FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should be exercised with escalation of MIRCERA 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 povečevanju odmerkov zdravila Mircera pri bolnikih s kronično ledvično odpovedjo je potrebna previdnost, ker so veliki kumulativni odmerki epoetina lahko povezani s povečanjem tveganja umrljivosti, resnih srčnožilnih in možganskožilnih dogodkov.
English: MIRCERA is a medicine produced by gene-technology.
Slovenian: Zdravilo MIRCERA je pridobljeno z gensko tehnologijo.
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 kontrolirani študiji s 4.038 bolniki s kronično ledvično boleznijo, ki niso bili na dializi in s sladkorno boleznijo tipa 2, ter koncentracijo hemoglobina ≤ 11 g/dl, so bolniki prejeli zdravljenje z darbepoetinom alfa, da bi dosegli koncentracijo hemoglobina 13 g/dl, ali placebo (glejte poglavje 4.4).
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: Poleg tega je treba posodobljen RMP predložiti: · na zahtevo Evropske agencije za zdravila; · ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: This may be associated with life-threatening cardiovascular complications.
Slovenian: To je lahko povezano s smrtno nevarnimi zapleti v srčnožilnem sistemu.
English: MIRCERA is not approved for treatment of patients with chemotherapy induced anaemia (see section 4.1 and 4.4.
Slovenian: Zdravilo MIRCERA ni odobreno za zdravljenje bolnikov z anemijo, ki je posledica kemoterapije (glejte poglavji 4.1 in 4.4).
English: If you are advised to inject MIRCERA under your skin, please administer your dose as described below.
Slovenian: Če so vam svetovali, da si injicirate zdravilo MIRCERA pod kožo, si odmerek dajte, kot je opisano spodaj.
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 alfa kažejo, da je pogostnost kapi pogosta.
English: • Your doctor will check that your haemoglobin does not exceed a certain level, as high haemoglobin could put you at risk of having a problem of the heart or the blood vessels and could increase risk of thrombosis, including pulmonary embolism, myocardial infarction, stroke and death.
Slovenian: · Zdravnik bo pazil, da koncentracija vašega hemoglobina ne bo narastla nad določeno vrednost, saj bi bili zaradi velike koncentracije hemoglobina lahko ogroženi zaradi težav s srcem ali krvnimi žilami, povečalo pa bi se lahko tudi tveganje za trombozo, vključno s pljučnim embolizmom, miokardni infarkt, kap in smrt.
English: Like the natural hormone erythropoietin, MIRCERA increases the number of red blood cells and haemoglobin level in your blood.
Slovenian: Kot naravni hormon eritropoetin tudi zdravilo MIRCERA poveča število rdečih krvnih celic in koncentracijo hemoglobina v krvi.
English: The following instructions explain how to use the MIRCERA pre-filled syringe to give yourself an injection.
Slovenian: Naslednja navodila opisujejo, kako uporabljati napolnjeno injekcijsko brizgo zdravila MIRCERA in kako si dati injekcijo.
English: Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, poloxamer 188 and water for injections.
Slovenian: Natrijev dihidrogenfosfat monohidrat, natrijev sulfat, manitol (E 421), metionin, poloksamer 188 in voda za injekcije.
English: Treatment with MIRCERA has to be initiated under the supervision of a physician experienced in the management of patients with renal impairment.
Slovenian: Zdravljenje z zdravilom MIRCERA je treba uvesti pod nadzorom zdravnika z izkušnjami pri zdravljenju bolnikov z ledvično okvaro.
English: • Your doctor will check your blood pressure before and during your MIRCERA treatment.
Slovenian: · Zdravnik vam bo preverjal krvni tlak pred in med zdravljenjem z zdravilom MIRCERA.
English: Place a sterile cotton ball or gauze over the injection site and press for several seconds.
Slovenian: Postavite sterilno vato ali gazo na mesto injiciranja in pritisnite za nekaj sekund.
English: MIRCERA is indicated to treat only the symptomatic anaemia caused by chronic kidney disease.
Slovenian: Zdravilo MIRCERA uporabljamo le za zdravljenje simptomatske anemije, ki jo povzroča kronična ledvična bolezen.
English: Your doctor will check that you do not have other causes of anaemia and may perform blood tests or examine your bone marrow.
Slovenian: Zdravnik bo preveril, če obstaja drug vzrok anemije, morda vas bo napotil na preiskave krvi ali kostnega mozga.
English: IMPORTANT INFORMATION · Only use MIRCERA pre-filled syringeif you have been prescribed with this · medication.
Slovenian: POMEMBNE INFORMACIJE · Uporabljajte le napolnjeno injekcijsko brizgo zdravila MIRCERA, ki vam je bila predpisana.
English: Store the syringe in its original box until ready to use.
Slovenian: Injekcijsko brizgo shranjujte v originalni ovojnini, dokler ni pripravljena za uporabo.
English: It is unknown whether MIRCERA is excreted in human breast milk.
Slovenian: Ni znano, če zdravilo MIRCERA prehaja v materino mleko.
English: If your blood pressure is high and cannot be controlled, either by appropriate medicines or a special diet, your doctor will interrupt your MIRCERA treatment or reduce the dose.
Slovenian: Če bo krvni tlak visok in ga ne bo mogoče uravnati z ustreznimi zdravili ali dieto, bo zdravnik zdravljenje z zdravilom MIRCERA prekinil ali pa bo zmanjšal njegov odmerek.
English: · Not allowing the medicine to come to room temperature could result in an uncomfortable injection, and it may be difficult to depress the plunger.
Slovenian: · Če se zdravilo ne bo segrelo na sobno temperaturo, lahko pride do neprijetnega injiciranja in težav pri sproščanju bata.
English: Intravenous route:
Slovenian: Intravenska pot:
English: The safety data base from clinical trials comprised 3,042 CKD patients, including 1,939 patients treated with MIRCERA and 1,103 with another ESA.
Slovenian: Podatke o varnosti v kliničnih preskušanjih so pridobili pri 3.042 bolnikih s kronično ledvično boleznijo; od tega jih je bilo 1.939 zdravljenih z zdravilom MIRCERA, 1.103 pa z drugimi zdravili, ki spodbujajo eritropoezo.
English: Perform the injection
Slovenian: KAKO SI DATI INJEKCIJO
English: Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Slovenian: Zaradi variabilnosti med bolniki lahko občasno opazimo, da je koncentracija hemoglobina posameznega bolnika nad ali pod želeno.
English: A comparison of serum concentrations of methoxy polyethylene glycol-epoetin beta measured before and after haemodialysis in 41 CKD patients showed that haemodialysis has no effect on the pharmacokinetics of this medicinal product.
Slovenian: Primerjava serumskih koncentracij metoksipolietilenglikol epoetina beta, ki so jih izmerili pred hemodializo in po njej pri 41 bolnikih s kronično ledvično boleznijo, je pokazala, da hemodializa na farmakokinetiko tega zdravila ne vpliva.
English: Other medicines and MIRCERA
Slovenian: Druga zdravila in zdravilo MIRCERA
English: • Your doctor may initiate treatment with MIRCERA if your haemoglobin level is 10 g/dl (6.21 mmol/l) or less.
Slovenian: · Vaš zdravnik lahko uvede zdravljenje z zdravilom MIRCERA, če je vaša koncentracija hemoglobina 10 g/dl (6,21 mmol/l) ali manj.
English: A decision on whether to continue or discontinue breast-feeding or to continue or discontinue therapy with MIRCERA should be made taking into account the benefit of breast-feeding to the child and the benefit of MIRCERA therapy to the woman.
Slovenian: Pri odločitvi o nadaljevanju ali ukinitvi zdravljenja z zdravilom MIRCERA je treba presoditi glede na koristi dojenja za otroka in koristi zdravljenja z zdravilom MIRCERA za mater.
English: Physicians may request the Marketing Authorisation Holder to test or re-test serum samples in a reference laboratory for cases of suspected or confirmed AEAB-mediated PRCA or unexplained loss of effect under MIRCERA treatment (e.g. observed clinically by severe anaemia and low reticulocyte count).
Slovenian: Zdravniki lahko od imetnika dovoljenja za promet z zdravilom zahtevajo testiranje ali ponovno testiranje vzorcev seruma v referenčnem laboratoriju za primere suma ali potrjene čiste aplazije rdečih krvnih celic, povzročene s protitelesi proti eritropoetinu, ali nepojasnjene izgube učinka pri zdravljenju z zdravilom MIRCERA (npr. klinično opaženo kot huda anemija in majhno število retikulocitov).
English: If the amount is too low your doctor may give you an additional iron supplement.
Slovenian: Če bo koncentracija premajhna, vam lahko predpiše dodatno zdravljenje z železovim pripravkom.
English: Remove the box containing the MIRCERA pre-filled syringe from the refrigerator.
Slovenian: Škatlo, ki vsebuje napolnjeno injekcijsko brizgo zdravila MIRCERA, vzemite iz hladilnika.
English: A patient-level data analysis has also been performed on more than 13,900 cancer patients (chemo-, radia-, chemoradia-, or no therapy) participating in 53 controlled clinical trials involving several epoetins.
Slovenian: Pri več kot 13.900 bolnikih z rakom (na kemoterapiji, radioterapiji, kemoradioterapiji ali brez terapije), ki so sodelovali v 53 nadzorovanih kliničnih preskušanjih, ki vključujejo več epoetinov, so izvedli tudi analizo podatkov na nivoju posameznega bolnika.
English: After initiation of therapy, your doctor will seek to maintain your haemoglobin level between 10 and 12 g/dl (7.45 mmol/l).
Slovenian: Po začetku zdravljenja bo zdravnik skušal vzdrževati vašo koncentracijo hemoglobina med 10 in 12 g/dl (7,45 mmol/l).
English: METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous or intravenous use Read the package leaflet before use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Za subkutano ali intravensko uporabo Pred uporabo preberite priloženo navodilo
English: After dose interruption a haemoglobin decrease of approximately 0.35 g/dl (0.22 mmol/l) per week is expected.
Slovenian: Po prekinitvi dajanja je pričakovani padec koncentracije hemoglobina približno 0,35 g/dl (0,22 mmol/l) na teden.
English: Your doctor will carry out regular blood tests to monitor how your anaemia is responding to treatment by measuring your haemoglobin level.
Slovenian: Zdravnik vas bo redno napotil na krvne preiskave (merjenje koncentracije hemoglobina), da bo spremljal, kako se vaša anemija odziva na zdravljenje.
English: Driving and using machines MIRCERA does not affect your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo MIRCERA ne vpliva na vašo sposobnost upravljanja vozil in strojev.
English: The strength indicates the quantity of the protein moiety of the methoxy polyethylene glycol-epoetin beta molecule without consideration of the glycosylation.
Slovenian: Jakost se nanaša na vsebnost proteinskega dela molekule metoksipolietilenglikol epoetina beta brez upoštevanja glikozilacije.
English: • If you are a patient with hepatitis C and you receive interferon and ribavirin you should discuss this with your doctor because a combination of ESAs with interferon and ribavirin has lead to a loss of effect and development of PRCA, a severe form of anemia, in rare cases.
Slovenian: · Če imate hepatitis C in prejemate interferon ter ribavirin se morate o tem pogovoriti z zdravnikom, saj kombinacija zdravil za spodbujanje eritropoeze z interferonom in ribavirinom lahko v redkih primerih privede do izgube učinka in razvoja čiste aplazije rdečih krvnih celic,
English: Do not release the plunger before the end of injection or before the plunger is completely depressed.
Slovenian: Bata ne sprostite do konca injiciranja oziroma dokler bat ni pritisnjen do konca.
English: When MIRCERA was administered subcutaneously to male and female rats prior to and during mating, reproductive performance, fertility, and sperm assessment parameters were not affected.
Slovenian: Ko so zdravilo MIRCERA dajali subkutano podganjim samcem in samicam pred parjenjem in po njem, ni bilo vpliva na ocenjevane parametre za sposobnost razmnoževanja, plodnost in seme.
English: · Do not touch the release clips of the safety device.
Slovenian: · Ne dotikajte se sprostitvenih sponk na varnostnem pripomočku.
English: Patients should be monitored closely to ensure that the lowest approved effective dose of MIRCERA is used to provide adequate control of the symptoms of anaemia whilst maintaining a haemoglobin concentration below or at 12 g/dl (7.45 mmol/l).
Slovenian: Bolnike je treba pozorno spremljati, da lahko z najmanjšim odobrenim učinkovitim odmerkom zdravila Mircera simptome anemije ustrezno nadzorujemo in hkrati vzdržujemo koncentracijo hemoglobina pod 12 g/dl (7,45 mmol/l) ali na tej vrednosti.
English: · The contents are cloudy, hazy or contain particles.
Slovenian: · je vsebina motna ali vsebuje vidne delce.
English: In case of excessive haemoglobin levels, treatment with MIRCERA should be temporarily discontinued (see section 4.2).
Slovenian: Kadar so koncentracije hemoglobina prevelike, je treba zdravljenje z zdravilom MIRCERA začasno prekiniti (glejte poglavje 4.2).
English: If your healthcare professional has recommended injection of MIRCERA into a vein, you should follow the procedure described below.
Slovenian: Če vam je zdravnik svetoval dajanje zdravila MIRCERA v veno, sledite spodaj opisanemu postopku.
English: If all the conditions mentioned are excluded and the patient has a sudden drop of haemoglobin associated with reticulocytopenia and anti-erythropoietin antibodies, examination of the bone marrow for the diagnosis of Pure Red Cell Aplasia (PRCA) should be considered.
Slovenian: Če ste izključili vsa omenjena stanja in se pri bolniku pojavi nenaden padec koncentracije hemoglobina, povezan z retikulocitopenijo in protitelesi proti eritropoetinu, pride v poštev pregled kostnega mozga zaradi možne diagnoze čiste aplazije rdečih celic.
English: · Do not use the pre-filled syringe if syringe, or the plastic tray containing the syringe appears to be damaged.
Slovenian: · Ne uporabljajte napolnjene injekcijske brizge, če je napolnjena injekcijska brizga ali plastičen omot, ki jo vsebuje, poškodovan.
English: • If you get any side effects, talk to your doctor.
Slovenian: · Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
English: The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 62% and the observed terminal elimination half-life was 139 hours in CKD patients on dialysis.
Slovenian: Absolutna biološka uporabnost metoksipolietilenglikol epoetina beta po subkutanem dajanju je bila 62 %, ugotovljeni končni razpolovni čas izločanja pri dializnih bolnikih s kronično ledvično boleznijo pa 139 ur.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentialy sodium free.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na ml, kar v bistvu pomeni brez natrija.
English: Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid puncture of peripheral veins.
Slovenian: Pri bolnikih, ki niso na dializi, dajemo prednost subkutanemu dajanju, saj se tako izognemo punkciji perifernih ven.
English: Pre-filled syringe (type I glass) with laminated plunger stopper (bromobutyl rubber) and tip cap (bromobutyl rubber) and a needle 27G1/2.
Slovenian: Napolnjena injekcijska brizga (steklo tip I) z laminiranim zamaškom in batom iz brombutilne gume in pokrovom na vrhu (iz brombutilne gume) ter iglo 27G1/2.
English: The solution is clear, colourless to slightly yellowish and free of visible particles.
Slovenian: Raztopina je bistra, brezbarvna do rahlo rumenkasta in brez vidnih delcev.
English: In clinical trials, an increased risk of death, serious cardiovascular events including thrombosis or cerebrovascular events including stroke was observed when ESAs were administered to target a haemoglobin of greater than 12 g/dl (7.5 mmol/l) (see section 4.8).
Slovenian: V kliničnih preskušanjih so opazili povečano tveganje za smrt in resne srčnožilne dogodke, vključno s trombozo ali cerebrovaskularne dogodke, vključno s kapjo, če je bila ciljna koncentracija hemoglobina dosežena z zdravili za stimulacijo eritropoeze (ESA) nad 12 g/dl (7,5 mmol/l) (glejte poglavje 4.8).
English: Table 1: MIRCERA starting doses Previous weekly darbepoetin alfa intravenous or subcutaneous dose (microgram/week)
Slovenian: Preglednica 1: Uvajalni odmerki zdravila MIRCERA Prejšnji tedenski odmerek darbepoetina alfa, dan intravensko ali subkutano (mikrogram/teden)
English: Dose changes will not be made more often than once a month.
Slovenian: Odmerka ne bo spreminjal več kot enkrat na mesec.
English: If you use more MIRCERA than you should
Slovenian: MIRCERA, kot bi smeli.
English: There was however a class-related reversible reduction in foetal weight and a decrease in postnatal body-weight gain of offspring at the doses causing exaggerated pharmacodynamic effects in mothers.
Slovenian: Prišlo pa je do reverzibilnega zmanjšanja mase zarodka, ki je značilno za to skupino zdravil in do upada postnatalnega prirasta telesne mase potomcev ob odmerkih, ki so pri samicah povzročili pretirano farmakološko delovanje.
English: Grasp the syringe and the rubber tip cap firmly and remove the rubber tip cap from the syringe (bend and pull).
Slovenian: Trdno primite injekcijsko brizgo in gumijasti pokrovček ter odstranite gumijasti pokrovček z injekcijske brizge (upognite in povlecite).
English: MIRCERA has not been studied in pregnant or breast-feeding women.
Slovenian: Zdravila MIRCERA niso raziskali pri nosečnicah ali doječih materah.
English: Previous weekly epoetin intravenous or subcutaneous dose (IU/week)
Slovenian: Prejšnji tedenski odmerek epoetina, dan intravensko ali subkutano (i.e./teden)
English: · Do not push the plunger.
Slovenian: · Ne potegujte bata.
English: Monthly MIRCERA intravenous or subcutaneous dose (microgram/once monthly)
Slovenian: Mesečni odmerek zdravila MIRCERA, dan intravensko ali subkutano (mikrogram/enkrat na mesec)
English: SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Slovenian: SJS/TEN se lahko pojavita kot rdečkaste, tarčam podobne makule ali okrogle lise po telesu, pogosto z mehurjem na sredini.
English: A rise in haemoglobin of greater than 2 g/dl (1.24 mmol/l) over a four-week period should be avoided.
Slovenian: Povečanju koncentracije hemoglobina za več kot 2 g/dl (1,24 mmol/l) v štirih tednih se je treba izogibati.
English: In responding to hypoxia, the natural hormone erythropoietin interacts with erythroid progenitor cells to increase red cell production.
Slovenian: V odgovoru na hipoksijo pride do interakcije med naravnim hormonom eritropoetinom in progenitornimi matičnimi celicami za eritrocite, kar poveča tvorbo rdečih krvnih celic.
English: The dose is to be administered once every two weeks as a single injection under the skin or into a vein.
Slovenian: Odmerek boste dobili enkrat na dva tedna kot eno injekcijo pod kožo ali v veno.
English: Effect on tumour growth: MIRCERA, like other ESAs, is a growth factor that primarily stimulates red blood cell production.
Slovenian: Vpliv na rast tumorja: Tudi MIRCERA je kot druga zdravila, ki spodbujajo eritropoezo, rastni dejavnik, ki primarno spodbuja nastajanje rdečih krvnih celic.
English: In a single dose study, after intravenous administration, the pharmacokinetics of methoxy polyethylene glycol-epoetin beta are similar in patients with severe hepatic impairment as compared to healthy subjects (see section 4.2).
Slovenian: V študiji enkratnega odmerjanja je bila po intravenskem dajanju zdravila farmakokinetika metoksipolietilenglikol epoetina beta pri bolnikih s hudo jetrno okvaro podobna tisti pri zdravih osebah (glejte poglavje 4.2).
English: If you miss a dose of MIRCERA administer the missed dose as soon as you remember and talk to your doctor about when to use the next doses.
Slovenian: Če ste pozabili uporabiti zdravilo MIRCERA Če ste izpustili odmerek zdravila MIRCERA, si izpuščeni odmerek injicirajte takoj, ko se spomnite, in se pogovorite z zdravnikom o tem, kdaj naj uporabite naslednje odmerke.
English: One animal study has shown excretion of methoxy polyethylene glycol-epoetin beta in maternal milk.
Slovenian: V eni študiji na živalih so pokazali izločanje metoksipolietilenglikol epoetina beta v mleko samic.
English: PRCA in patients with Hepatitis C: A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform anti-erythropoietin antibody testing.
Slovenian: Čista aplazija rdečih krvnih celic pri bolnikih s hepatitisom C: Paradoksno znižanje vrednosti hemoglobina in razvoj hude anemije povezane z nizkim številom retikulocitov zahteva takojšnjo prekinitev zdravljenja z epoetinom in testiranje na protitelesa proti eritropoetinu.
English: · Do not use the syringe if the contents are cloudy, hazy or contain particles.
Slovenian: · Ne uporabljajte injekcijske brizge, če je njena vsebina motna ali vsebuje delce.
English: · Be sure not to touch the cleaned area prior to the injection and do not fan or blow on the clean area.
Slovenian: · Ne dotikajte se očiščene površine pred injiciranjem ter ne pihajte nanjo.
English: Wipe off the venous port of the hemodialysis as instructed by your healthcare provider
Slovenian: Očistite venski dostop pri hemodializni krvni liniji, kot vam je naročil zdravstveni delavec.
English: If you develop a serious rash or another of these skin symptoms stop taking Mircera and contact your doctor or seek medical attention immediately.
Slovenian: Če se pojavi hud izpuščaj ali drugi kožni simptomi, prenehajte uporabljati zdravilo Mircera in nemudoma obvestite zdravnika ali poiščite zdravniško pomoč.
English: Release the plunger, allowing the needle guard to protect the needle.
Slovenian: Sprostite bat in s tem bo varovalo za iglo zaščitilo iglo.
English: MIRCERA can be injected under the skin in the abdomen, arm or thigh; or into a vein.
Slovenian: Zdravilo MIRCERA lahko injiciramo pod kožo v trebuh, roko ali stegno ali pa v veno.
English: Insert the needle of the pre-filled syringe into the cleaned venous port.
Slovenian: Vstavite iglo napolnjene injekcijske brizge v očiščen venski dostop.
English: The pharmacokinetics of methoxy polyethylene glycol-epoetin beta were studied in healthy volunteers and in anaemic patients with CKD including patients on dialysis and not on dialysis.
Slovenian: Farmakokinetiko metoksipolietilenglikol epoetina beta so raziskali pri zdravih prostovoljcih in anemičnih bolnikih s kronično ledvično boleznijo, ki so bili na dializi ali pa ne.
English: MIRCERA is not recommended for use in children and adolescents below 18 years due to a lack of safety and efficacy data.
Slovenian: Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila MIRCERA pri otrocih in mladostnikih, mlajših od 18 let, ni priporočljiva.