FrancophonIA/ELRC3.0 huggingface dataset:
English: • 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.
Slovenian: · 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.
English: INFORMATION IN BRAILLE mircera 40 mcg
Slovenian: PODATKI V BRAILLOVI PISAVI mircera 40 mcg
English: INFORMATION IN BRAILLE mircera 60 mcg
Slovenian: PODATKI V BRAILLOVI PISAVI mircera 60 mcg
English: Each pack contains a pre-filled syringe of 0.6 ml and a needle
Slovenian: Pakiranje vsebuje napolnjeno injekcijsko brizgo po 0,6 ml in iglo
English: 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.
Slovenian: Smernice za ustrezno prilagajanje odmerkov, ko koncentracija hemoglobina preseže 12 g/dl (7,45 mmol/l), so opisane spodaj.
English: 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.
Slovenian: 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.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 30 micrograms
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 30 mikrogramov
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 mcg/0.3 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 250 µg/0,3 ml
English: 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).
Slovenian: porod ali postnatalni razvoj; reverzibilno zmanjšanje plodove teže (glejte poglavje 5.3) pa nakazuje povezavo s to skupino zdravil.
English: INFORMATION IN BRAILLE mircera 100 mcg
Slovenian: PODATKI V BRAILLOVI PISAVI mircera 100 mcg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 250 microgram pre-filled syringe
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 250 mikrogramov napolnjena injekcijska brizga
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 75 mikrogramov metoksipolietilenglikol epoetina beta.
English: 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.
Slovenian: 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.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/008
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/008
English: 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.
Slovenian: 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.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 200 micrograms pre-filled syringe
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 200 mikrogramov napolnjena injekcijska brizga
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 150 microgram pre-filled syringe
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 150 mikrogramov napolnjena injekcijska brizga
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 150 mcg/0.3 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 150 µg/0,3 ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 75 micrograms
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 75 mikrogramov
English: How to store MIRCERA
Slovenian: Shranjevanje zdravila MIRCERA
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 360 micrograms of methoxy polyethylene glycol-epoetin beta.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 360 mikrogramov metoksipolietilenglikol epoetina beta.
English: INFORMATION IN BRAILLE mircera 50 mcg
Slovenian: PODATKI V BRAILLOVI PISAVI mircera 50 mcg
English: 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.
Slovenian: 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.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mcg/0.3 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 200 µg/0,3 ml
English: Skin and subcutaneous disorders
Slovenian: Bolezni kože in podkožja redki makulopapulozni izpuščaj neznana
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 30 micrograms pre-filled syringe
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 30 mikrogramov napolnjena injekcijska brizga
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/009
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/009
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 100 microgram pre-filled syringe
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 100 mikrogramov napolnjena injekcijska brizga
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 50 micrograms pre-filled syringe
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 50 mikrogramov napolnjena injekcijska brizga
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 120 micrograms of methoxy polyethylene glycol-epoetin beta.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 120 mikrogramov metoksipolietilenglikol epoetina beta.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 360 mcg/0.6 ml injection methoxy polyethylene glycol-epoetin beta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE MIRCERA 360 mg/0,6 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Slovenian: MIRCERA 75 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
English: Do not freeze
Slovenian: Ne stresajte
English: Step 6.
Slovenian: Korak 6: Injiciranje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 40 micrograms pre-filled syringe
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 40 mikrogramov napolnjena injekcijska brizga
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Slovenian: MIRCERA 360 mikrogramov/0,6 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
English: 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
Slovenian: 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.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 mcg/0.3 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 30 µg/0,3 ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 60 micrograms pre-filled syringe
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 60 mikrogramov napolnjena injekcijska brizga
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 50 micrograms
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 50 mikrogramov
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Only one dose should be administered per syringe.
Slovenian: Iz ene napolnjene injekcijske brizge lahko odvzamemo le en odmerek.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 120 micrograms PRE-FILLED SYRINGES LABEL
Slovenian: OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 120 mikrogramov
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mcg/0.3 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 100 µg/0,3 ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 75 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE MIRCERA 75 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 200 mikrogramov metoksipolietilenglikol epoetina beta.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mcg/0.3 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 60 µg/0,3 ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 120 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE MIRCERA 120 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Napolnjena injekcijska brizga je pripravljena za uporabo.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/023
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/023
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 150 mikrogramov metoksipolietilenglikol epoetina beta.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 150 micrograms PRE-FILLED SYRINGES LABEL
Slovenian: OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 150 mikrogramov
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 250 micrograms of methoxy polyethylene glycol-epoetin beta.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 250 mikrogramov metoksipolietilenglikol epoetina beta.
English: Each pack contains a pre-filled syringe of 0.3 ml and a needle
Slovenian: Eno pakiranje vsebuje napolnjeno injekcijsko brizgo po 0,3 ml in iglo
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/018
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/018
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 50 mcg/0.3 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 50 µg/0,3 ml
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/012
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/012
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/024
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/024
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/017
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/017
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 30 mikrogramov metoksipolietilenglikol epoetina beta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/022
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/022
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Slovenian: MIRCERA 150 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 60 micrograms of methoxy polyethylene glycol-epoetin beta.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 60 mikrogramov metoksipolietilenglikol epoetina beta.
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 250 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Slovenian: MIRCERA 250 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mcg/0.3 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 40 µg/0,3 ml
English: To remove air bubbles from the prefilled syringe, hold the syringe with the needle pointing up.
Slovenian: Držite injekcijsko brizgo z iglo obrnjeno navzgor, da boste odstranili zračne mehurčke iz injekcijske brizge.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 40 mikrogramov metoksipolietilenglikol epoetina beta.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 100 micrograms of methoxy polyethylene glycol-epoetin beta.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 100 mikrogramov metoksipolietilenglikol epoetina beta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/013
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/013
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 75 micrograms PRE-FILLED SYRINGES LABEL
Slovenian: OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 75 mikrogramov
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 250 micrograms PRE-FILLED SYRINGES LABEL
Slovenian: OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 250 mikrogramov
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/011
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/011
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Slovenian: MIRCERA 120 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 200 micrograms PRE-FILLED SYRINGES LABEL
Slovenian: OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 200 mikrogramov
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 250 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE MIRCERA 250 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/020
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/020
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 100 micrograms PRE-FILLED SYRINGES LABEL
Slovenian: OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 100 mikrogramov
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/019
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/019
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 200 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE MIRCERA 200 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/021
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/021
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Slovenian: MIRCERA 200 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
English: 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.
Slovenian: V primerjalni skupini je mediana znašala 29 dni (povečanje koncentracije hemoglobina v prvih 6 tednih je znašalo
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 150 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE MIRCERA 150 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 60 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Slovenian: MIRCERA 60 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 40 micrograms PRE-FILLED SYRINGES LABEL
Slovenian: NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 40 mikrogramov
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/010
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/400/010
English: Water for injections
Slovenian: Odstranjevanje injekcijske brizge
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Slovenian: MIRCERA 50 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 50 mikrogramov metoksipolietilenglikol epoetina beta.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 100 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE MIRCERA 100 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
English: Cleansing alcohol swabs
Slovenian: alkoholni zloženci sterilna vata ali gaza
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Slovenian: MIRCERA 40 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Slovenian: MIRCERA 100 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi metoksipolietilenglikol epoetin beta
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 30 micrograms/0.3 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 metoksipolietilenglikol epoetin beta
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 60 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE MIRCERA 60 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 60 micrograms PRE-FILLED SYRINGES LABEL
Slovenian: OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 60 mikrogramov
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 40 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE MIRCERA 40 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
English: • 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.
Slovenian: 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.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 30 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE MIRCERA 30 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 30 micrograms PRE-FILLED SYRINGES LABEL
Slovenian: OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 30 mikrogramov
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 360 micrograms PRE-FILLED SYRINGES LABEL
Slovenian: OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 360 mikrogramov
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 50 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE MIRCERA 50 mg/0,3 ml injekcija metoksipolietilenglikol epoetin beta s.c./i.v.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 50 micrograms PRE-FILLED SYRINGES LABEL
Slovenian: OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO 50 mikrogramov
English: Vascular access thrombosis
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH
English: 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)
Slovenian: 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)
English: Hematologic complete remission (HCR)
Slovenian: Popolna hematološka remisija (HCR)
English: Absent Present Not evaluable
Slovenian: odsotna prisotna ni mogoče vrednotiti
English: Lutomierska 50, 95-200 Pabianice, Poland
Slovenian: Lutomierska 50, 95-200 Pabianice, Poljska
English: 95 % CI for the difference, 2-22 percentage points p<0.001 for noninferiority p = 0.02 for superiority of ATRA+Arsenic trioxide
Slovenian: 95-% IZ za razliko, 2-22 odstotnih točk p < 0,001 za neinferiornost p = 0,02 za superiornost ATRA + arzenov trioksid
English: The results are summarised in the table 4 below.
Slovenian: Rezultati so povzeti v preglednici 4 spodaj.
English: Conventional Cytogenetics [t(15;17)]
Slovenian: Navadna citogenetika [t(15;17)]
English: The daily dose can be escalated back to 100% of the original dose if no prolongation occurs.
Slovenian: Dnevni odmerek lahko zvečate na 100 % prvotnega odmerka, če ne pride do podaljšanja.