natgillin/translations-raw huggingface dataset:
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 
30 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 40 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 50 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 60 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 75 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 100 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 120 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 150 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 200 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 250 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki 360 mikrograma/0,6 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
Table 2: Adverse reactions attributed to the treatment with MIRCERA in CKD patients . 
Tablica 2: Nuspojave pripisane liječenju lijekom MIRCERA zabilježene u bolesnika s kroničnom bolesti bubrega.
A slight decrease in platelet counts remaining within the normal range was observed in clinical studies. 
U sklopu kliničkih ispitivanja uočen je neznatan pad broja trombocita, koji je ostao unutar granica normale.
Intravenous route: 
Primjena u venu:
· Do not try to replace the shield on the needle. 
• Nemojte pokušati zamijeniti zaštitni pokrov na igli.
(b) Tabulated list of adverse reactions 
(b) Tablični prikaz nuspojava
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. 
Kako bi se razina hemoglobina povećala na vrijednosti iznad 10 g/dl (6,21 mmol/l), preporučena početna doza za bolesnike koji nisu na dijalizi iznosi 1,2 mikrograma/kg tjelesne težine, primijenjena jedanput mjesečno, kao jedna supkutana injekcija.
Blood and lymphatic system disorders 
Poremećaji krvi i limfnog sustava manje često trombocitopenija*
It can be injected subcutaneously in the abdomen, arm or thigh. 
Može se dati supkutano u trbuh, nadlakticu ili bedro.
A. MANUFACTURER (S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
Subcutaneous route: 
Potkožna primjena:
If the rate of rise in haemoglobin is greater than 2 g/dl (1.24 mmol/l) over a month or if the haemoglobin level is increasing and approaching 12 g/dl (7.45 mmol/l), the dose is to be reduced by approximately 25%. 
Ako je mjesečni porast razine hemoglobina veći od 2 g/dl (1,24 mmol/l) ili ako se povećava i približava razini od 12 g/dl (7,45 mmol/l), dozu treba smanjiti za otprilike 25%.
Alternatively, a starting dose of 0.6 microgram/kg bodyweight may be administered once every two weeks as a single intravenous or subcutaneous injection in patients on dialysis or not on dialysis. 
Alternativno, dijalizirani i nedijalizirani bolesnici mogu primiti početnu dozu od 0,6 mikrograma/kg tjelesne težine, jedanput svaka dva tjedna jednom intravenskom ili supkutanom injekcijom.
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. 
Ako se razina hemoglobina nastavi povećavati, terapiju treba prekinuti dok se razina hemoglobina ne počne smanjivati.
Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment. 
Prijavljene su ozbiljne kožne reakcije, uključujući Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu, povezane s liječenjem epoetinom.
Wipe off the venous port of the hemodialysis as instructed by your healthcare provider 
Obrišite otvor za injekciju na venskoj liniji za hemodijalizu sukladno uputama zdravstvenog radnika.
Dispose of the syringe 
Bacite štrcaljku
MIRCERA has no or negligible influence on the ability to drive and use machines. 
MIRCERA ne utječe na sposobnost upravljanja vozilima i rada sa strojevima ili je taj utjecaj zanemariv.
• If you are a patient with chronic kidney disease and anemia treated with an ESA and are also a cancer patient you should be aware that ESAs, might have a negative impact on your condition. 
• Ako imate kroničnu bolest bubrega i liječite se lijekom za stimulaciju eritropoeze, a bolujete i od karcinoma, budite svjesni da bi lijekovi za stimulaciju eritropoeze mogli imati negativan utjecaj na Vaše stanje.
Throw away used syringes in a puncture-resistant container. 
Upotrijebljene štrcaljke bacite u neprobojni spremnik.
During clinical studies patients had a slight decrease in their platelet blood counts. 
Tijekom kliničkih ispitivanja u bolesnika je primijećen blagi pad broja trombocita.
Slovenská republika Roche Slovensko, s.r.o. 
Česká republika Roche s. r. o.
Injury, poisoning and procedural complications 
Ozljede, trovanja i proceduralne komplikacije manje često tromboza krvožilnog pristupa
· Do not warm up the syringe in any other way. 
• Štrcaljku ne smijete grijati ni na
Only solutions which are clear, colourless to slightly yellowish and free of visible particles must be injected. 
Smiju se primijeniti samo bistre, bezbojne do žućkaste otopine koje ne sadrže vidljive čestice.
If you have developed PRCA, your MIRCERA treatment will be discontinued. 
Ako se u Vas razvila izolirana aplazija crvene krvne loze, liječenje lijekom MIRCERA će se prekinuti.
Grasp the syringe and the rubber tip cap firmly and remove the rubber tip cap from the syringe (bend and pull). 
Čvrsto uhvatite štrcaljku i gumeni zatvarač vrha te skinite gumeni zatvarač vrha sa štrcaljke (savinite i povucite).
Tap the syringe gently to bring any bubbles to the top. 
Lagano prstom kucnite štrcaljku kako bi se mjehurići zraka podigli na vrh.
Remove the pre-filled syringe from the venous port WITHOUT releasing the plunger. 
Izvadite napunjenu štrcaljku iz otvora za injekciju na venskoj liniji, ali pritom NE otpuštajte klip.
Manufacturer Roche Pharma AG Emil-Barell-Strasse 1 
Emil-Barell-Strasse 1
How to use MIRCERA 
Kako primjenjivati lijek MIRCERA
The solution is clear and colourless to slightly yellowish. 
Otopina je bistra i bezbojna do blago žućkasta.
As with other ESAs, cases of thrombosis, including pulmonary embolism, have been reported in the post-marketing setting. 
Kao i kod ostalih lijekova za stimulaciju eritropoeze, nakon puštanja lijeka u promet zabilježeni su slučajevi tromboze, uključujući plućnu emboliju.
Each pack contains 3 pre-filled syringes of 0.3 ml and 3 needles 
Jedno pakiranje sadrži 3 napunjene štrcaljke s 0,3 ml otopine i 3 igle
How to store MIRCERA 
Kako čuvati lijek MIRCERA
· Do not pull on the plunger. 
• Nemojte vući klip.
Dispose of the syringe: · Throw away used syringes in a sharps/ puncture-resistant container. 
• Upotrijebljene štrcaljke bacite u spremnik za oštre predmete/neprobojan spremnik.
Tell your doctor if you are breast-feeding or intend to breast-feed. 
Obavijestite liječnika ako dojite ili namjeravate dojiti.
Nervous system disorders 
Potisnik klipa
Step 4. 
PRILOG III.
In clinical trials, an increased risk of death, serious cardiovascular events including thrombosis or cerebrovascular events including stroke was observed when ESAs were administered to target a haemoglobin of greater than 12 g/dl (7.5 mmol/l) (see section 4.8). 
Koncentracija hemoglobina: U bolesnika s kroničnom bolesti bubrega, koncentracija hemoglobina se treba održavati tako da ne prijeđe gornju granicu ciljne koncentracije hemoglobina preporučene u dijelu 4.2. U kliničkim ispitivanjima primijećen je povećan rizik od smrti, ozbiljnih kardiovaskularnih događaja uključujući trombozu ili cerebrovaskularnih događaja uključujući moždani udar, kada je ciljna razina hemoglobina, postignuta primjenom LSE, bila viša od 12 g/dl (7,5 mmol/l) (vidjeti dio 4.8).
Neutralising anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) has been reported, frequency unknown. 
Prijavljena je izolirana aplazija crvene krvne loze (PRCA) prouzročena neutralizirajućim antieritropoetinskim antitijelima, nepoznate učestalosti.
• The active substance is methoxy polyethylene glycol-epoetin beta. 
• Djelatna tvar je metoksi polietilenglikol-epoetin beta.
Patients currently treated with an ESA can be switched to MIRCERA administered once a month as a single intravenous or subcutaneous injection. 
Bolesnici koji se trenutno liječe lijekovima za stimulaciju eritropoeze (LSE): Bolesnici koji se već liječe s LSE mogu prijeći na lijek MIRCERA i primati je jedanput mjesečno u obliku jedne intravenske ili supkutane injekcije.
Always store the syringe in a refrigerator at a temperature of 2 - 8°C (35.6 - 46.4°F). 
Štrcaljku uvijek čuvajte u hladnjaku na temperaturi od 2 - 8°C.
Attach the needle to the syringe 
Korak 4. Pričvrstite iglu na štrcaljku
METHOD OF ADMINISTRATION Read the package leaflet before use 
NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku
If you miss a dose of MIRCERA administer the missed dose as soon as you remember and talk to your doctor about when to use the next doses. 
Ako propustite dozu lijeka MIRCERA, propuštenu dozu treba primijeniti čim se sjetite.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 75 micrograms 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 75 mikrograma
INFORMATION IN BRAILLE mircera 120 mcg 
16. PODACI NA BRAILLEOVOM PISMU mircera 120 mcg
Using it can lead to too high haemoglobin levels and cause problems with the heart or blood vessels that may be life-threatening. 
• Zdravi ljudi ne smiju uzimati lijek MIRCERA, jer bi to moglo pretjerano povisiti razinu hemoglobina i prouzročiti probleme sa srcem i krvnim žilama koji mogu biti opasni po život.
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. 
U slučaju pojavljivanja znakova i simptoma koji upućuju na te reakcije, potrebno je odmah prekinuti primjenu lijeka Mircera i razmisliti o zamjenskom liječenju.
INFORMATION IN BRAILLE mircera 75 mcg 
16. PODACI NA BRAILLEOVOM PISMU mircera 75 mcg
• 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. 
• 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.
Throw away the needle shield in the punctureresistant container or sharps container. 
Bacite zaštitni pokrov igle u neprobojni spremnik ili spremnik za oštre predmete.
INFORMATION IN BRAILLE mircera 360 mcg 
16. PODACI NA BRAILLEOVOM PISMU mircera 360 mcg
IMPORTANT INFORMATION · Only use MIRCERA pre-filled syringeif you have been prescribed with this · medication. 
• Koristite MIRCERA napunjenu štrcaljku samo ako Vam je propisana.
• hypersensitivity (allergic reaction that can cause unusual wheezing or difficulty in breathing; 
• preosjetljivost (alergijska reakcija koja može uzrokovati neuobičajeno piskanje ili poteškoće pri disanju, oticanje jezika, lica ili ždrijela, ili otekline oko mjesta uboda, osjećaj ošamućenosti,
Each pack contains a pre-filled syringe of 0.6 ml and a needle 
Jedno pakiranje sadrži napunjenu štrcaljku s 0,6 ml otopine i iglu
There have been reports of platelet counts below the normal range (thrombocytopenia) in the post-marketing setting. 
Nakon stavljanja lijeka u promet prijavljeni su slučajevi broja trombocita ispod normalnih vrijednosti (trombocitopenija).
This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V*. 
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 360 micrograms pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 360 mikrograma napunjena štrcaljka
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 30 micrograms 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 30 mikrograma
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. 
MIRCERA 250 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 250 mikrograma metoksi polietilenglikol-epoetina beta* u koncentraciji od 833 mikrograma/ml.
• pulmonary embolism. 
• plućna embolija (krvni ugrušci u plućima)
INFORMATION IN BRAILLE mircera 200 mcg 
16. PODACI NA BRAILLEOVOM PISMU mircera 200 mcg
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 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 200 mikrograma metoksi polietilenglikol-epoetina beta* u koncentraciji od 667 mikrograma/ml.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 360 mcg/0.6 ml 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 360 mcg/0,6 ml
INFORMATION IN BRAILLE mircera 150 mcg 
16. PODACI NA BRAILLEOVOM PISMU mircera 150 mcg
Immediately throw away the needle cap in the sharps/ puncture-resistant container or sharps container. 
Odmah bacite zatvarač igle u spremnik za oštre predmete ili neprobojan spremnik.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 75 micrograms PRE-FILLED SYRINGES LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 75 mikrograma
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 75 mcg/0.3 ml 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 75 mcg/0,3 ml
Each pack contains a pre-filled syringe of 0.3 ml and a needle 
Jedno pakiranje sadrži napunjenu štrcaljku s 0,3 ml otopine i iglu
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 50 micrograms 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 50 mikrograma
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 360 micrograms PRE-FILLED SYRINGES LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 360 mikrograma
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 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 150 mikrograma metoksi polietilenglikol-epoetina beta* u koncentraciji od 500 mikrograma/ml.
INFORMATION IN BRAILLE mircera 250 mcg 
16. PODACI NA BRAILLEOVOM PISMU mircera 250 mcg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 120 micrograms pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 120 mikrograma napunjena štrcaljka
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 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 50 mikrograma metoksi polietilenglikol-epoetina beta* u koncentraciji od 167 mikrograma/ml.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 250 microgram pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 250 mikrograma napunjena štrcaljka
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 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.
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 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.
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 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.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 mcg/0.3 ml 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 120 mcg/0,3 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 200 micrograms pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 200 mikrograma napunjena štrcaljka
INFORMATION IN BRAILLE mircera 40 mcg 
16. PODACI NA BRAILLEOVOM PISMU mircera 40 mcg
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. 
Trajnu razinu hemoglobina iznad 12 g/dl (7,45 mmol/l) treba izbjegavati.
INFORMATION IN BRAILLE mircera 30 mcg 
16. PODACI NA BRAILLEOVOM PISMU mircera 30 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 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.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 120 micrograms PRE-FILLED SYRINGES LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 120 mikrograma
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mcg/0.3 ml 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 200 mcg/0,3 ml
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta. 
TVARI Jedna napunjena štrcaljka sadrži 75 mikrograma metoksi polietilenglikol-epoetina beta.
INFORMATION IN BRAILLE mircera 60 mcg 
16. PODACI NA BRAILLEOVOM PISMU mircera 60 mcg
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/008 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/008
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 150 microgram pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 150 mikrograma napunjena štrcaljka
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 150 mcg/0.3 ml 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 150 mcg/0,3 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 30 micrograms pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 30 mikrograma napunjena štrcaljka
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 360 micrograms of methoxy polyethylene glycol-epoetin beta. 
TVARI Jedna napunjena štrcaljka sadrži 360 mikrograma metoksi polietilenglikol-epoetina beta.
INFORMATION IN BRAILLE mircera 100 mcg 
16. PODACI NA BRAILLEOVOM PISMU mircera 100 mcg
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 360 mcg/0.6 ml injection methoxy polyethylene glycol-epoetin beta 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 360 mcg/0,6 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 60 micrograms pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 60 mikrograma napunjena štrcaljka
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 250 micrograms PRE-FILLED SYRINGES LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 250 mikrograma
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 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 150 micrograms PRE-FILLED SYRINGES LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 150 mikrograma
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 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.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 50 micrograms pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 50 mikrograma napunjena štrcaljka
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 30 micrograms PRE-FILLED SYRINGES LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 30 mikrograma
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 mcg/0.3 ml 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 250 mcg/0,3 ml
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. 
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.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 100 microgram pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 100 mikrograma napunjena štrcaljka
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 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.
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 mikrograma/0,6 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta