natgillin/translations-raw huggingface dataset:
Hypersensitivity Drug hypersensitivity Anaphylactic reaction
preobčutljivost preobčutjivost za zdravilo anafilaktična reakcija
Hepatobiliary disorders Rare Jaundice Reproductive system and breast disorders Uncommon
Bolezni jeter, žolčnika in žolčevodov Redki Motnje reprodukcije in Občasni
Amenorrhoea, Sexual dysfunction, Erectile dysfunction, Ejaculation disorder, Galactorrhoea, Gynaecomastia, Menstrual disorder, Vaginal discharge,
zlatenica dojk amenoreja, spolna disfunkcija, motnje erekcije in ejakulacije, galaktoreja, ginekomastija, motnje menstrualnega ciklusa, izcedek iz nožnice,
Not known
Neznana Psihiatrične motnje
Very common Common Uncommon Rare
Zelo pogosti Pogosti Občasni Redki a
Insomnia Anxiety, Agitation, Sleep disorder Confusional state, Mania, Libido decreased, Listless, Nervousness Anorgasmia, Blunted affect
nespečnost tesnoba, agitacija, motnje spanja stanje zmedenosti, manija, zmanjšan libido, prebujanje ponoči, živčnost anorgazmija, otopelost
Parkinsonism (salivary hypersecretion, musculoskeletal stiffness, parkinsonism, drooling, cogwheel rigidity, bradykinesia, hypokinesia, masked facies, muscle tightness, akinesia, nuchal rigidity, muscle rigidity, parkinsonian gait, and glabellar reflex abnormal), akathisia (akathisia, restlessness, hyperkinesia, and restless leg syndrome), tremor, dyskinesia (dyskinesia, muscle twitching, choreoathetosis, athetosis, and myoclonus), dystonia.
Hiperprolaktinemija lahko v nekaterih primerih vodi do ginekomastije, motenj menstruacije, amenoreje in galaktoreje. b Lahko se pojavijo ekstrapiramidne motnje: parkinsonizem (povečano izločanje sline, muskuloskeletna togost, parkinsonizem, slinjenje, okorelost po tipu zobatega kolesa, bradikinezija, hipokinezija, obraz maske, mišična napetost, akinezija, okorel vrat, rigidnost mišic, parkinsonska drža in nenormalni glabelarni refleks), akatizija (akatizija, vznemirjenost, hiperkinezija in sindrom nemirnih nog), tremor, diskinezija (diskinezija, trzanje mišic, horeoatetoza, atetoza, in mioklonus), distonija.
The following is a list of additional ADRs associated with risperidone that have been identified as ADRs during clinical trials investigating the long-acting injectable risperidone formulation (RISPERDAL CONSTA) but were not determined to be ADRs in the clinical trials investigating oral RISPERDAL.
V spodnji tabeli so navedeni neželeni učinki, povezani z risperidonom, ki so se pojavili v kliničnih preskušanjih z risperidonom v obliki injekcij s podaljšanim sproščanjem (RISPERDAL CONSTA), niso pa bili poročani v kliničnih preskušanjih s peroralnimi oblikami zdravila RISPERDAL.
This table excludes those ADRs specifically associated with the formulation or injection route of administration of RISPERDAL CONSTA.
V tabeli ni tistih neželenih učinkov, ki so specifično povezani s farmacevtsko obliko ali načinom aplikacije v obliki injekcije zdravila RISPERDAL CONSTA.
Additional Adverse Drug Reactions Reported With RISPERDAL CONSTA but Not With Oral RISPERDAL by System Organ Class Investigations Weight decreased, Gamma-glutamyltransferase increased, Hepatic enzyme increased Cardiac Disorders Bradycardia Blood and Lymphatic Disorders Neutropenia Nervous System Disorders Paresthesia, Convulsion Eye Disorders Blepharospasm Ear and Labyrinth Disorders Vertigo Gastrointestinal Disorders Toothache, Tongue spasm Skin and Subcutaneous Tissue Disorders Eczema Musculoskeletal, Connective Tissue, and Bone Disorders Buttock pain Infections and Infestations Lower respiratory tract infection, Infection, Gastroenteritis, Subcutaneous abscess Injury and Poisoning Fall Vascular Disorders Hypertension General Disorders and Administration Site Conditions Pain Psychiatric Disorders Depression
Neželeni učinki, ki so jih poročali pri uporabi zdravila RISPERDAL CONSTA, ne pa pri uporabi peroralnih oblik zdravila RISPERDAL, razvrščeni po organskih sistemih Preiskave zmanjšanje telesne mase, zvišana gama glutamiltransferaza, zvišanje jetrnih encimov Srčne bolezni bradikardija Bolezni krvi in limfatičnega sistema nevtropenija Bolezni živčevja parestezije, krči
64 Class effects
64 Očesne bolezni blefarospazem Ušesne bolezni, vključno z motnjami labirinta vertigo Bolezni prebavil zobobol, krč jezika Bolezni kože in podkožja ekcem Bolezni mišično- skeletnega sistema in vezivnega tkiva bolečine v zadnjici Infekcijske in parazitske bolezni okužba spodnjih dihal, okužba, gastroenteritis, podkožni absces Poškodbe in zastrupitve padci Žilne bolezni hipertenzija Splošne težave in spremembe na mestu aplikacije bolečine Psihiatrične motnje depresija
Other class-related cardiac effects reported with antipsychotics which prolong QT interval include ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest and Torsades de Pointes.
Ostali vplivi na srce, pri tej skupini zdravil, ki so jih poročali pri uporabi antipsihotikov, ki podaljšujejo QT interval so ventrikularna aritmija, ventrikularna fibrilacija, ventrikularna tahikardija, nenadna smrt, srčni zastoj in Torsades de pointes.
The proportions of RISPERDAL and placebo-treated adult patients with schizophrenia meeting a weight gain criterion of ≥ 7% of body weight were compared in a pool of 6- to 8-week, placebo-controlled trials, revealing a statistically significantly greater incidence of weight gain for RISPERDAL (18%) compared to placebo (9%).
Z združevanjem podatkov 6 do 8 tedenskih, s placebom nadzorovanih preskušanjih so primerjali odstotke odraslih bolnikov s shizofrenijo, ki so prejemali zdravilo RISPERDAL in placebo, ki so izpolnjevali kriterij telesne mase, to je za ≥ 7% povečanje telesne mase in ugotovili statistično značilno večjo nagnjenost k povečanju telesne mase pri zdravilu RISPERDAL (18%) v primerjavi s placebom (9%).
In a pool of placebo-controlled 3-week studies in adult patients with acute mania, the incidence of weight increase of ≥ 7% at endpoint was comparable in the RISPERDAL (2.5%) and placebo (2.4%) groups, and was slightly higher in the active-control group (3.5%).
Z združevanjem podatkov 3- tedenskih, s placebom nadzorovanih preskušanj pri odraslih bolnikih z akutno manijo, je bilo nagnjenje za povečanje telesne mase ≥ 7% na koncu preskušanja, primerljivo v skupinah, ki sta prejemali RISPERDAL (2, 5%) in placebo (2, 4%) in je bilo rahlo višje v aktivni kontrolni skupini (3, 5%).
In a population of children and adolescents with conduct and other disruptive behaviour disorders, in long- term studies, weight increased by a mean of 7.3 kg after 12 months of treatment.
V dolgoročnih študijah pri otrocih in mladostnikih z vedenjskimi motnjami in drugimi razdiralni motnjami vedenja se je po 12 mesecih zdravljenja telesna masa povprečno povečala za 7, 3 kg.
The expected weight gain for normal children between 5-12 years of age is 3 to 5 kg per year.
Pričakovano povečanje telesne mase pri normalnih otrocih med 5 in 12 letom starosti je 3 do 5 kg na leto.
From 12-16 years of age, this magnitude of gaining 3 to 5 kg per year is maintained for girls, while boys gain approximately 5 kg per year.
Od 12 - 16 leta starosti deklice še vedno pridobivajo 3 do 5 kg na leto medtem, ko fantje pridobivajo približno 5 kg na leto.
Adverse drug reactions that were reported with higher incidence in elderly patients with dementia or paediatric patients than in adult populations are described below:
Neželeni učinki, ki so se pogosteje kot pri odraslih bolnikih, pojavljali pri starejših bolnikih z demenco ali pediatričnih bolnikih so opisani spodaj:
Elderly patients with dementia
65 Starejši bolniki z demenco
Transient ischaemic attack and cerebrovascular accident were ADRs reported in clinical trials with a frequency of 1.4% and 1.5%, respectively, in elderly patients with dementia.
Pri starejših bolnikih z demenco so v kliničnih preskušanjih poročali o prehodnem ishemičnem napadu in cerebrovaskularnih dogodkih, s pogostnostjo 1, 4% oziroma 1, 5%.
In addition, the following ADRs were reported with a frequency ≥ 5% in elderly patients with dementia and with at least twice the frequency seen in other adult populations: urinary tract infection, peripheral oedema, lethargy, and cough.
Dodatno so se naslednji neželeni učinki pojavljali pri starejših bolnikih z demenco s pogostnostjo ≥ 5% in vsaj dvakrat večjo pogostnostjo kot pri ostali odrasli populaciji: okužbe urinarnega trakta, periferni edem, letargija in kašelj.
The following ADRs were reported with a frequency ≥ 5% in paediatric patients (5 to 17 years) and with at least twice the frequency seen in clinical trials in adults: somnolence/ sedation, fatigue, headache, increased appetite, vomiting, upper respiratory tract infection, nasal congestion, abdominal pain, dizziness, cough, pyrexia, tremor, diarrhoea, and enuresis.
Naslednji neželeni učinki so bili pri pediatričnih bolnikih (5 do 17 let) poročani s pogostnostjo ≥ 5% in vsaj dvakrat pogosteje kot v kliničnih preskušanjih pri odraslih: somnolenca/ sedacija, utrujenost, glavobol, povečan apetit, bruhanje, okužba zgornjih dihal, zamašen nos, bolečine v trebuhu, vrtoglavica, kašelj, zvišana telesna temperatura, tremor, driska, enureza.
In general, reported signs and symptoms have been those resulting from an exaggeration of the known pharmacological effects of risperidone.
Na splošno so znaki in simptomi prevelikega odmerjanja, o katerih so poročali, posledica zvečanja znanih farmakoloških učinkov risperidona.
These include drowsiness and sedation, tachycardia and hypotension, and extrapyramidal symptoms.
Ti vključujejo dremavost in sedacijo, tahikardijo, hipotenzijo in ekstrapiramidne znake.
In overdose, QT-prolongation and convulsions have been reported.
Podatki, ki so na voljo, govorijo o velikem varnostnem razponu.
Torsade de Pointes has been reported in association with combined overdose of RISPERDAL and paroxetine.
O Torsades de pointes so poročali v povezavi s prevelikimi odmerki sočasne uporabe zdravila RISPERDAL in paroksetina.
In case of acute overdose, the possibility of multiple drug involvement should be considered.
V primeru akutnega prevelikega odmerka je treba pomisliti še na druga prisotna zdravila.
Establish and maintain a clear airway and ensure adequate oxygenation and ventilation.
Potrebno je vzpostaviti in vzdrževati proste dihalne poti ter zagotoviti primerno oksigenacijo in ventilacijo.
Gastric lavage (after intubation, if the patient is unconscious) and administration of activated charcoal together with a laxative
Če je od zaužitja zdravila minila manj kot ena ura, priporočamo izpiranje želodca (po intubaciji, če je bolnik brez zavesti) ter uporabo aktivnega oglja in odvajal.
65 should be considered only when drug intake was less than one hour before.
Od vsega začetka moramo nadzorovati kardiovaskularni sistem (monitoring).
Therefore, appropriate supportive measures should be instituted.
Za zdravilo RISPERDAL ni specifičnega antidota, zato uporabljamo ustrezne podporne ukrepe.
Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids and/ or sympathomimetic agents.
Hipotenzijo in cirkulatorni kolaps zdravimo s primernimi ukrepi, kot so intravenske tekočine in/ ali simpatikomimetiki.
In case of severe extrapyramidal symptoms, an anticholinergic medicinal product should be administered.
V primeru hudih ekstrapiramidnih znakov uporabimo antiholinergična zdravila.
5.1 Pharmacodynamic properties
5. 1 Farmadinamične lastnosti
Other antipsychotics, ATC code:
Farmakoterapevtska skupina: drugi antipsihotiki, Oznaka ATC:
Risperidone is a selective monoaminergic antagonist with unique properties.
Risperidon je selektiven monoaminergičen antagonist z edinstvenimi lastnostmi.
It has a high affinity for serotoninergic 5-HT2 and dopaminergic D2 receptors.
Ima veliko afiniteto za serotoninske receptorje 5- HT2 in dopaminske receptorje D2.
Risperidone binds also to alpha1-adrenergic receptors, and, with lower affinity, to H1-histaminergic and alpha2-adrenergic receptors.
Risperidon se veže tudi na alfa1 adrenergične receptorje in z manjšo afiniteto na histaminske H1 in alfa2 adrenergične receptorje.
Risperidone has no affinity for cholinergic receptors.
Risperidon nima afinitete za vezavo na holinergične receptorje.
Although risperidone is a potent D2 antagonist, which is considered to improve the positive symptoms of schizophrenia, it causes less depression of motor activity and induction of catalepsy than classical antipsychotics.
Čeprav je močan D2 antagonist, kar verjetno povzroča izboljšanje pozitivnih znakov shizofrenije, zavira motorično aktivnost v manjši meri in povzroča manj
Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.
Uravnoteženo osrednje antagonistično delovanje serotonina in dopamina lahko zmanjša občutljivost za ekstrapiramidne neželene učinke in razširi terapevtsko učinkovitost na negativne in afektivne znake shizofrenije.
The efficacy of risperidone in the short-term treatment of schizophrenia was established in four studies, 4- to 8-weeks in duration, which enrolled over 2500 patients who met DSM-IV criteria for schizophrenia.
Učinkovitost kratkoročnega zdravljenja shizofrenije z risperidonom so ocenili v štirih študijah, ki so trajale 4 do 8 tednov in so vključevale 2500 bolnikov, ki so ustrezali DSM- IV kriterijem za shizofrenijo.
In a 6- week, placebo-controlled trial involving titration of risperidone in doses up to 10 mg/ day administered twice daily, risperidone was superior to placebo on the Brief Psychiatric Rating Scale (BPRS) total score.
V 6- tedenskem, s placebom nadzorovanem preskušanju, ki je vključeval titriranje risperidona do odmerkov 10 mg/ dan, razdeljeno na dva odmerka, se je risperidon izkazal za učinkovitejšega v primerjavi s placebom glede na celoten rezultat po BPRS (Brief Psychiatric Rating Scale) lestvici.
In an 8- week, placebo-controlled trial involving four fixed doses of risperidone (2, 6, 10, and 16 mg/ day, administered twice daily), all four risperidone groups were superior to placebo on the Positive and Negative Syndrome Scale (PANSS) total score.
V 8- tedenskem, s placebom nadzorovanem preskušanju, kjer so risperidon dajali v štirih določenih odmerkih (2, 6, 10 in 16 mg/ dan, razdeljeno na dva odmerka), se je risperidon, v celotnem rezultatu po lestvici PANSS (Positive and negative Syndrome Scale), v vseh štirih odmerkih, izkazal za učinkovitejšega v primerjavi s placebom.
In an 8-week, dose comparison trial involving five fixed doses of risperidone (1, 4, 8, 12, and 16 mg/ day administered twice-daily), the 4, 8, and 16 mg/ day risperidone dose groups were superior to the 1 mg risperidone dose group on PANSS total score.
V 8- tedenskem, preskušanju primerjave odmerkov, kjer so risperidon dajali v petih določenih odmerkih (1, 4, 8, 12 in 16 mg/ dan, razdeljeno na dva odmerka), so bili rezultati v skupinah, ki so prejemale odmerke 4, 8 in 16 mg/ dan boljši v celotnem rezultatu PANSS v primerjavi s skupino, ki je prejemala 1 mg risperidona.
In a 4-week, placebo- controlled dose comparison trial involving two fixed doses of risperidone (4 and 8 mg/ day administered once daily), both risperidone dose groups were superior to placebo on several PANSS measures, including total PANSS and a response measure (> 20% reduction in PANSS total score).
V 4- tedenskem, s placebom nadzorovanem preskušanju primerjave odmerkov, kjer so risperidon dajali v dveh določenih odmerkih (4 in 8 mg/ dan), so bili rezultati v obeh skupinah, ki sta prejemali risperidon boljši v primerjavi s skupino, ki je prejemala placebo v več meritvah PANSS, vključno s celotnim rezultatom PANSS in stopnjo odziva (> 20% zmanjšanje skupne ocene po lestvici PANSS).
In a longer-term trial, adult outpatients predominantly meeting DSM-IV criteria for schizophrenia and who had been clinically stable for at least 4 weeks on an antipsychotic medicinal product were randomised to risperidone 2 to 8 mg/ day or to haloperidol for 1 to 2 years of observation for relapse.
Randomizirani so bili v skupini, ki sta 1 do 2 leti prejemali 2 do 8 mg/ dan risperidona ali haloperidol.
Patients receiving risperidone experienced a significantly longer time to relapse over this time period compared to those receiving haloperidol.
Pri bolnikih, ki so prejemali risperidon je bil čas do ponovnega pojava simptomov shizofrenije, v tem časovnem obdobju, daljši kot pri tistih, ki so prejemali haloperidol.
The efficacy of risperidone monotherapy in the acute treatment of manic episodes associated with bipolar I disorder was demonstrated in three double-blind, placebo-controlled monotherapy studies in approximately 820 patients who had bipolar I disorder, based on DSM-IV criteria.
Učinkovitost risperidona v monoterapiji akutnega zdravljenja maničnih epizod, ki so povezane z bipolarno motnjo tipa I, so ocenjevali v treh dvojno- slepih, s placepom nadzorovanih študij monoterapije, pri približno 820 bolnikih z bipolarno motnjo tipa I, ki so ustrezali DSM- IV kriterijem.
In the three studies, risperidone 1 to 6 mg/ day (starting dose 3 mg in two studies and 2 mg in one study) was shown to be significantly superior to placebo on the pre-specified primary endpoint, i. e., the change from baseline in total Young Mania Rating
V treh študijah je bil risperidon v odmerkih 1 do 6 mg/ dan (začetni odmerek v dveh študijah je bil 3 mg, v eni pa 2 mg) značilno učinkovitejši, glede na vnaprej postavljen primarni cilj, v primerjavi s placebom, kjer je bila sprememba skupne ocene po lestvici YMRS (Young Mania Rating Scale) glede na izhodiščno vrednost v 3. tednu.
Secondary efficacy outcomes were generally consistent with the primary outcome.
Sekundarni rezultati učinkovitosti so bili večinoma v skladu s primarnimi.
The percentage of patients with a decrease of ≥ 50% in total YMRS score from baseline to the 3-week endpoint was significantly higher for risperidone than for placebo.
Odstotek bolnikov z ≥ 50% zmanjšanjem skupne ocene po lestvici YMRS v 3. tednu, glede na izhodiščno vrednost, je bil pri risperidonu značilno višji kot pri placebu.
Efficacy was maintained throughout the 9-week maintenance treatment period.
Ena izmed treh študij je vključevala skupino s haloperidolom in 9- tedensko dvojno slepo vzdrževalno fazo.
Change from baseline in total YMRS showed continued improvement and was comparable between risperidone and haloperidol at Week 12.
Sprememba skupne ocene po YMRS glede na izhodiščno vrednost je kazala na stalno izboljševanje in je bila ob 12. tednu primerljiva med risperidonom in haloperidolom.
The efficacy of risperidone in addition to mood stabilisers in the treatment of acute mania was demonstrated in one of two 3-week double-blind studies in approximately 300 patients who met the DSM-IV criteria for bipolar I disorder.
Učinkovitost zdravljenja akutne manije z risperidonom, dodanim k stabilizatorjem razpoloženja je bila prikazana v eni od dveh 3- tedenskih dvojno slepih študijah, pri približno 300 bolnikih, ki so ustrezali DSM- IV kriterijem za bipolarno motnjo tipa I.
In one 3-week study, risperidone 1 to 6 mg/ day starting at 2 mg/ day in addition to lithium or valproate was superior to lithium or valproate alone on the pre-specified primary endpoint, i. e., the change from baseline in YMRS total score at Week 3.
V 3- tedenski študiji je bilo zdravljenje z dodatkom 1 do 6 mg/ dan risperidona z začetnim odmerkom 2 mg/ dan k litiju ali valproatu uspešnješe kot sama litij ali valproat, glede na vnaprej postavljen primarni cilj, ki je bil sprememba skupne ocene po lestvici YMRS (Young Mania Rating Scale) glede na izhodiščno vrednost v 3. tednu.
In a second 3-week study, risperidone 1 to 6 mg/ day starting at 2 mg/ day, combined with lithium, valproate, or carbamazepine was not superior to lithium, valproate, or carbamazepine alone in the reduction of YMRS total score.
V drugi 3- tedenski študiji 1 do 6 mg/ dan risperidona z začetnim odmerkom 2 mg/ dan skupaj z litijem, valproatom ali karbamazepinom ni bilo uspešnejše kot sam litij, valproat ali karbamazepin v zmanjšanju skupne ocene po lestvici YMRS.
A possible explanation for the failure of this study was induction of risperidone and 9-hydroxy-risperidone clearance by carbamazepine, leading to subtherapeutic levels of risperidone and 9-hydroxy-risperidone.
67 karbamazepinom, kar je pripeljalo do vrednosti risperidona in 9- hidroksi- risperidona, ki so nižje od terapevtskih.
When the carbamazepine group was excluded in a post-hoc analysis, risperidone combined with lithium or valproate was superior to lithium or valproate alone in the reduction of YMRS total score.
Ko so v post hoc analizi izpustili podatke iz skupine s karbamazepinom, je bil risperidon skupaj z litijem in valproatom uspešnejši pri zmanjšanju skupne ocene po lestvici YMRS kot litij in valproat sama.
Persistent aggression in dementia
Dolgotrajna agresija pri bolnikih z demenco
The efficacy of risperidone in the treatment of Behavioural and Psychological Symptoms of Dementia (BPSD), which includes behavioural disturbances, such as aggressiveness, agitation, psychosis, activity, and affective disturbances was demonstrated in three double-blind, placebo-controlled studies in 1150 elderly patients with moderate to severe dementia.
Učinkovitost risperidona pri zdravljenju vedenjskih in psiholoških simptomov demence (Behavioural and Psychological Symptoms of Dementia - BPSD), ki vključujejo vedenjske motnje, kot so agresija, agitacija, psihoza, motnje aktivnosti in čustvovanja je bila prikazana v treh dvojno slepih s placebom nadzorovanih preskušanjih pri 1150 starejših bolnikih z zmerno do hudo demenco.
One study included fixed risperidone doses of 0.5, 1, and 2 mg/ day.
Ena študija je vključevala določene odmerke risperidona 0, 5, 1 in 2 mg/ dan.
Two flexible-dose studies included risperidone dose groups in the range of 0.5 to 4 mg/ day and 0.5 to 2 mg/ day, respectively.
Dve študiji s poljubnim odmerkom risperidona sta vključevali dve skupini z odmerki od 0, 5 do 4 mg/ dan ter 0, 5 do 2 mg/ dan.
Risperidone showed statistically significant and clinically important effectiveness in treating aggression and less consistently in treating agitation and psychosis in elderly dementia patients (as measured by the Behavioural Pathology in Alzheimer’ s Disease Rating Scale [BEHAVE-AD] and the Cohen-Mansfield Agitation Inventory [CMAI]).
Risperidon je bil statistično značilno boljši in klinično pomembnejši pri zdravljenju agresije, in manj uspešen pri zdravljenju agitacije in psihoze pri starejših bolnikih z demenco (merjeno po BEHAVE- AD (Behavioural Pathology in Alzheimer’ s Disease) in CMAI (Cohen- Mansfield Agitation Inventory lestvici).
(See also section 4.4)
Učinek zdravljenja z risperidonom je bil neodvisen od rezultatov kratkega preizkusa spoznavnih sposobnostih (KPSS) (in posledično od stopnje demence); od sedativnih lastnosti risperidona; od prisotnosti ali odsotnosti psihoze in od vrste demence, Alzheimerjeve, vaskularne ali mešane (glejte tudi poglavje 4. 4).
The efficacy of risperidone in the short-term treatment of disruptive behaviours was demonstrated in two double-blind placebo-controlled studies in approximately 240 patients 5 to 12 years of age with a DSM-IV diagnosis of disruptive behaviour disorders (DBD) and borderline intellectual functioning or mild or moderate mental retardation/ learning disorder.
Učinkovitost risperidona pri kratkotrajnem zdravljenju razdiralnih motenj vedenja je bila prikazana v dveh dvojno slepih, s placebom nadzorovanih preskušanjih, pri približno 240 bolnikih starih 5 do 12 let z diagnozo razdiralne motnje vedenja po DSM- IV in podpovprečnimi inteligenčnimi sposobnostmi ali blago do zmerno duševno manjrazvitostjo/ težavami pri učenju.
In the two studies, risperidone 0.02 to 0.06 mg/ kg/ day was significantly superior to placebo on the pre-specified primary endpoint, i. e., the change from baseline in the Conduct Problem subscale of the Nisonger-Child Behaviour Rating Form (N-CBRF) at Week 6.
V teh dveh študijah je bil risperidon v odmerkih 0, 02 do 0, 06 mg/ kg/ dan značilno bolj učinkovit kot placebo glede na vnaprej postavljen primarni cilj: sprememba skupne ocene po lestvici N- CBRF (Nisonger- Child Behaviour Rating Form) glede na izhodiščno vrednost v 6. tednu.