FrancophonIA/ELRC3.0 huggingface dataset:
English: Appropriate adjustment of the dose should be made in order to maintain haemoglobin levels within the desired concentration range between 9.5 g/dL to 11 g/dL (5.9 to 6.8 mmol/L).
Slovenian: Treba je ustrezno prilagoditi odmerek za vzdrževanje ravni hemoglobina v želenem razponu koncentracije med 9,5 g/dl in 11 g/dl (med 5,9 in 6,8 mmol/l).
English: Epoetin alfa should be used with caution in patients with porphyria.
Slovenian: Pri bolnikih s porfirijo je treba epoetin alfa uporabljati previdno.
English: Epoetin alfa has been shown to stimulate erythropoiesis in anaemic patients with CRF, including dialysis and pre-dialysis patients.
Slovenian: Pokazalo se je, da epoetin alfa spodbuja eritropoezo pri anemičnih bolnikih s kronično ledvično odpovedjo, vključno z bolniki, ki se zdravijo z dializo, in s tistimi, ki se z dializo še ne zdravijo.
English: Serum electrolytes should be monitored in chronic renal failure patients.
Slovenian: Pri bolnikih s kroničnim ledvičnim odpovedovanjem je treba spremljati koncentracije elektrolitov v serumu.
English: Discontinue therapy
Slovenian: Prekinitev zdravljenja
English: Only take one dose of Epoetin alfa HEXAL from each syringe discarding unwanted solution before injection.
Slovenian: Iz vsake brizge odvzemite samo en odmerek zdravila Epoetin alfa HEXAL in pred injiciranjem zavrzite preostalo raztopino.
English: The half-life of epoetin alfa following multiple dose intravenous administration is approximately 4 hours in healthy subjects.
Slovenian: Izločanje Razpolovni čas epoetina alfa po intravenskem injiciranju več odmerkov je pri zdravih osebah približno
English: From pretreatment to presurgery, the mean increase in haemoglobin in the 600 IU/kg weekly group (1.44 g/dL) was twice than that observed in the 300 IU/kg daily group (0.73 g/dL).
Slovenian: Od začetka predhodnega zdravljenja do časa pred kirurškim posegom je bilo povprečno povečanje hemoglobina v skupini s 600 i.e./kg na teden (1,44 g/dl) dvakrat večje od opaženega v skupini s
English: If the haemoglobin exceeds 13 g/dL (8.1 mmol/L), discontinue therapy until it falls below 12 g/dL (7.5 mmol/L) and then reinstitute Epoetin alfa HEXAL therapy at a dose 25% below the previous dose.
Slovenian: Če hemoglobin preseže 13 g/dl (8,1 mmol/l), je treba zdravljenje prekiniti, dokler se ne zmanjša pod 12 g/dl (7,5 mmol/l), in nato zdravljenje nadaljevati z zdravilom Epoetin alfa HEXAL z odmerkom, ki je 25 % manjši od prejšnjega odmerka.
English: Discard any unused product or waste material.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite.
English: Immune system disorders
Slovenian: Bolezni imunskega sistema preobčutljivost3
English: • feeling dizzy,
Slovenian: • bolezen jeter,
English: What Epoetin alfa HEXAL looks like and contents of the pack
Slovenian: Izgled zdravila Epoetin alfa HEXAL in vsebina pakiranja
English: More cases have been reported with subcutaneous (SC) route of administration, compared with the IV route.
Slovenian: Pri subkutani (s.c.) uporabi so poročali o več primerih kot pri intravenski (i.v.)
English: “Instructions on how to inject Epoetin alfa HEXAL yourself” can be found at the end of the package leaflet.
Slovenian: „Navodila za samoinjiciranje zdravila Epoetin alfa HEXAL“ lahko najdemo na koncu navodila za uporabo.
English: The use of epoetin alfa is not recommended in lactating surgical patients participating in an autologous blood predonation programme.
Slovenian: Uporaba epoetina alfa pri doječih ženskah, naročenih na kirurški poseg, ki sodelujejo v preddonorskem programu avtolognega zbiranja krvi, se ne priporoča.
English: If the haemoglobin concentration level exceeds 13 g/dL (8.1 mmol/L), discontinue therapy until it falls below 12 g/dL (7.5 mmol/L) and then reinitiate Epoetin alfa HEXAL therapy at a dose 25% below the previous dose.
Slovenian: Če raven koncentracije hemoglobina preseže 13 g/dl (8,1 mmol/l), je treba zdravljenje prekiniti, dokler se ne zmanjša pod 12 g/dl (7,5 mmol/l), in nato zdravljenje z zdravilom Epoetin alfa HEXAL začeti znova z odmerkom, ki je za približno 25 % manjši od predhodnega.
English: Epoetin alfa should be used with caution in the presence of untreated, inadequately treated or poorly controllable hypertension.
Slovenian: Pri bolnikih z nezdravljeno, neustrezno zdravljeno ali slabo nadzorovano arterijsko hipertenzijo je treba epoetin alfa uporabljati previdno.
English: An increase in heparin dose during haemodialysis is frequently required during the course of therapy with epoetin alfa as a result of the increased packed cell volume.
Slovenian: Med zdravljenjem z epoetinom alfa je treba zaradi zvečanega hematokrita med dializo pogosto zvečati odmerek heparina.
English: A half-life of approximately 6.2 to 8.7 hours has been reported in paediatric subjects with chronic renal failure following multiple dose intravenous administration of epoetin alfa.
Slovenian: Pri pediatričnih osebah s kronično ledvično odpovedjo so po večkratnem intravenskem odmerjanju epoetina alfa poročali o približno 6,2 do 8,7-urnem razpolovnem času.
English: The starting dose is 50 IU/kg, 3 times per week.
Slovenian: Začetni odmerek je 50 i.e./kg, 3-krat na teden.
English: Stop using Epoetin alfa HEXAL if you develop these symptoms and contact your doctor or seek medical attention immediately.
Slovenian: Če se pri vas pojavijo ti simptomi, prenehajte uporabljati zdravilo Epoetin alfa HEXAL in se takoj posvetujte z zdravnikom ali poiščite zdravniško pomoč.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL/SYRINGE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients
Slovenian: Zdravljenje simptomatske anemije pri odraslih in pediatričnih bolnikih s kroničnim ledvičnim odpovedovanjem
English: The starting dose is 50 IU/kg intravenously, 3 times per week.
Slovenian: Začetni odmerek je 50 i.e./kg intravensko, 3-krat na teden.
English: Make the next injection as soon as you remember.
Slovenian: Če ste pozabili uporabiti zdravilo Epoetin alfa HEXAL Naslednji odmerek si injicirajte takoj, ko se spomnite.
English: All other causes of anaemia (iron, folate or vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be evaluated and treated prior to initiating therapy with epoetin alfa, and when deciding to increase the dose.
Slovenian: Pred začetkom zdravljenja z epoetinom alfa in pri odločitvi za povečanje odmerka je treba oceniti in zdraviti vse druge vzroke anemije (pomanjkanje železa, folata ali vitamina B12, zastrupitev z aluminijem, okužba ali vnetje, izguba krvi, hemoliza in fibroza kostnega mozga katerega koli izvora).
English: What you need to know before you use Epoetin alfa HEXAL
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Epoetin alfa HEXAL Ne uporabljajte zdravila Epoetin alfa HEXAL:
English: • Blood clots (thrombosis) may form in your dialysis shunt.
Slovenian: • V šantu za dializo lahko nastanejo krvni strdki (tromboza).
English: - All contraindications associated with autologous blood predonation programmes should be respected in patients being supplemented with Epoetin alfa HEXAL.
Slovenian: - Pri bolnikih, ki dobivajo zdravilo Epoetin alfa HEXAL, je treba upoštevati vse kontraindikacije, povezane s preddonorskimi programi avtolognega zbiranja krvi.
English: • Diarrhoea
Slovenian: • Driska
English: Chills, Influenza like illness, Injection site reaction, Oedema peripheral
Slovenian: Splošne težave in spremembe na mestu aplikacije pireksija zelo pogosti mrzlica, gripi podobna bolezen, reakcija na mestu injiciranja, periferni edem pogosti neučinkovitost zdravila3
English: Phlebotomy may be performed if excessively high haemoglobin levels occur.
Slovenian: Pri zelo veliki koncentraciji hemoglobina lahko opravimo flebotomijo.
English: The recommended desired haemoglobin concentration range is between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L).
Slovenian: Priporočeni želeni razpon koncentracije hemoglobina je od 10 g/dl do 12 g/dl (od 6,2 do 7,5 mmol/l).
English: Chronic renal failure patients treated with epoetin alfa by the subcutaneous route should be monitored regularly for loss of efficacy, defined as absent or decreased response to epoetin alfa treatment in patients who previously responded to such therapy.
Slovenian: Pri bolnikih s slabim odzivom hemoglobina na epoetine je treba iskati druge razlage za slab odziv (glejte poglavji 4.2 in 5.1).Bolnike s kronično ledvično odpovedjo, ki se zdravijo z epoetinom alfa s subkutanim dajanjem, je treba redno spremljati zaradi morebitne izgube učinkovitosti, ki je pri bolnikih, ki so se predhodno odzivali na takšno zdravljenje, opredeljena kot odsotnost ali zmanjšan odziv na zdravljenje z epoetinom alfa.
English: Anti-erythropoietin antibody positive
Slovenian: Preiskave pozitivna preiskava za protitelesa proti eritropoietinu redki
English: • You may take Epoetin alfa HEXAL out of the refrigerator and keep it at room temperature (up to 25°C) for no longer than 3 days.
Slovenian: • Zdravilo Epoetin alfa HEXAL lahko vzamete iz hladilnika in ga hranite pri sobni temperaturi
English: Treatment of paediatric surgery patients in an autologous predonation programme
Slovenian: Zdravljenje pediatričnih bolnikov, naročenih na kirurški poseg, ki sodelujejo v avtolognem preddonorskem programu
English: This regresses during the course of continued therapy.
Slovenian: Z nadaljevanjem zdravljenja se njihovo število zmanjša.
English: Some people, depending on why they need Epoetin alfa HEXAL treatment, may later learn how to inject themselves under the skin: see
Slovenian: Nekateri posamezniki se lahko kasneje naučijo, kako si lahko zdravilo sami injicirajo pod kožo, odvisno od tega, za kaj potrebujejo zdravilo
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.
Slovenian: Epoetin alfa 600 i.e./kg (dan intravensko ali subkutano enkrat na teden) so ovrednotili v randomizirani, dvojno slepi, s placebom nadzorovani, 16-tedenski študiji in v randomizirani,
English: Breast-feeding
Slovenian: NALEPKA/BRIZGA
English: Arthralgia, Bone pain, Myalgia, Pain in extremity
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija, bolečina v kosteh, mialgija, bolečina v okončini pogosti
English: The mean CL/F for the 150 IU/kg 3 times-per-week and 40,000 IU once-weekly regimens in healthy subjects were 31.2 and 12.6 mL/h/kg, respectively.
Slovenian: enkrat na teden pri zdravih osebah je bil 31,2 oz. 12,6 ml/h/kg.
English: Pre-filled syringes*
Slovenian: Napolnjene injekcijske brizge*
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.
Slovenian: Pri anemičnih bolnikih z rakom, ki prejemajo kemoterapijo, se je pokazalo, da epoetin alfa, dan 3-krat na teden ali enkrat na teden, povečuje hemoglobin in zmanjšuje potrebo po transfuziji po prvem mesecu zdravljenja.
English: INFORMATION IN BRAILLE Epoetin alfa HEXAL 40,000 IU/1 mL
Slovenian: Epoetin alfa HEXAL 40.000 i.e./1 ml
English: If you use more Epoetin alfa HEXAL than you should Tell your doctor or nurse immediately if you think too much Epoetin alfa HEXAL has been injected.
Slovenian: Takoj obvestite svojega zdravnika ali medicinsko sestro, če mislite, da ste injicirali prevelik odmerek zdravila Epoetin alfa HEXAL.
English: A sustained haemoglobin level of greater than 12 g/dL (7.5 mmol/L) should be avoided.
Slovenian: Treba se je izogibati stalnim vrednostim hemoglobina nad 12 g/dl (7,5 mmol/l).
English: Paediatric population Treatment of symptomatic anaemia in chronic renal failure patients on haemodialysis
Slovenian: Pediatrična populacija Zdravljenje simptomatske anemije pri bolnikih s kronično ledvično odpovedjo, ki se zdravijo s hemodializo
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.
Slovenian: Na lestvici EORTC-QLQ-C30 oziroma CLAS drugi, manjši, randomizirani, s placebom nadzorovani študiji nista pokazali pomembnega izboljšanja parametrov kakovosti življenja.
English: 1 pre-filled syringe of 0.75 mL 6 pre-filled syringes of 0.75 mL 1 pre-filled syringe of 0.75 mL with a needle safety guard 4 pre-filled syringes of 0.75 mL with a needle safety guard 6 pre-filled syringes of 0.75 mL with a needle safety guard
Slovenian: 1 napolnjena injekcijska brizga z 0,75 ml 6 napolnjenih injekcijskih brizg z 0,75 ml 1 napolnjena injekcijska brizga z 0,75 ml z varnostno zaščito za iglo 4 napolnjenih injekcijskih brizg z 0,75 ml z varnostno zaščito za iglo 6 napolnjenih injekcijskih brizg z 0,75 ml z varnostno zaščito za iglo
English: INFORMATION IN BRAILLE Epoetin alfa HEXAL 20,000 IU/0.5 mL
Slovenian: Epoetin alfa HEXAL 20.000 i.e./0,5 ml
English: Epoetin alfa HEXAL contains sodium
Slovenian: Zdravilo Epoetin alfa HEXAL vsebuje natrij
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).
Slovenian: 25 i.e./kg (3-krat na teden), dokler ne dosežemo želenega cilja (to je treba narediti postopoma z vsaj štiritedenskimi časovnimi presledki).
English: In paediatric patients on haemodialysis where intravenous access is readily available, administration by the intravenous route is preferable.
Slovenian: Pri pediatričnih bolnikih na hemodializi, pri katerih je intravenski dostop takoj na razpolago, je zaželeno intravensko dajanje.
English: If you are a cancer patient be aware that products that stimulate red blood cell production (like Epoetin alfa HEXAL) may act as a growth factor and therefore in theory may affect the progression of your cancer.
Slovenian: (kot je zdravilo Epoetin alfa HEXAL), delujejo kot rastni faktor in s tem teoretično vplivajo na napredovanje raka.
English: There was no accumulation after multiple dose administration of 600 IU/kg administered subcutaneously weekly.
Slovenian: Po dajanju večkratnega odmerka 600 i.e./kg, danega subkutano enkrat tedensko, ni bilo kopičenja.
English: INFORMATION IN BRAILLE Epoetin alfa HEXAL 8,000 IU/0.8 mL 17.
Slovenian: Epoetin alfa HEXAL 8.000 i.e./0,8 ml
English: The starting dose is 50 IU/kg, 2 times per week.
Slovenian: Korekcijska faza Začetni odmerek je 50 i.e./kg, 2-krat na teden.
English: 1 pre-filled syringe of 0.9 mL contains 9,000 international units (IU) corresponding to 75.6 micrograms epoetin alfa.
Slovenian: 1 napolnjena injekcijska brizga z 0,9 ml vsebuje 9.000 mednarodnih enot (i.e.), kar ustreza 75,6 mikrogramov epoetina alfa.
English: 1 pre-filled syringe of 0.6 mL contains 6,000 international units (IU) corresponding to 50.4 micrograms epoetin alfa.
Slovenian: 1 napolnjena injekcijska brizga z 0,6 ml vsebuje 6.000 mednarodnih enot (i.e.), kar ustreza 50,4 mikrogramov epoetina alfa.
English: INFORMATION IN BRAILLE Epoetin alfa HEXAL 9,000 IU/0.9 mL 17.
Slovenian: Epoetin alfa HEXAL 9.000 i.e./0,9 ml
English: Porphyria acute3
Slovenian: Prirojene in dedne genetske okvare akutna porfirija3
English: Epoetin alfa should be used with caution in nursing women.
Slovenian: Pri doječih materah je treba epoetin alfa uporabljati previdno.
English: Epoetin alfa HEXAL 8,000 IU/0.8 mL solution for injection in a pre-filled syringe Each syringe contains 0.8 mL of solution for injection.
Slovenian: Epoetin alfa HEXAL 8.000 i.e./0,8 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 0,8 ml raztopine za injiciranje.
English: Epoetin alfa HEXAL is used to treat symptomatic anaemia caused by kidney disease: • in children on haemodialysis
Slovenian: Zdravilo Epoetin alfa HEXAL se uporablja za zdravljenje simptomatske anemije, ki jo povzroči bolezen ledvic:
English: Treatment of symptomatic anaemia in adult chronic renal failure patients
Slovenian: Zdravljenje simptomatske anemije pri odraslih bolnikih s kronično ledvično odpovedjo
English: An increased incidence of thrombotic vascular events (TVEs) has been observed in patients receiving ESAs (see section 4.8).
Slovenian: (TVE - thrombotic vascular events) (glejte poglavje 4.8).
English: INFORMATION IN BRAILLE Epoetin alfa HEXAL 30,000 IU/0.75 mL 17.
Slovenian: Epoetin alfa HEXAL 30.000 i.e./0,75 ml
English: PRCA has been very rarely reported mostly in patients with kidney disease after months to years of treatment with epoetin alfa and other products that stimulate red blood cell production.
Slovenian: Po več mesecih do letih zdravljenja z epoetinom alfa in drugimi zdravili za spodbujanje tvorbe rdečih krvnih celic so zelo redko poročali o PRCA, večinoma pri bolnikih z boleznijo ledvic.
English: 1 pre-filled syringe of 0.8 mL contains 8,000 international units (IU) corresponding to 67.2 micrograms epoetin alfa.
Slovenian: 1 napolnjena injekcijska brizga z 0,8 ml vsebuje 8.000 mednarodnih enot (i.e.), kar ustreza 67,2 mikrogramov epoetina alfa.
English: INFORMATION IN BRAILLE Epoetin alfa HEXAL 7,000 IU/0.7 mL 17.
Slovenian: Epoetin alfa HEXAL 7.000 i.e./0,7 ml
English: • Vomiting
Slovenian: • zasoplost.
English: Dose adjustment to maintain haemoglobin concentrations between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L)
Slovenian: Prilagajanje odmerka za vzdrževanje koncentracij hemoglobina med 10 g/dl in 12 g/dl (med 6,2 in 7,5 mmol/l)
English: 1 pre-filled syringe of 0.7 mL contains 7,000 international units (IU) corresponding to 58.8 micrograms epoetin alfa.
Slovenian: 1 napolnjena injekcijska brizga z 0,7 ml vsebuje 7.000 mednarodnih enot (i.e.), kar ustreza 58,8 mikrogramov epoetina alfa.
English: The median time to progression (TTP) based on investigator-determined progressive disease (PD) was 7.5 months in the epoetin alfa plus SOC group and 7.5 months in the SOC group (HR 1.099, 95% CI: 0.998, 1.210).
Slovenian: 7,5 meseca v skupini epoetin alfa in standardna nega ter 7,5 meseca v skupini samo s standardno nego (razmerje ogroženosti 1,099; 95 % IZ: 0,998; 1,210).
English: INFORMATION IN BRAILLE Epoetin alfa HEXAL 6,000 IU/0.6 mL 17.
Slovenian: Epoetin alfa HEXAL 6.000 i.e./0,6 ml
English: 1 pre-filled syringe of 1 mL contains 40,000 international units (IU) corresponding to 336.0 micrograms epoetin alfa.
Slovenian: 1 napolnjena injekcijska brizga z 1 ml vsebuje 40.000 mednarodnih enot (i.e.), kar ustreza 336,0 mikrogramov epoetina alfa.
English: per week.
Slovenian: 5 dni.
English: • the seal is broken.
Slovenian: • da je tesnilo poškodovano.
English: A haemoglobin concentration of greater than 12 g/dL (7.5 mmol/L) should be avoided.
Slovenian: Treba se je izogibati stalni koncentraciji hemoglobina nad 12 g/dl (7,5 mmol/l).
English: Adults scheduled for major orthopaedic surgery
Slovenian: Odrasli bolniki, naročeni na večji ortopedski kirurški poseg
English: 1 pre-filled syringe of 1 mL contains 2,000 international units (IU) corresponding to 16.8 micrograms epoetin alfa.
Slovenian: 1 napolnjena injekcijska brizga z 1 ml vsebuje 2.000 mednarodnih enot (i.e.), kar ustreza 16,8 mikrogramov epoetina alfa.
English: The recommended dosing regimen is described in the following diagram: 150 IU/kg 3x/week or 450 IU/kg once weekly for 4 weeks
Slovenian: 150 i.e./kg 3-krat na teden ali 450 i.e./kg 1-krat na teden
English: • Respiratory tract congestion, such as stuffy nose and sore throat, has been reported in patients with kidney disease not yet on dialysis.
Slovenian: • Pri bolnikih z boleznijo ledvic, ki se ne zdravijo z dializo, so poročali o kongestiji dihal, kot sta zamašen nos ali boleče grlo.
English: No other ESA therapy should be commenced because of the risk of cross-reaction.
Slovenian: Zaradi tveganja navzkrižne reakcije se bolniku ne sme dajati drugega eritropoetina.
English: Epoetin alfa HEXAL 8,000 IU/0.8 mL solution for injection in a pre-filled syringe EU/1/07/411/013
Slovenian: Epoetin alfa HEXAL 8.000 i.e./0,8 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/07/411/013
English: Very rarely, development of or exacerbation of porphyria has been observed in epoetin alfa-treated patients.
Slovenian: Pri bolnikih, zdravljenih z epoetinom alfa, so zelo redko opazili nastanek ali poslabšanje porfirije.
English: Patients were stratified according to their baseline haemoglobin (≤ 10 g/dL, > 10 to ≤ 13 g/dL and > 13 g/dL).
Slovenian: Bolniki so bili stratificirani glede na njihov izhodiščni hemoglobin (≤ 10 g/dl,
English: Epoetin alfa HEXAL should be administered to patients with symptomatic anaemia (e.g. haemoglobin concentration ≤ 10 g/dL (6.2 mmol/L)).
Slovenian: Zdravljenje odraslih bolnikov z MDS z nizkim ali srednjim-1 tveganjem Zdravilo Epoetin alfa HEXAL se daje bolnikom s simptomatsko anemijo (npr. koncentracijo hemoglobina ≤ 10 g/dl (6,2 mmol/l)).
English: 1 pre-filled syringe of 0.5 mL contains 20,000 international units (IU) corresponding to 168.0 micrograms epoetin alfa.
Slovenian: 1 napolnjena injekcijska igla z 0,5 ml vsebuje 20.000 mednarodnih enot (i.e.), kar ustreza 168,0 mikrogramov epoetina alfa.
English: Paediatric patients with very low initial haemoglobin (< 6.8 g/dL or < 4.25 mmol/L) may require higher maintenance doses than patients whose initial haemoglobin is higher (> 6.8 g/dL or > 4.25 mmol/L).
Slovenian: Pediatrični bolniki z zelo majhno začetno koncentracijo hemoglobina (< 6,8 g/dl ali < 4,25 mmol/l)
English: Epoetin alfa HEXAL 7,000 IU/0.7 mL solution for injection in a pre-filled syringe Each syringe contains 0.7 mL of solution for injection.
Slovenian: Epoetin alfa HEXAL 7.000 i.e./0,7 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 0,7 ml raztopine za injiciranje.
English: The median TTP based on IRC-determined PD was 8.0 months in the epoetin alfa plus SOC group and 8.3 months in the SOC group (HR 1.033, 95% CI:
Slovenian: Mediani čas do napredovanja, ki temelji na napredovali bolezni po oceni neodvisnega odbora za pregled, je bil 8,0 mesecev v skupini z epoetinom alfa in standardno nego, ter 8,3 meseca v skupini samo s standardno nego (razmerje ogroženosti 1,033; 95 % IZ: 0,924; 1,156).
English: Antibody-mediated pure red cell aplasia has been very rarely reported in < 1/10,000 cases per patient year after months to years of treatment with epoetin alfa (see section 4.4).
Slovenian: povzročene s protitelesi, po več mesecih do letih zdravljenja z epoetinom alfa (glejte poglavje 4.4).
English: Epoetin alfa HEXAL 9,000 IU/0.9 mL solution for injection in a pre-filled syringe Each syringe contains 0.9 mL of solution for injection.
Slovenian: Epoetin alfa HEXAL 9.000 i.e./0,9 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 0,9 ml raztopine za injiciranje.
English: 1 pre-filled syringe of 0.5 mL contains 5,000 international units (IU) corresponding to 42.0 micrograms epoetin alfa.
Slovenian: 1 napolnjena injekcijska brizga z 0,5 ml vsebuje 5.000 mednarodnih enot (i.e.), kar ustreza 42,0 mikrogramov epoetina alfa.
English: Healthy volunteers
Slovenian: Pomožne snovi
English: Haemoglobin variability should be addressed through dose management, with consideration for the desired haemoglobin concentration range between 10 g/dL (6.2 mmol/L) to 12 g/dL (7.5 mmol/L).
Slovenian: Nihanja hemoglobina je treba obravnavati s prilagajanjem odmerka, pri tem pa je treba upoštevati želeni razpon koncentracije hemoglobina med 10 g/dl (6,2 mmol/l) in 12 g/dl (7,5 mmol/l).
English: 1 pre-filled syringe of 0.3 mL contains 3,000 international units (IU) corresponding to 25.2 micrograms epoetin alfa.
Slovenian: 1 napolnjena injekcijska brizga z 0,3 ml vsebuje 3.000 mednarodnih enot (i.e.), kar ustreza 25,2 mikrogramov epoetina alfa.