natgillin/translations-raw huggingface dataset:
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.
Blago anemične bolnike (hematokrit 33 do 39 %), ki potrebujejo ≥ 4 enote deponirane krvi, je treba zdraviti z zdravilom Epoetin alfa HEXAL 600 i.e./kg, intravensko, 2-krat na teden, 3 tedne pred kirurškim posegom.
Depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further.
Bat počasi in enakomerno pritisnite navzdol, dokler se ne vbrizga celotnega odmerka in bata ni mogoče potisniti še naprej.
• Epoetin alfa HEXAL is given by injection under the skin each week for three weeks before surgery and on the day of surgery.
• Zdravilo Epoetin alfa HEXAL se injicira pod kožo vsak teden tri tedne pred kirurškim posegom in na dan kirurškega posega.
• Nose or airway congestion.
• Kongestija nosu ali dihal.
Hypersensitivity reactions, including cases of rash (including urticaria), anaphylactic reactions, and angioneurotic oedema have been reported (see section 4.4).
Poročali so o preobčutljivostnih reakcijah, vključno s primeri izpuščaja (vključno z urtikarijo), anafilaktičnih reakcijah in angionevrotičnem edemu (glejte poglavje 4.4).
Particular attention should be paid to sudden stabbing migraine-like headaches as a possible warning signal (see section 4.8).
Posebno pozornost je treba nameniti nenadnemu pojavu migreni podobnih glavobolov z zbadanjem, ki so lahko možen opozorilni znak (glejte poglavje 4.8).
Patients should be monitored closely to ensure that the lowest approved effective dose of Epoetin alfa HEXAL is used to provide adequate control of anaemia and of the symptoms of anaemia whilst maintaining a haemoglobin concentration below or at 12 g/dL (7.5 mmol/L).
Bolnike je treba skrbno spremljati, da se zagotovi uporaba najmanjšega odobrenega učinkovitega odmerka zdravila Epoetin alfa HEXAL za doseganje ustreznega nadzora anemije in simptomov anemije ob hkratnem ohranjanju koncentracije hemoglobina pod ali pri 12 g/dl (7,5 mmol/l).
Where intravenous access is not readily available (patients not yet undergoing dialysis and peritoneal dialysis patients) Epoetin alfa HEXAL may be administered as a subcutaneous injection.
Kjer intravenski dostop ni takoj na razpolago (bolniki, ki se še ne zdravijo z dializo, in bolniki na peritonealni dializi), se zdravilo Epoetin alfa HEXAL lahko daje v obliki subkutane injekcije.
People with kidney disease
Osebe z boleznijo ledvic
• Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Epoetin alfa HEXAL treatment.
• Vaš zdravnik bo naročil krvne preiskave in po potrebi prilagodil odmerek, odvisno od odziva vaše anemije na zdravljenje z zdravilom Epoetin alfa HEXAL.
In a double-blind, placebo-controlled, multicentre, quality of life study in CRF patients on haemodialysis, clinically and statistically significant improvement was shown in the patients treated with epoetin alfa compared to the placebo group when measuring fatigue, physical symptoms, relationships and depression (Kidney Disease Questionnaire) after six months of therapy.
V dvojno slepi, s placebom nadzorovani, multicentrični študiji kakovosti življenja bolnikov s kronično ledvično odpovedjo na hemodializi se je po šestih mesecih zdravljenja pokazalo klinično in statistično značilno izboljšanje pri bolnikih, zdravljenih z epoetinom alfa, v primerjavi s skupino s placebom, za izmerjeno utrujenost, telesne simptome, razmerja in depresijo (Vprašalnik za bolezen ledvic).
10,000 IU/mL: 3,000 IU/0.3 mL 4,000 IU/0.4 mL 5,000 IU/0.5 mL 6,000 IU/0.6 mL 7,000 IU/0.7 mL 8,000 IU/0.8 mL 9,000 IU/0.9 mL 10,000 IU/1 mL
10.000 i.e./ml: 3.000 i.e./0,3 ml 4.000 i.e./0,4 ml 5.000 i.e./0,5 ml 6.000 i.e./0,6 ml 7.000 i.e./0,7 ml 8.000 i.e./0,8 ml 9.000 i.e./0,9 ml 10.000 i.e./1 ml
No paediatric-specific adverse reactions not mentioned previously in the table above, or any that were not consistent with the underlying disease were reported in this population.
Pri tej populaciji niso poročali o neželenih učinkih, specifičnih za pediatrično populacijo, ki ne bi že bili prej omenjeni v zgornji preglednici, ali ki ne bili bili skladni z osnovno boleznijo.
Similar rates of rise of haematocrit were noted when epoetin alfa was administered by either route.
Podobne stopnje porasta hematokrita so opazili, ko so epoetin alfa dajali po kateri koli poti.
What Epoetin alfa HEXAL is and what it is used for
Kaj je zdravilo Epoetin alfa HEXAL in za kaj ga uporabljamo
Epoetin alfa 300 IU/kg significantly reduced the risk of allogeneic transfusion in patients with a pretreatment haemoglobin of > 10 to ≤ 13 g/dL.
Epoetin alfa 300 i.e./kg je pomembno zmanjšal tveganje za alogensko transfuzijo krvi pri bolnikih, predhodno zdravljenih s hemoglobinom > 10 do ≤ 13 g/dl.
Solution for injection in a pre-filled syringe.
Raztopina za injiciranje v napolnjeni injekcijski brizgi.
• epileptic seizures or fits;
• epileptične napade ali krče,
Epoetin alfa HEXAL is indicated in adults in a predonation programme to increase the yield of autologous blood.
Zdravilo Epoetin alfa HEXAL je indicirano pri odraslih v preddonorskem programu za povečanje količine pridobljene avtologne krvi.
Shunt thromboses have occurred in haemodialysis patients, especially in those who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e.g. stenoses, aneurysms, etc.).
Pri bolnikih na hemodializi so se pojavile tromboze šanta, še zlasti pri tistih, ki so nagnjeni k hipotenziji ali z zapleti arteriovenske fistule (npr. stenoze, anevrizme itd.).
In studies to explore extending the dosing interval (40,000 IU once weekly and 80,000, 100,000, and 120,000 IU biweekly), a linear but non-dose-proportional relationship was observed between mean Cmax and dose, and between mean AUC and dose at steady state.
V študijah, v katerih so raziskali podaljšan interval odmerjanja (40.000 i.e. enkrat na teden ter 80.000, 100.000 in 120.000 i.e. na vsaka dva tedna), so opazili linearno razmerje, ki ni bilo sorazmerno z odmerkom, med povprečnim Cmax in odmerkom ter med povprečnim AUC in odmerkom v stanju dinamičnega ravnovesja.
Significantly fewer patients received RBC transfusions in the epoetin alfa plus SOC arm (5.8% versus 11.4%); however, significantly more patients had thrombotic vascular events in the epoetin alfa plus SOC arm (2.8% versus 1.4%).
Značilno manj bolnikov je prejelo transfuzije RKC v kraku z epoetinom alfa in standardno nego (5,8 % v primerjavi z 11,4 %); vendar pa je imelo značilno več bolnikov trombotične žilne dogodke v kraku z epoetinom alfa in standardno nego (2,8 % v primerjavi z 1,4 %).
The effect of epoetin alfa (300 IU/kg or 100 IU/kg) on the exposure to allogeneic blood transfusion has been evaluated in a placebo-controlled, double-blind clinical trial in non-iron deficient adult patients scheduled for major elective orthopaedic hip or knee surgery.
Učinek epoetina alfa (300 i.e./kg ali 100 i.e./kg) na izpostavljenost alogenski transfuziji krvi so ocenili v s placebom nadzorovanem, dvojno slepem kliničnem preskušanju pri odraslih bolnikih brez pomanjkanja železa, ki imajo načrtovan večji elektivni ortopedski kirurški poseg na kolku ali kolenu.
Additional studies compared the 40,000 IU once-weekly regimen of epoetin alfa with biweekly doses ranging from 80,000 to 120,000 IU subcutaneously.
V dodatnih študijah so primerjali režim epoetina alfa 40.000 i.e. enkrat na teden z odmerki enkrat na dva tedna od 80.000 do 120.000 i.e., subkutano.
Use the syringe within 3 days of taking it out of the refrigerator.
Ko injekcijsko brizgo vzamete iz hladilnika, jo porabite v roku 3 dni.
While on Epoetin alfa HEXAL, some people need medicines to reduce the risk of blood clots.
Med uporabo zdravila Epoetin alfa HEXAL morajo nekatere osebe jemati zdravila za zmanjšanje tveganja za nastanek krvnih strdkov.
Treatment should only be given to patients with moderate anaemia (haemoglobin [Hb] concentration range between 10 to 13 g/dL [6.2 to 8.1 mmol/L], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Zdravilo Epoetin alfa HEXAL smemo uporabiti samo pri bolnikih z zmerno anemijo (razpon koncentracije hemoglobina [Hb] od 10 do 13 g/dl [6,2 do 8,1 mmol/l] brez pomanjkanja železa), če postopki za ohranjanje krvi niso na voljo ali ne zadostujejo, kadar je za večji elektivni kirurški poseg potrebna velika količina krvi (4 ali več enot krvi za ženske ali 5 ali več enot za moške).
• If there is a medical need to reduce the time before your operation, you will be given a daily dose of 300 IU/kg for up to ten days before surgery, on the day of surgery and for four days immediately afterwards.
• Če obstaja medicinska potreba za zmanjšanje časa pred kirurškim posegom, boste prejemali dnevni odmerek 300 i.e./kg do deset dni pred kirurškim posegom, na dan posega in še štiri dni po posegu.
Epoetin alfa has been shown to stimulate red blood cell production in order to augment autologous blood collection, and to limit the decline in haemoglobin in adult patients scheduled for major elective surgery who are not expected to predeposit their complete perioperative blood needs.
Pokazalo se je, da epoetin alfa spodbuja nastajanje rdečih krvnih celic z namenom povečanja odvzema avtologne krvi in zmanjšanja upada hemoglobina pri odraslih bolnikih, naročenih na večji elektivni kirurški poseg, pri katerih se ne pričakuje, da bodo zbrali kri za vse njihove potrebe pri operaciji.
There are no or limited amount of data from the use of epoetin alfa in pregnant women.
Podatkov o uporabi epoetina alfa pri nosečnicah ni oziroma so omejeni.
At the time of clinical data cutoff, the median progression free survival (PFS) per investigator assessment of disease progression was 7.4 months in each arm (HR 1.09, 95% CI: 0.99, 1.20), indicating the study objective was not met.
V času kliničnega preseka je bilo mediano preživetje brez napredovanja (PFS - progression free survival) po raziskovalčevi oceni napredovanja bolezni 7,4 mesece v vsakem kraku (razmerje ogroženosti 1,09; 95 % IZ: 0,99; 1,20), kar kaže, da cilj študije ni bil dosežen.
In most anaemic subjects with cancer receiving cyclic chemotherapy, CL/F was lower after subcutaneous doses of 40,000 IU once weekly and 150 IU/kg, 3 times-per-week compared with the values for healthy subjects.
Pri večini anemičnih oseb z rakom, ki so prejemale ciklično kemoterapijo, je bil CL/F po subkutanih odmerkih 40.000 i.e enkrat na teden in 150 i.e./kg 3-krat na teden nižji v primerjavi z vrednostmi za zdrave osebe.
You may still be able to use Epoetin alfa HEXAL, but discuss it with your doctor first:
Morda boste lahko še vedno uporabljali zdravilo Epoetin alfa HEXAL, vendar se najprej posvetujte s svojim zdravnikom:
The safety and efficacy of epoetin alfa in paediatrics have not been established.
Varnost in učinkovitost epoetina alfa pri pediatričnih bolnikih nista bili dokazani.
Available evidence suggests patients with haematological malignancies and solid tumours respond equivalently to epoetin alfa therapy, and that patients with or without tumour infiltration of the bone marrow respond equivalently to epoetin alfa therapy.
Razpoložljivi dokazi kažejo, da se bolniki s hematološkimi malignostmi in solidnimi tumorji na zdravljenje z epoetinom alfa odzivajo ekvivalentno in da se bolniki z infiltracijo tumorja v kostni mozeg in brez nje na zdravljenje z epoetinom alfa odzivajo ekvivalentno.
The needle safety guard covers the needle after injection to prevent needle stick injury.
Uporaba napolnjene injekcijske brizge z varnostno zaščito za iglo Varnostna zaščita za iglo po injiciranju iglo prekrije, da bi tako preprečila poškodbe zaradi vboda z iglo.
Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dL or 6.2 to 8.1 mmol/L) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1,800 mL).
Uporabo je treba omejiti na bolnike z zmerno anemijo (npr. razpon koncentracije hemoglobina od 10 do 13 g/dl ali od 6,2 do 8,1 mmol/l), ki jim program avtolognega darovanja krvi ni na voljo in pri katerih se pričakuje zmerna izguba krvi (od
After injecting the liquid, remove the needle and let go of your skin.
Ko ste raztopino vbrizgali, iglo izvlecite in kožo izpustite.
The most frequently occurring adverse drug reactions observed in clinical trials of epoetin alfa are diarrhoea, nausea, vomiting, pyrexia and headache.
Najpogostejši neželeni učinki zdravila, ki so se pojavili v kliničnih preskušanjih z epoetinom alfa, so driska, navzea, bruhanje, pireksija in glavobol.
A rise in haemoglobin of greater than 2 g/dL over a four week period should be avoided.
Izogibati se je treba zviševanju hemoglobina za več kot 2 g/dl v obdobju štirih tednov.
• Arm or leg pain.
• Bolečina v roki ali nogi.
• Do not attempt to inject yourself unless you have been trained to do so by your doctor or nurse.
• Zdravila si ne poskušajte injicirati sami, če vas tega ni naučil zdravnik ali medicinska sestra.
The safety of epoetin alfa has not been established in patients with hepatic dysfunction.
Varnost epoetina alfa ni bila dokazana pri bolnikih z jetrno disfunkcijo.
In the 20-week study (n = 225), no significant difference was observed in the primary efficacy endpoint, i.e. the proportion of patients who required a RBC transfusion after Day 28 (62% of epoetin alfa patients versus 69% of standard therapy patients).
V 20-tedenski študiji (n = 225) niso opazili značilnih razlik v primarnem opazovanem dogodku učinkovitosti, tj. v deležu bolnikov, pri katerih je bila potrebna transfuzija RKC po 28. dnevu (62 %
It is recommended that the platelet count is regularly monitored during the first 8 weeks of therapy.
V prvih osmih tednih zdravljenja se priporoča redno spremljanje števila trombocitov.
A randomised, double-blind, placebo-controlled, multicentre study evaluated the efficacy and safety of epoetin alfa in adult anaemic subjects with low- or intermediate-1-risk MDS.
V randomizirani, dvojno slepi, s placebom nadzorovani multicentrični študiji so ocenjevali učinkovitost in varnost epoetina alfa pri odraslih osebah z anemijo in MDS z nizkim ali srednjim-1
Epoetin alfa HEXAL is indicated for the treatment of symptomatic anaemia (haemoglobin concentration of ≤ 10 g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (< 200 mU/mL).
Zdravilo Epoetin alfa HEXAL je indicirano za zdravljenje simptomatske anemije (koncentracija hemoglobina ≤ 10 g/dl) pri odraslih s primarnimi mielodisplastičnimi sindromi (MDS) z nizkim ali srednjim-1 tveganjem, ki imajo nizke vrednosti eritropoetina v serumu (< 200 me./ml).
300 IU/kg
300 i.e./kg
Epoetin alfa HEXAL is indicated in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy) for the treatment of anaemia and reduction of transfusion requirements.
Zdravilo Epoetin alfa HEXAL je indicirano za zdravljenje odraslih, pri katerih s kemoterapijo zdravimo solidne tumorje, maligni limfom ali multipli mielom, in pri tveganju za transfuzijo, ki ga ocenimo glede na bolnikovo splošno zdravstveno stanje (npr. kardiovaskularni status, prisotnost anemije že na začetku zdravljenja s kemoterapijo) za zdravljenje anemije in zmanjšanje potrebe po transfuziji.
Epoetin alfa HEXAL can reduce the need for a blood transfusion.
Zdravilo Epoetin alfa HEXAL lahko zmanjša potrebo po transfuziji krvi.
Patients scheduled for major elective orthopaedic surgery should receive adequate antithrombotic prophylaxis, as thrombotic and vascular events may occur in surgical patients, especially in those with underlying cardiovascular disease.
Bolniki, naročeni na večji elektivni ortopedski poseg, morajo prejeti ustrezno antiagregacijsko profilakso zaradi tveganja za trombotične in žilne dogodke pri kirurških bolnikih, še posebej pri tistih z boleznijo srca in ožilja.
In chronic renal failure patients, the half-life of intravenously administered epoetin alfa is slightly prolonged, approximately 5 hours, compared to healthy subjects.
Pri bolnikih s kronično z ledvično odpovedjo je razpolovni čas intravensko danega epoetina alfa v primerjavi z zdravimi osebami nekoliko podaljšan, približno 5 ur.
Urticaria3
Pogostnost urtikarija3
Adults on chemotherapy
Odrasli bolniki na kemoterapiji
In case of larger volumes, more than one site should be chosen for the injection.
V primeru večjih količin je treba zdravilo injicirati na več mestih.
Epoetin alfa was administered at 75 IU/kg/week intravenously in 2 or 3 divided doses post-dialysis, titrated by 75 IU/kg/week at intervals of 4 weeks (up to a maximum of 300 IU/kg/week), to achieve a 1 g/dL/month increase in haemoglobin.
Epoetin alfa so dajali v odmerku 75 i.e./kg/teden intravensko, v 2 ali 3 razdeljenih odmerkih po dializi, ki so ga v 4-tedenskih intervalih titrirali po 75 i.e./kg/teden (do največ 300 i.e./kg/teden), za dosego povečanja hemoglobina za 1 g/dl/mesec.
In patients developing sudden lack of efficacy defined by a decrease in haemoglobin (1 to 2 g/dL or 0.62 to 1.25 mmol/L per month) with increased need for transfusions, a reticulocyte count should be obtained and typical causes of non-response (e.g. iron, folate or vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be investigated.
Pri bolnikih, pri katerih se je razvilo nenadno zmanjšanje učinka zdravila, ki je opredeljeno kot zmanjšanje koncentracije hemoglobina (za 1 do 2 g/dl ali 0,62 do 1,25 mmol/l na mesec) s povečano potrebo po transfuziji, je treba določiti število retikulocitov in raziskati značilne vzroke neodzivnosti na zdravljenje (npr. pomanjkanje železa, folata ali vitamina B12, zastrupitev z aluminijem, okužba ali vnetje, izguba krvi, hemoliza in fibroza kostnega mozga katerega koli izvora).
The recommended dose is Epoetin alfa HEXAL 600 IU/kg, administered subcutaneously weekly for three weeks (days -21, -14 and -7) prior to surgery and on the day of surgery (day 0).
Priporočeni odmerek zdravila Epoetin alfa HEXAL je 600 i.e./kg, ki se daje subkutano tedensko v obdobju treh tednov (na 21., 14. in 7. dan) pred kirurškim posegom in na dan kirurškega posega (dan 0).
Your Epoetin alfa HEXAL dose and frequency of administration may be further adjusted to maintain your response to treatment.
Po potrebi vam lahko odmerek zdravila Epoetin alfa HEXAL in pogostnost uporabe nadalje prilagaja, da se ohrani vaš odziv na zdravljenje.
You may still be able to use Epoetin alfa HEXAL, but discuss it with your doctor first.
Morda boste kljub temu lahko uporabljali zdravilo Epoetin alfa HEXAL, vendar se najprej posvetujte s svojm zdravnikom.
• 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.
• Če uporabljate daljši interval odmerjanja zdravila Epoetin alfa HEXAL (daljši kot enkrat tedensko), morda ne bo mogoče vzdrževati ustrezne ravni hemoglobina in bo treba odmerek ali pogostnost odmerjanja zdravila Epoetin alfa HEXAL povečati.
In order to ensure optimum response to epoetin alfa, adequate iron stores should be assured and iron supplementation should be administered if necessary (see section 4.2):
Za optimalen odziv na zdravljenje z epoetinom alfa je treba zagotoviti ustrezne zaloge železa in po potrebi dajati nadomestke železa (glejte poglavje 4.2):
After single doses (20,000 to 160,000 IU subcutaneously) of epoetin alfa, a dose-dependent response was observed for the pharmacodynamic markers investigated including: reticulocytes, RBCs, and haemoglobin.
Zdravi prostovoljci Po enkratnem odmerjanju (20.000 do 160.000 i.e. subkutano) epoetina alfa so opazili od odmerka odvisen odziv preučevanih farmakodinamičnih markerjev, vključno z retikulociti, RKC in hemoglobinom.
Patients with very low initial haemoglobin (< 6 g/dL or < 3.75 mmol/L) may require higher maintenance doses than patients whose initial anaemia is less severe (> 8 g/dL or > 5 mmol/L).
Bolniki z zelo majhno začetno koncentracijo hemoglobina (< 6 g/dl ali < 3,75 mmol/l) lahko potrebujejo večje vzdrževalne odmerke kot bolniki z blažjo začetno anemijo (> 8 g/dl ali > 5 mmol/l).
The studies either recruited patients who were being treated with chemotherapy (two studies) or used patient populations in which ESAs are not indicated: anaemia in patients with cancer not receiving chemotherapy, and head and neck cancer patients receiving radiotherapy.
(dve študiji), ali bolniki, pri katerih uporaba ESA ni bila indicirana: anemija pri bolnikih z rakom, ki niso prejemali kemoterapije, in bolniki z rakom glave in vratu, ki so prejemali radioterapijo.
If the patient loses response or haemoglobin concentration drops by ≥ 1 g/dL upon dose reduction the dose should be increased by one dosing step.
Če se po zmanjšanju odmerka bolnik ne odziva več ali če koncentracija hemoglobina pade za ≥ 1 g/dl, je treba odmerek povečati za en odmerni korak.
Key baseline characteristics for the < 200 mU/mL stratum are shown in the table below.
Ključne izhodiščne značilnosti skupine < 200 me./ml so prikazane v spodnji preglednici.
The needle safety guard will cover the needle when releasing the plunger.
Varnostna zaščita za iglo bo po sprostitvi bata pokrila iglo.
Hyperkalaemia has been observed in isolated cases though causality has not been established.
V posameznih primerih so opazili pojav hiperkaliemije, vendar smrtnih primerov niso ugotovili.
Chronic renal failure
Kronična ledvična odpoved
Anaphylactic reaction3
občasni anafilaktična reakcija3
The half-life for the subcutaneous route is estimated to be approximately 24 hours in healthy subjects.
Razpolovni čas za subkutano uporabo je pri zdravih osebah približno 24 ur.
In female adult patients with metastatic breast cancer, subcutaneous co-administration of 40,000 IU/mL epoetin alfa with trastuzumab 6 mg/kg had no effect on the pharmacokinetics of trastuzumab.
Pri odraslih bolnicah z metastatskim rakom dojke ni imelo subkutano sočasno dajanje 40.000 i.e./ml epoetina alfa s trastuzumabom 6 mg/kg nobenega učinka na farmakokinetiko trastuzumaba.
Epoetin alfa HEXAL can reduce the need for a blood transfusion in these patients.
Zdravilo Epoetin alfa HEXAL lahko pri teh bolnikih zmanjša potrebo po transfuziji krvi.
Particular attention should be paid to sudden stabbing migraine-like headaches as a possible warning signal (see section 4.4).
Treba je biti pozoren na nenaden pojav migreni podobnih glavobolov z zbadanjem, ki so lahko možen opozorilni znak (glejte poglavje 4.4).
If epoetin alfa is given concomitantly with cyclosporin, blood levels of cyclosporin should be monitored and the dose of cyclosporin adjusted as the haematocrit rises.
Če epoetin alfa dajemo sočasno s ciklosporinom, je treba spremljati koncentracije ciklosporina v krvi in njegov odmerek v primeru zvečanega hematokrita prilagoditi.
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.
Epoetin alfa je treba uporabljati previdno pri bolnikih z epilepsijo, epileptičnimi napadi v anamnezi ali bolezenskimi stanji, povezanimi z nagnjenostjo k epileptični aktivnosti, kot so okužba CŽS in metastaze v možganih.
Following intravenous administration of epoetin alfa in subjects with chronic renal failure, the volume of distribution ranged from 57-107 mL/kg after single dosing (12 IU/kg) to 4264 mL/kg after multiple dosing (48-192 IU/kg), respectively.
Po intravenskem dajanju epoetina alfa osebam s kronično ledvično odpovedjo je bil razpon volumna porazdelitve od 57-107 ml/kg po enkratnem odmerjanju (12 i.e./kg) oz. do 42-64 ml/kg po večkratnem odmerjanju (48-192 i.e./kg).