natgillin/translations-raw huggingface dataset:
Measurement of the asparaginase activity level in serum or plasma may be undertaken in order to rule out accelerated reduction of asparaginase activity.
Merjenje aktivnosti asparaginaze v serumu ali plazmi lahko opravimo, da izključimo možnost pospešenega zmanjšanja aktivnosti asparaginaze.
Acquired or genetically decreased physiologic coagulation inhibitors (protein C, protein S, antithrombin) are also described in relation to vascular complications.
V zvezi z žilnimi zapleti opisujejo tudi pridobljene ali genetsko zmanjšane fiziološke inhibitorje koagulacije (protein C, protein S, antitrombin).
If asparaginase activity values fail to reach target levels, a switch to a different asparaginase preparation could be considered (see section 4.4).
Če vrednosti aktivnosti asparaginaze ne dosežejo ciljnih ravni, bi lahko prišla v poštev zamenjava z drugim zdravilom z asparaginazo (glejte poglavje 4.4).
Study in children/adolescents aged 1 - 18 years with de novo ALL Efficacy and safety of Spectrila was compared to a native E. coli-asparaginase (reference medicinal product) in a randomised double-blinded clinical trial (study MC-ASP.5/ALL; based on ALL treatment protocol DCOG ALL10) in 199 children/adolescents aged 1 - 18 years with de novo ALL.
Učinkovitost in varnost zdravila Spectrila so primerjali z nativno asparaginazo E. coli (referenčno zdravilo) v randomiziranem dvojno slepem kliničnem preskušanju (študija MC-ASP.5/ALL; na podlagi protokola zdravljenja ALL DCOG ALL10) pri 199 otrocih/mladostnikih, starih 1-18 let z de novo ALL.
Since an indirect interaction between components of the oral contraception and asparaginase cannot be ruled out, oral contraceptives are not considered sufficiently safe in such clinical situation (see section 4.6).
Ker ni mogoče izključiti posredne interakcije med učinkovinami v peroralnih kontraceptivih in asparaginazo, peroralni kontraceptivi v taki klinični situaciji niso dovolj varni (glejte poglavje 4.6).
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1072/001 (1 vial)
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1072/001 (1 viala)
The recommended dose in infants aged 0 - 12 months is as follows: - age less than 6 months:
Priporočeni odmerki za dojenčke, stare 0-12 mesecev, so:
As a result of impaired protein synthesis, the serum protein level (especially albumin) decreases very commonly in patients treated with asparaginase.
Zaradi motene sinteze beljakovin se raven serumskih beljakovin (posebno albumina) pri bolnikih, zdravljenih z asparaginazo, zelo pogosto zmanjša.
Pancreatitis with fatal outcome, pancreatic pseudocyst
Zelo redki pankreatitis s smrtnim izidom, pankreatična psevdocista
Spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults.
4.1 Terapevtske indikacije Zdravilo Spectrila je indicirano kot sestavni del kombinirane terapije z delovanjem na novotvorbe za zdravljenje akutne limfoblastne levkemije (ALL) pri pediatričnih bolnikih od rojstva do starosti 18 let in odraslih.
Inhibition of protein synthesis secondary to the asparaginase-induced depletion of asparagine has been shown to attenuate the cytotoxic effect of MTX which requires cell replication for its antineoplastic activity.
Metotreksat (MTX) Ugotovili so, da inhibicija sinteze beljakovin zaradi izpraznitve zalog asparagina, ki jo povzroči asparaginaza, zmanjša citotoksični učinek MTX, ki za svojo aktivnost proti novotvorbam potrebuje replikacijo celic.
Trough serum activity levels were measured in 12 infants (age from birth to 1 year) with de novo ALL (study MC-ASP.6/INF).
Najnižjo raven serumske aktivnosti so merili pri 12 dojenčkih (starost od rojstva do 1 leta) z de novo ALL (študija MC-ASP.6/INF).
Taking into account the PRAC Assessment Report on the PSUR(s) for asparaginase (centrally authorised product), the scientific conclusions of CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za asparaginazo (zdravilo, ki je pridobilo dovoljenje za promet po centraliziranem postopku), je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
Measurement of the asparaginase activity level in serum or plasma may be undertaken in order to rule out accelerated elimination of asparaginase activity.
Merjenje aktivnosti asparaginaze v serumu ali plazmi lahko opravimo, da izključimo možnost pospešene eliminacije aktivnosti asparaginaze.
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.
Asparaginaza je pri več živalskih vrstah, med drugim pri miših, podganah in/ali kuncih, povzročila zvečano incidenco malformacij (vključno z malformacijami centralnega živčevja, srca in skeleta) in fetalnih smrti v odmerkih, ki so podobni tistim ali večji od tistih, ki so predlagani za klinično uporabo
METHOD OF ADMINISTRATION Read the package leaflet before use.
POSTOPEK UPORABE Pred uporabo preberite priloženo navodilo!
In rare cases, diabetic ketoacidosis has been reported.
V redkih primerih so poročali o diabetični ketoacidozi.
It is strongly recommended that every time Spectrila is administered to a patient, the tradename and batch number of the product should clearly be recorded in order to link the patient and the batch of the product.
Vsakokrat, ko damo bolniku zdravilo Spectrila, moramo zabeležiti ime in serijo zdravila, da tako ohranimo sledljivost med bolnikom in serijo zdravila.
Reversible posterior leukoencephalopathy syndrome Reversible posterior leukoencephalopathy syndrome (RPLS) may occur rarely during treatment with any asparaginase.
Sindrom reverzibilne posteriorne levkoencefalopatije Sindrom reverzibilne posteriorne levkoencefalopatije (RPLS) se lahko redko pojavi med zdravljenjem s katero koli asparaginazo.
Adverse central nervous system reactions observed in patients treated with asparaginase-containing therapy protocols include changes in EEG, seizures, dizziness, somnolence, coma and headache.
Neželeni učinki na centralno živčevje, ki so jih opazili pri bolnikih, zdravljenih s terapevtskimi protokoli, ki vsebujejo asparaginazo, vključujejo spremembe EEG, epileptične napade, omedlevico,
• Severe hepatic impairment (bilirubin > 3 times upper limit of normal [ULN]; transaminases
• huda okvara jeter (bilirubin > 3-krat zgornja meja normalnih vrednosti [ULN-upper limit of normal]; transaminaze > 10-krat višje od ULN).
Hyperammonaemia has been reported uncommonly in patients treated with asparaginase-containing therapy protocols, especially if patients suffer additionally from hepatic impairment.
O hiperamonemiji so občasno poročali pri bolnikih, zdravljenih s terapevtskimi protokoli, ki vsebujejo asparaginazo, še posebno pri bolnikih z okvaro jeter.
Hepatic parameters should be monitored when potentially hepatotoxic medicinal products are given concomitantly with asparaginase (see sections 4.4 and 4.8).
Kadar bolnik sočasno z asparaginazo prejema potencialno hepatotoksična zdravila, je treba spremljati jetrne parametre (glejte poglavji 4.4 in 4.8).
Most frequently (very common) observed side effects of Spectrila include hypersensitivity reactions, hyperglycaemia, hypoalbuminaemia, nausea, vomiting, diarrhoea, abdominal pain, oedema, fatigue, and change in laboratory parameters (e.g. transaminases, bilirubin, blood lipids, coagulation parameters).
Med najpogosteje (zelo pogosti) opaženimi neželenimi učinki zdravila Spectrila so preobčutljivostne reakcije, hiperglikemija, hipoalbuminemija, navzea, bruhanje, driska, bolečine v trebuhu, edemi, utrujenost in spremembe laboratorijskih parametrov (npr. transaminaze, bilirubin, lipidi v krvi, koagulacijski parametri).
7,500 U/m² BSA.
7.500 E/m² telesne površine.
• Asparaginase may influence the efficacy of methotrexate or cytarabine (used to treat certain types of cancer): - if asparaginase is given after these agents their effect may be increased.
• Asparaginaza lahko vpliva na učinkovitost metotreksata ali citarabina (ki se uporabljata za zdravljenje nekaterih vrst raka): če damo najprej ti zdravili in potem asparaginazo, se lahko njuni učinki zvečajo, če damo najprej asparaginazo in potem ti zdravili, se lahko njuni učinki zmanjšajo.
The diluted solution of asparaginase should be infused over 0.5 to 2 hours.
Infundiranje razredčene raztopine asparaginaze mora trajati 0,5 ure do 2 uri.
• low blood sugar level (hypoglycaemia)
• nizka raven sladkorja v krvi (hipoglikemija),
Dissolution of the contents is achieved by slow turning (avoid froth formation due to shaking).
Vsebino raztopite tako, da vialo počasi obračate (pazite, da ne bo nastala pena zaradi stresanja).
Allergic reactions can manifest as flushing, rash, pain (joint pain, back pain and abdominal pain), hypotension, oedema/angioedema, urticaria, dyspnoea, bronchospasm up to anaphylactic shock.
Alergijske reakcije se lahko kažejo kot vročinski oblivi, izpuščaj, bolečina (bolečina v sklepih, bolečina v križu in bolečina v trebuhu), hipotenzija, edem/angioedem, urtikarija, dispneja, bronhospazem in vse do anafilaktičnega šoka.
Spectrila is given into a vein.
Zdravilo Spectrila se daje v veno.
The recommended intravenous dose of asparaginase is 5,000 units per square metre (U/m²) body surface area (BSA) given every third day.
Priporočeni intravenski odmerek asparaginaze je 5.000 enot na kvadratni meter (E/m²) telesne površine vsak tretji dan.
3,527 (2,231 - 4,526) U/l
3.527 (2.231-4.526) E/l čas do Cmax
Ischaemic stroke, reversible posterior leukoencephalopathy syndrome (RPLS), convulsion, disturbances in consciousness including coma
Občasni glavoboli Redki ishemična možganska kap, sindrom reverzibilne posteriorne levkoencefalopatije (RPLS), konvulzije, motnje zavesti vključno s komo
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1072/001
ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/15/1072/001
Hypersensitivity reactions range from transient flushing or rash and urticaria to bronchospasm, angioedema and anaphylaxis.
Preobčutljivostne reakcije segajo od prehodnih vročinskih oblivov ali izpuščaja in urtikarije do bronhospazma, angioedema in anafilaksije.
Decreased protein synthesis can predominantly lead to liver impairment, acute pancreatitis, decreased insulin production with hyperglycaemia, decreased production of clotting factors (especially fibrinogen and antithrombin III) leading to coagulation disorders (thrombosis, bleeding), and decreased production of lipoproteins resulting in hypertriglyceridaemia.
V glavnem lahko zmanjšana sinteza beljakovin povzroči okvaro jeter, akutni pankreatitis, zmanjšano nastajanje insulina s hiperglikemijo, zmanjšano nastajanje koagulacijskih faktorjev (predvsem fibrinogena in antitrombina III), kar povzroči motnje koagulacije (tromboza, krvavitev), in zmanjšano nastajanje lipoproteinov, ki povzroči hipertrigliceridemijo.
These patients should no longer be treated with any asparaginase preparation (see also sections 4.3 and 4.8).
Ti bolniki se ne smejo več zdraviti z nobenim zdravilom z asparaginazo (glejte tudi poglavji 4.3
You should therefore not receive vaccination with live vaccines until at least 3 months after the end of treatment with Spectrila.
Zato se najmanj 3 mesece po končanem zdravljenju z zdravilom Spectrila ne smete cepiti z živimi cepivi.
Asparaginase is produced by recombinant DNA technology in a microorganism named Escherichia coli.
DNA v mikroorganizmu, ki se imenuje Escherichia coli.
The recommended dose of Spectrila for adults is 5,000 U per m² body surface area (BSA) given every third day.
Priporočeni odmerek zdravila Spectrila za odrasle je 5.000 E na m² telesne površine, ki se daje vsak tretji dan.
• seizures, severe impairment of consciousness including coma, and stroke
• epileptični napadi, huda okvara zavesti vključno s komo in možganska kap,
• high blood levels of amylase and lipase
• visoka raven amilaze in lipaze v krvi,
Asparaginase does not seem to penetrate the blood-brain barrier in measurable amounts.
Zdi se, da asparaginaza ne prehaja v merljivih količinah skozi krvno-možgansko pregrado.
Median (range) serum trough asparaginase activities on days 18, 25, and 33 were 209 (42 - 330) U/l, 130 (6 - 424) U/l, and 32 (1 - 129) U/l, respectively.
in 33. dan je bila 209 (42 - 330) E/l, 130 (6 - 424) E/l oziroma 32 (1 - 129) E/l.
The following adverse reactions, listed in table 1, have been accumulated from clinical trials with Spectrila in 125 children with newly diagnosed acute lymphoblastic leukaemia as well as postmarketing experience with other E. coli-derived asparaginase preparations in children and adults.
Spectrila pri 125 otrocih z na novo diagnosticirano akutno limfoblastno levkemijo in iz izkušenj v obdobju trženja drugih zdravil z asparaginazo, ki izvirajo iz E. coli, pri otrocih in odraslih.
• accumulation of fluid (oedema)
• kopičenje tekočine (edem),
Thrombosis especially cavernous sinus thrombosis or deep vein thrombosis, haemorrhage
Pogosti tromboza, predvsem tromboza kavernoznega sinusa ali globoka venska tromboza, krvavitev
LIST OF EXCIPIENTS Excipient: sucrose.
SEZNAM POMOŽNIH SNOVI Pomožna snov: saharoza.
Anorexia, loss of appetite, abdominal cramps, diarrhoea and weight loss have also been reported.
Poročali so tudi o anoreksiji, izgubi apetita, trebušnih krčih, driski in hujšanju.
• Medicines which are metabolised in the liver, because the risk of side effects may increase.
• Zdravila, ki se presnavljajo v jetrih, ker se lahko zveča tveganje za neželene učinke.
Very rare (may affect up to 1 in 10,000 people):
Zelo redki (lahko se pojavijo pri največ 1 od 10.000 bolnikov):
Since an indirect interaction between components of the oral contraception and asparaginase cannot be ruled out, oral contraceptives are not considered sufficiently safe.
Ker ni mogoče izključiti posredne interakcije med učinkovinami v peroralnih kontraceptivih in asparaginazo, peroralni kontraceptivi niso dovolj varni.
Asparaginase may induce hyperglycaemia as a consequence of decreased insulin production.
Asparaginaza lahko povzroči hiperglikemijo zaradi zmanjšanega nastajanja insulina.
Very rare Secondary hypothyroidism, hypoparathyroidism
Bolezni endokrinega sistema Zelo redki sekundarni hipotiroidizem, hipoparatiroidizem
• feeling of tiredness
• občutek utrujenosti,
Most serious side effects of Spectrila include severe hypersensitivity reactions such as anaphylactic shock (rare), thromboembolic events (common), acute pancreatitis (common), and severe hepatotoxicity, e.g. jaundice, hepatic necrosis, hepatic failure (rare).
Večina resnih neželenih učinkov zdravila Spectrila vključuje hude preobčutljivostne reakcije, na primer anafilaktični šok (redek), trombembolične dogodke (pogosti), akutni pankreatitis (pogost) in hudo hepatotoksičnost, npr. zlatenico, nekrozo jeter, odpoved jeter (redka).
Haemorrhagic pancreatitis, necrotising pancreatitis, parotitis Very rare
Redki hemoragični pankreatitis, nekrozantni pankreatitis, parotitis
Increase in amylase, lipase, abnormal electroencephalogram (EEG) (reduced alpha wave activity, increased theta and delta wave activity)
lipoproteina majhne gostote (LDL), celotnih beljakovin Pogosti zvišanje amilaze, lipaze, abnormalen elektroencefalogram (EEG) (zmanjšana aktivnost valov alfa, zvečana aktivnost valov theta in delta)
Fertility No human data on the effect of asparaginase on fertility are available.
Ni podatkov o učinku asparaginaze na plodnost pri ljudeh.
As a result of impaired protein synthesis, the serum protein level (especially albumin) decreases very commonly in patients treated with asparaginase (see section 4.4).
Kot posledica ovirane sinteze beljakovin se pri bolnikih, zdravljenih z asparaginazo, zelo pogosto zniža raven serumskih beljakovin (posebno albuminov) (glejte poglavje 4.4).
60,165 (38,627 - 80,764) U*h/l
60.165 (38.627-80.764) E*h/l največja koncentracija v serumu (Cmax)
Allergy and anaphylaxis
Alergija in anafilaksija
Since an indirect interaction between components of the oral contraception and asparaginase cannot be ruled out, oral contraceptives are not considered sufficiently safe in such clinical situation.
Ker ni mogoče izključiti posredne interakcije med učinkovinami v peroralnih kontraceptivih in asparaginazo, peroralni kontraceptivi v taki klinični situaciji niso dovolj varni.
Increase in transaminases, blood bilirubin, blood alkaline phosphatase, blood cholesterol, blood triglyceride, very low density lipoprotein (VLDL), lipoprotein lipase activity, blood urea, ammonia, blood lactate dehydrogenase (LDH), Decrease in antithrombin III, blood fibrinogen, blood cholesterol, low density lipoprotein (LDL), total protein
holesterola v krvi, trigliceridov v krvi, lipoproteina zelo majhne gostote (VLDL), aktivnosti lipoproteinske lipaze, sečnine v krvi, amoniaka, laktatne dehidrogenaze (LDH) v krvi znižanje antitrombina III, fibrinogena v krvi, holesterola v krvi,
• inflammation of the salivary glands (parotitis)
• vnetje slinavk (parotitis),
A few cases of asparaginase-induced parotitis have been reported in the literature.
V literaturi so poročali o redkih primerih parotitisa, povzročenega z asparaginazo.
• Medicines which may have a negative effect on liver function since these negative effects may be worsened by concomitant treatment with asparaginase.
• Zdravila, ki bi lahko negativno vplivala na delovanje jeter, ker lahko sočasno zdravljenje z asparaginazo poslabša te negativne učinke.
The daily amount of asparaginase needed per patient can be diluted in a final volume of 50 - 250 ml sodium chloride 9 mg/ml (0.9 %) solution for injection.
Dnevno količino asparaginaze, ki jo bolnik potrebuje, lahko razredčite v končnem volumnu 50-250 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
Hans-Knoell-Str. 3
Wacker Biotech GmbH Hans-Knoell-Str. 3 07745 Jena
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).
Pomemben dejavnik, ki prispeva k temu, je sočasno zdravljenje z mielosupresivnimi zdravili in zdravili, za katera je znano, da povzročajo okužbe, zato je treba bolnike skrbno spremljati glede znakov in simptomov mielosupresije in okužb
Asparaginase-induced tumour cell destruction may release large amounts of uric acid, resulting in hyperuricaemia.
Ob odmrtju tumorskih celic, ki ga povzroči asparaginaza, se lahko sprosti velika količina sečne kisline, ki povzroči hiperurikemijo.
• hyperglycaemic conditions.
• hiperglikemična stanja.
Spectrila is for administration by intravenous infusion only.
Zdravilo Spectrila se aplicira samo z intravenskim infundiranjem.
Hepatic failure with potentially fatal outcome, hepatic necrosis, cholestasis, jaundice
Redki odpoved jeter z možnim smrtnim izidom, nekroza jeter, holestaza,
Pharmacotherapeutic group: Antineoplastic agents; Other antineoplastic agents ATC code: L01XX02
oznaka ATC: L01XX02
Hyperglycaemia and hypoglycaemia
Hiperglikemija in hipoglikemija
• inflammation of the pancreas, which causes severe pain in the abdomen and back,
• vnetje trebušne slinavke, ki povzroča močne bolečine v trebuhu in križu,
No dose adjustment is necessary in patients with mild to moderate hepatic impairment.
Pri bolnikih z blago do zmerno okvaro jeter prilagajanje odmerjanja ni potrebno.
Storage would normally not be longer than 24 hours at 2 °C - 8 °C.
Shranjevanje naj bi normalno ne trajalo dalj od 24 ur pri
Not known Infections
Infekcijske in parazitske bolezni Neznana okužbe
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA
• cholestasis (blocked bile flow from the liver)
• holestaza (oviran odtok žolča iz jeter),
• blood clotting disorders such as bleeding, disseminated intravascular coagulation (DIC) or formation of blood clots (thrombosis),
• motnje strjevanja krvi, na primer krvavitev, diseminirana intravaskularna koagulacija (DIK) ali nastajanje krvnih strdkov (tromboza), • visoka raven sladkorja v krvi (hiperglikemija).
PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial
FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje
The ready-to-use solution may exhibit a slight opalescence.
Raztopina, pripravljena za uporabo, je lahko rahlo opalescenčna.
Based on limited data, the recommended dose in infants is as follows: - age less than 6 months:
Na podlagi malo podatkov je priporočeni intravenski odmerek pri dojenčkih:
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Treatment with asparaginase should be interrupted if patients develop severe hepatic impairment (bilirubin > 3 times the upper limit of normal [ULN]; transaminases > 10 times ULN), severe hypertriglyceridaemia, hyperglycaemia or coagulation disorder (e.g. sinus vein thrombosis, severe bleeding).
> 3-krat zgornja meja normalnih vrednosti [ULN-upper limit of normal]; transaminaze > 10-krat višje od ULN), huda hipertrigliceridemija, hiperglikemija ali motnja koagulacije (npr. tromboza venskih sinusov, huda krvavitev).
Uncommon side effects (may affect up to 1 in 100 people):
Občasni neželeni učinki (lahko se pojavijo pri največ 1 od 100 bolnikov):
A higher risk of thrombosis during induction therapy with asparaginase and prednisone was seen in children with a genetic prothrombotic risk factor (factor V G1691A-mutations, prothrombin G20210A-variation, methylenetetrahydrofolate reductase [MTHFR] T677T-genotype, increased lipoprotein A, hyperhomocysteinaemia).
Pri otrocih z dednimi protrombotičnimi dejavniki tveganja (mutacije faktorja V G1691A, variacija protrombina G20210A, genotip T677T metilentetrahidrofolat-reduktaze [MTHFR], zvišan lipoprotein A, hiperhomocisteinemija) so ugotavljali večje tveganje tromboze med indukcijskim zdravljenjem z asparaginazo in prednizonom.
In rare cases, haemorrhagic or necrotising pancreatitis occurs.
V redkih primerih se pojavi hemoragični ali nekrozantni pankreatitis.
• History of pancreatitis, serious haemorrhage or serious thrombosis with prior asparaginase therapy.
• predhodna znana koagulopatija (npr. hemofilija) • Anamneza pankreatitisa, resne krvavitve ali resne tromboze pri predhodnem zdravljenju z asparaginazo.
As a consequence of hypoalbuminaemia oedema can occur.
Kot posledica se lahko pojavijo edemi zaradi hipoalbuminemije.
Hyperglycaemic conditions
Hiperglikemična stanja
Co-administration of other antineoplastic medicinal products contributes to this effect.
Sočasna uporaba drugih zdravil z delovanjem na novotvorbe prispeva k temu učinku.
What Spectrila contains
Kaj vsebuje zdravilo Spectrila
• decreased function of the thyroid gland or the parathyroid glands
• zmanjšano delovanje ščitnice ali obščitnic,
No allergic reactions were observed in any of the 12 infants < 1 year of age during treatment with Spectrila (study MC-ASP.6/INF).
Med zdravljenjem z zdravilom Spectrila niso pri nobenem od 12 dojenčkov, mlajših od 1 leta, opazili alergijskih reakcij (študija MC-ASP.6/INF).
• pseudocysts of the pancreas (collections of fluid after acute inflammation of the pancreas)
• psevdociste pankreasa (zbiri tekočine po akutnem vnetju trebušne slinavke).
Mild to moderate changes in blood lipid values (e.g. increased or decreased cholesterol, increased triglyceride, increased VLDL fraction and decreased LDL, increased lipoprotein lipase activity) are very commonly observed in patients treated with asparaginase, which in most cases present without clinical symptoms.
Pri bolnikih, zdravljenih z asparaginazo, zelo pogosto ugotavljamo blage do zmerne spremembe vrednosti krvnih lipidov (npr. zvišan ali znižan holesterol, zvišani trigliceridi, zvišana frakcija VLDL in znižan LDL, zvečana aktivnost lipoproteinske lipaze), ki so večinoma brez kliničnih simptomov.
After reconstitution 1 ml contains 2,500 units of asparaginase.
Po rekonstituciji 1 ml vsebuje 2.500 enot asparaginaze.