qanastek/EMEA-V3 huggingface dataset:
Other medicinal products or herbals which are inducers, e. g. rifampicin and St John´s wort (Hypericum perforatum) may have similar effects on paliperidone.
John’ s Wort (Hypericum perforatum) jista ’ jkollhom effetti simili fuq paliperidone.
Medicinal products affecting gastrointestinal transit time may affect the absorption of paliperidone, e. g., metoclopramide.
Prodotti mediċinali li jaffettwaw iż- żmien ta ’ tranżitu gastrointestinali jistgħu jaffettwaw l- assorbiment ta ’ paliperidone, e. ż. metoclopramide.
Concomitant use of INVEGA with risperidone Concomitant use of INVEGA with oral risperidone is not recommended as paliperidone is the active metabolite of risperidone and the combination of the two may lead to additive paliperidone exposure.
L- użu konkomitanti ta ’ INVEGA ma ’ risperidone L- użu konkomitanti ta ’ INVEGA ma ’ risperidone li jittieħed mill- ħalq mhux rakkomandat għaliex paliperidone huwa l- metabolit attiv ta ’ risperidone u meta t- tnejn jiġu kkombinati jista ’ jkun hemm espożizzjoni miżjuda ta ’ paliperidone.
There are no adequate data from the use of paliperidone during pregnancy.
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ paliperidone waqt it- tqala.
Paliperidone was not teratogenic in animal studies, but other types of reproductive toxicity were observed (see section 5.3).
Palipedirone ma kienx teratoġeniku fi studji fuq l- annimali, imma ġew osservati forom oħra ta ’ tossiċità fir- riproduzzjoni (ara sezzjoni 5. 3).
The use of antipsychotics during the last trimester of pregnancy has resulted in long term but reversible neurological disturbances of extrapyramidal nature in the infant.
L- użu ta ’ antipsikotiċi waqt l- aħħar trimestru tat- tqala wassal għal disturbi newroloġiċi fit- tul imma li kienu reversibbli ta ’ natura ekstrapiramidali fit- trabi.
INVEGA should not be used during pregnancy unless clearly necessary.
INVEGA m’ għandux jintuża waqt it- tqala sakemm mhux strettament neċessarju.
If discontinuation during pregnancy is necessary, it should not be done abruptly.
Jekk ikun hemm bżonn li jitwaqqaf waqt it- tqala, dan m’ għandux isir f’ daqqa.
Paliperidone is excreted in the breast milk to such an extent that effects on the breast-fed infant are likely if therapeutic doses are administered to breast-feeding women.
Paliperidone jiġi eskretat mal- ħalib tas- sider tant li aktarx li jaffettwa t- trabi mredda jekk jingħataw dożi terapewtiċi lil nisa li qed ireddgħu.
INVEGA should not be used while breast feeding.
INVEGA m’ għandux jintuża waqt it- treddigħ.
Paliperidone can have minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects (see section 4.8).
Palipedirone jista ’ jkollu effett żgħir jew moderat fuq il- ħila ta 'sewqan u l- użu ta ’ magni minħabba l - effetti potenzjali fuq is- sistema nervuża u l- vista (ara sezzjoni 4. 8).
Therefore, patients should be advised not to drive or operate machines until their individual susceptibility to INVEGA is known.
Għalhekk il- pazjenti għandhom jingħataw il- parir li ma jsuqux u ma jħaddmux makkinarju sakemm tkun magħrufa s- suxxettibilita` individwali tagħhom għal INVEGA.
The most frequently reported adverse drug reactions (ADRs) reported in clinical trials were headache, tachycardia, akathisia, sinus tachycardia, extrapyramidal disorder, somnolence, dizziness, sedation, tremor, hypertonia, dystonia, orthostatic hypotension, and dry mouth.
Fi provi kliniċi l- iktar reazzjonijiet avversi għall- mediċina li ġew irrapurtati b’ mod frekwenti (ADRs) kienu uġigħ ta ’ ras, takikardja, akatisja, sinus takikardja, mard ekstrapiramidali, ħedla, sturdament, sedazzjoni, rogħda, ipertonja, distonja, ipotensjoni ortostatika, u nixfa tal- ħalq.
The ADRs that appeared to be dose-related included weight increased, headache, salivary hypersecretion, vomiting, dyskinesia, akathisia, dystonia, extrapyramidal disorder, hypertonia, and Parkinsonism.
L- ADRs li dehru li kienu marbuta mad- doża kienu jinkludu żieda fil- piż, uġigħ ta ’ ras, ipersekrezzjoni tas- saliva, rimettar, diskajneżja, akatisja, distonja, disturbi ekstrapiramidali, ipertonja u l - Parkinsoniżmu.
The following are all ADRs that were reported in INVEGA-treated subjects in clinical trials.
Dawn li li ġejjin kienu kollha ADRs li ġew irrapurtarti f’ suġġetti kkurati bi INVEGA fi provi kliniċi.
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/ 1000), and very rare (< 1/ 10,000).
Jintużaw dawn it- termini u frekwenzi: komuni ħafna (≥ 1/ 10), komuni (≥ 1/ 100 sa < 1/ 10), mhux komuni (≥ 1/ 1000 sa < 1/ 100), rari (≥ 1/ 10, 000 sa < 1/ 1000), u rari ħafna (< 1/ 10, 000).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skond is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
6 System Organ Class
6 Klassifikazzjoni tas - Sistema ta ’ l- Organi Disturbi fis- sistema immuni
Very common
Komuni Ħafna
Immune system disorders
Reazzjoni Avversa għall- Mediċina Frekwenza Komuni Mhux Komuni reazzjoni anafilattika
increased appetite
żieda fl- aptit
nightmare
Ħmar il- lejl
extrapyramidal disorder, parkinsonism, tremor, hypertonia, dystonia, akathisia, dizziness, sedation, somnolence,
mard ekstrapiramidali, parkinsoniżmu, rogħda, ipertonja, distonja, akatisja, sturdament, sedazzjoni, ħedla,
grand mal convulsion, syncope, dyskinesia, dizziness postural
konvulżjonijiet tal- grand mal, sinkope, diskajneżja, sturdament skond il - pożizzjoni,
oculogyration
tidwir ta ’ l- għajn
tachycardia, sinus tachycardia, bundle branch block, atrioventricular block first degree, bradycardia
takikardja, sinus takikardja, imblokkar ta ’ bundle branch, imblukkar atrijoventrikulari ta ’ l - ewwel grad, bradikardja,
palpitations, sinus arrhythmia
palpitazzjonijiet, sinus arritmija
Vascular disorders Gastrointestinal disorders
Disturbi vaskulari Disturbi gastro - intestinali
orthostatic hypotension vomiting, abdominal pain upper, salivary hypersecretion, dry mouth,
ipotensjoni ortostatika rimettar, uġigħ fil- parti addominali ta ’ fuq, ipersekrezzjoni salivari, nixfa fil- ħalq,
ischaemia, hypotension,
Iskemija, ipotensjoni,
Musculoskeletal, connective tissue and bone disorders
Disturbi muskolu - skeletrali, tal - connective tissue u ta ’ l- għadam.
muscle rigidity
riġidità muskolari
amenorrhoea, galactorrhoea, erectile dysfunction, gynaecomastia, breast discharge, menstruation irregular
amenorrea, galactorea, nuqqas ta ’ erezzjoni normali, ġinekomastija, tnixxija mis- sider, mestrwazzjoni irregulari,
General disorders Investigations
Disturbi ġenerali
asthenia, fatigue weight increased
astenja, għeja żieda fil- piż
oedema electrocardiogram abnormal
elettrokardjogramma mhux normali
Paliperidone is an active metabolite of risperidone.
Paliperidone huwa metabolit attiv ta ’ risperidone.
The following is a list of additional ADRs that have been reported with risperidone.
Il- lista li ġejja hija ta ’ ADRs addizzjonali li ġew irrapurati b’ risperidone.
System Organ Class Infections and infestations
Klassifikazzjoni Reazzjoni Avversa għall- Mediċina Sistematika ta ’ l- Organi Infezzjonijiet u infestazzjonijiet
Adverse Drug Reaction acarodermatitis, bronchitis, bronchopneumonia, cellulitis, cystitis, ear infection, eye infection, influenza, localised infection, nasopharyngitis, onychomycosis, otitis media, otitis media chronic, pharyngitis, pneumonia, respiratory tract infection, rhinitis, sinusitis, tonsillitis, tracheobronchitis, upper respiratory tract infection, urinary tract infection, viral infection
akarodermatite, bronkite, bronkopulmonite, ċellulite, ċistite, infezzjoni fil- widna, infezzjoni fil- għajn, influwenza, infezzjoni lokalizzata, nasofarinġite, onikomikożi, otite medja, otite medja kronika, farinġite, pulmonite, infezzjoni tal- passaġġ respiratorju, rinite, sinużite, tonsillite, trakeobronkite, infezzjoni tal- passaġġ respiratorju ta ’ fuq, infezzjoni tal - passaġġ urinarju, infezzjoni virali
anaemia, granulocytopenia, neutropenia, thrombocytopenia
anemija, granuloċitopenija, newtropenija, tromboċitopenija
Immune system disorders drug hypersensitivity, hypersensitivity Endocrine disorders
Disturbi fis- sistema immuni Disturbi fis- sistema endokrinarja
hyperprolactaemia, inappropriate antidiuretic hormone secretion
Disturbi fil- metaboliżmu u n- nutrizzjoni
Metabolism and nutrition anorexia, decreased appetite, diabetic ketoacidosis, polydipsia disorders Psychiatric disorders
Disturbi psikjatriċi
agitation, anorgasmia, anxiety, blunted affect, confusional state, insomnia, libido decreased, listless, mania, middle insomnia, nervousness, restlessness, sleep disorder 7
aġitazzjoni, anorgażmija, ansjetà, effett ‘ blunted ’, stat konfużjonali, insomnja, tnaqqis tal- libido, mitluq, manija, insomnja mezzana, nervożiżmu, bla kwiet, disturbi fl- irqad.
Nervous system disorders akinesia, balance disorder, bradykinesia, cerebral ischaemia, cerebrovascular accident, cerebrovascular disorder, cogwheel rigidity, convulsion, coordination abnormal, depressed level of consciousness, diabetic coma, disturbance in attention, drooling, dysarthria, hypersomnia, hypoaesthesia, hypokinesia, lethargy, loss of consciousness, masked facies, movement disorder, muscle contractions involuntary, neuroleptic malignant syndrome, parkinsonian rest tremor, speech disorder, tardive dyskinesia, transit ischaemic attack, unresponsive to stimuli Eye disorders
Disturbi fis- sistema nervuża akineżja, disturbi bil- bilanċ, bradikinesija, iskemija ċerebrali, aċċident ċerebrovaskulari, diżordni ċerebrovaskulari, riġidità bħal tar- roti f’ magna, konvulżjoni, koordinazzjoni anormali, livell imnaqqas ta ’ kuxjenza, koma dijabetika, disturbi fl- attenzjoni, tlegħib, disartrija, ipersomnja, ipoesteżja, ipokineżja, letarġija, telf tas- sensi, espressjoni tal- wiċċ bħal maskra, disturbi fil- moviment, kontrazzjonijiet muskolari involontarji, sindromu newrolettiku malinn, tregħid parkinsonjan, disturbi fit- taħdit, diskajneżja tardiva, attakk iskemiku transitorju, ma jirrispondix għal stimoli Disturbi fl- għajnejn
conjunctivitis, dry eye, eye discharge, eye rolling, eye swelling, eyelid margin crusting, eyelid oedema, glaucoma, lacrimation increased, ocular hyperaemia, photophobia, vision blurred, visual acuity reduced
konġuntivite, għajnejn nixfin, għajnejn iħammġu, għajnejn iduru, għajnejn minfuħa, frak fit- tarf tal- kappell tal- għajn, edema tal- kappell tal - għajn, glawkoma, żieda fid- demgħat, iperemija okulari, fotofobja, vista mċajpra, tara inqas ċar
ear pain, tinnitus
uġigħ fil- widnejn, żanżin tal- widnejn
Cardiac disorders Vascular disorders
Disturbi fil- qalb Disturbi vaskulari
atrial fibrillation, atrioventricular block flushing
fibrillazzjoni atrijali, imblokk atrijoventrikulari ħmura fil- wiċċ
Respiratory, thoracic and cough, dysphonia, dyspnoea, epistaxis, hyperventilation, nasal mediastinal disorders
Disturbi respiratorji, toraċiċi tqaħqiħ, disfonija, dispnea, epistażi, iperventilazzjoni, konġestjoni nażali, u medjastinali
congestion, nasal oedema, pharyngolaryngeal pain, pneumonia aspiration, productive cough, pulmonary congestion, rales, respiratory disorder, respiratory tract congestion, rhinorrhoea, sinus congestion, sleep apnoea syndrome, wheezing
edema nażali, uġigħ faringolarinġali, aspirazzjoni tal- pulmonite, tqaħqiħ produttiv, konġestjoni pulmonari, ħsejjes tal- pulmun, disturbi respiratorji, konġestjoni tal- passaġġ respiratorju, rinorrea, konġestjoni tas- sinus, sindromu ta ’ apnea ta ’ l- irqad, tħarħir
abdominal discomfort, abdominal pain, aptyalism, cheilitis, constipation, diarrhoea, dyspepsia, dysphagia, faecal incontinence, faecaloma, gastritis, intestinal obstruction, lip swelling, nausea, stomach discomfort
skumdità addominali, uġigħ addominali, aptjaliżmu, kejlite, stitikezza, dijarea, dispepsja, disfaġja, inkontinenza ta ’ l- ippurgar, fekaloma, gastrite, ostruzzjoni intestinali, xoffa minfuħa, nawżja, skumdità fl - istonku
Hepatobiliary disorders jaundice Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
acne, angioneurotic oedema, dandruff, dry skin, erythema, hyperkeratosis, pruritus, rash, rash erythematous, rash generalised, rash maculo-papular, rash papular, seborrhoeic dermatitis, skin discolouration, skin disorder, skin lesion
akne, edema anġjonewrotika, brijja, ġilda niexfa, eritema, iperkeratożi, ħakk, raxx, raxx eritematiku, raxx ġeneralizzat, raxx makulo- papulari, raxx papulari, dermatite seborrojka, bidla fil- kulur tal- ġilda, disturbi tal - ġilda, feriti fil- ġilda
Musculoskeletal and connective tissue disorders
Disturbi muskolu- skeltrali u artralġja, uġigħ fid- dahar, ebusija tal- ġogi, spażmi fil- muskoli, tiġbid tal - tal- connective tissue
arthralgia, back pain, joint stiffness, muscle spasms, muscle twitching, muscular weakness, musculoskeletal chest pain, musculoskeletal stiffness, myalgia, neck pain, pain in extremity, posture abnormal, rhabdomyolysis, torticollis
muskolu, dgħjufija fil- muskolu, uġigħ muskoloskeletali fis- sider, ebusija muskoloskeletali, majalġja, uġigħ fil- għonq, uġigħ fl- estremitajiet, pożizzjoni mhux normali, rabdomajolożi, tortikollite
dysuria, enuresis, pollakiuria, urinary incontinence
disurja, enuresi, pollakjurja, inkontinenza urinarja
Reproductive system and breast enlargement, ejaculation disorder, ejaculation failure, breast disorders
Disturbi fis- sistema riproduttiva u fis- sider
menstrual disorder, priapism, retrograde ejaculation, sexual dysfunction, vaginal discharge
tkabbir tas- sider, disturbi fl- eġakulazzjoni, insuffiċjenza fl- eġakulazzjoni, disturbi mestrwali, priapiżmu, eġakulazzjoni retrograda, disfunzjoni sesswali, tnixxija vaġinali
General disorders
Disturbi ġenerali
adverse drug reaction, chest discomfort, chest pain, chills, discomfort, drug withdrawal syndrome, face oedema, feeling abnormal, gait disturbance, generalized oedema, influenza like illness, malaise, oedema peripheral, peripheral coldness, pitting oedema, pyrexia, sluggishness, thirst
reazzjoni avversa għall- mediċina, skumdità fis- sider, uġigħ fis- sider, kesħa, skumdità, sindromu ta ’ twaqqif tal- mediċina, edema tal- wiċċ, ma tħossokx normali, disturbi fil- mixja, edema ġeneralizzata, mard bħal influwenza, sensazzjoni ġenerali ta ’ mard, edema periferali, bard periferali, edema bl- iffossar, deni, telqa, għatx
8 Elderly In a study conducted in elderly subjects with schizophrenia, the safety profile was similar to that seen in non-elderly subjects.
8 Investigazzjonijiet
INVEGA has not been studied in elderly patients with dementia.
INVEGA ma ġiex studjat f’ pazjenti anzjani b’ dimenzja.
In clinical trials with some other atypical antipsychotics, increased risks of death and cerebrovascular accidents have been reported (see section 4.4).
Fi provi kliniċi b’ xi antipsikotiċi atipiċi oħrajn, ġew irrapurati riskji miżjuda ta ’ mewt u inċidenti ċerebrovaskulari (ara sezzjoni 4. 4).
Events of Particular interest to the class
Avvenimenti ta ’ interess partikolari għal din il- klassi
Extrapyramidal Symptoms (EPS).
Sintomi ekstrapiramidali (EPS).
In clinical trials, there was no difference observed between placebo and the 3 and 6 mg doses of INVEGA.
Fi provi kliniċi, ma ġietx osservata differenza bejn il- plaċebo u dożi ta ’ 3 mg u 6 mg ta ’ INVEGA.
EPS included a pooled analysis of the following terms: dyskinesia, dystonia, hyperkinesia, Parkinsonism, and tremor.
Ġiet osservata rabta bid- doża għall- EPS maż- żewġ dożi ogħla ta ’ INVEGA (9 u 12- il mg) L- EPS kienu jinkludu analiżi miġbura tas- segwenti it- termini: diskajneżja, distonja, iperkajneżja, Parkinsoniżmu u rogħda.
Weight Gain.
Żieda fil- piż.
In clinical trials, the proportions of subjects meeting a weight gain criterion of ≥ 7% of body weight were compared, revealing a similar incidence of weight gain for INVEGA 3 mg and 6 mg compared with placebo, and a higher incidence of weight gain for INVEGA 9 mg and 12 mg compared with placebo.
Fi provi kliniċi, tqabblu l- proporzjon ta ’ suġġetti li laħqu l- kriterju ta ’ żieda fil- piż ta ’ ≥ 7% tal- piż tal- ġisem, u dan wera żieda simili fil- piż għal INVEGA tat- 3 mg u tas- 6 mg meta mqabbla mal- plaċebo, u inċidenza ogħla ta ’ żieda fil- piż għal INVEGA tad- 9 mg u tat- 12- il mg meta mqabbla mal- plaċebo.
Laboratory Tests:
Testijiet fil- laboratorju:
Serum Prolactin.
Prolaktin fis- serum..
In clinical trials, median increases in serum prolactin were observed with INVEGA in 67% of subjects.
Fi provi kliniċi, kienu osservati żidiet medji fis- serum prolaktin bi INVEGA f’ 67% tas- suġġetti.
Adverse events that may suggest increase in prolactin levels (e. g., amenorrhoea, galactorrhoea, gynaecomastia) were reported overall in 2% of subjects.
Ġew irrapurtati avvenimenti avversi li potenzjalment huma marbuta ma ’ żieda fil- prolaktin (e. ż. amenorrea, galactorrea, ġinekomastija) b’ mod ġenerali ma ’ 2% tal- pazjenti.
Maximum mean increases of serum prolactin concentrations were generally observed on Day 15 of treatment, but remained above baseline levels at study endpoint.
Żidiet massimi tal- medja ta ’ konċentrazzjoni ta ’ prolaktin fis- serum ġeneralment kienu osservati f’ Jum 15 tal- kura, imma baqgħu ogħla mill- livelli bażi fl- aħħar ta ’ l- istudji.
Class effects QT prolongation, ventricular arrythmias (ventricular fibrillation, ventricular tachycardia), sudden unexplained death, cardiac arrest and Torsade de pointes may occur with antipsychotics.
Effetti tal- klassi B’ antipsikotiċi jista ’ jkun hemm prolongazzjoni tal- QT, arritmiji ventrikulari (fibrillazzjoni ventrikulari, takikardja ventrikulari), mewt f’ daqqa bla spjegazzjoni, attakk tal- qalb u Torsade de pointes.
In general, expected signs and symptoms are those resulting from an exaggeration of paliperidone’ s known pharmacological effects, i. e., drowsiness and sedation, tachycardia and hypotension, QT prolongation, and extrapyramidal symptoms.
B’ mod ġenerali is- sinjali u s- sintomi li wieħed jistenna huma dawk li jiġu minn esaġerazzjoni ta ’ l - effetti farmakoloġiċi magħrufa ta ’ Paliperidone, jiġifieri ħedla u sedazzjoni, takikardja u ipotensjoni, prolongazzjoni tal- QT, u sintomi ekstrapiramidali.
In the case of acute overdosage, the possibility of multiple medicinal product involvement should be considered.
Fil- każ ta ’ doża eċċessiva akuta għandha tiġi kkunsidrata l- possibiltà ta ’ l- involviment ta ’ iktar minn prodott mediċinali wieħed.
Consideration should be given to the prolonged-release nature of the product when assessing treatment needs and recovery.
Meta wieħed iqis il- kura meħtieġa u l- fejqan, għandha tingħata konsiderazzjoni għan- natura tal - prodott li terħi l- mediċina bil- mod.
There is no specific antidote to paliperidone.
M’ hemmx antidotu speċifiku għal paliperidone.
General supportive measures should be employed.
Għandhom jintużaw miżuri ġenerali ta ’ appoġġ.
Establish and maintain a clear airway and ensure adequate oxygenation and ventilation.
Il- passaġġ ta ’ l- arja għandu jitbattal u jinżamm miftuħ, u għandha tiġi assigurata ossiġenazzjoni u ventilazzjoni adegwata.
Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring for possible arrhythmias.
Il- monitoraġġ kardjovaskulari għandu jibda mill- ewwel u għandu jinkludi monitoraġġ kontinwu elettrokardjografiku għall- possibilità ta ’ arritmiji.
Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluid and/ or sympathomimetic agents.
L- ipotensjoni u l- kollass ċirkulatorju għandhom jiġu kkurati b’ miżuri xierqa bħal fluwidu fil- vina u/ jew aġenti simpatomimetiċi.
Gastric lavage (after intubation if the patient is unconscious) and administration of activated charcoal together with a laxative should be considered.
Għandu jiġi kkunsidrat lavaġġ gastriku (wara l- intubazzjoni jekk il - pazjent hu mitluf minn sensih) u l- amministrazzjoni ta ’ faħam tal- kannol attivat flimkien ma ’ lassativ.
In case of severe extrapyramidal symptoms, anticholinergic agents should be administered.
Fil- każ ta ’ sintomi extrapiramidali qawwija, għandhom jingħataw aġenti antikolinerġiċi.
Close supervision and monitoring should continue until the patient recovers.
Għandu jkun hemm superviżjoni u monitoraġġ stretti sakemm il- pazjent jistejqer.
5.1 Pharmacodynamic properties
9 5. 1 Tagħrif farmakodinamiku
Pharmacologic group: other antipsychotics ATC code:
Kategorija farmakoterapewtika: antipsikotiċi oħra Kodiċi ATC:
INVEGA contains a racemic mixture of (+)- and (-)-paliperidone.
INVEGA fih taħlita raċemika ta ’ (+) - u (-) - paliperidone.
9 Mechanism of Action Paliperidone is a selective blocking agent of monoamine effects, whose pharmacological properties are different from that of traditional neuroleptics.
Mekkaniżmu ta ’ Azzjoni Paliperidone huwa aġent li jimblokka b’ mod selettiv l- effetti monoamini, li l- propjetajiet farmakoloġiċi tagħhom huma differenti minn dawk ta ’ newrolettiċi tradizzjonali.
Paliperidone binds strongly to serotonergic 5-HT2- and dopaminergic D2-receptors.
Paliperidone jintrabat b’ mod qawwi mar- riċetturi ta ’ 5- HT2 - serotonerġiċi u D2 dopaminerġiċi.
Paliperidone also blocks alfa1-adrenergic receptors and blocks, to a lesser extent, H1-histaminergic and alfa2-adrenergic receptors.
Paliperidone jimblokka wkoll riċetturi alfa1- adrenerġiċi u jimblokka, inqas, riċetturi istaminerġiċi H1 u adrenerġiċi alfa2.
The pharmacological activity of the (+)- and (-)- paliperidone enantiomers are qualitatively and quantitatively similar.
L- attività farmakoloġika ta ’ enantjomeri (+) - u (-) - ta ’ paliperidone hija simili mill- aspetti kemm kwalitattivi kif ukoll kwantitattivi.
Paliperidone is not bound to cholinergic receptors.
Paliperidone mhux marbut ma ’ riċetturi kolinerġiċi.
Even though paliperidone is a strong D2-antagonist, which is believed to relieve the positive symptoms of schizophrenia, it causes less catalepsy and decreases motor functions to a lesser extent than traditional neuroleptics.
Għalkemm paliperidone huwa antagonista D2 qawwi, li hi maħsuba li ttaffi s- sintomi pożittivi ta ’ l- iskizzofrenija, tikkawża inqas katalessi u tnaqqas il- funzjonijiet motorji inqas meta mqabbel ma ’ newtrolettiċi tradizzjonali.
Dominating central serotonin antagonism may reduce the tendency of paliperidone to cause extrapyramidal side effects.
Il- ħila li tiddomina l - antagoniżmu b’ mod ċentrali tas- serotonin jista ’ jnaqqas it- tendenza ta ’ paliperidone li jikkawża l - effetti ekstrapiramidali mhux mixtieqa.
Pharmacodynamic Effects
Effetti farmakodinamiċi
Clinical Efficacy The efficacy of INVEGA was established in three multi-centre, placebo-controlled, double-blind, 6-week trials in subjects who met DSM-IV criteria for schizophrenia.
Effikaċja klinika L- effikaċja ta ’ INVEGA kienet stabbilita fi tliet provi b’ ċentri differenti, ikkontrollati bil- plaċebo u ‘ double- blind ’ li damu 6 ġimgħat f’ suġġetti li kienu jissodisfaw il- kriterji DSM- IV għal skiżofrenja.
INVEGA doses, which varied across the three studies, ranged from 3 to 15 mg once daily.
Id- dożi ta ’ INVEGA, li kienu jvarjaw fit- tliet studji, kienu bejn 3 u 15- il mg darba kuljum.
The primary efficacy endpoint was defined as a decrease in total Positive and Negative Syndrome Scale (PANSS) scores as shown in the following table.
Il- kejl aħħari primarju ta ’ effiċjenza kien iddefinit bħala t- tnaqqis fit- totali ta ’ Skala tas- Sindromi Pożittivi u Negattivi (PANSS) kif muri fit- tabella li ġejja.
All tested doses of INVEGA separated from placebo on day 4 (p < 0.05).
Id- dożi kollha ttestjati ta ’ INVEGA ġew isseparati mill- plaċebo f’ jum 4 (p < 0. 05).
Predefined secondary endpoints included the Personal and Social Performance (PSP) scale and the Clinical Global Impression – Severity (CGI-S) scale.
Kejlijiet aħħarija sekondarji li kienu definiti minn qabel kienu jinkludu l- iskala ta ’ l- Imġieba Personali u Soċjali (PSP) u l- iskala ta ’ l- Impressjoni Klinika Globali – Severità (CGI- S).
In all three studies, INVEGA was superior to placebo on PSP and CGI-S.
Fit- tlett studji, INVEGA kien superjuri għall- plaċebo mill- aspett ta ’ PSP u CGI- S.
Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score - Change From Baseline to End Point- LOCF for Studies R076477-SCH-303, R076477-SCH-304, and R076477-SCH-305:
Skala ta ’ Sindromi Pożittivi u Negattivi għal skiżofrenja (PANSS) Marka Totali – Bidla mill- Linja Bażi sal - Punt Finali- LOCF għall- istudji R076477- SCH- 303, R076477- SCH- 304, u R076477- SCH- 305:
Intent- to-Treat Analysis Set
Sett ta ’ Analiżi Intenzjoni- biex- Tikkura
Mean baseline (SD) Mean change (SD) P-value (vs, Placebo) Diff. of LS Means (SE)
Plaċebo) Diff. ta ’ Medji LS (SE)
94.1 (10.74) -4.1 (23.16)
94. 1( 10. 74) - 4. 1 (23. 16)
94.3 (10.48) -17.9 (22.23) < 0.001 -13.7 (2.63)
94. 3 (10. 48) - 17. 9 (22. 23) < 0. 001 - 13. 7 (2. 63)
93.2 (11.90) -17.2 (20.23) < 0.001 -13.5 (2.63)
93. 2 (11. 90) - 17. 2 (20. 23) < 0. 001 - 13. 5 (2. 63)
94.6 (10.98) -23.3 (20.12) < 0.001 -18.9 (2.60)
94. 6 (10. 98) - 23. 3 (20. 12) < 0. 001 - 18. 9 (2. 60)
R076477-SCH-304 Mean baseline (SD) Mean change (SD) P-value (vs, Placebo) Diff. of LS Means (SE)
Placebo) Diff. ta ’ Medji LS (SE)
(N=105) 93.6 (11.71) -8.0 (21.48)
93. 6 (11. 71) - 8. 0 (21. 48)
(N=111) 92.3 (11.96) -15.7 (18.89) 0.006 -7.0 (2.36)
92. 3 (11. 96) - 15. 7 (18. 89) 0. 006 - 7. 0 (2. 36)
(N=111) 94.1 (11.42) -17.5 (19.83) < 0.001 -8.5 (2.35)
94. 1 (11. 42) - 17. 5 (19. 83) < 0. 001 - 8. 5 (2. 35)
Mean baseline (SD) Mean change (SD) P-value (vs, Placebo) Diff. of LS Means (SE)
Placebo) Diff. ta ’ Medji LS (SE)
93.9 (12.66) -2.8 (20.89)
93. 9 (12. 66) - 2. 8 (20. 89)
91.6 (12.19) -15.0 (19.61) < 0.001 -11.6 (2.35)
91. 6 (12. 19) - 15. 0 (19. 61) < 0. 001 - 11. 6 (2. 35)
93.9 (13.20) -16.3 (21.81) < 0.001 -12.9 (2.34)
93. 9 (13. 20) - 16. 3 (21. 81) < 0. 001 - 12. 9 (2. 34)
Negative change in score indicates improvement.
Bidla negattiva fil- marka tindika titjib.
For all 3 studies, an active control (olanzapine at a dose of 10 mg) was included.
Għat- 3 studji, ġie inkluż kontroll attiv (olanzapine b’ doża ta ’ 10 mg).
LOCF = last observation carried forward.
LOCF = l- aħħar osservazjoni miġjuba ‘ l quddiem.
The 1-7 version of the PANSS was used.
Intużat il- verżjoni 1- 7 ta ’ PANSS.
A 15 mg dose was also included in Study R076477-SCH-305, but results are not presented since this is above the maximum recommended daily dose of 12 mg.
Doża ta ’ 15- il mg kienet inkluża wkoll fi Studju R076477- SCH- 305, imma r- riżultati mhux ippreżentati billi dan kien ogħla mill- massimu rakkomandat b’ doża ta ’ kuljum ta ’ 12- il mg.
In a long-term trial designed to assess the maintenance of effect, INVEGA was significantly more effective than placebo in maintaining symptom control and delaying relapse of schizophrenia.
Fi prova fit- tul imfassla biex tqis kemm jinżamm l- effett, INVEGA kien iktar effettiv b’ mod sinifikanti mill- plaċebo jinżamm kontroll tas- sintomi u biex jitwal iż- żmien qabel terġa ’ toħroġ l - iskiżofrenja.
After having been treated for an acute episode for 6 weeks and stabilized for an additional 8 weeks with INVEGA (doses ranging from 3 to 15 mg once daily) patients were then randomised in a double-blind manner to either continue on INVEGA or on placebo until they experienced a relapse in schizophrenia
Wara li ġew ikkurati għal episodju akut għal 6 ġimgħat u ġew stabilizzati għal 8 ġimgħat oħra bi INVEGA (id- dożi kienu jvarjaw minn 3 sa 15- il mg darba kuljum) il- pazjenti tqassmu b’ mod randomised bil- metodu ‘ double blind ’ biex jew ikomplu b’ INVEGA jew bi plaċebo sakemm reġgħu ħarġu s- sintomi ta ’ l- iskiżofrenja.
The trial was stopped early for efficacy reasons by showing a significantly longer time to relapse in patients treated with INVEGA compared to placebo (p=0.0053).
Il- prova twaqqfet kmieni għal raġunijiet ta ’ effikaċja billi ntwera li l- pazjenti li kienu fuq INVEGA damu iktar b’ mod sinifikanti biex jirkadu meta mqabbla mal- plaċebo (p=0. 0053).
The pharmacokinetics of paliperidone following INVEGA administration are dose proportional within the available dose range.
Il- farmakokinetika ta ’ paliperidone waqt l- amministrazzjoni ta ’ INVEGA huma proporzjonali għad - doża fil- medda ta ’ doża klinika rakkomandata (3 sa 12- il mg).
Absorption Following a single dose, INVEGA exhibits a gradual ascending release rate, allowing the plasma concentrations of paliperidone to steadily rise to reach peak plasma concentration (Cmax) approximately 24 hours after dosing.
Assorbiment Wara doża waħda, INVEGA għandu rata li biha tintreħa l- mediċina li togħla bil- mod, u dan iħalli l - konċentrazzjonijiet ta ’ paliperidone fil- plażma li jogħlew bil- mod sakemm jilħqu l- ogħla konċentrazzjoni fil- plażma (Cmax) bejn wieħed u ieħor 24 siegħa wara d- doża.
With once-daily dosing of INVEGA, steady-state concentrations of paliperidone are attained within 4-5 days of dosing in most subjects.
B’ doża waħda kuljum ta ’ INVEGA, konċentrazzjonijiet fi stat fiss ta ’ paliperidone jintlaħqu fi żmien 4- 5 ijiem ta ’ dożaġġ fil - maġġoranza tas- suġġetti.
Paliperidone is the active metabolite of risperidone.
Paliperidone huwa l- metabolit attiv ta ’ risperidone.
The release characteristics of INVEGA result in minimal peak-trough fluctuations as compared to those observed with immediate-release risperidone (fluctuation index 38% versus 125%).
Il- karatteristiċi tal- ħruġ ta ’ mediċini ta ’ INVEGA iwasslu għal varjazzjoni minimi bejn l- ogħla punt u l- iktar wieħed baxx meta mqabbla ma ’ dawk osservati b’ risperidone b’ rilaxx immedjat (indiċi ta ’ varjazzjoni ta ’ 38% kontra 125%).
The absolute oral bioavailability of paliperidone following INVEGA administration is 28% (90% CI of 23%-33%).
Il- biodisponibiltà orali assoluta ta ’ paliperidone wara l- amministrazzjoni ta ’ INVEGA hija ta ’ 28% (90% CI ta ’ 23% - 33%).
Administration of paliperidone prolonged-release tablets with a standard high-fat/ high-caloric meal increases Cmax and AUC of paliperidone by up to 50-60% compared with administration in the fasting state.
L- amministrazzjoni ta ’ pilloli ta ’ paliperidone li jerħu l- mediċini bil- mod ma ’ ikla normali b’ livell għoli ta ’ xaħam/ kaloriji jgħolli Cmax u AUC ta ’ paliperidone sa 50- 60% meta mqabbel ma ’ l - amministrazzjoni fi stat ta ’ sawm.
Distribution Paliperidone is rapidly distributed.
11 Paliperidone jiġi distribwit rapidament.
The apparent volume of distribution is 487 l.
Il- volum apparenti ta ’ distribuzzjoni huwa 4871.
The plasma protein binding of paliperidone is 74%.
L- irbit mal - proteina tal- plażma ta ’ paliperidone huwa ta ’ 74%.
It binds primarily to α 1-acid glycoprotein and albumin.
Jintrabat primarjament ma ’ α1- acid glycoprotein u albumina.
Biotransformation and elimination One week following administration of a single oral dose of 1 mg immediate-release 14C-paliperidone, 59% of the dose was excreted unchanged into urine, indicating that paliperidone is not extensively metabolised by the liver.
Bijotrasformazzjoni u eliminazzjoni Ġimgħa wara l- amministrazzjoni ta ’ doża waħda orali ta ’ 1 mg 14C- paliperidone li jerħi l- mediċina b’ mod immedjat, 59% tad- doża tneħħiet bla bdil ma ’ l- awrina, li jindika li paliperidone ma jiġix metabolizzat b’ mod estensiv mil- fwied.
Approximately 80% of the administered radioactivity was recovered in urine and 11% in the faeces.
Bejn wieħed u ieħor 80% tar- radjuattività li ġiet amministrata inġabret mill- urina u 11% fl- ippurgar.
Four metabolic pathways have been identified in vivo, none of which accounted for more than 6.5% of the dose: dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission.
Ġew identifikati erba ’ mogħdijiet metaboliċi in vivo, li l- ebda waħda minnhom ma kienet twassal għal iktar minn 6. 5% tad- doża: dealkilazzjoni, idroksilazzjoni, deidroġenazzjoni, u xizzjoni tal- benzisoxazole.
Although in vitro studies suggested a role for CYP2D6 and CYP3A4 in the metabolism of paliperidone, there is no evidence in vivo that these isozymes play a significant role in the metabolism of paliperidone.
Għalkemm studji in vitro jissuġġerixxu li CYP2D6 u CYP3A4 għandhom sehem fil- metaboliżmu ta ’ paliperidone, m’ hemmx evidenza in vivo li dawn l - isożimi għandhom sehem sinjifikanti fil- metaboliżmu ta ’ paliperidone.
Population pharmacokinetics analyses indicated no discernable difference on the apparent clearance of paliperidone after administration of INVEGA between extensive metabolisers and poor metabolisers of CYP2D6 substrates.
Diversi analiżi tal- karatteristiċi farmakokinetiċi fil- popolazzjoni ma wrew l- ebda differenza fit- tneħħija apparenti ta ’ paliperidone wara l- amministrrazzjoni ta ’ INVEGA bejn metabolizzaturi estensivi u metabolizzaturi mhux tajbin ta ’ sustrati ta ’ CYP2D6.
In vitro studies in human liver microsomes showed that paliperidone does not substantially inhibit the metabolism of medicines metabolised by cytochrome P450 isozymes, including CYP1A2, CYP2A6, CYP2C8/ 9/ 10, CYP2D6, CYP2E1, CYP3A4, and CYP3A5.
CYP2D6, CYP2E1, CYP3A4, u CYP3A5.
The terminal elimination half-life of paliperidone is about 23 hours.
Il- half- life ta ’ l - eliminazzjoni terminali ta ’ paliperidone hija bejn wieħed u ieħor 23 siegħa.
In vitro studies have shown that paliperidone is a P-gp substrate and a weak inhibitor of P-gp at high concentrations.
Studji in vitro urew li paliperidone huwa sustrat ta ’ P- gp u inibitur dgħajjef ta ’ P- gp f’ konċentrazzjonijiet għoljin.
No in vivo data are available and the clinical relevance is unknown.
M’ hemmx tagħrif in vivo disponibbli u r- rilevanza klinika mhix magħrufa.
Hepatic Impairment Paliperidone is not extensively metabolized in the liver.
Indeboliment Epatiku Paliperidone mhux metabolizzat b’ mod estensiv fil- fwied.
In a study in subjects with moderate hepatic impairment (Child-Pugh class B), the plasma concentrations of free paliperidone were similar to those of healthy subjects.
Fi studju f’ suġġetti b’ indeboliment epatiku moderat (Child- Pugh Klassi B), il- konċentrazzjonijiet fil- plażma ta ’ paliperidone ħieles kienu simili għal dawk ta ’ suġġetti f’ saħħithom.
No data are available in patients with severe hepatic impairment (Child-Pugh class C).
M’ hemmx tagħrif disponibbli dwar pazjenti b’ indeboliment epatiku qawwi (Child- Pugh Klassi C).
11 Renal Impairment Elimination of paliperidone decreased with decreasing renal function.
Indeboliment Renali L- eliminazzjoni ta ’ paliperidone naqas bit- tnaqqis tal- funzjoni renali.
Total clearance of paliperidone was reduced in subjects with impaired renal function by 32% in mild (Creatinine Clearance [Cr Cl] = 50 to < 80 ml/ min), 64% in moderate (CrCl = 30 to < 50 ml/ min), and 71% in severe (CrCl = < 30 ml/ min) renal impairment.
It- tneħħija totali ta ’ paliperidone naqset bi 32% f’ suġġetti b’ indeboliment renali ħafif (Tneħħija tal- Kreatinina [CrCl] = 50 to < 80 ml/ min), b’ 64% f’ indeboliment moderat (CrCl = 30 to < 50 ml/ min), u 71% f’ indeboliment sever (CrCl = < 30 ml/ min).
The mean terminal elimination half-life of paliperidone was 24, 40, and 51 hours in subjects with mild, moderate, and severe renal impairment, respectively, compared with 23 hours in subjects with normal renal function (CrCl ≥ 80 ml/ min).
Il- half- life medja ta ’ l- eliminazzjoni terminali ta ’ paliperidone kienet ta ’ 24, 40 u 51 siegħa għal suġġetti b’ indeboliment renali ħafif, moderat u qawwi rispettivament, meta mqabbel ma ’ 23 siegħa f’ suġġetti b’ funzjoni renali normali (CrCl ≥ 80 ml/ min).
Elderly Data from a pharmacokinetic study in elderly subjects (≥ 65 years of age, n = 26) indicated that the apparent steady-state clearance of paliperidone following INVEGA administration was 20% lower compared to that of adult subjects (18-45 years of age, n = 28).
Anzjani Tagħrif minn studju farmakokinetiku f’ suġġetti anzjani (età ≥ 65 sena, n = 26) indika li t- tneħħija fi stat fiss apparenti ta ’ paliperidone wara l- amministrazzjoni ta ’ INVEGA kien 20% iktar baxx meta mqabbel ma ’ suġġetti adulti (età bejn 18- 45 sena, n = 28).
However, there was no discernable effect of age in the population pharmacokinetic analysis involving schizophrenia subjects after correction of age-related decreases in CrCl.
Madankollu, ma deherx li kien hemm effett ta ’ età fl- analiżi farmakokinetika tal- popolazzjoni li kienet tinvolvi suġġetti bi skiżofrenja wara l - korrezzjoni tat- tnaqqis marbut ma ’ l- età fi CrCl..
Race Population pharmacokinetics analysis revealed no evidence of race-related differences in the pharmacokinetics of paliperidone following INVEGA administration.
Razza Analiżi tal- farmakokinetika tal- popolazzjoni ma uriet l- ebda evidenza ta ’ differenzi marbuta mar- razza fil- karatteristiċi farmakokinetiċi ta ’ paliperidone wara l- amministrazzjoni ta ’ INVEGA.
Gender The apparent clearance of paliperidone following INVEGA administration is approximately 19% lower in women than men.
Sess It- tneħħija apparenti ta ’ paliperidone wara l- amministrazzjoni ta ’ INVEGA kienet bejn wieħed u ieħor 19% iktar baxxa fin- nisa milli fl- irġiel.
This difference is largely explained by differences in lean body mass and creatinine clearance between men and women.
Ħafna minn din id- differenza hija dovuta għal differenzi bejn in- nisa u l- irġiel fil- massa tal- ġisem mingħajr xaħam u t- tneħħija tal- kreatinina.
Smoking Status Based on in vitro studies utilising human liver enzymes, paliperidone is not a substrate for CYP1A2; smoking should, therefore, not have an effect on the pharmacokinetics of paliperidone.
12 Fuq il- bażi ta ’ studji in vitro li użaw enżimi tal- fwied uman, paliperidone mhux sustrat għal CYP1A2; għalhekk, it- tipjip mhux suppost ikollu effett fuq il- karatteristiċi farmakokinetiċi ta ’ paliperidone.
A population pharmacokinetic analysis showed a slightly lower exposure to paliperidone in smokers compared with non-smokers.
Analiżi farmakokinetika tal- popolazzjoni uriet espożizzjoni kemmxejn inqas għal paliperidone f’ min ipejjep meta mqabbla ma ’ min ma jpejjipx.
The difference is unlikely to be of clinical relevance, though.
Madankollu d- differenza aktarx li ma jkollhiex rilevanza klinika.
Repeat-dose toxicity studies of paliperidone in rat and dog showed mainly pharmacological effects, such as sedation and prolactin-mediated effects on mammary glands and genitals.
Studji tossikoloġiċi b’ doża ripetuta ta ’ paliperidone fuq il- firien u l- klieb l- iktar li urew kienu effetti farmakoloġiċi, bħal sedazzjoni u effetti medjati mill- prolaktin fuq il- glandoli mammarji u l- ġenitali.
Paliperidone was not teratogenic in rat and rabbit.
Paliperidone ma kienx teratoġeniku fuq il- firien u l- fniek.
In rat reproduction studies using risperidone, which is extensively converted to paliperidone in rats and humans, a reduction was observed in the birth weight and survival of the offspring.
Fi studji dwar riproduzzjoni fil- firien fejn intuża risperidone, li jiġi konvertit b’ mod estensiv għal paliperdone fil- firien u l- bnedmin, ġew osservati tnaqqis fil- piż fit- twelid u s- sopravivenza tal- friegħ.
Other dopamine antagonists, when administered to pregnant animals, have caused negative effects on learning and motor development in the offspring.
Meta antagonisti oħrajn tad- dopamina ġew amministrati lil annimali ħobla, kellhom effetti negattivi fuq it- tagħlim u l- iżvilupp motorju tal - friegħ.
Paliperidone was not genotoxic in a battery of tests.
F’ serje ta ’ testijiet paliperidone ma kienx ġenotossiku.
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.
Fi studji dwar il- karċinoġeniċità orali ta ’ risperidone fil- firien u l- ġrieden, ġew osservati żidiet fl- adenomi tal- glandoli pitwitarji (fil- ġrieden), adenomi endokrinali fil- frixa (fil- firien) u adenomi tal- glandoli mammarji (fiż- żewġ speċi).
These tumours can be related to prolonged dopamine D2 antagonism and hyperprolactinemia.
Dawn it - tumuri jistgħu jintrabtu ma ’ antagoniżmu tad- dopamina D2 fit- tul u iperprolaktinemija.
The relevance of these tumour findings in rodents in terms of human risk is unknown.
Mhix magħrufa r- rilevanza għar- riskju lill- bnedmin ta ’ dawn l- osservazzjonijiet ta ’ tumuri f’ annimal gerriema.
For the 1.5 mg tablet:
Għall- pillola tal- 1. 5 mg:
Coated tablet core:
Il- qalba tal- pillola miksija:
12 Stearic acid Butyl hydroxytoluene (E321) Iron oxide (black) (E172) Polyethylene oxide 7000K Ferric oxide (red) (E172) Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Polyethylene oxide 200K Sodium chloride Povidone (K29- 32) Stearic acid Butyl hydroxytoluene E321 Iron oxide (iswed) E172 Polyethylene oxide 7000K Ferric oxide (aħmar) E172 Hydroxyethyl cellulose Polyethylene glycol 3350 Cellulose acetate
Colour overcoat:
Il- kulur tal- kisja ta ’ barra:
Hypromellose Titanium dioxide (E171) Polyethylene glycol 400 Ferric oxide (yellow) (E172) Ferric oxide (red) (E172) Carnauba wax
Hypromellose Titanium dioxide E171 Polyethylene glycol 400 Ferric oxide (isfar) E172 Ferric oxide (aħmar) E172 Carnauba wax
Printing ink:
Linka ta ’ l- istampar:
Iron oxide (black) (E172) Propylene glycol Hypromellose
Iron oxide (iswed) E172 Propylene glycol Hypromellose
Bottles:
Fliexken:
Keep the bottle tightly closed in order to protect from moisture.
Żomm il- flixkun magħluq sewwa sabiex tilqa ’ mill- umdità.
Blisters:
Folji:
White high-density polyethylene (HDPE) bottle with induction sealing and polypropylene child- resistant closure.
Flixkun abjad tal- polyethylene ta ’ densità għolja (HDPE) b’ siġill ta ’ induzzjoni u għeluq ta ’ polypropylene reżistenti għat- tfal.
Each bottle contains two 1 g dessicant silica gel (silicone dioxide) pouches (pouch is food approved polyethylene).
Kull flixkun fih żewġ boroż (borża magħmula minn polyethylene approvat għall- ikel) ta ’ 1g ta ’ silica gel li jnixxef (silicone dioxide).
Pack sizes of 30 and 350 prolonged-release tablets.
Daqsijiet ta ’ pakketti ta ’ 30 u 350 pillola li jerħu l- mediċina bil- mod.
• Polyvinyl chloride (PVC) laminated with polychloro-trifluoroethylene (PCTFE)/ aluminium push- through layer.
• Polyvinyl chloride (PVC) laminat b’ saff ta ’ polychloro- trifluoroethylene (PCTFE) / aluminju li timbotta b’ subgħajk.
Pack sizes of 14, 28, 30, 49, 56, and 98 prolonged-release tablets.
Daqsijiet ta ’ pakketti ta ’ 14, 28, 30, 49, 56, u 98 pillola li jerħu l- mediċina bil- mod.
• White polyvinyl chloride (PVC) laminated with polychloro-trifluoroethylene (PCTFE)/ aluminium push- through layer.
• Polyvinyl chloride abjad (PVC) laminat b’ polychloro- trifluoroethylene (PCTFE) / aluminju saff li timbotta b’ subgħajk.
13 Or
Jew
• Oriented polyamide (OPA)-aluminium-polyvinyl chloride (PVC)/ aluminium push-through layer.
• Oriented polyamide (OPA) - aluminium- polyvinyl chloride (PVC) / aluminju li timbotta b’ subgħajk.
Pack sizes of 14, 28, 49, 56, and 98 prolonged-release tablets.
Daqsijiet ta ’ pakketti ta ’ 14, 28, 30, 49, 56, u 98 pillola li jerħu l- mediċina bil- mod.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu jistgħu jitqiegħdu fuq is- suq.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.
Janssen- Cilag International NV, Turnhoutseweg 30, B- 2340 Beerse, Il- Belġju.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA): http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- mediċini (EMEA) http: // www. emea. europa. eu /.
INVEGA 3 mg prolonged-release tablets
INVEGA pilloli tat- 3 mg li jerħu l- mediċina bil- mod
Each prolonged-release tablet contains 3 mg of paliperidone.
Kull pillola li terħi l- mediċina bil- mod fiha 3 mg ta ’ paliperidone.
Excipient:
GĦAL PILLOLI TA ’ 3 MG:
Each tablet contains 13.2 mg lactose.
Sustanza mhux attiva: kull pillola fiha 13. 2 mg ta ’ lactose.
Trilayer capsule-shaped white tablets printed with “ PAL 3”
Pilloli b’ forma ta ’ kapsula bojod bi tliet saffi stampati b ’ “ PAL 3 ”
Adults INVEGA is for oral administration.
INVEGA tittieħed mill- ħalq.
When dose increases are indicated, increments of 3 mg/ day are recommended and generally should occur at intervals of more than 5 days.
Meta jiġu indikati żidiet fid - dożi, huma rrakkomandati żidiet ta ’ 3mg/ kuljum u ġeneralment dawn għandhom iseħħu b’ intervalli ta ’ iktar minn 5 ijiem.
INVEGA must be swallowed whole with liquid, and must not be chewed, divided, or crushed.
INVEGA għandu jinbela ’ sħiħ ma’ likwidu, u m’ għandux jiġi magħmud, maqsum jew imfarrak.
The active substance is contained within a non absorbable shell designed to release the active substance at a controlled rate.
Is - sustanza attiva tinsab f’ qoxra li l- ġisem ma jassorbix, u li hi maħduma biex is- sustanza tintreħa b’ mod kontrollat.
The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.
Il- qoxra tal- pillola, flimkien mal- komponenti tal- qalba li ma jdubux, jiġu eliminati mill - ġisem; il- pazjenti m’ għandhomx jinkwetaw jekk xi kultant jaraw xi ħaġa qisha pillola fl- ippurgar.
Patients with hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment.
Pazjenti b’ indeboliment epatiku
As INVEGA has not been studied in patients with severe hepatic impairment, caution is recommended in such patients.
Pazjenti b’ indeboliment renali
Patients with renal impairment For patients with mild renal impairment (creatinine clearance ≥ 50 to < 80 ml/ min), the recommended initial dose is 3 mg once daily.
16 Għal pazjenti b’ indeboliment renali ħafif (tneħħija tal- kreatinina ≥ 50 sa < 80 ml/ min), id- doża inizzjali rakkomandata hi ta ’ 3 mg darba kuljum.
The dose may be increased to 6 mg once daily based on clinical response and tolerability.
Id- doża tista ’ tiżdied għal 6 mg darba kuljum skond ir- respons u t- tollerabilità klinika.
For patients with moderate to severe renal impairment (creatinine clearance ≥ 10 to < 50 ml/ min), the recommended initial dose of INVEGA is 1.5 mg every day, which may be increased to 3 mg once daily
Għal pazjenti b’ indeboliment renali moderat għal qawwi (tneħħija tal- kreatinina ≥ 10 sa < 50 ml/ min), id- doża inizzjali rakkomandata ta ’ INVEGA hija 1. 5 mg jum kuljum, li tista ’ tiżdied għal 3 mg kuljum wara evalwazzjoni klinika mill- ġdid.
As INVEGA has not been studied in patients with creatinine clearance below 10 ml/ min, use is not recommended in such patients.
Billi INVEGA ma ġiex studjat f’ pazjenti bi tneħħija tal - kreatinina taħt l- 10 ml/ min, l- amministrazzjoni f’ dawn il- pazjenti mhux rakkomandata.
Elderly Dosing recommendations for elderly patients with normal renal function (≥ 80 ml/ min) are the same as for adults with normal renal function.
Anzjani Ir- rakkomandazzjoni għad- dożaġġ għal pazjenti anzjani li għandhom funzjoni renali normali (≥ 80 ml/ min) hija l- istess għall- adulti b’ funzjoni renali normali.
INVEGA should be used with caution in elderly patients with dementia with risk factors for stroke (see section 4.4).
INVEGA għandu jintuża b’ kawtela f’ pazjenti anzjani b’ dimenzja b’ riskju ta ’ aċċessjoni (ara sezzjoni 4. 4).
Other special populations No dose adjustment for INVEGA is recommended based on gender, race, or smoking status.
Popolazzjonijiet oħra Mhux rakkomandat bidla fid- doża ta ’ INVEGA skond is- sess, razza jew jekk il- pazjent ipejjipx jew le.
(For pregnant women and breast-feeding mothers, see section 4.6)
(Għal nisa tqal u li qed ireddgħu, ara sezzjoni 4. 6)
Due to different pharmacodynamic and pharmacokinetic profiles among antipsychotic medicinal products, supervision by a clinician is needed when switching to another antipsychotic product is considered medically appropriate.
Minħabba l- profili differenti farmakodinamiċi u farmakokinetiċi fost il- prodotti mediċinali antipsikotiċi, hija meħtieġa s- superviżjoni ta ’ tabib meta l- qlib għal prodott antipsikotiku ieħor jitqies xieraq mill- aspett mediku.
QT interval As with other antipsychotics, caution should be exercised when INVEGA is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicines thought to prolong the QT interval.
INVEGA għandu jingħata wkoll b’ kawtela flimkien ma ’ mediċini oħra li huwa maħsub li jtawlu l- intervall QT.