FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of bone marrow fibrosis was not increased in a study of haemodialysis patients who were treated with epoetin alfa for 3 years compared to a matched control group of dialysis patients who had not been treated with epoetin alfa.
Slovenian: Študija pri bolnikih na hemodializi, ki so se 3 leta zdravili z epoetinom alfa, ni pokazala večje incidence fibroze kostnega mozga v primerjavi z enako kontrolno skupino bolnikov na dializi, ki se niso zdravili z epoetinom alfa.
English: 1,000 IU/0.5 mL 2,000 IU/1 mL
Slovenian: 1.000 i.e./0,5 ml 2.000 i.e./1 ml
English: • Epoetin alfa HEXAL is given by injection under the skin.
Slovenian: • Zdravilo Epoetin alfa HEXAL se daje v obliki injekcije pod kožo.
English: Epoetin alfa HEXAL is used in moderately anaemic adults who donate some of their blood before surgery, so that it can be given back to them during or after the operation.
Slovenian: Zdravilo Epoetin alfa HEXAL se uporablja za zdravljenje zmerno anemičnih odraslih, ki pred kirurškim posegom darujejo nekaj svoje krvi, da jo lahko med kirurškim posegom ali po njem dobijo nazaj.
English: • Flu-like symptoms, such as headache, aches and pains in the joints, feeling of weakness, chills, tiredness and dizziness.
Slovenian: • Gripi podobni simptomi kot so glavobol, bolečine sklepov, občutek šibkosti, mrzlica,
English: The safety and efficacy of epoetin alfa in paediatric patients receiving chemotherapy have not been established (see section 5.1).
Slovenian: Zdravljenje pediatričnih bolnikov z anemijo, ki je posledica kemoterapije Varnost in učinkovitost epoetina alfa pri pediatričnih bolnikih, ki prejemajo kemoterapijo, nista bili dokazani (glejte poglavje 5.1).
English: Uncommon side effects These may affect up to 1 in 100 people.
Slovenian: Občasni neželeni učinki Pojavijo se lahko pri največ 1 od 100 bolnikov
English: Epoetin alfa HEXAL is a biosimilar medicinal product.
Slovenian: Zdravilo Epoetin alfa HEXAL je podobno biološko zdravilo.
English: 20,000 IU/0.5 mL 30,000 IU/0.75 mL 40,000 IU/1 mL
Slovenian: 20.000 i.e./0,5 ml 30.000 i.e./0,75 ml 40.000 i.e./1 ml
English: Epoetin alfa HEXAL 1,000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2,000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 3,000 IU/0.3 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 4,000 IU/0.4 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 5,000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 6,000 IU/0.6 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 7,000 IU/0.7 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 8,000 IU/0.8 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 9,000 IU/0.9 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 10,000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 20,000 IU/0.5 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 30,000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa HEXAL 40,000 IU/1 mL solution for injection in a pre-filled syringe
Slovenian: Epoetin alfa HEXAL 1.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Epoetin alfa HEXAL 2.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Epoetin alfa HEXAL 3.000 i.e./0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Epoetin alfa HEXAL 4.000 i.e./0,4 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Epoetin alfa HEXAL 5.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Epoetin alfa HEXAL 6.000 i.e./0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Epoetin alfa HEXAL 7.000 i.e./0,7 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Epoetin alfa HEXAL 8.000 i.e./0,8 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Epoetin alfa HEXAL 9.000 i.e./0,9 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Epoetin alfa HEXAL 10.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Epoetin alfa HEXAL 20.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Epoetin alfa HEXAL 30.000 i.e./0,75 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Epoetin alfa HEXAL 40.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Further pharmacodynamic studies explored 40,000 IU once weekly versus 150 IU/kg 3 times per week.
Slovenian: V nadaljnjih farmakodinamičnih študijah so preučevali režim odmerjanja 40.000 i.e. enkrat na teden v primerjavi s 150 i.e./kg 3-krat na teden.
English: If you are given a product in this group other than Epoetin alfa HEXAL during your treatment, speak to your doctor or pharmacist before using it.
Slovenian: Če med zdravljenjem dobite drugo zdravilo iz te skupine, kot zdravilo Epoetin alfa HEXAL, se pred uporabo posvetujte s svojim zdravnikom ali farmacevtom.
English: A major cardiovascular event (death, myocardial infarction, stroke or hospitalisation 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).
Slovenian: možganska kap ali hospitalizacija zaradi kongestivne srčne odpovedi) se je pojavil pri 125 (18 %) od 715 bolnikov v skupini z večjim hemoglobinom v primerjavi s 97 (14 %) od 717 bolnikov v skupini z manjšim hemoglobinom (razmerje tveganja [RT] 1,3, 95-% IZ: 1,0; 1,7, p = 0,03).
English: Alternatively, Epoetin alfa HEXAL can be administered at an initial dose of 450 IU/kg subcutaneously once weekly.
Slovenian: Alternativno se lahko zdravilo Epoetin alfa HEXAL daje enkrat na teden, z začetnim odmerkom 450 i.e./kg, subkutano.
English: A tendency towards increased risk estimates for all-cause mortality, cardiovascular and cerebrovascular events associated with higher cumulative ESA doses independent of the diabetes or dialysis status was observed (see section 4.2 and section 4.4).
Slovenian: kardiovaskularne in cerebrovaskularne dogodke, povezane z višjimi kumulativnimi odmerki ESA, neodvisno od sladkorne boleznij ali stanja dialize (glejte poglavje 4.2 in poglavje 4.4).
English: *Pack size of 1, 4 or 6 pre-filled syringe(s) with or without a needle safety guard.
Slovenian: *Zdravilo je pakirano s po 1, 4 ali 6 napolnjenimi injekcijskimi brizgami z varnostno zaščito za iglo, ali brez te zaščite.
English: These include venous and arterial thromboses and embolism (including some with fatal outcomes), such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, and myocardial infarction.
Slovenian: Ti vključujejo venske in arterijske tromboze in embolizem (vključno z nekaj smrtnimi izidi), kot so globoka venska tromboza, pljučna embolija,
English: Caution should be exercised with escalation of Epoetin alfa HEXAL doses in patients with chronic renal failure.
Slovenian: Previdnost je potrebna pri stopnjevanju odmerkov zdravila Epoetin alfa HEXAL pri bolnikih s kronično ledvično odpovedjo.
English: In a study comparing the 150 IU/kg, 3 times per week and 40,000 IU, once-weekly dosing regimens in healthy subjects and in anaemic cancer subjects the time profiles of changes in percent reticulocytes, haemoglobin, and total red blood cells were similar between the two dosing regimens in both healthy and anaemic cancer subjects.
Slovenian: 3-krat na teden in 40.000 i.e. enkrat na teden pri zdravih osebah in pri anemičnih osebah z rakom, so bili časovni profili sprememb v odstotkih retikulocitov, hemoglobina in skupnih rdečih krvnih celic podobni med obema režimoma odmerjanja pri zdravih osebah in pri anemičnih osebah z rakom.
English: When treatment starts, Epoetin alfa HEXAL is usually injected by a medical professional or a nurse.
Slovenian: Na začetku zdravljenja vam bo zdravilo Epoetin alfa HEXAL običajno injiciral zdravnišk ali medicinsko osebje.
English: Patients should be monitored closely to ensure that the lowest approved dose of Epoetin alfa HEXAL is used to provide adequate control of anaemia and of the symptoms of anaemia.
Slovenian: Bolnike je treba skrbno spremljati, da se zagotovi uporaba najmanjšega odobrenega odmerka zdravila Epoetin alfa HEXAL za doseganje ustreznega nadzora anemije in njenih simptomov.
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.
Slovenian: Zdravilo Epoetin alfa HEXAL se uporablja pri zmerno anemičnih odraslih, naročenih na večji ortopedski kirurški poseg (na primer menjava kolka ali kolena), da se zmanjša morebitna potreba po transfuziji krvi.
English: Using the pre-filled syringe without a needle safety guard
Slovenian: Uporaba napolnjene injekcijske brizge brez varnostne zaščite za iglo
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.
Slovenian: Če se je pri vas pojavil hud izpuščaj ali kateri od teh kožnih simptomov, prenehajte z jemanjem zdravila Epoetin alfa HEXAL in se takoj posvetujte z zdravnikom ali poiščite zdravniško pomoč.
English: • Do not freeze or shake.
Slovenian: • Ne zamrzujte in ne stresajte.
English: Erythropoietin is a growth factor that primarily stimulates red cell production.
Slovenian: Eritropoetin je rastni faktor, ki primarno spodbuja nastajanje rdečih krvnih celic.
English: Once the target haematocrit was achieved, the maintenance dose was individualised for each patient.
Slovenian: so vzdrževalni odmerek prilagodili vsakemu posameznemu bolniku.
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).
Slovenian: V dvojno slepi študiji so bili bolniki zdravljeni z epoetinom alfa 600 i.e./kg ali placebom intravensko enkrat na dan vsake 3 do 4 dni v 3-tedenskem obdobju (skupaj 6 odmerkov).
English: Screening sEPO < 200 mU/mL (N) Haemoglobin (g/L) N
Slovenian: Placebo sEPO ob presejanju < 200 me./ml (N) Hemoglobin (g/l)
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.
Slovenian: Zdravilo Epoetin alfa HEXAL je eno od zdravil iz skupine, ki spodbuja nastajanje rdečih krvnih celic na enak način kot humana beljakovina eritropoetin.
English: The desired haemoglobin concentration level in two studies was > 13 g/dL (8.1 mmol/L); in the remaining three studies it was 12 to 14 g/dL (7.5 to 8.7 mmol/L).
Slovenian: V dveh študijah je bila želena raven koncentracije hemoglobina > 13 g/dl (8,1 mmol/l), v preostalih dveh pa 12 do 14 g/dl (7,5 do 8,7 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.
Slovenian: (≤ 39 % in brez osnovne anemije zaradi pomanjkanja železa), ki imajo načrtovan večji ortopedski kirurški poseg, je bila ocenjena v dvojno slepi, s placebom nadzorovani študiji, ki so jo izvedli pri 204 bolnikih, in v enojno slepi, s placebom nadzorovani študiji s 55 bolniki.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: The mean volume of distribution was 49.3 mL/kg after intravenous doses of 50 and 100 IU/kg in healthy subjects.
Slovenian: Porazdelitev Povprečni volumen porazdelitve je bil pri zdravih osebah 49,3 ml/kg po intravenskih odmerkih 50 in
English: Other medicines and Epoetin alfa HEXAL
Slovenian: Druga zdravila in zdravilo Epoetin alfa HEXAL
English: No evidence exists that indicates an interaction between epoetin alfa and granulocyte colony-stimulating factor (G-CSF) or granulocyte macrophage colony-stimulating factor (GM-CSF) with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro.
Slovenian: Ni dokazov, ki kažejo na medsebojno delovanje med epoetinom alfa in granulocitne kolonije stimulirajočim faktorjem (G-CSF) ali granulocitne/makrofagne kolonije stimulirajočim faktorjem
English: Solution for injection in a pre-filled syringe (injection) Clear, colourless solution
Slovenian: raztopina za injiciranje v napolnjeni injekcijski brizgi (injekcija) bistra, brezbarvna raztopina
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.
Slovenian: predhodno zdravljenih s hemoglobinom ≥ 10 do ≤ 13 g/dl, ki so imeli načrtovan večji ortopedski kirurški poseg na kolku ali kolenu, so primerjali epoetin alfa 300 i.e./kg, subkutano, vsak dan, 10 dni pred kirurškim posegom, na dan kirurškega posega in štiri dni po kirurškem posegu, z epoetinom alfa 600 i.e./kg, subkutano, enkrat na teden, 3 tedne pred kirurškim posegom in na dan kirurškega posega.
English: Reticulocyte count increase ≥ 40,000/µL
Slovenian: Zvečano število retikulocitov za ≥ 40.000/µl
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).
Slovenian: Zdravilo Epoetin alfa HEXAL se uporablja za zdravljenje anemije pri odraslih z boleznijo kostnega mozga, ki povzroča hude motnje pri tvorjenju krvnih celic (mielodisplastičnimi sindromi).
English: - The other ingredients are: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.
Slovenian: - Druge sestavine zdravila so: natrijev dihidrogenfosfat dihidrat, dinatrijev fosfat dihidrat, natrijev klorid, glicin, polisorbat 80, klorovodikova kislina (za uravnavanje pH), natrijev hidroksid (za uravnavanje pH) in voda za injekcije.
English: The exposure of paediatric patients with chronic renal failure on haemodialysis in clinical trials and post-marketing experience is limited.
Slovenian: Pediatrična populacija s kronično ledvično odpovedjo, ki se zdravi s hemodializo Izpostavljenost pediatričnih bolnikov s kronično ledvično odpovedjo, ki se zdravijo s hemodializo, v kliničnih preskušanjih in izkušnjah v obdobju trženja je omejena.
English: Overall survival outcome in the trials could not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group.
Slovenian: Izida za celokupno preživetje v preskušanjih se med tistimi, ki so prejemali rekombinantni humani eritropoetin, in tistimi v kontrolni skupini, ni dalo zadovoljivo razložiti s pomočjo razlik v incidenci tromboze in sorodnih zapletov.
English: • You may be given iron supplements before and during Epoetin alfa HEXAL treatment to make it more effective.
Slovenian: • Morda boste pred zdravljenjem z zdravilom Epoetin alfa HEXAL in po njem dobivali nadomestke železa, da bo zdravljenje bolj učinkovito.
English: Epoetin alfa has been studied in clinical trials in adult anaemic CRF patients, including haemodialysis and pre-dialysis patients, to treat anaemia and maintain haematocrit within a target concentration range of 30 to 36%.
Slovenian: Epoetin alfa so preučili v kliničnih preskušanjih pri odraslih anemičnih bolnikih s kronično ledvično odpovedjo, vključno z bolniki, ki se zdravijo z dializo, in z bolniki, ki se z dializo še ne zdravijo, za zdravljenje anemije in ohranjanje hematokrita v ciljnem razponu koncentracije 30 do 36 %.
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.
Slovenian: Če je ugotovljeno zvečanje ali naraščanje koncentracije kalija v serumu kljub ustreznemu zdravljenju hiperkaliemije, bo morda potrebno prekiniti zdravljenje z epoetinom alfa, dokler se raven kalija v serumu ne popravi.
English: Adults with myelodysplastic syndrome
Slovenian: Odrasli bolniki z mielodisplastičnim sindromom
English: • Before use, leave the Epoetin alfa HEXAL syringe to stand until it reaches room temperature.
Slovenian: • Pred uporabo počakajte, da zdravilo Epoetin alfa HEXAL doseže sobno temperaturo.
English: Cancer patients being treated with epoetin alfa should have haemoglobin levels measured on a regular basis until a stable level is achieved, and periodically thereafter.
Slovenian: Pri bolnikih s kroničnim ledvičnim odpovedovanjem, ki prejemajo epoetin alfa, je treba ravni hemoglobina redno meriti, dokler ni dosežena stabilna raven, potem pa v rednih časovnih intervalih.
English: You may have chest pain, breathlessness, and painful swelling and redness, usually in the leg as symptoms.
Slovenian: Morda se vam kot simptomi pojavijo bolečine v prsih, zasoplost in boleča oteklost in rdečina, običajno nog.
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).
Slovenian: Zdravilo Epoetin alfa HEXAL vsebuje zdravilno učinkovino epoetin alfa, beljakovino, ki spodbuja kostni mozeg k tvorbi rdečih krvnih celic, ki prenašajo hemoglobin (snov, ki prenaša kisik).
English: Randomised
Slovenian: Randomizirani
English: In the single-blind study, patients were treated with epoetin alfa 300 IU/kg or 600 IU/kg or placebo intravenously once daily every 3 to 4 days over 3 weeks (total 6 doses).
Slovenian: V enojno slepi študiji so bolnike zdravili z epoetinom alfa 300 i.e./kg ali 600 i.e./kg ali placebom intravensko enkrat na dan vsake 3 do 4 dni v 3-tedenskem obdobju (skupaj 6 odmerkov).
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.
Slovenian: Zdravilo Epoetin alfa HEXAL se uporablja za zdravljenje anemije pri odraslih, če prejemate kemoterapijo za solidne tumorje, maligni limfom ali multipli mielom (rak kostnega mozga), ki morda potrebujejo transfuzijo krvi.
English: Apply pressure over the injection site with a dry, sterile pad.
Slovenian: Na mesto vboda čvrsto pritisnite suho, sterilno blazinico.
English: These may affect more than 1 in 10 people.
Slovenian: Pojavijo se lahko pri največ 1 od 10 bolnikov
English: How to store Epoetin alfa HEXAL Contents of the pack and other information
Slovenian: Shranjevanje zdravila Epoetin alfa HEXAL Vsebina pakiranja in dodatne informacije
English: Your doctor will decide how Epoetin alfa HEXAL will be injected.
Slovenian: Vaš zdravnik se bo odločil, kako bo injicirano zdravilo Epoetin alfa HEXAL.
English: Therefore, epoetin alfa should not be used in patients with baseline haemoglobin > 13 g/dL (> 8.1 mmol/L).
Slovenian: Zato se epoetin alfa pri bolnikih z izhodiščno koncentracijo hemoglobina > 13 g/dl (> 8,1 mmol/l) ne sme uporabljati.
English: Name and address of the manufacturer of the biological active substance
Slovenian: SPROŠČANJE SERIJ Ime in naslov izdelovalca biološke zdravilne učinkovine
English: Epoetin alfa should be used with caution in patients with chronic liver failure.
Slovenian: Epoetin alfa je treba uporabljati previdno pri bolnikih s kronično odpovedjo jeter.
English: Epoetin alfa was evaluated in an open-label, non-randomised, open dose-range, 52-week clinical study in paediatric CRF patients undergoing haemodialysis.
Slovenian: Epoetin alfa so ocenili v odprti, nerandomizirani 52-tedenski klinični študiji z odprtim razponom odmerka pri pediatričnih bolnikih s kronično ledvično odpovedjo, zdravljenih s hemodializo.
English: The use of Epoetin alfa HEXAL in patients scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation programme is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
Slovenian: Pri bolnikih, naročenih na večji elektivni ortopedski kirurški poseg in ki niso vključeni v program avtolognega zbiranja krvi, je uporaba zdravila Epoetin alfa HEXAL kontraindicirana, če imajo hudo koronarno, periferno arterijsko, karotidno ali cerebrovaskularno bolezen ali so nedavno preboleli miokardni infarkt ali cerebrovaskularni dogodek.
English: Epoetin alfa HEXAL is prescribed to stimulate your bone marrow to produce more red blood cells.
Slovenian: Zdravilo Epoetin alfa HEXAL se predpisuje za spodbujanje kostnega mozga k tvorbi rdečih krvnih celic.
English: Subcutaneous administration
Slovenian: Subkutano dajanje
English: Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.
Slovenian: Pomožne snovi: natrijev dihidrogenfosfat dihidrat, dinatrijev fosfat dihidrat, natrijev klorid, glicin, polisorbat 80, klorovodikova kislina (za prilagajanje pH), natrijev hidroksid (za prilagajanje pH) in voda za injekcije.
English: Epoetin alfa HEXAL is presented as a clear, colourless solution for injection in a pre-filled syringe.
Slovenian: Zdravilo Epoetin alfa HEXAL je bistra, brezbarvna raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: Reticulocyte count increase ≥ 40,000/µL or Hb increase ≥ 1 g/dL
Slovenian: Zvečano število retikulocitov za ≥ 40.000/µl ali zvečanje koncentracije Hb za ≥ 1 g/dl
English: In patients scheduled for major elective orthopaedic surgery with a pretreatment haemoglobin of > 10 to ≤ 13 g/dL, epoetin alfa has been shown to decrease the risk of receiving allogeneic transfusions and hasten erythroid recovery (increased haemoglobin levels, haematocrit levels, and reticulocyte counts).
Slovenian: Zdravljenje odraslih bolnikov, naročenih na večji elektivni ortopedski kirurški poseg Pokazalo se je, da epoetin alfa pri bolnikih, naročenih na večji elektivni ortopedski kirurški poseg s hemoglobinom pred zdravljenjem > 10 do ≤ 13 g/dl, zmanjšuje tveganje za prejem alogenske transfuzije in pospeši eritroidno okrevanje (povečane ravni hemoglobina, ravni hematokrita in števila retikulocitov).
English: Included were 228 epoetin alfa-treated CRF subjects in 4 chronic renal failure studies (2 studies in pre-dialysis [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.
Slovenian: 1.404 izpostavljene osebe z rakom v 16 študijah z anemijo, ki je posledica kemoterapije; 147 izpostavljenih oseb v 2 študijah za avtolognim darovanjem krvi, 213 izpostavljenih oseb v 1 študiji v kirurškem obdobju in 102 izpostavljeni osebi v 2 študijah pri MDS.
English: Patients with CRF not on dialysis demonstrated a dose-dependent and sustained increase in haematocrit when epoetin alfa was administered by either an intravenous or subcutaneous route.
Slovenian: Pri bolnikih s kronično ledvično odpovedjo, ki se še ne zdravijo z dializo, se je pokazalo od odmerka odvisno in trajno povečanje hematokrita, ko so epoetin alfa dajali bodisi intravensko ali subkutano.