FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall survival outcome in the trials could not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group.
Slovenian: Rezultata skupnega preživetja v preskušanjih niso mogli zadovoljivo razložiti z razlikami v pojavnosti tromboze in povezanih zapletov pri tistih, ki so prejemali rekombinantni humani eritropoetin, in tistih v kontrolni skupini.
English: A bone marrow examination should also be considered for diagnosis of PRCA.
Slovenian: Pri diagnosticiranju PRCA je treba razmisliti tudi o preiskavi kostnega mozga.
English: What Retacrit is and what it is used for What you need to know before you use Retacrit How to use Retacrit
Slovenian: Kaj je zdravilo Retacrit in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Retacrit Kako uporabljati zdravilo Retacrit Možni neželeni učinki
English: Your healthcare professional will always record the exact product you are using.
Slovenian: Zdravnik bo vedno zabeležil, katero zdravilo uporabljate.
English: The use of Retacrit in patients scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation programme is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
Slovenian: Uporaba zdravila Retacrit pri bolnikih, ki so naročeni na večji elektivni ortopedski kirurški poseg in ne sodelujejo v programu darovanja avtologne krvi, je kontraindicirana pri bolnikih s hudo koronarno, periferno arterijsko, karotidno ali cerebrovaskularno boleznijo, vključno z bolniki, ki so nedavno preboleli miokardni infarkt ali cerebrovaskularni dogodek.
English: The exposure of paediatric patients with chronic renal failure on haemodialysis in clinical trials and post-marketing experience is limited.
Slovenian: Izpostavljenost pediatričnih bolnikov s kronično ledvično okvaro na hemodializi v kliničnih preskušanjih in iz izkušenj v obdobju trženja je omejena.
English: Retacrit may be given by injection:
Slovenian: Zdravilo Retacrit lahko prejemate z injekcijo:
English: If you use more Retacrit than you should
Slovenian: Če ste uporabili večji odmerek zdravila Retacrit, kot bi smeli
English: Your doctor will monitor your blood pressure regularly while you are using Retacrit.
Slovenian: Zdravnik bo med zdravljenjem z zdravilom Retacrit redno spremljal vaš krvni tlak.
English: “Instructions on how to inject Retacrit yourself” can be found at the end of the package leaflet.
Slovenian: ''Navodila o tem, kako si zdravilo Retacrit injicirate sami'' so na voljo na koncu navodila za uporabo.
English: The most frequent adverse drug reaction during treatment with epoetin alfa is a dose-dependent increase in blood pressure or aggravation of existing hypertension.
Slovenian: Najpogostejši neželeni učinek, ki se pojavi med zdravljenjem z epoetinom alfa, je od odmerka odvisno zvišanje krvnega tlaka ali poslabšanje obstoječe hipertenzije.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno zdravilo in injekcijske igle je treba odstraniti v skladu z lokalnimi predpisi.
English: Cases have also been reported in patients with hepatitis C treated with interferon and ribavirin, when ESAs are used concomitantly.
Slovenian: O primerih PRCA so poročali tudi pri bolnikih s hepatitisom C, ki so se zdravili z interferonom in ribavirinom s sočasno uporabo ESA.
English: INTERMEDIATE CARTON (WITHOUT BLUE BOX) COMPONENT OF MULTIPACK
Slovenian: VMESNA (NOTRANJA) ŠKATLA (BREZ PODATKOV ZA BLUE BOX), DEL SKUPNEGA PAKIRANJA
English: • Do not hold by the plunger head, plunger or needle cover.
Slovenian: • Ne dotikajte se bata, glavice bata ali pokrovčka igle.
English: A randomized prospective trial (CHOIR) evaluated 1,432 anaemic chronic renal failure patients who were not undergoing dialysis.
Slovenian: V randomiziranem, prospektivnem preskušanju (CHOIR) so ocenili 1.432 anemičnih bolnikov s kronično ledvično odpovedjo, ki se niso zdravili z dializo.
English: • Do not attempt to inject yourself unless you have been trained to do so by your doctor or nurse.
Slovenian: • Ne poskušajte si zdravila injicirati sami, dokler vas zdravnik ali medicinska sestra ne naučita, kako to storiti.
English: • When the needle is pulled out of your skin, there may be a little bleeding at the injection site.
Slovenian: • Ko boste iglo potegnili iz kože, se bo na mestu injiciranja morda pojavila majhna krvavitev.
English: In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the haemoglobin concentration range as recommended in section 4.2.
Slovenian: Pri bolnikih s kronično ledvično okvaro vzdrževalna koncentracija hemoglobina ne sme presegati zgornje meje razpona koncentracije hemoglobina, ki je podana v poglavju 4.2.
English: Take special care with other products that stimulate red blood cell production:
Slovenian: Bodite posebej pozorni na zdravila, ki spodbujajo nastajanje rdečih krvnih celic:
English: Erythropoietins exhibit a dose-related effect on haematological parameters which is independent of route of administration.
Slovenian: Eritropoetin kaže od odmerka odvisen učinek na hematološke parametre, ki ni odvisen od poti uporabe.
English: o in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients (see section 4.4).
Slovenian: o pri odraslih z ledvično insuficienco, ki se jih še ne zdravi z dializo za zdravljenje hude anemije ledvičnega izvora s spremljajočimi kliničnimi znaki pri bolnikih (glejte poglavje 4.4).
English: In repeated dose toxicological studies in dogs and rats, but not in monkeys, epoetin alfa therapy was associated with subclinical bone marrow fibrosis.
Slovenian: V toksikoloških študijah pri ponavljajočih odmerkih na psih in podganah, ne pa na opicah, je terapijo z epoetinom alfa spremljala subklinična fibroza kostnega mozga .
English: In those situations in which the physician determines that a patient or caregiver can safely and effectively administer Retacrit subcutaneously themselves, instruction as to the proper dosage and administration should be provided.
Slovenian: Če zdravnik ugotovi, da si zdravilo Retacrit lahko varno in učinkovito daje subkutano bolnik sam ali mu ga daje skrbnik, je treba zagotoviti navodila za pravilno odmerjanje in injiciranje.
English: The first evidence of a response to epoetin alfa is an increase in the reticulocyte count within 10 days, followed by increases in the red cell count, haemoglobin and haematocrit, usually within 2 to 6 weeks.
Slovenian: Prvi dokaz za odziv na epoetin alfa je zvečanje števila retikulocitov v 10 dneh, ki mu sledijo povečanje števila rdečih krvničk, koncentracije hemoglobina in vrednosti hematokrita, običajno v 2 do 6 tednih.
English: Pure Red Cell Aplasia (PRCA)
Slovenian: Čista aplazija rdečih krvnih celic (PRCA - pure red cell aplasia)
English: The absolute bioavailability of subcutaneous injectable erythropoietin is approximately 20% in healthy subjects.
Slovenian: Absolutna biorazpoložljivost eritropoetina, ki se injicira subkutano, je pri zdravih preskušancih približno 20 %.
English: Bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
Slovenian: Fibroza kostnega mozga je pri ljudeh znan zaplet kronične ledvične odpovedi, ki je lahko povezana s sekundarnim hiperparatiroidizmom ali neznanimi dejavniki.
English: This medicinal product contains phenylalanine which may be harmful for people with phenylketonuria.
Slovenian: To zdravilo vsebuje fenilalanin, ki lahko škoduje ljudem s fenilketonurijo.
English: Adults on chemotherapy
Slovenian: Odrasli na kemoterapiji
English: As with any other injectable product, check that there are no particles in the solution or change in colour.
Slovenian: Kot pri vsakem drugem zdravilu za injiciranje se prepričajte, da v raztopini ni vidnih delcev in da ni obarvana.
English: No evidence exists that indicates an interaction between epoetin zeta and G-CSF or GM-CSF with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro.
Slovenian: Ni dokazov za medsebojno delovanje med epoetinom zeta in G-CSF ali GM-CSF glede na in vitro hematološko diferenciacijo ali proliferacijo vzorcev tumorjev, ki so bili pridobljeni z biopsijo.
English: The recommended total weekly dose is between 75 IU/kg and 300 IU/kg.
Slovenian: Priporočeni skupni tedenski odmerek je med 75 i.e./kg in 300 i.e./kg.
English: Talk to your doctor if any of the following apply to you.
Slovenian: Posvetujte se z zdravnikom, če za vas velja karkoli od naslednjega.
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 rdečkaste, tarčam podobne makule ali okrogle zaplate na trupu s pogostimi mehurčki v njihovem središču, luščenje kože, razjede v ustih, žrelu, nosu, na genitalijah in očeh, preden se pojavijo, pa lahko nastopijo zvišana telesna temperatura in gripi podobni simptomi.
English: Despite differences in concentration-time profiles the pharmacodynamic response (as measured by changes in percent reticulocytes, haemoglobin, and total RBCs) was similar between these regimens.
Slovenian: Kljub razlikam v profilih koncentracije v odvisnosti od časa je bil farmakodinamični odziv (merjen s spremembami odstotka retikulocitov, vrednosti hemoglobina in celokupnega števila rdečih krvničk) med tema režimoma podoben.
English: Mean haemoglobin levels were similar for the two treatment groups throughout the postsurgical period.
Slovenian: Povprečne koncentracije hemoglobina so bile podobne v obeh zdravljenih skupinah ves čas obdobja po kirurškem posegu.
English: In these studies, most were predialysis patients (N=44), 27 patients were on peritoneal dialysis and 2 were on haemodialysis with age ranging from 4 months to 17 years.
Slovenian: V teh študijah se večina bolnikov še ni zdravila z dializo (n = 44), 27 bolnikov se je zdravilo s peritonealno dializo, 2 pa sta se zdravila s hemodializo, pri čemer je bila starost od 4 mesecev do 17 let.
English: In cell cultures of human bone marrow cells, epoetin alfa stimulates erythropoiesis specifically and does not affect leucopoiesis.
Slovenian: Epoetin alfa v celičnih kulturah človeškega kostnega mozga specifično stimulira eritropoezo in ne vpliva na levkopoezo.
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: Following subcutaneous injection, serum levels of erythropoietin reach a peak between 12 and 18 hours post-dose.
Slovenian: Po subkutani injekciji koncentracije eritropoetina dosežejo vrh med 12 in 18 urami po odmerjanju.
English: In the 20-week study (n=225), no significant difference was observed in the primary efficacy endpoint, i.e. the proportion of patients who required a RBC transfusion after Day 28 (62% of epoetin alfa patients versus 69% of standard therapy patients).
Slovenian: V 20-tedenski študiji (n = 225) ni bilo pomembne razlike pri primarnem opazovanem dogodku učinkovitosti, tj. deležu bolnikov, ki so potrebovali transfuzijo rdečih krvničk po 28. dnevu (62 % bolnikov, ki so se zdravili z epoetinom alfa, v primerjavi z 69 % bolnikov, ki so se zdravili s standardnim zdravljenjem).
English: Administration of single doses of 300 to 2 400 IU/kg subcutaneous erythropoietin resulted in a linear relationship between mean Cmax and dose and between mean AUC and dose.
Slovenian: Dajanje enkratnih odmerkov 300 do 2.400 i.e./kg eritropoetina subkutano je povzročilo linearno razmerje med povprečno vrednostjo Cmax in odmerkom ter med povprečno vrednostjo AUC in odmerkom.
English: Additionally, cerebrovascular accidents (including cerebral infarction, cerebral haemorrhage and transient ischaemic attacks) have been reported.
Slovenian: Dodatno so poročali tudi o cerebrovaskularnih dogodkih (vključno z možganskim infarktom, možgansko krvavitvijo in prehodnimi možganskimi ishemijami).
English: No paediatric-specific adverse reactions not mentioned previously in the table above, or any that were not consistent with the underlying disease were reported in this population.
Slovenian: O neželenih učinkih, specifičnih za pediatrično populacijo, ki ne bi že bili omenjeni v zgornji preglednici ali ki ne bi bili skladni z osnovno boleznijo, pri tej populaciji niso poročali.
English: Chronic renal failure patients treated with epoetin zeta by the subcutaneous route should be monitored regularly for loss of efficacy, defined as absent or decreased response to epoetin zeta treatment in patients who previously responded to such therapy.
Slovenian: Bolnike s kronično ledvično okvaro, ki epoetin zeta prejemajo subkutano, je treba redno spremljati glede izgube učinkovitosti, ki se kaže kot odsotnost ali zmanjšan odziv na zdravljenje z epoetinom zeta, pri tistih bolnikih, ki so se že odzivali na tako zdravljenje.
English: Based on information available to date, correction of anaemia with epoetin zeta in adult patients with renal insufficiency not yet undergoing dialysis does not accelerate the rate of progression of renal insufficiency.
Slovenian: Na osnovi podatkov, ki so trenutno na razpolago, popravki anemije z epoetinom zeta pri odraslih bolnikih z ledvično nezadostnostjo, ki še niso na dializi, razvoja ledvične nezadostnosti ne pospešujejo.
English: Some patients with more extended dosing intervals (greater than once weekly) of epoetin zeta may not maintain adequate haemoglobin levels (see section 5.1) and may require an increase in epoetin zeta dose.
Slovenian: Nekateri bolniki z daljšimi odmernimi intervali epoetina zeta (daljšimi kot enkrat tedensko) morda ne bodo ohranili ustreznih nivojev hemoglobina (glejte poglavje 5.1) in bodo morda potrebovali višji odmerek epoetina zeta.
English: Hypertensive crisis with encephalopathy and seizures, requiring the immediate attention of a physician and intensive medical care, have occurred also during epoetin zeta treatment in patients with previously normal or low blood pressure.
Slovenian: Hipertenzivna kriza z encefalopatijo in epileptičnimi napadi, ki zahteva takojšnjo zdravniško pomoč in intenzivno zdravstveno oskrbo, se je pri zdravljenju z epoetinom zeta pojavila tudi pri bolnikih, ki so imeli pred tem normalen ali nizek krvni tlak.
English: • Let go of the plunger and allow the syringe to move up until the entire needle is guarded and locks into place.
Slovenian: • Izpustite bat in pustite, da se brizga pomakne navzor, dokler celotna igla ni pokrita in se ne zaskoči.
English: Eighty-one percent of patients achieved the haemoglobin concentration level.
Slovenian: Želeno koncentracijo hemoglobina je doseglo 81 % bolnikov.
English: Raised blood pressure may require treatment with medicines (or adjustment to any medicines you already take for high blood pressure).
Slovenian: Zvišan krvni tlak bo morda treba zdraviti z zdravili (ali prilagoditi odmerke zdravil,
English: You may still be able to use Retacrit, but discuss it with your doctor first.
Slovenian: Zdravilo Retacrit boste morda lahko še vedno jemali, vendar se o tem najprej posvetujte z zdravnikom.
English: 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.
Slovenian: V treh največjih kliničnih preskušanjih, ki so jih izvedli pri odraslih bolnikih na dializi, je bil mediani vzdrževalni odmerek, potreben za vzdrževanje vrednosti hematokrita med 30 in 36 %, približno 75 i.e./kg trikrat na teden.
English: In clinical trials at starting doses of 50 to 150 IU/kg, three times per week, approximately 95% of all patients responded with a clinically significant increase in haematocrit.
Slovenian: V kliničnih preskušanjih z začetnimi odmerki od 50 do 150 i.e./kg trikrat na teden se je približno 95 % bolnikov odzvalo s klinično pomembnim povečanjem vrednosti hematokrita.
English: Retacrit should be administered by the intravenous route.
Slovenian: Zdravilo Retacrit je treba dajati po intravenski poti.
English: • Push the plunger with your thumb as far as it will go to inject the entire amount of liquid.
Slovenian: • S prstom do konca pritisnite na bat, da boste injicirali celotno količino tekočine.
English: The role of ESAs on tumour progression or reduced progression-free survival cannot be excluded.
Slovenian: Vloge ESA na napredovanje tumorja ali skrajšano preživetje brez napredovanja bolezni ni mogoče izključiti.
English: People with kidney disease
Slovenian: Ljudje z boleznimi ledvic
English: • The usual starting dose of Retacrit for adults and children is 50 International Units (IU) per kilogram (/kg) of body weight given three times a week.
Slovenian: • Običajni začetni odmerek zdravila Retacrit za odrasle in otroke je 50 mednarodnih enot (IUInternational Unit) na kilogram (/kg) telesne mase, ki ga dajemo trikrat tedensko.
English: Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive Retacrit 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 Retacrit ali kateregakoli drugega eritropoetina ne smejo dobivati (glejte poglavje 4.4).
English: In the 16-week study (n=222), in the epoetin alfa-treated patients there was no statistically significant effect on patient-reported or parent-reported Paediatric Quality of Life Inventory or Cancer Module scores compared with placebo (primary efficacy endpoint).
Slovenian: V 16-tedenski študiji (n = 222) pri bolnikih, ki so se zdravili z epoetinom alfa, ni bilo statistično pomembnega učinka na rezultate pri pediatričnem vprašalniku o kakovosti življenja ali modulu za raka, o katerih so poročali bolniki ali starši, v primerjavi s placebom (primarni opazovani dogodek učinkovitosti).
English: In addition, thrombocythaemia above the normal range has been reported.
Slovenian: Poleg tega so poročali tudi o trombocitemiji nad normalno vrednostjo.
English: This is characterised by a sustained decrease in haemoglobin despite an increase in epoetin zeta dosage (see section 4.8).
Slovenian: Značilno je tudi trajno zmanjšanje hemoglobina kljub povečanju odmerka epoetina zeta (glejte poglavje 4.8).
English: Retacrit therapy should continue until one month after the end of chemotherapy.
Slovenian: S terapijo z zdravilom Retacrit moramo nadaljevati še en mesec po zaključku kemoterapije.
English: A less defined profile was observed for RBCs and haemoglobin.
Slovenian: Manj definiran profil so opazili pri eritrocitih in hemoglobinu.
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 1 ml.
English: Autologous predonation programme
Slovenian: Avtologni preddonorski program
English: Retacrit and other products that stimulate red cell production may increase the risk of developing blood clots in all patients.
Slovenian: Zdravilo Retacrit in druga zdravila, ki spodbujajo tvorbo rdečih krvnih celic, lahko pri vseh bolnikih povečajo tveganje za nastanek krvnih strdkov.
English: 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 Retacrit.
Slovenian: Če jemljete zdravilo, imenovano ciklosporin (uporablja se npr. po presaditvi ledvic), vam bo zdravnik morda predpisal teste krvi, s katerimi bo med jemanjem zdravila Retacrit preveril koncentracijo ciklosporina.
English: The prefilled syringes contain between 0.3 and 1 ml solution, depending on the content of epoetin zeta (see “What Retacrit contains”).
Slovenian: Napolnjene injekcijske brizge vsebujejo med 0,3 in 1 ml raztopine, odvisno od vsebnosti epoetina zeta (glejte "Kaj vsebuje zdravilo Retacrit").
English: • if 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: If signs and symptoms suggestive of these reactions appear, Retacrit 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 Retacrit takoj prekiniti in razmisliti o drugi vrsti zdravljenja.
English: Retacrit is one of a group of products that stimulate the production of red blood cells, like the human protein erythropoietin does.
Slovenian: Retacrit je eno izmed zdravil, ki spodbuja nastajanje rdečih krvnih celic, kakor jo spodbuja človeška beljakovina eritropoetin.
English: • Retacrit is given by injection under the skin each week for three weeks before surgery and on the day of surgery.
Slovenian: • Zdravilo Retacrit se daje z injekcijo pod kožo vsak teden, z začetkom tri tedne pred kirurškim posegom in na dan kirurškega posega.
English: 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.
Slovenian: Pri ambulantni uporabi lahko zdravilo vzamete iz hladilnika, ne da bi ga zamenjali, in ga nato hranite največ 3 dni pri sobni temperaturi, ki ne presega 25 ºC.
English: The studies either recruited patients who were being treated with chemotherapy (two studies) or used patient populations in which ESAs are not indicated: anaemia in patients with cancer not receiving chemotherapy, and head and neck cancer patients receiving radiotherapy.
Slovenian: V študije so vključili bolnike, ki so bili deležni kemoterapije (dve študiji) ali pa so uporabljali populacije bolnikov, pri katerih zdravila za stimulacijo eritropoeze niso bila indicirana: anemija pri bolnikih z rakom, ki ne prejemajo kemoterapije ter bolniki z rakom glave in vratu, ki prejemajo terapijo z obsevanjem.
English: 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.
Slovenian: Študije na živalih so pokazale, da epoetin alfa zmanjšuje telesno maso ploda, zakasni osifikacijo in povečuje smrtnost pri plodih, če se ga daje v tedenskih odmerkih, ki so približno dvajsetkratna vrednost priporočenega tedenskega odmerka za ljudi.
English: • Retacrit is given by injection under the skin.
Slovenian: • Zdravilo Retacrit dajemo z injiciranjem pod kožo.