FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 250 microgram pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 250 mikrograma napunjena štrcaljka
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
Croatian: MIRCERA 75 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 75 mikrograma metoksi polietilenglikol-epoetina beta* u koncentraciji od 250 mikrograma/ml.
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.
Croatian: MIRCERA 120 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 120 mikrograma metoksi polietilenglikol-epoetina beta* u koncentraciji od 400 mikrograma/ml.
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.
Croatian: MIRCERA 360 mikrograma/0,6 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 360 mikrograma metoksi polietilenglikol-epoetina beta* u koncentraciji od 600 mikrograma/ml.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 mcg/0.3 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 120 mcg/0,3 ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 200 micrograms pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 200 mikrograma napunjena štrcaljka
English: INFORMATION IN BRAILLE mircera 40 mcg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mircera 40 mcg
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.
Croatian: Trajnu razinu hemoglobina iznad 12 g/dl (7,45 mmol/l) treba izbjegavati.
English: INFORMATION IN BRAILLE mircera 30 mcg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mircera 30 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.
Croatian: MIRCERA 40 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 40 mikrograma metoksi polietilenglikol-epoetina beta* u koncentraciji od 133 mikrograma/ml.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 120 micrograms PRE-FILLED SYRINGES LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 120 mikrograma
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mcg/0.3 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 200 mcg/0,3 ml
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta.
Croatian: TVARI Jedna napunjena štrcaljka sadrži 75 mikrograma metoksi polietilenglikol-epoetina beta.
English: INFORMATION IN BRAILLE mircera 60 mcg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mircera 60 mcg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/008
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/008
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 150 microgram pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 150 mikrograma napunjena štrcaljka
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 150 mcg/0.3 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 150 mcg/0,3 ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 30 micrograms pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 30 mikrograma napunjena štrcaljka
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 360 micrograms of methoxy polyethylene glycol-epoetin beta.
Croatian: TVARI Jedna napunjena štrcaljka sadrži 360 mikrograma metoksi polietilenglikol-epoetina beta.
English: INFORMATION IN BRAILLE mircera 100 mcg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mircera 100 mcg
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 360 mcg/0.6 ml injection methoxy polyethylene glycol-epoetin beta
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 360 mcg/0,6 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 60 micrograms pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 60 mikrograma napunjena štrcaljka
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 250 micrograms PRE-FILLED SYRINGES LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 250 mikrograma
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Croatian: MIRCERA 75 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 150 micrograms PRE-FILLED SYRINGES LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 150 mikrograma
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.
Croatian: MIRCERA 100 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 100 mikrograma metoksi polietilenglikol-epoetina beta* u koncentraciji od 333 mikrograma/ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 50 micrograms pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 50 mikrograma napunjena štrcaljka
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 30 micrograms PRE-FILLED SYRINGES LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 30 mikrograma
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 mcg/0.3 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 250 mcg/0,3 ml
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 ESAs, including MIRCERA.
Croatian: U nekih bolesnika liječenih lijekovima za stimulaciju eritropoeze, uključujući i lijek MIRCERA, primijećeno je stanje koje se naziva izolirana aplazija crvene krvne loze (smanjeno ili zaustavljeno stvaranje crvenih krvnih stanica) zbog protutijela na eritropoetin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 100 microgram pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 100 mikrograma napunjena štrcaljka
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.
Croatian: MIRCERA 60 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 60 mikrograma metoksi polietilenglikol-epoetina beta* u koncentraciji od 200 mikrograma/ml.
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Croatian: MIRCERA 360 mikrograma/0,6 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-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
Croatian: MIRCERA 30 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 30 mikrograma metoksi polietilenglikol-epoetina beta* u koncentraciji od 100 mikrograma/ml.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 120 micrograms of methoxy polyethylene glycol-epoetin beta.
Croatian: TVARI Jedna napunjena štrcaljka sadrži 120 mikrograma metoksi polietilenglikol-epoetina beta.
English: Skin and subcutaneous disorders
Croatian: Poremećaji kože i potkožnog tkiva rijetko makulo-papularni osip nepoznato
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/009
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/009
English: Patients currently treated with an ESA:
Croatian: Bolesnici koji se trenutno ne liječe lijekovima za stimulaciju eritropoeze (LSE):
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 200 micrograms PRE-FILLED SYRINGES LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 200 mikrograma
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 40 micrograms pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 40 mikrograma napunjena štrcaljka
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 60 micrograms PRE-FILLED SYRINGES LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 60 mikrograma
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 100 micrograms PRE-FILLED SYRINGES LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 100 mikrograma
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 75 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 75 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mcg/0.3 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 60 mcg/0,3 ml
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 40 micrograms PRE-FILLED SYRINGES LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 40 mikrograma
English: Cases of thrombocytopenia have been reported from post-marketing setting.
Croatian: Nakon stavljanja lijeka u promet prijavljivani su slučajevi trombocitopenije.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 120 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 120 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
English: INFORMATION IN BRAILLE mircera 50 mcg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU mircera 50 mcg
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta.
Croatian: TVARI Jedna napunjena štrcaljka sadrži 200 mikrograma metoksi polietilenglikol-epoetina beta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/023
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/023
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/022
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/022
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 mcg/0.3 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 30 mcg/0,3 ml
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 50 micrograms PRE-FILLED SYRINGES LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 50 mikrograma
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta.
Croatian: TVARI Jedna napunjena štrcaljka sadrži 30 mikrograma metoksi polietilenglikol-epoetina beta.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 50 mcg/0.3 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 50 mcg/0,3 ml
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 250 micrograms of methoxy polyethylene glycol-epoetin beta.
Croatian: TVARI Jedna napunjena štrcaljka sadrži 250 mikrograma metoksi polietilenglikol-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
Croatian: MIRCERA 250 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mcg/0.3 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 40 mcg/0,3 ml
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Croatian: MIRCERA 120 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/018
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/018
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/012
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/012
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Croatian: MIRCERA 150 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mcg/0.3 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 100 mcg/0,3 ml
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/024
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/024
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/013
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/013
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 60 micrograms of methoxy polyethylene glycol-epoetin beta.
Croatian: TVARI Jedna napunjena štrcaljka sadrži 60 mikrograma metoksi polietilenglikol-epoetina beta.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta.
Croatian: TVARI Jedna napunjena štrcaljka sadrži 150 mikrograma metoksi polietilenglikol-epoetina beta.
English: · Never re-use a syringe.
Croatian: • Nikada nemojte istu iglu upotrijebiti dva puta.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 250 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 250 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/017
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/017
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Croatian: MIRCERA 200 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/021
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/021
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 200 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 200 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta.
Croatian: TVARI Jedna napunjena štrcaljka sadrži 40 mikrograma metoksi polietilenglikol-epoetina beta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/020
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/020
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/010
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/010
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/011
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/011
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 100 micrograms of methoxy polyethylene glycol-epoetin beta.
Croatian: TVARI Jedna napunjena štrcaljka sadrži 100 mikrograma metoksi polietilenglikol-epoetina beta.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 150 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 150 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/019
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/019
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 100 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 100 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Croatian: MIRCERA 50 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Croatian: MIRCERA 40 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-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
Croatian: MIRCERA 30 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 60 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Croatian: MIRCERA 60 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-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
Croatian: MIRCERA 100 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 40 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 40 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
English: Peel back the protective film from the plastic tray and remove the needle and the syringe, holding the syringe by the middle of the body without touching the release clips.
Croatian: Odlijepite zaštitnu foliju s plastične plitice te izvadite iglu i štrcaljku.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta.
Croatian: TVARI Jedna napunjena štrcaljka sadrži 50 mikrograma metoksi polietilenglikol-epoetina beta.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 60 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 60 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
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.
Croatian: Ukoliko je mjesečni porast hemoglobina manji od 1,0 g/dl (0,621 mmol/l) doza se smije povećati za otprilike 25% prethodne doze.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 30 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 30 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 50 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 50 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
English: thrombocytopenia thrombosis
Croatian: • tromboza (začepljenje krvne žile krvnim ugruškom)
English: Step5.
Croatian: PRILOG I.
English: 1/1,000 to < 1/100), not known (cannot be estimated from available data).
Croatian: < 1/100), te nepoznato (ne može se procijeniti iz dostupnih podataka).
English: RT-PCR for PML/ RARα
Croatian: RT-PCR za PML/ RARα
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego što primite ovaj lijek jer sadrži Vama važne podatke.
English: Lutomierska 50, 95-200 Pabianice, Poland
Croatian: Lutomierska 50, 95-200 Pabianice, Poljska
English: Conventional Cytogenetics [t(15;17)]
Croatian: standardna citogenetika [t(15;17)]
English: The safety and efficacy of Arsenic trioxide in children aged up to 17 years has not been established.
Croatian: Sigurnost i djelotvornost arsenovog trioksida u djece u dobi do 17 godina nisu ustanovljene.
English: *In the CALGB study C9710, 2 cases of grade ≥3 increased GGT were reported out of the
Croatian: *U ispitivanju CALGB C9710, 2 slučaja stupnja ≥ 3 povećane GGT prijavljena su između 200
English: From a microbiological point of view, the product must be used immediately.
Croatian: S mikrobiološkog stajališta, lijek se mora primijeniti odmah.
English: You may experience convulsions, muscle weakness and confusion.
Croatian: Možete osjetiti konvulzije, slabost u mišićima i smetenost.
English: If you are not sure, show the bottle or pack to your doctor.
Croatian: Ako niste sigurni, pokažite svom liječniku bocu lijeka ili njegovo pakiranje.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Croatian: Obratite se liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.
English: While on treatment with Arsenic trioxide Accord, you may experience some of the following reactions:
Croatian: Dok se liječite lijekom Arsenov trioksid Accord, možete osjetiti neke od sljedećih reakcija:
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX27
Croatian: Farmakoterapijska skupina: Ostali antineoplastici, ATK oznaka: L01XX27 Mehanizam djelovanja
English: Serious adverse reactions were common (1-10%) and not unexpected in the relapsed/refractory population.
Croatian: Ozbiljne nuspojave bile su česte (1-10%) i nisu bile neočekivane za populaciju u fazi relapsa/refraktornoj na liječenje.
English: Personnel should be trained to handle and dilute arsenic trioxide and should wear appropriate protective clothing.
Croatian: Osoblje mora biti obučeno za rukovanje i razrjeđivanje arsenovog trioksida te mora nositi odgovarajuću zaštitnu odjeću.
English: Arsenic trioxide Accord is normally given by a doctor or a nurse.
Croatian: Lijek Arsenov trioksid Accord obično daje liječnik ili medicinska sestra.
English: Your doctor will take the following precautions: - Tests will be performed to check the amount of potassium, magnesium, calcium and creatinine in your blood before your first dose of Arsenic trioxide Accord.
Croatian: Vaš će liječnik poduzeti sljedeće mjere opreza: - Provest će se testovi kako bi se provjerila količina kalija, magnezija, kalcija i kreatinina u Vašoj krvi prije prve doze lijeka Arsenov trioksid Accord.