FrancophonIA/ELRC3.0 huggingface dataset:
English: Benlysta given by infusion was shown to be more effective than placebo (a dummy treatment) in reducing disease activity when used as an add-on treatment for SLE in two main studies involving 1,693 adult patients with active SLE.
Slovenian: V dveh glavnih študijah, ki sta vključevali 1 693 odraslih bolnikov z aktivnim sistemskim eritematoznim lupusom, je bilo dokazano, da je zdravilo Benlysta, dano z infundiranjem, pri zmanjševanju bolezenske dejavnosti učinkovitejše od placeba (zdravila brez učinkovine), kadar se uporablja kot dodatno zdravilo proti sistemskemu eritematoznemu lupusu.
English: How does Benlysta work?
Slovenian: Kako zdravilo Benlysta deluje?
English: Ref. EMEA/CHMP/744722/2009 rev. EMEA/H/A-29/1170
Slovenian: : EMEA/CHMP/744722/2009 rev. EMEA/H/A-29/1170
English: Company responses provided on: 27 August 2009, 26 October 2009 Opinion date:
Slovenian: Odgovori družbe predloženi dne: 27. avgusta 2009, 26. oktobra 2009 Datum izdaje mnenja:
English: Questions and answers on the referral for Pantoprazole Olinka pantoprazole 20 and 40 mg tablets
Slovenian: Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Pantoprazole Olinka pantoprazol 20 in 40 mg tablete
English: The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Pantoprazole Olinka.
Slovenian: Evropska agencija za zdravila (EMEA) je končala postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije glede odobritve zdravila Pantoprazole Olinka.
English: The 20 mg tablets can be used for reflux disease to treat symptoms such as heartburns and acid regurgitation (acid flowing up in the mouth), for the long-term management and prevention of relapse in reflux oesophagitis (inflammation of the gullet, due to acid), for the prevention of the stomach ulcers that can be caused by some medicines used to treat pain and inflammations called non-selective non-steroidal anti-inflammatory drugs (NSAIDs), when the patient needs continuous NSAID treatment.
Slovenian: 20-miligramske tablete se lahko uporabljajo za lajšanje simptomov refluksa, kot sta zgaga in regurgitacija kisline (vračanje kisline v usta), za dolgoročno zdravljenje in preprečevanje ponovne pojavitve refluksnega ezofagitisa (vnetje požiralnika zaradi kisline), za preprečevanje razjed na želodcu, ki jih lahko povzročajo nekatera zdravila za lajšanje bolečin in vnetij, imenovana neselektivna nesteroidna protivnetna zdravila (NSAID), kadar potrebuje bolnik stalno zdravljenje z NSAID.
English: Why was Pantoprazole Olinka reviewed?
Slovenian: Zakaj je bilo zdravilo Pantoprazole Olinka pregledano?
English: The 40 mg tablets can be used for more severe acid diseases such as stomach ulcer, duodenal ulcer, Zollinger-Ellison syndrome (a condition caused by oversecretion of acid in the stomach) and to help rid the stomach of a bacterium called Helicobacter pylori, which is known to cause stomach ulcer.
Slovenian: 40-miligramske tablete se lahko uporabljajo za zdravljenje hujših obolenj zaradi kisline, kot so razjede na želodcu in dvanajstniku, Zollinger-Ellisonovega sindroma (stanja, ki nastane zaradi čezmernega izločanja kisline v želodcu) in za pomoč pri odstranitvi bakterije Helicobacter pylori iz želodca, za katero je znano, da povzroča razjedo na želodcu
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Pantoprazole Olinka outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the European Union, Germany and Poland.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMEA je zaključil, da koristi zdravila Pantoprazole Olinka odtehtajo njegova tveganja in da se lahko dovoljenje za promet z zdravilom odobri v Združenem kraljestvu ter tudi v naslednjih državah članicah Evropske unije: v Nemčiji in na Poljskem.
English: This is a procedure when one Member State (the ‘reference Member State', in this instance the UK) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘concerned Member States', in this instance Germany and Poland).
Slovenian: za promet z njim, ki bo veljavno v tej državi in v drugih državah članicah (v „zadevnih državah članicah“, v tem primeru v Nemčiji in na Poljskem).
English: The review was carried out under an ‘Article 29' referral1.
Slovenian: 1po členu 29.
English: Pharmaceutical form Route of administration Packaging Content
Slovenian: Številka EU zaščiteno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja EU/1/97/040/001 Teslascan 0,01 mmol/ml Raztopina za infundiranje Intravenska uporaba Viala (iz stekla) 50 ml
English: This risk appears to be higher in children.
Slovenian: Videti je, da je to tveganje večje pri otrocih.
English: Children aged less than 18 years should not take this medicine.
Slovenian: Otroci, mlajši od 18 let, ne smejo jemati tega zdravila.
English: Therefore this information is of limited value.
Slovenian: Zato ima ta informacija majhno vrednost.
English: Elderly patients (over 65 years of age)
Slovenian: Starejši bolniki (nad 65 let)
English: Modafinil was first authorized in the EU in France, in June 1992.
Slovenian: Modafinil je bil v EU najprej odobren v Franciji junija leta 1992.
English: The expiry date refers to the last day of the month.
Slovenian: Rok uporabnosti se nanaša na zadnji dan meseca.
English: It is currently licensed in 21 countries in Europe, and the approved indications vary between Member States.
Slovenian: Trenutno je odobreno v 21 državah v Evropi, vendar se odobrene indikacije med državami članicami razlikujejo.
English: The efficacy in the long term has also not been demonstrated.
Slovenian: Dolgoročna učinkovitost prav tako ni bila dokazana.
English: Common: decreased appetite
Slovenian: Pogosti: zmanjšan apetit
English: Data should be submitted once it is available from the investigators.
Slovenian: Podatke je treba predložiti, ko jih bodo raziskovalci dali na voljo.
English: Misuse and illicit use accounted for less than 3% of posted messages online.
Slovenian: Napačna in nedovoljena uporaba sta predstavljali manj kot 3 % na spletu objavljenih sporočil.
English: • The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing modafinil.
Slovenian: • Odbor je upošteval napotitev v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo modafinil.
English: Aggressive or hostile behaviour
Slovenian: Agresivno ali sovražno vedenje
English: • This medicine has the potential for you to become reliant (dependent) on it after long-term use.
Slovenian: • To zdravilo ima potencial, da se nanj navadite (postanete odvisni) po dolgotrajni uporabi.
English: Take this leaflet and any remaining tablets with you.
Slovenian: S seboj prinesite to navodilo in vse preostale tablete.
English: As the Committee's assessment of the safety information did not change following re-examination, the Product Information remained unchanged.
Slovenian: Ker se ocena varnostnih informacij Odbora po ponovnem pregledu ni spremenila, informacije o zdravilu ostajajo nespremenjene.
English: Statistically significant differences were seen in the subjective parameters (ESS and CGI-C).
Slovenian: Statistično pomembne razlike so ugotovili pri subjektivnih parametrih (ESS in CGI-C).
English: Overall benefit/risk assessment
Slovenian: Splošna ocena koristi in tveganj
English: However the effect size is small and does not necessarily reflect a clinically significant benefit.
Slovenian: Vendar je velikost učinka majhna in ne odraža nujno klinično pomembne koristi.
English: You may want to consider asking a family member or close friend to help you look out for signs of depression or other changes in your behaviour.
Slovenian: Družinskega člana ali dobrega prijatelja lahko prosite, naj vam pomaga paziti na znake depresije ali druge spremembe vedenja.
English: The benefit-risk balance in this indication is therefore considered to be positive under the normal conditions of use.
Slovenian: Razmerje med koristmi in tveganji za to indikacijo se zato pri normalnih pogojih uporabe šteje za pozitivno.
English: This is usually mild or moderate, dose-dependent and disappears within a few days.
Slovenian: Ta je navadno blag ali zmeren, odvisen od odmerka in izgine v nekaj dneh.
English: Your doctor in some cases may decide to increase your daily dose up to 400 mg.
Slovenian: V nekaterih primerih se vaš zdravnik lahko odloči, da poveča vaš dnevni odmerek na do 400 mg.
English: Other side effects include the following:
Slovenian: Drugi neželeni učinki vključujejo naslednje:
English: • You feel any change in your mental health and wellbeing.
Slovenian: • čutite spremembo v duševnem zdravju ali počutju.
English: The Committee considered that further risk minimisation measures would not adequately address the concern as the magnitude of the risk is not fully determined.
Slovenian: Odbor je menil, da dodatni ukrepi za zmanjševanje tveganje ne bi ustrezno obravnavali težave, saj obseg tveganja ni popolnoma ugotovljen.
English: Improvements were also noted in the subjective measurements.
Slovenian: Izboljšave so opazili tudi pri subjektivnih meritvah.
English: • Misinterpretation of the risks associated to modafinil
Slovenian: • Napačna interpretacija tveganj, povezanih z modafinilom.
English: Idiopathic Hypersomnia
Slovenian: Idiopatska hipersomnija
English: These differences, although statistically significant, are very small and therefore its clinical significance is questioned.
Slovenian: Čeprav so te razlike statistično pomembne, so po drugi strani zelo majhne, zato je njihov klinični pomen vprašljiv.
English: The study is intended to be initiated in September 2010 and the final report will be submitted in 4Q2011.
Slovenian: Začetek študije je načrtovan za september 2010, končno poročilo pa bo predloženo v zadnjem četrtletju leta 2011.
English: Tell your doctor straight away if you notice that you are becoming depressed, feel aggressive or hostile towards other people or have suicidal thoughts or other changes in your behaviour (see section 4).
Slovenian: Takoj povejte zdravniku, če opazite, da postajate depresivni, ste agresivni ali sovražni do drugih ljudi ali imate samomorilne misli ali spremembe v vedenju (glejte poglavje 4).
English: This is further illustrated by the fact that patients at the end of the trial were sufficiently sleepy to meet the entrance criteria for the study (MSLT<6 minutes).
Slovenian: To potrjuje dejstvo, da so bili bolniki na koncu preskušanja dovolj zaspani, da so izpolnili vstopna merila za študijo (MSLT <6 minut).
English: Sleepiness associated with narcolepsy is the only indication approved in all Member States where the product is approved.
Slovenian: Zaspanost, povezana z narkolepsijo, je edina indikacija, odobrena v vseh državah članicah, kjer je zdravilo odobreno.
English: • You notice a skin rash or itching (especially if it affects your whole body).
Slovenian: • opazite izpuščaj na koži ali srbenje (zlasti če prizadene celotno telo).
English: Three of these had a fatal outcome, and for the majority, causality could not be excluded.
Slovenian: Trije primeri so se končali s smrtnim izidom, za večino pa ni bilo možno izključiti vzročnosti.
English: Suicide-related behaviour
Slovenian: S samomorom povezano vedenje
English: Steps to ensure good sleep hygiene may include a review of caffeine intake.
Slovenian: Koraki za vzdrževanje dobre spalne higiene lahko vključujejo pregled vnosa kofeina.
English: • Have any heart problems or high blood pressure.
Slovenian: • če imate težave s srcem ali visok krvni tlak.
English: Data presented in support of this indication includes a total of 6 patients, of which at least 2 actually presented with excessive sleepiness due to sleep apnoea.
Slovenian: Podatki, predstavljeni v podporo tej indikaciji, vključujejo skupno 6 bolnikov, od katerih sta vsaj dva dejansko imela čezmerno zaspanost zaradi apneje med spanjem.
English: Stop taking this medicine and tell your doctor straight away if
Slovenian: Takoj prekinite jemanje tega zdravila in obvestite zdravnika, če:
English: You may also have a high temperature (fever) and abnormal blood test results.
Slovenian: Prav tako imate lahko visoko temperaturo (vročino) in nenormalne rezultate krvnih preiskav;
English: • Have kidney or liver problems (because you will need to take a lower dose).
Slovenian: • če imate težave z ledvicami ali jetri (ker boste morali jemati manjši odmerek);
English: The study should be started within 2 months of the Commission Decision, and the final report should be submitted within 6 months of study initiation.
Slovenian: Študija se mora začeti v 2 mesecih po sprejetju odločbe Komisije, končno poročilo pa mora biti predloženo v 6 mesecih po začetku študije.
English: If you need to take it for a long time your doctor will check regularly that it is still the best medicine for you.
Slovenian: Če ga morate jemati dlje časa, bo vaš zdravnik redno preverjal, ali je to še vedno najboljše zdravilo za vas.
English: For patients 6 to 7 years of age, the estimated half-life is approximately 7 hours and increases with increase in age until half-life values approach those in adults (approximately 15 hours).
Slovenian: Pri bolnikih, starih od 6 do 7 let, je ocenjen razpolovni čas približno 7 ur in se povečuje s starostjo, dokler se vrednosti razpolovnega časa ne približajo vrednostim pri odraslih (približno 15 ur).
English: Food has no effect on overall modafinil bioavailability; however, absorption (tmax) may be delayed by approximately one hour if taken with food.
Slovenian: Hrana nima nobenega vpliva na splošno biološko uporabnost modafinila, vendar pa se lahko absorpcija (tmax) upočasni za približno eno uro, če se vzame s hrano.
English: A diagnosis of narcolepsy should be made according to the International Classification of Sleep Disorders (ICSD2) guideline.
Slovenian: Diagnozo narkolepsije je treba postaviti skladno s smernico Mednarodne klasifikacije spalnih motenj (International Classification of Sleep Disorders - ICSCD 2).
English: Modafinil should not be used in children aged less than 18 years old because of safety and efficacy concerns (see section 4.4).
Slovenian: Modafinil naj se ne uporablja pri otrocih, mlajših od 18 let, zaradi pomislekov glede varnosti in učinkovitosti (glejte poglavje 4.4).
English: In view of the potential for lower clearance and increased systemic exposure, it is recommended that patients over 65 years of age commence therapy at 100 mg daily.
Slovenian: Glede na možnost manjšega očistka in povečane sistemske izpostavljenosti se priporoča, da se zdravljenje pri bolnikih, starejših od 65 let, začne z odmerkom 100 mg na dan.
English: It is therefore appropriate that treatment with modafinil always starts with the lowest recommended dose (200 mg) and be increased up to 400 mg only in patients with insufficient response.
Slovenian: Zato je primerno, da se zdravljenje z modafinilom vedno začne z najmanjšim priporočenim odmerkom (200 mg) in se poveča do 400 mg le pri bolnikih z nezadostnim odzivom.
English: Luxembourg ORGANON N.V Kloosterstraat 6
Slovenian: Luksemburg ORGANON N.V Kloosterstraat 6
English: Whilst studies with modafinil have demonstrated a potential for dependence, the possibility of dependence with long-term use cannot be entirely excluded.
Slovenian: Glede na to, da so študije modafinila pokazale potencial za odvisnost, možnosti odvisnosti pri dolgotrajni uporabi ni mogoče popolnoma izključiti.
English: Temporal association also contributes to the confirmation of causality.
Slovenian: Časovna povezava ravno tako prispeva k potrditvi vzročnosti.
English: The most commonly reported adverse drug reaction is headache, affecting approximately 21% of patients.
Slovenian: Neželeni učinek zdravila, o katerem so poročali najpogosteje, je glavobol, ki je prizadel približno 21 % bolnikov.
English: Psychotic or manic symptoms
Slovenian: Psihotični ali manični simptomi
English: Further consideration will be given to the use of databases in other EU countries, such as the Institute for Drug Outcomes Research (PHARMO) in the Netherlands and Cegedim in France.
Slovenian: Preučili bodo tudi zbirke podatkov v drugih državah EU, kot sta inštitut za raziskavo vpliva zdravil (Institute for Drug Outcomes Research, PHARMO) na Nizozemskem in Cegedim v Franciji.
English: Modafinil may improve your narcolepsy and reduce the likelihood that you will have sleep attacks but there may still be other ways that you can improve your condition and your doctor will advise you.
Slovenian: Modafinil lahko izboljša vašo narkolepsijo in zmanjša verjetnost, da boste imeli napade spanja, vendar pa obstajajo tudi drugi načini, da izboljšate svoje stanje, o čemer vam bo svetoval vaš zdravnik.
English: - Idiopathic hypersomnia (IH), approved in 4 Member States;
Slovenian: - idiopatsko hipersomnijo (IH) - odobrena v 4 državah članicah;
English: However, the clinical relevance of this increase is questionable as, at the end of the study, the patients would still be characterised as severely ill (severe illness according to ICSD-1 is usually associated to MSLT scores below 5).
Slovenian: Vendar je klinični pomen tega povečanja vprašljiv, saj bi bolnike na koncu študije še vedno lahko ocenili kot hudo bolne (huda bolezen je skladno z ICSD-1 običajno povezana z vrednostjo MSLT pod 5).
English: If the feasibility analysis shows that a scientifically valid, well-designed and suitable powered study is viable, then the MAHs commit to submit a detailed protocol within 2 months and to present the final study report within 6 months of completion of the study.
Slovenian: Če analiza izvedljivosti pokaže, da je znanstveno veljavna, dobro zasnovana in primerno močna študija možna, se imetniki dovoljenj za promet z zdravili zavezujejo k predložitvi podrobnega protokola v 2 mesecih ter končnega poročila o študiji v 6 mesecih po zaključku študije.
English: National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Slovenian: Nacionalni pristojni organi, ki jih po potrebi koordinira referenčna država članica, morajo zagotoviti, da imetniki dovoljenja za promet z zdravilom izpolnijo naslednje pogoje:
English: Patients should be advised that modafinil is not a replacement for sleep and good sleep hygiene should be maintained.
Slovenian: Bolnikom je treba povedati, da modafinil ni nadomestilo za spanje in da je treba vzdrževati dobro spalno higieno.
English: Tablets should be swallowed whole with water.
Slovenian: Tablete je treba pogoltniti cele z vodo.
English: Significant safety issues identified during this review (skin and hypersensitivity reactions, cardiovascular events) require further study.
Slovenian: Pomembne varnostne težave, ugotovljene v tem pregledu (kožne in preobčutljivostne reakcije, srčnožilni dogodki), zahtevajo dodatne študije.
English: In the rat peri-post-natal study, modafinil concentration in milk was about 11.5 times higher than in plasma.
Slovenian: V peri-post-natalnih študijah podgan je bila koncentracija modafinila v mleku približno 11,5-krat višja kot v plazmi.
English: The key messages have been agreed with CHMP and each Member State will ensure that the relevant information is included in the translation in their National Language, as applicable.
Slovenian: CHMP je potrdil ključna sporočila, vse države članice pa bodo zagotovile, da bodo pomembne informacije vključene v prevodih v nacionalne jezike, če je smiselno potrebno.
English: Undesirable effects such as blurred vision or dizziness might also affect ability to drive (see section 4.8).
Slovenian: Neželeni učinki, kot sta zamegljen vid in omotica, prav tako lahko vplivajo na sposobnost upravljanja vozil (glejte poglavje 4.8).
English: As in the narcolepsy studies, no dose response effect was observed.
Slovenian: Kot pri študijah narkolepsije tudi tukaj ni bil ugotovljen učinek odziva na odmerek.
English: The mechanism of action is not entirely understood, but the most consistent findings of the various studies performed are the inhibitory effects on the dopamine and norepinephrine transporters.
Slovenian: Mehanizem delovanja ni v celoti znan, vendar so najbolj dosledne ugotovitve različnih opravljenih študij zaviralni učinki na prenašalca dopamin in norepinefrin.
English: Your doctor will only increase your dose (up to the maximum 400 mg a day) provided that you do not have any liver or kidney problems
Slovenian: Vaš zdravnik bo povečal odmerek (do največ 400 mg na dan) samo v primeru, da nimate težave z jetri ali ledvicami.
English: It should be noted that none of the studies included an objective measurement of sleepiness in the inclusion criteria, which raises additional questions regarding the appropriateness of the population recruited.
Slovenian: Poudariti je treba, da v nobeni študiji niso za vključitveno merilo uporabili objektivne meritve zaspanosti, kar sproža dodatna vprašanja glede primernosti sodelujoče populacije.
English: Existing long term data are not controlled, are based on a subjective parameter and have failed to demonstrate a significant effect of modafinil.
Slovenian: Obstoječi dolgoročni podatki niso bili nadzorovani, temeljijo na subjektivnem parametru in niso uspeli dokazati pomembnega učinka modafinila.
English: The effective elimination half-life of modafinil after multiple doses is about 15 hours.
Slovenian: Učinkovit razpolovni čas izločanja modafinila po več odmerkih je približno 15 ur.
English: • The Committee considered all the available data submitted on the safety and the efficacy of modafinil-containing products.
Slovenian: • Odbor je upošteval vse razpoložljive podatke, predložene v zvezi z varnostjo in učinkovitostjo zdravil, ki vsebujejo modafinil.
English: Once the Commission Decision is issued, the MAHs must submit an updated version of the Risk Management Plan to the National Competent Authorities, taking into account all recommendations made by the CHMP during the procedure and including all the studies described as conditions of the marketing authorisation.
Slovenian: Ko bo izdana odločba Komisije, morajo imetniki dovoljenj za promet z zdravili nacionalnim pristojnim organom predložiti posodobljeno različico načrta za obvladovanje tveganja ob upoštevanju vseh priporočil CHMP med postopkom ter z vključitvijo vseh študij, ki so navedene kot pogoji dovoljenja za promet z zdravilom.
English: In addition, there were reports of suicidal ideation, hostility/aggression and psychotic episodes.
Slovenian: Poleg tega obstajajo poročila o samomorilnih mislih, sovražnosti/napadalnosti in psihotičnih epizodah.
English: Modafinil can be taken by adults who suffer from narcolepsy to help them to stay awake.
Slovenian: Modafinil lahko jemljejo odrasli, ki trpijo za narkolepsijo, da jim pomaga, da ostanejo budni.
English: Having considered the data presented, the CHMP recognises the existence of a consistent short-term effect of modafinil in all variables measured.
Slovenian: Ob upoštevanju predloženih podatkov CHMP priznava obstoj skladnih kratkotrajnih učinkov modafinila pri vseh izmerjenih spremenljivkah.
English: Patients should be monitored for the development of de novo or exacerbation of pre-existing psychiatric disorders (see below and Section 4.8) at every adjustment of dose and then regularly during treatment.
Slovenian: Bolnike je treba nadzorovati za razvoj de novo ali poslabšanje že obstoječih psihiatričnih motenj (glejte spodaj in poglavje 4.8) ob vsaki prilagoditvi odmerka in nato redno med zdravljenjem.
English: The chief metabolite (40 - 50% of the dose), modafinil acid, has no pharmacological activity.
Slovenian: Glavni presnovek (40-50 % odmerka), modafinilijeva kislina, nima nobene farmakološke aktivnosti.
English: The onset or worsening of aggressive or hostile behaviour can be caused by treatment with modafinil.
Slovenian: Pojav ali poslabšanje agresivnega ali sovražnega vedenja je lahko posledica zdravljenja z modafinilom.