natgillin/translations-raw huggingface dataset:
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.
After the CHMP had assessed the company's responses to the first round of questions, there were still some unresolved issues. 
Potem ko je CHMP ocenil odgovore družbe na prva vprašanja, so nekatera vprašanja še vedno ostala nerešena.
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. 
Zato je CHMP v času umika vloge menil, da cepivo ne more biti odobreno, saj družba ni odpravila glavnih zadržkov Odbora.
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. 
Posebej je bil zaskrbljen zaradi pomanjkljivosti v dobri klinični praksi, ki so se pokazale po pregledu lokacij izvedbe glavne študije.
The children were given either Fluad Paediatric, another influenza vaccine (Agrippal or Influsplit) or a non-influenza vaccine (Menjugate or Encepur). 
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).
Withdrawal of the marketing authorisation application for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted) EMA/CHMP/114709/2012 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Fluad Paediatric (cepivo proti gripi, površinski antigen, inaktivirano, z adjuvansom) EMA/CHMP/114709/2012
It contains proteins from three inactivated influenza (flu) virus strains. 
Vsebuje beljakovine iz treh inaktiviranih sevov virusa influence (gripe).
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. 
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.
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. 
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je CHMP v času umika izrazil določene večje zadržke.
Fluad Paediatric is a vaccine to protect against seasonal influenza. 
Fluad Paediatric je cepivo za zaščito pred sezonsko gripo.
What is Fluad Paediatric? 
Kaj je zdravilo Fluad Paediatric?
Withdrawal of the marketing authorisation application for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted) 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Fluad Paediatric (cepivo proti gripi, površinski antigen, inaktivirano, z adjuvansom)
Fluad Paediatric contains proteins from three influenza virus strains. 
Zdravilo Fluad Paediatric vsebuje beljakovine iz treh sevov virusa gripe.
immune system will then be able to produce antibodies more quickly when it is exposed to the viruses again. 
izpostavljen virusu, bo lahko hitreje izdelal protitelesa.
What was Fluad Paediatric expected to be used for? 
Za kaj naj bi se zdravilo Fluad Paediatric uporabljalo?
How is Fluad Paediatric expected to work? 
Kako naj bi zdravilo Fluad Paediatric delovalo?
This summary was last updated on 26/10/2011. 
Povzetek je bil nazadnje posodobljen dne 26/10/2011.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part 
Če želite več informacij o podlagi za priporočila CVMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
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. 
Zaradi trenutne epidemiološke situacije v zvezi z aviarno influenco in posledične grožnje za zdravje ljudi in živali je odbor priporočil odobritev dovoljenja za promet.
This kind of ‘reassortment' between H and N types happens naturally in the wild but in this case has been carried out in the laboratory to produce a virus with these very specific properties. 
Ta vrsta »prerazporejanja« med tipoma H in N poteka v naravi spontano, v tem primeru pa je bila izvedena v laboratoriju z namenom, da bi izdelali virus s temi posebnimi lastnostmi.
The virus used for the vaccine is a recombinant virus. 
Virus, uporabljen za cepivo, je rekombinantni virus.
The benefit-risk balance may be found in module 6 of this 
Razmerje med koristmi in tveganji najdete v modulu 6 tega Evropskega javnega poročila o oceni
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. 
Upoštevali so tudi rezultate raziskav, izvedenih s podobnim cepivom na neokuženih piščancih (vsebujočim enake sestavine, z izjemo virusa).
Inactivated recombinant avian influenza virus 
Inaktivirani rekombinantni virus aviarne influence
The vaccine is injected intramuscularly (into the breast muscle) in chickens or subcutaneously (under the skin) in ducks, as two doses, 3 weeks apart. 
Cepivo se injicira intramuskularno (v prsno mišico) pri piščancih ali subkutano (pod kožo) pri racah v dveh odmerkih v razmaku 3 tednov.
Laboratory studies were carried out looking at the safety of the vaccine after a single dose, an overdose and a repeated dose regimen. 
Pri izvedenih laboratorijskih raziskavah so preučevali varnost cepiva po enem odmerku, po prevelikem odmerjanju in po režimu ponavljajočih se odmerkov.
In the future, if the birds are exposed to the avian flu virus, their immune systems will be able to make those antibodies quicker and this will help them fight the disease. 
Če bodo ptice v prihodnosti izpostavljene virusu aviarne influence, bo njihov imunski sistem ta protitelesa tvoril hitreje in to jim bo pomagalo v boju proti bolezni.
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. 
Evropska agencija za zdravila (EMA) bo pregledala dodatne informacije, ki bodo dane na razpolago glede na sprejet časovni načrt, in
It has been made using a ‘recombinant DNA technique' (when genes are inserted into an organism) to carry the H5 (haemagglutinin 5) and N3 (neuraminidase 3) antigens. 
Proizveden je bil z uporabo »rekombinantne DNK tehnologije« (pri tem se geni vstavijo v organizem) za prenašanje antigenov H5 (hemaglutinin 5) in N3 (nevraminidaza 3).
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. 
Ko ga ptice prejmejo, se imunski sistem teh živali (njihov naravni obrambni mehanizem) nauči tvoriti protitelesa (posebno vrsto beljakovine) za boj proti virusu.
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. 
Odbor za zdravila za uporabo v veterinarski medicini je sklenil, da je bila dokazana učinkovitost cepiva pri preprečevanju bolezni pri perutnini in je lahko uporaben pripomoček pri nadzorovanju izbruha okužbe z aviarno influenco.
The vaccine was assessed in the context of an emergency situation which means that further studies with Poulvac FluFend H5N3 RG are still ongoing and will be assessed. 
Cepivo je bilo ocenjeno v izrednih razmerah, kar pomeni, da nadaljnje raziskave z zdravilom Poulvac FluFend H5N3 RG še vedno potekajo in bodo ovrednotene v prihodnosti.
This strain has been chosen because it protects birds against the virulent H5N1 field strains (cross-protection), while allowing differentiation of vaccinated from infected birds. 
Ta sev je bil izbran, ker varuje ptice pred virulentnimi divjimi sevi H5N1 (navzkrižna zaščita), hkrati pa omogoča razlikovanje cepljenih ptic od okuženih ptic.
The vaccine does not contain any ingredients that are likely to pose a risk for consumers of vaccinated 
Cepivo ne vsebuje učinkovin, ki bi lahko predstavljale tveganje za ljudi, ki zaužijejo meso cepljenih
This is acceptable because of the current political and epidemiological situation in Europe with regard to avian 
Za to ciljno vrsto terenske študije niso na voljo, kar je sprejemljivo zaradi sedanje politične in epidemiološke situacije v Evropi glede aviarne influenze.
Birds vaccinated with this vaccine make antibodies against these two chosen antigens. 
Ptice, cepljene s tem cepivom, tvorijo protitelesa proti tema dvema izbranima antigenoma.
• The studies showed that the birds which receive the vaccine develop antibodies against the H5 subtype of the avian influenza virus. 
• Raziskave so pokazale, da ptice, ki prejmejo cepivo, tvorijo protitelesa proti virusu aviarne influence podtipa H5.
• The vaccine has been shown to prevent clinical signs and mortality and reduce virus shedding in infected chickens and ducks. 
• Dokazano je bilo, da cepivo preprečuje klinične znake in umrljivost ter zmanjšuje izločanje virusa pri okuženih piščancih in racah.
Poulvac FluFend H5N3 RG is a vaccine containing an inactivated avian influenza virus H5N3 (inactivated means that the virus has been killed so that it cannot cause the disease anymore). 
Zdravilo Poulvac FluFend H5N3 RG je cepivo, ki vsebuje inaktivirani antigen virus aviarne influence podtipa H5N3 (inaktiviran pomeni, da je bil virus ubit, zaradi česar ne more več povzročiti bolezni).
The person who gives the vaccine should be careful to avoid 
Oseba, ki daje cepivo, mora paziti, da si zdravila po nesreči ne samo
The European Commission granted a marketing authorisation valid throughout the European Union, for Poulvac FluFend H5N3 RG on 01.09.2006. 
Evropska Komisija je dovoljenje za promet z zdravilom Poulvac FluFend H5N3 RG, veljavno po vsej Evropski uniji, odobrila dne 01.09.2006.
Poulvac FluFend H5N3 RG is a vaccine used in chickens and ducks to protect against avian influenza. 
Zdravilo Poulvac FluFend H5N3 RG je cepivo, ki se uporablja pri piščancih in racah za zaščito pred aviarno influenco.
Vaccinated birds can be differentiated from infected birds by looking for antibodies against the N3 component. 
Cepljene ptice je mogoče razlikovati od okuženih ptic na podlagi protiteles proti sestavini N3.