qanastek/EMEA-V3 huggingface dataset:
Relatively constant dose-response after Risperdal Consta treatment using doses from 25 to 75 mg is considered to be established and the CHMP agreed that good medical practice would be to start patients at the lowest effective dose and to increase the dose only if the response is insufficient.
Doża- reazzjoni relattivament kostanti wara kura b’ Risperdal Consta bl- użu ta ’ dożi minn 25 sa 75 mg hija kkunsidrata stabbilita u s- CHMP qabel li prattika medika tajba tkun li l- pazjenti jinbdew fuq l- iktar doża baxxa effettiva u li d- doża tiżdied biss jekk ir- reazzjoni ma tkunx biżżejjed.
This was supported by results from the switching studies and since this product has been on the market for several years already, its efficacy and safety have been already confirmed.
Dan kien appoġġjat minn riżultati mill- istudji ta ’ qlib u peress li dan il- prodott diġà ilu fis- suq għal bosta snin, l- effikaċja u s- sigurtà diġà ġew ikkonfermati.
The CHMP was also of the opinion that the proposed wording of the SPC gives enough flexibility to the treating physician to start with the dose of 25 mg or higher.
Is- CHMP kien ukoll ta ’ l- opinjoni li l- formolazzjoni tal - kliem proposta fl- SPC tagħti biżżejjed flessibilità lit- tabib li jkun qiegħed jagħti l- kura biex jibda b’ doża ta ’ 25 mg jew b’ doża ogħla.
Regarding the precise correspondence of an oral risperidone dose to a specific dose of Risperdal Consta, a wording in the SPC was adopted, reflecting the available efficacy and safety data and the results of clinical studies, to guide the choice of starting dose of Risperdal Consta:
Rigward il- korrispondenza preċiża ta ’ doża orali ta ’ risperidone għal doża speċifika ta ’ Risperdal Consta, ġiet adottata formolazzjoni fl- SPC, li tirrifletti tagħrif dwar l- effikaċja u s- sigurtà disponibbli u r- riżultati ta ’ studji kliniċi, biex tiggwida l- għażla ta ’ doża tal- bidu ta ’ Risperdal Consta:
“ For most patients the recommended dose is 25 mg intramuscular every two weeks.
“ Għall- maġġoranza tal- pazjenti, id- doża rrakkomandata hija ta ’ 25 mg intramuskolari kull ġimagħtejn.
For those patients on a fixed dose of oral risperidone for two weeks or more, the following conversion scheme should be considered.
Għal dawk il- pazjenti fuq doża fissa ta ’ risperidone orali għal ġimagħtejn jew iktar, għandha tiġi kkunsidrata l- iskema ta ’ konverżjoni li ġejja.
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.
Pazjenti kkurati b’ dożaġġ ta ’ 4 mg risperidone orali jew inqas għandhom jirċievu 25 mg Risperdal Consta, waqt li pazjenti kkurati b’ dożi orali ogħla għandhom ikunu kkunsidrati għad- doża ogħla ta ’ 37. 5 mg ta ’ 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.
Meta attwalment, il- pazjenti ma jkunux qegħdin jieħdu risperidone orali, id- dożaġġ orali ta ’ qabel il - bidu tal- kura għandu jkun ikkunsidrat meta tkun qegħda tintagħżel id- doża i. m. tal- bidu.
The recommended starting dose is 25 mg Risperdal Consta every two weeks.
Id- dożaġġ tal- bidu rrakkomandat huwa 25 mg Risperdal Consta kull ġimagħtejn.
Patients on higher dosages of the used oral antipsychotic should be considered for the higher Risperdal Consta dose of 37.5 mg .”
Pazjenti fuq dożaġġi iktar għoljin ta ’ l- antipsikotiku orali wżat għandhom ikunu kkunsidrati għad- doża ogħla ta ’ 37. 5 mg ta ’ 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.
Is- CHMP ivvaluta ukoll l- iddożar propost ta ’ 12. 5 mg, b’ mod partikolari fir- rigward tal- popolazzjoni anzjana, u kkunsidra li doża ta ’ 12. 5 mg ta ’ Risperdal Consta tipprovdi flessibilità addizzjonali ta ’ l - iddożar iżda enfassizza li din id- doża hija biss intenzjonata bħala doża inizjali iktar baxxa biex tistabbilixxi t- tollerabbilità, biex tintuża prinċipalment f’ pazjenti b’ sensittività ogħla għall- effetti tal - mediċina, jew minħabba metaboliżmu/ eliminazzjoni mnaqqsin, jew f’ pazjenti b’ tollerabbilità intrinsika iktar baxxa għall- medikazzjoni psikotropika.
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”.
Dan kien rifless fil- formolazzjoni tal- kliem armonizzata tal- SPC, flimkien mad- dikjarazzjoni “ L- effikaċja tad- doża ta ’ 12. 5 mg ma ġietx investigata fi provi kliniċi ”.
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.
Barra minn hekk, il- PK ta ’ Risperdal Consta fil- popolazzjoni anzjana kien deskritt adegwatement, u intwera li l- farmakokinetiċi fil- popolazzjoni > 65 sena huma komparabbli mal- popolazzjoni < 65 sena.
Due to the known efficacy and safety profile of risperidone, this additional dose is approvable without its own efficacy data and can be based solely on the PK data.
Minħabba l- profil ta ’ l- effikaċja u s- sigurtà magħruf ta ’ risperidone, din id- doża addizjonali hija approvabbli mingħajr it- tagħrif ta ’ l- effikaċja tagħha u tista ’ tkun biss ibbażata fuq it- tagħrif tal- PK.
The CHMP assessed the need for a warning, advising against the use of Risperdal Consta in acute exacerbations of schizophrenia, but considered it to potentially raise a safety concern that is not valid or clinically justified and that there are no particular risks associated with using Risperdal Consta in acute exacerbations of schizophrenia that warrant a warning.
Is- CHMP ivvaluta l- ħtieġa għal twissija, li tagħti parir kontra l- użu ta ’ Risperdal Consta f’ taħrixiet akuti ta ’ skiżofrenija, iżda ikkunsidraha li potenzjalment tista ’ tqajjem tħassib dwar is- sigurtà li mhuwiex validu jew klinikament iġġustifikat u li ma hemm l- ebda riskju partikolari assoċjat ma ’ l- użu ta ’ Risperdal Consta f’ taħrixiet akuti ta ’ skiżofrenija li jistħoqilhom twissija.
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.
Jekk Risperdal Consta jintuża f’ konformità mar- rakkomandazzjonijiet tal- SPC għall- iddożar, ma huwa mbassar l- ebda riskju għas- sigurtà jew l- effikaċja għall- pazjent, anke jekk il- pazjent ikun marid b’ mod akut.
The CHMP adopted the following text in section 4.2:
Is- CHMP adotta t- test li ġej fis- sezzjoni 4. 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 .”
“ Risperdal Consta m’ għandux jintuża f’ taħrixijiet akuti ta ’ skiżofrenija mingħajr ma tkun assigurata kopertura antipsikotika biżżejjed b’ risperidone orali jew bl- antipsikotiku preċedenti matul il- perijodu ta ’ differenza ta ’ tliet ġimgħat wara l- ewwel injezzjoni ta ’ 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.
17 Finalment, is- CHMP iddiskuta l- użu ta ’ Risperdal Consta f’ pazjenti kkurati preċedentament b’ risperidone orali f’ dożi ta ’ ≥6mg/ kuljum u nnota li t- tagħrif dwar l- effikaċja pprovdut ta ’ dawn il - pazjenti, meta maqlubin għal fuq Risperdal Consta, ma kienx differenti mit- tagħrif miksub wara l - kura preċedenti b’ risperidone orali, minkejja l- probabbilità għolja li jintlaħaq livell iktar baxx ta ’ risperidone fil- plażma.
In addition, long-acting risperidone offers an advantage in increased compliance to the treatment, which could result in more stable plasma levels of risperidone.
Barra minn hekk, risperidone li jaħdem fit- tul joffri vantaġġ f’ konformità mal - kura, li jista ’ jirriżulta f’ livelli iktar stabbli ta ’ risperidone fil- plażma.
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.
Is- CHMP kien ukoll ta ’ l - opinjoni li dożi ta ’ risperidone > 8 mg/ kuljum m’ għandhomx jintużaw bħala rutina u għandhom ikunu ristretti għal ċerti grupp ta ’ pazjenti.
In conclusion, the CHMP was not in favour of restricting the use of long-acting risperidone for patients who were administered with 6 mg risperidone per day.
Bħala konklużjoni, is- CHMP ma kienx favur li jirristrinġi l- użu ta ’ risperidone li jaħdem fit- tul għall- pazjenti li ngħataw 6 mg risperidone kuljum.
The CHMP assessed the data provided on the use of Risperdal Consta in elderly patients and was of the opinion that no significant trend of increased adverse events according to the age of patients or dose of Risperdal Consta were identified.
Is- CHMP ivvaluta t- tagħrif ipprovdut fuq l- użu ta ’ Risperdal Consta f’ pazjenti anzjani u kien ta ’ l - opinjoni li l- ebda tendenza sinifikanti ta ’ żieda fl- episodji avversi skond l- età tal- pazjenti jew doża ta ’ Risperdal Consta ma kienet identifikata.
All differences were accordingly justified and the proposed wording in the SPC is acceptable.
Id- differenzi kollha kienu għaldaqstant iġġustifikati u l - formolazzjoni ta ’ kliem proposta fl- SPC hija aċċettabbli.
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.
Il- MAH ippreżenta tabella li tiġbor fil- qosor ir- riżultati ta ’ skor totali ta ’ PANSS minn RIS- INT- 61, imqassam b’ livell ta ’ doża għall- gruppi ta ’ doża ta ’ 25 mg, 50 mg u 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.
Żewġ tabelli addizjonali pprovdew dejta li turi li l- kura mhijiex inferjuri għall- kura orali b’ risperidone għall- bidliet fis- sottoskali ta ’ sintomi pożittivi u negattivi ta ’ PANSS.
The CHMP considered that the requested efficacy analysis had been provided and that the efficacy of Risperdal Consta was shown in all doses separately.
Is- CHMP ikkunsidra li l- analiżi ta ’ l- effikaċja mitluba kienet ingħatat u l- effikaċja ta ’ Risperdal Consta intweriet fid- dożi kollha separatament.
For section 4.3, the CHMP discussed the relevance of a Contraindication warning for patients with high risk factors for cerebrovasular adverse events.
Fis- sezzjoni 4. 3, is- CHMP iddiskuta r- relevanza ta ’ twissija ta ’ Kontraindikazzjoni għall- pazjenti b’ fatturi ta ’ riskju għoljin għal episodji ċerebrovaskulari avversi.
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.
Minħabba li Risperdal Consta ma ġiex studjat f’ pazjenti anzjani bid- dimenzja, għaldaqstant mhuwiex indikat f’ dan il- grupp ta ’ pazjenti, kif iddikjarat fis- Sezzjoni 4. 4 tal- SPC propost u b’ mod konformi mal- linja gwida tal- SPC attwali tas - CHMP.
The CHMP agreed that the presence of cerebrovascular risk factors is poorly predictive for a risperidone-mediated increased cerebrovascular risk and was therefore of the opinion that a contraindication for Risperdal Consta in patients with high risk factors for cerebrovascular events was not justified.
Is- CHMP qabel li l- preżenza ta ’ fatturi ta ’ riskju ċerebrovaskulari ftit li xejn tiswa għat - tbassir għal żieda fir- riskju ċerebrovaskulari medjat minn risperidone u għaldaqstant kien ta ’ l - opinjoni li kontraindikazzjoni għal Risperdal Consta f’ pazjenti b’ fatturi ta ’ riskju għoljin għall - episodji ċerebrovaskulari ma kinitx iġġustifikata.
For section 4.4, the CHMP implemented the wording on tardive dyskinesia, agreed upon by the Pharmacovigilance Working Party.
Għal sezzjoni 4. 4, is- CHMP implimenta l- formolazzjoni ta ’ kliem fuq diżkajniżja tardiva, li qabel magħha l- Grupp ta ’ Ħidma dwar il- Farmakoviġilanza.
The CHMP further assessed the need for special mention of hyperprolactinaemia and stimulation of cell growth in breast tumours linked to prolactin.
Is- CHMP ivvaluta iktar il- ħtieġa għal aċċenn speċjali fuq iperprolaktinimja u stimulazzjoni ta ’ żvilupp ta ’ ċelloli f’ tumuri tas- sider relatati ma ’ prolaktin.
The CHMP considered the MAH responses and agreed that although data may suggest that prolactin is involved in breast cancer etiology, further studies are required to establish a formal link, and therefore adopted the following wording, addressing the potential risks of hyperprolactinaemia, although without specific inclusion of prolactinoma and breast cancer:
Is- CHMP ikkunsidra r- reazzjonijiet tal- MAH u aċċetta li għalkemm it- tagħrif jista ’ jissuġġerixxi li prolaktin huwa involut fl- etjoloġija ta ’ kanċer tas- sider, jeħtieġu iktar studji biex jistabbilixxu relazzjoni formali, u għaldaqstant adottaw il- formolazzjoni tal- kliem li ġejja, li tindirizza r- riskji potenzjali ta ’ iperprolaktinimja, għalkemm mingħajr inklużjoni speċifika ta ’ prolaktinoma u kanċer tas- sider:
“ Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
“ Studji ta ’ kultura tat- tessut jissuġġerixxu li żvilupp ta ’ ċelloli f’ tumuri tas- sider umani jistgħu jkunu stimulati permezz ta ’ prolaktin.
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.
Għalkemm s’ issa ma ntweriet l- ebda assoċjazzjoni ċara bl- għoti ta ’ antipsikotiċi fi studji kliniċi u epidemjoloġiċi, hija rrakkomandata l- kawtela f’ pazjenti bi storja medika relevanti.
Risperdal should be used with caution in patients with pre-existing hyperprolactinaemia and in patients with possibly prolactin-dependent tumours .”
Risperdal għandu jintuża bil- kawtela f’ pazjenti b’ iperprolaktinimja pre- eżistenti u f’ pazjenti b’ tumuri possibbilment dipendenti fuq prolaktin. ”
For section 4.6, the CHMP discussed the wording, moving the mention of galactorrhea to section 4.8 and adopting the following harmonised wording:
Għal sezzjoni 4. 6, is- CHMP iddiskuta l- formolazzjoni tal- kliem u ressaq l- aċċenn għal galaktorreja għal sezzjoni 4. 8 u adotta l- kitba armonizzata li ġejja:
“ It has been demonstrated that risperidone and 9-hydroxy-risperidone are also excreted in human breast-milk in small quantities.
“ Intwera li risperidone u 9- hydroxy- risperidone huma wkoll eliminati fil- ħalib tas- sider uman fi kwantitajiet żgħar.
There are no data available on adverse effects in breast-feeding infants.
Ma hemm l- ebda tagħrif disponibbli fuq l- effetti avversi fi trabi li jkunu qegħdin jerdgħu.
Therefore, the advantage of breast-feeding should be weighed against the potential risks for the child .”
Għaldaqstant, il- vantaġġ tat- treddigħ għandu jkun peżat kontra r- riskji potenzjali għat - tarbija. ”
For section 4.8, the CHMP assessed and harmonised the wording.
Għal sezzjoni 4. 8, is- CHMP ivvaluta u armonizza l- formolazzjoni.
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”.
Is- CHMP qabel b’ mod prominenti fuq il- ġabra proposta ta ’ termini ta ’ episodji avversi, iżda madankollu kkunsidra li “ bundle branch block xellugi ” m’ għandhux ikun separat minn “ bundle block lemini ” peress li ġestjoni klinika differenti mhijiex essenzjali. “ Sedazzjoni ” għandha tkun separata minn “ sonnolenza ” u ma għandhiex
Furthermore, « Anxiety » and « nervousness » should be separated and not grouped by the term “ anxiety”.
Barra minn hekk, « Ansjetà » u « nervożiżmu » għandhom ikunu separati u mhux raggruppati bit- terminu “ ansjetà ”.
Finally, « Extrapyramidal symptoms » should be the grouped term in the subparagraph Nervous System Disorders and the single symptoms should be mentioned with an
Finalment, « Sintomi ekstrapiramidali » għandu jkun it- terminu raggruppat fis- sottoparagrafu Disturbi tas- Sistema Nervuża u s- sintomi singoli għandhom ikunu aċċennati b’ asteriks.
As already mentioned, hypersalivation/ drooling should be added to « EPS » as otherwise incidence of EPS is underestimated.
Kif diġà aċċennat, salivazzjoni eċċessiva/ tliegħib għandu jiżdied ma ’ « EPS » għax inkella l- inċidenza ta ’ EPS ma tkunx ivvalutata b’ mod korrett.
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 kienu vvalutati bir- reqqa u r- reviżjonijiet kollha ġew implimentati bix - xieraq fit- Tikketta u l- Fuljett ta ’ Tagħrif, biex b’ hekk inħoloq test armonizzat għall- Fuljett ta ’ Tagħrif.
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 tat- tagħrif disponibbli, is- CHMP huwa ta ’ l- opinjoni li l- kwistjonijiet kollha mqajjma ġew indirizzati b’ mod adegwat u li l- formolazzjoni tal- kliem armonizzata fuq il- Fuljett ta ’ Tagħrif hija aċċettabbli.
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
RAĠUNIJIET GĦALL- EMENDA TAS- SOMMARJI TAL- KARATTERISTIĊI TAL - PRODOTT, TIKKETTA U FULJETT TA ’ TAGĦRIF
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
- l- iskop tar- riferenza kien l- armonizzazzjoni tas- Sommarji tal- Karatteristiċi tal- Prodotti, it- tikketta u
labelling and package leaflet,
l- fuljett ta ’ tagħrif,
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing
- is- Sommarji tal- Karatteristiċi tal- Prodotti, it- tikketta u l- fuljett ta ’ tagħrif proposti mid- Detenturi ta ’
Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
l- Awtorizzazzjoni għat- Tqegħid fis- Suq kienu vvalutati abbażi tad- dokumentazzjoni sottomessa u d - diskussjoni xjentifika fi ħdan il- Kumitat,
the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Risperdal Consta and associated names (see Annex I).
is- CHMP rrakkomanda l- emenda ta ’ l- Awtorizzazzjonijiet għat- Tqegħid fis- Suq għal Risperdal Consta u ismijiet assoċjati (ara Anness I) li s- Sommarji tal- Karatteristiċi tal- Prodott, it- Tikketta u l - Fuljett ta ’ Tagħrif għalihom huma stabbiliti fl- Anness III.
19 SUMMARY OF PRODUCT CHARACTERISTICS
19 ANNESS III
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 u ismijiet assoċjati miegħu (ara Anness I) 12. 5 mg trab u solvent għal suspensjoni li jerħi l- mediċina bil- mod għall- injezzjoni ġol- muskolu [Ara Anness I – Biex timtela mill- pajjiż partikolari]
RISPERDAL CONSTA and associated names (see Annex I) 25 mg powder and solvent for prolonged- release suspension for intramuscular injection
RISPERDAL CONSTA u ismijiet assoċjati miegħu (ara Anness I) 25 mg trab u solvent għal suspensjoni li jerħi l- mediċina bil- mod għall- injezzjoni ġol- muskolu
RISPERDAL CONSTA and associated names (see Annex I) 37.5 mg powder and solvent for prolonged-release suspension for intramuscular injection
RISPERDAL CONSTA u ismijiet assoċjati miegħu (ara Anness I) 37. 5 mg trab u solvent għal suspensjoni li jerħi l- mediċina bil- mod għall- injezzjoni ġol- muskolu
RISPERDAL CONSTA and associated names (see Annex I) 50 mg powder and solvent for prolonged- release suspension for intramuscular injection
RISPERDAL CONSTA u ismijiet assoċjati miegħu (ara Anness I) 50 mg trab u solvent għal suspensjoni li jerħi l- mediċina bil- mod għall- injezzjoni ġol- muskolu
PHARMACEUTICAL FORM
GĦAMLA FARMAĊEWETIKA
RISPERDAL CONSTA is indicated for the maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics.
RISPERDAL CONSTA huwa indikat għall- manteniment ta ’ kura ta ’ skizofrenja f’ pazjenti li bħalissa huma stabilizzati b’ antipsikotiċi mill- ħalq.
Adults Starting dose:
Doża tal- bidu:
For most patients the recommended dose is 25 mg intramuscular every two weeks.
Għal biċċa l- kbira tal- pazjenti d- doża rakkommandata hija ta ’ 25 mg ġol- muskolu kull ġimgħatejn.
For those patients on a fixed dose of oral risperidone for two weeks or more, the following conversion scheme should be considered.
Għal dawk il- pazjenti fuq doża fissa ta ’ risperidone mill- ħalq għal ġimgħatejn jew aktar, l- iskema ta ’ konverżjoni li ġejja għandha tiġi kkunsidrata.
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.
Pazjenti kkurati b’ doża ta ’ 4 mg jew anqas ta ’ risperidone mill- ħalq għandhom jirċievu 25 mg RISPERDAL CONSTA, filwaqt li pazjenti kkurati b’ dożi ogħla mill- ħalq għandhom ikunu kkunsidrati għad- doża ogħla ta ’ 37. 5 mg ta ’ 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.
Fejn il- pazjenti m’ humiex qed jieħdu kura b’ risperidone mill- ħalq fl- istess ħin, id- dożaġġ ta ’ risperidone mill- ħalq li kien qed jittieħed qabel għandu jiġi kkunsidrat meta tingħażel id- doża tal- bidu għal ġol- muskolu.
The recommended starting dose is 25 mg RISPERDAL CONSTA every two weeks.
Id- doża tal- bidu rakkomandata hija ta ’ 25 mg RISPERDAL CONSTA kull
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.
22 ġimgħatejn.
The efficacy of the 12.5 mg dose has not been investigated in clinical trials.
Pazjenti fuq dożi ogħla ta ’ l- antipsikotiku użat mill- ħalq għandhom jiġu kkunsidrati għad - doża ogħla ta ’ 37. 5 mg ta ’ RISPERDAL CONSTA.
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).
Għandha tiġi żgurata protezzjoni antipsikotika suffiċjenti b’ risperidone mill- ħalq jew bil- mediċina antipsikotika ta ’ qabel wara li tingħata l- ewwel injezzjoni ta ’ RISPERDAL CONSTA waqt it- tliet ġimgħat ta ’ dewmien biex din tibda taħdem (ara sezzjoni 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.
RISPERDAL CONSTA m’ għandux jintuża f’ taħrix ta ’ skizofrenja akuta mingħajr ma tiġi żgurata protezzjoni antipsikotika suffiċjenti b’ risperidone mill- ħalq, jew bil- mediċina antipsikotika ta ’ qabel waqt it- tliet ġimgħat ta ’ dewmien wara li tingħata l- ewwel injezzjoni ta ’ RISPERDAL CONSTA sakemm din tibda taħdem.
Maintenance dose:
Doża ta ’ manteniment:
For most patients the recommended dose is 25 mg intramuscular every two weeks.
Għall- biċċa l- kbira tal- pazjenti d- doża rakkomandata hija ta ’ 25 mg kull ġimgħatejn.
Some patients may benefit from the higher doses of 37.5 mg or 50 mg.
Xi pazjenti jistgħu jkunu ta ’ ġid għalihom id- dożi ogħla ta ’ 37. 5 mg u 50 mg.
Upward dosage adjustment should not be made more frequently than every 4 weeks.
Aġġustament ta ’ żieda fid- doża m’ għandux isir aktar frekwenti minn kull 4 ġimgħat.
The effect of this dose adjustment should not be anticipated earlier than 3 weeks after the first injection with the higher dose.
L- effett ta ’ dan l- aġġustament tad- doża m’ għandux jiġi mistenni qabel 3 ġimgħat minn meta tingħata l- ewwel injezzjoni tad- doża ogħla.
No additional benefit was observed with 75 mg in clinical trials.
L - ebda ġid addizzjonali ma kien osservat b’ 75 mg fil- provi kliniċi.
Doses higher than 50 mg every 2 weeks are not recommended.
Dożi ogħla minn 50 mg kull ġimgħatejn m’ humiex rakkomandati.
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.
F’ pazjenti b’ fatturi kliniċi bħal indeboliment epatiku jew renali jew ma ’ ċerti mediċini li ma jaqblux ma ’ risperidone u jżidu l- konċentrazzjonijiet tiegħu fil- plażma (ara sezzjoni 4. 5), tnaqqis tad- doża li titbaxxa sa ’ 12. 5 mg jista ’ jkun xieraq.
The efficacy of the 12.5 mg dose has not been investigated in clinical trials.
L- effikaċja tad- doża ta ’ 12. 5 mg ma ġietx investigata fil- provi kliniċi.
Elderly No dose adjustment is required.
Anzjani L- ebda aġġustament tad- doża ma huwa meħtieġ.
The recommended dose is 25 mg intramuscularly every two weeks.
Id- doża rrakkomandata hija ta ’ 25 mg ġol- muskolu kull ġimgħatejn.
Where patients are not currently taking oral risperidone, the recommended dose is 25 mg RISPERDAL CONSTA every two weeks.
Fejn il- pazjenti m’ humiex qed jieħdu risperidone mill- ħalq fl- istess ħin, id- doża rakkommandata hija ta ’ 25 mg RISPERDAL CONSTA kull ġimgħatejn.
For those patients on a fixed dose of oral risperidone for two weeks or more, the following conversion scheme should be considered.
Għal dawk il- pazjenti fuq doża fissa ta ’ risperidone mill- ħalq għal perjodu ta ’ ġimgħatejn jew aktar, l- iskema ta ’ konverżjoni li ġejja għandha tiġi kkunsidrata.
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.
Pazjenti kkurati b’ doża ta ’ 4 mg jew anqas ta ’ risperidone mill- ħalq għandhom jirċievu 25mg ta ’ RISPERDAL CONSTA, filwaqt li pazjenti kkurati b’ dożi ogħla mill- ħalq għandhom ikunu kkunsidati għad- doża ogħla ta ’ 37. 5 mg ta ’ RISPERDAL CONSTA.
Sufficient antipsychotic coverage should be ensured during the three-week lag period following the first RISPERDAL CONSTA injection (see section 5.2).
Għandha tiġi żgurata protezzjoni antipsikotika suffiċjenti wara li tingħata l- ewwel injezzjoni ta ’ RISPERDAL CONSTA waqt it- tliet ġimgħat ta ’ dewmien biex din tibda taħdem (ara sezzjoni 5. 2).
RISPERDAL CONSTA clinical data in elderly are limited.
Tagħrif kliniku dwar RISPERDAL CONSTA fl- anzjani huwa limitat.
RISPERDAL CONSTA should be used with caution in elderly.
RISPERDAL CONSTA għandu jintuża b’ attenzjoni fl- anzjani.
Hepatic and renal impairment RISPERDAL CONSTA has not been studied in hepatically and renally impaired patients.
Indeboliment epatiku u renali RISPERDAL CONSTA ma ġiex studjat f’ pazjenti b’ indebolimet epatiku jew renali.
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.
Jekk pazjenti b’ indeboliment epatiku jew renali jinħtieġu kura b’ RISPERDAL CONSTA, doża tal - bidu ta ’ 0. 5 mg risperidone mill- ħalq darbtejn kuljum hija rrakkomandata waqt l- ewwel ġimgħa.
The second week 1 mg twice daily or 2 mg once daily can be given.
Fit - tieni ġimgħa jistgħu jingħataw 1 mg darbtejn kuljum jew 2mg darba kuljum.
If an oral total daily dose of at least 2 mg is well tolerated, an injection of 25 mg RISPERDAL CONSTA can be administered every 2 weeks.
Jekk doża totali ta ’ mill - anqas 2 mg kuljum tkun ittolerata tajjeb, injezzjoni ta ’ 25 mg RISPERDAL CONSTA tista ’ tingħata kull ġimgħatejn.
Alternatively, a starting dose of RISPERDAL CONSTA of 12.5 mg may be appropriate.
B’ mod alternattiv, doża tal- bidu ta’ 12. 5mg RISPERDAL CONSTA tista ’ tkun xierqa.
The efficacy of the 12.5 mg dose has not been investigated in clinical trials.
L- effikaċja tad - doża ta ’ 12. 5mg ma ġietx investigata fi provi kliniċi.
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.
23 RISPERDAL CONSTA mhux irrakkomandat għall- użu fit- tfal ta ’ taħt il- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
RISPERDAL CONSTA should be administered every two weeks by deep intramuscular gluteal injection using the enclosed safety needle.
RISPERDAL CONSTA għandu jingħata kull ġimgħatejn b’ injezzjoni fil- fond ġol- muskolu gluteali permezz tal- labra ta ’ sigurtà li ssib miegħu.
Injections should alternate between the buttocks.
L- injezzjonijiet għandhom jalternaw bejn naħa u oħra tal - warrani.
Do not administer intravenously (see section 4.4 and section 6.6).
Tagħtihx ġol- vina (ara sezzjoni 4. 4 u sezzjoni 6. 6).
22 For instructions on preparation and handling RISPERDAL CONSTA, see section 6.6.
Għal struzzjonijiet dwar il- preparazzjoni u l- immaniġġar ta ’ RISPERDAL CONSTA, ara sezzjoni 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).
F’ pazjenti inġenwi għal risperidone, huwa rakkomandat li tiġi stabbilita tolleranza b’ risperidone mill - ħalq qabel ma ’ tinbeda kura b’ RISPERDAL CONSTA (ara sezzjoni 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.
RISPERDAL CONSTA ma kienx studjat f’ pazjenti anzjani bid- dimenzja, għalhekk m’ huwiex indikat għall- użu f’ dan il- grupp ta ’ pazjenti.
Overall mortality
Mortalità Totali
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.
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 mill- ħalq.
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.
Fi provi kliniċi kkontrollati bi plaċebo b’ RISPERDAL mill- ħalq 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.
The odds ratio (95% exact confidence interval) was 1.21 (0.7, 2.1).
Il- porzjon ta ’ probabbiltà (95% intervall ta ’ kunfidenza eżatta) kien 1. 21 (0. 7, 2. 1).
The mean age (range) of patients who died was 86 years (range 67-100).
L- età medja (medda) tal- pazjenti li mietu kienet ta ’ 86 sena (medda bejn 67- 100).
Concomitant use with furosemide
Użu Flimkien ma ’ Furosemide
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).
Fil- provi kkontrollati bi plaċebo għall- RISPERDAL mill- ħalq 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 sena, medda 70- 96) jew furosemide waħdu (4. 1%; età medja 80 sena, limiti 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.
Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings.
L- użu ta ’ risperidone flimkien ma ’ dijuretiċi oħra (l- aktar diuretiċi thiazide użati f’ doża baxxa) ma kienx assoċjat ma ’ sejbiet bħal dawn.
No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed.
L- ebda mekkaniżmu patofiżjoloġiku ma ġie identifikat biex jispjega dawn is- sejbiet, u l- ebda mudell konsistenti għall- kawża tal- mewt ma ġie osservat.
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 ikkunsidrati 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.
Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be carefully avoided in elderly patients with dementia.
Irrispettivament mill- kura, id- deidratazzjoni kienet fattur ta ’ riskju totali għall- mortalità u għalhekk għandha tingħata attenzjoni biex tiġi evitata f’ pazjenti bid- dimenzja.
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).
24 Fi provi kkontrollati bi plaċebo f’ pazjenti anzjani bid- dimenzja kien hemm inċidenza sinifikament ogħla (bejn wieħed u ieħor 3- darbiet aktar) ta ’ CVAEs, bħal puplesija (inkluż imwiet) u attakk iskemiku għaddieni f’ pazjenti kkurati b’ RISPERDAL meta mqabbla ma ’ pazjenti kkurati bi plaċebo (età medja 85 sena; medda 73 sa 97).
An increased risk cannot be excluded for other antipsychotics or other patient populations.
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.
RISPERDAL CONSTA should be used with caution in patients with risk factors for stroke.
Il- porzjon ta ’ probabbilità (95% intervall ta ’ kunfidenza eżatta) kien 2. 96 (1. 34, 7. 50).
23 Orthostatic hypotension
Pressjoni Baxxa Ortostatika
Due to the alpha-blocking activity of risperidone, (orthostatic) hypotension can occur, especially during initiation of treatment.
Minħabba l- attività ta ’ risperidone li jimblokka r- riċetturi alfa, pressjoni baxxa (ortostatika) tista ’ sseħħ, speċjalment waqt il- bidu tal- kura.
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.
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).
Risperidone 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).
The risk/ benefit of further treatment with RISPERDAL CONSTA should be assessed if clinically relevant orthostatic hypotension persists.
Ir- riskju/ benefiċċjuli titkompla kura b ’ RISPERDAL CONSTA għandu jiġi vvalutat jekk pressjoni baxxa mal- waqfien li tkun klinikament sinifikanti tippersisti.
Tardive dyskinesia/ extrapyramidal symptoms (TD/ EPS)
Diskajniżja Tardiva/ Sintomi Ekstrapiramidali (TD/ EPS)
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.
The onset of extrapyramidal symptoms is a risk factor for tardive dyskinesia.
Il- bidu ta ’ sintomi ekstrapiramidali huwa fattur ta ’ riskju għal diskajniżja tardiva.
If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics should be considered.
Jekk jidhru sinjali jew sintomi ta ’ diskajniżja tardiva, għandu jiġi kkunsidrat it- twaqqif ta ’ l - antipsikotiċi kollha.
Neuroleptic malignant syndrome (NMS)
Sindrome Newrolettiku Malinn (NMS)
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 li jogħlew ġew irrappurtati li jseħħu b’ antipsikotiċi.
Additional signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Sinjali oħra jistgħu jinkludu mijoglobinurja (rabdomajoliżi) u indeboliment akut tal- kliewi.
In this event, all antipsychotics, including RISPERDAL CONSTA, should be discontinued.
F’ dan il- każ, l- antipsikotiċi kollha, inkluż RISPERDAL CONSTA, għandhom jitwaqqfu.
Parkinson’ s disease and dementia with Lewy bodies
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 CONSTA, 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.
Dawn 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 iż- żieda fis- sensittività tista ’ tinkludi konfużjoni, tmewwit, instabbilità li twassal għal waqgħat frekwenti, flimkien ma ’ sintomi ekstrapiramidali.
Hyperglycemia
Ipergliċemija
Hyperglycemia or exacerbation of pre-existing diabetes has been reported in very rare cases during treatment with RISPERDAL CONSTA.
Ipergliċemija jew taħrix ta ’ dijabete li diġa ’ teżisti kienet irrappurtata f’ każi rari ħafna waqt kura b’ RISPERDAL CONSTA.
Appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.
Monitoraġġ kliniku xieraq huwa rrakomandat f’ pazjenti dijabetiċi u f’ pazjenti b’ fatturi ta ’ riskju li jiżviluppaw dijabete mellitus.
Hyperprolactinaemia
Iperprolaktinimja
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
RISPERDAL CONSTA should be used with caution in patients with pre- existing hyperprolactinaemia and in patients with possible prolactin-dependent tumours.
RISPERDAL CONSTA 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 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 (ipokalimija, ipomagnesimja), minħabba li jista ’ jkabbar ir- riskju ta ’ effetti arritmoġeniċi, u meta jintuża flimkien ma ’ mediċini magħrufa li jtawwlu l- intervall QT
24 Seizures
Aċċessjonijiet
RISPERDAL CONSTA should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
RISPERDAL CONSTA għandu jintuża b’ attenzjoni f’ pazjenti b’ passat ta ’ aċċessjonijiet jew kundizzjonijiet oħra li għandhom il- potenzjal li jkabbru l- possibiltà ta ’ aċċessjoni.
Priapism Priapism may occur with RISPERDAL CONSTA treatment due to its alpha-adrenergic blocking effects.
Priapiżmu jista ’ jseħħ bil- kura ta ’ RISPERDAL CONSTA minħabba l- effetti tiegħu li jimblokka r - riċetturi adrenerġiċi alfa.
Body temperature regulation
Regulazzjoni tat- Temperatura tal- Ġisem
Disruption of the body’ s ability to reduce core body temperature has been attributed to antipsychotic medicines.
Disturbi fil- ħila tal- ġisem li jnaqqas it- temperatura tal- qalba tal- ġisem ġew attribwiti għall- mediċini antipsikotiċi.
Appropriate care is advised when prescribing RISPERDAL CONSTA 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 tingħata attenzjoni xierqa meta RISPERDAL CONSTA jinkiteb lil pazjenti li se 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.
Weight gain
Żieda fil- Piż
As with other antipsychotics, patients should be advised of the potential for weight gain.
Bħal b’ antipsikotiċi oħrajn, il- pazjenti għandhom jiġu mwissija li jista ’ jkollhom żieda fil- piż.
Weight should be measured regularly.
Il- piż għandu jitkejjel b’ mod regolari.
Renal or hepatic impairment
Indeboliment Renali u Epatiku
Although oral risperidone has been studied, RISPERDAL CONSTA has not been studied in patients with renal or liver insufficiency.
Għalkemm risperidone li jittieħed mill- ħalq ġie studjat, RISPERDAL CONSTA ma kienx studjat f’ pazjenti b’ insuffiċjenza renali jew epatika.
RISPERDAL CONSTA should be administered with caution in this group of patients (see section 4.2).
RISPERDAL CONSTA għandu jingħata b’ attenzjoni f’ dan il- grupp ta ’ pazjenti (ara sezzjoni 4. 2).
Care must be taken to avoid inadvertent injection of RISPERDAL CONSTA into a blood vessel.
Għandha tingħata attenzjoni biex RISPERDAL CONSTA ma jiġix injettat bi żball ġo arterja jew ġo vina.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e., essentially ‘ sodium- free’.
Dan il- prodott mediċinali fih anqas minn 1 mmol ta ’ sodium (23 mg) f’ kull doża, i. e. huwa essenzjalment ‘ mingħajr sodium ’.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l - effett farmaċewtiku tal- prodott
Interaction studies were performed with oral RISPERDAL.
Studji dwar mediċini li ma jaqblux miegħu saru b’ RISPERDAL mill- ħalq.
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 antidepressants (i. e., amitriptyline), tetracyclic antidepressant (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.
26 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), antidepressanti triċikliċi (i. e., amitriptylene), antidepressant tetraċikliku (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.
This list is indicative and not exhaustive.
Din il- lista hija indikattiva iżda mhux kompluta.
Potential for RISPERDAL CONSTA to affect other medicinal products
Il- potenzjal ta ’ RISPERDAL CONSTA 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 li l- aktar jinkludu l- alkoħol, opiates, anti- istaminiċi, u benzodiazepines minħabba żieda fir- riskju ta ’ sedazzjoni.
25 RISPERDAL CONSTA may antagonise the effect of levodopa and other dopamine agonists.
RISPERDAL CONSTA 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.
Pressjoni baxxa klinikament sinifikanti kienet osservata wara t- tqegħid fis- suq permezz ta ’ risperidone użat flimkien ma ’ kura kontra l- pressjoni għolja.