natgillin/translations-raw huggingface dataset:
Dianeal PD4 (glEnglandoza 1,36%).
Dianeal PD4 (glukoza 1,36%).
Dianeal PD1 (glEnglandoza 3,86%).
Dianeal PD1 (glukoza 3,86%).
1,071 mg/ml arginin; 0,714 mg/ml histidin; 0,955 mg/ml lysin hydrochlorid; 1,02 mg/ml leucin; 0,85 mg/ml isoleucin; 0,85 mg/ml methionin; 1,393 mg/ml valin; 0,951 mg/ml alanin; 0,51 mg/ml glycin; 0,595 mg/ml prolin; 0,51 mg/ml serin; 0,646 mg/ml threonin; 0,57 mg/ml phenylalanin; 0,27 mg/ml tryptophan; 0,3 mg/ml tyrosin; 0,184 mg/ml calciumchlorid dihydrat; 0,051 mg/ml magnesiumchlorid hexahydrat; 5,38 mg/ml natriumchlorid; 4,48 mg/ml natriumlactat
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
Dianeal PD1 (glEnglandoza 1,36%).
Dianeal PD1 (glukoza 1,36%).
Extraneal (lcodextrin Peritonealdialysevæske icodextrin 75g/l; natriumchlorid 5,4 g/l; calciumchlorid 0,257 g/l; magnesiumchlorid 0,051 g/l; natrium-s-lactat 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
Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, ENGLAND
Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, UK
Natriumlactat 4,48 g/l Natriumchlorid 5,38 g/l Kvantitativ sammensætning af natriumlaktat
Sodium Chloride 5.38 g/l Quantitative Composition of Sodium Lactate Lactic Acid 139 g
0,955 g, L-Histidin Ph.Eur.
0.955 g, LHistidine Ph.Eur.
1,50 % w/v natriumclorid Ph.Eur.
1.50 % w/v Sodium Chloride Ph.Eur.
38,6 g/l glucose anhydrat
38,6 g/l glucose anhydrate
Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE England
Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE United Kingdom
L-Tyrosin 0,300 g/l L-Tryptofan 0,270 g/l L-Phenylalanin 0,570 g/l L-Threonin 0,646 g/l L-Serin 0,510 g/l L-Prolin 0,595 g/l Glycin 0,510 g/l L-Alanin 0,951 g/l L-Valin 1,393 g/l L-Methionin 0,850 g/l L-Isoleucin 0.850 g/l L-Leucin 1,020 g/l L-Lysin (chlorhydrat) 0,955 g/l L-Histidin 0,714 g/l L-Arginin 1,071 g/l Calciumchlorid dihydrat 0,184 g/l Magnesiumchlorid hexahydrat 0,051 g/l
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
England natriumchlorid 0,57% w/v; glucose 2,27 % w/v; magnesiumchlorid 0,015 % w/v; natriumlactat 0,39 % w/v; calciumchlorid 0,026 % 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
England Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE
Ireland Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE
4,25 % w/v natriumclorid Ph.Eur.
4.25 % w/v Sodium Chloride Ph.Eur.
Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Irland
Finland Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo
Glucose anhydrat 22,7 g/L, natriumchlorid 5,38 g/L, natriumL(+)-laktat 4,48 g/L, calciumchlorid dihydrat 0,184 g/L, magnesiumchlorid hexahydrat 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
13.6 g/l glucose anhydrat
13.6 g/l glucose anhydrate
Calciumchlorid: 0,026 % w/v; glucose 0,110 % w/v; natriumlaktat 0,336 % w/v; natriumchlorid 0,643 % w/v; magnesiumchlorid 0,015 % w/v
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
0,57 % w/v natriumlaktat Ph.Eur.
0.57 % w/v Sodium Lactate Ph.Eur.
magnesiumchlorid 0,015 % w/v; kaliumchlorid 0,029 % w/v; calciumchlorid 0,026 % w/v; natriumlaktat 0,336 % w/v; natriumchlorid 0,643 % w/v; glucose 0,110 % 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
Dianeal PD4 22,7 mg/ml glEnglandoze raztopina za peritonelano dializo
Dianeal PD4 22,7 mg/ml glukoze raztopina za peritonelano dializo
England magnesiumchlorid 0,005 % w/v; glucose 2,27 % w/v; natriumlactat 0,45 % w/v; calciumchlorid 0,018 % w/v; natriumchlorid 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
Nutrineal
Castlebar
Dianeal PD1 22,7 mg/ml glEnglandoze raztopina za peritonelano dializo
Dianeal PD1 22,7 mg/ml glukoze raztopina za peritonelano dializo
1,1 g / l 6,43 g / l 0,257 g / l 0,298 g / l 0,152 g / l 3,.36 g / l hæmodialysevæske hæmodialyse
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
Glucose anhydrat 38,6 g/L, natriumchlorid 5,38 g/L, natriumL(+)-laktat 4,48 g/L, calciumchlorid dihydrat 0,184 g/L, magnesiumchlorid hexahydrat 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
natriumchlorid 0,643 % w/v; magnesiumchlorid 0,015 % w/v; calciumchlorid 0,026 % w/v; glucose 0,110 % w/v; kaliumchlorid 0,015 % w/v; natriumlaktat 0,336 % 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
13,6 g/l glucose anhydrat
13,6 g/l glucose anhydrate
2,50 % w/v natriumchlorid Ph.Eur.
2.50 % w/v Sodium Chloride Ph.Eur.
Glucose anhydrat 13,6 g/L, natriumchlorid 5,38 g/L, natriumL(+)-laktat 4,48 g/L, calciumchlorid dihydrat 0,184 g/L, magnesiumchlorid hexahydrat 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
42,5 mg/ml Glucose monohydrat, 5,67 mg/ml natriumchlorid; 0,257 mg/ml calciumchlorid dihydrat; 0,152 mg/ml magnesiumchlorid hexahydrat; 3,92 mg/ml natriumlaktat
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 Glucose monohydrat, 5,38 mg/ml natriumchlorid; 0,184 mg/ml calciumchlorid dihydrat; 0,051 mg/ml magnesiumchlorid hexahydrat; 4,48 mg/ml natriumlaktat
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
15 mg/ml Glucose monohydrat, 5,38 mg/ml natriumchlorid; 0,184 mg/ml calciumchlorid dihydrat; 0,051 mg/ml magnesiumchlorid hexahydrat; 4,48 mg/ml natriumlaktat
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 Glucose monohydrat, 5,67 mg/ml natriumchlorid; 0,257 mg/ml calciumchlorid dihydrat; 0,152 mg/ml magnesiumchlorid hexahydrat; 3,92 mg/ml natriumlaktat
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
England magnesiumchlorid 0,005 % w/v; glucose 1,36 % w/v; natriumlactat 0,45 % w/v; calciumchlorid 0,018 % w/v; natriumchlorid 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
1,1 g / l 6,43 g / l 0,257 g / l 0,149 g / l 0,152 g / l 3,36 g / l hæmodialysevæske hæmodialyse
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
25 mg/ml Glucose monohydrat, 5,38 mg/ml natriumchlorid; 0,184 mg/ml calciumchlorid dihydrat; 0,051 mg/ml magnesiumchlorid hexahydrat; 4,48 mg/ml natriumlaktat
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
England magnesiumchlorid 0,015 % w/v; calciumchlorid 0,026 % w/v; glucose 3,86 % w/v; natriumlactat 0,39 % w/v; natriumchlorid 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
Dianeal PD4 38,6 mg/ml glEnglandoze raztopina za peritonelano dializo
Dianeal PD4 38,6 mg/ml glukoze raztopina za peritonelano dializo
25 mg/ml Glucose monohydrat, 5,67 mg/ml natriumchlorid; 0,257 mg/ml calciumchlorid dihydrat; 0,152 mg/ml magnesiumchlorid hexahydrat; 3,92 mg/ml natriumlaktat
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
1,1 g / l 6,43 g / l 0,257 g / l 0,152 g / l 3,36 g / l hæmodialysevæske hæmodialyse
1.1 g / l 6.43 g / l 0.257 g / l 0.152 g / l 3.36 g / l solution for haemodialysis hemodialysis
England magnesiumchlorid 0,005 % w/v; glucose 3,86 % w/v; natriumlactat 0,45 % w/v; calciumchlorid 0,018 % w/v; natriumchlorid 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 22,7 g + 5,38 g + 4,48 g + 0,184 g + 0,051 g/l
22,7g+5,38g+4,48g+0,184g+0,051g/l
England magnesiumchlorid 0,015 % w/v; calciumchlorid 0,026 % w/v; glucose 1,36 % w/v; natriumlactat 0,39 % w/v; natriumchlorid 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
Dianeal PD1 13,6 mg/ml glEnglandoze raztopina za peritonelano dializo
Dianeal PD1 13,6 mg/ml glukoze raztopina za peritonelano dializo
Dianeal PD1 38,6 mg/ml glEnglandoze raztopina za peritonelano dializo
Dianeal PD1 38,6 mg/ml glukoze raztopina za peritonelano dializo
Dianeal PD4 13,6 mg/ml glEnglandoze raztopina za peritonelano dializo
Dianeal PD4 13,6 mg/ml glukoze raztopina za peritonelano dializo
Dianeal PD4 Glucose 38,6 g + 5,38 g + 4,48 g + 0,184 g + 0,051 g/l
38,6g+5,38g+4,48g+0,184g+0,051g/l
1,36 % w/v 0,538 % w/v 0,448 % w/v
1,36% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v
Dianeal PD4 Glucose 38,6 mg/ml
Dianeal PD4 med glucos 38,6 mg/ml
Glucose monohydrat 1.1 g/L, natriumchlorid 6.43 g/L, natriumlactat 3.36 g/L, calciumchlorid dihydrat 0.257 g/L, magnesiumchlorid hexahydrat 0.152 g/L, kaliumchlorid 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
Dianeal PD4 Glucose 13,6 g + 5,38 g + 4,48 g + 0,184 g + 0,051 g/l
13,6g+5,38g+4,48g+0,184g+0,051g/l
Glucose monohydrat 1,1 g/L, natriumchlorid 6,43 g/L, natriumlaktat 3,36 g/L, calciumchlorid dihydrat 0,257 g/L, magnesiumchlorid hexahydrat 0,152 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
Glucose monohydrat 1.1 g/L, natriumchlorid 6.43 g/L, natriumlaktat 3.36 g/L, calciumchlorid dihydrat 0.257 g/L, magnesiumchlorid hexahydrat 0.152 g/L, kaliumchlorid 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
1,36 % w/v/13,6 mg/ml
1,36 % w/v / 13,6 mg/ml peritoneal use
Glucose monohydrat 1,1 g/l, natriumchlorid 6,43 g/l, calciumchlorid dihydrat 0,257 g/l, magnesiumchlorid hexahydrat 0,152 g/l, kaliumchlorid 0,149 g/l, natriumlaktat 3,36 g/l
Glucose Monohydrate 1.1 g/l, Sodium Chloride 6.43 g/l, Calcium Chloride Dihydrate 0.257 g/l, Magnesium Chloride Hexahydrate 0.152 g/l, Potassium Chloride 0.149 g/l, Sodium Lactate 3.36 g/l solution for haemodialysis/hae mofiltration intra-arterial use, intravenous use
Den 16. februar 2012
16 February 2012
Ansøgningen blev trukket tilbage efter "dag 180".
The application was withdrawn after ‘day 180'.
Virksomheden fremlagde desuden resultater af undersøgelser hos mennesker, herunder en hovedundersøgelse hos 4 902 børn.
The company also presented results of studies in humans, including one main study in 4,902 children.
Virksomheden fremlagde oplysninger om forsøgsmodeller fra tilsvarende vacciner.
The applicant presented data on experimental models from similar vaccines.
Andre vigtige betænkeligheder vedrørte utilstrækkelige oplysninger fra virksomheden, herunder oplysningerne om børn mellem seks og ni år og børn med helbredsproblemer samt om revaccination.
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.
Desuden var der betænkelighed ved mangler i de laboratorietest, der var anvendt til at fastslå, om patienterne havde influenza eller ikke.
There were also concerns about deficiencies in the laboratory tests used to confirm whether patients had influenza or not.
Den 10. februar 2012 meddelte Novartis Vaccines and Diagnostics officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Fluad Paediatric til forebyggelse af sæsonbetinget influenza hos spædbørn og børn.
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.
Virusset er blevet inaktiveret, så det ikke er sygdomsfremkaldende.
The viruses have first been inactivated so that they do not cause any disease.
Fluad Paediatric forventedes anvendt til forebyggelse af influenza hos spædbørn og børn fra seks måneder til under ni år.
Fluad Paediatric was expected to be used to prevent influenza in infants and children aged from six months to less than nine years.
Vaccinen er den samme som en vaccine, der i flere EU-lande er godkendt til forebyggelse af sæsonbetinget influenza hos den ældre del af befolkningen.
The vaccine is the same as a vaccine that is authorised in several EU countries to prevent seasonal flu in the elderly population.
Manglerne bestod i ukorrekte oplysninger i den dokumentation, der var indleveret til agenturet, hvilket i høj grad anfægtede troværdigheden af undersøgelsens resultater.
The shortcomings included incorrect data in the dossier submitted to the Agency, which greatly impacted the reliability of the study results.
Dette medvirker til at beskytte mod den sygdom, der forårsages af influenzavirusset.
This may help to protect against the disease caused by the influenza viruses.
ter vil immunsystemet fremover kunne danne antistoffer hurtigere, hvis det møder samme virus igen.
immune system will then be able to produce antibodies more quickly when it is exposed to the viruses again.
Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for personer, der på nuværende tidspunkt deltager i kliniske undersøgelser med Fluad Paediatric.
The company informed the CHMP that there are no consequences for people currently included in clinical trials using Fluad Paediatric.
På tilbagetrækningstidspunktet var det derfor CHMP's konklusion, at vaccinen ikke kunne godkendes, da virksomheden ikke havde imødekommet udvalgets vigtigste betænkeligheder.
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.
Børnene fik enten Fluad Paediatric, en anden influenzavaccine (Agrippal eller Influsplit) eller en vaccine, der ikke var en influenzavaccine (Menjugate eller Encepur).
The children were given either Fluad Paediatric, another influenza vaccine (Agrippal or Influsplit) or a non-influenza vaccine (Menjugate or Encepur).
Undersøgelsen skulle ifølge planen strække sig over tre influenzasæsoner og registrere antal influenzatilfælde i løbet af sæsonen efter vaccination.
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.
I sit brev til agenturet om tilbagetrækningen af ansøgningen, anfører virksomheden, at tilbagetrækningen skyldtes, at den ikke så sig i stand til at imødekomme CHMP's betænkeligheder inden for de fastsatte frister.
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.
Fluad Paediatric er en vaccine til beskyttelse mod sæsonbetinget influenza.
Fluad Paediatric is a vaccine to protect against seasonal influenza.
Efter at CHMP havde vurderet virksomhedens besvarelse af den første runde af spørgsmål, var der stadig nogle uafklarede punkter.
After the CHMP had assessed the company's responses to the first round of questions, there were still some unresolved issues.
Tilbagetrækning af ansøgningen om markedsføringstilladelse for Fluad Paediatric(influenzavaccine, overfladeantigen, inaktiveret, med adjuvans) EMA/CHMP/114709/2012
Withdrawal of the marketing authorisation application for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted) EMA/CHMP/114709/2012
Hvad er Fluad Paediatric?
What is Fluad Paediatric?
Når man får vaccinen, opfatter immunsystemet viruskomponenterne som "fremmede" og danner antistoffer mod dem. Deref
When a person is given the vaccine, the immune system recognises the viral parts as ‘foreign' and makes antibodies against them.
De stammer, der skulle anvendes til fremstilling af vaccinen, skulle vælges på grundlag af officielle anbefalinger vedrørende den årlige influenzasæson.
The flu strains used to produce the vaccine was to depend on official recommendations for the annual flu season.
Betænkelighederne gjaldt især de mangler vedrørende god klinisk praksis (GCP), der blev konstateret ved en inspektion på centrene, hvor hovedundersøgelsen fandt sted.
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.
Vaccinen indeholder et "adjuvans", dvs. et stof, der styrker immunreaktionen.
The vaccine contains an ‘adjuvant' to enhance the immune response.
Hvad forventedes Fluad Paediatric anvendt til?
What was Fluad Paediatric expected to be used for?
Den indeholder proteiner fra tre inaktiverede stammer af influenzavirus.
It contains proteins from three inactivated influenza (flu) virus strains.
På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål havde CHMP flere vigtige betænkeligheder på tidspunktet for tilbagetrækningen af ansøgningen.
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.
Tilbagetrækning af ansøgningen om markedsføringstilladelse for Fluad Paediatric (influenzavaccine, overfladeantigen, inaktiveret, med adjuvans)
Withdrawal of the marketing authorisation application for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted)
Fluad Paediatric indeholder proteiner fra tre stammer af influenzavirus.
Fluad Paediatric contains proteins from three influenza virus strains.
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Fluad Paediatric eller i programmer for anvendelse af Fluad Paediatric med særlig udleveringstilladelse?
What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Hvordan forventes Fluad Paediatric at virke?
How is Fluad Paediatric expected to work?
Dette sammendrag blev sidst ajourført den 26/10/2011.
This summary was last updated on 26/10/2011.
Dette er acceptabelt på baggrund af den nuværende politiske og epidemiologiske situation i Europa med hensyn til fugleinfluenza.
This is acceptable because of the current political and epidemiological situation in Europe with regard to avian
Det Europæiske Lægemiddelagentur (EMA) vil gennemgå alle nye oplysninger, der bliver til rådighed i henhold til den aftalte tidsplan, og vil ajourføre dette sammendrag efter behov.
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.
Inaktiveret rekombinant aviær influenza virus
Inactivated recombinant avian influenza virus
På baggrund af den aktuelle epidemiologiske situation med hensyn til fugleinfluenza og den heraf følgende trussel mod menneskers og dyrs sundhed anbefalede udvalget udstedelse af markedsføringstilladelse.
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.
Hvis du ønsker yderligere oplysninger om baggrunden for CVMP's anbefalinger, kan du læse den videnskabelige drøftelse (også en del af denne EPAR).
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part
Den virus, der anvendes til denne vaccine, er en rekombinant virus.
The virus used for the vaccine is a recombinant virus.
I lighed med mange andre vacciner med adjuvans (forstærkende hjælpestof) kan der på vaccinationsstedet forekomme hævelse, som kan vare i ca. 14 dage.
In common with many adjuvanted vaccines swelling may occur at the vaccination site which may last for about 14 days.
Desuden har man gennemgået resultaterne af undersøgelser af en tilsvarende vaccine hos kyllinger, der var fri for smitte (vaccinen indeholdt de samme stoffer, bortset fra virusen).
The results of studies of a similar vaccine on chickens free of any infection (containing the same ingredients, except for the virus) were also looked at.
Vaccinen indsprøjtes intramuskulært (i brystmusklen) på kyllinger og subkutant (under huden) på ænder og gives som to doser med tre ugers mellemrum.
The vaccine is injected intramuscularly (into the breast muscle) in chickens or subcutaneously (under the skin) in ducks, as two doses, 3 weeks apart.
Udvalget for Veterinærlægemidler (CVMP) konkluderede, at det er påvist, at vaccinen er sikker og effektiv til at forebygge sygdom hos fjerkræ, og at den kan være et nyttigt redskab til bekæmpelse af udbrud af fugleinfluenza.
The Committee for Medicinal Products for Veterinary Use concluded that the vaccine has been shown to be safe and to be effective in preventing disease in poultry and could be a useful tool in controlling an outbreak of avian influenza infection.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Poulvac FluFend H5N3 RG den 01.09.2006.
The European Commission granted a marketing authorisation valid throughout the European Union, for Poulvac FluFend H5N3 RG on 01.09.2006.
Når vaccinen gives til fugle, vil dyrenes immunsystem (deres naturlige forsvar) lære, hvordan det skal danne antistoffer (en særlig type proteiner) for at bekæmpe virusen.
When it is given to birds, the animals' immune systems (their natural defences) learn how to make antibodies (a special type of protein) to fight the virus.
Benefit/risk-forholdet er beskrevet i afsnit 6 i denne EPAR.
The benefit-risk balance may be found in module 6 of this