natgillin/translations-raw huggingface dataset:
People vaccinated with Ervebo should continue to take precautions to protect themselves from Ebola virus disease. 
Osebe, ki so bile cepljene s cepivom Ervebo, bi morale še naprej izvajati previdnostne ukrepe, da se zaščitijo pred ebolo.
Ervebo contains a virus known as vesicular stomatitis virus which has been weakened and modified to contain a protein from the Zaire Ebola virus. 
Zdravilo Ervebo vsebuje virus vezikularnega stomatitisa, ki je bil oslabljen in spremenjen tako, da vsebuje beljakovino iz virusa Ebola Zaire.
Ervebo should be used in individuals at risk of infection with Ebola virus. 
Zdravilo Ervebo je treba dajati osebam, pri katerih obstaja nevarnost okužbe z virusom ebole.
How is Ervebo used? 
Kako se zdravilo Ervebo uporablja?
How does Ervebo work? 
Kako deluje zdravilo Ervebo?
For the full list of side effects and restrictions of Ervebo, see the package leaflet. 
Celotni seznam neželenih učinkov in omejitev pri uporabi zdravila Ervebo je na voljo v navodilu za uporabo.
The active substance in Ervebo contains a protein found on the Ebola Zaire virus. 
Učinkovina v zdravilu Ervebo vsebuje beljakovino virusa Ebola Zaire.
This helps to protect against the disease. 
To pomaga pri zaščiti pred boleznijo.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary. 
Evropska agencija za zdravila (EMEA) bo vsako leto pregledala nove informacije, ki bodo morda postale razpoložljive, in po potrebi posodobila ta povzetek.
These usually disappear within one to two days without treatment. 
Ti neželeni učinki običajno minejo brez zdravljenja v 1-2 dneh.
It contains a flu strain called A/Viet Nam/1194/2004 (H5N1). 
Vsebuje sev gripe, imenovan A/Viet Nam/1194/2004 (H5N1).
They will then collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation. 
Tedaj bodo zbrali informacije o varnosti in učinkovitosti končnega pandemičnega cepiva in jih posredovali v oceno CHMP.
The vaccine also contains an ‘adjuvant' (a compound containing aluminium) to stimulate a better response. 
Cepivo vsebuje tudi „adjuvans“ (spojino, ki vsebuje aluminij) za stimulacijo boljšega odziva.
This will include information on its side effects and its safety in children, pregnant women, patients with severe conditions, and people who have problems with their immune systems. 
Te informacije bodo vključevale podatke o njegovih neželenih učinkih ter njegovi varnosti pri otrocih, nosečnicah, resno bolnih bolnikih in ljudeh, ki imajo težave z imunskim sistemom.
It is given by injection into the upper arm muscle. 
Daje se z injekcijo v mišico nadlakti.
This is a special type of vaccine that can be developed to help with the management of a pandemic. 
To je posebna vrsta cepiva, ki ga je mogoče razviti za pomoč pri nadzorovanju pandemije.
The virus is whole, but it has been inactivated (killed) so that it does not cause disease. 
Virus je cel, vendar inaktiviran (ubit), tako da ne povzroča bolezni.
The European Commission granted a marketing authorisation valid throughout the EU for Daronrix to GlaxoSmithKline Biologicals s.a. on 21 March 2007. 
Evropska komisija je dovoljenje za promet z zdravilom Daronrix, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s.a. dne 21. marca 2007.
The main measures of effectiveness were the levels of antibodies against the flu virus in the patients' blood before vaccination, on the day of the second injection (day 21), and 21 days later (day 42). 
Glavna merila učinkovitosti so bile koncentracije protiteles proti virusu gripe v krvi bolnika pred cepljenjem, na dan drugega cepljenja (21. dan) in 21 dni kasneje (na 42. dan).
This means that because the strain of flu virus that may cause a pandemic is not known, it has not been possible to obtain full information about the future pandemic vaccine. 
To pomeni, da zaradi tega, ker sev virusa, ki utegne povzročiti pandemijo, ni znan, ni bilo mogoče pridobiti celovitih informacij o cepivu za bodočo pandemijo.
They can test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing a pandemic is included. 
To cepivo lahko preizkusijo, da bi preverili, kako se ljudje nanj odzivajo, na podlagi česar lahko predvidevajo, kako se bodo ljudje odzivali, ko se bo pojavil sev gripe, ki povzroča pandemijo.
21 days after the second injection, 70.8% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1. 
Enaindvajset dni po drugem injiciranju je imelo 70,8 % ljudi, ki so prejeli cepivo, koncentracijo protiteles, ki bi jih lahko zaščitila proti H5N1.
Daronrix contains small amounts of a virus called H5N1. 
Zdravilo Daronrix vsebuje majhne količine virusa, imenovanega H5N1.
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 (naravno obrambo telesa) »naučijo«, kako naj se brani pred boleznijo.
The effects of Daronrix were first tested in experimental models before being studied in humans. 
Učinki zdravila Daronrix so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
This summary was last updated in 03-2007.©EMEA 2007 
Ta povzetek je bil nazadnje posodobljen 03-2007.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) DARONRIX EPAR summary for the public 
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) DARONRIX Povzetek EPAR za javnost
Daronrix is given in two doses, at least three weeks apart. 
Zdravilo Daronrix se daje v dveh odmerkih v razmaku najmanj treh tednov.
Daronrix has been authorised under “Exceptional Circumstances”. 
Zdravilo Daronrix je bilo odobreno v »izjemnih okoliščinah«.
Daronrix is a vaccine that can only be used once a flu ‘pandemic' has been officially declared by the World Health Organization (WHO) or European Union (EU). 
Zdravilo Daronix je cepivo, ki se lahko uporablja šele potem, ko Svetovna zdravstvena organizacija (WHO) ali Evropska unija (EU) uradno razglasi pandemijo gripe.
According to criteria laid down by the Committee for Medicinal Products for Human Use (CHMP), a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable. 
V skladu z merili, ki jih je določil Odbor za zdravila za uporabo v humani medicini (CHMP), morajo modelna cepiva, da lahko veljajo kot primerna, zagotoviti zaščitno koncentracijo protiteles pri vsaj 70 % ljudi.
Before a pandemic starts, nobody knows which strain of flu virus will be involved, so companies cannot prepare the correct vaccine in advance. 
Pred začetkom pandemije ni znano, kateri sev virusa gripe bo razsajal, zato podjetja ne morejo vnaprej pripraviti pravega cepiva.
It is a suspension for injection that contains influenza (flu) viruses that have been inactivated (killed). 
Je suspenzija za injiciranje, ki vsebuje inaktivirane (ubite) viruse gripe.
Daronrix should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any substances found at trace levels in the vaccine, such as eggs, chicken protein or gentamicin sulphate (an antibiotic). 
Zdravila Daronrix se ne sme dajati bolnikom, ki so imeli v preteklosti anafilaktično reakcijo (hudo alergijsko reakcijo) na katero koli izmed sestavin cepiva ali na katero koli od snovi, ki se v sledeh nahajajo v cepivu, kot npr. na jajca, piščančje beljakovine ali gentamicinijev sulfat (antibiotik).
If a pandemic has started, however, it may be appropriate to give the vaccine to these patients, as long as facilities for resuscitation are available. 
Vendar pa bo v pandemičnih razmerah cepljenje takih bolnikov morda vseeno upravičeno, če bo na voljo oprema za oživljanje.
Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune. 
Lahko pa pripravijo cepivo, ki vsebuje posebej izbran sev virusa gripe, ki mu ni bil še nihče izpostavljen in na katerega ni nihče imun.
Other information about Daronrix: 
Druge informacije o zdravilu Daronrix:
Daronrix would be given according to official recommendations. 
Zdravilo Daronrix se daje v skladu z uradnimi priporočili.
Which measures are being taken to ensure the safe use of Daronrix? 
Kateri ukrepi se izvajajo za zagotavljanje varne uporabe zdravila Daronrix?
When a person is given the vaccine, the immune system recognises the inactivated virus as ‘foreign' and makes antibodies against it. 
Ko oseba prejme cepivo, imunski sistem prepozna inaktiviran virus kot tujek in proti njemu razvije protitelesa.
The committee recommended that Daronrix be given marketing authorisation. 
Odbor je zato priporočil, da se za zdravilo Daronrix podeli dovoljenje za promet.
The study showed that Daronrix containing 15 micrograms of haemagglutinin and the adjuvant produced an antibody response that satisfies these criteria. 
Raziskava je pokazala, da zdravilo Daronrix, vsebujoče 15 mikrogramov hemaglutinina in adjuvans, izzove odziv protiteles, ki zadovolji to merilo.
If Daronrix is used during a pandemic, the company that makes it will collect information on the safety of the vaccine while it is being used. 
Če se bo zdravilo Daronrix uporabljalo med pandemijo, bo podjetje, ki ga izdeluje, zbralo informacije o varnosti cepiva med njegovo uporabo.
The CHMP concluded that Daronrix's benefits outweighed its risks, and that it had shown its suitability as a mock-up vaccine in preparation for a pandemic flu outbreak. 
CHMP je zaključil, da prednosti zdravila Daronrix presegajo z njim povezana tveganja ter da se je zdravilo izkazalo kot ustrezno za modelno cepivo za primer izbruha pandemične gripe.
The most common side effects with Daronrix (seen in more than 1 in 10 people) are headache, pain and redness at the site of the injection, and fatigue (tiredness). 
Najpogostejši neželeni učinki zdravila Daronrix (opaženi pri več kot 1 bolniku izmed 10) so glavobol, bolečina in rdečina na mestu injiciranja ter utrujenost.
The participants received two injections of Daronrix, containing one of four different amounts of haemagglutinin (a protein found in flu viruses), with or without the adjuvant, 21 days apart. 
Udeleženci so prejeli dve injekciji zdravila Daronrix, ki sta vsebovali eno od štirih različnih količin hemaglutinina (beljakovine, ki se nahaja v virusih gripe) z adjuvansom ali brez njega v razmaku 21 dni.
A flu pandemic occurs when a new type (strain) of flu virus emerges that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world. 
Pandemija gripe nastopi, ko se pojavi nova vrsta (sev) virusa gripe, ki se lahko enostavno širi od človeka do človeka, ker ljudje nanj niso imuni (zaščiteni proti njemu).
Daronrix is a vaccine. 
Zdravilo Daronrix je cepivo.
If a pandemic starts, the virus strain in Daronrix will be replaced by the strain causing the pandemic before the vaccine can be used. 
V primeru izbruha pandemije bo sev virusa v zdravilu Daronrix nadomeščen s sevom, ki povzroča pandemijo, preden bo cepivo mogoče uporabljati.
What benefit has Daronrix shown during the studies? 
Kakšne koristi je zdravilo Daronrix izkazalo med raziskavami?
If a pandemic is declared, and if the company that makes Daronrix decides to market the vaccine, they will include the flu strain responsible in the vaccine. 
V primeru razglasitve pandemije in če se bo podjetje, ki izdeluje zdravilo Daronrix, odločilo za njegovo trženje, bodo v cepivo vključili pandemični sev virusa gripe.
The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again. 
V tem primeru lahko imunski sistem, če je ponovno izpostavljen virusu, hitreje tvori protitelesa.
For the full list of all side effects reported with Daronrix, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Daronrix, glejte Navodilo za uporabo.
Why has Daronrix been approved? 
Zakaj je bilo zdravilo Daronrix odobreno?
Daronrix is a ‘mock-up' vaccine. 
Zdravilo Daronrix je »modelno« cepivo.
What information is still awaited for Daronrix? 
Katere informacije o zdravilu Daronrix še pričakujemo?
What is the risk associated with Daronrix? 
Kakšna tveganja so povezana z zdravilom Daronrix?
The full EPAR for Daronrix can be found here. 
Celotno javno poročilo o oceni zdravila (EPAR) za zdravilo Daronrix je na voljo tukaj.
What is Daronrix? 
Kaj je zdravilo Daronrix?
How has Daronrix been studied? 
Kako je bilo zdravilo Daronrix raziskano?
How does Daronrix work? 
Kako zdravilo Daronrix deluje?
The main study of Daronrix included 387 healthy adults and compared the ability of different doses of Daronrix, with or without the adjuvant, to trigger the production of antibodies (immunogenicity). 
V njej so preučevali učinkovitost različnih odmerkov zdravila Daronrix z adjuvansom ali brez njega pri sprožanju nastajanja protiteles (imunogenosti).
How is Daronrix used? 
Kako se zdravilo Daronrix uporablja?
What is Daronrix used for? 
Za kaj se zdravilo Daronix uporablja?
Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States 
Pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, ki jih morajo uvesti države članice
NovoSeven has been approved in the European Union since 1996. 
NovoSeven je v Evropski uniji odobren od leta 1996.
The Company submitted the results of three studies, involving a total of 486 patients. 
Podjetje je predložilo rezultate treh raziskav, v katerih je sodelovalo skupaj 486 bolnikov.
The letter from the Company notifying the EMEA of the withdrawal of the application is available here. 
Dopis, s katerim je podjetje obvestilo EMEA o umiku vloge, je na voljo tukaj.
QUESTIONS AND ANSWERS ON WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for NOVOSEVEN 
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA SPREMEMBO DOVOLJENJA ZA PROMET z zdravilom NOVOSEVEN
What is NovoSeven? 
Kaj je zdravilo NovoSeven?
Following CHMP opinion, it usually takes around 6 weeks to the European Commission to update the licence. 
Ko CHMP poda mnenje, Evropska komisija v približno 6 tednih posodobi dovoljenje.
International Non-proprietary Name (INN): eptacog alfa (activated) 
Mednarodno nelastniško ime (INN): eptakog alfa (aktiviran)
The data submitted show that NovoSeven has an effect on the volume of the haemorrhage, but it is not clear how this effect translates into a better outcome for the patient, especially at the dose selected for this indication. 
Predloženi podatki kažejo, da zdravilo NovoSeven vpliva na volumen krvavitve, vendar ni jasno, kako je ta učinek povezan z boljšim izidom za bolnika, zlasti pri odmerku, izbranem za to indikacijo.
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with NovSeven? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih / programih sočutne uporabe zdravila NovoSeven?
In addition, there were concerns on the thromboembolic side effects (excessive clotting) for this indication, but the number of patients treated was too small for the CHMP to be able to balance this risk against the potential benefit. 
Poleg tega obstajajo zadržki v zvezi s tromboemboličnimi stranskimi učinki (prekomerno strjevanje) za to indikacijo, vendar je bilo število zdravljenih bolnikov premajhno, da bi CHMP lahko ovrednotil to tveganje glede na morebitne koristi.
The main study was carried out in 399 patients (aged 66 on average), and compared the effectiveness of three dosages of NovoSeven to that of a placebo (dummy treatment). 
V glavno raziskavo je bilo vključenih 399 bolnikov (povprečne starosti 66 let), v njej pa so primerjali učinkovitost treh odmerkov zdravila NovoSeven s placebom (zdravilom brez zdravilne učinkovine).
On 3 April 2006, Novo Nordisk A/S has officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a new indication for NovoSeven, in the treatment of acute intracerebral haemorrhage (ICH) in adults for limiting haemorrhage growth and improving clinical outcome. 
Podjetje Novo Nordisk A/S je 3.aprila 2006 uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za novo indikacijo za zdravilo NovoSeven, in sicer zdravljenje akutne znotrajmožganske krvavitve (ZMK) pri odraslih za omejitev krvavitve in za izboljšanje kliničnega izida.
The application was at Day 157 when the Company withdrew it. 
Ko je podjetje vlogo umaknilo, je bila le-ta v postopku 157. dan.
There are no consequences for NovoSeven's use in the indications for which it is already authorised, where the known benefit and risk remain unchanged. 
Omenjeno nima posledic za uporabo zdravila NovoSeven za indikacije, za katere je bilo zdravilo že odobreno, in pri katerih ostaja razmerje med koristmi in tveganji nespremenjeno.
Therefore, at the time of the withdrawal, the CHMP's view was that the benefit had not been sufficiently demonstrated and did not outweigh the identified risks. 
Posledično je CHMP v času umika menil, da koristi niso bile dokazane v zadostni meri in niso večje od znanih tveganj.
It increases the production of thrombin, another coagulation factor, on the surface of the particles that make up blood clots (the platelets), and this helps producing a stable ‘plug' at the site of bleeding. 
Poveča proizvodnjo trombina, še enega koagulacijskega faktorja, na površini delcev, ki tvorijo krvne strdke (trombocitov), kar pripomore k nastanku stabilnega “zamaška” na mestu krvavitve.
What documentation has been presented by the Company to support the application to the CHMP? 
Katero dokumentacijo je podjetje predložilo CHMP v podporo svoji vlogi?
It is also used in patients with acquired haemophilia, in patients with congenital factor VII deficiency, and in patients with Glanzmann's thrombasthenia (a rare bleeding disorder) who cannot be treated by a transfusion of platelets. 
Uporablja se tudi pri bolnikih s pridobljeno hemofilijo, pri bolnikih s prirojenim pomanjkanjem faktorja VII in pri bolnikih z Glanzmannovo trombastenijo (redko motnjo strjevanja krvi), ki jih ni mogoče zdraviti s transfuzijo trombocitov.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that NovoSeven could not be approved for the treatment of acute intracerebral haemorrhage. 
Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj, ki jih je zastavil CHMP, je imel Odbor v času umika vloge zadržke in bil začasnega mnenja, da zdravila NovoSeven ni mogoče odobriti za zdravljenje akutne znotrajmožganske krvavitve.
The main concern of the CHMP was that the data were too limited to evaluate the benefit and the potential risks of NovoSeven in intracerebral haemorrhage. 
Glavni zadržek CHMP je bil, da je podatkov premalo, da bi lahko ovrednotili koristi in morebitna tveganja zdravila NovoSeven pri znotrajmožganski krvavitvi.
The effectiveness of NovoSeven was assessed by looking at its effect on the volume of the haemorrhage inside the brain, measured using a scan (percentage change in the volume after 24 hours of treatment with NovoSeven or placebo). 
Učinkovitost zdravila NovoSeven je bila ocenjena glede na to, kakšen je njegov učinek na volumen krvavitve znotraj možganov, izmerjeno s slikanjem (sprememba volumna v odstotkih po 24 urah zdravljenja z zdravilom NovoSeven ali placebom).
NovoSeven was to be used to treat adult patients with intracerebral haemorrhage (bleeding inside the brain). 
Zdravilo NovoSeven naj bi se uporabljalo za zdravljenje odraslih bolnikov z intracerebralno krvavitvijo (krvavitev znotraj možganov).
The CHMP normally takes up to 90 days (with the possibility to extend it to another 90 days) to adopt an opinion after it has received an application for a change to a marketing authorisation. 
CHMP po prejemu vloge za spremembo dovoljenja za promet navadno potrebuje do 90 dni (z možnostjo podaljšanja za dodatnih 90 dni), da poda svoje mnenje.
The Company has informed the CHMP that the current clinical trial of NovoSeven in intracerebral haemorrhage will continue. 
Podjetje je CHMP obvestilo, da se bodo trenutno potekajoča klinična preizkušanja z zdravilom NovoSeven pri znotrajmožganskih krvavitvah nadaljevala.
NovoSeven is currently used for the treatment and prevention of bleeding connected with surgery in patients with haemophilia who have developed ‘inhibitors' (antibodies) to factor VIII or IX. 
Zdravilo NovoSeven se trenutno uporablja za zdravljenje in preprečevanje krvavitev pri operacijah bolnikov s hemofilijo, ki so razvili “inhibitorje” (protitelesa) faktorjev VIII ali IX.
NovoSeven contains eptacog alfa (activated), which is a blood coagulation factor protein. 
NovoSeven vsebuje eptakog alfa (aktiviran), ki je beljakovinski krvni koagulacijski faktor.
In intracerebral haemorrhage, NovoSeven is expected to slow down the bleeding and the spread of the haemorrhage, thus improving the outcome for the patient. 
Pri znotrajmožganski krvavitvi naj bi zdravilo NovoSeven upočasnilo krvavitev in njeno širjenje, s čimer naj bi se izboljšal izid za bolnika.
NovoSeven is a powder and solvent for injection that contains the active substance eptacog alfa (activated human recombinant coagulation factor VII). 
Zdravilo NovoSeven je prašek in vehikel za raztopino za injiciranje, ki vsebuje zdravilno učinkovino eptakog alfa (aktivirani humani rekombinantni koagulacijski faktor VII).
NovoSeven was expected to limit the bleeding, and so reduce the consequences of the intracerebral haemorrhage. 
Zdravilo NovoSeven naj bi omejilo krvavitev in tako zmanjšalo posledice znotrajmožganske krvavitve.
In the body, eptacog alfa acts like one of the substances involved in blood coagulation (clotting), Factor VII. 
Eptakog alfa v telesu deluje na podoben način kot ena izmed snovi (faktor VII), ki sodelujejo pri koagulaciji (strjevanju) krvi.
What was NovoSeven expected to be used for this indication? 
Za kaj naj bi se zdravilo NovoSeven uporabljalo pri tej indikaciji?
How is NovoSeven expected to work in this indication? 
Kako naj bi se zdravilo NovoSeven uporabljalo pri tej indikaciji?
What is happening for NovoSeven used in other conditions? 
Kaj to pomeni za uporabo zdravila NovoSeven pri drugih indikacijah?
London, 27 April 2006 Doc.Ref. 
London, 27. april 2006 CHMP/154955/2006
The full EPAR for Entecavir Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Entekavir Mylan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Entecavir Mylan? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Entekavir Mylan?
This is a summary of the European public assessment report (EPAR) for Entecavir Mylan. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Entekavir Mylan.
Because Entecavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Entekavir Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Entecavir Mylan is taken once a day. 
Zdravilo Entekavir Mylan se jemlje enkrat na dan.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Baraclude, and do not need to be repeated for Entecavir Mylan. 
Študije o koristih in tveganjih zdravilne učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Baraclude, zato jih ni treba ponoviti za zdravilo Entekavir Mylan.