FrancophonIA/ELRC3.0 huggingface dataset:
English: tuberculosis or fungal infections, the doctor may recommend a lower starting dose.
Slovenian: Pri bolnikih, ki jemljejo določena zdravila, vključno z zdravili za zdravljenje okužb z virusom HIV, tuberkuloze ali glivičnih okužb, lahko zdravnik priporoči manjši začetni odmerek.
English: For the full list of side effects with Adempas, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Adempas, glejte navodilo za uporabo.
English: • Pulmonary arterial hypertension (PAH, where the walls of the blood vessels of the lungs are thickened and the vessels become narrowed).
Slovenian: • pljučno arterijsko hipertenzijo (PAH, tj. boleznijo, pri kateri se krvne žile v pljučih zožijo zaradi zadebeljenih sten teh žil).
English: How does Adempas work?
Slovenian: Kako zdravilo Adempas deluje?
English: Treatment with the established dose should continue unless patients experience signs and symptoms of low blood pressure, in which case the dose should be reduced.
Slovenian: Največji odmerek ne sme preseči 2,5 mg trikrat na dan. Zdravljenje z določenim odmerkom je treba nadaljevati, če bolnik nima znakov in simptomov nizkega krvnega tlaka.
English: Route of Administration Immediate Packaging Pack size
Slovenian: Pot uporabe Stična ovojnina Velikost pakiranja
English: Results from this study also showed a decrease in the number of cataplexy attacks.
Slovenian: Rezultati te študije so pokazali tudi zmanjšanje števila napadov katapleksije.
English: Wakix pitolisant
Slovenian: Wakix pitolizant
English: Wakix is available as tablets (4.5 and 18 mg).
Slovenian: Zdravilo Wakix je na voljo v obliki tablet (4,5 in 18 mg).
English: Serious but rare side effects are abnormal loss of weight and spontaneous abortion.
Slovenian: Resna, vendar redka neželena učinka sta nenormalna izguba teže in spontani splav.
English: During the first week of treatment, the recommended dose is 9 mg per day, taken in the morning during breakfast.
Slovenian: Prvi teden zdravljenja znaša priporočeni odmerek 9 mg na dan in se vzame zjutraj med zajtrkom.
English: In addition, Wakix works differently from currently available treatments and therefore offers an alternative treatment option.
Slovenian: Poleg tega zdravilo Wakix deluje drugače kot trenutno razpoložljiva zdravljenja in zato ponuja nadomestno možnost zdravljenja.
English: The most common side effects with Wakix (which may affect up to 1 in 10 people) are insomnia (difficulty sleeping), headache, nausea (feeling sick), anxiety, irritability, dizziness, depression, tremor, sleep disorders, tiredness, vomiting, vertigo (a spinning sensation) and dyspepsia (heartburn).
Slovenian: Najpogostejši neželeni učinki zdravila Wakix (ki lahko prizadenejo več kot 1 osebo od 10) so nespečnost (težave s spanjem), glavobol, navzeja (slabost), tesnoba, razdražljivost, omotica, depresija, tremor, motnje spanja, utrujenost, bruhanje, vrtoglavica (občutek vrtenja) in dispepsija (zgaga).
English: This leads to symptoms such as an irresistible urge to sleep, even at inappropriate times and places, and disturbed night-time sleep.
Slovenian: To lahko povzroči simptome, kot sta nezadržna potreba po spanju, tudi ob neprimernem času in na neprimernem mestu, in moteno spanje ponoči.
English: This increases the activity of certain brain cells called ‘histamine neurons', which are important for keeping the body awake.
Slovenian: To zviša dejavnost določenih možganskih celic, imenovanih „histaminski nevroni“, ki so pomembni pri ohranjanju budnosti telesa.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Wakix's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zato zaključil, da so koristi zdravila Wakix večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Wakix?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Wakix?
English: Wakix should always be used at the lowest effective dose.
Slovenian: Zdravilo Wakix je treba uporabljati v najmanjšem učinkovitem odmerku.
English: Some patients also have episodes of severe muscle weakness (cataplexy) that can cause collapse.
Slovenian: Nekateri bolniki imajo tudi epizode hude mišične oslabelosti (katapleksijo), zaradi katere se lahko bolnik zgrudi.
English: This is a summary of the European public assessment report (EPAR) for Wakix.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Wakix.
English: Wakix has been investigated in 2 main studies involving a total of 261 adults with narcolepsy, the majority of whom also had cataplexy.
Slovenian: Zdravilo Wakix so proučevali v dveh glavnih študijah, pri katerih je sodelovalo skupno 261 odraslih z narkolepsijo, od katerih je večina imela tudi katapleksijo.
English: The safety profile of Wakix is considered acceptable, with no major safety concerns identified.
Slovenian: Varnostni profil zdravila Wakix je bil ocenjen kot sprejemljiv, saj ni bilo ugotovljenih večjih varnostnih zadržkov.
English: Other information about Wakix
Slovenian: Druge informacije o zdravilu Wakix
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Wakix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote za zdravilo Wakix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: A risk management plan has been developed to ensure that Wakix is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Wakix je bil pripravljen načrt obvladovanja tveganj.
English: In patients with moderately reduced liver function or with kidney problems, the maximum dose should be 18 mg per day.
Slovenian: Pri bolnikih z zmerno zmanjšanim delovanjem jeter ali težavami z ledvicami je lahko največji odmerek 18 mg na dan.
English: This is a standard scale used in patients with narcolepsy which ranges from 0 to 24.
Slovenian: To je standardna lestvica z razponom od 0 do 24, ki se uporablja pri bolnikih z narkolepsijo.
English: Narcolepsy is a long-term sleep disorder which affects the brain's ability to regulate the normal sleep-wake cycle.
Slovenian: Narkolepsija je dolgotrajna motnja spanja, ki vpliva na zmožnost možganov, da bi uravnavali normalen cikel spanja in budnosti.
English: The second study, however, did not show a difference between Wakix and placebo at reducing sleepiness or cataplexy.
Slovenian: Druga študija pa ni pokazala razlike med zdravilom Wakix in placebom pri zmanjšanju zaspanosti ali katapleksije.
English: Because the number of patients with narcolepsy is low, the disease is considered ‘rare', and Wakix was designated an ‘orphan medicine' (a medicine used in rare diseases) on 10 July 2007.
Slovenian: Ker je bolnikov z narkolepsijo malo, velja ta bolezen za redko, zato je bilo zdravilo Wakix 10. julija 2007 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: The overall data available demonstrate that Wakix has a positive effect on the two major symptoms of narcolepsy, excessive daytime sleepiness and cataplexy.
Slovenian: Skupni razpoložljivi podatki kažejo, da ima zdravilo Wakix pozitivne učinke na dva glavna simptoma narkolepsije, tj. čezmerno dnevno zaspanost in katapleksijo.
English: In a further study in 105 patients with narcolepsy and cataplexy, Wakix was also more effective than placebo at reducing the number of cataplexy attacks per week: the number of cataplexy attacks decreased from around 9 to around 3 per week in patients taking Wakix, while it remained at around 7 per week in patients taking placebo.
Slovenian: V nadaljnji študiji 105 bolnikov z narkolepsijo in katapleksijo je bilo zdravilo Wakix tudi učinkovitejše od placeba pri zmanjševanju števila napadov katapleksije na teden: število napadov katapleksije se je zmanjšalo s približno devet na tri na teden pri bolnikih, ki so jemali zdravilo Wakix, medtem ko je ostalo pri približno sedmih napadih na teden pri bolnikih, ki so jemali placebo.
English: In addition, the company that markets Wakix will carry out an observational study to collect information on the safety of the medicine when used in medical practice.
Slovenian: Poleg tega bo podjetje, ki trži to zdravilo, izvedlo opazovalno študijo, da bi zbralo informacije o njegovi varnosti, kadar se uporablja v klinični praksi.
English: The active substance in Wakix, pitolisant, works by attaching to receptors in the brain called ‘histamine H3 receptors'.
Slovenian: Zdravilna učinkovina zdravila Wakix, pitolizant, deluje tako, da se veže na receptorje v možganih, imenovane „histaminski receptorji H3“.
English: When looking at sleepiness with an objective test called Maintenance of Wakefulness Test or MWT, the results of the two studies together showed that Wakix significantly improved wakefulness compared with placebo.
Slovenian: Če zaspanost merimo z objektivnim testom, imenovanim test srednjega trajanja budnosti (TSTB), pa rezultati obeh študij skupaj kažejo, da je zdravilo Wakix znatno izboljšalo budnost v primerjavi s placebom.
English: Wakix is a medicine used to treat adults with narcolepsy.
Slovenian: Zdravilo Wakix se uporablja za zdravljenje odraslih z narkolepsijo.
English: What is Wakix and what is it used for?
Slovenian: Kaj je zdravilo Wakix in za kaj se uporablja?
English: What benefits of Wakix have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Wakix izkazalo v študijah?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Wakix, 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: What are the risks associated with Wakix?
Slovenian: Kakšna tveganja so povezana z zdravilom Wakix?
English: For more information about treatment with Wakix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Wakix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Wakix is used in patients with or without cataplexy.
Slovenian: Zdravilo Wakix se uporablja pri bolnikih s katapleksijo ali brez nje.
English: The full EPAR and risk management plan summary for Wakix 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 Wakix sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Why is Wakix approved?
Slovenian: Zakaj je bilo zdravilo Wakix odobreno?
English: The first study showed that Wakix was more effective than placebo at reducing daytime sleepiness: patients taking Wakix had an average reduction of 3 points more in the ESS scale than those taking placebo after 8 weeks of treatment.
Slovenian: Prva študija je pokazala, da je bilo zdravilo Wakix učinkovitejše od placeba pri zmanjševanju dnevne zaspanosti: pri bolnikih, ki so osem tednov prejemali zdravilo Wakix, se je vrednost na lestvici ELZ v povprečju zmanjšala za tri točke več kot pri tistih, ki so jemali placebo.
English: Wakix must not be used in patients with severely reduced liver function and in women who are breastfeeding.
Slovenian: Zdravila ne smejo uporabljati bolniki z močno zmanjšanim delovanjem jeter ali ženske, ki dojijo.
English: The main measure of effectiveness was based on how sleepy patients felt during daytime, assessed using the Epworth Sleepiness Scale or ESS.
Slovenian: Glavno merilo učinkovitosti je temeljilo na oceni, kako zaspani so se bolniki počutili čez dan, za kar so uporabili Epworthovo lestvico zaspanosti (ELZ).
English: For practical information about using Wakix, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Wakix naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: It is not intended to provide practical advice on how to use Wakix.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: During the second week of treatment, the dose can be increased to 18 mg per day or decreased to 4.5 mg per day.
Slovenian: Drugi teden zdravljenja se odmerek lahko poveča na 18 mg na dan ali zmanjša na 4,5 mg na dan. Tretji teden zdravljenja pa se odmerek lahko poveča na največji odmerek 36 mg na dan.
English: The studies compared Wakix with placebo (a dummy treatment).
Slovenian: V študijah so zdravilo Wakix primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: Wakix can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of sleep disorders.
Slovenian: Izdaja zdravila Wakix je le na recept, zdravljenje pa mora uvesti zdravnik z izkušnjami z zdravljenjem motenj spanja.
English: For the full list of all side effects reported with Wakix, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Wakix, glejte navodilo za uporabo.
English: Wakix contains the active substance pitolisant.
Slovenian: Zdravilo vsebuje zdravilno učinkovino pitolizant.
English: How does Wakix work?
Slovenian: Kako zdravilo Wakix deluje?
English: How is Wakix used?
Slovenian: Kako se zdravilo Wakix uporablja?
English: 31 July 2014
Slovenian: 31. julij 2014
English: The referral started on 6 November 2013.
Slovenian: Napotitveni postopek se je začel 6. novembra 2013.
English: The final opinion was converted into a Decision by the European Commission on 31 July 2014.
Slovenian: Končno mnenje je bilo 31. julija 2014 spremenjeno v sklep Evropske komisije.
English: The Committee appointed E. Persson as rapporteur and A. Wachnik-Święcicka as co-rapporteur.
Slovenian: Odbor je za poročevalko imenoval E. Persson, za soporočevalko pa A. Wachnik-Święcicka.
English: International non-proprietary name (INN): tylosin
Slovenian: Mednarodno nelastniško ime (INN): tilozin
English: The CVMP was requested to consider whether tylosin is still effective against swine dysentery (caused by Brachyspira hyodysenteriae) and whether the treatment durations beyond three weeks are justified.
Slovenian: Odbor CVMP so zaprosili, naj prouči, ali je tilozin še učinkovit proti prašičji dizenteriji (ki jo povzroča Brachyspira hyodysenteriae) in ali je trajanje zdravljenja, daljše od treh tednov, upravičeno.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.
Slovenian: Seznam zadevnih imen zdravila je v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s spremembami povzetkov glavnih značilnosti zdravila, označevanja in navodilom za uporabo v Prilogi III.
English: Written comments on the recommendations and proposed changes in the product information were provided by the applicants and marketing authorisation holders on 7 March 2014.
Slovenian: Predlagatelji in imetniki dovoljenja za promet z zdravilom so 7. marca 2014 podali pisne pripombe na priporočila in predlagane spremembe informacij o zdravilu.
English: On 30 October 2013, Sweden presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs.
Slovenian: Švedska je 30. oktobra 2013 agenciji predložila obvestilo o napotitvi v skladu s členom 35 Direktive 2011/82/ES za zdravila za uporabo v veterinarski medicini, ki vsebujejo tilozin in se dajejo peroralno v krmo ali vodo za pitje prašičev.
English: Therefore, on 8 May 2014 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs.
Slovenian: Zato je 8. maja 2014 soglasno sprejel pozitivno mnenje, v katerem je priporočil spremembo pogojev dovoljenj za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo tilozin in se dajejo peroralno v krmo ali vodo za pitje prašičev.
English: referral for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs
Slovenian: za zdravila za uporabo v veterinarski medicini, ki vsebujejo tilozin in se dajejo peroralno v krmo ali vodo za pitje prašičev
English: Opinion following an Article 35 referral for veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs EMA/492247/2014
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 35 za zdravila za uporabo v veterinarski medicini, ki vsebujejo tilozin in se dajejo peroralno v krmo ali vodo za pitje prašičev
English: blister (PVC/PE/PVDC/alu) calendar
Slovenian: Pretisni omot (PVC/PE/PVDC/alu) Dnevi v tednu
English: The National Competent Authorities in each Member State shall discuss and agree with the Marketing Authorisation Holder (MAH ) measures to enhance further the monitoring of patients treated with Tysabri (e.g. registries, post-marketing surveillance studies) as appropriate and must ensure that the MAH implements the agreed measures within an agreed time frame.
Slovenian: Nacionalne agencije v vsaki državi članici se morajo z imetnikom dovoljenja za promet z zdravilom dogovoriti o podrobnostih za boljši nadzor bolnikov, ki se zdravijo z zdravilom Tysabri (npr. registri, opazovalne študije po prihodu zdravila na trg), kot je ustrezno, in zagotoviti, da imetnik dovoljenja za promet z zdravilom dogovorjene ukrepe izvede v dogovorjenem časovnem okviru.
English: The Marketing Authorisation provides all physicians who intend to prescribe TYSABRI with a physician pack containing the following elements:
Slovenian: Imetnik dovoljenja za promet z zdravilom oskrbi vse zdravnike, ki nameravajo predpisovati zdravilo TYSABRI, s paketom za zdravnike, ki vsebuje naslednje elemente:
English: The Member States shall discuss and agree the physician pack with the MAH and ensure that:
Slovenian: Države članice se bodo z imetnikom dovoljenja za promet z zdravilom dogovorile o paketu za zdravnike in zagotovile, da:
English: The treatment continuation form should contain the elements of the treatment initiation form and, in addition, a statement that the risks of PML increase with duration of treatment and that treatment beyond 24 months carries additional risk.
Slovenian: Obrazec za nadaljevanje zdravljenja mora vsebovati elemente obrazca za začetek zdravljenja, poleg tega pa še navedbo, da tveganje za PML narašča s trajanjem zdravljenja ter da zdravljenje, ki traja dlje kot 24 mesecev, predstavlja še dodatno tveganje.
English: • Confirmation of patient understanding of the risks of PML and that they have received a copy of the form and a patient alert card
Slovenian: • potrditev, da bolnik razume tveganje za PML in da je prejel kopijo obrazca in kartico s posebnimi opozorili
English: • Confirmation that the doctor has discussed the risks of PML and the risk of IRIS if treatment is discontinued following suspicion of PML
Slovenian: • potrditev, da se je zdravnik z bolnikom pogovoril o tveganju za PML ter tveganju za IRIS, če se zdravljenje prekine zaradi suma na PML
English: • Patient alert card
Slovenian: • Kartico s posebnimi opozorili za bolnika
English: A copy of the treatment initiation form A patient alert card including a core text agreed by the CHMP o If treatment is to be continued for longer than 24 months, the need to inform patients about the increased risk of PML and provide them with a copy of the treatment continuation form o The need to inform the National Competent Authority about any cases of PML
Slovenian: o Če naj bi zdravljenje trajalo dlje kot 24 mesecev, zahtevo, da se bolnike obvesti o povečanem tveganju za razvoj PML in se jim da kopijo obrazca za nadaljnje zdravljenje o Zahtevo, da se nacionalni pristojni organ obvesti o vseh primerih PML
English: • Information on PML and IRIS including the risk of developing PML during Tysabri treatment stratified by prior treatment with immunosuppressants and JC virus infection.
Slovenian: TYSABRI, opredeljeno glede na predhodno zdravljenje z imunosupresivi in okužbo z virusom JC
English: • Information that atypical/opportunistic infections, and in particular PML, may occur with TYSABRI and include: o That the risk of PML increases with increasing duration of treatment and that treatment beyond 24 months carries additional risk o Other factors associated with an increased risk for the development of PML Immunosuppressant treatment prior to the use of Tysabri Presence of anti-JC virus antibodies o A stratification of the risk of developing PML based on the three identified risk factors o Diagnosis of PML including differentiation between PML and MS relapse o PML management algorithm o Possibility of other opportunistic infections o The recommendation that patients should have MRI scans at the following times Within 3 months prior to starting TYSABRI Annually during treatment with TYSABRIi At the first sign of any symptoms indicative of the possibility of PML.
Slovenian: • Informacijo, da se lahko pri uporabi zdravila TYSABRI pojavijo atipične/oportunistične okužbe, zlasti PML, vključno z: o da tveganje za PML narašča s trajanjem zdravljenja in da zdravljenje, ki traja dlje kot 24
English: o The need to inform patients about the benefits and risk of TYSABRI and provide them with:
Slovenian: enkrat letno med zdravljenjem z zdravilom TYSABRI ob prvih znakih kakršnih koli simptomov, ki kažejo na možnost pojava PML o Zahtevo, da se bolnike obvesti o koristih in tveganjih zdravljenja z zdravilom TYSABRI in se jim da:
English: 1 Article 29(2) of Directive 2001/83/EC, as amended.
Slovenian: 1 Člen 29(2) of Direktive 2001/83/ES, kot je bila spremenjena.
English: The Reference Member State was Finland and the Concerned Member States were Belgium, Germany, Luxembourg and the Netherlands.
Slovenian: Referenčna država članica je bila Finska, zadevne države članice pa so bile Belgija, Nemčija, Luksemburg in Nizozemska.
English: The Concerned Member States have not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Slovenian: Zadevne države članice niso mogle doseči soglasja v zvezi z medsebojnim priznavanjem dovoljenja za promet z zdravilom, ki ga je podelila referenčna država članica.
English: The application was withdrawn in the Netherlands and Germany referred the reasons for disagreement to the EMEA on 15 December 2004.
Slovenian: Vloga je bila umaknjena na Nizozemskem in Nemčija je 15. decembra 2004 Evropski agenciji za zdravila podala razloge za nesoglasje.
English: During its June 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for
Slovenian: Na sestanku v juniju 2005, je CHMP glede na vse predložene podatke ter znanstveno razpravo znotraj Odbora menil, da je razmerje med koristmi in tveganji za zdravilo Lansopon ugodno.