FrancophonIA/ELRC3.0 huggingface dataset:
English: Monitoring of reticulocyte count on a regular basis is recommended to detect possible occurrence of lack of efficacy in chronic renal failure patients.
Slovenian: Priporoča se reden nadzor števila retikulocitov, ker se s tem pri bolnikih s kronično ledvično okvaro lahko ugotovi možna odsotnost učinkovitosti zdravljenja.
English: If you forget to use Silapo
Slovenian: Če ste pozabili uporabiti zdravilo Silapo
English: 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.
Slovenian: 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.
English: Silapo has a wide safety margin and side effects due to an overdose of using Silapo are unlikely.
Slovenian: Zdravilo Silapo ima veliko varnostno rezervo, tako da neželeni učinki zaradi prevelikega odmerka niso verjetni.
English: Special warnings
Slovenian: Posebna opozorila
English: The recommended starting dose of Silapo is 450 IU/kg (maximum total dose is 40 000 IU).
Slovenian: Priporočeni začetni odmerek zdravila Silapo je 450 i.e./kg (največji skupni odmerek je 40 000 i.e.).
English: 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.
Slovenian: Zdravniku ali medicinski sestri nemudoma povejte, če opazite kateregakoli od teh neželenih učinkov ali če med zdravljenjem z zdravilom Silapo opazite druge neželene učinke.
English: in anaemic adult patients with myelodysplastic syndrome to reduce the need for a blood transfusion.
Slovenian: za slabokrvne odrasle bolnike z mielodisplastičnim sindromom, da bi zmanjšali potrebo po transfuziji krvi.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Use in adult patients with kidney disease but not receiving dialysis The recommended starting dose is 50 IU/kg.
Slovenian: Uporaba pri odraslih bolnikih z boleznijo ledvic, ki niso na dializi Priporočeni začetni odmerek je 50 i.e./kg.
English: 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).
Slovenian: 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).
English: Adult patients with low- or intermediate-1-risk MDS
Slovenian: Odrasli bolniki z MDS z nizkim ali srednjim-1 tveganjem
English: At the start of your therapy, Silapo is injected by medical or nursing staff.
Slovenian: Ob začetku Vaše terapije vam bodo zdravilo Silapo injicirali medicinske sestre ali zdravnik.
English: 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.
Slovenian: 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.
English: Median
Slovenian: Mediana
English: 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.
Slovenian: Pri bolnikih z rakom, ki prejemajo rekombinantni humani eritropoetin, obstaja povečano tveganje za tromboembolijske dogodke, negativnega vpliva na skupno preživetje pa ni mogoče izključiti.
English: 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%.
Slovenian: 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.
English: 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.
Slovenian: Fenilalanin lahko škoduje bolnikom s fenilketonurijo, redko genetsko boleznijo pri kateri pride do kopičenja fenilalanina, ker se ne more ustrezno odstranjevati iz telesa.
English: 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).
Slovenian: 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).
English: Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e.g. stenoses, aneurysms, etc.).
Slovenian: 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).
English: If Silapo is injected under the skin the amount injected in any one place should not exceed 1 ml.
Slovenian: Če si zdravilo Silapo injicirate pod kožo, se na enem mestu ne sme injicirati več kot 1 ml.
English: • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/dl (8.7 mmol/l),
Slovenian: • skrajšanega časa do napredovanja tumorja pri bolnikih z napredovalim rakom glave in vratu, ki prejemajo terapijo z obsevanjem pri dajanju zdravil z namenom doseči ciljne koncentracije hemoglobina, ki so večje od 14 g/dl (8,7 mmol/l),
English: In two large, open-label studies, 2 697 cancer patients receiving non-platinum chemotherapy were included, 1 895 with solid tumours (683 breast, 260 lung, 174 gynaecological, 300 gastrointestinal, and 478 other tumour types) and 802 with haematological malignancies.
Slovenian: V dve veliki odprti študiji je bilo vključeno 2 697 bolnikov z rakom na kemoterapiji brez platine, 1 895 s čvrstimi tumorji (683 dojke, 260 pljuč, 174 ginekološki, 300 gastrointestinalni, in 478 s tumorji drugih vrst) in 802 s hematološkimi malignimi obolenji.
English: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na enota odmerka, kar v bistvu pomeni ´brez natrija´.
English: Phenylalanine may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Slovenian: Fenilalanin vam lahko škoduje, če imate fenilketonurijo, redko genetsko bolezen pri kateri pride do kopičenja fenilalanina, ker se ne more ustrezno odstranjevati iz telesa.
English: in adult patients with renal insufficiency not yet on dialysis to treat severe anaemia associated with kidney disease accompanied by clinical symptoms.
Slovenian: pri odraslih bolnikih z ledvično okvaro, ki še niso na dializi, za zdravljenje hude anemije v zvezi z boleznijo ledvic, ki jo spremljajo klinični simptomi.
English: 300 IU/kg 3x/week for 4 weeks
Slovenian: 300 i.e./kg 3-krat na teden 4 tedne
English: • Nose or airway congestion
Slovenian: • Kongestija nosu ali dihal.
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13 933 patients) and for the cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10 441 patients).
Slovenian: Metaanaliza podatkov o celotnem preživetju bolnikov daje oceno stopnje tveganja 1,06 v prid kontrolni skupini (95 % CI; 1,00; 1,12; 53 preskušanj in 13 933 bolnikov), za bolnike z rakom, ki so dobivali kemoterapijo, je bila stopnja tveganja za celotno preživetje 1,04 (95 % CI: 0,97; 1,11; 38 preskušanj in 10 441 bolnikov).
English: Key baseline characteristics for the <200 mU/ml stratum are shown in the table below.
Slovenian: Ključne izhodiščne značilnosti skupine z < 200 mU/ml so prikazane v spodnji preglednici.
English: Particular attention should be paid to sudden stabbing migraine like headaches as a possible warning signal.
Slovenian: Še posebej je treba biti pozoren, če se pojavijo nenadni, migreni podobni glavoboli z zbadanjem, ki so lahko morebiten opozorilni znak.
English: Consequently, haemoglobin and blood pressure should be closely monitored.
Slovenian: Zato je treba krvni tlak in koncentracijo hemoglobina natančno spremljati.
English: Cytotoxic actions of erythropoietin on bone marrow cells could not be detected.
Slovenian: Citotoksičnega delovanja eritropoetina na celice v kostnem mozgu ni bilo zaznati.
English: Pure Red Cell Aplasia (PRCA) has been reported very rarely after months to years of subcutaneous treatment with other products containing erythropoietins and may not be ruled out with Silapo.
Slovenian: O čisti aplaziji rdečih krvnih celic (PRCA) so poročali v redkih primerih po več mesecih ali letih zdravljenja z drugimi zdravili z eritropoetinom, zato te možnosti pri zdravilu Silapo ni mogoče izključiti.
English: What Silapo looks like and contents of the pack
Slovenian: Izgled zdravila Silapo in vsebina pakiranja
English: A patient-level data analysis has also been performed on more than 13 900 cancer patients (chemo-, radio-, chemoradio-, or no therapy) participating in 53 controlled clinical trials involving several epoetins.
Slovenian: Pri več kot 13 900 bolnikih z rakom (kemoterapija, radioterapija, kemo-radioterapija ali nezdravljeni), ki so sodelovali v 53 kontroliranih kliničnih preskušanjih v katerih so uporabili različne epoetine, je bila narejena analiza podatkov o bolnikih.
English: Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients
Slovenian: Zdravljenje simptomatske anemije pri odraslih in pediatričnih bolnikih s kronično ledvično okvaro
English: PRCA means the bone marrow does not make enough red blood cells.
Slovenian: PRCA pomeni nezmožnost kostnega mozga, da proizvede dovolj rdečih krvnih celic.
English: The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 3 days (but not above 25°C).
Slovenian: Injekcijsko brizgo lahko vzamete iz hladilnika in jo nato hranite pri sobni temperaturi (do 25 ºC), vendar največ 3 dni.
English: The solution contains 3 333 IU Epoetin zeta per ml.
Slovenian: Raztopina vsebuje 3 333 i.e. epoetina zeta na ml.
English: How to use Silapo
Slovenian: Kako uporabljati zdravilo Silapo
English: 25 and 50 IU/kg 2 times per week into 2 equal doses.
Slovenian: Vzdrževalni odmerek med 25 in 50 i.e./kg dvakrat tedensko v dveh enakih odmerkih.
English: • Bone or muscle pain
Slovenian: • Bolečine v kosteh ali mišicah.
English: Silapo is given by injection under the skin.
Slovenian: Zdravilo Silapo dajemo z injiciranjem pod kožo.
English: Erythropoietin is a growth factor that primarily stimulates red cell production.
Slovenian: Eritropoetin je rastni dejavnik, ki primarno stimulira nastajanje rdečih krvničk.
English: *Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
Slovenian: * pridobljeno iz celične linije jajčnika kitajskega hrčka (CHO - "Chinese Hamster Ovary") s tehnologijo rekombinantne DNA
English: Patients should be monitored closely to ensure that the lowest approved effective dose of Silapo is used to provide adequate control of the symptoms of anaemiawhilst maintaininga haemoglobin concentrationbelowor at 12g/dl(7.5mmol/l).
Slovenian: Bolnike morate skrbno nadzorovati, da bi zagotovili uporabo najnižjega odobrenega učinkovitega odmerka zdravila Silapo za primeren nadzor simptomov anemije, pri čemer naj koncentracija hemoglobina ostane pod ali pri 12g/dl (7,5 mmol/l).
English: If it occurs, appropriate dose adjustment should be made as provided.
Slovenian: Če do tega vseeno pride, morate odmerek primerno prilagoditi skladno z navodili.
English: Silapo contains phenylalanine
Slovenian: Zdravilo Silapo vsebuje fenilalanin
English: For patients scheduled for major elective orthopaedic surgery, iron supplementation (elemental iron 200 mg/day orally) should be administered throughout the course of epoetin zeta therapy.
Slovenian: Za bolnike, naročene na večji elektivni ortopedski kirurški poseg, je treba nadomestke železa (elementarno železo 200 mg/dan peroralno) dajati ves cikel zdravljenja z epoetinom zeta.
English: Very common: may affect more than 1 in 10 people
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov:
English: • Blood clot in an artificial kidney.
Slovenian: • Krvni strdek v umetni ledvici.
English: All of the responding subjects were in the stratum with sEPO <200 mU/ml during screening.
Slovenian: Vsi odzivni preskušanci so bili med presejanjem v skupini s sEPO < 200 mU/ml.
English: Cancer patients on erythropoietin should have haemoglobin (the part of a red blood cell that carries oxygen) levels measured on a regular basis until a stable level is achieved, and periodically thereafter.
Slovenian: Bolnikom z rakom, ki dobivajo eritropoetin, je treba redno meriti nivo hemoglobina (delež rdečih krvnih celic, ki prenašajo kisik) tako dolgo, da se koncentracija ustali, potem pa v enakih časovnih intervalih.
English: If you experience headaches, particularly sudden, stabbing migraine-like headaches or feel confused or have fits, tell your doctor immediately.
Slovenian: Če se pojavijo glavoboli, še posebej nenadni, migreni podobni glavoboli z zbadanjem, ste zmedeni ali imate napade, o tem takoj obvestite svojega zdravnika.
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section
Slovenian: Metaanaliza dosledno kaže tudi na statistično pomembno zvečanje relativnega tveganja za pojav tromboemboličnih dogodkov pri bolnikih z rakom, ki prejemajo rekombinantni humani eritropoetin.
English: The recommended dose is 600 IU/kg administered subcutaneously weekly for three weeks (days -21,14 and -7) prior to surgery and on the day of surgery.
Slovenian: Priporočeni odmerek 600 i.e./kg telesne mase je treba dajati subkutano enkrat na teden, tri tedne (na 21., 14. in 7. dan) pred kirurškim posegom in na dan kirurškega posega (dan 0).
English: Silapo should also be used with caution in the presence of epilepsy and chronic liver failure.
Slovenian: Zdravilo Silapo je treba previdno uporabljati pri epilepsiji in kronični ledvični odpovedi.
English: At a rate of rise in haemoglobin of > 2 g/dl (> 1.25 mmol/l) per month the Silapo dose should be reduced by about 25-50%.
Slovenian: Če je zvišanje hemoglobina >2 g/dl (>1,25 mmol/l) na mesec, je treba odmerek zdravila Silapo znižati za okoli 25-50 %.
English: From pretreatment to presurgery, the mean increase in haemoglobin in the 600 IU/kg weekly group (1.44 g/dl) was twice than that observed in the 300 IU/kg daily group (0.73 g/dl).
Slovenian: Od začetka predhodnega zdravljenja do časa prek kururškim posegom je bilo povprečno povečanje hemoglobina v skupini s 600 i.e./kg na teden (1,44 g/dl) dvakrat večje od opaženega v skupini s 300 i.e./kg na dan (0,73 g/dl).
English: The pre-filled syringe is ready for use.
Slovenian: Napolnjena injekcijska brizga z zdravilom Silapo je pripravljena za uporabo.
English: Silapo is used in adults, children and adolescents on haemodialysis to treat symptomatic anaemia (low red blood cell counts) associated with chronic renal failure (kidney disease).
Slovenian: Zdravilo Silapo se uporablja pri odraslih, otrocih in mladostnikih, ki so na hemodializi, kot zdravilo za simptomatsko anemijo (nizko število rdečih krvnih celic) v zvezi s kronično ledvično okvaro (bolezen ledvic).
English: Attention should be paid to sudden stabbing migraine-like headaches as a possible warning signal.
Slovenian: Treba je biti pozoren na nenaden pojav migreni podobnih glavobolov z zbadanjem, ki so lahko morebitni opozorilni znak.
English: The starting dose is 450 IU per kilogram bodyweight once a week.
Slovenian: Začetni odmerek je 450 i.e. na kilogram telesne mase enkrat tedensko.
English: If you develop a serious rash or another of these skin symptoms, stop taking Silapo and contact your doctor or seek medical attention immediately.
Slovenian: Če se je pri vas pojavil hud izpuščaj ali eden od teh kožnih simptomov, prenehajte z jemanjem zdravila Silapo in se takoj posvetujte z zdravnikom ali poiščite zdravniško pomoč.
English: If you experience headaches, particularly sudden, stabbing migraine-like headaches or start to feel confused or have fits, tell your doctor or nursing staff immediately.
Slovenian: Če občutite glavobole, posebno nenadne, zbadajoče napade migrene ali če postanete zmedeni ali imate napade, takoj obvestite svojega zdravnika ali zdravstveno osebje.
English: You will also take iron supplements before and during Silapo treatment to increase the effectiveness of Silapo.
Slovenian: Poleg tega boste tudi jemali dodatke z železom pred in po zdravljenju z zdravilom Silapo, da se poveča njegov učinek.
English: There is no evidence to indicate that treatment with erythropoietin alters the metabolism of other medicinal products.
Slovenian: Dosedanji klinični izsledki ne kažejo, da bi zdravljenje z eritropoetinom spreminjalo presnovo drugih zdravil.
English: Injecting Silapo under the skin yourself
Slovenian: Kako si sami injicirate zdravilo Silapo pod kožo
English: Haemoglobin concentration
Slovenian: Koncentracija hemoglobina
English: The initial dose is 150 IU/kg given subcutaneously 3 times per week.
Slovenian: Začetni odmerek 150 i.e./kg dajemo subkutano trikrat tedensko.
English: • Any liquid has leaked out of the pre-filled syringe or condensation is visible within the sealed blister.
Slovenian: • če je iz vnaprej napolnjene brizge iztekla tekočina ali če je v zavarjenem blistru videti kondenzacijo.
English: In case of larger volumes, more than one site should be chosen for the injection.
Slovenian: Pri večjih volumnih izberemo za injiciranje več mest.
English: The haemoglobin concentration aimed for is between 10 and 12 g/dl (6.2-7.5 mmol/l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/dl (5.9-6.8 mmol/l).
Slovenian: Zdravilo Silapo se lahko daje subkutano ali intravensko Ciljna koncentracija hemoglobina je med 10 in 12 g/dl (6,2-7,5 mmol/l), razen pri pediatričnih bolnikih, kjer mora biti koncentracija hemoglobina med 9,5 in 11 g/dl (5,9-6,8 mmol/l).
English: Non response to erythropoietin therapy should prompt a search for causative factors.
Slovenian: Ob neodzivanju na zdravljenje z eritropoetinom je treba iskati faktorje, ki to povzročajo.
English: What Silapo is and what it is used for What you need to know before you use Silapo How to use Silapo
Slovenian: Kaj je zdravilo Silapo in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Silapo Kako uporabljati zdravilo Silapo Možni neželeni učinki
English: Haemoglobin levels should be measured on a regular basis until a stable level is achieved and periodically thereafter.
Slovenian: Nivo hemoglobina je treba redno meriti toliko časa, dokler se nivo ne ustali, potem pa periodično.
English: An increase in the dose of a particular blood-thinning medicine (heparin) during haemodialysis is often needed during the course of therapy with Silapo to minimise the risk of blood clotting.
Slovenian: Zvišanje odmerka zdravila za redčenje krvi (heparina) med hemodializo je pri zdravljenju z zdravilom Silapo dostikrat potrebno, ker se z njim zmanjšuje možnost strdkov v krvi.
English: Silapo must not be used if
Slovenian: Zdravila Silapo se ne sme uporabljati,
English: ≤2 RBC Units ˃2 and ≤4 RBC Units ˃4 RBC Units No one subject did not have sEPO data in the ≥200 mU/ml stratum there were 13 subjects in the epoetin alfa group and 6 subjects in the placebo group
Slovenian: Da ≤ 2 enoti koncentriranih eritrocitov ˃ 2 in ≤ 4 enote koncentriranih eritrocitov ˃ 4 enote koncentriranih eritrocitov Ne a za enega preskušanca ni bilo podatkov o sEPO v skupini z ≥ 200 mU/ml je bilo 13 preskušancev iz skupine, ki je prejemala epoetin alfa, in 6 iz skupine, ki je prejemala placebo
English: After removing one syringe from the blister pack the solution should be checked to ensure that it is clear, colourless and practically free from visible particles.
Slovenian: Ko injekcijsko brizgo vzamete iz pretisnega omota, preverite, da je raztopina bistra, brezbarvna in praktično brez vidnih delcev.
English: Information on administration
Slovenian: Informacija o uporabi