FrancophonIA/ELRC3.0 huggingface dataset:
English: It is however noted that the dose-response profile does not seem to be linear.
Slovenian: Vendar so ugotovili, da profil odziva na odmerek ni linearen.
English: The total daily dose may be taken as a single dose in the morning or as two doses in the morning and at noon, according to physician assessment of the patient and the patient's response.
Slovenian: Skupni dnevni odmerek se lahko vzame kot en odmerek zjutraj ali dva odmerka zjutraj ter opoldne, kar je odvisno od zdravnikove ocene bolnika in bolnikovega odziva.
English: SCIENTIFIC CONCLUSIONS Overall summary of the scientific evaluation of modafinil-containing products (see Annex I)
Slovenian: ZNANSTVENI ZAKLJUČKI Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo modafinil (glejte Dodatek I)
English: However, in view of the safety concerns identified during this review, risk minimisation measures are considered necessary to ensure a safe and effective use of the product.
Slovenian: Vendar so z vidika varnostnih zadržkov, odkritih v tem pregledu, obvezni ukrepi za zmanjševanje tveganja, da se zagotovi varna in učinkovita uporaba zdravila.
English: Modafinil is moderately bound to plasma protein (approximately 60%), primarily to albumin, which indicates that there is a low risk of interaction with strongly bound drugs.
Slovenian: Modafinil se zmerno veže na beljakovine v plazmi (približno 60 %), predvsem na albumin, kar kaže, da obstaja majhno tveganje interakcije z močno vezanimi zdravili.
English: If you are pregnant (or think that you may be), are planning to become pregnant, or are breast feeding, you should not take Modafinil containing medicinal products.
Slovenian: Če ste noseči (ali mislite, da ste) ali načrtujete nosečnost ali dojite, ne smete jemati zdravil, ki vsebujejo modafinil.
English: Maintenance of sleep hygiene
Slovenian: Vzdrževanje spalne higiene
English: Modafinil is not recommended for use during pregnancy or in women of childbearing potential unless they are using effective contraception.
Slovenian: Modafinil ni priporočen za uporabo med nosečnostjo ali pri ženskah v rodni dobi, če ne uporabljajo učinkovite kontracepcije.
English: Physicians prescribing modafinil for an extended time should periodically re-evaluate the long-term use for the individual patients as the long-term efficacy of modafinil has not been evaluated (> 9 weeks).
Slovenian: Zdravniki, ki prepisujejo modafinil za daljše obdobje, naj periodično ponovno ocenijo dolgotrajno uporabo za posamezne bolnike, saj dolgoročna (> 9 tednov) učinkovitost modafinila ni bila ocenjena.
English: 1, cours du Triangle 92936 Paris la Défense Cedex
Slovenian: 1, cours du Triangle 92936 Paris la Défense Cedex France
English: Because multi-organ hypersensitivity is variable in its expression, other organ system symptoms and signs, not noted here, may occur.
Slovenian: Ker se multiorganska preobčutljivost izraža različno, se lahko pojavijo simptomi in znaki drugih organskih sistemov, ki tu niso navedeni.
English: The pharmacokinetic properties of modafinil are linear and time-independent.
Slovenian: Farmakokinetične lastnosti modafinila so linearne in neodvisne od časa.
English: Overall, these studies provide proof of the short term efficacy of modafinil in treating excessive daytime sleepiness in patients with narcolepsy.
Slovenian: Na splošno ti študiji dokazujeta kratkoročno učinkovitost modafinila za zdravljenje čezmerne dnevne zaspanosti pri bolnikih z narkolepsijo.
English: The MAHs will provide, within 3 months of the Commission Decision, a feasibility analysis of an epidemiological cardiovascular safety study.
Slovenian: Imetniki dovoljenj za promet z zdravili bodo v 3 mesecih od odločbe Komisije predložili analizo izvedljivosti epidemiološke študije o srčno-žilni varnosti.
English: After 4 weeks of treatment, subjects in study 402 still presented with MSLT values below the normal (i.e. 10 minutes).
Slovenian: Po štirih tednih zdravljenja so imeli preiskovanci v študiji 402 vrednosti MSLT še vedno pod normalno vrednostjo (tj. 10 minut).
English: • Some people have reported having suicidal or aggressive thoughts or behaviour while taking this medicine.
Slovenian: • Nekateri bolniki so med jemanjem tega zdravila poročali o samomorilnih ali agresivnih mislih ali vedenju.
English: Multi-organ hypersensitivity reaction
Slovenian: Multiorganska preobčutljivostna reakcija
English: A later review performed by the MHRA revealed additional concerns regarding the benefit-risk balance of some of the indications for which very limited efficacy data exists.
Slovenian: Pregled, ki ga je kasneje opravila MHRA, je razkril še več zadržkov v zvezi z razmerjem med koristmi in tveganji pri določenih indikacijah, za katere je na voljo zelo malo podatkov o učinkovitosti.
English: Doses of up to 400mg in one or two divided doses can be used in patients with insufficient response to the initial 200mg modafinil dose.
Slovenian: Odmerki do 400 mg v enem ali dveh razdeljenih odmerkih se lahko uporabijo pri bolnikih z nezadostnim odzivom na začetni odmerek 200 mg modafinila.
English: A review of the MAH's pharmacovigilance database identified 873 spontaneous reports of cardiovascular disorders, of which 171 were serious and 17 had a fatal outcome.
Slovenian: Pri pregledu farmakovigilančne zbirke podatkov imetnika dovoljenja za promet z zdravilom je bilo odkritih 873 spontanih poročil o boleznih srca in ožilja, od katerih je bilo 171 resnih, 17 pa s smrtnim izidom.
English: Your doctor will review your treatment regularly to check that it is right for you.
Slovenian: Vaš zdravnik bo redno preučil vaše zdravljenje, da preveri, ali je to primerno za vas.
English: Do not take this medicine after the expiry date which is stated on the blister strip and the outer pack after ‘Exp'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem traku in zunanji ovojnini za besedo »Exp«.
English: Modafinil is not considered to be mutagenic or carcinogenic.
Slovenian: Menijo, da modafinil ni mutagen ali kancerogen.
English: Following consultation with the SAG, the CHMP concluded that the effects on both subjective and objective measures did not provide clear evidence of overall beneficial effect.
Slovenian: CHMP je po posvetovanju s SAG menil, da učinki na subjektivna in objektivna merila ne zagotavljajo jasnega dokaza o splošnem koristnem učinku.
English: Adequate contraception will require continuation of these methods for two months after stopping modafinil.
Slovenian: Ustrezna kontracepcija zahteva nadaljevanje teh metod dva meseca po prenehanju jemanja modafinila.
English: - Moderate to severe chronic shift work sleep disorder (SWSD), approved in 10 Member States.
Slovenian: - zmerno do hudo kronično motnjo spanja zaradi izmenskega dela (SWSD) - odobrena v 10 državah članicah.
English: Modafinil should not be used during breast feeding.
Slovenian: Modafinil se ne sme uporabljati med dojenjem.
English: The data from clinical trials in particular raised concerns about the risk of serious skin disorders requiring hospitalization in association with the use of modafinil in children.
Slovenian: Zlasti podatki iz kliničnih preskušanj so povzročili zadržke zaradi tveganja resnih obolenj kože, ki zahtevajo hospitalizacijo, v povezavi z uporabo modafinila pri otrocih.
English: • The opinion adopted a Product Information which did not fully reflect the safety information for modafinil
Slovenian: • V mnenju so bile sprejete informacije o zdravilu, ki ne odražajo popolnoma varnostnih informacij za modafinil.
English: Although there have been a limited number of reports, multi-organ hypersensitivity reactions may result in hospitalization or be life-threatening.
Slovenian: Čeprav obstaja omejeno število poročil, imajo lahko multiorganske preobčutljivostne reakcije za posledico hospitalizacijo ali pa so življenjsko nevarne.
English: Despite the lack of a clear definition of multi-organ hypersensitivity, reports of allergic reactions involving multiple organs (including a well documented case with a fatal outcome) are of particular concern.
Slovenian: Kljub odsotnosti jasne opredelitve večorganske preobčutljivosti vzbujajo še posebno skrb poročila o alergijskih reakcijah, ki so zajele več organov (vključno z dobro dokumentiranim primerom s smrtnim izidom).
English: Despite the fact that the majority of the spontaneous reports seem to be poorly documented, many included information on de-challenge or re-challenge further supporting a causal role of modafinil in increasing cardiovascular risk.
Slovenian: Kljub dejstvu, da je večina spontanih poročil slabo dokumentiranih, večina vsebuje informacije o odtegnitvi ali ponovnem izzivu, kar dodatno podpira vzročno vlogo modafinila pri povečanju srčno-žilnega tveganja.
English: • Have uncontrolled, moderate to severe high blood pressure (hypertension).
Slovenian: • če imate nenadzorovan zmerno do resno visok krvni tlak (hipertenzijo).
English: The tablets also contain [to be completed nationally] as inactive ingredients.
Slovenian: Tablete poleg tega vsebujejo [izpolni država članica] kot pomožne snovi.
English: Adults with severe kidney and liver problems The usual dose is 100 mg a day.
Slovenian: Odrasli s hudimi težavami z ledvicami ali jetri Običajni odmerek je 100 mg na dan.
English: The Summary of Product Characteristics should also clearly mention that modafinil is not recommended for use in children and during pregnancy and lactation.
Slovenian: V povzetku glavnih značilnosti zdravila mora biti tudi jasno navedeno, da modafinil ni priporočljiv za uporabo pri otrocih ter med nosečnostjo in v obdobju dojenja.
English: There was no effect on fertility and no evidence of teratogenic potential at systemic exposures equivalent to the maximum recommended human dose.
Slovenian: Ni bilo učinka na plodnost in dokazov za teratogeni potencial pri sistemski izpostavitvi, enakovredni največjemu priporočenemu odmerku za ljudi.
English: Modafinil does not appear to be a direct 1-adrenoceptor agonist.
Slovenian: Ne zdi se, da bi bil modafinil neposredni agonist 1-adrenoreceptorja.
English: Maintenance of the efficacy in the long term has not been demonstrated, as the existing long term data is uncontrolled.
Slovenian: Ohranitev dolgoročne učinkovitosti ni bila dokazana, saj obstoječi dolgoročni podatki niso bili nadzorovani.
English: Systemic exposure increases in a dose proportional manner over the range of 200-600 mg.
Slovenian: Sistemska izpostavljenost se poveča skladno z odmerkom, od 200-600 mg.
English: Having considered the data presented, it is the Committee's view that modafinil is associated to a rare risk of serious, life-threatening skin reactions.
Slovenian: Ob upoštevanju predloženih podatkov je Odbor mnenja, da je modafinil povezan z redkim tveganjem resnih, smrtno nevarnih kožnih reakcij.
English: Patients with excessive sleepiness, including those taking modafinil should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity.
Slovenian: Bolniki s pretirano zaspanostjo, vključno s tistimi, ki jemljejo modafinil, naj se pogosto ponovno ocenijo glede stopnje zaspanosti in po potrebi naj se jim svetuje, naj se izogibajo vožnji ali drugim potencialno nevarnim dejavnostim.
English: • Are allergic (hypersensitive) to modafinil, or to any of the other ingredients of these tablets (see section 6 ‘What Modafinil containing medicinal products contains').
Slovenian: • če ste alergični (preobčutljivi) na modafinil ali na katerokoli sestavino teh tablet (glejte poglavje 6 »Kaj vsebujejo zdravila, ki vsebujejo modafinil«);
English: The MAHs should inform healthcare professionals on the outcome of this review on modafinil via a Direct Healthcare Professional Communication (DHPC) to be distributed the Monday after 5 days have passed from the adoption of the European Commission Decision.
Slovenian: Imetniki dovoljenj za promet z zdravili morajo obvestiti zdravstvene delavce o izidu tega pregleda modafinila z neposrednim obvestilom zdravstvenim delavcem (DHPC), ki se pošlje v ponedeljek po preteku petih dni po sprejemu odločbe Evropske komisije.
English: If you take more Modafinil containing medicinal products than you should If you take too many tablets you may feel sick, restless, disorientated, confused or excited.
Slovenian: Če ste vzeli večji odmerek zdravil, ki vsebujejo modafinil, kot bi smeli Če ste vzeli preveč tablet, se lahko počutite slabo, nemirno, dezorientirano, zmedeno ali razburjeno.
English: Because safety and effectiveness in controlled studies in children have not been established and because of the risk of serious cutaneous hypersensitivity and psychiatric adverse reactions, the use of modafinil is not recommended
Slovenian: Ker varnost in učinkovitost v kontroliranih študijah pri otrocih nista bili ugotovljeni in zaradi tveganja resne kožne preobčutljivosti in psihiatričnih neželenih učinkov, uporaba modafinila ni priporočena.
English: The large number of spontaneous reports seems to support this association.
Slovenian: Zdi se, da to povezavo podpira veliko število spontanih poročil.
English: This difference in clearance is partially offset by the younger patients' smaller size and lower weight which results in comparable exposure following administration of comparable doses.
Slovenian: Ta razlika pri očistku je delno posledica manjše velikosti in manjše telesne mase mlajših bolnikov, ki povzročita primerljivo izpostavljenost po uporabi primerljivih odmerkov.
English: Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: The efficacy in the long term has also not been demonstrated, as the existing long term data is uncontrolled and only subjective parameters were measured.
Slovenian: Dolgoročna učinkovitost ravno tako ni bila dokazana, saj obstoječi dolgoročni podatki niso bili nadzorovani in so bili izmerjeni samo subjektivni parametri.
English: Excessive sleepiness is defined as difficulty maintaining wakefulness and an increased likelihood of falling asleep in inappropriate situations.
Slovenian: Čezmerna zaspanost je opredeljena kot težko vzdrževanje budnosti in povečana verjetnost, da bo bolnik zaspal v neprimernih situacijah.
English: • You have sudden difficulty breathing or wheeziness or your face, mouth or throat begins to swell.
Slovenian: • imate nenadne težave z dihanjem ali zasoplost ali pa vaš obraz, usta ali grlo začnejo zatekati;
English: Contact your nearest hospital casualty department or tell your doctor or pharmacist immediately.
Slovenian: Takoj se obrnite na najbližji urgentni oddelek bolnišnice ali obvestite zdravnika ali farmacevta.
English: However, after assessing a subgroup analysis of OSA patients based on possible prognostic factors, the CHMP concluded that it did not allow identification of any specific subgroup where modafinil would have the greatest chance of benefit.
Slovenian: Vendar je CHMP po oceni analize podskupin bolnikov z OSA na osnovi možnih prognostičnih dejavnikov menil, da analiza ni omogočila odkritja specifičnih podskupin, v katerih bi bilo najbolj verjetno, da bo imel modafinil koristi.
English: Modafinil promotes wakefulness in a variety of species, including man.
Slovenian: Modafinil spodbuja budnost pri različnih vrstah, vključno s človekom.
English: Severe chronic renal failure (creatinine clearance up to 20 mL/min) did not significantly affect the pharmacokinetics of modafinil administered at 200 mg, but exposure to modafinil acid was increased 9-fold.
Slovenian: Huda kronična ledvična odpoved (očistek kreatinina do 20 ml/min) ni pomembno vplivala na farmakokinetiko modafinila v odmerku 200 mg, vendar pa se je izpostavljenost modafinilijevi kislini povečala za devetkrat.
English: There are no factors that are known to predict the risk of occurrence or the severity of multi-organ hypersensitivity reactions associated with modafinil.
Slovenian: Ni dejavnikov, s katerimi bi lahko predvideli tveganje pojava ali resnost multiorganskih preobčutljivostnih reakcij, povezanih z modafinilom.
English: The CHMP Scientific Advisory Group (SAG) was also consulted.
Slovenian: CHMP se je posvetoval tudi z znanstveno svetovalno skupino (SAG) pri CHMP.
English: The wake-promoting effects of modafinil are antagonised by D1/D2 receptor antagonists suggesting that it has indirect agonist activity.
Slovenian: Učinki spodbujanja budnosti modafinila zavirajo antagonisti receptorjev D1/D2, kar kaže na njegovo posredno agonistično dejavnost.
English: You may also have difficulty sleeping, diarrhoea, hallucinations (sensing things that are not real), chest pain, a change in the speed of your heart beat or an increase in blood pressure.
Slovenian: Prav tako boste morda imeli težave s spanjem, diarejo, halucinacijami (zaznavanjem stvari, ki niso resnične), bolečinami v prsnem košu, spremembo hitrosti bitja srca ali povečan krvni tlak.
English: In light of this, and because of its known safety profile, the demonstrated benefit is outweighed by the risks.
Slovenian: Zaradi tega in zaradi znanega varnostnega profila je prikazana prednost premajhna, da bi odtehtala tveganja.
English: Reproduction toxicity studies revealed no effect on fertility, nor any teratogenic effect, nor any effect on viability, growth or development of the offspring.
Slovenian: Študije reproduktivne toksičnosti niso pokazale učinka na plodnost, teratogenega učinka in učinkov na viabilnost, rast ali razvoj potomcev.
English: The recommended starting daily dose is 200 mg.
Slovenian: Priporočeni začetni dnevni odmerek je 200 mg.
English: While the data presented by the MAH on abuse, misuse and diversion does not allow a conclusion on the abuse/misuse potential of the product, these results may have been influenced by the fact that relevant populations (such as students) have not have been included.
Slovenian: Čeprav podatki o zlorabi, napačni uporabi in rekreativni uporabi, ki jih je predstavil imetnik dovoljenja za promet z zdravilom, ne omogočajo sklepov o potencialu zdravila za zlorabo/napačno uporabo, je na rezultate morda vplivalo dejstvo, da pomembne populacije (kot so študenti) niso bile zajete.
English: While modafinil is not currently approved for paediatric use, a number of serious adverse reactions have been reported in children.
Slovenian: Čeprav modafinil trenutno ni odobren za pediatrično uporabo, so poročali o številnih neželenih učinkih pri otrocih.
English: If you are affected or you find that while using this medication you still feel very sleepy, do not attempt to drive or operate machinery.
Slovenian: Če ste prizadeti ali ugotovite, da ste vseeno zelo zaspani, ko uporabljate to zdravilo, ne poskušajte voziti ali upravljati strojev.
English: Prothrombin times should be monitored regularly during the first 2 months of modafinil use and after changes in modafinil dosage.
Slovenian: Protrombinski časi naj se redno nadzorujejo med prvima dvema mesecema uporabe modafinila in po spremembah njegovega odmerka.
English: Modafinil containing medicinal products and certain other medicines can affect each other and your doctor may need to adjust the doses that you are taking.
Slovenian: Zdravila, ki vsebujejo modafinil, in nekatera druga zdravila lahko vplivajo drugo na drugo, zato bo morda zdravnik moral prilagoditi odmerke, ki jih jemljete.
English: The active ingredient in the tablets is modafinil.
Slovenian: Zdravilna učinkovina v tabletah je modafinil.
English: In clinical trials of modafinil, the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in paediatric patients (age <17 years); this includes serious rash.
Slovenian: V kliničnih študijah z modafinilom je bila pogostnost izpuščaja, ki je imela za posledico prekinitev zdravljenja, približno 0,8 % (13 od 1585) pri pediatričnih bolnikih (starost < 17 let); to vključuje tudi pojav hudega izpuščaja.
English: Antidepressants: A number of tricyclic antidepressants and selective serotonin reuptake inhibitors are largely metabolised by CYP2D6.
Slovenian: Antidepresivi: Več tricikličnih antidepresivov in selektivnih zaviralcev ponovnega privzema serotonina se večinoma presnavlja s CYP2D6.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH
English: Fertility No data on fertility are available.
Slovenian: Plodnost Podatki o plodnosti niso na voljo.
English: Modafinil should be used only in patients who have had a complete evaluation of their excessive sleepiness, and in whom a diagnosis of narcolepsy, has been made in accordance with ICSD diagnostic criteria.
Slovenian: Modafinil naj se uporablja samo pri bolnikih, pri katerih je bila izvedena celotna ocena pretirane zaspanosti in postavljena diagnoza narkolepsije skladno z diagnostičnimi merili ICSD.
English: The outcomes of this study should be: first occurrence of myocardial infarction, cardiovascular death, cardiovascular hospitalisation and all cause mortality.
Slovenian: Izidi te študije morajo biti: prvi pojav miokardnega infarkta, smrt zaradi srčno-žilnega dogodka, hospitalizacija zaradi srčno-žilnega dogodka in smrtnost zaradi vseh vzrokov.
English: - Obstructive Sleep Apnoea (OSA), approved in 11 Member States;
Slovenian: - obstruktivno apnejo med spanjem (OSA) - odobrena v 11 državah članicah;
English: Your doctor will need to check these regularly while you are taking Modafinil containing medicinal products.
Slovenian: Vaš zdravnik bo to redno preverjal, ko boste jemali zdravila, ki vsebujejo modafinil;
English: Because this type of event is considered to be rare, to have observed cases in a clinical trial setting is unexpected and considered indicative of an incidence higher than previously thought.
Slovenian: Ker se tovrstni dogodki štejejo za redke, je pojav primerov v kliničnem preskušanju nepričakovan in kaže, da je pojavnost večja, kakor je bilo domnevano do zdaj.
English: Results from clinical interaction studies suggest that the largest effects may be on substrates of CYP3A4/5 that undergo significant presystemic elimination, particularly via CYP3A enzymes in the gastrointestinal tract.
Slovenian: Rezultati kliničnih študij medsebojnega delovanja kažejo, da bi bili učinki največji na substrate CYP3A4/5, ki so podvrženi pomembnemu predsistemskemu izločanju, zlasti prek encimov CYP3A v gastrointestinalnem traktu.
English: This may seem a small absolute increase but in view of the cardiovascular risk associated to this population, and the fact that it is an asymptomatic consequence of treatment, it cannot be dismissed.
Slovenian: To se zdi kot majhno absolutno povečanje, vendar nezanemarljivo z vidika srčno-žilnega tveganja, povezanega s to populacijo, in dejstva, da gre za asimptomatsko posledico zdravljenja.
English: Even though the prevalence of idiopathic hypersomnia is thought to be very low (between 1/10 000 and 1/25 000 for IH with long sleep time and between 1/11 000 and 1/100 000 for IH without long sleep time) and the difficulties in conducting large scale trials are acknowledged, no conclusions can be drawn to support the efficacy of the product with such a limited dataset.
Slovenian: Čeprav naj bi bila pogostnost idiopatske hipersomnije zelo majhna (med 1/10 000 in 1/25 000 za IH z dolgim spanjem ter med 1/11 000 in 1/100 000 za IH brez dolgega spanja) in ob upoštevanju težavnosti izvedbe velikih preskušanj, ni možno sprejeti sklepov v podporo učinkovitosti zdravila na osnovi tako majhne zbirke podatkov.
English: The excretion of modafinil and its metabolites is chiefly renal, with a small proportion being eliminated unchanged (< 10% of the dose).
Slovenian: Izločanje modafinila in njegovih presnovkov večinoma poteka v ledvicah, majhen delež pa se izloči nespremenjen (< 10 % odmerka).