natgillin/translations-raw huggingface dataset:
Silapo contains a protein called epoetin zeta, that stimulates the bone marrow to produce more red blood cells which carry haemoglobin (a substance that transports oxygen).
Zdravilo Silapo vsebuje beljakovino, imenovano epoetin zeta, ki stimulira kostni mozeg, da tvori več rdečih krvnih celic, ki prenašajo hemoglobin (snov, ki prenaša kisik).
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.
These include: iron, folate, or Vitamin B12 deficiency; aluminium intoxication; intercurrent infections; inflammatory or traumatic episodes; occult blood loss; haemolysis, and bone marrow fibrosis of any origin.
Med njimi so: pomanjkanje železa, folata, vitamina B12; zastrupitev z aluminijem; sočasne okužbe; epizode z vnetji ali travmatične epizode; neopazna izguba krvi; hemoliza in fibroza kostnega mozga iz kakršnegakoli vzroka.
• Feeling sick in your stomach
• Občutek slabosti v želodcu.
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 po zmanjšanju odmerka bolnik postane neodziven ali če koncentracija hemoglobina pade za ≥ 1 g/dl, je treba odmerek povečati za en odmerni korak.
If you are pregnant or breast-feeding, Silapo should be used only if the potential benefit outweighs the potential risk to the foetus.
Če ste noseči ali če dojite, se zdravilo Silapo sme uporabljati samo, če možne koristi pretehtajo možna tveganja za plod.
in moderately anaemic adults about to have major orthopaedic surgery (for example hip or knee replacement operations), to reduce the potential need for blood transfusions.
pri zmerno anemičnih odraslih, naročenih na večji ortopedski kirurški poseg (na primer zamenjava kolka ali kolena), da bi zmanjšali potrebo po transfuziji krvi.
Your doctor will conduct investigations, for example blood tests, to help decide if it is necessary for you to have Silapo.
Vaš zdravnik bo naročil preiskave, na primer krvne test, ki mu pomagajo odločiti, ali potrebujete zdravilo Silapo.
The haemoglobin values should not exceed a value of 12g/dl.
Vrednosti hemoglobina ne smejo preseči 12g/dl.
If signs and symptoms suggestive of these reactions appear, Silapo should be withdrawn immediately and an alternative treatment considered.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 Silapo takoj prekiniti in razmisliti o drugi vrsti zdravljenja.
Talk to your doctor before using Silapo if you know you are suffering, or have suffered, from any of the following: epileptic seizures liver disease cancer anaemia from other causes heart disease (such as angina) disorders of blood circulation resulting in pins and needles or cold hands or feet or muscle cramps in the legs blood clots/blood clotting disorders kidney disease.
Pred začetkom uporabe zdravila Silapo se posvetujte s svojim zdravnikom, če imate ali ste imeli katero od naslednjih bolezni: epileptični napadi bolezen jeter rak anemija iz drugih vzrokov srčna bolezen (kot na primer angina pektoris) motnje krvnega obtoka, zaradi česar čutite mravljince in zbadanje ali mrzle roke in noge ali pa krče v nogah krvni strdki/motnje zaradi strjevanja krvi bolezen ledvic.
Dose increase
Povečanje odmerka
Epoetin alfa was administered subcutaneously for 10 days prior to surgery, on the day of surgery, and for four days after surgery.
Epoetin alfa so dajali subkutano 10 dni pred kirurškim posegom, na dan kirurškega posega in štiri dni po kirurškem posegu.
• increased risk of death when administered to target a haemoglobin of 12 g/dl (7.5 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
• povečanega tveganja smrti pri dajanju omenjenih zdravil, da bi dosegli ciljno koncentracijo hemoglobina, ki znaša 12 g/dl (7,5 mmol/l) pri bolnikih z aktivno maligno boleznijo, ki ne prejemajo kemoterapije niti terapije z obsevanjem.
Under no circumstances should you attempt to inject yourself unless you have been trained to do so.
Če vas v ta namen niso izobrazili, si v nobenem primeru zdravila ne poskušajte injicirati sami.
Silapo can be used to increase haemoglobin concentration in 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 Silapo se lahko uporablja za povečanje koncentracije hemoglobina pri simptomatski anemiji (koncentracija hemoglobina ≤ 10 g/dl) pri odraslih s primarnimi mielodisplastičnimi sindromi (MDS) z nizkim ali srednjim-1 tveganjem, ki imajo nizke ravni eritropoetina v serumu (< 200 mU/ml).
Measurement of erythropoietin following multiple dose intravenous administration revealed a half-life of approximately 4 hours in healthy volunteers and a somewhat more prolonged half-life of approximately 5 hours in renal failure patients.
Pri zdravih prostovoljcih so za eritropoetin, apliciran intravensko v večkratnih odmerkih, izmerili razpolovni čas okoli 4 ur, pri bolnikih z okvaro ledvic pa malce daljši razpolovni čas dolžine približno 5 ur.
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 %) preskušancev brez predhodnih transfuzij v primerjavi s 7/31 (22,6 %) preskušancev s predhodnimi transfuzijami (2 preskušanca s predhodno transfuzijo sta dosegla primarni opazovani dogodek na podlagi absolutnega zmanjšanja števila enot koncentriranih eritrocitov, ki sta jih prejela s transfuzijo, za vsaj 4 enote vsakih 8 tednov v primerjavi z 8 tedni pred izhodiščem).
Afterwards, your doctor may order blood tests to see if any adjustment in dose is required.
Kasneje bo zdravnik morda naročil teste krvi, da vidi, ali je treba prilagoditi odmerek.
Silapo has no or negligible effect on the ability to drive and use machines.
Zdravilo Silapo nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI: 0.99, 1.18; 42 trials and 8 167 patients).
Meta analiza podatkov celotnega preživetja je razkrila oceno točke razmerja tveganja, ki je bila 1,08 v prid kontrolam (95 % CI: 0,99, 1,18; 42 preskušanj in 8 167 bolnikov).
In particular, if you are taking a medicine containing the active substance ciclosporin to suppress your immune system after a kidney transplant, your doctor may order special blood tests to measure ciclosporin levels while you are taking Silapo.
V primeru, da jemljete zdravilo, ki vsebuje zdravilno učinkovino ciklosporin, s katerim se po transplantaciji ledvic zavira imunaki sistem, vam bo zdravnik morda predpisal posebno teste krvi, s katerimi se med jemanjem zdravila Silapo meri koncentracija ciklosporina.
Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.
Poročali so o pojavu eritroblastopenije (PRCA), povzročene s protitelesi, po več mesecih ali letih zdravljenja z epoetinom alfa.
• Redness, burning and pain at the site of injection
• Rdečina, pekoč občutek in bolečina na mestu injiciranja.
These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.
Videti so lahko kot tarčam podobne makule ali okrogle zaplate na trupu s pogostimi mehurčki v njihovem središču, luščenje kože, razjede v ustih, grlu, nosu, na genitalijah in očeh, preden se pojavijo, pa lahko nastopijo zvišana telesna temperatura in gripi podobni simptomi.
A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform antierythropoietin antibody testing.
Paradoksalno zmanšanje koncentracije hemoglobina in pojav hude anemije, povezane z majhnim številom retikulocitov pomeni, da je treba zdravljenje z epoetinom prekiniti takoj in narediti testiranje za protitelesa proti eritropoetinu.
A minimum of 4 weeks should elapse between dose increases.
Med povečanji odmerka morajo preteči vsaj 4 tedni.
After your condition has been brought under control, you will receive regular doses of Silapo (3 times a week, or, if you have your injections under the skin, it may also be given once weekly or once every 2 weeks).
Ko je stanje pod nadzorom, boste trikrat na teden dobivali običajni odmerek zdravila Silapo ali, če si zdravilo injicirate pod kožo, lahko tudi enkrat na teden ali enkrat na dva tedna.
A maximum volume of 1 ml at one injection site should generally not be exceeded.
Na mestu injiciranja se v splošnem ne sme dajati volumen večji kot 1ml.
Correction phase: Starting dose of 50 IU/kg 3 times per week, followed if necessary by a dose 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).
Korekcijska faza: začetni odmerek je 50 i.e./ trikrat tedensko, ki se ga po potrebi veča s koraki po 25 i.e./kg (trikrat tedensko), dokler se ne doseže zadana vrednost (koraki naj si sledijo s presledkom najmanj štirih tednov):
Caution should be exercised with escalation of Silapo 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.
Pri višanju odmerkov zdravila Silapo pri bolnikih s kronično ledvično odpovedjo je potrebna previdnost, ker so kumulativni odmerki epoetina lahko povezani s povečanim tveganjem za smrt ter resne kardiovaskularne in cerebrovaskularne dogodke.
In a prospective, randomised, double-blind, placebo-controlled trial conducted in 375 anaemic patients with various non-myeloid malignancies receiving non-platinum chemotherapy, there was a significant reduction of anaemia-related sequelae (e.g. fatigue, decreased energy, and activity reduction), as measured by the following instruments and scales: Functional Assessment of Cancer Therapy-Anaemia (FACT-An) general scale, FACT-An fatigue scale, and Cancer Linear Analogue Scale (CLAS).
V prospektivnem, randomiziranem, dvojno slepem s placebom kontroliranem preskušanju so pri 375 slabokrvnih bolnikih z različnimi nemieloidnimi malignostmi, ki so prejemali kemoterapijo brez platine, ugotovili signifikantno zmanjšanje z anemijo povezanih posledic (npr. utrujenosti, zmanjšane energije in zmanjšane aktivnosti), kot se jih meri s pomočjo naslednjih instrumentov in meril: splošna merila za funkcionalno oceno terapije raka - anemija (FACT-an - "Functional Assessment of Cancer Therapy-Anaemia"), FACT-an merila utrujenosti, in linearna analogna skala za rak (CLAS - "Cancer Linear Analogue Scale").
Dose (IU/kg given 3 times per week)
Odmerek (i.e./kg 3-krat na teden)
• the blister sealing is broken or the blister is damaged in any way
• če je pečat na ovojnini pretrgan ali če je ovojnina na kakršenkoli način poškodovana
The incidence of bone marrow fibrosis was not increased in a study of haemodialysis patients who were treated with erythropoietin for 3 years compared to a matched control group of dialysis patients who had not been treated with erythropoietin).
V študiji bolnikov na hemodializi se pogostnost fibroze kostnega mozga pri bolnikih, ki so jih tri leta zdravili s eritropoetinom, ni povečala v primerjavi z ustrezno kontrolno skupino, ki je niso zdravili z eritropoetinom).
When your condition has been brought under control, you will receive regular doses of Silapo, 2 or 3 times a week.
Ko je Vaše stanje pod nadzorom, boste dvakrat ali trikrat na teden dobivali običajne odmerke zdravila Silapo.
Silapo is indicated for non-iron deficient adults prior to major elective orthopaedic surgery having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions.
Zdravilo Silapo indicirano pred večjimi elektivnimi ortopedskimi kirurškimi posegi pri odraslih brez pomanjkanja železa, pri katerih obstaja veliko tveganje za zaplete pri transfuziji, za zmanjšanje izpostavljenosti alogenim transfuzijam krvi.
Silapo must not be administered by intravenous infusion.
Zdravilo Silapo se ne sme dajati z intravenozno infuzijo.
Your doctor will order regular blood tests to ensure that your medicine is continuing to work properly.
Vaš zdravnik bo redno opravljal preiskave krvi, da preveri, če Vaše zdravilo še naprej pravilno učinkuje.
Remove the syringe from the blister and check that the solution is clear, colourless and practically free from visible particles.
Vzemite injekcijsko brizgo iz ovojnine in se prepričajte, da je raztopina bistra, brezbarvna in praktično brez vidnih delcev.
Use in adult patients in an autologous predonation programme The recommended starting dose is 600 IU/kg.
Odrasli kirurški bolniki v programu darovanja avtologne krvi Priporočeni začetni odmerek je 600 i.e./kg.
The recommended starting dose of Silapo is 50 IU/kg (International Units per kilogram).
Priporočeni začetni odmerek je 50 i.e./kg (mednarodnih enot na kilogram).
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, pri katerih je predviden večji elektivni ortopedski kirurški 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.
Included were 228 epoetin alfa-treated CRF subjects in 4 chronic renal failure studies (2 studies in predialysis [N = 131 exposed CRF subjects] and 2 in dialysis [N = 97 exposed CRF subjects]); 1 404 exposed cancer subjects in 16 studies of anaemia due to chemotherapy; 147 exposed subjects in 2 studies for autologous blood donation; 213 exposed subjects in 1 study in the perisurgical period, and 102 exposed subjects in 2 MDS studies.
Vključenih je bilo 228 preskušancev s kronično ledvično odpovedjo, zdravljenih z epoetinom alfa, v 4 študijah kronične ledvične odpovedi (2 študiji pred dializo [N = 131 izpostavljenih preskušancev s kronično ledvično odpovedjo] in 2 z dializo [N = 97 izpostavljenih preskušancev s kronično ledvično odpovedjo]; 1 404 izpostavljeni preskušanci z rakom v 16 študijah z anemijo, ki je posledica kemoterapije; 147 izpostavljenih preskušancev v 2 študijah z avtolognim darovanjem krvi; 213 izpostavljenih preskušancev v 1 študiji v perioperativnem obdobju in 102 izpostavljena preskušanca v 2 študijah MDS.
Silapo should be administered either under the skin (subcutaneously) or as an injection either into a vein or a tube that goes into a vein.
Zdravilo Silapo se lahko daje pod kožo (subkutano) ali v obliki injekcije v veno ali v cevko, ki vodi v veno.
MedDRA System Organ Classification (SOC)
Organski sistem po klasifikaciji MedDRA
In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see sections 4.2 and 5.1).
Pri bolnikih s slabim odzivom hemoglobina na epoetine je treba razmisliti o možnih drugih razlagah za slab odziv na zdravljenje (glejte poglavji 4.2 in 5.1).
At each step, the increase or reduction in dose should be of 25 IU/kg 3 times per week.
Pri vsakem koraku je treba odmerek zvečati ali zmanjšati za 25 i.e/kg trikrat na teden.
Monitoring of reticulocyte count on a regular basis is recommended to detect possible occurrence of lack of efficacy in chronic renal failure patients.
Priporoča se reden nadzor števila retikulocitov, ker se s tem pri bolnikih s kronično ledvično okvaro lahko ugotovi možna odsotnost učinkovitosti zdravljenja.
If you forget to use Silapo
Če ste pozabili uporabiti zdravilo Silapo
Your doctor will check that your haemoglobin does not exceed a certain level, as high haemoglobin concentrations could put you at risk of having a problemof the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
Vaš zdravnik bo preverjal, da koncentracija vašega hemoglobina ne bo presegla določeneravni, ker lahko velike koncentracije predstavljajo tveganje za nastanek težav s srcem ali ožiljem in lahko povečajotveganje za srčniinfarkt, kap in smrt.
Silapo has a wide safety margin and side effects due to an overdose of using Silapo are unlikely.
Zdravilo Silapo ima veliko varnostno rezervo, tako da neželeni učinki zaradi prevelikega odmerka niso verjetni.
Special warnings
Posebna opozorila
The recommended starting dose of Silapo is 450 IU/kg (maximum total dose is 40 000 IU).
Priporočeni začetni odmerek zdravila Silapo je 450 i.e./kg (največji skupni odmerek je 40 000 i.e.).
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 Silapo.
Zdravniku ali medicinski sestri nemudoma povejte, če opazite kateregakoli od teh neželenih učinkov ali če med zdravljenjem z zdravilom Silapo opazite druge neželene učinke.
in anaemic adult patients with myelodysplastic syndrome to reduce the need for a blood transfusion.
za slabokrvne odrasle bolnike z mielodisplastičnim sindromom, da bi zmanjšali potrebo po transfuziji krvi.
Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin must not receive Silapo or any other erythropoietin (see section 4.4).
Bolniki, pri katerih po zdravljenju s katerimkoli eritropoetinom pride do čiste aplazije rdečih krvnih celic (PRCA - "Pure Red Cell Aplasia"), zdravila Silapo ali kateregakoli drugega eritropoetina ne smejo dobivati (glejte poglavje 4.4).
Treatment of adult patients scheduled for major elective orthopaedic surgery In patients scheduled for major elective orthopaedic surgery with a pretreatment haemoglobin of > 10 to ≤ 13 g/dl, epoetin alfa has been shown to decrease the risk of receiving allogeneic transfusions and hasten erythroid recovery (increased haemoglobin levels, haematocrit levels, and reticulocyte counts).
Zdravljenje odraslih bolnikov, naročenih na večji elektivni ortopedski kirurški poseg Pri bolnikih, ki so naročeni na večji elektivni ortopedski kirurški poseg s hemoglobinom > 10 do ≤ 13 g/dl, je bilo dokazano, da epoetin alfa zmanjša tveganje za prejemanje alogenih transfuzij in pospeši eritroidno okrevanje (povečanje ravni hemoglobina, ravni hematokritov in število retukulocitov).
An open-label, parallel-group trial in non-iron deficient adult subjects with a pretreatment haemoglobin of ≥ 10 to ≤ 13 g/dl who were scheduled for major orthopaedic hip or knee surgery compared epoetin alfa 300 IU/kg subcutaneously daily for 10 days prior to surgery, on the day of surgery and for four days after surgery to epoetin alfa 600 IU/kg subcutaneously once weekly for 3 weeks prior to surgery and on the day of surgery.
V odprtem preskušanju z vzporednimi skupinami pri odraslih osebah brez pomanjkanja železa, predhodno zdravljenih s hemoglobinom ≥ 10 do ≤ 13 g/dl, ki so imeli načrtovan večji ortopedski kirurški poseg na kolku ali kolenu, so primerjali epoetin alfa 300 i.e./kg, subkutano, vsak dan, 10 dni pred kirurškim posegom, na dan kirurškega posega in štiri dni po kirurškem posegu, z epoetinom alfa 600 i.e./kg, subkutano, enkrat na teden, 3 tedne pred kirurškim posegom in na dan kirurškega posega.
The rate of increase in haemoglobin should be approximately 1 g/dl (0.62 mmol/l) per month and should not exceed 2 g/dl (1.25 mmol/l) per month to minimise the risk of developing or worsening of hypertension.
Hitrost, s katero se dviga hemoglobin, naj bi bila približno 1g/dl (0,62 mmol/l) na mesec in naj ne bi presegala 2g/dl (1,25 mmol/l) na mesec, da se zmanjša tveganje za razvoj ali poslabšanje hipertenzije.
Use in adult patients with kidney disease but not receiving dialysis The recommended starting dose is 50 IU/kg.
Uporaba pri odraslih bolnikih z boleznijo ledvic, ki niso na dializi Priporočeni začetni odmerek je 50 i.e./kg.
In a randomised, double-blind, placebo-controlled study of 4 038 CRF patients not on dialysis with type 2 diabetes and haemoglobin levels ≤ 11 g/dl, patients received either treatment with darbepoetin alfa to target haemoglobin levels of 13 g/dl or placebo (see section 4.4).
V randomizirani, dvojno slepi, s placebom nadzorovani študiji pri 4 038 bolnikih s kronično ledvično odpovedjo, ki niso potrebovali dialize, vendar so imeli sladkorno bolezen tipa 2 in koncentracijo hemoglobina ≤ 11 g/dL, so bolniki prejemali zdravljenje z darbepoetinom alfa za doseganje ciljnih koncentracij hemoglobina 13 g/dl ali placebo (glejte poglavje 4.4).
Adult patients with low- or intermediate-1-risk MDS
Odrasli bolniki z MDS z nizkim ali srednjim-1 tveganjem
At the start of your therapy, Silapo is injected by medical or nursing staff.
Ob začetku Vaše terapije vam bodo zdravilo Silapo injicirali medicinske sestre ali zdravnik.
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 preseči 150 i.e./kg 3 krat na teden, 240 i.e./kg (do največ 20 000 i.e.) enkrat tedensko ali 480 i.e./kg (do največ 40 000 i.e.) enkrat na dva tedna.
There is an increased risk for thromboembolic events in patients with cancer treated with recombinant human erythropoietin and a negative impact on overall survival cannot be excluded.
Pri bolnikih z rakom, ki prejemajo rekombinantni humani eritropoetin, obstaja povečano tveganje za tromboembolijske dogodke, negativnega vpliva na skupno preživetje pa ni mogoče izključiti.
In order to ensure optimum response to erythropoietin, adequate iron stores should be assured: iron supplementation, e.g. 200-300 mg/day orally (100-200 mg/day for paediatric patients) is recommended for chronic renal failure patients whose serum ferritin levels are below 100 ng/ml oral iron substitution of 200-300 mg/day is recommended for all cancer patients whose transferrin saturation is below 20%.
Da je odziv na eritropoetin optimalen, je treba poskrbeti za ustrezne zaloge železa: dodajanje železa, npr. 200-300 mg na dan peroralno (100-200 mg na dan za pediatrične bolnike) se priporoča za bolnike s kronično okvaro ledvic, ki imajo nivoje feritina v serumu pod 100 ng/ml.
Phenylalanine may be harmful for patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Fenilalanin lahko škoduje bolnikom s fenilketonurijo, redko genetsko boleznijo pri kateri pride do kopičenja fenilalanina, ker se ne more ustrezno odstranjevati iz telesa.
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: o Treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis (see section 4.4).
Zdravljenje simptomatske anemije, povezane s kronično okvaro ledvic pri odraslih in pediatričnih bolnikih: o zdravljenje anemije pri odraslih in pediatričnih bolnikih s kronično okvaro ledvic na hemodializi ali odraslih bolnikov na peritonealni dializi (glejte poglavje 4.4).
Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e.g. stenoses, aneurysms, etc.).
Pojavi se lahko tromboza arteriovenskega spoja (šanta), še posebej pri bolnikih, ki so nagnjeni k hipotenziji, ali tistih, pri katerih se na arteriovenskih fistulah kažejo zapleti (npr. stenoze, anevrizme).