FrancophonIA/ELRC3.0 huggingface dataset:
English: As a result of asparaginase-induced asparagine depletion in serum, protein synthesis in lymphoblastic tumour cells is disturbed while sparing most normal cells.
Croatian: Kao rezultat deplecije asparagina u serumu izazvane asparaginazom, poremećena je sinteza proteina u limfoblastičnim tumorskim stanicama, dok većina normalnih stanica ostane pošteđena.
English: You should therefore not receive vaccination with live vaccines until at least 3 months after the end of treatment with Spectrila.
Croatian: Stoga ne smijete biti cijepljeni živim cjepivom najmanje 3 mjeseca nakon završetka liječenja Spectrilom.
English: • 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).
Croatian: • Glukokortikoidi (protuupalni lijekovi koji smanjuju odgovor imunosnog sustava) jer istovremena primjena glukokortikoida i asparaginaze može povećati stvaranje krvnih ugrušaka (tromboza).
English: Due to the inhibition of protein synthesis (decreased synthesis of factors II, V, VII, VIII, and IX, proteins C and S, antithrombin III [AT III]) caused by asparaginase, coagulation disorders can occur which can manifest either as thrombosis, disseminated intravascular coagulation (DIC), or bleeding.
Croatian: Zbog inhibicije sinteze proteina (smanjena sinteza faktora II, V, VII, VIII i IX, proteina C i S, antitrombina III [AT III]) prouzročene asparaginazom, mogu se pojaviti poremećaji koagulacije koji se mogu očitovati ili kao tromboza, diseminirana intravaskularna koagulacija (DIK) ili krvarenje.
English: Immunisation with live vaccines should therefore take place at the earliest 3 months after completion of the course of antileukaemic treatment.
Croatian: Stoga se imunizaciju živim cjepivima smije provoditi nakon najmanje 3 mjeseca od završenog ciklusa terapije protiv leukemije.
English: In rare cases, diabetic ketoacidosis has been reported.
Croatian: U rijetkim slučajevima zabilježena je dijabetička ketoacidoza.
English: • If you have any further questions, ask your doctor or nurse.
Croatian: • Ako imate dodatnih pitanja, obratite se liječniku ili medicinskoj sestri.
English: 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.
Croatian: Zabilježeni su slučajevi tranzitorne sekundarne hipotireoze vjerojatno prouzročene smanjenjem serumskog globulina koji veže tiroksin, zbog inhibicije sinteze proteina prouzročene asparaginazom.
English: Complete remission rate at end of induction treatment Yes
Croatian: Stopa potpune remisije na kraju indukcijskog liječenja
English: 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.
Croatian: Prašak je bijele boje, a isporučuje se u bočicama od prozirnog stakla s gumenim čepom i nepropusnim zatvaračem od aluminija te plastičnim poklopcem.
English: 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).
Croatian: U kliničkim ispitivanjima s asparaginazom, najniže aktivnosti asparaginaze u serumu veće od 100 U/l bile su postignute u većine bolesnika što je gotovo uvijek koreliralo s potpunom deplecijom asparagina u serumu i cerebrospinalnoj tekućini.
English: • depression, hallucination or confusion
Croatian: • depresija, halucinacije ili smetenost (konfuzija)
English: • feeling of tiredness
Croatian: • osjećaj umora
English: Anorexia, loss of appetite, abdominal cramps, diarrhoea and weight loss have also been reported.
Croatian: Zabilježene su također anoreksija, gubitak apetita, grčevi u abdomenu, proljev i gubitak težine.
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Croatian: Unutar svake skupine nuspojave su navedene slijedom od veće prema manjoj ozbiljnosti.
English: EU/1/15/1072/002 (5 vials)
Croatian: EU/1/15/1072/002 (5 bočica)
English: How to store Spectrila
Croatian: Kako primjenjivati Spectrilu
English: Dissolution of the contents is achieved by slow turning (avoid froth formation due to shaking).
Croatian: Otapanje sadržaja postiže se polaganim okretanjem (izbjeći stvaranje mjehurića zbog tresenja).
English: The diluted solution of asparaginase should be infused over 0.5 to 2 hours.
Croatian: Infuziju razrijeđene otopine asparaginaze treba davati u trajanju od 0,5 do 2 sata.
English: Asparaginase may induce hyperglycaemia as a consequence of decreased insulin production.
Croatian: Asparaginaza može prouzročiti hiperglikemiju kao posljedicu smanjene proizvodnje inzulina.
English: • inflammation of the pancreas, which causes severe pain in the abdomen and back,
Croatian: • upala gušterače, koja uzrokuje jaki bol u trbuhu i leđima
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
Croatian: Veći rizik od razvoja tromboze za vrijeme indukcijskog liječenja asparaginazom i prednizonom zabilježen je u djece s genetskim protrombotskim čimbenikom rizika (mutacije faktora V G1691A,
English: In rare cases, haemorrhagic or necrotising pancreatitis occurs.
Croatian: U rijetkim slučajevima razvije se hemoragijski ili nekrotizirajući pankreatitis.
English: Concomitant administration of glucocorticoids may be a contributing factor.
Croatian: Istovremena primjena glukokortikoida može biti čimbenik koji tome pridonosi.
English: In the study in children/adolescents aged 1 - 18 years with de novo ALL (study MC-ASP.5/ALL), by day 33 of induction treatment 10 patients in the Spectrila group (10.3 %) and 9 in the reference group (8.9 %) were measured positive for anti-asparaginase antibodies at least at one time point.
Croatian: MC-ASP.5/ALL), do 33. dana indukcijskog liječenja ustanovljeno je da je 10 bolesnika u skupini koja je primala Spectrilu (10,3%), a 9 u referentnoj skupini (8,9%) bilo pozitivno na protutijela protiv asparaginaze u najmanje jednoj vremenskoj točki.
English: If severe liver problems occur, treatment with Spectrila must be interrupted immediately.
Croatian: Ako se pojave teške tegobe s jetrom, liječenje Spectrilom treba odmah privremeno prekinuti.
English: Ischaemic stroke, reversible posterior leukoencephalopathy syndrome (RPLS), convulsion, disturbances in consciousness including coma
Croatian: Rijetko ishemijski moždani udar, sindrom reverzibilne posteriorne leukoencefalopatije (RPLS), konvulzije, poremećaji svijesti uključujući komu
English: Asparaginase-induced tumour cell destruction may release large amounts of uric acid, resulting in hyperuricaemia.
Croatian: Uništenje tumorskih stanica potaknuto asparaginazom može osloboditi velike količine uratne (mokraćne) kiseline, što dovodi do hiperuricemije.
English: 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.
Croatian: U slučaju hiperamonemije s teškim kliničkim simptomima, potrebno je započeti s terapijskim i farmakološkim mjerama koje brzo snižavaju razine amonijaka u plazmi (npr. ograničeni unos proteina i hemodijaliza), reverzibilno utječu na katabolička stanja i povećavaju uklanjanje otpadnih dušikovih spojeva te zatražiti stručni savjet.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI
English: *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
Croatian: *Uključujući sve alergijske reakcije koje se pojave unutar 12 sati od infuzije asparaginaze i sve štetne događaje s pojavom sinkope (nesvjestice), hipotenzije, osipa, navale vrućine, pruritusa, dispneje, reakcije na mjestu primjene infuzije i opstrukcije dišnih puteva prema zajedničkim kriterijima terminologije za nuspojave (CTCAE), unutar 24 sata od infuzije asparaginaze.
English: Very rare
Croatian: Vrlo rijetko tremor
English: Even those few patients with trough asparaginase serum activity levels of 10 - 100 U/l usually experienced complete asparagine depletion in serum and CSF.
Croatian: Čak i onaj mali broj bolesnika s najnižim razinama aktivnosti asparaginaze u serumu od 10 do 100 U/l obično je imao potpunu depleciju asparagina u serumu i cerebrospinalnoj tekućini.
English: The diluted solution of asparaginase may be infused over 0.5 to 2 hours.
Croatian: Infuzija razrijeđene otopine asparaginaze može se davati u trajanju od 0,5 do 2 sata.
English: Pancreatitis with fatal outcome, pancreatic pseudocyst
Croatian: Vrlo rijetko pankreatitis sa smrtnim ishodom, pseudocista pankreasa
English: • Severe hepatic impairment (bilirubin > 3 times upper limit of normal [ULN]; transaminases
Croatian: • teško oštećenje funkcije jetre (bilirubin > 3 puta iznad gornje granice normale [GGN];
English: Coagulation disorders
Croatian: Poremećaji koagulacije
English: Reversible posterior leukoencephalopathy syndrome Reversible posterior leukoencephalopathy syndrome (RPLS) may occur rarely during treatment with any asparaginase (see section 4.8).
Croatian: Sindrom reverzibilne posteriorne leukoencefalopatije Sindrom reverzibilne posteriorne leukoencefalopatije (RPLS) može se u rijetkim slučajevima pojaviti tijekom liječenja bilo kojom asparaginazom (vidjeti dio 4.8).
English: Low asparaginase activity levels are often accompanied by the appearance of anti-asparaginase antibodies.
Croatian: Niske razine aktivnosti asparaginaze često su popraćene pojavom protutijela protiv asparaginaze.
English: • Pre-existing known coagulopathy (e.g. haemophilia).
Croatian: • prethodno postojeća poznata koagulopatija (npr. hemofilija)
English: Median (range) maximum serum concentrations of asparaginase activity were 2,324 U/l (1,6254,819 U/l).
Croatian: Medijan (raspon) maksimalnih koncentracija aktivnosti asparaginaze u serumu iznosio je 2324 U/l (1625 - 4819 U/l).
English: A comparable proportion of patients in both groups developed anti-asparaginase antibodies before the start of the post-induction treatment phase (Spectrila 54.6 % vs. reference E. coli-asparaginase 52.5 %).
Croatian: U obje skupine sličan udio bolesnika razvio je protutijela protiv asparaginaze prije početka faze postindukcijskog liječenja (54,6% u skupini koja je primala Spectrilu naspram 52,5% u skupini koja je primala referentnu asparaginazu dobivenu iz E. coli).
English: Hyperammonaemia has been reported uncommonly in patients treated with asparaginase-containing therapy protocols, especially if patients suffer additionally from hepatic impairment.
Croatian: Hiperamonijemija je manje često zabilježena u bolesnika liječenih protokolima koji uključuju asparaginazu, osobito u bolesnika koji dodatno imaju oštećenje funkcije jetre.
English: • seizures, severe impairment of consciousness including coma, and stroke
Croatian: • napadaji, teško oštećenje svijesti uključujući komu, i moždani udar
English: 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
Croatian: U nekontroliranom kliničkom ispitivanju (ispitivanje MC-ASP.6/INF) 12 dojenčadi s de novo ALL-om (medijan dobi [raspon] u trenutku prve infuzije: 6 mjeseci [0,5 - 12,2 mjeseca]) bilo je liječeno Spectrilom u okviru protokola INTERFANT-06.
English: • inflammation of the salivary glands (parotitis)
Croatian: • upala žlijezda slinovnica (parotitis)
English: To aid traceability of rASNase batches and distinction between different ASNase and rASNase products, the product information should include in section 4.4 of the SmPC and relevant section of the PL a prominent statement that the name and batch number of the administered product should be clearly recorded in the patient records.
Croatian: Kako bi se pridonijelo sljedivosti serija lijekova koji sadrže rekombinantnu asparaginazu te razlikovanju između lijekova koji sadrže asparaginazu i lijekova koji sadrže rekombinantnu asparaginazu, informacije o lijeku u dijelu 4.4. sažetka opisa svojstava lijeka i odgovarajućem dijelu upute o lijeku moraju sadržavati istaknut navod o tome da je naziv i seriju primijenjenog lijeka potrebno jasno evidentirati u zdravstvenom kartonu bolesnika.
English: • severe liver function abnormalities (determined by laboratory tests),
Croatian: • velika odstupanja od normalnih vrijednosti u pretragama funkcije jetre (ustanovljena laboratorijskim testovima)
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).
Croatian: Veći rizik od razvoja tromboze za vrijeme indukcijskog liječenja asparaginazom i prednizonom zabilježen je u djece s genetskim protrombotskim čimbenikom rizika (mutacije faktora V G1691A, varijacija gena za protrombin G20210A, metilentetrahidrofolat reduktaza [MTHFR] genotip T677T, povećani lipoprotein A, hiperhomocisteinemija).
English: Antineoplastic agents
Croatian: Antineoplastični lijekovi
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.
Croatian: Smanjena sinteza proteina može pretežno dovesti do oštećenja funkcije jetre, akutnog pankreatitisa, smanjene proizvodnje inzulina s hiperglikemijom, smanjene proizvodnje faktora koagulacije (osobito fibrinogena i antitrombina III) što dovodi do poremećaja koagulacije (tromboze, krvarenja) te do smanjene proizvodnje lipoproteina što rezultira hipertrigliceridemijom.
English: Measurement of the asparaginase activity level in serum or plasma may be undertaken in order to rule out accelerated elimination of asparaginase activity.
Croatian: Mjerenje razine aktivnosti asparaginaze u serumu ili plazmi može se provesti kako bi se isključila ubrzana eliminacija aktivnosti asparaginaze.
English: 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).
Croatian: Najčešće (vrlo često) opažene nuspojave Spectrile uključuju reakcije preosjetljivosti, hiperglikemiju, hipoalbuminemiju, mučninu, povraćanje, proljev, bol u abdomenu, edem, umor i promjenu laboratorijskih parametara (npr. transaminaza, bilirubina, lipida u krvi, parametara koagulacije).
English: Name and address of the manufacturer(s) responsible for batch release medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: The reconstituted solution may exhibit a slight opalescence.
Croatian: Rekonstituirana otopina može biti blago opalescentna.
English: 6,700 U/m² BSA,
Croatian: 6700 U/m² tjelesne površine
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).
Croatian: Liječenje asparaginazom treba privremeno prekinuti ako bolesnici razviju teško oštećenje funkcije jetre (bilirubin > 3 puta iznad GGN-a; transaminaze > 10 puta iznad GGN-a), tešku hipertrigliceridemiju, hiperglikemiju ili poremećaj koagulacije (npr. trombozu venskih sinusa, teško krvarenje).
English: • accumulation of fluid (oedema)
Croatian: • nakupljanje tekućine (edem)
English: Measurement of the asparaginase activity level in serum or plasma may be undertaken in order to rule out accelerated reduction of asparaginase activity.
Croatian: Mjerenje razine aktivnosti asparaginaze u serumu ili plazmi može se provesti kako bi se isključilo ubrzano smanjenje aktivnosti asparaginaze.
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.
Croatian: Alergijske reakcije mogu se manifestirati kao navale vrućine, osip, bol (bol u zglobovima, bol u leđima i bol u abdomenu), hipotenzija, edem/angioedem, urtikarija, dispneja, bronhospazam pa sve do anafilaktičkog šoka.
English: 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.
Croatian: Pokazalo se da inhibicija sinteze proteina uslijed deplecije asparagina izazvane asparaginazom oslabljuje citotoksični učinak metotreksata koji za svoje antineoplastično djelovanje zahtijeva umnožavanje stanica.
English: Study in infants with de novo ALL
Croatian: Ispitivanje u dojenčadi s de novo ALL-om
English: As a consequence of hypoalbuminaemia oedema can occur.
Croatian: Kao posljedica hipoalbuminemije može se razviti edem.
English: The recommended intravenous dose of asparaginase is 5,000 units per square metre (U/m²) body surface area (BSA) given every third day.
Croatian: Preporučena intravenska doza asparaginaze iznosi 5000 jedinica po četvornom metru (U/m²) tjelesne površine (BSA), a daje se svaki treći dan.
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).
Croatian: Najozbiljnije nuspojave primjene Spectrile uključuju teške reakcije preosjetljivosti, kao što su anafilaktički šok (rijetko), tromboembolijski događaji (često), akutni pankreatitis (često) i teška hepatotoksičnost, npr. žutica, hepatička nekroza, zatajenje jetre (rijetko).
English: 7,500 U/m² BSA.
Croatian: 7500 U/m² tjelesne površine
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
Croatian: Vrlo često povećanje transaminaza, bilirubina u krvi, alkalne fosfataze u krvi, kolesterola u krvi, triglicerida u krvi, lipoproteina vrlo niske gustoće (VLDL), aktivnosti lipoproteinske lipaze, ureje u krvi, amonijaka, laktat dehidrogenaze u krvi (LDH), smanjenje antitrombina III, fibrinogena u krvi, kolesterola u krvi, lipoproteina niske gustoće (LDL), ukupnih proteina
English: • cholestasis (blocked bile flow from the liver)
Croatian: • kolestaza (zapriječen protok žuči iz jetre)
English: How to use Spectrila
Croatian: Kako čuvati Spectrilu
English: • decreased function of the thyroid gland or the parathyroid glands
Croatian: • smanjena funkcija štitne žlijezde i doštitnih žlijezda
English: • pseudocysts of the pancreas (collections of fluid after acute inflammation of the pancreas)
Croatian: • pseudociste gušterače (nakupljanje tekućine nakon akutne upale gušterače)
English: Fertility No human data on the effect of asparaginase on fertility are available.
Croatian: Nisu dostupni podaci o učinku asparaginaze na plodnost u ljudi.
English: One vial contains 10,000 units of asparaginase.
Croatian: Jedna bočica sadrži 10 000 jedinica asparaginaze.
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).
Croatian: Kao posljedica oštećene sinteze proteina, u bolesnika liječenih asparaginazom vrlo se često smanjuje razina proteina u serumu (osobito albumina) (vidjeti dio 4.4).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1072/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1072/001
English: Serum and urine glucose levels should be regularly monitored and managed as clinically indicated.
Croatian: Potrebno je redovito pratiti razine glukoze u serumu i mokraći i to zbrinjavati kako je klinički indicirano.
English: A few cases of asparaginase-induced parotitis have been reported in the literature.
Croatian: U literaturi je zabilježeno nekoliko slučajeva parotitisa izazvanih asparaginazom.
English: Hepatic failure with potentially fatal outcome, hepatic necrosis, cholestasis, jaundice
Croatian: Rijetko zatajenje jetre s mogućim smrtnim ishodom, hepatička nekroza, kolestaza, žutica
English: • hyperglycaemic conditions.
Croatian: • hiperglikemijska stanja.
English: Hypersensitivity reactions range from transient flushing or rash and urticaria to bronchospasm, angioedema and anaphylaxis.
Croatian: Reakcije preosjetljivosti kreću se u rasponu od prolaznih navala vrućina ili osipa i urtikarije do bronhospazma, angioedema i anafilaksije.
English: Patients received asparaginase at a dose of 10,000 U/m², adjusted to the current age of the patient at the time of administration (< 6 months: 6,700 U/m²; 6 - 12 months: 7,500 U/m²; > 12 months: 10,000 U/m²) on days 15, 18, 22, 25, 29, and 33 of induction treatment.
Croatian: Bolesnici su 15., 18., 22., 25., 29. i 33. dana indukcijskog liječenja primili asparaginazu u dozi od 10 000 U/m², prilagođenu dobi bolesnika u trenutku primjene (< 6 mjeseci: 6700 U/m²; 6 - 12 mjeseci: 7500 U/m²; > 12 mjeseci: 10 000 U/m²).
English: • Medicines which may suppress bone marrow function as these effects may be enhanced by concomitant use of asparaginase.
Croatian: • Lijekovi koji mogu potisnuti funkciju koštane srži jer ti učinci mogu biti povećani istovremenom primjenom asparaginaze.
English: Reversible posterior leukoencephalopathy syndrome Reversible posterior leukoencephalopathy syndrome (RPLS) may occur rarely during treatment with any asparaginase.
Croatian: Sindrom reverzibilne posteriorne leukoencefalopatije Sindrom reverzibilne posteriorne leukoencefalopatije (RPLS) može se u rijetkim slučajevima pojaviti tijekom liječenja bilo kojom asparaginazom.
English: The time period following treatment with asparaginase when it is safe to become pregnant or father a child is unknown.
Croatian: Nije poznato poslije koliko vremena je sigurno zatrudnjeti ili začeti dijete nakon liječenja asparaginazom.
English: Trough serum activity levels were measured in 12 infants (age from birth to 1 year) with de novo ALL (study MC-ASP.6/INF).
Croatian: Najniže razine aktivnosti u serumu izmjerene su u 12 djece (u dobi od rođenja do 1 godine) s de novo ALL-om (ispitivanje MC-ASP.6/INF).
English: • severe inflammation of the pancreas (acute pancreatitis),
Croatian: • teška upala gušterače (akutni pankreatitis),
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 (see section 4.6).
Croatian: Budući da se neizravna interakcija između sastojaka oralne kontracepcije i asparaganaze ne može isključiti, oralna kontracepcija ne smatra se dovoljno pouzdanom u takvoj kliničkoj situaciji (vidjeti dio 4.6).
English: • high blood levels of amylase and lipase
Croatian: • visoke razine amilaze i lipaze u krvi