FrancophonIA/ELRC3.0 huggingface dataset:
English: You will receive Silapo during the 3 weeks before your surgery.
Slovenian: Zdravilo Silapo boste dobivali tri tedne pred operacijo.
English: Tell your doctor or nurse immediately if you notice any of the effects in this list.
Slovenian: Takoj obvestite svojega zdravnika ali medicinsko sestro, če opazite katerega koli izmed naštetih učinkov.
English: Treatment of adult patients with low- or intermediate-1-risk MDS
Slovenian: Zdravljenje odraslih bolnikov z MDS z nizkim ali srednjim-1 tveganjem
English: Erythropoietin did not show any changes in bacterial and mammalian cell culture mutagenicity tests and an in vivo micronucleus test in mice.
Slovenian: Eritropoetin v testih mutagenosti na kulturah bakterij in sesalskih celic ni pokazal nobenih sprememb, ravno tako ne v mikrojedrskem testu na miših.
English: Mildly anaemic patients (haematocrit of 33-39%) requiring predeposit of ≥ 4 units of blood should be treated with Silapo at a dose of 600 IU/kg body weight 2 times weekly for 3 weeks prior to surgery.
Slovenian: Blago anemičnim bolnikom (hematokrit 33-39%), ki potrebujejo zalogo ≥ 4 enot krvi, je treba dajati zdravilo Silapo v odmerku 600 i.e./kg telesne mase dvakrat tedensko, 3 tedne pred operacijo.
English: When a dose adjustment is necessary, this should be done in steps of 25 IU/kg, 3 times per week at intervals of at least 4 weeks until the desired goal is achieved.
Slovenian: Kadar je potrebno spremeniti odmerek, je treba spremembo izvesti v korakih po 25 i.e./ kg, 3 krat na teden s presledki najmanj 4 tednov, dokler se ne doseže zadana vrednost.
English: SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Slovenian: SJS/TEN je sprva lahko videti kot rdečkaste, tarčam podobne lise ali okrogle zaplate na trupu s pogostimi mehurčki v njihovem središču.
English: Tumour growth potential
Slovenian: Možnost za rast tumorja
English: The recommended total weekly dose is between 75 and 300 IU/kg.
Slovenian: Priporočen tedenski odmerek je med 75 in 300 i.e/kg.
English: In case Silapo is injected under the skin (subcutaneously) you can also inject the solution yourself once you have been shown how.
Slovenian: Če se zdravilo Silapo injicira pod kožo (subkutano), si lahko injekcije dajete tudi sami, ko vam pokažejo kako.
English: If this occurs it can result in severe anaemia, the symptoms of which are unusual tiredness, feeling dizzy or breathlessness.
Slovenian: Če pride do tega, je posledica resna anemija, s simptomi, kot so neobičajna utrujenost, vrtoglavica in pomanjkanje sape.
English: 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.
Slovenian: Ko je raven hemoglobina < 11 g/dl, lahko nadaljujete zdravljenje z enakim odmerkom ali za en korak manjšim odmerkom, odvisno od presoje zdravnika.
English: Keep the pre-filled syringe in the outer carton in order to protect from light.
Slovenian: Napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: The following reactions have also occurred in isolated patients with normal or low blood pressure: hypertensive crisis with encephalopathy-like symptoms (e.g. headaches and confused state) and generalised tonoclonal seizures, requiring the immediate attention of a physician and intensive medical care.
Slovenian: Pri posameznih bolnikih z normalnim ali nizkim krvnim tlakom so se pojavile naslednje reakcije: hipertenzivna kriza s simptomi, podobnimi encefalopatiji (npr. glavoboli, stanje zmedenosti), in generalizirani tonično-klonični epileptični napadi, pri katerih je potrebna takojšnja zdravniška pomoč in intenzivna zdravstvena nega.
English: • the liquid is coloured or you can see particles floating in it
Slovenian: • če je tekočina obarvana ali če je videti v njej plavati delce
English: Alternatively, the injection can be given at the end of the dialysis session via the fistula needle tubing, followed by 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection to rinse the tubing and ensure satisfactory injection of the medicinal product into the circulation.
Slovenian: Injiciranje se lahko opravi tudi ob koncu dialize skozi arteriovensko fistulo, ki mu sledi injiciranje natrijevega klorida 9 mg/ml (0,9%) raztopine za injiciranje, da se cevke splaknejo in da se zagotovi zadovoljiv vnos zdravila v obtok.
English: In patients developing sudden lack of efficacy, defined by a decrease in haemoglobin (1-2 g/dl 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, and haemolysis) should be investigated.
Slovenian: Pri bolnikih, pri katerih pride nenadoma do zmanjšanja učinkovitosti, definiranega kot zvišanje hemoglobina (1-2 g/dl na mesec) ob povečani potrebi po transfuzijah, je treba izmeriti število retikulocitov in raziskati tipične vzroke za zmanjšanje učinkovitosti (npr. pomanjkanje železa, folata, vitamina B12, zastrupitev z aluminijem, okužbe ali vnetja, izguba krvi in hemoliza).
English: If you stop using Silapo
Slovenian: Če ste prenehali uporabljati zdravilo Silapo
English: Screening sEPO <200 mU/ml (N) Haemoglobin (g/l)
Slovenian: Skupaj (n) sEPO ob presejanju < 200 mU/ml (n) Hemoglobin (g/l)
English: In clinical trials, an increased risk of death, serious cardiovascular events or cerebrovascular events including stroke were observed when ESAs were administered to target a haemoglobin of greater than 12 g/dl (7.5 mmol/l).
Slovenian: V kliničnih preskušanjih so opazili povečano tveganje za smrt, resne kardiovaskularne dogodke ali možganskožilne dogodke, vključno s kapjo, kadar so ESA dajali, da bi dosegli ciljno koncentracijo hemoglobina, ki presega 12 g/dl (7,5 mmol/l).
English: For the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 3 days.
Slovenian: Pri ambulantni uporabi lahko bolnik zdravilo vzame iz hladilnika in ga nato hrani pri sobni temperaturi (do 25 ºC), vendar največ 3 dni.
English: Silapo can be used to increase the yield of autologous blood from patients in a predonation programme.
Slovenian: Zdravilo Silapo se lahko uporablja za povečanje količine avtologne krvi pri bolnikih v programu avtologne transfuzije.
English: Intravenous injection
Slovenian: Intravensko injiciranje
English: • have severe disorders of the veins and arteries
Slovenian: • imate hude motnje ven ali arterij,
English: If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Silapo, treatment with Silapo must not be restarted in this patient at any time.
Slovenian: Če je pri bolniku zaradi uporabe zdravila Silapo prišlo do hude kožne reakcije, kot sta SJS ali TEN, zdravljenja z zdravilom Silapo ni dovoljeno ponovno začeti.
English: Discontinue therapy soon as possible, even several weeks prior to initiating the autologous predeposit, in order to achieve high iron stores prior to starting Silapo therapy.
Slovenian: Z dodajanjem železa je treba začeti čim preje, celo več tednov pred začetkom avtolognega odvzema, da bi tako ob začetku terapije z zdravilom Silapo bolnik imel visoke zaloge železa.
English: 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).
Slovenian: Zdravilo Silapo vsebuje beljakovino, imenovano epoetin zeta, ki stimulira kostni mozeg, da tvori več rdečih krvnih celic, ki prenašajo hemoglobin (snov, ki prenaša kisik).
English: Epoetin alfa 300 IU/kg significantly reduced the risk of allogeneic transfusion in patients with a pretreatment haemoglobin of > 10 to ≤ 13 g/dl.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • Feeling sick in your stomach
Slovenian: • Občutek slabosti v želodcu.
English: 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.
Slovenian: Če po zmanjšanju odmerka bolnik postane neodziven ali če koncentracija hemoglobina pade za ≥ 1 g/dl, je treba odmerek povečati za en odmerni korak.
English: If you are pregnant or breast-feeding, Silapo should be used only if the potential benefit outweighs the potential risk to the foetus.
Slovenian: Če ste noseči ali če dojite, se zdravilo Silapo sme uporabljati samo, če možne koristi pretehtajo možna tveganja za plod.
English: 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.
Slovenian: pri zmerno anemičnih odraslih, naročenih na večji ortopedski kirurški poseg (na primer zamenjava kolka ali kolena), da bi zmanjšali potrebo po transfuziji krvi.
English: Your doctor will conduct investigations, for example blood tests, to help decide if it is necessary for you to have Silapo.
Slovenian: Vaš zdravnik bo naročil preiskave, na primer krvne test, ki mu pomagajo odločiti, ali potrebujete zdravilo Silapo.
English: The haemoglobin values should not exceed a value of 12g/dl.
Slovenian: Vrednosti hemoglobina ne smejo preseči 12g/dl.
English: If signs and symptoms suggestive of these reactions appear, Silapo should be withdrawn immediately and an alternative treatment considered.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Dose increase
Slovenian: Povečanje odmerka
English: Epoetin alfa was administered subcutaneously for 10 days prior to surgery, on the day of surgery, and for four days after surgery.
Slovenian: Epoetin alfa so dajali subkutano 10 dni pred kirurškim posegom, na dan kirurškega posega in štiri dni po kirurškem posegu.
English: • 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.
Slovenian: • 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.
English: Under no circumstances should you attempt to inject yourself unless you have been trained to do so.
Slovenian: Če vas v ta namen niso izobrazili, si v nobenem primeru zdravila ne poskušajte injicirati sami.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Afterwards, your doctor may order blood tests to see if any adjustment in dose is required.
Slovenian: Kasneje bo zdravnik morda naročil teste krvi, da vidi, ali je treba prilagoditi odmerek.
English: Silapo has no or negligible effect on the ability to drive and use machines.
Slovenian: Zdravilo Silapo nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.
Slovenian: Poročali so o pojavu eritroblastopenije (PRCA), povzročene s protitelesi, po več mesecih ali letih zdravljenja z epoetinom alfa.
English: • Redness, burning and pain at the site of injection
Slovenian: • Rdečina, pekoč občutek in bolečina na mestu injiciranja.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: A minimum of 4 weeks should elapse between dose increases.
Slovenian: Med povečanji odmerka morajo preteči vsaj 4 tedni.
English: 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).
Slovenian: 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.
English: A maximum volume of 1 ml at one injection site should generally not be exceeded.
Slovenian: Na mestu injiciranja se v splošnem ne sme dajati volumen večji kot 1ml.
English: 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).
Slovenian: 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):
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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").
English: Dose (IU/kg given 3 times per week)
Slovenian: Odmerek (i.e./kg 3-krat na teden)
English: • the blister sealing is broken or the blister is damaged in any way
Slovenian: • če je pečat na ovojnini pretrgan ali če je ovojnina na kakršenkoli način poškodovana
English: 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).
Slovenian: 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).
English: When your condition has been brought under control, you will receive regular doses of Silapo, 2 or 3 times a week.
Slovenian: Ko je Vaše stanje pod nadzorom, boste dvakrat ali trikrat na teden dobivali običajne odmerke zdravila Silapo.
English: 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.
Slovenian: 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.
English: Silapo must not be administered by intravenous infusion.
Slovenian: Zdravilo Silapo se ne sme dajati z intravenozno infuzijo.
English: Your doctor will order regular blood tests to ensure that your medicine is continuing to work properly.
Slovenian: Vaš zdravnik bo redno opravljal preiskave krvi, da preveri, če Vaše zdravilo še naprej pravilno učinkuje.
English: Remove the syringe from the blister and check that the solution is clear, colourless and practically free from visible particles.
Slovenian: Vzemite injekcijsko brizgo iz ovojnine in se prepričajte, da je raztopina bistra, brezbarvna in praktično brez vidnih delcev.
English: Use in adult patients in an autologous predonation programme The recommended starting dose is 600 IU/kg.
Slovenian: Odrasli kirurški bolniki v programu darovanja avtologne krvi Priporočeni začetni odmerek je 600 i.e./kg.
English: The recommended starting dose of Silapo is 50 IU/kg (International Units per kilogram).
Slovenian: Priporočeni začetni odmerek je 50 i.e./kg (mednarodnih enot na kilogram).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Zdravilo Silapo se lahko daje pod kožo (subkutano) ali v obliki injekcije v veno ali v cevko, ki vodi v veno.
English: MedDRA System Organ Classification (SOC)
Slovenian: Organski sistem po klasifikaciji MedDRA
English: 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).
Slovenian: 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).
English: At each step, the increase or reduction in dose should be of 25 IU/kg 3 times per week.
Slovenian: Pri vsakem koraku je treba odmerek zvečati ali zmanjšati za 25 i.e/kg trikrat na teden.