FrancophonIA/ELRC3.0 huggingface dataset:
English: PREVYMIS 240 mg film-coated tablets PREVYMIS 480 mg film-coated tablets letermovir
Maltese: PREVYMIS 240 mg pilloli miksijin b'rita PREVYMIS 480 mg pilloli miksijin b'rita letermovir
English: PREVYMIS 240 mg concentrate for solution for infusion PREVYMIS 480 mg concentrate for solution for infusion letermovir
Maltese: PREVYMIS 240 mg konċentrat għal soluzzjoni għall-infużjoni PREVYMIS 480 mg konċentrat għal soluzzjoni għall-infużjoni letermovir
English: (CYP2C9 induction)
Maltese: (induzzjoni ta' CYP2C9)
English: This should be taken into consideration by patients on a controlled sodium diet. PREVYMIS 480 mg concentrate for solution for infusion contains 46 mg (or 2.0 mmol) sodium per dose.
Maltese: PREVYMIS 480 mg konċentrat għal soluzzjoni għall-infużjoni fih 46 mg (jew 2.0 mmol) sodju għal kull doża.
English: General information about differences in exposure between different letermovir treatment regimens -The estimated letermovir plasma exposure is different depending on the dose regimen used (see table in section 5.2).
Maltese: Informazzjoni ġenerali dwar id-differenzi fl-esponiment bejn reġimens ta' kura differenti ta' letermovir -L-esponiment stmat ta' letermovir fil-plażma huwa differenti skont ir-reġimen tad-doża li jintuża (ara tabella f'sezzjoni 5.2).
English: -Examples of strong inducers include rifampicin, phenytoin, carbamazepine, St. John's wort (Hypericum perforatum), rifabutin and phenobarbital.
Maltese: John's wort (Hypericum perforatum), rifabutin u phenobarbital.
English: Multiple dose rifampicin decreases plasma concentrations of letermovir.
Maltese: Dożi multipli ta' rifampicin inaqqsu lkonċentrazzjonijiet ta' letermovir filplażma.
English: Letermovir may decrease the plasma concentrations of phenytoin.
Maltese: Letermovir jista' jnaqqas ilkonċentrazzjonijiet fil-plażma ta' phenytoin.
English: The major elimination pathways of letermovir is biliary excretion as well as direct glucuronidation.
Maltese: Il-passaġġi ta' eliminazzjoni maġġuri ta' letermovir huwa eskrezzjoni biljari kif ukoll glukuronidazzjoni diretta.
English: If you are taking PREVYMIS with cyclosporine, do not take the following medicines: o dabigatran - used for blood clots o atorvastatin, simvastatin, rosuvastatin, pitavastatin -for high cholesterol
Maltese: Jekk qed tieħu PREVYMIS ma' cyclosporine, tiħux il-mediċini li ġejjin: o dabigatran - jintuża għall-koagulazzjoni o atorvastatin, simvastatin, rosuvastatin, pitavastatin -għal kolesterol għoli
English: These antivirals may decrease plasma concentration of letermovir.
Maltese: Dawn l-antivirali jistgħu jnaqqsu lkonċentrazzjonijiet ta' letermovir filplażma.
English: Table 1: Interactions and dose recommendations with other medicinal products.
Maltese: Tabella 1: Interazzjonijiet u rakkomandazzjonijiet tad-doża ma' prodotti mediċinali oħra.
English: Missed dose
Maltese: Proporzjoni medju
English: ↔ fluconazole AUC 1.03 (0.99, 1.08) Cmax 0.95 (0.92, 0.99) ↔ letermovir AUC 1.11 (1.01, 1.23) Cmax 1.06 (0.93, 1.21)
Maltese: ↔ fluconazole AUC 1.03 (0.99, 1.08) Cmax 0.95 (0.92, 0.99)
English: Each 480 mg vial contains 46 mg sodium (main component of cooking/table salt).
Maltese: Kull kunjett ta' 480 mg fih 46 mg sodju (il-komponent ewlieni ta' melħ tat-tisjir/tal-ikel).
English: PREVYMIS 240 mg concentrate for solution for infusion PREVYMIS 480 mg concentrate for solution for infusion
Maltese: PREVYMIS 240 mg konċentrat għal soluzzjoni għall-infużjoni PREVYMIS 480 mg konċentrat għal soluzzjoni għall-infużjoni
English: Etravirine may decrease plasma concentrations of letermovir.
Maltese: Etravirine jista' jnaqqas ilkonċentrazzjonijiet ta' letermovir filplażma.
English: There was no testicular toxicity in rats at exposures (AUC) similar to the exposures in humans at the RHD.
Maltese: Ma kien hemm l-ebda tossiċità testikulari fil-firien f'esponimenti (AUC) simili għall-esponimenti fl-bniedmin bl-RHD.
English: Based on population pharmacokinetic analyses, there is no effect of age on letermovir pharmacokinetics.
Maltese: Abbażi ta' analiżijiet farmakokinetiċi tal-popolazzjoni, m'hemm l-ebda effett tal-età fuq ilfarmakokinetiċi ta' letermovir.
English: Letermovir affects the formation of proper unit length genomes and interferes with virion maturation.
Maltese: Letermovir jaffettwa l-formazzjoni ta' ġenomi ta' tul tal-unità xieraq u jinterferixxi mal-maturazzjoni tal-virjon.
English: Incompatible IV bags and infusion set materials PREVYMIS is incompatible with polyurethane-containing IV administration set tubing.
Maltese: Boroż tal-IV u materjali tas-sett tal-infużjoni inkompatibbli PREVYMIS huwa inkompatibbli ma' tubu tas-sett tal-għoti
English: This toxicity was characterized by seminiferous tubular degeneration, and oligospermia and cell debris in the epididymides, with decreased testicular and epididymides weights.
Maltese: Din it-tossiċità hija kkaratterizzata minn deġenerazzjoni tubulari seminiferuża, u oligospermja u frak taċ-ċelluli fl-epididimi, b'piżijiet imnaqqsa tat-testikoli u tal-epididimi.
English: Each 240 mg film-coated tablet contains less than 1 mmol sodium (23 mg).
Maltese: Kull 240 mg pillola miksija b'rita fiha inqas minn 1 mmol sodju (23 mg).
English: How to take PREVYMIS 4.
Maltese: Kif gћandek tieħu PREVYMIS 4.
English: Frequent monitoring of sirolimus whole blood concentrations should be performed during treatment, when changing PREVYMIS administration route, and at discontinuation of PREVYMIS and the dose of sirolimus adjusted accordingly Frequent monitoring of sirolimus concentrations is recommended at initiation or discontinuation of cyclosporine co administration with PREVYMIS.
Maltese: Huwa rakkomandat monitoraġġ frekwenti tal-konċentrazzjonijiet ta' sirolimus fil-bidu u meta jiwaqqaf l-għoti flimkien ta' cyclosporine ma' PREVYMIS.
English: (600 mg single dose PO)/ letermovir (480 mg single dose PO)
Maltese: (doża unika ta' 600 mg mill-ħalq)/ letermovir (doża unika ta' 480 mg mill-ħalq)
English: Nevirapine may decrease plasma concentrations of letermovir.
Maltese: Nevirapine jista' jnaqqas ilkonċentrazzjonijiet ta' letermovir filplażma.
English: Subjects were randomised (2:1) to receive either letermovir at a dose of 480 mg once daily adjusted to 240 mg when co-administered with cyclosporine, or placebo.
Maltese: Lindividwi ġew randomizzati (2:1) sabiex jirċievu jew letermovir f'doża ta' 480 mg darba kuljum aġġustata għal 240 mg meta jingħata flimkien ma' cyclosporine, jew plaċebo.
English: Co-administration of PREVYMIS and rifampicin is not recommended.
Maltese: L-għoti konkomitanti ta' PREVYMIS u rifampicin mhuwiex rakkomandat.
English: CYP2C9 is likely also induced.
Maltese: Aktarx li jiġi indott ukoll CYP2C9.
English: EC50 values for these mutations are 13- to 8,262-fold higher than those for the wild-type reference virus.
Maltese: Il-valuri EC50 għal dawn ilmutazzjonijiet huma 13- sa 8,262 darba ogħla minn dawk għall-virus ta' referenza tat-tip selvaġġ.
English: (primarily CYP3A inhibition and CYP2C8 inhibition or induction)
Maltese: (primarjament inibizzjoni ta' CYP3A u inibizzjoni jew induzzjoni ta' CYP2C8)
English: • allergic reaction (hypersensitivity) - the signs may include wheezing, difficulty breathing, rashes or hives, itchiness, swelling.
Maltese: • reazzjoni allerġika (sensittività eċċessiva) - is-sinjali jistgħu jinkludu tħarħir, diffikultà biex tieħu nifs, raxx jew ħorriqija, ħakk, nefħa.
English: Co-administration of PREVYMIS and carbamazepine or phenobarbital is not recommended.
Maltese: Prodotti mediċinali antiepilettiċi carbamazepine, phenobarbital
English: Among the 565 treated subjects, 373 subjects received letermovir (including 99 subjects who received at least one IV dose) and 192 received placebo (including 48 subjects who received at least one IV dose).
Maltese: Fost il-565 individwu kkurati, 373 individwu rċivew letermovir (inkluż 99 individwu li rċivew talinqas doża waħda
English: After dilution, PREVYMIS should be administered by intravenous infusion via peripheral or central venous catheter using a total time of approximately 60 minutes.
Maltese: Wara d-dilwizzjoni, PREVYMIS għandu jingħata b'infużjoni ġol-vini permezz ta' katerer ġol-vini periferali jew ċentrali waqt li tuża ħin totali ta' madwar 60 minuta.
English: This medicine contains less than 1 mmol sodium (23 mg) per 480 mg tablet, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodju (23 mg) għal kull pillola ta' 480 mg, għalhekk tista' tgħid li hi essenzjalment “mingħajr sodju”.
English: Contains lactose.
Maltese: sirolimus‡
English: • significant decrease of concomitant medicinal product plasma concentrations which may lead to reduced therapeutic effect of the concomitant medicinal product.
Maltese: • nuqqas kbir ta' konċentrazzjonijiet ta' prodotti mediċinali konkomitanti fil-plażma li jista' jwassal għal effett terapewtiku mnaqqas tal-prodott mediċinali konkomitanti.
English: Stratum-adjusted treatment difference (Letermovir
Maltese: Differenza fil-kura aġġustata skont l-istrat (Letermovir-Plaċebo)§
English: Each 240 mg vial contains 23 mg sodium (main component of cooking/table salt).
Maltese: Kull kunjett ta' 240 mg fih 23 mg sodju (il-komponent ewlieni ta' melħ tat-tisjir/tal-ikel).
English: Excretion
Maltese: PREVYMIS
English: posaconazole (300 mg single dose)/ letermovir (480 mg daily)
Maltese: rifampicin (doża unika ta' 600 mg mill-ħalq)/ letermovir (doża unika ta' 480 mg mill-ħalq)
English: (CYP2C9/19 induction)
Maltese: (Induzzjoni ta' CYP2C9/19)
English: Letermovir may decrease the plasma concentrations of dabigatran and may decrease efficacy of dabigatran.
Maltese: Letermovir jista' sostanzjalment iżid ilkonċentrazzjonijiet fil-plażma ta' dawn listatini.
English: • oral contraceptive steroids-for birth control
Maltese: • sterojdi kontraċettivi orali-għal kontroll tat-twelid
English: In HSCT recipients, co-administration of cyclosporine increased plasma concentrations of letermovir due to inhibition of OATP1B.
Maltese: F'riċevituri ta' HSCT, l-għoti flimkien ta' cyclosporine żied il-konċentrazzjonijiet fil-plażma ta' letermovir minħabba l-inibizzjoni ta' OATP1B.
English: Compatible intravenous bags and infusion set materials
Maltese: Boroż intravenużi u materjali tas-sett tal-infużjoni
English: 1 glass container + 1 oral applicator + 1 transfer adapter
Maltese: Kontenitur tal-ħġieġ 1 + applikatur tal-ħalq 1 + 1 transfer adapter
English: 1 squeezable tube multi-monodose (5 single dose) squeezable tube (polyethylene) presentation connected by a bar
Maltese: Preżentazzjoni ta' tubu (polyethylene) 'multimonodose' (5 doża waħda) li jingħafas imqabbad minn bar
English: --¹ not less than 10E6.0 CCID50
Maltese: CCID50
English: 1 mg corresponds to 18.2 EAU*.
Maltese: 1 mg tikkorrispondi għal 18.2 EAU*.
English: - Convulsion**
Maltese: - Konvulżjoni**
English: Sanofi Chimie Route d'Avignon 30390 Aramon France
Maltese: Sanofi Chimie Route d'Avignon 30390 Aramon Franza
English: Via Valcanello, 4 03012 Anagni (FR) Italy
Maltese: Località Via Valcanello, 4 03012 Anagni (FR)
English: - Bronchospasm - Rhinitis
Maltese: - Bronkospażmu - Rinite
English: - The active substance is rasburicase 1.5 mg/ml.
Maltese: - Is-sustanza attiva hi rasburicase 1.5 mg/ml.
English: C.
Maltese: B.
English: - Diarrhoea + - Vomiting++ - Nausea++
Maltese: - Dijarea + - Rimettar++ - Dardir++
English: - Haemolysis - Haemolytic anaemia
Maltese: - Emolisi - Anemija emolitika
English: - Fever++
Maltese: - Deni++
English: - Muscle contraction involuntary**
Maltese: - Ġbid involontarju tal-muskolu**
English: Rasburicase is a protein, and therefore: 1) not expected to bind to proteins, 2) expected that metabolic degradation will follow the pathways of other proteins, i.e. peptide hydrolysis, 3) unlikely to be candidate for drug-drug interactions.
Maltese: Metaboliżmu Rasburicase hija proteina u għalhekk: 1) mhix mistennija li taqbad mal-proteini, 2) id-degradazzjoni metabolika hija mistennija li issegwi fil-linja ta' proteini oħra, i.e. idrolisi tal-peptide 3) u mhux probabbli li tkun involuta f'interazzjonijiet ma' sustanzi mediċinali oħra.
English: Methaemoglobina emia
Maltese: Metemoglobinemija
English: It will be given once a day, for up to 7 days.
Maltese: Ser tingħata darba kuljum, sa 7 ijiem.
English: Magyarország sanofi-aventis zrt.
Maltese: Magyarország sanofi-aventis zrt., Tel.:
English: *One enzyme activity unit (EAU) corresponds to the enzyme activity that converts 1 µmol of uric acid into allantoin per minute under the operating conditions described: +30 °C ± 1 °C TEA pH 8.9 buffer.
Maltese: *Unità waħda t'attività enzimali (EAU) tikkorrispondi għal attività enzimali li tittrasforma 1 µmol ta' aċidu uriku f'allantoina kull minuta taħt il-kundizzjonijiet applikabbli: +30 °Ċ ±1 °Ċ TEA pH 8.9
English: Powder: alanine mannitol disodium phosphate dodecahydrate disodium phosphate dihydrate sodium dihydrogen phosphate dihydrate
Maltese: Trab: alanine mannitol disodium phosphate dodecahydrate disodium phosphate dihydrate sodium dihydrogen phosphate dihydrate
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/170/001-002
Maltese: EU/1/00/170/001-002
English: In a randomized (1:1:1), multi-center, open-label study, 275 adult patients with leukemia and lymphoma at risk for hyperuricemia and tumour lysis syndrome (TLS) were treated with either rasburicase at a dose of 0.2 mg/kg/day, intravenously, for 5 days (arm A: n=92), rasburicase at a dose of 0.2 mg/kg/day, intravenously, from day 1 through day 3 followed by oral allopurinol at a dose of 300 mg once a day from day 3 through day 5 (overlap on day 3: rasburicase and allopurinol administered approximately 12 hours apart) (arm B: n=92), or oral allopurinol at a dose of 300 mg once a day for 5 days (arm C: n=91).
Maltese: F'studju open-label, magħmul b'mod arbitrarju (1:1:1) u li sar f'ċentri differenti, 275 pazjent adult, b'lewkimja u limfoma u f'riskju li jkollhom livell għoli ta' aċidu uriku fid-demm u ta' tumour lysis syndrome (TLS), ġew ikkurati jew b'rasburicase b'doża ta'0.2 mg/kg/ġurnata, minn ġol-vini, għal 5 ijiem (fergħa A: n=92), jew b'rasburicase b'doża ta' 0.2 mg/kg/ġurnata, minn ġol-vini, mill-ewwel ġurnata sat-3 ġurnata imbagħad tkompli b'allopurinol mill-ħalq b'doża ta' 300 mg darba kuljum mit3 ġurnata sal-5 ġurnata (il-koinċidenza fit-3 ġurnata: rasburicase u allopurinol jingħataw b'madwar 12il siegħa il-bogħod minn xulxin) (fergħa B: n=92), jew allopurinol b'doża ta' 300 mg darba kuljum għal 5 ijiem (fergħa Ċ: n=91).
English: The recommended dose for Fasturtec is 0.20 mg/kg/day.
Maltese: Id-doża irrakkomandata ta' Fasturtec hija ta 0.20 mg/kg/jum.
English: Rasburicase is produced by genetechnology in a microorganism named Saccharomyces cerevisiae.
Maltese: Rasburicase hija magħmula b' teknoloġija ġenetika f'mikro-organiżmu msemmi Saccharomyces cerevisiae.
English: Batch
Maltese: baffer.
English: Infusion: The final solution should be infused over 30 minutes.
Maltese: Is-soluzzjoni finali trid tingħata permezz ta' infużjoni fuq perijodu ta' 30 minuta.
English: In adults (≥ the age of 18 years), age, gender, baseline liver enzymes and creatinine clearance did not impact the pharmacokinetics of rasburicase.
Maltese: Fl-adulti (> mill-età ta' 18-il sena), l-età, is-sess, il-livell bażilari tal-enzimi tal-fwied u t-tneħħija talkreatinina ma kellhom ebda effett fuq il-farmakokinetika ta' rasburicase.
English: The mean volume of distribution ranged from 110 - 127 ml/kg in paediatric patients and from 75.8 to 138 ml/kg in adult patients, respectively, which is comparable to the physiological vascular volume.
Maltese: F'pazjenti pedjatriċi, il-volum medju ta' distribuzzjoni kien bejn 110 - 127 ml/kg u bejn 75.8 sa 138 ml/kg f'pazjenti adulti, rispettivament, li huwa komparabbli mal-volum vaskulari fisjoloġiku.
English: The solvent contains no preservative.
Maltese: Is-solvent ma fih ebda preservattiv.
English: Frequencies are defined using the following MedDRA convention as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: In pivotal clinical studies, 246 paediatric patients ( mean age 7 years, range 0 to17) were treated with rasburicase at doses of 0.15 mg/kg/day or 0.20 mg/kg/day for 1 to 8 days (mainly 5 to 7 days).
Maltese: Fi studji kliniċi pivitali, 246 pazjent pedjatriku (età medja ta' 7 snin, marġni ta' etajiet minn 0 sa 17) ġew ittrattati bi rasburicase f'dożi ta' 0.15 mg/kg/jum jew 0.20mg/kg/jum għal 1 sa 8 ijiem (prinċipalment 5 sa 7 ijiem).
English: STATEMENT OF ACTIVE SUBSTANCE(S) rasburicase 7.5 mg/5 ml rasburicase produced by genetechnology in Saccharomyces cerevisiae strain
Maltese: ATTIVA(I) rasburicase 7.5 mg/5 ml rasburicase magħmul b'teknoloġija ġenetika f'razza ta' Saccharomyces cerevisiae
English: - Severe hypersensitivity reactions
Maltese: - Reazzjonijiet severi ta' sensittività eċċessiva
English: Solvent: poloxamer 188, water for injection.
Maltese: Solvent: poloxamer 188, ilma għall-injezzjoni.
English: Fasturtec is not directly effective in the treatment of these abnormalities.
Maltese: Fasturtec mhux direttament effettiv fit-trattament ta' dawn l-abnormalitajiet.
English: Clinical experience with Fasturtec demonstrates that patients should be closely monitored for the onset of allergic-type undesirable effects, especially severe hypersensitivity reactions including anaphylaxis (see section 4.8).
Maltese: Fasturtec turi li l-pazjenti għandhom ikunu immoniterjati sew għall-iżvilupp ta' effetti ta' natura allerġika mhux mixtieqa, specjalment reazzjonijiet ta' sensittività eċċessiva severa li jinkludu lanafilassi (ara sezzjoni 4.8).
English: At 4 hours post first dose, there was a significant difference in the mean percentage change from baseline plasma uric acid concentration (p <0.0001) in the Fasturtec group (86.0%) compared to that for the allopurinol group (-12.1%).
Maltese: Wara 4 sigħat mit-teħid ta' l-ewwel doża, kien hemm differenza sinifikanti filmedja perċentwali tal-bidla minn dik bażika, fil-livell ta' l-aċidu uriku fil-plażma (p < 0.0001), filgrupp li ħa Fasturtec (-86.0%), meta mqabbel ma' dak il-grupp li ħa allopurinol (-12.1%).
English: Solvent: poloxamer 188 water for injection
Maltese: Solvent: poloxamer 188 ilma għall-injezzjoni
English: (methaemoglobinaemia) - fits (convulsion).
Maltese: - aċċessjonijiet (konvulżjoni)
English: 7.5 mg/5 ml
Maltese: INDIVIDWALI 7.5 mg
English: STATEMENT OF ACTIVE SUBSTANCE(S) rasburicase 1.5 mg/1 ml rasburicase produced by genetechnology in Saccharomyces cerevisiae strain
Maltese: ATTIVA(I) rasburicase 1.5 mg/1 ml rasburicase magħmul b'teknoloġija ġenetika f'razza ta' Saccharomyces cerevisiae
English: - Hypotension
Maltese: -Allerġija /
English: Efficacy results on 229 evaluable patients showed an overall response rate (normalization of plasma uric acid levels) of 96.1%.
Maltese: rispons totali (normalizzazzjoni tal-livelli ta' l-aċidu uriku fil-plażma) ta' 96.1%.
English: Fasturtec is administered as a once daily 30 minute intravenous infusion in 50 ml of a sodium chloride 9 mg/ml (0.9%) solution (see section
Maltese: permezz ta' infużjoni fil-vini tul 30 minuta, f'50 ml ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9%) (ara sezzjoni 6.6).
English: Rasburicase solution should be infused over 30 minutes.
Maltese: Is-soluzzjoni ta' rasburicase trid tingħata bħala infuzzjoni f'perijodu ta' 30 minuta.
English: Powder also contains: alanine, mannitol, disodium phosphate dodecahydrate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.
Maltese: It-trab fih ukoll: alanine, mannitol, disodium phosphate dodecahydrate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.
English: Other medicines and Fasturtec
Maltese: Mediċini oħra u Fasturtec
English: In healthy volunteers, a marked dose-related decrease in plasma uric acid levels was observed across the dose range 0.05 mg/kg to 0.20 mg/kg of Fasturtec.
Maltese: F'voluntiera b'saħħithom, kien innotat tnaqqis fil-livelli ta' l-aċidu uriku fil-plażma, li kien jidher ċar li huwa relatat mad-daqs tad-doża użata, ġewwa firxa ta' 0.05 mg/kg sa 0.20 mg/kg ta' Fasturtec.
English: Date of latest renewal: 23 February 2006
Maltese: Data tal-aħħar tiġdid: 23 ta' Frar, 2006
English: * Anaphylactic shock including potential fatal outcome ** From post-marketing experience + Uncommon G3/4 ++ Common G3/4
Maltese: * Xokk anafilattiku li jinkludi avveniment li jista' jkun fatali ** Mill-esperjenza wara li l-prodott tqiegħed fis-suq + Mhux komuni G3/4 ++ Komuni G3/4
English: In a randomised comparative phase III study, performed in 52 paediatric patients, 27 patients were treated with rasburicase at the recommended dose of 0.20 mg/kg/day, intravenously, for 4 to 7 days (< 5 years: n=11; 6-12 years: n=11; 13-17 years: n=5), and 25 patients with allopurinol daily oral doses for 4 to 8 days.
Maltese: III, magħmul f'52 pazjent pedjatriku, 27 pazjent ġew ikkurati b'rasburicase bid-doża rakkomandata ta' 0.20 mg/kg/jum, mogħti minn ġol-vini, għal 4 sa 7 ijiem (< 5 snin: n=11; 6-12-il sena: n=11; 13-17-il sena: n=5) u 25 pazjent ikkurati b'dożi ta' kuljum ta' allopurinol għal 4
English: The acute increase in plasma levels of uric acid subsequent to the lysis of large numbers of malignant cells and during cytoreductive chemotherapy may lead to impairment of renal function and renal failure resulting from the precipitation of crystals of uric acid in renal tubules.
Maltese: Il-livelli għolja u akuti ta' l-aċidu uriku fil-plażma, dovuti għad-diżintegrazzjoni ta' numri kbar ta' ċelluli malinni waqt il-kimoterapija riduttiva ċellulari, jistgħu jwasslu għall-indeboliment tal-funzjoni renali u nsuffiċjenza renali, li huwa dovut ghad-depożitu ta' kristalli ta' l-aċidu uriku fit-tubuli renali.
English: Pack of 1 vial of 7.5 mg rasburicase and 1 ampoule of 5 ml solvent.
Maltese: Pakkett ta' kunjett 1 ta' 7.5 mg rasburicase u ampulla 1 ta' 5 ml solvent.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/170/001
Maltese: EU/1/00/170/001
English: The safety results of patients treated with Fasturtec in Study EFC4978 were consistent with the adverse events profile observed in previous clinical studies with predominantly paediatric patients.
Maltese: Ir-riżultati ta' sigurtà fil-pazjenti kkurati b'Fasturtec fl-Studju EFC4978 kienu konsistenti mal-profil ta' avvenimenti avversi li dehru f'studji kliniċi preċedenti, fejn il-parti l-kbira tal-pazjenti kienu dawk pedjatriċi.
English: 1 vial of 7.5 mg rasburicase and 1 ampoule of 5 ml solvent.
Maltese: Kunjett 1 ta' 7.5 mg rasburicase u ampulla 1 ta' 5 ml solvent.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Fasturtec is a recombinant urate-oxidase enzyme produced by genetically modified Saccharomyces cerevisiae strain.
Maltese: Fasturtec huwa enzima rikombinata ta' urate-oxidase, prodotta minn razza ta' Saccharomyces cerevisiae ġenetikament modifikata.
English: Clearance is increased (ca. 35%) in children and adolescents compared to adults, resulting in a lower systemic exposure.
Maltese: It-tneħijja hija aktar mgħaġġla (madwar 35%) fit-tfal u l-adoloxxenti, meta mqabbla ma' l-adulti, bil-konsegwenza li hemm anqas espożizzjoni sistemika.
English: Rasburicase is a tetrameric protein with identical subunits of a molecular mass of about 34 kDa.
Maltese: massa molekulari ta' madwar 34 kDa.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 1 POWDER VIAL and 1 SOLVENT AMPOULE
Maltese: PAKKETT TA' KUNJETT 1 BIT-TRAB u AMPULLA 1 BIS-SOLVENT
English: How to store Fasturtec
Maltese: X'fih Fasturtec
English: • rash, itching or hives (nettle-type rash) on the skin
Maltese: • raxx, ħakk jew ħorriqija (raxx tat-tip ta' urtikarja) fuq il-ġilda
English: - The other ingredients of the solvent are: poloxamer 188, water for injection.
Maltese: - Is-sustanzi l-oħra tas-solvent huma: poloxamer 188, ilma għall-injezzjoni.
English: Safety results on 246 patients were consistent with the adverse events profile in the overall population.
Maltese: Ir-riżultati tassigurta' fuq 246 pazjent kienu konsistenti mal-profil tar-reazzjonijiet avversi fil-popolazzjoni totali.