FrancophonIA/ELRC3.0 huggingface dataset:
English: * Each patient was counted only once (first component event) in the component summary that contributed to the primary efficacy endpoint K-M estimate at 1,080 days Hazard ratio is Zontivity group versus placebo group Cox proportional hazard model with covariates treatment and stratification factors (qualifying atherosclerotic disease and planned thienopyridine use)
Slovenian: * Vsak bolnik je bil štet le enkrat (prva komponenta dogodka) v skupnem seštevku, ki je prispeval k primarnemu opazovanemu dogodku učinkovitosti.
English: BLISTER - unit dose
Slovenian: PRETISNI OMOT - enoodmerni
English: Merck Sharp & Dohme Ltd
Slovenian: Imetnik dovoljenja za promet z zdravilom Izdelovalec Merck Sharp & Dohme Ltd
English: • Severe hepatic impairment.
Slovenian: • huda okvara jeter.
English: Tablet core
Slovenian: Telesna masa
English: Hazard ratio is Zontivity group versus placebo group
Slovenian: Razmerje tveganj je skupina z zdravilom Zontivity v primerjavi s skupino s placebom.
English: Hepatic Impairment
Slovenian: Bolezni sečil
English: Stroke
Slovenian: Zmerne
English: TIMI Bleeding Category Major
Slovenian: Kategorije krvavitev po TIMI Večje
English: Vorapaxar should not be initiated in patients taking prasugrel or ticagrelor and in case of need for additional therapy with these agents, vorapaxar should be stopped.
Slovenian: V primeru, da je potrebno dodatno zdravljenje s tema učinkovinama, je treba vorapaksar ukiniti.
English: Severe hepatic impairment
Slovenian: Žilne bolezni hematom krvavitev
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Slovenian: Izgled zdravila Zontivity in vsebina pakiranja
English: Haemorrhage
Slovenian: pvrednost
English: Hepatic impairment
Slovenian: Miokardni infarkt
English: PAD
Slovenian: Dojenje
English: Outcome of a procedure under Article 13 of Regulation (EC) 1234/2008
Slovenian: Izid postopka v skladu s členom 13 Uredbe (ES) št. 1234/2008
English: The sooner it is taken after having unprotected sex the more effective it will be.
Slovenian: Prej kot se po nezaščitenem spolnem odnosu vzame, bolj učinkovit bo.
English: The company wanted this change to be recognised in Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain and Sweden.
Slovenian: Družba je želela, da se ta sprememba prizna v Avstriji, Belgiji, na Češkem, Danskem, v Estoniji, Franciji, Grčiji, na Irskem,
English: Why was Levonelle reviewed?
Slovenian: Zakaj je bilo zdravilo Levonelle pregledano?
English: This could mean that the contraceptive effects of Levonelle are reduced.
Slovenian: To bi lahko pomenilo, da so kontracepcijski učinki zdravila Levonelle zmanjšani.
English: Levonelle has been authorised in the EU under a mutual recognition procedure based on an initial authorisation granted by the United Kingdom on 15 June 2004.
Slovenian: Zdravilo Levonelle je bilo v EU odobreno za promet po postopku medsebojnega priznavanja na osnovi začetnega dovoljenja, ki ga je 15. junija 2004 podelilo Združeno kraljestvo.
English: On 1 October 2015, the UK referred the matter to the CHMP for arbitration.
Slovenian: 1. oktobra 2015 je Združeno kraljestvo z namenom arbitraže zadevo napotilo na odbor CHMP.
English: In most EU Member States Levonelle and associated names can be obtained without a prescription.
Slovenian: V večini držav članic EU je mogoče zdravilo Levonelle in povezana imena dobiti brez recepta.
English: The company that markets these medicines is Gedeon Richter Plc.
Slovenian: Ta zdravila trži farmacevtska družba Gedeon Richter Plc.
English: Levonelle contains levonorgestrel, which works mainly by preventing or delaying ovulation.
Slovenian: Zdravilo Levonelle vsebuje levonorgestrel, ki deluje predvsem tako, da prepreči ali odloži ovulacijo.
English: Although the review did not cover the 750 microgram Levonelle tablets, the CHMP recommended that similar changes should be considered for these medicines.
Slovenian: Čeprav pregled ni vključeval zdravila Levonelle v obliki 750-mikrogramskih tablet, je odbor CHMP priporočil, da se podobne spremembe pretehtajo tudi za ta zdravila.
English: It is available as a single tablet containing 1500 microgram levonorgestrel or as two tablets each containing 750 microgram levonorgestrel.
Slovenian: Na voljo je v obliki posamezne tablete, ki vsebuje 1 500 mikrogramov levonorgestrela, ali v obliki dveh tablet, od katerih vsaka vsebuje 750 mikrogramov levonorgestrela.
English: In addition there were concerns that, since Levonelle is available without prescription in many EU Member States, any new advice issued could lead to medication errors as there may not always be a consultation with a healthcare professional prior to taking the medicine.
Slovenian: Poleg tega so obstajali pomisleki, da bi, glede na to, da je v številnih državah članica EU zdravilo Levonelle na voljo brez recepta, vsako novo izdano navodilo lahko privedlo do napak pri jemanju, saj pred jemanjem zdravila ni vedno posveta z zdravnikom.
English: This review only covered the 1500 microgram tablets.
Slovenian: V tem pregledu so bile obravnavane le 1 500-mikrogramske tablete.
English: On 26 May 2016, the European Medicines Agency completed a review for the emergency contraceptive Levonelle (levonorgestrel, 1500 microgram tablets) and associated names.
Slovenian: Evropska agencija za zdravila je 26. maja 2016 zaključila pregled urgentnega kontracepcijskega zdravila Levonelle (levonorgestrel, 1 500-mikrogramske tablete) in povezanih imen.
English: Levonelle is an emergency contraceptive used to prevent unintended pregnancy when taken within 72 hours (3 days) of unprotected intercourse or failure of a contraceptive method.
Slovenian: Zdravilo Levonelle je urgentni kontraceptiv, ki se uporablja za preprečevanje nenačrtovane nosečnosti v 72 urah (treh dneh) po nezaščitenem spolnem odnosu ali pri pomanjkljivi kontracepcijski metodi.
English: What is Levonelle?
Slovenian: Kaj je zdravilo Levonelle?
English: Based on data on interactions with these medicines, which all increase the activity of the liver enzyme CYP3A4, as well as data on combined hormonal contraceptives, the CHMP concluded that interactions between these medicines and Levonelle may prevent Levonelle from working effectively and could lead to contraceptive failure.
Slovenian: Na osnovi podatkov o medsebojnem delovanju s temi zdravili, ki vsa povečajo aktivnost jetrnega encima CYP3A4, in podatkov o kombiniranih hormonskih kontraceptivih je odbor CHMP zaključil, da bi medsebojno delovanje med temi zdravili in zdravilom Levonelle lahko preprečevalo učinkovito delovanje zdravila Levonelle in povzročilo, da je kontracepcija neuspešna.
English: On 17 September 2014, the company for Levonelle applied for a change to the marketing authorisation to include the HIV medicine efavirenz as an interacting medicine in the product information.
Slovenian: 17. septembra 2014 je podjetje za zdravilo Levonelle zaprosilo za spremembo dovoljenja za promet, s katero bi se v informacije o zdravilu kot medsebojno delujoče zdravilo dodalo zdravilo efavirenz.
English: No increased risk of side effects is expected from the higher dose.
Slovenian: Ob večjem odmerku ni pričakovati povečanega tveganja za neželene učinke.
English: The grounds for the referral were concerns from Italy that there are insufficient clinical data to support doubling the dose of Levonelle in cases where the woman is also taking a medicine that interacts with Levonelle.
Slovenian: Razlog za napotitev so bili pomisleki Italije, da ni zadostnih kliničnih podatkov, da bi v primerih, kadar ženska jemlje tudi zdravilo, ki medsebojno deluje z zdravilom Levonelle, podprli podvojitev odmerka zdravila Levonelle.
English: Although the Member States agreed that efavirenz interacts with levonorgestrel and that this information should be included in the product information, the Member States were unable to reach an agreement on how this interaction should be managed and whether specific recommendations such as dose adjustment were required for women taking Levonelle while on efavirenz or other medicines which also reduce levonorgestrel levels.
Slovenian: Čeprav so se države članice strinjale, da efavirenz medsebojno deluje z levonorgestrelom in da bi bilo to informacijo treba vključiti v informacije o zdravilu, se niso mogle zediniti o tem, kako naj bo ta interakcija obravnavana in katera specifična priporočila, kot npr. prilagoditev odmerka, so potrebna za ženske, ki jemljejo zdravilo Levonelle ob jemanju efavirenza ali drugih zdravil, ki prav tako zmanjšujejo ravni levonorgestrela.
English: The European Commission issued an EU-wide legally binding decision to implement the CHMP recommendations on Levonelle on 01/08/2016.
Slovenian: Evropska komisija je dne 01/08/2016 izdala končno pravno zavezujočo odločbo za vse države članice EU, da uvedejo priporočila odbora CHMP o zdravilu Levonelle.
English: However, Levonelle should only be used with these medicines when a non-hormonal emergency contraceptive (i.e. a copper intrauterine device) is not an option.
Slovenian: Vendar pa se sme zdravilo Levonelle s temi zdravili uporabljati le, kadar ni možna uporaba nehormonskega urgentnega kontraceptiva (tj. bakrenega intrauterinega pripomočka).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that when Levonelle is taken together with certain interacting medicines (including the HIV medicine efavirenz and ritonavir, certain medicines for tuberculosis and epilepsy and herbal medicines containing St John's wort) the dose of Levonelle should be doubled.
Slovenian: Odbor agencije za zdravila za uporabo v humani medicini (CHMP) je priporočil, da se v primeru, ko se zdravilo Levonelle jemlje hkrati z nekaterimi medsebojno delujočimi zdravili (vključno z zdraviloma proti virusu HIV efavirenz in ritonavir, nekaterimi zdravili proti tuberkulozi in epilepsiji ter zeliščnimi zdravili, ki vsebujejo šentjanževko), odmerek zdravila Levonelle podvoji.
English: However, when this is not an option, the CHMP considered that doubling the dose of Levonelle from 1500 to 3000 microgram is recommended to compensate for the reduction in blood levonorgestrel levels.
Slovenian: Kadar to ni mogoče, pa je po mnenju odbora CHMP za nadomestitev zmanjšanja krvne ravni levonorgestrela smiselno podvojiti odmerek zdravila Levonelle s 1 500 na 3 000 mikrogramov.
English: The CHMP recommended that women who use liver enzyme inducers should instead use a non-hormonal emergency contraceptive (i.e. a copper intrauterine device) which is not affected by liver enzyme inducing medicines.
Slovenian: Odbor CHMP je priporočil, naj ženske, ki uporabljajo induktorje jetrnih encimov, namesto tega rajši uporabljajo nehormonski urgentni kontraceptiv (tj. bakren intrauterini pripomoček), na katerega jetrne encime inducirajoča zdravila ne vplivajo.
English: The CHMP noted that the reductions in blood levels of levonorgestrel seen with efavirenz were similar to those seen with other medicines (so-called liver enzyme inducers) that interact with levonorgestrel (including certain medicines for tuberculosis and epilepsy and herbal medicines containing St John's wort).
Slovenian: Odbor CHMP je ugotovil, da so zmanjševanja ravni levonorgestrela v krvi pri jemanju efavirenza podobna, kot so opažena pri drugih zdravilih (t. i. induktorjih jetrnih encimov), ki medsebojno delujejo z levonorgestrelom (vključno z nekaterimi zdravili proti tuberkulozi in epilepsiji ter zeliščnimi zdravili, ki vsebujejo šentjanževko).
English: Feedback was sought from patients and relevant healthcare professionals to ensure that women could identify when to use a double dose versus a single dose based on the information provided.
Slovenian: Zaželjene so bile povratne informacije uporabnic in udeleženih zdravstvenih delavcev, da bi zagotovili, da na osnovi predloženih informacij ženske lahko prepoznajo, kdaj morajo namesto enojnega vzeti dvojni odmerek.
English: around 50% in women taking efavirenz, which is known to increase the activity of a particular liver enzyme (CYP3A4) which is involved in the breakdown of levonorgestrel.
Slovenian: Prošnja je temeljila na študiji, ki je pokazala, da je raven levonorgestrela za okoli 50 % zmanjšana pri ženskah, ki jemljejo efavirenz, saj ta učinkovina zveča aktivnost določenega jetrnega encima (CYP3A4), ki razgrajuje levonorgestrel.
English: In order to ensure the correct use of Levonelle, the CHMP recommended including advice on when to take a double dose on the medicine's outer carton as well as in the package leaflet.
Slovenian: Da bi zagotovili ustrezno uporabo zdravila Levonelle, je odbor CHMP priporočil vključitev nasveta o tem, kdaj vzeti dvojni odmerek zdravila, na zunanjo ovojnino in v navodilo za uporabo.
English: In order to ensure the correct use of Levonelle, the CHMP also recommended including advice on when to take a double dose on the medicine's outer carton as well as in the package leaflet.
Slovenian: Da bi zagotovili ustrezno uporabo zdravila Levonelle, je odbor CHMP priporočil tudi, da se nasvet o tem, kdaj vzeti dvojni odmerek zdravila, doda na zunanjo ovojnino in v navodilo za uporabo.
English: It was to be available as capsules.
Slovenian: Na voljo naj bi bilo v obliki kapsul.
English: EMA/311892/2014 EMEA/H/C/002546
Slovenian: 23. maj 2014 EMA/405473/2014 EMEA/H/C/002546
English: The CHMP opinion has no consequences on these trials.
Slovenian: Mnenje odbora CHMP nima nobenih posledic za ta preskušanja.
English: If you are taking part in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Slovenian: Če sodelujete v kliničnem preskušanju in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
English: Both studies lasted two years and the main measure of effectiveness was based on the reduction in the number of relapses per patient per year (what is known as the ‘annualised relapse rate').
Slovenian: Obe študiji sta trajali dve leti, glavno merilo učinkovitosti pa je temeljilo na zmanjšanju števila recidivov na bolnika na leto (temu pravimo „letna stopnja recidivov“).
English: In addition, the Committee was not convinced about the effectiveness of the company's proposed measures to prevent pregnancies in women who would take the medicine.
Slovenian: Poleg tega ni bil prepričan o učinkovitosti ukrepov, ki jih je družba predlagala za preprečevanje nosečnosti pri ženskah, ki naj bi uporabljale zdravilo.
English: The company that applied for authorisation is Teva Pharma GmbH.
Slovenian: Vlogo za pridobitev dovoljenja je predložila družba Teva Pharma GmbH.
English: The effects of Nerventra were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Nerventra so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Nerventra, intended for the treatment of multiple sclerosis.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je 23. januarja 2014 sprejel negativno mnenje, s katerim je priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Nerventra, namenjenim za zdravljenje multiple skleroze.
English: What is Nerventra?
Slovenian: Kaj je zdravilo Nerventra?
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 22 May 2014.
Slovenian: Po preučitvi podlage za to zahtevo je odbor CHMP ponovno pregledal prvotno mnenje in 22. maja 2014 potrdil zavrnitev izdaje dovoljenja za promet z zdravilom.
English: The expert group advised that the risks seen in animal studies could have been acceptable if a clear benefit was seen in clinical studies, although a strict pregnancy prevention scheme would have been required.
Slovenian: Strokovnjaki so menili, da bi tveganja, opažena v študijah na živalih, lahko bila sprejemljiva, če bi v kliničnih študijah opazili jasno korist, čeprav bi bil potreben strog program za preprečevanje nosečnosti.
English: The exact way Nerventra works is not known, but it is believed to have a modulator effect on the immune system (the body's defences).
Slovenian: Natančen način delovanja zdravila Nerventra ni znan, vendar se domneva, da vpliva na način delovanja imunskega sistema (obrambnega mehanizma telesa).
English: At the time of the initial recommendation, the CHMP had concerns about results from animal studies showing a higher occurrence of cancers after long-term exposure to the medicine and noted that a similar long-term cancer risk could not be excluded in humans, especially when considering that the way the medicine works in the body is unclear.
Slovenian: V času izdaje prvotnega priporočila je bil odbor CHMP zaskrbljen glede rezultatov študij na živalih, ki so pokazali pogostejši pojav raka po dolgotrajni izpostavljenosti zdravilu, in izpostavil, da ni mogoče izključiti podobnega dolgoročnega tveganja za raka pri ljudeh, zlasti glede na to, da način delovanja zdravila v telesu ni pojasnjen.
English: There was also a possible risk (again from animal studies) of effects on the unborn baby when the medicine is taken by pregnant women.
Slovenian: Poleg tega obstaja možno tveganje (prav tako opaženo v študijah na živalih) za učinke na nerojenega otroka, če bi zdravilo uporabljale nosečnice.
English: Refusal of the marketing authorisation for Nerventra (laquinimod)
Slovenian: Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Nerventra (lakinimod)
English: The CHMP noted that the risk could not be excluded with current data and that animal studies suggest that some of the harmful effects may be delayed and only seen later on in the child's life.
Slovenian: Odbor CHMP je izpostavil, da tveganja na podlagi trenutnih podatkov ni mogoče izključiti in da študije na živalih kažejo, da bi nekateri škodljivi učinki lahko nastopili z zakasnitvijo in postali opazni šele kasneje v otrokovem življenju.
English: During the re-examination, the CHMP considered advice from an expert group in neurology.
Slovenian: Med ponovnim pregledom je odbor CHMP upošteval mnenje skupine strokovnjakov s področja nevrologije.
English: Nerventra was expected to be used to treat multiple sclerosis (MS), a disease in which the immune system malfunctions, causing inflammation that destroys the protective sheath around the nerves in the brain and spinal cord.
Slovenian: Zdravilo Nerventra naj bi se uporabljalo za zdravljenje multiple skleroze (MS), tj. bolezni, pri kateri imunski sistem ne deluje pravilno in povzroči vnetje, ki poškoduje zaščitno ovojnico okrog živcev v možganih in hrbtenjači.
English: The company also provided results of two main studies in patients with relapsing-remitting MS. One of the studies involving 1,106 patients compared Nerventra with placebo (a dummy treatment), while the second study in 1,331 patients compared Nerventra with placebo and another medicine used to treat MS, interferon-beta 1a.
Slovenian: V prvi študiji, v kateri je sodelovalo 1 106 bolnikov, so zdravilo Nerventra primerjali s placebom (zdravilom brez zdravilne učinkovine), v drugi študiji, v kateri je sodelovalo 1 331 bolnikov, pa so zdravilo Nerventra primerjali s placebom in drugim zdravilom za zdravljenje MS, interferonom beta-1a.
English: The CHMP noted that the effect of the medicine in preventing relapses was modest, and though its effect in slowing the worsening of disability was encouraging it still needed to be confirmed.
Slovenian: Odbor CHMP je izpostavil, da je bil učinek zdravila pri preprečevanju recidivov skromen, učinek pri upočasnitvi napredovanja prizadetosti pa je bil sicer spodbuden, vendar ga je treba še potrditi.
English: Nerventra is a medicine that contains the active substance laquinimod.
Slovenian: Nerventra je zdravilo, ki vsebuje zdravilno učinkovino lakinimod.
English: Therefore the Committee concluded that the benefits of Nerventra at the dose studied were not sufficient to outweigh the potential risks in patients with relapsing remitting MS and maintained its recommendation that the medicine be refused marketing authorisation.
Slovenian: Zato je zaključil, da koristi zdravila Nerventra pri proučevanem odmerku niso bile zadostne, da bi odtehtale možna tveganja pri bolnikih z recidivno-remitentno MS, in potrdil priporočilo, da se zanj zavrne dovoljenje za promet.
English: The company informed the CHMP that there are a number of ongoing and planned clinical trials with Nerventra in patients with multiple sclerosis.
Slovenian: Družba je odbor CHMP obvestila, da poteka oziroma se načrtuje več kliničnih preskušanj zdravila Nerventra pri bolnikih z multiplo sklerozo.
English: Refusal of the marketing authorisation for Nerventra (laquinimod) EMA/311892/2014
Slovenian: Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Nerventra (lakinimod) EMA/405473/2014
English: Nerventra was to be used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Slovenian: Zdravilo Nerventra naj bi se uporabljalo za vrsto MS, imenovano recidivno-remitentna MS, pri kateri ima bolnik napade (recidive) simptomov, ki jim sledijo obdobja izboljšanja (remisije).
English: What was Nerventra expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Nerventra uporabljalo?
English: How is Nerventra expected to work?
Slovenian: Kako naj bi zdravilo Nerventra delovalo?
English: control the inflammation and the damage to nerves, thus helping to reduce symptoms and the worsening of disability in patients with MS.
Slovenian: Z uravnavanjem delovanja imunskega sistema naj bi pomagalo zmanjšati vnetje in poškodbe živcev, s čimer naj bi ublažilo simptome in upočasnilo napredovanje prizadetosti pri bolnikih z MS.
English: What measures are being taken to ensure the safe and effective use of
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe
English: EMA/510659/2015
Slovenian: EMA/510659/2015 EMEA/H/C/003776
English: The maximum dose is 12 tablets per day.
Slovenian: Največji odmerek je 12 tablet na dan.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom spojino, ki se izloči z blatom.
English: Other information about Fexeric
Slovenian: Druge informacije o zdravilu Fexeric
English: The full EPAR and risk management plan summary for Fexeric 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) in povzetek načrta obvladovanja tveganj za zdravilo Fexeric sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In the second study, 149 patients who were not on dialysis received either Fexeric or placebo for 3 months.
Slovenian: V drugi študiji je 149 bolnikov, ki niso bili na dializi, tri mesece prejemalo zdravilo Fexeric ali placebo.
English: What is Fexeric and what is it used for?
Slovenian: Kaj je zdravilo Fexeric in za kaj se uporablja?
English: Serious side effects were uncommon and mainly affected the gut and stomach.
Slovenian: Resni neželeni učinki so bili občasni in so večinoma prizadeli črevo ter želodec.
English: This is a summary of the European public assessment report (EPAR) for Fexeric.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fexeric.
English: A risk management plan has been developed to ensure that Fexeric is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Fexeric je bil pripravljen načrt obvladovanja tveganj.
English: What are the risks associated with Fexeric?
Slovenian: Kakšna tveganja so povezana z zdravilom Fexeric?