FrancophonIA/ELRC3.0 huggingface dataset:
English: Gilenya must also not be used in patients with certain diseases affecting the heart and blood vessels or in those who have had such diseases or problems with the blood supply to the brain.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih z določenimi boleznimi, ki vplivajo na srce in krvne žile, ali pri tistih, pri katerih so se v preteklosti pojavile tovrstne bolezni ali težave pri oskrbi možganov s krvjo.
English: What is Gilenya and what is it used for?
Slovenian: Kaj je zdravilo Gilenya in za kaj se uporablja?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gilenya have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Gilenya upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Three main studies in adults and one main study in children have found that Gilenya was more effective than placebo (a dummy treatment) or interferon beta-1a (another medicine for treating multiple sclerosis) in patients with relapsing-remitting multiple sclerosis.
Slovenian: V treh glavnih študijah pri odraslih in eni glavni študiji pri otrocih so ugotovili, da je bilo zdravilo Gilenya učinkovitejše od placeba (zdravila brez učinkovine) in interferona beta-1a (drugega zdravila za zdravljenje multiple skleroze) pri bolnikih z recidivno-remitentno multiplo sklerozo.
English: The company that markets Gilenya will provide results from a study to assess the risk of side effects on the heart and circulation.
Slovenian: Družba, ki trži zdravilo Gilenya, bo izvedla študijo za oceno tveganja neželenih učinkov na srce in krvni obtok.
English: Gilenya can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in multiple sclerosis.
Slovenian: Predpisovanje in izdaja zdravila Gilenya je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem multiple skleroze.
English: Gilenya is used when the disease remains active despite appropriate treatment with at least one other disease-modifying therapy, or is severe and getting worse rapidly.
Slovenian: Zdravilo Gilenya se uporablja, kadar bolezen ostane aktivna kljub ustreznem zdravljenju z vsaj enim drugim zdravilom za spreminjanje poteka bolezni oziroma je zelo huda in se hitro poslabšuje.
English: The most common side effects with Gilenya (seen in more than 1 patient in 10) are flu, sinusitis (inflammation of the sinuses), headache, cough, diarrhoea, back pain and raised liver enzyme levels (a sign of liver problems).
Slovenian: Najpogostejši neželeni učinki zdravila Gilenya (ki se lahko pojavijo pri več kot 1 bolniku od 10) so gripa, sinuzitis (vnetje sinusov), glavobol, kašelj, driska, bolečine v hrbtu in povišana raven jetrnih encimov (znak težav z jetri).
English: Of patients given Gilenya, 14% (15 out of 107) experienced relapses compared with 54% (58 out of 107) of patients given interferon beta-1a.
Slovenian: Recidivi so se pojavili pri 14 % (15 od 107) bolnikov, ki so prejemali zdravilo Gilenya, v primerjavi s 54 % (58 od 107) bolnikov, ki so prejemali interferon beta-1a.
English: The most serious side effects are infections, macular oedema (swelling in the central part of the retina at the back of the eye) and atrioventricular block (a type of heart rhythm disorder) at the start of treatment.
Slovenian: Najresnejši neželeni učinki so okužbe, makularni edem (otekanje osrednjega dela mrežnice v zadnjem delu očesa) in preddvorno-prekatna blokada (vrsta motnje srčnega ritma) ob začetku zdravljenja.
English: Women should not become pregnant while taking Gilenya and for two months after treatment has stopped.
Slovenian: Ženske se morajo med zdravljenjem z zdravilom Gilenya in dva meseca po zdravljenju izogibati zanositvi.
English: However, because of possible side effects, the Agency concluded that Gilenya should only be used in patients who have a real need for the medicine either because their disease has not improved with at least one other disease-modifying therapy or because it is severe and getting worse rapidly.
Slovenian: Vendar je zaradi možnih neželenih učinkov zdravila Gilenya sklenila, da se lahko uporablja samo pri bolnikih, ki zdravilo resnično potrebujejo, ker se niso odzvali na vsaj eno drugo zdravljenje z zdravilom za spreminjanje poteka bolezni ali je njihova bolezen huda in se hitro poslabšuje.
English: The active substance in Gilenya, fingolimod, prevents T cells (a type of white blood cell involved in the immune system) travelling from the lymph nodes towards the brain and spinal cord, thus limiting the damage they cause in multiple sclerosis.
Slovenian: Učinkovina v zdravilu Gilenya, fingolimod, zmanjšuje sposobnost premikanja celic T (vrste belih krvnih celic, ki so del imunskega sistema) iz bezgavk do možganov in hrbtenjače ter tako omejuje škodo, ki jo te celice povzročijo pri multipli sklerozi.
English: Because Gilenya decreases the heart rate and can affect the heart's electrical activity and rhythm, the patient's blood pressure and heart activity is checked before starting treatment and during treatment, and also if Gilenya treatment is restarted after an interruption.
Slovenian: Ker zdravilo Gilenya upočasnjuje srčni utrip ter lahko vpliva na električno dejavnost in ritem srca, je pred in med zdravljenjem treba pri bolniku preveriti krvni tlak in delovanje srca.
English: The checklist includes information on the tests and monitoring in patients before and during treatment with Gilenya.
Slovenian: Na seznamu bodo navedene tudi informacije o testiranju in spremljanju bolnikov, ki ju je treba izvajati pred in začetkom zdravljenja z zdravilom Gilenya in po njem ter po ponovni uvedbi zdravljenja z njim.
English: In two studies involving a total of 2,355 patients, Gilenya was compared with placebo over two years.
Slovenian: V dveh študijah, v kateri je bilo vključenih 2 355 bolnikov, so v dveletnem obdobju zdravilo Gilenya primerjali s placebom.
English: How is Gilenya used?
Slovenian: Kako se zdravilo Gilenya uporablja?
English: How does Gilenya work?
Slovenian: Kako zdravilo Gilenya deluje?
English: For the full list of side effects of Gilenya, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Gilenya, glejte navodilo za uporabo.
English: In a third study involving 1,292 patients, Gilenya was compared with interferon beta-1a over one year.
Slovenian: V tretji študiji, ki je vključevala 1 292 bolnikov, so v enoletnem obdobju zdravilo Gilenya primerjali z interferonom beta-1a.
English: In a study involving 215 children, Gilenya was compared with interferon beta-1a for up to 2 years.
Slovenian: V študiji, ki je vključevala 215 otrok, so zdravilo Gilenya do dve leti primerjali z interferonom beta-1a.
English: Patients receiving Gilenya had around half the number of relapses compared with patients given interferon beta-1a.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Gilenya, je bilo v primerjavi s tistimi, ki so prejemali interferon beta-1a, približno polovico manj recidivov.
English: Patients treated with Gilenya had around half the number of relapses compared with patients given placebo.
Slovenian: V primerjavi z bolniki, ki so prejemali placebo, je bilo pri tistih, ki so prejemali zdravilo Gilenya, približno polovico manj recidivov.
English: The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Slovenian: Končna stopnja postopka pregleda je pravno zavezujoč sklep, ki ga sprejme Evropska komisija in je veljaven v vseh državah članicah EU.
English: 9 February 2018 EMA/152535/2018 - Corr. 1
Slovenian: 9. februar 2018 EMA/76828/2018
English: Healthcare professionals prescribing Esmya in the EU will receive a letter with further details.
Slovenian: Zdravstveni delavci, ki predpisujejo zdravilo Esmya v EU, bodo prejeli dopis z dodatnimi podrobnostmi.
English: If the tests indicate that you have a liver problem, your treatment will be stopped.
Slovenian: Če preiskave pokažejo, da imate težave z jetri, bo zdravljenje prekinjeno.
English: • As a precaution, while taking Esmya you will be required to have blood tests to check that your liver is working well.
Slovenian: • Kot previdnostni ukrep pri jemanju zdravila Esmya boste morali opraviti krvne preiskave, s katerimi bodo preverili, ali vaša jetra dobro delujejo.
English: • Advise your patients about the signs and symptoms of liver injury.
Slovenian: • Bolnice opozorite o znakih in simptomih okvare jeter.
English: • 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.
Slovenian: • 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.
English: 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.
Slovenian: 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.
English: These recommendations are temporary measures to protect patients' health, pending the conclusion of the review of Esmya which started on 30 November 2017.
Slovenian: Ta priporočila so začasni ukrep za zaščito zdravja bolnic do zaključka pregleda zdravila Esmya, ki se je začel 30. novembra 2017.
English: Information for patients
Slovenian: Informacije za bolnice
English: 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.
Slovenian: Pri nekaterih ženskah se uporablja do tri mesece pred kirurškim posegom za odstranitev leiomiomov, pri drugih pa za dolgoročno zdravljenje s prekinitvami.
English: • 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.
Slovenian: • 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.
English: • 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.
Slovenian: • 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.
English: All women taking Esmya should have a liver function test at least once a month during treatment.
Slovenian: Vse ženske, ki jemljejo zdravilo Esmya, morajo med zdravljenjem vsaj enkrat na mesec opraviti preiskavo delovanja jeter.
English: • If your treatment is stopped, your doctor will check how well your liver is working 2 to 4 weeks after you stop taking Esmya.
Slovenian: • V primeru prekinitve zdravljenja bo zdravnik preveril delovanje vaših jeter dva do štiri tedne po prenehanju jemanja zdravila Esmya.
English: Following reports of liver injury and hepatic failure with Esmya, EMA has made the following temporary recommendations:
Slovenian: Zaradi poročil o okvarah jeter in jetrne odpovedi pri jemanju zdravila Esmya je agencija EMA podala naslednja začasna priporočila:
English: On 8 February 2018, while the review was ongoing, the PRAC issue temporary recommendations.
Slovenian: Odbor je 8. februarja 2018 med postopkom pregleda izdal začasna priporočila.
English: No new patients should start treatment for the time being
Slovenian: Do nadaljnjega ne bi smeli uvajati zdravljenja pri novih bolnicah
English: Liver test should be repeated 2 to 4 weeks after stopping treatment.
Slovenian: Jetrne preiskave je treba ponoviti dva do štiri tedne po prekinitvi zdravljenja.
English: 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.
Slovenian: 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.
English: • Perform liver function tests at least once a month for all patients taking Esmya.
Slovenian: • Vsaj enkrat na mesec opravite preiskavo delovanja jeter pri vseh bolnicah, ki jemljejo zdravilo Esmya.
English: 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.
Slovenian: 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.
English: Ulipristal acetate is also the active substance of a single-dose medicine authorised for emergency contraception, ellaOne.
Slovenian: Ulipristalacetat je zdravilna učinkovina tudi v enoodmernem zdravilu ellaOne, odobrenem za nujno kontracepcijo.
English: • Do not start new patients on Esmya or new treatment courses in patients who have already completed a previous one.
Slovenian: • Ne uvajajte zdravljenja z zdravilom Esmya pri novih bolnicah in ne začenjajte novega cikla zdravljenja pri bolnicah, ki so že zaključile prvi cikel.
English: 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.
Slovenian: Zdravilo Esmya je bilo leta 2012 odobreno za zdravljenje zmernih do hudih simptomov materničnih leiomiomov, tj. nerakavih (benignih) tumorjev maternice pri ženskah pred menopavzo.
English: A link between Esmya and cases of serious liver injury is under review.
Slovenian: Predmet pregleda je povezava med zdravilom Esmya in primeri hude jetrne okvare.
English: 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.
Slovenian: 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.
English: • Esmya, used to treat uterine fibroids, is being reviewed because cases of serious liver problems have occurred in women taking the medicine.
Slovenian: • 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.
English: 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.
Slovenian: Če preiskava pokaže nepravilnosti (ravni jetrnih encimov višje od dvakratnika zgornje meje normalnega razpona), mora zdravstveni delavec prekiniti zdravljenje in pozorno spremljati bolnico.
English: As a temporary measure while the review is ongoing, the PRAC has recommended regular liver monitoring for women taking Esmya for uterine fibroids.
Slovenian: Odbor je kot začasni ukrep, medtem ko poteka pregled, priporočil redno spremljanje delovanja jeter pri ženskah, ki jemljejo zdravilo Esmya zaradi pojava materničnih leiomiomov.
English: These recommendations are temporary measures, pending the conclusion of an ongoing EMA review of Esmya.
Slovenian: Ta priporočila so začasni ukrep do zaključka pregleda zdravila Esmya pri agenciji.
English: If transaminase levels are more than 2 times the upper limit of normal, stop treatment and closely monitor the patient.
Slovenian: Če so ravni aminotransferaz višje od dvakratnika zgornje meje normalnega razpona, prekinite zdravljenje in bolnico pozorno spremljate.
English: If the patient develops transaminase levels more than 2 times the upper limit of normal, stop treatment and monitor the patient closely.
Slovenian: Če pri bolnici ugotovite ravni aminotransferaz, ki so višje od dvakratnika zgornje meje normalnega razpona, prekinite zdravljenje in bolnico pozorno spremljate.
English: This summary was last updated in 05-2013.
Slovenian: Ta povzetek je bil nazadnje posodobljen 05-2013.
English: Olanzapine has been authorised in the European Union (EU) since 1996.
Slovenian: Olanzapin je v Evropski uniji (EU) odobren od leta 1996.
English: Zypadhera olanzapine
Slovenian: Zypadhera olanzapin
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zypadhera on 19 November 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zypadhera, veljavno po vsej Evropski uniji, odobrila dne 19. novembra 2008.
English: Olanzapine attaches to several different receptors on the surface of nerve cells in the brain.
Slovenian: Olanzapin se veže na več različnih receptorjev na površju živčnih celic v možganih.
English: The full EPAR for Zypadhera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Symptoms of overdose include sedation (sleepiness) and delirium (confusion).
Slovenian: Simptomi prekomernega odmerka vključujejo sedacijo (zaspanost) in delirij (zmedenost).
English: 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.
Slovenian: Glavni merili učinkovitosti sta bila čas, potreben za poslabšanje simptomov, in število bolnikov, katerih simptomi so se poslabšali v 24 tednih.
English: 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.
Slovenian: Bolnike je treba pozorno nadzorovati zaradi znakov relapsa (ponovnega pojava simptomov) med prvim mesecem do dveh mesecev zdravljenja in po potrebi prilagoditi odmerek.
English: 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.
Slovenian: 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.
English: Since these neurotransmitters are involved in schizophrenia, olanzapine helps to normalise the activity of the brain, reducing the symptoms of the disease.
Slovenian: Ker ti živčni prenašalci sodelujejo pri shizofreniji, olanzapin pomaga normalizirati dejavnost možganov in oslabi simptome bolezni.
English: Zypadhera is given at doses of 150, 210 or 300 mg every two weeks, or 300 or 405 mg every four weeks.
Slovenian: Zdravilo Zypadhera se daje v odmerku 150, 210 ali 300 mg vsaka dva tedna oziroma v odmerku 300 ali 405 mg vsake štiri tedne.
English: This is a summary of the European public assessment report (EPAR) for Zypadhera.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zypadhera.
English: Patients who have symptoms of overdose should continue to be monitored until the symptoms have passed.
Slovenian: Bolnike s simptomi prekomernega odmerka je treba nadzorovati še naprej, dokler simptomi ne izginejo.
English: The main measure of effectiveness was the change in symptoms measured on a standard scale for schizophrenia after eight weeks;
Slovenian: Glavno merilo učinkovitosti so bile spremembe v simptomih, ki so jih merili s standardno lestvico shizofrenije po osmih tednih;
English: Zypadhera is not recommended for patients over 65 years of age.
Slovenian: Uporaba zdravila Zypadhera ni priporočljiva pri bolnikih, starejših od 65 let.
English: 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).
Slovenian: 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).
English: For more information about treatment with Zypadhera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: 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.
English: It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine.
Slovenian: Domneva se, da so koristni učinki olanzapina posledica zaviranja receptorjev za živčna prenašalca 5hidroksitripamin (imenovanega tudi serotonin) in dopamin.
English: Which measures are being taken to ensure the safe use of Zypadhera?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Zypadhera ?
English: Zypadhera must not be injected into a vein or under the skin.
Slovenian: Zdravilo Zypadhera se ne sme vbrizgati v veno ali pod kožo.
English: It is available as tablets, orodispersible tablets (tablets that dissolve in the mouth) and rapidly acting injections in Zyprexa, Zyprexa Velotab and other medicines.
Slovenian: 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.
English: 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.
Slovenian: Ker je olanzapin v EU že odobren kot zdravilo Zyprexa, je družba v podporo uporabi zdravila Zypadhera uporabila nekatere podatke o tem zdravilu.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.