natgillin/translations-raw huggingface dataset:
Annex II Scientific conclusions and grounds for variation to the terms of the marketing authorisations subject to conditions and detailed explanation of the scientific grounds for the differences from the PRAC recommendation 
Priloga II Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom pod določenimi pogoji ter podrobna obrazložitev znanstvene podlage za odstopanja od priporočila odbora PRAC
Overall the PRAC concluded that the findings in the literature do not consistently show an increased risk of cardiovascular events and do not corroborate the signal of an increased risk of cardiovascular events associated with testosterone therapy. 
Na splošno je odbor PRAC sklenil, da so ugotovitve v literaturi glede povečanega tveganja kardiovaskularnih dogodkov nedosledne in ne podpirajo poročanja o povečanem tveganju kardiovaskularnih dogodkov, povezanih z zdravljenjem s testosteronom.
The major goal of testosterone therapy (TT) is to achieve normal physiological levels of testosterone levels to relieve symptoms of hypogonadism like decreased sexual function, infertility, decreased energy, depressed mood, mild anaemia, reduced muscle bulk and strength, increased body fat and body mass index (BMI) and psychological impairment. 
Glavni cilj zdravljenja s testosteronom je doseči normalne fiziološke ravni testosterona, s čimer se olajšajo simptomi hipogonadizma, kot so zmanjšana spolna funkcija, neplodnost, zmanjšana energija, depresivno razpoloženje, blaga anemija, zmanjšana mišična masa in moč, povečana telesna maščoba ter indeks telesne mase (ITM) in poslabšanje duševne funkcije.
2 - Detailed explanation of the scientific grounds for differences from the PRAC recommendation 
2 - Podrobna obrazložitev znanstvenih razlogov za odstopanja od priporočila PRAC
In view of the above, the PRAC has recommended the variation to the terms of the Marketing Authorisations for testosterone-containing medicinal products (see Annex I), for which the relevant sections of the Summary of Product Characteristics and Package Leaflet are set out in Annex III and subject to the conditions set out in Annex IV of the PRAC recommendation. 
Na podlagi zgornje razprave je odbor PRAC priporočil spremembe pogojev dovoljenj za promet z zdravili, ki vsebujejo testosteron (glejte Prilogo I), ki so za ustrezna poglavja povzetka glavnih značilnosti zdravila ter navodila za uporabo navedene v Prilogi III in so predmet pogojev, določenih v Prilogi IV priporočila odbora PRAC.
Testosterone should be used with caution in men with hypertension and testosterone levels should be monitored both at baseline and at regular intervals during treatment to ensure the adequacy of the dose administered. 
Ravni testosterona je treba spremljati ob izhodišču in v rednih presledkih med zdravljenjem, da se zagotovi zadostnost uporabljenega odmerka.
Hypogonadism is classified into primary testicular failure due to a problem in the testicles and secondary testicular failure, due to a problem in the hypothalamus or the pituitary gland. 
Hipogonadizem je razvrščen kot primarna testikularna odpoved zaradi težave v modih in sekundarna testikularna odpoved zaradi težav v hipotalamusu ali hipofizi.
All testosterone-containing medicinal products approved in the European Union were included in this review performed by the PRAC. 
V ta pregled, ki ga je opravil odbor PRAC, so bila vključena vsa zdravila, ki vsebujejo testosteron in so odobrena v Evropski uniji.
• The Committee recognised the limited available information on testosterone therapy for agerelated hypogonadism and also the lack of reference values. 
• odbor je upošteval omejene razpoložljive podatke o zdravljenju s testosteronom pri hipogonadizmu, povezanem s starostjo, in pomanjkanje referenčnih vrednosti.
knowledge to date, the PRAC recommended that the possible mechanism on the association between cardiovascular/venous thromboembolic events and the level of testosterone be further investigated by the marketing authorisation holders and reported at the next PSUR. 
Na podlagi trenutnega znanja je odbor PRAC priporočil, da morajo imetniki dovoljenj za promet z zdravilom dodatno raziskati morebitne mehanizme glede povezave med kardiovaskularnimi/venskimi trombemboličnimi dogodki in ravnijo testosterona in o njih poročati v naslednjem poročilu PSUR.
• The PRAC concluded that based on the overall currently available data, the suggested risk for cardiovascular events associated with the testosterone therapy remains a weak signal. 
• odbor PRAC je sklenil, da na podlagi celotnih trenutno razpoložljivih podatkov zadevno tveganje kardiovaskularnih neželenih dogodkov, povezanih z zdravljenjem s testosteronom, ostaja šibek pomislek.
3 Finkle et al. “Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men.” PLoS One. 
J Sex Med 2013;10:245-284. 3 Finkle et al. “Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men.” PLoS One.
All were authorised nationally and are available in different pharmaceutical forms: solution for intramuscular injection, oral capsules, cutaneous gel, cutaneous solution and transdermal patch. 
farmacevtskih oblikah: raztopina za intramuskularno injiciranje, peroralne kapsule, dermalni gel, dermalna raztopina in transdermalni obliž.
Xu L, Freeman G, Cowling BJ,Schooling CM. Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials. 
2013 Nov 6;310(17):1829-36. 5 Xu L, Freeman G, Cowling BJ,Schooling CM. Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials.
• The Committee noted that the available data does not consistently show an increased risk of cardiovascular events during testosterone therapy. 
• odbor je ugotovil, da razpoložljivi podatki o povečanem tveganju kardiovaskularnih dogodkov med zdravljenjem s testosteronom niso dosledni;
The symptoms are less specific if the hypogonadism develops after puberty and are characterized by e.g. decreased sexual function, infertility, decreased energy, depressed mood, mild anaemia, reduced muscle bulk and strength, increase body fat and BMI (guideline of Endocrine Society). 
Za tako vrsto hipogonadizma so na primer značilni zmanjšana spolna funkcija, neplodnost, zmanjšana energija, depresivno razpoloženje, blaga anemija, zmanjšana mišična masa in moč, povečana telesna maščoba in ITM (smernica Združenja za endokrinologijo).
There are no treatment alternatives to testosterone for male hypogonadism (Buvat et al. 20132) 
Pri zdravljenju moškega hipogonadizma razen testosterona ne obstajajo nobene druge oblike zdravljenja (Buvat in sod.
Concerns were raised with regards to a potential increased risk of cardiovascular events, namely myocardial infarction, in men treated with testosterone and who have pre-existing heart disease (Finkle et al, 20143; Vigen et al, 20134 and Xu et al, 20135). 
Pojavili so se pomisleki glede morebitnega povečanega tveganja kardiovaskularnih dogodkov, predvsem miokardnega infarkta, pri moških s srčno boleznijo, zdravljenih s testosteronom (Finkle in sod.
This summary was last updated in March 2016 
Povzetek je bil nazadnje posodobljen marca 2016.
Protection starts four weeks after vaccination. 
Zaščita se vzpostavi štiri tedne po cepljenju.
‘Attenuated' means that the strain has first been weakened so that it does not cause disease. 
„Oslabljen“ pomeni, da je bil sev najprej oslabljen, tako da ne povzroča bolezni.
The company presented data from laboratory studies and from one field trial. 
Družba je predstavila podatke iz laboratorijskih študij in enega terenskega preskušanja.
The field study did not bring additional information. 
S terenskimi študijami niso pridobili nobenih novih informacij.
The full EPAR for MS-H Vaccine can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni cepiva MS-H je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The whole flock should be vaccinated at the same time. 
Vse ptice v jati morajo biti cepljene hkrati.
This is a summary of the European public assessment report (EPAR) for MS-H Vaccine. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za cepivo MS-H.
Protection against damage to air sacs lasts for 40 weeks, but the duration of protection against abnormal shells forming is not known. 
Zaščita pred poškodbami zračnih mešičkov traja 40 tednov, trajanje zaščite pred nenormalno oblikovano lupino pa ni znano.
The European Commission granted a marketing authorisation valid throughout the European Union, for MS-H vaccine on 14 June 2011. 
Evropska komisija je dovoljenje za promet s cepivom MS-H, veljavno po vsej Evropski uniji, izdala 14. junija 2011.
It should not be used in birds in lay or within five weeks of the start of the laying period. 
Ne sme se uporabljati pri pticah v obdobju nesnosti ali pet tednov pred začetkom obdobja nesnosti.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that MS-H Vaccine's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi cepiva MS-H večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The vaccine has no known side effects. 
Za cepivo niso znani nobeni neželeni učinki.
In the future, if the animals are exposed to Mycoplasma synoviae, the immune system will be able to respond more quickly. 
Če bo žival v prihodnosti ponovno izpostavljena bakteriji Mycoplasma synoviae, se bo imunski sistem lahko tako hitreje odzval.
The person administering the vaccine should wear protective equipment, consisting of gloves and safety glasses to avoid skin and eye injuries which may occur by manipulating the vaccine bottle which is frozen. 
Oseba, ki daje zdravilo, mora nositi zaščitno opremo, ki vključuje zaščitne rokavice in očala, ki preprečujejo poškodbe kože in oči, do katerih lahko pride pri rokovanju z zamrznjeno stekleničko cepiva.
This bacterium causes infections in birds, generally in the lungs and the ‘air sacs', the specialised bags within the bird's body where air is stored during breathing. 
Ta bakterija povzroča okužbe pri ptičih, predvsem v pljučih in „zračnih mešičkih“, tj. posebnih vrečkah v telesu ptičev, v katerih se shranjuje zrak med dihanjem.
MS-H Vaccine, like all vaccines, works by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease. 
Cepivo MS-H kot vsa druga cepiva deluje tako, da imunski sistem (naravni obrambni mehanizem telesa) „nauči“, kako naj se brani pred boleznijo.
Other information about MS-H Vaccine: 
Druge informacije o cepivu MS-H:
MS-H Vaccine is given as one eye drop into one eye. 
Cepivo MS-H se daje kot ena kapljica v eno oko.
MS-H Vaccine is used in young chickens intended to produce eggs for broilers (for meat) and layers (for egg production) to reduce the damage to air sacs and reduce the number of eggs with abnormal shells. 
Cepivo MS-H se uporablja pri mladih piščancih, namenjenih za vzrejo brojlerjev (za meso) in nesnic (za proizvodnjo jajc), za zmanjševanje poškodb na zračnih mešičkih in zniževanje števila jajc z nenormalno oblikovano lupino.
When MS-H Vaccine is given to chickens the immune system recognises the weakened strain as ‘foreign' and makes defences against it. 
Po cepljenju piščancev s cepivom MS-H imunski sistem prepozna oslabljeni sev kot „tujek“ in proti njemu vzpostavi obrambo.
Infection with Mycoplasma synoviae may result in difficulty breathing and is also associated with poor quality of the eggshell. 
Okužbe z bakterijo Mycoplasma synoviae lahko privedejo do oteženega dihanja, povezane pa so tudi s slabo kakovostjo jajčnih lupin.
What is MS-H Vaccine and what is it used for? 
Kaj je cepivo MS-H in za kaj se uporablja?
What are the risks associated with MS-H Vaccine? 
Kakšna tveganja so povezana s cepivom MS-H?
MS-H Vaccine is available as eye drops and can only be obtained with a prescription. 
Cepivo MS-H je na voljo v obliki kapljic za oko in se izdaja le na recept.
MS-H Vaccine 
Cepivo MS-H
The laboratory studies showed that MS-H Vaccine reduces damage to the air sacs and reduces the number of eggs with shell abnormalities. 
Laboratorijske študije so pokazale, da cepivo MS-H zmanjšuje poškodbe zračnih mešičkov in znižuje število jajc z nenormalno oblikovano lupino.
The laboratory studies included a challenge model of Mycoplasma synoviae infection as well as a study looking at the effect of vaccination on eggshell abnormalities. 
Laboratorijske študije so vključevale tudi provokacijski model okužbe z bakterijo Mycoplasma synoviae in študijo, s katero so proučevali učinek cepljenja na nenormalno oblikovane jajčne lupine.
What benefits of MS-H Vaccine have been shown in studies? 
Kakšne koristi je cepivo MS-H izkazalo v študijah?
For practical information about using MS-H Vaccine, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za praktične informacije o uporabi cepiva MS-H naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For more information about treatment with MS-H Vaccine, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za več informacij o zdravljenju s cepivom MS-H naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Mycoplasma synoviae strain MS-H vaccine (live attenuated) 
cepivo proti sevu bakterije Mycoplasma synoviae MS-H (živo, oslabljeno)
MS-H Vaccine is a vaccine used in chickens from five weeks of age to protect them against Mycoplasma synoviae. 
Cepivo MS-H se uporablja pri piščancih, starih pet tednov in več, za zaščito pred bakterijo Mycoplasma synoviae.
Why is MS-H Vaccine approved? 
Zakaj je bilo cepivo MS-H odobreno?
Any accidental splashing to the face and eyes should be thoroughly washed with water. 
Če cepivo nenamerno oškropi oči ali obraz osebe, ki daje zdravilo, je treba oči in obraz temeljito sprati z vodo.
The field study looked at how vaccinated chickens fared when moved to flocks with a history of Mycoplasma synoviae infection. 
S terensko študijo so proučevali, kako so se cepljeni piščanci odzvali, ko so jih preselili v jato, pri kateri so se v preteklosti pojavljale okužbe z bakterijo Mycoplasma synoviae.
MS-H Vaccine contains a live, attenuated strain of Mycoplasma synoviae. 
Cepivo MS-H vsebuje živ oslabljen sev bakterije Mycoplasma synoviae.
The withdrawal period for MS-H vaccine for meat and eggs is zero days. 
Karenca za meso in jajca po cepljenju s cepivom MS-H je nič dni.
It is not intended to provide practical advice on how to use MS-H Vaccine. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
How is MS-H Vaccine used? 
Kako se cepivo MS-H uporablja?
How does MS-H Vaccine work? 
Kako cepivo MS-H deluje?
Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/114) 
Izid postopka v skladu s členom 34 Direktive 2001/82/ES (EMEA/V/A/114)
14 July 2017 
14. julij 2017
The European Commission issued a decision on 14 July 2017. 
Evropska komisija je sklep izdala 14. julija 2017.
Denagard 45% (and associated names such as Tiamutin 45%, Denagard 450 mg/g and Denagard vet 450 mg/g) is marketed in Austria, Belgium, Czech Republic, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Poland, Portugal, Romania, Slovak Republic and Spain. 
Zdravilo Denagard 45% (in povezana imena, kot so Tiamutin 45%, Denagard 450 mg/g in Denagard vet 450 mg/g) se trži v Avstriji, Belgiji, na Češkem, Finskem, v Nemčiji, Grčiji, na Madžarskem, v Italiji, Latviji, Litvi, na Nizozemskem, Poljskem, Portugalskem, v Romuniji, na Slovaškem in v Španiji.
Denagard 45% is authorised in the EU via national procedures. 
Zdravilo Denagard 45% je bilo v EU odobreno po nacionalnih postopkih.
Tiamulin is a semi-synthetic antibiotic belonging to the pleuromutilin group of antibiotics and works by inhibiting bacterial protein synthesis. 
Tiamulin je polsintetični antibiotik, ki spada v skupino plevromutilinskih antibiotikov in zavira sintezo bakterijskih beljakovin.
On 12 April 2017, the European Medicines Agency (the Agency) completed a review of Denagard 45%. 
Evropska agencija za zdravila (agencija) je 12. aprila 2017 zaključila pregled zdravila Denagard 45%.
Questions and answers on Denagard 45% and its associated names 
Vprašanja in odgovori v zvezi z zdravilom Denagard 45% in povezanimi imeni
Questions and answers on Denagard 45% and its associated names EMA/275123/2017 
Vprašanja in odgovori v zvezi z zdravilom Denagard 45% in povezanimi imeni EMA/491902/2017
Denagard 45% is a veterinary medicinal product available as granules for use in drinking water and contains 450 mg tiamulin hydrogen fumarate per gram product. 
Zdravilo Denagard 45% je zdravilo za uporabo v veterinarski medicini, na voljo v obliki zrnc za uporabo v pitni vodi, ki vsebuje 450 mg tiamulinijevega hidrogenfumarata na gram zdravila.
Denagard 45% is indicated for the treatment of swine dysentery, colitis, ileitis, enzootic pneumonia and pleuropneumonia in pigs; chronic respiratory disease in chickens and infectious sinusitis and airsacculitis in turkeys. 
Zdravilo Denagard 45% je indicirano za zdravljenje prašičje dizenterije, kolitisa, ileitisa, enzootske pljučnice in plevropnevmonije pri prašičih, kronične respiratorne bolezni pri piščancih ter infekcijskega sinusitisa in vnetja zračnih vrečk pri puranih.
Why was Denagard 45% reviewed? 
Zakaj je bilo zdravilo Denagard 45% pregledano?
Germany noted that there are divergences across Member States in the way the veterinary medicinal product can be used, as seen in the differences in the product information in the countries where Denagard 45% is marketed. 
Nemčija je opozorila, da med državami članicami obstajajo razlike v načinu, kako se zdravilo za uporabo v veterinarski medicini lahko uporablja, kar se odraža v razlikah med povzetki glavnih značilnosti zdravila v državah, kjer se zdravilo Denagard 45% trži.
Based on the evaluation of the currently-available data, the CVMP concluded that the product information for Denagard 45% and its associated names should be harmonised across the EU. 
Odbor CVMP je na podlagi vrednotenja trenutno razpoložljivih podatkov zaključil, da je treba informacije o zdravilu za zdravilo Denagard 45% in povezana imena uskladiti po vsej EU.
What is Denagard 45%? 
Kaj je zdravilo Denagard 45%?
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that there is a need to harmonise the product information (summary of product characteristics (SPC), labelling and package leaflet) for Denagard 45% in the European Union (EU). 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da je treba uskladiti informacije o zdravilu (povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo) za zdravilo Denagard 45% v Evropski uniji (EU).
The amended product information is available on the 'All documents' tab. 
Popravljene informacije o zdravilu so na voljo pod zavihkom
On 24 August 2016, Germany referred the matter to the CVMP in order to harmonise the product information for Denagard 45% (and associated names) in the EU. 
Nemčija je za uskladitev informacij o zdravilu za zdravilo Denagard 45% (in povezana imena) 24. avgusta 2016 zadevo napotila na odbor CVMP.
In addition, the EC requested the Agency to give its opinion, as to whether provisional measures were necessary to protect public health. 
Poleg tega je Evropska komisija agencijo zaprosila za mnenje, ali so potrebni začasni ukrepi za zaščito javnega zdravja.
The adequacy of these provisional measures will be reviewed as part of the ongoing Article 20. 
Presoja ustreznosti teh začasnih ukrepov bo opravljena kot dela potekajočega postopka iz člena 20.
Therefore, monitoring of serum transaminases levels should continue to be performed at least monthly and more frequently as clinically indicated, further, bilirubin levels should also be tested. 
Zato je treba še dalje spremljati ravni transaminaz v serumu najmanj mesečno oziroma pogosteje, v kolikor za to obstajajo klinične indikacije, poleg tega pa je treba preverjati tudi ravni bilirubina.
The current recommendation relates only to provisional measures recommended by the PRAC for daclizumab based on the preliminary data available at this time. 
Trenutno priporočilo se nanaša zgolj na ukrepe, katere za daklizumab priporoča odbor PRAC na osnovi predhodnih podatkov, ki so ob tem času na voljo.
• The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, in particular regarding the need for provisional measures in accordance with Article 20(3) of Regulation (EC) No 726/2004 for Zinbryta (daclizumab). 
• Odbor PRAC je upošteval postopek iz člena 20 Uredbe (ES) št. 726/2004, ki je bil sprožen na podlagi farmakovigilančnih podatkov, zlasti zaradi potrebe po uvedbi začasnih ukrepov v skladu s členom 20(3) Uredbe (ES) št. 726/2004 za zdravilo Zinbryta (daklizumab).
While liver function monitoring continues to be an important measure to detect liver injury, and likely reduce the incidence of severe cases, it is unclear at this stage whether any alternative monitoring regimen would necessarily prevent further severe cases. 
Čeprav spremljanje funkcije jeter še dalje ostaja pomemben ukrep za odkrivanje morebitne poškodbe jeter in je verjetno, da bo zmanjšalo število resnih primerov, ni povsem jasno, ali je na tej stopnji potrebno uvesti še kakšen drug režim spremljanja za namen preprečevanja nadaljnjih resnih primerov.
On 9 June 2017 the EC therefore triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of Zinbryta (daclizumab) and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked. 
Zato je Evropska komisija 9. junija 2016 na podlagi farmakovigilančnih podatkov sprožila postopek v skladu z členom 20 Uredbe (ES) št. 726/2004 in odbor PRAC zaprosila, naj oceni vpliv zgoraj navedenih pomislekov na razmerje med tveganji in koristmi zdravila Zinbryta (daklizumab) ter izda priporočilo o tem, ali naj se ustrezna dovoljenja za promet z zdravilom ohranijo, spremenijo, začasno umaknejo ali ukinejo.
The threshold of transaminases elevation for patients not included in clinical trials, and therefore in which treatment initiation is not recommended, should be corrected from above two times the upper normal limit to above or equal to two times that limit. 
Prag dviga vrednosti transaminaz pri bolnikih, ki niso vključeni v klinična preskušanja, in zato pri njih uvedba zdravljenja ni priporočena, je treba popraviti z več kot dvakratne vrednosti zgornje normalne meje na več ali enako dvakratni vrednosti te meje.
Since the initial marketing authorisation further serious cases of liver injury have been reported, including a fatal case despite an attempted liver transplant. 
Od izdaje prvotnega dovoljenja za promet so bili zabeleženi nadaljnji primeri resne poškodbe jeter, vključno s smrtnim primerom, ki se je zgodil kljub poskusu presaditve jeter.
In the fatal case under review, the finding of normal serum transaminases levels prior to the dose of daclizumab did not prevent the occurrence of liver failure. 
Pri smrtnem primeru, ki je sedaj v preiskavi, ugotovitev normalnih ravni transaminaz v serumu pred dajanjem odmerka daklizumaba ni preprečila pojava odpovedi jeter.