natgillin/translations-raw huggingface dataset:
NeoRecormon Multidose contains up to 5.0 mg phenylalanine/vial as an excipient. 
Pomoćne tvari NeoRecormon Multidose sadrži kao pomoćnu tvar do 5,0 g fenilalanina po bočici, što treba uzeti u obzir u bolesnika s teškim oblicima fenilketonurije.
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, should be considered in chronic renal failure patients at risk of shunt thrombosis. 
U bolesnika s kroničnim zatajenjem bubrega kod kojih postoji rizik od tromboze šanta treba razmotriti ranu reviziju šanta i profilaksu tromboze, primjerice primjenom acetilsalicilatne kiseline.
After the injection 
Primjena potkožne injekcije
Be sure that you read, understand and follow the Instructions for Use as well as the package leaflet before injecting NeoRecormon. 
Prije injiciranja lijeka NeoRecormon važno je da pročitate, razumijete i slijedite ove upute za uporabu kao i uputu o lijeku.
For the purpose of ambulatory use, the patient may remove the unreconstituted product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 5 days. 
Ukoliko je potrebno, bolesnik može izvaditi neotopljeni prašak iz hladnjaka i čuvati ga na sobnoj temperaturi (ne višoj od 25°C) ali samo jednom i ne dulje od 5 dana.
NeoRecormon contains phenylalanine and sodium This medicine contains phenylalanine. 
NeoRecormon sadrži fenilalanin i natrij
Solvent: 10 ml ampoule (type I glass). 
Liofilizat: bočica (staklo tip I) s čepom (guma obložena teflonom) Otapalo: i otapala ampula od10 ml (staklo tip I)
5 Place the syringe on a clean, flat surface. 
Položite štrcaljku na čistu i ravnu površinu.
One pre-filled syringe contains either 500, 2000, 3000, 4000, 5000, 6000, 10,000, 20,000 or 30,000 IU (international units) epoetin beta in 0.3 ml or 0.6 ml solution. 
10 000, 20 000 ili 30 000 IU (internacionalnih jedinica) epoetina beta u 0,3 ml ili 0,6 ml otopine.
· Do not flip the carton upside down to remove the syringe. 
Nemojte prevrtati kutiju da biste izvadili štrcaljku.
In clinical trials, an increased risk of death and serious cardiovascular events or cerebrovascular events including stroke was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/dl (7.5 mmol/l). 
U bolesnika s kroničnim zatajenjem bubrega koncentracija hemoglobina tijekom održavanja ne smije premašiti gornju granicu ciljne koncentracije hemoglobina preporučene u dijelu 4.2. U kliničkim ispitivanjima primijećen je povećan rizik od smrti i ozbiljnih kardiovaskularnih događaja ili cerebrovaskularnih događaja uključujući moždani udar, kada su primjenjivani lijekovi za stimulaciju eritropoeze, radi postizanja ciljnog hemoglobina višeg od 12 g/dl (7,5 mmol/l).
· The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 3 days (but not above 25°C). 
● Štrcaljku možete izvaditi iz hladnjaka i ostaviti je na sobnoj temperaturi (ne višoj od 25°C), ali samo jednom i ne dulje od 3 dana.
· Do not recap the injection needle with the cap. · Do not throw away (dispose of) the syringe in your household trash. 
Nemojte odložiti štrcaljku u kućni otpad.
Sodium chloride, 
kalcijev klorid, glicin,
One vial contains 50,000 international units (IU) corresponding to 415 micrograms epoetin beta* (recombinant human erythropoietin). 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 50 000 internacionalnih jedinica (IU) što odgovara 415 mikrograma epoetina beta* (rekombinantnog ljudskog eritropoetina).
Administering the intravenous injection Preparing for injection: follow steps 1 to 8 
Priprema za injiciranje: slijedite korake 1 - 8.
For the purpose of ambulatory use, the patient may remove the medicinal product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 3 days. 
Ukoliko je potrebno, bolesnik može izvaditi lijek iz hladnjaka i čuvati ga na sobnoj temperaturi (ne višoj od 25°C) ali samo jednom i ne dulje od 3 dana.
NeoRecormon 500 IU solution for injection in pre-filled syringe. 
NeoRecormon 500 IU otopina za injekciju u napunjenoj štrcaljki
· The vial can be removed from the refrigerator and left at room temperature for a single period of maximum 5 days (but not above 25°C). 
● Bočicu možete izvaditi iz hladnjaka i ostaviti je na sobnoj temperaturi (ne višoj od 25°C) , ali samo jednom i ne dulje od 5 dana.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. 
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitati uputu o lijeku Za primjenu potkožno i u venu.
ESAs are not indicated for use in this patient population. 
Lijekovi za stimulaciju eritropoeze nisu indicirani za primjenu u toj skupini bolesnika.
Administering the subcutaneous injection 11 Move the safety shield away from the needle in direction to the syringe barrel. 
11. Maknite zaštitni pokrov s igle pomičući ga prema tijelu štrcaljke.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10,441 patients). 
ispitivanja i 13933 bolesnika) dok je za bolesnike s rakom na kemoterapiji omjer rizika ukupnog preživljenja iznosio 1.04 (95% CI: 0,97; 1,11; 38 ispitivanja i 10441 bolesnika).
1 ampoule contains solvent (benzyl alcohol and benzalkonium chloride in water for injections). 
1 ampula sadrži otapalo (benzilni alkohol i benzalkonijev klorid u vodi za injekcije) Lijek sadrži fenilalanin i natrij, a otapalo benzilni alkohol.
Treatment with NeoRecormon is divided into two stages: 
Liječenje lijekom NeoRecormon podijeljeno je na dva stadija: a) Korekcija anemije
L-Isoleucine, 
L-izoleucin, L-treonin,
INFORMATION IN BRAILLE neorecormon 10.000 IU 
neorecormon 10 000 IU
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 500 IU pre-filled syringe 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 500 IU napunjenu štrcaljku
Platelet counts and haemoglobin level should also be monitored at regular intervals in cancer patients. 
Kod bolesnika s rakom treba redovito kontrolirati broj trombocita i razinu hemoglobina.
Name and address of the manufacturer(s) responsible for batch release 
Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet Roche Pharma AG
1 pre-filled syringe (0.3 ml) and 1 needle (30G1/2) 
1 napunjena štrcaljka (0,3 ml) i 1 igla (30G1/2)
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 20,000 IU epoetin beta. 
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 20 000 IU epoetina beta.
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 500 IU pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 500 IU napunjenu štrcaljku
What you need to know before you use NeoRecormon 
Što morate znati prije nego počnete primjenjivati NeoRecormon Kako primjenjivati NeoRecormon Moguće nuspojave
If signs and symptoms suggestive of these reactions appear, NeoRecormon 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 NeoRecormon, 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 NeoRecormon i razmisliti o zamjenskom liječenju.
Table 1: 
PRILOG I.
In addition, transient increases in serum potassium and phosphate levels have been observed in isolated cases (see section 4.4). 
Pored toga, u izoliranim slučajevima zapažen je prolazni porast koncentracija kalija i fosfata u serumu (vidjeti dio
6 Attach the needle to the syringe. 
Pričvrstite iglu na štrcaljku.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 20,000 IU pre-filled syringe 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 20 000 IU napunjenu štrcaljku
Patients in an autologous blood predonation programme Patients in an autologous blood predonation programme have been reported to show a slightly higher frequency of thromboembolic events. 
U bolesnika u programu predonacije autologne krvi prijavljena je nešto veća učestalost tromboembolijskih događaja, međutim nije bilo moguće ustanoviti uzročnu povezanost s terapijom lijekom NeoRecormon.
9 Clean the skin above the injection port with an alcohol swab and let dry. 
Kožu iznad katetera očistite tupferom natopljenim alkoholom i pustite da se sama osuši.
This may be given as one injection per week, or in divided doses as 3 to 7 injections per week. 
Doza se može dati kao jedna injekcija tjedno ili rasporediti na 3 do 7 injekcija tijekom tjedna.
6 pre-filled syringes (0.3 ml) and 6 needles (30G1/2) 
6 napunjenih štrcaljki (0,3 ml) i 6 igala (30G1/2)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 2000 IU pre-filled syringe 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 2000 IU napunjenu štrcaljku
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 6000 IU pre-filled syringe 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 6000 IU napunjenu štrcaljku
Do not increase the dose your doctor has given you. 
Ako injektirate preveliku dozu lijeka NeoRecormon Nemojte povećavati dozu koju Vam je propisao liječnik.
MARKETING AUTHORISATION NUMBER EU/1/97/031/019 
EU/1/97/031/019
Thromboembolic event 
Poremećaji krvi i limfnog sustava Tromboembolijski događaj
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 5000 IU epoetin beta. 
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 5000 IU epoetina beta.
INFORMATION IN BRAILLE neorecormon 50,000 IU 
neorecormon 50 000 IU
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 6000 IU pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 6000 IU napunjenu štrcaljku
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 20,000 IU pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 20 000 IU napunjenu štrcaljku
INFORMATION IN BRAILLE neorecormon 30.000 IU 
neorecormon 30 000 IU
INFORMATION IN BRAILLE neorecormon 5000 IU 
neorecormon 5000 IU
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 4000 IU pre-filled syringe 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 4000 IU napunjenu štrcaljku
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 50.000 IUVIAL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICE ZA 50 000 IU BOČICU
INFORMATION IN BRAILLE neorecormon 6000 IU 
neorecormon 6000 IU
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 6000 IU epoetin beta. 
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 6000 IU epoetina beta.
Female patients 
Žene
- Subcutaneous administration: - The initial dosage is 3 x 20 IU/kg body weight per week. 
- Supkutana primjena: Početna doza iznosi 3 x 20 IU/kg tjel. mase tjedno.
He or she may raise or lower your dose, or interrupt your treatment according to the test results. 
Obzirom na rezultate krvnih pretraga, liječnik Vam može povećati ili smanjiti dozu ili prekinuti liječenje lijekom NeoRecormon.
NAME OF THE MEDICINAL PRODUCT NeoRecormon Multidose 50,000 IU lyophilisate and solvent for solution for injection 
NeoRecormon Multidose 50 000 IU liofilizat i otapalo za otopinu za injekciju
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 30,000 IU pre-filled syringe 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 30 000 IU napunjenu štrcaljku
· Keep the vials in the outer carton in order to protect from light. 
● Bočice čuvajte u vanjskom pakiranju radi zaštite od svjetlosti.
One ml of reconstituted solution contains 5000 IU epoetin beta. 
Jedan mililitar pripremljene otopine sadrži 5000 IU epoetina beta.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 2000 IU epoetin beta. 
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 2000 IU epoetina beta.
· Do not handle the syringe by holding the plunger or needle cap. 
Nemojte štrcaljku držati za klip ili zatvarač igle.
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 2000 IU pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 2000 IU napunjenu štrcaljku
1 pre-filled syringe (0.3 ml) and 1 needle (27G1/2) 
1 napunjena štrcaljka (0,3 ml) i 1 igla (27G1/2)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 10,000 IU pre-filled syringe 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 10 000 IU napunjenu štrcaljku
INFORMATION IN BRAILLE neorecormon 4000 IU 
neorecormon 4000 IU
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 30,000 IU pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 30 000 IU napunjenu štrcaljku
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 5000 IU pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 5000 IU napunjenu štrcaljku
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 3000 IU pre-filled syringe 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 3000 IU napunjenu štrcaljku
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 10,000 IU pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 10 000 IU napunjenu štrcaljku
(5) Attach the device to the vial until the snap lock clicks home. (6) Put the green needle on the syringe contained in the package and remove the needle cover. 
(6) Stavite zelenu iglu na štrcaljku iz pakiranja i uklonite pokrov igle.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 30,000 IU epoetin beta. 
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 30 000 IU epoetina beta.
Form a skin fold by pinching the skin between thumb and forefinger. 
Palcem i kažiprstom naberite kožu.
NeoRecormon 30,000 IU solution for injection in pre-filled syringe 
NeoRecormon 20 000 IU otopina za injekciju u napunjenoj štrcaljki
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5000 IU/1 ml 
5000 IU/1 ml
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 4000 IU pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 4000 IU napunjenu štrcaljku
4 pre-filled syringes (0.6 ml) and 4 needles (27G1/2) 
4 napunjene štrcaljke (0,6 ml) i 4 igle (27G1/2)
15 Insert the needle into the injection port (follow the instruction of the injection port provider) ·Do not hold or push on the plunger while inserting needle. 
15. Uvedite iglu u kateter (slijedite upute dobavljača katetera)
Keep the pre-filled syringe in the outer carton, in order to protect from light. 
Napunjenu štrcaljku čuvajte u vanjskom pakiranju radi zaštite od svjetlosti.
Remove the needle and syringe from the injection port at the same angle as inserted. 
Izvucite iglu i štrcaljku iz katetera pod istim kutom pod kojim ste ih uveli.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 500 IU epoetin beta. 
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 500 IU epoetina beta.
NAME OF THE MEDICINAL PRODUCT NeoRecormon 20,000 IU solution for injection in pre-filled syringe Epoetin beta 
NeoRecormon 20 000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
PHARMACEUTICAL FORM AND CONTENTS Lyophilisate and solvent for solution for injection 1 vial with lyophilisate (50,000 IU) for solution for injection, 1 ampoule with preserved solvent (10 ml), 1 reconstitution and withdrawal device, 1 disposable syringe (10 ml), 1 needle (21G2) 
Liofilizat i otapalo za otopinu za injekciju 1 bočica s liofilizatom (50 000 IU) za otopinu za injekciju, 1 ampula s otapalom s konzervansom
Keep the pre-filled syringe in the outer carton, in order to protect from light 
Napunjenu štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 10,000 IU epoetin beta. 
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 10 000 IU epoetina beta.
1 pre-filled syringe (0.6 ml) and 1 needle (27G1/2) 
1 napunjena štrcaljka (0,6 ml) i 1 igla (27G1/2)
NAME OF THE MEDICINAL PRODUCT NeoRecormon 5000 IU solution for injection in pre-filled syringe Epoetin beta 
NeoRecormon 5000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/046 
EU/1/97/031/046
NAME OF THE MEDICINAL PRODUCT NeoRecormon 500 IU solution for injection in pre-filled syringe Epoetin beta 
NeoRecormon 500 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to NeoRecormon (see section 4.8). 
Stoga se bolesnicima kod kojih postoji sumnja ili kod kojih je potvrđeno da imaju neutralizirajuća antitijela na eritropoetin, ne smije uvoditi terapija lijekom NeoRecormon
Only one vial of NeoRecormon Multidose must be in use (i.e. reconstituted) at any one time. 
Istovremeno u primjeni (tj. pripremljena) treba biti samo jedna bočica lijeka NeoRecormon Multidose.
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 3000 IU pre-filled syringe 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 3000 IU napunjenu štrcaljku
Storage Instructions 
Prijavljivanje nuspojava
In this case you should not be switched to NeoRecormon. 
U tom slučaju ne biste smjeli biti prebačeni na liječenje lijekom
Always follow aseptic techniques. 
Čuvati na 2°C-8°C Uvijek se pridržavajte aseptičkih postupaka
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/035 
EU/1/97/031/035
The solution is administered subcutaneously at a dose of 3 x 250 IU/kg b.w. 
Otopina se daje supkutano u dozi od 3 x 250 IU/kg tjel. mase tjedno.
Medicinal product contains phenylalanine and sodium, see leaflet for further information 
Lijek sadrži fenilalanin i natrij.
6 pre-filled syringes (0.3 ml) and 6 needles (27G1/2) 
6 napunjenih štrcaljki (0,3 ml) i 6 igala (27G1/2)
NAME OF THE MEDICINAL PRODUCT NeoRecormon 4000 IU solution for injection in pre-filled syringe Epoetin beta 
NeoRecormon 4000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
INFORMATION IN BRAILLE neorecormon 3000 IU 
neorecormon 3000 IU
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 3000 IU epoetin beta. 
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 3000 IU epoetina beta.
NAME OF THE MEDICINAL PRODUCT NeoRecormon 30,000 IU solution for injection in pre-filled syringe Epoetin beta 
NeoRecormon 30 000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
NeoRecormon 2000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 2000 international units (IU) corresponding to 16.6 micrograms epoetin beta* (recombinant human erythropoietin). 
Jedna napunjena štrcaljka s 0,3 ml otopine za injekciju sadrži 2000 internacionalnih jedinica (IU) što odgovara 16,6 mikrograma epoetina beta* (rekombinantnog ljudskog eritropoetina).
NAME OF THE MEDICINAL PRODUCT NeoRecormon 2000 IU solution for injection in pre-filled syringe Epoetin beta 
NeoRecormon 2000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
If you do not respond adequately to NeoRecormon, your doctor will check your dose and will inform you if you need to change doses. 
Ako ne budete odgovarali na lijek NeoRecormon na odgovarajući način, Vaš liječnik će provjeriti
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 4000 IU epoetin beta. 
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 4000 IU epoetina beta.
6 pre-filled syringes (0.6 ml) and 6 needles (27G1/2) 
6 napunjenih štrcaljki (0,6 ml) i 6 igala (27G1/2)
NAME OF THE MEDICINAL PRODUCT NeoRecormon 10,000 IU solution for injection in pre-filled syringe Epoetin beta 
NeoRecormon 10 000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
· Do not hold the plunger while you remove the needle cap. · Do not touch the needle after removing the needle cap. · Do not re-cap the needle. 
Nemojte dodirivati iglu nakon što skinete zatvarač igle.
NeoRecormon 20,000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.6 ml solution for injection contains 20,000 international units (IU) corresponding to 166 micrograms epoetin beta* (recombinant human erythropoietin). 
Jedna napunjena štrcaljka s 0,6 ml otopine za injekciju sadrži 20 000 internacionalnih jedinica (IU) što odgovara 166 mikrograma epoetina beta* (rekombinantnog ljudskog eritropoetina).
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/034 
EU/1/97/031/034
Treatment of symptomatic chemotherapy-induced anaemia in cancer patients NeoRecormon should be administered by the subcutaneous route to patients with anaemia (e.g. 
Liječenje simptomatske anemije uzrokovane kemoterapijom u bolesnika s rakom
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/033 
EU/1/97/031/033
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 
Meta-analiza podataka o ukupnom preživljenju dala je procjenu omjera rizika od 1,06 u korist kontrolnih skupina (95% CI: 1,00; 1,12; 53
· The other ingredients are: urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, and L-Phenylalanine and water for injections. 
Drugi sastojci su: urea, natrijev klorid, polisorbat 20, natrijev dihidrogenfosfat, natrijev hidrogenfosfat, kalcijev klorid, glicin, L-leucin, L-izoleucin, L-treonin, L- glutamatna kiselina, L-fenilalanin i voda za injekcije.
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/032 
EU/1/97/031/032
If you are donating your own blood before surgery, your doctor will need to: · check that you are capable of giving blood, especially if you weigh less than 50 kg · check that you have a sufficient level of red blood cells (haemoglobin of at least 11 g/dL) · make sure that only 12 % of your blood will be donated at once. 
● provjeriti jeste li u stanju dati krv, osobito ako Vam je tjelesna masa manja od 50 kg
(content of accompanying solvent ampoule). 
(doza održavanja).
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/043 
EU/1/97/031/043
A sustained haemoglobin level of greater than 12 g/dl (7.5 mmol/l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/dl (7.5 mmol/l) are observed are described below. 
Treba izbjegavati trajnu razinu hemoglobina iznad 12 g/dl (7,5 mmol/l).
NAME OF THE MEDICINAL PRODUCT NeoRecormon 6000 IU solution for injection in pre-filled syringe Epoetin beta 
NeoRecormon 6000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/038 
EU/1/97/031/038
NeoRecormon 6000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 6000 international units (IU) corresponding to 49.8 micrograms epoetin beta* (recombinant human erythropoietin). 
Jedna napunjena štrcaljka s 0,3 ml otopine za injekciju sadrži 6000 internacionalnih jedinica (IU) što odgovara 49,8 mikrograma epoetina beta* (rekombinantnog ljudskog eritropoetina).
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/036 
EU/1/97/031/036
INFORMATION IN BRAILLE neorecormon 500 IU 
NeoRecormon 500 IU
Vascular disorders 
Organski sustav
NAME OF THE MEDICINAL PRODUCT NeoRecormon 3000 IU solution for injection in pre-filled syringe Epoetin beta 
NeoRecormon 3000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/042 
EU/1/97/031/042
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/037 
EU/1/97/031/037
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/045 
EU/1/97/031/045