FrancophonIA/ELRC3.0 huggingface dataset:
English: 100 mg / 150 mg Film-coated tablet Oral use blister (PCTFE/PVC/alu)
Slovenian: 100 mg / 150 mg filmsko obložena tableta peroralna uporaba pretisni omot (PCTFE/PVC alu)
English: Route of Administrati on
Slovenian: Pot uporabe Stična ovojnina
English: The recommended dose is 14 mg once a day.
Slovenian: Priporočeni odmerek je 14 mg enkrat na dan.
English: The results of the study were inconclusive.
Slovenian: Rezultati študije so bili nejasni.
English: The study lasted for up to two years.
Slovenian: Študija je trajala do dve leti.
English: Treatment lasted for up to about three years (152 weeks).
Slovenian: Zdravljenje je trajalo približno tri leta (152 tednov).
English: Aubagio teriflunomide
Slovenian: Aubagio teriflunomid
English: • serious infections;
Slovenian: • z resnimi okužbami;
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aubagio on 26 August 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Aubagio, veljavno po vsej Evropski uniji, izdala 26. avgusta 2013.
English: • severe immunodeficiency states, such as acquired immune deficiency syndrome (AIDS);
Slovenian: • s stanji hude imunske pomanjkljivosti, kot je sindrom pridobljene imunske pomanjkljivosti (aids);
English: Women who can become pregnant must not take Aubagio without using reliable contraceptive measures.
Slovenian: Ženske, ki lahko zanosijo, ne smejo jemati zdravila Aubagio, če ne uporabljajo zanesljive kontracepcijske zaščite.
English: The full EPAR for Aubagio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Aubagio je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: • severe hypoproteinaemia (low blood protein levels).
Slovenian: • s hudo hipoproteinemijo (nizkimi ravnmi beljakovin v krvi).
English: Aubagio must not be used in patients with:
Slovenian: Zdravila Aubagio ne smejo uporabljati bolniki:
English: Aubagio is available as tablets (14 mg).
Slovenian: Zdravilo Aubagio je na voljo v obliki tablet (14 mg).
English: What measures are being taken to ensure the safe and effective use of Aubagio?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Aubagio?
English: This is a summary of the European public assessment report (EPAR) for Aubagio.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Aubagio.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Aubagio'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 zaključil, da so koristi zdravila Aubagio večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Other information about Aubagio
Slovenian: Druge informacije o zdravilu Aubagio
English: • poor bone marrow function or low blood cell counts (red cells, white cells or platelets);
Slovenian: • z okvaro kostnega mozga ali majhnim številom krvnih celic (rdečih celic, belih celic ali trombocitov);
English: The risk of serious side effects affecting the liver and bone marrow was considered manageable and adequately addressed by risk minimisation measures.
Slovenian: Tveganje za resne neželene učinke, ki prizadenejo jetra in kostni mozeg, velja za obvladljivo in ga je mogoče ustrezno zmanjšati z ukrepi za zmanjšanje tveganja.
English: A risk management plan has been developed to ensure that Aubagio is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Aubagio je bil pripravljen načrt obvladovanja tveganj.
English: Regarding its safety, side effects were similar to the immunosuppressant leflunomide, as leflunomide is converted into teriflunomide in the body.
Slovenian: Glede varnosti zdravila so bili neželeni učinki podobni kot pri imunosupresivu leflunomidu, saj se leflunomid v telesu pretvori v teriflunomid.
English: It is used to treat adults with multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath around the nerves.
Slovenian: Uporablja se za zdravljenje odraslih z multiplo sklerozo (MS), tj. boleznijo, pri kateri vnetje uniči zaščitno ovojnico okoli živcev.
English: Aubagio is a medicine that contains the active substance teriflunomide.
Slovenian: Aubagio je zdravilo, ki vsebuje zdravilno učinkovino teriflunomid.
English: In general, headache, diarrhoea, nausea and alopecia are mild to moderate, resolve with time and do not usually lead to treatment being stopped.
Slovenian: Glavobol, driska, navzeja in alopecija so običajno blagi do zmerni in po določenem času izginejo, zato običajno zaradi njih ni treba prekiniti zdravljenja.
English: The pack will also include information on a registry the company will set up to collect data on babies born to women treated with Aubagio, as well as a patient reminder card with key safety information for patients.
Slovenian: Gradivo bo vsebovalo tudi informacije o registru, ki ga bo družba vzpostavila, da bi zbrala podatke o dojenčkih, rojenih ženskam, ki so jemale zdravilo Aubagio, in opozorilno kartico za bolnike s ključnimi informacijami o varnosti.
English: Aubagio has been studied in four main studies involving over 2,700 adults with relapsing-remitting MS.
Slovenian: Zdravilo Aubagio so proučevali v štirih glavnih študijah, v katere je bilo vključenih več kot 2 700 odraslih z recidivno remitentno multiplo sklerozo.
English: The most commonly reported side effects with Aubagio (which may affect more than 1 in 10 people) are headache, diarrhoea, increased liver enzymes, nausea (feeling sick), and alopecia (hair loss).
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali pri uporabi zdravila Aubagio (ki lahko prizadenejo več kot 1 osebo od 10), so glavobol, driska, zvišane ravni jetrnih encimmov, navzeja (slabost) in alopecija (izpadanje las).
English: The exact way teriflunomide works in MS is not known but it is thought to reduce the number of lymphocytes which form part of the immune system and are involved in the inflammation process.
Slovenian: Natančen način delovanja teriflunomida pri multipli sklerozi ni znan, vendar se domneva, da zmanjša število limfocitov, ki so del imunskega sistema in sodelujejo pri vnetnem procesu.
English: What benefits of Aubagio have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Aubagio izkazalo v študijah?
English: What are the risks associated with Aubagio?
Slovenian: Kakšna tveganja so povezana z zdravilom Aubagio?
English: The active substance in Aubagio, teriflunomide, blocks an enzyme called ‘dihydro-orotate dehydrogenase' which is necessary for cells to multiply.
Slovenian: Zdravilna učinkovina zdravila Aubagio, teriflunomid, zavira encim, imenovan „dihidroorotat-dehidrogenaza“, ki ga celice potrebujejo za razmnoževanje.
English: Although the effects were modest, they were considered to be significant and similar to other MS treatments, although there were no conclusive results available from a direct comparison with interferon beta-1a.
Slovenian: Čeprav so bili učinki skromni, so bili pomembni in podobni kot pri drugih zdravilih za zdravljenje multiple skleroze, čeprav neposredna primerjava z interferonom beta-1a ni prinesla dokončnih rezultatov.
English: In addition, the company that markets Aubagio must ensure that all healthcare professionals who are expected to use Aubagio receive an information pack containing important safety information, including the tests and monitoring that should be carried out in patients before and after starting treatment.
Slovenian: Poleg tega mora družba, ki trži zdravilo Aubagio, poskrbeti, da bodo vsi zdravstveni delavci, ki naj bi uporabljali to zdravilo, prejeli informativno gradivo, ki bo vsebovalo pomembne informacije o varnosti, vključno z informacijami o preiskavah in spremljanju, ki so potrebni pred uvedbo zdravljenja in po njegovem začetku.
English: What is Aubagio and what is it used for?
Slovenian: Kaj je zdravilo Aubagio in za kaj se uporablja?
English: For more information about treatment with Aubagio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Aubagio preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Overall, no conclusion could be reached from this study on any differences between Aubagio and interferon beta-1a for MS treatment.
Slovenian: Na splošno na podlagi te študije ni bilo mogoče podati zaključkov o razlikah med zdravilom Aubagio in interferonom beta-1a pri zdravljenju multiple skleroze.
English: • severe kidney disease that requires dialysis;
Slovenian: • s hudim obolenjem ledvic, zaradi katerega je potrebna dializa;
English: The fourth study involving 324 patients compared the effects of Aubagio with interferon beta-1a (another treatment for MS) on the rate of treatment failure, by looking at the time until patients had their first relapse or permanently stopped their treatment.
Slovenian: V četrti študiji s 324 bolniki so primerjali učinke zdravila Aubagio in interferona beta-1a (drugega zdravila za zdravljenje multiple skleroze) na stopnjo neuspešnosti zdravljenja, pri čemer so spremljali, koliko časa je preteklo do prvega recidiva pri bolnikih ali do trajne prekinitve zdravljenja.
English: Why is Aubagio approved?
Slovenian: Zakaj je bilo zdravilo Aubagio odobreno?
English: It is not intended to provide practical advice on how to use Aubagio.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: For practical information about using Aubagio, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Aubagio naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: One study involving 179 patients compared the effects of Aubagio with placebo (a dummy treatment) on the number of active lesions (developing areas of damage) in the brain detected by a brain scan.
Slovenian: V eni študiji s 179 bolniki so primerjali učinke zdravila Aubagio in placeba (zdravila brez zdravilne učinkovine) na število aktivnih lezij (področij, kjer nastajajo poškodbe) v možganih, ki so jih odkrili s slikanjem možganov.
English: Two studies involving 2,257 patients compared the effects of Aubagio with placebo in reducing the number of relapses per patient per year (called the ‘annualised relapse rate').
Slovenian: V dveh študijah s 2 257 bolniki so primerjali učinke zdravila Aubagio in placeba na zmanjšanje števila recidivov na bolnika na leto (t. i. „letna stopnja recidivov“).
English: However, the rate of relapse was 23.4% with Aubagio compared with 15.4% with interferon beta-1a.
Slovenian: Vendar pa je bila stopnja recidivov pri zdravilu Aubagio 23,4 %, pri interferonu beta-1a pa 15,4 %.
English: Aubagio can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the management of MS.
Slovenian: Izdaja zdravila Aubagio je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem multiple skleroze.
English: For the full list of all side effects reported with Aubagio, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Aubagio, glejte navodilo za uporabo.
English: The studies also looked at the effect of Aubagio on the changes in the patients' level of disability and showed that the risk of disability getting worse was reduced by 30% in comparison with placebo after around two and a half years (132 weeks) of treatment.
Slovenian: V študijah so proučevali tudi učinek zdravila Aubagio na spremembo stopnje nezmožnosti bolnikov in ugotovili, da se je po dveh letih in pol (132 tednih) zdravljenja tveganje za poslabšanje nezmožnosti zmanjšalo za 30 % v primerjavi s placebom.
English: Aubagio must also not be used in pregnant women or during breast-feeding.
Slovenian: Prav tako ga ne smejo uporabljati nosečnice in ženske, ki dojijo.
English: Aubagio is given by mouth which was considered to be an advantage over other medicines such as interferon beta-1a.
Slovenian: Zdravilo Aubagio se daje peroralno, kar je njegova prednost v primerjavi z drugimi zdravili, na primer interferonom beta-1a.
English: Aubagio was found to be more effective than placebo: in patients taking Aubagio, relapses were reduced by around 30% more than in patients taking placebo (the annualised relapse rate was 0.35 for Aubagio compared with 0.53 for placebo).
Slovenian: Ugotovili so, da je zdravilo Aubagio učinkovitejše od placeba: pri bolnikih, ki so jemali zdravilo Aubagio, so zabeležili za približno 30 % večje zmanjšanje števila recidivov kot pri bolnikih, ki so jemali placebo (letna stopnja recidivov pri zdravilu Aubagio je bila 0,35, pri placebu pa 0,53).
English: With fewer lymphocytes, there is less inflammation, helping to control the symptoms of MS.
Slovenian: Z zmanjšanjem števila limfocitov se zmanjša tudi vnetje, kar pripomore k obvladovanju simptomov multiple skleroze.
English: Aubagio is 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 Aubagio se uporablja pri vrsti multiple skleroze, imenovane recidivno remitentna multipla skleroza, pri kateri ima bolnik napade (recidive) simptomov, ki jim sledijo obdobja izboljšanja (remisije).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aubagio, 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 uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Aubagio was found to be more effective than placebo: after around 9 months (36 weeks), the number of active lesions was around 1 per scan in patients who were taking Aubagio compared with around 2.7 in patients taking placebo.
Slovenian: Ugotovili so, da je zdravilo Aubagio učinkovitejše od placeba: po približno devetih mesecih (36 tednih) so pri bolnikih, ki so jemali zdravilo Aubagio, opazili približno eno aktivno lezijo na sliko, pri bolnikih, ki so jemali placebo, pa približno 2,7.
English: How does Aubagio work?
Slovenian: Kako zdravilo Aubagio deluje?
English: A 13.5% rate of permanent discontinuation was seen in patients taking Aubagio, compared with 24% in patients taking interferon beta-1a.
Slovenian: Pri bolnikih, ki so jemali zdravilo Aubagio, je bila stopnja trajne prekinitve zdravljenja 13,5 %, pri bolnikih, ki so jemali interferon beta-1a, pa 24 %.
English: How is Aubagio used?
Slovenian: Kako se zdravilo Aubagio uporablja?
English: • severe liver disease;
Slovenian: • s hudim obolenjem jeter;
English: In studies, Aubagio was shown to reduce relapses and delay the progression of disability in patients with relapsingremitting MS.
Slovenian: V študijah je zdravilo Aubagio pri bolnikih z recidivno remitentno multiplo sklerozo zmanjšalo število recidivov in upočasnilo napredovanje njihove nezmožnosti.
English: You may watch television.
Slovenian: Lahko gledate televizijo.
English: Date of first authorisation: 24 October 2001 Date of latest renewal: 22 September 2011
Slovenian: Datum prve odobritve: 24. oktober 2001 Datum zadnjega podaljšanja: 22. september 2011
English: Your doctor will also tell you what to do.
Slovenian: Tudi vaš zdravnik vam bo povedal, kako morate ravnati.
English: No other interactions have been observed.
Slovenian: Drugih interakcij niso opazili.
English: Of these, 6 had a complete local response according to WHO criteria.
Slovenian: Od teh jih je 6 doseglo popoln lokalni odziv po kriterijih Svetovne zdravstvene organizacije.
English: Plasma protein binding is at 85-87 %.
Slovenian: Vezava na plazemske proteine je okoli 85 -87 %.
English: Tel.: +49 3641 5195330 Fax: +49 3641 5195331
Slovenian: Tel.: +49 49 3641 5195330 Faks: +49 3641 5195331
English: The use of headlamps is recommended instead.
Slovenian: Namesto njih priporočajo uporabo naglavnih svetilk.
English: You must follow these instructions carefully.
Slovenian: Teh navodil se morate natančno držati.
English: The following information is intended for medical or healthcare professionals only
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju
English: The type of clothes you must wear are:
Slovenian: Nositi morate sledeče vrste oblačil:
English: Start on Day 8 with 10-15 minutes outdoors.
Slovenian: Začnite 8. dan z 10-15 minutami na prostem.
English: For treatment of other types of pain listed in this section, please see section 4.4.
Slovenian: Za zdravljenje drugih vrst bolečine, ki so navedene v tem poglavju, glejte poglavje 4.4.
English: • You will gradually become less sensitive to light.
Slovenian: • Postopoma boste postali manj občutljivi za svetlobo.
English: You must get out of the light immediately.
Slovenian: Takoj se morate umakniti s svetlobe.
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnosti, ki so navedene spodaj, so opredeljene z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti (≥1/100 < do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000), neznano (ni mogoče oceniti iz razpoložljivih podatkov).
English: • Sunscreen creams will not prevent this sensitivity.
Slovenian: • Kreme za sončenje ne bodo pomagale pri tej vrsti občutljivosti.
English: Wait 24 hours to see if there is any redness.
Slovenian: Počakajte 24 ur, da vidite, ali se pojavi rdečina.
English: The laser light is not hot and will not burn.
Slovenian: Laserska svetloba ni vroča in ne peče.
English: Days 8-14
Slovenian: Dnevi 8-14
English: Appropriate precaution must be taken when handling this medicinal product.
Slovenian: Pri ravnanju s tem zdravilom je potrebna ustrezna previdnost.
English: Oximeters must be repositioned at least every 10-15 minutes to avoid the risk of local skin burns.
Slovenian: Oksimetre je potrebno prestavljati vsaj vsakih 10 do 15 minut, da se izognemo tveganju za lokalne opekline na koži.
English: Your eyes may be very sensitive to bright lights during this week.
Slovenian: Vaše oči so lahko v tem tednu zelo občutljive na močno svetlobo.
English: The median observed duration of tumour response for all patients was 57 days for overall response and 84 days for complete response.
Slovenian: Srednja vrednost trajanja odziva tumorja za vse bolnike je bila 57 dni za celoten odziv in 84 dni za popoln odziv.
English: • Do not wear very thin clothing because it will not protect you from strong light.
Slovenian: • Ne nosite zelo tankih oblačil, saj vas ne bodo zaščitila pred močno svetlobo.
English: What should I do to prevent burns?
Slovenian: Kaj moram storiti, da se izognem opeklinam?
English: You can increase your exposure by another 15 minutes each day i.e. second day 30 minutes, third day 45 minutes, fourth day 60 minutes and so on.
Slovenian: Vsak dan lahko povečate izpostavljenost neposredni sončni svetlobi za 15 minut, to pomeni 30 minut drugi dan, 45 minut tretji dan, 60 minut četrti dan in tako naprej.
English: Days 2-7
Slovenian: Dnevi 2-7
English: If you have this problem, wear dark glasses.
Slovenian: Če boste imeli takšne težave, nosite sončna očala.
English: These effects may make it difficult to eat and drink.
Slovenian: Zaradi teh neželenih učinkov boste mogoče s težavo jedli in pili.
English: Do not use this medicine after the expiry date which is stated on the label and the carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki in škatli.
English: Stay in shaded areas or go out when it is cloudy.
Slovenian: Zadržujte se v senci ali pojdite ven v oblačnem vremenu.
English: Pain occurs the day after illumination and usually lasts 2 to 4 weeks.
Slovenian: Bolečine se pojavijo naslednji dan po obsevanju in navadno trajajo 2 do 4 tedne.
English: The amount of alcohol in this product may alter the effects of other medicines.
Slovenian: Količina alkohola v tem zdravilu lahko spremeni učinke drugih zdravil.
English: Do not stay in the sunlight for more than 15 minutes the first time.
Slovenian: Prvič ne ostanite na sončni svetlobi več kot 15 minut.
English: Furthermore you will probably notice swelling and reddening around the area that has been treated.
Slovenian: Poleg tega boste verjetno opazili otekanje in pordečitev okrog zdravljenega predela.
English: • Please speak to your doctor about this before you go home after being injected with Foscan.
Slovenian: • Prosimo, da se o tem pogovorite z zdravnikom, še preden greste domov po injiciranju zdravila Foscan.
English: Women of childbearing potential have to use effective contraception during and up 3 months after treatment.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in do 3 mesece po njem.
English: This product is also harmful for those suffering from alcoholism.
Slovenian: To zdravilo je tudi škodljivo za tiste, ki trpijo za alkoholizmom.
English: A WHO local complete response was observed in 14 % of patients.
Slovenian: Popoln lokalni odziv po WHO (Svetovna zdravstvena organizacija) so opazili pri 14 % bolnikov.
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: Stay in the shade.
Slovenian: Zadržujte se v senci.
English: Proactively managing the local effects and diminishing photoactivation in non-tumour areas is important to manage the risks.
Slovenian: Aktivno zdravljenje lokalnih učinkov in zmanjševanje fotoaktivacije v netumorskih območjih je pomembno pri upravljanju tveganj.
English: • These instructions are written in this leaflet.
Slovenian: • Navodila so napisana v tem Navodilu za uporabo.
English: You may be given some medicine to reduce the swelling.
Slovenian: Mogoče boste dobili kakšno zdravilo za zmanjšanje otekline.
English: Events occurring at a frequency not known (frequency cannot be estimated from the available data):
Slovenian: Neželeni učinki, ki se pojavljajo z neznano pogostnostjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
English: Single dose.
Slovenian: Enojni odmerek.
English: 5 years Once opened, the solution must be used immediately.
Slovenian: 5 let Odprto raztopino je treba takoj uporabiti.
English: It is important that patients are re-introduced to normal light gradually (see the light protection guidelines for patients at the end of this section).
Slovenian: Pomembno je, da se bolniki spet postopoma ponovno privajajo na normalno svetlobo (glejte smernice za zaščito pred svetlobo za bolnike na koncu tega poglavja).
English: Thirty-seven patients received at least 2 treatments with Foscan.
Slovenian: 37 bolnikov je prejelo vsaj 2 odmerka zdravila Foscan.
English: Foscan will be stored at the hospital pharmacy.
Slovenian: Zdravilo Foscan bo shranjeno v bolnišnični lekarni.
English: Most people will be able to go back to their normal routine by Day 22.
Slovenian: Večina ljudi se bo lahko po 22. dnevu vrnila v normalni ritem življenja.