natgillin/translations-raw huggingface dataset:
A statement was included in section 4.4 on the risk in elderly patients with dementia treated concomitantly with furosemide and risperidone.
V poglavje 4. 4 je bila vključena izjava o tveganju pri starejših bolnikih z demenco, sočasno zdravljenimi s furosemidom in risperidonom.
The CHMP also implemented a number of revisions in the subsection on children and adolescents, in particular with regards to sedation and clinically significant weight gain.
CHMP je vključil tudi številne popravke podpoglavja o otrocih in mladostnikih, zlasti v zvezi s sedacijo in klinično pomembnim pridobivanjem teže.
For section 4.5, the CHMP assessed and harmonised wording on interactions with other medicinal products, discussing in particular torsades de pointes, products inhibiting the hepatic metabolism of risperidone the combination with other centrally-acting substances due to the increased risk of sedation and dopamine agonists.
V poglavju 4. 5 je CHMP ocenil in uskladil besedilo o medsebojnem delovanju z drugimi zdravili, s posebnim poudarkom na „ torsades de pointes “, zdravilih, ki zavirajo presnavljanje risperidona v jetrih v kombinaciji z drugimi osrednje delujočimi snovmi, zaradi povečanega tveganja za sedacijo in dopaminske agoniste.
The CHMP also deleted the mention of haloperidol, discussed interaction with verapamil and revised the wording on plasma concentrations.
CHMP je tudi izbrisal omembo haloperidola, razpravljal o medsebojnem delovanju z verapamilom in pregledal besedilo o plazemskih koncentracijah.
The CHMP also inserted texts on the interaction of risperidone with food.
Vstavil je tudi besedilo o medsebojnem delovanju risperidona s hrano.
For section 4.8, the CHMP assessed and completely revised the text of the SPC, taking into account new adverse event and tightening the section by revising the grouping of terms of adverse events.
50 V poglavju 4. 8 je CHMP ocenil in popolnoma uskladil besedilo v povzetku glavnih značilnosti zdravila, pri čemer je upošteval nove neželene učinke in skrajšal poglavje z revizijo združevanja izrazov neželenih učinkov.
Left and right bundle branch block were grouped together but sedation and somnolence, and anxiety and nervousness were ungrouped.
Levo - in desnokračni blok sta bila združena, sedacija in somnolenca ter anksioznost in nervoza pa niso združeni.
The CHMP decided not to group the extrapyramidal symptoms within the table of section 4.8 but revised the footnote referring to parkinsonism respectively extrapyramidal in section 4.8 and inserted a footnote for hyperprolactinaemia.
CHMP se je odločil, da ekstrapiramidnih simptomov ne bo združil v preglednico v poglavju 4. 8, ampak je revidiral le opombo, ki se je nanašala na parkinsonizem oziroma ekstrapiramidne simptome v poglavju 4. 8, ter vstavil opombo za hiperprolaktinemijo.
As a Condition of the Marketing Authorisation, the CHMP requested the MAH to commit to generate a collection of long-term data for the evaluation of long-term safety of risperidone in children and adolescents with conduct disorder in terms of potential effects on growth (height and weight), mental development, and sexual maturation (by Tanner stage).
Kot pogoj za dovoljenje za promet z zdravilom je CHMP od imetnika dovoljenja za promet z zdravilom zahteval, da sestavi zbirko dolgoročnih podatkov za ocenitev dolgoročne varnosti risperidona pri otrocih in mladostnikih z vedenjskimi motnjami z vidika možnih vplivov na rast (višino in težo), duševni razvoj in spolno dozorevanje (stadiji po Tannerju).
The study should also assess prolactin values and possible prolactin-related AEs.
Študija bi morala preučiti tudi vrednosti prolaktina in možne neželene učinke, povezane s prolaktinom.
Regarding cognitive assessment, the MAH should make a proposal as to how it would be possible to assess effects on cognitive development.
V zvezi s kognitivno oceno bi moral imetnik dovoljenja za promet z zdravilom pripraviti predlog o možnem načinu preučitve vpliva na kognitivni razvoj.
50 The CHMP assessed the proposal from the MAH to conduct an additional retrospective cohort study based on available medical records, in which information regarding prescription as well as Tanner staging and growth would be available.
CHMP je ocenil predlog imetnika dovoljenja za promet z zdravilom za izvedbo dodatne retrospektivne kohortne študije na podlagi razpoložljive medicinske evidence, v katerih bi bili na voljo podatki o predpisovanju ter o razvoju po stadijih Tannerja in rast.
As the treatment duration is now limited, the CHMP did not consider a prospective long-term study to be required.
Ker je trajanje zdravljenja sedaj omejeno, CHMP ni menil, da je potrebna prospektivna dolgoročna študija.
Finally, the CHMP noted that the Risperdal oral solution pipettes were updated in 2007 to include the graduation for each 0.25 mg with different designs depending on the size of the pipette.
Ne nazadnje je CHMP ugotovil, da so bile pipete za peroralno raztopino zdravila Risperdal v letu 2007 posodobljene in sedaj vključujejo stopnjevanje za vsakih 0, 25 mg z različnim vzorcem glede na velikost pipete.
A number of additional revisions were made to the SPC and the revisions made to the SPC were implemented accordingly in the labelling and the package leaflet.
V povzetku glavnih značilnosti zdravila je bilo narejenih več dodatnih revizij besedila, vse potrjene revizije pa so bile tudi ustrezno vključene v označevanje in navodilo za uporabo.
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, vse spremembe pa so bile vključene tudi v označevanje in navodilo za uporabo, s čimer se je besedilo informacij o zdravilu uskladilo.
Based on the available data, the CHMP is of the opinion that all raised question were adequately addressed and that the harmonised Product Information wording is acceptable.
Na podlagi razpoložljivih podatkov CHMP meni, da so bili na vsa odprta vprašanja predloženi ustrezni odgovori ter da je usklajeno besedilo informacij o zdravilu sprejemljivo.
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
PODLAGA ZA SPREMEMBO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling and
- obseg napotitve je bila uskladitev povzetka glavnih značilnosti zdravil, označevanja in navodila za
package leaflet,
uporabo,
Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
dovoljenj za promet z zdravilom, so bili ovrednoteni na podlagi predložene dokumentacije in strokovne razprave v Odboru,
- the Marketing Authorisation has agreed to the commit to the Conditions of the Marketing Authorisation,
- imetnik dovoljenj za promet z zdravilom soglaša, da bo upošteval pogoje dovoljenja za promet z
the CHMP has recommended the amendment of the Marketing Authorisations for which the Summaries of Product Characteristics, labelling and package leaflet are set out in Annex III for Risperdal and associated names (see Annex I).
je Odbor za zdravila za uporabo v humani medicini priporočil dopolnilo dovoljenj za promet z zdravilom Risperdal in z njim povezanih imen, za katera so v Dodatku III določeni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo (glejte Dodatek I).
The conditions of the Marketing Authorisation are listed in Annex IV.
Pogoji za dovoljenje za promet z zdravilom so navedeni v Dodatku IV.
51 ANNEX III
51 DODATEK III
52 SUMMARY OF PRODUCT CHARACTERISTICS
52 POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
RISPERDAL and associated names (see Annex I) 0.25 mg film-coated tablets [See Annex I – To be completed nationally]
RISPERDAL® in sorodna imena (glejte Dodatek 1) 0, 25 mg filmsko obložene tablete [Glejte Dodatek 1 – poglavje bo dopolnjeno nacionalno]
RISPERDAL and associated names (see Annex I) 0.5 mg film-coated tablets
RISPERDAL® in sorodna imena (glejte Dodatek 1) 0, 5 mg filmsko obložene tablete
RISPERDAL and associated names (see Annex I) 1 mg film-coated tablets
RISPERDAL® in sorodna imena (glejte Dodatek 1) 1 mg filmsko obložene tablete
RISPERDAL and associated names (see Annex I) 2 mg film-coated tablets
RISPERDAL® in sorodna imena (glejte Dodatek 1) 2 mg filmsko obložene tablete
RISPERDAL and associated names (see Annex I) 3 mg film-coated tablets
RISPERDAL® in sorodna imena (glejte Dodatek 1) 3 mg filmsko obložene tablete
RISPERDAL and associated names (see Annex I) 4 mg film-coated tablets
RISPERDAL® in sorodna imena (glejte Dodatek 1) 4 mg filmsko obložene tablete
RISPERDAL and associated names (see Annex I) 6 mg film-coated tablets
RISPERDAL® in sorodna imena (glejte Dodatek 1) 6 mg filmsko obložene tablete
0.5 mg orodispersible tablets
RISPERDAL QUICKLET®in sorodna imena (glejte Dodatek 1) 0, 5 mg orodisperzibilne tablete
1 mg orodispersible tablets
RISPERDAL QUICKLET®in sorodna imena (glejte Dodatek 1) 1 mg orodisperzibilne tablete
2 mg orodispersible tablets
RISPERDAL QUICKLET®in sorodna imena (glejte Dodatek 1) 2 mg orodisperzibilne tablete
3 mg orodispersible tablets
RISPERDAL QUICKLET®in sorodna imena (glejte Dodatek 1) 3 mg orodisperzibilne tablete
4 mg orodispersible tablets
RISPERDAL QUICKLET®in sorodna imena (glejte Dodatek 1) 4 mg orodisperzibilne tablete
RISPERDAL and associated names (see Annex I) 1mg/ ml oral solution
RISPERDAL® in sorodna imena (glejte Dodatek 1) 1 mg/ ml peroralna raztopina
RISPERDAL is indicated for the treatment of schizophrenia.
Zdravilo RISPERDAL se uporablja za zdravljenje shizofrenije.
RISPERDAL is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders.
Zdravilo RISPERDAL se uporablja za zdravljenje zmernih do hudih maničnih epizod, povezanih z bipolarnimi motnjami.
RISPERDAL is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer’ s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others.
Zdravilo RISPERDAL se uporablja za kratkotrajno zdravljenje (do 6 tednov) dolgotrajne agresije pri bolnikih z zmerno do hudo Alzheimerjevo demenco, ki se ne odzivajo na ne- farmakološke ukrepe in pri njih obstaja tveganje za samopoškodovanje ali poškodovanje drugih.
RISPERDAL is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of
54 Zdravilo RISPERDAL se uporablja za kratkotrajno (do 6 tednov) simptomatsko zdravljenje dolgotrajne agresije pri motnjah vedenja pri otrocih starih najmanj 5 let in mladostnikih s podpovprečnimi umskimi sposobnostmi ali duševno manjrazvitimi, diagnosticirano po DSM IV kriterijih, pri katerih agresivno ali drugo razdiralno vedenje zahteva farmakološko zdravljenje.
Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention.
Farmakološko zdravljenje mora biti del celovitega programa, ki vključuje tudi psihosocialne in izobraževalne ukrepe.
It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the treatment of conduct disorder of children and adolescents.
Priporočeno je, da risperidon predpiše specialist nevropediater, pedopsihiater ali zdravnik, ki je dobro seznanjen z zdravljenjem vedenjskih motenj pri otrocih in mladostnikih.
RISPERDAL may be given once daily or twice daily.
Zdravilo RISPERDAL se lahko daje enkrat ali dvakrat na dan.
Patients should start with 2 mg/ day risperidone.
Bolniki naj bi začeli zdravljenje z 2 mg risperidona na dan.
The dosage may be increased on the second day to 4 mg.
Odmerek lahko drugi dan zvišamo na 4 mg.
Subsequently, the dosage can be maintained unchanged, or further individualised, if needed.
Odmerek lahko ostane nespremenjen, ali pa ga po potrebi prilagodimo posameznemu bolniku.
Most patients will benefit from daily doses between 4 and 6 mg.
Običajni optimalni odmerek je 4 do 6 mg na dan.
In some patients, a slower titration phase and a lower starting and maintenance dose may be appropriate.
Pri nekaterih bolnikih je titracijska faza (postopno prilagajanje odmerka) lahko počasnejša in jim zadostuje manjši začetni ter vzdrževalni odmerek.
Doses above 10 mg/ day have not demonstrated superior efficacy to lower doses and may cause increased incidence of extrapyramidal symptoms.
Višji odmerki lahko povzročijo ekstrapiramidne neželene učinke.
Safety of doses above 16 mg/ day has not been evaluated, and are therefore not recommended.
Varnost odmerkov nad 16 mg na dan ni bila preučevana, zato višjih odmerkov ne priporočamo.
A starting dose of 0.5 mg twice daily is recommended.
Priporočeni začetni odmerek je 0, 5 mg dvakrat na dan.
This dosage can be individually adjusted with 0.5 mg twice daily increments to 1 to 2 mg twice daily.
Lahko ga individualno zvišujemo po 0, 5 mg dvakrat na dan do odmerka 1 do 2 mg dvakrat na dan.
Risperidone is not recommended for use in children below age 18 with schizophrenia due to a lack of data on efficacy.
Zaradi pomanjkanja podatkov o učinkovitosti, uporaba risperidona pri otrocih s shizofrenijo pod 18 let ni priporočljiva.
RISPERDAL should be administered on a once daily schedule, starting with 2 mg risperidone.
Zdravilo RISPERDAL se daje enkrat na dan, začetni odmerek je 2 mg risperidona.
Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments of 1 mg per day.
Če je klinično potrebno, lahko odmerek prilagajamo, vendar le v intervalu, ki ni manjši od 24 ur.
Risperidone can be administered in flexible doses over a range of 1 to 6 mg per day to optimize each patient’ s level of efficacy and tolerability.
Za vsakega bolnika se odmerek prilagodi, da se doseže optimalno stopnjo učinkovitosti in primernosti odmerka.
Daily doses over 6 mg risperidone have not been investigated in patients with manic episodes.
Odmerki nad 6 mg na dan, pri bolnikih z bipolarno manijo, niso bili preiskovani.
As with all symptomatic treatments, the continued use of RISPERDAL must be evaluated and justified on an ongoing basis.
Kot pri vseh simptomatskih zdravljenjih, je treba smiselnost nadaljevanja zdravljenja z zdravilom RISPERDAL redno ocenjevati in opravičiti.
Elderly A starting dose of 0.5 mg twice daily is recommended.
Priporočeni začetni odmerek je 0, 5 mg dvakrat na dan.
This dosage can be individually adjusted with 0.5 mg twice daily increments to 1 to 2 mg twice daily.
Lahko ga individualno zvišujemo po 0, 5 mg dvakrat na dan do odmerka 1 mg do 2 mg dvakrat na dan.
Since clinical experience in elderly is limited, caution should be exercised.
Klinične izkušnje pri starejših bolnikih so omejene, zato je potrebna previdnost.
55 Persistent aggression in patients with moderate to severe Alzheimer’ s dementia
55 Pediatrična populacija
A starting dose of 0.25 mg twice daily is recommended.
Priporočeni začetni odmerek je 0, 25 mg dvakrat na dan.
This dosage can be individually adjusted by increments of 0.25 mg twice daily, not more frequently than every other day, if needed.
Odmerek lahko individualno zvišujemo po 0, 25 mg dvakrat dnevno, vendar ne pogosteje kot vsak drugi dan.
The optimum dose is 0.5 mg twice daily for most patients.
Optimalni odmerek za večino bolnikov je 0, 5 mg dvakrat dnevno.
Some patients, however, may benefit from doses up to 1 mg twice daily.
Posamezni bolniki lahko potrebujejo odmerke do 1 mg dvakrat dnevno.
RISPERDAL should not be used more than 6 weeks in patients with persistent aggression in Alzheimer’ s dementia.
Pri dolgotrajno agresivnih bolnikih z Alzheimerjevo demenco se zdravilo RISPERDAL ne sme uporabljati več kot 6 tednov.
During treatment, patients must be evaluated frequently and regularly, and the need for continuing treatment reassessed.
Med zdravljenjem je treba pogosto in redno spremljati bolnike ter ocenjevati korist nadaljevanja zdravljenja.
Conduct disorder
Vedenjske motnje
Children and adolescents from 5 to 18 years of age
Otroci in mladostniki stari 5 do 18 let
For subjects ≥ 50 kg, a starting dose of 0.5 mg once daily is recommended.
Pri osebah s telesno maso ≥ 50 kg je priporočeni začetni odmerek 0, 5 mg enkrat na dan.
This dosage can be individually adjusted by increments of 0.5 mg once daily not more frequently than every other day, if needed.
Če je potrebno odmerek individualno prilagajamo po 0, 5 mg/ dan, ne pogosteje, kot vsak drugi dan.
The optimum dose is 1 mg once daily for most patients.
Pri večini bolnikov je priporočeni odmerek 1 mg/ dan.
Some patients, however, may benefit from 0.5 mg once daily while others may require 1.5 mg once daily.
Pri nekaterih bolnikih je lahko učinkovit že odmerek 0, 5 mg/ dan, pri drugih pa bo morda potreben odmerek 1, 5 mg/ dan.
For subjects < 50 kg, a starting dose of 0.25 mg once daily is recommended.
Pri osebah s telesno maso < 50 kg je priporočeni začetni odmerek 0, 25 mg enkrat na dan.
This dosage can be individually adjusted by increments of 0.25 mg once daily not more frequently than every other day, if needed.
Če je potrebno odmerek individualno prilagajamo po 0, 25 mg/ dan, ne pogosteje, kot vsak drugi dan.
The optimum dose is 0.5 mg once daily for most patients.
Pri večini bolnikov je priporočeni odmerek 0, 5 mg/ dan.
Some patients, however, may benefit from 0.25 mg once daily while others may require 0.75 mg once daily.
Pri nekaterih bolnikih je lahko učinkovit že odmerek 0, 25 mg/ dan, pri drugih pa bo morda potreben odmerek 0, 75 mg/ dan.
RISPERDAL is not recommended in children less than 5 years of age, as there is no experience in children less than 5 years of age with this disorder.
Z zdravljenjem vedenjskih motenj pri otrocih, mlajših od 5 let, ni dovolj izkušenj, zato uporaba zdravila RISPERDAL ni priporočljiva.
Renal and hepatic impairment
Bolniki z ledvično in jetrno okvaro
Patients with renal impairment have less ability to eliminate the active antipsychotic fraction than in adults with normal renal function.
Bolniki z ledvično okvaro imajo zmanjšano sposobnost izločanja aktivne antipsihotične frakcije v primerjavi z odraslimi z normalnim delovanjem ledvic.
Patients with impaired hepatic function have increases in plasma concentration of the free fraction of risperidone.
Bolniki z jetrno okvaro imajo zvišano plazemsko koncentracijo proste frakcije risperidona.
Irrespective of the indication, starting and consecutive dosing should be halved, and dose titration should be slower for patients with renal or hepatic impairment.
Pri bolnikih z ledvično in jetrno okvaro, naj bosta začetni in vzdrževalni odmerek, ne glede na indikacijo, zmanjšana na polovico in titriranje odmerka naj bo upočasnjeno.
RISPERDAL should be used with caution in these groups of patients.
Pri uporabi zdravila RISPERDAL v tej skupini bolnikov moramo biti previdni.
RISPERDAL is for oral use.
Zdravilo RISPERDAL je namenjeno peroralni uporabi.
Food does not affect the absorption of RISPERDAL.
Hrana ne vpliva na absorpcijo zdravila RISPERDAL.
Upon discontinuation, gradual withdrawal is advised.
Priporočljivo je postopno ukinjanje.
Acute withdrawal symptoms, including nausea, vomiting, sweating, and insomnia have very rarely been described after abrupt cessation of high doses of antipsychotic medicines (see section 4.8).
Po nenadni ukinitvi visokih odmerkov antipsihotikov so zelo redko poročali o akutnih odtegnitvenih simptomih, vključno s slabostjo, bruhanjem, potenjem in nespečnostjo
Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported.
Poročali so tudi o gibalnih motnjah (kot so akatizija, distonija in diskinezija).
56 Switching from other antipsychotics.
Prehod z drugih antipsihotikov
When medically appropriate, gradual discontinuation of the previous treatment while RISPERDAL therapy is initiated is recommended.
Kadar je medicinsko utemeljeno, zdravilo RISPERDAL uvajamo ob sočasnem zniževanju predhodnega antipsihotičnega zdravila.
Also, if medically appropriate, when switching patients from depot antipsychotics, initiate RISPERDAL therapy in place of the next scheduled injection.
Kadar prehajamo iz depo antipsihotika, če je to medicinsko utemeljeno, začnemo zdravljenje z zdravilom RISPERDAL v času naslednje predvidene injekcije.
The need for continuing existing anti-Parkinson medicines should be re-evaluated periodically.
Občasno moramo preveriti, ali je potrebno nadaljevati obstoječe zdravljenje z antiparkinsoniki.
RISPERDAL orodispersible tablets:
RISPERDAL orodisperzibilne tablete:
Do not open the blister until ready to administer.
Pretisnega omota ne odpirajte, razen tik pred uporabo.
Do not push the tablet through the foil because it may break.
Ko jemljete tablete iz ovojnine, jih ne potisnite skozi folijo iz pretisnega omota, ampak najprej odstranite folijo na hrbtni strani pretisnega omota.
Remove the tablet from the blister with dry hands.
Tableto vzemite iz pretisnega omota s suhimi rokami.
Immediately place the tablet on the tongue.
Tableto takoj položite na jezik.
The tablet will begin disintegrating within seconds.
Tableta v ustih v nekaj sekundah razpade.
Water may be used if desired.
Če je potrebno se jo lahko pogoltne s tekočino.
RISPERDAL oral solution:
RISPERDAL peroralna raztopina:
For instructions on handling RISPERDAL oral solution see section 6.6.
Za navodila za uporabo zdravila Risperdal peroralna raztopina glejte poglavje 6. 6.
Hypersensitivity to the active substance or to any of the excipients.
Znana preobčutljivost za risperidon ali katerokoli pomožno snov.
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 RISPERDAL.
Pri starejših bolnikih z demenco, ki se zdravijo z atipičnimi antipsihotiki, so v meta- analizi 17 nadzorovanih preskušanj z atipičnimi antipsihotičnimi zdravili, vključno z zdravilom RISPERDAL, ugotovili povečano pojavnost smrtnosti v primerjavi s placebom.
In placebo-controlled trials with 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 4, 0% pri bolnikih zdravljenih s peroralno obliko zdravila RISPERDAL v primerjavi s 3, 1% v skupini, ki je prejemala placebo.
In the 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).
The increase in mortality in patients treated with furosemide plus risperidone was observed in two of the four clinical trials.
Povečano smrtnost so ugotovili v dveh od štirih opravljenih kliničnih preskušanj.
Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings.
Sočasna uporaba z drugimi diuretiki (v glavnem s tiazidnimi diuretiki v majhnih odmerkih) ni bila povezana s podobnimi ugotovitvami.
No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed.
57 Nobenega patofiziološkega mehanizma, niti vzorca o vzrokih smrtnosti, niso opazili.