natgillin/translations-raw huggingface dataset:
• Lung problems, including a history of shortness of breath at rest or with activity (dyspnoea) 
• Problemi s plućima, uključujući povijest nedostatka zraka u mirovanju ili tijekom aktivnosti (dispneja)
Powder vial (unopened) 
Bočica s praškom (neotvorena)
Tell your doctor right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes. 
Odmah obavijestite svog liječnika ako vam se pojača umor ili u slučaju pojave žute boje kože ili bjeloočnica.
Patients with known risk factors for thromboembolism - including prior thrombosis - should be closely monitored. 
Bolesnike s poznatim čimbenicima rizika za tromboemboliju - uključujući prethodnu trombozupotrebno je pomno pratiti.
The reconstituted product should be a clear, colourless to slightly yellow solution and should not be administered if any discolouration or particulate matter is observed. 
Rekonstituirani lijek treba biti bistra, bezbojna do žućkasta otopina i ne smije se primjenjivati ako se opazi bilo kakva promjena boje ili prisutnost čestica.
95% CI of ORR 1-sided p-valueb 
95% CI od ORR Jednostrana p-vrijednostb
PRES, formerly termed reversible posterior leukoencephalopathy syndrome (RPLS), is a rare, neurological disorder, which can present with seizure, headache, lethargy, confusion, blindness, altered consciousness, and other visual and neurological disturbances, along with hypertension, and the diagnosis is confirmed by neuro-radiological imaging. 
PRES, ranije zvan i sindrom posteriorne reverzibilne leukoencefalopatije (RPLS, od engl. reversible posterior leukoencephalopathy syndrome), rijedak je neurološki poremećaj u kojem se mogu javiti napadaji, glavobolja, letargija, konfuzija, sljepoća, poremećaji svijesti i drugi poremećaji vida i neurološki poremećaji, zajedno s hipertenzijom, a dijagnoza se potvrđuje slikovnim neuro-radiološkim oslikavanjem.
Proportion surviving without progression 
Udio preživljenja bez progresije bolesti
• Stop dose and continue monitoring renal function (serum creatinine or creatinine clearance) Kyprolis should be resumed when renal function has recovered to within 25% of baseline; consider resuming at 1 dose level reductiona 
• Prekinite liječenje i nastavite pratiti bubrežnu funkciju (kreatinin u serumu ili klirens kreatinina) Nastavite liječenje lijekom Kyprolis kada se bubrežna funkcija oporavi na 25% početne vrijednosti; razmotrite nastavak liječenja smanjenjem doze za 1 razinua
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 
Sav neiskorišteni lijek ili otpadni materijal treba se zbrinuti u skladu s lokalnim zahtjevima.
The systemic clearance ranged from 151 to 263 L/hour, and exceeded hepatic blood flow, suggesting that carfilzomib was largely cleared extrahepatically. 
Sistemski klirens bio je u rasponu od 151 do 263 l/sat i nadilazio je protok krvi u jetri, što upućuje da se karfilzomib uvelike eliminira van jetre.
Kyprolis is administered at a starting dose of 20 mg/m2 (maximum dose 44 mg) in cycle 1 on days 1 and 2. 
Kyprolis se primjenjuje u početnoj dozi od 20 mg/m2 (maksimalna doza 44 mg) u 1. ciklusu 1. i 2. dana.
Each vial contains 10 mg, 30 mg or 60 mg of carfilzomib. 
Svaka bočica sadrži 10 mg, 30 mg ili 60 mg karfilzomiba.
6.6 Special precautions for disposal and other handling General precautions 
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Opće mjere opreza
Death due to cardiac arrest has occurred within a day of Kyprolis administration and fatal outcomes have been reported with cardiac failure and myocardial infarction. 
Do smrti uzrokovane zastojem srca došlo je unutar jednog dana od primjene lijeka Kyprolis i prijavljeni su smrtni ishodi uz zatajenje srca i infarkt miokarda.
• High blood pressure (hypertension) 
• Visok krvni tlak (hipertenzija)
It is unknown whether carfilzomib or its metabolites are excreted in human milk. 
Nije poznato izlučuju li se karfilzomib ili njegovi metaboliti u majčino mlijeko u ljudi.
• Heart attack 
• Srčani udar
• Infection of the stomach and intestine (gastroenteritis) 
• Infekcije želuca i crijeva (gastroenteritis)
In the first study the M14 metabolite, a peptide fragment and the most abundant circulating metabolite, increased 2- and 3-fold in patients with moderate and severe renal impairment, respectively, and 7-fold in patients requiring dialysis (based on AUClast). 
U prvom ispitivanju M14 metabolit, peptidni fragment i najobilniji metabolit u cirkulaciji, povećao se dvaput u bolesnika s umjerenim i triput u bolesnika s teškim oštećenjem bubrega, i sedam puta u bolesnika kojima je bila potrebna dijaliza (temeljeno na AUClast).
Study eligibility criteria allowed patients previously treated with carfilzomib (n = 3) or bortezomib (n = 502) to be enrolled as long as patients had at least a partial response (PR) to prior proteasome inhibitor therapy, were not removed from proteasome inhibitor therapy due to toxicity, and had at least a 6-month proteasome inhibitor treatment-free interval from last dose. 
Kriteriji podobnosti za ispitivanje omogućili su i uključivanje bolesnika koji su prethodno liječeni karfilzomibom (n = 3) ili bortezomibom (n = 502), uz uvjet da su bolesnici imali barem djelomičan odgovor na prethodno liječenje inhibitorom proteasoma, da liječenje inhibitorom proteasoma nije bilo prekinuto zbog toksičnosti i da je od posljednje doze prošlo razdoblje od najmanje 6 mjeseci u kojem nisu primali inhibitor proteasoma.
The study did not meet its primary efficacy endpoint of demonstrating superiority of Kyprolis monotherapy over the active control arm in overall survival (HR = 0.975 [95% CI: 0.760-1.249]). 
Ispitivanje nije postiglo svoj primarni ishod djelotvornosti dokazivanja superiornosti monoterapije lijekom Kyprolis u odnosu na aktivnu kontrolnu skupinu s obzirom na sveukupno preživljenje (HR = 0,975 [95% CI: 0,760 - 1,249]).
Instructions for reconstitution and preparation of Kyprolis powder for solution for infusion for intravenous administration 
Upute za rekonstituciju i pripremu Kyprolis praška za otopinu za infuziju za intravensku primjenu
Treatment with Kyprolis combined with lenalidomide and dexamethasone for longer than 18 cycles should be based on an individual benefit/risk assessment, as the data on the tolerability and toxicity of carfilzomib beyond 18 cycles are limited (see section 5.1). 
Kombinirano liječenje lijekom Kyprolis te lenalidomidom i deksametazonom u trajanju duljem od 18 ciklusa treba se zasnivati na pojedinačnoj procjeni omjera koristi i rizika, s obzirom na ograničene podatke o toksičnosti i podnošljivosti nakon 18 ciklusa (vidjeti dio 5.1).
25 mg daily Cycles 2-12 
25 mg dnevno Ciklusi 2. - 12.
It cannot be excluded that the efficacy of oral contraceptives may be reduced during carfilzomib treatment (see section 4.5). 
Ne može se isključiti mogućnost smanjenja djelotvornosti oralnih kontraceptiva tijekom liječenja karfilzomibom (vidjeti dio 4.5).
Subsequently patients should be treated with caution and remain under close follow-up. 
Posljedično, u liječenju bolesnika potreban je oprez i pomno praćenje.
While you are being treated with Kyprolis you may experience fatigue, dizziness, fainting, and/or a drop in blood pressure. 
Tijekom liječenja lijekom Kyprolis možete osjećati umor, omaglicu, nesvjesticu i/ili pad krvnog tlaka.
As Kyprolis is administered in combination with other medicinal products, the summary of product characteristics of these other medicinal products must be consulted prior to initiation of treatment with Kyprolis. 
S obzirom da se Kyprolis primjenjuje u kombinaciji s drugim lijekovima, sažetci opisa svojstava lijeka tih drugih lijekova moraju se proučiti prije započinjanja liječenja lijekom Kyprolis.
Carfilzomib was not mutagenic in the in vitro bacterial reverse mutation (Ames) test and was not clastogenic in the in vivo mouse bone marrow micronucleus assay. 
Karfilzomib nije bio mutagen u in vitro testu reverznih mutacija kod bakterija (Amesov test) i nije bio klastogen u in vivo mikronukleus testu na stanicama koštane srži miševa.
The highest non-severely toxic dose of 0.5 mg/kg in monkeys resulted in interstitial inflammation in the kidney along with slight glomerulopathy and slight heart inflammation. 
Najviša doza koja nije bila teško toksična, od 0,5 mg/kg, u majmuna je rezultirala intersticijskom upalom u bubrezima, uz blagu glomerulopatiju i blagu upalu srca.
Study eligibility criteria allowed a small subset of patients with myeloma refractory to bortezomib (n = 118) or lenalidomide (n = 57) to be enrolled. 
Kriteriji podobnosti za ispitivanje omogućili su uključivanje u ispitivanje maloj podskupini bolesnika s mijelomom otpornim na bortezomib (n = 118) ili lenalidomid (n = 57).
An effect of Kyprolis on QT interval cannot be excluded (see section 5.1). 
Ne može se isključiti učinak lijeka Kyprolis na produljenje QT intervala (vidjeti dio 5.1).
• Difficulty breathing, rapid breathing and/or fingertips and lips looking slightly blue (acute respiratory distress syndrome) 
• Otežano disanje, ubrzano disanje i/ili blago plavo obojeni prsti i usnice (akutni respiratorni distres sindrom)
Cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported in patients receiving carfilzomib who have had prior or concurrent immunosuppressive therapy. 
Zabilježeni su slučajevi progresivne multifokalne leukoencefalopatije (PML) u bolesnika koji su primali karfilzomib i koji su se prethodno ili istodobno liječili imunosupresivima.
Carfilzomib had antiproliferative and proapoptotic activities in preclinical models in haematologic tumours. 
Karfilzomib je imao antiproliferativno i proapoptotičko djelovanje u pretkliničkim modelima hematoloških tumora.
For women taking Kyprolis 
Za žene koje uzimaju Kyprolis
PX-171-011 evaluated Kyprolis monotherapy versus a control arm (corticosteroids and cyclophosphamide). 
U ispitivanju PX-171-011 procijenjena je monoterapija lijekom Kyprolis u odnosu na kontrolnu skupinu (kortikosteridi i ciklofosfamid).
After reconstitution, 1 mL of solution contains 2 mg of carfilzomib. 
Nakon rekonstitucije, 1 ml otopine sadrži 2 mg karfilzomiba.
Kyprolis (mg/m2) Dexamethasone (mg) 
Kyprolis (mg/m2) Deksametazon (mg)
Male patients must use effective contraception measures during and for 3 months following treatment if their partner is pregnant or of childbearing potential and not using effective contraception (refer to section 4.6). 
Muški bolesnici moraju primjenjivati učinkovite mjere kontracepcije tijekom i 3 mjeseca nakon liječenja, ako je njihova partnerica trudna ili reproduktivne dobi, a ne koristi učinkovitu kontracepciju (pogledajte dio 4.6).
Platelet counts should be monitored frequently during treatment with Kyprolis. 
Broj trombocita potrebno je često pratiti tijekom primjene lijeka Kyprolis.
A number of cases of Hepatitis B reactivation have been identified in relation to carfilzomib treatment. 
Utvrđeno je više slučajeva reaktivacije hepatitisa B u vezi s liječenjem karfilzomibom.
Serum potassium levels should be monitored monthly, or more frequently during treatment with Kyprolis as clinically indicated and will depend on the potassium levels measured before the start of treatment, concomitant therapy used (e.g. medicinal products known to increase the risk of hypokalaemia) and associated comorbidities. 
Tijekom liječenja lijekom Kyprolis potrebno je pratiti razinu kalija u serumu na mjesečnoj razini ili češće, kako je klinički indicirano, što će ovisiti o razinama kalija izmjerenima prije početka liječenja, istodobno primjenjivanim lijekovima (npr. lijekovi za koje je poznato da povećavaju rizik od hipokalijemije) i povezanim komorbiditetima.
Those findings were reported at 6 mg/m2 which are below the recommended dose in humans of 27 mg/m2. 
Ovi su rezultati prijavljeni pri dozi od 6 mg/m2, što je manje od preporučene doze od 27 mg/m2 u ljudi.
You must look out for certain symptoms while you are taking Kyprolis to reduce the risk of any problems. 
Tijekom uzimanja lijeka Kyprolis morate obraćati pozornost na neke simptome kako bi se smanjio rizik nastanka problema.
• Numbness, tingling, or decreased sensation in hands and/or feet 
• Utrnulost, trnci ili smanjen osjet u šakama i/ili stopalima
If you become pregnant while taking Kyprolis, notify your doctor or nurse immediately. 
Ako tijekom primjene lijeka Kyprolis zatrudnite, odmah obavijestite svog liječnika ili medicinsku sestru.
25 mg daily Cycles 13 on 
25 mg dnevno Ciklus 13. i nadalje
• A side effect called tumour lysis syndrome, which can be caused by the rapid breakdown of tumour cells and may cause irregular heartbeat, kidney failure or abnormal blood test results 
• Nuspojava zvana sindrom lize tumora, koju može uzrokovati brza razgradnja tumorskih stanica i koja može uzrokovati nepravilne otkucaje srca, zatajenje bubrega ili abnormalne rezultate krvnih pretraga
Cases of hepatic failure, including fatal cases, have been reported in < 1% of subjects in clinical studies with Kyprolis. 
Slučajevi zatajenja jetre, uključujući smrtne slučajeve, prijavljeni su u < 1% ispitanika u kliničkim ispitivanjima lijeka Kyprolis.
Dizziness Peripheral neuropathy Headache 
Omaglica Periferna neuropatija Glavobolja
Patients with signs or symptoms of NYHA Class III or IV cardiac failure, recent history of myocardial infarction (in the last 4 months), and in patients with uncontrolled angina or arrhythmias, should have a comprehensive cardiological assessment, prior to starting treatment with Kyprolis. 
U bolesnika sa znakovima ili simptomima zatajenja srca NYHA klase III ili IV, nedavnom povijesti infarkta miokarda (u posljednja 4 mjeseca) te bolesnika s nekontroliranom anginom ili aritmijama treba se provesti sveobuhvatna kardiološka procjena prije početka primjene lijeka Kyprolis.
• Redness of the skin 
• Svrbež kože
The dose of 2 mg/kg/dose in rats is approximately half the recommended dose in humans of 27 mg/m2 based on BSA. 
Doza od 2 mg/kg/dozi u štakora odgovara otprilike polovici preporučene doze od 27 mg/m2 u ljudi, koja se temelji na BSA.
If you are given too much Kyprolis 
Ako primite previše lijeka Kyprolis
Patients randomised to the Vd arm could receive bortezomib either by the intravenous (n = 108) or subcutaneous (n = 357) route. 
Bolesnici koji su randomizirani u Vd skupinu bortezomib su mogli primiti ili intravenskim (n = 108) ili supkutanim (n = 357) putem.
• Stop dose If recovered to ≥ 10 x 109/L and/or bleeding is controlled continue at same dose level 
Ako se vrati na vrijednosti ≥ 10 x 109/l i/ili je krvarenje pod kontrolom, nastavite jednakom dozom
Hypertensive crisis 
Hipertenzivna kriza
Experts in the treatment of HBV infection should be consulted, as necessary. 
Po potrebi se treba savjetovati sa stručnjacima za liječenje infekcije HBV-om.
Kyprolis causes thrombocytopenia through inhibition of platelet budding from megakaryocytes resulting in a classic cyclical thrombocytopenia with platelet nadirs occurring on day 8 or 15 of each 28-day cycle and usually associated with recovery to baseline by the start of the next cycle. 
Kyprolis uzrokuje trombocitopeniju inhibirajući pupanje trombocita iz megakariocita, što je rezultiralo klasičnom cikličkom trombocitopenijom s najnižim vrijednostima trombocita 8. ili 15. dana u svakom 28-dnevnom ciklusu i obično je povezana s oporavkom na početne vrijednosti do početka sljedećeg ciklusa.
In clinical studies, hypertension adverse events occurred in approximately 20% of subjects and 7.5% of subjects had grade ≥ 3 hypertension events, but hypertensive crises occurred in < 0.5% of subjects. 
U kliničkim ispitivanjima, hipertenzivni štetni događaji javili su se u otprilike 20% ispitanika i 7,5% ispitanika imalo je događaj hipertenzije 3. ili višeg stupnja, dok se hipertenzivna kriza javila u < 0,5% ispitanika.
Creatinine clearance was stable over time for the majority of patients. 
U većine bolesnika, klirens kreatinina je bio stabilan tijekom vremena.
While adequate hydration is required prior to dosing in cycle 1, all patients should be monitored for evidence of volume overload, especially patients at risk for cardiac failure. 
S obzirom da je prije doziranja u 1. ciklusu potrebna odgovarajuća hidracija, sve bolesnike mora se pratiti zbog utvrđivanja volumnog preopterećenja, posebno bolesnike s rizikom zatajenja srca.
In clinical studies with Kyprolis, cardiac toxicity and dyspnoea typically occurred early in the course of Kyprolis therapy (see section 4.4). 
U kliničkim ispitivanjima lijeka Kyprolis kardiološka toksičnost i dispneja obično su se javile rano u tijeku liječenja lijekom Kyprolis (vidjeti dio 4.4).
Based on high number of cases, plausible mechanism and seriousness of the risk, hepatitis B reactivation is proposed to be added as an adverse drug reaction in the SmPC and PL. A relevant warning should also be included. 
Na temelju velikog broja slučajeva, mogućeg mehanizma i ozbiljnosti rizika, predloženo je dodavanje reaktivacije hepatitisa B kao nuspojave u sažetak opisa svojstava lijeka i informacije o lijeku.
Carfilzomib was clastogenic in the in vitro chromosomal aberration test in peripheral blood lymphocytes. 
Karfilzomib je bio klastogen u in vitro testu kromosomskih aberacija u limfocitima periferne krvi.
Hypertensive emergency 
Hipertenzivna hitnost
Adequate hydration is required before dose administration in cycle 1, especially in patients at high risk of tumour lysis syndrome or renal toxicity. 
Prije primjene doze u 1. ciklusu potrebna je odgovarajuća hidracija, posebno u bolesnika s visokim rizikom od sindroma lize tumora ili bubrežne toksičnosti.
Overall, the subject incidence of certain adverse events (including cardiac arrhythmias, cardiac failure (see section 4.4), dyspnoea, leukopenia and thrombocytopenia) in clinical trials with Kyprolis was higher for patients who were ≥ 75 years of age compared to patients who were < 75 years of age. 
Sveukupno, incidencija određenih štetnih događaja u ispitanika (uključujući srčane aritmije, zatajenje srca (vidjeti dio 4.4), dispneju, leukopeniju i trombocitopeniju) u kliničkim ispitivanjima lijeka Kyprolis bila je viša za bolesnike u dobi od ≥ 75 godina u usporedbi s bolesnicima u dobi od < 75 godina.
Cases of Hepatitis B Virus (HBV) reactivation have been reported in patients receiving carfilzomib. 
Zabilježeni su slučajevi reaktivacije virusa hepatitisa B (HBV) u bolesnika koji su primali karfilzomib.
Following initial doses of carfilzomib at 20 mg/m2, the dose was increased to 27 mg/m2 in study PX-171-009 and to 56 mg/m2 in study 2011-003 (see section 5.1). 
Nakon početnih doza karfilzomiba od 20 mg/m2, doza je povećana na 27 mg/m2 u ispitivanju PX-171-009 te na 56 mg/m2 u ispitivanju 2011-003 (vidjeti dio 5.1).
• Inflammation of the colon caused by a bacteria called Clostridium difficile 
• Upala crijeva uzrokovana bakterijom Clostridium difficile
Dexamethasone should be administered prior to Kyprolis to reduce the incidence and severity of reactions (see section 4.2). 
Deksametazon je potrebno primijeniti prije lijeka Kyprolis kako bi se smanjila incidencija i težina reakcija (vidjeti dio 4.2).
• Serious lung infection (pneumonia) 
• Ozbiljna infekcija pluća (upala pluća)
Overall, the subject incidence of certain adverse events (including cardiac failure) in clinical trials was higher for patients who were ≥ 75 years of age compared to patients who were < 75 years of age (see section 4.4). 
Sveukupno, u kliničkim ispitivanjima je incidencija pojedinih štetnih događaja po ispitaniku (uključujući zatajenje srca) bila viša u bolesnika u dobi od ≥ 75 godina u usporedbi s bolesnicima u dobi od < 75 godina (vidjeti dio 4.4).
A pre-planned second interim OS analysis was performed after 189 deaths in the Kd arm and 209 deaths in the Vd arm. At the time of the analysis, 80% of the targeted events were registered. 
Prethodno planirana druga interim OS analiza učinjena je nakon 189 smrtnih slučajeva u Kd skupini i 209 smrtnih slučajeva u Vd skupini.
Renal function should be assessed at treatment initiation and monitored at least monthly or in accordance with accepted clinical practice guidelines, particularly in patients with lower baseline creatinine clearance (CrCL < 30 mL/min). 
Funkciju bubrega potrebno je procijeniti prilikom započinjanja liječenja i pratiti najmanje na mjesečnoj razini ili u skladu s prihvaćenim smjernicama kliničke prakse, posebno u bolesnika s nižim početnim klirensom kreatinina (CrCL < 30 ml/min).
In clinical studies with Kyprolis, cardiac failure was reported in approximately 7% of subjects (5% of subjects had grade ≥ 3 events), myocardial infarction was reported in approximately 2% of subjects (1.5% of subjects had grade ≥ 3 events) and myocardial ischaemia was reported in approximately 1% of subjects (< 1% of subjects had grade ≥ 3 events). 
U kliničkim ispitivanjima lijeka Kyprolis, zatajenje srca je bilo prijavljeno u otprilike 7% ispitanika (5% ispitanika imalo je događaj 3. ili višeg stupnja), infarkt miokarda je bio prijavljen u otprilike 2% ispitanika (1,5% ispitanika imalo je događaj 3. ili višeg stupnja), a ishemija miokarda je bila prijavljena u otprilike 1% ispitanika (< 1% ispitanika imalo je događaj 3. ili višeg stupnja).
Carfilzomib may decrease the efficacy of oral contraceptives (refer to section 4.5). 
Karfilzomib može smanjiti djelotvornost oralnih kontraceptiva (pogledajte dio 4.5).
• Leg or arm pain or swelling (which could be a symptom of blood clots in the deep veins of the leg or arm), chest pain or shortness of breath (which may be a symptom of blood clots in the lungs) 
• Bol ili oticanje nogu ili ruku (što može biti simptom krvnih ugrušaka u dubokim venama nogu ili ruku), bolovi u prsnom košu ili nedostatak zraka (što može biti simptom krvnih ugrušaka u plućima)
Kyprolis in combination with either lenalidomide and dexamethasone or dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1). 
Kyprolis u kombinaciji s lenalidomidom i deksametazonom ili u kombinaciji samo s deksametazonom indiciran je za liječenje odraslih bolesnika s multiplim mijelomom koji su prethodno primili najmanje jednu terapiju (vidjeti dio 5.1).
If tolerated, the dose should be increased on day 8 of cycle 1 to 56 mg/m2 (maximum dose 123 mg). 
Ako se doza podnosi treba ju 8. dana 1. ciklusa povećati do 56 mg/m2 (maksimalna doza 123 mg).
Adverse reactions are presented below by system organ class and frequency category (table 5). 
Nuspojave su prikazane niže prema klasifikaciji organskih sustava i prema kategoriji učestalosti (Tablica 5).
• For subsequent drops to < 10 x 109/L, follow the same recommendations as above and consider 1 dose level reduction when restarting Kyprolisa 
• Za naknadna smanjenja na vrijednosti < 10 x 109/l slijedite iste preporuke kao što je gore opisano i razmotrite smanjenje doze za 1 razinu prilikom ponovnog uvođenja lijeka Kyprolisa
Proportion Surviving 
Udio preživljenja
Remove vial from refrigerator just prior to use. 
Neposredno prije primjene izvadite bočicu iz hladnjaka.
Thus, there are limited data for Kyprolis in combination with lenalidomide and dexamethasone in patients with creatinine clearance (CrCL < 50 mL/min). 
Stoga, su podaci o primjeni lijeka Kyprolis u kombinaciji s lenalidomidom i deksametazonom u bolesnika s klirensom kreatinina (CrCL < 50 ml/min) ograničeni.
• Platelet count < 10 x 109/L or evidence of bleeding with thrombocytopenia (see section 4.4) 
• Broj trombocita < 10 x 109/l ili dokaz krvarenja uz trombocitopeniju (vidjeti dio 4.4)
Very common side effects (may affect more than 1 in 10 people) 
Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 bolesnika)
• Hepatitis B infection activated again (viral inflammation of the liver) 
• Ponovno aktiviranje infekcije hepatitisom B (virusna upala jetre)
• For subsequent drops to < 0.5 x 109/L, follow the same recommendations as above and consider 1 dose level reduction when restarting Kyprolisa 
• Za naknadna smanjenja na vrijednosti < 0,5 x 109/l slijedite iste preporuke kao što je gore opisano i razmotrite smanjenje doze za 1 razinu prilikom ponovnog uvođenja lijeka Kyprolisa