FrancophonIA/ELRC3.0 huggingface dataset:
English: • Difficulty breathing, including shortness of breath at rest or with activity or a cough (dyspnoea), rapid breathing, feeling like you can't breathe in enough air, wheezing, or cough, which can be signs of lung toxicity
Croatian: • Otežano disanje, uključujući nedostatak zraka u mirovanju ili pri aktivnosti ili kašalj (zaduha), ubrzano disanje, osjećaj da ne možete udahnuti dovoljnu količinu zraka, piskanje ili kašalj, što mogu biti znakovi plućne toksičnosti
English: Patients with New York Heart Association (NYHA) Class III and IV heart failure, recent myocardial infarction, and conduction abnormalities uncontrolled by medicinal products were not eligible for the clinical trials.
Croatian: New York Heart Association) klase III i IV, nedavnim infarktom miokarda i abnormalnostima provodljivosti koje se ne drže pod kontrolom lijekovima nisu bili podobni za sudjelovanje u kliničkim ispitivanjima.
English: Cardiac failure, myocardial infarction and myocardial ischaemia
Croatian: Zatajenje srca, infarkt miokarda i ishemija miokarda
English: Therefore, resumption of therapy should be discussed with experts in managing HBV.
Croatian: Stoga o nastavku terapije treba razgovarati sa stručnjacima za liječenje infekcije HBV-om.
English: Carfilzomib is primarily metabolised via peptidase and epoxide hydrolase activities, and as a result, the pharmacokinetic profile of carfilzomib is unlikely to be affected by concomitant administration of cytochrome P450 inhibitors and inducers.
Croatian: Karfilzomib se primarno metabolizira putem aktivnosti peptidaze i epoksid hidrolaze, a kao rezultat toga, nije vjerojatno da će na farmakokinetički profil karfilzomiba utjecati istodobna primjena inhibitora i induktora citokroma P450.
English: When administering in an intravenous bag, use only a 21-gauge or larger gauge needle (0.8 mm or smaller external diameter needle) to withdraw the calculated dose from the vial and dilute into a 50 or 100 mL intravenous bag containing 5% glucose solution for injection.
Croatian: Kada se primjenjuje u vrećici za infuziju, upotrijebite samo iglu veličine 21G ili više G (0,8 mm ili manjeg vanjskog promjera igle) da izvučete izračunatu dozu iz bočice i razrijedite u vrećici za infuziju od 50 ili 100 ml u kojoj se nalazi 5%-tna otopina glukoze za injekcije.
English: • Reactivation of the chicken pox virus (shingles) that can cause a skin rash and pain (herpes zoster)
Croatian: • Reaktiviracija virusa uzročnika vodenih kozica (varicella-zoster virusa), što može uzrokovati kožni osip i bol (herpes zoster)
English: This medicine contains 0.3 mmol sodium (which is 7 mg sodium) per mL of reconstituted solution.
Croatian: Ovaj lijek sadrži 0,3 mmol natrija (što odgovara 7 mg natrija) po ml rekonstituirane otopine.
English: At the higher dose of 56 mg/m2, there was not only a greater inhibition of CT-L subunits (≥ 90%) compared to those at 15 to 20 mg/m2, but also a greater inhibition of other proteasome subunits (LMP7, MECL1, and LMP2).
Croatian: Pri višoj dozi od 56 mg/m2, ne samo da je u usporedbi s dozama od 15 do 20 mg/m2 postojala veća inhibicija CT-L podjedinica (≥ 90%), već je postojala i veća inhibicija drugih proteasomskih podjedinica (LMP7, MECL1, i LMP2).
English: PFS months median (95% CI)a
Croatian: PFS u mjesecima, medijan (95% CI)a
English: The safety and efficacy of Kyprolis were evaluated in a phase 3, randomised, open-label, multicentre study of Kyprolis plus dexamethasone (Kd) versus bortezomib plus dexamethasone (Vd).
Croatian: Sigurnost i djelotvornost lijeka Kyprolis procijenjene su u randomiziranom, otvorenom, multicentričnom ispitivanju faze 3 kombinacije lijeka Kyprolis i deksametazona (Kd) naspram kombinacije bortezomiba i deksametazona (Vd).
English: • Fluid build-up in the lining of the heart (pericardial effusion), symptoms include chest pain or pressure and shortness of breath
Croatian: • Nakupljanje tekućine u ovojnici srca (perikardni izljev), simptomi uključuju bol ili pritisak u prsnom košu i nedostatak zraka
English: The 20/27 mg/m2 dose is administered over 10 minutes.
Croatian: Doza od 20/27 mg/m2 primjenjuje se tijekom 10 minuta.
English: Ensure that patients are well hydrated before administration of Kyprolis in cycle 1, and in subsequent cycles as needed (see section 4.2).
Croatian: Osigurajte dovoljnu hidraciju bolesnika prije primjene lijeka Kyprolis u 1. ciklusu, te u sljedećim ciklusima prema potrebi (vidjeti dio 4.2).
English: Patients who had the following were excluded from the trial: creatinine clearance rates < 50 mL/min, NYHA Class III to IV congestive heart failure, or myocardial infarction within the last 4 months, disease progression during the treatment with a bortezomib-containing regimen, or progression during the first 3 months of initiating treatment with lenalidomide and dexamethasone, or progression at any time during treatment with lenalidomide and dexamethasone if this was the subject's most recent line of therapy.
Croatian: Iz ispitivanja su bili isključeni bolesnici sa sljedećim: brzina klirensa kreatinina < 50 ml/min, kongestivno zatajenje srca NYHA razreda III do IV ili infarkt miokarda unutar posljednja 4 mjeseca, progresija bolesti tijekom liječenja režimom koji sadrži bortezomib, ili progresija bolesti tijekom prva tri mjeseca od inicijacije liječenja lenalidomidom i deksametazonom, ili progresija bolesti u bilo kojem trenutku liječenja lenalidomidom ili deksametazonom ako je to bila posljednja linija liječenja.
English: The median OS improved by 7.9 months in patients in the KRd arm compared with those in the Rd arm (see Table 6 and Figure 2).
Croatian: Kod bolesnika unutar KRd skupine, medijan ukupnog preživljenja (OS) poboljšan je za 7,9 mjeseci u usporedbi s onima u skupini Rd (vidjeti Tablicu 6. i Sliku 2).
English: As Kyprolis is administered in combination with other medicinal products, refer to their summaries of product characteristics for additional contraindications.
Croatian: S obzirom da se Kyprolis primjenjuje u kombinaciji s drugim lijekovima, provjerite njihove sažetke opisa svojstava lijeka za informacije o dodatnim kontraindikacijama.
English: Note: Kyprolis infusion times remain unchanged during dose reduction(s) a. If symptoms do not resolve, discontinue Kyprolis treatment
Croatian: Napomena: Trajanje infuzije lijeka Kyprolis ostaje nepromijenjeno tijekom smanjenja doze a.
English: Based on a number of angioedema cases reported in relation to carfilzomib monotherapy or combination therapy, 5 of which with positive dechallenge, and the plausible mechanism considering possible class effect (bortezomib has angioedema included in section 4.8 of SmPC), as well as presented cases which suggest causal role of carfilzomib, the PRAC considers that the product information (PI) should be updated to include this adverse reaction.
Croatian: Na temelju više slučajeva angioedema prijavljenih u vezi s monoterapijom ili kombiniranim liječenjem karfilzomibom, od kojih je u 5 bolesnika došlo do povlačenja nuspojava nakon prekida uzimanja lijeka (pozitivan dechallenge), i vjerojatnog mehanizma uzimajući u obzir mogući učinak skupine lijekova (angioedem je uključen u dio 4.8 sažetka opisa svojstava lijeka za lijek bortezomib), kao i iznesenih slučajeva koji ukazuju na uzročnu ulogu karfilzomiba, PRAC smatra da je potrebno ažurirati informacije o lijeku kako bi se uključila ova nuspojava.
English: Female patients of child bearing potential treated with Kyprolis (and/or their partners) must use effective contraception measures during and for one month following treatment.
Croatian: Bolesnice reproduktivne dobi liječene lijekom Kyprolis (i/ili njihovi partneri) moraju primjenjivati učinkovite mjere kontracepcije tijekom i jedan mjesec nakon liječenja.
English: The first study was conducted in 50 multiple myeloma patients with normal renal function (CrCL > 80 mL/min, n = 12), mild (CrCL 50-80 mL/min, n = 12), moderate (CrCL 30-49 mL/min, n = 10), and severe (CrCL < 30 mL/min, n = 8) renal impairment, and patients on chronic dialysis (n = 8).
Croatian: Prvo ispitivanje provedeno je na 50 bolesnika s multiplim mijelomom koji su imali normalnu funkciju bubrega (CrCL > 80 ml/min, n = 12), blago (CrCL 50 - 80 ml/min, n = 12), umjereno (CrCL 30 - 49 ml/min, n = 10) ili teško oštećenje bubrega (CrCL < 30 ml/min, n = 8), te koji su bili na kroničnoj dijalizi (n = 8).
English: Calculate the dose (mg/m2) and number of vials of Kyprolis required using the patient's BSA at baseline.
Croatian: Izračunajte dozu (mg/m2) i broj potrebnih bočica lijeka Kyprolis temeljem površine tijela bolesnika prije početka liječenja.
English: The 20/56 mg/m2 dose must be administered over 30 minutes.
Croatian: Doza od 20/56 mg/m2 mora se primijeniti tijekom 30 minuta.
English: Kyprolis in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma - study PX-171-009 (ASPIRE)
Croatian: Kyprolis u kombinaciji s lenalidomidom i deksametazonom u liječenju bolesnika s recidivirajućim multiplim mijelomom - ispitivanje PX-171-009 (ASPIRE)
English: Kyprolis is to be administered by intravenous infusion.
Croatian: Kyprolis se primjenjuje intravenskom infuzijom.
English: • Stop until resolved or returned to baseline
Croatian: • Prekinite liječenje do oporavka ili povratka na početno stanje
English: Kyprolis monotherapy in patients with relapsed and refractory multiple myeloma
Croatian: Monoterapija lijekom Kyprolis u bolesnika s recidivirajućim i refraktornim multiplim mijelomom
English: There have been cases of QT interval prolongation reported in clinical studies.
Croatian: U kliničkim su ispitivanjima prijavljeni slučajevi produljenja QT intervala.
English: Do not take Kyprolis if you are breast-feeding.
Croatian: Ne uzimajte lijek Kyprolis ako dojite.
English: In addition, carfilzomib administration resulted in inhibition of the latent membrane protein 2 (LMP2) and multicatalytic endopeptidase complex-like 1 (MECL1) subunits of the immunoproteasome ranging from 26% to 32% and 41% to 49%, respectively, at 20 mg/m2.
Croatian: Dodatno, primjena karfilzomiba u dozi od 20 mg/m2 rezultirala je inhibicijom latentnog membranskog proteina 2 (LMP2, od eng. latent membrane protein 2), odnosno inhibicijom multikatalitičnih endopeptidaza kompleksu sličnih (MECL1, od eng. multicatalytic endopeptidase complex-like 1) podjedinica imuno-proteasoma u rasponu od 26% do 32%, odnosno 41% do 49%.
English: Discard any unused portion left in the vial.
Croatian: Bacite neiskorišteni dio lijeka zaostao u bočici.
English: Renal function should be monitored at least monthly or in accordance with accepted clinical practice guidelines, particularly in patients with lower baseline creatinine clearance.
Croatian: Funkciju bubrega potrebno je pratiti najmanje na mjesečnoj razini ili u skladu s prihvaćenim smjernicama kliničke prakse, posebno u bolesnika s nižim početnim klirensom kreatinina.
English: Do not use Kyprolis after the expiry date printed on the vial and the carton.
Croatian: Kyprolis se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji.
English: There are limited efficacy and safety data on patients with baseline creatinine clearance < 30 mL/min.
Croatian: Podaci o djelotvornosti i sigurnosti u bolesnika s početnom vrijednosti klirensa kreatitina < 30 ml/min su ograničeni.
English: Kyprolis in combination with dexamethasone for the treatment of patients with relapsed multiple myeloma - study 2011-003 (ENDEAVOR)
Croatian: Kyprolis u kombinaciji s deksametazonom u liječenju bolesnika s recidivirajućim multiplim mijelomom - ispitivanje 2011-003 (ENDEAVOR)
English: • Cough which could include chest tightness or pain, nasal congestion (bronchitis)
Croatian: • Kašalj koji može uključivati stezanje ili bol u prsnom košu, začepljen nos (bronhitis)
English: Venous thromboembolic events
Croatian: Događaji venske tromboembolije
English: Male patients must use effective contraception measures during and for 3 months following treatment if their partner is pregnant or of child bearing potential not using effective contraception.
Croatian: Muški bolesnici moraju primjenjivati učinkovite mjere kontracepcije tijekom i 3 mjeseca nakon liječenja, ako je njihova partnerica trudna ili reproduktivne dobi i ne koristi učinkovitu kontracepciju.
English: • Stop dose If recovered to ≥ 0.5 x 109/L, continue at same dose level
Croatian: Ako se vrati na vrijednosti ≥ 0,5 x 109/l, nastavite s jednakom dozom
English: - The other ingredients are betadex sulfobutyl ether sodium, anhydrous citric acid (E330) and sodium hydroxide (see section 2 ‘Kyprolis contains sodium').
Croatian: - Drugi sastojci su natrijev sulfobutileter betadeks, bezvodna citratna kiselina (E330) i natrijev hidroksid (vidjeti dio 2 „Kyprolis sadrži natrij“).
English: Similar PFS results were observed in patients who had received prior treatment with bortezomib (HR 0.56, 95% CI: 0.44, 0.73) and patients who had not received prior treatment with bortezomib (HR 0.48, 95% CI: 0.36, 0.66).
Croatian: Slični rezultati PFS-a opaženi su u bolesnika koji su bili prethodno liječeni bortezomibom (HR 0,56, 95% CI: 0,44, 0,73) i bolesnika koji nisu bili prethodno liječeni bortezomibom (HR 0,48, 95% CI:
English: Serious adverse reactions that may occur during Kyprolis treatment include: cardiac failure, myocardial infarction, cardiac arrest, myocardial ischaemia, interstitial lung disease, pneumonitis, acute respiratory distress syndrome, acute respiratory failure, pulmonary hypertension, dyspnoea, hypertension including hypertensive crises, acute kidney injury, tumour lysis syndrome, infusion related reaction, gastrointestinal haemorrhage, intracranial haemorrhage, pulmonary haemorrhage, thrombocytopenia, hepatic failure, hepatitis B virus reactivation, PRES, thrombotic microangiopathy and TTP/HUS.
Croatian: Ozbiljne nuspojave koje se mogu javiti tijekom primjene lijeka Kyprolis uključuju: zatajenje srca, infarkt miokarda, srčani zastoj, ishemiju miokarda, intersticijsku bolest pluća, pneumonitis, akutni respiratorni distres sindrom, akutno respiratorno zatajenje, plućnu hipertenziju, dispneju, hipertenziju uključujući hipertenzivnu krizu, akutnu ozljedu bubrega, sindrom lize tumora, reakcije povezane s infuzijom, gastrointestinalno krvarenje, intrakranijalno krvarenje, pulmonalno krvarenje, trombocitopeniju, zatajenje jetre, reaktivaciju virusa hepatitisa B, PRES, trombotičnu mikroangiopatiju i TTP/HUS.
English: Use only a 21-gauge or larger gauge needle (0.8 mm or smaller external diameter needle) to aseptically reconstitute each vial by slowly injecting 5 mL (for 10 mg vial), 15 mL (for 30 mg vial) or 29 mL (for 60 mg vial) sterile water for injections through the stopper and directing the solution onto the INSIDE WALL OF THE VIAL to minimise foaming.
Croatian: Upotrijebite samo iglu veličine 21G ili više G (0,8 mm ili manjeg vanjskog promjera igle) da rekonstituirate svaku bočicu u aseptičkim uvjetima sporim ubrizgavanjem 5 ml (za bočicu od 10 mg), 15 ml (za bočicu od 30 mg) ili 29 ml (za bočicu od 60 mg) sterilne vode za injekcije kroz čep i usmjeravajući otopinu na UNUTRAŠNJU STIJENKU BOČICE kako biste minimizirali stvaranje pjene.
English: Following a 30 minute infusion of the 56 mg/m2 dose, the AUC (948 ng•hr/mL) was approximately 2.5-fold that observed at the 27 mg/m2 level, and Cmax (2,079 ng/mL) was lower compared to that of 27 mg/m2 over the 2 to 10 minute infusion.
Croatian: Nakon 30-minutne infuzije doze od 56 mg/m2, vrijednost AUC (948 ng•hr/ml) bila je približno 2,5 puta veća od one opažene za dozu od 27 mg/m2, dok je vrijednost Cmax (2079 ng/ml) bila niža u usporedbi s onom za dozu od 27 mg/m2 tijekom 2 do 10-minutne infuzije.
English: In a randomised, open-label multicentre study in patients receiving Kyprolis 20/56 mg/m2 infused over 30 minutes in combination with dexamethasone (Kd, n = 464) vs bortezomib plus dexamethasone (Vd, n = 465), cases of grade 2 and higher peripheral neuropathy were reported in 7% of patients with relapsed multiple myeloma in the Kd arm, compared with 35% in the Vd arm at the time of the pre-planned OS analysis.
Croatian: U randomiziranom, otvorenom, multicentričnom ispitivanju u bolesnika koji su primali lijek Kyprolis u dozi od 20/56 mg/m2 primijenjen infuzijom u trajanju od 30 minuta, u kombinaciji s deksametazonom (Kd skupina, n = 464), naspram kombinacije bortezomiba i deksametazona (Vd skupina, n = 465), slučajevi periferne neuropatije 2. i višeg stupnja prijavljeni su u 7% bolesnika s recidivirajućim multiplim mijelomom u Kd skupini u usporedbi s 35% bolesnika u Vd skupini u vrijeme prethodno planirane OS analize.
English: Patients who had the following were excluded from the trial: creatinine clearance rates < 15 mL/min, NYHA Class III to IV congestive heart failure, myocardial infarction within the last 4 months or those with left ventricular ejection fraction (LVEF) < 40%.
Croatian: Iz ispitivanja su bili isključeni bolesnici sa sljedećim: brzina klirensa kreatinina < 15 ml/min, kongestivno zatajenje srca NYHA razreda III do IV, infarkt miokarda unutar posljednja 4 mjeseca ili oni s istisnom frakcijom lijevog ventrikula < 40%.
English: Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received Kyprolis monotherapy.
Croatian: Akutno zatajenje bubrega češće je prijavljivano u bolesnika s uznapredovalim recidivirajućim i refraktornim multiplim mijelomom koji su primali monoterapiju lijekom Kyprolis.
English: Thromboprophylaxis should be considered based on an individual benefit/risk assessment.
Croatian: Tromboprofilaksu je potrebno razmotriti na temelju procjene koristi i rizika za pojedinog bolesnika.
English: - The active substance is carfilzomib.
Croatian: - Djelatna tvar je karilfzomib.
English: • Consider restarting the next scheduled treatment at 1 dose level reductiona a. See table 4 for dose level reductions
Croatian: • Razmotrite sljedeće planirano liječenje započeti dozom smanjenom za 1 razinua a.
English: Antiviral prophylaxis should be considered in patients being treated with Kyprolis to decrease the risk of herpes zoster reactivation (see section 4.8).
Croatian: U bolesnika koji se liječe lijekom Kyprolis treba razmotriti antivirusno profilaktičko liječenje kako bi se smanjio rizik od reaktivacije virusa herpes zoster (vidjeti dio 4.8).
English: Patients with a high tumour burden should be considered to be at greater risk for TLS.
Croatian: Potrebno je uzeti u obzir da su bolesnici s velikim tumorskim opterećenjem pod većim rizikom za nastanak TLS-a.
English: However, in phase 3 clinical studies, the incidence of adverse events of acute renal failure was higher in patients with lower baseline creatinine clearance than that among patients with higher baseline creatinine clearance.
Croatian: Međutim, u kliničkim ispitivanjima faze 3, incidencija štetnih događaja akutnog zatajenja bubrega bila je veća u bolesnika s nižim početnim klirensom kreatinina nego među bolesnicima s višim početnim klirensom kreatinina.
English: Serious adverse events related to worsening renal function were more common in subjects with baseline renal dysfunction (see section 4.2).
Croatian: Ozbiljni štetni događaji povezani s pogoršanjem funkcije bubrega bili su češći u ispitanika s početnim oštećenjem funkcije bubrega (vidjeti dio 4.2).
English: Since dialysis clearance of Kyprolis concentrations has not been studied, the medicinal product should be administered after the dialysis procedure.
Croatian: Budući da nije ispitivan klirens koncentracije lijeka Kyprolis dijalizom, lijek treba primijeniti nakon dijalize.
English: Increased blood creatinine
Croatian: Povišen kreatinin u krvi
English: A pharmacokinetic study evaluated 33 patients with relapsed or progressive advanced malignancies (solid tumours; n = 31 or haematologic malignancies; n = 2) who had normal hepatic function (bilirubin ≤ upper limit of normal [ULN]; aspartate aminotransferase [AST] ≤ ULN, n = 10), mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN, n = 14), or moderate hepatic impairment (bilirubin > 1.5-3 x ULN; any AST, n = 9).
Croatian: Farmakokinetičko ispitivanje procijenilo je 33 bolesnika s recidivirajućim ili progresivnim uznapredovalim malignim oboljenjima (solidni tumori: n = 31 ili hematološke maligne bolesti: n = 2) koji su imali normalnu funkciju jetre (bilirubin ≤ gornje granice normale [GGN]; aspartat aminotransferaza [AST] ≤ GGN, n = 10), blago oštećenje jetre (bilirubin > 1 - 1,5 x GGN ili AST > GGN ali bilirubin ≤ GGN, n = 14) ili umjereno oštećenje jetre (bilirubin > 1,5 - 3 x GGN, bilo koja vrijednost AST, n = 9).
English: Cardiac arrest Myocardial ischaemia Pericarditis Pericardial effusion
Croatian: Srčani zastoj Ishemija miokarda Perikarditis Perikardni izljev
English: If tolerated, the dose should be increased on day 8 of cycle 1 to 27 mg/m2 (maximum dose 60 mg).
Croatian: Ako se doza podnosi treba ju 8. dana 1. ciklusa povećati do 27 mg/m2 (maksimalna doza 60 mg).
English: • Bleeding in the brain
Croatian: • Krvarenje u mozgu
English: Kyprolis, as a single agent, was administered intravenously over 2 to 10 minutes at doses up to 20 mg/m2.
Croatian: Kyprolis je, kao monoterapija, primijenjen intravenski tijekom 2 do 10 minuta u dozama do 20 mg/m2.
English: Liver enzymes and bilirubin should be assessed at treatment initiation and monitored monthly during treatment with carfilzomib, regardless of baseline values, and appropriate dose modifications based on toxicity should be made (see table 3).
Croatian: Bez obzira na početne vrijednosti, enzimi jetre i bilirubin trebaju se procijeniti prilikom započinjanja liječenja i pratiti tijekom liječenja karfilzomibom na mjesečnoj razini, te je potrebno provesti odgovarajuće prilagodbe doze na temelju toksičnosti (vidjeti Tablicu 3).
English: Kyprolis causes thrombocytopenia with platelet nadirs observed on day 8 or day 15 of each 28-day cycle with recovery to baseline platelet count by the start of the next cycle (see section 4.8).
Croatian: Kyprolis uzrokuje trombocitopeniju s najnižim vrijednostima trombocita opaženima 8. ili 15. dana u svakom 28-dnevnom ciklusu uz oporavak na početne vrijednosti broja trombocita do početka sljedećeg ciklusa (vidjeti dio 4.8).
English: A cross-study comparison of the adverse reactions occurring in the Kyprolis and dexamethasone (Kd) arm of study 2011-003 vs the Kyprolis, lenalidomide and dexamethasone (KRd) arm of study PX-171-009 suggest that there may be a potential dose relationship for the following adverse reactions: cardiac failure (Kd 8.2%, KRd 6.4%), dyspnoea (Kd 30.9%, KRd 22.7%), hypertension (Kd 25.9%, KRd 15.8%), and pulmonary hypertension (Kd 1.3%, KRd 0.8%).
Croatian: Usporedbom ispitivanja s obzirom na nuspojave koje su se dogodile u Kd (Kyprolis i deksametazon) skupini ispitivanja 2011-003 naspram KRd (Kyprolis, lenalidomid i deksametazon) skupine u ispitivanju PX-171-009 ukazuje na moguću povezanost doze sa sljedećim nuspojavama: zatajenje srca (Kd 8,2%, KRd 6,4%), dispneja (Kd 30,9%, KRd 22,7%), hipertenzija (Kd 25,9%, KRd 15,8%) i plućna hipertenzija (Kd 1,3%, KRd 0,8%).
English: The second study was conducted in 23 relapsed multiple myeloma patients with creatinine clearance ≥ 75 mL/min (n = 13) and patients with end stage renal disease (ESRD) requiring dialysis (n = 10).
Croatian: Drugo ispitivanje provedeno je na 23 bolesnika s recidivirajućim multiplim mijelomom koji su imali klirens kreatinina ≥75 ml/min (n = 13) i bolesnika sa završnim stadijem bolesti bubrega (ZSBB) kojima je potrebna dijaliza (n = 10).
English: • Low red blood cell count (anaemia) which may cause tiredness and fatigue
Croatian: • Niska razina crvenih krvnih stanica (anemija), što može uzrokovati umor
English: Infusion reactions, including life-threatening reactions, have been reported in patients who received Kyprolis.
Croatian: Reakcije povezane s infuzijom, uključujući i po život opasne reakcije, prijavljene su u bolesnika u kojih je primjenjivan lijek Kyprolis.
English: Dose adjustments do not need to be made for weight changes of ≤ 20%.
Croatian: Prilagodba doze nije potrebna za promjene tjelesne težine