qanastek/EMEA-V3 huggingface dataset:
Fasturtec should not be used in patients with a deficiency in glucose-6-phosphate dehydrogenase (G6PD) or other metabolic disorders known to cause haemolytic anaemia (low red blood cell counts, caused by the cells being destroyed too soon).
Fasturtec m’ għandux jintuża minn pazjeti b’ defiċjenza tal- glucose- 6- phosphate dehydrogenase (G6PD) jew diżordnijiet metaboliċi oħra magħrufa li jikkwżaw anemija analitika (għadd baxx ta ’ ċelloli tad- demm ħomor, ikkawżati mit- tkissir malajr wisq taċ- ċelloli).
Why has Fasturtec been approved?
Għaliex ġie approvat Fasturtec?
The Committee for Medicinal products for Human Use (CHMP) decided that Fasturtec’ s benefits are greater than its risks for the treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in patients with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.
Il- Kumitat għall- prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Fasturtec huma ikbar mir- riskju tiegħu fit- trattament u l- prevenzjoni ta ’ iperuriċemija akuta, biex ikun evitat il- falliment akut tal- kliewi, f’ pazjenti b’ tibdiliet malinni ematoloġiċi b’ piż kbir ta ’ tumur u f’ riskju li t- tumur jinkiser jew jinxtrob malajr hekk kif tinbeda l- kimoterapija.
The Committee recommended that Fasturtec be given marketing authorisation.
Il- Kumitat irrakkomanda li Fasturtec jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Fasturtec:
Tagħrif ieħor dwar Fasturtec:
The European Commission granted a marketing authorisation valid throughout the European Union for Fasturtec to sanofi-aventis on 23 February 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Fasturtec lil sanofi- aventis fit- 23 ta ’ Frar 2001.
The marketing authorisation was renewed on 23 February 2006.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 23 ta ’ Frar 2006.
The full EPAR for Fasturtec is available here.
L- EPAR sħiħ għal Fasturtec huwa disponibbli minn hawnhekk.
Fasturtec 1.5 mg/ ml powder and solvent for concentrate for solution for infusion.
Fasturtec 1. 5 mg/ ml trab u solvent għall- konċentrat għal soluzzjoni għall- infużjoni.
After reconstitution, 1 ml of Fasturtec concentrate contains 1.5 mg rasburicase.
Wara r- rikostituzzjoni, 1 ml ta ’ Fasturtec konċentrat fih 1. 5 mg ta ’ rasburicase.
Fasturtec is a recombinant urate-oxidase enzyme produced by genetically modified Saccharomyces cerevisiae strain.
Fasturtec huwa enzima rikombinata ta ’ urate- oxidase, prodotta minn razza ta ’ Saccharomyces cerevisiae ġenetikament modifikata.
Rasburicase is a tetrameric protein with identical subunits of a molecular mass of about 34 kDa.
Rasburicase hija proteina tetramerika, b’ subunitajiet identiċi, ta ’ massa molekulari ta ’ madwar 34 kDa.
1 mg corresponds to 18.2 EAU*.
1 mg tikkorrispondi għal 18. 2 EAU *.
*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.
* 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 baffer.
Powder and solvent for concentrate for solution for infusion.
Trab u solvent għall- konċentrat għal soluzzjoni għall- infużjoni.
The powder is an entire or broken white to off white pellet.
It- trab huwa taħt għamla ta ’ pritkuna sħiħa jew miksura ta ’ kulur abjad għal offwajt.
The solvent is a colourless and clear liquid.
Is- solvent huwa likwidu mingħajr kulur u ċar.
Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in patients with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.
Għat- trattament u profilassi ta ’ stat akut ta ’ livell għoli ta ’ aċidu uriku fid- demm, biex jimpedixxi l - iżvilupp ta ’ insuffiċjenza renali akuta, f’ pazjenti li għandhom tumur malinn tad- demm, b’ tumur kbir jew estensiv, u f’ riskju li jiżviluppaw diżintegrazzjoni mgħaġġla tat- tumur jew nixfa tat- tumur, fil- bidu tal- kimoterapija.
Posology and method of administration
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
Fasturtec should be administered under the supervision of a physician trained in chemotherapy of haematological malignancies.
Fasturtec għandu jingħata taħt is- sorveljanza ta ’ tabib imħarreġ fil- kimoterapija tat- tumuri malinni tad- demm.
Fasturtec is to be used immediately prior to and during the initiation of chemotherapy only, as at the present, there is insufficient data to recommend multiple treatment courses.
Fasturtec għandu jintuża immedjatament qabel u fil- bidu biss tal- kimoterapija, għax fil- preżent, m’ hemmx data biżżejjed biex korsijiet ripetuti ta ’ trattament ikunu irrakkomandati.
The recommended dose for Fasturtec is 0.20 mg/ kg/ day.
Id- doża irrakkomandata ta ’ Fasturtec hija ta 0. 20 mg/ kg/ jum.
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 6.6).
Fasturtec jingħata darba kuljum, 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).
The duration of treatment with Fasturtec may be up to 7 days, the exact duration should be based upon adequate monitoring of uric acid levels in plasma and clinical judgment.
It- tul ta ’ żmien tal- kura bil- Fasturtec tista ’ tkun ta ’ 7 jiem, imsejsa fuq l- immoniteraġġ tal- livelli ta ’ l - aċidu uriku fil- plażma u fuq il- ġudizzju kliniku.
Administration of rasburicase does not require any change in the timing or schedule of initiation of cytoreductive chemotherapy.
2 Meta jingħata rasburicase m’ hemmx bżonn ta ’ bidla fil- ħin jew fl- iskeda ta ’ l- introduzzjoni tal - kimoterapija li tnaqqas in- numru taċ- ċelluli.
Rasburicase solution should be infused over 30 minutes.
Is- soluzzjoni ta ’ rasburicase trid tingħata bħala infuzzjoni f’ perijodu ta ’ 30 minuta.
If use of a separate line is not possible, the line should be flushed out with saline
L- infużjoni tas - soluzzjoni ta ’ rasburicase trid tingħata minn kateter għal ġol- vini, separat minn dak użat għall - infużjoni tas- sustanzi mediċinali kimoterapewtiċi, biex tkun eliminata kull possibbiltà ta ’ nuqqas ta ’ inkompattibbiltà bejn il- prodotti.
2 solution between infusion of chemotherapeutic agents and rasburicase.
Jekk mhux possibbli li jintuża kateter għal ġol- vini differenti, il- pajp għandu jiġi ifflaxjat b ’ soluzzjoni ta ’ salina bejn l- infużjoni tal- prodotti kimoterapewtiċi u rasburicase.
For instruction on use, see section 6.6.
Dwar l- istruzzjoni fuq l- użu, ara sezzjoni 6. 6.
Because rasburicase may degrade uric acid in vitro, special precautions must be used during sample handling for plasma uric acid measurements, see section 6.6.
Peress li rasburicase jista ’ jiddegrada l- aċidu uriku in vitro, miżuri speċjali għandhom jittieħdu waqt l - immaniġġar ta ’ kampjuni tal- plażma meta jitkejjel il- livell ta ’ l- aċidu uriku, ara sezzjoni 6. 6.
Additional information on special populations Renally or hepatically impaired patients:
Informazzjoni addizzjonali fuq gruppi speċjali tal- popolazzjoni Pazjenti li għandhom indeboliment renali jew tal- fwied:
No dose adjustment is necessary.
M’ hemmx bżonn li jsir aġġustament fid- doża.
As no adjustment is necessary, the recommended dose is 0.20 mg/ kg/ day.
Għalkemm m’ hemmx bżonn aġġustament, id- doża rrakkomandata hija ta ’ 0. 20 mg/ kg/ jum
G6PD deficiency and other cellular metabolic disorders known to cause haemolytic anaemia.
In- nuqqas ta ’ G6PD u mard metaboliku cellulari ieħor, li huma magħrufin li jikkawżaw l- anemija emolitika.
Hydrogen peroxide is a by-product of the conversion of uric acid to allantoin.
Hydrogen peroxide hija prodott sekondarju fil- bidla ta ’ l- aċidu uriku għall- allantoina.
In order to prevent possible haemolytic anaemia induced by hydrogen peroxide, rasburicase is contraindicated in patients with these disorders.
Biex tkun ipprevenuta l- possibbiltà ta ’ l- anemija emolitika indotta mill- hydrogen peroxide, rasburicase hija kontra- indikata f’ pazjenti b’ dawn il- kondizzjonijiet.
Rasburicase like other proteins, has the potential to induce allergic responses in humans.
Rasburicase bħal proteini oħra, ghandha l- potenzjal li tinduċi reazzjonijiet allerġiċi fil- bniedem.
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).
L - esperjenza klinika b ’ 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 l- anafilassi (ara sezzjoni 4. 8).
In such cases, treatment should immediately and permanently be discontinued and appropriate therapy initiated.
F ’ tali każijiet, it- trattament għandu jitwaqqaf immedjatament u permanentement u r- rimedji terapewtiċi jinbdew.
Caution should be used in patients with a history of atopic allergies.
Trid tittieħed il- kawtela f’ pazjent bi storja ta ’ forom ta ’ allerġija ġenetikament predisposta.
At present, there is insufficient data available on patients being retreated to recommend multiple treatment courses.
Fil- preżent, m’ hemmx data biżżejjed fuq pazjenti li qed ikunu jerġgħu ttrattati biex jistgħu jiġu rrakkomandati korsijiet ripetuti ta ’ kura.
Anti-rasburicase antibodies have been detected in treated patients and healthy volunteers administered rasburicase.
L- antikorpi kontra rasburicase nstabu f’ pazjenti ttrattati, u voluntiera b’ saħħithom li ngħataw rasburicase.
Methaemoglobinaemia has been reported in patients receiving Fasturtec.
Il- metemoglobinemija ġiet irrapportata f’ pazjenti li ħadu Fasturtec.
Fasturtec should immediately and permanently be discontinued in patients having developed methaemoglobinaemia, and appropriate measures initiated (see section 4.8).
Fasturtec għandu jitwaqqaf immedjatament u permanentement f’ dawk il- pazjenti li jiżviluppaw il- metemoglobinemija, u għandhom jittieħdu l- miżuri xierqa (ara sezzjoni 4. 8).
Haemolysis has been reported in patients receiving Fasturtec.
L- emolisi ġiet irrapportata f’ pazjenti li rċevew Fasturtec.
In such case, treatment should immediately and permanently be discontinued and appropriate measures initiated (see section 4.8).
F’ każijiet bhal dawn, it- trattament għandu jitwaqqaf immedjatament u permanentement, u għandhom jittieħdu il- miżuri xierqa (ara sezzjoni 4. 8).
Administration of Fasturtec reduces the uric acid levels to below normal levels and by this mechanism reduces the chance of development of renal failure due to precipitation of uric acid crystals in renal tubules as a consequence of hyperuricaemia.
Meta Fasturtec jingħata, dan inaqqas il- livelli ta ’ l- aċidu uriku ’ l isfel minn dawk normali u b’ dan il - mekkaniżmu jnaqqas il- possibbiltà ta ’ l- iżvilupp ta ’ insuffiċjenza renali dovut għal depożitu ta ’ kristalli ta ’ l- aċidu uriku fit- tubuli renali, bħala konsegwenza ta ’ livelli għolja, aktar minn normal, ta ’ l- aċidu uriku fid- demm.
Tumour lysis can also result in hyperphosphataemia, hyperkalaemia and hypocalcaemia.
Id- diżintegrazzjoni tat- tumur jista ’ ukoll iwassal għal livelli għolja ta ’ fosfat, potassju u l- kalċju.
Fasturtec is not directly effective in the treatment of these abnormalities.
Fasturtec mhux direttament effettiv fit- trattament ta ’ dawn l- abnormalitajiet.
Therefore, patients must be monitored closely.
Għalħekk, il- pazjenti jridu jkunu immoniterjati sew.
Fasturtec has not been investigated in the patients with hyperuricemia in the context of myeloproliferative disorders.
Fasturtec ma ġiex investigat f’ pazjenti b’ livell għoli ta ’ acidu uriku fid- demm aktar minn dak normali, fil- kuntest ta ’ dak il- grupp ta ’ mard ikkaratterizzat minn proliferazzjoni tat- tessut tal- mudullun.
There is no data available to recommend the sequential use of Fasturtec and allopurinol.
3 M’ hemmx data disponibbli biex wieħed jirrakkomanda l- użu sekwenzjali ta ’ Fasturtec u allopurinol.
To ensure accurate measurement of uric acid plasma level during treatment with Fasturtec, a strict sample handling procedure must be followed (see section 6.6).
Biex jiġi assikurat il- kejl eżatt tal- livell ta ’ l- aċidu uriku fil- plażma, waqt it- trattament b’ Fasturtec, huwa meħtieġ li tkun segwita proċedura stretta fl- immaniġġjar tal- kampjun (ara sezzjoni 6. 6).
No metabolism studies have been performed.
Ma sarux studji dwar il- metaboliżmu.
Rasburicase being an enzyme itself, it would be an unlikely candidate for drug-drug interactions.
Peress li rasburicase hija enzima fiha innifisha, huwa improbabbli li tkun involuta f’ interazzjoni ma ’ medicina oħra.
3 4.6 Pregnancy and lactation
Studji fuq il- bhejjem b’ referenza għall- effetti fuq it- twelid u żvilupp wara t- twelid, ma sarux (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Ir- riskju ki jista jkun hemm fuq in- nies, mhux magħruf.
Fasturtec should not be used during pregnancy or in breast- feeding women.
Fasturtec m’ għandux jintuża fit- tqala jew fin- nisa li qed ireddgħu.
It is unknown whether rasburicase is excreted in human milk.
Mhux magħruf jekk rasburicase jaqsamx fil- ħalib tal- mara.
Fasturtec is concomitantly administered as supportive care to cytoreductive chemotherapy of advanced malignancies, the causality of adverse events is therefore difficult to assess due to the significant burden of adverse events expected from the underlying disease and its treatment.
Fasturtec jingħata flimkien mal- kimoterapija intiża biex tnaqqas in- numru ta’ ċelluli ta ’ tumuri malinni avvanzati, għalhekk, il- kawżalità ta ’ ġrajjiet avversi hija diffiċili li tkun assessjata mħabba l- piż sinifikanti tal- ġrajjiet avversi mistennija mill- marda innifisha u t- trattament tagħha.
The most significant drug-related adverse events were common allergic reactions, mainly rashes and urticaria.
Il- ġrajjiet avversi, relatati ma ’ l- użu ta ’ din il- mediċina, li kienu l- aktar sinifikanti kienu reazzjonijiet allerġiċi komuni, prinċipalment raxxijiet tal- ġilda u urtikarja.
Cases of hypotension (< 1%), bronchospasm (< 1%), rhinitis (< 0.1%) and severe hypersensitivity reactions (< 1%), including anaphylaxis (< 0.1%) have also been attributed to Fasturtec.
Kazijiet ta ’ pressjoni baxxa (< 1%), attakki f’ daqqa waħda ta ’ djuq tal- bronki (< 1%), infjammazzjoni ta ’ l- imnifsejn (< 0. 1%) u reazzjonijiet ta ’ sensittività eċċessiva (< 1%), li tinkludi l- anafilassi (< 0. 1%), kienu ukoll attribwiti għal Fasturtec.
The enzymatic digestion of uric acid to allantoin by rasburicase produces hydrogen peroxide and haemolytic anaemia or methaemoglobinaemia have been observed in certain at risk populations such as those with G6PD deficiency.
Fi provi klinici, il- mard ematologiku bhall- emolisi, l- anemija emolitika, u l- metemoglobinemija, mhux komunement ikkawżati minn Fasturtec Id- diġestjoni enzimatika ta ’ rasburicase fuq l- aċidu uriku, li jinbidel fl- allantoina u jipproduċi hydrogen peroxide u l- anemija emolitika, jew il- metemoglobinemija, deheret f’ ċerti gruppi riskjużi tal- popolazzjoni, bħal dawk li jbatu minn nuqqas ta ’ G6PD.
In addition, grade 3 or 4 adverse reactions possibly attributable to Fasturtec and reported in the clinical trials, are listed below, by system organ class and by frequency.
Addizzjonalment, reazzjonijiet avversi ta ’ grad 3 jew 4, possibbilment attribwiti għal Fasturtec, kienu rrapportati fi provi kliniċi; ara l- lista elenkata hawn taħt, ikklassifikati skond l- organi u l- frekwenza.
Frequencies are defined as: common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1,000, < 1/ 100).
Il - frekwenzi huma mfissra hekk: komuni (≥ 1/ 100, < 1/ 10) u mhux komuni (≥ 1/ 1, 000, < 1/ 100).
Uncommon Headache Diarrhoea
Mhux Komuni Ugigħ ta ’ ras Dijarea
Gastrointestinal disorders General disorders and administration site conditions
Disturbi gastro- intestinali Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Vomiting Nausea
Rimettar Dardir
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom bl- aktar serji jitniżżlu l- ewwel.
4.9 Overdose
4 4. 9 Doża eċċessiva
In view of the mechanism of action of Fasturtec, an overdose will lead to low or undetectable plasma uric acid concentrations and increased production of hydrogen peroxide.
Minħabba l- mekkaniżmu ta ’ kif jaħdem Fasturtec, doża eċċessiva twassal ghall- livelli baxxi jew assenti ta ’ l- aċidu uriku fil- plażma u formazzjoni aktar ta ’ hydrogen peroxide.
Thus patients suspected of receiving an overdose should be monitored for haemolysis, and general supportive measures should be initiated as no specific antidote for Fasturtec has been identified.
Għalhekk, il- pazjenti maħsuba li rċevew doża eċċessiva għandhom ikunu mmoniterjati għall- emolisi, u għandhom jittieħdu l- miżuri ġenerali ta ’ sostenn peress li m’ hemmx antidot speċifiku magħruf għal Fasturtec.
Detoxifying agents for antineoplastic treatment, ATC code:
Mediċini detossifikanti għat- trattament kontra n- neoplażmi, kodiċi ATC:
The acute increase in plasma
Fil- bniedem, l- aċidu uriku huwa l- prodott finali fil- proċess kataboliku tal- purini.
4 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.
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.
Rasburicase is a highly potent uricolytic agent that catalyses enzymatic oxidation of uric acid into allantoin, a water soluble product, easily excreted by the kidneys in the urine.
Rasburicase huwa tip ta ’ mediċina qawwija ħafna, li tattakka l- aċidu uriku permess ta ’ katalisi ossidattiva enzimatika, li twassal fil- bidla ta ’ l- aċidu uriku fl- allantoina, prodott li jinħall fl- ilma, u li jitneħħa faċilment fl- urina ġejja mill- kliewi.
The enzymatic oxidation of uric acid leads to stoichiometric formation of hydrogen peroxide.
L- ossidazzjoni enzimatika ta ’ l- aċidu uriku jwassal għall- ifformar stojkjometriku ta ’ hydrogen peroxide.
The increased of hydrogen peroxide over ambient levels can be eliminated by endogenous antioxidants and the only increased risk is for haemolysis in G6PD deficient and inherited anaemia patients.
Iż- żieda ta ’ hydrogen peroxide, fuq il- livelli ambjentali, jista ’ jitneħħa permezz t’ antiossidanti naturali, li jinsabu fil- ġisem, u l- uniku riskju żejjed huwa l- emolisi f’ dawk li għandhom nuqqas ta ’ G6PD, u pazjenti li jbatu minn anemija ereditarja.
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.
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.
A randomised comparative phase III study, using the recommended dose, showed a significantly more rapid onset of action of Fasturtec in comparison with allopurinol.
Studju randomised komparattiv fil- fażi III, fejn id- doża użata kienet dik irrakkomandata, wera li Fasturtec, meta mqabbel ma ’ allopurinol, kellu azzjoni sinifikament aktar qawwija u bikrija.
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%).
Wara 4 sigħat mit- teħid ta ’ l- ewwel doża, kien hemm differenza sinifikanti fil- medja perċentwali tal- bidla minn dik bażika, fil- livell ta ’ l- aċidu uriku fil- plażma (p < 0. 0001), fil- grupp li ħa Fasturtec (- 86. 0%), meta mqabbel ma ’ dak il- grupp li ħa allopurinol (- 12. 1%).
Time to first confirmation of normal levels of uric acid in hyperuricaemic patients is four hours for Fasturtec and 24 hours for allopurinol.
Il- ħin li jrid jgħaddi, biex il- livelli ta ’ l- aċidu uriku jinżlu għan- normal, f’ dawk il- pazjenti li għandhom livelli għoljin fid- demm, huwa ta ’ erba ’ sigħat b’ Fasturtec u 24 sigħa b’ allopurinol.
In addition this rapid control of uric acid in this population is accompanied by improvements in renal function.
Addizzjonalment, dan il- kontroll ta ’ malajr fil- livell ta ’ l- aċidu uriku, f’ dan il- grupp, huwa akkompanjat ma ’ titjib fil - funzjoni renali.
In turn, this allows efficient excretion of the serum phosphate load preventing further deterioration of renal function from calcium/ phosphorus precipitation.
Bħala konsegwenza, dan jirriżulta f’ eskrezzjoni effiċjenti mill- ġisem taż- żieda fil - fosfat tas- serum, li jwassal għall- prevenzjoni ta ’ aktar tnaqqis fil- funzjoni renali, mid- depożitu tal - kalċju/ fosfru.
Paediatric patients In pivotal clinical studies, 246 patients (< 18 years) 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).
Pazjenti pedjatriċi Fi studji kliniċi pivitali, 246 pazjent (< 18- il sena) 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).
Efficacy results on 229 evaluable patients showed an overall response rate (normalization of plasma uric acid levels) of 96.1%.
Riżultati fuq l - effikaċja ‘ 229 pazjent li setgħu jiġu evalwati, urew rata ta ’ rispons totali (normalizzazzjoni tal- livelli ta ’ l- aċidu uriku fil- plażma) ta ’ 96. 1%.
Safety results on 246 patients were consistent with the adverse events profile in the overall population.
Ir- riżultati tas- sigurta ’ fuq 246 pazjent kienu konsistenti mal - profil tar- reazzjonijiet avversi fil- popolazzjoni totali.
In long term safety studies, an analysis of data from 867 patients (< 18 years) treated with rasburicase at 0.20 mg/ kg/ day for 1 to 24 days (mainly 1 to 4 days) showed consistent findings with pivotal clinical studies in terms of efficacy and safety.
Fi studji tas- sigurta ’ fuq tul taż- żmien, analiżi tad- data minn 867 pazjent (< 18- il sena) trattati bi rasburicase f’ doża ta ’ 0. 20 mg/ kg/ jum minn 1 sa 24 jum (prinċipalment 1 sa 4 ijiem) uriet konsistenza mar- riżultati ta’ studji kliniċi pivitali fuq- sigurta ’ u effikaċja.
After infusion of rasburicase at a dose of 0.20 mg/ kg/ day, steady state is achieved at day 2 - 3.
Wara l- infużjoni ta ’ rasburicase f’ doża ta ’ 0. 20 mg/ kg/ jum, il- konċentrazzjoni fissa tintlaħaq fit- tieni jew fit- tielet jum.
No unexpected accumulation of rasburicase was observed.
Ma kienx hemm akkumulazzjoni mhix mistennija ta ’ rasburicase.
In patients, the volume of distribution ranged from 110 - 127 ml/ kg, which is comparable to the physiological vascular volume.
Fil- pazjenti, l - volum ta ’ ditribuzzjoni tal- prodott kien minn 110 - 127 ml/ kg, li huwa komparabbli mal- volum vaskulari fisjoloġiku.
19 hours.
It- tneħħija ta ’ rasburicase kienet ta ’ madwar 3. 5 ml / siegħa/ kg u l- half- life ta ’ eliminzzjoni madwar 19- il siegħa.
The patients included in the pharmacokinetic studies were mainly children and adolescents.
Il- pazjenti mdaħħla fl- istudji farmakokinetiċi kienu prinċipalment tfal u adolexxenti.
35%) in children and adolescents compared to adults, resulting in a lower systemic exposure.
Minn din id- data limitata, jidher li t- tneħijja tal- prodott hija aktar mgħaġġla (madwar 35%) fit- tfal u l- adoloxxenti, meta mqabbla ma ’ l- adulti, bil- konsegwenza li hemm anqas espożizzjoni sistemika.
Rasburicase is a protein, and therefore:
Rasburicase hija proteina u, għalhekk:
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.
1) mhix mistennija li taqbad mal- proteini, 2) hija mistennija li d- degradazzjoni metabolika issegwi fil- linja ta ’ proteini oħra, i. e. idrolisi tal- peptide 3) u mhux probabbli li tkun involuta f’ interazzjonijiet ma ’ sustanzi mediċinali oħra.
Renal elimination of rasburicase is considered to be a minor pathway for rasburicase clearance.
L- eliminazzjoni renali ta ’ rasburicase hija meqjusa bħala mezz minuri fit- tneħħija ta ’ rasburicase mill - ġisem.
As metabolism is expected to occur by peptide hydrolysis, an impaired liver function is not expected to affect the pharmacokinetics.
Peress li l- metaboliżmu huwa mistenni li jsir permess ta ’ l- idrolisi tal- peptide, indeboliment fil - funzjoni tal- fwied mhux mistenni li jaffetwa l- komportament farmakokinetiku.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Informazzjoni mhux klinika, magħmula fuq studji konvenzjonali ta sigurtà farmakoloġika, effett tossiku minn dożi ripetuti u effett tossiku fuq il- ġeni, uriet li m’ hemmx riskju speċjali fil- bniedem.
The interpretation of the non-clinical studies is hampered due to the presence of endogenous urate oxidase in standard animal models.
L - interpretazzjoni ta ’ l- istudji mhux kliniċi hija mxekkla mill- preżenza ta ’ l- enzima urate oxidase li tinsab fil- ġisem b’ mod naturali, f’ sistema standardiżżata fl- annimali.
Powder: alanine mannitol disodium phosphate dodecahydrate disodium phosphate dihydrate sodium dihydrogen phosphate dihydrate
Trab: alanine mannitol disodium phosphate dodecahydrate disodium phosphate dihydrate sodium dihydrogen phosphate dihydrate
Solvent: poloxamer 188 water for injection
Solvent: poloxamer 188 ilma għall- injezzjoni
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti medicinali oħrajn ħlief dawk imsemmija f’ sezzjoni 6. 6.
Rasburicase solution should be infused through a different line than that used for infusion of chemotherapeutic agents to prevent any possible drug incompatibility.
Is- soluzzjoni ta ’ rasburicase trid tingħata permezz ta ’ infużjoni minn kateter għal ġol- vini, separat minn dak użat ghall- infużjoni tas- sustanzi mediċinali kimoterapewtiċi, biex tkun eliminata kull possibbiltà ta ’ inkompatibilità ma ’ mediċini oħra.
If use of a separate line is not possible, the line should be flushed out with saline solution between chemotherapeutic agent infusions and rasburicase.
Jekk l- użu ta ’ pajp separat mhux possibbli, il- kateter għal ġol- vini irid jiġi ifflaxjat b’ soluzzjoni ta ’ salina bejn l- infużjoni tas- sustanza kimoterapewtika u dik ta ’ rasburicase.
No filter should be used for infusion.
M’ ghandux jintuża filtru għall- infużjoni.
Do not use any glucose solution for dilution due to potential incompatibility.
M’ għandhiex tintuża soluzzjoni tal- glukosju biex tiddilwi, dovut għal inkompatibilità potenzjali.
After reconstitution or dilution an immediate use is recommended.
Wara li jkun rikostitwit jew dilwit, l- użu immedjat huwa rrakkomandat.
However, the in-use stability has been demonstrated for 24 hours between +2 °C and 8 °C.
Madankollu, l- istabbilità tal - prodott fl- użu ntwera ghal 24 siegħa bejn +2 °Ċ u +8 °Ċ.
Powder in vial: store in a refrigerator (2 °C - 8 °C).
Trab fil- kunjett: aħżen fi friġġ (2 °Ċ – 8 °Ċ).
For storage conditions of the reconstituted or the diluted medicinal product, see section 6.3.
Għall- kundizzjonijiet ta ’ ħazna tal- prodott mediċinali rikostitwit jew dilwit, ara sezzjoni 6. 3.
Fasturtec is supplied as a pack of:
Fasturtec huwa ipprovdut f’ pakkett ta ’:
3 vials of 1.5 mg rasburicase and 3 ampoules of 1 ml solvent.
3 kunjetti ta ’ 1. 5 mg rasburicase u 3 ampulli ta ’ 1 ml ta ’ solvent.
The powder is supplied in 3 ml clear glass (type I) vial with a rubber stopper and the solvent in a 2 ml clear glass (type I) ampoule.
It- trab huwa fornut f’ kunjett ta ’ 3 ml, ta ’ ħġieġ ċar (tip I), b’ tapp tal- lasktu, u s- solvent f’ ampulla ta ’ 2 ml, ta ’ ħġieġ car (tip I).
1 vial of 7.5 mg rasburicase and 1 ampoule of 5 ml solvent.
Kunjett 1 ta ’ 7. 5 mg rasburicase u ampulla 1 ta ’ 5 ml solvent.
The powder is supplied in 10 ml clear glass (type I) vial with a rubber stopper and the solvent in a 5 ml clear glass (type I) ampoule.
It- trab huwa fornut f’ kunjett ta ’ 10 ml, ta ’ ħġieġ ċar (tip I), b’ tapp tal- lasktu, u s- solvent f’ ampulla ta ’ 5 ml, ta ’ ħġieġ ċar (tip I).
6 6.6 Special precautions for disposal and other handling
Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor 6. 6
Rasburicase must be reconstituted with the entire volume of the supplied solvent ampoule (1.5 mg rasburicase vial to be reconstituted with the 1 ml solvent ampoule; 7.5 mg rasburicase vial to be reconstituted with the 5 ml solvent ampoule).
Rasburicase għandu jiġi rikostitwit bil- volum sħiħ tas- solvent fl- ampulla ipprovduta (kunjett ta ’ 1. 5 mg rasburicase jiġi rikostitwit b’ ampulla ta ’ 1 ml solvent; kunjett ta ’ 7. 5 mg rasburicase jiġi rikostitwit b’ ampulla ta ’ 5 ml solvent).
Reconstitution results in a solution with a concentration of 1.5 mg/ ml rasburicase to be further diluted with sodium chloride 9 mg/ ml (0.9%) intravenous solution.
Ir- rikostituzzjoni tirriżulta f’ soluzzjoni ta ’ 1. 5 mg/ ml rasburicase, li għandha tiġi dilwita aktar b ’ soluzzjoni għal ġol- vini ta ’ sodium chloride 9 mg/ ml (0. 9%).
Reconstitution of the solution:
Rikostituzzjoni tas- soluzzjoni:
Add the content of one ampoule of solvent to one vial containing rasburicase and mix by swirling very gently under controlled and validated aseptic conditions.
Żid il- kontenut ta ’ ampulla waħda ta ’ solvent ma ’ kunjett wiehed li fih rasburicase u ħawwad billi iddawwar il- kontenut tal- kontenitur bil- mod, taħt kondizzjonijiet asettiċi kkontrollati u validati.
Do not shake.
Iċċaqlaqx ’ l fuq u ’ l isfel.
Inspect visually prior to use.
Eżamina viżwalment qabel l- użu.
Only clear and colourless solutions without particles should be used.
Dawk biss li jkollhom soluzzjoni ċara u bla kulur, mingħajr frak, għandħom jintużaw.
For single-use only, any unused solution should be discarded.
Jintuża darba biss; kull soluzzjoni li ma tintużax għandha tintrema.
The solvent contains no preservative.
Is- solvent ma fih ebda preservattiv.
Therefore the reconstituted solution should be diluted under controlled and validated aseptic conditions.
Għalhekk, is- soluzzjoni rikostitwita trid tiġi dilwita taħt kondizzjonijiet asettiċi kkontrollati u validati.
Dilution before infusion:
Is- sustanza dilwita qabel l- infużjoni:
The required volume of the reconstituted solution depends on the patient's body weight.
Il- volum meħtieġ tas- soluzzjoni rikostitwita jiddependi mill- piż tal- ġisem tal- pazjent.
The use of several vials may be necessary to obtain the quantity of rasburicase required for one administration.
L- użu ta ’ diversi kunjetti jista ’ jkun neċessarju biex tikseb il- kwantità ta ’ rasburicase meħtieġa għall- għotja waħda.
The required volume of the reconstituted solution, taken from one or more vials, is to be further diluted with sodium chloride 9 mg/ ml (0.9%) solution to make a total volume of 50 ml.
Il - volum meħtieġ tas- soluzzjoni rikostitwita, meħud minn kunjett wieħed jew aktar, għandu jiġi dilwit iżjed b’ soluzzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%), biex b’ hekk tilħaq il- volum totali ta ’ 50 ml.
The concentration of rasburicase in the final solution for infusion depends on the patient's body weight.
Il - konċentrazzjoni ta ’ rasburicase fis- soluzzjoni finali għall- infużjoni tiddependi fuq il- piz tal- ġisem tal - pazjent.
The reconstituted solution contains no preservative.
Is- soluzzjoni rikostitwita m’ għandha ebda preservattiv.
Therefore the diluted solution should be infused immediately.
Għalhekk, is- soluzzjoni dilwita trid tingħata permezz ta ’ infużjoni mmedjatament.
Infusion:
7 L- infużjoni:
The final solution should be infused over 30 minutes.
Is- soluzzjoni finali trid tingħata permezz ta ’ infużjoni fuq perijodu ta ’ 30 minuta.
Sample handling:
L- immaniġġar tal- kampjun:
If it is necessary to monitor a patient’ s uric acid level, a strict sample-handling procedure must be followed to minimise ex vivo degradation of the analyte.
Jekk huwa meħtieġ li l- livell ta l- aċidu uriku tal- pazjent ikun immoniterjat, trid tittieħed proċedura stretta fl- immaniġġar tal- kampjun, biex titnaqqas għall- aħħar id- degradazzjoni ex vivo tal- kampjun.
Blood must be collected into pre-chilled tubes containing heparin anticoagulant.
Id - demm għandu jitpoġġa f’ tubi, li fihom heparin bħala sustanza kontra l- koagulazzjoni tad- demm, u li dawn iridu jkunu imkesħin qabel ma ’ tibda l- proċedura.
Samples must be immersed in an ice/ water bath.
Il- kampjuni għandhom jitpoġġew f’ banju tal - laboratorju taħt is - silġ/ ilma.
Plasma samples should immediately be prepared by centrifugation in a pre-cooled centrifuge (4 °C).
Il- kampjuni tal- plażma għandhom jiġu ippreparati immedjatament permezz taċ- ċentrifugazzjoni, f’ apparat li jkun imkessaħ minn qabel (4 °C).
Finally, plasma must be maintained in an ice/ water bath and analysed for uric acid within 4 hours.
Finalment, il- plażma għandha tinżamm fil- banju mimli silġ/ ilma u l- analiżi għall- aċidu uriku trid issir fi żmien 4 sighat.
MARKETING AUTHORISATION HOLDER
ID- DETENUR TA ’ L- AWTORIZZAZZJONI GHAT- TQEGĦID FIS- SUQ
sanofi-aventis 174, avenue de France F - 75013 Paris France
sanofi- aventis 174, avenue de France F - 75013 Paris Franza
23 February 2001 Date of latest renewal:
23 ta ’ Frar, 2001 Data ta ’ l- aħħar tiġdid:
23 February 2006
23 ta ’ Frar, 2006
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
Sanofi Chimie Route d’ Avignon 30390 Aramon France
Sanofi Chimie Route d’ Avignon 30390 Aramon Franza
Glaxo Wellcome Production 1, rue de l’ Abbaye 76960 Notre Dame de Bondeville France
Glaxo Wellcome Production 1, rue de l’ Abbaye 76960 Notre Dame de Bondeville Franza
Località Valcanello 03012 Anagni (FR) Italy
Località Valcanello 03012 Anagni (FR) L- Italja
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta ’ tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli għall- ħruġ tal- lott konċernat
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DENTENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
PACK OF 3 POWDER VIALS and 3 SOLVENT AMPOULES
PAKKETT TA ’ 3 KUNJETTI BIT- TRAB u 3 AMPULLI BIS- SOLVENT
Fasturtec 1.5 mg/ ml powder and solvent for concentrate for solution for infusion
Fasturtec 1. 5 mg/ ml trab u solvent għall- konċentrat għal soluzzjoni għall- infużjoni
rasburicase 1.5 mg/ 1 ml
rasburicase 1. 5 mg/ 1 ml
rasburicase produced by genetechnology in Saccharomyces cerevisiae strain
rasburicase magħmul b’ teknoloġija ġenetika f’ razza ta ’ Saccharomyces cerevisiae
Powder also contains: alanine, mannitol, disodium phosphate dodecahydrate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.
It- trab fih ukoll: alanine, mannitol, disodium phosphate dodecahydrate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.
Solvent: poloxamer 188, water for injection.
Solvent: poloxamer 188, ilma għall- injezzjoni.
Powder and solvent for concentrate for solution for infusion
Trab u solvent għall- konċentrat għal soluzzjoni għall- infużjoni
3 vials and 3 ampoules
3 kunjetti u 3 ampulli
1.5 mg/ 1 ml
1. 5 mg/ 1 ml
METHODS AND ROUTE(S) OF ADMINISTRATION
MOD TA ’ KIF U MNEJN JINGĦATA
Reconstitution required with the entire contents of the 1 ml solvent ampoule
Ir- rikostituzzjoni meħtieġa bil- kontenut sħiħ ta ’ ampulla b’ 1 ml solvent
EXP Use immediately after reconstitution or dilution
Uża immedjatament wara r- rikostittuzzjoni jew meta jiġi dilwit.
9 SPECIAL STORAGE CONDITIONS
9 KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN
Do not freeze
Tagħmlux fil- friża
Store in the original package in order to protect from light
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TAL- PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
14 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PACK OF 3 POWDER VIALS AND 3 SOLVENT AMPOULES
PAKKETT TA ’ 3 KUNJETTI BIT- TRAB U 3 AMPULLI BIS- SOLVENT
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
15 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻAGĦAR EWLENIN
POWDER/ VIAL
TRAB/ KUNJETT
Fasturtec 1.5 mg/ ml powder for concentrate for solution for infusion rasburicase Intravenous use
Fasturtec 1. 5 mg/ ml trab għall- konċentrat għal soluzzjoni għall- infużjoni
SOLVENT/ AMPOULE
SOLVENT/ AMPULLA
Solvent for rasburicase 1.5 mg
Solvent għal rasburicase 1. 5 mg
PACK OF 1 POWDER VIAL and 1 SOLVENT AMPOULE
PAKKETT TA ’ KUNJETT 1 BIT- TRAB u AMPULLA 1 BIS- SOLVENT
rasburicase 7.5 mg/ 5 ml
rasburicase 7. 5 mg/ 5 ml
Powder also contains: alanine, mannitol, disodium phosphate dodecahydrate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate
It- trab fih ukoll: alanine, mannitol, disodium phosphate dodecahydrate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.
Solvent: poloxamer 188, water for injection
Solvent: poloxamer 188, ilma għall- injezzjoni.
Powder and solvent for concentrate for solution for infusion 1 vial and 1 ampoule
Trab u solvent għall- konċentrat għal soluzzjoni għall- infużjoni
Reconstitution required with the entire contents of the 5 ml solvent ampoule
Ir- rikostituzzjoni meħtieġa bil- kontenut sħiħ ta ’ ampulla b’ 5 ml solvent
sanofi-aventis 174, avenue de France F - 75013 Paris France
sanofi- aventis 174, Avenue de France F - 75013 Paris Franza
19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
19 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻAGĦAR EWLENIN
20 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
20 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Solvent for rasburicase 7.5 mg
Solvent għal rasburicase 7. 5 mg
Fasturtec 1.5 mg/ ml powder and solvent for concentrate for solution for infusion rasburicase
Fasturtec 1. 5 mg/ ml trab u solvent għall- konċentrat għal soluzzjoni għall- infużjoni rasburicase
- If you have any further questions, ask your doctor, nurse or hospital pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib, l- infermier jew l- ispiżjar ta ’ l- isptar tiegħek.
please tell your doctor, nurse or hospital pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib,, l- infermier jew l- ispiżjar ta ’ l- isptar tiegħek.
What Fasturtec is and what it is used for 2.
X’ inhu Fasturtec u għalxiex jintuża 2.
Before you use Fasturtec 3.
Qabel ma tuża Fasturtec 3.
How to use Fasturtec 4.
Kif għandek tuża Fasturtec 4.
How to store Fasturtec 6.
Kif taħżen Fasturtec 6.
WHAT FASTURTEC IS AND WHAT IT IS USED FOR
X’ INHU FASTURTEC U GĦALXIEX JINTUŻA
Fasturtec contains the active ingredient rasburicase.
Fasturtec huwa magħmul mil - ingredjent attiv, rasburicase.
Rasburicase is used to treat or prevent high blood levels of uric acid from occurring in patients with disorders of the blood cells (haematological diseases) who are about to receive or are receiving chemotherapy treatment.
Rasburicase jintuża biex jittratta jew jimpedixxi livelli għolja ta ’ l- aċidu uriku fid- demm f’ pazjenti li għandhom disturbi fiċ- ċelluli tad- demm (mard ematoloġiċi) li ser jirċievu jew qegħdin jirċievu t - trattament tal- kimoterapija.
When chemotherapy is given, cancer cells are destroyed, releasing large amounts of uric acid into the bloodstream.
Meta jingħata l- kimoterapija, iċ- ċelloli tal- kanċer jiġu meqruda u ammont kbir ta ’ l- aċidu uriku joħroġ fiċ- cirkolazzjoni tad- demm.
Fasturtec works by allowing uric acid to more easily be removed from the body by the kidneys.
Fasturtec jaħdem billi jħalli l- aċidu uriku jitneħħa faċilment mil- ġisem permezz tal- kliewi.
BEFORE YOU USE FASTURTEC
QABEL MA TUŻA FASTURTEC
Do not use Fasturtec if you:
Tużax Fasturtec jekk:
- are allergic (hypersensitive) to rasburicase, other uricases or any of the other ingredients of
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal rasburicase, uricases oħra jew sustanżi
Fasturtec
oħra ta ’ Fasturtec
- have a history of haemolytic anaemia (an illness caused by red blood cells being abnormally
- għandek storja medika ta ’ anemija emolitika (marda kkawżata minn ċelluli tad- demm li jkunu
broken down).
mkissrin b’ mod anormali)
Take special care with Fasturtec if you:
Oqgħod attent ħafna b’ Fasturtec jekk int:
- have a history of any kind of allergy.
- għandek storja ta ’ l- allerġija.
Tell your doctor if you have ever had any allergic type reactions due to other medicines as Fasturtec can cause allergic-type reactions, including severe cases.
Għid lit- tabib tiegħek jekk kellek xi tip ta ’ reazzjonijiet allerġiċi minħabba xi mediċini oħra peress li Fasturtec jista ’ jikkawża tipi ta ’ reazzjonijiet allerġiċi inklużi allergiċi severi..
It is not known whether the chance of developing an allergic reaction is increased if treatment with Fasturtec is repeated.
Mhux magħruf jekk iċ- ċans li tiżviluppa reazzjoni allerġika tiżdiedx jekk it- trattament bil Fasturtec jerġa jiġi ripetut.
In case of disorders of the blood in which red blood cells are abnormally broken down (haemolysis) or abnormal blood pigment levels (methaemoglobinaemia), your doctor will immediately and permanently discontinue treatment with Fasturtec.
Fil- kas ta ’ disturbi fid- demm fejn iċ- ċelluli ħomor tad- demm ikunu mkissrin b’ mod anormali (emolisi) jew livelli anormali tal- pigment tad- demm (metemoglobinemija), it- tabib tiegħek għandu jwaqqaf it - trattament bil- Fasturtec immedjatament u b’ mod permanenti.
23 medicines obtained without a prescription.
23 Meta tuża mediċini oħra Jekk jogħġbok, għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Pregnancy and breast feeding Tell your doctor if you are, or think you may be pregnant, or if you are breast-feeding.
Tqala u treddigħ Għid lit- tabib tiegħek jekk inti tqila jew qed tippjana biex toħroġ tqila jew jekk qed tredda.
Driving and using machines No information on the ability to drive and use machines is available.
Sewqan u tħaddim ta ’ magni M’ hemmx informazzjoni disponibbli dwar l- effetti fuq il- ħila fis- sewqan u t- tħaddim ta ’ magni.
HOW TO USE FASTURTEC
KIF GĦANDEK TUŻA FASTURTEC
Fasturtec is to be given to you before or during the start of your course of chemotherapy.
Fasturtec għandu jingħata lilek qabel u fil- bidu tal- kors tiegħek tal- kimoterapija.
Fasturtec is injected slowly into a vein, which should take about 30 minutes.
Fasturtec huwa injettat bil- mod ġol- vina, f’ ħin ta ’ madwar 30 minuta.
Your dose will be calculated according to your body weight.
Id- doża tiegħek sejra tkun ikkalkulata skond il- piż ta ’ ġismek.
The recommended dose is 0.20 mg per kg of body weight per day in both children and adults.
Id- doża rrakkomandata hija 0. 20 mg għal kull kg tal- piż tal- ġisem kuljum fit- tfal u fl- adulti.
It will be given once a day, for up to 7 days.
Ser tingħata darba kuljum, sa 7 ijiem.
During treatment with Fasturtec, your doctor will carry out blood tests to check the levels of uric acid and decide how long you will be treated for.
Matul it- trattament bil Fasturtec, it- tabib tiegħek iwettaq testijiet tad- demm biex jiċċekkja l- livelli tal- aċidu uriku u jiddeċidi kemm ser iddum tiġi ttrattata.
Your doctor may also test your blood to make sure that you do not develop any blood disorders.
It- tabib tiegħek jista ’ jittestja id- demm tiegħek biex jiżgura li inti ma tiżviluppax xi disturbi fid- demm.
If you use more Fasturtec than you should If it does occur, the doctor will closely monitor the effects on your red blood cells and treat any symptoms that follow.
Jekk tuża Fasturtec akatar milli suppost Jekk jiġri hekk, it- tabib jimmoniterja bir- reqqa l- effetti fuq iċ- ċelluli ħomor tad- demm tiegħek u jittratta xi simptomi li jistgħu jinqalgħu.
If you have any further questions on the use of this product, ask your doctor, nurse or hospital pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib, l- infermier jew l- ispiżjar ta ’ l- isptar tiegħek.
Like all medicines, Fasturtec can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Fasturtec jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Fasturtec will be administered at the same time as other medicines that may also cause side effects.
Fasturtec ser jingħata flimkiem bħal mediċini oħra li jista jkollhom effetti sekondarji.
If you suddenly notice:
Jekk tinnota f’ daqqa waħda:
- a swelling of the face, lips, tongue or other part of your body
- nefħa fil- wiċċ, fix- xufftejn, fl- ilsien jew xi parti oħra ta ’ ġismek
- a shortness of breath, wheezing or breathing problems
- qtugħ ta ’ nifs, tħarħir, jew problemi fin- nifs
- a rash, itching or hives
- raxx, ħakk jew urtikarja
tell your doctor, nurse or hospital pharmacist immediately as these may be signs of a serious allergic reaction (anaphylaxis).
Għid lit- tabib, l- infermier jew l- ispiżjar ta ’ l- isptar immedjatament għax jistgħu jkunu sinjali ta ’ reazzjoni allerġika serja (anafilassi).
These are rare (affecting between 1 in 1,000 and 1 in 10,000 patients).
Dawn huma rari (jaffetwaw bejn 1 minn kull 1, 000 u 1 minn kull 10, 000 pazjent).
Common side effects (affecting between 1 in 10 and 1 in 100 patients):
Effetti sekondarji komuni (jaffetwaw bejn 1 minn kull 10 u 1 minn kull 100 pazjent):
- high fever
- deni għoli
- allergic reactions, mainly rashes and urticaria.
- reazzjonijiet allerġiċi, fil- biċċa kbira raxxijiet u urtikarja.
Uncommon side effects (affecting between 1 in 100 and 1 in 1,000 patients):
Effett sekondarju mhux komuni (jaffetwaw bejn 1 minn kull 100 u 1 minn kull 1, 000 pazjent):
- severe allergic reaction, such as low blood pressure (hypotension) and wheezing or difficulty in
- reazzjoni allerġika, bħal pressjoni baxxa tad- demm (pressjoni baxxa ħafna) u tħarħir jew qtugħ
breathing (bronchospasm)
ta ’ nifs (spasmu tal- bronki)
- severe diarrhoea
- dijarea severa
- severe vomiting
- rimettar sever
- severe nausea
- tqalligħ sever
- severe headache
- uġigħ ta ’ ras sever
- blood disorders such as a disorder of the blood in which red blood cells are abnormally broken
- disturbi fid- demm bħal disturbi fid- demm fejn iċ- ċelluli ħomor tad- demm ikunu mkissrin b’ mod
down (haemolysis) or abnormal blood pigment levels (methaemoglobinaemia).
anormali (emolisi) jew livelli anormali tal- pigment tad- demm (metemoglobinemija).
24 Rare (affecting between 1 in 1,000 and 1 in 10,000 patients):
Effetti sekondarji rari (jaffetwaw bejn 1 minn kull 1, 000 u 1 minn kull 10, 000 pazjent):
- runny or blocked nose, sneezing, facial pressure or pain (rhinitis).
- imnieħer ibblokkat u li jħammeġ, għatis, pressjoni jew uġigħ fil- wiċċ (infjammazzjoni tal -
If you notice any of these, tell your doctor, nurse or hospital pharmacist.
Jekk tinnota xi waħda minn dawn l- effetti sekondarji, għid lit- tabib, l- infermier jew l- ispiżjar ta ’ l - isptar tiegħek.