natgillin/translations-raw huggingface dataset:
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) 
Ikodekstriin (75 g/l), Naatriumkloriid (5.4 g/l), Kaltsiumkloriid (0.257 g/l), Magneesiumkloriid (0.051 g/l), Naatriumlaktaadi lahus (4.5 g/l)
0.850 g, L-Isoleucine Ph.Eur. 
0.850 g, L-Isoleutsetiin Ph.Eur.
1.393 g, LMethionine Ph.Eur. 
1.393 g, L-Metioniin Ph.Eur.
1.020 g, LLysine hydrochloride Ph.Eur. 
1.020 g, L-Lüsiinhüdrokloriid Ph.Eur.
3.86 % w/v or Glucose Monohydrate Ph.Eur. 
3.86 % w/v or Glükoosmonohüdraat Ph.Eur.
0.850 g, L-Leucine Ph.Eur. 
0.850 g, L-Leutsiin Ph.Eur.
solution for haemodialysis, haemodiafiltration and haemofiltration intraarterial use, intravenous use, hemodialysis 
Hemodialüüsi,hemodiafiltratsioonija hemofiltratsioonilahus intraarteriaalne, intravenoosne,
1.36 % w/v or Glucose Monohydrate Ph.Eur. 
1.36 % w/v or Glükoosmonohüdraat Ph.Eur.
0.57 % w/v Sodium Lactate Ph.Eur. 
0.57 % w/v Naatriumlaktaat Ph.Eur.
2.27 % w/v or Glucose Monohydrate Ph.Eur. 
2.27 % w/v or Glükoosmonohüdraat Ph.Eur.
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 
Dianeal PD1 Glucose 2.27% w/v /22.7mg/ml naatriumkloriid 0.57%w/v; glükoos 2.27%w/v; magneesiumkloriid 0.015%w/v; naatriumlaktaat 0.39%w/v; kaltsiumkloriid 0.026%w/v
0.595 g, Glycine Ph.Eur. 
0.595 g, Glütsiin Ph.Eur.
Anhydrous Glucose Ph.Eur. 
Veevaba glüskoos Ph.Eur.
75 mg/ml Icodextrin; 5,4 mg/ml Sodium Chloride; 4,5 mg/ml Sodium (S) - lactate solution; 0,051 mg/ml Magnesium Chloride; 0,257 mg/ml Calcium Chloride 
75 mg/ml Ikodekstriin; 5,4 mg/ml Naatriumkloriid; 4,5 mg/ml naatrium (S) - laktaadilahus; 0,051 mg/ml Magneesiumkloriid; 0,257 mg/ml Kaltsiumkloriid
1,1% amino acid 
1,1% Aminohapped
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 
Nutrineal PD4 mit 1,1 % AminosäurenPeritonealdialyselösung alaniini 951 mg/L, arginiini 1071 mg/L, glütsiin 510 mg/L, histidiin 714 mg/L, isoleutsiin 850 mg/L, leutsiin 1020 mg/L, lüsiin vesinikkloriidi 955 mg/L, metioniini 850 mg/L, fenüülalaniini 570 mg/L, proliini 595 mg/L, seriini 510 mg/L, treoniin 646 mg/L, trüptofaan 270 mg/L, türosiini 300 mg/L, valiin 1393 mg/L, Naatriumkloriid 5380 mg/L, Kaltsiumkloriid 184 mg/L, Magneesiumkloriid 51 mg/L, Naatrium(S)-laktaat 4480 mg/L
Glucose Monohydrate Ph. Eur. 
Magneesiumkloriidheksahüdraat Ph. Eur.
0.955 g, LHistidine Ph.Eur. 
0.955 g, L-Histidiin Ph.Eur.
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 
Dianeal PD4 Glucose 2.27% w/v /22.7mg/ml magneesiumkloriid 0.005%w/v; glükoos 2.27%w/v; naatriumlaktaat 0.45%w/v; kaltsiumkloriid 0.018%w/v; naatriumkloriid 0.54%w/v
1.36% W/V 2,27% W/V 3,86% W/V 
2,27% w/v 3,86%w/v
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 
L-Türosiin 0.300 g/l L-Trüptofaan 0.270 g/l L-Fenüülalaniin 0.570 g/l L-Treoniin 0.646 g/l L-Seriin 0.510 g/l L-Proliin 0.595 g/l Glütsiin 0.510 g/l L-Alaniin 0.951 g/l L-Valiin 1.393 g/l L-Metioniin 0.850 g/l L-Isoleutsiin 0.850 g/l L-Leutsiin 1.020 g/l L-Lüsiin (kloorhüdraat) 0.955 g/l L-Histidiin 0.714 g/l L-Arginiin 1.071 g/l Kaltsiumkloriiddihüdraat 0.184 g/l Magneesiumkloriidheksahüdraat 0.051 g/l
38.6 g/l glucose anhydrate 
38.6 g/l Veevaba glükoos
0.270 g, L-Phenylalanine Ph.Eur. 
0.270 g, LFenüülalaniin Ph.Eur.
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 
Dianeal PD1 Glucose 1.36% w/v /13.6mg/ml magneesiumkloriid 0.015%w/v; kaltsiumkloriid 0.026%w/v; glükoos 1.36%w/v; naatriumlaktaat 0.39%w/v; naatriumkloriid 0.57%w/v
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 
Dianeal PD4 Glucose 1.36% w/v /13.6mg/ml magneesiumkloriid 0.005%w/v; glükoos 1.36%w/v; naatriumlaktaat 0.45%w/v; kaltsiumkloriid 0.018%w/v; naatriumkloriid 0.54%w/v
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 
Dianeal PD4 Glucose 3.86% w/v /38.6mg/ml magneesiumkloriid 0.005%w/v; glükoos 3.86%w/v; naatriumlaktaat 0.45%w/v; kaltsiumkloriid 0.018%w/v; naatriumkloriid 0.54%w/v
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 
Dianeal PD1 Glucose 3.86% w/v /38.6mg/ml magneesiumkloriid 0.015%w/v; kaltsiumkloriid 0.026%w/v; glükoos 3.86%w/v; naatriumlaktaat 0.39%w/v; naatriumkloriid 0.57%w/v
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; 
1,071 mg/ml Arginiin; 0,714 mg/ml Histiin; 0,955 mg/ml Lüsiinhüdrokloriid; 1,02 mg/ml Leutsiin; 0,85 mg/ml Isoleutsiin; 0,85 mg/ml Metioniin; 1,393 mg/ml Valiin; 0,951 mg/ml Alaniin; 0,51 mg/ml Glütsiin; 0,595 mg/ml Proliin; 0,51 mg/ml Seriin; 0,646 mg/ml Treoniin; 0,57 mg/ml Fenüülalaniin; 0,27 mg/ml Trüptofaan; 0,3 mg/ml Türosiin; 0,184 mg/ml
Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeistof 
Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis t of
13.6 g/l glucose anhydrate 
13.6 g/l Veevaba glükoos
0.510 g, L-Proline Ph.Eur. 
0.510 g, L-Proliin Ph.Eur.
Finland Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo 
Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland
0.570 g, L-Threonine Ph.Eur. 
0.570 g, LThreoniin Ph.Eur.
0.300 g, L-Tryptophan Ph.Eur. 
0.300 g, LTrüptofaan Ph.Eur.
Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeistof 
Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of
22,7 g/l glucose anhydrate 
22.7 g/l Veevaba glükoos
Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeistof 
Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis t of
22,7g+5,38g+4,48g+0,184g+0,051g/l 
Dianeal PD4 Glucose 22,7g+5,38g+4,48g+0,184g+0,051 g/l
Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeistof 
Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis t of
Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeistof 
Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of
Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeistof 
Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis t of
3,86% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v 
3,86% w/v 0,538% w/v 0,448% w/v
0.510 g, L-Alanine Ph.Eur. 
0.510 g, LAlaniin Ph.Eur.
1,36% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v 
1,36% w/v 0,538% w/v 0,448% w/v
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 
Veevaba glükoos 22.7 g/L, Naatriumkloriid 5.38 g/L, Naatrium(S)-laktaat 4.48 g/L, Kaltsiumkloriid 0,184 g/L, Magneesiumkloriid 0,051 g/L
solution for dialysis peritoneal 
Solución para diálisis peritoneal
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 
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;
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 
Glükoosmonohüdraat 1.1 g/L, naatriumkloriid 6.43 g/L, naatriumlaktaat 3.36 g/L, kaltsiumkloriiddihüdraat 0.257 g/L, magneesiumkloriidheksahüdraat 0.152 g/L, kaaliumkloriid 0.298 g/L
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 
Veevaba glükoos 38.6 g/L, Naatriumkloriid 5.38 g/L, Naatrium(S)-laktaat 4.48 g/L, Kaltsiumkloriid 0,184 g/L, Magneesiumkloriid 0,051 g/L
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 
Veevaba glükoos 13.6 g/L, Naatriumkloriid 5.38 g/L, Naatrium(S)-laktaat 4.48 g/L, Kaltsiumkloriid 0,184 g/L, Magneesiumkloriid 0,051 g/L
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 
Glükoosmonohüdraat 1.1 g/L, naatriumkloriid 6.43 g/L, naatriumlaktaat 3.36 g/L, kaltsiumkloriiddihüdraat 0.257 g/L, magneesiumkloriidheksahüdraat 0.152 g/L, kaaliumkloriid 0.149 g/L
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 
0.110%w/v; naatriumlaktaat 0.336%w/v; naatriumkloriid 0.643%w/v; magneesiumkloriid 0.015%w/v
38,6g+5,38g+4,48g+0,184g+0,051g/l 
Dianeal PD4 Glucose 38,6g+5,38g+4,48g+0,184g+0,051 g/l
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 
42,5 mg/ml Glükoosmonohüdraat; 5,38 mg/ml Naatriumkloriid; 0,184 mg/ml Kaltsiumkloriiddihüdraat; 0,051 mg/ml
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 
42,5 mg/ml Glükoosmonohüdraat; 5,67 mg/ml Naatriumkloriid; 0,257 mg/ml Kaltsiumkloriiddihüdraat; 0,152 mg/ml
Dianeal PD4 med glucos 13,6 mg/ml 
Dianeal PD4 Glucose 13,6 mg/ml
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 
1.1 g / l 6.43 g / l 0.257 g / l 0.298 g / l 0.152 g / l 3.36 g / l
13,6g+5,38g+4,48g+0,184g+0,051g/l 
Dianeal PD4 Glucose 13,6g+5,38g+4,48g+0,184g+0,051 g/l
Ireland Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom 
Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom
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 
1.1 g / l 6.43 g / l 0.257 g / l 0.149 g / l 0.152 g / l 3.36 g / l
Sodium Chloride 5.38 g/l Quantitative Composition of Sodium Lactate Lactic Acid 139 g 
Naatriumlaktaat 4.48 g/l Naatriumkloriid 5.38 g/l Naatriumlaktaadi kvantitatiivne koostis
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 
15 mg/ml Glükoosmonohüdraat; 5,38 mg/ml Naatriumkloriid; 0,184 mg/ml Kaltsiumkloriiddihüdraat; 0,051 mg/ml
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 
15 mg/ml Glükoosmonohüdraat; 5,67 mg/ml Naatriumkloriid; 0,257 mg/ml Kaltsiumkloriiddihüdraat; 0,152 mg/ml
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 
25 mg/ml Glükoosmonohüdraat; 5,67 mg/ml Naatriumkloriid; 0,257 mg/ml Kaltsiumkloriiddihüdraat; 0,152 mg/ml
Annex I 
Ühendkuningri ik
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 
25 mg/ml Glükoosmonohüdraat; 5,38 mg/ml Naatriumkloriid; 0,184 mg/ml Kaltsiumkloriiddihüdraat; 0,051 mg/ml
Dianeal PD4 med glucos 38,6 mg/ml 
Dianeal PD4 Glucose 38,6 mg/ml
0.051 g, Sodium-lactate Ph.Eur. 
0.051 g, Naatrium(S)laktaat Ph.Eur.
solution for haemodialysis, haemodiafiltration and haemofiltration hemodialysis 
Hemodialüüsi,hemodiafiltratsioonija hemofiltratsioonilahus
1.1 g / l 6.43 g / l 0.257 g / l 0.152 g / l 3.36 g / l solution for haemodialysis hemodialysis 
1.1 g / l 6.43 g / l 0.257 g / l 0.152 g / l 3.36 g / l
1,36 % w/v / 13,6 mg/ml peritoneal use 
1,36% w/v/ 13,6 mg/ml
Nutrineal PD4 mit 1,1 % Aminosäuren 
Nutrineal PD4 mit 1,1 % Aminosauren
magnesium chloride 0.015%w/v; potassium chloride 0.029%w/v; calcium chloride 0.026%w/v; sodium lactate 0.336%w/v; sodium chloride 0.643%w/v; glucose 0.110%w/v solution for haemodialysis/hae mofiltration intraarterial use, intravenous use 
0.026%w/v; naatriumlaktaat 0.336%w/v; naatriumkloriid 0.643%w/v; glükoos 0.110%w/v
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 
0.026%w/v; glükoos 0.110%w/v; kaaliumkloriid 0.015%w/v; naatriumlaktaat
Nutrineal PD4+A.A.1,1% 1,1% amino acids 
Nutrineal PD4+A.A.1,1
16 February 2012 
16. veebruar 2012
The viruses have first been inactivated so that they do not cause any disease. 
Viirused on inaktiveeritud, et nad ei põhjustaks haigusi.
The company also presented results of studies in humans, including one main study in 4,902 children. 
Ettevõte esitas ka inimuuringute tulemused, sealhulgas ühe põhiuuringu tulemused, milles osales 4902 last.
The applicant presented data on experimental models from similar vaccines. 
Taotleja esitas sarnaste vaktsiinide eksperimentaalmudelitest pärinevad andmed.
This may help to protect against the disease caused by the influenza viruses. 
See võib aidata kaitsta haiguse eest, mida gripiviirus põhjustab.
There were also concerns about deficiencies in the laboratory tests used to confirm whether patients had influenza or not. 
Samuti kahtlustati puudujääke laboratoorsetes testides, mille abil tehti kindlaks, kas patsientidel oli gripp või mitte.
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. 
Uuring kavatseti läbi viia kolme gripihooaja jooksul ja see vaatles gripijuhtude arvu, mis esinesid vaktsineerimisele järgnenud hooaja jooksul.
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. 
Muud tõsised probleemid olid seotud ettevõtte esitatud andmetega, mis puudutasid muu hulgas 69-aastasi lapsi, terviseprobleemidega lapsi ja revaktsineerimist.
The shortcomings included incorrect data in the dossier submitted to the Agency, which greatly impacted the reliability of the study results. 
Puuduste hulka kuulusid Euroopa Ravimiametile esitatud toimikus sisaldunud ebakorrektsed andmed, mis mõjutasid oluliselt uuringutulemuste usaldusväärsust.
What is Fluad Paediatric? 
Mis on Fluad Paediatric?
The children were given either Fluad Paediatric, another influenza vaccine (Agrippal or Influsplit) or a non-influenza vaccine (Menjugate or Encepur). 
Lastele anti kas Fluad Paediatricut, muud gripivaktsiini (Agrippal või Influsplit) või mitte-gripivaktsiini (Menjugate või Encepur).
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease. 
Vaktsiinid n-ö õpetavad immuunsüsteemi (organismi loomulikke kaitsemehhanisme) kaitsma organismi haiguste eest.
The flu strains used to produce the vaccine was to depend on official recommendations for the annual flu season. 
Vaktsiini tootmiseks kasutatavad gripitüved sõltuvad iga-aastase gripihooaja ametlikest soovitustest.
Withdrawal of the marketing authorisation application for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted) EMA/CHMP/114709/2012 
Müügiloa taotluse tagasivõtmise teave Fluad Paediatric (gripivaktsiin, pinnaantigeen, inaktiveeritud, adjuveeritud) EMA/CHMP/114709/2012
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. 
Inimravimite komitee oli eriti mures hea kliinilise tava puuduliku järgimise pärast, mis tuli ilmsiks pärast põhiuuringus osalenud uurimiskeskuste inspekteerimist.
The 
Euroopa Liidu amet
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. 
10. veebruaril 2012 teatas Novartis Vaccines and Diagnostics ametlikult inimravimite komiteele oma soovist võtta tagasi vaktsiini Fluad Paediatric müügiloa taotlus.
The application was withdrawn after ‘day 180'. 
Taotluse menetlemine oli kestnud 180 päeva, kui ettevõte taotluse tagasi võttis.
The vaccine is the same as a vaccine that is authorised in several EU countries to prevent seasonal flu in the elderly population. 
Vaktsiin on sama, mis on mitmes ELi riigis heaks kiidetud hooajalise gripi ennetamiseks eakatel.
The vaccine contains an ‘adjuvant' to enhance the immune response. 
Vaktsiin sisaldab immuunvastuse tugevdamiseks adjuvanti.
Fluad Paediatric was expected to be used to prevent influenza in infants and children aged from six months to less than nine years. 
Fluad Paediatricut kavatseti kasutada gripi ennetamiseks 6 kuu kuni 9 aasta vanustel lastel.
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. 
Seetõttu oli inimravimite komitee müügiloa taotluse tagasivõtmise ajal arvamusel, et vaktsiinile ei saa anda müügiluba, sest ettevõte ei olnud komitee tõstatatud põhiprobleeme piisavalt käsitlenud.
When a person is given the vaccine, the immune system recognises the viral parts as ‘foreign' and makes antibodies against them. 
Kui inimesele manustatakse vaktsiini, peab immuunsüsteem viiruseosi võõraks ja tekitab nende vastu antikehi.
This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions. 
Inimravimite komitee oli juba hinnanud ettevõtte esitatud dokumente ja koostanud ettevõttele vastamiseks küsimused.
Withdrawal of the marketing authorisation application for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted) 
Müügiloa taotluse tagasivõtmise teave Fluad Paediatric (gripivaktsiin, pinnaantigeen, inaktiveeritud, adjuveeritud)
immune system will then be able to produce antibodies more quickly when it is exposed to the viruses again. 
Kui immuunsüsteem puutub viirustega hiljem uuesti kokku, tekivad antikehad kiiremini.
Fluad Paediatric is a vaccine to protect against seasonal influenza. 
Fluad Paediatric on hooajalise gripi vaktsiin.
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. 
Oma kirjas Euroopa Ravimiametile taotluse tagasivõtmise kohta teatas ettevõte, et tagasivõtmise alus on ettevõtte suutmatus käsitleda nõutavaks tähtajaks inimravimite komitee tõstatatud probleeme.
The company informed the CHMP that there are no consequences for people currently included in clinical trials using Fluad Paediatric. 
Ettevõte teatas inimravimite komiteele, et taotluse tagasivõtmine ei mõjuta Fluad Paediatricu kliinilistes uuringutes osalevaid patsiente.
It contains proteins from three inactivated influenza (flu) virus strains. 
See sisaldab kolme inaktiveeritud gripiviiruse tüve valke.
Fluad Paediatric contains proteins from three influenza virus strains. 
Fluad Paediatric sisaldab kolme inaktiveeritud gripiviiruse tüve valke.
After the CHMP had assessed the company's responses to the first round of questions, there were still some unresolved issues. 
Inimravimite komitee oli esialgsed vastused läbi vaadanud, kuid mõni küsimus oli veel lahendamata.
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. 
Tuginedes esitatud andmete analüüsile ja inimravimite komitee esitatud küsimustele antud vastustele, nägi komitee taotluse tagasivõtmise ajal põhjust ettevaatuseks.
How is Fluad Paediatric expected to work? 
Mis on Fluad Paediatricu eeldatav toime?
What was Fluad Paediatric expected to be used for? 
Milleks kavatseti Fluad Paediatricut kasutada?
This summary was last updated on 26/10/2011. 
Kokkuvõtte viimane uuendus: 26/10/2011.
The European Medicines Agency (EMA) will review additional information that will become available according to an agreed timetable and this summary will be updated as necessary. 
Euroopa Ravimiamet (EMA) vaatab läbi täiendavad andmed, mis saavad kättesaadavaks kokkulepitud ajakava kohaselt, ja vajaduse korral uuendab käesolevat kokkuvõtet.
This is acceptable because of the current political and epidemiological situation in Europe with regard to avian 
See on Euroopa praeguses linnugripiga seotud poliitilises ja epidemioloogilises olukorras vastuvõetav.
Because of the current epidemiological situation of avian influenza and the consequent threat to both human and animal health, the Committee recommended the granting of a Marketing Authorisation. 
Linnugripi praeguse epidemioloogilise olukorra ja sellest tuleneva ohu tõttu nii inimeste kui ka loomade tervisele soovitas komitee anda müügiloa.
The vaccine does not contain any ingredients that are likely to pose a risk for consumers of vaccinated 
Vaktsiin ei sisalda koostisaineid, mis võivad ohustada vaktsineeritud lindude tarbijaid.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part 
Kui soovite lisateavet veterinaarravimite komitee soovituste aluse kohta, lugege palun teadusliku arutelu kokkuvõtet (samuti Euroopa avaliku hindamisaruande osa).
Inactivated recombinant avian influenza virus 
Inaktiveeritud rekombinantne linnugripi viirus
The virus used for the vaccine is a recombinant virus. 
Vaktsiinis kasutatav viirus on rekombinantviirus.
No field trial is available for this target species. 
Selle sihtliigi kohta ei ole väliuuringuid korraldatud.
The vaccine was assessed in the context of an emergency situation which means that further studies with Poulvac FluFend H5N3 RG are still ongoing and will be assessed. 
Vaktsiini hinnati hädaolukorra tingimustes, mis tähendab, et Poulvac FluFend H5N3 RG-ga jätkuvad edasised uuringud, mida veel hinnatakse.
Laboratory studies were carried out looking at the safety of the vaccine after a single dose, an overdose and a repeated dose regimen. 
Laboriuuringutes uuriti vaktsiini ohutust pärast ühekordset annust, üleannustamist ja korduva annusega raviskeemi.
In the future, if the birds are exposed to the avian flu virus, their immune systems will be able to make those antibodies quicker and this will help them fight the disease. 
Kui lind puutub hiljem kokku linnugripiviirusega, suudab tema immuunsüsteem moodustada neid antikehasid kiiremini ja see aitab tal haigusega võidelda.
The benefit-risk balance may be found in module 6 of this 
Kasulikkuse ja riski vahelist tasakaalu kirjeldab käesoleva Euroopa avaliku hindamisaruande 6. moodul.