FrancophonIA/ELRC3.0 huggingface dataset:
English: Epoetin alfa was administered subcutaneously for 10 days prior to surgery, on the day of surgery, and for four days after surgery.
Croatian: Epoetin alfa primali su supkutano 10 dana prije kirurškog zahvata, na dan zahvata i još 4 dana nakon toga.
English: Based on information available to date, correction of anaemia with epoetin zeta in adult patients with renal insufficiency not yet undergoing dialysis does not accelerate the rate of progression of renal insufficiency.
Croatian: Na temelju dosad dostupnih podataka, korekcija anemije primjenom epoetina zeta u odraslih bolesnika s insuficijencijom bubrega koji još nisu podvrgnuti dijalizi ne ubrzava napredovanje insuficijencije bubrega.
English: •Retacrit is used in moderatelyanaemic adults who donate some of their blood before surgery, so that it can be given back to them during or after the operation.
Croatian: • Retacrit se koristi u umjereno anemičnih bolesnika koji će daju krv prije kirurškog zahvata, kako bi im se ona mogla transfuzijom vratiti tijekom ili nakon operacije.
English: Patients treated with epoetin alfa were also able to predeposit significantly more units of blood (epoetin alfa 300 IU/kg = 4.4 units; epoetin alfa 600 IU/kg = 4.7 units) than placebo-treated patients (2.9 units).
Croatian: Bolesnici liječeni epoetinom alfa mogli su prethodno pohraniti značajno veći broj jedinica krvi (epoetin alfa 300 IU/kg = 4,4 jedinice; epoetin alfa 600 IU/kg = 4,7 jedinica) nego bolesnici koji su primali placebo (2,9 jedinica).
English: On average, patients treated with epoetin alfa were able to predeposit significantly more units of blood (4.5 units) than placebo-treated patients (3.0 units).
Croatian: U prosjeku, bolesnici liječeni epoetinom alfa mogli su prethodno pohraniti značajno veći broj jedinica krvi (4,5 jedinica) nego bolesnici koji su primali placebo (3,0 jedinica).
English: • Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Retacrit treatment.
Croatian: • Liječnik će tražiti da obavite krvne pretrage i može Vam prilagoditi dozu, ovisno o tome kako anemija od koje bolujete reagira na liječenje Retacritom.
English: In order to ensure optimum response to epoetin zeta, adequate iron stores should be assured and iron supplementation should be administered if necessary (see section 4.2):
Croatian: Kako bi se zajamčio optimalan odgovor na epoetin zeta, treba osigurati odgovarajuće zalihe željeza, ako je potrebno, i uvesti nadoknadu željeza (vidjeti dio 4.2):
English: Epoetin alfa has been shown to stimulate red blood cell production in order to augment autologous blood collection, and to limit the decline in haemoglobin in adult patients scheduled for major elective surgery who are not expected to predeposit their complete perioperative blood needs.
Croatian: Pokazalo se da epoetin alfa potiče proizvodnju crvenih krvnih stanica kako bi se povećala količina uzete autologne krvi i ograničava pad hemoglobina u odraslih bolesnika planiranih za veliki elektivni kirurški zahvat za koje se ne očekuje da će prethodno trebati pohraniti količinu krvi potrebnu za cjelokupno perioperacijsko razdoblje.
English: The recommended total weekly dose is between 75 IU/kg and 300 IU/kg.
Croatian: Preporučena ukupna tjedna doza iznosi između 75 IU/kg i 300 IU/kg.
English: Despite differences in concentration-time profiles the pharmacodynamic response (as measured by changes in percent reticulocytes, haemoglobin, and total RBCs) was similar between these regimens.
Croatian: Unatoč razlikama u profilima krivulja koncentracija-vrijeme, farmakodinamički je odgovor (mjeren promjenama postotka retikulocita, hemoglobina i ukupnih crvenih krvnih stanica) bio sličan u oba režima.
English: In children the haemoglobin level should be maintained between 9.5 and 11 g/dL.
Croatian: U djece se razina hemoglobina mora održavati između 9,5 i 11 g/dl.
English: Do not remove the syringe's needle cover while allowing it to reach room temperature.
Croatian: Ne uklanjajte pokrov igle sa štrcaljke dok dopuštate lijeku da postigne sobnu temperaturu.
English: Chronic renal failure patients treated with epoetin zeta by the subcutaneous route should be monitored regularly for loss of efficacy, defined as absent or decreased response to epoetin zeta treatment in patients who previously responded to such therapy.
Croatian: Bolesnike s kroničnim zatajenjem bubrega liječenih supkutanom primijenjenim epoetinom zeta treba redovito pratiti zbog mogućeg gubitka djelotvornosti, definiranog kao izostanak ili smanjenje odgovora na liječenje epoetinom zeta u bolesnika u kojih je prije postojao odgovor na tu terapiju.
English: Retacrit is not approved in the management of anaemia associated with hepatitis C.
Croatian: Retacrit nije odobren za liječenje anemije povezane s hepatitisom C.
English: “Instructions on how to inject Retacrit yourself” can be found at the end of the package leaflet.
Croatian: „Upute za samostalnu primjenu injekcija Retacrita” nalaze se na kraju upute o lijeku.
English: Mildly anaemic patients (haematocrit of 33 to 39%) requiring predeposit of ≥ 4 units of blood should be treated with Retacrit 600 IU/kg intravenously, 2 times per week for 3 weeks prior to surgery.
Croatian: Bolesnike s blažom anemijom (hematokrit od 33 do 39%) kojima se planira uzeti ≥ 4 jedinice krvi potrebno je liječiti Retacritom u dozi od 600 IU/kg, primjenjivanoj intravenski 2 puta tjedno, tijekom 3 tjedna prije operacije.
English: Moreover, epoetin alfa doses of 75 to 150 IU/kg per week have been shown to maintain haematocrits of 36 to 38% for up to six months.
Croatian: Nadalje, pokazalo se da doze epoetina alfa od 75 do 150 IU/kg tjedno održavaju vrijednosti hematokrita između 36 i 38% i do šest mjeseci.
English: Patients were assigned to epoetin alfa treatment targeting a maintenance haemoglobin level of 13.5 g/dL (higher than the recommended haemoglobin concentration level) or 11.3 g/dL.
Croatian: Bolesnici su bili raspoređeni na terapiju epoetinom alfa usmjerenom na održavanje razine hemoglobina od 13,5 g/dl (više od preporučene razine koncentracije hemoglobina) ili od 11,3 g/dl.
English: Because Retacrit stimulates the production of red blood cells, doctors can take more blood from these people.
Croatian: Budući da Retacrit potiče proizvodnju crvenih krvnih stanica, od takvih se osoba može uzeti više krvi.
English: Shunt thrombosis have occurred in haemodialysis patients, especially in those who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e.g. stenoses, aneurysms, etc.).
Croatian: U bolesnika na hemodijalizi razvila se tromboza šanta, a osobito u onih s tendencijom pojave hipotenzije ili u onih s komplikacijama prouzročenim arteriovenskom fistulom (npr. stenoze, aneurizme itd.).
English: Good sites are the top of the thigh and around the tummy (abdomen)
Croatian: Prikladna mjesta su gornji dio bedara, trbuh (abdomen) osim područja oko pupka.
English: Treatment should only be given to patients with moderate anaemia (haemoglobin [Hb] concentration range between 10 to 13 g/dL [6.2 to 8.1 mmol/L], no iron deficiency) if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Croatian: Lijek se smije primijeniti samo u bolesnika s umjerenom anemijom (koncentracija hemoglobina [Hb] u rasponu između 10 i 13 g/dl [od 6,2 do 8,1 mmol/l], bez nedostatka željeza), ako postupci pohrane krvi nisu dostupni ili su nedostatni, kada je za planirani veliki elektivni kirurški zahvat potreban veliki volumen krvi (4 ili više jedinica krvi za žene ili 5 ili više jedinica krvi za muškarce).
English: You can press an antiseptic swab over the injection site for a few seconds after the injection.
Croatian: Nakon injekcije možete pritisnuti aseptičku maramicu na mjesto injiciranja nekoliko sekundi.
English: A randomised, open-label, multicentre study was conducted in 2 098 anaemic women with metastatic breast cancer, who received first line or second line chemotherapy.
Croatian: Randomizirano, otvoreno, multicentrično ispitivanje provedeno je u 2098 anemičnih bolesnica s metastatskim rakom dojke koje su primale prvu ili drugu liniju kemoterapije.
English: Good blood management practices should always be used in the perisurgical setting.
Croatian: U perioperacijskom okruženju treba uvijek treba primjenjivati dobru praksu postupanja s krvlju.
English: The most frequently occurring adverse drug reactions observed in clinical trials of epoetin alfa are diarrhoea, nausea, vomiting, pyrexia and headache.
Croatian: U kliničkim ispitivanjima epoetina alfa, najčešće opažene nuspojave bile su proljev, mučnina, povraćanje, pireksija i glavobolja.
English: Patients should be monitored closely to ensure that the lowest approved effective dose of Retacrit is used to provide adequate control of anaemia and of the symptoms of anaemia whilst maintaining a haemoglobin concentration below or at 12 g/dL (7.5 mmol/L).
Croatian: Bolesnike treba pomno nadzirati kako bi se osigurala primjena najniže odobrene učinkovite doze Retacrita za adekvatnu kontrolu anemije i simptoma anemije, uz istodobno održavanje koncentracije hemoglobina ispod ili na 12 g/dl (7,5 mmol/l).
English: The effect of epoetin alfa in facilitating autologous blood donation in patients with low haematocrits (≤ 39% and no underlying anaemia due to iron deficiency) scheduled for major orthopaedic surgery was evaluated in a double-blind, placebo-controlled study conducted in 204 patients, and a single-blind placebo controlled study in 55 patients.
Croatian: Učinak epoetina alfa u omogućavanju pohrane autologne krvi u bolesnika s niskim vrijednostima hematokrita (≤ 39% i bez podležeće anemije zbog nedostatka željeza) planiranih za veliki ortopedski kirurški zahvat procijenjen je u dvostruko slijepom, placebom kontroliranom ispitivanju provedenom u 204 bolesnika i jednostruko slijepom, placebom kontroliranom ispitivanju u 55 bolesnika.
English: • epileptic seizures or fits
Croatian: • epileptičke napadaje
English: The safety and efficacy of epoetin alfa in paediatrics have not been established.
Croatian: Sigurnost i djelotvornost epoetina alfa u pedijatrijskih bolesnika nisu ustanovljene.
English: The desired haemoglobin concentration range was 9.6 to 11.2 g/dL.
Croatian: Željeni raspon koncentracije hemoglobina bio je od 9,6 do 11,2 g/dl.
English: Only take one dose of Retacrit from each syringe.
Croatian: Iz jedne štrcaljke primijenite samo jednu dozu Retacrita.
English: 4.1 Therapeutic indications
Croatian: Terapijske indikacije
English: The greatest effects are observed in patients with low haemoglobin (≤ 13 g/dL; 8.1 mmol/L).
Croatian: Najveći učinci opaženi su u bolesnika s niskim vrijednostima hemoglobina (≤ 13 g/dl; 8,1 mmol/l).
English: Epoetin alfa 600 IU/kg (administered intravenously or subcutaneously once weekly) has been evaluated in a randomised, double-blind, placebo-controlled, 16-week study and in a randomised, controlled, open-label, 20-week study in anaemic paediatric patients receiving myelosuppressive chemotherapy for the treatment of various childhood non-myeloid malignancies.
Croatian: Primjena epoetina alfa u dozi od 600 IU/kg (intravenski ili supkutano jedanput tjedno) ocijenjena je u randomiziranom, dvostruko slijepom, placebom kontroliranom 16-tjednom ispitivanju i u randomiziranom, kontroliranom, otvorenom 20-tjednom ispitivanju u anemičnih pedijatrijskih bolesnika koji su primali mijelosupresivnu kemoterapiju za liječenje različitih nemijeloičnih malignih bolesti dječje dobi.
English: Starting dose of 50 IU/kg, 3 times per week, followed if necessary by a dosage increase with 25 IU/kg increments (3 times per week) until the desired goal is achieved (this should be done in steps of at least four weeks).
Croatian: Početna doza iznosi 50 IU/kg, 3 puta tjedno, nakon čega, ako je potrebno, slijedi postupno povećavanje doze za 25 IU/kg (3 puta tjedno) dok se ne postigne željeni cilj (to treba provoditi u razmacima od najmanje četiri tjedna).
English: Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dL or 6.2 to 8.1 mmol/L) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1 800 mL).
Croatian: Primjena mora biti ograničena na bolesnike s umjerenom anemijom (npr. koncentracija hemoglobina u rasponu između 10 i 13 g/dl ili 6,2 i 8,1 mmol/l) za koje nije dostupan program autologne predonacije i u kojih se očekuje umjereni gubitak krvi (900 do 1800 ml).
English: Included were 228 epoetin alfa-treated CRF subjects in 4 chronic renal failure studies (2 studies in predialysis [N = 131 exposed CRF subjects] and 2 in dialysis [N = 97 exposed CRF subjects]); 1,404 exposed cancer subjects in 16 studies of anaemia due to chemotherapy; 147 exposed subjects in 2 studies for autologous blood donation; 213 exposed subjects in 1 study in the perisurgical period, and 102 exposed subjects in 2 MDS studies.
Croatian: Uključeno je 228 ispitanika s kroničnim zatajenjem bubrega liječenih epoetinom alfa u 4 ispitivanja kroničnog zatajenja bubrega (2 ispitivanja u bolesnika koji još nisu na dijalizi [N = 131 izloženih ispitanika s kroničnim zatajenjem bubrega] i 2 na dijaliziranima [N = 97 izloženih ispitanika s kroničnim zatajenjem bubrega]; 1404 izloženih ispitanika s malignim bolestima u 16 ispitivanja anemije uslijed kemoterapije; 147 izloženih ispitanika u 2 ispitivanja autologne donacije krvi; 213 izloženih ispitanika u 1 ispitivanju u periodu prije operativnog zahvata i 102 izloženih ispitanika u 2 ispitivanja mijelodisplastičnog sindroma.
English: *Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
Croatian: *Proizveden tehnologijom rekombinantne DNK na staničnoj liniji jajnika kineskog hrčka (engl.
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section
Croatian: Metaanalize također dosljedno ukazuju na značajno povišen relativni rizik od tromboembolijskih događaja u onkoloških bolesnika koji primaju rekombinantni ljudski eritropoetin (vidjeti dio 4.4).
English: If epoetin zeta is given concomitantly with cyclosporin, blood levels of cyclosporin should be monitored and the dose of cyclosporin adjusted as the haematocrit rises.
Croatian: Ako se epoetin zeta daje istodobno s ciklosporinom, potrebno je pratiti razinu ciklosporina u krvi i prilagoditi njegovu dozu prema rastu hematokrita.
English: No data on the effects of epoetin zeta on fertility are available.
Croatian: Nema dostupnih podataka o učincima epoetina zeta na plodnost.
English: The recommended dose is Retacrit 600 IU/kg administered subcutaneously weekly for three weeks (days -21, -14 and -7) prior to surgery and on the day of surgery.
Croatian: Preporučena doza Retacrita iznosi 600 IU/kg, primijenjena supkutano jedanput tjedno tijekom tri tjedna (dani -21., -14. i -7.) prije operacije i na sam dan operacije.
English: Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive Retacrit or any other erythropoietin (see section 4.4).
Croatian: Pure Red Cell Aplasia, PRCA) ne smiju primiti Retacrit niti bilo koji drugi eritropoetin (vidjeti dio 4.4).
English: • Retacrit is used in moderately anaemic adults about to have major orthopaedic surgery (for example hip or knee replacement operations), to reduce the potential need for blood transfusions.
Croatian: • Retacrit se koristi u umjereno anemičnih odraslih prije velikih ortopedskih operacija (npr. operacije zamjene kuka ili koljena), da bi se smanjila moguća potreba za transfuzijom krvi.
English: The recommended starting dose is Retacrit 450 IU/kg (maximum total dose is 40 000 IU) administered subcutaneously once every week, with not less than 5 days between doses.
Croatian: Preporučena početna doza Retacrita iznosi 450 IU/kg (maksimalna ukupna doza iznosi 40 000 IU), primijenjena supkutano jednom tjedno svakog tjedna, s razmakom između doza od najmanje 5 dana.
English: Administration of single doses of 300 to 2 400 IU/kg subcutaneous erythropoietin resulted in a linear relationship between mean Cmax and dose and between mean AUC and dose.
Croatian: Primjena jednokratnih doza od 300 IU/kg do 2400 IU/kg eritropoetina supkutano pokazala je linearni odnos između srednje vrijednosti Cmax i doze te srednje vrijednosti AUC-a i doze.
English: In clinical trials conducted in patients with CRF not on dialysis treated with epoetin alfa, the average duration of therapy was nearly five months.
Croatian: U kliničkim ispitivanjima provedenima u bolesnika s kroničnim zatajenjem bubrega koji nisu na dijalizi a liječeni su epoetinom alfa, prosječno trajanje terapije bilo je gotovo pet mjeseci.
English: Retacrit is prescribed to stimulate your bone marrow to produce more red blood cells.
Croatian: Retacrit se propisuje za poticanje koštane srži da proizvede više crvenih krvnih stanica.
English: A major cardiovascular event (death, myocardial infarction, stroke or hospitalization for congestive heart failure) occurred among 125 (18%) of the 715 patients in the higher haemoglobin group compared to 97 (14%) among the 717 patients in the lower haemoglobin group (hazard ratio [HR] 1.3, 95% CI: 1.0, 1.7, p = 0.03).
Croatian: Veliki kardiovaskularni događaj (smrt, infarkt miokarda, moždani udar ili hospitalizacija zbog kongestivnog zatajenja srca) razvio se u 125 (18%) od 715 bolesnika u skupini s višom razinom hemoglobina u usporedbi s 97 (14%) od 717 bolesnika u skupini s nižom razinom hemoglobina (omjer hazarda [HR] 1,3; 95% CI: 1,0; 1,7; p = 0,03).
English: This was a non inferiority study designed to rule out a 15% risk increase in tumour progression or death of epoetin alfa plus standard of care (SOC) as compared with SOC alone.
Croatian: To je bilo ispitivanje neinferiornosti ustrojeno tako da se isključi 15%-tno povećanje rizika od progresije tumora ili smrti pri liječenju epoetinom alfa i standardnom terapijom u usporedbi sa samo standardnom terapijom.
English: Each pack contains 1 or 6 pre-filled syringes.
Croatian: Svako pakiranje sadrži 1 ili 6 napunjenih štrcaljki.
English: The most frequent adverse drug reaction during treatment with epoetin alfa is a dose-dependent increase in blood pressure or aggravation of existing hypertension.
Croatian: Tijekom liječenja epoetinom alfa najčešća je nuspojava porast krvnog tlaka ovisan o dozi ili pogoršanje postojeće hipertenzije.
English: The solution contains 3 333 IU epoetin zeta per ml.
Croatian: Otopina sadrži 3333 IU epoetina zeta po ml.
English: Prolonged vigorous shaking may damage the product.
Croatian: Dulje snažno protresanje može oštetiti lijek.
English: Respiratory tract congestion, which includes events of upper respiratory tract congestion, nasal congestion and nasopharyngitis, have been reported in studies with extended interval dosing in adult patients with renal insufficiency not yet undergoing dialysis.
Croatian: Kongestija dišnih putova, koja uključuje kongestiju gornjeg dijela dišnih putova, nosnu kongestiju i nazofaringitis, bila je prijavljena u ispitivanjima s produljenim intervalom doziranja u odraslih bolesnika s insuficijencijom bubrega koji još nisu na dijalizi.
English: In addition, special precaution should be taken in patients with predisposition for development of DVTs.
Croatian: Osim toga, potrebno je poduzeti posebne mjere opreza u bolesnika s predispozicijom za razvoj duboke venske tromboze (DVT).
English: The aim of treatment is to maintain your haemoglobin level between 10 and 12 g/dL as a higher haemoglobin level may increase the risk of blood clots and death.
Croatian: Cilj liječenja je održati razinu hemoglobina između 10 i 12 g/dl jer viša razina hemoglobina može povećati rizik od stvaranja krvnih ugrušaka i smrti.
English: If the patient loses response or haemoglobin concentration drops by ≥1 g/dL upon dose reduction the dose should be increased by one dosing step.
Croatian: Ako u bolesnika dođe do gubitka odgovora ili se prilikom smanjenja doze koncentracija hemoglobina smanji za ≥ 1 g/dl, dozu je potrebno povećati za jedan dozni korak.
English: Where intravenous access is not readily available Retacrit may be administered subcutaneously.
Croatian: Kada intravenski pristup nije lako dostupan, Retacrit se može primijeniti supkutano.
English: Patients were stratified according to their baseline haemoglobin (≤ 10 g/dL, >10 to ≤ 13 g/dL and >13 g/dL).
Croatian: Bolesnici su bili stratificirani prema početnoj vrijednosti hemoglobina (≤ 10 g/dl, > 10 do ≤ 13 g/dl i > 13 g/dl).
English: When treatment starts, Retacrit is usually injected by medical professional or a nurse.
Croatian: Na početku liječenja Retacrit će Vam obično davati zdravstveni radnik ili medicinska sestra.
English: In a double-blind, placebo-controlled, multicentre, quality of life study in CRF patients on haemodialysis, clinically and statistically significant improvement was shown in the patients treated with epoetin alfa compared to the placebo group when measuring fatigue, physical symptoms, relationships and depression (Kidney Disease Questionnaire) after six months of therapy.
Croatian: U dvostruko slijepom, placebom kontroliranom, multicentričnom ispitivanju kvalitete života u bolesnika s kroničnim zatajenjem bubrega na hemodijalizi, dokazano je klinički i statistički značajno poboljšanje u bolesnika liječenih epoetinom alfa u usporedbi sa skupinom koja je primala placebo kada su nakon šest mjeseci terapije mjereni umor, tjelesni simptomi, odnosi s drugima i depresija (upitnikom za bolesnike s bubrežnim bolestima).
English: Of a total 3 417 subjects in 25 randomised, double-blinded, placebo or standard of care controlled studies, the overall safety profile of epoetin alfa was evaluated in 2 094 anaemic subjects.
Croatian: Od ukupno 3417 ispitanika iz 25 randomiziranih, dvostruko slijepih, placebom ili standardnom terapijom kontroliranih kliničkih ispitivanja, ukupan sigurnosni profil epoetina alfa procijenjen je u 2094 ispitanika s anemijom.
English: The maximum dosage should not exceed 150 IU/kg 3 times per week, 240 IU/kg (up to a maximum of 20 000 IU) once weekly, or 480 IU/kg (up to a maximum of 40 000 IU) once every 2 weeks.
Croatian: Maksimalna doza ne smije biti veća od 150 IU/kg primijenjenih 3 puta tjedno, 240 IU/kg (do najviše 20 000 IU) primijenjenih jednom tjedno ili 480 IU/kg (do najviše 40 000 IU) primijenjenih jednom u svaka 2 tjedna.
English: In order to ensure optimum response to epoetin zeta, adequate iron stores should be assured and iron supplementation should be administered if necessary (see section 4.4).
Croatian: Da bi se osigurao optimalan odgovor na epoetin zeta, potrebno je osigurati odgovarajuće zalihe željeza te, ako je potrebno, uvesti nadoknadu željeza (vidjeti dio 4.4).
English: Epoetin zeta is a copy of the human protein erythropoietin (ee-rith-roe-po-eh-tin) and acts in the same way.
Croatian: Epoetin zeta je kopija ljudskog proteina eritropoetina i djeluje na isti način.
English: • If there is a medical need to reduce the time before your operation, you will be given a daily dose of 300 IU/kg for up to ten days before surgery, on the day of surgery and for four days immediately afterwards.
Croatian: • Ako Vam je zbog medicinskih razloga potrebno skratiti vrijeme prije operacije, primat ćete dnevnu dozu od 300 IU/kg do deset dana prije operacije, na dan operacije i još četiri dana neposredno nakon operacije.
English: In patients with a poor haemoglobin response to ESA, alternative explanations for the poor response should be considered (see sections 4.4 and 5.1).
Croatian: U bolesnika sa slabim odgovorom hemoglobina na ESA lijek potrebno je razmotriti druga moguća objašnjenja za slabi odgovor (vidjeti dijelove 4.4 i 5.1).
English: • in severely anaemic adults not yet undergoing dialysis.
Croatian: • u odraslih s teškom anemijom koji još nisu na dijalizi.