FrancophonIA/ELRC3.0 huggingface dataset:
English: Therapeutic plasma concentrations remain until 4 to 6 weeks after the last RISPERDAL CONSTA injection.
Slovenian: Terapevtske koncentracije se v plazmi ohranjajo še 4-6 tednov po zadnjem injiciranju zdravila RISPERDAL CONSTA.
English: • Inability to reach orgasm, ejaculation disorder, menstrual disorder
Slovenian: • nezmožnost doseganja orgazma, težave z ejakulacijo, motnje menstruacije
English: Absorption The absorption of risperidone from RISPERDAL CONSTA is complete.
Slovenian: Absorpcija Absorpcija risperidona iz zdravila RISPERDAL CONSTA je popolna.
English: It is expected that other CYP 2D6 inhibitors, such as quinidine, may affect the plasma concentrations of risperidone in a similar way.
Slovenian: Verjetno tudi ostali zaviralci CYP 2D6, kot je kinidin, na podoben način vplivajo na koncentracijo risperidona v plazmi.
English: The MAH presented a table summarising the results of total PANSS score from RIS-INT-61, broken down by dose level for the dose groups 25 mg, 50 mg and 75 mg. Two additional tables provided data showing that treatment is non-inferior to risperidone oral treatment for the changes in positive and negative symptoms subscales of PANSS.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predstavil tabelo s skupnimi rezultati PANSS iz RIS-INT-61, razdeljenimi glede na količino odmerka na skupine 25 mg, 50 mg in 75 mg. Dve dodatni tabeli sta dali podatke o tem, da zdravljenje ni manjvredno v primerjavi z zdravljenjem s peroralnim risperidonom glede sprememb pri pozitivnih in negativnih simptomih pomožne lestvice PANSS.
English: Extensive CYP 2D6 metabolisers convert risperidone rapidly into 9-hydroxy-risperidone, whereas poor CYP 2D6 metabolisers convert it much more slowly.
Slovenian: Ljudje z dobro presnovo CYP 2D6 hitro pretvorijo risperidon v 9-hidroksi-risperidon, medtem ko ga ljudje s slabo presnovo CYP 2D6 pretvorijo veliko počasneje.
English: In rat reproduction studies with risperidone, adverse effects were seen on mating behaviour of the parents, and on birth weight and survival of the offspring.
Slovenian: V študijah reprodukcije pri podganah z risperidonom so opazili neželene učinke na obnašanje med parjenjem pri starših in na porodno težo in stopnjo preživetja mladičev.
English: • involuntary rhythmic movements of the tongue, mouth and face.
Slovenian: • nehoteni ritmični gibi jezika, ust ali obraza.
English: If you experience this while taking RISPERDAL CONSTA, contact your doctor straight away
Slovenian: Če se vam to zgodi med jemanjem zdravila RISPERDAL CONSTA, se o tem takoj posvetujte z zdravnikom.
English: High-Wycombe Buckinghamshire HP 14 4HJ United Kingdom
Slovenian: High-Wycombe Buckinghamshire HP 14 4HJ Zdruzeno kraljestvo
English: There are no data suggesting kidney-related changes in dogs treated chronically with RISPERDAL CONSTA.
Slovenian: Ni podatkov, ki bi nakazovali spremembe na ledvicah pri psih, ki so kronično prejemali RISPERDAL CONSTA.
English: WHAT RISPERDAL CONSTA IS AND WHAT IT IS USED FOR RISPERDAL CONSTA belongs to a group of medicines called ‘anti-psychotics'.
Slovenian: KAJ JE ZDRAVILO RISPERDAL CONSTA IN ZA KAJ GA UPORABLJAMO Zdravilo RISPERDAL CONSTA uvrščamo v skupino zdravil imenovano antipsihotiki.
English: DATE OF REVISION OF THE TEXT [To be completed nationally]
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA [Poglavje bo dopolnjeno nacionalno]
English: • A lower dose of 12.5 mg or a higher dose of 37.5 or 50 mg may also be necessary.
Slovenian: • Včasih je lahko potreben nižji odmerek, 12,5 mg, ali višji odmerek, 37,5 mg ali 50 mg.
English: • One vial containing RISPERDAL CONSTA extended release microspheres
Slovenian: • Ena viala, ki vsebuje RISPERDAL CONSTA v obliki mikrosfer s podaljšanim sproščanjem.
English: In case of acute overdose, the possibility of multiple drug involvement should be considered.
Slovenian: V primeru akutnega prekomernega odmerka, je treba proučiti, ali je morda posledica sočasnega jemanja več zdravil.
English: Additional signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Slovenian: Dodatni znaki vključujejo mioglobinurijo (rabdomioliza) in akutno ledvično odpoved.
English: • Lack of emotion, confusion, poor attention, loss of consciousness, balance disorder
Slovenian: • motnje čustvovanja, zmedenost, motnje pozornosti, izguba zavesti, motnje ravnotežja
English: However, the CHMP requested the MAH to further discuss the proposed wording of the indication, and the need to establish tolerability with oral risperidone prior to initiating treatment with Risperdal Consta.
Slovenian: Kljub temu je CHMP imetnika dovoljenja za promet z zdravilom zaprosil, da podrobneje preuči predlagano besedilo za to indikacijo ter potrebo po vzpostavitvi tolerabilnosti do zdravljenja z oralnim pripravkom risperidona pred pričetkom zdravljenja z zdravilom Risperdal Consta.
English: Janssen-Cilag Pharma GmbH Pfarrgasse 75, 1232 Wien, Austria
Slovenian: Janssen-Cilag Pharma GmbH Pfarrgasse 75, 1232 Dunaj, Avstrija
English: The CHMP agreed that the presence of cerebrovascular risk factors is poorly predictive for a risperidone-mediated increased cerebrovascular risk and was therefore of the opinion that a contraindication for Risperdal Consta in patients with high risk factors for cerebrovascular events was not justified.
Slovenian: CHMP se strinja, da je prisotnost dejavnikov cerebrovaskularnega tveganja težko predvidljiva za povečano cerebrovaskularno tveganje nastalo zaradi uporabe risperidona in menil, da kontraindikacija zdravila Risperdal Consta pri bolnikih z visokimi faktorji tveganja za cerebrovaskularne dogodke, ni utemeljena.
English: All sections of the SPC were thoroughly assessed and all revisions were implemented accordingly in the Labelling and in the Package Leaflet, achieving a harmonised Product Information text.
Slovenian: Vsa poglavja povzetka glavnih značilnosti zdravila so bila temeljito preučena in vse spremembe so bile vključene tudi v označevanje in navodila za uporabo, s čimer so besedila informacij o zdravilu usklajena.
English: All differences were accordingly justified and the proposed wording in the SPC is acceptable.
Slovenian: Vsa razhajanja so bila ustrezno utemeljena, predlagano besedilo za povzetek glavnih značilnosti zdravilo pa je sprejemljivo.
English: The CHMP predominantly agreed to the proposed grouping of terms of adverse events, but nevertheless considered that “bundle branch block left” should not be separated from “bundle block right” as the different clinical management is not essential.
Slovenian: V glavnem se je strinjal s predlaganimi skupinami neželenih učinkov in menil, da levo kračnega bloka ni treba ločiti od desno kračnega bloka, saj ne zahtevata različnega kliničnega vodenja.
English: Diabetic ketoacidosis
Slovenian: Zelo redki diabetična ketoacidoza
English: A population pharmacokinetic analysis revealed no apparent effect of gender, race or smoking habits on the pharmacokinetics of risperidone or the active antipsychotic fraction.
Slovenian: Analiza populacijske farmakokinetike ni pokazala vplivov spola, rase ali kajenja na farmakokinetiko risperidona ali aktivne antipsihotične frakcije.
English: • Abnormal electrical conduction of the heart, high blood pressure, fast beating heart, chest pain,
Slovenian: • nenormalna električna prevodnost v srcu, povišan krvni tlak, pospešeno bitje srca, bolečine v prsih,
English: Risperidone plasma concentrations were normal in patients with liver insufficiency, but the mean free fraction of risperidone in plasma was increased by about 35%.
Slovenian: Pri bolnikih z motnjami v delovanje jeter so bile plazemske koncentracije normalne, povprečna prosta frakcija risperidona v plazmi pa je bila povišana za približno 35 %.
English: Do not drive or use any tools or machines without talking to your doctor first.
Slovenian: Preden začnete voziti, upravljati orodja ali stroje se posvetujte z zdravnikom.
English: Regarding the precise correspondence of an oral risperidone dose to a specific dose of Risperdal Consta, a wording in the SPC was adopted, reflecting the available efficacy and safety data and the results of clinical studies, to guide the choice of starting dose of Risperdal Consta:
Slovenian: Upoštevajoč visoko skladnost odmerka peroralnega risperidona s specifičnim odmerkom zdravila Risperdal Consta je bila za povzetek glavnih značilnosti zdravila potrjena ubeseditev, ki odraža razpoložljive podatke o učinkovitosti in varnosti ter rezultate kliničnih študij kot vodilo pri določitvi začetnega odmerka zdravila Risperdal Consta:
English: As with other antipsychotics, very rare cases of QT prolongation have been reported postmarketing with risperidone.
Slovenian: Kot pri ostalih antipsihotikih so med postmarketinško uporabo risperidona zelo redko poročali o primerih podaljšanja QT intervala.
English: Risperidone has no affinity for cholinergic receptors.
Slovenian: Risperidon nima afinitete za holinergične receptorje.
English: • Blood prolactin hormone level increased, liver enzymes increased, decrease in hemoglobin or red blood cell count (anemia), blood sugar increased
Slovenian: • povišan hormon prolaktin v krvi, povišani jetrni encimi, znižan hemoglobin ali število rdečih krvnih celic (anemija), povišan krvni sladkor
English: • You have difficulty controlling body temperature or overheating
Slovenian: • če imate težave z vzdrževanjem telesne temperature oz. se hitro pregrejete
English: Remove the dose pack of RISPERDAL CONSTA from the refrigerator and allow it to come to room temperature prior to reconstitution.
Slovenian: Škatlico z zdravilom RISPERDAL CONSTA vzamemo iz hladilnika in pustimo, da zdravilo pred pripravo doseže sobno temperaturo.
English: Risperidone is metabolised by CYP 2D6 to 9-hydroxy-risperidone, which has a similar pharmacological activity as risperidone.
Slovenian: Citokrom CYP 2D6 presnovi risperidon v 9-hidroksi-risperidon, ki ima podobno farmakološko delovanje kot risperidon.
English: No dose adjustment is required.
Slovenian: Odmerkov ni treba prilagajati.
English: Pharmacokinetic/pharmacodynamic relationship
Slovenian: Povezava med farmakokinetiko in farmakodinamiko
English: Nevertheless, caution should be exercised and the risks and benefits of this combination or co-treatment with other potent diuretics should be considered prior to the decision to use.
Slovenian: Kljub temu je pred odoločitvijo za sočasno uporabo te kombinacije ali sočasnem zdravljenju z drugimi močnimi diuretiki potrebno pretehtati koristi in tveganje zdravljenja.
English: Hypercalcemia, postulated to contribute to an increased incidence of adrenal medullary tumours in RISPERDAL CONSTA-treated rats, was observed in both dose groups.
Slovenian: Hiperkalciemija, ki pripomore k povečani pojavnosti adrenalnega medularnega tumorja pri podganah po zdravljenju z zdravilom RISPERDAL CONSTA, se je pojavila v obeh skupinah.
English: Similar to the (sub)chronic toxicity studies with oral risperidone in rats and dogs, the major effects of treatment with RISPERDAL CONSTA (up to 12 months of intramuscular administration) were prolactin-mediated mammary gland stimulation, male and female genital tract changes, and central nervous system (CNS) effects, related to the pharmacodynamic activity of risperidone.
Slovenian: Podobno kot v študijah (sub)kronične toksičnosti s peroralnim risperidonom na podganah in psih, so bili glavni učinki zdravljenja z zdravilom RISPERDAL CONSTA (do 12 mesecev intramuskularne uporabe), s prolaktinom povzročena stimulacija mlečne žleze, spremembe samčevih in samičjih spolovil ter učinki na osrednji živčni sistem (CŽS), ki so povezani s farmakodinamično aktivnostjo risperidona.
English: No additional benefit was observed with 75 mg in clinical trials.
Slovenian: V kliničnih preskušanjih niso opazili nobenega dodatnega učinka pri uporabi 75 mg odmerka.
English: The long-term (50 weeks) safety and efficacy of RISPERDAL CONSTA was also evaluated in an open-label trial of stable psychotic inpatients and outpatients who met the DSM-IV criteria for schizophrenia or schizoaffective disorder.
Slovenian: Dolgotrajno varnost in učinkovitost (50 tednov) zdravila RISPERDAL CONSTA so ugotavljali v odprtem preskušanju, v katerem so sodelovali stabilni hospitalizirani in ambulantni bolniki s psihozo, ki so ustrezali kriterijem DSM-IV za shizofrenijo oz. shizoafektivne motnje.
English: Tell your doctor immediately if you experience
Slovenian: Takoj obvestite zdravnika če se pri vas pojavi:
English: • People who have been given more RISPERDAL CONSTA than they should have experienced the following symptoms: sleepiness, tiredness, abnormal body movements, problems with standing and walking, dizziness from low blood pressure, and abnormal heart beats.
Slovenian: • Ljudje, ki so prejeli večji odmerek zdravila RISPERDAL CONSTA, kot bi ga smeli, so imeli naslednje simptome: zaspanost, utrujenost, nenormalne telesne gibe, težave pri stanju in hoji, vrtoglavico zaradi nizkega krvnega tlaka in nenormalno bitje srca.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally]
Slovenian: 6.2 Inkompatibilnosti [Poglavje bo dopolnjeno nacionalno] 6.3 Rok uporabnosti [Poglavje bo dopolnjeno nacionalno] 6.4 Posebna navodila za shranjevanje [Poglavje bo dopolnjeno nacionalno] 6.5 Vrsta ovojnine in vsebina [Poglavje bo dopolnjeno nacionalno]
English: The effect dose for osteodystrophy in rats was on a mg/m2 basis 8 times the maximum recommended human dose and is associated with a plasma exposure 2 times the maximum anticipated exposure in humans at the maximum recommended dose.
Slovenian: 2, 8-krat višji od največjega priporočenega odmerka pri ljudeh osteodistrofija, je bil preračunano na mg/m in je bil povezan z 2-krat višjo plazemsko izpostavljenostjo, ki je pričakovana pri najvišjem priporočenem odmerku.
English: Risperdal Consta (risperidone) is a benzisoxazole derivative with potent combined serotonin 5HT2A and dopamine D2 receptor-blocking properties.
Slovenian: Zdravilo Risperdal Consta (risperidon) je derivat benzisoksazola z močnimi združenimi zaviralnimi lastnostmi serotonina 5HT2A in receptorjev dopamina D2.
English: Contents of the dose pack:
Slovenian: Vsebina škatlice:
English: The pharmacokinetics of risperidone are also linear in the dose range of 25-50 mg injected every 2 weeks.
Slovenian: Farmakokinetika risperidona je linearna tudi pri obmerkih 25-50 mg, injiciranih vsaka 2 tedna.
English: In the oral RISPERDAL placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone (7.3%; mean age 89 years, range 75-97) when compared to patients treated with risperidone alone (3.1%; mean age 84 years, range 70-96) or furosemide alone (4.1%; mean age 80 years, range 67-90).
Slovenian: V kliničnih preskušanjih nadzorovanih s placebom pri starejših bolnikih z demenco, so ugotovili povečano pojavnost smrtnosti pri bolnikih, ki so sočasno jemali furosemid in risperidon (7,3 %, povprečna starost 89 let, območje 75-97 let) v primerjavi z bolniki, ki so jemali samo risperidon (3,1 %, povprečna starost 84 let, območje 70-96 let) ali samo furosemid (4,1 %, povprečna starost 80 let, interval 67-90 let).
English: • fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome).
Slovenian: • povišana telesna temperatura, okorelost mišic, potenje ali nezavest (stanje, ki se imenuje nevroleptični maligni sindrom).
English: 6.6 Special precautions for disposal and other handling Instructions for Three Needle System
Slovenian: 6.6 Navodila za uporabo/rokovanje in uničenje Navodila za uporabo pakiranja s tremi iglami
English: In placebo-controlled trials with oral RISPERDAL in this population, the incidence of mortality was 4.0% for RISPERDAL-treated patients compared to 3.1% for placebotreated patients.
Slovenian: V kliničnih preskušanjih nadzorovanih s placebom, je bila smrtnost pri tej populaciji 4,0 % pri bolnikih zdravljenih s peroralno obliko zdravila Risperdal v primerjavi s 3,1 % v skupini, ki je prejemala placebo.
English: - the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling and package leaflet,
Slovenian: - da je bil obseg napotitve uskladitev povzetkov glavnih značilnosti zdravil, označevanja in navodil za uporabo,
English: Due to the alpha-blocking activity of risperidone, (orthostatic) hypotension can occur, especially during initiation of treatment.
Slovenian: Zaradi zaviralnega delovanja risperidona na alfa receptorje se lahko pojavi ortostatska hipotenzija, še zlasti na začetku zdravljenja.
English: Local irritation at the injection site in dogs and rats was observed after administration of high doses of RISPERDAL CONSTA.
Slovenian: Lokalno draženje na mestu injiciranja pri psih in podganah so proučevali po injiciranju visokih odmerkov zdravila RISPERDAL CONSTA.
English: Cystitis, Gastroenteritis, Infection, Localised infection, Subcutaneous abscess
Slovenian: Občasni cistitis, gastroenteritis, okužbe, lokalizirane infekcije, podkožni absces
English: • Eosinophil (special white blood cells ) count increased, blood creatine phosphokinase increased
Slovenian: • povečano število eozinofolcev (posebne bele krvne celice), zvišana koncentracija kreatin fosfokinaze v krvi
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial for powder for suspension for injection (all packs)
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH Viala za prašek za suspenzijo za injiciranje (vsa pakiranja)
English: RISPERDAL CONSTA should be administered with caution in this group of patients (see section 4.2).
Slovenian: Pri tej skupini bolnikov je potrebno zdravilo RISPERDAL CONSTA uporabljati previdno (glejte poglavje 4.2).
English: Phenothiazines, tricyclic antidepressants, and some beta-blockers may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction.
Slovenian: Fenotiazini, triciklični antidepresivi in nekateri beta-blokatorji lahko zvišajo plazemsko koncentracijo risperidona, ne pa koncentracije aktivne antipsihotične frakcije.
English: If you are given more RISPERDAL CONSTA than you should
Slovenian: Če ste prejeli večji odmerek zdravila RISPERDAL CONSTA kot bi ga smeli
English: Adverse Drug Reactions by System Organ Class and Frequency Category Investigations
Slovenian: Neželeni učinki glede na organski sistem in pogostnost Preiskave
English: The most frequently reported adverse drug reactions (ADRs) (incidence ≥ 1/10) are: Insomnia, anxiety, headache, upper respiratory tract infection, parkinsonism, depression, and akathisia.
Slovenian: Najpogosteje poročani neželeni učinki (pogostnost ≥1/10) so bili: nespečnost, tesnoba, glavobol, okužbe zgornjih dihal, parkinsonizem, depresija in akatizija.
English: In the 12-week double-blind, placebo-controlled trial, 9% of patients treated with RISPERDAL CONSTA, compared with 6% of patients treated with placebo, experienced a weight gain of ≥ 7% of body weight at endpoint.
Slovenian: V 12-tedenskem, dvojno-slepem, s placebom nadzorovanem preskušanju se je telesna masa 9 % bolnikom, ki so bili zdravljeni z zdravilom RISPERDAL CONSTA in 6 % bolnikom, ki so prejemali placebo ob koncu preskušanja povečala za ≥ 7 %.
English: Carbamazepine has been shown to decrease the plasma concentrations of the active antipsychotic fraction of risperidone.
Slovenian: Ugotovili so, da karbamazepin znižuje plazemske koncentracije aktivne antipsihotične frakcije risperidona.
English: Based on the submitted data, the CHMP was of the opinion that the presented clinical data show that patients stabilised with any antipsychotic medication (oral or depot formulations) can safely be switched to Risperdal Consta and achieve a clinical benefit similar to that seen in patients being switched from oral risperidone and without a higher incidence of clinical deterioration.
Slovenian: Na podlagi predloženih podatkov je CHMP menil, da predstavljeni klinični podatki pri bolnikih stabiliziranih s kakšnim drugimi antipsihotičnimi zdravili (peroralnimi ali depotnimi pripravki) kažejo, da se ti bolniki lahko varno pričnejo zdraviti z zdravilom Risperdal Consta ter dosežejo klinično korist podobno tisti, doseženi pri bolnikih, ki so prešli z zdravljenja s peroralnim risperidonom in brez večje pojavnosti kliničnega poslabšanja.
English: Holding the plunger rod down with the thumb, shake the vial vigorously for at least 10 seconds until obtaining a homogeneous suspension.
Slovenian: Bat injekcijske brizge držimo s palcem navzdol in pri tem vialo močno stresamo vsaj 10 sekund, dokler ne dobimo homogene suspenzije
English: • Unresponsive to stimuli, stroke, decreased blood supply to the brain, brain blood vessel disorder, sudden weakness or numbness of the face, arms, or legs, especially on one side, or instances of slurred speech that last for less than 24 hours (these are called mini-strokes or strokes)
Slovenian: • neodzivnost na dražljaje, možganska kap, zmanjšana prekrvavitev možganov, okvare krvnih žil v možganih, nenadna slabotnost ali otrplost obraza, rok ali nog, posebej na eni strani telesa ali primeri nerazločnega govorjenja, ki traja manj kot 24 ur (to so t.i. blage možganske kapi ali možganske kapi)
English: Doses higher than 50 mg every 2 weeks are not recommended.
Slovenian: Ni priporočljivo uporabljati odmerkov višjih od 50 mg vsaka dva tedna.
English: Johnson & Johnson D.O.O.
Slovenian: Bulgarija Johnson & Johnson D.O.O.
English: After procedure is completed, press the needle into the needle protection device.
Slovenian: Po zaključenem postopku iglo potisnemo v pripomoček za zaščito.
English: Your doctor will choose RISPERDAL CONSTA 25 mg or 37.5 mg.
Slovenian: Vaš zdravnik se bo odločil za zdravilo RISPERDAL CONSTA v odmerku 25 mg ali 37,5 mg.
English: Injury, poisoning and procedural complications Common
Slovenian: Poškodbe in zastrupitve Pogosti padci
English: QT prolongation has very rarely been reported postmarketing.
Slovenian: Podaljšanje QT intervala je bilo zelo redko poročano v obdobju po prihodu zdravila na trg.
English: If hepatically or renally impaired patients require treatment with RISPERDAL CONSTA, a starting dose of 0.5 mg twice daily oral risperidone is recommended during the first week.
Slovenian: V primeru, da je bolnike z ledvično ali jetrno okvaro treba zdraviti z zdravilom Risperdal Consta, je priporočljivo, da v prvem tednu sprva dvakrat dnevno jemljejo 0,5 mg risperidona v peroralni obliki.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Slovenian: Morebitne odpadke zavrzite v skladu z lokalnimi predpisi.
English: The main release of risperidone starts from Week 3 onwards, is maintained from 4 to 6 weeks, and subsides by Week 7.
Slovenian: Po intramuskularnem injiciranju se glavno sproščanje zdravila začne šele po treh tednih, traja 4-6 tednov, s sedmim tednom pa upade.
English: • Medicines that cause a slow heart beat
Slovenian: • zdravila, ki upočasnijo srčno frekvenco
English: Thrombocytopenia, Neutropenia
Slovenian: Občasni trombocitopenija, nevtropenija
English: • Fainting, drop in blood pressure after standing, feeling dizzy after changing body position
Slovenian: • omedlevica, padec krvnega tlaka ob vstajanju, občutek omotičnosti ob spremembi položaja