FrancophonIA/ELRC3.0 huggingface dataset:
English: The diluted solution of asparaginase should be infused over 0.5 to 2 hours.
Slovenian: Infundiranje razredčene raztopine asparaginaze mora trajati 0,5 ure do 2 uri.
English: • low blood sugar level (hypoglycaemia)
Slovenian: • nizka raven sladkorja v krvi (hipoglikemija),
English: Dissolution of the contents is achieved by slow turning (avoid froth formation due to shaking).
Slovenian: Vsebino raztopite tako, da vialo počasi obračate (pazite, da ne bo nastala pena zaradi stresanja).
English: 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.
Slovenian: 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.
English: Spectrila is given into a vein.
Slovenian: Zdravilo Spectrila se daje v veno.
English: The recommended intravenous dose of asparaginase is 5,000 units per square metre (U/m²) body surface area (BSA) given every third day.
Slovenian: Priporočeni intravenski odmerek asparaginaze je 5.000 enot na kvadratni meter (E/m²) telesne površine vsak tretji dan.
English: 3,527 (2,231 - 4,526) U/l
Slovenian: 3.527 (2.231-4.526) E/l čas do Cmax
English: Ischaemic stroke, reversible posterior leukoencephalopathy syndrome (RPLS), convulsion, disturbances in consciousness including coma
Slovenian: Občasni glavoboli Redki ishemična možganska kap, sindrom reverzibilne posteriorne levkoencefalopatije (RPLS), konvulzije, motnje zavesti vključno s komo
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1072/001
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/15/1072/001
English: Hypersensitivity reactions range from transient flushing or rash and urticaria to bronchospasm, angioedema and anaphylaxis.
Slovenian: Preobčutljivostne reakcije segajo od prehodnih vročinskih oblivov ali izpuščaja in urtikarije do bronhospazma, angioedema in anafilaksije.
English: 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.
Slovenian: 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.
English: These patients should no longer be treated with any asparaginase preparation (see also sections 4.3 and 4.8).
Slovenian: Ti bolniki se ne smejo več zdraviti z nobenim zdravilom z asparaginazo (glejte tudi poglavji 4.3
English: You should therefore not receive vaccination with live vaccines until at least 3 months after the end of treatment with Spectrila.
Slovenian: Zato se najmanj 3 mesece po končanem zdravljenju z zdravilom Spectrila ne smete cepiti z živimi cepivi.
English: Asparaginase is produced by recombinant DNA technology in a microorganism named Escherichia coli.
Slovenian: DNA v mikroorganizmu, ki se imenuje Escherichia coli.
English: The recommended dose of Spectrila for adults is 5,000 U per m² body surface area (BSA) given every third day.
Slovenian: Priporočeni odmerek zdravila Spectrila za odrasle je 5.000 E na m² telesne površine, ki se daje vsak tretji dan.
English: • seizures, severe impairment of consciousness including coma, and stroke
Slovenian: • epileptični napadi, huda okvara zavesti vključno s komo in možganska kap,
English: • high blood levels of amylase and lipase
Slovenian: • visoka raven amilaze in lipaze v krvi,
English: Asparaginase does not seem to penetrate the blood-brain barrier in measurable amounts.
Slovenian: Zdi se, da asparaginaza ne prehaja v merljivih količinah skozi krvno-možgansko pregrado.
English: 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.
Slovenian: in 33. dan je bila 209 (42 - 330) E/l, 130 (6 - 424) E/l oziroma 32 (1 - 129) E/l.
English: 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.
Slovenian: 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.
English: • accumulation of fluid (oedema)
Slovenian: • kopičenje tekočine (edem),
English: Thrombosis especially cavernous sinus thrombosis or deep vein thrombosis, haemorrhage
Slovenian: Pogosti tromboza, predvsem tromboza kavernoznega sinusa ali globoka venska tromboza, krvavitev
English: LIST OF EXCIPIENTS Excipient: sucrose.
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožna snov: saharoza.
English: Anorexia, loss of appetite, abdominal cramps, diarrhoea and weight loss have also been reported.
Slovenian: Poročali so tudi o anoreksiji, izgubi apetita, trebušnih krčih, driski in hujšanju.
English: • Medicines which are metabolised in the liver, because the risk of side effects may increase.
Slovenian: • Zdravila, ki se presnavljajo v jetrih, ker se lahko zveča tveganje za neželene učinke.
English: Very rare (may affect up to 1 in 10,000 people):
Slovenian: Zelo redki (lahko se pojavijo pri največ 1 od 10.000 bolnikov):
English: Since an indirect interaction between components of the oral contraception and asparaginase cannot be ruled out, oral contraceptives are not considered sufficiently safe.
Slovenian: Ker ni mogoče izključiti posredne interakcije med učinkovinami v peroralnih kontraceptivih in asparaginazo, peroralni kontraceptivi niso dovolj varni.
English: Asparaginase may induce hyperglycaemia as a consequence of decreased insulin production.
Slovenian: Asparaginaza lahko povzroči hiperglikemijo zaradi zmanjšanega nastajanja insulina.
English: Very rare Secondary hypothyroidism, hypoparathyroidism
Slovenian: Bolezni endokrinega sistema Zelo redki sekundarni hipotiroidizem, hipoparatiroidizem
English: • feeling of tiredness
Slovenian: • občutek utrujenosti,
English: 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).
Slovenian: 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).
English: Haemorrhagic pancreatitis, necrotising pancreatitis, parotitis Very rare
Slovenian: Redki hemoragični pankreatitis, nekrozantni pankreatitis, parotitis
English: Increase in amylase, lipase, abnormal electroencephalogram (EEG) (reduced alpha wave activity, increased theta and delta wave activity)
Slovenian: lipoproteina majhne gostote (LDL), celotnih beljakovin Pogosti zvišanje amilaze, lipaze, abnormalen elektroencefalogram (EEG) (zmanjšana aktivnost valov alfa, zvečana aktivnost valov theta in delta)
English: Fertility No human data on the effect of asparaginase on fertility are available.
Slovenian: Ni podatkov o učinku asparaginaze na plodnost pri ljudeh.
English: 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).
Slovenian: Kot posledica ovirane sinteze beljakovin se pri bolnikih, zdravljenih z asparaginazo, zelo pogosto zniža raven serumskih beljakovin (posebno albuminov) (glejte poglavje 4.4).
English: 60,165 (38,627 - 80,764) U*h/l
Slovenian: 60.165 (38.627-80.764) E*h/l največja koncentracija v serumu (Cmax)
English: Allergy and anaphylaxis
Slovenian: Alergija in anafilaksija
English: 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.
Slovenian: Ker ni mogoče izključiti posredne interakcije med učinkovinami v peroralnih kontraceptivih in asparaginazo, peroralni kontraceptivi v taki klinični situaciji niso dovolj varni.
English: 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
Slovenian: 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,
English: • inflammation of the salivary glands (parotitis)
Slovenian: • vnetje slinavk (parotitis),
English: A few cases of asparaginase-induced parotitis have been reported in the literature.
Slovenian: V literaturi so poročali o redkih primerih parotitisa, povzročenega z asparaginazo.
English: • Medicines which may have a negative effect on liver function since these negative effects may be worsened by concomitant treatment with asparaginase.
Slovenian: • Zdravila, ki bi lahko negativno vplivala na delovanje jeter, ker lahko sočasno zdravljenje z asparaginazo poslabša te negativne učinke.
English: 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.
Slovenian: 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.
English: Hans-Knoell-Str. 3
Slovenian: Wacker Biotech GmbH Hans-Knoell-Str. 3 07745 Jena
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).
Slovenian: 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
English: Asparaginase-induced tumour cell destruction may release large amounts of uric acid, resulting in hyperuricaemia.
Slovenian: Ob odmrtju tumorskih celic, ki ga povzroči asparaginaza, se lahko sprosti velika količina sečne kisline, ki povzroči hiperurikemijo.
English: • hyperglycaemic conditions.
Slovenian: • hiperglikemična stanja.
English: Spectrila is for administration by intravenous infusion only.
Slovenian: Zdravilo Spectrila se aplicira samo z intravenskim infundiranjem.
English: Hepatic failure with potentially fatal outcome, hepatic necrosis, cholestasis, jaundice
Slovenian: Redki odpoved jeter z možnim smrtnim izidom, nekroza jeter, holestaza,
English: Pharmacotherapeutic group: Antineoplastic agents; Other antineoplastic agents ATC code: L01XX02
Slovenian: oznaka ATC: L01XX02
English: Hyperglycaemia and hypoglycaemia
Slovenian: Hiperglikemija in hipoglikemija
English: • inflammation of the pancreas, which causes severe pain in the abdomen and back,
Slovenian: • vnetje trebušne slinavke, ki povzroča močne bolečine v trebuhu in križu,
English: No dose adjustment is necessary in patients with mild to moderate hepatic impairment.
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter prilagajanje odmerjanja ni potrebno.
English: Storage would normally not be longer than 24 hours at 2 °C - 8 °C.
Slovenian: Shranjevanje naj bi normalno ne trajalo dalj od 24 ur pri
English: Not known Infections
Slovenian: Infekcijske in parazitske bolezni Neznana okužbe
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA
English: • cholestasis (blocked bile flow from the liver)
Slovenian: • holestaza (oviran odtok žolča iz jeter),
English: • blood clotting disorders such as bleeding, disseminated intravascular coagulation (DIC) or formation of blood clots (thrombosis),
Slovenian: • motnje strjevanja krvi, na primer krvavitev, diseminirana intravaskularna koagulacija (DIK) ali nastajanje krvnih strdkov (tromboza), • visoka raven sladkorja v krvi (hiperglikemija).
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje
English: The ready-to-use solution may exhibit a slight opalescence.
Slovenian: Raztopina, pripravljena za uporabo, je lahko rahlo opalescenčna.
English: Based on limited data, the recommended dose in infants is as follows: - age less than 6 months:
Slovenian: Na podlagi malo podatkov je priporočeni intravenski odmerek pri dojenčkih:
English: Fax: +49-4103-8006-100
Slovenian: Tel.: +49-4103-8006-0 Faks: +49-4103-8006-100
English: 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).
Slovenian: > 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).
English: Cytarabine
Slovenian: Citarabin
English: Uncommon side effects (may affect up to 1 in 100 people):
Slovenian: Občasni neželeni učinki (lahko se pojavijo pri največ 1 od 100 bolnikov):
English: 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).
Slovenian: 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.
English: In rare cases, haemorrhagic or necrotising pancreatitis occurs.
Slovenian: V redkih primerih se pojavi hemoragični ali nekrozantni pankreatitis.
English: • History of pancreatitis, serious haemorrhage or serious thrombosis with prior asparaginase therapy.
Slovenian: • predhodna znana koagulopatija (npr. hemofilija) • Anamneza pankreatitisa, resne krvavitve ali resne tromboze pri predhodnem zdravljenju z asparaginazo.
English: As a consequence of hypoalbuminaemia oedema can occur.
Slovenian: Kot posledica se lahko pojavijo edemi zaradi hipoalbuminemije.
English: Hyperglycaemic conditions
Slovenian: Hiperglikemična stanja
English: Co-administration of other antineoplastic medicinal products contributes to this effect.
Slovenian: Sočasna uporaba drugih zdravil z delovanjem na novotvorbe prispeva k temu učinku.
English: What Spectrila contains
Slovenian: Kaj vsebuje zdravilo Spectrila
English: • decreased function of the thyroid gland or the parathyroid glands
Slovenian: • zmanjšano delovanje ščitnice ali obščitnic,
English: • Pancreatitis.
Slovenian: • pankreatitis
English: No allergic reactions were observed in any of the 12 infants < 1 year of age during treatment with Spectrila (study MC-ASP.6/INF).
Slovenian: Med zdravljenjem z zdravilom Spectrila niso pri nobenem od 12 dojenčkov, mlajših od 1 leta, opazili alergijskih reakcij (študija MC-ASP.6/INF).
English: • pseudocysts of the pancreas (collections of fluid after acute inflammation of the pancreas)
Slovenian: • psevdociste pankreasa (zbiri tekočine po akutnem vnetju trebušne slinavke).
English: 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.
Slovenian: 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.
English: After reconstitution 1 ml contains 2,500 units of asparaginase.
Slovenian: Po rekonstituciji 1 ml vsebuje 2.500 enot asparaginaze.
English: Hypersensitivity including flushing, rash, hypotension, oedema/angioedema, urticaria, dyspnoea Common
Slovenian: Zelo pogosti preobčutljivost, vključno z vročinskimi oblivi, izpuščajem, hipotenzijo, edemi/angioedemom, urtikarijo, dispnejo
English: Before initiating therapy bilirubin, hepatic transaminases and coagulation parameters (e.g. partial thromboplastin time [PTT], prothrombin time [PT], antithrombin III and fibrinogen) should be determined.
Slovenian: Pred uvedbo zdravljenja je treba določiti bilirubin, jetrne transaminaze in koagulacijske parametre (npr. parcialni tromboplastinski čas [PTČ], protrombinski čas [PČ], antitrombin III in fibrinogen).
English: • severe inflammation of the pancreas (acute pancreatitis),
Slovenian: • hudo vnetje trebušne slinavke (akutni pankreatitis),
English: Asparaginase must not be administered as a bolus dose.
Slovenian: Asparaginaze ni dovoljeno dajati v obliki bolusnega odmerka.
English: • destruction of liver cells (liver cell necrosis)
Slovenian: • zlatenica, • odmrtje (nekroza) jetrnih celic,
English: • Medicines which may suppress bone marrow function as these effects may be enhanced by concomitant use of asparaginase.
Slovenian: • Zdravila, ki lahko zavrejo delovanje kostnega mozga, ker lahko sočasna uporaba asparaginaze zveča te učinke.
English: • If you get any side effects, talk to your doctor or nurse.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali medicinsko sestro.
English: In rare cases, a reversible posterior leukoencephalopathy syndrome (RPLS) has been observed during therapy with asparaginase-containing regimens.
Slovenian: V redkih primerih so med zdravljenjem s terapevtskimi shemami, ki vsebujejo asparaginazo, ugotavljali sindrom reverzibilne posteriorne levkoencefalopatije (RPLS).
English: It is usually given with other anti-cancer medicines.
Slovenian: Navadno se daje skupaj z drugimi zdravili z delovanjem na novotvorbe.
English: Hepatic steatosis
Slovenian: Neznana steatoza jeter
English: Similarly to adults, the recommended dose in children and adolescents aged 1 - 18 years is 5,000 U per m² BSA given every third day.
Slovenian: Uporaba pri otrocih in mladostnikih Podobno kot pri odraslih je priporočeni odmerek pri otrocih in mladostnikih, starih 1-18 let, 5.000 E
English: If you get any side effects, talk to your doctor or nurse.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali medicinsko sestro.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Spectrila 10,000 U powder for concentrate for solution for infusion Asparaginase
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Spectrila 10.000 e. prašek za koncentrat za raztopino za infundiranje asparaginaza
English: • Reversible posterior leukoencephalopathy syndrome (a condition characterised by headache,
Slovenian: • sindrom reverzibilne posteriorne levkoencefalopatije (bolezensko stanje, za katerega so značilni glavobol, zmedenost, epileptični napadi in okvara vida),
English: Diarrhoea, nausea, vomiting, abdominal pain Common
Slovenian: Zelo pogosti driska, navzea, bruhanje, bolečine v trebuhu
English: Anaphylactic shock
Slovenian: Redki anafilaktični šok
English: The following life-threatening situations could arise during treatment with Spectrila:
Slovenian: Med zdravljenjem z zdravilom Spectrila lahko nastanejo naslednji smrtno nevarni zapleti:
English: Sinus vein thrombosis can occur.
Slovenian: Lahko se pojavi tromboza venskih sinusov.
English: The active substance is asparaginase.
Slovenian: • Zdravilna učinkovina je asparaginaza.
English: medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM medac Gesellschaft für klinische Spezialpräparate mbH
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.
Slovenian: 55 let, navadno slabše prenašajo zdravljenje z asparaginazo kot pediatrični bolniki.
English: Headaches
Slovenian: Dojenje
English: Glucocorticoids
Slovenian: Glukokortikoidi
English: Name and address of the manufacturer of the biological active substance Wacker Biotech GmbH
Slovenian: Ime in naslov izdelovalca biološke zdravilne učinkovine
English: After administration of asparaginase, close monitoring of bilirubin, hepatic transaminases, of blood/urinary glucose, coagulation parameters (PTT, PT, antithrombin III, fibrinogen, and D-dimer), amylase, lipase, triglycerides, and cholesterol is recommended.
Slovenian: Po uporabi asparaginaze je priporočljivo skrbno spremljanje bilirubina, jetrnih transaminaz, glukoze v krvi in urinu, koagulacijskih parametrov (PTČ, PČ, antitrombin III, fibrinogen in D-dimer), amilaze,
English: 4 years
Slovenian: Neodprte viale 4 leta
English: • pain (back pain, joint pain, stomach ache)
Slovenian: • bolečine (v križu, sklepih, trebuhu).
English: • high blood levels of ammonia (hyperammonaemia)
Slovenian: • visoka raven amoniaka v krvi (hiperamonemija), • glavobol.
English: Hypoglycaemia mostly without clinical symptoms has been commonly observed in patients treated with asparaginase.
Slovenian: Pri bolnikih, zdravljenih z asparaginazo, so pogosto opazili hipoglikemijo, navadno brez kliničnih simptomov.
English: Therefore, caution should be exercised in patients receiving other medicines metabolised by the liver.
Slovenian: ki prejemajo druga zdravila, ki jih presnavljajo jetra.
English: No anti-asparaginase antibodies were detected in any of the 12 infants < 1 year of age during treatment with Spectrila (study MC-ASP.6/INF).
Slovenian: Pri nobenem od 12 dojenčkov, mlajših od 1 leta, niso med zdravljenjem z zdravilom Spectrila zaznali antiasparaginaznih protiteles (študija MC-ASP.6/INF).
English: • high blood levels of uric acid (hyperuricaemia)
Slovenian: • visoka raven sečne kisline v krvi (hiperurikemija),
English: Renal impairment No dose adjustment is necessary in patients with renal impairment.
Slovenian: Okvara ledvic Pri bolnikih z okvaro ledvic prilagajanje odmerjanja ni potrebno.
English: The calculated quantity of asparaginase is dissolved further in 50 to 250 ml of sodium chloride 9 mg/ml (0.9 %) solution for infusion.
Slovenian: 50-250 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje.
English: A method other than oral contraceptives should be used in women of childbearing potential.
Slovenian: Ženske v rodni dobi morajo uporabljati drugo metodo, ne peroralnih kontraceptivov.
English: What Spectrila looks like and contents of the pack Spectrila is provided as a powder for concentrate for solution for infusion.
Slovenian: Zdravilo Spectrila je na voljo kot prašek za koncentrat za raztopino za infundiranje.
English: Fax: +49 4103 8006-100
Slovenian: Tel.: +49 4103 8006-0 Faks: +49 4103 8006-100 E-pošta: contact@medac.de
English: After reconstitution, one ml contains 2,500 units of asparaginase.
Slovenian: Po rekonstituciji vsebuje en ml 2,500 enot asparaginaze.