natgillin/translations-raw huggingface dataset:
In addition, an inspection of one of the sites where the main study was carried out raised some concerns over the way the results were recorded, which could have further affected the reliability of the main study. 
Poleg tega je inšpekcijski pregled ene izmed lokacij, kjer je bila izvedena glavna študija, vzbudil nekaj dvomov glede beleženja rezultatov, kar lahko še nadalje okrni zanesljivost glavne študije.
The evaluation had finished and the CHMP had given a negative opinion, which had been confirmed following a re-examination procedure. 
Postopek ocenjevanja je bil zaključen in CHMP je izrazil negativno mnenje, ki ga je potrdil tudi postopek ponovne presoje.
Lenalidomide has been authorised in the European Union since June 2007 under the name Revlimid, for the treatment of multiple myeloma. 
Lenalidomid je v Evropski uniji odobren od junija 2007 pod imenom Revlimid za zdravljenje multiplega mieloma.
The main measure of effectiveness was the proportion of patients who became ‘transfusion independent', meaning that their anaemia was controlled without the need for a blood transfusion over an eight-week period. 
Glavno merilo učinkovitosti je bil delež bolnikov, ki so postali „neodvisni od transfuzije“, kar pomeni, da je bila njihova anemija v obdobju osmih tednov uravnana brez transfuzije krvi.
The effects of Lenalidomide Celgene Europe were first tested in experimental models before being studied in humans. 
Učinki zdravila Lenalidomide Celgene Europe so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The study looked at the effects of treatment with a daily dose of 10 mg Lenalidomide Celgene Europe either given continuously or as a repeated cycle of three weeks on treatment followed by one week off. 
Študija je preučevala učinke zdravljenja z dnevnim odmerkom 10 mg zdravila Lenalidomide Celgene Europe, ki so ga dajali bodisi neprekinjeno ali pa v ponavljajočem se ciklusu, ki je obsegal tri tedne prejemanja zdravila, ki jim je sledil en teden brez zdravila.
There are no consequences of this withdrawal on the use of Revlimid, which also contains lenalidomide, in its authorised indication. 
Umik nima nobenih posledic za uporabo zdravila Revlimid, ki prav tako vsebuje lenalidomid, za odobreno indikacijo.
The CHMP had concerns over the way the main study was carried out, which meant that the safety of Lenalidomide Celgene Europe was difficult to assess. 
CHMP je imel zadržke glede načina izvedbe glavne študije, zaradi česar je bilo težko oceniti varnost zdravila Lenalidomide Celgene Europe.
The exact way that lenalidomide works in myelodysplastic syndromes is not known, but it is thought that it blocks the growth of tumour cells in the bone marrow, while allowing the growth of normal bone marrow cells, including the cells that produce red blood cells. 
Natančen način delovanja lenalidomida pri mielodisplastičnih sindromih ni znan, vendar se domneva, da blokira rast tumorskih celic v kostnem mozgu, medtem ko dopušča rast normalnih celic kostnega mozga, vključno s celicami, ki tvorijo rdeče krvne celice.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for LENALIDOMIDE CELGENE EUROPE 
VPRAŠANJA IN ODGOVORI V ZVEZI Z UMIKOM VLOGE ZA DOVOLJENJE ZA PROMET z zdravilom LENALIDOMIDE CELGENE EUROPE
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Lenalidomide Celgene Europe? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Lenalidomide Celgene Europe?
Lenalidomide Celgene Europe was designated as an orphan medicinal product on 8 March 2004. 
Zdravilo Lenalidomide Celgene Europe je bilo dne 8. marca 2004 določeno kot zdravilo sirota.
In some cases, myelodysplastic syndromes can lead to the development of acute myeloid leukaemia (a type of cancer affecting the white blood cells). 
V nekaterih primerih lahko mielodisplastični sindromi privedejo do razvoja akutne mieloidne levkemije (vrste raka, ki prizadene bele krvne celice).
What is happening with Revlimid used for the treatment of multiple myeloma? 
Kaj to pomeni za nadaljnjo uporabo zdravila Revlimid, ki se uporablja za zdravljenje multiplega mieloma?
On 30 May 2008, Celgene Europe Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Lenalidomide Celgene Europe, for the treatment of anaemia due to myelodysplastic syndromes. 
Družba Celgene Europe Limited je dne 30. maja 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Lenalidomide Celgene Europe, namenjenim zdravljenju anemije, ki je posledica mielodisplastičnih sindromov.
The study involved 148 patients with transfusion-dependent anaemia, low or intermediate (level 1) risk myelodysplastic syndromes and a deletion of part of chromosome 5 (‘5q deletion'). 
Študija je vključevala 148 bolnikov z anemijo, ki zahteva transfuzije krvi, majhnim ali srednjim tveganjem (stopnja 1) za prisotnost mielodisplastičnih sindromov in izgubo dela kromosoma št. 5 („delecija 5q“).
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Lenalidomide Celgene Europe for the for the treatment of anaemia due to myelodysplastic syndromes. 
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil negativno mnenje in ni priporočil odobritve dovoljenja za promet z zdravilom Lenalidomide Celgene Europe, namenjenim zdravljenju anemije, ki je posledica mielodisplastičnih sindromov.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Lenalidomide Celgene Europe had not been sufficiently demonstrated and any benefits did not outweigh the identified risks. 
Zato je CHMP v času umika menil, da koristi zdravila Lenalidomide Celgene Europe niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
Multiple myeloma is a cancer of the plasma cells in the bone marrow. 
Multipli mielom je rak plazemskih celic v kostnem mozgu.
The company informed the CHMP that it will continue to make lenalidomide available for patients included in clinical trials or compassionate use programmes. 
Družba je obvestila CHMP, da bo bolnikom, vključenim v klinična preskušanja ali programe sočutne uporabe, še dalje omogočala dostop do lenalidomida.
Lenalidomide Celgene Europe was expected to be used to treat anaemia (low red blood cell counts) caused by myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow. 
Zdravilo Lenalidomide Celgene Europe naj bi se uporabljalo za zdravljenje anemije (nizkega števila rdečih krvnih celic), ki jo povzročajo mielodisplastični sindromi, skupina bolezni, pri katerih kostni mozeg tvori premalo krvnih celic.
Lenalidomide Celgene Europe is a medicine containing the active substance lenalidomide. 
Lenalidomide Celgene Europe je zdravilo, ki vsebuje zdravilno učinkovino lenalidomid.
Lenalidomide Celgene Europe was to be used in patients who were dependent on receiving blood transfusions to treat their anaemia and whose myelodysplastic syndromes were associated with a specific genetic mutation (deletion of part of chromosome number 5), and with a low to intermediate risk of progressing to leukaemia or death. 
Zdravilo Lenalidomide Celgene Europe naj bi se uporabljalo pri bolnikih, ki morajo za zdravljenje anemije prejemati transfuzije krvi in pri katerih so mielodisplastični sindromi povezani s specifično gensko mutacijo (izgubo dela kromosoma št. 5) in ki so izpostavljeni majhnemu ali srednjemu tveganju za napredovanje bolezni v levkemijo ali za nastop smrti.
The active substance in Lenalidomide Celgene Europe, lenalidomide, is an immunomodulating agent. 
Zdravilna učinkovina zdravila Lenalidomide Celgene Europe je lenalidomid, ki je imunomodulator.
What is Lenalidomide Celgene Europe? 
Kaj je zdravilo Lenalidomide Celgene Europe?
How is Lenalidomide Celgene Europe expected to work? 
Kako naj bi zdravilo Lenalidomide Celgene Europe delovalo?
What was Lenalidomide Celgene Europe expected to be used for? 
Za kaj naj bi se zdravilo Lenalidomide Celgene Europe uporabljalo?
In particular, because the study did not compare the medicine to any other treatment, it was difficult to determine if treatment with Lenalidomide Celgene Europe increased the risk of progression to acute myeloid leukaemia. 
Presoja, ali zdravljenje z zdravilom Lenalidomide Celgene Europe poveča tveganje za napredovanje bolezni v akutno mieloidno levkemijo, je bila otežena zlasti zato, ker študija ni primerjala zdravila z nobenim drugim zdravljenjem.
--1 Live attenuated Muscovy duck parvovirus ≥ 2.6 log10 CCID50 * * Cell culture infectious dose 50% 
--1 Atenuiran parvovirus rac moškatnih bleščavk, sev GM 199 ≥2,6 log10 CCID50* (*) 50% infektivni odmerek za celično kulturo
EU (MA) Number 
EU številka
Suspension and diluent for suspension for injection 
Suspenzija in vehikel za
10 vials Not applicable 
1 viala Ni smiselno
Not applicable 
Ni smiselno
Muscovy ducks 
Race moškatne
This summary was last updated in 12-2016. 
Povzetek je bil nazadnje posodobljen 12-2016.
The percentages of successful injections for the two groups were around 30% and 9%, respectively. 
Odstotek uspešnih injiciranj v obeh skupinah je bil okoli 30 % oziroma 9 %.
The European Commission granted a marketing authorisation valid throughout the European Union for Relistor on 2 July 2008. 
Evropska komisija je dovoljenje za promet z zdravilom Relistor, veljavno po vsej Evropski uniji, izdala 2. julija 2008.
The full EPAR for Relistor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Relistor je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
These side effects are generally mild or moderate. 
Ti neželeni učinki so bili običajno blagi ali zmerni.
This is a summary of the European public assessment report (EPAR) for Relistor. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Relistor.
The dose depends on the patient's body weight. 
Odmerek je odvisen od bolnikove telesne mase.
These receptors are also found in the gut. 
Ti receptorji so prisotni tudi v črevesju.
What measures are being taken to ensure the safe and effective use of Relistor? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Relistor?
The Agency's Committee for Medicinal Products for Human Use decided that Relistor's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Relistor večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Other information about Relistor 
Druge informacije o zdravilu Relistor
This means that it blocks a specific type of opioid receptor called the ‘mu-opioid receptor'. 
To pomeni, da zavira posebno vrsto opioidnih receptorjev, imenovanih muopioidni receptorji.
It is not intended to provide practical advice on how to use Relistor. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
In patients not on palliative care, Relistor is given as an injection under the skin at a dose of 12 mg once a day, for at least 4 days per week and up to 7 days per week as needed; treatment with usual laxatives should be stopped when starting Relistor. 
Pri bolnikih, ki ne prejemajo paliativne oskrbe, se zdravilo Relistor daje z injiciranjem v podkožje v odmerku 12 mg enkrat na dan, vsaj štirikrat na teden in največ sedem dni na teden, če je to potrebno; zdravljenje z običajnimi odvajalnimi zdravili je treba pred začetkom jemanja zdravila Relistor prenehati.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Relistor have 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 Relistor upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about treatment with Relistor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Relistor preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Relistor (seen in more than 1 patient in 10) are abdominal pain (stomach ache), nausea (feeling sick), diarrhoea and flatulence. 
Najpogostejši neželeni učinki zdravila Relistor (opaženi pri več kot 1 bolniku od 10) so abdominalne (trebušne) bolečine, navzeja (slabost), driska in napenjanje (vetrovi).
What is Relistor and what is it used for? 
Kaj je zdravilo Relistor in za kaj se uporablja?
What benefits of Relistor have been shown in studies? 
Kakšne koristi je zdravilo Relistor izkazalo v študijah?
Relistor methylnaltrexone bromide 
Relistor metilnaltreksonijev bromid
What are the risks associated with Relistor? 
Kakšna tveganja so povezana z zdravilom Relistor?
By blocking these receptors, Relistor reduces the constipation due to opioids, but does not interfere with their painkilling effects. 
Z zaviranjem teh receptorjev zdravilo Relistor zmanjšuje zaprtje zaradi opioidov, vendar ne vpliva na njihovo protibolečinsko delovanje.
Methylnaltrexone bromide is less able to enter the brain than naltrexone, meaning that it blocks the mu-opioid receptors in the gut but not in the brain. 
Metilnaltreksonijev bromid slabše prehaja v možgane kot naltrekson, kar pomeni, da zavira muopioidne receptorje v črevesju, ne pa tudi v možganih.
Why is Relistor approved? 
Zakaj je bilo zdravilo Relistor odobreno?
For practical information about using Relistor, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Relistor naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Relistor must not be used in patients whose bowel is blocked, who are at risk of recurrent bowel blockage or who have a condition that needs immediate bowel surgery. 
Zdravilo Relistor se ne sme uporabljati pri bolnikih, ki imajo obstrukcijo prebavil, pri katerih obstaja nevarnost za ponovitev obstrukcije prebavil, ali bolnikih z obolenjem, ki zahteva takojšnji kirurški poseg na prebavilih.
Relistor has also been compared with placebo in a third study involving 496 patients with constipation caused by opioids, but no advanced illness. 
Zdravilo Relistor so s placebom primerjali tudi pri 496 bolnikih, ki so bili zaprti zaradi jemanja opioidov, a niso imeli napredovale bolezni.
Relistor is not recommended for patients who have very severe kidney problems that require dialysis (a blood clearance technique). 
Zdravilo Relistor ni priporočljivo za bolnike, ki imajo hude težave z ledvicami, zaradi česar potrebujejo dializo (tehniko čiščenja krvi).
The main measures of effectiveness were the number of patients who had a bowel movement within four hours of the first dose, and the percentage of injections that were successful in producing a bowel movement. 
Glavno merilo učinkovitosti je bilo število bolnikov, ki so blato odvedli v štirih urah po prvem odmerku, in delež injekcij, ki so uspešno pospešile odvajanje blata.
Patients can inject Relistor themselves once they have been trained appropriately. 
Bolniki si lahko po ustreznem usposabljanju zdravilo Relistor injicirajo sami.
It is available as a solution for injection in vials or in prefilled syringes. 
Na voljo je v obliki raztopine za injiciranje v vialah ali napolnjenih brizgah.
The main measure of effectiveness in both studies was the number of patients who had a bowel movement within four hours of the first dose. 
Glavno merilo učinkovitosti pri obeh študijah je bilo število bolnikov, ki so odvedli blato v štirih urah po prvem odmerku.
Methylnaltrexone bromide is derived from naltrexone, a well-known substance that is used to block the action of opioids. 
Metilnaltreksonijev bromid se pridobiva iz naltreksona, dobro znane učinkovine, ki se uporablja za zaviranje delovanja opioidov.
The active substance in Relistor, methylnaltrexone bromide, is a ‘mu-opioid receptor antagonist'. 
Zdravilna učinkovina v zdravilu Relistor, metilnaltreksonijev bromid, je antagonist muopioidnih receptorjev.
Relistor is used to treat constipation caused by opioid painkillers (such as morphine) when laxative medicines have not worked well enough. 
Relistor se uporablja za zdravljenje zaprtja, ki ga povzročajo opioidna zdravila za lajšanje bolečin (kot je na primer morfin), kadar je odziv na odvajalno zdravljenje nezadosten.
For the full list of all side effects reported with Relistor, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Relistor, glejte navodilo za uporabo.
Relistor is usually injected under the skin of the upper legs, belly or upper arms. 
Zdravilo Relistor se običajno injicira v podkožje stegna, trebuha ali nadlahti.
Results showed that 34% of patients receiving Relistor (102 out of 298) had a bowel movement within four hours after the first injection, compared with 10% of those receiving placebo (16 out of 162). 
Rezultati so pokazali, da je 34 % (102 od 298) bolnikov, ki so prejeli zdravilo Relistor, blato odvedlo v štirih urah po prvem injiciranju zdravila v primerjavi z 10 % (16 od 162) tistih, ki so prejeli placebo.
The second study also looked at the number of patients who had a bowel movement at least twice within four hours of the first four doses. 
V drugi študiji so proučevali število bolnikov, pri katerih je do odvajanja blata prišlo vsaj dvakrat v štirih urah po prvih štirih odmerkih.
Opioids relieve pain by attaching to ‘opioid receptors' in the brain and spinal cord. 
Opioidi lajšajo bolečine tako, da se vežejo na receptorje opioidov v možganih in hrbtenjači.
When opioids attach to the gut receptors, the mobility of the gut is reduced, leading to constipation. 
Kadar se opioidi vežejo na receptorje v črevesju, se njegovo delovanje upočasni, kar povzroča zaprtje.
Relistor contains the active substance methylnaltrexone bromide. 
Zdravilo Relistor vsebuje zdravilno učinkovino metilnaltreksonijev bromid.
In the second study, 52% of the patients receiving Relistor had a bowel movement at least twice within four hours of the first four doses (32 out of 62), compared with 8% of those receiving placebo (6 out of 71). 
Pri drugi študiji je 52 % (32 od 62) bolnikov, ki so prejeli zdravilo Relistor, odvedlo blato vsaj dvakrat v štirih urah po prvih štirih odmerkih v primerjavi z 8 % (6 od 71) bolnikov, ki so prejeli placebo.
In patients who are receiving palliative care (treatment of the symptoms of a serious disease that is not intended to lead to cure), Relistor is given as an injection under the skin, once every two days, in addition to the usual laxative medicines. 
Zdravilo Relistor se pri bolnikih, ki prejemajo paliativno oskrbo (zdravljenje simptomov bolezni, ki pa ne vodi k ozdravitvi), injicira v podkožje vsak drugi dan poleg običajnih odvajalnih zdravil.
How does Relistor work? 
Kako zdravilo Relistor deluje?
Looking at the results of the two studies taken together, 55% of the patients receiving Relistor had a bowel movement within four hours of the first dose (91 out of 165), compared with 15% of the patients receiving placebo (18 out of 123). 
Skupni rezultati obeh študij kažejo, da je 55 % (91 od 165) bolnikov, ki so prejeli zdravilo Relistor, odvajalo blato v štirih urah po prvem injiciranju v primerjavi s 15 % (18 od 123) bolnikov, ki so prejeli placebo.
Relistor can only be obtained with a prescription. 
Predpisovanje in izdaja zdravila Relistor je le na recept.
Relistor was shown to be more effective than placebo (a dummy treatment) at stimulating bowel movement in two main studies involving a total of 288 patients with an advanced illness and constipation caused by opioids. 
Zdravilo Relistor se je v dveh glavnih študijah, v kateri je bilo vključenih skupaj 288 bolnikov z napredovalo boleznijo in zaprtjem, ki ga povzroča jemanje opioidov, izkazalo za učinkovitejše od placeba (zdravila brez zdravilne učinkovine) pri pospeševanju odvajanja blata.
How is Relistor used? 
Kako se zdravilo Relistor uporablja?
The dose of Relistor should be reduced in patients who have severe kidney problems. 
Pri bolnikih, ki imajo težko ledvično okvaro, je treba odmerek zdravila Relistor prilagoditi.
Key elements to be included in the educational material 
Ključni elementi, ki morajo biti vključeni v izobraževalnem materialu
• Information on the identified and potential risks. 
• informacije o znanih in možnih nevarnostih.
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 profesionalnimi informacijami, ki bo vseboval:
• Educational material 
• izobraževalni material,
• Summary of Product Characteristics (SPC) and Package Leaflet and Labelling 
• povzetek glavnih značilnosti zdravila (SPC) in navodilo za uporabo in označevanje.
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: 
Države članice morajo zagotoviti, da bodo izpolnjeni vsi pogoji ali uveljavljene vse omejitve za varno in učinkovito uporabo spodaj opisanih zdravil:
• Information on gel depot formation and possible injections site reactions 
• informacije o oblikovanju gelskega depoja in možnih reakcijah na mestu injiciranja,
• Instructions for administration 
• navodila za uporabo,
• Posology 
• odmerjanje,
The Reference Member States were Germany, Hungary, Norway, Poland, Slovakia, Spain, United Kingdom. 
Zadevne države članice so bile Nemčija, Madžarska, Norveška, Poljska, Slovaška, Španija in Združeno kraljestvo.
1 Article 29(2) of Directive 2001/83/EC, as amended. 
1 Člen 29(2) Direktive 2001/83/ES, kot je bila spremenjena.
The CHMP appointed Dr. J.F.F. 
CHMP je imenoval dr. J.F.F.
The final opinion was converted into a Decision by the European Commission on 11/10/2006. 
Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 11/10/2006.
Lekkerkerker (Netherlands) as Rapporteur and Dr. Hudson (United Kingdom) as Co-rapporteur. 
Lekkerkerkerja (Nizozemska) za poročevalca in dr. Hudsona (Združeno kraljestvo) za soporočevalca.
A positive opinion was adopted 28 June 2006. 
Pozitivno mnenje je bilo sprejeto 28. junija 2006.
The Mutual Recognition Procedure started on 21 October 2005. 
Postopek za medsebojno priznavanje se je začel 21. oktobra 2005.
The Denmark referred the reasons for disagreement to the EMEA on 31 March 2006. 
Danska je agenciji EMEA posredovala razloge za nesoglasje dne 31. marca 2006.
These Member States were not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State. 
Omenjene države članice niso mogle doseči soglasja v zvezi z medsebojnim priznavanjem dovoljenja za promet z zdravilom, ki ga je izdala referenčna država članica.