natgillin/translations-raw huggingface dataset:
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
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 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.
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 120 micrograms of methoxy polyethylene glycol-epoetin beta.
TVARI Jedna napunjena štrcaljka sadrži 120 mikrograma metoksi polietilenglikol-epoetina beta.
Skin and subcutaneous disorders
Poremećaji kože i potkožnog tkiva rijetko makulo-papularni osip nepoznato
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/009
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/009
Patients currently treated with an ESA:
Bolesnici koji se trenutno ne liječe lijekovima za stimulaciju eritropoeze (LSE):
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 200 micrograms PRE-FILLED SYRINGES LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 200 mikrograma
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 40 micrograms pre-filled syringe
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 40 mikrograma napunjena štrcaljka
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 60 micrograms PRE-FILLED SYRINGES LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 60 mikrograma
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 100 micrograms PRE-FILLED SYRINGES LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 100 mikrograma
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 75 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 75 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mcg/0.3 ml
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 60 mcg/0,3 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 40 micrograms PRE-FILLED SYRINGES LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 40 mikrograma
Cases of thrombocytopenia have been reported from post-marketing setting.
Nakon stavljanja lijeka u promet prijavljivani su slučajevi trombocitopenije.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 120 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 120 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
INFORMATION IN BRAILLE mircera 50 mcg
16. PODACI NA BRAILLEOVOM PISMU mircera 50 mcg
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta.
TVARI Jedna napunjena štrcaljka sadrži 200 mikrograma metoksi polietilenglikol-epoetina beta.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/023
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/023
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/022
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/022
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 mcg/0.3 ml
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 30 mcg/0,3 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 50 micrograms PRE-FILLED SYRINGES LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU 50 mikrograma
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta.
TVARI Jedna napunjena štrcaljka sadrži 30 mikrograma metoksi polietilenglikol-epoetina beta.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 50 mcg/0.3 ml
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 50 mcg/0,3 ml
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 250 micrograms of methoxy polyethylene glycol-epoetin beta.
TVARI Jedna napunjena štrcaljka sadrži 250 mikrograma metoksi polietilenglikol-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 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mcg/0.3 ml
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 40 mcg/0,3 ml
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 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/018
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/018
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/012
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/012
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 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mcg/0.3 ml
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 100 mcg/0,3 ml
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/024
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/024
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/013
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/013
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 60 micrograms of methoxy polyethylene glycol-epoetin beta.
TVARI Jedna napunjena štrcaljka sadrži 60 mikrograma metoksi polietilenglikol-epoetina beta.
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta.
TVARI Jedna napunjena štrcaljka sadrži 150 mikrograma metoksi polietilenglikol-epoetina beta.
· Never re-use a syringe.
• Nikada nemojte istu iglu upotrijebiti dva puta.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 250 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 250 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/017
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/017
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 mikrograma/0,3 ml otopina za injekciju u napunjenoj štrcaljki metoksi polietilenglikol-epoetin beta
MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/021
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/400/021
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 200 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MIRCERA 200 mcg/0,3 ml injekcija metoksi polietilenglikol-epoetin beta s.c./i.v.