FrancophonIA/ELRC3.0 huggingface dataset:
English: Baxter Healthcare Ltd., Caxton Way, Thetford,
Spanish: Baxter Healthcare Ltd Caxton Way,
English: 38.6 g/l glucose anhydrate
Spanish: 38.6 g/l Glucosa anhidra
English: 951 mg/l; 1071 mg/l; 510 mg/l; 714 mg/l; 850 mg/l; 1020 mg/l; 955 mg/l; 850 mg/l; 570 mg/l; 595 mg/l; 510 mg/l; 646 mg/l; 720 mg/l; 300 mg/l; 1393 mg/l; 5380 mg/l; 184 mg/l; 51 mg/l; 4480 mg/l
Spanish: 951 mg/l; 1071 mg/l; 510 mg/l; 714 mg/l; 850 mg/l; 1020 mg/l; 955 mg/l; 850 mg/l; 570 mg/l; 595 mg/l; 510 mg/l; 646 mg/l; 720 mg/l; 300 mg/l; 1393 mg/l; 5380 mg/l;
English: 1.393 g, LMethionine Ph.Eur.
Spanish: 1.393 g, L-Metioninea Ph.Eur.
English: 1,1% amino acid
Spanish: 1,1% Aminoácidos
English: 13.6 g/l glucose anhydrate
Spanish: 13.6 g/l Glucosa anhidra
English: 0.595 g, Glycine Ph.Eur.
Spanish: 0.595 g, Glicina Ph.Eur.
English: 1.36% w/v/ 13.6mg/ml
Spanish: 1.36% p/v/ 13.6 mg/ml
English: 2.27 % w/v (22.7 mg/ml)
Spanish: 2.27% p/v (22.7 mg/ml)
English: Sodium Chloride 5.38 g/l Quantitative Composition of Sodium Lactate Lactic Acid 139 g
Spanish: Lactato de sodio 4.48 g/l Cloruro de sodio 5.38 g/l Composición cuantitativa de lactate de sodio
English: 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v
Spanish: 0,538% p/v 0,448% p/v 0,0184% p/v 0,0051% p/v
English: solution for haemodialysis, haemodiafiltration and haemofiltration hemodialysis
Spanish: Solución para hemodialisis, Hemodiafiltración y hemofiltración
English: Baxter Healthcare SA Moneen Rd Castlebar, Co. Mayo Ireland
Spanish: Eslovaquia Baxter Healthcare SA, Moneen Rd, Castlebar, Co. Mayo, Ireland
English: 3.86% w/v (38.6 mg/ml)
Spanish: 3.86% p/v (38.6 mg/ml)
English: 3.86% w/v/ 38.6mg/ml
Spanish: 3.86% p/v/ 38.6mg/ml
English: 2.27% w/v/ 22.7mg/ml
Spanish: 2.27% p/v/ 22.7 mg/ml
English: 1.020 g, LLysine hydrochloride Ph.Eur.
Spanish: 1.020 g, Clorhidrato de L-Lisina Ph.Eur.
English: 0.955 g, LHistidine Ph.Eur.
Spanish: 0.955 g, L-Histidina Ph.Eur.
English: 3,86% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v
Spanish: 3,86% p/v 0,538% p/v 0,448% p/v 0,0184% p/v 0,0051% p/v
English: L-Methionine 0.850 g/l L-Isoleucine 0.850 g/l L-Leucine 1.020 g/l L-Lysine (chlorhydrate) 0.955 g/l L-Histidine 0.714 g/l L-Arginine 1.071 g/l Calcium chloride dihydrate 0.184 g/l Magnesium chloride hexahydrate 0.051 g/l Sodium Lactate 4.48 g/l
Spanish: L-Tirosina 0.300 g/l L-Triptófano 0.270 g/l L-Fenilalanina 0.570 g/l L-Treonina 0.646 g/l L-Serina 0.510 g/l L-Prolina 0.595 g/l Glicina 0.510 g/l L-Alanina 0.951 g/l L-Valina 1.393 g/l L-Metionina 0.850 g/l L-Isoleucina 0.850 g/l L-Leucina 1.020 g/l L-Lisina (clorhidrato) 0.955 g/l L-Histidina 0.714 g/l L-Arginina 1.071 g/l Cloruro de calcio dihidrato 0.184 g/l
English: 0.300 g, L-Tryptophan Ph.Eur.
Spanish: 0.300 g, LTriptófano Ph.Eur.
English: 0.510 g, L-Alanine Ph.Eur.
Spanish: 0.510 g, LAlanina Ph.Eur.
English: sodium chloride 0.643%w/v; magnesium chloride 0.015%w/v; calcium chloride 0.026%w/v; glucoae 0.110%w/v; potassium chloride 0.015%w/v; sodium lactate 0.336%w/v solution for haemodialysis/hae mofiltration intraarterial use, intravenous use
Spanish: Cloruro de sodio 0.643%p/v; Cloruro de magnesio 0.015%p/v; Cloruro de calcio 0.026%p/v; Glucosa 0.110%p/v; Cloruro de potasio 0.015%p/v; Lactato de sodio 0.336%p/v
English: Icodextrin (75 g/l), Sodium chloride (5.4 g/l), Calcium chloride (0.257 g/l), Magnesium chloride (0.051 g/l), Sodium lactate solution (4.5 g/l)
Spanish: Cloruro de calcio (0.257 g/l), Cloruro de magnesio (0.051 g/l), Solución de lactato de sodio (4.5 g/l)
English: Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeistof
Spanish: Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis t of
English: Finland Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo
Spanish: Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland
English: Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeistof
Spanish: Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeistof
Spanish: Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis t of
English: Anhydrous glucose 22.7 g/L, sodium chloride 5.38 g/L, sodium-L(+) lactate 4.48 g/L, calcium chloride dihydrate 0.184 g/L, magnesium chloride hexahydrate 0.051 g/L
Spanish: Glucosa anhidra 22.7 g/l, cloruro de sodio 5.38 g/l, L-Lactato de sodio 4.48 g/l, cloruro de calcio dihidrato 0,184 g/l, cloruro de magnesio hexahidrato 0,051 g/l
English: 0.570 g, L-Threonine Ph.Eur.
Spanish: 0.570 g, LTreonina Ph.Eur.
English: Dianeal PD4 Glucose 2.27% w/v /22.7mg/ml magnseium chloride 0.005%w/v; glucose 2.27%w/v; sodium lactate 0.45%w/v; calcium chloride 0.018%w/v; sodium chloride 0.54%w/v
Spanish: Cloruro de magnesio 0.005%p/v; glucosa 2.27%p/v; Lactato de sodio 0.45%p/v; Cloruro de calcio 0.018%p/v;Cloruro de sodio 0.54%p
English: Anhydrous glucose 38.6 g/L, sodium chloride 5.38 g/L, sodium-L(+) lactate 4.48 g/L, calcium chloride dihydrate 0.184 g/L, magnesium chloride hexahydrate 0.051 g/L
Spanish: Glucosa anhidra 38.6 g/l, Cloruro de sodio 5.38 g/l, L-Lactato de sodio 4.48 g/l, Cloruro de calcio dihidrato 0,184 g/l, Cloruro de magnesio hexahidrato 0,051 g/l
English: 22,7g+5,38g+4,48g+0,184g+0,051g/l
Spanish: Dianeal PD4 Glucose 22,7g+5,38g+4,48g+0,184g+0,051 g/l
English: Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeistof
Spanish: Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeistof
Spanish: Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeistof
Spanish: Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis t of
English: Ireland Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE
Spanish: Reino Unido Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE
English: 42,5 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate
Spanish: 42,5 mg/ml Glucosa monohidrato; 5,38 mg/ml Cloruro de sodio; 0,184 mg/ml Cloruro de calcio dihidrato; 0,051 mg/ml Cloruro de magnesio hexahidrato; 4,48 mg/ml Lactato de sodio
English: Anhydrous glucose 13.6 g/L, sodium chloride 5.38 g/L, sodium-L(+) lactate 4.48 g/L, calcium chloride dihydrate 0.184 g/L, magnesium chloride hexahydrate 0.051 g/L
Spanish: Glucosa anhidra 13.6 g/l, cloruro de sodio 5.38 g/l, L-Lactato de sodio 4.48 g/l, cloruro de calcio dihidrato 0,184 g/l, cloruro de magnesio hexahidrato 0,051 g/l
English: 1,071 mg/ml Arginine; 0,714 mg/ml Histine; 0,955 mg/ml Lysine hydrochloride; 1,02 mg/ml Leucine; 0,85 mg/ml Isoleucine; 0,85 mg/ml Methionine; 1,393 mg/ml Valine; 0,951 mg/ml Alanine; 0,51 mg/ml Glycine; 0,595 mg/ml Proline; 0,51 mg/ml Serine; 0,646 mg/ml Threonine; 0,57 mg/ml Phenylalanine; 0,27 mg/ml Tryptophan; 0,3 mg/ml Tyrosine; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 5,38 mg/ml Sodium Chloride; 4,48 mg/ml Sodium Lactate
Spanish: 0,951 mg/ml Alanina; 0,51 mg/ml Glicina; 0,595 mg/ml Prolina; 0,51 mg/ml Serina; 0,646 mg/ml Treonina; 0,57 mg/ml Fenilalanina; 0,27 mg/ml Triptófano; 0,3 mg/ml Tirosina; 0,184 mg/ml Cloruro de calcio dihidrato; 0,051 mg/ml Cloruro de magnesio hexahidrato; 5,38 mg/ml Sodium Chloride; 4,48 mg/ml Lactato de sodio
English: Dianeal PD1 Glucose 1.36% w/v /13.6mg/ml magnesium chloride 0.015%w/v; calcium chloride 0.026%w/v; glucose 1.36%w/v; sodium lactate 0.39%w/v; sodium chloride 0.57%w/v
Spanish: Cloruro de magnesio 0.015%p/v; Cloruro de calcio 0.026%p/v; glucosa 1.36%p/v; Lactato de sodio 0.39%p/v; Cloruro de sodio 0.57%p/v
English: Dianeal PD4 Glucose 1.36% w/v /13.6mg/ml magnseium chloride 0.005%w/v; glucose 1.36%w/v; sodium lactate 0.45%w/v; calcium chloride 0.018%w/v; sodium chloride 0.54%w/v
Spanish: Cloruro de magnesio 0.005%p/v; glucosa 1.36%p/v; Lactato de sodio 0.45%p/v; Cloruro de calcio 0.018%p/v;Cloruro de sodio 0.54%p
English: Dianeal PD4 Glucose 3.86% w/v /38.6mg/ml magnseium chloride 0.005%w/v; glucose 3.86%w/v; sodium lactate 0.45%w/v; calcium chloride 0.018%w/v; sodium chloride 0.54%w/v
Spanish: Cloruro de magnesio 0.005%p/v; glucosa 3.86%p/v; Lactato de sodio 0.45%p/v; Cloruro de calcio 0.018%p/v;Cloruro de sodio 0.54%p
English: 15 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate
Spanish: 15 mg/ml Glucosa monohidrato; 5,38 mg/ml Cloruro de sodio; 0,184 mg/ml Cloruro de calcio dihidrato; 0,051 mg/ml Cloruro de magnesio hexahidrato; 4,48 mg/ml Lactato de sodio
English: Dianeal PD1 Glucose 3.86% w/v /38.6mg/ml magnesium chloride 0.015%w/v; calcium chloride 0.026%w/v; glucose 3.86%w/v; sodium lactate 0.39%w/v; sodium chloride 0.57%w/v
Spanish: Cloruro de magnesio 0.015%p/v; Cloruro de calcio 0.026%p/v; glucosa 3.86%p/v; Lactato de sodio 0.39%p/v; Cloruro de sodio 0.57%p/v
English: 25 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate
Spanish: 25 mg/ml Glucosa monohidrato; 5,38 mg/ml Cloruro de sodio; 0,184 mg/ml Cloruro de calcio dihidrato; 0,051 mg/ml Cloruro de magnesio hexahidrato; 4,48 mg/ml Lactato de sodio
English: 38,6g+5,38g+4,48g+0,184g+0,051g/l
Spanish: Dianeal PD4 Glucose 38,6g+5,38g+4,48g+0,184g+0,051 g/l
English: Calcium Chloride: 0.026% w/v. glucose 0.110%w/v; sodium lactate 0.336%w/v; sodium chloride 0.643%w/v; magnesium chloride 0.015%w/v solution for haemodialysis/hae mofiltration intraarterial use, intravenous use
Spanish: glucosa 0.110%p/v; Lactato de sodio 0.336%p/v; Cloruro de sodio 0.643%p/v; Cloruro de magnesio 0.015%p/v
English: 1.1 g / l 6.43 g / l 0.257 g / l 0.298 g / l 0.152 g / l 3.36 g / l solution for haemodialysis hemodialysis
Spanish: 1.1 g / l 6.43 g / l 0.257 g / l 0.298 g / l 0.152 g / l 3.36 g / l
English: 1,071 mg/ml Arginine; 0,714 mg/ml Histine; 0,955 mg/ml Lysine hydrochloride; 1,02 mg/ml Leucine; 0,85 mg/ml Isoleucine; 0,85 mg/ml Methionine; 1,393 mg/ml Valine; 0,951 mg/ml Alanine; 0,51 mg/ml Glycine; 0,595 mg/ml Proline; 0,51 mg/ml Serine; 0,646 mg/ml Threonine; 0,57 mg/ml Phenylalanine; 0,27 mg/ml Tryptophan; 0,3 mg/ml Tyrosine; 0,184 mg/ml Calcium Chloride Dihydrate;
Spanish: 0,951 mg/ml Alanina; 0,51 mg/ml Glicina; 0,595 mg/ml Prolina; 0,51 mg/ml Serina; 0,646 mg/ml Treonina; 0,57 mg/ml Fenilalanina; 0,27 mg/ml Triptófano; 0,3 mg/ml Tirosina; 0,184 mg/ml Cloruro de calcio dihidrato; 0,051 mg/ml Cloruro de magnesio hexahidrato; 5,38 mg/ml Cloruro de sodio; 4,48 mg/ml Lactato de sodio
English: 13,6g+5,38g+4,48g+0,184g+0,051g/l
Spanish: Dianeal PD4 Glucose 13,6g+5,38g+4,48g+0,184g+0,051 g/l
English: 1.1 g / l 6.43 g / l 0.257 g / l 0.149 g / l 0.152 g / l 3.36 g / l solution for haemodialysis hemodialysis
Spanish: 1.1 g / l 6.43 g / l 0.257 g / l 0.149 g / l 0.152 g / l 3.36 g / l
English: Dianeal PD1 Glucose 2.27% w/v /22.7mg/ml sodium chloride 0.57%w/v; glucose 2.27%w/v; magnesium chloride 0.015%w/v; sodium lactate 0.39%w/v; calcium chloride 0.026%w/v
Spanish: Cloruro de magnesio 0.015%p/v; Cloruro de calcio 0.026%p/v; glucosa 2.27%p/v; Lactato de sodio 0.39%p/v; Cloruro de sodio 0.57%p/v
English: 42,5 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0.257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate
Spanish: 42,5 mg/ml Glucosa monohidrato; 5,67 mg/ml Cloruro de sodio; 0.257 mg/ml Cloruro de calcio dihidrato; 0,152 mg/ml Cloruro de magnesio hexahidrato; 3,92 mg/ml Lactato de sodio
English: 15 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate
Spanish: 15 mg/ml Glucosa monohidrato; 5,67 mg/ml Cloruro de sodio; 0,257 mg/ml Cloruro de calcio dihidrato; 0,152 mg/ml Cloruro de magnesio hexahidrato; 3,92 mg/ml Lactato de sodio
English: 75g/L 5,4g/L 4,5g/L 0,257g/L 0,051g/L
Spanish: 75g/l 5,4g/l 4,5g/l 0,257g/l 0,051g/l Solución para diálisis peritoneal
English: 25 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate
Spanish: 25 mg/ml Glucosa monohidrato; 5,67 mg/ml Cloruro de sodio; 0,257 mg/ml Cloruro de calcio dihidrato; 0,152 mg/ml Cloruro de magnesio hexahidrato; 3,92 mg/ml Lactato de sodio
English: Glucose monohydrate 1.1 g/L, sodium chloride 6.43 g/L, sodium lactate 3.36 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L, potassium chloride 0.298 g/L
Spanish: Glucosa monohidrato 1.1 g/l, cloruro de sodio 6.43 g/l, L-lactato de sodio 3.36 g/l, Cloruro de calcio dihidrato 0.257 g/l, Cloruro de magnesio hexahidrato 0.152 g/l, Cloruro de potasio 0.298 g/l
English: 1,1% acides aminés
Spanish: 1,1 % Aminoácidos
English: Glucose monohydrate 1.1 g/L, sodium chloride 6.43 g/L, sodium lactate 3.36 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L
Spanish: Glucosa monohidrato 1.1 g/l, cloruro de sodio 6.43 g/l, L-lactato de sodio 3.36 g/l, Cloruro de calcio dihidrato 0.257 g/l, Cloruro de magnesio hexahidrato 0.152 g/l
English: 951 mg/l; 1071 mg/l; 510 mg/l; 714 mg/l; 850 mg/l; 1020 mg/l; 955 mg/l; 850 mg/l; 570 mg/l; 595 mg/l; 510 mg/l; 646 mg/l; 270 mg/l; 300 mg/l; 1393 mg/l; 5380 mg/l; 184 mg/l; 51 mg/l; 4480 mg/l
Spanish: 850 mg/l; 1020 mg/l; 955 mg/l; 850 mg/l; 570 mg/l; 595 mg/l; 510 mg/l; 646 mg/l;
English: Glucose monohydrate 1.1 g/L, sodium chloride 6.43 g/L, sodium lactate 3.36 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L, potassium chloride 0.149 g/L
Spanish: Glucosa monohidrato 1.1 g/l, Cloruro de sodio 6.43 g/l, L-lactato de sodio 3.36 g/l, Cloruro de calcio dihidrato 0.257 g/l, Cloruro de magnesio hexahidrato 0.152 g/l, Cloruro de potasio 0.149 g/l
English: Helsinki
Spanish: Rumanía
English: solution for haemodialysis, haemodiafiltration and haemofiltration intraarterial use, intravenous use, hemodialysis
Spanish: Via intraarterial, Via intravenosa, Hemodiálisis
English: 1.1 g / l 6.43 g / l 0.257 g / l 0.152 g / l 3.36 g / l solution for haemodialysis hemodialysis
Spanish: 1.1 g / l 6.43 g / l 0.257 g / l 0.152 g / l 3.36 g / l
English: Glucose Monohydrate 1.1 g/l, Sodium Chloride 6.43 g/l, Calcium Chloride Dihydrate 0.257 g/l, Magnesium Chloride Hexahydrate 0.152 g/l, Potassium Chloride 0.149 g/l, Sodium Lactate 3.36 g/l solution for haemodialysis/hae mofiltration intra-arterial use, intravenous use
Spanish: Glucosa monohidrato 1.1 g/l, Cloruro de sodio 6.43 g/l, Cloruro de calcio dihidrato 0.257 g/l, Cloruro de magnesio hexahidrato 0.152 g/l, Cloruro de potasio 0.149 g/l, Llactato de sodio 3.36 g/l
English: Nutrineal PD4 mit 1,1 % Aminosäuren
Spanish: Nutrineal PD4 mit 1,1 % Aminosauren
English: 1,36 % w/v / 13,6 mg/ml peritoneal use
Spanish: 1,36% p/v/13,6 mg/ml
English: Nutrineal PD4+A.A.1,1% 1,1% amino acids
Spanish: Nutrineal PD4+A.A.1,1
English: Glucose Monohydrate 1.1 g/l, Sodium Chloride 6.43 g/l, Calcium Chloride Dihydrate 0.257 g/l, Magnesium Chloride Hexahydrate 0.152 g/l, Sodium Lactate 3.36 g/l solution for haemodialysis/hae mofiltration intraarterial use, intravenous use
Spanish: Glucosa monohidrato 1.1 g/l, Cloruro de sodio 6.43 g/l, Cloruro de calcio dihidrato 0.257 g/l, Cloruro de magnesio hexahidrato 0.152 g/l, Lactato de sodio 3.36 g/l
English: 16 February 2012
Spanish: 16 de febrero de 2012
English: The application was withdrawn after ‘day 180'.
Spanish: La solicitud fue retirada después del «día 180».
English: What was the recommendation of the CHMP at that time?
Spanish: ¿Cuál era la recomendación del CHMP en ese momento?
English: The company also presented results of studies in humans, including one main study in 4,902 children.
Spanish: La empresa también presento los resultados de estudios realizados con seres humanos, incluido un estudio principal efectuado con 4 902 niños.
English: The applicant presented data on experimental models from similar vaccines.
Spanish: El solicitante presentó datos sobre modelos experimentales de vacunas similares.
English: The viruses have first been inactivated so that they do not cause any disease.
Spanish: Antes, los virus se han inactivado para que no produzcan ninguna enfermedad.
English: The shortcomings included incorrect data in the dossier submitted to the Agency, which greatly impacted the reliability of the study results.
Spanish: Los defectos incluyeron datos incorrectos en el dossier presentado a la Agencia, lo que afectó considerablemente a la fiabilidad de los resultados del estudio.
English: immune system will then be able to produce antibodies more quickly when it is exposed to the viruses again.
Spanish: Posteriormente, el sistema inmunológico podrá producir anticuerpos con más rapidez cuando se encuentre con los virus de nuevo.
English: Other main concerns were related to inadequate data from the company, including the data provided on children aged between six to nine years, children with health conditions and on revaccination.
Spanish: Otros problemas importantes estaban relacionados con la entrega de datos inadecuados por parte de la empresa, como los datos facilitados sobre niños de entre seis y nueve años de edad, sobre los niños con problemas de salud y sobre la revacunación.
English: The CHMP was particularly concerned by shortcomings in good clinical practice (GCP) that came to light following an inspection of the sites of the main study.
Spanish: El CHMP estaba particularmente interesado en los defectos en la buena práctica clínica (BPC) que salieron a la luz tras una inspección de los centros del estudio principal.
English: There were also concerns about deficiencies in the laboratory tests used to confirm whether patients had influenza or not.
Spanish: También tenía reservas sobre las deficiencias en las pruebas analíticas utilizadas para confirmar si los pacientes tenían gripe o no.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Spanish: Esto significa que el CHMP había evaluado la documentación presentada por la empresa y formulado una lista de preguntas.
English: On 10 February 2012, Novartis Vaccines and Diagnostics officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fluad Paediatric, for the prevention of seasonal influenza in infants and children.
Spanish: El 10 de febrero de 2012, Novartis Vaccines and Diagnostics notificó oficialmente al Comité de Medicamentos de Uso Humano (CHMP) que deseaba retirar su solicitud de autorización de comercialización de Fluad Pediátrico para la prevención de la gripe estacional en lactantes y niños.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Spanish: Las vacunas funcionan «enseñando» al sistema inmunológico (las defensas naturales del cuerpo) a defenderse de una enfermedad.
English: The company informed the CHMP that there are no consequences for people currently included in clinical trials using Fluad Paediatric.
Spanish: La empresa ha informado al CHMP de que no hay consecuencias para los pacientes que actualmente participan en ensayos clínicos con Fluad Pediátrico.
English: The vaccine contains an ‘adjuvant' to enhance the immune response.
Spanish: La vacuna contiene un «adyuvante» para potenciar la respuesta inmunitaria.
English: This may help to protect against the disease caused by the influenza viruses.
Spanish: Esto puede ayudar a proteger al cuerpo contra la enfermedad producida por los virus de la gripe.
English: When a person is given the vaccine, the immune system recognises the viral parts as ‘foreign' and makes antibodies against them.
Spanish: Cuando se administra una vacuna a una persona, el sistema inmunológico reconoce las partes virales como «extrañas» y fabrica anticuerpos contra ellas.
English: The vaccine is the same as a vaccine that is authorised in several EU countries to prevent seasonal flu in the elderly population.
Spanish: La vacuna es la misma autorizada en varios países de la UE para prevenir la gripe estacional en ancianos.
English: Fluad Paediatric was expected to be used to prevent influenza in infants and children aged from six months to less than nine years.
Spanish: Fluad Pediátrico estaba destinado a la prevención de la gripe en lactantes y niños desde los seis meses de edad a menos de nueve años.
English: The study was designed to take place over three flu seasons and looked at the number of cases of influenza that occurred in a season following vaccination.
Spanish: El diseño del estudio tenía prevista la administración durante tres estaciones de gripe e investigaba el número de casos de gripe que se producían durante una estación después de la vacunación.
English: What is Fluad Paediatric?
Spanish: ¿Qué es Fluad Pediátrico?
English: The children were given either Fluad Paediatric, another influenza vaccine (Agrippal or Influsplit) or a non-influenza vaccine (Menjugate or Encepur).
Spanish: Los niños recibieron Fluad pediátrico, otra vacuna contra la gripe (Agrippal o Influsplit) o una vacuna distinta a la de la gripe (Menjugate o Encepur).
English: In its letter notifying the Agency of the withdrawal of application, the company stated that its withdrawal was based on the fact that it was unable to address the concerns of the CHMP within the required timelines.
Spanish: En su escrito de notificación a la Agencia de la retirada de la solicitud, la empresa indicó que la retirada estaba justificada por el hecho de que no podía solventar las dudas del CHMP dentro de los plazos exigidos.
English: After the CHMP had assessed the company's responses to the first round of questions, there were still some unresolved issues.
Spanish: Una vez que el CHMP hubo evaluado las respuestas de la empresa a la primera serie de preguntas, aún quedaban algunas cuestiones pendientes.
English: Therefore, at the time of the withdrawal, the CHMP's conclusion was that the vaccine could not have been approved since the company had not addressed the Committee's main concerns.
Spanish: Por consiguiente, en el momento de la retirada, el CHMP concluyó que la vacuna no se hubiera podido aprobar ya que la empresa no había respondido debidamente a sus reservas.
English: The flu strains used to produce the vaccine was to depend on official recommendations for the annual flu season.
Spanish: Las cepas de la gripe utilizadas para producir la vacuna se elegían en función de las recomendaciones oficiales para la estación anual de gripe.
English: Fluad Paediatric is a vaccine to protect against seasonal influenza.
Spanish: Fluad pediátrico es una vacuna para proteger contra la gripe estacional.
English: Withdrawal of the marketing authorisation application for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted)
Spanish: Retirada de la solicitud de autorización de comercialización de Fluad Pediátrico (vacuna contra la gripe, antígeno de superficie, inactivad, adyuvada)
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had several major concerns.
Spanish: Tras la revisión de la documentación y las respuestas de la empresa a la lista de preguntas del CHMP, en el momento de la retirada, el CHMP tenía reservas importantes.
English: It contains proteins from three inactivated influenza (flu) virus strains.
Spanish: Contiene proteínas de tres cepas de virus de la gripe inactivados.
English: Fluad Paediatric contains proteins from three influenza virus strains.
Spanish: Fluad pediátrico contiene proteínas de tres cepas de virus de la gripe.
English: What was Fluad Paediatric expected to be used for?
Spanish: ¿A qué uso estaba destinado Fluad Pediátrico?
English: How is Fluad Paediatric expected to work?
Spanish: ¿Cómo estaba previsto que actuase Fluad pediátrico?
English: This summary was last updated on 26/10/2011.
Spanish: Fecha de la última actualización del presente resumen: 26/10/2011.