natgillin/translations-raw huggingface dataset:
Your doctor has carried out blood tests and decided you need Epoetin alfa HEXAL.
Vaš zdravnik je opravil krvne preiskave in odločil, da potrebujete zdravilo Epoetin alfa HEXAL.
For the purpose of ambulatory use, the medicinal product may be taken out of the refrigerator, without being replaced, for a maximum period of 3 days at a temperature not above 25°C.
Pri ambulantnem zdravljenju se lahko zdravilo vzame iz hladilnika in je zunaj njega največ 3 dni pri temperaturi do 25 °C.
In animal studies, epoetin alfa has been shown to decrease foetal body weight, delay ossification and increase foetal mortality when given in weekly doses of approximately 20 times the recommended human weekly dose.
Študije na živalih so pokazale, da epoetin alfa zmanjšuje telesno maso plodov, upočasni osifikacijo in poveča umrljivost plodov, če se zdravilo daje v tedenskih odmerkih, ki so približno 20-krat večji od tedenskih odmerkov, priporočenih za ljudi.
PRCA means the bone marrow does not make enough red blood cells.
PRCA pomeni, da v kostnem mozgu ne nastaja zadostno število rdečih krvnih celic.
In 2 studies with extended interval dosing of epoetin alfa (3 times per week, once weekly, once every 2 weeks, and once every 4 weeks) some patients with longer dosing intervals did not maintain adequate haemoglobin levels and reached protocol-defined haemoglobin withdrawal criteria (0% in once weekly, 3.7% in once-every-2-weeks, and 3.3% in the once-every-4-weeks groups).
V 2 študijah s podaljšanim intervalom odmerjanja epoetina alfa (3-krat na teden, enkrat na teden, enkrat na vsaka 2 tedna in vsake 4 tedne) nekateri bolniki z daljšimi intervali odmerjanja niso ohranili ustreznih ravni hemoglobina in so dosegli v protokolu opredeljene kriterije za umik iz študije zaradi hemoglobina (0 % za skupino enkrat na teden, 3,7 % za skupino enkrat na vsaka 2 tedna in 3,3 % za skupino enkrat na vsake 4 tedne).
In most cases, the ferritin values in the serum fall simultaneously with the rise in packed cell volume.
Večinoma se vrednosti feritina v serumu zmanjšajo sočasno z zvečanjem hematokrita.
The percentage of subjects who were transfused in the epoetin alfa group decreased from 51.8% in the 8 weeks prior to baseline to 24.7% between weeks 16 and 24, compared to the placebo group which had an increase in transfusion rate from 48.9% to 54.1% over the same time periods.
Odstotek oseb, ki so prejele transfuzijo, iz skupine, ki je prejemala epoetin alfa, se je zmanjšal z 51,8 % pri 8 tednih pred izhodiščem na 24,7 % v času med 16. in 24. tednom, v primerjavi s skupino, ki je prejemala placebo, pri kateri se je stopnja transfuzije v istem obdobju povečala z 48,9 % na 54,1 %.
Overall, based on the results of these pharmacodynamic studies in healthy subjects, the 40,000 IU once-weekly dosing regimen seems to be more efficient in producing RBCs than the biweekly regimens despite an observed similarity in reticulocyte production in the once-weekly and biweekly regimens.
Na podlagi rezultatov teh farmakodinamičnih študij z zdravimi osebami na splošno kaže, da je režim odmerjanja 40.000 i.e. enkrat na teden bolj učinkovit pri nastajanju RKC kot režim enkrat na dva tedna, kljub opaženi podobnosti pri nastajanju retikulocitov v režimih enkrat na teden in enkrat na dva tedna.
- Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive Epoetin alfa HEXAL or any other erythropoietin (see section 4.4).
- Bolniki, pri katerih se po zdravljenju s katerim koli eritropoetinom razvije aplazija rdečih krvnih celic (PRCA - pure red cell aplasia), ne smejo dobivati zdravila Epoetin alfa HEXAL ali katerega koli drugega eritropoetina (glejte poglavje 4.4).
4.3 Contraindications - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
• If you are having dialysis treatment when you begin treatment with Epoetin alfa HEXAL, your dialysis regime may need to be adjusted.
• Če se zdravite z dializo, ko se začenjate zdraviti z zdravilom Epoetin alfa HEXAL, bo morda treba prilagoditi vaš režim dialize.
25.2 micrograms 33.6 micrograms 42.0 micrograms 50.4 micrograms 58.8 micrograms 67.2 micrograms 75.6 micrograms 84.0 micrograms
25,2 mikrogramov 33,6 mikrogramov 42,0 mikrogramov 50,4 mikrogramov 58,8 mikrogramov 67,2 mikrogramov 75,6 mikrogramov 84,0 mikrogramov
Administration of single doses of 300 to 2,400 IU/kg subcutaneous epoetin alfa resulted in a linear relationship between mean Cmax and dose and between mean AUC and dose.
Dajanje enojnih odmerkov 300 do 2.400 i.e./kg epoetina alfa subkutano je povzročilo linearno razmerje med povprečnim Cmax in odmerkom in med povprečnim AUC in odmerkom.
In the three largest clinical trials conducted in adult patients on dialysis, the median maintenance dose necessary to maintain the haematocrit between 30 to 36% was approximately 75 IU/kg given 3 times per week.
V treh največjih kliničnih preskušanjih, izvedenih z odraslimi bolniki na dializi, je bil mediani vzdrževalni odmerek, potreben za ohranjanje hematokrita med 30 in 36 %, približno 75 i.e./kg trikrat na teden.
During the maintenance phase, Epoetin alfa HEXAL can be administered either 3 times per week, and in the case of subcutaneous administration, once weekly or once every 2 weeks.
Med vzdrževalno fazo se lahko zdravilo Epoetin alfa HEXAL daje bodisi 3-krat na teden ali v primeru subkutanega dajanja enkrat na teden ali enkrat na dva tedna.
• You will usually continue Epoetin alfa HEXAL treatment for one month after the end of chemotherapy.
• Običajno boste zdravilo Epoetin alfa HEXAL dobivali še en mesec po končanem zdravljenju s kemoterapijo.
Because Epoetin alfa HEXAL stimulates the production of red blood cells, doctors can take more blood from these people.
Ker zdravilo Epoetin alfa HEXAL spodbuja nastajanje rdečih krvnih celic, lahko zdravnik od teh ljudi vzame več krvi.
In 5 small, open label, uncontrolled studies (number of patients ranged from 9-22, total N = 72), Epoetin alfa has been administered subcutaneously in children at starting doses of 100 IU/kg/week to 150 IU/kg/week with the possibility to increase up to 300 IU/kg/week.
V 5 majhnih, odprtih, nenadzorovanih študijah (število bolnikov je bilo od 9 do 22, skupaj n = 72), so epoetin alfa otrokom dajali subkutano z začetnimi odmerki 100 i.e./kg/teden do 150 i.e./kg/teden z možnostjo povečanja do 300 i.e./kg/teden.
If Epoetin alfa HEXAL is injected under the skin (subcutaneously), the amount injected is not normally more than one millilitre (1 mL) in a single injection.
Če se zdravilo Epoetin alfa HEXAL injicira pod kožo (subkutano), se z eno injekcijo navadno ne injicira količina, večja kot en mililiter zdravila (1 ml).
Additionally, cerebrovascular accidents (including cerebral infarction, cerebral haemorrhage and transient ischaemic attacks) have been reported.
Dodatno so poročali o cerebrovaskularnih dogodkih (vključno s cerebralnim infarktom, cerebralno krvavitvijo in prehodnimi ishemičnimi napadi).
Erythroid response during the first 24 weeks of the study was demonstrated by 27/85 (31.8%) of the subjects in the epoetin alfa group compared to 2/45 (4.4%) of the subjects in the placebo group (p < 0.001).
Eritroidni odziv v prvih 24 tednih študije so dokazali pri 27/85 (31,8 %) oseb iz skupine, ki je prejemala epoetin alfa, v primerjavi z 2/45 (4,4 %) oseb iz skupine, ki je prejemala placebo (p < 0,001).
Patients were assigned to epoetin alfa treatment targeting a maintenance haemoglobin level of 13.5 g/dL (higher than the recommended haemoglobin concentration level) or 11.3 g/dL.
Bolniki so bili dodeljeni za zdravljenje z epoetinom alfa s ciljem ohranjanja ravni hemoglobina 13,5 g/dl (višje, kot je priporočena raven koncentracije hemoglobina) ali 11,3 g/dl.
Comparable intensity of chemotherapy in the epoetin alfa and placebo groups in the chemotherapy trials was demonstrated by a similar area under the neutrophil time curve in patients treated with epoetin alfa and placebo-treated patients, as well as by a similar proportion of patients in groups treated with epoetin alfa and placebo-treated groups whose absolute neutrophil counts fell below 1,000 and 500 cells/µL.
Primerljiva intenzivnost kemoterapije v skupini z epoetinom alfa in v skupini s placebom v preskušanjih s kemoterapijo je bila dokazana s podobno površino pod krivuljo števila nevtrofilcev v odvisnosti od časa pri bolnikih, zdravljenih z epoetinom alfa, in pri bolnikih, ki so dobivali placebo, kot tudi s podobnim deležem bolnikov v skupinah, zdravljenih z epoetinom alfa in s placebom, katerih absolutno število nevtrofilcev je padlo pod 1.000 in 500 celic/µl.
- increased risk of death when administered to achieve a haemoglobin concentration level of 12 g/dL (7.5 mmol/L) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
- povečano tveganje za smrt, kadar so prejemali odmerke za doseganje ravni koncentracije hemoglobina 12 g/dl (7,5 mmol/l), pri bolnikih z aktivno maligno boleznijo, ki niso prejemali kemo- ali radioterapije.
Inject the Epoetin alfa HEXAL solution as you have been shown by your doctor.
Injicirajte raztopino zdravila Epoetin alfa HEXAL, kot vam je pokazal zdravnik.
- The active substance is: epoetin alfa (for quantity see the table below).
- Učinkovina: epoetin alfa (količine so razvidne iz spodnje preglednice).
An inverse relationship between apparent clearance and dose was noted in healthy subjects.
Pri zdravih osebah so opazili inverzno razmerje med navideznim očistkom in odmerkom.
When this access (via a vein or tube) is not readily available, your doctor may decide that Epoetin alfa HEXAL should be injected under the skin (subcutaneously).
Kadar takšen dostop (v veno ali cevko) ni takoj na razpolago, se vaš zdravnik lahko odloči, da je treba zdravilo Epoetin alfa HEXAL injicirati pod kožo (subkutano).
• Your doctor will maintain your haemoglobin level between 10 and 12 g/dL as a high haemoglobin level may increase the risk of blood clots and death.
• Vaš zdravnik bo ohranjal raven hemoglobina med 10 in 12 g/dl, saj lahko visoka raven hemoglobina poveča tveganje za nastanek krvnih strdkov in smrt.
MedDRA System Organ Classification (SOC)
Razvrstitev organskih sistemov po klasifikaciji MedDRA
The maximum dosage should not exceed 150 IU/kg, 3 times per week, 240 IU/kg (up to a maximum of 20,000 IU) once weekly, or 480 IU/kg (up to a maximum of 40,000 IU) once every 2 weeks.
Največji odmerek ne sme presegati 150 i.e./kg, 3-krat na teden, 240 i.e./kg (do največ 20.000 i.e.) enkrat na teden ali 480 i.e./kg (do največ 40.000 i.e.) enkrat na dva tedna.
A bone marrow examination should also be considered for diagnosis of PRCA.
Za diagnozo PRCA je treba razmisliti o preiskavi kostnega mozga.
Epoetins are growth factors that primarily stimulate red blood cell production.
Epoetini so rastni faktorji, ki primarno spodbujajo tvorbo rdečih krvnih celic.
• Epoetin alfa HEXAL is given by injection into a vein immediately after you have donated blood for 3 weeks before your surgery.
• Zdravilo Epoetin alfa HEXAL se injicira v veno takoj po tem, ko darujete kri, 3 tedne pred kirurškim posegom.
Your doctor will help you to decide if Epoetin alfa HEXAL is suitable for you.
Vaš zdravnik vam bo pomagal pri odločitvi, ali je zdravilo Epoetin alfa HEXAL za vas primerno.
If you are taking a medicine called cyclosporin (used e.g. after kidney transplants), your doctor may order blood tests to check the level of cyclosporin while you are taking Epoetin alfa HEXAL.
Če med zdravljenjem z zdravilom Epoetin alfa HEXAL jemljete zdravilo, imenovano ciklosporin (uporablja se npr. po presaditvi ledvic), lahko zdravnik naroči preiskave krvi, da preveri raven ciklosporina, medtem ko uporabljate zdravilo Epoetin alfa HEXAL.
• Bone or muscle pain.
• Bolečine kosti ali mišic.
If signs and symptoms suggestive of these reactions appear, Epoetin alfa HEXAL should be withdrawn immediately and an alternative treatment considered.
Če se pojavijo znaki in simptomi, ki kažejo na te reakcije, je treba zdravljenje z zdravilom Epoetin alfa HEXAL takoj prekiniti in razmisliti o drugi vrsti zdravljenja.
Epoetin alfa HEXAL is given alone and not mixed with other liquids for injection.
Zdravilo Epoetin alfa HEXAL se daje samo in se ne meša z drugimi tekočinami za injiciranje.
There are no studies assessing the potential effect of epoetin alfa on male or female fertility.
Plodnost Ni študij, s katerimi bi ocenili možen vpliv epoetina alfa na plodnost pri moških ali ženskah.
Patients should be monitored closely to ensure that the lowest approved dose of erythropoiesis-stimulating agent (ESA) is used to provide adequate control of the symptoms of anaemia.
Bolnike je treba skrbno spremljati, da se zagotovi uporaba najmanjšega odobrenega odmerka zdravila za stimulacijo eritropoeze (ESA - erythropoiesis stimulating agent) za doseganje ustreznega nadzora simptomov anemije.
Based on information available to date, correction of anaemia with epoetin alfa in adult patients with renal insufficiency not yet undergoing dialysis does not accelerate the rate of progression of renal insufficiency.
Na osnovi razpoložljivih podatkov korigiranje anemije z epoetinom alfa pri odraslih bolnikih z ledvično insuficienco, ki se še ne zdravijo z hemodializo, ne pospeši hitrosti napredovanja ledvične insuficience.
40,000 IU/mL:
40.000 i.e./ml:
2,000 IU/mL:
2.000 i.e./ml:
If you can't take medicines that prevent blood clotting, you must not have Epoetin alfa HEXAL.
Če ne smete jemati zdravil za preprečevanje nastanka krvnih strdkov, zdravila Epoetin alfa HEXAL ne smete uporabljati.
Some patients with more extended dosing intervals (greater than once weekly) of epoetin alfa may not maintain adequate haemoglobin levels (see section 5.1) and may require an increase in epoetin alfa dose.
Pri nekaterih bolnikih z daljšimi intervali odmerjanja epoetina alfa (daljšimi kot enkrat tedensko) morda ne bo mogoče vzdrževati ustrezne ravni hemoglobina (glejte poglavje 5.1) in bo treba odmerek epoetina alfa povečati.
A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin alfa and perform anti-erythropoietin antibody testing.
Pri paradoksalnem znižanju ravni hemoglobina in razvoju hude anemije, povezane z nizkim številom retikulocitov, je treba prekiniti zdravljenje z epoetinom alfa in opraviti preiskave za protitelesa proti eritropoetinu.
All TVEs occurred in the epoetin alfa group and in the first 24 weeks of the study.
TVE so se pojavili v skupini, zdravljeni z epoetinom alfa, in sicer v prvih 24 tednih študije.
The aim of treatment is to maintain your haemoglobin level between 10 and 12 g/dL as a higher haemoglobin level may increase the risk of blood clots and death.
Cilj zdravljenja je ohranjati raven hemoglobina med 10 in 12 g/dl, saj višje ravni hemoglobina lahko povečajo tveganje za krvne strdke in smrt.
Once the haemoglobin level is < 11 g/dL the dose can be restarted on the same dosing step or one dosing step down based on physician judgement.
< 11 g/dl, se zdravljenje lahko ponovno začne z enakim odmerkom ali za en korak manjšim odmerkom, kot presodi zdravnik.
• Only use Epoetin alfa HEXAL if it has been stored correctly - see section 5, How to store
• Uporabljajte le pravilno shranjeno zdravilo Epoetin alfa HEXAL - glejte poglavje 5,
- an observed 9% increase in risk for progress of disease (PD) or death in the epoetin alfa plus SOC group from a primary analysis and a 15% increased risk that cannot be statistically ruled out in patients with metastatic breast cancer receiving chemotherapy when administered to achieve a haemoglobin concentration range of 10 to 12 g/dL (6.2 to 7.5 mmol/L).
- opaženo 9-odstotno povečanje tveganja za napredovanje bolezni ali smrt v skupini z epoetinom alfa in standardno nego iz primarne analize in 15-odstotno povečanje tveganja, ki ga ni mogoče statistično izključiti pri bolnicah z metastatskim rakom dojke, ki so prejemale kemoterapijo, kadar so prejemale odmerke za doseganje razpona koncentracije hemoglobina od 10 do 12 g/dl (6,2 do 7,5 mmol/l).
What Epoetin alfa HEXAL is and what it is used for What you need to know before you use Epoetin alfa HEXAL How to use Epoetin alfa HEXAL Possible side effects
Kaj je zdravilo Epoetin alfa HEXAL in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Epoetin alfa HEXAL Kako uporabljati zdravilo Epoetin alfa HEXAL
In that stratum, 20/40 (50%) subjects without prior transfusions demonstrated erythroid response during the first 24 weeks, compared with 7/31 (22.6%) subjects with prior transfusions (two subjects with prior transfusion reached primary endpoint based on 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).
V tej skupini so eritroidni odziv v prvih 24 tednih dokazali pri 20/40 (50 %) oseb brez predhodnih transfuzij, v primerjavi s 7/31 (22,6 %) oseb s predhodnimi transfuzijami (dve osebi s predhodno transfuzijo sta dosegli primarni opazovani dogodek na podlagi absolutnega zmanjšanja števila enot RKC, ki sta jih prejeli s transfuzijo, za vsaj 4 enote vsakih 8 tednov v primerjavi z 8 tedni pred izhodiščem).
1 Common in dialysis 2 Includes arterial and venous, fatal and non fatal events, such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, arterial thrombosis (including myocardial infarction), cerebrovascular accidents (including cerebral infarction and cerebral haemorrhage) transient ischaemic attacks, and shunt thrombosis (including dialysis equipment) and thrombosis within arteriovenous shunt aneurisms 3 Addressed in the subsection below and/or in section 4.4
2 Vključuje arterijske in venske dogodke, s smrtnim izidom in brez njega, kot so globoka venska tromboza, pljučna embolija, tromboza mrežnice, arterijska tromboza (vključno z miokardnim infarktom), cerebrovaskularne dogodke (vključno s cerebralnim infarktom in cerebralno krvavitvijo), prehodne ishemične napade in trombozo šanta (vključno z dializno opremo) in trombozo v arteriovenskih anevrizmah šanta 3 Opisano v spodnjem podpoglavju in/ali v poglavju 4.4
Epoetin alfa has been studied in clinical trials in adult anaemic cancer patients with lymphoid and solid tumors, and patients on various chemotherapy regimens, including platinum and non-platinum-containing regimens.
Epoetin alfa so preučili v kliničnih preskušanjih pri odraslih anemičnih bolnikih z rakom z limfoidnimi in solidnimi tumorji in pri bolnikih na različnih režimih kemoterapije, vključno z režimi, ki vključujejo platino in tistimi, ki ne vključujejo platine.
If you are a patient with chronic renal failure, and particularly if you do not respond properly to Epoetin alfa HEXAL, your doctor will check your dose of Epoetin alfa HEXAL because repeatedly increasing your dose of Epoetin alfa HEXAL if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
Če ste bolnik s kronično ledvično odpovedjo, še zlasti, če se na zdravilo Epoetin alfa HEXAL ne odzivate ustrezno, bo zdravnik preveril vaš odmerek zdravila Epoetin alfa HEXAL, saj lahko stalno zviševanje vašega odmerka zdravila Epoetin alfa HEXAL, če se na zdravljenje ne odzivate, poveča tveganje za težave s srcem ali ožiljem in tudi tveganje za srčni infarkt, možgansko kap in smrt.
Dose increase: Dose should not be increased over the maximum of 1050 IU/kg (total dose 80,000 IU)
Povečanje odmerka: odmerka ne smemo povečati toliko, da bi presegel največji odmerek 1050 i.e./kg (skupni odmerek 80.000 i.e.) na teden.
A defined concentration-time profile with peak and return to baseline was observed for changes in percent reticulocytes.
Opazili so definiran profil koncentracije v odvisnosti od časa z vrhom in upadom nazaj na izhodišče za odstotne spremembe retikulocitov.
• have severe disorders of the veins and arteries
• imate hude motnje ven ali arterij
After injecting the liquid, remove the needle while maintaining pressure on the plunger and then let go of your skin.
Ko ste raztopino vbrizgali, iglo izvlecite med tem ko še vedno ohranjate pritisk na bat, nato pa kožo izpustite.
The recommended maintenance dose is between 25 IU/kg and 50 IU/kg, 2 times per week in 2 equal injections.
Priporočeni vzdrževalni odmerek je med 25 i.e./kg in 50 i.e./kg, 2-krat na teden, v dveh enakih injekcijah.
In children the haemoglobin level should be maintained between 9.5 and 11 g/dL.
Pri otrocih se mora raven hemoglobina vzdrževati med 9,5 in 11 g/dl.
In all patients, haemoglobin levels should be closely monitored due to a potential increased risk of thromboembolic events and fatal outcomes when patients are treated at haemoglobin levels above the concentration range for the indication of use.
Pri vseh bolnikih je treba skrbno nadzirati ravni hemoglobina zaradi možnega povečanega tveganja trombemboličnih dogodkov in smrtnega izida pri bolnikih, ki se zdravijo z ravnmi hemoglobina, ki presegajo razpon koncentracije za posamezno indikacijo.
In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
V odprti študiji ni bilo razlike pri splošnem preživetju bolnikov, ki so prejemali rekombinantni humani eritropoetin ali kontrolno skupino.
In the randomised, double-blind, placebo-controlled, multicentre study 4 (4.7%) subjects experienced TVEs (sudden death, ischaemic stroke, embolism, and phlebitis).
V randomizirani, dvojno slepi, s placebom nadzorovani multicentrični študiji je pri 4 (4,7%) osebah prišlo do trombotičnih žilnih dogodkov (TVE) (nenadna smrt, ishemična kap, embolija in flebitis).
The reported risk of these TVEs should be carefully weighed against the benefits to be derived from treatment with epoetin alfa particularly in patients with pre-existing risk factors for TVE, including obesity and prior history of TVEs (e.g. deep venous thrombosis, pulmonary embolism, and cerebral vascular accident).
Poročano tveganje za te TVE je treba skrbno pretehtati glede na pričakovano korist zdravljenja z epoetinom alfa, predvsem pri bolnikih z obstoječimi dejavniki tveganja za TVE, vključno z debelostjo in TVE v anamnezi (npr. globoka venska tromboza, pljučna embolija in cerebrovaskularni dogodki).
Your doctor will check on this.
To bo nadziral vaš zdravnik.
In patients with a poor haemoglobin response to Epoetin alfa HEXAL, alternative explanations for the poor response should be considered (see section 4.4 and 5.1).
Pri bolnikih s slabim odzivom hemoglobina na zdravilo Epoetin alfa HEXAL je treba iskati druge razlage za slab odziv (glejte poglavji 4.4 in 5.1).
Moreover, epoetin alfa doses of 75 to 150 IU/kg per week have been shown to maintain haematocrits of 36 to 38% for up to six months.
Pokazalo se je tudi, da epoetin alfa v odmerkih 75 do 150 i.e./kg na teden ohranja hematokrite na vrednostih od 36 do 38 % do šest mesecev.
If you visit a hospital, clinic or family doctor, tell them you are having Epoetin alfa HEXAL treatment.
Če obiščete bolnišnico, kliniko ali izbranega zdravnika, povejte, da se zdravite z zdravilom Epoetin alfa HEXAL.
Tell your doctor or nurse immediately if you are aware of any of these effects, or if you notice any other effects while you are receiving treatment with Epoetin alfa HEXAL.
Zdravniku ali medicinski sestri takoj povejte, če ugotovite katerega koli od teh neželenih učinkov ali če med zdravljenjem z zdravilom Epoetin alfa HEXAL opazite druge neželene učinke.
Caution should be exercised with escalation of Epoetin alfa HEXAL doses in patients with chronic renal failure since high cumulative epoetin doses may be associated with an increased risk of mortality, serious cardiovascular and cerebrovascular events.
Previdnost je potrebna pri stopnjevanju odmerkov zdravila Epoetin alfa HEXAL pri bolnikih s kronično ledvično odpovedjo, saj so morda višji kumulativni odmerki epoetina povezani s povečanim tveganjem za umrljivost, resne kardiovaskularne in cerebrovaskularne dogodke.