natgillin/translations-raw huggingface dataset:
1.35, 2.06, 35 trials and 6’ 769 patients) was observed in patients treated with recombinant human erythropoietin.
Pri bolnikih, zdravljenih z rekombinantnim humanim eritropetinom, so opazili povečano relativno tveganje za trombembolične dogodke (relativno tveganje 1, 67; 95 -% interval zaupanja 1, 35; 2, 06; 35 preskušanj in 6769 bolnikov).
Following subcutaneous administration to CKD patients on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 72 hours (median value) after administration.
Absolutna biološka
The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 62% and the observed terminal elimination half-life was 139 hours in CKD patients on dialysis.
15 uporabnost metoksipolietilenglikol epoetina beta po subkutanem dajanju je bila 62%, ugotovljeni končni razpolovni čas izločanja pri dializnih bolnikih s kronično ledvično boleznijo pa 139 ur.
Following intravenous administration to CKD patients on dialysis, the total systemic clearance was 0.494 ml/ h per kg.
Po intravenskem dajanju pri dializnih bolnikih s kronično ledvično boleznijo je skupni sistemski očistek znašal 0, 494 ml/ h na kg.
15 A comparison of serum concentrations of methoxy polyethylene glycol-epoetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
Primerjava serumskih koncentracij metoksipolietilenglikol epoetina beta, ki so jih izmerili pred hemodializo in po njej pri 41 bolnikih s kronično ledvično boleznijo, je pokazala, da hemodializa na farmakokinetiko tega zdravila ne vpliva.
In a single dose study, after intravenous administration, the pharmacokinetics of methoxy polyethylene glycol-epoetin beta are similar in patients with severe hepatic impairment as compared to healthy subjects (see section 4.2).
V študiji enkratnega odmerjanja je bila po intravenskem dajanju zdravila farmakokinetika metoksipolietilenglikol epoetina beta pri bolnikih s hudo jetrno okvaro podobna tisti pri zdravih osebah (glejte poglavje 4. 2).
No significant placental transfer of methoxy polyethylene glycol-epoetin beta was observed in the rat, and studies in animals have not shown any harmful effect on pregnancy, embryofoetal development, parturition or postnatal development.
Pri podganah pomembnega prehajanja metoksipolietilenglikol epoetina beta skozi placento niso opazili.
When methoxy polyethylene glycol-epoetin beta was administered subcutaneously to male and female rats prior to and during mating, reproductive performance, fertility, and sperm assessment parameters were not affected.
Ko so metoksipolietilenglikol epoetin beta dajali subkutano podganjim samcem in samicam pred parjenjem in po njem, ni bilo vpliva na ocenjevane parametre za sposobnost razmnoževanja, plodnost in seme.
16 Keep the vial in the outer carton in order to protect from light The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 25°C for one single period of 1 month.
Končni uporabnik lahko zdravilo vzame iz hladilnika in ga hrani pri sobni temperaturi (ne nad 25 °C) za enkratno obdobje 1 meseca.
MIRCERA 200 micrograms/ ml solution for injection
MIRCERA 200 mikrogramov/ ml raztopina za injiciranje
1 ml (one vial) contains 200 micrograms of methoxy polyethylene glycol-epoetin beta*.
1 ml (ena viala) vsebuje 200 mikrogramov metoksipolietilenglikol epoetina beta *.
18 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
18 Bolnike je treba pozorno spremljati, da lahko simptome anemije ustrezno nadzorujemo s čim manjšim odobrenim odmerkom zdravila MIRCERA.
19 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
19 Ker so izkušnje z zdravljenjem pri bolnikih na peritonealni dializi omejene, je pri teh bolnikih priporočljivo redno spremljanje koncentracij hemoglobina in dosledno upoštevanje navodil za prilagajanje odmerkov.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12g/ dl (7.5 mmol/ l).
20 bila ciljna koncentracija hemoglobina dosežena z zdravili za stimulacijo eritropoeze nad 12 g/ dl (7, 5 mmol/ l).
20 Blood pressure monitoring:
Kontrola krvnega tlaka:
21 Table 2:
21 zdravilom MIRCERA.
In responding to hypoxia, the natural hormone erythropoietin interacts with erythroid progenitor cells to increase red cell production.
V 22 odgovoru na hipoksijo pride do interakcije med naravnim hormonom eritropoetinom in progenitornimi matičnimi celicami za eritrocite, kar poveča tvorbo rdečih krvnih celic.
22 on dialysis, respectively) and comparable to comparators (91.3% and 96.3%, respectively).
Mediana časa do odgovora na zdravljenje je bila v skupini, ki je prejemala zdravilo MIRCERA, 43 dni (povečanje koncentracije hemoglobina v prvih 6 tednih je znašalo 0, 2 g/ dl/ teden).
The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 62% and the observed terminal elimination half-life was 139 hours in CKD patients on dialysis.
23 uporabnost metoksipolietilenglikol epoetina beta po subkutanem dajanju je bila 62%, ugotovljeni končni razpolovni čas izločanja pri dializnih bolnikih s kronično ledvično boleznijo pa 139 ur.
23 A comparison of serum concentrations of methoxy polyethylene glycol-epoetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
Primerjava serumskih koncentracij metoksipolietilenglikol epoetina beta, ki so jih izmerili pred hemodializo in po njej pri 41 bolnikih s kronično ledvično boleznijo, je pokazala, da hemodializa na farmakokinetiko tega zdravila ne vpliva.
24 Keep the vial in the outer carton in order to protect from light The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 25°C for one single period of 1 month.
Končni uporabnik lahko zdravilo vzame iz hladilnika in ga hrani pri sobni temperaturi (ne nad 25 °C) za enkratno obdobje 1 meseca.
MIRCERA 300 micrograms/ ml solution for injection
MIRCERA 300 mikrogramov/ ml raztopina za injiciranje
1 ml (one vial) contains 300 micrograms of methoxy polyethylene glycol-epoetin beta*.
1 ml (ena viala) vsebuje 300 mikrogramov metoksipolietilenglikol epoetina beta *.
A rise in haemoglobin of greater than 2 g/ dl (1.24 mmol/ l) over a four-week period should be avoided.
26 Povečanju koncentracije hemoglobina za več kot 2 g/ dl (1, 24 mmol/ l) v štirih tednih se je treba izogibati.
26 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
Bolnike je treba pozorno spremljati, da lahko simptome anemije ustrezno nadzorujemo s čim manjšim odobrenim odmerkom zdravila MIRCERA.
The first injection should start at the next scheduled dose of the previously administered darbepoetin alfa or epoetin.
Uvajalni odmerki zdravila MIRCERA Mesečni odmerek
Table 1:
zdravila MIRCERA,
MIRCERA starting doses
odmerek
If the haemoglobin level continues to increase, therapy should be interrupted until the haemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose.
Po prekinitvi dajanja je pričakovani padec koncentracije hemoglobina
After dose interruption a haemoglobin decrease of approximately 0.35 g/ dl (0.22 mmol/ l) per week is expected.
27 približno 0, 35 g/ dl (0, 22 mmol/ l) na teden.
27 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
Ker so izkušnje z zdravljenjem pri bolnikih na peritonealni dializi omejene, je pri teh bolnikih priporočljivo redno spremljanje koncentracij hemoglobina in dosledno upoštevanje navodil za prilagajanje odmerkov.
In patients with chronic kidney disease, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
Pri bolnikih s kronično ledvično odpovedjo vzdrževana koncentracija hemoglobina ne sme preseči zgornje meje ciljne koncentracije hemoglobina, priporočene v poglavju
In clinical trials, an increased risk of death and serious cardiovascular events 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 preskušanjih so opazili povečano tveganje za smrt in resne srčnožilne dogodke, če je bila ciljna koncentracija hemoglobina dosežena z zdravili za stimulacijo eritropoeze nad 12 g/ dl (7, 5 mmol/ l).
28 Blood pressure monitoring:
Kontrola krvnega tlaka:
29 Table 2:
29 zdravilom MIRCERA.
In responding to hypoxia, the natural hormone erythropoietin interacts with erythroid progenitor cells to increase red cell production.
V 30 odgovoru na hipoksijo pride do interakcije med naravnim hormonom eritropoetinom in progenitornimi matičnimi celicami za eritrocite, kar poveča tvorbo rdečih krvnih celic.
30 on dialysis, respectively) and comparable to comparators (91.3% and 96.3%, respectively).
Mediana časa do odgovora na zdravljenje je bila v skupini, ki je prejemala zdravilo MIRCERA, 43 dni (povečanje koncentracije hemoglobina v prvih 6 tednih je znašalo 0, 2 g/ dl/ teden).
Patients were randomized to stay on their treatment at the time of enrollmet or to be switched to MIRCERA in order to maintain stable haemoglobin levels.
Bolnike so razvrstili tako, da so ostali na zdravljenju, ki so ga prejemali ob času vstopa v raziskavo ali pa so prešli na zdravilo MIRCERA, z namenom vzdrževati stabilno koncentracijo hemoglobina.
The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 62% and the observed terminal elimination half-life was 139 hours in CKD patients on dialysis.
31 uporabnost metoksipolietilenglikol epoetina beta po subkutanem dajanju je bila 62%, ugotovljeni končni razpolovni čas izločanja pri dializnih bolnikih s kronično ledvično boleznijo pa 139 ur.
31 A comparison of serum concentrations of methoxy polyethylene glycol-epoetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
Primerjava serumskih koncentracij metoksipolietilenglikol epoetina beta, ki so jih izmerili pred hemodializo in po njej pri 41 bolnikih s kronično ledvično boleznijo, je pokazala, da hemodializa na farmakokinetiko tega zdravila ne vpliva.
6.3 Shelf life
32 6. 3 Rok uporabnosti
32 Keep the vial in the outer carton in order to protect from light The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 25°C for one single period of 1 month.
Končni uporabnik lahko zdravilo vzame iz hladilnika in ga hrani pri sobni temperaturi (ne nad 25 °C) za enkratno obdobje 1 meseca.
MIRCERA 400 micrograms/ ml solution for injection
MIRCERA 400 mikrogramov/ ml raztopina za injiciranje
1 ml (one vial) contains 400 micrograms of methoxy polyethylene glycol-epoetin beta*.
1 ml (ena viala) vsebuje 400 mikrogramov metoksipolietilenglikol epoetina beta *.
34 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
34 Bolnike je treba pozorno spremljati, da lahko simptome anemije ustrezno nadzorujemo s čim manjšim odobrenim odmerkom zdravila MIRCERA.
35 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
35 Ker so izkušnje z zdravljenjem pri bolnikih na peritonealni dializi omejene, je pri teh bolnikih priporočljivo redno spremljanje koncentracij hemoglobina in dosledno upoštevanje navodil za prilagajanje odmerkov.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dl (7.5 mmol/ l).
36 bila ciljna koncentracija hemoglobina dosežena z zdravili za stimulacijo eritropoeze nad 12 g/ dl (7, 5 mmol/ l).
36 Blood pressure monitoring:
Kontrola krvnega tlaka:
37 Table 2:
37 zdravilom MIRCERA.
In responding to hypoxia, the natural hormone erythropoietin interacts with erythroid progenitor cells to increase red cell production.
V 38 odgovoru na hipoksijo pride do interakcije med naravnim hormonom eritropoetinom in progenitornimi matičnimi celicami za eritrocite, kar poveča tvorbo rdečih krvnih celic.
38 on dialysis, respectively) and comparable to comparators (91.3% and 96.3%, respectively).
Mediana časa do odgovora na zdravljenje je bila v skupini, ki je prejemala zdravilo MIRCERA, 43 dni (povečanje koncentracije hemoglobina v prvih 6 tednih je znašalo 0, 2 g/ dl/ teden).
The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 62% and the observed terminal elimination half-life was 139 hours in CKD patients on dialysis.
39 uporabnost metoksipolietilenglikol epoetina beta po subkutanem dajanju je bila 62%, ugotovljeni končni razpolovni čas izločanja pri dializnih bolnikih s kronično ledvično boleznijo pa 139 ur.
39 A comparison of serum concentrations of methoxy polyethylene glycol-epoetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
Primerjava serumskih koncentracij metoksipolietilenglikol epoetina beta, ki so jih izmerili pred hemodializo in po njej pri 41 bolnikih s kronično ledvično boleznijo, je pokazala, da hemodializa na farmakokinetiko tega zdravila ne vpliva.
In the absence of compatibility studies, this medicinalmproduct must not be mixed with other medicinal products.
6. 2 Inkompatibilnosti
6.3 Shelf life
40 6. 3 Rok uporabnosti
40 Keep the vial in the outer carton in order to protect from light The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 25°C for one single period of 1 month.
Končni uporabnik lahko zdravilo vzame iz hladilnika in ga hrani pri sobni temperaturi (ne nad 25 °C) za enkratno obdobje 1 meseca.
MIRCERA 600 micrograms/ ml solution for injection
MIRCERA 600 mikrogramov/ ml raztopina za injiciranje
1 ml (one vial) contains 600 micrograms of methoxy polyethylene glycol-epoetin beta*.
1 ml (ena viala) vsebuje 600 mikrogramov metoksipolietilenglikol epoetina beta *.
A rise in haemoglobin of greater than 2 g/ dl (1.24 mmol/ l) over a four-week period should be avoided.
42 Povečanju koncentracije hemoglobina za več kot 2 g/ dl (1, 24 mmol/ l) v štirih tednih se je treba izogibati.
42 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
Bolnike je treba pozorno spremljati, da lahko simptome anemije ustrezno nadzorujemo s čim manjšim odobrenim odmerkom zdravila MIRCERA.
After dose interruption a haemoglobin decrease of approximately 0.35 g/ dl (0.22 mmol/ l) per week is expected.
43 približno 0, 35 g/ dl (0, 22 mmol/ l) na teden.
43 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
Ker so izkušnje z zdravljenjem pri bolnikih na peritonealni dializi omejene, je pri teh bolnikih priporočljivo redno spremljanje koncentracij hemoglobina in dosledno upoštevanje navodil za prilagajanje odmerkov.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12g/ dl (7.5 mmol/ l).
V kliničnih preskušanjih so opazili povečano tveganje za smrt in resne srčnožilne dogodke, če je bila ciljna koncentracija hemoglobina dosežena z zdravili za stimulacijo eritropoeze nad 12 g/ dl (7, 5 mmol/ l).
44 Blood pressure monitoring:
Kontrola krvnega tlaka:
45 Table 2:
45 zdravilom MIRCERA.
In responding to hypoxia, the natural hormone erythropoietin interacts with erythroid progenitor cells to increase red cell production.
V 46 odgovoru na hipoksijo pride do interakcije med naravnim hormonom eritropoetinom in progenitornimi matičnimi celicami za eritrocite, kar poveča tvorbo rdečih krvnih celic.
Data from correction studies show that the haemoglobin response rates in the MIRCERA group at the end of the correction period were high (93.3% and 97.5% in the studies in patients on dialysis and not
Podatki iz študij, ki so proučevale fazo korekcije, kažejo, da so bili na koncu faze korekcije deleži povečanja hemoglobina v skupini, ki je prejemala zdravilo MIRCERA, visoki (93, 3% pri dializnih bolnikih in 97, 5% pri nedializnih bolnikih) in primerljivi z deleži v primerjalni skupini (91, 3% in 96, 3%).
46 on dialysis, respectively) and comparable to comparators (91.3% and 96.3%, respectively).
Mediana časa do odgovora na zdravljenje je bila v skupini, ki je prejemala zdravilo MIRCERA, 43 dni (povečanje koncentracije hemoglobina v prvih 6 tednih je znašalo 0, 2 g/ dl/ teden).
The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 62% and the observed terminal elimination half-life was 139 hours in CKD patients on dialysis.
47 uporabnost metoksipolietilenglikol epoetina beta po subkutanem dajanju je bila 62%, ugotovljeni končni razpolovni čas izločanja pri dializnih bolnikih s kronično ledvično boleznijo pa 139 ur.
47 A comparison of serum concentrations of methoxy polyethylene glycol-epoetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
Primerjava serumskih koncentracij metoksipolietilenglikol epoetina beta, ki so jih izmerili pred hemodializo in po njej pri 41 bolnikih s kronično ledvično boleznijo, je pokazala, da hemodializa na farmakokinetiko tega zdravila ne vpliva.
Store in a refrigerator (2°C – 8°C) Do not freeze Keep the vial in the outer carton in order to protect from light
Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
48 The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 25°C for one single period of 1 month.
Končni uporabnik lahko zdravilo vzame iz hladilnika in ga hrani pri sobni temperaturi (ne nad 25 °C) za enkratno obdobje 1 meseca.
MIRCERA 1000 micrograms/ ml solution for injection
MIRCERA 1000 mikrogramov/ ml raztopina za injiciranje
1 ml (one vial) contains 1000 micrograms of methoxy polyethylene glycol-epoetin beta*.
1 ml (ena viala) vsebuje 1000 mikrogramov metoksipolietilenglikol epoetina beta *.
A rise in haemoglobin of greater than 2 g/ dl (1.24 mmol/ l) over a four-week period should be avoided.
Izogibati se moramo povečanju koncentracije hemoglobina za več kot 2 g/ dl (1, 24 mmol/ l) v štirih tednih.
50 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
50 Bolnike je treba pozorno spremljati, da lahko simptome anemije ustrezno nadzorujemo s čim manjšim odobrenim odmerkom zdravila MIRCERA.
51 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
51 Ker so izkušnje z zdravljenjem pri bolnikih na peritonealni dializi omejene, je pri teh bolnikih priporočljivo redno spremljanje koncentracij hemoglobina in dosledno upoštevanje navodil za prilagajanje odmerkov.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dl (7.5 mmol/ l).
52 bila ciljna koncentracija hemoglobina dosežena z zdravili za stimulacijo eritropoeze nad 12 g/ dl (7, 5 mmol/ l).
52 Blood pressure monitoring:
Kontrola krvnega tlaka:
53 Table 2:
53 zdravilom MIRCERA.
In responding to hypoxia, the natural hormone erythropoietin interacts with erythroid progenitor cells to increase red cell production.
V 54 odgovoru na hipoksijo pride do interakcije med naravnim hormonom eritropoetinom in progenitornimi matičnimi celicami za eritrocite, kar poveča tvorbo rdečih krvnih celic.
54 on dialysis, respectively) and comparable to comparators (91.3% and 96.3%, respectively).
Mediana časa do odgovora na zdravljenje je bila v skupini, ki je prejemala zdravilo MIRCERA, 43 dni (povečanje koncentracije hemoglobina v prvih 6 tednih je znašalo 0, 2 g/ dl/ teden).
The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 62% and the observed terminal elimination half-life was 139 hours in CKD patients on dialysis.
55 uporabnost metoksipolietilenglikol epoetina beta po subkutanem dajanju je bila 62%, ugotovljeni končni razpolovni čas izločanja pri dializnih bolnikih s kronično ledvično boleznijo pa 139 ur.
55 A comparison of serum concentrations of methoxy polyethylene glycol-epoetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
Primerjava serumskih koncentracij metoksipolietilenglikol epoetina beta, ki so jih izmerili pred hemodializo in po njej pri 41 bolnikih s kronično ledvično boleznijo, je pokazala, da hemodializa na farmakokinetiko tega zdravila ne vpliva.
56 Keep the vial in the outer carton in order to protect from light The end-user may remove the medicinal product from refrigeration for storage at a room temperature not above 25°C for one single period of 1 month.
Končni uporabnik lahko zdravilo vzame iz hladilnika in ga hrani pri sobni temperaturi (ne nad 25 °C) za enkratno obdobje 1 meseca.
MIRCERA 50 micrograms/ 0.3 ml solution for injection in pre-filled syringe
MIRCERA 50 mikrogramov/ 0, 3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 167 micrograms/ ml.
Ena napolnjena injekcijska brizga vsebuje 50 mikrogramov metoksipolietilenglikol epoetina beta * s koncentracijo 167 mikrogramov/ ml.
58 Patients should be monitored closely to ensure that the lowest approved dose of MIRCERA is used to provide adequate control of the symptoms of anaemia.
58 Bolnike je treba pozorno spremljati, da lahko simptome anemije ustrezno nadzorujemo s čim manjšim odobrenim odmerkom zdravila MIRCERA.
The recommended starting dose is 0.6 microgram/ kg body weight, administered once every two weeks as a single intravenous or subcutaneous injection in order to increase haemoglobin levelsto greater than 10 g/ dl (6.21 mmol/ l).
Bolniki, ki se trenutno ne zdravijo z zdravili za stimulacijo eritropoeze Priporočeni začetni odmerek 0, 6 mikrograma/ kg telesne mase damo enkrat na dva tedna kot eno intravensko ali subkutano injekcijo z namenom, da bi povečali koncentracijo hemoglobina nad 10 g/ dl (6, 21 mmol/ l).
59 Since the treatment experience is limited in patients on peritoneal dialysis, regular haemoglobin monitoring and strict adherence to dose adjustment guidance is recommended in these patients.
59 Ker so izkušnje z zdravljenjem pri bolnikih na peritonealni dializi omejene, je pri teh bolnikih priporočljivo redno spremljanje koncentracij hemoglobina in dosledno upoštevanje navodil za prilagajanje odmerkov.