natgillin/translations-raw huggingface dataset:
• Taking into account that these medicinal products are only used to treat benign symptoms, the PRAC considered that no feasible and proportionate measures would effectively allow identifying patients with risk factors for QT prolongation and TdP, and that therefore any related risk minimisation measures could not be implemented in clinical practice. 
• ob upoštevanju dejstva, da se ta zdravila uporabljajo le za zdravljenje benignih simptomov, je odbor PRAC sklenil, da nobeni izvedljivi in sorazmerni ukrepi ne bi učinkovito omogočali določanja bolnikov, pri katerih so prisotni dejavniki tveganja za podaljšanje intervala QT in TdP, ter da zato v klinični praksi ni mogoče uvesti nobenih s tem povezanih ukrepov za zmanjševanje tveganja.
Fenspiride-containing medicinal products are authorised nationally for the treatment of symptoms (e.g. cough and expectoration) related to bronchopulmonary diseases. 
Zdravila, ki vsebujejo fenspirid, so bila odobrena po nacionalnih postopkih za zdravljenje simptomov (npr. kašlja in izkašljevanja), povezanih z bronhopulmonarnimi boleznimi.
• The PRAC reviewed the totality of the data available for fenspiride-containing medicinal products in relation to the risk of QT prolongation. 
• odbor PRAC je pregledal vse razpoložljive podatke za zdravila, ki vsebujejo fenspirid, v zvezi s tveganjem podaljšanja intervala QT.
There is a possibility that the IC50 value is overestimated (i.e. experiments performed at room temperature, external K+ concentration in the milieu unknown, no DMSO cells perfusion before adding fenspiride in DMSO yet substracting DMSO effect) and fenspiride could be a more potent blocker of hERG channels than shown in vitro. 
Obstaja možnost, da je vrednost IC50 precenjena (tj. da so bili poskusi izvedeni pri sobni temperaturi, da je bila zunanja koncentracija K+ v okolju neznana, da pred dodajanjem fenspirida v DMSO celice niso bile perfundirane, odštet pa je bil učinek DMSO) in da je fenspirid močnejši zaviralec kanalčkov hERG, kot je dokazano in vitro.
The calculated safety margins between the hERG IC50 obtained and the effective therapeutic plasma concentration for fenspiride, was below the lowest acceptable safety margin proposed in the literature (between 6 and 26, depending on the pharmaceutical form/dose administered and on the administration schedule). 
Izračunane varnostne meje med pridobljeno vrednostjo IC50 kanalčka hERG in učinkovito terapevtsko plazemsko koncentracijo za fenspirid so bile nižje od najnižje sprejemljive varnostne meje, predlagane v literaturi (med 6 in 26, odvisno od farmacevtske oblike/danega odmerka in sheme dajanja).
QT prolongation and TdP are unpredictable and potentially life-threatening conditions that constitute a major safety concern, particularly given the benign symptoms for which fenspiride-containing medicinal products are used to treat. 
Podaljšanje intervala QT in TdP sta nepredvidljivi in potencialno življenje ogrožajoči stanji, ki pomenita resen varnostni pomislek, še posebno glede na benigne simptome, za zdravljenje katerih se uporabljajo zdravila, ki vsebujejo fenspirid;
Calculated safety margins between the hERG inhibition concentration and the effective therapeutic plasma concentration were below the lowest acceptable margin proposed in the literature for administration in humans. 
Izračunane varnostne meje med koncentracijo zaviranja kanalčka hERG in učinkovito terapevtsko plazemsko koncentracijo so bile nižje od najnižje sprejemljive meje, ki je v literaturi predlagana za uporabo pri ljudeh.
It has also been shown in a recent ex vivo study on isolated guinea pig hearts that the hERG blockade exerted by fenspiride may translate into QT prolongation in a similar concentration range as observed in the hERG study. 
V nedavni študiji izoliranih src morskih prašičkov ex vivo je bilo tudi dokazano, da se blokada kanalčkov hERG, ki jo povzroči fenspirid, lahko pretvori v podaljšanje intervala QT pri podobni koncentraciji, kot je bila opažena v študiji hERG.
Additionally, unspecific terms of syncope, loss of consciousness, tachycardia and palpitations that may (among others) be signs and symptoms of TdP were present in a significant number of cases. 
Poleg tega so bili v znatnem številu primerov prisotni nespecifične dobe sinkope, izguba zavesti, tahikardija in palpitacije, ki so (med drugim) lahko znaki in simptomi TdP.
Fenspiride has been shown in the Aptuit study to block hERG channels at supratherapeutic doses in vitro in a heterologous expression system, with an IC50 value of 15.14 µM. 
V študiji podjetja Aptuit so dokazali, da fenspirid v supraterapevtskih odmerkih in vitro v sistemu heterolognega izražanja blokira kanalčke hERG z vrednostjo IC50, ki znaša 15,14 µM.
In addition, no effect of fenspiride was observed on the PR or QRS complex of the ECG, suggesting that fenspiride has no significant effect on other cardiac channels and no compensatory action of hERG blockade in vivo. 
Poleg tega pri kompleksu PR ali QRS EKG-ja ni bil opažen učinek fenspirida, kar kaže na to, da ta nima pomembnega učinka na druge kanalčke v srčni mišici in na blokado hERG in vivo ne deluje kompenzacijsko.
Regarding clinical data, analysis of post-marketing cases reported since the marketing authorisation showed evidence to support a causal association between occurrence of QT prolongation/TdP in patients, mostly with risk factors for these events, and the treatment with fenspiride-containing medicinal products. 
V zvezi s kliničnimi podatki so bili z analizo primerov med dejavnostjo v obdobju trženja, o katerih so poročali od podelitve dovoljenja za promet z zdravilom, podani dokazi, ki podpirajo vzročno povezavo med pojavnostjo podaljšanja intervala QT/TdP pri bolnikih, pri katerih večinoma obstajajo dejavniki tveganja za te dogodke, in zdravljenjem z zdravili, ki vsebujejo fenspirid.
In summary based on non-clinical assays of the accepted surrogate markers of TdP, i.e. blockade of hERG tail current and prolongation of the QT/QTc interval, and on post-marketing spontaneous reports of confirmed cases of TdP, QT prolongation and ventricular fibrillation/arrhythmia, the risk of QT prolongation, a proarrhythmic potential and associated risk of TdP is considered confirmed with fenspiride use. 
Na podlagi nekliničnih testov sprejetih nadomestnih markerjev TdP, tj. blokade poznega toka kanalčka hERG in podaljšanja intervala QT/QTc, ter spontanih poročil o potrjenih primerih TdP, podaljšanju intervala QT in ventrikularni fibrilaciji/aritmiji skratka velja, da proaritmični potencial in s tem povezano tveganje TdP pri uporabi fenspirida veljata za potrjena.
Taking into account that fenspiride is indicated to treat benign symptoms and the seriousness of the risk of unpredictable QT prolongation leading to proarrhythmic potential in human, the ANSM concluded that the benefit-risk balance of fenspiride-containing medicinal products was no longer favourable in the treatment of symptoms related to bronchopulmonary diseases, and suspended the marketing authorisations of these products. 
Ob upoštevanju dejstva, da je fenspirid indiciran za zdravljenje benignih simptomov, in resnosti tveganja za nepredvidljivo podaljšanje intervala QT, ki pri ljudeh povzroča proaritmični potencial, je sklenil, da razmerje med tveganji in koristmi zdravil, ki vsebujejo fenspirid, ni ugodno pri zdravljenju simptomov, povezanih z bronhopulmonarnimi boleznimi, ter je začasno umaknil dovoljenja za promet s temi zdravili.
Newly available results of two non-clinical studies showed that fenspiride can induce an inhibition of hERG tail current in vitro, and increase the corrected QT (QTc) intervals in isolated and perfused guinea pig heart. 
Rezultati dveh novih nekliničnih študij so pokazali, da fenspirid lahko sproži zaviranje poznega toka kanalčka hERG in vitro ter podaljša popravljene intervale QT (QTc) v izoliranem in perfundiranem srcu morskega prašička.
• Further, the PRAC could not identify condition(s) to the marketing authorisation which if fulfilled would demonstrate a positive benefit-risk balance for these products in a defined patient population. 
• odbor PRAC tudi ni mogel določiti pogojev za dovoljenje za promet z zdravilom, ki bi ob izpolnitvi dokazali pozitivno razmerje med tveganji in koristmi teh zdravil pri opredeljeni populaciji bolnikov,
In in silico models, fenspiride induced QT prolongation and “early afterdepolarizations” (EADs; arrhythmic makers) in specific cardiovascular disease state models. 
Na modelih in silico je fenspirid v posebnih modelih s stanjem kardiovaskularne bolezni sprožil podaljšanje intervala QT in „zgodnje naknadne depolarizacije“ (EAD; povzročiteljice aritmij).
Therefore, the PRAC concluded that the risk of QT prolongation, the proarrhythmic potential and associated risk of TdP outweighs the benefits of fenspiride in its authorised indication(s). 
Zato je odbor PRAC sklenil, da je tveganje podaljšanja intervala QT, proaritmičnega potenciala in s tem povezanega tveganja za TdP večje od koristi fenspirida pri njegovih odobrenih indikacijah.
This included the results of non-clinical studies and post-marketing case reports as well as published efficacy studies submitted by the MAHs, by stakeholders and provided by EMA. 
Med njimi so bili tudi rezultati nekliničnih študij in poročila o primerih med dejavnostmi v obdobju trženja ter študije učinkovitosti, ki so jih predložili imetniki dovoljenja za promet, zainteresirane strani in Evropska agencija za zdravila;
• The PRAC considered that the use of fenspiride is associated with a risk of QT prolongation, and therefore it has proarrhythmic potential and present a risk of Torsade de Pointes (TdP). 
• odbor PRAC je menil, da je uporaba fenspirida povezana s tveganjem podaljšanja intervala QT, zato ima proaritmični potencial in pomeni tveganje za polimorfno ventrikularno tahikardijo
The PRAC considered all data submitted by the MAHs, received from stakeholders and provided by EMA. 
Odbor PRAC je upošteval vse podatke, ki so jih predložili imetniki dovoljenja za promet z zdravilom, podatke, ki jih je prejel od zainteresiranih strani, in podatke, ki jih je predložila Evropska agencija za zdravila.
The Committee, as a consequence, considers that the benefit-risk balance of fenspiride-containing medicinal products is no longer favourable. 
odbor PRAC posledično meni, da razmerje med tveganji in koristmi zdravil, ki vsebujejo fenspirid, ni več ugodno.
The CMDh, as a consequence, considers that the benefit-risk balance of fenspiride-containing medicinal products is not favourable. 
Posledično skupina CMDh meni, da razmerje med tveganji in koristmi zdravil, ki vsebujejo fenspirid, ni ugodno.
Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the revocation of the marketing authorisations for fenspiride-containing medicinal products. 
Zato v skladu s členom 116 Direktive 2001/83/ES priporoča ukinitev dovoljenj za promet z zdravili, ki vsebujejo fenspirid.
Therefore, pursuant to Article 116 of Directive 2001/83/EC, the CMDh recommends the revocation of the marketing authorisations for fenspiride-containing medicinal products. 
Zato skupina CMDh v skladu s členom 116 Direktive 2001/83/ES priporoča ukinitev dovoljenj za promet z zdravili, ki vsebujejo fenspirid.
Consequently, the PRAC recommended the revocation of the marketing authorisations for fenspiride-containing medicinal products. 
Zato je priporočil ukinitev dovoljenj za promet z zdravili, ki vsebujejo fenspirid.
The observed prolongation may be underestimated in this study due to the necessary QT correction formula of the observed dose-dependent QTc augmentations, in view of the method used. 
Zaradi formule za popravek intervala QT, ki je potrebna pri opaženih povečanjih intervala QTc, odvisnih od odmerka, je podaljšanje, opaženo v študiji, glede na uporabljeno metodo morda podcenjeno.
In addition, performing ECG or measurements of potassium or magnesium levels is neither considered proportionate in pre-treatment screening for a medicinal product solely used to treat benign symptoms of generally self-limiting conditions, nor feasible in clinical practice. 
Poleg tega pri presejanju pred zdravljenjem z zdravilom, uporabljanim izključno za zdravljenje benignih simptomov stanj, ki so običajno samoomejujoča, izvedba EKG ali meritev ravni kalija ali magnezija ne velja za sorazmerno in tudi ne za izvedljivo v klinični praksi.
Further, the PRAC could not identify condition(s) which if fulfilled would demonstrate a positive benefitrisk balance for these products in a defined patient population. 
Odbor tudi ni mogel določiti pogojev, ki bi ob izpolnitvi pri opredeljeni populaciji bolnikov dokazali pozitivno razmerje med tveganji in koristmi teh zdravil.
The PRAC noted that this conclusion was also reached by the MAH of the originator. 
Navedel je, da je enako sklenil tudi imetnik dovoljenja za promet z zdravilom originatorja.
QT/QTc interval prolongation was not accompanied by any events of arrhythmia or contracture on the guinea pig heart model at any assay concentration. 
Na modelu srca morskega prašička pri nobeni koncentraciji testa med podaljšanjem intervala QT/QTc ni bilo dogodkov aritmije ali kontrakture.
The marketing authorisation was renewed on 20 September 2001 and on 20 September 2006. 
Dovoljenje za promet je bilo podaljšano 20. septembra 2001 in 20. septembra 2006.
The antibodies will help to protect against diseases caused by these viruses. 
Protitelesa bodo pomagala ščititi proti boleznim, ki jih povzročata ta virusa.
This means that the viruses and surface antigens are fixed onto aluminium compounds, to stimulate a better response. 
To pomeni, da so virusi in površinski antigeni vezani na aluminijeve spojine, da bi spodbudili boljši odziv.
In these cases, a fourth injection is recommended 12 months after the first dose. 
V teh primerih je priporočena tudi četrta injekcijska brizga, 12 mesecev po prvem odmerku.
It should never be injected into a vein. 
Zdravilo se ne sme nikoli injicirati v veno.
If exposed to the viruses in the future, the immune system will be able to make antibodies more quickly. 
V primeru izpostavljenosti virusu v prihodnosti bo imunski sistem sposoben hitreje tvoriti protitelesa.
The additional studies showed that the presence of antibodies was maintained for up to five years. 
Dodatne študije so pokazale, da ostanejo protitelesa v telesu prisotna do pet let.
Twinrix Adult has been studied in three main studies involving 843 healthy people aged between 18 and 60 years, most of whom were under 40 years of age. 
Zdravilo Twinrix Adult so raziskovali v treh glavnih študijah, ki so vključevale 843 zdravih ljudi, starih med 18 in 60 let, od katerih jih je bila večina mlajših od 40 let.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease. 
Cepiva delujejo tako, da imunski sistem (naravne obrambne mehanizme telesa) „učijo“, kako naj se brani proti bolezni.
It is used in adults and adolescents from 16 years of age who are not already immune to these two diseases and who are at risk of contracting both of them. 
Uporablja se pri odraslih in mladostnikih, starih 16 let in več, ki še niso imuni na ta dva virusa in pri katerih obstaja tveganje, da se okužijo z obema.
The vaccine is injected into the muscle of the upper arm. 
Cepivo se injicira v mišico nadlakti.
The three-week vaccination schedule also led to the production of antibodies in around 83% of patients, rising to around 89% after the booster dose at month 12. 
Tri tedne trajajoče cepljenje je prav tako privedlo do tvorjenja protiteles pri približno 83 % bolnikov, ta delež pa se je po poživitvenem odmerku v 12. mesecu povzpel na približno 89 %.
Further studies looked at the persistence of antibodies after vaccination in adults and adolescents, and at the schedule for vaccinating adults over three weeks when rapid protection is required. 
V drugih študijah so opazovali čas prisotnosti protiteles po cepljenju odraslih in mladostnikov in shemo cepljenja odraslih v času treh tednov, kadar je potrebna hitra zaščita.
The main measure of effectiveness was the proportion of the people who had developed antibodies against hepatitis A and B. 
Glavno merilo učinkovitosti je bil delež ljudi, pri katerih so se razvila protitelesa proti virusu hepatitisa A in B.
Each person received Twinrix Adult doses at months 0, 1 and 6. 
Vse osebe so odmerek zdravila Twinrix Adult prejele v 0., 1. in 6. mesecu.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TWINRIX ADULT EPAR summary for the public 
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) TWINRIX ADULT Povzetek EPAR za javnost
It is recommended that individuals who receive the first dose should complete all doses of Twinrix Adult. 
Priporočeno je, da posamezniki, ki prejmejo prvi odmerek, prejmejo vse odmerke zdravila Twinrix Adult.
The recommended vaccination schedule for Twinrix Adult is three doses, with a gap of one month between the first two doses and a gap of five months between the second and third. 
Priporočena shema cepljenja z zdravilom Twinrix Adult vključuje tri odmerke, dane v presledku enega meseca med prvima dvema odmerkoma in presledku petih mesecev med drugim in tretjim odmerkom.
For hepatitis B, antibodies were detected in 71% of adults after the first dose, 97% after the second dose and 99.7% after the third dose. 
Protitelesa proti hepatitisu B so opazili pri 71 % odraslih po prvem odmerku, pri 97 % po drugem odmerku in pri 99,7 % po tretjem odmerku.
The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins. 
Površinski antigeni virusa hepatitisa B se izdelujejo z metodo, ki se imenuje „tehnologija rekombinantne DNA“: proizvajajo jih kvasovke, ki so prejele gen (DNA), zaradi katerega lahko tvorijo beljakovine.
It should also not be used in people who have had an allergic reaction after being given hepatitis A or hepatitis B vaccines. 
Zdravila prav tako ne smejo uporabljati ljudje, ki so imeli po prejetju cepiva proti hepatitisu A ali hepatitisu B alergično reakcijo.
Twinrix Adult should be postponed in patients with a severe sudden fever. 
Dajanje zdravila Twinrix Adult je treba pri bolnikih s hudo nenadno vročino odložiti na pozneje.
The European Commission granted a marketing authorisation valid throughout the EU to GlaxoSmithKline Biologicals s.a. for Twinrix Adult on 20 September 1996. 
Evropska komisija je dovoljenje za promet z zdravilom Twinrix Adult, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s.a. dne 20. septembra 1996.
Twinrix Adult is a vaccine, which is available as a suspension for injection. 
Zdravilo Twinrix Adult je cepivo, ki je na voljo v obliki suspenzije za injiciranje.
Other information about Twinrix Adult: 
Druge informacije o zdravilu Twinrix Adult:
The most common side effects with Twinrix Adult (seen in more than 1 in 10 doses of the vaccine) are headache, pain and redness at the injection site, and fatigue (tiredness). 
Najpogostejši neželeni učinki, ki so povezani z zdravilom Twinrix Adult (opaženi pri več kot enem od 10 odmerkov cepiva) so glavobol, bolečina in rdečina na mestu injiciranja ter utrujenost.
The studies showed that for hepatitis A, antibodies were detected in 94% of adults after the first dose, 99.5% after the second dose and 100% after the third dose. 
Študije so pokazale, da so protitelesa proti hepatitisu A opazili pri 94 % odraslih po prvem odmerku, pri 99,5 % po drugem odmerku in pri 100 % po tretjem odmerku.
Twinrix Adult should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic). 
Zdravilo Twinrix Adult ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) katero koli od zdravilnih učinkovin, katero koli od drugih sestavin zdravila ali neomicin (antibiotik).
In exceptional cases, the three injections can be given over three weeks for adults needing rapid protection before travelling. 
V izjemnih primerih se lahko pri odraslih, ki potrebujejo hitro zaščito zaradi potovanja, tri injekcijske brizge injicirajo v obdobju treh tednov.
The Committee for Medicinal Products for Human Use (CHMP) decided that Twinrix Adult's benefits are greater than its risks for use in non-immune adults and adolescents of 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Twinrix Adult pri uporabi pri neimunih odraslih in mladostnikih, starih 16 let ali več, pri katerih obstaja tveganje okužbe s hepatitisom A in hepatitisom B, večje od z njim povezanih tveganj.
The active substances in Twinrix Adult have been available in the European Union (EU) for a number of years in separate vaccines: Havrix Adult for protection against hepatitis A and Engerix-B for protection against hepatitis B. 
Zdravilne učinkovine cepiva Twinrix Adult so v Evropski uniji (EU) na voljo že mnoga leta kot samostojna cepiva: Havrix Adult za zaščito proti virusu hepatitisa A in Engerix-B za zaščito proti virusu hepatitisa B.
Twinrix Adult is a vaccine. 
Zdravilo Twinrix Adult je cepivo.
Twinrix Adult is used to protect against hepatitis A and hepatitis B infection (diseases that affect the liver). 
Zdravilo Twinrix Adult se uporablja za zaščito pred okužbo z virusom hepatitisa A in hepatitisa B (bolezni, ki vplivata na jetra).
For the full list of all side effects reported with Twinrix Adult, see the Package Leaflet. 
Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Twinrix Adult, glejte Navodilo za uporabo.
A booster dose of Twinrix Adult, or of a separate hepatitis A or B vaccine may be given, according to official recommendations. 
Poživitveni odmerek zdravila Twinrix Adult ali ločenega cepiva proti virusu hepatitisa A ali B lahko zdravnik da skladno z uradnimi priporočili.
What benefit has Twinrix Adult shown during the studies? 
Kakšne koristi je zdravilo Twinrix Adult izkazalo med študijami?
The Committee recommended that Twinrix Adult be given marketing authorisation. 
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Twinrix Adult.
What is the risk associated with Twinrix Adult? 
Kakšna tveganja so povezana z zdravilom Twinrix Adult?
Why has Twinrix Adult been approved? 
Zakaj je bilo zdravilo Twinrix Adult odobreno?
The full EPAR for Twinrix Adult can be found here. 
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Twinrix Adult je na voljo tukaj.
Twinrix Adult contains small amounts of inactivated hepatitis A viruses and the ‘surface antigen' (proteins from the surface) of the hepatitis B virus. 
Zdravilo Twinrix Adult vsebuje majhne količine inaktiviranih virusov hepatitisa A in „površinskih antigenov“ (beljakovin iz površine) virusa hepatitisa B. Kadar oseba prejme cepivo, imunski sistem prepozna viruse in površinske antigene kot „tuje“ ter začne proti njim tvoriti protitelesa.
It contains inactivated (killed) hepatitis A viruses and parts of the hepatitis B virus as active substances. 
Zdravilo kot zdravilno učinkovino vsebuje inaktivirane (mrtve) viruse hepatitisa A in dele virusa hepatitisa B. Na voljo je v obliki 1 ml vial in 1 ml napolnjenih injekcijskih brizg.
How has Twinrix Adult been studied? 
Kako je bilo zdravilo Twinrix Adult raziskano?
What is Twinrix Adult? 
Kaj je zdravilo Twinrix Adult?
What is Twinrix Adult used for? 
Za kaj se zdravilo Twinrix Adult uporablja?
How is Twinrix Adult used? 
Kako se zdravilo Twinrix Adult uporablja?
How does Twinrix Adult work? 
Kako zdravilo Twinrix Adult deluje?
The application was submitted in the concerned member state (UK) under the mutual recognition procedure. 
Vloga je bila predložena v zadevni državi članici (Združeno kraljestvo) v skladu s postopkom medsebojnega priznavanja.
Canazole clotrimazole cream was authorised in Ireland on 8 December 2000 under Article 4.8 (a) (iii) of Directive 65/65/EEC. 
Zdravilo Canazole klotrimazol krema je bilo odobreno na Irskem dne 8. decembra 2000 v skladu s členom 4.8(a)(iii) Direktive 65/65/EGS.