natgillin/translations-raw huggingface dataset:
Treatment with Aranesp should be temporarily discontinued if haemoglobin levels exceed 13 g/ dl (8.1 mmol/ l).
Če koncentracija hemoglobina preseže 130 g/ l (8, 1 mmol/ l), morate uporabo Aranespa začasno prekiniti.
Therapy should be reinitiated at approximately 25% lower than the previous dose after haemoglobin levels fall to 12 g/ dl (7.5 mmol/ l) or below.
Potem, ko se hemoglobin zniža na 120 g/ l (7, 5 mmol/ l) ali manj, je treba terapijo znova uvesti z odmerkom, približno 25% manjšim od prejšnjega.
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in 4 weeks, the dose should be reduced by 25 to 50%.
Če se koncentracija hemoglobina v 4 tednih zviša za več kot 20 g/ l (1, 25 mmol/ l), je odmerek treba zmanjšati za 25 do 50%.
Hypersensitivity to darbepoetin alfa, r-HuEPO or any of the excipients.
Preobčutljivost za darbepoetin alfa, r- HuEPO ali katerokoli pomožno snov.
5 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
Blood pressure should be monitored in all patients, particularly during initiation of Aranesp therapy.
Vsem bolnikom morate kontrolirati krvni tlak, zlasti med začetkom zdravljenja z Aranespom.
If blood pressure is difficult to control by initiation of appropriate measures, the haemoglobin may be reduced by decreasing or withholding the dose of Aranesp (see section 4.2).
Če je krvni tlak po uvedbi ustreznih ukrepov težko obvladovati, lahko hemoglobin znižate z zmanjšanjem ali zadržanjem odmerka Aranespa (glejte poglavje 4. 2).
Non-response to therapy with Aranesp should prompt a search for causative factors.
5 Če se bolnik na terapijo z Aranespom ne odzove, je treba raziskati vzročne dejavnike za to.
These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to darbepoetin alfa (see section 4.8).
Ugotovljeno je, da ta protitelesa navzkrižno reagirajo z vsemi eritropoetičnimi beljakovinami; bolnikov, pri katerih obstaja sum ali pri katerih je potrjeno, da imajo nevtralizirajoča protitelesa proti eritropoetinu, ne smete prevesti na darbepoetin alfa (glejte poglavje 4. 8).
Active liver disease was an exclusion criteria in all studies of Aranesp, therefore no data are available from patients with impaired liver function.
Aktivna bolezen jeter je bila v vseh študijah Aranespa merilo za nevključitev, zato o bolnikih z okvarjenim delovanjem jeter ni podatkov.
Since the liver is thought to be the principal route of elimination of Aranesp and r-HuEPO, Aranesp should be used with caution in patients with liver disease.
Vendar jetra veljajo za glavno pot eliminacije Aranespa in r- HuEPO, zato morate Aranesp pri bolnikih z boleznimi jeter uporabljati previdno.
Aranesp should also be used with caution in those patients with sickle cell anaemia or epilepsy.
Prav tako morate Aranesp uporabljati previdno pri bolnikih z anemijo srpastih celic ali epilepsijo.
Misuse of Aranesp by healthy persons may lead to an excessive increase in packed cell volume.
Zloraba Aranespa pri zdravih osebah lahko povzroči čezmerno zvečanje hematokrita.
This may be associated with life-threatening complications of the cardiovascular system.
To je lahko povezano s smrtno nevarnimi zapleti na srčno- žilnem sistemu.
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
Pri bolnikih s kronično odpovedjo ledvic vzdrževana koncentracija hemoglobina ne sme preseči zgornje meje ciljne koncentracije, priporočene v poglavju 4. 2.
In clinical studies, an 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 than 12 g/ dl (7.5 mmol/ l).
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).
Aranesp should be used with caution in patients with epilepsy.
Pri bolnikih z epilepsijo morate Aranesp uporabljati previdno.
Convulsions have been reported in patients receiving Aranesp.
Pri bolnikih, ki so dobivali Aranesp, so poročali o konvulzijah.
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%.
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 bolnikih s kronično odpovedjo ledvic in kliničnimi znaki ishemične bolezni srca ali kongestivnega srčnega popuščanja je treba ciljno vrednost hemoglobina določiti posamezno.
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.
Pri takšnih bolnikih naj bi bila ciljna zgornja meja 120 g/ l (7, 5 mmol/ l), razen če hudi simptomi (npr. angina pektoris) ne narekujejo drugače.
Serum potassium levels should be monitored regularly during Aranesp therapy.
Med zdravljenjem z Aranespom je treba redno kontrolirati koncentracijo kalija v serumu.
Potassium elevation has been reported in a few patients receiving Aranesp, though causality has not been established.
Pri nekaj bolnikih, ki so dobivali Aranesp, so zabeležili zvišanje kalija, vendar vzročne povezanosti niso ugotovili.
If an elevated or rising potassium level is observed then consideration should be given to ceasing Aranesp administration until the level has been corrected.
Če se izkaže, da je kalij zvišan ali se zvišuje, pride v poštev prenehanje uporabe Aranespa, dokler se koncentracija kalija ne uredi.
Cancer patients
6 Onkološki bolniki
In controlled clinical studies, use of Aranesp and other erythropoiesis-stimulating agents (ESAs) have shown:
V kontroliranih kliničnih študijah je uporaba Aranespa in drugih eritropoezo stimulirajočih agensov (ESA):
• shortened time to tumour progression in patients with advanced head and neck cancer receiving 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.
Uporaba ESA v tej populaciji bolnikov ni indicirana.
• shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5-8.7 mmol/ l)
• skrajšala celotno preživetje in povečala število smrti, ki jih je bilo mogoče pripisati napredovanju 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).
• 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 therapy. ESAs are not indicated for use in this patient population.
ESA v tej populaciji bolnikov niso indicirani.
Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life- expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1).
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).
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 order to minimise the potential risk of thromboembolic events.
Če hemoglobin pri bolnikih s čvrstimi tumorji ali limfoproliferativnimi malignomi preseže 120 g/ l (7, 5 mmol/ l), natančno upoštevajte prilagoditev odmerka, opisano v poglavju 4. 2, da boste zmanjšali morebitno tveganje za trombembolične incidente.
The clinical results obtained so far do not indicate any interaction of Aranesp with other substances.
Dosedanji klinični rezultati ne kažejo, da bi Aranesp medsebojno deloval z drugimi snovmi.
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 ali takrolimusom.
7 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
For Aranesp no clinical data on exposed pregnancies are available.
Za Aranesp ni na voljo kliničnih podatkov o uporabi pri nosečnicah.
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
Študije na živalih niso pokazale neposrednih škodljivih vplivov na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj.
As there is no clinical experience with lactating women Aranesp should not be administered to women who are breast-feeding.
Kliničnih izkušenj z Aranespom pri doječih ženskah ni, zato ga pri takšnih ženskah ne smete uporabljati.
When Aranesp therapy is absolutely indicated women must stop breast- feeding.
Če je Aranesp absolutno indiciran, mora ženska nehati dojiti.
4.7 Effects on ability to drive and use machines
7 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
There have been no observed effects with Aranesp on the ability to drive and use machines.
Ni ugotovljeno, da bi Aranesp vplival na sposobnost vožnje in upravljanja s stroji.
Data presented from controlled studies included 1357 patients, 766 who received Aranesp and 591 patients who received r-HuEPO.
766 jih je dobivalo Aranesp in 591 r- HuEPO.
In the Aranesp group, 83% were receiving dialysis and 17% were not receiving dialysis.
V skupini, ki je dobivala Aranesp, je bilo 83% bolnikov na dializi, 17% pa ne.
Injection site pain was reported as attributable to treatment in studies where Aranesp was administered via subcutaneous injection.
V študijah, v katerih so Aranesp uporabljali subkutano, so kot z zdravljenjem povezani učinek opisovali bolečino na mestu injiciranja.
This was seen more frequently than with r-HuEPO.
To je bilo zabeleženo pogosteje kot pri r- HuEPO.
Incidence of undesirable effects considered related to treatment with Aranesp from controlled clinical studies are:
Pogostnosti neželenih učinkov, ki veljajo za povezane z Aranespom in so jih zabeležili v kontroliranih kliničnih študijah, so:
MedDRA system organ class Cardiac Disorders Skin and Subcutaneous Tissue Disorders
Organski sistem po MedDRA Srčne bolezni
Subject Incidence Very Common (≥ 1/ 10) Common (≥ 1/ 100 to < 1/ 10)
Pogostnost zelo pogosti (≥ 1/ 10)
Adverse Drug Reaction Hypertension Rash/ Erythema
Neželeni učinek hipertenzija
Uncommon (≥ 1/ 1,000 to < 1/ 100)
občasni (≥ 1/ 1. 000 do < 1/ 100)
Thromboembolic Events
trombembolični dogodki
Common (≥ 1/ 100 to < 1/ 10)
pogosti (≥ 1/ 100 do < 1/ 10)
Adverse reactions were determined based on pooled data from seven randomised, double-blind, placebo-controlled studies of Aranesp with a total of 2112 patients (Aranesp 1200, placebo 912).
Neželene učinke so ugotavljali na podlagi kumulativnih podatkov sedmih randomiziranih, dvojno slepih, s placebom kontroliranih študij Aranespa pri skupaj 2112 bolnikih (Aranesp 1200, placebo 912).
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.
Te klinične študije so vključile bolnike s čvrstimi tumorji (npr. rakom pljuč, dojke, kolona, jajčnika) in limfatičnimi malignomi (npr. limfomom, multiplim mielomom).
8 Incidence of undesirable effects considered related to treatment with Aranesp from controlled clinical studies are:
Pogostnost neželenih učinkov, ki veljajo za povezane z Aranespom in so jih zabeležili v kontroliranih kliničnih študijah, so:
MedDRA system organ class Skin and Subcutaneous Tissue Disorders
Organski sistem po MedDRA Bolezni kože in podkožja
Subject Incidence Common (≥ 1/ 100 to < 1/ 10)
Pogostnost pogosti (≥ 1/ 100 do < 1/ 10)
Adverse Drug Reaction Rash/ Erythema
Neželeni učinek izpuščaj/ eritem
Very Common (≥ 1/ 10)
zelo pogosti (≥ 1/ 10) pogosti (≥ 1/ 100 do < 1/ 10)
Common (≥ 1/ 100 to < 1/ 10)
edemi bolečina na mestu injiciranja
Injection site pain
Pomarketinške izkušnje
Postmarketing Experience
Med pomarketinško uporabo Aranespa so ugotovili naslednje neželene učinke:
The following adverse reactions have been identified during postmarketing use of Aranesp:
• Čisto aplazijo rdečih celic V posameznih primerih je bila v povezavi s terapijo z Aranespom opisana čista aplazija rdečih celic zaradi nevtralizirajočih protieritropoetinskih protiteles,
In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Aranesp therapy have been reported predominantly in 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 Aranesp 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 Aranespom prekiniti, bolnika pa ne smete prevesti na drugo rekombinantno eritropoetično beljakovino (glejte poglavje 4. 4).
The therapeutic margin of Aranesp is very wide.
Terapevtska meja Aranespa je zelo široka.
In the event of polycythaemia, Aranesp should be temporarily withheld (see section 4.2).
V primeru policitemije je treba uporabo Aranespa prehodno prekiniti (glejte poglavje 4. 2).
Pharmacotherapeutic group:
Farmakoterapevtska skupina: druga zdravila za zdravljenje slabokrvnosti.
Anti-anaemic ATC Code:
Oznaka ATC:
Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three.
Darbepoetin alfa 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 daljši kot terminalni razpolovni čas r- HuEPO, zato je njegova aktivnost in vivo večja.
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).
The safety and effectiveness of once every three weeks dosing of Aranesp therapy in reducing the requirement for red blood cell transfusions in patients undergoing chemotherapy was assessed in a randomised, double-blind, multinational study.
Varnost in učinkovitost zdravljenja z Aranespom enkrat na tri tedne za zmanjšanje potrebe po transfuzijah eritrocitov so pri bolnikih na kemoterapiji raziskali v randomizirani, dvojno slepi mednarodni študiji.
Patients were randomized to receive Aranesp at 500 μ g once every three weeks or 2.25 μ g / kg once weekly.
Bolnike so randomizirali na prejemanje Aranespa 500 µg enkrat na tri tedne ali 2, 25 µg/ kg enkrat na teden.
In both groups, the dose was 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 in a 14-day period.
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.
In the once every three weeks group, 72% of patients required dose reductions.
V skupini enkrat na tri tedne je zmanjšanje odmerka potrebovalo 72% bolnikov, v skupini enkrat na
In the once weekly group, 75% of patients required dose reductions.
9 teden pa 75% bolnikov.
This study supports 500 μ g once 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.
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.
In a prospective, randomised double-blind, placebo-controlled study conducted in 344 anaemic patients with lymphoproliferative malignancies receiving chemotherapy there was a significant reduction in transfusion requirements and an improvement in haemoglobin response (p < 0.001).
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.
Ugotovili so tudi izboljšanje utrujenosti, merjene z lestvico FACT- utrujenost (Functional Assessment of Cancer Therapy- fatigue).
Survival and tumour progression have been examined in five large controlled studies involving a total of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
Preživetje bolnikov in napredovanje tumorja so raziskali v petih velikih kontroliranih študijah, ki so skupaj zajele 2833 bolnikov.
Two of the studies recruited patients who were being treated with chemotherapy.
Štiri so bile dvojno slepe, s placebom kontrolirane študije, ena pa je bila odprta.
The target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
Ciljna koncentracija hemoglobina v teh dveh študijah je bila > 130 g/ l, v preostalih treh pa od 120 do 140 g/ l.
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
V štirih študijah, kontroliranih s placebom, je bilo razmerje ogroženost za celotno preživetje med 1, 25 in 2, 47 v korist bolnikov v kontrolnih skupinah.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
Ocena ogroženosti na podlagi metaanalize podatkov o celotnem preživetju je bila 1, 08 v korist kontrolne skupine (95% IZ:
0.99, 1.18; 42 trials and 8167 patients).
0, 99, 1, 18; 42 preskušanj in 8167 bolnikov).
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
Pri bolnikih, zdravljenih z rekombinantnim humanim eritropoetinom, so ugotovili večje relativno tveganje za trombembolične dogodke (RT 1, 67, 95% IZ:
1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
1, 35, 2, 06; 35 preskušanj in 6769 bolnikov).
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with
Obstajajo konsistentni dokazi, da lahko bolnikom z rakom zdravljenje z rekombinantnim humanim eritropoetinom škoduje.
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.
Ni pa jasno, v kolikšni meri bi te ugotovitve lahko veljale za uporabo 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.
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 odmerku r- HuEPO; tako je mogoče z manj pogosto uporabo darbepoetina alfa doseči enak biološki odziv.
The terminal half-life of darbepoetin alfa is 21 hours (SD 7.5) when administered intravenously.
Terminalni razpolovni čas intravensko apliciranega darbepoetina alfa je 21 ur (standardni odklon 7, 5).
Clearance of darbepoetin alfa is 1.9 ml/ hr/ kg (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).
Bioavailability is 37% with subcutaneous administration.
Biološka uporabnost po subkutani uporabi je 37%.
Following monthly administration of darbepoetin alfa, at subcutaneous doses ranging from 0.6 to 2.1 µg/ kg, the terminal half-life was 73 hours (SD 24).
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).
Data from 809 patients receiving Aranesp in European clinical studies were analysed to assess the dose required to maintain haemoglobin; no difference was observed between the average weekly dose administered via the intravenous or subcutaneous routes of injection.
10 Za določitev odmerka, potrebnega za vzdrževanje hemoglobina, so analizirali 809 bolnikov, ki so Aranesp dobivali v evropskih kliničnih študijah; med povprečnim tedenskim odmerkom, uporabljenim intravensko ali subkutano, niso ugotovili razlik.
Following intravenous administration, an approximate 25% difference between paediatric and adult patients in the area under the curve from time 0 to infinity (AUC[0-∞]) was observed; however, this difference was less than the 2-fold range in AUC(0-∞) observed for the pediatricpatients.
Po intravenski uporabi so med pediatričnimi in odraslimi bolniki ugotovili približno 25% razliko v površini pod krivuljo od časa 0 do neskončnosti (AUC( 0– ∞)); vendar je bila ta razlika manjša od 2- kratnega razpona AUC( 0– ∞), ugotovljenega pri pediatričnih bolnikih.
AUC(0-∞) was similar between adult and paediatric patients with CRF following subcutaneous administration.
AUC( 0– ∞) po subkutani uporabi je bila pri odraslih in pediatričnih bolnikih s kronično boleznijo ledvic podobna.
Following subcutaneous administration of 2.25 µg/ kg to adult cancer patients a mean peak concentration of 10.6 ng/ ml (SD 5.9) of darbepoetin alfa was reached at a mean time of 91 hours (SD 19.7).
Pri odraslih onkoloških bolnikih je darbepoetin alfa po subkutani uporabi 2, 25 µg/ kg dosegel povprečno največjo koncentracijo 10, 6 ng/ ml (standardni odklon 5, 9) v povprečno 91 urah (standardni odklon 19, 7).
These parameters were consistent with dose linear pharmacokinetics over a wide dose range (0.5 to 8 µg/ kg weekly and 3 to 9 µg/ kg every two weeks).
Ti parametri se skladajo s farmakokinetiko, linearno povezano z odmerkom, v širokem odmernem območju (od 0, 5 do 8 µg/ kg na teden in od 3 do 9 µg/ kg na dva tedna).
There was an expected moderate (< 2 fold) increase in serum concentration as steady state was approached, but no unexpected accumulation upon repeated administration.
Ko se je bližalo stanje dinamičnega ravnovesja, je prišlo do pričakovanega zmernega (< 2- kratnega) povečanja koncentracije v serumu, ni pa bilo med ponavljajočo uporabo nobenega nepričakovanega kopičenja.