qanastek/EMEA-V3 huggingface dataset:
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 Disruptive Behaviour disorder of children and adolescents .”
Huwa rakkomandat li risperidone jiġi preskritt minn speċjalista fin - newroloġija tat- tfal u l- psikjatrija tat- tfal u l- adolexxenti jew tobba li jkunu familjari sewwa mat - trattament tad- disturb tal- Imġiba li jikkawża Diżintegrazzjoni tal- imġieba tat- tfal u l- adolexxenti. ”
For section 4.2, the CHMP revised the wording stating that risperidone should not be recommended for use in children/ adolescents under 18 years of age with schizophrenia or with bipolar mania, due to a lack of systematic efficacy/ safety and clinical data for this age group.
Għas- sezzjoni 4. 2, is- CHMP irreveda l- kitba li ssostni li risperidone ma għandux jiġi rakkomandat għall- użu fi tfal/ adolexxenti ta ’ inqas minn 18- il sena bi skizofrenija jew b’ manija bipolari, minħabba n- nuqqas ta ’ informazzjoni sistematika klinika u dwar l- effikaċja/ sigurtà għal dan il- grupp tal- età.
For section 4.4, the CHMP implemented a revised wording for the hyperprolactinaemia section, excluding specific mention of prolactinoma and breast cancer, as although data supporting a possible relationship between hyperprolactinaemia and risk of some prolactin-dependent tumours exists, the data is still largely inconclusive from a clinical perspective.
Għas- sezzjoni 4. 4, is- CHMP implimenta kitba riveduta għas- sezzjoni dwar l- iperprolaktinemija, li teskludi t- tismija speċifika tal- prolaktinoma u l- kanċer tas- sider, billi għalkemm teżisti informazzjoni li ssostni relazzjoni possibbli bejn l- iperprolaktinemija u r- riskju ta ’ xi tumuri dipendenti fuq il - prolaktina, din l- informazzjoni għadha fil- parti l- kbira inkonklussiva minn perspettiva klinika.
A statement was included in section 4.4 on the risk in elderly patients with dementia treated concomitantly with furosemide and risperidone.
F’ sezzjoni 4. 4 ġiet inkluża dikjarazzjoni dwar ir- riskju f’ pazjenti anzjani bid- dimenzja li jiġu ttrattati simultanjament b’ furosemide u risperidone.
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.
Is- CHMP implimenta wkoll għadd ta ’ reviżjonijiet fis - subsezzjoni dwar it- tfal u l- adolexxenti, b’ mod partikolari fir- rigward tas- sedazzjoni u ż- żieda klinikament sinifikanti fil- piż.
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.
Għas- sezzjoni 4. 5, is- CHMP evalwa u armonizza l- kitba dwar l- interazzjonijiet ma ’ prodotti mediċinali oħra, fejn iddiskuta b’ mod partikolari t- torsades de pointes, prodotti li jimpedixxu l - metaboliżmu epatiku ta ’ risperidone, it- taħlita ma ’ sustanzi oħra li jaġixxu ċentralment minħabba r - riskju akbar ta ’ sedazzjoni u l- agonisti tad- dopamina.
The CHMP also deleted the mention of haloperidol, discussed interaction with verapamil and revised the wording on plasma concentrations.
Is- CHMP ħassar ukoll ir- referenza għall - haloperidol, iddiskuta l- interazzjoni ma ’ verapamil u rreveda l- kitba dwar il- konċentrazzjonijiet fil - plażma.
The CHMP also inserted texts on the interaction of risperidone with food.
Is- CHMP daħħal ukoll kitbiet dwar l- interazzjoni ta ’ risperidone mal- ikel.
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.
Għas- sezzjoni 4. 8, is- CHMP evalwa u rreveda kompletament il- kitba tal- SPC, billi kkunsidra episodji avversi ġodda u ssikka s- sezzjoni billi rreveda r- raggruppament tat- termini tal- effetti avversi.
Left and right bundle branch block were grouped together but sedation and somnolence, and anxiety and nervousness were ungrouped.
Il - blokok tax- xellug u tal- lemin ġew miġburin flimkien iżda s- sedazzjoni u n- ngħas, u l- ansjetà u n -
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.
Is- CHMP iddeċieda li ma jiġborx is- sintomi ekstrapiramidali fit - tabella tas- sezzjoni 4. 8 iżda rreveda n- nota ta ’ qiegħ il- paġna li tirreferi għall- marda ta ’ Parkinson rispettivament ekstrapiramidali fis- sezzjoni 4. 8 u daħħal nota ta ’ qiegħ il- paġna għall - iperprolaktinemija.
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).
Bħala Kundizzjoni tal- Awtorizzazzjoni għat- Tqegħid fis- Suq, is- CHMP talab lill- MAH jimpenja ruħu biex jipproduċi ġabra ta ’ informazzjoni fuq perjodu fit- tul għall- evalwazzjoni tas- sigurtà ta ’ risperidone fuq perjodu fit- tul fi tfal u adolexxenti b’ disturb tal- imġiba għal dak li għandu x’ jaqsam mal- effetti potenzjali fuq it- tkabbir (tul u piż), l- iżvilupp mentali, u l- maturazzjoni sesswali (skont l - istadju Tanner).
The study should also assess prolactin values and possible prolactin-related AEs.
L- istudju għandu jevalwa wkoll il- valuri tal- prolaktina u l- effetti avversi possibbli relatati mal- prolaktina.
Regarding cognitive assessment, the MAH should make a proposal as to how it would be possible to assess effects on cognitive development.
Dwar l- evalwazzjoni konoxxittiva, l- MAH għandu jagħmel proposta dwar kif ikunu jistgħu jiġu evalwati l- effetti fuq l- iżvilupp konoxxittiv.
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.
Is- CHMP evalwa l- proposta tal- MAH li jwettaq studju retrospettiv ieħor tal- grupp ibbażat fuq ir - rekords mediċi disponibbli, li fihom tkun disponibbli informazzjoni dwar il- preskrizzjoni kif ukoll dwar l- istadji Tanner u t- tkabbir.
As the treatment duration is now limited, the CHMP did not consider a prospective long-term study to be required.
Billi t- tul tat- trattament issa huwa limitat, is- CHMP ma ħassx li hemm bżonn ta ’ studju prospettiv fuq perjodu fit- tul.
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.
Fl- aħħar nett, is- CHMP innota li l- pipetti tas- soluzzjoni orali Risperdal ġew aġġornati fl- 2007 biex jinkludu l- gradazzjoni għal kull 0. 25 mg b’ disinni differenti skont id- daqs tal- pipetta.
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.
Saru għadd ta ’ reviżjonijiet fl- SPC u dawn ir- reviżjonijiet ġew implimentati kif dovut fit- tikketti u l- fuljett ta ’ tagħrif.
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.
Is- sezzjonijiet kollha tal- SPC ġew evalwati bir- reqqa u r- reviżjonijiet kollha ġew implimentati kif dovut fit- Tikketti u fil- Fuljett ta ’ Tagħrif, sabiex inkiseb test armonizzat ta ’ Informazzjoni dwar il- Prodott.
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.
Abbażi tal- informazzjoni disponibbli, is- CHMP iħoss li l- mistoqsijiet kollha li tqajmu ġew indirizzati adegwatament u li l- kitba armonizzata tal- Informazzjoni dwar il- Prodott hija aċċettabbli.
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
RAĠUNIJIET GĦALL- EMENDA TAS- SOMMARJU TAL- KARATTERISTIĊI TAL - PRODOTT, IT- TIKKETTI U L- FULJETT TA ’ TAGĦRIF
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling and
- l- għan tar- referenza kien l- armonizzazzjoni tas- Sommarji tal- Karatteristiċi tal- Prodotti, tat- tikketti u
package leaflet,
tal- fuljett ta ’ tagħrif,
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing
- is- Sommarji tal- Karatteristiċi tal- Prodott, it- tikketti u l- fuljett tat- tagħrif proposti mid- Detenturi tal -
- the Marketing Authorisation has agreed to the commit to the Conditions of the Marketing Authorisation,
- l- Awtorizzazzjoni għat- Tqegħid fis- Suq qablet mal- impenn li jiġu osservati l- Kundizzjonijiet tal -
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).
is- CHMP irrakkomanda l- emenda tal- Awtorizzazzjonijiet għat- Tqegħid fis- Suq li s- Sommarji tal - Karatteristiċi tal- Prodotti, it- tikketti u l- fuljett ta ’ tagħrif għalihom huma stipulati f’ Anness III, għal Risperdal u l- ismijiet assoċjati (ara Anness I).
The conditions of the Marketing Authorisation are listed in Annex IV.
Il- kundizzjonijiet tal- Awtorizzazzjoni għat- Tqegħid fis - Suq huma elenkati f’ Anness IV.
51 ANNEX III
55 ANNESS III
52 SUMMARY OF PRODUCT CHARACTERISTICS
56 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
RISPERDAL and associated names (see Annex I) 0.25 mg film-coated tablets [See Annex I – To be completed nationally]
RISPERDAL u ismijiet assoċjati miegħu (ara Anness 1) 0. 25 mg pilloli miksijin b’ rita [Ara Anness I – Biex timtela mill- pajjiż partikolari]
RISPERDAL and associated names (see Annex I) 0.5 mg film-coated tablets
RISPERDAL u ismijiet assoċjati miegħu (ara Anness 1) 0. 5 mg pilloli miksijin b’ rita
RISPERDAL and associated names (see Annex I) 1 mg film-coated tablets
RISPERDAL u ismijiet assoċjati miegħu (ara Anness 1) 1 mg pilloli miksijin b’ rita
RISPERDAL and associated names (see Annex I) 2 mg film-coated tablets
RISPERDAL u ismijiet assoċjati miegħu (ara Anness 1) 2 mg pilloli miksijin b’ rita
RISPERDAL and associated names (see Annex I) 3 mg film-coated tablets
RISPERDAL u ismijiet assoċjati miegħu (ara Anness 1) 3 mg pilloli miksijin b’ rita
RISPERDAL and associated names (see Annex I) 4 mg film-coated tablets
RISPERDAL u ismijiet assoċjati miegħu (ara Anness 1) 4 mg pilloli miksijin b’ rita
RISPERDAL and associated names (see Annex I) 6 mg film-coated tablets
RISPERDAL u ismijiet assoċjati miegħu (ara Anness 1) 6 mg pilloli miksijin b’ rita
RISPERDAL Quicklet and associated names (see Annex I):
RISPERDAL Quicklet u ismijiet assoċjati miegħu (ara Anness 1):
0.5 mg orodispersible tablets
0. 5 mg pilloli li jinħallu fil- ħalq
1 mg orodispersible tablets
1 mg pilloli li jinħallu fil- ħalq
2 mg orodispersible tablets
2 mg pilloli li jinħallu fil- ħalq
3 mg orodispersible tablets
3 mg pilloli li jinħallu fil- ħalq
4 mg orodispersible tablets
4 mg pilloli li jinħallu fil- ħalq
RISPERDAL and associated names (see Annex I) 1mg/ ml oral solution
RISPERDAL u ismijiet assoċjati miegħu (ara Anness 1) 1 mg/ ml soluzzjoni orali
RISPERDAL is indicated for the treatment of schizophrenia.
RISPERDAL huwa indikat għall- kura ta ’ l- iskizofrenja
RISPERDAL is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders.
RISPERDAL huwa indikat għall- kura ta ’ episodji ta ’ manija moderati sa qawwija assoċjati ma ’ disturbi bipolari.
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.
RISPERDAL huwa indikat għal perjodu qasir ta ’ kura (sa 6 ġimgħat) ta ’ agressjoni persistenti f’ pazjenti bid- dimenzja ta ’ Alzheimer moderata sa qawwija li ma tirrispondix għal modi ta ’ kura mhux farmakoloġiċi u meta jkun hemm riskju ta ’ ħsara għal persuna nnifisha u għal persuni oħra.
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
RISPERDAL huwa indikat għal perjodu qasir ta ’ kura tas- sintomi (sa 6 ġimgħat) ta ’ aggressjoni persistenti ta ’ disturb fl- imġiba fi tfal mill- età ta ’ 5 snin u adoloxxenti, b’ funzjoni intellettwali anqas mill- medja jew lura fl- iżvilupp mentali b’ dijanjosi skond il- kriterji DSM- IV li f’ dawn l- individwi l -
54 aggressive or other disruptive behaviours require pharmacologic treatment.
58 qawwa ta ’ komportamenti aggressivi u komportamenti diżordnati oħra jeħtieġu kura farmakoloġika.
Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention.
Kura farmakoloġika għandha tkun parti integrali minn programm ta ’ kura aktar komprensiv, inkluż intervent psikosoċjali u edukattiv.
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.
Huwa rrakkomandat li risperidone jkun preskritt minn speċjalist fin- newroloġija tat- tfal u fil- psikjatrija tat- tfal u l- adoloxxenti jew minn tobba li jafu sewwa l- kura ta ’ distrurbi ta ’ imġiba fit- tfal u l- adoloxxenti.
Schizophrenia
Skizofrenja
RISPERDAL may be given once daily or twice daily.
RISPERDAL jista ’ jingħata darba jew darbtejn kuljum.
Patients should start with 2 mg/ day risperidone.
Il- pazjenti għandhom jibdew b’ 2 mg/ jum risperidone.
The dosage may be increased on the second day to 4 mg.
Id- dożaġġ jista ’ jiżdied fit- tieni jum għal 4mg.
Subsequently, the dosage can be maintained unchanged, or further individualised, if needed.
Wara dan, id- doża tista ’ tkun mantenuta mingħajr tibdil, jew tiġi individwalizzata aktar jekk meħtieġ.
Most patients will benefit from daily doses between 4 and 6 mg.
Il- biċċa l- kbira tal- pazjenti jibbenefikaw minn dożi ta ’ kuljum bejn l- 4 u s- 6 mg.
In some patients, a slower titration phase and a lower starting and maintenance dose may be appropriate.
F’ xi wħud mill - pazjenti, fażi aktar bil- mod ta ’ titrazzjoni u doża tal- bidu u ta ’ manteniment aktar baxxi jistgħu jkunu xierqa.
Doses above 10 mg/ day have not demonstrated superior efficacy to lower doses and may cause increased incidence of extrapyramidal symptoms.
Dożi aktar minn 10 mg/ jum ma wrewx effikaċja superjuri għal dożi aktar baxxi u jistgħu jikkawżaw inċidenza ogħla ta ’ sintomi ekstrapramidali.
Safety of doses above 16 mg/ day has not been evaluated, and are therefore not recommended.
Is- sigurtà tad- dożi aktar minn 16 mg/ jum ma ġewx evalwati, u għalhekk m’ humiex rakkommandati.
A starting dose of 0.5 mg twice daily is recommended.
Anzjani Doża tal- bidu ta ’ 0. 5 mg darbtejn kuljum hija rakkomandata.
This dosage can be individually adjusted with 0.5 mg twice daily increments to 1 to 2 mg twice daily.
Dan id- dożaġġ jista ’ jiġi aġġustat b’ żidiet ta ’ 0. 5 mg darbtejn kuljum għal 1sa 2mg darbtejn kuljum.
Risperidone is not recommended for use in children below age 18 with schizophrenia due to a lack of data on efficacy.
Tfal Risperidone m’ huwiex rakkomandat għall- użu fi tfal taħt it- 18- il sena bi skizofrenja minħabba nuqqas ta ’ tagħrif dwar l- effikaċja.
Manic episodes in bipolar disorder
Episodji ta ’ Manija f’ Disturb Bipolari
RISPERDAL should be administered on a once daily schedule, starting with 2 mg risperidone.
RISPERDAL għandu jingħata fuq skeda ta ’ darba kuljum, li tibda minn 2 mg ta ’ risperidone.
Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments of 1 mg per day.
Aġġustamenti tad- doża, jekk indikati, għandhom isiru f’ intervalli ta ’ mhux anqas minn 24 siegħa u f’ żieda ta ’ dożaġġ ta ’ 1mg kuljum.
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.
Risperidone jista ’ jingħata f’ dożi flessibbli fuq medda ta ’ bejn 1 u 6 mg kuljum biex isir l- aħjar użu mill- livell ta ’ effikaċja u tollerabilità ta ’ kull pazjent.
Daily doses over 6 mg risperidone have not been investigated in patients with manic episodes.
Dożi ta ’ aktar minn 6mg risperidone kuljum ma ġewx investigati f’ pazjenti b’ episodji manijaċi.
As with all symptomatic treatments, the continued use of RISPERDAL must be evaluated and justified on an ongoing basis.
Bħal kull kura tas- sintomi, il- kontinwazzjoni ta ’ l- użu ta ’ RISPERDAL għandu jiġi evalwat u ġġustifikat regolarment.
Elderly A starting dose of 0.5 mg twice daily is recommended.
Anzjani Doża tal- bidu ta ’ 0. 5 mg darbtejn kuljum hija rakkomandata.
This dosage can be individually adjusted with 0.5 mg twice daily increments to 1 to 2 mg twice daily.
Dan id- dożaġġ jista ’ jiġi aġġustat b’ mod individwali b’ żidiet ta ’ 0. 5 mg darbtejn kuljum sa 1 mg għal 2 mg darbtejn kuljum.
Since clinical experience in elderly is limited, caution should be exercised.
Minħabba li l - esperjenza klinika fl- anzjani hija limitata, għandha tintuża attenzjoni.
Paediatric population
Tfal
Risperidone is not recommended for use in children below age 18 with bipolar mania due to a lack of data on efficacy.
Risperidone m’ huwiex rakkomandat għall- użu fi tfal taħt it- 18- il sena b’ manija bipolari minħabba nuqqas ta ’ tagħrif dwar l- effikaċja.
55 Persistent aggression in patients with moderate to severe Alzheimer’ s dementia
59 Aggressjoni Persistenti f’ Pazjenti bid- Dimenzja ta ’ Alzheimer Moderata sa Qawwija
A starting dose of 0.25 mg twice daily is recommended.
Doża tal- bidu ta ’ 0. 25 mg darbtejn kuljum hija rakkomandata.
This dosage can be individually adjusted by increments of 0.25 mg twice daily, not more frequently than every other day, if needed.
Dan id- dożaġġ jista ’ jiġi aġġustat individwalment b’ żidiet ta ’ 0. 25 mg darbtejn kuljum, mhux aktar frekwenti minn kull jumejn, jekk meħtieġ.
The optimum dose is 0.5 mg twice daily for most patients.
L- aħjar doża hija ta ’ 0. 5 mg darbtejn kuljum għal biċċa l- kbira tal- pazjenti.
Some patients, however, may benefit from doses up to 1 mg twice daily.
Xi pazjenti, madankollu, jistgħu jibbenefikaw minn dożi sa 1 mg darbtejn kuljum.
RISPERDAL should not be used more than 6 weeks in patients with persistent aggression in Alzheimer’ s dementia.
RISPERDAL m’ għandux jintuża għal aktar minn 6 ġimgħat f’ pazjenti b’ aggressjoni persistenti fid - dimenzja ta ’ Alzheimer.
During treatment, patients must be evaluated frequently and regularly, and the need for continuing treatment reassessed.
Waqt il- kura, il- pazjenti għandhom jiġu evalwati frekwentement u regolarment, u l- bżonn li jitkompla it- trattament għandu jiġi stmat mill- ġdid.
Conduct disorder
Disturbi fl- Imġiba
Children and adolescents from 5 to 18 years of age
Dan id- dożaġġ jista ’ jkun aġġustat individwalment b’ żidiet ta ’ 0. 5 mg darba kuljum mhux aktar frekwenti minn kull jumejn, jekk meħtieġ.
For subjects ≥ 50 kg, a starting dose of 0.5 mg once daily is recommended.
L- aħjar doża hija ta ’ 1mg darba kuljum għal biċċa l- kbira tal- pazjenti.
The optimum dose is 1 mg once daily for most patients.
Xi pazjenti, madankollu, jistgħu jibbenefikaw minn 0. 5 mg darba kuljum filwaqt li oħrajn jista ’ jkollhom bżonn ta ’ 1. 5 mg darba kuljum.
For subjects < 50 kg, a starting dose of 0.25 mg once daily is recommended.
Għal individwi < 50 kg, doża tal- bidu ta ’ 0. 25 mg hija rakkommandata.
This dosage can be individually adjusted by increments of 0.25 mg once daily not more frequently than every other day, if needed.
Dan id- dożaġġ jista ’ jkun aġġustat individwalment b’ żidiet ta ’ 0. 25 mg darba kuljum mhux aktar frekwenti minn kull jumejn, jekk meħtieġ.
The optimum dose is 0.5 mg once daily for most patients.
L- aħjar doża hija ta ’ 0. 5 mg darba kuljum għal biċċa l- kbira tal- pazjenti.
Some patients, however, may benefit from 0.25 mg once daily while others may require 0.75 mg once daily.
Xi pazjenti, madankollu, jistgħu jibbenefikaw minn 0. 25 mg darba kuljum filwaqt li oħrajn jista ’ jkollhom bżonn ta ’ 0. 75 mg darba kuljum.
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.
RISPERDAL m’ huwiex rakkommandat fi tfal ta ’ età anqas minn 5 snin, minħabba li m’ hemm l- ebda esperjenza fi tfal ta ’ taħt il- 5 snin b’ dan id- disturb.
Renal and hepatic impairment
Indeboliment Renali u Epatiku
Patients with renal impairment have less ability to eliminate the active antipsychotic fraction than in adults with normal renal function.
Pazjenti b’ indebolimet renali għandhom abilità anqas li jneħħu l- porzjon antipsikotiku attiv minn persuni adulti b’ funzjoni normali tal- kliewi.
Patients with impaired hepatic function have increases in plasma concentration of the free fraction of risperidone.
Pazjenti b’ indeboliment tal- funzjoni epatika jkollhom żieda fil- konċentrazzjoni tal- porzjon ta ’ risperidone liberu fil- plażma.
Irrespective of the indication, starting and consecutive dosing should be halved, and dose titration should be slower for patients with renal or hepatic impairment.
Irrispettivament mill- indikazzjoni, id- doża tal- bidu u d- dożar konsekuttiv għandu jitnaqqas bin- nofs, u t- titrazzjoni tad- doża għandha ssir aktar bil- mod għall- pazjenti b’ indeboliment renali jew epatiku.
RISPERDAL should be used with caution in these groups of patients.
RISPERDAL għandu jintuża b’ attenzjoni f’ dawn il- gruppi ta ’ pazjenti.
RISPERDAL is for oral use.
RISPERDAL qiegħed għall- użu mill- ħalq.
Food does not affect the absorption of RISPERDAL.
L- ikel ma jaffettwax l- assorbiment ta ’ RISPERDAL.
Upon discontinuation, gradual withdrawal is advised.
Meta ma ’ jitkompliex, huwa rakkommandat li jinqatgħa bil- mod il- mod.
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).
Sintomi akuti ta ’ waqfien mill- kura, inkluż dardir, rimettar, għaraq, u insomnja ġew deskritti b’ mod rari wara waqfien f’ daqqa waħda ta ’ dożi qawwija ta ’ mediċini antipsikotiċi (ara sezzjoni 4. 8).
Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported.
Li sintomi psikjatriċi jerġgħu jitfaċċaw mill- ġdid tista ’ wkoll isseħħ, u kien irrappuratat li jitfaċċaw disturbi ta ’ movimenti involontarji (bħal akathisia, distonja u diskajneżja).
56 Switching from other antipsychotics.
Meta taqleb minn antipsikotiċi oħrajn.
When medically appropriate, gradual discontinuation of the previous treatment while RISPERDAL therapy is initiated is recommended.
Meta xieraq b’ mod mediku, huwa rakkommandat li l- kura ta ’ qabel tinqata ’ bil- mod il- mod filwqat li tinbeda kura b’ RISPERDAL.
Also, if medically appropriate, when switching patients from depot antipsychotics, initiate RISPERDAL therapy in place of the next scheduled injection.
60 antipsikotiċi depot, ibda RISPERDAL minflok l- injezzjoni skedata li jkun imiss.
The need for continuing existing anti-Parkinson medicines should be re-evaluated periodically.
Il- bżonn li jitkomplew mediċini eżistenti ta ’ kontra l- Parkinson għandu jiġi evalwat mill- ġdid perjodikament.
RISPERDAL orodispersible tablets:
RISPERDAL pilloli li jinħallu fil- ħalq:
Do not open the blister until ready to administer.
Tiftaħx il- folja qabel ma ’ tkun lesta biex tingħata.
Peel open the blister to expose the tablet.
Iftaħ il- folja billi tqaxxarha biex tikxef il- pillola.
Do not push the tablet through the foil because it may break.
Timbuttax il- pillola minn ġol- fojl għax tista titfarrak.
Remove the tablet from the blister with dry hands.
Neħħi il- pillola mill- folja b’ idejn niexfin.
Immediately place the tablet on the tongue.
Mill- ewwel poġġi l- pillola fuq l- ilsien.
The tablet will begin disintegrating within seconds.
Il- pillola tibda tiddiżintegra fi ftit sekondi.
Water may be used if desired.
Jista ’ jintuża l- ilma jekk ikun mixtieq.
RISPERDAL oral solution:
RISPERDAL soluzzjoni orali:
For instructions on handling RISPERDAL oral solution see section 6.6.
Għall- istruzzjonijiet ta ’ kif timmaniġġja RISPERDAL soluzzjoni orali ara sezzjoni 6. 6
Hypersensitivity to the active substance or to any of the excipients.
Sensittività eċċessiva magħrufa għas- sustanza attiva jew għal xi waħda mis- sustanzi mhux attivi.
Elderly patients with dementia
Pazjenti Anzjani bid- Dimenzja
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.
Pazjenti anzjani bid- dimenzja kkurati b’ antipsikotiċi atipiċi għandhom żieda fil- mortalità meta mqabbla ma ’ plaċebo f’ meta- analiżi ta ’ 17- il prova kkontrollata ta ’ antipsikotiċi atipiċi li jinkludu RISPERDAL.
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.
Fi provi kliniċi kkontrollati bi plaċebo b’ RISPERDAL f’ din il- popolazzjoni, l - inċidenza ta ’ mortalità kienet ta ’ 4. 0% għall- pazjenti kkurati b’ RISPERDAL meta mqabbla ma ’ 3. 1% għall- pazjenti kkurati bil- plaċebo.
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).
Fil- provi kkontrollati bi plaċebo ta ’ RISPERDAL f’ pazjenti anzjani bid- dimenzja, inċidenza ogħla ta ’ mortalità kienet osservata f’ pazjenti kkurati b’ furosemide u risperidone (7. 3%; età medja 89 sena, medda 75- 97) meta mqabbla ma ’ pazjenti kkurati b’ risperidone waħdu (3. 1%; età medja 84, medda 70- 96) jew furosemide waħdu (4. 1%; età medja 80 sena, medda 67- 90).
The increase in mortality in patients treated with furosemide plus risperidone was observed in two of the four clinical trials.
Iż- żieda fil- mortalità fil - pazjenti kkurati b’ furosemide u risperidone kienet ossevata fi tnejn mill- erba ’ provi kliniċi.
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.
Madankollu, għandu jkun hemm attenzjoni u r - riskji u l- benefiċċji ta ’ dawn it- tnejn flimkien jew ta ’ trattament flimkien ma ’ dijuretiċi qawwija oħra għandhom ikunu kkunsidrati qabel ma tittieħed id- deċiżjoni li jintużaw.
There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment with risperidone.
Ma kienx hemm żieda fl - inċidenza ta ’ mortalità fost pazjenti li kienu qed jieħdu diuretiċi oħrajn bħala trattament flimkien ma ’ risperidone.
57 Cerebrovascular Adverse Events (CVAE)
Każi avversi ċerebrovaskulari (CVAE)
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).
61 iskemiku għaddieni f’ pazjenti kkurati b’ RISPERDAL meta mqabbla ma ’ pazjenti kkurati bi plaċebo (età medja 85 sena; medda 73 sa 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.
Id- dejta pooled minn sitt studji kkontrollati bi plaċebo f’ pazjenti li l- maggoranza tagħhom kienu anzjani (età > 65 sena) bid- dimenzja urew li CVAEs (serji u mhux serji, flimkien) seħħew f’ 3. 3% (33/ 1009) tal- pazjenti kkurati b’ risperidone u f’ 1. 2% (8/ 712) tal - pazjenti kkurati bi plaċebo.
The odds ratio (95% exact confidence interval) was 2.96 (1.34, 7.50).
Il- porzjon ta ’ probabbilità (95% intervall ta ’ kunfidenza eżatta) kien 2. 96 (1. 34, 7. 50).
The mechanism for this increased risk is not known.
Il- mekkaniżmu għal din iż- żieda fir- riskju m’ huwiex magħruf.
An increased risk cannot be excluded for other antipsychotics or other patient populations.
Żieda fir- riskju ma tistax tiġi eskluża għal antipsikotiċi oħra jew popolazzjonijiet ta ’ pazjenti oħra.
RISPERDAL should be used with caution in patients with risk factors for stroke.
RISPERDAL għandu jintuża b’ attenzjoni f’ pazjenti b’ fatturi ta ’ riskju għal puplesija.
The risk of CVAEs was significantly higher in patients with mixed or vascular type of dementia when compared to Alzheimer’ s dementia.
Ir- riskju ta ’ CVAEs kien sinifikament ogħla f’ pazjenti b’ dimenzja tat- tip imħallta jew vaskulari meta mqabbel ma ’ dimenzja ta ’ Alzheimer.
Therefore, patients with other types of dementias than Alzheimer’ s should not be treated with risperidone.
Għalhekk, pazjenti b’ tipi oħra ta ’ dimenzja minbarra dik ta ’ Alzheimer m’ għandhiex tiġi kkurata b’ risperidone.
Physicians are advised to assess the risks and benefits of the use of RISPERDAL in elderly patients with dementia, taking into account risk predictors for stroke in the individual patient.
It- tobba għandhom ikunu mgħarrfa biex jistmaw ir- riskji u l- benefiċċji ta ’ l- użu ta ’ RISPERDAL f’ pazjenti anzjani bid- dimenzja, u jikkunsidraw dak li jipprevedi riskju ta ’ pulesija fil- pazjent individwali.
Patients/ caregivers should be cautioned to immediately report signs and symptoms of potential CVAEs such as sudden weakness or numbness in the face, arms or legs, and speech or vision problems.
Pazjenti / persuni li jieħdu ħsiebhom għandhom ikunu mwissija biex jirrappurtaw immedjatament sinjali u sintomi li jistgħu ikunu ta ’ CVAEs bħal dgħjufija u tirżiħ f’ daqqa fil- wiċċ, fid- dirgħajn jew fis- saqajn, u problemi bil- kliem u bil- vista.
All treatment options should be considered without delay, including discontinuation of risperidone.
Kull għażla ta ’ kura possibbli għandha tiġi kkunsidrata mingħajr dewmien inkluż waqfien mill- kura b’ risperidone.
RISPERDAL should only be used short term for persistent aggression in patients with moderate to severe Alzheimer’ s dementia to supplement non-pharmacological approaches which have had limited or no efficacy and when there is potential risk of harm to self or others.
RISPERDAL għandu jintuża biss għal perjodu qasir għal aggressjoni persistenti f’ pazjenti bid - dimenzja moderata sa qawwija ta ’ Alzheimer biex jissupplimenta modi mhux farmakoloġiċi li għandhom effikaċja limitata jew m’ għandhomx effikaċja u meta jkun hemm potenzjalment riskju ta ’ ħsara għal persuna nnifisha u għal persuni oħra.
Patients should be reassessed regularly, and the need for continuing treatment reassessed.
Pazjenti għandhom jiġu valutati mill- ġdid regolarment, u l- bżonn li titkompla l- kura jiġi stmat mill - ġdid.
Orthostatic hypotension
Pressjoni Baxxa Ortostatika
Due to the alpha-blocking activity of risperidone, (orthostatic) hypotension can occur, especially during the initial dose-titration period.
Minħabba l- attività ta ’ risperidone li jimblokka r- riċetturi alfa, pressjoni baxxa (ortostatika) tista ’ sseħħ, speċjalment waqt il- perjodu tal- bidu ta ’ titrazzjoni tad- doża.
Clinically significant hypotension has been observed postmarketing with concomitant use of risperidone and antihypertensive treatment.
Pressjoni baxxa klinikament sinifikanti kienet osservata wara t- tqegħid fis- suq bl- użu ta ’ risperidone flimkien ma ’ kura kontra l - pressjoni għolja.
RISPERDAL should be used with caution in patients with known cardiovascular disease (e. g., heart failure, myocardial infarction, conduction abnormalities, dehydration, hypovolemia, or cerebrovascular disease), and the dosage should be gradually titrated as recommended (see section 4.2).
RISPERDAL għandu jintuża b’ attenzjoni f’ pazjenti li huma magħrufa li għandhom mard tal- qalb (eż. insuffiċjenza tal- qalb, infart mijokardijaku, anormalitajiet tal- konduzzjoni, deidratazzjoni, ipovolemija, jew mard ċerebrovaskulari), u d- dożaġġ għandu jiġi titrat bil- mod il- mod kif rakkommandat (ara sezzjoni 4. 2).
A dose reduction should be considered if hypotension occurs.
Tnaqqis fid- doża għandu jiġi kkunsidrat jekk ikun hemm pressjoni baxxa mal- waqfien.
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.
Mediċini li għandhom kwalitajiet antagonistiċi għar- riċetturi dopamine ġew assoċjati ma l- induzzjoni ta ’ diskajniżja tardiva ikkaratterizzata minn movimenti ritmiċi involuntarji, l- aktar predominanti fl - ilsien u/ jew il- wiċċ.
Neuroleptic Malignant Syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels has been reported to occur with antipsychotics.
Is- Sindrome Newrolettiku Malinn, ikkaratterizzat minn ipertermja, ebusija fil- muskoli, instabbilità awtonomika, livell mibdul ta ’ koxjenza u livelli ta ’ creatine phosphokinase elevati ġew irrappurtati li jseħħu b’ antipsikotiċi.
In this event, all antipsychotics, including RISPERDAL, should be discontinued.
F’ dan il- każ, l- antipsikotiċi kollha, inkluż RISPERDAL għandhom jitwaqqfu.
58 Parkinson’ s disease and dementia with Lewy bodies
62 Marda ta ’ Parkinson u Dimenzja bil- Korpi Lewy
Parkinson’ s Disease may worsen with risperidone.
It- tobba għandhom iqisu r- riskji u l- benefiċċji meta jagħtu antipsikotiċi, inkluż RISPERDAL, lill - pazjenti bil- Marda ta ’ Parkinson jew Dimenzja bil- Korpi Lewy (DLB) il- Marda ta ’ Parkinson tista ’ tmur għall- agħar b’ risperidone.
Both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotic medicinal products; these patients were excluded from clinical trials.
Iż- żewġ gruppi jista ’ jkollhom riskju ogħla tas- Sindrome Newrolettiku Malinn kif ukoll sensittività akbar għall- prodotti mediċinali antipsikotiċi; dawn il- pazjenti ġew esklużi mill- provi kliniċi.
Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Manifestazzjoni ta ’ din is- sensittività ogħla tista ’ tinkludi konfużjoni, tmewwit, instabbilità li twassal għal waqgħat frekwenti, flimkien ma ’ sintomi ekstrapiramidali.
Hyperglycemia or exacerbation of pre-existing diabetes has been reported in very rare cases during treatment with RISPERDAL.
Ipergliċemija jew taħrix ta ’ dijabete li diġa ’ teżisti kienet irrappurtata f’ każi rari ħafna waqt kura b’ RISPERDAL.
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 relevant medical history.
Studji fuq kolturi ta ’ tessuti jissuġġerixxu li t- tkabbir taċ- ċelluli f’ tumuri tas- sider uman jistgħu jkunu stimulati mill- prolactin. Għalkemm l- ebda assoċjazzjoni ċara bl- għoti ta ’ antipsikotiċi ma ntweriet sa issa fi studji kliniċi u epidemjoloġiċi, hija rakkomandata attenzjoni f’ pazjenti bi storja medika rilevanti.
RISPERDAL should be used with caution in patients with pre-existing hyperprolactinaemia and in patients with possible prolactin-dependent tumours.
RISPERDAL għandu jintuża b’ attenzjoni f’ pazjenti b’ iperprolaktinimja li diġà teżisti u f’ pazjenti li jista ’ jkun li għandhom tumuri dipendenti mill- prolactin.
QT prolongation
QT Imtawwal
QT prolongation has very rarely been reported postmarketing.
Kien rari ħafna li żieda fil- QT kienet irrapurtata wara t- tqegħid fis- suq.
As with other antipsychotics, caution should be exercised when risperidone is prescribed in patients with known cardiovascular disease, family history of QT prolongation, bradycardia, or electrolyte disturbances (hypokalaemia, hypomagnesaemia), as it may increase the risk of arrhythmogenic effects, and in concomitant use with medicines known to prolong the QT interval.
Bħal fil- każ ta ’ antipsikotiċi oħra, irid ikun hemm attenzjoni meta risperidone jingħata lil pazjenti li huma magħrufa li għandhom mard kardjovaskulari jew passat mediku fil- familja ta ’ żieda fil- QT, bradikardja, jew disturbi fl - elettroliti (ipokalimja, ipomagnesimja), minħabba li jista ’ jkabbar ir- riskju ta ’ effetti arritmoġeniċi, u meta jintuża flimkien ma ’ mediċini magħrufa li jtawwlu l- intervall QT.
RISPERDAL should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
RISPERDAL għandu jintuża b’ attenzjoni f’ pazjenti b’ passat ta ’ aċċessjonijiet jew kundizzjonijiet oħra li għandhom il- potenzjal li jkabbru l- possibiltà ta ’ aċċessjoni.
Priapism
Priapiżmu
Priapism may occur with RISPERDAL treatment due to its alpha-adrenergic blocking effects.
Priapiżmu jista ’ jseħħ bil- kura ta ’ RISPERDAL minħabba l- effetti tiegħu li jimblokka r- riċetturi adrenerġiċi alfa.
Appropriate care is advised when prescribing RISPERDAL to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e. g., exercising strenuously, exposure to extreme heat, receiving concomitant treatment with anticholinergic activity, or being subject to dehydration.
Għandha ssir attenzjoni xierqa meta RISPERDAL jinkiteb lil pazjenti li jistgħu jkunu f’ kundizzjonijiet li jistgħu jikkontribwixxu għal żieda fit- temperatura tal- qalba tal- ġisem, eż., eżerċizzju qawwi, esponiment għal sħana estrema, it- teħid tiegħu ma ’ trattament b’ attività antikolinerġika, jew li tkun suġġett għal deidratazzjoni.
Children and adolescents
63 Tfal u Adoloxxenti
Before risperidone is prescribed to a child or adolescent with conduct disorder they should be fully assessed for physical and social causes of the aggressive behaviour such as pain or inappropriate environmental demands.
Qabel jinkiteb risperidone lil xi tifel/ tifla jew adoloxxent b’ disturb fl- imġieba huma għandha ssirilhom stima sħiħa tal- kawżi fiżiċi u soċjali tal- komportament agressiv bħal ma huma uġigħ jew ħtiġijiet ambjentali mhux xierqa.
59 The sedative effect of risperidone should be closely monitored in this population because of possible consequences on learning ability.
L- effett sedattiv ta ’ risperidone għandu jiġi mmonitorjat mill- qrib f’ din il- popolazzjoni minħabba konsegwenzi li jista ’ jkun hemm fuq l- abbiltà tat- tagħlim.
A change in the time of administration of risperidone could improve the impact of the sedation on attention faculties of children and adolescents.
Bidla fil- ħin li fih jingħata risperidone jista ’ jtejjeb l- impatt tas- sedazzjoni fuq il- kapaċitajiet ta ’ l- attenzjoni tat- tfal u l- adoloxxenti.
Risperidone was associated with mean increases in body weight and body mass index (BMI).
Risperidone kien assoċjat ma ’ żieda medja fil- piż tal- ġisem u fl- Indici tal- Massa tal- Ġisem (BMI).
Changes in height in the long-term open-label extension studies were within expected age-appropriate norms.
Bidliet fit- tul tal- persuna fi studji ta ’ estensjoni open- label li jieħdu fit- tul kienu kif mistennija skond l- età.
The effect of long-term risperidone treatment on sexual maturation and height have not been adequately studied.
L- effetti ta ’ kura fit- tul b’ risperidone fuq l- iżvilupp sesswali u t- tul tal- ġisem ma ġewx studjati b’ mod suffiċjenti.
Because of the potential effects of prolonged hyperprolactinemia on growth and sexual maturation in children and adolescents, regular clinical evaluation of endocrinological status should be considered, including measurements of height, weight, sexual maturation, monitoring of menstrual functioning, and other potential prolactin-related effects.
Minħabba l- effetti li jista ’ jkun hemm ta ’ l- iperprolaktinimja għal- tul ta ’ żmien fuq l- iżvilupp tal - ġisem u l- iżvilupp sesswali fit- tfal u l- adoloxxenti, evalwazzjoni regolari klinika ta ’ l- istat endokrinoloġiku għandu jiġi kkunsidrat, u għandu jinkludi kejl ta ’ tul, piż, maturità sesswali, monitoraġġ tal- funzjoni menstruwali u effetti oħra li jista ’ jkollhom x’ jaqsmu mal- prolactin.
During treatment with risperidone regular examination for extrapyramidal symptoms and other movement disorders should also be conducted.
Waqt il- kura b’ risperidone eżami regolari għal sintomi ekstrapiramidali u disturbi oħra tal- moviment għandhom isiru wkoll.
For specific posology recommendations in children and adolescents see Section 4.2.
Għal rakkomandazzjonijiet ta ’ pożoloġija speċifiċi fit- tfal u l- adolexxenti ara Sezzjoni 4. 2.
The film-coated tablets contain lactose.
Il- pilloli miksijin b’ rita fihom lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għall - galattożju, d- defiċjenza ta ’ Lapp lactase jew malassorbiment tal- glukożju- galattożju m’ għandhomx jieħdu din il- mediċina.
(pertains only to the film-coated tablets)
(dan japplika biss għall- pilloli miksijin b’ rita)
The orodispersible tablets contain aspartame.
Il- pilloli li jinħallu fil- ħalq fihom l- aspartame.
Aspartame is a source of phenylalanine which may be harmful for people with phenylketonuria.
Aspartame huwa sors ta ’ phenylalanine li jista ’ jkun ta ’ ħsara għal- persuni b’ phenylketonuria.
(pertains only to the orodispersible tablets)
(dan japplika biss għall- pilloli li jinħallu fil- ħalq)
Contains sunset yellow (E110).
Fih sunset yellow (E110).
May cause allergic reactions.
Jista ’ jikkawża reazzjonijiet allerġiċi.
(pertains only to the 2mg and 6 mg film-coated tablets)
(japplika biss għall- pilloli taż- 2 mg u tas- 6 mg miksijin b’ rita)
As with other antipsychotics, caution is advised when prescribing risperidone with medicinal products known to prolong the QT interval, e. g., class Ia antiarrhythmics (e. g., quinidine, dysopiramide, procainamide), class III antiarrhythmics (e. g., amiodarone, sotalol), tricyclic antidepressant (i. e., amitriptyline), tetracyclic antidepressants (i. e., maprotiline), some antihistaminics, other antipsychotics, some antimalarials (i. e., chinice and mefloquine), and with medicines causing electrolyte imbalance (hypokalaemia, hypomagnesiaemia), bradycardia, or those which inhibit the hepatic metabolism of risperidone.
Bħal b’ antipsikotiċi oħrajn, attenzjoni hija rakkomandata meta risperidone jiġi preskritt flimkien ma ’ prodotti mediċinali magħrufa li jtawwlu l- intervall QT, eż., antiarritmiċi tal- klassi Ia (eż., quinidine, dysopiramide, procainamide), antiarritmiċi tal- klassi III (eż., amiodarone, sotalol), antidepressant triċikliku (i. e., amitriptylene), antidepressanti tetraċikliċi (i. e., maprotilene), xi anti- istaminiċi, antipsikotiċi oħrajn, xi mediċini kontra l- malarja (i. e., chinice u mefloquine), u ma ’ mediċini oħra li jikkawżaw żbilanċ fl- elettroliti (ipokalimja, ipomagnesimja), bradikardija, jew dawk li jimpedixxu l - metaboliżmu epatiku ta ’ risperidone.
Potential for RISPERDAL to affect other medicinal products
Il- potenzjal ta ’ RISPERDAL li jaffettwa prodotti mediċinali oħra
Risperidone should be used with caution in combination with other centrally-acting substances notably including alcohol, opiates, antihistamines and benzodiazepines due to the increased risk of sedation.
Risperidone għandu jintuża b’ attenzjoni flimkien ma ’ sustanzi oħra b’ azzjoni ċentrali l- aktar jinkludu l- alkoħol, opiates, antistaminiċi, u benzodiazepines minħabba żieda fir- riskju ta ’ sedazzjoni.
RISPERDAL may antagonise the effect of levodopa and other dopamine agonists.
RISPERDAL jista ’ jantagonizza l- effett ta ’ levodopa u agonisti tad- dopamine oħrajn.
If this combination is deemed necessary, particularly in end-stage Parkinson’ s disease, the lowest effective dose of each treatment should be prescribed.
Jekk din it - taħlita ta ’ mediċini hija meqjusa bħala meħtieġa, b’ mod partikolari fl- aħħar stadju tal- marda ta ’ Parkinson, l- inqas doża ta ’ kull kura, li hija effettiva, għandha tiġi preskritta.
Clinically significant hypotension has been observed postmarketing with concomitant use of risperidone and antihypertensive treatment.
64 Pressjoni baxxa klinikament sinifikanti kienet osservata wara t- tqegħid fis- suq bl- użu ta ’ risperidone flimkien ma ’ kura kontra l- pressjoni għolja.
60 Potential for other medicinal products to affect RISPERDAL
Il- potenzjal ta ’ prodotti mediċinali oħra li jaffettwaw RISPERDAL
Similar effects may be observed with e. g. rifampicin, phenytoin and phenobarbital which also induce CYP 3A4 hepatic enzyme as well as P-glycoprotein.
Effetti jixxiebhu jistgħu jiġu osservati b’ eż. rifampicin, phenytoin u phenobarbital li wkoll jinduċu l- enzima epatika CYP 3A4 kif ukoll il- glikoproteina- P.
When carbamazepine or other CYP 3A4 hepatic enzyme/ P-glycoprotein (P-gp) inducers are initiated or discontinued, the physician should re-evaluate the dosing of RISPERDAL.
Meta carbamazepine jew xi indutturi oħra ta ’ l- enzima epatika CYP 3A4/ glikoproteina- P (P- gp) jinbdew jew jitwaqqfu, it- tabib għandu jevalwa mill- ġdid id- dożaġġ ta ’ RISPERDAL.
It is expected that other CYP 2D6 inhibitors, such as quinidine, may affect the plasma concentrations of risperidone in a similar way.
Huwa mistenni li impedituri oħra ta ’ CYP 2D6, bħal quinidine, jistgħu jaffettwaw il- konċentrazzjonijiet ta ’ risperidone fil- plażma b’ mod jixxiebah.
When concomitant fluoxetine or paroxetine is initiated or discontinued, the physician should re-evaluate the dosing of RISPERDAL.
Meta fluoxetine jew paroxetine mogħtija flimkien ma ’ risperidone jinbdew jew jitwaqqfu, it- tabib għandu jevalwa mill- ġdid id- dożaġġ ta ’ RISPERDAL.
Verapamil, an inhibitor of CYP 3A4 and P-gp, increases the plasma concentration of risperidone.
Verapamil, impeditur ta ’ CYP 3A4 u P- gp, iżid il- konċentrazzjoni ta ’ risperidone fil- plażma.
Phenothiazines, tricyclic antidepressants, and some beta-blockers may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction.
Phenothiazines, antidipressanti triċikliċi, u xi imblokkaturi tar- riċetturi beta jistgħu jżidu l - konċentrazzjonijiet ta ’ risperidone fil- plażma iżda mhux dawk tal- porzjon antipsikotiku attiv.
Amitriptyline does not affect the pharmacokinetics of risperidone or the active antipsychotic fraction.
Amitriptyline ma jaffettwax il- farmakokinetika ta’ risperidone jew il- porzjon antipsikotiku attiv.
Cimetidine and ranitidine increase the bioavailability of risperidone, but only marginally that of the active antipsychotic fraction.
Cimetidine u ranitidine jżidu l- biodisponibbiltà ta’ risperidone, iżda jżidu biss bi ftit dak tal- porzjon antipsikotiku attiv.
The combined use of psychostimulants (e. g., methylphenidate) with RISPERDAL in children and adolescents did not alter the pharmacokinetics and efficacy of RISPERDAL.
L- użu ta ’ psikostimulanti (eż. methylphenidate) flimkien ma ’ RISPERDAL fit- tfal u l- adoloxxenti ma bidilx il- farmakokinetika u l- effikaċja ta ’ RISPERDAL.
Concomitant use of oral RISPERDAL with paliperidone is not recommended as paliperidone is the active metabolite of risperidone and the combination of the two may lead to additive active antipsychotic fraction exposure.
L- użu orali ta ’ RISPERDAL flimkien ma ’ paliperidone m’ huwiex rakkommandat minħabba li paliperidone huwa sustanza attiva ffurmata mill- metaboliżmu ta ’ risperidone u t- teħid tagħhom it - tnejn flimkien jista ’ jwassal għal esponiment addittiv mal- porzjon antipsikotiku attiv.