FrancophonIA/ELRC3.0 huggingface dataset:
English: Shake the vial vigorously for at least 10 seconds until obtaining a homogeneous suspension.
Maltese: Ħawwad il-kunjett bis-saħħa għal mill-anqas 10 sekondi sakemm ikollok suspensjoni omoġena.
English: Johnson & Johnson s.r.o.
Maltese: Is-Slovakkja Johnson & Johnson s.r.o. Plynárenská 7/B
English: The onset of extrapyramidal symptoms is a risk factor for tardive dyskinesia.
Maltese: Il-bidu ta' sintomi ekstrapiramidali huwa fattur ta' riskju għal diskajniżja tardiva.
English: Erythromycin, a CYP 3A4 inhibitor, does not change the pharmacokinetics of risperidone and the active antipsychotic fraction.
Maltese: Erythromycin, impeditur ta' CYP 3A4 ma jibdilx il-farmakokinetika ta' risperidone u l-porzjon antipsikotiku attiv.
English: Adverse Drug Reactions by System Organ Class and Frequency Category Investigations
Maltese: Reazzjonijiet Avversi skond is-Sistema tal-Klassifikazzjoni ta' l-Organi u l-Frekwenza Investigazzjonijiet
English: Estonia:
Maltese: L-Estonja:
English: 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.
Maltese: 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.
English: For section 4.3, the CHMP discussed the relevance of a Contraindication warning for patients with high risk factors for cerebrovasular adverse events.
Maltese: Fis-sezzjoni 4.3, is-CHMP iddiskuta r-relevanza ta' twissija ta' Kontraindikazzjoni għall-pazjenti b'fatturi ta' riskju għoljin għal episodji ċerebrovaskulari avversi.
English: Furthermore, the PK of Risperdal Consta in the elderly population was adequately described, and it was shown that the pharmacokinetics in the population > 65 years are comparable to the population < 65 years.
Maltese: Barra minn hekk, il-PK ta' Risperdal Consta fil-popolazzjoni anzjana kien deskritt adegwatement, u intwera li l-farmakokinetiċi fil-popolazzjoni > 65 sena huma komparabbli mal-popolazzjoni < 65 sena.
English: The pooled data from six placebo-controlled studies in mainly elderly patients (>65 years of age) with dementia showed that CVAEs (serious and nonserious, combined) occurred in 3.3% (33/1009) of patients treated with risperidone and 1.2% (8/712) of patients treated with placebo.
Maltese: Id-dejta pooled minn sitt studji kkontrollati bi plaċebo f'pazjenti li l-maggoranza tagħhom kienu anzjani (età > 65 sena) bid-dimenzja urew li CVAEs (serji u mhux serji, flimkien) seħħew f'3.3% (33/1009) tal-pazjenti kkurati b'risperidone u f'1.2% (8/712) talpazjenti kkurati bi plaċebo.
English: • Two Hypoint 20G 2” TW needles for reconstitution
Maltese: • Żewġ labriet Hypoint 20G 2" TW għar-rikostituzzjoni
English: • Medicines for Parkinson's disease (such as levodopa)
Maltese: • Mediċini għall-marda ta' Parkinson (bħal levodopa)
English: Janssen Cilag International NV Turnhoutseweg 30, 2340 Beerse, Belgium
Maltese: Janssen Cilag International NV Turnhoutseweg 30, 2340
English: WHAT RISPERDAL CONSTA IS AND WHAT IT IS USED FOR RISPERDAL CONSTA belongs to a group of medicines called ‘anti-psychotics'.
Maltese: RISPERDAL CONSTA tagħmel parti minn grupp ta' mediċini imsejħa ‘anti-psikotiċi'.
English: Contents of the dose pack:
Maltese: Kontenut tal-pakkett tad-doża:
English: Metabolism and Nutrition Disorders
Maltese: Disturbi fil-Metaboliżmu u n-Nutrizzjoni
English: Over time efficacy was maintained with RISPERDAL CONSTA (Figure 1).
Maltese: Matul iż-żmien l-effikaċja b' RISPERDAL CONSTA inżammet (Figura 1).
English: Similar effects may be observed with e.g. rifampicin, phenytoin and phenobarbital which also induce CYP 3A4 hepatic enzyme as well as P-glycoprotein.
Maltese: Effetti jixxiebhu jistgħu jiġu osservati eż. b'rifampicin, phenytoin u phenobarbital li wkoll jinduċu l-enzima epatika CYP 3A4 kif ukoll il-glikoproteina-P.
English: • Nasal congestion
Maltese: • Kongestjoni nażali
English: Batch
Maltese: Bażi
English: Potential for RISPERDAL CONSTA to affect other medicinal products
Maltese: Il-potenzjal ta' RISPERDAL CONSTA li jaffettwa prodotti mediċinali oħra
English: Neuroleptic Malignant Syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels has been reported to occur with antipsychotics.
Maltese: Is-Sindrome Newrolettiku Malinn, ikkaratterizzat minn ipertermja, ebusija fil-muskoli, instabbilità awtonomika, livell mibdul ta' koxjenza u livelli ta' creatine phosphokinase li jogħlew ġew irrappurtati li jseħħu b'antipsikotiċi.
English: Pharmacotherapeutic group: Other antipsychotics, ATC code: N05AX08
Maltese: Antipsikotiċi oħra, Kodiċi ATC:
English: RISPERDAL® CONSTA® Czech Republic: RISPERDAL® CONSTA® Denmark: RISPERDAL® CONSTA®
Maltese: Iċċekkja mat-tabib jew l-ispiżjar tiegħek qabel tuża RISPERDAL CONSTA jekk:
English: 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.
Maltese: 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).
English: Extensive CYP 2D6 metabolisers convert risperidone rapidly into 9-hydroxy-risperidone, whereas poor CYP 2D6 metabolisers convert it much more slowly.
Maltese: Metabolizzaturi estensivi ta' CYP 2D6 jibdlu risperidone malajr f'9-hydroxy-risperidone, filwaqt li metabolizzaturi nieqsa jibdluh ħafna aktar bil-mod.
English: These tumours observed upon oral and intramuscular dosing can be related to prolonged dopamine D2 antagonism and hyperprolactinaemia.
Maltese: Dawn it-tumuri osservati wara ddożar orali u ġol-muskolu jistgħu jkunu relatati ma' antagoniżmu fit-tul tad-dopamine D2 u iperprolaktinimja.
English: In case of severe extrapyramidal symptoms, anticholinergic medicinal product should be administered.
Maltese: F'każ ta' sintomi ekstrapiramidali qawwija, għanda tingħata prodott mediċinali antikolinerġika.
English: Prolonged-release microcapsule and solvent for suspension for injection
Maltese: Mikrokapsula li terħi bil-mod il- mediċina u solvent għal suspenzjoni għall injezzjoni
English: The efficacy of the 12.5 mg dose has not been investigated in clinical trials.
Maltese: L-effikaċja tad-doża ta' 12.5mg ma ġietx investigata fi provi kliniċi.
English: 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.
Maltese: 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.
English: RISPERDAL® CONSTA Hungary: RISPERDAL CONSTA Iceland:
Maltese: Tieħux RISPERDAL CONSTA:
English: Fluoxetine and paroxetine, CYP 2D6 inhibitors, increase the plasma concentration of risperidone, but less so of the active antipsychotic fraction.
Maltese: Fluoxetine u paroxetine, impedituri ta' CYP 2D6, iżidu l-konċentrazzjoni ta' risperidone fil-plażma, iżda mhux daqstant il-porzjon antipsikotiku attiv.
English: See section 4.4 regarding increased mortality in elderly patients with dementia concomitantly receiving furosemide.
Maltese: Ara sezzjoni 4.4 dwar mortalità ogħla f'pazjenti anzjani bid-dimenzja li qed jirċievu wkoll furosemide.
English: Sexual dysfunction, Gynaecomastia
Maltese: Disfunzjoni sesswali, Ġinekomastja
English: Latvia:
Maltese: Il-Latvja:
English: Risperidone plus 9-hydroxy-risperidone form the active antipsychotic fraction.
Maltese: Risperidone flimkien ma' 9-hydroxy risperidone jiffurmaw il-porzjon antipsikotiku attiv.
English: • Gait disturbance, edema, body temperature increased, drug allergy, speech disorder, movement disorder
Maltese: • Disturb fil-mixi, edima, żieda fit-temperatura tal-ġisem, allerġija għall-mediċini, disturb fit taħdid, disturb fil-moviment
English: 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.
Maltese: Effetti oħra tal-qalb li huma relatati mal-klassi rrappurtati b'antipsikotiċi li jtawwlu lintervall QT jinkludu arritmija tal-ventrikulu, fibrillazzjoni tal-ventirikulu, takikardija tal-ventrikulu, mewt zoptu, waqfien tal-qalb u Torsades de Pointes.
English: In placebo-controlled trials in elderly patients with dementia there was a significantly higher incidence (approximately 3-fold increased) of CVAEs, such as stroke (including fatalities) and transient ischaemic attack in patients treated with RISPERDAL compared with patients treated with placebo (mean age 85 years; range 73 to 97).
Maltese: Fi provi kkontrollati bi plaċebo f'pazjenti anzjani bid-dimenzja kien hemm inċidenza sinifikament ogħla (bejn wieħed u ieħor 3-darbiet aktar) ta' CVAEs, bħal puplesija (inkluż imwiet) u attakk iskemiku għaddieni f'pazjenti kkurati b'RISPERDAL meta mqabbla ma' pazjenti kkurati bi plaċebo (età medja 85 sena; medda 73 sa 97).
English: For section 4.6, the CHMP discussed the wording, moving the mention of galactorrhea to section 4.8 and adopting the following harmonised wording:
Maltese: Għal sezzjoni 4.6, is-CHMP iddiskuta l-formolazzjoni tal-kliem u ressaq l-aċċenn għal galaktorreja għal sezzjoni 4.8 u adotta l-kitba armonizzata li ġejja:
English: High-Wycombe Buckinghamshire HP 14 4HJ United Kingdom
Maltese: Buckinghamshire HP 14 4HJ Ir-Renju Unit
English: Granulocytopenia
Maltese: РИСПОЛЕПТ
English: 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.
Maltese: 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.
English: Hepatic and renal impairment RISPERDAL CONSTA has not been studied in hepatically and renally impaired patients.
Maltese: Indeboliment epatiku u renali RISPERDAL CONSTA ma ġiex studjat f'pazjenti b'indebolimet epatiku jew renali.
English: 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.
Maltese: 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.
English: Galantamine and donepezil do not show a clinically relevant effect on the pharmacokinetics of risperidone and on the active antipsychotic fraction.
Maltese: Galantamine u donepezil ma jurux effett kilinikament relevanti fuq il-farmakokinetika ta' risperidone u fuq il- porzjon antipsikotiku attiv.
English: The most frequently reported adverse drug reactions (ADRs) (incidence ≥ 1/10) are: Insomnia, anxiety, headache, upper respiratory tract infection, parkinsonism, depression, and akathisia.
Maltese: 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.
English: Poland:
Maltese: Il-Polonja:
English: The pharmacokinetics of risperidone are also linear in the dose range of 25-50 mg injected every 2 weeks.
Maltese: Il-farmakokinetika ta' risperidone hija lineari wkoll fil-medda tad-doża ta' 25-50 mg injettat kull ġimgħatejn.
English: STATEMENT OF ACTIVE SUBSTANCE(S) [To be completed nationally]
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: For a full list of excipients, see section 6.1.
Maltese: U KWANTITATTIVA [Biex timtela mill-pajjiż partikolari.] Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: Inappropriate antidiuretic hormone secretion Metabolism and nutrition disorders Uncommon
Maltese: Tnixxija mhux adattata ta' ormon antidijuretiku Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux Komuni
English: Phenothiazines, tricyclic antidepressants, and some beta-blockers may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction.
Maltese: Phenothiazines, antidipressanti triċikliċi, u xi blokkaturi tar-riċetturi beta jistgħu jżidu lkonċentrazzjonijiet ta' risperidone fil-plażma iżda mhux dawk tal-porzjoni antipsikotiku attiv.
English: b Extrapyramidal disorder may occur: 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.
Maltese: Manija, Tnaqqis fil-libido, Nervożiżmu aIperprolaktinimja tista' f'xi każijiet twassal għal ġinekomastja, disturbi menstruwali, amenorreja, galaktorreja. bJista' jseħħ disturb ekstrapiramidali: Parkinsoniżmu (ipersekrezzjoni ta' bżiq, ebusija muskoluskeletrali, 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 filmuskoli, mixi parkinsonjan, u rifless glabellari mhux normali ), Akatiżja (akatiżja, nuqqas ta' kwiet, iperkajneżja u sindrome ta' saqajn bla kwiet), rogħda, diskajneżja (diskajneżja, kontrazzjoni talmuskoli għall-għarrieda, koreoatetożi, atetożi, u mijoklonus), distonija.
English: Medicines with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical involuntary movements, predominantly of the tongue and/or face.
Maltese: Mediċini li għandhom kwalitajiet antagonistiċi għar-riċetturi dopamine ġew assoċjati ma' l-induzzjoni ta' diskajniżja tardiva ikkaratterizzata minn movimenti ritmiċi involuntarji, l-aktar predominanti flilsien u/jew il-wiċċ.
English: • fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome).
Maltese: • deni, ebusija qawwija fil-muskoli, għaraq jew livell imnaqqas ta' koxjenza (disturb imsejjaħ “sindrome newrolettiku malinn”).
English: • Inability to sleep, anxiety, depression, irritability, feeling of inner restlessness
Maltese: • Ma tkunx tista' torqod, ansjetà, depressjoni, irritabilità, tħoss nuqqas ta' kwiet minn ġewwa
English: Excipients
Maltese: IPPREŻENTATI
English: • Phenothiazines (e.g. used to treat psychosis or to calm down)
Maltese: • Phenothiazines (eż. użati biex jikkuraw psikożi jew biex tikkalma)
English: Jaundice Reproductive system and breast disorders Common
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Mhux komuni
English: Cystitis, Gastroenteritis, Infection, Localised infection, Subcutaneous abscess
Maltese: Ċistite, Gastroenterite, Infezzjoni, Infezzjoni lokalizzata, Axxess taħt il-ġilda Korriment u avvalenament
English: Body temperature regulation
Maltese: Regulazzjoni tat-Temperatura tal-Ġisem
English: “Risperdal Consta is indicated for the maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics”.
Maltese: “Risperdal Consta huwa indikat għall-kura ta' manteniment ta' skizofrenija f'pazjenti li bħalissa huma stabbilizzati b'antipsikotiċi orali”.
English: Convulsion, Syncope, Dizziness postural, Hypoaesthesia, Paraesthesia, Lethargy, Hypersomnia
Maltese: Aċċessjonijiet, Sinkope, Sturdament mal-waqfien, Ipoesteżija, Parestesija, Letarġija, Ipersomnja
English: • Inflammation of the pancreas.
Maltese: • Ara tabib immedjatament.
English: Plynárenská 7/B Bratislava
Maltese: INFORMAZZJONI BIL-BRAILLE
English: For section 4.2, the CHMP discussed the Risperdal Consta starting dose (25 mg, intramuscular, every 2 weeks), considering the data provided by the MAH, and was of the opinion that the recommendation in the SPC that treatment should be started with the dose of 25 mg every two weeks should be maintained.
Maltese: Għal sezzjoni 4.2, is-CHMP iddiskuta d-doża tal-bidu ta' Risperdal Consta (25 mg, intramuskolari, kull ġimagħtejn), wara li kkunsidra t-tagħrif ipprovdut mill-MAH, u kien ta' l-opinjoni li rrakkomandazzjoni fl-SPC li l-kura għandha tinbeda b'doża ta' 25 mg kull ġimagħtejn għandha tinżamm.
English: Belgium Janssen Cilag N.V. Roderveldlaan 1, 2600 Berchem, Belgium
Maltese: Roderveldlaan 1, 2600
English: Orthostatic hypotension
Maltese: Pressjoni Baxxa Ortostatika
English: 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%.
Maltese: 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%.
English: Parkinson's disease and dementia with Lewy bodies
Maltese: Marda ta' Parkinson u Dimenzja bil-Korpi Lewy
English: Therapeutic plasma concentrations remain until 4 to 6 weeks after the last RISPERDAL CONSTA injection.
Maltese: Konċentrazzjonijiet terapewtiċi filplażma jibqgħu bejn 4 u 6 ġimgħat wara li tingħata l-aħħar injezzjoni ta' RISPERDAL CONSTA.
English: Potential for other medicinal products to affect RISPERDAL CONSTA
Maltese: Il-potenzjal ta' prodotti mediċinali oħra li jaffettwaw RISPERDAL CONSTA
English: Take special care with RISPERDAL CONSTA
Maltese: QABEL MA TUŻA RISPERDAL CONSTA
English: Respiratory, Thoracic, and Mediastinal Disorders Wheezing, Pneumonia aspiration, Pulmonary congestion, Respiratory disorder, Rales, Epistaxis, Respiratory tract congestion, Hyperventilation, Dysphonia Gastrointestinal Disorders
Maltese: Disturbi Respiratorji, Toraċiċi u Medjastinali Tħarħir, Pulmonite minħabba aspirazzjoni, Konġestjoni tal-pulmuni, Disturb respiratorju, Ħsejjes tal-pulmun, Epistażi, Konġestjoni ta' l-apparat tan-nifs, Iperventilazzjoni, Disfonja Disturbi Gastro-intestinali
English: Janssen-Cilag Ltd.
Maltese: Ir-Renju Unit Janssen-Cilag Ltd.
English: Arthralgia, Back pain, Pain in extremity, Myalgia
Maltese: Artralġja, Uġigħ fid-dahar, Uġigħ fl-idejn u fis-saqajn, Majalġja
English: The CHMP further assessed data from patients switched to Risperdal Consta without stabilisation on oral risperidone, and concluded that sufficient antipsychotic coverage should be ensured during a lag period following the first Risperdal Consta injection.
Maltese: Is-CHMP kompla jivvaluta iktar tagħrif minn pazjenti li nqelbu għal fuq Risperdal Consta mingħajr stabilizzazzjoni fuq risperidone orali, u kkonkluda li għandha tkun assigurata kopertura antipsikotika suffiċjenti waqt perijodu ta' differenza wara l-ewwel injezzjoni ta' Risperdal Consta.
English: Gender, race and smoking habits
Maltese: Sess, razza u tipjip
English: Hoffsveien 1D 0275 Oslo Norway powder (microspheres) and a solvent for suspension for injection
Maltese: Hoffsveien 1D 0275 Oslo In-Norveġja
English: Hyperglycemia
Maltese: Il-Belġju
English: Unresponsive to stimuli, Loss of consciousness, Neuroleptic malignant syndrome, Diabetic coma, Cerebrovascular accident, Depressed level of consciousness, Cerebral ischemia, Cerebrovascular disorder, Transient ischemic attack, Dysarthria, Disturbance in attention, Balance disorder, Speech disorder, Coordination abnormal, Movement disorder Eye Disorders
Maltese: Mingħajr rispons għal stimuli, Telf ta' koxjenza, Sindrome Newrolettikku Malinn, Koma dijabetika, Aċċident ċerebrovaskulari, Livell ta' koxjenza depressat, Iskemija ċerebrali, Disturb ċerebrovaskulari, Attakk iskemiku għaddieni, Disartrija, Disturb fl-attenzjoni, Disturb fil-bilanċ, Disturb fit-taħdit, Koordinazzjoni mhux normali, Disturb fil-moviment Disturbi fl-Għajnejn
English: 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.
Maltese: 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.
English: • Lack of emotion, confusion, poor attention, loss of consciousness, balance disorder
Maltese: • Nuqqas ta' emozzjoni, konfużjoni, nuqqas t'attenzjoni, telf mis-sensi, disturb fil-bilanċ
English: Concomitant use with furosemide
Maltese: Użu Flimkien ma' Furosemide
English: Powder for suspension for injection
Maltese: Trab u soluzzjoni għal suspenzjoni u injezzjoni
English: Renal tubular adenomas occurred in male rats treated with RISPERDAL CONSTA at 40 mg/kg/2 weeks.
Maltese: Adenomi renali tubulari seħħew f'firien irġiel ikkurati b'RISPERDAL CONSTA f'doża ta' 40 mg/kg/ġimgħatejn.
English: 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.
Maltese: 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
English: • Decreased appetite, increased appetite
Maltese: • Tnaqqis fl-apptit, żieda fl-aptit
English: Renal or hepatic impairment
Maltese: Indeboliment Renali u Epatiku
English: Furthermore, « Anxiety » and « nervousness » should be separated and not grouped by the term “anxiety”.
Maltese: Barra minn hekk, « Ansjetà » u « nervożiżmu » għandhom ikunu separati u mhux raggruppati bit-terminu “ansjetà”.
English: It has a high affinity for serotoninergic 5-HT2 and dopaminergic D2 receptors.
Maltese: Għandu affinità kbira għarriċetturi serotonerġiċi 5-HT2 u dopaminerġiċi D2.
English: It is expected that other CYP 2D6 inhibitors, such as quinidine, may affect the plasma concentrations of risperidone in a similar way.
Maltese: Huwa mistenni li impedituri oħra ta' CYP 2D6, bħal quinidine, jista' jaffettwa l-konċentrazzjonijiet ta' risperidone fil-plażma b'mod jixxiebah.
English: Grasp sheath using the plastic peel pouch.
Maltese: Aqla l-għatu tal-plastik ikkulurit mill-kunjett.
English: Prolonged-release
Maltese: TAL-PRODOTT
English: RISPERDAL CONSTA may antagonise the effect of levodopa and other dopamine agonists.
Maltese: RISPERDAL CONSTA jista' jantagonizza l-effett ta' levodopa u agonisti tad-dopamine oħrajn.
English: RISPERDAL CONSTA and associated names (see Annex I) 12.5, 25, 37.5 and 50 mg powder and solvent for prolonged-release suspension for intramuscular injection [See Annex I - To be completed nationally] Risperidone
Maltese: RISPERDAL CONSTA 12.5,25, 37.5 u 50 mg trab u solvent li jerħu il-mediċina bil-mod għal suspenzjoni għall-injezzjoni ġol-muskolu [Ara Anness I - Biex timtela mill-pajjiż partikolari] Risperidone
English: Cimetidine and ranitidine increase the bioavailability of risperidone, but only marginally that of the active antipsychotic fraction.
Maltese: Cimetidine u ranitidine jżidu l-biodisponibbiltà ta' risperidone, iżda jżidu biss bi ftit dik tal-porzjon antipsikotiku attiv.