natgillin/translations-raw huggingface dataset:
Of the patients who achieved the target, 90% did so on a 3 times-per-week dosing regimen.
90 % bolnikov, ki so cilj dosegli, je prejemalo režim 3-krat na teden.
The needle safety guard will rapidly move to cover the needle.
Varnostna zaščita igle se bo hitro premaknila in prekrila iglo.
Do not administer Epoetin alfa HEXAL by intravenous infusion or in conjunction with other medicinal product solutions (please refer to section 6.6 for further information).
Zdravila Epoetin alfa HEXAL ne dajajte v obliki intravenske infuzije ali v povezavi z drugimi raztopinami zdravil (glejte poglavje 6.6 za dodatne informacije).
• it may have been accidentally frozen, or
• da je bila raztopina pomotoma zamrznjena ali
• if there has been a refrigerator failure,
• da hladilnik ni pravilno deloval,
The decision to administer recombinant erythropoietin treatment should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context.
Odločitev o uporabi zdravljenja z rekombinantnim eritropoetinom mora temeljiti na oceni tveganja in koristi, pri kateri mora sodelovati bolnik in pri kateri je treba upoštevati tudi specifično klinično situacijo.
Pharmacotherapeutic group: other antianaemic preparations, erythropoietin, ATC code: B03XA01.
Farmakoterapevtska skupina: zdravila za zdravljenje slabokrvnosti, eritropoetin, oznaka ATC: B03XA01.
If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help.
Če ste negotovi glede dajanja injekcij ali pa imate kakršnakoli vprašanja, prosite za pomoč svojega zdravnika ali medicinsko sestro.
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.
Od skupaj 3.417 oseb v 25 randomiziranih, dvojno slepih, s placebom ali standardno nego nadzorovanih študijah, so splošni varnostni profil epoetina alfa ocenili pri 2.094 anemičnih osebah.
• An increase in levels of small blood cells (called platelets), which are normally involved in the formation of a blood clot may occur, particularly when starting treatment.
• Lahko se zvišajo ravni majhnih krvnih celic (ki se imenujejo trombociti), ki običajno sodelujejo pri nastajanju krvnih strdkov, zlasti ob začetku zdravljenja.
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the haemoglobin concentration range as recommended in section 4.2.
Pri bolnikih s kronično ledvično okvaro vzdrževalna koncentracija hemoglobina ne sme presegati zgornje meje razpona koncentracije hemoglobina, ki je priporočen v poglavju 4.2.
• Either into a vein or a tube that goes into a vein (intravenously)
• bodisi v veno ali cevko, ki gre v veno (intravensko),
In clinical trials at starting doses of 50 to 150 IU/kg, three times per week, approximately 95% of all patients responded with a clinically significant increase in haematocrit.
V kliničnih preskušanjih z začetnimi odmerki 50 do 150 i.e./kg, trikrat na teden, se je približno 95 % vseh bolnikov odzvalo s klinično pomembnim povečanjem hematokrita.
Precautions to be taken before handling or administering the medicinal product.
Pred ravnanjem z zdravilom ali dajanjem zdravila so potrebni previdnostni ukrepi.
This is characterised by a sustained decrease in haemoglobin despite an increase in epoetin alfa dosage (see section 4.8).
Zanjo je značilno trajno zmanjšanje koncentracije hemoglobina kljub povečanju odmerka epoetina alfa (glejte poglavje 4.8).
Good blood management practices should always be used in the perisurgical setting.
V perioperativnem okolju je treba vedno uporabljati dobre prakse krvne obravnave.
• For adults and children Epoetin alfa HEXAL is given as an injection either into a vein (intravenously) or a tube that goes into a vein.
• Odraslim in otrokom se daje zdravilo Epoetin alfa HEXAL v obliki injekcije bodisi v veno (intravensko) ali s cevko, ki gre v veno.
In these studies, most were predialysis patients (N = 44), 27 patients were on peritoneal dialysis and 2 were on haemodialysis with age ranging from 4 months to 17 years.
Večina bolnikov v teh študijah je bila pred dializo (n = 44), 27 bolnikov je bilo na peritonealni dializi in 2 sta bila na hemodializi; starostni razpon je bil od 4 mesece do 17 let.
If it occurs, appropriate dose adjustment should be made as provided.
Če pride do tega, je treba odmerek skladno z navodili ustrezno prilagoditi.
Conflicting reports in the literature, based on in vitro findings from human tumour samples, suggest erythropoietins may play a role as tumour proliferators.
V literaturi so nasprotujoča si poročila na podlagi izsledkov in vitro na vzorcih človeških tumorjev, ki kažejo, da eritropoetini morda igrajo vlogo pri proliferaciji tumorjev.
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Kontrolirana klinična preskušanja niso pokazala pomembnih koristi, ki bi jih pripisali dajanju epoetinov, če so koncentracije hemoglobina povečane nad koncentracijo, ki je potrebna za kontrolo simptomov anemije in izognitev transfuzijam krvi.
Since cyclosporin is bound by red blood cells (RBCs) there is potential for a medicinal product interaction.
Ker se ciklosporin veže na rdeče krvne celice (RKC), obstaja možnost medsebojnega delovanja zdravil.
A minimum of 4 weeks should elapse between dose increases.
Med povečanji odmerka morajo miniti vsaj 4 tedni.
Angioneurotic oedema3
občasni angionevrotični edem3
Headaches, particularly sudden, stabbing migraine-like headaches, feeling confused or having fits may be signs of a sudden increase in blood pressure.
Glavoboli, še zlasti nenadni, migreni podobni glavoboli z zbadanjem, stanje zmedenosti ali epileptični krči so lahko opozorilni znak nenadnega zvišanja krvnega tlaka.
The erythropoietic response observed in both treatment groups resulted in similar transfusion rates (16% in the 600 IU/kg weekly group and 20% in the 300 IU/kg daily group).
Eritropoetski odziv, ki so ga opazili v obeh skupinah zdravljenja, se je odrazil v podobnih deležih transfuzij (16 % v skupini s 600 i.e./kg na teden in 20 % v skupini s 300 i.e./kg na dan).
168.0 micrograms 252.0 micrograms 336.0 micrograms
168,0 mikrogramov 252,0 mikrogramov 336,0 mikrogramov
For patients on peritoneal dialysis Epoetin alfa HEXAL may be given twice a week.
Bolniki na peritonealni dializi lahko dobivajo zdravilo Epoetin alfa HEXAL dvakrat na teden.
• The usual starting dose of Epoetin alfa HEXAL for adults and children is 50 International Units (IU) per kilogram (/kg) of body weight given three times a week.
• Običajni začetni odmerek zdravila Epoetin alfa HEXAL za odrasle in otroke je 50 mednarodnih enot (i.e.) na kilogram (/kg) telesne mase, trikrat na teden.
• Symptoms of pure red cell aplasia (PRCA)
• Simptomi čiste aplazije rdečih krvnih celic (PRCA)
Erythropoietin (EPO) is a glycoprotein hormone produced primarily by the kidney in response to hypoxia and is the key regulator of red blood cell (RBC) production.
Eritropoetin (EPO) je glikoproteinski hormon, ki nastaja pretežno v ledvicah kot odziv na hipoksijo in je ključni regulator nastajanja rdečih krvnih celic (RKC).
Your doctor will monitor your blood pressure regularly while you are using Epoetin alfa HEXAL.
Zdravnik bo redno nadziral vaš krvni tlak, medtem ko uporabljate zdravilo Epoetin alfa HEXAL.
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.
Kljub razlikam v profilih koncentracije v odvisnosti od časa je bil farmakodinamični odziv (merjen glede na odstotne spremembe retikulocitov, hemoglobina in skupnih RKC) med tema režimoma podoben.
• Your doctor may initiate treatment with Epoetin alfa HEXAL if your haemoglobin is 10 g/dL or less.
• Vaš zdravnik lahko uvede zdravljenje z zdravilom Epoetin alfa HEXAL, ko je vaš hemoglobin 10 g/dl ali manj.
Clean the skin at the injection site using an alcohol wipe.
Kožo na mestu injiciranja očistite z alkoholnim robčkom.
Overdosage of epoetin alfa may produce effects that are extensions of the pharmacological effects of the hormone.
Preveliko odmerjanje epoetina alfa lahko povzroči stopnjevanje farmakoloških učinkov hormona.
If possible, iron supplementation should be initiated prior to starting epoetin alfa therapy to achieve adequate iron stores.
Če je mogoče, je treba z nadomeščanjem železa začeti pred zdravljenjem z epoetinom alfa, da se dosežejo ustrezne zaloge železa.
The greatest effects are observed in patients with low haemoglobin (≤ 13 g/dL).
Največje učinke so opazili pri bolnikih z nizkim hemoglobinom (≤ 13 g/dl).
Following subcutaneous injection, serum levels of epoetin alfa reach a peak between 12 and 18 hours post-dose.
Absorpcija Po subkutanem injiciranju dosežejo ravni epoetina alfa v serumu vrhunec med 12 in 18 urami po odmerku.
The therapeutic margin of epoetin alfa is very wide.
Terapevtski razpon epoetina alfa je zelo širok.
Do not release the pressure on the plunger!
Pritiska na bat ne sprostite!
• Swelling of the ankles, feet or fingers.
• Oteklina gležnjev, stopal ali prstov.
Bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
Fibroza kostnega mozga je znan zaplet pri ljudeh s kroničnim ledvičnim odpovedovanjem in je lahko povezana s sekundarnim hiperparatiroidizmom ali neznanimi dejavniki.
Usually the injections will be given to you by a doctor, nurse or other health care professional.
Injekcijo običajno da vaš zdravnik, medicinska sestra ali drugo zdravniško osebje.
• Redness, burning and pain at the site of injection.
• Rdečina, skelenje in bolečina na mestu injiciranja.
• a swollen face, lips, mouth, tongue or throat,
• otekanje obraza, ustnic, ust, jezika ali grla, • težave s požiranjem ali dihanjem,
Do not double up the injections to make up for a forgotten dose.
Ne injicirajte si dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
These changes are interpreted as being secondary to decreased maternal body weight gain, and the significance to humans is unknown given therapeutic dose levels.
Spremembe si lahko razložimo kot posledico materinega počasnega pridobivanja telesne mase in njihov pomen za ljudi, ki prejemajo terapevtske odmerke, ni znan.
No a one subject did not have sEPO data b in the ≥ 200 mU/mL stratum there were 13 subjects in the epoetin alfa group and 6 subjects in the placebo group
Ne a za eno osebo ni bilo na voljo podatkov o sEPO b v skupini ≥ 200 me./ml je bilo 13 oseb iz skupine, ki je prejemala epoetin alfa, in 6 oseb iz skupine, ki je prejemala placebo
• Always use Epoetin alfa HEXAL exactly as instructed by your doctor or nurse.
• Zdravilo Epoetin alfa HEXAL vedno uporabljajte natančno po navodilih svojega zdravnika ali medicinske sestre.
- in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients (see section 4.4).
- pri odraslih z ledvično insuficienco, ki še niso vključeni v dializno zdravljenje, za zdravljenje hude anemije zaradi bolezni ledvic s spremljajočimi kliničnimi simptomi pri bolnikih (glejte poglavje 4.4).
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Te študije so pokazale skladno, nerazložljivo, statistično značilno povečano umrljivost bolnikov, pri katerih je bila anemija povezana z različnimi, pogostimi vrstami raka in ki so prejemali rekombinantni humani eritropoetin, v primerjavi s kontrolno skupino.
If you are a cancer patient, be aware that use of Epoetin alfa HEXAL may be associated with shorter survival and a higher death rate in head and neck, and metastatic breast cancer patients who are receiving chemotherapy.
Če ste bolnik z rakom, morate vedeti, da je uporaba zdravila Epoetin alfa HEXAL lahko povezana s krajšim preživetjem in večjimi stopnjami smrtnosti pri bolnikih z rakom v glavi in vratu ter metastatskim rakom dojke, ki prejemajo zdravljenje s kemoterapijo.
Please discuss with your doctor.
Posvetujte se s svojim zdravnikom.
Once a syringe has been removed from the refrigerator and has reached room temperature (up to 25°C) it must either be used within 3 days or disposed of.
Ko ste injekcijsko brizgo vzeli iz hladilnika in je bila segreta na sobno temperaturo (ne višjo kot 25 °C), jo je treba uporabiti v 3 dneh ali zavreči.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy with epoetin alfa taking into account the benefit of breast-feeding for the child and the benefit of epoetin alfa therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prekinitvijo/prenehanjem zdravljenja z epoetinom alfa, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja z epoetinom alfa za mater.
These patients responded to epoetin alfa therapy in a manner similar to that observed in patients on dialysis.
Ti bolniki so se na zdravljenje z epoetinom alfa odzvali na podoben način, kot je bilo opaženo pri bolnikih na dializi.
Epoetin alfa therapy should continue until one month after the end of chemotherapy.
Zdravljenje z epoetinom alfa je treba nadaljevati do enega meseca po koncu kemoterapije.
Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section 4.4).
Metaanalize so dosledno pokazale tudi višje zvišanje relativnega tveganja trombemboličnih dogodkov pri bolnikih z rakom, ki so prejemali rekombinantni humani eritropoietin (glejte poglavje 4.4).
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).
Povprečno so lahko bolniki, zdravljeni z epoetinom alfa, deponirali znatno več enot krvi (4,5 enot) kot bolniki, ki so prejemali placebo (3,0 enote).
• if you have been diagnosed with Pure Red Cell Aplasia (the bone marrow cannot produce enough red blood cells) after previous treatment with any product that stimulates red blood cell production (including Epoetin alfa HEXAL).
• če so vam postavili diagnozo aplazija rdečih krvnih celic (kostni mozeg ne more tvoriti dovolj rdečih krvnih celic) po predhodnem zdravljenju s katerim koli zdravilom, ki spodbuja nastajanje rdečih krvnih celic (vključno z zdravilom Epoetin alfa HEXAL).
Erythroid response was defined according to International Working Group (IWG) 2006 criteria as a haemoglobin increase ≥ 1.5 g/dL from baseline or a reduction of RBC units transfused by an absolute number of at least 4 units every 8 weeks compared to the 8 weeks prior to baseline, and a response duration of at least 8 weeks.
Eritroidni odziv je bil opredeljen po merilih Mednarodne delovne skupine iz leta 2006 kot zvišanje ravni hemoglobina za ≥ 1,5 g/dl od izhodišča ali zmanjšanje absolutnega števila RKC, prejetih s transfuzijo, za vsaj 4 enote vsakih 8 tednov v primerjavi z 8 tedni pred izhodiščem in trajanje odziva vsaj 8 tednov.
Subjects were stratified by serum erythropoetin (sEPO) level and prior transfusion status at screening.
Osebe so bile stratificirane glede na raven eritropoetina v serumu (sEPO) in podatke o predhodnih transfuzijah ob presejanju.
The most frequent adverse drug reaction during treatment with epoetin alfa is a dose-dependent increase in blood pressure or aggravation of existing hypertension.
Najpogostejši neželeni učinek zdravila med zdravljenjem z epoetinom alfa je od odmerka odvisno zvišanje krvnega tlaka ali poslabšanje obstoječe hipertenzije.
While maintaining pressure on the plunger, remove the syringe from the patient.
Medtem, ko še vedno vzdržujete pritisk na bat, odstranite iglo iz bolnika.
If you are a patient with hepatitis C and you receive interferon and ribavirin, you should discuss this with your doctor because a combination of epoetin alfa with interferon and ribavirin has led to a loss of effect and development of a condition called pure red cell aplasia (PRCA), a severe form of anaemia, in rare cases.
Če ste bolnik s hepatitisom C in prejemate interferon in ribavirin, se morate o tem pogovoriti s svojim zdravnikom, saj je kombinacija epoetina alfa z interferonom in ribavirinom v redkih primerih povzročila izgubo učinka in razvoj stanja, imenovanega čista aplazija rdečih krvnih celic (PRCA
Recombinant human EPO (epoetin alfa), expressed in Chinese hamster ovary cells, has a 165 amino acid sequence identical to that of human urinary EPO; the 2 are indistinguishable on the basis of functional assays.
Rekombinantni humani EPO (epoetin alfa), izražen v ovarijskih celicah kitajskega hrčka, ima 165 aminokislin dolgo zaporedje, identično tistemu, ki ga ima EPO v človekovem urinu; med tema dvema ni razlike na podlagi funkcionalnih testov.
A maximum volume of 1 mL at one injection site should generally not be exceeded.
Največji volumen na enem mestu injiciranja naj ne preseže 1 ml.
Pack of 1, 4 or 6 syringes.
Pakiranja po 1, 4 ali 6 brizg.
Epoetin alfa HEXAL is provided with or without a needle safety guard and you will be shown how to use this by your doctor or nurse.
Zdravilo Epoetin alfa HEXAL je opremljeno z zaščito za iglo ali pa je brez nje, vaš zdravnik ali medicinska sestra pa vam bosta pokazala, kako to uporabljati.
Hypertension, Venous and arterial thromboses2
Žilne bolezni hipertenzija, venska in arterijska tromboza2
Epoetin alfa therapy reduced the risk of exposure to allogeneic blood by 50% compared to patients not receiving epoetin alfa.
Zdravljenje z epoetinom alfa je zmanjšalo tveganje izpostavljenosti alogenski krvi za 50 % v primerjavi z bolniki, ki niso dobivali epoetina alfa.
Pack of 1 or 6 syringes.
Pakiranja po 1 ali 6 brizg.
However the product is for single use only.
Vendar je zdravilo samo za enkratno uporabo.
The dose of Epoetin alfa HEXAL you receive is based on your body weight in kilograms.
Odmerek zdravila Epoetin alfa HEXAL, ki ga boste prejeli, je odvisen od vaše telesne mase v kilogramih.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika, medicinsko sestro ali farmacevta.
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.
To je bila študija neinferiornosti, zasnovana za izključitev 15-odstotnega povečanja tveganja napredovanja tumorja ali smrti pri epoetinu alfa in standardni negi v primerjavi samo s standardno nego.
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).
Mediani čas od izhodišča do prve transfuzije je bil statistično značilno daljši v skupini, ki je prejemala epoetin alfa, v primerjavi s skupino, ki je prejemala placebo (49 v primerjavi s 37 dnevi; p = 0,046).
- For cancer patients, iron supplementation (elemental iron 200 to 300 mg/day orally) is recommended if transferrin saturation is below 20%.
- Pri bolnikih z rakom priporočamo dajanje nadomestkov železa (elementarno železo 200 do 300 mg/dan peroralno), če je saturacija transferina manjša od 20 %.
• If you do not respond adequately to Epoetin alfa HEXAL, your doctor will check your dose and will inform you if you need to change doses of Epoetin alfa HEXAL.
• Če se na zdravljenje z zdravilom Epoetin alfa HEXAL ne odzivate ustrezno, bo zdravnik preveril vaš odmerek in vas obvestil, če morate spremeniti odmerke zdravila Epoetin alfa HEXAL.
The injections should be given in the limbs or the anterior abdominal wall.
Zdravilo je treba injicirati na okončinah ali na sprednji steni trebuha.
Pre-filled syringes (glass type I), with or without a needle safety guard, with plunger stopper (Teflon-faced rubber) sealed in a blister.
Napolnjene injekcijske brizge (steklo tipa I), z varnostno zaščito za iglo ali brez nje, z zamaškom z batom (s teflonom prevlečena guma) v pretisnem omotu.
Each graduation ring corresponds to a volume of 0.1 mL.
Ena oznaka ustreza volumnu 0,1 ml.
Later, your doctor may suggest that you or your caregiver learn how to inject Epoetin alfa HEXAL under the skin (subcutaneously) yourself.
Kasneje lahko zdravnik predlaga, da se vi ali vaš skrbnik naučite, kako si injicirati zdravilo Epoetin alfa HEXAL pod kožo (subkutano).
A randomised prospective trial evaluated 1,432 anaemic chronic renal failure patients who were not undergoing dialysis.
V randomiziranem prospektivnem preskušanju so ocenili 1.432 anemičnih bolnikov s kronično ledvično odpovedjo, ki se še niso zdravili z dializo.
In those situations in which the physician determines that a patient or caregiver can safely and effectively administer Epoetin alfa HEXAL subcutaneously themselves, instruction as to the proper dosage and administration should be provided.
Če zdravnik oceni, da lahko bolnik ali negovalec zdravilo Epoetin alfa HEXAL varno in učinkovito subkutano injicira sam, mu je treba dati navodila za pravilno odmerjanje in dajanje.
If partial use of a syringe is required, remove unwanted solution before injection.
Če je potrebna delna uporaba brizge, pred injiciranjem odstranite odvečno raztopino.
- in adults and children aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis (see section 4.4).
- pri odraslih in otrocih, starih 1 do 18 let, ki se zdravijo s hemodializo, in odraslih bolnikih, ki se zdravijo s peritonealno dializo (glejte poglavje 4.4).
Pure Red Cell Aplasia (PRCA)
Aplazija rdečih krvnih celic (PRCA - pure red cell aplasia)
Instructions on how to inject yourself (for patients with symptomatic anaemia caused by kidney disease, for adult patients receiving chemotherapy, adult patients scheduled for orthopaedic surgery, or adult patients with myelodysplastic syndromes only)
Navodila za samoinjiciranje (samo za bolnike s simptomatsko anemijo, ki jo povzroči bolezen ledvic, za odrasle bolnike, ki prejemajo kemoterapijo, ali odrasle bolnike, naročene na ortopedski kirurški poseg, ali odrasle bolnike s samo mielodisplastičnimi sindromi)
In the 16-week study (n = 222), in the epoetin alfa-treated patients there was no statistically significant effect on patient-reported or parent-reported Paediatric Quality of Life Inventory or Cancer Module scores compared with placebo (primary efficacy endpoint).
V 16-tedenski študiji (n = 222) ni bilo pri bolnikih, zdravljenih z epoetinom alfa, nobenega statistično značilnega učinka na kakovost življenja, kot so poročali bolniki ali starši, glede na seštevke pediatričnega vprašalnika o kakovosti življenja (Paediatric Quality of Life Inventory) ali modul za raka (Cancer Module) v primerjavi s placebom (primarni opazovani dogodek učinkovitosti).
Syringes are embossed with graduation rings in order to enable partial use if required.
Brizge imajo oznako v obliki obroča, ki omogoča delno uporabo, če je to potrebno.
It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Pomembno je, da injekcije sami sebi ne poskušate dati, če vas za to nista posebej usposobila vaš zdravnik ali medicinska sestra.
Epoetin alfa HEXAL should be administered after the completion of the blood donation procedure.
Zdravilo Epoetin alfa HEXAL je treba uporabiti po tem, ko je postopek darovanja krvi končan.
In repeated dose toxicological studies in dogs and rats, but not in monkeys, epoetin alfa therapy was associated with subclinical bone marrow fibrosis.
Nekatere toksikološke študije pri ponavljajočih odmerkih na psih in podganah, toda ne na opicah, so pokazale, da je zdravljenje z epoetinom alfa povezano s subklinično fibrozo kostnega mozga.