FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Croatian: 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).
English: · 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).
Croatian: ● 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.
English: · Do not recap the injection needle with the cap. · Do not throw away (dispose of) the syringe in your household trash.
Croatian: Nemojte odložiti štrcaljku u kućni otpad.
English: Sodium chloride,
Croatian: kalcijev klorid, glicin,
English: One vial contains 50,000 international units (IU) corresponding to 415 micrograms epoetin beta* (recombinant human erythropoietin).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 50 000 internacionalnih jedinica (IU) što odgovara 415 mikrograma epoetina beta* (rekombinantnog ljudskog eritropoetina).
English: Administering the intravenous injection Preparing for injection: follow steps 1 to 8
Croatian: Priprema za injiciranje: slijedite korake 1 - 8.
English: 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.
Croatian: 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.
English: NeoRecormon 500 IU solution for injection in pre-filled syringe.
Croatian: NeoRecormon 500 IU otopina za injekciju u napunjenoj štrcaljki
English: · 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).
Croatian: ● 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.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitati uputu o lijeku Za primjenu potkožno i u venu.
English: ESAs are not indicated for use in this patient population.
Croatian: Lijekovi za stimulaciju eritropoeze nisu indicirani za primjenu u toj skupini bolesnika.
English: Administering the subcutaneous injection 11 Move the safety shield away from the needle in direction to the syringe barrel.
Croatian: 11. Maknite zaštitni pokrov s igle pomičući ga prema tijelu štrcaljke.
English: 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).
Croatian: 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).
English: 1 ampoule contains solvent (benzyl alcohol and benzalkonium chloride in water for injections).
Croatian: 1 ampula sadrži otapalo (benzilni alkohol i benzalkonijev klorid u vodi za injekcije) Lijek sadrži fenilalanin i natrij, a otapalo benzilni alkohol.
English: Treatment with NeoRecormon is divided into two stages:
Croatian: Liječenje lijekom NeoRecormon podijeljeno je na dva stadija: a) Korekcija anemije
English: L-Isoleucine,
Croatian: L-izoleucin, L-treonin,
English: INFORMATION IN BRAILLE neorecormon 10.000 IU
Croatian: neorecormon 10 000 IU
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 500 IU pre-filled syringe
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 500 IU napunjenu štrcaljku
English: Platelet counts and haemoglobin level should also be monitored at regular intervals in cancer patients.
Croatian: Kod bolesnika s rakom treba redovito kontrolirati broj trombocita i razinu hemoglobina.
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet Roche Pharma AG
English: 1 pre-filled syringe (0.3 ml) and 1 needle (30G1/2)
Croatian: 1 napunjena štrcaljka (0,3 ml) i 1 igla (30G1/2)
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 20,000 IU epoetin beta.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 20 000 IU epoetina beta.
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 500 IU pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 500 IU napunjenu štrcaljku
English: What you need to know before you use NeoRecormon
Croatian: Što morate znati prije nego počnete primjenjivati NeoRecormon Kako primjenjivati NeoRecormon Moguće nuspojave
English: 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.
Croatian: U slučaju pojavljivanja znakova i simptoma koji upućuju na te reakcije, potrebno je odmah prekinuti primjenu lijeka NeoRecormon i razmisliti o zamjenskom liječenju.
English: Table 1:
Croatian: PRILOG I.
English: In addition, transient increases in serum potassium and phosphate levels have been observed in isolated cases (see section 4.4).
Croatian: Pored toga, u izoliranim slučajevima zapažen je prolazni porast koncentracija kalija i fosfata u serumu (vidjeti dio
English: 6 Attach the needle to the syringe.
Croatian: Pričvrstite iglu na štrcaljku.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 20,000 IU pre-filled syringe
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 20 000 IU napunjenu štrcaljku
English: 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.
Croatian: 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.
English: 9 Clean the skin above the injection port with an alcohol swab and let dry.
Croatian: Kožu iznad katetera očistite tupferom natopljenim alkoholom i pustite da se sama osuši.
English: This may be given as one injection per week, or in divided doses as 3 to 7 injections per week.
Croatian: Doza se može dati kao jedna injekcija tjedno ili rasporediti na 3 do 7 injekcija tijekom tjedna.
English: 6 pre-filled syringes (0.3 ml) and 6 needles (30G1/2)
Croatian: 6 napunjenih štrcaljki (0,3 ml) i 6 igala (30G1/2)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 2000 IU pre-filled syringe
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 2000 IU napunjenu štrcaljku
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 6000 IU pre-filled syringe
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 6000 IU napunjenu štrcaljku
English: Do not increase the dose your doctor has given you.
Croatian: Ako injektirate preveliku dozu lijeka NeoRecormon Nemojte povećavati dozu koju Vam je propisao liječnik.
English: MARKETING AUTHORISATION NUMBER EU/1/97/031/019
Croatian: EU/1/97/031/019
English: Thromboembolic event
Croatian: Poremećaji krvi i limfnog sustava Tromboembolijski događaj
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 5000 IU epoetin beta.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 5000 IU epoetina beta.
English: INFORMATION IN BRAILLE neorecormon 50,000 IU
Croatian: neorecormon 50 000 IU
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 6000 IU pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 6000 IU napunjenu štrcaljku
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 20,000 IU pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 20 000 IU napunjenu štrcaljku
English: INFORMATION IN BRAILLE neorecormon 30.000 IU
Croatian: neorecormon 30 000 IU
English: INFORMATION IN BRAILLE neorecormon 5000 IU
Croatian: neorecormon 5000 IU
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 4000 IU pre-filled syringe
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 4000 IU napunjenu štrcaljku
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 50.000 IUVIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICE ZA 50 000 IU BOČICU
English: INFORMATION IN BRAILLE neorecormon 6000 IU
Croatian: neorecormon 6000 IU
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 6000 IU epoetin beta.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 6000 IU epoetina beta.
English: Female patients
Croatian: Žene
English: - Subcutaneous administration: - The initial dosage is 3 x 20 IU/kg body weight per week.
Croatian: - Supkutana primjena: Početna doza iznosi 3 x 20 IU/kg tjel. mase tjedno.
English: He or she may raise or lower your dose, or interrupt your treatment according to the test results.
Croatian: Obzirom na rezultate krvnih pretraga, liječnik Vam može povećati ili smanjiti dozu ili prekinuti liječenje lijekom NeoRecormon.
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon Multidose 50,000 IU lyophilisate and solvent for solution for injection
Croatian: NeoRecormon Multidose 50 000 IU liofilizat i otapalo za otopinu za injekciju
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 30,000 IU pre-filled syringe
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 30 000 IU napunjenu štrcaljku
English: · Keep the vials in the outer carton in order to protect from light.
Croatian: ● Bočice čuvajte u vanjskom pakiranju radi zaštite od svjetlosti.
English: One ml of reconstituted solution contains 5000 IU epoetin beta.
Croatian: Jedan mililitar pripremljene otopine sadrži 5000 IU epoetina beta.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 2000 IU epoetin beta.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 2000 IU epoetina beta.
English: · Do not handle the syringe by holding the plunger or needle cap.
Croatian: Nemojte štrcaljku držati za klip ili zatvarač igle.
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 2000 IU pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 2000 IU napunjenu štrcaljku
English: 1 pre-filled syringe (0.3 ml) and 1 needle (27G1/2)
Croatian: 1 napunjena štrcaljka (0,3 ml) i 1 igla (27G1/2)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 10,000 IU pre-filled syringe
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 10 000 IU napunjenu štrcaljku
English: INFORMATION IN BRAILLE neorecormon 4000 IU
Croatian: neorecormon 4000 IU
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 30,000 IU pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 30 000 IU napunjenu štrcaljku
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 5000 IU pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 5000 IU napunjenu štrcaljku
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 3000 IU pre-filled syringe
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 3000 IU napunjenu štrcaljku
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 10,000 IU pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 10 000 IU napunjenu štrcaljku
English: (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.
Croatian: (6) Stavite zelenu iglu na štrcaljku iz pakiranja i uklonite pokrov igle.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 30,000 IU epoetin beta.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 30 000 IU epoetina beta.
English: Form a skin fold by pinching the skin between thumb and forefinger.
Croatian: Palcem i kažiprstom naberite kožu.
English: NeoRecormon 30,000 IU solution for injection in pre-filled syringe
Croatian: NeoRecormon 20 000 IU otopina za injekciju u napunjenoj štrcaljki
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5000 IU/1 ml
Croatian: 5000 IU/1 ml
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 4000 IU pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 4000 IU napunjenu štrcaljku
English: 4 pre-filled syringes (0.6 ml) and 4 needles (27G1/2)
Croatian: 4 napunjene štrcaljke (0,6 ml) i 4 igle (27G1/2)
English: 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.
Croatian: 15. Uvedite iglu u kateter (slijedite upute dobavljača katetera)
English: Keep the pre-filled syringe in the outer carton, in order to protect from light.
Croatian: Napunjenu štrcaljku čuvajte u vanjskom pakiranju radi zaštite od svjetlosti.
English: Remove the needle and syringe from the injection port at the same angle as inserted.
Croatian: Izvucite iglu i štrcaljku iz katetera pod istim kutom pod kojim ste ih uveli.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 500 IU epoetin beta.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 500 IU epoetina beta.
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 20,000 IU solution for injection in pre-filled syringe Epoetin beta
Croatian: NeoRecormon 20 000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
English: 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)
Croatian: Liofilizat i otapalo za otopinu za injekciju 1 bočica s liofilizatom (50 000 IU) za otopinu za injekciju, 1 ampula s otapalom s konzervansom
English: Keep the pre-filled syringe in the outer carton, in order to protect from light
Croatian: Napunjenu štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 10,000 IU epoetin beta.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 10 000 IU epoetina beta.
English: 1 pre-filled syringe (0.6 ml) and 1 needle (27G1/2)
Croatian: 1 napunjena štrcaljka (0,6 ml) i 1 igla (27G1/2)
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 5000 IU solution for injection in pre-filled syringe Epoetin beta
Croatian: NeoRecormon 5000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/046
Croatian: EU/1/97/031/046
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 500 IU solution for injection in pre-filled syringe Epoetin beta
Croatian: NeoRecormon 500 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
English: 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).
Croatian: Stoga se bolesnicima kod kojih postoji sumnja ili kod kojih je potvrđeno da imaju neutralizirajuća antitijela na eritropoetin, ne smije uvoditi terapija lijekom NeoRecormon
English: Only one vial of NeoRecormon Multidose must be in use (i.e. reconstituted) at any one time.
Croatian: Istovremeno u primjeni (tj. pripremljena) treba biti samo jedna bočica lijeka NeoRecormon Multidose.
English: MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 3000 IU pre-filled syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 3000 IU napunjenu štrcaljku
English: Storage Instructions
Croatian: Prijavljivanje nuspojava
English: In this case you should not be switched to NeoRecormon.
Croatian: U tom slučaju ne biste smjeli biti prebačeni na liječenje lijekom
English: Always follow aseptic techniques.
Croatian: Čuvati na 2°C-8°C Uvijek se pridržavajte aseptičkih postupaka
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/035
Croatian: EU/1/97/031/035
English: The solution is administered subcutaneously at a dose of 3 x 250 IU/kg b.w.
Croatian: Otopina se daje supkutano u dozi od 3 x 250 IU/kg tjel. mase tjedno.
English: Medicinal product contains phenylalanine and sodium, see leaflet for further information
Croatian: Lijek sadrži fenilalanin i natrij.
English: 6 pre-filled syringes (0.3 ml) and 6 needles (27G1/2)
Croatian: 6 napunjenih štrcaljki (0,3 ml) i 6 igala (27G1/2)
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 4000 IU solution for injection in pre-filled syringe Epoetin beta
Croatian: NeoRecormon 4000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
English: INFORMATION IN BRAILLE neorecormon 3000 IU
Croatian: neorecormon 3000 IU
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 3000 IU epoetin beta.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 3000 IU epoetina beta.
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 30,000 IU solution for injection in pre-filled syringe Epoetin beta
Croatian: NeoRecormon 30 000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
English: 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).
Croatian: 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).
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 2000 IU solution for injection in pre-filled syringe Epoetin beta
Croatian: NeoRecormon 2000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
English: If you do not respond adequately to NeoRecormon, your doctor will check your dose and will inform you if you need to change doses.
Croatian: Ako ne budete odgovarali na lijek NeoRecormon na odgovarajući način, Vaš liječnik će provjeriti
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 4000 IU epoetin beta.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 4000 IU epoetina beta.
English: 6 pre-filled syringes (0.6 ml) and 6 needles (27G1/2)
Croatian: 6 napunjenih štrcaljki (0,6 ml) i 6 igala (27G1/2)
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 10,000 IU solution for injection in pre-filled syringe Epoetin beta
Croatian: NeoRecormon 10 000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
English: · 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.
Croatian: Nemojte dodirivati iglu nakon što skinete zatvarač igle.
English: 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).
Croatian: 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).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/034
Croatian: EU/1/97/031/034
English: Treatment of symptomatic chemotherapy-induced anaemia in cancer patients NeoRecormon should be administered by the subcutaneous route to patients with anaemia (e.g.
Croatian: Liječenje simptomatske anemije uzrokovane kemoterapijom u bolesnika s rakom
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/033
Croatian: EU/1/97/031/033
English: 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
Croatian: 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
English: · 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.
Croatian: 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.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/032
Croatian: EU/1/97/031/032
English: 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.
Croatian: ● provjeriti jeste li u stanju dati krv, osobito ako Vam je tjelesna masa manja od 50 kg
English: (content of accompanying solvent ampoule).
Croatian: (doza održavanja).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/043
Croatian: EU/1/97/031/043
English: 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.
Croatian: Treba izbjegavati trajnu razinu hemoglobina iznad 12 g/dl (7,5 mmol/l).
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 6000 IU solution for injection in pre-filled syringe Epoetin beta
Croatian: NeoRecormon 6000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/038
Croatian: EU/1/97/031/038
English: 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).
Croatian: 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).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/036
Croatian: EU/1/97/031/036
English: INFORMATION IN BRAILLE neorecormon 500 IU
Croatian: NeoRecormon 500 IU
English: Vascular disorders
Croatian: Organski sustav
English: NAME OF THE MEDICINAL PRODUCT NeoRecormon 3000 IU solution for injection in pre-filled syringe Epoetin beta
Croatian: NeoRecormon 3000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta