natgillin/translations-raw huggingface dataset:
The CHMP did not agree that this amount of drug is too small to be relevant and could furthermore not support the Applicant claim that stage 1 is related only to safety.
Odbor CHMP se ni strinjal s tem, da je količina zdravila premajhna, dabi veljala kot pomembna, poleg tega pa ni mogel podpreti trditve predlagatelja, da je 1. stopnja povezana samo z varnostjo.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
DODATEK I ZOZNAM NÁZVOV, FARMACEUTICKÝCH FORIEM, MNOŽSTVÁ ÚČINNÝCH LÁTOK V LIEKOCH, SPÔSOB PODÁVANIA, UCHÁDZAČI, V ČLENSKÝCH ŠTÁTOCH
The marketing applications were submitted as hybrid applications under Article 10(3) of Directive 2001/83/EC and the EU reference product is Sultanol Dosier-Aerosol 100 μg/dose, Druckgasinhalation, suspension, (GlaxoSmithKline).
Vloge za dovoljenje za promet z zdravilom so bile predložene v obliki hibridnih vlog v skladu s členom 10(3) Direktive 2001/83/ES, referenčno zdravilo v EU pa je Sultanol Dosier-Aerosol 100 μg/odmerek, inhalacijska raztopina pod tlakom, suspenzija, (GlaxoSmithKline).
The Applicant also decided to generate additional spacer data in order to obtain more reliable information on the particle size distribution when the compared inhalers are fitted with their respective spacer devices.
Predlagatelj se je odločil tudi za pridobivanje dodatnih podatkov o podaljšku, da bi pridobil zanesljivejše informacije o porazdelitvi velikosti delcev, kadar so primerjani inhalatorji opremljeni s pripadajočimi podaljševalnimi pripomočki.
The CHMP was of the opinion that the bioequivalence study (2207-59-DOS-5) demonstrated equivalency in safety profile when used without a spacer, as well as similar Cmax and Tmax values.
Odbor CHMP je menil, da je študija biološke enakovrednosti (2207-59-DOS-5) dokazala enakovrednost varnostnega profila pri uporabi brez podaljška ter podobne vrednosti Cmax in Tmax.
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).
je CHMP priporočil odobritev dovoljenj za promet z zdravilom, katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so končne različice, oblikovane med postopkom usklajevalne skupine in navedene v Dodatku III za zdravilo Sanohex in z njim povezana imena (glejte Dodatek I).
The new formal protocol of the performed retrospective analysis and the new final report on the in vitro data indicated that the 90% CI remained outside the 15% or 20% acceptance range for stage 0, stage 1 and stage 2 and within the 20% CI but outside the 15% CI for stage 3 the 90% CI.
Novi formalni protokol izvedene retrospektivne analize in novo končno poročilo o in vitro podatkih sta pokazala, da je 90-odstotni interval zaupanja ostal zunaj 15- ali 20-odstotnega razpona sprejemljivosti za 0., 1. in 2. stopnjo in znotraj 20odstotnega intervala zaupanja, vendar zunaj 15-odstotnega intervala zaupanja za 3. stopnjo 90
Sanohex is a metered dose aerosol inhaler containing a suspension formulation of salbutamol sulphate 100 µg/spray, with HFA 134a as propellant.
Zdravilo Sanohex je aerosolni inhalator z določenim odmerkom, ki vsebuje formulacijo suspenzije salbutamol sulfata 100 µg/pršilo s hidrofluoroalkanom 134a kot pogonskim plinom.
- 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),
- CHMP je menil, da imata zdravilo Sanohex in referenčno zdravilo enak profil sistemske varnosti, kot je bilo dokazano z biološko enakovrednostjo na sistemskih ravneh (AUC in Cmax),
The pharmacokinetic bioequivalence data also confirmed that Sanohex and the reference product possess the same systemic safety profile since bioequivalence in systemic levels (AUC and Cmax) have been shown, when used with or without a spacer.
Farmakokinetični podatki o biološki enakovrednosti so prav tako potrdili, da imata zdravilo Sanohex in referenčno zdravilo, ob uporabi podaljška ali brez njega, enak profil sistemske varnosti, saj je bila dokazana biološka enakovrednost na sistemskih ravneh (AUC in Cmax).
Member State EU/EEA
Država članica
Pressurised inhalation, suspension
100 µg/odmerek Inhalacijska suspenzija pod tlakom
Hungary Baxter Hungary Kft. Népfürdő u. 22.
Madžarska Baxter Hungary Kft. Népfürdö u. 22.
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, predlagateljev, imetnikov dovoljenja za promet z zdravilom v državah članicah
Romania BAXTER d.o.o.
Romunija BAXTER d.o.o.
11 g/l amino acids and 1,25 mmol/l Ca.
11 g/l aminokisline and 1,25 mmol/l Ca.
L-Tyrosine Ph.Eur.
L-Tirozin Ph.Eur.
Sodium Hydroxide 52.25 g Water for Injections to 100 ml
Laktična kislina 139 g Natrijev hidroksid 52.25 g Voda za injekcije do 100 ml
4.480 g, Sodium chloride Ph. Eur.
4.480 g, Natrijev klorid Ph. Eur.
Baxter MédicoFarmacêutica, Lda.
Portugalska Baxter Médico Farmacêutica Lda
Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeistof
Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeis tof
Baxter AS Gjerdrumsvei 11 0484 Oslo Norway
0484 Oslo, Norway
7,5% (icodextrin)
7,5% (ikodekstrin)
0.54 % w/v, Sodium (S)-lactate 0.45 % w/v, Calcium Chloride Ph. Eur.
0.54 % w/v, Natrijev (S)-laktat 0.45 % w/v, Kalcijev klorid Ph. Eur.
0.714 g L-Arginine Ph.Eur.
0.714 g L-Arginin Ph.Eur.
0.0257 % w/v, Magnesium Chloride Ph. Eur.
0.0257 % w/v, Magnezijev klorid Ph. Eur.
solution for haemodialysis, haemodiafiltration and haemofiltration intraarterial use, intravenous use, hemodialysis
Raztopina za hemodilaizo, hemodiafiltracijo in hemofiltracijo za intraarterijsko uporabo, za intravenozno uporabo, hemodializa
1.071 g, Calcium chloride dihydrate Ph.Eur.
1.071 g, Kalcijev klorid dihidrat Ph.Eur.
Anhydrous Glucose Ph.Eur.
Brezvodna glukoza Ph.Eur.
Netherlands Baxter B.V., Kobaltweg 49, 3542 CE Utrecht
Nizozemska Baxter B.V Kobaltweg 49
75.00 g/l Icodextrine
75.00 g/l Ikodekstrin
0.646 g, L-Serine Ph.Eur.
0.646 g, L-Serin Ph.Eur.
0.184 g, Magnesium chloride hexahydrate Ph.Eur.
0.184 g, Magnezijev klorid heksahidrat Ph.Eur.
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
Extraneal (lcodextrin 7.5%) Solution for peritoneal dialysis ikodekstrin 75g/l; natrijev klorid 5.4g/l; kalcijev klorid 0,257g/l; magnezijev klorid 0.051g/l; natrijev-s-laktat 4.5g/l
0.951 g, L-Valine Ph.Eur.
0.951 g, L-Valin Ph.Eur.
75 g/l icodextrine
75 g/l ikodekstrin
0.850 g, L-Leucine Ph.Eur.
0.850 g, L-Leucin Ph.Eur.
Icodextrin 7.5 % w/v, Sodium Chloride Ph.
Ikodekstrin 7.5 % w/v, Natrijev klorid Ph. Eur.
0.955 g, LHistidine Ph.Eur.
0.955 g, LHistidin Ph.Eur.
Slovenia Baxter d.o.o., Zelezna cesta 18 , Ljubljana, SI-1000, Slovenia
Slovenija Baxter d.o.o., Zelezna cesta 18 ,Ljubljana, SI-1000, Slovenia
0.448 % w/v Calcium Chloride Ph.Eur.
0.448 % w/v Kalcijev klorid Ph.Eur.
0.39 % w/v Calcium Chloride Ph.Eur.
0.39 % w/v Kalcijev klorid Ph.Eur.
1.020 g, LLysine hydrochloride Ph.Eur.
1.020 g, L-lizin hidroklorid Ph.Eur.
0.510 g, L-Proline Ph.Eur.
0.510 g, L-Prolin Ph.Eur.
0.850 g, L-Isoleucine Ph.Eur.
0.850 g, L-Izoleucin Ph.Eur.
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
Nutrineal PD4 with 1.1% Amino Acids tyrosin 0.03%w/v; triptofan 0.027%w/v; fenilalanin 0.057%w/v; treonin 0.064%w/v; L-serin 0.051%w/v; L-prolin 0.058%w/v; glicin 0.051%w/v; L-alanin 0.095%w/v; valin 0.139%w/v; metionin 0.085%w/v; izolevcin 0.085%w/v; levcin 0.102%w/v; lizin 0.095%w/v; histidin 0/071%w/v; arginin 0.107%w/v; kalcijev klorid 0.018%w/v; magnezijev klorid 0.005%w/v; natrijev klorid 0.538%w/v; natrijev-s-laktat 0.448%w/v
3.86 % w/v or Glucose Monohydrate Ph.Eur.
3.86 % w/v ali glukoza monohidrat Ph.Eur.
0.538 % w/v Sodium Lactate Ph.Eur.
0.538 % w/v Natrijev laktat Ph.Eur.
2.27 % w/v or Glucose Monohydrate Ph.Eur.
2.27 % w/v ali glukoza monohidrat Ph.Eur.
0.595 g, Glycine Ph.Eur.
0.595 g, Glicin Ph.Eur.
22,7 g/l glucose anhydrate
22.7 g/l Brezvodna glukoza
0.270 g, L-Phenylalanine Ph.Eur.
0.270 g, LFenilalanin Ph.Eur.
1.36 % w/v or Glucose Monohydrate Ph.Eur.
1.36 % w/v ali glukoza monohidrat Ph.Eur.
0.051 g, Sodium-lactate Ph.Eur.
0.051 g, Natrijev laktat Ph.Eur.
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 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
1.393 g, LMethionine Ph.Eur.
1.393 g, L-Metionin Ph.Eur.
38,6 g/l glucose anhydrate
38.6 g/l Brezvodna glukoza
0.57 % w/v Sodium Lactate Ph.Eur.
0.57 % w/v Natrijev laktat 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 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
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-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
13,6 g/l glucose anhydrate
13.6 g/l Brezvodna glukoza
1,1% acides aminés
1,1% aminokisline
00381 Finland
0484 Oslo
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
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
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
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
0.510 g, L-Alanine Ph.Eur.
0.510 g, LAlanin Ph.Eur.
Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeistof
Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis tof
Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeistof
Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis tof
Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeistof
Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis tof
Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeistof
Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis tof
Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeistof
Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis tof
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)
Kslcijev klorid (0.257 g/l), Magnezijev klorid (0.051 g/l), raztopina natrijevega laktata (4.5 g/l)
Sodium Chloride 5.38 g/l Quantitative Composition of Sodium Lactate Lactic Acid 139 g
Natrijev laktat 4.48 g/l Natrijev klorid 5.38 g/l Kvantitativna sestava natrijevega laktata:
Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeistof
Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis tof
0.300 g, L-Tryptophan Ph.Eur.
0.300 g, LTriptofan 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
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
0.570 g, L-Threonine Ph.Eur.
0.570 g, LTreonin Ph.Eur.
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
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
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
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
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 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
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 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
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
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
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
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
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
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
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 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
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
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
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 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
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
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
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 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
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 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
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
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
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
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
solution for haemodialysis, haemodiafiltration and haemofiltration hemodialysis
Raztopina za hemodilaizo, hemodiafiltracijo in hemofiltracijo hemodializa
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
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
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
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
4.48 g/ l
184 mg/l; 51
16 February 2012
16. februar 2012
The application was withdrawn after ‘day 180'.
Vlogo so umaknili po „180.
The viruses have first been inactivated so that they do not cause any disease.
Virusi si bili najprej inaktivirani, tako da ne morejo povzročiti bolezni.
The company also presented results of studies in humans, including one main study in 4,902 children.
Družba je predstavila tudi rezultate študij na ljudeh, vključno z glavno študijo, ki je vključevala 4 902 otroka.
The applicant presented data on experimental models from similar vaccines.
Predlagatelj je predstavil podatke poskusnih modelov za podobna cepiva.
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.
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.
This may help to protect against the disease caused by the influenza viruses.
To lahko prispeva k obrambi pred boleznijo, ki jo povzročajo virusi gripe.
The vaccine contains an ‘adjuvant' to enhance the immune response.
Cepivo vsebuje „adjuvans“ za povečanje imunskega odziva.
This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
To pomeni, da je CHMP ocenil dokumentacijo, ki jo je družba predložila, in oblikoval seznam vprašanj.
Fluad Paediatric was expected to be used to prevent influenza in infants and children aged from six months to less than nine years.
Zdravilo Fluad Paediatric naj bi se uporabljalo za preprečevanje gripe pri dojenčkih in otrocih, starih od šest mesecev do manj kot devet let.
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.
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.
The shortcomings included incorrect data in the dossier submitted to the Agency, which greatly impacted the reliability of the study results.
Med pomanjkljivostmi so bile nepravilnosti v podatkih v dokumentaciji, ki je bila predložena agenciji, kar je bistveno vplivalo na zanesljivost rezultatov študije.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Cepiva delujejo tako, da imunski sistem (naravno obrambo telesa) „naučijo“, kako naj se brani pred boleznijo.
There were also concerns about deficiencies in the laboratory tests used to confirm whether patients had influenza or not.
Odbor je imel pomisleke tudi v zvezi s pomanjkanjem laboratorijskih preiskav, ki so se uporabljali za potrditev, ali so bolniki imeli gripo ali ne.
The vaccine is the same as a vaccine that is authorised in several EU countries to prevent seasonal flu in the elderly population.
To cepivo je enako cepivu, ki je odobreno v več državah EU za preprečevanje sezonske gripe pri starejši populaciji.
The
dnevu“.
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.
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.
The company informed the CHMP that there are no consequences for people currently included in clinical trials using Fluad Paediatric.
Družba je CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih z uporabo zdravila Fluad Paediatric.
The flu strains used to produce the vaccine was to depend on official recommendations for the annual flu season.
Sevi virusa gripe, uporabljeni za izdelavo cepiva, naj bi bili odvisni od uradnih priporočil za letno sezono gripe.
When a person is given the vaccine, the immune system recognises the viral parts as ‘foreign' and makes antibodies against them.
Ko oseba prejme cepivo, imunski sistem prepozna dele virusa kot „tujke“ in začne proti njim tvoriti protitelesa.