FrancophonIA/ELRC3.0 huggingface dataset:
English: • Medicines that may change the electrical activity of your heart, such as medicines for malaria, heart rhythm problems (such as quinidine), allergies (anti-histamines), some antidepressants or other medicines for mental problems
Maltese: tal-problemi fir-ritmu tal-qalb (bħal quinidine), ta' l-allerġiji (anti-istaminiċi) xi antidepressanti u mediċini oħra għall-problemi mentali
English: Powder and solvent for prolonged-release suspension for injection.
Maltese: 2 ml solvent għal suspensjoni għal injezzjoni ġol-muskolu.
English: 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.
Maltese: 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.
English: • You have kidney problems
Maltese: • Inti għandek problemi fil-kliewi
English: 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.
Maltese: 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.
English: The elimination phase is complete approximately 7 to 8 weeks after the last RISPERDAL CONSTA injection.
Maltese: Il-fażi ta' eliminazzjoni tkun kompluta bejn wieħed u ieħor minn 7 sa 8 ġimgħat wara l-aħħar injezzjoni ta' RISPERDAL CONSTA.
English: Common side effects (affects 1 to 10 users in 100):
Maltese: Effetti sekondarji komuni (jaffettwaw minn 1 sa 10 persuna li tużah minn kull 100):
English: Rare side effects (affects 1 to 10 users in 10,000):
Maltese: Effetti sekondarji rari (jaffettwaw minn 1 sa 10 persuna li tużah minn kull 10,000):
English: • People who have been given more RISPERDAL CONSTA than they should have experienced the following symptoms: sleepiness, tiredness, abnormal body movements, problems with standing and walking, dizziness from low blood pressure, and abnormal heart beats.
Maltese: • Persuni li ngħataw RISPERDAL CONSTA aktar milli suppost ħassew is-sintomi li ġejjin: ngħas, għejja, temperatura tal-ġisem mhix normali, movimenti fil-ġisem mhux normali, problemi biex joqogħodu bilwieqfa u jimxu, sturdament minħabba pressjoni baxxa u qalb ma tħabbatx b'mod normali.
English: injection containing 12.5, 25, 37.5, or 50 mg risperidone.
Maltese: Ilformulazzjoni awtorizzata ta' Risperdal Consta hija formulazzjoni ta' rilaxx fit-tul għall-injezzjoni intramuskolari (i.m.) li fiha 12.5, 25, 37.5, jew 50 mg risperidone.
English: Ear pain Respiratory, thoracic and mediastinal disorders Common
Maltese: Disturbi respiratorji, toraċiċi, u medjastinali Komuni
English: The risk/benefit of further treatment with RISPERDAL CONSTA should be assessed if clinically relevant orthostatic hypotension persists.
Maltese: Ir-riskju/benefiċċjuli titkompla kura b' RISPERDAL CONSTA għandu jiġi vvalutat jekk pressjoni baxxa mal-waqfien li tkun klinikament sinifikanti tippersisti.
English: One week after oral risperidone administration, 70% of the dose is excreted in the urine and 14% in the faeces.
Maltese: Ġimgħa wara l-għoti ta' rispridone millħalq 70% tad-doża titneħħa fl-awrina u 14% ma' l-ippurgar.
English: Mean in total PANSS score over time (LOCF) in patients with schizophrenia.
Maltese: Medja totali tal-punteġġ PANSS immarkata skond iż-żmien (LOCF) f'pazjenti bi skizofrenja.
English: The Referral procedure under Article 30 of Directive 2001/83/EC, as amended for Risperdal Consta was initiated in order to resolve divergences amongst the nationally authorised Product Information texts across the EU and EEA Member States, in particular with respect to indications, special warnings and precautions for use and interaction with other medicinal products and other forms of interaction.
Maltese: Il-proċedura ta' Riferenza skond l-Artikolu 30 tad-Direttiva 2001/83/KE, kif emendata għal Risperdal Consta inbdiet sabiex tirrisolvi diverġenzi fost it-testi tal-Fuljett ta' Tagħrif awtorizzati fuq livell nazzjonali madwar l-UE u fl-Istati Membri taż-ŻEE, b'mod partikolari fir-rigward ta' indikazzjonijiet, twissijiet speċjali u prekawżjonijiet għall-użu u interazzjoni ma' prodotti mediċinali oħrajn u forom oħra ta' interazzjoni.
English: • Eosinophil (special white blood cells ) count increased, blood creatine phosphokinase increased
Maltese: • Żieda fl-għadd ta' eosinofils (ċelluli bojod speċjali), żieda fil-creatine phosphokinase fid-demm
English: Reproductive System and Breast Disorders Ejaculation disorder, Vaginal discharge, Menstrual disorder General Disorders and Administration Site Conditions Generalised oedema, Face oedema, Gait disturbance, Thirst, Chills, Peripheral coldness, Drug withdrawal syndrome
Maltese: Disturbi fis-Sistema Riproduttiva u fis-Sider Disturb fl-ejakulazzjoni, Tnixxija mill-vaġina, Disturb fil-menstrwazzjoni Disturbi Ġenerali ta' Kif u Mnejn Jingħata Edima mifruxa, Edima fil-wiċċ, Disturb fil-mixi, Għatx, Tkexkix ta' bard, Kesħa periferali, Sindrome ta' twaqqif tal-mediċina,
English: For risperidone-naive patients, it is recommended to establish tolerability with oral risperidone prior to initiating treatment with RISPERDAL CONSTA (see section 4.2).
Maltese: F'pazjenti inġenwi għal risperidone, huwa rakkomandat li tiġi stabbilita tolleranza b'risperidone millħalq qabel ma' tinbeda kura b'RISPERDAL CONSTA (ara sezzjoni 4.2).
English: Elderly patients with dementia treated with atypical antipsychotics have an increased mortality compared to placebo in a meta-analysis of 17 controlled trials of atypical antipsychotics, including oral RISPERDAL.
Maltese: Pazjenti anzjani bid-dimenzja kkurati b'antipsikotiċi atipiċi għandhom żieda fil-mortalità meta mqabbla ma' plaċebo f'meta-analiżi ta' 17-il prova kkontrollata ta' antipsikotiċi atipiċi li jinkludu RISPERDAL mill-ħalq.
English: 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.
Maltese: Studji magħmula biex jesploraw differenzi filprofil 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 filprolactin tas-serum, u tibdiliet renali bħala rispons għal risperidone.
English: QT prolongation
Maltese: Uġigħ waqt proċedura
English: Confusional state, Listless, Anorgasmia, Blunted affect Nervous System Disorders
Maltese: Stat Konfużjonali, Nuqqas ta' interess, Anorgażmija, Effett ta' nuqqas ta' sensittività Disturbi fis-Sistema Nervuża
English: 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.
Maltese: 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.
English: Solvent for RISPERDAL CONSTA 12.5 mg/25 mg/37.5 mg/50 mg and associated names (see Annex I) [See Annex I - To be completed nationally]
Maltese: U MNEJN GĦANDU JINGĦATA Solvent għal RISPERDAL CONSTA 12.5 mg/25 mg/37.5 mg/50 mg u ismijiet assoċjati miegħu (ara Anness I)
English: RISPERDAL CONSTA and associated names (see Annex I) 37.5 mg powder and solvent for prolonged-release suspension for intramuscular injection
Maltese: RISPERDAL CONSTA u ismijiet assoċjati miegħu (ara Anness I) 37.5 mg trab u solvent għal suspensjoni li jerħi l-mediċina bil-mod għall-injezzjoni ġol-muskolu
English: RISPERDAL® CONSTA Sweden: RISPERDAL® CONSTA® United Kingdom: RISPERDAL® CONSTA®
Maltese: • It-tabib tiegħek jista' jiktiblek RISPERDAL li jittieħed mill-ħalq għall-l-ewwel tliet ġimgħat wara l-ewwel injezzjoni tiegħek.
English: Invented Name Strength
Maltese: Folja forma ta' borża
English: 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.
Maltese: 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.
English: • One Needle-Pro needle for intramuscular injection (safety 20G 2” TW needle-with needle protection device)
Maltese: • Labra waħda Needle-Pro għall-injezzjoni ġol-muskolu (labra ta' sigurtà 20G 2" TW b'apparat ta' protezzjoni għal-labra)
English: In placebo-controlled trials with oral RISPERDAL in this population, the incidence of mortality was 4.0% for RISPERDAL-treated patients compared to 3.1% for placebotreated patients.
Maltese: Fi provi kliniċi kkontrollati bi plaċebo b'RISPERDAL mill-ħalq f'din ilpopolazzjoni, l-inċidenza ta' mortalità kienet ta' 4.0% għall-pazjenti kkurati b'RISPERDAL meta mqabbla ma' 3.1% għall-pazjenti kkurati bil-plaċebo.
English: Risperidone plasma concentrations were normal in patients with liver insufficiency, but the mean free fraction of risperidone in plasma was increased by about 35%.
Maltese: 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%.
English: Electrocardiogram QT prolonged
Maltese: Sensittività eċċessiva għall-mediċina
English: • One Alaris SmartSite needle-free vial access device for reconstitution
Maltese: • Apparat wieħed ta' Aċċess għall-Kunjett Mingħajr Labra Alaris SmartSite għar-rikostituzzjoni
English: For section 4.4, the CHMP implemented the wording on tardive dyskinesia, agreed upon by the Pharmacovigilance Working Party.
Maltese: Għal sezzjoni 4.4, is-CHMP implimenta l-formolazzjoni ta' kliem fuq diżkajniżja tardiva, li qabel magħha l-Grupp ta' Ħidma dwar il-Farmakoviġilanza.
English: Tonsillitis, Cellulitis, Otitis media, Eye infection, Acarodermatitis, Respiratory tract infection, Onychomycosis, Otitis media chronic Blood and Lymphatic Disorders
Maltese: Tonsillite, Ċellulite, Otite tal-widna tan-nofs, Infezzjoni fl-għajnejn, Akarodermatite, Infezzjoni fl-apprat tan-nifs, Onikomikożi, Otite kronika tal-widna tan-nofs Disturbi tad-Demm u tas-Sistema Limfatika Granuloċitopenja
English: This dose yielded plasma exposures up to 14 times the maximum recommended human dose.
Maltese: Din id-doża wasslet għal esponimenti filplażma sa 14-il darba d-doża massima rakkomandata fil-bnedmin.
English: RISPERDAL CONSTA and associated names (see Annex I) 37.5 mg powder and solvent for prolonged-release suspension for intramuscular injection RISPERDAL CONSTA and associated names (see Annex I) 50 mg powder and solvent for prolongedrelease suspension for intramuscular injection risperidone
Maltese: RISPERDAL CONSTA u ismijiet assoċjati miegħu (ara Anness I) 12.5 mg trab u solvent għal suspensjoni li jerħi l-mediċina bil-mod għall-injezzjoni ġol-muskolu [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Musculoskeletal, Connective Tissue, and Bone Disorders Rhabdomyolysis, Joint swelling, Posture abnormal, Joint stiffness Renal and Urinary Disorders
Maltese: Disturbi Muskolu-skelettrali, tal-Connective Tissue u fl-Għadam Rabdomijaliżi, Nefħa fil-ġogi, Pożizzjoni tal-ġisem mhux normali, Ebusija fil-ġogi Disturb fil-Kliewi u fis-sistema Urinarja
English: Seizures
Maltese: Priapiżmu
English: Skin lesion, Skin disorder, Skin discoloration, Seborrheic dermatitis, Hyperkeratosis, Dandruff, Erythema
Maltese: Sturdament, Sedazzjoni, Ħedla tan-ngħas, Rogħda, Distonijab,, Diskajeżja tardiva, Diskajneżjab,
English: Carbamazepine has been shown to decrease the plasma concentrations of the active antipsychotic fraction of risperidone.
Maltese: Carbamazepine intwera li jnaqqas il-konċentrazzjonijiet fil-plażma tal-porzjon antipsikotiku attiv ta' risperidone.
English: • involuntary rhythmic movements of the tongue, mouth and face.
Maltese: • movimenti involuntarji ritmiċi ta' l-ilsien, tal-ħalq u tal-wiċċ.
English: 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.
Maltese: 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.
English: Muscular weakness, Neck pain, Buttock pain, Musculoskeletal chest pain Endocrine disorders Rare
Maltese: Dgħjufija tal-muskoli, Uġigħ fl-għonq, Uġigħ fil-warrani, Uġigħ muskoluskelettrali fis-sider Disturbi fis-sistema endokrinarja Rari
English: RISPOLEPT CONSTA® Portugal: RISPERDAL® CONSTA® Romania: RISPOLEPT CONSTA® Slovakia: RISPERDAL® CONSTA® Slovenia: RISPERDAL CONSTA® Spain:
Maltese: Effetti sekondarji rari ħafna (jaffettwaw anqas minn persuna waħda li tużah minn kull 10,000) jistgħu jinkludu:
English: No osteodystrophy was observed in dogs treated for 12 months with RISPERDAL CONSTA up to 20 mg/kg/2 weeks.
Maltese: L-ebda osteodistrofija ma kienet osservata fil-klieb kkurati għal 12-il xahar b' RISPERDAL CONSTA f'doża sa 20mg/kg/ġimgħatejn.
English: • Wheezing, pneumonia caused by inhaling food, hoarseness, cough with sputum, lung congestion, breathing passage congestion, crackly lung noise, breathing passage disorder, fast shallow breathing
Maltese: • Diffikultà fit-teħid tan-nifs, infezzjoni fil-pulmun (pulmonite), influwenza, infezzjoni talpassaġġi tan-nifs, infezzjoni fl-apparat ta' l-awrina, żieda fit-temperatura tal-ġisem, inkontinenza ta' l-awrina, infezzjoni fis-sinus, infezzjoni virali infezzjoni fil-widnejn, konġestjoni fl-imnieħer, uġigħ tal-gerżuma, ‘għajn roża', mard bħal ta' l-influwenza, sogħla
English: Šmartinska 53, Ljubljana, Slovenia powder and solvent for suspension for injection
Maltese: Ljubljana, Slovenja injezzjoni
English: 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.
Maltese: 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
English: “For most patients the recommended dose is 25 mg intramuscular every two weeks.
Maltese: “Għall-maġġoranza tal-pazjenti, id-doża rrakkomandata hija ta' 25 mg intramuskolari kull ġimagħtejn.
English: Intestinal obstruction, Pancreatitis Renal and urinary disorders Common
Maltese: Anzjani, indeboliment epatiku u renali
English: Janssen-Cilag Pharmaceuticals Risperdal Consta 50 mg
Maltese: Id-dożaġġ tal-bidu rrakkomandat huwa 25 mg Risperdal Consta kull ġimagħtejn.
English: Additional signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Maltese: XJENTIFIKA TA' RISPERDAL CONSTA U ISMIJIET ASSOĊJATI (ARA L-ANNESS I)
English: Prolonged-release powder (microspheres) and a solvent for suspension for injection
Maltese: Trab li jerħi bil-mod (mikrosferi) u solvent għal suspenzjoni għall injezzjoni
English: • Cimetidie, ranitidine (blockers of the acidity of stomach) If you start or stop taking such medicines you may need a different dose of risperidone
Maltese: • Cimetidie, ranitidine (imblokkaturi ta' l-aċidu ta' l-istonku)
English: Risperdal should be used with caution in patients with pre-existing hyperprolactinaemia and in patients with possibly prolactin-dependent tumours.”
Maltese: Risperdal għandu jintuża bil-kawtela f'pazjenti b'iperprolaktinimja pre-eżistenti u f'pazjenti b'tumuri possibbilment dipendenti fuq prolaktin.”
English: The CHMP predominantly agreed to the proposed grouping of terms of adverse events, but nevertheless considered that “bundle branch block left” should not be separated from “bundle block right” as the different clinical management is not essential.
Maltese: Is-CHMP qabel b'mod prominenti fuq il-ġabra proposta ta' termini ta' episodji avversi, iżda madankollu kkunsidra li “bundle branch block xellugi” m'għandhux ikun separat minn “bundle block lemini” peress li ġestjoni klinika differenti mhijiex essenzjali. “Sedazzjoni” għandha tkun separata minn “sonnolenza” u ma għandhiex tkun raggruppata bit-terminu “sedazzjoni”.
English: Powder and solvent for suspension for injection
Maltese: Trab u solvent għal suspenzjoni għall injezzjoni
English: Agranulocytosis Nervous system disorders Very common Parkinsonismb, Akathisiab, Headache Common
Maltese: Fi studji fuq l-annimali, risperidone u 9-hydroxy-risperidone joħorġu mal-ħalib tas-sider.
English: Starting dose
Maltese: Tapp abjad
English: Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic medicines.
Maltese: Disturbi fil-ħila tal-ġisem li jnaqqas it-temperatura tal-qalba tal-ġisem ġew attribwiti għall-mediċini antipsikotiċi.
English: • Medicines known as beta blockers (used to treat high blood pressure)
Maltese: • Mediċini magħrufa bħala beta blockers (użati biex jikkuraw il-pressjoni għolja)
English: Luxembourg:
Maltese: Slovenja:
English: Vomiting, Diarrhoea, Constipation, Nausea, Abdominal pain, Dyspepsia, Toothache, Dry mouth, Stomach discomfort, Gastritis
Maltese: Rimettar, Dijarea, Stitikezza, Dardir, Uġigħ fl-addome, Dispepsja, Uġigħ fissnien, Ħalq xott, Skomfort fl-istonku, Gastrite
English: • Inability to reach orgasm, ejaculation disorder, menstrual disorder
Maltese: • Inabbiltà li tilħaq orgażmu, disturb fl-eġakulazzjoni, disturb fil-menstrwazzjoni
English: Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be carefully avoided in elderly patients with dementia.
Maltese: Irrispettivament mill-kura, id-deidratazzjoni kienet fattur ta' riskju totali għall-mortalità u għalhekk għandha tingħata attenzjoni biex tiġi evitata f'pazjenti bid-dimenzja.
English: There are no data suggesting kidney-related changes in dogs treated chronically with RISPERDAL CONSTA.
Maltese: M'hemmx dejta li tissuġġerixxi bidliet relatati mal-kliewi fil-klieb ikkurati kronikament b' RISPERDAL CONSTA.
English: Pneumonia, Influenza, Lower respiratory tract infection, Bronchitis, Urinary tract infection, Ear infection, Sinusitis, Viral infection
Maltese: Pulmonite, Influwenza, Infezzjoni tal-parti tan-naħa t'isfel ta' l-apparat tannifs, Bronkite, Infezzjoni fl-apparat ta' l-awrina, Infezzjoni fil-widnejn, Sinożite, Infezzjoni virali
English: A population pharmacokinetic analysis revealed no apparent effect of gender, race or smoking habits on the pharmacokinetics of risperidone or the active antipsychotic fraction.
Maltese: 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.
English: Hypothermia Immune system disorders Uncommon
Maltese: Disturbi fis-sistema immuni Mhux komuni
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton (Pack with ALARIS)
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI [Biex timtela mill-pajjiż partikolari]
English: Flushing
Maltese: Qawwa
English: “Risperdal Consta should not be used in acute exacerbations of schizophrenia without ensuring sufficient antipsychotic coverage with oral risperidone or the previous antipsychotic during the threeweek lag period following the first Risperdal Consta injection.”
Maltese: “Risperdal Consta m'għandux jintuża f'taħrixijiet akuti ta' skiżofrenija mingħajr ma tkun assigurata kopertura antipsikotika biżżejjed b'risperidone orali jew bl-antipsikotiku preċedenti matul il-perijodu ta' differenza ta' tliet ġimgħat wara l-ewwel injezzjoni ta' Risperdal Consta.”
English: According to various treatment guidelines of schizophrenia, the switch of antipsychotic treatment in patients with schizophrenia requires “per se” the increased monitoring of therapy by qualified physicians and the CHMP was therefore of the opinion that due to nature of the illness and long-term experience with treatment of schizophrenia by atypical antipsychotics, proper monitoring of therapy after switching antipsychotic treatment can be expected, without being explicitly mentioned in the SPC.
Maltese: Skond id-diversi linji gwida ta' kura ta' l-iskiżofrenija, il-qlib tal-kura antipsikotika f'pazjenti bi skiżofrenija “per se” teħtieġ żieda fis-sorveljanza tal-kura minn tobba kkwalifikati u s-CHMP kien għalhekk ta' l-opinjoni li minħabba n-natura tal-marda u lesperjenza bil-kura ta' skizofrenija b'antipsikotiċi atipiċi, għandha tkun mistennija sorveljanza xierqa wara l-qlib tal-kura antipsikotika, mingħajr ma din tkun espliċitament imsemmija fl-SPC.
English: Oral antipsychotic supplementation should therefore be given during the first 3 weeks of RISPERDAL CONSTA treatment (see section 4.2).
Maltese: Supplimentazzjoni antipsikotika mill-ħalq għandha għalhekk tingħata waqt l-ewwel 3 ġimgħat ta' kura b' RISPERDAL CONSTA (ara sezzjoni 4.2).
English: Amitriptyline does not affect the pharmacokinetics of risperidone or the active antipsychotic fraction.
Maltese: Amitriptyline ma jaffettwax il-farmakokinetika ta' risperidone jew il-porzjon antipsikotiku attiv.
English: The CHMP further assessed the need for special mention of hyperprolactinaemia and stimulation of cell growth in breast tumours linked to prolactin.
Maltese: Sinjali oħra jistgħu jinkludu mijoglobinurja (rabdomajoliżi) u indeboliment akut tal-kliewi.
English: Anaemia
Maltese: Anemija,
English: 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).
Maltese: 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).
English: Unscrew the syringe from the vial access device.
Maltese: Din il-lista hija indikattiva iżda mhux kompluta.
English: Risperidone binds also to alpha1-adrenergic receptors, and, with lower affinity, to H1-histaminergic and alpha2-adrenergic receptors.
Maltese: Risperidone jeħel ukoll mar-riċetturi alpha1adrenerġiċi u b'anqas affinità ma' riċetturi H1-istaminerġiċi u alpha2-adrenerġiċi.
English: Body temperature increased, Eosinophil count increased, White blood cell count decreased, Haemoglobin decreased, Blood creatine phosphokinase increased, Body temperature decreased
Maltese: Żieda fit-temperatura tal-ġisem, Żieda fl-għadd ta' eosinofils, Tnaqqis fl-għadd ta' ċelluli bojod fid-demm, Tnaqqis fl-emoglobina, Żieda fil-creatine phosphokinase fid-demm, Tnaqqis fit-temperatura tal-ġisem
English: RISPERDAL CONSTA may cause you to gain weight.
Maltese: RISPERDAL CONSTA jista' jġagħlek iżżid fil-piż.
English: Italy:
Maltese: Spanja:
English: • Change in consciousness with increased body temperature and twitching of muscles
Maltese: • Bidla fil-koxjenza b'temperatura tal-ġisem għolja u moviment involontarju f'daqqa tal-muskoli