natgillin/translations-raw huggingface dataset:
For patients with ≥ 50% leukaemic blasts in bone marrow or > 15,000/microlitre peripheral blood leukaemic blast counts treat with dexamethasone (not to exceed 24 mg/day).
Bolesnike s ≥ 50% leukemičnih blasta u koštanoj srži ili s > 15 000 leukemičnih blasta po mikrolitru periferne krvi potrebno je liječiti deksametazonom (ne smije se prekoračiti 24 mg/dan).
The most serious adverse reactions that may occur during blinatumomab treatment include: infections (24.8%), neurologic events (13.8%), neutropenia/febrile neutropenia (10.1%), cytokine release syndrome (3.3%), and tumour lysis syndrome (0.7%).
Najozbiljnije nuspojave do kojih može doći tijekom liječenja blinatumomabom uključuju: infekcije (24,8%), neurološke događaje (13,8%), neutropeniju/febrilnu neutropeniju (10,1%), sindrom otpuštanja citokina (3,3%) i sindrom lize tumora (0,7%).
4.5 months (3.6, 9.0)
4,5 mjeseca (3,6, 9,0)
The metabolic pathway of blinatumomab has not been characterised.
Metabolički put blinatumomaba nije još ustanovljen.
Treatment with BLINCYTO was associated with transient elevations in liver enzymes.
Liječenje lijekom BLINCYTO bilo je povezano s prolaznim povišenjem jetrenih enzima.
For instructions on the handling and preparation of the medicinal product before administration, see section 6.6.
Za upute o rukovanju i pripremi lijeka prije primjene, vidjeti dio 6.6.
Each BLINCYTO pack contains 1 vial of powder for concentrate for solution for infusion and 1 vial of solution (stabiliser):
Svako pakiranje lijeka BLINCYTO sadrži 1 bočicu praška za koncentrat za otopinu za infuziju i 1 bočicu otopine (stabilizatora):
Table 7 provides instructions for patients weighing greater than or equal to 45 kg, whereas table 8 and table 9 provide instructions for patients weighing less than 45 kg.
Tablica 7 daje upute za bolesnike tjelesne težine 45 kg ili veće, dok tablica 8 i tablica 9 daju upute za bolesnike tjelesne težine manje od 45 kg.
Store and transport refrigerated (2°C - 8°C).
Čuvati i prevoziti u hladnjaku (2°C - 8°C).
Grade 3 (CTCAE version 4.0) or higher (severe or life-threatening) neurologic events following initiation of blinatumomab administration included encephalopathy, seizures, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders.
Neurološki događaji 3. (CTCAE verzija 4.0) ili višeg (teški ili po život opasni) stupnja nakon započinjanja primjene blinatumomaba uključivali su encefalopatiju, napadaje, poremećaje govora, poremećaje svijesti, konfuziju i dezorijentaciju te poremećaje koordinacije i ravnoteže.
• difficulty in speaking
• otežan govor.
Tell your doctor, pharmacist or nurse immediately if you became pregnant whilst receiving BLINCYTO.
Odmah obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako zatrudnite dok se liječite lijekom BLINCYTO.
To coat the infusion bag, using a syringe, aseptically transfer 5.5 mL of the solution (stabiliser) to the infusion bag.
Za oblaganje infuzijske vrećice, koristeći štrcaljku aseptički prenesite 5,5 ml otopine (stabilizatora) u infuzijsku vrećicu.
The starting volume (270 mL) is more than the volume administered to the patient (240 mL) to account for the priming of the intravenous tubing and to ensure that the patient will receive the full dose of BLINCYTO.
Početni volumen (270 ml) veći je od volumena primijenjenog bolesniku (240 ml) zbog uračunatog volumena potrebnog za pripremu intravenske cjevčice i kako bi se osiguralo da će bolesnik primiti punu dozu lijeka BLINCYTO.
Complete MRD response a, n/N (%), [95% CI]
Potpuni MRB odgovor a, n/N (%), [95% CI]
Infusion reactions may be clinically indistinguishable from manifestations of CRS (see section 4.8).
Reakcije povezane s infuzijom ne moraju se klinički razlikovati od manifestacija CRS-a (vidjeti dio 4.8).
In the dose-finding part of the study, doses of up to 30 mcg/m 2/day were evaluated.
U dijelu ispitivanja za određivanje doze, procijenjene su doze do 30 µg/m 2/dan.
Patients with low tumour burden (< 50%) responded best to BLINCYTO treatment with CR/CRh* rate of 72.9% (CI 59.7 - 83.6).
Bolesnici s niskim tumorskim opterećenjem (< 50%) najbolje su odgovorili na liječenje lijekom BLINCYTO uz stopu CR/CRh* od 72,9% (CI 59,7 - 83,6).
However patients have been treated with blinatumomab in clinical studies after clearance of CSF blasts with CNS directed therapy (such as intrathecal chemotherapy).
Međutim, bolesnici su u kliničkim ispitivanjima liječeni blinatumomabom nakon klirensa blasta iz CST-a putem terapije usmjerene na SŽS (poput intratekalne kemoterapije).
Infusion-related reactions a
Reakcije povezane s infuzijom a
Eleven of the 20 patients (55%) who achieved CR/CRh* received an allogeneic HSCT.
Od 20 bolesnika koji su postigli CR/CRh* 11 (55%) je primilo alogenu HSCT.
Hepatic enzyme increased includes alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, hepatic enzyme increased and transaminases increased.
Povišeni jetreni enzimi uključuju povišenu alanin aminotransferazu, povišenu aspartat aminotransferazu, povišenu gama-glutamil transferazu, povišene jetrene enzime i povišene transaminaze.
• if you have ever had neurological problems, for example, shaking (or tremor), abnormal sensations, seizures, memory loss, confusion, disorientation, loss of balance, or difficulty in speaking.
• ako ste ikada imali neurološke probleme, na primjer tresavicu (ili tremor), abnormalne osjete, napadaje, gubitak pamćenja, smetenost, dezorijentaciju, gubitak ravnoteže ili poteškoće u govoru.
Repeat-dose toxicity studies conducted with blinatumomab and the murine surrogate revealed the expected pharmacologic effects (including release of cytokines, decreases in leukocyte counts, depletion of B-cells, decreases in T-cells, decreased cellularity in lymphoid tissues).
Ispitivanja toksičnosti opetovanog doziranja provedena s blinatumomabom i mišjim surogatom pokazala su očekivane farmakološke učinke (uključujući otpuštanje citokina, smanjenje broja leukocita, depleciju B limfocita, smanjenje broja T limfocita, smanjenje celularnosti u limfoidnim tkivima).
Disseminated intravascular coagulation (DIC) and capillary leak syndrome (CLS, e.g. hypotension, hypoalbuminaemia, oedema and haemoconcentration) have been commonly associated with CRS (see section 4.8).
Diseminirana intravaskularna koagulacija (DIC, od eng. disseminated intravascular coagulation) i sindrom povećane propusnosti kapilara (CLS, od eng. capillary leak syndrome; npr. hipotenzija, hipoalbuminemija, edem i hemokoncentracija) često se povezuju s CRS-om (vidjeti dio 4.8).
Weight increased Blood alkaline phosphatase increased
Povišena alkalna fosfataza u krvi
The anti-tumour activity of blinatumomab immunotherapy is not dependent on T-cells bearing a specific TCR or on peptide antigens presented by cancer cells, but is polyclonal in nature and independent of human leukocyte antigen (HLA) molecules on target cells.
Antitumorska aktivnost imunoterapije blinatumomabom ne ovisi o prisutnosti specifičnog TCR-a na površini T limfocita ili o specifičnim peptidima antigenima na površini tumorskih stanica, već je po prirodi poliklonska i ne ovisi o ljudskim leukocitnim antigenima (HLA) na ciljnim stanicama.
In patients receiving blinatumomab, serious infections, including sepsis, pneumonia, bacteraemia, opportunistic infections and catheter site infections have been observed, some of which were lifethreatening or fatal.
U bolesnika liječenih blinatumomabom opažene su ozbiljne infekcije uključujući sepsu, pneumoniju, bakterijemiju, oportunističke infekcije i infekcije na mjestu uvođenja katetera, od kojih su neke bile opasne po život ili imale smrtan ishod.
• fever (pyrexia), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (oedema), chills
• vrućica (pireksija), oticanje lica, usana, usne šupljine, jezika ili grla koje može uzrokovati otežano gutanje ili disanje (edem), zimica
Patients should be closely monitored for signs and symptoms of pancreatitis.
Bolesnike treba pozorno pratiti zbog znakova i simptoma pankreatitisa.
There is limited experience with blinatumomab in patients with documented active ALL in the CNS or cerebrospinal fluid (CSF).
Iskustvo s blinatumomabom u bolesnika s potvrđenim aktivnim ALL-om u SŽS-u ili cerebrospinalnoj tekućini (CST) je ograničeno.
BLINCYTO has been evaluated in paediatric patients with relapsed or refractory B-precursor ALL in a phase I/II dose escalation/evaluation study, in which 70 paediatric patients, aged 7 months to 17 years, were treated with the recommended dosage regimen.
BLINCYTO je procijenjen u pedijatrijskih bolesnika s recidivirajućim ili refraktornim ALL-om prekursora B limfocita u ispitivanju eskalacije doze/evaluacijskom ispitivanju faze I/II, u kojoj je 70 pedijatrijskih bolesnika dobi od 7 mjeseci do 17 godina liječeno preporučenim režimom doziranja.
Unopened vials: - Store and transport refrigerated (2°C - 8°C).
Neotvorene bočice: - Čuvati i prevoziti u hladnjaku (2°C - 8°C).
Pharmacokinetic analyses showed an approximately 2-fold difference in mean blinatumomab clearance values between patients with moderate renal dysfunction and normal renal function.
Farmakokinetičke analize pokazale su otprilike dvostruku razliku u srednjoj vrijednosti klirensa blinatumomaba između bolesnika s umjerenim oštećenjem funkcije bubrega i normalnom funkcijom bubrega.
One case of fatal encephalopathy has been reported in an earlier phase II clinical single-arm study.
Jedan slučaj encefalopatije sa smrtnim ishodom prijavljen je u ranijem kliničkom ispitivanju faze II s jednom skupinom.
Increase of T-cell counts above baseline (T-cell expansion) was observed in few patients.
Povećanje broja T limfocita iznad početne vrijednosti (ekspanzija T limfocita) opažena je u nekoliko bolesnika.
Some vaccines must not be given within two weeks before, at the same time as or in the months after you receive treatment with BLINCYTO.
Neka cjepiva se ne smiju primjenjivati unutar dva tjedna prije, tijekom liječenja ili mjesecima nakon što ste liječeni lijekom BLINCYTO.
Serious adverse events that may be signs and symptoms of CRS included pyrexia, asthenia, headache, hypotension, total bilirubin increased, and nausea; uncommonly, these events led to BLINCYTO discontinuation.
Ozbiljni štetni događaji koji mogu biti znakovi i simptomi CRS-a uključujući pireksiju, asteniju, glavobolju, hipotenziju, povišen ukupni bilirubin i mučninu; manje često, ovi su događaji doveli do trajnog prekida primjene lijeka BLINCYTO.
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.
Među liječenim bolesnicima, medijan dobi bio je 8 godina (raspon: 7 mjeseci do 17 godina), u 40 od 70 (57,1%) provedena je alogena HSCT prije nego su primili BLINCYTO, a 39 od 70 (55,7%) imalo je refraktornu bolest.
GRH0148v2
GRH0224HR v2
When administering via multi-lumen venous catheter, BLINCYTO should be infused through a dedicated lumen.
Prilikom primjene putem venskog katetera s višestrukim lumenima BLINCYTO se treba primijeniti infuzijom kroz zaseban lumen.
• Information on treatment with BLINCYTO, administration and posology, duration of hospitalisation, interruption and / or permanent discontinuation of the treatment Medication errors (ME)
• Informacije o liječenju lijekom BLINCYTO, njegovoj primjeni i doziranju, trajanju hospitalizacije, privremenom i/ili trajnom prekidu liječenja.
The target dose of 28 mcg/day was administered in cycle 2 and subsequent cycles starting on day 1 of each cycle.
Ciljna doza od 28 µg/dan primijenjena je u drugom ciklusu i svim sljedećim ciklusima, počevši od 1. dana svakog ciklusa.
MedDRA system organ class
Klasifikacija organskog sustava (MedDRA)
Based on pharmacokinetic analyses, no effect of baseline liver function on blinatumomab exposure is expected and adjustment of the initial dose is not necessary (see section 5.2).
Na temelju farmakokinetičkih analiza, ne očekuje se utjecaj početne vrijednosti funkcije jetre na izloženost blinatumomabu te nije potrebna prilagodba početne doze (vidjeti dio 5.2).
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.
Pri dozi višoj od preporučene doze, došlo je do slučaja srčanog zatajenja sa smrtnim ishodom u okviru po život opasnog sindroma otpuštanja citokina (CRS) i sindroma lize tumora (TLS), vidjeti dio 4.4.
Table 1 provides instructions for patients weighing greater than or equal to 45 kg whereas table 2 and table 3 provide instructions for patients weighing less than 45 kg.
Tablica 1 daje upute za bolesnike tjelesne težine 45 kg ili veće, dok tablica 2 i tablica 3 daju upute za bolesnike tjelesne težine manje od 45 kg.
• BLINCYTO is compatible with polyolefin, PVC non-di-ethylhexylphthalate (non-DEHP), or ethyl vinyl acetate (EVA) infusion bags/pump cassettes.
• BLINCYTO je kompatibilan s poliolefinskim, PVC (bez dietilheksilftalata (DEHP)) ili etilvinilacetat (EVA) vrećicama za infuziju/kasetama za pumpu.
Escalate to 15 mcg/m2/day after 7 days if the toxicity does not recur.
Povisite dozu na 15 µg/m2/dan nakon 7 dana ako se toksičnost ponovno ne javi.
Infusion duration
Trajanje infuzije
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.
Farmakokinetika blinatumomaba se pokazala linearna u rasponu doza od 5 do 90 µg/m2/dan (približno odgovara 9-162 µg/dan) u odraslih bolesnika.
The treated population included 189 patients who received at least 1 infusion of BLINCYTO; the mean number of cycles per patient was 1.6.
Liječena populacija uključivala je 189 bolesnika koji su primili najmanje 1 infuziju lijeka BLINCYTO; srednja vrijednost broja ciklusa po bolesniku bio je 1,6.
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.
Ograničeni su podaci u bolesnika s kasnim prvim recidivom ALL-a prekursora limfocita B, definiranim kao recidiv koji se pojavio više od 12 mjeseci nakon prve remisije ili više od 12 mjeseci nakon HSCT-a u prvoj remisiji.
• neurologic events: shaking (or tremor), confusion, disturbances of brain function (encephalopathy), difficulty in communicating (aphasia), seizure (convulsion).
• neurološki događaji: tresavica (ili tremor), smetenost, poremećaj funkcije mozga (encefalopatija), poteškoće u komuniciranju (afazija), napadaji (konvulzije).
BLINCYTO can cause neurological problems such as dizziness, seizures, confusion, coordination and balance disorders.
BLINCYTO može uzrokovati neurološke probleme poput omaglice, napadaja, smetenosti te poremećaja koordinacije i ravnoteže.
• Recommendation to monitor patients for signs and symptoms of neurotoxicity
• Preporuka da se bolesnika prati radi znakova i simptoma neurotoksičnosti.
After reconstitution with water for injections each vial contains 12.5 micrograms/mL of blinatumomab.
Nakon rekonstitucije s vodom za injekcije svaka bočica sadrži 12,5 mikrograma/ml blinatumomaba.
BLINCYTO is usually given for 2 treatment cycles if you have relapsed/refractory acute lymphoblastic leukaemia, or for 1 treatment cycle if you have minimal residual disease acute lymphoblastic leukaemia.
BLINCYTO se obično daje u 2 ciklusa liječenja ako imate recidivirajuću ili refraktornu akutnu limfoblastičnu leukemiju ili 1 ciklus liječenja ako imate akutnu limfoblastičnu leukemiju s minimalnom rezidualnom bolešću.
Decreased immunoglobulins
Sniženi imunoglobulini
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. - Dojenje (vidjeti dio 4.6).
Your doctor will take regular blood tests to monitor your blood counts during treatment with BLINCYTO.
Vaš liječnik će provoditi redovite krvne pretrage kako bi pratio broj Vaših krvnih stanica tijekom liječenja lijekom BLINCYTO.
In this open-label study, Health related quality of life (HRQoL) reported by patients were measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30).
Health Related Quality of Life) koju su prijavili bolesnici mjerena je korištenjem upitnika EORTC QLQ-C30.
• Reminder to counsel the patients on how to reduce the risk of ME while using the infusion pump.
• Podsjetnik za savjetovanje bolesnika o tome kako smanjiti rizik od medikacijskih pogrešaka tijekom primjene infuzijske pumpe.
Blinatumomab is associated with transient upregulation of cell adhesion molecules, production of cytolytic proteins, release of inflammatory cytokines, and proliferation of T-cells, and results in elimination of CD19+ cells.
Blinatumomab je povezan s prolaznom uzvodnom regulacijom staničnih adhezijskih molekula, proizvodnjom citolitičkih proteina, otpuštanjem upalnih citokina i proliferacijom T limfocita, te rezultira eliminacijom CD19+ stanica.
(thrombocytopenia), decreased levels of certain white blood cells (leukopenia)
(trombocitopenija), smanjene razine određenih bijelih krvnih stanica (leukopenija)
No studies have been conducted to evaluate the effects of blinatumomab on fertility.
Nisu provedena ispitivanja za procjenu učinka blinatumomaba na plodnost.
At the recommended doses, the mean (SD) steady state concentration (Css) values were 162 (179) and 533 (392) pg/mL at 5 and 15 mcg/m2/day doses, respectively.
Pri preporučenim dozama srednje vrijednosti (SD) koncentracije u stanju dinamičke ravnoteže (Css) bile su 162 (179) i 533 (392) pg/ml pri dozama od 5 i 15 µg/m2/dan.
In an embryo-foetal developmental toxicity study performed in mice, the murine surrogate crossed the placenta to a limited extent (foetal-to-maternal serum concentration ratio < 1%) and did not induce embryo-foetal toxicity or teratogenicity.
U ispitivanju embrio-fetalne razvojne toksičnosti provedenom u miševa, mišji surogat prešao je placentalnu barijeru u ograničenom rasponu (omjer koncentracija u serumu fetusa u odnosu na majku < 1%) i nije inducirao embrio-fetalnu toksičnost ili teratogenost.
The most common adverse reactions were: pyrexia (69.2%), infusion-related reactions (43.4%), infections - pathogen unspecified (42.1%), headache (32.9%), anaemia (22.8%), thrombocytopenia (20.9%), febrile neutropenia (20.2%), oedema (20.0%), neutropenia (19.7%), rash (16.7%), increased liver hepatic enzymes (16.1%), bacterial infectious disorders (15.4%), tremor (15.2%), cough (15.1%), leukopenia (13.4%), back pain (13.3%), chills (13.0%), hypotension (12.8%), viral infectious disorders (12.7%), decreased immunoglobulins (12.5%), cytokine release syndrome (11.6%), tachycardia (11.3%), insomnia (10.7%), fungal infectious disorders (10.6%) and pain in extremity (10.2%).
Najčešće nuspojave bile su: pireksija (69,2%), reakcije povezane s infuzijom (43,4%), infekcijepatogen neodređen (42,1%), glavobolja (32,9%), anemija (22,8%), trombocitopenija (20,9%), febrilna neutropenija (20,2%), edem (20,0%), neutropenija (19,7%), osip (16,7%), povišeni jetreni enzimi (16,1%), bakterijske zarazne bolesti (15,4%), tremor (15,2%), kašalj (15,1%), leukopenija (13,4%), bolovi u leđima (13,3%), zimica (13,0%), hipotenzija (12,8%), virusne zarazne bolesti (12,7%), sniženi imunoglobulini (12,5%), sindrom otpuštanja citokina (11,6%), tahikardija (11,3%), nesanica (10,7%), gljivične zarazne bolesti (10,6%) i bolovi u udovima (10,2%).
The most frequently reported serious adverse events were pyrexia (11.4%), febrile neutropenia (11.4%), cytokine release syndrome (5.7%), sepsis (4.3%), device-related infection (4.3%), overdose (4.3%), convulsion (2.9%), respiratory failure (2.9%), hypoxia (2.9%), pneumonia (2.9%), and multi-organ failure (2.9%).
Najčešće prijavljivani ozbiljni štetni događaji bili su pireksija (11,4%), febrilna neutropenija (11,4%), sindrom otpuštanja citokina (5,7%), sepsa (4,3%), infekcije povezane s uređajem (4,3%), previsoka doza (4,3%), konvulzije (2,9%), respiratorno zatajenje (2,9%), hipoksija (2,9%), upala pluća (2,9%) i višestruko zatajenje organa (2,9%).
Nervous system disorders a
Poremećaji živčanog sustava a
If you have relapsed/refractory acute lymphoblastic leukaemia and your body weight is greater than or equal to 45 kilograms the recommended initial dose in your first cycle is 9 micrograms per day for 1 week.
Ako imate recidivirajuću ili refraktornu akutnu limfoblastičnu leukemiju i ako je Vaša tjelesna težina 45 kg ili veća, preporučena početna doza u Vašem prvom ciklusu je 9 mikrograma na dan u 1. tjednu.
The treated population included 116 patients who received at least one infusion of BLINCYTO; the mean number of completed treatment cycles was 1.8 (range: 1 to 4).
Liječena populacija uključivala je 116 bolesnika koji su primili najmanje jednu infuziju lijeka BLINCYTO; srednja vrijednost dovršenih ciklusa po bolesniku bila je 1,8 (raspon: 1 do 4).
Reconstitution with water for injections results in a final blinatumomab concentration of 12.5 micrograms/mL.
Rekonstitucija s vodom za injekcije rezultira konačnom koncentracijom blinatumomaba od 12,5 mikrograma/ml.
Most patients had a high tumour burden (≥ 50% leukaemic blasts in bone marrow) at baseline with a median of 75.5% bone marrow blasts.
Većina bolesnika imala je na početku liječenja veliko tumorsko opterećenje (≥ 50% leukemičnih blasta u koštanoj srži) s medijanom od 75,5% blasta u koštanoj srži.
• decreased levels of red blood cells (anaemia), decreased levels of platelets
• smanjene razine crvenih krvnih stanica (anemija), smanjene razine krvnih pločica
Rate and 95% Confidence Interval (CI)
Stopa i interval pouzdanosti (CI) 95%
Use an infusion bag pre-filled with 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection that usually contains a total volume of 265 to 275 mL.
Koristite infuzijsku vrećicu od 250 ml otopine natrijeva klorida 9 mg/ml (0,9%) za injekcije koja obično sadrži sveukupni volumen od 265 do 275 ml.
• nerve problems affecting the head and neck such as visual disturbances, drooping eyelid and/or sagging muscles on one side of the face, difficulty hearing or trouble swallowing
• problemi sa živcima koji pogađaju područje glave i vrata, kao što su poremećaji vida, spušten očni kapak i/ili opuštenost mišića jedne strane lica, poteškoće sa sluhom ili poteškoće pri gutanju (poremećaji kranijalnih živaca)
Characteristic
Karakteristike
MRD status at screening was determined from bone marrow aspirations using flow cytometry or polymerase chain reaction (PCR) at a minimum sensitivity of 10
), vidjeti tablicu 4. MRB status prilikom probira određen je iz aspiracija koštane srži protočnom citometrijom ili lančanom reakcijom polimeraze (PCR) uz minimalnu osjetljivost od 10
leukopenia), decreased levels of red blood cells, decreased levels of platelets
leukopenija), smanjene razine crvenih krvnih stanica, smanjene razine krvnih pločica
- The active substance is blinatumomab.
- Djelatna tvar je blinatumomab.
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).
U ispitivanju embrio-fetalne razvojne toksičnosti provedenom na miševima, mišja surogatna molekula je prešla placentu i nije inducirala embriotoksičnost ili teratogenost (vidjeti dio 5.3).
For reinitiation, premedicate with a 24 mg dose of dexamethasone.
Za ponovno uvođenje lijeka potrebna je premedikacija deksametazonom u dozi od 24 mg.