FrancophonIA/ELRC3.0 huggingface dataset:
English: The apparent volume of distribution is 44.0 ± 3.9 l, suggesting that dexrazoxane distributes mainly in the total body water.
Maltese: Jidher li l-volum tad-distribuzzjoni hu ta' 44.0 ± 3.9 l, li jissuġġerixxi li dexrazoxane jinfirex l-aktar mal-ilma tal-ġisem kollu.
English: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: very common ( 1/10); common ( 1/100 to  1/10); uncommon ( 1/1,000 to  1/100); not known (cannot be estimated from the available data).
Maltese: L-effetti mhux mixtieqa jinsabu mqiegħda f'ordni skont il-frekwenza, bl-aktar frekwenti jitniżżlu lewwel, u qed tintuża l-konvenzjoni li ġejja: komuni ħafna ( 1/10); komuni ( 1/100 sa  1/10); mhux komuni ( 1/1,000 sa  1/100); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: In patients with moderate to severe renal dysfunction (creatinine clearance < 40 ml/min) the dexrazoxane dose should be reduced by 50%.
Maltese: F'pazjenti b'disfunzjoni tal-kliewi minn ħafifa għal gravi (tneħħija tal-kreatinina ta' < 40 ml/min) iddoża ta' dexrazoxane għandha titnaqqas b'50%.
English: Paraesthesia, dizziness, headache, peripheral neuropathy
Maltese: Paraesteżija, sturdament, uġigħ ta' ras, newropatija periferali
English: {(Invented) Name} contains a substance called dexrazoxane.
Maltese: U GĦALXIEX JINTUŻA {Isem (Ivvintat)} fih sustanza msejħa dexrazoxane.
English: The evidence from clinical trials to date suggests increasing cardioprotective benefit from dexrazoxane as the cumulative anthracycline dose is increased.
Maltese: Dexrazoxane ma jipproteġix kontra tossiċitajiet mhux kardijaċi mqanqla minn anthracyclines.
English: The signs and symptoms of overdose are likely to consist of leucopenia, thrombocytopenia, nausea, vomiting, diarrhoea, skin reactions and alopecia.
Maltese: Is-sinjali u s-sintomi ta' doża eċċessiva x'aktarx li jkunu jikkonsistu f'lewkopenija, tromboċitopenija, dardir, rimettar, dijarrea, reazzjonijiet fil-ġilda u alopeċja.
English: Because of the potential for serious adverse reactions in infants exposed to {(Invented) Name}, mothers should discontinue breast-feeding during {(Invented) Name} therapy (see section 4.3).
Maltese: Minħabba li jista' jkun hemm reazzjonijiet avversi serji fi trabi esposti għal {Isem (Ivvintat)}, lommijiet għandhom jieqfu jreddgħu waqt li qed jieħdu t-terapija b'{Isem (Ivvintat)} (ara sezzjoni 4.3).
English: • Of these 76% were treated for breast cancer and 24% for a variety of advanced cancers.
Maltese: • Minn dawn 76% ngħataw kura minħabba kanċer tas-sider u 24% minħabba firxa ta' kanċers avvanzati.
English: Diarrhoea, constipation, abdominal pain, dyspepsia
Maltese: Dijarrea, stitikezza, uġigħ addominali, dispepsja
English: The following are adverse reactions reported when {(Invented) Name} was given at doses around the MTD: neutropenia, thrombocytopenia, nausea, vomiting, and increase in hepatic parameters.
Maltese: Dawn li ġejjin huma r-reazzjonijiet avversi rrappurtati meta {Isem (Ivvintat)} ingħata f'dożi qrib talMTD: newtropenija, tromboċitopenija, dardir, rimettar, żieda fil-parametri tal-fwied.
English: AML has been reported uncommonly in adult breast cancer patients post-marketing (see section 4.8).
Maltese: L-AML kien irrappurtat bħala mhux komuni f'pazjenti adulti morda bil-kanċer tas-sider wara ttqegħid tal-prodott fis-suq (ara sezzjoni 4.8).
English: Prevention of chronic cumulative cardiotoxicity caused by doxorubicin or epirubicin use in advanced and/or metastatic adult breast cancer patients who have received a prior cumulative dose of 300 mg/m2 of doxorubicin or a prior cumulative dose of 540 mg/m2 of epirubicin when further anthracycline treatment is required.
Maltese: Għall-prevenzjoni ta' kardjotossiċità kumulattiva kronika kkawżata bl-użu ta' doxorubicin jew epirubicin f'pazjenti adulti b'kanċer avvanzat u/jew metastatiku tas-sider li ngħataw minn qabel doża kumulattiva ta' 300 mg/m2 doxorubicin jew li ngħataw minn qabel doża kumulattiva ta' 540 mg/m2
English: Febrile bone marrow aplasia, eosinophil count increased, neutrophil count increased, platelet count increased, white blood cell count increased, lymphocyte count decreased, monocyte count decreased Immune system disorders
Maltese: Aplasija febrili tal-mudullun tal-għadam, żieda fl-għadd tal-eosinofili, żieda flgħadd tan-newtrofili, żieda fl-għadd tal-plejtlits, żieda fl-għadd taċ-ċelloli lbojod tad-demm, tnaqqis fl-għadd tal-limfoċiti, tnaqqis fl-għadd tal-monoċiti.
English: Allergic reactions including itching, rash, facial/throat swelling, wheezing, breathlessness or difficult breathing, changes in levels of consciousness, hypotension Sudden onset of shortness of breath, coughing up blood and chest pain (signs of blood clot in the lung)
Maltese: Reazzjonijiet allerġiċi fosthom ħakk, raxx, nefħa fil-wiċċ/grieżem, ħarħir, qtugħ ta' nifs jew diffikultà biex tieħu n-nifs, filli tkun f'sensik filli tintilef minn sensik, pressjoni baxxa Qtugħ ta' nifs għal għarrieda, sogħla bid-demm u uġigħ fis-sider (sinjali ta' emboli fil-pulmun)
English: However prolonged administration of high doses of razoxane, the racemic mixture of which dexrazoxane is the S (+)-enantiomer, has been associated with the development of secondary malignancies (primarily acute myeloid leukaemia).
Maltese: jibqa' jingħata f'dożi qawwija għal tul ta' żmien, it-taħlita raċemika li minnha dexrazoxane huwa S (+)-enantiomer, dehret rabta mal-iżvilupp ta' tumuri malinni sekondarji (primarjament lewkimija limfoblastika akuta).
English: 6.1 List of excipients [To be completed nationally]
Maltese: 6.1 Lista ta' sustanzi mhux attivi
English: Safety profile at maximum tolerated dose
Maltese: Il-profil ta' sigurtà tal-ogħla doża ttollerata
English: Dexrazoxane has been shown to possess mutagenic activity.
Maltese: Intwera li dexrazoxane fih attività mutaġenika.
English: The dose-dependent cardiotoxicity observed during anthracycline administration is due to anthracycline-induced iron-dependent free radical oxidative stress on the relatively unprotected cardiac muscle.
Maltese: Ilkardjotossiċità dipendenti fuq id-doża li dehret waqt li qed jingħata anthracycline hija minħabba stress ossidattiv radikali liberu fuq il-muskolu kardijaku relattivament mhux protett imqanqal minn anthracycline dipendenti fuq il-ħadid.
English: Paediatric population {(Invented) Name} is contraindicated in children and adolescents up to 18 years of age (see section
Maltese: Popolazzjoni pedjatrika {Isem (Ivvintat)} huwa kontraindikat fi tfal u żgħażagħ sa 18-il sena (ara sezzjoni 4.3).
English: Gingivitis, oral candidiasis Hepatobiliary disorders Common
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI [Biex timtela mill-pajjiż partikolari]
English: This substance belongs to a group of medicines which protect the heart (cardioprotective medicines).
Maltese: Din is-sustanza tagħmel parti minn grupp ta' mediċini li jipproteġu l-qalb (mediċini kardjoprotettivi).
English: For men the contraception should be continued for at least 3 months after cessation of treatment with {(Invented) Name} (see section 4.4).
Maltese: Għall-irġiel il-kontraċezzjoni għandha titkompla għal mill-inqas 3 xhur wara li titwaqqaf il-kura b'{Isem (Ivvintat)} (ara sezzjoni 4.4).
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon
Maltese: Neoplażmi beninji, malinni jew mhux speċifikati (inklużi ċisti u qarnit) Mhux komuni
English: Haematological monitoring is thus necessary.
Maltese: Għaldaqstant huwa meħtieġ monitoraġġ ematoloġiku.
English: The difference was not statistically significant and no consistent cause was apparent, however a contribution of dexrazoxane to the difference cannot be ruled out.
Maltese: Id-differenza ma kenitx statistikament sinifikanti u ma dehrex li kien hemm kawża konsistenti, madanakollu wieħed ma jistax jeskludi s-sehem ta' dexrazoxane f'din id-differenza.
English: Pregnancy and breast-feeding
Maltese: Żieda fit-transaminasi
English: • If you are pregnant or plan to become pregnant (see also “Pregnancy and breast-feeding”).
Maltese: • Jekk tqila jew qed tippjana li toħroġ tqila (ara wkoll "Tqala u treddigħ").
English: Due to the spontaneous nature of post-marketing reporting, such events are listed with frequency “not known” if they were not already identified as reactions from clinical trials.
Maltese: Minħabba n-natura spontanja li biha jsiru r-rapporti wara li l-prodott jitqiegħed fis suq, dawn l-episodji qed jidhru bi frekwenza "mhux magħrufa" kemm-il darba ma kenux identifikatidiġà bħala reazzjonijiet waqt il-provi kliniċi.
English: 5000 LT Tilburg The Netherlands
Maltese: 5000 LT Tilburg The L-Olanda
English: • Parkinsonism.
Maltese: • Parkinsoniżmu.
English: Overall mortality
Maltese: Mortalità Totali
English: Cologno Monzese, 20093, Milano, Italy
Maltese: Cologno Monzese, 20093, Milano, L-Italja
English: JANSSEN CILAG, SA Paseo de las 12 estrellas, 5-7 Madrid, Spain
Maltese: JANSSEN CILAG, SA Paseo de las 12 estrellas, 5-7 Madrid, Spanja
English: Karla Engliše 3201/6, 15000 Praha 5, Czech Republic
Maltese: Karla Engliše 3201/6, 15000 Praha 5, Repubblika Ċeka
English: The remainder is inactive metabolites.
Maltese: Il-kumplament huwa metaboliti inattivi.
English: Janssen-Cilag AB c/oVistor hf.Hörgatúni 2 Garðabær, Iceland
Maltese: Janssen-Cilag AB c/oVistor hf.Hörgatúni 2 Garðabær, L-Islanda
English: The volume of distribution is 1-2 l/kg.
Maltese: Il-volum ta' distribuzzjoni huwa ta' 1-2 l/kg.
English: Finland Jansen-Cilag Oy Metsänneidonkuja 8
Maltese: Il-Finlandja Jansen-Cilag Oy Metsänneidonkuja 8
English: Estrada Consiglieri Pedroso 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
Maltese: Estrada Consiglieri Pedroso 69 A - Queluz de Baixo 2734-503 Barcarena
English: Netherlands Janssen-Cilag Dr. Paul Janssenweg 150 PO Box 90240
Maltese: Janssen-Cilag Dr. Paul Janssenweg 150 PO Box 90240
English: Sweden Janssen-Cilag AB Box 7073
Maltese: Janssen-Cilag AB Box 7073
English: Tardive dyskinesia/extrapyramidal symptoms (TD/EPS)
Maltese: Diskajniżja Tardiva/Sintomi Ekstrapiramidali (TD/EPS)
English: Smartinska cesta 53, 1000 Ljubljana, Slovenia
Maltese: Smartinska cesta 53, 1000
English: • Carbamazepine, phenytoin (mdicines for epilepsy)
Maltese: • Carbamazepine, phenytoin (mediċini għall-epilessija)
English: 192 07 Sollentuna Sweden
Maltese: 192 07 Sollentuna
English: Johnson & Johnson d.o.o., Šmartinska 53, Ljubljana, Slovenia
Maltese: Johnson & Johnson d.o.o., Šmartinska 53, Ljubljana, Slovenja
English: Biotransformation and elimination
Maltese: Biotransformazzjoni u eliminazzjoni
English: Vilnius, Lithuania
Maltese: Vilnius, Il-Litwanja
English: • Intentionally disengage the Needle-Pro device
Maltese: • Taqla intenzjonalment l-apparat Needle-Pro
English: Janssen Farmacêutica Portugal Lda.
Maltese: Janssen Farmacêutica IlPortugall Lda.
English: • Antidepressants such as paroxetine, fluoxetines, tricyclic antidepressants
Maltese: • Antidepressanti bħal paroxetine, fluoxetines, antidepressanti triċikliċi
English: The odds ratio (95% exact confidence interval) was 1.21 (0.7, 2.1).
Maltese: Il-porzjon ta' probabbiltà (95% intervall ta' kunfidenza eżatta) kien 1.21 (0.7, 2.1).
English: Janssen-Cilag Pharmaceuticals Aebe Eirinis Avenue 56, Pefki, 15121, Greece
Maltese: Janssen-Cilag Pharmaceuticals Aebe Eirinis Avenue 56, Pefki, 15121, Il-Greċja
English: Johnson & Johnson UAB Sheimynishkiu 1A 09312 Vilnius Lithuania
Maltese: Johnson & Johnson UAB Sheimynishkiu 1A 09312 Vilnius Il-Litwanja
English: Amenorrhoea, Erectile dysfunction, Galactorrhoea
Maltese: Amenorreja, Disfunzjoni erettili, Galaktorreja
English: Anorexia, Polydipsia
Maltese: Anoressja, Polidipsja
English: Lithuania UAB ,,Johnson & Johnson“, Šeimyniškių g. 1A, LT-09312
Maltese: Il-Litwanja UAB ,,Johnson & Johnson“, Šeimyniškių g. 1A, LT-09312
English: The active substance is risperidone.
Maltese: Is-sustanza attiva hija risperidone.
English: Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo Norway
Maltese: In-Norveġja Janssen-Cilag AS Hoffsveien 1D 0275 Oslo In-Norveġja
English: CYP 2D6 is subject to genetic polymorphism.
Maltese: CYP 2D6 huwa suġġett għall-polimorfiżmu ġenetiku.
English: Janssen-Cilag Pharma GmbH Pfarrgasse 75, 1232 Wien, Austria
Maltese: L-Awstrija Janssen-Cilag Pharma GmbH Pfarrgasse 75, 1232 Wien, LAwstrija
English: Norway Janssen-Cilag AS
Maltese: In-Norveġja Janssen-Cilag AS
English: For instructions on preparation and handling RISPERDAL CONSTA, see section 6.6.
Maltese: Għal struzzjonijiet dwar il-preparazzjoni u l-immaniġġar ta' RISPERDAL CONSTA, ara sezzjoni 6.6.
English: Johnson & Johnson D.O.O.
Maltese: Il-Bulgarija Johnson & Johnson D.O.O.
English: Cerebrovascular adverse events (CVAE)
Maltese: Każi avversi ċerebrovaskulari (CVAE)
English: The plasma protein binding of risperidone is 90%; that of the active metabolite 9-hydroxy-risperidone is 77%.
Maltese: It-twaħħil ta' risperidone malproteini tal-plażma huwa ta' 90%; dak ta' 9-hydroxy-risperidone huwa 77%.
English: UAB Johnson&Johnson, Šeimyniškiu g.1A, Vilnius, Lithuania
Maltese: UAB Johnson&Johnson, Šeimyniškiu g.1A, Vilnius, IlLitwanja
English: Neuroleptic malignant syndrome (NMS)
Maltese: Sindrome Newrolettiku Malinn (NMS)
English: In plasma, risperidone is bound to albumin and alpha-1-acid glycoprotein.
Maltese: Fil-plażma, risperidone jeħel ma' l-albumina u ma' alpha1-acid glycoprotein.
English: Atrioventricular block, Tachycardia
Maltese: Imblokk atrijoventikulari, Takikardija
English: Germany Janssen-Cilag GmbH Raiffeisenstr.
Maltese: Janssen-Cilag GmbH Raiffeisenstr.
English: In vitro studies in human liver microsomes showed that risperidone at clinically relevant concentration does not substantially inhibit the metabolism of medicines metabolised by cytochrome P450 isozymes, including CYP 1A2, CYP 2A6, CYP 2C8/9/10, CYP 2D6, CYP 2E1, CYP 3A4, and CYP 3A5.
Maltese: Studji in vitro fil-mikrosomi tal-fwied uman urew li risperidone f'konċentrazzjoni klinikament rilevanti ma jimpedixxix b'mod sostanzjali lmetaboliżmu tal-mediċini mmetabolizzati bl-isozimi taċ-ċitokroma P450, inkluż CYP 1A2, CYP 2A6, CYP 2C8/9/10, CYP 2D6, CYP 2E1, CYP 3A4, u CYP 3A5.
English: Maintenance dose:
Maltese: Doża ta' manteniment:
English: Germany: RISPERDAL CONSTA / Risperidon-Janssen CONSTA Greece:
Maltese: RISPERDAL CONSTA / Risperidon-Janssen CONSTA
English: After repeated intramuscular injections with 25 or 50 mg RISPERDAL CONSTA every two weeks, median trough and peak plasma concentrations of the active antipsychotic fraction fluctuated between 9.9-19.2 ng/ml and 17.9-45.5 ng/ml respectively.
Maltese: Wara injezzjonijiet ripetuti fil-muskolu b' 25 mg jew 50 mg ta' RISPERDAL CONSTA kull ġimgħatejn, il-medjan ta' l-anqas u l-ogħla konċentrazzjonijiet fil-plażma varja bejn 9.9-19.2 ng/ml u 17.9-45.5 ng/ml rispettivament.
English: The mean age (range) of patients who died was 86 years (range 67-100).
Maltese: L-età medja (medda) tal-pazjenti li mietu kienet ta' 86 sena (medda bejn 67-100).
English: FURTHER INFORMATION
Maltese: INFORMAZZJONI IMPORTANTI
English: Thrombocytopenia, Neutropenia
Maltese: Troboċitpenija , Newtropenija
English: The following terms and frequencies are applied: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available clinical trial data).
Maltese: Dawn it-termini u l-frekwenzi li ġejjin huma użati: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), u mhux magħrufa (ma jistgħux jiġu stmati mid-dejta disponibbli mill-provi kliniċi).
English: Angioedema, Pruritus, Acne, Alopecia, Dry skin Musculoskeletal and connective tissue disorders Common
Maltese: Anġjoedima, Ħakk, Akne, Alopeċja, Ġilda xotta Disturbi muskolu-skelettrali u tal-connective tissue Komuni
English: Risperidone is metabolised by CYP 2D6 to 9-hydroxy-risperidone, which has a similar pharmacological activity as risperidone.
Maltese: Risperidone huwa immetabolizzat minn CYP 2D6 f'9-hydroxy-risperidone, li għandu attività farmakoloġika tixbah dik ta' risperidone.
English: For section 4.8, the CHMP assessed and harmonised the wording.
Maltese: Għal sezzjoni 4.8, is-CHMP ivvaluta u armonizza l-formolazzjoni.
English: Enuresis, Dysuria, Pollakiuria
Maltese: Enuresi, Disurja, Pollakijurja
English: RISPERDAL® CONSTA® Belgium: RISPERDAL® CONSTA®/ BELIVON® CONSTA®
Maltese: RISPERDAL® CONSTA® Il-Lussemburgu: RISPERDAL® CONSTA® / BELIVON® CONSTA®
English: Finally, « Extrapyramidal symptoms » should be the grouped term in the subparagraph Nervous System Disorders and the single symptoms should be mentioned with an asterix.
Maltese: Finalment, « Sintomi ekstrapiramidali » għandu jkun it-terminu raggruppat fis-sottoparagrafu Disturbi tas-Sistema Nervuża u s-sintomi singoli għandhom ikunu aċċennati b'asteriks.
English: Risperdal Consta (risperidone) is a benzisoxazole derivative with potent combined serotonin 5HT2A and dopamine D2 receptor-blocking properties.
Maltese: Risperdal Consta (risperidone) huwa derivattiv ta' benzisoxazole b'karatteristiċi qawwijin ta' imblokkar tar-receptor ta' serotonin 5HT2A u dopamine D2 ikkumbinati.
English: In an intramuscular carcinogenicity study with RISPERDAL CONSTA in Wistar (Hannover) rats (doses of 5 and 40 mg/kg/2 weeks), increased incidences of endocrine pancreas, pituitary gland, and adrenal medullary tumours were observed at 40 mg/kg, while mammary gland tumours were present at 5 and 40 mg/kg.
Maltese: Fi studju ta' karċinoġenità ġol-muskolu b'RISPERDAL CONSTA f'firien Wistar (Hannover) (dożi ta' 5 u 40 mg/kg/ġimgħatejn), inċidenzi ogħla ta' tumuri endokrinali tal-frixa, tal-glandola pitwitarja u tal-medulla adrenali kienu osservati f'doża ta' 40 mg/kg, filwaqt li tumuri tal-glandola mammarja kienu preżenti f'doża ta' 5 u 40 mg/kg.
English: Solvent (solution) [To be completed nationally]
Maltese: Solvent (soluzzjoni)
English: No renal tumours occurred in the low dose, the NaCl 0.9%, or the microspheres vehicle control group.
Maltese: L-ebda tumur renali ma seħħ fil-grupp tad-doża l-baxxa, ta' NaCl 0.9%, jew filgrupp ta' kontroll tal-mikrosferi li jġorru d-doża.
English: Janssen-Cilag International NV, Belgium Turnhoutseweg 30, 2340 Beerse, Belgium
Maltese: Janssen-Cilag International NV, Il-Belġju Turnhoutseweg 30, 2340 Beerse, Il-Belġju
English: RISPERDAL does not show a clinically relevant effect on the pharmacokinetics of lithium, valproate, digoxin or topiramate.
Maltese: RISPERDAL ma jurix effett klinikament sinifikanti fuq il-farmakokinetika ta' lithium, valproate, digoxin jew topiramate.
English: The CHMP adopted the following text in section 4.2:
Maltese: Is-CHMP adotta t-test li ġej fis-sezzjoni 4.2:
English: RISPERDAL CONSTA administration to male and female rats for 12 and 24 months produced osteodystrophy at a dose of 40 mg/kg/2 weeks.
Maltese: RISPERDAL CONSTA mogħti lill-firien irġiel u nisa għal 12 u 24 xahar ipproduċa osteodistrofija f'doża ta' 40 mg/kg/ġimgħatejn.
English: Risperidone is a selective monoaminergic antagonist with unique properties.
Maltese: Risperidone huwa antagonist monoaminerġiku selettiv bi kwalitajiet uniċi.
English: The pharmacokinetics of risperidone following single doses of RISPERDAL CONSTA are linear in the dose range of 12.5-75 mg.
Maltese: Il-farmakokinetika ta' risperidone wara dożi waħdiet ta' RISPERDAL CONSTA hija lineari fil-medda tad-doża bejn 12.5-75 mg.
English: In the oral RISPERDAL placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone (7.3%; mean age 89 years, range 75-97) when compared to patients treated with risperidone alone (3.1%; mean age 84 years, range 70-96) or furosemide alone (4.1%; mean age 80 years, range 67-90).
Maltese: Fil-provi kkontrollati bi plaċebo għall-RISPERDAL mill-ħalq f'pazjenti anzjani bid-dimenzja, inċidenza ogħla ta' mortalità kienet osservata f'pazjenti kkurati b'furosemide u risperidone (7.3%; età medja 89 sena, medda 75-97) meta mqabbla ma' pazjenti kkurati b'risperidone waħdu (3.1%; età medja 84 sena, medda 70-96) jew furosemide waħdu (4.1%; età medja 80 sena, limiti 67-90).
English: Do not administer intravenously (see section 4.4 and section 6.6).
Maltese: Tagħtihx ġol-vina (ara sezzjoni 4.4 u sezzjoni 6.6).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially ‘sodiumfree'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol ta' sodium (23 mg) f'kull doża, i.e. huwa essenzjalment ‘mingħajr sodium'.
English: In urine, risperidone plus 9-hydroxy-risperidone represent 35-45% of the orally administered dose.
Maltese: Fl-awrina, risperidone flimkien ma' 9hydroxy-risperidone jirrapreżentaw 35-45% tad-doża mogħtija mill-ħalq.
English: As with other antipsychotics, caution is advised when prescribing risperidone with medicinal products known to prolong the QT interval, e.g., class Ia antiarrhythmics (e.g., quinidine, dysopiramide, procainamide), class III antiarrhythmics (e.g., amiodarone, sotalol), tricyclic antidepressants (i.e., amitriptyline), tetracyclic antidepressant (i.e., maprotiline), some antihistaminics, other antipsychotics, some antimalarials (i.e., chinice and mefloquine), and with medicines causing electrolyte imbalance (hypokalaemia, hypomagnesiaemia), bradycardia, or those which inhibit the hepatic metabolism of risperidone.
Maltese: Bħal b'antipsikotiċi oħrajn, attenzjoni hija rakkomandata meta risperidone jiġi preskritt flimkien ma' prodotti mediċinali magħrufa li jtawwlu l-intervall QT, eż., antiarritmiċi tal-klassi Ia (eż., quinidine, dysopiramide, procainamide), antiarritmiċi tal-klassi III (eż., amiodarone, sotalol), antidepressanti triċikliċi (i.e., amitriptylene), antidepressant tetraċikliku (i.e., maprotilene), xi anti-istaminiċi, antipsikotiċi oħrajn, xi mediċini kontra l-malarja (i.e., chinice u mefloquine), u ma' mediċini oħra li jikkawżaw żbilanċ fl-elettroliti (ipokalimja, ipomagnesimja), bradikardija, jew dawk li jimpedixxu lmetaboliżmu epatiku ta' risperidone.
English: Janssen Pharmaceutica N.V. Turnhoutseweg 30
Maltese: Janssen Pharmaceutica N.V.
English: Verapamil, an inhibitor of CYP 3A4 and P-gp, increases the plasma concentration of risperidone.
Maltese: Verapamil, impeditur ta'CYP 3A4 u ta' P-gp, iżid il-konċentrazzjoni ta' risperidone fil-plażma.
English: No additional benefit was observed with 75 mg in clinical trials.
Maltese: Lebda ġid addizzjonali ma kien osservat b'75 mg fil-provi kliniċi.
English: Each RISPERDAL CONSTA powder and solvent for prolonged-release suspension for injection contains either 12.5 mg, 25 mg, 37.5 mg or 50 mg of risperidone.
Maltese: Trab u solvent RISPERDAL CONSTA għal suspenzjoni li terħi l-mediċina bil-mod għall-injezzjoni fih 12.5 mg, 25 mg, 37.5 mg jew 50 mg ta' risperidone.
English: Bundle branch block, Atrial fibrillation, Bradycardia, Sinus bradycardia, Palpitations Blood and lymphatic system disorders Common
Maltese: Imblokk tal-fergħa bundle, Fibrillazzjoni ta' l-atriju, Bradikardija, Bradikardija tas-sinus, Palpitazzjonijiet Disturbi tad-demm u tas-sistema limfatika
English: The effectiveness of RISPERDAL CONSTA (25 mg and 50 mg) in the management of the manifestations of psychotic disorders (schizophrenia/schizoaffective disorder) was established in one 12-week, placebo-controlled trial in adult psychotic inpatients and outpatients who met the DSM-IV criteria for schizophrenia.
Maltese: L-effikaċja ta' RISPERDAL CONSTA (25 mg u 50 mg) fl-immaniġġar tal-manifestazzjonijiet ta' disturbi psikotiċi (skizofrenja/disturbi skizoaffettivi) kienet stabbilita fi prova waħda ta' 12-il ġimgħa kkontrollata bi plaċebo f'pazjenti adulti psikotiċi fl-isptar u barra li ssodisfaw il-kriterji DSM-IV għall-iskizofrenja.
English: • Rifampicin (a medicine for treating some infections)
Maltese: • Rifampicin (mediċina li tikkura xi infezzjonijiet)
English: The odds ratio (95% exact confidence interval) was 2.96 (1.34, 7.50).
Maltese: Il-porzjon ta' probabbilità (95% intervall ta' kunfidenza eżatta) kien 2.96