FrancophonIA/ELRC3.0 huggingface dataset:
English: Analogous results have been found in animal experiments in uraemic and normal rats.
Slovenian: Podobne izide so dobili tudi pri poskusih na normalnih in uremičnih podganah.
English: Instructions for Use intended for healthcare professional only
Slovenian: Navodila za dajanje zdravila, namenjena samo zdravstvenemu osebju
English: Every one or two weeks, the doctor may adjust your dose to find your individual maintenance dose.
Slovenian: Na vsak teden ali dva bo zdravnik morda prilagodil vaš odmerek, da bo določil vaš individualni vzdrževalni odmerek.
English: a) Correcting the anaemia
Slovenian: a) Popravljanje anemije
English: b) Maintaining sufficient red blood cell levels The maintenance dose: Once your red blood cells reach an acceptable level, the dose is reduced to half of the dose used to correct the anaemia.
Slovenian: b) Vzdrževanje zadostnega števila rdečih krvnih celic Vzdrževalni odmerek: ko bo vaša koncentracija rdečih krvnih celic zadostna, bo odmerek zmanjšan na polovico odmerka, ki je bil potreben za popravljanje anemije.
English: · In case of skin contact with medicine, wash the area that touched the medicine with water.
Slovenian: • V primeru stika zdravila s kožo območje dotika z zdravilom sperite z vodo.
English: Its use in this indication must be balanced against the reported increased risk of thromboembolic events.
Slovenian: Uporabo pri tej indikaciji moramo ovrednotiti glede na povečano tveganje trombemboličnih zapletov.
English: If it occurs, appropriate dose adjustment should be made as provided.
Slovenian: Če do tega pride, je treba ustrezno prilagoditi odmerek glede na smernice.
English: Use the syringe within 5 minutes of removing the cap; otherwise, the needle may clog.
Slovenian: Injekcijsko brizgo uporabite v 5 minutah po odstranitvi pokrovčka; v nasprotnem primeru se lahko igla zamaši.
English: Effect on tumour growth
Slovenian: Vplivi na rast tumorjev
English: Particular attention should be paid to sudden stabbing migraine like headaches as a possible warning sign.
Slovenian: Posebno pozorni moramo biti na pojav nenadnih zbadajočih glavobolov, podobnih migrenskim, ki so lahko opozorilni znak.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with epoetin beta should be made taking into account the benefit of breast-feeding to the child and the benefit of epoetin beta therapy to the woman.
Slovenian: Odločiti se je treba med nadaljevanjem/prenehanjem dojenja in nadaljevanjem/prekinitvijo zdravljenja z epoetinom beta, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja z epoetinom beta za mater.
English: Driving and using machines No effects on ability to drive or use machines have been observed.
Slovenian: Vožnja in upravljanje strojev Vplivov na sposobnost vožnje ali upravljanja s stroji niso opazili.
English: - Intravenous administration:
Slovenian: - Intravensko dajanje:
English: Date of the last renewal: 16 July 2007
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 16. julij 2007
English: · Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.
Slovenian: • Ne injicirajte v materina znamenja, brazgotine ali mesta, kjer je koža nežna, rdeča, trda ali poškodovana.
English: NeoRecormon has no influence on the ability to drive and use machines.
Slovenian: Zdravilo NeoRecormon nima vpliva na sposobnost vožnje in upravljanja s stroji.
English: · Choose a different injection site for each new injection.
Slovenian: • Za vsako novo injiciranje izberite drugo mesto injiciranja.
English: Put the protective cap on the top of the device.
Slovenian: Na vrh pripomočka namestite zaščitno zaporko.
English: In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
Slovenian: Pri bolnikih s kronično ledvično boleznijo vzdrževana koncentracija hemoglobina ne sme preseči zgornje meje ciljne koncentracije hemoglobina, priporočene v poglavju 4.2.
English: Bioavailability of epoetin beta after subcutaneous administration is between 23 and 42 % as compared with intravenous administration.
Slovenian: Biološka uporabnost epoetina beta znaša po subkutanem vnosu med 23 in 42 % v primerjavi z intravensko uporabo.
English: · Always keep the syringe dry.
Slovenian: • Injekcijska brizga mora vedno ostati suha.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of the first authorisation: 16 July 1997
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 16. julij 1997
English: Storage Instructions
Slovenian: Navodila za shranjevanje
English: (2) Remove the plastic cap from the vial.
Slovenian: (2) Z viale odstranite plastično zaporko.
English: Your injections are given under the skin or into a vein.
Slovenian: Vaše injekcije se dajejo pod kožo ali v veno.
English: If you get unusual wheezing or difficulty breathing; swollen tongue, face or throat, or swelling around the injection site; if you feel lightheaded or faint or if you collapse, call your doctor at once.
Slovenian: Če se pri vas pojavijo nenavadno sopenje ali težave z dihanjem, otečen jezik, obraz ali vrat ali oteklina na mestu injiciranja, če se počutite omotično ali slabotno ali če se zgrudite, takoj pokličite svojega zdravnika.
English: Injections are given under the skin.
Slovenian: Injekcije dajemo pod kožo.
English: 7 Place the syringe on a clean, flat surface until ready for use.
Slovenian: 7 Injekcijsko brizgo namestite na čisto, ravno površino, dokler ni pripravljena za uporabo.
English: People who are not on haemodialysis will usually have injections under the skin.
Slovenian: Bolniki, ki niso na dializi, bodo običajno prejeli injekcije pod kožo.
English: The therapy should be continued up to 4 weeks after the end of chemotherapy.
Slovenian: Zdravljenje nadaljujemo do 4 tedne po končani kemoterapiji.
English: Further injections are given by your doctor or, after you have been trained, you can inject NeoRecormon yourself (see instructions at the end of this leaflet.)
Slovenian: Nadaljnje injekcije vam bo injiciral zdravnik, po usposabljanju pa si boste lahko zdravilo NeoRecormon injicirali sami (glejte navodila za dajanje zdravila na koncu tega navodila za uporabo).
English: If you are a cancer patient you should be aware that NeoRecormon may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
Slovenian: Če ste bolnik z rakom, morate vedeti, da lahko zdravilo NeoRecormon deluje kot rastni dejavnik za krvne celice in lahko v nekaterih okoliščinah negativno vpliva na razvoj bolezni.
English: Take special care with other products that stimulate red blood cell production:
Slovenian: Bodite posebno pozorni pri uporabi drugih zdravil, ki spodbujajo nastajanje rdečih krvnih celic:
English: 2 Check the carton has not been damaged and check the expiration date on the carton has not passed.
Slovenian: 2 Prepričajte se, da škatla ni poškodovana, in preverite, da je rok uporabnosti na škatli še ustrezen.
English: Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
Slovenian: Zdravnik bo uporabil najmanjši učinkovit odmerek za nadzor simptomov anemije.
English: NeoRecormon injections can then be given by a trained nurse, doctor or other professional.
Slovenian: Injekcije zdravila NeoRecormon vam lahko daje medicinska sestra, zdravnik ali drugo zdravstveno osebje.
English: · Injection needle(s) (27G or 30G (depending on the prescribed strengths of the medicine) with safety shield (used for priming, setting the dose and injecting the medicine).
Slovenian: • Injekcijska igla ali injekcijske igle 27G ali 30G (odvisno od predpisane jakosti zdravila) z varnostno zaščito (uporablja(jo) se za polnjenje, nastavitev odmerka in injiciranje zdravila).
English: Subsequently, the dose is adjusted at intervals of one or two weeks individually for the patient (maintenance dose).
Slovenian: Nato ga individualno prilagajamo bolniku vsak teden ali na dva tedna (vzdrževalni odmerek).
English: Leaving the reconstituted solution outside the refrigerator should be limited to the time necessary for preparing the injections.
Slovenian: Pripravljeno raztopino puščajte zunaj hladilnika le za čas, ki je potreben za pripravo injekcije.
English: In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Slovenian: V štirih, s placebom primerjanih študijah je bil razpon razmerja ogroženosti za celokupno preživetje med 1,25 in 2,47 v korist kontrolne skupine.
English: · An increase in the occurrence of blood clots has been observed.
Slovenian: • Opazili so porast v pojavu krvnih strdkov.
English: The biological efficacy of epoetin beta has been demonstrated after intravenous and subcutaneous administration in various animal models in vivo (normal and uraemic rats, polycythaemic mice, dogs).
Slovenian: Biološka učinkovitost epoetina beta je bila ugotovljena in vivo po intravenskem in subkutanem dajanju v različnih živalskih modelih (normalne in uremične podgane, policitemične miši, psi).
English: Based on results from clinical trials including 1725 patients approximately 8 % of patients treated with NeoRecormon are expected to experience adverse reactions.
Slovenian: Na podlagi izsledkov kliničnih preskušanj, ki so vključevale 1725 bolnikov, se neželeni učinki pojavijo pri približno 8 % bolnikov, ki se zdravijo z zdravilom NeoRecormon.
English: · Do not use if the syringe has been frozen.
Slovenian: • Ne uporabljajte injekcijske brizge, če je bila zamrznjena.
English: PRCA means that the body stopped or reduced the production of red blood cells.
Slovenian: PRCA pomeni, da je v vašem telesu prišlo do prekinitve ali zmanjšanega nastajanja rdečih krvničk.
English: Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life-expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1)
Slovenian: Dejavniki, ki jih je pri oceni treba upoštevati, vključujejo tip in stadij tumorja, stopnjo anemije, pričakovano življenjsko dobo, okolje, v katerem se bolnik zdravi, in bolnikove prioritete (glejte poglavje 5.1).
English: In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer.
Slovenian: V večih kontroliranih študijah niso dokazali, da bi epoetini izboljšali celokupno preživetje ali zmanjšali tveganje za napredovanje rasti tumorja pri bolnikih z anemijo, povezano z rakom.
English: Special Warning: During treatment with NeoRecormon
Slovenian: Posebno opozorilo: Med zdravljenjem z zdravilom NeoRecormon
English: Important: Always keep the sharps disposal container out of reach of children.
Slovenian: Pomembno: Vedno poskrbite, da je vsebnik za odpadne ostre predmete shranjen nedosegljivo otrokom.
English: · Call a doctor at once if you get headaches, especially sudden, stabbing, migraine-like headaches, confusion, speech disturbance, unsteady walking, fits or convulsions.
Slovenian: • Takoj pokličite zdravnika, če se pojavi glavobol, še posebno nenaden, zbadajoč glavobol, podoben migrenskemu, stanje zmedenosti, motnje govora, nestabilna hoja, krči ali konvulzija.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name of the administered ESA should be clearly recorded (or stated) in the patient file.
Slovenian: Za izboljšanje sledljivosti zdravil za stimulacijo eritropoeze (ESA) je treba zaščiteno ime ESA v bolnikovi kartoteki jasno izpisati (oz. navesti).
English: Investigations in cell cultures of human bone marrow cells showed that epoetin beta stimulates erythropoiesis specifically and does not affect leucopoiesis.
Slovenian: Raziskave na celičnih kulturah človeškega kostnega mozga so pokazale, da epoetin beta specifično stimulira eritropoezo, ne pa tudi levkopoeze.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6 (vsebnost priložene ampule z vehiklom).
English: Chemical and physical in-use stability of the reconstituted solution has been demonstrated for one month at 2°C - 8°C.
Slovenian: Kemijska in fizikalna stabilnost pripravljene raztopine je bila dokazana za en mesec pri 2-8 °C.
English: Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50 % in order to maintain haemoglobin at that level.
Slovenian: Ko je pri posameznem bolniku dosežen terapevtski cilj, zmanjšamo odmerek za 25 do 50 %, zato da vzdržujemo koncentracijo hemoglobina.
English: (9) Swirl the vial gently until the lyophilisate has dissolved.
Slovenian: (9) Vialo nežno vrtite, dokler se liofilizat ne raztopi.
English: Endogenous red cell reserve [ml]
Slovenian: Endogena eritrocitna rezerva (ml)
English: It is unknown whether epoetin beta is excreted in human milk.
Slovenian: Ni znano, ali se epoetin beta izloča v materino mleko.
English: · Preventing anaemia in premature infants (weighing 750 to 1500 g and born at less than 34 weeks).
Slovenian: • preprečevanje anemije pri nedonošenčkih (ki tehtajo 750 do 1500 g in so rojeni pri manj kot 34 tednih);
English: · Check the liquid in the syringe.
Slovenian: • Preverite tekočino v injekcijski brizgi.
English: Animal experiments revealed that epoetin beta does not increase the myelotoxicity of cytostatic medicinal products like etoposide, cisplatin, cyclophosphamide, and fluorouracil.
Slovenian: Raziskave na živalih so pokazale, da epoetin beta ne poveča mielotoksičnosti citostatikov, ki zavirajo mitozo, kot so etoposid, cisplatin, ciklofosfamid in fluorouracil.
English: After initiation of therapy, your doctor will maintain your haemoglobin level between 10 and 12 g/dL.
Slovenian: Po začetku zdravljenja bo zdravnik vzdrževal vašo koncentracijo hemoglobina med 10 in 12 g/dl.
English: · Set aside the syringe for 30 minutes so it can warm up on its own to room temperature.
Slovenian: • Injekcijsko brizgo pustite 30 minut, da se ogreje na sobno temperaturo.
English: After subcutaneous administration of epoetin beta to uraemic patients, the protracted absorption results in a serum concentration plateau, whereby the maximum concentration is reached after an average of 12 - 28 hours.
Slovenian: Po subkutanem vnosu epoetina beta uremičnim bolnikom ima podaljšana absorpcija za posledico serumski koncentracijski plato, maksimalna plazemska koncentracija pa je v povprečju dosežena po 12−28 urah.
English: It contains a hormone called epoetin beta, which stimulates the production of red blood cells.
Slovenian: Vsebuje hormon, imenovan epoetin beta, ki spodbuja nastajanje rdečih krvničk.
English: Preparing for injection
Slovenian: Priprava na injiciranje
English: (4) Take the reconstitution and withdrawal device (which allows sterile air exchange) out of the blister and remove the protective cover from the spike.
Slovenian: (4) Iz pretisnega omota vzemite pripomoček za rekonstitucijo in odvzem (ki omogoča sterilno izmenjavo zraka) ter odstranite zaščito s konice.
English: The target haemoglobin concentration in two studies was >13 g/dl; in the remaining three studies it was 12 -14 g/dl.
Slovenian: Ciljne koncentracije hemoglobina so bile v dveh študijah > 13 g/dl, v preostalih treh pa 12−14 g/dl.
English: Your doctor will regularly check your blood pressure, particularly at the beginning of therapy.
Slovenian: Vaš zdravnik bo redno spremljal vaš krvni tlak, še posebej na začetku zdravljenja.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila o rekonstituciji pred aplikacijo zdravila glejte poglavje 6.6.
English: (10) Before and after reconstitution NeoRecormon Multidose must be stored at +2° to +8°C (refrigerator).
Slovenian: (10) Pred in po rekonstituciji je treba zdravilo NeoRecormon večodmerno raztopino za injiciranje shranjevati pri temperaturi med 2 ºC in 8 ºC (v hladilniku).
English: (8) Penetrate the seal with the needle to a depth of about 1 cm and slowly inject the solvent into the vial.
Slovenian: (8) Z iglo predrite pokrov v globino do 1 cm in počasi vbrizgajte vehikel v vialo.
English: These reactions were mild or moderate in nature and subsided after a couple of hours or days.
Slovenian: Ti simptomi so bili blage ali zmerne narave in so izginili po nekaj urah ali dneh.
English: Data from a controlled clinical trial with epoetin alfa or darbepoetin alfa, reported an incidence of stroke as common.
Slovenian: Podatki iz kontroliranega kliničnega preskušanja z epoetinom alfa ali darbepoetinom kažejo, da je incidenca možganske kapi pogosta.
English: Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/dl [6.21 - 8.07 mmol/l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Slovenian: Tovrstno zdravljenje smemo predpisati samo bolnikom z zmerno anemijo (Hb 10−13 g/dl [6,21 mmol/l do 8,07 mmol/l] in brez pomanjkanja železa), kadar niso izvedljivi postopki za konzerviranje krvi ali če ne zadoščajo za načrtovani večji kirurški poseg, za katerega je potrebna večja količina krvi (4 ali več enot krvi za ženske oz. 5 ali več enot za moške).
English: Do not take a double dose to make up for any forgotten doses.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjega.
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Slovenian: Neželeni učinki so navedeni po MedDRA organskih sistemih in kategorijah pogostnosti.
English: · Do not try to remove the used injection needle from the used syringe.
Slovenian: • Ne poskušajte odstraniti uporabljene injekcijske igle z injekcijske brizge.
English: A carcinogenicity study with homologous erythropoietin in mice did not reveal any signs of proliferative or tumourigenic potential.
Slovenian: Študija kancerogenosti s homolognim eritropoetinom pri miših ni odkrila proliferativnega ali tumorogenega delovanja.
English: Pharmacokinetic investigations in healthy volunteers and uraemic patients show that the half-life of intravenously administered epoetin beta is between 4 and 12 hours and that the distribution volume corresponds to one to two times the plasma volume.
Slovenian: Farmakokinetične raziskave pri zdravih prostovoljcih in uremičnih bolnikih so pokazale, da znaša razpolovni čas epoetina beta po intravenskem vnosu 4 do 12 ur, porazdelitveni volumen pa ustreza enkratnemu do dvakratnemu plazemskemu volumnu.
English: For storage conditions of the reconstituted medicinal product see section 6.3.
Slovenian: Za pogoje shranjevanja rekonstituiranega zdravila glejte poglavje 6.3.
English: Be careful when taking out the syringe.
Slovenian: Bodite previdni pri jemanju injekcijske brizge.
English: ·Do not inject into a muscle.
Slovenian: • Ne injicirajte v mišico.
English: INSTRUCTIONS ON USE (on the cover inside) Handling steps
Slovenian: NAVODILA ZA UPORABO (na notranji strani zloženke) Postopek ravnanja z zdravilom Glejte navodilo za uporabo
English: Hypertensive crisis with encephalopathy-like symptoms may occur and require the immediate attention of a physician and intensive medical care.
Slovenian: Lahko se pojavi hipertenzivna kriza s podobnimi simptomi kot pri encefalopatiji in takrat potrebuje bolnik takojšnjo zdravniško pomoč in intenzivno zdravstveno oskrbo.
English: When you donate blood, NeoRecormon will be given to you at the end of a donation session.
Slovenian: Ko boste darovali kri, boste prejeli zdravilo NeoRecormon ob koncu odvzema.
English: To avoid the risk of contamination of the contents always observe aseptic techniques (i.e. use disposable sterile syringes and needles to administer each dose) and strictly follow the handling instructions below.
Slovenian: Za preprečevanje tveganja navzkrižne kontaminacije vsebine je treba vedno zagotoviti aseptične pogoje (uporaba sterilnih brizg in igel za enkratno uporabo za vsak odmerek) in natančno slediti spodnjim navodilom za pripravo.
English: · in infants or young children up to 3 years, since NeoRecormon Multidose solvent contains benzyl alcohol as a preservative
Slovenian: • pri novorojenčkih ali otrocih do 3. leta starosti, ker vehikel zdravilaNeoRecormon za večodmerno raztopino za injiciranje vsebuje benzilalkohol kot konzervans.
English: NeoRecormon has not shown evidence of impaired fertility in animals.
Slovenian: Pri zdravilu NeoRecormon niso dokazali zmanjšane plodnosti pri živalih.
English: In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer.
Slovenian: Glede na zgoraj navedeno je treba v nekaterih kliničnih primerih anemijo pri bolnikih z rakom prednostno zdraviti s transfuzijo krvi.
English: Before withdrawing each dose disinfect the rubber seal of the withdrawal device with alcohol to prevent contamination of the contents by repeated needle insertions.
Slovenian: Pred odvzemom vsakega odmerka je treba površino gumijastega pokrova pripomočka za odvzem dezinficirati z alkoholom, da preprečimo kontaminacijo vsebine zaradi večkratnih vstavkov igel.
English: Folic acid and vitamin B12 deficiencies should be ruled out as they reduce the effectiveness of NeoRecormon.
Slovenian: Pred zdravljenjem moramo izključiti pomanjkanje folne kisline in vitamina B12, ker lahko zmanjša učinkovitost zdravila NeoRecormon.
English: Your doctor may initiate treatment with NeoRecormon if your haemoglobin level is 10 g/dL or less.
Slovenian: Zdravnik lahko uvede zdravljenje z zdravilom NeoRecormon, če je vaša koncentracija hemoglobina 10 g/dl ali manj.
English: · Rarely (may affect up to 1 in 1,000 people), allergies or skin reactions, such as rash or hives, itching or reactions around the injection site have occurred.
Slovenian: • Redko (pojavijo se lahko pri največ 1 od 1000 bolnikov) so se pojavile alergije ali kožne reakcije, kot kožni izpuščaj ali koprivnica, srbenje ali reakcije okoli mesta injiciranja.
English: Preparation of a single injection (1) Before withdrawing each dose disinfect the rubber seal of the device with alcohol.
Slovenian: Priprava enkratne injekcije (1) Pred odvzemom vsakega odmerka dezinficirajte gumijast pokrov pripomočka z alkoholom.
English: The clinical results obtained so far do not indicate any interaction of NeoRecormon with other medicinal products.
Slovenian: Dozdajšnji klinični izsledki ne kažejo na interakcije med zdravilom NeoRecormon in drugimi zdravili.
English: · People donating their own blood before surgery Injections are given into a vein over 2 minutes, or under the skin.
Slovenian: • Osebe, ki darujejo svojo kri pred operacijo Injekcije dajemo v veno približno 2 minuti ali pod kožo.
English: If your body produces neutralising antibodies, your doctor will discontinue therapy with NeoRecormon, and determine the best course of action to treat your anaemia.
Slovenian: Če vaše telo tvori nevtralizirajoča protitelesa, vam bo zdravnik ukinil zdravljenje z zdravilom NeoRecormon, in določil najboljše ukrepe za zdravljenje vaše slabokrvnosti.
English: In very rare cases, epoetin beta treatment-related anaphylactoid reactions have been reported.
Slovenian: V zelo redkih primerih so poročali o anafilaktičnih reakcijah, povezanih z zdravljenjem z epoetinom beta.