natgillin/translations-raw huggingface dataset:
Patient monitoring and clinical assessment of the need for treatment should be performed on a periodic basis.
Bolnike je treba periodično spremljati in klinično ocenjevati glede potrebe po zdravljenju.
Multi-organ hypersensitivity reactions, including at least one fatality in post-marketing experience, have occurred in close temporal association to the initiation of modafinil.
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.
Other things to talk to your doctor or pharmacist about
Druge stvari, o katerih se morate pogovoriti z zdravnikom ali s farmacevtom
Severe rashes may cause blistering or peeling of the skin, ulcers in your mouth, eyes, nose or genitals.
Resni izpuščaji lahko povzročijo tudi mehurje ali lupljenje kože, razjede v ustih, očeh, na nosu ali genitalijah.
Almost half of all the adverse events reported for modafinil appear to be reported in use outside of the approved indications.
Videti je, da so pri skoraj polovici vseh poročil o neželenih učinkih modafinila poročali v zvezi z uporabo zunaj odobrenih indikacij.
Modafinil is associated with the onset or worsening of anxiety.
Modafinil je povezan z nastopom ali poslabšanjem anksioznosti.
In humans, modafinil restores and/or improves the level and duration of wakefulness and daytime alertness in a dose-related manner.
Pri ljudeh modafinil na način, povezan z odmerkom, ponovno vzpostavi in/ali izboljša stopnjo in trajanje budnosti in dnevne živahnosti.
Patients with abnormal levels of sleepiness who take modafinil should be advised that their level of wakefulness may not return to normal.
Bolniki z nenormalnimi ravnmi zaspanosti, ki jemljejo modafinil, naj upoštevajo, da se njihova raven budnosti morda ne bo vrnila na normalno.
As modafinil may reduce the effectiveness of oral contraception alternative additional methods of contraception are required (see section 4.5).
Ker lahko modafinil zmanjša učinkovitost peroralne kontracepcije, so zahtevane dodatne alternativne kontracepcijske metode (glejte razdelek 4.5.)
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
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
Once steady-state is reached, the pharmacokinetic properties of modafinil do not appear to change with continued administration for up to 1 year.
Ko se doseže stanje dinamičnega ravnovesja, se farmakokinetične lastnosti modafinila ob neprekinjeni uporabi ne spreminjajo do enega leta.
Modafinil- containing medicinal products is indicated in adults for the treatment of excessive sleepiness associated with narcolepsy with or without cataplexy.
Zdravila, ki vsebujejo modafinil, so pri odraslih indicirana za zdravljenje čezmerne zaspanosti, povezane z narkolepsijo s katapleksijo ali brez nje.
This syndrome may present with ischaemic ECG changes, chest pain or arrhythmia.
Ta sindrom se lahko pojavi z ishemičnimi spremembami EKG, bolečinami v prsih ali aritmijo.
In fact, no statistically significant difference was noted between the two modafinil doses used (200 and 400 mg) in any of the measurements.
Dejansko pri nobeni od meritev ni bilo statistično pomembne razlike med dvema uporabljenima odmerkoma modafinila (200 mg in 400 mg).
This circumstance is the result of metabolic auto-induction noted in the pre-clinical studies.
To je posledica samodejne presnovne indukcije, ki so jo opazili v predkliničnih študijah.
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.
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.
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).
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).
Uncontrolled moderate to severe hypertension and in patients with cardiac arrhythmias.
Nenadzorovana zmerna do huda hipertenzija in bolniki s srčnimi aritmijami.
Patients with major anxiety should only receive treatment with modafinil in a specialist unit.
Bolniki s hudo anksioznostjo se smejo z modafinilom zdraviti le v za to specializirani enoti.
As modafinil may inhibit CYP2C19, lower doses of antidepressants may be required in such patients.
Ker lahko modafinil zavira CYP2C19, so lahko pri teh bolnikih potrebni manjši odmerki antidepresivov.
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).
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).
Like all medicines, Modafinil containing medicinal products can cause side effects, although not everybody gets them.
Kot vsa zdravila imajo lahko tudi zdravila, ki vsebujejo modafinil, neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Modafinil is associated with the onset or worsening of psychotic symptoms or manic symptoms (including hallucinations, delusions, agitation or mania).
Modafinil je povezan z nastopom ali poslabšanjem psihotičnih simptomov ali maničnih simptomov (vključno s halucinacijami, blodnjami, agitacijo ali manijo).
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.
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.
No serious skin rashes have been reported in adult clinical trials (0 per 4,264) of modafinil.
Pri kliničnih študijah pri odraslih niso poročali o hudih kožnih izpuščajih (0 od 4264).
ORCHID EUROPE LTD Building 3, Chiswick park
ORCHID EUROPE LTD Building 3, Chiswick park 556, Chiswick High Road London
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.
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.
In the placebo controlled studies, various cardiovascular events occurred almost exclusively in the modafinil treated group.
V študijah, nadzorovanih s placebom, so se različni srčno-žilni dogodki pojavljali skoraj izključno v skupini, ki se je zdravila z modafinilom.
While modafinil is not a directacting dopamine receptor agonist, in vitro and in vivo data indicate that modafinil binds to the dopamine transporter and inhibits dopamine reuptake.
Medtem ko modafinil ni neposredno delujoči agonist receptorjev dopamina, podatki in vitro in in vivo kažejo, da se modafinil veže na prenašalca dopamina in zavira ponovni privzem dopamina.
Hospitalisation and surveillance of psychomotor status; cardiovascular monitoring or surveillance until the patient's symptoms have resolved are recommended.
Priporočajo se hospitalizacija in nadzor psihomotoričnega stanja, srčno-žilni nadzor ali opazovanje, dokler simptomi ne minejo.
While improvement was reported on the number of accidents or near accidents during the commute, no account was taken for the type or duration of the commute and no baseline values were collected.
Poročali so o izboljšanju števila nezgod ali skorajšnjih nezgod med prevozom na delo, vendar pa ni bila upoštevana vrsta ali trajanje prevoza, ravno tako pa niso bile zbrane izhodiščne vrednosti.
- If you get any side effects which worry you, talk to your doctor, pharmacist or nurse.
- Če dobite katerikoli neželeni učinek, ki vas skrbi, se pogovorite z zdravnikom, farmacevtom ali medicinsko sestro.
Uncommon: hypercholesterolaemia, hyperglycaemia, diabetes mellitus, increased appetite,
Občasni: hiperholesterolemija, hiperglikemija, diabetes mellitus, povečan apetit
• Have ever had depression, low mood, anxiety, psychosis (loss of contact with reality) or mania (over-excitement or feeling of extreme happiness) or bipolar disorder because Modafinil containing medicinal products may make your condition worse.
• če ste kdajkoli imeli depresijo, poslabšano razpoloženje, napad tesnobe, psihozo (izgubo stika z realnostjo) ali manijo (preveliko razburjenje ali občutek izjemne sreče) ali bipolarno motnjo, saj zdravila, ki vsebujejo modafinil, lahko poslabšajo vaše stanje;
Modafinil also does not inhibit the activities of adenylyl cyclase, catechol-O-methyltransferase, glutamic acid decarboxylase MAO-A or B, nitric oxide synthetase, phosphodiesterases II-VI, or tyrosine hydroxylase.
Modafinil prav tako ne zavira adenililciklaze, katehol-O-metiltransferaze, dekarboksilaze glutaminske kisline, MAO-A ali B, sintetaze dušikovega oksida, fosfodiesteraz II-VI ali tirozin-hidroksilaze.
While small short-term improvements could be observed in objective sleep measurements, the more pronounced effects were seen in subjective measurements of sleepiness.
Čeprav so opazili majhna kratkotrajna izboljšanja pri objektivnih meritvah spanja, so bili bolj izraženi učinki pri subjektivnih meritvah zaspanosti.
6.2 Incompatibilities [To be completed nationally]
6.2 Inkompatibilnost [Izpolni država članica]
The effects of modafinil on the subjective sleepiness should be interpreted with caution, due to possible unblinding of treatment during the trials because of the neuropsychiatric profile of modafinil.
Učinke modafinila na subjektivno zaspanost je treba interpretirati previdno zaradi možnega prenehanja zaslepljenosti zdravljenja med preskušanji zaradi nevropsihiatričnega profila modafinila.
Note: This SPC and package leaflet is the version valid at the time of Commission Decision.
Opomba: Ta različica povzetka glavnih značilnosti zdravila in navodila za uporabo je različica, ki je veljavna ob izdaji sklepa Evropske komisije.
This medicinal product is authorised in the Member States of the EEA under the following names: [See Annex I - To be completed nationally]
Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: [Glejte Dodatek I - Izpolni država članica]
Common: abnormal liver function tests, dose related increases in alkaline phosphatase and gamma glutamyl transferase have been observed.
Pogosti: opaženi so bili nenormalni testi jetrne funkcije, z odmerkom povezana povišanja ravni alkalne fosfataze in gama-glutamil transferaze
• The Committee considered that there are significant risks associated to modafinil use, including risk of serious cardiovascular disorders, neuropsychiatric disorders and skin and hypersensitivity disorders.
• Odbor je menil, da obstajajo pomembna tveganja, povezana z uporabo modafinila, vključno s tveganjem resnih srčno-žilnih bolezni, nevropsihiatričnih motenj ter kožnih in preobčutljivostnih motenj.
However, animal exposure on a mg/kg dose basis to modafinil in the general toxicology, reproductive and carcinogenicity studies was greater than the expected exposure, calculated on a similar basis, in humans.
Vendar pa je bila izpostavljenost živali glede na mg/kg modafinila pri študijah splošne toksičnosti, razmnoževanja in kancerogenosti večja kot pričakovana izpostavljenost pri ljudeh, izračunana na podobni podlagi.
Patients using steroidal contraceptives
Bolniki, ki uporabljajo hormonsko kontracepcijo
Animal exposure to modafinil, based on actual plasma levels in the general toxicology, reproductive and carcinogenicity studies, was less than or similar to that expected in humans.
Izpostavljenost živali modafinilu, ki temelji na dejanskih ravneh v plazmi pri študijah splošne toksičnosti, razmnoževanja in kancerogenosti, je bila manjša ali podobna kot pričakovane koncentracije pri ljudeh.
Modafinil tablets are not recommended in patients with a history of left ventricular hypertrophy or cor pulmonale and in patients with mitral valve prolapse who have experienced the mitral valve prolapse syndrome when previously receiving CNS stimulants.
Tablete modafinila niso priporočene za bolnike z anamnezo hipertrofije levega prekata ali cor pulmonale in pri bolnikih s prolapsom mitralne zaklopke, pri katerih se je sindrom prolapsa mitralne zaklopke pojavil med predhodnim zdravljenjem s stimulansi osrednjega živčevja.
In clinical trials, all the hypersensitivity related terms were reported more commonly in association to modafinil than to placebo.
V kliničnih preskušanjih so o vseh izrazih, povezanih s preobčutljivostjo, pogosteje poročali v povezavi z modafinilom kot s placebom.
The MAHs will access and submit data on the study on recreational use and diversion among university students in the UK, being developed by the Centre for Public Health, School of Pharmacy and Biomolecular Sciences - Liverpool John Moores University.
Imetniki dovoljenj za promet z zdravili bodo dostopali do podatkov študije rekreativne uporabe med univerzitetnimi študenti v Združenem kraljestvu, ki jo izvaja Center za javno zdravje pri Šoli za farmacevtske in biomolekularne znanosti na Univerzi Johna Mooresa v Liverpoolu, ter te podatke predložili.
Steroidal contraceptives: The effectiveness of steroidal contraceptives may be impaired due to induction of CYP3A4/5 by modafinil.
Hormonska kontracepcija: Učinkovitost hormonske kontracepcije se lahko zmanjša zaradi indukcije CYP3A4/5 z modafinilom.
In 2007, concerns relating to serious psychiatric disorders (suicidal thoughts/behaviour, symptoms of psychosis and mania) and serious skin and subcutaneous tissue disorders (including erythema multiforme and Stevens-Johnson syndrome) prompted a review of the available data from clinical trials and spontaneous adverse reaction reports by the Pharmacovigilance Working Party (PhVWP).
Leta 2007 so zadržki zaradi resnih psihiatričnih motenj (samomorilne misli/vedenje, simptomi psihoze in manije) ter resnih obolenj kože in podkožja (vključno z multiformnim eritemom in Stevens-Johnsonovim sindromom) privedli do tega, da je delovna skupina za farmakovigilanco začela pregled razpoložljivih podatkov iz kliničnih preskušanj in spontanih poročil o neželenih učinkih.
WHAT MODAFINIL CONTAINING MEDICINAL PRODUCTS IS AND WHAT IT IS USED FOR
KAJ SO ZDRAVILA, KI VSEBUJEJO MODAFINIL, IN ZA KAJ JIH UPORABLJAMO
There are limited data available on the use of modafinil in elderly patients.
Podatkov o uporabi modafinila pri starejših bolnikih je malo.
Shift Work Sleep Disorder
Motnja spanja zaradi izmenskega dela
In placebo controlled studies in this indication, 6 patients withdrew from the modafinil group due to a cardiovascular adverse event while only one patient withdrew in the placebo group.
V študijah za to indikacijo, nadzorovanih s placebom, se je iz skupine, ki je prejemala modafinil, zaradi srčno-žilnega neželenega dogodka umaknilo 6 preiskovancev, iz skupine, ki je prejemala placebo, pa se je umaknil en bolnik.
The cardiovascular comorbidities in OSA lead to difficulties in interpreting this observation.
Sočasne srčno-žilne bolezni pri OSA otežujejo interpretacijo te ugotovitve.
In study 305 (a phase 3 randomised, double-blind, placebo-controlled study), a modest but statistically significant improvement was observed in the MSLT score.
V študiji 305 (randomizirani, dvojno zaslepljeni, s placebom nadzorovani študiji 3. faze) so ugotovili skromno, vendar statistično pomembno izboljšanje vrednosti testa MSLT.
Although modafinil-induced wakefulness can be attenuated by the 1-adrenoceptor antagonist, prazosin, in other assay systems (e.g. vas deferens) responsive to -adrenoceptor agonists, modafinil is inactive.
Čeprav lahko antagonist 1-adrenoreceptorja, prazosin, zmanjša budnost, ki jo sproži modafinil, je bil v drugih sistemih testiranja (npr. semenovod), odzivnih na agoniste -adrenoreceptorja, modafinil neaktiven.
However, a higher incidence of cardiovascular adverse events when compared to placebo was observed in the modafinil clinical trials, seems to be consistent across the indications and is not seen exclusively in OSA patients.
Vendar se zdi, da je večja pojavnost srčno-žilnih neželenih dogodkov v primerjavi s placebom, ugotovljena v kliničnih preskušanjih modafinila, skladna pri vseh indikacijah in se ne pojavlja samo pri bolnikih z OSA.
In this assessment of the benefit-risk profile of modafinil in its different indications, the CHMP reviewed available data from pre-clinical and clinical studies, spontaneous reports, published literature and other data submitted by the MAHs as relevant.
CHMP je v tej oceni profila koristi in tveganja modafinila v različnih indikacijah pregledal podatke iz predkliničnih in kliničnih študij, spontanih poročil, objavljene literature in drugih informacij, ki so jih imetniki dovoljenj za promet z zdravili predložili kot pomembne.
This type of events was also observed in clinical trials, and frequently time to onset was suggestive of a temporal association with the product.
Tovrstne dogodke so opazili tudi v kliničnih preskušanjih, pri čemer je čas do nastopa kazal na časovno povezavo z zdravilom.
In non-clinical models, equal wakefulness-promoting doses of methylphenidate and amphetamine increase neuronal activation throughout the brain, whereas modafinil unlike classical psychomotor stimulants, predominantly affects brain regions implicated in regulating arousal, sleep, wake and vigilance.
Pri nekliničnih modelih so enaki odmerki metilfenidata in amfetamina, ki spodbujajo budnost, povečali aktivacijo nevronov v možganih, medtem ko je modafinil v nasprotju s klasičnimi psihomotoričnimi stimulansi vplival na območja v možganih, vpletena v uravnavanje vzburjenja, spanja, zbujanja in budnosti.
A causal association between hypersensitivity reactions and modafinil is supported both by postmarketing data and data from clinical trials.
Vzročno povezavo med preobčutljivostnimi reakcijami in modafinilom podpirajo podatki iz obdobja trženja zdravila in podatki iz kliničnih preskušanj.
In particular, the MAH discussed in their detailed grounds: o the clinical relevance of the differences observed on objective measures of wakefulness o whether the entry criteria of the studies were appropriate o the lack of supportive evidence of possible unblinding o the benefit for a specific subpopulation of patients
Imetnik dovoljenja za promet z zdravilom je v podrobni utemeljitvi razpravljal zlasti o: o kliničnem pomenu razlik, opaženih pri objektivnih merilih budnosti, o primernosti vključitvenih meril študij, o pomanjkanju podpornih dokazov možnega prenehanja zaslepljenosti, o koristi za specifično podskupino bolnikov.
Because of the newly identified risks of psychiatric and skin reactions in conjunction with cardiovascular risks, but also evidence of significant off label use and concerns about potential abuse, misuse or diversion, a formal review of the full benefit-risk balance of modafinil was initiated by the CHMP through an article 31 referral procedure.
Zaradi novo odkritih tveganj za psihiatrične in kožne reakcije v povezavi s kardiovaskularnimi tveganji ter dokazov o pomembni uporabi zunaj obsega indikacij in zadržkov o morebitni zlorabi, nepravilni uporabi in rekreativni uporabi je CHMP po napotitvi v skladu s členom 31 začel uraden pregled celotnega razmerja med koristmi in tveganji modafinila.
Pregnancy There is limited data on the use of modafinil in pregnant women.
Nosečnost Podatkov o uporabi modafinila pri nosečnicah je malo.
Caution should be exercised in giving modafinil to patients with a history of psychiatric disorders including psychosis, depression , mania, major anxiety, agitation, insomnia or substance abuse (see below).
Previdnost je potrebna pri dajanju modafinila bolnikom z anamnezo psihiatričnih motenj, vključno s psihozo, depresijo, manijo, večjo anksioznostjo, agitacijo, nespečnostjo ali zlorabo drog (glejte spodaj).
A fatal outcome was reported in 3 cases (cardiomyopathy, cardiac failure and syncope).
Poročali so o 3 primerih s smrtnim izidom (kardiomiopatija, srčno popuščanje in sinkopa).
Modafinil is a racemic compound, and the enantiomers have different pharmacokinetics where the elimination t1/2 of the R-isomer is three times that of the S-isomer in adult humans.
Enantiomeri imajo drugačno farmakokinetiko, kadar je pri odraslih ljudeh t1/2 eliminacije izomera R trikrat večji od t1/2 eliminacije izomera S.
Patients will abnormal findings should receive further specialist evaluation and treatment before Modafinil treatment is considered.
Bolnike z nenormalnimi rezultati naj dodatno ocenijo in zdravijo specialisti, preden se razmisli o zdravljenju z modafinilom.
The SAG considered that amongst OSA patients fully optimised on disease modifying treatment (such as CPAP) and in which all other causes of sleepiness have been treated, only a small subpopulation of patients could potentially benefit from modafinil treatment.
SAG je ugotovila, da je med bolniki z OSA, ki so bili vključeni v popolnoma optimizirano zdravljenje, ki spreminja potek bolezni (kot je CPAP), in so bili zdravljeni za vse ostale vzroke zaspanosti, le majhen delež bolnikov, ki bi lahko imelo koristi od zdravljenja z modafinilom.
• Have had alcohol or drug problems in the past.
• če ste imeli težave z zlorabo alkohola ali nedovoljenih drog.
In non-clinical models, modafinil has weak to negligible interactions with receptors involved in the regulation of sleep/wake states (e.g., adenosine, benzodiazepine, dopamine, GABA, histamine, melatonin, norepinephrine, orexin, and serotonin).
Pri nekliničnih modelih je imel modafinil šibke do zanemarljive interakcije z receptorji, vključenimi v uravnavanje stanja spanje/budnost (npr. adenozinom, benzodiazepinom, dopaminom, GABA, histaminom, melatoninom, noradrenalinom, oreksinom in serotoninom).
Infections and infestations Uncommon: pharyngitis, sinusitis
Infekcijske in parazitske bolezni Občasni: faringitis, sinusitis
It is noted that in a number of cases leading to discontinuation there was a very tight temporal association between modafinil and the events, and that in many cases the patients were young and had no known risk factors.
Treba je dodati, da so pri številnih preiskovancih, ki so prekinili sodelovanje v študiji, ugotovili tesno časovno povezavo med modafinilom in dogodki, v večini primerov pa so bili preiskovanci mladi in brez znanih dejavnikov tveganja.
Unknown: delusions
Neznana: blodnje
A significant number of adverse reactions relating to psychiatric disorders have been reported spontaneously.
Med spontanimi poročili je bilo pomembno število neželenih učinkov v zvezi s psihiatričnimi motnjami.
Modafinil should be discontinued at the first sign of rash and not restarted (see section 4.8).
Ob prvih znakih izpuščaja je treba zdravljenje z modafinilom prekiniti in se ne sme ponovno uvesti (glejte poglavje 4.8).