natgillin/translations-raw huggingface dataset:
Ivozall is a potent antineoplastic agent with potentially significant haematological and non-haematological adverse reactions (see section 4.8). 
Zdravilo Ivozall je močan antineoplastik z morebitno pomembnimi hematološkimi in nehematološkimi neželenimi učinki (glejte poglavje 4.8).
Systemic clearance 
Sistemski očistek
Patients should be instructed to seek medical advice if they experience symptoms of dizziness, fainting spells, or decreased urine output. 
Bolnikom je treba naročiti, naj se posvetujejo z zdravnikom, če imajo simptome omotice, omedlevice ali zmanjšanega uriniranja.
The safety and efficacy of clofarabine were evaluated in a phase I, open-label, non-comparative, doseescalation study in 25 paediatric patients with relapsed or refractory leukaemia (17 ALL; 8 AML) who had failed standard therapy or for whom no other therapy existed. 
Varnost in učinkovitost klofarabina so ocenili v odprti, neprimerjalni študiji s povečevanjem odmerka 1. faze, pri 25 pediatričnih bolnikih s ponovljeno ali neodzivno levkemijo (17 ALL; 8 AML), pri katerih standardno zdravljenje ni bilo uspešno ali pri katerih ni bilo drugega zdravljenja.
The majority of the cases were associated with thrombocytopaenia (see section 4.8). 
Večina primerov je bila povezanih s trombocitopenijo (glejte poglavje 4.8).
Instructions for handling 
Navodila za ravnanje
The most prevalent renal toxicity in paediatric patients was elevated creatinine. 
Prevladujoča oblika ledvične toksičnosti pri pediatričnih bolnikih je bila povišana vrednost kreatinina.
Patients with ALL must not have been eligible for therapy of higher curative potential and must have been in second or subsequent relapse and/or refractory i.e. failed to achieve remission after at least two prior regimens. 
Bolniki z ALL niso smeli biti primerni za zdravljenje z večjo možnostjo ozdravitve in so morali biti najmanj v drugem relapsu in/ali imeti neodzivno bolezen, tj. pri njih ni prišlo do remisije po najmanj dveh prejšnjih zdravljenjih.
In addition, clofarabine possesses greater resistance to cellular degradation by adenosine deaminase and decreased susceptibility to phosphorolytic cleavage than other active substances in its class whilst the affinity of clofarabine triphosphate for DNA polymerase α and ribonucleotide reductase is similar to or greater than that of deoxyadenosine triphosphate. 
Poleg tega je klofarabin odpornejši na razgradnjo z adenozin deaminazo v celici in je manj dovzeten za fosforolitično cepljenje kot druge učinkovine v tej skupini zdravil, medtem ko je afiniteta klofarabin trifosfata za DNA-polimerazo α in ribonukleotid-reduktazo podobna ali večja kot pri deoksiadenozin trifosfatu.
Very common: Febrile neutropenia Common: Neutropenia 
Zelo pogosti: febrilna nevtropenija Pogosti: nevtropenija
Volume of distribution (steady state) 
Volumen porazdelitve (ravnotežno stanje)
Clofarabine is a purine nucleoside anti-metabolite. 
Klofarabin je antimetabolit nukleozida purina.
Cardiac effects were observed in rats consistent with cardiomyopathy and contributed to signs of cardiac failure after repeated cycles of treatment. 
Pri podganah so opazili učinke na srce, ki so sovpadali s kardiomiopatijo in so prispevali k znakom srčne odpovedi po več ciklih zdravljenja.
Very common: Palmar-plantar erythrodysaesthesia syndrome, pruritus 
Zelo pogosti: sindrom palmarno-plantarne eritrodisestezije, srbenje
Common: Contusion 
Pogosti: kontuzija
There is no clinical study experience in paediatric patients with renal insufficiency (defined in clinical studies as serum creatinine ≥ 2 x ULN for age) and clofarabine is predominately excreted via the kidneys. 
Ni izkušenj iz kliničnih študij pri pediatričnih bolnikih z okvarjenim ledvičnim delovanjem (v kliničnih študijah opredeljeno kot serumski kreatinin ≥ 2 x ULN za starost bolnika), klofarabin pa se izloča pretežno skozi ledvice.
Fifty percent of patients experienced at least one cardiac disorders adverse reaction. 
Pri petdesetih odstotkih bolnikov je prišlo do vsaj enega neželenega učinka v povezavi s srčnimi boleznimi.
Duration of Remission (weeks) 
trajanje remisije (tedni)
Thirteen events of tumour lysis syndrome, capillary leak syndrome or SIRS have been reported; SIRS (2 events; both were considered to be serious), capillary leak syndrome (4 events; 3 of which were considered serious and related) and tumour lysis syndrome (7 events; 6 of which were considered related and 3 of which were serious). 
Poročali so o trinajstih primerih sindroma tumorske lize, sindroma kapilarnih razpok ali SIRS; SIRS (2 dogodka; oba so ocenili kot resna), sindrom kapilarnih razpok (4 dogodki; 3 izmed njih so ocenili kot resne in povezane z zdravljenjem) in sindrom tumorske lize (7 dogodkov; 6 izmed njih so ocenili kot povezane z zdravljenjem in 3 izmed njih kot resne).
ORPHELIA Pharma 85 boulevard Saint-Michel 75005 PARIS France 
ORPHELIA Pharma 85 boulevard Saint-Michel 75005 PARIZ Francija
Common: Tumour lysis syndrome* 
Pogosti: sindrom tumorske lize*
Most patients received conditioning regimens that included busulfan, melphalan, and/or the combination of cyclophosphamide and total body irradiation. 
Večina bolnikov je prejela pripravljalno zdravljenje z busulfanom, melfalanom in/ali kombinacijo ciklofosfamida in obsevanjem celotnega telesa.
Those most frequently reported were nausea (61% of patients), vomiting (59%), febrile neutropaenia (35%), headache (24%), rash (21%), diarrhoea (20%), pruritus (20%), pyrexia (19%), palmar-plantar erythrodysaesthesia syndrome (15%), fatigue (14%), anxiety (12%), mucosal inflammation (11%), and flushing (11%). 
bolnikov), bruhanju (59 %), febrilni nevtropeniji (35 %), glavobolu (24 %), osipu (21 %), diareji (20 %), srbenju (20 %), pireksiji (19 %), sindromu palmarno-plantarne eritrodisestezije (15 %), utrujenosti (14 %), tesnobi (12 %), vnetju sluznice (11 %) in oblivanju (11 %).
As the effect of clofarabine treatment on human fertility is unknown, reproductive planning should be discussed with patients as appropriate. 
Učinek klofarabina na plodnost pri človeku ni znan, zato se je treba z bolnikom posvetovati o načrtovanju družine, kadar je to primerno.
Clofarabine clearance rates appear to be much higher than glomerular filtration rates suggesting filtration and tubular secretion as kidney elimination mechanisms. 
Hitrost očistka klofarabina je videti večja kot hitrost glomerularne filtracije, kar kaže na filtracijo in tubularno sekrecijo kot mehanizma izločanja skozi ledvice.
Patients who have previously received a hematopoietic stem cell transplant (HSCT) may be at higher risk for hepatotoxicity suggestive of veno-occlusive disease (VOD) following treatment with clofarabine (40 mg/m2) when used in combination with etoposide (100 mg/m2) and cyclophosphamide (440 mg/m2). 
Bolniki s predhodno presaditvijo krvotvornih matičnih celic (hematopoietic stem cell transplant, HSCT) so lahko izpostavljeni povišanemu tveganju za hepatotoksično sugestivno venookluzivno bolezen (veno-occlusive disease, VOD) po zdravljenju s klofarabinom (40 mg/m2), kadar se ta uporablja skupaj z etopozidom (100 mg/m2) in ciklofosfamidom (440 mg/m2).
Pericardial effusion and pericarditis were reported as an adverse reaction in 9% (10/115) of patients. 
O perikardnem izlivu in perikarditisu so poročali pri 9 % (10/115) bolnikov.
The threshold for developmental toxicity was considered to be 6 mg/m2/day in rats and 1.2 mg/m2/day in rabbits. 
Odmerek, pri katerem je prišlo do razvojne toksičnosti, je bil 6 mg/m2/dan pri podganah in 1,2 mg/m2/dan pri kuncih.
There are currently limited data on the safety and efficacy of clofarabine when administered for more than 3 treatment cycles. 
Podatki o varnosti in učinkovitosti klofarabina, kadar se odmerjajo več kot 3 cikli zdravljenja, so trenutno omejeni.
No relationship between clofarabine or clofarabine triphosphate exposure and either efficacy or toxicity has been established in this population. 
V tej populaciji niso ugotovili razmerja med izpostavljenostjo klofarabinu ali klofarabin trifosfatu ter učinkovitostjo ali toksičnostjo.
It was characterised by minor thickening of the glomerular basement membrane with only slight tubular damage and was not associated with changes in serum chemistry. 
Zanjo je bila značilna majhna odebelitev glomerularne bazalne membrane z rahlo okvaro tubulov, ni pa bila povezana s kemičnimi spremembami v serumu.
Efficacy results from the pivotal study in patients (≤ 21 years old at initial diagnosis) with relapsed or refractory ALL after at least two prior regimens 
Rezultati učinkovitosti iz ključne študije pri bolnikih (starih ≤ 21 let ob prvi diagnozi) s ponovljeno ali neodzivno ALL po vsaj dveh predhodnih zdravljenjih
Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, purine analogues, ATC code: L01BB06. 
(antimetaboliti), purinski analogi, oznaka ATC: L01BB06.
The vials contain 20 ml concentrate for solution for infusion and are packaged in a box. 
Viale vsebujejo 20 ml koncentrata za raztopino za infundiranje, pakirane pa so v škatlo.
If you are the parent of a child who is being treated with Ivozall, tell the doctor if any of them apply to your child. 
Če ste starši otroka, ki ga zdravijo z zdravilom Ivozall, obvestite zdravnika, če kateri koli od teh stanj velja za vašega otroka.
No studies on the effects of clofarabine on the ability to drive and use machines have been performed. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Študij o vplivu klofarabina na sposobnost vožnje in upravljanja strojev niso izvedli.
Patients who underwent transplant after alternative therapy or relapse* 
PR bolniki s presaditvijo po alternativnem zdravljenju ali relapsu* PRt
• Complete blood and platelet counts should be obtained at regular intervals, more frequently in patients who develop cytopaenias. 
• v rednih časovnih razmikih je treba opraviti pregled celotne krvne slike in štetje trombocitov, pogosteje pri bolnikih, pri katerih se pojavi citopenija;
Dose related toxicities on male reproductive organs have been observed in mice, rats and dogs, and toxicities on female reproductive organs have been observed in mice (see section 5.3). 
Toksične učinke na moške reproduktivne organe, odvisne od odmerka, so opazili pri miših, podganah in psih, toksične učinke na ženske reproduktivne organe pa pri miših (glejte poglavje 5.3).
Should patients experience an ANC < 0.5 × 109/l for more than 4 weeks from the start of the last cycle, it is recommended that the dose for the next cycle be reduced by 25%. 
Če je vrednost ANC pri bolnikih več kot 4 tedne od začetka zadnjega cikla < 0,5 × 109/l, se priporoča zmanjšanje odmerka v naslednjem ciklu za 25 %.
CRp = Complete remission in the Absence of Total Platelet Recovery 
PRt = Popolna remisija brez popolne obnovitve števila trombocitov
To date, the highest daily dose administered to human beings is 70 mg/m2 for 5 consecutive days (2 paediatric ALL patients). 
Največji odmerek, ki so ga odmerili pri človeku, je 70 mg/m2 5 dni zaporedoma (2 pediatrična bolnika z ALL).
Where follow-up data are available, the majority of bilirubin elevations returned to ≤ grade 2 
Podatki iz nadaljnjega spremljanja, kjer so na voljo, kažejo, da se je večina povišanih vrednosti bilirubina znižala na ≤ 2. stopnjo v 10 dneh.
Immediate discontinuation of therapy, careful observation and initiation of appropriate supportive measures are recommended. 
Specifičnega antidota ni. Priporočeni so prekinitev zdravljenja, skrbno spremljanje bolnika in izvajanje ustreznih podpornih ukrepov.
6.6 Special precautions for disposal and other handling 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Posebni pogoji za ravnanje
The toxicities observed in these patients included vomiting, hyperbilirubinaemia, elevated transaminase levels and maculo-papular rash. 
Med toksičnimi učinki, ki so jih opazili pri teh bolnikih, so bili bruhanje, hiperbilirubinemija, povečane vrednosti transaminaz in makulo-papularni izpuščaj.
Clofarabine may cause harm to unborn babies when used by pregnant women. 
Klofarabin lahko škoduje nerojenemu otroku, če ga jemlje nosečnica.
The vials contain 20 mg of clofarabine and are packaged in a box. 
Viale vsebujejo 20 mg klofarabina, pakirane pa so v škatlo.
PR = Partial remission 
PR = Popolna remisija
Individual duration remission and survival data for patients who achieved CR or CRp 
Posamično trajanje remisije in podatki o preživetju za bolnike, ki so dosegli PR ali PRt najboljši odgovor čas do SR
OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksično.
For storage conditions after dilution of the medicinal product, see section 6.3 
Za pogoje shranjevanja po redčenju zdravila glejte poglavje 6.3.
Dose-limiting toxicities in this study were hyperbilirubinaemia, elevated transaminase levels and maculo-papular rash experienced at 70 mg/m2/day (2 ALL patients; see section 4.9). 
Toksični učinki, ki so omejevali odmerjanje v tej študiji, so bili hiperbilirubinemija, povečane ravni transaminaz in makulo-papularni izpuščaj, ki so se pojavili pri odmerku 70 mg/m2/dan (2 bolnika z ALL; glejte poglavje 4.9).
There are currently insufficient data to establish the safety and efficacy of clofarabine in patients 65 years of age or older. 
Trenutno ni na voljo dovolj podatkov, da bi ocenili varnost in učinkovitost klofarabina pri bolnikih, starih 65 ali starejših.
This is equivalent to 3.08 mmol (or 70.77 mg) of sodium which is equivalent to 3.53% of the WHO recommended maximum daily intake of 2 g sodium for an adult and should be taken into consideration for patients on a controlled sodium diet. 
To ustreza 3,08 mmol (ali 70,77 mg) natrija, kar ustreza 3,53 % priporočenega največjega dnevnega vnosa, ki ga priporoča SZO in pri odraslih znaša
If a patient becomes pregnant during treatment with clofarabine, she should be informed of the possible hazard to the foetus. 
Če bolnica med zdravljenjem s klofarabinom zanosi, jo je treba obvestiti o morebitnih tveganjih za plod.
In addition, clofarabine delayed tumour growth and, in some cases, caused tumour regression in an assortment of human and murine tumour xenografts implanted in mice. 
Poleg tega je upočasnil rast tumorjev ter v nekaterih primerih povzročil regresijo tumorjev pri različnih človeških in glodavskih heterolognih transplantatih, presajenih na miši.
Ivozall is for single use only. 
Zdravilo Ivozall je samo za enkratno uporabo.
Three of these events were subsequently assessed as being related to clofarabine: pericardial effusion (2 events; 1 of which was serious) and pericarditis (1 event; not serious). 
Tri izmed teh dogodkov so naknadno ocenili, da so povezani s klofarabinom: perikardni izliv (2 dogodka; od tega 1 resen) in perikarditis (1 dogodek; ni bil resen).
However, the pericardial effusion was clinically significant in 2 patients with some associated haemodynamic compromise. 
Perikardni izliv je bil klinično pomemben pri 2 bolnikih, pri katerih je bil do določene mere povezan z ogroženo hemodinamiko.
Median time to progression (weeks)** (95% CI) 
Mediana časa do napredovanja bolezni (tedni)** (IZ 95 %)
Therapy must be initiated and supervised by a physician experienced in the management of patients with acute leukaemias. 
4.2 Odmerjanje in način uporabe Zdravljenje mora začeti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z akutnimi levkemijami.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/20 ml 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 20 mg/20 ml
Cytotoxic medicinal products should be handled with caution. 
S citotoksičnimi zdravili morate ravnati previdno.
The liver is a potential target organ for toxicity. 
Jetra so potencialna tarča za toksične učinke klofarabina.
To date, there are limited data on the pharmacokinetics of clofarabine in paediatric patients with decreased creatinine clearance. 
Okvara ledvic Do sedaj še ni dovolj podatkov o farmakokinetiki klofarabina pri pediatričnih bolnikih z zmanjšanim kreatininskim očistkom.
A 25% dose reduction may be warranted in patients experiencing significant toxicities (see below). 
Pri bolnikih z izrazitimi toksični učinki lahko uporabite 25 % manjši odmerek (glejte spodaj).
ALT and AST occurred within 10 days of clofarabine administration and returned to ≤ grade 2 within 15 days. 
Do večine pojavov povišanih vrednosti ALT in AST je prišlo v 10 dneh po odmerjanju klofarabina ter so se znižale na ≤ 2. stopnjo v 15 dneh.
Should a patient experience the same severe toxicity on a second occasion, treatment should be delayed until the toxicity resolves to baseline parameters or to the point where it is no longer severe and the potential benefit of continued treatment with clofarabine outweighs the risk of such continuation. 
Če se pri bolniku znova pojavijo enako hudi toksični učinki, je treba zdravljenje prestaviti, dokler se toksični učinki ne vrnejo na izhodiščne parametre ali do točke, ko niso več hudi in je morebitna korist nadaljevanja zdravljenja s klofarabinom večja od tveganja.
Twenty-one (18.3%) events were considered to be related to clofarabine of which catheter related infection (1 event), sepsis (2 events) and septic shock (2 events; 1 patient died (see above)) were considered to be serious. 
Za enaindvajset dogodkov (18,3 %) so menili, da so povezani z zdravljenjem s klofarabinom, med njimi so za okužbo, povezano s katetrom (1 dogodek), sepso (2 dogodka) in septični šok (2 dogodka; 1 bolnik je umrl (glejte zgoraj) menili, da so resni.
If the product comes into contact with eyes, skin or mucous membranes, rinse immediately with copious amounts of water. 
Če zdravilo pride v stik z očmi, kožo ali sluznicami, takoj izperite z obilo vode.
Three patients died of adverse events considered by the study investigator to be related to treatment with clofarabine: one patient died from respiratory distress, hepatocellular damage, and capillary leak syndrome; one patient from VRE sepsis and multi-organ failure; and one patient from septic shock and multi-organ failure. 
Trije bolniki so umrli zaradi neželenih dogodkov, za katere je raziskovalec v klinični študiji menil, da so posledica zdravljenja s klofarabinom: en bolnik zaradi respiratornega distresa, okvare jetrnih celic in sindroma kapilarnih razpok; en bolnik zaradi sepse VRE in odpovedi več organov; in en bolnik zaradi septičnega šoka in odpovedi več organov.
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), including fatal cases, have been reported (see section 4.8). 
Poročali so o Stevens-Johnsonovem sindromu (SJS) in toksični epidermalni nekrolizi (TEN), vključno s smrtnimi primeri (glejte poglavje 4.8).
Pharmacokinetic data indicate that clofarabine may accumulate in patients with decreased creatinine clearance (see section 5.2). 
Farmakokinetični podatki kažejo, da se lahko klofarabin kopiči pri bolnikih z zmanjšanim kreatininskim očistkom (glejte poglavje 5.2).
Dose reduction for patients experiencing haematological toxicities 
Zmanjšanje odmerka pri bolnikih, pri katerih se pojavijo hematološki toksični učinki
There are currently insufficient data to establish the safety and efficacy of clofarabine in adult patients. 
Trenutno ni na voljo dovolj podatkov, da bi ocenili varnost in učinkovitost klofarabina pri odraslih bolnikih.
Very common: Anxiety Common: Agitation, restlessness, mental status change 
Pogosti: agitacija, nemirnost, spremembe mentalnega stanja
Type I glass vial with grey chlorobutyl fluoropolymer coated rubber stopper, polypropylene flip-off cap and aluminium overseal. 
Viala iz stekla tipa I z zamaškom iz sive gume, prevlečene s klorobutilnim fluoropolimerom, polipropilensko dvižno zaporko in aluminijastim tesnilom.
However, as clofarabine is not detectably metabolised by the cytochrome P450 (CYP) enzyme system, pathways of non-renal elimination currently remain unknown. 
Klofarabin se ne presnavlja z encimskim sistemom citokrom P450 (CYP) v količini, ki bi jo bilo mogoče zaznati, pot neledvičnega izločanja trenutno ostaja neznana.
However, the pharmacokinetics of clofarabine in adults with relapsed or refractory AML following administration of a single dose of 40 mg/m2 clofarabine by intravenous infusion over 1 hour were comparable to those described above in patients aged between 2 to 19 years old with relapsed or refractory ALL or AML following administration of 52 mg/m2 clofarabine by intravenous infusion over 2 hours for 5 consecutive days. 
Farmakokinetika pri odraslih bolnikih s ponovljeno ali neodzivno AML po intravenskem infundiranju enkratnega odmerka klofarabina 40 mg/m2 v 1 uri je bila primerljiva z zgoraj opisano farmakokinetiko pri bolnikih, starih od 2 do 19 let, s ponovljeno ali neodzivno ALL ali AML po intravenskem infundiranju 52 mg klofarabina/m2 v 2 urah 5 dni zaporedoma.
Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. 
Zdravljenje akutne limfoblastne levkemije (ALL) pri pediatričnih bolnikih, pri katerih se bolezen po vsaj dveh režimih zdravljenja ponovi ali je neodzivna, kadar pri nobeni drugi obliki zdravljenja ne pričakujemo trajnega odziva.
It is supplied in 20 ml glass vials. 
Na voljo je v 20 ml steklenih vialah.
However, possible symptoms of overdose are expected to include nausea, vomiting, diarrhoea and severe bone marrow suppression. 
Med možnimi simptomi prevelikega odmerjanja so navzea, bruhanje, diareja in huda supresija kostnega mozga.
Four renal adverse reactions in 115 patients were considered to be related to clofarabine, none of which were serious; haematuria (3 events) and acute renal failure (1 event) (see sections 4.3 and 4.4). 
Za štiri neželene učinke izmed 115 bolnikov so menili, da so povezani z uporabo klofarabina, med njimi nobeden ni bil resen: hematurija (3 dogodki) in akutna ledvična odpoved (1 dogodek) (glejte poglavji 4.3 in 4.4).
It is then recommended that clofarabine be administered at a further 25% dose reduction. 
Potem se priporoča nadaljevanje zdravljenja z odmerkom, zmanjšanim za dodatnih 25 %.
What Ivozall looks like and contents of the pack Ivozall is a concentrate for solution for infusion. 
Izgled zdravila Ivozall in vsebina pakiranja Zdravilo Ivozall je koncentrat za raztopino za infundiranje.
Nephrotoxic medicinal products, tumour lysis, and tumour lysis with hyperuricemia may contribute to renal toxicity (see sections 4.3 and 4.4). 
Nefrotoksična zdravila, tumorska liza in tumorska liza s hiperurikemijo lahko prispevajo k ledvični toksičnosti (glejte poglavji 4.3 in 4.4).
Six events were considered to be related to clofarabine of which acute cholecystitis (1 event), cholelithiasis (1 event), hepatocellular damage (1 event; patient died (see above)) and hyperbilirubinaemia (1 event; the patient discontinued therapy (see above)) were considered to be serious. 
Za šest dogodkov so menili, da so povezani z uporabo klofarabina, med njimi so akutni holecistitis (1 dogodek), holelitiazo (1 dogodek), okvare jetrnih celic (1 dogodek; bolnik je umrl (glejte zgoraj)) in hiperbilirubinemijo (1 dogodek; bolnik je prekinil zdravljenje (glejte zgoraj)) ocenili kot resne.
The safety profile of clofarabine has not been established in patients with severe renal insufficiency or patients receiving renal replacement therapy (see section 4.3). 
Varnostni profil klofarabina pri bolnikih s hudo insuficienco ledvic oziroma pri bolnikih, ki prejemajo ledvično nadomestno terapijo, ni bil določen (glejte poglavje 4.3).
Common: Pericardial effusion*, tachycardia* 
Pogosti: perikardni izliv*, tahikardija*
Musculoskeletal, connective tissue and bone disorders 
Bolezni mišično-skeletnega sistema, vezivnega tkiva in kosti
- little or no urine, drowsiness, nausea, vomiting, breathlessness, loss of appetite and /or weakness (possible signs of acute kidney failure or kidney failure). 
- če odvajate malo ali nič urina, ali občutite zaspanost, slabost, bruhanje, zasoplost, izgubo apetita in/ali oslabelost (to so lahko znaki akutne odpovedi ledvic/odpovedi ledvic).