natgillin/translations-raw huggingface dataset:
These innovative medicines offer groundbreaking new treatment opportunities for diseases and injuries of the human body. 
Ta inovativna zdravila ponujajo revolucionarne možnosti zdravljenja za bolezni in poškodbe človeškega telesa.
The implementation and development of EudraVigilance Veterinary (EVVet) continued in 2009. 
V letu 2009 se je nadaljevala uvedba in razvoj sistema EudraVigilance Veterinary.
In cooperation with King's College London, the Agency initiated a study on its benefit-risk communication activities, aimed at describing the Agency's approach to benefit-risk communication and identifying proposals for future implementation. 
Agencija je v sodelovanju z univerzo King's College iz Londona začela študijo o svojem obveščanju o koristih in tveganjih, katere cilj je bil opisati pristop agencije k obveščanju o koristih in tveganjih ter oblikovati predloge za prihodnje ukrepe.
The third medicine, another gene-therapy product, was withdrawn by the applicant prior to the adoption of a final opinion by the CHMP. 
Vlogo za tretje zdravilo, še eno zdravilo na podlagi genske terapije, je predlagatelj umaknil, preden je CHMP sprejel končno mnenje.
Bilateral relations with the US Food and Drug Administration (FDA) and the Japanese authorities were greatly enhanced when the notion of liaison placements was agreed. 
Dvostranski odnosi med ameriško upravo za živila in zdravila (FDA) ter japonskim pristojnim organom je bistveno pospešil dogovor o imenovanju uradnika za zvezo.
A large part of their work in 2009 was dedicated to implementing and further developing the regulatory framework for ATMPs by drafting procedural and scientific guidelines for public consultation, and to helping applicants prepare their applications for procedures introduced by the new legislation. 
Velik del njihovega dela je bil v letu 2009 namenjen uvedbi in dodatnem razvoju regulativnega okvira za zdravila za napredno zdravljenje s pripravo postopkovnih in znanstvenih smernic za javno razpravo ter pomoči predlagateljem pri pripravi vlog za postopke, ki jih uvaja nova zakonodaja.
In August 2009, the Agency signed its latest confidentiality arrangement with the Australian Therapeutic Goods Administration (TGA), bringing the number of confidentiality arrangements in place to four. 
Avgusta leta 2009 je agencija podpisala svojo zadnjo pogodbo o zaupnosti z avstralsko upravo za terapevtske proizvode (TGA), ki je četrta veljavna pogodba o zaupnosti.
Involvement in the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) continued in 2009, with efforts focusing on establishing the database of ENCePP research centres (made publicly available in December 2009, to be populated in 2010), establishing the ENCePP Steering Group, and drafting an ENCePP code of conduct and a checklist of methodological research standards (both of which were released for public consultation in November 2009). 
V letu 2009 se je nadaljevalo sodelovanje v Evropski mreži centrov za farmakoepidemiologijo in farmakovigilanco (ENCePP), pri čemer smo se trudili vzpostaviti zbirko podatkov raziskovalnih središč ENCePP (ki je bila javno objavljena decembra 2009 in se bo dopolnila v letu 2010), ustanoviti upravni odbor ENCePP in pripraviti osnutek kodeksa ravnanja in kontrolni seznam standardov metodološkega raziskovanja za ENCePP (oboje je bilo novembra leta 2009 dano na voljo za javno posvetovanje).
Looking to the future of medicines development, the Agency invites discussion on innovative therapeutic approaches and new development methods for human medicines. 
V pričakovanju razvoja zdravil agencija spodbuja razpravo o inovativnih terapevtskih pristopih ter novih metodah razvoja zdravil za uporabo v humani medicini.
Responding to increasing stakeholder expectations, the Agency launched a public-consultation process on a new transparency policy, bringing together in one comprehensive document the Agency's vision on its level of openness towards its stakeholders. 
Agencija je v odzivu na čedalje večja pričakovanja zainteresiranih strani sprožila postopek javne razprave o novi politiki preglednosti, tako da je v enem izčrpnem dokumentu združila vizijo agencije o odprtosti do zainteresiranih strani.
For one of these medicines, a tissue-engineered product containing chondrocytes, the CAT proposed a positive opinion to the Agency's Committee for Medicinal Products for Human Use (CHMP). 
Za eno od zdravil, zdravilo s hondrociti, pridobljeno s tkivnim inženirstvom, je CAT Odboru za zdravila za uporabo v humani medicini (CHMP) pri agenciji predlagal pozitivno mnenje.
Substantial increases were seen across many of the core areas relating to human medicines, including scientific advice, orphan designations, variations and safety-related activities. 
Bistveno več dela smo opazili na številnih glavnih področjih dejavnosti v zvezi z zdravili za uporabo v humani medicini, vključno z znanstvenim svetovanjem, dodelitvami statusov zdravil sirot, spremembami in dejavnostmi v zvezi z varnostjo.
Topics covered in 2009 included biomarkers and other novel development methods, nanotechnologies in life sciences and reinforced coordination between pharmaceuticals and devices authorities for the evaluation of targeted and combined medicinal products. 
V letu 2009 smo obravnavali biološke označevalce in druge nove metode razvoja, nanotehnologije v bioloških vedah ter okrepljeno usklajevanje med pristojnimi organi za farmacevtske izdelke in pripomočke pri presoji ciljnih in kombiniranih zdravil.
By the end of 2009, the Agency had received marketing-authorisation applications for three ATMPs. 
Do konca leta 2009 je agencija prejela vloge za pridobitev dovoljenja za promet s tremi zdravili za napredno zdravljenje.
The mobilisation of scientific experts from all over the EU made it possible to fast-track the scientific review of vaccines, so that by October 2009 three centrally authorised pandemic H1N1 vaccines were available for use by public-health authorities in the EU Member States. 
Aktiviranje strokovnjakov iz celotne EU je omogočila pospešitev strokovne presoje cepiv, tako da so bila oktobra leta 2009 za javnozdravstvene organe v državah članicah EU na voljo tri centralno odobrena cepiva proti pandemski gripi H1N1.
The Agency was immediately engaged in monitoring the situation following the initial outbreak, in April, and subsequently stepped up its activities as the WHO raised the pandemic level. 
Agencija je po prvotnem izbruhu aprila nemudoma začela spremljati razmere ter nato okrepila svoje dejavnosti, ko je SZO razglasila pandemijo.
EudraVigilance, the EU database and data-processing network for adverse drug reactions, was further developed in line with the project plan agreed by the EudraVigilance Steering Committee. 
Zbirko in mrežo za obdelavo podatkov o neželenih učinkih zdravil v EU EudraVigilance smo dodatno razvili v skladu z načrtom projekta, ki ga je pripravil upravni odbor EudraVigilance.
Updated product information in all EU languages, weekly pharmacovigilance reports and much other scientific and regulatory information was published in a dedicated section of the Agency's website. 
V posebnem razdelku na spletišču agencije so bile objavljene posodobljene informacije o cepivih v vseh jezikih EU, tedenska farmakovigilančna poročila ter veliko drugih znanstvenih in regulativnih podatkov.
For a genetherapy product, the CAT adopted a draft negative opinion. 
Za zdravilo na podlagi genske terapije je CAT sprejel osnutek negativnega mnenja.
The Agency developed a European strategy for benefit/risk monitoring of A/H1N1 influenza vaccines, in close collaboration with the European Centre for Disease Prevention and Control (ECDC) and the HMA. 
Agencija je v tesnem sodelovanju z Evropskim centrom za preprečevanje in obvladovanje bolezni (ECDC) ter HMA razvila evropsko strategijo spremljanja koristi in tveganj cepiv proti virusu gripe A/H1N1.
Core activities relating to medicines for human and veterinary use were conducted to a high level of quality, and regulatory timelines were consistently met. 
Osnovne dejavnosti, ki veljajo za zdravila za uporabo v humani in veterinarski medicini, so bile izvedene na zelo visoki kakovostni ravni, v zakonodaji določeni roki pa niso bili nikoli prekoračeni.
Promoting the availability of veterinary medicines, the Agency continued its contribution to the implementation of the action plan arising from the HMA Taskforce on Availability. 
Agencija je pri pospeševanju razpoložljivosti zdravil za uporabo v veterinarski medicini še naprej prispevala k izvajanju akcijskega načrta, ki ga je pripravila skupina za razpoložljivost pri HMA.
Pharmacovigilance of antivirals and vaccines used during the influenza pandemic was a major activity in 2009. 
V letu 2009 je bila poglavitna dejavnost farmakovigilanca protivirusnih zdravil in cepiv, ki so se uporabljala med pandemijo gripe.
The results achieved under intense pressure were due to the sustained commitment and cooperation of the national authorities of the Member States, the European Commission, the European Directorate for the Quality of Medicines and 
Rezultati, doseženi pod ogromnim pritiskom, so bili posledica vztrajne zaveze in sodelovanja nacionalnih organov držav članic, Evropske komisije, Evropskega direktorata za kakovost zdravil in zdravstvenega varstva, Evropskega centra za preprečevanje in obvladovanje bolezni, Evropske agencije za varnost hrane, Evropske agencije za zdravila ter seveda farmacevtske industrije.
Scientific-advice activities for human and veterinary medicines were significantly up, as were activities relating to the provision of support to small and medium-sized enterprises. 
Bistveno več je bilo strokovnega svetovanja za zdravila za uporabo v humani in veterinarski medicini, ravno tako je bilo več podpore malim in srednje velikim podjetjem.
For their outstanding dedication and hard work throughout what was one of the most active and challenging years in the history of the Agency, I am very grateful to all members of the Agency's scientific committees, working parties, staff and Management Board, whose efforts contributed greatly once again not only to the success of our organisation, but to the protection of public and animal health in Europe. 
Za izjemno predanost in trdo delo v letu, ki je bilo eno najdejavnejših in najtežjih v zgodovini Agencije, sem zelo hvaležen vsem članom znanstvenih odborov agencije in delovnih skupin ter osebju in upravnemu odboru.
The new identity was developed primarily to ensure that the communications materials of the Agency are created with a consistent look and feel, and to communicate to the public a clearer message about its role and activities. 
Agencija je 8. decembra 2009 predstavila svojo novo vizualno podobo, ki je bila razvita predvsem, da bi zagotovili dosleden videz in občutek v celotnem komunikacijskem gradivu agencije ter da bi javnosti posredovali jasnejše sporočilo o svoji vlogi in dejavnostih.
The CHMP took the unprecedented measure of reviewing these data on a rolling-review basis as and when they were received, rather than waiting for exhaustive data to become available. 
CHMP je prvič izvedel tekoče pregledovanje prihajajočih podatkov in ni čakal na predložitev obširnejših podatkov.
The Agency-led PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium) project was accepted for funding by the Innovative Medicines Initiative Joint Undertaking (IMI JU). 
Organizacija Innovative Medicines Initiative Joint Undertaking (IMI JU) je sklenila, da bo financirala projekt PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium - farmakoepidemiološko raziskavo izidov terapevtike, ki jo izvaja evropski konzorcij), ki ga vodi agencija.
Development of a new public website for the Agency - designed with the needs of the public in mind, offering improved navigation and search functionality, and better access to information on publichealth issues - was also a significant undertaking during the course of 2009. 
Pomembna naloga v letu 2009 je bil tudi razvoj novega javnega spletišča agencije, ki je bilo zasnovano glede na potrebe javnosti, sedaj pa ponuja boljšo navigacijo in iskanje ter boljši dostop do informacij o javnozdravstvenih vprašanjih.
The Agency had regular exchanges with regulators from Australia, Canada, Japan, the United States and experts from the World Health Organization (WHO). 
Zaradi pandemije gripe H1N1 se je raven dvo- in večstranskega mednarodnega sodelovanja povečala, ki še nikoli doslej..Agencija je večkrat gostila izmenjave med regulativnimi organi iz Avstralije, Kanade, Japonske in ZDA ter strokovnjake iz Svetovne zdravstvene organizacije (SZO).
Long-term effect 
Dolgoročni učinek
The reconstitution procedure usually takes a few minutes, but may take up to 15 minutes in some cases. 
Postopek rekonstitucije običajno traja nekaj minut, v nekaterih primerih pa tudi do 15 minut.
Key elements to be included in the educational material 
Ključni elementi, ki morajo biti vključeni v izobraževalnem gradivu
Results of the confirmatory Phase III study 
Rezultati potrditvene študije faze III
The muscle problems can be serious, 
Težave z mišicami so lahko resne,
This medicine is usually injected by a nurse or a doctor. 
To zdravilo navadno injicira medicinska sestra ali zdravnik.
Repeat the reconstitution procedure for the second dose. 
Ponovite postopek rekonstitucije za drugi odmerek.
The distribution volume in healthy elderly men is approximately 1 l/kg. 
Porazdelitveni prostor pri zdravih starejših moških je približno 1 l/kg.
This difference was statistically significant (p<0.001). 
Ta razlika je bila statistično signifikantna (p<0,001).
A very serious allergic reaction to this medicine is rare. 
Resna alergična reakcija na to zdravilo je redka.
These could be symptoms of a severe allergic reaction. 
To so lahko znaki hude alergijske reakcije.
Of the 610 patients treated 
Od 610 zdravljenih bolnikov jih je imelo
• Information on the identified and potential risks 
• informacije o znanih in možnih tveganjih.
This is due to the pharmacological effect; and the effect was reversible. 
To je posledica farmakološkega učinka; ta učinek je bil reverzibilen.
The first maintenance dose should be given one month after the starting dose. 
Prvi vzdrževalni odmerek moramo dati en mesec po začetnem odmerku.
Changes in laboratory parameters 
Spremembe laboratorijskih parametrov
<1/1,000) and very rare (<1/10,000). 
< 1/1.000) in zelo redki (< 1/10.000).
Hence, the procedure described below need to be repeated a second time. 
Zato je treba spodaj opisani postopek še enkrat ponoviti.
Therefore, all cardiovascular risk factors should be taken into account. 
Zato je potrebno upoštevati vse srčnožilne dejavnike tveganja.
Response Rate (confidence intervals)* * Kaplan Meier estimates within group 
Odzivnost (intervali zaupanja)* * Kaplan-Meierjeve ocene znotraj skupine
Plasma protein binding is estimated to be approximately 90%. 
Ocenjujejo, da je vezava na plazemske beljakovine približno 90-odstotna.
In the event of an overdose the patient should be monitored and appropriate supportive treatment should be given, if considered necessary. 
V primeru prevelikega odmerka je treba bolnika spremljati in mu po potrebi nuditi ustrezno podporno zdravljenje.
This medicine is stable for 2 hours at 25ºC. 
To zdravilo je stabilno 2 uri pri 25 ºC.
− Osteoporosis or any condition that affects the strenght of your bones. 
− osteoporozo ali katero drugo stanje, ki vpliva na trdnost vaših kosti.
Due to the risk of microbial contamination, this medicine should be used immediately. 
Zaradi tveganja mikrobiološke kontaminacije morate to zdravilo uporabiti takoj.
A ring of small air bubbles on the surface of the liquid is acceptable. 
Obroček majhnih zračnih mehurčkov na površini tekočine je sprejemljiv.
If blood appears in the syringe, the medicinal product can no longer be used. 
Če se v brizgi pojavi kri, zdravila ne smete več uporabiti.
In total 620 patients were randomised to one of the three treatment groups, of which 504 (81%) patients completed the study. 
Vsega skupaj 620 bolnikov so randomizirali v eno od treh zdravljenih skupin, od katerih je 504 (81 %) bolnikov dokončalo študijo.
Worsening or onset of diabetes may occur. 
Lahko pride do poslabšanja ali nastopa diabetesa.
The median age was 74 years (range 47 to 98 years). 
Mediana starost bolnikov je bila 74 let (meje med 47 in 98 leti).
Tabulated list of adverse reactions The frequency of undesirable effects listed below is defined using the following convention: 
Tabelarični seznam neželenih učinkov Pogostnost spodaj navedenih neželenih učinkov je opredeljena v skladu z naslednjim dogovorom:
These side effects may be due to the treatment or effects resulting from the underlying disease. 
Ta neželena učinka sta lahko posledica zdravljenja ali posledica osnovne bolezni.
The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following: 
Imetnik dovoljenja za promet z zdravilom (MAH) se mora z nacionalnimi pristojnimi organi dogovoriti o podrobnostih izobraževalnega programa in mora ta program uvesti nacionalno, s čimer bo zagotovil, da bodo pred začetkom predpisovanja vsi zdravniki prejeli paket z zdravstvenimi strokovnimi informacijami, ki bo vseboval:
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
Therefore in such patients, the benefit/risk ratio of FIRMAGON must be thoroughly appraised (see sections 4.5 and 4.8). 
Zato moramo pri takih bolnikih temeljito oceniti razmerje med koristjo in tveganjem, povezanim z uporabo zdravila FIRMAGON (glejte poglavji 4.5 in 4.8).
Choose a different injection site and inject 3 ml. 
Izberite drugo mesto injiciranja in injicirajte 3 ml.
In vitro studies have shown that degarelix is not a substrate for the human CYP450 system. 
Študije in vitro so pokazale, da degareliks ni substrat za humani sistem CYP450.
Intramuscular administration is not recommended as it has not been studied. 
Intramuskularna uporaba ni priporočljiva, ker je niso raziskovali.
Mannitol (E421), water for injections 
Manitol (E421), voda za injekcije.
If you have diabetes, you may have to measure blood glucose more frequently. 
Če imate sladkorno bolezen, si boste mogoče morali pogosteje meriti glukozo v krvi.
In healthy men, approximately 20-30% of a single intravenously administered dose is excreted in the urine, suggesting that 70-80% is excreted via the hepato-biliary system. 
Pri zdravih moških se približno 20-30 % posameznega intravensko danega odmerka izloči v urinu, kar kaže, da se 70-80 % zdravila izloča skozi hepatobiliarni sistem.
Discontinue the procedure and discard the syringe and the needle (reconstitute a new dose for the patient). 
Prekinite postopek in zavrzite brizgo in iglo (za bolnika rekonstituirajte nov odmerek).
If not used immediately, the use of this medicine are the responsibility of the user. 
Če se zdravilo ne uporabi takoj, je za uporabo tega zdravila odgovoren uporabnik.
What you need to know before you use FIRMAGON Do not use FIRMAGON 
Kaj morate vedeti, preden boste uporabili zdravilo FIRMAGON Ne uporabljajte zdravila FIRMAGON
What FIRMAGON is and what it is used for What you need to know before you use FIRMAGON How to use FIRMAGON 
Kaj je zdravilo FIRMAGON in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo FIRMAGON Kako uporabljati zdravilo FIRMAGON
If you forget to use FIRMAGON 
Če ste pozabili uporabiti zdravilo FIRMAGON
In case the patient's clinical response appears to be sub-optimal, it should be confirmed that serum testosterone levels are remaining sufficiently suppressed. 
Če se bolnikov klinični odziv zdi suboptimalen, moramo preveriti, ali serumske koncentracije testosterona ostajajo dovolj suprimirane.
Date of first authorisation: 17/02/2009 Date of latest renewal: 19/09/2013 
Datum pridobitve dovoljenja za promet: 17/02/2009 Datum zadnjega podaljšanja dovoljenja za promet: 19/09/2013
Reduced level of testosterone may cause a reduction in bone calcium (thinning of bones). 
Znižan nivo testosterona lahko povzroči znižanje kalcija v kosteh (tanjšanje kosti).
Preclinical studies on safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential revealed no special hazard for humans. 
Predklinične študije varnostne farmakologije, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in kancerogenega potenciala niso pokazale posebnega tveganja za človeka.
What FIRMAGON is and what it is used for 
Kaj je zdravilo FIRMAGON in za kaj ga uporabljamo
• Educational material 
• izobraževalno gradivo,
Do not use this medicine after the expiry date which is stated on the vials, syringes and outer packaging. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali, injekcijski brizgi in zunanji ovojnini.
It can be anticipated that long periods of testosterone suppression in men will have effects on bone density. 
Lahko predvidevamo, da bodo dolgotrajna obdobja testosteronske supresije pri moških vplivala na kostno gostoto.
Glucose tolerance 
Toleranca za glukozo
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to 
zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do
• 7% had an unknown metastatic status 
• 7 % neznano stanje glede metastaz,
• Summary of Product Characteristics (SPC) and Package Leaflet and Labelling 
• povzetek glavnih značilnosti zdravila (SPC), navodilo za uporabo in označevanje.
− febrile neutropenia (very low number of white blood cell in combination with fever), heart attack, heart failure 
− febrilna nevtropenija (zelo nizko število belih krvnih celic v kombinaciji z vročino), srčni napad, srčno popuščanje.
The injected liquid forms a gel from which degarelix is released over a period of one month. 
Iz vbrizgane tekočine nastane gel, iz katerega se degareliks sprosti v obdobju enega meseca.
The median PSA in the study at baseline was: 
Mediani PSA v študiji ob izhodišču je bil:
Effect on QT/QTc intervals 
Vpliv na interval QT/QTc
Side effects at the injection site are most common with the starting dose and less common with the maintenance dose. 
Neželeni učinki na mestu injiciranja so najbolj pogosti pri začetnem odmerku in manj pogosti pri vzdrževalnem odmerku.
− If you are allergic to degarelix or any of the other ingredients of this medicine (listed in section 6). 
− če ste alergični na degareliks ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
The efficacy and safety of degarelix was evaluated in an open-label, multi-centre, randomised, active comparator controlled, parallel-group study. 
Učinkovitost in varnost degareliksa so ovrednotili v odprti, multicentrični, randomizirani študiji s paralelnimi skupinami, kontrolirani z aktivnim primerjalnim zdravilom.
FIRMAGON must NOT be given into a blood vessel (intravenously). 
Zdravilo FIRMAGON se NE sme dati v krvno žilo (intravensko).
*Known physiological consequence of testosterone suppression 
*znana fiziološka posledica supresije testosterona
Powder Mannitol (E421) 
Prašek manitol (E421)
The reported events were mostly transient, of mild to moderate intensity and led to very few discontinuations (<1%). 
Dogodki, o katerih so poročali, so bili večinoma prehodni, blago do zmerno izraženi in so povzročili zelo malo prekinitev zdravljenja (<1 %).