natgillin/translations-raw huggingface dataset:
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve
V kolikšni meri to velja za bolnike z rakom, ki prejemajo kemoterapijo in humani rekombinantni eritropoetin za dosego koncentracij hemoglobina, nižjih od 13 g/ dl, še ni jasno.
67 haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
V pregled podatkov je bilo namreč vključenih malo takih bolnikov.
Urea, Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate dihydrate, Disodium phosphate dodecahyrate, Calcium chloride dihydrate, Glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, L-Phenylalanine, Water for injections.
Sečnina, natrijev klorid, polisorbat 20, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dodekahidrat, kalcijev klorid dihidrat, glicin, L- levcin, L- izolevcin, L- treonin, L- glutaminska kislina, L- fenilalanin, voda za injekcije.
6.3 Shelf life
71 6. 3 Rok uporabnosti
68 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
0.3 ml of solution in pre-filled syringe (Type I glass) with a tip cap and a plunger stopper (teflonised rubber) with a needle 30G1/ 2.
0, 3 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z zaporko in zamaškom (iz gume, prevlečene s teflonom) ter injekcijsko iglo 30G1/ 2.
Pack sizes of 1 or 6 Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
EU/ 1/ 97/ 031/ 025 - 026
EU/ 1/ 97/ 031/ 025 − 026
NeoRecormon 1000 IU solution for injection in pre-filled syringe
NeoRecormon 1. 000 i. e. raztopina za injiciranje v napolnjeni injekcijski brizgi
One pre-filled syringe with 0.3 ml solution for injection contains 1000 international units (IU) corresponding to 8.3 micrograms epoetin beta* (recombinant human erythropoietin).
Ena napolnjena injekcijska brizga z 0, 3 ml raztopine za injiciranje vsebuje 1. 000 mednarodnih enot (i. e.), kar ustreza 8, 3 mikrogramom epoetina beta * (rekombinantni humani eritropoetin).
One ml solution for injection contains 3333 IU epoetin beta.
En ml raztopine za injiciranje vsebuje 3. 333 i. e. epoetina beta.
- Treatment of symptomatic anaemia associated with chronic renal failure (CRF) inadult and
- Zdravljenje simptomatske anemije, povezane s kronično ledvično odpovedjo pri odraslih in
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
74 Zdravljenje simptomatske anemije pri odraslih in pediatričnih bolnikih s kronično ledvično odpovedjo:
It can, however, be interrupted, if necessary, at any time.
75 Običajno je zdravljenje z zdravilom NeoRecormon dolgotrajno, vendar ga lahko kadarkoli prekinemo, če je potrebno.
Treatment for increasing the amount of autologous blood:
Povečanje količine avtologne krvi:
2 minutes or subcutaneously.
Raztopino dajemo intravensko približno 2 minuti ali subkutano.
During the entire treatment period, a PCV of 48% should not be exceeded.
76 Med celotnim potekom zdravljenja vrednost hematokrita ne sme preseči 48%.
73 The dosage must be determined by the surgical team individually for each patient as a function of the required amount of pre-donated blood and the endogenous red cell reserve:
Odmerjanje mora določiti kirurška ekipa za vsakega bolnika posamezno glede na potrebno količino vnaprej darovane krvi in endogeno rezervo rdečih krvničk:
In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.
77 Pri indikaciji za povečanje količine avtologne krvi: miokardni infarkt ali kap v preteklem mesecu, nestabilna angina pektoris, povečano tveganje globoke venske tromboze kot je venska trombembolična bolezen v anamnezi.
74 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer.
78 študijah niso dokazali, da bi epoetini izboljšali celokupno preživetje ali zmanjšali tveganje za napredovanje rasti tumorja pri bolnikih z anemijo, povezano z rakom.
This may be associated with life-threatening complications of the cardiovascular system.
79 Pri zdravih osebah lahko nepravilna uporaba zdravila čezmerno poveča hematokrit, kar lahko povzroči življenjsko nevarne zaplete kardiovaskularnega sistema.
76 This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i. e. essentially “ sodium-free”.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na injekcijsko brizgo, kar v bistvu pomeni 'brez natrija'.
Adverse Drug Reaction
80 Organski sistem Žilne bolezni
4.9 Overdose
81 4. 9 Preveliko odmerjanje
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
82 ogroženosti 1, 08 v dobro kontrolne skupine (95 -% interval zaupanja 0, 99; 1, 18; 42 preskušanj in 8167 bolnikov).
79 haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
V pregled podatkov je bilo namreč vključenih malo takih bolnikov.
6.3 Shelf life
83 6. 3 Rok uporabnosti
80 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
0.3 ml of solution in pre-filled syringe (Type I glass) with a tip cap and a plunger stopper (teflonised rubber) with a needle 27G1/ 2.
0, 3 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z zaporko in zamaškom (iz gume, prevlečene s teflonom) ter injekcijsko iglo 27G1/ 2.
EU/ 1/ 97/ 031/ 027 - 028
EU/ 1/ 97/ 031/ 027 − 028
NeoRecormon 2000 IU solution for injection in pre-filled syringe
NeoRecormon 2. 000 i. e. raztopina za injiciranje v napolnjeni injekcijski brizgi
One pre-filled syringe with 0.3 ml solution for injection contains 2000 international units (IU) corresponding to 16.6 micrograms epoetin beta* (recombinant human erythropoietin).
Ena napolnjena injekcijska brizga z 0, 3 ml raztopine za injiciranje vsebuje 2. 000 mednarodnih enot (i. e.), kar ustreza 16, 6 mikrogramom epoetina beta * (rekombinantni humani eritropoetin).
One ml solution for injection contains 6667 IU epoetin beta.
En ml raztopine za injiciranje vsebuje 6. 667 i. e. epoetina beta.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
86 Zdravljenje simptomatske anemije pri odraslih in pediatričnih bolnikih s kronično ledvično odpovedjo:
In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the weekly increase in Hb and the target Hb should be determined individually taking into account the clinical picture.
Bolnikom z visokim krvnim tlakom ali srčnožilnimi boleznimi, boleznimi možganskih ali perifernih žil, moramo tedensko povečanje koncentracije hemoglobina in njegovo ciljno vrednost določati individualno in upoštevati klinično sliko.
It can, however, be interrupted, if necessary, at any time.
87 Običajno je zdravljenje z zdravilom NeoRecormon dolgotrajno, vendar ga lahko kadarkoli prekinemo, če je potrebno.
During the entire treatment period, a PCV of 48% should not be exceeded.
88 Med celotnim potekom zdravljenja vrednost hematokrita ne sme preseči 48%.
85 The dosage must be determined by the surgical team individually for each patient as a function of the required amount of pre-donated blood and the endogenous red cell reserve:
Odmerjanje mora določiti kirurška ekipa za vsakega bolnika posamezno glede na potrebno količino vnaprej darovane krvi in endogeno rezervo rdečih krvničk:
In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.
89 Pri indikaciji za povečanje količine avtologne krvi: miokardni infarkt ali kap v preteklem mesecu, nestabilna angina pektoris, povečano tveganje globoke venske tromboze kot je venska trombembolična bolezen v anamnezi.
86 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
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 NeoRecormon (see section 4.8).
Bolnikov, za katere sumimo ali za katere je potrjeno, da imajo nevtralizirajoča protitelesa proti eritropoetinu, ne smemo začeti zdraviti z zdravilom NeoRecormon (glejte poglavje 4. 8)..
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer.
90 študijah niso dokazali, da bi epoetini izboljšali celokupno preživetje ali zmanjšali tveganje za napredovanje rasti tumorja pri bolnikih z anemijo, povezano z rakom.
This may be associated with life-threatening complications of the cardiovascular system.
91 Pri zdravih osebah lahko nepravilna uporaba zdravila čezmerno poveča hematokrit, kar lahko povzroči življenjsko nevarne zaplete kardiovaskularnega sistema.
88 This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i. e. essentially “ sodium-free”.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na injekcijsko brizgo, kar v bistvu pomeni 'brez natrija'.
Adverse Drug Reaction
92 Organski sistem Žilne bolezni
4.9 Overdose
93 4. 9 Preveliko odmerjanje
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
94 ogroženosti 1, 08 v dobro kontrolne skupine (95 -% interval zaupanja 0, 99; 1, 18; 42 preskušanj in 8167 bolnikov).
91 haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
V pregled podatkov je bilo namreč vključenih malo takih bolnikov.
6.3 Shelf life
95 6. 3 Rok uporabnosti
92 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
EU/ 1/ 97/ 031/ 029 - 030
EU/ 1/ 97/ 031/ 029 − 030
NeoRecormon 3000 IU solution for injection in pre-filled syringe
NeoRecormon 3. 000 i. e. raztopina za injiciranje v napolnjeni injekcijski brizgi
One pre-filled syringe with 0.3 ml solution for injection contains 3000 international units (IU) corresponding to 24.9 micrograms epoetin beta* (recombinant human erythropoietin).
Ena napolnjena injekcijska brizga z 0, 3 ml raztopine za injiciranje vsebuje 3. 000 mednarodnih enot (i. e.), kar ustreza 24, 9 mikrogramom epoetina beta * (rekombinantni humani eritropoetin).
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
98 Zdravljenje simptomatske anemije pri odraslih in pediatričnih bolnikih s kronično ledvično odpovedjo:
It can, however, be interrupted, if necessary, at any time.
99 Običajno je zdravljenje z zdravilom NeoRecormon dolgotrajno, vendar ga lahko kadarkoli prekinemo, če je potrebno.
During the entire treatment period, a PCV of 48% should not be exceeded.
100 Med celotnim potekom zdravljenja vrednost hematokrita ne sme preseči 48%.
97 The dosage must be determined by the surgical team individually for each patient as a function of the required amount of pre-donated blood and the endogenous red cell reserve:
Odmerjanje mora določiti kirurška ekipa za vsakega bolnika posamezno glede na potrebno količino vnaprej darovane krvi in endogeno rezervo rdečih krvničk:
In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.
101 Pri indikaciji za povečanje količine avtologne krvi: miokardni infarkt ali kap v preteklem mesecu, nestabilna angina pektoris, povečano tveganje globoke venske tromboze kot je venska trombembolična bolezen v anamnezi.
98 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer.
102 študijah niso dokazali, da bi epoetini izboljšali celokupno preživetje ali zmanjšali tveganje za napredovanje rasti tumorja pri bolnikih z anemijo, povezano z rakom.
This may be associated with life-threatening complications of the cardiovascular system.
103 Pri zdravih osebah lahko nepravilna uporaba zdravila čezmerno poveča hematokrit, kar lahko povzroči življenjsko nevarne zaplete kardiovaskularnega sistema.
100 This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i. e. essentially “ sodium-free”.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na injekcijsko brizgo, kar v bistvu pomeni 'brez natrija'.
Adverse Drug Reaction
104 Organski sistem Žilne bolezni
Epoetin beta treatment-related headache and hypertension which can be treated with drugs are common (> 1%, < 10%) (see section 4.4).
zdravljenjem z epoetinom beta povezana glavobol in hipertenzija, ki jo lahko zdravimo z zdravili, sta pogosta (> 1%, < 10%) (glejte poglavje 4. 4).
4.9 Overdose
105 4. 9 Preveliko odmerjanje
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
106 ogroženosti 1, 08 v dobro kontrolne skupine (95 -% interval zaupanja 0, 99; 1, 18; 42 preskušanj in 8167 bolnikov).
103 haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
V pregled podatkov je bilo namreč vključenih malo takih bolnikov.
6.3 Shelf life
107 6. 3 Rok uporabnosti
104 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
EU/ 1/ 97/ 031/ 031 - 032
EU/ 1/ 97/ 031/ 031 − 032
NeoRecormon 4000 IU solution for injection in pre-filled syringe
NeoRecormon 4. 000 i. e. raztopina za injiciranje v napolnjeni injekcijski brizgi
One pre-filled syringe with 0.3 ml solution for injection contains 4000 international units (IU) corresponding to 33.2 micrograms epoetin beta* (recombinant human erythropoietin).
Ena napolnjena injekcijska brizga z 0, 3 ml raztopine za injiciranje vsebuje 4. 000 mednarodnih enot (i. e.), kar ustreza 33, 2 mikrogramom epoetina beta * (rekombinantni humani eritropoetin).
One ml solution for injection contains 13,333 IU epoetin beta.
En ml raztopine za injiciranje vsebuje 13. 333 i. e. epoetina beta.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
110 Zdravljenje simptomatske anemije pri odraslih in pediatričnih bolnikih s kronično ledvično odpovedjo:
107 haemoglobin to not greater than 12 g/ dl (7.5 mmol/ l).
Zdravilo NeoRecormon lahko dajemo subkutano ali intravensko, da bi povečali koncentracijo hemoglobina do največ 12 g/ dl (7, 5 mmol/ l).
Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid puncture of peripheral veins. In case of intravenous administration, the solution should be injected over approx.
Pri bolnikih, ki niso na dializi, dajemo prednost subkutanemu dajanju, saj se tako izognemo punkciji perifernih ven.
It can, however, be interrupted, if necessary, at any time.
111 Običajno je zdravljenje z zdravilom NeoRecormon dolgotrajno, vendar ga lahko kadarkoli prekinemo, če je potrebno.
NeoRecormon should be administered by the subcutaneous route to patients with anaemia (e. g. haemoglobin concentration ≤ 10g/ dl (6.2 mmol/ l)).
Bolnikom z anemijo (npr. koncentracijo hemoglobina ≤ 10 g/ dl (6, 2 mmol/ l)) dajemo zdravilo NeoRecormon subkutano.
During the entire treatment period, a PCV of 48% should not be exceeded.
112 Med celotnim potekom zdravljenja vrednost hematokrita ne sme preseči 48%.
109 The dosage must be determined by the surgical team individually for each patient as a function of the required amount of pre-donated blood and the endogenous red cell reserve:
Odmerjanje mora določiti kirurška ekipa za vsakega bolnika posamezno glede na potrebno količino vnaprej darovane krvi in endogeno rezervo rdečih krvničk:
In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.
113 Pri indikaciji za povečanje količine avtologne krvi: miokardni infarkt ali kap v preteklem mesecu, nestabilna angina pektoris, povečano tveganje globoke venske tromboze kot je venska trombembolična bolezen v anamnezi.
110 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer.
114 študijah niso dokazali, da bi epoetini izboljšali celokupno preživetje ali zmanjšali tveganje za napredovanje rasti tumorja pri bolnikih z anemijo, povezano z rakom.
This may be associated with life-threatening complications of the cardiovascular system.
115 Pri zdravih osebah lahko nepravilna uporaba zdravila čezmerno poveča hematokrit, kar lahko povzroči življenjsko nevarne zaplete kardiovaskularnega sistema.
112 This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i. e. essentially “ sodium-free”.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na injekcijsko brizgo, kar v bistvu pomeni 'brez natrija'.
Adverse Drug Reaction
116 Organski sistem Žilne bolezni
4.9 Overdose
117 4. 9 Preveliko odmerjanje
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
118 ogroženosti 1, 08 v dobro kontrolne skupine (95 -% interval zaupanja 0, 99; 1, 18; 42 preskušanj in 8167 bolnikov).
115 haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
V pregled podatkov je bilo namreč vključenih malo takih bolnikov.
6.3 Shelf life
119 6. 3 Rok uporabnosti
116 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
EU/ 1/ 97/ 031/ 041 - 042
EU/ 1/ 97/ 031/ 041 − 042
NeoRecormon 5000 IU solution for injection in pre-filled syringe
NeoRecormon 5. 000 i. e. raztopina za injiciranje v napolnjeni injekcijski brizgi
One pre-filled syringe with 0.3 ml solution for injection contains 5000 international units (IU) corresponding to 41.5 micrograms epoetin beta* (recombinant human erythropoietin).
Ena napolnjena injekcijska brizga z 0, 3 ml raztopine za injiciranje vsebuje 5. 000 mednarodnih enot (i. e.), kar ustreza 41, 5 mikrogramom epoetina beta * (rekombinantni humani eritropoetin).
One ml solution for injection contains 16,667 IU epoetin beta.
En ml raztopine za injiciranje vsebuje 16. 667 i. e. epoetina beta.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
122 Zdravljenje simptomatske anemije pri odraslih in pediatričnih bolnikih s kronično ledvično odpovedjo:
It can, however, be interrupted, if necessary, at any time.
123 Običajno je zdravljenje z zdravilom NeoRecormon dolgotrajno, vendar ga lahko kadarkoli prekinemo, če je potrebno.
During the entire treatment period, a PCV of 48% should not be exceeded.
124 Med celotnim potekom zdravljenja vrednost hematokrita ne sme preseči 48%.
121 The dosage must be determined by the surgical team individually for each patient as a function of the required amount of pre-donated blood and the endogenous red cell reserve:
Odmerjanje mora določiti kirurška ekipa za vsakega bolnika posamezno glede na potrebno količino vnaprej darovane krvi in endogeno rezervo rdečih krvničk:
In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.
125 Pri indikaciji za povečanje količine avtologne krvi: miokardni infarkt ali kap v preteklem mesecu, nestabilna angina pektoris, povečano tveganje globoke venske tromboze kot je venska trombembolična bolezen v anamnezi.
122 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer.
126 študijah niso dokazali, da bi epoetini izboljšali celokupno preživetje ali zmanjšali tveganje za napredovanje rasti tumorja pri bolnikih z anemijo, povezano z rakom.
This may be associated with life-threatening complications of the cardiovascular system.
127 Pri zdravih osebah lahko nepravilna uporaba zdravila čezmerno poveča hematokrit, kar lahko povzroči življenjsko nevarne zaplete kardiovaskularnega sistema.
124 This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i. e. essentially “ sodium-free”.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na injekcijsko brizgo, kar v bistvu pomeni 'brez natrija'.
Adverse Drug Reaction
128 Organski sistem Žilne bolezni
4.9 Overdose
129 4. 9 Preveliko odmerjanje
The target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
Ciljne koncentracije hemoglobina so bile v dveh študijah > 13 g/ dl, v preostalih treh pa 12−14 g/ dl.
An individual patient data based meta-analysis, which included data from all 12 controlled clinical studies in anaemic cancer patients conducted with NeoRecormon (n=2301), showed an overall hazard ratio point estimate for survival of 1.13 in favour of controls (95% CI 0.87, 1.46).
Meta analiza podatkov posameznih bolnikov, v katero so bili vključeni podatki iz 12 vseh kontroliranih kliničnih študij, izvedenih z zdravilom NeoRecormon pri bolnikih z rakom, ki so imeli anemijo (n = 2301), je pokazala, da je ocena celokupnega razmerja ogroženosti za preživetje 1, 13 v prid kontrolni skupini (95 -% interval zaupanja 0, 87; 1, 46).
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
130 ogroženosti 1, 08 v dobro kontrolne skupine (95 -% interval zaupanja 0, 99; 1, 18; 42 preskušanj in 8167 bolnikov).
127 haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
V pregled podatkov je bilo namreč vključenih malo takih bolnikov.
6.3 Shelf life
131 6. 3 Rok uporabnosti
128 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
EU/ 1/ 97/ 031/ 033 - 034
EU/ 1/ 97/ 031/ 033 − 034
NeoRecormon 6000 IU solution for injection in pre-filled syringe
NeoRecormon 6. 000 i. e. raztopina za injiciranje v napolnjeni injekcijski brizgi
One pre-filled syringe with 0.3 ml solution for injection contains 6000 international units (IU) corresponding to 49.8 micrograms epoetin beta* (recombinant human erythropoietin).
Ena napolnjena injekcijska brizga z 0, 3 ml raztopine za injiciranje vsebuje 6. 000 mednarodnih enot (i. e.), kar ustreza 49, 8 mikrogramom epoetina beta * (rekombinantni humani eritropoetin).
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
134 Zdravljenje simptomatske anemije pri odraslih in pediatričnih bolnikih s kronično ledvično odpovedjo:
Maintenance phase To maintain an Hb of between 10 and 12 g/ dl, the dosage is initially reduced to half of the previously administered amount.
Vzdrževalna stopnja Da bi ohranili koncentracije hemoglobina med 10 in 12 g/ dl, odmerek najprej zmanjšamo na polovico dotedanjega.
It can, however, be interrupted, if necessary, at any time.
135 Običajno je zdravljenje z zdravilom NeoRecormon dolgotrajno, vendar ga lahko kadarkoli prekinemo, če je potrebno.
During the entire treatment period, a PCV of 48% should not be exceeded.
136 Med celotnim potekom zdravljenja vrednost hematokrita ne sme preseči 48%.
133 The dosage must be determined by the surgical team individually for each patient as a function of the required amount of pre-donated blood and the endogenous red cell reserve:
Odmerjanje mora določiti kirurška ekipa za vsakega bolnika posamezno glede na potrebno količino vnaprej darovane krvi in endogeno rezervo rdečih krvničk: