FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Zdravilo Zynteglo vsebuje kot učinkovino matične celice bolnikov, ki so bile genetsko spremenjene tako, da vsebujejo delujoči gen za beta globin.
English: What information is still awaited for Zynteglo?
Slovenian: Katere informacije o zdravilu Zynteglo še pričakujemo?
English: Before Zynteglo is given, the patient will receive conditioning chemotherapy treatment to clear their bone marrow of cells.
Slovenian: Pred zdravljenjem z zdravilom Zynteglo bo bolnik prejel pripravljalno zdravljenje s kemoterapijo za odstranitev celic kostnega mozga.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: Najresnejši opaženi neželeni učinek je trombocitopenija (nizka raven trombocitov, sestavine v krvi, ki sodeluje pri strjevanju krvi).
English: How is Zynteglo used?
Slovenian: Kako se zdravilo Zynteglo uporablja?
English: 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.
Slovenian: Za izdelavo zdravila Zynteglo se matične celice, odvzete iz bolnikove krvi, spremenijo s pomočjo virusa, ki v celice vnese delujoče kopije beta-globina.
English: How does Zynteglo work?
Slovenian: Kako zdravilo Zynteglo deluje?
English: Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) EMA/205979/2019
Slovenian: Zynteglo (avtologne celice CD34+, ki kodirajo gen za βA
English: 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.
Slovenian: 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.
English: The following information is intended for healthcare professionals only.
Slovenian: Naslednje informacije so namenjene samo zdravstvenim delavcem.
English: < 7 days (within a cycle)
Slovenian: < 7 dni (v enem ciklu)
English: Date of first authorisation: 29 June 2017
Slovenian: Datum prve odobritve: 29. junij 2017
English: B-1930, Zaventem Belgium
Slovenian: B-1930, Zaventem Belgija
English: The infusion must be administered over 1 hour.
Slovenian: Infuzijo je treba dajati v času 1 ure.
English: The reconstituted solution must be used immediately.
Slovenian: Rekonstituirano raztopino je treba uporabiti takoj.
English: All events were Grade ≤ 2 in severity.
Slovenian: Vsi dogodki so bili stopnje resnosti ≤ 2.
English: BESPONSA should not to be used in children and adolescents under 18 years of age because no data are available in this population.
Slovenian: Zdravila BESPONSA ne smemo uporabljati pri otrocih in mladostnikih, mlajših od 18 let, saj podatki za to populacijo niso razpoložljivi.
English: This procedure may take place if your disease responds completely to treatment.
Slovenian: Ta postopek lahko opravijo, če se vaša bolezen v celoti odzove na zdravljenje.
English: • Reduction in the number of various types of blood cells
Slovenian: • zmanjšanje števila različnih vrst krvnih celic
English: United States (USA)
Slovenian: Združene države Amerike (ZDA)
English: a Infection also includes other types of infection (11%).
Slovenian: Okužba vključuje tudi druge vrste okužb (11 %).
English: Most effects were reversible to partially reversible except for effects in the liver and nervous system.
Slovenian: Večina učinkov je bila reverzibilnih do delno reverzibilnih, razen učinkov na jetra in živčni sistem.
English: Subsequent cycles are 4 weeks in duration.
Slovenian: Ti cikli trajajo 4 tedne.
English: The safety and efficacy of BESPONSA in children aged 0 to <18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila BESPONSA pri otrocih, starih od 0 do < 18 let, nista bili dokazani.
English: Note: patients may have had > 1 type of infection.
Slovenian: Opomba: bolniki so lahko imeli > 1 vrsto okužbe.
English: The final concentration should be between 0.01 and 0.1 mg/mL.
Slovenian: Končna koncentracija mora biti od 0,01 do 0,1 mg/ml.
English: Preferred terms were retrieved by applying the Medical Dictionary for Regulatory Activities (MedDRA) version 19.1.
Slovenian: Priporočene izraze so pridobili z uporabo medicinskega slovarja za regulatorne aktivnosti (MedDRA - Medical Dictionary for Regulatory Activities), različica 19.1.
English: You should not use BESPONSA during pregnancy, unless your doctor thinks that it is the best medicine for you.
Slovenian: Zdravila BESPONSA ne uporabljajte med nosečnostjo, razen če zdravnik meni, da je to najboljše zdravilo za vas.
English: Tell your doctor immediately if you have signs and symptoms of any of the following serious side effects:
Slovenian: Nemudoma obvestite zdravnika, če imate znake in simptome katerega od naslednjih resnih neželenih učinkov:
English: Omit the next dose within the cycle.
Slovenian: Izpustite naslednji odmerek v ciklu.
English: What BESPONSA is and what it is used for 2.
Slovenian: Kaj je zdravilo BESPONSA in za kaj ga uporabljamo 2.
English: e 7-day treatment-free interval starting on Day 21.
Slovenian: 7-dnevni interval brez zdravljenja, ki se začne 21. dan.
English: Therefore, caution is recommended when driving or operating machines.
Slovenian: Zato je med vožnjo ali upravljanjem strojev priporočljiva previdnost.
English: Do not use BESPONSA if you:
Slovenian: Ne uporabljajte zdravila BESPONSA, če:
English: The 2 treatment groups were generally balanced with respect to the baseline demographics and disease characteristics.
Slovenian: Obe zdravljeni skupini sta bili na splošno uravnoteženi z vidika izhodiščnih demografskih značilnosti in značilnosti bolezni.
English: you may receive 2 cycles or a maximum of 3 cycles of treatment.
Slovenian: lahko prejmete 2 cikla ali največ 3 cikle zdravljenja.
English: BESPONSA should be administered in 3- to 4-week cycles.
Slovenian: Zdravilo BESPONSA je treba dajati v 3- do 4-tedenskih ciklih.
English: • Filtration of the diluted solution is not required.
Slovenian: • Filtriranje razredčene raztopine ni potrebno.
English: • are allergic to inotuzumab ozogamicin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • ste alergični na inotuzumab ozogamicin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
English: Of the 326 patients (ITT population), 253 patients had samples that were evaluable for CD22 testing by both local and central laboratory.
Slovenian: 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.
English: Dasatinib was the most commonly received TKI (42 patients) followed by imatinib (24 patients).
Slovenian: Najpogosteje prejeti TKI je bil dasatinib (42 bolnikov), sledil mu je imatinib (24 bolnikov).
English: Do not use filters made of nylon or mixed cellulose ester (MCE).
Slovenian: Ne uporabljajte filtrov, izdelanih iz najlona ali estra mešane celuloze (MCE - Mixed Cellulose Ester).
English: • If you do not respond to the medicine within 3 cycles, your treatment will be stopped.
Slovenian: • Če se na zdravilo ne odzovete v 3 ciklih, bo zdravljenje ukinjeno.
English: • Calculate the dose (mg) and number of vials of BESPONSA required.
Slovenian: • Izračunajte odmerek (mg) in število vial zdravila BESPONSA, ki jih potrebujete.
English: The infusion line does not need to be protected from light.
Slovenian: Infuzijskega sistema ni treba zaščiti pred svetlobo.
English: Dose modifications for haematological toxicities at the start of a treatment cycle (Day 1)
Slovenian: Prilagoditve odmerkov za hematološke toksičnosti na začetku cikla zdravljenja (1. dan)
English: Some of these side effects may be serious.
Slovenian: Nekateri neželeni učinki so lahko resni.
English: 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.
Slovenian: Ni podatkov o prisotnosti inotuzumab ozogamicina ali njegovih presnovkov v materinem mleku, učinkih na dojene otroke ali učinkih na nastajanje mleka.
English: A stem cell transplant is a procedure to transplant another person's stem cells (cells which develop into new blood cells) into your bloodstream.
Slovenian: Presaditev matičnih celic je postopek, pri katerem v vaš krvni obtok presadijo matične celice (celice, ki se razvijejo v nove krvne celice) druge osebe.
English: • A doctor or nurse will give you BESPONSA through a drip in your vein (intravenous infusion) which will run for 1 hour.
Slovenian: • Zdravnik ali medicinska sestra vam bosta postopoma dajala zdravilo BESPONSA kapalno v veno (intravenska infuzija), kar bo trajalo 1 uro.
English: a Platelet count used for dosing must be independent of blood transfusion.
Slovenian: Število trombocitov, ki jih uporabimo za odmerjanje, mora biti neodvisno od transfuzije krvi.
English: • Changes in heart rhythm (may show on electrocardiogram)
Slovenian: • spremembe srčnega ritma (lahko se pokažejo na elektrokardiogramu)
English: Acute lymphoblastic leukaemia is a cancer of blood where you have too many white blood cells.
Slovenian: Akutna limfoblastna levkemija je krvni rak, pri katerem ima bolnik preveč belih krvnih celic.
English: • Each dose is given weekly and each treatment cycle is 3 doses.
Slovenian: • Vsak odmerek boste prejeli tedensko, en cikel zdravljenja pa obsega 3 odmerke.
English: Table 1 (see section 4.2) shows the dosing regimen used to treat patients.
Slovenian: Preglednica 1 (glejte poglavje 4.2) prikazuje režim odmerjanja za zdravljenje bolnikov.
English: There is no information on fertility in patients.
Slovenian: Podatkov o plodnosti pri bolnikih ni.
English: 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.
Slovenian: 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.
English: • Your doctor may change your dose, interrupt, or completely stop treatment with BESPONSA
Slovenian: • Zdravnik lahko spremeni odmerek, prekine ali popolnoma ukini zdravljenje z zdravilom
English: If severe VOD/SOS occurs, the patient should be treated according to standard medical practice.
Slovenian: Če se pojavi huda VOD/SOS, je treba bolnika zdraviti v skladu z običajno medicinsko prakso.
English: Table 6 shows the efficacy results from this study.
Slovenian: Preglednica 6 prikazuje rezultate učinkovitosti iz te študije.
English: A total of 276 (85%) patients had Ph- ALL.
Slovenian: Skupno 276 (85 %) bolnikov je imelo Ph ALL.
English: If you feel unusually tired (this is a very common side effect of BESPONSA), you should not drive or use machines.
Slovenian: Če se počutite neobičajno utrujeni, kar je zelo pogost neželeni učinek zdravila BESPONSA, ne upravljajte vozil ali strojev.
English: > 28 days
Slovenian: > 28 dni
English: ≥ 14 days
Slovenian: ≥ 14 dni
English: Five of the 18 VOD/SOS events that occurred post-HSCT were fatal (see section 5.1).
Slovenian: 5 od 18 primerov VOD/SOS, ki so se pojavili po PKMC, je bilo smrtnih (glejte poglavje 5.1).
English: What you need to know before you are given BESPONSA 3.
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo BESPONSA 3.
English: Analysis was based on the ITT population with patients without remission being given a duration of zero and considered an event.
Slovenian: Analiza je temeljila na populaciji ITT z bolniki brez remisije, ki so jih obravnavali kot dogodek s trajanjem nič.
English: BESPONSA has moderate influence on the ability to drive and use machines.
Slovenian: Zdravilo BESPONSA ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: Each pack of BESPONSA contains:
Slovenian: Eno pakiranje zdravila BESPONSA vsebuje:
English: 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).
Slovenian: 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).
English: The number of patients was too small to assess the impact of anti-inotuzumab ozogamicin antibodies on efficacy and safety.
Slovenian: Število bolnikov je bilo premajhno, da bi lahko ocenili vpliv protiteles proti inotuzumab ozogamicinu na učinkovitost in varnost.
English: This condition may occur during treatment with BESPONSA or after subsequent treatment with a stem cell transplant.
Slovenian: To stanje se lahko pojavi med zdravljenjem z zdravilom BESPONSA ali po nadaljnjem zdravljenju s presaditvijo matičnih celic.
English: If the dose is reduced due to BESPONSA-related toxicity, the dose should not be re-escalated.
Slovenian: Če ste odmerek zmanjšali zaradi toksičnosti, povezane z zdravilom BESPONSA, ga ne smete ponovno zvečati.
English: No Grade ≥ 3 QT interval prolongation or events of Torsades de Pointes were reported.
Slovenian: O podaljšanju intervala QT stopnje ≥ 3 ali dogodkih Torsades de pointes niso poročali.
English: BESPONSA is for intravenous use.
Slovenian: Zdravilo BESPONSA je za intravensko uporabo.
English: Table 7 shows the efficacy results from this study.
Slovenian: Preglednica 7 prikazuje rezultate učinkovitosti iz te študije.
English: Once adequate recovery is achieved, decrease the total dose by 25% for the subsequent cycle.
Slovenian: Ko dosežete ustrezno izboljšanje, zmanjšajte celokupni odmerek pri naslednjem ciklu za 25 %.
English: What BESPONSA is and what it is used for
Slovenian: Kaj je zdravilo BESPONSA in za kaj ga uporabljamo
English: Tell your doctor if you have symptoms, such as dizziness, lightheadedness or fainting.
Slovenian: Obvestite zdravnika, če se vam pojavijo simptomi, kot so omotica, vrtoglavica ali omedlevica.
English: The median time from HSCT to onset of VOD/SOS was 15 days (range: 3-57 days).
Slovenian: Mediani čas od PKMC do pojava VOD/SOS je bil 15 dni (razpon: 3-57 dni).
English: ≥ 7 days
Slovenian: ≥ 7 dni
English: For full information on dosage and dose modifications please refer to the Summary of Product Characteristics.
Slovenian: Za celotne informacije glede odmerjanja in prilagajanja odmerkov glejte Povzetek glavnih značilnosti zdravila.
English: This is consistent with the known induction of DNA breaks by calicheamicin.
Slovenian: To je skladno z znano indukcijo pretrganja DNK s kaliheamicinom.
English: If a 25% decrease in the total dose followed by a decrease to 2 doses per cycle is not tolerated, then permanently discontinue treatment.
Slovenian: Če bolnik ne prenaša 25-odstotnega zmanjšanja celokupnega odmerka, ki mu sledi zmanjšanje na 2 odmerka na cikel, zdravljenje trajno prekinite.
English: The reconstituted solution must be clear to slightly cloudy, colourless, and essentially free of visible foreign matter.
Slovenian: Rekonstituirana raztopina mora biti bistra do rahlo motna, brezbarvna in praktično brez vidnih tujih delcev.
English: • Raised bilirubin level which may result in a yellowish colour in the skin, eyes, and other tissues
Slovenian: • zvečana raven bilirubina, kar lahko povzroči rumenkasto obarvanje kože, oči in drugih tkiv
English: If further dose modification is required, then reduce the number of doses to 2 per cycle for subsequent cycles.
Slovenian: Če je potrebno nadaljnje prilagajanje odmerka, zmanjšajte število odmerkov pri naslednjih ciklih na 2 na cikel.
English: 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.
Slovenian: 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.
English: Do not mix BESPONSA or administer as an infusion with other medicinal products.
Slovenian: Zdravila BESPONSA ne smemo mešati ali dajati kot infuzijo z drugimi zdravili.
English: In the clinical study, the sensitivity of some local tests was lower than the central laboratory test.
Slovenian: V kliničnem preskušanju je bila občutljivost nekaterih lokalnih preskusov manjša kot občutljivost preskusa centralnega laboratorija, zato je treba uporabljati samo validirane preskuse z dokazano veliko občutljivostjo.
English: During treatment, especially in the first few days after starting treatment, you may have raised liver enzymes.
Slovenian: Med zdravljenjem in zlasti v prvih nekaj dneh po začetku zdravljenja imate lahko zvečane vrednosti jetrnih encimov.
English: If particles or discolouration are observed, do not use.
Slovenian: Če opazite delce ali obarvanost, je ne uporabite.
English: Withdraw this amount from the vial(s) using a syringe.
Slovenian: Z brizgo izvlecite to količino iz vial(e).
English: During treatment, especially in the first few days after starting treatment, your white blood cell count may be severely lowered (neutropenia), which may be accompanied by fever (febrile neutropenia).
Slovenian: Med zdravljenjem in zlasti v prvih nekaj dneh po začetku zdravljenja se vam lahko število belih krvnih celic močno zmanjša (nevtropenija), kar lahko spremlja vročina (febrilna nevtropenija).
English: These may include corticosteroids (e.g., dexamethasone), antipyretics (medicines to reduce fever), and antihistamines (medicines to reduce allergic reactions).
Slovenian: Ta zdravila lahko vključujejo kortikosteroide (npr. deksametazon), antipiretike (zdravila za zniževanje vročine) in antihistaminike (zdravila za zmanjševanje alergijskih reakcij).
English: In animals, the primary target organs included the liver, bone marrow and lymphoid organs with associated haematological changes, kidney, and nervous system.
Slovenian: Pri živalih so primarni tarčni organi vključevali jetra, kostni mozeg in limfatične organe s povezanimi hematološkimi spremembami, ledvice in živčni sistem.
English: For patients who develop abnormal liver tests, liver tests and clinical signs and symptoms of hepatotoxicity should be monitored more frequently.
Slovenian: Pri bolnikih, pri katerih pride do nenormalnih vrednosti jetrnih testov, je treba jetrne teste in klinične znake ter simptome hepatotoksičnosti spremljati pogosteje.
English: BESPONSA must not be used during pregnancy unless the potential benefit to the mother outweighs the potential risks to the foetus.
Slovenian: Zdravila BESPONSA se ne sme uporabljati med nosečnostjo, razen če morebitna korist za mater odtehta morebitna tveganja za plod.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with BESPONSA in 1 or more subsets of the paediatric population for the treatment of relapsed or refractory ALL (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom BESPONSA za 1 ali več podskupin pediatrične populacije za zdravljenje recidivne ali refraktarne ALL (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: This belongs to a group of medicines that target cancer cells.
Slovenian: Sodi v skupino zdravil, ki so usmerjena proti rakavim celicam.
English: The table below shows the recommended dosing regimens.
Slovenian: Spodnja preglednica prikazuje priporočene režime odmerjanja.
English: This risk was most marked in patients who underwent subsequent HSCT.
Slovenian: To tveganje je bilo najizrazitejše pri bolnikih, pri katerih so v nadaljevanju opravili PKMC.
English: The co-primary endpoints were CR/CRi, assessed by a blinded independent endpoint adjudication committee (EAC), and overall survival (OS).
Slovenian: Sočasna primarna opazovana dogodka sta bila CR/CRi, ki ju je ocenjeval neodvisni slepljeni Odbor za presojo opazovanih dogodkov (EAC - Endpoint Adjudication Committee), in celokupno preživetje (OS - Overall Survival).
English: For patients who proceed to HSCT, liver tests should be monitored closely during the first month post-HSCT, then less frequently thereafter, according to standard medical practice.
Slovenian: Pri bolnikih, pri katerih bodo opravili PKMC, je treba v prvem mesecu po PKMC skrbno spremljati jetrne teste, nato pa manj pogosto v skladu z običajno medicinsko prakso.
English: Table 1 shows the recommended dosing regimens.
Slovenian: Preglednica 1 prikazuje priporočene režime odmerjanja.
English: BESPONSA improved OS versus Investigator's choice of chemotherapy for all stratification factors including duration of first remission ≥12 months, Salvage 1 status, and age at randomisation <55 years.
Slovenian: Zdravilo BESPONSA je v primerjavi s kemoterapijo po izbiri raziskovalca izboljšalo OS pri vseh stratifikacijskih dejavnikih, vključno s trajanjem prve remisije  12 mesecev, rešilnim statusom 1 in starostjo ob randomizaciji < 55 let.
English: Interrupt treatment until recovery to Grade 1 or pre-treatment grade levels prior to each dose.
Slovenian: Zdravljenje prekinite do izboljšanja na stopnjo 1 ali stopnjo pred zdravljenjem pred vsakim odmerkom.
English: If an infusion related reaction occurs, the infusion should be interrupted and appropriate medical management should be instituted.
Slovenian: Če se pojavi z infuzijo povezana reakcija, je treba infundiranje prekiniti in zagotoviti ustrezno medicinsko obravnavo.
English: The effects of BESPONSA in pregnant women are not known, but based on its mechanism of action BESPONSA may harm your unborn baby.
Slovenian: Učinki zdravila BESPONSA na nosečnice niso znani, vendar lahko zdravilo BESPONSA glede na svoj mehanizem delovanja škoduje vašemu nerojenemu otroku.
English: The median time to onset of hyperbilirubinaemia and increased transaminases was 73 days and 29 days, respectively.
Slovenian: Mediani čas do pojava hiperbilirubinemije in zvečanja vrednosti transaminaz je bil 73 dni oziroma 29 dni.
English: Signs may include elevations in total bilirubin, hepatomegaly (which may be painful), rapid weight gain, and ascites.
Slovenian: Znaki lahko vključujejo zvečanje celokupnega bilirubina, hepatomegalijo (ki je lahko boleča), hitro zvečanje telesne mase in ascites.
English: Among all 326 randomised patients (ITT population), 215 (66%) patients had received 1 prior treatment regimen and 108 (33%) patients had received 2 prior treatment regimens for ALL.
Slovenian: Od vseh 326 randomiziranih bolnikov (populacija ITT) je 215 (66 %) bolnikov prejelo 1 predhodni režim zdravljenja, 108 (33 %) bolnikov pa je prejelo 2 predhodna režima zdravljenja za ALL.
English: Contact your doctor immediately if you or your partner becomes pregnant during the period of treatment with this medicine.
Slovenian: Nemudoma obvestite zdravnika, če med zdravljenjem s tem zdravilom vi ali vaša partnerka zanosite.
English: In patients with an inadequate bone marrow aspirate sample, a peripheral blood sample was tested.
Slovenian: Pri bolnikih z nezadostnim vzorcem aspirata kostnega mozga so testirali vzorec periferne krvi.
English: Patients should be monitored closely during and for at least 1 hour after the end of infusion for the potential onset of infusion related reactions, including symptoms such as hypotension, hot flush, or breathing problems.
Slovenian: Bolnike je treba med infundiranjem in najmanj 1 uro po koncu infundiranja skrbno spremljati glede morebitnega pojava z infuzijo povezanih reakcij, vključno s simptomi, kot so hipotenzija, vročinski oblivi ali težave z dihanjem.