natgillin/translations-raw huggingface dataset:
The Agency also considered that, if given before a liver transplant, Sovaldi in combination with ribavirin can prevent re-infection of the liver, which in the absence of treatment occurs nearly always and results in a poor prognosis. 
Agencija je prav tako menila, da lahko dajanje zdravila Sovaldi v kombinaciji z ribavirinom pred presaditvijo jeter prepreči ponovno okužbo jeter, ki se brez zdravljenja pojavi skoraj vedno in prispeva k slabi prognozi.
The active substance in Sovaldi, sofosbuvir, blocks the action of a protein called ‘NS5B RNA-dependent RNA polymerase' in the hepatitis C virus, which is essential for the virus to multiply. 
Učinkovina v zdravilu Sovaldi, sofosbuvir, zavira delovanje beljakovine, imenovane „RNK-polimeraza NS5B, odvisna od RNK“, v virusu hepatitisa C, ki ima ključno vlogo pri razmnoževanju virusa.
Sovaldi is being investigated in one main study in children and adolescents aged between 3 and 18 years infected with hepatitis C virus genotypes 2 or 3. 
Zdravilo Sovaldi trenutno proučujejo v eni glavni študiji, v katero so vključeni otroci in mladostniki, stari od 3 do 18 let, ki so okuženi z virusom hepatitisa C genotipa 2 ali 3.
Sovaldi has been investigated in four main studies involving a total of 1,305 adult patients infected with hepatitis C. In all four studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 12 weeks after the end of treatment. 
Zdravilo Sovaldi so proučevali v štirih glavnih študijah, v katere je bilo skupaj vključenih 1 305 odraslih bolnikov, okuženih s hepatitisom C. V vseh štirih študijah je bilo glavno merilo učinkovitosti število bolnikov, pri katerih krvne preiskave 12 tednov po koncu zdravljenja niso pokazale nobenih znakov virusa hepatitisa C.
Sovaldi contains the active substance sofosbuvir. 
Zdravilo Sovaldi vsebuje učinkovino sofosbuvir.
Sovaldi must be used in combination with other medicines used to treat chronic hepatitis C, such as ribavirin or peginterferon alfa and ribavirin. 
Zdravilo Sovaldi se mora uporabljati v kombinaciji z drugimi zdravili za zdravljenje kroničnega hepatitisa C, na primer z ribavirinom ali s peginterferonom alfa in ribavirinom.
Additional studies showed that Sovaldi in combination with ribavirin decreased the risk of infection of the new liver with hepatitis C virus in adult patients undergoing transplantation, that Sovaldi is also effective in patients infected with both hepatitis C and HIV, and that the outcome of patients with genotype 3 infection could be improved by extending treatment to 24 weeks. 
Dodatne študije so pokazale še, da zdravilo Sovaldi v kombinaciji z ribavirinom zmanjša tveganje za okužbo presajenih jeter z virusom hepatitisa C pri odraslih bolnikih, pri katerih je bila opravljena presaditev, da je zdravilo Sovaldi učinkovito tudi pri odraslih bolnikih, okuženih s hepatitisom C in virusom HIV, ter da je pri bolnikih z okužbo z virusom genotipa 3 mogoče izboljšati izid, če se zdravljenje podaljša na 24 tednov.
Sovaldi is an antiviral medicine used in combination with other medicines to treat adults and children from 12 years of age with chronic (long-term) hepatitis C, an infection caused by the hepatitis C virus that affects the liver. 
Zdravilo Sovaldi je protivirusno zdravilo, ki se uporablja v kombinaciji z drugimi zdravili za zdravljenje odraslih in otrok od 12. leta naprej s kroničnim (dolgotrajnim) hepatitisom C, tj. okužbo, ki jo povzroča virus hepatitisa C, ki prizadene jetra.
Sovaldi can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C. 
Predpisovanje in izdaja zdravila Sovaldi je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov s kroničnim hepatitisom C.
The most common side effects with Sovaldi in combination with ribavirin and peginterferon alfa were similar to those commonly reported with ribavirin or peginterferon alfa and included fatigue (tiredness), headache, nausea (feeling sick) and insomnia (difficulty sleeping). 
Najpogostejši neželeni učinki zdravila Sovaldi v kombinaciji z ribavirinom in peginterferonom alfa so bili podobni tistim, o katerih so pogosto poročali pri uporabi ribavirina ali peginterferona alfa, ter so vključevali utrujenost, glavobol, navzejo (slabost) in nespečnost.
Patients infected with hepatitis C virus of genotype 2 received Sovaldi with ribavirin for 12 weeks and those infected with genotype 3 received the combination for 24 weeks. 
Bolniki, okuženi z virusom hepatitisa C genotipa 2, so zdravilo Sovaldi prejemali v kombinaciji z ribavirinom 12 tednov, tisti, okuženi z genotipom 3, pa so kombinacijo prejemali 24 tednov.
This study investigated 12 weeks of treatment with Sovaldi and ribavirin compared with placebo (a dummy treatment) and found that 78% (161 out of 207) of patients taking Sovaldi and ribavirin had no sign of the hepatitis C virus 12 weeks after the end of treatment, whereas none of 71 patients taking placebo were free of the virus. 
V tej študiji so 12-tedensko zdravljenje z zdravilom Sovaldi in ribavirinom primerjali s placebom (zdravilom brez učinkovine) ter ugotovili, da 12 tednov po končanem zdravljenju pri 78 % (161 od 207) bolnikov, ki so jemali zdravilo Sovaldi in ribavirin, ni bilo znakov virusa hepatitisa C, medtem ko so v skupini, ki je prejemala placebo, virus našli pri vseh 71 bolnikih.
• St. John's wort (a herbal preparation used to treat depression and anxiety); 
• šentjanževko (rastlinski pripravek za zdravljenje depresije in tesnobe);
• The second study involved 499 previously untreated patients who had hepatitis C of genotypes 2 or 3. 
• V drugi študiji je sodelovalo 499 bolnikov, ki se predhodno še niso zdravili in so imeli hepatitis C genotipa 2 ali 3.
• The fourth study involved 201 patients with hepatitis C virus (genotypes 2 or 3) whose infection did not improve on previous treatment with interferon or whose infections came back. 
• Četrta študija je vključevala 201 bolnika z virusom hepatitisa C (genotipa 2 ali 3), pri katerem se okužba ni izboljšala glede na predhodno zdravljenje z interferonom ali pa se je ponovno pojavila.
• The third study involved 278 patients with genotypes 2 or 3 hepatitis C virus who could not take or did not want to have treatment with interferon. 
• Tretjo študijo so opravili na 278 bolnikih z virusom hepatitisa C genotipa 2 ali 3, ki se niso mogli ali se niso želeli zdraviti z interferonom.
The company that markets Sovaldi will carry out a study in patients who have had liver cancer to evaluate the risk of the cancer returning after treatment with direct-acting antivirals such as Sovaldi. 
Družba, ki trži zdravilo Sovaldi, bo za oceno tveganja ponovitve raka jeter po zdravljenju z neposredno delujočimi protivirusnimi zdravili, kot je zdravilo Sovaldi, izvedla študijo pri bolnikih, ki so preboleli raka jeter.
In this study, patients given Sovaldi together with ribavirin for 12 weeks were compared with patients given peginterferon alfa and ribavirin for 24 weeks. 
V tej študiji so bolnike, ki so 12 tednov prejemali zdravilo Sovaldi v kombinaciji z ribavirinom, primerjali z bolniki, ki so 24 tednov prejemali peginterferon alfa in ribavirin.
How does Sovaldi work? 
Kako zdravilo Sovaldi deluje?
In this study, 50% (51 out of 103) of patients taking Sovaldi and ribavirin for 12 weeks had no sign of the hepatitis C virus, compared with 71% (70 out of 98) of patients treated for 16 weeks. 
V študiji niso ugotovili znakov virusa hepatitisa C pri 50 % (51 od 103) bolnikov, ki so zdravilo Sovaldi in ribavirin jemali 12 tednov, v primerjavi z 71% (70 od 98) bolnikov, ki so zdravili jemali 16 tednov.
In this study, 91% (296 out of 327) of patients had no sign of the virus 12 weeks after the end of treatment. 
V tej študiji 12 tednov po končanem zdravljenju pri 91 % (296 od 327) bolnikov ni bilo znakov virusa hepatitisa C.
This study compared Sovaldi and ribavirin taken for 12 weeks with Sovaldi and ribavirin taken for 16 weeks. 
V tej študiji so zdravilo Sovaldi in ribavirin, ki so ju bolniki jemali 12 tednov, primerjali z zdravilom Sovaldi in ribavirinom, ki so ju bolniki jemali 16 tednov.
How is Sovaldi used? 
Kako se zdravilo Sovaldi uporablja?
For the full list of side effects of Sovaldi, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Sovaldi, glejte navodilo za uporabo.
The duration of treatment will depend on the genotype of the virus the patient is infected with and on which medicines are used with Sovaldi. 
Uporablja se lahko pri vseh šestih različicah (genotipih) virusa hepatitisa C. Trajanje zdravljenja je odvisno od genotipa virusa, s katerim je bolnik okužen, in od tega, katera zdravila se uporabljajo v kombinaciji z zdravilom Sovaldi.
• The first study involved 327 previously untreated patients who were infected with hepatitis C virus of genotypes 1, 4, 5 or 6, and who were given Sovaldi together with two other antiviral medicines, 
• V prvi študiji je sodelovalo 327 predhodno nezdravljenih bolnikov, okuženih z virusom hepatitisa C genotipa 1, 4, 5 ali 6, ki so 12 tednov prejemali zdravilo Sovaldi v kombinaciji z dvema drugima protivirusnima zdraviloma, peginterferonom alfa in ribavirinom.
And if yes, what kind of non-clinical studies shall be performed? 
Če je odgovor pritrdilen, kakšno vrsto nekliničnih študij je treba izvesti?
The procedure was therefore referred to the CHMP in October 2008. 
Zaradi tega je bil postopek oktobra 2008 predložen odboru CHMP.
It has been marketed since 1979, for intramuscular use. 
Zdravilo je v prometu od leta 1979, in sicer za intramuskularno uporabo.
The Applicant also provided exposure data, stating that a total of about 143,589 injections were given to patients. 
Predlagatelj je predložil tudi podatke o izpostavljenosti, v katerih je navedeno, da so bolniki prejeli vsega skupaj približno 143 589 injekcij.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF UMAN BIG 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA UMAN BIG
Limited cases of nausea, vomiting, hypotension, tachycardia, allergic or anaphylactic reactions have also been reported. 
Poročali so tudi o omejenem številu primerov slabosti, bruhanja, hipotenzije, tahikardije, alergičnih ali anafilaktičnih reakcij.
According to the Applicant, the characteristics of the product, the available safety data, and the overall safety system in place do not warrant any recommendations for further risk minimisation activities. 
Po mnenju predlagatelja, lastnosti zdravila, razpoložljivi varnostni podatki in celotni varnostni sistem ne upravičujejo nobenih priporočil glede nadaljnjih ukrepov za zmanjšanje tveganja.
Therefore, the CHMP is of the opinion that the benefit/risk balance of the product can be considered to be positive and that the product is approvable. 
Zaradi tega odbor CHMP meni, da se lahko razmerje med koristmi in tveganji za zdravilo upošteva kot pozitivno in da se lahko zdravilo odobri.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATE 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Although the Reference Member State concluded that the objections raised had been resolved, the Objecting Concerned Member State was still of the opinion that a potential serious risk to public health was identified for this particular product, with regards to safety and efficacy. 
Čeprav je referenčna država članica zaključila, da so bili zadržki odpravljeni rešeni, je ugovarjajoča zadevna država članica še vedno menila, da so za to zdravilo odkrili morebitno resno tveganje za javno zdravje v zvezi z varnostjo in učinkovitostjo.
The CHMP fully endorses the development of a combined Guideline on specific immunoglobulins, in order to harmonise the requirements for granting marketing authorization. 
CHMP v celoti podpira razvoj kombinirane smernice za specifične imunoglobuline, da bi uskladil zahteve za odobritev dovoljenja za promet z zdravilom.
Content (concentration) 
Vsebina koncentracija
Levels of antibodies of ≥100IU/ml were achieved. 
Dosegli so ravni protiteles, ki so znašale ≥ 100 ME/ml.
Summary of the report from the BPWP and CHMP position: 
Povzetek poročila Delovne skupine za krvne proizvode in stališče odbora CHMP:
The Applicant provided a summary of the available post-marketing experience data for both UMAN BIG and IMMUNOHBs (a different brand name an identical product with the same pack sizes and concentration, produced by the same manufacturing sites, using the same manufacturing process), indicating that approximately 143,381,160 IU of IMMUNOHBs and approximately 11,695,680 IU of UMAN BIG have been sold worldwide between June 1995 and December 2007. 
Predlagatelj je predložil povzetek razpoložljivih podatkov o izkušnjah po izdaji dovoljenja za promet za zdravilo UMAN BIG in zdravila IMMUNOHB (druga trgovska znamka enakega zdravila z enakimi velikostmi pakiranja in koncentracijo, ki ga proizvajajo isti proizvodni obrati po istem proizvodnem postopku) kažejo, da je bilo med junijem 1995 in decembrom 2007 po svetu prodanih približno 143 381 160 ME zdravil IMMUNOHB in približno 11 695 680 ME zdravila UMAN BIG.
The application for UMAN BIG 180 IU/ml solution for injection was submitted through the Mutual Recognition Procedure, on the basis of the marketing authorisation granted by the RMS (Italy) on the 2nd of June 1979. 
Vloga za zdravilo UMAN BIG 180 ME/ml raztopina za injiciranje je bila predložena v postopku medsebojnega priznavanja na podlagi dovoljenja za promet z zdravilom, ki ga je odobrila referenčna država članica (Italija) dne 2. junija 1979.
The Applicant concluded that no new information on tolerability is available to suggest a modification of the safety profile of UMAN BIG. 
Predlagatelj je zaključil, da ni na voljo novih podatkov o prenašanju zdravila, ki bi kazali na spremembo varnostnega profila zdravila UMAN BIG.
The CHMP considered that based on the 28 years of clinical experience with the existing formulation of UMAN BIG, the safety in humans can be considered to have been extensively assessed. 
Odbor CHMP je menil, da se lahko na podlagi 28 let kliničnih izkušenj z obstoječo formulacijo zdravila UMAN BIG privzame, da je bila varnost pri ljudeh obsežno ovrednotena.
In conclusion, the CHMP sought advice from the Blood Products Working Party on the four questions raised for discussion and noted the positive recommendation in favour of UMAN BIG expressed by the BPWP in a report dated 27 November 2008. 
Na koncu je odbor CHMP za nasvet o štirih vprašanjih za razpravo prosil Delovno skupino za krvne proizvode in upošteval pozitivno priporočilo v prid zdravilu UMAN BIG, ki ga je v poročilu z dne 27. novembra 2008 podala Delovna skupina za krvne proizvode.
The Applicant also demonstrated the impossibility to perform any clinical study in any of the populations included in the indication, apart from newborns, after the introduction of the vaccination. 
Predlagatelj je prav tako dokazal, da po uvedbi cepljenja ni mogoče izvesti nobene klinične študije v kateri koli populaciji, vključeni v indikacijo, razen novorojenčkov.
UMAN BIG contains glycine as the excipient, a natural amino acid and therefore not expected to cause any problems. 
Zdravilo UMAN BIG vsebuje kot pomožno snov glicin, naravno aminokislino, zaradi česar ni pričakovati povzročanja težav.
The Applicant stated that the only relevant measure of efficacy for this kind of product is the level of protective anti-HBs achieved in the plasma, since after the introduction of vaccination it is no longer feasible to assess the efficacy of the product on the basis of the incidence of new infections. 
Predlagatelj je navedel, da je edino pomembno merilo učinkovitosti za to vrsto zdravil raven zaščitnih protiteles proti površinskemu antigenu virusa hepatitisa B, ki se doseže v plazmi, saj po uvajanju cepljenja ni več mogoče ovrednotiti učinkovitosti zdravila na podlagi pojavnosti novih okužb.
The PK behaviour, especially in terms of half life of the anti HB antibodies and maintenance of a protective antibody level titre can be considered as an acceptable surrogate marker of efficacy. 
Farmakokinetično obnašanje, še posebno z vidika razpolovne dobe protiteles proti hepatitisu B in ohranjanja zaščitnega titra protiteles, se lahko upošteva kot sprejemljiv nadomestni označevalec učinkovitosti.
Does the BPWP consider necessary the development of a specific Note for Guidance on the Clinical Investigation of Human Plasma derived Hepatitis-B Immunoglobulins to outline requirements particularly with regard to the design of the clinical studies and the required safety data for the claimed indications? 
Ali Delovna skupina za krvne proizvode meni, da je treba sestaviti posebno opombo za smernice o kliničnem preiskovanju imunoglobulinov proti hepatitisu B, pridobljenih iz človeške plazme, da bi začrtali zahteve, še posebej glede zasnove kliničnih študij in potrebnih varnostnih podatkov za zahtevane indikacije?
Is a single PK study conducted in a population and dose regimen different from the one intended for the Marketing Authorisation adequate and sufficient to support efficacy in all indications foreseen in the European core SPC for immunoglobulins, with no specific efficacy clinical trial? 
Ali sta ena sama farmakokinetična študija v populaciji in shema odmerjanja, ki je drugačna od tiste v dovoljenju za promet z zdravilom, primerna in zadostna za podporo učinkovitosti vseh predvidenih indikacij v evropskem temeljnem povzetku glavnih značilnosti zdravila za imunoglobuline, ne da bi bila pri tem potrebna specifična klinična preizkušanja učinkovitosti?
A literature search on specific immunoglobulins for intramuscular administration has shown, in general, a satisfactory profile of tolerability and safety, even if mild to moderate adverse events have been observed. 
Iskanje po literaturi o specifičnih imunoglobulinih za intramuskularno dajanje je v glavnem pokazalo zadovoljiv profil prenašanja in varnosti, tudi kadar so opazili blage do zmerne neželene učinke.
Therefore, the CHMP was of the opinion that the submitted post marketing safety data are adequate to assess the safety profile of the product, even if they originate from a single EU member state. 
Odbor CHMP je zaradi tega menil, da predlagani podatki o varnosti zdravila po izdaji dovoljenja za promet zadostujejo za ovrednotenje varnostnega profila zdravila, tudi če izvirajo iz ene same države članice EU.
The BPWP considered that data from pre-clinical studies do not provide any additional information concerning the actual immunoglobulin and that often, data on the excipients are necessary. 
Delovna skupina za krvne proizvode je menila, da podatki iz predkliničnih študij ne dajejo dodatnih informacij glede dejanskega imunoglobulina in da so pogosto potrebni podatki o pomožnih snoveh.
Whereas - the CHMP considered that the post marketing safety data submitted are adequate to establish the positive safety profile of UMAN BIG, - the CHMP considered the efficacy profile of UMAN BIG to be satisfactory for the indications applied for in the SPC, - the CHMP considered that the benefit/risk of UMAN BIG is positive, the CHMP has recommended the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination Group procedure as mentioned in Annex III for UMAN BIG. 
Ob upoštevanju, da: - je CHMP menil, da predloženi podatki o varnosti zdravila po izdaji dovoljenja za promet zadostujejo za ugotovitev pozitivnega varnostnega profila zdravila UMAN BIG, - je CHMP menil, da je profil učinkovitosti zdravila UMAN BIG zadovoljiv za indikacije, ki so navedene v povzetku glavnih značilnosti zdravila, - je CHMP menil, da je razmerje med koristmi in tveganji za zdravilo UMAN BIG pozitivno, je CHMP priporočil odobritev dovoljenja za promet z zdravilom, katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostanejo enaki kot končne različice, dogovorjene med postopkom Usklajevalne skupine, kakor je omenjeno v Dodatku III za zdravilo UMAN BIG.
The PK KB-036 study demonstrates that the anti-HBsAg antibodies in UMAN BIG maintain the kinetic profile of the natural antibodies and that the entire production process does not affect their characteristics or the integrity of the immunoglobulin molecule and therefore does not alter the biological response. 
Farmakokinetična študija KB-036 kaže, da protitelesa proti površinskemu antigenu virusa hepatitisa B v zdravilu UMAN BIG ohranjajo kinetični profil naravnih protiteles in da celotni postopek proizvodnje ne vpliva na njihove lastnosti ali celovitost imunoglobulinske molekule ter zato ne spremeni biološkega odziva.
Moreover, the potential risk of transmitting infective agents through administration of anti hepatitis B immunoglobulins is only theoretical due to the state of the art knowledge and procedures for quality control. 
Poleg tega je tveganje morebitnega prenosa kužnih povzročiteljev z dajanjem imunoglobulinov proti virusu hepatitisa B zaradi vrhunskega znanja in postopkov za nadzorovanje kakovosti samo teoretično.
Following the referral to the CHMP, the Committee noted the position of the RMS and the objecting CMS and decided to adopt a List of Questions addressed to the Blood Products Working Party (BPWP), in order to receive the view of the working party, on both specific issues related to this specific product and on issues related to immunoglobulins in general. 
Po napotitvi zadeve odboru CHMP je Odbor upošteval stališči referenčne države članice in ugovarjajoče zadevne države članice ter se odločil, da sprejme seznam vprašanj, ki ga je predal Delovni skupini za krvne proizvode, da bi mu ta podala svoje stališče glede točno določenih vprašanj, ki se nanašajo na to zdravilo, in glede vprašanj, ki se nanašajo na imunoglobuline na splošno.
Are Post Marketing Safety (PMS) data generated in only one EU country adequate to define the safety profile of the product? 
Ali so podatki o varnosti po izdaji dovoljenja za promet, pridobljeni iz samo ene države EU, zadostni za opredelitev varnostnega profila zdravila?
Literature references show also that the pharmacokinetic profile of UMAN BIG is comparable to that of other intramuscular Hepatitis B immunoglobulin products. 
Reference iz literature kažejo tudi, da je farmakokinetični profil zdravila UMAN BIG primerljiv s profilom drugih intramuskularnih imunoglubulinskih zdravil proti hepatitisu B.
More than 1,000 Italian newborns included in the studies (published between 1983 and 2001) received UMAN BIG and the dose regimen and protective threshold (10 mIU/ml) are consistent with the provisions of the current core SPC and proposed SPC. 
Zdravilo UMAN BIG je prejelo več kot 1 000 italijanskih novorojenčkov, vključenih v študije (objavljene med letoma 1983 in 2001), shema odmerjanja in zaščitni prag (10 m ME/ml) pa sta skladni z določili v trenutno veljavnem temeljnem povzetku glavnih značilnosti zdravila ter predlaganem povzetku glavnih značilnosti zdravila.
The study was performed in different populations and in much higher posology than recommended in the relevant core SPC because the Applicant considered that the indications, posology and pharmacokinetic information reported in the core SPC are not product specific, but rather that they apply to products complying with the relative European Pharmacopoeia monograph, such as UMAN BIG. 
Študijo so izvedli v različnih populacijah in pri veliko večjem odmerjanju, kot je bilo priporočeno v ustreznem temeljnem povzetku glavnih značilnosti zdravila, ker je predlagatelj menil, da se indikacije, odmerjanje in podatki o farmakokinetiki, navedeni v temeljnem povzetku glavnih značilnosti zdravila, ne nanašajo posebej na to zdravilo, temveč na zdravila, ki so skladna z ustreznimi monografijami Evropske farmakopeje, kot je zdravilo UMAN BIG.