FrancophonIA/ELRC3.0 huggingface dataset:
English: The company that applied for authorisation is Celgene Europe Ltd.
Slovenian: Vlogo za dovoljenje je predložila družba Celgene Europe Ltd.
English: However, the fact that Istodax was not compared with any other treatment did not allow the Committee to conclude on the clinical benefit of the medicine in terms of overall survival (how long the patients lived) or progression-free survival (how long the patients lived without their disease getting worse).
Slovenian: Vendar zaradi dejstva, da zdravila Istodax niso primerjali z nobeno drugo obliko zdravljenja, Odbor ni mogel oceniti kliničnih koristi zdravila v smislu celokupnega preživetja (kako dolgo so bolniki živeli) ali preživetja brez napredovanja bolezni (kako dolgo so bolniki živeli, ne da bi se bolezen poslabšala).
English: Istodax is a medicine that contains the active substance romidepsin.
Slovenian: Istodax je zdravilo, ki vsebuje zdravilno učinkovino romidepsin.
English: As it was not compared with any other treatment, it was not possible to establish whether the observed effects were due to the medicine or due to the disease characteristics of patients in the main study.
Slovenian: Ker ga niso primerjali z nobeno drugo obliko zdravljenja, ni bilo mogoče ugotoviti, ali so bili opaženi učinki povezani z zdravilom ali z značilnostmi bolezni bolnikov, zajetih v študiji.
English: Peripheral T-cell lymphoma is a cancer of a type of white blood cells called T-cells, which are part of the immune system.
Slovenian: Periferni T-celični limfom je rak vrste krvnih celic, imenovanih T-celice, ki so del imunskega sistema.
English: What is Istodax?
Slovenian: Kaj je zdravilo Istodax?
English: The CHMP also noted that, due to an oversight, the company failed to provide an adequate certificate of Good Manufacturing Practice for the site where the medicine is manufactured, which is legally required.
Slovenian: CHMP je ugotovil tudi, da družba pomotoma ni predložila ustreznega zakonsko predpisanega potrdila o dobri proizvodni praksi za prostor, kjer poteka proizvodnja zdravila.
English: Therefore it was not possible to conclude that the benefits of the medicine outweigh the risks and the CHMP confirmed its initial negative opinion.
Slovenian: Posledično CHMP ni mogel oceniti, ali koristi zdravila odtehtajo z njim povezana tveganja, zato je potrdil svoje prvotno negativno mnenje.
English: Istodax was expected to be used for the treatment of adults with peripheral T-cell lymphoma that no longer responds to or has come back after at least two previous therapies.
Slovenian: Zdravilo Istodax naj bi se uporabljalo za zdravljenje odraslih bolnikov s perifernim T-celičnim limfomom, ki se ne odziva več na terapije ali pa se je ponovno pojavil po vsaj dveh predhodnih terapijah.
English: On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Istodax, intended for the treatment of peripheral T-cell lymphoma.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je 19. julija 2012 sprejel negativno mnenje in priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Istodax, namenjenim za zdravljenje perifernega T-celičnega limfoma.
English: Refusal of the marketing authorisation for Istodax (romidepsin)
Slovenian: Zavrnitev vloge za dovoljenje za promet z zdravilom Istodax (romidepsin)
English: It was to be available as a powder and solvent to be made into a solution for infusion (drip into a vein).
Slovenian: Zdravilo naj bi bilo na voljo v obliki praška in vehikla za pripravo raztopine za infundiranje (kapalne infuzije v veno).
English: In November 2012, following the re-examination, the CHMP removed its concern over the certificate of Good Manufacturing Practice, but retained its other concerns.
Slovenian: Novembra 2012 je CHMP po ponovnem pregledu ugotovil, da ni več zadržka glede potrdila o dobri proizvodni praksi, drugi pomisleki pa še vedno ostajajo.
English: Istodax was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 October 2005 for the treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated).
Slovenian: Zdravilo Istodax je bilo dne 28. oktobra 2005 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje perifernega T-celičnega limfoma (nodalni, ekstranodalni in levkemični/diseminirani).
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Istodax.
Slovenian: Družba je CHMP obvestila, da zavrnitev nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Istodax.
English: The exact way that romidepsin works in peripheral T-cell lymphoma is not known, but its effects on genes that regulate cell proliferation and cell death are expected to lead to a reduction in the rate of growth and division of the cancer cells.
Slovenian: Natančen mehanizem delovanja romidepsina pri zdravljenju T celičnega limfoma ni znan, vendar naj bi njegovo delovanje na gene, ki uravnavajo proliferacijo in odmiranje celic, upočasnilo rast in delitev rakavih celic.
English: The company presented the results from one main study with Istodax involving 131 patients with peripheral T-cell lymphoma who had received previous treatment.
Slovenian: Družba je predložila rezultate ene glavne študije, v kateri je 131 bolnikov s perifernim T-celičnim limfomom, ki so predhodno že bili zdravljeni, prejemalo zdravilo Istodax.
English: What was Istodax expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Istodax uporabljalo?
English: The active substance in Istodax, romidepsin, is expected to work by blocking the activity of proteins called histone deacetylases, which are involved in turning genes ‘on' and ‘off' within cells.
Slovenian: Zdravilna učinkovina v zdravilu Istodax, romidepsin, naj bi zavirala delovanje beljakovin, imenovanih histonske deacetilaze, ki sodelujejo v procesu aktiviranja in deaktiviranja genov v celicah.
English: How is Istodax expected to work?
Slovenian: Kako naj bi zdravilo Istodax delovalo?
English: In July 2012, the CHMP noted that the main study showed that Istodax had anti-tumour activity in terms of patients' response to treatment.
Slovenian: Julija 2012 je CHMP na podlagi odziva bolnikov na zdravljenje zaključil, da je študija pokazala, da je imelo zdravilo Istodax protitumorske učinke.
English: In both studies there were no cases of resistance to treatment after 48 weeks.
Slovenian: V obeh študijah po 48 tednih ni bilo nobenih primerov odpornosti na zdravljenje.
English: What measures are being taken to ensure the safe and effective use of Dovato?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Dovato?
English: Dovato (dolutegravir / lamivudine)
Slovenian: Dovato (dolutegravir/lamivudin)
English: An overview of Dovato and why it is authorised in the EU
Slovenian: Pregled zdravila Dovato in zakaj je odobreno v EU
English: As for all medicines, data on the use of Dovato are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Dovato stalno spremljajo.
English: Other information about Dovato
Slovenian: Druge informacije o zdravilu Dovato
English: Both active substances have already been authorised in the European Union as separate tablets: dolutegravir in 2014 and lamivudine in 1996.
Slovenian: Obe učinkovini sta v Evropski uniji že pridobili dovoljenje za promet v obliki ločenih tablet: dolutegravir leta 2014 in lamivudin leta 1996.
English: What benefits of Dovato have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Dovato izkazalo v študijah?
English: Dovato is available as tablets containing 50 mg of dolutegravir and 300 mg of lamivudine.
Slovenian: Zdravilo Dovato je na voljo v obliki tablet, ki vsebujejo 50 mg dolutegravirja in 300 mg lamivudina.
English: Why is Dovato authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Dovato odobreno v EU?
English: Side effects reported with Dovato are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Dovato, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dovato have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Dovato upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: What are the risks associated with Dovato?
Slovenian: Kakšna tveganja so povezana z zdravilom Dovato?
English: Dovato (dolutegravir / lamivudine) EMA/276259/2019
Slovenian: Dovato (dolutegravir/lamivudin) EMA/276259/2019
English: What is Dovato and what is it used for?
Slovenian: Kaj je zdravilo Dovato in za kaj se uporablja?
English: In these studies, 91% of patients with HIV-1 who took the Dovato combination no longer had detectable levels of HIV (below 50 copies per ml) after 48 week compared with 93% of those who were taking the triple combination.
Slovenian: V teh študijah pri 91 % bolnikov z virusom HIV-1, ki so jemali kombinacijo učinkovin v zdravilu Dovato, po 48 tednih ni bilo več zaznavnih ravni virusa HIV (pod 50 kopij na ml) v primerjavi s 93 % tistih, ki so jemali kombinacijo treh učinkovin.
English: Triple combination therapy is used for HIV treatment to reduce the chance of the virus becoming resistant to treatment.
Slovenian: Zdravljenje s kombinacijo treh učinkovin se uporablja za zdravljenje okužbe z virusom HIV za zmanjšanje možnosti, da bi virus postal odporen na zdravljenje.
English: Dolutegravir stops the activity of an enzyme called integrase (and is known as an integrase inhibitor), while lamivudine stops the activity of reverse transcriptase (and is known as a nucleoside reverse transcriptase inhibitor or NRTI).
Slovenian: Dolutegravir zavira delovanje encima, imenovanega integraza (in je znan kot zaviralec integraze), lamivudin pa ustavi delovanje reverzne transkriptaze (in je znan kot nukleozidni zaviralec reverzne transkriptaze ali NRTI).
English: Dovato does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Dovato ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
English: The most common serious side effects (which may affect up to 1 in 100 people) are allergic reactions, including rash and severe liver problems.
Slovenian: Najresnejši neželeni učinki (ki se lahko pojavijo pri največ 1 bolniku od 100) so alergijske reakcije, vključno z izpuščajem ali hudimi težavami z jetri.
English: This medicine contains the active substances dolutegravir and lamivudine and is used to treat infections that are not resistant to medicines of the same class as dolutegravir or to lamivudine.
Slovenian: To zdravilo vsebuje učinkovini dolutegravir in lamivudin ter se uporablja za zdravljenje okužb, ki niso odporne na zdravila iz istega razreda, kot je dolutegravir, ali na lamivudin.
English: The two active substances in Dovato, dolutegravir and lamivudine, block the activity of enzymes that the virus uses to make new copies of itself.
Slovenian: Obe učinkovini v zdravilu Dovato, dolutegravir in lamivudin, zavirata dejavnost encimov, ki jih virus uporablja za izdelavo novih kopij.
English: The most common side effects with Dovato (which may affect up to 1 in 10 people) are headache, diarrhoea, nausea and difficulty sleeping.
Slovenian: Najpogostejši neželeni učinki zdravila Dovato (ki se lahko pojavijo pri največ 1 bolniku od 10) so glavobol, driska, slabost in težave s spanjem.
English: Dovato received a marketing authorisation valid throughout the EU on 1 July 2019 Further information on Dovato can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dovato This overview was last updated in 08-2019.
Slovenian: Nadaljnje informacije o zdravilu Dovato so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/dovato
English: Two main studies, involving 1,441 patients, have shown that the combination of the two active substances in Dovato is as effective at lowering the amount of HIV in the blood as a triple combination therapy (dolutegravir plus tenofovir plus emtricitabine).
Slovenian: V dveh glavnih študijah, v kateri je bilo vključeno 1 433 bolnikov, sta pokazali, da je kombinacija obeh učinkovin v zdravilu Dovato enako učinkovita pri zniževanju količine virusa HIV v krvi kot zdravljenje s kombinacijo treh učinkovin (dolutegravir ter tenofovir in emtricitabin).
English: Dovato can only be obtained with a prescription and should be prescribed by a doctor who is experienced in managing HIV infection.
Slovenian: Predpisovanje in izdaja zdravila Dovato je le na recept, predpisati pa ga mora zdravnik z izkušnjami z zdravljenjem okužb z virusom HIV.
English: Dovato is a medicine for treating infection with human immunodeficiency virus type 1 (HIV-1) in adults and adolescents over 12 years old who weigh at least 40 kg.
Slovenian: Dovato je zdravilo, ki se uporablja za zdravljenje odraslih in mladostnikov, starejših od 12 let, ki tehtajo vsaj 40 kg, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1).
English: How does Dovato work?
Slovenian: Kako zdravilo Dovato deluje?
English: In two main studies, the Dovato combination was just as effective as a triple combination in patients with HIV-1, with no cases of resistance developing in these patients.
Slovenian: V dveh glavnih študijah je bila pri bolnikih z okužbo z virusom HIV-1 kombinacija dveh učinkovin v zdravilu Dovato enako učinkovita kot kombinacija treh učinkovin, pri čemer pa pri teh bolnikih ni bil ugotovljen noben primer razvoja odpornosti.
English: How is Dovato used?
Slovenian: Kako se zdravilo Dovato uporablja?
English: For more information about using Dovato, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Bolnik mora vzeti eno tableto na dan. Za več informacij glede uporabe zdravila Dovato glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Furthermore, both active substances are available in a single tablet and are acceptably safe.The European Medicines Agency therefore decided that Dovato's benefits are greater than its risks and that it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato sklenila, da so koristi zdravila Dovato večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: 3 (3x1) inhalers (360(3x120) actuations) (multipack)
Slovenian: 3 (3 x 1) inhalatorji (360 (3 x 120) sprožitev) (skupno pakiranje)
English: 1 inhaler (120 actuations)
Slovenian: 1 inhalator (120 sprožitev)
English: Strength Pharmaceutical Form
Slovenian: Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
English: There is no specific antidote.
Slovenian: Ne obstaja specifičen antidot.
English: Take the next dose normally, when it is time to take it.
Slovenian: Naslednji odmerek vzemite kot običajno, ko je čas, da ga vzamete.
English: • Not known (frequency cannot be estimated from the available data)
Slovenian: Neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
English: Any suspicious skin lesion should be evaluated by a specialist.
Slovenian: Vsako sumljivo kožno lezijo mora oceniti specialist.
English: There was a significant and beneficial effect in quality of life (as assessed by PD-QUALIF scale).
Slovenian: Izražen je bil tudi pomemben in koristen učinek na kvaliteto življenja (ocenjeno s PD-QUALIF lestvico).
English: 597 678 01 Blansko Czech Republic
Slovenian: 597 678 01 Blansko Češka Republika
English: The effect was evident, although its magnitude was modest in this patient population with mild disease.
Slovenian: Učinek je bil očiten, čeprav je bil njegov obseg v tej populaciji z blago boleznijo zmeren.
English: The frequency of possible side effects listed below is defined using the following convention:
Slovenian: Pogostost spodaj navedenih možnih neželenih učinkov je opredeljena v skladu z naslednjim dogovorom:
English: Your doctor may need to adjust or stop your dose.
Slovenian: Zdravnik bo moral morda prilagoditi odmerek ali prekiniti zdravljenje.
English: This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Slovenian: Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> <{mesec LLLL}>
English: The robustness of the results for the primary efficacy end point, was confirmed in a battery of additional statistical models and was demonstrated in three cohorts (ITT, per protocol and completers).
Slovenian: Moč rezultatov za primarno merilo končne učinkovitosti je bila potrjena v bateriji dodatnih statističnih modelov in prikazana v treh kohortah (ITT, na protokol in zaključene).
English: In a single-dose study healthy volunteers received 20 mg/day and in a ten-day study healthy volunteers received 10 mg/day.
Slovenian: V študiji z enojnimi odmerki so zdravi prostovoljci dobili odmerek 20 mg/dan in v desetdnevni študiji so zdravi prostovoljci prejemali odmerek 10 mg/dan.
English: Rasagiline is not recommended for use in children and adolescents due to lack of data on safety and efficacy.
Slovenian: Uporaba razagilina pri otrocih in mladostnikih ni priporočljiva zaradi nezadostnih podatkov o varnosti in učinkovitosti.
English: Patients should be cautioned about operating hazardous machines, including motor vehicles, until they are reasonably certain that Rasagiline does not affect them adversely.
Slovenian: Bolnike je potrebno opozoriti, naj ne upravljajo nevarnih strojev, vključno z motornimi vozili, dokler niso ustrezno prepričani, da razagilin na njih ne vpliva škodljivo.
English: Adverse events were mild or moderate and not related to rasagiline treatment.
Slovenian: Neželeni učinki so bili blagi ali zmerni in niso bili povezani z zdravljenjem z razagilinom.
English: Elderly No change in dose is required for elderly patients.
Slovenian: Za starejše bolnike ni potrebno spreminjanje odmerka.
English: Less than 1% of rasagiline is excreted as unchanged product in urine.
Slovenian: Manj kot 1% razagilina se izloči nespremenjenega z urinom.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Slovenian: Ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Dopamine is a chemical in the brain involved in movement control.
Slovenian: Dopamin je kemična snov v možganih, ki sodeluje pri nadzorovanju gibanja.
English: Patients should be regularly monitored for the development of impulse control disorders.
Slovenian: Bolnike je treba redno spremljati zaradi možnosti razvoja motenj pri obvladovanju impulzov.
English: In case of overdose, patients should be monitored and the appropriate symptomatic and supportive therapy instituted.
Slovenian: V primerih prevelikega odmerjanja je potrebno bolnika opazovati ter uvesti ustrezno simptomatsko in podporno zdravljenje.
English: Parkinson's disease is associated with symptoms of hallucinations and confusion.
Slovenian: Parkinsonovo bolezen spremljajo simptomi halucinacij in zmedenosti.
English: Animals studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Slovenian: Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
English: In both studies, the primary measure of efficacy was the change from baseline to treatment period in the mean number of hours that were spent in the “OFF” state during the day (determined from “24-hour” home diaries completed for 3 days prior to each of the assessment visits).
Slovenian: V obeh študijah je bilo primarno merilo učinkovitosti sprememba povprečnega števila ur v dnevu, preživetih v »OFF« stanju od izhodišča do konca zdravljenja (opredeljenih iz »24-urnih« domačih dnevnikov, ki so bili zaključeni 3 dni pred vsakim ocenjevalnim obiskom).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete katero koli zdravilo.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription or if you are smoking or intend to stop smoking.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta ali če kadite oziroma nameravate opustiti kajenje.
English: The absolute bioavailability of a single rasagiline dose is about 36%.
Slovenian: Absolutna biološka uporabnost enkratnega odmerka razagilina je okoli 36%.
English: There was also a statistically significant improvement over placebo with the rasagiline 0.5 mg group, yet the magnitude of improvement was lower.
Slovenian: Tudi v skupini z 0,5 mg razagilina je bilo v primerjavi s placebom statistično pomembno izboljšanje, vendar je bil obseg izboljšanja manjši.
English: Rasagiline did not present genotoxic potential in vivo and in several in vitro systems using bacteria or hepatocytes.
Slovenian: Razagilin ne izraža genotoksičnega potenciala v in vivo in v številnih in vitro sistemih, ki uporabljajo bakterije ali hepatocite.
English: The mean volume of distribution following a single intravenous dose of rasagiline is 243 l.
Slovenian: Povprečni volumen porazdelitve, ki sledi enkratnemu intravenskemu odmerku razagilina, je 243 l.
English: Rasagiline is administered orally, at a dose of 1 mg once daily with or without levodopa.
Slovenian: Razagilin se daje peroralno v odmerku 1 mg enkrat dnevno, z ali brez levodope.
English: Children and adolescents Rasagiline Mylan is not recommended for use under the age of 18.
Slovenian: Otroci in mladostniki Jemanje zdravila Razagilin Mylan ni priporočeno za mlajše od 18 let.
English: Rasagiline is rapidly absorbed, reaching peak plasma concentration (Cmax) in approximately 0.5 hours.
Slovenian: Razagilin se hitro absorbira, vrh plazemske koncentracije (Cmax) doseže v približno v 0,5 ure.
English: Patients with Parkinson's disease are particularly vulnerable to the adverse effects of hypotension due to existing gait issues.
Slovenian: Bolniki s Parkinsonovo boleznijo so še posebej ranljivi na neželene učinke hipotenzije zaradi obstoječe problematike s hojo.
English: Food does not affect the Tmax of rasagiline, although Cmax and exposure (AUC) are decreased by approximately 60% and 20%, respectively, when the medicinal product is taken with a high fat meal.
Slovenian: Hrana ne vpliva na Tmax razagilina, čeprav se Cmax in izpostavljenost (AUC) zmanjšata za približno 60% oz. 20%, ko se zdravilo vzame z zelo mastnim obrokom.
English: Rasagiline Mylan is used for the treatment of Parkinson's disease.
Slovenian: Zdravilo Razagiline Mylan se uporablja pri zdravljenju Parkinsonove bolezni.
English: Do not use this medicine after the expiry date which is stated on the carton or blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali pretisnem omotu.