natgillin/translations-raw huggingface dataset:
200-300 mg/ day orally (100-200 mg/ day for paediatric patients) is recommended for chronic renal failure patients whose serum ferritin levels are below 100 ng/ ml − oral iron substitution of 200-300 mg/ day is recommended for all cancer patients whose transferrin saturation is below 20%.
200- 300 mg na dan peroralno (100- 200 mg na dan za pediatrične bolnike) se priporoča za bolnike s kronično odpovedjo ledvic, ki imajo nivoje feritina v serumu pod 100 ng/ ml. − peroralno nadomeščanje železa z 200- 300 mg/ dan se priporoča za vse bolnike z rakom, pri katerih je nasičenost transferina pod 20%.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially ‘ sodium-free’.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ´brez natrija´.
Chronic renal failure patients
Bolniki s kronično ledvično odpovedjo
Immunogenicity data for subcutaneous use of Retacrit in patients at risk for antibody-induced Pure Red Cell Aplasia (PRCA), i. e. patients with renal anaemia, are not sufficient.
Imunogenski podatki za subkutano uporabo zdravila Retacrit pri bolnikih, s tveganjem za s protitelesi povzročene čiste aplazije rdečih krvnih celic (PRCA), t. j. pri bolnikih z ledvično anemijo, so nezadostni.
Therefore, in patients with renal anaemia the medicinal product has to be administered intravenously.
Zato je treba pri bolnikih z ledvično anemijo zdravilo dajati intravensko.
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 ledvično odpovedjo vzdrževalna koncentracija hemoglobina ne sme presegati zgornje meje priporočene ciljne koncentracije hemoglobina, ki je podana v poglavju 4. 2.
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 kardiovaskularne dogodke, kadar so zdravila za stimulacijo eritropoeze (ESA) dajali, da bi dosegli ciljno koncentracijo hemoglobina, ki presega 12 g/ dl (7, 5 mmol/ l).
The rate of increase in haemoglobin should be approximately 1 g/ dl (0.62 mmol/ l) per month and should not exceed 2 g/ dl (1.25 mmol/ l) per month to minimize the risk of developing or worsening of hypertension.
Hitrost, s katero se dviga hemoglobin, naj bi bila približno 1g/ dl (0, 62 mmol/ l) na mesec in naj ne bi presegala 2g/ dl (1, 25 mmol/ l) na mesec, da se zmanjša tveganje za razvoj ali poslabšanje hipertenzije.
Non response to erythropoietin therapy should prompt a search for causative factors.
Ob neodzivanje na zdravljenje z eritropoetinom je treba iskati faktorje, ki to pozročajo.
Cases of antibody-mediated PRCA have been very rarely reported in chronic renal failure patients with erythropoietin administered by the subcutaneous route.
Pri bolnikih s kronično ledvično odpovedjo, ki se jih je zdravilo s subkutanimi injekcijami eritropoetina, so v zelo redkih primerih poročali o PRCA, do katere je prišlo zaradi protiteles.
In patients developing sudden lack of efficacy, defined by a decrease in haemoglobin (1-2 g/ dl per month) with increased need for transfusions, a reticulocyte count should be obtained and typical causes of non-response (e. g. iron, folate, or Vitamin B12-deficiency, aluminium intoxication, infection or inflammation, blood loss, and haemolysis) should be investigated.
Pri bolnikih, pri katerih pride nenadoma do zmanjšanja učinkovitosti, definiranega kot zvišanje hemoglobina (1- 2 g/ dl na mesec) ob povečani potrebi po transfuzijah, je treba izmeriti število retikulocitov in raziskati tipične vzroke za zmanjšanje učinkovitosti (npr. pomanjkanje železa, folata, vitamina B12, zastrupitev z aluminijem, okužbe ali vnetja, izguba krvi in hemoliza).
Patients should not be switched to another medicinal
Druge vzroke za PRCA je treba izključiti in začeti z ustrezno terapijo.
7 product as anti-erythropoietin antibodies cross-react with other erythropoietins.
Priporoča se reden nadzor števila retikulocitov, ker se s tem pri bolnikih s kronično ledvično
Monitoring of reticulocyte count on a regular basis is recommended to detect possible occurrence of lack of efficacy in chronic renal failure patients.
8 odpovedjo lahko ugotovi možna odsotnost učinkovitosti zdravljenja.
In chronic renal failure patients, correction for anaemia may lead to increased appetite, and potassium and protein intake.
Pri bolnikih s kronično ledvično odpovedjo je popravek anemije imel za posledico povečan apetit, in povečan vnos kalija in proteinov.
Serum electrolytes should be monitored in chronic renal failure patients.
Pri bolnikih s kronično ledvično odpovedjo je treba meriti elektrolite v serumu.
In cancer patients receiving chemotherapy, the 2-3 week delay between erythropoietin administration and the appearance of erythropoietin-induced red cells should be taken into account when assessing if Retacrit therapy is appropriate (patient at risk of being transfused).
Pri rakavih bolnikih na kemoterapiji je treba pri vprašanju, ali je zdravljenje z zdravilom Retacrit primerno (bolniki s povečanim tveganjem pri transfuzijah), upoštevati 2- 3 tedenski zamik med začetkom dajanja eritropoetina in pojavom eritrocitov, ki jih eritropoetin inducira.
If the rate of increase in haemoglobin exceeds 2 g/ dl (1.25 mmol/ l) per month or the haemoglobin level exceeds 12 g/ dl (7.5 mmol/ l), the dose adjustment detailed in section 4.2 should be thoroughly performed to minimise the risk of thrombotic events (see section 4.2).
Če hitrost naraščanja hemoglobina presega 2 g/ dl (1, 25 mmol/ l) na mesec ali če nivo hemoglobina presega 12 g/ dl (7, 5 mmol/ l), je potrebno opraviti korenito spremembo odmerka, kot je navedeno v poglavju 4. 2, da bi se zmanjšalo riziko tveganja za trombotične zaplete (glejte poglavje 4. 2)
As an increased incidence of thrombotic vascular events (TVEs) has been observed in cancer patients receiving erythropoietic agents (see section 4.8), this risk should be carefully weighed against the benefit to be derived from treatment (with Retacrit) particularly in cancer patients with an increased risk of thrombotic vascular events, such as obesity and patients with a prior history of TVEs (e. g. deep venous thrombosis or pulmonary embolism).
Posebna pozornost je potrebna pri bolnikih z rakom, pri katerih je prisoto povečano tveganje ta trombotične vaskularne zaplete, na primer zaradi debelosti, ali pa zaradi trombotičnih vaskularnih zapletov v anamnezi (npr. globoka venozna tromboza ali pljučna embolija):
In controlled clinical studies, use of Epoetin alfa and other erythropoiesis-stimulating agents (ESAs) have shown:
V kontroliranih kliničnih študijah je prišlo pri uporabi epoetina alfa in drugih zdravil za stimulacijo eritropoeze (ESA) do: • skrajšanega časa do napredovanja tumorja pri bolnikih z napredovalim rakom glave in vratu, ki prejemajo terapijo z obsevanjem pri dajanju zdravil z namenom doseči ciljne koncentracije hemoglobina, ki so večje od 14 g/ dl (8, 7 mmol/ l), • skrajšanega časa skupnega preživetja in povečanja števila smrti, ki jih pripisujejo
8 • 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), • 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), 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.
9 napredovanju bolezni po 4 mesecih pri bolnikih z metastaznim rakom dojk na kemoterapiji, pri katerih so z uporabo sredstev za stimulacijo eritropoeze želeli doseči ciljne koncentracije hemoglobina od 12– 14 g/ dl (7, 5– 8, 7 mmol/ l), • povečanega tveganja smrti pri dajanju omenjenih zdravil, da bi dosegli ciljno koncentracijo hemoglobina, ki znaša 12 g/ dl (7, 5 mmol/ l) pri bolnikih z aktivno maligno boleznijo, ki ne prejemajo kemoterapije niti terapije z obsevanjem.
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)
Dejavnike, ki bi jih morali upoštevati pri tej oceni, morajo vključevati tip tumorja in njegov stadij, stopnjo anemičnosti, pričakovano življenjsko dobo, okolje v katerem se bolnika zdravi in prednosti za bolnika (glejte poglavje 5. 1).
No evidence exists that indicates an interaction between epoetin alfa and G-CSF or GM-CSF with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro.
Ni dokazov za medsebojno delovanje med epoetinom alfa in G- CSF ali GM- CSF glede na in vitro hematološko diferenciacijo ali proliferacijo vzorcev tumorjev, ki so bili pridobljeni z biopsijo.
Studies in animals have shown reproduction toxicity (see section 5.3).
Študije na živalih kažejo vpliv na sposobnost razmnoževanja (glejte poglavje 5. 3).
Retacrit is a biological medicinal product.
Zdravilo Retacrit je biološko zdravilo.
Hypertensive crisis with encephalopathy-like symptoms can occur.
V glavnem se neželeni učinki med zdravljenjem z eritropoetinom pojavijo pri bolnikih s kronično ledvično odpovedjo ali malignimi obolenji, izrazijo pa se najpogosteje kot z odmerkom povezano z glavobol in zvišanjem krvnega tlaka Nastopi lahko hipertenzivna kriza s simptomi, ki so podobni encefalopatiji.
General Non-specific skin rashes have been described with epoetin alfa.
Splošni V povezavi z epoetinom alfa so poročali o nespecifičnih kožnih izpuščajih.
9 Thrombocytosis has been observed but its occurrence is very rare (see section 4.4).
Opazili so tudi trombocitozo, vendar se je pojavila zelo redko (glejte poglavje 4. 4).
Thrombotic/ vascular events, such as myocardial ischaemia, myocardial infarction, cerebrovascular accidents (cerebral haemorrhage and cerebral infarction), transient ischaemic attacks, deep vein thrombosis, arterial thrombosis, pulmonary emboli, aneurysms, retinal thrombosis, and clotting of an artificial kidney have been reported in patients receiving erythropoietic agents.
Pri bolnikih, ki so prejemali eritropoetine, so poročali o trombotičnih/ vaskularnih
In most of these patients, antibodies to erythropoietins have been observed (see sections 4.3 and 4.4)
Pri večini teh bolnikov so opazili prisotnost eritropoetinskih protiteles (glejte poglavji 4. 3 in 4. 4).
The most frequent adverse reaction during treatment with epoetin alfa is a dose-dependent increase in blood pressure or aggravation of existing hypertension.
Odrasli in otroci, ki se zdravijo s hemodializo, odrasli bolniki, ki se zdravijo s peritonealno dializo, in odrasli bolniki z ledvično insuficienco, ki se še ne zdravijo z dializo Najpogostejši neželeni učinek, ki se pojavi med zdravljenjem z epoetinom alfa, je od odmerka odvisno zvišanje krvnega tlaka ali poslabšanje obstoječe hipertenzije.
Hypertension may occur in epoetin alfa treated patients.
Odrasli bolniki z rakom in s simptomatsko anemijo, ki se zdravijo s kemoterapijo Pri bolnikih, ki se zdravijo z epoetinom alfa, se lahko pojavi hipertenzija.
An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
Pri bolnikih, ki so prejemali zdravila z eritropoetinom, so opazili zvečano incidenco trombotičnih vaskularnih dogodkov (glejte poglavji 4. 4 in 4. 8 – Splošni).
Independent of erythropoietin treatment, thrombotic and vascular events may occur in surgical patients with underlying cardiovascular disease following repeated phlebotomy.
Kirurški bolniki v programih autologne predominacije Ne glede na zdravljenje z eritropoetinom lahko pri kirurških bolnikih, ki imajo kardiovaskularne bolezni, pri ponovni flebotomiji pride do tromboze in vaskularnih zapletov.
Overdose of erythropoietin may produce effects that are extensions of the pharmacological effects of the hormone.
4. 9 Preveliko odmerjanje
Antianaemic preparations, erythropoietin ATC code:
Druga zdravila za zdravljenje anemije, eritropoetin Oznaka ATC:
The apparent molecular weight of erythropoietin is 32,000-40,000 Dalton.
Navidezna molekularna masa eritropoetina je med 32. 000 in 40. 000 Daltoni.
The protein moiety of the molecule contributes about 58% of total molecular weight and consists of 165 amino acids.
11 prispeva okoli 58% h končni molekularni masi, sestavlja pa ga 165 amino kislin.
The four carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the protein.
Štiri ogljikovodikove verige so s tremi N- glikozidnimi vezmi in eno O- glikozidno vezjo pritrjene na protein.
It could be shown with the aid of cell cultures of human bone marrow cells that erythropoietin stimulates erythropoiesis specifically and does not affect leucopoiesis.
In vitro (celična kultura mišje vranice) so ugotovili povečan obseg vgrajevanja 3H- timidina v eritroidne vranične celice z jedrom po inkubaciji z eritropoetinom. V raziskavah na celičnih kulturah človeškega kostnega mozga so ugotovili, da eritropoetin specifično stimulira eritropoezo in da na levkopoezo ne vpliva.
721 cancer patients receiving non-platinum chemotherapy were included in three placebo-controlled studies, 389 patients with haematological malignancies (221 multiple myeloma, 144 non-Hodgkin's lymphoma, and 24 other haematological malignancies) and 332 with solid tumours (172 breast, 64 gynaecological, 23 lung, 22 prostate, 21 gastrointestinal, and 30 other tumour types).
V treh s placebom kontroliranih študijah je sodelovalo 721 bolnikov z rakom na kemoterapiji brez platine, 389 bolnikov s hematološkimi malignostmi (221 primerov multiplega mieloma, 144 ne - Hodgkinovega limfoma, in 24 primerov drugih hematoloških malignosti) in 332 s čvrstimi tumorji (172 dojke, 64 ginekološki, 23 pljuč, 22 prostate, 21 gastro- intestinalni, in 30 s tumorji drugih vrst).
In two large, open-label studies, 2697 cancer patients receiving non-platinum chemotherapy were included, 1895 with solid tumours (683 breast, 260 lung, 174 gynaecological, 300 gastrointestinal, and 478 other tumour types) and 802 with haematological malignancies.
V dve veliki odprti študiji je bilo vključeno 2. 697 bolnikov z rakom na kemoterapiji brez platine, 1. 895 s čvrstimi tumorji (683 dojke, 260 pljuč, 174 ginekološki, 300 gastrointestinalni, in 478 s tumorji drugih vrst) in 802 s hematološkimi malignimi obolenji.
Functional Assessment of Cancer Therapy-Anaemia (FACT-An) general scale, FACT-An fatigue scale, and Cancer Linear Analogue Scale (CLAS).
V prospektivnem, randomiziranem, dvojno slepem s placebom kontroliranem preskušanju so pri 375 slabokrvnih bolnikih z različnimi nemieloidnimi malignostmi, ki so prejemali kemoterapijo brez platine, ugotovili signifikantno zmanjšanje z anemijo povezanih posledic (npr. utrujenosti, zmanjšane energije in zmanjšane aktivnosti), kot se jih meri s pomočjo naslednjih instrumentov in meril: splošna merila za funkcionalno oceno terapije raka - anemija (FACT- an – ” Functional Assessment of Cancer Therapy- Anaemia ”), FACT- an merila utrujenosti, in linearna analogna skala za rak (CLAS – ” Cancer Linear Analogue Scale ”).
Two other smaller, randomized, placebo-controlled trials failed to show a significant improvement in quality of life parameters on the EORTC-QLQ-C30 scale or CLAS, respectively.
Dva drugi manjši, randomizirani, s placebom kontrolirani preskušanji nista ugotovila signifikantnega napredka v parametrih kvalitete življenja, merjenih s skalama EORTC- QLQ- C30 oziroma CLAS.
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 in napredovanje tumorjev so raziskovali v petih velikih kontroliranih študijah, v katere je bilo vključenih vsega skupaj 2. 833 bolnikov, od katerih so bile štiri študije dvojno slepe in nadzorovane s placebom, ena pa je bila študija odprtega tipa.
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 je bila v dveh študijah > 13 g/ dl, v preostalih treh študijah pa od 12 do 14 g/ dl.
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, s placebom nadzorovanih, študijah so bila razmerja tveganj za skupno preživetje v razponu od 1, 25 in 2, 47 v prid kontrolam.
11 mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Te študije so pokazale dosledno nepojasnjen statistično pomemben presežek smrtnosti pri bolnikih, katerih anemija je povezana z različnimi običajnimi vrstami raka in ki so za razliko od kontrol prejeli rekombinantni humani eritropoetin.
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
Izvedli so tudi sistemsko ocenjevanje, ki je vključevalo več kot 9. 000 bolnikov z rakom, ki so sodelovali v 57 kliničnih preskušanjih.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
12 točke razmerja tveganja, ki je bila 1, 08 v prid kontrolam (95% CI:
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
Povečano relativno tveganje za tromboembolične dogodke (RR 1, 67, 95% CI:
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 6. 769 bolnikov) so opazili pri bolnikih, ki so jih zdravili z rekombinantnim humanim eritropoetinom.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
Obseg, v katerem ti izidi veljajo tudi za dajanje rekombinantnega humanega eritropoetina bolnikom z rakom, ki sočasno prejemajo tudi kemoterapijo, z namenom doseganja koncentracije hemoglobina pod 13 g/ dl, ni znan, ker je bilo v podatke za ocenjevanje vključenih premalo takih bolnikov.
Intravenous route Measurement of erythropoietin following multiple dose intravenous administration revealed a half-life of approximately 4 hours in healthy volunteers and a somewhat more prolonged half-life of approximately 5 hours in renal failure patients.
Intravensko dajanja Pri zdravih prostovoljcih so za eritropoetin, apliciran intravensko v večkratnih odmerkih, izmerili razpolovni čas okoli 4 ur, pri bolnikih z odpovedjo ledvic pa malce daljši razpolovni čas dolžine približno 5 ur.
Subcutaneous route Following subcutaneous injection, serum levels of erythropoietin are much lower than the levels achieved following intravenous injection, the levels increase slowly and reach a peak between 12 and 18 hours postdose.
Subkutano dajanja Po subkutani injekciji so koncentracije eritropoetina v serumu veliko nižje kot pa je to primer pri intravenskih injekcijah. koncentracije počasi rastejo in dosežejo vrh med 12 in 18 urami po odmerjanju.
The peak is always well below the peak achieved using the intravenous route (approximately 1/ 20th of the value).
Vrh je vedno bistveno niže kot v primeru intravenskega dajanja (približno 1/ 20 te vrednosti).
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine Threonine Glutamic acid Phenylalanine Water for injections Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)
13 Kalcijev klorid dihidrat Polisorbat 20 Glicin Levcin Izolevcin Treonin Glutamatna kislina Fenilalanin Voda za injekcije Natrijev hidroksid (za prilagoditev pH) Klorovodikova kislina (za prilagoditev pH)
Keep the pre-filled syringe in the outer carton in order to protect from light.
Pri ambulantni uporabi lahko bolnik zdravilo vzame iz hladilnika in ga nato hrani pri sobni temperaturi (do 25 ºC), vendar največ 3 dni.
For the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 3 days.
Napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Napolnjena brizga iz stekla tipa I s fiksno jekleno iglo in zamaškom s teflonsko prevleko.
Each pre-filled syringe contains 0.3 ml solution for injection.
Vsaka napolnjena brizga vsebuje 0, 3 ml raztopine za injiciranje.
Retacrit must not be used if • The blister sealing is broken or the blister is damaged in any way. • The liquid is coloured or you can see particles floating in it. • Any liquid has leaked out of the pre-filled syringe or condensation is visible within the sealed blister. • It may have been accidentally frozen.
Zdravila Retacrit se ne sme uporabljati, • če je pečat na ovojnini pretrgan ali če je ovojnina na kakršenkoli način poškodovana • če je tekočina obarvana ali če je videti v njej plavati delce • če je iz vnaprej napolnjene brizge iztekla tekočina ali če je v zavarjenem blistru videti kondenzacijo. • če je bila po nesreči zamrznjena
Any unused product or waste material should be disposed of in accordance with local requirements.
14 Neuporabljeno zdravilo in injekcijske igle je treba odstraniti v skladu z lokalnimi predpisi.
Taurusavenue 19-21 NL-2132 LS HOOFDDORP The Netherlands
Taurusavenue 19- 21 NL- 2132 LS HOOFDDORP Nizozemska
Retacrit 2000 IU/ 0.6ml solution for injection in pre-filled syringe
Retacrit 2. 000 i. e. / 0, 6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
1 pre-filled syringe with 0.6 ml solution for injection contains 2000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
1 napolnjena injekcijska brizga z 0, 6 ml raztopine za injiciranje vsebuje 2. 000 mednarodnih enot (i. e.) epoetina zeta * (rekombinantnega humanega eritropoetina).
Each pre-filled syringe contains 0.30 mg phenylalanine.
Vsaka napolnjena brizga vsebuje 0, 30 mg fenilalanina.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patientsIn patients with chronic renal failure the medicinal product has to be administered intravenously (see section 4.4)
16 − Zdravljenje simptomatske anemije pri odraslih in pediatričnih bolnikih s kronično ledvično odpovedjo Pri bolnikih s kronično odpovedjo ledvic je treba zdravilo dajati intravensko (glejte poglavje 4. 4).
15 The haemoglobin concentration aimed for is between 10 and 12 g/ dl (6.2-7.5 mmol/ l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/ dl (5.9-6.8 mmol/ l).
Ciljna koncentracija hemoglobina je med 10 in 12 g/ dl (6, 2– 7, 5 mmol/ l), razen pri pediatričnih bolnikih, kjer mora biti koncentracija hemoglobina med 9, 5 in 11 g/ dl (5, 9– 6, 8 mmol/ l).
Dose (IU/ kg given 3x week)
17 Odmerek (i. e. / kg 3x na teden)
16 The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/ dl or< 4.25 mmol/l) may require higher maintenance doses than those whose initial haemoglobin is higher > 6.8 g/dl or> 4.25 mmol/l).
Klinični podatki, ki so na razpolago kažejo, da so za bolnike z zelo nizkim začetnim nivojem hemoglobina (< 6, 8 g/ dl ali < 4, 25 mmol/ l) lahko potrebni višji vzdrževalni odmerki kot v primeru manj hude začetne anemije (Hb > 6, 8 g/ dl ali > 4, 25 mmol/ l).
Adult patients with renal insufficiency not yet undergoing dialysis
− Odrasli bolniki z ledvično insuficienco, ki se še ne zdravijo z dializo