natgillin/translations-raw huggingface dataset:
Konečné verze souhrnu údajů o přípravku, označení na obalu a příbalových informací, které byly vytvořeny v průběhu postupu koordinační skupiny, jsou uvedeny v příloze III.
the CHMP has recommended the granting of the Marketing Authorisations for which the valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure are set out in Annex III for Sanohex and associated names (see Annex I).
- výbor CHMP usoudil, že vzhledem k průkazné bioekvivalenci na systémové úrovni (AUC a Cmax) má přípravek Sanohex shodný profil systémové bezpečnosti s referenčním léčivým přípravkem,
- the CHMP considered that Sanohex and the reference product possess the same systemic safety profile, as demonstrated by the bioequivalence in systemic levels (AUC and Cmax),
informace o cíli, velikosti částic potřebné k prokázání rovnocennosti v předem stanovených fázích v rámci předem stanoveného přijatelného rozmezí a předem stanovených šarží a statistických metod.
Question 1- The Applicant should provide the protocol of the in vitro comparisons of the particle size distributions in dry conditions, humid conditions and with spacer where all the relevant information should have been pre-specified, e.g. objective, sample size required to demonstrate equivalence in the predefined pools of stages within a pre-specified acceptance range, the pre-specified batches and the pre-specified statistical methods.
Smyšlený název Název
Invented name
Ph. Eur.
Eur.
Maďarsko Baxter Hungary Kft. Népfürdö u. 22.
Hungary Baxter Hungary Kft. Népfürdő u. 22.
Německo Baxter Deutschland GmbH Edisonstr.
Germany Baxter Deutschland GmbH Edisonstr.
Avenue louis Pasteur 78310 ZA de Coignieres 78310 Maurepas France
Avenue louis Pasteur ZA de Coignières Maurepas 78310 Maurepas France
Rumunsko BAXTER d.o.o.
Romania BAXTER d.o.o.
Piazzale dell'Industria 20 00144 Roma Italy
Baxter SPA piazzale dell' industria 20 - 00144 Roma, Italy
Seznam názvů léčivého (léčivých) přípravku(ů), léková(é) forma)y), koncentrace, způsob(y) podání, žadatel(é), držitel(é) rozhodnutí o registraci v členských státech
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Lucembursko Baxter SA Bd René Branquart 80 B-7860 Lessines Belgium
Luxembourg Baxter SA, Bd René Branquart 80, B-7860 Lessines Belgium
Eur., 0.257, Magnesii chloridum hexahydricum Ph. Eur.0.152, Natrii lactas Ph. Eur.
Eur., 0.257, Magnesium Chloride Hexahydrate Ph. Eur.0.152, Sodium Lactate Ph. Eur.
Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeis t of
Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeistof
7,5% (icodextrinum)
7,5% (icodextrin)
Portugalsko Baxter Médico Farmacêutica Lda
Baxter MédicoFarmacêutica, Lda.
Zelezna cesta 14, SI-1000 Ljubljana, Slovenia
Zelezna cesta 14, SI-1000 Ljubljana
Glucosum monohydricum Ph. Eur.1.1, Natrii chloridum Ph. Eur.
Glucose Monohydrate Ph. Eur.1.1, Sodium Chloride Ph. Eur.
11 g/l aminoacida a 1,25 mmol/l Ca.
11 g/l amino acids and 1,25 mmol/l Ca.
Valimotie 15A 00381 Helsinki Finland
Baxter Oy Valimotie 15 A 00381 Helsinki Finland
L thyrosinum Ph.Eur.
L-Tyrosine Ph.Eur.
Edificio 10 Sintra Business Park,
Zona Industrial da Abrunheira - Edifício 10Sintra Business Park, 2710-089 Sintra Portugal
Rakousko Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien
Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien Austria
75.00 g/l Icodextrinum
75.00 g/l Icodextrine
75 g/l Icodextrinum
75 g/l icodextrine
Členský stát Držitel rozhodnutí o registraci
Marketing authorisation holder
3.36, Kalii chloridum Ph. Eur.
3.36, Potassium Chloride Ph. Eur.
0.184 g, Magnesii chloridum hexahydricum Ph.Eur.
0.184 g, Magnesium chloride hexahydrate Ph.Eur.
Nizozemsko Baxter B.V Kobaltweg 49
Netherlands Baxter B.V., Kobaltweg 49, 3542 CE Utrecht
1.393g, Lmethioninum Ph.Eur.
1.393 g, LMethionine Ph.Eur.
Icodextrinum 7,5% w/v, Natrii chloridum Ph.Eur.
Icodextrin 7.5 % w/v, Sodium Chloride Ph.
6.43, Calcii chloridum dihydricum Ph.
6.43, Calcium Chloride Dihydrate Ph.
1.071 g, Calcii chloridum dihydricum Ph.Eur.
1.071 g, Calcium chloride dihydrate Ph.Eur.
0,54% w/v, natrii(s(-lactas 0,45% w/v, Calcii chloridum Ph.Eur.
0.54 % w/v, Sodium (S)-lactate 0.45 % w/v, Calcium Chloride Ph. Eur.
Abrunheira,
Thetford,
Glucosum Ph.Eur.
Anhydrous Glucose Ph.Eur.
0.595 g, Glycinum Ph.Eur.
0.595 g, Glycine Ph.Eur.
0.850 g,L-isoleucinum Ph.Eur.
0.850 g, L-Isoleucine Ph.Eur.
Baxter Oy P.O. Box 270 Valimotie 15A 00381 Helsinki Finland
Box 270 Valimotie 15A 00381
7,5 % 75g/1000 ml
7,5 % 75 g / 1000 ml peritoneal use
0.951 g, L-valinum Ph.Eur.
0.951 g, L-Valine Ph.Eur.
0.955 g, Lhistidinum Ph.Eur.
0.955 g, LHistidine Ph.Eur.
Baxter Healthcare SA Moneen Road Castlebar
Baxter Healthcare S.A. Moneen Road Castlebar
1,1% Aminoacida
1,1% amino acid
Baxter S.A.
BAXTER S.L.
0.051 g, Natrii lactas Ph.Eur.
0.051 g, Sodium-lactate Ph.Eur.
Slovinsko Baxter d.o.o., Zelezna cesta 18 ,Ljubljana, SI-1000, Slovenia
Slovenia Baxter d.o.o., Zelezna cesta 18 , Ljubljana, SI-1000, Slovenia
Nutrineal PD4 with 1.1% Amino Acids tyrosinum 0.03%w/v; tryptophanum 0.027%w/v; phenylalaninum 0.057%w/v; threoninum 0.064%w/v; L-serinum 0.051%w/v; L-prolinum 0.058%w/v; glycinum 0.051%w/v; L-alaninum 0.095%w/v; valinum 0.139%w/v; methioninum 0.085%w/v; isoleucinum 0.085%w/v; leucinum 0.102%w/v; lysinum 0.095%w/v; histidinum 0/071%w/v; argininum 0.107%w/v; calcii chloridum 0.018%w/v; magnesii chloridum 0.005%w/v; natrii chloridum 0.538%w/v; natrii s lactas 0.448%w/v
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
0,538% w/v, Natrii lactas Ph.Eur.
0.538 % w/v Sodium Lactate Ph.Eur.
1.020g, L-lisini hydrochloridum Ph.Eur.
1.020 g, LLysine hydrochloride Ph.Eur.
4.480 g, Natrii chloridum Ph.Eur.
4.480 g, Sodium chloride Ph. Eur.
0.270g, Lphenylalaninum Ph.Eur.
0.270 g, L-Phenylalanine Ph.Eur.
0.510g, L- alaninum Ph.Eur.
0.510 g, L-Alanine Ph.Eur.
75 mg/ml icodextrinum, 5,4 mg/ml natrii chloridum, , 4,5 mg/ml natrii (S) lactas solutio, 0,051 mg/ml magnesii chloridum , 0,257 mg/ml calcii chloridum
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
0.510 g, L-prolinum Ph.Eur.
0.510 g, L-Proline Ph.Eur.
Bulharsko BAXTER d.o.o.,Zelezna cesta 18, 1000 Ljubljana, Slovenia
BAXTER d.o.o.,Zelezna cesta 18, 1000 Ljubljana Slovenia
Baxter Healthcare S.A. Moneen Road Castlebar, CO. Mayo lreland
Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland
L thyrosinum Ph.Eur.0.300 g, Ltryptophanum Ph. Eur.0.270g, Lphenylalaninum Ph.Eur.0.570 g, LthreoninumPh.Eur.
L-Tyrosine 0.300 g/l L-Tryptophan 0.270 g/l L-Phenylalanine 0.570 g/l L-Threonine 0.646 g/l L-Serine 0.510 g/l
0,57% w/v, Natrii lactas Ph.Eur.
0.57 % w/v Sodium Lactate Ph.Eur.
0,39% w/v, Calcii chloridum Ph.Eur.
0.39 % w/v Calcium Chloride Ph.Eur.
Icodextrinum (75g/l), Natrii chloridum (5.5g/l), Calcii chloridum (0.257 g/l), Magnesii chloridum (0.051 g/l), Natrii lactas solution (4,54 g/l)
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)
Španělsko Baxter S.L Pouet de Camilo, 2
Pouet de Camilo 2
Baxter Healthcare Ltd Caxton Way,
Baxter Healthcare Ltd., Caxton Way, Thetford,
5.380 g Kvantitativní složení Natrii lactas lactic acidum 139g Sodium hydrtoxide 52.25 g, Voda na injekci do 100 ml
Sodium Hydroxide 52.25 g Water for Injections to 100 ml
3,86% w(/v nebo Glucosum monohydricum Ph.Eur.
3.86 % w/v or Glucose Monohydrate Ph.Eur.
0,0,0184% w/v, Magnesii chloridum Ph.Eur.
0.0184 % w/v Magnesium Chloride Ph.Eur.
0,448% w/v, Calcii chloridum Ph.Eur.
0.448 % w/v Calcium Chloride Ph.Eur.
22.7 g/l glucosum
22,7 g/l glucose anhydrate
Estonsko Baxter Oy P.O. Box 270
Lithuania Baxter Oy, P.O.
0.300 g, Ltryptophanum Ph. Eur.
0.300 g, L-Tryptophan Ph.Eur.
38.6 g/l glucosum
38.6 g/l glucose anhydrate
0,0257% w/v, Magnesii chloridum Ph.Eur.
0.0257 % w/v Magnesium Chloride Ph.Eur.
Nutrineal PD4 mit 1,1 % AminosäurenPeritonealdialyselösung alaninum 951 mg/l, argininum 1071 mg/l, glycinum 510 mg/l, histidinum 714 mg/l, isoleucinum 850 mg/l leucinum 1020 mg/l, lysini hydrochloridum 955 mg/l,methioninum 850 mg/l, phenilalaninum 570 mg/l, prolinum 595 mg/l, serinum 510 mg/l, threoninum 646 mg/l, tryptophanum 270 mg/l, tyrosinum 300 mg/l, valinum 1393 mg/l, natrii chloridum 5380 mg/l, calcii chloridum dihydricum 184 mg/l, magnesii chloridum hexahydricum 51 mg/l, Natrii s-lactas 4480 mg/L
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
1,36% w(/v nebo Glucosum monohydricum Ph.Eur.
1.36 % w/v or Glucose Monohydrate Ph.Eur.
Zona Industrial da
Route of administration
2,27% w(/v nebo Glucosum monohydricum Ph.Eur.
2.27 % w/v or Glucose Monohydrate Ph.Eur.
0.646 g, Lserinum Ph.Eur.
0.646 g, L-Serine Ph.Eur.
0.714 g, Largininum Ph.Eur.
0.714 g L-Arginine Ph.Eur.
Dianeal PD4 Glucose 2.27% w/v /22.7mg/ml magnesii chloridum 0,005% w/v, calcii chloridum 0,018% w/v, glucosum 2,27% w/v, natrii lactas 0,45% w/v, natrii chloridum 0,54 w/v
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 PD1 Glucose 3.86% w/v /38.6mg/ml magnesii chloridum 0,015% w/v, calcii chloridum 0,026% w/v, glucosum 3,86% w/v, natrii lactas 0,39% w/v, natrii chloridum 0,57 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
2.27%w/v 3.86%w/v
1.36% W/V 2,27% W/V 3,86% W/V
13.6 g/l glucosum
13.6 g/l glucose anhydrate
Dianeal PD4 Glucose 3.86% w/v /38.6mg/ml magnesii chloridum 0,005% w/v, calcii chloridum 0,018% w/v, glucosum 3,86% w/v, natrii lactas 0,45% w/v, natrii chloridum 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 PD1 Glucose 1.36% w/v /13.6mg/ml magnesii chloridum 0,015% w/v, calcii chloridum 0,026% w/v, glucosum 1,36% w/v, natrii lactas 0,39% w/v, natrii chloridum 0,57 w/v
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
0.570 g, Lthreoninum Ph.Eur.
0.570 g, L-Threonine Ph.Eur.
4,25% w/v, Natrii chloridum Ph.Eur.
4.25 % w/v Sodium Chloride Ph.Eur.
Dianeal PD4 Glucose 1.36% w/v /13.6mg/ml magnesii chloridum 0,005% w/v, calcii chloridum 0,018% w/v, glucosum 1,36% w/v, natrii lactas 0,45% w/v, natrii chloridum 0,54 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 PD1 Glucose 2.27% w/v /22.7mg/ml magnesii chloridum 0,015% w/v, calcii chloridum 0,026% w/v, glucosum 2,27% w/v, natrii lactas 0,39% w/v, natrii chloridum 0,57 w/v
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%/22,7 mg/ml, peritoneaaldialysevloeis t of
Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeistof
1,071 mg/ml argininum, 0,714 mg/ml histidinum, 0,955 mg/ml lisini hydrochloridum, 1,02 mg/ml leucinum, 0,85 mg/ml isoleucinum, 0,85 mg/ml methioninum, 1,393 mg/ml valinum,0,951 mg/ml alaninum, 0,51 mg/ml glycinum, 0,595 mg/ml prolinum, 0,51 mg/ml serinum, 0,646 mg/ml threoninum, 0,57 mg/ml phenylalaninum, 0,27 mg/ml tryptophanum, 0,3 mg/ml tyrosinum, 0,184 mg/ml calcium chloridum dihydricum, 0,051 mg/ml magnesii chloridum hexahydricum, 5,38 mg/ml natrii chloridum, 4,48 mg/ml natrii lactas
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
Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland
Finland Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo
Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of
Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeistof
Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis t of
Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeistof
1,071 mg/ml argininum, 0,714 mg/ml histidinum, 0,955 mg/ml lisini hydrochloridum, 1,02 mg/ml leucinum, 0,85 mg/ml isoleucinum, 0,85 mg/ml methioninum, 1,393 mg/ml valinum,0,951 mg/ml alaninum, 0,51 mg/ml glycinum, 0,595 mg/ml prolinum, 0,51 mg/ml serinum, 0,646 mg/ml threoninum, 0,57 mg/ml phenylalaninum, 0,27 mg/ml tryptophanum, 0,3 mg/ml tyrosinum, 0,184 mg/ml calcium chloridum dihydricum, 0,051 mg/ml magnesii chloridum hexahydricum, 5,38 mg/ml natrii chloridum, 4,48
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;
1,50% w/v, Natrii chloridum Ph.Eur.
1.50 % w/v Sodium Chloride Ph.Eur.
Glucosum monohydricum 1.1 g/l, natrii chloridum 6.43 g/l, natrii lactas 3.36 g/l, calcii chloridum dihydricum 0.257 g/l, magnesii chloridum hexahydricum 0.152 g/l, Potassii chloridum 0.298 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 0.298 g/L
0.850 g, Lleucinum Ph.Eur.
0.850 g, L-Leucine Ph.Eur.
Velká Británie Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE
Ireland Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE
Glucosum monohydricum 1.1 g/l, natrii chloridum 6.43 g/l, natrii lactas 3.36 g/l, calcii chloridum dihydricum 0.257 g/l, magnesii chloridum hexahydricum 0.152 g/l, Potassii chloridum 0.149 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
Baxter S.A.S
Baxter SAS
Glucosum 22.7 g/l, Natrii chloridum 5.38 g/l, Natrii l-lactas 4.48 g/l, Calcii chloridum dihydricum 0,184 g/l, Magnesii chloridum hexahydricum 0,051 g/l
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
Solución para diálisis peritoneal
solution for dialysis peritoneal
Kalii chloridum 0.029%w/v; calcii chloridum 0.026% w/v, glucosum 0.110%w/v; natrii lactas 0.336%w/v; natrii chloridum 0.643%w/v; magnesii chloridum 0.015%w/v
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
Glucosum 38.6 g/l, Natrii Chloridum 5.38 g/l, Natrii-s-lactas 4.48 g/l, Calcii chloridum dihydricum 0,184 g/l, Magnesii chloridum hexahydricum 0,051 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
2,50% w/v, Natrii chloridum Ph.Eur.
2.50 % w/v Sodium Chloride Ph.Eur.
Glucosum13.6 g/l,Natrii chloridum 5.38 g/l, Natrii l-lactas 4.48 g/l, Calcii chloridum dihydricum 0,184 g/l, Magnesii chloridum hexahydricum 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
Kalii chloridum Ph. Eur.
1.1, Sodium Chloride Ph. Eur.
Roztok pro hemodialýzu, hemodiafiltraci a hemofiltraci hemodialýza
solution for haemodialysis, haemodiafiltration and haemofiltration hemodialysis
0.257 g/l, Magnesii chloridum hexahydricum
0.257, Magnesium Chloride Hexahydrate Ph. Eur.
Dianeal PD4 Glucose 22,7 mg/ml
Dianeal PD4 med glucos 22,7 mg/ml
42,5 mg/ml glucosum monohydricum, 5,38 mg/ml natrii chloridum, 0,184 mg/ml calcii chloridum dihydricum, 0,051 mg/ml magnesii chloridum hexahydricum, 4,48 mg/ml natrii lactas
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
0.110%w/v; natrii lactas 0.336%w/v; natrii chloridum 0.643%w/v; magnesii chloridum 0.015%w/v, kalii chloridum
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
15 mg/ml glucosum monohydricum, 5,38 mg/ml natrii chloridum, 0,184 mg/ml calcii chloridum dihydricum, 0,051 mg/ml magnesii chloridum hexahydricum, 4,48 mg/ml natrii lactas
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
42,5 mg/ml glucosum monohydricum, 5,67 mg/ml natrii chloridum, 0,257 mg/ml calcii chloridum dihydricum, 0,152 mg/ml magnesii chloridum hexahydricum, 3,92 mg/ml natrii lactas
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
25 mg/ml glucosum monohydricum, 5,38 mg/ml natrii chloridum, 0,184 mg/ml calcii chloridum dihydricum, 0,051 mg/ml magnesii chloridum hexahydricum, 4,48 mg/ml natrii lactas
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
Icodextrinum 75g/l, natrii chloridum 5,4 g/l, calcii chloridum 0,257 g/l, magnesii chloridum 0,051 g/l, natrii s-lactas 4,5 g/l
Extraneal (Icodextrin 7.5%) Solution for peritoneal dialysis icodextrin 75g/l; sodium chloride 5.4g/l; calcium chloride 0,257g/l; magnesium chloride 0.051g/l; sodium s-lactate 4.5g/l
25 mg/ml glucosum monohydricum, 5,67 mg/ml natrii chloridum, 0,257 mg/ml calcii chloridum dihydricum, 0,152 mg/ml magnesii chloridum hexahydricum, 3,92 mg/ml natrii lactas
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
15 mg/ml glucosum monohydricum, 5,67 mg/ml natrii chloridum, 0,257 mg/ml calcii chloridum dihydricum, 0,152 mg/ml magnesii chloridum hexahydricum, 3,92 mg/ml natrii lactas
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
1,36% w/v/13,6 mg/ml
1,36 % w/v / 13,6 mg/ml peritoneal use
Nutrineal PD4+A.A.1,1
Nutrineal PD4+A.A.1,1% 1,1% amino acids
0.595 g, Glycinum Ph.Eur.0.510g, L- alaninum Ph.Eur.0.951 g, L-valinum Ph.Eur.1.393g, L-methioninum Ph.Eur.
L-Alanine 0.951 g/l L-Valine 1.393 g/l
16. února 2012
16 February 2012
Žádost byla stažena po „180.
The application was withdrawn after ‘day 180'.
Společnost také předložila výsledky studií na lidech, včetně jedné hlavní studie na 4 902 dětech.
The company also presented results of studies in humans, including one main study in 4,902 children.
Viry byly nejprve inaktivovány, aby nemohly vyvolat onemocnění.
The viruses have first been inactivated so that they do not cause any disease.
Žadatel předložil údaje z experimentálních modelů u podobných vakcín.
The applicant presented data on experimental models from similar vaccines.
Dopis se stažením žádosti je k dispozici zde.
The withdrawal letter is available here.
Další závažné obavy souvisely s nedostatečností údajů, které společnost poskytla, včetně údajů týkajících se dětí ve věku od 6 do 9 let, dětí se zdravotními problémy a údajů o revakcinaci.
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.
Vakcína obsahuje „adjuvans“ pro zlepšení imunitní reakce.
The vaccine contains an ‘adjuvant' to enhance the immune response.
Nedostatky zahrnovaly nepřesné údaje v dokumentaci předložené agentuře, což značně ovlivnilo spolehlivost výsledků studie.
The shortcomings included incorrect data in the dossier submitted to the Agency, which greatly impacted the reliability of the study results.
Objevily se také obavy týkající se pochybení v laboratorních testech používaných k potvrzení, zda pacient trpí či netrpí chřipkou.
There were also concerns about deficiencies in the laboratory tests used to confirm whether patients had influenza or not.
Znamená to, že výbor CHMP posoudil dokumentaci předloženou společností a vypracoval seznamy otázek.
This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Dne 10. února 2012 společnost Novartis Vaccines and Diagnostics oficiálně oznámila Výboru pro humánní léčivé přípravky (CHMP), že se rozhodla stáhnout svou žádost o vydání rozhodnutí o registraci přípravku Fluad Paediatric určeného k prevenci sezonní chřipky u kojenců a dětí.
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.
Přípravek Fluad Paediatric měl být používán k prevenci chřipky u kojenců a dětí ve věku od 6 měsíců do 9 let.
Fluad Paediatric was expected to be used to prevent influenza in infants and children aged from six months to less than nine years.
Co je Fluad Paediatric?
What is Fluad Paediatric?
Studie byla navržena tak, že probíhala přes tři chřipková období a zkoumala počty případů chřipky, které se objevily v období následujícím po očkování.
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.
Dětem byla podávána buď vakcína Fluad Paediatric, jiná vakcína proti chřipce (Agrippal nebo Influsplit) nebo vakcína proti jinému onemocnění než chřipce (Menjugate nebo Encepur).
The children were given either Fluad Paediatric, another influenza vaccine (Agrippal or Influsplit) or a non-influenza vaccine (Menjugate or Encepur).
Vakcína je totožná s vakcínou, která je registrována v několika zemích Evropské unie k prevenci sezonní chřipky u starší populace.
The vaccine is the same as a vaccine that is authorised in several EU countries to prevent seasonal flu in the elderly population.
Po podání vakcíny pacientovi rozpozná imunitní systém části viru jako „cizí“ a vytváří proti nim protilátky.
When a person is given the vaccine, the immune system recognises the viral parts as ‘foreign' and makes antibodies against them.