natgillin/translations-raw huggingface dataset:
The study should be started within 2 months of the Commission Decision, and the final report should be submitted within 6 months of study initiation.
Študija se mora začeti v 2 mesecih po sprejetju odločbe Komisije, končno poročilo pa mora biti predloženo v 6 mesecih po začetku študije.
If you need to take it for a long time your doctor will check regularly that it is still the best medicine for you.
Če ga morate jemati dlje časa, bo vaš zdravnik redno preverjal, ali je to še vedno najboljše zdravilo za vas.
For patients 6 to 7 years of age, the estimated half-life is approximately 7 hours and increases with increase in age until half-life values approach those in adults (approximately 15 hours).
Pri bolnikih, starih od 6 do 7 let, je ocenjen razpolovni čas približno 7 ur in se povečuje s starostjo, dokler se vrednosti razpolovnega časa ne približajo vrednostim pri odraslih (približno 15 ur).
Food has no effect on overall modafinil bioavailability; however, absorption (tmax) may be delayed by approximately one hour if taken with food.
Hrana nima nobenega vpliva na splošno biološko uporabnost modafinila, vendar pa se lahko absorpcija (tmax) upočasni za približno eno uro, če se vzame s hrano.
A diagnosis of narcolepsy should be made according to the International Classification of Sleep Disorders (ICSD2) guideline.
Diagnozo narkolepsije je treba postaviti skladno s smernico Mednarodne klasifikacije spalnih motenj (International Classification of Sleep Disorders - ICSCD 2).
Modafinil should not be used in children aged less than 18 years old because of safety and efficacy concerns (see section 4.4).
Modafinil naj se ne uporablja pri otrocih, mlajših od 18 let, zaradi pomislekov glede varnosti in učinkovitosti (glejte poglavje 4.4).
In view of the potential for lower clearance and increased systemic exposure, it is recommended that patients over 65 years of age commence therapy at 100 mg daily.
Glede na možnost manjšega očistka in povečane sistemske izpostavljenosti se priporoča, da se zdravljenje pri bolnikih, starejših od 65 let, začne z odmerkom 100 mg na dan.
It is therefore appropriate that treatment with modafinil always starts with the lowest recommended dose (200 mg) and be increased up to 400 mg only in patients with insufficient response.
Zato je primerno, da se zdravljenje z modafinilom vedno začne z najmanjšim priporočenim odmerkom (200 mg) in se poveča do 400 mg le pri bolnikih z nezadostnim odzivom.
Luxembourg ORGANON N.V Kloosterstraat 6
Luksemburg ORGANON N.V Kloosterstraat 6
Whilst studies with modafinil have demonstrated a potential for dependence, the possibility of dependence with long-term use cannot be entirely excluded.
Glede na to, da so študije modafinila pokazale potencial za odvisnost, možnosti odvisnosti pri dolgotrajni uporabi ni mogoče popolnoma izključiti.
Temporal association also contributes to the confirmation of causality.
Časovna povezava ravno tako prispeva k potrditvi vzročnosti.
The most commonly reported adverse drug reaction is headache, affecting approximately 21% of patients.
Neželeni učinek zdravila, o katerem so poročali najpogosteje, je glavobol, ki je prizadel približno 21 % bolnikov.
Psychotic or manic symptoms
Psihotični ali manični simptomi
Further consideration will be given to the use of databases in other EU countries, such as the Institute for Drug Outcomes Research (PHARMO) in the Netherlands and Cegedim in France.
Preučili bodo tudi zbirke podatkov v drugih državah EU, kot sta inštitut za raziskavo vpliva zdravil (Institute for Drug Outcomes Research, PHARMO) na Nizozemskem in Cegedim v Franciji.
Modafinil may improve your narcolepsy and reduce the likelihood that you will have sleep attacks but there may still be other ways that you can improve your condition and your doctor will advise you.
Modafinil lahko izboljša vašo narkolepsijo in zmanjša verjetnost, da boste imeli napade spanja, vendar pa obstajajo tudi drugi načini, da izboljšate svoje stanje, o čemer vam bo svetoval vaš zdravnik.
- Idiopathic hypersomnia (IH), approved in 4 Member States;
- idiopatsko hipersomnijo (IH) - odobrena v 4 državah članicah;
However, the clinical relevance of this increase is questionable as, at the end of the study, the patients would still be characterised as severely ill (severe illness according to ICSD-1 is usually associated to MSLT scores below 5).
Vendar je klinični pomen tega povečanja vprašljiv, saj bi bolnike na koncu študije še vedno lahko ocenili kot hudo bolne (huda bolezen je skladno z ICSD-1 običajno povezana z vrednostjo MSLT pod 5).
If the feasibility analysis shows that a scientifically valid, well-designed and suitable powered study is viable, then the MAHs commit to submit a detailed protocol within 2 months and to present the final study report within 6 months of completion of the study.
Če analiza izvedljivosti pokaže, da je znanstveno veljavna, dobro zasnovana in primerno močna študija možna, se imetniki dovoljenj za promet z zdravili zavezujejo k predložitvi podrobnega protokola v 2 mesecih ter končnega poročila o študiji v 6 mesecih po zaključku študije.
National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Nacionalni pristojni organi, ki jih po potrebi koordinira referenčna država članica, morajo zagotoviti, da imetniki dovoljenja za promet z zdravilom izpolnijo naslednje pogoje:
Patients should be advised that modafinil is not a replacement for sleep and good sleep hygiene should be maintained.
Bolnikom je treba povedati, da modafinil ni nadomestilo za spanje in da je treba vzdrževati dobro spalno higieno.
Tablets should be swallowed whole with water.
Tablete je treba pogoltniti cele z vodo.
Significant safety issues identified during this review (skin and hypersensitivity reactions, cardiovascular events) require further study.
Pomembne varnostne težave, ugotovljene v tem pregledu (kožne in preobčutljivostne reakcije, srčnožilni dogodki), zahtevajo dodatne študije.
In the rat peri-post-natal study, modafinil concentration in milk was about 11.5 times higher than in plasma.
V peri-post-natalnih študijah podgan je bila koncentracija modafinila v mleku približno 11,5-krat višja kot v plazmi.
The key messages have been agreed with CHMP and each Member State will ensure that the relevant information is included in the translation in their National Language, as applicable.
CHMP je potrdil ključna sporočila, vse države članice pa bodo zagotovile, da bodo pomembne informacije vključene v prevodih v nacionalne jezike, če je smiselno potrebno.
Undesirable effects such as blurred vision or dizziness might also affect ability to drive (see section 4.8).
Neželeni učinki, kot sta zamegljen vid in omotica, prav tako lahko vplivajo na sposobnost upravljanja vozil (glejte poglavje 4.8).
As in the narcolepsy studies, no dose response effect was observed.
Kot pri študijah narkolepsije tudi tukaj ni bil ugotovljen učinek odziva na odmerek.
The mechanism of action is not entirely understood, but the most consistent findings of the various studies performed are the inhibitory effects on the dopamine and norepinephrine transporters.
Mehanizem delovanja ni v celoti znan, vendar so najbolj dosledne ugotovitve različnih opravljenih študij zaviralni učinki na prenašalca dopamin in norepinefrin.
Your doctor will only increase your dose (up to the maximum 400 mg a day) provided that you do not have any liver or kidney problems
Vaš zdravnik bo povečal odmerek (do največ 400 mg na dan) samo v primeru, da nimate težave z jetri ali ledvicami.
It should be noted that none of the studies included an objective measurement of sleepiness in the inclusion criteria, which raises additional questions regarding the appropriateness of the population recruited.
Poudariti je treba, da v nobeni študiji niso za vključitveno merilo uporabili objektivne meritve zaspanosti, kar sproža dodatna vprašanja glede primernosti sodelujoče populacije.
Existing long term data are not controlled, are based on a subjective parameter and have failed to demonstrate a significant effect of modafinil.
Obstoječi dolgoročni podatki niso bili nadzorovani, temeljijo na subjektivnem parametru in niso uspeli dokazati pomembnega učinka modafinila.
The effective elimination half-life of modafinil after multiple doses is about 15 hours.
Učinkovit razpolovni čas izločanja modafinila po več odmerkih je približno 15 ur.
• The Committee considered all the available data submitted on the safety and the efficacy of modafinil-containing products.
• Odbor je upošteval vse razpoložljive podatke, predložene v zvezi z varnostjo in učinkovitostjo zdravil, ki vsebujejo modafinil.
Once the Commission Decision is issued, the MAHs must submit an updated version of the Risk Management Plan to the National Competent Authorities, taking into account all recommendations made by the CHMP during the procedure and including all the studies described as conditions of the marketing authorisation.
Ko bo izdana odločba Komisije, morajo imetniki dovoljenj za promet z zdravili nacionalnim pristojnim organom predložiti posodobljeno različico načrta za obvladovanje tveganja ob upoštevanju vseh priporočil CHMP med postopkom ter z vključitvijo vseh študij, ki so navedene kot pogoji dovoljenja za promet z zdravilom.
In addition, there were reports of suicidal ideation, hostility/aggression and psychotic episodes.
Poleg tega obstajajo poročila o samomorilnih mislih, sovražnosti/napadalnosti in psihotičnih epizodah.
Modafinil can be taken by adults who suffer from narcolepsy to help them to stay awake.
Modafinil lahko jemljejo odrasli, ki trpijo za narkolepsijo, da jim pomaga, da ostanejo budni.
Having considered the data presented, the CHMP recognises the existence of a consistent short-term effect of modafinil in all variables measured.
Ob upoštevanju predloženih podatkov CHMP priznava obstoj skladnih kratkotrajnih učinkov modafinila pri vseh izmerjenih spremenljivkah.
Patients should be monitored for the development of de novo or exacerbation of pre-existing psychiatric disorders (see below and Section 4.8) at every adjustment of dose and then regularly during treatment.
Bolnike je treba nadzorovati za razvoj de novo ali poslabšanje že obstoječih psihiatričnih motenj (glejte spodaj in poglavje 4.8) ob vsaki prilagoditvi odmerka in nato redno med zdravljenjem.
The chief metabolite (40 - 50% of the dose), modafinil acid, has no pharmacological activity.
Glavni presnovek (40-50 % odmerka), modafinilijeva kislina, nima nobene farmakološke aktivnosti.
The onset or worsening of aggressive or hostile behaviour can be caused by treatment with modafinil.
Pojav ali poslabšanje agresivnega ali sovražnega vedenja je lahko posledica zdravljenja z modafinilom.
It is however noted that the dose-response profile does not seem to be linear.
Vendar so ugotovili, da profil odziva na odmerek ni linearen.
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.
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.
SCIENTIFIC CONCLUSIONS Overall summary of the scientific evaluation of modafinil-containing products (see Annex I)
ZNANSTVENI ZAKLJUČKI Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo modafinil (glejte Dodatek I)
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.
Vendar so z vidika varnostnih zadržkov, odkritih v tem pregledu, obvezni ukrepi za zmanjševanje tveganja, da se zagotovi varna in učinkovita uporaba zdravila.
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.
Modafinil se zmerno veže na beljakovine v plazmi (približno 60 %), predvsem na albumin, kar kaže, da obstaja majhno tveganje interakcije z močno vezanimi zdravili.
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.
Če ste noseči (ali mislite, da ste) ali načrtujete nosečnost ali dojite, ne smete jemati zdravil, ki vsebujejo modafinil.
Maintenance of sleep hygiene
Vzdrževanje spalne higiene
Modafinil is not recommended for use during pregnancy or in women of childbearing potential unless they are using effective contraception.
Modafinil ni priporočen za uporabo med nosečnostjo ali pri ženskah v rodni dobi, če ne uporabljajo učinkovite kontracepcije.
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).
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.
1, cours du Triangle 92936 Paris la Défense Cedex
1, cours du Triangle 92936 Paris la Défense Cedex France
Because multi-organ hypersensitivity is variable in its expression, other organ system symptoms and signs, not noted here, may occur.
Ker se multiorganska preobčutljivost izraža različno, se lahko pojavijo simptomi in znaki drugih organskih sistemov, ki tu niso navedeni.
The pharmacokinetic properties of modafinil are linear and time-independent.
Farmakokinetične lastnosti modafinila so linearne in neodvisne od časa.
Overall, these studies provide proof of the short term efficacy of modafinil in treating excessive daytime sleepiness in patients with narcolepsy.
Na splošno ti študiji dokazujeta kratkoročno učinkovitost modafinila za zdravljenje čezmerne dnevne zaspanosti pri bolnikih z narkolepsijo.
The MAHs will provide, within 3 months of the Commission Decision, a feasibility analysis of an epidemiological cardiovascular safety study.
Imetniki dovoljenj za promet z zdravili bodo v 3 mesecih od odločbe Komisije predložili analizo izvedljivosti epidemiološke študije o srčno-žilni varnosti.
After 4 weeks of treatment, subjects in study 402 still presented with MSLT values below the normal (i.e. 10 minutes).
Po štirih tednih zdravljenja so imeli preiskovanci v študiji 402 vrednosti MSLT še vedno pod normalno vrednostjo (tj. 10 minut).
• Some people have reported having suicidal or aggressive thoughts or behaviour while taking this medicine.
• Nekateri bolniki so med jemanjem tega zdravila poročali o samomorilnih ali agresivnih mislih ali vedenju.
Multi-organ hypersensitivity reaction
Multiorganska preobčutljivostna reakcija
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.
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.
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.
Odmerki do 400 mg v enem ali dveh razdeljenih odmerkih se lahko uporabijo pri bolnikih z nezadostnim odzivom na začetni odmerek 200 mg modafinila.
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.
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.
Your doctor will review your treatment regularly to check that it is right for you.
Vaš zdravnik bo redno preučil vaše zdravljenje, da preveri, ali je to primerno za vas.
Do not take this medicine after the expiry date which is stated on the blister strip and the outer pack after ‘Exp'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem traku in zunanji ovojnini za besedo »Exp«.
Modafinil is not considered to be mutagenic or carcinogenic.
Menijo, da modafinil ni mutagen ali kancerogen.
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.
CHMP je po posvetovanju s SAG menil, da učinki na subjektivna in objektivna merila ne zagotavljajo jasnega dokaza o splošnem koristnem učinku.
Adequate contraception will require continuation of these methods for two months after stopping modafinil.
Ustrezna kontracepcija zahteva nadaljevanje teh metod dva meseca po prenehanju jemanja modafinila.
- Moderate to severe chronic shift work sleep disorder (SWSD), approved in 10 Member States.
- zmerno do hudo kronično motnjo spanja zaradi izmenskega dela (SWSD) - odobrena v 10 državah članicah.
Modafinil should not be used during breast feeding.
Modafinil se ne sme uporabljati med dojenjem.
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.
Zlasti podatki iz kliničnih preskušanj so povzročili zadržke zaradi tveganja resnih obolenj kože, ki zahtevajo hospitalizacijo, v povezavi z uporabo modafinila pri otrocih.
• The opinion adopted a Product Information which did not fully reflect the safety information for modafinil
• V mnenju so bile sprejete informacije o zdravilu, ki ne odražajo popolnoma varnostnih informacij za modafinil.
Although there have been a limited number of reports, multi-organ hypersensitivity reactions may result in hospitalization or be life-threatening.
Čeprav obstaja omejeno število poročil, imajo lahko multiorganske preobčutljivostne reakcije za posledico hospitalizacijo ali pa so življenjsko nevarne.
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.
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).
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.
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.
• Have uncontrolled, moderate to severe high blood pressure (hypertension).
• če imate nenadzorovan zmerno do resno visok krvni tlak (hipertenzijo).
The tablets also contain [to be completed nationally] as inactive ingredients.
Tablete poleg tega vsebujejo [izpolni država članica] kot pomožne snovi.
Adults with severe kidney and liver problems The usual dose is 100 mg a day.
Odrasli s hudimi težavami z ledvicami ali jetri Običajni odmerek je 100 mg na dan.
The Summary of Product Characteristics should also clearly mention that modafinil is not recommended for use in children and during pregnancy and lactation.
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.
There was no effect on fertility and no evidence of teratogenic potential at systemic exposures equivalent to the maximum recommended human dose.
Ni bilo učinka na plodnost in dokazov za teratogeni potencial pri sistemski izpostavitvi, enakovredni največjemu priporočenemu odmerku za ljudi.
Modafinil does not appear to be a direct 1-adrenoceptor agonist.
Ne zdi se, da bi bil modafinil neposredni agonist 1-adrenoreceptorja.
Maintenance of the efficacy in the long term has not been demonstrated, as the existing long term data is uncontrolled.
Ohranitev dolgoročne učinkovitosti ni bila dokazana, saj obstoječi dolgoročni podatki niso bili nadzorovani.
Systemic exposure increases in a dose proportional manner over the range of 200-600 mg.
Sistemska izpostavljenost se poveča skladno z odmerkom, od 200-600 mg.
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.
Ob upoštevanju predloženih podatkov je Odbor mnenja, da je modafinil povezan z redkim tveganjem resnih, smrtno nevarnih kožnih reakcij.
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.
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.
• Are allergic (hypersensitive) to modafinil, or to any of the other ingredients of these tablets (see section 6 ‘What Modafinil containing medicinal products contains').
• če ste alergični (preobčutljivi) na modafinil ali na katerokoli sestavino teh tablet (glejte poglavje 6 »Kaj vsebujejo zdravila, ki vsebujejo modafinil«);
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.
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.
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.
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.
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
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.
The large number of spontaneous reports seems to support this association.
Zdi se, da to povezavo podpira veliko število spontanih poročil.
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.
Ta razlika pri očistku je delno posledica manjše velikosti in manjše telesne mase mlajših bolnikov, ki povzročita primerljivo izpostavljenost po uporabi primerljivih odmerkov.
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.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
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.
Dolgoročna učinkovitost ravno tako ni bila dokazana, saj obstoječi dolgoročni podatki niso bili nadzorovani in so bili izmerjeni samo subjektivni parametri.
Excessive sleepiness is defined as difficulty maintaining wakefulness and an increased likelihood of falling asleep in inappropriate situations.
Čezmerna zaspanost je opredeljena kot težko vzdrževanje budnosti in povečana verjetnost, da bo bolnik zaspal v neprimernih situacijah.