natgillin/translations-raw huggingface dataset:
Treatment with Nimvastid should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Zdravljenje z zdravilom Nimvastid mora uvesti in nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem alzheimerjeve bolezni ali demence pri bolnikih s parkinsonovo boleznijo.
Nimvastid is a ‘generic medicine'.
Zdravilo Nimvastid je „generično zdravilo“.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Nimvastid has been shown to have comparable quality and to be bioequivalent to Exelon.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Nimvastid primerljivo raven kakovosti kot zdravilo Exelon ter da mu je biološko enakovredno.
Nimvastid orodispersible tablets should be placed on the tongue, where they disintegrate quickly in the saliva before being swallowed.
Orodisprezibilne tablete Nimvastid se položijo na jezik, kjer se v slini hitro razgradijo, preden jih bolnik pogoltne.
Because Nimvastid is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Glede na to, da je Nimvastid generično zdravilo in je bioekvivalentno referenčnemu zdravilu, ima enake koristi in tveganja kot referenčno zdravilo.
Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Rivastigmin deluje tako, da zavira encime, ki razgrajujejo acetilholin: acetilholinesterazo in butirilholinesterazo.
Treatment should only be started if a caregiver is available who will regularly monitor the use of Nimvastid by the patient.
Zdravljenje se začne samo ob prisotnosti negovalca, ki redno nadzoruje uporabo zdravila Nimvastid pri bolniku.
Because Nimvastid is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine (this means that the two medicines produce the same levels of the active substance in the body).
Ker je zdravilo Nimvastid generično zdravilo, so bile študije omejene na preskuse, s katerimi se dokazuje, da je biološko enakovredno referenčnemu zdravilu (tj. da zdravili dosegata enake ravni zdravilne učinkovine v telesu).
It is also used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Zdravilo se lahko uporablja tudi za zdravljenje blage do zmerno hude demence pri bolnikih s parkinsonovo boleznijo.
By blocking these enzymes, Nimvastid allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia due to Parkinson's disease.
Zdravilo Nimvastid z blokiranjem teh encimov omogoča, da se ravni acetilholina v možganih povečajo, zaradi česar se simptomi alzheimerjeve demence in demence zaradi parkinsonove bolezni ublažijo.
Orodispersible means that the tablets dissolve in the mouth.
Orodisperzibilne tablete so tablete, ki se raztopijo v ustih.
Nimvastid is a medicine that contains the active substance rivastigmine.
Nimvastid je zdravilo, ki vsebuje zdravilno učinkovino rivastigmin.
In patients who tolerate this dose, it can be increased in 1.5-mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Pri bolnikih, ki prenašajo ta odmerek, se lahko ta postopoma povečuje za 1,5 mg, vendar ne pogosteje kot vsaka dva tedna, dokler se ne doseže stalnega odmerka 3 do 6 mg dvakrat na dan. Za dosego največje učinkovitosti se uporabi največji odmerek, ki ga bolnik še prenaša, vendar odmerek ne sme preseči 6 mg dvakrat na dan.
The active substance in Nimvastid, rivastigmine, is an antidementia medicine.
Zdravilna učinkovina zdravila Nimvastid je rivastigmin, ki je zdravilo za zdravljenje demence.
resulting in low levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other).
Pri bolnikih z alzheimerjevo demenco ali demenco zaradi parkinsonove bolezni v možganih odmrejo določene živčne celice, zaradi česar se znižajo ravni nevrotransmiterja acetilholina (kemične snovi, ki omogoča medsebojno komunikacijo med živčnimi celicami).
The full EPAR for Nimvastid can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Nimvastid je na voljo tukaj.
Therefore, the CHMP's view was that, as for Exelon, the benefit outweighs the identified risk.
Zato je CHMP menil, da koristi zdravila Nimvastid, tako kot pri zdravilu Exelon, odtehtajo znana tveganja.
What is Nimvastid?
Kaj je zdravilo Nimvastid?
How is Nimvastid used?
Kako se zdravilo Nimvastid uporablja?
What is Nimvastid used for?
Za kaj se zdravilo Nimvastid uporablja?
How has Nimvastid been studied?
Kako je bilo zdravilo Nimvastid raziskano?
How does Nimvastid work?
Kako zdravilo Nimvastid deluje?
Nimvastid should be given twice a day, with morning and evening meals.
Zdravilo Nimvastid se daje dvakrat na dan, ob zajtrkih in večerjah.
months).
(približno 10 mesecev).
This summary was last updated in 09-2011.
Povzetek je bil nazadnje posodobljen 09-2011.
As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 22 May 2008.
Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 22. maja 2008.
The European Commission granted a marketing authorisation valid throughout the European Union for Zevalin on 16 January 2004.
Evropska komisija je dovoljenje za promet z zdravilom Zevalin, veljavno po vsej Evropski uniji, odobrila dne 16. januarja 2004.
Zevalin was originally authorised under ‘exceptional circumstances' because it had not been possible to obtain complete information about Zevalin.
Zdravilo Zevalin je bilo prvotno odobreno v „izjemnih okoliščinah“, ker ni bilo mogoče pridobiti vseh informacij o njem.
The full EPAR for Zevalin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zevalin je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
However, the time taken for the disease to get worse after treatment was the same in both groups (about 10
Vendar pa je bil čas do poslabšanja bolezni po zdravljenju v obeh skupinah enak
The doctor who prescribes it must ensure that the risks linked to the exposure to the radioactivity are lower than the risks from the disease itself.
Zdravnik, ki ga predpiše, se mora prepričati, da so tveganja zaradi izpostavljenosti radioaktivnosti manjša od tveganj, ki izhajajo iz same bolezni.
Zevalin must be given as a slow infusion lasting 10 minutes.
Zdravilo Zevalin je treba dajati kot počasno infuzijo v trajanju 10 minut.
Other information about Zevalin
Druge informacije o zdravilu Zevalin
This is a summary of the European public assessment report (EPAR) for Zevalin.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zevalin.
For more information about treatment with Zevalin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Zevalin preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
The main measure of effectiveness was the length of time the patients survived without their disease getting worse.
Glavno merilo učinkovitosti je bil čas preživetja bolnika brez poslabšanja bolezni.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in certain cells in the body.
Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna posebno strukturo (imenovano antigen), ki jo najdemo v določenih celicah v telesu, in se veže nanjo.
EPAR summary for the public ibritumomab tiuxetan
Povzetek EPAR za javnost ibritumomab tiuksetan
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zevalin.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Zevalin, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What benefit has Zevalin shown during the studies?
Kakšne koristi je zdravilo Zevalin izkazalo med študijami?
In both studies, the main measure of effectiveness was the number of patients whose disease responded partially or completely to treatment.
V vseh študijah je bilo glavno merilo učinkovitosti število bolnikov s popolnim ali delnim odzivom na zdravljenje.
The study compared patients who received Zevalin and patients who received no additional treatment.
V študiji so primerjali bolnike, ki so prejeli Zevalin, in bolnike, ki niso prejeli nobenega dodatnega zdravljenja.
In the additional study, radiolabelled Zevalin brought about a response in about half of the patients.
Pri dodatni študiji je radioaktivno označeno zdravilo Zevalin povzročilo odziv pri približno polovici bolnikov.
However, there were too few patients who had received rituximab as part of their induction treatment to determine whether there would be a benefit of using Zevalin as consolidation treatment in these patients.
Vendar je premalo bolnikov prejelo rituksimab kot del indukcijskega zdravljenja, da bi lahko določili, ali bi jim uporaba zdravila Zevalin kot konsolidacijskega zdravljenja koristila.
This is followed, seven to nine days later, by a second infusion of rituximab and an injection of radiolabelled Zevalin.
Sedem do devet dni kasneje temu sledi nova infuzija rituksimaba in injekcija radioaktivno označenega zdravila Zevalin.
Zevalin should not be used in people who may be hypersensitive (allergic) to ibritumomab, yttrium chloride, mouse proteins or any of the other ingredients.
Zdravila Zevalin ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) ibritumomab, itrijev klorid, mišje beljakovine ali katero koli drugo sestavino zdravila.
Ibritumomab has been designed to target an antigen, CD20, which is present on the surface of all B lymphocytes.
Ibritumomab je bil zasnovan tako, da se veže na antigen CD20, ki je prisoten na površini vseh limfocitov B.
What is the risk associated with Zevalin?
Kakšna tveganja so povezana z zdravilom Zevalin?
Radiolabelled Zevalin treatment should only be handled and given by someone who is authorised to use radioactive medicines.
Z radioaktivno označenim zdravilom Zevalin smejo rokovati in ga dajati samo osebe, pooblaščene za uporabo radioaktivnih zdravil.
Zevalin is not used directly, but it must be radiolabelled before use.
Zdravilo Zevalin se ne uporablja neposredno, temveč ga je treba pred uporabo radioaktivno označiti.
In patients who were not responding to other treatments or whose disease had come back after previous treatment, Zevalin was more effective than rituximab: 80% of the patients receiving radiolabelled Zevalin responded, compared with 56% of the patients receiving rituximab.
Pri bolnikih, ki se niso odzivali na druga zdravljenja ali pri katerih se je bolezen po predhodnem zdravljenju ponovila, je bilo zdravilo Zevalin učinkovitejše od rituksimaba: odzvalo se je 80 % bolnikov, ki so prejemali radioaktivno označeno zdravilo Zevalin, v primerjavi s 56 % bolnikov, ki so prejemali rituksimab.
When Zevalin was used as consolidation therapy, patients survived for longer without their disease getting worse than when they received no further treatment.
Ko se je zdravilo Zevalin uporabilo kot konsolidacijska terapija, so bolniki preživeli dlje časa brez poslabšanja bolezni, kot če niso prejeli nobenega nadaljnjega zdravljenja.
Patients receiving radiolabelled Zevalin survived for an average of 37 months until their disease got worse, compared with 14 months in those who did not receive any further treatment.
Bolniki, ki so prejemali radioaktivno označeno zdravilo Zevalin, so v povprečju preživeli 37 mesecev do poslabšanja bolezni, v primerjavi s 14 meseci pri tistih bolnikih, ki niso prejemali nobenega nadaljnjega zdravljenja.
The dose of Zevalin is calculated to give the appropriate amount of radioactivity for the patient's condition, based on the blood cell count.
Odmerek zdravila Zevalin se izračuna tako, da bolniku zagotovi ustrezno količino radioaktivnosti glede na njegovo stanje, ugotovljeno na podlagi števila krvnih celic.
The Committee recommended that Zevalin be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Zevalin odobri dovoljenje za promet.
Radiolabelled Zevalin is radioactive and its use may carry a risk of cancer and hereditary defects.
Radioaktivno označeno zdravilo Zevalin je radioaktivno, njegova uporaba pa lahko pomeni tveganje za razvoj raka in dednih okvar.
Zevalin must not be used in patients who are pregnant or breast feeding.
Ne smejo ga uporabljati bolnice, ki so noseče ali dojijo.
For consolidation therapy, Zevalin has been studied in one main study involving 414 patients who had achieved a partial or complete remission during induction treatment for non Hodgkin's lymphoma.
Pri konsolidacijski terapiji so zdravilo Zevalin proučevali v eni glavni študiji, v katero je bilo vključenih 414 bolnikov, ki so dosegli delno ali popolno remisijo med indukcijskim zdravljenjem ne-Hodgkinovega limfoma.
The most common side effects with Zevalin (seen in more than 1 patient in 10) are anaemia (low red blood cell counts), leucocytopenia and neutropenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), asthenia (weakness), pyrexia (fever), rigors (stiffness) and nausea (feeling sick).
Najpogostejši neželeni učinki zdravila Zevalin (opaženi pri več kot 1 bolniku od 10) so slabokrvnost (nizka koncentracija rdečih krvničk), levkocitopenija in nevtropenija (nizka koncentracija belih krvničk), trombocitopenija (nizka koncentracija trombocitov), astenija (splošna oslabelost), pireksija (povišana telesna temperatura), rigor (okorelost) in navzeja (slabost).
For the full list of all side effects reported with Zevalin, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zevalin, glejte navodilo za uporabo.
The active substance in Zevalin, ibritumomab, is a monoclonal antibody.
Zdravilna učinkovina zdravila Zevalin, ibritumomab, je monoklonsko protitelo.
Before treatment with radiolabelled Zevalin, the patients must first receive an infusion of rituximab (at a dose lower than would be used for treatment) to clear B cells from their circulation, leaving the cancerous B cells in the lymph tissue.
Pred zdravljenjem z radioaktivno označenim zdravilom Zevalin morajo bolniki najprej dobiti infuzijo rituksimaba (v nižjem odmerku od tistega, ki se sicer uporablja za zdravljenje), da celice B očistijo iz obtoka in pustijo rakave celice B v limfnem tkivu.
Why has Zevalin been approved?
Zakaj je bilo zdravilo Zevalin odobreno?
The main study compared the effectiveness of Zevalin with that of rituximab in 143 patients.
V glavni študiji so pri 143 bolnikih primerjali učinkovitost zdravila Zevalin z učinkovitostjo rituksimaba.
Zevalin has also been studied in a total of 306 patients with non Hodgkin's lymphoma who were not responding to other treatments or whose disease had come back after previous treatment.
Zdravilo Zevalin so proučevali tudi pri skupno 306 bolnikih z ne-Hodgkinovim limfomom, ki se niso odzivali na druga zdravljenja ali pri katerih se je bolezen po predhodnem zdravljenju ponovila.
When Zevalin is radiolabelled, the radioactive element yttrium 90 (90Y) is attached to ibritumomab.
Ko se zdravilo Zevalin radioaktivno označi, se radioaktivni element itrij90 (90Y) veže na ibritumomab.
• patients who have gone into remission (reduction in the number of cancerous cells) after their first
• bolnikih, ki so prešli v remisijo (zmanjšanje števila rakavih celic) po prvem „indukcijskem zdravljenju“ (začetno zdravljenje s kemoterapijo) limfoma.
Radiolabelling is a technique where a substance is tagged (labelled) with a radioactive compound.
Radioaktivno označevanje je tehnika, pri kateri se učinkovina označi z radioaktivno snovjo.
This enables Zevalin to deliver radiation more specifically to the cancerous B-cells.
To zdravilu Zevalin omogoča, da se radioaktivno sevanje posebej osredotoči na rakave celice B..
‘consolidation therapy' to improve the remission; patients in whom rituximab (another treatment for non Hodgkin's lymphoma) is no longer effective or whose disease has come back after rituximab treatment.
Zdravilo Zevalin se daje kot „konsolidacijska terapija“ za izboljšanje remisije; bolnikih, pri katerih rituksimab (druga oblika zdravila za ne-Hodgkinov limfom) ni več učinkovit ali katerih bolezen se je ponovno pojavila po zdravljenju z rituksimabom.
Zevalin is radiolabelled by mixing it with a solution of radioactive yttrium (90Y) chloride.
Zdravilo Zevalin se radioaktivno označi tako, da se zmeša z raztopino radioaktivnega itrijevega (90Y) klorida.
The CHMP decided that Zevalin's benefits are greater than its risks as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma and for the treatment of adult patients with rituximab relapsed or refractory CD20-positive follicular B cell non Hodgkin's lymphoma.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Zevalin kot konsolidacijska terapija po indukciji remisije pri predhodno nezdravljenih bolnikih s folikularnim limfomom in za zdravljenje folikularnih celic B CD20+ pri odraslih bolnikih z ne-Hodgkinovim limfomom, ki se je po zdravljenju z rituksimabom ponovil ali je zanj neodziven, večje od z njim povezanih tveganj.
In an additional study, 57 patients with follicular lymphoma who had been previously treated and were not responding to rituximab received Zevalin.
V dodatni študiji je zdravilo Zevalin prejelo 57 bolnikov s folikularnim limfomom, ki so bili predhodno zdravljeni in se niso odzivali na rituksimab.
What is Zevalin used for?
Za kaj se zdravilo Zevalin uporablja?
How has Zevalin been studied?
Kako je bilo zdravilo Zevalin raziskano?
What is Zevalin?
Kaj je zdravilo Zevalin?
Zevalin is a kit for the preparation of a ‘radiolabelled' infusion (drip into a vein) of the active substance ibritumomab tiuxetan.
Zdravilo Zevalin je komplet za pripravo radioaktivno označene infuzije (kapalne infuzije v veno) zdravilne učinkovine ibritumomab tiuksetan.
How does Zevalin work?
Kako zdravilo Zevalin deluje?
When the radiolabelled medicine is injected into the patient, the monoclonal antibody carries the radioactivity to the target CD20 antigen on the B cells.
Z injiciranjem radioaktivno označenega zdravila v bolnika monoklonsko protitelo prenese radioaktivnost do ciljnega antigena CD20 v celicah B. Ko se protitelo veže na antigen, lahko začne sevanje lokalno delovati in uničevati limfom celic B.
How is Zevalin used?
Kako se zdravilo Zevalin uporablja?
• The radiolabelled medicine is used to treat adult patients with follicular B cell non Hodgkin's lymphoma.
• Radioaktivno označeno zdravilo se uporablja za zdravljenje odraslih bolnikov z ne-Hodgkinovim limfomom folikularnih celic B. To je rak limfnega tkiva (dela imunskega sistema), ki prizadene vrsto belih krvničk, imenovano limfociti B ali celice B. Zdravilo Zevalin se uporablja pri naslednjih skupinah bolnikov:
It is used to treat adults with the following conditions:
Uporablja se za zdravljenje odraslih z naslednjimi boleznimi:
This medicine is the same as Lyrica, which is already authorised in the European Union (EU).
Zdravilo je enako zdravilu Lyrica, ki je že odobreno v Evropski uniji (EU).
The medicine can only be obtained with a prescription and is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg).
Na voljo je v obliki kapsul (25, 50, 75, 100, 150, 200, 225 in 300 mg).
Neurotransmitters are chemicals that allow nerve cells to communicate with each other.
Živčni prenašalci so kemične snovi, ki omogočajo medsebojno komunikacijo živčnih celic.
Patients who have kidney problems need to take lower doses.
Bolniki, ki imajo težave z ledvicami, morajo jemati manjše odmerke.
The capsules should be swallowed whole with water.
Kapsule morajo bolniki pogoltniti cele, skupaj z vodo.
The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells.
Točno delovanje pregabalina ni popolnoma znano, vendar naj bi vplival na vstopanje kalcija v živčne celice.
The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Pfizer on 10 April 2014.
Evropska komisija je dovoljenje za promet z zdravilom Pregabalin Pfizer, veljavno po vsej Evropski uniji, izdala 10. aprila 2014.
This compared with about 10% of the patients taking placebo.
Ta delež je pri bolnikih, ki so jemali placebo, znašal okrog 10 %.
• epilepsy, where it is used as an ‘add-on' to existing treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
• epilepsijo, pri čemer se uporablja kot dodatek k obstoječemu zdravljenju pri bolnikih s parcialnimi napadi (epileptični napadi, ki izvirajo iz določenega dela možganov), ki jih ni mogoče nadzorovati s trenutnim zdravljenjem;
The full EPAR and risk management plan summary for Pregabalin Pfizer can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Pregabalin Pfizer sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The active substance in Pregabalin Pfizer, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma-amino butyric acid (GABA), but has very different biological effects.
Zdravilna učinkovina v zdravilu Pregabalin Pfizer, pregabalin, ima podobno zgradbo kot telesu lastni „živčni prenašalec“ gama-aminomaslena kislina (GABA), vendar ima bistveno drugačne biološke učinke.
This is a summary of the European public assessment report (EPAR) for Pregabalin Pfizer.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pregabalin Pfizer.
What measures are being taken to ensure the safe and effective use of Pregabalin Pfizer?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pregabalin Pfizer?
The company that makes Lyrica has agreed that its scientific data can be used for Pregabalin Pfizer (‘informed consent').
Družba, ki proizvaja zdravilo Lyrica, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Pregabalin Pfizer („uporaba dokumentacije s soglasjem“).
A risk management plan has been developed to ensure that Pregabalin Pfizer is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Pregabalin Pfizer je bil pripravljen načrt obvladovanja tveganj.
Pregabalin Pfizer is a medicine that contains the active substance pregabalin.
Pregabalin Pfizer je zdravilo, ki vsebuje zdravilno učinkovino pregabalin.
In neuropathic pain, the benefits of Pregabalin Pfizer were evaluated for up to 12 weeks using a standard pain questionnaire.
Kar zadeva nevropatske bolečine, so koristi zdravila Pregabalin Pfizer v obdobju do 12 tednov ocenjevali s standardnim vprašalnikom za točkovanje bolečine.
The most common side effects with Pregabalin Pfizer (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness).
Najpogostejša neželena učinka zdravila Pregabalin Pfizer (opažena pri več kot 1 bolniku od 10) sta omotica in zaspanost.