FrancophonIA/ELRC3.0 huggingface dataset:
English: Nutrineal PD4 mit 1,1 % AminosäurenPeritonealdialyselösung alanine 951 mg/L, arginine 1071 mg/L, glycine 510 mg/L, histidine 714 mg/L, isoleucine 850 mg/L, leucine 1020 mg/L, lysine hydrochloride 955 mg/L, methionine 850 mg/L, phenylalanine 570 mg/L, proline 595 mg/L, serine 510 mg/L, threonine 646 mg/L, tryptophan 270 mg/L, tyrosine 300 mg/L, valine 1393 mg/L, sodium chloride 5380 mg/L, calcium chloride dihydrate 184 mg/L, magnesium chloride hexahydrate 51 mg/L, sodium(s)-lactate 4480 mg/L
Romanian: Nutrineal PD4 mit 1,1 % AminosäurenPeritonealdialyselösung alanină 951 mg/L, arginina 1071 mg/L, glicină 510 mg/L, histidină 714 mg/L, izoleucină 850 mg/L, leucină 1020 mg/L, clorhidrat de lizină 955 mg/L, metionină 850 mg/L, fenilalanină 570 mg/L, prolină 595 mg/L, serină 510 mg/L, treonină 646 mg/L, triptofan 270 mg/L, tirozină 300 mg/L, valină 1393 mg/L, clorură de sodiu 5380 mg/L, clorură de calciu dihidrat 184 mg/L, clorură de magneziu hexahidrat 51 mg/L, lactat (s)- de sodiu 4480 mg/L
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
Romanian: L-Alanină 0.951 g/l L-Valină 1.393 g/l L-Metionină 0.850 g/l L-Isoleucină 0.850 g/l L-Leucină 1.020 g/l L-Lizină (chlorhidrat) 0.955 g/l L-Histidină 0.714 g/l L-Arginină 1.071 g/l Clorură de calciu dihidrat 0.184 g/l Clorură de magneziu hexahidrat 0.051 g/l
English: Nutrineal PD4 with 1.1% Amino Acids tyrosine 0.03%w/v; tryptophan 0.027%w/v; phenylalanine 0.057%w/v; threonine 0.064%w/v; L-serine 0.051%w/v; L-proline 0.058%w/v; glycine 0.051%w/v; L-alanine 0.095%w/v; valine 0.139%w/v; methionine 0.085%w/v; isoleucine 0.085%w/v; leucine 0.102%w/v; lysine 0.095%w/v; histidine 0/071%w/v; arginine 0.107%w/v; calcium chloride 0.018%w/v; magnesium chloride 0.005%w/v; sodium chloride 0.538%w/v; sodium s-lactate 0.448%w/v
Romanian: 0.095%w/v; valină 0.139%w/v; metionină 0.085%w/v; izoleucină 0.085%w/v; leucină 0.102%w/v; lizină 0.095%w/v; histidină 0/071%w/v; arginină 0.107%w/v; clorură de calciu 0.018%w/v; clorură de magneziu 0.005%w/v; clorură de sodiu 0.538%w/v; lactat-s de sodiu 0.448%w/v
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
Romanian: Dianeal PD1 Glucose 2.27% w/v /22.7mg/ml clorură de sodiu 0.57%w/v; glucoză 2.27%w/v; clorură de magneziu 0.015%w/v; lactat de sodiu 0.39%w/v; clorură de calciu 0.026%w/v
English: 3.86 % w/v or Glucose Monohydrate Ph.Eur.
Romanian: Glucoză anhidră Ph.Eur. 3.86 % w/v sau glucoză monohidrat Ph.Eur. 4.25 % w/v
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
Romanian: Dianeal PD4 Glucose 2.27% w/v /22.7mg/ml clorură de magneziu 0.005%w/v; glucoză 2.27%w/v; lactat de sodiu 0.45%w/v; clorură de calciu 0.018%w/v; clorură de sodiu 0.54%w/v
English: solution for haemodialysis, haemodiafiltration and haemofiltration hemodialysis
Romanian: Soluţie pentru hemodializă, hemodiafiltrare şi hemofiltrare
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
Romanian: Dianeal PD1 Glucose 3.86% w/v /38.6mg/ml clorură de magneziu 0.015%w/v; clorură de calciu 0.026%w/v; glucoză 3.86%w/v; lactat de sodiu 0.39%w/v; clorură de sodiu 0.57%w/v
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
Romanian: Dianeal PD1 Glucose 1.36% w/v /13.6mg/ml clorură de magneziu 0.015%w/v; clorură de calciu 0.026%w/v; glucoză 1.36%w/v; lactat de sodiu 0.39%w/v; clorură de sodiu 0.57%w/v
English: solution for dialysis peritoneal
Romanian: Solution for peritoneal dialysis
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
Romanian: 1,071 mg/ml Arginină; 0,714 mg/ml Histină; 0,955 mg/ml Lizină hidroclorică; 1,02 mg/ml Leucină; 0,85 mg/ml Izoleucină; 0,85 mg/ml Metionină; 1,393 mg/ml Valină; 0,951 mg/ml Alanină; 0,51 mg/ml Glicină; 0,595 mg/ml Prolină; 0,51 mg/ml Serină; 0,646 mg/ml Treonină; 0,57 mg/ml Fenilalanină; 0,27 mg/ml Triptofan; 0,3 mg/ml Tirozină; 0,184 mg/ml Clorură de calciu dihidrat; 0,051 mg/ml clorură de magneziu hexahidrat; 5,38 mg/ml clorură de sodiu; 4,48 mg/ml Lactat de sodiu
English: 2.27 % w/v or Glucose Monohydrate Ph.Eur.
Romanian: Glucoză anhidră Ph.Eur. 2.27 % w/v sau glucoză monohidrat Ph.Eur. 2.50 % w/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
Romanian: Dianeal PD4 Glucose 1.36% w/v /13.6mg/ml clorură de magneziu 0.005%w/v; glucoză 1.36%w/v; lactat de sodiu 0.45%w/v; clorură de calciu 0.018%w/v; clorură de sodiu 0.54%w/v
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
Romanian: Dianeal PD4 Glucose 3.86% w/v /38.6mg/ml clorură de magneziu 0.005%w/v; glucoză 3.86%w/v; lactat de sodiu 0.45%w/v; clorură de calciu 0.018%w/v; clorură de sodiu 0.54%w/v
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
Romanian: Clorură de calciu: 0.026% w/v. glucoză 0.110%w/v; lactat de sodiu 0.336%w/v; clorură de sodiu 0.643%w/v; clorură de magneziu 0.015%w/v
English: Finland Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo
Romanian: Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland
English: 42.50 g/l; 5.38 g/l; 4.48 g/l; 0.184 g/l; 0.051 g/l
Romanian: 42.50 g/l; 5.38 g/l; 4.48 g/l; 0.184 g/l;
English: Strength
Romanian: Intravenoasă
English: 1.36 % w/v or Glucose Monohydrate Ph.Eur.
Romanian: Glucoză anhidră Ph.Eur. 1.36 % w/v sau glucoză monohidrat Ph.Eur. 1.50 % w/v
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;
Romanian: 1,071 mg/ml Arginină; 0,714 mg/ml Histidină; 0,955 mg/ml Lizină hidroclorică; 1,02 mg/ml Leucină; 0,85 mg/ml Isoleucină; 0,85 mg/ml Metionină; 1,393 mg/ml Valină; 0,951 mg/ml Alanină; 0,51 mg/ml Glicină; 0,595 mg/ml Prolină; 0,51 mg/ml Serină; 0,646 mg/ml Treonină; 0,57 mg/ml Fenilalanină;
English: Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeistof
Romanian: Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeistof
Romanian: Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeistof
Romanian: 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
Romanian: Glucoză anhidră 22.7 g/L, clorură de sodiu 5.38 g/L, lactat-L (+) de sodiu 4.48 g/L, clorură de calciu dihidrat 0,184 g/L, clorură de magneziu hexahidrat 0,051 g/L
English: 15.0 g/l; 5.38 g/l; 4.48 g/l; 0.184 g/l; 0.051 g/l
Romanian: 15.0 g/l; 5.38 g/l; 4.48 g/l; 0.184 g/l;
English: Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland
Romanian: Baxter Healthcare S.A. Moneen Road Castlebar, County Mayo lreland
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
Romanian: Glucoză anhidră 38.6 g/L, clorură de sodiu 5.38 g/L, lactat-L (+) de sodiu 4.48 g/L, clorură de calciu dihidrat 0,184 g/L, clorură de magneziu hexahidrat 0,051 g/L
English: 22,7g+5,38g+4,48g+0,184g+0,051g/l
Romanian: 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
Romanian: Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeistof
Romanian: Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of
English: 3,86% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v
Romanian: 3,86% w/v 0,538% w/v 0,448% w/v
English: 25.0 g/l; 5.38 g/l; 4.48 g/l; 0.184 g/l; 0.051 g/l
Romanian: 25.0 g/l; 5.38 g/l; 4.48 g/l; 0.184 g/l;
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
Romanian: Glucoză anhidră 13.6 g/L, clorură de sodiu 5.38 g/L, lactat-L (+) de sodiu 4.48 g/L, clorură de calciu dihidrat 0,184 g/L, clorură de magneziu hexahidrat 0,051 g/L
English: Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeistof
Romanian: Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis t of
English: Baxter Healthcare SA Moneen Rd Castlebar, Co. Mayo Ireland
Romanian: Baxter Healthcare SA, Moneen Rd, Castlebar, Co.
English: 1,36% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v
Romanian: 1,36% w/v 0,538% w/v 0,448% w/v
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
Romanian: 42,5 mg/ml glucoză monohidrat; 5,38 mg/ml clorură de sodiu; 0,184 mg/ml clorură de calciu dihidrat; 0,051 mg/ml clorură de magneziu hexahidrat; 4,48 mg/ml lactat de sodiu
English: 38,6g+5,38g+4,48g+0,184g+0,051g/l
Romanian: Dianeal PD4 Glucose 38,6g+5,38g+4,48g+0,184g+0,051 g/l
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
Romanian: 15 mg/ml glucoză monohidrat; 5,38 mg/ml clorură de sodiu; 0,184 mg/ml clorură de calciu dihidrat; 0,051 mg/ml clorură de magneziu hexahidrat; 4,48 mg/ml lactat de sodiu
English: 42.50 g/l; 5.67 g/l; 3.92 g/l; 0.257 g/l; 0.152 g/l
Romanian: 42.50 g/l; 5.67 g/l; 3.92 g/l; 0.257 g/l;
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
Romanian: 25 mg/ml glucoză monohidrat; 5,38 mg/ml clorură de sodiu; 0,184 mg/ml clorură de calciu dihidrat; 0,051 mg/ml clorură de magneziu hexahidrat; 4,48 mg/ml lactat de sodiu
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
Romanian: 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: 13,6g+5,38g+4,48g+0,184g+0,051g/l
Romanian: 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
Romanian: 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: 0.538 % w/v Sodium Lactate Ph.Eur.
Romanian: Clorură de sodiu Ph.Eur. 0.538 % w/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
Romanian: 42,5 mg/ml glucoză monohidrat; 5,67 mg/ml clorură de sodiu; 0.257 mg/ml clorură de calciu dihidrat; 0,152 mg/ml clorură de magneziu hexahidrat; 3,92 mg/ml lactat de sodiu
English: 25.0 g/l; 5.67 g/l; 3.92 g/l; 0.257 g/l; 0.152 g/l
Romanian: 25.0 g/l; 5.67 g/l; 3.92 g/l; 0.257 g/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 0.298 g/L
Romanian: Glucoză monohidrat 1.1 g/L, clorură de sodiu 6.43 g/L, lactat de sodiu 3.36 g/L, clorură de calciu dihidrat 0.257 g/L, clorură de magneziu hexahidrat 0.152 g/L clorură de potasiu 0.298 g/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
Romanian: Glucoză monohidrat 1.1 g/L, clorură de sodiu 6.43 g/L, lactat de sodiu 3.36 g/L, clorură de calciu dihidrat 0.257 g/L, clorură de magneziu hexahidrat 0.152 g/L
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
Romanian: 15 mg/ml glucoză monohidrat; 5,67 mg/ml clorură de sodiu; 0,257 mg/ml clorură de calciu dihidrat; 0,152 mg/ml clorură de magneziu hexahidrat; 3,92 mg/ml lactat de sodiu
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
Romanian: 25 mg/ml glucoză monohidrat; 5,67 mg/ml clorură de sodiu; 0,257 mg/ml clorură de calciu dihidrat; 0,152 mg/ml clorură de magneziu hexahidrat; 3,92 mg/ml lactat de sodiu
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
Romanian: Glucoză monohidrat 1.1 g/L, clorură de sodiu 6.43 g/L, lactat de sodiu 3.36 g/L, clorură de calciu dihidrat 0.257 g/L, clorură de magneziu hexahidrat 0.152 g/L clorură de potasiu 0.149 g/L
English: Romania BAXTER HEALTHCARE S.A. Moneen Road, Castelbar, County Mayo
Romanian: Baxter Healthcare SA, Moneen Road, Castlebar, County Mayo, Ireland
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
Romanian: 1.1 g / l 6.43 g / l 0.257 g / l 0.152 g / l 3.36 g / l
English: 1,36 % w/v / 13,6 mg/ml peritoneal use
Romanian: 1,36% w/v/13,6 mg/ml
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
Romanian: 0.026%w/v; glucoză 0.110%w/v; clorură de potasiu 0.015%w/v; lactat de sodiu
English: Sweden Baxter Healthare SA Moneen Road
Romanian: Baxter Healthcare SA Moneen Road Castlebar
English: Nutrineal PD4 mit 1,1 % Aminosäuren
Romanian: Nutrineal PD4 mit 1,1 % Aminosauren
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
Romanian: Glucoză monohidrat 1.1 g/l, clorură de sodiu 6.43 g/l, clorură de calciu dihidrat 0.257 g/l, clorură de magneziu hexahidrat 0.152 g/l, clorură de potasiu 0.149 g/l, lactat de sodiu 3.36 g/l
English: 0.39 % w/v Calcium Chloride Ph.Eur.
Romanian: Clorură de sodiu Ph.Eur. 0.57 % w/v Lactat de sodiu Ph.Eur. 0.39 % w/v Clorură de calciu Ph.Eur. 0.0257 % w/v
English: Nutrineal PD4+A.A.1,1% 1,1% amino acids
Romanian: Nutrineal PD4+A.A.1,1
English: 16 February 2012
Romanian: 16 februarie 2012
English: Questions and answers
Romanian: Întrebări i răspunsuri
English: The application was withdrawn after ‘day 180'.
Romanian: Cererea a fost retrasă după „ziua 180”.
English: The company also presented results of studies in humans, including one main study in 4,902 children.
Romanian: Compania a prezentat, de asemenea, rezultate din studii pe subiecţi umani , inclusiv un studiu principal pe 4 902 copii.
English: The applicant presented data on experimental models from similar vaccines.
Romanian: Solicitantul a prezentat date din modele experimentale pentru vaccinuri similare.
English: immune system will then be able to produce antibodies more quickly when it is exposed to the viruses again.
Romanian: Astfel, sistemul imunitar poate produce anticorpi mai repede când este expus din nou la viru i.
English: The company informed the CHMP that there are no consequences for people currently included in clinical trials using Fluad Paediatric.
Romanian: Compania a informat CHMP că nu există consecinţe pentru persoanele incluse în prezent în studii clinice care utilizează Fluad Paediatric.
English: The viruses have first been inactivated so that they do not cause any disease.
Romanian: Viru ii au fost inactiva i astfel încât să nu poată cauza nicio boală.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Romanian: Vaccinurile ac ionează prin „învăţarea” sistemului imunitar (apărarea naturală a organismului) cum să se apere împotriva unei boli.
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.
Romanian: La data de 10 februarie 2012, Novartis Vaccines and Diagnostics a informat oficial Comitetul pentru medicamente de uz uman (CHMP) că dore te să îşi retragă cererea de autorizare de introducere pe piaţă pentru Fluad Paediatric, folosit pentru prevenirea gripei sezoniere la sugari şi copii.
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.
Romanian: Alte motive importante de îngrijorare priveau datele incorecte furnizate de companie, între care datele cu privire la copiii cu vârste între ase i nouă ani, la copiii cu probleme de sănătate i la revaccinare.
English: The vaccine contains an ‘adjuvant' to enhance the immune response.
Romanian: Vaccinul con ine un „adjuvant” pentru a amplifica răspunsul imun.
English: What is Fluad Paediatric?
Romanian: Ce este Fluad Paediatric?
English: When a person is given the vaccine, the immune system recognises the viral parts as ‘foreign' and makes antibodies against them.
Romanian: Când unei persoane i se administrează vaccinul, sistemul imunitar recunoa te păr ile virale ca fiind „străine” i produce anticorpi împotriva lor.
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.
Romanian: Prin urmare, la data retragerii, concluzia CHMP a fost că vaccinul nu putea fi aprobat deoarece compania nu soluţionase principalele motive de îngrijorare ale comitetului.
English: There were also concerns about deficiencies in the laboratory tests used to confirm whether patients had influenza or not.
Romanian: Au existat i observa ii despre deficien e în analizele de laborator utilizate pentru a confirma dacă pacien ii au gripă sau nu.
English: The children were given either Fluad Paediatric, another influenza vaccine (Agrippal or Influsplit) or a non-influenza vaccine (Menjugate or Encepur).
Romanian: Copiilor le-a fost administrat fie Fluad Paediatric, fie alt vaccin antigripal (Agrippal sau Influsplit) fie un vaccin non-gripal (Menjugate sau Encepur).
English: The vaccine is the same as a vaccine that is authorised in several EU countries to prevent seasonal flu in the elderly population.
Romanian: Vaccinul este acela i cu vaccinul care este autorizat în mai multe ări ale UE pentru a preveni gripa sezonieră la popula ia în vârstă.
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.
Romanian: Principala preocupare a CHMP erau deficien ele de bună practică clinică (BPC) constatate ca urmare a inspec iei la locurile studiului principal.
English: The shortcomings included incorrect data in the dossier submitted to the Agency, which greatly impacted the reliability of the study results.
Romanian: Deficien ele priveau datele incorecte din dosarul prezentat agen iei, care au afectat în mare măsură încrederea în rezultatele studiului.
English: What were the reasons given by the company for withdrawing the application?
Romanian: Care au fost motivele invocate de companie pentru retragerea cererii ?
English: After the CHMP had assessed the company's responses to the first round of questions, there were still some unresolved issues.
Romanian: După evaluarea de către CHMP a răspunsurilor companiei la prima rundă de întrebări, mai rămăseseră încă unele probleme nerezolvate.
English: The flu strains used to produce the vaccine was to depend on official recommendations for the annual flu season.
Romanian: Tulpinile de virus utilizate pentru a produce vaccinul urmau să depindă de recomandările oficiale pentru sezonul gripal anual.
English: Withdrawal of the marketing authorisation application for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted) EMA/CHMP/114709/2012
Romanian: Retragerea cererii de autorizare de introducere pe piaţă pentru Fluad Paediatric (vaccin antigripal, antigen de suprafață, inactivat, cu adjuvant) EMA/CHMP/114709/2012
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.
Romanian: În scrisoarea de notificare către agenţie privind retragerea cererii, compania a declarat că retragerea s-a bazat pe faptul că nu putea să soluţioneze motivele de îngrijorare ale CHMP în termenul stabilit.
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.
Romanian: Studiul a fost planificat să dureze trei sezoane de gripă i a determinat numărul de cazuri de gripă care au fost depistate în sezonul următor vaccinării.
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.
Romanian: Pe baza analizării datelor i a răspunsurilor companiei la lista de întrebări a CHMP, în momentul retragerii, CHMP avea câteva motive importante de îngrijorare.
English: Fluad Paediatric was expected to be used to prevent influenza in infants and children aged from six months to less than nine years.
Romanian: Fluad Paediatric ar fi trebuit să se utilizeze la prevenirea gripei la sugari şi copii cu vârste între ase luni si nouă ani.
English: Fluad Paediatric contains proteins from three influenza virus strains.
Romanian: Fluad Paediatric conţine proteine din trei tulpini de virus.
English: Fluad Paediatric is a vaccine to protect against seasonal influenza.
Romanian: Fluad Paediatric este un vaccin pentru protec ie împotriva gripei sezoniere.
English: This may help to protect against the disease caused by the influenza viruses.
Romanian: Acest lucru poate ajuta la protec ia împotriva bolii cauzate de viru ii gripali.
English: Withdrawal of the marketing authorisation application for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted)
Romanian: Retragerea cererii de autorizare de introducere pe piaţă pentru Fluad Paediatric (vaccin antigripal, antigen de suprafa ă, inactivat, cu adjuvant)
English: What was Fluad Paediatric expected to be used for?
Romanian: Pentru ce ar fi trebuit să se utilizeze Fluad Paediatric?