natgillin/translations-raw huggingface dataset:
In urine, risperidone plus 9-hydroxy-risperidone represent 35-45% of the orally administered dose. 
Risperidon in 9-hidroksi-risperidon predstavljata 35-45 % peroralnega odmerka v urinu.
Elderly people with dementia RISPERDAL CONSTA is not for use in elderly people with dementia. 
Starejši ljudje z demenco Zdravilo RISPERDAL CONSTA ni namenjeno za uporabo pri starejših ljudeh z demenco.
Agitation, Sleep disorder 
Pogosti agitacija, motnje spanja
• Sexual dysfunction, enlargement of breast in men, decreased sexual drive 
• spolna disfunkcija, povečanje prsi pri moških, zmanjšan libido
In a 12-week comparative trial in stable patients with schizophrenia, RISPERDAL CONSTA was shown to be as effective as the oral tablet formulation. 
12-tedensko primerjalno preskušanje, v katerem so sodelovali stabilni bolniki s shizofrenijo, pa je pokazalo, da je zdravilo RISPERDAL CONSTA enako učinkovito kot peroralne tablete.
Relatively constant dose-response after Risperdal Consta treatment using doses from 25 to 75 mg is considered to be established and the CHMP agreed that good medical practice would be to start patients at the lowest effective dose and to increase the dose only if the response is insufficient. 
Relativno konstanten odziv na odmerek zdravila Risperdal Consta po uporabi odmerkov od 25 mg do 75 mg je potrjen, in CHMP se je strinjal, da dobra medicinska praksa pomeni pričetek zdravljenja bolnikov z najmanjšim učinkovitim odmerkom ter da se ta odmerek povečuje le v primeru, kadar odziv nanj ni zadosten.
Elderly, hepatic and renal impairment 
Starejši, jetrna in ledvična okvara
According to various treatment guidelines of schizophrenia, the switch of antipsychotic treatment in patients with schizophrenia requires “per se” the increased monitoring of therapy by qualified physicians and the CHMP was therefore of the opinion that due to nature of the illness and long-term experience with treatment of schizophrenia by atypical antipsychotics, proper monitoring of therapy after switching antipsychotic treatment can be expected, without being explicitly mentioned in the SPC. 
Upoštevajoč različne smernice zdravljenja shizofrenije, sprememba antipsihotičnega zdravljenja pri bolnikih s shizofrenijo sama po sebi zahteva povečano nadzorovanje terapije z ustrezno usposobljenimi zdravniki in tako je CHMP menil, da je zaradi vrste bolezni in dolgoročnih izkušenj pri zdravljenju shizofrenije z atipičnimi antipsihotiki, ustrezno nadzorovanje terapije po spremembi antipsihotičnega zdravljenja shizofrenije, pričakovano, in da ni potrebe po posebni navedbi v povzetku glavnih značilnosti zdravila.
After repeated intramuscular injections with 25 or 50 mg RISPERDAL CONSTA every two weeks, median trough and peak plasma concentrations of the active antipsychotic fraction fluctuated between 9.9-19.2 ng/ml and 17.9-45.5 ng/ml respectively. 
Po večkratnih intramuskularnih injiciranjih 25 ali 50 mg zdravila RISPERDAL CONSTA vsaka dva tedna, so srednje najnižje koncentracije aktivne antipsihotične frakcije v plazmi nihale med 9,9 in 19,2 ng/ml, najvišje pa med 17,9-45,5 ng/ml.
Medicines with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical involuntary movements, predominantly of the tongue and/or face. 
Zdravila z antagonističnim delovanjem na dopaminske receptorje so povezali z nastankom tardivne diskinezije, za katero so značilni nehoteni ritmični gibi, predvsem jezika in/ali obraza.
Be sure not to miss your appointments when you are supposed to receive your injections every two weeks. 
Ne zamudite obiska pri zdravniku vsaka dva tedna, kadar ste naročeni za injiciranje zdravila.
The CHMP adopted the following text in section 4.2: 
Odbor za zdravila za uporabo v humani medicini je tako sprejel naslednje besedilo za poglavje 4.2:
Risperidone binds also to alpha1-adrenergic receptors, and, with lower affinity, to H1-histaminergic and alpha2-adrenergic receptors. 
Risperidon se prav tako veže na α1adrenergične receptorje in z manjšo afiniteto na histaminske H1 in α 2-adrenergične receptorje.
The following side effects may happen: Very common side effects (affects more than 1 user in 10): 
Lahko se pojavijo naslednji neželeni učinki: Zelo pogosti neželeni učinki (pojavijo se pri več kot 1 uporabniku na vsakih 10):
The following medicines may reduce the effect of risperidone 
Naslednja zdravila lahko zmanjšajo učinek risperidona:
The plasma protein binding of risperidone is 90%; that of the active metabolite 9-hydroxy-risperidone is 77%. 
Na plazemske beljakovine se veže 90 % risperidona in 77 % 9-hidroksi-risperidona.
Children and adolescents RISPERDAL CONSTA is not for people who are under 18 years old. 
Otroci in mladostniki Zdravilo RISPERDAL CONSTA ni namenjeno za uporabo pri ljudeh mlajših od 18 let.
• Medicines known as beta blockers (used to treat high blood pressure) 
• zaviralci adrenergičnih receptorjev beta (zdravila, ki se uporabljajo za zdravljenje visokega krvnega tlaka)
In addition, long-acting risperidone offers an advantage in increased compliance to the treatment, which could result in more stable plasma levels of risperidone. 
Poleg tega dolgo delujoč risperidon ponuja prednost povečane usklajenosti zdravljenja, ki se posledično lahko odraža v bolj stabilnih ravneh koncentracije risperidona v plazmi.
The length of the oral supplementation period was also discussed and the CHMP concluded that 3 weeks is the most appropriate length, leading neither to an overdose at the end of the oral supplementation period in those patients who have a relatively early release, nor to clinically relevant ‘underdosing' in patients for whom the main release starts from 4 weeks onwards only, given the relatively long half-life of the active moiety following oral risperidone. 
Razprava je potekala tudi o dolžini trajanja dodajanja peroralnega zdravila, pri čemer je CHMP menil, da je najprimernejše tritedensko obdobje dodajanja, kar ne povzroča niti prevelikega odmerjanja ob koncu dodajanja peroralnega zdravila pri bolnikih, pri katerih sproščanje zdravila poteka hitro, niti klinično pomembnega „premajhnega odmerjanja“ pri bolnikih, pri katerih se glavni del sproščanja prične šele po štirih tednih, upoštevajoč relativno dolgo razpolovno dobo aktivne snovi po peroralnem risperidonu.
Therapeutic plasma concentrations remain until 4 to 6 weeks after the last RISPERDAL CONSTA injection. 
Terapevtske koncentracije se v plazmi ohranjajo še 4-6 tednov po zadnjem injiciranju zdravila RISPERDAL CONSTA.
• Inability to reach orgasm, ejaculation disorder, menstrual disorder 
• nezmožnost doseganja orgazma, težave z ejakulacijo, motnje menstruacije
Absorption The absorption of risperidone from RISPERDAL CONSTA is complete. 
Absorpcija Absorpcija risperidona iz zdravila RISPERDAL CONSTA je popolna.
It is expected that other CYP 2D6 inhibitors, such as quinidine, may affect the plasma concentrations of risperidone in a similar way. 
Verjetno tudi ostali zaviralci CYP 2D6, kot je kinidin, na podoben način vplivajo na koncentracijo risperidona v plazmi.
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. 
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.
Extensive CYP 2D6 metabolisers convert risperidone rapidly into 9-hydroxy-risperidone, whereas poor CYP 2D6 metabolisers convert it much more slowly. 
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.
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. 
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.
• involuntary rhythmic movements of the tongue, mouth and face. 
• nehoteni ritmični gibi jezika, ust ali obraza.
If you experience this while taking RISPERDAL CONSTA, contact your doctor straight away 
Če se vam to zgodi med jemanjem zdravila RISPERDAL CONSTA, se o tem takoj posvetujte z zdravnikom.
High-Wycombe Buckinghamshire HP 14 4HJ United Kingdom 
High-Wycombe Buckinghamshire HP 14 4HJ Zdruzeno kraljestvo
There are no data suggesting kidney-related changes in dogs treated chronically with RISPERDAL CONSTA. 
Ni podatkov, ki bi nakazovali spremembe na ledvicah pri psih, ki so kronično prejemali RISPERDAL CONSTA.
WHAT RISPERDAL CONSTA IS AND WHAT IT IS USED FOR RISPERDAL CONSTA belongs to a group of medicines called ‘anti-psychotics'. 
KAJ JE ZDRAVILO RISPERDAL CONSTA IN ZA KAJ GA UPORABLJAMO Zdravilo RISPERDAL CONSTA uvrščamo v skupino zdravil imenovano antipsihotiki.
DATE OF REVISION OF THE TEXT [To be completed nationally] 
DATUM ZADNJE REVIZIJE BESEDILA [Poglavje bo dopolnjeno nacionalno]
• A lower dose of 12.5 mg or a higher dose of 37.5 or 50 mg may also be necessary. 
• Včasih je lahko potreben nižji odmerek, 12,5 mg, ali višji odmerek, 37,5 mg ali 50 mg.
• One vial containing RISPERDAL CONSTA extended release microspheres 
• Ena viala, ki vsebuje RISPERDAL CONSTA v obliki mikrosfer s podaljšanim sproščanjem.
In case of acute overdose, the possibility of multiple drug involvement should be considered. 
V primeru akutnega prekomernega odmerka, je treba proučiti, ali je morda posledica sočasnega jemanja več zdravil.
Additional signs may include myoglobinuria (rhabdomyolysis) and acute renal failure. 
Dodatni znaki vključujejo mioglobinurijo (rabdomioliza) in akutno ledvično odpoved.
• Lack of emotion, confusion, poor attention, loss of consciousness, balance disorder 
• motnje čustvovanja, zmedenost, motnje pozornosti, izguba zavesti, motnje ravnotežja
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. 
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.
Janssen-Cilag Pharma GmbH Pfarrgasse 75, 1232 Wien, Austria 
Janssen-Cilag Pharma GmbH Pfarrgasse 75, 1232 Dunaj, Avstrija
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. 
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.
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. 
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.
All differences were accordingly justified and the proposed wording in the SPC is acceptable. 
Vsa razhajanja so bila ustrezno utemeljena, predlagano besedilo za povzetek glavnih značilnosti zdravilo pa je sprejemljivo.
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. 
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.
Diabetic ketoacidosis 
Zelo redki diabetična ketoacidoza
A population pharmacokinetic analysis revealed no apparent effect of gender, race or smoking habits on the pharmacokinetics of risperidone or the active antipsychotic fraction. 
Analiza populacijske farmakokinetike ni pokazala vplivov spola, rase ali kajenja na farmakokinetiko risperidona ali aktivne antipsihotične frakcije.
• Abnormal electrical conduction of the heart, high blood pressure, fast beating heart, chest pain, 
• nenormalna električna prevodnost v srcu, povišan krvni tlak, pospešeno bitje srca, bolečine v prsih,
Risperidone plasma concentrations were normal in patients with liver insufficiency, but the mean free fraction of risperidone in plasma was increased by about 35%. 
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 %.
Do not drive or use any tools or machines without talking to your doctor first. 
Preden začnete voziti, upravljati orodja ali stroje se posvetujte z zdravnikom.
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: 
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:
As with other antipsychotics, very rare cases of QT prolongation have been reported postmarketing with risperidone. 
Kot pri ostalih antipsihotikih so med postmarketinško uporabo risperidona zelo redko poročali o primerih podaljšanja QT intervala.
Risperidone has no affinity for cholinergic receptors. 
Risperidon nima afinitete za holinergične receptorje.
• Blood prolactin hormone level increased, liver enzymes increased, decrease in hemoglobin or red blood cell count (anemia), blood sugar increased 
• povišan hormon prolaktin v krvi, povišani jetrni encimi, znižan hemoglobin ali število rdečih krvnih celic (anemija), povišan krvni sladkor
• You have difficulty controlling body temperature or overheating 
• če imate težave z vzdrževanjem telesne temperature oz. se hitro pregrejete
Remove the dose pack of RISPERDAL CONSTA from the refrigerator and allow it to come to room temperature prior to reconstitution. 
Škatlico z zdravilom RISPERDAL CONSTA vzamemo iz hladilnika in pustimo, da zdravilo pred pripravo doseže sobno temperaturo.
Risperidone is metabolised by CYP 2D6 to 9-hydroxy-risperidone, which has a similar pharmacological activity as risperidone. 
Citokrom CYP 2D6 presnovi risperidon v 9-hidroksi-risperidon, ki ima podobno farmakološko delovanje kot risperidon.
No dose adjustment is required. 
Odmerkov ni treba prilagajati.
Pharmacokinetic/pharmacodynamic relationship 
Povezava med farmakokinetiko in farmakodinamiko
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. 
Kljub temu je pred odoločitvijo za sočasno uporabo te kombinacije ali sočasnem zdravljenju z drugimi močnimi diuretiki potrebno pretehtati koristi in tveganje zdravljenja.
Hypercalcemia, postulated to contribute to an increased incidence of adrenal medullary tumours in RISPERDAL CONSTA-treated rats, was observed in both dose groups. 
Hiperkalciemija, ki pripomore k povečani pojavnosti adrenalnega medularnega tumorja pri podganah po zdravljenju z zdravilom RISPERDAL CONSTA, se je pojavila v obeh skupinah.
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. 
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.
No additional benefit was observed with 75 mg in clinical trials. 
V kliničnih preskušanjih niso opazili nobenega dodatnega učinka pri uporabi 75 mg odmerka.
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. 
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.
Tell your doctor immediately if you experience 
Takoj obvestite zdravnika če se pri vas pojavi:
• 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. 
• 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.
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] 
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]
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. 
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.
Risperdal Consta (risperidone) is a benzisoxazole derivative with potent combined serotonin 5HT2A and dopamine D2 receptor-blocking properties. 
Zdravilo Risperdal Consta (risperidon) je derivat benzisoksazola z močnimi združenimi zaviralnimi lastnostmi serotonina 5HT2A in receptorjev dopamina D2.
Contents of the dose pack: 
Vsebina škatlice:
The pharmacokinetics of risperidone are also linear in the dose range of 25-50 mg injected every 2 weeks. 
Farmakokinetika risperidona je linearna tudi pri obmerkih 25-50 mg, injiciranih vsaka 2 tedna.
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). 
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).
• fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome). 
• povišana telesna temperatura, okorelost mišic, potenje ali nezavest (stanje, ki se imenuje nevroleptični maligni sindrom).
6.6 Special precautions for disposal and other handling Instructions for Three Needle System 
6.6 Navodila za uporabo/rokovanje in uničenje Navodila za uporabo pakiranja s tremi iglami
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. 
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.
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling and package leaflet, 
- da je bil obseg napotitve uskladitev povzetkov glavnih značilnosti zdravil, označevanja in navodil za uporabo,
Due to the alpha-blocking activity of risperidone, (orthostatic) hypotension can occur, especially during initiation of treatment. 
Zaradi zaviralnega delovanja risperidona na alfa receptorje se lahko pojavi ortostatska hipotenzija, še zlasti na začetku zdravljenja.
Local irritation at the injection site in dogs and rats was observed after administration of high doses of RISPERDAL CONSTA. 
Lokalno draženje na mestu injiciranja pri psih in podganah so proučevali po injiciranju visokih odmerkov zdravila RISPERDAL CONSTA.
Cystitis, Gastroenteritis, Infection, Localised infection, Subcutaneous abscess 
Občasni cistitis, gastroenteritis, okužbe, lokalizirane infekcije, podkožni absces
• Eosinophil (special white blood cells ) count increased, blood creatine phosphokinase increased 
• povečano število eozinofolcev (posebne bele krvne celice), zvišana koncentracija kreatin fosfokinaze v krvi
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial for powder for suspension for injection (all packs) 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH Viala za prašek za suspenzijo za injiciranje (vsa pakiranja)
RISPERDAL CONSTA should be administered with caution in this group of patients (see section 4.2). 
Pri tej skupini bolnikov je potrebno zdravilo RISPERDAL CONSTA uporabljati previdno (glejte poglavje 4.2).
Phenothiazines, tricyclic antidepressants, and some beta-blockers may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction. 
Fenotiazini, triciklični antidepresivi in nekateri beta-blokatorji lahko zvišajo plazemsko koncentracijo risperidona, ne pa koncentracije aktivne antipsihotične frakcije.
If you are given more RISPERDAL CONSTA than you should 
Če ste prejeli večji odmerek zdravila RISPERDAL CONSTA kot bi ga smeli
Adverse Drug Reactions by System Organ Class and Frequency Category Investigations 
Neželeni učinki glede na organski sistem in pogostnost Preiskave
The most frequently reported adverse drug reactions (ADRs) (incidence ≥ 1/10) are: Insomnia, anxiety, headache, upper respiratory tract infection, parkinsonism, depression, and akathisia. 
Najpogosteje poročani neželeni učinki (pogostnost ≥1/10) so bili: nespečnost, tesnoba, glavobol, okužbe zgornjih dihal, parkinsonizem, depresija in akatizija.