FrancophonIA/ELRC3.0 huggingface dataset:
English: The hazard ratio (95% CI) was 0.71 (0.55, 0.93) between treatment arms favouring BLINCYTO, indicated a 29% reduction in hazard rate in the BLINCYTO arm (p-value = 0.012 (stratified log-rank test)), see figure 1.
Slovenian: Razmerje ogroženosti (95 % IZ) med terapevtskima skupinama je bilo 0,71 (0,55; 0,93) v korist zdravila BLINCYTO in se je kazalo z 29 % zmanjšanjem deleža ogroženosti v skupini z zdravilom BLINCYTO (p-vrednost = 0,012 (stratificirani log-rank test)), glejte sliko 1.
English: BLINCYTO can cause neurological problems such as dizziness, seizures, confusion, coordination and balance disorders.
Slovenian: Zdravilo BLINCYTO lahko povzroči nevrološke težave na primer omotico, napade krčev (konvulzije), zmedenost, motnje koordinacije in ravnotežja.
English: Solution (stabiliser): Colourless-to-slightly yellow, clear solution with a pH of 7.0.
Slovenian: Raztopina (stabilizator): Brezbarvna ali rumenkasta bistra raztopina s pH 7,0.
English: Patients with a medical history of neurologic signs and symptoms (such as dizziness, hypoaesthesia, hyporeflexia, tremor, dysaesthesia, paraesthesia, memory impairment) demonstrated a higher rate of neurologic events (such as tremor, dizziness, confusional state, encephalopathy and ataxia).
Slovenian: Bolniki z anamnezo nevroloških znakov in simptomov (kot so omotica, hipestezija, hiporefleksija, tremor, dizestezija, parestezija, okvara spomina) so imeli večji delež nevroloških učinkov (kot so tremor, omotica, stanje zmedenosti, encefalopatija in ataksija).
English: If you become pregnant during BLINCYTO treatment, please inform your doctor or nurse.
Slovenian: Če med zdravljenjem z zdravilom BLINCYTO zanosite, morate o tem obvestiti zdravnika ali medicinsko sestro.
English: There is limited experience with BLINCYTO in patients with an active uncontrolled infection.
Slovenian: Izkušenj z zdravilom BLINCYTO pri bolnikih z aktivno, neobvladano okužbo je malo.
English: BLINCYTO dose calculations are based on a usual overfill volume of 265 to 275 mL sodium chloride 9 mg/mL (0.9%) solution for injection.
Slovenian: Izračuni odmerka zdravila BLINCYTO temeljijo na običajni prepolnitvi količine od 265 do 275 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje.
English: In a post-hoc sensitivity analysis, compared to SOC, BLINCYTO consistently delayed the time to clinically meaningful deterioration of HRQoL (≥ 10-point worsening from baseline) for global health status [median BLINCYTO versus SOC: 8.1 months versus 1.0 month; HR = 0.60 (95% CI = 0.42, 0.85)], functional scales, symptom scales and individual items.
Slovenian: V post hoc analizi občutljivosti je zdravilo BLINCYTO v primerjavi s standardnim zdravljenjem dosledno podaljšalo čas do klinično pomembnega poslabšanja HRQoL (poslabšanje za ≥ 10 točk od izhodišča) za celotno zdravstveno stanje [mediana vrednosti za zdravilo BLINCYTO v primerjavi s standardnim zdravljenjem: 8,1 meseca v primerjavi z 1,0 mesec, razmerje ogroženosti = 0,60 (95 % IZ = 0,42; 0,85)], funkcijske lestvice, lestvice simptomov in posamezne postavke.
English: Neurologic events were reported for 71.5% of adult patients with MRD positive B-precursor ALL (N = 137) of which 22.6% were considered serious.
Slovenian: O nevroloških učinkih so poročali pri 71,5 % odraslih MRD-pozitivnih bolnikih z ALL predhodniških celic B (N = 137), pri čemer je bilo 22,6 % obravnavanih kot resnih.
English: Grade 4 Discontinue BLINCYTO permanently.
Slovenian: 4. stopnja Trajno prenehajte uporabljati zdravilo BLINCYTO.
English: Store and transport refrigerated.
Slovenian: Shranjujte in prevažajte na hladnem.
English: Among treated patients, the median age was 8 years (range: 7 months to 17 years), 40 out of 70 (57.1%) had undergone allogeneic HSCT prior to receiving BLINCYTO, and 39 out of 70 (55.7%) had refractory disease.
Slovenian: Mediana starosti zdravljenih bolnikov je bila 8 let (razpon: od 7 mesecev do 17 let), 40 od 70 (57,1 %) jih je imelo pred zdravljenjem z zdravilom BLINCYTO opravljeno alogensko presaditev krvotvornih matičnih celic, 39 od 70 (55,7 %) pa jih je imelo refraktarno bolezen.
English: The median OS was 15.6 months (CI 5.5 - not estimable) for the BLINCYTO group and 5.3 months (CI 1.1 - not estimable) for the SOC chemotherapy group.
Slovenian: Mediana celokupnega preživetja je bila v skupini z zdravilom BLINCYTO 15,6 mesecev (IZ 5,5 - ni ocenljivo) in v skupini s standardno kemoterapijo 5,3 mesecev (IZ 1,1 - ni ocenljivo).
English: This medicinal product provides less than 1 mmol (23 mg) sodium over a 24 hour infusion i.e. “essentially sodium-free”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija v 24-urni infuziji, kar pomeni, da je praktično ,,brez natrija“.
English: • swollen lymph nodes (lymphadenopathy)
Slovenian: • otekle bezgavke (limfadenopatija)
English: Two subjects achieved a complete MRD response with 1 additional cycle of BLINCYTO.
Slovenian: Dva bolnika sta dosegla popoln MRD odziv z 1 dodatnim ciklusom zdravljenja z zdravilom BLINCYTO.
English: RFS at 18 months not censored at HSCT or postBLINCYTO chemotherapy was 53% (44%, 62%).
Slovenian: Preživetje brez recidiva pri 18 mesecih brez krnjenja ob presaditvi krvotvornih matičnih celic ali kemoterapiji po zdravljenju z zdravilom BLINCYTO, je bilo 53 % (44 %, 62 %).
English: The safety and efficacy of BLINCYTO compared to standard of care (SOC) chemotherapy were evaluated in a randomised, open-label, multicentre, phase III study.
Slovenian: Varnost in učinkovitost zdravila BLINCYTO v primerjavi s standardno kemoterapijo so ocenili v randomizirani, multicentrični študiji III. faze z odprtim načrtom zdravljenja.
English: Chemical and physical in-use stability has been demonstrated for 10 days at 2°C - 8°C or 96 hours at or below 27°C.
Slovenian: Kemična in fizikalna stabilnost med uporabo sta bili dokazani za 10 dni pri temperaturi od 2 °C - 8 °C ali 96 ur pri temperaturi do vključno 27 °C.
English: For instructions on administration, see Summary of Product Characteristics section 4.2.
Slovenian: Za navodila za dajanje glejte poglavje 4.2 Povzetka glavnih značilnosti zdravila.
English: The safety and efficacy of BLINCYTO in adult patients with MRD positive B-precursor ALL were evaluated in an open-label, multicentre, single-arm study.
Slovenian: Varnost in učinkovitost zdravila BLINCYTO pri odraslih MRD-pozitivnih bolnikih z ALL predhodniških celic B sta bili ocenjeni v odprti, multicentrični študiji z eno samo skupino.
English: - The active substance is blinatumomab.
Slovenian: - Učinkovina je blinatumomab.
English: • chest pain or other pain
Slovenian: • bolečina v prsih ali drugje
English: 5 years (2°C - 8°C)
Slovenian: 5 let (2 °C - 8 °C) Rekonstituirana raztopina:
English: After reconstitution with water for injections each vial contains 12.5 micrograms/mL of blinatumomab.
Slovenian: Po rekonstituciji z vodo za injekcije vsebuje ena viala 12,5 mikrograma/ml blinatumomaba.
English: Cytokine release syndrome and infusion reactions
Slovenian: Sindrom sproščanja citokinov in infuzijske reakcije
English: 11.3 months (5.2, NE) (N = 119)
Slovenian: 11,3 mesecev (5.2; NO) (N = 119)
English: b, n (%) [95% CI] CR, n (%) [95% CI] CRh*, n (%) [95% CI] Complete MRD response for CR /CRh*
Slovenian: CRa/CRh*b, n (%) [95 % IZ] CR, n (%) [95 % IZ] CRh*, n (%) [95 % IZ] Popoln MRD odziv za CR/CRh*
English: • Recommendation for patients not to drive while receiving BLINCYTO and to contact immediately the treating physician if they experience neurological symptoms
Slovenian: • Priporočilo za bolnike, da v času prejemanja zdravila BLINCYTO, ne vozijo in takoj kontaktirajo zdravnika, če se pri njih pojavijo nevrološki simptomi.
English: If the toxicity occurred at 9 mcg/day, or if the toxicity takes more than 7 days to resolve, discontinue
Slovenian: Če se toksični učinek pojavi pri odmerku 9 µg/dan, ali če traja več kot 7 dni, da toksični učinek mine, trajno prenehajte uporabljati zdravilo
English: Your doctor will take regular blood tests during treatment with BLINCYTO.
Slovenian: Zdravnik bo med zdravljenjem z zdravilom BLINCYTO redno izvajal preiskave krvi.
English: The pharmacokinetics of blinatumomab appear linear over a dose range from 5 to 90 mcg/m2/day (approximately equivalent to 9-162 mcg/day) in adult patients.
Slovenian: Farmakokinetika blinatumomaba je pri odraslih bolnikih linearna v razponu odmerkov od 5 do 90 µg/m2/dan (to približno ustreza odmerkom od 9 do 162 µg/dan).
English: At a dose higher than the recommended dose, a case of fatal cardiac failure occurred in the setting of life-threatening cytokine release syndrome (CRS) and tumour lysis syndrome (TLS), see section 4.4.
Slovenian: Med uporabo odmerka, večjega od priporočenega odmerka, so zabeležili smrten primer srčnega popuščanja v okviru smrtno nevarnega sindroma sproščanja citokinov in sindroma lize tumorja, glejte poglavje 4.4.
English: • A solution (stabiliser) is provided inside the BLINCYTO package and is used to coat the pre-filled infusion bag prior to addition of reconstituted BLINCYTO.
Slovenian: • Pakiranju zdravila BLINCYTO je priložena raztopina (stabilizator), ki se uporablja za oblogo napolnjene infuzijske vrečke pred dodatkom rekonstituiranega zdravila BLINCYTO.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C or 4 hours at or below 27°C.
Slovenian: Kemična in fizikalna stabilnost med uporabo sta bili dokazani za 24 ur pri temperaturi od 2 °C8 °C ali 4 ure pri temperaturi do vključno 27 °C.
English: • neurologic events: shaking (or tremor), confusion, disturbances of brain function (encephalopathy), difficulty in communicating (aphasia), seizure (convulsion).
Slovenian: • nevrološki učinki: tresenje (tremor), zmedenost, moteno delovanje možganov (encefalopatija), težave s sporazumevanjem (afazija), napadi krčev (konvulzije).
English: Primary refractory
Slovenian: Primarno odporni
English: • 10 mL solution in a vial (type I glass) with a stopper (elastomeric rubber), seal (aluminium)
Slovenian: • 10 ml raztopine v viali (steklo tipa I) z zamaškom (elastomerna guma), zaporo (aluminij) in snemno zaporko.
English: There is limited experience with blinatumomab in patients with documented active ALL in the CNS or cerebrospinal fluid (CSF).
Slovenian: Z blinatumomabom je le malo izkušenj pri bolnikih z dokumentirano aktivno ALL v osrednjem živčevju ali cerebrospinalni tekočini.
English: BLINCYTO (N = 116)
Slovenian: Zdravilo BLINCYTO (N = 116)
English: Patients with brain MRI/CT findings consistent with leukoencephalopathy experienced concurrent serious adverse events including confusional state, tremor, cognitive disorder, encephalopathy, and convulsion.
Slovenian: Bolniki, pri katerih se je izvid MRI/CT možganov skladal z levkoencefalopatijo, so imeli ob tem resne neželene učinke, med njimi stanje zmedenosti, tremor, kognitivno motnjo, encefalopatijo in konvulzije.
English: 3.7 months (3.0, 5.3) (N = 65)
Slovenian: 3,7 mesecev (3,0; 5,3) (N = 65)
English: • a condition which causes fluid to leak from the small blood vessels into your body (capillary leak syndrome)
Slovenian: • motnja, ki povzroči pronicanje tekočine iz malih krvnih žil v telesu (sindrom povečane prepustnosti kapilar)
English: If your doctor determines that you should be given more cycles of BLINCYTO and if your body weight is greater than or equal to 45 kilograms, your pump will be set to infuse a dose of 28 micrograms per day.
Slovenian: Če zdravnik presodi, da morate dobiti več ciklusov zdravila BLINCYTO in če je vaša telesna masa enaka 45 kilogramov ali večja, vam bodo črpalko nastavili tako, da bo infundirala odmerek 28 mikrogramov na dan.
English: Based on pharmacokinetic analyses, dose adjustment is not necessary in patients with mild to moderate renal dysfunction (see section 5.2).
Slovenian: Na podlagi farmakokinetičnih analiz bolnikom z blago do zmerno motenim delovanjem ledvic odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: (%) [95% CI]
Slovenian: (%) [95 % IZ]
English: When considering the use of BLINCYTO as a treatment for Philadelphia chromosome negative MRD positive B-precursor ALL, quantifiable MRD should be confirmed in a validated assay with minimum sensitivity of 10
Slovenian: Ob presojanju o uporabi zdravila BLINCYTO za zdravljenje MRD-pozitivne ALL predhodniških celic B z negativnim Philadelphia kromosomom je treba potrditi količinsko določljivo MRD z validirano preiskavo z minimalno občutljivostjo 10
English: No studies have been conducted to evaluate treatment-related effects on fertility.
Slovenian: Študij za oceno učinkov zdravljenja na plodnost niso izvedli.
English: Table 8.
Slovenian: Preglednica 8.
English: 14 Chest pain includes chest discomfort, chest pain, musculoskeletal chest pain and non-cardiac chest pain.
Slovenian: Bolečina v prsih obsega nelagodje v prsih, bolečino v prsih, mišično-skeletno prsno bolečino in bolečino v prsih, ki ni povezana s srcem.
English: Powder for concentrate and solution for solution for infusion 1 vial of powder.
Slovenian: prašek za koncentrat in raztopina za raztopino za infundiranje 1 viala praška.
English: Reconstitution and preparation of BLINCYTO solution for infusion using an infusion bag pre-filled with 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection
Slovenian: Rekonstitucija in priprava raztopine zdravila BLINCYTO za infundiranje z uporabo napolnjene infuzijske vrečke z 250 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje
English: Figure 2.
Slovenian: Slika 2.
English: Patients with the highest tumour burden as measured by the percentage of bone marrow blast cells at baseline (≥ 90%) still had a clinically meaningful response with a CR/CRh* rate of 21.6% (CI 12.9 - 32.7) (see figure 2).
Slovenian: Tudi bolniki z največjim tumorskim bremenom, merjenim kot izhodiščni odstotek blastnih celic v kostnem mozgu (≥ 90 %), so dosegli klinično pomemben odziv z deležem CR/CRh* 21,6 % (IZ 12,9-32,7) (glejte sliko 2).
English: Reconstitution with water for injections results in a final blinatumomab concentration of 12.5 micrograms/mL.
Slovenian: Po rekonstituciji z vodo za injekcije je končna koncentracija blinatumomaba 12,5 mikrogramov/ml.
English: Direct the water for injections toward the side of the vial during reconstitution.
Slovenian: Med rekonstitucijo usmerite vodo za injekcije ob steno viale.
English: • Description of the administration procedures of BLINCYTO and how to reduce the risk of ME while using the infusion pump.
Slovenian: • Opis postopkov dajanja zdravila BLINCYTO in načinu zmanjšanja tveganja za napake pri uporabi zdravila, med uporabo infuzijske črpalke.
English: Twenty out of 70 (28.6%) patients achieved CR/CRh* within the first 2 treatment cycles with 17 out of 20 (85%) occurring within cycle 1 of treatment.
Slovenian: Dvajset od 70 (28,6 %) bolnikov je doseglo CR/CRh* v prvih dveh ciklusih zdravljenja in 17 od 20 odzivov (85 %) se je pojavilo v 1. ciklusu zdravljenja.
English: • feeling sleepy (somnolence), numbness, dizziness
Slovenian: • zaspanost (somnolenca), omrtvičenost, omotica
English: Appropriate prophylactic measures including aggressive hydration and anti-hyperuricaemic therapy (such as allopurinol or rasburicase) should be used for the prevention and treatment of TLS during BLINCYTO treatment, especially in patients with higher leukocytosis or a high tumour burden.
Slovenian: Za preprečevanje in zdravljenje sindroma lize tumorja je treba med zdravljenjem z zdravilom BLINCYTO uporabljati ustrezne profilaktične ukrepe, med njimi agresivno hidracijo in antihiperurikemična zdravila (npr. alopurinol ali razburikazo), zlasti pri bolnikih z visoko levkocitozo ali velikim tumorskim bremenom.
English: Elevated liver enzymes
Slovenian: Zvišanje jetrnih encimov
English: In clinical studies, patients with moderate renal impairment showed an increased incidence of TLS compared with patients with mild renal impairment or normal renal function.
Slovenian: V kliničnih študijah je bila incidenca sindroma lize tumorja pri bolnikih z zmerno okvaro ledvic večja kot pri bolnikih z blago okvaro ledvic ali normalnim delovanjem ledvic.
English: Time to alloHSCT among CR/CRh*/CRi responders Median time to event [95% CI] (KM estimate)
Slovenian: Čas do alloHSCT med odzivnimi bolniki CR/CRh*/CRi Mediana časa do dogodka [95 % IZ] (ocena KM)
English: • Infusion bag with 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection; o To minimise the number of aseptic transfers, use a 250 mL pre-filled infusion bag.
Slovenian: • infuzijska vrečka z 250 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje; o Da bi čim bolj omejili število aseptičnih prenosov, uporabite napolnjeno 250 ml infuzijsko vrečko.
English: Tell your doctor, pharmacist or nurse immediately if you became pregnant whilst receiving BLINCYTO.
Slovenian: Zdravniku, farmacevtu ali medicinski sestri takoj povejte, če med prejemanjem zdravila BLINCYTO zanosite.
English: In an embryo-foetal developmental toxicity study conducted in mice, the murine surrogate molecule crossed the placenta and did not induce embryotoxicity, or teratogenicity (see section 5.3).
Slovenian: V študiji razvojne toksičnosti za zarodek/plod na miših, so mišje nadomestne molekule prehajale placento in niso inducirale embriotoksičnosti ali teratogenosti (glejte poglavje 5.3).
English: In a prespecified exploratory analysis, 60 of 73 MRD evaluable patients with CR/CRh* (82.2%) also had a MRD response (defined as MRD by PCR < 1 x 10
Slovenian: V vnaprej opredeljeni eksploratorni analizi je imelo 60 od 73 bolnikov z minimalno rezidualno boleznijo, ki so bili primerni za analizo in so imeli CR/CRh* (82,2 %), tudi odziv minimalne rezidualne bolezni (opredeljen kot minimalna rezidualna bolezen s PCR < 1 x 10
English: The mortality rate following alloHSCT among all responders who did not receive anti-leukemic therapy was 10/38 (26.3%; 95% CI: 13.4, 43.1) in the BLINCYTO group and 3/12 (25%; 95% CI: 5.5, 57.2) in the SOC group; such mortality rate at 100 days post alloHSCT was 4/38 (12.4%; 95% CI: 4.8%, 29.9%) in the BLINCYTO group and 0/12 (0%; 95% CI: not estimable) in the SOC group.
Slovenian: Stopnja umrljivosti po alloHSCT med vsemi odzivnimi bolniki, ki niso prejeli antilevkemičnega zdravljenja, je bila 10/38 (26,3 %, 95 % IZ: 13,4; 43,1) v skupini z zdravilom BLINCYTO in 3/12 (25 %, 95 % IZ: 5,5; 57,2) v skupini s standardnim zdravljenjem; ta stopnja umrljivosti po 100 dneh po alloHSCT pa je bila 4/38 (12,4 %, 95 % IZ: 4,8 %; 29,9 %) v skupini z zdravilom BLINCYTO in 0/12 (0 %, 95 % IZ: ni ocenljivo) v skupini s standardnim zdravljenjem.
English: 7 Tachycardia includes sinus tachycardia, supraventricular tachycardia and tachycardia.
Slovenian: Tahikardija obsega sinusno tahikardijo, supraventrikularno tahikardijo in tahikardijo.
English: In case of exposure during pregnancy, depletion of B-cells may be expected in newborns due to the pharmacological properties of the product.
Slovenian: Zaradi farmakoloških lastnosti zdravila se lahko pri novorojenčkih pričakuje izčrpanje celic B v primeru izpostavljenosti blinatumomabu med nosečnostjo.
English: BLINCYTO is a powder for concentrate and solution for solution for infusion.
Slovenian: Zdravilo BLINCYTO je prašek za koncentrat in raztopina za raztopino za infundiranje.
English: Dose adjustments
Slovenian: Prilagoditve odmerka
English: 1 vial of solution (stabiliser).
Slovenian: 1 viala raztopine (stabilizatorja).
English: There is limited data in patients with late first relapse of B-precursor ALL defined as a relapse occurring more than 12 months after first remission or more than 12 months after HSCT in the first remission.
Slovenian: Podatki so omejeni pri bolnikih, ki imajo ALL s poznim prvim recidivom predhodniških celic B, definiran kot recidiv, ki se pojavi več kot 12 mesecev po prvi remisiji ali več kot 12 mesecev po presaditvi krvotvornih matičnih celic v prvi remisiji.
English: In clinical phase II studies, 88.9% (8/9) of patients with late first relapse as defined in the individual studies achieved CR/CRh* within the first 2 treatment cycles with 62.5% (6/9) achieving MRD response and 37.5% (3/9) undergoing allogeneic HSCT after treatment with BLINCYTO.
Slovenian: faze je 88,9 % (8/9) bolnikov s poznim prvim recidivom, kot je definiran v individualnih študijah, doseglo CR/CRh* med prvima 2 ciklusoma zdravljenja, 62,5 % (6/9) jih je doseglo odziv minimalne rezidualne bolezni, in 37,5 % (3/9) jih je po zdravljenju z zdravilom BLINCYTO opravilo alogensko presaditev krvotvornih matičnih celic.
English: How to use BLINCYTO
Slovenian: Kako uporabljati zdravilo BLINCYTO
English: Serious and grade ≥ 3 adverse reactions (such as ALT increased, AST increased, and blood bilirubin increased) were observed in 1.5% and 13.6% of patients respectively.
Slovenian: Resni neželeni učinki (kot so zvišanje ALT, zvišanje AST in zvišanje bilirubina v krvi) so se pojavili pri 1,5 % bolnikov, takšni neželeni učinki ≥ 3. stopnje pa pri 13,6 % bolnikov.
English: However, elderly patients may be more susceptible to serious neurologic events such as cognitive disorder, encephalopathy and confusion.
Slovenian: Lahko pa so starejši bolniki dovzetnejši za resne nevrološke učinke, kot so kognitivna motnja, encefalopatija in zmedenost.
English: The estimated mean (SD) volume of distribution based on terminal phase (Vz) was 4.52 (2.89) L with the continuous intravenous infusion of blinatumomab.
Slovenian: Ocenjeni povprečni (standardni odklon) volumen porazdelitve, ki temelji na terminalni fazi, je bil med stalnim intravenskim infundiranjem blinatumomaba 4,52 (2,89) l.
English: The physician educational material should contain: A link to the Summary of Product Characteristics (SmPC) The guide for physicians shall contain the following key elements:
Slovenian: Izobraževalno gradivo za zdravnike mora vsebovati: Povezavo na Povzetek glavnih značilnosti zdravila (SmPC) Vodnik za zdravnike mora vsebovati naslednje ključne točke:
English: 3.1 months (2.6, 4.3) (N = 32)
Slovenian: 3,1 mesecev (2,6; 4,3) (N = 32)
English: See method of administration.
Slovenian: Glejte način uporabe.
English: Eligible patients were ≥ 18 years of age with no prior HSCT, had received at least 3 blocks of standard ALL induction therapy, were in complete haematologic remission (defined as < 5% blasts in bone marrow, absolute neutrophil count ≥ 1,000/microlitres, platelets ≥ 50,000/microlitres, and haemoglobin level ≥ 9 g/dL) and had molecular failure or molecular relapse (defined as MRD ≥ 10
Slovenian: Za vključitev so bili primerni bolniki, stari ≥ 18 let, brez predhodne presaditve krvotvornih matičnih celic, ki so prejeli vsaj 3 bloke standardnega indukcijskega zdravljenja ALL, so bili v popolni hematološki remisiji (opredeljeno kot < 5 % blastov v kostnem mozgu, absolutno število nevtrofilcev ≥ 1.000/mikroliter, trombociti ≥ 50.000/mikroliter in raven hemoglobina ≥ 90 g/l) ter so imeli molekularno odpoved ali molekularni recidiv (opredeljeno kot MRD ≥ 10
English: BLINCYTO was administered as a continuous intravenous infusion.
Slovenian: Zdravilo BLINCYTO so uporabljali v kontinuirani intravenski infuziji.
English: • BLINCYTO is compatible with polyolefin, PVC non-di-ethylhexylphthalate (non-DEHP), or ethyl vinyl acetate (EVA) infusion bags/pump cassettes.
Slovenian: • Zdravilo BLINCYTO je kompatibilno s poliolefinskimi, PVC ne-dietilheksilftalatnimi (ne-DEHP) ali etilvinilacetatnimi (EVA) infuzijskimi vrečkami/kasetami za črpalke.
English: • decreased levels of certain white blood cells with or without fever ((febrile) neutropenia,
Slovenian: • zmanjšanje števila določenih belih krvnih celic z zvišano telesno temperaturo ali brez nje
English: Elderly patients may be more susceptible to serious neurologic events such as cognitive disorder, encephalopathy, and confusion.
Slovenian: Starejši bolniki so lahko bolj dovzetni za resne nevrološke učinke, kot so kognitivne motnje, encefalopatija in zmedenost.
English: Grade* Action for patients greater than or equal to 45 kg
Slovenian: Stopnja* Ukrepanje pri bolnikih, težkih 45 kg ali več
English: Verify the prescribed dose and infusion time of BLINCYTO and identify the appropriate dosing preparation section listed below.
Slovenian: Preverite predpisani odmerek in čas infundiranja zdravila BLINCYTO ter izberite ustrezno poglavje za pripravo odmerka, ki so navedeni spodaj.