FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients who respond to Duloxetine Mylan, treatment should continue for several months, to prevent the disorder coming back.
Slovenian: Pri bolnikih, ki se odzovejo na zdravilo Duloksetin Mylan, naj bi zdravljenje potekalo več mesecev, da se prepreči ponoven pojav bolezni.
English: Because Duloxetine Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Cymbalta.
Slovenian: Ker je zdravilo Duloksetin Mylan generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Cymbalta.
English: For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of 120 mg per day.
Slovenian: Pri zdravljenju bolečine diabetične nevropatije je priporočeni odmerek 60 mg na dan, nekateri bolniki pa bodo morda potrebovali višji odmerek, in sicer 120 mg na dan.
English: Because Duloxetine Mylan is a generic medicine of Cymbalta, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Duloksetin Mylan generično zdravilo, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Duloxetine Mylan contains the active substance duloxetine and is a ‘generic medicine'.
Slovenian: Zdravilo Duloksetin Mylan vsebuje zdravilno učinkovino duloksetin in je „generično zdravilo“.
English: Therefore, the CHMP's view was that, as for Cymbalta, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Cymbalta odtehtajo znana tveganja.
English: Other information about Duloxetine Mylan
Slovenian: Druge informacije o zdravilu Duloksetin Mylan
English: The active substance in this medicine, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Slovenian: Zdravilna učinkovina v zdravilu Duloksetin Mylan, duloksetin, je zaviralec ponovnega prevzema serotonina in noradrenalina.
English: The dose of Duloxetine Mylan should be reduced gradually when stopping treatment.
Slovenian: Ob prenehanju zdravljenja je treba odmerek zdravila Duloksetin Mylan zmanjševati postopoma.
English: What is Duloxetine Mylan and what is it used for?
Slovenian: Kaj je zdravilo Duloksetin Mylan in za kaj se uporablja?
English: Why is Duloxetine Mylan approved?
Slovenian: Zakaj je bilo zdravilo Duloksetin Mylan odobreno?
English: It is not intended to provide practical advice on how to use Duloxetine Mylan.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: How is Duloxetine Mylan used?
Slovenian: Kako se zdravilo Duloksetin Mylan uporablja?
English: How has Duloxetine Mylan been studied?
Slovenian: Kako je bilo zdravilo Duloksetin Mylan raziskano?
English: How does Duloxetine Mylan work?
Slovenian: Kako zdravilo Duloksetin Mylan deluje?
English: It is used in the following ways:
Slovenian: Uporablja se:
English: In patients who cannot drink it can be given by a tube into the stomach.
Slovenian: Pri bolnikih, ki je ne morejo popiti, se lahko daje po cevki v želodec.
English: GABA reduces the electrical activity of the brain.
Slovenian: GABA zmanjšuje električno dejavnost možganov.
English: The company provided information from the published literature on the benefits and risks of vigabatrin in the approved uses.
Slovenian: Podjetje je predstavilo podatke iz objavljene literature o koristih in tveganjih vigabatrina pri odobrenih uporabah.
English: Further information on Kigabeq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Kigabeq so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other common side effects include psychiatric disorders such as agitation, excitedness, aggression, nervousness, depression and paranoid reactions, as well as reduced consciousness and confusion.
Slovenian: Drugi pogosti neželeni učinki so duševne motnje, kot so vznemirjenost, razdražljivost, agresivnost, živčnost, depresija in paranoične reakcije ter motnje zavesti in zmedenost.
English: This helps suppress the abnormal electrical activity that leads to infantile spasms and partial epilepsy, and so controls the symptoms of these conditions.
Slovenian: To pomaga zavirati nenormalno električno dejavnost, ki vodi v infantilne spazme in parcialno epilepsijo, ter s tem nadzoruje simptome teh stanj.
English: The dose depends on the condition being treated and the patient's body weight, and is adjusted according to the patient's response to treatment.
Slovenian: Odmerek je odvisen od zdravljene bolezni in bolnikove telesne mase ter se prilagaja skladno z bolnikovim odzivom na zdravljenje.
English: • on its own to treat infantile spasms (West syndrome), a rare epilepsy disorder that starts at a very young age, usually in the first few months of life;
Slovenian: • samostojno za zdravljenje infantilnih spazmov (Westovega sindroma), redke epileptične motnje, ki se začne zelo zgodaj v otroštvu, običajno v prvih nekaj mesecih življenja;
English: Kigabeq is a medicine for treating epilepsy in children between 1 month and 7 years of age.
Slovenian: Kigabeq je zdravilo, ki se uporablja za zdravljenje epilepsije pri otrocih, starih od enega meseca do sedmih let.
English: Kigabeq is only used in partial epilepsy when patients have already tried all other appropriate treatments or cannot use them because of side effects.
Slovenian: Zdravilo Kigabeq se pri parcialni epilepsiji uporablja le, kadar so bolniki že preizkusili vsa druga ustrezna zdravila ali jih ne morejo uporabljati zaradi neželenih učinkov.
English: • together with other medicines to treat partial epilepsy (seizures affecting one part of the brain), including when the seizures spread to other parts of the brain and become more generalised.
Slovenian: • skupaj z drugimi zdravili za zdravljenje parcialne epilepsije (epileptičnih napadov, ki prizadenejo del možganov), tudi pri razširitvi epileptičnih napadov na druge dele možganov in njihovi generalizaciji.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Kigabeq is available in a different form and strengths.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki vsebuje enako učinkovino, vendar je zdravilo Kigabeq na voljo v drugačni obliki in drugačnih jakostih.
English: What measures are being taken to ensure the safe and effective use of Kigabeq?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kigabeq?
English: Blocking the enzyme that breaks it down increases the amount of GABA present in the brain, and so increases its effect.
Slovenian: Zaviranje encima, ki jo razgrajuje, poveča količino snovi GABA v možganih in tako poveča njen učinek.
English: The tablets are dissolved in water to make a solution for the patient to drink.
Slovenian: Tablete je treba raztopiti v vodi, da se pripravi raztopina, ki jo bolniki lahko popijejo.
English: The most common side effects with vigabatrin (which may affect more than 1 in 10 people) are visual field defects (effects on vision), tiredness, sleepiness and joint pains.
Slovenian: Najpogostejši neželeni učinki vigabatrina (ki se lahko pojavijo pri več kot 1 bolniku od 10) so izpadi vidnega polja (učinki na vid), utrujenost, zaspanost in bolečine v sklepih.
English: Rarely there may be effects on the retina (the light-sensing layer at the back of the eye), encephalopathy (brain damage) or attempts at suicide.
Slovenian: Redko se lahko pojavijo učinki na mrežnico (plast na očesnem ozadju, ki zaznava svetlobo), encefalopatija (okvara možganov) ali poskusi samomora.
English: Side effects reported with Kigabeq are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Kigabeq, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: An overview of Kigabeq and why it is authorised in the EU
Slovenian: Pregled zdravila Kigabeq in zakaj je odobreno v EU
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kigabeq 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 Kigabeq upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Why is Kigabeq authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Kigabeq odobreno v EU?
English: The European Medicines Agency decided that in accordance with EU requirements, Kigabeq has been shown to have comparable quality and to be bioequivalent to Sabril.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Kigabeq primerljivo raven kakovosti in je bioekvivalentno zdravilu Sabril.
English: The reference medicine for Kigabeq is Sabril (500 mg granules).
Slovenian: Referenčno zdravilo zdravila Kigabeq je zdravilo Sabril (500-miligramske granule).
English: The active substance in Kigabeq, vigabatrin, blocks the action of an enzyme called GABA transaminase, which breaks down a substance in the brain called GABA (gamma aminobutyric acid).
Slovenian: Učinkovina v zdravilu Kigabeq, vigabatrin, zavira delovanje encima, imenovanega GABA-transaminaza, ki razgrajuje snov v možganih, imenovano GABA (γ-aminomaslena kislina).
English: Because the effects on vision can lead to blindness, vigabatrin should only be used after careful assessment of possible alternatives, and patients' vision must be regularly tested during treatment.
Slovenian: Ker lahko učinki na vid povzročijo slepoto, se sme vigabatrin uporabljati le po skrbni oceni možnih nadomestnih zdravil, med zdravljenjem pa je treba redno preverjati bolnikov vid. Vigabatrin se ne sme uporabljati pri bolnikih, ki že imajo izpade vidnega polja.
English: What benefits of Kigabeq have been shown in studies?
Slovenian: Kakšne koristi zdravila Kigabeq so se pokazale v študijah?
English: For more information about using Kigabeq, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Kigabeq glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The medicine is available as soluble tablets of 100 or 500 mg, with a score-line so they can be halved.
Slovenian: Zdravilo je na voljo v obliki 100-miligramskih ali 500-miligramskih tablet za peroralno raztopino.
English: Other information about Kigabeq
Slovenian: Druge informacije o zdravilu Kigabeq
English: As for all medicines, data on the use of Kigabeq are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Kigabeq stalno spremljajo.
English: What is Kigabeq and what is it used for?
Slovenian: Kaj je zdravilo Kigabeq in za kaj se uporablja?
English: Kigabeq contains the active substance vigabatrin and is a ‘hybrid medicine'.
Slovenian: Zdravilo Kigabeq vsebuje učinkovino vigabatrin in je „hibridno zdravilo“.
English: As for every medicine, the company provided studies on the quality of Kigabeq.
Slovenian: Tako kot za vsako zdravilo je predložilo študije o kakovosti zdravila Kigabeq.
English: It also carried out a study that showed that Kigabeq is bioequivalent to the reference medicine, Sabril.
Slovenian: Izvedlo je tudi študijo, ki je pokazala, da je zdravilo Kigabeq „bioekvivalentno“ referenčnemu zdravilu Sabril.
English: What are the risks associated with Kigabeq?
Slovenian: Kakšna tveganja so povezana z zdravilom Kigabeq?
English: Kigabeq can only be obtained with a prescription and treatment must started and supervised by a doctor specialising in the treatment of epilepsy or nervous system disorders.
Slovenian: Predpisovanje in izdaja zdravila Kigabeq je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik specialist za zdravljenje epilepsije ali bolezni živčevja.
English: For the full list of side effects and restrictions with Kigabeq, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Kigabeq glejte navodilo za uporabo.
English: Therefore, the Agency's view was that, as for Sabril, Kigabeq's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Zato je menila, da koristi zdravila Kigabeq enako kot pri zdravilu Sabril odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
English: How is Kigabeq used?
Slovenian: Kako se zdravilo Kigabeq uporablja?
English: How does Kigabeq work?
Slovenian: Kako zdravilo Kigabeq deluje?
English: The horses should be revaccinated every year.
Slovenian: Konje je treba vsako leto znova cepiti.
English: This summary was last updated on 05/08/2011.
Slovenian: Povzetek je bil nazadnje posodobljen dne 05/08/2011.
English: In all studies the vaccinated horses were compared with horses that were not vaccinated.
Slovenian: V vseh študijah so cepljene konje primerjali s konji, ki niso bili cepljeni.
English: Protection starts four weeks after the first injection and lasts for a year.
Slovenian: Zaščita nastopi štiri tedne po prvi injekciji in traja eno leto.
English: They may also have a temporary swelling at the injection site which usually disappears within four days.
Slovenian: Na mestu injiciranja se lahko pojavi tudi začasna oteklina, ki pa v štirih dneh običajno izgine.
English: The vaccine also contains an ‘adjuvant' to enhance the immune response.
Slovenian: Cepivo vsebuje tudi „adjuvans“ za povečanje imunskega odziva.
English: The first injection is given from five months of age and the second injection is given four to six weeks later.
Slovenian: Prva injekcija se da pri starosti pet mesecev ali več, druga pa štiri do šest tednov kasneje.
English: The vaccine was tested in nine laboratory studies in horses from five months of age.
Slovenian: Cepivo je bilo preizkušeno v devetih laboratorijskih študijah pri konjih, starih pet mesecev ali več.
English: This document is a summary of the European Public Assessment Report.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR).
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption.
Slovenian: Karenca je časovno obdobje, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in se meso ali jajca ali mleko uporabi za prehrano ljudi.
English: Horses vaccinated with Proteq West Nile may have a slightly raised body temperature (up to 1.5°C) lasting up to two days.
Slovenian: Konji, cepljeni z zdravilom Proteq West Nile, bodo morda do dva dni imeli povišano telesno temperaturo (do 1,5 °C).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Proteq West Nile to MERIAL on 05/08/2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Proteq West Nile, veljavno po vsej Evropski uniji, odobrila družbi MERIAL dne 05/08/2011.
English: West Nile recombinant canarypox virus (vCP2017 virus)
Slovenian: West Nile rekombinantni Canarypox virus (virus vCP2017)
English: The studies showed that the vaccine prevents viraemia in horses and reduces clinical signs in horses infected with West Nile virus.
Slovenian: Študije so pokazale, da cepivo preprečuje viremijo pri konjih in zmanjšuje klinične znake pri konjih, okuženih z virusom West Nile.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Slovenian: Razmerje med koristmi in tveganji najdete v znanstveni razpravi tega evropskega javnega poročila o oceni zdravila (EPAR).
English: The vaccine is given to young horses as two injections into the neck muscles.
Slovenian: Cepivo se mladim konjem injicira v vratno mišico v dveh odmerkih.
English: Other information about Proteq West Nile:
Slovenian: Druge informacije o zdravilu Proteq West Nile:
English: Proteq West Nile is a vaccine.
Slovenian: Zdravilo Proteq West Nile je cepivo.
English: The main measure of effectiveness was based on the number of horses who had viraemia or clinical signs of West Nile disease.
Slovenian: Glavno merilo učinkovitosti je bilo število konjev, ki so imeli viremijo ali klinične znake bolezni West Nile.
English: For a full list of the side-effects reported with Proteq West Nile, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Proteq West Nile, glejte navodilo za uporabo.
English: When a horse is given the vaccine, the immune system recognises the West Nile proteins PreM and E as ‘foreign' and makes antibodies against it.
Slovenian: Ko konje cepimo, njihov imunski sistem prepozna beljakovini PreM in E v virusu West Nile kot „ tujka“ ter proti njima razvije protitelesa.
English: What benefit has Proteq West Nile shown during the studies?
Slovenian: Kakšne koristi je zdravilo Proteq West Nile izkazalo med študijami?
English: The CVMP therefore concluded that the benefits of Proteq West Nile exceed the risks for the vaccination of horses from 5 months of age against West Nile disease and recommended that Proteq West Nile be given a marketing authorisation.
Slovenian: CVMP je tako zaključil, da so koristi zdravila Proteq West Nile večje od z njim povezanih tveganj pri cepljenju konjev, starih pet mesecev ali več, proti bolezni West Nile, in priporočil odobritev dovoljenja za promet z zdravilom Proteq West Nile.
English: The vaccine strain vCP2017 in Proteq West Nile is a ‘carrier' canarypox virus that has been given a gene that makes it able to produce part of the West Nile virus, the proteins PreM and E. The canarypox viruses do not spread or multiply in the vaccinated horses.
Slovenian: Sev cepiva vCP2017 v zdravilu Proteq West Nile je „prenašalec“ virusa Canarypox z dodanim genom, ki omogoča tvorjenje dela virusa West Nile, in sicer beljakovin PreM in E. Virusi Canarypox se pri cepljenih konjih ne širijo ali razmnožujejo.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) considered that Proteq West Nile is generally well tolerated and useful in reducing clinical outbreaks of West Nile disease.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je menil, da konji zdravilo Proteq West Nile na splošno dobro prenašajo in da je zdravilo koristno pri zmanjševanju kliničnih izbruhov bolezni West Nile.
English: If someone accidentally injects themselves with the medicine, the person should seek medical advice immediately and show the package leaflet or label to the doctor.
Slovenian: Ob nenamernem samoinjiciranju zdravila se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali nalepko na zunanji ovojnini.
English: In the future, the immune system will be able to produce antibodies more quickly when it is exposed to West Nile virus, and this helps to protect against mortality due to West Nile disease.
Slovenian: Ob ponovni izpostavitvi virusu West Nile v prihodnosti bo imunski sisteme hitreje izdelal protitelesa, kar bo prispevalo k zaustavitvi smrtnosti zaradi bolezni West Nile.
English: What is the risk associated with Proteq West Nile?
Slovenian: Kakšna tveganja so povezana z zdravilom Proteq West Nile?
English: Proteq West Nile is used to protect horses from 5 months of age against West Nile disease.
Slovenian: Zdravilo Proteq West Nile se uporablja za zaščito konj, starih pet mesecev ali več, pred boleznijo West Nile.
English: Proteq West Nile is a vaccine that contains West Nile recombinant canarypox virus (vCP2017 virus).
Slovenian: Zdravilo Proteq West Nile je cepivo, ki vsebuje West Nile rekombinantni Canarypox virus (virus vCP2017).
English: Why has Proteq West Nile been approved?
Slovenian: Zakaj je bilo zdravilo Proteq West Nile odobreno?
English: West Nile disease is a mosquito-borne viral disease that can cause encephalitis (inflammation of the brain) and meningitis (inflammation of the lining of the brain and spinal cord).The vaccine is used to reduce the number of horses with the West Nile virus in their blood (viraemia) or with clinical signs of the disease.
Slovenian: Bolezen West Nile je virusna bolezen, ki jo prenašajo komarji ter lahko povzroča encefalitis (vnetje možganov) in meningitis (vnetje ovojnice možganov in hrbtenjače).
English: How has Proteq West Nile been studied?
Slovenian: Kako je bilo zdravilo Proteq West Nile raziskano?
English: What is Proteq West Nile?
Slovenian: Kaj je zdravilo Proteq West Nile?
English: What is Proteq West Nile used for?
Slovenian: Za kaj se zdravilo Proteq West Nile uporablja?
English: How does Proteq West Nile work?
Slovenian: Kako zdravilo Proteq West Nile deluje?
English: Note: P values in the table are nominal.
Slovenian: Opomba: vrednosti P v preglednici so nominalne.
English: (See the end of section 2 - Important information about the contents of Orkambi.)
Slovenian: (Glejte konec poglavja 2 - Pomembne informacije o vsebini zdravila Orkambi.)
English: As such, risks to the suckling child cannot be excluded.
Slovenian: Tveganja za dojenega otroka ne moremo izključiti.
English: The Applicant should submit yearly analyses from December 2017 to 2020 and the final CSR by December 2021.
Slovenian: Predlagatelj naj predloži letne analize od decembra 2017 do 2020 in končno CSR do decembra 2021.
English: The apparent terminal half-life is approximately 26 hours.
Slovenian: Navidezni končni razpolovni čas je približno 26 ur.
English: If this is not possible, give it within the hour after mixing.
Slovenian: Če to ni možno, mu jo dajte znotraj ene ure po pripravi mešanice.
English: Juvenile animals
Slovenian: Mlade živali
English: † Indicates statistical significance confirmed in the hierarchical testing procedure.
Slovenian: †Pomeni statistično signifikantnost, potrjeno s hierarhičnim postopkom testiranja.
English: No data are available (see section 5.1).
Slovenian: Podatkov ni na voljo (glejte poglavje 5.1).
English: Following this period, the recommended daily dose should be continued.
Slovenian: Po tem obdobju se mora nadaljevati priporočeni dnevni odmerek.
English: Respiratory events
Slovenian: Respiratorni dogodki
English: Majority of patients discontinued for reasons other than safety.
Slovenian: Večina bolnikov je izstopila iz študije zaradi drugih razlogov, ne zaradi varnosti.
English: The significance of these findings for humans is unknown.
Slovenian: Pomen teh ugotovitev za ljudi ni znan.
English: Make sure that the mixture is consumed immediately and completely.
Slovenian: Zagotovite, da bo otrok mešanico zaužil v celoti in takoj.
English: Approximately three-quarters of the events began during the first week of treatment, and in most patients the events resolved without dosing interruption.
Slovenian: Približno tri četrtine dogodkov se je začelo med prvim tednom zdravljenja in pri večini bolnikov so se dogodki razrešili brez prekinitve odmerjanja.
English: Treatment of overdose consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Slovenian: Zdravljenje prevelikega odmerka sestavljajo splošni podporni ukrepi, vključno s spremljanjem vitalnih znakov in opazovanjem kliničnega stanja bolnika.
English: 1 sachet per day or less frequently
Slovenian: 1 vrečica na dan ali manj pogosto
English: All other drug interactions shown are predicted.
Slovenian: Vse druge interakcije med zdravili so napovedane.
English: * Trial included key secondary and other secondary endpoints.
Slovenian: * Preskušanje je vključevalo ključne sekundarne in druge sekundarne cilje.
English: An alternative confirmatory method should be considered to verify results.
Slovenian: Za preverjanje rezultatov premislite o alternativni potrditveni metodi.
English: † From Trials 1, 2 and 3.
Slovenian: † Iz preskušanj 1, 2 in 3.
English: In some instances, these elevations have been associated with concomitant elevations in total serum bilirubin.
Slovenian: V nekaterih primerih so bila ta zvišanja povezana s sočasnim zvišanjem celotnega serumskega bilirubina.