natgillin/translations-raw huggingface dataset:
For swine erysipelas, the first laboratory study showed that 90% (27 out of 30) of vaccinated pigs were protected against Erysipelothrix rhusiopathiae serotype 1 remaining free of specific skin lesions whilst 93% (28 out of 30) of vaccinated pigs were protected against Erysipelothrix rhusiopathiae serotype 2 remaining free of specific skin lesions. 
Pri svinjski rdečici je prva laboratorijska študija pokazala, da je bilo 90 % (27 od 30) cepljenih prašičev zaščitenih pred serotipom 1 bakterije Erysipelothrix rhusiopathiae, kar pomeni, da se pri njih niso pojavile specifične kožne lezije, pred serotipom 2 bakterije Erysipelothrix rhusiopathiae pa je bilo zaščitenih 93 % (28 od 30) cepljenih prašičev, kar prav tako pomeni, da se pri njih niso pojavile specifične kožne lezije.
When Eryseng Parvo is given to pigs the animals' immune system recognises the virus and bacteria as ‘foreign' and makes antibodies against them. 
Ko prašiče cepimo z zdravilom Eryseng Parvo, njihov imunski sistem virus in bakterije prepozna kot „tujke“ in proti njim razvije protitelesa.
Porcine parvovirus causes infertility, still births and small litters in sows (female pigs that have had piglets). 
Prašičji parvovirus povzroča neplodnost, mrtvorojenost in majhna legla pri svinjah (prašičjih samicah, ki so že prasile).
What benefit has Eryseng Parvo shown during the studies? 
Kakšne koristi je zdravilo Eryseng Parvo izkazalo med študijami?
Eryseng Parvo is a veterinary vaccine that contains inactivated (killed) porcine parvovirus and Erysipelothrix rhusiopathiae bacteria. 
Zdravilo Eryseng Parvo je cepivo za uporabo v veterinarski medicini, ki vsebuje inaktivirana (uničena) prašičji parvovirus in bakterijo Erysipelothrix rhusiopathiae.
It contains a strain of porcine parvovirus called NADL-2 and a strain of Erysipelothrix rhusiopathiae called R32E11. 
Vsebuje sev prašičjega parvovirusa NADL-2 in sev bakterije Erysipelothrix rhusiopathiae R32E11.
This will help protect them against porcine parvovirus and swine erysipelas. 
To bo pripomoglo k zaščiti prašičev pred prašičjo parvovirozo in svinjsko rdečico.
The second laboratory study showed 93% (14 out of 15) pigs were protected against challenge with Erysipelothrix rhusiopathiae serotypes 1 and 2. 
Druga laboratorijska študija je pokazala, da je bilo 93 % (14 od 15) samic zaščitenih pred serotipoma 1 in 2 bakterije Erysipelothrix rhusiopathiae.
Eryseng Parvo is also used to protect male and female pigs against swine erysipelas caused by Erysipelothrix rhusiopathiae, serotype 1 and serotype 2. 
Zdravilo Eryseng Parvo se uporablja tudi za zaščito prašičjih samcev in samic pred svinjsko rdečico, ki jo povzroča bakterija Erysipelothrix rhusiopathiae serotipa 1 in serotipa 2.
What is the risk associated with Eryseng Parvo? 
Kakšna tveganja so povezana z zdravilom Eryseng Parvo?
Porcine parvovirosis and swine erysipelas vaccine (inactivated) 
cepivo proti prašičji parvovirozi in svinjski rdečici (inaktivirano)
Eryseng Parvo is used to protect embryonic and foetal (unborn) piglets against porcine parvovirus infection via the placenta. 
Zdravilo Eryseng Parvo se uporablja za zaščito prašičjih zarodkov in fetusov (nerojenih pujskov) pred okužbo s prašičjim parvovirusom prek posteljice.
Why has Eryseng Parvo been approved? 
Zakaj je bilo zdravilo Eryseng Parvo odobreno?
The withdrawal period for Eryseng Parvo is zero days. 
Karenca za zdravilo Eryseng Parvo je nič dni.
What is Eryseng Parvo used for? 
Za kaj se zdravilo Eryseng Parvo uporablja?
How has Eryseng Parvo been studied? 
Kako je bilo zdravilo Eryseng Parvo raziskano?
What is Eryseng Parvo? 
Kaj je zdravilo Eryseng Parvo?
How does Eryseng Parvo work? 
Kako zdravilo Eryseng Parvo deluje?
Velmetia is taken twice a day. 
Zdravilo Velmetia se jemlje dvakrat na dan.
The European Commission granted a marketing authorisation valid throughout the EU for Velmetia on 16 July 2008. 
Evropska komisija je dovoljenje za promet z zdravilom Velmetia, veljavno po vsej Evropski uniji, odobrila dne 16. julija 2008.
The full EPAR for Velmetia 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 Velmetia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Velmetia. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Velmetia.
Other information about Velmetia 
Druge informacije o zdravilu Velmetia
It must also not be used in patients who consume excessive amounts of alcohol or who are alcoholic, or in women who are breast-feeding. 
Prav tako se ne sme uporabljati pri bolnikih, ki prekomerno uživajo alkohol ali so alkoholiki, ali pri doječih ženskah.
For more information about treatment with Velmetia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Velmetia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Velmetia sitagliptin / metformin hydrochloride 
Velmetia sitagliptin/metforminijev klorid
The most common side effect with Velmetia (seen in between 1 and 10 patients in 100) is nausea (feeling sick). 
Najpogostejši neželeni učinek zdravila Velmetia (opažen pri 1 do 10 bolnikih od 100) je navzeja (slabost).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Velmetia. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Velmetia, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What benefit has Velmetia shown during the studies? 
Kakšne koristi je zdravilo Velmetia izkazalo med študijami?
The CHMP decided that Velmetia's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Velmetia večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The results of three further studies were used to support the use of Velmetia. 
V podporo uporabi zdravila Velmetia so bili uporabljeni rezultati treh nadaljnjih študij.
If Velmetia is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered, to avoid hypoglycaemia (low blood sugar levels). 
Če se zdravilo Velmetia jemlje skupaj s sulfonilsečnino ali insulinom, bo morda treba odmerek sulfonilsečnine ali insulina zmanjšati, da ne bi prišlo do hipoglikemije (nizke ravni sladkorja v krvi).
Velmetia must not be used in people who are hypersensitive (allergic) to sitagliptin, metformin or any of the other ingredients. 
Zdravila Velmetia ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) sitagliptin, metformin ali katero koli drugo sestavino zdravila.
The company carried out additional studies to show that the active substances in Velmetia are absorbed by the body in the same way as the two medicines given separately. 
Družba je opravila še nadaljnje študije, da bi dokazala, da telo zdravilni učinkovini zdravila Velmetia absorbira na enak način, kot če sta vzeti v obliki ločenih zdravil.
Velmetia is a medicine that contains two active substances, sitagliptin and metformin hydrochloride. 
Velmetia je zdravilo, ki vsebuje dve zdravilni učinkovini, sitagliptin in metforminijev klorid.
Velmetia should be taken with food to avoid any stomach problems caused by metformin. 
Zdravilo Velmetia je treba jemati sočasno s hrano, da se preprečijo želodčne težave, ki jih povzroča metformin.
What is the risk associated with Velmetia? 
Kakšna tveganja so povezana z zdravilom Velmetia?
Velmetia is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels. 
Zdravilo Velmetia se uporablja za zdravljenje bolnikov s sladkorno boleznijo tipa 2 za izboljšanje nadzora nad ravnmi glukoze (sladkorja) v krvi.
For the full list of all side effects reported with Velmetia, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Velmetia, glejte navodilo za uporabo.
The first included 1,091 patients who were not satisfactorily controlled on diet and exercise alone and compared the effect of Velmetia with that of metformin or sitagliptin alone. 
V prvo je bilo vključenih 1 091 bolnikov, pri katerih zadosten nadzor ni bil dosežen zgolj z dieto in telesno vadbo, v njej pa so primerjali učinke zdravila Velmetia z učinki metformina ali sitagliptina, uporabljenih kot samostojni zdravili.
In the first of the three further studies, Velmetia was more effective than metformin or sitagliptin alone. 
V prvi od treh dodatnih študij je bilo zdravilo Velmetia učinkovitejše od metformina ali sitagliptina, uporabljenih kot samostojni zdravili.
Why has Velmetia been approved? 
Zakaj je bilo zdravilo Velmetia odobreno?
The active substances in Velmetia, sitagliptin and metformin hydrochloride, each have a different mode of action. 
Zdravilni učinkovini v zdravilu Velmetia, sitagliptin in metforminijev klorid, imata različna načina delovanja.
Velmetia was more effective than metformin alone. 
Zdravilo Velmetia je bilo učinkovitejše od metformina, uporabljenega kot samostojno zdravilo.
The company presented the results of three studies of Januvia/Xelevia to support the use of Velmetia in patients who were not satisfactorily controlled on their existing metformin treatment. 
Družba je v podporo uporabi zdravila Velmetia pri bolnikih, pri katerih obstoječe zdravljenje z metforminom bolezni ni zadostno za nadzor bolezni, predstavila rezultate treh študij z zdraviloma Januvia in Xelevia.
What is Velmetia used for? 
Za kaj se zdravilo Velmetia uporablja ?
How does Velmetia work? 
Kako zdravilo Velmetia deluje?
How has Velmetia been studied? 
Kako je bilo zdravilo Velmetia raziskano?
How is Velmetia used? 
Kako se zdravilo Velmetia uporablja?
What is Velmetia? 
Kaj je zdravilo Velmetia?
Ref.: EMEA/264546/2009 EMEA/H/C/770 
: EMEA/264546/2009 EMEA/H/C/770
The European Commission granted a marketing authorisation valid throughout the European Union for Avamys to Glaxo Group Ltd on 11 January 2008. 
Evropska komisija je dovoljenje za promet z zdravilom Avamys, veljavno po vsej Evropski uniji, odobrila družbi Glaxo Group Ltd dne 11. januarja 2008.
To get the most benefit from the medicine, it should be used regularly and at the same time every day. 
Največji učinek zdravila dosežemo, če zdravilo uporabljamo redno in vsak dan ob istem času.
Similar results were seen in children aged six years and above. 
Podobni rezultati so bili ugotovljeni pri otrocih, starih šest let in več.
Avamys fluticasone furoate EPAR summary for the public 
Avamys flutikazon furoat Povzetek EPAR za javnost
Other information about Avamys: 
Druge informacije o zdravilu Avamys:
The effects of Avamys were first tested in experimental models before being studied in humans. 
Učinki zdravila Avamys so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
However, it was not possible to determine if Avamys worked in children below the age of six years, because there were too few children below this age included the studies. 
Ni pa bilo mogoče ugotoviti, ali je zdravilo Avamys delovalo tudi pri otrocih, starih manj kot šest let, ker je bilo v študije vključenih premalo otrok iz te starostne skupine.
This leads to a reduction the release of substances that are involved in the inflammation process, such as histamine, reducing the symptoms of allergy. 
Posledica tega je zmanjšano sproščanje snovi, ki sodelujejo v vnetnem procesu, kot je histamin, kar privede do zmanjšanja simptomov alergije.
It usually starts to work from eight hours after the first spray, but it may take several days to get the maximum benefit. 
Zdravilo običajno začne delovati po osmih urah po prvi uporabi, vendar pa se največji učinek lahko pokaže šele nekaj dni po začetku zdravljenja.
It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell. 
Ta deluje na podoben način kot naravno prisotni kortikosteroidni hormoni, in sicer tako, da z vezavo na receptorje različnih imunskih celic zmanjšuje delovanje imunskega sistema.
The Committee recommended that Avamys be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Avamys odobri dovoljenje za promet.
The lowest effective dose that keeps symptoms controlled should be used. 
Uporabiti je treba najmanjši odmerek, ki še nadzoruje simptome.
The most common side effect with Avamys (seen in more than 1 patient in 10) is epistaxis (nosebleeds). 
Najpogostejši neželeni učinek zdravila Avamys (opažen pri več kot 1 bolniku izmed 10) je epistaksa (krvavitve iz nosu).
The active substance in Avamys, fluticasone furoate, is a corticosteroid. 
Zdravilna učinkovina v zdravilu Avamys, flutikazon furoat, je kortikosteroid.
This is generally mild or moderate and tends to affect adults who have used Avamys for more than six weeks. 
Te so ponavadi blage do zmerne in so pogostejše pri odraslih, ki so uporabljali zdravilo Avamys več kot šest tednov.
What benefit has Avamys shown during the studies? 
Kakšne koristi je zdravilo Avamys izkazalo med študijami?
Avamys was compared with placebo (a dummy treatment) in six main studies involving almost 2,500 patients. 
Zdravilo Avamys so primerjali s placebom (zdravilom brez zdravilne učinkovine) v šestih glavnih študijah, v katere je bilo vključenih skoraj 2 500 bolnikov.
Avamys should only be used for as long as the patient is exposed to the allergen, such as pollen, house dust mites or other animals. 
Zdravilo Avamys se lahko uporablja samo, dokler je bolnik izpostavljen alergenom, kot so cvetni prah, hišne pršice in druge živali.
The recommended dose of Avamys for patients aged 12 years and over is two sprays in each nostril once a day. 
Priporočeni odmerek zdravila Avamys pri bolnikih, starih 12 let in več, je dva vpiha v vsako nosnico enkrat dnevno.
The other two studies were carried out in children aged between two and 11 years: the first involved 558 children with perennial allergic rhinitis and the second involved 554 children with seasonal allergic rhinitis. 
Preostali dve študiji sta bili opravljeni pri otrocih, starih od dve do 11 let: v prvo študijo je bilo vključenih 558 otrok s celoletnim alergijskim rinitisom, v drugo pa 554 otrok s sezonskim alergijskim rinitisom.
This is inflammation of the nasal passages caused by an allergy, resulting in runny nose, blocked nose, itching and sneezing. 
To je vnetje nosne votline, ki ga povzroči alergija in ima za posledico izcedek iz nosu, zamašen nos, srbenje in kihanje.
What is the risk associated with Avamys? 
Kakšna tveganja so povezana z zdravilom Avamys?
For the full list of all side effects reported with Avamys, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Avamys, glejte navodilo za uporabo.
For children between six and 12 years of age, the recommended dose is one spray in each nostril once a day, although this can be increased to two sprays if symptoms are not controlled. 
Pri otrocih, starih med šest in 12 let, je priporočeni odmerek en vpih v vsako nosnico enkrat dnevno, če pa s tem odmerkom ne moremo vzpostaviti nadzora nad simptomi, ga lahko zvišamo na dva vpiha.
Avamys should not be used in people who are allergic to fluticasone furoate or any of the other ingredients. 
Zdravila Avamys ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) flutikazon furoat ali katero koli drugo sestavino zdravila.
It is often accompanied by symptoms affecting the eyes, such as irritation, watering or redness. 
Spremljajo ga simptomi, ki prizadenejo oči, kot je draženje, solzenje ali pordelost.
Avamys is used to treat the symptoms of allergic rhinitis. 
Zdravilo Avamys se uporablja za zdravljenje simptomov alergijskega rinitisa.
In the studies of seasonal allergic rhinitis in patients aged 12 years or over, Avamys reduced symptom scores from around 9 points at the start of the study by between 3.6 and 5.4 points over two weeks, compared with a reduction of 2.3 to 3.7 points with placebo. 
V študijah sezonskega alergijskega rinitisa pri bolnikih, starejših od 12 let, je zdravilo Avamys v dveh tednih za 3,6 do 5,4 točke zmanjšalo izhodiščno vrednost simptomov, ki je znašala približno 9 točk, v primerjavi z zmanjšanjem za 2,3 do 3,7 točke pri placebu.
In the study of perennial allergic rhinitis, Avamys had reduced scores by 3.6 points after four weeks, compared with a reduction of 2.8 points with placebo. 
V študiji celoletnega alergijskega rinitisa je zdravilo Avamys po štirih tednih zmanjšalo vrednosti za 3,6 točke v primerjavi z zmanjšanjem za 2,8 točke pri placebu.
Avamys is for use in patients aged six years and over. 
Zdravilo Avamys se uporablja pri bolnikih, starih šest let in več.
The Committee for Medicinal Products for Human Use (CHMP) decided that Avamys's benefits are greater than its risks for the treatment of the symptoms of allergic rhinitis in patients aged six years or over. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Avamys pri zdravljenju simptomov alergijskega rinitisa pri bolnikih, starih šest let in več, večje od z njim povezanih tveganj.
Why has Avamys been approved? 
Zakaj je bilo zdravilo Avamys odobreno?
Avamys is a nasal spray that contains the active substance fluticasone furoate. 
Avamys je pršilo za nos, ki vsebuje zdravilno učinkovino flutikazon furoat.
The full EPAR for Avamys can be found here. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Avamys je na voljo tukaj.
The first four studies looked at Avamys used in patients aged 12 years or over: three were short-term studies lasting two weeks and involved a total of 886 patients with seasonal allergic rhinitis 
Prve štiri študije so proučevale uporabo zdravila Avamys pri bolnikih, starih 12 let in več: tri študije so bile kratkotrajne, trajale so dva tedna in vključevale 886 bolnikov s sezonskim alergijskim rinitisom (senenim nahodom), medtem ko je četrta trajala štiri tedne in vključevala 302 bolnika s celoletnimi (nesezonskimi alergijami), kot so alergije na živali.
In all of the studies, the main measure of effectiveness was the change in four symptoms of allergy affecting the nose. 
V vseh študijah je bilo glavno merilo učinkovitosti sprememba štirih simptomov alergije, ki prizadenejo nos. Vsak simptom so merili na lestvici od 0 do 3, pri čemer je najvišji skupni rezultat znašal 12 točk.
Avamys was more effective than placebo at reducing symptoms of allergic rhinitis in patients aged six years and over. 
Zdravilo Avamys je bilo pri zmanjševanju simptomov alergijskega rinitisa pri bolnikih, starih šest let in več, učinkovitejše od placeba.
What is Avamys used for? 
Za kaj se zdravilo Avamys uporablja?
This can be reduced to one spray in each nostril once symptoms are controlled. 
Ko vzpostavimo nadzor nad simptomi, lahko ta odmerek zmanjšamo na en vpih v vsako nosnico.
How has Avamys been studied? 
Kako je bilo zdravilo Avamys raziskano?
What is Avamys? 
Kaj je zdravilo Avamys?
How is Avamys used? 
Kako se zdravilo Avamys uporablja?
How does Avamys work? 
Kako zdravilo Avamys deluje?
• cooperating with international partners and contributing to international activities; 
• sodelovanju z mednarodnimi partnerji in prispevanju k mednarodnim dejavnostim;
• successfully implementing tasks vested by new legislation; 
• uspešnemu izvajanju nalog, ki jih zagotavlja nova zakonodaja;
Therefore, the volume of activities, as well as their complexity, is growing from year to year, and has to be accommodated by the Agency and its network of partners. 
Zato se obseg dejavnosti, kakor tudi njihova kompleksnost, iz leta v leto povečujeta, čemur se morata prilagoditi agencija in njena mreža partnerjev.
The work programme for 2010 is set against a dynamic background of changes in the Agency's legislative and business environment. 
Delovni program za leto 2010 temelji na dinamičnem ozadju sprememb v zakonodajnem in poslovnem okolju agencije.
As in previous years, significant attention will be given to further work in the field of safety-monitoring of medicines. 
Kot prejšnja leta bo posebna pozornost posvečena nadaljnjemu delu na področju spremljanja varnosti zdravil.
Following the recent legislation on advanced therapy medicinal products, a number of additional legislative changes have already come into effect, or will soon. 
Zaradi najnovejše zakonodaje o zdravilih za napredno zdravljenje so že ali bodo kmalu začele veljati številne dodatne zakonodajne spremembe.
• strengthening the European medicines network; 
• okrepitvi Evropske mreže zdravil;
Implementation of the new remuneration system may take place in 2010, following the pilot project completed in 2009. 
Izvajanje novega sistema nadomestil bi se lahko začelo leta 2010 na podlagi pilotnega projekta, zaključenega leta 2009.
• contributing to an environment that stimulates innovation and improved availability of medicines. 
• prispevanju k okolju, v katerem se spodbujajo inovacije in boljša razpoložljivost zdravil.
The global nature of drug development and research, coupled with the high regard of the Agency in the international arena, mean that the Agency's international commitments will not only remain high on its agenda, but will also grow in importance and volume. 
Svetovna narava razvoja in raziskav zdravil skupaj z visokim ugledom agencije na mednarodnem prizorišču pomeni, da mednarodna zavezanost agencije ne bo samo ostala pomembna prednostna naloga njenega programa, ampak bo pridobila na njenem pomenu in obsegu.
This year completes the implementation of the Agency's longterm strategy (Road Map to 2010) adopted by the Management Board in December 2004, and lays the ground for the new strategy document, which will span to 2015. 
Letos se zaključuje izvajanje dolgoročne strategije agencije (Strateškega načrta do leta 2010), ki ga je upravni odbor sprejel decembra 2004, pripravlja pa se tudi podlaga za nov strateški dokument, ki bo zajemal obdobje do leta 2015.
• conducting the Agency's core activities to the highest quality standards, amid the increasing volume and complexity of activities; 
• izvajanju osnovnih dejavnosti agencije v skladu z najvišjimi standardi kakovosti, ob povečanju obsega in kompleksnosti dejavnosti;
• fostering communication, provision of information and increasing transparency; 
• spodbujanju obveščanja, zagotavljanja informacij in povečanju preglednosti;
The Agency will also commence preparations for possible future legislative changes in the areas of pharmacovigilance and counterfeit medicines. 
Agencija bo prav tako začela priprave na morebitne prihodnje zakonodajne spremembe na področju farmakovigilance in ponarejanja zdravil.
The same challenges that affect the Agency also affect the network, amid growing pressure on scientific resources of the national competent authorities. 
Enaki izzivi, ki bodo vplivali na agencijo, bodo vplivali tudi na mrežo, pri čemer bodo nacionalni pristojni organi izvajali vedno večji pritisk na znanstvene vire.
Work programme 2010 of the European Medicines Agency 
Delovni program Evropske agencije za zdravila za leto
• continuing to improve the safety-monitoring of medicines; 
• nadaljnjemu izboljšanju spremljanja varnosti zdravil;
The Agency will start implementing its Transparency Policy, developed in 2009, and will continue discussions within the EU regulatory network to have, as far as possible, a common approach in the field of transparency. 
Prav tako bo agencija začela izvajati politiko preglednosti, ki jo je pripravila leta 2009, in bo nadaljevala razprave znotraj regulativne mreže EU, da bi čim prej razvili skupni pristop na področju preglednosti.