natgillin/translations-raw huggingface dataset:
The applicant presented data on experimental models with vaccines similar to Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics. 
Predlagatelj je predstavil podatke o poskusnih modelih s cepivi, podobnimi zdravilu Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
This is a summary of the European public assessment report (EPAR) for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
In one study involving 3,372 people, subjects were given either a seasonal flu vaccine followed by two doses of Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics three weeks apart, or a placebo (a dummy vaccine) followed by two doses of an adjuvanted seasonal vaccine three weeks apart. 
V eno študijo je bilo vključenih 3 372 preiskovancev, ki so prejeli cepivo proti sezonski gripi in čez tri tedne dva odmerka cepiva Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics ali pa placebo (cepivo brez zdravilne učinkovine) in čez tri tedne dva odmerka sezonskega cepiva z adjuvansom.
The CHMP decided that Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Odbor je zaključil, da so koristi zdravila Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The studies showed that overall Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics produced an antibody response that met these criteria. 
Študije so pokazale, da je na splošno zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics povzročilo odziv protiteles, ki izpolnjuje ta merila.
In the second study involving 240 people, subjects were given Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics using different vaccination schedules. 
V drugo študijo je bilo vključenih 240 preiskovancev, ki so prejeli cepivo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics po različnih režimih cepljenja.
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine for use in adults to protect against flu caused by the H5N1 (“bird flu”) strain of the influenza A virus. 
Zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics je cepivo za uporabo pri odraslih za zaščito pred gripo, ki jo povzroča sev H5N1 („ptičja gripa“) virusa gripe A. Cepivo se daje le v skladu z uradnimi priporočili.
The European Commission granted a marketing authorisation valid throughout the European Union for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics to Novartis Vaccines and Diagnostics S.r.l. 
Evropska komisija je dovoljenje za promet z zdravilom Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, veljavno po vsej Evropski uniji, odobrila podjetju Novartis Vaccines and Diagnostics S.r.l.
Other information about Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics 
Druge informacije o zdravilu Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a ‘prepandemic' vaccine. 
Zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics je „prepandemsko“ cepivo.
For the full list of all side effects reported with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, glejte navodilo za uporabo.
Two main studies provided data on vaccination with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics in healthy adults aged below and above 60 years. 
V okviru dveh glavnih študij so bili pridobljeni podatki o cepljenju zdravih odraslih, starih manj kot in več kot 60 let, z zdravilom Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
What benefit has Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics shown during the studies? 
Kakšne koristi je zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics izkazalo med študijami?
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine. 
Zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics je cepivo.
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 Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What is the risk associated with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics? 
Kakšna tveganja so povezana z zdravilom Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
What is Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics? 
Kaj je zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
Why has Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics been approved? 
Zakaj je bilo zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics odobreno?
How is Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics used? 
Kako se zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics uporablja?
How does Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics work? 
Kako zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics deluje?
The studies varied between 28 days and 13 months. 
Študije so trajale od 28 dni do 13 mesecev.
There are 5 different strengths of patch available: 12, 25, 50, 75 and 100 μg/h. 
Na voljo so obliži petih različnih jakosti: 12, 25, 50, 75 in 100 μg/h.
In these cases the benefits of such treatment should outweigh the risks (central nervous system depression and respiratory depression). 
V teh primerih morajo koristi takega zdravljenja odtehtati tveganja (depresija osrednjega živčevja in respiratorna depresija).
Durogesic (fentanyl) transdermal patches are registered nationally in the following 24 European Economic Area (EEA) countries: Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden and United Kingdom. 
Zdravilo Durogesic (fentanil) transdermalni obliži je nacionalno registriran v naslednjih 24 državah članicah Evropskega gospodarskega prostora (EGP): Avstrija, Belgija, Ciper, Češka, Danska, Finska, Francija, Grčija, Hrvaška, Irska, Islandija, Italija, Luksemburg, Madžarska, Malta, Nemčija, Nizozemska, Norveška,
Dose titration and maintenance therapy 
Titracija odmerka in vzdrževalno zdravljenje
The expected timeline of treatment is restricted to continuous and long-term opioid treatment of severe chronic pain. 
Pričakovani čas zdravljenja je omejen na stalno in dolgotrajno opioidno zdravljenje hude kronične bolečine.
The texts for the subsections absorption, distribution, biotransformation and excretion are considered acceptable. 
Kot sprejemljiva so bila ocenjena besedila podpoglavij o absorpciji, distribuciji, biotransformaciji in ekskreciji.
With respect to ‘Special Populations' the text based on the data are justified and were considered to be acceptable with some amendments. 
Kar se tiče „Posebnih populacij“, je besedilo, ki temelji na podatkih, upravičeno in z nekaj popravki sprejemljivo.
The proposed listing of most commonly reported adverse reactions from the pooled safety data was considered to be acceptable, with a minor amendment to improve the readability. 
Predlagani seznam najpogosteje poročanih neželenih učinkov iz zbranih varnostnih podatkov je bil ocenjen kot sprejemljiv, z manjšim popravkom za boljšo berljivost.
In addition, early patch replacement is only advised in the rare case of a problem with patch adhesion. 
Poleg tega se zgodnja zamenjava obliža svetuje le v redkem primeru težav z adhezijo obliža.
Paediatric indication 
Pediatrična indikacija
The new sub heading on linearity/non linearity is justified by adequate data and also considered to be acceptable. 
Novo podpoglavje o linearnosti/nelinearnosti upravičujejo zadostni podatki in se prav tako obravnava kot sprejemljivo.
The lowest available patch strength is 12.5 μg/h, which is designated as 12μg/h to distinguish it from a 125μg/h dosage that could be prescribed by using multiple patches. 
Najmanjša razpoložljiva jakost obliža je 12,5 µg/h, ki je označen kot 12 µg/h, da se lažje razlikuje od odmerka 125 µg/h, ki bi ga lahko predpisali z uporabo več obližev.
The transdermal patches were developed as a non-invasive parenteral treatment option to avoid the first pass mechanism and to achieve a constant release and plasma levels. 
Transdermalni obliži so bili razviti kot neinvaziven način parenteralnega zdravljenja, da bi se izognili mehanizmu prvega prehoda in da bi dosegli konstantno sproščanje in plazemsko koncentracijo.
Scientific conclusions 
ZNANSTVENI ZAKLJUČKI
For safety reasons, addition of the text that the lowest effective dose should be used has been included this subsection. 
Iz varnostnih razlogov je bilo v to podpoglavje dodano besedilo, da mora biti uporabljen najmanjši še učinkovit odmerek.
Since the term “intractable pain” is not properly defined, it has been replaced by ‘severe', which captures the term ‘intractable'. 
Ker izraz „neobvladljiva bolečina“ ni jasno opredeljen, ga je nadomestil izraz „hud“, ki obsega tudi pojem „neobvladljiv“.
Replacing the patch before 72 hours may result in increased serum concentrations of fentanyl, which could increase the risk for adverse events. 
Menjava obliža po manj kot 72 urah lahko povzroči povečanje serumske koncentracije fentanila, s čimer se poveča tveganje za neželene učinke.
The CHMP as a consequence, concluded that the benefit-risk balance of Durogesic and associated names remains favourable, subject to the agreed changes to the product information. 
Posledično je odbor CHMP zaključil, da je razmerje med tveganji in koristmi zdravila Durogesic in povezanih imen še naprej ugodno, pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu.
anaesthetic since the 1960s. 
Fentanil se kot intravenski anestetik trži od 60. let 20. stoletja.
The scope of this procedure is limited to Durogesic transdermal patches. 
Obseg tega postopka je omejen na zdravilo Durogesic transdermalni obliži.
Elderly or patients with renal or hepatic impairment should be closely observed and dose reductions made if necessary. 
Starejše bolnike in bolnike z okvaro ledvic ali jeter je treba natančno opazovati in po potrebi zmanjšati odmerke.
Table 3: An alternative conversion Table from oral morphine to fentanyl transdermal therapeutic system (TTS), based on data from a clinical study of fentanyl TTS in subjects tolerant of stable regimens of sustained release (SR) morphine, was proposed in 1996 by Donner et al. (1996)1. 
Preglednica 3: Alternativna preglednica za pretvorbo s peroralnega morfina na fentanilni transdermalni terapevtski sistem (TTS), osnovana na podatkih iz klinične študije fentanilnega TTS pri osebah, ki so razvile toleranco za stabilne sheme podaljšanega sproščanja morfina, je bila leta 1996 predlagana v Donner et al. (1996)1
In such a case it is recommended that the patient should be monitored closely for increased serum concentrations. 
V takem primeru se priporoča natančno nadzorovanje serumskih koncentracij zdravila pri bolniku.
Due to the divergent national decisions taken by Member States concerning the authorisation of Durogesic and associated names, the European Commission (EC) notified the European Medicines Agency of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the authorised summary of product characteristics (SmPCs) for the above-mentioned product, and thus to harmonise the SmPCs across the EU. 
Zaradi različnih nacionalnih odločitev, ki so jih sprejele države članice v zvezi z izdajo dovoljenja za promet z zdravilom Durogesic in povezanimi imeni, je Evropska komisija obvestilaEvropsko agencijo za zdravila o uradni napotitvi v skladu s členom 30 Direktive 2001/83/ES, z namenom odprave neskladij in uskladitve nacionalno odobrenih povzetkov glavnih značilnosti zdravila v EU.
The proposed wording has been developed to align the populations evaluated in clinical studies and to maintain alignment between the indications for both adult and paediatric patients. 
Predlagano besedilo je bilo zasnovano tako, da uskladi v kliničnih študijah vrednotene populacije in da ohrani usklajenost indikacij pri odraslih in pediatričnih bolnikih.
The analgesic action of fentanyl is thought to be mediated mainly through µopioid-receptors. 
Domneva se, da je analgetični učinek fentanila posredovan predvsem prek µ-opioidnih receptorjev.
Information related to studies in the post-operative pain indication in opioid naïve subjects has not been retained since this is not in the indication of Durogesic. 
Informacije, povezane s študijami pri indikaciji pooperacijske bolečine pri bolnikih, ki prej niso jemali opioidov, niso bile ohranjene, ker to ni vključeno v indikacijo o zdravilu Durogesic.
Fentanyl has high lipid solubility and potency, which make it suitable for transdermal administration. 
Fentanil ima visoko lipidotopnost in jakost, zaradi česar je primeren za transdermalno uporabo.
• The committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the Product Information. 
• Odbor je pregledal vse podatke, ki jih je v podporo predlagani uskladitvi informacij o zdravilu predložil imetnik dovoljenja za promet z zdravilom.
These are: pharmacodynamic-related interactions with centrally-acting medicinal products and alcohol, monoamine oxidase inhibitors, serotonergic drugs and concomitant use of mixed opioid agonists/antagonists, and pharmacokinetic-related interactions with CYP3A4 Inhibitors and CYP3A4 inducers. 
Te so: s farmakodinamiko povezane interakcije s centralno delujočimi zdravili in alkoholom, zaviralci monoaminske oksidaze, serotonergična zdravila ter hkratno uporabo mešanih opioidnih agonistov/antagonistov in s farmakokinetiko povezane interakcije z zaviralci CYP3A4 in induktorji CYP3A4.
If hypotension persists after naloxone administration, standard medical care for hypovolemia, including fluid management is recommended to be considered. 
Če hipotenzija vztraja po aplikaciji naloksona, se priporoča premislek o priporočeni standardni medicinski oskrbi pri hipovolemiji, vključno s tekočinskim zdravljenjem.
The MAH has clarified that only at first application could a patch be replaced after 48 hours when analgesia is insufficient. 
Imetnik dovoljenja za promet z zdravilom je pojasnil, da bi se obliž lahko zamenjal po 48 urah le v primeru nezadostne analgezije pri uporabi prvega odmerka.
Durogesic transdermal patch contains fentanyl, which is a potent, synthetic opioid analgesic belonging to the piperidine derivatives. 
Zdravilo Durogesic transdermalni obliž vsebuje fentanil, ki je močan sintetični opioidni analgetik iz skupine piperidinskih derivatov.
Table 2: Designed for adult patients who have a need for rotation of, or conversion from, another opioid regimen (conversion ratio of oral morphine to transdermal fentanyl approximately equal to 150:1). 
Preglednica 2: Zasnovana za odrasle bolnike, ki potrebujejo spremembo ali pretvorbo z drugega opioidnega načina zdravljenja (s pretvorbenim razmerjem peroralnega morfina in transdermalnega fentanila približno enakim 150 : 1).
Other warnings included in section 4.4 are: chronic pulmonary disease, drug dependence and potential for abuse, central nervous system including increased intracranial pressure, cardiac disease, hypotension, hepatic impairment, renal impairment, respiratory depression, serotonin syndrome, accidental exposure by patch transfer, use in elderly patients, gastrointestinal tract, paediatric population, lactation, and patients with myasthenia gravis. 
Druga v poglavje 4.4 vključena opozorila so: kronična pljučna bolezen, zasvojenost z zdravilom in možnost zlorabe, osrednje živčevje, vključno z zvišanim intrakranialnim tlakom, bolezni srca, hipotenzija, okvara jeter, okvara ledvic, respiratorna depresija, serotoninski sindrom, naključna izpostavljenost s prenosom obliža, uporaba pri starejših bolnikih, prebavila, pediatrična populacija, laktacija in bolniki z miastenijo gravis.
Table 1 - Equianalgesic potency conversion: Due to differences in the relative potency of various opioid analgesics, guidance is necessary regarding equianalgesic doses of various medications. 
Preglednica 1 - Pretvorba v odgovarjajoč analgetični učinek: Zaradi razlik v relativni učinkovitosti različnih opioidnih analgetikov je potrebna usmeritev o odgovarjajočih odmerkih različnih zdravil.
As the wording about the potential risk of serotonin syndrome has been included in sections 4.4 and 4.5 of the harmonised SmPC, section 4.8 of the harmonised SmPC has also been updated with a statement that cases of serotonin syndrome have been reported when fentanyl-containing products are administered concomitantly with highly serotonergic medicinal products. 
Ker je bilo v poglavji 4.4 in 4.5 usklajenega povzetka glavnih značilnosti zdravila vključeno besedilo o možnem tveganju za serotoninski sindrom, je bil razdelek 4.8 usklajenega povzetka glavnih značilnostih zdravila posodobljen z izjavo, da so pri hkratnem dajanju zdravil, ki vsebujejo fentanil, in visoko serotonergičnih zdravil poročali o primerih serotoninskega sindroma.
The subjects (N=1667) included had chronic low back pain, osteoarthritis or rheumatoid arthritis or pain of unspecified origin. 
V študijo so bile vključene osebe (N = 1 667), ki so imele kronične bolečine v križu, osteoartrozo, revmatoidni artritis ali bolečino neopredeljenega izvora.
Because there are no pharmacokinetic (PK) data available to support the safety of replacing patches at 48hour intervals, the MAH does not recommend dosing intervals of less than 72 hours. 
Na voljo ni nobenih farmakokinetičnih podatkov, ki bi podprli varnost menjavanja obližev v 48-urnih intervalih, zato imetnik dovoljenja za promet z zdravilom ne priporoča intervalov odmerjanja, krajših od 72 ur.
With regard to the interactions with CYP3A4 inhibitors, although the concomitant use with Durogesic is not recommended, in cases where the benefits outweigh the increased risk of adverse effects, a washout period of 2 days before the first Durogesic patch is applied was considered to be sufficient in most cases. 
Kar se tiče interakcij z zaviralci CYP3A4, hkratna uporaba z zdravilom Durogesic ni priporočena, v tistih primerih, kjer koristi odtehtajo povečano tveganje za neželene učinke, pa se je štelo za zadostno obdobje izpiranja dva dni pred uporabo prvega obliža Durogesic.
As outlined in the October 2007 Public Assessment Report regarding paediatric data, the long-term management of severe chronic pain in children from 2 years of age who are receiving opioid therapy is indicated in section 4.1 of the proposed harmonised SmPC, and also present in the majority of SmPCs. 
Kot je bilo v zvezi s pediatričnimi podatki opisano v javnem poročilu o oceni zdravila oktobra 2007, je dolgotrajno zdravljenje hude kronične bolečine pri otrocih, starih dve ali več let, ki prejemajo opioidno zdravljenje, indicirano v poglavju 4.1 predlaganega usklajenega povzetka glavnih značilnosti zdravila in zapisano tudi v večini povzetkov glavnih značilnosti zdravila.
In such cases, the potential for life-threatening hypoventilation has been added as a warning. 
Zaradi takih primerov je bilo dodano opozorilo o možnosti življenjsko nevarne hipoventilacije.
As there were no striking differences in the safety profile between adult and paediatric subjects, the MAH's decision not to include a separate table was considered to be acceptable. 
Ker v informaciji o varnosti zdravila ni bilo bistvenih razlik med odraslimi in pediatričnimi preiskovanci, je bila odločitev imetnika dovoljenja za promet z zdravilom, da ne vključi ločene preglednice, ocenjena kot sprejemljiva.
The results of all pharmacodynamic or efficacy studies conducted in paediatric patients has been included in this section and the number of paediatric patients has been brought in line with the other sections of the harmonised SmPC. 
V ta razdelek so bili vključeni rezultati vseh farmakodinamičnih študij in študij o učinkovitosti, ki so bile izvedene pri pediatričnih bolnikih, število pediatričnih bolnikov pa je bilo usklajeno z drugimi poglavji usklajenega povzetka glavnih značilnosti zdravila.
Major differences between SmPCs regarding the assigned frequencies for individual adverse reactions were discussed and resolved. 
Obravnavane in odpravljene so bile glavne razlike med povzetki glavnih značilnosti zdravila v zvezi s pripisanimi pogostostmi posameznih neželenih učinkov.
The wording regarding tolerance and dependence, opioid withdrawal symptoms, and neonatal withdrawal syndrome follow exactly the wording included in the CSP and is considered to be acceptable. 
Besedilo o toleranci in zasvojenosti, simptomih odtegnitve opioidov in neonatalnem odtegnitvenem sindromu natančno sledijo besedilu v ključni informaciji o zdravilu in so obravnavane kot sprejemljive.