natgillin/translations-raw huggingface dataset:
Further information on Zynteglo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zynteglo.
Nadaljnje informacije o zdravilu Zynteglo so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/zynteglo.
As a result, these patients have low red blood cell levels and need frequent blood transfusions.
Zato imajo ti bolniki nizke ravni rdečih krvnih celic in potrebujejo pogoste transfuzije krvi.
Although information on the safety of the medicine is limited because of the small number of patients treated to date and the lack of long-term data, the European Medicines Agency decided that Zynteglo's benefits are greater than its risks and it can be authorised for use in the EU.
Čeprav so informacije o varnosti zdravila omejene zaradi majhnega števila zdravljenih bolnikov doslej in pomanjkanja dolgoročnih podatkov, je Evropska agencija za zdravila zaključila, da so koristi zdravila Zynteglo večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Patients will also receive a guide and a card that they should carry with them.
Bolniki bodo prejeli tudi vodnik in opozorilno kartico, ki jo morajo imeti vedno pri sebi.
An overview of Zynteglo and why it is authorised in the EU
Pregled zdravila Zynteglo in zakaj je odobreno v EU
This means that the patients can avoid the excessive build-up of iron that occurs with regular transfusions and which itself requires treatment.
To pomeni, da se lahko bolniki izognejo prenasičenosti z železom, ki nastane zaradi kroničnih transfuzij in ki sama po sebi zahteva zdravljenje.
Regarding safety, because Zynteglo is produced using a virus, there could be a theoretical risk of cancer caused by unintended changes in the genetic material, although no such cases have been seen so far.
Ker se zdravilo Zynteglo izdela s pomočjo virusa, obstaja z vidika varnosti teoretično tveganje za nastanek raka zaradi nenačrtovanih sprememb genskega materiala, čeprav do zdaj tovrstnih primerov niso opazili.
There is also a potential risk of bleeding since the medicine may cause a drop in platelets.
Poleg tega obstaja možno tveganje za krvavitve, saj lahko zdravilo povzroči padec ravni trombocitov.
As for all medicines, data on the use of Zynteglo are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Zynteglo stalno spremljajo.
Other information about Zynteglo
Druge informacije o zdravilu Zynteglo
Why is Zynteglo authorised in the EU?
Zakaj je bilo zdravilo Zynteglo odobreno v EU?
The company that markets Zynteglo will provide educational materials for healthcare professionals expected to use the medicine with information on its safety, including the potential risks of cancer and bleeding, and how it should be given.
Podjetje, ki trži zdravilo Zynteglo, bo priskrbelo izobraževalno gradivo za zdravstvene delavce, ki naj bi uporabljali zdravilo, ki bo vsebovalo informacije o njegovi varnosti, vključno z morebitnimi tveganji za nastanek raka in krvavitev, in načinu njegovega dajanja.
Side effects reported with Zynteglo are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Zynteglo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What is Zynteglo and what is it used for?
Kaj je zdravilo Zynteglo in za kaj se uporablja?
Doctors should consider whether patients can be given the required pre-treatments needed before Zynteglo.
Zdravniki morajo proučiti, ali lahko bolniki pred zdravljenjem z zdravilom Zynteglo prejmejo predhodno pripravljalno zdravljenje.
Beta thalassaemia is rare, and Zynteglo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 24 January 2013.
Beta talasemija je redka bolezen, zato je bilo zdravilo Zynteglo 24. januarja 2013 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
In these studies, out of the 14 patients who did not completely lack beta-globin and were given Zynteglo, 11 of them had sufficiently high levels of red blood cells so that they did not need blood transfusions for at least 1 year after treatment.
V teh študijah je imelo izmed 14 bolnikov, ki jim ni v celoti primanjkovalo beta-globina in so prejemali zdravilo Zynteglo, 11 bolnikov dovolj visoke ravni rdečih krvnih celic, tako da vsaj eno leto po zdravljenju niso potrebovali transfuzije krvi.
It is given as an infusion (drip) into a vein and the dose depends on the bodyweight of the patient.
Daje se z infundiranjem (kapalno infuzijo) v veno, odmerek pa je odvisen od telesne mase bolnika.
Zynteglo must not be used in pregnant or breastfeeding women, and in patients who have previously had gene therapy treatment (medicine that delivers genes).
Zdravilo Zynteglo se ne sme uporabljati pri nosečnicah ali ženskah, ki dojijo, ter pri bolnikih, ki so v preteklosti že bili zdravljeni z genskim zdravljenjem (zdravilom, ki prenese gene v telo).
Transfusion-dependent beta thalassaemia is a severe condition for which treatment options are limited.
Od transfuzije odvisna beta talasemija je huda bolezen, za katero so na voljo omejene možnosti zdravljenja.
What benefits of Zynteglo have been shown in studies?
Kakšne koristi zdravila Zynteglo so se pokazale v študijah?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zynteglo have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Zynteglo upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Zynteglo has been given ‘conditional authorisation'.
Zdravilo Zynteglo je pridobilo „pogojno dovoljenje za promet“.
For more information about using Zynteglo, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Zynteglo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The company will also provide data from a registry of patients treated with Zynteglo to study its longterm safety and effectiveness, as well as further data on the tests used in the manufacturing of the medicine to ensure its quality.
Hkrati bo predložilo podatke iz registra bolnikov, ki se zdravijo z zdravilom Zynteglo, s pomočjo katerih bo proučilo dolgoročno varnost in učinkovitost zdravila, ter dodatne podatke o testih, ki se uporabljajo pri proizvodnji zdravila, da se zagotovi njegova kakovost.
What are the risks associated with Zynteglo?
Kakšna tveganja so povezana z zdravilom Zynteglo?
When these modified cells are given back to the patient, they are transported in the bloodstream to the bone marrow where they start to make healthy red blood cells that produce beta-globin.
Ko se te spremenjene celice vrnejo bolniku, se prenesejo iz krvnega obtoka v krvni mozeg, kjer začnejo proizvajati zdrave rdeče krvne celice, ki tvorijo beta-globin.
Studies show that with a one-time treatment with Zynteglo most patients no longer need blood transfusions to increase their levels of working red blood cells.
Študije kažejo, da večina bolnikov z enkratnim zdravljenjem z zdravilom Zynteglo ne potrebuje več transfuzije krvi, da bi povečali svojo raven delujočih rdečih krvnih celic.
Zynteglo is made individually for each patient out of stem cells collected from their blood, and must only be given to the patient for whom it is made.
Zdravilo Zynteglo je izdelano za vsakega bolnika posebej iz matičnih celic, pridobljenih iz njihove krvi, zato se mora dajati samo tistemu bolniku, za katerega je bilo izdelano.
People with this genetic condition cannot make enough beta-globin, a component of haemoglobin, the protein in red blood cells that carries oxygen around the body.
Ljudje s to genetsko boleznijo ne morejo proizvajati dovolj beta-6globina, sestavine hemoglobina, tj. beljakovine v rdečih krvnih celicah, ki prenaša kisik po telesu.
The effects of Zynteglo are expected to last for the patient's lifetime.
Pričakovano je, da učinki zdravila Zynteglo trajajo vse bolnikovo življenje.
Since Zynteglo has been given conditional authorisation, the company that markets Zynteglo will provide results of ongoing studies to further assess the effectiveness and safety of the medicine.
Ker je zdravilo Zynteglo pridobilo pogojno dovoljenje za promet, bo podjetje, ki ga trži, zagotovilo rezultate potekajočih študij, s pomočjo katerih bo dodatno ocenilo učinkovitost in varnost zdravila.
Zynteglo is used in patients who do not completely lack beta-globin and who are eligible for stem cell transplantation but do not have a matching related donor.
Zdravilo Zynteglo se uporablja pri bolnikih, ki niso povsem brez beta globina in so primerni za presaditev matičnih celic, vendar nimajo ustreznega darovalca.
Zynteglo is a medicine used to treat a blood disorder known as beta thalassaemia in patients 12 years and older who require regular blood transfusions.
Zynteglo je zdravilo, ki se uporablja za zdravljenje krvnih motenj, znanih kot beta talasemija, pri bolnikih, starih 12 let in več, ki potrebujejo redno transfuzijo krvi.
Zynteglo contains as its active substance stem cells taken from the patients that have been genetically modified to contain a working gene for beta-globin.
Zdravilo Zynteglo vsebuje kot učinkovino matične celice bolnikov, ki so bile genetsko spremenjene tako, da vsebujejo delujoči gen za beta globin.
What information is still awaited for Zynteglo?
Katere informacije o zdravilu Zynteglo še pričakujemo?
Before Zynteglo is given, the patient will receive conditioning chemotherapy treatment to clear their bone marrow of cells.
Pred zdravljenjem z zdravilom Zynteglo bo bolnik prejel pripravljalno zdravljenje s kemoterapijo za odstranitev celic kostnega mozga.
Zynteglo can only be obtained with a prescription and must be given in an approved centre by a doctor experienced in stem cell transplantation and in the treatment of beta thalassaemia.
Predpisovanje in izdaja zdravila Zynteglo je le na recept, daje pa ga lahko samo zdravnik z izkušnjami s presaditvijo matičnih celic in zdravljenjem beta talasemije v specializirani zdravstveni ustanovi.
A small number of patients have been treated with Zynteglo to date, and the most serious side effect observed is thrombocytopenia (low blood levels of platelets, components that help the blood to clot).
Najresnejši opaženi neželeni učinek je trombocitopenija (nizka raven trombocitov, sestavine v krvi, ki sodeluje pri strjevanju krvi).
How is Zynteglo used?
Kako se zdravilo Zynteglo uporablja?
To make Zynteglo, the stem cells taken from the patient's blood are modified by a virus that carries working copies of the beta-globin gene into the cells.
Za izdelavo zdravila Zynteglo se matične celice, odvzete iz bolnikove krvi, spremenijo s pomočjo virusa, ki v celice vnese delujoče kopije beta-globina.
How does Zynteglo work?
Kako zdravilo Zynteglo deluje?
Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) EMA/205979/2019
Zynteglo (avtologne celice CD34+, ki kodirajo gen za βA
Zynteglo has been shown to be effective at reducing the need for blood transfusion in 2 main studies in patients with beta thalassaemia who required regular blood transfusions.
V dveh glavnih študijah pri bolnikih z beta talasemijo, ki so potrebovali redne transfuzije krvi, je bilo dokazano, da je zdravilo Zynteglo učinkovito pri zmanjševanju potrebe po transfuziji krvi.
The following information is intended for healthcare professionals only.
Naslednje informacije so namenjene samo zdravstvenim delavcem.
< 7 days (within a cycle)
< 7 dni (v enem ciklu)
Date of first authorisation: 29 June 2017
Datum prve odobritve: 29. junij 2017
The infusion must be administered over 1 hour.
Infuzijo je treba dajati v času 1 ure.
The reconstituted solution must be used immediately.
Rekonstituirano raztopino je treba uporabiti takoj.
All events were Grade ≤ 2 in severity.
Vsi dogodki so bili stopnje resnosti ≤ 2.
BESPONSA should not to be used in children and adolescents under 18 years of age because no data are available in this population.
Zdravila BESPONSA ne smemo uporabljati pri otrocih in mladostnikih, mlajših od 18 let, saj podatki za to populacijo niso razpoložljivi.
This procedure may take place if your disease responds completely to treatment.
Ta postopek lahko opravijo, če se vaša bolezen v celoti odzove na zdravljenje.
• Reduction in the number of various types of blood cells
• zmanjšanje števila različnih vrst krvnih celic
United States (USA)
Združene države Amerike (ZDA)
a Infection also includes other types of infection (11%).
Okužba vključuje tudi druge vrste okužb (11 %).
Most effects were reversible to partially reversible except for effects in the liver and nervous system.
Večina učinkov je bila reverzibilnih do delno reverzibilnih, razen učinkov na jetra in živčni sistem.
Subsequent cycles are 4 weeks in duration.
Ti cikli trajajo 4 tedne.
The safety and efficacy of BESPONSA in children aged 0 to <18 years have not been established.
Varnost in učinkovitost zdravila BESPONSA pri otrocih, starih od 0 do < 18 let, nista bili dokazani.
Note: patients may have had > 1 type of infection.
Opomba: bolniki so lahko imeli > 1 vrsto okužbe.
The final concentration should be between 0.01 and 0.1 mg/mL.
Končna koncentracija mora biti od 0,01 do 0,1 mg/ml.
Preferred terms were retrieved by applying the Medical Dictionary for Regulatory Activities (MedDRA) version 19.1.
Priporočene izraze so pridobili z uporabo medicinskega slovarja za regulatorne aktivnosti (MedDRA - Medical Dictionary for Regulatory Activities), različica 19.1.
You should not use BESPONSA during pregnancy, unless your doctor thinks that it is the best medicine for you.
Zdravila BESPONSA ne uporabljajte med nosečnostjo, razen če zdravnik meni, da je to najboljše zdravilo za vas.
Tell your doctor immediately if you have signs and symptoms of any of the following serious side effects:
Nemudoma obvestite zdravnika, če imate znake in simptome katerega od naslednjih resnih neželenih učinkov:
Omit the next dose within the cycle.
Izpustite naslednji odmerek v ciklu.
What BESPONSA is and what it is used for 2.
Kaj je zdravilo BESPONSA in za kaj ga uporabljamo 2.
e 7-day treatment-free interval starting on Day 21.
7-dnevni interval brez zdravljenja, ki se začne 21. dan.
Therefore, caution is recommended when driving or operating machines.
Zato je med vožnjo ali upravljanjem strojev priporočljiva previdnost.
Do not use BESPONSA if you:
Ne uporabljajte zdravila BESPONSA, če:
The 2 treatment groups were generally balanced with respect to the baseline demographics and disease characteristics.
Obe zdravljeni skupini sta bili na splošno uravnoteženi z vidika izhodiščnih demografskih značilnosti in značilnosti bolezni.
you may receive 2 cycles or a maximum of 3 cycles of treatment.
lahko prejmete 2 cikla ali največ 3 cikle zdravljenja.
BESPONSA should be administered in 3- to 4-week cycles.
Zdravilo BESPONSA je treba dajati v 3- do 4-tedenskih ciklih.
• Filtration of the diluted solution is not required.
• Filtriranje razredčene raztopine ni potrebno.
• are allergic to inotuzumab ozogamicin or any of the other ingredients of this medicine (listed in section 6).
• ste alergični na inotuzumab ozogamicin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
Of the 326 patients (ITT population), 253 patients had samples that were evaluable for CD22 testing by both local and central laboratory.
Od 326 bolnikov (populacija ITT) je 253 bolnikov imelo vzorce, ki so bili ocenljivi za preskus za CD22 tako v lokalnem kot tudi v centralnem laboratoriju.
Dasatinib was the most commonly received TKI (42 patients) followed by imatinib (24 patients).
Najpogosteje prejeti TKI je bil dasatinib (42 bolnikov), sledil mu je imatinib (24 bolnikov).
Do not use filters made of nylon or mixed cellulose ester (MCE).
Ne uporabljajte filtrov, izdelanih iz najlona ali estra mešane celuloze (MCE - Mixed Cellulose Ester).
• If you do not respond to the medicine within 3 cycles, your treatment will be stopped.
• Če se na zdravilo ne odzovete v 3 ciklih, bo zdravljenje ukinjeno.
• Calculate the dose (mg) and number of vials of BESPONSA required.
• Izračunajte odmerek (mg) in število vial zdravila BESPONSA, ki jih potrebujete.
The infusion line does not need to be protected from light.
Infuzijskega sistema ni treba zaščiti pred svetlobo.
Dose modifications for haematological toxicities at the start of a treatment cycle (Day 1)
Prilagoditve odmerkov za hematološke toksičnosti na začetku cikla zdravljenja (1. dan)
Some of these side effects may be serious.
Nekateri neželeni učinki so lahko resni.
There are no data on the presence of inotuzumab ozogamicin or its metabolites in human milk, the effects on the breast-fed child, or the effects on milk production.
Ni podatkov o prisotnosti inotuzumab ozogamicina ali njegovih presnovkov v materinem mleku, učinkih na dojene otroke ali učinkih na nastajanje mleka.
A stem cell transplant is a procedure to transplant another person's stem cells (cells which develop into new blood cells) into your bloodstream.
Presaditev matičnih celic je postopek, pri katerem v vaš krvni obtok presadijo matične celice (celice, ki se razvijejo v nove krvne celice) druge osebe.
• A doctor or nurse will give you BESPONSA through a drip in your vein (intravenous infusion) which will run for 1 hour.
• Zdravnik ali medicinska sestra vam bosta postopoma dajala zdravilo BESPONSA kapalno v veno (intravenska infuzija), kar bo trajalo 1 uro.
a Platelet count used for dosing must be independent of blood transfusion.
Število trombocitov, ki jih uporabimo za odmerjanje, mora biti neodvisno od transfuzije krvi.
• Changes in heart rhythm (may show on electrocardiogram)
• spremembe srčnega ritma (lahko se pokažejo na elektrokardiogramu)
Acute lymphoblastic leukaemia is a cancer of blood where you have too many white blood cells.
Akutna limfoblastna levkemija je krvni rak, pri katerem ima bolnik preveč belih krvnih celic.
• Each dose is given weekly and each treatment cycle is 3 doses.
• Vsak odmerek boste prejeli tedensko, en cikel zdravljenja pa obsega 3 odmerke.
Table 1 (see section 4.2) shows the dosing regimen used to treat patients.
Preglednica 1 (glejte poglavje 4.2) prikazuje režim odmerjanja za zdravljenje bolnikov.
There is no information on fertility in patients.
Podatkov o plodnosti pri bolnikih ni.
BESPONSA should be administered under the supervision of a physician experienced in the use of cancer therapy and in an environment where full resuscitation facilities are immediately available.
Zdravilo BESPONSA je treba uporabljati pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil za zdravljenje rakavih obolenj, in v okolju, kjer je nemudoma na voljo vsa oprema za reanimacijo.
• Your doctor may change your dose, interrupt, or completely stop treatment with BESPONSA
• Zdravnik lahko spremeni odmerek, prekine ali popolnoma ukini zdravljenje z zdravilom
If severe VOD/SOS occurs, the patient should be treated according to standard medical practice.
Če se pojavi huda VOD/SOS, je treba bolnika zdraviti v skladu z običajno medicinsko prakso.
Table 6 shows the efficacy results from this study.
Preglednica 6 prikazuje rezultate učinkovitosti iz te študije.
A total of 276 (85%) patients had Ph- ALL.
Skupno 276 (85 %) bolnikov je imelo Ph ALL.
If you feel unusually tired (this is a very common side effect of BESPONSA), you should not drive or use machines.
Če se počutite neobičajno utrujeni, kar je zelo pogost neželeni učinek zdravila BESPONSA, ne upravljajte vozil ali strojev.
> 28 days
> 28 dni
≥ 14 days
≥ 14 dni
Five of the 18 VOD/SOS events that occurred post-HSCT were fatal (see section 5.1).
5 od 18 primerov VOD/SOS, ki so se pojavili po PKMC, je bilo smrtnih (glejte poglavje 5.1).
What you need to know before you are given BESPONSA 3.
Kaj morate vedeti, preden boste prejeli zdravilo BESPONSA 3.
Analysis was based on the ITT population with patients without remission being given a duration of zero and considered an event.
Analiza je temeljila na populaciji ITT z bolniki brez remisije, ki so jih obravnavali kot dogodek s trajanjem nič.
BESPONSA has moderate influence on the ability to drive and use machines.
Zdravilo BESPONSA ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Each pack of BESPONSA contains:
Eno pakiranje zdravila BESPONSA vsebuje:
b For patients who achieve a CR/CRi, and/or to allow for recovery from toxicity, the cycle length may be extended up to 28 days (i.e. 7-day treatment-free interval starting on Day 21).
Pri bolnikih, ki dosežejo CR/CRi, in/ali da omogočite okrevanje od toksičnosti, lahko dolžino cikla podaljšate na največ 28 dni (tj. 7-dnevni interval brez zdravljenja, ki se začne 21. dan).
The number of patients was too small to assess the impact of anti-inotuzumab ozogamicin antibodies on efficacy and safety.
Število bolnikov je bilo premajhno, da bi lahko ocenili vpliv protiteles proti inotuzumab ozogamicinu na učinkovitost in varnost.
This condition may occur during treatment with BESPONSA or after subsequent treatment with a stem cell transplant.
To stanje se lahko pojavi med zdravljenjem z zdravilom BESPONSA ali po nadaljnjem zdravljenju s presaditvijo matičnih celic.
If the dose is reduced due to BESPONSA-related toxicity, the dose should not be re-escalated.
Če ste odmerek zmanjšali zaradi toksičnosti, povezane z zdravilom BESPONSA, ga ne smete ponovno zvečati.
No Grade ≥ 3 QT interval prolongation or events of Torsades de Pointes were reported.
O podaljšanju intervala QT stopnje ≥ 3 ali dogodkih Torsades de pointes niso poročali.
BESPONSA is for intravenous use.
Zdravilo BESPONSA je za intravensko uporabo.
Table 7 shows the efficacy results from this study.
Preglednica 7 prikazuje rezultate učinkovitosti iz te študije.
Once adequate recovery is achieved, decrease the total dose by 25% for the subsequent cycle.
Ko dosežete ustrezno izboljšanje, zmanjšajte celokupni odmerek pri naslednjem ciklu za 25 %.
What BESPONSA is and what it is used for
Kaj je zdravilo BESPONSA in za kaj ga uporabljamo
Tell your doctor if you have symptoms, such as dizziness, lightheadedness or fainting.
Obvestite zdravnika, če se vam pojavijo simptomi, kot so omotica, vrtoglavica ali omedlevica.
The median time from HSCT to onset of VOD/SOS was 15 days (range: 3-57 days).
Mediani čas od PKMC do pojava VOD/SOS je bil 15 dni (razpon: 3-57 dni).
≥ 7 days
≥ 7 dni
For full information on dosage and dose modifications please refer to the Summary of Product Characteristics.
Za celotne informacije glede odmerjanja in prilagajanja odmerkov glejte Povzetek glavnih značilnosti zdravila.
This is consistent with the known induction of DNA breaks by calicheamicin.
To je skladno z znano indukcijo pretrganja DNK s kaliheamicinom.
If a 25% decrease in the total dose followed by a decrease to 2 doses per cycle is not tolerated, then permanently discontinue treatment.
Če bolnik ne prenaša 25-odstotnega zmanjšanja celokupnega odmerka, ki mu sledi zmanjšanje na 2 odmerka na cikel, zdravljenje trajno prekinite.
The reconstituted solution must be clear to slightly cloudy, colourless, and essentially free of visible foreign matter.
Rekonstituirana raztopina mora biti bistra do rahlo motna, brezbarvna in praktično brez vidnih tujih delcev.
• Raised bilirubin level which may result in a yellowish colour in the skin, eyes, and other tissues
• zvečana raven bilirubina, kar lahko povzroči rumenkasto obarvanje kože, oči in drugih tkiv
If further dose modification is required, then reduce the number of doses to 2 per cycle for subsequent cycles.
Če je potrebno nadaljnje prilagajanje odmerka, zmanjšajte število odmerkov pri naslednjih ciklih na 2 na cikel.
Cycle 1 is 3 weeks in duration but may be extended to 4 weeks if the patient achieves a CR or CRi, and/or to allow recovery from toxicity.
Prvi cikel traja 3 tedne, vendar ga lahko podaljšamo na 4 tedne, če bolnik doseže CR ali CRi in/ali da omogočite okrevanje od toksičnosti.
Do not mix BESPONSA or administer as an infusion with other medicinal products.
Zdravila BESPONSA ne smemo mešati ali dajati kot infuzijo z drugimi zdravili.