FrancophonIA/ELRC3.0 huggingface dataset:
English: While some of the pre-clinical studies have shown reproductive toxicity, the available human data are insufficient to establish whether toxicity occurs in humans during pregnancy and lactation.
Slovenian: Čeprav so v nekaterih predkliničnih študijah dokazali toksičen vpliv na sposobnost razmnoževanja, so razpoložljivi podatki za človeka nezadostni za ugotovitve, ali se pri človeku toksičnost pojavlja med nosečnostjo in dojenjem.
English: Pharmacotherapeutic group: Psychoanaleptic, centrally acting sympathomimetic, ATC code: N06BA
Slovenian: Farmakoterapevtska skupina: Psihoanaleptični simpatomimetiki z osrednjim delovanjem, oznaka ATC: N06BA
English: Such an evaluation usually consists, in addition to the patient's history, sleep measurements testing in a laboratory setting and exclusion of other possible causes of the observed hypersomnia.
Slovenian: Taka ocena je navadno sestavljena iz - poleg anamneze bolnika - testiranja z meritvami spanja v laboratorijskem okolju in z izključitvijo drugih možnih vzrokov opažene hipersomnije.
English: Narcolepsy is a condition that causes excessive daytime sleepiness and a tendency to fall asleep suddenly in inappropriate situations (sleep attacks).
Slovenian: Narkolepsija je stanje, ki povzroči pretirano zaspanost podnevi in nagnjenost k temu, da človek zaspi nenadoma in v neprimernih situacijah (napadi spanja).
English: Modafinil may increase its own metabolism via induction of CYP3A4/5 activity but the effect is modest and unlikely to have significant clinical consequences.
Slovenian: Modafinil lahko poveča lastni metabolizem z indukcijo CYP3A4/5, vendar pa so učinki zmerni in ni verjetno, da bodo imeli pomembne klinične posledice.
English: The other indications for modafinil are excessive sleepiness associated with:
Slovenian: Druge indikacije za uporabo modafinila so čezmerna zaspanost, povezana z:
English: The efficacy of modafinil in patients with obstructive sleep apnoea (OSA) exhibiting excessive day time sleepiness despite treatment with continuous positive airways pressure (CPAP) has been studied in short term randomised controlled clinical trials.
Slovenian: Učinkovitost modafinila pri bolnikih z obstrukcijsko spalno apnejo (OSA), ki kažejo pretirano zaspanost čez dan kljub zdravljenju s stalnim pozitivnim tlakom v dihalnih poteh (CPAP), je bila preučevana v kratkoročnih randomiziranih nadzorovanih kliničnih študijah.
English: Administration of modafinil results in electrophysiological changes indicative of increased alertness and improvements in objective measures of ability to sustain wakefulness.
Slovenian: Uporaba modafinila povzroči elektrofiziološke spremembe, ki kažejo na povečano budnost in izboljšanje objektivnih meril za sposobnost vzdrževanja budnosti.
English: The majority of the spontaneous reports reviewed indicated that onset of events was within the first few months of initiating modafinil, and positive de-challenge or re-challenge was also reported.
Slovenian: V večini pregledanih spontanih poročil je bilo navedeno, da so dogodki nastopili v prvih nekaj mesecih po uvedbi modafinila, omenjeni pa so bili tudi pozitivni rezultati odtegnitve ali ponovnega izziva.
English: The MAHs will continue to perform surveillance of severe skin reactions in the German Severe Cutaneous Adverse Reactions (SCAR) registry.
Slovenian: Imetniki dovoljenj za promet z zdravili bodo še naprej spremljali hude kožne reakcije v nemškem registru resnih kožnih neželenih učinkov (SCAR).
English: The MAHs will conduct a retrospective drug utilisation study of the use of modafinil in the primary care setting, with data retrieved and analysed at least from the UK General Practice Research Database (GPRD).
Slovenian: Imetniki dovoljenj za promet z zdravili bodo opravili retrospektivno študijo uporabe modafinila v okolju primarne oskrbe s podatki, ki jih bodo pridobili in analizirali vsaj iz zbirke podatkov iz raziskav splošne medicine (General Practice Research Database, GPRD) iz Združenega kraljestva.
English: A search of the MAH's pharmacovigilance database revealed a total of 485 reports related to abuse, misuse, dependency and tolerance associated to modafinil use.
Slovenian: Pri iskanju po farmakovigilančni zbirki podatkov imetnika dovoljenja za promet z zdravilom so odkrili 485 poročil v zvezi z zlorabo, napačno uporabo, odvisnostjo ali toleranco v zvezi z uporabo modafinila.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of Modafinil/metabolites in milk (for details see 5.3).
Slovenian: Razpoložljivi farmakodinamski/toksikološki podatki pri živalih so pokazali izločanje modafinila/presnovkov v mleku (za podrobnosti glejte poglavje 5.3).
English: Although statistically significant improvements in sleepiness were noted, the magnitude of effect and response rate to modafinil was small when assessed by objective measurements and limited to a small sub-population of the treated patients.
Slovenian: Čeprav so bile opažene pomembne izboljšave pri zaspanosti, je bila velikost učinka in stopnja odziva na modafinil majhna, ko je bila ocenjena z objektivnim merjenjem, in omejena na majhno podpopulacijo zdravljenih bolnikov.
English: The frequency of adverse reactions considered at least possibly related to treatment, in clinical trials involving 1561 patients taking modafinil were as follows: very common (≥1/10), common (≥1/100 to ≤1/10), uncommon (≥1/1000 to ≤1/100), unknown (cannot be estimated from the available data).
Slovenian: Pogostnost neželenih učinkov v kliničnih preskušanjih s 1561 bolniki, ki so jemali modafinil, in ki se štejejo za vsaj verjetno povezane z zdravljenjem, je bila naslednja: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do ≤ 1/10), občasni (≥ 1/1000 do ≤ 1/100), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: If you forget to take Modafinil containing medicinal products If you forget to take your medicine take the next dose at the usual time, do not take a double dose to make up for the forgotten one.
Slovenian: Če pozabite vzeti zdravilo, ki vsebuje modafinil Če pozabite vzeti zdravilo, vzemite naslednji odmerek ob običajnem času.
English: Very common side effects (affecting more than 1 in 10 people): • Headache
Slovenian: Zelo pogosti neželeni učinki (pojavijo se pri več kot 1 od 10 bolnikov): - glavobol.
English: The percentage of patients experiencing a psychiatric adverse event in clinical trials is also significant, particularly when compared to placebo.
Slovenian: Odstotek bolnikov s psihiatričnimi neželenimi učinki je bil pomemben tudi v kliničnih preskušanjih, zlasti v primerjavi s placebom.
English: • The opinion did not accurately reflect the data supporting the efficacy of Modafinil in the indication excessive sleepiness associated with obstructive sleep apnoea.
Slovenian: • Mnenje ni natančno odražalo podatkov, ki podpirajo učinkovitost modafinila za indikacijo čezmerne zaspanosti v povezavi z obstruktivno apnejo med spanjem.
English: Modafinil is well-absorbed with peak plasma concentration reached approximately two to four hours after administration.
Slovenian: Modafinil se dobro absorbira in doseže največjo koncentracijo v plazmi po približno dveh do štirih urah po uporabi.
English: In addition, there was no significant difference between placebo and modafinil in the percentage of patients who normalise their MSLT scores, which is indicative that a clinically relevant effect has not been established.
Slovenian: Poleg tega ni bilo bistvene razlike med placebom in modafinilom v odstotku bolnikov, pri katerih je prišlo do normalnih vrednosti MSLT, kar kaže, da klinično pomemben učinek ni bil dosežen.
English: An ECG is recommended in all patients before Modafinil treatment is initiated.
Slovenian: Pri vseh bolnikih se priporoča EKG pred začetkom zdravljenja z modafinilom.
English: A monitoring programme to assess the abuse and misuse potential of modafinil was conducted between 1999 and 2007, and consisted of online monitoring of modafinil references and messages.
Slovenian: V obdobju od leta 1999 do leta 2007 je bil opravljen program spremljanja za oceno potenciala zlorabe in napačne uporabe modafinila, ki je obsegal spletno spremljanje omemb modafinila in sporočil o njem.
English: Treatment should be initiated by or under the supervision of a physician with appropriate knowledge of indicated disorders (see section 4.1).
Slovenian: Zdravljenje mora začeti zdravnik z ustreznim znanjem o indiciranih motnjah ali mora biti pod njegovim nadzorom (glejte poglavje 4.1).
English: Toxicology studies by single and repeated dosing have revealed no particular toxic action in animals.
Slovenian: Toksikološke študije enkratnega odmerka in ponavljajočih se odmerkov pri živalih niso pokazale določenega toksičnega delovanja.
English: In addition modafinil does not address the underlying cause of the obstruction and, in a clinical setting where treatments are expected to be long lasting, the lack of controlled long-term efficacy data is a cause for concern.
Slovenian: Poleg tega modafinil ne vpliva na osnovni vzrok obstrukcije, v kliničnem okolju, kjer se od zdravljenj pričakuje dolgoročni učinek, pa je odsotnost podatkov o dolgoročni učinkovitosti razlog za zadržek.
English: Further information should also be collected on use in pregnancy and lactation, potential for abuse/misuse and diversion and off-label use.
Slovenian: Dodatne podatke je treba zbrati o uporabi med nosečnostjo in v obdobju dojenja, potenciala za zlorabo/napačno uporabo in rekreativno uporabo ter uporabo zunaj obsega indikacij.
English: In addition, a contraindication in patients with uncontrolled hypertension or cardiac arrhythmia is deemed necessary to prevent serious complications in patients with such co-morbidities.
Slovenian: Poleg tega je potrebna kontraindikacija pri bolnikih z nenadzorovano hipertenzijo ali srčno aritmijo, da se preprečijo resni zapleti pri bolnikih s takšnimi sočasnimi boleznimi.
English: Talk to your doctor about the birth control methods that will be right for you while you are taking Modafinil containing medicinal products (and for two months after stopping) or if you have any other concerns.
Slovenian: Pogovorite se z zdravnikom o metodah kontracepcije, ki so primerne za vas, medtem ko jemljete zdravila, ki vsebujejo modafinil (in dva meseca po prenehanju) ali če imate druge pomisleke.
English: However, modafinil binds to the norepinephrine transporter and inhibits norepinephrine uptake, but these interactions are weaker than those observed with the dopamine transporter.
Slovenian: Modafinil pa se veže na prenašalca noradrenalina in zavira privzem noradrenalina, vendar so te interakcije šibkejše kot interakcije, ki so jih opazili pri prenašalcu dopamina.
English: As a result, the product information for modafinil was updated across Europe to include strengthened warnings.
Slovenian: Posledično so v Evropi posodobili informacije o zdravilih, ki vsebujejo modafinil, tako da so vključili okrepljena opozorila.
English: In addition, in vitro induction of CYP1A2, CYP2B6 and CYP3A4/5 activities has been observed in human hepatocytes, which were it to occur in vivo, could decrease the blood levels of drugs metabolised by these enzymes, thereby possibly decreasing their therapeutic effectiveness.
Slovenian: Poleg tega je bila opažena in vitro indukcija CYP1A2, CYP2B6 in CYP3A4/5 v človeških hepatocitih, ki bi, če bi se zgodila in vivo, lahko zmanjšala krvne ravni zdravil, ki jih presnavljajo ti encimi, s čimer bi mogoče zmanjšala njihovo terapevtsko učinkovitost.
English: The 400 mg dose in study 303 did not lead to higher MWT differences or improved ESS score than the 200 mg dose.
Slovenian: Odmerek 400 mg v študiji 303 ni povzročil večjih razlik v rezultatih testa MWT ali izboljšanja vrednosti ESS v primerjavi z odmerkom 200 mg.
English: This includes 69 events of torsades de pointes/QT prolongation, 405 of cardiac arrhythmia, 74 of cardiac failure, 205 of hypertension, 462 of cardiomyopathy and 57 of ischemic heart disease.
Slovenian: To vključuje 69 primerov torsades de pointes/podaljšanja QT, 405 primerov srčne aritmije, 74 primerov srčnega popuščanja, 205 primerov hipertenzije, 462 primerov kardiomiopatije in 57 primerov ishemične bolezni srca.
English: In clinical trials, another 3 cases of Serious Cutaneous Adverse Reactions (SCARs) have been observed, which is of particular concern given the rare background incidence rate of such events.
Slovenian: V kliničnih preskušanjih so opazili še 3 primere hudih neželenih učinkov na kožo (SCAR), ki resno vzbujajo skrb glede na redko izhodiščno stopnjo pojavnosti takšnih dogodkov.
English: In study 402, MSLT increased from 7.6 minutes at baseline to 8.6 minutes.
Slovenian: V študiji 402 so se rezultati multiplega testa latence uspavanja (MSLT) povečali s 7,6 minute v izhodišču na 8,6 minute.
English: Following the CHMP conclusion and recommendations for modafinil-containing medicinal products, one MAH submitted detailed grounds for the re-examination of the CHMP opinion.
Slovenian: Ko je CHMP sprejel zaključek in priporočila za zdravila, ki vsebujejo modafinil, je en imetnik dovoljenja za promet z zdravilom predložil podrobno utemeljitev zahtevka za ponovni pregled mnenja CHMP.
English: The MAHs will conduct a pharmacoepidemiological study using large-linked claims databases in the United States to further assess the incidence of Stevens-Johnson syndrome and toxic epidermal necrolysis.
Slovenian: Imetniki dovoljenj za promet z zdravili bodo opravili farmakoepidemiološko študijo z uporabo velikih povezanih zbirk podatkov zahtevkov v ZDA za dodatno oceno pojavnosti Stevens-Johnsonovega sindroma in toksične epidermalne nekrolize.
English: The fact that all 3 serious SCARs observed in the modafinil clinical trials have occurred in children is indicative of a higher incidence of these reactions in the paediatric population.
Slovenian: Dejstvo, da so se vsi 3 resni učinki SCAR, opaženi v kliničnih preskušanjih modafinila, pojavili pri otrocih, kaže na visoko pojavnost teh učinkov v pediatrični populaciji.
English: While a significant improvement was seen in CGI-C and PVT scores for modafinil treated subjects, these are subjective measures and their validity for use in this specific type of sleep disorder is unclear.
Slovenian: Čeprav so pri preiskovancih, ki so prejemali modafinil, odkrili bistveno izboljšanje vrednosti CGI-C in PVT, gre za subjektivna merila in njihova veljavnost za uporabo pri tej specifični vrsti motnje spanja ni jasna.
English: In narcoplesy, however, the benefits of modafinil have been clearly and significantly demonstrated in double blind controlled clinical trials, both in objective and subjective measurements.
Slovenian: Vendar so bile koristi modafinila pri narkolepsiji jasno in pomembno dokazane v dvojno zaslepljenih, nadzorovanih preskušanjih z objektivnimi in subjektivnimi meritvami.
English: Sexually active women of child-bearing potential should be established on a contraceptive programme before taking modafinil.
Slovenian: Spolno aktivne ženske v rodni dobi naj začnejo program kontracepcije, preden začnejo jemati modafinil.
English: Examples include ciclosporin, HIV-protease inhibitors, buspirone, triazolam, midazolam and most of the calcium channel blockers and statins.
Slovenian: Med njimi so ciklosoporin, inhibitorji proteaze HIV, buspiron, triazolam, midazolam ter večina zaviralcev kalcijevih kanalčkov in statinov.
English: In patients deficient in CYP2D6 (approximately 10% of a Caucasian population) a normally ancillary metabolic pathway involving CYP2C19 becomes more important.
Slovenian: Pri bolnikih, ki imajo deficienco CYP2D6 (približno 10 % belske populacije), postanejo pomembnejše presnovne poti s CYP2C19, ki so običajno pomožne.
English: In a case report, a 50% reduction in ciclosporin concentration was observed in a patient receiving ciclosporin in whom concurrent treatment with modafinil was initiated.
Slovenian: V poročilu o primeru je bilo opaženo 50-odstotno zmanjšanje koncentracij ciklosporina pri bolniku, ki je prejemal ciklosporin in pri katerem je bilo uvedeno sočasno zdravljenje z modafinilom.
English: Patient monitoring and clinical assessment of the need for treatment should be performed on a periodic basis.
Slovenian: Bolnike je treba periodično spremljati in klinično ocenjevati glede potrebe po zdravljenju.
English: Multi-organ hypersensitivity reactions, including at least one fatality in post-marketing experience, have occurred in close temporal association to the initiation of modafinil.
Slovenian: Multiorganska preobčutljivostna reakcija, vključno z vsaj enim smrtnim primerom po začetku trženja zdravila, je bila opažena v tesni časovni povezavi z začetkom zdravljenja z modafinilom.
English: Other things to talk to your doctor or pharmacist about
Slovenian: Druge stvari, o katerih se morate pogovoriti z zdravnikom ali s farmacevtom
English: Severe rashes may cause blistering or peeling of the skin, ulcers in your mouth, eyes, nose or genitals.
Slovenian: Resni izpuščaji lahko povzročijo tudi mehurje ali lupljenje kože, razjede v ustih, očeh, na nosu ali genitalijah.
English: Almost half of all the adverse events reported for modafinil appear to be reported in use outside of the approved indications.
Slovenian: Videti je, da so pri skoraj polovici vseh poročil o neželenih učinkih modafinila poročali v zvezi z uporabo zunaj odobrenih indikacij.
English: Modafinil is associated with the onset or worsening of anxiety.
Slovenian: Modafinil je povezan z nastopom ali poslabšanjem anksioznosti.
English: In humans, modafinil restores and/or improves the level and duration of wakefulness and daytime alertness in a dose-related manner.
Slovenian: Pri ljudeh modafinil na način, povezan z odmerkom, ponovno vzpostavi in/ali izboljša stopnjo in trajanje budnosti in dnevne živahnosti.
English: Patients with abnormal levels of sleepiness who take modafinil should be advised that their level of wakefulness may not return to normal.
Slovenian: Bolniki z nenormalnimi ravnmi zaspanosti, ki jemljejo modafinil, naj upoštevajo, da se njihova raven budnosti morda ne bo vrnila na normalno.
English: As modafinil may reduce the effectiveness of oral contraception alternative additional methods of contraception are required (see section 4.5).
Slovenian: Ker lahko modafinil zmanjša učinkovitost peroralne kontracepcije, so zahtevane dodatne alternativne kontracepcijske metode (glejte razdelek 4.5.)
English: What Modafinil containing medicinal products is and what it is used for Before you take Modafinil containing medicinal products How to take Modafinil containing medicinal products Possible side effects
Slovenian: Kaj so zdravila, ki vsebujejo modafinil, in za kaj jih uporabljamo Kaj morate vedeti, preden boste vzeli zdravila, ki vsebujejo modafinil Kako jemati zdravila, ki vsebujejo modafinil Možni neželeni učinki
English: Once steady-state is reached, the pharmacokinetic properties of modafinil do not appear to change with continued administration for up to 1 year.
Slovenian: Ko se doseže stanje dinamičnega ravnovesja, se farmakokinetične lastnosti modafinila ob neprekinjeni uporabi ne spreminjajo do enega leta.
English: Modafinil- containing medicinal products is indicated in adults for the treatment of excessive sleepiness associated with narcolepsy with or without cataplexy.
Slovenian: Zdravila, ki vsebujejo modafinil, so pri odraslih indicirana za zdravljenje čezmerne zaspanosti, povezane z narkolepsijo s katapleksijo ali brez nje.
English: This syndrome may present with ischaemic ECG changes, chest pain or arrhythmia.
Slovenian: Ta sindrom se lahko pojavi z ishemičnimi spremembami EKG, bolečinami v prsih ali aritmijo.
English: In fact, no statistically significant difference was noted between the two modafinil doses used (200 and 400 mg) in any of the measurements.
Slovenian: Dejansko pri nobeni od meritev ni bilo statistično pomembne razlike med dvema uporabljenima odmerkoma modafinila (200 mg in 400 mg).
English: This circumstance is the result of metabolic auto-induction noted in the pre-clinical studies.
Slovenian: To je posledica samodejne presnovne indukcije, ki so jo opazili v predkliničnih študijah.
English: One MAH has implemented a pregnancy registry in the United States to systematically collect data on the effect of modafinil exposure in women of childbearing potential during pregnancy, labour and delivery.
Slovenian: En imetnik dovoljenja za promet z zdravilom je uvedel register nosečnosti v ZDA za sistematično zbiranje podatkov o učinkih izpostavitve modafinilu pri ženskah v rodni dobi med nosečnostjo, popadki in porodom.
English: There are 517 cases of hostility/aggression (4 of which with a fatal outcome), 331 cases of psychosis/psychotic disorders (of which 1 had a fatal outcome), 330 cases of depression and 118 cases of suicide/self-injury (15 with a fatal outcome).
Slovenian: 331 primerov psihoz/psihotičnih motenj (od tega 1 s smrtnim izidom), 330 primerov depresije in 118 primerov samomora/samopoškodovanja (od tega 15 s smrtnim izidom).
English: Uncontrolled moderate to severe hypertension and in patients with cardiac arrhythmias.
Slovenian: Nenadzorovana zmerna do huda hipertenzija in bolniki s srčnimi aritmijami.
English: Patients with major anxiety should only receive treatment with modafinil in a specialist unit.
Slovenian: Bolniki s hudo anksioznostjo se smejo z modafinilom zdraviti le v za to specializirani enoti.
English: As modafinil may inhibit CYP2C19, lower doses of antidepressants may be required in such patients.
Slovenian: Ker lahko modafinil zavira CYP2C19, so lahko pri teh bolnikih potrebni manjši odmerki antidepresivov.
English: Since the effectiveness of steroidal contraceptives may be reduced when used with modafinil, alternative or concomitant methods of contraception are recommended, and for two months after discontinuation of modafinil (also see 4.5 with respect to potential interaction with steroidal contraceptives).
Slovenian: Ker je lahko učinkovitost hormonske kontracepcije zmanjšana, kadar se uporablja skupaj z modafinilom, je priporočena uporaba alternativnih ali sočasnih metod kontracepcije in še dva meseca po prekinitvi jemanja modafinila (glejte tudi poglavje 4.5 za potencialne interakcije s hormonsko kontracepcijo).
English: Like all medicines, Modafinil containing medicinal products can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila imajo lahko tudi zdravila, ki vsebujejo modafinil, neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Modafinil is associated with the onset or worsening of psychotic symptoms or manic symptoms (including hallucinations, delusions, agitation or mania).
Slovenian: Modafinil je povezan z nastopom ali poslabšanjem psihotičnih simptomov ali maničnih simptomov (vključno s halucinacijami, blodnjami, agitacijo ali manijo).
English: It is noted during the discussion with the MAH that, in the clinical trials, there was an average blood pressure increase of 2-3 mmHg of systolic blood pressure during the long term extension of pivotal studies.
Slovenian: Med razpravo z imetnikom dovoljenja za promet z zdravilom je bilo ugotovljeno, da se je v kliničnih preskušanjih med dolgoročnim podaljšanjem ključnih študij sistolični krvni tlak v povprečju povečal za 2-3 mmHg.
English: No serious skin rashes have been reported in adult clinical trials (0 per 4,264) of modafinil.
Slovenian: Pri kliničnih študijah pri odraslih niso poročali o hudih kožnih izpuščajih (0 od 4264).
English: ORCHID EUROPE LTD Building 3, Chiswick park
Slovenian: ORCHID EUROPE LTD Building 3, Chiswick park 556, Chiswick High Road London
English: In addition, following repeat-dose administration of modafinil to children and adolescents, a time-dependent reduction in systemic exposure, which plateaus by approximately week 6 is observed.
Slovenian: Poleg tega so pri uporabi ponavljajočih se odmerkov modafinila pri otrocih in mladostnikih opazili zmanjšanje sistemske izpostavljenosti, odvisno od časa, ki doseže plato do približno šestega tedna.
English: In the placebo controlled studies, various cardiovascular events occurred almost exclusively in the modafinil treated group.
Slovenian: V študijah, nadzorovanih s placebom, so se različni srčno-žilni dogodki pojavljali skoraj izključno v skupini, ki se je zdravila z modafinilom.