natgillin/translations-raw huggingface dataset:
A special form of scientific advice, called protocol assistance, can be provided to help developers of orphan-designated medicines demonstrate that their medicine offers a significant benefit over other available treatments, which is a necessary condition for receiving a marketing authorisation for an orphan medicine. 
Izdelovalcem zdravil, ki so določena kot zdravila sirote, se lahko zagotovi posebna oblika znanstvenega svetovanja, ki ga imenujemo pomoč pri protokolu, za dokaz, da zdravilo kaže bistveno več koristi od drugih razpoložljivih načinov zdravljenja, kar je nujen pogoj za odobritev dovoljenja za promet z zdravilom siroto.
The Agency's total revenue in 2008 was 182,895,000 euro - slightly over 10% higher than in 2007. 
V letu 2008 so bili skupni prihodki Agencije 182 895 000 EUR - malo več kot za 10 % višji kot v letu V spodnji preglednici so razčlenjeni prihodki Agencije za leti 2007 in 2008 ter ocene za leto 2009.
released for public consultation 14 draft Community herbal monographs for traditional and wellestablished herbal medicines; 
v javno razpravo dal 14 osnutkov monografij rastlin Skupnosti za tradicionalna in dobro uveljavljena zdravila rastlinskega izvora;
a medicine for use in adults with long-term immune thrombocytopenic purpura, a rare disease in which the patient's immune system destroys the blood platelets that help blood to clot whenever the person bleeds. 
Zdravilo, ki se uporablja pri odraslih bolnikih z dolgotrajno imunsko trombocitopenično purpuro, redko boleznijo, pri kateri bolnikov imunski sistem uničuje trombocite, ki sodelujejo pri strjevanju krvi pri vsaki krvavitvi.
Applications relating to medicines for use against cancers, infectious diseases, metabolic diseases or alimentary-tract diseases were proportionally higher than ones relating to medicines for any other therapeutic use. 
Vlog, ki so se nanašale na zdravila proti raku, nalezljivim boleznim, presnovnim boleznim ali boleznim prebavil, je bilo več kot tistih za zdravila za drugačno terapevtsko rabo.
the first medicine for use as maintenance treatment in adults with acute myeloid leukaemia (a type of cancer affecting the white blood cells), in combination with interleukin-2 (an anticancer medicine). 
Prvo zdravilo za uporabo kot vzdrževalno zdravljenje pri odraslih z akutno mieloidno levkemijo (vrsto raka, ki prizadene levkocite) v kombinaciji z interlevkinom 2 (zdravilom proti raku).
In 2008, a total of 459,485 reports of adverse drug reactions (ADRs) associated with the use of medicines in humans were entered into EudraVigilance. 
V letu 2008 je bilo v sistem EudraVigilance vnesenih skupno 459 485 poročil o neželenih učinkih zdravil, ki so bili povezani z uporabo zdravil pri ljudeh.
Assessment work in relation to paediatric medicines, rare-disease medicines, herbal medicines and veterinary medicines was intensive in 2008 too, while the volume of work in relation to the provision of scientific advice, the drafting of guidelines, the processing of variation applications and the conduct of pharmacovigilance activities was reasonably high overall. 
V letu 2008 je intenzivno potekalo tudi ocenjevanje zdravil za otroke in redke bolezni, zdravil rastlinskega izvora in veterinarskih zdravil, precej dela pa je bilo tudi s podajanjem znanstvenih mnenj, pripravo smernic, obdelavo vlog za spremembe dovoljenj za promet in farmakovigilančnimi dejavnostmi.
a medicine to treat hyperphenylalaninaemia (high levels of phenylalanine in the blood) in patients with the genetic disorders phenylketonuria or tetrahydrobiopterin deficiency. 
Zdravilo za zdravljenje hiperfenilalaninemije (visokih ravni fenilalanina v krvi) pri bolnikih z gensko boleznijo fenilketonurijo ali pomanjkljivostjo tetrahidrobiopterina.
Establishing scientific opinions on herbal medicines 
Izdaja znanstvenih mnenj o zdravilih rastlinskega izvora
7 related to medicines for the treatment of a variety of conditions in dogs, including pain, tumours and musculo-skeletal disorders; 
7 mnenj za zdravila za zdravljenje različnih bolezni pri psih, vključno z bolečinami, tumorji in boleznimi mišic in kosti;
This project will include consultation with the Agency's primary audiences, including patients, healthcare professionals, regulatory authorities and pharmaceutical companies, and is scheduled to deliver a new website by the end of 2009. 
Ta projekt bo vključeval posvetovanje s primarnim občinstvom Agencije, vključno z bolniki, zdravstvenimi strokovnjaki, regulativnimi organi in farmacevtskimi družbami.
an anti-rheumatic biological agent (interleukin-6 receptor antagonist) that can be used in combination with methotrexate to treat adults with moderate to severe active rheumatoid arthritis (an immune disease causing inflammation of the joints). 
Protirevmatsko biološko zdravilo (antagonist receptorja interlevkina 6), ki se uporablja v kombinaciji z metotreksatom za zdravljenje odraslih bolnikov z zmernim do resnim aktivnim revmatoidnim artritisom (imunsko boleznijo, ki povzroča vnetje sklepov).
Initial-evaluation procedures relate to applications for new medicines that have not previously been authorised in the European Union. 
Postopki za začetno oceno se nanašajo na vloge za odobritev novih zdravil, ki prej niso bila odobrena v Evropski uniji.
a medicine to treat high-grade, non-metastatic osteosarcoma (a rare bone cancer) in children, adolescents and young adults. 
Zdravilo za zdravljenje osteosarkoma (redkega kostnega raka) z visoko stopnjo in brez zasevkov pri otrocih, mladostnikih in mladih odraslih.
1 related to a vaccine for the prevention of West Nile Virus in horses and ponies; 1 related to a medicine to combat porcine circovirus in pigs; 
1 mnenje za cepivo za preprečevanje okužbe z zahodnonilskim virusom pri konjih in ponijih; 1 mnenje za zdravilo proti cirkovirusu pri prašičih;
Positive opinions Applications withdrawn prior to opinion Negative opinions 
Pozitivna mnenjaVloge, umaknjene pred mnenjem Negativna mnenja
Type-I variations relate to minor changes to the marketing authorisation for a medicine, such as a change in the name of the medicine, change of the marketing-authorisation holder's or manufacturer's name or address, minor changes to the components of the medicine or their manufacturing processes, or minor changes to the packaging materials. 
Spremembe tipa I se nanašajo na manjše spremembe dovoljenja za promet z zdravilom, kot so sprememba imena zdravila, sprememba imetnika dovoljenja za promet ali imena oz. naslova izdelovalca, manjše spremembe sestavin zdravila ali njihovega proizvodnega postopka ali manjše spremembe materialov ovojnine.
two medicines used to prevent the formation of venous thromboembolism (blood clots in the veins), which can be administered orally and therefore provide an alternative to conventional therapy by injection. 
Dve zdravili za preprečevanje nastanka venske tromboembolije (krvnih strdkov v venah), ki se dajeta peroralno in sta zato alternativi običajnemu zdravljenju z injiciranjem.
In 2008, the Agency's Committee for Medicinal Products for Human Use (CHMP) adopted 66 positive opinions1 - the highest number ever adopted in a single year - following its completion of initialevaluation procedures2 for new medicines for human use. 
V letu 2008 je Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji po zaključku postopkov za začetno oceno1 novih zdravil za uporabo v humani medicini sprejel 66 pozitivnih mnenj2
Number of initial-evaluation applications received for veterinary medicines remains stable 
Število vlog za začetno oceno zdravil za uporabo v veterinarski medicini ostaja stabilno
Besides monitoring adverse-reaction reports, the Agency also reviews periodic safety update reports that marketing-authorisations holders are obliged to submit in respect of their centrally authorised medicines. 
Agencija poleg spremljanja poročil o neželenih učinkih pregleduje tudi periodična poročila o varnosti zdravila, ki jih morajo imetniki dovoljenj za promet z zdravilom predlagati v zvezi z zdravili, za katera
a medicine for the treatment of adults who cannot have a bone-marrow transplant and suffer from myelodysplastic syndromes (conditions where the bone marrow produces too few blood cells). 
Zdravilo za zdravljenje odraslih bolnikov, katerim ni možno presaditi kostnega mozga in imajo mielodisplastične sindrome (bolezni, pri katerih v kostnem mozgu nastaja premalo krvnih celic).
Initial-evaluation applications received, by type of application 
Prejete vloge za začetno oceno, po vrsti vloge
A total of 104 applications for post-authorisation evaluation of veterinary medicines were received in 2008 - just slightly fewer than the 109 received in 2007. 
V letu 2008 smo prejeli skupno 104 vloge za oceno zdravil za uporabo v veterinarski medicini po izdaji dovoljenja za promet - nekoliko manj kot v letu 2007, ko je bilo prejetih 109 vlog.
A total of 2,246 applications relating to post-authorisation activities concerning medicines for human use were received in 2008 - a 10% increase on the number received in the previous year. 
V letu 2008 smo prejeli skupno 2 246 vlog za dejavnosti po izdaji dovoljenja za promet za zdravila za uporabo v humani medicini - 10 % več kot v predhodnem letu.
preparing and releasing for consultation a policy on access to documents, which foresees the ability for the public to request access to any document produced or received and held by the Agency; 
Politika predvideva možnost, da javnost zahteva dostop do katerega koli dokumenta, ki nastane v Agenciji ali ga Agencija prejme in hrani;
The number of positive opinions adopted on marketing-authorisation applications for medicines for human use was higher than in any year to date. 
V tem letu je bilo število pozitivnih mnenj o vlogah za odobritev dovoljenja za promet z zdravilom za uporabo v humani medicini največje doslej.
Type-II variations relate to major changes to the marketing authorisation for a medicine, such as a change in the medicine's indication (the type of disease or condition it can be used to treat), or a substantial change to the packaging or to the information that accompanies the medicine. 
Spremembe tipa II se nanašajo na večje spremembe dovoljenja za promet z zdravilom, kot so sprememba indikacije zdravila (vrste bolezni ali stanja, za katerega se lahko uporablja), bistvena sprememba ovojnine ali informacij, ki so priložene zdravilu.
Alternatively, if their medicine is not intended for paediatric use, they must apply for a waiver from the obligation to submit a PIP. 
Kadar zdravilo ni namenjeno za uporabo v pediatriji, pa mora družba zaprositi za opustitev obveznosti predložitve načrta pediatričnih raziskav.
Orphan medicinal product designation procedures (2006-2008) 
Postopki za določitev zdravila sirote (2006-2008)
Line-extension applications relate to changes to the active substance(s), strength, pharmaceutical form (e.g. powder, ointment or tablet) or route of administration (e.g. oral, intravenous or subcutaneous) of an authorised medicine. 
Vloge za razširitev se nanašajo na spremembe zdravilne učinkovine (zdravilnih učinkovin), jakosti, farmacevtske oblike (npr. prašek, mazilo ali tablete) ali poti uporabe zdravila (npr. peroralno, intravensko ali podkožno) za odobreno zdravilo.
1 related to a medicine for the treatment of bovine mastitis in bovines. 
1 mnenje za zdravilo za zdravljenje mastitisa pri govedu.
1 related to a painkiller for use in dogs and cats; 
1 mnenje za zdravilo proti bolečinam za uporabo pri psih in mačkah;
Volume of post-authorisation procedures initiated for veterinary medicines remains stable 
Delež postopkov po izdaji dovoljenja za promet, sproženih za zdravila za uporabo v veterinarski medicini, ostaja stabilen
Positive opinions Negative opinions Application withdrawals 
Pozitivna mnenja Negativna mnenja Umiki
Applications for approval of PIPs, waivers and PUMAs are assessed by the Agency's Paediatric Committee, which also conducts compliance-checks to verify that companies applying for a marketing authorisation have developed their medicine in accordance with their approved PIP. 
Vloge za odobritev načrta pediatričnih raziskav, opustitev in dovoljenja za promet z zdravili za uporabo v pediatriji vrednoti Odbor za pediatrijo pri Agenciji, ki tudi preverja, ali je družba, ki je predložila vlogo za odobritev, zdravilo razvila skladno z odobrenim načrtom pediatričnih raziskav.
Outcome of initial-evaluation applications (2006-2008) 
Izidi vlog za začetno oceno (2006-2008)
1 related to a painkiller/anti-inflammatory for use in horses; 
1 mnenje za zdravilo proti bolečinam/vnetju za uporabo pri konjih;
Volume of post-authorisation procedures finalised for human medicines increased by 13% 
Delež postopkov po izdaji dovoljenja za promet, zaključenih za zdravila za uporabo v humani medicini, se je povečal za 13 %
Number of initial-evaluation applications for human medicines up by 14% 
Za 14 % več vlog za začetno oceno zdravil za uporabo v humani medicini
Fees 
Ciper
New medicinal products (non-orphan) Orphan medicinal products Similar biological products 
Nova zdravila (brez sirot)
The volume of applications received by the Agency in 2008 for initial evaluation of new veterinary medicines was, at 16 applications, similar to the volume seen in 2007. 
Agenciji je bilo v letu 2008 predloženih 16 vlog za začetno oceno novih zdravil za uporabo v veterinarski medicini, kar je podobno številu prejetih vlog v letu 2007.
1 related to a medicine for the treatment of respiratory disease in cattle; 
1 mnenje za zdravilo za zdravljenje bolezni dihal pri govedu;
The number of initial-evaluation applications submitted to the Agency in 2008 for evaluation of new medicines for use in humans was 103 - a 14% increase on the number received in 2007. 
Agenciji so bile v letu 2008 predložene 103 vloge za začetno oceno novih zdravil za uporabo v humani medicini, kar predstavlja 14-odstotno zvišanje glede na število prejetih vlog v letu 2007.
Volume of post-authorisation procedures initiated for human medicines increased by 10% 
Delež postopkov po izdaji dovoljenja za promet, sproženih za zdravila za uporabo v humani medicini, se je povečal za 10 %
Type-I variations Type-II variations Extensions 
Spremembe tipa I Spremembe tipa II
finalised a record number of 328 scientific-advice and protocol-assistance requests relating to medicines for human use (up 14% on the number of requests finalised in 2007); 
zaključila rekordno število 328 zahtevkov za znanstveno svetovanje in pomoč pri protokolu v zvezi z zdravili za uporabo v humani medicini (za 14 % več kot je bilo zaključenih zahtevkov v letu prejela 320 novih ali naknadnih zahtevkov za znanstveno svetovanje ali pomoč pri protokolu v zvezi z zdravili za uporabo v humani medicini;
5 The ‘Community list…' is an official list, established by the HMPC and approved by the European Commission, of herbal substances and preparations that have been in medicinal use for a sufficiently long time, and which are therefore considered not to be harmful under normal conditions of use. 
Vsebuje rastlinske snovi in pripravke, ki so bili v medicinski rabi dovolj dolgo in štejejo kot neškodljivi v običajnih pogojih uporabe.
Applications for new medicinal products Generic applications 
Vloge za generična zdravila
adopted 35 decisions on class waivers3; 
(Klinične) spremembe tipa II Razširitve sprejel 35 odločitev o skupinskih opustitvah3;
The next few pages provide brief highlights of the Agency's activities in each of its priority areas for the year, together with key figures to demonstrate the volume and evolution of its core scientific and regulatory procedures. 
Dodane so ključne številke za prikaz obsega in razvoja njenih osrednjih strokovnih in regulativnih postopkov.
Type-IA variations 
Spremembe tipa IA
The number of initial-evaluation procedures finalised by the Agency in relation to veterinary medicines in 2008 was 13. 
V letu 2008 je Agencija dokončala 13 postopkov za začetno oceno zdravil za uporabo v veterinarski medicini.
EEA and non-EEA ADR reports received (2006-2008) 
Prejeta poročila o neželenih učinkih zdravil iz EGP in izven EGP (2006-2008)
launch of the ENCePP website11, devoted to the activities of the newly created European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), which is coordinated by the Agency; creation of a new ‘Regulatory and procedural guidelines' section12 of the Agency's public website, 
Do takrat pa se je komunikacija Agencije prek spleta med letom stalno izboljševala, vključno z: zagonom spletne strani ENCePP11, namenjene dejavnostim novo ustanovljene Evropske mreže centrov za farmakoepidemiologijo in farmakovigilanco, ki jo usklajuje Agencija;
Efforts made in 2008 to further enhance the involvement of healthcare professionals, patients and consumers in the Agency's activities included: extending the scope of patients' and consumers' involvement in reviewing the quality of package leaflets (the information contained in the package of a medicine); working with patients and consumers to establish, by means of a survey, their level of satisfaction with their current involvement in the activities of the Agency; integrating input received from healthcare professionals, patients and consumers in the development of the Agency's communications strategy. 
delo z bolniki in potrošniki, da bi z anketo ugotovili zadovoljstvo s trenutnim sodelovanjem pri dejavnostih Agencije;
Post-authorisation applications received (2006-2008) 
Prejete vloge za postopke po izdaji dovoljenja za promet (2006-2008)
4 A herbal monograph is a collection of all relevant information concerning a herbal medicine, including its composition, use, safety precautions, etc. 
Monografija rastlin je zbirka vseh pomembnih informacij o zdravilu rastlinskega izvora, vključno z njegovo sestavo, uporabo, varnostnih ukrepih itn. „Seznam rastlinskih snovi Skupnosti …“ je uradni seznam, ki ga uveljavil HMPC, odobrila pa Evropska komisija.
Applicants are exempt from the obligation to submit a product-specific waiver application if the medicine for which they are seeking a marketing authorisation belongs to one of these classes. 
Če zdravilo, za katerega vlagatelji želijo odobritev, spada v eno izmed teh skupin, ni treba predložiti vloge za opustitev, specifične za zdravilo.
The Agency is committed to maintaining a strong working relationship with these important stakeholders, and has created a number of mechanisms for their involvement in a range of its activities, including: participating in meetings of the Patients' and Consumers' Working Party or of the Healthcare Professionals' Working Group; checking the quality of information about authorised medicines; assisting in the preparation of regulatory and procedural guidance documents; providing recommendations to the Agency and its scientific committees on all matters of direct or indirect interest to them. 
Agencija se je zavezala k ohranjanju trdnega delovnega odnosa s temi pomembnimi interesnimi skupinami je ustvarila številne mehanizme za njihovo vključitev v vrsto svojih dejavnosti, vključno s:
13 related to ‘orphan' medicines, i.e. ones intended for use in the diagnosis, prevention or treatment of rare and seriously debilitating diseases or conditions; 
Izmed 103 vlog, prejetih v letu 2008: se jih je 73 nanašalo na zdravila z novo zdravilno učinkovino, tj. kemijsko ali biološko spojino, ki se prej ni uporabila v odobrenem zdravilu; se jih je 13 nanašalo na zdravila „sirote“, tj. zdravila, ki so namenjena uporabi pri diagnostiki, preprečevanju ali zdravljenju redkih in resno izčrpavajočih bolezni ali stanj; se jih je 46 nanašalo na generična ali hibridna zdravila, tj. zdravila, katerih zdravilna učinkovina je v bistvu enaka kot pri prej odobrenem zdravilu; so se 3 nanašale na „podobna biološka zdravila“, tj. zdravila, katerih zdravilno učinkovino izdeluje živ organizem ali je pridobljena iz njega ter je podobna zdravilni učinkovini prej odobrenega zdravila.
If this happens, try again. 
Če se to zgodi, poskusite znova.
1.0 unit 
1,0 enota
Throw away the bag. 
Vrečko zavrzite.
Percentage of Patients who achieved MCID 
Odstotek bolnikov, ki so dosegli MCID
Date of first authorisation: 20 July 2012 Date of last renewal: 20 April 2017 
Datum prve odobritve: 20. julij 2012 Datum zadnjega podaljšanja: 20. april 2017
A risk to newborns/infants cannot be excluded. 
Tveganja za novorojenčke/dojenčke ni možno izključiti.
Some patients may not hear the ‘click'. 
Nekateri bolniki morda ne bodo slišali zvoka ‘klik'.
Deterioration of disease: 
Poslabšanje bolezni:
It will also help you to remember to use it. 
Prav tako vam bo pomagalo, da se spomnite uporabiti zdravilo.
The upper bound of the confidence interval excluded a pre-defined risk margin of 1.8. 
Zgornja meja intervala zaupanja je izključevala vnaprej določeno mejo tveganja 1,8.
Therefore, please remember to pay attention to oral hygiene. 
Zaradi tega morate biti pozorni na ustno higieno.
This ensures that there is always enough medicine in your body to help you breathe more easily throughout the day and night. 
S tem zagotovite vedno dovolj zdravila v svojem telesu, kar vam pomaga, da cel dan in noč lažje dihate.
What should you do if you accidently prepare a dose? 
Kaj storiti, če po nesreči pripravite odmerek?
If you want to stop treatment, first talk to your doctor, as your symptoms may worsen. 
Če želite zdravljenje prekiniti, se najprej pogovorite z zdravnikom, ker se lahko simptomi poslabšajo.
Allergic reactions may rarely occur (may affect up to 1 in 1,000 people). 
Redko lahko pride do alergijskih reakcij (pojavijo se lahko pri največ 1 od 1.000 bolnikov).
How does the dose indicator work? 
Kako deluje indikator odmerka?
70.7% of patients completed the study per investigator assessment. 
Po raziskovalčevi oceni je študijo dokončalo 70,7 % bolnikov.
Make sure the green button is on top. 
Prepričajte se, da je zeleni gumb na vrhu.
2.5 Hold your breath for as long as possible. 
2.5 Zadržujte dih kolikor dolgo je mogoče.
How do you know that your inhaler is empty? 
Kako veste, da je inhalator prazen?
The study had an event-driven design and was terminated once sufficient MACE events for the primary safety analysis were observed. 
Študija je imela z dogodki voden načrt in se je končala, ko je bilo opaženih dovolj dogodkov MACE za primarno analizo varnosti.
Paradoxical bronchospasm: 
Paradoksni bronhospazem:
• On first use, every inhaler contains at least 60 doses, or at least 30 doses, depending on the pack size. 
• Ob prvi uporabi vsak inhalator vsebuje najmanj 60 odmerkov ali najmanj 30 odmerkov, odvisno od velikosti pakiranja.
If the control window still does not change to red, you may have forgotten to release the green button before inhaling, or you may not have inhaled strongly enough. 
Če se kontrolno okence še vedno ne obarva rdeče, ste morda pred inhaliranjem pozabili sprostiti zeleni gumb, ali pa morda niste dovolj močno inhalirali.
For Instructions for Use, see section 6.6. 
Za navodila za uporabo, glejte poglavje 6.6.
The recommended dose is one inhalation twice a day in the morning and evening. 
Priporočeni odmerek je en vdih dvakrat na dan zjutraj in zvečer.
Control window Red = confirms correct inhalation 
Kontrolno okence Rdeča = potrdi pravilno inhalacijo
30 doses 60 doses 
30 odmerkov 60 odmerkov
All patients had a history of cardiovascular or cerebrovascular disease and/or significant cardiovascular risk factors. 
Vsi bolniki so imeli v anamnezi srčno-žilno ali cerebrovaskularno bolezen in/ali pomembne srčno-žilne dejavnike tveganja.
When you press the button all the way down, the control window changes from red to green. 
Ko pritisnite gumb do konca, se kontrolno okence spremeni iz rdečega v zelenega.
The rate of moderate or severe COPD exacerbations per patient per year during the first year of treatment was evaluated as the primary efficacy endpoint in the study. 
Delež zmernih ali hudih poslabšanj KOPB na bolnika na leto v prvem letu zdravljenja so ovrednotili kot primarni opazovani dogodek učinkovitosti v študiji.
Never breathe out into the inhaler (Figure I). 
Nikoli ne izdihnite v inhalator (Slika I).
NEVER use water to clean the inhaler, as this may damage your medicine. 
NIKOLI ne uporabljajte vode za čiščenje inhalatorja, ker lahko poškodujete zdravilo.