FrancophonIA/ELRC3.0 huggingface dataset:
English: MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe 40 micrograms/0.3 ml solution for injection in pre-filled syringe 50 micrograms/0.3 ml solution for injection in pre-filled syringe 60 micrograms/0.3 ml solution for injection in pre-filled syringe 75 micrograms/0.3 ml solution for injection in pre-filled syringe 100 micrograms/0.3 ml solution for injection in pre-filled syringe 120 micrograms/0.3 ml solution for injection in pre-filled syringe 150 micrograms/0.3 ml solution for injection in pre-filled syringe 200 micrograms/0.3 ml solution for injection in pre-filled syringe 250 micrograms/0.3 ml solution for injection in pre-filled syringe 360 micrograms/0.6 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Slovenian: MIRCERA 30 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 40 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 50 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 60 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 75 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 100 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 120 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 150 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 200 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 250 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 360 mikrogramov/0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment (see section 4.8).
Slovenian: V povezavi z zdravljenjem z epoetini so poročali o hudih kožnih neželenih učinkih, vključno s Stevens-Johnsonovim sindromom (SJS) in toksično epidermalno nekrolizo (TEN), ki sta lahko življenjsko ogrožajoča ali smrtna (glejte poglavje 4.8).
English: · Do not swallow the medicine in the syringe.
Slovenian: · Ne pogoltnite zdravila, ki se nahaja v napolnjeni injekcijski brizgi.
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih občasni tromboza žilnega pristopa
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal
Slovenian: določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7)
English: MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2.
Slovenian: Zdravilo MIRCERA je na voljo v napolnjenih injekcijskih brizgah z laminiranim zamaškom in batom ter pokrovom na vrhu in eno injekcijsko iglo 27G1/2.
English: Neutralising anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) has been reported, frequency unknown.
Slovenian: Poročali so o čisti aplaziji rdečih krvnih celic, povzročeni z nevtralizirajočimi protitelesi proti eritropoetinu; pogostnost ni znana.
English: Analysis of the individual components of the composite endpoints showed the following HR (95% CI): death 1.05 (0.92, 1.21), stroke 1.92 (1.38, 2.68), congestive heart failure (CHF) 0.89 (0.74, 1.08), myocardial infarction (MI) 0.96 (0.75, 1.23), hospitalisation for myocardial ischaemia 0.84 (0.55, 1.27), ESRD 1.02 (0.87, 1.18).
Slovenian: Analiza posameznih komponent sestavljene končne točke je pokazala sledeče razmerje ogroženosti (95-% interval zaupanja): smrt 1,05 (0,92, 1,21), kap 1,92 (1,38, 2,68), kongestivno srčno popuščanje (KSP)
English: Pure Red Cell Aplasia caused by anti-erythropoietin antibodies has been reported in association with all ESAs, including MIRCERA.
Slovenian: Čista aplazija rdečih krvnih celic zaradi protiteles proti eritropoetinu je opisana v povezavi z vsemi zdravili, ki spodbujajo eritropoezo, vključno z zdravilom MIRCERA.
English: Patients not currently treated with an erythropoiesis stimulating agent (ESA): In order to increase haemoglobin levels to greater than 10 g/dl (6.21 mmol/l), the recommended starting dose in patients not on dialysis is 1.2 microgram/kg body weight, administered once every month as a single subcutaneous injection.
Slovenian: Da bi povečali koncentracijo hemoglobina nad 10 g/dl (6,21 mmol/l), se pri nedializnih bolnikih priporoča začetni odmerek 1,2 mikrograma/kg telesne mase enkrat na mesec v obliki ene subkutane injekcije.
English: MIRCERA is available, for all strengths, in pack sizes of 1 and also packsize of 3 for the strengths 30, 50, 75 micrograms/0.3ml.
Slovenian: Zdravilo MIRCERA je na voljo v pakiranju po 1 za vse jakosti in pakiranju po 3 napolnjene injekcijske brizge, za jakosti 30, 50, 75 mikrogramov/0,3 ml. Na trgu ni vseh navedenih pakiranj.
English: · Do not try to replace the shield on the needle.
Slovenian: · Ne poskušajte zamenjati varovala na igli.
English: STORAGE Keep the syringe and the puncture-resistant/ sharps container out of the reach of children.
Slovenian: Injekcijsko brizgo in vsebnik za odpadni material, ki je odporen proti vbodom, shranjujte nedosegljivo otrokom.
English: Remove the plastic tray of the MIRCERA pre-filled syringe from the box without peeling back the protective film.
Slovenian: Iz škatle vzemite plastični omot z zdravilom MIRCERA, vendar zaščitne prevleke še ne odstranjujte.
English: • The active substance is methoxy polyethylene glycol-epoetin beta.
Slovenian: · Učinkovina je metoksipolietilenglikol epoetin beta.
English: *Protein produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells and covalently conjugated to a linear methoxy-polyethylene glycol (PEG).
Slovenian: *Beljakovina, pridobljena iz celične kulture jajčnika kitajskega hrčka s tehnologijo rekombinantne
English: Pre-filled syringe 360 micrograms contains 0.6 ml solution.
Slovenian: 360-mikrogramska napolnjena injekcijska brizga vsebuje 0,6 ml raztopine.
English: · Do not try to replace the needle shield on the needle.
Slovenian: · Ne poskušajte zamenjati igelne zaščite na igli.
English: These antibodies have been shown to cross-react with all ESAs, and patients suspected or confirmed to have antibodies to erythropoietin should not be switched to MIRCERA (see section 4.8).
Slovenian: Bolniki, pri katerih obstaja sum ali je potrjeno, da imajo protitelesa proti eritropoetinu, naj ne bi prešli na zdravilo MIRCERA (glejte poglavje 4.8).
English: Caution should be exercised with escalation of MIRCERA doses in patients with chronic renal failure.
Slovenian: Pri povečevanju odmerkov zdravila Mircera pri bolnikih s kronično ledvično odpovedjo je potrebna previdnost.
English: · Do not inject areas that could be irritated by a belt or waistband.
Slovenian: · Ne injicirajte na mesta, kjer bi lahko pas dražil kožo.
English: Allow the pre-filled syringe to reach room temperature before injecting.
Slovenian: Pred injiciranjem mora napolnjena injekcijska brizga imeti sobno temperaturo.
English: Break the seal of the needle, using a twisting motion, and remove the needle cap as pictured.
Slovenian: Z zasukom pretrgajte zaščitno oznako in odstranite pokrovček, kot je prikazano na sliki.
English: Survival and tumour progression have been examined in five large controlled studies involving a total of 2,833 patients, of which four were double-blind placebo-controlled studies and one was an openlabel study.
Slovenian: V petih velikih, kontroliranih študijah, ki so skupaj zajele 2.833 bolnikov, so preiskovali preživetje in napredovanje tumorja.
English: The therapeutic range of MIRCERA is wide.
Slovenian: 4.9 Preveliko odmerjanje Zdravilo MIRCERA ima široko terapevtsko okno.
English: The dose is to be administered once every two weeks as a single injection under the skin orinto a vein.
Slovenian: Odmerek boste dobili enkrat na mesec kot eno injekcijo pod kožo.
English: Patients were randomized to stay on their treatment at the time of enrollment or to be switched to MIRCERA in order to maintain stable haemoglobin levels.
Slovenian: Bolnike so razvrstili tako, da so ostali na zdravljenju, ki so ga prejemali ob času vstopa v raziskavo ali pa so prešli na zdravilo
English: There is no evidence that MIRCERA interacts with other medicines.
Slovenian: Za medsebojno delovanje zdravila MIRCERA z drugimi zdravili ni dokazov.
English: Failure to respond to MIRCERA therapy should prompt for a search for causative factors.
Slovenian: Če je bolnik neodziven na zdravljenje z zdravilom MIRCERA, je treba ugotoviti vzročne dejavnike.
English: What MIRCERA contains
Slovenian: Kaj vsebuje zdravilo MIRCERA
English: Patients treated once every two weeks whose haemoglobin concentration is above 10 g/dl (6.21 mmol/l) may receive MIRCERA administered once-monthly using the dose equal to twice the previous once-every-two-week dose.
Slovenian: Ko bolniki, ki so prejemali zdravilo enkrat na dva tedna, dosežejo koncentracijo hemoglobina nad 10 g/dl (6,21 mmol/l), lahko zdravilo MIRCERA prejmejo enkrat na mesec.
English: No significant placental transfer of methoxy polyethylene glycol-epoetin beta was observed in the rat, and studies in animals have not shown any harmful effect on pregnancy, embryofoetal development, parturition or postnatal development.
Slovenian: Raziskave na živalih niso pokazale škodljivih vplivov na brejost, razvoj zarodka/plodu, porod ali postnatalni razvoj.
English: Four randomized controlled studies were performed in dialysis patients currently treated with darbepoetin alfa or epoetin at the time of enrollment.
Slovenian: Pri dializnih bolnikih, ki so se v času vključevanja v raziskavo zdravili z darbepoetinom alfa ali epoetinom, so opravili štiri randomizirane kontrolirane klinične raziskave.
English: If the haemoglobin level continues to increase, therapy should be interrupted until the haemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose.
Slovenian: Če se koncentracija hemoglobina še vedno povečuje, zdravljenje prekinite, dokler koncentracija hemoglobina ne začne padati.
English: Non-clinical data show no special hazard for humans based on conventional studies of cardiovascular safety pharmacology, repeat dose toxicity and reproductive toxicity.
Slovenian: 5.3 Predklinični podatki o varnosti Predklinični podatki na osnovi običajnih raziskav o farmakološki varnosti za srce in ožilje, toksičnosti ob ponavljajočih se odmerkih in vplivu na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
English: Do not move the needle while it is inserted in the skin
Slovenian: Medtem ko je igla zapičena v koži, je ne premikajte.
English: Treatment of symptomatic anaemia in adult chronic kidney disease patients Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician's evaluation of the individual patient's clinical course and condition is necessary.
Slovenian: Simptomi in posledice anemije se lahko razlikujejo glede na starost, spol in celotno breme bolezni,
English: A slight decrease in platelet counts remaining within the normal range was observed in clinical studies.
Slovenian: V kliničnih preskušanjih so opazili rahel padec števila trombocitov, ki pa je ostal v mejah normale.
English: The safety and efficacy of MIRCERA therapy in other indications, including anaemia in patients with cancer, has not been established.
Slovenian: Varnosti in učinkovitosti zdravljenja z zdravilom MIRCERA niso raziskali pri drugih indikacijah,
English: A. MANUFACTURER (S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: PRILOGA II A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA
English: Methoxy polyethylene glycol-epoetin beta, the active substance of MIRCERA, is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to erythropoietin.
Slovenian: učinkovina zdravila MIRCERA, je stalni aktivator eritropoetinskega receptorja, ki ima v primerjavi z eritropoetinom drugačno delovanje na ravni receptorja.
English: Roche (Hellas) A.E. Τηλ: +30 210 61 66 100
Slovenian: Τηλ: +30 210 61 66 100
English: Keep the syringe in the box to protect it from light and allow it to reach room temperature for at least 30 minutes.
Slovenian: Škatlo pustite zunaj hladilnika vsaj 30 minut, da se segreje na sobno temperaturo.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
English: Always store the syringe in a refrigerator at a temperature of 2 - 8°C (35.6 - 46.4°F).
Slovenian: Vedno shranjujte injekcijsko brizgo v hladilniku pri temperaturi od 2-8 °C.
English: Sterile cotton ball or gauze Puncture-resistant container or sharps container for safe disposal of needle and used syringe
Slovenian: Vsebnik za odpadni material, ki je odporen proti vbodom za varno odlaganje uporabljene injekcijske brizge in igle.
English: Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients (see section 5.1).
Slovenian: Zdravljenje simptomatske anemije, povezane s kronično ledvično boleznijo pri odraslih bolnikih
English: In case PRCA is diagnosed, therapy with MIRCERA must be discontinued and patients should not be switched to another ESA.
Slovenian: V primeru potrditve diagnoze zdravljenje z zdravilom MIRCERA ukinemo, bolnikov pa naj ne bi prevedli na druga zdravila za stimulacijo eritropoeze.
English: Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dl (6.21 mmol/l) to 12 g/dl (7.45 mmol/l).
Slovenian: 10 g/dl (6,21 mmol/l) do 12 g/dl (7,45 mmol/l).
English: Do not shake
Slovenian: Ne zamrzujte
English: If signs and symptoms suggestive of these reactions appear, Mircera should be withdrawn immediately and an alternative treatement considered.If the patient has developed a severe cutaneous skin reaction such as SJS orTEN due to the use of Mircera, treatment with ESA must not be restarted in this patient at any time.
Slovenian: Če se pojavijo znaki in simptomi, ki nakazujejo na te reakcije, je treba zdravilo Mircera takoj ukiniti in razmisliti o alternativnem zdravljenju.
English: The dose may be increased by approximately 25% of the previous dose if the rate of rise in haemoglobin is less than 1.0 g/dl (0.621 mmol/l) over a month.
Slovenian: Če se je koncentracija hemoglobina v enem mesecu povečala za manj kot 1,0 g/dl (0,621 mmol/l),
English: INFORMATION IN BRAILLE mircera 75 mcg
Slovenian: PODATKI V BRAILLOVI PISAVI mircera 75 mcg
English: Patients currently treated with an ESA can be switched to MIRCERA administered once a month as a single intravenous or subcutaneous injection.
Slovenian: MIRCERA z odmerjanjem enkrat na mesec v eni intravenski ali subkutani injekciji.
English: INFORMATION IN BRAILLE mircera 120 mcg
Slovenian: PODATKI V BRAILLOVI PISAVI mircera 120 mcg
English: Tell your doctor if you are breast-feeding or intend to breast-feed.
Slovenian: Obvestite zdravnika, če dojite ali nameravate dojiti.
English: Following intravenous administration to CKD patients on dialysis, the total systemic clearance was 0.494 ml/h per kg.
Slovenian: Po intravenskem dajanju pri dializnih bolnikih s kronično ledvično boleznijo je skupni sistemski očistek znašal 0,494 ml/h na kg. Razpolovni čas izločanja po intravenskem vnosu metoksipolietilenglikol epoetina beta znaša 134 ur.
English: Throw away used syringes in a puncture-resistant container.
Slovenian: Uporabljene injekcijske brizge zavrzite v vsebnik, odporen proti vbodom.
English: INFORMATION IN BRAILLE mircera 360 mcg
Slovenian: PODATKI V BRAILLOVI PISAVI mircera 360 mcg
English: Elderly population
Slovenian: Starejši
English: Using it can lead to too high haemoglobin levels and cause problems with the heart or blood vessels that may be life-threatening.
Slovenian: · Zdravi ljudje ne smejo prejemati zdravila MIRCERA, ker bi lahko pretirano povečalo njihovo koncentracijo hemoglobina in povzročilo težave s srcem ali krvnimi žilami, ki so lahko življenjsko nevarne.
English: Further increases of approximately 25% may be made at monthly intervals until the individual target haemoglobin level is obtained.
Slovenian: Dokler bolniki ne dosežejo svojih ciljnih koncentracij hemoglobina, lahko odmerek povečujete po približno 25 % v mesečnih presledkih.
English: In a post-authorisation safety study with long treatment exposure of up to 8.4 years, baseline platelet counts below 100 x 109/l was present in 2.1% of patients in the MIRCERA group and 2.4% of patients in other ESAs group.
Slovenian: Število trombocitov v izhodišču pod 100 x 109/l je bilo prisotno pri 2,1 % bolnikov v skupini z zdravilom MIRCERA in 2,4 % bolnikov v skupini z drugimi zdravili za stimulacijo eritropoeze.
English: There have been reports of platelet counts below the normal range (thrombocytopenia) in the post-marketing setting.
Slovenian: Po prihodu zdravila na trg so poročali o številu trombocitov, ki je bilo nižje od normalne ravni (trombocitopenija).
English: INFORMATION IN BRAILLE mircera 200 mcg
Slovenian: PODATKI V BRAILLOVI PISAVI mircera 200 mcg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 360 micrograms pre-filled syringe
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 360 mikrogramov napolnjena injekcijska brizga
English: One pre-filled syringe contains: 30, 40, 50, 60, 75, 100, 120, 150, 200 or 250 micrograms in 0.3 ml and 360 micrograms in 0.6 ml.
Slovenian: Ena napolnjena injekcijska brizga vsebuje: 30, 40, 50, 60, 75, 100, 120, 150, 200 ali 250 mikrogramov učinkovine v 0,3 ml in 360 mikrogramov učinkovine v 0,6 ml. · Pomožne snovi so natrijev dihidrogenfosfat monohidrat, natrijev sulfat, manitol (E 421), metionin, poloksamer 188 in voda za injekcije.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 75 micrograms pre-filled syringe
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 75 mikrogramov napolnjena injekcijska brizga
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 360 mcg/0.6 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 360 µg/0,6 ml
English: Attach the needle to the syringe by pushing it firmly onto the syringe.
Slovenian: Na injekcijsko brizgo pritrdite iglo, tako da ju trdno pritisnete skupaj.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 75 mcg/0.3 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 75 µg/0,3 ml
English: Immediately throw away the needle cap in the sharps/ puncture-resistant container or sharps container.
Slovenian: Pokrovček igle nemudoma zavrzite v vsebnik za odpadni material, ki je odporen proti vbodom.
English: MIRCERA 250 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 250 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 833 micrograms/ml.
Slovenian: MIRCERA 250 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 250 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 833 mikrogramov/ml.
English: · Do not remove the needle shield that protects the needle.
Slovenian: · Zaščite na igli ne odstranite.
English: • hypertensive encephalopathy (very high blood pressure that can result in headache, especially sudden, stabbing, migraine-like headache, confusion, speech disturbances, fits or convulsions).
Slovenian: zbadajoč glavobol podoben migreni, zmedenost, motnje govora, epileptični napad ali krče); · pljučni embolizem; · makulopapulozni izpuščaj (rdeča kožna reakcija, ki lahko vključuje mozolje ali pege); · vročinski oblivi; · preobčutljivost (alergična reakcija, ki lahko povzroči nenavadno piskanje ali težave z dihanjem; otekel jezik, obraz ali grlo ali oteklino okoli mesta injiciranja; ali pa se lahko počutite omotično, omedlite ali pa se zgrudite).
English: Attach the needle to the syringe
Slovenian: Korak 4: Pritrdite iglo na injekcijsko brizgo
English: Each pack contains 3 pre-filled syringes of 0.3 ml and 3 needles
Slovenian: Eno pakiranje vsebuje 3 napolnjene injekcijske brizge za enkratno uporabo po 0,3 ml in 3 igle
English: MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 667 micgrograms/ml
Slovenian: MIRCERA 200 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 200 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 667 mikrogramov/ml.
English: This leaflet was last revised in {MM/YYYY}..
Slovenian: Navodilo je bilo odobreno {MM/LLLL}
English: • It is not known if MIRCERA has a different effect in patients with haemoglobinopathies (disorders associated with abnormal haemoglobin), past or present bleeding, seizures or with a high blood platelet count.
Slovenian: (motnja povezana z nenormalnim hemoglobinom), krvavitvijo v preteklosti ali sedanjosti,
English: INFORMATION IN BRAILLE mircera 250 mcg
Slovenian: PODATKI V BRAILLOVI PISAVI mircera 250 mcg
English: Do NOT use the syringe if: · You have accidentally dropped the syringe.
Slovenian: NE uporabite injekcijske brizge, če:
English: INFORMATION IN BRAILLE mircera 150 mcg
Slovenian: PODATKI V BRAILLOVI PISAVI mircera 150 mcg
English: (b) Tabulated list of adverse reactions
Slovenian: (b) Neželeni učinki, prikazani v preglednici
English: MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 500 micrograms/ml.
Slovenian: MIRCERA 150 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 150 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 500 mikrogramov/ml.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 mcg/0.3 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 120 µg/0,3 ml
English: MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 250 micrograms/ml
Slovenian: MIRCERA 75 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 75 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 250 mikrogramov/ml.
English: PHARMACEUTICAL FORM Solution for injection in pre-filled syringe (injection).
Slovenian: FARMACEVTSKA OBLIKA raztopina za injiciranje v napolnjeni injekcijski brizgi (injekcija) Raztopina je bistra in brezbarvna do rahlo rumenkasta.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 120 micrograms pre-filled syringe
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 120 mikrogramov napolnjena injekcijska brizga
English: INFORMATION IN BRAILLE mircera 30 mcg
Slovenian: PODATKI V BRAILLOVI PISAVI mircera 30 mcg