natgillin/translations-raw huggingface dataset:
15 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.
For section 4.2, the CHMP discussed the Risperdal Consta starting dose (25 mg, intramuscular, every 2 weeks), considering the data provided by the MAH, and was of the opinion that the recommendation in the SPC that treatment should be started with the dose of 25 mg every two weeks should be maintained.
V poglavju 4. 2 je CHMP posebno pozornost namenil začetnemu odmerku zdravila Risperdal Consta (25 mg, intramuskularno, vsaka dva tedna), upoštevajoče predložene podatke imetnika dovoljenja za promet z zdravilom in menil, da je treba obdržati priporočilo v povzetku glavnih značilnosti zdravila, ki pravi, da naj bo začetni odmerek zdravljenja 25 mg vsaka dva tedna.
“ For most patients the recommended dose is 25 mg intramuscular every two weeks.
„ Za večino bolnikov je priporočen odmerek 25 mg intramuskularno, vsaka dva tedna.
For those patients on a fixed dose of oral risperidone for two weeks or more, the following conversion scheme should be considered.
Za bolnike, ki prejemajo točno določen odmerek peroralnega risperidona že dva tedna ali več, se priporoča naslednji načrt spremembe zdravljenja:
Patients treated with a dosage of 4 mg or less oral risperidone should receive 25 mg Risperdal Consta, while patients treated with higher oral doses should be considered for the higher Risperdal Consta dose of 37.5 mg.
Bolniki zdravljeni z odmerkom 4 mg ali manj peroralnega risperidona naj prejmejo odmerek 25 mg zdravila Risperdal Consta, pri bolnikih, zdravljenih z večjim odmerkom peroralnega zdravila pa se naj preuči možnost večjega, 37, 5 mg odmerka zdravila Risperdal Consta.
Where patients are not currently taking oral risperidone, the oral pre-treatment dosage should be considered when choosing the i. m. starting dose.
Pri bolnikih, ki trenutno ne prejemajo oralnega risperidona, je pri določitvi intramuskularnega začetnega odmerka potrebno preučiti odmerek predhodnega zdravljenja s peroralnim zdravilom.
Patients on higher dosages of the used oral antipsychotic should be considered for the higher Risperdal Consta dose of 37.5 mg .”
Pri bolnikih, ki prejemajo večje odmerke uporabljenega peroralnega antipsihotika, naj se preuči možnost uporabe večjega odmerka, 37, 5 mg zdravila Risperdal Consta. “
The CHMP also assessed the proposed 12.5 mg dosing, in particular with regards to the elderly population, and considered that the 12.5 mg dose of Risperdal Consta would provide additional dosing flexibility but stressed that this dose is intended only as a lower initial dose to establish tolerability, to be used mainly for patients with a higher sensitivity to the effects of the drug, either because of reduced metabolism/ excretion, or in patients with an intrinsic lower tolerability to psychotropic medication.
CHMP je preučil tudi predlagan odmerek 12, 5 mg, zlasti glede uporabe pri starejši populaciji in menil, da bi 12, 5 mg odmerek zdravila Risperdal Consta zagotovil dodatno fleksibilnost pri odmerjanju ter hkrati poudaril, da je takšen odmerek namenjen le kot manjši začetni odmerek za oblikovanje tolerabilnosti pri bolnikih z večjo občutljivostjo na učinke zdravila zaradi upočasnjenega presnavljanja // izločanja ali pa pri bolnikih z notranjo slabšo toleranco na psihotropna zdravila.
This was reflected in the harmonised wording of the SPC, along with the statement “ The efficacy of the 12.5 mg dose has not been investigated in clinical trials”.
To se odraža tudi v usklajenem besedilu povzetka glavnih značilnosti zdravila, skupaj z izjavo:
Furthermore, the PK of Risperdal Consta in the elderly population was adequately described, and it was shown that the pharmacokinetics in the population > 65 years are comparable to the population < 65 years.
„ Učinkovitost 12, 5 mg odmerka ni bila preverjena s kliničnimi preskušanji. “ Poleg tega je ustrezno opisana tudi farmakokinetika zdravila Risperdal Consta pri starejši populaciji, ki kaže, da je farmakokinetika pri populaciji > 65 let primerljiva s farmakokinetiko pri populaciji < 65 let.
If Risperdal Consta is used in accordance with the SPC recommendations for dosing, no particular safety or efficacy risks for the patient would be foreseen, even if acutely ill.
Če se zdravilo Risperdal Consta odmerja v skladu z navodili v povzetku glavnih značilnosti zdravila, za bolnike,
“ Risperdal Consta should not be used in acute exacerbations of schizophrenia without ensuring sufficient antipsychotic coverage with oral risperidone or the previous antipsychotic during the three- week lag period following the first Risperdal Consta injection .”
Odbor za zdravila za uporabo v humani medicini je tako sprejel naslednje besedilo za poglavje 4. 2:
Finally, the CHMP discussed the use of Risperdal Consta in patients previously treated with oral risperidone at doses ≥ 6mg/ day and noted that the provided efficacy data of these patients, when
„ Zdravilo Risperdal Consta naj se ne uporablja pri akutnih eksacerbacijah shizofrenije brez ustrezne zagotovitve antipsihotičnega kritja s peroralnim risperidonom ali predhodnim antipsihotikom v času tritedenskega obdobja prilagajanja po prvem injiciranju zdravila Risperdal Consta. “
16 switched to Risperdal Consta, were not different from the data obtained after previous oral risperidone treatment, despite the high probability of lower plasma level of risperidone being reached.
CHMP je razpravljal tudi o uporabi zdravila Risperdal Consta pri bolnikih, predhodno zdravljenimi z odmerki peroralnega risperidona ≥6 mg/ dan in menil, da se razpoložljivi podatki o učinkovitosti pri teh bolnikih, ko so prešli iz svojega dosedanjega zdravila na zdravilo Risperdal Consta, ne razlikujejo od podatkov pridobljenih po predhodnem zdravljenju s peroralnim risperidonom, ne glede na visoko verjetnost doseganja nižjih ravni plazemske koncentracije risperidona.
The CHMP was also of the opinion that doses of risperidone > 8 mg/ day should not be routinely used and should be restricted to certain group of patients.
CHMP je menil, da se odmerkov risperidona > 8mg ne bi smelo rutinsko predpisovati ter da naj bodo omejeni le na določene skupine bolnikov.
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.
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.
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.
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.
For section 4.3, the CHMP discussed the relevance of a Contraindication warning for patients with high risk factors for cerebrovasular adverse events.
V poglavju 4. 3 je CHMP preučil pomen opozorila glede kontraindikacij pri bolnikih z visokim faktorjem tveganja za cerebrovaskularne neželene dogodke.
Because Risperdal Consta has not been studied in elderly patients with dementia, it is therefore not indicated for use in this group of patients, as stated in Section 4.4 of the proposed SPC and in line with the current CHMP SPC guideline.
Ker uporaba zdravila Risperdal Consta pri starejših bolnikih z demenco ni bila raziskana, zdravilo za to skupino bolnikov, v skladu z navedbo v poglavju 4. 4 predlaganega povzetka glavnih značilnosti zdravila in v skladu s trenutnimi smernicami CHMP glede povzetkov glavnih značilnosti zdravila, ni indicirano.
For section 4.4, the CHMP implemented the wording on tardive dyskinesia, agreed upon by the Pharmacovigilance Working Party.
V poglavju 4. 4 je CHMP sprejel besedilo glede tardivne diskinezije, o katerem se je strinjala tudi delovna skupina za farmakovigilanco.
“ Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
„ Študije kultur tkiv nakazujejo, da prolaktin morda stimulira rast celic v tumorjih dojk pri ljudeh.
Although no clear association with the administration of antipsychotics has so far been demonstrated in clinical and epidemiological studies, caution is recommended in patients with a relevant medical history.
Čeprav dosedanje klinične in epidemiološke raziskave niso jasno dokazale povezave z uporabo antipsihotikov, se pri bolnikih z relevantno medicinsko zgodovino priporoča posebna previdnost.
Risperdal should be used with caution in patients with pre-existing hyperprolactinaemia and in patients with possibly prolactin-dependent tumours .”
Zdravilo Risperdal naj se uporablja s posebno previdnostjo pri bolnikih s predhodno hiperprolaktinemijo in pri bolniki z tumorji, katerih nastanek je morda povezan s prolaktinom. “
For section 4.6, the CHMP discussed the wording, moving the mention of galactorrhea to section 4.8 and adopting the following harmonised wording:
17 V poglavju 4. 6 je CHMP preučil besedilo in premaknil omembo galaktoreje v poglavje 4. 8 ter sprejel naslednje usklajeno besedilo:
“ It has been demonstrated that risperidone and 9-hydroxy-risperidone are also excreted in human breast-milk in small quantities.
„ Dokazano je bilo, da se risperidon in 9- hidroksi- risperidon v majhnih količinah izločata tudi v materino mleko.
Therefore, the advantage of breast-feeding should be weighed against the potential risks for the child .”
Tako je potrebno preučiti prednosti dojenja v primerjavi z možnimi tveganji za otroka. “
For section 4.8, the CHMP assessed and harmonised the wording.
V poglavju 4. 8 je CHMP preučil in uskladil besedilo.
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. “ Sedation” should be separated from “ somnolence” and not grouped by the term “ sedation”.
„ Sedacija “ naj bo ločena od „ somnolence “ in ne zaobjeta z izrazom „ sedacija “.
Furthermore, « Anxiety » and « nervousness » should be separated and not grouped by the term “ anxiety”.
Poleg tega je treba ločiti tudi „ anksioznost “ in „ nervozo “ in ju ne zaobjeti z izrazom „ anksioznost “.
Finally, « Extrapyramidal symptoms » should be the grouped term in the subparagraph Nervous System Disorders and the single symptoms should be mentioned with an
„ Ekstrapiramidni simptomi “ naj bodo skupni izraz v podskupini nervozne sistemske motnje, posamezni simptomi pa naj bodo označeni z zvezdico.
As already mentioned, hypersalivation/ drooling should be added to « EPS » as otherwise incidence of EPS is underestimated.
Hipersialoza/ slinjenje naj bo vključeno v „ ekstrapiramidne neželene učinke “, saj je drugače pojavnost ekstrapiramidnih neželenih učinkov podcenjena.
labelling and package leaflet,
uporabo,
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing
- da so bili povzetki glavnih značilnosti zdravila, označevanj in navodil za uporabo, ki so jih predlagali
Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
imetniki dovoljenj za promet z zdravilom, ovrednoteni na podlagi predložene dokumentacije in strokovne razprave v Odboru,
RISPERDAL CONSTA and associated names (see Annex I) 12.5 mg powder and solvent for prolonged-release suspension for intramuscular injection [See Annex I – To be completed nationally]
Risperdal Consta® in sorodna imena (glejte Dodatek 1) 12, 5 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem [Glejte Dodatek 1 – poglavje bo dopolnjeno nacionalno]
RISPERDAL CONSTA and associated names (see Annex I) 25 mg powder and solvent for prolonged- release suspension for intramuscular injection
RISPERDAL CONSTA® in sorodna imena (glejte Dodatek 1) 25 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
RISPERDAL CONSTA and associated names (see Annex I) 37.5 mg powder and solvent for prolonged-release suspension for intramuscular injection
RISPERDAL CONSTA® in sorodna imena (glejte Dodatek 1) 37, 5 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
RISPERDAL CONSTA and associated names (see Annex I) 50 mg powder and solvent for prolonged- release suspension for intramuscular injection
RISPERDAL CONSTA® in sorodna imena (glejte Dodatek 1) 50 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem
Adults Starting dose:
Odrasli Začetni odmerek:
For most patients the recommended dose is 25 mg intramuscular every two weeks.
Za večino bolnikov je priporočeni začetni odmerek 25 mg intramuskularno vsaka dva tedna.
Patients treated with a dosage of 4 mg or less oral risperidone should receive 25 mg RISPERDAL CONSTA, while patients treated with higher oral doses should be considered for the higher RISPERDAL CONSTA dose of 37.5 mg.
Bolniki, ki jemljejo 4 mg ali manj risperidona v peroralni obliki, bi morali prejeti 25 mg zdravila RISPERDAL CONSTA, pri bolnikih, ki so prej prejemali večje odmerke risperidona v peroralni obliki pa je treba razmisliti o uporabi višjih odmerkov (37, 5 mg) zdravila RISPERDAL CONSTA.
Where patients are not currently taking oral risperidone, the oral pre-treatment dosage should be considered when choosing the i. m. starting dose.
Pri bolnikih, ki trenutno ne jemljejo risperidona v peroralni obliki, je treba pred izbiro začetnega intramuskularnega odmerka razmisliti o predhodnem peroralnem dajanju risperidona.
The recommended starting dose is 25 mg RISPERDAL CONSTA every two weeks.
Priporočeni začetni odmerek zdravila RISPERDAL CONSTA je 25 mg vsaka dva tedna.
Patients on higher dosages of the used oral antipsychotic should be considered for the higher RISPERDAL CONSTA dose of 37.5 mg.
Pri bolnikih, ki jemljejo večje odmerke antipsihotikov v peroralni obliki, je treba razmisliti o uporabi višjih odmerkov (37, 5 mg) zdravila RISPERDAL CONSTA.
A lower initial dose of 12.5 mg may be appropriate when clinical factors warrant dose adjustment, such as in patients with hepatic or renal impairment, for certain drug interactions that increase risperidone plasma concentrations (see section 4.5), or in patients who have a history of poor tolerability to psychotropic medications.
21 Pri bolnikih z ledvično in jetrno okvaro, bolnikih ki jemljejo zdravila, ki povečujejo plazemsko koncentracijo risperidona (glejte poglavje 4. 5) ali pri bolnikih, ki slabo prenašajo psihotropna zdravila je lahko začetni odmerek risperidona 12, 5 mg.
The efficacy of the 12.5 mg dose has not been investigated in clinical trials.
Učinkovitost 12, 5 mg odmerka risperidona ni bila dokazana v kliničnih preskušanjih.
21 Sufficient antipsychotic coverage with oral risperidone or the previous antipsychotic should be ensured during the three-week lag period following the first RISPERDAL CONSTA injection (see section 5.2).
V prvih treh tednih po prvem injiciranju zdravila RISPERDAL CONSTA je treba poskrbeti, da bolniki dodatno jemljejo ustrezen antipsihotik, risperidon v peroralni obliki ali antipsihotik, ki so ga jemali predhodno (glejte poglavje 5. 2).
RISPERDAL CONSTA should not be used in acute exacerbations of schizophrenia without ensuring sufficient antipsychotic coverage with oral risperidone or the previous antipsychotic during the three- week lag period following the first RISPERDAL CONSTA injection.
Pri akutnem poslabšanju shizofrenije se zdravila RISPERDAL CONSTA v tritedenskem obdobju do nastopa učinka, po prvem injiciranju, ne sme uporabljati brez zagotovitve primernega odmerka risperidona v peroralni obliki ali predhodno uporabljenega antipsihotika.
Some patients may benefit from the higher doses of 37.5 mg or 50 mg.
Nekaterim bolnikom lahko koristijo višji odmerki 37, 5 mg ali 50 mg.
Upward dosage adjustment should not be made more frequently than every 4 weeks.
Odmerka se ne sme zviševati pogosteje kot vsake 4 tedne.
In patients with clinical factors such as hepatic or renal impairment or certain drug interactions that increase risperidone plasma concentrations (see section 4.5), dose reduction as low as 12.5 mg may be appropriate.
Pri bolnikih z ledvično in jetrno okvaro in bolnikih, ki jemljejo zdravila, ki povečujejo plazemsko koncentracijo risperidona (glejte poglavje 4. 5), je primerno znižanje odmerka na 12, 5 mg.
Elderly No dose adjustment is required.
Starejši ljudje Odmerkov ni treba prilagajati.
For those patients on a fixed dose of oral risperidone for two weeks or more, the following conversion scheme should be considered.
Za bolnike, ki že dva tedna ali več jemljejo stalni odmerek peroralne oblike risperidona pa je predlagana naslednja shema zamenjave zdravila.
Patients treated with a dosage of 4 mg or less oral risperidone should receive 25 mg RISPERDAL CONSTA, while patients treated with higher oral doses should be considered for the higher RISPERDAL CONSTA dose of 37.5 mg.
Bolniki, ki jemljejo 4 mg ali manj peroralne oblike risperidona, bi morali prejeti 25 mg zdravila RISPERDAL CONSTA, pri bolnikih, ki so prej prejemali večje odmerke peroralnih oblik risperidona pa je treba razmisliti o uporabi višjih odmerkov (37, 5 mg) zdravila RISPERDAL CONSTA.
Sufficient antipsychotic coverage should be ensured during the three-week lag period following the first RISPERDAL CONSTA injection (see section 5.2).
V obdobju prvih treh tednov, po prvem injiciranju zdravila RISPERDAL CONSTA je treba zagotoviti nadomestilo z ustreznim antipsihotikom (glejte poglavje 5. 2).
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.
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.
Alternatively, a starting dose of RISPERDAL CONSTA of 12.5 mg may be appropriate.
Pri teh bolnikih bi lahko bil primeren začetni odmerek zdravila Risperdal Consta 12, 5 mg.
Paediatric population RISPERDAL CONSTA is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy.
22 Otroci in mladostniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti, uporaba zdravila RISPERDAL CONSTA pri otrocih in mladostnikih, mlajših od 18 let ni priporočljiva.
Injections should alternate between the buttocks.
Injiciramo izmenično v levo in desno zadnjično mišico.
Do not administer intravenously (see section 4.4 and section 6.6).
Zdravila ne dajemo intravensko (glejte poglavje 4. 4 in poglavje 6. 6).
22 For instructions on preparation and handling RISPERDAL CONSTA, see section 6.6.
Za navodila za pripravo in uporabo zdravila RISPERDAL CONSTA glejte poglavje 6. 6.
For risperidone-naive patients, it is recommended to establish tolerability with oral risperidone prior to initiating treatment with RISPERDAL CONSTA (see section 4.2).
Bolnike, ki še niso bili zdravljeni z risperidonom, moramo pred prvim injiciranjem zdravila RISPERDAL CONSTA najprej nekaj dni zdraviti z risperidonom v peroralni obliki, da ocenimo kako ga prenašajo (glejte poglavje 4. 2).
Elderly patients with dementia RISPERDAL CONSTA has not been studied in elderly patients with dementia, hence it is not indicated for use in this group of patients.
Starejši bolniki z demenco Zdravilo RISPERDAL CONSTA ni bilo preskušano pri starejših bolnikih z demenco, zato ni indicirano za uporabo pri tej skupini bolnikov.
Elderly patients with dementia treated with atypical antipsychotics have an increased mortality compared to placebo in a meta-analysis of 17 controlled trials of atypical antipsychotics, including oral RISPERDAL.
Pri starejši bolniki z demenco, ki se zdravijo z atipičnimi antipsihotiki, so v meta- analizi 17 nadzorovanih preskušanj z atipičnimi antipsihotičnimi zdravili, vključno s peroralno obliko zdravila RISPERDAL, ugotovili povečano pojavnost smrtnosti v primerjavi s placebom.
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 placebo- treated 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 odds ratio (95% exact confidence interval) was 1.21 (0.7, 2.1).
Razmerje verjetnosti (95% interval zaupanja) je bilo 1, 21 (0, 7; 2, 1).
The mean age (range) of patients who died was 86 years (range 67-100).
Povprečna starost (območje) umrlih bolnikov je bila 86 let (območje 67- 100).
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).
There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment with risperidone.
Pri sočasni uporabi risperidona z ostalimi diuretiki niso opazili povečane smrtnosti.
In placebo-controlled trials in elderly patients with dementia there was a significantly higher incidence (approximately 3-fold increased) of CVAEs, such as stroke (including fatalities) and transient ischaemic attack in patients treated with RISPERDAL compared with patients treated with placebo (mean age 85 years; range 73 to 97).
85 let, območje 73- 97).
The pooled data from six placebo-controlled studies in mainly elderly patients (> 65 years of age) with dementia showed that CVAEs (serious and non- serious, combined) occurred in 3.3% (33/ 1009) of patients treated with risperidone and 1.2% (8/ 712) of patients treated with placebo.
Skupni podatki šest, s placebom nadzorovanih študij pri večinoma starejših bolnikih (> 65 let) z demenco so pokazali, da so se cerebrovaskularni neželeni dogodki (resni in neresni, skupaj) pojavili pri 3, 3% (33/ 1009) bolnikov zdravljenih z risperidonom in 1, 2% (8/ 712) bolnikov zdravljenih s placebom.
The odds ratio (95% exact confidence interval) was 2.96 (1.34, 7.50).
Razmerje verjetnosti (95% interval zaupanja) je bilo 2, 96 (1, 34; 7, 50).
23 Orthostatic hypotension
Ortostatska hipotenzija
Risperidone should be used with caution in patients with known cardiovascular disease (e. g. heart failure, myocardial infarction, conduction abnormalities, dehydration, hypovolemia, or cerebrovascular disease).
Pri bolnikih z znano kardiovaskularno boleznijo (npr: srčno popuščanje, srčni infarkt, motnje prevajanja, dehidracija, hipovolemija ali cerebrovaskularna bolezen), se mora risperidon uporabljati previdno.