FrancophonIA/ELRC3.0 huggingface dataset:
English: België/Belgique/Belgien CSL Behring NV
Croatian: België/Belgique/Belgien
English: Lonoctocog alfa 250 IU
Croatian: lonoktokog alfa 250 IU
English: Lonoctocog alfa 1000 IU
Croatian: lonoktokog alfa 1000 IU
English: Lonoctocog alfa 1500 IU
Croatian: lonoktokog alfa 1500 IU
English: 0 to <6 years (N=20) Mean (CV%) Median (Min,Max)
Croatian: Od 0 do <6 godina (N=20) Srednja vrijednost (KV %) Medijan (min., maks.)
English: Dizziness common
Croatian: Parestezija često
English: Perioperative management (surgical prophylaxis): A total of 16 major surgical procedures were performed and assessed in 13 subjects in Study 1001.
Croatian: Perioperacijsko liječenje (kirurška profilaksa): Izvedeno je ukupno 16 većih kirurških zahvata i procijenjeno je 13 ispitanika u ispitivanju 1001. Hemostatska djelotvornost jednolančanog faktora rVIII u kirurškoj profilaksi ocijenjena je kao izvrsna ili dobra u svim kirurškim zahvatima.
English: Lonoctocog alfa 2500 IU
Croatian: lonoktokog alfa 2500 IU
English: Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the powder vial stopper.
Croatian: Preokrenite bočicu s otapalom s pričvršćenim kompletom Mix2Vial i gurnite šiljak prozirnog kraja nastavka ravno prema dolje kroz čep bočice s praškom.
English: Lonoctocog alfa 500 IU
Croatian: lonoktokog alfa 500 IU
English: CSL Behring GmbH Emil-von-Behring Strasse 76 35041 Marburg GERMANY
Croatian: CSL Behring GmbH Emil-von-Behring Strasse 76 35041 Marburg NJEMAČKA
English: 5 ml of solvent in a vial (type I glass) with a stopper (rubber), a disc (plastic), and a cap (aluminium).
Croatian: 5 ml otapala u bočici (staklo tipa I) s čepom (gumenim), diskom (plastičnim), i prstenom (aluminijskim).
English: AFSTYLA 2000 IU powder and solvent for solution for injection
Croatian: AFSTYLA 2000 IU prašak i otapalo za otopinu za injekciju
English: 2.5 ml of solvent in a vial (type I glass) with a stopper (rubber), a disc (plastic), and a cap (aluminium).
Croatian: 2,5 ml otapala u bočici (staklo tipa I) s čepom (gumenim), diskom (plastičnim), i prstenom (aluminijskim).
English: Discard the solvent vial with the blue Mix2Vial adapter attached.
Croatian: Bacite bočicu otapala s pričvršćenim plavim nastavkom Mix2Vial.
English: AFSTYLA 250 IU powder and solvent for solution for injection Powder (250 IU) in a 6 ml vial (type I glass) with a stopper (rubber), an orange disc (plastic), and a green striped cap (aluminium).
Croatian: AFSTYLA 250 IU prašak i otapalo za otopinu za injekciju Prašak (250 IU) u bočici od 6 ml (staklo tipa I) s čepom (gumenim), narančastim diskom (plastičnim) i zelenim prugastim prstenom (aluminijskim).
English: AFSTYLA 3000 IU powder and solvent for solution for injection
Croatian: AFSTYLA 3000 IU prašak i otapalo za otopinu za injekciju
English: AFSTYLA 1500 IU powder and solvent for solution for injection Powder (1500 IU) in a 10 ml vial (type I glass) with a stopper (rubber), a turquoise disc (plastic), and a green striped cap (aluminium).
Croatian: AFSTYLA 1500 IU prašak i otapalo za otopinu za injekciju Prašak (1500 IU) u bočici od 10 ml (staklo tipa I) s čepom (gumenim), tirkiznim diskom (plastičnim) i zelenim prugastim prstenom (aluminijskim).
English: AFSTYLA 3000 IU powder and solvent for solution for injection Powder (3000 IU) in a 10 ml vial (type I glass) with a stopper (rubber), a yellow disc (plastic), and a green striped cap (aluminium).
Croatian: AFSTYLA 3000 IU prašak i otapalo za otopinu za injekciju Prašak (3000 IU) u bočici od 10 ml (staklo tipa I) s čepom (gumenim), žutim diskom (plastičnim) i zelenim prugastim prstenom (aluminijskim).
English: AFSTYLA 250 IU powder and solvent for solution for injection
Croatian: AFSTYLA 250 IU prašak i otapalo za otopinu za injekciju
English: • dizziness
Croatian: • zimica
English: AFSTYLA 1500 IU powder and solvent for solution for injection
Croatian: AFSTYLA 1500 IU prašak i otapalo za otopinu za injekciju
English: AFSTYLA 2500 IU powder and solvent for solution for injection
Croatian: AFSTYLA 2500 IU prašak i otapalo za otopinu za injekciju
English: AFSTYLA 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Croatian: AFSTYLA 2000 IU prašak i otapalo za otopinu za injekciju Svaka bočica sadrži nominalno 2000 IU rekombinantnog jednolančanog koagulacijskog faktora VIII (jednolančani faktor rVIII, INN = lonoktokog alfa).
English: AFSTYLA 500 IU powder and solvent for solution for injection Powder (500 IU) in a 6 ml vial (type I glass) with a stopper (rubber), a blue disc (plastic), and a green striped cap (aluminium).
Croatian: AFSTYLA 500 IU prašak i otapalo za otopinu za injekciju Prašak (500 IU) u bočici od 6 ml (staklo tipa I) s čepom (gumenim), plavim diskom (plastičnim) i zelenim prugastim prstenom (aluminijskim).
English: AFSTYLA 3000 IU powder for solution for injection Lonoctocog alfa
Croatian: AFSTYLA 3000 IU prašak za otopinu za injekciju lonoktokog alfa
English: AFSTYLA 1000 IU powder and solvent for solution for injection Powder (1000 IU) in a 6 ml vial (type I glass) with a stopper (rubber), a green disc (plastic), and a green striped cap (aluminium).
Croatian: AFSTYLA 1000 IU prašak i otapalo za otopinu za injekciju Prašak (1000 IU) u bočici od 6 ml (staklo tipa I) s čepom (gumenim), zelenim diskom (plastičnim) i zelenim prugastim prstenom (aluminijskim).
English: Attach the syringe to the threaded, locking end of the venipuncture kit.
Croatian: Pričvrstite štrcaljku na navojni, zaporni kraj seta za venepunkciju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 500 IU
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: AFSTYLA 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Croatian: AFSTYLA 3000 IU prašak i otapalo za otopinu za injekciju Svaka bočica sadrži nominalno 3000 IU rekombinantnog jednolančanog koagulacijskog faktora VIII (jednolančani faktor rVIII, INN = lonoktokog alfa).
English: 3000 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 600 IU/ml of lonoctocog alfa.
Croatian: 3000 IU po bočici; nakon rekonstitucije s 5 ml vode za injekcije otopina sadrži 600 IU/ml lonoktokoga alfa.
English: AFSTYLA 1000 IU powder and solvent for solution for injection
Croatian: AFSTYLA 1000 IU prašak i otapalo za otopinu za injekciju
English: AFSTYLA 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Croatian: AFSTYLA 250 IU prašak i otapalo za otopinu za injekciju Svaka bočica sadrži nominalno 250 IU rekombinantnog jednolančanog koagulacijskog faktora VIII (jednolančani faktor rVIII, INN = lonoktokog alfa).
English: 1500 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 300 IU/ml of lonoctocog alfa.
Croatian: 1500 IU po bočici; nakon rekonstitucije s 5 ml vode za injekcije otopina sadrži 300 IU/ml lonoktokoga alfa.
English: After reconstitution with 2.5 ml water for injections the solution contains 200 IU/ml of rVIII-SingleChain.
Croatian: Nakon rekonstitucije s 2,5 ml vode za injekcije, otopina sadrži 200 IU/ml jednolančanog faktora rVIII.
English: After filtering/withdrawal (see below) the reconstituted product should be inspected visually for particulate matter and discoloration prior to administration.
Croatian: (vidjeti u nastavku) rekonstituirani lijek treba se vizualno pregledati i utvrditi ima li čestica ili promjene boje prije primjene.
English: powder and solvent for solution for injection 1 vial with powder: 3000 IU lonoctocog alfa (600 IU/ml after reconstitution) 1 vial with 5 ml water for injections
Croatian: 1 bočica s praškom: 3000 IU lonoktokoga alfa (600 IU/ml nakon rekonstitucije) 1 bočica s 5 ml vode za injekcije
English: AFSTYLA 2000 IU powder and solvent for solution for injection Powder (2000 IU) in a 10 ml vial (type I glass) with a stopper (rubber), a purple disc (plastic), and a green striped cap (aluminium).
Croatian: AFSTYLA 2000 IU prašak i otapalo za otopinu za injekciju Prašak (2000 IU) u bočici od 10 ml (staklo tipa I) s čepom (gumenim), ljubičastim diskom (plastičnim) i zelenim prugastim prstenom (aluminijskim).
English: AFSTYLA 250 IU powder for solution for injection Lonoctocog alfa
Croatian: AFSTYLA 250 IU prašak za otopinu za injekciju lonoktokog alfa
English: After reconstitution with 2.5 ml water for injections the solution contains 100 IU/ml of rVIII-SingleChain.
Croatian: Nakon rekonstitucije s 2,5 ml vode za injekcije, otopina sadrži 100 IU/ml jednolančanog faktora rVIII.
English: AFSTYLA 2000 IU powder for solution for injection Lonoctocog alfa
Croatian: AFSTYLA 2000 IU prašak za otopinu za injekciju lonoktokog alfa
English: AFSTYLA 1500 IU powder for solution for injection Lonoctocog alfa
Croatian: AFSTYLA 1500 IU prašak za otopinu za injekciju lonoktokog alfa
English: 250 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 100 IU/ml of lonoctocog alfa.
Croatian: 250 IU po bočici; nakon rekonstitucije s 2,5 ml vode za injekcije otopina sadrži 100 IU/ml lonoktokoga alfa.
English: AFSTYLA 500 IU powder and solvent for solution for injection
Croatian: AFSTYLA 500 IU prašak i otapalo za otopinu za injekciju
English: 500 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 200 IU/ml of lonoctocog alfa.
Croatian: 500 IU po bočici; nakon rekonstitucije s 2,5 ml vode za injekcije otopina sadrži 200 IU/ml lonoktokoga alfa.
English: The PK parameters were based on plasma factor VIII activity measured by the chromogenic substrate assay (for discrepancy in the factor VIII activity determined with one-stage clotting assay, please see section 4.2).The PK profile obtained 3 to 6 months after the initial PK assessment was comparable with the PK profile obtained after the first dose.
Croatian: Farmakokinetički parametri temelje se na aktivnosti faktora VIII u plazmi koja je mjerena testom s kromogenim supstratom (za odstupanja u aktivnosti faktora VIII koja se određuje jednostupanjskim testom koagulacije vidjeti dio 4.2).
English: 1000 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 400 IU/ml of lonoctocog alfa.
Croatian: 1000 IU po bočici; nakon rekonstitucije s 2,5 ml vode za injekcije otopina sadrži 400 IU/ml lonoktokoga alfa.
English: AFSTYLA 2500 IU powder and solvent for solution for injection Each vial contains nominally 2500 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Croatian: AFSTYLA 2500 IU prašak i otapalo za otopinu za injekciju Svaka bočica sadrži nominalno 2500 IU rekombinantnog jednolančanog koagulacijskog faktora VIII (jednolančani faktor rVIII, INN = lonoktokog alfa).
English: AFSTYLA 2500 IU powder for solution for injection Lonoctocog alfa
Croatian: AFSTYLA 2500 IU prašak za otopinu za injekciju lonoktokog alfa
English: When reconstituted with 5 ml water for injections the solution contains 600 IU/ml of rVIII-SingleChain.
Croatian: Nakon rekonstitucije s 5 ml vode za injekcije, otopina sadrži 600 IU/ml jednolančanog faktora rVIII.
English: AFSTYLA 3000 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Croatian: AFSTYLA 3000 IU prašak i otapalo za otopinu za injekciju lonoktokog alfa (rekombinantni koagulacijski faktor VIII)
English: powder and solvent for solution for injection 1 vial with powder: 1500 IU lonoctocog alfa (300 IU/ml after reconstitution) 1 vial with 5 ml water for injections
Croatian: 1 bočica s praškom: 1500 IU lonoktokoga alfa (300 IU/ml nakon rekonstitucije) 1 bočica s 5 ml vode za injekcije
English: powder and solvent for solution for injection 1 vial with powder: 2500 IU lonoctocog alfa (500 IU/ml after reconstitution) 1 vial with 5 ml water for injections
Croatian: 1 bočica s praškom: 2500 IU lonoktokog alfa (500 IU/ml nakon rekonstitucije) 1 bočica s 5 ml vode za injekcije
English: powder and solvent for solution for injection 1 vial with powder: 1000 IU lonoctocog alfa (400 IU/ml after reconstitution) 1 vial with 2.5 ml water for injections
Croatian: 1 bočica s praškom: 1000 IU lonoktokoga alfa (400 IU/ml nakon rekonstitucije) 1 bočica s 2,5 ml vode za injekcije
English: AFSTYLA 1000 IU powder for solution for injection Lonoctocog alfa
Croatian: AFSTYLA 1000 IU prašak za otopinu za injekciju lonoktokog alfa
English: powder and solvent for solution for injection 1 vial with powder: 2000 IU lonoctocog alfa (400 IU/ml after reconstitution) 1 vial with 5 ml water for injections
Croatian: 1 bočica s praškom: 2000 IU lonoktokoga alfa (400 IU/ml nakon rekonstitucije) 1 bočica s 5 ml vode za injekcije
English: AFSTYLA 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Croatian: AFSTYLA 1500 IU prašak i otapalo za otopinu za injekciju Svaka bočica sadrži nominalno 1500 IU rekombinantnog jednolančanog koagulacijskog faktora VIII (jednolančani faktor rVIII, INN = lonoktokog alfa).
English: After reconstitution with 2.5 ml water for injections the solution contains 400 IU/ml of rVIII-SingleChain.
Croatian: Nakon rekonstitucije s 2,5 ml vode za injekcije, otopina sadrži 400 IU/ml jednolančanog faktora rVIII.
English: Hypersensitivity common
Croatian: Poremećaji imunosnog sustava Preosjetljivost često
English: AFSTYLA 2000 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Croatian: AFSTYLA 2000 IU prašak i otapalo za otopinu za injekciju lonoktokog alfa (rekombinantni koagulacijski faktor VIII)
English: AFSTYLA 250 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Croatian: AFSTYLA 250 IU prašak i otapalo za otopinu za injekciju lonoktokog alfa (rekombinantni koagulacijski faktor VIII)
English: 2500 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 500 IU/ml of lonoctocog alfa.
Croatian: 2500 IU po bočici; nakon rekonstitucije s 5 ml vode za injekcije otopina sadrži 500 IU/ml lonoktokoga alfa.
English: AFSTYLA 2500 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Croatian: AFSTYLA 2500 IU prašak i otapalo za otopinu za injekciju lonoktokog alfa (rekombinantni koagulacijski faktor VIII)
English: 2000 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 400 IU/ml of lonoctocog alfa.
Croatian: 2000 IU po bočici; nakon rekonstitucije s 5 ml vode za injekcije otopina sadrži 400 IU/ml lonoktokoga alfa.
English: When reconstituted with 5 ml water for injections the solution contains 500 IU/ml of rVIII-SingleChain.
Croatian: Nakon rekonstitucije s 5 ml vode za injekcije, otopina sadrži 500 IU/ml jednolančanog faktora rVIII.
English: AFSTYLA 1500 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Croatian: AFSTYLA 1500 IU prašak i otapalo za otopinu za injekciju lonoktokog alfa (rekombinantni koagulacijski faktor VIII)
English: AFSTYLA 500 IU powder for solution for injection Lonoctocog alfa
Croatian: AFSTYLA 500 IU prašak za otopinu za injekciju lonoktokog alfa
English: AFSTYLA 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Croatian: AFSTYLA 1000 IU prašak i otapalo za otopinu za injekciju Svaka bočica sadrži nominalno 1000 IU rekombinantnog jednolančanog koagulacijskog faktora VIII (jednolančani faktor rVIII, INN = lonoktokog alfa).
English: AFSTYLA 1000 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Croatian: AFSTYLA 1000 IU prašak i otapalo za otopinu za injekciju lonoktokog alfa (rekombinantni koagulacijski faktor VIII)
English: When reconstituted with 5 ml water for injections the solution contains 300 IU/ml of rVIII-SingleChain.
Croatian: Nakon rekonstitucije s 5 ml vode za injekcije, otopina sadrži 300 IU/ml jednolančanog faktora rVIII.
English: powder and solvent for solution for injection 1 vial with powder: 250 IU lonoctocog alfa (100 IU/ml after reconstitution) 1 vial with 2.5 ml water for injections 1 filter transfer device 20/20
Croatian: 1 bočica s praškom: 250 IU lonoktokoga alfa (100 IU/ml nakon rekonstitucije) 1 bočica s 2,5 ml vode za injekcije
English: When reconstituted with 5 ml water for injections the solution contains 400 IU/ml of rVIII-SingleChain.
Croatian: Nakon rekonstitucije s 5 ml vode za injekcije, otopina sadrži 400 IU/ml jednolančanog faktora rVIII.
English: AFSTYLA 500 IU powder and solvent for solution for injection Lonoctocog alfa (recombinant coagulation factor VIII)
Croatian: AFSTYLA 500 IU prašak i otapalo za otopinu za injekciju lonoktokog alfa (rekombinantni koagulacijski faktor VIII)
English: AFSTYLA 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU recombinant, single-chain coagulation factor VIII (rVIIISingleChain, INN = lonoctocog alfa).
Croatian: AFSTYLA 500 IU prašak i otapalo za otopinu za injekciju Svaka bočica sadrži nominalno 500 IU rekombinantnog jednolančanog koagulacijskog faktora VIII (jednolančani faktor rVIII, INN = lonoktokog alfa).
English: powder and solvent for solution for injection 1 vial with powder: 500 IU lonoctocog alfa (200 IU/ml after reconstitution) 1 vial with 2.5 ml water for injections 1 filter transfer device 20/20
Croatian: 1 bočica s praškom: 500 IU lonoktokoga alfa (200 IU/ml nakon rekonstitucije) 1 bočica s 2,5 ml vode za injekcije
English: Tél/Tel: +32 15 28 89 20
Croatian: CSL Behring NV Tél/Tel: +32 15 28 89 20
English: United Kingdom Hikma Farmacêutica (Portugal), S.A.
Croatian: Hikma Farmacêutica (Portugal), S.A.
English: Lyophilisate And Solvent For Solution For Injection
Croatian: Liofilizat i otapalo za otopinu za injekciju
English: Metilprednisolon Teva Methylprednisolone 40mg/Ml
Croatian: Metilprednisolon Teva Metilprednizolon 40 mg/ml
English: Metilprednizolon Teva Methylprednisolone 40mg/Ml
Croatian: Metilprednizolon Teva Metilprednizolon 40 mg/ml
English: Pfizer, Spol.
Croatian: Češka Republika Pfizer, Spol.
English: Pfizer S.A. (Belgium) Olu-Medrol S.A.B.
Croatian: Pfizer S.A. (Belgium) Olu-Medrol S.A.B. (= Sine Alcohol
English: Methylprednisolone Hemisuccinate 50.68mg Bottle
Croatian: Metilprednizolon hemisukcinat boca od 50,68 mg
English: Methylprednisolone Hemisuccinate 25.34mg Bottle
Croatian: Metilprednizolon hemisukcinat boca od 25,34 mg
English: Methylprednisolone Sodium Succinate 53.03mg/Ml
Croatian: Metilprednizolon natrijev sukcinat 53,03 mg/ml
English: Methylprednisolone Hemisuccinate 50.7mg Vial
Croatian: Metilprednizolon hemisukcinat bočica od 50,7 mg
English: Metylprednizolón Hikma Methylprednisolone 53mg Vial
Croatian: Metylprednizolón Hikma Metilprednizolon bočica od 53 mg
English: Methylprednisolone 120mg Bottle
Croatian: Metilprednizolon boca od 120 mg
English: Methylprednisolone Hemisuccinate 25.35mg Vial
Croatian: Metilprednizolon hemisukcinat bočica od 25,35 mg
English: Methylprednisolone Sodium Succinate 53.2mg/Ml
Croatian: Metilprednizolon natrijev sukcinat 53,2 mg/ml
English: Metilprednisolon Teva Methylprednisolone Sodium Succinate 53mg Vial
Croatian: Metilprednisolon Teva Metilprednizolon natrijev sukcinat bočica od 53 mg
English: Invented name Strength Pharmaceutical Form Route of administration
Croatian: Doza Farmaceutski oblik Put primjene
English: ©EMEA 2007
Croatian: 10 bočica©EMEA
English: Packaging Content
Croatian: Pakiranje Sastav
English: Further information on EndolucinBeta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o proizvodu EndolucinBeta nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: These tumours affect hormonesecreting cells in many parts of the body, including the pancreas, intestine, stomach and lungs.
Croatian: Ovi tumori utječu na stanice koje luče hormone u mnogim dijelovima tijela, uključujući gušteraču, crijeva, želudac i pluća.
English: The most common side effects with EndolucinBeta (which may affect more than 1 in 10 people) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leucopenia (low white blood cell counts), lymphopenia (low levels of lymphocytes, a particular type of white blood cell), nausea (feeling sick), vomiting and mild and temporary hair loss.
Croatian: Najčešće su nuspojave proizvoda EndolucinBeta (koje se mogu pojaviti u više od 1 na 10 osoba) anemija (niska razina crvenih krvnih stanica), trombocitopenija (niska razina trombocita), leukopenija (mali broj bijelih krvnih stanica), limfopenija (nizak broj limfocita, posebne vrste bijelih krvnih stanica), mučnina (osjećaj slabosti), povraćanje te umjeren i prolazan gubitak kose.
English: Radiolabelling is a technique for tagging (or labelling) medicines with radioactive compounds so they can carry radioactivity to where it is needed in the body, for example, the site of a tumour.
Croatian: Radioaktivno označavanje jest tehnika za označavanje (ili etiketiranje) lijekova radioaktivnim spojevima kako bi mogli prenositi radioaktivnost do mjesta u tijelu gdje je to potrebno, primjerice do mjesta tumora.
English: EndolucinBeta (lutetium (177Lu) chloride) EMA/554249/2018
Croatian: EndolucinBeta (lutecijev (177Lu) klorid) EMA/554249/2018
English: However, the quantity of EndolucinBeta to be used is very small and therefore these risks are considered low.
Croatian: Međutim, količina proizvoda EndolucinBeta koju je potrebno upotrijebiti vrlo je mala te se stoga i rizici smatraju malima.
English: When a medicine radiolabelled with EndolucinBeta is given to a patient, it carries the radiation to where it is needed in the body, either to kill cancer cells (when used for treatment) or to obtain images on a screen (when used for diagnosis).
Croatian: Kada se lijek radioaktivno označen proizvodom EndolucinBeta daje bolesniku, on prenosi zračenje do mjesta u tijelu gdje je to potrebno kako bi ubio stanice raka (kad se koristi za liječenje) ili kako bi se dobile slike na zaslonu (kad se koristi za dijagnozu).
English: The doctor will ensure that the expected benefit to the patients of using EndolucinBeta outweigh the risks linked to the radioactivity.
Croatian: Liječnik će osigurati da očekivane koristi proizvoda EndolucinBeta za bolesnika nadmašuju rizike povezane s radioaktivnošću.
English: What measures are being taken to ensure the safe and effective use of EndolucinBeta?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena proizvoda EndolucinBeta?
English: Medicines radiolabelled with EndolucinBeta must not be used in women unless pregnancy has been ruled out.
Croatian: Lijekovi radioaktivno označeni proizvodom EndolucinBeta ne smiju se primjenjivati u žena kod kojih nije isključena trudnoća.
English: Side effects reported with EndolucinBeta are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za proizvod EndolucinBeta pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The radiolabelled medicine is then given to the patient according to the instructions in that medicine's product information.
Croatian: Radioaktivno označen lijek zatim se daje bolesniku u skladu s uputama u informacijama o dotičnom lijeku.
English: EndolucinBeta itself is radioactive, and as with any other radioactive product, its use may carry a risk of developing cancer and defects that are passed on to children.
Croatian: EndolucinBeta radioaktivan je sam po sebi te, kao i u slučaju svih ostalih radioaktivnih proizvoda, njegova primjena može predstavljati rizik od razvoja raka i nasljednih oštećenja.