FrancophonIA/ELRC3.0 huggingface dataset:
English: All 12 patients (100 %) were in CR after induction treatment.
Slovenian: Vseh 12 bolnikov (100 %) je bilo po indukcijskem zdravljenju v popolni remisiji.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Preden vam dajo to zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: The duration of treatment depends on the specific chemotherapy protocol that is used to treat your disease.
Slovenian: Trajanje zdravljenja je odvisno od posebnega kemoterapevtskega protokola, ki se uporablja za zdravljenje vaše bolezni.
English: The risk of thrombosis seems to be higher than the risk of bleeding.
Slovenian: Zdi se, da je nevarnost tromboze večja kot nevarnost krvavitve.
English: The syndrome is generally self-limiting.
Slovenian: Sindrom je navadno samoomejujoč.
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po rekonstituciji in razredčenju zdravila glejte poglavje 6.3.
English: • if you are allergic to asparaginase or to any of the other ingredients of this medicine (listed in section 6),
Slovenian: • če ste alergični na asparaginazo ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: Since serum protein is important for the binding and transport function of some active substances, the serum protein level should be monitored regularly.
Slovenian: Ker so serumske beljakovine pomembne za funkcijo vezave in transporta nekaterih zdravilnih učinkovin, je treba redno spremljati raven serumskih beljakovin.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Tell your doctor immediately and stop taking Spectrila if you experience:
Slovenian: Takoj obvestite zdravnika in prenehajte jemati zdravilo Spectrila, če se pojavijo:
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Slovenian: Pogostnosti v tej preglednici so opredeljene z naslednjim dogovorom: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Thereafter, asparagine serum levels increased again and returned to normal values within 1 - 3 weeks.
Slovenian: Nato se je raven serumskega asparagina spet zviševala in dosegla normalne vrednosti po 1-3 tednih.
English: Adults and other special populations
Slovenian: Odrasli in druge posebne skupine bolnikov
English: CI = confidence interval; CSF = cerebrospinal fluid; MRD = minimal residual disease a
Slovenian: CI = interval zaupanja; CSF = cerebrospinalna tekočina; MRD = minimalna rezidualna bolezen a
English: Plasma ammonia levels should be determined in all patients with unexplained neurologic symptoms or severe and prolonged vomiting.
Slovenian: Koncentracijo amoniaka v plazmi je treba določiti pri vseh bolnikih z nepojasnjenimi nevrološkimi simptomi ali hudim in dolgotrajnim bruhanjem.
English: Therefore, they require asparagine which diffuses from the extracellular environment.
Slovenian: Zato potrebujejo asparagin, ki difundira iz zunajceličnega okolja.
English: Increased blood sugar values may require treatment with intravenous fluids and/or insulin.
Slovenian: Pri zvečanih vrednostih krvnega sladkorja bo morda potrebno zdravljenje z intravenskimi tekočinami in/ali insulinom.
English: There have been isolated reports of fatal outcomes.
Slovenian: Obstajajo posamezna poročila o smrtnih izidih.
English: Spectrila will not be used:
Slovenian: Zdravilo Spectrila se ne sme uporabiti:
English: However, treatment with other chemotherapeutic agents should also be taken into consideration.
Slovenian: Vendar pa je treba razmisliti tudi o zdravljenju z drugimi kemoterapevtiki.
English: Very common Oedema, fatigue
Slovenian: Zelo pogosti edem, utrujenost
English: What you need to know before you are given Spectrila
Slovenian: Kaj morate vedeti, preden vam bodo dali zdravilo Spectrila
English: • The medicine also contains sucrose.
Slovenian: • Zdravilo vsebuje tudi saharozo.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če se zdravilo ne uporabi takoj, je za trajanje shranjevanja med uporabo in razmere shranjevanja pred uporabo odgovoren uporabnik, shranjevanje pa naj bi normalno ne trajalo dalj od 24 ur pri 2 °C - 8 °C, razen če sta bila rekonstitucija in razredčenje opravljena v kontroliranih in validirano aseptičnih razmerah.
English: - age 6 - 12 months:
Slovenian: - starih 6-12 mesecev:
English: Table 4: Pharmacokinetic parameters of Spectrila in 14 children/adolescents
Slovenian: Preglednica 4: Farmakokinetični parametri zdravila Spectrila pri 14 otrocih/mladostnikih
English: If the medicine is not used immediately, the user preparing this medicine is responsible for storage times and conditions to ensure sterility of the product.
Slovenian: Če se zdravilo ne uporabi takoj, je za trajanje shranjevanja in razmere, s katerimi se zagotavlja sterilnost zdravila, odgovoren uporabnik, ki pripravlja to zdravilo.
English: The dose depends on your body surface area (BSA) which is calculated from your height and weight.
Slovenian: Odmerek bo odvisen od velikosti vaše telesne površine, ki se izračuna iz vaše višine in telesne mase.
English: Store in a refrigerator (2 °C - 8 °C).
Slovenian: Shranjujte v hladilniku (2 °C-8 °C).
English: It is unclear whether the RPLS is caused by asparaginase, concomitant treatment or the underlying diseases.
Slovenian: Ni jasno, ali RPLS povzročajo asparaginaza, sočasno zdravljenje ali osnovne bolezni.
English: Before and during treatment with Spectrila your doctor will carry out blood tests.
Slovenian: Pred zdravljenjem z zdravilom Spectrila in med njim vam bo zdravnik naredil krvne preiskave.
English: This is important as Spectrila may increase the side effects of other medicines through its effect on the liver which plays an important role in removing medicines from the body.
Slovenian: To je pomembno, ker zdravilo Spectrila lahko zveča neželene učinke drugih zdravil preko svojega vpliva na delovanje jeter, ki ima pomembno vlogo pri odstranjevanju zdravil iz telesa.
English: • increased blood sugar values.
Slovenian: • zvečane vrednosti krvnega sladkorja.
English: Asparaginase may also be toxic to normal cells that divide rapidly and are dependent to some degree on exogenous asparagine supply.
Slovenian: Asparaginaza je lahko toksična tudi za normalne celice, ki se hitro delijo in so do neke mere odvisne od eksogene preskrbe z asparaginom.
English: The time period following treatment with asparaginase when it is safe to become pregnant or father a child is unknown.
Slovenian: Časovno obdobje po zdravljenju z asparaginazo, po katerem postane varno zanositi ali spočeti otroka, ni znano.
English: Driving and using machines Do not drive when taking this medicine because it may make you feel drowsy, tired or confused.
Slovenian: Ko jemljete to zdravilo, ne upravljajte motornih vozil, ker boste lahko zaradi zdravila zaspani, utrujeni ali zmedeni.
English: Rare Diabetic ketoacidosis
Slovenian: Redki diabetična ketoacidoza
English: If you were given more Spectrila than you should If you think that you received too much Spectrila, tell your doctor or nurse as soon as possible.
Slovenian: Če ste prejeli večji odmerek zdravila Spectrila, kot bi smeli Če mislite, da so vam dali preveč zdravila Spectrila, to čim prej povejte zdravniku ali medicinski sestri.
English: Spectrila should only be used by physicians who are experienced in such treatment protocols.
Slovenian: Zdravilo Spectrila smejo uporabljati le zdravniki, ki imajo izkušnje s tovrstnimi protokoli zdravljenja.
English: • if you have or previously had inflammation of the pancreas (pancreatitis),
Slovenian: • če imate ali ste kdaj prej imeli vnetje trebušne slinavke (pankreatitis),
English: Expert advice should first be sought.
Slovenian: Najprej je treba poiskati nasvet specialista.
English: Adverse reactions are ranked under headings of frequency, the most frequent first.
Slovenian: Neželeni učinki so razvrščeni po pogostnosti, najprej najpogostejši.
English: Each pack contains either 1 or 5 vials.
Slovenian: Eno pakiranje vsebuje 1 ali 5 vial.
English: Glucocorticoids and/ or anticoagulants
Slovenian: Glukokortikoidi in/ali antikoagulanti
English: The probability of the occurrence of allergic reactions increases with the number of administered doses; however, in very rare cases reactions can occur at the first dose of asparaginase.
Slovenian: Verjetnost pojavljanja alergijskih reakcij se zvečuje s številom danih odmerkov, vendar se lahko v zelo redkih primerih reakcije pojavijo že pri prvem odmerku asparaginaze.
English: What Spectrila is and what it is used for
Slovenian: Kaj je zdravilo Spectrila in za kaj ga uporabljamo
English: • liver failure which may lead to death
Slovenian: • odpoved jeter, ki lahko povzroči smrt.
English: Intravenous use after further dilution.
Slovenian: Intravenska uporaba po nadaljnjem razredčenju.
English: A list of all other side effects is set out below according to how common they are: Very common side effects (may affect more than 1 in 10 people):
Slovenian: Seznam vseh drugih neželenih učinkov je naveden spodaj glede na to, kako pogosti so: Zelo pogosti neželeni učinki (lahko se pojavijo pri več kot 1 od 10 bolnikov):
English: The lower median activity level on day 33 compared to the former two measurements was in part due to the fact that this last serum sample was taken 4 days after the last infusion of asparaginase instead of three days on the other occasions.
Slovenian: Do manjše ravni mediane aktivnosti na 33. dan kot pri prejšnjih dveh meritvah je prišlo deloma zato, ker je bil zadnji vzorec seruma odvzet 4 dni po zadnji infuziji asparaginaze namesto 3 dni po njej kot v drugih primerih.
English: • changes in the electroencephalogram (a trace of the electrical activity of your brain)
Slovenian: • spremembe v elektroencefalogramu (posnetek električne aktivnosti vaših možganov),
English: Additionally, the urinary pH value and the relative weight of kidneys were increased at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Slovenian: Poleg tega sta se vrednost pH urina in relativna masa ledvic zvečali pri izpostavljenostih, za katere menimo, da dovolj presegajo največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
English: These antibodies may induce clinical allergic reactions, inactivate the enzymatic activity or accelerate the elimination of asparaginase.
Slovenian: Ta protitelesa lahko sprožijo klinične alergijske reakcije, inaktivirajo encimsko aktivnost ali pospešijo izločanje asparaginaze.
English: Spectrila is prepared and given by healthcare personnel.
Slovenian: Zdravilo Spectrila pripravljajo in dajejo zdravstveni delavci.
English: Asparaginase is distributed mainly within the intravascular space.
Slovenian: Asparaginaza se porazdeli v glavnem znotraj intravaskularnega prostora.
English: 5 vials
Slovenian: 1 viala 5 vial
English: Other medicines and Spectrila
Slovenian: Druga zdravila in zdravilo Spectrila
English: Since Spectrila is usually used in combination therapy with other antineoplastic agents, the demarcation from undesirable effects of other medicinal products is often difficult.
Slovenian: Ker se zdravilo Spectrila navadno uporablja v kombinirani terapiji z drugimi zdravili z delovanjem na novotvorbe, je razmejitev od neželenih učinkov drugih zdravil pogosto težavna.
English: The majority of anti-asparaginase antibodies developed in the time gap between the last asparaginase infusion on day 33 and start of post-induction treatment at day 79.
Slovenian: Večina antiasparaginaznih protiteles se je razvila v časovnem intervalu med zadnjo infuzijo asparaginaze 33. dne in začetkom postindukcijskega zdravljenja 79. dne.
English: *Produced in Escherichia coli cells by recombinant DNA technology.
Slovenian: *Izdelane v celicah Escherichia coli s tehnologijo rekombinantne DNA.
English: • mild to moderate reduction in all blood cell counts
Slovenian: • blago do zmerno zmanjšanje števila vseh vrst krvničk,
English: Most hypersensitivity reactions to asparaginase are observed during subsequent treatment phases (reinduction treatment, delayed intensification).
Slovenian: Največ preobčutljivostnih reakcij na asparaginazo ugotavljajo med poznejšimi fazami zdravljenja (reindukcijsko zdravljenje, odložena intenzifikacija).
English: • diabetic ketoacidosis (complication due to uncontrolled blood sugar)
Slovenian: • diabetična ketoacidoza (zaplet zaradi nenadzorovanega krvnega sladkorja),
English: Therefore, vincristine should be given 3 to 24 hours before administration of asparaginase in order to minimise toxicity.
Slovenian: Zato je treba vinkristin dati 3 do 24 ur pred dajanjem asparaginaze, da se toksičnost čim bolj zmanjša.
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.
Slovenian: Za namenom ohranjanja sledljivosti serij rASNaze in za razlikovanje med zdravili z različnimi ASNazami in rASNazami mora biti v informacijah o zdravilu v poglavju 4.4 SmPC-ja in ustreznem poglavju navodila za uporabo vključena navedba, da morata biti ime in številka serije uporabljenega zdravila jasno zabeležena v kartoteki bolnika.
English: Contraceptives
Slovenian: Kontraceptivi
English: No reproduction studies in animals with asparaginase were performed but studies with asparaginase preparations in mice, rats, chicken and rabbits have shown embryotoxic and teratogenic effects (see section 5.3).
Slovenian: Opravili niso nobenih študij razmnoževanja pri živalih z asparaginazo, so pa študije z drugimi zdravili z asparaginazo pri miših, podganah, piščancih in kuncih pokazale embriotoksične in teratogene učinke (glejte poglavje 5.3).
English: The mean (Standard Deviation, SD) of the volume of distribution at steady state (Vdss) was 2.47 l (0.45 l).
Slovenian: Povprečje (standardna deviacija, SD) porazdelitvenega volumna v stanju dinamičnega ravnovesja (Vdss) je bilo 2,47 l (0,45 l).
English: The objective of the study was to demonstrate the non-inferiority of Spectrila to the reference E. coli-asparaginase with regard to the primary endpoint.
Slovenian: Cilj študije je bil dokazati neinferiornost zdravila Spectrila v primerjavi z referenčno asparaginazo E. coli glede primarnega končnega opazovanega dogodka.
English: Spectrila is used to treat adults and children with acute lymphoblastic leukaemia (ALL) which is a form of blood cancer.
Slovenian: Zdravilo Spectrila se uporablja za zdravljenje odraslih in otrok z akutno limfoblastno levkemijo (ALL), ki je oblika krvnega raka.
English: Concomitant treatment with corticosteroids contributes to this effect.
Slovenian: Sočasno zdravljenje s kortikosteroidi prispeva k temu učinku.
English: Based on results from animal studies and its mechanism of action, Spectrila should not be used during pregnancy unless the clinical condition of the woman requires treatment with asparaginase.
Slovenian: Na podlagi rezultatov študij na živalih in njenega mehanizma delovanja zdravila Spectrila ne smete uporabljati pri nosečnicah, razen če klinično stanje ženske zahteva zdravljenje z asparaginazo.
English: 6 22880 Wedel Germany
Slovenian: 22880 Wedel Nemčija
English: Peak (Cmax) of asparaginase activity in serum was reached with a delay of approximately 2 hours after the end of the infusion.
Slovenian: Največja (Cmax) aktivnost asparaginaze v serumu je bila dosežena z zakasnitvijo približno 2 ur po koncu infuzije.
English: Immediately after the end of infusion of asparaginase, serum levels of glutamine declined by a maximum of 50 % from pre-dose levels of about 400 µM but rapidly returned to normal values within a few hours.
Slovenian: Takoj po koncu infuzije asparaginaze se je serumska raven glutamina zmanjšala za največ 50 % od ravni pred odmerkom, ki je bila okrog 400 µM, a se je hitro, v nekaj urah, vrnila na normalne vrednosti.
English: Children 0 - 12 months old
Slovenian: Otroci, stari od 0 do 12 mesecev
English: Spectrila can induce antibodies of different immunoglobulin classes (IgG, IgM, IgE).
Slovenian: Zdravilo Spectrila lahko sproži nastajanje protiteles, ki spadajo v različne skupine imunoglobulinov (IgG, IgM, IgE).
English: In addition, treatment with asparaginase can result in disturbances in organ systems which exhibit a high level of protein synthesis.
Slovenian: Poleg tega lahko zdravljenje z asparaginazo povzroči motnje v organskih sistemih, v katerih je visoka raven sinteze beljakovin.
English: If allergic symptoms occur, administration of asparaginase must be discontinued immediately and appropriate treatment given, which may include antihistamines and corticosteroids.
Slovenian: Če nastopijo alergijski simptomi, je treba takoj prekiniti dajanje asparaginaze in zagotoviti ustrezno zdravljenje, ki lahko vključuje antihistaminike in kortikosteroide.
English: After induction treatment, patients continued treatment with chemotherapy regimens which included further treatment with asparaginases.
Slovenian: Po indukcijskem zdravljenju so bolniki nadaljevali zdravljenje s kemoterapevtskimi shemami, v katere je bilo vključeno nadaljnje zdravljenje z asparaginazami.
English: RPLS is treated symptomatically, including measures to treat any seizures.
Slovenian: RPLS zdravimo simptomatsko, vključno z ukrepi za zdravljenje kakršnih koli epileptičnih napadov.
English: There are no data on the use of asparaginase in pregnant women.
Slovenian: Podatkov o uporabi asparaginaze pri nosečnicah ni.
English: Low asparaginase activity levels are often accompanied by the appearance of anti-asparaginase antibodies.
Slovenian: Nizko raven aktivnosti asparaginaze pogosto spremlja pojav antiasparaginaznih protiteles.
English: This regimen has been shown to reduce the gastrointestinal and haematological effects of methotrexate.
Slovenian: Pokazali so, da ta shema zdravljenja zmanjša gastrointestinalne in hematološke učinke metotreksata.
English: Normal cells can make asparagine for themselves, while some cancer cells cannot.
Slovenian: Normalne celice lahko asparagin izdelujejo same, nekatere rakaste celice pa tega ne morejo.
English: • abnormal laboratory tests including changes in protein levels in the blood, changes in blood fat or in liver enzyme values or high level of urea in the blood
Slovenian: • abnormalni laboratorijski testi, vključno s spremembami ravni beljakovin v krvi, spremembami krvnih maščob ali vrednosti jetrnih encimov ali visoka raven sečnine v krvi.
English: Serum amylase and lipase are usually elevated, although in some patients they can be normal due to impaired protein synthesis.
Slovenian: Serumska amilaza in lipaza sta navadno zvišani, čeprav sta lahko pri nekaterih bolnikih normalni zaradi okvarjene sinteze beljakovin.
English: Concomitant vaccination with live vaccines increases the risk of serious infection.
Slovenian: Sočasna vakcinacija z živimi vakcinami zveča tveganje resne okužbe.
English: The mean ± SD terminal half-life (elimination half-life) of asparaginase activity in serum was 25.8 ± 9.9 h, with a range between 14.2 and 44.2 h.
Slovenian: Povprečni ± SD končni razpolovni čas (razpolovni čas izločanja) aktivnosti asparaginaze v serumu je bil 25,8 ± 9,9 ure, z razponom med 14,2 in 44,2 ure.
English: The mean asparagine concentrations in serum remained below 0.5 µM from immediately after the end of first infusion of asparaginase until at least three days after the last infusion.
Slovenian: Srednja serumska koncentracija asparagina je ostala pod 0,5 µM od takoj po koncu prve infuzije asparaginaze do vsaj tri dni po zadnji infuziji.
English: • coagulation disorders including symptomatic thrombosis related to the use of central venous catheters,
Slovenian: • motnje koagulacije, vključno s simptomatsko trombozo, povezano z uporabo centralnih venskih katetrov,
English: Duration of administration
Slovenian: Trajanje uporabe
English: If you are sexually mature you must use contraceptives or remain abstinent during chemotherapy and for up to 3 months after the end of treatment.
Slovenian: Če ste spolno zreli, morate med kemoterapijo in do 3 mesece po končanem zdravljenju uporabljati kontracepcijo ali se vzdržati spolnih odnosov.
English: Serum and urine glucose levels should be regularly monitored and managed as clinically indicated.
Slovenian: Redno moramo spremljati raven glukoze v serumu in urinu in jo obravnavati, kot je klinično indicirano.
English: Non-clinical repeat-dose toxicity and safety pharmacology studies in rats revealed no special hazard for humans, except a slight but significant saluretic effect at doses below the recommended dose for ALL/LBL patients.
Slovenian: Predklinične študije toksičnosti in varnostne farmakologije ponavljajočih se odmerkov pri podganah ne kažejo posebnega tveganja za človeka, razen majhnega, a značilnega saluretičnega učinka pri odmerkih, manjših od priporočenega odmerka za bolnike z ALL/LBL.
English: Concomitant administration of glucocorticoids may be a contributing factor.
Slovenian: Sočasno dajanje glukokortikoidov utegne biti dejavnik, ki k temu prispeva.
English: However, in rare cases it can result in diabetic ketoacidosis.
Slovenian: V redkih primerih pa lahko povzroči diabetično ketoacidozo.
English: Median (range) maximum serum concentrations of asparaginase activity were 2,324 U/l (1,6254,819 U/l).
Slovenian: Mediana (razpon) največje serumske koncentracije aktivnosti asparaginaze je bila 2.324 E/l (1.625-4.819 E/l).
English: In contrast to normal cells, lymphoblastic tumour cells have a very limited capacity for synthesising asparagine because of a significantly reduced expression of asparagine synthetase.
Slovenian: Za razliko od normalnih celic imajo limfoblastne tumorske celice zelo omejeno sposobnost sintetiziranja asparagina zaradi značilno zmanjšane ekspresije asparaginske sintetaze.
English: However, in rare cases severe hypertriglyceridaemia (triglycerides > 1,000 mg/dl) has been reported which increases the risk of development of acute pancreatitis.
Slovenian: Vendar so v redkih primerih poročali o hudi hipertrigliceridemiji (trigliceridi >1.000 mg/dl), ki zvečuje nevarnost razvoja akutnega pankreatitisa.
English: Recommended control examinations for patients of all age groups
Slovenian: Priporočeni kontrolni pregledi za bolnike vseh starostnih skupin Aktivnost asparaginaze
English: • depression, hallucination or confusion
Slovenian: • depresija, halucinacije ali zmedenost,
English: • mild tremor (shaking) of the fingers
Slovenian: • blag tremor (tresenje) prstov rok,
English: Qualitatively, the same asparaginase-induced adverse drug reactions are observed in adults and children; however, some of these undesirable effects (e.g. thromboembolic events) are known to occur with a higher frequency in adult patients compared to the paediatric population.
Slovenian: Pri odraslih in otrocih ugotavljajo kvalitativno enake neželene učinke zdravila, ki jih povzroča asparaginaza; vendar je znano, da se nekateri od teh neželenih učinkov (npr. trombembolični dogodki) pogosteje pojavljajo pri odraslih bolnikih kot v pediatrični populaciji.
English: • loss of appetite or weight loss
Slovenian: • izguba apetita ali hujšanje,
English: • a serious allergic reaction which causes difficulty in breathing or dizziness,
Slovenian: • resna alergijska reakcija, ki povzroči oteženo dihanje ali omedlevico,