FrancophonIA/ELRC3.0 huggingface dataset:
English: All these data were considered sufficient to conclude that Silapo will behave in the same way as Eprex/Erypo in terms of effectiveness and safety in its authorised uses.
Maltese: Din id-data kollha ġiet meqjusa biżżejjed sabiex jiġi konkluż li Silapo ser jaġixxi bl-istess mod bħal Eprex/Erypo f'termini ta' effettività u sigurtà fl-użu approvat tiegħu.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Silapo has a highly similar structure, purity and biological activity to Eprex/Erypo and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Silapo għandu struttura, purità u attività bijoloġika simili ħafna għal Eprex/Erypo u jiġi distribwit bl-istess mod fil-ġisem.
English: • patients with hypertension (high blood pressure) that is not controlled;
Maltese: pazjenti b'ipertensjoni (pressjoni tad-demm għolja) li mhijiex ikkontrollata;
English: During the last 4 weeks of the study haemoglobin levels were around 11.6 g/dl, having risen from around 8.0 g/dl before treatment.
Maltese: Matul l-aħħar erba' ġimgħat tal-istudju, illivelli tal-emoglobina kienu madwar 11.6 g/dl, li żdiedu minn madwar 8.0 g/dl qabel il-kura.
English: The first study compared the effects of Silapo with those of Eprex/Erypo in correcting red blood cell counts in 609 patients over 24 weeks.
Maltese: L-ewwel studju qabbel l-effetti ta' Silapo ma' dawk ta' Eprex/Erypo fil-korrezzjoni tal-għadd ta' ċelloli ħomor tad-demm f'609 pazjenti fuq medda ta' 24 ġimgħa.
English: The active substance in Silapo, epoetin zeta, is a copy of a hormone called erythropoietin, and works in the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow.
Maltese: Is-sustanza attiva f'Silapo, l-epoetina żeta, hija kopja ta' ormon imsejjaħ eritropojetina, u taħdem eżattament bl-istess mod bħall-ormon naturali biex tistimula l-produzzjoni taċ-ċelloli ħomor tad-demm fil-mudullun.
English: Silapo is used when patients are at low or intermediate risk of developing acute myeloid leukaemia and have low levels of the natural hormone erythropoietin.
Maltese: Silapo jintuża meta l-pazjenti jkunu f'riskju baxx jew intermedju li jiżviluppaw lewkimja majelojde akuta u jkollhom livelli baxxi tal-ormon naturali eritropoetina.
English: As for all medicines, data on the use of Silapo are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Silapo hija ssorveljata kontinwament.
English: Studies have also shown that giving Silapo produces similar levels of the active substance in the body to giving Eprex/Erypo.
Maltese: L-istudji wrew ukoll li l-għoti ta' Silapo jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' Eprex/Erypo.
English: It is used in patients with normal blood iron levels who could experience complications from a blood transfusion, if they do not donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood;
Maltese: Jintuża wkoll f'pazjenti b'livelli normali ta' ħadid fid-demm li jistgħu jesperjenzaw kumplikazzjonijiet minn trasfużjoni tad-demm, jekk ma jagħtux id-demm tagħhom stess qabel lintervent kirurġiku u huma mistennija jitilfu bejn 900 u 1,800 ml ta' demm; biex jikkura l-anemija f'adulti b'sindromi majelodisplastiċi (kundizzjonijiet li fihom il-produzzjoni ta' ċelloli tad-demm b'saħħithom tkun difettuża).
English: Pramipexole - Dystonia (EPITT no 18866)
Maltese: Pramipexole - Distonja (EPITT nru 18866)
English: Undesirable effects Skin and subcutaneous tissue disorders Frequency ‘rare': Photosensitivity* *see section c)
Maltese: Ġabra fil-qosor tal-karatteristiċi tal-prodott 4.8. Effetti mhux mixtieqa Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Frekwenza "rari": Fotosensittività* *ara t-taqsima c)
English: Summary of product characteristics 4.4.
Maltese: Ġabra fil-qosor tal-karatteristiċi tal-prodott 4.4.
English: Mesalazine - Risk of photosensitivity reactions (EPITT no
Maltese: Mesalazine - Riskju ta' reazzjonijiet ta' fotosensittività (EPITT nru 18869)
English: - Dystonia2 (inability of keeping your body and neck straight and upright (axial dystonia)).
Maltese: - Distonja2 (L-inabbiltà li żżomm ġismek u għonqok dritti u wieqfa (distonja assjali)).
English: - Dyskinesia
Maltese: - Diskinesja
English: Rare side effects • Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity).
Maltese: • Żieda fis-sensittività tal-ġilda tiegħek għax-xemx u d-dawl ultravjola (fotosensittività).
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/406998/2017
Maltese: EMA/PRAC/600968/2017
English: Adopted at the 29 August-1 September 2017 PRAC
Maltese: Adottati fil-PRAC ta' bejn id-29 ta' Awwissu u l-1 ta' Settembru 2017
English: In particular, you may experience forward flexion of the head and neck (also called antecollis), forward bending of the lower back (also called camptocormia) or sidewards bending of the back (also called pleurothotonus or Pisa Syndrome).
Maltese: B'mod partikolari, inti tista' tesperjenza flessjoni 'l quddiem tar-ras u tal-għonq (imsejħa wkoll antecollis), tgħawwiġ 'il quddiem tan-naħa t'isfel tad-dahar (imsejjaħ ukoll camptocormia) jew tgħawwiġ fil-ġenb tad-dahar (imsejjaħ ukoll pleurothotonus jew Marda ta' Pisa).
English: Although dystonia may be a symptom of Parkinson's disease, the symptoms in these patients have improved after reduction or withdrawal of pramipexole.
Maltese: Minkejja li d-distonja tista' tkun sintomu tal-marda tal-Parkinson, is-sintomi f'dawn ilpazjenti ttejbu wara t-tnaqqis jew l-irtirar ta' pramipexole.
English: EMA/680946/2016 Rev. 1 EMEA/H/A-30/1413
Maltese: EMA/681620/2016 Rev.
English: Durogesic is available in the EU under various trade names including Durogesic DTrans and Durogesic Matrix.
Maltese: Durogesic huwa disponibbli fl-UE taħt diversi ismijiet kummerċjali bħal Durogesic DTrans u Durogesic Matrix.
English: Fentanyl is an opioid (a pain medicine related to morphine).
Maltese: Fentanyl huwa opjojde (mediċina għall-uġigħ relatat mal-morfina).
English: What is Durogesic?
Maltese: X'inhu Durogesic?
English: The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway
Maltese: Is-CMDh huwa korp regolatorju tal-mediċini li jirrappreżenta lill-Istati Membri tal-Unjoni Ewropea (UE), lill-Iżlanda, lilLiechtenstein u lin-Norveġja.
English: The Committee also harmonised other sections of the SmPC including sections 4.6 (fertility, pregnancy and lactation), 4.8 (side effects), and 4.9 (overdose).
Maltese: Il-Kumitat armonizza wkoll sezzjonijiet oħra tal-SmPC inklużi s-sezzjonijiet 4.6 (fertilità, tqala u treddigħ), 4.8 (effetti sekondarji), u 4.9 (doża eċċessiva).
English: The age and general condition of the patient should also be taken into account.
Maltese: L-età u l-kundizzjoni ġenerali tal-pazjent għandhom jitqiesu wkoll.
English: On 15 September 2015, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Durogesic in the EU2.
Maltese: Fil-15 ta' Settembru 2015, il-Kummissjoni Ewropea rreferiet il-kwistjoni lis-CHMP sabiex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Durogesic fl-UE2.
English: The European Commission issued a decision on this opinion on 22/9/16.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni dwar din l-opinjoni fi 22/9/16.
English: These patients should be closely monitored for side effects.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib għal effetti sekondarji.
English: Durogesic was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)1.
Maltese: Durogesic ġie identifikat bħala li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni għal Proċeduri tar-Rikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh)1.
English: On 21 July 2016, the European Medicines Agency completed a review of Durogesic.
Maltese: Fil-21 ta' Lulju 2016, l-Aġenzija Ewropea għall-Mediċini temmet rieżami ta' Durogesic.
English: Durogesic has been authorised in the EU via national procedures.
Maltese: Durogesic ġie awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Durogesic in the European Union (EU).
Maltese: Il-Kumitat għallProdotti Mediċinali għall-Użu mill-Bnedmin (CHMP) tal-Aġenzija kkonkluda li hemm bżonn ta' armonizzazzjoni tal-informazzjoni tal-preskrizzjoni għal Durogesic fl-Unjoni Ewropea (UE).
English: Patients who have serious side effects with Durogesic should be monitored for at least 24 hours after removal of the patch, depending on their symptoms, because the active substance fentanyl remains in the blood for some time and its level only declines slowly (by about half after 24 hours).
Maltese: Il-pazjenti li għandhom effetti sekondarji serji b'Durogesic għandhom jiġu mmonitorjati mill-anqas 24 siegħa wara t-tneħħija tar-roqgħa, skont is-sintomi tagħhom, minħabba li s-sustanza attiva fentanyl tibqa' fid-demm għal xi żmien u l-livell tagħha jonqos bil-mod biss (b'madwar nofs wara 24 siegħa).
English: It contains the active substance fentanyl and is available as a transdermal patch (a patch that gradually delivers the medicine through the skin).
Maltese: Fih is-sustanza attiva fentanyl u huwa disponibbli bħala roqgħa transdermali (roqgħa li tgħaddi l-mediċina b'mod gradwali minn ġol-ġilda).
English: Durogesic patches release enough fentanyl to be fatal if not used appropriately, especially for a child; sufficient fentanyl remains in the patch to cause severe effects even after it has been used.
Maltese: Barra minn hekk, m'għandux jintuża f'pazjenti b'dipressjoni respiratorja severa (problemi biex tieħu nifs), jew f'dawk li huma allerġiċi għal fentanyl jew kwalunkwe ingredjent ieħor ta' Durogesic.
English: The company that markets these medicines is Janssen-Cilag and associated companies.
Maltese: Il-kumpanija li tqiegħed dawn il-mediċini fis-suq hija Janssen-Cilag u kumpaniji assoċjati.
English: The CHMP agreed that Durogesic can be used in adults to treat severe long-term pain that requires continuous treatment with opioid medicines, whether or not the pain is caused by cancer.
Maltese: Is-CHMP jaqbel li Durogesic jista' jintuża fl-adulti sabiex jikkura wġigħ sever fit-tul li jeħtieġ kura kontinwa b'mediċini opjojdi, irrispettivament minn jekk l-uġigħ huwiex ikkawżat mill-kanċer jew le.
English: This section also contains other warnings, including warnings about the risk of respiratory depression, dependence and potential for abuse, and use in children and elderly patients.
Maltese: Din is-sezzjoni fiha wkoll twissijiet oħrajn, inkluż twissijiet dwar ir-riskju ta' dipressjoni respiratorja, dipendenza u potenzjal ta' abbuż, u użu f'pazjenti tfal u anzjani.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Maltese: Dan wassal għal diverġenzi tul l-Istati Membri fil-mod ta' kif tista' tintuża l-mediċina, kif jidher fid-differenzi fis-sommarji tal-karatteristiċi talprodott (SmPCs), it-tikkettar u l-fuljetti ta' tagħrif fil-pajjiżi fejn titqiegħed fis-suq il-mediċina.
English: Depression Insomnia
Maltese: Depressjoni Insomnja
English: • Central nervous system (CNS) depression.
Maltese: • Depressjoni tas-sistema nervuża ċentrali (CNS, central nervous system).
English: 25 mg and 75 mg every 4 weeks).
Maltese: 25 mg u 75 mg kull 4 ġmgħat).
English: posaconazole, saquinavir, verapamil, voriconazole.
Maltese: nefazodone, posaconazole, saquinavir, verapamil, voriconazole.
English: • Progressive supranuclear palsy.
Maltese: • Paraliżi sopranukleari progressiva.
English: ibutilide, quinidine and sotalol)
Maltese: dronedarone, ibutilide, quinidine u sotalol)
English: prochlorperazine, promazine, sertindole, thiorizadine, trifluoperazine, triflupromazine and ziprasidone)
Maltese: promazine, sertindole, thiorizadine, trifluoperazine, triflupromazine u ziprasidone)
English: Cerebrovascular events
Maltese: Avvenimenti ċerbrovaskulari
English: venlafaxine.
Maltese: sertraline, venlafaxine.
English: • Certain antidepressants (e.g. citalopram, escitalopram).
Maltese: • Ċerti antidepressanti (eż. citalopram, escitalopram).
English: • Ketoconazole tablets (to treat Cushing's syndrome)
Maltese: • Pilloli ta' ketoconazole (għat-trattament tas-sindrom ta' Cushing)
English: Class effects of antipsychotics
Maltese: Effetti tal-klassi tal-antipsikotiċi
English: • Class III antiarrhythmics (e.g. amiodarone, dofetilide, dronedarone, ibutilide, sotalol).
Maltese: • Antiarritmiċi tal-klassi III (eż. amiodarone, dofetilide, dronedarone, ibutilide, sotalol).
English: • Class IA antiarrhythmics (e.g. disopyramide, quinidine).
Maltese: • Antiarritmiċi tal-klassi IA (eż. disopyramide, quinidine).
English: • Certain gastrointestinal medicinal products (e.g. dolasetron).
Maltese: • Ċerti prodotti mediċinali gastrointestinali (eż. dolasetron).
English: • Combined CYP3A4 and CYP2D6 inhibitors: fluoxetine, ritonavir.
Maltese: • Inibituri kombinati ta' CYP3A4 u CYP2D6: fluoxetine, ritonavir.
English: See ‘Look out for serious side effects' in section 4.
Maltese: Ara ‘Oqgħod attent/a għal effetti sekondarji serji' f'sezzjoni 4.
English: • Uncertain mechanism - buspirone.
Maltese: • Mekkaniżmu mhux ċert - buspirone.
English: Mean haloperidol plasma protein binding in adults is approximately 88 to 92%.
Maltese: Il-medja tal-irbit ta' haloperidol mal-proteini tal-plażma fl-adulti hija madwar 88 sa 92%.
English: • CYP2D6 inhibitors - bupropion, chlorpromazine, duloxetine, paroxetine, promethazine, sertraline,
Maltese: • Inibituri ta' CYP2D6 - bupropion, chlorpromazine, duloxetine, paroxetine, promethazine,
English: Pharmacotherapeutic group: psycholeptics; antipsychotics; butyrophenone derivatives, ATC code: N05AD01.
Maltese: Kategorija farmakoterapewtika: psikolettiċi; antipsikotiċi; derivati ta' butyrophenone, kodiċi ATC:
English: Iceland, Norway, Sweden:
Maltese: L-Islanda, In-Norveġja, L-Isvezja:
English: • Indinavir, ritonavir or saquinavir (for human immunodeficiency virus or HIV)
Maltese: • Indinavir, ritonavir jew saquinavir (għall-virus tal-immunodefiċjenza umana jew HIV)
English: • Itraconazole, posaconazole or voriconazole (for fungal infections)
Maltese: • Itraconazole, posaconazole jew voriconazole (għal infezzjonijiet bil-fungu)
English: Endocrine system concerns
Maltese: Disturbi fissistema endokrinarja
English: Thyroxin may facilitate haloperidol toxicity.
Maltese: Thyroxin jista' jiffaċilita t-tossiċità ta' haloperidol.
English: Haloperidol is an inhibitor of CYP2D6.
Maltese: Haloperidol huwa inibitur ta' CYP2D6.
English: • CYP3A4 inhibitors - alprazolam, fluvoxamine, indinavir, itraconazole, ketoconazole, nefazodone,
Maltese: • Inibituri ta' CYP3A4 - alprazolam, fluvoxamine, indinavir, itraconazole, ketoconazole,
English: Ventricular fibrillation Torsade de pointes Ventricular tachycardia Extrasystoles
Maltese: Torsade de pointes Takikardija tal-ventrikulu Ekstrasistoli
English: It remains unclear whether this represents a distinct clinical entity.
Maltese: Għadu mhuwiex ċar jekk dan jirrappreżentax entità klinika distinta.
English: • Carbamazepine, phenobarbital or phenytoin (for epilepsy)
Maltese: • Carbamazepine, phenobarbital jew phenytoin (għall-epilessija)
English: Pharmacokinetic/pharmacodynamics relationships
Maltese: Relazzjonijiet farmakokinetiċi/farmakodinamiċi
English: Haldol Decanoate contains the active substance haloperidol (as haloperidol decanoate).
Maltese: Haldol Decanoate fih is-sustanza attiva haloperidol (bħala haloperidol decanoate).
English: Poor metabolisers of CYP2D6
Maltese: Metabolizzaturi dgħajfa ta' CYP2D6
English: • Attention deficit hyperactivity disorder (ADHD) or narcolepsy (known as ‘stimulants')
Maltese: • Għad-disturb ta' nuqqas ta' attenzjoni u attività eċċessiva (ADHD, attention deficit hyperactivity disorder) jew narkolepsija (magħrufa bħala ‘stimulanti')
English: • Depression (‘tricyclic antidepressants')
Maltese: • Għad-depressjoni (‘mediċini triċikliċi kontra d-depressjoni')
English: • Your age
Maltese: • L-età tiegħek
English: Adverse Reaction Frequency
Maltese: Reazzjoni Avversa Frekwenza
English: A serious problem called ‘neuroleptic malignant syndrome'.
Maltese: Problema serja msejħa ‘sindrom newrolettiku malinn'.
English: • Lack of normal facial expression that sometimes looks like a mask.
Maltese: • Nuqqas ta' espressjoni normali tal-wiċċ li xi drabi jidher qisu maskra.
English: • Certain antibiotics (e.g. azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin,
Maltese: • Ċerti antibijotiċi (eż. azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin,
English: Table 3: Adverse reactions System Organ
Maltese: Tabella 3: Reazzjonijiet avversi
English: • Certain antifungals (e.g. pentamidine).
Maltese: • Ċerti antifungali (eż. pentamidine).
English: • Other medicines you are taking.
Maltese: • Mediċini oħra li inti qed tieħu.
English: • Dementia with Lewy bodies.
Maltese: • Dimenzja bil-korpi Lewy.
English: • Malaria (such as halofantrine)
Maltese: • Malarja (bħal halofantrine)
English: • Cancer (such as toremifene and vandetanib).
Maltese: • Kanċer (bħal toremifene u vandetanib).
English: Antagonism of the effect of the anticoagulant phenindione has been reported.
Maltese: Ġie rrappurtat antagoniżmu tal-effett tal-antikoagulant phenindione.
English: • Duloxetine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, St John's Wort
Maltese: • Duloxetine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, St John's Wort (Hypericum, perforatum) jew venlafaxine (għad-depressjoni)
English: Respiratory depression may necessitate artificial respiration.
Maltese: Depressjoni respiratorja tista' tkun teħtieġ respirazzjoni artifiċjali.
English: It is recommended to alternate between the two gluteal muscles.
Maltese: Huwa rrakkomandat li talterna bejn iżżewġ muskoli gluteali.
English: • Alprazolam or buspirone (for anxiety)
Maltese: • Alprazolam jew buspirone (għall-ansjetà)
English: Photosensitivity reaction Urticaria
Maltese: Sensittività eċċessiva
English: • Other antipsychotics (e.g. phenothiazine derivatives, sertindole, pimozide, ziprasidone)
Maltese: • Antipsikotiċi oħra (eż. derivati ta' phenothiazine, sertindole, pimozide, ziprasidone)
English: • Breakdown of muscle tissue (rhabdomyolysis)
Maltese: • Diżintegrazzjoni tat-tessut tal-muskolu (rabdomijolisi)
English: • Certain other medicinal products (e.g. bepridil, methadone).
Maltese: • Ċerti prodotti mediċinali oħra (eż. bepridil, methadone).
English: Based on pooled safety data from these clinical studies, the most commonly reported adverse reactions were: extrapyramidal disorder (14%), tremor (8%), parkinsonism (7%), muscle rigidity (6%) and somnolence (5%).
Maltese: Abbażi ta' ġabra ta' dejta ta' sigurtà minn dawn l-istudji kliniċi, l-aktar reazzjonijiet avversi rrappurtati b'mod komuni kienu: disurb ekstrapiramidali (14%), rogħda (8%), parkinsoniżmu (7%),
English: • Lowering blood pressure (such as guanethidine and methyldopa)
Maltese: • Biex ibaxxu l-pressjoni (bħal guanethidine u methyldopa)
English: Haloperidol has been shown to block the cardiac hERG channel in several published studies in vitro.
Maltese: Haloperidol intwera li jimblokka l-kanal kardijaku hERG in vitro f'diversi studji ppubblikati.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: • Sensitività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: • Reported in clinical studies with haloperidol decanoate.
Maltese: • Irrappurtati fi studji kliniċi b'haloperidol decanoate.
English: Belgium, France, Italy, Luxembourg, Netherlands: Haldol Decanoas Cyprus, Ireland, Malta, United Kingdom:
Maltese: Il-Belġju, Franza, L-Italja, Il-Lussemburgu, L-Olanda:
English: • Certain medicinal products used in cancer (e.g. toremifene, vandetanib).
Maltese: • Ċerti prodotti mediċinali li jintużaw għall-kanċer (eż. toremifene, vandetanib).
English: The central dopamine blocking effect has activity on the basal ganglia (nigrostriatal bundles).
Maltese: L-effett ta' imblokk ċentrali tad-dopamina għandu attività fuq il-ganglia bażali (nigrostriatal bundles).
English: • Reported in clinical studies with haloperidol (non-decanoate formulations) and relate to the active moiety.
Maltese: • Irrappurtati fi studji kliniċi b'haloperidol (il-formulazzjonijiet mhux decanoate) u jikkonċernaw il-parti attiva.
English: Based on limited and sometimes conflicting information, the potential increase in haloperidol plasma concentrations when a CYP3A4 and/or CYP2D6 inhibitor is coadministered may range between 20 to 40%, although in some cases, increases of up to 100% have been reported.
Maltese: Abbażi ta' informazzjoni limitata u xi drabi konfliġġenti, iż-żieda possibbli fil-konċentrazzjonijiet ta' haloperidol fil-plażma meta jingħata inibitur ta' CYP3A4 u/jew CYP2D6 flimkien miegħu tista' tvarja minn 20 sa 40%, għalkemm f'xi każijiet, kienu rrappurtati żidiet sa 100%.
English: Haloperidol apparent clearance after extravascular administration ranges from 0.9 to 1.5 l/h/kg and is reduced in poor metabolisers of CYP2D6.
Maltese: It-tneħħija apparenti ta' haloperidol wara għoti ekstravaskulari tvarja minn 0.9 sa 1.5 l/siegħa/kg u jitnaqqas f'metabolizzaturi dgħajfa ta' CYP2D6.
English: • You will not be given more than 300 mg every 4 weeks.
Maltese: • Inti m'intix se tingħata aktar minn 300 mg kull 4 ġimgħat.
English: Hormonal effects of antipsychotics include hyperprolactinaemia, which may cause galactorrhoea, gynaecomastia and oligomenorrhea or amenorrhoea (see section 4.8).
Maltese: Effetti tal-antipsikotiċi fuq l-ormoni jinkludu iperprolaktinimja, li tista' tikkawża galaktorrea, ġinekomastja, u oligomenorrea jew amenorrea (ara sezzjoni 4.8).
English: After intravenous haloperidol administration, 21% of the dose was eliminated in the faeces and 33% in the urine.
Maltese: Wara għoti ta' haloperidol mill-vini, 21% tad-doża kienet eliminata fl-ippurgar u 33% fl-awrina.
English: Class
Maltese: Klassi tas
English: The cytochrome P450 enzymes CYP3A4 and CYP2D6 are involved in haloperidol metabolism.
Maltese: L-enzimi CYP3A4 u CYP2D6 taċ-ċitokrom P450 huma involuti fil-metaboliżmu ta' haloperidol.
English: Acute hepatic failure Hepatitis
Maltese: Indeboliment akut talfwied
English: • Concomitant treatment with medicinal products that prolong the QT interval (see section 4.5).
Maltese: • Trattament konkomitanti bi prodotti mediċinali li jtawlu l-intervall QT (ara sezzjoni 4.5).
English: This belongs to a group of medicines called ‘antipsychotics'.
Maltese: Din tagħmel parti minn grupp ta' mediċini msejħa ‘antipsikotiċi'.
English: Increases in QTc have been observed when haloperidol was given with a combination of the metabolic inhibitors ketoconazole (400 mg/day) and paroxetine (20 mg/day).
Maltese: (400 mg/kuljum) u paroxetine (20 mg/kuljum).
English: In rare cases the following symptoms were reported during the concomitant use of lithium and haloperidol: encephalopathy, extrapyramidal symptoms, tardive dyskinesia, neuroleptic malignant syndrome, acute brain syndrome and coma.
Maltese: F'każijiet rari is-sintomi li ġejjin kienu rrappurtati waqt l-użu ta' lithium flimkien ma' haloperidol: enċefalopatija, sintomi ekstrapiramidali, diskajneżja tardiva, sindrom newrolettiku malinn, sindrom akut tal-moħħ u koma.
English: Haloperidol decanoate is an ester of haloperidol and decanoic acid, and as such, a depot antipsychotic belonging to the butyrophenones group.
Maltese: Haloperidol decanoate huwa ester ta' haloperidol u decanoic acid, u fil-fatt, antipsikotiku depot li jagħmel parti mill-grupp tal-butyrophenones.
English: Haloperidol is metabolised by several routes (see section 5.2).
Maltese: haloperidol (ara sezzjoni 5.2).