natgillin/translations-raw huggingface dataset:
or th • Pure Red Cell Aplasia.
• Čisto aplazijo rdečih celic.
In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Nespo therapy have been reported predominantly in
V posameznih primerih je bila v povezavi s terapijo z Nespom opisana čista aplazija rdečih celic zaradi nevtralizirajočih protieritropoetinskih protiteles, 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 Nespoom prekiniti, bolnika pa ne smete prevesti na drugo rekombinantno eritropoetično beljakovino (glejte poglavje 4. 4).
4.9 Overdose no
et • Konvulzije.
The therapeutic margin of Nespo is very wide.
o Terapevtska meja Nespa je zelo široka.
Even at very high serum levels, no symptoms of overdose have been observed. ct du
pr simptomov prevelikega odmerjanja.
If clinically indicated, phlebotomy may be performed. ro lp
za mogoče flebotomijo, če je klinično indicirana.
5.
a 5.
5.1 Pharmacodynamic properties in
nj 5. 1 Farmakodinamične lastnosti lje Farmakoterapevtska skupina: druga zdravila za zdravljenje slabokrvnosti.
B03XA02. ic ed
B03XA02. vo
The production of erythropoietin primarily occurs in and is regulated by the M
Humani eritropoetin je endogen glikoproteinski hormon, ki primarno uravnava eritropoezo, in sicer do
kidney in response to changes in tissue oxygenation.
Eritropoetin nastaja predvsem v ledvicah, ki ga tudi uravnavajo v odziv na spremembe v oksigenaciji tkiva.
In patients with cancer receiving chemotherapy the etiology of anaemia is multifactorial.
Pri onkoloških bolnikih, ki ā
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 ve
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
bistveno pripomoreta tako pomanjkanje eritropoetina kot slabši odziv eritroidnih matičnih celic na endogeni eritropoetin. a
Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three.
Darbepoetin alfa m
The additional sugar residues are molecularly indistinct from those on the endogenous hormone.
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
Dodatne sladkorne skupine se molekulsko ne ločijo od tistih na endogenem ni
21 in vivo activity.
hormonu.
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. v
Cancer patients receiving chemotherapy
Onkološki bolniki, ki dobivajo kemoterapijo ra
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 Zd
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.
(p < 0, 001).
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
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 celotnega odmerka.
or non-myeloid malignancies receiving multi-cycle chemotherapy.
Bolnike so randomizirali na prejemanje Nespa 500 µg enkrat na tri tedne ali
Patients were randomized to receive Nespo at 500 μ g once every three weeks or 2.25 μ g / kg once weekly.
21 2, 25 µg/ kg enkrat na teden.
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 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 teden pa 75% bolnikov.
This study supports 500 μ g once
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
Erythropoetin is a growth factor that primarily stimulates red blood cell production.
m Eritropoetini so rastni dejavniki, ki spodbujajo predvsem nastajanje rdečih krvnih celic.
Survival and tumour progression have been examined in five large controlled studies involving a total ro
o 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.
pr Preživetje bolnikov in napredovanje tumorja so raziskali v petih velikih kontroliranih študijah, ki so skupaj zajele 2833 bolnikov.
In the open-label study there was no difference in overall survival between patients treated a
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 in
V odprti študiji ni bilo razlike v celotnem preživetju bolnikov, zdravljenih z rekombinantnim humanim eritropoetinom, in bolnikov v
ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
a kontrolni skupini.
associated with various common cancers who received recombinant human erythropoietin compared ed
nj preživetje med 1, 25 in 2, 47 v korist bolnikov v kontrolnih 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
Te študije so pokazale dosledno, nepojasnjeno in statistično značilno večjo umrljivost med bolniki z anemijo zaradi različnih pogostih lje vrst raka, ki so dobivali rekombinantni humani eritropoetin, v primerjavi z bolniki v kontrolnih skupinah.
erythropoietin and those in the control group.
Rezultata celotnega preživetja v teh preskušanjih ni mogoče zadovoljivo pojasniti z različno vo incidenco tromboze in sorodnih zapletov med bolniki, ki so dobivali rekombinantni humani eritropoetin, in bolniki v kontrolni skupini. do
0.99, 1.18; 42 trials and 8167 patients).
0, 99, 1, 18; 42 preskušanj in 8167 bolnikov). ā ve
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 a
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 m
22 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 ni
5.2 Pharmacokinetic properties
s takšnimi značilnostmi. ilo
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.
Zd
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 in subkutani uporabi.
The longer terminal half-life of darbepoetin alfa administered subcutaneously compared to intravenously is due to subcutaneous absorption kinetics.
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).
In clinical studies, minimal
V kliničnih študijah so pri obeh
au accumulation was observed with either route of administration.
22 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
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.
Assessment of the pharmacokinetics of darbepoetin alfa in paediatric patients (3 to 16 years) with CRF no
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.
Compared with pharmacokinetic data from adults with CRF where the same sampling duration was used, the ct
et Primerjava s farmakokinetičnimi podatki odraslih bolnikov s kronično boleznijo ledvic, pri katerih je vzorčenje trajalo enako dolgo, je pokazala, da je farmakokinetika darbepoetina alfa pri pediatričnih in
comparison showed that the pharmacokinetics of darbepoetin alfa were similar for paediatric and adult patients with CRF.
m odraslih bolnikih s kronično boleznijo ledvic podobna.
Following intravenous administration, an approximate 25% difference between du
Po intravenski uporabi so med pediatričnimi in odraslimi bolniki ugotovili približno 25% razliko v površini pod krivuljo od časa 0 do neskončnosti
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 ro
o (AUC( 0– ∞)); vendar je bila ta razlika manjša od 2- kratnega razpona AUC( 0– ∞), ugotovljenega pri
pediatricpatients.
pr pediatričnih bolnikih.
CRF following both intravenous and subcutaneous administration. a
Tudi razpolovni čas je bil pri odraslih in pediatričnih bolnikih s kronično boleznijo ledvic podoben, tako po intravenski kot po subkutani uporabi.
Cancer patients receiving chemotherapy in
za Onkološki bolniki, ki dobivajo kemoterapijo
Following subcutaneous administration of 2.25 µg/ kg to adult cancer patients a mean peak ic
a Pri odraslih onkoloških bolnikih je darbepoetin alfa po subkutani uporabi 2, 25 µg/ kg dosegel
concentration of 10.6 ng/ ml (SD 5.9) of darbepoetin alfa was reached at a mean time of 91 hours ed
nj povprečno največjo koncentracijo 10, 6 ng/ ml (standardni odklon 5, 9) v povprečno 91 urah (standardni odklon 19, 7).
Pharmacokinetic parameters did not M
Ti parametri se skladajo s farmakokinetiko, linearno povezano z odmerkom, v širokem lje odmernem območju (od 0, 5 do 8 µg/ kg na teden in od 3 do 9 µg/ kg na dva tedna).
change on multiple dosing over 12 weeks (dosing every week or every two weeks).
Med večkratnim odmerjanjem v teku 12 tednov (odmerjanje vsak teden ali na dva tedna) se farmakokinetični parametri vo niso spremenili.
A pharmacokinetic study in patients with chemotherapy-induced anaemia treated with 6.75 µg/ kg darbepoetin alfa administered SC every 3 weeks in combination with chemotherapy was conducted which allowed for full characterisation of the terminal half-life.
kemoterapije, ki so v kombinaciji s kemoterapijo dobivali 6, 75 µg/ kg darbepoetina alfa subkutano na 3 tedne, je omogočila popolno opredelitev terminalnega razpolovnega časa.
In this study, mean (SD) terminal half-life was 74 (SD 27) hours.
V tej študiji je bil povprečni terminalni razpolovni čas 74 ur (standardni odklon 27 ur). ā ve
In all studies in rats and dogs Nespo produced marked increases in haemoglobin, haematocrits, red blood cell counts and reticulocytes, which correspond to the expected pharmacological effects.
V vseh študijah pri podganah in psih je Nespo povzročil izrazito zvišanje hemoglobina, hematokrita, a
Adverse events at very high doses were all considered to be related to an exaggerated pharmacological
Vse m
23 effect (decreased tissue perfusion due to increased blood viscosity).
neželene učinke ob zelo velikih odmerkih so ocenili za posledice pretiranega farmakološkega delovanja (manjša perfuzija tkiva zaradi večje viskoznosti krvi).
These included myelofibrosis and splenic hypertrophy as well as broadening of the ECG-QRS complex in dogs but no dysrhythmia and no effect on the QT interval were observed.
hipertrofija vranice ter razširitev kompleksa QRS na EKG pri psih, vendar brez motenj srčnega ritma in brez vpliva na interval QT. ilo
In the chronic toxicity studies no tumourigenic or unexpected mitogenic responses were observed in any tissue type.
Kancerogenega potenciala darbepoetina alfa niso ocenili v ra
The carcinogenic potential of darbepoetin alfa has not been evaluated in long-term animal studies.
Zd
th Sodium phosphate monobasic Sodium phosphate dibasic
natrijev hidrogenfosfat
au Sodium chloride Polysorbate 80
23 natrijev dihidrogenfosfat natrijev klorid polisorbat 80 voda za injekcije
6.3 Shelf life ct
et 6. 3 Rok uporabnosti
2 years. du
m 2 leti.
6.4 Special precautions for storage ro
o 6. 4 Posebna navodila za shranjevanje
Store in a refrigerator (2°C – 8°C).
pr Shranjujte v hladilniku (pri temperaturi med 2ºC in 8ºC).
Do not freeze. lp
Ne zamrzujte.
Keep the container in the outer carton, in order to protect from light. a
za Vsebnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
period of seven days at room temperature (up to 25°C).
a sedemdnevno obdobje pri sobni temperaturi (do 25ºC).
Once a syringe has been removed from the ic
Ko brizgo vzamete iz hladilnika in doseže
refrigerator and has reached room temperature (up to 25°C) it must either be used within 7 days or disposed of. ed
nj sobno temperaturo (do 25ºC), jo morate uporabiti v 7 dneh, sicer jo morate zavreči. lje 6. 5 Vrsta ovojnine in vsebina vo Pakiranje z eno ali štirimi napolnjenimi injekcijskimi brizgami, v katerih je raztopina za injiciranje Nespo z 15 µg Nespa v 0, 375 ml (40 µg/ ml). do
Package containing one or four pre-filled syringe(s) of a 15 µg Nespo solution for injection in 0.375 ml (40 µg/ ml).
Injekcijske brizge so lahko v pakiranju s pretisnimi omoti (pakiranje z 1 oz.
The syringes may be presented in either blistered (1- & 4-pack) or non-blistered packaging (1-pack only).
4) ali brez pretisnih omotov (samo pakiranje z 1). ā
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex).
injekcijski brizgi vsebuje suho naravno gumo (derivat lateksa).
Not all packs may be marketed.
Na trgu ni vseh navedenih pakiranj. a m
24 6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje ni
Any medicinal product remaining in the pre-filled syringe should be disposed of.
Ostanek zdravila v napolnjeni injekcijski brizgi morate zavreči. ilo
Allow the pre- filled syringe to reach room temperature before injecting.
injiciranjem morate napolnjeno injekcijsko brizgo pustiti, da doseže sobno temperaturo. ra
Rotate the injection sites and inject slowly to avoid discomfort at the site of injection.
občutku na mestu injiciranja.
ed Any unused product or waste material should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
is 7.
24 7.
MARKETING AUTHORISATION NUMBERS er ng EU/ 1/ 01/ 184/ 003 1 Pack Blister lo EU/ 1/ 01/ 184/ 004 4 Pack Blister EU/ 1/ 01/ 184/ 034 1 Pack Unblistered no
et EU/ 1/ 01/ 184/ 003 – pakiranje po 1 v pretisnem omotu EU/ 1/ 01/ 184/ 004 – pakiranje po 4 v pretisnem omotu
9.
o pr 9.
Date of last renewal:
za Datum podaljšanja dovoljenja za promet:
Agency (EMEA) http: / /www. emea. europa. eu/ ed M
nj lje Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) vo http: // www. emea. europa. eu. / do ā ve a m ni ilo v ra Zd
27 individual variability, titration to optimal therapeutic doses is expected for individual patients.
Zaradi individualne variabilnosti je treba pričakovati, da bo pri posameznem bolniku potrebno titriranje do optimalnega terapevtskega odmerka.
28 increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
Če se hemoglobin po zmanjšanju odmerka še naprej zvišuje, uporabo začasno prekinite, dokler se hemoglobin ne začne zniževati; potem terapijo znova uvedite z odmerkom, približno 25% manjšim od prejšnjega.
29 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi Zd
Deficiencies of
29 Če se bolnik na terapijo z Nespom ne odzove, je treba raziskati vzročne dejavnike za to.
30 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
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
31 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje ra
For Nespo no clinical data on exposed pregnancies are available.
Zd
ed 4.7 Effects on ability to drive and use machines
31 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
32 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
or th • Pure Red Cell Aplasia.
32 • Čisto aplazijo rdečih celic.
The therapeutic margin of Nespo is very wide.
m Terapevtska meja Nespa je zelo široka.
In the event of polycythaemia, Nespo should be temporarily withheld (see section 4.2).
o pr V primeru policitemije je treba uporabo Nespa prehodno prekiniti (glejte poglavje 4. 2).
If clinically indicated, phlebotomy may be performed. ro lp
Narediti je mogoče flebotomijo, če je klinično indicirana.
5.
za 5.
5.1 Pharmacodynamic properties in
a 5. 1 Farmakodinamične lastnosti
Pharmacotherapeutic group:
nj 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.
B03XA02. lje Humani eritropoetin je endogen glikoproteinski hormon, ki primarno uravnava eritropoezo, in sicer vo preko specifične interakcije z eritropoetinskim receptorjem na eritroidnih matičnih celicah v kostnem mozgu.
The production of erythropoietin primarily occurs in and is regulated by the M
Eritropoetin nastaja predvsem v ledvicah, ki ga tudi uravnavajo v odziv na spremembe v do
kidney in response to changes in tissue oxygenation.
oksigenaciji tkiva.
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 ā
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
endogeni eritropoetin. ve
Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three.
Darbepoetin alfa spodbuja eritropoezo prek istih mehanizmov kot endogeni hormon.
The additional sugar residues are molecularly indistinct from those on the endogenous hormone.
Darbepoetin alfa ima pet N- vezanih ogljikohidratnih verig, endogeni hormon in rekombinantni humani eritropoetini a
Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater
Dodatne sladkorne skupine se molekulsko ne ločijo od tistih na endogenem m
33 in vivo activity.
hormonu.
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. ilo
Cancer patients receiving chemotherapy
Onkološki bolniki, ki dobivajo kemoterapijo v
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 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.
Zd
In both groups, the dose was
Bolnike so randomizirali na prejemanje Nespa 500 µg enkrat na tri tedne ali 2, 25 µg/ kg enkrat na teden.
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 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
au in a 14-day period.
33 teden), če se je hemoglobin v 14- dnevnem obdobju zvišal za več kot 10 g/ l.
Erythropoetin is a growth factor that primarily stimulates red blood cell production.
Receptorji za
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells. du
m eritropoetin so lahko izraženi na površini različnih tumorskih celic.