natgillin/translations-raw huggingface dataset:
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 
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.
This leaflet was last revised in {MM/YYYY}.. 
Navodilo je bilo odobreno {MM/LLLL}
• 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. 
(motnja povezana z nenormalnim hemoglobinom), krvavitvijo v preteklosti ali sedanjosti,
INFORMATION IN BRAILLE mircera 250 mcg 
PODATKI V BRAILLOVI PISAVI mircera 250 mcg
Do NOT use the syringe if: · You have accidentally dropped the syringe. 
NE uporabite injekcijske brizge, če:
INFORMATION IN BRAILLE mircera 150 mcg 
PODATKI V BRAILLOVI PISAVI mircera 150 mcg
(b) Tabulated list of adverse reactions 
(b) Neželeni učinki, prikazani v preglednici
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. 
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.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 mcg/0.3 ml 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 120 µg/0,3 ml
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 
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.
PHARMACEUTICAL FORM Solution for injection in pre-filled syringe (injection). 
FARMACEVTSKA OBLIKA raztopina za injiciranje v napolnjeni injekcijski brizgi (injekcija) Raztopina je bistra in brezbarvna do rahlo rumenkasta.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 120 micrograms pre-filled syringe 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 120 mikrogramov napolnjena injekcijska brizga
INFORMATION IN BRAILLE mircera 30 mcg 
PODATKI V BRAILLOVI PISAVI mircera 30 mcg
• If you are a patient with chronic renal failure, and particularly if you do not respond properly to MIRCERA, your doctor will check your dose of MIRCERA because repeatedly increasing your dose of MIRCERA if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death. 
· Če ste bolnik s kronično ledvično odpovedjo, in še posebej, če se ne odzivate ustrezno na zdravilo Mircera, bo zdravnik preveril vaš odmerek zdravila Mircera.
INFORMATION IN BRAILLE mircera 40 mcg 
PODATKI V BRAILLOVI PISAVI mircera 40 mcg
INFORMATION IN BRAILLE mircera 60 mcg 
PODATKI V BRAILLOVI PISAVI mircera 60 mcg
Each pack contains a pre-filled syringe of 0.6 ml and a needle 
Pakiranje vsebuje napolnjeno injekcijsko brizgo po 0,6 ml in iglo
A sustained haemoglobin level of greater than 12 g/dl (7.45 mmol/l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/dl (7.45 mmol/l) are observed are described below. 
Smernice za ustrezno prilagajanje odmerkov, ko koncentracija hemoglobina preseže 12 g/dl (7,45 mmol/l), so opisane spodaj.
MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 167 micrograms/ml. 
MIRCERA 50 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 50 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 167 mikrogramov/ml.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 30 micrograms 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 30 mikrogramov
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 mcg/0.3 ml 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 250 µg/0,3 ml
Animal studies do not indicate direct harmful effects with respect to pregnancy, embryofoetal development, parturition or postnatal development but indicate a class-related reversible reduction in foetal weight (see section 5.3). 
porod ali postnatalni razvoj; reverzibilno zmanjšanje plodove teže (glejte poglavje 5.3) pa nakazuje povezavo s to skupino zdravil.
INFORMATION IN BRAILLE mircera 100 mcg 
PODATKI V BRAILLOVI PISAVI mircera 100 mcg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 250 microgram pre-filled syringe 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 250 mikrogramov napolnjena injekcijska brizga
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta. 
Ena napolnjena injekcijska brizga vsebuje 75 mikrogramov metoksipolietilenglikol epoetina beta.
MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 120 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 400 micrograms/ml. 
MIRCERA 120 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 120 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 400 mikrogramov/ml.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/008 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/008
MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe One pre-filled syringe contains 360 micrograms of methoxy polyethylene glycol-epoetin beta*at a concentration of 600 micrograms/ml. 
MIRCERA 360 mikrogramov/0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 360 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 600 mikrogramov/ml.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 200 micrograms pre-filled syringe 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 200 mikrogramov napolnjena injekcijska brizga
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 150 microgram pre-filled syringe 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 150 mikrogramov napolnjena injekcijska brizga
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 150 mcg/0.3 ml 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 150 µg/0,3 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 75 micrograms 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 75 mikrogramov
How to store MIRCERA 
Shranjevanje zdravila MIRCERA
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 360 micrograms of methoxy polyethylene glycol-epoetin beta. 
Ena napolnjena injekcijska brizga vsebuje 360 mikrogramov metoksipolietilenglikol epoetina beta.
INFORMATION IN BRAILLE mircera 50 mcg 
PODATKI V BRAILLOVI PISAVI mircera 50 mcg
MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 133 micrograms/ml. 
MIRCERA 40 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 40 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 133 mikrogramov/ml.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mcg/0.3 ml 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 200 µg/0,3 ml
Skin and subcutaneous disorders 
Bolezni kože in podkožja redki makulopapulozni izpuščaj neznana
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 30 micrograms pre-filled syringe 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 30 mikrogramov napolnjena injekcijska brizga
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/009 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/009
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 100 microgram pre-filled syringe 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 100 mikrogramov napolnjena injekcijska brizga
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 50 micrograms pre-filled syringe 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 50 mikrogramov napolnjena injekcijska brizga
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 120 micrograms of methoxy polyethylene glycol-epoetin beta. 
Ena napolnjena injekcijska brizga vsebuje 120 mikrogramov metoksipolietilenglikol epoetina beta.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 360 mcg/0.6 ml injection methoxy polyethylene glycol-epoetin beta 
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 360 mg/0,6 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
NAME OF THE MEDICINAL PRODUCT MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 75 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
Do not freeze 
Ne stresajte
Step 6. 
Korak 6: Injiciranje
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 40 micrograms pre-filled syringe 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 40 mikrogramov napolnjena injekcijska brizga
NAME OF THE MEDICINAL PRODUCT MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 360 mikrogramov/0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 100 micrograms/ml 
MIRCERA 30 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 30 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 100 mikrogramov/ml.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 mcg/0.3 ml 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 30 µg/0,3 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 60 micrograms pre-filled syringe 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 60 mikrogramov napolnjena injekcijska brizga
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 50 micrograms 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 50 mikrogramov
MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 100 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 333 micrograms/ml. 
MIRCERA 100 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 100 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 333 mikrogramov/ml.
MIRCERA 60 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 60 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 200 micrograms/ml. 
MIRCERA 60 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 60 mikrogramov metoksipolietilenglikol epoetina beta* s koncentracijo 200 mikrogramov/ml.
Only one dose should be administered per syringe. 
Iz ene napolnjene injekcijske brizge lahko odvzamemo le en odmerek.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 120 micrograms PRE-FILLED SYRINGES LABEL 
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 120 mikrogramov
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mcg/0.3 ml 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 100 µg/0,3 ml
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 75 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 75 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta. 
Ena napolnjena injekcijska brizga vsebuje 200 mikrogramov metoksipolietilenglikol epoetina beta.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mcg/0.3 ml 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 60 µg/0,3 ml
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 120 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 120 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
6.6 Special precautions for disposal and other handling 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Napolnjena injekcijska brizga je pripravljena za uporabo.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/023 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/023
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta. 
Ena napolnjena injekcijska brizga vsebuje 150 mikrogramov metoksipolietilenglikol epoetina beta.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 150 micrograms PRE-FILLED SYRINGES LABEL 
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 150 mikrogramov
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 250 micrograms of methoxy polyethylene glycol-epoetin beta. 
Ena napolnjena injekcijska brizga vsebuje 250 mikrogramov metoksipolietilenglikol epoetina beta.
Each pack contains a pre-filled syringe of 0.3 ml and a needle 
Eno pakiranje vsebuje napolnjeno injekcijsko brizgo po 0,3 ml in iglo
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/018 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/018
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 50 mcg/0.3 ml 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 50 µg/0,3 ml
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/012 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/012
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/024 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/024
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/017 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/017
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta. 
Ena napolnjena injekcijska brizga vsebuje 30 mikrogramov metoksipolietilenglikol epoetina beta.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/022 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/022
NAME OF THE MEDICINAL PRODUCT MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 150 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 60 micrograms of methoxy polyethylene glycol-epoetin beta. 
Ena napolnjena injekcijska brizga vsebuje 60 mikrogramov metoksipolietilenglikol epoetina beta.
NAME OF THE MEDICINAL PRODUCT MIRCERA 250 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 250 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mcg/0.3 ml 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 40 µg/0,3 ml
To remove air bubbles from the prefilled syringe, hold the syringe with the needle pointing up. 
Držite injekcijsko brizgo z iglo obrnjeno navzgor, da boste odstranili zračne mehurčke iz injekcijske brizge.
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta. 
Ena napolnjena injekcijska brizga vsebuje 40 mikrogramov metoksipolietilenglikol epoetina beta.
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 100 micrograms of methoxy polyethylene glycol-epoetin beta. 
Ena napolnjena injekcijska brizga vsebuje 100 mikrogramov metoksipolietilenglikol epoetina beta.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/013 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/013
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 75 micrograms PRE-FILLED SYRINGES LABEL 
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 75 mikrogramov
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 250 micrograms PRE-FILLED SYRINGES LABEL 
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 250 mikrogramov
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/011 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/011
NAME OF THE MEDICINAL PRODUCT MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 120 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 200 micrograms PRE-FILLED SYRINGES LABEL 
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 200 mikrogramov
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 250 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 250 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/020 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/020
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 100 micrograms PRE-FILLED SYRINGES LABEL 
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 100 mikrogramov
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/019 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/019
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 200 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 200 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/021 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/021
NAME OF THE MEDICINAL PRODUCT MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 200 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
The median time to response was 43 days in the MIRCERA arm and 29 days in the comparator arm, with increases of haemoglobin within the first 6 weeks of 0.2 g/dl/week and 0.3 g/dl/week, respectively. 
V primerjalni skupini je mediana znašala 29 dni (povečanje koncentracije hemoglobina v prvih 6 tednih je znašalo
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 150 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 150 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
NAME OF THE MEDICINAL PRODUCT MIRCERA 60 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 60 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 40 micrograms PRE-FILLED SYRINGES LABEL 
NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 40 mikrogramov
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/010 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/010
Water for injections 
Odstranjevanje injekcijske brizge
NAME OF THE MEDICINAL PRODUCT MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 50 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta. 
Ena napolnjena injekcijska brizga vsebuje 50 mikrogramov metoksipolietilenglikol epoetina beta.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 100 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 100 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
Cleansing alcohol swabs 
alkoholni zloženci sterilna vata ali gaza
NAME OF THE MEDICINAL PRODUCT MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 40 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
NAME OF THE MEDICINAL PRODUCT MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 100 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
NAME OF THE MEDICINAL PRODUCT MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta 
MIRCERA 30 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 60 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 60 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 60 micrograms PRE-FILLED SYRINGES LABEL 
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 60 mikrogramov
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 40 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 40 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
• A condition called Pure Red Cell Aplasia (PRCA, stopped or reduced production of red blood cells) due to anti-erythropoietin antibodies was observed in some patients treated with erythropoiesis stimulating agents (ESAs), including MIRCERA. 
Pred zdravljenjem z zdravilom MIRCERA · Pri nekaterih bolnikih, zdravljenih z zdravili za spodbujanje eritropoeze (ESA), vključno z zdravilom MIRCERA, so opazili stanje - imenovano čista aplazija rdečih krvnih celic (prekinjeno ali zmanjšano nastajanje rdečih krvnih celic), ki nastane zaradi protiteles proti eritropoetinu.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 30 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 30 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 30 micrograms PRE-FILLED SYRINGES LABEL 
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 30 mikrogramov
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 360 micrograms PRE-FILLED SYRINGES LABEL 
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 360 mikrogramov
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 50 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta 
IME ZDRAVILA IN POT(I) UPORABE MIRCERA 50 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 50 micrograms PRE-FILLED SYRINGES LABEL 
OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 50 mikrogramov
Vascular access thrombosis 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH
EU/1/19/1398/001 (pack of 1 vial) EU/1/19/1398/002 (pack of 5 vials) EU/1/19/1398/003 (pack of 10 vials) 
EU/1/19/1398/001 (pakiranje z 1 vialo) EU/1/19/1398/002 (pakiranje s 5 vialami) EU/1/19/1398/003 (pakiranje z 10 vialami)
Hematologic complete remission (HCR) 
Popolna hematološka remisija (HCR)
Absent Present Not evaluable 
odsotna prisotna ni mogoče vrednotiti
95 % CI for the difference, 2-22 percentage points p<0.001 for noninferiority p = 0.02 for superiority of ATRA+Arsenic trioxide 
95-% IZ za razliko, 2-22 odstotnih točk p < 0,001 za neinferiornost p = 0,02 za superiornost ATRA + arzenov trioksid