FrancophonIA/ELRC3.0 huggingface dataset:
English: The study demonstrated a clinically and statistically significant relative risk reduction of 18% in the rate of the primary composite endpoint of cardiovascular mortality and hospitalisation for worsening heart failure (hazard ratio : 0.82, 95%CI [0.75;0.90] - p<0.0001) apparent within 3 months of initiation of treatment.
Slovenian: (razmerje tveganja: 0,82, 95 % interval zaupanja [0,75;0,90] - p<0,0001), vidnega po 3 mesecih po začetku zdravljenja.
English: Primary composite endpoint Components of the composite: - CV death - Hospitalisation for worsening HF
Slovenian: - srčno-žilna smrt - hospitalizacija zaradi poslabšanja srčnega popuščanja
English: The antianginal and anti-ischaemic efficacy of ivabradine was preserved in diabetic patients (n = 457) with a similar safety profile as compared to the overall population.
Slovenian: Antianginozni in antiishemični učinek ivabradina se je ohranjal pri bolnikih s sladkorno boleznijo
English: BATCH NUMBER Batch
Slovenian: ŠTEVILKA SERIJE Številka serije:
English: If heart rate increases persistently above 60 beats per minute at rest, the dose can be up titrated to the next upper dose in patients receiving 2.5 mg twice daily or 5 mg twice daily.
Slovenian: Če se srčna frekvenca med mirovanjem vztrajno povečuje nad 60 utripov na minuto, lahko odmerek titrirate navzgor do naslednjega večjega odmerka pri bolnikih, ki jemljejo 2,5 mg dvakrat na dan ali 5 mg dvakrat na dan. Zdravljenje morate prekiniti, če srčna frekvenca ostane pod 50 utripov na minuto ali simptomi bradikardije vztrajajo (glejte poglavje 4.4).
English: ibutilide, amiodarone).
Slovenian: Ivabradin je
English: Rash
Slovenian: ČET
English: Metabolism and nutrition disorders
Slovenian: Presnovne in prehranske motnje občasni hiperurikemija
English: and 45%), ivabradine did not have any deleterious influence on LVEF.
Slovenian: Poleg tega ivabradin ni imel klinično signifikantnega učinka na farmakokinetiko simvastatina,
English: Stroke
Slovenian: Odmerjanje
English: mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin).
Slovenian: ziprazidon, sertindol) - zdravila proti malariji (na primer meflokin ali halofantrin) - eritromicin v žilo (antibiotik) - pentamidin (zdravilo proti parazitom) - cisaprid (proti gastroezofagealnemu refluksu)
English: Special population
Slovenian: Posebne skupine bolnikov Starejši ljudje
English: This summary was last updated in 11-2011.
Slovenian: Povzetek je bil nazadnje posodobljen 11-2011.
English: It should not be poured or pumped directly into the mouth.
Slovenian: Raztopina se ne sme vliti ali načrpati neposredno v usta.
English: It is available as tablets (5 mg, 10 mg, 15 mg and 20 mg).
Slovenian: Na voljo je v obliki tablet (5 mg, 10 mg, 15 mg in 20 mg).
English: Axura should be given once a day, at the same time every day.
Slovenian: Zdravilo Axura se daje enkrat dnevno, vsak dan ob istem času.
English: If the solution is used, the dose should first be pumped onto a spoon or into a glass of water.
Slovenian: Če se uporablja raztopina, je treba odmerek najprej načrpati na žlico ali v kozarec vode.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Axura on 17 May 2002.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Axura, veljavno po vsej Evropski uniji, odobrila dne 17. maja 2002.
English: The full EPAR for Axura 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 Axura je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Alzheimer's disease is a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Slovenian: Alzheimerjeva bolezen je vrsta demence (možganske bolezni), ki postopoma prizadene spomin, intelektualno sposobnost in vedenje.
English: To prevent side effects, the dose of Axura is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Slovenian: Da se preprečijo neželeni učinki, se odmerek zdravila Axura v prvih treh tednih zdravljenja postopoma povečuje: prvi teden je odmerek 5 mg; drugi teden 10 mg, tretji teden pa 15 mg. Od četrtega tedna naprej je priporočeni vzdrževalni odmerek 20 mg enkrat dnevno.
English: In addition, overstimulation of the NMDA receptors can result in cell damage or death.
Slovenian: Poleg tega lahko prekomerna stimulacija receptorjev NMDA povzroči poškodbo ali odmiranje celic.
English: The first study involved 252 patients with moderately severe to severe disease, while the other two involved a total of 873 patients with mild to moderate disease.
Slovenian: Prva študija je vključevala 252 bolnikov z zmerno hudo do hudo boleznijo, drugi dve pa skupno 873 bolnikov z blago do zmerno boleznijo.
English: The main measures of effectiveness were the change in symptoms in three main areas: functional (the degree of disability), cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
Slovenian: Glavno merilo učinkovitosti je bila sprememba simptomov na treh glavnih področjih: funkcionalnem (stopnja invalidnosti), kognitivnem (sposobnost mišljenja, učenja in pomnjenja) in globalnem (kombinacija več področij, vključno s splošno funkcijo, kognitivnimi simptomi, vedenjem in sposobnostjo izvajanja vsakodnevnih dejavnosti).
English: For more information about treatment with Axura, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Axura preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: Other information about Axura
Slovenian: Druge informacije o zdravilu Axura
English: This is a summary of the European public assessment report (EPAR) for Axura.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Axura.
English: The most common side effects with Axura (seen in between 1 and 10 patients in 100) are somnolence (sleepiness), dizziness, hypertension (high blood pressure), dyspnoea (difficulty breathing), constipation, headache and drug hypersensitivity (allergy to the medicine).
Slovenian: Najpogostejši neželeni učinki zdravila Axura (opaženi pri 1 do 10 bolnikih izmed 100) so somnolenca (zaspanost), omotica, hipertenzija (visok krvni tlak), dispneja (oteženo dihanje), zaprtje, glavobol in preobčutljivost (alergija na zdravilo).
English: However, when these results were considered along with those of the three additional studies, it was noted that the effect of Axura was smaller in patients with mild disease.
Slovenian: Vendar pa je bilo s primerjavo teh rezultatov z rezultati treh dodatnih študij ugotovljeno, da je bil učinek zdravila Axura manjši pri bolnikih z blago boleznijo.
English: Memantine works by blocking special types of receptor called NMDA receptors, to which the neurotransmitter glutamate normally attaches.
Slovenian: Memantin deluje tako, da zavira posebno vrsto receptorjev, imenovanih receptorji NMDA, na katere se živčni prenašalec glutamat navadno veže.
English: Axura was more effective than placebo at controlling the symptoms of Alzheimer's disease.
Slovenian: Zdravilo Axura je bilo pri nadzorovanju simptomov Alzheimerjeve bolezni učinkovitejše od placeba.
English: The tolerance and dose should be assessed within 3 months after starting treatment, and from then on the benefits of continuing treatment with Axura should be reassessed on a regular basis.
Slovenian: Prenašanje in odmerek zdravila je treba oceniti v 3 mesecih od začetka zdravljenja, od takrat naprej pa je treba koristi zdravljenja z zdravilom Axura ponovno ocenjevati v rednih intervalih.
English: Axura has been studied in three main studies including a total of 1,125 patients with Alzheimer's disease, some of whom had taken other medicines for their disease in the past.
Slovenian: Zdravilo Axura so proučevali v treh glavnih študijah, ki so vključevale skupno 1 125 bolnikov z Alzheimerjevo boleznijo, pri čemer so nekateri izmed njih v preteklosti prejemali druga zdravila za zdravljenje te bolezni.
English: What benefit has Axura shown during the studies?
Slovenian: Kakšne koristi je zdravilo Axura izkazalo med študijami?
English: Axura was compared with placebo (a dummy treatment) over 24 to 28 weeks.
Slovenian: Zdravilo Axura so primerjali s placebom (zdravilom brez zdravilne učinkovine) v obdobju 24 do 28 tednov.
English: Axura is used to treat patients with moderate to severe Alzheimer's disease.
Slovenian: Zdravilo Axura se uporablja za zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo.
English: 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 Axura.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Axura, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer's disease.
Slovenian: Spremembe načina, kako glutamat prenaša signale v možganih, se povezujejo z izgubo spomina, kakršno opažamo pri Alzheimerjevi bolezni.
English: EPAR summary for the public memantine hydrochloride
Slovenian: Povzetek EPAR za javnost memantinijev klorid
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Axura by the patient.
Slovenian: Zdravljenje se sme uvesti samo, če je na voljo negovalec, ki bo redno spremljal bolnikovo jemanje zdravila Axura.
English: Axura must not be used in people who are hypersensitive (allergic) to memantine hydrochloride or any of the other ingredients.
Slovenian: Zdravila Axura ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) memantinijev klorid ali katero koli drugo sestavino zdravila.
English: Axura was also studied in three additional studies including a total of 1,186 patients with mild to severe disease.
Slovenian: Zdravilo Axura so proučevali še v treh dodatnih študijah, ki so vključevale skupno 1 186 bolnikov z blago do hudo boleznijo.
English: Axura is also available as an oral solution, which is supplied with a pump that delivers 5 mg memantine hydrochloride with each activation.
Slovenian: Zdravilo Axura je na voljo tudi kot peroralna raztopina z dodano črpalko, ki dovaja 5 mg memantinijevega klorida ob vsakem črpanju.
English: In the two studies of mild to moderate disease, patients on Axura had less severe symptoms after 24 weeks, as measured on the global and cognitive scores.
Slovenian: V dveh študijah blage do zmerne bolezni so imeli bolniki, ki so prejemali zdravilo Axura, po 24 tednih manj hudih simptomov, merjeno z globalnimi in kognitivnimi merili.
English: What is the risk associated with Axura?
Slovenian: Kakšna tveganja so povezana z zdravilom Axura?
English: The CHMP decided that Axura's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Axura večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: In the study of moderately severe to severe disease, patients taking Axura had fewer symptoms than those taking placebo after 28 weeks, as measured on both global and functional scores.
Slovenian: V študiji z bolniki z zmerno hudo do hudo boleznijo je bilo po 28 tednih pri bolnikih, ki so jemali zdravilo Axura, ugotovljenih manj simptomov kot pri bolnikih, ki so jemali placebo, merjeno z globalnimi in funkcionalnimi merili.
English: Axura is a medicine that contains the active substance memantine hydrochloride.
Slovenian: Axura je zdravilo, ki vsebuje zdravilno učinkovino memantinijev klorid.
English: For the full list of all side effects reported with Axura, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Axura, glejte navodilo za uporabo.
English: The active substance in Axura, memantine hydrochloride, is an antidementia medicine.
Slovenian: Zdravilna učinkovina zdravila Axura, memantinijev klorid, je zdravilo za zdravljenje demence.
English: Why has Axura been approved?
Slovenian: Zakaj je bilo zdravilo Axura odobreno?
English: What is Axura used for?
Slovenian: Za kaj se zdravilo Axura uporablja?
English: How has Axura been studied?
Slovenian: Kako je bilo zdravilo Axura raziskano?
English: What is Axura?
Slovenian: Kaj je zdravilo Axura?
English: How is Axura used?
Slovenian: Kako se zdravilo Axura uporablja?
English: How does Axura work?
Slovenian: Kako zdravilo Axura deluje?
English: The full EPAR for Imatinib medac 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 Imatinib medac je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is also used in children in the ‘chronic phase' of the disease if it is not responding to interferon alpha (another anticancer medicine), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis').
Slovenian: Uporablja se tudi pri otrocih v „kronični fazi“ bolezni, če se ta ne odziva na zdravljenje z interferonom alfa (drugim zdravilom proti raku), in v bolj napredovalih fazah bolezni („pospešeni fazi“ ter „blastni krizi“);
English: Imatinib medac is available as capsules (100 and 400 mg).
Slovenian: Zdravilo Imatinib medac je na voljo v obliki kapsul (100 in 400 mg).
English: The dose depends on the disease being treated, the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day.
Slovenian: Odmerjanje je odvisno od zdravljene bolezni, starosti in stanja bolnika ter odziva na zdravljenje, vendar ne sme preseči 800 mg na dan. Za več informacij glejte navodilo za uporabo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Imatinib medac on 25 September 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Imatinib medac, veljavno po vsej Evropski uniji, izdala 25. septembra 2013.
English: This means that it blocks some specific enzymes known as tyrosine kinases.
Slovenian: To pomeni, da zavira določene encime, imenovane tirozin kinaze.
English: This is a summary of the European public assessment report (EPAR) for Imatinib medac.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Imatinib medac.
English: What measures are being taken to ensure the safe and effective use of Imatinib medac?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Imatinib medac?
English: It is also used alone in adults to treat Ph+ ALL that has returned following previous treatment, or is not responding to other medicines;
Slovenian: Prav tako se pri odraslih uporablja tudi samostojno za zdravljenje ALL Ph+, ki se je po predhodnem zdravljenju ponovno pojavila ali se ne odziva na druga zdravila;
English: The Committee recommended that Imatinib medac be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Imatinib medac odobri za uporabo v EU.
English: This means that some of their genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome.
Slovenian: To pomeni, da je prišlo do prerazporeditve nekaterih genov, s čimer je nastal poseben kromosom, imenovan kromosom Philadelphia.
English: This means that Imatinib medac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Glivec.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Glivec.
English: It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood or solid tumours.
Slovenian: Zdravljenje mora uvesti zdravnik z izkušnjami z zdravljenjem bolnikov s krvnim rakom ali trdnimi tumorji.
English: These enzymes can be found in certain receptors in cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Slovenian: Ti encimi se nahajajo v določenih receptorjih v rakavih celicah, med drugim tudi v receptorjih, ki pospešujejo nenadzorovano deljenje celic.
English: What are the benefits and risks of Imatinib medac?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Imatinib medac?
English: By blocking these receptors, Imatinib medac helps to control cell division.
Slovenian: Z zaviranjem teh receptorjev zdravilo Imatinib medac pomaga nadzorovati delitev celic.
English: Because Imatinib medac is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Imatinib medac generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: A risk management plan has been developed to ensure that Imatinib medac is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Imatinib medac je bil pripravljen načrt obvladovanja tveganj.
English: Imatinib medac is used to treat adults with DFSP that cannot be removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.
Slovenian: Zdravilo Imatinib medac se uporablja za zdravljenje odraslih z DFSP, ki ga ni mogoče kirurško odstraniti, in odraslih, ki niso primerni za kirurški poseg, če se je rak po zdravljenju ponovil ali razširil v druge dele telesa.
English: Imatinib medac is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Slovenian: Zdravilo Imatinib medac se uporablja za zdravljenje odraslih s HES ali KEL, ki imajo specifično prerazporeditev dveh genov, imenovanih FIP1L1 in PDGFRα;
English: Therefore, the CHMP's view was that, as for Glivec, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi, tako kot pri zdravilu Glivec, odtehtajo znana tveganja.
English: For more information about treatment with Imatinib medac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Imatinib medac preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Imatinib medac is a ‘generic medicine'.
Slovenian: Imatinib medac je „generično zdravilo“.
English: What is Imatinib medac and what is it used for?
Slovenian: Kaj je zdravilo Imatinib medac in za kaj se uporablja?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib medac has been shown to have comparable quality and to be bioequivalent to Glivec.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Imatinib medac primerljivo raven kakovosti kot referenčno zdravilo ter da mu je biološko enakovredno.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Imatinib medac, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Imatinib medac is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut.
Slovenian: Zdravilo Imatinib medac se zaužije peroralno z obrokom hrane in velikim kozarcem vode, da se zmanjša tveganje za draženje želodca in črevesja.
English: For practical information about using Imatinib medac, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Imatinib medac naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: • Adults with dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
Slovenian: • odraslih s protuberantnim dermatofibrosarkomom (DFSP), tj. vrsto raka (sarkoma), pri katerem se celice v tkivu pod kožo nenadzorovano delijo.
English: Because Imatinib medac is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Glivec.
Slovenian: Ker je zdravilo Imatinib medac generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Glivec.
English: The active substance in Imatinib medac, imatinib, is a protein-tyrosine kinase inhibitor.
Slovenian: Zdravilna učinkovina zdravila Imatinib medac, imatinib, je zaviralec protein-tirozin-kinaze.
English: • Adults with myelodysplastic or myeloproliferative diseases (MDS/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells.
Slovenian: • odraslih z mielodisplastičnimi ali mieloproliferativnimi boleznimi (MD/MPB), tj. skupino bolezni, pri katerih telo proizvaja veliko število nenormalnih krvnih celic.
English: Imatinib medac is used to treat adults with MDS/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Slovenian: Zdravilo Imatinib medac se uporablja za zdravljenje odraslih z MD/MPB, pri katerih pride do prerazporeditve gena za receptor za rastni faktor iz trombocitov (PDGFR);
English: Imatinib medac is used in combination with other anticancer medicines in patients who have been newly diagnosed with Ph+ ALL.
Slovenian: Zdravilo Imatinib medac se uporablja v kombinaciji z drugimi zdravili proti raku pri bolnikih z na novo postavljeno diagnozo ALL Ph+.
English: • Adults with Ph+ CML in blast crisis;
Slovenian: • odraslih s s kronično mieloično levkemijo s kromosomom Philadelphia (KML Ph+) v blastni krizi;
English: Other information about Imatinib medac
Slovenian: Druge informacije o zdravilu Imatinib medac
English: Imatinib medac is an anticancer medicine that contains the active substance imatinib.
Slovenian: Imatinib medac je zdravilo proti raku, ki vsebuje zdravilno učinkovino imatinib.
English: Imatinib medac is used when the patients are ‘Philadelphia chromosome positive' (Ph+).
Slovenian: Zdravilo Imatinib medac se uporablja pri bolnikih s kromosomom Philadelphia (Ph+).
English: • Adults and children with Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly.
Slovenian: • odraslih in otrok z akutno limfoblastno levkemijo (ALL) s kromosomom Philadelphia, tj. vrsto raka, pri katerem se limfociti (druga vrsta belih krvničk) razmnožujejo prehitro.
English: Imatinib medac is used in children who have been newly diagnosed with Ph+ CML and who are not eligible for a bone marrow transplant.
Slovenian: Zdravilo Imatinib medac se uporablja pri otrocih z na novo postavljeno diagnozo KML Ph+, pri katerih presaditve kostnega mozga ni možno izvesti.