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
Slovenian: 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, natrijev klorid 5380 mg/L, kalcijev klorid 184 mg/L, magnezijev klorid 51 mg/L, natrijev S laktat 4480 mg/L
English: Baxter Healthcare Ltd., Caxton Way, Thetford,
Slovenian: Baxter Healthcare Ltd Caxton Way,
English: Route of administration
Slovenian: Zona Industrial da
English: 1.393 g, LMethionine Ph.Eur.
Slovenian: 1.393 g, L-Metionin Ph.Eur.
English: 38,6 g/l glucose anhydrate
Slovenian: 38.6 g/l Brezvodna glukoza
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
Slovenian: 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: 0.57 % w/v Sodium Lactate Ph.Eur.
Slovenian: 0.57 % w/v Natrijev laktat Ph.Eur.
English: 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
Slovenian: 75 mg/ml Ikodekstrin; 5,4 mg/ml natrijev klorid; 4,5 mg/ml raztopina natrijevega (S) - laktata; 0,051 mg/ml magnezijev klorid; 0,257 mg/ml kalcijev klorid
English: DIOPHAR S.A.
Slovenian: Baxter S.A.
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
Slovenian: L-Tirozin 0.300 g/l L-Triptofan 0.270 g/l L-Fenilalanin 0.570 g/l L-Treonin 0.646 g/l L-Serin 0.510 g/l L-Prolin 0.595 g/l Glicin 0.510 g/l L-Alanin 0.951 g/l L-Valin 1.393 g/l L-Metionin 0.850 g/l L-Izolevcin 0.850 g/l L-Levcin 1.020 g/l L-Lizin (klorohidrat) 0.955 g/l L-Histidin 0.714 g/l L-Arginin 1.071 g/l Kalcijev klorid dihidrat 0.184 g/l Magnezijev klorid heksahidrat 0.051 g/l
English: 13,6 g/l glucose anhydrate
Slovenian: 13.6 g/l Brezvodna glukoza
English: 1,1% acides aminés
Slovenian: 1,1% aminokisline
English: 00381 Finland
Slovenian: 0484 Oslo
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
Slovenian: 1,071 mg/ml Arginin; 0,714 mg/ml Histin; 0,955 mg/ml Lizin hidriklorid; 1,02 mg/ml levcin; 0,85 mg/ml izolevcin; 0,85 mg/ml metionin; 1,393 mg/ml Valin; 0,951 mg/ml Alanin; 0,51 mg/ml Glicin; 0,595 mg/ml Prolin; 0,51 mg/ml Serin; 0,646 mg/ml Treonin; 0,57 mg/ml fenilalanin; 0,27 mg/ml Triptofan; 0,3 mg/ml tirozin; 0,184 mg/ml kalcijev klorid dihidrat; 0,051 mg/ml magnezijev klorid heksahidrat; 5,38 mg/ml natrijev klorid; 4,48 mg/ml natrijev laktat
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
Slovenian: Natrijev klorid 0.57%w/v; glukoza 2.27%w/v; magnezijev klorid 0.015%w/v; natrijev laktat 0.39%w/v; kalcijev klorid 0.026%w/v
English: 0.510 g, L-Alanine Ph.Eur.
Slovenian: 0.510 g, LAlanin Ph.Eur.
English: 42.50 g/l; 5.38 g/l; 4.48 g/l; 0.184 g/l; 0.051 g/l
Slovenian: 42.50 g/l; 5.38 g/l; 4.48 g/l; 0.184 g/l;
English: Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeistof
Slovenian: Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis tof
English: Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeistof
Slovenian: Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis tof
English: Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeistof
Slovenian: Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis tof
English: Finland Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo
Slovenian: Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland
English: Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeistof
Slovenian: Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis tof
English: Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeistof
Slovenian: Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis tof
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)
Slovenian: Kslcijev klorid (0.257 g/l), Magnezijev klorid (0.051 g/l), raztopina natrijevega laktata (4.5 g/l)
English: Sodium Chloride 5.38 g/l Quantitative Composition of Sodium Lactate Lactic Acid 139 g
Slovenian: Natrijev laktat 4.48 g/l Natrijev klorid 5.38 g/l Kvantitativna sestava natrijevega laktata:
English: 15.0 g/l; 5.38 g/l; 4.48 g/l; 0.184 g/l; 0.051 g/l
Slovenian: 15.0 g/l; 5.38 g/l; 4.48 g/l; 0.184 g/l;
English: Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeistof
Slovenian: Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis tof
English: 0.300 g, L-Tryptophan Ph.Eur.
Slovenian: 0.300 g, LTriptofan 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
Slovenian: Magnezijev klorid 0.005%w/v; glukoza 2.27%w/v; natrijev laktat 0.45%w/v; kalcijev klorid 0.018%w/v; natrijev klorid 0.54%w/v
English: 22,7g+5,38g+4,48g+0,184g+0,051g/l
Slovenian: Dianeal PD4 Glucose 22,7g+5,38g+4,48g+0,184g+0,051 g/l
English: 0.570 g, L-Threonine Ph.Eur.
Slovenian: 0.570 g, LTreonin Ph.Eur.
English: 3,86% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v
Slovenian: 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
Slovenian: 25.0 g/l; 5.38 g/l; 4.48 g/l; 0.184 g/l;
English: 1,36% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v
Slovenian: 1,36% w/v 0,538% w/v 0,448% w/v
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
Slovenian: Brezvodna glukoza 22.7 g/L, natrijev klorid 5.38 g/L, natrijev S laktat 4.48 g/L, kalcijev klorid 0,184 g/L, magnezijev klorid 0,051 g/L
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
Slovenian: Magnezijev klorid 0.015%w/v; kalcijev klorid 0.026%w/v; glukoza 1.36%w/v; natrijev laktat 0.39%w/v; natrijev klorid 0.57%w/v
English: solution for dialysis peritoneal
Slovenian: Solución para diálisis peritoneal
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
Slovenian: 42,5 mg/ml glukoza monohidrat; 5,67 mg/ml natrijev klorid; 0.257 mg/ml kalcijev klorid dihidrat; 0,152 mg/ml magnezijev klorid heksahidrat; 3,92 mg/ml natrijev laktat
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
Slovenian: 42,5 mg/ml glukoza monohidrat; 5,38 mg/ml natrijev klorid; 0,184 mg/ml kalcijev klorid dihidrat; 0,051 mg/ml magnezijev klorid heksahidrat; 4,48 mg/ml natrijev laktat
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
Slovenian: Magnezijev klorid 0.015%w/v; kalcijev klorid 0.026%w/v; glukoza 3.86%w/v; natrijev laktat 0.39%w/v; natrijev klorid 0.57%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
Slovenian: Magnezijev klorid 0.005%w/v; glukoza 1.36%w/v; natrijev laktat 0.45%w/v; kalcijev klorid 0.018%w/v; natrijev klorid 0.54%w/v
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
Slovenian: Brezvodna glukoza 38.6 g/L, natrijev klorid 5.38 g/L, natrijev S laktat 4.48 g/L, kalcijev klorid 0,184 g/L, magnezijev klorid 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
Slovenian: 15 mg/ml glukoza monohidrat; 5,38 mg/ml natrijev klorid; 0,184 mg/ml kalcijev klorid dihidrat; 0,051 mg/ml magnezijev klorid heksahidrat; 4,48 mg/ml natrijev laktat
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
Slovenian: Magnezijev klorid 0.005%w/v; glukoza 3.86%w/v; natrijev laktat 0.45%w/v; kalcijev klorid 0.018%w/v; natrijev klorid 0.54%w/v
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
Slovenian: 15 mg/ml glukoza monohidrat; 5,67 mg/ml natrijev klorid; 0,257 mg/ml kalcijev klorid dihidrat; 0,152 mg/ml magnezijev klorid heksahidrat; 3,92 mg/ml natrijev laktat
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
Slovenian: Brezvodna glukoza 13.6 g/L, natrijev klorid 5.38 g/L, natrijev S laktat 4.48 g/L, kalcijev klorid 0,184 g/L, magnezijev klorid 0,051 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
Slovenian: 25 mg/ml glukoza monohidrat; 5,38 mg/ml natrijev klorid; 0,184 mg/ml kalcijev klorid dihidrat; 0,051 mg/ml magnezijev klorid heksahidrat; 4,48 mg/ml natrijev laktat
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
Slovenian: 25 mg/ml glukoza monohidrat; 5,67 mg/ml natrijev klorid; 0,257 mg/ml kalcijev klorid dihidrat; 0,152 mg/ml magnezijev klorid heksahidrat; 3,92 mg/ml natrijev laktat
English: 38,6g+5,38g+4,48g+0,184g+0,051g/l
Slovenian: Dianeal PD4 Glucose 38,6g+5,38g+4,48g+0,184g+0,051 g/l
English: 42.50 g/l; 5.67 g/l; 3.92 g/l; 0.257 g/l; 0.152 g/l
Slovenian: 42.50 g/l; 5.67 g/l; 3.92 g/l; 0.257 g/l;
English: Dianeal PD4 med glucos 13,6 mg/ml
Slovenian: Dianeal PD4 Glucose 13,6 mg/ml
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
Slovenian: 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: 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
Slovenian: Glukoza monohidrat 1.1 g/L, Natrijev klorid 6.43 g/L, Natrijev laktat 3.36 g/L, Kalcijev klorid dihidrat 0.257 g/L, Magnezijev klorid heksahidrat 0.152 g/L, Kalijev klorid 0.298 g/L
English: 13,6g+5,38g+4,48g+0,184g+0,051g/l
Slovenian: 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
Slovenian: 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: 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
Slovenian: Glukoza monohidrat 1.1 g/L, Natrijev klorid 6.43 g/L, Natrijev laktat 3.36 g/L, Kalcijev klorid dihidrat 0.257 g/L, Magnezijev klorid heksahidrat 0.152 g/L
English: Ireland Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
Slovenian: Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom
English: solution for haemodialysis, haemodiafiltration and haemofiltration hemodialysis
Slovenian: Raztopina za hemodilaizo, hemodiafiltracijo in hemofiltracijo hemodializa
English: 25.0 g/l; 5.67 g/l; 3.92 g/l; 0.257 g/l; 0.152 g/l
Slovenian: 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 0.149 g/L
Slovenian: Glukoza monohidrat 1.1 g/L, Natrijev klorid 6.43 g/L, Natrijev laktat 3.36 g/L, Kalcijev klorid dihidrat 0.257 g/L, Magnezijev klorid heksahidrat 0.152 g/L, Kalijev klorid 0.149 g/L
English: Dianeal PD4 med glucos 38,6 mg/ml
Slovenian: Dianeal PD4 Glucose 38,6 mg/ml
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
Slovenian: Monosol glukoza 0.110%w/v; natrijev laktat 0.336%w/v; natrijev klorid 0.643%w/v; kalcijev klorid 0.026% w/v; magnezijev klorid 0.015%w/v
English: 4.48 g/ l
Slovenian: 184 mg/l; 51
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
Slovenian: 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: 1.1 g / l 6.43 g / l 0.257 g / l 0.152 g / l 3.36 g / l solution for haemodialysis hemodialysis
Slovenian: 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
Slovenian: 1,36% w/v/13,6 mg/ml
English: Nutrineal PD4+A.A.1,1% 1,1% amino acids
Slovenian: Nutrineal PD4+A.A.1,1
English: 16 February 2012
Slovenian: 16. februar 2012
English: The application was withdrawn after ‘day 180'.
Slovenian: Vlogo so umaknili po „180.
English: The viruses have first been inactivated so that they do not cause any disease.
Slovenian: Virusi si bili najprej inaktivirani, tako da ne morejo povzročiti bolezni.
English: The company also presented results of studies in humans, including one main study in 4,902 children.
Slovenian: Družba je predstavila tudi rezultate študij na ljudeh, vključno z glavno študijo, ki je vključevala 4 902 otroka.
English: The applicant presented data on experimental models from similar vaccines.
Slovenian: Predlagatelj je predstavil podatke poskusnih modelov za podobna cepiva.
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.
Slovenian: Drugi glavni zadržki so bili povezani z nezadostnimi podatki, ki jih je podala družba, vključno s podatki o otrocih med šestim in devetim letom, otrocih z zdravstvenimi težavami in o ponovnem cepljenju.
English: This may help to protect against the disease caused by the influenza viruses.
Slovenian: To lahko prispeva k obrambi pred boleznijo, ki jo povzročajo virusi gripe.
English: The vaccine contains an ‘adjuvant' to enhance the immune response.
Slovenian: Cepivo vsebuje „adjuvans“ za povečanje imunskega odziva.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Slovenian: To pomeni, da je CHMP ocenil dokumentacijo, ki jo je družba predložila, in oblikoval seznam vprašanj.
English: Fluad Paediatric was expected to be used to prevent influenza in infants and children aged from six months to less than nine years.
Slovenian: Zdravilo Fluad Paediatric naj bi se uporabljalo za preprečevanje gripe pri dojenčkih in otrocih, starih od šest mesecev do manj kot devet let.
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.
Slovenian: Družba Novartis Vaccines and Diagnostics je dne 10. februarja 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Fluad Paediatric, namenjenim preprečevanju sezonske gripe pri dojenčkih in otrocih.
English: The shortcomings included incorrect data in the dossier submitted to the Agency, which greatly impacted the reliability of the study results.
Slovenian: Med pomanjkljivostmi so bile nepravilnosti v podatkih v dokumentaciji, ki je bila predložena agenciji, kar je bistveno vplivalo na zanesljivost rezultatov študije.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Slovenian: Cepiva delujejo tako, da imunski sistem (naravno obrambo telesa) „naučijo“, kako naj se brani pred boleznijo.
English: There were also concerns about deficiencies in the laboratory tests used to confirm whether patients had influenza or not.
Slovenian: Odbor je imel pomisleke tudi v zvezi s pomanjkanjem laboratorijskih preiskav, ki so se uporabljali za potrditev, ali so bolniki imeli gripo ali ne.
English: The vaccine is the same as a vaccine that is authorised in several EU countries to prevent seasonal flu in the elderly population.
Slovenian: To cepivo je enako cepivu, ki je odobreno v več državah EU za preprečevanje sezonske gripe pri starejši populaciji.
English: The
Slovenian: dnevu“.
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.
Slovenian: Študija je bila zasnovana tako, da je potekala v obdobju treh sezon gripe in je proučevala število primerov gripe, ki so se pojavile v sezoni po cepljenju.
English: The company informed the CHMP that there are no consequences for people currently included in clinical trials using Fluad Paediatric.
Slovenian: Družba je CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih z uporabo zdravila Fluad Paediatric.
English: The flu strains used to produce the vaccine was to depend on official recommendations for the annual flu season.
Slovenian: Sevi virusa gripe, uporabljeni za izdelavo cepiva, naj bi bili odvisni od uradnih priporočil za letno sezono gripe.
English: When a person is given the vaccine, the immune system recognises the viral parts as ‘foreign' and makes antibodies against them.
Slovenian: Ko oseba prejme cepivo, imunski sistem prepozna dele virusa kot „tujke“ in začne proti njim tvoriti protitelesa.
English: After the CHMP had assessed the company's responses to the first round of questions, there were still some unresolved issues.
Slovenian: Potem ko je CHMP ocenil odgovore družbe na prva vprašanja, so nekatera vprašanja še vedno ostala nerešena.
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.
Slovenian: Zato je CHMP v času umika vloge menil, da cepivo ne more biti odobreno, saj družba ni odpravila glavnih zadržkov Odbora.
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.
Slovenian: Posebej je bil zaskrbljen zaradi pomanjkljivosti v dobri klinični praksi, ki so se pokazale po pregledu lokacij izvedbe glavne študije.
English: The children were given either Fluad Paediatric, another influenza vaccine (Agrippal or Influsplit) or a non-influenza vaccine (Menjugate or Encepur).
Slovenian: Otroci so prejeli bodisi zdravilo Fluad Paediatric, drugo cepivo proti gripi (Agrippal ali Influsplit) ali pa cepivo, ki ni namenjeno preprečevanju gripe (Menjugate ali Encepur).
English: Withdrawal of the marketing authorisation application for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted) EMA/CHMP/114709/2012
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Fluad Paediatric (cepivo proti gripi, površinski antigen, inaktivirano, z adjuvansom) EMA/CHMP/114709/2012
English: It contains proteins from three inactivated influenza (flu) virus strains.
Slovenian: Vsebuje beljakovine iz treh inaktiviranih sevov virusa influence (gripe).
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.
Slovenian: Agencija je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da njen umik temelji na dejstvu, da ne more odpraviti zadržkov odbora CHMP v zahtevanem roku.
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.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je CHMP v času umika izrazil določene večje zadržke.
English: Fluad Paediatric is a vaccine to protect against seasonal influenza.
Slovenian: Fluad Paediatric je cepivo za zaščito pred sezonsko gripo.
English: What is Fluad Paediatric?
Slovenian: Kaj je zdravilo Fluad Paediatric?
English: Withdrawal of the marketing authorisation application for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Fluad Paediatric (cepivo proti gripi, površinski antigen, inaktivirano, z adjuvansom)
English: Fluad Paediatric contains proteins from three influenza virus strains.
Slovenian: Zdravilo Fluad Paediatric vsebuje beljakovine iz treh sevov virusa gripe.
English: immune system will then be able to produce antibodies more quickly when it is exposed to the viruses again.
Slovenian: izpostavljen virusu, bo lahko hitreje izdelal protitelesa.
English: What was Fluad Paediatric expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Fluad Paediatric uporabljalo?
English: How is Fluad Paediatric expected to work?
Slovenian: Kako naj bi zdravilo Fluad Paediatric delovalo?
English: This summary was last updated on 26/10/2011.
Slovenian: Povzetek je bil nazadnje posodobljen dne 26/10/2011.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part
Slovenian: Če želite več informacij o podlagi za priporočila CVMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
English: 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.
Slovenian: Zaradi trenutne epidemiološke situacije v zvezi z aviarno influenco in posledične grožnje za zdravje ljudi in živali je odbor priporočil odobritev dovoljenja za promet.