FrancophonIA/ELRC3.0 huggingface dataset:
English: - For chronic renal failure patients, iron supplementation (elemental iron 200 to 300 mg/day orally for adults and 100 to 200 mg/day orally for paediatrics) is recommended if serum ferritin levels are below 100 ng/mL.
Croatian: Za bolesnike s kroničnim zatajenjem bubrega preporučuje se nadoknada željeza, (elementarno željezo, 200 do 300 mg/dan peroralno za odrasle i 100 do 200 mg/dan peroralno za pedijatrijske bolesnike) ako su razine feritina u serumu manje od 100 ng/ml.
English: Apply pressure over the injection site with a dry, sterile pad.
Croatian: Pritisnite mjesto primjene injekcije suhim, sterilnim tupferom.
English: 4.3 Contraindications - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: - Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Epoetin alfa should be used with caution in patients with porphyria.
Croatian: Epoetin alfa treba primjenjivati s oprezom u bolesnika s porfirijom.
English: In addition, thrombocythaemia above the normal range has been reported.
Croatian: zabilježena je i trombocitemija iznad normalnog raspona.
English: > 13 g/dL (> 8.1 mmol/L), the possibility that epoetin alfa treatment may be associated with an increased risk of postoperative thrombotic/vascular events cannot be excluded.
Croatian: Štoviše, u bolesnika s početnom vrijednošću hemoglobina > 13 g/dl (> 8,1 mmol/l), ne može se isključiti mogućnost povezanosti liječenja epoetinom alfa s povećanim rizikom od postoperativnih trombotskih/vaskularnih događaja.
English: What Epoetin alfa HEXAL looks like and contents of the pack
Croatian: Kako Epoetin alfa HEXAL izgleda i sadržaj pakiranja
English: Epoetin alfa HEXAL is a sterile but unpreserved product and is for single use only.
Croatian: Epoetin alfa HEXAL je sterilan lijek, ali ne sadrži konzervanse i namijenjen je samo za jednokratnu primjenu.
English: If you develop a serious rash or another of these skin symptoms, stop taking Epoetin alfa HEXAL and contact your doctor or seek medical attention immediately.
Croatian: U slučaju nastanka ozbiljnog osipa ili drugih kožnih simptoma, prestanite uzimati lijek Epoetin alfa HEXAL i odmah se obratite svojem liječniku ili potražite medicinsku pomoć.
English: Pharmacotherapeutic group: other antianaemic preparations, erythropoietin, ATC code: B03XA01.
Croatian: Farmakoterapijska skupina: ostali antianemici, eritropoetin, ATK oznaka: B03XA01 Epoetin alfa HEXAL je biosličan lijek.
English: Adult patients with low- or intermediate-1-risk MDS
Croatian: Odrasli bolesnici s MDS-om niskog ili srednjeg-1 rizika
English: Epoetin alfa HEXAL is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does.
Croatian: Epoetin alfa HEXAL pripada skupini lijekova koji potiču stvaranje crvenih krvnih stanica kao što to čini ljudski protein eritropoetin.
English: * Produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology For the full list of excipients, see section 6.1.
Croatian: * Proizvedeno na stanicama ovarija kineskog hrčka (CHO) tehnologijom rekombinantne DNK.
English: The first evidence of a response to epoetin alfa is an increase in the reticulocyte count within 10 days, followed by increases in the red cell count, haemoglobin and haematocrit, usually within 2 to 6 weeks.
Croatian: Prvi dokaz odgovora na epoetin alfa je porast broja retikulocita unutar 10 dana, praćen porastom broja crvenih krvnih stanica, hemoglobina i hematokrita,
English: • Nose or airway congestion.
Croatian: • Začepljnost nosa ili dišnih puteva
English: Epoetin alfa is a copy of the human protein erythropoietin (ee-rith-roe-po-eh-tin) and acts in the same way.
Croatian: Epoetin alfa je kopija ljudskog proteina eritropoetina i djeluje na isti način.
English: Epoetin alfa HEXAL contains the active substance epoetin alfa, a protein that stimulates the bone marrow to produce more red blood cells which carry haemoglobin (a substance that transports oxygen).
Croatian: Epoetin alfa HEXAL sadrži djelatnu tvar epoetin alfa, protein koji potiče koštanu srž da proizvodi više crvenih krvnih stanica koje sadrže hemoglobin (tvar koja prenosi kisik).
English: Where intravenous access is not readily available Epoetin alfa HEXAL may be administered subcutaneously.
Croatian: Kada intavenski pristup nije lako dostupan, Epoetin alfa HEXAL se može primijeniti supkutano.
English: • Do not attempt to inject yourself unless you have been trained to do so by your doctor or nurse.
Croatian: • Nemojte pokušavati sami sebi dati injekciju ako Vas o tome nisu posebno podučili liječnik ili medicinska sestra.
English: ≤ 2 RBC Units >2 and ≤4 RBC Units >4 RBC Units
Croatian: ≤ 2 jedinice crvenih krvnih stanica > 2 i ≤ 4 jedinice crvenih krvnih stanica > 4 jedinice crvenih krvnih stanica
English: An open-label, parallel-group trial in non-iron deficient adult subjects with a pretreatment haemoglobin of ≥ 10 to ≤ 13 g/dL who were scheduled for major orthopaedic hip or knee surgery compared epoetin alfa 300 IU/kg subcutaneously daily for 10 days prior to surgery, on the day of surgery and for four days after surgery to epoetin alfa 600 IU/kg subcutaneously once weekly for 3 weeks prior to surgery and on the day of surgery.
Croatian: U otvorenom ispitivanju na usporedbnim skupinama odraslih ispitanika koji nemaju nedostatak željeza s razinom hemoglobina prije početka liječenja od > 10 do ≤ 13 g/dl predviđenih za veliki elektivni ortopedski kirurški zahvat na kuku ili koljenu uspoređena je primjena 300 IU/kg epoetina alfa na dan supkutano tijekom 10 dana prije operacije, na dan operacije i još 4 dana nakon operacije s primjenom 600 IU/kg epoetina alfa supkutano jednom tjedno, 3 tjedna prije operacije i na dan operacije.
English: The half-life of epoetin alfa following multiple dose intravenous administration is approximately 4 hours in healthy subjects.
Croatian: Poluvijek epoetina alfa nakon intravenske primjene višekratne doze je približno 4 sata u zdravih ispitanika.
English: If you are receiving haemodialysis:
Croatian: Ako ste na hemodijalizi:
English: Other medicines and Epoetin alfa HEXAL
Croatian: Drugi lijekovi i Epoetin alfa HEXAL
English: Two other smaller, randomised, placebo-controlled trials failed to show a significant improvement in quality of life parameters on the EORTC-QLQ-C30 scale or CLAS, respectively.
Croatian: Druga dva manja, randomizirana, placebom kontrolirana ispitivanja nisu uspjela pokazati značajno poboljšanje parametara kvalitete života na ljestvici
English: This is characterised by a sustained decrease in haemoglobin despite an increase in epoetin alfa dosage (see section 4.8).
Croatian: To je karakterizirano nepekidnim sniženjem hemoglobina, usprkos povećanju doze epoetina alfa (vidjeti dio
English: Epoetin alfa HEXAL 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: Epoetin alfa HEXAL se primjenjuje u odraslih osoba s umjerenom anemijom kojima predstoji veliki ortopedski kirurški zahvat (na primjer, operacija zamjene kuka ili koljena), radi smanjivanja moguće potrebe za transfuzijama krvi.
English: Mildly anaemic patients (haematocrit of 33 to 39%) requiring predeposit of ≥ 4 units of blood should be treated with Epoetin alfa HEXAL 600 IU/kg intravenously, 2 times per week for 3 weeks prior to surgery.
Croatian: Liječenje odraslih kirurških bolesnika u programu autologne predonacije Blago anemične bolesnike (hematokrit od 33 do 39%) koji moraju pohraniti ≥ 4 jedinice krvi treba liječiti s 600 IU/kg Epoetin alfa HEXALa intravenski 2 puta tjedno tijekom 3 tjedna prije operacije.
English: Baseline Characteristics for Subjects with sEPO < 200 mU/mL at Screening
Croatian: Početne karakteristike za ispitanike sa sEPO < 200 mU/ml pri probiru
English: Epoetin alfa HEXAL should be administered as a subcutaneous injection.
Croatian: Epoetin alfa HEXAL treba primijeniti kao supkutanu injekciju.
English: • the liquid is coloured or you can see particles floating in it,
Croatian: • je tekućina obojena ili se u njoj vide plutajuće čestice,
English: Occlusion of the dialysis system is possible if heparinisation is not optimum.
Croatian: Ako heparinizacija nije optimalna, moguća je okluzija sustava za dijalizu.
English: In chronic renal failure patients 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 minimise risks of an increase in hypertension.
Croatian: U bolesnika s kroničnim zatajenjem bubrega brzina porasta hemoglobina treba iznositi približno 1 g/dl (0,62 mmol/l) na mjesec i ne smije biti veća od 2 g/dl (1,25 mmol/l) na mjesec, kako bi se minimalizirali rizici od povišenja hipertenzije.
English: Epoetin alfa should be used with caution in patients with epilepsy, history of seizures, or medical conditions associated with a predisposition to seizure activity such as CNS infections and brain metastases.
Croatian: Epoetin alfa treba primijeniti s oprezom u bolesnika s epilepsijom, napadajima u anamnezi ili zdravstvenim stanjima povezanima s predispozicijom za napadaje, kao što su infekcije SŽS-a i metastaze u mozgu.
English: • If you are on a more extended dosing interval (greater than once weekly) of Epoetin alfa HEXAL, you may not maintain adequate haemoglobin levels and you may require an increase in Epoetin alfa HEXAL dose or frequency of administration.
Croatian: • Ako ste na duljem intervalu doziranja (duljem od jedanput tjedno) Epoetin alfa HEXALa možda nećete moći održati odgovarajuće razine hemoglobina i možda će Vam biti potrebno povisiti dozu ili učestalost primjene Epoetin alfa HEXALa.
English: Adult peritoneal dialysis patients
Croatian: Odrasli bolesnici na peritonealnoj dijalizi
English: In these trials, epoetin alfa administered 3 times per week and once weekly has been shown to increase haemoglobin and decrease transfusion requirements after the first month of therapy in anaemic cancer patients.
Croatian: U ovim ispitivanjima dokazano je da primjena epoetina alfa 3 puta tjedno ili jednom tjedno povećava razinu hemoglobina i smanjuje potrebe za transfuzijom nakon prvog mjeseca terapije u anemičnih onkoloških bolesnika.
English: - decreased locoregional control in patients with advanced head and neck cancer receiving radiation therapy when administered to achieve a haemoglobin concentration level of greater than 14 g/dL (8.7 mmol/L),
Croatian: - smanjena lokoregionalna kontrola u bolesnika s uznapredovalim rakom glave i vrata koji su bili liječeni zračenjem, kada se primjenjivao s ciljem postizanja vrijednosti koncentracije hemoglobina veće od 14 g/dl (8,7 mmol/l),
English: In chronic renal failure patients, the half-life of intravenously administered epoetin alfa is slightly prolonged, approximately 5 hours, compared to healthy subjects.
Croatian: U bolesnika s kroničnim zatajenjem bubrega, poluvijek intravenski primijenjenog epoetina alfa blago je produljen, približno 5 sati, u usporedbi sa zdravim ispitanicima.
English: The safety and efficacy of epoetin alfa in paediatric patients receiving chemotherapy have not been established (see section 5.1).
Croatian: Liječenje pedijatrijskih bolesnika s anemijom induciranom kemoterapijom Sigurnost i djelotvornost epoetina alfa u pedijatrijskih bolesnika na kemoterapiji nisu ustanovljene (vidjeti dio 5.1).
English: • Before use, leave the Epoetin alfa HEXAL syringe to stand until it reaches room temperature.
Croatian: • Prije primjene, ostavite štrcaljku Epoetin alfa HEXALa izvan hladnjaka dok ne postigne sobnu temperaturu.
English: No other ESA therapy should be commenced because of the risk of cross-reaction.
Croatian: Ne smije se započeti terapija niti jednim drugim lijekom za stimulaciju eritropoeze zbog rizika od ukrižene reakcije.
English: Epoetin alfa HEXAL is prescribed to stimulate your bone marrow to produce more red blood cells.
Croatian: Epoetin alfa HEXAL se propisuje za poticanje koštane srži na stvaranje više crvenih krvnih stanica.
English: Syringes are embossed with graduation rings in order to enable partial use if required.
Croatian: Na štrcaljkama su otisnuti prstenovi s mjernim oznakama kako bi se omogućila primjena samo jednog dijela lijeka, ako je to potrebno.
English: In cases where there is a medical need to shorten the lead time before surgery to less than three weeks, Epoetin alfa HEXAL 300 IU/kg should be administered subcutaneously daily for 10 consecutive days prior to surgery, on the day of surgery and for four days immediately thereafter.
Croatian: U slučajevima u kojima je iz medicinskih razloga potrebno skratiti razdoblje do kirurškog zahvata na manje od tri tjedna, treba supkutano primijeniti 300 IU/kg Epoetin alfa HEXALa dnevno tijekom 10 uzastopnih dana prije kirurškog zahvata, na sam dan kirurškog zahvata i tijekom četiri dana nakon kirurškog zahvata.
English: Epoetin alfa should be used with caution in patients with chronic liver failure.
Croatian: Epoetin alfa treba primijeniti s oprezom u bolesnika s kroničnim zatajenjem jetre.
English: Discard any unused product or waste material.
Croatian: Bacite neiskorišteni lijek ili otpadni materijal.
English: Epoetin alfa exhibits a dose-related effect on haematological parameters which is independent of route of administration.
Croatian: Farmakokinetički/farmakodinamički odnosi Epoetin alfa pokazuje učinak na hematološke parametre ovisan o dozi, a neovisan o putu primjene.
English: Epoetin alfa HEXAL is used to treat anaemia in adults with a bone marrow disorder that causes a severe disruption in the creation of blood cells (myelodysplastic syndromes).
Croatian: Epoetin alfa HEXAL se primjenjuje za liječenje anemije u odraslih osoba s poremećajem koštane srži koji uzrokuje teške poremećaje u stvaranju krvnih stanica (mijelodisplastični sindromi).
English: Pre-filled syringes*
Croatian: Napunjene štrcaljke*
English: If an elevated or rising serum potassium level is detected, then in addition to appropriate treatment of the hyperkalaemia, consideration should be given to ceasing epoetin alfa administration until the serum potassium level has been corrected.
Croatian: Ako se otkrije da je razina kalija u serumu povišena ili da raste, tada uz odgovarajuće liječenje hiperkalemije treba razmotriti prekid primjene epoetina alfa sve dok se ne korigira razina kalija u serumu.
English: Median time from baseline to first transfusion was statistically significantly longer in the epoetin alfa group compared to placebo (49 vs. 37 days; p = 0.046).
Croatian: Medijan vremena od početka liječenja do prve transfuzije statistički je bilo značajno dulje u skupini liječenoj epoetinom alfa u usporedbi sa skupinom koja je primala placebo (49 u odnosu na 37 dana;
English: A slower administration is preferable in patients who react to the treatment with “flu-like” symptoms (see section 4.8).
Croatian: U bolesnika koji na liječenje reagiraju simptomima „nalik gripi” preferira se sporija primjena (vidjeti dio 4.8).
English: • Bone or muscle pain.
Croatian: • Bolovi u kostima ili mišićima
English: Your doctor will decide how Epoetin alfa HEXAL will be injected.
Croatian: Liječnik će odlučiti kako će se davati injekcija Epoetin alfa HEXAL.
English: The use of epoetin alfa is not recommended in pregnant surgical patients participating in an autologous blood predonation programme.
Croatian: Primjena epoetina alfa se ne preporučuje u trudnih kirurških bolesnica koje sudjeluju u programu predonacije autologne krvi.
English: In the double-blind study, patients were treated with epoetin alfa 600 IU/kg or placebo intravenously once daily every 3 to 4 days over 3 weeks (total 6 doses).
Croatian: U dvostruko slijepom ispitivanju, bolesnici su liječeni sa 600 IU/kg epoetina alfa ili placebom intravenski jednom dnevno svaka 3 do 4 dana tijekom 3 tjedna (ukupno 6 doza).
English: Dose hold and decrease: Epoetin alfa should be withheld when the haemoglobin concentration exceeds 12 g/dL (7.5 mmol/L).
Croatian: Zadržavanje i smanjenje doze: primjenu epoetina alfa treba se obustaviti kada koncentracija hemoglobina prekorači 12 g/dl (7,5 mmol/l).
English: Epoetin alfa is not approved in the management of anaemia associated with hepatitis C.
Croatian: Epoetin alfa nije odobren za liječenje anemije povezane s hepatitisom C.
English: Epoetin alfa HEXAL is used to treat anaemia in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma (bone marrow cancer) who may have a need for a blood transfusion.
Croatian: Epoetin alfa HEXAL se primjenjuje za liječenje anemije u odraslih koji primaju kemoterapiju zbog solidnog tumora, zloćudnog limfoma ili multiplog mijeloma (rak koštane srži) i kod kojih bi mogla postojati potreba za transfuzijom krvi.
English: • If you are having dialysis treatment when you begin treatment with Epoetin alfa HEXAL, your dialysis regime may need to be adjusted.
Croatian: • Ako u vrijeme početka liječenja Epoetin alfa HEXALom idete na dijalizu, možda će biti potrebno prilagoditi raspored dijalize.
English: Side effects from an overdose of Epoetin alfa HEXAL are unlikely.
Croatian: Nuspojave zbog predoziranja Epoetin alfa HEXALom su malo vjerojatne.
English: The needle safety guard covers the needle after injection to prevent needle stick injury.
Croatian: Primjena napunjene štrcaljke sa sigurnosnim štitnikom za iglu Sigurnosni štitnik za iglu prekriva iglu nakon davanja injekcije, radi sprječavanja ubodne ozljede iglom.
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 jest zadržati razine hemoglobina između 10 i 12 g/dl jer veće razine hemoglobina mogu povećati rizik za stvaranje krvnih ugrušaka i smrt.
English: Epoetin alfa HEXAL is presented as a clear, colourless solution for injection in a pre-filled syringe.
Croatian: Epoetin alfa HEXAL je dostupan u obliku bistre, bezbojne otopine za injekciju u napunjenoj štrcaljki.
English: Epoetin alfa has been shown to stimulate erythropoiesis in anaemic patients with CRF, including dialysis and pre-dialysis patients.
Croatian: Dokazano je da epoetin alfa stimulira eritropoezu u anemičnih bolesnika s KZB, uključujući bolesnike na dijalizi i one koji još nisu na dijalizi.
English: • The usual dose is 600 IU per kilogram body weight twice a week.
Croatian: • Uobičajena doza je 600 IU po kilogramu tjelesne težine dva puta tjedno.
English: While on Epoetin alfa HEXAL, some people need medicines to reduce the risk of blood clots.
Croatian: Nekim su osobama za vrijeme primanja Epoetin alfa HEXALa potrebni lijekovi koji smanjuju rizik od krvnih ugrušaka.
English: Due to intra-patient variability, occasional individual haemoglobin concentrations for a patient above and below the desired haemoglobin concentration range may be observed.
Croatian: Zbog intraindividualne varijabilnosti među bolesnicima, povremeno se mogu opaziti individualne koncentracije hemoglobina u bolesnika koje su iznad ili ispod željenog raspona koncentracije hemoglobina.
English: If after an additional 4 weeks of therapy at 300 IU/kg 3 times per week, the haemoglobin concentration has increased ≥ 1 g/dL (≥ 0.62 mmol/L) or the reticulocyte count has increased ≥ 40,000 cells/µL, the dose should remain at 300 IU/kg 3 times per week.
Croatian: Ako se nakon dodatna 4 tjedna terapije dozom od 300 IU/kg 3 puta tjedno koncentracija hemoglobina povećala za ≥ 1 g/dl (≥ 0,62 mmol/l) ili se broj retikulocita povećao za ≥ 40 000 stanica/µl, dozu treba zadržati na 300 IU/kg 3 puta tjedno.
English: If the haemoglobin level reaches 15 g/dL (9.38 mmol/L), or higher, during the preoperative period, administration of Epoetin alfa HEXAL should be stopped and further dosages should not be administered.
Croatian: Ako tijekom predoperacijskog razdoblja razina hemoglobina postigne vrijednost od 15 g/dl (9,38 mmol/l) ili više, primjenu Epoetin alfa HEXALa treba prekinuti i više ne treba primijeniti dodatne doze.
English: Epoetin alfa HEXAL is not approved in the management of anaemia associated with hepatitis C.
Croatian: Epoetin alfa HEXAL nije odobren za liječenje anemije povezane s hepatitisom C.
English: Epoetin alfa administered 3 times per week or once weekly has been shown to increase haemoglobin and decrease transfusion requirements after the first month of therapy in anaemic cancer patients receiving chemotherapy.
Croatian: Dokazano je da primjena epoetina alpha 3 puta tjedno ili jednom tjedno povećava razinu hemoglobina i smanjuje potrebe za transfuzijom u anemičnih bolesnika s rakom koji primaju kemoterapiju nakon prvog mjeseca terapije.
English: Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin concentration range may be observed.
Croatian: Zbog intraindividualne varijabilnosti među bolesnicima, povremeno se mogu opaziti individualne vrijednosti hemoglobina koje su iznad ili ispod željenog raspona koncentracije hemoglobina.
English: A sustained haemoglobin concentration of greater than 12 g/dL (7.5 mmol/L) should be avoided; guidance for appropriate dose adjustment for when haemoglobin concentrations exceed 12 g/dL (7.5 mmol/L) is described below.
Croatian: Održavanje koncentracije hemoglobina iznad 12 g/dl (7,5 mmol/l) treba izbjegavati; smjernice za odgovarajuću prilagodbu doze kada koncentracije hemoglobina prelaze 12 g/dl (7,5 mmol/l) opisane su u nastavku.
English: Therefore, epoetin alfa should not be used in patients with baseline haemoglobin > 13 g/dL (> 8.1 mmol/L).
Croatian: Zbog toga se epoetin alfa ne smije primjenjivati u bolesnika s početnom vrijednošću hemoglobina > 13 g/dl (> 8,1 mmol/l).
English: Median overall survival in the epoetin alfa plus SOC group was 17.8 months compared with 18.0 months in the SOC alone group (HR 1.07, 95% CI: 0.97, 1.18).
Croatian: Medijan ukupnog preživljenja u skupini liječenoj epoetinom alfa plus standardna terapija bio je 17,8 mjeseci u usporedbi sa 18,0 mjeseci u skupini liječenoj samo standardnom terapijom (HR 1,07, 95 % CI: 0,97; 1,18).
English: If necessary, increase or decrease the dose by 25 IU/kg (3 times per week) until the desired haemoglobin concentration range of between 9.5 g/dL to 11 g/dL (5.9 to 6.8 mmol/L) is achieved (this should be done in steps of at least four weeks).
Croatian: Ako je potrebno, doza se može povećati ili smanjiti za 25 IU/kg (3 puta tjedno) dok se ne postigne željeni raspon koncentracije hemoglobina između 9,5 g/dl i 11 g/dl (5,9 i 6,8 mmol/l) (to treba učiniti u razmacima od najmanje četiri tjedna).
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 podijeljeni u 2 skupine: u jednoj je terapija epoetinom alfa bila usmjerena na održavanje razine hemoglobina od 13,5 g/dl (više od preporučene razine koncentracije hemoglobina), a u drugoj 11,3 g/dl.
English: - shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to achieve a haemoglobin concentration range of 12 to 14 g/dL (7.5 to 8.7 mmol/L),
Croatian: - skraćeno ukupno preživljenje i povećan broj smrtnih slučajeva koji su se mogli pripisati napredovanju bolesti nakon 4 mjeseca u bolesnica s metastatskim rakom dojke koje su primale kemoterapiju, kada se primjenjivao s ciljem postizanja raspona koncentracije hemoglobina od 12 do 14 g/dl (7,5-8,7 mmol/l),
English: ESAs are not indicated for use in this patient population,
Croatian: Lijekovi za stimulaciju eritropoeze nisu indicirani za primjenu u ovoj populaciji bolesnika,
English: Pure Red Cell Aplasia (PRCA)
Croatian: Izolirana aplazija crvene loze (engl.
English: • Symptoms of pure red cell aplasia (PRCA)
Croatian: • Simptomi izolirane aplazije crvene loze (engl.
English: The therapeutic margin of epoetin alfa is very wide.
Croatian: Epoetin alfa ima vrlo veliku terapijsku širinu.