pazjenti oħra b'fusariosis kellhom infezzjoni kkawżata minn diversi organiżmi; 2 minnhom kellhom eżitu ta' suċċess.
The inter-individual variability of voriconazole pharmacokinetics is high.
Il-varjabilità tal-farmakokinetika ta' voriconazole bejn individwi differenti hija għolja.
Voriconazole N=224
Punti tat-Tmiem tal-Istudju Voriconazole N=224
In clinical studies, response to voriconazole in C. krusei infections was similar to C. albicans, C. parapsilosis and C. tropicalis.
Fi studji kliniċi, ir-rispons għal voriconazole f'infezzjonijiet ta' C. krusei kien simili għal dak ta' C. albicans, C. parapsilosis u C. tropicalis.
After reconstitution each ml contains 10 mg of voriconazole.
Wara rikostituzzjoni, kull ml fih 10 mg ta' voriconazole.
VFEND 200 mg powder for solution for infusion voriconazole
VFEND 200 mg trab għal soluzzjoni għal infużjoni Voriconazole
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).
Kull pillola fiha 50 mg (għal VFEND 50mg pilloli miksija b'rita) jew 200mg (għal VFEND 200mg pilloli miksija b'rita) ta' voriconazole.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
Dwar il-kondizzjonijiet għall-ħażna tal-prodott mediċinali wara r-rikostituzzjoni, ara sezzjoni 6.3.
Label on the vial
Kartuna ta' barra
Fifty-three paediatric patients aged 2 to <18 years were treated with voriconazole in two prospective, openlabel, non-comparative, multi-center clinical trials.
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.
• 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.
• 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.
• Exfoliative cutaneous reactions
• Reazzjonijiet esfoljativi tal-ġilda
• 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.
• 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.
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
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.
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.
The safety profile and plasma concentrations observed in male and female patients were similar.
Il-profil tas-sigurtà u lkonċentrazzjonijiet fil-plasma osservati f'pazjenti rġiel u nisa kienu simili.
There is no known antidote to voriconazole.
M'hemmx antidotu magħruf għal voriconazole.
VFEND 200 mg powder for solution for infusion Each vial contains 200 mg of voriconazole.
VFEND 200 mg trab għal soluzzjoni għall-infużjoni Kull kunjett fih 200 mg ta' voriconazole.
Duration of treatment
Trattament fit-tul
No clinically significant differences were seen when the safety data were analysed by age, race, or gender.
Ebda differenzi klinikament sinifikanti ma kienu jidhru meta d-dejta tas-sigurtà ġiet analizzata skont l-età, razza jew sess.
• 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.
• 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.