natgillin/translations-raw huggingface dataset:
The European Commission granted a marketing authorisation valid throughout the European Union for Dacogen on 20 September 2012. 
Evropska komisija je dovoljenje za promet z zdravilom Dacogen, veljavno po vsej Evropski uniji, izdala 20. septembra 2012.
At least 4 treatment cycles are recommended but they can be continued for as long as the AML remains under control. 
Priporočeni so 4 cikli zdravljenja, lahko pa se nadaljujejo, dokler je AML pod nadzorom.
Treatment was given for as long as patients benefited from it. 
Zdravljenje se je izvajalo toliko časa, dokler je bolnikom koristilo.
These enzymes promote the development and progression of cancer. 
Ti so odgovorni za spodbujanje razvoja in napredovanja raka.
What measures are being taken to ensure the safe and effective use of Dacogen? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Dacogen?
In a 4-week treatment cycle, Dacogen is given daily for the first 5 days. 
Cikel zdravljenja traja štiri tedne, v katerem se zdravilo Dacogen daje dnevno prvih 5 dni.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dacogen have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Dacogen, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Patients receiving Dacogen lived for an average of 7.7 months compared with 5.0 months for patients receiving supportive care or treatment with cytarabine. 
Bolniki, ki so prejemali zdravilo Dacogen, so živeli v povprečju 7,7 meseca v primerjavi s 5 meseci pri bolnikih, ki so prejemali podporno zdravljenje ali zdravljenje s citarabinom.
This is a summary of the European public assessment report (EPAR) for Dacogen. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Dacogen.
For more information about treatment with Dacogen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Dacogen preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
The summary of the opinion of the Committee for Orphan Medicinal Products for Dacogen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote za zdravilo Dacogen je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The CHMP decided that Dacogen's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Dacogen večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
If a patient develops certain severe side effects, the doctor may decide to delay or stop Dacogen treatment. 
Če se pri bolniku pojavijo določeni resni neželeni učinki, se lahko zdravnik odloči za odložitev ali ukinitev zdravljenja z zdravilom Dacogen.
This means that it is similar to cytidine deoxynucleoside, a fundamental component of the DNA (genetic material) of cells. 
To pomeni, da je podoben citidinskemu deoksinukleozidu, temeljni sestavini DNK (genskega materiala) celic.
In the body, decitabine is converted into decitabine triphosphate, which is then incorporated into the DNA where it blocks the activity of enzymes called DNA methyltransferases (DNMTs). 
V telesu se decitabin pretvori v decitabin trifosfat, ki se nato vgradi v DNK, kjer zavira delovanje encimov, imenovanih DNA-metiltransferaze (DNMT).
It is used in patients who are not eligible for standard induction chemotherapy (initial treatment with cancer medicines). 
Uporablja se pri bolnikih, za katere standardna indukcijska kemoterapija (začetno zdravljenje z zdravili za zdravljenje raka) ni primerna.
Because the number of patients with AML is low, the disease is considered ‘rare', and Dacogen was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 June 2006. 
Ker je bolnikov z AML malo, velja ta bolezen za redko, zato je bilo zdravilo Dacogen 8. junija 2006 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
What benefit has Dacogen shown during the studies? 
Kakšne koristi je zdravilo Dacogen izkazalo med študijami?
Dacogen is used to treat adults with newly diagnosed acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells. 
Zdravilo Dacogen se uporablja za zdravljenje odraslih z novo diagnosticirano akutno mieloično levkemijo (AML), vrsto raka, ki prizadene bele krvne celice.
The CHMP noted that the improvement in survival with Dacogen in patients with AML was modest but relevant, as the benefits of current treatments are limited in patients who are not eligible for standard induction chemotherapy. 
CHMP je ugotovil, da je bilo izboljšanje preživetja pri uporabi zdravila Dacogen pri bolnikih z AML skromno, vendar pomembno, saj so koristi trenutno dostopnih zdravil za bolnike, za katere standardna indukcijska kemoterapija ni primerna, omejene.
Other information about Dacogen 
Druge informacije o zdravilu Dacogen:
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dacogen. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Dacogen, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
By blocking DNMTs, decitabine will prevent the increase of tumour cells and lead to their death. 
Z zaviranjem DNMT bo decitabin preprečil deljenje tumorskih celic in tako povzročil njihovo odmrtje.
Dacogen is given as an infusion into a vein over one hour. 
Zdravilo Dacogen se daje kot infuzija v veno, ki traja eno uro.
The dose is calculated using the patient's height and weight. 
Odmerek se izračuna na podlagi telesne višine in mase bolnika.
There were no major safety concerns with Dacogen and the overall safety profile was similar to that of low-dose cytarabine but some side effects such as infections and neutropenia were more common with Dacogen. 
Pri zdravilu Dacogen ni prišlo do večjih pomislekov glede varnosti, celotni varnostni profil pa je bil podoben profilu nizkega odmerka citarabina, z izjemo nekaterih neželenih učinkov, kot so okužbe in nevtropenija, ki so bili pri zdravilu Dacogen pogostejši.
Dacogen was compared with either supportive care (any medicine or technique to help patients, excluding cancer medicines or surgery) or low-dose cytarabine (another cancer medicine). 
Zdravilo Dacogen so primerjali bodisi s podpornim zdravljenjem (katero koli zdravilo ali tehnika za pomoč bolnikom razen zdravil za zdravljenje raka ali kirurškega posega) bodisi z nizkim odmerkom citarabina (drugega zdravila za zdravljenje raka).
As it is not known whether the active substance is excreted in breast milk, in the event that a patient is breastfeeding, they must discontinue breastfeeding if they require treatment with Dacogen. 
Ker ni znano, ali se zdravilna učinkovina izloča v materino mleko, mora bolnica, če doji, prekiniti z dojenjem v primeru, da potrebuje zdravljenje z zdravilom Dacogen.
Treatment with Dacogen should be started under the supervision of a doctor who has experience in the use of chemotherapy. 
Zdravljenje z zdravilom Dacogen mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo kemoterapije.
Dacogen has been studied in one main study involving 485 adults, who were newly diagnosed with AML but were not eligible for standard induction chemotherapy. 
Zdravilo Dacogen so proučevali v eni glavni študiji pri 485 odraslih z novo diagnosticirano AML, ki pa niso bili primerni za standardno indukcijsko kemoterpaijo.
The full EPAR for Dacogen 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 Dacogen je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dacogen must not be used in people who are breastfeeding. 
Zdravilo Dacogen se ne sme uporabljati pri ženskah, ki dojijo.
What is the risk associated with Dacogen? 
Kakšna tveganja so povezana z zdravilom Dacogen?
It contains the active substance decitabine. 
Vsebuje zdravilno učinkovino decitabin.
For the full list of all restrictions and side effects reported with Dacogen, see the package leaflet. 
Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Dacogen, glejte navodilo za uporabo.
The most common serious side effects (seen in more than 20% of patients) include pneumonia (lung infection), thrombocytopenia, neutropenia (low blood count of neutrophils, a type of white blood cell), febrile neutropenia (low white blood cell count with fever) and anaemia. 
Najpogostejši resni neželeni učinki (opaženi pri več kot 20 % bolnikov) so pljučnica (okužba pljuč), trombocitopenija, nevtropenija (nizko število nevtrofilcev, vrste bele krvnih celic), febrilna nevtropenija (nizko število belih krvnih celic, ki ga spremlja povišana telesna temperatura) in anemija.
Why has Dacogen been approved? 
Zakaj je bilo zdravilo Dacogen odobreno?
The active substance in Dacogen, decitabine, is a cytidine deoxynucleoside analogue. 
Zdravilna učinkovina v zdravilu Dacogen, decitabin, je „analog citidinskega deoksinukleozida“.
The most common side effects with Dacogen (seen in more than 35% of patients) are fever, anaemia (low red blood cell count) and thrombocytopenia (low blood platelet count). 
Najpogostejši neželeni učinki zdravila Dacogen (opaženi pri več kot 35 % bolnikov) so povišana telesna temperatura, anemija (nizko število rdečih krvnih celic) in trombocitopenija (nizko število krvnih ploščic).
Dacogen is a powder that is made up into a solution for infusion (drip) into a vein. 
Zdravilo Dacogen je prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
What is Dacogen? 
Kaj je zdravilo Dacogen?
What is Dacogen used for? 
Za kaj se zdravilo Dacogen uporablja?
How has Dacogen been studied? 
Kako je bilo zdravilo Dacogen raziskano?
How does Dacogen work? 
Kako zdravilo Dacogen deluje?
How is Dacogen used? 
Kako se zdravilo Dacogen uporablja?
Dacogen can only be obtained with a prescription. 
Predpisovanje in izdaja zdravila je le na recept.
Previously known as Zenas. 
Prej znano kot Zenas.
It is available as tablets (10 mg). 
Na voljo je v obliki tablet (10 mg).
The name of the medicine was changed to Firdapse on 28 January 2010. 
Ime zdravila je bilo 28. januarja 2010 spremenjeno v Firdapse.
This means that because the disease is rare, it has not been possible to obtain complete information about Firdapse. 
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o njem.
Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary. 
Evropska agencija za zdravila bo vsako leto pregledala vse nove podatke, ki bodo na voljo, in posodobila ta povzetek, če bo to potrebno.
What measures are being taken to ensure the safe and effective use of Firdapse? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Firdapse?
The European Commission granted a marketing authorisation valid throughout the EU for Zenas on 23 December 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Zenas, veljavno po vsej Evropski uniji, izdala 23. decembra 2009.
The recommended starting dose of Firdapse is 15 mg per day, which can be increased by 5 mg every four to five days up to a maximum of 60 mg per day. 
Priporočeni začetni odmerek zdravila Firdapse je 15 mg na dan, ki se lahko povečuje po 5 mg vsake štiri do pet dni do največ 60 mg na dan.
It must also not be used with medicines that have a narrow therapeutic window. 
Prav tako se ne sme uporabljati z zdravili z ozkim terapevtskim oknom.
Other information about Firdapse 
Druge informacije o zdravilu Firdapse
This document is a summary of the European public assessment report (EPAR) for Firdapse. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Firdapse.
A risk management plan has been developed to ensure that Firdapse is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Firdapse je bil pripravljen načrt obvladovanja tveganj.
Another study combined data from the two published studies and looked at compound muscle action potential (CMAP). 
V drugi študiji so združili podatke iz dveh objavljenih študij in preverili sestavljeni mišični akcijski potencial (CMAP).
The company will ensure that all healthcare professionals who are expected to use the medicine are provided with information on how to enter their patients in the registry. 
Zagotovila bo, da bodo vsi zdravstveni delavci, ki bodo uporabljali zdravilo, prejeli informacije o načinu vnašanja njihovih bolnikov v register.
The company that makes Firdapse will provide further data from studies on cancer in experimental models. 
Družba, ki proizvaja zdravilo Firdapse bo predložila dodatne podatke iz študij raka na poskusnih modelih.
For more information about treatment with Firdapse, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Firdapse preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is the risk associated with Firdapse? 
Kakšna tveganja so povezana z zdravilom Firdapse?
A medicine with a narrow therapeutic window can easily cause side effects if given at a dose a little higher than the recommended dose. 
Zdravilo z ozkim terapevtskim oknom lahko v odmerku, nekoliko višjem od priporočenega, zlahka povzroči neželene učinke.
The summary of the opinion of the Committee for Orphan Medicinal Products for Firdapse can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Firdapse je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Firdapse is taken in divided doses, three or four times a day, and a single dose should not be more than 20 mg. Firdapse should be taken with food. 
Jemlje se v ločenih odmerkih tri ali štiri krat dnevno, posamezni odmerek pa ne sme preseči 20 mg.
What benefit has Firdapse shown during the studies? 
Kakšne koristi je zdravilo Firdapse izkazalo med študijami?
Firdapse is a medicine that contains the active substance amifampridine. 
Firdapse je zdravilo, ki vsebuje zdravilno učinkovino amifampridin.
Because amifampridine-containing medicines have been used in the European Union (EU) for over 20 years, the company presented the results of studies from the scientific literature on amifampridine to support the use of Firdapse. 
Ker se zdravila z zdravilno učinkovino amifampridin v Evropski uniji uporabljajo že več kot dvajset let, je družba v podporo uporabi zdravila Firdapse predstavila rezultate študij o amifampridinu iz znanstvene literature.
It must not be used with sultopride (an antipsychotic medicine), or medicines known to cause QTc prolongation (an alteration of the electrical activity of the heart). 
Ne sme se uporabljati s sultopridom (antipsihotičnim zdravilom) ali z zdravili, ki povzročajo podaljšanje QTc (spremembe električne aktivnosti srca).
Firdapse has been authorised under ‘exceptional circumstances'. 
Zdravilo Firdapse je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Firdapse. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Firdapse, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Firdapse in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Acetylcholine is released from the nerve endings during a period of ‘depolarisation'. 
Acetilholin se iz živčnih končičev sprošča v fazi „depolarizacije“.
The most common side effects reported with Firdapse are paraesthesia (unusual sensations like pins and needles) and gastro-intestinal disorders such as epigastralgia (pain around the upper part of the stomach), diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache). 
Najpogostejši neželeni učinki, o katerih so poročali pri uporabi zdravila Firdapse, so parestezija (nenavadni občutki zbadanja) in prebavne motnje, kot so epigastralgija (bolečina v zgornjem delu želodca), driska, navzeja (slabost) in bolečine v trebuhu.
Additionally, the effect of Firdapse on the QT interval (the electrical activity of the heart) was investigated. 
Poleg tega so proučevali učinek zdravila Firdapse na interval QT (električna aktivnost srca).
The full EPAR for Firdapse can be found 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 Firdapse je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Firdapse must not be used in patients who have epilepsy or in patients with uncontrolled asthma or congenital QT syndromes (disruption of the heartbeat). 
Zdravila Firdapse ne smejo uporabljati bolniki z epilepsijo, ali bolniki z neobvladovano astmo oziroma kongenitalnimi sindromi QT (motnjami srčnega ritma).
For the full list of all side effects and restrictions with Firdapse, see the package leaflet. 
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Firdapse glejte navodilo za uporabo.
Because the number of patients with LEMS is low, the disease is considered ‘rare', and Firdapse was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 December 2002. 
Ker je bolnikov z Lambert-Eatonovim miastenijskim sindromom malo, velja ta bolezen za redko, zato je bilo zdravilo Firdapse dne 18. decembra 2002 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
In the QT study, amifampridine was observed to have no effects on the activity of the heart, as shown by the electrocardiograms of healthy volunteers taking part in this study. 
V študiji vpliva na električno aktivnost srca so ugotovili, da amifampridin ne vpliva na dejavnost srca, kar so v okviru te študije dokazali z elektrokardiogrami zdravih prostovoljcev.
Why has Firdapse been approved? 
Zakaj je bilo zdravilo Firdapse odobreno?
What information is still awaited for Firdapse? 
Katere informacije o zdravilu Firdapse še pričakujemo?
The active substance in Firdapse, amifampridine, is a potassium channel blocker, which prevents charged potassium particles from leaving the nerve cells. 
Zdravilna učinkovina zdravila Firdapse, amifampridin, je zaviralec kalijevih kanalčkov, ki preprečuje potovanje nabitih kalijevih delcev iz živčnih celic.
The CHMP decided that Firdapse'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 Firdapse večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The main measures of effectiveness were based on the rating of how well the muscles worked using a scoring system, either the neurological disability score (NDS) or the quantitative myasthenia gravis (QMG) score. 
Glavna merila učinkovitosti so temeljila na merjenju učinkovitosti delovanja mišic po točkovnem sistemu: oceni nevrološke okvare ali kvantitativni oceni miastenije gravis.
In two published studies involving a total of 38 adults with LEMS, amifampridine was compared with placebo (a dummy treatment). 
V dveh objavljenih študijah, v kateri je bilo vključenih 38 odraslih z Lambert-Eatonovim miastenijskim sindromom, so amifampridin primerjali s placebom (zdravilom brez zdravilne učinkovine).
How has Firdapse been studied? 
Kako je bilo zdravilo Firdapse raziskano?
This prolongs the period of depolarisation, allowing more time for the nerves to release acetylcholine and so stimulate the muscles to contract. 
Zato se faza depolarizacije podaljša in se lahko acetilholin dlje sprošča iz živcev ter tako spodbuja krčenje mišic.
In one study, the NDS was reduced from 40 to 22 points in patients taking Firdapse compared with a drop to 35 points in patients taking placebo. 
V eni študiji se je pri bolnikih, ki so jemali zdravilo Firdapse, ocena nevrološke okvare znižala s 40 na 22 točk, pri bolnikih, ki so jemali placebo, pa na 35 točk.
For muscles to contract, nerves have to transmit electrical impulses to the muscles through a chemical messenger called acetylcholine. 
Da se mišice krčijo, morajo živci prek kemijskega prenašalca, imenovanega acetilholin, do njih prenesti električne impulze.
LEMS is a disease in which patients have muscle weakness because of a failure of the nerves to transmit electrical impulses to the muscles. 
To je bolezen, ki se kaže z mišično šibkostjo, ki nastane zaradi motnje prenosa električnih impulzov po živcih do mišic.
Firdapse is used to treat the symptoms of Lambert-Eaton myasthenic syndrome (LEMS) in adults. 
Zdravilo Firdapse se uporablja za zdravljenje odraslih s simptomi Lambert-Eatonovega miastenijskega sindroma (LEMS).
In the third combined study, patients taking Firdapse had better improvements in CMAP than patients taking placebo. 
V tretji kombinirani študiji se je sestavljeni mišični akcijski potencial pri bolnikih, ki so jemali zdravilo Firdapse, izboljšal bolj kot pri bolnikih, ki so jemali placebo.
What is Firdapse used for? 
Za kaj se zdravilo Firdapse uporablja?
CMAP is a measure of electrical activity in muscles. 
Sestavljeni mišični akcijski potencial je merilo električne aktivnosti mišic.
Firdapse was more effective than placebo at treating patients with LEMS. 
Zdravilo Firdapse je bilo učinkovitejše od placeba pri zdravljenju bolnikov z Lambert-Eatonovim miastenijskim sindromom.
Treatment with Firdapse should only be started under the supervision of a doctor experienced in treating LEMS. 
Zdravljenje z zdravilom Firdapse se lahko uvede le pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem Lambert-Eatonovega miastenijskega sindroma.
Patients with lower NDS or QMG scores have better muscle function. 
Pri bolnikih z nižjo oceno nevrološke okvare ali nižjo kvantitativno oceno miastenije gravis mišice delujejo bolje.
The other study showed a reduction in the QMG score of 2 points in patients taking Firdapse compared with a rise of 0.25 points in patients taking placebo. 
V drugi študiji se je pri bolnikih, ki so jemali zdravilo Firdapse, kvantitativna ocena miastenije gravis znižala za 2 točki, medtem ko se je pri bolnikih, ki so jemali placebo, zvišala za 0,25 točke.
Additionally, the company that markets Firdapse has been required to set up a patient registry for patients with LEMS. 
Poleg tega mora družba, ki trži zdravilo Firdapse, pripraviti register bolnikov z Lambert-Eatonovim miastenijskim sindromom.
How is Firdapse used? 
Kako se zdravilo Firdapse uporablja?
What is Firdapse? 
Kaj je zdravilo Firdapse?
How does Firdapse work? 
Kako zdravilo Firdapse deluje?
Date of first authorisation: 29 November 2010 Date of latest renewal: 17 July 2015 
Datum prve odobritve: 29. november 2010 Datum zadnjega podaljšanja: 17. julij 2015
Some effects mentioned under section 4. 
Nekateri učinki, navedeni v poglavju 4.