FrancophonIA/ELRC3.0 huggingface dataset:
English: Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe One pre-filled syringe contains 10,000 international units (IU) (83.3 µg) epoetin theta in 1 ml solution for injection corresponding to 10,000 IU (83.3 µg) epoetin theta per ml.
Slovenian: Eporatio 10.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 10.000 mednarodnih enot (i.e.) (83,3 µg) epoetina theta v 1 ml raztopine za injiciranje, kar ustreza 10.000 i.e. (83,3 µg) epoetina theta na ml.
English: Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe 30 months
Slovenian: Eporatio 5000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 30 mesecev
English: Eporatio 3,000 IU/0.5 ml: One pre-filled syringe contains 3,000 international units (IU) (25 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 6,000 international units (IU) (50 micrograms) per ml.
Slovenian: Eporatio 3000 i.e./0,5 ml: ena napolnjena injekcijska brizga vsebuje 3000 mednarodnih enot (i.e.) (25 mikrogramov) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 6000 mednarodnim enotam (i.e.) (50 mikrogramom) na ml.
English: Eporatio 2,000 IU/0.5 ml: One pre-filled syringe contains 2,000 international units (IU) (16.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 4,000 international units (IU) (33.3 micrograms) per ml.
Slovenian: Eporatio 2000 i.e./0,5 ml: ena napolnjena injekcijska brizga vsebuje 2000 mednarodnih enot (i.e.) (16,7 mikrograma) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 4000 mednarodnim enotam (i.e.) (33,3 mikrograma) na ml.
English: Eporatio 4,000 IU/0.5 ml
Slovenian: Eporatio 4000 i.e./0,5 ml
English: Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 5,000 international units (IU) (41.7 µg) epoetin theta in 0.5 ml solution for injection corresponding to 10,000 IU (83.3 µg) epoetin theta per ml.
Slovenian: Eporatio 5000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 5000 mednarodnih enot (i.e.) (41,7 µg) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 10.000 i.e. (83,3 µg) epoetina theta na ml.
English: Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 1,000 international units (IU) (8.3 µg) epoetin theta in 0.5 ml solution for injection corresponding to 2,000 IU (16.7 µg) epoetin theta per ml.
Slovenian: Eporatio 1000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 1000 mednarodnih enot (i.e.) (8,3 µg) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 2000 i.e. (16,7 µg) epoetina theta na ml.
English: Before you give yourself an Eporatio injection, you must do the following: Hold the syringe and gently remove the cover from the needle without twisting.
Slovenian: Primite brizgo in nežno odstranite pokrovček z igle, brez obračanja.
English: Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 4,000 international units (IU) (33.3 µg) epoetin theta in 0.5 ml solution for injection corresponding to 8,000 IU (66.7 µg) epoetin theta per ml.
Slovenian: Eporatio 4000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 4000 mednarodnih enot (i.e.) (33,3 µg) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 8000 i.e. (66,7 µg) epoetina theta na ml.
English: Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 3,000 international units (IU) (25 µg) epoetin theta in 0.5 ml solution for injection corresponding to 6,000 IU (50 µg) epoetin theta per ml.
Slovenian: Eporatio 3000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 3000 mednarodnih enot (i.e.) (25 µg) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 6000 i.e. (50 µg) epoetina theta na ml.
English: Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 2,000 international units (IU) (16.7 µg) epoetin theta in 0.5 ml solution for injection corresponding to 4,000 IU (33.3 µg) epoetin theta per ml.
Slovenian: Eporatio 2000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 2000 mednarodnih enot (i.e.) (16,7 µg) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 4000 i.e. (33,3 µg) epoetina theta na ml.
English: Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe EU/1/09/573/017
Slovenian: Eporatio 20.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/09/573/017
English: Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe EU/1/09/573/023
Slovenian: Eporatio 30.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/09/573/023
English: Contents of the pack and other information 7.
Slovenian: Shranjevanje zdravila Eporatio Vsebina pakiranja in dodatne informacije Informacije za samostojno injiciranje
English: Eporatio 20,000 IU/1 ml injection Epoetin theta
Slovenian: Eporatio 20.000 i.e./1 ml injekcija epoetin theta s.c., i.v.
English: Eporatio 5,000 IU/0.5 ml injection Epoetin theta
Slovenian: Eporatio 5000 i.e./0,5 ml injekcija epoetin theta s.c., i.v.
English: 6 pre-filled syringes with safety needle containing 1 ml.
Slovenian: 6 napolnjenih injekcijskih brizg z varnostno iglo, ki vsebujejo 1 ml.
English: Eporatio 3,000 IU/0.5 ml
Slovenian: Eporatio 3000 i.e./0,5 ml
English: Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe Epoetin theta
Slovenian: Eporatio 30.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin theta
English: Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe EU/1/09/573/011
Slovenian: Eporatio 10.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/09/573/011
English: Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe Epoetin theta
Slovenian: Eporatio 20.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin theta
English: Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe 30 months
Slovenian: Eporatio 20.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 30 mesecev
English: Eporatio 4,000 IU/0.5 ml injection Epoetin theta
Slovenian: Eporatio 4000 i.e./0,5 ml injekcija epoetin theta s.c., i.v.
English: Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Slovenian: Eporatio 1000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 2 leti
English: Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe Epoetin theta
Slovenian: Eporatio 10.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin theta
English: 1 pre-filled syringe with safety needle containing 1 ml.
Slovenian: 1 napolnjena injekcijska brizga z varnostno iglo, ki vsebuje 1 ml.
English: 4 pre-filled syringes with safety needle containing 1 ml.
Slovenian: 4 napolnjene injekcijske brizge z varnostno iglo, ki vsebujejo 1 ml.
English: Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Slovenian: Eporatio 5000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin theta
English: Eporatio 30,000 IU/1 ml injection Epoetin theta
Slovenian: Eporatio 30.000 i.e./1 ml injekcija epoetin theta s.c., i.v.
English: Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Slovenian: Eporatio 1000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin theta
English: Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/573/009
Slovenian: Eporatio 5000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/09/573/009
English: Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe 30 months
Slovenian: Eporatio 10.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 30 mesecev
English: Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/573/007
Slovenian: Eporatio 4000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/09/573/007
English: EU/1/09/573/009 6 pre-filled syringes
Slovenian: EU/1/09/573/009 6 napolnjenih injekcijskih brizg
English: Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Slovenian: Eporatio 4000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 2 leti
English: Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe 30 months
Slovenian: Eporatio 30.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 30 mesecev
English: Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Slovenian: Eporatio 4000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin theta
English: Eporatio 30,000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Slovenian: Eporatio 30.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
English: Eporatio 3,000 IU/0.5 ml injection Epoetin theta
Slovenian: Eporatio 3000 i.e./0,5 ml injekcija epoetin theta s.c., i.v.
English: Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Slovenian: Eporatio 3000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin theta
English: Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/573/005
Slovenian: Eporatio 3000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/09/573/005
English: Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Slovenian: Eporatio 3000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 2 leti
English: EU/1/09/573/007 6 pre-filled syringes
Slovenian: EU/1/09/573/007 6 napolnjenih injekcijskih brizg
English: EU/1/09/573/001 6 pre-filled syringes
Slovenian: EU/1/09/573/001 6 napolnjenih injekcijskih brizg
English: Eporatio 10,000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Slovenian: Eporatio 10.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
English: EU/1/09/573/010 6 pre-filled syringes with safety device EU/1/09/573/033 6 pre-filled syringes with safety needle
Slovenian: EU/1/09/573/040 1 napolnjena injekcijska brizga z varnostno iglo EU/1/09/573/041 4 napolnjene injekcijske brizge z varnostno iglo EU/1/09/573/042 6 napolnjenih injekcijskih brizg z varnostno iglo
English: Eporatio 10,000 IU/1 ml injection Epoetin theta
Slovenian: Eporatio 10.000 i.e./1 ml injekcija epoetin theta s.c., i.v.
English: Eporatio 1,000 IU/0.5 ml injection Epoetin theta
Slovenian: Eporatio 1000 i.e./0,5 ml injekcija epoetin theta s.c., i.v.
English: Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/573/001
Slovenian: Eporatio 1000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/09/573/001
English: Eporatio 20,000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Slovenian: Eporatio 20.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 1 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo
English: Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Slovenian: Eporatio 2000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin theta
English: Eporatio 5,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Slovenian: Eporatio 5000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,5 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
English: Epoetin theta
Slovenian: България Актавис ЕАД
English: EU/1/09/573/005 6 pre-filled syringes
Slovenian: EU/1/09/573/005 6 napolnjenih injekcijskih brizg
English: Eporatio 4,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Slovenian: Eporatio 4000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,5 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
English: What you need to know before you use Eporatio 3.
Slovenian: Kaj je zdravilo Eporatio in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Eporatio Kako uporabljati zdravilo Eporatio
English: EU/1/09/573/003 6 pre-filled syringes
Slovenian: EU/1/09/573/003 6 napolnjenih injekcijskih brizg
English: Eporatio 1,000 IU/0.5 ml
Slovenian: Eporatio 1000 i.e./0,5 ml
English: EU/1/09/573/004 6 pre-filled syringes with safety device EU/1/09/573/030 6 pre-filled syringes with safety needle
Slovenian: EU/1/09/573/013 4 napolnjene injekcijske brizge EU/1/09/573/014 4 napolnjene injekcijske brizge z varnostnim pripomočkom EU/1/09/573/015 6 napolnjenih injekcijskih brizg
English: Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Slovenian: Eporatio 2000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 2 leti
English: EU/1/09/573/002 6 pre-filled syringes with safety device EU/1/09/573/029 6 pre-filled syringes with safety needle
Slovenian: EU/1/09/573/024 1 napolnjena injekcijska brizga z varnostnim pripomočkom EU/1/09/573/025 4 napolnjene injekcijske brizge
English: Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Slovenian: Eporatio 1000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,5 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
English: Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/573/003
Slovenian: Eporatio 2000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/09/573/003
English: Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Slovenian: Eporatio 3000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,5 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
English: EU/1/09/573/017 1 pre-filled syringe EU/1/09/573/018 1 pre-filled syringe with safety device EU/1/09/573/019 4 pre-filled syringes EU/1/09/573/020 4 pre-filled syringes with safety device EU/1/09/573/021 6 pre-filled syringes EU/1/09/573/022 6 pre-filled syringes with safety device EU/1/09/573/037 1 pre-filled syringe with safety needle EU/1/09/573/038 4 pre-filled syringes with safety needle EU/1/09/573/039 6 pre-filled syringes with safety needle
Slovenian: EU/1/09/573/037 1 napolnjena injekcijska brizga z varnostno iglo EU/1/09/573/038 4 napolnjene injekcijske brizge z varnostno iglo EU/1/09/573/039 6 napolnjenih injekcijskih brizg z varnostno iglo
English: EU/1/09/573/006 6 pre-filled syringes with safety device EU/1/09/573/031 6 pre-filled syringes with safety needle
Slovenian: EU/1/09/573/034 1 napolnjena injekcijska brizga z varnostno iglo EU/1/09/573/035 4 napolnjene injekcijske brizge z varnostno iglo EU/1/09/573/036 6 napolnjenih injekcijskih brizg z varnostno iglo
English: Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Slovenian: Eporatio 2000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 0,5 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z vrhnjo zaporko (iz bromobutilne gume), batnim zamaškom (iz teflonizirane kromobutilne gume) in injekcijsko iglo (iz nerjavnega jekla) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pokrovčkom (z varnostno iglo) ali injekcijsko iglo (iz nerjavnega jekla) z varnostnim pripomočkom.
English: Eporatio 2,000 IU/0.5 ml injection Epoetin theta
Slovenian: Eporatio 2000 i.e./0,5 ml injekcija epoetin theta s.c., i.v.
English: 20 rue Diesel 01630 Saint Genis Pouilly FRANCE
Slovenian: 20 rue Diesel 01630 Saint Genis Pouilly FRANCIJA
English: This impact was addressed indirectly for two settings.
Slovenian: Ta vpliv je bil posredno obravnavan v dveh okoliščinah.
English: The CHMP also agreed with this approach.
Slovenian: CHMP se strinja s tem pristopom.
English: The Dosimetry Tables in section 11 already include calculated children's doses.
Slovenian: Tabele dozimetrije v 11. poglavju že vsebujejo izračunane odmerke za otroke.
English: This should be carefully differentiated to diagnostic performance.
Slovenian: To pa je treba natančno ločevati od diagnostične zmogljivosti.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF GLUSCAN 500 AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA GLUSCAN 500 IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: Because no agreement was reached at Day 60, the procedure was referred to the CHMP.
Slovenian: Ker do 60. dne ni bilo doseženo soglasje, je bil postopek napoten na Odbor za zdravila za uporabo v humani medicini (CHMP).
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA POZITIVNO MNENJE, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: The CHMP assessed the dossier and the available data, including the issues raised by the objecting CMS.
Slovenian: CHMP je ovrednotil dokumentacijo in razpoložljive podatke, vključno z vprašanji, ki so jih sprožile nasprotujoče zadevne države članice.
English: The CHMP agreed that there has been a long experience of continuous use of FDG, which support its well-established use.
Slovenian: CHMP se strinja, da obstajajo dolgotrajne izkušnje neprekinjene uporabe FDG, kar podpira njeno dobro uveljavljeno uporabo.
English: This was mostly reported in sarcoidosis and also in vasculitis (Rehàk 2006).
Slovenian: O tem so najpogosteje poročali pri sarkoidozi in tudi pri vaskulitisu (Rehàk 2006).
English: In addition FDG has already been registered in 3 EU Member States (EI, UK & CZ) for this “new” indication in infectious or inflammatory diseases, and the early results seen to be favourable in these countries, have been confirmed with experience of continuous use.
Slovenian: Poleg tega je FDG že registrirana v 3 državah članicah EU (EI, UK in CZ) za to „novo“ indikacijo pri okužbah oz. vnetnih boleznih in prvi rezultati v teh državah, ki so veljali kot ugodni, so bili potrjeni z izkušnjami neprekinjene uporabe.
English: The legal basis for this application refers to: Article 10(a) of Directive 2001/83/EC, as amended - relating to applications relying on well established medicinal use supported by bibliographic literature.
Slovenian: Pravna podlaga za to vlogo je člen 10(a) Direktive 2001/83/ES, kakor je bila spremenjena - o vlogah, ki se nanašajo na že uveljavljeno uporabo, ki jo podpirajo bibliografski viri.
English: Since FDG PET accurately diagnoses those conditions, the interference of those unavoidable therapies would certainly be considered to be minor.
Slovenian: Ker PET s FDG natančno postavi diagnozo teh stanj, bi interferenca omenjenih neizogibnih terapij gotovo štela za manj pomembno.
English: The Applicant claims that to the best of their knowledge (at this point in time), there has been no report about leukocyte dysfunction that leads to the fact they are unable to be activated in the vicinity of targets cells.
Slovenian: Predlagatelj trdi, da po njegovih zadnjih informacijah (do danes) ni bilo poročil o disfunkciji levkocitov, ki bi povzročila nezmožnost njihove aktivacije v bližini ciljnih celic.