natgillin/translations-raw huggingface dataset:
What measures are being taken to ensure the safe and effective use of Xtandi? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xtandi?
Xtandi received a marketing authorisation valid throughout the EU on 21 June 2013. 
Za zdravilo Xtandi je bilo 21. junija 2013 izdano dovoljenje za promet, veljavno po vsej EU.
The Agency therefore concluded that Xtandi's benefits are greater than its risks and it can be authorised for use in the EU. 
Agencija je zato zaključila, da so koristi zdravila Xtandi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Xtandi is available as capsules (40 mg) and tablets (40 and 80 mg) and can only be obtained with a prescription. 
Zdravilo Xtandi je na voljo v obliki kapsul (40 mg) in tablet (40 mg in 80 mg), njegovo predpisovanje in izdaja pa je le na recept.
• treatment with docetaxel (a cancer medicine) has not worked or no longer works; or 
• zdravljenje z docetakselom (zdravilom proti raku) ni delovalo ali ne deluje več ali
Why is Xtandi authorised in the EU? 
Zakaj je zdravilo Xtandi odobreno v EU?
As for all medicines, data on the use of Xtandi are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Xtandi stalno spremljajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xtandi have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Xtandi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Other important side effects include falls, cognitive disorder (problems with thinking, learning and memory), and neutropenia (low levels of neutrophils, a type of white blood cells). 
Drugi pomembni neželeni učinki so padci, kognitivna motnja (težave z razmišljanjem, učenjem in spominom) in nevtropenija (nizke ravni nevtrofilcev, vrste belih krvnih celic).
The most common side effects with Xtandi (which may affect more than 1 in 10 people) are tiredness, fractures (broken bones), hot flushes and hypertension (high blood pressure). 
Najpogostejši neželeni učinki zdravila Xtandi (ki lahko prizadenejo več kot 1 osebo od 10) so utrujenost, zlomi kosti, vročinski oblivi in hipertenzija (visok krvni tlak).
An overview of Xtandi and why it is authorised in the EU 
Pregled zdravila Xtandi in zakaj je odobreno v EU
What benefits of Xtandi have been shown in studies? 
Kakšne koristi je zdravilo Xtandi izkazalo v študijah?
The European Medicines Agency considered that the anticancer effects of Xtandi had been clearly demonstrated and that its benefit in prolonging life for patients with metastatic disease is important for patients. 
Evropska agencija za zdravila je ocenila, da so protirakavi učinki zdravila Xtandi jasno dokazani in da je njegova korist glede podaljševanja življenja bolnikov z metastatskim rakom pomembna za bolnike.
The medicine contains the active substance enzalutamide. 
Zdravilo vsebuje zdravilno učinkovino enzalutamid.
Other information about Xtandi 
Druge informacije o zdravilu Xtandi
What is Xtandi and what is it used for? 
Kaj je zdravilo Xtandi in za kaj se uporablja?
• hormone therapy has not worked, and the patient has either no symptoms or mild symptoms and does not yet require chemotherapy (another type of cancer treatment). 
• hormonsko zdravljenje ni delovalo in bolnik nima simptomov oziroma ima blage simptome in kemoterapija (druga vrsta zdravljenja raka) pri njem še ni potrebna.
For more information about using Xtandi, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Xtandi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
In addition, seizures (fits) can occur in around 4 patients in 1,000. 
Poleg tega lahko pri približno štirih bolnikih od 1 000 pride do epileptičnih napadov (krčev).
It is used when the cancer is metastatic (has spread to other parts of the body), castration resistant (worsens despite treatment to lower production of testosterone or after surgical removal of the testes) and when either: 
Uporablja se, kadar je rak metastaziral (se razširil na druge dele telesa), je odporen na kastracijo (se poslabšuje kljub zdravljenju za zmanjšanje tvorjenja testosterona ali po kirurški odstranitvi testisov) in kadar bodisi:
Side effects reported with Xtandi are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Xtandi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What are the risks associated with Xtandi? 
Kakšna tveganja so povezana z zdravilom Xtandi?
Because prostate cancer needs testosterone and other male hormones to survive and grow, by blocking the effects of these hormones, enzalutamide slows down the growth of the prostate cancer. 
Ker rak prostate za preživetje in rast potrebuje testosteron in druge moške hormone, enzalutamid z zaviranjem teh hormonov upočasni rast raka prostate.
Xtandi has also been shown to delay the development of metastatic disease. 
Dokazano je bilo tudi, da zdravilo Xtandi zakasni razvoj metastatske oblike bolezni.
The active substance in Xtandi, enzalutamide, works by blocking the action of the male hormone testosterone and other male hormones known as androgens. 
Zdravilna učinkovina v zdravilu Xtandi, enzalutamid, deluje tako, da zavira delovanje moškega hormona testosterona in drugih moških hormonov, imenovanih androgeni.
The company that markets Xtandi will provide the results of an ongoing study on the long-term effects of Xtandi in men with non-metastatic prostate cancer. 
Podjetje, ki trži zdravilo Xtandi, bo zagotovilo rezultate tekoče študije o dolgoročnih učinkih zdravila Xtandi pri moških z nemetastatskim rakom prostate.
Enzalutamide does this by blocking the receptors to which these hormones attach. 
Enzalutamid zavira njihovo delovanje tako, da zavre receptorje, na katere se ti hormoni vežejo.
Xtandi can also be used for castration-resistant prostate cancer that is not metastatic (has not yet spread) but is at high risk of doing so. 
Zdravilo Xtandi se lahko uporablja tudi za zdravljenje na kastracijo odpornega raka prostate, ki še ni metastaziral (se ni razširil), vendar obstaja velika nevarnost, da se bo.
Xtandi is a cancer medicine used to treat men with prostate cancer. 
Xtandi je zdravilo proti raku, ki se uporablja za zdravljenje raka prostate pri moških.
Regarding its safety, the side effects with Xtandi were generally mild and could be managed appropriately. 
Kar zadeva varnost, so bili neželeni učinki zdravila Xtandi v splošnem blagi in jih je bilo mogoče ustrezno obravnavati.
Treatment with Xtandi should be started and monitored by a doctor who has experience in treating prostate cancer. 
Zdravljenje z zdravilom Xtandi mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
In addition, patients treated with Xtandi lived for longer without their disease showing signs of worsening in a radiographic scan: 20 months compared with 5 months for patients treated with placebo. 
Poleg tega so bolniki, zdravljeni z zdravilom Xtandi, dlje živeli brez znakov poslabšanja bolezni, vidnih na radiografski sliki, in sicer 20 mesecev v primerjavi s pet mesecev pri bolnikih, ki so prejemali placebo.
Xtandi has also been compared with placebo in a second main study involving 1,717 patients with metastatic, castration-resistant prostate cancer in whom hormone therapy had failed, but who had no symptoms or mild symptoms and had not previously been treated with chemotherapy. 
Zdravilo Xtandi so primerjali s placebom tudi v drugi glavni študiji, ki je vključevala 1 717 bolnikov z metastatskim rakom prostate, odpornim na kastracijo, pri katerih hormonsko zdravljenje ni bilo uspešno, ki pa niso imeli simptomov oziroma so imeli le blage simptome in predhodno niso bili zdravljeni s kemoterapijo.
The doctor may have to reduce the dose or interrupt treatment if a patient gets certain side effects. 
Če se pri bolniku pojavijo določeni neželeni učinki, bo zdravnik morda zmanjšal odmerek ali začasno prekinil zdravljenje.
In this study, Xtandi was more effective than placebo at prolonging patients' lives: on average, patients treated with Xtandi lived for 18 months, compared with 14 months for patients given placebo. 
V tej študiji je zdravilo Xtandi učinkoviteje od placeba podaljšalo življenje bolnikov: povprečno so bolniki, zdravljeni z zdravilom Xtandi, živeli 18 mesecev, bolniki, zdravljeni s placebom, pa 14 mesecev.
How does Xtandi work? 
Kako zdravilo Xtandi deluje?
How is Xtandi used? 
Kako se zdravilo Xtandi uporablja?
Xtandi has been compared with placebo in a study involving 1,401 patients with castration-resistant prostate cancer at high risk of becoming metastatic. 
Zdravilo Xtandi so primerjali s placebom v študiji, ki je zajela 1 401 bolnika z rakom prostate, odpornim na kastracijo, za katerega obstaja velika nevarnost, da bo metastaziral.
Xtandi has been compared with placebo (a dummy treatment) in a main study involving 1,199 patients with metastatic, castration-resistant prostate cancer who were previously treated with docetaxel. 
Zdravilo Xtandi so primerjali s placebom (zdravilom brez učinkovine) v glavni študiji, ki je vključevala 1 199 bolnikov z metastatskim rakom prostate, odpornim na kastracijo, ki so bili predhodno zdravljeni z docetakselom.
The average survival of patients treated with Xtandi was around 32 months compared with 30 months for patients treated with placebo. 
Povprečno skupno preživetje pri bolnikih, ki so bili zdravljeni z zdravilom Xtandi, je bilo približno 32 mesecev, pri bolnikih, ki so bili zdravljeni s placebom, pa 30 mesecev.
Patients treated with Xtandi lived for an average of 37 months without their disease becoming metastatic compared with 15 months on placebo. 
Bolniki, ki so prejemali zdravilo Xtandi, so v povprečju živeli 37 mesecev brez metastaz, medtem ko je bilo pri bolnikih, ki so prejemali placebo, to obdobje dolgo okoli 15 mesecev.
For the full list of side effects with Xtandi, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Xtandi, glejte navodilo za uporabo.
Strength Pharmaceutical form Route of administration 
Jakost Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
The European Commission issued a decision on 06 March 2009. 
Evropska komisija je odločbo izdala dne 6. marca 2009.
Ref. EMEA/CHMP/173455/2009 
EMEA/CHMP/173453/2009
Dr. Antonio Addis (Italy) 
dr. Antonio Addis (Italija)
Dr Catherine Moraiti (Greece) 
dr. Catherine Moraiti (Grčija)
The company wanted the authorisation to be recognised in Austria, Denmark, Germany, Greece, Hungary, Poland, Portugal and Sweden (the concerned Member States). 
Družba je želela, da dovoljenje za promet z zdravilom priznajo tudi v Avstriji, na Danskem, v Nemčiji, Grčiji, na Madžarskem, Poljskem, Portugalskem in Švedskem (zadevne države članice).
Why was Uman Big reviewed? 
Zakaj je bilo zdravilo Uman Big pregledano?
London, 09 March 2009 Doc. 
London, 9. marca 2009 Sklic na dok.
virus; including those whose vaccination is incomplete or status unknown; 
vključno s tistimi, pri katerih cepljenje ni popolno ali je status neznan;
On 31 October 2008, the Italian medicines agency, Agenzia Italiana del Farmaco, referred the matter to the CHMP. 
Italijanska agencija za zdravila Agenzia Italiana del Farmaco je 31. oktobra 2008 zadevo napotila na CHMP.
The grounds for the referral were concerns over the insufficiency of the clinical data submitted to establish the efficacy of the product. 
Razlogi za napotitev so bili zadržki glede nezadostnih kliničnih podatkov, predloženih za določitev učinkovitosti zdravila.
• in haemodialysed patients (patients whose kidneys have failed and who rely on a blood purification technique called haemodialysis), until vaccination has become effective; 
• pri hemodializnih bolnikih (bolnikih, pri katerih so ledvice odpovedale in ki so odvisni od tehnike prečiščevanja krvi, imenovane hemodializa), dokler cepljenje ne postane učinkovito;
What is Uman Big? 
Kaj je zdravilo Uman Big?
Based on evaluation of the currently available data and the scientific discussion within the Committee and at the CHMP's Blood Products Working Party, the CHMP concluded that the benefits of Uman Big outweigh its risks, and that therefore the marketing authorisation for Uman Big should be granted in all concerned member states. 
Na podlagi vrednotenja trenutno razpoložljivih podatkov in znanstvene razprave znotraj Odbora ter njegove Delovne skupine za krvne proizvode je CHMP zaključil, da koristi zdravila Uman Big odtehtajo njegova tveganja ter da je zato treba dovoljenje za promet z zdravilom Uman Big odobriti v vseh zadevnih državah članicah.
• in subjects who did not show an immune response after vaccination (and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B. 
• pri osebah, pri katerih se ni pokazal imunski odziv po cepljenju (in pri katerih je stalno preprečevanje nujno zaradi stalnega tveganja za okužbo s hepatitisom B).
The review was carried out under an ‘Article 29' referral1. 
Pregled se je opravil v skladu z napotitvijo iz člena 291.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Uman Big outweigh its risks, and that the marketing authorisation granted in Italy can be recognised in other Member States of the European Union and the European Economic Area. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da koristi zdravila Uman Big odtehtajo njegova tveganja ter se lahko dovoljenje za promet z zdravilom, odobreno v Italiji, prizna v drugih državah članicah Evropske unije in Evropskega gospodarskega prostora.
In addition, the absence of product specific safety data or postmarketing safety data was raised as a concern. 
Poleg tega se je pojavil zadržek zaradi pomanjkanja varnostnih podatkov ali postmarketinških podatkov o varnosti za to zdravilo.
The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Uman Big 180 IU/ml, solution for injection. 
Evropska agencija za zdravila (EMEA) je zaključila napotitveni postopek na podlagi nesoglasja med državami članicami Evropske unije v zvezi z odobritvijo zdravila Uman Big i.e./ml, raztopine za injiciranje.
• in case of accidental exposure in people who have not been vaccinated against the hepatitis B 
• v primeru nenamerne izpostavitve virusu pri ljudeh, ki niso bili cepljeni proti virusu hepatitisa B,
Kedrion S.p.A. submitted Uman Big for mutual recognition on the basis of the initial authorisation granted by Italy on 2 June 1979. 
je predložila vlogo za medsebojno priznavanje zdravila Uman Big na podlagi prvotnega dovoljenja za promet z zdravilom, odobrenega v Italiji dne 2. junija 1979.
• in the newborn of a hepatitis B virus carrier-mother; 
• pri novorojenčkih, katerih mati je prenašalka virusa hepatitisa B;
Uman Big is given as an intramuscular (into the muscle) injection to prevent hepatitis B in the following cases: 
Imunoglobulini proti hepatitisu B vsebujejo zelo visoke ravni protiteles proti virusu hepatitisa B. Zdravilo Uman Big se daje kot intramuskularna injekcija (v mišico) za preprečevanje hepatitisa B v naslednjih primerih:
Human Hepatitis B Immunoglobulins, 180 IU/ml, solution for injection 
Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Uman Big humani imunoglobulini proti hepatitisu B, 180 i.e./ml, raztopina za injiciranje
Immunoglobulins are blood proteins that have been extracted from donor plasma. 
Zdravilo Uman Big je raztopina humanih imunoglobulinov proti hepatitisu B. Imunoglobulini so krvne beljakovine, ki se pridobivajo iz darovane plazme.
The European Commission issued a decision on 25 May 2012. 
Evropska komisija je odločbo izdala 25. maja 2012.
It can be used in adults, adolescents and children from nine months of age. 
Lahko se uporablja pri odraslih, mladostnikih in otrocih od devetih mesecev starosti.
Priorix is marketed in all EU Member States as well as in Norway and Iceland. 
Zdravilo Priorix je na voljo v vseh državah članicah EU ter na Norveškem in Islandiji.
Why was Priorix reviewed? 
Zakaj je bilo zdravilo Priorix pregledano?
Priorix is authorised in the EU via national procedures. 
Zdravilo Priorix so odobrili v EU z nacionalnimi postopki.
On 15 March 2012, the European Medicines Agency completed a review of Priorix. 
Evropska agencija za zdravila je 15. marca 2012 zaključila pregled zdravila Priorix.
The CHMP also harmonised other sections of the SmPC, including sections 4.4 (warnings and precautions for use), 4.5 (interaction with other medicinal products and other forms of interaction), 4.6 (fertility, pregnancy and lactation) and 5.1 (pharmacodynamic properties). 
Odbor CHMP je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavji 4.4 (Posebna opozorila in previdnostni ukrepi), 4.5 (Medsebojno delovanje z drugimi zdravili in druge oblike interakcij), 4.6 (Plodnost, nosečnost in dojenje) in 5.1 (Farmakodinamične lastnosti).
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Priorix in the European Union (EU). 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je potrebna uskladitev informacij o predpisovanju zdravila Priorix v Evropski uniji (EU).
The company that markets the medicine is GlaxoSmithKline (GSK) Biologicals. 
Trži ga farmacevtska družba GlaxoSmithKline (GSK) Biologicals.
This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed. 
To je povzročilo razlike med državami članicami glede načina, kako se zdravilo lahko uporablja, kar se izraža v razlikah med povzetki glavnih značilnosti zdravila, označevanji in navodili za uporabo v državah, v katerih se zdravilo trži.
Due to the divergent national positions, on 20 May 2011, GlaxoSmithKline Biologicals referred the matter to the CHMP in order to harmonise the marketing authorisations for Priorix in the EU. 
Zaradi razlik med državami je družba GlaxoSmithKline Biologicals 20. maja 2011 zadevo napotila odboru CHMP, ki naj bi uskladil dovoljenja za promet z zdravilom Priorix v EU.
The CHMP recommended that this should be harmonised to nine months of age. 
Odbor CHMP priporoča, da se ta meja uskladi na devet mesecev starosti.
There was some inconsistency between EU countries regarding the use of Priorix in patients infected with HIV. 
Med državami EU je bilo nekaj neskladnosti pri uporabi cepiva Priorix pri bolnikih, okuženih z virusom HIV.
The CHMP recommended arranging this section according to the dosing recommendations for different age groups. 
Odbor CHMP je priporočil ureditev tega poglavja po priporočilih za odmerjanje v različnih starostnih skupinah.
Priorix is also contraindicated in people with certain other conditions which severely weaken the immune system. 
Cepivo Priorix je kontraindicirano tudi pri osebah z nekaterimi drugimi boleznimi, ki zelo oslabijo imunski sistem.
However, since a single dose of Priorix produces a lower immune response in children under 12 months old, the CHMP decided to include a reference to the other sections containing specific information on the use of Priorix in children between nine and 12 months old. 
Ker pa enkratni odmerek cepiva Priorix povzroča manjši imunski odziv pri otrocih, mlajših od 12 mesecev, je Odbor odločil, da je treba vključiti sklic na druga poglavja, ki vsebujejo specifične informacije o uporabi cepiva Priorix pri otrocih, starih med devet in 12 mesecev.
What is Priorix? 
Kaj je zdravilo Priorix?
The CHMP decided to contraindicate the use of Priorix in people with symptomatic, advanced HIV, since these patients have a severely weakened immune system which puts them at risk of serious health problems following vaccination with attenuated measles virus. 
Odbor CHMP se je odločil za kontraindikacijo cepiva Priorix pri osebah s simptomatsko, napredovalo okužbo z virusom HIV, saj imajo ti bolniki zelo oslabljen imunski sistem in so zato po cepljenju z oslabljenim virusom ošpic v nevarnosti za resne zdravstvene težave.
Priorix contains small amounts of attenuated (weakened) forms of the viruses that cause measles, mumps and rubella. 
Zdravilo Priorix vsebuje majhne količine atenuiranih (oslabljenih) oblik virusov, ki povzročajo ošpice, mumps in rdečke.
For children between nine and 12 months old, the CHMP decided to include a recommendation to give a second dose preferably within three months of the first dose. 
V zvezi z otroki, starimi od 9 do 12 mesecev, se je odbor CHMP odločil vključiti priporočilo, da po možnosti drugi odmerek dobijo v treh mesecih po prvem.
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU. 
Odbor CHMP je ob upoštevanju predloženih podatkov in znanstvene razprave v Odboru menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo uskladiti v vsej EU.
When a person is given Priorix, the immune system recognises the viruses as ‘foreign' and makes antibodies against them. 
Ko oseba prejme cepivo Priorix, imunski sistem prepozna bakterijo v cepivu kot „tujek“ in proti njej razvije protitelesa.
There was some inconsistency between EU countries regarding the approved lower age limit for Priorix, which varied from nine months to 15 months of age. 
Med državami EU je bilo nekaj neskladnosti pri odobreni spodnji starostni meji za uporabo cepiva Priorix, ki je bila v razponu od devet do 15 mesecev starosti.
In the future, the immune system will be able to produce antibodies more quickly when it is exposed to these viruses. 
Imunski sistem bo tako ob ponovni izpostavitvi virusom hitreje tvoril protitelesa.
Priorix is a vaccine used to protect against measles, mumps and rubella (German measles). 
Zdravilo Priorix je cepivo, ki se uporablja za zaščito proti ošpicam, mumpsu in rdečkam (rubella).
The review of Zydelig was initiated at the request of the European Commission on 17 March 2016, under Article 20 of Regulation (EC) No 726/2004. 
Pregled zdravila Zydelig se je pričel 17. marca 2016 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
In its review the PRAC evaluated data from these studies, together with other available evidence as well as advice from experts in this field. 
Pri svojem pregledu je odbor PRAC ovrednotil podatke iz teh študij skupaj z drugimi razpoložljivimi dokazi in nasveti strokovnjakov s tega področja.
A letter will be sent to healthcare professionals, advising them of these changes. 
Zdravstveni delavci bodo pisno obveščeni o teh spremembah.
If you are taking Zydelig and have any questions or concerns speak to your doctor, nurse or pharmacist. 
Če jemljete zdravilo Zydelig in imate kakršna koli vprašanja ali pomisleke, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
1 17p deletion or TP53 mutation, see http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/03/news_detail_002490.jsp 
1 Delecija 17p ali mutacija TP53, glejte http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/03/news_detail_002490.jsp.
The relevance of these results to the authorised use of Zydelig is therefore limited, but suggests a need to strengthen measures to minimise the risk of infection. 
Pomen teh rezultatov za odobreno uporabo zdravila Zydelig je zato omejen, vendar pa kaže potrebo po okrepitvi dejavnosti za zmanjševanje tveganja za okužbo.