FrancophonIA/ELRC3.0 huggingface dataset:
English: HALDOL Decanoate is contraindicated in combination with medicinal products known to prolong the QTc interval (see section 4.3).
Maltese: HALDOL Decanoate huwa kontraindikat flimkien ma' prodotti mediċinali magħrufa li jtawlu l intervall QTc (ara sezzjoni 4.3).
English: Tardive dyskinesia Convulsion Bradykinesia Hyperkinesia Hypokinesia Dizziness
Maltese: Diskajneżja tardiva Konvulżjoni Bradikajneżja Iperkajneżja Ipokineżja
English: • Severe allergic reactions (adrenaline)
Maltese: • Għal reazzjonijiet allerġiċi severi (adrenalina)
English: Severe allergic reaction that may include:
Maltese: Reazzjoni allerġika severa li tista' tinkludi:
English: Hypotension Orthostatic hypotension
Maltese: Ipotensjoni Ipotensjoni ortostatika
English: • Certain antimalarials (e.g. halofantrine).
Maltese: • Ċerti mediċini kontra l-malarja (eż. halofantrine).
English: The activity on the basal ganglia probably underlies the undesirable extrapyramidal motor effects (dystonia, akathisia and parkinsonism).
Maltese: L-attivita fuq il-ganglia bażali probabbilment hija l-kawża tal-effetti motorji ekstrapiramidali mhux mixtieqa (distonja, akatisja u parkinsoniżmu).
English: • Feel confused (delirium)
Maltese: • Tħossok konfuż/a (delirju)
English: Haloperidol can increase the CNS depression produced by alcohol or CNS-depressant medicinal products, including hypnotics, sedatives or strong analgesics.
Maltese: Haloperidol jista' jżid id-depressjoni tas-CNS ikkaġunata mill-alkoħol jew prodotti mediċinali li jiddepressaw is-CNS, inkluż ipnotiċi, sedattivi jew analġeżiċi qawwija.
English: Analyses of seventeen placebo-controlled studies (modal duration of 10 weeks), largely in patients taking atypical antipsychotics, revealed a risk of death in treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients.
Maltese: Analiżi ta' sbatax-il studju kkontrollati bil-plaċebo (tul ta' żmien modali ta' 10 ġimgħat), laktar f'pazjenti li kienu qed jieħdu antipsikotiċi atipiċi, żvelat riskju ta' mewt bejn 1.6 u 1.7 drabi aktar fil-pazjenti ttrattati mir-riskju ta' mewt fil-pazjenti ttrattati bi plaċebo.
English: A single dose of Haldol Decanoate will normally last for 4 weeks.
Maltese: Doża waħda ta' Haldol Decanoate normalment isservi għal 4 ġimgħat.
English: The antidopaminergic effects of haloperidol on lactotropes in the anterior pituitary explain hyperprolactinaemia due to inhibition of dopamine-mediated tonic inhibition of prolactin secretion.
Maltese: L-effetti antidopaminerġiċi ta' haloperidol fuq il-lactotropes fil-glandola pitwitarja anterjuri jispjegaw l-iperprolaktinimja minħabba inibizzjoni ta' sekrezzjoni tal-prolaktin minn inibizzjoni tonika medjata minn dopamine.
English: Cardiac arrest has been reported with antipsychotics.
Maltese: Kien irrappurtat waqfien kardijaku b'antipsikotiċi.
English: Amenorrhoea Galactorrhoea Dysmenorrhoea Menorrhagia Erectile dysfunction Gynaecomastia Menstrual disorder Breast pain Breast discomfort
Maltese: Jekk taqbeż doża jew tieqaf tuża Haldol Decanoate Inti m'għandekx twaqqaf din il-mediċina sakemm ma jgħidlekx tagħmel dan it-tabib tiegħek minħabba li s-sintomi jistgħu jirritornaw.
English: • Difficulty getting and keeping an erection (impotence)
Maltese: • Diffikultà biex tikseb u żżomm erezzjoni (impotenza)
English: It is recommended that ECG and vital signs be monitored, and that monitoring continues until the ECG is normal.
Maltese: Huwa rrakkomandat li jiġu mmonitorjati l-ECG u s-sinjali vitali, u li l-monitoraġġ jitkompla sakemm l-ECG tkun normali.
English: • Problems with vision, such as blurred vision.
Maltese: • Problemi bil-vista, bħal vista mċajpra.
English: Haloperidol may antagonise the action of adrenaline and other sympathomimetic medicinal products (e.g. stimulants like amphetamines) and reverse the blood pressure-lowering effects of adrenergic-blocking medicinal products such as guanethidine.
Maltese: Haloperidol jista' jantagonizza l-azzjoni tal-adrenalina u prodotti mediċinali simpatomimetiċi oħra (eż. stimulanti bħal amfetamini) u jdawwar bil-maqlub l-effetti ta' tnaqqis tal-pressjoni tad-demm ta'
English: HALDOL Decanoate is indicated for the maintenance treatment of schizophrenia and schizoaffective disorder in adult patients currently stabilised with oral haloperidol (see section 5.1).
Maltese: HALDOL Decanoate huwa indikat għall-manteniment tat-trattament tal-iskiżofrenja u disturb skiżoaffettiv f'pazjenti adulti li fil-preżent ikunu stabbilizzati b'haloperidol mill-ħalq (ara sezzjoni 5.1).
English: Elderly people
Maltese: Adulti
English: In a number of in vivo studies, intravenous administration of haloperidol in some animal models has caused significant QTc prolongation at doses around 0.3 mg/kg, producing Cmax plasma levels at least 7 to 14 times higher than the therapeutic plasma concentrations of 1 to 10 ng/ml that were effective in the majority of patients in clinical studies.
Maltese: F'numru ta' studji in vivo, l-għoti ta' haloperidol mill-vini f'xi annimali bħala mudelli kkawża titwil sinifikanti fl-intervall QTc b'dożi ta' madwar 0.3 mg/kg, li jipproduċu livelli tas-Cmax fil-plażma li kienu millinqas 7 sa 14-il darba aktar mill-konċentrazzjonijiet terapewtiċi ta' 1 sa 10 ng/ml fil-plażma li kienu effettivi fil-biċċa l-kbira tal-pazjenti fi studji kliniċi.
English: Keep this leaflet.
Maltese: Stat ta' konfużjoni
English: The main metabolic pathways of haloperidol in humans include glucuronidation, ketone reduction, oxidative N-dealkylation and formation of pyridinium metabolites.
Maltese: Is-sensiela prinċipali ta' reazzjonijiet metaboliċi ta' haloperidol fil-bnedmin tinkludi glukuronidazzjoni, tnaqqis tal-ketone, N-dealkylation ossidattiva u formazzjoni ta' metaboliti tal-pyridinium.
English: Electrocardiogram QT prolonged, ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia), torsade de pointes and sudden death have been reported with haloperidol.
Maltese: Titwil tal-intervall QT fuq l-elettrokardjogramma, arritmiji tal-ventrikulu (fibrillazzjoni tal-ventrikulu, takikardija tal-ventrikulu), torsade de pointes u mewt zoptu kienu rrappurtati b'haloperidol.
English: Even though impairment of renal function is not expected to affect haloperidol elimination to a clinically relevant extent, caution is advised in patients with renal impairment, and especially those with severe impairment, due to the long half-life of haloperidol and its reduced metabolite, and the possibility of accumulation (see section 4.2).
Maltese: Anke jekk indeboliment tal-funzjoni tal-kliewi mhijiex mistennija li taffettwa l-eliminazzjoni ta' haloperidol sa punt rilevanti b'mod kliniku, hija rrakomandata l-kawtela f'pazjenti b'indeboliment tal-kliewi, u speċjalment dawk b'indeboliment sever tal-kliewi, minħabba l-half-life twila ta' haloperidol u l metabolit imnaqqas tiegħu, u l-possibbiltà ta' akkumulazzjoni (ara sezzjoni 4.2).
English: • Comatose state.
Maltese: • Stat ta' koma.
English: • Nausea and vomiting (such as dolasetron)
Maltese: • Nawsja u rimettar (bħal dolasetron)
English: In patients with first-episode schizophrenia treated with short-acting haloperidol formulations, therapeutic response may be obtained at concentrations as low as 0.6 to 3.2 ng/ml, as estimated based on measurements of D2 receptor occupancy and assuming that a D2 receptor occupancy level of 60 to 80% is most appropriate for obtaining therapeutic response and limiting extrapyramidal symptoms.
Maltese: F'pazjenti bl-ewwel episodju ta' skiżofrenja ttrattati b'formulazzjonijiet ta' haloperidol li jaħdmu għal żmien qasir, rispons terapewtiku jista' jinkiseb b'konċentrazzjonijiet baxxi ta' 0.6 sa 3.2 ng/ml, kif stmat abbażi ta' kejl tal-okkupanza tar-riċettur D2 u jekk wieħed jassumi li livell ta' okkupanza tarriċettur D2 ta' 60 sa 80% huwa l-aktar xieraq biex jinkiseb rispons terapewtiku u jiġu limitati s-sintomi ekstrapiramidali.
English: Haldol Decanoate will be given by a doctor or nurse.
Maltese: Haldol Decanoate se jingħata minn tabib jew infermier.
English: The possible increase in intraocular pressure must be considered when anticholinergic medicinal products, including antiparkinson medicinal products, are administered concomitantly with HALDOL Decanoate.
Maltese: Iż-żieda possibbli fil-pressjoni intraokulari għandha titqies meta prodotti mediċinali antikolinerġiċi, inkluż prodotti mediċinali kontra l-parkinson, jingħataw flimkien ma' HALDOL Decanoate.
English: A doctor or nurse will give this medicine to you, so it is unlikely that you will be given too much.
Maltese: Tabib jew infermier se jagħtuk din il-mediċina, għalhekk mhuwiex probabbli li inti tingħata ż-żejjed.
English: Laryngeal oedema Bronchospasm Laryngospasm Dyspnoea
Maltese: Bronkospażmu Spażmu fil-larinġi
English: Increased haloperidol plasma concentrations may result in an increased risk of adverse events, including QTc-prolongation (see section 4.4).
Maltese: Żieda fil-konċentrazzjonijiet ta' haloperidol fil-plażma tista' twassal għal żieda fir-riskji ta' avvenimenti avversi, inkluż titwil tal-intervall QTc (ara sezzjoni 4.4).
English: Seizures/convulsions
Maltese: Aċċessjonijiet/konvulżjonijiet
English: Haloperidol is a potent central dopamine type 2 receptor antagonist, and at recommended doses, has low alpha-1 antiadrenergic activity and no antihistaminergic or anticholinergic activity.
Maltese: Haloperidol huwa antagonist ċentrali potenti tar-riċettur tat-tip 2 tad-dopamina, u bid-dożi rrakkomandati, għandu attività adrenerġika alpha-1 baxxa u m'għandu l-ebda attività antiistaminerġika jew antikolinerġika.
English: This increase may be higher with all butyrophenones, including haloperidol.
Maltese: Din iż-żieda tista' tkun akbar bilbutyrophenones kollha, inkluż haloperidol.
English: In addition, the safety of haloperidol was evaluated in 284 haloperidol-treated patients who participated in 3 placebo-controlled clinical studies and in 1295 haloperidol-treated patients who participated in 16 double-blind active comparator-controlled clinical studies.
Maltese: Barra dan, is-sigurtà ta' haloperidol ġiet ivvalutata f'284 pazjent ittrattati b'haloperidol li pparteċipaw fi 3 studji kliniċi kkontrollati bil-plaċebo u f'1,295 pazjent ittrattati b'haloperidol li pparteċipaw f'16-il studju kliniku kkontrollati b'kumparatur attiv fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża.
English: For instructions on handling HALDOL Decanoate, see section 6.6.
Maltese: HALDOL Decanoate, ara sezzjoni 6.6. 4.3 Kontraindikazzjonijiet
English: Haloperidol has been associated with neuroleptic malignant syndrome: a rare idiosyncratic response characterized by hyperthermia, generalised muscle rigidity, autonomic instability, altered consciousness and increased serum creatine phosphokinase levels.
Maltese: Haloperidol ġie assoċjat ma' sindrom newrolettiku malinn: rispons idjosinkratiku rari kkaratterizzat minn ipertermja, riġidità mifruxa fil-muskoli, instabbiltà awtonomika, koxjenza mibdula u żieda fil livelli ta' creatine phosphokinase fis-serum.
English: The inter-subject variability (coefficient of variation, %) in haloperidol clearance was estimated to be 44% in a population pharmacokinetic analysis in patients with schizophrenia.
Maltese: Il-varjabilità bejn l-individwi (koeffiċjent ta' varjazzjoni, %) fit-tneħħija ta' haloperidol kienet stmata li hija 44% fl-analiżi farmakokinetika ta'
English: Haloperidol elevates prolactin level.
Maltese: Haloperidol jgħolli l-livelli tal-prolaktin.
English: Rare cases of sudden death have been reported in psychiatric patients receiving antipsychotics, including haloperidol (see section 4.8).
Maltese: Każijiet rari ta' mewt zoptu ġew irrappurtati f'pazjenti psikjatriċi li jkunu qed jirċievu antipsikotiċi, inkluż haloperidol (ara sezzjoni 4.8).
English: • Chlorpromazine or promethazine (for nausea and vomiting)
Maltese: • Chlorpromazine jew promethazine (għad-dardir u r-rimettar)
English: The manifestations of haloperidol overdose are an exaggeration of the known pharmacological effects and adverse reactions.
Maltese: Il-manifestazzjonijiet ta' doża eċċessiva ta' haloperidol huma esaġerazzjoni tal-effetti farmakoloġiċi u r-reazzjonijet avversi magħrufa.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni tal-prodott sussegwentement tista' tiġi aġġustata mill-awtoritajiet kompetenti tal-Istat Membru, flimkien mal-Istat Membru ta' riferenza, skont kif ikun xieraq, skont il-proċeduri mniżżla f'Kapitolu 4 tat-Titolu III tad-Direttiva 2001/83/KE.
English: Investigations
Maltese: tikkontrolla
English: Haldol Decanoate can cause problems with the heart, problems controlling body or limb movements and a serious side effect called ‘neuroleptic malignant syndrome'.
Maltese: Haldol Decanoate jista' jikkawża problemi bil-qalb, problemi bil-kontroll ta' movimenti tal-ġisem jew tad-dirgħajn u r-riġlejn u effett sekondarju serju msejjaħ ‘sindrom newrolettiku malinn'.
English: The effect of CYP3A4 inhibition and of decreased CYP2D6 enzyme activity may be additive (see section 5.2).
Maltese: tnaqqis fl-attività tal-enzima CYP2D6 jista' jkun addittiv (ara sezzjoni 5.2).
English: Haloperidol is rapidly distributed to various tissues and organs, as indicated by the large volume of distribution (mean values 8 to 21 l/kg after intravenous dosing).
Maltese: Haloperidol jiġi ddistribwit malajr f'diversi tessuti u organi, kif indikat permezz tal-volum kbir ta' distibuzzjoni (valuri medji 8 sa 21 l/kg wara għoti ta' dożi ġol-vini).
English: Extrapyramidal symptoms may occur (e.g. tremor, rigidity, hypersalivation, bradykinesia, akathisia, acute dystonia).
Maltese: Jistgħu jseħħu sintomi ekstrapiramidali (eż. rogħda, riġidità, bżieq żejjed, bradikinesja, akatisja, distonja akuta).
English: The metabolites of haloperidol are not considered to make a significant contribution to its activity; however, the reduction pathway accounts approximately for 23% of the biotransformation, and back-conversion of the reduced metabolite of haloperidol to haloperidol cannot be fully ruled out.
Maltese: Il-metaboliti ta' haloperidol mhumiex meqjusa li jagħtu kontribut sinifikanti għall-attività tiegħu; madankollu, is-sensiela ta' reazzjonijiet ta' tnaqqis tirrapreżenta madwar 23% tal-bijotrasformazzjoni, u konverżjoni tal-metabolit imnaqqas ta' haloperidol lura għal haloperidol ma tistax tiġi eskluża kompletament.
English: This association may be stronger for haloperidol than for atypical antipsychotic medicinal products, is most pronounced in the first 30 days after the start of treatment, and persists for at least 6 months.
Maltese: Din l-assoċjazzjoni tista' tkun aktar qawwija għal haloperidol milli għal prodotti mediċinali antipsikotiċi atipiċi, tidher l-aktar fl-ewwel 30 jum wara l-bidu tat-trattament, u tippersisti għal mill-inqas 6 xhur.
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotics.
Maltese: Kienu rrappurati każijiet ta' tromboemboliżmu fil-vini (VTE - venous thromboembolism) b'antipsikotici.
English: Rhabdomyolysis Torticollis
Maltese: Konċentrazzjonijiet terapewtiċi
English: • Psychoses (such as fluphenazine, levomepromazine, perphenazine, pimozide,
Maltese: • Depressjoni (bħal citalopram u escitalopram) • Psikożi (bħal fluphenazine, levomepromazine, perphenazine, pimozide, prochlorperazine,
English: Table 3 lists adverse reactions as follows:
Maltese: Tabella 3 telenka r-reazzjonijiet avversi kif ġej:
English: In randomised, placebo-controlled clinical studies in the dementia population, there was an approximately 3-fold increased risk of cerebrovascular adverse events with some atypical antipsychotics.
Maltese: Fi studji kliniċi, arbitrarji kkontrollati bi plaċebo fil-popolazzjoni bid-dimenzja, kien hemm żieda ta' madwar 3 darbiet fir-riskju ta' avvenimenti ċerebrovaskulari avversi b'xi antipsikotiċi atipiċi.
English: The safety of haloperidol decanoate was evaluated in 410 patients who participated in 3 comparator studies (1 comparing haloperidol decanoate versus fluphenazine and 2 comparing the decanoate formulation to oral haloperidol), 9 open label studies and 1 dose response study.
Maltese: Is-sigurtà ta' haloperidol decanoate ġiet ivvalutata f'410 pazjenti li pparteċipaw fi 3 studji ta' tqabbil bejn mediċini (1 li qabbel haloperidol decanoate versus fluphenazine u 2 li qabblu l-formulazzjoni ta' decanoate mal-formolazzjoni ta' haloperidol mill-ħalq), 9 studji fejn kemm l-investigaturi kif ukoll l individwi kienu jafu liema sustanza qed tintuża u studju wieħed ta' ripons tad-doża.
English: Transition from oral haloperidol • A low haloperidol decanoate dose of 12.5 to 25 mg is recommended.
Maltese: • Hija rrakkomandata doża baxxa ta' 12.5 sa 25 mg ta' haloperidol decanoate.
English: In some animal studies, higher intravenous haloperidol doses of 1 mg/kg or greater caused QTc prolongation and/or ventricular arrhythmias at Cmax plasma levels at least 38 to 137 times higher than the therapeutic plasma concentrations that were effective in the majority of patients in clinical studies.
Maltese: F'xi studji fl-annimali, dożi ogħla ta' haloperidol mill-vini ta' 1 mg/kg jew aktar ikkawżaw titwil fil-intervall QTc u/jew arritmiji tal-ventrikulu f'livelli tas-Cmax fil-plażma li kienu mill-inqas 38 sa 137 darba ogħla mill-konċentrazzjonjiet terapewtiċi fil-plażma li kienu effettivi filmaġġoranza tal-pazjenti fi studji kliniċi.
English: • Based on this conversion, the haloperidol decanoate dose will be 25 to150 mg for most patients.
Maltese: • Abbażi ta' din konverżjoni, id-doża ta' haloperidol decanoate se tkun minn 25 sa 150 mg għall biċċa l-kbira tal-pazjenti.
English: The results are within the observed variability in haloperidol pharmacokinetics.
Maltese: Ir-riżultati qegħdin fil-varjabilità osservata talfarmakokinetika ta' haloperidol.
English: Caution is also required in patients with potentially high plasma concentrations (see section 4.4, Poor metabolisers of CYP2D6).
Maltese: Hija rrakkomandata l-kawtela wkoll f'pazjenti bil-possibbiltà ta' konċentrazzjonijiet għoljin fil-plażma (ara sezzjoni 4.4, Metabolizzaturi dgħajfa ta' CYP2D6).
English: • A haloperidol decanoate dose of 10 to 15 times the previous daily dose of oral haloperidol is recommended.
Maltese: • Hija rrakkomandata doża ta' haloperidol decanoate ta' 10 darbiet sa 15-il darba aktar mid-doża preċedenti ta' kuljum ta' haloperidol mill-ħalq.
English: Adults • Your starting dose will normally be between 25 mg and 150 mg.
Maltese: • Id-doża tiegħek tal-bidu s-soltu tkun bejn 25 mg u 150 mg.
English: Haloperidol inhibits the metabolism of tricyclic antidepressants (e.g. imipramine, desipramine), thereby increasing plasma concentrations of these medicinal products.
Maltese: Haloperidol jinibixxi l-metaboliżmu ta' antidepressanti triċikliċi (eż. imipramine, desipramine), b'hekk iżid il-konċentrazzjonijiet ta' dawn il-prodotti mediċinali fil-plażma.
English: Tachycardia and hypotension (including orthostatic hypotension) have also been reported (see section 4.8).
Maltese: Ġew irrappurati wkoll takikardija u ipotensjoni (inkluż ipotensjoni ortostatika) (ara sezzjoni 4.8).
English: Pancytopenia Agranulocytosis Thrombocytopenia Leukopenia Neutropenia
Maltese: Panċitopenija Agranuloċitożi Tromboċitopenija
English: Tachycardia
Maltese: Stitikezza
English: The cytochrome P450 enzyme system is also involved, particularly CYP3A4 and, to a lesser extent, CYP2D6.
Maltese: Is-sistema tal-enzima taċ-ċitokrom P450 hija involuta wkoll, b'mod partikolari CYP3A4 u, fi grad inqas, CYP2D6.
English: • Verapamil (for blood pressure or heart problems).
Maltese: • Verapamil (għall-pressjoni jew għal problemi tal-qalb).
English: HALDOL Decanoate is not indicated for the treatment of dementia-related behavioural disturbances.
Maltese: HALDOL Decanoate mhuwiex indikat għat-trattament ta' disturbi tal-komportament marbuta maddimenzja.
English: As haloperidol is metabolised by the liver, dose adjustment and caution is advised in patients with hepatic impairment (see sections 4.2 and 5.2).
Maltese: Minħabba li haloperidol jiġi metabolizzat fil-fwied, huma rrakkomandati aġġustament fid-doża u kawtela f'pazjenti b'indeboliment tal-fwied (ara sezzjonijiet 4.2 u 5.2).
English: Metabolic and nutritional disorders
Maltese: Disturbi fil metaboliżmu u n-nutrizzjoni
English: • Abnormal muscle tension
Maltese: • Tensjoni mhux normali fil-muskoli
English: • Rifampicin (for bacterial infections)
Maltese: • Rifampicin (għal infezzjonijiet bil-batterji)
English: HALDOL Decanoate should be used with caution in patients who are known poor metabolisers of cytochrome P450 (CYP) 2D6 and who are coadministered a CYP3A4 inhibitor.
Maltese: HALDOL Decanoate għandu jintuża b'kawtela f'pazjenti li huma magħrufa li huma metabolizzaturi dgħajfa taċ-ċitokrom P450 (CYP) 2D6 u li flimkien miegħu jingħataw inibitur ta' CYP3A4.
English: The syndrome is mainly characterized by rhythmic involuntary movements of the tongue, face, mouth or jaw.
Maltese: Is-sindrom huwa kkaratterizzat l-aktar minn movimenti ritmiċi involontarji tal-ilsien, talwiċċ, tal-ħalq jew tax-xedaq.
English: • Thinning the blood (phenindione).
Maltese: • Biex iraqqu d-demm (phenindione).
English: Inappropriate antidiuretic hormone secretion Hyperprolactinaemia
Maltese: Sekrezzjoni mhux xierqa tal-ormon antidijuretiku Iperprolaktinimja
English: o High level of certain hormones in the blood - ‘prolactin' and ‘antidiuretic hormone' (syndrome of inappropriate antidiuretic hormone secretion) o Low level of sugar in the blood
Maltese: o Livell għoli ta'ċerti ormoni fid-demm - ‘prolaktin' u ‘ormon antidijuretiku' (sindrom ta' sekrezzjoni mhux xierqa tal-ormon antidijuretiku) o Livell baxx ta' zokkor fid-demm
English: Trismus
Maltese: Treddigħ
English: Adverse reaction frequencies are based on (or estimated from) clinical trials or epidemiology studies with haloperidol decanoate, and classified using the following convention:
Maltese: Il-frekwenzi tar-reazzjonijiet avversi huma bbażati fuq (jew stmati minn) provi kliniċi jew studji epidemjoloġiċi b'haloperidol decanoate, u kklassifikati bl-użu tal-konvenzjoni li ġejja::
English: Breastfeeding
Maltese: Anġjoedima
English: Fertility - Haldol Decanoate may increase your levels of a hormone called ‘prolactin', which may affect fertility in men and women.
Maltese: Fertilità - Haldol Decanoate jista' jżid il-livelli tiegħek ta' ormon imsejjaħ ‘prolaktin', li jista' jaffettwa l-fertilità fl-irġiel u n-nisa.
English: Hypotension and circulatory collapse may be counteracted by use of intravenous fluids, plasma or concentrated albumin and vasopressor agents, such as dopamine or noradrenaline.
Maltese: Pressjoni baxxa u kollass ċirkulatorju jistgħu jiġu kontrobattuti bl-użu ta' fluwidi minn ġol-vini, plażma jew albumina kkonċentrata u sustanzi vasopressuri, bħal dopamine jew noradrenaline.
English: • Parkinson's disease (such as levodopa)
Maltese: • Għall-marda ta' Parkinson (bħal levodopa)
English: HALDOL Decanoate and associated names (see Annex I) 50 mg/ml solution for injection HALDOL Decanoate and associated names (see Annex I) 100 mg/ml solution for injection
Maltese: HALDOL Decanoate u ismijiet assoċjati (ara Anness I ) 50 mg/ml soluzzjoni għall-injezzjoni HALDOL Decanoate u ismijiet assoċjati (ara Anness I ) 100 mg/ml soluzzjoni għall-injezzjoni
English: It may be combined with antidepressants to treat those conditions in which depression and psychosis coexist (see section 4.5).
Maltese: Huwa jista' jingħata flimkien ma' antidepressanti biex jitratta dawk il-kondizzjonijiet fejn id-depressjoni u l-psikożi jeżistu flimkien (ara sezzjoni 4.5).
English: Treatment is supportive.
Maltese: It-trattament huwa wieħed ta' sostenn.
English: In a carcinogenicity study of haloperidol, dose-dependent increases in pituitary gland adenomas and mammary gland carcinomas were seen in female mice.
Maltese: Fi studju dwar karċinoġeniċità ta' haloperidol, dehru żidiet dipendenti mid-doża f'adenomi talglandola pitwitarja u karċinomi tal-glandola mammarja fil-ġrieden nisa.