qanastek/EMEA-V3 huggingface dataset:
RISPERDAL does not show a clinically relevant effect on the pharmacokinetics of lithium, valproate, digoxin or topiramate.
RISPERDAL ma jurix effett klinikament sinifikanti fuq il- farmakokinetika ta ’ lithium, valproate, digoxin jew topiramate.
Potential for other medicinal products to affect RISPERDAL CONSTA
Il- potenzjal ta ’ prodotti mediċinali oħra li jaffettwaw RISPERDAL CONSTA
Carbamazepine has been shown to decrease the plasma concentrations of the active antipsychotic fraction of risperidone.
Carbamazepine intwera li jnaqqas il- konċentrazzjonijiet fil- plażma tal- porzjon antipsikotiku attiv ta ’ risperidone.
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 eż. b’ 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 CONSTA.
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 CONSTA.
Fluoxetine and paroxetine, CYP 2D6 inhibitors, increase the plasma concentration of risperidone, but less so of the active antipsychotic fraction.
Fluoxetine u paroxetine, impedituri ta ’ CYP 2D6, iżidu l- konċentrazzjoni ta ’ risperidone fil- plażma, iżda mhux daqstant il- porzjon antipsikotiku attiv.
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, jista ’ jaffettwa l- 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 CONSTA.
Meta fluoxetine jew paroxetine mogħtija flimkien ma ’ risperidone jinbdew jew jitwaqqfu, it- tabib għandu jevalwa mill- ġdid id- dożaġġ ta ’ RISPERDAL CONSTA.
Verapamil, an inhibitor of CYP 3A4 and P-gp, increases the plasma concentration of risperidone.
Verapamil, impeditur ta’ CYP 3A4 u ta ’ P- gp, iżid il- konċentrazzjoni ta ’ risperidone fil- plażma.
Galantamine and donepezil do not show a clinically relevant effect on the pharmacokinetics of risperidone and on the active antipsychotic fraction.
Galantamine u donepezil ma jurux effett kilinikament relevanti fuq il- farmakokinetika ta ’ risperidone u fuq il - porzjon antipsikotiku attiv.
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 blokkaturi tar- riċetturi beta jistgħu jżidu l - konċentrazzjonijiet ta ’ risperidone fil- plażma iżda mhux dawk tal- porzjoni 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 dik tal- porzjon antipsikotiku attiv.
Erythromycin, a CYP 3A4 inhibitor, does not change the pharmacokinetics of risperidone and the active antipsychotic fraction.
Erythromycin, impeditur ta ’ CYP 3A4 ma jibdilx il- farmakokinetika ta ’ risperidone u l- porzjon antipsikotiku attiv.
See section 4.4 regarding increased mortality in elderly patients with dementia concomitantly receiving furosemide.
Ara sezzjoni 4. 4 dwar mortalità ogħla f’ pazjenti anzjani bid- dimenzja li qed jirċievu wkoll furosemide.
4.6 Pregnancy and lactation
27 4. 6 Tqala u effetti fuq il- ħalib tas- sider
There are no adequate data from the use of risperidone in pregnant women.
Tqala M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ risperidone waqt it- tqala.
According to postmarketing data reversible extrapyramidal symptoms in the neonate were observed following the use of risperidone during the last trimester of pregnancy.
Skond tagħrif ta ’ wara t- tqegħid fis- suq sintomi ekstrapiramidali riversibbli fit- trabi tat- twelid kienu osservati wara l- użu ta ’ risperidone fl- aħħar trimestru tat- tqala.
Consequently, newborns should be monitored carefully.
Konsegwentement, trabi tat- twelid għandhom jiġu mmonitorjati b’ attenzjoni.
Risperidone was not teratogenic in animal studies but other types of reproductive toxicity were seen (see section 5.3).
Risperidone ma kienx teratoġeniku fi studji fuq l- annimali iżda ntwerew tipi oħra ta ’ ħsara fuq is- sistema riproduttiva (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Ir- riskju li jista ’ jkun hemm fuq in - nies m’ huwiex magħruf.
Therefore, RISPERDAL CONSTA should not be used during pregnancy unless clearly necessary.
Għalhekk, RISPERDAL CONSTA m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
In animal studies, risperidone and 9-hydroxy-risperidone are excreted in the milk.
Effetti fuq il- ħalib tas- sider Fi studji fuq l- annimali, risperidone u 9- hydroxy- risperidone joħorġu mal- ħalib tas- sider.
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 joħorġu wkoll mal- ħalib uman fi kwantitajiet żgħar.
There are no data available on adverse effects in breast-feeding infants.
M’ hemmx tagħrif disponibbli dwar l- effetti avversi jekk tredda ’ lit- trabi.
Therefore, the advantage of breast-feeding should be weighed against the potential risks for the child.
Għalhekk il- vantaġġ tat- treddigħ għandu jitqies skond ir- riskji li jista ’ jkun hemm għat- tarbija.
RISPERDAL CONSTA has minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects (see section 4.8).
RISPERDAL CONSTA għandu effett żgħir jew moderat fuq il- ħila li ssuq u tħaddem magni minħabba l- effetti li jista ’ jkollu fuq is- sistema nervuża u l- vista (ara sezzjoni 4. 8).
Therefore, patients should be advised not to drive or operate machinery until their individual susceptibility is known.
Għalhekk, il - pazjenti għandhom jingħataw il- parir li ma jsuqux u jħaddmu makkinarju sakemm ikun magħruf kemm huma suxxettibbli b’ mod individwali.
Insomnia, anxiety, headache, upper respiratory tract infection, parkinsonism, depression, and akathisia.
L- aktar effetti mhux mixtieqa (ADRs) irrappurtati b’ mod frekwenti (inċidenza ≥ 1/ 10) huma: insomnja, ansjetà, uġigħ ta ’ ras, infezzjoni fil- parti tan- naħa ta ’ fuq ta ’ l- apparat tan- nifs, Parkinsoniżmu, depressjoni, u akatisja.
The following are all the ADRs that were reported in clinical trials and postmarketing.
Dawn li ġejjin huma kollha ADRs li kienu rrappurtati fi provi kliniċi u wara t- tqegħid fis- suq.
The following terms and frequencies are applied: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000), very rare (< 1/ 10,000), and not known (cannot be estimated from the available clinical trial data).
Dawn it- termini u l- frekwenzi li ġejjin huma użati: komuni ħafna (≥ 1/ 10), komuni (≥ 1/ 100 sa < 1/ 10), mhux komuni (≥ 1/ 1000 sa < 1/ 100), rari (≥ 1/ 10, 000 sa < 1/ 1, 000), rari ħafna (< 1/ 10, 000), u mhux magħrufa (ma jistgħux jiġu stmati mid- dejta disponibbli mill- provi kliniċi).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ kull grupp ta ’ frekwenza, l- effetti mhux mixtieqa huma ppreżentati skond is- serjetà tagħhom li dejjem tonqos.
Electrocardiogram abnormal, Blood prolactin increaseda, Blood glucose increased, Hepatic enzyme increased, Transaminases increased, Gamma-glutamyltransferase increased, Weight increased, Weight decreased
Reazzjonijiet Avversi skond is- Sistema tal- Klassifikazzjoni ta ’ l- Organi u l- Frekwenza Investigazzjonijiet Elettrokardjogramm mhux normali, Żieda tal- prolactin fid- demma, Żieda taz - Komuni zokkor fid- demm, Żieda fl- enzimi tal- fwied, Żieda fit- transaminases, Żieda fil - gamma glutamyltransferase, Żieda fil- piż, Tnaqqis fil- piż
Electrocardiogram QT prolonged
QT ta ’ l- elettrokardjogramm imtawwal
Atrioventricular block, Tachycardia Bundle branch block, Atrial fibrillation, Bradycardia, Sinus bradycardia, Palpitations
Imblokk atrijoventikulari, Takikardija Imblokk tal- fergħa bundle, Fibrillazzjoni ta ’ l- atriju, Bradikardija, Bradikardija tas- sinus, Palpitazzjonijiet
Blood and lymphatic system disorders Common Uncommon Not known
Disturbi tad- demm u tas- sistema limfatika
Nervous system disorders Very common Common
Mhux komuni Rari Mhux magħrufa
Parkinsonismb, Akathisiab, Headache Dizziness, Sedation, Somnolence, Tremor, Dystoniab, Tardive dyskinesia, Dyskinesiab
Anemija, Troboċitpenija, Newtropenija Agranuloċitożi
Uncommon Eye disorders
Disturbi fis- sistema nervuża
Convulsion, Syncope, Dizziness postural, Hypoaesthesia, Paraesthesia, Lethargy, Hypersomnia
28 Parkinsoniżmub, Akatisjab, Uġigħ ta ’ ras Komuni ħafna Sturdament, Sedazzjoni, Ħedla tan- ngħas, Rogħda, Distonijab,, Diskajeżja Komuni tardiva, Diskajneżjab, Mhux komuni Disturbi fl- għajnejn
Vision blurred, Conjunctivitis Retinal artery occlusion
Aċċessjonijiet, Sinkope, Sturdament mal- waqfien, Ipoesteżija, Parestesija, Letarġija, Ipersomnja
Respiratory, thoracic and mediastinal disorders Common Rare
Komuni Mhux magħrufa Disturbi fil- widnejn u Komuni Mhux komuni Disturbi respiratorji, Komuni Rari
Dyspnoea, Cough, Nasal congestion, Pharyngolaryngeal pain Sleep apnea syndrome
Vista mċajpra, Konġunktivite Sadda ta ’ l- arterja tar- retina fis- sistema labirintika Vertiġini Uġigħ fil- widnejn toraċiċi, u medjastinali Qtugħ ta ’ nifs, Sogħla, Konġestjoni nażali, Uġigħ faringolarinġali Sindrome ta ’ waqfien tan- nifs waqt l- irqad
Vomiting, Diarrhoea, Constipation, Nausea, Abdominal pain, Dyspepsia, Toothache, Dry mouth, Stomach discomfort, Gastritis
Rimettar, Dijarea, Stitikezza, Dardir, Uġigħ fl- addome, Dispepsja, Uġigħ fis - snien, Ħalq xott, Skomfort fl- istonku, Gastrite
Intestinal obstruction, Pancreatitis
Sadd fl- imsaren, Pankrejatite
Skin and subcutaneous tissue disorders Common Uncommon
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Komuni Mhux komuni
Rash, Eczema Angioedema, Pruritus, Acne, Alopecia, Dry skin
Raxx, Ekżema Anġjoedima, Ħakk, Akne, Alopeċja, Ġilda xotta
Musculoskeletal and connective tissue disorders Common Uncommon Endocrine disorders
Disturbi muskolu- skelettrali u tal- connective tissue Komuni Mhux komuni
Arthralgia, Back pain, Pain in extremity, Myalgia Muscular weakness, Neck pain, Buttock pain, Musculoskeletal chest pain
Artralġja, Uġigħ fid- dahar, Uġigħ fl- idejn u fis- saqajn, Majalġja Dgħjufija tal- muskoli, Uġigħ fl- għonq, Uġigħ fil- warrani, Uġigħ muskoluskelettrali fis- sider
Metabolism and nutrition disorders Uncommon Very rare Not known
Disturbi fis- sistema endokrinarja Rari Tnixxija mhux adattata ta ’ ormon antidijuretiku Disturbi fil- metaboliżmu u n- nutrizzjoni Mhux Komuni Rari ħafna Mhux magħrufa
Increased appetite, Decreased appetite Diabetic ketoacidosis Water intoxication
Żieda fl- aptit, Tnaqqis fl- aptit Ketoaċidożi dijabetika Intossikazzjoni ta ’ ilma
Infections and infestations Very common Common
Infezzjonijiet u infestazzjonijiet Komuni ħafna Komuni
Upper respiratory tract infection Pneumonia, Influenza, Lower respiratory tract infection, Bronchitis, Urinary tract infection, Ear infection, Sinusitis, Viral infection
Infezzjoni tal- parti tan- naħa ta ’ fuq ta ’ l- apparat tan- nifs Pulmonite, Influwenza, Infezzjoni tal- parti tan- naħa t’ isfel ta ’ l- apparat tan - nifs, Bronkite, Infezzjoni fl- apparat ta ’ l- awrina, Infezzjoni fil- widnejn, Sinożite, Infezzjoni virali
Cystitis, Gastroenteritis, Infection, Localised infection, Subcutaneous abscess
Ċistite, Gastroenterite, Infezzjoni, Infezzjoni lokalizzata, Axxess taħt il- ġilda
Common Uncommon
Korriment u avvalenament Komuni Mhux komuni Disturbi vaskulari
Fall Procedural pain
Waqa ’ Uġigħ waqt proċedura
Vascular disorders
Komuni Mhux komuni
Hypertension, Hypotension Orthostatic hypotension
Pressjoni għolja, Pressjoni baxxa Pressjoni baxxa mal- waqfien
General disorders and administration site conditions
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata Komuni
Pyrexia, Peripheral oedema, Chest pain, Fatigue, Pain, Injection site pain, Asthenia, Influenza like illness
Deni, Edima ta ’ l- idejn u tas- saqajn, Uġigħ fis- sider, Għejja, Uġigħ, Uġigħ fis - sit ta ’ l- injezzjoni, Astenja, Mard bħla ta ’ l- influwenza
Feeling abnormal, Chest discomfort, Induration, Injection site induration, Sluggishness, Injection site reaction
Ma tħossokx normali, Skomfort fis- sider, Ħmura, Ħmura fis- sit ta ’ l- injezzjoni Indolenza, Reazzjoni fis- sit ta ’ l- injezzjoni
Immune system disorders
Disturbi fis- sistema immuni Mhux komuni Mhux magħrufa
Hypersensitivity Anaphylactic reaction
Sensittività eċċessiva Reazzjoni anafilattika
Hepatobiliary disorders
Disturbi fil- fwied u fil- marrara Rari Suffejra
Reproductive system and breast disorders
29 Disturbi fis- sistema riproduttiva u fis- sider
Common Uncommon Not known
Mhux komuni Rari Mhux magħrufa Disturbi psikjatriċi
Amenorrhoea, Erectile dysfunction, Galactorrhoea Sexual dysfunction, Gynaecomastia Priapism
Amenorreja, Disfunzjoni erettili, Galaktorreja Disfunzjoni sesswali, Ġinekomastja Priapiżmu
Very common Common Uncommon
Komuni ħafna Komuni Mhux komuni a
Depression, Insomnia, Anxiety Agitation, Sleep disorder Mania, Libido decreased, Nervousness
Depressjoni, Insomnja, Ansjetà Aġitazzjoni, Disturb fl- irqad Manija, Tnaqqis fil- libido, Nervożiżmu
Hyperprolactinemia can in some cases lead to gynaecomastia, menstrual disturbances, amenorrhoea, galactorrhea. b Extrapyramidal disorder may occur:
Iperprolaktinimja tista ’ f’ xi każijiet twassal għal ġinekomastja, disturbi menstruwali, amenorreja, galaktorreja. b Jista ’ jseħħ disturb ekstrapiramidali:
Parkinsonism (salivary hypersecretion, musculoskeletal stiffness, parkinsonism, drooling, cogwheel rigidity, bradykinesia, hypokinesia, masked facies, muscle tightness, akinesia, nuchal rigidity, muscle rigidity, parkinsonian gait, and glabellar reflex abnormal), akathisia (akathisia, restlessness, hyperkinesia, and restless leg syndrome), tremor, dyskinesia (dyskinesia, muscle twitching, choreoathetosis, athetosis, and myoclonus), dystonia.
Parkinsoniżmu (ipersekrezzjoni ta ’ bżiq, ebusija muskolu - skeletrali, parkinsoniżmu, tlegħib, riġidità bħal tar- roti f’ magna, bradikajniżja, ipokajniżja, espressjoni tal- wiċċ bħal maskra, tagħfis fil- muskoli, akineżja, riġidità ta ’ raqbet l- għonq, riġidità fil - muskoli, mixi parkinsonjan, u rifless glabellari mhux normali), Akatiżja (akatiżja, nuqqas ta ’ kwiet, iperkajneżja u sindrome ta ’ saqajn bla kwiet), rogħda, diskajneżja (diskajneżja, kontrazzjoni tal - muskoli għall- għarrieda, koreoatetożi, atetożi, u mijoklonus), distonija.
Dystonia includes dystonia, muscle spasms, hypertonia, torticollis, muscle contractions involuntary, muscle contracture, blepharospasm, oculogyration, tongue paralysis, facial spasm, laryngospasm, myotonia, opisthotonus, oropharyngeal spasm, pleurothotonus, tongue spasm, and trismus.
Distonja tinkludi distonja, spażmi fil- muskoli, ipertonija, tortikollis, kontrazzjonijiet involuntarji tal- muskoli, kontrazzjoni tal- muskoli, blefarospażmu, għajnejn iduru, paraliżi fl- ilsien, spażmu fil- wiċċ, spażmu fil- larinġi, mijotonija, opistotonus, spażmu orofarinġali, plewrototonus, spażmu fl- ilsien, u trismu.
Tremor includes tremor and parkinsonian rest tremor.
Rogħda jinkludi rogħda u rogħda parkinsonjan waqt il- mistrieħ.
It should be noted that a broader spectrum of symptoms are included, that do not necessarily have an extrapyramidal origin.
Għandu jkun innutat li qed jiġu inklużi firxa wiesa ta ’ sintomi li mhux neċessarjament għandhom oriġini ekstrapiramidali.
The following is a list of additional ADRs associated with risperidone that have been identified as ADRs during clinical trials investigating the oral risperidone formulation (RISPERDAL) but were not determined to be ADRs in the clinical trials investigating RISPERDAL CONSTA.
Din li ġejja hija lista addizzjonali ta ’ ADRs assoċjati ma ’ risperidone li kienu identifikati bħala ADRs waqt provi kliniċi li kienu qed jinvestigaw il- formulazzjoni ta ’ risperidone li tittieħed mill- ħalq (RISPERDAL) iżda ma kinux determinati li huma ADRs fil- provi kliniċi li kienu qed jinvestigaw RISPERDAL CONSTA.
Class effects
Effetti tal- klassi
As with other antipsychotics, very rare cases of QT prolongation have been reported postmarketing with risperidone.
Bħal antipsikotiċi oħrajn, każi rari ħafna ta ’ titwil tal- QT kienu rrrappurtati b’ risperidone wara t - tqegħid fis- suq.
Other class-related cardiac effects reported with antipsychotics which prolong QT interval include ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest and Torsades de Pointes.
Effetti oħra tal- qalb li huma relatati mal- klassi rrappurtati b’ antipsikotiċi li jtawwlu l - intervall QT jinkludu arritmija tal- ventrikulu, fibrillazzjoni tal- ventirikulu, takikardija tal- ventrikulu, mewt zoptu, waqfien tal- qalb u Torsades de Pointes.
Weight gain
31 Żieda fil- piż
In the 12-week double-blind, placebo-controlled trial, 9% of patients treated with RISPERDAL CONSTA, compared with 6% of patients treated with placebo, experienced a weight gain of ≥ 7% of body weight at endpoint.
Fi prova double- blind ta ’ 12- il ġimgħa kkontrollata bi plaċebo, 9% tal- pazjenti kkurati b’ RISPERDAL CONSTA mqabbla ma ’ 6% tal- pazjenti kkurati bi plaċebo esperjenzaw żieda fil- piż ta ’ ≥ 7% tal- piż ta ’ ġisimhom fl- aħħar stadju ta ’ l- istudju.
In the 1-year, open-label study of RISPERDAL CONSTA, changes in body weight in individual patients were generally within ±7% from baseline; 25% of patients had an increase in body weight of ≥ 7%.
Fl- istudju open- label ta ’ sena ta ’ RISPERDAL CONSTA, tibdil fil- piż tal- ġisem tal- pazjenti individwali kien ġeneralment fil- limiti ta’ ±7% mill- linja bażi; 25% tal- pazjenti kellhom żieda fil- piż ta ’ ≥ 7%.
While overdose is less likely to occur with parenteral than with oral medicinal products, information pertaining to oral is presented.
Filwaqt li doża eċċessiva hija anqas probabbli li sseħħ b’ mediċini parenterali milli b’ prodotti mediċinali li jittieħdu mill- ħalq, informazzjoni għal- doża eċċessiva mill- ħalq qed tiġi ppreżentata.
In general, reported signs and symptoms have been those resulting from an exaggeration of the known pharmacological effects of risperidone.
B’ mod ġenerali, is- sinjali u s- sintomi rrappurtati kienu dawk li jiġu minn esaġerazzjoni ta ’ l- effetti farmakoloġiċi magħrufa ta ’ risperidone.
These include drowsiness and sedation, tachycardia and hypotension, and extrapyramidal symptoms.
Dawn jinkludu ħedla u sedazzjoni, takikardja u pressjoni baxxa, u sintomi ekstrapiramidali.
In overdose, QT-prolongation and convulsions have been reported.
F’ każ ta ’ doża eċċessiva, QT li jitwal u aċċessjonijiet kienu rrappurtati.
Torsade de Pointes has been reported in association with combined overdose of oral RISPERDAL and paroxetine.
Torsade de Pointes kien irrappurtat b’ doża eċċessiva ta ’ RISPERDAL mill- ħalq flimkien ma ’ paroxetine.
In case of acute overdose, the possibility of multiple drug involvement should be considered.
Fil- każ ta ’ doża eċċessiva akuta għandha tiġi kkunsidrata l- possibiltà li ntużat aktar minn mediċina waħda.
Establish and maintain a clear airway and ensure adequate oxygenation and ventilation.
Stabilixxi u żomm il- passaġġ tan- nifs miftuħ u żgura ossiġnu u ventilazzjoni xierqa.
Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
Il- monitoraġġ kardjovaskulari għandu jibda mill- ewwel u għandu jinkludi monitoraġġ kontinwu elettrokardjografiku għal osservazzjoni tal- possibilità ta ’ arritmiji.
There is no specific antidote to RISPERDAL.
M’ hemm l- ebda antidot speċifiku għal- RISPERDAL.
Therefore appropriate supportive measures should be instituted.
Għaldaqstant, għandhom jinbdew miżuri xierqa ta ’ sapport.
Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids and/ or sympathomimetic agents.
Il- pressjoni baxxa u l- kollass ċirkulatorju għandhom jiġu kkurati b’ miżuri xierqa bħal fluwidi fil- vina u/ jew aġenti simpatomimetiċi.
In case of severe extrapyramidal symptoms, anticholinergic medicinal product should be administered.
F’ każ ta ’ sintomi ekstrapiramidali qawwija, għanda tingħata prodott mediċinali antikolinerġika.
Close medical supervision and monitoring should continue until the patient recovers.
Superviżjoni medika mill- qrib u monitoraġġ għandu jitkompla sakemm il- pazjenti jirkupra.
Other antipsychotics, ATC code:
Antipsikotiċi oħra, Kodiċi ATC:
Mechanism of action
Kif jaħdem
Risperidone is a selective monoaminergic antagonist with unique properties.
Risperidone huwa antagonist monoaminerġiku selettiv bi kwalitajiet uniċi.
It has a high affinity for serotoninergic 5-HT2 and dopaminergic D2 receptors.
Għandu affinità kbira għar - riċetturi serotonerġiċi 5- HT2 u dopaminerġiċi D2.
Risperidone binds also to alpha1-adrenergic receptors, and, with lower affinity, to H1-histaminergic and alpha2-adrenergic receptors.
Risperidone jeħel ukoll mar- riċetturi alpha1 - adrenerġiċi u b’ anqas affinità ma ’ riċetturi H1- istaminerġiċi u alpha2- adrenerġiċi.
Risperidone has no affinity for cholinergic receptors.
Risperidone m’ għandu l- ebda affinità għar- riċetturi kolinerġiċi.
Although risperidone is a potent D2 antagonist, that is considered to improve the positive symptoms of schizophrenia, it causes less depression of motor activity and induction of catalepsy than classical antipsychotics.
Għalkemm risperidone huwa antagonist potenti ta ’ D2, li huwa kkunsidrat li jtejjeb sintomi pożittivi ta ’ skizofrenja, huwa jikkawża anqas depressjoni u induzzjoni ta ’ katalessi minn antipsikotiċi klassiċi.
Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.
Antagoniżmu ċentrali bbilanċjat ta ’ serotonin u dopamine jista ’ jnaqqas it- tendenza għal effetti sekondarji ekstrapiramidali u jkabbar l- attività terapewtika għas- sintomi negattivi u affettivi ta ’ l- iskizofrenja.
Clinical efficacy The effectiveness of RISPERDAL CONSTA (25 mg and 50 mg) in the management of the manifestations of psychotic disorders (schizophrenia/ schizoaffective disorder) was established in one 12-week, placebo-controlled trial in adult psychotic inpatients and outpatients who met the DSM-IV criteria for schizophrenia.
32 Effikaċja klinika L- effikaċja ta ’ RISPERDAL CONSTA (25 mg u 50 mg) fl- immaniġġar tal- manifestazzjonijiet ta ’ disturbi psikotiċi (skizofrenja/ disturbi skizoaffettivi) kienet stabbilita fi prova waħda ta ’ 12- il ġimgħa kkontrollata bi plaċebo f’ pazjenti adulti psikotiċi fl- isptar u barra li ssodisfaw il- kriterji DSM- IV għall- iskizofrenja.
In a 12-week comparative trial in stable patients with schizophrenia, RISPERDAL CONSTA was shown to be as effective as the oral tablet formulation.
Fi studju kumparattiv ta ’ 12- il ġimgħa f’ pazjenti stabbli bi skizofrenja, RISPERDAL CONSTA intwera li kien effettiv daqs il- formulazzjoni li tittiehed mill- ħalq.
The long-term (50 weeks) safety and efficacy of RISPERDAL CONSTA was also evaluated in an open-label trial of stable psychotic inpatients and outpatients who met the DSM-IV criteria for schizophrenia or schizoaffective disorder.
Is- sigurtà u l- effikaċja ta ’ RISPERDAL CONSTA fuq tul ta ’ żmien (50 ġimgħa) kien ukoll evalwat fi prova open- label ta ’ pazjenti psikotici stabbli ġewwa l- isptar u barra li ssodisfaw il- kriterji għall- iskizofrenja jew disturb skizoaffettiv.
Over time efficacy was maintained with RISPERDAL CONSTA (Figure 1).
Matul iż- żmien l- effikaċja b ’ RISPERDAL CONSTA inżammet (Figura 1).
31 Figure 1.
Figura 1. skizofrenja.
Mean in total PANSS score over time (LOCF) in patients with schizophrenia.
Medja totali tal- punteġġ PANSS immarkata skond iż- żmien (LOCF) f’ pazjenti bi 90
90 Placebo RIS 25 mg RIS 50 mg
Placebo RIS 25 mg RIS 50 mg 85 80
85 80 Mean
Medja Mean
Endpt
Endpt Tmiem
Week
Ġimgħa Week
Absorption The absorption of risperidone from RISPERDAL CONSTA is complete.
Assorbiment L- assorbiment ta ’ risperidone minn RISPERDAL CONSTA huwa komplut.
After a single intramuscular injection with RISPERDAL CONSTA, the release profile consists of a small initial release of risperidone (< 1% of the dose), followed by a lag time of 3 weeks.
Wara doża waħda fil- muskolu b ’ RISPERDAL CONSTA, il- profil li bih jintreħa jikkonsisti f’ doża żgħira ta ’ risperidone merħija fil- bidu (< 1% tad- doża), segwita minn tliet ġimgħat ta ’ waqfien.
The main release of risperidone starts from Week 3 onwards, is maintained from 4 to 6 weeks, and subsides by Week 7.
Il - maġġoranza ta ’ risperidone jibda jintreħa mill- Ġimgħa 3 ’ il quddiem, jibqa sejjer għal bejn 4 u 6 ġimgħat, u jonqos fil- Ġimgħa 7.
Oral antipsychotic supplementation should therefore be given during the first 3 weeks of RISPERDAL CONSTA treatment (see section 4.2).
Supplimentazzjoni antipsikotika mill- ħalq għandha għalhekk tingħata waqt l- ewwel 3 ġimgħat ta ’ kura b ’ RISPERDAL CONSTA (ara sezzjoni 4. 2).
The combination of the release profile and the dosage regimen (intramuscular injection every two weeks) results in sustained therapeutic plasma concentrations.
Il- profil ta ’ kif jintreħa flimkien ma ’ kif tingħata d- doża (injezzjoni fil- muskolu kull ġimgħatejn) iwassal għaż- żamma ta ’ konċentrazzjonjiet terapewtiċi fil- plażma.
Therapeutic plasma concentrations remain until 4 to 6 weeks after the last RISPERDAL CONSTA injection.
Konċentrazzjonijiet terapewtiċi fil - plażma jibqgħu bejn 4 u 6 ġimgħat wara li tingħata l- aħħar injezzjoni ta ’ RISPERDAL CONSTA.
After repeated intramuscular injections with 25 or 50 mg RISPERDAL CONSTA every two weeks, median trough and peak plasma concentrations of the active antipsychotic fraction fluctuated between 9.9-19.2 ng/ ml and 17.9-45.5 ng/ ml respectively.
Wara injezzjonijiet ripetuti fil- muskolu b ’ 25 mg jew 50 mg ta ’ RISPERDAL CONSTA kull ġimgħatejn, il- medjan ta ’ l- anqas u l- ogħla konċentrazzjonijiet fil- plażma varja bejn 9. 9- 19. 2 ng/ ml u 17. 9- 45. 5 ng/ ml rispettivament.
No accumulation of risperidone was observed during long term use (12 months) in patients who were injected with 25– 50 mg every two weeks.
L- ebda akkumulazzjoni ta ’ risperidone ma ġiet osservata waqt użu għal tul ta ’ żmien (12- il xahar) f’ pazjenti li kienu injettati b’ 25- 50 mg kull ġimgħatejn.
Distribution Risperidone is rapidly distributed.
33 Distribuzzjoni Risperidone jiġi distribwit malajr.
The volume of distribution is 1-2 l/ kg.
Il- volum ta ’ distribuzzjoni huwa ta ’ 1- 2 l/ kg.
In plasma, risperidone is bound to albumin and alpha-1-acid glycoprotein.
Fil- plażma, risperidone jeħel ma ’ l- albumina u ma ’ alpha1- acid glycoprotein.
The plasma protein binding of risperidone is 90%; that of the active metabolite 9-hydroxy-risperidone is 77%.
It- twaħħil ta ’ risperidone mal - proteini tal- plażma huwa ta ’ 90%; dak ta ’ 9- hydroxy- risperidone huwa 77%.
Biotransformation and elimination Risperidone is metabolised by CYP 2D6 to 9-hydroxy-risperidone, which has a similar pharmacological activity as risperidone.
Biotransformazzjoni u eliminazzjoni Risperidone huwa immetabolizzat minn CYP 2D6 f’ 9- hydroxy- risperidone, li għandu attività farmakoloġika tixbah dik ta ’ risperidone.
Risperidone plus 9-hydroxy-risperidone form the active antipsychotic fraction.
Risperidone flimkien ma ’ 9- hydroxy risperidone jiffurmaw il- porzjon antipsikotiku attiv.
CYP 2D6 is subject to genetic polymorphism.
CYP 2D6 huwa suġġett għall- polimorfiżmu ġenetiku.
Extensive CYP 2D6 metabolisers convert risperidone rapidly into 9-hydroxy-risperidone, whereas poor CYP 2D6 metabolisers convert it much more slowly.
Metabolizzaturi estensivi ta ’ CYP 2D6 jibdlu risperidone malajr f’ 9- hydroxy- risperidone, filwaqt li metabolizzaturi nieqsa jibdluh ħafna aktar bil- mod.
Although extensive metabolisers have lower risperidone and higher 9-hydroxy-risperidone concentrations than poor metabolisers, the pharmacokinetics of risperidone and 9-hydroxy-risperidone combined (i. e., the active antipsychotic fraction), after single and multiple doses, are similar in extensive and poor metabolisers of CYP 2D6.
Minkejja li metabolizzaturi estensivi jkollhom konċentrazzjonijiet ta ’ risperidone aktar baxxi u ta ’ 9- hydroxy- risperidone aktar għoljin minn metabolizzaturi nieqsa, il - farmakokinetika ta ’ risperidone u ta ’ 9- hydroxy- risperidone flimkien (i. e., il- porzjon antipsikotiku attiv), wara doża waħda u ħafna dożi, jixtiebhu f’ metabolizzatturi estensivi u nieqsa ta ’ CYP 2D6.
32 Another metabolic pathway of risperidone is N-dealkylation.
Mogħdija metabolika oħra ta ’ risperidone hija N- dealkylation.
In vitro studies in human liver microsomes showed that risperidone at clinically relevant concentration does not substantially inhibit the metabolism of medicines metabolised by cytochrome P450 isozymes, including CYP 1A2, CYP 2A6, CYP 2C8/ 9/ 10, CYP 2D6, CYP 2E1, CYP 3A4, and CYP 3A5.
Studji in vitro fil- mikrosomi tal- fwied uman urew li risperidone f’ konċentrazzjoni klinikament rilevanti ma jimpedixxix b’ mod sostanzjali l - metaboliżmu tal- mediċini mmetabolizzati bl- isozimi taċ- ċitokroma P450, inkluż CYP 1A2, CYP 2A6, CYP 2C8/ 9/ 10, CYP 2D6, CYP 2E1, CYP 3A4, u CYP 3A5.
One week after oral risperidone administration, 70% of the dose is excreted in the urine and 14% in the faeces.
Ġimgħa wara l- għoti ta ’ rispridone mill - ħalq 70% tad- doża titneħħa fl- awrina u 14% ma ’ l- ippurgar.
In urine, risperidone plus 9-hydroxy-risperidone represent 35-45% of the orally administered dose.
Fl- awrina, risperidone flimkien ma ’ 9 - hydroxy- risperidone jirrapreżentaw 35- 45% tad- doża mogħtija mill- ħalq.
The remainder is inactive metabolites.
Il- kumplament huwa metaboliti inattivi.
The elimination phase is complete approximately 7 to 8 weeks after the last RISPERDAL CONSTA injection.
Il- fażi ta ’ eliminazzjoni tkun kompluta bejn wieħed u ieħor minn 7 sa 8 ġimgħat wara l- aħħar injezzjoni ta ’ RISPERDAL CONSTA.
Linearity The pharmacokinetics of risperidone following single doses of RISPERDAL CONSTA are linear in the dose range of 12.5-75 mg.
Linearità Il- farmakokinetika ta ’ risperidone wara dożi waħdiet ta ’ RISPERDAL CONSTA hija lineari fil- medda tad- doża bejn 12. 5- 75 mg.
The pharmacokinetics of risperidone are also linear in the dose range of 25-50 mg injected every 2 weeks.
Il- farmakokinetika ta ’ risperidone hija lineari wkoll fil- medda tad- doża ta ’ 25- 50 mg injettat kull ġimgħatejn.
Elderly, hepatic and renal impairment A single-dose pharmacokinetic study with oral risperidone showed on average a 43% higher active antipsychotic fraction plasma concentrations, a 38% longer half-life and a reduced clearance of the active antipsychotic fraction by 30% in the elderly.
Anzjani, indeboliment epatiku u renali Studju farmakokinetiku ta ’ doża waħda b’ risperidone mogħti mill- ħalq wera konċentrazzjonijiet li bħala medja kellhom porzjon antipsikotiku attiv 43% ogħla fil- plażma, half- life itwal b’ 38% u tnaqqis bi 30% fit- tneħħija tal- porzjon antipsiotiku attiv fl- anzjani.
Higher active antipsychotic fraction plasma concentrations and a reduced clearance of the active antipsychotic fraction by on average 60% were observed in patients with renal insufficiency.
Konċentrazzjonijiet ogħla tal- porzjon antipsikotiku attiv fil- plażma u tnaqqis fit- tneħħija tal- porzjon antipsikotiku attiv b’ medja ta ’ 60% kienu osservati f’ pazjenti b’ insuffiċjenza renali.
Risperidone plasma concentrations were normal in patients with liver insufficiency, but the mean free fraction of risperidone in plasma was increased by about 35%.
Konċentrazzjonijiet ta ’ risperidone fil- plażma kienu normali f’ pazjenti b’ insuffiċjenza epatika, iżda l- medja tal- porzjon liberu ta ’ risperidone fil- plażma żdiedet b’ madwar 35%.
Pharmacokinetic/ pharmacodynamic relationship There was no relationship between the plasma concentrations of the active antipsychotic fraction and the change in total PANSS (Positive And Negative Syndrome Scale) and total ESRS (Extrapyramidal Symptom Rating Scale) scores across the assessment visits in any of the phase-III trials where efficacy and safety was examined.
Relazzjoni farmakokinetika/ farmakodinamika Ma kien hemm l- ebda relazzjoni bejn il- konċentrazzjonijiet fil- plażma tal- porzjon antipsikotiku attiv u l- bidla fil- punteġġ totali PANSS (Skala tas- Sindrome Pożittiv u Negattiv) u fil- punteġġ totali ESRS (Skala ta ’ Klassifika tas- Sintomi Ekstrapiramidali) għall- visti ta ’ valutazzjoni kollha fi kwalunkwe mill- provi tal- fażi III fejn kienet eżaminata l- effikaċja u s- sigurtà.
Gender, race and smoking habits A population pharmacokinetic analysis revealed no apparent effect of gender, race or smoking habits on the pharmacokinetics of risperidone or the active antipsychotic fraction.
Sess, razza u tipjip Analiżi farmakokinetika ta ’ popolazzjojni ma wriet l- ebda effett evidenti ta ’ sess, razza jew tipjip fuq il- farmakokinetika ta ’ risperidone jew il- porzjon antipsikotiku attiv.
Similar to the (sub)chronic toxicity studies with oral risperidone in rats and dogs, the major effects of treatment with RISPERDAL CONSTA (up to 12 months of intramuscular administration) were prolactin-mediated mammary gland stimulation, male and female genital tract changes, and central nervous system (CNS) effects, related to the pharmacodynamic activity of risperidone.
Fi studji jixbhu lill dawk tossikoloġiċi (sotto) kroniċi li saru b’ risperidone mogħti mill- ħalq, fil- firien u l- klieb, l- aktar effetti importanti mill- kura b ’ RISPERDAL CONSTA (sa 12- il xahar ta ’ injezzjonijiet mogħtija fil- muskolu) kienu stimulazzjoni meditata mill- prolactin tal- glandoli mammarji, tibdiliet fil- passaġġ ġenitali fl- irġiel u fin- nisa, u effetti fuq is- sistema nervuża ċentrali (CNS), li għandhom x’ jaqsmu ma ’ l- attività farmakodinamika ta ’ risperidone.
Risperidone was not teratogenic in rat and rabbit.
34 Risperidone ma kienx teratoġeniku fil- far u fil- fenek.
In rats, intrauterine exposure to risperidone was associated with cognitive deficits in adulthood.
Fi studji ta ’ riproduzzjoni fil- firien b’ risperidone, ġew osservati effetti avversi fuq l- imġiba ta ’ tgħammir tal- ġenituri, u fuq il- piż tat - twelid u s- sopravivenza tal- frieħ. Fil- firien, esponiment fl- utru għal risperidone kien assoċjat ma ’ defiċjenzi konoxxittivi meta dawn saru adulti.
Other dopamine antagonists, when administered to pregnant animals, have caused negative effects on learning and motor development in the offspring.
Meta antagonisti oħrajn tad- dopamine ingħataw lil annimali tqal, dawn kellhom effetti negattivi fuq it- tagħlim u l- iżvilupp taċ- ċaqlieq fil- frieħ.
RISPERDAL CONSTA administration to male and female rats for 12 and 24 months produced osteodystrophy at a dose of 40 mg/ kg/ 2 weeks.
RISPERDAL CONSTA mogħti lill- firien irġiel u nisa għal 12 u 24 xahar ipproduċa osteodistrofija f’ doża ta ’ 40 mg/ kg/ ġimgħatejn.
The effect dose for osteodystrophy in rats was on a mg/ m2 basis 8 times the maximum recommended human dose and is associated with a plasma exposure 2 times the maximum anticipated exposure in humans at the maximum recommended dose.
Id- doża ta ’ effett għal osteodistrofija fil- firien kienet, fuq bażi ta ’ mg/ m2, 8 darbiet aktar mill- massimu tad- doża rakkomandata fil- bnedmin u hija assoċjata ma ’ esponiment fil- plażma d- doppju ta ’ l- esponiment massimu antiċipat fil- bnedmin għad- doża massima rakkomandata.
No osteodystrophy was observed in dogs treated for 12 months with RISPERDAL CONSTA up to 20 mg/ kg/ 2 weeks.
L- ebda osteodistrofija ma kienet osservata fil- klieb kkurati għal 12- il xahar b ’ RISPERDAL CONSTA f’ doża sa 20mg/ kg/ ġimgħatejn.
This dose yielded plasma exposures up to 14 times the maximum recommended human dose.
Din id- doża wasslet għal esponimenti fil - plażma sa 14- il darba d- doża massima rakkomandata fil- bnedmin.
There was no evidence of genotoxic potential.
Ma kienx hemm evidenza ta ’ potenzjal ġenotossiku.
33 As expected for a potent dopamine D2-antagonist, in oral carcinogenicity studies of risperidone in rats and mice, increases in pituitary gland adenomas (mouse), endocrine pancreas adenomas (rat), and mammary gland adenomas (both species) were seen.
Kif mistenni minn antagonist potenti tad- dopamine D2, fi studji ta ’ kanċeroġeniċità ta ’ risperidone orali fil- firien u l- ġrieden, intewerew żidiet fl- adenomi tal- glandola pitwitarja (ġurdien), adenomi endokrinali fil- frixa (far), u adenomi tal- glandoli mammarji (fiż- żewġ speċi).
In an intramuscular carcinogenicity study with RISPERDAL CONSTA in Wistar (Hannover) rats (doses of 5 and 40 mg/ kg/ 2 weeks), increased incidences of endocrine pancreas, pituitary gland, and adrenal medullary tumours were observed at 40 mg/ kg, while mammary gland tumours were present at 5 and 40 mg/ kg.
Fi studju ta ’ karċinoġenità ġol- muskolu b’ RISPERDAL CONSTA f’ firien Wistar (Hannover) (dożi ta ’ 5 u 40 mg/ kg/ ġimgħatejn), inċidenzi ogħla ta ’ tumuri endokrinali tal- frixa, tal- glandola pitwitarja u tal- medulla adrenali kienu osservati f’ doża ta ’ 40 mg/ kg, filwaqt li tumuri tal- glandola mammarja kienu preżenti f’ doża ta ’ 5 u 40 mg/ kg.
These tumours observed upon oral and intramuscular dosing can be related to prolonged dopamine D2 antagonism and hyperprolactinaemia.
Dawn it- tumuri osservati wara ddożar orali u ġol- muskolu jistgħu jkunu relatati ma ’ antagoniżmu fit- tul tad- dopamine D2 u iperprolaktinimja.
Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Kolturi ta ’ tessuti jissuġġerixxu li t- tkabbir taċ- ċelluli fit- tumuri tas- sider uman jistgħu jkunu stimulati minn prolactin.
Hypercalcemia, postulated to contribute to an increased incidence of adrenal medullary tumours in RISPERDAL CONSTA-treated rats, was observed in both dose groups.
Iperkalċimja, li wieħed jassumi li tikkontribwixxi għal inċidenza ogħla ta ’ tumuri tal- medulla adrenali f’ firien ikkurati b’ RISPERDAL CONSTA, kienet osservata fiż- żewġ gruppi ta ’ doża.
There is no evidence to suggest that hypercalcemia might cause phaeochromocytomas in humans.
M’ hemmx evidenza li tissuġġerixxi li l- iperkalċimja tista ’ tikkawża faokromoċitomi fil- bnedmin.
Renal tubular adenomas occurred in male rats treated with RISPERDAL CONSTA at 40 mg/ kg/ 2 weeks.
Adenomi renali tubulari seħħew f’ firien irġiel ikkurati b’ RISPERDAL CONSTA f’ doża ta ’ 40 mg/ kg/ ġimgħatejn.
No renal tumours occurred in the low dose, the NaCl 0.9%, or the microspheres vehicle control group.
L- ebda tumur renali ma seħħ fil- grupp tad- doża l- baxxa, ta ’ NaCl 0. 9%, jew fil - grupp ta ’ kontroll tal- mikrosferi li jġorru d- doża.
The mechanism underlying the renal tumours in RISPERDAL CONSTA-treated male Wistar (Hannover) rats is unknown.
Il- bażi tal- mekkaniżmu tat- tumuri renali f’ firien irġiel Wistar (Hannover) ikkurati b’ RISPERDAL CONSTA m’ huwiex magħruf.
A treatment-related increase in renal tumour incidence did not occur in the oral carcinogenicity studies with Wistar (Wiga) rats or in Swiss mice administered oral risperidone.
Żieda fl- inċidenza ta ’ tumuri renali relatati mal- kura ma seħħitx fi studji ta ’ karċinoġeniċità orali f’ firien Wistar (Wiga) jew fi ġrieden Svizzeri meta ngħataw risperidone mill- ħalq.
Studies conducted to explore the substrain differences in the tumour organ profile suggest that the Wistar (Hannover) substrain employed in the carcinogenicity study differs substantially from the Wistar (Wiga) substrain employed in the oral carcinogenicity study with respect to spontaneous age-related non-neoplastic renal changes, serum prolactin increases, and renal changes in response to risperidone.
Studji magħmula biex jesploraw differenzi fil - profil ta ’ t- tumur ta ’ l- organu jissuġġerixxu li is- sottorazza Wistar (Hannover) li ntużat fl- istudju ta ’ karċinoġenità hija sostanzjalment differenti mis- sottorazza Wistar (Wiga) użata fl- istudju ta ’ karċinoġenità orali fil- każ ta ’ tibdiliet renali spontanji mhux neoplstiċi relatati ma ’ l- età, żieda fil - prolactin tas- serum, u tibdiliet renali bħala rispons għal risperidone.
There are no data suggesting kidney-related changes in dogs treated chronically with RISPERDAL CONSTA.
M’ hemmx dejta li tissuġġerixxi bidliet relatati mal- kliewi fil- klieb ikkurati kronikament b ’ RISPERDAL CONSTA.
The relevance of the osteodystrophy, the prolactin-mediated tumours and of the presumed rat substrain-specific renal tumours in terms of human risk is unknown.
Ir- rilevanza ta ’ l- osteodistrofija, it- tumuri medjati mill- prolactin u t- tumuri renali maħsuba li huma speċifiċi għas- sottorazza tal- firien, f’ termini ta ’ riskju għall- bniedem, m’ hix magħrufa.
Local irritation at the injection site in dogs and rats was observed after administration of high doses of RISPERDAL CONSTA.
Irritazzjoni lokali fis- sit ta ’ l- injezzjoni fil- klieb u l- firien kienet osservata wara għoti ta ’ dożi għolja ta ’ RISPERDAL CONSTA..
In a 24-month intramuscular carcinogenicity study in rats, no increased incidence of injection site tumours was seen in either the vehicle or active groups.
Fi studju ta ’ 24 xahar ta ’ karċinoġeniċità fil- firien, l- ebda żieda fl - inċidenza ta ’ tumuri fis- sit ta ’ l- injezzjoni ma deher kemm fil- gruppi attivi kif ukoll fil- gruppi tas - sustanza mingħajr mediċina.
In vitro and in vivo, animal models show that at high doses risperidone may cause QT interval prolongation, which has been associated with a theoretically increased risk of torsade de pointes in patients.
In vitro u in vivo, annimali mudelli juru li f’ dożi għoljin risperidone jista ’ jikkawża tul ta ’ l- intervall QT, li huwa assoċjat ma ’ żieda fir- riskju teoretiku ta ’ torsades de pointes fil- pazjenti.
[To be completed nationally]
35 [Biex timtela mill- pajjiż partikolari]
34 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta’ dak li hemm ġo fih
6.6 Special precautions for disposal and other handling Instructions for Three Needle System
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal- immaniġġar ieħor Struzzjonijiet għas- Sistema bi Tliet Labriet
RISPERDAL CONSTA extended release microspheres in the vial must be reconstituted only in the solvent in the syringe supplied in the dose pack, and must be administered only with the Needle-Pro safety needle supplied in the dose pack.
Mikrosferi RISPERDAL CONSTA li jintreħew bil- mod li qegħdin fil- kunjett għandhom jiġu rikostitwiti biss fis- solvent ta ’ ġos- siringa pprovduta fil- pakkett tad- doża, u għandu jingħata biss bil - labra ta ’ sigurtà Needle- Pro pprovduta fil- pakkett tad- doża.
Do not substitute any components in the dose pack.
Tissosstwixxix xi komponent mill- pakkett tad- doża.
To assure that the intended dose of risperidone is delivered, the full contents from the vial must be administered.
Biex tiżgura li d- doża intenzjonata ta ’ risperidone ingħatat kollha, għandu jingħata l - kontenut sħih tal- kunjett.
Administration of partial contents may not deliver the intended dose of risperidone.
L- għoti ta ’ parti mill- kontenut tal- kunjett jista ’ ma jagħtix id- doża intenzjonata ta ’ risperidone.
Remove the dose pack of RISPERDAL CONSTA from the refrigerator and allow it to come to room temperature prior to reconstitution.
Neħħi l- pakkett tad- doża ta ’ RISPERDAL CONSTA mill- friġġ u ħallih sakemm jilħaq it- temperatura tal- kamra qabel ir- rikostituzzjoni.
Contents of the dose pack:
Kontenut tal- pakkett tad- doża:
• One vial containing RISPERDAL CONSTA extended release microspheres • Two Hypoint 20G 2” TW needles for reconstitution • One prefilled syringe containing the solvent for RISPERDAL CONSTA • One Needle-Pro needle for intramuscular injection (safety 20G 2” TW needle with needle protection device)
• Kunjett wieħed li fih mikrosferi ta ’ RISPERDAL CONSTA li jintreħew bil- mod • Żewġ labriet Hypoint 20G 2 "TW għar- rikostituzzjoni • Siringa waħda mimlija għal- lest li fiha s- solvent għal RISPERDAL CONSTA • Labra Needle- Pro waħda għall- injezzjoni ġol- muskolu (labra ta ’ sigurtà 20G 2" TW b’ apparat ta ’ protezzjoni għal- labra)
Flip off the plastic coloured cap from the vial.
36 Għatu
Open the prefilled syringe by breaking the seal of the closure and remove the white cap together with the rubber tip cap inside.
Tapp abjad
Open the cover of one reconstitution needle.
Iftaħ it- tgeżwira ta ’ labra waħda tar- rikostituzzjoni.
Keeping the syringe and needle aligned, attach the needle with an easy clockwise twisting motion to the luer connection of the syringe.
Filwaqt li żżomm is- siringa u l- labra bi dritt xulxin, waħħal il- labra, billi ddawwar lejn il- lemin b’ ċaqliqa ħafifa, mal- konnessjoni luer tas- siringa.
Pull sheath away from the needle – do not twist.
Iġbed l- għant minn madwar il- labra – iddawwarx.
Inject the entire contents (solvent) of the syringe into the vial.
Injetta l- kontenut kollu (solvent) tas- siringa fil- kunjett.
Withdraw the syringe with the reconstitution needle from the vial.
Iġbed is- siringa bil- labra tar- rikostituzzjoni l- barra mill- kunjett.
Unscrew the needle from the syringe and discard the needle appropriately.
Ħoll il- labra minn mas- siringa u armi l- labra kif xieraq.
Open the cover of the second reconstitution needle.
Iftaħ it- tgeżwira tat- tieni labra ta ’ rikostituzzjoni.
Keeping the empty syringe and needle aligned, attach the second needle with an easy clockwise twisting motion to the luer connection of the syringe.
Filwaqt li żżomm is- siringa u l- labra bi dritt xulxin, waħħal it- tieni labra, billi ddawwar lejn il - lemin b’ ċaqliqa ħafifa, mal- konnessjoni luer tas- siringa.
Do not remove the sheath from the needle at this time.
Tneħħix l- għant minn madwar il- labra għalissa.
Shake the vial vigorously for at least 10 seconds until obtaining a homogeneous suspension.
Ħawwad il- kunjett bis- saħħa għal mill- anqas 10 sekondi sakemm ikollok suspensjoni omoġena.
Mixing is complete when the suspension appears uniform, thick, and milky in colour, and all the powder is fully dispersed.
It- taħlit ikun komplut meta s- suspensjoni tidher uniformi, magħquda u kulur il- ħalib u t- trab kollu jkun xtered kompletament fit- taħlita.
DO NOT STORE THE VIAL AFTER RECONSTITUTION OR THE SUSPENSION MAY SETTLE.
TAĦŻINX IL- KUNJETT WARA R- RIKOSTITUZZJONI GĦAX INKELLA IS - SUSPENSJONI TISTA ’ TISSEPARA U T- TRAB JINŻEL FIL- QIEGĦ.
Take the syringe and pull sheath away from the reconstitution needle – do not twist.
Ħu s- siringa u iġbed l- għant minn madwar il- labra ta ’ rikostituzzjoni – iddawwarx.
Insert the reconstitution needle into the upright vial.
Daħħal il- labra ta ’ rikostituzzjoni fil- kunjett wieqaf.
Slowly withdraw the suspension from the vial in an upright, but slightly angled position as indicated in the picture to ensure that the entire contents are drawn up into the syringe.
Bil- mod iġbed is- suspensjoni mill- kunjett li jinżamm wieqaf iżda ftit angolat kif indikat fl - istampa biex tiżgura li l- kontenut kollu nġibed għal ġos- siringa.
For identification purposes, tear section of the vial label at the perforation and apply detached section to the syringe.
Għal skopijiet ta ’ identifikazzjoni, qatta parti mit- tikketta tal- kunjett minn fejn hemm it- toqob żgħar u waħħal il- parti mqatta ’ mas- siringa.
Discard the vial appropriately.
Armi il- kunjett kif xieraq.
Peel the blister pouch of the Needle-Pro device open half way.
Qaxxar il- folja forma ta ’ borża ta ’ l- apparat Needle- Pro sa nofsha.
Grasp sheath using the plastic peel pouch.
Aqbad l- għant tal- labra billi tuża l- borża tal- plastik li titqaxxar.
Attach the luer connection of the Needle-Pro device with an easy clockwise twisting motion to the syringe.
Waħħal il- konnessjoni luer ta ’ l- apparat Needle- Pro mas- siringa billi ddawwar b’ ċaqliqa ħafifa lejn il- lemin.