natgillin/translations-raw huggingface dataset:
The company that markets Jetrea must ensure that all healthcare professionals who are expected to use Jetrea receive the summary of product characteristics for the medicine as well as an information pack to be given to patients. 
Družba, ki trži zdravilo Jetrea, mora zagotoviti, da bodo vsi zdravstveni delavci, ki naj bi to zdravilo uporabljali, prejeli povzetek glavnih značilnosti zdravila in informativno gradivo za bolnike.
The active substance in Jetrea, ocriplasmin, is similar to human plasmin, a naturally occurring enzyme in the eye which is capable of breaking down proteins between the vitreous humour and the retina which are responsible for the adhesion, thereby reducing retinal swelling and improving vision. 
Zdravilna učinkovina zdravila Jetrea, okriplazmin, je podobna humanemu plazminu, tj. encimu, ki je naravno prisoten v očesu in ima sposobnost razgradnje beljakovin med steklovino in mrežnico, ki so odgovorne za adhezijo, s čimer zmanjšuje otekanje mrežnice in izboljšuje vid.
The side effects seen with Jetrea affect the eye. 
Neželeni učinki, opaženi pri uporabi zdravila Jetrea, prizadenejo oko.
Vitreomacular traction is caused by vitreomacular adhesion in which the vitreous humour has an abnormally strong attachment to the central part of the retina (the light sensitive membrane at the back of the eye). 
Vitreomakularno trakcijo povzroča vitreomakularna adhezija, pri kateri je steklovina nenormalno tesno vezana na osrednji del mrežnice (na svetlobo občutljive membrane v ozadju očesa).
Studies have shown that Jetrea was effective in treating vitreomacular adhesion and it is therefore expected to be effective in preventing worsening of vision which may occur with untreated and progressive vitreomacular traction. 
Študije so pokazale, da je bilo zdravilo Jetrea učinkovito pri zdravljenju vitreomakularne adhezije, zato naj bi bilo učinkovito tudi pri preprečevanju poslabšanja vida, do katerega lahko pride zaradi nezdravljene in napredovale vitreomakularne trakcije.
Successful treatment of vitreomacular adhesion can help reverse disturbances of the vision caused by vitreomacular traction, and prevent further loss of vision from untreated and progressive traction at the retina. 
Uspešno zdravljenje vitreomakularne adhezije lahko pomaga odpraviti motnje vida zaradi vitreomakularne trakcije in preprečiti nadaljnjo izgubo vida zaradi nezdravljene in napredovale trakcije mrežnice.
The ophthalmologist may prescribe antibiotic eye drops before and after treatment with Jetrea to prevent eye infections. 
Oftalmolog lahko pred zdravljenjem z zdravilom Jetrea in po njem predpiše antibiotične kapljice za oko za preprečevanje očesnih okužb.
Jetrea is a medicine used to treat adults with vitreomacular traction, an eye disease that can cause severe visual disturbance. 
Zdravilo Jetrea se uporablja za zdravljenje odraslih z vitreomakularno trakcijo, tj. očesno boleznijo, ki lahko povzroči hude motnje vida.
It can only be obtained with a prescription and must be given by a qualified ophthalmologist (eye specialist) experienced in intravitreal injections (injections into the vitreous humour, the jelly-like material at the back of the eye). 
Predpisovanje in izdaja zdravila je le na recept, injicirati pa ga mora ustrezno usposobljeni oftalmolog (specialist za oči), ki ima izkušnje z dajanjem intravitrealnih injekcij (injiciranjem v steklovino, tj. želatini podobno tekočino v očesu).
Jetrea has been shown in studies to be effective in resolving the adhesion between the vitreous humour and the retina, reducing the need for surgery. 
Zdravilo Jetrea se je med študijami izkazalo za učinkovito pri odpravi adhezije med steklovino in mrežnico, s čimer se je zmanjšala potreba po kirurškem posegu.
For the full list of all side effects reported with Jetrea, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Jetrea, glejte navodilo za uporabo.
When the vitreous humour shrinks with aging, this strong attachment results in a pulling force on the retina, which causes retinal swelling and leads to blurred or distorted vision. 
Ko se steklovina z leti skrči, zaradi tesne vezave za seboj povleče tudi mrežnico, kar povzroči otekanje mrežnice in privede do zamegljenega ali popačenega vida.
How does Jetrea work? 
Kako zdravilo Jetrea deluje?
How is Jetrea used? 
Kako se zdravilo Jetrea uporablja?
Member State (in EEA) 
Država članica (v EGP)
(Invented) Name Strength 
(Izmišljeno) Ime Jakost
Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states 
Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
4 mg/40 mg tablet 
4 mg/40 mg tableta peroralna uporaba
0.10 g/1 g per 100 ml oral solution 
0.10 g/1 g na 100 ml peroralna raztopina peroralna uporaba
VASOBRAL, solution buvable en flacon 
VASOBRAL, peroralna raztopina v viali
VASOBRAL, comprimé sécable 
VASOBRAL, zarezo tableta
Marketing Authorisaton Holder 
Imetnik dovoljenja za promet z zdravilom
The Committee also noted that the last study performed in infants below one year was completed in 2001. 
Prav tako je bil Odbor seznanjen, da je bila zadnja raziskava, opravljena na dojenčkih, mlajših od enega leta, zaključena leta 2001.
There is no evidence that either short or long term protection has been impacted. 
Nikakršnih dokazov ni o vplivu na kratkoročno ali dolgoročno zaščito.
It was considered that a decision will be taken according to the responses given on quality and clinical concerns. 
Sklenil je, da bo odločitev temeljila na odgovorih o kakovosti in kliničnih zadržkih.
These changes, in principle, address the concerns raised by the CHMP and its Working Parties. 
Te spremembe se načeloma naslavljajo na zadržke, ki so se pojavili pri CHMP in njegovih delovnih skupinah.
In the past experience, there has never been an instance when high performance in adolescents and young adults did not correspond with high performance in infants. 
V preteklih izkušnjah se še ni zgodilo, da bi velik učinek pri mladostnikih in mladih odraslih ne odgovarjal velikemu učinku pri dojenčkih.
Therefore, the results of this study provide evidence that the currently available product is providing the expected level of protective antibodies in all populations for which it is indicated. 
Zato rezultati te raziskave dokazujejo, da daje trenutno razpoložljiv izdelek pričakovano raven zaščitnih protiteles v vseh populacijah, za katere je indiciran.
There are some indications that the Hep B vaccine currently produced is less immunogenic than the vaccine produced in the 1990's. 
Nekaj indikacij kaže na to, da je cepivo Hep B, ki se trenutno izdeluje, manj imunogeno kot cepivo, izdelano v 90-ih letih prejšnjega stoletja.
Pending the outcome of the studies, the MAH committed to amend the SPC sections 4.2, 4.4, 4.5 (where relevant) and 5.1 as follows: 
V pričakovanju izida raziskav se imetnik dovoljenja za promet zavezuje k dopolnitvi poglavij 4.2, 4.4, 4.5 (kjer je primerno) in 5.1 v SPC z naslednjim besedilom:
The CHMP endorsed the new product information and agreed to finalise the article 20 procedure without any further regulatory action. 
CHMP je potrdil nove podatke o izdelku in sklenil brez nadaljnjih regulatornih ukrepov dokončati postopek iz člena 20.
Information will be provided to health care professionals and will ensure that the vaccine will be correctly used in the different age and risk categories. 
Podatki bodo na voljo zdravnikom in bodo zagotavljali pravilno uporabo cepiva v različnih starostnih kategorijah in kategorijah tveganja.
The reason for decreasing immunogenicity over several years remains still unidentified. 
Razlog za večletno padajočo imunogenost še ni znan.
These trials were carried out in different risk groups and age categories, i.e. children born to Hepatitis B positive mothers, infants, healthy young adults and healthy subjects between 16-35 years of age. 
Preizkušanje so izvedli v različnih skupinah tveganja in starostnih kategorijah, npr. otrocih, rojenih hepatitis B pozitivnim materam, dojenčkih, zdravih mladih odraslih in zdravih osebah, starih od 16 do 35 let.
The results from these three trials with product manufactured in the current facility, confirm solid, reproducible performance based on these recent historical data and should also predict performance as expected in other populations as well. 
Rezultati teh treh preizkušanj, kjer je izdelek proizveden v trenutni ustanovi, potrjujejo trdno, ponovljivo delovanje, ki temelji na teh nedavnih historičnih podatkih in prav tako napoveduje pričakovano delovanje v drugih populacijah.
The most recent immunogenicity data comes from the interim analysis of the V232-054 trial, this is the third trial in the past few years to study the current product (from the BTMC manufacturing facility) in young adults using the same dosing schedule (the other two trials are V501-011 and V232052). 
Najnovejši podatki imunogenosti prihajajo iz vmesne analize preizkušanja V232-054, to je tretjega preizkušanja v zadnjih nekaj letih, ki preučuje trenutni proizvod (iz proizvodne ustanove BTMC) na mladih odraslih z enakim urnikom odmerjanja (drugi dve preizkušanji sta V501-011 in V232-052).
The CHMP debated the current lack of knowledge about the clinical significance of the findings and immune memory in general and agreed that these issues needed to be carefully explored before deciding on regulatory action. 
CHMP je razpravljal o trenutnem pomanjkanju znanja o kliničnem pomenu izsledkov in o imunološkem spominu na splošno ter je sklenil, da je potrebno pred uvedbo regulatornih ukrepov ta vprašanja temeljito proučiti.
As a consequence the data obtained so far must be interpreted with caution since they were generated using the paediatric (5µg) dose of Hep B vaccine produced before 2001. 
Zato je treba do sedaj zbrane podatke pazljivo razlagati, saj so bili sproženi z otroškim (5µg ) odmerkom cepiva Hep B, izdelanim pred letom 2001.
Although the root cause for reduced immunogenicity during the past 5 years is still not ascertained, evidence was provided that the manufacturing process seems now to be better controlled. 
Kljub temu, da temeljni razlog za znižano imunogenost v zadnjih petih letih še vedno ni ugotovljen, dokazi kažejo, da je proizvodni postopek danes bolje nadzorovan.
• The use of this vaccine will not pose an immediate risk to any of the target groups the vaccine is indicated for. 
• Uporaba tega cepiva ne bo predstavljala neposrednega tveganja za katerokoli ciljno skupino, kateri je cepivo namenjeno.
Due to the relatively high risk of infection, the group of infants born to Hepatitis B positive mothers represents the population, which would be most vulnerable to a possible insufficient immunogenicity of the vaccine. 
Zaradi relativno visokega tveganja za okužbo predstavlja skupina dojenčkov, rojenih hepatitis B pozitivnim materam, populacijo, ki bi bila najbolj občutljiva za nezadostno imunogenost cepiva.
The CHMP concluded that the use of this vaccine will not pose an immediate risk to any of the target groups the vaccine is indicated for. 
CHMP je zaključil, da uporaba tega cepiva ne bo predstavljala neposrednega tveganja za katerokoli ciljno skupino, kateri je cepivo namenjeno.
The MAH developed an upgraded manufacturing process to increase immunogenicity. 
Imetnik dovoljenja za promet je razvil posodobljen proizvodni postopek za povečanje imunogenosti.
• The need of the 4th dose at 12 months has been reinforced, when the compressed administration schedule 0, 1, 2 and 12 months is used 
• Pri skrčeni shemi odmerjanja pri 0, 1, 2 in 12 mesecih se je povečala potreba po četrtem odmerku pri 12-ih mesecih.
• The recommendations for serologic testing, and administration of additional doses if needed, in immunocompromised patients, in non-responders of other high risk groups, and in the case of presumed exposure to hepatitis B, have been strengthened. 
• Priporočila za serološko testiranje in odmerjanje dodatnih odmerkov, če so potrebni, pri imunsko oslabljenih bolnikih, pri bolnikih drugih tveganih skupin, ki se ne odzivajo, in v primeru predpostavljene izpostavljenosti hepatitisu B, so bili ojačani.
As there are currently no reports on increased numbers of Hepatitis B breakthrough cases after HBVAXPRO vaccination, considering that the EU is a low endemic region, no immediate safety signal could be identified by the CHMP. 
Ker trenutno ne poročajo o povečanem številu primerov izbruha hepatitisa B po cepljenju s cepivom HBVAXPRO in ob upoštevanju, da je EU nizko endemično območje, CHMP ne vidi nikakršnega takojšnjega opozorilnega signala.
• The concomitant administration of pneumococcal conjugate vaccine is not recommended since this has not been sufficiently studied for HBVAXPRO. 
• Sočasno uporaba pnevmokoknega konjugiranega cepiva ni priporočena, saj tovrstne raziskave za HBVAXPRO niso bile opravljene.
In addition, a review of clinical performance as assessed by protection against disease as noted in the V121-018 trial supports the conclusion that the hepatitis B vaccines remain effective in decreasing hepatitis B infection and its serious sequelae. 
Poleg tega pregled kliničnih učinkov, opredeljenih kot zaščita pred boleznijo, kot je navedeno v preizkušanju V121-018, podpira zaključek, da ostajajo cepiva proti hepatitisu B učinkovita pri zmanjševanju okužb s hepatitisom B in njihovih resnih posledic.
Revised SPCs and PLs provide updated information in relation to best use of the product considering latest clinical data. 
Spremenjen Povzetek glavnih značilnosti zdravila (SPC) in Navodila za uporabo vsebujeta posodobljene podatke o najboljši uporabi izdelka, upoštevajoč najnovejše klinične podatke.
The clinical issues were discussed with the MAH at the Vaccine Working Party (VWP) during its February 2006 meeting, while the quality issues were discussed at the February 2006 BWP meeting. 
Na zasedanju delovne skupine za cepiva (VWP) februarja 2006 je z imetnikom dovoljenja za promet obravnaval klinična vprašanja, medtem ko so vprašanja o kakovosti obravnavali na zasedanju delovne skupine za biotehnologijo (BWP) februarja 2006.
Considering all points raised, including time lines required to fully explore all issues related to low HepB immunogenicity following vaccination with HBVAXPRO and further to the assessment of the data provided by the MAH, the CHMP concluded that the MA of HBVAXPRO should be varied in accordance with Article 5(1) of Regulation (EC) No. 726/2004. 
Ob upoštevanju vseh različnih točk, vključno s časovno razporeditvijo, potrebno za pregled vseh vprašanj glede nizke imunogenosti HepB po cepljenju s HBVAXPRO, do ocene podatkov, ki jih je podal imetnik dovoljenja za promet, je CHMP zaključil, da mora biti dovoljenje za promet s cepivom HBVAXPRO spremenjeno v skladu s členom 5(1) Uredbe (ES) št. 726/2004.
Potential remaining risks will be minimised to an acceptable level by the fundamentally revised SPC. 
Bistveno spremenjen SPC bo ostala možna tveganja zmanjšal na sprejemljivo stopnjo.
The CHMP also considered the commitments given by the MAH in response to CHMP's requests to meticulously control the performance of HBVAXPRO from now on in a broad array of appropriate clinical trials including all age and risk categories. 
Prav tako je CHMP upošteval obljubo imetnika dovoljenja za promet, kot odgovor na prošnjo odbora CHMP, naj od sedaj dalje temeljito preverja delovanje cepiva HBVAXPRO v širokem spektru primernih kliničnih preizkušanj, vključno z vsemi starostnimi kategorijami in kategorijami tveganja.
In addition to the immunogenicity data generated in the past 5 years from clinical trials with the HBVAXPRO and PROCOMVAX data, the acceptable performance of these vaccines are supported from findings of surveillance for hepatitis B cases in the United States and New Zealand and from an analysis of the trend in vaccine failures reported to the MAH safety database. 
Poleg podatkov o imunogenosti, zbranih v zadnjih petih letih iz kliničnih preizkušanj s podatki cepiv HBVAXPRO in PROCOMVAX, je sprejemljivo delovanje teh cepiv podprto z ugotovitvami nadzora nad primeri hepatitisa B v ZDA in Novi Zelandiji ter iz analize trenda neuspešnega cepljenja, podanega varnostni podatkovni bazi imetnika dovoljenja za promet.
• The CHMP identified that the decreased immunogeniticy of the HepB component released by the MAH seems to be due to variability in the production process for this component and that following extensive review of the manufacturing process the MAH has identified the current adjuvantation process as a potential root cause for decreased immunogenicity of the HepB vaccine component. 
• CHMP je ugotovil, da je vzrok za zmanjšano imunogenost sestavine HepB, ki jo je izdal imetnik dovoljenja za promet, v spremenljivosti proizvodnega postopka za to sestavino in da je po temeljitem pregledu proizvodnega postopka imetnik dovoljenja za promet ugotovil, da je možni temeljni vzrok za zmanjšano imunogenost sestavine HepB cepiva sedanji pomožni postopek.
In their January 2006 plenary meeting, the CHMP confirmed their concerns regarding the decreasing immunogenicity of the recombinant Hep B component contained in HBVAXPRO and PROCOMVAX. 
Na plenarnem zasedanju januarja 2006 je CHMP potrdil svoje zadržke glede padajoče imunogenosti rekombinatne sestavine Hep B v cepivih HBVAXPRO in PROCOMAX.
The CHMP has recommended the variation of the Marketing Authorisations for HBVAXPRO in accordance with Article 5(2) of Regulation (EC) No. 726/2004. 
CHMP je priporočil spremembo dovoljenja za promet s cepivom HBVAXPRO v skladu s členom 5(2) Uredbe (ES) št. 726/2004.
In the studies conducted by the MAH to date with HBVAXPRO and Procomvax, seroprotective levels have been achieved in the large majority of vaccinees. 
V raziskavah cepiva HBVAXPRO in Procomvax, ki jih je do danes izvedel imetnik dovoljenja za promet, je bila v veliki večini cepiv dosežena zaščitna raven protiteles.
The CHMP reviewed all the technical and clinical data available for HBVAXPRO extensively. 
CHMP je temeljito pregledal vse tehnične in klinične podatke o cepivu HBVAXPRO.
The CHMP was requested to give an opinion as to whether the marketing authorisation for HBVAXPRO should be maintained, varied, suspended or withdrawn in the context of an Article 20 of Regulation (EC) No. 726/2004 procedure. 
Evropska komisija je prosila CHMP za mnenje o tem, ali naj dovoljenje za promet za cepivo HBVAXPRO ohrani, spremeni, ukine ali umakne v skladu s postopkom člena 20 Uredbe (ES) št. 726/2004.
The data reviewed by CHMP included data from 7 studies with HBVAXPRO and Procomvax, one of which is on-going at present. 
CHMP je pregledal podatke sedmih raziskav o cepivih HBVAXPRO in Procomvax, od katerih je ena še v teku.
This variability seems to be related to currently uncontrollable variances in the manufacturing process of the recombinant HepB vaccine component. 
Ta variabilnost se najverjetneje navezuje na odstopanja v proizvodnem postopku rekombinatne sestavine cepiva HepB, ki jih trenutno ni mogoče nadzorovati.
The CHMP requested the MAH to conduct studies regarding neonates, infants, older adults, renal dialysis patients, dose ranging and a booster study with the current formulation and the process upgraded product to further ensure that the vaccine provides a sufficient level of long-term protection against Hepatitis B. 
CHMP je prosil imetnika dovoljenja za promet, naj izvede raziskave o novorojenčkih, dojenčkih, starejših odraslih, bolnikih na ledvični dializi, raziskavo z razponom odmerkov in poživitveno raziskavo s trenutnim pripravkom ter s posodobljenim izdelkom, da bi dodatno zagotovila, da cepivo dolgoročno ščiti pred hepatitisom B.
Although in some of the trials conducted in the past 5 years, the GMTs of the hepatitis B vaccines were lower than responses observed in the early 1990's, the clinical data generated by the sponsor in the trials described above, demonstrate consistent, high anti-HBs seroprotective rates, which is the established correlate of effectiveness. 
Kljub temu, da so bili v nekaterih preizkušanjih, izvedenih v zadnjih petih letih, vrednosti GMT cepiv proti hepatitisu B nižje od odgovorov, opazovanih v začetku 90-ih let prejšnjega stoletja, so podatki, ki jih je v zgoraj omenjenih preizkušanjih zbral sponzor, pokazali visoke zaščitne ravni protiteles, kar je uveljavljena soodnosnost z učinkovitostjo.
In view of the lack of analytical tools to predict immunogenicity in man, the need for regular testing of recombinant HepB batches in clinical trials was considered, in order to ensure consistent high immunogenicity of HBVAXPRO produced in particular according to the new updated/improved process. 
Zaradi pomanjkanja analitičnih orodij za napoved imunogenosti pri človeku se je pojavila potreba po rednem testiranju serij rekombinantnega HepB v kliničnih preizkušanjih, z namenom zagotoviti nepretrgano visoko imunogenost cepiva HBVAXPRO, posebej izdelanega v skladu z novim/izboljšanim postopkom.
• Considering the data on low immunogenicity available today, the CHMP identified the need for further studies to ensure long-term protection against Hepatitis B with the current vaccine in future. 
• Ob upoštevanju danes dostopnih podatkov o nizki imunogenosti je CHMP, za zagotavljanje dolgoročne zaščite pred hepatitisom B s trenutnim cepivom tudi v prihodnosti, ugotovil potrebo po nadaljnjih raziskavah.
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION OF THE MARKETING AUTHORISATION OF HBVAXPRO PRESENTED BY THE EMEA 
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO DOVOLJENJA ZA PROMET Z ZDRAVILOM HBVAXPRO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
Concerns were expressed on the low immunogenicity of the HepB component of Hexavac and the potential consequences on long-term protection against Hepatitis B infection and boostability post primary course of vaccination with this vaccine. 
Izraženi so bili zadržki glede nizke imunogenosti sestavine HepB v cepivu Hexavac in možne posledice na dolgoročno zaščito pred okužbo s hepatitisom B ter na poživilne odmerke po zaključenem prvem programu cepljenja s tem cepivom.
The CHMP agreed with the MAH on revised product information for all presentations of HBVAXPRO, reflecting advice and suggestions made during the procedure. 
CHMP se z imetnikom dovoljenja za promet strinja o spremembah podatkov za vse oblike cepiva HBVAXPRO, v skladu z nasveti in predlogi, ki so se pojavili med postopkom.
The CHMP is of the Opinion that the Product Information of HBVAXPRO, should be varied in order to maintain the safe and effective clinical use for the following reasons: 
CHMP je mnenja, da morajo biti za ohranjanje varne in učinkovite klinične uporabe podatki o cepivu HBVAXPRO spremenjeni zaradi naslednjih razlogov:
Following the suspension of Hexavac due to reduced immunogenicity of the Hep B component in the vaccine, the MAH (Sanofi Pasteur MSD) was requested in September 2005 to provide further data and clarification on long-term immunological memory and protection against Hep B viral infection afforded by HBVAXPRO and PROCOMVAX, and the timelines of availability of further data. 
Septembra 2005 je bil imetnik dovoljenja za promet (Sanofi Pasteur MSD) po začasnem umiku cepiva Hexavac zaradi zmanjšane imunogenosti sestavine HepB v cepivu, zaprošen za nadaljnje podatke in obrazložitev o dolgoročnem imunološkem spominu ter zaščiti pred virusno okužbo s hepatitisom B, ki jo dajeta HBVAXPRO in PROCOMVAX, ter za časovno razporeditev dostopnosti nadaljnjih podatkov.