FrancophonIA/ELRC3.0 huggingface dataset:
English: Most hypersensitivity reactions to asparaginase are observed during subsequent treatment phases (reinduction treatment, delayed intensification).
Croatian: Većina reakcija preosjetljivosti na asparaginazu opažene su tijekom kasnijih faza liječenja (reindukcijsko liječenje, odgođena intenzifikacija).
English: Non-clinical repeat-dose toxicity and safety pharmacology studies in rats revealed no special hazard for humans, except a slight but significant saluretic effect at doses below the recommended dose for ALL/LBL patients.
Croatian: Neklinička ispitivanja toksičnosti ponovljenih doza i sigurnosne farmakologije provedena u štakora, nisu ukazala na poseban rizik za ljude osim neznatnog ali značajnog saluretičkog učinka opaženog kod doza ispod preporučene doze za bolesnike s ALL/LBL-om.
English: No reproduction studies in animals with asparaginase were performed but studies with asparaginase preparations in mice, rats, chicken and rabbits have shown embryotoxic and teratogenic effects (see section 5.3).
Croatian: Nisu provedena ispitivanja učinka asparaginaze na reprodukciju u životinja, ali ispitivanja s pripravcima asparaginaze u miševa, štakora, pilića i kunića pokazala su embriotoksične i teratogene učinke (vidjeti dio 5.3).
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon rekonstitucije i razrjeđivanja lijeka vidjeti dijelu 6.3.
English: Asparaginase does not seem to penetrate the blood-brain barrier in measurable amounts.
Croatian: Čini se da asparaginaza ne prolazi krvno-moždanu barijeru u mjerljivim količinama.
English: Name and address of the manufacturer of the biological active substance Wacker Biotech GmbH
Croatian: Naziv i adresa proizvođača biološke djelatne tvari Wacker Biotech GmbH
English: However, when asparaginase was given after cytarabine a synergistic effect was observed.
Croatian: Međutim, kada se asparaginaza daje poslije citarabina, opažen je sinergistički učinak.
English: Elderly Limited data are available for the treatment of patients older than 65 years of age.
Croatian: Podaci o liječenju bolesnika starijih od 65 godina su ograničeni.
English: Spectrila is used to treat adults and children with acute lymphoblastic leukaemia (ALL) which is a form of blood cancer.
Croatian: Spectrila se primjenjuje za liječenje odraslih i djece s akutnom limfoblastičnom leukemijom (ALL), što je posebna vrsta raka krvi.
English: It is unclear whether the RPLS is caused by asparaginase, concomitant treatment or the underlying diseases.
Croatian: Nije jasno je li RPLS prouzročen asparaginazom, istovremenim liječenjem ili osnovnom bolešću.
English: In the majority of cases, your treatment can be continued by switching to other medicines containing different forms of asparaginase.
Croatian: U većini slučajeva, liječenje se može nastaviti prelaskom na druge lijekove koji sadrže različite oblike asparaginaze.
English: The dose depends on your body surface area (BSA) which is calculated from your height and weight.
Croatian: Doza ovisi o Vašoj tjelesnoj površini, što se izračunava na temelju
English: Because of a higher frequency of comorbidities such as liver and/or renal impairment, patients > 55 years of age usually tolerate asparaginase treatment worse than paediatric patients.
Croatian: Zbog veće učestalosti komorbiditeta kao što su oštećenje funkcije jetre i/ili bubrega, bolesnici stariji od 55 godina obično podnose liječenje asparaginazom lošije nego pedijatrijski bolesnici.
English: In addition to asparagine, asparaginase is also able to cleave the amino acid glutamine to glutamic acid and ammonia, however with much less efficiency.
Croatian: Osim asparagina, asparaginaza također može cijepati aminokiselinu glutamin na glutamatnu kiselinu i amonijak, ali mnogo manje učinkovito.
English: Absorption Asparaginase is not absorbed by the gastrointestinal tract, thus Spectrila must be given intravenously.
Croatian: Asparaginaza se ne apsorbira putem gastrointestinalnog sustava, dakle, Spectrila se mora primjenjivati intravenski.
English: These antibodies may induce clinical allergic reactions, inactivate the enzymatic activity or accelerate the elimination of asparaginase.
Croatian: Ta protutijela mogu izazvati kliničke alergijske reakcije, deaktivirati enzimatsku aktivnost ili ubrzati eliminaciju asparaginaze.
English: If you are sexually mature you must use contraceptives or remain abstinent during chemotherapy and for up to 3 months after the end of treatment.
Croatian: Ako ste spolno zreli, morate primjenjivati kontracepciju ili se sustezati od spolnih odnosa za vrijeme kemoterapije te do 3 mjeseca nakon završetka liječenja.
English: Do not use this medicine after the expiry date which is stated on the carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji.
English: Therefore, vincristine should be given 3 to 24 hours before administration of asparaginase in order to minimise toxicity.
Croatian: Stoga vinkristin treba dati od 3 do 24 sata prije primjene asparaginaze, kako bi se smanjila toksičnost.
English: Spectrila is given into a vein.
Croatian: Spectrila se daje u venu.
English: Asparaginase may also be toxic to normal cells that divide rapidly and are dependent to some degree on exogenous asparagine supply.
Croatian: Asparaginaza može biti toksična i za normalne stanice koje se brzo dijele i u određenom stupnju ovise o nekom vanjskom izvoru asparagina.
English: Spectrila should not be used during pregnancy unless the clinical condition of the woman requires treatment with asparaginase.
Croatian: Spectrila se ne smije primjenjivati u trudnoći osim ako kliničko stanje žene zahtijeva liječenje asparaginazom.
English: However, in rare cases severe hypertriglyceridaemia (triglycerides > 1,000 mg/dl) has been reported which increases the risk of development of acute pancreatitis.
Croatian: Međutim, u rijetkim slučajevima zabilježena je teška hipertrigliceridemija (trigliceridi > 1000 mg/dl) što povećava rizik od razvoja akutnog pankreatitisa.
English: A list of all other side effects is set out below according to how common they are: Very common side effects (may affect more than 1 in 10 people):
Croatian: Popis drugih nuspojava naveden je u nastavku, prema njihovoj učestalosti: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba):
English: Preferably, levels should be measured three days after the last asparaginase administration, i.e. usually directly before the next dose of asparaginase is given.
Croatian: Poželjno je razine aktivnosti mjeriti tri dana nakon zadnje primjene asparaginaze, tj. obično neposredno prije davanja sljedeće doze asparaginaze.
English: What Spectrila is and what it is used for What you need to know before you are given Spectrila How to use Spectrila
Croatian: Što je Spectrila i za što se koristi Što morate znati prije nego počnete primati Spectrilu Kako primjenjivati Spectrilu Moguće nuspojave
English: Since serum protein is important for the binding and transport function of some active substances, the serum protein level should be monitored regularly.
Croatian: Budući da je serumski protein važan za funkciju vezanja i prijenosa nekih djelatnih tvari, potrebno je redovito praćenje razine proteina u serumu.
English: In addition, treatment with asparaginase can result in disturbances in organ systems which exhibit a high level of protein synthesis.
Croatian: Osim toga, liječenje asparaginazom može rezultirati smetnjama u organskim sustavima koji pokazuju visoku razinu sinteze proteina.
English: Spectrila has moderate influence on the ability to drive and use machines, especially through its potential effects on the nervous and gastrointestinal systems (see section 4.8).
Croatian: Spectrila umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima, osobito preko mogućih učinaka na živčani i gastrointestinalni sustav (vidjeti dio 4.8).
English: However, in rare cases it can result in diabetic ketoacidosis.
Croatian: Međutim, u rijetkim slučajevima može rezultirati dijabetičkom ketoacidozom.
English: Based on results from animal studies and its mechanism of action, Spectrila should not be used during pregnancy unless the clinical condition of the woman requires treatment with asparaginase.
Croatian: Na temelju rezultata ispitivanja na životinjama i prema mehanizmu djelovanja, Spectrila se ne smije primjenjivati u trudnoći osim ako kliničko stanje žene zahtijeva liječenje asparaginazom.
English: Children 0 - 12 months old
Croatian: Djeca u dobi od 0 do 12 mjeseci
English: Therefore, caution should be exercised in patients receiving other medicines metabolised by the liver.
Croatian: Stoga je potreban oprez u bolesnika koji primaju druge lijekove koji se metaboliziraju putem jetre.
English: Spectrila should only be used by physicians who are experienced in such treatment protocols.
Croatian: Spectrilu smiju primjenjivati samo liječnici s iskustvom u takvim terapijskim protokolima.
English: • changes in the electroencephalogram (a trace of the electrical activity of your brain)
Croatian: • promjene u elektroencefalogramu (zapis električne aktivnosti mozga)
English: In very rare cases, severe hyperammonaemia has been reported which may induce neurologic disorders such as seizures and coma.
Croatian: U vrlo rijetkim slučajevima zabilježena je teška hiperamonijemija, što može potaknuti neurološke poremećaje kao što su napadaji i koma.
English: Asparaginase caused an increase in the incidence of malformations (including those of the central nervous system, heart and skeletal system) and foetal death at doses that are similar to or in excess of those proposed clinically (on a U/m² basis) in a number of species including the mouse, rat and/or rabbit.
Croatian: Asparaginaza je prouzročila povećanu incidenciju malformacija (uključujući one središnjeg živčanog sustava, srca i skeletnog sustava) te fetalnu smrt pri dozama koje su slične ili više od onih klinički predloženih (na temelju U/m²) u nekoliko vrsta uključujući miša, štakora i/ili kunića.
English: All cells need an amino acid called asparagine to stay alive.
Croatian: Svim je stanicama potrebna aminokiselina pod nazivom asparagin da bi preživjele.
English: The mean (Standard Deviation, SD) of the volume of distribution at steady state (Vdss) was 2.47 l (0.45 l).
Croatian: Prosječna vrijednost (standardna devijacija, SD) volumena distribucije u stanju dinamičke ravnoteže (Vdss) iznosila je 2,47 l (0,45 l).
English: Philadelphia chromosome-positive patients
Croatian: Bolesnici pozitivni na Philadelphia kromosom
English: Spectrila is usually employed as part of combination chemotherapy protocols with other antineoplastic agents (see also section 4.5).
Croatian: Spectrila se obično primjenjuje kao dio kemoterapijskih protokola kombiniranih s drugim antineoplastičnim lijekovima (vidjeti također dio 4.5).
English: If allergic symptoms occur, administration of asparaginase must be discontinued immediately and appropriate treatment given, which may include antihistamines and corticosteroids.
Croatian: Ako se pojave simptomi alergije, primjenu asparaginaze treba odmah prekinuti i uvesti odgovarajuće liječenje, što može uključiti antihistaminike i kortikosteroide.
English: In case of occurrence of allergic symptoms, administration of Spectrila should be discontinued immediately (see section 4.4).
Croatian: U slučaju pojave simptoma alergije, primjenu Spectrile treba odmah obustaviti (vidjeti dio 4.4).
English: Discontinuation or dose reduction of concomitantly administered immunosuppressive medicinal products may be necessary.
Croatian: Može biti potreban prekid ili smanjenje doze istodobno primjenjivanih imunosupresivnih lijekova.
English: The majority of anti-asparaginase antibodies developed in the time gap between the last asparaginase infusion on day 33 and start of post-induction treatment at day 79.
Croatian: Većina protutijela protiv asparaginaze razvila se u razmaku između posljednje infuzije asparaginaze 33. dana i početka postindukcijskog liječenja 79. dana.
English: Data on efficacy and safety of Spectrila in the post-induction treatment phases are very limited.
Croatian: Podaci o djelotvornosti i sigurnosti Spectrile u postindukcijskim fazama liječenja vrlo su ograničeni.
English: Immediately after the end of infusion of asparaginase, serum levels of glutamine declined by a maximum of 50 % from pre-dose levels of about 400 µM but rapidly returned to normal values within a few hours.
Croatian: Neposredno nakon završetka infuzije asparaginaze, serumske razine glutamina smanjile su se za najviše 50% u odnosu na razine prije doze od oko 400 µM, ali su se brzo vratile na normalne vrijednosti unutar nekoliko sati.
English: confusion, seizures and visual loss)
Croatian: smetenost, napadaji i gubitak vida)
English: These patients should no longer be treated with any asparaginase preparation.
Croatian: Ove se bolesnike dalje ne smije liječiti ni jednim pripravkom asparaginaze.
English: The toxicity of vincristine may be additive with that of asparaginase if both agents are administered concomitantly.
Croatian: Toksičnost vinkristina može biti aditivna toksičnosti asparaginaze ako se oba lijeka primjenjuju istovremeno.
English: • a serious allergic reaction which causes difficulty in breathing or dizziness,
Croatian: • ozbiljna alergijska reakcija koja uzrokuje otežano disanje ili omaglicu,
English: • nervousness (agitation) or somnolence (sleepiness)
Croatian: • nervoza (uznemirenost) ili somnolencija (pospanost)
English: Pharmacokinetic parameters of Spectrila were determined in 7 adult patients after intravenous infusion of 5,000 U/m².
Croatian: Farmakokinetički parametri Spectrile određeni su u 7 odraslih bolesnika nakon intravenske infuzije od 5000 U/m².
English: Concomitant treatment with myelosuppressive medicinal products and those known to cause infections are major contributing factors and patients should be carefully monitored for signs and symptoms of myelosuppression and infection (see section 4.8).
Croatian: Istovremeno liječenje mijelosupresivnim lijekovima i onima za koje je poznato da uzrokuju infekcije veliki su dodatni čimbenici pa je bolesnike potrebno pažljivo pratiti zbog znakova i simptoma mijelosupresije i infekcije (vidjeti dio 4.8).
English: Driving and using machines Do not drive when taking this medicine because it may make you feel drowsy, tired or confused.
Croatian: Nemojte voziti dok primate ovaj lijek jer on može djelovati tako da osjećate pospanost, umor ili smetenost.
English: • liver failure which may lead to death
Croatian: • zatajenje funkcije jetre što može dovesti do smrtnog ishoda
English: Based on limited data, the recommended dose in infants is as follows: - age less than 6 months:
Croatian: Na temelju ograničenih podataka, za dojenčad se preporučuje sljedeća doza: - dojenčad mlađa od 6 mjeseci:
English: Allergic reactions within 12 hours after asparaginase infusion during induction treatment Any allergic event* within 24 hours after asparaginase infusion during induction treatment
Croatian: Alergijske reakcije unutar 12 sati od infuzije asparaginaze tijekom indukcijskog liječenja Bilo koji alergijski događaj* unutar 24 sata od infuzije asparaginaze tijekom indukcijskog liječenja
English: Blood clotting disorders may require you to receive fresh plasma or a certain type of protein (antithrombin III) in order to reduce the risk of bleeding or formation of blood clots (thrombosis).
Croatian: Poremećaji zgrušavanja krvi mogu zahtijevati da primite svježu plazmu ili određene vrste proteina (antitrombin III) kako bi se smanjio rizik od krvarenja ili stvaranje krvnih ugrušaka (tromboza).
English: *Produced in Escherichia coli cells by recombinant DNA technology.
Croatian: * Proizvedeno u stanicama Escherichia coli tehnologijom rekombinantne DNK.
English: Asparaginase is produced by recombinant DNA technology in a microorganism named Escherichia coli.
Croatian: Asparaginaza je proizvedena tehnologijom rekombinantne DNK u mikroorganizmu naziva Escherichia coli.
English: Spectrila contains asparaginase, which is an enzyme that interferes with natural substances necessary for cancer cell growth.
Croatian: Spectrila sadrži asparaginazu, što je enzim koji utječe na prirodne tvari potrebne za rast stanica raka.
English: Common Depression, hallucination, confusion
Croatian: Često depresija, halucinacije, konfuzija
English: Ischaemic strokes are rare.
Croatian: Ishemijski moždani udari događaju se rijetko.
English: Concomitant treatment with corticosteroids contributes to this effect.
Croatian: Istovremeno liječenje kortikosteroidima pridonosi tom učinku.
English: Serum amylase and lipase are usually elevated, although in some patients they can be normal due to impaired protein synthesis.
Croatian: Serumske amilaza i lipaza obično su povišene, iako u nekih bolesnika te vrijednosti mogu biti normalne zbog narušene sinteze proteina.
English: Peak (Cmax) of asparaginase activity in serum was reached with a delay of approximately 2 hours after the end of the infusion.
Croatian: Vršna vrijednost (Cmax) aktivnosti asparaginaze u serumu bila je dosegnuta s odgodom od otprilike 2 sata nakon završetka infuzije.
English: This can promote tendency to bleeding (anticoagulants) or thrombosis (glucocorticoids).
Croatian: To može povećati sklonost krvarenju (antikoagulansi) ili trombozi (glukokortikoidi).
English: This antagonism is observed if asparaginase is administered prior to or concurrently with methotrexate.
Croatian: Taj antagonizam se opaža ako se asparaginaza primjenjuje prije ili istovremeno s metotreksatom.
English: These patients should no longer be treated with any asparaginase preparation (see also sections 4.3 and 4.8).
Croatian: Ove se bolesnike dalje ne smije liječiti ni jednim pripravkom asparaginaze (vidjeti također dijelove 4.3 i 4.8).
English: Increase in amylase, lipase, abnormal electroencephalogram (EEG) (reduced alpha wave activity, increased theta and delta wave activity)
Croatian: Često povećanje amilaze, lipaze, nepravilnosti elektroencefalograma (EEG) (smanjena aktivnost alfa valova, povećana aktivnost theta i delta valova)
English: The recommended dose in infants aged 0 - 12 months is as follows: - age less than 6 months:
Croatian: Preporučena doza u dojenčadi dobi od 0 do 12 mjeseci jest: - dojenčad mlađa od 6 mjeseci:
English: The mean asparagine concentrations in serum remained below 0.5 µM from immediately after the end of first infusion of asparaginase until at least three days after the last infusion.
Croatian: Prosječne koncentracije asparagina u serumu ostale su ispod 0,5 µM od trenutka neposredno nakon završetka prve infuzije asparaginaze do najmanje tri dana nakon posljednje infuzije.
English: • abnormal laboratory tests including changes in protein levels in the blood, changes in blood fat or in liver enzyme values or high level of urea in the blood
Croatian: • odstupanja laboratorijskih testova uključujući promjene razine proteina u krvi, promjene vrijednosti za masnoću u krvi ili vrijednosti enzima jetre ili visoke razine ureje u krvi
English: Conversely, the antitumour effects of methotrexate are enhanced when asparaginase is administered 24 hours following methotrexate treatment.
Croatian: Nasuprot tomu, protutumorski učinci metotreksata povećavaju se kada se asparaginaza primjenjuje 24 sata nakon terapije metotreksatom.
English: • coagulation disorders including symptomatic thrombosis related to the use of central venous catheters,
Croatian: • poremećaji koagulacije uključujući simptomatsku trombozu povezanu s upotrebom centralnih venskih katetera
English: Taking into account the PRAC Assessment Report on the PSUR(s) for asparaginase (centrally authorised product), the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za asparaginazu (lijek odobren centraliziranim postupkom), znanstveni zaključci CHMP-a su sljedeći:
English: Storage would normally not be longer than 24 hours at 2 °C - 8 °C.
Croatian: Čuvanje obično ne bi trebalo biti dulje od 24 sata na temperaturi 2 °C - 8 °C.
English: If allergic symptoms occur, intravenous infusion of Spectrila must be discontinued immediately.
Croatian: Ako se pojave simptomi alergije, intravensku infuziju Spectrile treba odmah obustaviti.
English: During treatment with asparaginase-containing regimens, myelosuppression, potentially affecting all three cell lines, and infections can occur.
Croatian: Tijekom liječenja režimima koji uključuju asparaginazu mogu se pojaviti mijelosupresija, koja potencijalno utječe na sve tri linije stanica, i infekcije.
English: Due to the asparagine concentration gradient between the extra- and intravascular space, asparagine levels are subsequently also reduced in the extravascular spaces, e.g. the cerebrospinal fluid.
Croatian: Zbog gradijenta koncentracije asparagina između ekstra i intravaskularnog prostora, razine asparagina posljedično su snižene i u ekstravaskularnim prostorima, npr. cerebrospinalnoj tekućini.
English: The metabolism of asparaginase is not known but thought to occur via degradation within the reticulohistiocytic system and by serum proteases.
Croatian: Metabolizam asparaginaze nije poznat, ali smatra se da se odvija putem degradacije unutar retikulohistiocitnog sustava te putem serumskih proteaza.
English: Changes in endocrine pancreatic function are observed very commonly during treatment with asparaginase and manifest predominantly as hyperglycaemia.
Croatian: Promjene endokrine funkcije gušterače opažene su vrlo često tijekom liječenja asparaginazom, a manifestiraju se uglavnom kao hiperglikemija.
English: Treatment group
Croatian: Terapijska skupina
English: Asparaginase lowers asparagine level in blood cancer cells and stops the cancer growing.
Croatian: Asparaginaza snižava razinu asparagina u krvnim stanicama raka i time zaustavlja i rast raka.
English: Neurological signs and symptoms including agitation, dizziness and somnolence
Croatian: Često neurološki znakovi i simptomi uključujući agitaciju, omaglicu i somnolenciju
English: Qualitatively, the same asparaginase-induced adverse drug reactions are observed in adults and children; however, some of these undesirable effects (e.g. thromboembolic events) are known to occur with a higher frequency in adult patients compared to the paediatric population.
Croatian: Kvalitativno gledano, nuspojave opažene uz primjenu asparaginaze jednake su i u odraslih i djece; međutim, poznato je da se neki od neželjenih učinaka (npr. tromboembolijski događaji) javljaju većom učestalošću u odraslih bolesnika u usporedbi s pedijatrijskom populacijom.
English: During induction treatment, asparaginase-typical adverse drug reactions like elevated liver enzymes/bilirubin (≥ CTCAE Grade III: 44.3 % vs. 39.6 %), haemorrhage or thromboembolism (≥ CTCAE Grade II: 2.1 % vs. 4.0 %), and neurotoxicity (≥ CTCAE Grade III: 4.1 % vs. 5.9 %) were observed in comparable frequencies in both groups (Spectrila versus reference).
Croatian: Tijekom indukcijskog liječenja, nuspojave na lijek tipične za asparaginazu poput povišenih jetrenih enzima/bilirubina (≥ CTCAE III. stupnja: 44,3% naspram 39,6%), hemoragija ili tromboembolija (≥ CTCAE II. stupnja: 2,1% naspram 4,0%) i neurotoksičnost (≥ CTCAE III. stupnja: 4,1% naspram 5,9%) opaženi su u sličnim učestalostima u obje skupine (Spectrila naspram referentni lijek).
English: Hypersensitivity including bronchospasm Rare
Croatian: Često preosjetljivost uključujući bronhospazam
English: Common Hypoglycaemia, decreased appetite, weight loss
Croatian: Često hipoglikemija, smanjeni apetit, gubitak težine
English: Clinical trials with asparaginase have shown that glutamine levels are only moderately affected with a very high interindividual variability.
Croatian: Klinička ispitivanja s asparaginazom pokazala su da na razine glutamina samo umjereno utječu vrlo velike interindividualne razlike.