natgillin/translations-raw huggingface dataset:
This medicine should be inspected visually for particulate matter and discolouration prior to administration.
To zdravilo je treba pred uporabo pregledati glede prisotnosti vidnih delcev in obarvanosti.
BESPONSA 1 mg powder for concentrate for solution for infusion
BESPONSA 1 mg prašek za koncentrat za raztopino za infundiranje
BESPONSA 1 mg powder for concentrate for solution for infusion inotuzumab ozogamicin
BESPONSA 1 mg prašek za koncentrat za raztopino za infundiranje inotuzumab ozogamicin
In the pivotal study (N=164), increases in amylase and lipase were reported in 8 (5%) and 15 (9%) patients, respectively.
V ključnem preskušanju (n = 164) so o zvečanih vrednostih amilaze in lipaze poročali pri 8 (5 %) oziroma 15 (9 %) bolnikih.
Study 2: Efficacy results in patients ≥ 18 years of age with relapsed or refractory B-cell precursor ALL who received 2 or more prior treatment regimens for ALL
Študija 2: Rezultati učinkovitosti pri bolnikih, starih ≥ 18 let, z recidivno ali refraktarno prekurzorsko B-celično ALL, ki so prejeli 2 ali več predhodnih režimov zdravljenja za ALL
Febrile neutropenia (26%) Neutropenia (49%) Thrombocytopenia (51%) Leukopenia (35%) Lymphopenia (18%) Anaemia (36%)
Bolezni krvi in limfatičnega sistema febrilna nevtropenija (26 %) nevtropenija (49 %) trombocitopenija (51 %) levkopenija (35 %) limfopenija (18 %) anemija (36 %)
Men must use effective contraception during treatment and for at least 5 months after the last dose of treatment.
Moški morajo med zdravljenjem in vsaj 5 mesecev po zadnjem odmerku zdravila uporabljati učinkovito metodo kontracepcije.
Formal carcinogenicity studies have not been conducted with inotuzumab ozogamicin.
Formalnih preskušanj kancerogenosti z inotuzumab ozogamicinom niso izvedli.
In the pivotal study (N=164), hyperbilirubinaemia and increased transaminases were reported in 35 (21%) and 43 (26%) patients, respectively.
V ključnem preskušanju (n = 164) so o hiperbilirubinemiji oziroma zvečanju vrednosti transaminaz poročali pri 35 (21 %) oziroma 43 (26 %) bolnikih.
For severe or life-threatening infusion reactions, treatment should be permanently discontinued (see section 4.2).
Pri hudih ali življenjsko ogrožajočih reakcijah na infuzijo je treba zdravljenje trajno prekiniti (glejte poglavje 4.2).
In vitro, N-acetyl-gamma-calicheamicin dimethylhydrazide is a substrate of P-glycoprotein (P-gp).
N-acetil-gama-kaliheamicin dimetilhidrazid je in vitro substrat glikoproteina P (P-gp).
The safety and efficacy of BESPONSA have not been studied in patients with end-stage renal disease.
Varnosti in učinkovitosti zdravila BESPONSA pri bolnikih s končno ledvično odpovedjo niso preučevali.
Furthermore, at month 24, the survival probability was 38.0% (95% CI: 27.4, 48.5) for patients who underwent a follow-up HSCT compared to 8.0% (95% CI: 3.3, 15.3) for patients who did not undergo a follow-up HSCT in the BESPONSA arm.
Poleg tega je bila po 24 mesecih verjetnost preživetja v skupini z zdravilom BESPONSA 38,0 % (95 % IZ: 27,4; 48,5) pri bolnikih, ki so jim v nadaljevanju opravili PKMC, v primerjavi z 8,0 % (95 % IZ: 3,3; 15,3) pri bolnikih, ki jim v nadaljevanju niso opravili PKMC.
Based on population pharmacokinetic analysis in 765 patients, the clearance of inotuzumab ozogamicin in patients with mild renal impairment (CLcr 60-89 mL/min; n=237), moderate renal impairment (CLcr 30-59 mL/min; n=122), or severe renal impairment (CLcr 15-29 mL/min; n=4) was similar to patients with normal renal function (CLcr ≥ 90 mL/min; n=402) (see section 4.2).
S populacijsko farmakokinetično analizo pri 765 bolnikih so ugotovili, da je bil očistek inotuzumab ozogamicina pri bolnikih z blago (CLcr 60-89 ml/min; n = 237), zmerno (CLcr 30-59 ml/min; n = 122) ali hudo okvaro ledvic (CLcr 15-29 ml/min; n=4) podoben kot pri bolnikih z normalnim delovanjem ledvic (CLcr ≥ 90 ml/min; n = 402) (glejte poglavje 4.2).
Based on in vitro data, coadministration of inotuzumab ozogamicin with inhibitors or inducers of cytochrome P450 (CYP) or uridine diphosphate-glucuronosyltransferase (UGT) drug metabolising enzymes are unlikely to alter exposure to N-acetyl-gamma-calicheamicin dimethylhydrazide.
Na osnovi podatkov in vitro glede sočasne uporabe inotuzumab ozogamicina z zaviralci ali induktorji citokroma P450 (CYP) ali encimi uridin-difosfo-glukuronoziltransferaz (UGT) za presnovo zdravil ni verjetno, da bi spremenila izpostavljenost N-acetil-gama-kaliheamicin dimetilhidrazidu.
a +/- 2 days (maintain a minimum of 6 days between doses).
± 2 dni (med odmerki mora miniti vsaj 6 dni).
MRD negativityc for patients achieving CR/CRi; rated (%) [95% CI]
Negativen izvid za MRD c pri bolnikih, ki so dosegli CR/CRi; stopnja d (%) [95 %
In patients receiving inotuzumab ozogamicin, neutropenia, thrombocytopenia, anaemia, leukopenia, febrile neutropenia, lymphopenia, and pancytopenia, some of which were life-threatening, have been reported (see section 4.8).
Pri bolnikih, ki so prejemali inotuzumab ozogamicin, so poročali o nevtropeniji, trombocitopeniji, anemiji, levkopeniji, febrilni nevtropeniji, limfopeniji in pancitopeniji; nekateri od teh primerov so bili življenjsko ogrožajoči (glejte poglavje 4.8).
In the Phase 2 portion of the study, patients had to have received at least 2 prior treatment regimens for ALL and patients with Ph+ B-cell ALL had to have failed treatment with at least 1 TKI.
V 2. fazi študije so bolniki morali prejeti najmanj 2 predhodna režima zdravljenja za ALL, bolniki s Ph
Infection (48%)a (includes Sepsis and Bacteraemia [17%], Fungal infection [9%], Lower respiratory tract infection [12%)], Upper respiratory tract infection [12%], Bacterial infection [1%], Viral infection [7%], Gastrointestinal infection [4%], Skin infection [4%])
a (vključuje sepso in bakteriemijo [17 %], glivično okužbo [9 %], okužbo spodnjih dihal [12 %], okužbo zgornjih dihal [12 %], bakterijsko okužbo [1 %], virusno okužbo [7 %], okužbo prebavil [4 %], okužbo kože [4 %])
Increases in Grade ≥ 3 amylase and lipase were reported in 3 (2%) and 7 (4%) patients, respectively.
O zvečanih vrednostih amilaze in lipaze stopnje ≥ 3 so poročali pri 3 (2 %) oziroma 7 (4 %) bolnikih.
At month 24, the survival probability was 38.0% (95% CI: 27.4, 48.5) versus 35.5% (95% CI: 20.1, 51.3) for BESPONSA and Investigator's choice of chemotherapy, respectively.
Po 24 mesecih je bila verjetnost preživetja 38,0 % (95 % IZ: 27,4; 48,5) v primerjavi s 35,5 % (95 % IZ: 20,1; 51,3) za zdravilo BESPONSA oziroma kemoterapijo po izbiri raziskovalca.
Type I amber glass vial with chlorobutyl rubber stopper and crimp seal with flip off cap containing 1 mg of powder.
Viala iz rjavega stekla tipa I z zamaškom iz klorobutilne gume in objemno zaporko s snemljivim pokrovčkom, ki vsebuje 1 mg praška.
What BESPONSA looks like and contents of the pack
Izgled zdravila BESPONSA in vsebina pakiranja
The use of HSCT conditioning regimens containing 2 alkylating agents should be avoided.
Izogibajte se uporabi pripravljalnih shem za PKMC, ki vključujejo 2 alkilirajoča citostatika.
No adjustment to the starting dose is required in patients with mild, moderate, or severe renal impairment (creatinine clearance [CLcr] 60-89 mL/min, 30-59 mL/min, or 15-29 mL/min, respectively) (see section 5.2).
Pri bolnikih z blago, zmerno ali hudo okvaro ledvic (očistek kreatinina [CLcr] 60-89 ml/min, 30-59 ml/min ali 15-29 ml/min) prilagajanje začetnega odmerka ni potrebno (glejte poglavje 5.2).
Grade 4 thrombocytopenia and neutropenia were reported in 46 (28%) and 45 (27%) patients, respectively.
O trombocitopeniji oziroma nevtropeniji stopnje 4 so poročali pri 46 (28 %) oziroma 45 (27 %) bolnikih.
Study 1: Efficacy results in patients ≥ 18 years of age with relapsed or refractory B-cell precursor ALL who received 1 or 2 prior treatment regimens for ALL
Študija 1: Rezultati učinkovitosti pri bolnikih, starih ≥ 18 let, z recidivno ali refraktarno prekurzorsko B-celično ALL, ki so prejeli 1 ali 2 predhodna režima zdravljenja za ALL
After reconstitution (see section 6.6), 1 mL of solution contains 0.25 mg inotuzumab ozogamicin.
Po rekonstituciji (glejte poglavje 6.6) 1 ml raztopine vsebuje 0,25 mg inotuzumab ozogamicina.
In the following subgroups, the reported frequency of VOD/SOS post-HSCT was ≥ 50%: - Patients who received a HSCT conditioning regimen containing 2 alkylating agents; - Patients aged ≥ 65 years; and
Pri naslednjih podskupinah so poročali o VOD/SOS po PKMC s pogostnostjo ≥ 50 %: - pri bolnikih, ki so prejeli pripravljalno shemo za PKMC, ki je vključevala 2 alkilirajoča citostatika; - pri bolnikih, starih ≥ 65 let; - pri bolnikih z vrednostjo bilirubina v serumu pred PKMC ≥ ZMN.
In repeat dose toxicity studies in rats and monkeys, female reproductive findings included atrophy of ovaries, uterus, vagina, and mammary gland.
V preskušanjih toksičnosti pri ponavljajočih odmerkih pri podganah in opicah so ugotovitve glede ženskih reprodukcijskih organov vključevale atrofijo jajčnikov, maternice, nožnice in mlečne žleze.
Decreased appetite (12%)
Presnovne in prehranske motnje zmanjšan apetit (12 %)
Your doctor will take regular blood tests to monitor your liver enzymes during treatment with BESPONSA.
Zdravnik bo med zdravljenjem z zdravilom BESPONSA opravljal redne preiskave krvi za spremljanje jetrnih encimov.
Inotuzumab ozogamicin was clastogenic in vivo in the bone marrow of male mice.
Inotuzumab ozogamicin je bil klastogen in vivo v kostnem mozgu mišjih samcev.
Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of a recombinant humanised IgG4 kappa CD22-directed monoclonal antibody (produced in Chinese hamster ovary cells by recombinant DNA technology) that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.
Inotuzumab ozogamicin je imunokonjugat (ADC - Antibody-Drug Conjugate), sestavljen iz rekombinantnega humaniziranega monoklonskega protitelesa IgG4 kapa, ki je usmerjeno proti CD22 (pridobljen s tehnologijo rekombinantne DNK v ovarijskih celicah kitajskega hrčka) in kovalentno vezano na N-acetil-gama-kaliheamicin dimetilhidrazid.
• venoocclusive liver disease (see section 2); signs and symptoms include rapid weight gain, pain in the upper right side of your abdomen, increase in the size of the liver, accumulation of fluid causing abdominal swelling, and increases in bilirubin and/or liver enzymes (that may result in yellowing of the skin or eyes).
• venookluzivna bolezen jeter (glejte poglavje 2); znaki in simptomi vključujejo zvečanje telesne mase, bolečino v zgornjem desnem predelu trebuha, zvečanje velikosti jeter, kopičenje tekočine, kar povzroča otekanje trebuha, in zvečanje vrednosti bilirubina in/ali jetrnih encimov (kar lahko povzroči rumenkasto obarvanje kože ali oči).
Hazard ratio [95% CI] = 0.450 [0.348-0.581] 2-sided p-value < 0.0001
razmerje ogroženosti (95 % IZ) = 0,450 (0,348-0,581) 2-stranska vrednost p < 0,0001
BESPONSA contains no bacteriostatic preservatives.
Zdravilo BESPONSA ne vsebuje bakteriostatičnih konzervansov.
Dose modification(s)
Prilagoditev(-e) odmerka
Patients who have not achieved a CRc or CRid: Dose (mg/m2)
Bolniki, ki niso dosegli CR c ali CRi odmerek (mg/m dolžina cikla
N-acetyl-gamma-calicheamicin dimethylhydrazide (the cytotoxic agent released from inotuzumab ozogamicin) was mutagenic in an in vitro bacterial reverse mutation (Ames) assay.
N-acetil-gama-kaliheamicin dimetilhidrazid (citotoksična učinkovina, ki jo sprošča inotuzumab ozogamicin) je deloval mutageno pri in vitro preskusu bakterijske reverzne mutacije (Amesov preskus).
In patients receiving inotuzumab ozogamicin, TLS, which may be life-threatening or fatal, was reported (see section 4.8).
Pri bolnikih, ki so prejemali inotuzumab ozogamicin, so poročali o TLS, ki je lahko življenjsko ogrožajoč ali smrten (glejte poglavje 4.8).
• low number of blood cells known as neutrophils, (sometimes accompanied with fever), red blood cells, white blood cells, lymphocytes, or low number of blood components known as platelets (see section 2); signs and symptoms include developing an infection or fever or bruising easily or getting nose bleeds on a regular basis.
• nizko število krvnih celic, imenovanih nevtrofilci (kar včasih spremlja vročina), rdečih krvnih celic, belih krvnih celic, limfocitov ali nizko število krvnih sestavin, imenovanih trombociti (glejte poglavje 2); znaki in simptomi vključujejo pojav okužbe ali vročine, hitro pojavljanje modric ali pogoste krvavitve iz nosu.
Grade ≥ 3 hyperbilirubinaemia and increased transaminases were reported in 9 (6%) and 11 (7%) patients, respectively.
O hiperbilirubinemiji oziroma zvečanju vrednosti transaminaz stopnje ≥ 3 so poročali pri 9 (6 %) oziroma 11 (7 %) bolnikih.
The dose of inotuzumab ozogamicin is administered based on body surface area (see section 4.2).
Odmerek inotuzumab ozogamicina je treba dajati glede na telesno površino (glejte poglavje 4.2).
If platelet count decreases, interrupt the next cycle of treatment until platelet count recovers to ≥ 50 × 109/La.
Če se število trombocitov zmanjša, prekinite naslednji cikel zdravljenja, dokler se njihovo število ne vrne na ≥ 50 × 10
In the pivotal study (N=164), maximum increases in QT interval corrected for heart rate using the Fridericia formula (QTcF) ≥ 30 msec and ≥ 60 msec from baseline were measured in 30/162 (19%) and 4/162 (3%) patient, respectively.
V ključnem preskušanju (n = 164) so največja podaljšanja intervala QT, korigiranega glede na srčni utrip s popravkom Fridericia (QTcF), ≥ 30 ms in ≥ 60 ms od izhodišča izmerili pri 30/162 (19 %) in 4/162 (3 %) bolnikov.
Studies in animals have shown reproductive toxicity (see section 5.3).
Preskušanja na živalih so pokazala vpliv na sposobnost razmnoževanja (glejte poglavje
• Excessive accumulation of fluid in the abdomen
• čezmerno kopičenje tekočine v trebuhu
Men with female partners of childbearing potential should use effective contraception during treatment with BESPONSA and for at least 5 months after the last dose.
Moški s partnerkami v rodni dobi morajo med zdravljenjem z zdravilom BESPONSA in vsaj 5 mesecev po zadnjem odmerku uporabljati učinkovito metodo kontracepcije.
In repeat dose toxicity studies in rats, male reproductive findings included testicular degeneration, associated with hypospermia, and prostatic and seminal vesicle atrophy.
V preskušanjih toksičnosti pri ponavljajočih odmerkih pri podganah in opicah so ugotovitve glede moških reprodukcijskih organov vključevale degeneracijo testisov, povezano s hipospermijo in atrofijo prostate in semenjaka.
For periodic monitoring of increased amylase and lipase, see section 4.4.
Za redno spremljanje zvečanja vrednosti amilaze in lipaze glejte poglavje 4.4.
No adjustment to the starting dose is required in patients with hepatic impairment defined by total bilirubin ≤ 1.5 × upper limit of normal (ULN) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN (see section 5.2).
Pri bolnikih z okvaro jeter, ki je opredeljena kot celokupni bilirubin ≤ 1,5 × zgornja meja normale (ZMN) in vrednost aspartat-aminotransferaze (AST)/alanin-aminotransferaze (ALT) ≤ 2,5 × ZMN, prilagajanje začetnega odmerka ni potrebno (glejte poglavje 5.2).
Talk to your doctor, pharmacist or nurse before using BESPONSA if you:
Pred začetkom uporabe zdravila BESPONSA se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če:
In the pivotal study (N=164), thrombocytopenia and neutropenia were reported in 83 (51%) and 81 (49%) patients, respectively.
V ključnem preskušanju (n = 164) so o trombocitopeniji oziroma nevtropeniji poročali pri 83 (51 %) oziroma 81 (49 %) bolnikih.
BESPONSA is a powder for concentrate for solution for infusion.
Zdravilo BESPONSA je prašek za koncentrat za raztopino za infundiranje.
- Patients who have experienced prior confirmed severe or ongoing venoocclusive liver disease/sinusoidal obstruction syndrome (VOD/SOS).
- Bolniki s potrjeno hudo venookluzivno boleznijo jeter/sindromom obstrukcije sinusoidov (VOD/SOS - Veno-Occlusive Liver Disease/Sinusoidal Obstruction Syndrome) v anamnezi ali ki imajo VOD/SOS.
Grade 3 thrombocytopenia and neutropenia were reported in 23 (14%) and 33 (20%) patients, respectively.
O trombocitopeniji oziroma nevtropeniji stopnje 3 so poročali pri 23 (14 %) oziroma 33 (20 %) bolnikih.
In toxicity studies, rats developed oval cell hyperplasia, altered hepatocellular foci, and hepatocellular adenomas in the liver at approximately 0.3 times the human clinical exposure based on AUC.
V preskušanjih toksičnosti so se pri podganah pri približno 0,3-kratniku klinične izpostavljenosti pri ljudeh na podlagi vrednosti AUC razvili hiperplazija ovalnih celic, spremenjena hepatocelična žarišča in hepatocelični adenomi v jetrih.
BESPONSA should not be administered as an intravenous push or bolus.
Zdravila BESPONSA ne smete dajati kot hitro intravensko infuzijo ali bolus.
In patients receiving inotuzumab ozogamicin, QT interval prolongation was observed (see sections 4.8 and 5.2).
Pri bolnikih, ki so prejemali inotuzumab ozogamicin, so opazili podaljšanje intervala QT (glejte poglavji 4.8 in 5.2).
IV infusion after reconstitution and dilution.
IV infuzija po rekonstituciji in redčenju Samo za enkratno uporabo.
Patients may experience fatigue during treatment with BESPONSA (see section 4.8).
Pri bolnikih se lahko med zdravljenjem z zdravilom BESPONSA pojavi utrujenost (glejte poglavje 4.8).
If the diluted solution is stored in a refrigerator (2 °C-8 °C), bring it to room temperature (20 °C-25 °C) for approximately 1 hour prior to administration.
Če razredčeno raztopino hranite v hladilniku (2 °C - 8 °C), jo približno 1 uro pred uporabo prenesite na sobno temperaturo (20 °C - 25 °C).
Headache (28%)
Bolezni živčevja glavobol (28 %)
In patients receiving inotuzumab ozogamicin, infusion related reactions were reported (see section 4.8).
Pri bolnikih, ki so prejemali inotuzumab ozogamicin, so poročali o reakcijah, povezanih z infuzijo (glejte poglavje 4.8).
There was a trend in favour of BESPONSA, improvement grade small, for estimated mean postbaseline scores (BESPONSA and Investigator's choice, respectively) in global health status/Quality of Life (QoL) (62.1 versus 57.8), cognitive functioning (85.3 versus 82.5), dyspnoea (14.7 versus 19.4), diarrhoea (5.9 versus 8.9), fatigue (35.0 versus 39.4).
Prisoten je bil trend v korist zdravila BESPONSA, in sicer izboljšanje nizke stopnje pri ocenjenih povprečnih rezultatih od izhodišča (zdravilo BESPONSA v primerjavi z izbiro raziskovalca) glede splošnega zdravstvenega stanja/kakovosti življenja (QoL - Quality of Life) (62,1 v primerjavi s 57,8), kognitivnega delovanja (85,3 v primerjavi z 82,5), dispneje (14,7 v primerjavi z 19,4), diareje (5,9 v primerjavi z 8,9) in utrujenosti (35,0 v primerjavi z 39,4).
Hypersensitivity (1%)
Bolezni imunskega sistema preobčutljivost (1 %)
For severe or life-threatening infusion reactions, permanently discontinue treatment (see section 4.4).
Pri resnih ali življenjsko ogrožajočih reakcijah na infuzijo zdravljenje trajno prekinite (glejte poglavje 4.4).
These medicines are called antineoplastic agents.
Ta zdravila se imenujejo zdravila z delovanjem na novotvorbe.
[4.7 to 8.3] Hazard ratio [95% CI] = 0.751 [0.588-0.959] 2-sided p-value = 0.0210
razmerje ogroženosti (95 % IZ) = 0,751 (0,588-0,959) 2-stranska vrednost p = 0,0210
Myelosuppression/cytopenias
Mielosupresija/citopenije
Adverse reactions reported in patients with relapsed or refractory B-cell precursor ALL who received BESPONSA
Neželeni učinki, o katerih so poročali pri bolnikih z recidivno ali refraktarno prekurzorsko B-celično ALL, ki so prejemali zdravilo BESPONSA
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION BESPONSA 1 mg Powder for concentrate inotuzumab ozogamicin For IV infusion after reconstitution and dilution.
BESPONSA 1 mg prašek za koncentrat inotuzumab ozogamicin Za IV infuzijo po rekonstituciji in redčenju.
Of the 49 (15%) patients with Ph+ ALL, 4 patients did not receive a prior TKI, 28 patients received 1 prior TKI, and 17 patients received 2 prior TKIs.
+ ALL 4 bolniki niso prejeli predhodnega TKI, 28 jih je prejelo en predhodni TKI in 17 jih je prejelo 2 predhodna TKI.
In patients receiving inotuzumab ozogamicin, prolonged QT interval was observed (see section 4.4).
Pri bolnikih, ki so prejemali inotuzumab ozogamicin, so opazili podaljšanje intervala QT (glejte poglavje 4.4).
There is limited safety information available in patients with total bilirubin > 1.5 × ULN and AST/ALT > 2.5 × ULN prior to dosing.
Za bolnike s celokupnim bilirubinom > 1,5 × ZMN in vrednostjo AST/ALT > 2,5 × ZMN pred odmerjanjem so na voljo le omejeni podatki o varnosti.
Your doctor will take regular blood tests to monitor your blood counts during treatment with BESPONSA.
Zdravnik bo med zdravljenjem z zdravilom BESPONSA opravljal redne preiskave krvi za spremljanje vaše krvne slike.
In patients receiving inotuzumab ozogamicin, increases in amylase and lipase have been reported (see section 4.8).
Pri bolnikih, ki so prejemali inotuzumab ozogamicin, so poročali o zvečanih vrednostih amilaze in lipaze (glejte poglavje 4.8).
Grade 3/4 bleeding/haemorrhagic events were reported in 8/164 (5%) patients.
O krvavitvah stopnje 3/4 so poročali pri 8/164 (5 %) bolnikov.
If the reconstituted solution cannot be used immediately, it may be stored in a refrigerator (2 °C-8 °C) for up to 4 hours.
Če rekonstituirane raztopine ne morete uporabiti takoj, jo lahko hranite v hladilniku (2 °C - 8 °C) največ 4 ure.
- Use immediately or store in a refrigerator (2 °C-8 °C) for up to 4 hours.
- Uporabite jo takoj ali jo hranite v hladilniku (2 °C - 8 °C) največ 4 ure.
- Store in a refrigerator (2 °C-8 °C).
- Shranjujte v hladilniku (2 °C - 8 °C).
Among the initial 218 randomised patients, 64/88 (73%) and 21/88 (24%) of responding patients per EAC achieved a CR/CRi in Cycles 1 and 2, respectively, in the BESPONSA arm. No additional patients achieved CR/CRi after Cycle 3 in the BESPONSA arm.
Od prvotnih 218 randomiziranih bolnikov je v skupini, ki so jo zdravili z zdravilom BESPONSA, CR/CRi v 1. oziroma 2. ciklu doseglo 64/88 (73 %) oziroma 21/88 (24 %) bolnikov.
Signs and symptoms of VOD/SOS should be monitored closely in all patients, especially post HSCT.
Vse bolnike, zlasti po PKMC, je treba skrbno spremljati glede znakov in simptomov VOD/SOS.
Re-initiation of BESPONSA at the correct therapeutic dose should be considered when all toxicities have resolved.
Ko vsi toksični učinki izzvenijo, je treba razmisliti o ponovni uvedbi zdravila BESPONSA s pravilnim terapevtskim odmerkom.
N-acetyl-gamma-calicheamicin is covalently attached to the antibody via an acid-cleavable linker.
N-acetil-gama-kaliheamicin je na protitelo kovalentno vezan preko povezovalca, katerega cepitev je kislinsko sprožena.
[2.8 to 4.6] Hazard ratio [95% CI] = 0.471 [0.366-0.606] 2-sided p-value < 0.0001
razmerje ogroženosti (95 % IZ) = 0,471 (0,366-0,606) 2-stranska vrednost p < 0,0001
For clinical management of infections, see section 4.4.
Za klinično obvladovanje okužb glejte poglavje 4.4.
Inotuzumab ozogamicin is an ADC composed of a CD22-directed monoclonal antibody that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.
Inotuzumab ozogamicin je ADC, sestavljen iz monoklonskega protitelesa, ki je usmerjeno proti CD22 in kovalentno vezano na N-acetil-gama-kaliheamicin dimetilhidrazid.
• have signs and symptoms of an infusion related reaction, such as fever and chills or breathing problems during or shortly after the BESPONSA infusion.
• imate med infundiranjem zdravila BESPONSA ali kmalu po njem znake in simptome z infuzijo povezane reakcije, kot sta vročina in mrzlica ali težave z dihanjem.