FrancophonIA/ELRC3.0 huggingface dataset:
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 - Inflammation of the thin tissue that lines the inner wall of the abdomen and covers the abdominal organ - Enlarged lymph glands (sometimes painful), failure of blood marrow, increased eosinophil - Depressed function of the adrenal gland, underactive thyroid gland - Abnormal brain function, Parkinson-like symptoms, nerve injury resulting in numbness, pain,
Maltese: - Sintomi qishom tal-influwenza, irritazzjoni u infjamazzjoni tal-passaġġ gastrointestinali, infjammazzjoni tas-sistema gastrointestinali li tikkawża dijarea assoċjata mal-antibijotiċi, infjammazzjoni tal-vini limfatiċi - Infjammazzjoni tat-tessut irqiq li jiksi l-ħajt intern taż-żaqq u jiksi l-organi addominali - Tkabbir tal-glandola limfatika (xi kultant bl-uġigħ), insuffiċjenza tal-mudullun, żieda fleosinofili - Funzjoni depressa tal-glandola adrenali, glandola tat-tirojde mhux attiva biżżejjed - Funzjoni mhux normali tal-moħħ, sintomi qishom tal-marda ta' Parkinson, ferita fin-nervaturi li tirriżulta fi tmewwit, uġigħ, tnemnim jew ħruq fl-idejn jew fis-saqajn - Problemi bil-bilanċ jew koordinazzjoni - Nefħa tal-moħħ - Tara doppju, kundizzjonijiet serji tal-għajnejn li jinkludu: uġigħ u infjammazzjoni ta' l-għajnejn u tal-kpiepel ta' l-għajnejn, moviment mhux normali tal-għajnejn, ħsara lin-nervaturi talgħajnejn li tirriżulta f'indeboliment tal-vista, nefħa fid-disk tal-għajnejnSensittività mnaqqsa għall-mess - Sens anormali tat-togħma - Diffikultajiet fis-smigħ, tisfir fil-widnejn, sturdament
English: Film-coating
Maltese: Fil-vini
English: (a maximum dose of 350 mg twice daily) Note: Based on a population pharmacokinetic analysis in 112 immunocompromised paediatricpatients aged 2 to <12 years and 26 immunocompromised adolescents aged 12 to <17 years.
Maltese: Nota: Fuq bażi tal-analiżi farmakokinetika tal-popolazzjoni fi 112 pazjenti immunokompromessi tfal ta' bejn 2 u <12-il sena u 26 adoloxxenti immunokompromessi ta' bejn 12 u <17-il sena.
English: What Voriconazole Accord looks like and contents of the pack Voriconazole Accord 50 mg film-coated tablets are supplied as white to off white, round, approximate 7.0mm in diameter, film-coated tablets, debossed with ‘V50' on one side and plain on the other side.
Maltese: Kif jidher Voriconazole Accord u l-kontenut tal-pakkett Voriconazole Accord 50 mg pilloli miksija b'rita huma fornuti bħala pilloli tondi ta' kulur abjad għal offwajt miksijin b'rita, b'dijametru ta' 7.0mm, b'‘V50' imnaqqax fuq naħa u n-naħal-oħra lixxa.
English: Monitoring of pancreatic function
Maltese: Monitoraġġ tal-funzjoni tal-pankreas
English: Monitoring for voriconazoleassociated 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: Efavirenz 300 mg QD, coadministered with voriconazole 400 mg BID*
Maltese: Efavirenz 300 mg QD, amministrazzjoni flimkien ma' voriconazole 400 mg BID*
English: Voriconazole Accord 200 mg film-coated tablets
Maltese: Voriconazole Accord 200 mg pilloli miksijin b'rita
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 inhibitors.
Maltese: Studji in vitro wrew li voriconazole jista' jwaqqaf il-metaboliżmu tal-inibituri tal-protease tal-HIV u l-metaboliżmu ta' voriconazole jista' wkoll jitwaqqaf mill-inibituri tal-protease tal-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, hypomagnesaemia u ipokalċimja għandhom jiġu mmonitorjati u korretti, jekk ikun meħtieġ, qabel ma tinbeda u waqt terapija b'voriconazole (ara sezzjoni 4.2).
English: [CYP450 inducer; CYP3A4 inhibitor and substrate]
Maltese: CYP450; inibitur u substrat ta' CYP3A4]
English: 300 mg QD (coadministered with voriconazole 400 mg BID)*
Maltese: 300 mg QD (amministrazzjoni flimkien ma' voriconazole 400 mg BID)*
English: Phenytoin may be co-administered 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).
Maltese: 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
English: Hepatobiliary disorders liver function test abnormal jaundice, jaundice cholestatic, hepatitis10
Maltese: Disturbi filfwied u filmarrara test talfunzjoni talfwied mhux normali suffejra, suffejra kolestatika, epatite10
English: Each tablet contains either 50 mg voriconazole (for Voriconazole Accord 50 mg film-coated tablets) or 200 mg voriconazole (for VoriconazoleAccord 200 mg film-coated tablets).
Maltese: Kull pillola fiha jew 50 mg (għal Voriconazole Accord 50 mg pilloli miksija b'rita) jew 200 mg (għal Voriconazole Accord 200 mg pilloli miksija b'rita) ta' voriconazole.
English: Of these 7 patients, 3 had eye, 1 had sinus, and 3 had disseminated infection.
Maltese: Minn dawn is-7 pazjenti, 3 kellhom infezzjoni f'għajnejhom, 1 kellu infezzjoni tas-sinus, u 3 kellhom infezzjoni mifruxa.
English: The safety of voriconazole was also investigated in 158 additional paediatric patients aged 2 to <12 years in compassionate use programs.
Maltese: Is-sigurtà ta' voriconazole ġiet investigata wkoll f'158 pazjent pedjatriku ieħor li għandhom bejn sentejn u <12-il sena f'programmi ta' użu b'kompassjoni.
English: [CYP3A4 substrates]
Maltese: [substrati ta' CYP3A4]
English: Coadministration of voriconazole and low dose ritonavir (100 mg BID) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole.
Maltese: Amministrazzjoni ta' voriconazole flimkien ma' doża baxxa ta' ritonavir (100 mg BID) għandha tiġi evitata, sakemm ma jkunx hemm evalwazzjoni talbenefiċċju/riskju għallpazjent li tiġġustifika l-użu ta' voriconazole.
English: Voriconazole Accord 200 mg film-coated tablets voriconazole
Maltese: Voriconazole Accord 200 mg pilloli miksijin b'rita Voriconazole
English: Voriconazole Accord 50 mg film-coated tablets Voriconazole Accord 200 mg film-coated tablets voriconazole
Maltese: Voriconazole Accord 50 mg pilloli miksijin b'rita Voriconazole Accord 200 mg pilloli miksijin b'rita Voriconazole
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, hypomagnesaemia u ipokalċimja għandhom jiġu mmonitorjati u korretti, jekk ikun meħtieġ, qabel ma tinbeda u waqt terapija b'voriconazole (ara sezzjoni 4.4).
English: Voriconazole Accord 50 mg film-coated tablets voriconazole
Maltese: Voriconazole Accord 50 mg pilloli miksijin b'rita Voriconazole
English: Voriconazole Accord 50 mg film-coated tablets
Maltese: Voriconazole Accord 50 mg pilloli miksijin b'rita
English: Patients less than 40 kg*
Maltese: Pilloli Pazjenti li jiżnu 40 kg u aktar
English: Women of child-bearing potential
Maltese: Reġim kondizzjunarju majeloablattiv
English: System
Maltese: LISTA
English: Phenytoin may be coadministered with voriconazole if the maintenance dose of voriconazole is increased from 200 mg to 400 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: Phenytoin jista' jingħata flimkien ma' voriconazole jekk id-doża ta' manteniment ta' voriconazole tiżdied minn 200 mg għal 400 mg b'mod orali, darbtejn kuljum; u fil-każ ta' pazjenti li jiżnu anqas minn 40 kg id-doża ta' manteniment tiżdied minn 100 mg għal 200 mg b'mod orali, darbtejn kuljum, ara sezzjonijiet 4.4 u 4.5.
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 tal-istatins fil-plażma li huma metabolizzati minn CYP3A4 u jista' jwassal għal rhabdomyolysis.
English: Efavirenz 400 mg QD, coadministered with voriconazole 200 mg BID*
Maltese: Efavirenz 400 mg QD, amministrat flimkien ma' 200 mg voriconazole BID*
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: • Professjonist fil-Qasam Mediku (HCP): Fuljett b'Mistoqsijiet u Tweġibiet dwar ilFototossiċità, SCC u Tossiċità tal-Fwied;
English: • you are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome'.
Maltese: • jekk huwa magħruf li għandek kardjomijopatija, taħbit irregolari tal-qalb, taħbit tal-qalb bil-mod jew anormalità ta' l-elettrokardjogramma (ECG) imsejħa ‘sindrome tal-QTc twil'.
English: squamous cell carcinoma
Maltese: karċinoma fiċ-ċelluli skwamużi
English: 300 mg QD (co-administered with voriconazole 400 mg BID)*
Maltese: 300 mg QD (amministrat flimkien ma' voriconazole 400 mgBID)*
English: White to off white, oval, approximately 15.6 mm in length and 7.8 mm in width, film-coated tablets, debossed with ‘V200' on one side and plain on the other side.
Maltese: Pillola ta' kulur abjad għal offwajt, b'tul ta' madwar 15.6 mm u b'wisa' ta' madwar 7.8 mm, miksija b'rita, b'“V200” imnaqqax fuq naħa u n-naħa l-oħra lixxa.
English: Frequent monitoring for adverse reactions and toxicity related to methadone, including QTc prolongation, is recommended.
Maltese: Huwa rakkomandat monitoraġġ frekwenti għal episodji avversi u tossiċità relatati ma' methadone, fosthom titwil tal-QTc.
English: optic disc swelling - Decreased sensitivity to touch - Abnormal sense of taste - Hearing difficulties, ringing in the ears, vertigo - Inflammation of certain internal organs- pancreas and duodenum, swelling and inflammation of the tongue - Enlarged liver, liver failure, gallbladder disease, gallstones - Joint inflammation, inflammation of the veins under the skin (which may be associated with the formation of a blood clot) - Inflammation of the kidney, proteins in the urine, damage to the kidney - Very fast heart rate or skipped heartbeats, sometimes with erratic electrical impulses - Abnormal electrocardiogram (ECG) - Blood cholesterol increased, blood urea increased - Allergic skin reactions (sometimes severe), including life-threatening skin condition that causes painful blisters and sores of the skin and mucous membranes, especially in the mouth,
Maltese: - Infjammazzjoni ta' ċerti organi interni - il-frixa u d-duwodenu, nefħa u infjammazzjoni talilsien - Fwied akbar, insuffiċjenza tal-fwied, mard tal-bużżieqa tal-marrara, ġebel fil-marrara - Infjammazzjoni fil-ġogi, infjammazzjoni tal-vini taħt il-ġilda (li tista' tiġi assoċjata malformazzjoni ta' embolu tad-demm) - Infjammazzjoni tal-kliewi, proteini fl-awrina, ħsara fil-kliewi - Rata mgħaġġla ħafna ta' taħbit tal-qalb jew il-qalb titlef xi taħbit, xi kultant b'impulsi elettriċi erratiċi - Elettrokardjogramm (ECG) anormali - Żieda fil-livell ta' kolesterol fid-demm, żieda fil-livell ta' urea fid-demm - Reazzjonijiet allerġiċi tal-ġilda (xi kultant severi), li jinkludu kundizzjoni tal-ġilda ta' periklu għall-ħajja li tikkawża bżieżaq u selħiet bl-uġigħ fil-ġilda u fil-membrani mukużi, speċjalment fil-ħalq urtikarja, ħruq mix-xemx jew reazzjoni severa tal-ġilda wara esponiment għad-dawl jew għax-xemx, ħmura u irritazzjoni tal-ġilda, tibdil fil-kulur aħmar jew vjola tal-ġilda li jista' jiġi kkawżat minn għadd baxx ta' pjastrini, ekżema - Reazzjoni fis-sit tal-infużjoni Reazzjoni allerġika jew rispons immunitarju esaġerat
English: 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.
Maltese: Huwa rrakkomandat monitoraġġ frekwenti għal reazzjonijiet avversi u tossiċità relatata malmethadone, inkluż titwil tal-QTc, meta l-methadone jingħata ma' voriconazole billi l-livelli talmethadone żdiedu wara li ngħata ma' voriconazole.
English: NAME OF THE MEDICINAL PRODUCT Voriconazole Accord 50 mg film-coated tablets Voriconazole Accord 200 mg film-coated tablets
Maltese: Voriconazole Accord 50 mg pilloli miksijin b'rita Voriconazole Accord 200 mg pilloli miksijin b'rita
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 bit-twaqqif tal-kura (ara sezzjoni 4.8).
English: • Ritonavir (used for treating HIV) in doses of 400 mg and more twice daily
Maltese: • Ritonavir (użat għall-kura ta' l-HIV) f'dożi ta' 400 mg u aktar darbtejn kuljum
English: [CYP3A4 substrate]
Maltese: [substrat ta' CYP3A4]
English: Voriconazole Accord 200 mg film-coated tablets Each tablet contains 200 mg voriconazole.
Maltese: Voriconazole Accord 200 mg pilloli miksijin b'rita Kull pillola fiha 200 mg ta' voriconazole.
English: 4 Includes hypoxic-ischaemic encephalopathy and metabolic encephalopathy.
Maltese: Tinkludi enċefalopatija iskemika-ipoksika u enċefalopatija metabolika.
English: [potent CYP450 inducers]
Maltese: [indutturi qawwijin ta' CYP450]
English: [CYP3A4 inhibitor]
Maltese: [inibitur ta' CYP3A4]
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 tar-retina, voriconazole kkawża tnaqqis fl-electroretinogram (ERG) waveform amplitude.
English: • Sinus bradycardia.
Maltese: • Żomm dan il-fuljett.
English: 200 mg twice daily
Maltese: 200 mg kull 12-il siegħa
English: [non-specific CYP450 inhibitor and increases gastric pH]
Maltese: [inibitur mhux speċifiku ta' CYP450 u jżid il-pH flistonku]
English: 4 mg/kg twice daily
Maltese: 6 mg/kg kull 12-il siegħa
English: Skin and subcutaneous tissue disorders rash dermatitis exfoliative, alopecia, rash maculo-papular, pruritus, erythema
Maltese: Disturbi filġilda u fittessuti ta' taħt il-ġilda raxx dermatite sfoljattiva, ħakk, raxx makulari blinfafet, alopeċja, eritema
English: White to off white, round, approximate 7.0 mm in diameter, film-coated tablets, debossed with ‘V50' on one side and plain on the other side.
Maltese: Pillola ta' kulur abjad għal offwajt, b'dijametru ta' madwar 7.0 mm , miksija b'rita, b' “V50” imnaqqax fuq naħa u n-naħal-oħra lixxa.
English: AUCτ, AUCt and AUC0-∞represent area under the curve over a dosing interval, from time zero to the time with detectable measurement and from time zero to infinity, respectively.
Maltese: L-AUCτ,, AUCt u AUC0-∞jirrapreżentaw l-arja ta' taħt il-kurva għal interval ta' dożaġġ, minn ħin zero sal-aħħar kejl kwantifikabbli u minn ħin zero sal-infinità, rispettivament.
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 din il-kombinazzjoni hija strettament meħtieġa, id-doża ta' manteniment ta' voriconazole tista' tiżdied minn 200 mg għal 350 mg b'mod orali, darbtejn kuljum; u fil-każ ta' pazjenti li jiżnu anqas minn 40 kg id-doża ta' manteniment tiżdied minn 100 mg għal 200 mg b'mod orali, darbtejn kuljum, ara sezzjonijiet 4.4 u 4.5.
English: Visual impairments
Maltese: Indebolimenti viżiv
English: Prophylaxis in adults and children
Maltese: Profilassi fl-adulti u t-tfal
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 mhijiex irrakkomandata għaliex voriconazole huwa mistenni li jżid b'mod sinifikanti ilkonċentrazzjonijiet ta' everolimus (ara sezzjoni 4.4).
English: Mycophenolic acid (1 g single dose)
Maltese: Aċidu mikofenoliku (doża waħda ta' 1 g) [substrat ta'
English: 300 mg TID (coadministered with voriconazole 400 mg single dose)
Maltese: 300 mg TID (mogħti flimkien ma' doża waħda ta' 400 mg voriconazole)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Voriconazole Accord 50 mg film-coated tablets Each tablet contains 50 mg voriconazole.
Maltese: Voriconazole Accord 50 mg pilloli miksijin b'rita Kull pillola fiha 50 mg ta' voriconazole.
English: Voriconazole Accord 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 Voriconazole Accord fihom il-lattosju u m'għandhomx jingħataw lil pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew assorbiment ħażin talglukosju-galactose.
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) mbassar fittfal 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. 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.
English: Careful monitoring of full blood counts and adverse reactions to rifabutin (e.g., uveitis) is recommended when rifabutin is coadministered with voriconazole.
Maltese: Huwa rrakomandatmonitoraġġ ta' episodji avversi relatati ma' kontraċettivi orali, kif ukoll dawk relatati ma' voriconazole.
English: When voriconazole treatment is stopped, the initial dose of efavirenz should be restored (see section 4.2 and 4.4).
Maltese: Meta ittrattament b'voriconazole jitwaqqaf, id-doża tal-bidu ta' efavirenz għandha terġa' tinbeda (ara sezzjoni 4.2 u 4.4).
English: Voriconazole was administered intravenously with a loading dose of 6 mg/kg every 12 hours for the first 24 hours followed by a maintenance dose of 4 mg/kg every 12 hours for a minimum of 7 days.
Maltese: Voriconazole ingħata ġol vina b'doża inizjali ta' 6 mg/kg kull 12 -il siegħa għall-ewwel 24 siegħa segwita minn doża ta' manteniment ta' 4 mg/kg kull 12 -il siegħa għal tal-anqas 7 ijiem.
English: Voriconazole Accord should be discontinued if premalignant skin lesions or squamous cell carcinoma are identified (see below the section under Long-term treatment).
Maltese: Voriconazole Accord għandu jitwaqqaf jekk jiġu identifikati leżjonijiet premalinni tal-ġilda jew karċinoma fiċċelluli skwamużi (ara hawn taħt is-sezzjoni Trattament fit-tul.
English: If phototoxic reactions occur multidisciplinary advice should be sought, Voriconazole Accord 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' Voriconazole Accord u l-użu ta' mediċini antifungali alternattivi għandu jiġi kkunsidrat u l-pazjent għandu jintbagħat għand dermatologu.
English: Short-acting opiates (CYP3A4 substrate)
Maltese: Opiates li jaħdmu fuq tul ta' żmien (substrat CYP3A4)
English: 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: • 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: Based on the population pharmacokinetic analysis, 12 to 14 year old adolescents weighing less than 50 kg should receive children's doses (sees ection4.2).
Maltese: Fuq bażi tal-analiżi farmakokinetika, adoloxxenti ta' bejn 12 u 14-il sena li jiżnu anqas minn 50 kg għandhom jingħataw dożi bħal dawk tat-tfal (ara sezzjoni 4.2).
English: B.PACKAGE LEAFLET
Maltese: Valur P
English: A higher frequency of liver enzyme elevations was observed in the paediatric population (see section 4.8).
Maltese: Frekwenza ikbar ta' żidiet fl-enzimi fil-fwied kienet osservata fil-popolazzjoni pedjatrika (ara sezzjoni 4.8).
English: Reminds patients of the risk of phototoxicity and skin SCC.
Maltese: - Ifakkar lil pazjenti dwar ir-riskju ta' fototossiċità u SCC tal-ġilda.
English: Voriconazo le (N=98)
Maltese: Punti tat-tmiem tal-istudju Voriconazole (N=98)
English: Breakthrough IFI - Day
Maltese: Monitoraġġ tal-funzjoni tal-fwied
English: 400 mg every 12 hours 200 mg every 12 hours
Maltese: 400 mg kull 12-il siegħa
English: Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term Voriconazole Accord treatment.
Maltese: Karċinoma fiċ-ċelluli skwamużi tal-ġilda (SCC) kienet irrappurtata f'pazjenti li rċivew trattament fittul ta' Voriconazole Accord.
English: When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored (see sections 4.4 and 4.5)
Maltese: Meta t-trattament b'voriconazole huwa mwaqqaf, id-dożaġġ tal-bidu ta' efavirenz għandu jkun mibdul għal li kien (ara sezzjojijiet 4.4 u 4.5).
English: It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh A and B) receiving voriconazole (see section 5.2).
Maltese: Huwa rakkomandat li jintużaw l-iskemi standard tad-doża inizjali aktar qawwija iżda li d-doża ta' manteniment titnaqqas bin-nofs f'pazjenti b'cirrożi tal-fwied ħafifa għal moderata (Child-Pugh A u B) li jkunu qegħdin jirċievu voriconazole (ara sezzjoni 5.2).
English: Coadministration of voriconazole and sirolimus is contraindicated (see section
Maltese: Amministrazzjoni ta' voriconazole flimkien ma' sirolimus hija kontraindikata (ara sezzjoni
English: PHARMACEUTICAL FORM
Maltese: Prodott Mediċinali
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 seħħew fil-passat.
English: Voriconazole Accord contains lactose
Maltese: Voriconazole Accord fih il-lactose
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' avvenimenti avversi assoċjati mat-trattament, it-twaqqif ta' voriconazole u l-użu ta' mediċini antifungali alternattivi għandu jiġi kkunsidrat (ara sezzjoni 4.4 u 4.8)
English: However, lower voriconazole exposure was observed in some young adolescents with low body weight compared to adults.
Maltese: Kienet osservata varjabilità akbar bejn persuna u oħra fil-pazjenti tfal meta mqabbla mal-adulti.