natgillin/translations-raw huggingface dataset:
It is a copy of a protein called osteogenic protein 1, also known as bone morphogenic protein 7 (BMP-7), which is produced naturally by the body and helps the formation of new bone tissue. 
Učinkovina je kopija beljakovine, imenovane osteogeni protein 1, znane tudi kot kostni morfogeni protein 7 (BMP-7), ki ga telo proizvaja naravno in pomaga pri tvorjenju novega kostnega tkiva.
• patients with an auto-immune disease (a disease caused by the body's own defence system attacking normal tissue); 
• bolnikih z avtoimunsko boleznijo (boleznijo bolnikovega lastnega obrambnega sistema, ki napada normalno tkivo),
These studies will look at the medicine's safety and effectiveness, and how it is used in real life. 
V teh študijah bodo raziskovali varnost in učinkovitost zdravila ter njegovo dejansko uporabo.
This is a summary of the European public assessment report (EPAR) for Opgenra. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Opgenra.
Eptotermin alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce eptotermin alfa. 
Eptotermin alfa se proizvaja z metodo, imenovano „tehnologija rekombinantne DNK“: proizvajajo ga celice, ki so prejele gen (DNK), zaradi katerega lahko tvorijo eptotermin alfa.
All of the patients were eligible for an autograft. 
Vsi bolniki so bili primerni za avtologno presaditev.
The Committee recommended that Opgenra be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Opgenra odobri dovoljenje za promet.
In addition, Opgenra had advantages over autograft, including shorter operations, less blood loss and less pain. 
Poleg tega ima zdravilo Opgenra prednosti pred avtolognim presadkom, vključno s krajšimi operativnimi posegi, manjšo izgubo krvi in manj bolečinami.
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 Opgenra. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Opgenra, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
• patients who have an active infection at the operation site or have had repeated infections; 
• bolnikih z aktivno okužbo na mestu operativnega posega ali bolniki s ponavljajočimi se okužbami;
What benefit has Opgenra shown during the studies? 
Kakšne koristi je zdravilo Opgenra izkazalo med študijami?
Other information about Opgenra 
Druge informacije o zdravilu Opgenra
Opgenra is used in adults with spondylolisthesis. 
Zdravilo Opgenra se uporablja pri odraslih s spondilolistezo.
Opgenra has been studied in one main study involving 336 patients who needed spinal fusion surgery for spondylolisthesis. 
Zdravilo Opgenra so raziskovali v eni glavni študiji pri 336 bolnikih, ki so potrebovali operativni poseg za spinalno fuzijo zaradi spondilolisteze.
This is a condition where one lumbar vertebra (one of the bones in the lower part of the spine) has slipped forward so that it is not in line with the vertebra below it. 
To je stanje, pri katerem se eno ledveno vretence (ena od kosti v križnem delu hrbtenice) premakne naprej, tako da ni več poravnano z enim vretencem nižje.
• patients who have received a medicine containing BMP in the past; 
• bolnikih, ki so v preteklosti že prejeli zdravilo s kostnim morfogenim proteinom (BMP);
It is supplied as two vials, one containing eptotermin alfa and another containing a substance called carmellose. 
Zdravilo je dobavljeno v dveh vialah, od katerih ena vsebuje eptotermin alfa, druga pa snov, imenovano karmeloza.
Why has Opgenra been approved? 
Zakaj je bilo zdravilo Opgenra odobreno?
In addition, some side effects are seen in between 1 and 10 patients in 100 following spine surgery itself, including infection after the operation, wound dehiscence (opening of the wound), secretion (seepage) and erythema (redness of the skin). 
Poleg tega so nekatere neželene učinke opazili pri 1 do 10 bolnikih od 100 po samem operativnem posegu na hrbtenici, vključevali pa so okužbo po operaciji, dehiscenco rane (odpiranje rane), sekrecijo (mezenje) in eritem (rdečino kože).
During an operation, the surgeon applies Opgenra directly along each side of the two vertebrae to help new bone develop and to make the vertebrae fuse together. 
Kirurg med operacijo nanese zdravilo Opgenra neposredno vzdolž vsake strani obeh vretenc, da bi spodbudil razvoj nove kosti in da bi povzročil združitev vretenc.
What is the risk associated with Opgenra? 
Kakšna tveganja so povezana z zdravilom Opgenra?
Despite the lower effectiveness, there was sufficient evidence from the study and from the published literature to support the use of Opgenra in patients in whom autograft has failed or who must not undergo the procedure. 
Kljub nižji učinkovitosti je študija zagotovila dovolj dokazov, objavljena literatura pa dovolj podpore za uporabo zdravila Opgenra pri bolnikih, pri katerih avtologni presadek ni bil uspešen ali pri katerih se poseg ne sme izvesti.
The most common side effects with Opgenra (seen in between 1 and 10 patients in 100) are heterotopic bone formation (bone formation outside the fusion area) and pseudoarthrosis (failure of the spine to fuse). 
Najpogostejši neželeni učinki zdravila Opgenra (opaženi pri 1 do 10 bolnikih od 100) so heterotopična okostenitev (tvorjenje kostnine izven območja fuzije) in psevdoartroza (neuspela spinalna fuzija).
Treatment was defined as ‘successful' when bone could be seen between the affected vertebrae on X-rays, and the patient had shown improvement in disability, with no need for further treatment of the spine, no serious side effects and no worsening of the symptoms caused by pressure on the nerves. 
Zdravljenje so opredelili kot uspešno, če je bilo na rentgenskih slikah mogoče videti kostno tkivo med prizadetimi vretenci in so bolniki pokazali napredek v svojem stanju, brez potrebe po nadaljnjem zdravljenju hrbtenice, resnih neželenih učinkov in poslabšanja simptomov, ki jih povzroča pritiskanje na živce.
• patients who do not have adequate skin covering or blood supply at the operation site; 
• bolnikih, ki na mestu operativnega posega nimajo zadostne prekritosti s kožo ali prekrvavljenosti;
These will include information on Opgenra's safety and remind them of how to prepare and use the medicine in an operation. 
Vsebovali bodo informacije o varnosti zdravila Opgenra ter navodila za kirurge, kako pripraviti in uporabljati zdravilo pri operativnem posegu.
The two powders are made up into a ‘suspension' (a liquid with solid particles in it) with a putty-like consistency, which is implanted in the body. 
Dva praška se pripravita v „suspenzijo“ (tekočino, ki vsebuje trdne delce), ki ima vosku podobno sestavo in se vsadi v telo.
Opgenra should not be used in people who may be hypersensitive to eptotermin alfa or any of the other ingredients. 
Zdravila Opgenra ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) eptotermin alfa ali katero koli drugo sestavino zdravila.
In the main study, Opgenra was not as effective as autograft in patients who were eligible for an autograft. 
Zdravilo Opgenra v glavni študiji ni bilo tako učinkovito kot avtologni presadek pri bolnikih, ki so bili do njega upravičeni.
For the full list of all side effects reported with Opgenra, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Opgenra, glejte navodilo za uporabo.
The replacement eptotermin alfa acts in the same way as naturally produced BMP-7. 
Nadomestni eptotermin alfa deluje enako kot naravni morfogeni protein 7 (BMP-7).
Opgenra is only used by a surgeon who is appropriately qualified. 
Zdravilo Opgenra lahko uporabljajo samo ustrezno usposobljeni kirurgi.
The CHMP decided that Opgenra's benefits are greater than its risks for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Opgenra pri posterolateralni lumbalni spinalni fuziji pri odraslih bolnikih s spondilolistezo, pri katerih avtologni presadek ni bil uspešen ali pa je kontraindiciran, večje od z njim povezanih tveganj.
When implanted, eptotermin alfa stimulates the formation of new bone. 
Eptotermin alfa pri vsaditvi stimulira tvorjenje novega kostnega tkiva.
Opgenra is used only in patients who have previously had surgery using an autograft (a bone graft taken from their own body, usually the hip) that has failed or when an autograft must not be carried out. 
Zdravilo Opgenra se uporablja samo pri bolnikih, ki so že prestali operativni poseg z avtolognim presadkom (kostnim presadkom, ki se odvzame iz bolnikovega lastnega telesa, navadno kolka) z neuspešnim izidom ali pri tistih bolnikih, pri katerih se avtolognega presadka ne sme uporabiti.
This helps to fuse the two vertebrae in patients having surgery for spondylolisthesis. 
To pomaga pri združevanju dveh vretenc pri bolnikih, ki so prestali operativni poseg zaradi spondilolisteze.
The active substance in Opgenra, eptotermin alfa, acts on the bone. 
Zdravilna učinkovina zdravila Opgenra, eptotermin alfa, deluje na kosti.
Opgenra is a medicine that contains the active substance eptotermin alfa. 
Opgenra je zdravilo, ki vsebuje zdravilno učinkovino eptotermin alfa.
Spondylolisthesis can be treated using surgery to fuse (join) the vertebrae above and below the site where the slip occurred. 
Spondilolisteza se lahko zdravi z operativnim posegom, pri kateri se združi (poveže) vretence nad mestom zdrsa in pod njim.
The study compared surgery using Opgenra and surgery using bone autografts. 
V študiji so primerjali uporabo zdravilo Opgenra in operativni poseg z uporabo kostnega avtolognega presadka.
How has Opgenra been studied? 
Kako je bilo zdravilo Opgenra raziskano?
How is Opgenra used? 
Kako se zdravilo Opgenra uporablja?
What is Opgenra used for? 
Za kaj se zdravilo Opgenra uporablja?
What is Opgenra? 
Kaj je zdravilo Opgenra?
Osigraft is used to repair fractures (breaks) of the tibia (shin bone). 
Zdravilo Osigraft se uporablja pri reparaciji zlomov golenice.
2 vials + 1 infusion set + 2 transfer devices + 1 short catheter 
Viala (steklo) 2 viali + 1 komplet za infundiranje 2 napravi za prenos + 1 kratek kateter
1 vial + 1 infusion set +1 transfer device + 1 short catheter 
Viala (steklo) 1 viala + 1 komplet za infundiranje 1 naprava za prenos + 1 kratek kateter
Furthermore, the PRAC recommended that in due course, appropriate communications should be issued. 
Poleg tega je odbor PRAC priporočil, da se v ustreznem času izdajo ustrezna obvestila.
The first Marketing Authorisation (MA) in the EU was granted in 05 April 1963. 
Prvo dovoljenje za promet z zdravilom v EU je bilo izdano 5. aprila 1963.
Safety data from spontaneous reports 
Varnostni podatki iz spontanih poročil
The PRAC, as a consequence, concluded that pursuant to Article 116 of Directive 2001/83/EC 
je odbor PRAC tako zaključil, da je v skladu s členom 116 Direktive 2001/83/ES
The PRAC adopted a recommendation on 22 February 2016 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC. 
Odbor PRAC je 22. februarja 2016 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES obravnavala skupina CMDh.
1999, Study report [NP07224] 
1999, Poročilo o študiji [NP07224]
The studies were designed to address the efficacy at day 7 but did not show any efficacy at that time. 
Študije so bile načrtovane tako, da bi se obravnavala dejavnost na 7. dan, vendar tedaj učinkovitost ni bila ugotovljena.
However several methodological challenges were noted by the PRAC, the limitations of the studies being inherent to the standards at the time of registration. 
Vendar je odbor PRAC ugotovil več metodoloških nejasnosti, pri čemer so bile omejitve študij povezane s standardi v času registracije.
These 717 cases represent 65.1% of all reports for fusafungine found in MAH's safety database. 
Teh 717 primerov predstavlja 65,1 % vseh poročil v zvezi s fuzafunginom, ugotovljenih v zbirki podatkov o varnosti imetnika dovoljenja za promet z zdravili.
The MAH also proposed to add a recommendation to stop the treatment in case of allergic reactions and to delete one of the indications. 
Imetnik dovoljenja za promet z zdravili je predlagal tudi, da se doda priporočilo o ustavitvi zdravljenja v primeru alergijskih reakcij in da se ena od indikacij izbriše.
Safety data from clinical trials 
Varnostni podatki iz kliničnih preizkušanj
Although some efficacy was shown at day 4, the PRAC is of the view that the endpoints were not clinically meaningful; at day 7 no differences were identified and the product was not superior to placebo. 
Čeprav je bila na 4. dan ugotovljena določena učinkovitost, je odbor PRAC menil, da so bile končne točke klinično nepomembne; na 7. dan razlike niso bile ugotovljene, zdravilo pa ni bilo boljše od placeba.
In addition, Italy had concerns with regards to the benefit of fusafungine in its approved indications. 
Poleg tega je imela Italija pomisleke o koristih fuzafungina pri odobrenih indikacijah.
The estimated total exposure to fusafungine was of 727 patients. 
Celotna izpostavljenost fuzafunginu je bila ocenjena pri 727 bolnikih.
Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the PRAC recommends the revocation of the marketing authorisations for all medicinal products referred to in Annex I. 
Odbor PRAC zato v skladu s členoma 31 in 32 Direktive 2001/83/ES priporoča razveljavitev dovoljenja za promet z vsemi zdravili, navedenimi v Prilogi I.
Therefore, on 06 August 2015 the Italian NCA (AIFA) triggered a referral under Article 31 of Directive 2001/83/EC and asked the PRAC to assess the impact of the above concerns on the benefit-risk balance of fusafungine-containing medicinal products in all indications and age groups, and issue a recommendation on whether the products should be maintained, varied, suspended or revoked. 
Zato je italijanski pristojni nacionalni organ (AIFA) 6. avgusta 2015 sprožil napotitev v skladu s členom 31 Direktive 2001/83/ES in prosil odbor PRAC za oceno vpliva zgoraj opisanih pomislekov na razmerje med tveganji in koristmi zdravil, ki vsebujejo fuzafungin, pri vseh indikacijah in starostnih skupinah ter izdajo priporočila o tem, ali je treba dovoljenja za promet z zdravili ohraniti, spremeniti, začasno preklicati ali ukiniti.
The 717 spontaneous cases of allergic reactions include a total of 1,065 ADRs referring to allergic reactions. 
717 spontanih primerov alergijskih reakcij vključuje 1 065 neželenih učinkov zdravila, ki se nanašajo na alergijske reakcije.
The PRAC noted that clinical trials with limited numbers of patients cannot be used to determine the incidence of rare adverse reactions. 
Odbor PRAC je ugotovil, da kliničnih preizkušanj z omejenim številom bolnikov ni mogoče uporabiti za določitev incidence redkih neželenih učinkov.
The serious and fatal cases concern patients of different age-ranges; the contraindications for patients under 12 years of age and patients with a history of allergy will not prevent severe or life-threatening events. 
Resni in smrtni primeri prizadenejo bolnike različnih starostnih skupin; kontraindikacije za bolnike, mlajše od 12 let, in bolnike z alergijo v anamnezi ne bodo preprečile življenjsko nevarnih dogodkov.
Therefore, the potential for microbial resistance to fusafungine is another uncertainty, since there is insufficient data to assess this potential risk. 
Nejasna je torej tudi možnost odpornosti mikrobov za fuzafungin, saj ni zadostnih podatkov za oceno tega morebitnega tveganja.
The PRAC noted that the fatal and serious cases had been reported across all age groups and that in light of this, there was no reassurance that restricting use to certain age groups would be effective in minimising risk. 
Odbor PRAC je ugotovil, da so pri vseh starostnih skupinah poročali o smrtnih in resnih primerih, in da ob upoštevanju tega ni zagotovila, da bi omejitev uporabe na samo nekatere starostne skupine lahko učinkovito zmanjšala tveganje.
It was also noted that while EUCAST is currently recommending to use epidemiological cut-off values (ECOFFs) for topical agents, in particular when clinical breakpoints are not available, ECOFFs for fusafungine are not available on the EUCAST website. 
Ugotovljeno je bilo tudi, da čeprav odbor EUCAST trenutno priporoča uporabo epidemioloških mejnih vrednosti (ECOFF) za topične učinkovine, zlasti kadar klinične mejne vrednosti niso na voljo, na spletni strani odbora EUCAST vrednosti ECOFF niso na razpolago.
Mechanisms of actions 
Mehanizem delovanja
The risk of cross-resistance cannot be excluded as well. 
Izključiti ni mogoče niti tveganja za navzkrižno odpornost.
Fusafungine for oromucosal and nasal use was studied in several clinical studies. 
Fuzafungin za oromukozno in nazalno uporabo so proučevali v več kliničnih študijah.
In the majority of cases (62.8%), the time interval from exposure to onset of first signs and symptoms of allergic episodes showed the likelihood of the causality of fusafungine in the hypersensitivity reaction (i.e. within 24 hours). 
V večini primerov (62,8 %) je časovni razmik od izpostavitve do pojava prvih znakov in simptomov alergijskih epizod kazal na verjetnost za vzročno povezanost med fuzafunginom in preobčutljivostno reakcijo (tj. v 24 urah).
Considering the data provided for the other indications (other than rhinopharyngitis), the PRAC is of the opinion that the quality of the clinical evidence is very low for all these indications. 
Ob upoštevanju podatkov za druge indikacije (razen za rinofaringitis) je odbor PRAC menil, da je kakovost kliničnih dokazov pri vseh teh indikacijah zelo slaba.
Of these, 5 cases are related to hypersensitivity, the sixth case is a case of toxic shock syndrome, which based on the course of the events was probably caused by the preceding trauma of the patient. 
Od teh jih je bilo pet povezanih s preobčutljivostjo, šesti primer pa je bil primer sindroma toksičnega šoka, ki ga je sodeč po poteku dogodkov povzročila predhodna poškodba bolnika.
However based on the evidence of allergic reactions reported in children 12-17 years old as well as in adult population, the Italian National Competent Authority (NCA) considered that the above-mentioned major safety concerns will not be fully controlled in clinical practice despite the risk minimisation measures in place. 
Na podlagi podatkov o alergijskih reakcijah pri otrocih, starih od 12 do 17 let, ter pri odrasli populaciji pa je italijanski pristojni nacionalni organ presodil, da zadevni varnostni pomisleki v klinični praksi kljub ukrepom za zmanjševanje tveganja ne bodo v celoti pod nadzorom.
In addition, concerns have also been raised with regards to the role of the excipients in the occurrence of allergic reactions. 
Poleg tega se je pojavila zaskrbljenost o vlogi pomožnih snovi pri pojavu alergijskih reakcij.
2002, Study report [NP08516] 4 Cuénant G. Intérêt de Locabiotal Pressurisé dans les rhinosinusites. 
2002, Poročilo o študiji [NP08516] 4 Cuénant G. Intérêt de Locabiotal Pressurisé dans les rhinosinusites.
Valid Marketing Authorisations of fusafungine-containing medicinal products for oral use for oromucosal and nasal use currently available in 19 Member States (see Annex I). 
Veljavna dovoljenja za promet z zdravili, ki vsebujejo fuzafungin, za peroralno uporabo ter za oromukozno in nazalno uporabo so trenutno na voljo v 19 državah članicah (glejte Prilogo I).
With regards to the allergic reactions, a total of 717 non-serious and serious cases have been spontaneously reported in patients exposed to fusafungine since the launch of the product (from 1963 up to 31 August 2015). 
V zvezi z alergijskimi reakcijami so pri bolnikih, izpostavljenih fuzafunginu, od začetka trženja zdravila (od leta 1963 do 31. avgusta 2015) poročali o skupaj 717 manj resnih in resnih primerih.
Fusafungine is a depsipeptide antibacterial produced by Fusarium lateritium strain 437. 
Fuzafungin je depsipeptidni antibiotik, ki ga tvori sev 437 glive Fusarium lateritium.
• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from Pharmacovigilance data, for fusafungine-containing products for oromucosal and nasal use (see Annex I). 
• odbor PRAC je upošteval postopek v skladu s členom 31 Direktive 2001/83/ES, ki je bila na podlagi farmakovigilančnih podatkov predložena za zdravila, ki vsebujejo fuzafungin, za oromukozno in nazalno uporabo (glejte Prilogo I);
The MAH was asked to provide a cumulative review of all case reports, both serious and non-serious, along with causality assessment for serious cases and stratification by age as well as analyses on age and sex of patient, indication of use, duration and dose, time to onset, outcome, seriousness, concomitant medications and illnesses, relevant medical history or any other factors. 
Imetnik dovoljenja za promet z zdravili je bil naprošen, da predloži kumulativni pregled vseh poročil, resnih in manj resnih, skupaj z oceno vzročnosti med resnimi primeri in starostno stratifikacijo ter analizami po starosti in spolu bolnikov, indikaciji, trajanju in odmerku, času do pojava, izidu, resnosti, uporabi sočasnih zdravil in sočasnih boleznih, ustrezni medicinski anamnezi in drugih dejavnikih.
Moreover, the available efficacy data showed only limited efficacy in support of the claimed indications of local fusafungine in rhinopharyngitis which does not translate in evidence of a benefit for patients in the current context of the therapeutic clinical practice. 
Še več, razpoložljivi podatki o učinkovitosti so pokazali le omejeno učinkovitost v podporo predloženi indikaciji lokalnega fuzafungina pri rinofaringitisu, kar v trenutnem okviru terapevtske klinične prakse ne dokazuje koristi za bolnike.
The in vitro and in vivo data can be generally regarded as supportive of anti-inflammatory effect of fusafungine although the mechanism of action of antiinflammatory activity of fusafungine is complex and remains unknown. 
Podatke in vitro in in vivo lahko v splošnem obravnavamo, kot da podpirajo protivnetno učinkovanje fuzafungina, čeprav je mehanizem protivnetnega delovanja fuzafungina zapleten in ostaja nerazjasnjen.
Hypersensitivity including anaphylactic reactions with short time to onset can be considered as a risk related to the use of fusafungine. 
Preobčutljivost, vključno z anafilaktičnimi reakcijami s kratkim časom do pojava, se lahko obravnava kot tveganje, povezano z uporabo fuzafungina.
• The PRAC considered that the available efficacy data, including data which became available since the initial marketing authorisation, and concluded that the evidence for beneficial effects of fusafungine in all approved indications is weak and such effects are not clinically meaningful. 
• odbor PRAC je preučil razpoložljive podatke o učinkovitosti, vključno s podatki, ki so postali razpoložljivi od izdaje prvotnega dovoljenja za promet, in zaključil, da so dokazi o koristnih učinkih fuzafungina pri vseh odobrenih indikacijah šibki in da taki učinki klinično niso pomembni;
The current risk minimisations measures (restriction of the indication to acute rhinopharyngitis and additional contra-indication) are considered insufficient to mitigate the risk of serious hypersensitivity reactions. 
Trenutni ukrepi za zmanjševanje tveganja (omejitev indikacij na akutni rinofaringitis in dodatne kontraindikacije) ne zadostujejo za zmanjšanje tveganja resnih preobčutljivostnih reakcij.
Furthermore, the PRAC is of the opinion that the quality of the clinical evidence is very low for all other indications. 
Odbor PRAC je menil, da je kakovost kliničnih dokazov pri vseh drugih indikacijah zelo slaba.