natgillin/translations-raw huggingface dataset:
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Vepacel. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Vepacel, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The most common side effects with Vepacel (seen in more than 1 person in 10) in adults are headache, fatigue (tiredness) and pain at the site of injection. 
Najpogostejši neželeni učinki cepiva Vepacel (opaženi pri več kot 1 osebi od 10) pri odraslih so glavobol, utrujenost in bolečina na mestu injiciranja.
Vaccination with Vepacel in adults produced an antibody response that met these criteria. 
Cepljenje z zdravilom Vepacel pri odraslih je izzvalo odziv protiteles, ki izpolnjuje ta merila.
The first main study involved 561 healthy adults, while the second study involved around 3,600 adults including those at higher risk of flu (such as people with a long-term illness or a weakened immune system). 
V prvo glavno študijo je bilo vključenih 561 zdravih odraslih ljudi, medtem ko je v drugi študiji sodelovalo okoli 3 600 odraslih, vključno s tistimi, pri katerih obstaja velika nevarnost, da se okužijo z gripo (kot so na primer osebe s kroničnimi boleznimi ali oslabelim imunskim sistemom).
According to criteria laid down by the CHMP, a prepandemic vaccine needs to bring about protective levels of antibodies in at least 70% of adults for it to be considered suitable. 
V skladu z merili, ki jih je določil CHMP, je prepandemično cepivo ustrezno učinkovito le, če zagotovi zaščitno raven protiteles pri vsaj 70 % odraslih oseb.
The use of Vepacel was later extended to children from 6 months of age since the vaccine was shown to produce a good antibody response also in this population, with a safety profile similar to that seen in adults. 
Uporaba cepiva Vepacel je bila kasneje razširjena na uporabo pri otrocih od 6 meseca starosti dalje, saj je bilo ugotovljeno, da cepivo tudi pri tej populaciji zagotavlja dober odziv protiteles s podobnim varnostnim profilom, kot je bil opažen pri odraslih osebah.
The Committee noted that Vepacel produced a good antibody response in healthy adults and an acceptable response in healthy adults aged 60 and over and in patients with a weakened immune system or long-term illness. 
Menil je, da je cepivo Vepacel izzvalo dober odziv, kar zadeva tvorjenje protiteles pri zdravih odraslih osebah, ter sprejemljiv odziv pri zdravih osebah, starih 60 let ali več, in bolnikih z oslabljenim imunskim sistemom ali kronično boleznijo.
This may help to provide protection in the event of a pandemic caused by a new strain of the H5N1 virus. 
To bi lahko pripomoglo k zagotovitvi zaščite v primeru pandemije, ki bi jo povzročil nov sev virusa H5N1.
All of the studies looked at the ability of the vaccine to trigger the production of antibodies (‘immunogenicity') against H5N1. 
V vseh študijah so proučevali sposobnost cepiva, da sproži nastajanje protiteles („imunogenost“) proti virusu H5N1.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vepacel, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu z njim so bile v povzetek glavnih značilnosti zdravila Vepacel in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The viruses used in Vepacel are grown in mammal cells (‘vero cells'), as opposed to hen's eggs. 
Virusi, uporabljeni pri cepivu Vepacel, so vzgojeni v celicah sesalcev (celicah vero) in ne v kokošjih jajcih.
Why has Vepacel been approved? 
Zakaj je bilo zdravilo Vepacel odobreno?
The study in children showed that vaccination with Vepacel brought about similar levels of antibodies to those seen in adults: at 21 days after the second injection, 85.4% of children aged 9 to 17 years, 72.9% of children aged 3 to 8 years and 68.8% of children aged 6 to 35 months had levels of antibodies that would protect them against H5N1. 
Študija, izvedena pri otrocih, je pokazala, da cepljenje s cepivom Vepacel vzpostavi podobne ravni protiteles kot pri odraslih: na 21. dan po drugem injiciranju, je bila pri 85,4 % otrok, starih od 9 do 17 let, 72,9 % otrok, starih od 3 do 8 let, in 68,8 % otrok, starih od 6 do 35 mesecev, vzpostavljena raven protiteles, ki bi jih lahko zaščitila proti virusu H5N1.
The booster vaccination (one year after the 2-dose vaccination with Vepacel) also produced a strong antibody response against the strains used in the booster and in Vepacel. 
Tudi poživitveno cepljenje (leto dni po cepljenju z drugim odmerkom cepiva Vepacel) je izzvalo močan odziv protiteles zoper seve, uporabljene v poživitvenem cepivu in cepivu Vepacel.
Health experts are concerned that a future flu pandemic could be caused by a strain of the H5N1 virus. 
Zdravstvene strokovnjake skrbi, da bi lahko naslednjo pandemijo gripe povzročil sev virusa H5N1.
This vaccine contains a strain of the H5N1 virus. 
To cepivo vsebuje sev virusa H5N1.
Vepacel is a vaccine for use in adults and children from 6 months of age to protect against flu caused by the H5N1 (“bird flu”) subtype of the influenza A virus. 
Zdravilo Vepacel je cepivo, ki se uporablja za cepljenje odraslih in otrok, starejših od 6 mesecev, za zaščito proti gripi, ki jo povzroča podtip H5N1 virusa gripe A („ptičja gripa“).
In both studies, participants were given two doses of Vepacel followed by a booster dose (given after six months, one year or two years) of a vaccine containing different strengths of the same H5N1 flu strain as in Vepacel or a different H5N1 flu strain. 
V obeh študijah so preiskovanci prejeli dva odmerka cepiva Vepacel, ki jima je sledil poživitveni odmerek (po šestih mesecih, enem letu ali dveh letih) cepiva, ki je vsebovalo druge jakosti istega seva virusa H5N1 kot v cepivu Vepacel ali drug sev virusa H5N1.
Vepacel has also been studied in a main study involving 657 healthy children aged 6 months to 17 years, who were given two doses of Vepacel, three weeks apart. 
Cepivo Vepacel so prav tako proučevali v glavni študiji, ki je zajela 657 zdravih otrok, starih od 6 mesecev do 17 let, katerim so dali dva odmerka cepiva Vepacel s tritedenskim razmikom med obema odmerkoma.
Vepacel is a vaccine. 
Zdravilo Vepacel je cepivo.
Influenza vaccine (whole virion, inactivated) 
Povzetek EPAR za javnost cepivo proti gripi (s celimi virioni, inaktivirano)
For the full list of all side effects reported with Vepacel, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Vepacel, glejte navodilo za uporabo.
In the first main study, at 21 days after the second injection, 72.5% of adults under 60 and 74.1% of adults aged 60 and over had levels of antibodies that would protect them against H5N1. 
V prvi glavni študiji je imelo 21 dni po drugem injiciranju 72,5 % odraslih oseb, mlajših od 60 let, in 74,1 % odraslih oseb, starih 60 let ali več, tako raven protiteles, ki bi jih lahko zaščitila pred virusom H5N1.
What is Vepacel used for? 
Za kaj se zdravilo Vepacel uporablja?
In the second main study, 85.8% of healthy adults under 60 and 80.2% of healthy adults aged 60 and over had protective levels of antibodies. 
V drugi glavni študiji se je zaščitna raven protiteles vzpostavila pri 85,8 % zdravih odraslih oseb, mlajših od 60 let, in 80,2 % zdravih odraslih oseb, starih 60 let ali več.
In both studies, patients who received Vepacel and a booster with a different H5N1 flu strain produced antibodies that could react with several strains of H5N1 virus. 
V obeh študijah so se pri bolnikih, ki so bili cepljeni s cepivom Vepacel in so prejeli poživitveni odmerek drugega seva virusa H5N1, pojavila protitelesa, ki bi lahko reagirala z več sevi virusa H5N1.
The Committee also noted that Vepacel produced a reasonable antibody response against other H5N1 strains that could potentially cause a flu pandemic. 
Prav tako je ugotovil, da je cepivo Vepacel izzvalo soliden odziv protiteles proti sevom virusa H5N1, ki bi lahko morda povzročili pandemijo gripe.
A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world. 
Pandemija gripe nastopi, ko se pojavi nov sev virusa gripe, ki se med ljudmi hitro širi, ker proti njemu niso imuni
How is Vepacel used? 
Kako se zdravilo Vepacel uporablja?
The vaccine has been developed so that it can be used before or during a flu pandemic to provide protection against the H5N1 virus. 
Cepivo je bilo razvito za zagotavljanje zaščite pred virusom H5N1, tako da ga je mogoče uporabiti pred pandemijo gripe ali med njo.
What is Vepacel? 
Kaj je zdravilo Vepacel?
Some children also received a booster dose of a vaccine containing a different H5N1 flu strain after one year. 
Nekateri od teh otrok so po enem letu prejeli še poživitveni odmerek cepiva, ki je vseboval drug sev virusa H5N1.
How has Vepacel been studied? 
Kako je bilo zdravilo Vepacel raziskano?
How does Vepacel work? 
Kako zdravilo Vepacel deluje?
During the previous inspection (January 2014) a number of major deficiencies were already identified. 
Med predhodnim inšpekcijskim pregledom (januarja 2014) je bilo že ugotovljenih več bistvenih pomanjkljivosti.
It was decided that a re-inspection would be done after one year to assess the progress in eliminating the major deficiencies. 
Sprejeta je bila odločitev, da bo po enem letu ponovno opravljen inšpekcijski pregled, da bi ocenili napredek pri odpravljanju bistvenih pomanjkljivosti.
A shortage of supply was expected from November 2015. 
Od novembra 2015 je bilo pričakovati nezadostno oskrbo z zdravilom.
Therefore, at present the positive benefit-risk cannot be confirmed. 
Iz tega razloga trenutno ni mogoče potrditi pozitivnega razmerja med koristmi in tveganji.
Several such products are available, both derived from human donor tissue and from ceramics. 
Takšnih izdelkov je na voljo več, izdelani pa so tako iz tkiva darovalcev kot tudi iz keramike.
The latest batch was released in January 2015 into the EU market, thus prior to the above inspection. 
Zadnja serija je bila na trg EU sproščena januarja 2015, torej pred omenjenim inšpekcijskim pregledom.
From a public health perspective, there was no indication of risks to patients linked to the inspection findings. 
Z vidika javnega zdravja ni bilo nobenih znakov tveganja za bolnike, kar zadeva ugotovitve inšpekcijskega pregleda.
• The Committee reviewed all available data submitted by the MAH during the procedure under Article 20 of Regulation (EC) No 726/2004 
• Odbor je pregledal vse razpoložljive podatke, ki jih je predložil imetnik dovoljenja za promet v okviru postopka v skladu s členom 20 Uredbe (ES) št. 726/2004.
The main concern identified was potential for particulate contamination. 
Glavni ugotovljeni pomislek je bila nevarnost kontaminacije z delci.
CHMP opinion Whereas 
Mnenja CHMP Ob upoštevanju naslednjega:
• There is no alternative manufacturing site authorised within the marketing authorisation dossier; 
• v dokumentaciji dovoljenja za promet ni odobren noben nadomesten proizvodni obrat;
An Article 20 of Regulation (EC) No 726/2004 was initiated by the EC on 23 July 2015 for the above concerns and their impact on the benefit-risk balance of InductOs to be determined and to decide if the relevant marketing authorisation should be maintained, varied, suspended or revoked. 
23. julija 2015 je Evropska komisija ukrepala v skladu s členom 20 Uredbe (ES) št. 726/2004 z namenom opredelitve omenjenih pomislekov in njihovega vpliva na razmerje med koristmi in tveganji zdravila InductOs ter sprejetja odločitve, ali naj se zadevno dovoljenje za promet ohrani, spremeni, začasno umakne ali ukine.
On 23 July 2015, the CHMP also adopted a list of questions to be addressed by the MAH. 
23. julija 2015 je CHMP prav tako sprejel seznam vprašanj za imetnika dovoljenja za promet.
No other ‘morphogenetic proteins' (such as InductOs) are available in the EU but substances known as ‘graft extenders' reduce the required amount of bone graft (but not completely replace the grafts). 
V EU ni na voljo drugih proteinov za morfogenezo (kot je zdravilo InductOs), so pa na voljo nosilni materiali, ki zmanjšujejo potrebno količino kostnega presadka (vendar presadka ne nadomestijo v celoti).
- The CHMP considers that at present the particulars and documents provided for in Article 8(3) of Directive 2001/83/EC, are incorrect; 
- CHMP meni, da so podatki in dokumenti, ki so določeni v členu 8(3) Direktive 2001/83/ES, trenutno netočni;
Annex I Scientific conclusions 
Priloga I
The final statement of non-compliance was issued and entered in the Community database by the Netherlands (IGZ) in accordance with Article 111 (7) of Directive 2001/83/EC on 23 July 2015. 
23. julija 2015 je Nizozemska (IGZ) objavila končno izjavo o neskladnosti in jo vnesla v podatkovno zbirko Skupnosti v skladu s členom 111(7) Direktive 2001/83/ES.
The CHMP also considers that no product is recommended to be recalled from the market, as the current product on the market was released under a valid GMP certificate in January 2015. 
CHMP prav tako meni, da ni treba priporočiti odpoklica nobenega izdelka s trga, saj je bil izdelek, ki je trenutno na trgu, dan na trg v skladu z veljavnim potrdilom o dobri proizvodni praksi januarja 2015.
However the CHMP also noted that although the findings may not pose a risk to patients, the sponge should not include any other unwanted components/contaminants and the MAH must undertake efforts to remove these and comply with the legal obligations. 
CHMP je poleg tega menil, da kljub temu, da sodeč po ugotovitvah ni tveganj za bolnike, goba ne bi smela vključevati nobenih drugih neželenih komponent/kontaminantov ter da mora imetnik dovoljenja za promet izvesti ukrepe za njihovo odstranitev in skladnost s pravnimi obveznostmi.
This action determined that no new batches of InductOs could be produced nor released in the EU. 
Ta ukrep je pomenil, da v EU ne bo možno proizvesti niti sprostiti novih serij zdravila InductOs.
InductOs, is a kit for implant, authorised centrally since 2002 for single level lumbar interbody spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non-operative treatment for this condition. 
Zdravilo InductOs je komplet za vsaditev, odobren po centraliziranem postopku od leta 2002 za enonivojsko interkorpusno fuzijo ledvene hrbtenice kot nadomestilo za avtogeni kostni presadek pri odraslih z degenerativno boleznijo medvretenčnih ploščic, ki so bili zaradi te bolezni vsaj 6 mesecev neoperativno zdravljeni.
As mentioned above, the April 2015 inspection found that the corrective action plan failed and the contamination of ACS with particulate matter was not under control and quality system not aiming for continuous improvement. 
Kot navedeno, je bilo pri inšpekcijskem pregledu aprila 2015 ugotovljeno, da akcijski načrt s popravnimi ukrepi ni bil uspešno izveden, da možnost kontaminacije absorpcijske kolagenske gobe z delci ni pod nadzorom in da sistem kakovosti ni usmerjen v stalne izboljšave.
Consequently, the Netherlands issued a draft statement of GMP non -compliance for this manufacturer which is the only existent one. 
Nizozemska je na podlagi tega objavila osnutek izjave o neskladnosti tega proizvajalca, ki je edini obstoječi proizvajalec, z dobro proizvodno prakso.
It was noted that alternative treatments are available, including the use of autogenous bone grafts, which are usually harvested from the iliac crest. 
Ugotovljeno je bilo, da so na voljo alternativne možnosti, vključno z uporabo avtogenega kostnega presadka, ki se običajno pridobi iz črevničnega grebena.
On 23 July, the CHMP considered the need to take provisional measures to be applied immediately, notably a withdrawal from the market and/or suspension of the marketing authorisation, as requested by the EC. 
23. julija je CHMP na zahtevo Evropske komisije obravnaval potrebo po sprejetju in takojšnjem začetku izvajanja začasnih ukrepov, in sicer umika s trga in/ali začasnega umika dovoljenja za promet.
The CHMP noted that, following the inspection in April 2015, no batches of InductOs had been released in the EU as recommended by the inspectors. 
CHMP je ugotovil, da po inšpekcijskem pregledu aprila 2015 v skladu s priporočili inšpektorjev v EU niso bile sproščene nove serije zdravila InductOs.
Therefore, and taking into account the assessment of the latest PSUR for InductOs dated April 2015 showing no signals in this regard, the CHMP was of the view that there was no need to adopt provisional measures for InductOs. 
Iz tega razloga in ob upoštevanju, da v oceni zadnjega rednega posodobljenega poročila o varnosti (PSUR) za zdravilo InductOs iz aprila 2015 ni bilo tovrstnih znakov, je CHMP menil, da ni potrebe po sprejetju začasnih ukrepov za zdravilo InductOs.
The CHMP, having considered all the data provided by the MAH, considers that there is no apparent identified safety concern nor seems to have risk to patients associated with the contamination of the ACS with particulate matter. 
CHMP po proučitvi vseh podatkov, ki jih je predložil imetnik dovoljenja za promet, meni, da niso bili ugotovljeni nobeni očitni pomisleki glede varnosti niti tveganja za bolnike v zvezi s kontaminacijo absorpcijske kolagenske gobe z delci.
This has to be applied to the sponge which is thereafter implanted into patients. 
Pripravljeno zdravilo je treba nanesti na gobo, ki se nato vsadi bolniku.
Healthcare professionals using InductOs were advised to follow the instructions in the product information as usual and a Direct Health Care Professional Communication (DHPC) was adopted and agreed to be distributed on 12 August by the MAH. 
Zdravstvenim delavcem, ki uporabljajo zdravilo InductOs, je bilo svetovano, naj kot običajno upoštevajo navodila v informacijah o zdravilu, imetnik dovoljenja za promet pa je 12. avgusta sprejel neposredno obvestilo za zdravstvene delavce in se zavezal, da ga bo slednjim tudi posredoval.
InductOs is also indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation. 
Zdravilo InductOs je prav tako indicirano za zdravljenje akutnih zlomov golenice pri odraslih, kot dodatek standardni oskrbi z uporabo redukcije odprtega zloma in intramedularne fiksacije z nepovrtanimi žeblji.
Standard of care in the EU consists of surgical intervention using reamed or unreamed intramedullary nailing with locking screws. 
Standardna oskrba v EU zajema kirurški poseg z intramedularnim žebljanjem s povrtavanjem ali brez povrtavanja in z zaklepnimi vijaki.
• Integra LifeSciences Corporation site is not in compliance with EU GMP for the manufacture of the absorbable collagen sponge (ACS), part of the medicinal product, InductOs; 
• proizvodni obrat družbe Integra LifeSciences Corporation ni skladen z dobro proizvodno prakso EU za proizvodnjo absorpcijske kolagenske gobe, ki je del zdravila InductOs;
The kit consists of a powder containing the active substance, dibotermin alfa, a solvent and a matrix (absorbable collagen sponge, ACS). 
Komplet vsebuje prašek z zdravilno učinkovino dibotermin alfa, vehikel in matriks (absorpcijsko kolagensko gobo).
For the suspension to be lifted, the marketing authorisation(s) holder(s) should have a valid GMP compliance statement for the manufacturer of the ACS, fulfilling the requirements set out in Article 46 of Directive 2001/83/EC. 
Imetnik(i) dovoljenj(a) za promet mora(jo) za preklic umika predložiti veljavno izjavo o skladnosti proizvajalca absorpcijske kolagenske gobe z dobro proizvodno prakso, ki izpolnjuje zahteve iz člena 46 Direktive 2001/83/ES.
- The CHMP considers that the absence of GMP compliance of the manufacturing site of the absorbable collagen sponge, part of the medicinal product precludes at present the confirmation of the benefit-risk of InductOs; 
- CHMP meni, da zaradi neskladnosti proizvodnega obrata za absorpcijsko kolagensko gobo z dobro proizvodno prakso del zdravila trenutno preprečuje potrditev razmerja med koristmi in tveganji zdravila InductOs;
USA), was inspected last in April 2015 by the Netherlands and Spain and found to be not compliant with the legal requirements and/or the principles and guidelines of GMP as provided for by Union law. 
Pri proizvajalcu absorpcijske kolagenske gobe, družbi Integra LifeSciences Corporation (ILS) s sedežem v tretji državi (tj. v ZDA), je bil inšpekcijski pregled nazadnje opravljen aprila 2015 - pregled sta opravili Nizozemska in Španija - in ugotovljeno je bilo, da ne izpolnjuje pravnih obveznosti in/ali načel in smernic dobre proizvodne prakse, kot jih določa zakonodaja Unije.
As a consequence, the CHMP recommends the suspension of the marketing authorisation for InductOs in accordance with Article 116, second paragraph of the said Directive. 
zato CHMP priporoča začasen umik dovoljenja za promet z zdravilom InductOs v skladu z drugim odstavkom člena 116 omenjene direktive.
No further product was released after the GMP non-compliance certificate was issued and the latest information on stock indicates that InductOs will be available until end of December 2015. 
Po izdaji potrdila o neskladnosti z dobro proizvodno prakso ni bil na trg dan noben izdelek in zadnje informacije o zalogah kažejo, da bo zdravilo InductOs na voljo do konca decembra 2015.
The CHMP is therefore of the opinion that the marketing authorisation(s) for InductOs should be suspended in accordance with Article 116, second paragraph of the said Directive. 
CHMP zato meni, da bi bilo treba dovoljenje oziroma dovoljenja za promet z zdravilom InductOs začasno umakniti v skladu z drugim odstavkom člena 116 navedene direktive.
At that time, following a corrective action plan, restricted GMP certificate valid until January 2015 was issued. 
Takrat je bil oblikovan akcijski načrt s popravnimi ukrepi in izdano omejeno potrdilo o skladnosti z dobro proizvodno prakso, veljavno do januarja 2015.
For the treatment of tibia fractures, fixation with a reamed nail instead of InductOs plus unreamed nail fixation is an alternative option. 
Za zdravljenje zlomov golenice je namesto kombinacije zdravila InductOs in fiksacije z nepovrtanimi žeblji alternativna možnost fiksacija s povrtanimi žeblji.
On the basis of the above and taking into account that InductOs has no alternative ACS manufacturing site authorised: 
Na podlagi zgoraj navedenega in ob upoštevanju, da za zdravilo InductOs ne obstaja odobren nadomestni proizvodni obrat za absorpcijsko kolagensko gobo:
As such it is consequently inspected against EU-GMP guidelines. 
Zaradi tega mora uspešno opraviti pregled skladnosti s smernicami EU za dobro proizvodno prakso.
ACS has been classified as an excipient of InductOs. 
Absorpcijska kolagenska goba je opredeljena kot pomožna snov pri zdravilu InductOs.
Given the findings, the CHMP considered that the quality of InductOs cannot be assured at present due to the lack of GMP compliance of the ACS issued on 23 July 2015. 
Na podlagi ugotovitev je CHMP menil, da glede na izjavo, objavljeno 23. julija 2015, o neskladnosti absorpcijske kolagenske gobe z dobro proizvodno prakso trenutno ni mogoče zagotoviti kakovosti zdravila InductOs.
Strength Pharmaceutical Form 
Pot uporabe Stična ovojnina Vsebina
• Drink the liquid straight away. 
• Tekočino takoj popijte.
Date of first authorisation: 2 February 2016 Date of latest renewal: 12 December 2016 
Datum prve odobritve: 2. februar 2016 Datum zadnjega podaljšanja: 12. december 2016
These changes are small and not likely to be of clinical significance. 
Te spremembe so majhne in ni verjetno, da bi bile klinično pomembne.
All patients received at least one prior line of therapy. 
Vsi bolniki so prejeli vsaj eno predhodno linijo zdravljenja.
It may also help to reduce the size of the tumour. 
Pomaga lahko tudi zmanjšati velikost tumorja.