natgillin/translations-raw huggingface dataset:
Further information on Pelgraz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije za zdravilo Pelgraz so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Pain in muscles is also common. 
Pogosta je tudi bolečina v mišicah.
What measures are being taken to ensure the safe and effective use of Pelgraz? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pelgraz?
This means that Pelgraz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU. 
To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
The most common side effect with Pelgraz (which may affect more than 1 in 10 people) is pain in the bones. 
Najpogostejši neželeni učinek zdravila Pelgraz (ki se lahko pojavi pri več kot 1 od 10 bolnikov) je bolečina v kosteh.
Side effects reported with Pelgraz are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Pelgraz, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Pelgraz is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines). 
Zdravilo Pelgraz se daje v obliki enkratnega odmerka 6 mg, ki se injicira pod kožo vsaj 24 ur po koncu vsakega cikla kemoterapije (zdravljenja z zdravili proti raku).
An overview of Pelgraz and why it is authorised in the EU 
Pregled zdravila Pelgraz in zakaj je odobreno v EU
Why is Pelgraz authorised in the EU? 
Zakaj je bilo zdravilo Pelgraz odobreno v EU?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pelgraz have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Pelgraz upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
As for all medicines, data on the use of Pelgraz are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Pelgraz stalno spremljajo.
For more information about using Pelgraz, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Pelgraz glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Pelgraz can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders. 
Predpisovanje in izdaja zdravila Pelgraz je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka ali krvnih bolezni.
The reference medicine for Pelgraz is Neulasta. 
Referenčno zdravilo za zdravilo Pelgraz je zdravilo Neulasta.
What benefits of Pelgraz have been shown in studies? 
Kakšne koristi zdravila Pelgraz so se pokazale v študijah?
What is Pelgraz and what is it used for? 
Kaj je zdravilo Pelgraz in za kaj se uporablja?
Other information about Pelgraz 
Druge informacije o zdravilu Pelgraz
What are the risks associated with Pelgraz? 
Kakšna tveganja so povezana z zdravilom Pelgraz?
All these data were considered sufficient to conclude that Pelgraz will behave in the same way as Neulasta in terms of effectiveness and safety in its approved uses. 
Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Pelgraz pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Neulasta.
The active substance in Pelgraz, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF). 
Učinkovina zdravila Pelgraz, pegfilgrastim, je sestavljena iz filgrastima, ki je zelo podoben človeški beljakovini, imenovani granulocitne kolonije spodbujajoči faktor (G-CSF).
Because Pelgraz is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Pelgraz. 
Zdravilo Pelgraz je podobno biološko zdravilo, zato študij o učinkovitosti in varnosti pegfilgrastima, izvedenih z zdravilom Neulasta, z zdravilom Pelgraz ni treba ponavljati.
In addition, a study involving 589 patients who had chemotherapy after surgery for breast cancer showed that Pelgraz was as effective as Neulasta in reducing the duration of neutropenia. 
Poleg tega so v študiji, ki je vključevala 589 bolnic, ki so se po kirurškem posegu zaradi raka dojk zdravile s kemoterapijo, dokazali, da je zdravilo Pelgraz pri skrajševanju trajanja nevtropenije enako učinkovito kot zdravilo Neulasta.
For the full list of side effects and restrictions with Pelgraz, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Pelgraz glejte navodilo za uporabo.
Pelgraz is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, , which can develop into leukaemia). 
Zdravilo Pelgraz ni namenjeno uporabi pri bolnikih s krvnim rakom, tj. kronično mieloično levkemijo ali mielodisplastičnimi sindromi (boleznimi, pri katerih nastajajo velike količine nenormalnih krvnih celic, ki se lahko razvijejo v levkemijo).
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Pelgraz has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Pelgraz po zgradbi, čistosti in biološkem delovanju primerljivo zdravilu Neulasta in da se po telesu enako prenaša.
Therefore, the Agency's view was that, as for Neulasta, the benefit of Pelgraz outweighs the identified risk and it can be authorised for use in the EU. 
Agencija je menila, da koristi zdravila Pelgraz, enako kot pri zdravilu Neulasta, odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
In addition, a study in breast cancer patients undergoing chemotherapy has shown that the effectiveness of Pelgraz is equivalent to that of Neulasta in reducing the duration of neutropenia. 
Poleg tega so v študiji pri bolnicah z rakom dojke, ki so se zdravile s kemoterapijo, dokazali, da je učinkovitost zdravila Pelgraz pri skrajševanju trajanja nevtropenije enakovredna učinkovitosti zdravila Neulasta.
Pelgraz is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections. 
Zdravilo Pelgraz se uporablja pri bolnikih z rakom za pomoč pri nevtropeniji (zmanjšanem številu nevtrofilcev, vrste belih krvnih celic), ki je pogost neželeni učinek pri zdravljenju raka, zaradi katerega pa so bolniki dovzetnejši za okužbe.
Pelgraz is a ‘biosimilar medicine'. 
Zdravilo Pelgraz je „podobno biološko zdravilo“.
Studies have also shown that giving Pelgraz produces similar levels of the active substance in the body to giving Neulasta. 
Študije so pokazale tudi, da zdravilo Pelgraz vzpostavi podobne ravni učinkovine v telesu kot zdravilo Neulasta.
How does Pelgraz work? 
Kako zdravilo Pelgraz deluje?
How is Pelgraz used? 
Kako se zdravilo Pelgraz uporablja?
Laboratory studies comparing Pelgraz with Neulasta have shown that the active substance in Pelgraz is highly similar to that in Neulasta in terms of structure, purity and biological activity. 
Laboratorijske študije, v katerih so zdravilo Pelgraz primerjali z zdravilom Neulasta, so pokazale, da je učinkovina zdravila Pelgraz po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Neulasta.
In Pelgraz, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol). 
V zdravilu Pelgraz je filgrastim pegiliran (vezan na snov, imenovano polietilenglikol).
This summary was last updated on 11.01.2007. 
Ta povzetek je bil nazadnje posodobljen 11.01.2007.
All these effects disappear after a while without specific treatment. 
Vsi ti učinki po določenem času izzvenijo brez posebnega zdravljenja.
Wash hands after administration. 
Po dajanju si umijte roke.
Its effect can be seen within about 2 weeks, and lasts for 5 months. 
Njegov učinek je mogoče opaziti v 2 tednih, traja pa 5 mesecev.
After this time, the dog should be re-examined by a veterinarian and treatment might be repeated. 
Po tem času mora psa ponovno pregledati veterinar in zdravljenje je mogoče ponoviti.
The medicine is available as 1.875 mg, 3.75 mg, 7.5 mg or 15 mg tablets, which can be used for dogs of different weights (small, medium sized, large or very large dogs). 
Zdravilo je na voljo kot 1,875 mg, 3,75 mg, 7,5 mg ali 15 mg tablete, ki se lahko uporabljajo za pse različne mase (majhne, srednje velike, velike ali zelo velike pse).
A clinical response to treatment (reduction of prostate volume) was seen within 14 days, which lasted for at least 5 months. 
Klinični odgovor na zdravljenje (zmanjšanje prostornine prostate) je bil opažen v 14 dneh, trajal pa je najmanj 5 mesecev.
The most common side effects are a transient increase in appetite, and changes in the behaviour of the dog (changes in activity levels, more sociable behaviour). 
Najpogostejši neželeni stranski učinki so prehodno povečanje apetita ter spremembe v vedenju psa (sprememba v ravni aktivnosti, bolj družabno vedenje).
Ypozane is given daily for 7 days. 
Zdravilo Ypozane se daje dnevno v obdobju 7 dni.
The European Commission granted a marketing authorisation valid throughout the European Union, for Ypozane to Virbac S.A. on 11.01.2007. 
Evropska komisija je dovoljenje za promet z zdravilom Ypozane, veljavno po vsej Evropski uniji, odobrila družbi Virbac S.A. dne 11.01.2007.
This veterinary medicine has been developed especially for dogs and is not for use in humans. 
To veterinarsko zdravilo je bilo razvito posebej za pse in ni namenjeno za uporabo pri ljudeh.
The effectiveness of osaterone acetate was investigated in a large study undertaken in a number of veterinary practices across Europe. 
Učinkovitost osateronijevega acetata so preučevali v okviru velike raziskave, v kateri so sodelovale številne veterinarske ambulante po celi Evropi.
Some dogs might also show vomiting, diarrhoea or increased thirst, or might develop a “feminisation syndrome”. 
Pri nekaterih psih lahko pride tudi do bruhanja, driske ali povečane žeje oziroma utegnejo razviti »sindrom feminizacije«.
Ypozane has no adverse effects on semen quality. 
Zdravilo Ypozane nima negativnih vplivov na kakovost semena.
The dogs received once a day for 7 days, one Ypozane tablet appropriate for their size to correspond to a daily dose of 0.250.5 mg osaterone acetate per kilogram bodyweight. 
Psi so enkrat dnevno v obdobju 7 dni prejemali eno tableto zdravila Ypozane take velikosti, da je dnevni odmerek znašal 0,250,5 mg osateronijevega acetata na kilogram telesne mase.
In female laboratory animals, osaterone acetate caused serious adverse effects on reproductive functions. 
Pri laboratorijskih živalih ženskega spola je imel osateronijev acetat resne neželene učinke na razmnoževalne funkcije.
This is when male dogs suddenly become attractive to other male dogs or the size of their mammary glands increases. 
O njem govorimo, če postanejo psi samci nenadoma privlačni za druge pse samce ali če se poveča velikost njihovih mlečnih žlez.
When it is enlarged, it can lead to abdominal pain, constipation and difficulties in urinating in the dogs affected. 
Če je povečana, utegne povzročiti bolečino v trebuhu, zaprtje in težave pri uriniranju pri prizadetih psih.
Dogs with enlarged prostates from various breeds, age groups and weights, were either treated with Ypozane or with another product, which is already authorised in the EU for this indication. 
Psi s povečano prostato različnih pasem, starostnih skupin in mase so bili zdravljeni bodisi z zdravilom Ypozane bodisi z drugim zdravilom, ki je že odobren v EU za to indikacijo.
The prostate is a gland that produces a fluid that is part of the semen. 
Prostata je žleza, ki tvori tekočino, ki je sestavina semena.
Osaterone acetate is a hormone that is chemically related to progesterone, and as such it has anti-androgen and progestagen activity. 
Osateronijev acetat je hormon, ki je kemično soroden s progesteronom in ima kot tak protiandrogeno in progestagensko delovanje.
Therefore, women of child-bearing age should avoid contact with, or wear disposable gloves, when handling the tablets. 
Ženske v plodni dobi naj se zato izogibajo stiku z njim oziroma pri rokovanju s tabletami nosijo rokavice za enkratno uporabo.
In male dogs, it blocks the transport of the male hormone testosterone into the prostate. 
Pri psih samcih zavira prenos moškega hormona testosterona v prostato.
What benefit has Ypozane shown during the studies? 
Kakšne koristi je zdravilo Ypozane izkazalo med raziskavami?
What is the risk associated with Ypozane? 
Kakšna tveganja so povezana z zdravilom Ypozane?
Data were provided on the pharmaceutical quality of the product, the tolerance of Ypozane in dogs and the safety of the tablets when handled by humans. 
Predloženi so bili podatki o farmacevtski kakovosti izdelka, kako psi zdravilo Ypozane prenašajo ter o varnosti tablet za ljudi, ki rokujejo z njimi.
The benefitrisk balance may be found in module 6 of this EPAR. 
Razmerje med koristmi in tveganji najdete v modulu 6 tega Evropskega javnega poročila o oceni zdravila (EPAR).
If a person accidentally takes the medicine, seek medical advice immediately and show the package leaflet or the label to a doctor. 
V primeru nenamerne uporabe zdravila pri ljudeh je treba nemudoma poiskati medicinsko pomoč in pokazati zdravniku Navodila za uporabo ali nalepko.
Ypozane should be used with caution in dogs which have had liver problems. 
Zdravilo Ypozane je treba pri psih, ki so imeli težave z jetri, uporabljati previdno.
Ypozane is used in male dogs for the treatment of “benign prostatic hypertrophy”, which means an increase of the size of the prostate gland that is not related to cancer (benign). 
Zdravilo Ypozane se uporablja pri psih samcih za zdravljenje »benigne hipertrofije prostate«, kar pomeni povečanje velikosti prostate, ki ni povezano z rakom (benigno).
By inhibiting testosterone, Ypozane helps the prostate to shrink back to its normal size. 
Z zaviranjem testosterona zdravilo prispeva h krčenju prostate na njeno normalno velikost.
Other information about Ypozane: 
Druge informacije o zdravilu Ypozane:
Why has Ypozane been approved? 
Zakaj je bilo zdravilo Ypozane odobreno?
Treatment with Ypozane was effective in the treatment of benign prostatic hypertrophy. 
Zdravljenje z zdravilom Ypozane je bilo pri zdravljenju benigne hipertrofije prostate učinkovito.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ypozane exceed its risks for the treatment of benign prostatic hypertrophy (BPH) in male dogs and recommended that Ypozane be given a marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je sklenil, da so koristi zdravila Ypozane pri zdravljenju benigne hipertrofije prostate (BPH) pri psih samcih večje od z njim povezanih tveganj, zato je priporočil, da se za zdravilo Ypozane podeli dovoljenje za promet.
Ypozane are round, white tablets that contain osaterone acetate as the active substance. 
Zdravilo Ypozane so okrogle bele tablete, ki vsebujejo učinkovino osateronijev acetat.
What is Ypozane used for? 
Za kaj se zdravilo Ypozane uporablja?
How has Ypozane been studied? 
Kako je bilo zdravilo Ypozane raziskano?
What is Ypozane? 
Kaj je zdravilo Ypozane?
How does Ypozane work? 
Kako zdravilo Ypozane deluje?
The situation, therefore, will be continuously monitored 
Zato se bodo razmere stalno spremljale.
Part of the new legislation has already come into effect and been implemented. 
Del nove zakonodaje je že začel veljati in se izvajati.
He also holds an MBA. 
Ima tudi MBA.
It is also planned to transform this working group into a standing working party. 
Načrtuje se tudi preoblikovanje te delovne skupine v stalno delovno skupino.
He was also responsible for a laboratory unit. 
Bil je tudi odgovoren za laboratorijsko enoto.
For more information please refer to section 2.12. 
Za več informacij glejte, prosimo, razdelek 2.12 zgoraj.
The implementation strategy concentrates on a number of projects with high European added value. 
Izvedbena strategija je usmerjena k številnim projektom z visoko stopnjo evropske dodane vrednosti.
(draft budget) 
(predlog proračuna)
Relations and exchange of information with the European Parliament Environment, Public Health and Food Safety Committee. 
Odnosi in izmenjava informacij z Odborom Evropskega parlamenta za okolje, javno zdravje in varno hrano.
To be revised and updated (jointly with Health Canada) 
Se revidira in posodobi (skupaj s Health Canada)
Eleven meetings will be held that will run for at least two full days. 
Imela bo enajst zasedanj, ki bodo trajala vsaj dva polna dneva.
Examples of areas where clarification is necessary include: 
Med primere področij, kjer je potrebna pojasnitev, spadajo:
EU telematics is a priority area for the Agency. 
Telematika EU je prednostno področje Agencije.
This first full year of operation as an EU of 25 Member States will, however, increase the activity levels of the network, and will require strong cooperation between its partners. 
To prvo polno leto delovanja kot EU 25 držav članic bo povečalo ravni dejavnosti mreže in zahtevalo tesno sodelovanje med njenimi partnerji.
However, it should be noted that the implementation of the new Community legislation could result in a significant increase if parallel distributors were to systematically use the new legal provision. 
Vendar pa je treba opozoriti, da ima izvajanje nove zakonodaje Skupnosti lahko za posledico znatno povečanje, če bodo vzporedni distributerji sistematično uporabljali nove predpise.
Processing the delegates' expenses reimbursement within two weeks after the meeting ends 
Obravnavati povračilo stroškov delegatov v dveh tednih po zaključku sestanka.
Some reasons for this: 
Nekateri razlogi za to so:
This list should be submitted by the Member States by 30 April 2005 and is expected to be rather extensive 
Države članice morajo ta seznam predložiti do 30. aprila 2005, predvidoma pa bo precej dolg.
No meeting in August 
Avgusta ne bo zasedanja
Adopted by the Management Board on 16 December 2004 
Sprejel upravni odbor dne 16. decembra 2004
Continuous support to observers from candidate countries 
Stalna podpora opazovalcem iz držav kandidatk.
Details of all planned guidance documents are included in Annex 3. 
Podrobnosti o vseh predvidenih usmeritvenih dokumentih so vključene v Prilogo 3.
In addition to its responsibilities in the field of budgetary, planning and reporting matters, the Management Board will carry out these important tasks: 
Poleg svojih pristojnosti na področju proračuna, načrtovanja in poročanja bo upravni odbor izvajal naslednje pomembne naloge:
New Member States will participate for the first time in the sampling part of the programme. 
Nove države članice bodo v delu programa, namenjenem vzorčenju, sodelovale prvič.
To streamline and optimise the organisation of meetings to achieve the highest possible standard. 
Poenostaviti in optimizirati organiziranje sestankov, da se doseže najvišji možni standard.
Corresponding strategies and policies will be prepared in 2005. 
Ustrezne strategije in politike bodo pripravljene leta 2005.
Improvement of the two programmes will enable the Agency to manage the organisation of meetings more effectively. 
Izboljšanje obeh programov bo Agenciji omogočilo učinkovitejše organiziranje sestankov.
Emphasis is made on provision of information which is better adapted to its users. 
Poudarek je na zagotavljanju informacij, ki so bolje prilagojene uporabnikom.
Personnel and budget 
Osebje in proračun
The existing 1991 guideline to be revised to include a section on Positron Emission Tomography (PET) 
Sedanja smernica iz leta 1991 se revidira, da se vključi oddelek o pozitronski emisijski tomografiji (PET)
For this reason, the Administration unit maintains regular contacts with the above institutions and with the other European agencies. 
Zato ima upravna enota redne stike z navedenimi institucijami in drugimi evropskimi agencijami.
To address specific needs for new technologies 
Obravnavati posebne potrebe za nove tehnologije.
To provide the best possible support and assistance to delegates attending meetings 
Zagotoviti najboljšo možno podporo in pomoč delegatom, ki se udeležijo sestankov.
The number of type II variation applications remains at the previous year's level. 
Število vlog za spremembe tipa II ostaja na ravni preteklega leta.
To ensure a safe and efficient work environment for staff, delegates and visitors 
Zagotavljati varno in učinkovito delovno okolje za osebje, delegate in obiskovalce.
In addition, the centralised procedure is open to any other product that constitutes a significant innovation or for which there is a Community interest. 
Poleg tega je centralizirani postopek dostopen za vse druge izdelke, ki so pomembna inovacija ali za katere obstaja interes Skupnosti.
The impact of new approaches to manufacturing and control methods (PAT) will be addressed in the framework of the EU PAT team. 
Vpliv novih pristopov na postopke izdelave in nadzora (PAT) se bo obravnaval v okviru skupine EU PAT.
Review and possible revision of the guideline. 
Pregled in možna revizija smernice.
The key objectives and priorities for 2005 can be summarised as follows: 1. 
Ključni cilji in prednostne naloge za leto 2005 se lahko povzamejo, kot sledi:
Annual reports to be carried out for 37 products, prepared in cooperation with rapporteur and corapporteur 
Letna poročila za 37 izdelkov, pripravljena v sodelovanju s poročevalcem in soporočevalcem.
In addition, the new legislation aims to help small and medium-sized enterprises to access the centralised procedure. 
Cilj nove zakonodaje je tudi pomagati majhnim in srednje velikim podjetjem, da jim bo dostopen centralizirani postopek.
This advice is provided in the form of protocol assistance that can also include advice on the significant benefit of a product. 
To svetovanje poteka v obliki pomoči pri protokolu, ki lahko vključuje tudi svetovanje o pomembni koristi izdelka.
Some deadlines were shortened in the existing approval process. 
Nekateri roki iz obstoječega postopka odobritve so bili skrajšani.
That collaboration has already resulted in significant achievements over the past 10 years, and ongoing commitment from all partners will secure our position as one of the foremost regulatory systems in the world. 
Takšno sodelovanje je že imelo svoje rezultate v pomembnih dosežkih zadnjih desetih let, stalna predanost vseh partnerjev pa bo utrdila naš položaj enega najboljših regulativnih sistemov na svetu.
An extensive consultation exercise with all interested parties in 2004 on the implementation of the new tools provided more details on the specific activities to be undertaken. 
Obsežno posvetovanje z vsemi zainteresiranimi stranmi leta 2004 o izvajanju novih orodij je zagotovilo več podrobnosti o posebnih dejavnostih, ki se jih je treba lotiti.
Anticipated enlargement of the European Union in 2007 
Predvidena širitev Evropske unije leta 2007.
The committees are to be kept informed on scientific and technological development in this scientific area 
Odbore je treba redno obveščati o znanstvenem in tehnološkem razvoju na tem znanstvenem področju.
The partners of the European medicines network have set themselves an important goal to enhance overall quality of the EU regulatory system. 
Partnerji Evropske mreže zdravil so si zastavili pomemben cilj izboljšati celotno kakovost regulativnega sistema EU.
1.5 Transparency and communication in the European network 
1.5 Preglednost in obveščanje v Evropski mreži