natgillin/translations-raw huggingface dataset:
The non-clinical overview referred to 29 publications up to year 2010 describing pharmacodynamics, general pharmacology, pharmacokinetic and toxicology studies. 
Pregled predklinične dokumentacije se je nanašal na 29 objav do leta 2010, ki opisujejo študije farmakodinamike, splošne farmakologije, farmakokinetike in toksikologije.
Indeed, furosemide is an active substance with low solubility and low permeability (BCS class IV) which does not support an extrapolation based on pharmaceutical data. 
Dejansko je furosemid zdravilna učinkovina z nizko topnostjo in majhno prepustnostjo (razred BCS IV), kar ne podpira ekstrapolacije na podlagi farmacevtskih podatkov.
One of the factors influencing furosemide's pharmacokinetic variability is precisely the absorption process which is dependent on the intrinsic properties of this substance/low solubility, low permeability associated with unknown formulation effects. 
Eden od dejavnikov, ki vpliva na spremenljivost farmakokinetike furosemida, je prav proces absorpcije, ki je odvisen od bistvenih lastnosti te snovi / nizke topnosti, nizke prepustnosti, povezane z neznanimi učinki te oblike.
It is agreed that the manufacturing method is adequately described, however a robust manufacturing process is only a basis for further investigations on efficacy and safety of the applied product, and cannot be accepted as proof of equivalence to an authorised product. 
Odbor se strinja, da je metoda izdelave ustrezno opisana, vendar je robusten postopek izdelave zgolj osnova za nadaljnje preiskave učinkovitosti in varnosti zdravila, za katerega je vloga predložena, in ga ni mogoče upoštevati kot dokaz enakovrednosti z odobrenim zdravilom.
The lack of data regarding the bioavailibity of the product could lead to unforeseeable changes in the pharmacodynamics response and therapeutic failure, as well as the occurrence of toxic effects. 
Pomanjkanje podatkov v zvezi z biološko uporabnostjo zdravila bi lahko povzročilo nepredvidljive spremembe v farmakodinamičnem odzivu, neuspešnost zdravljenja in pojav toksičnih učinkov.
Furthermore, the group considered that there is a safety concern to put a product on the market for such indication (heart failure) when the efficacy has not been demonstrated. 
Skupina je bila tudi mnenja, da obstaja pri dajanju zdravila na trg za tovrstne indikacije (srčna odpoved) brez prikazane učinkovitosti varnostni zadržek.
In addition, for highly variables drugs, as it is the product under application, it is considered necessary to investigate the pharmacokinetics behaviour in order to exclude any other potential product-related variations. 
Poleg tega je treba za zelo spremenljiva zdravila, kot je to zdravilo, za katero je vloga predložena, raziskati farmakokinetično obnašanje, da se izključijo vsakršne druge potencialne spremembe, povezane z zdravilom.
During the decentralised procedure, Poland and Lithuania were of the opinion that bibliographic data on pharmacokinetics of furosemide, presented in the marketing authorisation dossier cannot be applied to Furosemide Vitabalans and should be regarded as not sufficient. 
V času decentraliziranega postopka sta bili Poljska in Litva mnenja, da bibliografskih podatkov o farmakokinetiki furosemida, ki so bili predstavljeni v dokumentaciji dovoljenja za promet, ni mogoče uporabiti za zdravilo Furosemide Vitabalans in jih je treba smatrati za nezadostne.
Therefore, the CHMP concluded that the efficacy of Furosemide Vitabalans has not been demonstrated in the applied indications, and this constitutes a potential serious risk to public health. 
Zato je odbor CHMP zaključil, da učinkovitost zdravila Furosemide Vitabalans v indikacijah, za katere predlagatelj vlaga vlogo, ni bila prikazana, kar predstavlja potencialno resno tveganje za javno zdravje.
The use of furosemide is wide in clinical practice and a number of published papers have been submitted in support of efficacy and safety during the decentralised procedure. 
Uporaba furosemida v klinični praksi je široka in v času decentraliziranega postopka so bili v podporo njegovi učinkovitosti ter varnosti predloženi številni objavljeni članki.
• why the pharmacokinetics parameters of the applied furosemide 40 mg product would be different than the pharmacokinetics parameters in other furosemide products described in literature and to what extent they would be expected to be different, and how this difference would cause a concrete potential serious risk to public health. 
• zakaj in v kakšnem obsegu bi bili farmakokinetični parametri zdravila furosemid 40 mg, za katerega je vloga predložena, drugačni od farmakokinetičnih parametrov drugih izdelkov s furosemidom, opisanih v literaturi, in kako bi ta razlika povzročila konkretno potencialno resno tveganje za javno zdravje.
• how the applied furosemide 40 mg product would cause a potential serious risk to public health 
• kako bi zdravilo furosemid 40 mg, za katerega je vloga predložena, povzročilo potencialno resno tveganje za javno zdravje;
• why the safety and efficacy of the applied furosemide 40 mg product would be effectively different than in other furosemide 40 mg products 
• zakaj bi bili varnost in učinkovitost zdravila furosemid 40 mg, za katerega je vloga predložena, učinkovito drugačni od drugih zdravil s 40 mg furosemida;
Part II.1.d) of Annex I of Directive 2001/83/EC states that “the non-clinical and/or clinical overviews must explain the relevance of any data submitted which concern a product different from the product intended for marketing. 
Del II.1.d) Priloge I Direktive 2001/83/ES navaja, da „morajo pregledi predklinične in/ali klinične dokumentacije pojasniti pomen vsakršnih predloženih podatkov, ki zadevajo drugačno zdravilo od zdravila, namenjenega za trženje.
The CHMP is of the opinion that the comparability of the bioavailability between the applied product and a product included in the submitted literature should have been shown in order to claim the same indication. 
Odbor CHMP meni, da bi bilo treba prikazati primerljivost biološke uporabnosti med zdravilom, za katerega je vloga predložena, in zdravilom, vključenim v predloženo literaturo, da bi lahko sklepali na enake indikacije.
The CHMP has recommended the refusal of the granting of the marketing authorisation for Furosemide Vitabalans and associated names (see Annex I). 
Odbor CHMP je priporočil zavrnitev izdaje dovoljenja za promet z zdravilom Furosemide Vitabalans in povezanimi imeni (glejte Prilogo I).
A judgement must be made whether the product studied can be considered as similar to the product for which application for marketing authorisation has been made in spite of existing differences”. 
Presoditi je treba, ali je preučevano zdravilo mogoče obravnavati kot podobno zdravilu, za katerega je bila podana vloga za pridobitev dovoljenja za promet kljub obstoječim razlikam“.
It was considered necessary to have in vivo data especially with a drug exhibiting such wide range of pharmacokinetic values. 
Podatki in vivo so zlasti potrebni pri zdravilu, ki kaže tako širok razpon farmakokinetičnih vrednosti.
• Pharmaceutical data 
• farmacevtske podatke
• Clinical data 
• klinične podatke
Therefore, it not possible to conclude that the efficacy and safety of Furosemide Vitabalans will be the same as that of the products containing furosemide included in the submitted literature. 
Zato ni mogoče zaključiti, da bo učinkovitost in varnost zdravila Furosemide Vitabalans enaka kot pri drugih zdravilih s furosemidom, ki so vključena v predloženo literaturo.
Furthermore, in vitro data cannot be sole proof that the clinical data from the submitted studies are applicable to Furosemide Vitabalans. 
Poleg tega podatki in vitro ne morejo biti edini dokaz, da klinični podatki iz predloženih študij veljajo za zdravilo Furosemide Vitabalans.
Furthermore, the applicant provided a set of dissolution profiles comparing Furosemide Vitabalans with nine other furosemide 40 mg tablets. 
Poleg tega je predlagatelj predložil niz profilov raztapljanja, ki primerjajo zdravilo Furosemide Vitabalans z devetimi drugimi tabletami s 40 mg furosemida.
In order to show the relevance of the bibliographic data used in support of the application for Furosemide Vitabalans, the applicant made reference to: 
Z namenom prikaza pomena bibliografskih podatkov, ki so bili uporabljeni za podporo vlogi za pridobitev dovoljenja za promet z zdravilom Furosemide Vitabalans, je predlagatelj navedel:
Diuretic efficacy of high dose furosemide pharmacokinetics and pharmacodynamics in health and diseasean update. 
Diuretic efficacy of high dose furosemide pharmacokinetics and pharmacodynamics in health and disease - an update (Diuretska učinkovitost farmakokinetike in farmakodinamike furosemida v velikih odmerkih na zdravje in bolezni - posodobitev).
• Pharmacokinetics data 
• farmakokinetične podatke
Furthermore, given that furosemide is a highly variable compound, the submission of in vivo data was considered necessary in order to characterise the PK of the product together with justification that would allow establishing a bridge to the published data. 
Ker je furosemid zelo spremenljiva sestavina, se je predložitev podatkov in vivo smatrala za potrebno zaradi karakterizacije farmakokinetike zdravila skupaj z utemeljitvijo, ki bi omogočila povezavo z objavljenimi podatki.
As mentioned previously, Annex I of Directive 2001/83/EC states that the non-clinical and/or clinical overviews must explain the relevance of any data submitted which concern a product different from the product intended for marketing. 
Kot je navedeno zgoraj, Priloga I Direktive 2001/83/ES navaja, da morajo pregledi predklinične in/ali klinične dokumentacije pojasniti pomen vsakršnih predloženih podatkov, ki zadevajo drugačno zdravilo od zdravila, namenjenega za trženje.
The CHMP considered that a wide range of pharmacokinetic values for different furosemide 40 mg products did not prove that the pharmacokinetic parameters of Furosemide Vitabalans will be within the same range. 
Odbor CHMP je presodil, da širok razpon farmakokinetičnih vrednosti za različna zdravila s 40 mg furosemida dokazuje, da bodo farmakokinetični parametri zdravila Furosemide Vitabalans znotraj istega razpona.
The study in support of the safety of furosemide (Dormans et al.1) presented by the applicant, was not considered as relevant by the CHMP, as furosemide in this study was used intravenously and Furosemide Vitabalans is intended to be used in oral administration as a 40mg tablet. 
Študije v podporo varnosti furosemida (Dormans in sod.1), ki jo je predložil predlagatelj, odbor CHMP ni upošteval za ustrezno, saj je bil v tej študiji furosemid uporabljan intravensko, zdravilo Furosemide Viatabalans pa je namenjeno za peroralno uporabo v obliki 40 mg tablet.
In response to the CHMP, the applicant further referred to published pharmacokinetics data presenting PK parameters of similar tablets formulations to Furosemide Vitabalans as well as different formulations (e.g. tablet 20mg). 
Kot odgovor odboru CHMP je predlagatelj nadalje navedel objavljene farmakokinetične podatke, ki predstavljajo farmakokinetične parametre tablet, podobnih zdravilu Furosemide Vitabalans, kot tudi drugačnih formulacij (npr. 20-miligramske tablete).
The pharmacokinetic parameters available in the literature are not sufficient to claim that Furosemide Vitabalans would have a similar bioavailability. 
Farmakokinetični parametri, ki so na voljo v literaturi, niso zadostni za potrditev, da ima zdravilo Furosemide Vitabalans podobno biološko uporabnost.
The group considered that manufacturing methods or dissolution data could not predict how the product would behave in vivo. 
Skupina je bila prav tako mnenja, da z metodami izdelave ali s podatki o raztapljanju ni mogoče predvideti obnašanja zdravila in vivo.
The CHMP is of the opinion that the applicant has not adequately demonstrated that the submitted published literature on furosemide was directly applicable to Furosemide Vitabalans. 
Odbor CHMP meni, da predlagatelj ni ustrezno predstavil, da je mogoče predloženo objavljeno literaturo o furosemidu neposredno uporabiti za zdravilo Furosemide Vitabalans.
A judgement must be made whether the product studied can be considered as similar to the products, for which application for a marketing authorisation has been made in spite of the existing differences. 
Presoditi je treba, ali je preučevano zdravilo mogoče obravnavati kot podobno zdravilu, za katerega je bila predložena vloga za pridobitev dovoljenja za promet kljub obstoječim razlikam.
As discussed previously, in vitro data demonstrating similarity of dissolution profiles between Furosemide Vitabalans and other products containing furosemide do not prove that the bioavailability of these products would be similar, in particular, with a BCS class IV drug substance (low solubility, low permeability). 
Kot je bilo predhodno obravnavano, podatki in vitro za prikaz podobnosti profilov raztapljanja med zdravilom Furosemide Vitabalans z drugimi zdravili s furosemidom ne dokazujejo podobnosti biološke uporabnosti, zlasti z biofarmacevtskim zdravilom razreda IV (nizka topnost, nizka prepustnost).
The applicant also argued that dissolution behaviour together with evident pharmaceutical equivalence proves bridging between Furosemide Vitabalans and other authorised furosemide 40mg products. 
Predlagatelj je prav tako trdil, da obnašanje pri raztapljanju skupaj z evidentno farmacevtsko enakovrednostjo dokazuje povezavo med zdravilom Furosemide Vitabalans z drugimi zdravili s 40 mg furosemida.
An ad-hoc expert meeting was convened on 13 February 2013 at the request of the applicant. 
Na zahtevo predlagatelja je bila 13. februarja sklicana adhoc seja strokovnjakov.
The applicant's argument that traditional manufacturing methods as well as excipients widely used in tablet formulations would not cause potential lower or higher exposure to furosemide when Furosemide Vitabalans is used (compared to the exposure obtained following administration of other furosemide 40 mg tablets) cannot be considered as sufficient evidence to bridge the applied product and other furosemide described in the literature. 
Predlagateljevega argumenta, da tradicionalne metode izdelave in pomožne snovi, ki jih široko uporabljajo v tabletah, ne povzročajo potencialno manjše ali večje izpostavljenosti furosemidu ob uporabi zdravila Furosemide Vitabalans (v primerjavi z izpostavljenostjo, ugotovljeno po dajanju drugih tablet s 40 mg furosemida), ni mogoče upoštevati kot zadostnega dokaza za povezavo zdravila, za katerega je vloga predložena, z drugimi oblikami furosemida, opisanimi v literaturi.
Indeed, it cannot be excluded that the formulation of the applied product would behave differently in terms of pharmacokinetics compared to the products containing furosemide included in the submitted literature. 
Ni mogoče izključiti, da bi se oblika zdravila, za katerega je vloga predložena, v smislu farmakokinetike obnašala drugače kot zdravila s furosemidom, vključena v predloženo literaturo.
The ad-hoc expert group considered that the published literature and the dissolution data provided by the applicant were not sufficient to prove the safety and efficacy of Furosemide Vitabalans. 
Ad-hoc skupina strokovnjakov je bila mnenja, da objavljena literatura in podatki o raztapljanju, ki jih je predložil predlagatelj, niso zadostni za dokaz varnosti in učinkovitosti zdravila Furosemide Vitabalans.
Additional data would be needed to support the relevance of the bibliographic data to demonstrate the safety and efficacy of Furosemide Vitabalans. 
Potrebni bi bili dodatni podatki, da bi lahko predstavili pomen bibliografskih podatkov za prikaz varnosti in učinkovitosti zdravila Furosemide Vitabalans.
The dossier submitted by the applicant did not include any in vivo clinical data which could have demonstrated that pharmacokinetic profile of Furosemide Vitabalans is similar to the products containing furosemide included in the submitted literature. 
Dokumentacija, ki jo je predložil predlagatelj, ni vključevala kliničnih podatkov in vivo, ki bi lahko prikazali podobnost farmakokinetičnega profila zdravila Furosemide Vitabalans z zdravili s furosemidom, vključenimi v predloženo literaturo.
Based only on published literature data, it is not possible to conclude that the pharmacokinetic parameters of Furosemide Vitabalans would be within the same range than other furosemide 40 mg tablets referred to. 
Na osnovi podatkov iz objavljene literature ni mogoče sklepati, da bi bili farmakokinetični parametri zdravila Furosemide Vitabalans znotraj enakega območja kot druge omenjene tablete s 40 mg furosemida.
To support the efficacy and safety of Furosemide Vitabalans, the applicant only referred to published studies. 
V podporo učinkovitosti in varnosti zdravila Furosemide Vitabalans je predlagatelj navedel le objavljene študije.
Therefore, the literature data submitted by the applicant to support the safety and efficacy of furosemide did not provide sufficient evidence that the pharmacokinetics of Furosemide Vitabalans allow its safe and effective use in the same dosage and indications applied for. 
Zato podatki iz literature, ki jih je predložil predlagatelj v podporo varnosti in učinkovitosti furosemida, niso zagotovili zadostnih dokazov, da farmakokinetika zdravila Furosemide Vitabalans omogoča varno in učinkovito uporabo tega zdravila v odmerkih in indikacijah, za katere predlagatelj vlaga vlogo.
The applicant's argument that traditional manufacturing methods as well as excipients widely used are sufficient to demonstrate the bridging between Furosemide Vitabalans and other furosemide products cannot be accepted. 
Predlagateljevega argumenta, da tradicionalne metode izdelave in pomožne snovi, ki jih široko uporabljajo, zadostujejo za povezavo zdravila Furosemide Vitabalans z drugimi izdelki s furosemidom, ni mogoče sprejeti.
The results of this study showing that Furosemide Vitabalans had a similar dissolution profile as the other furosemide presented were not considered sufficient by the CHMP to demonstrate efficacy and safety of the product applied for. 
Rezultatov te študije, ki dokazuje, da je imelo zdravilo Furosemide Vitabalans podoben profil raztapljanja kot druge predstavljene oblike furosemida, odbor CHMP ni upošteval kot zadostnih za prikaz učinkovitosti in varnosti zdravila, za katerega predlagatelj predlaga vlogo za dovoljenje za promet z zdravilom.
A referral was thus triggered at the CMD(h) and the applicant was asked to justify that the literature provided in support of this application was applicable to the product applied for and to demonstrate that the potentially lower or higher exposure to furosemide, when Furosemide Vitabalans is used compared to the exposure obtained following administration of the product used in the pivotal clinical studies described in the submitted literature, would not influence efficacy or safety. 
Zato je bil sprožen napotitveni postopek pri Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopekzdravila za uporabo v humani medicini CMD(h), predlagatelj pa je bil pozvan k utemeljitvi, da literatura, ki jo je predložil v podporo tej vlogi, velja za zdravilo, za katerega je vloga predložena, in dokaže, da potencialno manjša ali večja izpostavljenost furosemidu ne vpliva na učinkovitost in varnost uporabe zdravila Furosemide Vitabalans v primerjavi z izpostavljenostjo, ugotovljeno po dajanju uporabljenega zdravila v ključnih kliničnih študijah, opisanih v predloženi literaturi.
On the basis of the bibliographic data submitted, taken together with additional pharmaceutical documentation, the applicant failed to establish the relevance of these data to demonstrate the safety and efficacy of Furosemide Vitabalans and associated names. 
Na podlagi predloženih bibliografskih podatkov skupaj z dodatno farmacevtsko dokumentacijo predlagatelj ni uspešno predstavil pomena teh podatkov za prikaz varnosti in učinkovitosti zdravila Furosemide Vitabalans in povezanih imen.
The major concern raised by Poland and Lithuania could not be solved during the CMD(h) referral and the issue was therefore referred to the CHMP. 
Ker glavnega zadržka, ki sta ga izpostavili Poljska in Litva, ni bilo mogoče razrešiti v času napotitvenega postopka pri Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini, je bila zadeva napotena na odbor CHMP.
The applicant's arguments saying that there is no correlation between the absorbed amount of furosemide and the diuresis, and that controlled-released and immediate-released formulation produce almost as much diuresis, was not considered as sufficient to prove the efficacy of Furosemide Vitabalans. 
Predlagateljevi argumenti, v katerih je navedel, da ni povezave med absorbirano količino furosemida in diurezo ter da imata oblika s kontroliranim sproščanjem in oblika s takojšnjim sproščanjem skoraj enako diurezo, niso bili upoštevani kot zadostni za dokaz učinkovitosti zdravila Furosemide Vitabalans.
The applicant's arguments that there is no correlation between the absorbed amount of furosemide and the diuresis, and that controlled-released and immediate-released formulation produce almost as much diuresis, were not considered as sufficient by the group to prove the safety and efficacy of Furosemide Vitabalans. 
Predlagateljevih argumentov, da ni povezave med absorbirano količino furosemida in diurezo ter da imata oblika s kontroliranim sproščanjem in oblika s takojšnjim sproščanjem skoraj enako diurezo, skupina ni upoštevala kot zadostnih za dokaz o varnosti in učinkovitosti zdravila Furosemide Vitabalans.
On the basis of the bibliographic data submitted, taken together with the pharmaceutical data, the applicant failed to establish the relevance of these data to demonstrate safety and efficacy of Furosemide Vitabalans. 
Na podlagi predloženih bibliografskih podatkov skupaj s farmacevtskimi podatki predlagatelj ni uspešno predstavil pomena teh podatkov za prikaz varnosti in učinkovitosti zdravila Furosemide Vitabalans.
• The provided data do not show that Furosemide Vitabalans is similar to the products described in the submitted literature. 
• predloženi podatki ne kažejo na to, da je zdravilo Furosemide Vitabalans podobno zdravilom,
A scientifically valid approach such as the demonstration of comparable pharmacokinetics was considered necessary to bridge Furosemide Vitabalans to a similar product. 
Za povezavo zdravila Furosemide Vitabalans s podobnimi zdravili je potreben znanstveno veljaven pristop, kot na primer predstavitev primerljive farmakokinetike.
• The Committee considered the notification of the referral triggered by Estonia under Article 29(4) 
• je Odbor upošteval obvestilo o napotitvenem postopku, ki ga je sprožila Estonija skladno s členom 29(4) Direktive 2001/83/ES ter sta Poljska in Litva presodili, da izdaja dovoljenja za promet predstavlja potencialno resno tveganje za javno zdravje;
360 ELISA Units 
360 ELISA enot
Hepatitis B surface antigen3,4 
Površinski antigen virusa hepatitisa B
EMA procedure number 
Številka EU
1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated 
Pridobljen na humanih diploidnih celicah (MRC-5) 2Adsorbiran na hidratirani aluminijev hidroksid
Content (concentration) 
Pot uporabe Stična Ovojnina Vsebina (koncentracija)
3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate 
Pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae) Adsorbiran na aluminijev fosfat
1 dose (0.5 ml): Hepatitis A virus (inactivated)1,2 
Virus hepatitisa A (inaktivirani)
1 pre-filled syringe without needle 
1 napolnjena injekcijska brizga brez igle
This means it has a long duration of action. 
To pomeni, da je njegovo delovanje dolgotrajno.
The study in children lasted 16 weeks. 
Študije pri otrocih so trajale 16 tednov.
All the studies in adults lasted six months, but one was extended to one year. 
Vse študije pri odraslih so trajale šest mesecev, eno od njih pa so podaljšali na eno leto.