natgillin/translations-raw huggingface dataset:
increased risk of death, serious cardiovascular events, and vascular access thrombosis was observed when erythropoiesis-stimulating agents (ESAs) were administered to target a haemoglobin of greater ic
V kliničnih študijah so ugotovili večje tveganje smrti, resnih srčnožilnih dogodkov in tromboze na žilnem dostopu, kadar so eritropoezo stimulirajoče agense (ESA) uporabljali tako, da je bil ciljni hemoglobin nad 120 g/ l (7, 5 mmol/ l). ā ve
epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Kontrolirana klinična preskušanja niso pokazala pomembnih koristi uporabe epoetinov, če koncentracija hemoglobina preseže raven, potrebno za obvladanje simptomov anemije in preprečitev transfuzij krvi. a m
Convulsions have been reported in patients receiving Nespo.
Pri bolnikih, ki so dobivali Nespo, so poročali o konvulzijah. ni
Chronic renal failure patients
Bolniki s kronično odpovedjo ledvic ilo
Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/ l or whose transferrin saturation is below 20%.
Dodatna terapija z železom je priporočljiva pri vseh bolnikih, ki imajo feritin v serumu pod 100 µg/ l ali nasičenost transferina pod 20%. v ra
6 In patients with chronic renal failure and clinical evidence of ischaemic heart disease or congestive heart failure, the target haemoglobin should be determined individually.
Pri takšnih bolnikih naj Zd
In these patients an upper limit of 12 g/ dl (7.5 mmol/ l) should be aimed for, unless severe symptoms (e. g. angina) dictate otherwise.
bi bila ciljna zgornja meja 120 g/ l (7, 5 mmol/ l), razen če hudi simptomi (npr. angina pektoris) ne narekujejo drugače.
ed Effect on tumour growth
Vpliv na rast tumorja
Erythropoietin
Epoetini so rastni dejavniki, ki stimulirajo predvsem nastajanje rdečih krvnih celic.
As with all growth factors,
Eritropoetinski receptorji so lahko izraženi na površini različnih tumorskih celic.
or there is a concern that epoetins could stimulate the growth of tumours.
Tako kot pri vseh rastnih dejavnikih tudi pri epoetinih obstaja skrb, da bi lahko spodbudili rast tumorjev.
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression
V več kontroliranih kliničnih študijah pri bolnikih, ki so imeli anemijo zaradi raka, epoetini niso izboljšali celotnega preživetja in tudi niso zmanjšali tveganja za napredovanje tumorja.
th in patients with anaemia associated with cancer.
et V kontroliranih kliničnih študijah je uporaba Nespa in drugih eritropoezo stimulirajočih agensov (ESA):
au In controlled clinical studies, use of Nespo and other erythropoiesis-stimulating agents (ESAs) have shown:
m • skrajšala čas do napredovanja tumorja pri bolnikih z napredovalim rakom glave in vratu,
• er shortened time to tumour progression in patients with advanced head and neck cancer receiving ng radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l), ESAs are not indicated for use in this patient population. lo
o zdravljenih z obsevanjem, če je bila ciljna vrednost hemoglobina več kot 140 g/ l (8, 7 mmol/ l).
• shortened overall survival and increased deaths attributed to disease progression at 4 months in no
pr Uporaba ESA v tej populaciji bolnikov ni indicirana.
patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5-8.7 mmol/ l) ct
• skrajšala celotno preživetje in povečala število smrti, ki jih je bilo mogoče pripisati napredovanju
• increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in patients with active malignant disease receiving neither chemotherapy nor radiation du
za bolezni po 4 mesecih, pri bolnicah z metastatskim rakom dojke, zdravljenih s kemoterapijo, če je bila ciljna vrednost hemoglobina od 120 do 140 g/ l (od 7, 5 do 8, 7 mmol/ l).
therapy. ESAs are not indicated for use in this patient population. ro
a • povečala tveganje smrti pri bolnikih z aktivno maligno boleznijo, ki niso dobivali ne kemoterapije
In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer.
nj ne obsevanja, če je bila ciljna vrednost hemoglobina 120 g/ l (7, 5 mmol/ l).
Factors that should be considered a
ESA v tej populaciji bolnikov niso indicirani. lje Glede na zgoraj navedeno, je treba v nekaterih kliničnih primerih anemijo pri bolnikih z rakom vo prednostno zdraviti s transfuzijo krvi.
in this assessment should include the type of tumour and its stage; the degree of anaemia; life- in
Odločitev za uporabo rekombinantnih eritropoetinov mora temeljiti na oceni koristi in tveganja in mora biti sprejeta v sodelovanju z bolnikom, upoštevaje do
expectancy; the environment in which the patient is being treated; and patient preference (see section ic
Med dejavniki, ki jih je treba upoštevati pri takšni oceni, so vrsta in stadij tumorja, stopnja anemije, pričakovana življenjska doba, okolje, v katerem poteka bolnikovo zdravljenje in bolnikove želje (glejte poglavje 5. 1). ā
In patients with solid tumours or lymphoproliferative malignancies, if the haemoglobin value exceeds 12 g/ dl (7.5 mmol/ l), the dosage adaptation described in section 4.2 should be closely respected, in M
Če hemoglobin pri bolnikih s čvrstimi tumorji ali limfoproliferativnimi malignomi preseže 120 g/ l (7, 5 ve
order to minimise the potential risk of thromboembolic events.
mmol/ l), natančno upoštevajte prilagoditev odmerka, opisano v poglavju 4. 2, da boste zmanjšali morebitno tveganje za trombembolične incidente.
Platelet counts and haemoglobin level should also be monitored at regular intervals.
V rednih presledkih je treba kontrolirati tudi število trombocitov in koncentracijo hemoglobina. a m
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij ni
However, there is potential for an interaction with drugs that are highly bound to red blood cells e. g. cyclosporin, tacrolimus.
Obstaja pa možnost za interakcije z zdravili, ki so v veliki meri vezana na rdeče krvne celice, npr. s ciklosporinom ilo
If darbepoetin alfa is given concomitantly with any of these drugs, blood levels of these drugs should be monitored and the dosage adjusted as the haemoglobin rises.
Če darbepoetin alfa dajete sočasno s temi zdravili, je treba njihovo koncentracijo v krvi kontrolirati in odmerke prilagajati, ko se koncentracija hemoglobina zvišuje. v ra
7 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje Zd
ed 4.7 Effects on ability to drive and use machines
7 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
is or 4.8 Undesirable effects
4. 8 Neželeni učinki
th General
Splošno
au There have been reports of serious allergic reactions including anaphylactic reaction, angioedema, dyspnoea, skin rash and urticaria associated with darbepoetin alfa.
V povezavi z darbepoetinom alfa so bile opisane resne alergijske reakcije, vključno z anafilaktično reakcijo, angioedemom, dispnejo, izpuščajem po koži in urtikarijo.
Clinical Trial Experience er ng Chronic renal failure patients lo
et Izkušnje iz kliničnih preskušanj
Data presented from controlled studies included 1357 patients, 766 who received Nespo and 591 no
m Bolniki s kronično odpovedjo ledvic
patients who received r-HuEPO.
766 jih je dobivalo Nespo, in 591 r- HuEPO.
In the Nespo group, 83% were receiving dialysis and 17% were not receiving dialysis. ct
V skupini, ki je dobivala Nespo, je bilo 83% bolnikov na dializi, 17% pa ne.
Injection site pain was reported as attributable to treatment in studies where Nespo was administered via subcutaneous injection.
za V študijah, v katerih so Nespo uporabljali subkutano, so kot z zdravljenjem povezani učinek opisovali bolečino na mestu injiciranja.
discomfort was generally mild and transient in nature and occurred predominantly after the first injection. ro
Nelagodje na mestu injiciranja je bilo praviloma blago in prehodno ter se je pojavilo predvsem po prvi injekciji.
Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical lp
a nj Pogostnosti neželenih učinkov, ki veljajo za povezane z Nespom in so jih zabeležili v kontroliranih kliničnih študijah, so: lje Organski sistem o MedDRA
studies are: a
Pogostnost
MedDRA system organ class in
vo
Subject Incidence
Neželena reakcija na zdravilo
Adverse Drug Reaction
srčne bolezni bolezni kože in podkožja
Cardiac Disorders ic
zelo pogosti
Hypertension
hipertenzija izpuščaj/ eritem
Common (≥ 1/ 100 to < 1/ 10)
pogosti (≥ 1/ 100 do < 1/ 10) do
Vascular disorders M
žilne bolezni
General Disorders and Administration Site Conditions
Splošne težave in spremembe na
Injection site pain
mestu aplikacije ve
Adverse reactions were determined based on pooled data from seven randomised, double-blind, placebo-controlled studies of Nespo with a total of 2112 patients (Nespo 1200, placebo 912).
Te m
Patients with solid tumours (e. g., lung, breast, colon, ovarian cancers) and lymphoid malignancies (e. g., lymphoma, multiple myeloma) were enrolled in the clinical studies.
klinične študije so vključile bolnike s čvrstimi tumorji (npr. rakom pljuč, dojke, kolona, jajčnika) in limfatičnimi malignomi (npr. limfomom, multiplim mielomom). ni
8 Incidence of undesirable effects considered related to treatment with Nespo from controlled clinical studies are:
Pogostnost neželenih učinkov, ki veljajo za povezane z Nespom in so jih zabeležili v kontroliranih ilo
MedDRA system organ class Skin and Subcutaneous Tissue Disorders
Organski sistem po MedDRA ra
Subject Incidence Common (≥ 1/ 100 to < 1/ 10)
pogosti (≥ 1/ 100 do < 1/ 10)
Adverse Drug Reaction Rash/ Erythema
izpuščaj/ eritem
Vascular disorders
Žilne bolezni Zd
Thromboembolic events, including pulmonary embolism
trombembolični dogodki,
General Disorders and Administration Site Conditions
vključno s pljučno embolijo Splošne težave in spremembe na mestu aplikacije
Injection site pain
edemi bolečina na mestu injiciranja
ed Postmarketing Experience
Pomarketinške izkušnje
is The following adverse reactions have been identified during postmarketing use of Nespo:
Med pomarketinško uporabo Nespa so ugotovili naslednje neželene učinke:
In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Nespo therapy have been reported predominantly in
• Čisto aplazijo rdečih celic V posameznih primerih je bila v povezavi s terapijo z Nespom opisana čista aplazija rdečih celic zaradi nevtralizirajočih protieritropoetinskih protiteles,
au patients with CRF treated subcutaneously.
8 pretežno pri bolnikih s kronično odpovedjo ledvic, ki so zdravilo dobivali subkutano.
In case PRCA is diagnosed, therapy with Nespo must be discontinued and patients should not be switched to another recombinant erythropoietic protein (see section 4.4).
Če je diagnosticirana čista aplazija rdečih celic, morate terapijo z Nespom prekiniti, bolnika pa ne smete prevesti na drugo rekombinantno eritropoetično beljakovino (glejte poglavje 4. 4).
• er Allergic reactions, including anaphylactic reaction, angioedema, skin rash and urticaria. ng • Convulsions. lo
• Alergijske reakcije, vključno z anafilaktično reakcijo, angioedemom, izpuščajem in urtikarijo.
4.9 Overdose no
• Konvulzije.
The therapeutic margin of Nespo is very wide.
et Terapevtska meja Nespa je zelo široka.
Even at very high serum levels, no symptoms of overdose have been observed. ct du
Celo ob zelo visoki koncentraciji v serumu niso opazili simptomov prevelikega odmerjanja.
In the event of polycythaemia, Nespo should be temporarily withheld (see section 4.2).
Narediti je
If clinically indicated, phlebotomy may be performed. ro lp
o mogoče flebotomijo, če je klinično indicirana.
5.
pr 5.
PHARMACOLOGICAL PROPERTIES a
FARMAKOLOŠKE LASTNOSTI
5.1 Pharmacodynamic properties in
za 5. 1 Farmakodinamične lastnosti
Pharmacotherapeutic group:
a Farmakoterapevtska skupina: druga zdravila za zdravljenje slabokrvnosti.
Human erythropoietin is an endogenous glycoprotein hormone that is the primary regulator of erythropoiesis through specific interaction with the erythropoietin receptor on the erythroid progenitor cells in the bone marrow.
nj Humani eritropoetin je endogen glikoproteinski hormon, ki primarno uravnava eritropoezo, in sicer lje preko specifične interakcije z eritropoetinskim receptorjem na eritroidnih matičnih celicah v kostnem mozgu.
kidney in response to changes in tissue oxygenation.
Eritropoetin nastaja predvsem v ledvicah, ki ga tudi uravnavajo v odziv na spremembe v vo oksigenaciji tkiva.
Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anaemia is due to erythropoietin deficiency.
Pri onkoloških bolnikih, ki do
In patients with cancer receiving chemotherapy the etiology of anaemia is multifactorial.
dobivajo kemoterapijo, je v etiologijo anemije vpletenih več dejavnikov.
In these patients, erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous erythropoietin both contribute significantly towards their anaemia.
Pri teh bolnikih k anemiji bistveno pripomoreta tako pomanjkanje eritropoetina kot slabši odziv eritroidnih matičnih celic na endogeni eritropoetin. ā
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
Darbepoetin alfa ve
Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three.
ima pet N- vezanih ogljikohidratnih verig, endogeni hormon in rekombinantni humani eritropoetini (r- HuEPO) pa imajo tri.
Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater
Zaradi večje vsebnosti ogljikovih hidratov je terminalni razpolovni čas darbepoetina alfa a
9 in vivo activity.
Kljub tem m
Despite these molecular changes, darbepoetin alfa retains a very narrow specificity for the erythropoietin receptor.
molekulskim spremembam darbepoetin alfa ohranja zelo ozko specifičnost za eritropoetinski receptor. ni
Cancer patients receiving chemotherapy
Onkološki bolniki, ki dobivajo kemoterapijo ilo
In a prospective, randomised double-blind, placebo-controlled study conducted in 314 lung cancer patients receiving platinum containing chemotherapy there was a significant reduction in transfusion requirements (p < 0.001).
V prospektivni, randomizirani, dvojno slepi, s placebom kontrolirani študiji pri 314 bolnikih z rakom na pljučih, ki so dobivali kemoterapijo s platino, so ugotovili značilno zmanjšanje potreb po transfuziji (p < 0, 001). v ra
Clinical studies have demonstrated that darbepoetin alfa had similar effectiveness when administered as a single injection either once every three weeks, once every two weeks, or weekly without any increase in total dose requirements.
Klinične študije so pokazale, da je darbepoetin alfa podobno učinkovit, če je uporabljen v posamični injekciji bodisi enkrat na tri tedne, enkrat na dva tedna ali vsak teden, brez potrebe po povečanju Zd
ed The safety and effectiveness of once every three weeks dosing of Nespo therapy in reducing the requirement for red blood cell transfusions in patients undergoing chemotherapy was assessed in a
celotnega odmerka.
is randomised, double-blind, multinational study.
Varnost in učinkovitost zdravljenja z Nespom enkrat na tri tedne za zmanjšanje potrebe po transfuzijah eritrocitov so pri bolnikih na kemoterapiji raziskali v randomizirani, dvojno slepi mednarodni študiji.
This study was conducted in 705 anaemic patients with
Študija je bila narejena pri 705 anemičnih bolnikih z nemieloičnimi malignomi, ki so dobivali več ciklusov kemoterapije.
or non-myeloid malignancies receiving multi-cycle chemotherapy.
Bolnike so randomizirali na prejemanje Nespa 500 µg enkrat na tri tedne ali 2, 25 µg/ kg enkrat na teden.
In both groups, the dose was
V obeh skupinah so odmerek zmanjšali za 40% predhodnega odmerka (npr. prvo zmanjšanje na 300 µg v skupini enkrat na tri tedne in na 1, 35 µg/ kg v skupini enkrat na teden), če se je hemoglobin v 14- dnevnem obdobju zvišal za več kot 10 g/ l.
th reduced by 40% of the previous dose (e. g., for first dose reduction, to 300 μ g in the once every three weeks group and 1.35 μ g / kg in the once weekly group) if haemoglobin increased by more than 1 g/ dl
V skupini enkrat na tri tedne je zmanjšanje odmerka potrebovalo 72% bolnikov, v skupini enkrat na teden pa 75% bolnikov.
This study supports 500 μ g once
9 Študija potrjuje, da je uporaba 500 µg enkrat na tri tedne primerljiva uporabi enkrat na teden, kar zadeva incidenco preiskovancev, ki so od 5. tedna do konca terapevtske faze dobili vsaj eno transfuzijo eritrocitov.
er every three weeks being comparable to once weekly administration with respect to the incidence of subjects receiving at least one red blood cell transfusion from week 5 to the end of treatment phase. ng In a prospective, randomised double-blind, placebo-controlled study conducted in 344 anaemic lo patients with lymphoproliferative malignancies receiving chemotherapy there was a significant reduction in transfusion requirements and an improvement in haemoglobin response (p < 0.001). no
V prospektivni, randomizirani, dvojno slepi s placebom kontrolirani študiji pri 344 anemičnih bolnikih z limfoproliferativnimi malignomi, ki so dobivali kemoterapijo, so ugotovili značilno zmanjšanje potreb po transfuziji in boljši odziv hemoglobina (p < 0, 001).
Improvement in fatigue, as measured by the Functional Assessment of Cancer Therapy-fatigue (FACT-fatigue) scale, was also observed. ct
Ugotovili so tudi izboljšanje utrujenosti, merjene z lestvico FACT- utrujenost (Functional Assessment of Cancer Therapy- fatigue).
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. du
Receptorji za
Survival and tumour progression have been examined in five large controlled studies involving a total ro
et eritropoetin so lahko izraženi na površini različnih tumorskih celic.
of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
m Preživetje bolnikov in napredovanje tumorja so raziskali v petih velikih kontroliranih študijah, ki so skupaj zajele 2833 bolnikov.
The lp
Štiri so bile dvojno slepe, s placebom kontrolirane študije, ena pa je bila
target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
Dve sta zajeli bolnike, zdravljene s kemoterapijo.
In the open-label study there was no difference in overall survival between patients treated a
Ciljna koncentracija hemoglobina v teh dveh
with recombinant human erythropoietin and controls.
pr študijah je bila > 130 g/ l, v preostalih treh pa od 120 do 140 g/ l.
ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
V odprti študiji ni bilo razlike v celotnem preživetju bolnikov, zdravljenih z rekombinantnim humanim eritropoetinom, in bolnikov v kontrolni skupini.
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia ic
V štirih študijah, kontroliranih s placebom, je bilo razmerje ogroženost za celotno
associated with various common cancers who received recombinant human erythropoietin compared ed
Te študije so pokazale dosledno, nepojasnjeno in statistično značilno večjo umrljivost med bolniki z anemijo zaradi različnih pogostih vrst raka, ki so dobivali rekombinantni humani eritropoetin, v primerjavi z bolniki v kontrolnih
to controls.
a skupinah.
Overall survival outcome in the trials could not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human M
Rezultata celotnega preživetja v teh preskušanjih ni mogoče zadovoljivo pojasniti z različno
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
nj incidenco tromboze in sorodnih zapletov med bolniki, ki so dobivali rekombinantni humani eritropoetin, in bolniki v kontrolni skupini. lje Sistematično so pregledali tudi podatke o več kot 9000 bolnikih z rakom, ki so sodelovali v 57 vo kliničnih preskušanjih.
0.99, 1.18; 42 trials and 8167 patients).
0, 99, 1, 18; 42 preskušanj in 8167 bolnikov). do
There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
Obstajajo konsistentni dokazi, da lahko bolnikom z rakom zdravljenje z rekombinantnim humanim ā
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with
Ni pa jasno, v kolikšni meri bi te ugotovitve lahko veljale za uporabo ve
10 chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
rekombinantnega eritropoetina pri bolnikih z rakom, ki dobivajo kemoterapijo, če je ciljna koncentracija hemoglobina manjša od 130 g/ l; analizirani podatki so namreč obsegali le malo bolnikov s takšnimi značilnostmi. a m
5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti ni
Due to its increased carbohydrate content the level of darbepoetin alfa in the circulation remains above the minimum stimulatory concentration for erythropoiesis for longer than the equivalent molar dose of r-HuEPO, allowing darbepoetin alfa to be administered less frequently to achieve the same biological response.
Zaradi večje vsebnosti ogljikovih hidratov ostane koncentracija darbepoetina alfa v obtoku višja od najmanjše stimulacijske koncentracije za eritropoezo dalj časa kot po enakovrednem molarnem ilo
Chronic renal failure patients
Bolniki s kronično odpovedjo ledvic ra
ed The pharmacokinetics of darbepoetin alfa has been studied clinically in chronic renal failure patients following intravenous and subcutaneous administration.
Farmakokinetiko darbepoetina alfa so raziskali pri bolnikih s kronično odpovedjo ledvic po intravenski Zd
Clearance of darbepoetin alfa is 1.9 ml/ hr/ kg
Terminalni razpolovni čas intravensko apliciranega darbepoetina alfa je 21 ur (standardni odklon 7, 5).
is (SD 0.56) and the volume of distribution (Vss) is approximately equal to plasma volume (50 ml/ kg).
Očistek darbepoetina alfa je 1, 9 ml/ h/ kg (standardni odklon 0, 56), volumen porazdelitve (Vss) pa je približno enak volumnu plazme (50 ml/ kg).
or Bioavailability is 37% with subcutaneous administration.
Biološka uporabnost po subkutani uporabi je 37%.
In clinical studies, minimal
Po uporabi darbepoetina alfa enkrat na mesec v subkutanih odmerkih od 0, 6 do 2, 1 μg/ kg je bil terminalni razpolovni čas 73 ur (standardni odklon 24).
au accumulation was observed with either route of administration.
V kliničnih študijah so pri obeh načinih uporabe opažali minimalno kopičenje.
er Data from 809 patients receiving Nespo in European clinical studies were analysed to assess the dose ng required to maintain haemoglobin; no difference was observed between the average weekly dose administered via the intravenous or subcutaneous routes of injection. lo
10 Za določitev odmerka, potrebnega za vzdrževanje hemoglobina, so analizirali 809 bolnikov, ki so Nespo dobivali v evropskih kliničnih študijah; med povprečnim tedenskim odmerkom, uporabljenim intravensko ali subkutano, niso ugotovili razlik.
Compared with pharmacokinetic data from adults with CRF where the same sampling duration was used, the ct
S proučevanjem farmakokinetike darbepoetina alfa pri pediatričnih bolnikih (starih od 3 do 16 let) s kronično boleznijo ledvic, ki so bili ali niso bili na dializi, so določili farmakokinetične profile za obdobja vzorčenja do 1 tedna (168 ur) po enem samem subkutanem ali intravenskem odmerku.