natgillin/translations-raw huggingface dataset:
• You have sudden difficulty breathing or wheeziness or your face, mouth or throat begins to swell.
• imate nenadne težave z dihanjem ali zasoplost ali pa vaš obraz, usta ali grlo začnejo zatekati;
Contact your nearest hospital casualty department or tell your doctor or pharmacist immediately.
Takoj se obrnite na najbližji urgentni oddelek bolnišnice ali obvestite zdravnika ali farmacevta.
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.
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.
Modafinil promotes wakefulness in a variety of species, including man.
Modafinil spodbuja budnost pri različnih vrstah, vključno s človekom.
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.
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.
There are no factors that are known to predict the risk of occurrence or the severity of multi-organ hypersensitivity reactions associated with modafinil.
Ni dejavnikov, s katerimi bi lahko predvideli tveganje pojava ali resnost multiorganskih preobčutljivostnih reakcij, povezanih z modafinilom.
The CHMP Scientific Advisory Group (SAG) was also consulted.
CHMP se je posvetoval tudi z znanstveno svetovalno skupino (SAG) pri CHMP.
The wake-promoting effects of modafinil are antagonised by D1/D2 receptor antagonists suggesting that it has indirect agonist activity.
Učinki spodbujanja budnosti modafinila zavirajo antagonisti receptorjev D1/D2, kar kaže na njegovo posredno agonistično dejavnost.
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.
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.
In light of this, and because of its known safety profile, the demonstrated benefit is outweighed by the risks.
Zaradi tega in zaradi znanega varnostnega profila je prikazana prednost premajhna, da bi odtehtala tveganja.
Reproduction toxicity studies revealed no effect on fertility, nor any teratogenic effect, nor any effect on viability, growth or development of the offspring.
Študije reproduktivne toksičnosti niso pokazale učinka na plodnost, teratogenega učinka in učinkov na viabilnost, rast ali razvoj potomcev.
The recommended starting daily dose is 200 mg.
Priporočeni začetni dnevni odmerek je 200 mg.
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.
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.
While modafinil is not currently approved for paediatric use, a number of serious adverse reactions have been reported in children.
Čeprav modafinil trenutno ni odobren za pediatrično uporabo, so poročali o številnih neželenih učinkih pri otrocih.
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.
Če ste prizadeti ali ugotovite, da ste vseeno zelo zaspani, ko uporabljate to zdravilo, ne poskušajte voziti ali upravljati strojev.
Prothrombin times should be monitored regularly during the first 2 months of modafinil use and after changes in modafinil dosage.
Protrombinski časi naj se redno nadzorujejo med prvima dvema mesecema uporabe modafinila in po spremembah njegovega odmerka.
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.
Zdravila, ki vsebujejo modafinil, in nekatera druga zdravila lahko vplivajo drugo na drugo, zato bo morda zdravnik moral prilagoditi odmerke, ki jih jemljete.
The active ingredient in the tablets is modafinil.
Zdravilna učinkovina v tabletah je modafinil.
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.
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.
Antidepressants: A number of tricyclic antidepressants and selective serotonin reuptake inhibitors are largely metabolised by CYP2D6.
Antidepresivi: Več tricikličnih antidepresivov in selektivnih zaviralcev ponovnega privzema serotonina se večinoma presnavlja s CYP2D6.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH
Fertility No data on fertility are available.
Plodnost Podatki o plodnosti niso na voljo.
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.
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.
The outcomes of this study should be: first occurrence of myocardial infarction, cardiovascular death, cardiovascular hospitalisation and all cause mortality.
Izidi te študije morajo biti: prvi pojav miokardnega infarkta, smrt zaradi srčno-žilnega dogodka, hospitalizacija zaradi srčno-žilnega dogodka in smrtnost zaradi vseh vzrokov.
- Obstructive Sleep Apnoea (OSA), approved in 11 Member States;
- obstruktivno apnejo med spanjem (OSA) - odobrena v 11 državah članicah;
Your doctor will need to check these regularly while you are taking Modafinil containing medicinal products.
Vaš zdravnik bo to redno preverjal, ko boste jemali zdravila, ki vsebujejo modafinil;
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.
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.
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.
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.
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.
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.
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.
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.
The excretion of modafinil and its metabolites is chiefly renal, with a small proportion being eliminated unchanged (< 10% of the dose).
Izločanje modafinila in njegovih presnovkov večinoma poteka v ledvicah, majhen delež pa se izloči nespremenjen (< 10 % odmerka).
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.
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.
Pharmacotherapeutic group: Psychoanaleptic, centrally acting sympathomimetic, ATC code: N06BA
Farmakoterapevtska skupina: Psihoanaleptični simpatomimetiki z osrednjim delovanjem, oznaka ATC: N06BA
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.
Taka ocena je navadno sestavljena iz - poleg anamneze bolnika - testiranja z meritvami spanja v laboratorijskem okolju in z izključitvijo drugih možnih vzrokov opažene hipersomnije.
Narcolepsy is a condition that causes excessive daytime sleepiness and a tendency to fall asleep suddenly in inappropriate situations (sleep attacks).
Narkolepsija je stanje, ki povzroči pretirano zaspanost podnevi in nagnjenost k temu, da človek zaspi nenadoma in v neprimernih situacijah (napadi spanja).
Modafinil may increase its own metabolism via induction of CYP3A4/5 activity but the effect is modest and unlikely to have significant clinical consequences.
Modafinil lahko poveča lastni metabolizem z indukcijo CYP3A4/5, vendar pa so učinki zmerni in ni verjetno, da bodo imeli pomembne klinične posledice.
The other indications for modafinil are excessive sleepiness associated with:
Druge indikacije za uporabo modafinila so čezmerna zaspanost, povezana z:
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.
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.
Administration of modafinil results in electrophysiological changes indicative of increased alertness and improvements in objective measures of ability to sustain wakefulness.
Uporaba modafinila povzroči elektrofiziološke spremembe, ki kažejo na povečano budnost in izboljšanje objektivnih meril za sposobnost vzdrževanja budnosti.
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.
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.
The MAHs will continue to perform surveillance of severe skin reactions in the German Severe Cutaneous Adverse Reactions (SCAR) registry.
Imetniki dovoljenj za promet z zdravili bodo še naprej spremljali hude kožne reakcije v nemškem registru resnih kožnih neželenih učinkov (SCAR).
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).
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.
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.
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.
Available pharmacodynamic/toxicological data in animals have shown excretion of Modafinil/metabolites in milk (for details see 5.3).
Razpoložljivi farmakodinamski/toksikološki podatki pri živalih so pokazali izločanje modafinila/presnovkov v mleku (za podrobnosti glejte poglavje 5.3).
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.
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.
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).
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).
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.
Če pozabite vzeti zdravilo, ki vsebuje modafinil Če pozabite vzeti zdravilo, vzemite naslednji odmerek ob običajnem času.
Very common side effects (affecting more than 1 in 10 people): • Headache
Zelo pogosti neželeni učinki (pojavijo se pri več kot 1 od 10 bolnikov): - glavobol.
The percentage of patients experiencing a psychiatric adverse event in clinical trials is also significant, particularly when compared to placebo.
Odstotek bolnikov s psihiatričnimi neželenimi učinki je bil pomemben tudi v kliničnih preskušanjih, zlasti v primerjavi s placebom.
• The opinion did not accurately reflect the data supporting the efficacy of Modafinil in the indication excessive sleepiness associated with obstructive sleep apnoea.
• Mnenje ni natančno odražalo podatkov, ki podpirajo učinkovitost modafinila za indikacijo čezmerne zaspanosti v povezavi z obstruktivno apnejo med spanjem.
Modafinil is well-absorbed with peak plasma concentration reached approximately two to four hours after administration.
Modafinil se dobro absorbira in doseže največjo koncentracijo v plazmi po približno dveh do štirih urah po uporabi.
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.
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.
An ECG is recommended in all patients before Modafinil treatment is initiated.
Pri vseh bolnikih se priporoča EKG pred začetkom zdravljenja z modafinilom.
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.
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.
Treatment should be initiated by or under the supervision of a physician with appropriate knowledge of indicated disorders (see section 4.1).
Zdravljenje mora začeti zdravnik z ustreznim znanjem o indiciranih motnjah ali mora biti pod njegovim nadzorom (glejte poglavje 4.1).
Toxicology studies by single and repeated dosing have revealed no particular toxic action in animals.
Toksikološke študije enkratnega odmerka in ponavljajočih se odmerkov pri živalih niso pokazale določenega toksičnega delovanja.
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.
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.
Further information should also be collected on use in pregnancy and lactation, potential for abuse/misuse and diversion and off-label use.
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.
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.
Poleg tega je potrebna kontraindikacija pri bolnikih z nenadzorovano hipertenzijo ali srčno aritmijo, da se preprečijo resni zapleti pri bolnikih s takšnimi sočasnimi boleznimi.
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.
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.
However, modafinil binds to the norepinephrine transporter and inhibits norepinephrine uptake, but these interactions are weaker than those observed with the dopamine transporter.
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.
As a result, the product information for modafinil was updated across Europe to include strengthened warnings.
Posledično so v Evropi posodobili informacije o zdravilih, ki vsebujejo modafinil, tako da so vključili okrepljena opozorila.
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.
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.
The 400 mg dose in study 303 did not lead to higher MWT differences or improved ESS score than the 200 mg dose.
Odmerek 400 mg v študiji 303 ni povzročil večjih razlik v rezultatih testa MWT ali izboljšanja vrednosti ESS v primerjavi z odmerkom 200 mg.
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.
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.
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.
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.
In study 402, MSLT increased from 7.6 minutes at baseline to 8.6 minutes.
V študiji 402 so se rezultati multiplega testa latence uspavanja (MSLT) povečali s 7,6 minute v izhodišču na 8,6 minute.
Following the CHMP conclusion and recommendations for modafinil-containing medicinal products, one MAH submitted detailed grounds for the re-examination of the CHMP opinion.
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.
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.
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.
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.
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.
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.
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.
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.
Vendar so bile koristi modafinila pri narkolepsiji jasno in pomembno dokazane v dvojno zaslepljenih, nadzorovanih preskušanjih z objektivnimi in subjektivnimi meritvami.
Sexually active women of child-bearing potential should be established on a contraceptive programme before taking modafinil.
Spolno aktivne ženske v rodni dobi naj začnejo program kontracepcije, preden začnejo jemati modafinil.
Examples include ciclosporin, HIV-protease inhibitors, buspirone, triazolam, midazolam and most of the calcium channel blockers and statins.
Med njimi so ciklosoporin, inhibitorji proteaze HIV, buspiron, triazolam, midazolam ter večina zaviralcev kalcijevih kanalčkov in statinov.
In patients deficient in CYP2D6 (approximately 10% of a Caucasian population) a normally ancillary metabolic pathway involving CYP2C19 becomes more important.
Pri bolnikih, ki imajo deficienco CYP2D6 (približno 10 % belske populacije), postanejo pomembnejše presnovne poti s CYP2C19, ki so običajno pomožne.
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.
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.