natgillin/translations-raw huggingface dataset:
9 February 2018 EMA/152535/2018 - Corr. 1 
9. februar 2018 EMA/76828/2018
Healthcare professionals prescribing Esmya in the EU will receive a letter with further details. 
Zdravstveni delavci, ki predpisujejo zdravilo Esmya v EU, bodo prejeli dopis z dodatnimi podrobnostmi.
If the tests indicate that you have a liver problem, your treatment will be stopped. 
Če preiskave pokažejo, da imate težave z jetri, bo zdravljenje prekinjeno.
• As a precaution, while taking Esmya you will be required to have blood tests to check that your liver is working well. 
• Kot previdnostni ukrep pri jemanju zdravila Esmya boste morali opraviti krvne preiskave, s katerimi bodo preverili, ali vaša jetra dobro delujejo.
• Advise your patients about the signs and symptoms of liver injury. 
• Bolnice opozorite o znakih in simptomih okvare jeter.
• If you have nausea (feeling sick), vomiting, upper belly pain, lack of appetite, tiredness or yellowing of the eyes or skin, contact your doctor immediately as these could be signs of liver problems. 
• Če se pri vas pojavi siljenje na bruhanje (navzeja), bruhanje, bolečine v zgornjem predelu trebuha, pomanjkanje teka, utrujenost ali porumenelost oči ali kože, se nemudoma posvetujte z zdravnikom, ker so to lahko znaki težav z jetri.
The PRAC's final recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt an opinion. 
Končna priporočila tega odbora bodo poslana Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za vprašanja glede zdravil za uporabo v humani medicini, ki bo sprejel končno mnenje.
These recommendations are temporary measures to protect patients' health, pending the conclusion of the review of Esmya which started on 30 November 2017. 
Ta priporočila so začasni ukrep za zaščito zdravja bolnic do zaključka pregleda zdravila Esmya, ki se je začel 30. novembra 2017.
Information for patients 
Informacije za bolnice
It is used for up to 3 months before women undergo surgery to remove the fibroids and can also be used long-term but with treatment breaks in other women. 
Pri nekaterih ženskah se uporablja do tri mesece pred kirurškim posegom za odstranitev leiomiomov, pri drugih pa za dolgoročno zdravljenje s prekinitvami.
• If you were about to start treatment with Esmya or start a new course of treatment, your doctor will put your treatment on hold until EMA's review of the medicine is complete. 
• Če je bilo predvideno, da boste začeli zdravljenje z zdravilom Esmya ali da boste začeli nov cikel zdravljenja s tem zdravilom, bo vaš zdravnik njegov začetek odložil, dokler postopek pregleda zdravila pri agenciji ne bo zaključen.
• For any patient with signs or symptoms consistent with liver injury (such as nausea, vomiting, right hypochondrial pain, anorexia, asthenia, jaundice), check transaminase levels immediately. 
• Pri bolnicah z znaki ali simptomi, ki kažejo na okvaro jeter (kot so navzeja, bruhanje, bolečina v desnem hipohondriju, anoreksija, astenija, zlatenica), nemudoma preverite ravni aminotransferaz.
All women taking Esmya should have a liver function test at least once a month during treatment. 
Vse ženske, ki jemljejo zdravilo Esmya, morajo med zdravljenjem vsaj enkrat na mesec opraviti preiskavo delovanja jeter.
• If your treatment is stopped, your doctor will check how well your liver is working 2 to 4 weeks after you stop taking Esmya. 
• V primeru prekinitve zdravljenja bo zdravnik preveril delovanje vaših jeter dva do štiri tedne po prenehanju jemanja zdravila Esmya.
Following reports of liver injury and hepatic failure with Esmya, EMA has made the following temporary recommendations: 
Zaradi poročil o okvarah jeter in jetrne odpovedi pri jemanju zdravila Esmya je agencija EMA podala naslednja začasna priporočila:
On 8 February 2018, while the review was ongoing, the PRAC issue temporary recommendations. 
Odbor je 8. februarja 2018 med postopkom pregleda izdal začasna priporočila.
No new patients should start treatment for the time being 
Do nadaljnjega ne bi smeli uvajati zdravljenja pri novih bolnicah
Liver test should be repeated 2 to 4 weeks after stopping treatment. 
Jetrne preiskave je treba ponoviti dva do štiri tedne po prekinitvi zdravljenja.
The PRAC is also recommending that no new patients should be started on Esmya and no patients who have completed a course of treatment should start another one for the time being. 
Odbor prav tako priporoča, da se do nadaljnjega zdravilo Esmya ne uvede pri nobeni novi bolnici in da nobena bolnica, ki je že zaključila zdravljenje, ne sme začeti novega.
• Perform liver function tests at least once a month for all patients taking Esmya. 
• Vsaj enkrat na mesec opravite preiskavo delovanja jeter pri vseh bolnicah, ki jemljejo zdravilo Esmya.
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is currently reviewing the benefits and risks with Esmya, following reports of serious liver injury, including liver failure leading to transplantation. 
Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC) pri agenciji trenutno proučuje koristi in tveganja zdravila Esmya zaradi poročil o resnih okvarah jeter, vključno z odpovedjo jeter, ki je privedla do presaditve.
Ulipristal acetate is also the active substance of a single-dose medicine authorised for emergency contraception, ellaOne. 
Ulipristalacetat je zdravilna učinkovina tudi v enoodmernem zdravilu ellaOne, odobrenem za nujno kontracepcijo.
• Do not start new patients on Esmya or new treatment courses in patients who have already completed a previous one. 
• Ne uvajajte zdravljenja z zdravilom Esmya pri novih bolnicah in ne začenjajte novega cikla zdravljenja pri bolnicah, ki so že zaključile prvi cikel.
Esmya was authorised in the EU in 2012 for the treatment of moderate to severe symptoms of uterine fibroids, which are non-cancerous (benign) tumours of the womb, in women who have not reached the menopause. 
Zdravilo Esmya je bilo leta 2012 odobreno za zdravljenje zmernih do hudih simptomov materničnih leiomiomov, tj. nerakavih (benignih) tumorjev maternice pri ženskah pred menopavzo.
A link between Esmya and cases of serious liver injury is under review. 
Predmet pregleda je povezava med zdravilom Esmya in primeri hude jetrne okvare.
The active substance in Esmya, ulipristal acetate, works by attaching to the targets on cells (receptors) that the hormone progesterone normally attaches to, preventing progesterone from having its effect. 
Zdravilna učinkovina v zdravilu Esmya, ulipristalacetat, deluje tako, da se na celicah veže na običajna prijemališča (receptorje) za vezavo hormona progesterona, kar prepreči učinek progesterona.
• Esmya, used to treat uterine fibroids, is being reviewed because cases of serious liver problems have occurred in women taking the medicine. 
• Zdravilo Esmya, ki se uporablja za zdravljenje materničnih leiomiomov, je v postopku pregleda, ker so se pri ženskah, ki so jemale zdravilo, pojavile resne težave z jetri.
If the test is abnormal (liver enzyme levels more than 2 times the upper limit of normal), the healthcare professional should stop treatment and closely monitor the patient. 
Če preiskava pokaže nepravilnosti (ravni jetrnih encimov višje od dvakratnika zgornje meje normalnega razpona), mora zdravstveni delavec prekiniti zdravljenje in pozorno spremljati bolnico.
As a temporary measure while the review is ongoing, the PRAC has recommended regular liver monitoring for women taking Esmya for uterine fibroids. 
Odbor je kot začasni ukrep, medtem ko poteka pregled, priporočil redno spremljanje delovanja jeter pri ženskah, ki jemljejo zdravilo Esmya zaradi pojava materničnih leiomiomov.
These recommendations are temporary measures, pending the conclusion of an ongoing EMA review of Esmya. 
Ta priporočila so začasni ukrep do zaključka pregleda zdravila Esmya pri agenciji.
If transaminase levels are more than 2 times the upper limit of normal, stop treatment and closely monitor the patient. 
Če so ravni aminotransferaz višje od dvakratnika zgornje meje normalnega razpona, prekinite zdravljenje in bolnico pozorno spremljate.
If the patient develops transaminase levels more than 2 times the upper limit of normal, stop treatment and monitor the patient closely. 
Če pri bolnici ugotovite ravni aminotransferaz, ki so višje od dvakratnika zgornje meje normalnega razpona, prekinite zdravljenje in bolnico pozorno spremljate.
This summary was last updated in 05-2013. 
Ta povzetek je bil nazadnje posodobljen 05-2013.
Olanzapine has been authorised in the European Union (EU) since 1996. 
Olanzapin je v Evropski uniji (EU) odobren od leta 1996.
The European Commission granted a marketing authorisation valid throughout the European Union for Zypadhera on 19 November 2008. 
Evropska komisija je dovoljenje za promet z zdravilom Zypadhera, veljavno po vsej Evropski uniji, odobrila dne 19. novembra 2008.
Olanzapine attaches to several different receptors on the surface of nerve cells in the brain. 
Olanzapin se veže na več različnih receptorjev na površju živčnih celic v možganih.
The full EPAR for Zypadhera 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 Zypadhera je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
However, it noted that prolonged-release injections are not suitable for use as initial treatment, because the medicine takes at least a week to reduce symptoms and patients may need rapid control of symptoms. 
Vendar pa je ugotovil, da injekcije s podaljšanim izločanjem niso primerne kot začetno zdravljenje, ker zdravilo potrebuje vsaj en teden, da ublaži simptome, bolniki pa bi morda potrebovali hiter nadzor simptomov.
Symptoms of overdose include sedation (sleepiness) and delirium (confusion). 
Simptomi prekomernega odmerka vključujejo sedacijo (zaspanost) in delirij (zmedenost).
The main measures of effectiveness were the time taken for symptoms to get worse and the number of patients whose symptoms got worse over 24 weeks. 
Glavni merili učinkovitosti sta bila čas, potreben za poslabšanje simptomov, in število bolnikov, katerih simptomi so se poslabšali v 24 tednih.
Patients should be monitored closely for signs of relapse (a return of symptoms) during the first one to two months of treatment, and the dose adjusted if necessary. 
Bolnike je treba pozorno nadzorovati zaradi znakov relapsa (ponovnega pojava simptomov) med prvim mesecem do dveh mesecev zdravljenja in po potrebi prilagoditi odmerek.
The company that makes Zypadhera will provide an educational programme for doctors, nurses and pharmacists and a card for patients in all Member States, reminding them of how to use the medicine safely. 
Družba, ki izdeluje zdravilo Zypadhera, bo pripravila izobraževalni program za zdravnike, medicinske sestre in farmacevte ter brošuro za bolnike v vseh državah članicah in jih opomnila o varni uporabi zdravila.
Since these neurotransmitters are involved in schizophrenia, olanzapine helps to normalise the activity of the brain, reducing the symptoms of the disease. 
Ker ti živčni prenašalci sodelujejo pri shizofreniji, olanzapin pomaga normalizirati dejavnost možganov in oslabi simptome bolezni.
Zypadhera is given at doses of 150, 210 or 300 mg every two weeks, or 300 or 405 mg every four weeks. 
Zdravilo Zypadhera se daje v odmerku 150, 210 ali 300 mg vsaka dva tedna oziroma v odmerku 300 ali 405 mg vsake štiri tedne.
This is a summary of the European public assessment report (EPAR) for Zypadhera. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zypadhera.
Patients who have symptoms of overdose should continue to be monitored until the symptoms have passed. 
Bolnike s simptomi prekomernega odmerka je treba nadzorovati še naprej, dokler simptomi ne izginejo.
The main measure of effectiveness was the change in symptoms measured on a standard scale for schizophrenia after eight weeks; 
Glavno merilo učinkovitosti so bile spremembe v simptomih, ki so jih merili s standardno lestvico shizofrenije po osmih tednih;
Zypadhera is not recommended for patients over 65 years of age. 
Uporaba zdravila Zypadhera ni priporočljiva pri bolnikih, starejših od 65 let.
Three of the doses of Zypadhera were ‘high' (300 mg and 150 mg every two weeks, and 405 mg every four weeks) and one was ‘low' (45 mg every four weeks). 
Trije odmerki zdravila Zypadhera so bili „visoki“ (300 mg in 150 mg vsaka dva tedna ter 405 mg vsake štiri tedne), en pa je bil „nizek“ (45 mg vsake štiri tedne).
For more information about treatment with Zypadhera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Zypadhera preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine. 
Domneva se, da so koristni učinki olanzapina posledica zaviranja receptorjev za živčna prenašalca 5hidroksitripamin (imenovanega tudi serotonin) in dopamin.
Which measures are being taken to ensure the safe use of Zypadhera? 
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Zypadhera ?
Zypadhera must not be injected into a vein or under the skin. 
Zdravilo Zypadhera se ne sme vbrizgati v veno ali pod kožo.
It is available as tablets, orodispersible tablets (tablets that dissolve in the mouth) and rapidly acting injections in Zyprexa, Zyprexa Velotab and other medicines. 
Na voljo je v obliki tablet, orodisperzibilnih tablet (ki se raztopijo v ustih) in hitro delujočih injekcijskih brizg v zdravilu Zyprexa, Zyprexa Velotab ter drugih zdravilih.
Because olanzapine has already been authorised in the EU as Zyprexa, the company used some of the data from Zyprexa to support the use of Zypadhera. 
Ker je olanzapin v EU že odobren kot zdravilo Zyprexa, je družba v podporo uporabi zdravila Zypadhera uporabila nekatere podatke o tem zdravilu.
Symptom scores were around 100 points at the start of the study, but had fallen by around 25 points in the patients receiving Zypadhera after eight weeks, compared with around 9 points in the patients receiving placebo. 
Rezultati simptomov so bili približno 100 točk na začetku študije, vendar so se po osmih tednih zmanjšali za približno 25 točk pri bolnikih, ki so prejemali zdravilo Zypadhera, v primerjavi s približno devetimi točkami pri bolnikih, ki so prejemali placebo.
These will include information on what to do before and after each injection, the differences between Zypadhera and other injectable medicines containing olanzapine, and the recommendations on how patients should be monitored. 
Vsebovali bodo podatke o ukrepih pred vsakim vbrizganjem in po njem, razlikah med zdravilom Zypadhera ter drugimi zdravili, ki jih vbrizgamo in vsebujejo olanzapin, ter priporočila o spremljanju stanja bolnikov.
Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs). 
Shizofrenija je duševna bolezen s številnimi simptomi, kot so neorganizirano mišljenje in govor, halucinacije (prisluhi ali prividi), sumničavost ter blodnje (zmotna prepričanja).
However, patients aged between 65 and 75 years or patients with kidney or liver problems may use Zypadhera if an effective and welltolerated dose of oral olanzapine has been found. 
Kljub temu pa lahko bolniki, stari od 65 do 75 let, ali bolniki z ledvičnimi oziroma jetrnimi težavami zdravilo Zypadhera uporabljajo, če je bil ugotovljen odmerek peroralnega olanzapina, ki je učinkovit in ga bolniki dobro prenašajo.
Other information about Zypadhera 
Druge informacije o zdravilu Zypadhera
In addition, it is not possible to stop treatment after giving a prolonged-release injection, which would not be suitable for patients experiencing side effects. 
Poleg tega zdravljenja po uporabi injekcijske brizge s podaljšanim izločanjem ni mogoče zaustaviti, kar ne bi bilo primerno za bolnike, pri katerih se pojavijo neželeni učinki.
All of the patients in this study had been stabilised with other treatments for schizophrenia and had been taking olanzapine by mouth for at least six weeks before the study began. 
Vse bolnike v tej študiji so stabilizirali z drugimi vrstami zdravljenja shizofrenije, olanzapin pa so jemali peroralno vsaj šest tednov pred začetkom študije.
It is available as a powder and solvent that are made up into a prolonged-release suspension for injection. 
Na voljo je kot prašek in vehikel za pripravo suspenzijo za injiciranje s podaljšanim sproščanjem.
In the study looking at the maintenance of response to olanzapine treatment, Zypadhera was as effective as olanzapine taken by mouth: 10% of the patients receiving Zypadhera every two weeks had a worsening of symptoms, compared with 7% of those taking olanzapine by mouth. 
V študiji, s katero so opazovali vzdrževanje odziva na zdravljenje z olanzapinom, je bilo zdravilo Zypadhera enako učinkovito kot olanzapin, ki so ga bolniki jemali peroralno: pri 10 % bolnikov, ki so prejemali zdravilo Zypadhera vsake dva tedna, so se simptomi poslabšali, v primerjavi s 7 % tistih, ki so olanzapin jemali peroralno.
The ‘high' doses of Zypadhera were more effective at preventing a worsening of symptoms than the ‘low' dose. 
Visoki odmerki zdravila Zypadhera so bili bolj učinkoviti pri preprečevanju poslabšanja simptomov kot nizki odmerki.
Zypadhera has been studied in two main studies involving adults with schizophrenia. 
Zdravilo Zypadhera so raziskali v dveh glavnih študijah, ki sta vključevali odrasle bolnike s shizofrenijo.
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 Zypadhera. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Zypadhera, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The most common side effects with Zypadhera (seen in more than 1 patient in 10) are weight gain, somnolence (sleepiness), orthostatic hypotension (sudden drop in blood pressure on standing up) and raised levels of prolactin (a hormone). 
Najpogostejši neželeni učinki zdravila Zypadhera (opaženi pri več kot 1 od 10 bolnikov) so povečanje telesne mase, somnolenca (zaspanost), ortostatska hipotenzija (nenaden padec krvnega tlaka v stoječem položaju) in zvišane koncentracije prolaktina (hormona).
As a result, the active substance is released slowly for more than four weeks after injection of Zypadhera. 
Zato se zdravilna učinkovina v zdravilu sprošča počasi, dlje kot štiri tedne po vbrizganju zdravila Zypadhera.
The Committee decided that Zypadhera's benefits are greater than its risks and recommended that Zypadhera be given marketing authorisation. 
Odbor je zaključil, da so koristi zdravila Zypadhera večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
In the study of the initial treatment of schizophrenia, Zypadhera was more effective than placebo. 
V študiji začetnega zdravljenja shizofrenije je bilo zdravilo Zypadhera učinkovitejše od placeba.
What benefit has Zypadhera shown during the studies? 
Kakšne koristi je zdravilo Zypadhera izkazalo med študijami?
The effectiveness of Zypadhera was greater than placebo from the second week of treatment onwards. 
Učinkovitost zdravila Zypadhera je bila večja kot pri placebu od drugega tedna zdravljenja dalje.
Because patients should be monitored by qualified staff for these symptoms for at least three hours after injection, they should receive Zypadhera at a centre with the appropriate facilities to deal with a potential overdose. 
Ker mora za ugotavljanje pojava teh simptomov bolnike vsaj tri ure po vbrizganju nadzorovati usposobljeno osebje, morajo bolniki zdravilo Zypadhera prejeti v zdravstvenem zavodu, ki je primerno opremljen za ukrepanje ob morebitnem prekomernem odmerku.
The dose depends on the dose of olanzapine that the patient was previously taking by mouth. 
Odmerek je odvisen od odmerka olanzapina, ki ga je bolnik pred tem jemal peroralno.
In rare cases, patients receiving Zypadhera may experience symptoms of olanzapine overdose after injection if the medicine is accidentally injected into a vein. 
V redkih primerih se lahko pri bolnikih, ki prejemajo zdravilo Zypadhera, pojavijo simptomi prekomernega odmerka olanzapina po injekciji, če se zdravilo po nesreči vbrizga v veno.
Zypadhera is given by deep injection into the buttock muscle by a doctor or nurse who has been trained in giving this type of injection. 
Zdravilo Zypadhera dasta z globoko injekcijo v zadnjično mišico zdravnik ali sestra, ki sta usposobljena za tako injiciranje.
The CHMP noted that Zypadhera is effective both in the initial treatment of schizophrenia and in maintaining a response to treatment in schizophrenia. 
CHMP je zaključil, da je zdravilo Zypadhera učinkovito pri začetnem zdravljenju shizofrenije in vzdrževanju odziva na zdravljenje shizofrenije.
Zypadhera must not be used in patients who are hypersensitive (allergic) to olanzapine or any of the other ingredients. 
Zdravila Zypadhera ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) olanzapin ali katero koli drugo sestavino zdravila.
The first looked at the initial treatment of schizophrenia and the second looked at the maintenance of response to olanzapine treatment: 
V prvi študiji so opazovali začetno zdravljenje shizofrenije, v drugi pa vzdrževanje odziva na zdravljenje z olanzapinom:
For the full list of all side effects reported with Zypadhera, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zypadhera, glejte navodilo za uporabo.
Zypadhera is a medicine that contains the active substance olanzapine. 
Zypadhera je zdravilo, ki vsebuje zdravilno učinkovino olanzapin.
‘Prolonged release' means that the active substance is released slowly over a few weeks after being injected. 
Podaljšano sproščanje pomeni, da se zdravilna učinkovina po injiciranju sprošča nekaj tednov.
What is the risk associated with Zypadhera? 
Kakšna tveganja so povezana z zdravilom Zypadhera?
Zypadhera is used to maintain the improvement in symptoms in patients with schizophrenia who have already been stabilised on an initial course of olanzapine taken by mouth. 
Zdravilo Zypadhera se uporablja za vzdrževanje izboljšanja simptomov pri bolnikih s shizofrenijo, ki so že dosegli stabilno stanje v začetnemu zdravljenju z olanzapinom, vzetim peroralno.
• the study of initial treatment compared the effects of three doses of Zypadhera with those of placebo (dummy injections) in 404 patients. 
• v študiji začetnega zdravljenja so pri 404 bolnikih primerjali učinke treh odmerkov zdravila Zypadhera z učinki placeba (injekcijami zdravila brez zdravilne učinkovine).
A lower starting dose may be necessary in patients whose bodies may break olanzapine down slowly, such as those with moderate liver problems. 
Pri bolnikih, ki morda počasneje presnavljajo olanzapin, kot npr. tisti z zmernimi jetrnimi težavami, bo morda potreben nižji začetni odmerek.
Why has Zypadhera been approved? 
Zakaj je bilo zdravilo Zypadhera odobreno?
The active substance in Zypadhera, olanzapine, is an antipsychotic medicine. 
Zdravilna učinkovina zdravila Zypadhera je olanzapin, ki je antipsihotično zdravilo.
• the study of maintenance treatment compared the effects of four doses of Zypadhera with those of olanzapine taken by mouth in 1,065 patients. 
• v študiji vzdrževalnega zdravljenja pri 1 065 bolnikih so primerjali učinke štirih odmerkov zdravila Zypadhera z učinki peroralno zaužitega olanzapina.
The olanzapine in Zypadhera is presented as a ‘pamoate' salt, which makes the olanzapine less soluble. 
Olanzapin v zdravilu Zypadhera je v obliki soli pamoata, zaradi česar je manj topen.
What is Zypadhera used for? 
Za kaj se zdravilo Zypadhera uporablja?