FrancophonIA/ELRC3.0 huggingface dataset:
English: Total bilirubin > 1.5 × ULN and AST/ALT > 2.5 × ULN
Slovenian: celokupni bilirubin > 1,5 × ZMN in AST/ALT > 2,5 × ZMN
English: • Reduced number of red blood cells which may result in fatigue and shortness of breath
Slovenian: • zmanjšano število rdečih krvnih celic, kar lahko povzroči utrujenost in kratko sapo
English: Of 93 screened patients, 72 patients were assigned to study drug and treated with BESPONSA.
Slovenian: Od 93 pregledanih bolnikov so jih 72 dodelili na in zdravili s preučevanim zdravilom BESPONSA.
English: progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi.
Slovenian: napredovala bolezen (vključno z objektivnim napredovanjem, ponovitvijo bolezni od CR/CRi, prekinitvijo zdravljenja zaradi splošnega poslabšanja zdravstvenega stanja) in začetek novega indukcijskega zdravljenja ali PKMC po zdravljenju brez dosežene CR/CRi.
English: Other observed changes included male and female reproductive organ effects (see below) and preneoplastic and neoplastic liver lesions
Slovenian: Druge opažene spremembe so vključevale učinke na moške in ženske reprodukcijske organe (glejte spodaj) in preneoplastične in neoplastične lezije v jetrih (glejte spodaj).
English: Men and women should seek advice regarding fertility preservation before treatment.
Slovenian: Moški in ženske se morajo pred zdravljenjem posvetovati glede ohranjanja plodnosti.
English: BESPONSA is intended for the treatment of acute lymphoblastic leukaemia for adult patients who have previously tried other treatments and for whom those treatments have failed.
Slovenian: Zdravilo BESPONSA uporabljamo za zdravljenje akutne limfoblastne levkemije pri odraslih bolnikih, ki so predhodno že preskusili druga zdravljenja in so bila ta neuspešna.
English: Dosing regimen for Cycle 1 and subsequent cycles depending on response to treatment
Slovenian: Režim odmerjanja za 1. cikel in naslednje cikle glede na odziv na zdravljenje
English: Baseline characteristics were similar in the initial 218 patients randomised.
Slovenian: Osnovne značilnosti so bile podobne pri vseh začetnih 218 randomiziranih bolnikih.
English: The safety and efficacy of BESPONSA were evaluated in a single-arm, open-label, multicentre Phase 1/2 study (Study 2).
Slovenian: Varnost in učinkovitost zdravila BESPONSA so ocenili v odprti, multicentrični študiji 1./2.
English: Although there was a higher frequency of early deaths post-HSCT (at Day 100) in the BESPONSA arm, there was evidence of a late survival benefit for BESPONSA.
Slovenian: Čeprav je bila pogostnost zgodnjih smrti po PKMC (100. dan) večja v skupini z zdravilom BESPONSA, so za zdravilo BESPONSA obstajali dokazi o poznejšem izboljšanju preživetja.
English: What you need to know before you are given BESPONSA
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo BESPONSA
English: No formal clinical drug interaction studies have been performed (see section 5.2).
Slovenian: Formalnih kliničnih preskušanj medsebojnega delovanja niso izvedli (glejte poglavje 5.2).
English: • If the medicine works well and you are going to receive a stem cell transplant (see section 2),
Slovenian: • Če zdravilo deluje dobro in bodo pri vas opravili presaditev matičnih celic (glejte poglavje 2),
English: Note: patients may have had > 1 type of haemorrhage.
Slovenian: Opomba: bolniki so lahko imeli > 1 vrsto krvavitve.
English: All patients were required to have ≥ 5% bone marrow blasts and to have received 1 or 2 prior induction chemotherapy regimens for ALL.
Slovenian: Zahtevali so, da morajo vsi bolniki imeti ≥ 5 % blastov v kostnem mozgu in so za ALL prejeli 1 ali 2 predhodna režima indukcijske kemoterapije.
English: Interrupt the next dose (maintain a minimum of 6 days between doses).
Slovenian: Prekinite naslednji odmerek (med odmerki mora miniti vsaj 6 dni).
English: • Reduced number of lymphocytes (a type of white blood cells) which may result in a tendency to develop infections
Slovenian: • zmanjšano število limfocitov (vrsta belih krvnih celic), kar lahko povzroči nagnjenost k razvoju okužb
English: • 1 glass vial containing a white to off-white lyophilised cake or powder.
Slovenian: • 1 stekleno vialo, ki vsebuje belo do belkasto liofilizirano pogačo ali prašek.
English: Before your treatment with BESPONSA, you will be given other medicines (pre-medications) to help reduce infusion reactions and other possible side effects.
Slovenian: Pred zdravljenjem z zdravilom BESPONSA boste prejeli druga zdravila (premedikacija), ki bodo pomagala zmanjšati z infuzijo povezane reakcije in druge morebitne neželene učinke.
English: Tell your doctor, pharmacist or nurse immediately if you became pregnant during the period of treatment with BESPONSA and for up to 8 months after finishing treatment.
Slovenian: Nemudoma obvestite zdravnika, farmacevta ali medicinsko sestro, če med zdravljenjem z zdravilom BESPONSA in v času do 8 mesecev po koncu zdravljenja zanosite.
English: No adjustment to the starting dose is required based on age (see section 5.2).
Slovenian: Prilagajanje začetnega odmerka glede na starost ni potrebno (glejte poglavje 5.2).
English: BESPONSA (N=109)
Slovenian: Zdravilo BESPONSA (n = 109)
English: Dosing regimen for Cycle 1 All patients: Dose (mg/m2) Cycle length
Slovenian: Režim odmerjanja za 1. cikel Vsi bolniki: odmerek (mg/m dolžina cikla
English: In humans, the total volume of distribution of inotuzumab ozogamicin was approximately 12 L.
Slovenian: Celotni volumen porazdelitve inotuzumab ozogamicina je pri ljudeh znašal približno 12 l.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT OTHER
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
English: • The other ingredients are sucrose, polysorbate 80, sodium chloride, and tromethamine.
Slovenian: • Druge sestavine zdravila so saharoza, polisorbat 80, natrijev klorid in trometamol.
English: • High levels of liver enzymes (which can be indicators of liver injury) in the blood
Slovenian: • zvečane ravni jetrnih encimov (ki so lahko kazalniki poškodbe jeter) v krvi
English: In vitro, the binding of the N-acetyl-gamma-calicheamicin dimethylhydrazide to human plasma proteins is approximately 97%.
Slovenian: In vitro delež vezave N-acetil-gama-kaliheamicin dimetilhidrazida na človeške beljakovine v plazmi znaša približno 97 %.
English: • Reduced number of white blood cells which may result in general weakness and a tendency to develop infections
Slovenian: • zmanjšano število belih krvnih celic, kar lahko povzroči splošno oslabelost in nagnjenost k razvoju okužb
English: Toxicity and dose modification(s)
Slovenian: Toksičnost in prilagoditev(-e) odmerka
English: The median (upper bound of the 95% CI) for the change in QTcF at a supratherapeutic Cmax concentration was 3.87 msec (7.54 msec).
Slovenian: Mediana (zgornja meja 95 % IZ) za spremembo intervala QTcF pri supraterapevtski koncentraciji Cmax je bila 3,87 ms (7,54 ms).
English: Any patients who do not achieve a CR/CRi within 3 cycles should discontinue treatment.
Slovenian: Vsi bolniki, ki v 3 ciklih ne dosežejo CR/CRi, morajo zdravljenje prekiniti.
English: CR/CRi and MRD negativity findings in the initial 218 randomised patients were consistent with those seen in all 326 randomised patients.
Slovenian: CR/CRi in negativni izvidi za MRD pri prvotnih 218 randomiziranih bolnikih so bili skladni s tistimi, ki so jih opazili pri vseh 326 randomiziranih bolnikih.
English: Febrile neutropenia, which may be life-threatening, was reported in 43 (26%) patients.
Slovenian: O febrilni nevtropeniji, ki je lahko življenjsko ogrožajoča, so poročali pri 43 (26 %) bolnikih.
English: Abbreviation: ANC=absolute neutrophil count.
Slovenian: Okrajšava: ANC = absolutno število nevtrofilcev.
English: Fatal infections, including pneumonia, neutropenic sepsis, sepsis, septic shock, and pseudomonal sepsis, were reported in 8 (5%) patients.
Slovenian: O smrtnih okužbah, vključno s pljučnico, nevtropenično sepso, sepso, septičnim šokom in sepso, ki jo povzroča bakterija Pseudomonas aeruginosa, so poročali pri 8 (5 %) bolnikih.
English: Inotuzumab ozogamicin pharmacokinetics were well characterised by a 2-compartment model with linear and time-dependent clearance components.
Slovenian: Za farmakokinetiko inotuzumab ozogamicina je bil zelo značilen dvoprostorni model z linearnimi in časovno odvisnimi komponentami očistka.
English: BESPONSA doses within a treatment cycle (i.e. Days 8 and/or 15) do not need to be interrupted due to neutropenia or thrombocytopenia, but dosing interruptions within a cycle are recommended for non-haematological toxicities.
Slovenian: Znotraj cikla zdravljenja (tj. 8. in/ali 15. dan) odmerjanja zdravila BESPONSA ni treba prekiniti zaradi nevtropenije ali trombocitopenije, vendar pa so prekinitve odmerjanja znotraj cikla priporočljive pri nehematološki toksičnosti.
English: The secondary endpoints included MRD negativity, duration of remission (DoR), HSCT rate, and progression-free survival (PFS).
Slovenian: Sekundarni opazovani dogodki so vključevali negativen izvid za MRD, trajanje remisije (DoR - Duration of Remission), stopnjo PKMC in preživetje brez napredovanja bolezni (PFS - Progression-Free Survival).
English: Vaccination with live viral vaccines is not recommended for at least 2 weeks prior to the start of BESPONSA treatment, during treatment, and until recovery of B lymphocytes following the last treatment cycle.
Slovenian: Cepljenje z živimi virusnimi cepivi ni priporočljivo najmanj 2 tedna pred zdravljenjem z zdravilom BESPONSA, med zdravljenjem z zdravilom in po zadnjem ciklu zdravljenja, dokler ne pride do porasta limfocitov B.
English: BESPONSA is used to treat adults with acute lymphoblastic leukaemia.
Slovenian: Zdravilo BESPONSA se uporablja za zdravljenje odraslih z akutno limfoblastno levkemijo.
English: HIDAC, FLAG, or MXN/Ara-C (N=109)
Slovenian: HiDAC, FLAG ali MXN/Ara-C (n = 109)
English: Treatment with BESPONSA may prolong QT interval (a change in electrical activity of the heart that can cause serious irregular heart rhythms).
Slovenian: Zdravljenje z zdravilom BESPONSA lahko podaljša interval QT (sprememba električne aktivnosti srca, kar lahko povzroči resno neredno bitje srca).
English: Table 2 and Table 3 show the dose modification guidelines for haematological and non-haematological toxicities, respectively.
Slovenian: Preglednica 2 oziroma 3 prikazuje smernice za prilagajanje odmerkov za hematološko oziroma nehematološko toksičnost.
English: For patient-reported outcomes, most functioning and symptom scores were in favour of BESPONSA compared to Investigator's choice of chemotherapy.
Slovenian: Pri izidih, o katerih so poročali bolniki, je bila večina rezultatov funkcionalnosti in simptomov v korist zdravilu BESPONSA v primerjavi s kemoterapijo po izbiri raziskovalca.
English: Table 4 shows the dose modification guidelines depending on the duration of dosing interruptions due to toxicity.
Slovenian: Preglednica 4 prikazuje smernice za prilagajanje odmerkov glede na trajanje prekinitev odmerjanja zaradi toksičnosti.
English: Before your treatment with BESPONSA, you may be given medicines and be hydrated to prevent tumour lysis syndrome from occurring.
Slovenian: Pred zdravljenjem z zdravilom BESPONSA boste morda prejeli zdravila in boste hidrirani za preprečevanje pojava sindroma tumorske lize.
English: Other medicines and BESPONSA
Slovenian: Druga zdravila in zdravilo BESPONSA
English: In humans, serum N-acetyl-gamma-calicheamicin dimethylhydrazide levels were typically below the limit of quantitation (50 pg/mL), but sporadic measurable levels of unconjugated calicheamicin up to 276 pg/mL occurred in some patients.
Slovenian: Pri ljudeh so bile serumske vrednosti N-acetil-gama-kaliheamicin dimetilhidrazida običajno pod mejo kvantifikacije (50 pg/ml), pri nekaterih bolnikih pa so se občasno pojavljale izmerljive ravni nekonjugiranega kaliheamicina do 276 pg/ml.
English: In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil morata biti v bolnikovi kartoteki jasno dokumentirana (ali navedena) lastniško ime in številka serije prejetega zdravila.
English: Adverse reactions included treatment-emergent, all-causality events that commenced on, or after Cycle 1 Day 1 within 42 days after the last dose of BESPONSA, but prior to the start of a new anticancer treatment (including HSCT).
Slovenian: Neželeni učinki so vključevali dogodke iz vseh vzrokov, ki so se pojavili zaradi zdravljenja na 1. dan 1. cikla ali po njem v 42 dneh po zadnjem odmerku zdravila BESPONSA, vendar pred začetkom novega zdravljenja proti rakavemu obolenju (vključno s PKMC).
English: • Your doctor will decide on the correct dose.
Slovenian: • Pravi odmerek bo določil zdravnik.
English: Slight foetal growth retardation in rats also occurred at approximately 0.4 times the human clinical exposure based on AUC (see section 4.6).
Slovenian: Rahla upočasnitev rasti ploda pri podganah se je pojavila tudi pri približno 0,4-kratniku klinične izpostavljenosti pri ljudeh na podlagi vrednosti AUC (glejte poglavje 4.6).
English: The QT interval should be monitored in case of combinations of such medicinal products (see sections 4.4, 4.8, and 5.2).
Slovenian: V primeru kombinacij teh zdravil je treba spremljati interval QT (glejte poglavja 4.4, 4.8 in 5.2).
English: Among the 79 patients who proceeded to a subsequent HSCT (8 of whom received additional salvage therapy after treatment with BESPONSA before proceeding to HSCT), VOD/SOS was reported in 18 (23%) patients.
Slovenian: Izmed 79 bolnikov, pri katerih so opravili PKMC (8 od njih je po zdravljenju z zdravilom BESPONSA prejelo dodatno rešilno zdravljenje, preden so pri njih opravili PKMC), so o VOD/SOS poročali pri 18 (23 %) bolnikih.
English: 2-sided p-value = 0.0022
Slovenian: 2-stranska vrednost p = 0,0022
English: Among all 326 randomised patients, the survival probability at 24 months was 22.8% in the BESPONSA arm and 10% in the Investigator's choice of chemotherapy arm.
Slovenian: Med vsemi 326 randomiziranimi bolniki je bila verjetnost preživetja po 24 mesecih 22,8 % v skupini z zdravilom BESPONSA in 10 % v skupini s kemoterapijo po izbiri raziskovalca.
English: Infusion related reactions generally occurred in Cycle 1 and shortly after the end of the inotuzumab ozogamicin infusion and resolved spontaneously or with medical management.
Slovenian: Z infuzijo povezane reakcije so se običajno pojavile v 1. ciklu in kmalu po koncu infundiranja inotuzumab ozogamicina ter so izzvenele spontano ali z medicinsko obravnavo.
English: HIDAC, FLAG, or MXN/Ara-C (N=162)
Slovenian: HiDAC, FLAG ali MXN/Ara-C (n = 162)
English: The safety of immunisation with live viral vaccines during or following BESPONSA therapy has not been studied.
Slovenian: Varnosti imunizacije z živimi virusnimi cepivi med zdravljenjem ali po zdravljenju z zdravilom BESPONSA niso preučevali.
English: Management of severe infection, bleeding/haemorrhage and other effects of myelosuppression, including severe neutropenia or thrombocytopenia, may require a dosing interruption, dose reduction, or discontinuation of treatment (see section 4.2).
Slovenian: Obvladovanje hude okužbe, krvavitve in drugih učinkov mielosupresije, vključno s hudo nevtropenijo ali trombocitopenijo, lahko zahteva prekinitev odmerjanja, zmanjšanje odmerka ali prekinitev zdravljenja (glejte poglavje 4.2).
English: Based on a population pharmacokinetic analysis, age, race, and gender did not significantly affect inotuzumab ozogamicin disposition.
Slovenian: Glede na populacijsko farmakokinetično analizo starost, rasa in spol niso pomembno vplivali na odstranjevanje inotuzumab ozogamicina.
English: Inotuzumab is a humanised immunoglobulin class G subtype 4 (IgG4) antibody that specifically recognises human CD22.
Slovenian: Inotuzumab je humanizirano protitelo, imunoglobulin razreda G podtipa 4 (IgG4), ki specifično prepoznava humani CD22.
English: • Add the reconstituted solution to an infusion container with sodium chloride 9 mg/mL (0.9%) solution for injection, to a total nominal volume of 50 mL.
Slovenian: • Rekonstituirano raztopino dodajte v infuzijski vsebnik z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje do skupnega nominalnega volumna 50 ml.
English: BESPONSA should be administered with caution in patients who have a history of, or predisposition to QT interval prolongation, who are taking medicinal products that are known to prolong QT interval (see section 4.5) and in patients with electrolyte disturbances.
Slovenian: Zdravilo BESPONSA je treba uporabljati previdno pri bolnikih, ki imajo podaljšanje intervala QT v anamnezi ali so nagnjeni k podaljšanju intervala QT, pri bolnikih, ki jemljejo zdravila, za katera je znano, da podaljšajo interval QT (glejte poglavje 4.5), ter pri bolnikih z motnjami elektrolitov.
English: Inotuzumab ozogamicin (which has a density of 1.02 g/mL at 20 °C/68 °F) is light sensitive and should be protected from ultraviolet light during reconstitution, dilution, and administration.
Slovenian: Inotuzumab ozogamicin (ki ima gostoto 1,02 g/ml pri 20 °C/68 °F) je občutljiv na svetlobo in ga je treba med rekonstitucijo, redčenjem in uporabo zaščititi pred ultravijolično svetlobo.
English: In 234 patients with relapsed or refractory ALL, the clearance of inotuzumab ozogamicin at steady state was 0.0333 L/h, and the terminal elimination half-life (t½) at the end of Cycle 4 was approximately 12.3 days.
Slovenian: Pri 234 bolnikih z recidivno ali refraktarno ALL je bil očistek inotuzumab ozogamicina v stanju dinamičnega ravnovesja 0,0333 l/h, končni razpolovni čas izločanja (t½) ob koncu 4. cikla pa je znašal približno 12,3 dneva.
English: Based on a population pharmacokinetic analysis in 765 patients, body surface area was found to significantly affect inotuzumab ozogamicin disposition.
Slovenian: S populacijsko farmakokinetično analizo pri 765 bolnikih so ugotovili, da telesna površina pomembno vpliva na odstranjevanje inotuzumab ozogamicina.
English: In the Phase 2 portion of the study, 8/35 (22.9%) patients had a follow-up HSCT.
Slovenian: V 2. fazi študije so 8/35 (22,9 %) bolnikom v nadaljevanju opravili PKMC.
English: By central and local laboratory tests, 231/253 (91.3%) patients and 130/253 (51.4%) patients, respectively, had ≥ 70% CD22-positive leukaemic blasts at baseline.
Slovenian: Rezultati preskusov centralnega oziroma lokalnega laboratorija kažejo, da je 231/253 (91,3 %) bolnikov oziroma 130/253 (51,4 %) bolnikov imelo ≥ 70% CD22-pozitivnih levkemičnih blastov ob izhodišču.
English: • QT interval prolongation (see section 2); signs and symptoms include a change in electrical activity of the heart that can cause serious irregular heart rhythms.
Slovenian: • podaljšanje intervala QT (glejte poglavje 2); znaki in simptomi vključujejo spremembo električne aktivnosti srca, kar lahko povzroči resno neredno bitje srca.
English: Population pharmacokinetic/pharmacodynamic evaluation suggested a correlation between increasing inotuzumab ozogamicin serum concentrations and prolongation of QTc intervals in ALL and non-Hodgkin's lymphoma (NHL) patients.
Slovenian: Populacijsko farmakokinetično/farmakodinamično vrednotenje je pokazalo povezavo med zvečanjem koncentracij inotuzumab ozogamicina v serumu in podaljšanjem intervalov QTc pri bolnikih z ALL in ne-Hodgkinovim limfomom (NHL).
English: Depending on the severity of the infusion related reaction, consider discontinuation of the infusion or administration of steroids and antihistamines.
Slovenian: Glede na resnost z infuzijo povezane reakcije razmislite o prekinitvi infundiranja ali uporabi steroidov in antihistaminikov.
English: Hepatotoxicity, including venoocclusive liver disease/sinusoidal obstruction syndrome (VOD/SOS)
Slovenian: Hepatotoksičnost, vključno z venookluzivno boleznijo jeter/sindromom obstrukcije sinusoidov (VOD/SOS)
English: BESPONSA (N=35)
Slovenian: Zdravilo BESPONSA (n = 35)
English: ECG and electrolytes should be obtained prior to the start of treatment and periodically monitored during treatment (see sections 4.8 and 5.2).
Slovenian: Pred začetkom zdravljenja je treba pridobiti EKG in vrednosti elektrolitov in jih med zdravljenjem redno spremljati (glejte poglavji 4.8 in 5.2).
English: Tumour lysis syndrome (2%) Hyperuricaemia (4%)
Slovenian: sindrom tumorske lize (2 %) hiperurikemija (4 %)
English: Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal; VOD/SOS=venoocclusive disease/sinusoidal obstruction syndrome.
Slovenian: Okrajšave: ALT = alanin-aminotransferaza; AST = aspartat-aminotransferaza; ZMN = zgornja meja normale; VOD/SOS = venookluzivna bolezen jeter/sindrom obstrukcije sinusoidov.
English: Overdoses may result in adverse reactions that are consistent with the reactions observed at the recommended therapeutic dose (see section 4.8).
Slovenian: Preveliko odmerjanje lahko povzroči neželene učinke, ki so skladni z učinki, opaženimi pri priporočenem terapevtskem odmerku (glejte poglavje 4.8).
English: In clinical studies of BESPONSA in patients with relapsed or refractory ALL, 7/236 (3%) patients tested positive for anti-inotuzumab ozogamicin antibodies.
Slovenian: V kliničnih preskušanjih z zdravilom BESPONSA pri bolnikih z recidivno ali refraktarno ALL je bilo 7/236 (3 %) bolnikov pozitivnih na protitelesa proti inotuzumab ozogamicinu.
English: Instructions for reconstitution, dilution, and administration
Slovenian: Navodila za rekonstitucijo, redčenje in uporabo
English: Permanently discontinue treatment (see section 4.4).
Slovenian: Zdravljenje trajno prekinite (glejte poglavje 4.4).
English: BESPONSA must be reconstituted and diluted before administration.
Slovenian: Zdravilo BESPONSA je treba pred uporabo rekonstituirati in razredčiti.
English: Activation of N-acetyl-gamma-calicheamicin dimethylhydrazide induces double-stranded DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.
Slovenian: Aktivacija N-acetil-gama-kaliheamicin dimetilhidrazida inducira pretrganja dvojno vijačne DNK, kar posledično inducira zaustavitev celičnega cikla in apoptotično celično smrt.
English: - Protect from light.
Slovenian: - Zaščitite pred svetlobo.
English: Grade 3/4 TLS was reported in 3 (2%) patients.
Slovenian: O TLS stopnje 3/4 so poročali pri 3 (2 %) bolnikih.
English: if you have certain side effects.
Slovenian: BESPONSA, če imate določene neželene učinke.
English: Pregnant women, or patients becoming pregnant while receiving inotuzumab ozogamicin, or treated male patients as partners of pregnant women, must be apprised of the potential hazard to the fetus.
Slovenian: Če inotuzumab ozogamicin uporabljajo nosečnice, če bolnica med prejemanjem inotuzumaba ozogamicina zanosi ali če se z inotuzumab ozogamicinom zdravijo bolniki, ki so partnerji nosečnic, jih je treba seznaniti z morebitno nevarnostjo za plod.
English: MedDRA System organ class Very common
Slovenian: Organski sistem po MedDRA Zelo pogosti
English: A third cycle may be considered for those patients who do not achieve a complete remission (CR) or complete remission with incomplete haematological recovery (CRi) and minimal residual disease (MRD) negativity after 2 cycles (see section 4.4).
Slovenian: O 3. ciklu lahko razmislimo pri tistih bolnikih, ki po 2 ciklih ne dosežejo popolne remisije (CR - Complete Remission) ali popolne remisije z delnim hematološkim okrevanjem (CRi - Complete Remission with incomplete haematological recovery) in negativnega izvida za minimalno rezidualno bolezen (MRD - Minimal Residual Disease) (glejte poglavje 4.4).
English: Because of the potential for adverse reactions in breast-fed children, women must not breast-feed during treatment with BESPONSA and for at least 2 months after the final dose (see section 5.3).
Slovenian: Zaradi možnosti za neželene učinke pri dojenih otrocih ženske med zdravljenjem z zdravilom BESPONSA in vsaj 2 meseca po zadnjem odmerku ne smejo dojiti (glejte poglavje 5.3).