natgillin/translations-raw huggingface dataset:
The toxicity of vincristine may be additive with that of asparaginase if both agents are administered concomitantly.
Toksičnost vinkristina se lahko sešteva s toksičnostjo asparaginaze, če damo bolniku obe zdravili sočasno.
Expert advice should be sought.
Treba je poiskati nasvet specialista.
Unconditional exact test of non-inferiority for binomial differences based on restricted maximum likelihood estimates c Patients were considered as responders if asparagine values in CSF on protocol day 33 were below the lower limit of quantification.
Brezpogojni natančni interval zaupanja po Chanu in Zhangu b Brezpogojni natančni preskus neinferiornosti za binomialne razlike na podlagi omejenih ocen največje verjetnosti c Veljalo je, da so se bolniki odzvali na zdravljenje, če so bile vrednosti asparagina v CSF na 33. dan po protokolu pod spodnjo mejo kvantitativnega določanja.
Effective contraception must be used during treatment and for at least 3 months after asparaginase discontinuation.
Med zdravljenjem in še vsaj 3 mesece po ukinitvi asparaginaze je treba uporabljati učinkovito kontracepcijo.
In a clinical trial in children with newly diagnosed ALL (study MC-ASP.5/ALL), the following frequencies of allergic events were observed (table 2).
V kliničnem preskušanju pri otrocih z na novo diagnosticirano ALL (študija MC-ASP.5/ALL) so ugotovili naslednje pogostnosti alergijskih dogodkov (preglednica 2).
Evidence from published data with asparaginase renders the mutagenic, clastogenic and carcinogenic potential of asparaginase negligible.
Sodeč po objavljenih podatkih za asparaginazo je mutageni, klastogeni in kancerogeni potencial asparaginaze zanemarljiv.
The metabolism of asparaginase is not known but thought to occur via degradation within the reticulohistiocytic system and by serum proteases.
Presnova asparaginaze ni znana, mislijo pa, da poteka preko degradacije v retikulo-histiocitnem sistemu in s posredovanjem serumskih proteaz.
What Spectrila is and what it is used for What you need to know before you are given Spectrila How to use Spectrila
Kaj je zdravilo Spectrila in za kaj ga uporabljamo Kaj morate vedeti, preden vam bodo dali zdravilo Spectrila Kako uporabljati zdravilo Spectrila Možni neželeni učinki
In case of occurrence of allergic symptoms, administration of Spectrila should be discontinued immediately (see section 4.4).
Če se pojavijo alergijski simptomi, je treba takoj prekiniti dajanje zdravila Spectrila (glejte poglavje 4.4).
Simultaneous vaccination with live vaccines may increase the risk of a serious infection.
Sočasno cepljenje z živimi cepivi lahko zveča tveganje za resne okužbe.
• severe liver function abnormalities (determined by laboratory tests),
• hude nenormalnosti v delovanju jeter (ugotavljajo se z laboratorijskim testiranjem),
Spectrila contains asparaginase, which is an enzyme that interferes with natural substances necessary for cancer cell growth.
Zdravilo Spectrila vsebuje asparaginazo, ki je encim, ki deluje na naravne snovi, potrebne za rast rakastih celic.
Asparaginase may increase the toxicity of other medicinal products through its effect on liver function, e.g. increased hepatotoxicity with potentially hepatotoxic medicines, increased toxicity of medicinal products metabolised by the liver or bound to plasma proteins and altered pharmacokinetics and pharmacodynamics of medicines bound to plasma proteins.
Asparaginaza lahko zveča toksičnost drugih zdravil s svojim vplivom na funkcijo jeter, na primer zvečana hepatotoksičnost potencialno hepatotoksičnih zdravil, zvečana toksičnost zdravil, ki se presnavljajo v jetrih ali vežejo na plazemske beljakovine, in spremenjena farmakokinetika in farmakodinamika zdravil, vezanih na plazemske beljakovine.
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Because of the risk of severe anaphylactic reactions asparaginase should not be administered as a bolus intravenous injection.
Zaradi tveganja hudih anafilaktičnih reakcij asparaginaze ne smemo dajati v obliki bolusne intravenske injekcije.
However, Spectrila should not be used in patients with severe hepatic impairment (see section 4.3).
Zdravilo Spectrila pa se ne sme uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
Hypersensitivity including bronchospasm Rare
Pogosti preobčutljivost, vključno z bronhospazmom
• if you have severe liver function problems,
• če imate velike težave z delovanjem jeter,
Laboratory in vitro and in vivo data indicate that the efficacy of high-dose cytarabine is reduced by prior administration of asparaginase.
Laboratorijski podatki in vitro in in vivo kažejo, da se učinkovitost velikih odmerkov citarabina zmanjša, če damo pred njim asparaginazo.
Clinical trials with asparaginase have shown that glutamine levels are only moderately affected with a very high interindividual variability.
Klinična preskušanja z asparaginazo so pokazala, da ta le zmerno vpliva na koncentracijo glutamina z zelo veliko interindividualno variabilnostjo.
Data on efficacy and safety of Spectrila in adults are limited.
Podatkov o učinkovitosti in varnosti zdravila Spectrila pri odraslih je malo.
The reconstituted solution may exhibit a slight opalescence.
Rekonstituirana raztopina je lahko rahlo opalescenčna.
The primary endpoint was the rate of patients with complete asparagine depletion in serum (defined as asparagine serum levels below the lower limit of quantification (< 0.5 µM) at all time points measured from day 12 up to day 33) during induction treatment.
Primarni končni opazovani dogodek je bil delež bolnikov s popolnim izčrpanjem asparagina v serumu (ki je bilo definirano kot koncentracija asparagina v serumu, nižja od spodnje meje kvantitativnega določanja (<0,5 µM) v vseh časovnih točkah, merjenih od 12. do 33. dne) med indukcijskim zdravljenjem.
Treatment group
Skupina zdravljenja
Spectrila is available in packs containing 1 or 5 vials.
Zdravilo Spectrila je na voljo v pakiranjih po 1 ali 5 vial.
• Medicines that reduce the ability of blood to clot, such as anticoagulants (e.g. warfarin and heparin), dipyridamole, acetylsalicylic acid or medicines to treat pain and inflammation, since using these medicines with asparaginase may increase the risk of bleeding.
• Zdravila, ki zmanjšujejo zmožnost krvi za strjevanje, na primer antikoagulanti (npr. varfarin in heparin), dipiridamol, acetilsalicilna kislina ali zdravila za zdravljenje bolečine in vnetja, ker uporaba teh zdravil skupaj z asparaginazo lahko zveča tveganje krvavitve.
Study in infants with de novo ALL
Študija pri dojenčkih z de novo ALL
Chemical and physical in-use stability has been demonstrated for 2 days at 2 °C - 8 °C.
Rekonstituirana in razredčena raztopina Kemijsko in fizikalno stabilnost med uporabo so dokazali za 2 dni pri 2 °C - 8 °C.
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).
Med indukcijskim zdravljenjem so ugotavljali za asparaginazo značilne neželene učinke, kot so zvišani jetrni encimi/bilirubin (≥CTCAE stopnje III: 44,3 % v primerjavi z 39,6 %), krvavitev ali trombembolija (≥ CTCAE stopnje II: 2,1 % v primerjavi s 4,0 %) in nevrotoksičnost (≥ CTCAE stopnje III: 4,1 % v primerjavi s 5,9 %), s primerljivimi pogostnostmi v obeh skupinah (zdravilo
Warnings and precautions Talk to your doctor or nurse before you are given Spectrila.
Opozorila in previdnostni ukrepi Preden vam dajo zdravilo Spectrila, se posvetujte z zdravnikom ali medicinsko sestro.
• Vincristine (used to treat certain types of cancer) since the simultaneous use of vincristine and asparaginase may increase the risk of certain side effects.
• Vinkristin (uporablja se za zdravljenje določenih vrst raka), ker lahko sočasna uporaba vinkristina in asparaginaze zveča tveganje za nekatere neželene učinke.
If severe liver problems occur, treatment with Spectrila must be interrupted immediately.
Če bodo nastopile hude težave z jetri, je treba nemudoma prekiniti zdravljenje z zdravilom Spectrila.
Spectrila is usually employed as part of combination chemotherapy protocols with other antineoplastic agents (see also section 4.5).
Zdravilo Spectrila se navadno uporablja kot del kombiniranih kemoterapevtskih protokolov z drugimi zdravili z delovanjem na novotvorbe (glejte tudi poglavje 4.5).
Efficacy and safety of Spectrila have not been established in Philadelphia chromosome-positive patients.
Varnosti in učinkovitosti zdravila Spectrila pri bolnikih, pozitivnih na kromosom Philadelphia, niso dokazali.
Symptoms of RPLS essentially include elevated blood pressure, seizures, headaches, changes in mental state and acute visual impairment (primarily cortical blindness or homonymous hemianopsia).
Simptomi RPLS v glavnem vključujejo zvišan krvni tlak, epileptične napade, glavobole, spremembe duševnega stanja in akutno okvaro vida (predvsem kortikalno slepoto ali homonimno hemianopsijo).
*Including all allergic reactions within 12 hours after asparaginase infusion and all adverse events with CTCAE terms syncope (fainting), hypotension, rash, flushing, pruritus, dyspnoea, injection site reaction or airway obstruction within 24 hours after asparaginase infusion
*Vključno z vsemi alergijskimi reakcijami v 12 urah po infuziji asparaginaze in vsemi neželenimi učinki, označenimi z izrazi CTCAE sinkopa (omedlevica), hipotenzija, izpuščaj, vročinski oblivi, pruritus, dispnea, reakcija na mestu injiciranja ali zapora dihalnih poti v 24 urah po infuziji asparaginaze.
Allergic reactions within 12 hours after asparaginase infusion during induction treatment Any allergic event* within 24 hours after asparaginase infusion during induction treatment
Zdravilo Spectrila Referenčna asparaginaza število bolnikov alergijske reakcije v 12 urah po infuziji asparaginaze med indukcijskim zdravljenjem kateri koli alergijski dogodek* v 24 urah po infuziji asparaginaze med indukcijskim zdravljenjem
Ischaemic strokes are rare.
Ishemične možganske kapi so redke.
It is unknown whether asparaginase is present in human breast milk.
Ni znano, ali je asparaginaza prisotna v materinem mleku.
Because potential serious adverse reactions may occur in nursing infants, Spectrila should be discontinued during breast-feeding.
Ker se lahko pri dojenih otrocih pojavijo potencialno resni neželeni učinki, je treba med dojenjem zdravljenje z zdravilom Spectrila prekiniti.
Absorption Asparaginase is not absorbed by the gastrointestinal tract, thus Spectrila must be given intravenously.
Absorpcija Asparaginaza se v prebavilih ne absorbira, zato moramo zdravilo Spectrila dajati intravensko.
After repeated administration of asparaginase at a dose of 5,000 U/m² every third day, trough asparaginase activity levels in serum ranged from 108 to 510 U/l.
Po ponovnem dajanju asparaginaze v odmerku 5.000 E/m² vsak tretji dan je bila najnižja raven aktivnosti asparaginaze v serumu v razponu od 108 to 510 E/l.
In a clinical trial in children with de novo ALL (study MC-ASP.4/ALL) it was shown that immediately after the end of infusion of asparaginase mean asparagine concentrations in serum dropped from the pre-dose concentrations of about 40 µM to below the lower limit of quantification of the bioanalytical method (< 0.5 µM).
V kliničnem preskušanju pri otrocih z de novo ALL (študija MC-ASP.4/ALL) so pokazali, da so se takoj po koncu infuzije asparaginaze srednje serumske koncentracije asparagina znižale s koncentracij pred odmerkom, ki so bile okrog 40 µM, na vrednosti pod spodnjo mejo kvantitativnega določanja bioanalitične metode (<0,5 µM).
• nervousness (agitation) or somnolence (sleepiness)
• živčnost (agitiranost) ali somnolenca (zaspanost),
Additionally it may decrease insulin secretion from pancreatic β-cells and impair insulin receptor function.
Poleg tega lahko zmanjša izločanje insulina iz pankreatičnih celic β in okvari delovanje insulinskih receptorjev.
No case of asparaginase overdose with clinical symptoms has been reported.
Poročali niso o nobenem primeru prevelikega odmerjanja asparaginaze s kliničnimi simptomi.
For intravenous use only.
SAMO za intravensko uporabo.
Even those few patients with trough asparaginase serum activity levels of 10 - 100 U/l usually experienced complete asparagine depletion in serum and CSF.
Celo pri tistih nekaj bolnikih, ki so imeli najnižjo raven serumske aktivnosti asparaginaze 10-100 E/l, je navadno bilo prisotno popolno izčrpanje asparagina v serumu in CSF.
Colourless 20 ml glass vial (Type I glass) closed with butylrubber stopper, aluminium seal and plastic flip-off cap, containing 10,000 units of asparaginase.
Brezbarvna 20-mililitrska steklena viala (steklo tipa 1), zaprta z zamaškom iz butilne gume, aluminijasto zaporko in plastičnim dvižnim pokrovčkom, ki vsebuje 10.000 enot asparaginaze.
Reversible posterior leukoencephalopathy syndrome (characterised by headache, confusion, seizures and visual loss) may require blood-pressure lowering medicines and in case of seizure, anti-epileptic treatment.
Pri sindromu reverzibilne posteriorne levkoencefalopatije (za katerega so značilni glavobol, zmedenost, epileptični napadi in okvara vida) bodo morda potrebna zdravila za znižanje krvnega tlaka in, v primeru epileptičnih napadov, antiepileptično zdravljenje.
• acute pancreatitis,
• akutni pankreatitis,
Frequent evaluation of coagulation parameters is important before and during asparaginase treatment.
Pogosto določanje koagulacijskih parametrov je pomembno pred zdravljenjem z asparaginazo in med njim.
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).
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Spectrila ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji, posebno prek svojih potencialnih učinkov na živčevje in prebavila (glejte poglavje 4.8).
How to use Spectrila
Kako uporabljati zdravilo Spectrila
Asparaginase-associated hyperlipidaemia should be treated depending on its severity and on clinical symptoms.
Hiperlipidemijo, povezano z asparaginazo, moramo zdraviti odvisno od njene izraženosti in od kliničnih simptomov.
This antagonism is observed if asparaginase is administered prior to or concurrently with methotrexate.
Ta antagonizem je viden, če damo asparaginazo prej kot metotreksat ali sočasno z njim.
Expert advice should be sought in cases where AT III is decreased.
V primerih, ko je znižan AT III, je treba poiskati nasvet specialista.
Marketing Authorisation Holder and Manufacturer medac
Imetnik dovoljenja za promet z zdravilom in izdelovalec medac
17.33 (12.54 - 22.91) h
17,33 (12,54-22,91) h skupni očistek
One vial contains 10,000 units of asparaginase.
Ena viala vsebuje 10.000 enot asparaginaze.
• blood clotting disorders (bleeding or formation of blood clots),
• motnje strjevanja krvi (krvavitev ali nastanek krvnih strdkov),
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 10,000 units of asparaginase*.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 10.000 enot asparaginaze*.
6,700 U/m² BSA,
6.700 E/m² telesne površine,
There have been reports of transitory secondary hypothyroidism probably caused by a decrease in the serum thyroxin-binding globulin due to asparaginase-induced protein synthesis inhibition.
Poročali so o prehodnem sekundarnem hipotiroidizmu, ki ga verjetno povzroča zmanjšanje serumskega globulina, ki veže tiroksin, zaradi inhibicije sinteze beljakovin, ki jo povzroča asparaginaza.
Women of childbearing potential/Contraception in males and females Women of childbearing potential have to use effective contraception and avoid becoming pregnant while being treated with asparaginase-containing chemotherapy.
Ženske v rodni dobi/Kontracepcija pri moških in ženskah Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo in ne smejo zanositi, ko se zdravijo s kemoterapijo, katere del je asparaginaza.
Difference (95 % CIa)
da c ne ni mogoče oceniti razlika (95 % CI
It is unknown whether asparaginase is excreted into human breast milk.
Ni znano, ali se asparaginaza pri človeku izloča v materino mleko.
Pharmacokinetic parameters after administration of 5,000 U/m² of Spectrila were determined in 14 children/adolescents (age 2 - 14 years) with de novo ALL (study MC-ASP.4/ALL).
Pediatrična populacija Farmakokinetične parametre po dajanju 5.000 E/m zdravila Spectrila so določili pri 14 otrocih/mladostnikih (starih 2-14 let) z de novo ALL (študija MC-ASP.4/ALL).
Liver parameters should be monitored closely before and during treatment with asparaginase.
Jetrne parametre je treba skrbno spremljati pred zdravljenjem z asparaginazo in med njim.
As a result of asparaginase-induced asparagine depletion in serum, protein synthesis in lymphoblastic tumour cells is disturbed while sparing most normal cells.
Kot rezultat izčrpanja asparagina v serumu, ki ga povzroči asparaginaza, je sinteza beljakovin v limfoblastnih tumorskih celicah motena, kar pa ne vpliva na večino normalnih celic.
Spectrila should be prescribed and administered by physicians and health care personnel experienced in the use of antineoplastic products.
Zdravilo Spectrila smejo predpisovati in dajati le zdravniki in zdravstveno osebje, ki imajo izkušnje z uporabo zdravil z delovanjem na novotvorbe.
• allergic reactions including wheezing (bronchospasm) or difficulty in breathing
• alergijske reakcije, vključno s sopenjem (bronhospazem) ali z oteženim dihanjem,
Very rare
Zelo redki tremor
Coagulation disorders
Motnje koagulacije
Clinical symptoms include abdominal pain, nausea, vomiting and anorexia.
Klinični simptomi vključujejo bolečine v trebuhu, navzeo, bruhanje in anoreksijo.
In an uncontrolled clinical trial (study MC-ASP.6/INF), 12 infants (median age [range] at time of first infusion: 6 months [0.5 - 12.2 months]) with de novo ALL were treated with Spectrila within the
V nekontroliranem kliničnem preskušanju (študija MC-ASP.6/INF) so zdravili 12 dojenčkov (mediana starost [razpon] v času prve infuzije: 6 mesecev [0,5-12,2 meseca]) z de novo ALL z zdravilom Spectrila po protokolu INTERFANT-06.
Your doctor decides on the dose you receive.
Odmerek, ki ga boste prejeli, bo določil vaš zdravnik.
Name and address of the manufacturer(s) responsible for batch release medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Ime in naslov izdelovalca, odgovornega za sproščanje serij medac Gesellschaft für klinische Spezialpräparate mbH
The powder is white and it is supplied in a clear glass vial with a rubber stopper and an aluminium seal and a plastic flip-off cap.
Prašek je bel in je na voljo v viali iz prozornega stekla z gumijastim zamaškom, aluminijasto zaporko in plastičnim dvižnim pokrovčkom.
Neurological signs and symptoms including agitation, dizziness and somnolence
Pogosti nevrološki znaki in simptomi, vključno z agitiranostjo, omotičnostjo in zaspanostjo
Reversible posterior leukoencephalopathy syndrome Reversible posterior leukoencephalopathy syndrome (RPLS) may occur rarely during treatment with any asparaginase (see section 4.8).
Sindrom reverzibilne posteriorne levkoencefalopatije Sindrom reverzibilne posteriorne levkoencefalopatije (RPLS) se lahko redko pojavi med zdravljenjem s katero koli asparaginazo (glejte poglavje 4.8).
MRD status at end of induction treatment MRD negative
Status MRD na koncu indukcijskega zdravljenja
The following life-threatening situations may arise during asparaginase treatment in patients of all age groups:
Med zdravljenjem z asparaginazo se lahko pri bolnikih vseh starostnih skupin pojavijo naslednja smrtno nevarna stanja:
Caution is therefore needed when anticoagulants (e.g. coumarin, heparin, dipyridamole, acetylsalicylic acid or nonsteroidal anti-inflammatory medicinal products) or glucocorticoids are given at the same time.
Zato je ob sočasnem dajanju antikoagulantov (npr. kumarin, heparin, dipiridamol, acetilsalicilno kislino ali nesteroidna protivnetna zdravila) ali glukokortikoidov, potrebna previdnost.
• Glucocorticoids (anti-inflammation medicines that dampen down your immune system) since the simultaneous use of glucocorticoids and asparaginase may increase the formation of blood clots (thrombosis).
• Glukokortikoidi (protivnetna zdravila, ki omilijo odziv vašega imunskega sistema), ker lahko sočasna uporaba glukokortikoidov in asparaginaze zveča nastajanje krvnih strdkov (tromboza).
• If you have any further questions, ask your doctor or nurse.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom ali medicinsko sestro.
• liver problems,
• težave z jetri,
Hyperammonaemia and sinus vein thrombosis may need to be excluded.
Mogoče bo treba izključiti hiperamonemijo in trombozo venskih sinusov.
In rare cases severe liver impairment has been described, including cholestasis, icterus, hepatic necrosis and hepatic failure with fatal outcome (see sections 4.8 and 4.5).
Hepatotoksičnost V redkih primerih so opisali hudo okvaro jeter, vključno s holestazo, zlatenico, nekrozo jeter in odpovedjo jeter s smrtnim izidom (glejte poglavji 4.8 in 4.5).
The reconstituted solution is stable for 2 days when stored at 2 °C - 8 °C.
Rekonstituirana raztopina je stabilna 2 dni, če jo hranimo pri 2 °C-8 °C.
0.053 (0.043 - 0.178) l/h
0,053 (0,043-0,178) l/h porazdelitveni volumen
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 14 January 2016
14. januar 2016
Table 3: Efficacy results (MC-ASP.5/ALL; Full analysis set)
Preglednica 3: Rezultati učinkovitosti (MC-ASP.5/ALL; analiza vseh podatkov) Skupina glede na zdravilo
• Other anti-cancer medicines as they may contribute to the release of too much uric acid when tumour cells are destroyed by asparaginase.
• Druga zdravila z delovanjem na novotvorbe, ker lahko prispevajo k sproščanju prevelikih količin sečne kisline, ko asparaginaza uniči rakaste celice.
Immunisation with live vaccines should therefore take place at the earliest 3 months after completion of the course of antileukaemic treatment.
Zato ne smemo imunizirati bolnika z živimi vakcinami prej kot 3 mesece po dokončanju sheme antilevkemičnega zdravljenja.
In case of hyperammonaemia with severe clinical symptoms, therapeutic and pharmacological measures that rapidly reduce plasma ammonia levels (e.g. protein restriction and haemodialysis), reverse catabolic states and increase removal of nitrogen wastes should be initiated and expert advice sought.
V primeru hiperamonemije s hudimi kliničnimi simptomi je treba uvesti terapevtske in farmakološke ukrepe, ki hitro zmanjšajo koncentracijo amoniaka v plazmi (npr. omejitev beljakovin in hemodializa), odpravijo katabolična stanja in zvečajo odstranjevanje dušikovih odpadnih snovi, ter poiskati nasvet specialista.
Asparaginase hydrolyses asparagine to aspartic acid and ammonia.
Mehanizem delovanja Asparaginaza hidrolizira asparagin v asparaginsko kislino in amoniak.
In clinical trials with asparaginase, trough asparaginase serum activity levels greater than 100 U/l were achieved in the majority of patients which nearly always correlated with a complete depletion of asparagine in serum and cerebrospinal fluid (CSF).
V kliničnih preskušanjih z asparaginazo je večina bolnikov dosegla najnižjo raven serumske aktivnosti asparaginaze več kot 100 E/l, kar je skoraj vedno sovpadalo s popolnim izčrpanjem asparagina v serumu in cerebrospinalni tekočini (CSF).
• if you have a blood clotting disorder (such as haemophilia),
• če imate bolezen strjevanja krvi (na primer hemofilijo).
• infections
• okužbe,
Common Pain (back pain, joint pain)
Pogosti bolečina (bolečina v hrbtu, bolečina v sklepih)
Hypothyroidism
Hipotiroidizem
The diluted solution of asparaginase may be infused over 0.5 to 2 hours.
Razredčeno raztopino asparaginaze lahko infundirate 0,5 ure do 2 uri.
Nausea/vomiting are very commonly observed in patients treated with asparaginase-containing treatment regimens but are usually mild.
Navzeo in bruhanje zelo pogosto opažajo pri bolnikih, zdravljenih s terapevtskimi shemami, ki vsebujejo asparaginazo, a sta navadno blaga.